UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 


 

FORM 10-Q

 


 

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

 

For the quarterly period ended SeptemberJune 30, 20222023

 

or

 

TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.

 

For the transition period from             to             

 

Commission File Number: 001-35068

 


 

ACELRX PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 


Delaware

41-2193603

(State or other jurisdiction of
incorporation or organization)

(IRS Employer
Identification No.)

 

25821 Industrial Boulevard,1850 Gateway Drive, Suite 400175

Hayward,San Mateo, CA 9454594404

(650) 216-3500

(Address, including zip code, and telephone number, including area code, of registrants principal executive offices)

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each ClassClass:

Trading symbol(s)

Name of Each Exchange on Which registeredregistered:

Common Stock, $0.001 par value

ACRX

The Nasdaq Global Market

 


 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes  ☒    No  ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).    Yes  ☒    No  ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.:

 

Large accelerated filer

Accelerated filer

    

Non-accelerated filer

Smaller reporting company

    

Emerging growth company

  

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Exchange Act Rule 12b-2)    Yes  ☐    No  ☒

 

As of November 10, 2022,August 7, 2023, the number of outstanding shares of the registrant’s common stock was 7,449,366.16,340,118.

 



 

1

 

 

ACELRX PHARMACEUTICALS, INC.

 

QUARTERLY REPORT ON FORM 10-Q FOR THE QUARTER ENDED SEPTEMBERJUNE 30, 20222023

 

TABLE OF CONTENTS

 

  

Page 

PART I. FINANCIAL INFORMATION          

54

   

Item 1.             

Financial Statements         

54

   
 

Condensed Consolidated Balance Sheets as of SeptemberJune 30, 20222023 (unaudited) and December 31, 20212022         

54

   
 

Condensed Consolidated Statements of Operations for the three and ninesix months ended SeptemberJune 30, 2023 and 2022 (unaudited)         

5

Condensed Consolidated Statements of Stockholders’ Equity (Deficit) for the three and 2021six months ended June 30, 2023 and 2022 (unaudited)         

6

   
 

Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders’ Equity (Deficit)Cash Flows for the three and ninesix months ended SeptemberJune 30, 20222023 and 20212022 (unaudited)         

7

   

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2022 and 2021 (unaudited)         

9

 

Notes to Condensed Consolidated Financial Statements (unaudited)         

108

   

Item 2.             

Management’s Discussion and Analysis of Financial Condition and Results of Operations         

2821

   

Item 3.             

Quantitative and Qualitative Disclosures About Market Risk         

3930

   

Item 4.             

Controls and Procedures         

3930

  

PARTII. OTHER INFORMATION          

4031

   

Item 1.             

Legal Proceedings         

4031

   

Item 1A.         

Risk Factors         

4132

   

Item 2.             

Unregistered Sales of Equity Securities and Use of Proceeds         

7159

   

Item 3.             

Defaults Upon Senior Securities         

7159

   

Item 4.             

Mine Safety Disclosures         

7159

   

Item 5.             

Other Information         

7159

   

Item 6.             

Exhibits         

7260

 

Unless the context indicates otherwise, the terms “AcelRx,” “AcelRx Pharmaceuticals,” “we,” “us” and “our” refer to AcelRx Pharmaceuticals, Inc., and its consolidated subsidiaries. “Niyad” is a trademark, and “ACELRX,” “DSUVIA”, “DZUVEO”“Fedsyra” are trademarks, and “ACELRX” and “Zalviso” are registered trademarks, all owned by AcelRx Pharmaceuticals, Inc. This report also contains trademarks and trade names that are the property of their respective owners.

 

2

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q, or Form 10-Q, contains “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act, which are subject to the “safe harbor” created by that section. The forward-looking statements in this Form 10-Q are contained principally under “Part I. Financial Information - Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Part II. Other Information - Item 1A. Risk Factors”. In some cases, you can identify forward-looking statements by the following words: “may,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “ongoing” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. These statements involve risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Form 10-Q, we caution you that these statements are based on a combination of facts and factors currently known by us and our projections of the future, about which we cannot be certain. Many important factors affect our ability to achieve our objectives, including:

 

 

the accuracy of our estimates regarding the sufficiency of our cash resources, future revenues, expenses, capital requirements and needs for additional financing, and our ability to obtain additional required financing and to continue as a going concern;

 

our ability to manage our operating costs and reduce our cash burn;

 

the uncertainties and impact arising from the worldwide COVID-19 pandemic, including restrictions on the abilityaccuracy of our sales force to contactestimates regarding the sufficiency of our cash resources, future revenues, expenses, and communicate with target customers and resulting delays and challenges to our commercial sales of DSUVIA®

our success in commercializing DSUVIA in the United States, including the marketing, sales, and distribution of the product, whether alone or with contract sales organizations and other collaborators;capital requirements;

 

our ability to identifymaintain listing of our securities trading on the Nasdaq exchange;

the historical performance and secure potential partnerships with a third party having sufficient commercial resources to develophigh volatility in the market price of our common stock;

macroeconomic uncertainties, including inflationary pressures, domestic and potentially growglobal supply chain disruptions, labor shortages, significant volatility in global markets, recession risks and the DSUVIA franchise;worldwide COVID-19 pandemic;

 

our ability to satisfactorily complysecure a potential Emergency Use Authorization for our lead nafamostat developmental product candidate, Niyad™;

our ability to conduct ourselves, or through a contract research organization, clinical trials in a timely and effective manner to advance the development of our product candidates;

our ability to successfully file for and obtain regulatory approval for, and then successfully launch and commercialize our developmental product candidates;

the success of our new corporate partner, Vertical Pharmaceuticals LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, in integrating and commercializing the DSUVIA asset in the United States, including their effectiveness in marketing, sales, and distribution of the DSUVIA product, itself or with U.S. Food and Drug Administration,potential collaborators;

the extent of future sales of DSUVIA by Alora to the Department of Defense, or FDA, regulations concerning the advertising and promotion of DSUVIA;DoD;

 

the size and growth potential of the potential markets for DSUVIA, and our otherdevelopmental product candidates in the United States and in other jurisdictions, and our ability to serve those markets;

 

our ability to maintain regulatory approvalestimates of DSUVIA in the United States, including effective managementexistence of and compliance with the DSUVIA Risk Evaluation and Mitigation Strategies, or REMS, program;

acceptance of DSUVIA by physicians, patients and the healthcare community, including the acceptance of pricing and placement of DSUVIA on payers’ formularies;commercial potential for markets for our developmental product candidates, if approved;

 

our ability to realize the expected benefits and potential value created by the acquisition of Lowell Therapeutics, Inc., or Lowell, for our stockholders, on a timely basis or at all;

our ability to develop, file for and obtain regulatory approval for, and then successfully launch and commercialize products and product candidates that we have in-licensed or acquired;

our ability to file for and secure a potential Emergency Use Authorization for our lead nafamostat product candidate, Niyad™;

 

our ability to develop sales and marketing capabilities in a timely fashion, whether alone through recruiting qualified employees, by engaging a contract sales organization, or with potential future collaborators;

 

successfully establishing and maintaining commercial manufacturing and supply chain relationships with third partydomestic and global third-party service providers;

 

our ability to manage effectively, and the impact of any costs associated with, potential governmental investigations, inquiries, regulatory actions or lawsuits that may be, or have been, brought against us;

 

continued demonstration of an acceptable safety profile of DSUVIA;

effectively competing with other medicationsour ability to obtain adequate government or third-party payer reimbursement for the treatment of moderate-to-severe acute pain in medically supervised settings, including IV-opioids and any subsequently approved products;our developmental product candidates, if approved;

 

our ability to manufacturegain access to formularies and supply DZUVEO® to Laboratoire Aguettant, establish and then maintain effective relationships with pharmaceutical benefit managers and/or Aguettant, in accordance with their forecasts and the License and Commercialization Agreement, or DZUVEO Agreement, with Aguettant, including compliance with any import/export controls or restrictions;

3

the status of the DZUVEO Agreement or any other future potential collaborations, including potential milestones and revenue share payments under the DZUVEO Agreement;

Aguettant’s ability to successfully launch and commercialize DZUVEO in the European Union, or EU;

group purchasing organizations for our or Aguettant’s, ability to maintain regulatory approval of DZUVEO in the EU;

our ability to obtain adequate government or third-party payer reimbursement;developmental product candidates, if approved;

 

our ability to attract additional collaborators with development, regulatory and commercialization expertise;

 

our ability to identify and secure potential commercialstrategic partners to develop, secure regulatory approval for and then commercialize our developmental product candidates;

 

our ability to successfully retain our key commercial, scientific, engineering, medical or management personnel and hire new personnel as needed;

 

existing and future legislation and other regulatory developments in the United States and foreign countries;

 

the performance of our third-party suppliers and manufacturers, including any supply chain impacts or work limitations;

 

the success of competing therapies that are or become available;

our liquidity and capital resources; and

 

our ability to obtain and maintain intellectual property protection for our approved products and product candidates.

 

In addition, you should refer to “Part II. Other Information - Item 1A. Risk Factors” in this Form 10-Q for a discussion of these and other important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. Also, forward-looking statements represent our estimates and assumptions only as of the date of this Form 10-Q. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

 


 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements

AcelRx Pharmaceuticals, Inc.

 

Condensed Consolidated Balance Sheets

(In thousands, except share data)

 

 

September 30,

2022

(unaudited)

 

December 31,

2021(1)

  

June 30, 2023

(unaudited)

 

December 31, 2022(1)

 

Assets

            

Current Assets:

      

Cash and cash equivalents

 $12,732  $7,663  $7,410  $15,275 

Restricted cash

 5,000      5,000 

Short-term investments

 3,194  38,967    495 

Accounts receivable, net

 512  160 

Inventories, net

 874  1,111 

Prepaid expenses and other current assets

  2,228   2,588  1,400  1,865 

Assets of discontinued operations

  26   1,931 

Total current assets

 24,540  50,489  8,836  24,566 

Operating lease right-of-use assets

 3,814  4,302    96 

Property and equipment, net

 10,886  15,928 

In-process research and development asset

 8,819    8,819  8,819 

Other assets

 251  2,174  70  70 

Restricted cash, net of current portion

     5,000 

Assets of discontinued operations

     13,936 

Total assets

 $48,310  $77,893  $17,725  $47,487 

Liabilities, Redeemable Convertible Preferred Stock, and Stockholders Equity (Deficit)

    

Liabilities and Stockholders Equity

        

Current Liabilities:

      

Accounts payable

 $2,003  $2,121  $1,212  $1,256 

Accrued and other liabilities

 4,401  6,524  1,853  2,531 

Long-term debt, current portion

 7,886  8,796    5,363 

Operating lease liabilities, current portion

  1,360   1,068 

Liabilities of discontinued operations

  1,155   4,620 

Total current liabilities

 15,650  18,509  4,220  13,770 

Long-term debt, net of current portion

   5,007 

Deferred revenue, net of current portion

 1,064  1,151 

Operating lease liabilities, net of current portion

 3,228  3,750 

Liability related to the sale of future royalties

   85,288 

Warrant liability

 3,086  7,098 

Other long-term liabilities

  827   81    810 

Liabilities of discontinued operations

     3,995 

Total liabilities

  20,769   113,786   7,306   25,673 

Commitments and Contingencies (Note 10)

       

Series A Redeemable Convertible Preferred Stock, $0.001 par value—10,000,000 shares authorized, 3,000 and 0 issued and outstanding as of September 30, 2022 and December 31, 2021, respectively, with a liquidation preference of $330,000

 315   

Stockholders’ Equity (Deficit):

 

Common stock, $0.001 par value—200,000,000 shares authorized as of September 30, 2022 and December 31, 2021; 7,405,966 and 6,840,967 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively

 7  7 

Commitments and Contingencies

       

Stockholders’ Equity:

     

Common stock, $0.001 par value—200,000,000 shares authorized as of June 30, 2023 and December 31, 2022; 10,994,102 and 8,243,680 shares issued and outstanding as of June 30, 2023 and December 31, 2022, respectively

 11  8 

Additional paid-in capital

 445,564  437,684  448,760  447,635 

Accumulated deficit

  (418,345)  (473,584)  (438,352)  (425,829)

Total stockholders’ equity (deficit)

  27,226   (35,893)

Total liabilities, redeemable convertible preferred stock, and stockholders’ equity (deficit)

 $48,310  $77,893 

Total stockholders’ equity

  10,419   21,814 

Total Liabilities and Stockholders’ Equity

 $17,725  $47,487 

 

(1)

The condensed consolidated balance sheet as of December 31, 20212022 has been derived from the audited consolidated financial statements as of that date included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.2022, which were recast to reflect discontinued operations and filed with the Company’s Current Report on Form 8-K on August 1, 2023.

 

See notes to condensed consolidated financial statements.

 


 

AcelRx Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share data)

 

  

Three Months Ended
September 30,

  

Nine Months Ended
September 30,

 
  

2022

  

2021

  

2022

  

2021

 

Revenue:

                

Product sales

 $507  $160  $1,519  $1,003 

Contract and other collaboration

     1,702      1,813 

Total revenue

  507   1,862   1,519   2,816 
                 

Operating costs and expenses:

                

Cost of goods sold

  569   439   2,229   2,519 

Research and development

  1,308   1,416   4,167   3,109 

Selling, general and administrative

  5,262   8,640   19,422   24,978 

Impairment of property and equipment

        4,901    

Total operating costs and expenses

  7,139   10,495   30,719   30,606 

Loss from operations

  (6,632

)

  (8,633

)

  (29,200

)

  (27,790

)

Other income (expense):

                

Interest expense

  (247

)

  (538

)

  (964

)

  (1,824

)

Interest and other income, net

  140   32   229   92 

Non-cash interest income on liability related to the sale of future royalties

     764   1,136   2,345 

Gain on extinguishment of liability related to the sale of future royalties

        84,052    

Total other (expense) income

  (107

)

  258   84,453   613 

Net (loss) income before income taxes

  (6,739

)

  (8,375

)

  55,253   (27,177

)

Provision for income taxes

  (11

)

     (14

)

  (5

)

Net (loss) income

 $(6,750

)

 $(8,375

)

 $55,239  $(27,182

)

Deemed dividend related to Series A Redeemable Convertible Preferred Stock

  (186)     (186)   

Income allocated to participating securities

        (129)   

Net (loss) income attributable to Common Shareholders, basic

  (6,936

)

  (8,375

)

  54,924   (27,182

)

Net (loss) income per share of common stock, basic

 $(0.94

)

 $(1.40

)

 $7.48  $(4.64

)

Shares used in computing net (loss) income per share of common stock, basic – See Note 14

  7,377,363   5,961,224   7,338,853   5,861,111 

Net (loss) income attributable to Common Shareholders, diluted – See Note 14

  (6,936

)

  (8,375

)

  54,924   (27,182

)

Net (loss) income per share of common stock, diluted

 $(0.94

)

 $(1.40

)

 $7.46  $(4.64

)

Shares used in computing net (loss) income per share of common stock, diluted – See Note 14

  7,377,363   5,961,224   7,367,293   5,861,111 
  Three Months Ended
June 30,
  Six Months Ended
June 30,
 
  2023  2022(1)  2023  2022(1) 

Royalty revenue

 $253  $  $253  $ 

Operating costs and expenses:

                

Research and development

  1,552   1,094   2,599   1,930 

Selling, general and administrative

  2,670   3,960   6,951   8,060 

Impairment of property and equipment

     4,901      4,901 

Total operating costs and expenses

  4,222   9,955   9,550   14,891 

Loss from operations

  (3,969

)

  (9,955

)

  (9,297

)

  (14,891

)

Other income (expense):

                

Interest expense

  (15

)

  (293

)

  (134

)

  (683

)

Interest income and other (expense) income, net

  (441

)

  51   5,070   89 

Non-cash interest income on liability related to the sale of future royalties

     463      1,136 

Gain on extinguishment of liability related to the sale of future royalties

     84,052      84,052 

Total other income (expense)

  (456

)

  84,273   4,936   84,594 

Net income (loss) before income taxes

  (4,425

)

  74,318   (4,361

)

  69,703 

Provision for income taxes

  (3

)

  (3

)

  (3

)

  (3

)

Net income (loss) from continuing operations

  (4,428

)

  74,315   (4,364

)

  69,700 

Net income (loss) from discontinued operations – See Note 3

  57   (3,652

)

  (8,159

)

  (7,711

)

Net income (loss)

  (4,371

)

  70,663   (12,523

)

  61,989 

Income allocated to participating securities

     (7,511

)

     (6,619

)

Net income (loss) attributable to Common Shareholders, basic

 $(4,371

)

 $63,152  $(12,523

)

 $55,370 

Net income (loss) attributable to Common Shareholders, diluted

 $(4,371

)

 $63,155  $(12,523

)

 $55,371 

Net income (loss) per share attributable to stockholders:

                

Basic earnings (loss) per share

                

Income (loss) from continuing operations

 $(0.41

)

 $9.08  $(0.40

)

 $8.62 

Income (loss) from discontinued operations

 $0.01  $(0.50

)

 $(0.75

)

 $(1.06

)

Net income (loss) per share

 $(0.40

)

 $8.58  $(1.15

)

 $7.56 

Diluted earnings (loss) per share

                

Income (loss) from continuing operations

 $(0.41

)

 $9.08  $(0.40

)

 $8.62 

Income (loss) from discontinued operations

 $0.01  $(0.50

)

 $(0.75

)

 $(1.06

)

Net income (loss) per share

 $(0.40

)

 $8.58  $(1.15

)

 $7.56 

Shares used in computing net income (loss) per share of common stock, basic – See Note 9

  10,924,294   7,356,952   10,909,208   7,319,279 

Shares used in computing net income (loss) per share of common stock, diluted – See Note 9

  10,924,294   7,360,453   10,909,208   7,321,022 

(1)

The condensed consolidated statements of operations for the three and six months ended June 30, 2022 have been derived from the unaudited condensed consolidated financial statements for those periods included in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2022, which were recast to reflect discontinued operations and filed with the Company’s Current Report on Form 8-K on August 1, 2023.

 

See notes to condensed consolidated financial statements.

 


 

 

AcelRx Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)

(Unaudited)

(in thousands, except share data)

 

                  

Additional

      

 

Total

 
                  

Paid-in

  

Accumulated

  

Stockholders

 
  

Series A Redeemable Convertible Preferred Stock

  

Common Stock

  

Capital

  

Deficit

  

Equity (Deficit)

 
  

Shares

  

Amount

  

Shares

  

Amount

             
                             

Balance as of December 31, 2021

    $   6,840,967  $7  $437,684  $(473,584) $(35,893)

Stock-based compensation

              783      783 

Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes

        25,769      (58)     (58)

Issuance of common stock in connection with asset acquisition

        481,026      5,511      5,511 

Issuance of common stock upon ESPP purchase

        7,671      58      58 

Net loss

                 (8,674)  (8,674)

Balance as of March 31, 2022

        7,355,433   7   443,978   (482,258)  (38,273)

Stock-based compensation

              753      753 

Issuance of common stock upon vesting of restricted stock units

        11,147             

Net income

                 70,663   70,663 

Balance as of June 30, 2022

        7,366,580   7   444,731   (411,595)  33,143 

Stock-based compensation

              701      701 

Issuance of Series A Redeemable Convertible Preferred Stock and Warrants

  3,000   129         110      110 

Deemed dividends related to Series A Redeemable Convertible Preferred Stock

      186           (186)      (186)

Net proceeds from issuance of common stock in connection with equity financings

        35,900      192      192 

Issuance of common stock upon vesting of restricted stock units

        216             

Issuance of common stock upon ESPP purchase

        3,270      16      16 

Net loss

                 (6,750)  (6,750)

Balance as of September 30, 2022

  3,000  $315   7,405,966  $7  $445,564  $(418,345) $27,226 
  

Common Stock

  Additional
Paid-in
Capital
  

Accumulated
Deficit

  

Total
Stockholders
Equity (Deficit)

 
  

Shares

  

Amount

             

Balance as of December 31, 2022

  8,243,680  $8  $447,635  $(425,829) $21,814 

Stock-based compensation

        569      569 

Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes

  21,700      (22)     (22)

Exercise of prefunded warrants

  2,632,898   2         2 

Issuance of common stock upon ESPP purchase

  26,016   1   30      31 

Net loss

           (8,152)  (8,152)

Balance as of March 31, 2023

  10,924,294   11   448,212   (433,981)  14,242 

Stock-based compensation

        471      471 

Issuance of hold back common stock in connection with asset acquisition

  69,808      77      77 

Net loss

           (4,371)  (4,371)

Balance as of June 30, 2023

  10,994,102  $11  $448,760  $(438,352) $10,419 

 

See notes to condensed consolidated financial statements.

 


AcelRx Pharmaceuticals, Inc.

Condensed Consolidated Statements of Changes in Redeemable Convertible Preferred Stock and Stockholders Equity (Deficit)

(Unaudited)

(in thousands, except share data)

 

Common Stock

  Additional
Paid-in
Capital
  

Accumulated
Deficit

  

Total
Stockholders
Equity (Deficit)

  

Common Stock

 Additional
Paid-in
Capital
 

Accumulated
Deficit

 

Total
Stockholders
Equity (Deficit)

 
 

Shares

 

Amount

             

Shares

 

Amount

            

Balance as of December 31, 2020

 4,940,590  $5  $382,730  $(438,485) $(55,750)

Balance as of December 31, 2021

 6,840,967  $7  $437,684  $(473,584) $(35,893)

Stock-based compensation

     1,089    1,089      783    783 

Issuance of common stock upon vesting of restricted stock units, net of shares withheld for employee taxes

 20,208    (249)   (249) 25,769    (58)   (58)

Net proceeds from issuance of common stock in connection with equity financings

 985,078  1  36,359    36,360 

Issuance of common stock in connection with asset acquisition

 481,026    5,511    5,511 

Issuance of common stock upon ESPP purchase

 9,156    192    192  7,671    58    58 

Issuance of common stock upon exercise of stock options

 106    2    2 

Net loss

           (8,956)  (8,956)       (8,674) (8,674)

Balance as of March 31, 2021

  5,955,138   6   420,123   (447,441)  (27,312)

Balance as of March 31, 2022

 7,355,433  7  443,978  (482,258) (38,273)

Stock-based compensation

     1,172    1,172      753    753 

Issuance of common stock upon vesting of restricted stock units

 3,721          11,147         

Issuance of common stock upon exercise of stock options

 118    2    2 

Net loss

           (9,851)  (9,851)

Balance as of June 30, 2021

  5,958,977   6   421,297   (457,292)  (35,989)

Stock-based compensation

     1,221    1,221 

Issuance of common stock upon vesting of restricted stock units

 389         

Issuance of common stock upon exercise of stock options

 745    13    13 

Issuance of common stock upon ESPP purchase

 5,741    109    109 

Net loss

           (8,375)  (8,375)

Balance as of September 30, 2021

  5,965,852  $6  $422,640  $(465,667) $(43,021)

Net income

           70,663   70,663 

Balance as of June 30, 2022

  7,366,580  $7  $444,731  $(411,595) $33,143 

 

See notes to condensed consolidated financial statements.

 

86

 

AcelRx Pharmaceuticals, Inc.

 

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

 

Nine Months
Ended September 30,

  

Six Months
Ended June 30,

 
 

2022

 

2021

  

2023

 

2022

 

Cash flows from operating activities:

  

Net income (loss)

 $55,239  $(27,182) $(12,523) $61,989 

Adjustments to reconcile net income (loss) to net cash used in operating activities:

  

Non-cash royalty revenue related to royalty monetization

   (83)

Non-cash interest income on liability related to royalty monetization

 (1,136) (2,345)   (1,136)

Depreciation and amortization

 1,305  1,512  311  881 

Non-cash interest expense related to debt financing

 333  607  53  250 

Non-cash issuance of Lowell holdback shares

 (723)  

Stock-based compensation

 2,237  3,482  1,040  1,536 

Non-cash gain on termination of liability related to royalty monetization

 (84,152)  

Non-cash gain on termination of liability related to royalty termination

   (84,152)

Impairment of property and equipment

 4,901      4,901 

Revaluation of warrant liability

 (4,012)  

Impairment of net assets held for sale

 6,935   

Impairment of fixed assets

 1,065   

Gain on termination of lease liabilities

 (1,098)  

Gain on extinguishment of debt liability

 (400)  

Other

 (47) 89  (15) (7)

Changes in operating assets and liabilities:

  

Accounts receivable

 (352) 482  (140) (204)

Inventories

 210  (180) 61  201 

Prepaid expenses and other assets

 375  320  1,119  (212)

Accounts payable

 25  281  (674) 286 

Accrued liabilities

 (1,456) 390  (1,407) (1,582)

Operating lease liabilities

 (357) (559) (146) (402)

Deferred revenue

  (43)  1,188   (29)  (29)

Net cash used in operating activities

  (22,918)  (21,998)  (10,583)  (17,680)

Cash flows from investing activities:

  

Purchase of property and equipment

 (316) (1,799) (100) (158)

Purchase of investments

 (7,369) (53,869)   (7,369)

Sale of the DSUVIA assets

 2,723   

Cash paid for asset acquisition, net of cash acquired

 (1,687)     (1,687)

Proceeds from maturities of investments

  43,162   33,984   500   38,562 

Net cash provided by (used in) investing activities

  33,790   (21,684)

Net cash provided by investing activities

  3,123   29,348 

Cash flows from financing activities:

  

Payment of long-term debt

 (6,250) (6,750) (5,416) (4,166)

Net proceeds from issuance of Issuance of Series A Redeemable Convertible Preferred Stock and Warrants

 239   

Net proceeds from issuance of common stock in connection with equity financings

 192  36,360 

Net proceeds from issuance of common stock in connection with exercise of prefunded warrants

 2   

Net proceeds from issuance of common stock through equity plans

 74  318  31  58 

Payment of employee tax obligations related to vesting of restricted stock units

  (58)  (249)  (22)  (58)

Net cash (used in) provided by financing activities

  (5,803)  29,679 

Net increase (decrease) in cash, cash equivalents and restricted cash

 5,069  (14,003)

Cash, cash equivalents and restricted cash—Beginning of period (See reconciliation in Note 1)

  12,663   27,274 

Cash, cash equivalents and restricted cash—End of period (See reconciliation in Note 1)

 $17,732  $13,271 

Net cash used in financing activities

  (5,405)  (4,166)

Net change in cash, cash equivalents and restricted cash

  (12,865)  7,502 

Cash, cash equivalents and restricted cash—Beginning of period

  20,275   12,663 

Cash, cash equivalents and restricted cash—End of period

 $7,410  $20,165 
  

NONCASH INVESTING ACTIVITIES:

  

Purchases of property and equipment in accounts payable and accrued liabilities

 1,327  703    $1,464 

Liability for held back shares in connection with asset acquisition in other long-term liabilities

 800   

Liability for hold back shares in connection with asset acquisition in other long-term liabilities

   $800 

Issuance of common stock in connection with asset acquisition

 5,511      $5,511 

Establishment of right-of-use asset and lease liability

 85      $85 

 

See notes to condensed consolidated financial statements.

 


 

AcelRx Pharmaceuticals, Inc.

 

Notes to Condensed Consolidated Financial Statements

(Unaudited)

(In thousands, except where otherwise noted)

 

 

1. Organization and Summary of Significant Accounting Policies

 

The Company

 

AcelRx Pharmaceuticals, Inc., or the Company, or AcelRx, was incorporated in Delaware on July 13, 2005 as SuRx, Inc. The Company subsequently changed its name to AcelRx Pharmaceuticals, Inc. The Company’s operations are based in Hayward, California.

 

AcelRx is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings. DSUVIA®(known

On March 12, 2023, the Company entered into an Asset Purchase Agreement, or the Purchase Agreement, with Vertical Pharmaceuticals, LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of AcelRx relating to its sufentanil sublingual tablet product referred to as DZUVEO® in Europe) and Zalviso® areboth focused on the treatment of acute pain, and each utilize sufentanil, delivered via a non-invasive route of sublingual administration, exclusivelyDSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings. Onsettings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a November 2, 2018, 30the U.S. Food and Drug Administration, mcg tablet or FDA, approved DSUVIAother dosage form or strength as reasonably necessary for use in adults in a certified medically supervised healthcare setting, such as hospitals, surgical centers, and emergency departments, for thelifecycle management, of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. The commercial launch of DSUVIA in the United States occurred in the first quarter of 2019. In June 2018, the European Commission, or EC, granted marketing approval of DZUVEO for the management of acute moderate to severe pain in adults in medically monitored settings. AcelRx is further developing a distribution capability and commercial organization to continue to market and sell DSUVIA in the United States. In geographies where AcelRx decides not to commercialize products by itself, the Company may seek to out-license commercialization rights. The Company currently intends to commercialize and promote DSUVIA/DZUVEO outside the United States with one or more strategic partners, and, in July 2021, entered into a License and Commercialization Agreement with Laboratoire Aguettant, or Aguettant, for Aguettant to commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom, or the DZUVEO Agreement. Zalviso was approved in Europe and was commercialized by Grünenthal GmbH, or Grünenthal, throughProduct. The closing of the Purchase Agreement occurred on May 12, 2021April 3, 2023 (see Termination of Grünenthal Agreements below). In July 2022, the European Marketing Authorization for Zalviso was withdrawn. In July 2021, the Company also entered into a separate License and Commercialization Agreement with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution ofNote 3, mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine for injection.“Discontinued Operations”).

 

On January 7, 2022, the Company acquired Lowell Therapeutics, Inc., or Lowell, a privately held company (see Note 4.4, “Asset Acquisition” below),to the consolidated financial statements in the Company’s 2022 Annual Report on Form 10-K for additional information) and, as a result acquired Niyad™, a regional anticoagulant for the dialysis circuit during continuous renal replacement therapy for acute kidney injury patients in the hospital, that the Company plans to study under an investigational device exemption, or IDE, and which has received Breakthrough Device Designation status from the FDA. While not approved for commercial use in the United States, the active drug component of Niyad, nafamostat, has been approved in Japan and South Korea as a regional anticoagulant for the dialysis circuit, disseminated intravascular coagulation, and acute pancreatitis. Niyad is a lyophilized formulation of nafamostat, a broad-spectrum, synthetic serine protease inhibitor, with anticoagulant, anti-inflammatory, and potential anti-viral activities. The second intended indication for Niyad is as a regional anticoagulant for the dialysis circuit for chronic kidney disease patients undergoing intermittent hemodialysis in dialysis centers. In addition, the Company acquired LTX-608, a proprietary nafamostat formulation for direct IV infusion that it intends to develop for the treatment of acute respiratory distress syndrome, or ARDS, and disseminated intravascular coagulation, or DIC.

 

Termination of Grünenthal Agreements

On December 16, 2013, AcelRx and Grünenthal entered into a Collaboration and License Agreement, or the License Agreement, which was amended effective July 17, 2015, and September 20, 2016, or the Amended License Agreement, which granted Grünenthal rights to commercialize the Zalviso PCA system, or the Product, in the 28 European Union, or EU, member states, at the time of the agreement, plus Switzerland, Liechtenstein, Iceland, Norway and Australia (collectively, the Zalviso Territory) for human use in pain treatment within, or dispensed by, hospitals, hospices, nursing homes and other medically supervised settings, (collectively, the Field). In September 2015, the EC granted marketing approval for the marketing authorization application, or MAA, previously submitted to the EMA, for Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. On December 16, 2013, AcelRx and Grünenthal entered into a Manufacture and Supply Agreement, or the MSA, and together with the License Agreement, the Agreements. Under the MSA, the Company exclusively manufactured and supplied the Product to Grünenthal for the Field in the Zalviso Territory. On July 22, 2015, the Company and Grünenthal amended the MSA, or the Amended MSA, effective as of July 17, 2015. The Amended MSA and the Amended License Agreement are referred to as the Grünenthal Agreements.

10

On May 18, 2020, the Company received a notice from Grünenthal that it had exercised its right to terminate the Grünenthal Agreements, effective November 13, 2020. The terms of the Grünenthal Agreements were extended to May 12,14, 2021,to enable Grünenthal to sell down its Zalviso inventory, a right it had under the Grünenthal Agreements. The rights to market and sell Zalviso in the Zalviso Territory reverted back to the Company on May 12, 2021. In July 2022, the European Marketing Authorization for Zalviso was withdrawn.

Termination of Royalty Monetization

On September 18, 2015, the Company sold the majority of the royalty rights and certain commercial sales milestones it was entitled to receive under the Amended License Agreement with Grünenthal to PDL BioPharma, Inc., or PDL, in a transaction referred to as the Royalty Monetization. On August 31, 2020, PDL announced it sold its royalty interest for Zalviso to SWK Funding, LLC, or SWK. On May 31, 2022, the Company entered into a TerminationLicense and Commercialization Agreement, or the PFS Agreement, with SWKLaboratoire Aguettant, or Aguettant, pursuant to fully terminate the Royalty Monetization for which the Company paid cash consideration of $0.1 million. Neither PDL nor SWK retains any further interestobtained the exclusive right to develop and, subject to FDA approval, commercialize in the Royalty Monetization. Accordingly, effectiveUnited States an ephedrine pre-filled syringe, or PFS, containing May 31, 2022, 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine PFS containing 10 ml of a solution of 50 mcg/ml phenylephrine for injection. Aguettant will supply the Royalty Monetization is no longer reflected onCompany with the Company’s consolidated financial statements or other records as a sale of assets to PDL or SWK,products for use in commercialization and, all security interests and other liens of every type held by the parties to the Royalty Monetization have been terminated and automatically released without further action by any party. The $84.1 million gain on extinguishment of the liability related to the sale of future royalties is recognizedif they are approved in the condensed consolidated statements of operations as other income.U.S.

 

Liquidity and Going Concern

 

The unaudited condensed consolidated financial statements for the three and ninesix months ended SeptemberJune 30, 20222023 were prepared on the basis of a going concern, which contemplates that the Company will be able to realize assets and discharge liabilities in the normal course of business. The termination of the Royalty Monetization resulted in net income for the nine months ended September 30, 2022; however, before this, the Company hadhas incurred recurring operating losses and negative cash flows from operating activities since inception and expects to continue to incur operating losses and negative cash flows in the future. These conditions raise substantial doubt aboutAlthough, the Company’s abilityCompany recently closed the private placement of its common stock, pre-funded warrants and common warrants for aggregate gross proceeds to continue as a going concern. Consideringthe Company of $10.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company, with an additional potential $16.3 million upon the exercise of the common warrants, which include an acceleration feature should the Company achieve certain performance milestones (see Note 10, “Subsequent Events”), considering the Company’s current cash resources and its current and expected levels of operating expenses for the next twelve months, management expects to need additional capital to fund its planned operations prior to the 12 month anniversary of the date this Quarterly Report on Form 10-Q is filed with the United States Securities and Exchange Commission, or the SEC. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management may seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, debt securities, monetizea new debt facility, monetizing or securitizesecuritizing certain assets, refinance its loan agreement, enterentering into product development, license or distribution agreements with third parties, or divest DSUVIA in the United States, DZUVEO in Europe, ordivesting any of the Company’s remaining product candidates. While management believes its plans to raise additional funds will alleviate the conditions that raise substantial doubt about the Company’s ability to continue as a going concern, these plans are not entirely within the Company’s control and cannot be assessed as being probable of occurring. Additional funds may not be available when the Company needs them on terms that are acceptable to the Company, or at all. If adequate funds are not available, the Company may be required to further reduce its workforce reduce the scope of, or cease, the commercial launch of DSUVIA, or delay the development of its regulatory filing plans for its product candidates in advance of the date on which the Company’s cash resources are exhausted to ensure that the Company has sufficient capital to meet its obligations and continue on a path designed to preserve stockholder value. In addition, if additional funds are raised through collaborations, strategic alliances or licensing arrangements with third parties, the Company may have to relinquish rights to its technologies, future revenue streams or product candidates, or to grant licenses on terms that may not be favorable to the Company.

 

8

Reverse Stock Split

 

On September 23, 2022, at a special meeting of stockholders, the Company's stockholders authorized the Company’s Board of Directors to effect a reverse stock split of all outstanding shares of common stock in a range of 1-for-10-for-10 to 1-for-30. The Board of Directors subsequently approved a reverse stock split with a ratio of 1-for-20, or the Reverse Stock Split. On October 25, 2022, following the filing of a certificate of amendment to the Company’s amended and restated certificate of incorporation, every 20 shares of the Company's common stock that were issued and outstanding automatically converted into one outstanding share of common stock. The Reverse Stock Split affected all shares of common stock outstanding immediately prior to the effective time of the Reverse Stock Split, as well as the number of shares of common stock available for issuance under the Company's equity incentive and employee stock purchase plans. Outstanding stock options, restricted stock units and warrants were proportionately reduced and the respective exercise prices, if applicable, were proportionately increased. The Reverse Stock Split affected all holders of common stock uniformly and did not affect any stockholder's percentage of ownership interest. The par value of the Company's common stock remained unchanged at $0.001 per share and the number of authorized shares of common stock remained the same after the Reverse Stock Split.

 

11

As the par value per share of the Company's common stock remained unchanged at $0.001$0.001 per share, the change in the common stock recorded at par value has been reclassified to additional paid-in-capital on a retroactive basis. All references to shares of common stock, stock options, restricted stock units and warrants and per share data for all periods presented in the accompanying unaudited condensed consolidated financial statements and notes thereto have been adjusted to reflect the Reverse Stock Split on a retroactive basis.

 

Principles of Consolidation

 

The unaudited condensed consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated in consolidation.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States for interim financial information and the rules and regulations of the United States. Securities and Exchange Commission, or SEC. Accordingly, they do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.

 

Operating results for the three and ninesix months ended SeptemberJune 30, 2022,2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2022,2023, or any future period. The unaudited condensed consolidated balance sheet as of December 31, 2021,2022, was derived from the Company’s consolidated audited financial statements as of December 31, 2021,2022, included in the Company’s Annual Report on Form 10-K filed with the SEC on March 10, 2022.31, 2023, which were recast to reflect discontinued operations and filed with the Company’s Current Report on Form 8-K on August 1, 2023. These condensed consolidated financial statements should be read in conjunction with the Company’s Annual Report on Form 10-K for the year ended December 31, 2021,2022, which includes a broader discussion of the Company’s business and the risks inherent therein.

Reclassifications

Certain prior year amounts in the consolidated financial statements have been reclassified to conform to the current year's presentation. In particular, the restricted cash classified as “Cash and cash equivalents” has been reclassified to “Restricted cash, net of current portion” in the condensed consolidated balance sheets as of December 31, 2021 and in the condensed consolidated statement of cash flows as of December 31, 2021, September 30, 2021 and December 31, 2020. See “—Cash, Cash Equivalents and Restricted Cash” below.

 

Use of Estimates

 

The preparation of financial statements in conformity with accounting principles generally accepted in the United States or GAAP, requires management to make estimates and assumptions that affect the amounts reported in the unaudited condensed consolidated financial statements and accompanying notes. Management evaluates its estimates on an ongoing basis including critical accounting policies. Estimates are based on historical experience and on various other market-specific and other relevant assumptions that the Company believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates.

 

Cash, Cash Equivalents and Restricted Cash

The Company considers all highly liquid investments with an original maturity (at date of purchase) of three months or less to be cash equivalents. Cash and cash equivalents consist of cash on deposit with banks.

On May 30, 2019, the Company entered into a Loan Agreement with Oxford Finance LLC, or Oxford, or the Lender. The Loan Agreement requires that the Company always maintain unrestricted cash of not less than $5.0 million in accounts subject to control agreements in favor of the Lender, tested monthly as of the last day of the month. The Company has classified these unrestricted funds as restricted cash on the condensed consolidated balance sheets.

129

 

The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets that sum to the total of the same such amounts in the condensed consolidated statement of cash flows:

  

Balance as of

 
  

September 30, 2022

  

December 31, 2021

 

Cash and cash equivalents

 $12,732  $7,663 

Restricted cash

  5,000    

Restricted cash, net of current portion

     5,000 

Total cash, cash equivalents, and restricted cash

 $17,732  $12,663 

  

Balance as of

 
  

September 30, 2021

  

December 31, 2020

 

Cash and cash equivalents

 $8,271  $22,274 

Restricted cash

  5,000   5,000 

Total cash, cash equivalents, and restricted cash

 $13,271  $27,274 

Restructuring CostsRecently Adopted Accounting Pronouncements

The Company's restructuring costs consist of employee termination benefit costs. Liabilities for costs associated with the cost reduction plan are recognized when the liability is incurred and are measured at fair value. One-time termination benefits are expensed at the date the Company notifies the employee, unless the employee must provide future service, in which case the benefits are expensed ratably over the future service period.

 

In May 2022,June 2016, the Company initiated a reorganization that eliminated approximately 40% of its employees, primarily withinFinancial Accounting Standards Board, or FASB, issued Topic 326, or the commercial organization. For the nine months ended September 30, 2022, Credit Losses standard, which the Company incurred approximately $0.5 million in employee termination benefitsadopted using a modified retrospective approach on January 1, 2023. Topic 326 requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value. The adoption of this standard did not have a material impact on the Company’s financial statements or related to this restructuring, alldisclosures.

The Company does not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on the consolidated financial position, statements of which has been paid. This headcount reduction was completed in the second quarter of 2022.No additional expenses are anticipated in connection with this cost reduction plan.operations and cash flows.

 

Significant Accounting Policies

 

The Company’s significant accounting policies are detailed in its Annual Report on Form 10-K for the year ended December 31, 2021.2022. There have been no significant changes to the Company’s significant accounting policies during the ninethree and six months ended SeptemberJune 30, 2022,2023, from those previously disclosed in its 20212022 Annual Report on Form 10-K, except as follows:

 

AcquisitionsRoyalty Revenue

 

The Company recognizes revenue in accordance with Accounting Standards Codification Topic 606,Revenue from Contracts with Customers (ASC 606). The Company applies the following five steps in order to determine the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements:

identify the contract with a customer;

identify the performance obligations in the contract;

determine the transaction price;

allocate the transaction price to performance obligations in the contract; and

recognize revenue as the performance obligation is satisfied.

The Company’s royalty revenue relates to the Company’s portion of net revenue earned on the sales of DSUVIA to the Department of Defense or DoD by Alora under the Marketing Agreement. The Company’s performance obligation is to serve as the exclusive sales agent for selling DSUVIA to the DoD through the term of the Marketing Agreement. The non-creditable and non-refundable royalty revenues are variable consideration based on 75% of net sales of DSUVIA to the DoD during the period subject to certain adjustments. The Company evaluates acquisitions of assets and other similar transactions to assess whetherif it is a principal or not thean agent in a transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially allrevenue should be recorded on a gross or net basis depending on if it obtains control over the goods and services before they are transferred to customers. The Company is acting as an agent in relation to DSUVIA sales to the DoD.

The consideration in the Marketing Agreement reflects a variable amount, for which the Company estimates the amount of consideration to which it will be entitled in exchange for transferring the promised goods or services to a customer by using the expected value method or the most likely amount method. The Company includes in the transaction price the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. Royalty revenues are recognized when the DoD obtains control of the fair value of the gross assets acquired is concentrated in a single identifiable asset or group of similar identifiable assets. If so, the transaction is accounted for as an asset acquisition. If not, further determination is required as to whether or notproduct, at which time the Company has acquired inputs and processes that have the abilityan unconditional right to create outputs, which would meet the definition of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Acquisitions meeting the definition of business combinations are accountedreceive payment for using the acquisition method of accounting, which requires that the purchase price be allocated to the net assets acquired at their respective fair values. In a business combination, any excess of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.

For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. The Company also evaluates which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use: (a) the Company must reasonably expect that it will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) the Company’s use of the asset acquired is not contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed. Asset acquisitions may include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.such royalty earned.

 

13

Net Income (Loss) per Share of Common StockDiscontinued Operations

 

BasicIn accordance with ASC 205-20Presentation of Financial Statements: Discontinued Operations”, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and dilutedfinancial results. In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the continuing operations. At the same time, the results of all discontinued operations, less applicable income taxes, shall be reported as components of net loss separate from the net income (loss) per common share, or EPS, are calculated in accordance with the provisions of FASB ASC Topic 260,Earnings per Share.continuing operations.

 

The Company’s Series A Redeemable Convertible Preferred Stock issued during the quarter ended September 30, 2022, DSUVIA business met the definition of a participating security given their rights to participate in dividends if declared on common stock, which requiresdiscontinued operation as of March 31, 2023. Accordingly, the Company to applyhas classified the two-class method to compute both basicresults of the DSUVIA business as discontinued operations in its unaudited condensed consolidated statements of operations for all periods presented. All assets and diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securitiesliabilities associated with the DSUVIA business were classified as having rights to earnings that would otherwise have been available to common stockholders. In addition, as these securities are participating securities,assets and liabilities of discontinued operations in the Company is required to calculate diluted net income or loss per share underunaudited condensed consolidated balance sheets for the if-converted methodperiods presented. All amounts included in additionthe notes to the two-class method and utilize the most dilutive result. In periods where there is a net loss, no allocation of undistributed net lossunaudited condensed consolidated financial statements relate to the Series A Redeemable Convertible Preferred stockholders is performed as the holders of these securities are not contractually obligated to participate in the Company’s losses.

continuing operations unless otherwise noted. For additional information, regarding the net income (loss) per share, see Note 143, “Net Income (Loss) per Share of Common Stock”“Discontinued Operations”.

Recently Issued Accounting Pronouncements

Recently issued accounting pronouncements whose adoption may impact the Company are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. There have been no significant changes to recently issued accounting pronouncements whose adoption may impact the Company during the nine months ended September 30, 2022, from those previously disclosed in the Company’s 2021 Annual Report on Form 10-K.

 

 

2. Investments and Fair Value Measurement

 

Investments

 

The Company classifies its marketable securities as available-for-saleavailable for sale and records its investments at fair value. Available-for-sale securities are carried at estimated fair value based on quoted market prices or observable market inputs of almost identical assets, with the unrealized holding gains and losses included in accumulated other comprehensive income (loss). Marketable securities which have maturities beyond one year as of the end of the reporting period are classified as non-current.

The table below summarizes the Company’s cash, cash equivalents, restricted cash and short-term investments (in thousands):

  

As of September 30, 2022

 
  

Amortized Cost

  

Gross Unrealized
Gains

  

Gross Unrealized
Losses

  

Fair
Value

 

Cash, cash equivalents and restricted cash:

                

Cash

 $4,533  $  $  $4,533 

Money market funds

  113         113 

U.S. government agency securities

  7,193         7,193 

Commercial paper

  5,893         5,893 

Total cash, cash equivalents and restricted cash

  17,732         17,732 
                 

Short-term investments:

                

Commercial paper

  3,194         3,194 

Total short-term investments

  3,194         3,194 

Total cash, cash equivalents, restricted cash and short-term investments

 $20,926  $  $  $20,926 

14

 
  

As of December 31, 2021

 
  

Amortized Cost

  

Gross Unrealized
Gains

  

Gross Unrealized
Losses

  

Fair
Value

 

Cash, cash equivalents and restricted cash:

                

Cash

 $1,443  $  $  $1,443 

Money market funds

  2,822         2,822 

Commercial paper

  8,398         8,398 

Total cash, cash equivalents and restricted cash

  12,663         12,663 
                 

Short-term investments:

                

Commercial paper

  29,504         29,504 

Corporate debt securities

  9,463         9,463 

Total short-term investments

  38,967         38,967 

Total cash, cash equivalents, restricted cash and short-term investments

 $51,630  $  $  $51,630 

There were no other-than-temporary impairments for these securities at September 30, 2022 or December 31,2021. No gross realized gains or losses were recognized on the available-for-sale securities and, accordingly, there were no amounts reclassified out of accumulated other comprehensive income (loss) to earnings during the three and nine months ended September 30, 2022 and 2021.

 

As of SeptemberJune 30, 2022,2023, and December 31, 2021,2022, the contractual maturity of all investments held was less than one year.

 

The tables below summarize the Company’s cash, cash equivalents and short-term investments (in thousands):

  

As of June 30, 2023

 
  

Amortized Cost

  

Gross Unrealized
Gains

  

Gross Unrealized
Losses

  

Fair
Value

 

Cash, cash equivalents and restricted cash:

                

Cash

 $2,641  $  $  $2,641 

Money market funds

  3,872         3,872 

U.S. government agency securities

  597         597 

Commercial paper

  300         300 
                 

Total cash, cash equivalents, and restricted cash

 $7,410  $  $  $7,410 

10

 
  

As of December 31, 2022

 
  

Amortized Cost

  

Gross Unrealized
Gains

  

Gross Unrealized
Losses

  

Fair
Value

 

Cash, cash equivalents and restricted cash:

                

Cash

 $13,275  $  $  $13,275 

Money market funds

  321         321 

U.S. government agency securities

  2,444         2,444 

Commercial paper

  4,235         4,235 

Total cash, cash equivalents and restricted cash

  20,275         20,275 
                 

Short-term investments:

                

Commercial paper

  495         495 

Total short-term investments

  495         495 

Total cash, cash equivalents, restricted cash and short-term investments

 $20,770  $  $  $20,770 

At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic conditions. There were no material realized or unrealized gains or losses on marketable securities for the three and six months ended June 30, 2023 or the twelve months ended December 31, 2022. As such, we did not record a credit allowance for the three and six months ended June 30, 2023.

Fair Value Measurement

 

The Company’s financial instruments consist of Level I and II assets and Level III liabilities.assets. Money market funds are highly liquid investments and are actively traded. The pricing information on these investment instruments are readily available and can be independently validated as of the measurement date. This approach results in the classification of these securities as Level 1 of the fair value hierarchy. For Level II instruments, the Company estimates fair value by utilizing third party-party pricing services in developing fair value measurements where fair value is based on valuation methodologies such as models using observable market inputs, including benchmark yields, reported trades, broker/dealer quotes, bids, offers and other reference data. Such Level II instruments typically include U.S. treasury,Treasury, U.S. government agency securities and commercial paper. As of SeptemberJune 30, 2022,2023 and December 31, 2021,2022, the Company held, in addition to Level II assets, a contingent put optionwarrant liability associated withrelated to the Loan Agreement with Oxford, determined to be a Level III instrument.2022 Warrants (see Note 12, “Warrants” in the Company’s 2022 Annual Report on Form 10-K for further description). The Company’s estimate of fair value of the contingent put optionwarrant liability was determined byestimated using a risk-neutral valuation model, wherein the Black Scholes Model which uses as inputs the following weighted average assumptions: dividend yield, expected term in years; equity volatility; and risk-free interest rate (see Note 7, “Warrants” below). The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value of the underlying debt facility is estimated both with and without the presence of the default provisions, holding all other assumptions constant.at each reporting period. The resulting difference between the two estimated fair values is the estimated fair value of the default provisions, or the contingent put option.warrant liability represents a Level III measurement. Changes to the estimated fair value of this liability isthese liabilities are recorded in interest income and other income, net in the unaudited condensed consolidated statements of operations. The fair value of the underlying debt facility is estimated by calculating the expected cash flows in consideration of an estimated probability of default and expected recovery rate in default and discounting such cash flows back to the reporting date using a risk-free rate.

 

11

The following table setstables set forth the fair value of the Company’s financial assets and liabilities by level within the fair value hierarchy (in thousands):

 

 

As of September 30, 2022

  

As of June 30, 2023

 
 

Fair Value

 

Level I

 

Level II

 

Level III

  

Fair Value

 

Level I

 

Level II

 

Level III

 

Assets

                

Money market funds

 $113  $113  $  $  $3,872  $3,872  $  $ 

U.S. government agency securities

 7,193    7,193    597    597   

Commercial paper

  9,087      9,087      300      300    

Total assets measured at fair value

 $16,393  $113  $16,280  $  $4,769  $3,872  $897  $ 
  

Liabilities

                

Contingent put option liability

 $27  $  $  $27 

Warrant liability

 $3,086  $  $  $3,086 

Total liabilities measured at fair value

 $27  $  $  $27  $3,086  $  $  $3,086 

 

15

 
  

As of December 31, 2021

 
  

Fair Value

  

Level I

  

Level II

  

Level III

 

Assets

                

Money market funds

 $2,822  $2,822  $  $ 

Commercial paper

  37,902      37,902    

Corporate debt securities

  9,463      9,463    

Total assets measured at fair value

 $50,187  $2,822  $47,365  $ 
                 

Liabilities

                

Contingent put option liability

 $81  $  $  $81 

Total liabilities measured at fair value

 $81  $  $  $81 
  

As of December 31, 2022

 
  

Fair Value

  

Level I

  

Level II

  

Level III

 

Assets

                

Money market funds

 $321  $321  $  $ 

U.S. government agency securities

  2,444      2,444    

Commercial paper

  4,730      4,730    

Total assets measured at fair value

 $7,495  $321  $7,174  $ 
                 

Liabilities

                

Warrant liability

 $7,098  $  $  $7,098 

Total liabilities measured at fair value

 $7,098  $  $  $7,098 

 

The following tables settable sets forth a summary of the changes in the fair value of the Company’s Level III financial liabilitieswarrant liability for the three and ninesix months ended SeptemberJune 30, 2022 2023 (and 2021 (inin thousands):

 

  

Three Months
Ended
September 30,
2022

  

Nine Months
Ended
September 30,
2022

 

Fair value—beginning of period

 $49  $81 

Change in fair value of contingent put option associated with the Loan Agreement

  (22

)

  (54

)

Fair value—end of period

 $27  $27 

 

Three Months
Ended
September 30,
2021

  

Nine Months
Ended
September 30,
2021

  

Three Months Ended

June 30, 2023

  

Six Months Ended
June 30, 2023

 

Fair value—beginning of period

 $128  $246  $1,787  $7,098 

Change in fair value of contingent put option associated with the Loan Agreement

  (19

)

  (137

)

Change in fair value of 2022 Warrants liability

  1,299   (4,012

)

Fair value—end of period

 $109  $109  $3,086  $3,086 

 

There were no transfers between Level I, Level II or Level III of the fair value hierarchy during the three and ninesix months ended SeptemberJune 30, 20222023 and the year ended 2021.December 31, 2022.

 

 

3. Inventories, netDiscontinued Operations

 

Inventories consistAsset Purchase Agreement

On April 3, 2023, the Company, closed the transactions contemplated by the Purchase Agreement entered into on March 12, 2023, with Alora, pursuant to which Alora agreed to acquire certain assets and assume certain liabilities of raw materials, workAcelRx relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in processmedically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product. The Product expressly excludes the pharmaceutical product referred to as Zalviso (sufentanil sublingual tablets, each 15 mcg), any other multi-dose administration system containing sufentanil sublingual tablets (whether as the sole active ingredient or in combination with other active ingredients), and finished goods and are stated atany single-dose formulation of sufentanil for use outside of a medically supervised setting. With the lower of cost or net realizable value and consistclosing of the following (in thousands):

  

Balance as of

 
  

September 30, 2022

  

December 31, 2021

 

Raw materials

 $773  $722 

Work-in-process

     159 

Finished goods

  101   230 

Total

 $874  $1,111 

The Company did not recordtransaction, AcelRx is entitled to receive (a) up to $116.5 million in sales-based milestones, (b) quarterly payments in an amount equal to 15% of net sales based on sales of Product to all customers, other than sales to the United States Department of Defense, or DoD, under the Marketing Agreement (as defined below), pursuant to which Alora will pay AcelRx 75% of Product net sales to the DoD, and sales by or on behalf of Laboratoire Aguettant, or Aguettant, and (c) 20% of any inventory impairment charges for theconsideration, excluding royalty payments based on sales of Product and subject to customary exclusions, received by Alora or its affiliates in connection with a grant to any threethird and nine months ended September 30, 2022. The Company recorded inventory impairment chargesparty of $0.1 million and $0.2 million for the three and nine months ended September 30, 2021, respectively, primarilya license related to DSUVIA and Zalviso component parts inventory.Product, or by Alora or its affiliates or equityholders in connection with a sale or transfer to any third party of an ownership interest in any assets acquired by Alora under the Purchase Agreement.

 

1612

The Purchase Agreement contains customary representations, warranties, and covenants by each party. Alora agreed 4.not Asset Acquisition

Onto practice, license or otherwise exploit any of the intellectual property rights acquired by it under the Purchase Agreement to manufacture, develop or commercialize any product (other than Product) that is or has been commercialized by AcelRx or its affiliate as of the date of the Purchase Agreement, or any product that is competitive with any such product. In addition, Alora will use commercially reasonable efforts to maintain regulatory approvals for and commercialize Product in the United States. If Alora (together with other relevant parties, taken as a whole) fails to commercialize, sell and distribute Product within the January 7, 2022, six-month period beginning on July 1, 2023, then all rights granted to Alora pursuant to the Company closed its acquisitionPurchase Agreement will, upon AcelRx’s written notice, revert back to AcelRx. The Purchase Agreement also contains indemnification rights for each of LowellAcelRx and acquired the product nafamostat,Alora for breaches of representations, warranties, and the associated patents and historical know-how. The acquisition was valued at approximately $32.5 million plus cash acquired of $3.5 million andcovenants, as well as certain other adjustments. All optionsmatters, subject to purchase capital stock and all shares of Lowell capital stock issued and outstanding immediately before the effective time of the merger were cancelled in exchange for the right to receive (i) 450,477 shares of AcelRx common stock issued at a five day daily volume weighted average price of $11.46 per share as of January 7, 2022, or the Acquisition Date, valued at $5.2 million on closing, (ii) cash in the amount of $3.5 million, (iii) 69,808 shares of AcelRx common stock to be held back to satisfy any potential indemnification and other obligations of Lowell and its securityholders valued at $0.8 million, (iv) $0.5 million cash and stock paid for sellers’ transaction costs and (v) up to $26.0 million of contingent consideration payable in cash or stock at AcelRx's option, upon the achievement of regulatory and sales-based milestones.certain specified limitations.

 

The shares issuedClosing included the execution of the Amended DZUVEO Agreement (as defined below) and the Amended and Restated Supply Agreement (as defined below) between AcelRx and Aguettant, as well as certain ancillary agreements between AcelRx and Alora. Such ancillary agreements include (a) an intellectual property agreement, pursuant to which Alora granted fully-paid, royalty-free and perpetual licenses to AcelRx under certain specified intellectual property rights acquired by Alora under the Purchase Agreement for, among other things, the development, manufacture, commercialization and exploitation of certain products, including Zalviso, (b) a transition services agreement, pursuant to which, during the period specified therein, AcelRx will be paid to provide certain services (including, manufacturing technology transfer, supply chain, regulatory, and medical affairs services) to Alora, and distribute, on behalf of Alora, certain inventory of Product transferred to Alora under the Purchase Agreement, and (c) a marketing agreement, or the Marketing Agreement, pursuant to which AcelRx will have the exclusive right to market and offer Product for sale to DoD and Alora will pay to AcelRx 75% of net sales of Product sold to DoD, subject to adjustment in certain circumstances.  

Amendments to Certain Agreements Between AcelRx and Aguettant

AcelRx and Aguettant are parties to (a) the License and Commercialization Agreement, dated July 14, 2021, pursuant to which Aguettant obtained the exclusive right to develop and commercialize DZUVEO in certain European countries for the management of acute moderate to severe pain in adults in medically monitored settings, or the DZUVEO Agreement, and (b) the supply agreement, dated December 6, 2021, with respect to the manufacture and supply of DZUVEO in form of bulk product by AcelRx to Aguettant, or the Supply Agreement. Pursuant to the Purchase Agreement, AcelRx and Aguettant entered into an amendment to the DZUVEO Agreement, or the Amended DZUVEO Agreement, and an amendment and restatement to the Supply Agreement, or the Amended and Restated Supply Agreement.

Pursuant to the Amended DZUVEO Agreement, (a) Aguettant’s obligations to make sales-based milestone payments and to achieve certain levels of minimum sales terminated, (b) AcelRx agreed to manufacture and supply DZUVEO in the merger were issuedform of bulk products (i.e., products that are pre-packaged in labeled pouches and packed in bright stock cartons for shipment) to Aguettant or its affiliates or sublicensees, and Aguettant will be responsible for manufacturing finished products from bulk products, before Aguettant establishes a private placement semi-automated packaging line for Product, and (c) after Aguettant has established such semi-automated packaging line, AcelRx will cause DZUVEO to be manufactured and supplied in the form of bulk tablets (i.e., products in tablet forms supplied in bulk (not packaged) quantities) to Aguettant or its affiliates or sublicensees, and Aguettant will be responsible for manufacturing finished products from bulk tablets. The Amended and Restated Supply Agreement will govern the manufacture and supply of DZUVEO in the form of bulk products or bulk tablets, and contain customary terms, including those with respect to manufacturing requirements, forecast, delivery, and post-delivery inspection.

Pursuant to the Purchase Agreement, AcelRx assigned the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement to Alora.

In addition, AcelRx and Aguettant amended the License and Commercialization Agreement, dated July 14, 2021, pursuant to which AcelRx obtained exclusive rights to develop and commercialize certain ephedrine pre-filled syringe and certain phenylephrine prefilled syringe in the exemption from registration under SectionUnited States, or the PFS Agreement (see Note 4,(a)( “In-License Agreement” below).

213)

The Company’s DSUVIA business met the definition of a discontinued operation as of March 31, 2023. Accordingly, the assets and liabilities associated with these operations have been classified as assets and liabilities of discontinued operations in the accompanying condensed consolidated balance sheets at June 30, 2023 and December 31, 2022. The operations and cash flows of the Securities Act of 1933,DSUVIA business are presented as amended, or the Securities Act, including Rule 506 of Regulation D promulgated under the Securities Act, or Regulation D, without general solicitation as a transaction not involving any public offering.discontinued for all periods presented.

 

The merger has been accounted for as an asset acquisition of a single IPR&D asset that has an alternative future use. The initial measurementfollowing table presents the results of the asset purchased of $8.8 million was based ondiscontinued operations for the purchase cost of $12.4 million including (i) $6.0 million common stock fair value on the closing date (issuedthree- and held back on the acquisition date), (ii) $0.5 million seller’s costs paid by the Company, (iii) $3.5 million cash six-month periods ended June 30, 2023 and (iv) approximately $2.5 million of transaction costs less purchase price allocated to cash acquired of $3.5 million. Due to the nature of regulatory and sales-based milestones, the contingent consideration of up to $26.0 million was not2022 included in the initial cost of the assets purchased as they are contingent upon events that are outside the Company’s control, such as regulatory approvals and issuance of patents, and are not considered probable until notification is received. However, upon achievement or anticipated achievement of each milestone, the Company shall recognize the related, appropriate payment as an additional cost of the acquired IPR&D asset. As of September 30, 2022, none of the contingent events has occurred.(in thousands):

  

Three months ended

  

Six months ended

 
  

June 30,

  

June 30,

 
  

2023

  

2022

  

2023

  

2022

 

Total revenues

 $  $570  $501  $1,012 

Cost of goods sold

     538   711   952 

Selling, general and administrative expense

  15   3,234   698   6,842 

Impairment of net assets held for sale

  (72)     6,935    

Impairment of fixed assets

        1,065    

Gain on termination of lease liabilities

        (1,098)   

Research and development expenses

     450   349   929 

Net income (loss) from discontinued operations

 $57  $(3,652) $(8,159) $(7,711)

 

The following table summarizes the total considerationcarrying amounts of major classes of assets and liabilities of discontinued operations for the acquisition and the valueeach of the IPR&D asset acquiredperiods presented (in thousands):.

 

Consideration

    

Cash

 $3,536 

Issuance of common stock to Lowell security holders in connection with asset acquisition

  5,161 

Issuance of common stock to settle Lowell’s transaction costs in connection with asset acquisition

  350 

Liability for issuance of 69,808 hold back shares to Lowell securityholders(1)

  800 

Transaction costs

  2,521 

Total consideration

 $12,368 
     
     

IPR&D Asset Acquired

    

Purchase price

 $12,368 

Cash acquired

  (3,549)

Total IPR&D asset acquired(2)

 $8,819 

(1) Recorded as Other long-term liabilities in the condensed consolidated balance sheets.

(2) Recorded as In-process research and development asset in the condensed consolidated balance sheets.

The IPR&D asset will be initially accounted for as an indefinite-lived asset, and as a long-lived asset, it will be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. If the IPR&D asset achieves regulatory approval and the asset life is determined to be finite, the asset’s useful life will be estimated, and the asset will be amortized over its remaining useful life. No impairment losses were recorded on the IPR&D asset during the three and nine months ended September 30, 2022.

17

5. Property and Equipment, Net

Property and equipment, net consist of the following (in thousands):

  

Balance as of

 
  

September 30, 2022

  

December 31, 2021

 

Laboratory equipment

 $4,406  $4,406 

Leasehold improvements

  5,838   5,838 

Computer equipment and software

  1,589   1,589 

Construction in process

  9,481   13,805 

Tooling

  826   826 

Furniture and fixtures

  250   250 
   22,390   26,714 

Less accumulated depreciation and amortization

  (11,504

)

  (10,786

)

Property and equipment, net

 $10,886  $15,928 

The Company has decided to realign its cost structure from a focus on commercialization to a focus on advancing its recently acquired late-stage development pipeline, namely the pre-filled syringes and Niyad product candidates. As a result, the Company has also decided to not focus any development resources on Zalviso in the United States, and does not expect to resubmit the Zalviso NDA in the foreseeable future. In addition, due to the termination of the agreements with Grünenthal for Zalviso in Europe and the related withdrawal of the Marketing Authorization in Europe in July 2022, the Company does not expect any revenues from Zalviso in Europe in the foreseeable future. Accordingly, the Company determined that it is no longer probable that it will realize the future economic benefit associated with the costs of the Zalviso-related purchased equipment and manufacturing-related facility improvements the Company has made at its contract manufacturer and, therefore, recorded a non-cash impairment charge of $4.9 million to the Zalviso-related assets for the nine months ended September 30, 2022. The impairment charge was recorded as operating expense in the condensed consolidated statement of operations. Depreciation and amortization expense was $0.2 million and $0.7 million for the three and nine months ended September 30, 2022, respectively, and $0.3 million and $0.8 million for the three and nine months ended September 30, 2021, respectively.

6. Revenue from Contracts with Customers

The following table summarizes revenue from contracts with customers for the three and nine months ended September 30, 2022 and 2021, into categories that depict how the nature, amount, timing and uncertainty of revenue and cash flows are affected by economic factors (in thousands):

  

Three months ended
September 30, 2022

  

Nine months ended
September 30, 2022

 

Product sales:

        

DSUVIA

 $478  $1,364 

DZUVEO

  29   155 

Total product sales

 $507  $1,519 

  

Three months ended
September 30, 2021

  

Nine months ended
September 30, 2021

 

Product sales:

        

DSUVIA

 $160  $733 

Zalviso

     270 

Total product sales

  160   1,003 
         

Contract and collaboration revenue:

        

License revenue

  1,696   1,696 

Non-cash royalty revenue related to Royalty Monetization (Note 9)

     83 

Royalty revenue

     28 

Other revenue

  6   6 

Total revenues from contract and other collaboration

  1,702   1,813 

Total revenue

 $1,862  $2,816 

 

 

June 30, 2023

  

December 31, 2022

 

Accounts receivable, net

 $15  $309 

Inventories

     1,178 

Prepaid expenses and other current assets

  11   444 

Total current assets of discontinued operations

  26   1,931 

Property, plant and equipment, net

     10,261 

Operating lease right-of-use assets

     3,499 

Other assets

     176 

Total non-current assets of discontinued operations

    $13,936 

Total assets of discontinued operations

 $26   15,867 

 

 

 

  

 

 

Accounts payable

 $35  $784 

Accrued liabilities

  1,120   1,720 

Operating lease liabilities, current portion

     1,601 

Note payable, current portion

     400 

Deferred revenue, current portion

     115 

Total current liabilities of discontinued operations

  1,155   4,620 

Operating lease liabilities, net of current portion

     2,959 

Deferred revenue, net of current portion

     1,036 

Total non-current liabilities of discontinued operations

     3,995 

Total liabilities of discontinued operations

  1,155   8,615 

Net assets (liabilities) of discontinued operations

 $(1,129) $7,252 

 

1814

 

For additional details onThe following table presents the Company’s accounting policy regarding revenue recognition, refer to Note 1 “Organizationsignificant non-cash items and Summarypurchases of Significant Accounting Policies - Revenue from Contracts with Customers”property, plant and equipment for the discontinued operations that are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.accompanying unaudited condensed consolidated statements of cash flows (in thousands):

 

Product Sales

The Company’s commercial launch of DSUVIA in the United States occurred in the first quarter of 2019. Zalviso was sold in Europe by the Company’s collaboration partner, Grünenthal, through May 12, 2021, at which time, due to the termination of the Grünenthal Agreements, the rights to market and sell Zalviso in Europe reverted back to the Company. In July 2022, the European Marketing Authorization for Zalviso was withdrawn. DZUVEO sales in Europe by the Company’s collaboration partner, Aguettant, have recently commenced.

Contract and Other Collaboration

Contract and other collaboration revenue includes revenue under the Grünenthal Agreements related to research and development services, non-cash royalty revenue related to the Royalty Monetization and royalty revenue for sales of Zalviso in Europe and license revenue recognized under the DZUVEO Agreement. For the three and nine months ended September 30, 2022, the Company did not record any contract and other collaboration revenue.

Contract Liabilities

A contract liability of $1.2 million was recorded on the condensed consolidated balance sheets as deferred revenue as of September 30, 2022, $0.1 million of which represented the current portion, for the portion of the upfront fee received under the DZUVEO Agreement allocated to the material right for discounted price on future optional product supply which has not yet been satisfied. The material right contract liability will be recognized over the period the discount on future product supply is made available.

 

 

Six months ended

 

 

 

June 30,

 

 

 

2023

  

2022

 

Cash flows from operating activities:

        

Depreciation and amortization

 $215  $795 

Stock-based compensation

  19   183 

Impairment of net assets held for sale

  6,935    

Impairment of fixed assets

  1,065    

Gain on termination of lease liabilities

  (1,098)   

Gain on extinguishment of debt

  (400)   

 

The following table presents changes inrepresents the Company’s contract liabilitygain (loss) on sale of discontinued operations for the ninethree and six months ended SeptemberJune 30, 2022 2023:and 2021 (in thousands):

 

Balance at January 1, 2022

 $1,237 

Deductions for performance obligations satisfied:

    

In current period

  (43)

Balance at September 30, 2022

 $1,194 

Balance at January 1, 2021

 $49 

Additions(1)

  1,237 

Deductions for performance obligations satisfied:

    

In current period

  (49)

Balance at September 30, 2021

 $1,237 

(1) Deferred revenue under the DZUVEO Agreement with Aguettant.

  

Three Months Ended

June 30, 2023

  

Six Months Ended

June 30, 2023

 

Cash proceeds

 $2,723  $2,723 

Less: net assets transferred

  117   (8,723)

Less: disposal costs

  (45)  (935)

Loss on sale of discontinued operations, before income taxes

  2,795   (6,935)

Income tax expense

      

Gain (loss) on sale of discontinued operations

 $2,795  $(6,935)

 

 

7.4. In-License Agreement

On July 14, 2021, the Company entered into a License and Commercialization Agreement, or the PFS Agreement, with Aguettant pursuant to which the Company obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection. Aguettant will supply the Company with the products for use in commercialization, if they are approved in the United States.

The PFS Agreement has an initial term of ten (10) marketing years, with the first marketing year ending on December 31 of the calendar year after the first launch of a product (or December 31 of the same calendar year if the first launch of a product occurs between January 1 and April 30 of a calendar year). The term will automatically renew for successive five marketing year periods unless a party notifies the other party of its intention not to renew at least six (6) months prior to the expiration of the then-current term.

The Company will purchase each product from Aguettant at an agreed price, or the PFS Purchase Price, subject to adjustment. The Company will also make revenue share payments that, combined with the PFS Purchase Price, will range from 40% to 45% of net sales in the United States.

The Company and Aguettant will agree on minimum sales obligations twelve (12) months prior to the launch of each product.

The Company has the right to grant sublicenses to its affiliates or, with the prior approval of Aguettant, third parties, subject to certain limitations.

In connection with AcelRx’s and Aguettant’s agreement to enter into the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement, the parties entered into an amendment to the PFS Agreement, or the Amended PFS Agreement, pursuant to which, effective April 3, 2023, (a) Aguettant paid AcelRx a complementary payment in the amount of EUR 1,500,000, and (b) AcelRx’s obligation to make a certain specified sales-milestone payment terminated such that the maximum amount in sales-based milestone payments that Aguettant is entitled to receive has been reduced from $24 million to $21 million.

As of June 30, 2023, there have been no payments by the Company to Aguettant under the PFS Agreement.

15

5. Long-Term Debt

 

Loan Agreement with Oxford

 

On May 30, 2019, the Company entered into the Loan Agreement with Oxford.Oxford Finance LLC, or Oxford, as the Lender. Under the Loan Agreement, the Lender made a term loan to the Company in an aggregate principal amount of $25.0 million, or the Loan, which was funded on May 30, 2019.The Loan Agreement requires that the Company always maintain unrestricted cash of not less than $5.0 million in accounts subject to control agreements in favor of the Lender, tested monthly as of the last day of the month.

 

In connection with the Loan Agreement, on May 30, 2019, the Company issued warrants to the Lender and its affiliates, or the Warrants, which are exercisable for an aggregate of 8,833 shares of the Company’s common stock with a per share exercise price of $56.60. The Warrants have been classified within stockholders’ deficit and accounted for as a discount to the loan by allocating the gross proceeds on a relative fair value basis.

19

As of SeptemberJune 30, 20222023 and December 31, 2021,2022, the accrued balance due under the Loan Agreement with Oxford was $7.4 million$0 and $13.3$5.4 million, respectively. Interest expense related to the Loan Agreement was $0.2immaterial for the three months ended June 30, 2023, and $0.1 million, $0.1 million of which represented amortization of the debt discount, for the six months ended June 30, 2023. Interest expense related to the Loan Agreement was $0.3 million, $0.1 million of which represented amortization of the debt discount, and $0.9$0.7 million, $0.3$0.2 million of which represented amortization of the debt discount, for the three and ninesix months ended SeptemberJune 30, 2022,respectively, while such interest expense was $0.5 million, $0.1 million of which represented amortization of the debt discount, and $1.7 million, $0.5 million of which represented amortization of the debt discount for the three and nine months ended September 30, 2021, respectively.

 

Non-Interest Bearing Payments forIn connection with the Constructionclosing of Leasehold Improvements

Inthe divestment of DSUVIA to Alora, the Company and Oxford agreed that the Company would repay the loan in full without any prepayment penalties or the payment of future remaining interest that otherwise would have been payable under the Loan. On August 2019,April 3, 2023, the Company entered into a Site Readiness Agreement, or SRA, with Catalent Pharma Solutions, LLC, or Catalent, in contemplationpaid Oxford the remaining amount due of entering into a commercial supply agreement for its product DSUVIA at a future date. Under the SRA, the Company is building out a suite within Catalent’s production facility in Kansas City. If additional equipmentapproximately $3.4 million including accrued interest and facility modifications are required to meet the Company’s product needs, the Company may be required to contribute to the cost of such additional equipment and facility modifications. The Company has determined that it is the owner of the leasehold improvements related to the build-out which are being paid in four annual installments of $0.5 million each. As of September 30, 2022 and December 31, 2021, the accrued balancefees under the SRALoan, and the Loan Agreement was $0.5 million, and $1.7 million of these leasehold improvements had been capitalized. The effective interest rate related to the payments atterminated with September 30, 2022 nowas 14%. The leasehold improvements are recorded as property and equipment, net, in the condensed consolidated balance sheets. further obligations by either party.

 

 

8. Leases

Office Lease

On March 26, 2021, the Company entered into a Sublease Agreement to sublet space for its new corporate headquarters. The Sublease Agreement commencement date was April 1, 2021. The Sublease Agreement is for a period of two years and three months with monthly rental payments of $17,000, including one month of abated rent. On the lease commencement date, the Company recognized an operating lease right-of-use asset in the amount of $0.4 million.

Contract Manufacturing Leases

The Company has entered into commercial supply manufacturing services agreements related to Zalviso and DSUVIA containing fixed fees which it has determined are in-substance lease payments. For additional information on these agreements, refer to Note 9 “Leases” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021.

The components of lease expense are presented in the following table (in thousands):

  

Three Months Ended
September 30,

  

Nine Months Ended
September 30,

 
  

2022

  

2021

  

2022

  

2021

 

Operating lease costs

 $344  $343  $1,030  $1,123 

Gain on derecognition of operating lease

           (522

)

Sublease income

           (199

)

Loss on termination of sublease

           331 

Net lease costs

 $344  $343  $1,030  $733 

The weighted average remaining lease term and discount rate related to the operating leases are presented in the following table:

  

September 30, 2022

  

September 30, 2021

 

Weighted-average remaining lease term – operating leases (in years)

  4.36   5.21 

Weighted-average remaining discount rate – operating leases

  12.8

%

  12.8

%

Maturities of lease liabilities as of September 30, 2022 are presented in the following table (in thousands):

Year:

    

2022 (remaining three months)

 $835 

2023

  1,344 

2024

  1,090 

2025

  1,040 

2026

  1,040 

Thereafter

  415 

Total future minimum lease payments

  5,764 

Less imputed interest

  (1,176)

Total

 $4,588 

20

Reported as:

Operating lease liabilities

 $4,588 

Operating lease liabilities, current portion

  (1,360)

Operating lease liabilities, net of current portion

 $3,228 

9. Liability Related to Sale of Future Royalties

On September 18, 2015, the Company entered into the Royalty Monetization with PDL for which it received gross proceeds of $65.0 million. Under the Royalty Monetization, PDL was to receive 75% of the European royalties under the Amended License Agreement with Grünenthal, as well as 80% of the firstfour commercial milestones worth $35.6 million (or 80% of $44.5 million), up to a capped amount of $195.0 million over the life of the arrangement.

The Company periodically assessed the expected royalty and milestone payments using a combination of historical results, internal projections and forecasts from external sources. To the extent such payments were greater or less than the Company’s initial estimates or the timing of such payments is materially different than its original estimates, the Company prospectively adjusted the amortization of the liability and the effective interest rate. Grünenthal notified the Company that it was terminating the Amended License Agreement effective November 13, 2020. On August 31, 2020, PDL sold its royalty interest for Zalviso to SWK Funding, LLC, or SWK, under the Royalty Monetization. The terms of the Grünenthal Agreements were extended to May 12, 2021 to enable Grünenthal to sell down its Zalviso inventory. The rights to market and sell Zalviso in the Zalviso Territory reverted back to the Company on May 12, 2021.

On May 31, 2022, the Company entered into a Termination Agreement with SWK to fully terminate the Royalty Monetization for which the Company paid cash consideration of $0.1 million, and neither PDL nor SWK retains any further interest in the Royalty Monetization. Accordingly, effective May 31, 2022, the Royalty Monetization is no longer reflected on the Company’s consolidated financial statements or other records as a sale of assets to PDL or SWK and all security interests and other liens of every type held by the parties to the Royalty Monetization have been terminated and automatically released without further action by any party. The $84.1 million gain on extinguishment of the liability related to the sale of future royalties is recognized in the condensed consolidated statements of operations as other income.

The effective interest income rate for nine-month period ended September 30, 2022, was approximately 3.2%. The effective interest income rate for the nine-month period ended September 30, 2021, was approximately 3.6%.

The following table shows the activity within the liability account related to the sale of future royalties for the nine months ended September 30, 2022 and the period from inception on September 18, 2015 to September 30, 2022 (in thousands):

  

Nine months

ended
September 30, 2022

  

Period from
inception to
September 30, 2022

 

Liability related to sale of future royalties — beginning balance

 $85,288  $ 

Proceeds from sale of future royalties

     61,184 

Non-cash royalty revenue

     (1,083

)

Non-cash interest (income) expense recognized

  (1,136

)

  24,051 

Consideration paid for termination of Royalty Monetization

  (100

)

  (100)

Gain on termination of liability related to sale of future royalties

  (84,052

)

  (84,052

)

Liability related to sale of future royalties as of September 30, 2022

 $  $ 

As mentioned above, the Royalty Monetization was terminated on May 31, 2022.

10.6. Commitments and Contingencies

 

Litigation

 

On June 8, 2021, a securities class action complaint was filed in the U.S. District Court for the Northern District of California against the Company and two of its officers. The plaintiff is a purported stockholder of the Company. The complaint allegesalleged that defendants violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by making false and misleading statements and omissions of material fact about the Company’s disclosure controls and procedures with respect to its marketing of DSUVIA. The complaint seekssought unspecified damages, interest, attorneys’ fees, and other costs. On December 16, 2021, the Court appointed co-lead plaintiffs. Plaintiffs’ amended complaint was filed on March 7, 2022. The amended complaint namesnamed the Company and three of its officers and continuescontinued to allege that defendants violated Sections 10(b) and 20(a) of the Exchange Act and SEC Rule 10b-5 by making false and misleading statements and omissions of material fact about the Company’s disclosure controls and procedures with respect to its marketing of DSUVIA. The amended complaint also allegesasserted a violation of Section 20A of the Exchange Act against the individual defendants for alleged insider trading. The amended complaint sought unspecified damages, interest, attorneys’ fees, and other costs. On September 1, 2022, the Court held oral hearings on the Company’s motion to dismiss the amended complaint with prejudice that was filed on July 21, 2022. On September 28, 2022, the Court issued a formal written opinion, or the First Opinion, dismissing all of the plaintiff’s claims against the Company and the named defendants. Plaintiffs have been granteddefendants with leave for plaintiffs to amend their complaint. On 60November 28, 2022 the plaintiffs filed their second daysamended complaint. On July 7, 2023, the Court issued a formal written opinion, or the Second Opinion, dismissing all of the plaintiff’s claims against the Company and the named defendants with leave for plaintiffs to amend their complaint in part and resubmit on or beforewithout leave to amend in part. The plaintiff’s deadline to file a November 28, 2022.third amended complaint is September 5, 2023.

 

21

On July 6, 2021, a purported shareholder derivative complaint was filed in the U.S. District Court for the Northern District of California. The complaint names ten of the Company’s officers and directors and asserts state and federal claims based on the same alleged misstatements as the shareholdersecurities class action complaint. On September 30, 2021, October 26, 2021, and November 17, 2021, three additional purported shareholder derivative complaints were filed in the U.S. District Court for the Northern District of California. The complaints name nine of the Company’s officers and directors and also assert state and federal claims based on the same alleged misstatements as the shareholdersecurities class action complaint. All four complaints seek unspecified damages, attorneys’ fees, and other costs. On December 6, 2021, the Court entered an order consolidating all four actions and staying the consolidated action pending the outcome of any motion to dismiss the securities class action. Please see “Part II., Item 1A. Risk Factors—Risks of a General Nature—Litigation may substantially increase our costs and harm our business.business.

 

The Company believes that these lawsuits are without merit and intends to vigorously defend against them. Given the uncertainty of litigation, the preliminary stage of the cases, and the legal standards that must be met for, among other things, class certification and success on the merits, the Company cannot estimate the reasonably possible loss or range of loss that may result from these actions.

 

11. Stockholders Equity

Preferred Stock

On August 3, 2022, the Company entered into a securities purchase agreement with Lincoln Park Capital Fund, LLC, or LPC or the Purchaser, pursuant to which the Company issued, in a private placement transaction, 3,000 shares of Series A Redeemable Convertible Preferred Stock, par value $0.001 per share, with $100 per share stated value, together with a warrant to purchase up to an aggregate of 81,150 shares of common stock at an exercise price of $4.07 per share (see Note 12 “Warrants”), for $0.3 million. The transaction price of $0.3 million was allocated to the Series A Redeemable Convertible Preferred Stock and warrants based on their relative fair values. The Series A Redeemable Convertible Preferred Stock was initially recorded at $0.1 million separately from stockholders’ equity in the Company’s condensed consolidated balance sheets due to the shares being redeemable based on based on contingent events outside of the Company’s control.

The Series A Redeemable Convertible Preferred Stock was convertible, at the option of the holders, into shares of common stock at a conversion price of approximately $3.70 per share, subject to adjustment and beneficial ownership limitations set forth in the Certificate of Designation. The Company had the option to redeem the Series A Redeemable Convertible Preferred Stock for cash at 105% of the Stated Value on the date of and for 15 days following the Reverse Stock Split, subject to the Purchaser’s right to convert the shares prior to such redemption. The Purchaser has the right to require the Company to redeem the shares of Series A Redeemable Convertible Preferred Stock for cash at 110% of the Stated Value of such shares commencing after the Company’s right to redeem expires. The Series A Redeemable Convertible Preferred Stock must be redeemed for cash at 110% of the Stated Value upon a delisting event. As a result, the Series A Redeemable Convertible Preferred Stock was recorded separately from stockholders’ equity because it was redeemable upon the occurrence of redemption events that were considered not solely withing the Company’s control. As such, during the three months ended September 30, 2022, the Company recognized approximately $0.2 million in deemed dividends related to the Series A Redeemable Convertible Preferred Stock in the condensed consolidated statements of operations and comprehensive loss and the condensed consolidated statements of changes in redeemable convertible preferred stock and stockholders’ equity (deficit).

As of September 30, 2022 the Company’s intent was to redeem the Series A Redeemable Convertible Preferred Stock at its election therefore, the Series A Redeemable Convertible Preferred Stock was remeasured to the expected redemption value of $0.3 million, with a “deemed dividend” of $0.2 million recorded and impacts earnings per share.

The holders of the Series A Redeemable Convertible Preferred Stock was entitled to certain registration rights, rights for approval of increases in the authorized shares of such series, and to dividends paid on common stock on an as-if converted basis. The Series A Redeemable Convertible Preferred stock had no voting rights, other than the right to (i) vote exclusively on the Reverse Stock Split and any proposal to adjourn any meeting of stockholders called for the purpose of voting on the Reverse Stock Split and (ii) to 1,000,000 votes per each share of Series A Redeemable Convertible Preferred Stock, to vote together with the common stock, as a single class; to the extent cast on the Reverse Stock Split in the same proportion as shares of common stock. In addition, in the event of any liquidation, dissolution, or winding-up of the Company, the holders of the Series A Redeemable Convertible Preferred Stock are entitled to receive 110% the preferred stock’s Stated Value plus any declared but unpaid dividends before any payment is made to holders of common stock.

2216

 

On October 11, 2022, the CompanyTermination Agreement and LPC entered into the Securities Redemption Agreement whereby on October 12, 2022, the Company redeemed for cash at a price equal to 105% of the Stated Value per share all 3,000 outstanding shares of Series A Redeemable Convertible Preferred Stock for $0.3 million. As a result, all shares of such series were retiredMutual Release Between AcelRx and are no longer outstanding. On October 25, 2022, the Company filed a certificate of elimination to its amended and restated certificate of incorporation which (i) eliminated the previous designation of 3,000 shares of Series A Redeemable Convertible Preferred Stock from the Company’s amended and restated certificate of incorporation and (ii) caused such shares of Series A Redeemable Convertible Preferred Stock to resume their status as authorized but unissued and non-designated shares of preferred stock.

Common StockCatalent

 

ATM Agreement

The Company hasOn March 12, 2023, AcelRx and Catalent Pharma Solutions, LCC, or Catalent, entered into a termination agreement and mutual release, or the ATMTermination Agreement, to terminate the Site Readiness Agreement with Cantor,an effective date of August 15, 2019 and as agent, pursuantamended on September 24, 2020, the SRA Agreement, and the commercial supply agreement with an effective date of March 31, 2021, the CSA Agreement. Pursuant to which the Company may offer and sell, from time to time through Cantor, sharesTermination Agreement, as of the Company’s common stock having an aggregate offering price of up to $80.0 million.

The Company issueddate on which AcelRx has removed and sold approximately 0.04 million shares of common stock pursuant totransported certain equipment from Catalent’s site, the ATMSRA Agreement and received net proceedsthe CSA Agreement will terminate except with respect to certain specified provisions of $0.2 million, after deducting fees and expenses, during the three and nine months ended September 30, 2022. During the nine months ended September 30, 2021, the Company issued and sold approximately 0.2 million shares of common stock pursuant to the ATM Agreement, and received net proceeds of approximately $7.5 million, after deducting fees and expenses. As of September 30, 2022, the Company may offer and sell shares of the Company’s common stock having an aggregate offering price of up to $35.9 million under the ATM Agreement.such agreements.

 

 

12.7. Warrants

 

The activity related to warrants during the August 2022sixLPC Warrant months ended June 30, 2023, is summarized as follows:

 

  

Common
Stock from

Warrants

  

Weighted-
average
Exercise
Price
(per share)

 

Outstanding at December 31, 2022

  7,824,933  $1.72 

Pre-funded warrants exercised

  2,632,898  $0.0001 

Outstanding at June 30, 2023

  5,192,035  $2.59 

Exercisable at June 30, 2023

  5,192,035  $2.59 

On

The pre-funded warrants issued in August 3,December 2022 the Company entered into a securities purchase agreement with LPC pursuant to which the Company, in a private placement transaction, sold (i) an aggregate of 3,000 shares of the Company's Series A Redeemable Convertible Preferred Stock, and (ii) warrants to purchase up to an aggregate of 81,1502,632,898 shares of common stock, foror the 2022 Pre-Funded Warrants, were exercised in full in the three months ended March 31, 2023. The common warrants issued in December 2022 to purchase an aggregate purchase price of $0.3 million (see Note4,227,052 shares of common stock, or the 112022 “Stockholders’ Equity”).

TheWarrants, were accounted for by the Company as a liability. At August June 30, 2023, the 2022LPC Warrant has an exercise price of $4.07 per share (subject to adjustment for stock splits, reverse stock splits and similar recapitalization events) and became immediately exercisable and has a term ending on February 3, 2028. 

The August 2022 LPC Warrant was Warrants were valued at approximately $0.3$3.1 million, using the Black-Scholes option pricing model as follows: exercise price of $4.07$2.07 per share, stock price of $4.44$1.11 per share, expected life of 5.5 years, volatility of 89.94%91.49%, a risk-free rate of 2.86%4.13% and 0% expected dividend yield. The Series A Redeemable Convertible Preferred StockSee Note 2, “Investments and Fair Value Measurement” above. On April 25, 2023, the August 2022LPC Warrant Warrants were issued in a unit structure withamended to remove the August 2022 LPC Warrant eligible to be classified in stockholders’ equity, therefore the aggregate net proceeds of $0.2 million were allocated to the two securities using the relative fair value method, resultingfull ratchet anti-dilutive adjustment rights in the Series A Redeemable Convertible Preferred Stock and the August 2022 LPC Warrant being allocated values of $129,000 and $110,000, respectively, and recorded to stockholders' equity.

As of September 30, 2022, the August 2022 LPC Warrant had not been exercised and was still outstanding.

November 2021Financing Warrants

On November 15, 2021, event the Company entered into a securities purchase agreement with certain investors pursuant to which the Company, in a registered direct offering, sold (i) an aggregate of 875,000 shares of the Company's common stock, and (ii) warrants to purchase up to an aggregate of 875,000issues shares of common stock for an aggregate purchaseor common stock equivalents in the future with a value less than the then effective exercise price of $14.0 million.

such common warrants subject to certain customary exceptions, and further subject to a minimum exercise price of $1.00 per share. The2022 Warrants and the financing warrants issued in November 2021 Financing Warrants have an exercise priceare participating securities which, by definition, entitle the holders thereof to participate in dividends and other distributions of $20.00 per share and become exercisable, if the holder’s post-exercise beneficial ownership is less than or equal to 9.99%, 6 months after their issuance date and have a five-year term ( November 15, 2026). All common stock issuable under the issued warrants, were added to the Company’s effective registration statement on November 15, 2021.

The November 2021 Financing warrants were valued at approximately $8.6 million using the Black-Scholes option pricing model as follows: exercise price of $20.00 per share, stock price of $14.92 per share, expected life of five years, volatility of 91.77%, a risk-free rate of 1.26% and 0% expected dividend yield. The common stock and warrants were issued in a unit structure; therefore, in accordance with ASC Topic 815, the aggregate gross proceeds of $14.0 million were allocated to the two securities using the relative fair value method, resulting in the common stock and warrants being allocated values of $8.4 million and $5.6 million, respectively, and recorded to stockholders' equity.

As of September 30, 2022, the November 2021 Financing Warrants had not been exercised and were still outstanding.

23

Loan Agreement Warrants

In connection with the Loan Agreement, on May 30, 2019, assets by the Company issued warrants to the Lender and its affiliates, which are exercisable for an aggregate of 8,833 shares of the Company’s common stock with a per share exercise price of $56.60, or the Loan Agreement Warrants. The Loan Agreement Warrants may be exercised on a cashless basis. The Loan Agreement Warrants are exercisable for a term beginning on the date of issuance and ending on the earlier to occur of ten years from the date of issuance or the consummation of certain acquisitions of the Company as set forth in the Loan Agreement Warrants. The number of shares for which the Loan Agreement Warrants are exercisable and the associated exercise price are subject to certain proportional adjustments as set forth in the Loan Agreement Warrants.

The Company estimated the fair value of these Loan Agreement Warrants as of the issuance date to be $0.4 million, which was used in estimating the fair value of the debt instrument and was recorded as equity. The fair value of the Loan Agreement Warrants was calculated using the Black-Scholes option-valuation model, and was based on the strike price of $56.60, the stock price at issuance of $53.20, the ten-year contractual term of the warrants, a risk-free interest rate of 2.22%, expected volatility of 80.22% and 0% expected dividend yield.

As of September 30, 2022, Loan Agreement Warrants to purchase 8,833 sharesholders of common stock issued toshares as though the Lender and its affiliates had not been exercised and were still outstanding. These warrants expire in May 2029.holder then held common shares. 

 

 

13.8. Stock-Based Compensation

 

The Company recorded total stock-based compensation expense for stock options, restricted stock units, or RSUs, and the Amended and Restated 2011 Employee Stock Purchase Plan, or the Amended ESPP, as follows (in thousands):

 

 

Three Months Ended
September 30,

  

Nine Months Ended
September 30,

  

Three Months Ended
June 30,

  

Six Months Ended
June 30,

 
 

2022

 

2021

 

2022

  

2021

  

2023

  

2022

  

2023

  

2022

 

Cost of goods sold

 $13  $24  $48  $67 

Research and development

 139  216  466  597  $80  $153  $173  $327 

Selling, general and administrative

  549   981   1,723   2,818   391   562   848   1,026 

Discontinued operations

     38   19   183 

Total

 $701  $1,221  $2,237  $3,482  $471  $753  $1,040  $1,536 

 

17

The following table summarizes restricted stock unit activity under the Company’s equity incentive plans:

 

     

Weighted

      

Weighted

 
 

Number of

 

Average

  

Number of

 

Average

 
 

Restricted

 

Grant Date

  

Restricted

 

Grant Date

 
 

Stock Units

  

Fair Value

  

Stock Units

  

Fair Value

 

Restricted stock units outstanding, January 1, 2022

 88,718  $34.20 

Restricted stock units outstanding, January 1, 2023

 82,778  $16.97 

Granted

 58,516  7.80  44,091  1.76 

Vested

 (44,232) 35.60  (34,606) 21.61 

Forfeited

  (16,324) 25.40   (2,926) 13.91 

Restricted stock units outstanding, September 30, 2022

  86,678  $17.20 

Restricted stock units outstanding, June 30, 2023

  89,337  $7.77 

 

Upon vesting, certain of the Company’s RSUs may be settled on a net-exercise basis to cover any required withholding tax with the remaining amount converted into an equivalent number of shares of common stock. There were 0 and 7,09812,906 shares of common stock underlying vested RSUs that were withheld during the three and nine monthsquarter ended September 30, 2022,March 31, 2023, respectively, based on the value of the RSUs as determined by the Company’s closing stock price on the applicable vesting date.

 

24

The following table summarizes stock option activity under the Company’s equity incentive plans:

 

 

Number
of Stock Options
Outstanding

 

Weighted-
Average
Exercise
Price

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

Aggregate
Intrinsic
Value

  

Number
of Stock Options
Outstanding

 

Weighted-
Average
Exercise
Price

 

Weighted-
Average
Remaining
Contractual
Life (Years)

 

Aggregate
Intrinsic
Value

 
             

(in thousands)

              

(in thousands)

 

January 1, 2022

 714,202  $59.80      

January 1, 2023

 725,623  $52.98      

Granted

 117,032  7.80       264,520  1.76      

Forfeited

 (29,034) 27.20       (9,003) 12.09      

Expired

 (68,892) 60.80       (95,357) 81.71      

Exercised

                    

September 30, 2022

  733,308  $52.60  5.8  $ 
 

Vested and exercisable options—September 30, 2022

 505,825  $66.40  4.5  $ 

Vested and expected to vest—September 30, 2022

 733,308  $52.60  5.8  $ 

June 30, 2023

  885,783  $35.01   6.7  $ 

Vested and exercisable options— June 30, 2023

 466,502  $57.63  4.5  $ 

Vested and expected to vest— June 30, 2023

 885,783  $35.01  6.7  $ 

 

The per-share weighted average grant date fair value of the options granted forduring the ninesix months ended SeptemberJune 30, 20222023 was estimated at $5.80$1.39 per share on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions:

 

  

Nine months ended

September 30, 2022

 

Expected term (in years)

   6.3  

Risk-free interest rate

  1.6%-3.0% 

Expected volatility

   88%  

Expected dividend rate

   0%  

Six months ended

June 30, 2023

Expected term (in years)

6.3

Risk-free interest rate

3.9%

Expected volatility

94%

Expected dividend rate

0%

 

As of SeptemberJune 30, 2022,2023, total stock-based compensation expense related to unvested options to be recognized in future periods was $1.3 million which is expected to be recognized over a weighted-average period of 2.2 years. As of June 30, 2023, there were 331,649141,502 shares available for grant under the Company’s equity incentive plans and 211,876185,860 shares available for grant under the Amended ESPP.

 

 

14.9. Net Income (Loss) per Share of Common Stock

 

The Company’sCompany applies the two-class method to compute basic net income (loss) per share of common stock is calculated by dividing the net income (loss) allocableattributable to common shareholders by the weighted average number of shares of common stock outstanding for the period. The diluted net income (loss) per share of common stock is computed by giving effect to all potential common stock equivalents outstanding for the period determined using the more dilutive of the 1) treasury stock method, if-converted method, or contingently issuable share method, as applicable, or 2) the two-class method. For purposes of this calculation, options to purchase common stock, RSUs, and warrants to purchase common stock were considered to be common stock equivalents.

During the three and six months ended June 30, 2022, the Company presents diluted EPS using the two-class method as it was more dilutive. The Company’s participating securities do not have a contractual obligation to share in the Company’s losses, therefore, net loss for the three and six months ended June 30, 2023 was attributed entirely to common stockholders. In periods with a reported net loss, common stock equivalents are excluded from the calculation of diluted net loss per share of common stock if their effect is antidilutive. Potential common shares that are issuable for little or no cash consideration, such as the Company’s pre-funded warrants issued in December 2022 with a de minimis exercise price of $0.0001 per share, are considered outstanding common shares which are included in the calculation of basic and diluted net income (loss) per share in all circumstances.

 

2518

 

The following table sets forth the computation of the Company’s basic and diluted net income (loss) per share of common stock during the three and ninesix months ended SeptemberJune 30, 20222023 and 20212022 (in thousands, except for share and per share amounts):

 

  

Three Months Ended September 30,

  

Nine Months Ended September 30,

 
  

2022

  

2021

  

2022

  

2021

 
  

(in thousands, except share and per share amounts)

 

Basic net income (loss) per common share:

                

Net (loss) income

 $(6,750) $(8,375) $55,239  $(27,182)

Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock

  (186)     (186)   

Less: income allocated to participating securities

        (129)   

Net (loss) income attributable to common shareholders

  (6,936)  (8,375)  54,924   (27,182)

Weighted average shares outstanding — basic

  7,377,363   5,961,224   7,338,853   5,861,111 

Net income (loss) per share — basic

 $(0.94) $(1.40

)

 $7.48  $(4.64

)

                 

Diluted net income (loss) per common share:

                

Net (loss) income

 $(6,750) $(8,375) $55,239  $(27,182)

Less: deemed dividend related to Series A Redeemable Convertible Preferred Stock

  (186)     (186)   

Less: income allocated to participating securities

        (129)   

Net (loss) income attributable to common shareholders

  (6,936)  (8,375)  54,924   (27,182)

Weighted average shares outstanding — basic

  7,377,363   5,961,224   7,338,853   5,861,111 

Dilutive effect of RSUs

        1,345    

Dilutive effect of Warrants

        27,095    

Weighted average shares outstanding — diluted

  7,377,363   5,961,224   7,367,293   5,861,111 

Net income (loss) per share — diluted

 $(0.94) $(1.40

)

 $7.46  $(4.64

)

 

  

Three Months Ended June 30,

 
  

2023

  

2022

 
         
  

(in thousands, except share and per share amounts)

 

Basic net income (loss) per common share:

        

Net income (loss) from continuing operations

 $(4,428

)

 $74,315 

Less: income allocated to participating securities

     (7,511

)

Net income (loss) from continuing operations attributable to common shareholders, basic

  (4,428

)

  66,804 

Net income (loss) from discontinued operations attributable to common shareholders, basic

  57   (3,652

)

Net income (loss) attributable to common shareholders, basic

 $(4,371

)

 $63,152 

Weighted average shares outstanding — basic

  10,924,294   7,356,952 

Income (loss) from continuing operations, basic

 $(0.41

)

 $9.08 

Income (loss) from discontinued operations, basic

 $0.01  $(0.50

)

Net income (loss) per share, basic

 $(0.40

)

 $8.58 

Diluted net income (loss) per common share:

        

Net income (loss) from continuing operations

 $(4,428

)

 $74,315 

Less: income allocated to participating securities

     (7,508

)

Net income (loss) from continuing operations attributable to common shareholders, diluted

  (4,428

)

  66,807 

Net income (loss) from discontinued operations attributable to common shareholders, diluted

  57   (3,652

)

Net income (loss) attributable to common shareholders, diluted

 $(4,371

)

  63,155 

Weighted average shares outstanding — basic

  10,924,294   7,356,952 

Dilutive effect of RSUs

     3,501 

Weighted average shares outstanding — diluted

  10,924,294   7,360,453 

Income (loss) from continuing operations, diluted

 $(0.41

)

 $9.08 

Income (loss) from discontinued operations, diluted

 $0.01  $(0.50

)

Net income (loss) per share, diluted

 $(0.40

)

 $8.58 

  

Six Months ended June 30,

 
  

2023

  

2022

 
         
  

(in thousands, except share and per share amounts)

 

Basic net income (loss) per common share:

        

Net income (loss) from continuing operations

 $(4,364

)

 $69,700 

Less: income allocated to participating securities

     (6,619

)

Net income (loss) from continuing operations attributable to common shareholders, basic

  (4,364

)

  63,081 

Net income (loss) from discontinued operations attributable to common shareholders, basic

  (8,159

)

  (7,711

)

Net income (loss) attributable to common shareholders, basic

 $(12,523

)

 $55,370 

Weighted average shares outstanding — basic

  10,909,208   7,319,279 

Income (loss) from continuing operations, basic

 $(0.40

)

 $8.62 

Income (loss) from discontinued operations, basic

 $(0.75

)

 $(1.06

)

Net income (loss) per share, basic

 $(1.15

)

 $7.56 

Diluted net income (loss) per common share:

        

Net income (loss) from continuing operations

 $(4,364

)

 $69,700 

Less: income allocated to participating securities

     (6,618

)

Net income (loss) from continuing operations attributable to common shareholders, diluted

  (4,364

)

 $63,082 

Net income (loss) from continuing operations attributable to common shareholders, diluted

  (8,159

)

 $(7,711

)

Net income (loss) from continuing operations attributable to common shareholders, diluted

 $(12,523

)

 $55,371 

Weighted average shares outstanding — basic

  10,909,208   7,319,279 

Dilutive effect of RSUs

     1,743 

Weighted average shares outstanding — diluted

  10,909,208   7,321,022 

Income (loss) from continuing operations, diluted

 $(0.40

)

 $8.62 

Income (loss) from discontinued operations, diluted

 $(0.75

)

 $(1.06

)

Net income (loss) per share, diluted

 $(1.15

)

 $7.56 

19

The following outstanding shares of common stock equivalents were excluded from the computation of diluted net income (loss) per share of common stock for the periods presented because including them would have been antidilutive:

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

  

Three Months Ended

June 30,

  

Six Months Ended

June 30,

 
 

2022

 

2021

 

2022

 

2021

  

2023

  

2022

  

2023

  

2022

 

RSUs, stock options and ESPP to purchase common stock

 821,875  823,766  817,086  823,766  975,120  826,010  975,120  823,172 

Common stock warrants

 964,983  8,833  910,928  8,833  5,192,035  883,833  5,192,035  883,833 

10. Subsequent Events

 

In addition, Securities Purchase Agreement

On July 17, 2023, the Company entered into a securities purchase agreement, or the Purchase Agreement, with several institutional investors, or the Purchasers, relating to the issuance and sale to the Purchasers in a private placement of 5,340,591 shares held backof common stock, par value $0.001 per share, pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of common stock at an exercise price of $0.001 per share; Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share; and contingently issuable in connection withSeries B common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share.

The pre-funded warrants are exercisable immediately following the Lowell Merger,closing date of the private placement and have an unlimited term and an exercise price of $0.001 per share.

The Series A and Series B common stock warrants will be exercisable immediately following the closing date of the private placement and have a five-year term and an exercise price of $1.11 per share. The Series A and Series B common stock warrants also include certain rights upon “fundamental transactions” as described in Note 4. above, have also been excludedsuch warrants, including the right of the holders thereof to receive from AcelRx or a successor entity the computationsame type or form of diluted net income (loss)consideration (and in the same proportion) that is being offered and paid to the holders of common stock in such fundamental transaction in the amount of the Black Scholes value (as described in such warrants) of the unexercised portion of the applicable warrants on the date of the consummation of such fundamental transaction.

The combined offering price is $1.36 per share of common stock for the periods presented because the contingencies for issuance of these shares have not been met. Further, theand accompanying Series A Redeemable Convertible preferred shares contingently convertible to common shares upon certain events, as describedstock warrant and Series B common stock warrant, or in Note 11 above, have been excluded from the computationcase of diluted net income (loss)pre-funded warrants, $1.359 per pre-funded warrant and accompanying Series A common stock warrant and Series B common stock warrant (which is the purchase price per share of common stock and accompanying warrants less $0.001). The aggregate gross proceeds to AcelRx from the private placement are expected to be approximately $10.0 million, before deducting placement agent fees and other estimated expenses payable by AcelRx, and excluding the proceeds, if any, from the exercise of the pre-funded warrants and Series A and Series B common stock warrants issued in the private placement. The potential gross proceeds from the Series A common stock warrants and Series B common stock warrants, if fully exercised for cash, is approximately $16.3 million.

In May 2023, AcelRx engaged H.C. Wainwright & Co., LLC to act as placement agent in the three months ended September 30, 2022, asprivate placement. AcelRx has agreed to pay the contingencies for conversionplacement agent a cash fee equal to 5.25% of these shares havethe aggregate gross proceeds generated from the private placement and to reimburse certain expenses of the placement agent in connection with the private placement in an amount not been met asto exceed $100,000. The placement agent will be entitled to an additional one-time payment of September 30, 2022.

26

15. Subsequent Event

Reverse Stock Split

On September 23, 2022, $200,000 upon the exercise of the Series A and Series B common stock warrants resulting in cumulative aggregate gross proceeds to AcelRx of at a special meeting of stockholders,least $9.5 million in cash. In addition, the Company's stockholders authorizedCompany has agreed to issue to the Company’s Board of Directorsplacement agent Series A common stock warrants, or placement agent Series A common stock warrants, to effect the Reverse Stock Split of all outstandingpurchase 183,824 shares of common stock in a range of 1-for-10 to 1-for-30 shares. The Board of Directors subsequently approved the Reverse Stock Split at a ratio of 1-for-20. The Reverse Stock Split became effective at 5:01 p.m. Eastern Time on October 25, 2022. The Company'sand Series B common stock began trading onwarrants, or placement agent Series B common stock warrants, to purchase 183,823 shares of common stock. These warrants have the Nasdaq Global Market onsame terms as the common stock warrants to be issued to the purchasers, except such warrants do not have a split-adjusted basis on October 26, 2022.Black Scholes provision in the event of a fundamental transaction and the exercise price of such warrants in $1.70 per share, which is 125% of the combined offering price per share.

 

The Reverse Stock Split is primarily intended to bringprivate placement closed on July 20, 2023 with the Company receiving aggregate gross proceeds of $10.0 million, before deducting the placement agent's fees and other offering expenses payable by the Company.

Registration Rights Agreement

The Company entered into compliance a registration rights agreement, dated July 17, 2023, with the minimum bid price requirements for maintaining its listing onPurchasers pursuant to which the Nasdaq Global Market.Company has agreed to file a registration statement under the Securities Act with the Securities and Exchange Commission, or the SEC, covering the resale of the shares of common stock to be issued in the private placement and the shares of common stock underlying the pre-funded warrants, the Series A common stock warrants and the Series B common stock warrants no later than 15 days following the date of the Purchase Agreement, and to use reasonable best efforts to have the registration statement declared effective as promptly as practical thereafter, and in any event no later than 90 days following the date of the Purchase Agreement in the event of a “full review” by the SEC.

 

20


 

Item 2. Managements Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q, or Form 10-Q, and with the audited consolidated financial statements and related notes thereto included as part of our Annual Report on Form 10-K for the year ended December 31, 2021,2022, or Annual Report.Report, which were recast to reflect discontinued operations and filed with the Companys Current Report on Form 8-K on August 1, 2023.

 

About AcelRx Pharmaceuticals, Inc.

 

We are a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for use in medically supervised settings.

 

Our Portfolio

 

Our portfolio of products and product candidates consists of sufentanil sublingual products and product candidates, pre-filled syringenafamostat product candidates and nafamostatpre-filled syringe product candidates, as further described below. On April 3, 2023, we closed the transactions contemplated by the Asset Purchase Agreement, or the DSUVIA Agreement, with Vertical Pharmaceuticals, LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or Alora, entered into on March 12, 2023, pursuant to which Alora acquired certain assets and assumed certain liabilities of AcelRx relating to its sufentanil sublingual tablet product referred to as DSUVIA or DZUVEO, or any other single-dose pharmaceutical product for use in medically supervised settings containing a sublingual tablet that includes sufentanil as the sole active ingredient, as a 30 mcg tablet or other dosage form or strength as reasonably necessary for lifecycle management, or the Product. Refer to Note 3, “Discontinued Operations” to the unaudited condensed consolidated financial statements to this Quarterly Report on Form 10-Q for additional information. We do not have plans to further develop any sufentanil sublingual product candidates.

Sufentanil Sublingual Products/Product Candidates

Product/Product

Candidate

Description

TargetUse

Status

DSUVIA® 

Sufentanil sublingual tablet, 30 mcg

Moderate-to-severe acute pain in a medically supervised setting, administered by a healthcare professional

Received U.S. Food and Drug Administration, or FDA, approval in November 2018; commercial launch began first quarter of 2019.

DZUVEO® 

Sufentanil sublingual tablet, 30 mcg

Moderate-to-severe acute pain in a medically monitored setting, administered by a healthcare professional

Granted European Commission, or EC, marketing approval in June 2018. Sunset date extended to December 31, 2022 by EC. Commercialized in Europe by Laboratoire Aguettant, or Aguettant.

Zalviso®

Sufentanil sublingual tablet system, 15 mcg

Moderate-to-severe acute pain in the hospital setting, administered by the patient as needed

In the U.S., positive results from Phase 3 trial, IAP312, announced in August 2017.

Approved in the European Union, where it was marketed commercially by Grünenthal GmbH, or Grünenthal, through May 12, 2021. Marketing Authorization withdrawn in July 2022. 

Future development and commercialization efforts contingent upon identification of corporate partnership resources.         

ARX-02

Higher Strength Sufentanil Sublingual Tablet

Cancer breakthrough pain in opioid-tolerant patients

Phase 2 clinical trial and End of Phase 2 meeting completed. Investigational New Drug, or IND, application was inactivated.

Future development contingent upon identification of corporate partnership resources.

ARX-03

Combination Sufentanil/Triazolam Sublingual Tablet

Mild sedation and pain relief during painful procedures in a physician’s office

Phase 2 clinical trial and End of Phase 2 meeting completed. IND application was inactivated.

Future development contingent upon identification of corporate partnership resources.

28

Pre-filled Syringe Product Candidates

Product/Product

Candidate

Description

TargetUse

Status

Ephedrine

Ephedrine pre-filled syringe, containing 10 ml of a solution of 3 mg/ml ephedrine for injection

Clinically important hypotension occurring in the setting of anesthesia

Product candidate licensed from Aguettant; preparing NDA for submission to FDA.

Approved in the European Union; owned and marketed by Aguettant.

Phenylephrine

Phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine for injection

Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia

Product candidate licensed from Aguettant; preparing NDA for submission to FDA.

Approved in the European Union; owned and marketed by Aguettant.

 

Nafamostat Product Candidates

 

Product/Product Candidate

 

Description

 

Target Use

 

Status

Niyad™

 

Lyophilized vial containing nafamostat for injection

 

Regional anticoagulant for injection into the extracorporeal circuit

 

Submitted an investigational device exemption, or IDE, and received Breakthrough Device Designation from the United States Food and Drug Administration, or FDA. Preliminary EUA submitted.Submitted a request for Emergency Use Authorization to the FDA.

       

LTX-608

 

Lyophilized vial containing nafamostat for injection

 

IV infusion as an anti-viral treatment for COVID-19

 

IND to be submitted following toxicology evaluation to enable Phase 2 study

       

LTX-608

 

Lyophilized vial containing nafamostat for injection

 

IV infusion for disseminated intravascular coagulation, or DIC

 

IND to be submitted following toxicology evaluation to enable Phase 2 study

       

LTX-608

 

Lyophilized vial containing nafamostat for injection

 

IV infusion for acute respiratory distress syndrome, or ARDS

 

IND to be submitted following toxicology evaluation to enable Phase 2 study

       

LTX-608

 

Lyophilized vial containing nafamostat for injection

 

IV infusion for acute pancreatitis

 

IND to be submitted following toxicology evaluation to enable Phase 2 study

 

Niyad is the first nafamostat product candidate we are developing to be used as a regional anticoagulant for injection into the extracorporeal circuit. There are currently no products approved by the FDA for use as an anticoagulant in the extracorporeal circuit. Niyad would be the first and only product approved for this indication, if approved. The current standards of care being used today are heparin and citrate. Heparin is a systemic anticoagulant and cannot be used in patients at risk of bleeding. Citrate is complex to administer and requires significant human resource time and attention given the nature of the product, and cannot be used in patients with liver failure, which is approximately 43% of acute kidney injury patients. Based on our market research of the CRRT market, heparin is used approximately 43% of the time, while citrate is used approximately 28% of the time. The remaining 29% of the time there is no anticoagulant used which is partly driven by the safety concerns with heparin or citrate. We believe the primary opportunity for Niyad is within the 57% of the market that uses either citrate or no anticoagulant.

2921

The second indication for our nafamostat product development candidate, LTX-608, on which we are focused is for the treatment of ARDS and DIC, an indication for which nafamostat is approved in Japan and South Korea. We have pending patent applications directed to the use of nafamostat in DIC, as an antiviral agent (e.g., COVID treatment), in ARDS and other indications.

Pre-filled Syringe Product Candidates

Product/Product Candidate

Description

TargetUse

Status

Fedsyra™

Ephedrine pre-filled syringe, containing 10 ml of a solution of 3 mg/ml ephedrine for injection

Clinically important hypotension occurring in the setting of anesthesia

Product candidate licensed from Aguettant; preparing New Drug Application, or NDA, for submission to FDA.Filing expected in 2023.

Approved in the European Union; owned and marketed by Aguettant.

Phenylephrine

Phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine for injection

Clinically important hypotension resulting primarily from vasodilation in the setting of anesthesia

Product candidate licensed from Aguettant; preparing NDA for submission to FDA.

Approved in the European Union; owned and marketed by Aguettant.

Our product candidates have been developed in a ready-to-use strength and pre-filled into syringes that can be immediately administered to patients, potentially eliminating the need for calculations and additional dilution and filling steps. We therefore believe that, if approved, our products may offer significant benefits to hospitals and surgery centers over the current compounded pre-filled syringe products. In addition, our pre-filled syringe product candidates will also compete with existing generic versions of concentrated vial forms of product, ready-to-use diluted vial forms of product, and for Fedsyra, two recently FDA-approved pre-filled syringes with a different formulation and/or concentration than our product candidate.

Overview

On April 3, 2023, we closed the transactions contemplated by the DSUVIA Agreement with Alora pursuant to which Alora acquired certain assets and assume certain liabilities relating to the Product. The Product expressly excludes Zalviso, any other multi-dose administration system containing sufentanil sublingual tablets (whether as the sole active ingredient or in combination with other active ingredients), and any single-dose formulation of sufentanil for use outside of a medically supervised setting. Under the Purchase Agreement, we are entitled to receive quarterly payments in an amount equal to 15% of net Product sales to all customers excluding net sales to the Department of Defense and sales by or on behalf of Aguettant, and quarterly payments in an amount equal to 75% of net Product sales to the Department of Defense. We are also entitled to receive sales milestones up to $116.5 million based on the achievement of Alora attaining certain levels of annual sales. Refer to Note 3, “Discontinued Operations” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

On January 7, 2022, we acquired Lowell Therapeutics, Inc., or Lowell, a privately held company, pursuant to the Agreement and Plan of Merger, dated as of November 14, 2021, or the Merger Agreement, in a transaction for consideration of approximately $32.5 million plus net cash acquired and certain other adjustments, and which includes up to approximately $26.0 million of contingent consideration payable in cash or stock at AcelRx’s option, upon the achievement of regulatory and sales-based milestones, or the Merger Agreement. In connection with the Merger Agreement we acquired Niyad and LTX-608 (lyophilized vials of nafamostat for injection into the extracorporeal circuit or direct IV infusion to the patient, respectively), an in-process research and development, or IPR&D, asset. For additional information regarding the Merger Agreement, see Note 4, “Asset Acquisition” to the consolidated financial statements in our 2022 Annual Report on Form 10-K for additional information.

On July 14, 2021, we entered into a License and Commercialization Agreement, or the PFS Agreement, with Laboratoire Aguettant, or Aguettant, pursuant to which we obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection and (ii) a phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine hydrochloride for injection. Aguettant will supply us with the products for use in commercialization and, if they are approved in the U.S., Aguettant was originally entitled to receive up to $24 million in sales-based milestone payments. In connection with our and Aguettant’s agreement to enter into the Amended DZUVEO Agreement (as defined below) and the Amended and Restated Supply Agreement (as defined below), we entered into an amendment to the PFS Agreement with Aguettant pursuant to which, effective on April 3, 2023, (a) Aguettant paid us a complementary payment in the amount of €1.5 million, and (b) the maximum amount in sales-based milestone payments that Aguettant is entitled to receive will reduce to $21 million.

22

On July 14, 2021, we also entered into a License and Commercialization Agreement, or the DZUVEO Agreement, with Aguettant pursuant to which Aguettant obtained the exclusive right to develop and commercialize DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom, or the DZUVEO Territory, for the management of acute moderate to severe pain in adults in medically monitored settings. We supply Aguettant with primary packaged product and Aguettant then completes secondary packaging of the finished product. Pursuant to the DSUVIA Agreement (as defined below), we and Aguettant entered into an amendment to the DZUVEO Agreement, or the Amended DZUVEO Agreement, and an amendment and restatement to the supply agreement with respect to the manufacture and supply of DZUVEO, or the Amended and Restated Supply Agreement. The rights and obligations under the Amended DZUVEO Agreement and the Amended and Restated Supply Agreement were assumed by Alora, as part of the DSUVIA asset divestment agreement. We received €2.5 million, or approximately $2.9 million, in 2021 under the DZUVEO Agreement. Refer to Note 4, “In-License Agreement” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

Our strategy is focused on developing, obtaining approval, and commercializing our product candidates, Niyad and the pre-filled syringes. Accordingly, we divested DSUVIA to Alora in April 2023, who will continue to commercialize the product and pay us sales-based milestone and other payments. We believe this will maximize the value of DSUVIA as Alora has more available resources to invest on DSUVIA commercialization and as a result can execute a more robust commercial plan to support DSUVIA sales expansion, while we further reduce our operating costs. We have no plans on further developing or commercializing any of our other sufentanil sublingual products that were previously our product candidates. We are focused on achieving an Emergency Use Authorization, or EUA, for Niyad in 2023, and if successful, we expect to begin commercialization, while also initiating the clinical study for full regulatory approval.

On October 25, 2022, we filed a certificate of amendment to our amended and restated certificate of incorporation to effect a 1-for-20 reverse stock split of our outstanding common stock, effective as of 5:01 p.m. Eastern Time on October 25, 2022, or the Reverse Stock Split. Unless expressly stated herein, all share amounts of our common stock presented in this Annual Report have been adjusted to reflect the Reverse Stock Split. See Note 1 to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

 

General Trends and Outlook

 

COVID-19-relatedGlobal Supply Chain

 

Government-mandated orders and related safety policies on account of the COVID-19 pandemic continue to prevent us from operating our business in the normal course. We continue to adhere to the various and diverse orders issued by government officials in the jurisdictions in which we operate. In addition, some hospitals, ambulatory surgery centers and other healthcare facilities have barred visitors that are not caregivers or mission-critical and otherwise restricted access to such facilities. As a result, the educational and promotional efforts of our commercial and medical affairs personnel have been substantially reduced, and in some cases, stopped. Cancellation or delays of formulary committee meetings and delays of elective surgeries have also affected the pace of formulary approvals and, consequently, the rate of adoption and use of DSUVIA. We expect our near-term sales volumes to continue to be adversely impacted as long as access to healthcare facilities by our commercial and medical affairs personnel continues to be limited, especially in light of the rise in COVID-19 cases associated with the emerging variants. We will continue to evaluate the impact on our revenues and related metrics and operating expenses during this period and assess the need to adjust our expenses and expectations.

As a result of COVID-19 and related international travel restrictions, in addition to the testing requirements of our vendor, the timing for testing and acceptance of our installed DSUVIA automated packaging line, and subsequent FDA approval, has been delayed. We are in discussions with our contract manufacturer as to expected timing of completion of validation testing required.

We will continue to engage with various elements of our supply chain and distribution channel, including our customers, contract manufacturers, and logistics and transportation providers, to meet demandsupply our product candidates for productsdevelopment purposes and to remain informed of any challenges within our supply chain. We continue to monitor demand and intend to adapt our plans as needed to continue to drive our business and meet our obligations during the evolving COVID-19 pandemic.product development programs. However, if the COVID-19 pandemic continues and persists for an extended period of time, we may face disruptions to our supply chain and operations, and associated delays in the manufacturing and supply of our products.products if the COVID-19 pandemic persists for an extended period of time and continues to impact our global supply chain. Such supply disruptions may adversely impact our ability to continue development of our product candidates and ultimately generate sales of and revenues from ourany approved products, and our business, financial condition, results of operations and growth prospects could be adversely affected.

As the global pandemic of COVID-19 continues to rapidly evolve, it could result in a significant long-term disruption of global financial markets, reducing our ability to access capital, which could in the future negatively affect our liquidity. The extent to which the COVID-19 pandemic continues to impact our business, our ability to generate sales of and revenues from our approved products, and our future clinical development and regulatory efforts will depend on future developments that are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions, quarantines and social distancing requirements in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the virus.

 

Inflation

 

We do not believe that inflation has had a material impact on our business or operating results during the periods presented. However, inflation, led by supply chain constraints, federal stimulus funding, increases to household savings, and the sudden macroeconomic shift in activity levels arising from the loosening or removal of many government restrictions and the broader availability of COVID-19 vaccines, has had, and may continue to have, an impact on overhead costs and transportation costs and may in the future adversely affect our operating results. In addition, increased inflation has had, and may continue to have, an effect on interest rates. Increased interest rates may adversely affect our borrowing rate and our ability to obtain, or the terms under which we can obtain, any potential additional funding.

 

Department of Defense

In April 2020, DSUVIA achieved Milestone C approval by the Department of Defense, or DoD, a decision that clears the path for the DoD to begin placing orders for DSUVIA for inclusion in all Army Sets, Kits, and Outfits, or SKOs, for deployed/deploying troops. This SKO fulfillment is dependent on the Army’s completion of their product information package including instructions on fulfillment and training which remains in process. In September 2020, we announced that DSUVIA was added to the DoD Joint Deployment Formulary, a core list of pharmaceutical products that are designated for deploying military units across all service branches. Also in September 2020, the U.S. Army awarded AcelRx with an initial contract of up to $3.6 million over four years for the purchase of DSUVIA to support a DoD-sponsored study, which is currently underway, to aid the development of clinical practice guidelines. Since the fourth quarter of 2020, DSUVIA orders are being fulfilled for the Army Prepositioned Stock Program, or APS. The aforementioned clinical and APS orders are separate from the planned SKO fulfillment.

3023

 

Recent Developments

 

On January 7, 2022,April 3, 2023, we acquired Lowell Therapeutics, Inc., or Lowell, inclosed our divestment of DSUVIA to Alora. In connection with the closing of the transaction, we received a transaction for considerationtotal of approximately $32.5$2.7 million plus net cash acquiredfrom Aguettant and certain other adjustments, inclusiveAlora. In connection with the closing, we also decided to fully repay our senior loan with Oxford Finance, LLC, or Oxford, leaving us debt-free after the closing of approximately $26.0 millionthe transaction.

On April 25, 2023, we executed a Memorandum of contingent consideration payableUnderstanding, or MoU, with a contract manufacturer, or the CMO, for the active pharmaceutical ingredient, or API for Niyad. The MoU provides us with a secured supply of nafamostat API on an exclusive basis outside of all Asian countries for our request for Emergency Use Authorization, or EUA, submitted to the FDA in cashApril 2023, and for our planned registrational study for Niyad later this year. The MoU also provides us access to the CMOs drug master file, or stock at AcelRx's option, uponDMF for the nafamostat API. AcelRx and the CMO are required to use good faith efforts to execute a Master Supply Agreement, or MSA, with exclusivity outside of Asian countries, which will ensure a long-term supply of nafamostat API. The MoU requires that we make payments to the CMO based on the achievement of regulatoryfour separate milestones: (a) execution of the MoU, (b) receipt of an EUA from the FDA, (c) an approved Pre-Market Application, or PMA, from the FDA, and sales-based(d) execution of the MSA. The MoU is considered legally binding on both parties.

On April 27, 2023, we submitted a request for EUA for Niyad and responded to previous questions outlined by the FDA in a prior submission made by Lowell. Our submission included information on the active pharmaceutical ingredient and finished drug product, including stability testing data and a process validation protocol for Niyad, amongst other items requested by the FDA.

On July 20, 2023, we closed the private placement of common stock, pre-funded warrants and common warrants for aggregate gross proceeds to us of $10.0 million, before deducting the placement agent's fees and other offering expenses payable by us, with an additional potential $16.3 million upon the exercise of the common warrants, which include an acceleration feature should the Company achieve certain performance milestones. For additional information regardingRefer to Note 10, “Subsequent Events” to the acquisition of Lowell, see Note 4. “Asset Acquisition” in the accompanying notes to theunaudited condensed consolidated financial statements.

On March 28, 2022, we received a close-out letter from the Office of Prescription Drug Promotion, or OPDP, of the U.S. Food and Drug Administration, or the FDA, to the Warning Letter we received on February 11, 2021 relating to certain DSUVIA-related promotional materials we used in 2019. The close-out letter indicated that the FDA had concluded its evaluation of our corrective actions in response to the Warning Letter and that we had addressed the issues raised by the Warning Letter.

On September 18, 2015, we sold the majority of the royalty rights and certain commercial sales milestones we were entitled to receive under the Collaboration and License Agreement, entered into on December 16, 2013, with Grünenthal GmbH, or Grünenthal, which was amended effective July 17, 2015 and September 20, 2016, or the Amended License Agreement, to PDL BioPharma, Inc., or PDL, in a transaction referred to as the Royalty Monetization. On August 31, 2020, PDL announced that it had sold its royalty interest for Zalviso to SWK Funding, LLC, or SWK. On May 31, 2022, we entered into a Termination Agreement with SWK to fully terminate the Royalty Monetization for which we paid cash consideration of $0.1 million, and neither PDL nor SWK retains any further interest in the Royalty Monetization. Accordingly, effective May 31, 2022, the Royalty Monetization is no longer reflected on our financial statements or other records as a sale of assets to PDL or SWK and all security interests and other liens of every type held by the parties to the Royalty Monetization have been terminated and automatically released without further action by any party. The $84.1 million gain on extinguishment of the liability related to the sale of future royalties is recognized in the condensed consolidated statements of operations as other income.

Reverse Stock Split

On October 25, 2022, we filed a certificate of amendment to our amended and restated certificate of incorporation to effect a 1-for-20 reverse stock split of our outstanding common stock, effective as of October 25, 2022, or the Reverse Stock Split. Unless expressly stated herein, all share amounts of our common stock presented in this Quarterly Report have been adjusted to reflect the Reverse Stock Split. See Notes 1 and 15 in the accompanying notes to the condensed consolidated financial statementson Form 10-Q for additional information.

 

Financial Overview

 

Although the termination of the Royalty Monetization resulted in net income for the nine months ended September 30, 2022, weWe have incurred net losses and generated negative cash flows from operations since inception and expect to continue to incur losses in the future as we continue commercialization activities to support the U.S. launch of DSUVIA, support European sales of DZUVEO by Aguettant, and fund any future research and development activities needed to support the FDA regulatory review of our product candidates.

 

We will incur capital expenditures related to our fully automated packaging line for DSUVIA, which has been installed, and awaits final site acceptance testing by our contract manufacturer and submission of final data to the FDA for approval. We anticipate that the fully automated line for DSUVIA will contribute to a significant decrease in costs of goods sold after FDA approval.

Our net loss for the three and six months ended SeptemberJune 30, 20222023 was $6.8$4.4 million and our$12.5 million, respectively, compared to net income for the ninethree and six months ended SeptemberJune 30, 2022 was $55.2 million, while our net loss for the three and nine months ended September 30, 2021 was $8.4of $70.7 million and $27.2$62.0 million, respectively. As of SeptemberJune 30, 2022,2023, we had an accumulated deficit of $418.3$438.4 million. As of SeptemberJune 30, 2022,2023, we had cash, cash equivalents restricted cash and short-term investments totaling $20.9$7.4 million compared to $51.6$20.8 million as of December 31, 2021.2022.

To extend our financial resources, we are realigning our cost structure from a focus on commercialization to a focus on advancing our recently acquired late-stage development pipeline, namely the pre-filled syringes and Niyad product candidates. As a result, we have also decided to not focus any development resources on Zalviso in the United States and do not expect to resubmit the Zalviso NDA in the foreseeable future. In addition, due to the termination of our agreements with Grünenthal for Zalviso in Europe and the related withdrawal of our Marketing Authorization in Europe in July 2022, we do not expect any revenues from Zalviso in Europe in the foreseeable future. Accordingly, we recorded a non-cash impairment charge of $4.9 million for the nine months ended September 30, 2022 related to Zalviso property and equipment. Future development of Zalviso will be contingent upon identification of corporate partnership resources.

We believe that the uptake of DSUVIA will be maximized through a partner with a larger commercial infrastructure and, as such, we are in discussions with potential partners that can execute a more robust commercial plan to support DSUVIA sales expansion, while further reducing our operating costs. The ultimate structure of a potential transaction with a third party may take multiple forms and is not known at this time.

31

 

Critical Accounting Estimates

 

The accompanying discussion and analysis of our financial condition and results of operations are based upon our unaudited condensed consolidated financial statements and the related disclosures, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts in our financial statements and accompanying notes. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. To the extent that there are material differences between these estimates and actual results, our future financial statement presentation, financial condition, results of operations and cash flows will be affected. Our critical accounting policies and estimates are detailed in our Annual Report.

 

There have been no significant changes to our critical accounting policies or significant judgements and estimates for the ninethree and six months ended SeptemberJune 30, 2022,2023, from those previously disclosed in our Annual Report, except as follows:

 

We recognize revenue in accordance with Accounting Standards Codification Topic 606, AcquisitionsRevenue from Contracts with Customers (ASC 606). We apply the following five steps in order to determine the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements:

 

identify the contract with a customer;

identify the performance obligations in the contract;

determine the transaction price;

allocate the transaction price to performance obligations in the contract; and

recognize revenue as the performance obligation is satisfied.

Our royalty revenue relates to our portion of net revenue earned on the sales of DSUVIA to the Department of Defense, or DoD, by Alora under the Marketing Agreement. Our performance obligation is to serve as the exclusive sales agent for selling DSUVIA to the DoD through the term of the Marketing Agreement. The non-creditable and non-refundable royalty revenues are variable consideration based on 75% of net sales of DSUVIA to the DoD during the period subject to certain adjustments. We evaluate acquisitions of assets and other similar transactions to assess whetherif we are a principal or not thean agent in a transaction should be accounted for as a business combination or asset acquisition by first applying a screen test to determine whether substantially allrevenue should be recorded on a gross or net basis depending on if we obtain control over the goods and services before they are transferred to customers. We are acting as an agent in relation to DSUVIA sales to the DoD.

The consideration in the Marketing Agreement reflects a variable amount, for which we estimate the amount of consideration to which we will be entitled in exchange for transferring the promised goods or services to a customer by using the expected value method or the most likely amount method. We include in the transaction price the amount for which it is probable that a significant reversal of cumulative revenue recognized will not occur. Royalty revenues are recognized when the DoD obtains control of the fair valueproduct, at which time we have an unconditional right to receive payment for such royalty earned.

Discontinued Operations

In accordance with ASC 205-20 “Presentation of Financial Statements: Discontinued Operations”, a disposal of a component of an entity or a group of components of an entity is required to be reported as discontinued operations if the disposal represents a strategic shift that has (or will have) a major effect on an entity’s operations and financial results. In the period in which the component meets held-for-sale or discontinued operations criteria the major current assets, non-current assets, current liabilities, and non-current liabilities shall be reported as components of total assets and liabilities separate from those balances of the gross assets acquired is concentrated in a single identifiable asset or groupcontinuing operations. At the same time, the results of similar identifiable assets. If so, the transaction is accounted forall discontinued operations, less applicable income taxes, shall be reported as an asset acquisition. If not, further determination is required as to whether or not we have acquired inputs and processes that have the ability to create outputs, which would meet the definitioncomponents of a business. Significant judgment is required in the application of the screen test to determine whether an acquisition is a business combination or an acquisition of assets.

Acquisitions meeting the definition of business combinations are accounted for using the acquisition method of accounting, which requires that the purchase price be allocated tonet loss separate from the net assets acquired at their respective fair values. In a business combination, any excessincome (loss) of the purchase price over the estimated fair values of the net assets acquired is recorded as goodwill.

For asset acquisitions, a cost accumulation model is used to determine the cost of an asset acquisition. Direct transaction costs are recognized as part of the cost of an asset acquisition. We also evaluate which elements of a transaction should be accounted for as a part of an asset acquisition and which should be accounted for separately. The cost of an asset acquisition, including transaction costs, is allocated to identifiable assets acquired and liabilities assumed based on a relative fair value basis. Goodwill is not recognized in an asset acquisition. Any difference between the cost of an asset acquisition and the fair value of the net assets acquired is allocated to the non-monetary identifiable assets based on their relative fair values. When a transaction accounted for as an asset acquisition includes an in-process research and development, or IPR&D, asset, the IPR&D asset is only capitalized if it has an alternative future use other than in a particular research and development project. For an IPR&D asset to have an alternative future use: (a) we must reasonably expect that we will use the asset acquired in the alternative manner and anticipate economic benefit from that alternative use, and (b) our use of the asset acquired must not be contingent on further development of the asset subsequent to the acquisition date (that is, the asset can be used in the alternative manner in the condition in which it existed at the acquisition date). Otherwise, amounts allocated to IPR&D that have no alternative use are expensed. Our asset acquisitions typically include contingent consideration arrangements that encompass obligations to make future payments to sellers contingent upon the achievement of future financial targets. Contingent consideration is not recognized until all contingencies are resolved and the consideration is paid or probable of payment, at which point the consideration is allocated to the assets acquired on a relative fair value basis.

Net Income (Loss) per Share of Common Stock

Basic and diluted loss per common share, or EPS, are calculated in accordance with the provisions of FASB ASC Topic 260, Earnings per Share.continuing operations.

 

Our Series A Redeemable Convertible Preferred Stock issued during the quarter ended September 30, 2022,DSUVIA business met the definition of a participating security given their rights to participatediscontinued operation as of March 31, 2023. Accordingly, we have classified the results of the DSUVIA business as discontinued operations in dividends if declared on common stock, which requires us to applyour unaudited condensed consolidated statements of operations for all periods presented. All assets and liabilities associated with the two-class method to compute both basicDSUVIA business were classified as assets and diluted net income or loss per share. The two-class method is an earnings allocation formula that treats participating securities as having rights to earnings that would otherwise have been available to common stockholders. In addition, as these securities are participating securities, we are required to calculate diluted net income or loss per share underliabilities of discontinued operations in the if-converted methodunaudited condensed consolidated balance sheets for the periods presented. All amounts included in additionthe notes to the two-class method and utilize the most dilutive result. In periods where there is a net loss, no allocation of undistributed net lossunaudited condensed consolidated financial statements relate to the Series A Redeemable Convertible Preferred stockholders is performed as the holders of these securities are not contractually obligated to participate in our losses.

continuing operations unless otherwise noted. For additional information, regarding the net income (loss) per share, see Note 14 “Net Income (Loss) per Share of Common Stock”.3, “Discontinued Operations” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q.

 

3224

 

Recently Adopted Accounting Pronouncements

In June 2016, the Financial Accounting Standards Board, or FASB, issued Topic 326, or the Credit Losses standard, which we adopted using a modified retrospective approach on January 1, 2023. Topic 326 requires that expected credit losses relating to financial assets measured on an amortized cost basis and available-for-sale debt securities be recorded through an allowance for credit losses. It also limits the amount of credit losses to be recognized for available-for-sale debt securities to the amount by which carrying value exceeds fair value. The adoption of this standard did not have a material impact on our financial statements or related disclosures.

We do not believe other recently issued but not yet effective accounting standards, if currently adopted, would have a material effect on our consolidated financial position, statements of operations and cash flows.

Results of Operations

 

As mentioned above, we are realigning our cost structure from a focus on commercialization to a focus on advancing our recently acquired late-stage development pipeline. In 2022, we have reduced our headcount-related expenses, primarily within the commercial organization. In the beginning of 2022, we employed 43 full-time employees. As of September 30, 2022, we employed 20 full-time employees. These reductions have resulted in, and will continue to result in, decreased operating expenses in 2022 and beyond. Our unaudited condensed consolidated results of operations have fluctuated from periodare presented for the three and six months ended June 30, 2023 and 2022. Certain financial results (revenues and expenses) relating to period and may continue to fluctuate in the future, based upon the progressdivestment of our commercial launch of DSUVIA, our research and development efforts, variationsDSUVIA/DZUVEO business are reflected in Note 3, “Discontinued Operations” to the level of expenditures related to commercial launch, development efforts and debt service obligations during any given period,unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information. Unless otherwise noted, the discussion below, and the uncertainty asrevenue and expense amounts discussed below, are based on and relate to the extent and magnitude of the impact from the COVID-19 pandemic. Results of operations for any period may be unrelated to results of operations for any other period. In addition, historical results should not be viewed as indicative of future operating results. In particular, to the extent our commercial and medical affairs personnel continue to be subject to varying levels of restriction on accessing hospitals and ambulatory surgical centers due to COVID-19, and to the extent government authorities and certain healthcare providers are continuing to limit elective surgeries, we expect our sales volume to be adversely affected.operations.

 

Three and NineSix Months Ended SeptemberJune 30, 20222023 and 20212022

 

Revenue

 

Product Sales Revenue

Product sales revenue consists of sales of DSUVIA in the United States and, prior to May 13, 2021, Zalviso in Europe.

Product sales revenue by product forFor the three and ninesix months ended SeptemberJune 30, 2022 and 2021, was as follows:

  Three Months Ended September 30,  Nine Months Ended September 30, 
  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

 
  (In thousands, except percentages) 

DSUVIA

 $507  $160  $347   217% $1,519  $733  $786   107%

Zalviso

           %     270   (270)  (100)%

Total product sales revenue

 $507  $160  $347   217% $1,519  $1,003  $516   51%

The increase in DSUVIA product sales revenue for the three and nine months ended September 30, 2022, as compared to the three and nine months ended September 30, 2021, was primarily the result of increased sales volume for DSUVIA and DZUVEO, partially due to purchases from our distributors in advance of our October 1, 2022 price increase. We expect inventory levels to decrease at these distributors over the next quarter or two and do not expect any returned product as a result of these sales. For the nine months ended September 30, 2021, there was2023, we recognized $0.3 million in product sales revenue of Zalviso by Grünenthal. In May 2020, Grünenthal terminated the Collaboration and License Agreement and the Manufacture and Supply Agreement, or together, the Grünenthal Agreements, accordingly the rights to market and sell Zalviso in Europe reverted back to us on May 12, 2021. In July 2022, the European Marketing Authorization for Zalviso was withdrawn.

On July 14, 2021, we granted Aguettant the license rights to DZUVEO in the European Union under the DZUVEO Agreement. As of September 30, 2022 and December 31, 2021, we had current and non-current portions of deferred revenue under the DZUVEO Agreement of $0.1 million and $1.1 million, respectively.

Contract and Other Collaboration Revenue

Contract and other collaboration revenue included revenue under the Grünenthal Agreements, related to research and development services, non-cash royalty revenue related to the sale of the majority of our royalty rights and certain commercial sales milestones to SWKDSUVIA Agreement with Alora under the Royalty Monetization,Marketing Agreement executed in April 2023, pursuant to which AcelRx has the exclusive right to market and royalty revenueoffer DSUVIA for sale to DoD and for which Alora pays us 75% of net sales of Zalviso in Europe. Contract and other collaboration revenue for the three and nine months ended September 30, 2021 was $0.06 million and $0.1 million, respectively.

33

Cost of Goods SoldDSUVIA sold to DoD.

 

Total cost of goods sold for the three and nine months ended September 30, 2022 and 2021, was as follows:

  Three Months Ended September 30,  Nine Months Ended September 30, 
  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

 
  (In thousands, except percentages) 

Direct costs

 $104  $134  $(30)  (22)% $558  $569  $(11)  (2)%

Indirect costs

  465   305   160   52%  1,671   1,950   (279)  (14)%

Total costs of goods sold

 $569  $439  $130   30% $2,229  $2,519  $(290)  (12)%

Direct costs from contract manufacturers for DSUVIA totaled $0.1 million and $0.6 million, respectively, for the three and nine months ended September 30, 2022. Direct costs from contract manufacturers for DSUVIA and Zalviso totaled $0.1 million and $0.6 million, respectively, in the three and nine months ended September 30, 2021, and included inventory impairment charges of $0.1 and $0.2 million, respectively, primarily related to DSUVIA and Zalviso component parts inventory. Direct cost of goods sold for DSUVIA and Zalviso includes the inventory costs of the active pharmaceutical ingredient, or API, third-party contract manufacturing costs, estimated warranty costs, packaging and distribution costs, shipping, handling and storage costs.

The indirect costs to manufacture DSUVIA totaled $0.5 million and $1.7 million for the three and nine months ended September 30, 2022, while the indirect costs to manufacture DSUVIA and Zalviso were $0.3 million and $2.0 million in the three and nine months ended September 30, 2021, respectively. Indirect costs include internal personnel and related costs for purchasing, supply chain, quality assurance, depreciation and related expenses.

Research and Development Expenses

 

The majority of our operating expenses to date have been for research and development activities related to Zalviso and DSUVIA. Research and development expenses included the following:

 

 

expenses incurred under agreements with contract research organizations and clinical trial sites;

 

employee-related expenses, which include salaries, benefits and stock-based compensation;

 

payments to third party pharmaceutical and engineering development contractors;

 

payments to third party manufacturers;

 

depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and equipment, and equipment and laboratory and other supply costs; and

 

costs for equipment and laboratory and other supplies.

 

We expect to incur future research and development expenditures to support the FDA regulatory review of our product candidates and anticipated activities required for the development of our nafamostat product candidates, and the preparation and submission of the NDAs for our two in-licensed pre-filled syringe, or PFS, product candidates from Aguettant.         Future development of Zalviso in the United States is contingent upon identification of corporate partnership resources.         

 

We track external development expenses on a program-by-program basis. Our development resources are shared among all our programs. Compensation and benefits, facilities, depreciation, stock-based compensation, and development support services are not allocated specifically to projects and are considered research and development overhead.

 

3425

 

Below is a summary of our research and development expenses forduring the three and ninesix months ended SeptemberJune 30, 2023 and 2022 and 2021:(in thousands, except percentages):

 

 Three Months Ended September 30,  Nine Months Ended September 30,  

Three Months Ended June 30,

  

Six Months Ended June 30,

 

Drug Indication/Description

 

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

  

2023

  

2022

  

$ Change

2023 vs.

2022

  

% Change

2023 vs.

2022

  

2023

  

2022

  

$ Change

2023 vs.

2022

  

% Change

2023 vs.

2022

 
 (In thousands, except percentages)  

DSUVIA

 $422  $646  $(224) (35)% $1,178  $990  $188  19%
 

(In thousands, except percentages)

 

Niyad

 $487  $257  $230  89

%

 $959  $257  $702  273

%

PFS

 189    189  100% 309    309  100%   64  (64

)

 (100

)%

 4  121  (117

)

 (97

)%

Niyad

 47    47  100% 305    305  100%

Zalviso

 2  5  (3

)

 (60

)%

 28  13  15  115

%

Overhead

  650   770   (120)  (16)%  2,375   2,119   256   12%  1,063   768   295   38

%

  1,608   1,539   69   4

%

Total research and development expenses

 $1,308  $1,416  $(108)  (8)% $4,167  $3,109  $1,058   34% $1,552  $1,094  $458   42

%

 $2,599  $1,930  $669   35

%

 

Research and development expenses for the three and six months ended SeptemberJune 30, 2022 decreased2023 increased as compared to the three and six months ended SeptemberJune 30, 2021,2022, primarily due to lower DSUVIA manufacturing-related development costs and compensation costs. ResearchNiyad-related research and development expenses for the nine months ended September 30, 2022 increased as compared to the nine months ended September 30, 2021, primarily due to PFS and Niyad development activities, increased DSUVIA manufacturing-related development costs, depreciation expense and compensation costs.

 

Selling, General and Administrative Expenses

 

Selling, general and administrative expenses consisted primarily of salaries, benefits and stock-based compensation for personnel engaged in commercialization, administration, finance and business development activities. Other significant expenses included allocated facility costs and professional fees for general legal, audit and consulting services.

 

Total selling, general and administrative expenses for the three and ninesix months ended SeptemberJune 30, 20222023 and 2021,2022, were as follows:follows (in thousands, except percentages):

 

  Three Months Ended September 30,  Nine Months Ended September 30, 
  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

  

2022

  

2021

  

$ Change

2022 vs. 2021

  

% Change

2022 vs. 2021

 
  (In thousands, except percentages) 

Selling, general and administrative expenses

 $5,262  $8,640  $(3,378)  (39)% $19,422  $24,978  $(5,556)  (22)%
  

Three Months Ended June 30,

  

Six Months Ended June 30,

 
  

2023

  

2022

  

$ Change

2023 vs. 2022

  

% Change

2023 vs. 2022

  

2023

  

2022

  

$ Change

2023 vs. 2022

  

% Change

2023 vs. 2022

 
                                 
  

(In thousands, except percentages)

 

Selling, general and administrative expenses

 $2,670  $3,960  $(1,290

)

  (33

)%

 $6,951  $8,060  $(1,109

)

  (14

)%

 

Selling, general and administrative expenses decreased by $3.4 million and $5.6 million for the three and ninesix months ended SeptemberJune 30, 2022, respectively,2023, as compared to the three and ninesix months ended September 30, 2021. The decrease for the three months ended SeptemberJune 30, 2022, as compared to the three months ended September 30, 2021, is primarily due to net decreasesa reduced headcount in selling, general and administrative expenses including $1.6 million in personnel-related expenses, including travel expense, $0.9 million in DSUVIA-related selling expenses, $0.3 million in business development expense, and $0.4 million in non-cash stock-based compensation expense. The decrease for the nine months ended September 30, 2022 as compared to the nine months ended September 30, 2021, is primarily due to net decreases in selling, general and administrative expenses including $2.6 million in personnel-related expenses, including travel expense, $1.5 million in DSUVIA-related selling expenses, $0.5 million in business development expense, and $1.1 million in non-cash stock-based compensation expense.2023.

Impairment of Property and Equipment

We have decided to not focus any development resources on Zalviso in the United States and do not expect to resubmit the Zalviso NDA in the foreseeable future. In addition, we do not expect any revenues from Zalviso in Europe in the foreseeable future. Accordingly, we determined that it is no longer probable that we will realize the future economic benefit associated with the costs of the Zalviso-related purchased equipment and manufacturing-related facility improvements we have made at our contract manufacturer and, therefore, recorded a non-cash impairment charge of $4.9 million to the Zalviso-related assets for the nine months ended September 30, 2022.

35

 

Other IncomeIncome(Expense)

 

Total other income (expense) for the three and ninesix months ended SeptemberJune 30, ,2023 and 2022, and 2021, was as follows:follows (in thousands, except percentages):

 

 Three Months Ended September 30, Nine Months Ended September 30,  Three Months Ended June 30,  Six Months Ended June 30,  
 

2022

  

2021

 

$ Change

2022 vs. 2021

 

% Change

2022 vs. 2021

 

2022

 

2021

 

$ Change

2022 vs. 2021

 

% Change

2022 vs. 2021

  

2023

 

2022

 

$ Change

2023 vs. 2022

 

% Change

2023 vs. 2022

 

2023

 

2022

 

$ Change

2023 vs. 2022

 

% Change

2023 vs. 2022

 
 (In thousands, except percentages)  

(In thousands, except percentages)

 

Interest expense

 $(247) $(538) $291  (54)% $(964) $(1,824) $860  (47)% $(15) $(293) $278  (95)% $(134) $(683) $549  (80)%

Interest income and other income (expense), net

 140  32  108  338% 229  92  137  149% (441) 51  (492) (965)% 5,070  89  4,981  5,597%

Non-cash interest income (expense) on liability related to sale of future royalties

   764  (764) (100)% 1,136  2,345  (1,209) (52)%   463  (463) (100)%   1,136  (1,136) (100)%

Gain on extinguishment of liability related to sale of future royalties

              84,052      84,052   100%     84,052   (84,052)  (100)%     84,052   (84,052)  (100)%

Total other income (expense)

 $(107) $258  $(365)  (141)% $84,453  $613  $83,840   13677% $(456) $84,273  $(84,729)  (101)% $4,936  $84,594  $(79,658)  (94)%

 

Interest expense consisted primarily of interest accrued or paid on our debt obligation agreements and amortization of debt discounts. Interest expense decreased for the three and ninesix months ended SeptemberJune 30, 2022,2023, as compared to the three and ninesix months ended SeptemberJune 30, 2021,2022, primarily as a result of a lower average outstanding loan balance. AsOn April 3, 2023, in connection with the closing of September 30, 2022, the outstanding balance due underDSUVIA Agreement, we fully repaid the Loan Agreement with Oxford was $7.4 million.Oxford. Refer to Note 75, “Long-Term Debt” into the accompanying notes to theunaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

26

 

Interest income and other income (expense), net, for the three and ninesix months ended SeptemberJune 30, 20222023 and 2021,2022, primarily consisted of interest earned on our investments and the changechanges in the fair value of our contingent put option.warrant liability, the Lowell holdback shares and interest earned on our investments. The decrease in interest income and other income, net for the three months ended June 30, 2023 as compared to 2022, was primarily due to the net effect of a $1.3 million increase in the fair value of our warrant liability partially offset by a $0.7 million gain on the satisfaction of the contingency related to the liability for the Lowell holdback shares issued in June 2023, while the increase for the six months ended June 30, 2023 as compared to 2022, was primarily due to the $4.0 million decrease in the fair value of our warrant liability.

 

The non-cash interest income on the liability related to the sale of future royalties is attributable to the Royalty Monetization that we completed in September 2015. As described inroyalty monetization which was fully terminated on May 31, 2022. Please refer to Note 911, “Liability Related to Sale of Future Royalties”, to the Royalty Monetization was recordedconsolidated financial statements in our 2022 Annual Report on Form 10-K for additional information.

Discontinued Operations

As of March 31, 2023, the DSUVIA business met all the conditions to be classified as debt underheld for sales, and because we consider the applicable accounting guidance. The effective interest income ratedivestiture of the DSUVIA business to be a strategic shift that will have a major effect on our operations and financial results, represented a discontinued operation. All assets and liabilities associated with DSUVIA/DZUVEO were therefore classified as assets and liabilities of discontinued operations in our unaudited condensed consolidated balance sheets for the nineperiods presented. Further, all historical operating results for DSUVIA/DZUVEO are reflected within discontinued operations in the unaudited condensed consolidated statements of operations for all periods presented. For the three months ended SeptemberJune 30, 2023, we recognized net income from discontinued operations of $0.1 million, and for the six months ended June 30, 2023, we recognized a net loss from discontinued operations $8.2 million. For the three and six months ended June 30, 2022, was approximately 3.2%, while the effective interest income rate for the nine months ended September 30, 2021 was approximately 3.6%.

On May 31, 2022, we entered into a Termination Agreement with SWK to fully terminate the Royalty Monetization and we recognized an $84.1net losses from discontinued operations of $3.6 million gain on extinguishment of the liability relatedand $7.7 million, respectively. Refer to Note 3, “Discontinued Operations” to the sale of future royalties.unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

 

Liquidity and Going ConcernCapital Resources

 

Liquidity and Going Concern

 

The termination of the Royalty Monetization resultedWe have incurred losses and generated negative cash flows from operations and we expect to incur significant losses in net income for the nine months ended September 30, 2022; however, before this, we had incurred recurring operating2023 and may incur significant losses and negative cash flows from operating activities since inception and we expect to continue to incur operating losses and negative cash flowsoperations in the future. These conditions raise substantial doubt aboutAlthough, we recently closed the private placement of our abilitycommon stock, pre-funded warrants and common warrants for aggregate gross proceeds to continue as a going concern. Consideringus of $10.0 million, before deducting the placement agent's fees and other offering expenses payable by us, with an additional potential $16.3 million upon the exercise of the common warrants, which include an acceleration feature should we achieve certain performance milestones (see Note 10, Subsequent Events), considering our current cash resources and current and expected levels of operating expenses for the next twelve months, we expect to need additional capital to fund our planned operations prior to the twelve-month anniversary of the filing date of this Quarterly Report on Form 10-Q. These conditions raise substantial doubt about our ability to continue as a going concern. We may seek to raise such additional capital through public or private equity offerings, including under the Controlled Equity OfferingSM Sales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, debt securities, monetizea new debt facility, monetizing or securitizesecuritizing certain assets, refinance our loan agreement, enterentering into product development, license or distribution agreements with third parties, or divest DSUVIA in the United States, DZUVEO in Europe, ordivesting any of our product candidates. On April 26, 2023, we received a notice from Nasdaq stating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for 30 consecutive business days. On June 15, 2023, we received notice from Nasdaq confirming that we had cured the bid price deficiency and had regained compliance with the Minimum Bid Price Rule, and that this matter is now closed. This notice had no immediate effect on the Nasdaq listing or trading of our common stock; however, our depressed stock price will make it more difficult for us to raise additional capital through equity offerings. Please see “Part II., Item 1A. Risk Factors— Risks Related to Ownership of Our Common Stock — If we cannot maintain compliance with Nasdaq’s continued listing requirements, our common stock may be delisted from The Nasdaq Global Market.” While we believe our plans to raise additional funds will alleviate the conditions that raise substantial doubt about our ability to continue as a going concern, these plans are not entirely within our control and cannot be assessed as being probable of occurring. Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available, we may be required to further reduce our workforce, reduce the scope of, or cease, the commercial launch of DSUVIA, or the development of our product candidates in advance of the date on which our cash resources are exhausted to ensure that we have sufficient capital to meet itsour obligations and continue on a path designed to preserve stockholder value. In addition, if we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish rights to our technologies, future revenue streams or product candidates, or to grant licenses on terms that may not be favorable to us.

 

We have funded our operations primarily through issuance of equity securities, borrowings, payments from Grünenthal, monetization of certain future royalties and commercial sales milestones from the European sales of Zalviso by Grünenthal, funding of approximately $22.6 million from the U.S. Department of Defense, and more recentlyDoD, with revenues from sales of DSUVIA sincewhich we recently divested to Alora, and payments under the commercial launch in the first quarter of 2019 and the upfront payment under theAmended DZUVEO Agreement with Aguettant.

 

3627

 

As of SeptemberJune 30, 2022,2023, we had cash, cash equivalents restricted cash and short-term investments totaling $20.9$7.4 million, compared to $51.6$20.8 million as of December 31, 2021.2022. The decrease was primarily due to cash required to fund our continuing operations, including debt service,repayment of the Loan Agreement with Oxford, development activities for our newly acquired late-stage pipeline product candidates, commercialization activities for DSUVIA, including installation of our automated packaging line for DSUVIA, and business development activities. If we are unsuccessful in our efforts to raise additionalactivities, including the divestment of DSUVIA. Our existing capital based on our current and expected levels of operating expenses our current capital will not be sufficient to fund our operations for the next twelve months andresources will not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain our operations.

 

We enteredPursuant to the ATM Agreement with Cantor, as our agent, pursuant to which we may offer and sell, from time to time through Cantor, shares of our common stock. We issued and sold approximately 0.04 million shares of common stock pursuant toThere were no sales under the ATM Agreement and received net proceeds of $0.2 million, after deducting fees and expenses for the three and ninesix months ended SeptemberJune 30, 2023 or 2022. For the nine months ended September 30, 2021, we issued and sold approximately 0.2 million shares of common stock pursuant to the ATM Agreement, and received net proceeds of approximately $7.5 million, after deducting fees and expenses. As of SeptemberJune 30, 2022, we may offer and sell shares2023, approximately $35.6 million of our common stock having an aggregate offering price of up to $35.9 millionremained available for sale and issuance under the ATM Agreement.Agreement; however, our ability to sell such shares under the shelf registration statement and the ATM Agreement will be limited until we are no longer subject to the SEC's "baby shelf" limitations.

 

On May 30, 2019, we entered into the Loan Agreement with Oxford. Under the Loan Agreement, we borrowed an aggregate principal amount of $25.0 million under a term loan. After deducting all loan initiation costs and outstanding interest on the prior loan agreement with Hercules, we received $15.9 million in net proceeds. As of September 30, 2022,March 31, 2023, the outstanding balance due under the Loan Agreement with Oxford was $7.4$3.3 million. For more information, seeOn April 3, 2023, in connection with the closing of the DSUVIA Agreement, we fully repaid the Loan Agreement with Oxford. Refer to Note 75, “Long-Term Debt” into the accompanying notes to theunaudited condensed consolidated financial statements.statements in this Quarterly Report on Form 10-Q for additional information.

On July 17, 2023, we entered into a securities purchase agreement, or the Purchase Agreement, with several institutional investors, or the Purchasers, relating to the issuance and sale to the Purchasers in a private placement of 5,340,591 shares of common stock, par value $0.001 per share, pre-funded warrants to purchase up to an aggregate of 2,012,356 shares of common stock at an exercise price of $0.001 per share; Series A common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share; and Series B common stock warrants to purchase up to an aggregate of 7,352,947 shares of common stock at an exercise price of $1.11 per share. Refer to Note 10, “Subsequent Events” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information.

 

Our cash and investment balances are held in a variety of interest-bearing instruments, including obligations of commercial paper, corporate debt securities, U.S. government sponsored enterprise debt securities and money market funds. Cash in excess of immediate requirements is invested with a view toward capital preservation and liquidity. We do not expect COVID-19 to have a material impact on our high quality, short-dated investments.

 

Cash Flows

 

The following is a summary of our cash flows for the periods indicated and has been derived from our unaudited condensed consolidated financial statements which are included elsewhere in this Form 10-Q (in thousands):

 

  

Nine Months Ended September 30,

 
  

2022

  

2021

 

Net cash used in operating activities

 $(22,918) $(21,998)

Net cash provided by (used in) investing activities

  33,790   (21,684)

Net cash (used in) provided by financing activities

  (5,803)  29,679 
  

Six Months Ended June 30,

 
  

2023

  

2022

 

Net cash used in operating activities

 $(10,583) $(17,680)

Net cash provided by investing activities

  3,123   29,348 

Net cash used in financing activities

  (5,405)  (4,166)

 

Cash Flows from Operating Activities

 

The primary use of cash for our continuing operating activities during these periods was to support our product development efforts for our product candidates while the primary use of cash for discontinued operations was to fund commercial activities for our approved product, DSUVIA, and more recently for development of our newly acquired late-stage pipeline product candidates.DSUVIA. Our cash used in operating activities also reflected changes in our working capital, net of adjustments for non-cash charges, such as stock-based compensation, depreciation and amortization of our fixed assets, stock-based compensation, non-cash interest income (expense) related to the sale of future royalties and interest expense related to our debt financings.

 

Cash used in operating activities of $22.9$10.6 million during the ninesix months ended SeptemberJune 30, 2023, reflected a net loss of $12.5 million, partially offset by aggregate non-cash charges of $3.1 million and included an approximate $1.2 million net change in our operating assets and liabilities. Non-cash adjustments included an impairment charge of $6.9 million on our net assets held for sale in connection with our divestment of DSUVIA, an impairment charge of $1.1 million on fixed assets, a gain of $1.1 million related to the termination of lease liabilities, a $4.0 million decrease in the fair value of our warrant liability and $1.0 million in stock-based compensation expense, a $0.4 million gain on extinguishment of debt, and $0.3 million in depreciation and amortization expense. The net change in our operating assets and liabilities included a $1.1 million decrease in prepaid expenses and other assets and a $1.4 million decrease in accrued liabilities.

28

Cash used in operating activities of $17.7 million during the six months ended June 30, 2022, reflected net income of $55.2$62.0 million, offset by aggregate non-cash itemsinflows of $76.6$77.7 million and included an approximate $1.6$2.0 million net change in our operating assets and liabilities. Non-cash inflows included an $84.2 million gain on the termination of the Royalty Monetization, partially offset by a $4.9 million charge for the impairment of Zalviso-related property and equipment and $2.2$1.5 million in stock-based compensation expense. The net change in our operating assets and liabilities included a $1.5$1.6 million decrease in accrued liabilities.

Cash usedliabilities and a $0.4 million decrease in operating activities of $22.0 million during the nine months ended September 30, 2021, reflected a net loss of $27.2 million, partially offset by aggregate non-cash charges of $3.3 million and included an approximate $1.9 million net change in our operating assets andlease liabilities. Non-cash charges included $3.5 million for stock-based compensation expense, $2.3 million in non-cash interest income on the liability related to the Royalty Monetization, and $1.5 million in depreciation and amortization expense. The net change in our operating assets and liabilities included a $1.2 million increase in deferred revenue.

37

 

Cash Flows from Investing Activities

 

Our investing activities have consisted primarily of our capital expenditures and purchases and sales and maturities of our available-for-sale investments.

 

During the ninesix months ended SeptemberJune 30, 2023, cash provided by investing activities of $3.1 million was primarily the net result of $2.7 million in cash proceeds on the sale of DSUVIA to Alora, $0.5 million in proceeds from the maturities of investments partially offset by $0.1 million for purchases of property and equipment.

During the six months ended June 30, 2022, cash provided by investing activities of $33.8$29.3 million was primarily the net result $43.2$38.6 million in proceeds from maturity of investments partially offset by $7.4 million for purchases of investments and $1.7 million in cash paid for the Lowell asset acquisition, net of cash acquired. During the nine months ended September 30, 2021, cash used in investing activities of $21.7 million was primarily the net result of $53.8 million for purchases of investments and $1.8 million for purchases of property and equipment, partially offset by $34.0 million in proceeds from the sale and maturity of investments.

 

Cash Flows from Financing Activities

 

Cash flows from financing activities primarily reflect proceeds from the sale of our securities and payments made on debt financings.

 

During the ninesix months ended SeptemberJune 30, 2022,2023, cash used in financing activities of $5.8$5.4 million was primarily due to long-term debt payments under the Loan Agreement with Oxford. During the ninesix months ended SeptemberJune 30, 2021,2022, cash provided byused in financing activities of $29.7$4.2 million was primarily due to $36.4 million in net proceeds receivedlong-term debt payments under the Loan Agreement with Oxford. On April 3, 2023, in connection with equity financings, partially offset by $6.7 million usedthe closing of the DSUVIA Agreement, we fully repaid the Loan Agreement with Oxford. Refer to Note 5, “Long-Term Debt” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for payment of long-term debt.additional information.

 

Capital Commitments and Capital Resources

 

Our current operating plan includes expenditures related to the development of our product candidates and the continued launch of DSUVIA in the United States.candidates. In addition, on January 7, 2022, we acquired Lowell in a transaction for consideration of approximately $32.5 million plus net cash acquired and certain other adjustments, inclusive of approximately $26.0 million of contingent consideration payable in cash or stock at AcelRx'sAcelRx’s option, upon the achievement of regulatory and sales-based milestones. For additional information regarding the acquisition of Lowell, see Note 4.4, “Asset Acquisition” in the accompanying notes to the condensed consolidated financial statements.statements in our 2022 Annual Report on Form 10-K for additional information. Our operating plan includes anticipated activities required for the development and supply of our nafamostat product candidates, and the preparation and submission of the NDAs for our two in-licensed PFS product candidates from Aguettant. These assumptions may change as a result of many factors. We will continue to evaluate the work necessary to successfully launch DSUVIA and gain approval of our product candidates in the United States and intend to update our cash forecasts accordingly. Considering our current cash resources and current and expected levels of operating expenses for the next twelve months, we expect to need additional capital to fund our planned operations for at least the next twelve months.

 

Our future capital requirements may vary materially from our expectations based on numerous factors, including, but not limited to, the following:

 

 

the ability to retain the listing of our common stock on the Nasdaq exchange;

the duration, impact and timing of COVID-19 on our operations, our sales representatives’ access to hospitals or other healthcare facilities, and our level of sales;

 

expenditures related to the launch of DSUVIA and potential commercialization of our product candidates, if approved;

 

expenditures related to drafting and submission of new drug or device regulatory applications with the USU.S. Food and Drug Administration, or the FDA, for our developmental product candidates and payment of statutory filing fees and related application prosecution costs arising from such submissions;

future manufacturing, selling and marketing costs related to DSUVIA and our product candidates, if approved, including our contractual obligations to Aguettant under the DZUVEO Agreement;

the ability to identify and secure potential partnerships with a third party having sufficient commercial resources to develop and potentially grow the DSUVIA asset;

 

costs associated with business development activities and licensing transactions;

29

 

the outcome and timing of the regulatory submissions for our product candidates, including our two in-licensed product candidates from Aguettant, and any approvals for our product candidates;

 

the outcome, timing and cost of the development of our nafamostat product candidates;

 

the initiation, progress, timing and completion of any post-approval clinical trials for DSUVIA, or our product candidates, if approved;

 

changes in the focus and direction of our business strategy and/or research and development programs;

 

38

 

milestone and royalty revenue we receive under our collaborative development and commercialization arrangements, including the DZUVEO Agreement;arrangements;

 

delays that may be caused by changing regulatory requirements;

 

the costs involved in filing and prosecuting patent applications and enforcing and defending patent claims;

 

the timing and terms of future in-licensing and out-licensing transactions;

 

the cost and timing of establishing sales, marketing, manufacturing and distribution capabilities;

 

the cost of procuring clinical supplies of our product candidates, and commercial supplies, of DSUVIA and our product candidates, if approved;

 

the cost of establishing new supply chains and related third party logistics to support our developmental product candidates;

 

the extent to which we acquire or invest in businesses, products and product candidates or technologies; and

 

the expenses associated with litigation.

 

In the long-term,long term, our existing capital resources will not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain our operations. We will have to raise additional funds through the sale of our equity securities, monetization of current and future assets, issuance of debt or debt-like securities or from development and licensing arrangements to sustain our operations and continue our development programs.

 

Please see “Part II., Item 1A. Risk Factors—Risks Related to Our Financial Condition and Need for Additional Capital.”

We have material cash requirements and other contractual obligations related to our Loan Agreement with Oxford (as described in Note 7 “Long-Term Debt” in the accompanying notes to the condensed consolidated financial statements) and contract manufacturing services and office rent (as described in Note 8 “Leases” in the accompanying notes to the condensed consolidated financial statements).

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934, as amended, or the Exchange Act, and are not required to provide the information specified under this item.

 

Item 4. Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Exchange Act Rule 13a–15(e) and 15d-15(e)) that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, or the Exchange Act, and the rules and regulations thereunder, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, to allow for timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management is required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.

 

Remediation of Previously Reported Material Weakness

As disclosed in the section titled “Risk Factors” in Part II, Item 1A of this Quarterly Report on Form 10-Q, we previously identified a material weakness in our internal control over financial reporting related to the review procedures related to the technical accounting review and analysis over earnings per share calculations that were insufficient to prevent or detect errors in the calculation. Specifically, the error was due to management’s failure to identify warrants issued in November 2021 as participating securities and consequently attribute earnings to these securities as part of a two-class EPS calculation. This material weakness resulted in the restatement of our unaudited condensed consolidated financial statements for the quarterly periods ended June 30, 2022 and September 30, 2022.

We have implemented measures to remediate the identified material weakness. Those remediation measures include enhanced processes to identify and appropriately apply applicable accounting requirements related to the earnings per share calculation to better evaluate and understand the nuances of the complex accounting standards that apply to our financial statements. We continue to provide access to accounting literature, research materials and documents, have enhanced the review and analysis process around the earnings per share calculation and increased communications among our personnel and third-party professionals with whom we consult regarding complex accounting applications.

30

These actions resulted in an improved internal control environment that was in place for a period of time to allow for our management to conclude, based on evidence obtained in validating the design and operating effectiveness of these controls, that we have fully remediated the material weakness in the review procedures related to the technical accounting review and analysis over earnings per share calculations as of June 30, 2023. 

Evaluation of disclosure controls and procedures. As required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of the end of the period covered by this Quarterly Report on Form 10-Q. In accordance with guidance issued byBecause of the SEC, companies are permitted to exclude acquisitions from their final assessment ofmaterial weakness in our internal control over financial reporting previously disclosed in our Annual Report on Form 10-K for the fiscal year inended December 31, 2022, which were recast to reflect discontinued operations and filed with the acquisition occurred while integrating the acquired operations; our management’s evaluation of internal control over financial reporting excluded the internal control activities of Lowell which are included in our consolidated financial statements. BasedCompany’s Current Report on the foregoing,Form 8-K on August 1, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of December 31, 2022, our disclosure controls and procedures were effective atnot effective. In light of this fact, our management, including our Chief Executive Officer and Chief Financial Officer, has performed an enhanced review and analysis of the reasonable assurance level.process around the earnings per share calculation and increased communications among our personnel and third-party professionals with whom we consult and has concluded that, notwithstanding the material weakness in our internal control over financial reporting, the unaudited condensed consolidated financial statements for the periods covered by and included in this Quarterly Report on Form 10-Q fairly present, in all material respects, our financial position, results of operations and cash flows for the periods presented in conformity with U.S. GAAP.

 

Changes in internal control over financial reporting. There have beenAside from the remediation of the material weakness relating to our internal control over financial reporting, as described above, there were no other changes in our internal control over financial reporting that occurred during our most recent fiscal quarterthe period covered by this Quarterly Report on Form 10-Q that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.


 

PART II. OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may be involved in legal proceedings relating to intellectual property, commercial, employment and other matters arising in the ordinary course of business. Such matters are subject to uncertainty and there can be no assurance that such legal proceedings will not have a material adverse effect on our business, results of operations, financial position or cash flows. Please see the matters under the caption “Part I. Financial Information—Item 1. Financial Statements—Note 10,6, Commitments and Contingencies—Litigation.”

 


 

Item 1A. Risk Factors

 

This Quarterly Report on Form 10-Q contains forward-looking information based on our current expectations. Because our actual results may differ materially from any forward-looking statements made by or on behalf of us, this section includes a discussion of important factors that could affect our actual future results, including, but not limited to, our revenues, expenses, net loss and loss per share. You should carefully consider these risk factors, together with all of the other information included in this Quarterly Report on Form 10-Q as well as our other publicly available filings with the U.S. Securities and Exchange Commission, or SEC.

 

Summary Risk Factors

 

Our business is subject to numerous risks, as more fully described in this section below this summary. You should read these risks before you invest in our common stock. We may be unable, for many reasons, including those that are beyond our control, to implement our business strategy. In particular, our risks include:

 

 

Our businessEmergency Use Authorization, or EUA, application for Niyad™ is being adversely impacted bypremised on the COVID-19 pandemic.significant potential public health emergency involving COVID-19.

We may fail to realize the benefits expected from our acquisition of Lowell Therapeutics, Inc., or Lowell, which could adversely affect our stock price.

We are dependent on the ability of Vertical Pharmaceuticals, LLC, a wholly owned subsidiary of Alora Pharmaceuticals, LLC, or together Alora, to successfully commercialize DSUVIA in order to receive royalties from DSUVIA. If Alora is unable to successfully commercialize DSUVIA, our business, financial condition, and results of operations will be materially harmed.

Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales.

 

Our Emergency Use Authorizationdrug discovery and development efforts might not generate successful product candidates.

If clinical trials of our product candidates fail to demonstrate safety and efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

If we experience delays or difficulties in enrolling patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

If serious adverse effects or unexpected characteristics of our product candidates are identified during development, we may need to abandon or limit our development of some or all of our product candidates.

We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.

The process for obtaining approval of a Premarket Approval, or PMA, or New Drug Application, for Niyad™or NDA, is premised ontime consuming, subject to unanticipated delays and costs, and requires the declared COVID-19 health emergency.commitment of substantial resources.

Our expectations for U.S. Food and Drug Administration, or FDA, approvability of our product candidates may be inaccurate.

We may experience difficulties in retaining our existing employees and managing our operations.

If we, or current and potential partners, are unable to compete effectively, our products may not reach their commercial potential.

Coverage and adequate reimbursement may not be available for our product candidates, if approved, in the United States and in Europe, which could make it difficult for us, or our partners, to sell our products profitably.

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If we or our partners are unable to establish and maintain relationships with group purchasing organizations any future revenues or future profitability could be jeopardized.

Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices we may obtain.

 

We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.

We have not yet generated significant product revenue and may never be profitable.

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

Our effective tax rate may fluctuate, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

 

We require additional capital and may be unable to raise such capital, which would force us to delay, reduce or eliminate our commercialization efforts and product development programs and could cause us to be unable to continue to operate as a going concern and cease operations.

 

WeTo fund our operations, and capital requirements, we may sell additional equity securities, which may result in dilution to our stockholders, or debt securities, which may impose restrictions on our business.

The terms of our loan agreement with Oxford may restrict our current and future operations.

We might be unable to service our existing debt due to lack of cash flow and might be subject to default.

Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices we may obtain.

If we are unable to compete effectively, our products may not reach their commercial potential.

Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices that we may obtain.

Governmental guidelines and recommendations published and existing laws and regulations can reduce the use of DSUVIA® in the United States.

DSUVIA may cause adverse effects or have other properties that could limit market acceptance.

We face extensive regulatory requirements for our products and product candidates.

DSUVIA requires a REMS program.

Failure to receive required quotas of controlled substances or comply with the Drug Enforcement Agency regulations, or the cost of compliance with such regulations may adversely affect our business.

Our success is dependent on successful commercialization of DSUVIA.

 

We have limited experience commercializing DSUVIA.not yet generated significant product revenue and may never be profitable.

32

 

Future sales of DSUVIA to the Department of Defense, or DoD, are not predictable, may occur on an irregular basis and may not meet our expectations due to various United States government-related factors that are beyond our control.

 

The commercial success of DSUVIAWe rely on third party manufacturers and if approved,suppliers for our product candidates in the United States as well as DZUVEO® in Europe, will depend upon the acceptance of those products.

Risks associated with our international operations could materially adversely affect our business.

Formulary approvals for DSUVIA or our product candidates, if approved, may not be achieved, or could be subject to certain restrictions, which could make it difficult for us to sell our products.

Coverage and adequate reimbursement may not be available for DSUVIA or our product candidates, if approved.Europe.

We may be unable to maintain or grow our sales and marketing capabilities for our products and, if approved, our product candidates.
 

We rely on limited sources of supply for the active pharmaceutical ingredients for nafamostat-based product candidates and any disruptions in the chain of supply may experience difficultiescause a delay in retainingdeveloping our existing employeesproduct candidates.

Manufacturing issues may arise that could delay or increase costs related to product development and managingregulatory approval.

We rely on third parties to conduct, supervise and monitor our operations.clinical trials.

Our relationships with clinical investigators, health care professionals, consultants, commercial partners, third-party payers, hospitals, and other customers are subject to applicable anti-kickback, fraud and abuse and other healthcare laws, which could expose us to significant penalties.

Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us.

Business interruptions could delay our operations and sales efforts.

 

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

 

Potential governmentalWe may acquire companies, product candidates or products or engage in strategic transactions.

We face potential product liability claims and, legal action regarding our commercialization of opioids could adversely affect our business, financial condition, results of operations and cash flows.if such claims are successful, we may incur substantial liability.

 

Our expectations for FDA approvability of our product candidatesemployees, agents and vendors may be inaccurate,

41

Delaysengage in clinical trials could result in increased costsmisconduct or other improper activities, including non-compliance with regulatory standards and jeopardize or delay our ability to obtain regulatory approvalrequirements and commence product sales.insider trading.

 

The process for obtaining approval of an NDA is time consuming and is subjectIf we cannot defend our issued patents from third party claims or if our pending patent applications fail to unanticipated delays and costs.issue, our business could be adversely affected.

 

We rely on third parties to conduct, superviseLitigation involving patents, patent applications and monitor our clinical trials,other proprietary rights is expensive and time consuming.

 

We rely on third party manufacturersIt is difficult and suppliers forcostly to protect our products in the United Statesproprietary rights, and Europe.

We rely on limited sources of supply for the active pharmaceutical ingredient for DSUVIA.

Manufacturing issues may arise that could delay or increase costs related to commercialization, product development and regulatory approval.

Our acquisition of Lowell Therapeutics, Inc, or Lowell,we may not be successful.able to ensure their protection.

 

We may not succeed in establishing and maintaining collaborative relationships to commercialize and fund our product development activities.

We may not be able to defend our issued patents from third party claims and our pending patent applications may fail to issue.

Potential litigation involving our patents, patent applications and other proprietary rights could cause delays in bringing our products to market and interfere with our business.

We may not be able to enforce or ensure the protection of our intellectual property and rights in the United States and throughout the world.

We may not be ableunable to adequately prevent disclosure of trade secrets and other proprietary information.

 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be payable to the United States Patent and Trademark Office and various foreign governmental patent agencies annually in several stages over the lifetime of the patents and/or applications.

We may not be able to enforce our intellectual property rights throughout the world.

We have not yet registered our trademarks in all our potential markets, and failure to secure those registrations could adversely affect our business.

The market price of our common stock has historically been and may continue to be highly volatile.

 

Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall.

 

We face potential product liability claimsdo not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if such claims are successful,doing so would benefit our stockholders or remove our current management.

If we cannot maintain compliance with Nasdaq’s listing requirements, Nasdaq may incur substantial liability.delist our securities from trading on its exchange, which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.

 

Litigation may substantially increase our costs and harm our business.

Our relationships with third parties are subject to applicable anti-kickback, fraud and abuse and other healthcare laws, which could expose us to significant penalties.

Our employees, agents and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

 

Our involvement in securities-related class action and related derivative litigation could divert our resources and management's attention and harm our business.

 

WeOur ability to use our net operating loss carryforwards and certain other tax attributes may acquire companies, product candidates or products or engage in strategic transactions.be limited.

 

SignificantOur effective tax rate may fluctuate, we may be adversely affected by changes in tax laws and regulations, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

Macroeconomic uncertainties, including inflationary pressures, supply chain disruptions, labor shortages, significant volatility in global markets, recession risks, and the COVID-19 pandemic have in the past and may continue to adversely affect our business, future results of operations, and financial condition, the effects of which remain uncertain.  

We previously identified a material weakness in our information technology systemsinternal control over financial reporting. In the future, we may identify additional material weaknesses or data security incidents couldotherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, which may result in significantmaterial errors in our financial legal, regulatory, business and reputational harmstatements or cause us to us.fail to meet our period reporting obligations.

 

42


 

Risks Related to COVID-19 Pandemic

 

Our business is being adversely impacted by the COVID-19 pandemic.

Our business has been adversely affected by the COVID-19 outbreak. Federal, state, local and foreign government orders on account of the COVID-19 pandemic are preventing us from conducting certain activities. Following local and state government orders in California, where our corporate office is located and many of our employees live, we implemented work from home policies, which are limiting certain of our operations. If the COVID-19 outbreak continues, we may need to limit operations further and implement additional limitations, such as extending our work from home policies.

In response to the COVID-19 pandemic, some hospitals, ambulatory surgery centers and other healthcare facilities have barred visitors that are not caregivers or mission-critical and we have no visibility as to when these restrictions on access will be lifted for all of our customers. As a result, our commercial and medical affairs teams’ educational and promotional efforts have been reduced, and in some cases, stopped. Furthermore, some governments, hospitals and doctors, as a measure to combat the further spread of COVID-19, reduced the number of procedures in which DSUVIA is administered as part of the pain treatment program, and temporarily halted performing elective surgeries, which adversely impacted the level of our sales relating to such procedures. We expect our near-term sales volumes to be adversely impacted for as long as access to healthcare facilities by our commercial and medical affairs personnel and the number of procedures in which DSUVIA is administered continues to be limited. The ultimate impact of the COVID-19 outbreak remains highly uncertain and subject to change. We do not yet know the full extent of potential delays or impacts on our business, healthcare systems or the global economy as a whole. However, these effects could have a material impact on our operations, and we will continue to monitor the COVID-19 situation closely.

Our Emergency Use Authorization Applicationapplication for Niyad is premised on the declared COVID-19significant potential public health emergency involving COVID-19..

 

The pending Emergency Use Authorization, or EUA, for Niyad is based uponOn May 11, 2023, the U.S. government’s declaration of a nationalCOVID-19 public health emergency, due toor PHE, declared under the COVID-19 pandemic. InPublic Health Service, or PHS, Act expired. Under Section 564 of the event thatFederal Food, Drug, and Cosmetic, or FD&C, Act, the national health emergency ceases to exist though action or proclamation byCommissioner of the FDA, acting under delegated authority from the Secretary of U.S. Department of Health and Human Services, or HHS, allmay issue an Emergency Use Authorization, or EUA, applications based uponauthorizing (1) the emergency use of an unapproved drug, an unapproved or uncleared device, an unlicensed biological product, or an unapproved animal drug; or (2) an unapproved use of an approved drug, approved or cleared device, licensed biological product, or conditionally approved animal drug. The ending of the PHE declared by the HHS under the PHS Act will not impact the FDA’s ability to authorize devices, treatments or vaccines for emergency use as long as the EUA declaration related to COVID-19 emergency, including our applicationissued pursuant to Section 564 of the FD&C Act is still in effect. Existing EUAs for products will remain in effect and the agency may continue to issue new EUAs going forward when criteria for issuance are met until such time as the HHS COVID-19 EUA declaration under Section 564 is terminated. On March 15, 2023, the Secretary of the HHS determined that there is still a “significant potential for a public health emergency” involving SARS-CoV-2 under Section 564. Our EUA submission that is currently under review by FDA for Niyad will become moot.is premised on this significant potential public health emergency involving COVID-19. Although the FDA maintains the discretion to keep EUAs in effect and to continue to issue new EUAs, the expiration of the declared PHE under the PHS Act may negatively impact our prospects for obtaining authorization in the first place, and even if authorized, any sales for a COVID-related indication may be limited and distract us from the goal of obtaining Premarket Approval, or PMA, for Niyad.

 

Risks Related to Drug Development and Commercialization

 

We may fail to realize the benefits expected from our acquisition of Lowell, which could adversely affect our stock price.

Our successacquisition of Lowell is highly dependentour largest acquisition to date. Our primary business strategy is focused on developing, obtaining approval, and commercializing our product candidates, including Niyad and LTX-608 that we acquired from Lowell. The anticipated benefits we expect from this acquisition are, necessarily, based on projections and assumptions about the combined businesses of our company and Lowell, which may not materialize as expected or which may prove to be inaccurate. The value of our common stock could be adversely affected if we are unable to realize the anticipated benefits from the acquisition on a timely basis or at all. Achieving the benefits of the acquisition of Lowell will depend, in part, on our ability to continue integrate the business, operations and products of Lowell successfully and efficiently with our business. The challenges involved in this integration include, but are not limited to, (i) difficulties entering new markets and integrating new product candidates with which we have no or limited direct prior experience; and (ii) successfully managing relationships with our combined supplier base.

Our failure to identify or accurately assess the magnitude of certain liabilities we assumed in the acquisition could result in unexpected litigation or regulatory exposure, unfavorable accounting charges, unexpected increases in taxes due, a potential partnerloss of anticipated tax benefits or other adverse effects on our business, operating results or financial condition.

sWhether we receive royalties from DSUVIA is dependent on the ability of Alora to successfully commercialize DSUVIA. If Alora is unable to successfully commercialize DSUVIA, our business, financial condition, and results of operations will be materially harmed.

 

We have invested a significant portion of our efforts and financial resourcesdivested DSUVIA to develop and gain regulatory approval for DSUVIA and expect toAlora, who will continue making significant investments, or agree with a potential commercial partner, to commercialize DSUVIA. We believe our success is highly dependentthe product and we will receive royalties and milestone payments based on and a significant portion of the value of our company relates to, our ability, or a potential partners’ ability, to successfully commercialize DSUVIA in the United States.their sales. The commercial success of DSUVIA dependswill depend heavily on numerous factors, including:

 

 

our ability to identify and secure potential strategic partnerships with a third party having sufficient commercial resources to maintain and potentially expand DSUVIA commercial sales;

our, or a potential partner’sAlora’s ability to market, sell, and distribute DSUVIA;

 

our, or a potential partner’s ability to maintain or grow DSUVIA commercial sales with a reduced salesforce;

our, or a potential partner’sAlora’s ability to establish and maintain commercial manufacturing relationships with our third partythird-party service providers;

 

acceptance by the medical community, including physicians, nurses, patients and pharmacy and therapeutics committees;

 

acceptance of pricing and placement on payers’ formularies;

 

ourAlora’s ability or a potential partner’s to effectively compete with other medications for the treatment of moderate-to-severe acute pain in medically supervised settings, including IV-opioids and any subsequently approved products;

 

effective management of, and compliance with, the DSUVIA Risk Evaluation and Mitigation Strategy, or REMS, program;

 

continued demonstration of an acceptable safety profile of DSUVIA; and

 

ourAlora’s ability or a potential partner’s to obtain, maintain, enforce, and defend ourthe intellectual property rights and claims.claims for DSUVIA.

 

34

If we, or a potential partner, areAlora is unable to successfully commercialize DSUVIA, our business, financial condition, and results of operations will be materially harmed. We believe that the uptake of DSUVIA will be maximized through a partner with a larger commercial infrastructure and, as such, we are in discussions with potential partners that can execute a more robust commercial plan to support DSUVIA sales expansion, while further reducing our operating costs. The ultimate structure of a potential transaction with a third party may take multiple forms and is not known at this time.

43

 

The commercial success of DSUVIADelays in clinical trials are common and if approved,have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product candidates in the United States, as well as DZUVEO in Europe, will depend upon the acceptance of these products by the medical community, including physicians, nurses, patients, and pharmacy and therapeutics committees.sales.

 

The degreeWe have experienced and may in the future experience delays in clinical trials of market acceptance of DSUVIA and, if approved,our product candidates. Our FDA-required clinical trials for our product candidates, in the United States, as well as DZUVEO in Europe, by the medical community will depend oncould be delayed for a numbervariety of factors,reasons, including:

 

 

demonstration of clinical safety and efficacy comparedinability to other products;raise funding necessary to initiate or continue a trial;

the relative convenience, ease of administration and acceptance by physicians, patients and health care payers;

the use of our approved products by a healthcare professional for patient types that were not specifically studied in clinical trials;

the prevalence and severity of any adverse events, or AEs, or serious adverse events, or SAEs;

overcoming any perceptions of sufentanil as a potentially unsafe drug due to its high potency opioid status;

limitations or warnings contained in the U.S. Food and Drug Administration, or FDA, -approved label for DSUVIA and, if approved, our product candidates, or the European Medicines Agency, or EMA, -approved label for DZUVEO;

restrictions or limitations placed on DSUVIA due to the REMS program or, if approved, on our product candidates;

availability of alternative treatments;

existing capital investment by hospitals in IV PCA technology;

pricing and cost-effectiveness;

the effectiveness of our current or any future collaborators’ sales and marketing strategies;

our ability to obtain formulary approvals; and

our ability to obtain and maintain sufficient third-party coverage and reimbursement.

If our approved products do not achieve an adequate level of acceptance by the medical community, including physicians, nurses, patients and pharmacy and therapeutics committees, we may not generate sufficient revenue and become or remain profitable.

If we are unable to maintain or grow our sales and marketing capabilities or enter into agreements with third parties to market and sell our products and, if approved, our product candidates, we may be unable to generate sufficient product revenue.

In order to commercialize DSUVIA and, if approved, our product candidates in the United States, we must maintain or grow internal sales, marketing, distribution, managerial and other capabilities or make arrangements with third parties to perform these services. We have entered into agreements with third parties for the distribution of DSUVIA and may enter into such agreements for our product candidates, if approved, in the United States, including the product candidates we in-licensed from Laboratoire Aguettant, or Aguettant, in July 2021 pursuant to a License and Commercialization Agreement, or the PFS Agreement, and the product candidates we acquired through our acquisition of Lowell; however, if these third parties do not perform as expected or there are delays in establishing such relationships, our ability to effectively distribute products would suffer.

We have entered into strategic partnerships with third parties to commercialize our products outside of the United States. In July 2021, we entered a License and Commercialization Agreement, or the DZUVEO Agreement, with Aguettant for the commercialization of DZUVEO in the European Union, Norway, Iceland, Liechtenstein, Andorra, Vatican City, Monaco, Switzerland and the United Kingdom, or the DZUVEO Territory. We intend to enter into additional strategic partnerships with third parties to commercialize our products outside of the United States.

We face significant competition in seeking appropriate strategic partners, and these strategic partnerships can be intricate and time consuming to negotiate and secure. We may not be able to negotiate future strategic partnerships on acceptable terms, or at all. For example, in 2013 we entered into a collaboration with Grünenthal GmbH, or Grünenthal, for the commercialization of Zalviso® in Europe and Australia. Grünenthal ceased commercializing Zalviso on May 12, 2021 and the rights to market and sell Zalviso reverted back to us. The European Marketing Authorization for Zalviso was withdrawn in July 2022. We are unable to predict when, if ever, we will enter into any new strategic partnerships because of the numerous risks and uncertainties associated with establishing strategic partnerships. Our current or future collaboration partners, if any, may not dedicate sufficient resources to the commercialization of our products and product candidates, if approved, or may otherwise fail in their commercialization due to factors beyond our control. If we are unable to establish effective collaborations to enable the sale of our products to healthcare professionals and in geographical regions that will not be covered by our own marketing and sales force, or if our potential future collaboration partners do not successfully commercialize our products, our ability to generate revenues from product sales will be adversely affected.

If we are unable to maintain or grow adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue and become profitable. We compete with many companies that currently have extensive and well-funded marketing and sales operations. Without an internal team or the support of a third party to perform marketing and sales functions, we may be unable to compete successfully against these more established companies.

44

A key part of our business strategy is to establish collaborative relationships to commercialize and fund development and approval of our products, particularly outside of the United States. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our products successfully, if at all.

We will need to establish and maintain successful collaborative relationships to obtain international sales, marketing and distribution capabilities for our products. The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty. For example:

 

 

our partners may seekinability to renegotiate or terminate their relationships with us due to unsatisfactory clinical or regulatory results, manufacturing issues, a change in business strategy, a change of control or other reasons;pay significant FDA filing fees;

our contracts for collaborative arrangements are or may be terminable at will on written notice and may otherwise expire or terminate, and we may not have alternatives available to achieve the potential for our products in those territories or markets;

our partners may choose to pursue alternative technologies, including those of our competitors;

we may have disputes with a partner that could lead to litigation or arbitration, including in connection with any contractual force majeure notices tied to the COVID-19 pandemic;

we have limited control over the decisions of our partners, and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delays to the partnered program;

our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drugs, maintain regulatory approvals and our ability to successfully manufacture and achieve market acceptance of our products;

we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability;

our partners may not devote sufficient capital or resources towards our products; and

our partners may not comply with applicable government regulatory requirements necessary to successfully market and sell our products.

If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, any research, clinical development, manufacturing or commercialization efforts pursuant to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or activities that would otherwise have been the responsibility of our collaborator. If we are unable to establish and maintain collaborative relationships on acceptable terms we may have to undertake development and commercialization activities at our own expense.

We may experience difficulties in retaining our existing employees and managing our operations, including our continued commercialization of DSUVIA.

We need to retain and maintain our existing sales, managerial, operational, finance and other personnel and resources in order to continue the commercialization of DSUVIA and manage our operations. Our current infrastructure may be inadequate to support our strategy and any future workforce reduction, such as the reduction that eliminated approximately 40% of our workforce in May 2022 and subsequent related workforce reductions, may be disruptive to our operations, may negatively affect our productivity, and may constrain our commercialization activities. For example, a further workforce reduction could yield unanticipated consequences, such as attrition beyond planned staff reductions, negatively impacting employee morale and our corporate culture, or increased difficulties in our day-to-day operations, and prevent us from successfully commercializing DSUVIA as rapidly as planned. If we encounter such unanticipated consequences, we may have difficulty retaining and attracting personnel. In addition, the implementation of any additional workforce or expense reduction programs may divert the efforts of our management team and other key employees, which could adversely affect our business. Furthermore, we may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our cost reduction plan, due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the cost reduction plan, our operating results and financial condition would be adversely affected.

45

Guidelines and recommendations published by government agencies, as well as non-governmental organizations, and existing laws and regulations can reduce the use of DSUVIA in the United States.

Government agencies and non-governmental organizations promulgate regulations and guidelines applicable to certain drug classes that may include DSUVIA in the United States. Recommendations of government agencies or non-governmental organizations may relate to such matters as maximum quantities dispensed to patients, dosage, route of administration, and use of concomitant therapies. Government agencies and non-governmental organizations have offered commentary and guidelines on the use of opioid-containing products. We are uncertain how these activities and guidelines may impact DSUVIA in the United States. Regulations or guidelines suggesting the reduced use of certain drug classes that may include DSUVIA, or the use of competitive or alternative products as the standard-of-care to be followed by patients and healthcare providers, could result in decreased use of DSUVIA, or negatively impact our ability to gain market acceptance and market share. The U.S. government and state legislatures have prioritized combatting the growing misuse and addiction to opioids and opioid overdose deaths and have enacted legislation and regulations as well as other measures intended to fight the opioid epidemic. Addressing opioid drug abuse is a priority for the current U.S. administration and the FDA and is part of a broader initiative led by the U.S. Department of Health and Human Services, or HHS. Overall, there is greater scrutiny of entities involved in the manufacture, sale and distribution of opioids. These initiatives, existing laws and regulations, and any negative publicity related to opioids may have a material impact on our business and our ability to manufacture opioid products.

Governmental investigations, inquiries, and regulatory actions and lawsuits brought against us by government agencies and private parties with respect to our commercialization of opioids could adversely affect our business, financial condition, results of operations and cash flows.

As a result of greater public awareness of the public health issue of opioid abuse, there has been increased scrutiny of, and investigation into, the commercial practices of opioid manufacturers by state and federal agencies. As a result of our manufacturing and commercial sale of DSUVIA in the United States, and DZUVEO in Europe, we could become the subject of federal, state and foreign government investigations and enforcement actions, focused on the misuse and abuse of opioid medications.

In addition, a significant number of lawsuits have been filed against opioid manufacturers, distributors, and others in the supply chain by cities, counties, state Attorney’s General and private persons seeking to hold them accountable for opioid misuse and abuse. The lawsuits assert a variety of claims, including, but not limited to, public nuisance, negligence, civil conspiracy, fraud, violations of the Racketeer Influenced and Corrupt Organizations Act, or RICO, or similar state laws, violations of state Controlled Substance Acts or state False Claims Acts, product liability, consumer fraud, unfair or deceptive trade practices, false advertising, insurance fraud, unjust enrichment and other common law and statutory claims arising from defendants’ manufacturing, distribution, marketing and promotion of opioids and seek restitution, damages, injunctive and other relief and attorneys’ fees and costs. The claims generally are based on alleged misrepresentations and/or omissions in connection with the sale and marketing of prescription opioid medications and/or an alleged failure to take adequate steps to prevent abuse and diversion. While DSUVIA is designed for use solely in certified medically supervised healthcare settings and administered only by a healthcare professional in these settings, and is not distributed or available at retail pharmacies to patients by prescription, we can provide no assurance that parties will not file lawsuits of this type against us in the future. In addition, current public perceptions of the public health issue of opioid abuse may present challenges to favorable resolution of any potential claims. Accordingly, we cannot predict whether we may become subject to these kinds of investigations and lawsuits in the future, and if we were to be named as a defendant in such actions, we cannot predict the ultimate outcome. Any allegations against us may negatively affect our business in various ways, including through harm to our reputation.

If we were required to defend ourselves in these matters, we would likely incur significant legal costs and could in the future be required to pay significant amounts as a result of fines, penalties, settlements or judgments. It is unlikely that our current product liability insurance would fully cover these potential liabilities, if at all. Moreover, we may be unable to maintain insurance in the future on acceptable terms or with adequate coverage against potential liabilities or other losses. For more information about our product liability insurance and exclusions therefrom, please see the risk factor entitled “We face potential product liability claims, and, if such claims are successful, we may incur substantial liability” elsewhere in this section. The resolution of one or more of these matters could have a material adverse effect on our business, financial condition, results of operations and cash flows.

Furthermore, in the current climate, stories regarding prescription drug abuse and the diversion of opioids and other controlled substances are frequently in the media or advocated by public interest groups. Unfavorable publicity regarding the use or misuse of opioid drugs, the limitations of abuse-deterrent formulations, the ability of drug abusers to discover previously unknown ways to abuse opioid products, public inquiries and investigations into prescription drug abuse, litigation, or regulatory activity regarding sales, marketing, distribution or storage of opioids could have a material adverse effect on our reputation and impact on the results of litigation.

Finally, various government entities, including Congress, state legislatures or other policy-making bodies, or public interest groups have in the past and may in the future hold hearings, conduct investigations and/or issue reports calling attention to the opioid crisis, and may mention or criticize the perceived role of manufacturers, including us, in the opioid crisis. Similarly, press organizations have and likely will continue to report on these issues, and such reporting may result in adverse publicity for us, resulting in reputational harm.

46

Approval of DZUVEO in Europe has resulted in a variety of risks associated with international operations that could materially adversely affect our business.

Our collaborations with international partners, including Aguettant, requires us to supply product to support the commercialization of our products in Europe and it is likely that any new international collaborations would also include such a requirement. Entering into international business relationships subjects us to additional risks including:

 

 

multiple, conflicting, and changing laws and regulations such as privacy and data regulations, transparency regulations, tax laws, export and import restrictions, employment laws,delays in obtaining regulatory requirements, including for drug approvals, and other governmental approvals, permits, and licenses;approval to commence a trial;

 

EMA “sunset clause” requirements, which apply to DZUVEO, providing thatdelays in reaching agreement with the marketing authorization of a medicine will cease to be valid if it is not placedFDA on the market within three years of the authorization being granted or if it is removed from the market for three consecutive years; however, the European Commission has extended this date to December 31, 2022 for DZUVEO;final trial design;

 

our reliance on multiple third-party manufacturing partners to supply Aguettant with DZUVEO product for commercialization in Europe in accordance with our contractual obligations;imposition of a clinical hold by the FDA, Institutional Review Board, or IRB, or other regulatory authorities;

 

reduced protection for intellectual property rights;delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;

 

unexpected changesdelays in tariffs, trade barriers and regulatory requirements;obtaining required IRB approval at each site;

 

different payer reimbursement regimes, governmental payers, patient self-pay systems and price controls;delays in recruiting suitable patients or subjects to participate in a trial;

 

economic weakness, including inflation,delays in having patients complete participation in a trial or political instability in particular foreign economies and markets;return for post-treatment follow-up;

 

production shortages resulting from any events affecting raw material supplyclinical sites dropping out of a trial to the detriment of enrollment or manufacturing capabilities abroad; andbeing delayed in entering data to allow for clinical trial database closure;

 

business interruptions resulting from pandemics, geopolitical actions, including wartime required to add new clinical sites;

delays by our contract manufacturers to produce and terrorism,deliver sufficient supply of clinical trial materials; or natural disasters including earthquakes, typhoons, floods and fires.

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate.

 

AnyIf any future FDA-required clinical trials are delayed for any reason, our development costs may increase, our approval process for our product candidates could be delayed, our ability to commercialize and commence sales of these factorsour product candidates could be materially harmed, which could have a material adverse effect on our business.

 

Our drug discovery and development efforts might not generate successful product candidates.

We plan to invest a significant portion of our efforts and financial resources in the identification or asset acquisition of our product candidates, Niyad, LTX-608 and the pre-filled syringes. Our ability to generate product revenue from these product candidates, which may not occur for many years, if ever, will depend heavily on the successful development and eventual commercialization of Niyad, LTX-608 and the pre-filled syringes. The success of these product candidates and any other product candidates we may develop will depend on many factors, including the following:

successful enrollment in, and completion of, clinical trials;

demonstrating safety and efficacy;

receipt of marketing approvals from applicable regulatory authorities;

establishing commercial manufacturing capabilities or making arrangements with third-party manufacturers;

obtaining and maintaining patent and trade secret protection and non-patent exclusivity for our product candidates;

developing a sales and marketing organization or outsourcing these functions to third parties;

launching commercial sales of the product candidates, if and when approved, whether alone or selectively in collaboration with others;

35

acceptance of the product candidates, if and when approved, by patients, the medical community and third-party payors;

effectively competing with other products;

a continued acceptable safety profile of the products following approval;

enforcing and defending intellectual property rights and claims; and

other legal, regulatory, compliance, privacy, and fraud and abuse matters.

If we do not accomplish one or currentmore of these goals in a timely manner, or at all, we could experience significant delays or an inability to successfully commercialize our product candidates, which would harm our business.

If clinical trials of our product candidates fail to demonstrate safety and potential partners,efficacy to the satisfaction of regulatory authorities or do not otherwise produce positive results, we may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates.

Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we must conduct extensive clinical trials to demonstrate the safety and efficacy of our product candidates in humans. Clinical testing is expensive, difficult to design and implement, can take many years to complete and is uncertain as to outcome. A failure of one or more clinical trials could occur at any stage of testing. The outcome of early clinical trials may not be predictive of the success of later clinical trials, and interim results of a particular clinical trial do not necessarily predict final results of that trial.

Moreover, clinical data is often susceptible to multiple interpretations and analyses. Many companies that have believed their product candidates performed satisfactorily in preclinical studies and clinical trials have nonetheless failed to obtain marketing approval of their products.

We may experience numerous unforeseen events during, or as a result of, clinical trials that could delay or prevent our ability to receive marketing approval or commercialize our product candidates, including that:

regulators or institutional review boards may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site;

we may have delays in reaching or fail to reach agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites;

clinical trials of our product candidates may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional clinical trials or abandon product development programs;

the number of patients required for clinical trials of our product candidates may be larger than we anticipate; enrollment in these clinical trials may be slower than we anticipate, or participants may drop out of these clinical trials at a higher rate than we anticipate;

our third-party contractors may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all;

regulators or institutional review boards may require that we or our investigators suspend or terminate clinical research for various reasons, including noncompliance with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;

the cost of clinical trials of our product candidates may be greater than we anticipate; and

the supply or quality of our product candidates or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate.

If we are required to conduct additional clinical trials or other testing of our product candidates beyond those that we currently contemplate, if we are unable to compete effectively, our products may not reach their commercial potential.

The U.S. biotechnology and pharmaceutical industries are characterized by intense competition and cost pressure. DSUVIA competes, andsuccessfully complete clinical trials of our product candidates or other testing, if approved in the U.S., will compete, with a numberresults of existing and future pharmaceuticals and drug delivery devices developed, manufactured and marketed by others. In particular, DSUVIA may compete with a wide variety of products and product candidates including (i) injectable opioid products, such as morphine, fentanyl, hydromorphone and meperidine; (ii) oral opioids such as oxycodone and hydrocodone; (iii) generic injectable local anesthetics, such as bupivacainethese trials or branded formulations thereof; (iv) non-steroidal anti-inflammatory drugs,tests are not positive or NSAIDS, including ketorolac in intranasalare only modestly positive or generic IV form, and IV meloxicam; and (v) transmucosal fentanyl products. The PFS product candidates, if approved in the U.S., may compete with other ready-to-use formulations of ephedrine and phenylephrine. The nafamostat product candidates, if approved in the U.S., may compete with heparin and citrate.there are safety concerns, we may:

 

be delayed in obtaining marketing approval for our product candidates;

Key competitive factors affecting the commercial success of our approved products are likely to be efficacy, safety profile, reliability, convenience of dosing, price and reimbursement. Many of our competitors and potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approval of products, and the commercialization of those products. Accordingly, our competitors may be more successful than we are in obtaining FDA approval for drugs and achieving widespread market acceptance. Our competitors’ drugs or drug delivery systems may be more effective, have fewer adverse effects, be less expensive to develop and manufacture, or be more effectively marketed and sold than any product we may seek to commercialize. This may render our products obsolete or non-competitive. We anticipate that we will face intense and increasing competition as new drugs enter the market, additional technologies become available, and competitors establish collaborative or licensing relationships, which may adversely affect our competitive position. These and other competitive risks may materially adversely affect our ability to attain or sustain profitable operations.

not obtain marketing approval at all;

obtain approval for indications or patient populations that are not as broad as intended or desired;

obtain approval with labeling that includes significant use or distribution restrictions or safety warnings, including boxed warnings;

be subject to additional post-marketing testing requirements; or

have the product removed from the market after obtaining marketing approval.

 

4736

 

Product development costs will also increase if we experience delays in testing or in receiving marketing approvals. We do not know whether any clinical trials will begin as planned, will need to be restructured or will be completed on schedule, or at all. Significant clinical trial delays also could shorten any periods during which we may have the exclusive right to commercialize our product candidates, could allow our competitors to bring products to market before we do, and could impair our ability to successfully commercialize our product candidates, any of which may harm our business and results of operations.

HospitalIf we experience delays or other health care facility formularydifficulties in enrolling patients in clinical trials, our receipt of necessary regulatory approvals could be delayed or prevented.

We may not be able to initiate or continue clinical trials for DSUVIA or our product candidates if approved,we are unable to identify and enroll a sufficient number of eligible patients to participate in these trials as required by the U.S. Food and Drug Administration, or the FDA, or analogous regulatory authorities outside the United StatesStates. In addition, some of our competitors may nothave ongoing clinical trials for product candidates that would treat the same indications as our product candidates, and patients who would otherwise be achieved,eligible for our clinical trials may instead enroll in clinical trials of our competitors’ product candidates. Patient enrollment is also affected by other factors, including:

severity of the disease under investigation;

availability and efficacy of approved medications for the disease under investigation;

eligibility criteria for the trial in question;

perceived risks and benefits of the product candidate under study;

efforts to facilitate timely enrollment in clinical trials;

patient referral practices of health care professionals;

the ability to monitor patients adequately during and after treatment; and

proximity and availability of clinical trial sites for prospective patients.

Our inability to enroll enough patients for our clinical trials would result in significant delays or could be subject to certain restrictions, which could make it difficult formay require us to sellabandon one or more clinical trials altogether. Enrollment delays in our products.clinical trials may result in increased development costs for our product candidates, which would cause the value of our company to decline and limit our ability to obtain additional financing.

If serious adverse effects or unexpected characteristics of our product candidates are identified during development, we may need to abandon or limit our development of some or all of our product candidates.

 

Obtaining hospitalIt is impossible to predict when or other health care facility formulary approvals can be an expensive and time-consuming process. We cannot be certain if and when we will obtain formulary approvals to allow us to sell our products into our target markets. In particular, the COVID-19-related restrictions on our commercial and medical affairs teams’ access to hospitals and other health care facilities has adversely impacted the numberany of formulary approvals we achieved to date, and for as long as these restrictions remain in place, or new restrictions are implemented, we may have limited visibility or difficulties in obtaining these formulary approvals. Failure to obtain timely formulary approvals will limit our commercial success. In order to obtain formulary approvals, we often are required to complete evaluation programs whereby DSUVIA, or our product candidates if approved, are used on a limited basis for certain patient types. The evaluation period may last several months and there can be no assurance that use during the evaluation period will lead to formulary approvalsprove effective or safe in humans or will receive marketing approval. Adverse events or undesirable side effects caused by, or other unexpected properties of, DSUVIA, or our product candidates if approved. Further, even successful formulary approvals are subjectcould cause us, any current or future collaborators, an institutional review board or regulatory authorities to certain restrictions based on patient typeinterrupt, delay or hospital protocol. Failure to obtain timely formulary approvals for DSUVIA,halt clinical trials of one or more of our product candidates if approved, would materiallyand could result in a more restrictive label, or the delay or denial of marketing approval by the FDA or comparable foreign regulatory authorities. If adverse effects were to arise in patients being treated with any of our product candidates, it could require us to halt, delay or interrupt clinical trials of such product candidate or adversely affect our ability to attainobtain requisite approvals to advance the development and commercialization of such product candidate. If our product candidates are associated with undesirable side effects or sustain profitable operations.have characteristics that are unexpected, we may need to abandon their development or limit development to certain uses or subpopulations in which the undesirable side effects or other characteristics are less prevalent, less severe or more acceptable from a risk-benefit perspective.

 

CoverageWe may expend our limited resources to pursue a particular product candidate or indication and adequate reimbursement may not be available for DSUVIA or ourfail to capitalize on product candidates if approved, in the United States, or DZUVEO in Europe,indications that may be more profitable or for which could make it difficult for us, or our partners, to sell our products profitably. there is a greater likelihood of success.

 

Our ability to commercialize DSUVIA or our product candidates, if approved, in the United States,We have limited financial and Aguettant’s ability to commercialize DZUVEO in Europe successfully will depend, in part, on the extent to which coverage and adequate reimbursement will be available from government payer programs at the federal and state levels, authorities, including Medicare and Medicaid, private health insurers, managed care plans and other third-party payers.

No uniform policy requirement for coverage and reimbursement for drug products exists among third-party payers in the United States or Europe. Therefore, coverage and reimbursement can differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will require us to provide scientific and clinical support for the use of our products to each payer separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such products. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact utilization. Our inability to promptly obtain and sufficiently maintain coverage and adequate reimbursement rates from third party payers could significantly harm our operating results, our ability to raise capital needed to commercialize our approved drugs and our overall financial condition.

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payers have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products. There have been a number of legislative and regulatory proposals to change the healthcare system in the United States and in some foreign jurisdictions that could affect our ability to sell our products profitably. These legislative and/or regulatory changes may negatively impact the reimbursement for our products, following approval. The availability of numerous generic pain medications may also substantially reduce the likelihood of reimbursement for DSUVIA in the United States, and DZUVEO in Europe and elsewhere. The application of user fees to generic drug products may expedite the approval of additional pain medication generic drugs. We expect to experience pricing pressures in connection with our sales of DSUVIA in the United States, and product sales of DZUVEO by Aguettant in Europe, due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. If we fail to successfully secure and maintain reimbursement coverage for our products or are significantly delayed in doing so, we will have difficulty achieving market acceptance of our products and our business will be harmed.

Furthermore, market acceptance and sales of our products will depend on reimbursement policies and may be affected by future healthcare reform measures. Government authorities and third-party payers, such as private health insurers, hospitals and health maintenance organizations, decide which drugs they will pay for and establish reimbursement levels. We cannot be sure that reimbursement will be available for DSUVIA or our product candidates, if approved, in the United States, or DZUVEO in Europe. Also, reimbursement amounts may reduce the demand for, or the price of, our products. For example, studies of DZUVEO in Europe may be needed to ensure premium reimbursement in certain countries. If reimbursement is not available, or is available only to limited levels, we may not be able to successfully commercialize DSUVIA or our product candidates, if approved, in the United States, or DZUVEO in Europe.

Additionally, the regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted.managerial resources. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations thatmay forego or delay commercial launchpursuit of the product, possibly for lengthy time periods, and negatively impact the revenues able to be generated from the sale of the product in that country. For example, separate pricing and reimbursement approvals may impact Aguettant’s ability to market and successfully commercialize DZUVEO in the 27 member states of the European Union. Adverse pricing limitations may hinder our ability to recoup our investment in DSUVIA in the United States, or ouropportunities with other product candidates even after obtaining FDA marketing approval.or for other indications that later prove to have greater commercial potential. Our resource allocation decisions may cause us to fail to capitalize on viable commercial products or profitable market opportunities. Our spending on current and future research and development programs and product candidates for specific indications may not yield any commercially viable products. If we do not accurately evaluate the commercial potential or target market for a particular product candidate, we may relinquish valuable rights to that product candidate through collaboration, licensing or other royalty arrangements.

 

4837

 

The FDAprocess for obtaining approval of a PMA or NDA is time consuming, subject to unanticipated delays and other regulatory agencies actively enforcecosts, and requires the laws and regulations prohibiting the promotioncommitment of off-label uses.substantial resources.

 

If we are found to have improperly promoted off-label uses of our products, including DSUVIA or our product candidates, if approved, in the United States, we may become subject to significant liability. Such enforcement has become more common in the industry. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription drug products. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. While we have received marketing approval for DSUVIA for our proposed indication, physicians may nevertheless use our products for their patients in a manner that is inconsistent with the approved label, if the physicians personally believe in their professional medical judgment it could be used in such manner. However, if the FDA determines that our promotional materials or training constitutes promotionany of an off-label use, it could request that we modify our training or promotional materials or subject us to regulatory or enforcement actions,the clinical work submitted, including the issuanceclinical trials, Human Factors studies and bench testing submitted for a product candidate in support of an untitled letter, a Warning Letter, injunction, seizure, civil finepremarket approval application (PMA) or criminal penaltiesNDA were not conducted in full compliance with the applicable protocols for these trials, studies and a requirement for corrective advertising, including Dear Doctor letters. It is also possible that other federal, statetesting as well as with applicable regulations and standards, or foreign enforcement authorities might take action if they considerthe FDA does not agree with our promotionalinterpretation of the results of such trials, studies and testing, the FDA may reject the data and results. The FDA may audit some or training materials to constitute promotion of an off-label use, which could result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, increased losses and diminished profits and the curtailment or restructuringall of our operations,clinical trial sites to determine the integrity of our clinical data. The FDA may audit some or all of our study sites to determine the integrity of our data and may audit the data and results of bench testing. Any rejection of any of which could adversely affectour data would negatively impact our ability to operate our business and our financial results. The FDA or other enforcement authorities could also request that we enter into a consent decree or a corporate integrity agreement or seek a permanent injunction against us under which specified promotional conduct is monitored, changed or curtailed. If we cannot successfully manage the promotion of DSUVIA orobtain marketing authorization for our product candidates if approved, in the United States, we could become subject to significant liability, whichand would materially adversely affect our business and financial condition.

If we are unable to establish and maintain relationships with group purchasing organizations any future revenues or future profitability could be jeopardized.

Many end-users of pharmaceutical products have relationships with group purchasing organizations, or GPOs, whereby such GPOs provide such end-users access to a broad range of pharmaceutical products from multiple suppliers at competitive prices and, in certain cases, exercise considerable influence over the drug purchasing decisions of such end-users. Hospitals and other end-users contract with the GPO of their choice for their purchasing needs. We expect to derive revenue from end-user customers that are members of GPOs for DSUVIA and our product candidates, if approved. Establishing and maintaining strong relationships with these GPOs will require us to be a reliable supplier, remain price competitive and comply with FDA regulations. The GPOs with whom we have relationships may have relationships with manufacturers that sell competing products, and such GPOs may earn higher margins from these products or combinations of competing products or may prefer products other than ours for other reasons. If we are unable to establish or maintain our GPO relationships, sales of DSUVIA and our product candidates, if approved, and related revenues could be negatively impacted.

We intend to rely on a limited number of distributors and pharmaceutical wholesalers to distribute DSUVIA and our product candidates, if approved, in the United States.

We intend to rely primarily upon distributors and pharmaceutical wholesalers in connection with the distribution of DSUVIA and our product candidates, if approved, in the United States. As part of the DSUVIA REMS program, we monitor distribution and audit wholesalers’ data and will monitor such data from other distributors. If our distributors and wholesalers do not comply with the DSUVIA REMS requirements, or if we are unable to establish or maintain our business relationships with these distributors and pharmaceutical wholesalers on commercially acceptable terms, or if our distributors and wholesalers are unable to distribute our drugs for regulatory, compliance or any other reason, it could have a material adverse effect on our salesbusiness and financial condition. In addition, an NDA or PMA may not be approved, or approval may be delayed, as a result of changes in FDA policies for drug or device approval during the review period. For example, although many products have been approved by the FDA in recent years under Section 505(b)(2) of the FDCA, objections have been raised to the FDA’s interpretation of Section 505(b)(2). If challenges to the FDA’s interpretation of Section 505(b) (2) are successful, the FDA may be required to change its interpretation, which could delay or prevent the approval of such an NDA. Any significant delay in the acceptance, review or approval of an NDA or PMA that we have submitted would have a material adverse effect on our business and financial condition and would require us from achieving profitability.

Risks Related to Clinical Development and Regulatory Approvalobtain significant additional funding.

 

Our expectations for FDA approvability of our product candidates may be inaccurate, and we may be required to conduct additional manufacturing, nonclinical or clinical development work in order to obtain FDA approval for these products, which would add to our expenses and delay any associated revenue.

 

On July 14, 2021, we entered into the PFS Agreement with Aguettant pursuant to which we obtained the exclusive right to develop and, subject to FDA approval, commercialize in the United States (i) an ephedrine pre-filled syringe containing 10 ml of a solution of 3 mg/ml ephedrine hydrochloride for injection, and (ii) a phenylephrine pre-filled syringe containing 10 ml of a solution of 50 mcg/ml phenylephrine for injection. Aguettant will supply us with the products for use in commercialization, if they are approved in the U.S. Our current expectation based on our communication with the FDA is that Fedsyra™, the PFS ephedrine product candidate, will be approvable by the FDA without additional manufacturing changes or clinical development. We have not yet received all the available data to support the planned NDA filingsubmission for the PFS phenylephrine product. If we or the FDA determine that additional development work will be needed for U.S. approval of either of the PFS product candidates, we would incur additional expense and be delayed in obtaining any revenue from that product.

49

 

Nafamostat is being developed for both medical device and drug indications for use. Although nafamostat is approved for certain uses in Japan, our ability to leverage that for an expedited development and approval pathway with the FDA may be limited, and we may be required to conduct additional unanticipated nonclinical studies and clinical trials in order to seek approval in the U.S. We plan to study Niyad™ under an investigational device exemption, or IDE.IDE and although we have submitted an IDE to FDA, it remains under review. Niyad has received Breakthrough Device Designation from the FDA for regional anticoagulant for injection into the extracorporeal circuit and is expected to be used during renal replacement therapy for acute kidney injury patients in the hospital and for end-stage renal disease patients receiving dialysis in outpatient clinics. We expect that Niyad will require filingapproval of a Premarket Approval, or PMA, application. In addition,application for commercialization in the Breakthrough Designation allowsU.S., and as a company we have never submitted nor received approval for more frequent and informal FDA communication regarding development plans and allows for priority review once the marketing application is submitted.a PMA.

 

The active drug component of Niyad, nafamostat, is also being developed for drug indications as LTX-608, for which we expect to submit Investigational New Drug applications.applications once IND-enabling studies have been completed. We may be delayed in the submission of our planned INDs if there are unexpected findings in our nonclinical studies.

38

A key part of our business strategy is to establish collaborative relationships to commercialize and fund development and approval of our products, particularly outside of the United States. We may not succeed in establishing and maintaining collaborative relationships, which may significantly limit our ability to develop and commercialize our products successfully, if at all.

We will need to establish and maintain successful collaborative relationships to obtain international sales, marketing and distribution capabilities for our products. The process of establishing and maintaining collaborative relationships is difficult, time-consuming and involves significant uncertainty. For example:

our partners may seek to renegotiate or terminate their relationships with us due to unsatisfactory clinical or regulatory results, manufacturing issues, a change in business strategy, a change of control or other reasons;

our contracts for collaborative arrangements are or may be terminable at will on written notice and may otherwise expire or terminate, and we may not have alternatives available to achieve the potential for our products in those territories or markets;

our partners may choose to pursue alternative technologies, including those of our competitors;

we may have disputes with a partner that could lead to litigation or arbitration, including in connection with any contractual breach notice including force majeure tied to the COVID-19 pandemic;

we have limited control over the decisions of our partners, and they may change the priority of our programs in a manner that would result in termination of the agreement or add significant delays to the partnered program;

our ability to generate future payments and royalties from our partners depends upon the abilities of our partners to establish the safety and efficacy of our drugs and devices, maintain regulatory approvals and our ability to successfully manufacture and achieve market acceptance of our products;

we or our partners may fail to properly initiate, maintain or defend our intellectual property rights, where applicable, or a party may use our proprietary information in such a way as to invite litigation that could jeopardize or potentially invalidate our proprietary information or expose us to potential liability;

our partners may not devote sufficient capital or resources towards our products; and

our partners may not comply with applicable government regulatory requirements necessary to successfully market and sell our products.

If any collaborator fails to fulfill its responsibilities in a timely manner, or at all, any research, clinical development, manufacturing or commercialization efforts pursuant to that collaboration could be delayed or terminated, or it may be necessary for us to assume responsibility for expenses or activities that would otherwise have been the responsibility of our collaborator. If we are unable to establish and maintain collaborative relationships on acceptable terms we may have to undertake development and commercialization activities at our own expense.

We may experience difficulties in retaining our existing employees and managing our operations.

We need to retain and maintain our existing managerial, operational, regulatory, developmental, finance and other personnel and resources in order to develop our product candidates and manage our operations. Our current infrastructure may be inadequate to support our strategy and any future workforce reduction, such as the reduction that eliminated approximately 40% of our workforce in May 2022 and subsequent related workforce reductions, may be disruptive to our operations, may negatively affect our productivity, and may constrain our commercialization activities. For example, a further workforce reduction could yield unanticipated consequences, such as attrition beyond planned staff reductions, negatively impacting employee morale and our corporate culture, or increased difficulties in our day-to-day operations, and prevent us from developing our product candidates as rapidly as planned. If we encounter such unanticipated consequences, we may have difficulty retaining and attracting personnel. In addition, the implementation of any additional workforce or expense reduction programs may divert the efforts of our management team and other key employees, which could adversely affect our business. Furthermore, we may not realize, in full or in part, the anticipated benefits, savings and improvements in our cost structure from our cost reduction plan, due to unforeseen difficulties, delays or unexpected costs. If we are unable to realize the expected operational efficiencies and cost savings from the cost reduction plan, our operating results and financial condition would be adversely affected.

If we, or current and potential partners, are unable to compete effectively, our products may not reach their commercial potential.

The U.S. biotechnology and pharmaceutical industries are characterized by intense competition and cost pressure. Our Niyad product candidate, if approved in the U.S., may compete with currently available anticoagulants such as heparin and citrate. The PFS product candidates, if approved in the U.S., may compete with other ready-to-use formulations of ephedrine and phenylephrine. The nafamostat product candidates, if approved in the U.S., may compete with heparin and citrate.

Key competitive factors affecting the commercial success of our approved products are likely to be efficacy, safety profile, reliability, convenience of dosing, price and reimbursement. Many of our competitors and potential competitors have substantially greater financial, technical and human resources than we do and significantly greater experience in the discovery and development of drug candidates, obtaining FDA and other regulatory approval of products, and the commercialization of those products. Accordingly, our competitors may be more successful than we are in obtaining FDA approval for drugs and devices and achieving widespread market acceptance. Our competitors’ drugs, devices or drug delivery systems may be more effective, have fewer adverse effects, be less expensive to develop and manufacture, or be more effectively marketed and sold than any product we may seek to commercialize. This may render our products obsolete or non-competitive. We anticipate that we will face intense and increasing competition as new drugs and devices enter the market, additional technologies become available, and competitors establish collaborative or licensing relationships, which may adversely affect our competitive position. These and other competitive risks may materially adversely affect our ability to attain or sustain profitable operations.

39

Coverage and adequate reimbursement may not be available for our product candidates, if approved, in the United States and in Europe, which could make it difficult for us, or our partners, to sell our products profitably.

Our and our partners’ ability to commercialize our product candidates in the future, if approved, in the United States will depend, in part, on the extent to which coverage and adequate reimbursement will be available from government payer programs at the federal and state levels, authorities, including Medicare and Medicaid, private health insurers, managed care plans and other third-party payers.

No uniform policy requirement for coverage and reimbursement for drug products exists among third-party payers in the United States or Europe. Therefore, coverage and reimbursement can differ significantly from payer to payer. As a result, the coverage determination process is often a time-consuming and costly process that will require us or our partners to provide scientific and clinical support for the use of the approved products to each payer separately, with no assurance that coverage and adequate reimbursement will be applied consistently or obtained in the first instance. For products administered under the supervision of a physician, obtaining coverage and adequate reimbursement may be particularly difficult because of the higher prices often associated with such products. Additionally, separate reimbursement for the product itself or the treatment or procedure in which the product is used may not be available, which may impact utilization. Our or our partners’ inability to promptly obtain and sufficiently maintain coverage and adequate reimbursement rates from third party payers could significantly harm our operating results, our ability to raise capital needed to commercialize our approved drugs and our overall financial condition.

A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payers have attempted to control costs by limiting coverage and the amount of reimbursement for particular medical products. There have been a number of legislative and regulatory proposals to change the healthcare system in the United States and in some foreign jurisdictions that could affect our or our partners’ ability to sell the products profitably. These legislative and/or regulatory changes may negatively impact the reimbursement for our products, following approval. The availability of numerous generic pain medications may also substantially reduce the likelihood of reimbursement for approved products in Europe and elsewhere. The application of user fees to generic drug products may expedite the approval of additional pain medication generic drugs. We would expect that our product candidates will experience pricing pressures in connection with the product sale due to the trend toward managed healthcare, the increasing influence of health maintenance organizations and additional legislative changes. If we or our partners fail to successfully secure and maintain reimbursement coverage for our products or are significantly delayed in doing so, there may be difficulty achieving market acceptance of our products and our business will be harmed.

Furthermore, market acceptance and sales of our products will depend on reimbursement policies and may be affected by future healthcare reform measures. Government authorities and third-party payers, such as private health insurers, hospitals and health maintenance organizations, decide which drugs and devices they will pay for and establish reimbursement levels. We cannot be sure that reimbursement will be available for our product candidates, if approved, in the United States or in Europe. Also, reimbursement amounts may reduce the demand for, or the price of, our products. For example, additional studies in Europe may be needed to ensure premium reimbursement in certain countries. If reimbursement is not available, or is available only to limited levels, we, or our partners, may not be able to successfully commercialize our product candidates, if approved, in the United States or in Europe.

Additionally, the regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs and devices vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a product before it can be marketed. In many countries, the pricing review period begins after marketing or product licensing approval is granted. In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we might obtain marketing approval for a product in a particular country, but then be subject to price regulations that delay commercial launch of the product, possibly for lengthy time periods, and negatively impact the revenues able to be generated from the sale of the product in that country.

40

The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.

If we are found to have improperly promoted off-label uses of our products in the United States, we may become subject to significant liability. Such enforcement has become more common in the industry. The FDA and other regulatory agencies strictly regulate the promotional claims that may be made about prescription drug and device products. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. If the FDA determines that our or our partners’ public disclosures, promotional materials or training constitutes promotion of non-approved or off-label use, it could request modifications to disclosure policies, training or promotional materials or subject us or our partners to regulatory or enforcement actions, including the issuance of an untitled letter, a Warning Letter, injunction, seizure, civil fine or criminal penalties and a requirement for corrective advertising, including Dear Doctor letters. It is also possible that other federal, state or foreign enforcement authorities might take action if they consider our or our partners’ promotional or training materials to constitute promotion of non-approved or off-label use, which could result in significant civil, criminal and/or administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from government-funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, increased losses and diminished profits and the curtailment or restructuring of operations, any of which could adversely affect our or our partners’ ability to operate and, thus, adversely impact our business and our financial results. The FDA or other enforcement authorities could also request that we enter into a consent decree or a corporate integrity agreement or seek a permanent injunction against us under which specified promotional conduct is monitored, changed or curtailed. If we cannot successfully manage the promotion of our product candidates, if approved, in the United States, we could become subject to significant liability, which would materially adversely affect our business and financial condition.

If we or our partners are unable to establish and maintain relationships with group purchasing organizations any future revenues or future profitability could be jeopardized.

Many end-users of pharmaceutical and medical device products have relationships with group purchasing organizations, or GPOs, whereby such GPOs provide such end-users access to a broad range of pharmaceutical and medical device products from multiple suppliers at competitive prices and, in certain cases, exercise considerable influence over the drug and device purchasing decisions of such end-users. Hospitals and other end-users contract with the GPO of their choice for their purchasing needs. We expect to derive revenue from end-user customers that are members of GPOs for our product candidates, if approved. Establishing and maintaining strong relationships with these GPOs will require us to be a reliable supplier, remain price competitive and comply with FDA regulations. The GPOs with whom we have relationships may have relationships with manufacturers that sell competing products, and such GPOs may earn higher margins from these products or combinations of competing products or may prefer products other than ours for other reasons. If we, or our partners, are unable to establish or maintain our GPO relationships, sales of our product candidates, if approved, and related revenues could be negatively impacted.

Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters

 

Existing and future legislation may increase the difficulty and cost for us to commercialize our products and affect the prices we may obtain.

In the United States and some foreign jurisdictions, the legislative landscape continues to evolve, including changes to the regulation of opioid-containing products. There have been a number of legislative and regulatory changes and proposed changes regarding healthcare systems that will restrict or regulate post-approval activities for DSUVIA and DZUVEO and affect our ability to profitably sell any products for which we obtain marketing approval.

In the European Union, or EU, and other European countries the pricing of prescription drugs is subject to government control. The EU also provides options for its member states to restrict the range of medicinal products for which their national health insurance systems provide reimbursement and to control the prices of medicinal products for human use. In addition, the EMA has a “sunset clause” which provides that the marketing authorization of a medicine will cease to be valid if it is not placed on the market within three years of the authorization being granted or if it is removed from the market for three consecutive years; however, the European Commission has extended this date to December 31, 2022 for DZUVEO.

 

In the United States, the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010, or collectively, the Affordable Care Act, was enacted in an effort to, among other things, broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, impose new taxes and fees on the health industry and impose additional health policy reforms. Aspects of the Affordable Care Act that may impact our business include:

extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;

expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;

expansion of eligibility criteria for Medicaid programs, thereby potentially increasing manufacturers’ Medicaid rebate liability;

expansion of healthcare fraud and abuse laws, including the federal False Claims Act and the federal Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance; and

a Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.

 

The Affordable Care Act continues to substantially change health care financing and delivery by both governmental and private insurers, which may increase our regulatory burdens and operating costs.

 

There have been executive, judicial and Congressional challenges to certain aspects of the Affordable Care Act. While Congress has not passed comprehensive repeal legislation, several bills affecting the implementation of certain taxes under the Affordable Care Act have been signed into law. The Tax Cuts and Jobs Act of 2017 includes a provision that repealed, effective January 1, 2019, the tax-based shared responsibility payment imposed by the Affordable Care ActFor example, on certain individuals who fail to maintain qualifying health coverage for all or part of a year that is commonly referred to as the “individual mandate”. On June 17, 2021, the U.S. Supreme Court dismissed a challenge on procedural grounds that argued the Affordable Care Act is unconstitutional in its entirety because the “individual mandate” was repealed by Congress. Thus,In addition, there have been a number of health reform initiatives by the Biden administration that have impacted the Affordable Care Act will remain in effect in its current form. Moreover, prior to the U.S. Supreme Court ruling,. For example, on January 28, 2021,August 16, 2022, President Biden issued an executive order that initiated a special enrollment periodsigned the Inflation Reduction Act of 2022, or the IRA, into law, which among other things, extends enhanced subsidies for purposes of obtainingindividuals purchasing health insurance coverage through thein Affordable Care Act marketplace, which began on February 15, 2021marketplaces through plan year 2025. The IRA also eliminates the “donut hole” under the Medicare Part D program beginning in 2025 by significantly lowering the beneficiary maximum out-of-pocket cost and remained open through August 15, 2021. The executive order instructed certain governmental agencies to review and reconsider their existing policies and rulescreating a new manufacturer discount program. It is possible that limit access to healthcare, including among others, reexamining Medicaid demonstration projects and waiver programs that include work requirements, and policies that create unnecessary barriers to obtaining access tothere will be additional health insurance coverage through Medicaid or the Affordable Care Act.reform measures It is possible that the Affordable Care Act will be subject to judicial or Congressional challenges in the future. It is also unclear how any such challenges and the healthcare reform measures of the Biden administration will impact the Affordable Care Act. We expect that the Affordable Care Act and other healthcare reform measures that may be adopted in the future, could have a material adverse effect on our industry generally and on our ability to successfully commercialize our products. We cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the United States or abroad. If we or our collaborators are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we or our collaborators are not able to maintain regulatory compliance, our products may lose regulatory approval and we may not achieve or sustain profitability, which would adversely affect our business.

 

5041

 

In addition, other legislative changes have been proposed and adopted in the United States since the Affordable Care Act was enacted. Aggregate reductions of Medicare payments to providers of 2% per fiscal year went into effect on April 1, 2013 and due to subsequent legislative amendments to the statute will stay in effect until 2031, with the exception of a temporary suspension from May 1, 2020 through March 31, 2022 due to the COVID-19 pandemic, unless Congressional action is taken. Under current legislation the actual reduction in Medicare payments will vary from 1% in 2022 to up to 4% in the final fiscal year of this sequester. The American Taxpayer Relief Act further reduced Medicare payments to several providers, including hospitals. Additionally, on March 11, 2021, President Biden signed the American Rescue Plan Act of 2021 into law, which eliminates the statutory Medicaid drug rebate cap, currently set at 100% of a drug’s average manufacturer price, for single source and innovator multiple source drugs, beginning January 1, 2024. Congress is also considering additional health reform measures.

Moreover, the Drug Supply Chain Security Act of 2013 imposes additional obligations on manufacturers of pharmaceutical products, among others, related to product tracking and tracing. Among the requirements of this legislation, manufacturers are required to provide certain information regarding the drug product to individuals and entities to which product ownership is transferred, label drug product with a product identifier, and keep certain records regarding the drug product.

 

In the United States, there has been increasing legislative and enforcement interest with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed and enacted federal and state legislation designed to, among other things, bring more transparency to drug pricing and reform government program reimbursement methodologies for drugs. At the federal level, the Trump administration used several means to propose or implement drug pricing reform, including through federal budget proposals, executive orders and policy initiatives. For example, on July 24, 2020 and September 13, 2020, President Trump announced several executive orders related to prescription drug pricing that attempt to implement several of the administration’s proposals. The FDA concurrently released a final rule and guidance in September 2020, implementing a portion of the importation executive order providing pathways for states to build and submit importation plans for drugs from Canada. Further, on November 20, 2020, HHS finalized a regulation removing safe harbor protection for price reductions from pharmaceutical manufacturers to plan sponsors under Part D, either directly or through pharmacy benefit managers, unless the price reduction is required by law. The rule also creates a new safe harbor for price reductions reflected at the point-of-sale, as well as a safe harbor for certain fixed fee arrangements between pharmacy benefit managers and manufacturers. The implementation of the rule has been delayed until January 1, 2027. Further, on November 20, 2020, the Centers for Medicare & Medicaid Services, or CMS, issued an interim final rule implementing President Trump’s Most Favored Nation, or MFN, executive order, which would tie Medicare Part B payments for certain physician-administered drugs to the lowest price paid in other economically advanced countries, effective January 1, 2021. As a result of litigation challenging the MFN model, on December 27, 2021, CMS published a final rule that rescinds the MFN Model interim final rule. In July 2021, the Biden administration released an executive order, “Promoting Competition in the American Economy,” with multiple provisions aimed at prescription drugs. In response to Biden’s executive order, on September 9, 2021, HHS released a Comprehensive Plan for Addressing High Drug Prices that outlines principles for drug pricing reform and sets out a variety of potential legislative policies that Congress could pursue to advance these principles. In addition, the IRA, among other things (i) directs HHS to negotiate the price of certain high-expenditure, single-source drugs and biologics covered under Medicare and (ii) imposes rebates under Medicare Part B and Medicare Part D to penalize price increases that outpace inflation. These provisions will take effect progressively starting in fiscal year 2023, although they may be subject to legal challenges. In addition, the Biden administration released an additional executive order on October 14, 2022, directing HHS to report on how the Center for Medicare and Medicaid Innovation can be further leveraged to test new models for lowering drug costs for Medicare and Medicaid beneficiaries. At the state level, legislatures are increasingly passing legislation and implementing regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, measures designed to encourage importation from other countries and bulk purchasing. Furthermore, even after initial price and reimbursement approvals, reductions in prices and changes in reimbursement levels can be triggered by multiple factors, including reference pricing systems and publication of discounts by third party payers or authorities in other countries. In Europe, prices can be reduced further by parallel distribution and parallel trade (i.e., arbitrage between low-priced and high-priced countries). If any of these events occur, revenue from sales of DZUVEOour products in Europe would be negatively affected. 

 

Legislative and regulatory proposals have been made to expand post-approval requirements and further restrict sales and promotional activities for pharmaceutical products. We are not sure whether additional legislative changes will be enacted, or whether the FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of our products, if any, may be.

 

We expect that additional healthcare reform measures will be adopted within and outside the United States in the future, any of which could negatively impact our business. For instance, it is possible that additional governmental action is taken in response to the COVID-19 pandemic. The continuing efforts of the government, insurance companies, managed care organizations and other payers of healthcare services to contain or reduce costs of healthcare may adversely affect the demand for any drug or device products for which we have obtained or may obtain regulatory approval, our ability to set a price that we believe is fair for our products, our ability to obtain coverage and reimbursement approval for a product, our ability to generate revenues and achieve or maintain profitability, and the level of taxes that we are required to pay.

 

51

Delays in clinical trials are common and have many causes, and any delay could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval and commence product sales.

We have experienced and may in the future experience delays in clinical trials of our product candidates. Our post-approval clinical trials for DSUVIA, or any future FDA-required clinical trials for our product candidates, could be delayed for a variety of reasons, including:

inability to raise funding necessary to initiate or continue a trial;

inability to pay significant FDA filing fees;

delays in obtaining regulatory approval to commence a trial;

delays in reaching agreement with the FDA on final trial design;

imposition of a clinical hold by the FDA, Institutional Review Board, or IRB, or other regulatory authorities;

delays in reaching agreement on acceptable terms with prospective contract research organizations, or CROs, and clinical trial sites;

delays in obtaining required IRB approval at each site;

delays in recruiting suitable patients to participate in a trial;

delays in the testing, validation, manufacture and delivery of the tablets and device components of DSUVIA;

delays in having patients complete participation in a trial or return for post-treatment follow-up;

clinical sites dropping out of a trial to the detriment of enrollment or being delayed in entering data to allow for clinical trial database closure;

time required to add new clinical sites; or

delays by our contract manufacturers to produce and deliver sufficient supply of clinical trial materials.

If any future FDA-required clinical trials are delayed for any reason, our development costs may increase, our approval process for our product candidates could be delayed, our ability to commercialize and commence sales of our product candidates could be materially harmed, and our ability to maintain FDA approval of DSUVIA could be jeopardized, which could have a material adverse effect on our business.

DSUVIA may cause adverse effects or have other properties that could limit market acceptance.

In our Phase 2 DSUVIA placebo-controlled bunionectomy study (SAP202), two patients in the DSUVIA 30 mcg group (5%) discontinued treatment due to an AE, one unrelated to study drug and the other probably related to study drug. There were no SAEs deemed related to study drug. In our Phase 3 placebo-controlled abdominal surgery study (SAP301), one DSUVIA-treated patient (1%) dropped out of the trial prematurely due to an AE (4% in placebo group). There were two SAEs determined to be related to study drug in the placebo-treated group and no related SAEs in the DSUVIA group. In our Phase 3 open-label, single-arm emergency room study (SAP302), no DSUVIA-treated patients dropped out of the trial prematurely due to an AE. One patient had an SAE – angina pectoris – possibly related to study drug. In our post-operative study in patients aged 40 years or older (SAP303), 3% of DSUVIA-treated patients dropped out of the trial prematurely due to an AE. There were no SAEs deemed related to study drug.

If DSUVIA causes serious or unexpected side effects, a number of potentially significant negative consequences could result, including:

regulatory authorities may withdraw their approval of the product or impose restrictions on its distribution in the form of a modified REMS program;

regulatory authorities may require the addition of labeling statements, such as warnings or contraindications;

we may be required to change the way the product is administered or conduct additional clinical trials;

we could be sued and held liable for harm caused to patients; or

our reputation may suffer.

Any of these events could prevent us from achieving or maintaining market acceptance of DSUVIA and could substantially increase the costs of commercializing our products.

52

The process for obtaining approval of an NDA is time consuming, subject to unanticipated delays and costs, and requires the commitment of substantial resources.

If the FDA determines that any of the clinical work submitted, including the clinical trials, Human Factors studies and bench testing submitted for a product candidate in support of an NDA were not conducted in full compliance with the applicable protocols for these trials, studies and testing as well as with applicable regulations and standards, or if the FDA does not agree with our interpretation of the results of such trials, studies and testing, the FDA may reject the data and results. The FDA may audit some or all of our clinical trial sites to determine the integrity of our clinical data. The FDA may audit some or all of our Human Factors study sites to determine the integrity of our data and may audit the data and results of bench testing. Any rejection of any of our data would negatively impact our ability to obtain marketing authorization for our product candidates and would have a material adverse effect on our business and financial condition. In addition, an NDA may not be approved, or approval may be delayed, as a result of changes in FDA policies for drug approval during the review period. For example, although many products have been approved by the FDA in recent years under Section 505(b)(2) of the FDCA, objections have been raised to the FDA’s interpretation of Section 505(b)(2). If challenges to the FDA’s interpretation of Section 505(b) (2) are successful, the FDA may be required to change its interpretation, which could delay or prevent the approval of such an NDA. Any significant delay in the acceptance, review or approval of an NDA that we have submitted would have a material adverse effect on our business and financial condition and would require us to obtain significant additional funding.

Although we have obtained regulatory approval for DSUVIA, and even if we obtain regulatory approval for our product candidates in the United States, we and our collaborators face extensive regulatory requirements, and our products may face future development and regulatory difficulties.

Although we have obtained regulatory approval for DSUVIA, and even if we obtain regulatory approval for our product candidates in the United States, the FDA may impose significant restrictions on the indicated uses or marketing of our products or impose ongoing requirements for potentially costly post-approval trials or post-market surveillance. For example, DSUVIA is subject to a deferred post-marketing requirement for study in the pediatric population ages 6-17 years. A final protocol for this trial was submitted to the FDA in August 2020, in conjunction with a previously FDA approved request to defer initiation of pediatric studies until additional post-market safety data is obtained in adult patients using DSUVIA. Additionally, the labeling approved for DSUVIA includes restrictions on use due to the opioid nature of sufentanil.

DSUVIA in the United States is also subject to ongoing FDA requirements governing the labeling, packaging, storage, distribution, safety surveillance, advertising, promotion, record-keeping and reporting of safety and other post-market information. The holder of an approved NDA is obligated to monitor and report AEs and any failure of a product to meet the specifications in the NDA. The holder of an approved NDA must also submit new or supplemental applications and obtain FDA approval for certain changes to the approved product, product labeling or manufacturing process.

Advertising and promotional materials must comply with FDA rules and are subject to FDA review, in addition to compliance with other potentially applicable federal and state laws. Failure to comply with these regulations can result in the receipt of Warning Letters and further liability if off-label promotion is involved. For example, on February 11, 2021, we received a Warning Letter from the Office of Prescription Drug Promotion, or OPDP, of the FDA relating to a banner advertisement we submitted to the OPDP on December 6, 2019, and a tabletop display we submitted on February 28, 2020, and resubmitted to the OPDP at its request on September 23, 2020.  Although we believe we have updated all promotional materials currently in use by our commercial team to address the FDA's concerns and we received a close-out Letter to the Warning Letter in March 2022, we cannot give any assurances that we will not receive additional FDA Warning Letters in the future. If approved, our product candidates will be subject to these same requirements.

We must also register and obtain various state prescription drug distribution licenses and controlled substance permits, and any delay or failure to obtain or maintain these licenses or permits may limit our market and materially impact our business. In certain states we cannot apply for a license until a drug is approved by the FDA. The state licensing process may take several months which would delay commercialization in those states. In addition, manufacturers of drug products and their facilities are subject to payment of user fees and continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMPs and adherence to commitments made in the NDA. If we, or a regulatory agency, discover previously unknown problems with a product, such as AEs of unanticipated severity or frequency, or problems with the facilities where the product is manufactured, a regulatory agency may impose restrictions relative to that product or the manufacturing facilities, including requiring recall or withdrawal of the product from the market or suspension of manufacturing.

If we fail to comply with applicable regulatory requirements following approval of our products, a regulatory agency may:

issue a Warning Letter asserting that we are in violation of the law;

seek an injunction or impose civil or criminal penalties or monetary fines;

suspend or withdraw regulatory approval;

suspend any ongoing clinical trials;

refuse to approve a pending NDA or supplements to an NDA submitted by us;

seize product; or

53

refuse to allow us to enter into supply contracts, including government contracts.

Any government investigation of alleged violations of law could require us to expend significant time and resources in response and could generate negative publicity. The occurrence of any event or penalty described above may inhibit our ability to commercialize DSUVIA, or, if approved, our product candidates, and generate revenues.

Except for DZUVEO, which is approved in Europe, we may never obtain additional regulatory approvals for our products and product candidates outside of the United States, which would limit our ability to realize their full market potential.

In order to market any products outside of the United States, we or our commercial partners, must establish and comply with numerous and varying regulatory requirements of other countries regarding safety and efficacy. In June 2018, we announced that the EC had granted marketing approval of DZUVEO for the treatment of patients with moderate-to-severe acute pain in medically monitored settings. In July 2021, we entered into the DZUVEO Agreement with Aguettant.

Part of the foreign regulatory approval process includes compliance inspections of manufacturing facilities to ensure adherence to applicable regulations and guidelines. The foreign regulatory agency may delay, limit or deny marketing approval as a result of such inspections. We, our contract manufacturers, and their vendors, are all subject to preapproval and post-approval inspections at any time. The results of these inspections could impact our ability to obtain regulatory approval of DSUVIA/DZUVEO or our product candidates in countries outside of the United States and Europe, or our ability to launch and successfully commercialize these products, once approved. In addition, results of EMA inspections could impact our ability to maintain EC approval of DZUVEO and Aguettant’s ability to expand and sustain commercial sales of DZUVEO in Europe.

Outside of Europe, clinical trials conducted in one country may not be accepted by regulatory authorities in other countries, and regulatory approval in one country does not mean that regulatory approval will be obtained in any other country. Approval processes vary among countries and can involve additional product testing and validation and additional administrative review periods. Seeking foreign regulatory approval could result in difficulties and costs for us and require additional non-clinical trials or clinical trials, which could be costly and time consuming. Regulatory requirements can vary widely from country-to-country and could delay or prevent the introduction of our products in those countries. Our current clinical trial data may not be sufficient to support marketing approval or premium reimbursement in all territories. For example, we anticipate we may need comparator studies for DZUVEO in Europe to ensure premium reimbursement in certain countries. While we have obtained approval of DZUVEO in Europe, we will be substantially dependent on Aguettant to comply with regulatory requirements. If we, or our commercial partners, fail to comply with regulatory requirements in international markets or to obtain and maintain required approvals, or if regulatory approvals in international markets are delayed, our target market will be reduced and our ability to realize the full market potential of our products will be harmed.

DSUVIA requires a REMS program.

DSUVIA was approved in the United States with a REMS program. The DSUVIA REMS program includes restrictions on product distribution and use only in certified medically supervised settings. Before DSUVIA is distributed, an authorized representative from each medically supervised setting must sign an attestation that they have the ability to manage acute opioid overdose and will train all relevant staff on administration of DSUVIA, including the importance of only dispensing the product in a medically supervised setting. Therefore, REMS-certification is a key gating item to generating product revenues for DSUVIA. In addition, the REMS program for DSUVIA may significantly increase our costs to commercialize this product.

Risks Related to Our Financial Condition and Need for Additional Capital

 

We have incurred significant losses since our inception and anticipate that we will continue to incur losses in the future.

 

We have incurred significant net losses since our inception in July 2005, and as of SeptemberJune 30, 2022,2023, we had an accumulated deficit of $418.3$438.4 million. In addition, we have generated negative cash flows from operations and we expect to incur significant losses in 2023 and may incur significant losses and negative cash flows from operations in the future. These conditions raise substantial doubt about our ability to continue as a going concern.

 

We have devoted most of our financial resources to research and development, including our non-clinical development activities and clinical trials. To date, we have financed our operations primarily through the issuance of equity securities, borrowings, payments from Grünenthal, the monetization of certain future royalties and commercial sales milestones from the European sales of Zalviso by Grünenthal, funding from the Department of Defense, or DoD, and more recently with revenues from sales of DSUVIA, sinceand payments under the commercial launch in the first quarter of 2019 and the upfront payment under theAmended DZUVEO Agreement with Aguettant. The size of our future net losses will depend, in part, on the rate of future expenditures and our ability to generate revenues. We expect to continue to incur substantial expenses as we support commercialization activities for DSUVIA, manufacturing and supply activities for DZUVEO, and research and development activities for our product candidates. If DSUVIA is not successfully commercialized in the U.S., if our product candidates are not successfully developed or commercialized in the U.S., or if revenues are insufficient following marketing approval, we will not achieve profitability and our business may fail. Our success is also dependent on current and future collaborations to market our products outside of the United States, which may not materialize or prove to be successful.

 

5442

 

We require additional capital and may be unable to raise such capital, which would force us to delay, reduce or eliminate our commercialization efforts and product development programs and could cause us to be unable to continue to operate as a going concern and cease operations.

 

Launch of a commercial pharmaceutical product and pharmaceutical development activities can be time consuming and costly. We expect to incur significant expenditures in connection with supporting our ongoing commercialization activities for DSUVIA, manufacturing and supply activities for DZUVEO, and research and development activities for our product candidates.

 

Clinical trials, regulatory reviews, and the launch of a commercial product are expensive activities. In addition, commercialization costs for DSUVIA and our product candidates, if approved, in the United States may be significantly higher than estimated as a result of technical difficulties or otherwise. Revenues may be lower than expected and costs to produce such revenues may exceed those revenues. We will need to seek additional capital to continue operations. Such capital demands could be substantial. In the future, we may seek to sellraise such additional capital through public or private equity securities,offerings, including under the Controlled Equity OfferingSMSales Agreement, or the ATM Agreement, with Cantor Fitzgerald & Co., or Cantor, as agent, and debt securities, monetizea new debt facility, monetizing or securitizesecuritizing certain assets, refinance our loan agreement, enterentering into product development, license or distribution agreements with third parties, or divest DSUVIA in the United States, DZUVEO in Europe, ordivesting any of our product candidates. Such arrangements may not be available on favorable terms, if at all.

 

If we are unsuccessful in efforts to raise additional capital, based on our current levels of operating expenses, our current capital is not expected to be sufficient to fund our operations for the next twelve months. These conditions raise substantial doubt about our ability to continue as a going concern.

 

The unaudited condensed consolidated financial statements for the three and nine monthsquarterly period ended SeptemberJune 30, 20222023 were prepared on the basis of a going concern, which contemplates that we will be able to realize our assets and discharge liabilities in the normal course of business. TheThese financial statements do not include any adjustments that might be necessary if we are unable to continue as a going concern.

 

Future events and circumstances, including those beyond our control, may cause us to consume capital more rapidly than we currently anticipate. Furthermore, any product development, licensing, distribution or sale agreements that we enter into may require us to relinquish valuable rights. We may not be able to obtain sufficient additional funding or enter into a strategic transaction in a timely manner. If adequate funds are not available, we would be required to reduce our workforce, reduce the scope of, or cease, the development and subsequent potential commercial launch of DSUVIA, or the development of our product candidates in advance of the date on which we exhaust our cash resources to ensure that we have sufficient capital to meet our obligations and continue on a path designed to preserve stockholder value.

 

Securing additional financing may divert our management from our day-to-day activities, which may adversely affect our ability to commercialize DSUVIA or develop our product candidates. In addition, we cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at all. If we are unable to raise additional capital when required or on acceptable terms, we may be required to:

 

 

further scale back or discontinue the commercialization of DSUVIA, or the development of our product candidates;

 

seek corporate partners for DSUVIA, or DZUVEO, or our product candidates on terms that might be less favorable than might otherwise be available; or

 

relinquish, or license on unfavorable terms, our rights to technologies, products or product candidates that we otherwise would seek to develop or commercialize ourselves.

 

During the past several years, domestic and international financial markets have experienced, and they may continue to experience, extreme disruption from time to time, including, among other things, high volatility, significant declines in stock prices and severely diminished liquidity and credit availability for both borrowers and investors. Such adverse capital and credit market conditions could make it more difficult to obtain additional capital on favorable terms, or at all, which could have a material adverse effect on our business and growth prospects. For example, our ability to raise additional capital may be adversely impacted by deteriorating global economic conditions and the disruptions to and volatility in the credit and financial markets in the U.S. and worldwide resulting from the evolving effects of the COVID-19 pandemic and the ongoing military conflict between RussianRussia and Ukraine and related sanctions imposed against Russia.

43

 

To fund our operations and capital requirements, we may sell additional equity securities, which may result in dilution to our stockholders, or debt securities, or enter into a new debt facility which may impose restrictions on our business.

 

We expect that significant additional capital will be needed in the future to continue our planned operations and capital requirements. In the long-term, our existing capital resources will not be sufficient to fund our operations until such time as we may be able to generate sufficient revenues to sustain our operations. In order to raise additional funds to support our operations, we may sell additional equity securities, including under the ATM Agreement with Cantor. We may sell common stock, convertible securities, or other equity securities in one or more transactions at prices and in a manner we determine from time to time. Selling additional equity securities may result in dilution to our existing stockholders and new investors may be materially diluted by subsequent sales. Incurring additional indebtedness, including through the sale of debt securities or entering into a new debt facility, would result in increased fixed payment obligations and could also result in additional restrictive covenants, such as limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions, such as minimum cash balances, that could adversely impact our ability to conduct our business. Sales of equity or debt securities may also provide new investors with rights superior to our existing stockholders. If we are unable to expand our operations or otherwise capitalize on our business opportunities, our business, financial condition and results of operations could be materially adversely affected, and we may not be able to meet our debt service obligations.

 

55

We have not yet generated significant product revenue and may never be profitable.

 

Our ability to generate revenue from commercial sales and/or royalties and achieve profitability depends on our ability, alone and with collaborators, to successfully complete the development of, obtain the necessary regulatory approvals for, and commercialize our products. Although we received FDA approval of DSUVIA and began the commercial launch of DSUVIA in the United States, we may never generate enough revenues from sales of DSUVIA, or our product candidates, if approved, in the United States to become profitable. Although the EC granted marketing approval of DZUVEO in June 2018, we only recently entered into the DZUVEO Agreement with Aguettant to commercialize DZUVEO in Europe and thereThere can be no assurance that AguettantAlora pursuant to the DSUVIA Agreement will successfully commercialize DZUVEO.DSUVIA. Although we had a collaboration agreement with Grünenthal for commercialization of Zalviso in Europe and Australia, Grünenthal was unable to achieve a level of commercial sales of Zalviso to trigger sales milestone payments that would have been payable to us. The Grünenthal Agreements have been terminated and Grünenthal’s rights to market and sell Zalviso reverted back to us on May 12, 2021. The European Marketing Authorization for Zalviso was withdrawn in July 2022.

 

We do not anticipate generating significant near-term revenues fromunder the DSUVIA Agreement or from our product candidates, if approved, in the United States. Our ability to generate future revenues from product sales depends heavily on ourthe success in:

 

 

maintaining regulatory approval for DSUVIA and obtaining and maintaining regulatory approval for our product candidates in the United States; and

 

launching and commercializing DSUVIA and our product candidates, if approved, in the United States by building, internally or through collaborations, an institutionally focused sales force, and launching and commercializing DZUVEO internationally through collaborations, which may require additional funding.

 

Because of the numerous risks and uncertainties associated with launching a commercial pharmaceutical product, pharmaceutical product development and the regulatory environment, we are unable to predict the timing or amount of increased expenses, or when, or if, we will be able to achieve or maintain profitability. Our expenses could increase beyond expectations if we are delayed in receiving regulatory approval for our product candidates in the United States, or if we are required by the FDA to complete activities in addition to those we currently anticipate or have already completed.

 

We anticipate continuing to incur significant costs associated with commercializing DSUVIA in the United States. Even if we are able to generate revenues fromunder the sale of DSUVIA Agreement or from our product candidates, if approved, in the United States, we may not become profitable and may need to obtain additional funding to continue operations.

 

Future sales of DSUVIA to the DoD are not predictable, may occur on an irregular basis and may not meet our expectations due to various U.S. government-related factors that are beyond our control and into which we have little to no visibility, including the timing and extent of future U.S. military deployments. If DoD spending on DSUVIA does not meet our expectations, it could adversely affect our expected results of operations, financial condition and liquidity.

 

In April 2020, DSUVIA achieved Milestone C approval by the DoD, a decision that clears the path for the DoD to begin placing orders for DSUVIA to fulfill its updating requirements for all Army Sets, Kits, and Outfits, or SKOs, for deployed/deploying troops. Completion of this SKO fulfillment process is dependent on the Army’s completion of their product information package including instructions on fulfillment and training which remains in process. In September 2020, we announced that DSUVIA was added to the DoD Joint Deployment Formulary, a core list of pharmaceutical products that are designated for deploying military units across all service branches. Under the DSUVIA Agreement, Alora will be responsible for commercializing DSUVIA except that we will retain the responsibility for driving the demand within the DoD, and we will receive quarterly payments in an amount equal to 75% of net Product sales to the DoD. Refer to Note 3, “Discontinued Operations” to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information. Future sales of DSUVIA by Alora to the DoD are not predictable, may occur on an irregular basis, and may not meet our expectations due to various U.S. government-related factors that are beyond our control and into which we have little to no visibility, including the timing and extent of future U.S. military deployments. Even if we doAlora does generate revenue from such sales and we receive payments, we may never generate revenue that is significant or predictable, which could impair our value and our ability to raise capital, expand our business or continue our operations. The placement of new orders by the DoD is, among other things, contingent upon overall U.S. government policies, budget and appropriation decisions and processes which are driven by numerous factors, including geo-political events, deployment of military units, macroeconomic conditions, and the ability of the U.S. government to enact relevant legislation, such as appropriations bills and accords on the debt ceiling. Our expectations about theThe timing and size of initial stocking orders for the SKOs and other orders by the DoD are based on our understanding of troop deployment schedules. If DoD spending on DSUVIA does not meet our expectations, it could have a material adverse effect on our expected results of operations, financial condition and liquidity.

 

5644

 

We will be substantially dependent on Aguettant to successfully commercialize DZUVEO in Europe.

In June 2018, the EC granted marketing approval for DZUVEO and in July 2021 we entered into the DZUVEO Agreement with Aguettant to commercialize DZUVEO in Europe. Aguettant has recently begun the launch of DZUVEO in Europe. We will be substantially dependent on Aguettant to successfully commercialize DZUVEO in Europe. Any failures in the commercialization of DZUVEO in Europe could have a significant adverse impact on our revenues and operating results.

The DZUVEO Agreement requires us to support the manufacturing and supply of DZUVEO for Aguettant. In addition, we anticipate we may need comparator studies in Europe to ensure premium reimbursement in certain countries. Our inability to profitably manufacture and supply DZUVEO to Aguettant, or to successfully complete these additional comparator studies and obtain premium reimbursement in certain countries, may prevent, limit or delay commercialization and any associated future revenues from DZUVEO in Europe.

We have limited experience commercializing DSUVIA, which may make it difficult to predict our future performance or evaluate our business and prospects.

Since inception, our operations have been primarily focused on developing our technology and undertaking pharmaceutical development and clinical trials for DSUVIA and Zalviso, understanding the market potential for DSUVIA and Zalviso, and preparing for the commercialization of DSUVIA in the United States. We launched commercialization efforts for DSUVIA in February 2019. As a result of our limited commercialization experience, any predictions that are made about our future performance, or viability, or evaluation of our business and prospects, may not be accurate.

The terms of our loan agreement with Oxford may restrict our current and future operations, particularly our ability to respond to changes in business or to take certain actions, including to pay dividends to our stockholders.

On May 30, 2019, we entered into the Loan Agreement with Oxford Finance LLC, or Oxford, a Delaware limited liability company, as the Lender. The Loan Agreement contains, and any future indebtedness we incur will likely contain, a number of restrictive covenants that impose operating restrictions, including restrictions on our ability to engage in acts that may be in our best long-term interests. The Loan Agreement includes covenants that, among other things, restrict our ability to (i) declare dividends or redeem or repurchase equity interests; (ii) incur additional liens; (iii) make loans and investments; (iv) incur additional indebtedness; (v) engage in mergers, acquisitions, and asset sales; (vi) transact with affiliates; (vii) undergo a change in control; (viii) add or change business locations; and (ix) engage in businesses that are not related to our existing business. The Loan Agreement also requires that we at all times maintain unrestricted cash of not less than $5.0 million.

A breach of any of these covenants could result in an event of default under the Loan Agreement. Upon the occurrence of such an event of default, a default interest rate of an additional 5% may be applied to the outstanding loan balances and all outstanding obligations under the Loan Agreement can be declared to be immediately due and payable If our indebtedness is accelerated, we cannot assure you that we will have sufficient assets to repay the indebtedness. The restrictions and covenants in the Loan Agreement and any future financing agreements may adversely affect our ability to finance future operations or capital needs or to engage in other business activities.

We might be unable to service our existing debt due to a lack of cash flow and might be subject to default.

As of September 30, 2022, we had approximately $7.4 million of outstanding debt under the Loan Agreement. The Loan Agreement has a scheduled maturity date of June 1, 2023 and is secured by a first priority security interest in substantially all of our assets, with the exception of our intellectual property and those assets sold under the Royalty Monetization, where the security interest is limited to proceeds of intellectual property if it is licensed or sold.

If we do not make the required payments when due, either at maturity, or at applicable installment payment dates, or if we breach the agreement or become insolvent, the Lender could elect to declare all amounts outstanding, together with accrued and unpaid interest, and other payments, to be immediately due and payable. Additional capital may not be available on terms acceptable to us, or at all. Even if we were able to repay the full amount in cash, any such repayment could leave us with little or no working capital for our business. If we are unable to repay those amounts, the Lender will have a first claim on our assets pledged under the Loan Agreement. If the lender should attempt to foreclose on the collateral, it is unlikely that there would be any assets remaining after repayment in full of such secured indebtedness. Any default under the Loan Agreement and resulting foreclosure would have a material adverse effect on our financial condition and our ability to continue our operations.

57

Risks Related to Our Reliance on Third Parties

 

We will rely on third party manufacturers to produce commercial supplies of DSUVIA in the United States, and DZUVEO for Aguettant in Europe, and will rely on Aguettant to produce commercialclinical supplies of our PFS product candidates, if approved, in the United States.candidates. The failure of third-party manufacturers to provide us with adequate commercial and clinical supplies could result in a material adverse effect on our business.

 

ThirdWe currently use third party manufacturers produce commercial and clinical supplies of our products and product candidates. Reliance on third party manufacturers entails many risks including:

 

 

the inability to meet our product specifications and quality requirements consistently;

 

the inability to procure raw materials in a timely fashion due to ongoing challenges in the global supply chain;

 

a delay or inability to procure or expand sufficient manufacturing capacity;

 

manufacturing and product quality issues related to scale-up of manufacturing;

 

costs and validation of new equipment and facilities required for scale-up;

 

a failure to maintain in good order our production and manufacturing equipment for our products;

 

a failure to comply with cGMP and similar foreign standards;

 

the inability to negotiate manufacturing or supply agreements with third parties under commercially reasonable terms;

 

termination or nonrenewal of manufacturing or supply agreements with third parties in a manner or at a time that is costly or damaging to us;

 

the reliance on a limited number of sources, and in some cases, single sources for product components, such that if we are unable to secure a sufficient supply of these product components, we will be unable to manufacture and sell our products in a timely fashion, in sufficient quantities or under acceptable terms;

 

the lack of qualified backup suppliers for those components that are currently purchased from a sole or single source supplier;

 

operations of our third-party manufacturers or suppliers could be disrupted by conditions unrelated to our business or operations, including the bankruptcy of the manufacturer or supplier, or government orders related to the COVID-19 pandemic;

 

carrier disruptions or increased costs that are beyond our control; and

 

the failure to deliver our products under specified storage conditions and in a timely manner.

 

Any of these events could lead to stock outs, inability to successfully commercialize our products, clinical trial delays, or failure to obtain regulatory approval. Some of these events could be the basis for FDA action, including injunction, recall, seizure, or total or partial suspension of production.

In addition, the DZUVEO Agreement requires us to manufacture and supply DZUVEO to Aguettant. If we are unable to establish a reliable commercial supply of DZUVEO for Aguettant, we may be unable to satisfy our obligations under the DZUVEO Agreement in a timely manner or at all, and we may, as a result, be in breach of then DZUVEO Agreement. If any such breach, or other breach, were to be material and remain uncured, it could result in termination of the DZUVEO Agreement. If any of these events were to occur, our business would be materially adversely affected.

 

We rely on limited sources of supply for the active pharmaceutical ingredient, or API, of DSUVIAour nafamostat-based product candidates and any disruption in the chain of supply may cause a delay in supplying DSUVIA.developing our product candidates.

 

Currently we onlyWe currently have one supplier qualified as a vendorsingle source of supply of API for the manufacture of DSUVIA, known as DZUVEO in Europe, with the FDA and EMA, respectively.our nafamostat-based product candidates. If supply from the approvedthat vendor is interrupted or discontinued, there could be a significant disruption in commercial supply. Any alternate vendor would need to be qualified through an NDA supplement and/or an MAA variation which could result in delays. The FDA or other regulatory agencies outside of the United States may also require additional trials if a new sufentanil supplier is relied uponimpact on our development activities for commercial production.

Manufacture of sufentanil sublingual tablets requires specialized equipment and expertise.

Ethanol, which is used in the manufacturing process for our sufentanil sublingual tablets, is flammable, and sufentanil is a highly potent, Schedule II controlled substance. These factors necessitate the use of specialized equipment and facilities for manufacture of sufentanil sublingual tablets. There are a limited number of facilities that can accommodate our manufacturing process and we or our partners need to use dedicated equipment throughout development and commercial manufacturing to avoid the possibility of cross-contamination. If our or our partners’ equipment breaks down or needs to be repaired or replaced, it may cause significant disruption in clinical or commercial supply, which could result in delay in the process of obtaining approval for or sale of our products. Furthermore, we are using one manufacturer to produce our sufentanil sublingual tablets. Any problems with our or our partners’ facilities or equipment may impair our ability to successfully commercialize DSUVIA and increase our cost.those product candidates.

 

5845

 

Manufacturing issues may arise that could delay or increase costs related to commercialization, product development and regulatory approval.

 

We have relied, and will continue to rely, on contract manufacturers, component fabricators and third-party service providers to produce the necessary DSUVIA/DZUVEO single-dose applicator, or SDA,Niyad product for theclinical and non-clinical development and eventually for commercial marketplace.sales. We currently outsource manufacturing and packaging of DSUVIA/DZUVEONiyad to third parties and intend to continue to do so. Some of theseThese component purchases were made and will continue to be made utilizing short-term purchase agreements and we may not be able to enter into long-term agreements for commercial supply of DSUVIA/DZUVEO components with these third-party manufacturers or may be unable to do so on acceptable terms. In addition, we have encountered and may continue to encounter production issues with our current or future contract manufacturers and other third partythird-party service providers, including the reliability of the production equipment, quality of the components produced, their inability to meet demand or other unanticipated delays including scale-up and automating processes, which could adversely impact our ability to supply our customers with DSUVIA, in the U.S. and DZUVEO in Europe, and any other foreign territories.delays.

 

As we scale up manufacturing of DSUVIA/DZUVEO,Niyad in the future to support commercial demand, and conduct required production and stability testing, these processes may require refinement or resolution. For example, as we scale up, we may identify significant issues which could result in failure to maintain regulatory approval of DSUVIA/DZUVEO,Niyad, increased scrutiny by regulatory agencies, delays in clinical development and regulatory approval, of our product candidates, increases in our operating expenses, or failure to obtain approval for our product candidates in the United States.

 

We have built out a suite within our CMO’s production facility in Cincinnati, Ohio that serves as a manufacturing facility for clinical and commercial supplies of sufentanil sublingual tablets. Late-stage development and manufacture of registration stability lots, which were utilized in clinical trials, were manufactured at this location. While we produced a number of commercial lots to support Grünenthal’s launch in Europe, our experience is limited, which impacted our ability to deliver commercial supplies to Grünenthal on a timely basis, and may in the future impact our ability to deliver commercial supplies of DZUVEO to Aguettant on a timely basis.

On August 22, 2017, we entered into an amendment to our January 2013 agreement with a CMO to manufacture, supply, and provide certain validation and stability services with respect to DSUVIA for sales in the United States, and potential sales in Canada and Mexico, and other countries. There is no guarantee that our CMO’s services will be satisfactory or that they will continue to meet the strict regulatory guidelines of the FDA or other foreign regulatory agencies. If our CMO cannot provide us with an adequate supply of sufentanil sublingual tablets, we may be required to pursue alternative sources of manufacturing capacity. Switching or adding commercial manufacturing capability can involve substantial cost and require extensive management time and focus, as well as additional regulatory filings which may result in significant delays. In addition, there is a natural transition period when a new manufacturing facility commences work. As a result, delays may occur, which can materially impact our ability to meet our desired commercial timelines, thereby increasing our costs and reducing our ability to generate revenue.

The facilities of any of our future manufacturers of sufentanil-containing sublingual tabletsNiyad must be approved by the FDA or the relevant foreign regulatory agency, such as the EMA, before commercial distribution from such manufacturers occurs. We do not fully control the manufacturing process of sufentanil sublingual tablets and are completely dependent on these third-party manufacturing partners for compliance with the FDA or other foreign regulatory agency’s requirements for manufacture. In addition, although our third-party manufacturers are well-established commercial manufacturers, we are dependent on their continued adherence to cGMP manufacturing and acceptable changes to their process.processes. If our manufacturers do not meet the FDA or other foreign regulatory agency’s strict regulatory requirements, they will not be able to secure FDA or other foreign regulatory agency approval for their manufacturing facilities. Although European inspectors have approved our tablet manufacturing site, our third-party manufacturing partner is responsible for maintaining compliance with the relevant foreign regulatory agency’s requirements. If the FDA or the relevant foreign regulatory agency does not approve these facilities for the commercial manufacture of sufentanil sublingual tablets,Niyad, we will need to find alternative suppliers, which would result in significant delays in obtaining foreign regulatory agency approval of DSUVIA/DZUVEO outside Europe.approval. These challenges may have a material adverse impact on our business, results of operations, financial condition and prospects.

 

We may not be able to establish additional sources of supply for sufentanil-containing sublingual tablets or device manufacture.Niyad. Such suppliers are subject to FDA and other foreign regulatory agency’s regulations requiring that materials be produced under cGMPs or Quality System Regulations, or QSR, or in ISO 13485 accredited facilities, and subject to ongoing inspections by regulatory agencies.QSR. Failure by any of our suppliers to comply with applicable regulations may result in delays and interruptions to our product supply while we seek to secure another supplier that meets all regulatory requirements.

For DSUVIA, we currently package the finished goods under a manual process and would package DZUVEO in the same manner. The capacity and cost to package the goods under this manual process are not optimal to support successful future sales of DSUVIA and DZUVEO. We have purchased and installed an automated filling and packaging line to support increased capacity packaging for DSUVIA and DZUVEO. We have experienced delays to final implementation of our automated linedelays. In addition, due to the impact of COVID-19, in addition to testing requirements of our vendor. While we have now completed the acquisition and installation of this line; there can be no assurance that we will be able to successfully complete the qualification and validation of this line and obtain the necessary regulatory approvals to manufacture commercial product on this line. Due to the recent strains on the global supply chain, the lead timetimes for many components used in our production are getting longer and may impact our ability to manufacture our products in a timely manner.

59

 

We rely on third parties to conduct, supervise and monitor our clinical trials, and if those third parties perform in an unsatisfactory manner, it may harm our business.

 

We utilized contract research organizations, or CROs, for the conduct of the Phase 2 and 3 clinical trials of DSUVIA, as well as our Phase 3 clinical program for Zalviso. We will also utilize CROs for development of our product candidates. We will continue to rely on such CROs, as well as clinical trial sites, to ensure the proper and timely conduct of our clinical trials and document preparation. While we have agreements or will enter into such agreements governing their activities, we have limited influence over their actual performance. We have relied and plan to continue to rely upon CROs to monitor and manage data for our post-approval clinical programs for DSUVIA and any FDA-required clinical programs for our product candidates, as well as the execution of nonclinical and clinical trials. We control only certain aspects of our CROs’ activities. Nevertheless, we are responsible for ensuring that each of our trials is conducted in accordance with the applicable protocol, legal, regulatory and scientific standards and our reliance on the CROs does not relieve us of our regulatory responsibilities.

 

We, and our CROs, are required to comply with the FDA’s current good clinical practices, or cGCPs, which are regulations and guidelines enforced by the FDA for all product candidates in clinical development. The FDA enforces these cGCPs through periodic inspections of trial sponsors, principal investigators and clinical trial sites. If we or our CROs fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA may require us to perform additional clinical trials before approving our marketing applications. Upon inspection, the FDA may determine that our clinical trials do not comply with cGCPs. Accordingly, if our CROs or clinical trial sites fail to comply with these regulations, we may be required to repeat clinical trials, which would delay the regulatory process.

 

Our CROs are not our employees, and we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and nonclinical programs. These CROs may also have relationships with other commercial entities, including our competitors, for whom they may also be conducting clinical trials, or other drug development activities which could harm our competitive position. We face the risk of potential unauthorized disclosure or misappropriation of our intellectual property by CROs, which may allow our potential competitors to access our proprietary technology. If our CROs do not successfully carry out their contractual duties or obligations, fail to meet expected deadlines, or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols or regulatory requirements, or for any other reasons, our clinical trials may be extended, delayed or terminated, and we may not be able to obtain regulatory approval for, or successfully commercialize our product candidates. As a result, our financial results and the commercial prospects for our product candidates, if approved, would be harmed, our costs could increase, and our ability to generate revenues could be delayed.

 

46

Risks Related to Our Business Operations and Industry

Failure to receive required quotas of controlled substances or comply with the Drug Enforcement Agency regulations, or the cost of compliance with these regulations, may adversely affect our business.

Our sufentanil-based products are subject to extensive regulation by the DEA, due to their status as scheduled drugs. Sufentanil is classified as a Schedule II controlled substance, considered to present a high risk of abuse. The manufacture, shipment, storage, sale and use of controlled substances are subject to a high degree of regulation, including security, record-keeping and reporting obligations enforced by the DEA and also by comparable state agencies. In addition, our contract manufacturers are required to maintain relevant licenses and registrations. This high degree of regulation can result in significant compliance costs, which may have an adverse effect on the commercialization of DSUVIA.

The DEA limits the availability and production of all Schedule II controlled substances, including sufentanil, through a quota system. The DEA requires substantial evidence and documentation of expected legitimate medical and scientific needs before assigning quotas to manufacturers. Our contract manufacturers apply for quotas on our behalf. We will need significantly greater amounts of sufentanil to successfully commercialize DSUVIA and to support Aguettant’s European commercialization of DZUVEO. Any delay by the DEA in establishing the procurement quota, reduction in our quota for sufentanil, failure to increase our quota over time to meet anticipated increases in demand, or refusal by the DEA to establish the procurement quota could delay or stop the commercial sale of DSUVIA. This, in turn, could have a material adverse effect on our business, results of operations, financial condition and prospects.

60

 

Our relationships with clinical investigators, health care professionals, consultants, commercial partners, third-party payers, hospitals, and other customers are subject to applicable anti-kickback, fraud and abuse and other healthcare laws, which could expose us to significant penalties.

 

Healthcare providers, including physicians, and others play a primary role in the recommendation and prescribing of any products for which we may obtain marketing approval. Our business operations and arrangements with investigators, healthcare professionals, consultants, commercial partners, hospitals, third-party payers and customers may expose us to broadly applicable fraud and abuse and other healthcare laws. These laws may constrain the business or financial arrangements and relationships through which we research, market, sell and distribute the products for which we obtain marketing approval. Applicable federal and state healthcare laws include, but are not limited to, the following:

 

 

the federal healthcare Anti-Kickback Statute, which prohibits, among other things, persons or entities from knowingly and willfully soliciting, offering, receiving or paying any remuneration (including any kickback, bribe, or rebate), directly or indirectly, overtly or covertly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, lease, order or recommendation of, any good, facility, item or service, for which payment may be made, in whole or in part, under federal healthcare programs such as Medicare and Medicaid;

 

the federal civil and criminal false claims laws, which prohibit, among other things, individuals or entities from knowingly presenting, or causing to be presented, to the federal government, claims for payment or approval that are false or fraudulent or from knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government;

 

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which, among other things, imposes criminal liability for knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program or to obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payer (e.g., public or private) and knowingly or willfully falsifying, concealing, or covering up by any trick or device a material fact or making any materially false statement in connection with the delivery of, or payment for, healthcare benefits, items or services relating to healthcare matters;

 

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or HITECH, and their implementing regulations, which impose certain obligations, including mandatory contractual terms, on covered healthcare providers, health plans and clearinghouses, and their respective business associates that perform services for them that involve the use, or disclosure of, individually identifiable health information, as well as their covered subcontractors with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

 

foreign laws, regulations, standards and regulatory guidance which govern the collection, use, disclosure, retention, security and transfer of personal data, including the European Union General Data Privacy Regulation, or GDPR, which introduces strict requirements for processing personal data of individuals within the European Union;

 

the federal transparency law, enacted as part of the Affordable Care Act, and its implementing regulations, which requires certain manufacturers of drugs, devices, biologicals and medical supplies to report annually to the CMS information related to payments and other transfers of value provided to physicians, (defined to include, doctors, dentists, optometrists, podiatrists and chiropractors), other healthcare professionals (such as physician assistants and nurse practitioners), and teaching hospitals, as well as ownership and investment interests held by physicians and their immediate family members;

 

analogous state laws that may apply to our business practices, including but not limited to, state laws that require pharmaceutical companies to implement compliance programs and/or comply with the pharmaceutical industry’s voluntary compliance guidelines; state laws that impose restrictions on pharmaceutical companies’ marketing practices and require manufacturers to track and file reports relating to pricing and marketing information, which requires tracking and reporting gifts, compensation and other remuneration and items of value provided to healthcare professionals and entities, state and local laws that require the registration of pharmaceutical sales representatives, and state laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways, with differing effects; and

 

the federal Foreign Corrupt Practices Act of 1977, United Kingdom Bribery Act 2010 and other similar anti-bribery laws in other jurisdictions which generally prohibit companies and their intermediaries from providing money or anything of value to officials of foreign governments, foreign political parties, or international organizations with the intent to obtain or retain business or seek a business advantage.

47

 

Recently, there has been a substantial increase in anti-bribery law enforcement activity by U.S. regulators, with more frequent and aggressive investigations and enforcement proceedings by both the Department of Justice and the SEC. A determination that our operations or activities are not, or were not, in compliance with United States or foreign laws or regulations could result in the imposition of substantial fines, interruptions of business, loss of supplier, vendor or other third-party relationships, termination of necessary licenses and permits, and other legal or equitable sanctions. Other internal or government investigations or legal or regulatory proceedings, including lawsuits brought by private litigants, may also follow as a consequence.

 

Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws involve substantial costs. It is possible that governmental authorities will conclude that our or our partners’ business practices may not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws. If our operations are found to be in violation of any of these or any other healthcare regulatory laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, contractual damages, reputational harm, increased losses and diminished profits, additional oversight and reporting obligations if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations any of which could adversely affect our ability to operate our business and our financial results. Any action against us for violation of these laws, even if we successfully defend against it, could cause us to incur significant legal expenses or divert our management’s attention from the operation of our business.

61

 

Significant disruptions of our information technology systems or data security incidents could result in significant financial, legal, regulatory, business and reputational harm to us.

 

We are increasingly dependent on information technology systems and infrastructure, including mobile technologies, to operate our business. In the ordinary course of our business, we collect, store, process and transmit large amounts of sensitive information, including intellectual property, proprietary business information, personal information and other confidential information. It is critical that we do so in a secure manner to maintain the confidentiality, integrity and availability of such sensitive information. We have also outsourced elements of our operations (including elements of our information technology infrastructure) to third parties, and as a result, we manage a number of third-party vendors who may or could have access to our computer networks or our confidential information. In addition, many of those third parties in turn subcontract or outsource some of their responsibilities to third parties. While all information technology operations are inherently vulnerable to inadvertent or intentional security breaches, incidents, attacks and exposures, the accessibility and distributed nature of our information technology systems, and the sensitive information stored on those systems, make such systems potentially vulnerable to unintentional or malicious internal and external attacks on our technology environment. Potential vulnerabilities can be exploited from inadvertent or intentional actions of our employees, third-party vendors, business partners, or by malicious third parties. Attacks of this nature are increasing in their frequency, levels of persistence, sophistication and intensity, and are being conducted by sophisticated and organized groups and individuals with a wide range of motives (including, but not limited to, industrial espionage) and expertise, including organized criminal groups, “hacktivists,” nation states and others. In addition to the extraction of sensitive information, such attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the confidentiality, integrity and availability of information. In addition, the prevalent use of mobile devices increases the risk of data security incidents.

 

Significant disruptions of our third-party vendors’ and/or business partners’ information technology systems or other similar data security incidents could adversely affect our business operations and result in the loss, misappropriation, and/or unauthorized access, use or disclosure of, or the prevention of access to, sensitive information, which could result in financial, legal, regulatory, business and reputational harm to us. In addition, information technology system disruptions, whether from attacks on our technology environment or from computer viruses, natural disasters, terrorism, war and telecommunication and electrical failures, could result in a material disruption of our development programs and our business operations. For example, the loss of clinical trial data from completed or future clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data.

 

48

There is no way of knowing with certainty whether we have experienced any data security incidents that have not been discovered. While we have no reason to believe this to be the case, attackers have become very sophisticated in the way they conceal access to systems, and many companies that have been attacked are not aware that they have been attacked. Any event that leads to unauthorized access, use or disclosure of personal information, including but not limited to personal information regarding our patients or employees, could disrupt our business, harm our reputation, compel us to comply with applicable federal and state breach notification laws and foreign law equivalents, subject us to time consuming, distracting and expensive litigation, regulatory investigation and oversight, mandatory corrective action, require us to verify the correctness of database contents, or otherwise subject us to liability under laws, regulations and contractual obligations, including those that protect the privacy and security of personal information. This could result in increased costs to us, and result in significant legal and financial exposure and/or reputational harm. In addition, any failure or perceived failure by us or our vendors or business partners to comply with our privacy, confidentiality or data security-related legal or other obligations to third parties, or any further security incidents or other inappropriate access events that result in the unauthorized access, release or transfer of sensitive information, which could include personally identifiable information, may result in governmental investigations, enforcement actions, regulatory fines, litigation, or public statements against us by advocacy groups or others, and could cause third parties, including clinical sites, regulators or current and potential partners, to lose trust in us or we could be subject to claims by third parties that we have breached our privacy- or confidentiality-related obligations, which could materially and adversely affect our business and prospects. Moreover, data security incidents and other inappropriate access can be difficult to detect, and any delay in identifying them may lead to increased harm of the type described above. While we have implemented security measures intended to protect our information technology systems and infrastructure, there can be no assurance that such measures will successfully prevent service interruptions or security incidents.

62

 

Business interruptions could delay our operations and sales efforts.

 

Our headquarters is located in the San Francisco Bay Area, near known earthquake fault zones and is vulnerable to significant damage from earthquakes. Our contract manufacturers, suppliers, clinical trial sites and local and national transportation vendors are all subject to business interruptions due to weather, outbreaks of pandemic diseases, natural disasters, or man-made incidents. We are also vulnerable to other types of natural disasters and other events that could disrupt our operations. If any of these events occurred and prevented us or third parties on which we rely from using all or a significant portion of our or their facilities, it may be difficult or, in certain cases, impossible for us to continue our business and operations for a substantial period of time.

 

We do not carry insurance for earthquakes or other natural disasters, and we may not carry sufficient business interruption insurance to compensate us for losses that may occur. Any losses or damages we incur could have a material adverse effect on our business operations.

 

Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel.

 

We are highly dependent on principal members of our executive team, the loss of whose services may adversely impact the achievement of our objectives. While we have entered into offer letters with each of our executive officers, any of them could leave our employment at any time, as all of our employees are “at will” employees. Recruiting and retaining qualified scientific, manufacturing, and commercial personnel will also be critical to our success. We may not be able to attract and retain these personnel on acceptable terms given the competition among numerous pharmaceutical and biotechnology companies for similar personnel. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. There is currently a shortage of skilled executives in our industry, which is likely to continue. As a result, competition for skilled personnel is intense and the turnover rate can be high. In addition, failure to succeed in clinical trials, or delays in the regulatory approval process, may make it more challenging to recruit and retain qualified personnel. The inability to recruit or loss of the services of any executive or key employee might impede the progress of our research, development and commercialization objectives.

 

We may fail to realize the benefits expected from our acquisition of Lowell, which could adversely affect our stock price.

Our acquisition of Lowell is our largest acquisition to date. The anticipated benefits we expect from this acquisition are, necessarily, based on projections and assumptions about the combined businesses of our company and Lowell, which may not materialize as expected or which may prove to be inaccurate. The value of our common stock could be adversely affected if we are unable to realize the anticipated benefits from the acquisition on a timely basis or at all. Achieving the benefits of the acquisition of Lowell will depend, in part, on our ability to integrate the business, operations and products of Lowell successfully and efficiently with our business. The challenges involved in this integration include, but are not limited to, (i) difficulties entering new markets and integrating new product candidates with which we have no or limited direct prior experience; and (ii) successfully managing relationships with our combined supplier base.

The financial results of the combined company may be adversely affected by cash expenses and non-cash accounting charges incurred in connection with our integration of the business and operations of Lowell. The amount and timing of these possible charges are not yet known. Further, our failure to identify or accurately assess the magnitude of certain liabilities we assumed in the acquisition could result in unexpected litigation or regulatory exposure, unfavorable accounting charges, unexpected increases in taxes due, a loss of anticipated tax benefits or other adverse effects on our business, operating results or financial condition. The price of our common stock could decline to the extent the combined company’s financial results are materially affected by any of these events.

We may acquire companies, product candidates or products or engage in strategic transactions, which could divert our managements attention and cause us to incur various costs and expenses.

 

We may acquire or invest in companies, product candidates or products that we believe could complement or expand our business or otherwise offer growth opportunities. The pursuit of potential acquisitions or investments may divert the attention of management and has caused, and in the future may cause, us to incur various costs and expenses in identifying, investigating, and pursuing them, whether or not they are consummated. We may not be able to identify desirable acquisitions or investments or be successful in completing or realizing anticipated benefits from such transactions. In addition, the acquisition of product candidates and products is a highly competitive area, and many other companies are pursuing the same or similar product candidates to those that we may consider attractive. Larger companies with more well-established and diverse revenue streams may have a competitive advantage over us due to their size, financial resources and more extensive clinical development and commercialization capabilities.

 

In addition, we receive inquiries relating to potential strategic transactions, including collaborations, licenses, and acquisitions. Such potential transactions may divert the attention of management and may cause us to incur various costs and expenses in investigating and evaluating such transactions, whether or not they are consummated.

 

6349

 

We face potential product liability claims, and, if such claims are successful, we may incur substantial liability.

 

CommercialOur past sales of DSUVIA/DZUVEO expose us to the risk of product liability claims. Product liability claims might be brought against us by patients, health care providers, pharmaceutical companies or others selling or otherwise coming into contact with our products. If we cannot successfully defend against product liability claims, we could incur substantial liability and costs. In addition, regardless of merit or eventual outcome, product liability claims may result in:

 

 

impairment of our business reputation;

 

costs due to related litigation;

 

distraction of management’s attention from our primary business;

 

substantial monetary awards to patients or other claimants;

 

the inability to commercialize our products; and

 

decreased demand for our products.

 

Our current product liability insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. In addition, our current product liability insurance contains an exclusion related to any claims related to our products from a governmental body, or payer, or those claims arising from a multi-plaintiff action for bodily injury or property damage. Multi-plaintiff claims caused by product defects are covered. This exclusion does not apply to any bodily injury claim related to our products made by an individual. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated adverse effects. A successful product liability claim, or series of claims, brought against us could cause our stock price to decline and, if judgments are excluded from our insurance coverage or exceed our insurance coverage, could adversely affect our results of operations and business. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. There can be no assurance that such coverage will be adequate to protect us against any future losses due to liability.

 

Our employees, independent contractors, principal investigators, consultants, commercial partners and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading.

 

We are exposed to the risk that our employees, independent contractors, investigators, consultants, commercial partners and vendors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct that violates (1) regulations implemented by the FDA and similar foreign regulatory bodies; (2) laws requiring the reporting of true, complete and accurate information to such regulatory bodies; (3) healthcare fraud and abuse laws of the United States and similar foreign fraudulent misconduct laws; and (4) laws requiring the reporting of financial information or data accurately. The promotion, sales and marketing of healthcare items and services, as well as certain business arrangements in the healthcare industry are subject to extensive laws designed to prevent misconduct, including fraud, kickbacks, self-dealing and other abusive practices. These laws may restrict or prohibit a wide range of pricing, discounting, marketing, structuring and commission(s), certain customer incentive programs and other business arrangements generally. Activities subject to these laws also involve the improper use of information obtained in the course of patient recruitment for clinical trials. It is not always possible to identify and deter employee and other third-party misconduct. The precautions we take to detect and prevent inappropriate conduct may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws. If any such actions are instituted against us, and we are not successful in defending ourselves, those actions could have a significant impact on our business, including the imposition of significant civil, criminal and administrative penalties, damages, monetary fines, disgorgement, imprisonment, additional oversight and reporting obligations if we become subject to a corporate integrity agreement or similar agreements to resolve allegations of non-compliance with these laws, possible exclusion from participation in Medicare, Medicaid and other federal healthcare programs, contractual damages, reputational harm, diminished profits and future earnings, and curtailment of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

 

50

Risks Related to Our Intellectual Property

 

If we cannot defend our issued patents from third party claims or if our pending patent applications fail to issue, our business could be adversely affected.

 

To protect our proprietary technology, we rely on patents as well as other intellectual property protections including trade secrets, nondisclosure agreements, and confidentiality provisions. As of September 30, 2022, we are the owner of record of 94 issued patents worldwide drawn to AcelRx’s sufentanil sublingual tablets and related medication delivery devices. These issued patents include 18 patents that we have listed in the FDA’s Orange Book for DSUVIA, some of which have expiration dates that extend into 2031. These issued patents also include a European patent drawn to the DZUVEO device that has an expiration date that extends into 2036.

64

Because sufentanil is not a new chemical entity, potential regulatory (data) exclusivity periods for new formulation, dosage form and/or dosage strength sufentanil products in the United States is limited to three years under the Hatch-Waxman Act. While the FDA was not able to approve a 505(b)(2) NDA or an abbreviated new drug application, or ANDA, using DSUVIA as its reference listed drug prior to November 2, 2021, we may now be subject to a third party’s Paragraph IV or other patent certification based on the patents we have listed in the FDA’s Orange Book for DSUVIA and engage in litigation against such a 505(b)(2) or ANDA applicant at any time.

In addition, weWe are pursuing a number of U.S. patent applications and foreign national applications directed to DSUVIA, Niyad, and LTX-608. The patent applications that we have filed and have not yet been granted may fail to result in issued patents in the United States or in foreign countries. Even if the patents do successfully issue, third parties may challenge the patents. We have entered into the DSUVIA Agreement with Alora pursuant to which Alora acquired all patents and trademarks related to DSUVIA and DZUVEO. In addition, we and Alora entered into an intellectual property agreement pursuant to which Alora granted fully-paid, royalty-free and perpetual licenses to us under certain specified intellectual property rights acquired by Alora under the DSUVIA Agreement for, among other things, the development, manufacture, commercialization and exploitation of certain products, including Zalviso.

 

As we continue to develop our product candidates ephedrine,Fedsyra, phenylephrine, Niyad and LTX-608, we generally expect to pursue 505(b)(2) NDA application pathways since allwith the exception of the base pharmacological agents are notfirst LTX-608 application which we expect to be treated as a new chemical entities.entity. As a result of thisthese filing avenue,avenues, we will need to include patent certifications regarding the reference listed drugs that our 505(b)(2) applications are based upon. These patent certifications could trigger patent litigation by the patent holders that we have certified against.

 

Our commercial success will depend in part on successfully defending our current patents against third party challenges and expanding our existing patent portfolio to provide additional layers of patent protection, as well as extending patent protection. There can be no assurance that we will be successful in defending our existing and future patents against third party challenges, or that our pending patent applications will result in additional issued patents.

 

The patent positions of pharmaceutical companies, including ours, can be highly uncertain and involve complex and evolving legal and factual questions. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States. Legal developments may preclude or limit the scope of available patent protection.

 

There is also no assurance that any patents issued to us will not become the subject of adversarial or post-issuance proceedings such as opposition, inter partes review, post-grant review, ex parte re-examination or other post-issuance proceedings. In addition, there is no assurance that the relevant patent office court or agency in such adversarial proceedings would not make unfavorable decisions, such as reducing the scope of a patent of ours, invalidating issued claims or determining that a patent of ours is invalid or unenforceable. There is also no assurance that any patents issued to us will provide us with competitive advantages, will not be challenged by any third parties, or that the patents of others will not prevent the commercialization of products incorporating our technology. Furthermore, there can be no guarantee that others will not independently develop similar products, duplicate any of our products, or design around our patents.

 

Litigation involving patents, patent applications and other proprietary rights is expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing our products to market and interfere with our business.

 

Our commercial success depends in part on our not infringing patents or misappropriating trademarks or misappropriating other third-party intellectual property.property rights. Although we are not currently aware of litigation or other proceedings or third-party claims of intellectual property infringement or misappropriation related to DSUVIA or our product candidates, the pharmaceutical industry is especially prone to extensive litigation proceedings between competitors regarding their patents and other intellectual property rights.

 

As we enter our target markets, it is possible that competitors or other third parties will claim that our products and/or processes infringe or misappropriate their intellectual property rights. These third parties may have obtained and may in the future obtain patents covering products or processes that are similar to our products, or may include composition or method claims that encompass our technology, allowing them to assert that our continued use of our own technologies infringes such newly emerging patent rights.

 

In the event that a patent infringement claim is asserted against us, we may counter, as an affirmative defense, that we do not infringe the relevant patent claims, that the patent is invalid or otherwise unenforceable or any combination thereof. The strength of our defenses will depend on the patents asserted, the interpretation of those patents, and our ability to establish the invalidity of the asserted patents. However, we could be unsuccessful in advancing non-infringement, invalidity or unenforceability arguments in our defense. In the United States, issued patents enjoy a presumption of validity, and the party challenging the validity of a patent claim must present clear and convincing evidence of invalidity, which is a high burden of proof. Conversely, the patent owner need only prove infringement by a preponderance of the evidence, which is a lower burden of proof.

 

If a court in a final and non-appealable decision were to hold that we have infringed someone else’s valid patent claim, we could be prevented from using that third-party patented technology and may also be required to pay the owner of the patent for damages for past sales and need to seek license access to the patented technology for future sales. If we decide to pursue such a license to one or more of these patents, we may not be able to obtain a license on commercially reasonable terms, if at all, or the license we obtain may require us to pay substantial royalties or grant cross licenses to our patent rights. For example, if the relevant patent is owned by a competitor, that competitor may choose not to license patent rights to us. If we decide to develop alternative technology to avoid the third-party patent claims, we may not be able to do so in a timely or cost-effective manner, if at all.

 

6551

 

In addition, because patent applications remain unpublished for 18 months from their initial filing date and some applications may be afforded confidentiality during prosecution that can take years to issue, there may currently be pending applications that are unknown to us and that may later result in issued patents that could cover one or more of our products.

 

It is possible that we may in the future receive communications from competitors and other companies alleging that we may be infringing their patents, misappropriating their trade secrets or otherwise violating their intellectual property rights, where they may offer license access to such intellectual property or threaten litigation. In addition to patent infringement claims, third parties may assert copyright, trademark or other intellectual property rights against us. We may need to expend considerable resources to counter such claims and may not be successful in our defense. Our business may suffer if a finding of infringement or misappropriation is established.

 

It is difficult and costly to protect our proprietary rights, and we may not be able to ensure their protection.

 

The patent positions of pharmaceutical companies can be highly uncertain and involve complex legal and factual questions for which important legal principles remain unresolved. No consistent policy regarding the breadth of claims allowed in pharmaceutical patents has emerged to date in the United States. The pharmaceutical patent situation outside the United States is just as uncertain. Changes in either the patent laws or in interpretations of patent laws in the United States and other countries may diminish the value of our intellectual property estate.

 

We cannot predict the breadth of claims that may be allowed or enforced in the patents that may issue from the applications that we currently have pending, or may in the future file ourselves or acquire or license from third parties. Claims could be brought regarding the validity of our patents by third parties. Further, if any patent right that we obtain is deemed invalid and/or unenforceable, it could impact our ability to commercialize or partner our technology.

 

Competitors or third parties may infringe our patents. We may decide it is necessary to assert patent infringement claims against such entities, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that a patent of ours is not valid or is unenforceable, or that the third party’s technology does not in fact infringe upon our patents. An adverse determination of any litigation or defense proceedings could put one or more of our patents at risk of being invalidated or interpreted narrowly and could put our related pending patent applications at risk of not issuing. Litigation may fail and, even if successful, may result in substantial costs and be a distraction to our management. We may not be able to prevent misappropriation of our intellectual property rights, particularly in countries outside the United States where national laws and court systems are less robust, making patent rights more difficult to enforce, and very expensive to pursue. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential or sensitive information could be compromised by disclosure in the event of litigation. In addition, during the course of litigation there could be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a substantial adverse effect on the price of our common stock.

 

The degree of future protection for our proprietary rights is uncertain, and we cannot ensure that:

 

 

we were the first to make the inventions covered by each of our pending patent applications or issued patents;

 

our patent applications were filed before the inventions covered by each patent or patent application was published by a third-party;

 

we were the first to file patent applications for these inventions;

 

others will not independently develop similar or alternative technologies or duplicate any of our technologies;

 

any patents issued to us or our collaborators will provide a basis for commercially viable products, will provide us with any competitive advantages or will not be challenged by third parties; or

 

the patents of others will not have an adverse effect on our business.

 

If we do not adequately protect our intellectual property rights, competitors may be able to use our technologies and erode or negate any competitive advantage we may have, which could materially harm our business, negatively affect our position in the marketplace, limit our ability to commercialize DSUVIA/DZUVEO or any of our ephedrine,Fedsyra, phenylephrine, Niyad or LTX-608 product opportunities, if approved, and delay or render impossible our achievement of profitability.

52

 

We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.

 

We rely on trade secrets to protect our proprietary know-how and technological advances, especially where we do not believe patent protection is appropriate or obtainable. However, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our business partners, employees, consultants, outside scientific collaborators, sponsored researchers and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information without misappropriating our rights. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights. Failure to obtain or maintain trade secret protection could enable competitors to use our proprietary information to develop products that compete with our products or cause additional, material adverse effects upon our competitive business position.

66

 

Periodic maintenance fees, renewal fees, annuity fees and various other governmental fees on patents and applications will be due to be paid to the United States Patent and Trademark Office and various foreign governmental patent agencies in several stages over the lifetime of the patents and/or applications.

 

We have systems in place, including use of third-party vendors, to manage payment of periodic maintenance fees, renewal fees, annuity fees and various other patent and application fees. The United States Patent and Trademark Office, or the USPTO, and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. There are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. If this occurs, our competitors might be able to enter the market, which would have a material adverse effect on our business.

 

We may not be able to enforce our intellectual property rights throughout the world.

 

The laws of some foreign countries do not protect intellectual property rights to the same extent as the laws of the United States. Many companies have encountered significant problems in protecting and defending intellectual property rights in certain foreign jurisdictions. The legal systems of some countries, particularly developing countries, do not favor the enforcement of patents and other intellectual property protection, especially those relating to life sciences. This could make it difficult for us to stop the infringement of our patents or the misappropriation of our other intellectual property rights. For example, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties. In addition, many countries limit the enforceability of patents against third parties, including government agencies or government contractors. In these countries, patents may provide limited or no benefit.

 

Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business. Accordingly, our efforts to protect our intellectual property rights in such countries may be inadequate. Additionally, claims may be brought regarding the validity of our patents by third parties in the United States and foreign countries. In addition, changes in the law and legal decisions by courts in the United States and foreign countries may affect our ability to obtain adequate protection for our technology and the enforcement of our intellectual property rights.

 

We have not yet registered our trademarks in all our potential markets, and failure to secure those registrations could adversely affect our business.

 

We have registered our ACELRX mark in the United States, Canada, the EU and India. In November 2018, the FDA accepted the DSUVIA mark.India, and we have applied for registration of our Niyad and Fedsyra marks. Although we are not currently aware of any oppositions to or cancellations of our registered trademarks or pending applications, it is possible that one or more of the applications and/or registrations could be subject to rejection, opposition or cancellation aftercancellation. In addition, we will need to seek FDA approval to use Niyad and Fedsyra as part of future potential applications for marketing approval of the marks are registered.relevant developmental products. The registrations will be subject to use and maintenance requirements. It is also possible that we have not yet registered all of our trademarks in all of our potential markets, such as securing the registration of DSUVIA in Canada, and that there are names or symbols other than “ACELRX” that may be protectable marks for which we have not sought registration, and failure to secure those registrations could adversely affect our business. Opposition or cancellation proceedings may be filed against our trademarks and our trademarks may not survive such proceedings.

 

53

Risks Related to Ownership of Our Common Stock

 

The market price of our common stock has historically been and may continue to be highly volatile.

 

The trading price of our common stock has experienced significant volatility and is likely to be volatile in the future. For example, the closing price of our common stock ranged between $3.57$0.58 and $12.10$2.59 during the first ninesix months of 2022,ended June 30, 2023, and between $9.81$1.78 and $55.40$12.10 during the year ended December 31, 2021.2022. Our stock price could be subject to wide fluctuations in response to a variety of factors, including the following:

 

 

failure to successfully commercializereceive payments for the sale by Alora of DSUVIA in the United States, or to successfully develop and commercialize our product candidates in the United States;

 

inability to obtain additional funding needed to conduct our planned business operations;

 

the integration and performance of any assets or businesses we acquire;

 

our inability to develop and commercialize products and product candidates that we in-license;

 

uncertainties regarding the magnitude and duration of impacts we are experiencing due to COVID-19;

 

the perception of limited market sizes or pricing for our products;

 

safety issues;

67

 

adverse results or delays in future clinical trials;

 

changes in laws or regulations applicable to our products;

 

inability to obtain adequate product supply for our products, or the inability to do so at acceptable prices;

 

adverse regulatory decisions;

 

changes in the structure of the healthcare payment systems;

inability to maintain regulatory approval for DZUVEO in the European Union;

 

introduction of new products, services or technologies by our competitors;

 

failure to meet or exceed financial projections we provide to the public;

 

failure to meet or exceed the estimates and projections of the investment community;

 

decisions by our collaboration partners regarding market access, pricing, and commercialization efforts in countries where they have the right to commercialize our products;

 

failure to maintain our existing collaborations or enter into new collaborations;

 

the perception of the pharmaceutical industry generally, and of opioid manufacturers more specifically, by the public, legislatures, regulators and the investment community;

 

announcements of significant acquisitions, strategic partnerships, joint ventures, or other significant transactions, including disposition transactions, or capital commitments by us or our competitors;

 

disputes or other developments relating to employment matters, business development efforts, proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

 

additions or departures of key management or scientific personnel;

 

costs associated with potential governmental investigations, inquiries, regulatory actions or lawsuits that may be brought against us as a result of us being an opioid manufacturer;

 

other types of significant lawsuits, including patent, stockholder, securities class action and derivative litigation;

 

changes in the market valuations of similar companies;

 

sales of our common stock by us or our stockholders in the future;

 

our ability to maintain compliance with Nasdaq listing requirements;

 

liquidity of our common stock; and

 

trading volume of our common stock.

 

In addition, the stock market in general, and The Nasdaq Global Market, or Nasdaq, in particular, have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors may negatively affect the market price of our common stock, regardless of our actual operating performance.

 

54

If we cannot maintain compliance with Nasdaqs continued listing requirements, our common stock may bedelistedfrom TheNasdaqGlobal Market.

In order to maintain our listing on Nasdaq, we are required to comply with the Nasdaq requirements, which includes maintaining a minimum bid price and a minimum public float. In particular, we are required to maintain a minimum bid price of $1.00 per share. On April 26, 2023, we received a notice from Nasdaq stating that we were not in compliance with Nasdaq Listing Rule 5450(a)(1) (the “Minimum Bid Price Rule”) because our common stock failed to maintain a minimum closing bid price of $1.00 for 30 consecutive business days. This notice had no immediate effect on the Nasdaq listing or trading of our common stock. On June 15, 2023, we received notice from Nasdaq confirming that we had cured the bid price deficiency and regained compliance with the Minimum Bid Price Rule, and that this matter is now closed; however, we cannot assure you that we will be able to maintain compliance with the Nasdaq continued listing requirements.

Without a Nasdaq market listing, stockholders may have a difficult time getting a quote for the sale or purchase of our common stock, the sale or purchase of our common stock would likely be made more difficult and the trading volume and liquidity of our common stock could decline. Delisting from Nasdaq could also result in negative publicity and could also make it more difficult for us to raise additional capital. The absence of such a listing may adversely affect the acceptance of our common stock as currency or the value accorded by other parties. Further, if we are delisted, we would also incur additional costs under state blue sky laws in connection with any sales of our securities. These requirements could severely limit the market liquidity of our common stock and the ability of our stockholders to sell our common stock in the secondary market. If our common stock is delisted by Nasdaq, our common stock may be eligible to trade on an over-the-counter quotation system, such as the OTCQB market, where an investor may find it more difficult to sell our common stock or obtain accurate quotations as to the market value of our common stock. We cannot assure you that our common stock, if delisted from Nasdaq, will be listed on another national securities exchange or quoted on an over-the counter quotation system. If our common stock is delisted, it may come within the definition of “penny stock” as defined in the Exchange Act, and would be covered by Rule 15g-9 of the Exchange Act. That Rule imposes additional sales practice requirements on broker-dealers who sell securities to persons other than established customers and accredited investors. For transactions covered by Rule 15g-9, the broker-dealer must make a special suitability determination for the purchaser and receive the purchaser’s written agreement to the transaction prior to the sale. Consequently, Rule 15g-9, if it were to become applicable, would affect the ability or willingness of broker-dealers to sell our securities, and accordingly would affect the ability of stockholders to sell their securities in the public market. These additional procedures could also limit our ability to raise additional capital in the future. 

Sales of a substantial number of shares of our common stock in the public market by us or our stockholders could cause our stock price to fall.

 

Because we will continue to need additional capital in the future to continue to expand our business and our research and development activities, among other things, we may conduct additional equity offerings. For example, under the universal shelf registration statement filed by us in June 2020 and declared effective by the SEC in July 2020, we may offer and sell any combination of common stock, preferred stock, debt securities and warrants in one or more offerings, up to a cumulative value of $150 million. To date, we have approximately $40.5$68.6 million (including shares that may be sold under the ATM Agreement with Cantor) remaining under such universal shelf registration statement.statement; however, our ability to sell securities under the shelf registration statement will be limited until we are no longer subject to the SEC's "baby shelf" limitations. Sales of a substantial number of shares of our common stock in the public market or the perception that these sales might occur, could depress the market price of our common stock and could impair our ability to raise capital through the sale of additional equity securities. Our management is authorized to grant stock options and other equity-based awards to our employees, directors and consultants under our equity incentive plans. Grants under our equity incentive plans may also cause our stockholders to experience additional dilution, which could cause our stock price to fall. In addition, in AprilMay 2022 we filed a resale registration statement to permit the former stockholders of Lowell to sell the shares of common stock we issued such stockholders in exchange for their shares of Lowell capital stock. In addition, in November 2022 we filed a resale registration statement to permit Lincoln Park Capital Fund, LLC to sell the shares of common stock that are issuable upon conversion of the Series A Redeemable Convertible Preferred Stock and that are issuable upon exercise of the warrant, which were issued in a private placement transaction in August 2022. We may in the future issue additional shares of our common stock as consideration in mergers, acquisitions and other business development transactions. We are unable to predict the effect that sales may have on the prevailing market price of our common stock. All of our shares of common stock outstanding are eligible for sale in the public market, subject in some cases to the volume limitations and manner of sale requirements of Rule 144 under the Securities Act. Sales of stock by our stockholders could have a material adverse effect on the trading price of our common stock.

 

6855

We previously identified a material weakness in our internal control over financial reporting. In the future, we may identify additional material weaknesses or otherwise fail to maintain an effective system of internal control over financial reporting or adequate disclosure controls and procedures, which may result in material errors in our financial statements or cause us to fail to meet our period reporting obligations.

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, evaluating the effectiveness of our internal controls and disclosing any changes or material weaknesses identified through such evaluation. A material weakness is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of our annual or interim financial statements will not be prevented or detected on a timely basis.

During the preparation of our consolidated financial statements for the year ended December 31, 2022, we identified an error within our earnings per share calculation for the three and six months ended June 30, 2022, and the nine months ended September 30, 2022, whereby we did not properly apply the two-class method of calculating earnings per share with respect to the warrants issued in November 2021. Our management subsequently concluded that a material weakness existed and our internal control over financial reporting was not effective as of June 30, 2022.

As a result, we determined that there were material errors in the financial statements that required a restatement of the unaudited condensed consolidated financial statements included in our Forms 10-Q for the quarterly periods ended June 30, 2022 and September 30, 2022. This was due to the inadequate design and implementation of controls related to the technical accounting review and analysis over earnings per share calculations which were insufficient to prevent or detect errors in the calculation. Specifically, the error was due to management’s failure to identify warrants issued in November 2021 as participating securities and consequently attribute earnings to these securities as part of a two-class EPS calculation.

While we believe we have fully remediated the material weakness related to the technical accounting review and analysis over earnings per share calculations as of June 30, 2023, any failure to maintain effective internal control over financial reporting in the future, or failure to remediate any future material weakness, could adversely impact our ability to report our financial position and results of operations on a timely and accurate basis.

Effective internal controls over financial reporting are necessary for us to provide reliable financial reports and, together with adequate disclosure controls and procedures, are designed to prevent fraud. Any failure to implement required new or improved controls, or difficulties encountered in their implementation, could cause us to fail to meet our reporting obligations. If we are not able to comply with the requirements of the Sarbanes-Oxley Act or if we are unable to maintain effective internal control over financial reporting, we may not be able to produce timely and accurate financial statements or guarantee that information required to be disclosed by us in the reports that we file with the SEC, is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms. Any failure of our internal control over financial reporting or disclosure controls and procedures could cause our investors to lose confidence in our publicly reported information, cause the market price of our stock to decline, expose us to sanctions or investigations by the SEC or other regulatory authorities, or impact our results of operations.

 

We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.

 

We have never declared or paid any cash dividends on our capital stock, and we are prohibited from doing so under the terms of the Loan Agreement. Regardless of the restrictions in the Loan Agreement or the terms of any potential future indebtedness, we anticipate that we will retain all available funds and any future earnings to support our operations and finance the growth and development of our business and, therefore, we do not expect to pay cash dividends in the foreseeable future. Any future determination related to our dividend policy will be made at the discretion of our Board of Directors and will depend on then-existing conditions, including our financial condition, operating results, contractual restrictions, capital requirements, business prospects and other factors our Board of Directors may deem relevant.

 

Provisions in our amended and restated certificate of incorporation and bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management.

 

Some provisions of our charter documents and Delaware law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management. These provisions include:

 

 

authorizing the issuance of “blank check” preferred stock, the terms of which may be established and shares of which may be issued without stockholder approval;

 

limiting the removal of directors by the stockholders;

 

a staggered Board of Directors;

56

 

prohibiting stockholder action by written consent, thereby requiring all stockholder actions to be taken at a meeting of our stockholders;

 

eliminating the ability of stockholders to call a special meeting of stockholders; and

 

establishing advance notice requirements for nominations for election to our Board of Directors or for proposing matters that can be acted upon at stockholder meetings.

 

These provisions may frustrate or prevent any attempts by our stockholders to replace or remove our current management by making it more difficult for stockholders to replace members of our Board of Directors, which is responsible for appointing the members of our management. In addition, we are subject to Section 203 of the Delaware General Corporation Law, which generally prohibits a Delaware corporation from engaging in any of a broad range of business combinations with an interested stockholder for a period of three years following the date on which the stockholder became an interested stockholder, unless such transactions are approved by our Board of Directors. This provision could have the effect of delaying or preventing a change of control, whether or not it is desired by or beneficial to our stockholders. Further, other provisions of Delaware law may also discourage, delay or prevent someone from acquiring us or merging with us.

 

Risks of a General Nature

 

Litigation may substantially increase our costs and harm our business.

 

We have been, are, and may in the future become, party to lawsuits including, without limitation, actions and proceedings in the ordinary course of business relating to our directors, officers, stockholders, intellectual property rights, employment matters and the safety or efficacy of our products, which will cause us to incur legal fees and other costs related thereto, including potential expenses for the reimbursement of legal fees of officers and directors under indemnification obligations. The expense of defending against such litigation may be significant and there can be no assurance that we will be successful in any defense. Further, the amount of time that may be required to resolve such lawsuits is unpredictable, and these actions may divert management’s attention from the day-to-day operations of our business, which could adversely affect our business, results of operations, and cash flows. Our insurance carriers may deny coverage, may be inadequately capitalized to pay on valid claims, or our policy limits may be inadequate to fully satisfy any damage awards or settlements. If this were to happen, the payment of any such awards could have a material adverse effect on our consolidated operations, cash flows and financial position. Additionally, any such claims, whether or not successful, could damage our reputation and business. Litigation is subject to inherent uncertainties, and an adverse result in such matters that may arise from time to time could have a material adverse effect on our business, results of operations, and financial condition. Please see Note 106 to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information about pending legal proceedings.

69

 

Our involvement in securities-related class action litigation could divert our resources and management's attention and harm our business.

 

The stock markets have from time-to-time experienced significant price and volume fluctuations that have affected the market prices for the common stock of pharmaceutical companies. These broad market fluctuations may cause the market price of our common stock to decline. In addition, the market price of our common stock may vary significantly based on AcelRx-specific events, such as receipt of Complete Response Letters, Warnings Letters, such as the Warning Letter we received from the FDA on February 11, 2021, negative clinical results, a negative vote or decision by an FDA advisory committee, or other negative feedback from the FDA, EMA, or other regulatory agencies. In the past, securities-related class action litigation has often been brought against a company following a decline in the market price of its securities. This risk is especially relevant for us because biotechnology and biopharmaceutical companies often experience significant stock price volatility in connection with their investigational drug candidate development programs and the FDA'sFDA’s review of their NDAs. Following receipt of the FDA’s Warning Letter, a securities class action complaint was filed against us and two of our officers on June 8, 2021 in the United States District Court for the Northern District of California. The amended securities class action complaint, which was filed on March 7, 2022, named a third officer as a defendant. On September 28, 2022, the Court issued a formal written opinion, or the First Opinion, dismissing all of the plaintiff’s claims against the Company and the named defendants. Plaintiffs have been granted 60 daysdefendants with leave for plaintiffs to amend their complaint. On November 28, 2022 the plaintiffs filed their second amended complaint. On July 7, 2023, the Court issued a formal written opinion, or the Second Opinion, dismissing all of the plaintiff’s claims against the Company and the named defendants with leave for plaintiffs to amend their complaint in part and resubmit on or before November 28, 2022.without leave to amend in part. The plaintiff’s deadline to file a third amended complaint is September 5, 2023. On July 6, 2021, September 30, 2021, October 26, 2021 and November 17, 2021, four purported shareholder derivative complaints were filed in the United States District Court for the Northern District of California asserting state and federal claims based on the same alleged misstatements as the securities class action complaint. On December 6, 2021, the Court entered an order consolidating all four actions and staying the consolidated action pending the outcome of any motion to dismiss the securities class action. Please refer to Note 106 to the unaudited condensed consolidated financial statements in this Quarterly Report on Form 10-Q for additional information about these pending legal proceedings. Securities-related class action litigation often is expensive and diverts management'smanagement’s attention and our financial resources, which could harm our business. Additional lawsuits related to the pending litigation may follow. Moreover, if AcelRx experiences a decline in its stock price, we could face additional securities class action lawsuits.

 

57

Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited.

 

As of December 31, 2021,2022, we had federal net operating loss carryforwards of $308.5$346.4 million, of which $114.9 million federal net operating losses generated before January 1, 2018 will begin to expire in 2029. Federal$231.5 million of such federal net operating losses of $193.6 millionwere generated after January 1, 2018 will carryforward indefinitely but are subject to the 80% taxable income limitation.December 31, 2017. As of December 31, 2021,2022, we had state net operating loss carryforwards of $154.7$167.9 million, which begin to expire in 2028. Under current law, federal net operating losses generated in tax years beginning prior to January 1, 2018 generally will expire 20 years after they were generated if not used prior thereto; federal net operating losses generated in tax years beginning after December 31, 2017 will carryforward indefinitely, but the deductibility of such federal net operating losses generally is limited to 80% of current year taxable income. Many states have similar laws. Our ability to use our federal and state net operating losses to offset potential future taxable income and related income taxes that would otherwise be due is dependent upon our generation of future taxable income before the expiration dates of the net operating losses, and we cannot predict with certainty when, or whether, we will generate sufficient taxable income to use all of our net operating losses. Federal net operating losses generated prior to 2018 will continue to be governed by the net operating loss tax rules as they existed prior to the adoption of the Tax Cuts and Jobs Act of 2017, or Tax Act, which means that generally they will expire 20 years after they were generated if not used prior thereto. Many states have similar laws. Accordingly, our federal and state net operating losses could expire unused and be unavailable to offset future income tax liabilities. Under the newly enacted Tax Act as modified by CARES Act, federal net operating losses incurred in tax years beginning after December 31, 2017 and before January 1, 2021 may be carried back to each of the five tax years preceding such loss, and federal net operating losses arising in tax years beginning after December 31, 2020 may not be carried back. Moreover, federal net operating losses generated in tax years ending after December 31, 2017 may be carried forward indefinitely, but the deductibility of such federal net operating losses is limited to 80% of current year taxable income for tax years beginning after December 31, 2020.

In addition, under SectionSections 382 and 383 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state law, if a corporation undergoes an “ownership change,” generally defined as a greater than 50% change (by value) in its equity ownership over a three-year period, the corporation’s ability to use its pre-change net operating loss carryforwards and other pre-change tax attributes (such as research tax credits) to offset its post-change income may be limited. The completion of the July 2013 public equity offering, together with our public equity offering in December 2012, our initial public offering, private placements and other transactions that have occurred, have triggered such an ownership change. In addition, since we will need to raise substantialWe may experience additional funding to finance our operations, we may undergo further ownership changes as a result of subsequent shifts in our stock ownership, some of which may be outside of our control. Furthermore, our ability to utilize net operating losses of companies that we have acquired or may acquire in the future.future may be subject to limitations. In the future, if we earn net taxable income, our ability to use our pre-change net operating loss carryforwards or other tax attributes to offset United StatesU.S. federal taxable income may be subject to limitations, which could potentially result in increased future tax liability to us.us and could adversely affect our business, results of operations, and cash flows.

 

Our effective tax rate may fluctuate, we may be adversely affected by changes in tax laws and regulations, and we may incur obligations in tax jurisdictions in excess of accrued amounts.

 

We are subject to taxation in numerous U.S. statesfederal, state, and territories.local jurisdictions. As a result, our effective tax rate is derived from a combination of applicable tax rates in the various placesjurisdictions that we operate. In preparing our financial statements, we estimate the amount of tax that will become payable in each of such places.jurisdiction. Nevertheless, our effective tax rate may be different than experienced in the past due to numerous factors, including passage of the newly enacted federal income tax law, changes in the mix of our profitability from state to state,among the jurisdiction in which we operate, the results of examinations and audits of our tax filings, our inability to secure or sustain acceptable agreements with tax authorities, changes in accounting for income taxes and enactment of new tax laws. Or changes in the interpretation and application of existing tax laws. New income, sales, use or other tax laws, rules, regulations, or ordinances could be enacted at any time. For example, recent legislation commonly referred to as the Inflation Reduction Act imposes a one percent excise tax on share buybacks imposed on the corporation repurchasing such stock, effective for tax years beginning after December 31, 2022. Also, the Tax Act eliminated the option to currently deduct research and development expenditures in the year incurred, and instead requires taxpayers to capitalize and amortize U.S.-based and non-U.S.-based research and development expenditures over five and fifteen years, respectively. Although there has been proposed legislation that would defer the capitalization requirement to later years, we have no assurance that the provision will be repealed, deferred, or otherwise modified. Any of these factors could cause us to experience an effective tax rate significantly different from previous periods or our current expectations and may result in tax obligations in excess of amounts accrued in our financial statements.

 

Macroeconomic uncertainties, including inflationary pressures, supply chain disruptions, labor shortages, significant volatility in global markets, recession risks, and the COVID-19 pandemic have in the past and may continue to adversely affect our business, future results of operations, and financial condition, the effects of which remain uncertain.

Global economic and business activities continue to face widespread macroeconomic uncertainties, including inflation, supply chain disruptions, labor shortages, as well as recession risks, which may continue for an extended period. In addition, the mitigation measures we have taken in responses to the COVID-19 pandemic have represented a significant disruption in how we operate our business, including a loss of productivity. The operations of our partners, suppliers, and other third parties with whom we have a business relationship have likewise been disrupted. While our offices are now reopened, many of our employees who were hired remotely during the pandemic continue to work remotely and others are working on a hybrid basis. We do not currently have visibility on whether we may return to normal operations of having everyone work in office on a full-time basis. Our efforts to keep our offices open safely may not be successful and could expose our employees to health risks. If there are further waves or variants of the virus, we may need to further modify our business practices in a manner that may impact our business. If our employees are not able to perform their job duties due to illness or are unable to perform them as efficiently at home for an extended period of time, we may not be able to deliver on our business priorities, and we may experience an overall lower productivity of our workforce.

7058

The COVID-19 pandemic has already had an adverse effect on the global economy and our business. Actual and potential impacts include:

the ability of our employees to travel has been limited and we have altered, postponed, or canceled planned industry events or shifted them to a virtual only format, and we may continue to do so;

overall lower productivity of our workforce;

extreme volatility in financial and other capital markets as a result of concerns over the economic impact of the COVID-19 pandemic, which have in the past and may in the future adversely affect our stock price and our ability to access capital markets.

We continue to monitor the impact of the COVID-19 pandemic and there may be additional costs or impacts to our business and operations, including in connection with returning to our offices, if we return to normal operations of having everyone work in office on a full-time basis. In addition, there is no guarantee that a future outbreak of this or any other widespread epidemics will not occur, or that the global economy will recover, either of which could seriously harm our business. The potential long-term impact of the COVID-19 pandemic or a similar health epidemic on our business, operations, or the global economy as a whole remains uncertain. Accordingly, it remains difficult for us to predict the duration and extent to which this will affect our business, future results of operations, and financial condition at this time.

To the extent that macroeconomic uncertainties and the COVID-19 pandemic continue to harm our business, many of the other risks described in these risk factors may be exacerbated.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 


 

Item 6. Exhibits

 

    Incorporation By Reference
Exhibit
Number
 Exhibit Description 

Form

 

SEC
File No.

 

Exhibit

 

Filing Date

           

3.1

 

Amended and Restated Certificate of Incorporation of the Registrant.

 

8-K

 

001-35068

 

3.1

 

02/18/2011

           
3.2 Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant. 8-K 001-35068 3.1 06/25/2019
           

3.3

 

Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.

 

8-K

 

001-35068

 

3.1

 

10/25/2022

           

3.4

 

Certificate of Designations of Preferences, Rights and Limitations of Series A Convertible Preferred Stock of the Registrant.

 

8-K

 

001-35068

 

3.1

 

08/04/2022

           

3.5

 

Certificate of Elimination of Series A Convertible Preferred Stock of the Registrant.

 

8-K

 

001-35068

 

3.2

 

10/25/2022

           

3.6

 

Amended and Restated Bylaws of the Registrant.

 

8-K

 

001-35068

 

3.1

 

08/12/2022

           

10.1

 

Securities Purchase Agreement, between the Registrant and Lincoln Park Capital Fund, LLC, dated as of August 3, 2022.

 

8-K

 

001-35068

 

10.1

 

08/04/2022

           

10.2

 

Registration Rights Agreement, between the Registrant and Lincoln Park Capital Fund, LLC, dated as of August 3, 2022.

 

8-K

 

001-35068

 

10.2

 

08/04/2022

           

10.3

 

Warrant to Purchase Common Stock of the Registrant, dated as of August 3, 2022.

 

8-K

 

001-35068

 

4.1

 

08/04/2022

           

31.1

 Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 

 

      
           

31.2

 Certification of Principal Financial and Accounting Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended. 

 

      
           

32.1

 Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.* 

 

      
           

101.INS

 Inline XBRL Instance Document- the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document. 

 

      
           

101.SCH

 Inline XBRL Taxonomy Schema Document. 

 

      
           

101.CAL

 Inline XBRL Taxonomy Calculation Linkbase Document. 

 

      
           

101.DEF

 Inline XBRL Taxonomy Definition Linkbase Document. 

 

      
           

101.LAB

 Inline XBRL Taxonomy Label Linkbase Document. 

 

      
           

101.PRE

 Inline XBRL Taxonomy Presentation Linkbase Document. 

 

      
           

104

 Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, and 101.PRE). 

 

      
  Incorporation By Reference
Exhibit
Number
Exhibit Description

Form

 

SEC
File No.

 

Exhibit

 

Filing Date

         

3.1

Amended and Restated Certificate of Incorporation of the Registrant.

8-K         

 

001-35068

 

3.1         

 

02/18/2011         

         

3.2

Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.

8-K         

 

001-35068

 

3.1         

 

06/25/2019         

         

3.3

Certificate of Amendment of Amended and Restated Certificate of Incorporation of the Registrant.

8-K         

 

001-35068

 

3.1         

 

10/25/2022         

         

3.4

Amended and Restated Bylaws of the Registrant.

8-K         

 

001-35068

 

3.1         

 

08/12/2022         

         

10.1

Form of Series A common stock warrant (July 2023).

8-K         

 

001-35068

 

10.3         

 

07/21/2023         

         

10.2

Form of Series B common stock warrant (July 2023).

8-K         

 

001-35068

 

10.4         

 

07/21/2023         

         

10.3

Form of Pre-Funded Warrant (July 2023).

8-K         

 

001-35068

 

10.5         

 

07/21/2023         

         

10.4

Form of placement agent Series A common stock warrant.

8-K         

 

001-35068

 

10.6         

 

07/21/2023         

         

10.5

Form of placement agent Series B common stock warrant.

8-K         

 

001-35068

 

10.7         

 

07/21/2023         

         

10.6§

Form of Securities Purchase Agreement, between the Registrant and the Purchasers, dated July 17, 2023.

8-K         

 

001-35068

 

10.1         

 

07/21/2023         

         

10.7§

Form of Registration Rights Agreement, between the Registrant and the Purchasers, dated July 17, 2023.

8-K         

 

001-35068

 

10.2         

 

07/21/2023         

         

31.1

Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

 

      
         

31.2

Certification of Principal Financial and Accounting Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as amended.

 

      
         

32.1

Certifications of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.*

 

      

 


101.INS

Inline XBRL Instance Document- the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.

101.SCH

Inline XBRL Taxonomy Schema Document.

101.CAL

Inline XBRL Taxonomy Calculation Linkbase Document.

101.DEF

Inline XBRL Taxonomy Definition Linkbase Document.

101.LAB

Inline XBRL Taxonomy Label Linkbase Document.

101.PRE

Inline XBRL Taxonomy Presentation Linkbase Document.

104

Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101.INS, 101.SCH, 101.CAL, 101.DEF, 101.LAB, and 101.PRE).

§         Schedules omitted pursuant to Item 601(a)(5) of Regulation S-K. The Registrant agrees to furnish supplementally a copy of any omitted schedule upon request by the SEC.

*         The certifications attached as Exhibit 32.1 accompany this Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the Registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.  

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

Date: November 14, 2022August 10, 2023

AcelRx Pharmaceuticals, Inc.

 

(Registrant)

  
 

/s/    Raffi Asadorian

 

Raffi Asadorian

 

Chief Financial Officer

 

(Duly Authorized and Principal Financial and

Accounting Officer)

 

7361