UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒

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

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

For the quarterly period ended September 30, ~~2017~~2021

☐

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

☐~~TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934~~

For the transition period from to

Commission file number: 001-37372

A picture containing text, clipart

Description automatically generated

Collegium Pharmaceutical, Inc.

(Exact name of registrant as specified in its charter)

Virginia (State or other jurisdiction of incorporation or organization)		03-0416362 (I.R.S. Employer Identification Number)

~~780 Dedham Street, Suite 800~~100 Technology Center Drive ~~Canton,~~ Stoughton, MA (Address of principal executive offices)		~~02021~~02072 (Zip Code)

~~(781)~~ (781) 713-3699

(Registrant’s telephone number, including area code)

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


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	COLL	The NASDAQ Global Select 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 ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ 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 ~~and post~~ such files). Yes ☒⌧ No ☐◻

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See 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☐~~filer ◻		Accelerated filer ☒

Non-accelerated filer ☐◻ ~~(Do not check if a smaller reporting company)~~		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 Rule 12b-2 of the Exchange Act). Yes ☐ No ☒⌧

As of October 31, ~~2017,~~2021, there were ~~32,562,277~~34,568,709 shares of Common Stock, $0.001 par value per share, outstanding.

FORWARD-LOOKING STATEMENTS

Statements made in this Quarterly Report on Form 10-Q that are not statements of historical or current facts, such as those under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements discuss our current expectations and projections relating to our financial condition, results of operations, plans, objectives, future performance and business. These statements may be preceded by, followed by or include the words “aim,” “anticipate,” “believe,” “estimate,” “expect,” “forecast,” “intend,” “outlook,” “plan,” “potential,” “project,” “projection,” “seek,” “may,” “could,” “would,” “should,” “can,” “can have,” “likely,” the negatives thereof and other words and terms of similar meaning.

Forward-looking statements are inherently subject to risks, uncertainties and assumptions; they are not guarantees of performance. You should not place undue reliance on these statements. We have based these forward-looking statements on our current expectations and projections about future events. Although we believe that our assumptions made in connection with the forward-looking statements are reasonable, we cannot assure you that the assumptions and expectations will prove to be correct.

You should understand that the following important factors could affect our future results and could cause those results or other outcomes to differ materially from those expressed or implied in our forward-looking statements:

●

our ability to commercialize and grow sales of our products, particularly in light of current global challenges stemming from the COVID-19 pandemic;

●

our ability to obtain and maintain regulatory approval of our products, ~~and product candidates,~~ and any related restrictions, limitations, and/or warnings in the label of an approved product;

●

~~our plans to commercialize our product candidates and grow sales of our products;~~

the size ~~and growth potential~~ of the markets for our products, and ~~product candidates, and~~ our ability to service those markets;

●

the success of competing products that are or become available;

●

our ability to obtain and maintain reimbursement and third-party payor contracts with favorable terms for our products;

●

the costs of commercialization activities, including marketing, sales and distribution;

●

~~our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators;~~

the rate and degree of market acceptance of our ~~products and product candidates;~~

products;

●

changing market conditions for our ~~products and product candidates;~~

products;

●

the outcome of any patent infringement, opioid-related or other litigation that may be brought by or against us, including litigation with Purdue Pharma, L.P.;

●

the outcome of any governmental investigation related to the manufacture, marketing and sale of opioid medications;

●

the performance of our third-party suppliers and manufacturers;

●

our ability to secure adequate supplies of active pharmaceutical ingredients for each of our products, manufacture adequate quantities of commercially salable inventory and maintain our supply chain in the face of global challenges, such as the COVID-19 pandemic;

●

our ability to effectively manage our relationships with licensors and to commercialize products that we in-license from third parties;

●

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

●

~~the success, cost and timing of our product development activities, studies and clinical trials;~~

our ability to obtain funding for our ~~operations;~~

business development;

●

our ability to comply with the terms of our outstanding indebtedness;

●

regulatory and legislative developments in the United States, including the adoption of opioid stewardship and ~~foreign countries;~~

similar taxes that may impact our business;

●

~~our expectations regarding~~ our ability to obtain and ~~adequately~~ maintain sufficient intellectual property protection for our products and any product candidates;

●

~~our ability to operate our business without infringing the intellectual property rights of others;~~

~~the performance of our third-party suppliers and manufacturers;~~

our ability to comply with stringent ~~U.S. and foreign~~ government regulations relating to the ~~manufacture~~manufacturing and marketing of pharmaceutical products, including U.S. Drug Enforcement Agency ~~or DEA,~~(“DEA”) compliance;

●

~~the loss of key scientific or management personnel;~~

~~our expectations regarding the period during which we qualify as an emerging growth company under the JOBS Act;~~

our customer concentration, which may adversely affect our financial condition and results of operations; ~~and~~

●

the accuracy of our estimates regarding expenses, revenue, capital requirements and need for additional ~~financing.~~

financing; and

●

the other risks, uncertainties and factors discussed under the heading “Risk Factors” in this Quarterly Report on Form 10-Q.

In light of these risks and uncertainties, expected results or other anticipated events or circumstances discussed in this Quarterly Report on Form 10-Q (including the exhibits hereto) might not occur. We undertake no obligation, and specifically decline any obligation, to publicly update or revise any forward-looking statements, even if experience or future developments make it clear that projected results expressed or implied in such statements will not be realized, except as may be required by law.

These and other risks are described under the heading “Risk Factors” in our Annual Report on Form 10-K, filed with the United States Securities and Exchange Commission, or the SEC, on March 10, 2017 for the year ended December 31, 2016, or Annual Report, as revised and supplemented by those risks described from time to time in other reports which we file with the SEC, including in this Quarterly Report on Form 10-Q. Those factors and the other risk factors described therein are not necessarily all of the important factors that could cause actual results or developments to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors also could harm our results. Consequently, there can be no assurance that actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Given these uncertainties, prospective investors are cautioned not to place undue reliance on such forward-looking statements.

PART I—FINANCIAL INFORMATION

Item 1. Condensed Consolidated Financial Statements (Unaudited).

Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

September 30,

December 31,

2017

2016

Assets





Current assets

Cash and cash equivalents

$
107,611

$
153,225

Accounts receivable

5,823

2,129

Inventory

1,401

1,316

Prepaid expenses and other current assets

4,061

1,905

Total current assets

118,896

158,575

Property and equipment, net

1,632

1,038

Intangible assets, net

1,877

2,103

Restricted cash

97

97

Other long-term assets

171

204

Total assets

$
122,673

$
162,017

Liabilities and shareholders' equity (deficit)

Current liabilities

Accounts payable

$
4,982

$
9,106

Accrued expenses

19,268

8,879

Deferred revenue

—

4,944

Current portion of term loan payable

2,146

2,667

Total current liabilities

26,396

25,596

Lease incentive obligation

8

34

Term loan payable, long-term

—

1,479

Total liabilities

26,404

27,109

Commitments and contingencies (see Note 10)

Shareholders’ equity:

Preferred stock, $0.001 par value; authorized shares - 5,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - none at September 30, 2017 and December 31, 2016

—

—

Common stock, $0.001 par value; authorized shares - 100,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - 30,765,100 at September 30, 2017 and 29,364,100 at December 31, 2016

31

29

Additional paid-in capital

376,884

358,063

Accumulated deficit

(280,646)

(223,184)

Total shareholders’ equity

96,269

134,908

Total liabilities and shareholders’ equity

$
122,673

$
162,017


	September 30,		December 31,
	2021		2020
Assets
Current assets
Cash and cash equivalents	$	193,241	$	174,116
Accounts receivable, net		148,999		83,320
Inventory		17,358		15,614
Prepaid expenses and other current assets		3,640		4,838
Total current assets		363,238		277,888
Property and equipment, net		19,629		18,988
Operating lease assets		7,835		8,391
Intangible asset, net		285,518		335,904
Restricted cash		2,547		2,547
Deferred tax assets		63,026		—
Other noncurrent assets		10		123
Total assets	$	741,803	$	643,841
Liabilities and shareholders' equity
Current liabilities
Accounts payable	$	7,730	$	10,016
Accrued expenses		20,592		24,656
Accrued rebates, returns and discounts		191,723		156,554
Current portion of term notes payable		48,135		47,495
Current portion of operating lease liabilities		793		730
Total current liabilities		268,973		239,451
Term notes payable, net of current portion		73,832		110,019
Convertible senior notes		139,738		99,575
Operating lease liabilities, net of current portion		8,166		8,765
Total liabilities		490,709		457,810
Commitments and contingencies (see Note 14)
Shareholders’ equity:
Preferred stock, $0.001 par value; authorized shares - 5,000,000		—		—
Common stock, $0.001 par value; authorized shares - 100,000,000; 35,656,193 issued and 34,797,153 outstanding shares at September 30, 2021 and 34,612,054 at December 31, 2020		36		35
Additional paid-in capital		499,846		519,143
Accumulated deficit		(231,308)		(333,147)
Treasury stock, at cost; 859,040 shares at September 30, 2021 and NaN at December 31, 2020		(17,480)		—
Total shareholders’ equity		251,094		186,031
Total liabilities and shareholders’ equity	$	741,803	$	643,841

See accompanying notes to the ~~condensed consolidated financial statements.~~

Condensed Consolidated Financial Statements.

Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

Three months ended September 30,

Nine months ended September 30,

2017

2016

2017

2016

Product revenues, net
$
11,950

$
408

$
17,682

$
408

Costs and expenses

Cost of product revenues

553

29

1,501

29

Research and development

2,069

3,254

6,378

11,617

Selling, general and administrative

22,758

23,567

67,667

55,266

Total costs and expenses

25,380

26,850

75,546

66,912

Loss from operations

(13,430)

(26,442)

(57,864)

(66,504)

Interest income (expense), net

167

(2)

402

(113)

Net loss
$
(13,263)

$
(26,444)

$
(57,462)

$
(66,617)

Loss per share - basic and diluted
$
(0.45)

$
(1.13)

$
(1.95)

$
(2.85)

Weighted-average shares - basic and diluted

29,753,043

23,460,340

29,517,396

23,334,558


	Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020
Product revenues, net	$	78,843	$	79,176	$	249,506	$	233,745
Cost of product revenues
Cost of product revenues (excluding intangible asset amortization)		15,934		14,188		47,170		54,316
Intangible asset amortization		16,796		16,795		50,386		43,885
Total cost of products revenues		32,730		30,983		97,556		98,201
Gross profit		46,113		48,193		151,950		135,544
Operating expenses
Research and development		1,450		2,141		7,842		7,300
Selling, general and administrative		30,514		26,426		92,358		87,008
Total operating expenses		31,964		28,567		100,200		94,308
Income from operations		14,149		19,626		51,750		41,236
Interest expense		(5,115)		(8,063)		(16,257)		(21,145)
Interest income		3		3		9		229
Income before income taxes		9,037		11,566		35,502		20,320
Provision for (benefit from) income taxes		991		280		(61,049)		526
Net income	$	8,046	$	11,286	$	96,551	$	19,794

Earnings per share — basic	$	0.23	$	0.33	$	2.74	$	0.58
Weighted-average shares — basic		35,373,909		34,540,126		35,210,966		34,346,071

Earnings per share — diluted	$	0.22	$	0.32	$	2.42	$	0.56
Weighted-average shares — diluted		36,261,174		35,069,188		41,274,190		35,054,777

See accompanying notes to the ~~condensed consolidated financial statements.~~Condensed Consolidated Financial Statements.

Collegium Pharmaceutical, Inc.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

Nine Months Ended September 30,

2017


2016
Operating activities

Net loss
$
(57,462)

$
(66,617)
Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation and amortization

464

360
Lease incentive

(26)

(25)
Stock-based compensation expense

5,867

4,137
Changes in operating assets and liabilities:

     Accounts receivable

(3,694)

(1,679)
     Inventories

(85)

(1,576)
     Prepaid expenses and other assets

(33)

(114)
     Accounts payable

(4,124)

5,401
     Accrued expenses

10,315

4,409
     Deferred revenue

(4,944)

3,938
Net cash used in operating activities

(53,722)

(51,766)
Investing activities

Purchase of intangible assets

—

(2,500)
Purchases of property and equipment

(818)

(136)
Net cash used in investing activities

(818)

(2,636)
Financing activities

Proceeds from issuances of common stock from public offerings, net of issuance costs of $507 and $526

9,425

51,619
Proceeds from issuances of common stock from employee stock purchase plans

1,141

—
Repayment of term note

(2,000)

(2,000)
Proceeds from the exercise of stock options

428

114
Payments made for employee restricted stock tax withholdings

(68)

—
Net cash provided by financing activities

8,926

49,733

Net (decrease) increase in cash and cash equivalents

(45,614)

(4,669)
Cash and cash equivalents at beginning of period

153,225

95,697
Cash and cash equivalents at end of period
$
107,611

$
91,028

Supplemental disclosure of cash flow information

Cash paid for offering costs
$
447

$
512
Cash paid for interest
$
121

$
226

Supplemental disclosure of non-cash activities

Offering costs in accrued expenses
$
60

$
—
Receivable from issuance of common stock from at-the-market offering in other current assets
$
2,090

—
Acquisition of property and equipment in accrued expenses
$
97

$
—


	Nine months ended September 30,
		2021		2020
Operating activities
Net income	$	96,551	$	19,794
Adjustments to reconcile net income to net cash used in operating activities:
Amortization expense		50,386		43,885
Depreciation expense		1,312		589
Deferred income taxes		(63,026)		—
Stock-based compensation expense		19,343		15,700
Non-cash lease expense		20		49
Non-cash interest expense for amortization of debt discount and issuance costs		2,627		6,427
Changes in operating assets and liabilities:
Accounts receivable		(65,679)		(3,513)
Inventory		(2,260)		(9,315)
Prepaid expenses and other assets		1,230		39
Accounts payable		(2,286)		244
Accrued expenses		(6,028)		(15,231)
Accrued rebates, returns and discounts		35,169		12,697
Net cash provided by operating activities		67,359		71,365
Investing activities
Purchase of intangible asset		—		(368,226)
Purchases of property and equipment		(1,429)		(4,065)
Net cash used in investing activities		(1,429)		(372,291)
Financing activities
Proceeds from issuances of common stock from employee stock purchase plans		755		758
Proceeds from the exercise of stock options		9,613		6,394
Payments made for employee stock tax withholdings		(4,149)		(2,169)
Repurchases of common stock		(15,524)		—
Proceeds from issuance of term note, net of issuance costs of $2,456		—		192,117
Proceeds from convertible senior notes, net of issuance costs of $5,473		—		138,277
Repayment of term notes		(37,500)		(25,000)
Repayment of term loan		—		(11,500)
Net cash (used in) provided by financing activities		(46,805)		298,877

Net increase (decrease) in cash, cash equivalents and restricted cash		19,125		(2,049)
Cash, cash equivalents and restricted cash at beginning of period		176,663		170,019
Cash, cash equivalents and restricted cash at end of period	$	195,788	$	167,970

Reconciliation of cash, cash equivalents and restricted cash to the Consolidated Balance Sheets:
Cash and cash equivalents	$	193,241	$	165,423
Restricted cash		2,547		2,547
Total cash, cash equivalents and restricted cash	$	195,788	$	167,970

Supplemental disclosure of cash flow information
Cash paid for interest	$	14,573	$	14,718
Cash paid for income taxes	$	2,329	$	—


Supplemental disclosure of non-cash activities
Acquisition of property and equipment in accounts payable and accrued expenses	$	301	$	738
Accrued royalties discharged upon closing of asset acquisition	$	—	$	1,145
Accrued repurchases of common stock	$	1,956	$	—
Inventory used in the construction and installation of property and equipment	$	516	$	1,812

See accompanying notes to the ~~condensed consolidated financial statements.~~Condensed Consolidated Financial Statements.

Table of Contents

Collegium Pharmaceutical, Inc.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

(unaudited, in thousands, except share and per share amounts)

1. Nature of Business

Collegium Pharmaceutical, Inc. (the “Company”) was incorporated in Delaware in April 2002 and then reincorporated in Virginia in July 2014. The Company has its principal operations in ~~Canton,~~Stoughton, Massachusetts. The Company is a specialty pharmaceutical company ~~developing and commercializing next-generation abuse-deterrent products that incorporate~~committed to being the ~~Company’s patented DETERx® technology platform for the treatment of chronic~~leader in responsible pain ~~and other diseases.~~management. The Company’s first product, Xtampza ~~ER®, or Xtampza,~~^® ER, is an abuse-deterrent, extended-release, oral formulation of ~~oxycodone, a widely prescribed opioid medication.~~oxycodone. In April 2016, the ~~U.S.~~United States Food and Drug Administration ~~(“FDA”~~(the “FDA”) approved the Company’s new drug application (“NDA”) ~~filing~~ for Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. In June 2016, the Company announced the commercial launch of ~~Xtampza.~~Xtampza ER.

The Company’s product portfolio also includes Nucynta^® ER and Nucynta IR (the “Nucynta Products”). On February 6, 2020, the Company entered into an Asset Purchase Agreement with Assertio Therapeutics, Inc. (“Assertio”), pursuant to which the Company agreed to acquire from Assertio certain assets related to the Nucynta Products (the “Nucynta Acquisition”) that it had previously licensed pursuant to a 2017 commercialization agreement with Assertio (the “Nucynta Commercialization Agreement”). The Nucynta Acquisition included a license from Grünenthal GmbH (“Grünenthal”), pursuant to which the Company assumed all commercialization responsibilities, including sales and marketing, for the Nucynta Products. The Nucynta Acquisition was consummated on February 13, 2020 for an aggregate purchase price of $375,000, subject to certain closing and post-closing adjustments as described in the Nucynta Purchase Agreement. Following the closing, the Company’s prior royalty obligation to Assertio ceased and the Company’s only remaining royalty obligation is to pay 14% of net sales of the Nucynta Products directly to Grünenthal.

The Company periodically reviews its accounting estimates in light of changes in circumstances, facts and experience. As of the date of the filing of this Quarterly Report on Form 10-Q, the Company expects the COVID-19 pandemic and actions taken to contain it to continue to impact its revenue. Notwithstanding the lifting of COVID-19 restrictions in many jurisdictions, and amidst continuing public health concerns relating to the spread of COVID-19, weekly pain patient office visits continue to be depressed compared to pre-COVID periods, which in turn may account for fewer patients beginning therapy with the Company’s products. The Company believes that the disruptions caused by COVID-19 will continue and there remains substantial uncertainty as to when such disruptions will cease.

The Company’s operations are subject to certain risks and uncertainties. The principal risks include inability to continue successfully ~~commercialize~~commercializing products, changing market conditions for products and ~~product candidates (including~~ development of competing ~~products),~~products, changing regulatory environment and reimbursement landscape, ~~negative outcome~~litigation related to opioid marketing and distribution practices, inability to manufacture adequate commercial inventory, inability to secure adequate supplies of ~~clinical trials, inability or delay in completing clinical trials or obtaining regulatory approvals, the need to retain key personnel and protect~~active pharmaceutical ingredients, protection of intellectual property, and patent infringement ~~litigation and the availability of additional capital financing on terms acceptable to the Company.~~litigation.

The Company has experienced net losses and negative cash flows from operating activities since its inception, and, as of September 30, 2017 had an accumulated deficit of $280,646. The Company expects to continue to incur net losses in the foreseeable future. A successful transition to profitable operations is dependent upon achieving a level of revenues adequate to support the Company’s cost structure.

The Company believes that its cash and cash equivalents at September 30, ~~2017,~~2021, together with expected cash inflows from the commercialization of ~~Xtampza, as well as proceeds from~~ its ~~ATM offering through October 2017 (see note 2),~~products, will enable the Company to fund its operating expenses, debt service and capital expenditure requirements ~~into mid-2019. The Company may never achieve profitability, and unless and until it does,~~under its current business plan for the Company will continue to need to raise additional cash. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with strategic partners or from other sources. If the Company is unable to obtain financing or increase profitability, the related lack of liquidity will have a material adverse effect on the Company’s operations and future prospects.foreseeable future.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited ~~condensed consolidated financial statements~~Condensed Consolidated Financial Statements include the accounts of Collegium Pharmaceutical, Inc.~~, a~~ (a Virginia ~~corporation,~~corporation) as well as the accounts of Collegium Securities Corp.~~, a~~ (a Massachusetts ~~corporation,~~corporation), incorporated in December 2015, ~~a wholly-owned subsidiary~~and Collegium NF, LLC (a Delaware limited liability company), organized in December 2017, both wholly owned subsidiaries requiring consolidation. The consolidated financial statements of the Company have been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) for interim financial reporting and as required by Regulation S-X, Rule 10-01.

Table of Contents

Accordingly, they do not include all of the information and footnotes required by GAAP for complete consolidated financial statements.

In the opinion of the Company’s management, the accompanying unaudited ~~condensed consolidated financial statements~~Condensed Consolidated Financial Statements contain all adjustments (consisting of items of a normal and recurring nature) necessary to fairly present the financial position of the Company as of September 30, ~~2017,~~2021, and the results of operations ~~for three and nine months ended September 30, 2017 and 2016~~, and cash flows ~~for the nine months ended September 30, 2017 and 2016.~~ ~~The results of operations~~ for the three and nine months ended September 30, ~~2017~~2021 and 2020. The results of operations for the nine months ended September 30, 2021 are not necessarily indicative of the results to be expected for the full year.

~~Table~~The preparation of ~~Contents~~

~~When preparing financial statements~~the Condensed Consolidated Financial Statements in ~~conformity~~accordance with GAAP requires the Company ~~must~~to make estimates and assumptions that impact the reported amounts of assets, liabilities, revenues, costs and expenses and the disclosure of contingent assets and liabilities in the Company’s consolidated financial statements and accompanying notes. ~~The most significant estimates~~Estimates in the Company’s consolidated financial statements ~~relate to~~include revenue recognition, including the estimates of product returns, units prescribed, discounts and allowances related to commercial sales of ~~Xtampza, estimates utilized in the valuation of inventory,~~products, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, impairment of intangible assets and tax valuation ~~reserves and accrued expenses.~~allowances. The Company bases estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions or conditions. The consolidated interim financial statements should be read in conjunction with the audited financial statements and notes thereto included in the Company’s Annual ~~Report.~~Report on Form 10-K for the fiscal year ended December 31, 2020 (the “Annual Report”).

~~Public Offerings of Common Stock~~Subsequent Events

In ~~January 2016,~~November 2021, the ~~Company issued and sold in a public offering~~Company’s Board of Directors authorized an ~~aggregate~~accelerated share repurchase program to repurchase $25,000 of ~~2,750,000 shares of its~~the company’s common stock, at $20.00 per share. The Company received net proceeds from this public offering of approximately $51,174, after deduction of underwriting discounts and commissions and expenses payable by the Company.

In October 2016, the Company issued and sold in a public offering an aggregate of 5,750,000 shares of its common stock at $16.00 per share. The Company received net proceeds from this public offering of approximately $86,166, after deduction of underwriting discounts and commissions and expenses payable by the Company.

~~Controlled Equity Offering Sales Agreement~~

~~In March 2017, the Company entered into a Controlled Equity Offering Sales Agreement (the “ATM Sales Agreement”), with Cantor Fitzgerald & Co.,~~ as ~~sales agent (“Cantor Fitzgerald”), pursuant to which the Company may issue and sell, from time to time, through Cantor Fitzgerald, shares~~part of the ~~Company’s common stock, up to an aggregate offering price of $60,000 (the “ATM Shares”).~~$100,000 Repurchase Program authorized in August 2021.

Under the ATM Sales Agreement, Cantor Fitzgerald may sell the ATM Shares by methods deemed to be an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended (the “Securities Act”), including sales made directly on The NASDAQ Global Select Market, on any other existing trading market for the ATM Shares or to or through a market maker. In addition, under the ATM Sales Agreement, Cantor Fitzgerald may sell the ATM Shares by any other method permitted by law, including in privately negotiated transactions.

The Company is not obligated to make any sales of the ATM Shares under the ATM Sales Agreement. The Company or Cantor Fitzgerald may suspend or terminate the offering of ATM Shares upon notice to the other party and subject to other conditions. The Company will pay Cantor Fitzgerald a commission of up to 3.0% of the gross proceeds from the sale of the ATM Shares pursuant to the ATM Sales Agreement and has agreed to provide Cantor Fitzgerald with customary indemnification and contribution rights.

As of September 30, 2017, the Company had sold an aggregate of 1,148,466 ATM Shares under the ATM Sales Agreement at an average gross sales price of $10.42 per share generating net proceeds of $11,455, after deduction of underwriting discounts and commissions and expenses payable by the Company, all of which were sold during the three months ended September 30, 2017.

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~~Revenue Recognition~~

Revenue for product sales is recognized when there is persuasive evidence of an arrangement, title and risk of loss have passed to the customer, which generally occurs upon delivery, and when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable, and when collectability is reasonably assured. Product sales are recorded net of estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, as well as estimated product returns.

Beginning in the third quarter of 2017, the Company has determined that it has sufficient experience with sales of Xtampza to estimate its returns at time of shipment. The Company sells its products primarily to distributors and retailers (“customers”), which in turn sell the product to pharmacies for the treatment of patients. The Company provides the right of return to its customers for a limited time before and after its expiration date. As a result of its experience to date with Xtampza sales, the Company determined that it can reasonably estimate the amount of future product returns. The effect on income from operations and on net income is that the Company is able to recognize revenue earlier on the sell-in method, net of a provision for estimated returns, because the Company can record revenue once sold to the customer rather than waiting until the product is sold to the end user on a sell-through method. The Company recorded a one-time $4,377 increase to revenues during the three months ended September 30, 2017 as a result of the Company’s change to the sell-in method in the third quarter of 2017.

~~Subsequent Events~~

The Company considers events or transactions that occur after the balance sheet date but before the financial statements are issued to provide additional evidence relative to certain estimates or to identify matters that require additional disclosure. Subsequent events have been evaluated through the date of issuance of these financial statements.

In October 2017, the Company sold an additional 1,793,290 ATM Shares under the ATM Sales Agreement at an average gross sales price of $11.29 per share generating net proceeds of $19,646, after deduction of underwriting discounts and commissions and expenses payable by the Company.

Significant Accounting Policies

The Company’s significant accounting policies are described in Note 2, “Summary of Significant Accounting Policies,” in the Company’s Annual ~~Report on Form 10-K for the fiscal year ended December 31, 2016.~~

~~Advertising and Product Promotion Costs~~

~~Advertising and product promotion costs are included in selling, general and administrative expenses and were $2,489 and $3,486~~Report. There have been no material changes in the ~~three months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs were $8,916 and $10,492~~Company’s significant accounting policies, other than the adoption of accounting pronouncements below, as compared to the significant accounting policies described in the ~~nine months ended September 30, 2017 and 2016 respectively. Advertising and product promotion costs are expensed as incurred.~~Annual Report.

~~Recent~~Recently Adopted Accounting Pronouncements

~~New accounting pronouncements are issued periodically by~~In December 2019, the Financial Accounting Standards Board (“FASB”) ~~and are adopted by the Company as of the specified effective dates.~~

~~In May 2014, the~~ ~~FASB,~~ issued Accounting Standards Update or(“ASU”) 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes. The amendments in ASU~~, 2014-09 (ASC 606),~~ ~~Revenue from Contracts with Customers, which affects any entity that either enters into contracts with customers to transfer goods and services or enters into contracts for the transfer~~ 2019-12 affect a wide variety of ~~nonfinancial assets. In August 2015, the FASB issued ASU 2015-14,~~ ~~Revenue from Contracts with Customers, which defers the effective date of ASU 2014-09 for all entities by one year. ASU 2014-09, which has been codified~~income tax accounting standards with the ~~Accounting Standards Codification as Topic 606, is now~~objective of reducing their complexity. The new standard became effective for ~~public companies for~~ annual ~~reporting~~and interim periods beginning after December 15, ~~2017, including interim periods within those reporting periods. ASC 606 outlines~~2020. The Company adopted this standard effective January 1, 2021 and the adoption did not have a ~~single comprehensive model for entities~~material impact on the Company’s condensed consolidated financial statements.

In March 2020, the FASB issued ASU 2020-04, Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting, to ~~use~~ease the potential burden in accounting for ~~revenue arising from~~reference rate reform. The amendments in ASU 2020-04 are elective and apply to all entities that have contracts, ~~with customers~~hedging relationships, and ~~supersedes most current revenue recognition guidance, including industry-specific guidance. In addition, ASC 606 provides~~other transactions that reference LIBOR or another reference rate expected to be discontinued due to reference rate reform. The new standard became effective immediately and may be applied prospectively to contracts and transactions through December 31, 2022. Subsequent to issuance, the FASB issued ASU 2021-01 in January 2021 to refine and clarify some of its guidance on ~~accounting for certain revenue-related costs including, but not limited~~ASU 2020-04. Upon the transition of the Company’s contracts and transactions to ~~when to capitalize costs associated~~new reference rates in connection with ~~obtaining and fulfilling a contract. ASC 606 provides companies with~~

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~~two implementation methods. Companies can choose to~~reference rate reform, the Company will prospectively apply the standard ~~retrospectively~~and disclose the effect on its condensed consolidated financial statements.

In August 2020, the FASB issued ASU 2020-06, Debt - Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging - Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity. This ASU simplifies the complexity associated with applying U.S. GAAP for certain financial instruments with characteristics of liabilities and equity. More specifically, the amendments focus on the

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guidance for convertible instruments and derivative scope exceptions for contracts in an entity’s own equity. Under ASU 2020-06, the embedded conversion features are no longer separated from the host contract for convertible instruments with conversion features that are not required to ~~each prior reporting period presented (full retrospective application)~~be accounted for as derivatives under Topic 815, or ~~retrospectively with~~that do not result in substantial premiums accounted for as paid-in capital. Consequently, a convertible debt instrument, such as the ~~cumulative effect of initially applying~~Company’s convertible senior notes, will be accounted for as a single liability measured at its amortized cost, as long as no other features require bifurcation and recognition as derivatives. The new guidance also requires the ~~standard as an adjustment~~if-converted method to ~~the opening balance of retained earnings of the annual reporting period that includes the date of initial application (modified retrospective application). Since ASU 2014-09 was issued, several~~be applied for all convertible instruments and requires additional ~~ASUs have been issued~~disclosures. This guidance is required to be adopted by January 1, 2022, and ~~incorporated within ASC 606 to clarify various elements of the guidance.~~ early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020.

The Company ~~will~~elected to early adopt ~~the standard in the first quarter of 2018~~this guidance on January 1, 2021 using the modified retrospective method. ~~The new standard differs from~~Under this transition method, the ~~current accounting standard in many respects, including~~cumulative effect of the accounting ~~for variable consideration. Under~~change was removing the impact of recognizing the equity component of the Company’s ~~current~~convertible notes (at issuance and the subsequent accounting ~~policy, the Company recognizes product revenues and cost~~impact of ~~product revenues at time of delivery to customers.~~additional interest expense from debt discount amortization). The ~~Company is still evaluating its contracts with customers and assessing the potential impacts~~cumulative effect of the ~~new standard on existing arrangements. However,~~accounting change as of January 1, 2021 was an increase to the ~~Company does not expect~~carrying amount of the ~~implementation~~convertible notes of $39,489, a reduction to accumulated deficit of $5,288, and a reduction to additional paid-in capital of $44,777. Interest expense of the convertible senior notes will be lower as a result of adoption of this guidance and diluted net loss per share will ~~have~~be computed using the if-converted method for the convertible senior notes. As a ~~material impact on its consolidated financial statements as~~result of the ~~timing~~adoption of ~~revenue recognition~~this guidance, interest expense was decreased and net income was increased by $1,651, and basic and diluted earnings per share were increased by $0.05 and $0.04, respectively, for ~~product sales is not expected to change significantly.~~the three months ended September 30, 2021. Interest expense was decreased by and net income was increased by $4,804, basic earnings per share was increased by $0.13, and diluted earnings per share was decreased by $0.10 for the nine months ended September 30, 2021.

In ~~February 2016,~~May 2021, the FASB issued ASU ~~2016-02,~~ ~~Leases~~2021-04, Earnings Per Share (Topic ~~842)~~.260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This ASU ~~2016-02 most significantly impacts lessee~~clarifies and reduces diversity in an issuer’s accounting ~~and disclosures. First, this guidance requires lessees to identify arrangements~~for modifications or exchanges of freestanding equity-classified written call options that should be accounted for as leases. Under ASU 2016-02, for lease arrangements exceeding a 12-month term, a right-of-use asset and lease obligation is recorded by the lessee for all leases, whether operatingremain equity classified after modification or ~~financing, while the income statement will reflect lease expense for operating leases and amortization/interest expense for financing leases.~~exchange. The balance sheet amount recorded for existing leases at the date of adoption of ASU 2016-02 must be calculated using the applicable incremental borrowing rate at the date of adoption. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases today. In addition, ASU 2016-02 requires the use of the modified retrospective method, which will require adjustment to all comparative periods presented in the consolidated financial statements. This guidancestandard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, ~~2018. Early adoption is permitted for all entities.~~2021. The Company has not ~~chosen early adoption for~~yet adopted this ASU and ~~is currently evaluating its effect on the Company’s consolidated financial statements.~~

~~In August 2016, the FASB issued ASU 2016-15,~~ ~~Classification of Certain Cash Receipts and Cash Payments, and in November 2016, the FASB issued ASU 2016-18,~~ ~~Restricted Cash~~. The amendments in these updates are effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company will adopt these standards in the first quarter of 2018 using the retrospective transition method as required with respect to each period presented. The Company expects the adoption of these standards will result in an increase in net cash provided by investing activities of $16 for the year ended December 31, 2015. The Company does not expect ~~the~~ adoption ~~of these standards~~ to have a material impact on ~~its~~the Company’s condensed consolidated financial statements.

Recently Issued Accounting Pronouncements Not Yet Adopted

Other recent accounting pronouncements issued, but not yet effective, are not expected to be applicable to the Company or have a material effect on the consolidated financial statements upon future adoption.

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3. Revenue from Contracts with Customers

The Company’s revenue to date is from sales of the Company’s products, which are primarily sold to distributors (“customers”), which in turn sell the product to pharmacies for the ~~years ended December 31, 2016~~treatment of patients (“end users”).

Revenue Recognition

In accordance with Accounting Standards Codification Topic 606, Revenue from Contracts with Customers (“ASC Topic 606”), the Company recognizes revenue when a customer obtains control of promised goods or ~~December 31, 2017.~~services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC Topic 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only applies the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC Topic 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.

Performance Obligations

The Company determined that performance obligations are satisfied and revenue is recognized when a customer takes control of the Company’s product, which occurs at a point in time. This generally occurs upon delivery of the products to customers, at which point the Company recognizes revenue and records accounts receivable. Payment is typically received 30 to 90 days after satisfaction of the Company’s performance obligations. The Company expenses incremental costs of obtaining a contract as and when incurred if the expected amortization period of the assets is one year or less.

Transaction Price and Variable Consideration

Revenue is measured as the amount of consideration the Company expects to receive in exchange for transferring products or services to a customer (“transaction price”). The transaction price for product sales includes variable consideration related to sales deductions, including (1) rebates and incentives, including managed care rebates, government rebates, co-pay program incentives, and sales incentives and allowances; (2) product returns, including return estimates for both Xtampza ER and the Nucynta Products; and (3) trade allowances and chargebacks, including fees for distribution service fees, prompt pay discounts, and chargebacks. The Company will estimate the amount of variable consideration that should be included in the transaction price under the expected value method for all sales deductions other than trade allowances, which are estimated under the most likely amount method. These provisions reflect the expected amount of consideration to which the Company is entitled based on the terms of the contract. In addition, the Company made a policy election to exclude from the measurement of the transaction price all taxes that are assessed by a governmental authority that are imposed on revenue-producing transactions.

Provisions for rebates and incentives are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period. As the Company’s rebates and incentives are based on products dispensed to patients, the Company is required to estimate the expected value of claims at the time of product delivery to distributors. Given that distributors sell the product to pharmacies, which in turn dispense the product to patients, claims can be submitted significantly later than the related sales are recognized. The Company’s estimates of these claims are based on the historical experience of existing or similar programs, including current contractual and statutory requirements, specific known market events and trends, industry data, and estimated distribution channel inventory levels. Accruals and related reserves required for rebates and incentives are adjusted as new information becomes available, including actual claims. If actual results vary, the Company may need to adjust these estimates, which could have an effect on earnings in the period of the adjustment.

Provisions for product returns are based on product-level historical trends, as well as relevant market events and other factors, including the proper return of the product within the Company’s return policy. The Company’s return policy requires that product is physically returned within an 18-month window beginning six months prior to expiration and up

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~~3. Loss~~

until twelve months after expiration. For Xtampza ER, because the product has only been commercially sold since June 2016, estimates of product returns are based on a combination of historical returns processed to date—taking into consideration the expiration date of the product upon delivery to customers—as well as forecasted customer buying patterns, shipment and prescription trends, channel inventory levels, and other specifically known market events and trends. For the Nucynta Products, estimates of product returns consider historical trends, as the Nucynta Products have been commercially sold for a number of years, as well as actual returns received or credited.

Provisions for trade allowances and chargebacks are primarily based on customer-level contractual terms. Accruals and related reserves are adjusted as new information becomes available, which generally consists of actual trade allowances and chargebacks processed relating to sales recognized in the period.

The amount of variable consideration that is included in the transaction price may be constrained and is included in net sales only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.

The following tables summarize activity in each of the Company’s product revenue provision and allowance categories for the nine months ended September 30, 2021 and 2020:


					Trade
	Rebates and		Product		Allowances and
Nine months ended September 30, 2021	Incentives (1)		Returns (2)		Chargebacks (3)
Balance at December 31, 2020	$	132,775	$	23,779	$	19,055
Provision related to current period sales		273,576		13,750		63,279
Changes in estimate related to prior period sales		(434)		—		6
Credits/payments made		(261,210)		(3,473)		(58,213)
Credits expired (4)		—		12,960		—
Balance at September 30, 2021	$	144,707	$	47,016	$	24,127


					Trade
	Rebates and		Product		Allowances and
Nine months ended September 30, 2020	Incentives (1)		Returns (2)		Chargebacks (3)
Balance at December 31, 2019	$	129,901	$	27,648	$	14,020
Provision related to current period sales		242,389		9,218		55,967
Changes in estimate related to prior period sales		(122)		—		(182)
Credits/payments made		(237,044)		(1,744)		(56,985)
Balance at September 30, 2020	$	135,124	$	35,122	$	12,820

(1)

Provisions for rebates and incentives includes managed care rebates, government rebates and co-pay program incentives. Provisions for rebates and incentives are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Condensed Consolidated Balance Sheets.

(2)

Provisions for product returns are deducted from gross revenues at the time revenues are recognized and are included in accrued rebates, returns and discounts in the Company’s Condensed Consolidated Balance Sheets.

(3)

Provisions for trade allowances and chargebacks include fees for distribution service fees, prompt pay discounts, and chargebacks. Trade allowances and chargebacks are deducted from gross revenue at the time revenues are recognized and are recorded as a reduction to accounts receivable in the Company’s Condensed Consolidated Balance Sheets.

(4)

During the nine months ended September 30, 2021, $12,960 of previously credited product returns were no longer eligible for credit under the Company’s returns policy as the product was not received as of the period end.

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As of September 30, 2021, the Company did not have any transaction price allocated to remaining performance obligations and any costs to obtain contracts with customers, including pre-contract costs and set up costs, were immaterial.

Disaggregation of Revenue

The Company discloses disaggregated revenue from contracts with customers into categories that depict how the nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factors. When selecting the type of category to use to disaggregate revenue, the Company considers how information about the Company’s revenue has been presented for other purposes as well as what information is regularly reviewed and used for evaluating financial performance. As such, the Company disaggregates its product revenue, net from contracts with customers by product, as disclosed in the table below.


	Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020
Xtampza ER	$	30,016	$	32,126	$	98,448		97,191
Nucynta Products⁽¹⁾		48,827		47,050		151,058		136,554
Total product revenues, net	$	78,843	$	79,176	$	249,506	$	233,745

(1) For the three months ended September 30, 2021, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $29,086 and $19,741, respectively. For the three months ended September 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $30,000 and $17,050, respectively. For the nine months ended September 30, 2021, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $88,853 and $62,205, respectively. For the nine months ended September 30, 2020, the Company recognized Nucynta IR and Nucynta ER product revenues, net of $87,044 and $49,510, respectively.

4. License Agreements

The Company periodically enters into license agreements to develop and commercialize its products. As of December 31, 2019, the Company’s only license agreement was the Nucynta Commercialization Agreement. Upon the closing of the Nucynta Acquisition in February 2020, the Nucynta Commercialization Agreement was effectively terminated. Prior to the Nucynta Acquisition, the Company was conditionally obligated to make royalty payments to Assertio conditional upon net sales.

Upon the closing of the Nucynta Acquisition, the Nucynta Commercialization Agreement was effectively terminated and the Company’s royalty payment obligations to Assertio thereunder ceased. Following the closing, the Company no longer pays royalties to Assertio and the Company’s only remaining royalty obligation is to pay 14% of net sales of the Nucynta Products directly to Grünenthal.

The assets acquired, liabilities assumed, and equity interests issued by the Company in connection with the Nucynta Commercialization Agreement are further described in Note 8.

5. Earnings Per Share

Basic earnings per ~~Common Share~~share is calculated by dividing net income by the weighted average number of shares of common stock outstanding during the period. Diluted earnings per share is computed by dividing net income by the weighted average number of shares of common stock, plus potentially dilutive securities outstanding for the period, as determined in accordance with the treasury stock or if-converted accounting method. Potentially dilutive securities outstanding

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include stock options, unvested restricted stock units (“RSUs”), performance share units (“PSUs”), warrants, and shares related to the convertible senior notes, but are only included to the extent that their addition is dilutive.

The following table presents the computations of basic and dilutive ~~net loss~~earnings per common share:

Three months ended September 30,

Nine months ended September 30,

2017

2016

2017

2016

Loss attributable to common shareholders — basic and diluted
$
(13,263)

$
(26,444)

$
(57,462)

$
(66,617)

Weighted-average number of common shares used in net loss per share - basic and diluted

29,753,043

23,460,340

29,517,396

23,334,558

Loss per share - basic and diluted
$
(0.45)

$
(1.13)

$
(1.95)

$
(2.85)


	Three months ended September 30,				Nine months ended September 30,
		2021		2020		2021		2020
Numerator:
Net income	$	8,046	$	11,286	$	96,551	$	19,794
Adjustment for interest expense recognized on convertible senior notes:		—		—		3,504		—
Net income — diluted	$	8,046	$	11,286	$	100,055	$	19,794
Denominator:
Weighted-average shares outstanding — basic		35,373,909		34,540,126		35,210,966		34,346,071
Effect of dilutive securities:
Stock options		435,099		325,569		564,171		438,112
Restricted stock units		333,572		194,127		405,632		250,663
Performance share units		—		9,366		—		8,736
Employee stock purchase plan		1,829		—		3,403		—
Warrants		116,765		—		164,884		11,195
Convertible senior notes		—		—		4,925,134		—

Weighted average shares outstanding — diluted		36,261,174		35,069,188		41,274,190		35,054,777

Earnings per share — basic	$	0.23	$	0.33	$	2.74	$	0.58
Earnings per share — diluted	$	0.22	$	0.32	$	2.42	$	0.56

~~Table~~The Company has the option to settle the conversion obligation for its convertible senior notes due in 2026 in cash, shares or a combination of ~~Contents~~the two. Since the Company intends to settle the principal amount of the convertible senior notes in cash, the Company used the treasury stock method for determining the potential dilution in the diluted earnings per share computation for the three and nine months ended September 30, 2020. Effective for the three and nine months ended September 30, 2021, the Company used the if-converted method for the convertible senior notes as a result of the adoption of ASU 2020-06, as described in Recently Adopted Accounting Pronouncements above.

The following ~~potentially~~table presents dilutive securities ~~which represent all outstanding potentially dilutive~~excluded from the calculation of diluted earnings per share:


	Three months ended September 30,		Nine months ended September 30,
	2021	2020	2021	2020
Stock options	1,433,791	2,418,599	1,360,024	2,305,756
Restricted stock units	694,694	601,679	50,450	601,679
Performance share units	353,100	267,498	353,100	267,498
Employee stock purchase plan	—	26,137	—	26,137
Warrants	—	1,041,667	—	—
Convertible senior notes	4,925,134	4,925,134	—	4,925,134

For PSUs, these securities were excluded from the calculation of diluted ~~net loss~~earnings per share ~~due to~~as the performance-based or market-based vesting conditions were not met as of the end of the reporting period. For all other securities, these securities were excluded from the calculation of diluted earnings per share as their inclusion would have had an anti-dilutive ~~effect (in common stock equivalent shares):~~

Three months ended September 30,

Nine months ended September 30,

2017

2016

2017

2016

Outstanding stock options
3,056,954

2,258,775

3,056,954

2,258,775

Warrants
2,445

2,445

2,445

2,445

Unvested restricted stock(1)
44,586

95,159

44,586

95,159

Restricted stock units
218,872

41,739

218,872

41,739

(1) - Includes shares of unvested restricted stock remaining from the early exercise of stock options.

effect.

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6. Fair Value of Financial Instruments

Disclosures of fair value information about financial instruments are required, whether or not recognized in the balance sheet, for financial instruments with respect to which it is practicable to estimate that value. Fair value measurements and disclosures describe the fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last unobservable, that may be used to measure fair value, as follows:


Level 1 inputs:	Quoted prices (unadjusted) in ~~(unadjusted)~~ active markets for identical assets or liabilities
Level 2 inputs:	Inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly
Level 3 inputs:	Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability

Transfers are calculated on values as of the transfer date. There were 0 transfers between Levels 1, 2 and 3 during the nine months ended September 30, 2021 and 2020.

The following tables present the Company’s financial instruments carried at fair value using the lowest level input applicable to each financial instrument at September 30, ~~2017~~2021 and December 31, ~~2016.~~2020:

Significant

Quoted Prices

other

Significant

in active

observable

unobservable

markets

inputs

inputs

Description


Total


(Level 1)


(Level 2)


(Level 3)

September 30, 2017

Money market funds, included in cash equivalents

$
81,026

$
81,026

$
—

$
—

December 31, 2016

Money market funds, included in cash equivalents

$
125,515

$
125,515

$
—

$
—


						Significant
				Quoted Prices		other		Significant
				in active		observable		unobservable
				markets		inputs		inputs
		Total		(Level 1)		(Level 2)		(Level 3)
September 30, 2021
Money market funds, included in cash equivalents	$	45,076	$	45,076	$	—	$	—

December 31, 2020
Money market funds, included in cash equivalents	$	45,069	$	45,069	$	—	$	—

~~The Company’s cash equivalents are comprised of money market funds that are measured on a recurring basis based on quoted market prices.~~ As of September 30, ~~2017~~2021, the convertible senior notes had a fair value of approximately $144,759 and a net carrying value of $139,738. The fair value of the Company’s convertible senior notes fall into the Level 2 category within the fair value level hierarchy. The fair value was determined using broker quotes in a non-active market for valuation.

The fair value of the Company’s term notes fall into the Level 2 category within the fair value level hierarchy and the fair value was determined using quoted prices for similar liabilities in active markets, as well as inputs that are observable for the liability (other than quoted prices), such as interest rates that are observable at commonly quoted intervals.

As of September 30, 2021, and December 31, ~~2016~~2020, the carrying amounts of the cash and cash equivalents, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses, ~~deferred revenue~~accrued rebates, returns and ~~loan~~discounts, and term notes payable reasonably approximated their estimated fair ~~values because~~values.

7. Inventory

Inventory as of ~~the short-term nature of these financial instruments.~~

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~~5. Inventory~~

~~Inventory~~September 30, 2021 and December 31, 2020 consisted of the following:


	As of September 30,		As of December 31,
	2017		2016

					As of September 30,		As of December 31,
					2021		2020
Raw materials	$	599	$	294	$	4,216	$	3,514
Work in process		168		67		2,443		1,096
Finished goods		634		955		10,699		11,004
Total inventory	$	1,401	$	1,316	$	17,358	$	15,614

The aggregate charges related to excess inventory for ~~both~~ the three and nine months ended September 30, ~~2017~~2021 and ~~2016~~ 2020

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were immaterial. These expenses were recorded as a component of cost of product revenues. During the three and nine months ended September 30, 2021, inventory used in the construction and installation of property and equipment was 0 and $516, respectively. During the three and nine months ended September 30, 2020, inventory used in the construction and installation of property and equipment was $1,199 and $1,812, respectively.

6.8. Intangible Asset

As of September 30, 2021 and December 31, 2020, the Company’s only intangible asset (the “Nucynta Intangible Asset”) is related to the Nucynta Acquisition and Nucynta Commercialization Agreement. The gross carrying amount and accumulated amortization of the Nucynta Intangible Asset were as follows:


	As of September 30,		As of December 31,
	2021		2020
Gross carrying amount	$	521,170	$	521,170
Accumulated amortization		(235,652)		(185,266)
Intangible asset, net	$	285,518	$	335,904

Nucynta Acquisition

In ~~May 2016,~~February 2020, the Company entered into the Nucynta Purchase Agreement with Assertio, pursuant to which the Company acquired certain intellectual property and manufacturing rights related to the Nucynta Products, including U.S. commercialization rights, U.S. manufacturing rights, and inventory, for an aggregate purchase price of $375,000, subject to certain closing and post-closing adjustments. The Company also agreed to assume certain regulatory and supply chain contracts, and obligations related to Nucynta Products (see Note 4). In February 2020, the Company entered into a loan agreement ~~with BioDelivery Sciences International, Inc. (“BDSI”)~~(see Note 10) and issued convertible senior notes (see Note 11) to ~~license~~finance a portion of the ~~rights~~purchase price paid pursuant to ~~develop, manufacture, and commercialize Onsolis® (fentanyl buccal soluble film), or Onsolis,~~the Nucynta Purchase Agreement.

The consideration transferred in the United States. Onsolis is a Transmucosal Immediate-Release Fentanyl (“TIRF”) film indicated for the management of breakthrough pain in certain cancer patients. The Company expects to launch the product after the completion of the transfer of manufacturing and required submission to the FDA of a Prior Approval Supplement. ~~Subject to FDA approval of the Prior Approval Supplement, the Company expects to launch~~ ~~Onsolis in~~ ~~mid-2018. In addition, during the term of the License Agreement, milestone payments in the aggregate amount of $21,000 may become payable~~asset acquisition was measured at cost, including transaction costs, assets transferred by the Company, ~~subject~~and royalty obligations discharged by the seller. The table below represents the costs accumulated to acquire the commercial rights for the Nucynta Products based on the terms of the Nucynta Purchase Agreement, as amended:


Acquisition consideration:
Base purchase price	$	375,000
Cash paid for inventory		6,030
Transaction costs		6,297
Reduction for 2020 cash transferred to Assertio under the prior Nucynta Commercialization Agreement₍₁₎		(13,071)
Reduction for accrued royalty obligation discharged upon closing₍₁₎		(1,145)
Total acquisition consideration:	$	373,111

(1)

Represents $14,216 total reduction to the base purchase price comprising of $13,071 of cash payments transferred to Assertio under the prior Nucynta Commercialization Agreement as well as a reduction for discharged pre-acquisition accrued royalties based on sales from January 1, 2020 through closing.

The Company then allocated the consideration transferred to the ~~satisfaction of certain commercialization,~~individual assets acquired on a relative fair value basis as summarized in the table below:


Assets acquired:
Nucynta Intangible Asset	$	367,081
Inventory		6,030
Total consideration allocated to assets acquired:	$	373,111

The Company concluded that the consideration allocable to the Nucynta Intangible Asset for the additional intellectual property and ~~net sales milestones, including $4,000~~manufacturing rights it acquired as part of the Nucynta Acquisition were incremental costs associated with

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the pre-existing intangible asset from the former Nucynta Commercialization Agreement, as such costs result in probable future economic benefits. Specifically, the additional intellectual property rights acquired in the Nucynta Acquisition enable the Company to eliminate royalty obligations otherwise payable to Assertio under the former Nucynta Commercialization Agreement.

Effective February 13, 2020, upon the ~~first commercial sale~~closing of the ~~product in~~Nucynta Acquisition, the ~~U.S. Finally,~~Nucynta Commercialization Agreement was effectively terminated and the Company’s royalty payment obligations to Assertio thereunder ceased. Following the closing, the Company ~~will be required~~no longer pay royalties to Assertio and the Company’s only remaining royalty obligation is to pay ~~royalties in the upper teens based on annual~~14% of net sales of the Nucynta Products directly to Grünenthal.

A summary of the gross carrying amount, accumulated amortization, and net book value of the Nucynta Intangible Asset is as follows:


		Gross Carrying Value		Accumulated Amortization		Net Book Value
Balance as of December 31, 2019	$	154,089	$	(124,586)	$	29,503
Amortization expense through Nucynta Acquisition		—		(1,754)		(1,754)
Additional cost incurred from Nucynta Acquisition		367,081		—		367,081
Amortization expense from Nucynta Acquisition through period end		—		(58,926)		(58,926)
Balance as of December 31, 2020	$	521,170	$	(185,266)	$	335,904
Amortization expense through period end		—		(50,386)		(50,386)
Balance as of September 30, 2021	$	521,170	$	(235,652)	$	285,518

Amortization

The Company has been amortizing the Nucynta Intangible Asset over its useful life, which is the period over which the asset is expected to contribute directly or indirectly to the future cash flows of the Company. The Company had initially determined that the useful life for the intangible asset was approximately 4.0 years from the closing date of the Nucynta Commercialization Agreement, January 9, 2018 on the basis of the majority of the cash flows expected to be realized for future product insales under the ~~U.S.~~ AsNucynta Commercialization Agreement. The Nucynta Acquisition significantly impacted the timing and amount of ~~September 30, 2017,~~future cash inflows from the sales of the Nucynta Products, and, therefore, the Company ~~has not satisfied~~considered it to be a triggering event to remeasure the ~~criteria for triggering payment~~expected useful life of ~~milestones or royalties under~~ the ~~License Agreement and has not recognized any liabilities for such milestones or royalties in its consolidated financial statements.~~

Nucynta Intangible Asset. The Company ~~made an upfront payment~~determined that the useful life for the Nucynta Intangible Asset was approximately 5.9 years from the Closing Date of ~~$2,500~~the Nucynta Acquisition and accordingly, the intangible asset is ~~contractually committed to reimburse BDSI up to a maximum of $2,000 for~~amortized prospectively over its ~~out-of-pocket expenses incurred in connection with the manufacturing transfer.~~revised useful life. The Company ~~recorded the upfront payment~~recognizes amortization expense as ~~an intangible asset on~~a component of cost of product revenues in the Condensed Consolidated ~~Balance Sheet and will amortize it~~Statement of Operations on a straight-line basis over ~~the remaining patent life. As of September 30, 2017, the Company has reimbursed BDSI approximately $1,391 for~~ its ~~out-of-pocket expenses incurred in connection with~~useful life as it approximates the ~~manufacturing transfer.~~

~~As a result of U.S. Patent No. 9,597,288 being issued in March 2017, the patent protection for Onsolis was extended through July 2027, a~~ period of ~~approximately 11.2 years~~economic benefits expected to be realized from future cash inflows from sales of the ~~date of original acquisition. As such, the Company revised the useful life of its intangible asset during~~ Nucynta Products.

The following table presents amortization expense recognized for the three ~~months ended March 31, 2017 from 3.7 years to 11.2 years.~~

~~During the three months ended September 30, 2017, the Company recognized amortization expense of $48 compared to $227 for the three months ended September 30, 2016. For the~~and nine months ended September 30, ~~2017 the Company recognized amortization expense~~2021 and 2020:


	Three months ended September 30,				Nine months ended September 30,
		2021		2020		2021		2020
Nucynta amortization expense included in cost of product revenues	$	16,796	$	16,795	$	50,386	$	43,885

Table of ~~$225 compared to $227 for the nine months ended September 30, 2016.~~ Contents

As of September 30, ~~2017,~~2021, the remaining amortization period is approximately ~~9.8~~4.3 years and ~~estimated remaining amortization for 2017, 2018, 2019, 2020, 2021 and thereafter~~ is expected to be ~~$47, $191, $191 $191, $191 and $1,066, respectively.~~ recognized in the following periods:


Years ended December 31,	Amortization Expense
2021	$	16,795
2022		67,181
2023		67,181
2024		67,181
2025		67,180
Remaining amortization expense:	$	285,518

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7.9. Accrued Expenses

Accrued expenses as of September 30, 2021 and December 31, 2020 consisted of the following:

As of September 30,

As of December 31,

2017

2016

Accrued rebates, returns and discounts
$
10,345

$
—

Accrued bonuses

2,089

2,210

Accrued payroll and related benefits

1,762

1,217

Accrued incentive compensation

1,671

1,160

Accrued development costs

1,120

2,485

Accrued sales and marketing

1,076

801

Accrued other operating costs

792

572

Accrued audit and legal

404

416

Accrued interest

9

18

Total accrued expenses
$
19,268

$
8,879


	As of September 30,		As of December 31,
	2021		2020
Accrued royalties	$	6,836	$	12,954
Accrued bonuses		2,924		4,571
Accrued product taxes and fees		2,395		1,817
Accrued repurchases of common stock		1,956		—
Accrued audit and legal		1,657		445
Accrued payroll and related benefits		1,352		892
Accrued incentive compensation		1,279		1,417
Accrued sales and marketing		640		261
Accrued interest		472		1,415
Accrued income taxes		36		—
Accrued other operating costs		1,045		884
Total accrued expenses	$	20,592	$	24,656

10. Term Notes Payable

Pharmakon Term Notes

On February 6, 2020, in connection with the execution of the Nucynta Purchase Agreement, the Company, together with its subsidiary, Collegium Securities Corporation, entered into a Loan Agreement (the “Loan Agreement”) with BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (collectively “Pharmakon”). The Loan Agreement provides for a $200,000 secured term loan (the “term notes”), the proceeds of which were used to finance a portion of the purchase price paid pursuant to the Nucynta Purchase Agreement. On February 13, 2020 (the “Closing Date”), the Company received the $200,000 proceeds from the term notes.

The term notes bear interest at a rate based upon the three-month LIBOR rate, subject to a LIBOR floor of 2.0%, plus a margin of 7.5% per annum, payable quarterly in arrears. The Company is required to repay the term notes by making equal quarterly payments of principal beginning in the first quarter immediately following the third month anniversary of the Closing Date. The term notes will mature on the calendar quarter end immediately following the 48-month anniversary of the Closing Date and are guaranteed by the Company’s material domestic subsidiaries and also secured by substantially all of the Company’s material assets. On the Closing Date, the Company paid to Pharmakon a facility fee equal to 2.50% of the aggregate principal amount of the term notes, or $5,000, in addition to $427 of other expenses incurred by Pharmakon and reimbursed by the Company (together, the “discount”). Net proceeds of $194,573 were transferred to Assertio by the Company as agent in partial satisfaction of the Nucynta Purchase Agreement. In addition, the Company capitalized $2,456 of term notes issuance costs, related to legal and advisory fees.

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Except with respect to certain prepayments made with the proceeds from new equity issuances as described below, the Loan Agreement permits voluntary prepayment at any time, subject to a prepayment premium. The prepayment premium is equal to 3.00% of the principal amount being prepaid prior to the second-year anniversary of the Closing Date, 2.00% of the principal amount being prepaid on or after the second-year anniversary, but on or prior to the third-year anniversary, of the Closing Date, and 1.00% of the principal amount being prepaid on or after the third-year anniversary of the Closing Date, but prior to the fourth-year anniversary of the Closing Date. The Loan Agreement also includes a make-whole premium if there is a voluntary prepayment, a prepayment due to a change in control or acceleration following an Event of Default (as defined in the Loan Agreement) on or prior to the second-year anniversary of the Closing Date, in each case in an amount equal to foregone interest from the date of prepayment through the second-year anniversary of the Closing Date. A change of control triggers a mandatory prepayment of the term notes.

The Loan Agreement also permits single voluntary prepayments of the Loan Agreement of less than or equal to $50,000 made solely from the proceeds of an equity issuance by the Company. If equity prepayment occurs prior to the second-year anniversary of the Closing Date, a prepayment premium of 5.00% would apply, with no make-whole premium.

The Loan Agreement contains certain covenants and obligations of the parties, including, without limitation, covenants that require the Company to maintain $200,000 in annual net sales and covenants that limit the Company’s ability to incur additional indebtedness or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business, restrictions which limit the Company’s ability to pay dividends and restrictions of net assets of subsidiaries. The Loan Agreement also contains customary events of default, including payment defaults, breaches of covenants, change of control and a material adverse change default. Failure to comply with these covenants would constitute an event of default under the Loan Agreement, notwithstanding the Company’s ability to meet its debt service obligations. The Loan Agreement also includes various customary remedies for Pharmakon following an event of default, including the acceleration of repayment of outstanding amounts under the Loan Agreement and execution upon the collateral securing obligations under the Loan Agreement. Under certain circumstances, a default interest rate will apply on outstanding obligations during the occurrence and continuance of an event of default.

During the three and nine months ended September 30, 2021, the Company recognized interest expense of $3,944 and $12,753, respectively, related to the term notes.

As of September 30, 2021, principal repayments under the term notes are estimated to be paid as follows:


Years ended December 31,	Principal Payments
2021	$	12,500
2022		50,000
2023		50,000
2024		12,500
Total before unamortized discount and issuance costs	$	125,000
Less: unamortized discount and issuance costs		(3,033)
Total term notes	$	121,967

Silicon Valley Bank Term Loan Facility

From August 2012 until January 2020, the Company maintained a term loan facility with Silicon Valley Bank (“SVB”), which was amended in connection with, and as a condition to, consummation of the transactions contemplated by the Nucynta Commercialization Agreement. Under the amended term loan (“Consent and Amendment”), the Company had a term loan facility in an amount of $11,500, which replaced the Company’s previously existing term loan facility. The proceeds of the Consent and Amendment were used to finance certain payment obligations under the Nucynta Commercialization Agreement and to repay the balance of the previously existing term loan.

The Consent and Amendment bore interest at a rate per annum of 0.75% above the prime rate (as defined in the Consent and Amendment). The Company was eligible to repay the Consent and Amendment in equal consecutive monthly installments of principal plus monthly payments of accrued interest, commencing in January 2020.

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In January 2020, the Company prepaid the outstanding principal and accrued interest on the Consent and Amendment along with the required prepayment fees. The loss on extinguishment of the term loan was immaterial and was recorded as a component of interest expense.

11. Convertible Senior Notes

On February 13, 2020, the Company issued 2.625% convertible senior notes due in 2026 (the “convertible notes”) in the aggregate principal amount of $143,750, in a public offering registered under the Securities Act of 1933, as amended. The convertible notes were issued in connection with funding the Nucynta Acquisition, and the proceeds of the convertible notes were used to finance a portion of the purchase price payable pursuant to the Nucynta Purchase Agreement. Some of the Company’s existing investors participated in the convertible notes offering.

The Company may, at its option, settle the convertible notes in cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock. Upon issuance the Company separately accounted for the liability component (the “Liability Component”) and the embedded derivative conversion option (the “Equity Component”) of the convertible notes by allocating the proceeds between the Liability Component and the Equity Component. In connection with the issuance of the convertible notes, the Company incurred approximately $5,473 of debt issuance costs, which primarily consisted of underwriting, legal and other professional fees, and allocated these costs between the Liability Component and the Equity Component based on the allocation of the proceeds. Of the total debt issuance costs, $1,773 was allocated to the Equity Component and recorded as a reduction to additional paid-in capital and $3,700 was allocated to the Liability Component and recorded as a debt discount of the convertible notes. The portion allocated to the Liability Component is amortized to interest expense using the effective interest method over six years.

Prior to the adoption of ASU 2020-06 on January 1, 2021, the initial carrying amount of the Liability Component of $97,200 was calculated by measuring the fair value of a similar liability that does not have an associated convertible feature. The allocation was performed in a manner that reflected the Company’s non-convertible borrowing rate for similar debt. The Equity Component of the convertible notes of $46,550 was recognized as a debt discount. The excess of the principal amount of the Liability Component over its carrying amount was amortized to interest expense using the effective interest method over six years.

Subsequent to the adoption of ASU 2020-06 on January 1, 2021, which the Company elected to adopt using the modified retrospective method, the Company removed the impact of recognizing the Equity Component of the senior convertible notes (at issuance and the subsequent accounting impact of additional interest expense from debt discount amortization). The cumulative effective of the accounting change as of January 1, 2021 was an increase to the carrying amount of the convertible notes of $39,489, a reduction to accumulated deficit of $5,288, and a reduction to additional paid-in capital of $44,777.

The convertible notes are the Company’s senior unsecured obligations and bear interest at a rate of 2.625% per year payable semi-annually in arrears on February 15 and August 15 of each year, beginning on August 15, 2020. Before August 15, 2025, noteholders will have the right to convert their notes only upon the occurrence of certain events. From and after August 15, 2025, noteholders may convert their notes at any time at their election until the close of business on the scheduled trading day immediately before the maturity date. The Company will settle conversions by paying or delivering, as applicable, cash, shares of the Company’s common stock or a combination of cash and shares of the Company’s common stock, at the Company’s election. The notes will mature on February 15, 2026, unless earlier repurchased, redeemed or converted. The initial conversion rate is 34.2618 shares of common stock per $1 principal amount of notes, which represents an initial conversion price of approximately $29.19 per share of common stock. The conversion rate and conversion price are subject to adjustment upon the occurrence of certain events.

Holders of the convertible notes may convert all or any portion of their convertible notes, in multiples of $1 principal amount, at their option only under the following circumstances:

(1)

during any calendar quarter commencing after the calendar quarter ending on March 31, 2020, if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price for at least 20 trading days during the 30 consecutive trading days ending on, and including, the last trading day of the immediately preceding calendar quarter;

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(2)

during the 5 consecutive business days immediately after any 10 consecutive trading day period (such 10 consecutive trading day period, the “measurement period”) in which the “trading price” per $1 principal amount of the Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price per share of the Company’s common stock on such trading day and the conversion rate on such trading day;

(3)

upon the occurrence of certain corporate events or distributions on the Company’s common stock;

(4)

if the Company calls the convertible notes for redemption; or

(5)

at any time from, and including, August 15, 2025 until the close of business on the scheduled trading day immediately before the maturity date.

As of September 30, 2021, none of the above circumstances had occurred and as such, the convertible notes could not have been converted.

The Company may not redeem the convertible notes prior to February 15, 2023. On or after February 15, 2023, the Company may redeem the convertible notes, in whole and not in part, at a cash redemption price equal to the principal amount of the Notes to be redeemed, plus accrued and unpaid interest, if any, only if the last reported sale price per share of the Company’s common stock exceeds 130% of the conversion price on:

(1)

each of at least 20 trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and including, the trading day immediately before the date the Company sends the related redemption notice; and

(2)

the trading day immediately before the date the Company sends such notice.

Calling any convertible note for redemption will constitute a make-whole fundamental change with respect to that convertible note, in which case the conversion rate applicable to the conversion of that convertible note, if it is converted in connection with the redemption, will be increased in certain circumstances for a specified period of time.

The convertible notes have customary default provisions, including (i) a default in the payment when due (whether at maturity, upon redemption or repurchase upon fundamental change or otherwise) of the principal of, or the redemption price or fundamental change repurchase price for, any note; (ii) a default for 30 days in the payment when due of interest on any note; (iii) a default in the Company’s obligation to convert a note in accordance with the indenture; (iv) a default with respect to the Company’s obligations under the indenture related to consolidations, mergers and asset sales; (v) certain payment or other defaults by the Company or certain subsidiaries with respect to mortgages, agreements or other instruments for indebtedness for money borrowed of at least $20,000; and (vi) certain events of bankruptcy, insolvency and reorganization with respect to the Company or any of its significant subsidiaries.

As of September 30, 2021, the convertible notes outstanding consisted of the following:


Principal	$	143,750
Less: unamortized issuance costs		(4,012)
Net carrying amount	$	139,738

The Company determined the expected life of the convertible notes was equal to its six-year term. Subsequent to the adoption of ASU 2020-06, the effective interest rate on the convertible notes was 3.26%. As of September 30, 2021, the if-converted value did not exceed the remaining principal amount of the convertible notes.

The following table presents the total interest expense recognized related to the convertible notes during the three and nine months ended September 30, 2021:


	Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020
Contractual interest expense	$	943	$	943	$	2,831	$	2,379
Amortization of debt discount		—		1,620		—		3,979
Amortization of debt issuance costs		228		129		673		316
Total interest expense	$	1,171	$	2,692	$	3,504	$	6,674

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As of September 30, 2021, the future minimum payments on the convertible notes were as follows:


Years ended December 31,	Future Minimum Payments
2021	$	—
2022		3,773
2023		3,773
2024		3,773
2025		3,773
Thereafter		145,638
Total minimum payments	$	160,730
Less: interest		(16,980)
Less: unamortized issuance costs		(4,012)
Convertible senior notes	$	139,738

12. Equity

The changes in shareholders’ equity for the three and nine months ended September 30, ~~2017~~2021 were as follows:


				Additional							Total
	Common Stock			Paid- In		Treasury Stock			Accumulated		Shareholders’
	Shares		Amount	Capital		Shares		Amount	Deficit		Equity
Balance, December 31, 2020	34,612,054	$	35	$	519,143	—	$	—	$	(333,147)	$	186,031
Cumulative effect adjustment for adoption of ASU 2020-06	—		—		(44,777)	—		—		5,288		(39,489)
Exercise of common stock options	289,164		—		4,102	—		—		—		4,102
Issuance for employee stock purchase plan	24,630		—		358	—		—		—		358
Vesting of RSUs and PSUs	413,538		—		—	—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs and PSUs	(135,562)		—		(3,508)	—		—		—		(3,508)
Stock-based compensation	—		—		6,879	—		—		—		6,879
Net income	—		—		—	—		—		15,662		15,662
Balance, March 31, 2021	35,203,824	$	35	$	482,197	—	$	—	$	(312,197)	$	170,035
Exercise of common stock options	273,127		1		4,092	—		—		—		4,093
Vesting of RSUs and PSUs	65,107		—		—	—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs and PSUs	(18,141)		—		(421)	—		—		—		(421)
Stock-based compensation	—		—		6,516	—		—		—		6,516
Net income	—		—		—	—		—		72,843		72,843
Balance, June 30, 2021	35,523,917	$	36	$	492,384	—	$	—	$	(239,354)	$	253,066
Exercise of common stock options	91,268		—		1,337	—		—		—		1,337
Issuance for employee stock purchase plan	19,089		—		397	—		—		—		397
Vesting of RSUs and PSUs	33,098		—		—	—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs and PSUs	(11,179)		—		(220)	—		—		—		(220)
Share repurchases	—		—		—	(859,040)		(17,480)		—		(17,480)
Stock-based compensation	—		—		5,948	—		—		—		5,948
Net income	—		—		—	—		—		8,046		8,046
Balance, September 30, 2021	35,656,193	$	36	$	499,846	(859,040)	$	(17,480)	$	(231,308)	$	251,094

Additional



Total

Common Stock

Paid- In

Accumulated

Shareholders’

Shares


Amount

Capital

Deficit

Equity (Deficit)
Balance, December 31, 2016
29,364,100

$
29

$
358,063

$
(223,184)

$
134,908
Exercise of common stock options
131,755

1

427

—

428
Issuance for employee stock purchase plan
110,841

—

1,141

—

1,141
Vesting of restricted stock units
14,757

—

—

—

—
Shares withheld for employee taxes upon vesting of restricted stock units
(4,819)

—

(68)

—

(68)
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507
1,148,466

1

11,454

—

11,455
Stock-based compensation
—

—

5,867

—

5,867
Net loss
—

—

—

(57,462)

(57,462)
Balance, September 30, 2017
30,765,100

$
31

$
376,884

$
(280,646)

$
96,269

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~~9. Stock-based Compensation~~

~~A summary of~~The changes in shareholders’ equity for the ~~Company’s stock-based compensation expense included in theCondensed Consolidated Statements of Operations are~~three and nine months ended September 30, 2020 were as follows:

Three months ended

Nine months ended

September 30,

September 30,

2017

2016

2017

2016
Research and development expenses
$
222

$
171

$
673

$
474
Selling, general and administrative expenses

1,878

1,470

5,194

3,663
Total stock-based compensation expense
$
2,100

$
1,641

$
5,867

$
4,137

At September 30, 2017, there was approximately $18,889 of unrecognized compensation expense related to unvested options, restricted stock units and restricted stock awards, which is expected to be recognized as expense over a weighted average period of approximately 2.7 years.


				Additional				Total
	Common Stock			Paid- In		Accumulated		Shareholders’
	Shares		Amount	Capital		Deficit		Equity
Balance, December 31, 2019	33,678,840	$	34	$	447,297	$	(359,899)	$	87,432
Exercise of common stock options	455,573		—		4,454		—		4,454
Issuance for employee stock purchase plan	39,411		—		357		—		357
Vesting of RSUs	195,280		—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs	(63,064)		—		(1,358)		—		(1,358)
Stock-based compensation	—		—		4,951		—		4,951
Equity component of 2020 Convertible Notes, net of issuance costs of $1,773	—		—		44,777		—		44,777
Net income	—		—		—		450		450
Balance, March 31, 2020	34,306,040		34		500,478		(359,449)		141,063
Exercise of common stock options	131,562		—		1,626		—		1,626
Vesting of RSUs	83,461		—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs	(26,761)		—		(564)		—		(564)
Stock-based compensation	—		—		5,584		—		5,584
Net income	—		—		—		8,058		8,058
Balance, June 30, 2020	34,494,302	$	34	$	507,124	$	(351,391)	$	155,767
Exercise of common stock options	21,726		1		313		—		314
Issuance for employee stock purchase plan	28,101		—		401		—		401
Vesting of RSUs	46,249		—		—		—		—
Shares withheld for employee taxes upon vesting of RSUs	(13,249)		—		(247)		—		(247)
Stock-based compensation	—		—		5,165		—		5,165
Net income	—		—		—		11,286		11,286
Balance, September 30, 2020	34,577,129	$	35	$	512,756	$	(340,105)	$	172,686

Common Stock

~~Restricted Stock Awards, Restricted Stock Units and Stock Options~~

In May 2015, the Company adopted the Amended and Restated 2014 Stock Incentive Plan (the “Plan”), under which an aggregate of 2,700,000 shares of common stock ~~are~~were authorized for issuance to employees, officers, directors, consultants

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and advisors of the Company, plus an annual increase on the first day of each fiscal year until the expiration of the Plan equal to 4% of the total number of outstanding shares of common stock on December ~~31st~~31^st of the immediately preceding calendar year (or a lower amount as otherwise determined by the Company’s board of directors (“Board of Directors”) prior to January ~~1st)~~1^st). As of September 30, ~~2017,~~2021, there were ~~1,142,277~~1,166,639 shares of common stock available for issuance pursuant to the Plan. The Plan provides for granting of both Internal Revenue Service qualified incentive stock options ~~(“ISOs”)~~ and non-qualified options, ~~(“NQs”),~~ restricted stock awards, ~~(“RSAs”)~~restricted stock units and performance stock units. The Company’s qualified incentive stock options, non-qualified options and restricted stock units ~~(“RSUs”). Stock options~~ generally vest ratably over a ~~four year~~four-year period of ~~service; however, certain options are also subject to performance conditions.~~service. The stock options generally have a ~~ten year~~ten-year contractual life and, upon termination, vested options are generally exercisable ~~between one and~~ three months following the termination date, while unvested options are forfeited ~~immediately.~~immediately upon termination. Refer to Note 13, Stock-based Compensation, for more information.

Warrants

As of September 30, 2021, the warrant issued to Assertio in November 2018 was the Company’s only outstanding warrant. In connection with the Third Amendment to the Nucynta Commercialization Agreement, the Company issued a warrant to Assertio to purchase 1,041,667 shares of common stock of the Company at an exercise price of $19.20 per share. The terms of the warrant are fixed, with the exception of customary adjustments for changes in the Company’s capitalization. The warrant may only be settled with the issuance of shares of common stock upon exercise and will expire in November 2022. The Company has recorded the relative fair value of the warrant as a component of equity interest issued by the Company as consideration transferred in the cost accumulation model for the asset acquisition. The

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Company estimated the fair value of the warrant on the date of issuance to be approximately $8,043 using the Black-Scholes option-pricing model. The Company concluded that the warrant met the definition of an equity instrument and was recorded as a component of additional paid-in capital in the Company’s Condensed Consolidated Balance Sheet as of the issuance date.

ShareRepurchases

InAugust 2021, the Company’s board of directors authorized a share repurchase program to repurchase up to $100,000 of outstanding shares of the Company’s common stock at any time or times through December 31, 2022 (the “Repurchase Program”). The Repurchase Program permits the Company to effect repurchases through a variety of methods, including open-market purchases (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, or otherwise in compliance with Rule 10b-18 of the Exchange Act. Shares repurchased under the Repurchase Program will return to the Company’s pool of authorized but unissued shares available for reissuance. The timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors. The Repurchase Program can be discontinued at any time. There can be no assurance as to the timing or number of shares of any repurchases in the future. As of September 30, 2021, $17,480 had been used to repurchase shares and $82,520 remained available for share repurchases under the Repurchase Program.

The table below summarizes the shares of the Company’s common stock that the Company repurchased under the Repurchase Program during the three and nine months ended September 30, 2021 and the cost of the shares received, which were recorded as Treasury Stock in the condensed consolidated Balance Sheet.


	Three months ended September 30,		Nine months ended September 30,
	2021		2021
Number of shares repurchased		859,040		859,040
Total cost of shares received	$	17,480	$	17,480

13. Stock-based Compensation

Performance Share Units, Restricted Stock Units and Stock Options

Performance Share Units

The Company periodically grants PSUs to certain members of the Company's senior management team. PSUs vest subject to the satisfaction of annual and cumulative performance and/or market conditions established by the Compensation Committee.

A summary of the Company’s ~~restricted stock award~~PSU activity for the nine months ended September 30, ~~2017~~2021 and related information is as follows:


		Weighted-Average
	Shares	Grant Date Fair Value
Outstanding at December 31, 2020	283,223	$	24.26
Granted	231,180		35.15
Vested	(66,974)		22.35
Forfeited	(81,720)		30.66
Performance adjustment	(12,609)		21.80
Outstanding at September 30, 2021	353,100	$	31.77

The number of PSUs granted represents the target number of shares of common stock that may be earned. However, the actual number of shares earned may vary based on the satisfaction of performance criteria. The weighted-average grant date fair value of PSUs granted for the nine months ended September 30, 2021 and 2020 was $35.15 and $28.49, respectively.

Weighted-Average

Purchase Price

Shares

per Share
Unvested at December 31, 2016

43,265

$
5.73
Granted

—

—
Vested

(24,336)

5.73
Unvested at September 30, 2017 (1)

18,929

$
5.73

~~(1)Excludes 25,657 shares of unvested restricted stock remaining from~~

Restricted Stock Units

The Company granted RSUs to employees for the ~~early exercise of stock options as of~~nine months ended September 30, ~~2017.~~

2021. The Company’s RSUs generally vest ratably over a four-year period of service. A summary of the Company’s ~~restricted stock units~~RSU activity for the nine months ended September 30, ~~2017~~2021 and related information is as follows:

Weighted-Average

Shares

Grant Date Fair Value
Outstanding at December 31, 2016

41,741

$
16.15
Granted

211,018

12.45
Settled

(14,757)

16.15
Forfeited

(19,130)

15.52
Outstanding at September 30, 2017

218,872

$
12.64


		Weighted-Average
	Shares	Grant Date Fair Value
Outstanding at December 31, 2020	1,242,387	$	19.42
Granted	1,339,731		24.35
Vested	(444,769)		19.17
Forfeited	(295,382)		22.31
Outstanding at September 30, 2021	1,841,967	$	22.61

The weighted-average grant date fair value per share of RSUs granted for the nine months ended September 30, 2021 and 2020 was $24.35 and $21.35, respectively. The total fair value of RSUs vested (measured on the date of vesting) for the nine months ended September 30, 2021 and 2020 was $11,165 and $6,797, respectively.

Stock Options

A summary of the Company’s stock option activity for the nine months ended September 30, 2021 and related information is as follows:

Weighted-

Weighted-

Average

Average

Remaining

Aggregate

Exercise Price

Contractual

Intrinsic


Shares


per Share

Term (in years)


Value

Outstanding at December 31, 2016

2,326,801

$
13.07

8.7

$
7,927

Granted

1,261,373

12.06

Exercised

(131,755)

3.25

Cancelled

(399,465)

13.62

Outstanding at September 30, 2017

3,056,954

$
13.00

8.6

$
3,604

Exercisable at September 30, 2017

940,101

$
12.80

7.8

$
1,727

Vested and expected to vest at September 30, 2017

2,909,114

$
13.08

8.5

$
3,571


				Weighted-
			Weighted-	Average
			Average	Remaining		Aggregate
			Exercise Price	Contractual		Intrinsic
	Shares		per Share	Term (in years)		Value
Outstanding at December 31, 2020	3,860,481	$	17.78	7.2	$	13,011
Granted	90,000		21.03
Exercised	(653,559)		14.59
Cancelled	(218,675)		20.31
Outstanding at September 30, 2021	3,078,247	$	18.37	6.3	$	8,434
Exercisable at September 30, 2021	2,326,929	$	18.21	5.7	$	6,992

The weighted-average assumptions used in the Black Scholes option pricing model to determine the fair value of ~~each~~the employee stock option ~~is estimated on the~~grants were as follows:


	Nine months ended September 30,
	2021		2020
Risk-free interest rate	0.7	%	1.3	%
Volatility	67.2	%	66.2	%
Expected term (years)	6.0		6.0
Expected dividend yield	—	%	—	%

The weighted-average grant date ~~using~~fair value per share of stock options granted for the ~~Black-Scholes option-pricing model using the following assumptions:~~nine months ended September 30, 2021 and 2020 was $12.60 and $12.78, respectively.

Nine months ended September 30,

2017

2016
Risk-free interest rate
2.0
%

1.5
%
Volatility
71
%

77
%
Expected term (years)
6.01

6.02

Expected dividend yield
—
%

—
%

Employee Stock Purchase Plan

The Company’s 2015 Employee Stock Purchase Plan allows employees ~~as designated by the Company’s Board of Directors~~ to purchase shares of the Company’s common stock. The purchase price is equal to 85% of the lower of the closing price of ~~our~~the Company’s common stock on (1) the first day of the purchase period or (2) the last day of the purchase period. During the nine months ended September 30, ~~2017, 110,841~~2021, 43,719 shares of common stock were purchased for total proceeds of ~~$1,141.~~$755. The expense for the

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three months ended September 30, ~~2017~~2021 and ~~2016~~2020 was ~~$74~~$58 and ~~$143,~~$89, respectively. The expense for the nine months ended September 30, ~~2017~~2021 and ~~2016~~2020 was ~~$288~~$195 and ~~$311,~~$260, respectively.

Stock-based Compensation Expense

~~Table~~A summary of ~~Contents~~

the Company’s stock-based compensation expense was allocated as follows:

~~10.~~


	Three months ended September 30,				Nine months ended September 30,
	2021		2020		2021		2020
Research and development	$	233		1,019	$	2,697		2,773
Selling, general and administrative		5,715		4,146		16,646		12,927
Total stock-based compensation expense	$	5,948	$	5,165	$	19,343	$	15,700

At September 30, 2021, there was approximately $45,947 of unrecognized compensation expense related to unvested options, restricted stock units and performance stock units, which is expected to be recognized as expense over a weighted average period of approximately 2.5 years.

14. Commitments and Contingencies

Legal Proceedings

From time to time, the Company may face legal claims or actions in the normal course of business. Except as disclosed below, the Company is not currently a party to any litigation and, accordingly, does not have any amounts recorded for any litigation related matters.

Xtampza ER Litigation

The ~~Company’s~~Company filed the NDA ~~filing~~ for Xtampza isER as a 505(b)(2) application, which allows the Company to reference data from an approved drug listed in the FDA’s ~~Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the “Orange Book”),~~Orange Book, in this case ~~OxyContin OP. In connection with the~~OxyContin. The 505(b)(2) process requires that the Company ~~certified~~certify to the FDA ~~and notified~~that the Company does not infringe any of the patents listed for OxyContin in the Orange Book, or that the patents are invalid. The process also requires that the Company notify Purdue Pharma, ~~L.P.~~L.P (“Purdue”), as the holder of the NDA, and any other Orange Book-listed patent owners that it has made such a certification. On February 11, 2015, the Company made the required certification documenting why Xtampza ER does not infringe any of the 11 Orange Book listed patents ~~listed~~ for OxyContin, OP5 of which have been invalidated in court proceedings, and provided the ~~Orange Book.~~required notice to Purdue. Under the ~~Hatch-Waxman~~Drug Price Competition and Patent Term Restoration Act of 1984, ~~(the “Hatch-Waxman Act”),~~ Purdue had the option to sue the Company for infringement and receive a stay of up to 30 months before the FDA could issue a final ~~regulatory~~ approval for Xtampza ER, unless the stay was earlier terminated.

In response to these actions, Purdue ~~exercised its option and elected to sue~~sued the Company for infringement in the District of Delaware inon March 24, 2015 asserting infringement of ~~three~~3 of Purdue’s Orange ~~Book~~‑~~listed~~Book-listed patents (Patent Nos. 7,674,799, 7,674,800, and ~~one~~7,683,072) and a non-Orange Book-listed ~~patent. In October 2015,~~patent (Patent No. 8,652,497), and accordingly, received a 30-month stay of FDA approval.

The Delaware court transferred the ~~Delaware~~ case ~~was transferred~~ to the District of Massachusetts. After the Company filed a partial motion for judgment on the pleadings relating to the Orange Book-listed patents, the District Court of Massachusetts ordered judgment in ~~favor of~~ the ~~Company~~Company’s favor on those ~~three~~3 patents, and dismissed the claims asserting infringement of those patents with prejudice. Upon dismissal of those claims, the 30-month stay of FDA approval was lifted. As a result, the Company ~~obtained~~was able to obtain final approval ~~of its~~for Xtampza ER ~~products~~ and ~~has launched~~launch the ~~products~~product commercially.

~~In November 2015,~~Purdue subsequently filed 2 follow-on lawsuits asserting infringement of 2 patents that had been late-listed in the Orange Book and therefore could not trigger any stay of FDA approval: Purdue filed ~~a follow-on~~ suit asserting infringement of ~~another patent,~~ Patent No. 9,073,933 in November 2015, and asserted infringement of Patent No. 9,522,919 in April 2017. In addition, Purdue filed suit on 2 patents that had not been listed in the Orange Book, filing suit in June 2016 asserting infringement of Patent No. 9,155,717 and in September 2017, asserting infringement of Patent No. 9,693,961.

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On March 13, 2018, the Company filed a Petition for Post-Grant Review (“PGR”) of the ʼ961 patent with the Patent Trial and Appeal Board (“PTAB”). The PGR argues that the ʼ961 patent is invalid for lack of a written description, for lack of enablement, for indefiniteness, and as being anticipated by prior art. The PTAB held oral argument on the proceedings on July 10, 2019 and was scheduled to issue a decision on the patentability of the ʼ961 patent by no later than October 4, 2019. On September 15, 2019, Purdue commenced a voluntary case under chapter 11 of title 11 of the United States Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York. On September 24, 2019, Purdue gave the PTAB notice of its bankruptcy filing and sought the imposition of an automatic stay of the PGR proceedings. On October 2, 2019, the PTAB extended the one-year period for issuing its decision by up to six months.

In October 2017, and in response to the filing of the Company’s Supplemental NDA (“sNDA”) seeking to update the drug abuse and dependence section of the Xtampza ER label, Purdue filed another suit asserting infringement of the ʼ933 and ʼ919 patent. The Company filed a motion to dismiss that action, and the Court granted its motion on January 16, 2018.

A claim construction hearing was held on June 1, 2017. On November 21, 2017, the Court issued its claim construction ruling, construing certain claims of the ʼ933, ʼ497, and ʼ717 patents. The Court issued an order on September 28, 2018 in which it granted in part a motion for summary judgment that the Company filed. Specifically, the Court ruled that the Xtampza ER formulation does not infringe the ʼ497 and ʼ717 patents. On September 18, 2019, Purdue gave the Court notice of its bankruptcy filing and sought the imposition of an automatic stay of the proceedings. On September 20, 2019, the matter was stayed pending further order of the Court.

On September 1, 2020, the Bankruptcy Court entered an Order Granting Motions for Relief from the Automatic Stay, lifting the automatic stays in both the District of Massachusetts and PTAB proceedings. The Company appealed the Bankruptcy Court’s Order, in part, and that appeal is stayed, on consent by Purdue, pending the outcome of the PTAB proceedings and any appeal thereto. On September 11, 2020, Purdue filed a motion to terminate the PTAB action on the basis that those proceedings had gone beyond the 18-month statutory period. The Company opposed Purdue’s motion. On June 28, 2021, the Company advised the PTAB that District Court litigation on the ‘961 patent had resumed but that District Court Judge Saylor had expressed interest in a decision of the PTAB and stated the Court did not want the PTAB to drop the PGR in favor of the District Court Litigation. On October 8, 2021, the PTAB advised the parties that the PGR panel expects to issue a paper in the PGR proceeding within one month.

On April 2, 2021, the Court granted Purdue’s Motion to Lift the Stay in the District of Massachusetts that was entered following Purdue’s Notice of Bankruptcy. On April 9, 2021, Purdue filed another follow-on lawsuit asserting infringement of U.S. Patent No. 10,407,434, which was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval. ~~In June 2016,~~The Company responded to Purdue’s complaint asserting the ’434 patent with a motion to dismiss. On May 21, 2021, and in response to the Company’s motion to dismiss, Purdue filed ~~another~~an amended complaint asserting the ’434 patent. The Company renewed its motion to dismiss on June 4, 2021, arguing: (i) Purdue cannot, as a matter of law, state a claim for infringement under § 271(e)(2)(A); (ii) Purdue cannot, as a matter of law, state a claim for product-by-process infringement under §271(g); and (iii) Purdue has not alleged facts sufficient to support any indirect infringement theory under §271(b) or (c). The Court held a hearing on the Company’s motion to dismiss on October 13, 2021, and the motion is pending before the Court.

Like the prior follow-on ~~suit asserting infringement~~lawsuits, the ’434 patent litigation was consolidated into the lead case and a scheduling order was entered. On October 5, 2021, the Court held a claim construction hearing for the ʼ961 patent and the ʼ434 patent. The scheduling order set the fact discovery deadline on March 11, 2022, and an expert discovery deadline of ~~another non-Orange Book listed patent, Patent No. 9,155,717. These suits were~~May 17, 2022. The court has not set a deadline for dispositive motions or trial.

The remaining patents-in-suit in the lead consolidated byaction in the District of Massachusetts ~~into~~are the original action where Purdue’s infringement claim relating to the ’497 patent remains pending. Purdue continues to assert infringement of these three patents against the Company, none of which is associated with any stay of FDA approval.ʼ933, ʼ919, ʼ434, and ʼ961 patents. Purdue has made a demand for monetary relief, ~~but has not quantified their alleged damages. Purdue has also~~and requested a judgment of infringement, an adjustment of the effective date of FDA approval, and an injunction on the sale of the Company’s products accused of infringement. The Company has denied all claims and ~~seeks~~has requested a judgment that the remaining asserted patents are invalid and/or not ~~infringed by~~infringed; the Company ~~and seeks~~is also seeking a judgment that the case is exceptional ~~with~~and has requested an award toof the ~~Company of its~~Company’s attorneys’ fees for defending the case.

In April 2017, Purdue filed another suit asserting infringement of U.S. Patent No. 9,522,919, related to the previously asserted ’933 patent, which recently issued and was late-listed in the Orange Book and therefore could not trigger any stay of FDA approval. Purdue has similarly made a demand for monetary relief and has requested judgment of infringement and an injunction on the sale of the Company’s accused products. The Company will oppose this action.

In September 2017, Purdue filed another suit in the United States District Court, District of Massachusetts, asserting infringement of U.S. Patent No. 9,693,961 (the “’961” patent). The ʼ961 patent is not Orange Book-listed and is unrelated to the patents asserted in the lead case. Because the ʼ961 patent is not Orange Book-listed, it cannot trigger any stay of FDA approval. Purdue has similarly made a demand for monetary relief and has requested judgment of infringement and an injunction on the sale of the Company’s accused products. The Company has not yet filed an answer or otherwise responded to this Complaint.

In October 2017, and in response to the filing of the Company’s supplemental New Drug Application (“NDA”), Purdue filed another suit in the United States District Court, District of Massachusetts, asserting infringement of the ʼ933 and ʼ919 patent. At this time, it is unclear if the suit will trigger an additional stay of FDA approval of the Company’s label change proposed by its supplemental NDA. The Company has not yet filed an answer or otherwise responded to this Complaint.

Purdue continues to assert infringement of four remaining patents by the Company in the lead case, which are the ʼ919 patent, the ʼ933 patent, U.S. Patent No. 8,652,497, U.S. and U.S. Patent No. 9,155,717.

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The parties are in the early stages of fact discovery. Written discovery has commenced with depositions expected to commence in the fourth quarter of 2017. The parties are also in the claims construction stage of the patent litigation. The parties have briefed their proposed construction. The Company has also filed a motion for summary judgment that the asserted claims of the ’933, ’497, and ’717 patents are invalid and not infringed. The Court heard argument on the claims construction issues and on the Company’s summary judgment motion on June 1, 2017. The Company is not able to predict with certainty when the Court will decide claim construction or the Company’s motion. No trial date has been scheduled.

The Company ~~is, and~~ plans to ~~continue, defending~~defend this case vigorously. At this stage, ~~we are~~the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any.

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Nucynta Litigation

On February 7, 2018, Purdue filed a patent infringement suit against the Company in the District of Delaware. Specifically, Purdue argues that the Company’s sale of immediate-release and extended-release Nucynta infringes U.S. Patent Nos. 9,861,583, 9,867,784, and 9,872,836. Purdue has made a demand for monetary relief in its complaint but has not quantified its alleged damages.

On December 6, 2018, the Company filed an Amended Answer asserting an affirmative defense for patent exhaustion. On December 10, 2018, the Court granted the parties’ stipulation for resolution of the Company’s affirmative defense of patent exhaustion and stayed the action, with the exception of briefing on and resolution of the Company’s Motion for Judgment on the Pleadings related to patent exhaustion and any discovery related to that Motion. Also, on December 10, 2018, the Company filed a Rule 12(c) Motion for Judgment on the Pleadings, arguing that the Purdue’s claims were barred by the doctrine of patent exhaustion. On June 18, 2019, the Court heard oral argument on the Company’s Rule 12(c) Motion for Judgment on the Pleadings. On June 19, 2019, the Court issued an order stating that “judgment in Collegium’s favor is warranted under the doctrine of patent exhaustion to the extent Collegium’s alleged infringing activities resulted from sales that fall within the scope of that covenant.” The Court explained, however, that based on the current record, it was not possible “to determine whether title of the Nucynta Products was transferred to Collegium” from sales authorized by Purdue’s covenant not to sue. The Court ordered discovery on this issue and the case remained “stayed with the exception of discovery and briefing on and resolution of the Company’s anticipated motion for summary judgment based on patent exhaustion.”

On September 19, 2019, Purdue gave the Court notice of its bankruptcy filing and sought the imposition of an automatic stay of the proceedings. The Nucynta litigation is subject to the automatic bankruptcy stay.

Pending resolution of the bankruptcy action, the Company plans to defend this case vigorously. At this ~~time~~stage, the Company is unable to ~~provide meaningful quantification~~evaluate the likelihood of ~~how this~~an unfavorable outcome or estimate the amount or range of potential ~~litigation may impact its future financial condition, results of operations, or cash flows.~~

loss, if any.

Opioid Litigation

As a result of the opioid epidemic, numerous state and local governments, healthcare providers, and other entities have brought suit against manufacturers, wholesale distributors, and pharmacies alleging a variety of claims related to opioid marketing and distribution practices. In late 2017, the U.S. Judicial Panel on Multidistrict Litigation ordered the consolidation of what were then a few hundred cases pending around the country in federal court against opioid manufacturers and distributors into a Multi-District Litigation (MDL) in the Northern District of Ohio. Currently, the Opioid MDL consists of over 2,000 opioid-related cases brought primarily by states, cities, counties, and other local entities. Generally speaking, these suits do not seek damages for injuries to individuals but rather compensation for the cost of public services needed to address the consequences of addicted communities, ranging from emergency response capabilities to rehabilitation services. The Company has been named as a defendant in a small subset of the MDL cases. Of the 21 MDL cases that have named the Company as a defendant, the allegations against it have been dismissed or withdrawn in 13 cases. In addition, the Company has been dismissed from 3 non-MDL cases filed in Pennsylvania and Arkansas state courts.

NaN cases that name the Company as a defendant, originally filed in 3 states, remain pending in the MDL:

Virginia. On January 11, 2019, the City of Portsmouth filed a lawsuit in Virginia Circuit Court against the Company and other pharmaceutical manufacturers and distributors. The lawsuit alleges a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, and violations of state consumer protection laws. On October 3, 2019, the City of Portsmouth case was transferred to the MDL.

New Jersey. On March 15, 2019, the Company was named in a lawsuit in the MDL by the City of Paterson, New Jersey. The lawsuit alleges violations of fraud, public nuisance, negligent misrepresentation, and violations of state consumer protection laws, and seeks, generally, penalties and/or injunctive relief. On June 14, 2019, the City of Trenton filed a lawsuit in the New Jersey Superior Court against the Company and other pharmaceutical manufacturers and distributors. The lawsuit alleges a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, and violations of state consumer protection laws and the New Jersey Drug Dealer Liability Act. On

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December 18, 2019, the case was transferred to the MDL.

Connecticut. On April 9, 2019, the City of Norwich, Connecticut and the Town of Enfield, Connecticut filed lawsuits that name the Company in Connecticut Superior Court. The lawsuits allege violations of fraud, public nuisance, negligent misrepresentation, and violations of state consumer protection laws. On June 28, 2019, both cases were transferred to the MDL. In October 2019, the Company was named in 2 additional Connecticut lawsuits: the City of Middletown and the Town of Wethersfield. These cases were both also transferred to the MDL in July 2019. Finally, on January 15, 2020, the Town of Windham, Connecticut filed a lawsuit that names the Company, among other pharmaceutical manufacturers, in Connecticut Superior Court. The lawsuit alleges violations of fraud, public nuisance, negligent misrepresentation, and violations of state consumer protection laws. On March 3, 2020, the lawsuit was transferred to the MDL.

Each of the lawsuits in the MDL naming the Company seeks, generally, penalties and injunctive relief. NaN of the lawsuits naming the Company are designated as representative cases in the MDL, and therefore, are effectively currently stayed.

Outside of the MDL, there are several cases pending against the Company in state courts in Pennsylvania and Massachusetts:

In Pennsylvania, 6 lawsuits naming the Company have been consolidated for discovery purposes in the Delaware County Court of Common Pleas as part of a consolidated proceeding of similar lawsuits brought by numerous Pennsylvania counties against other pharmaceutical manufacturers and distributors. These include lawsuits filed between May 2018 and July 2019 on behalf of Bucks County, Clinton County, Mercer County, Warrington Township, Warminster Township, and the City of Lock Haven, each of Pennsylvania, alleging claims related to opioid marketing and distribution, including negligence, fraud, unjust enrichment, public nuisance, and violations of state consumer protections laws. NaN of these cases has been designated a Track One case in which discovery would commence, and therefore they are all effectively stayed at present.

In Massachusetts, there are lawsuits by the City of Worcester, the City of Salem, the City of Framingham, the Town of Lynnfield, the City of Springfield, the City of Haverhill, the City of Gloucester, the Town of Canton, the Town of Wakefield, the City of Chicopee, the Town of Natick, the City of Cambridge and the Town of Randolph, all of which have been consolidated before the Business Litigation Session of the Superior Court. The actions allege a variety of claims related to opioid marketing and distribution practices including public nuisance, common law fraud, negligent misrepresentation, negligence, violations of Mass Gen. Laws ch. 93A, Section 11, unjust enrichment and civil conspiracy. The case brought by the City of Springfield was selected to advance for the purpose of motion practice, defendants’ motions to dismiss were denied on January 3, 2020. There is no trial date set for this case.

The Company disputes the allegations in these lawsuits and intends to vigorously defend these actions. At this stage, the Company is unable to evaluate the likelihood of an unfavorable outcome or estimate the amount or range of potential loss, if any.

Opioid-Related Request and Subpoenas

The Company, like a number of other pharmaceutical companies, has received subpoenas or civil investigative demands related to opioid sales and marketing. The Company has received such subpoenas or civil investigative demands from the Offices of the Attorney General of each of Washington, New Hampshire, Maryland and Massachusetts. The Company is currently cooperating with each of the foregoing states in their respective investigations.

15. Income Taxes

The Company is subject to U.S. federal and state income taxes. The income tax provision for interim periods reflects the Company’s estimate of the annual effective tax rate expected to be applicable for the full fiscal year, adjusted for any discrete events which are recorded in the period in which they occur.

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The following table presents information regarding Company’s income tax (benefit) provision recognized for the three and nine months ended September 30, 2021 and 2020:


	Three months ended September 30,				Nine months ended September 30,
		2021		2020		2021		2020
Provision for (benefit from) income taxes	$	991	$	280	$	(61,049)	$	526
Effective tax rate		11.0%		2.4%		(172.0)%		2.6%

The Company provides a valuation allowance when it is more likely than not that deferred tax assets will not be realized. In determining the extent to which a valuation allowance for deferred tax assets is required, the Company evaluates all available evidence including projections of future taxable income, carry back opportunities, reversal of certain deferred tax liabilities, and other tax planning strategies. Prior to generating income during the year ended December 31, 2020, the Company had a history of operating losses and a valuation allowance was maintained on the majority of the Company’s deferred tax assets through March 31, 2021.

As a result of sustained positive earnings history through cumulative earnings over the last three years, as of June 30, 2021, the Company began using projections of future taxable income as a source of realizing its deferred tax assets. Accordingly, the Company released the portion of the valuation allowance on deferred tax assets expected to be realized through future earnings in the three months ended June 30, 2021. The Company recognized a discrete deferred tax benefit of $63,026 in the nine months ended September 30, 2021. The net operating losses expected to be recovered through ordinary income in the year ended December 31, 2021 are included in the annual effective tax rate. Changes in estimates of the portion of the operating losses expected to be recovered in the current year will impact the annual effective tax rate in the applicable period. The Company has maintained a valuation allowance on the portion of its deferred tax assets that are not more likely than not to be realized due to tax limitation or other conditions of $1,966 as of September 30, 2021.

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis of our financial condition and results of operations together with our condensed consolidated financial statements and related notes appearing elsewhere in this ~~quarterly report.~~Quarterly Report on Form 10-Q, and in conjunction with management’s discussion and analysis and our audited consolidated financial statements included in our most recent Annual Report. The following discussion contains forward-looking statements that involve risks uncertainties and assumptions. Our actual results and the timing of certain events could differ materially from those anticipated in these forward-looking statements as a result of many factors. We discuss factors that we believe could cause or contribute to these differences below and elsewhere in this ~~quarterly report,~~Quarterly Report on Form 10-Q, including those set forth under “Forward-looking Statements” and “Risk Factors”, ~~under the heading “Risk Factors” in the Company’s Annual Report,~~ as revised and supplemented by those risks described from time to time in other reports which we file with the SEC.

OVERVIEW

We are a specialty pharmaceutical company ~~developing and commercializing next-generation abuse-deterrent products that incorporate our patented DETERx platform technology for~~committed to being the ~~treatment of chronic~~leader in responsible pain ~~and other diseases.~~management. Our ~~first product,~~portfolio includes Xtampza isER, an abuse-deterrent, extended-release, oral formulation of oxycodone, ~~a widely prescribed opioid medication. In~~and Nucynta ER and Nucynta IR (collectively, the “Nucynta Products”), which are extended-release (“ER”) and immediate-release (“IR”) formulations of tapentadol.

Xtampza ER was approved by the FDA in April 2016 ~~the U.S. Food and Drug Administration, or FDA, approved our New Drug Application, or NDA, filing for Xtampza~~ for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. ~~Certain human abuse potential studies are included~~We commercially launched Xtampza ER in ~~the approved label, as well as data supporting the administration of the product as a sprinkle or administered through feeding tubes. In~~ June 2016, we announced the commercial launch of Xtampza. In October 2016, we announced the submission of a New Drug Submission to Health Canada seeking marketing approval of Xtampza for the same indication for which we obtained approval from the FDA.2016.

~~Xtampza has the same active ingredient as OxyContin OP, which~~Nucynta ER is the largest selling abuse-deterrent, extended-release opioid in the United States by dollars, with $2.1 billion in U.S. sales in 2016. We conducted a comprehensive preclinical and clinical program for Xtampza consistent with FDA guidance on abuse-deterrence. These studies and clinical trials demonstrated that chewing, crushing and/or dissolving Xtampza, and then taking it orally or smoking, snorting, or injecting it did not meaningfully change its drug release profile or safety characteristics. By contrast, clinical trials performed by us and others — including head-to-head clinical trials comparing Xtampza with OxyContin OP — have shown that drug abusers can achieve rapid release and absorption of the active ingredient by manipulating OxyContin OP using common household tools and methods commonly available on the Internet. In October 2016, we announced the submission of a Supplemental New Drug Application to the FDA for Xtampza to include comparative oral pharmacokinetic data from a recently completed clinical study evaluating the effect of physical manipulation by crushing Xtampza compared with OxyContin OP and a control (oxycodone hydrochloride immediate-release). In March 2017, we amended the Supplemental New Drug Application to include data from a human abuse potential study. In November 2017, the FDA approved our Supplemental New Drug Application. The updated Xtampza label includes: comparative pharmacokinetic data, results from an oral human abuse potential study and an oral abuse deterrent claim.

In addition, our preclinical studies and clinical trials have shown that the contents of the Xtampza capsule can be removed from the capsule and sprinkled on food or into a cup, and then directly into the mouth, or administered through feeding tubes, without compromising their drug release profile, safety or abuse-deterrent characteristics. By contrast, OxyContin OP, which is formulated in hard tablets, has a black box warning label stating that crushing, dissolving, or

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chewing can cause rapid release and absorption of a potentially fatal dose of the active ingredient. We believe that Xtampza can address the pain management needs of the approximately 11 million patients in the United States who suffer from chronic pain and have difficulty swallowing.

In May 2016, we entered into a License and Development Agreement with BioDelivery Science International, Inc., which grants us an exclusive license to make, use, sell, offer for sale, import, develop and commercialize Onsolis in the United States. Onsolis is a Transmucosal Immediate-Release Fentanyl film indicated for the management of ~~breakthrough~~ pain severe enough to require daily, around-the-clock, long-term opioid treatment, including neuropathic pain associated with diabetic peripheral neuropathy in ~~cancer patients 18 years~~adults, and for which alternate treatment options are inadequate. Nucynta IR is indicated for the management of ~~age~~acute pain severe enough to require an opioid analgesic and ~~older, who~~for which alternative treatments are ~~already receiving~~inadequate in adults. We began shipping and ~~who are tolerant to opioid therapy for their underlying persistent cancer pain.~~ recognizing product sales on the Nucynta Products on January 9, 2018 and began marketing the Nucynta Products in February 2018.

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We ~~plan~~initially licensed the right to commercialize ~~Onsolis upon receipt of FDA approval of~~the Nucynta Products in the United States through a ~~Prior Approval Supplement for the manufacturing transfer. Subject~~Commercialization Agreement with Assertio Therapeutics, Inc. (formerly known as Depomed) (“Assertio”) entered into in December 2017 (the “Nucynta Commercialization Agreement”). On February 13, 2020, we closed an Asset Purchase Agreement with Assertio (the “Nucynta Purchase Agreement”), pursuant to ~~such approval,~~which we ~~expect~~agreed to ~~launch Onsolis in mid-2018.~~

~~Since 2010, we have devoted substantially all of our resources~~acquire from Assertio certain assets related to the ~~development~~Nucynta Products (the “Nucynta Acquisition”), including the license from Grünenthal GmbH (“Grünenthal”), for an aggregate purchase price of $375.0 million. Upon closing, the Nucynta Commercialization Agreement was effectively terminated. Our prior royalty obligation to Assertio ceased and our ~~patented DETERx platform technology,~~only remaining royalty obligation is to pay 14% of net sales of the ~~preclinical~~Nucynta Products directly to Grünenthal.

For the nine months ended September 30, 2021, we generated $249.5 million in net revenues, comprised of $98.4 million from sales of Xtampza ER and ~~clinical advancement~~$151.1 million from sales of ~~our product candidates, pre-commercialization activities and~~ the creation and protection of related intellectual property. Since 2011, we have generated limited revenue from product sales and we continue to incur significant research, development and other expenses related to our ongoing operations. Prior to our initial public offering of common stock, or IPO, in May 2015, we funded our operations primarily through the private placement of preferred stock, convertible notes and commercial bank debt. Since our IPO, we have funded our operations primarily through the proceeds of public offerings and sale of our equity securities.Nucynta Products.

Outlook

We expect to continue to incur significant commercialization expenses related to marketing, manufacturing, distribution, selling and reimbursement activities. We are ~~detailing~~promoting Xtampza ER to approximately ~~10,400 physicians~~11,000 health care professionals who write approximately ~~60%~~65% of the branded extended-release oral opioid prescriptions in the United States with a sales team of approximately ~~170~~138 sales ~~representatives. In addition,~~representatives and managers. We are promoting the Nucynta Products to the same health care professionals to whom we ~~deploy a separate, focused~~promote Xtampza ER, leveraging our existing sales ~~team~~organization. We have historically paid royalties to ~~detail Xtampza to nursing homes, hospices and other institutions treating large populations~~Assertio on all revenues from the sale of Nucynta Products based on certain net sales thresholds. Upon the closing of the ~~elderly~~Nucynta Acquisition and ~~other patients who need chronic pain relief~~the termination of the Nucynta Commercialization Agreement (except for certain sections that survive in accordance with the Nucynta Purchase Agreement) in February 2020, our prior royalty obligation to Assertio ceased and ~~have difficulty swallowing.~~our only remaining royalty obligation is to pay 14% of net sales of the Nucynta Products directly to Grünenthal.

We ~~have never been~~were historically not profitable and ~~have~~ incurred net losses in each year since ~~inception.~~inception until 2020. We ~~incurred~~generated net ~~losses~~income of ~~$57.5~~$96.6 million ~~and $66.6 million for~~in the nine months ended September 30, ~~2017 and 2016, respectively.~~2021. As of September 30, ~~2017,~~2021, we had an accumulated deficit of ~~$280.6~~$231.3 million. Substantially all of our net losses resulted from costs incurred in connection with ~~our research and development programs and from~~ selling, general and administrative costs associated with our ~~operations. We expect to continue to incur net losses in the foreseeable future as we continue to commercialize Xtampza. Our net losses may fluctuate significantly from quarter to quarter~~operations and ~~year to year. We expect our expenses will increase in connection with our ongoing activities as we:~~

~~expand our sales and marketing efforts for Xtampza, including hiring additional personnel to expand our commercial organization;~~

~~expand our regulatory and compliance functions;~~

~~conduct clinical trials of our product candidates;~~

~~continue scale-up and improvement of our manufacturing processes;~~

~~continue our research and development efforts;~~

~~manufacture preclinical study and clinical trial materials;~~

~~maintain, expand and protect our intellectual property portfolio;~~

~~seek regulatory approvals for our product candidates that successfully complete clinical trials;~~

~~hire additional clinical, quality control and technical personnel to conduct our clinical trials;~~

~~hire additional scientific personnel to support our product development efforts;~~

~~implement operational, financial and management systems; and~~

~~hire additional selling, general and administrative personnel to operate as a commercial stage public company.~~

research and development programs.

We believe that our cash and cash equivalents at September 30, ~~2017,~~2021, together with expected cash inflows from the commercialization of ~~Xtampza, as well as proceeds from~~ our ~~ATM offering through October 2017,~~products, will enable us to fund our operating expenses, debt service and capital expenditure requirements ~~into mid-2019. In addition,~~under our current business plan for the foreseeable future.

As of the date of the filing of this Quarterly Report on Form 10-Q, we ~~will seek~~expect the COVID-19 pandemic and actions taken to contain it to continue to impact our revenue. Notwithstanding the lifting of COVID-19 restrictions in many jurisdictions, and amidst continuing public health concerns relating to the ~~future~~spread of COVID-19, weekly pain patient office visits continue to ~~fund our operations through additional public or private equity or debt financings or other sources, including from net sales of~~be depressed compared to pre-COVID periods, which in turn may account for fewer patients beginning therapy with our products. ~~However, we may be unable~~We believe that the disruptions caused by COVID-19 will continue and there remains substantial uncertainty as to ~~raise additional funds or enter into~~when such ~~other~~

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~~arrangements when needed on favorable terms or at all. If we are unable to obtain financing or increase profitability, the related lack of liquidity~~disruptions will ~~have a material adverse effect on our operations and future prospects.~~cease.

CRITICAL ACCOUNTING POLICIES AND ~~SIGNIFICANT JUDGMENTS AND~~ ESTIMATES

We believe that several accounting policies are important to understanding our historical and future performance. We refer to these policies as “critical” because these specific areas generally require us to make judgments and estimates about matters that are uncertain at the time we make the estimate, and different estimates—which also would have been reasonable—could have been used, which would have resulted in different financial results.

The critical accounting policies we identified in our Annual Report relate to revenue recognition ~~inventory, accrued expenses,~~and impairment of ~~long-lived assets, stock-based compensation and income taxes.~~intangible assets. Estimates include revenue recognition, including the estimates of valid product returns within the return window defined by the Company’s policy, units prescribed, discounts and allowances related to commercial sales of ~~Xtampza,~~our products, estimates utilized in the valuation of inventory, estimates of useful lives with respect to intangible assets, accounting for stock-based compensation, contingencies, intangible assets and tax valuation ~~reserves and accrued expenses. We have also identified the estimate of product returns as a significant estimate in the interim period ended September 30, 2017.~~allowances. We base our estimates and assumptions on historical experience when available and on various factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and weliabilities that are not readily apparent from other sources. We evaluate our estimates and assumptions on an ongoing basis. ~~Our actual~~Actual results may differ from these estimates under different assumptions or conditions. It is important that the

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discussion of our operating results that follows be read in conjunction with the critical accounting policies disclosed in our Annual Report.

~~Revenue Recognition~~

Revenue for product sales is recognized when there is persuasive evidence of an arrangement, title and risk of loss have passed to the customer, which generally occurs upon delivery, when estimated provisions for chargebacks, rebates, sales incentives and allowances, distribution service fees, and returns are reasonably determinable, and when collectability is reasonably assured. Product sales are recorded net of estimated chargebacks, rebates, sales incentives and allowances, distribution service fees, as well as estimated product returns.

~~Beginning in the third quarter of 2017, we determined that we have sufficient experience with sales of~~ ~~Xtampza~~ ~~to estimate returns at time of shipment. We sell our products primarily to distributors and retailers, or customers, which in turn sell the product to pharmacies for the treatment of patients.We provide the right of return to our customers for a limited time before and after its expiration date.~~ ~~As a result of our experience to date with~~ ~~Xtampza,~~ we determined that we can reasonably estimate the amount of future product returns. The effect on income from operations and on net income is that we are able to recognize revenue earlier on the sell-in method, net of a provision for estimated returns, because we can record revenue once sold to the customer rather than waiting until the product is sold to the end user on a sell-through method. The Company recorded a one-time $4.4 million increase to revenues during the three months ended September 30, 2017 as a result of the Company’s change to the sell-in method in the third quarter of 2017.

RESULTS OF OPERATIONS

~~(in thousands)~~


									Three months ended September 30,				Nine months ended September 30,
									2021		2020		2021		2020

	Three months ended September 30,				Nine months ended September 30,
	2017		2016		2017		2016
	(in thousands)
									(in thousands)					(in thousands)
Product revenues, net	$	11,950	$	408	$	17,682	$	408	$	78,843	$	79,176	$	249,506	$	233,745
Cost of product revenues		553		29		1,501		29
Cost of product revenues (excluding intangible asset amortization)										15,934		14,188		47,170		54,316
Intangible asset amortization										16,796		16,795		50,386		43,885
Total cost of products revenues										32,730		30,983		97,556		98,201
Gross profit										46,113		48,193		151,950		135,544
Operating expenses
Research and development		2,069		3,254		6,378		11,617		1,450		2,141		7,842		7,300
Selling, general and administrative		22,758		23,567		67,667		55,266		30,514		26,426		92,358		87,008
Interest income (expense), net		167		(2)		402		(113)
Net loss	$	(13,263)	$	(26,444)	$	(57,462)	$	(66,617)
Total operating expenses										31,964		28,567		100,200		94,308
Income from operations										14,149		19,626		51,750		41,236
Interest expense										(5,115)		(8,063)		(16,257)		(21,145)
Interest income										3		3		9		229
Income before income taxes										9,037		11,566		35,502		20,320
Provision for (benefit from) income taxes										991		280		(61,049)		526
Net income									$	8,046	$	11,286	$	96,551	$	19,794

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Comparison of the three months ended September 30, ~~2017~~2021 and September 30, ~~2016~~2020

Product revenues, net were ~~$12.0~~$78.8 million for the three months ended September 30, ~~2017, or the 2017 Quarter,~~2021 (the “2021 Quarter”), compared to ~~$408,000~~$79.2 million for the three months ended September 30, ~~2016, or~~2020 (the “2020 Quarter”). The $400,000 decrease was related to a decrease in revenue for Xtampza of $2.1 million, partially offset by an increase in revenue for the ~~2016~~Nucynta Products of $1.7 million. For the 2021 Quarter, Xtampza ER product revenues, net were $30.0 million, compared to $32.1 million for the 2020 Quarter. The ~~$11.6~~decrease in revenue for Xtampza ER was primarily related to higher gross-to-net adjustments, partially offset by an increase in sales volume and gross price. For the 2021 Quarter, Nucynta IR and ER product revenues, net were $29.1 million and $19.7 million, respectively, compared to $30.0 million and $17.1 million, respectively, for the 2020 Quarter. The increase in revenue for the Nucynta Products was primarily related to a benefit from lower gross-to-net adjustments and an increase in gross price, partially offset by lower sales volume.

Cost of product revenues (excluding intangible asset amortization) was $15.9 million for the 2021 Quarter, compared to $14.2 million for the 2020 Quarter. The $1.7 million increase was primarily related to ~~a $5.9 million~~an overall increase in ~~sold-through units of Xtampza, as well as a $1.3~~sales volume.

Intangible asset amortization was $16.8 million increase as a result of changing to the sell-in method in the 2017 Quarter. In addition, a $4.4 million increase to revenues was recorded in the 2017 Quarter to recognize revenue from shipments from prior periods as a result of changing to the sell-in method in the 2017 Quarter.

~~Cost of product revenues were $553,000~~ for the ~~2017~~2021 Quarter, compared to ~~$29,000~~$16.8 million for the ~~2016~~2020 Quarter. ~~The $524,000 increase was primarily related to increased sales in the 2017 Quarter.~~

Research and development expenses were $1.5 million for the 2021 Quarter, compared to $2.1 million for the ~~2017 Quarter, compared to $3.3 million for the 2016~~2020 Quarter. The ~~$1.2 million~~$600,000 decrease was primarily ~~related to:~~due to a decrease in salaries, wages and benefits, including stock-based compensation expense.



~~a decrease in clinical trial costs of $604,000 due to the completion of certain clinical trials in 2016; and~~

~~a decrease in regulatory costs of $498,000 following the FDA approval and launch of Xtampza in 2016.~~

Selling, general and administrative expenses were ~~$22.8~~$30.5 million for the ~~2017~~2021 Quarter, compared to ~~$23.6~~$26.4 million for the ~~2016~~2020 Quarter. The ~~$0.8~~$4.1 million ~~decrease~~increase was primarily related to:

●

~~a decrease in Post Marketing Requirement (“PMR”) costs required with FDA approval of Xtampza of $4.4 million primarily due to higher one-time costs incurred upon the launch of Xtampza; offset by~~

an increase in salaries, wages and benefits, including stock-based compensation expense, of ~~$2.5 million primarily due to an increase from 201 to 235 employees, including~~ $1.6 million;

●

an increase in ~~incentive compensation~~audit, legal and ~~stock-based compensation expense;~~

professional fees of $1.0 million;

●

an increase in ~~legal fees~~travel, trainings, conferences, and meetings of ~~$567,000 primarily due to costs related to litigation; and~~

$429,000;

●

an increase in ~~sales training costs~~product taxes and fees of ~~$422,000 primarily due to the ongoing training of our sales force.~~

$415,000; and

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●

an increase in fees and permits, including fees associated with our participation in the opioid PMR consortium, of $337,000.

Interest expense was $5.1 million for the 2021 Quarter, compared to $8.1 million in the 2020 Quarter. The $3.0 million decrease was primarily due to lower non-cash interest expense associated with the Company’s senior convertible notes in the 2021 Quarter as a result of the adoption of ASU 2020-06 in Q1 2021 combined with lower cash interest expense associated with the Company’s term note due to continued principal repayments.

Interest income was ~~$167,000~~$3,000 for the ~~2017~~2021 Quarter, compared to ~~$2,000 of interest expense~~$3,000 in the 2020 Quarter.

Provision for income taxes was $1.0 million for the ~~2016~~2021 Quarter, compared to $280,000 in the 2020 Quarter. The $720,000 increase ~~in interest income (expense) is~~was primarily due to ~~higher interest rates on money market funds, as well as a decrease in interest expense from our term loan payable as~~ the ~~loan approaches maturity.~~Company’s expected state tax provision, net of discrete tax effects related to excess tax benefits.

Comparison of the nine months ended September 30, ~~2017~~2021 and September 30, ~~2016~~2020

Product revenues, net were ~~$17.7~~$249.5 million for the nine months ended September 30, ~~2017, or the 2017 Period,~~2021 (the “2021 Period”), compared to ~~$408,000~~$233.7 million for the nine months ended September 30, ~~2016, or~~2020 (the “2020 Period”). The $15.8 million increase was related to an increase in revenue for the ~~2016~~Nucynta Products of $14.6 million combined with an increase in revenue for Xtampza ER of $1.2 million. For the 2021 Period, Nucynta IR and ER product revenues, net were $88.9 million and $62.2 million, respectively, compared to $87.0 million and $49.5 million, respectively, for the 2020 Period. The ~~$17.3~~increase in revenue for the Nucynta Products was primarily related to a benefit from lower gross-to-net adjustments and an increase in gross price, partially offset by lower sales volume. For the 2021 Period, Xtampza ER product revenues, net were $98.4 million, compared to $97.2 million for the 2020 Period. The increase in revenue for Xtampza ER was primarily related to an increase in ~~sold-through units of Xtampza, as well as an increase in revenues as a result of changing to the sell-in method in the third quarter of 2017 as discussed in the section above.~~ sales volume and gross price, partially offset by higher gross-to-net adjustments.

Cost of product revenues ~~were $1.5~~(excluding intangible asset amortization) was $47.2 million for the ~~2017~~2021 Period, compared to ~~$29,000~~$54.3 million for the ~~2016~~2020 Period. The ~~$1.5~~$7.1 million decrease was primarily related to a decrease in royalty expense for the Nucynta Products, partially offset by an increase in sales volume for Xtampza. In the 2020 Period, we recognized $14.2 million in sales-based royalty expense due to Assertio under the terms of the Nucynta Commercialization Agreement. Our sales-based royalty obligations to Assertio ceased upon closing of the Nucynta Acquisition on February 13, 2020.

Intangible asset amortization was $50.4 million for the 2021 Period, compared to $43.9 million for the 2020 Period. The $6.5 million increase was primarily related to ~~increased sales~~the Nucynta Acquisition, in which $367.1 million of consideration was allocated to the ~~2017 Period.~~existing intangible asset as incremental cost in 2020. The intangible asset is being amortized on a straight-line basis over its estimated useful life of approximately six years.

Research and development expenses were ~~$6.4~~$7.8 million for the ~~2017~~2021 Period, compared to ~~$11.6~~$7.3 million for the ~~2016~~2020 Period. The ~~$5.2 million decrease~~$500,000 increase was primarily due to an increase in research related ~~to:~~trial costs in connection with the Nucynta ER manufacturing transition, partially offset by a decrease in salaries, wages and benefits, including stock-based compensation expense.



~~a decrease in clinical trial costs of $3.8 million due to the completion of certain clinical trials in 2016;~~

a decrease in Xtampza manufacturing costs associated of $1.3 million reflecting that, prior to April 2016, the Company expensed manufacturing costs associated with Xtampza as research and development expense;

~~a decrease in consulting costs of $840,000 due to lower consulting costs incurred following the launch of Xtampza in June 2016; offset by~~

~~an increase in non-clinical trial costs of $506,000 required with FDA approval of Xtampza; and~~

~~an increase in product candidate manufacturing costs of $336,000~~ ~~for clinical trials~~.

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Selling, general and administrative expenses were ~~$67.7~~$92.4 million for the ~~2017~~2021 Period, compared to ~~$55.3~~$87.0 million for the ~~2016~~2020 Period. The ~~$12.4~~$5.4 million increase was primarily related to:

●

an increase in salaries, wages and benefits, including stock-based compensation expense, of ~~$13.8~~$4.2 million;

●

an increase in audit, legal and professional fees of $3.0 million; and

●

an increase in insurance costs of $602,000, primarily due to higher premiums; partially offset by

●

a decrease in sales, marketing, and consulting costs of $2.5 million, primarily due to ~~an increase from 201 to 235 employees, including an increase in incentive compensation and stock-based compensation expense;~~

~~an increase in legal fees of $2.0 million primarily due to costs related to litigation; offset by~~

~~a decrease in PMR costs required with FDA approval of Xtampza of $3.8 million primarily due to higher one-time~~lower costs incurred ~~upon~~in the ~~launch~~2021 Period to support the ongoing commercialization of ~~Xtampza.~~

our products.

Interest expense was $16.3 million for the 2021 Period, compared to $21.1 million in the 2020 Period. The $4.8 million decrease was primarily due to lower non-cash interest expense associated with the Company’s convertible notes in the 2021 Period as a result of the adoption of ASU 2020-06 in the 2021 Period combined with lower cash interest expense associated with the Company’s term note due to continued principal repayments.

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Interest income was ~~$402,000~~$9,000 for the ~~2017~~2021 Period, compared to ~~$113,000 of interest expense for~~$229,000 in the ~~2016~~2020 Period. The ~~increase in interest income (expense) is~~$220,000 decrease was primarily due to ~~higher~~lower interest rates in the 2021 Period.

Benefit from income taxes was $61.0 million for the 2021 Period, which includes a $63.0 million discrete tax benefit related to the release of the Company’s tax valuation allowance on ~~money market funds, as well as~~the majority of its net operating losses and other deferred tax assets, compared to a ~~decrease~~provision for income taxes of $526,000 for the 2020 Period. The $61.5 increase was primarily due to the Company’s valuation allowance release in ~~interest expense from our term loan payable as~~ the ~~loan approaches maturity.~~2021 Period.

The discrete tax benefit related to the release of the valuation allowance had a significant impact on earnings per share, increasing basic earnings per share by $1.79 and diluted earnings per share by $1.53 in the 2021 Period.

LIQUIDITY AND CAPITAL RESOURCES

Sources of Liquidity

We have incurred cumulative net losses and negative cash flows from operations since ~~inception. Since~~ inception until 2020. Historically, we have funded our operations primarily through the private placements of our preferred stock and convertible notes, public offerings of common stock and convertible notes, and commercial bank debt. As of December 31, 2020, we had $174.1 million in cash and cash equivalents. As of September 30, ~~2017,~~2021, we had ~~$107.6~~$193.2 million in cash and cash equivalents.

~~In January 2016, we issued~~Borrowing Arrangements and ~~sold~~Equity Offerings

There were no material changes in ~~a public offering an aggregate of 2,750,000 shares~~borrowing arrangements and equity offerings since the filing of our common stock at $20.00 per share. We received net proceeds from this public offering of approximately $51.2 million, after deduction of underwriting discounts and commissions and expenses payable by us.most recent Annual Report.

In October 2016, we issued and sold in a public offering an aggregate of 5,750,000 shares of our common stock at $16.00 per share, including 750,000 shares of common stock upon the exercise by the underwriters of their option to purchase additional shares at the public offering price. We received net proceeds from this public offering of approximately $86.2 million, after deduction of underwriting discounts and commissions and estimated expenses payable by us.

In March 2017, we commenced an “at-the-market” offering of our common stock and entered into a Controlled Equity Offering Sales Agreement (the “ATM Sales Agreement”) with Cantor Fitzgerald, as agent, pursuant to which we may issue and sell, from time to time, shares of our common stock having an aggregate offering price of up to $60.0 million. As of September 30, 2017, we had sold an aggregate of 1,148,466 shares of common stock under the ATM Sales Agreement at an average gross sales price of $10.42 per share generating net proceeds of $11.5 million, after deduction of underwriting discounts and commissions and expenses payable by us, all of which were sold during the three months ended September 30, 2017. In October 2017, the Company sold an additional 1,793,290 ATM Shares under the ATM Sales Agreement at an average gross sales price of $11.29 per share generating net proceeds of $19.6 million, after deduction of underwriting discounts and commissions and expenses payable by the Company. The proceeds from the sales during the three months ended September 30, 2017 and October 2017 were used to fund the continued commercialization of Xtampza, research and development efforts of our other product candidates, working capital and other general corporate purposes.

Although it is difficult to predict future liquidity requirements, we believe that our existing cash and cash equivalents, as well as proceeds from our ATM offering through October 2017, will be sufficient to fund our operations into mid-2019. We have based this estimate on assumptions that may prove to be incorrect and we could use our available capital resources sooner than we currently expect. We may never become profitable, or if we do, we may not be able to sustain profitability on a recurring basis.

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Cash Flows

Nine Months Ended September 30,

2017

2016
Net cash used in operating activities
$
(53,722)

$
(51,766)
Net cash used in investing activities

(818)

(2,636)
Net cash provided by financing activities

8,926

49,733


	Nine months ended September 30,
	2021		2020
Net cash provided by operating activities	$	67,359	$	71,365
Net cash used in investing activities		(1,429)		(372,291)
Net cash (used in) provided by financing activities		(46,805)		298,877
Net increase (decrease) in cash, cash equivalents and restricted cash	$	19,125	$	(2,049)

Operating activities. Cash ~~used in~~provided by operating activities was ~~$53.7~~$67.4 million in the ~~2017~~2021 Period, compared to ~~$51.8~~$71.4 million in ~~the 2016~~2020 Period. The ~~increase~~$4.0 million decrease in cash ~~used in~~provided by operating activities was primarily due to changes in ~~the~~ working capital, ~~accounts~~ partially offset by ~~the change in~~higher net loss. We expect cash used in operating activities to increase for the foreseeable future as we continue to commercialize Xtampza and fund research, development and clinical activities for additional product candidates.income exclusive of non-cash items.

Investing activities. Cash used in investing activities was ~~$818,000~~$1.4 million in the ~~2017~~2021 Period, compared to ~~$2.6~~cash used in investing activities of $372.3 million in the ~~2016~~2020 Period. The $370.9 million decrease in cash used in investing activities was primarily ~~due~~related to ~~a one-time upfront fee paid to BDSI~~the Nucynta Acquisition, which closed in the ~~2016~~2020 Period. The remaining change is primarily related to the timing of purchases of property and equipment.

Financing activities.Cash ~~provided by~~used in financing activities was ~~$8.9~~$46.8 million for the ~~2017~~2021 Period, compared to cash provided by financing activities of ~~$49.7~~$298.9 million in the ~~2016~~2020 Period. The $345.7 million decrease in cash provided by financing activities was primarily ~~due~~related to ~~a decrease in~~ net proceeds from the term notes of $192.1 million and issuance of ~~common stock from public offerings,~~the convertible notes of $138.3 million, both of which ~~was $9.4~~were issued in the 2020 Period, combined with repurchases of Common Stock of $15.5 million in the ~~2017 Period and $51.6 million~~2021 Period. The remaining change is primarily related to changes in the ~~2016 Period. The $8.9 million~~repayment of ~~cash provided by financing activities for the 2017 Period primarily reflects net proceeds from the issuance of common stock from public offerings,~~term notes, proceeds from the issuance of shares under our employee stock purchase plan and proceeds from exercises of stock options, offset by ~~repayments of term note and~~ payments made for employee restricted stock tax withholdings. ~~Cash provided by financing activities~~

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Funding Requirements

We believe that our cash and cash equivalents at September 30, 2021 together with expected cash inflows from the commercialization of our products, will enable us to fund our operating expenses, debt service and capital expenditure requirements under our current business plan for the ~~2016 Period primarily reflects net proceeds from the issuance of common stock from public offerings offset by repayments of term note.~~

~~Funding Requirements~~

~~Since 2011,~~foreseeable future. However, we have generated limited revenue from product sales and we continue to incur significant research, development and other expenses related to our ongoing operations. We are in the early stages of commercialization of Xtampza. We anticipate that we will continue to incur losses in the near future as we commercialize Xtampza and continue the development of, and seek regulatory approvals for, other product candidates. We are subject to all of the risks common to the commercialization and development of new pharmaceutical products, and we may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. ~~We will also incur~~

Certain economic or strategic considerations may cause us to seek additional ~~costs associated with operating as a commercial stage~~cash through private or public ~~company. We anticipate that we will need substantial additional funding in connection with our continuing operations.~~

~~Until we can generate a sufficient amount of revenue from our pharmaceutical products, if ever, we expect to finance future cash needs through public~~debt or ~~private~~ equity ~~or debt~~ offerings. ~~Additional capital~~Such funds may not be available when needed, or, we may not be able to obtain funding on ~~reasonable~~favorable terms, ifor at all. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to significantly delay, scale back or discontinue the development or commercialization of one or more of our ~~product candidates.~~products. If we raise additional funds through the issuance of additional debt or equity securities, it could result in dilution to our existing shareholders, increased fixed payment obligations and the existence of securities with rights that may be senior to those of our common stock. If we incur indebtedness, we could become subject to covenants that would restrict our operations and potentially impair our competitiveness, 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 that could adversely impact our ability to conduct our business. Any of these events could significantly harm our business, financial condition and prospects.

Our forecast ~~of the period of time through which~~that our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. The amount and timing of future funding requirements, both near- and long-term, will depend on many factors, including:

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●

~~the cost of establishing sales, marketing and distribution capabilities for Xtampza and any other products for which we may receive regulatory approval;~~

the generation of reasonable levels of revenue from ~~the sale of Xtampza;~~

products sales;

●

the ~~design, initiation, progress, size, timing, costs~~cost of growing and ~~results of preclinical studies~~maintaining sales, marketing and ~~clinical trials~~distribution capabilities for our ~~product candidates;~~

products;

●

the ~~outcome, timing and~~ cost of ~~regulatory approvals by the FDA and comparable foreign regulatory authorities, including the potential for the FDA or comparable foreign regulatory authorities~~patent infringement litigation, which may be expensive to ~~require that we perform more studies than, or evaluate clinical endpoints other than those that we currently expect;~~

defend;

●

the cost of litigation related to opioid marketing and distribution practices;

●

the timing and costs associated with manufacturing ~~Xtampza and~~ our ~~product candidates for preclinical studies, clinical trials and, if approved,~~products, for commercial ~~sale;~~

sale and clinical trials; and

●

~~the number and characteristics of product candidates that we pursue;~~

the cost of patent infringement litigation, including our litigation with Purdue Pharma, L.P., or Purdue, relating to Xtampza or our product candidates, which may be expensive to defend and delay the commercialization of our product candidates;

~~our need to expand our research and development activities, including our need and ability to hire additional employees;~~

~~our need to implement additional infrastructure and internal systems and hire additional employees to operate as a public company;~~

~~our need to expand our regulatory and compliance functions; and~~

the effect of competing technological and market developments.

If we cannot ~~expand our operations or otherwise~~ capitalize on our business opportunities because we lack sufficient capital, our business, financial condition and results of operations could be materially adversely affected.

ADDITIONAL INFORMATION

To supplement our financial results presented on a GAAP basis, we have included information about certain non-GAAP financial measures such as adjusted EBITDA and operating expenses, excluding stock-based compensation. We use these non-GAAP financial measures to understand, manage and evaluate our business as we believe they provide additional information on the performance of our business. We believe that the presentation of these non-GAAP financial measures, taken in conjunction with our results under GAPP, provide analysts, investors, lenders and other third parties insight into our view and assessment of our ongoing operating performance. In addition, we believe that the presentation of these non-GAAP financial measures, when viewed with our results under GAAP and the accompanying reconciliations, provide supplementary information that may be useful to analysts, investors, lenders, and other third parties in assessing our performance and results from period to period. We report these non-GAAP financial measures to portray the results of our operations prior to considering certain income statement elements. These non-GAAP financial measures should be considered in addition to, and not as a substitute for, or superior to, net income or other financial measures calculated in accordance with GAAP.

In our quarterly and annual reports, earnings press releases and conference calls, we may discuss the following financial measures that are not calculated in accordance with GAAP, to supplement our consolidated financial statements presented on a GAAP basis.

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Adjusted EBITDA

Adjusted EBITDA is a non-GAAP financial measure that represents GAAP net income adjusted to exclude interest expense, interest income, the benefit from or provision for income taxes, depreciation, amortization, and stock-based compensation. Adjusted EBITDA, as used by us, may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.

There are several limitations related to the use of adjusted EBITDA rather than net income, which is the nearest GAAP equivalent, such as:

●

adjusted EBITDA excludes depreciation and amortization, and, although these are non-cash expenses, the assets being depreciated or amortized may have to be replaced in the future, the cash requirements for which are not reflected in adjusted EBITDA;

●

we exclude stock-based compensation expense from adjusted EBITDA although (a) it has been, and will continue to be for the foreseeable future, a significant recurring expense for our business and an important part of our compensation strategy and (b) if we did not pay out a portion of our compensation in the form of stock-based compensation, the cash salary expense included in operating expenses would be higher, which would affect our cash position;

●

adjusted EBITDA does not reflect changes in, or cash requirements for, working capital needs;

●

adjusted EBITDA does not reflect the benefit from or provision for income taxes or the cash requirements to pay taxes; and

●

adjusted EBITDA does not reflect historical cash expenditures or future requirements for capital expenditures or contractual commitments.

Adjusted EBITDA for the three and nine months ended September 30, 2021 and 2020 was as follows:


	Three months ended				Nine months ended
	September 30,				September 30,
	2021		2020		2021		2020
GAAP net income	$	8,046	$	11,286	$	96,551	$	19,794
Adjustments:
Interest expense		5,115		8,063		16,257		21,145
Interest income		(3)		(3)		(9)		(229)
Provision for (benefit from) income taxes		991		280		(61,049)		526
Depreciation		448		195		1,312		589
Amortization		16,796		16,795		50,386		43,885
Stock-based compensation expense		5,948		5,165		19,343		15,700
Total adjustments	$	29,295	$	30,495	$	26,240	$	81,616
Adjusted EBITDA	$	37,341	$	41,781	$	122,791	$	101,410

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Adjusted EBITDA was $37.3 million for the 2021 Quarter compared to $41.8 million for the 2020 Quarter. The $4.5 million decrease was primarily due to lower GAAP net income of $3.2 million and a lower adjustment for interest expense of $2.9 million, partially offset by higher adjustments for provision for income taxes and stock-based compensation expense of $711,000 and $783,000, respectively.

Adjusted EBITDA was $122.8 million for the 2021 Period compared to $101.4 million for the 2020 Period. The $21.4 million increase was primarily due to higher GAAP net income of $76.8 million and higher adjustments for amortization expense of $6.5 million and stock-based compensation expense of $3.6 million, partially offset by lower adjustments for income taxes of $61.6 million, primarily due to the impact of the Company’s valuation allowance release, and interest expense of $4.9 million.

The following is a summary of 2021 quarterly Adjusted EBITDA as of September 30, 2021:


	First Quarter		Second Quarter		Third Quarter
	2021		2021		2021
GAAP net income	$	15,662	$	72,843	$	8,046
Adjustments:
Interest expense		5,721		5,421		5,115
Interest income		(3)		(3)		(3)
Provision for (benefit from) income taxes		(188)		(61,852)		991
Depreciation		439		425		448
Amortization		16,795		16,795		16,796
Stock-based compensation expense		6,879		6,516		5,948
Total adjustments	$	29,643	$	(32,698)	$	29,295
Adjusted EBITDA	$	45,305	$	40,145	$	37,341

Operating Expenses, Excluding Stock-Based Compensation

Operating expenses, excluding stock-based compensation is a non-GAAP financial measure that represents GAAP operating expenses adjusted to exclude stock-based compensation expense.

Operating expenses, excluding stock-based compensation for the three and nine months ended September 30, 2021 and 2020 were as follows:


	Three months ended				Nine months ended
	September 30,				September 30,
		2021		2020		2021		2020
GAAP Operating expenses	$	31,964		28,567		100,200		94,308
Stock-based compensation		5,948		5,165		19,343		15,700
Operating expenses, excluding stock-based compensation	$	26,016	$	23,402	$	80,857	$	78,608

Operating expenses, excluding stock-based compensation was $26.0 million in the 2021 Quarter compared to $23.4 million in the 2020 Quarter. The $2.6 million increase was primarily related to the increase in selling, general and administrative expenses, partially offset by the decrease in research and development expenses, both described above in “Results of Operations.”

Operating expenses, excluding stock-based compensation was $80.9 million in the 2021 Period compared to $78.6 million in the 2020 Period. The $2.3 million increase was primarily related to the increase in selling, general and administrative expenses, combined with the increase in research and development expenses, both described above in “Results of Operations.”

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The following is a summary of 2021 quarterly Operating expenses, excluding stock-based compensation through September 30, 2021:


		First Quarter		Second Quarter		Third Quarter
		2021		2021		2021
GAAP Operating expenses	$	34,406	$	33,830	$	31,964
Stock-based compensation		6,879		6,516		5,948
Operating expenses, excluding stock-based compensation	$	27,527	$	27,314	$	26,016

The following is a summary of 2020 quarterly Operating expenses, excluding stock-based compensation for the year ended December 31, 2020.


		First Quarter		Second Quarter		Third Quarter		Fourth Quarter
		2020		2020		2020		2020
GAAP Operating expenses	$	33,926	$	31,815	$	28,567	$	29,296
Stock-based compensation		4,951		5,584		5,165		6,210
Operating expenses, excluding stock-based compensation	$	28,975	$	26,231	$	23,402	$	23,086

CONTRACTUAL OBLIGATIONS

There have been no material changes to the contractual obligations and commitments described under Management’s Discussion and Analysis of Financial Condition and Results of Operations in our most recent Annual Report.

OFF-BALANCE SHEET ARRANGEMENTS

We did not have during the periods presented ~~and we do not currently have,~~ any ~~off-balance~~off‑balance sheet arrangements, as defined under SEC rules.

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

~~We are exposed~~For information regarding our exposure to certain market risks, see Item 7A, Quantitative and Qualitative Disclosures About Market Risk, in our Annual Report. There have been no significant changes in our financial instrument portfolio or market risk related to changes in interest rates. As of September 30, 2017, we had cash and cash equivalents consisting of cash and money market funds of $107.6 million. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates, particularly becauseexposures since our money market funds are short-term highly liquid investments. Due to the short-term duration and the low risk profile of our investments, an immediate 10% change in interest rates would not have a material effect on the fair market value of our portfolio.fiscal year ended December 31, 2020.

Item 4. Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of September 30, ~~2017.~~2021. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed,

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summarized and reported, within the time periods specified in the SEC’s rules and forms. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of September 30, ~~2017,~~2021, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

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Changes in Internal Control Over Financial Reporting

NoThere has been no change in our internal control over financial reporting ~~occurred~~(as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the fiscal quarter ~~ended September 30, 2017~~covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

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PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

~~There~~Except as set forth in Note 14 to our financial statements, which is incorporated herein by reference to the extent applicable, there are no other material changes from the legal proceedings previously disclosed in our Annual ~~Report on Form 10-K for the period ended December 31, 2016 filed with the SEC on March 10, 2017.~~Report.

Item 1A. Risk Factors.

Investing in our common stock involves a high degree of risk. ~~You~~Investors should carefully consider the risks described below, as well as all other information included in this Quarterly Report on Form 10-Q, including our financial statements, the notes thereto and the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” If any of the following risks actually occurs, our business, financial condition, operating results, prospects and ability to accomplish our strategic objectives could be materially harmed. As a result, the trading price of our common stock could decline and ~~you~~investors could lose all or part of ~~your~~their investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair our business operations and the market price of our common stock.

Risks Related to Our Financial Position and Capital Needs

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

~~We are an early commercial-stage pharmaceutical company. To date, we have focused on developing our first product, Xtampza. Investment in pharmaceutical product development~~maintain profitability is highly speculative because it entails substantial upfront capital expenditures and significant risk that a product candidate will fail to gain regulatory approval or become commercially viable. Since 2010, we have only generated limited revenue from product sales, and we continue to incur significant research, development, commercialization and other expenses related to our ongoing operations. As a result, we are not profitable and have incurred losses in each period since January 1, 2011. For the year ended December 31, 2016, we reported a net loss of $94.2 million, and we had an accumulated deficit of $223.2 million at December 31, 2016. For the nine months ended September 30, 2017, we reported a net loss of $57.5 million, and we had an accumulated deficit of $280.6 million at September 30, 2017.

We expect to continue to incur losses for the foreseeable future as we continue to commercialize Xtampza and continue our development of, and seek regulatory approvals for, our product candidates. We may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect our business. The size of our future net losses will depend, in part, ondependent upon our ability to ~~generate revenues~~continue successfully commercializing our products and ~~on the rate of future growth of our expenses. If~~ any ~~of our~~products and product candidates ~~fail in clinical trials or does not gain final regulatory approval, or if approved, fails to achieve market acceptance,~~that we may ~~never become profitable. Even if we achieve profitability~~develop or acquire in the ~~future, we may not be able~~future. Our failure to ~~sustain profitability in subsequent periods. Our prior losses~~do so successfully could impair our growth strategy and ~~expected future losses~~plans and could have ~~had and will continue to have an~~a material adverse effect on our ~~shareholders’ equity~~business, financial position, and ~~working capital.~~operating results.

~~We currently generate limited revenue from the sale of products and may never become profitable.~~

~~We began the commercial sale of our first product, Xtampza, in June 2016 and have only generated limited revenue from product sales.~~ Our ability to ~~generate additional revenue and become profitable~~maintain profitability depends upon our ability to ~~successfully~~realize the full commercial potential of our products and to commercialize ~~Xtampza, our existing product candidates, and~~successfully any other products and product candidates that we may develop, in-license or acquire in the future. ~~Even if we are able to successfully achieve regulatory approval for these product candidates, we do not know when any of these product candidates will generate revenue for us, if at all.~~ Our ability to generate revenue from our current or future ~~product candidates~~products depends on a number of factors, including ourability to:

●

~~successfully commercialize Xtampza;~~

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successfully satisfy FDA post-marketing requirements for Xtampza, including studies and clinical trials that have been required for other extended release/long acting opioid analgesics and individual studies and clinical trials of Xtampza;

~~set~~realize a commercially viable price for our products;

●

manufacture commercial quantities of our products at acceptable cost levels;

●

~~develop~~sustain a commercial organization capable of sales, marketing and distribution for the products we ~~intend to sell ourselves in the markets in which we have retained commercialization rights;~~

sell;

●

~~find suitable distribution collaborators to help us market, sell and distribute our products, if approved, in markets outside the United States;~~

obtain coverage and adequate reimbursement from third parties, including government payors;

and

●

~~successfully complete development activities,~~comply with existing and changing laws and regulations that apply to the pharmaceutical industry, including ~~the necessary clinical trials, with respect~~opioid manufacturers, and to our ~~product candidates;~~

products specifically, including FDA post-marketing requirements.

~~complete and submit regulatory submissions to the FDA and obtain regulatory approval; and~~

~~complete and submit applications to, and obtain regulatory approval from, foreign regulatory authorities, if we choose to commercialize our product candidates outside the United States.~~

In addition, because of the numerous risks and uncertainties associated with product development, including that our product candidates may not advance through development or achieve the safety and efficacy (including the efficacy of our abuse-deterrent technology) endpoints of applicable clinical trials, 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. Furthermore, we anticipate incurring significant costs associated with commercializing these products.

~~Even if we are able to generate revenues from the sale of our products, we may not become profitable and may need to obtain additional funding to continue operations.~~ If we fail to ~~become profitable or are unable to sustain~~maintain profitability on a continuing basis, then we may be unable to continue our operations at planned levels and be forced to reduce our operations.

~~If we require additional capital to fund our operations and we fail to obtain necessary financing, we may be unable to complete the development and commercialization of our product candidates.~~

Our operations have consumed substantial amounts of cash. We expect to continue to spend substantial amounts to advance the development of our product candidates and to commercialize Xtampza and any product candidates for which we may receive regulatory approval. We believe that our existing cash and cash equivalents and expected revenue contributions from Xtampza, as well as proceeds from our ATM offering through October 2017, will be sufficient to fund our operations into mid-2019, including the commercialization of Xtampza, and the continuation of our development of our product candidates. However, we may require additional capital for the further commercialization of Xtampza and our product candidates and may also need to raise additional funds sooner in order to continue development of our product candidates.

We cannot be certain that additional funding will be available on acceptable terms, or at all. If we are unable to raise additional capital in sufficient amounts, when required or on acceptable terms, we also could be required to:

~~significantly delay, scale back or discontinue the development or the commercialization of Xtampza, our product candidates or one or more of our other research and development initiatives;~~

~~seek collaborators for Xtampza and/or one or more of our product candidates at an earlier stage than otherwise would be desirable or on terms that are less favorable than might otherwise be available;~~

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

~~significantly curtail operations.~~

Our forecast of the period of time through which our financial resources will be adequate to support our operations is a forward-looking statement and involves risks and uncertainties, and actual results could vary as a result of a number of factors, including the factors discussed elsewhere in this “Risk Factors” section. We have based this estimate on assumptions that may prove to be wrong, and we could utilize our available capital resources sooner than we currently expect. Our future funding requirements, both near and long-term, will depend on many factors, including, but not limited to:

~~our ability to obtain and maintain abuse-deterrent claims in the product labels for our products and product candidates;~~

our ability to successfully satisfy the FDA post-marketing requirements of Xtampza, including studies and clinical trials that have been required for other extended release/long acting opioid analgesics and individual studies and clinical trials of Xtampza;

~~clinical development plans for our product candidates;~~

the outcome, timing and cost of the regulatory approval process by the FDA and foreign regulatory authorities, including the potential for regulatory authorities to require that we perform more studies than those that we currently expect;

~~the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights, including defending Purdue’s remaining patent infringement claims against us;~~

~~the cost and timing of completion of existing or expanded commercial-scale outsourced manufacturing activities;~~

the cost of maintaining, and if appropriate, expanding, sales, marketing and distribution capabilities for Xtampza and any product candidates for which we may receive regulatory approval in regions where we choose to commercialize our products; and

~~the initiation, progress, timing, costs and results of clinical trials for our product candidates and any future product candidates we may in-license.~~

~~Raising additional capital may cause dilution to our existing shareholders, restrict our operations or require us to relinquish rights to Xtampza, our technologies or product candidates.~~

We may seek additional capital through a combination of private and public equity offerings, debt financings, receivables or royalty financings, strategic collaborations and alliances and licensing arrangements. To the extent that we raise additional capital through the sale of equity or convertible debt securities, existing shareholders’ ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of existing shareholders. Debt, receivables and royalty financings may be coupled with an equity component, such as warrants to purchase stock, which could also result in dilution of our existing shareholders’ ownership. The incurrence of additional indebtedness could result in increased fixed payment obligations and could also result in certain restrictive covenants, such as limitations on our ability to incur further debt, limitations on our ability to acquire or license intellectual property rights and other operating restrictions that could have a material adverse effect on our ability to conduct our business and may result in liens being placed on our assets and intellectual property. If we were to default on any of our indebtedness, we could lose such assets and intellectual property. If we raise additional funds through strategic collaborations and alliances and licensing arrangements with third parties, we may have to relinquish valuable rights to Xtampza or our product candidates, or grant licenses on terms that are not favorable to us. If we are unable to raise additional funds

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through equity or debt financing when needed, we may be required to delay, limit, reduce or terminate our product development or commercialization efforts or grant rights to develop and market our technologies that we would otherwise prefer to develop and market ourselves.

~~We have a limited operating history, which may make it difficult for you to evaluate the success of our business to date and to assess our future viability.~~

Our predecessor was originally incorporated in Delaware in April 2002 under the name Collegium Pharmaceuticals, Inc. In October 2003, our predecessor changed its name to Collegium Pharmaceutical, Inc. In July 2014, we reincorporated in the Commonwealth of Virginia pursuant to a merger whereby Collegium Pharmaceutical, Inc., a Delaware corporation, merged with and into Collegium Pharmaceutical, Inc., a Virginia corporation, with the Virginia corporation surviving the merger. From 2002 until 2010, our operations focused primarily on marketing proprietary therapies to the wound care and dermatology industry through our former subsidiary, Onset Therapeutics, LLC, which was spun off and became a part of PreCision Dermatology, Inc. in 2010. Since 2010, our operations have focused primarily on developing the DETERx technology platform and identifying and developing product candidates that utilize the DETERx technology, including our first product, Xtampza. We are currently in the early stages of the commercial launch of Xtampza and, therefore, we have not yet demonstrated an ability to commercialize a product successfully. Consequently, any predictions about our future success, performance or viability may not be as accurate as they could be if we had a longer operating history.

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

As of December 31, ~~2016,~~2020, we had a federal net operating loss ~~or NOL,~~(“NOL”) carryforward of approximately ~~$190.9~~$226.8 million and state ~~net operating loss~~NOL carryovers of approximately ~~$145.9~~$170.3 million, which are available to offset future taxable income. The U.S. federal NOL carryforwards begin to expire in 2028, and the state NOL carryforwards begin to expire in 2030. We also had U.S. federal tax credits of approximately ~~$3.4~~$4.6 million, and state tax credits of approximately ~~$522,000, these~~$1.2 million. These tax attributes are ~~prior~~generally subject to ~~consideration of~~a limited carryover/carryback period and are also subject to the annual limitations that may be imposed under Section 382 of the Internal Revenue Code of 1986, as amended. During the three months ended June 30, 2021, the Company released the portion of the valuation allowance on deferred tax assets expected to be realized through future earnings. Refer to Note 15, Income Taxes, for more information.

We have outstanding indebtedness in the form of our 2.625% Convertible Senior Notes and our Loan Agreement with BioPharma, which may adversely affect our business, financial condition and results of operations.

In February 2020, in connection with the Nucynta Acquisition, we incurred (i) $143.8 million in principal amount of indebtedness in the form of 2.625% Convertible Senior Notes due in 2026 (the “Convertible Notes”) and (ii) $200.0 million in secured indebtedness pursuant to our Loan Agreement with BioPharma Credit PLC, as collateral agent and lender, and BioPharma Credit Investments V (Master) LP, as lender (as amended ~~or Section 382. These carryforwards begin~~from time to ~~expire in 2022. Under Section 382, 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,~~time, the ~~corporation’s ability to use its pre-change NOLs and other pre-change tax attributes (such as research and development tax credits) to offset its post-change income may be limited.~~“Loan

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Agreement”). We may ~~experience ownership~~also incur additional indebtedness to meet future financing needs. Our existing and future levels of indebtedness could have significant negative consequences for our security holders and our business, results of operations and financial condition by, among other things:

●

requiring the dedication of a substantial portion of our cash flow from operations to service our indebtedness, which will reduce the amount of cash available for operations, working capital, capital expenditures, expansion, acquisitions or general corporate or other purposes;

●

limiting our ability to obtain additional financing;

●

limiting our flexibility to plan for, or react to, changes in our business;

●

diluting the interests of our existing shareholders as a result of issuing shares of our common stock upon conversion of the convertible notes;

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placing us at a possible competitive disadvantage with competitors that are less leveraged than we are or have better access to capital;

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increasing our vulnerability to downturns in our business, our industry or the economy in general, including any such downturn related to the impact of the COVID-19 pandemic.

Holders of our Convertible Notes will have the right to require us to repurchase our Convertible Notes for cash following a fundamental change, or to pay any cash amounts due upon conversion of our Convertible Notes. Further, our noteholders, subject to a limited exception described in the ~~future as~~notes, may require us to repurchase their notes following a ~~result~~fundamental change at a cash repurchase price generally equal to the principal amount of ~~shifts~~the notes to be repurchased, plus accrued and unpaid interest, if any. In addition, upon conversion, we will satisfy part or all of our conversion obligation in cash unless we elect to settle conversions solely in shares of our ~~stock ownership some of which~~common stock. We may not have enough available cash or be able to obtain financing at the time we are ~~outside~~required to repurchase the notes or pay the cash amounts due upon conversion. Applicable law, regulatory authorities and the agreements governing our control. We have not performed any current analyses under Section 382 and cannot forecast or otherwise rely on deriving benefit from our various federal or state tax attribute carryforwards. As a result, if we earn net taxable income,other indebtedness may restrict our ability to ~~use~~repurchase the notes or pay the cash amounts due upon conversion. Additionally, our ~~pre-change NOL carryforwards~~Loan Agreement contains certain covenants and obligations applicable to ~~offset U.S. federal taxable income~~us, including, without limitation, covenants that require us and our subsidiaries to maintain $200 million in annual net sales and covenants that limit our ability to incur additional indebtedness or liens, make acquisitions or other investments or dispose of assets outside the ordinary course of business.

Failure to comply with covenants in the indenture governing the Convertible Notes or in the Loan Agreement would constitute an event of default under these instruments, notwithstanding our ability to meet our debt service obligations. Our failure to repurchase notes or to pay the cash amounts due upon conversion when required will constitute a default under the indenture. A default under the indenture or the fundamental change itself could also lead to a default under agreements governing our other indebtedness, which may result in that other indebtedness becoming immediately payable in full. In such event, we may not have sufficient funds to satisfy all amounts due under our other indebtedness (including the Loan Agreement) and the notes. The Loan Agreement includes various customary remedies for the lenders following an event of default, including the acceleration of repayment of outstanding amounts under the Loan Agreement and execution upon the collateral securing obligations under the Loan Agreement. If we fail to comply with such covenants and terms, we may be in default and the maturity of the related debt could be accelerated and become immediately due and payable. In addition, because our assets are pledged as a security under the Loan Agreement, if we are not able to cure any default or repay outstanding borrowings, our assets are subject to ~~limitations, which~~the risk of foreclosure by our lenders. Moreover, a default on indebtedness under the Loan Agreement could ~~potentially~~ result in ~~increased future tax liability~~a default under the terms of the indenture governing our Convertible Notes. There is no guarantee that we would be able to ~~us. In addition, at the state level, there may be periods during which the use~~satisfy our obligations if any of ~~NOLs~~our indebtedness is ~~suspended or otherwise limited, which could accelerate or permanently increase state taxes owed.~~accelerated.

Risks Related to our Products

If we cannot continue successfully commercializing Xtampza ER or the Nucynta Products, our business, financial condition and ~~Product Candidates~~

~~Our success depends in large part on~~results of operations may be materially adversely affected and the ~~commercial success~~price of our ~~lead product, Xtampza.~~common stock may decline.

To date, we have invested substantial resources in the development of ~~our lead product,~~ Xtampza ER, which has been approved by the FDA. In February 2018, we began marketing the Nucynta Products. Our business and future success are substantially dependent on our ability to continue successfully and timely commercialize this product, which may never occur. We currently generate limited revenues from product sales and we may never be able to commercialize Xtampza, or any product candidates that are approved by the FDA, successfully.commercializing these products.

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Our ability to continue successfully ~~commercialize~~commercializing Xtampza ER and the Nucynta Products will depend on many factors, including but not limited to:

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our ability to successfully satisfy FDA post-marketing requirements, including studies and clinical trials that have been required for other extended release/long acting opioid analgesics and individual studies and clinical trials of Xtampza and its components;

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our ability to manufacture commercial quantities of Xtampza ER at reasonable cost and with sufficient speed to meet commercial demand;

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our ability to ~~continue to build and retain a~~execute sales and marketing ~~organization to market Xtampza;~~

strategies successfully and continually;

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our success in educating physicians, patients and caregivers about the benefits, administration, use and coverage of ~~Xtampza;~~

our products;

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the perceived availability and advantages, relative cost, relative safety and relative efficacy of other abuse-deterrent products and treatments ~~for chronic pain and chronic pain~~ with ~~dysphagia;~~

similar indications;

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our ability to defend successfully ~~defend~~ any challenges to our intellectual property or suits asserting patent infringement relating to ~~Xtampza;~~

our products;

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the availability and quality of coverage and adequate reimbursement for ~~Xtampza; and~~

our products;

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a continued acceptable safety profile of ~~Xtampza following approval.~~

our products; and

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our ability to comply with applicable legal and regulatory requirements, including any additional manufacturing or packaging requirements that may become applicable to certain opioid products.

Many of these matters are beyond our control and are subject to other risks described elsewhere in this “Risk Factors” section. Accordingly, we cannot assure you that we will be able to continue successfully ~~commercialize~~commercializing or to generate sufficient revenue from ~~Xtampza.~~our products. If we cannot do so, or are significantly delayed in doing so, our business will be materially harmed.

Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the product labeling of Xtampza ER and our ability to ~~successfully~~ market Xtampza ER successfully may be adversely affected.

~~It is estimated that~~

Xtampza ER was approved with label language describing abuse-deterrent properties of the ~~U.S. market includes approximately 11 million patients~~formulation with ~~chronic pain~~respect to the nasal and IV routes of abuse, consistent with ~~dysphagia. Our Xtampza microspheres are designed to be removed from the capsule~~Guidance for Industry, “Abuse-Deterrent Opioids- Evaluation and ~~sprinkled on food or into a cup, and then directly into the mouth, or in feeding tubes, without compromising their extended-release properties. On April 26, 2016,~~Labeling.” In November 2017, the FDA ~~granted approval~~approved an sNDA for Xtampza ER to include comparative oral pharmacokinetic data from a clinical study evaluating the effect of physical manipulation by crushing Xtampza ~~NDA, including~~ER compared with OxyContin and a control (oxycodone hydrochloride immediate-release), results from an ~~approved product label.~~ oral human abuse potential study and the addition of an oral abuse deterrent claim.

The FDA ~~could change~~can require changes to the product ~~labeling. If the product label~~labeling for Xtampza ~~is modified in the future so as to exclude the flexible dose administration options,~~ER or the ~~FDA requires us to have a boxed warning similar to competitor product labeling stating that “crushing, dissolving or chewing~~Nucynta Products at any time which can ~~cause rapid release and absorption of a potentially fatal dose of the active drug,” it will limit~~impact our ability to differentiate Xtampza from other abuse-deterrent opioid formulations on the basis of flexible dosing options, and we may not be able to market Xtampza to patients with chronic pain with dysphagia. As a result, this may have an adverse effect on our business and our prospects for future growth.

~~If the FDA does not conclude that our~~generate product ~~candidates in development are sufficiently bioequivalent, or demonstrate comparable bioavailability to their respective listed drugs, or~~sales. In particular, if the FDA ~~otherwise~~determines that our post-marketing data for Xtampza ER does not ~~conclude~~demonstrate that ~~our product candidates satisfy~~ the ~~requirements for the Section 505(b)(2) approval pathway, the approval pathway for those product candidates will likely take significantly longer, cost significantly more and entail significantly~~abuse-deterrent properties result in reduction of abuse, or demonstrates a shift to routes of abuse that present a greater ~~complications and risks than anticipated, and~~risk, the FDA may ~~not approve those~~find that product ~~candidates.~~

~~A key element~~labeling revisions are needed, and potentially require the removal of our strategy is to seek FDA approval for our product candidates through the Section 505(b)(2) regulatory pathway. Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, or FD&C Act, permits the filing of an NDA that contains full safety and efficacy reports but where at least some of the information required for approval comes from studies not conducted by or for the applicant, such as the FDA’s findings of safety and efficacy in the approval of a similar drug, and forabuse-deterrence claims, which ~~the applicant has not obtained a right of reference and/or published literature. Such reliance is typically predicated on a showing of bioequivalence or comparable bioavailability to an approved drug.~~

If the FDA does not allow us to pursue the Section 505(b)(2) approval pathway for our product candidates, or if we cannot demonstrate bioequivalence or comparable bioavailability of our product candidates to approved products, we may need to conduct additional clinical trials, provide additional data and information, and meet additional standards for regulatory approval. If this were to occur, the time and financial resources required to obtain FDA approval for these

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~~product candidates~~ would ~~increase. Moreover, our inability to pursue the Section 505(b)(2) approval pathway could result in new competitive products reaching the market sooner than our product candidates, which could~~ have a material adverse effect on our ~~competitive position and our business prospects. Even if we are allowed~~ability to ~~pursue the Section 505(b)(2) approval pathway, we cannot assure you that our product candidates will receive the requisite approvals for commercialization on a timely basis, if at all.~~

In addition, notwithstanding the approval of a number of products by the FDA under Section 505(b)(2) over the last few years, pharmaceutical companies and others have objected to the FDA’s interpretation of Section 505(b)(2). If the FDA’s interpretation of Section 505(b)(2) iscontinue successfully challenged, the FDA may change its policies and practices with respect to Section 505(b)(2) regulatory approvals, which could delay or even prevent the FDA from approving any NDA that we submit under Section 505(b)(2).

Even if our product candidates are approved under Section 505(b)(2), the approval may be subject to limitations on the indicated uses for which the products may be marketed or to other conditions of approval, or may contain requirements for costly post-marketing testing and surveillance to monitor the safety or efficacy of the products, including additional preclinical studies and clinical trials.

Our decision to seek approval of our product candidates, including Xtampza, under Section 505(b)(2) increases the risk that a patent infringement suit may be filed against us, which would delay the FDA’s final regulatory approval of such product candidates.

In connection with any NDA that we file under Section 505(b)(2), we are required to notify the patent holders of the reference listed drug that we have certified to the FDA that any patents listed for the reference listed drug in the FDA’s Orange Book publication are invalid, unenforceable or will not be infringed by the manufacture, use or sale of our drug. If the patent holder files a patent infringement lawsuit against us within 45 days of its receipt of notice of our certification, the FDA is automatically prevented from approving our Section 505(b)(2) NDA until the earliest of 30 months, expiration of the patents, settlement of the lawsuit or a court decision in the infringement case that is favorable to us. Accordingly, we may invest significant time and expense in the development of our product candidates only to be subject to significant delay and expensive and time-consuming patent litigation before our product candidates may be commercialized.

Even if we are found not to infringe any potential plaintiff’s patent claims or the claims are found invalid or unenforceable, defending any such infringement claim could be expensive and time-consuming, and could delay the launch of our product candidates and distract management from their normal responsibilities. The Court could decline to hear our summary judgment motion, could decline to act expeditiously to issue a decision or hold a trial, or could decline to find that all of the listed patents are invalid or non-infringed. If we are unsuccessful in our defense of non-infringement and unable to prove invalidity of the listed patents, the court could issue an injunction prohibiting the launch of our product candidates. If we were to receive final regulatory approval by the FDA and launch any of our product candidates, prior to a full and final determination that the patents are invalid or non-infringed, we could be subject to substantial liability for damages if we do not ultimately prevail on our defenses to a claim of patent infringement.

The regulatory approval processes of the FDA and foreign regulatory authorities are lengthy, time-consuming and unpredictable, and if we are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed.

The time required to obtain approval by the FDA and foreign regulatory authorities is unpredictable, but typically takes many years following the commencement of preclinical studies and clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval varies among jurisdictions and may change during the course of a product candidate’s clinical development. Although the FDA has approved Xtampza, it is possible that none of our product candidates or any future product candidates that we may in-license, acquire or develop will ever obtain final regulatory approval from the FDA or any foreign regulatory authority. Moreover, even after any product candidate receives final regulatory approval, the FDA may require, as it has for Xtampza, costly post-marketing requirements.

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~~Successful and timely satisfaction of these post-marketing requirements will be necessary for us to maintain regulatory approval.~~

Our product candidates could fail to receive regulatory approval from the FDA or a foreign regulatory authority, or we may be required to conduct more extensive studies and clinical trials in order to receive such approval, for many reasons, including, but not limited to:

~~the FDA and/or foreign regulatory authorities may disagree with or disapprove of the design or implementation of our clinical trials;~~

~~failure to demonstrate that a product candidate is safe and effective for its proposed indication;~~

~~failure to demonstrate that a product candidate is bioequivalent to its listed drug;~~

~~failure of clinical trials to meet criteria required for approval;~~

~~failure to demonstrate that a product candidate’s clinical and other benefits outweigh its safety risks;~~

~~the FDA or foreign regulatory authorities may disagree with our interpretation of data from preclinical studies or clinical trials;~~

~~deficiencies in the manufacturing processes or failure of third-party manufacturing facilities with whom we contract for clinical and commercial supplies to pass inspection;~~

~~the FDA or foreign regulatory authorities may not approve the manufacturing processes or facilities of third party manufacturers with which we contract for clinical and commercial supplies; or~~

insufficient data collected from clinical trials of our product candidates or changes in the approval policies or regulations that render our preclinical and clinical data insufficient to support the submission and filing of an NDA or to obtain regulatory approval.

The lengthy approval process, as well as the unpredictability of future clinical trial results, may result in our failing to obtain regulatory approval to market our product candidates, which would harm our business, results of operations and prospects significantly.

In addition, even if we obtain approval, regulatory authorities may approve any of our product candidates for fewer or more limited indications than we request, may not approve, with respect to certain foreign regulatory authorities, the price we intend to charge for our products, may grant approval contingent on the performance of costly post-marketing requirements, or may approve a product label that does not include the labeling claims necessary or desirable for the successful commercialization of that product. Any of the foregoing scenarios could have a material adverse effect on our business.

The FDA or a foreign regulatory authority may require more information, including additional preclinical or clinical data to support approval, which may delay or prevent approval and our commercialization plans, or cause us to abandon the development program. Even if we obtain regulatory approval, our product candidates may be approved for fewer or more limited indications than we request, such approval may be contingent on the performance of costly post-marketing requirements, or we may not be allowed to include the labeling claims necessary or desirable for the successful commercialization of such product candidate.

In order to market and sell our products outside the United States, we will likely need to obtain separate marketing approvals and comply with numerous and varied regulatory requirements and regimes, which can involve additional testing, may take substantially longer than the FDA approval process, and still generally includes all of the risks associated with obtaining FDA approval. In addition, in many countries outside the United States, it is required that the

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product be approved for reimbursement before the product can be approved for sale in that country. FDA approval does not ensure approval by regulatory authorities in other countries or jurisdictions, and approval by one regulatory authority outside the United States does not ensure approval by the FDA or regulatory authorities in other countries or jurisdictions. We may not obtain any regulatory approvals on a timely basis, if at all. We may not be able to file for marketing approvals and may not receive necessary approvals to commercialize our products in any market. If we are unable to obtain approval of any of our product candidates by regulatory authorities in countries outside the United States, the commercial prospects of that product candidate may be significantly diminished and our business prospects could decline.

~~Development of our product candidates is not complete, and we cannot be certain that our product candidates will be commercialized.~~

~~We began the commercial launch of Xtampza, our first approved product, in June 2016. Accordingly, we have only generated limited revenues from product sales. To be profitable, in addition to~~ commercializing Xtampza ~~we must successfully research, develop, obtain regulatory approval for, manufacture, launch, market~~ER.

Xtampza ER and ~~distribute product candidates under development. For each product candidate that we intend to commercialize, we must successfully meet a number of critical developmental milestones, including:~~

~~selecting and developing a drug delivery technology to deliver the proper dose of drug over the desired period of time;~~

~~determining the appropriate drug dosage that will be tolerated, safe and effective;~~

~~demonstrating the drug formulation will be stable for commercially reasonable time periods;~~

~~demonstrating that the drug is safe and effective in patients for the intended indication; and~~

~~completing the manufacturing development and scale-up to permit manufacture of our product candidates in commercial quantities and at acceptable prices.~~

The time necessary to achieve these developmental milestones for any individual product candidate is long and uncertain, and we may not successfully complete these milestones for any of our product candidates in development. We may not be able to finalize the design or formulation of any product candidate. In addition, we may select components, solvents, excipients or other ingredients to include in our product candidates that have not been previously approved for use in pharmaceutical products, which may require us to perform additional studies and may delay clinical testing and regulatory approval of our product candidates. Even after we complete the design of a product candidate, the product candidate must still be shown to be bioequivalent to an approved drug or safe and effective in required clinical trials before approval for commercialization.

WeNucynta Products are continuing to test and develop our product candidates and may explore possible design or formulation changes to address bioavailability, safety, efficacy, manufacturing efficiency and performance issues. We may not be able to complete development of any product candidates that will be safe and effective and that will have a commercially reasonable treatment and storage period. If we are unable to complete development of our product candidates, we will not be able to earn revenue from them.

~~Xtampza is, and we anticipate that our product candidates, if approved, will be,~~ subject to mandatory REMS programs, which could increase the cost, burden and liability associated with the commercialization of ~~such product and product candidates.~~these products.

The FDA has ~~approved~~imposed a class-wide REMS ~~for extended release, or~~on all IR, ER and long acting ~~or LA,~~(“LA”) opioid ~~drugs formulated with~~drug products (known as the active ingredients fentanyl, hydromorphone, methadone, morphine, oxycodone, oxymorphone, and others as part of a federal initiative to address prescription drug abuse and misuse, or the ER/LA opioid REMS. In September 2017, theOpioid Analgesic REMS). The FDA ~~announced that immediate-release, or IR, opioid drugs will be subject to the same REMS as ER/LA opioids. One of the primary goals of~~continually evaluates whether the REMS program is ~~to ensure~~meeting its goal of ensuring that the ~~benefits~~benefit of these drugs continue to outweigh ~~the risks.~~

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~~The REMS introduces new safety measures designed to reduce~~their risks, and ~~improve~~whether the safe use of opioids, while continuing to provide access to these medications for patients in pain. The REMS applies to more than 20 companies that manufacture opioid analgesics. Under the REMS, companies are required to make education programs available to prescribers based on the FDA Blueprint for Prescriber Education for Extended Release and Long Acting Opioid Analgesics. It is expected that companies will meet this obligation by providing educational grants to continuing education providers, who will develop and deliver the training. The REMS also requires companies to distribute FDA-approved educational materials to prescribers and patients on the safe use of these drugs. The companies must perform periodic assessments of the implementation of the REMS and the successgoals or elements of the program ~~in meeting its goals. The FDA will review these assessments and may require additional elements to achieve the goals of the program.~~

should be modified. If the FDA determines that aadditional measures are necessary, the modification of the Opioid Analgesic REMS ~~is necessary during review of an application,~~to impose additional or more burdensome requirements could increase the drug sponsor must agree to the REMS plan at the time of approval. Xtampza has been subject to the REMS requirement since its approval. REMS includes a Medication Guide that is dispensed with each prescription, physician training based on FDA-identified learning objectives, audits to ensure that the FDA’s learning objectives are addressed in the physician trainings, letters to prescribing physicians, professional organizations and state licensing entities alerting each to the REMS, and the establishment of a call center to provide more information about the REMS. We anticipate that our future product candidates will also be subject to these REMS requirements. There may be increased cost, administrative burden and potential liabilitycosts associated with ~~the~~ marketing ~~and sale of these types of product candidates subject to the REMS requirements, which could~~our products and/or reduce the ~~commercial benefits~~willingness of healthcare providers to ~~us from the sale of these product candidates.~~

~~If we fail to obtain the necessary final regulatory approvals, or if such approvals are limited, we will not be able to commercialize our product candidates, and we will not generate product revenues.~~

Even if we comply with all FDA pre-approval regulatory requirements, the FDA may determine that our product candidates are not safe or effective, and we may never obtain final regulatory approval for such product candidates. If we fail to obtain final regulatory approval for some or all of our product candidates, we will have fewer commercial products and correspondingly lower product revenues. Even if our product candidates receive final regulatory approval, such final regulatory approval may involve limitations on the indications and conditions of use or marketing claims forprescribe our products, ~~or may not include certain abuse-deterrence claims or clinical trial data that we~~both which would have ~~sought, and will seek, to include in the product label. If we do not receive regulatory approval to include certain abuse-deterrence claims, or certain clinical data, in our product labels,~~a material adverse effect on our ability to continue successfully ~~commercialize~~commercializing, or to generate sufficient revenue from, our ~~products may be limited and our financial results may be adversely impacted. Further, later discovery of previously unknown problems or adverse events~~products.

We could ~~result~~fail to promote Xtampza ER’s abuse deterrent labeling in additional regulatory restrictions, including withdrawal of products and addition of warnings or other statements on the product label. The FDA may require us to perform lengthy Phase 4 post-approval clinical efficacy or safety trials. Post approval, the FDA may require us to study, as it has with respect to Xtampza, the serious risks of misuse, abuse, addiction, overdose, and death associated with long-term use of our medications for the management of chronic pain, as well as other risks. The FDA may also impose additional post-marketing requirements, which will be very expensive to satisfy.

In jurisdictions outside the United States, we must receive marketing authorizations from the appropriate regulatory authorities before commercializing our product candidates. Regulatory approval processes outside the United States generally include requirements and risks similar to, and in many cases in excess of, those associatedcompliance with FDA ~~approval.~~regulations.

~~The FDA may not approve~~

Xtampza ER has FDA-approved product labeling ~~for our product candidates~~ that ~~would permit us to market and promote our products in the United States by describing their abuse-deterrent features.~~

We invest substantial time and money conducting Category 1, Category 2 and Category 3 abuse deterrent studies to ensure that our product candidates developed with our DETERx technology comply with the FDA’s April 2015 guidance regarding opioid abuse deterrence. Our failure to achieve FDA approval of product labeling containing such information will prevent or substantiality limit our promotion of thedescribes its abuse deterrent features, ~~of our product candidates in order~~which allows us to promote those features and differentiate ~~them~~Xtampza ER from other opioid products containing the same active pharmaceutical ingredients. This would make our products less competitive in the market. There can be no assurance that any of our product candidates will receive final FDA-approved product labeling that describes the abuse deterrent features of such products. Furthermore, the FDA’s April 2015 final guidance on abuse deterrent opioids makes clear that the FDA expects sponsors to compare their formulations against approved abuse deterrent versions of the same opioid based on the relevant categories of testing. If a proposed product is

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less resistant to manipulation than an approved product, the FDA has stated that the proposed product may not be eligible for product labeling regarding abuse deterrent properties. If the FDA does not approve product labeling containing abuse deterrence claims, we will not be able to promote such products based on their abuse deterrent features, may not be able to differentiate such products from other opioid products containing the same active ingredients, and may need to lower the price of our products to the extent that there are competing products with abuse deterrent claims on their product labels.

Because the FDA closely regulates promotional materials and other promotional activities, even ifthough the FDA ~~initially approves~~approved product labeling ~~that~~ includes a description of the abuse deterrent characteristics of ~~our product,~~Xtampza ER, the FDA

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may object to our marketing claims and product advertising campaigns. This could lead to the issuance of warning letters or untitled letters, suspension or withdrawal of our products from the market, recalls, fines, disgorgement of money, operating restrictions, injunctions, and civil or criminal prosecution. Any of these consequences would harm the commercial success of ~~our products.~~Xtampza ER.

Even if any of our product candidates are approved for marketing with certain abuse-deterrence claims, the April 2015 final FDA guidance on abuse-deterrent opioids is not binding law and may be superseded or modified at any time. Also, if the FDA determines that our post-marketing data do not demonstrate that the abuse-deterrent properties result in reduction of abuse, or demonstrate a shift to routes of abuse that present a greater risk, the FDA may find that product labeling revisions are needed, and potentially require the removal of our abuse-deterrence claims.

Even if our product candidates receive regulatory approval, they will be subject to ongoing regulatory requirements, and we may face regulatory enforcement action if we do not comply with the requirements.

Even after a product is approved, we will remain subject to ongoing FDA and other regulatory requirements governing the product labeling, packaging, storage, distribution, safety surveillance, advertising, promotion, import, export, record-keeping and reporting of safety and other post-market information. If we experience delays in obtaining FDA approval of our advertising and promotional materials for Xtampza or any product candidate that receives marketing approval, or if FDA approval of such materials is contingent upon substantial modifications, our promotional efforts relating to Xtampza and any approved product candidate may be impaired, and sales of such products may suffer.

The holder of an approved NDA is obligated to monitor and report adverse events, or AEs, and any failure of a product to meet the specifications in the NDA. 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 current good manufacturing practices, or cGMP, and other regulations. If we or a regulatory agency discover problems with a product which were previously unknown, such as adverse events of unanticipated severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring product recall, notice to physicians, withdrawal of the product from the market or suspension of manufacturing, among other things. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, a regulatory agency may:

~~issue warning letters or untitled letters;~~

~~mandate modifications to promotional materials or require us to provide corrective information to healthcare practitioners;~~

require us to enter into a consent decree, which can include the imposition of various fines, reimbursements for inspection costs and penalties for noncompliance, and require due dates for specific actions;

seek an injunction or impose civil, criminal and/or administrative penalties, damages, monetary fines, require disgorgement, consider exclusion from participation in Medicare, Medicaid and other federal healthcare programs and require curtailment or restructuring of our operations;

~~suspend or withdraw regulatory approval;~~

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~~suspend any ongoing clinical trials;~~

~~refuse to approve pending applications or supplements to applications filed by us;~~

~~suspend or impose restrictions on operations, including costly new manufacturing requirements;~~

~~seize or detain products, refuse to permit the import or export of products, or require us to initiate a product recall; or~~

~~refuse to allow us to enter into government contracts.~~

Similar post-market requirements may apply in foreign jurisdictions in which we may seek approval of our products. 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 our products and generate revenue and may cause a material adverse impact on our financial condition and cash flows.

In addition, the FDA’s regulations, policies or guidance may change and new or additional statutes or government regulations in the United States and other jurisdictions may be enacted that could further restrict or regulate post-approval activities. We cannot predict the likelihood, nature or extent of adverse government regulation that may arise from pending or future legislation or administrative action, either in the United States or abroad. If we are not able to achieve and maintain regulatory compliance, we may not be permitted to market our products and/or product candidates, which would adversely affect our ability to generate revenue and achieve or maintain profitability.

Failure to comply with ongoing governmental regulations for marketing any product, including Xtampza ER and the Nucynta Products, could delay or inhibit our ability to generate revenues from their sale and could also expose us to claims or other sanctions.

Advertising and promotion of any pharmaceutical product ~~that obtains approval~~marketed in the United States, including Xtampza ~~will be~~ER and the Nucynta Products, is heavily scrutinized by, among others, the FDA, the Department of Justice, ~~or the DOJ,~~ the Office of Inspector General offor the U.S. Department of Health and Human Services ~~or HHS,~~(“HHS”), state attorneys general, members of Congress and the public. Violations, including promotion of ~~Xtampza, and any product for which we receive final regulatory approval,~~our products for unapproved or off-label uses, are subject to enforcement letters, inquiries and investigations, and civil and criminal sanctions by the FDA or other government agencies. ~~Additionally, advertising and promotion of any product that obtains approval outside the United States will be heavily scrutinized by foreign regulatory authorities.~~

~~In the United States, engaging~~

Engaging in off-label promotion of ~~Xtampza, or any~~our products ~~can~~could also subject us to false claims ~~litigation~~liability under federal and state statutes, and other litigation and/or ~~investigation,~~investigations, which ~~can~~could lead to civil and criminal penalties and fines, and could also require us to enter into agreements that materially restrict the manner in which we promote or distribute our drug products. These false claims statutes include the federal False Claims Act, which allows any individual to bring a lawsuit against a pharmaceutical company on behalf of the federal government alleging submission of false or fraudulent claims, or causing to present such false or fraudulent claims, for payment by a federal program such as Medicare or Medicaid. If the government prevails in the lawsuit, the individual will share in any fines or settlement funds. False Claims Act lawsuits against pharmaceutical companies have increased significantly in volume and breadth in recent years, leading to several substantial civil and criminal settlements based on certain sales practices promoting off-label drug uses. This increased focus and scrutiny has increased the risk that a pharmaceutical company will have to defend a false claim action, pay settlement fines or restitution, agree to comply with burdensome reporting and compliance obligations, and be excluded from the Medicare, Medicaid and other federal and state healthcare programs.

If we are found to have promoted such off-label uses, we may become subject to significant liability. The federal government has levied large civil and criminal fines against companies for alleged off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If we cannot successfully manage the promotion of our products, we could become subject to significant liability, which could materially adversely affect our business and financial condition.

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In addition, ~~later~~after product approval, subsequent discovery of ~~previously unknown~~serious and unanticipated adverse events associated with the product; the emergence of other problems with athe product, manufacturer or ~~facility,~~facility; or our failure to ~~update~~make required regulatory ~~files,~~submissions may result in ~~restrictions,~~adverse regulatory actions, including withdrawal of the product from the ~~market. Any~~market or the requirement to add or strengthen label warnings about the product. The failure to obtain or maintain requisite governmental approvals or the imposition of ~~the following~~additional or ~~other similar events, if they were to occur,~~stronger warnings could delay or preclude us from further developing, marketing or realizing the full commercial potential of ~~Xtampza and our product candidates:~~

~~failure to obtain or maintain requisite governmental approvals;~~

~~failure to obtain approvals of product labeling with abuse-deterrent claims; or~~

~~FDA required product withdrawals or warnings arising from identification of serious and unanticipated adverse side effects in our product candidates.~~

Xtampza and our product candidates contain controlled substances, the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state, federal and foreign law enforcement and other regulatory agencies.

Xtampza and our product candidates contain, and our future product candidates will likely contain, controlled substances which are subject to state, federal and foreign laws and regulations regarding their manufacture, use, sale, importation, exportation and distribution. Xtampza’s active ingredient, oxycodone, is classified as a controlled substance under the Controlled Substances Act of 1970, or CSA, and regulations of the U.S. Drug Enforcement Administration, or DEA. A number of states also independently regulate these drugs, including oxycodone, as controlled substances. Controlled substances are classified by the DEA as Schedule I, II, III, IV or V substances, with Schedule I substances considered to present the highest risk of substance abuse and Schedule V substances the lowest risk. The active ingredient in Xtampza, oxycodone, is listed by the DEA as a Schedule II controlled substance under the CSA. For our product candidates containing controlled substances, we and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state, federal and foreign law enforcement and regulatory agencies and comply with state, federal and foreign laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances. For example, all Schedule II drug prescriptions must be signed by a physician, physically presented to a pharmacist and may not be refilled without a new prescription.

Furthermore, the amount of Schedule II substances that can be obtained for clinical trials and commercial distribution is limited by the CSA and DEA regulations. We may not be able to obtain sufficient quantities of these controlled substances in order to complete our clinical trials or meet commercial demand. If commercial demand for Xtampza increases and we cannot meet such demand in a timely fashion because of our limited supply of its active ingredient, oxycodone, then physicians may perceive Xtampza as unavailable and may be less likely to prescribe it in the future.

In addition, controlled substances are also subject to regulations governing manufacturing, labeling, packaging, testing, dispensing, production and procurement quotas, recordkeeping, reporting, handling, shipment and disposal. These regulations increase the personnel needs and the expense associated with development and commercialization of Xtampza and product candidates that include controlled substances. The DEA and some states conduct periodic inspections of registered establishments that handle controlled substances.

Failure to obtain and maintain required registrations or to comply with any applicable regulations could delay or preclude us from developing and commercializing Xtampza and product candidates that contain controlled substances and subject us to enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature, these regulations could limit commercialization of products containing controlled substances.

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Clinical development is a lengthy and expensive process with an uncertain outcome, and failure can occur at any stage of clinical development. If we are unable to design, conduct and complete clinical trials successfully, our product candidates will not be able to receive regulatory approval.

In order to obtain FDA approval for any of our product candidates, we must submit to the FDA an NDA with substantial evidence that demonstrates that the product candidate is both safe and effective in humans for its intended use. This demonstration requires significant research, preclinical studies and clinical trials.

Other than Onsolis, all of our product candidates are in preclinical and clinical development. Clinical trials are time-consuming, expensive and difficult to design and implement, in part because they are subject to rigorous requirements and their outcomes are inherently uncertain. Clinical testing may take many years to complete, and failure can occur at any time during the clinical trial process, even with active ingredients that have previously been approved by the FDA as being safe and effective. We could encounter problems that halt our clinical trials or require us to repeat such clinical trials. If patients participating in clinical trials suffer drug-related adverse reactions during the clinical trials, or if we or the FDA believe that patients are being exposed to unacceptable health risks, such clinical trials may be suspended or terminated. Suspensions, termination or the need to repeat a clinical trial can occur at any stage.

The clinical trial success of each of our product candidates depends on reaching statistically significant changes in patients’ symptoms based on clinician-rated scales. There is a lack of consensus regarding standardized processes for assessing clinical outcomes based on clinician-rated scales. Accordingly, the scores from our clinical trials may not be reliable, useful or acceptable to the FDA or other regulatory agencies.

Changes in standards related to clinical trial design could have a material adverse effect on our ability to design and conduct clinical trials as planned. For example, we have conducted or will conduct clinical trials comparing our product candidates to both placebo and other approved drugs, but regulatory authorities may not allow us to compare our product candidates to a placebo in a particular clinical indication where approved products are available. In that case, both the cost and the amount of time required to conduct a clinical trial could increase. The FDA may disagree with our trial design and our interpretation of data from clinical trials, or may change the requirements for approval even after it has reviewed and commented on the design for our clinical trials. The FDA may also approve a product candidate for fewer or more limited indications than we request, or may grant approval contingent on the performance of costly post-approval clinical trials. In addition, the FDA may not approve the product labeling claims or removal of certain warnings that we believe are necessary or desirable for the successful commercialization of our product candidates.

~~Approval may be contingent on a REMS, which could have a material adverse effect on the product labeling, distribution or promotion of a drug product.~~

Any of these delays or additional requirements could cause our product candidates to not be approved, or if approved, significantly impact the timing of commercialization and significantly increase our overall costs of drug development.

Because the results of preclinical studies and early-stage clinical trials are not necessarily predictive of future results, any product candidate we advance into additional clinical trials may not continue to have favorable results or receive regulatory approval.

Other than Onsolis, all of our product candidates are in preclinical or early-stage clinical development. Success in preclinical studies and early clinical trials does not ensure that later clinical trials will generate adequate data to demonstrate the efficacy and safety of an investigational drug. Many companies in the pharmaceutical and biotechnology industries, including those with greater resources and experience, have suffered significant setbacks in clinical trials, even after positive results in earlier clinical trials. Despite preliminary preclinical studies for our other extended-release, abuse deterrent product candidates, including hydrocodone and oxymorphone for pain, and methylphenidate for the treatment of ADHD, we do not know whether the clinical trials we may conduct will demonstrate adequate efficacy and safety or otherwise provide adequate information to result in regulatory approval to market any of our product candidates in any particular jurisdiction. If later-stage clinical trials do not produce favorable results, our ability to achieve regulatory approval for any of our product candidates may be compromised.

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Conducting clinical trials of Xtampza and our product candidates and any commercial sales of Xtampza and/or product candidates may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all.

We currently carry product liability insurance with coverage up to approximately $10.0 million. Product liability claims may be brought against us by patients enrolled in our clinical trials, patients, healthcare providers or others using, administering or selling our products. If we cannot successfully defend ourselves against claims that our products or product candidates caused injuries, we could incur substantial liabilities. We may not be able to maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Regardless of merit or eventual outcome, liability claims may result in:

~~decreased demand for any product or product candidates that we may develop;~~

~~termination of clinical trial sites or entire trial programs;~~

~~injury to our reputation and significant negative media attention;~~

~~withdrawal of clinical trial participants;~~

~~significant costs to defend the related litigation;~~

~~substantial monetary awards to patients;~~

~~loss of revenue;~~

~~diversion of management and scientific resources from our business operations;~~

~~the inability to commercialize any products that we may develop; and~~

~~an increase in product liability insurance premiums or an inability to maintain product liability insurance coverage.~~

Our inability to maintain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of Xtampza and our product candidates. Any agreements we may enter into in the future with collaborators in connection with the development or commercialization of Xtampza and our product candidates may entitle us to indemnification against product liability losses, but such indemnification may not be available or adequate should any claim arise. In addition, many of our agreements require us to indemnify third parties and these indemnifications obligations may exceed the coverage under our product liability insurance policy.

Xtampza and our product candidates may be associated with undesirable adverse reactions or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of their approved product label, or result in significant negative consequences following any marketing approval.

Undesirable adverse reactions associated with Xtampza and our product candidates could cause us, our IRBs, clinical trial sites or regulatory authorities to interrupt, delay or halt clinical trials and could result in a restrictive product label or the delay, denial or withdrawal of regulatory approval by the FDA or foreign regulatory authorities. For example, even though Xtampza has generally been well tolerated by patients in our clinical trials, in some cases there were adverse reactions, one of which was a serious adverse event, moderate in severity, of gastroesophageal reflux.

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If we or others identify undesirable adverse events associated with Xtampza or any product candidate for which we receive final regulatory approval, a number of potentially significant negative consequences could result, including:

~~we may be forced to suspend marketing of the product;~~

~~regulatory authorities may withdraw their approvals of the product or impose restrictions on its distribution;~~

~~regulatory authorities may require additional warnings or contradictions in the product label that could diminish the usage or otherwise limit the commercial success of the product;~~

~~we may be required to conduct additional post-marketing studies;~~

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

~~our reputation may suffer.~~

~~Any of these events could prevent us from achieving or maintaining market acceptance of Xtampza or any of our product candidates, if approved.~~

Risks Related to Intellectual Property

Unfavorable outcomes in intellectual property litigation could result in costly litigation and potentially limit our ability to commercialize our products.

Our commercial success depends upon our ability to ~~develop product candidates and~~ commercialize products without infringing the intellectual property rights of others. Our current or future ~~product candidates or~~ products, or any uses of them, may now or in the future infringe third-party patents or other intellectual property rights. This is due in part to the considerable uncertainty within the pharmaceutical industry about the validity, scope and enforceability of many issued patents in the United States and elsewhere in the world and, to date, there is no consistency regarding the breadth of claims allowed in pharmaceutical patents. We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted to be infringed by the manufacture, use and sale of our products. In part as a result of this uncertainty, there has been, and we expect that there will continue to be, significant litigation in the pharmaceutical industry regarding patents and other intellectual property rights.

Third parties may assert infringement claims against us, or other parties we have agreed to indemnify, based on existing patents or patents that may be granted in the future. We are aware of third-party patents and patent applications related to oxycodone, oxymorphone, hydrocodone, morphine, and methylphenidate drugs and formulations, including those listed in the FDA’s Orange Book for oxycodone products. Because of the delay between filing and publication of patent applications, and because applications can take several years to issue, there may be currently pending third-party patent applications that are unknown to us, which may later result in issued patents. Because of the uncertainty inherent in intellectual property litigation, we could lose, even if the case against us was weak or flawed.

If we are found to infringe a third party’s intellectual property rights, we could be required to obtain a license from such third party to continue developing or commercializing ~~Xtampza or~~ our ~~product candidates,~~ products and technology. However, we may not be able to obtain any required license on commercially reasonable terms or at all. Even if we are able to obtain a license, it may be non-exclusive, thereby giving our competitors access to the same technologies licensed to us. We could be forced, including by court order, to cease commercializing the infringing technology or product. In addition, in any such proceeding or litigation, we could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent. A finding of infringement could prevent us from commercializing ~~Xtampza or~~ our ~~product candidates~~products or force us to cease some of our business operations.

In connection with any NDA that we file under Section 505(b)(2), including the NDA for Xtampza, we are required to notify the patent holder of the reference listed drug that we identify in our NDA, that we have certified to the FDA that

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any patents listed for the listed drug in the FDA’s Orange Book publication are invalid, unenforceable or will not be infringed by the manufacture, use or sale of our drug. If the patent holder files a patent infringement lawsuit against us within 45 days of its receipt of notice of our certification, the FDA is automatically prevented from approving our Section 505(b)(2) NDA until the earliest of 30 months after the lawsuit is filed, expiration of the patents, settlement of the lawsuit and a court decision in the infringement case that is favorable to us. Accordingly, we may invest significant time and expense in the development of our product candidates only to be subject to significant delay and patent litigation before our product candidates may be commercialized.

If we are found by the court to have infringed a valid patent claim, we could be prevented from using the patented technology or be required to pay the patent holder for the right to license the patented technology. If we decide to pursue a license to use 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, such as Purdue, that competitor may choose not to license patent rights to us. If we decide to develop alternative technology, we may not be able to do so in a timely or cost-effective manner, if at all.

Even if we are found not to infringe or patent claims are found invalid or unenforceable, defending any such infringement claim would be expensive and time consuming, and could delay the approval or commercialization of our product candidates and distract management from their normal responsibilities.

~~Competitors may sue us as a way of delaying the introduction of our products.~~ Any litigation, including any interference or derivation proceedings to determine priority of inventions, oppositions or other post-grant review proceedings to patents in ~~the United States or in countries outside~~ the United States, or litigation against our collaborators may be costly and time consuming and could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. We expect that litigation may be necessary in some instances to determine the validity and scope of our proprietary rights. Litigation may be necessary in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the outcome of such litigation, including our pending litigation with Purdue, could compromise the validity and scope of our patents or other proprietary rights or hinder our ability to manufacture and market our products.

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If we are unable to obtain or maintain intellectual property rights for our ~~technology,~~technologies, products ~~and~~or any future product candidates which we may develop, we may lose valuable assets or ~~experience reduced market share.~~be unable to compete effectively in our market.

We depend on our ability to protect our proprietary technology. We rely on patent and trademark laws, unpatented trade secrets and know-how, and confidentiality, licensing and other agreements with employees and third parties, all of which offer only limited protection. Our success depends in large part on our ability to obtain and maintain patent protection in the United States ~~and other countries~~ with respect to our proprietary technology and ~~product candidates.~~products.

The steps we have taken to protect our proprietary rights may not be adequate to preclude misappropriation of our proprietary information or infringement of our intellectual property rights ~~both inside and outside~~in the United States. The rights already granted under any of our currently issued patents and those that may be granted under future issued patents may not provide us with the proprietary protection or competitive advantages we are seeking.

The patent prosecution process is expensive and time-consuming, and we may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we will fail to identify patentable aspects of inventions made in the course of our development and commercialization activities before it is too late to obtain patent protection on them.

Given the amount of time required for the development, testing and regulatory review of product candidates, patents protecting such product candidates might expire before or shortly after such product candidates are commercialized. If we are unable to obtain and maintain patent protection for our technology and products, or if the scope of the patent protection obtained is not sufficient, our competitors could develop and commercialize technology and products identical, similar or superior to ours, and our ability to successfully commercialize our technology and products may be adversely affected.

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With respect to patent rights, our patent applications may not issue into patents, and any issued patents may not provide protection against competitive technologies, may be held invalid or unenforceable if challenged or may be interpreted in a manner that does not adequately protect our technology, product candidates or future product candidates. Even if our patent applications issue into patents, they may not issue in a form that will provide us with any meaningful protection, prevent competitors from competing with us, or otherwise provide us with any competitive advantage. The examination process may require us to narrow the claims in our patents, which may limit the scope of patent protection that may be obtained. Our competitors may design around or otherwise circumvent patents issued to us or licensed by us.

~~The scope of patent protection in the United States and in foreign jurisdictions is highly uncertain, and changes in U.S. and foreign patent law~~We have ~~increased that uncertainty and could diminish the value of patents in general, thereby impairing our ability to protect our product candidates and any future products.~~

~~The patent position of pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions and has in recent years~~ been, the subject of much litigation. Changes in either the patent laws or interpretation of the patent laws in the United States and other countries may diminish the value of our patents or narrow the scope of our patent protection. The laws of foreign countries may not protect our rights to the same extent as the laws of the United States, and these foreign laws may also be subject to change.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions typically are not published until 18 months after filing or, in some cases, not at all. Therefore, we cannot be certain that we were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we were the first to file for patent protection of such inventions. As a result, the issuance, scope, validity, enforceability and commercial value of our patent rights, both in the United States and abroad, are highly uncertain.

Recent patent reform legislation could increase the uncertainties and costs associated with the prosecution of our patent applications and the enforcement or defense of our issued patents. The Leahy-Smith America Invents Act, or the Leahy-Smith Act, which was signed into law on September 16, 2011, made significant changes to U.S. patent law, including provisions that affect the way patent applications are prosecuted and litigated. Many of the substantive changes to patent law associated with the Leahy-Smith Act and, in particular, the “first to file” provisions described below, only became effective on March 16, 2013. The Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents.

Pursuant to the Leahy-Smith Act, the United States transitioned to a “first to file” system in which the first inventor to file a patent application will be entitled to the patent. In addition, third parties are allowed to submit prior art before the issuance of a patent by the U.S. Patent and Trademark Office, or USPTO, and may become involved in opposition, derivation, reexamination, or inter partes review challenging our patent rights or the patent rights of others. Grounds for a validity challenge could be an alleged failurecontinue to meet any of several statutory requirements, including novelty, nonobviousness and enablement. It is possible that prior art of which both we and the patent examiner were unaware during prosecution exists, which could render our patents invalid. Moreover, there may exist prior art of which we were or are aware, and which we did not or do not consider relevant to our patents, but which could nevertheless be determined to render our patents invalid. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, which could have a material adverse effect on our competitive position with respect to third parties.

Because the issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, issued patents that we own or license from third parties may be challenged in the courts or patent offices in the United States and abroad. Such challenges may result in the loss of patent protection, the narrowing of claims in such patents, or the invalidity or unenforceability of such patents, which could limit our ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection for our technology and products. Protecting against the unauthorized use of our patented technology, trademarks and other intellectual property rights is expensive, difficult and, may in some cases not be possible. In some cases, it may be difficult or impossible to detect third party infringement or misappropriation of our intellectual property rights, even in relation to issued patent claims, and proving any such infringement may be even more difficult.

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~~We may~~ be, forced to litigate to enforce or defend our intellectual property, which could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets.

We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property rights against infringement and unauthorized use by competitors, and to protect our trade secrets. To counter infringement or unauthorized use, litigation may be necessary in the future to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity and scope of our own intellectual property rights. In so doing, we may place our intellectual property at risk of being invalidated, rendered unenforceable or limited or narrowed in scope.

~~Further, this can be~~This litigation is expensive and time consuming. Many of our current and potential competitors have the ability to dedicate substantially greater resources to defend their intellectual property rights than we can.

Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating our intellectual property. Litigation could result in substantial costs and diversion of management resources, which could have a material adverse effect on our operating results, our ability to raise capital needed to commercialize products and our overall financial condition. In addition, an adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, held unenforceable or interpreted narrowly. Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during litigation. There could also 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 material adverse effect on the price of shares of our common stock.

~~We may be subject to claims by third parties of ownership of what we regard as our own intellectual property or obligations to make compensatory payments to employees or others.~~

While it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing or obtaining such an agreement with each party who, in fact, develops intellectual property that we regard as our own. In addition, they may breach the assignment agreements or such agreements may not be self-executing, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Such intellectual property rights could be awarded to a third party, and we could be required to obtain a license from such third party to commercialize our technology or products. Such a license may not be available on commercially reasonable terms or at all. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.

In addition to seeking patents for some of our technology ~~products~~ and ~~product candidates,~~products, we rely on trade secrets, including unpatented know-how, technology and other proprietary information, to maintain our competitive position. We seek to protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. Despite these efforts, any of these parties may breach the agreements and disclose our proprietary information, including our trade secrets, and we may not be able to obtain adequate remedies for such breaches. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts ~~both within and outside~~in the United States may be less willing or unwilling to protect trade secrets. If any of our trade secrets were to be lawfully obtained or independently developed by a competitor, we would have no right to prevent such competitor, or those towith whom they communicate, ~~with,~~ from using that technology or information to compete with us. If any of our trade secrets were to be disclosed or independently developed, our competitive position would be harmed.

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

Filing, prosecuting and defending patents on all of our product candidates throughout the world would be prohibitively expensive. Competitors may use our technologies in jurisdictions where we have not obtained patent protection to develop and sell their own products and, further, may export otherwise infringing products to territories where we have patent protection but enforcement is not as strong as that in the United States. These products may compete with our products in jurisdictions where we do not have any issued patents or our patent claims or other intellectual property rights may not be effective or sufficient to prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to pharmaceuticals, which could make it difficult for us to stop the infringement of our patents or the marketing of competing products in violation of our proprietary rights generally. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial cost and divert our efforts and attention from other aspects of our business.

~~We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.~~

Many of our employees, including our senior management, were previously employed at other biotechnology or pharmaceutical companies, including potential competitors. These employees typically executed proprietary rights, non-disclosure and non-competition agreements in connection with their previous employment. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. We are not aware of any threatened or pending claims related to these matters, but in the future litigation may be necessary to defend against such claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs, damage our reputation and be a distraction to management.

Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.

The USPTO ~~and various foreign governmental patent agencies require~~requires compliance with a number of procedural, documentary, fee payment and other similar provisions during the patent application process. In addition, periodic maintenance fees on issued patents are required to be paid to the USPTO ~~and foreign patent agencies~~ in several stages over the lifetime of the patents. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, 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. Non-compliance events that could result in abandonment or lapse of a patent or patent application include, but are not limited to, failure to respond to official actions within prescribed time

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limits, non-payment of fees, and failure to properly legalize and submit formal documents. If we fail to maintain the patents and patent applications covering our ~~product candidates,~~products, our competitive position would be adversely affected.

Risks Related to the Commercialization of Our ~~Product Candidates~~Products

~~We currently have limited sales and marketing capabilities and, if~~

If we are unable to ~~successfully~~ utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing ~~Xtampza and~~ our ~~product candidates~~products and may be unable to generate sufficient product revenue.

~~Although our executive officers have experience marketing pharmaceutical products,~~

Our commercial organization continues to evolve and we ~~currently have limited sales, marketing or distribution capabilities. Our sales and marketing team has worked together for only a limited period of time. We~~ cannot guarantee that we will continue to be successful in marketing ~~Xtampza or any of~~ our ~~product candidates which may~~

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~~be approved for marketing.~~products. In addition, we ~~will have to~~ compete with other pharmaceutical and biotechnology companies with extensive and well-funded sales and marketing operations to recruit, hire, train and retain sales and marketing personnel. If we are unable to ~~establish~~continue to grow and maintain adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate sufficient product revenue and may not ~~become~~remain profitable. Factors that may inhibit our efforts to ~~commercialize~~continue successfully commercializing our ~~product candidates~~products in the United States include:

●

our inability to recruit and retain adequate numbers of effective sales and marketing personnel;

●

the inability of sales personnel to ~~obtain access to or persuade~~reach adequate numbers of physicians towho may prescribe ~~Xtampza~~our products; and ~~our product candidates;~~

●

~~the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and~~

unforeseen costs and expenses associated with creating and maintaining an independent sales and marketing organization.

If we are not successful in ~~recruiting and~~ retaining sales and marketing personnel or in ~~building a~~maintaining our sales and marketing infrastructure or if we do not ~~successfully enter into appropriate~~preserve strategic alliances with marketing collaborators, agreements with contract sales organizations or collaboration arrangements, we will have difficulty ~~commercializing Xtampza or~~in continuing to commercialize our ~~product candidates. To the extent we commercialize Xtampza or~~products.

Additionally, our ~~product candidates by entering into agreements with third-party collaborators, we may have limited or no control over the~~ sales, marketing and distribution ~~activities of these third parties, in which case our future revenues would depend heavily on the success~~capabilities may be hindered as a result of the COVID-19 outbreak. In response to the outbreak, our sales personnel transitioned partly or entirely to remote work. The safety and well-being of our employees is our highest priority and we expect to maintain mitigating measures until such time as mandated closures or other restrictions are lifted and public health officials change their recommendations, and we have, and will continue to, equip our personnel with the tools and resources needed to effectively continue their sales and marketing efforts in a manner that complies with all relevant regulations, whether in person or from a remote setting. We face the risk, however, that limitations on activities within the healthcare sector and on economic activity generally will impede our ability to continue successfully commercializing our products. Notwithstanding the lifting of ~~these third parties.~~COVID-19 restrictions in many jurisdictions, and amidst continuing public health concerns relating to the spread of COVID-19, weekly pain patient office visits continue to be depressed compared to pre-COVID periods, which in turn may account for fewer patients beginning therapy with our products. We believe that the disruptions caused by COVID-19 will continue and there remains substantial uncertainty as to when such disruptions will cease. If we are unable to successfully commercialize our products during the COVID-19 outbreak, our ability to generate sufficient product revenue may be adversely affected.

If ~~physicians, patients, healthcare payors and~~ the medical community, patients, and healthcare payors do not accept and use ~~Xtampza or~~ our ~~product candidates,~~products, we will not achieve sufficient product revenues and our business will suffer.

Physicians ~~patients, healthcare payors~~ and others in the medical community, patients, and healthcare payors may not accept and use ~~Xtampza or any of~~ our ~~product candidates, for which we receive final regulatory approval.~~products. Acceptance and use of ~~Xtampza and any product candidates for which we receive final regulatory approval~~our products will depend on a number of factors including:

●

~~the timing of market introduction of Xtampza and the product candidates as well as competitive products;~~

approved indications, warnings and precautions language that may be less desirable than ~~anticipated;~~

competitive products;

●

perceptions by members of the healthcare community, including physicians, about the safety and efficacy of ~~Xtampza and~~ our ~~product candidates, and, in particular,~~products;

●

perceptions by members of the healthcare community, including physicians, about the relevance and efficacy of our abuse deterrent ~~technology in reducing potential risks~~technology;

●

the availability of ~~unintended use;~~

competitive products;

●

~~perceptions by physicians regarding~~ the ~~cost benefit of Xtampza~~pricing and ~~our product candidates in reducing potential risks of unintended use;~~

~~published studies demonstrating the~~ cost-effectiveness of ~~Xtampza and~~ our ~~product candidates~~products relative to competing products;

●

the potential and perceived advantages of ~~Xtampza and~~ our ~~product candidates~~products over alternative treatments;

●

the convenience and ease of administration to patients of ~~Xtampza and~~ our ~~product candidates;~~

products;

●

actual and perceived availability and quality of coverage and reimbursement for ~~Xtampza and~~ our ~~product candidates~~products from government or other third-party payors;

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●

any negative publicity related to our products or negative or positive publicity related to our competitors’ ~~products that include the same active ingredient as Xtampza and our product candidates;~~

products;

●

the prevalence and severity of adverse side ~~effects, including limitations~~effects;

●

policy initiatives by FDA, HHS, or ~~warnings contained in a product’s FDA approved product labeling;~~

other federal or state agencies regarding opioids;

●

our ability to ~~implement a~~comply with the Opioid Analgesic REMS; and

●

the effectiveness of marketing and distribution efforts by us and any licensees and distributors.

If ~~Xtampza or~~ our ~~product candidates for which we receive final regulatory approval,~~products fail to ~~achieve~~have an adequate level of acceptance by ~~physicians, healthcare payors, patients or~~ the medical community, patients, or healthcare payors, we will not be able to generate ~~significant~~sufficient revenue ~~and we may not become or~~to remain profitable. Since we expect to rely on sales generated by Xtampza ER and the Nucynta Products for substantially all of our revenues for the foreseeable future, the failure of Xtampza ER or the Nucynta Products to ~~find~~maintain market acceptance would harm our business prospects.

~~Recently enacted~~

Our products contain, and our future product candidates may contain, controlled substances, the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies.

Our products contain, and our future product candidates may contain, controlled substances that are subject to state and federal laws and regulations regarding their manufacture, use, sale, importation, exportation and distribution. Xtampza ER’s active ingredient, oxycodone, and the Nucynta Products’ active ingredient, tapentadol, are both classified as Schedule II controlled substances under the CSA and regulations of the DEA. A number of states also independently regulate these drugs, including oxycodone and tapentadol, as controlled substances. We and our suppliers, manufacturers, contractors, customers and distributors are required to obtain and maintain applicable registrations from state and federal law enforcement and regulatory agencies and comply with state and federal laws and regulations regarding the manufacture, use, sale, importation, exportation and distribution of controlled substances.

Furthermore, the amount of Schedule II substances that can be obtained for clinical trials and commercial distribution is limited by the CSA and DEA regulations. For more information, see the section in our Annual Report entitled “Business—Government Regulation—DEA and Opioid Regulation.” We may not be able to obtain sufficient quantities of these controlled substances in order to meet commercial demand. If commercial demand for Xtampza ER, or any of our other approved products, increases and we cannot meet such demand in a timely fashion because of our limited supply of its active pharmaceutical ingredient (in the case of Xtampza ER, oxycodone) then physicians may perceive such product as unavailable and may be less likely to prescribe it in the future.

In addition, controlled substances are also subject to regulations governing manufacturing, labeling, packaging, testing, dispensing, production and procurement quotas, recordkeeping, reporting, handling, shipment and disposal. These regulations increase the personnel needs and the expense associated with development and commercialization of our products that include controlled substances. The DEA and some states conduct periodic inspections of registered establishments that handle controlled substances.

Failure to obtain and maintain required registrations or to comply with any applicable regulations could delay or preclude us from developing and commercializing our products that contain controlled substances and subject us to enforcement action. The DEA may seek civil penalties, refuse to renew necessary registrations or initiate proceedings to revoke those registrations. In some circumstances, violations could lead to criminal proceedings. Because of their restrictive nature, these regulations could limit commercialization of our products containing controlled substances.

Current and future legislation may increase the difficulty and cost for us to continue to commercialize ~~Xtampza and~~ our ~~product candidates~~products and may reduce the prices we are able to obtain for our products.

In the United States, ~~and some foreign jurisdictions,~~ there have been a number of legislative and regulatory changes and proposed changes regarding the healthcare system generally, and the manufacturing, distribution, and marketing of opioids in particular, that could prevent or delay marketing approval of ~~our~~future product candidates, restrict or regulate post-approval activities or affect our ability to profitably sell ~~Xtampza or any product candidates~~our products for which we obtain marketing approval.

~~Cost reduction legislation could decrease~~ For example, several states, including New York, have recently imposed taxes or fees on the ~~coverage~~sale of opioids. Other states, and ~~price that we receive for any approved products, including for reimbursement through Medicare and private payors.~~

~~The pricing of pharmaceutical products, in general, and specialty drugs, in particular, has also been a topic of concern~~even the federal government, as proposed in the ~~U.S. government. There~~LifeBOAT Act introduced by a bipartisan group of Senators in May 2021, could impose similar taxes or fees, and such laws and proposals can ~~be no assurance as~~vary in the tax and fee amounts imposed and the means of calculation. Liabilities for taxes or assessments under any such laws could have an adverse impact on our results of operations.

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California and several other states have enacted legislation related to ~~how~~prescription drug pricing transparency and it is unclear the effect this ~~scrutiny~~legislation will have on ~~pricing of pharmaceutical products will impact future pricing of~~ our products or pharmaceutical products generally. The current administration has indicated that reducing the price of prescription drugs will be a priority of the administration. The implementation of any price controls on prescription drugs, whether at the federal or state level, may adversely affect our business, operating results and financial condition.

business. Laws intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add new transparency requirements for health care and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms may continue the downward pressure on pharmaceutical pricing, especially under the Medicare program, and may also increase our regulatory burdens and operating costs. We expect that the Affordable Care Act, as well as other healthcare reform measures that have been and may be adopted in the future, may result in more rigorous coverage criteria, new payment methodologies and in additional downward pressure on the price that we receive for any approved product, and could seriously harm our future revenues. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may compromise our ability to generate revenue, attain profitability or commercialize our products.

There have been repeated calls to repeal the Affordable Care Act. Any new laws or regulations that have the effect of imposing additional costs or regulatory burden on pharmaceutical manufacturers, or otherwise negatively affect the industry, would adversely affect our ability to successfully commercialize Xtampza and our product candidates, if approved.

Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for pharmaceutical products. We cannot be 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 ~~product candidates, if any,~~products may be. In addition, increased scrutiny by the U.S.

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Congress of the FDA’s approval process may ~~significantly delay or prevent marketing approval, as well as~~ subject us to more stringent product labeling and post-marketing testing and other requirements.

In addition, state pharmacy laws may permit pharmacists to substitute generic products for branded products if the products are therapeutic equivalents, or may permit pharmacists and pharmacy benefit managers to seek prescriber authorization to substitute generics in place of Xtampza or our product candidates, which could significantly diminish demand for them and significantly impact our ability to successfully commercialize our products and generate revenues.

~~Even if we are able to commercialize Xtampza and any of our product candidates, our~~Our products may become subject to unfavorable pricing regulations or third-party coverage and reimbursement policies, which could have a material adverse effect on our business. Such pricing regulations may address the rebates that manufacturers offer to pharmaceutical benefit managers, or the discounts that manufacturers provide others within the pharmaceutical distribution chain.

The regulations that govern marketing approvals, pricing and reimbursement for new drug products can vary ~~widely from country to country.~~widely. 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 drug 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 our commercial launch of the product, possibly for lengthy time periods, which could negatively impact the revenues we are able to generate from the sale of the product in that particular country. Pricing limitations may hinder our ability to recoup our investment in ~~Xtampza and~~ our ~~product candidates even if our product candidates obtain marketing approval.~~products.

Our ability to commercialize any product successfully will also depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors ~~such as private health insurers and health maintenance organizations,~~ determine which medications they will cover and establish reimbursement ~~levels.~~levels and tiers of preference based on the perceived value and innovation of a given product. A primary trend in the U.S. healthcare industry and elsewhere is cost containment. Government authorities and other third-party payors have attempted to control costs by limiting coverage and the amount of reimbursement for particular ~~medications.~~medications and establishing administrative hurdles that incentivize use of generic and/or lower cost products first. Increasingly, third-party payors are requiring that drug companies provide them with discounts and rebates from list prices and are challenging the prices charged for medical products. We have agreed to provide such discounts and rebates to certain third-party payors. We expect increasing pressure to offer larger discounts and rebates. Additionally, a greater number of third-party payors may seek discounts and rebates in order to offer or maintain access for ~~Xtampza and~~ our ~~product candidates, if approved.~~products. We cannot be sure that high-quality coverage and reimbursement will be available for any product that we commercialize and, if reimbursement is available, what the level of reimbursement will be and whether it will be satisfactory. Coverage and reimbursement may impact the demand for, or the price of, any product candidate for which we obtain marketing approval. If coverage and reimbursement are not available or reimbursement is available only to limited levels, we may not be able to successfully commercialize any product candidate for which we obtain marketing approval.

There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved by the FDA or foreign regulatory authorities. Moreover, eligibility for coverage and reimbursement does not imply that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and distribution. Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may only be temporary.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services. Net prices for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that presently restrict imports of drugs from policy and payment limitations in setting their own reimbursement policies. Our inability to ~~promptly obtain~~expand and maintain coverage and profitable reimbursement rates from both government-funded and private payors for ~~any approved~~our products ~~that we develop~~ could have a material adverse effect on our operating results, our ability to raise capital needed to continue to commercialize our products and our overall financial condition.

The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to continue to commercialize our products and affect the prices we may obtain.

The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that may affect our ability to profitably sell our product and product candidates, if approved. The United States government, state legislatures and foreign governments also have shown significant interest in implementing cost-containment programs to limit the growth of government-paid healthcare costs, including price controls, restrictions on reimbursement and requirements for substitution of generic products for branded prescription drugs.

The Affordable Care Act was intended to broaden access to health insurance, reduce or constrain the growth of healthcare spending, enhance remedies against fraud and abuse, add transparency requirements for the healthcare and health insurance industries, impose new taxes and fees on the health industry and impose additional health policy reforms. There have been significant ongoing judicial, administrative, executive and legislative efforts to modify or eliminate the Affordable Care Act, and the Affordable Care Act has also been subject to challenges in the courts. See the section in our Annual Report entitled “Business—Government Regulation—Healthcare Reform.”

Further changes to and under the Affordable Care Act remain possible, although the new Biden administration has signaled that it plans to build on the Affordable Care Act and expand the number of people who are eligible for subsidies under it. President Biden indicated that he intends to use executive orders to undo changes to the Affordable Care Act made by the Trump administration and would advocate for legislation to build on the Affordable Care Act. It is unknown what form any such changes or any law proposed to replace the Affordable Care Act would take, and how or whether it may affect our business in the future. We expect that changes to the Affordable Care Act, the Medicare and Medicaid programs, changes allowing the federal government to directly negotiate drug prices and changes stemming from other healthcare reform measures, especially with regard to healthcare access, financing or other legislation in individual states, could have a material adverse effect on the healthcare industry.

Any reduction in reimbursement from Medicare, Medicaid, or other government programs may result in a similar reduction in payments from private payers. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue and maintain profitability.

Social issues around the abuse of opioids, including law enforcement concerns over diversion of opioids and regulatory and enforcement efforts to combat abuse, could decrease the potential market for ~~Xtampza~~our products and may adversely impact external investor perceptions of our ~~product candidates.~~business.

~~Media stories regarding prescription drug abuse and the diversion of opioids and other controlled substances are commonplace.~~

Law enforcement and regulatory agencies may apply policies and guidelines that seek to limit the availability or use of opioids. Such efforts may inhibit our ability to continue to commercialize ~~Xtampza and~~ our ~~product candidates.~~products.

Aggressive enforcement and unfavorable publicity regarding, for example, the use or misuse of oxycodone or other opioid drugs; the limitations of abuse-resistant formulations; the ability of ~~drug abusers~~people who abuse drugs to discover previously unknown ways to abuse opioid drugs, including ~~Xtampza;~~Xtampza ER and the Nucynta Products; public inquiries and investigations into prescription drug abuse; litigation; or regulatory activity regarding sales, marketing, distribution or storage of opioid drugs could have a material adverse effect on our reputation. Such negative publicity could reduce the potential size of the market for ~~Xtampza and~~ our ~~product candidates and~~products, decrease the revenues we are able to generate from their ~~sale.~~sale and adversely impact external investor perceptions of our business. Similarly, to the extent opioid abuse becomes less prevalent or less urgent of a public health issue, regulators and third party payers may not be willing to pay a premium for abuse-deterrent formulations of ~~opioids.~~opioid.

~~Efforts by the FDA and other regulatory bodies to combat abuse of opioids may negatively impact the market for our product candidates. In February 2016, the FDA released an action plan~~

Federal laws have been enacted to address the national epidemics of prescription opioid abuse ~~epidemic~~ and reassess the FDA’s approach to opioid medications. The plan identifies the FDA’s focus on implementing policies to reverse the opioid abuse epidemic, while maintaining access to effective treatments. The actions set forth in the FDA’s plan include strengthening post marketing study requirements to evaluate the benefit of long-termillicit opioid use, ~~changing~~including the ~~REMS requirements to provide additional funding~~Comprehensive Addiction and Recovery Act and the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for ~~physician education courses, releasing a draft guidance setting forth approval standards for generic-abuse deterrent opioid formulations,~~Patients and ~~seeking input from~~Communities Act. These laws are described in more detail under the FDA’s Science Board to broaden the understanding of the public risks of opioid abuse. The FDA’s Science Board met to address these issues on March 1, 2016. The FDA’s plan is part of a broader initiative led by the HHS to address opioid-related overdose, deathcaption “Business— Governmental Regulation — DEA and dependence. The HHS initiative’s focus is on improving physician’s use of opioids through education and resources to address opioid over-prescribing, increasing use and development of improved delivery systems for naloxone, which can reverse overdose from both prescription opioids and heroin, to reduce overdose-related deaths, and expanding the use of Medication-Assisted Treatment, which couples counseling and behavioral therapies with medication to address substance abuse. Also as part of this initiative, the CDC has launched a state grant program to offer state health departments resources to assist with abuse prevention efforts, including efforts to track opioid prescribing through state-run electronic databases. In March 2016, as part of the HHS initiative, the CDC released a Guideline for Prescribing Opioids for Chronic Pain. The guideline is intended to assist primary care providers treating adults for chronic pain in outpatient settings. The guideline provides recommendations to improve communications between doctors and patients about the risks and benefits of opioid therapy for chronic pain, improve the safety and effectiveness of pain treatment, and reduce the risks associated with long-term opioid therapy. The guideline states that no treatment recommendations about the use of abuse-deterrent opioids can be made at this time. Many of these changes and others could cause us to expend additional resources in developing and commercializing Xtampza and our product candidates to meet additional requirements. Advancements in development and approval of generic abuse-deterrent opioids could also compete with and potentially impact physician use of our product candidates and cause our product candidates to be less commercially successful.Opioid Regulation.”

The FDA continues to evaluate extended release and abuse-deterrent opioids in the postmarket setting. In March 2017, the FDA’s Advisory Committee met to discuss OPANA ER (oxymorphone hydrochloride) extended release tablets. A majority of the Advisory Committee voted that the benefits do not outweigh the risks of OPANA ER. Upon the FDA’s subsequent request in June 2017, OPANA ER was removed from the market. Also, in July 2017, the FDA held a public workshop to discuss available data and methods to assess the impact of opioid formulations with abuse-deterrent properties on misuse, abuse, addiction, overdose, and death in the postmarket context. The FDA will continue to scrutinize the impact of abuse-deterrent opioids and in the future could impose further restrictions to products currently on the market, which may include changing labeling, imposing additional prescribing restrictions, or seeking a product’s removal from the market.

If the FDA or other applicable regulatory authorities approve generic products with abuse deterrent claims that compete with ~~Xtampza or any of~~ our ~~product candidates, it~~products, our sales could ~~reduce our sales.~~decline.

Once an NDA, including a Section 505(b)(2) application, is approved, the product covered thereby becomes a “listed drug” which can, in turn, be cited by potential competitors in support of approval of an ~~abbreviated NDA, or~~ ANDA. The ~~FD&C~~Federal Food, Drug, and Cosmetic Act, FDA regulations and other applicable regulations and policies provide incentives to manufacturers to create modified, non-infringing versions of a drug to facilitate the approval of an ANDA or other application for generic substitutes. These manufacturers might only be required to conduct a relatively inexpensive study to show that their product has the same active ingredients, dosage form, strength, route of administration, and conditions of use, or product labeling, as our product and that the generic product is absorbed in the body at the same rate and to the same extent as, or is bioequivalent to, our product. These generic equivalents would be significantly less costly than ours to bring to market and companies that produce generic equivalents are generally able to offer their products at lower prices. Thus, after the introduction of a generic competitor, a significant percentage of the sales of any branded product are typically lost to the generic product. Accordingly, competition from generic equivalents to our products would substantially limit our ability to generate revenues and therefore to obtain a return on the investments we have made in our ~~product and product candidates.~~products. In November 2017, FDA issued a final guidance to assist industry in the development of generic versions of approved opioids with abuse-deterrent

~~Guidelines and~~47

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formulations, including recommendations ~~published by various organizations can reduce~~about the ~~use~~types of ~~our products, if approved.~~

~~Government agencies promulgate regulations and guidelines directly applicable~~studies that companies should conduct to ~~us and~~demonstrate that the generic drug is no less abuse-deterrent than its brand-name counterpart. In the second half of 2018, the FDA posted three revised product-specific guidances related to generic abuse-deterrent opioid formulations, including one guidance specifically relating to Xtampza ER, which recommend specific in vivo studies and in vitro study considerations for abuse deterrence evaluations. These guidances are part of FDA’s wider focus on assisting developers of generic abuse-deterrent formulations navigate the regulatory path to market more quickly. Earlier market entry of generic abuse-deterrent formulations could have a material adverse effect on our product candidates. In addition, professional societies, practice management groups, private health and science foundations and organizations involved in various diseases from time to time may also publish guidelines or recommendations to the healthcare and patient communities. Recommendations of government agencies or these other groups or organizations may relate to such matters as usage, dosage, route of administration and use of concomitant therapies. Recommendations or guidelines suggesting the reduced use of our products 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 our products.business.

Risks Related to Our Dependence on Third Parties

If the third-party ~~manufacturer~~manufacturers of Xtampza ~~fails~~ER or the Nucynta Products fail to devote sufficient time and resources to ~~Xtampza,~~these products, or ~~its~~their performance is substandard, and/or we encounter challenges with our dedicated facility at our third-party manufacturer’s site for the manufacturing of Xtampza ER, our costs may be higher than expected and could have a material adverse effect on our business.

We do not own any manufacturing facilities ~~and have limited experience~~ in drug development and commercial manufacturing. We currently have no plans to build our own clinical or commercial scale manufacturing ~~facility. We lack~~facility and do not have the resources and expertise to manufacture and test, on a commercial scale, the technical performance of ~~Xtampza and~~ our ~~product candidates.~~products. We currently rely, and expect to continue to rely, on a limited number of experienced personnel and ~~one~~ contract ~~manufacturer~~manufacturers for ~~Xtampza and each product candidate,~~our products, as well as other vendors to formulate, test, supply, store and distribute ~~Xtampza and~~ our ~~product candidates for our clinical trials and FDA registration,~~products, and we control only certain aspects of their activities.

In 2020, we completed the build-out of a dedicated manufacturing suite at a site operated by our contract manufacturing organization, Patheon, part of Thermo Fisher Scientific. This facility requires the maintenance of regulatory approvals and other costs, all of which we will need to absorb. We cannot guarantee that we will be able to leverage the dedicated manufacturing suite in a profitable manner. If the demand for Xtampza ER and any future related products never meets our expectations and forecasts, or if we do not produce the output we plan, we may not be able to realize the return on investment we anticipated, which would have a negative impact on our financial condition and results of operations.

We have initiated the activities required to transition commercial manufacturing for Nucynta ER from Janssen to Patheon, which is an assumed obligation of the Nucynta Commercialization Agreement. We cannot guarantee we will be successful in our efforts to demonstrate equivalence of product manufactured by Patheon with product manufactured by Janssen, and we may encounter delays in obtaining regulatory approval for Patheon as a new manufacturer and supplier of Nucynta ER. Additionally, we may be unsuccessful in validation activities, which could lead to delays in the transfer of manufacturing obligations, higher costs of validation, and/or rejection of otherwise saleable batches of Nucynta ER, all of which could have an adverse effect on our business and results of operations. Even if we are successful in our regulatory approval and validation activities, we could encounter issues in obtaining commercial supply from Patheon's facility due technical problems or challenges obtaining adequate and/or timely DEA procurement quota.

Although we have identified alternate sources for these services, it would be time-consuming, and require us to incur additional cost, to qualify these sources.

Our reliance on a limited number of vendors and, in particular, Patheon as our single manufacturer for Xtampza ER and the future manufacturer of Nucynta ER, exposes us to the following risks, any of which could ~~delay FDA approval of our product candidates and~~impact commercialization of our products, result in higher costs, or deprive us of potential product revenues:

●

Our contract manufacturer, or other third parties we rely on, may encounter difficulties in achieving the volume of production needed to satisfy commercial demand, may experience technical issues that impact quality or compliance with applicable and strictly enforced regulations governing the manufacture of pharmaceutical products, may be affected by natural disasters that interrupt or prevent manufacturing of our products including the ongoing COVID-19 pandemic, may experience shortages of qualified personnel to adequately staff production operations, may experience shortages of raw materials and may have difficulties finding replacement parts or equipment.

●

Our contract manufacturer could default on ~~its~~their agreement with us to meet our requirements for commercial

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supplies of ~~Xtampza.~~

our products and/or we could experience technical problems in the operation of our dedicated manufacturing facility.

●

The use of alternate manufacturers may be difficult because the number of potential manufacturers that have the necessary governmental licenses to produce narcotic products is limited. Additionally, the FDA and the DEA

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must approve any alternative manufacturer of ~~Xtampza or any product candidate for which we receive regulatory approval,~~our products, before we may use the alternative manufacturer to produce commercial supplies.

●

It may be difficult or impossible for us to find a replacement manufacturer on acceptable terms quickly, or at all. Our contract manufacturer and vendors may not perform as agreed or may not remain in the contract manufacturing business for the time required to ~~successfully~~ produce, store and distribute our ~~products.~~

products successfully.

●

If our contract manufacturer were to terminate our arrangement or fail to meet our commercial manufacturing demands, we may be forced to delay our development and commercial programs.

Failure to obtain the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture our products could adversely affect our ability to continue to commercialize the product, which could in turn adversely affect our results of operations and financial condition. Certain components of Xtampza ER are naturally derived products, for which we rely on sole suppliers. The inability of any of our raw material suppliers to provide components that meet our specifications and requirements could adversely impact our ability to manufacture our product. Furthermore, the quota procurement process limits the amount of DEA-controlled active pharmaceutical ingredient we have available for manufacture. Consequently, we are limited in our ability to execute a business strategy that builds appreciable safety stock of finished drug product.

Our reliance on third parties reduces our control over our development and commercialization activities but does not relieve us of our responsibility to ensure compliance with all required legal, regulatory and scientific standards. The FDA and other regulatory authorities require ~~that Xtampza and~~ our ~~product candidates that we may eventually commercialize~~products to be manufactured according to ~~cGMP and similar foreign standards.~~cGMP. Any failure by our third-party manufacturer to comply with cGMP or failure to scale up manufacturing processes, including any failure to deliver sufficient quantities of ~~product candidates~~products in a timely manner, could lead to a ~~delay in, or~~shortage of commercial product. Such failure ~~to obtain, regulatory approval of any of our product candidates. In addition, such failure~~ could also be the basis for the FDA to issue a warning or untitled letter, withdraw approvals for products previously granted to us, or take other regulatory or legal action, including recall or seizure, total or partial suspension of production, suspension of ongoing clinical trials, refusal to approve pending applications or supplemental applications, detention orof product, refusal to permit the import or export of products, injunction, imposing civil penalties or pursuing criminal prosecution.

Any stock out, or failure to obtain sufficient supplies of any of our products, or the necessary active pharmaceutical ingredients, excipients or components necessary to manufacture each of our products, could adversely affect our ability to commercialize such products, which could in turn adversely affect our results of operations and financial condition.

Because we currently rely on a sole supplier to manufacture the active pharmaceutical ingredient of ~~Xtampza,~~our products, any production problems with our supplier could have a material adverse effect on us.

We presently depend upon a single supplier for the active pharmaceutical ingredient for Xtampza ~~— oxycodone base —~~ER (oxycodone base) and the Nucynta Products (tapentadol), and we ~~intend to~~ contract with this supplier ~~as necessary,~~ for commercial supply ofto manufacture our products. Further, our sole supplier also supplies our primary competitor in the extended-release oxycodone space, Purdue. Although we have identified an alternate source for oxycodone base for Xtampza ER, it would be time-consuming and costly to qualify this source. ~~Since we currently obtain our active ingredient from this manufacturer on a purchase-order basis, either we or~~Any changes that our supplier ~~may terminate~~makes to the respective drug substance raw materials, intermediates, or manufacturing processes would introduce technical and regulatory risks to our ~~arrangement, without cause, at any time without notice.~~downstream drug product supply. If our supplier were to terminate ~~our~~an arrangement for an active pharmaceutical ingredient, or fail to meet our supply needs (including as a result of disruptions in personnel or the global supply chain resulting from the COVID-19 outbreak), we might incur substantial costs and be forced to delay our development or commercialization programs. Any such delay could have a material adverse effect on our business.

We rely on third parties to conduct our clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or if they terminate their agreement with us, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could suffer a material adverse effect.

We have relied upon and plan to continue to rely upon contract research organizations, or CROs, to monitor and manage data for our ongoing preclinical and clinical programs. We rely on these parties for execution of our clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and clinical trials are 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 federal regulations and current Good Clinical Practices, or GCP, which are international standards meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, advisors and monitors, enforced by the FDA, the Competent Authorities of the Member States of the European Economic Area, or EEA, and foreign regulatory authorities in the form of International Conference on Harmonization, or ICH, guidelines for all of our product candidates in clinical development. Regulatory authorities enforce these GCP through periodic inspections of trial sponsors, principal investigators and trial sites. In addition, we and our CROs are required to comply with special regulations regarding the enrollment of recreational drug abusers in clinical trials. If we or any of our CROs fail to comply with applicable GCP and other regulations, including as a result of any recent changes in such regulations, the

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clinical data generated in our clinical trials may be deemed unreliable and the FDA or foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials comply with GCP requirements. In addition, our clinical trials must be conducted with product produced under cGMP requirements. While we have agreements governing activities of our CROs, we have limited influence over their actual performance. Failure to comply with applicable regulations in the conduct of the clinical trials for our product candidates may require us to repeat preclinical studies and clinical trials, which would delay the regulatory approval process.

Our CROs are not our employees, and except for remedies available to us under our agreements with such CROs, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and preclinical programs. If CROs do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for 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, the commercial prospects for our product candidates would be harmed, our costs could increase substantially and our ability to generate revenue could be delayed.

Switching or adding additional CROs involves additional cost and requires management time and focus, and there is a limited number of CROs that are equipped and willing to manage clinical trials that involve recreational drug abusers. Our CROs have the right to terminate their agreements with us in the event of an uncured material breach. In addition, some of our CROs have an ability to terminate their respective agreements with us if it can be reasonably demonstrated that the safety of the patients participating in our clinical trials warrants such termination, if we make a general assignment for the benefit of our creditors or if we are liquidated. Identifying, qualifying and managing performance of third-party service providers can be difficult, time-consuming and cause delays in our development programs. In addition, there is a natural transition period when a new CRO commences work and the new CRO may not provide the same type or level of services as the original provider. Though we carefully manage our relationships with our CROs, there can be no assurance that we will not encounter challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects. If any of our relationships with our CROs terminate, we may not be able to enter into arrangements with alternative CROs or to do so on commercially reasonable terms. As a result, delays may occur, which can materially impact our ability to meet our desired clinical development timelines.

Our internal capacity to perform these functions is limited. Outsourcing these functions involves risks that third parties may not perform to our standards, may not produce results in a timely manner or may fail to perform at all. In addition, the use of third-party service providers requires us to disclose our proprietary information to these parties, which could increase the risk that this information will be misappropriated. We currently have a small number of employees, which limits the internal resources we have available to identify and monitor our third-party providers. To the extent, we are unable to identify and successfully manage the performance of third-party service providers in the future, our ability to advance our product candidates through clinical trials will be compromised. There can be no assurance that we will not encounter similar challenges or delays in the future or that these delays or challenges will not have a material adverse impact on our business, financial condition and prospects.

In the future, we may depend on collaborations with third parties for the development and commercialization of Xtampza and our product candidates. If those collaborations are not successful, we may not be able to capitalize on the market potential of these product candidates.

We may not be successful in establishing development and commercialization collaborations which could adversely affect, and potentially prohibit, our ability to develop or commercialize Xtampza and our product candidates. These collaborations, including our license agreement for the development and marketing of Onsolis, pose the following risks to us:

~~Collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations.~~

~~Collaborators may not pursue development and commercialization of our product or product candidates or may~~

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elect not to continue or renew development or commercialization programs based on clinical trial results, changes in the collaborator’s strategic focus or available funding or external factors such as an acquisition that diverts resources or creates competing priorities.

Collaborators may delay clinical trials, provide insufficient funding for a clinical trial program, stop a clinical trial or abandon our product or product candidate, repeat or conduct new clinical trials or require a new formulation of our product or product candidate for clinical testing.

Collaborators may conduct clinical trials inappropriately, or may obtain unfavorable results in their clinical trials, which may have an adverse effect on the development or commercialization of our product or product candidates.

Collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our product or product candidates if the collaborators believe that competitive products are more likely to be successfully developed or can be commercialized under terms that are more economically attractive than ours.

~~A collaborator with marketing and distribution rights to one or more products may not commit sufficient resources to the marketing and distribution of such products.~~

Collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our proprietary information or expose us to potential litigation.

Disputes may arise between the collaborators and us that result in the delay or termination of the research, development or commercialization of our product and product candidates or that result in costly litigation or arbitration that diverts management attention and resources.

~~We may lose certain valuable rights under circumstances specified in our collaborations.~~

~~Collaborations may be terminated and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable product or product candidates.~~

Collaboration agreements may not lead to development or commercialization of products or product candidates in the most efficient manner or at all. If a future collaborator of ours were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished or terminated.

~~We may rely on collaborators to market and commercialize Xtampza and, if approved, our product candidates, who may fail to effectively commercialize our products.~~

We may utilize strategic collaborators or contract sales forces, where appropriate, to assist in the commercialization of Xtampza and our product candidates, if approved by the FDA. We currently possess limited resources and may not be successful in establishing collaborations or co-promotion arrangements on acceptable terms, if at all. We also face competition in our search for collaborators and co-promoters. If we enter into strategic collaborations or similar arrangements, we will rely on third parties for financial resources and for development, commercialization, sales and marketing and regulatory expertise. Our collaborators, if any, may fail to develop or effectively commercialize our products and product candidates because they cannot obtain the necessary regulatory approvals, they lack adequate financial or other resources or they decide to focus on other initiatives. Any failure of our third-party collaborators to successfully market and commercialize our product and product candidates would diminish our revenues.

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Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or limit commercial supply.

In our current commercial manufacturing operations, and as we scale up manufacturing of our products ~~and product candidates~~ and conduct required stability testing, we may encounter product, packaging, equipment and process-related issues that may require refinement or resolution in order to proceed with our planned clinical trials, obtain regulatory approval for commercial marketing and build commercial supplies. In the future, we may identify impurities, which could result in increased scrutiny by regulatory authorities, delays in our clinical programs and regulatory approval, increases in our operating expenses, failure to obtain or maintain approval or limitations in our commercial supply.

~~Our customer concentration~~

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We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors, that loss may materially adversely affect our financial condition and results of operations.

A significant percentage of our product shipments are to a limited number of independent wholesale ~~drug~~pharmaceutical distributors. Three of our wholesale pharmaceutical distributors represented 35%, ~~28%~~31% and ~~27%~~31% of our product shipments for the ~~year~~nine months ended ~~December 31, 2016. If we were to lose the business~~September 30, 2021. Our loss of ~~one or more of these distributors, or if~~ any of these ~~distributors failed~~wholesale pharmaceutical distributors’ accounts, or a material reduction in their purchases, a significant disruption to ~~fulfill their obligations~~transportation infrastructure or ~~refused or experienced difficulty in paying us on~~other means of distribution of our products, including as a ~~timely basis, or negotiated larger discounts, it would~~result of the ongoing COVID-19 outbreak, could have a material adverse effect on our business, results of operations, financial condition and prospects. The significance of each wholesale pharmaceutical distributor account to our business adversely impacts our ability to negotiate favorable commercial terms with each such distributor, and as a result, we may be forced to accept terms that adversely impact our results of operations.

In addition, these wholesale customers comprise a significant part of the distribution network for pharmaceutical products in the United States. This distribution network has undergone, and may continue to undergo, significant consolidation marked by mergers and acquisitions. As a result, a small number of large wholesale distributors control a significant share of the market. Consolidation of drug wholesalers has increased, and may continue to increase, competitive and pricing pressures on pharmaceutical products. We cannot guarantee that we can manage these pricing pressures or that wholesaler purchases will not fluctuate unexpectedly from period to period.

Our products could be subject to post-marketing requirements, which requirements may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control.

Our products are subject to a comprehensive regulatory scheme, including post-marketing requirements (“PMRs”) to conduct epidemiological studies and clinical trials. We intend to fulfill our PMRs by virtue of our participation in the Opioid PMR Consortium (“OPC”). Although we retain discretion in how to discharge such PMRs, the scale and scope of the studies required by the FDA make it cost prohibitive to discharge these requirements other than by joining the OPC that was formed to conduct them. We are a member of OPC and engage in decision-making as a member of that organization, but do not have a majority. If the OPC fails to conduct sufficiently rigorous studies or is unable to achieve the patient enrollment or other requirements established by the FDA, we may be unable to satisfy our PMRs and the FDA may choose to withdraw or otherwise restrict its approval of our products. Such withdrawal or restriction would have an adverse impact on our business and financial condition.

We rely on third parties to conduct our non-clinical and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, or if they terminate their agreement with us, we may not be able to maintain regulatory approval for our products and our business could suffer a material adverse effect.

We have relied upon and plan to continue to rely upon contract research organizations (“CROs”) to monitor and manage data for any non-clinical and clinical programs that we may conduct, including the OPC PMR studies discussed above. We rely on these parties for execution of our non-clinical and clinical trials, and control only certain aspects of their activities. Nevertheless, we are responsible for ensuring that each of our studies and clinical trials are 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. If we or any of our CROs fail to comply with applicable GCP and other regulations, including as a result of any recent changes in such regulations, the clinical data generated in our clinical trials may be deemed unreliable and the FDA or foreign regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. In addition, our clinical trials must be conducted with product produced under cGMP requirements. While we have agreements governing the activities of our CROs, we have limited influence over their actual performance. Failure to comply with applicable regulations in the conduct of the clinical trials for our products would have an adverse impact on our commercial efforts.

Risks Related to Our Business and Strategy

Our business may be adversely affected by the COVID-19 pandemic.

The outbreak and any preventative or protective actions that we, our manufacturers, suppliers, licensors and other collaborators or governmental authorities may take with respect to the COVID-19 pandemic have disrupted and may

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continue to disrupt our business and the U.S. and global economies as a whole. The COVID-19 pandemic poses the risk that we or our employees, contractors, suppliers, and other partners may be prevented from conducting business activities for an indefinite period of time, including due to a substantial percentage of personnel contracting the virus or due to shutdowns that have been or may be requested or mandated by governmental authorities. The full extent to which the COVID-19 pandemic will affect the U.S. and global economies is unknown.

The COVID-19 pandemic has, and will likely continue to have, a substantial impact on the delivery of healthcare services in the United States. Healthcare providers have reduced staffing and limited access for non-patients, including our sales professionals. Notwithstanding the lifting of COVID-19 restrictions in many jurisdictions, and amidst continuing public health concerns relating to the spread of COVID-19, weekly pain patient office visits continue to be depressed compared to pre-COVID periods, which in turn may account for fewer patients beginning therapy with our products. We believe that the disruptions caused by COVID-19 will continue and there remains substantial uncertainty as to when such disruptions will cease. These circumstances may result in reduced demand for our products and negatively impact our sales and results of operations.

The extent to which the COVID-19 pandemic continues to impact our results of operation will depend on future developments, which are highly uncertain and cannot be predicted, including new information which may emerge concerning the severity of COVID-19, the rate and manner in which it spreads, the duration of the pandemic, travel restrictions imposed by the United States and other countries, business closures or business disruption in the United States and other countries, a reduction in time spent out of home and the actions taken throughout the world, including in our markets, to contain COVID-19 or treat its impact. Although travel and other restrictions have been lifted in certain jurisdictions, there remains substantial uncertainty as to the possibility of further surges in infections, including surges resulting from the development of new variants of COVID-19, such as the Delta variant, which could lead to travel and other restrictions being re-imposed. These actions could have a material adverse impact on our business, financial condition and results of operations, and we will continue to monitor the effects of the COVID-19 pandemic closely.

Litigation or regulatory action regarding opioid medications could negatively affect our business.

Beginning in 2018, lawsuits alleging damages related to opioids have been filed naming us as a defendant along with other manufacturers of prescription opioid medications. These lawsuits, filed in multiple jurisdictions, are brought by various local governments as well as private claimants, against various manufacturers, distributors and retail pharmacies. These lawsuits generally contend that we have engaged in improper marketing practices related to Xtampza ER and the Nucynta Products. Plaintiffs seek a variety of remedies, including abatement, restitution, civil penalties, disgorgement of profits, treble damages, attorneys’ fees and injunctive relief. Some plaintiffs have alleged joint and several liability among the defendants, meaning that any given defendant may be found liable for the activities of other defendants. None of the complaints specify the exact amount of damages at issue. These cases are generally in early stages of litigation.

In addition, certain governmental and regulatory agencies are focused on the abuse of opioid medications, a concern we share, and we have received Civil Investigative Demands or subpoenas from four state attorneys general investigating our sales and marketing of opioids and seeking documents relating to the manufacture, marketing and sale of opioid medications. We are cooperating fully in these investigations. Managing litigation and responding to governmental investigations is costly and may involve a significant diversion of management attention. Such proceedings are unpredictable and may develop over lengthy periods of time. An adverse resolution of any of these lawsuits or investigations may involve injunctive relief or substantial monetary penalties, either or both of which could have a material adverse effect on our reputation, business, results of operations and cash flows.

~~Risks Related to Our Business and Strategy~~

We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products ~~before or~~ more successfully than we do.

~~The biopharmaceutical industry is intensely competitive and subject to rapid and significant technological change. In addition, the competition~~

Competition in the pain and opioid market is intense. ~~We have~~Our competitors ~~both in the United States and internationally, including~~include major multinational pharmaceutical companies, biotechnology companies and universities and other research institutions.

~~We face and will continue to face competition from other companies in the pharmaceutical and medical device industries. Xtampza and our product candidates, if approved, will~~ Our products compete with ~~currently marketed~~ oral opioids, transdermal opioids, local anesthetic patches, stimulants and implantable and external infusion pumps that can be used for infusion of opioids and local anesthetics. Products of these types are marketed by Actavis, ~~Depomed, Egalet,~~BioDelivery Sciences, Endo, Mallinckrodt, ~~Pernix, Pfizer,~~ Purdue, Teva, and others. Some of these current and potential future competitors may be addressing the same therapeutic areas or indications as we are. Many of our current and potential future competitors have significantly greater research and development capabilities than we do, have substantially more marketing, manufacturing, financial, technical, human and managerial resources than we do, and have more institutional experience than we do. ~~Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated in our competitors.~~

As a result of these factors, our competitors may obtain regulatory approval of their products more rapidly than we are able to or may obtain patent protection or other intellectual property rights that allow them to develop and commercialize their products before us and limit our ability to develop or commercialize our product and product candidates. Our competitors may also develop drugs that are safer, more effective, more widely used and less costly than ours, and they may also be more successful than us in manufacturing and marketing their products.

Furthermore, if the FDA approves a competitor’s 505(b)(2) application for a drug candidate before our application for a similar drug candidate and grants the competitor a period of exclusivity, the FDA may take the position that it cannot approve our NDA for a similar drug candidate. For example, several competitors have developed extended-release hydrocodone products, and if the FDA grants exclusivity, we could be subject to a delay that would dramatically reduce the expected market penetration for our hydrocodone product candidate. Additionally, even if our 505(b)(2) application is approved for marketing, we may still be subject to competition from other hydrocodone products, including approved products or other approved 505(b)(2) NDAs for different conditions of use that would not be restricted by any grant of exclusivity to us.

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~~In addition,~~ competitors have developed or ~~are in the process of developing~~may develop technologies that are, or ~~in the future~~ may be, the basis for competitive ~~products. Some~~

Table of ~~these products may have an entirely different approach or means of accomplishing similar therapeutic effects than our product candidates. Our competitors may develop~~ Contents

products that are safer, more effective or less costly than our ~~product candidates and, therefore, present a serious competitive threat to our product offerings.~~

The widespread acceptance of currently available therapies with which our product and product candidates, if approved, compete may limit market acceptance of our product and product candidates even if commercialized. Oralproducts. Moreover, oral medications, transdermal drug delivery systems, such as drug patches, injectable products and implantable drug delivery devices are currently available treatments for chronic pain, are widely accepted in the medical community and have a long history of use. These treatments will compete with our ~~product and product candidates, if approved,~~products and the established use of these competitive products may limit the potential for our ~~product and product candidates~~products to receive widespread ~~acceptance if commercialized.~~acceptance.

The use of legal and regulatory strategies by competitors with innovator products, including the filing of citizen petitions, may delay or prevent the introduction or approval of our product candidates, increase our costs associated with the introduction or marketing

Commercial sales of our products, ~~or significantly reduce the profit potential~~and clinical trials of our products and any future product candidates,.

~~Companies with innovator drugs often pursue strategies that~~ may ~~serve~~expose us to ~~prevent or delay competition from alternatives to their innovator products. These strategies include, but are not limited to:~~

~~filing “citizen petitions” with the FDA that may delay competition by causing delays of our product approvals;~~

~~seeking to establish regulatory~~expensive product liability claims, and ~~legal obstacles that would make it more difficult to demonstrate a product’s bioequivalence or “sameness” to the related innovator product;~~

~~filing suits for patent infringement that automatically delay FDA approval of products seeking approval based on the Section 505(b)(2) pathway;~~

~~obtaining extensions of market exclusivity by conducting clinical trials of innovator drugs in pediatric populations or by other methods;~~

persuading the FDA to withdraw the approval of innovator drugs for which the patents are about to expire, thus allowing the innovator company to develop and launch new patented products serving as substitutes for the withdrawn products;

~~seeking to obtain new patents on drugs for which patent protection is about to expire; and~~

~~initiating legislative and administrative efforts in various states to limit the substitution of innovator products by pharmacies.~~

~~These strategies could delay, reduce or eliminate our entry into the market and our ability to generate revenues from our product and product candidates.~~

~~Our future success depends on our ability to retain our key personnel.~~

We are highly dependent upon the services of our key personnel, including our President and Chief Executive Officer, Michael T. Heffernan, our Chief Financial Officer, Paul Brannelly, our Chief Operating Officer, Joseph Ciaffoni and our Chief Technology Officer, Alison Fleming, PhD. Each employee is employed by us at will and is permitted to terminate his or her employment with us at any time pursuant to the terms of his employment agreement. We do not maintain “key person” insurance for any of our executives or other employees. The loss of the services of Mr. Heffernan, Mr.

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~~Brannelly, Mr. Ciaffoni or Dr. Fleming could impede the achievement of our development and commercialization objectives.~~

~~If we are unable to attract and retain highly qualified scientific and technical employees,~~ we may not be able to ~~grow effectively.~~maintain product liability insurance on reasonable terms or at all.

Our future growth and success depend on our ability to recruit, retain, manage and motivate our scientific, clinical, manufacturing and commercial employees. The loss of any member of our senior management team or the inability to hire or retain experienced management personnel could compromise our ability to execute our business plan and harm our operating results. Because of the specialized scientific nature of our business, we rely heavily on our ability to attract and retain qualified personnel. The competition for qualified personnel in the pharmaceutical field is intense, and as a result, we

We currently carry product liability insurance. Product liability claims may be ~~unable to continue to attract and retain qualified personnel necessary for the development of~~brought against us by patients; clinical trial participants; healthcare providers; or others using, administering or selling our ~~business or to recruit suitable replacement personnel.~~

~~We will need to grow the size of~~products. If we cannot successfully defend ourselves against claims that our ~~organization, and~~products caused injuries, we ~~may experience difficulties in managing this growth.~~

~~We have experienced a period of rapid growth. Our management, personnel and systems may not be adequate to support this and future growth.~~could incur substantial liabilities. We may not be able to ~~effectively manage the expansion~~maintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Regardless of ~~our operations, which~~merit or eventual outcome, liability claims may result in weaknesses in our infrastructure, give rise to operational mistakes, loss of business opportunities, loss of employees and reduced productivity among remaining employees. Future growth could require significant capital expenditures and may divert financial resources from other projects, such as the development of our existing or future product candidates. Future growth would impose significant added responsibilities on members of management, including:

~~managing the commercialization of any FDA-approved products;~~

~~overseeing clinical trials effectively;~~

identifying, recruiting, maintaining, motivating and integrating additional employees, including any sales and marketing personnel engaged in connection with the commercialization of any approved product;

~~managing our internal development efforts effectively while complying with our contractual obligations to licensors, licensees, contractors and other third parties;~~

~~improving our managerial, development, operational and financial systems and procedures; and~~

~~developing our compliance infrastructure and processes to ensure compliance with regulations applicable to public companies.~~

As our operations expand, we will need to manage additional relationships with various strategic collaborators, suppliers and other third parties. Our future financial performance and our ability to commercialize our product and product candidates and to compete effectively will depend, in part, on our ability to manage any future growth effectively. To that end, we must be able to manage our development efforts and clinical trials effectively and hire, train and integrate additional management, administrative and sales and marketing personnel. We may not be able to accomplish these tasks, and our failure to accomplish any of them could prevent us from successfully growing our company.

We may acquire other assets or businesses, or form collaborations or make investments in other companies or technologies, that could have a material adverse effect on our operating results, dilute our shareholders’ ownership, increase our debt or cause us to incur significant ~~expense.~~costs to defend the litigation.

As part of our business strategy, we may pursue acquisitions of assets, including preclinical, clinical or commercial stage products or product candidates, or businesses, in-licensing or out-licensing of products, product candidates or technologies, or other strategic alliances and collaborations, to expand our existing technologies and operations. We may not identify or complete these transactions in a timely manner, on a cost-effective basis, or at all, and we may not realize

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the anticipated benefits of any such transaction, any of which could have a material adverse effect on our financial condition, results of operations and cash flows. We have limited experience with acquiring other companies, products or product candidates, and limited experience with licensing and forming strategic alliances and collaborations. We may not find suitable acquisition candidates, and if we make an acquisition, we may not integrate the acquisition successfully into our existing business and we may incur additional debt or assume unknown or contingent liabilities in connection therewith. Integration of an acquired company or assets may also disrupt ongoing operations, require the hiring of additional personnel and the implementation of additional internal systems and infrastructure, especially the acquisition of commercial assets, and require management resources that would otherwise focus on developing our existing business. We may not be able to find suitable strategic alliance or collaborators or identify other investment opportunities, and we may experience losses related to any such investments.

To finance any acquisitions, licenses or collaborations, we may incur significant transaction expenses and we may choose to issue debt or shares of our common or preferred stock as consideration. Any such issuance of shares would dilute the ownership of our shareholders. If the price of our common stock is low or volatile, we may not be able to acquire, license, or otherwise obtain rights to other assets or companies or fund a transaction using our stock as consideration. Alternatively, it may be necessary for us to raise additional funds for acquisitions through public or private financings. Additional funds may not be available on terms that are favorable to us, or at all.

Our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements, which could cause significant liability for us and harm our reputation.

We are exposed to the risk that our employees, independent contractors, principal investigators, CROs, consultants and vendors may engage in fraudulent conduct or other illegal activity. Misconduct by these parties could include intentional, reckless and/or negligent conduct or disclosure of unauthorized activities to us that violates:

~~FDA, DEA or similar regulations of foreign regulatory authorities, including those laws requiring the reporting of true, complete and accurate information to such authorities;~~

~~manufacturing standards;~~

~~federal and state healthcare fraud and abuse laws and regulations and similar laws and regulations established and enforced by foreign regulatory authorities; or~~

~~laws that require the reporting of financial information or data accurately.~~

In particular, sales, marketing and business arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Activities subject to these laws also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to our reputation. We have adopted a Code of Ethics, but it is not always possible to identify and deter misconduct by employees and other third parties, and the precautions we take to detect and prevent this activity 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 such laws or regulations. If any such actions are instituted against us, and we are not successful in defending ourselves or asserting our rights, those actions could have a material adverse effect on our business and results of operations, including the imposition of civil, criminal and administrative penalties, damages, monetary fines, 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 have a material adverse effect on our ability to operate our business and our results of operations.

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Our relationships with customers and payors are subject to applicable anti-kickback, fraud and abuse, transparency, and other healthcare laws and regulations, which could expose us to criminal sanctions, civil penalties, exclusion from government healthcare programs, contractual damages, reputational harm, administrative burdens, and diminished profits and future earnings.

Healthcare providers, physicians and payors play a primary role in the recommendation and prescription of ~~Xtampza and any product candidates for which we may obtain marketing approval.~~our products. Our ~~future~~ arrangements with payors and customers may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which we market, sell and distribute ~~Xtampza~~our products and any product candidates for which we may obtain marketing approval. Even though we do not and will not control referrals of healthcare services or bill ~~directly to~~ Medicare, Medicaid or other third-party payors ~~federal~~directly, we may provide reimbursement guidance and support regarding our products to our customers and patients. Federal and state healthcare laws and regulations pertaining to fraud and abuse and patients’ rights are and will be applicable to our business. ~~Restrictions under applicable federal, state and foreign healthcare laws and regulations may affect our ability to operate and expose us to areas of risk, including:~~

the federal Anti-Kickback Statute, which prohibits, among other things, knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal and state healthcare programs such as Medicare and Medicaid. A person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation;

the federal False Claims Act, which imposes criminal and civil penalties, including through civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government. In addition, the government may assert that a claim including items and services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the False Claims Act;

the federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute to defraud any healthcare benefit program or specific intent to violate it in order to have committed a violation;

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and its implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

federal laws requiring drug manufacturers to report annually information related to certain payments and other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals, as well as ownership or investment interests held by physicians and their immediate family members, including under the federal Open Payments program, commonly known as the Sunshine Act, as well as other state and foreign laws regulating marketing activities and requiring manufacturers to report marketing expenditures, payments and other transfers of value to physicians and other healthcare providers;

federal government price reporting laws, which require us to calculate and report complex pricing metrics to government programs, where such reported prices may be used in the calculation of reimbursement and/or discounts on our marketed drugs. Participation in these programs and compliance with the applicable requirements may subject us to potentially significant discounts on our products, increased infrastructure costs, potential liability for the failure to report such prices in an accurate and timely manner, and potentially limit our

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~~ability to offer certain marketplace discounts; and~~

state and foreign equivalents of each of the above laws, including state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental payors, including private insurers; state laws which require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restricting payments that may be made to healthcare providers; and state and foreign laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

While we do not submit claims and our customers will make the ultimate decision on how to submit claims, we may provide reimbursement guidance and support regarding our products to our customers and patients. If a government authority were to conclude that we provided improper advice to our customers and/or encouraged the submission of false claims for reimbursement, we could face action by government authorities. Efforts to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations will involve substantial costs. Nonetheless, it is possible that governmental authorities will conclude that our business practices may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If our operations are found to be in violation of any of these laws or any other governmental regulations that may apply to us, we may be subject to significant civil, criminal and administrative penalties, damages, fines, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, and the curtailment or restructuring of our operations.

We or the third parties upon whom we ~~fail to comply with environmental,~~depend may be adversely affected by natural disasters and/or health ~~and safety laws and regulations, we could become subject to fines or penalties or incur significant costs.~~

~~In connection with our research and development activities~~epidemics, and our ~~manufacture~~business continuity and disaster recovery plans may not adequately protect us from a serious disaster.

Natural disasters could severely disrupt our operations, and have a material adverse effect on our business, results of ~~materials~~operations, financial condition and ~~products~~prospects. If a natural disaster, power outage, health epidemic (such as the ongoing COVID-19 pandemic) or other event occurred that prevented us from using all or a significant portion of our facilities, that damaged critical infrastructure, such as the manufacturing facilities of our third-party contract manufacturers, or that otherwise disrupted operations, it might become difficult or, in certain cases, impossible for us to continue our business, and ~~product candidates,~~any disruption could last for a substantial period of time.

The disaster recovery and business continuity plans we ~~are subject to federal, state~~have in place, and ~~local laws, rules, regulations and policies governing~~ the ~~use, generation, manufacture, storage, air emission, effluent discharge, handling and disposal of certain materials, biological specimens and wastes. Although we believe~~technology that we ~~have complied with the applicable laws, regulations and policies in all material respects and have not been required~~may rely upon to ~~correct any material noncompliance, we~~implement such plans, may be required to incur significant costs to comply with environmental and health and safety regulations in the future. Current or future laws and regulations may impair our research, development or production efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.

Our research and development involves the use, generation and disposal of hazardous materials, including chemicals, solvents, agents and biohazardous materials. Although we believe that our safety procedures for storing, handling and disposing of such materials comply with the standards prescribed by state and federal regulations, we cannot completely eliminate the risk of accidental contamination or injury from these materials. We currently contract with third parties to dispose of these substances that we generate, and we rely on these third parties to properly dispose of these substances in compliance with applicable laws and regulations. We cannot eliminate the risk of contamination or injury from these materials. If these third parties do not properly dispose of these substances in compliance with applicable laws and regulations, we may be subject to legal action by governmental agencies or private parties for improper disposal of these substances. The costs of defending such actions and the potential liability resulting from such actions are often very large. In the event we are subject to such legal action or we otherwise fail to comply with applicable laws and regulations governing the use, generation and disposal of hazardous materials and chemicals, we could be held liable for any damages that result, and any such liability could exceed our resources.

Although we maintain workers’ compensation insurance to cover us for costs and expenses we may incur due to injuries to our employees, this insurance may not provide adequate coverage against potential liabilities. We maintain insurance for environmental liability or toxic tort claims, but we may not continue to maintain such insurance in the future, and such insurance, to the extent maintained, may not be adequate to cover liabilities that may be asserted against us in connection with our storage or disposal of biological, hazardous or radioactive materials.

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~~Our business and operations would suffer~~prove inadequate in the event of ~~computer system failures, accidents~~a serious disaster or ~~security breaches.~~

~~Despite~~similar event. We may incur substantial expenses as a result of the ~~implementation of security measures, our internal computer systems, and those~~limited nature of our ~~CROs, contract manufacturing organization, or CMO,~~disaster recovery and ~~other third parties on~~business continuity plans, which we rely, are vulnerable to damage from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. System failures, accidents or security breaches could ~~cause interruptions in our operations, and could result in~~have a material ~~disruption~~adverse effect on our business, financial condition and results of our commercial and clinical activities and business operations, in addition to possibly requiring substantial expenditures of resources to remedy. If such an event were to occur and cause interruptions in our operations, it could result in a material disruption of our commercialization and drug development programs. For example, the loss of clinical trial data from completed or ongoing clinical trials could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any disruption or security breach was to result in a loss of or damage to our data or applications, or inappropriate disclosure of confidential or proprietary information, we could incur liability and the further development of our product candidates could be delayed.operation.

Risks Related to Our Common Stock

The price of our common stock may be volatile and you may lose all or part of your investment.

The market price of our common stock is highly volatile and may be subject to wide fluctuations in response to numerous factors described in these Risk Factors, some of which are beyond our control. ~~In addition to the factors discussed in these Risk Factors, these factors include:~~

~~the success of competitive products or technologies;~~

~~regulatory actions with respect to our product and product candidates or our competitors’ products or product candidates;~~

~~actual or anticipated changes in our growth rate relative to our competitors;~~

~~the outcome of any patent infringement or other litigation that may be brought against us, including the ongoing Purdue litigation;~~

~~announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;~~

~~results of clinical trials of our product and product candidates or those of our competitors;~~

~~regulatory or legal developments in the United States and other countries;~~

~~developments or disputes concerning patent applications, issued patents or other proprietary rights;~~

~~the recruitment or departure of key personnel;~~

~~the level of expenses related to our product and product candidates or clinical development programs;~~

~~actual or anticipated variations in our quarterly operating results;~~

~~the number and characteristics of our efforts to in-license or acquire additional product candidates or products;~~

~~introduction of new products or services by us or our competitors;~~

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~~failure to meet the estimates and projections of the investment community or that we may otherwise provide to the public;~~

~~actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;~~

~~variations in our financial results or those of companies that are perceived to be similar to us;~~

~~fluctuations in the valuation of companies perceived by investors to be comparable to us;~~

~~share price and volume fluctuations attributable to inconsistent trading volume levels of our shares;~~

~~announcement or expectation of additional financing efforts;~~

~~sales of our common stock by us, our insiders or our other shareholders;~~

~~changes in accounting practices;~~

~~significant lawsuits, including patent or shareholder litigation;~~

~~changes in the structure of healthcare payment systems;~~

~~market conditions in the pharmaceutical and biotechnology sectors;~~

~~general economic, industry and market conditions;~~

~~publication of research reports about us, our competitors or our industry, or positive or negative recommendations or withdrawal of research coverage by securities or industry analysts; and~~

~~other events or factors, many of which are beyond our control.~~

~~In addition, the~~The stock market in general, and pharmaceutical and biotechnology companies in particular, have experienced extreme price and volume ~~fluctuations that have often been unrelated or disproportionate to the operating performance~~fluctuations.

Table of ~~these companies.~~ Contents

Broad market and industry factors may negatively affect the market price of our common stock, regardless of our business model, prospects or actual operating performance. The realization of any of ~~the above~~these risks, or any of a broad range of other risks ~~stated above~~discussed in this report, could have a material adverse effect on the market price of our common stock.

As we operate in the pharmaceutical and biotechnology industry, we are especially vulnerable to these factors to the extent that they affect our industry or our products. In the past, securities class action litigation has often been initiated against companies following periods of volatility in their stock price. This type of litigation could result in substantial costs and divert our management’s attention and resources, and could also require us to make substantial payments to satisfy judgments or to settle litigation.

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

Sales of a substantial number of shares of our common stock in the public market could occur at any time. These sales, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of our common stock. As of December 31, 2016, holders of an aggregate of approximately 6.3 million shares of our common stock have rights, subject to certain conditions, to require us to file registration statements covering their shares or to include their shares in registration statements that we may file for ourselves or other shareholders. Once we register these shares, they can be freely sold in the public market, subject to volume limitations applicable to affiliates.

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Actual or potential sales of our common stock by our directors or employees, including our executive officers, pursuant to pre-arranged stock trading plans could cause our stock price to fall or prevent it from increasing for numerous reasons, and actual or potential sales by such persons could be viewed negatively by investors.

In accordance with the guidelines specified under Rule 10b5-1 of the Exchange Act and our policies regarding stock transactions, our directors and employees, including our executive officers, could adopt stock trading plans pursuant to which they may sell shares of our common stock from time to time in the future. Generally, sales under such plans by our executive officers and directors require public filings. Actual or potential sales of our common stock by such persons could cause our common stock to fall or prevent it from increasing for numerous reasons. For example, a substantial number of shares of our common stock becoming available (or being perceived to become available) for sale in the public market could cause the market price of our common stock to fall or prevent it from increasing. Also, actual or potential sales by such persons could be viewed negatively by investors.

Future issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans, could result in additional dilution of the percentage ownership of our shareholders and could cause our stock price to fall.

We expect that significant additional capital will be needed in the future to continue our planned operations. To raise capital, we may sell substantial amounts of common stock or securities convertible into or exchangeable for common stock. These future issuances of common stock or common stock-related securities, together with the exercise of outstanding options and any additional shares issued in connection with acquisitions, if any, may result in material dilution to our investors. Such sales may also result in material dilution to our existing shareholders, and new investors could gain rights, preferences and privileges senior to those of holders of our common stock.

~~Our principal shareholders and management own a majority of our stock and have the ability to exert significant control over matters subject to shareholder approval.~~

As of December 31, 2016, our executive officers, directors, holders of 5% or more of our capital stock and their respective affiliates beneficially owned a majority of our voting stock, including shares subject to outstanding options and warrants. As a result, if these shareholders were to choose to act together, they would be able to significantly influence the outcome of all matters requiring shareholder approval, including the election of directors, amendments of our organizational documents, or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for our common stock that you may feel are in your best interest. The interests of this group of shareholders may not always coincide with your interests or the interests of other shareholders and they may act in a manner that advances their best interests and not necessarily those of other shareholders, including seeking a premium value for their common stock, and might affect the prevailing market price for our common stock. Such concentration of ownership control may:

~~delay, defer or prevent a change in control;~~

~~entrench our management and/or the board of directors; or~~

~~impede a merger, consolidation, takeover or other business combination involving us that other shareholders may desire.~~

In addition, persons associated with Longitude Capital Partners, LLC and Skyline Venture Partners V, L.P. currently serve on our board of directors. The interests of Longitude Capital Partners, LLC and Skyline Venture Partners V, L.P. may not always coincide with the interests of the other shareholders, and the concentration of control in Longitude Capital Partners, LLC and Skyline Venture Partners V, L.P. limits other shareholders’ ability to influence corporate matters. We may also take actions that our other shareholders do not view as beneficial, which may adversely affect our results of operations and financial condition and cause a decline in our stock price.

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We are subject to anti-takeover provisions in our second amended and restated articles of incorporation and amended and restated bylaws and under Virginia law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our shareholders.

Certain provisions of Virginia law, the state in which we are incorporated, and our second amended and restated articles of incorporation and amended and restated bylaws could hamper a third party’s acquisition of us, or discourage a third party from attempting to acquire control of us. These provisions ~~include:~~

a provision allowing our board of directors to set the terms of and issue preferred stock with rights senior to those of the common stock without any vote or action by the holders of our common stock. The issuance of preferred stock could adversely affect the rights and powers, including voting rights, of the holders of common stock;

~~advance written notice procedures and notice requirements with respect to shareholder proposals and shareholder nomination of candidates for election as directors;~~

~~a provision that only the board of directors, the chairman of the board of directors or the president may call a special meeting of the shareholders;~~

the application of Virginia law prohibiting us from entering into certain transactions with the beneficial owner of more than 10 percent of our outstanding voting stock for a period of three years after such person first reached that level of stock ownership, unless certain conditions are met;

~~a provision dividing our board of directors into three classes, each serving three-year terms;~~

~~the requirement that the authorized number of our directors be changed only by resolution of our board of directors;~~

~~a provision that our board of directors shall fill any vacancies on our board of directors, including vacancies resulting from a board of directors’ resolution to increase the number of directors;~~

~~limitations on the manner in which shareholders can remove directors from the board of directors;~~

~~the lack of cumulative voting in the election of directors; and~~

~~the prohibition on shareholders acting by less-than-unanimous written consent.~~

~~These provisions also~~ could limit the price that certain investors might be willing to pay in the future for shares of our common stock. In addition, these provisions make it more difficult for our shareholders to remove our ~~board~~Board of ~~directors~~Directors or management or elect new directors to our ~~board~~Board of ~~directors.~~Directors.

~~We may fail to qualify for continued listing on The NASDAQ Global Select Market which could make it more difficult for investors to sell their shares.~~

Our common stock is listed on The NASDAQ Global Select Market (“NASDAQ”). As a NASDAQ listed company, we are required to satisfy the continued listing requirements of NASDAQ for inclusion in the Global Select Market to maintain such listing, including, among other things, the maintenance of a minimum closing bid price of $1.00 per share and shareholders’ equity of at least $10.0 million. There can be no assurance that we will be able to maintain compliance with the continued listing requirements or that our common stock will not be delisted from NASDAQ in the future. If our common stock is delisted by NASDAQ, we could face significant material adverse consequences, including:

~~a limited availability of market quotations for our securities;~~

~~reduced liquidity with respect to our securities;~~

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a determination that our shares are a “penny stock,” which will require brokers trading in our shares to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares;

~~a limited amount of news and analyst coverage for our company; and~~

~~a decreased ability to issue additional securities or obtain additional financing in the future.~~

~~If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.~~

The trading market for our common stock depends in part on the research and reports that securities or industry analysts publish about us or our business. If one or more of the analysts who cover us downgrade our stock or publish inaccurate or unfavorable research about our business, our stock price would likely decline. If one or more of these analysts cease coverage of our company or fail to publish reports on us regularly, demand for our stock could decrease, which might cause our stock price and trading volume to decline.

We are an “emerging growth company” and we intend to take advantage of reduced disclosure and governance requirements applicable to emerging growth companies, which could result in our common stock being less attractive to investors and we cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make our shares of common stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act, and may remain an emerging growth company for up to five years. For so long as we remain an emerging growth company, we are permitted and intend to rely on certain exemptions from various reporting requirements applicable to other public companies, but not to emerging growth companies, including, but not limited to, an exemption from the auditor attestation requirement of Section 404 of the Sarbanes-Oxley Act, reduced disclosure about executive compensation arrangements pursuant to the rules applicable to smaller reporting companies and no requirement to seek non-binding advisory votes on executive compensation or golden parachute arrangements. We will remain an emerging growth company until the earliest of (i) December 31, 2020, (ii) the first fiscal year after our annual gross revenue are $1.07 billion or more, (iii) the date on which we have, during the previous three-year period, issued more than $1.0 billion in non-convertible debt securities or (iv) the end of any fiscal year in which the market value of our common stock held by non-affiliates exceeded $700 million as of the end of the second quarter of that fiscal year.

In addition, Section 107 of the JOBS Act also provides that an emerging growth company can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act for complying with new or revised accounting standards. An emerging growth company can therefore delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. However, we are choosing to “opt out” of such extended transition period and, as a result, we will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies. Section 107 of the JOBS Act provides that our decision to opt out of the extended transition period for complying with new or revised accounting standards is irrevocable.

We cannot predict if investors will find our common stock less attractive as a result of our taking advantage of these exemptions. If some investors find our common stock less attractive as a result of our choices, there may be a less active trading market for our common stock and our stock price may be more volatile.

If investors find our common stock less attractive as a result of our reduced reporting requirements, there may be a less active trading market for our common stock and our stock price may be more volatile. We may also be unable to raise additional capital as and when we need it.

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If we fail to maintain an effective system of internal control over financial reporting, we may not be able to ~~accurately~~ report our financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us and, as a result, the value of our common stock.

The Sarbanes-Oxley Act requires, among other things, that we maintain effective internal control over financial reporting. ~~Commencing with our annual report on Form 10-K for the year ended December 31, 2016, we~~We are required, under Section 404 of the Sarbanes-Oxley Act, to furnish a report by management on, among other things, the effectiveness of our internal control over financial reporting. This assessment must include disclosure of any material weaknesses identified by our management in our internal control over financial reporting. A material weakness is a control deficiency, or combination of control deficiencies, in internal control over financial reporting that results in more than a reasonable possibility that a material misstatement of annual or interim financial statements will not be prevented or detected on a timely basis. Section 404 of the Sarbanes-Oxley Act also generally requires an attestation from our independent registered public accounting firm on the effectiveness of our internal control over financial reporting. However, for as long as we remain an emerging growth company as defined in the JOBS Act, we intend to take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the independent registered public accounting firm attestation requirement.

Our compliance with Section 404 will require that we incur substantial accounting expense and expend significant management efforts. We currently do not have an internal audit group, and we will need to hire additional accounting and financial staff with appropriate public company experience and technical accounting knowledge, and compile the system and process documentation necessary to perform the evaluation needed to comply with Section 404. We may not be able to complete our evaluation, testing and any required remediation in a timely fashion, which could potentially subject us to sanctions or investigations by the SEC or other regulatory authorities. During the evaluation and testing process, ifIf we identify one or more material weaknesses in our internal control over financial reporting, we will be unable to assert that our internal control over financial reporting is effective. We cannot assure you that there will not be material weaknesses or significant deficiencies in our internal control over financial reporting in the future. Any failure to maintain internal control over financial reporting could severely inhibit our ability to accurately report our financial condition, results of operations or cash flows. If we are unable to conclude that our internal control over financial reporting is effective, or if our independent registered public accounting firm determines we have a material weakness or significant deficiency in our internal control over financial reporting once that firm begin its reviews,Further, we could lose investor confidence in the accuracy and completeness of our financial reports, the market price of our common stock could decline, and we could be subject to sanctions or investigations by NASDAQ, the SEC or other regulatory authorities. Failure to remedy any material weakness in our internal control over financial reporting, or to implement or maintain other effective control systems required of public companies, could also restrict our future access to ~~the~~ capital markets.

~~Our disclosure controls and procedures may not prevent or detect all errors or acts~~

Sales of ~~fraud.~~

~~We are subject to~~our common stock in the ~~periodic reporting requirements of the Exchange Act. Our disclosure controls and procedures are designed to reasonably assure that information required to be disclosed~~public market, either by us ~~in reports we file~~ or ~~submit under~~by our current shareholders, or the ~~Exchange Act is accumulated and communicated to management, recorded, processed, summarized and reported within the time periods specified~~perception that these sales could occur, could cause a decline in the ~~rules and forms~~market price of the SEC. We believe that any disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.

These inherent limitations reflect the reality that judgments can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in our ~~control system, misstatements due to error or fraud may occur and not be detected.~~

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~~The~~securities. Moreover, the exercise of options and warrants and other issuances of shares of common stock or securities convertible into or exercisable for shares of common stock will dilute your ownership interests and may adversely affect the future market price of our common stock.

Sales of our common stock in the public market, either by us or by our current shareholders, or the perception that these sales could occur, could cause a decline in the market price of our securities. All of the shares of our common stock held by ~~those of~~ our current shareholders may be immediately eligible for resale in the open market either in compliance with an exemption under Rule 144 promulgated under the Securities Act, or pursuant to an effective resale registration statement that we have previously filed with the SEC. Such sales, along with any other market transactions, could adversely affect the market price of our common stock.

~~In addition, as~~

As of September 30, ~~2017,~~2021, there were ~~(a)~~ outstanding options to purchase an aggregate of ~~3,056,954~~3,078,247 shares of our common stock at a weighted average exercise price of ~~$13.00~~$18.37 per share, of which options to purchase ~~940,101~~2,326,929 shares of our common stock were then ~~exercisable, and (b) 2,445~~exercisable. In addition, as of September 30, 2021, we had an outstanding warrant to purchase 1,041,667 shares of ~~common stock issuable upon the exercise of warrants to purchase~~our common stock at ~~a weighted-average~~an exercise price of ~~$12.27~~$19.20 per share. The exercise of options and warrants at prices below the market price of our common stock could adversely affect the price of shares of our common stock. Additional dilution may result from the issuance of shares of our common stock in connection with collaborations or manufacturing arrangements or in connection with other financing efforts.

~~Any issuance of our common stock~~There can be no assurance that ~~is not made solely to then-existing shareholders proportionate to their interests, such as in the case of a stock dividend or stock split,~~we will result in dilution to each shareholder by reducing his, her or its percentage ownership of the total outstanding shares. Moreover, if we issue options or warrants to purchase our common stock in the future and those options or warrants are exercised you may experience further dilution. Holders ofrepurchase shares of our common stock ~~have no preemptive rights~~at all, or that ~~entitle them~~we will repurchase shares at favorable prices.

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In August 2021, our board of directors authorized a share repurchase program to ~~purchase their pro rata share of any offering of shares of any class or series.~~

~~We have broad discretion in the use of our cash and cash equivalents, and, despite our efforts, we may use them in a manner that does not increase the value of your investment.~~

We have broad discretion in the use of our cash and cash equivalents, and investors must rely on the judgment of our management regarding the use of our cash and cash equivalents. Our management may not use cash and cash equivalents in ways that ultimately increase the valuerepurchase up to $100 million of our common ~~stock. Our failure to use~~stock (of which $82.5 million remained available as of September 30, 2021). Any share repurchases will depend upon, among other factors, our cash balances and ~~cash equivalents effectively could result in~~potential future capital requirements, our results of operations and financial ~~losses that could have a material adverse effect on our business, cause~~condition, the price of our common stock on the NASDAQ Global Select Market, and other factors that we may deem relevant. We can provide no assurance that we will continue to ~~decline and delay the commercialization or development~~repurchase shares of our ~~product and product candidates. We may invest our cash and cash equivalents in short-term or long-term, investment-grade, interest-bearing securities. These investments may not yield~~Common Stock at favorable returns. If we do not invest or apply our cash and cash equivalents in ways that enhance shareholder value, we may fail to achieve expected financial results, which could cause the price of our common stock to decline.prices, if at all.

~~Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain.~~

We have never declared or paid cash dividends on our common stock. We currently intend to retain all of our future earnings, if any, to finance the growth and development of our business and do not anticipate declaring or paying any cash dividends for the foreseeable future. In addition, the terms of any future debt agreements may preclude us from paying dividends. As a result, capital appreciation, if any, of our capital stock will be your sole source of gain for the foreseeable future.

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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

RECENT SALES OF UNREGISTERED SECURITIES

There were no unregistered sales of equity securities during the period covered by this Quarterly Report on Form 10-Q.

PURCHASE OF EQUITY SECURITIES

The following table sets forth ~~purchases~~shares of Common Stock repurchased under our ~~common stock for the three months ended September 30, 2017:~~

Period
(a) Total number of shares purchased (1)
(b) Average Price Paid per Share
(c) Total number of shares purchased as part of publicly announced plans or programs
(d) Maximum number of shares that may yet be purchased under the plans or programs
July 1, 2017 through July 31, 2017
1,403
12.39
-
-
August 1, 2017 through August 31, 2017
-
-
-
-
September 1, 2017 through September 30, 2017
-
-
-
-
Total
1,403
$ 12.39
-
-

~~(1) All of the~~Repurchase Program, as well as shares ~~were~~ transferred to us from employees in satisfaction of minimum tax withholding obligations associated with the vesting of performance share units and restricted stock units during the ~~period.~~three months ended September 30, 2021. Amounts are reflected in thousands, except share and per share amounts.


Period	(a) Total number of shares purchased		(b) Average Price Paid per Share		(c) Total number of shares purchased as part of publicly announced plans or programs ⁽¹⁾		(d) Maximum approximate dollar value of Shares that may yet be purchased under the plans or programs
July 1, 2021 through July 31, 2021	1,989		$	23.74	—		100,000
August 1, 2021 through August 31, 2021	426,645		$	20.62	418,205		91,363
September 1, 2021 through September 30, 2021	441,585		$	20.06	440,835		82,520
Total	870,219	⁽²⁾	$	20.34	859,040	⁽²⁾

(1)

The Repurchase Program was announced on August 16, 2021. The Repurchase Program provides for the repurchase of up to $100 million of outstanding shares of our common stock at any time or times through December 31, 2022. The Repurchase Program did not expire during the three months ended September 30, 2021, nor does the Company currently plan to terminate the Repurchase Program prior to expiration. However, there can be no assurance as to the timing or number of shares of any repurchases in the future.

(2)

The difference between the total number of shares purchased and the total number of shares purchased as part of a publicly announced program relates to common stock withheld by us for employees to satisfy their tax withholding obligations arising upon the vesting of performance share units and restricted stock units granted under our Amended and Restated 2014 Stock Incentive Plan.

Item 3. Defaults Upon Senior Securities.

None.

Item 4. Mine Safety Disclosures.

Not applicable.

Item 5. Other Information.

Not applicable.

Item 6. Exhibits.

~~See the Exhibit Index on the following page of this Quarterly Report on Form 10-Q.~~

~~EXHIBIT INDEX~~

Exhibit Number		Exhibit Description

31.1



~~31.1~~		Certification of Chief Executive Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
31.2		Certification of Chief Financial Officer pursuant to Rules 13a- 14(a) or 15d-14(a) of the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).
32.1		Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
32.2		Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (furnished herewith).
101.INS		Inline XBRL Instance Document
101.SCH		Inline XBRL Taxonomy Extension Schema Document
101.CAL		Inline XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF		Inline XBRL Taxonomy Extension Definition Linkbase Document
101.LAB		Inline XBRL Taxonomy Extension Label Linkbase Document
101.PRE		Inline XBRL Taxonomy Extension Presentation Linkbase Document
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

+Indicates management contract or compensatory plan.

~~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.


				COLLEGIUM PHARMACEUTICAL, INC.
	~~COLLEGIUM PHARMACEUTICAL, INC.~~

Date:	November ~~8, 2017~~4, 2021		By:	/s/ ~~MICHAEL HEFFERNAN~~JOSEPH CIAFFONI
		~~Michael Heffernan~~		Joseph Ciaffoni
				Chief Executive Officer
				(Principal executive officer)

Date:	November ~~8, 2017~~4, 2021		By:	/s/ ~~PAUL BRANNELLY~~COLLEEN TUPPER
		~~Paul Brannelly~~		Colleen Tupper
				Chief Financial Officer
				(Principal financial and accounting officer)

	PART I—FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (Unaudited)	4
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	17 29
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	23
~~Item 4.~~	~~Controls and Procedures~~	23

	~~PART II—OTHER INFORMATION~~
		37
Item 1.4.	~~Legal Proceedings~~Controls and Procedures	25 37

	PART II—OTHER INFORMATION

Item ~~1A.~~1.	~~Risk Factors~~Legal Proceedings	25 39
Item 2.1A.	Risk Factors	39
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	65 54
Item 3.	Defaults Upon Senior Securities	65 54
Item 4.	Mine Safety Disclosures	65 54
Item 5.	Other Information	65 54
Item 6.	Exhibits	66 55
Signature		56




	September 30,		December 31,
	2017		2016
Assets
Current assets
Cash and cash equivalents	$	107,611	$	153,225
Accounts receivable		5,823		2,129
Inventory		1,401		1,316
Prepaid expenses and other current assets		4,061		1,905
Total current assets		118,896		158,575
Property and equipment, net		1,632		1,038
Intangible assets, net		1,877		2,103
Restricted cash		97		97
Other long-term assets		171		204
Total assets	$	122,673	$	162,017
Liabilities and shareholders' equity (deficit)
Current liabilities
Accounts payable	$	4,982	$	9,106
Accrued expenses		19,268		8,879
Deferred revenue		—		4,944
Current portion of term loan payable		2,146		2,667
Total current liabilities		26,396		25,596
Lease incentive obligation		8		34
Term loan payable, long-term		—		1,479
Total liabilities		26,404		27,109
Commitments and contingencies (see Note 10)
Shareholders’ equity:
Preferred stock, $0.001 par value; authorized shares - 5,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - none at September 30, 2017 and December 31, 2016		—		—
Common stock, $0.001 par value; authorized shares - 100,000,000 at September 30, 2017 and December 31, 2016; issued and outstanding shares - 30,765,100 at September 30, 2017 and 29,364,100 at December 31, 2016		31		29
Additional paid-in capital		376,884		358,063
Accumulated deficit		(280,646)		(223,184)
Total shareholders’ equity		96,269		134,908
Total liabilities and shareholders’ equity	$	122,673	$	162,017


						Significant
				Quoted Prices		other		Significant
				in active		observable		unobservable
				markets		inputs		inputs
Description		Total		(Level 1)		(Level 2)		(Level 3)
September 30, 2017
Money market funds, included in cash equivalents	$	81,026	$	81,026	$	—	$	—

December 31, 2016
Money market funds, included in cash equivalents	$	125,515	$	125,515	$	—	$	—


				Additional				Total
	Common Stock			Paid- In		Accumulated		Shareholders’
	Shares		Amount	Capital		Deficit		Equity (Deficit)
Balance, December 31, 2016	29,364,100	$	29	$	358,063	$	(223,184)	$	134,908
Exercise of common stock options	131,755		1		427		—		428
Issuance for employee stock purchase plan	110,841		—		1,141		—		1,141
Vesting of restricted stock units	14,757		—		—		—		—
Shares withheld for employee taxes upon vesting of restricted stock units	(4,819)		—		(68)		—		(68)
Issuance of common stock resulting from at-the-market transactions, net of issuance costs of $507	1,148,466		1		11,454		—		11,455
Stock-based compensation	—		—		5,867		—		5,867
Net loss	—		—		—		(57,462)		(57,462)
Balance, September 30, 2017	30,765,100	$	31	$	376,884	$	(280,646)	$	96,269



	Three months ended				Nine months ended
	September 30,				September 30,
	2017		2016		2017		2016
Research and development expenses	$	222	$	171	$	673	$	474
Selling, general and administrative expenses		1,878		1,470		5,194		3,663
Total stock-based compensation expense	$	2,100	$	1,641	$	5,867	$	4,137


		Weighted-Average
		Purchase Price
	Shares	per Share
Unvested at December 31, 2016	43,265	$	5.73
Granted	—		—
Vested	(24,336)		5.73
Unvested at September 30, 2017 (1)	18,929	$	5.73


		Weighted-Average
	Shares	Grant Date Fair Value
Outstanding at December 31, 2016	41,741	$	16.15
Granted	211,018		12.45
Settled	(14,757)		16.15
Forfeited	(19,130)		15.52
Outstanding at September 30, 2017	218,872	$	12.64


				Weighted-
			Weighted-	Average
			Average	Remaining		Aggregate
			Exercise Price	Contractual		Intrinsic
	Shares		per Share	Term (in years)		Value
Outstanding at December 31, 2016	2,326,801	$	13.07	8.7	$	7,927
Granted	1,261,373		12.06
Exercised	(131,755)		3.25
Cancelled	(399,465)		13.62
Outstanding at September 30, 2017	3,056,954	$	13.00	8.6	$	3,604
Exercisable at September 30, 2017	940,101	$	12.80	7.8	$	1,727
Vested and expected to vest at September 30, 2017	2,909,114	$	13.08	8.5	$	3,571


Period	(a) Total number of shares purchased (1)	(b) Average Price Paid per Share	(c) Total number of shares purchased as part of publicly announced plans or programs	(d) Maximum number of shares that may yet be purchased under the plans or programs
July 1, 2017 through July 31, 2017	1,403	12.39	-	-
August 1, 2017 through August 31, 2017	-	-	-	-
September 1, 2017 through September 30, 2017	-	-	-	-
Total	1,403	$ 12.39	-	-