UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

 

FORM 10-Q

 

(Mark One)

 

 

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

 

For the quarterly period ended June 30, 2020March 31, 2021

OR

 

 

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: 001-38529

 

Verrica Pharmaceuticals Inc.

(Exact Name of Registrant as Specified in its Charter)

 

 

Delaware

46-3137900

(State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

10 North High44 West Gay Street, Suite 200400

West Chester, PA

19380

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (484) 453-3300

10 North High Street, Suite 200

West Chester, Pa 19380

(Former address of principal executive offices)

 

 

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, $0.0001 par value

 

VRCA

 

The Nasdaq Stock Market LLC

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

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

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

 

Large accelerated filer

 

  

Accelerated filer

 

 

 

 

 

Non-accelerated filer

 

  

Smaller reporting company

 

 

 

 

 

 

 

 

Emerging growth company

 

 

 

 

 

 

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

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

 

As of July 30, 2020,May 3, 2021, the registrant had 25,814,49327,409,576 shares of common stock, $0.0001 par value per share, outstanding.

 

 

 


 

VERRICA PHARMACEUTICALS INC.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

 

PART I. FINANCIAL INFORMATION

Item 1.

 

Financial Statements (Unaudited)

 

1

 

 

 

 

 

Item 2.

 

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

 

1415

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risks

 

2123

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

2223

 

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

23

 

 

 

 

 

Item 1A.

 

Risk Factors

 

23

 

 

 

 

 

Item 2.

 

Recent Sales of Unregistered Securities and Use of Proceeds

 

25

 

 

 

 

 

Item 3.

 

Defaults Upon Senior Securities

 

25

 

 

 

 

 

Item 4.

 

Mine Safety Disclosures

 

25

 

 

 

 

 

Item 5.

 

Other Information

 

25

 

 

 

 

 

Item 6.

 

Exhibits

 

25

 

 

 

 

 

Signatures

 

27

 

 

 


PART I. FINANCIAL INFORMATION

 

Item 1.

Unaudited Condensed Financial Statements

VERRICA PHARMACEUTICALS INC.

CONDENSED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

48,932

 

 

$

9,241

 

 

$

44,101

 

 

$

10,686

 

Marketable securities

 

 

30,690

 

 

 

52,776

 

 

 

43,585

 

 

 

54,784

 

License receivable

 

 

11,500

 

 

 

 

Prepaid expenses and other assets

 

 

3,716

 

 

 

2,966

 

 

 

2,860

 

 

 

2,180

 

Total current assets

 

 

83,338

 

 

 

64,983

 

 

 

102,046

 

 

 

67,650

 

Property and equipment, net

 

 

2,517

 

 

 

2,090

 

 

 

3,329

 

 

 

3,102

 

Operating lease right-of-use asset

 

 

 

 

 

111

 

 

 

1,780

 

 

 

1,836

 

Other non-current assets

 

 

1,381

 

 

 

1,240

 

 

 

947

 

 

 

1,566

 

Total assets

 

$

87,236

 

 

$

68,424

 

 

$

108,102

 

 

$

74,154

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accounts payable

 

$

1,297

 

 

$

1,185

 

 

$

878

 

 

$

348

 

Accrued expenses and other current liabilities

 

 

2,557

 

 

 

2,036

 

 

 

2,881

 

 

 

3,114

 

Operating lease liability

 

 

124

 

 

 

130

 

 

 

230

 

 

 

198

 

Deferred revenue

 

 

 

 

 

500

 

Current debt, net

 

 

34,720

 

 

 

 

 

 

40,669

 

 

 

35,315

 

Total current liabilities

 

 

38,698

 

 

 

3,351

 

 

 

44,658

 

 

 

39,475

 

Operating lease liability

 

 

 

 

 

58

 

 

 

1,634

 

 

 

1,693

 

Other liabilities

 

 

75

 

 

 

 

Total liabilities

 

 

38,773

 

 

 

3,409

 

 

 

46,292

 

 

 

41,168

 

Commitments and Contingencies (Note 10)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 0 shares

issued and outstanding as of June 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 authorized;

25,919,637 shares issued and 25,814,493 shares outstanding as of June 30, 2020 and

25,912,137 shares issued and 25,786,330 shares outstanding as of December 31, 2019

 

 

3

 

 

 

3

 

Treasury stock, at cost, 105,144 shares as of June 30, 2020 and

December 31, 2019

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; 0 shares

issued and outstanding as of March 31, 2021 and December 31, 2020

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 authorized;

27,595,864 shares issued and 27,490,720 shares outstanding as of March 31, 2021 and

25,546,257 shares issued and 25,441,113 shares outstanding as of December 31, 2020

 

 

3

 

 

 

3

 

Treasury stock, at cost, 105,144 shares as of March 31, 2021 and

December 31, 2020

 

 

0

 

 

 

0

 

Additional paid-in capital

 

 

128,851

 

 

 

126,594

 

 

 

166,626

 

 

 

136,868

 

Subscription receivable

 

 

 

 

 

(410

)

Accumulated deficit

 

 

(80,423

)

 

 

(61,192

)

 

 

(104,822

)

 

 

(103,886

)

Accumulated other comprehensive gain

 

 

32

 

 

 

20

 

 

 

3

 

 

 

1

 

Total stockholders’ equity

 

 

48,463

 

 

 

65,015

 

 

 

61,810

 

 

 

32,986

 

Total liabilities and stockholders’ equity

 

$

87,236

 

 

$

68,424

 

 

$

108,102

 

 

$

74,154

 

 

The accompanying notes are an integral part of these condensed financial statements.

1


VERRICA PHARMACEUTICALS INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

For the Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

 

 

 

 

 

 

 

 

License revenue

 

$

12,000

 

 

$

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

3,521

 

 

$

3,928

 

 

$

8,413

 

 

$

8,415

 

 

 

5,362

 

 

 

4,892

 

General and administrative

 

 

5,110

 

 

 

3,593

 

 

 

10,098

 

 

 

7,132

 

 

 

6,578

 

 

 

4,988

 

Total operating expenses

 

 

8,631

 

 

 

7,521

 

 

 

18,511

 

 

 

15,547

 

 

 

11,940

 

 

 

9,880

 

Loss from operations

 

 

(8,631

)

 

 

(7,521

)

 

 

(18,511

)

 

 

(15,547

)

Income (loss) from operations

 

 

60

 

 

 

(9,880

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

126

 

 

 

523

 

 

 

404

 

 

 

1,070

 

 

 

32

 

 

 

278

 

Interest expense

 

 

(904

)

 

 

 

 

 

(1,124

)

 

 

 

 

 

(1,028

)

 

 

(220

)

Other expense

 

 

 

 

 

(3

)

 

 

 

 

 

(3

)

Total other (expense) income

 

 

(778

)

 

 

520

 

 

 

(720

)

 

 

1,067

 

 

 

(996

)

 

 

58

 

Net loss

 

$

(9,409

)

 

$

(7,001

)

 

$

(19,231

)

 

$

(14,480

)

 

$

(936

)

 

$

(9,822

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.38

)

 

$

(0.28

)

 

$

(0.77

)

 

$

(0.58

)

 

$

(0.04

)

 

$

(0.39

)

Weighted average common shares outstanding, basic and diluted

 

 

24,965,634

 

 

 

24,875,573

 

 

 

24,964,900

 

 

 

24,866,721

 

 

 

25,602,404

 

 

 

24,964,167

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(9,409

)

 

$

(7,001

)

 

$

(19,231

)

 

$

(14,480

)

 

$

(936

)

 

$

(9,822

)

Other comprehensive gain:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Unrealized gain on marketable securities

 

 

12

 

 

 

27

 

 

 

12

 

 

 

55

 

 

 

2

 

 

 

 

Comprehensive loss

 

$

(9,397

)

 

$

(6,974

)

 

$

(19,219

)

 

$

(14,425

)

 

$

(934

)

 

$

(9,822

)

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

2



VERRICA PHARMACEUTICALS INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

(in thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Accumulated

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

Total

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other

 

 

Total

 

 

Common Stock

 

 

Additional

 

 

Subscription

 

 

Accumulated

 

 

Treasury Stock

 

 

Comprehensive

 

 

Stockholders’

 

 

Shares Issued

 

 

Amount

 

 

Paid-in Capital

 

 

Receivable

 

 

Deficit

 

 

Shares

 

 

Cost

 

 

Gain (Loss)

 

 

Equity

 

January 1, 2021

 

 

25,546,257

 

 

$

3

 

 

$

136,868

 

 

$

 

 

$

(103,886

)

 

 

105,144

 

 

$

 

 

$

1

 

 

$

32,986

 

Issuance of common stock net of issuance costs

 

 

2,033,899

 

 

 

 

 

 

28,115

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

28,115

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,403

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,403

 

Exercise of stock options

 

 

15,708

 

 

 

 

 

 

240

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

240

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(936

)

 

 

 

 

 

 

 

 

 

 

 

(936

)

Unrealized loss on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2

 

 

 

2

 

March 31, 2021

 

 

27,595,864

 

 

$

3

 

 

$

166,626

 

 

$

 

 

$

(104,822

)

 

 

105,144

 

 

$

 

 

$

3

 

 

 

61,810

 

 

Common Stock

 

 

Additional

 

 

Subscription

 

 

Accumulated

 

 

Treasury Stock

 

 

Comprehensive

 

 

Stockholders’

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Shares Issued

 

 

Amount

 

 

Paid-in Capital

 

 

Receivable

 

 

Deficit

 

 

Shares

 

 

Cost

 

 

Gain (Loss)

 

 

Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 1, 2020

 

 

25,912,137

 

 

$

3

 

 

$

126,594

 

 

$

(410

)

 

$

(61,192

)

 

 

105,144

 

 

$

 

 

$

20

 

 

$

65,015

 

 

 

25,912,137

 

 

$

3

 

 

$

126,594

 

 

$

(410

)

 

$

(61,192

)

 

 

105,144

 

 

$

 

 

$

20

 

 

$

65,015

 

Repayment of subscription receivable

 

 

 

 

 

 

 

 

 

 

 

410

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

410

 

 

 

 

 

 

 

 

 

 

 

 

410

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

410

 

Stock-based compensation

 

 

 

 

 

 

 

 

998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

998

 

 

 

 

 

 

 

 

 

998

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

998

 

Exercise of stock options

 

 

7,500

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 

 

7,500

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,822

)

 

 

 

 

 

 

 

 

 

 

 

(9,822

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,822

)

 

 

 

 

 

 

 

 

 

 

 

(9,822

)

March 31, 2020

 

 

25,919,637

 

 

 

3

 

 

 

127,599

 

 

 

 

 

 

(71,014

)

 

 

105,144

 

 

 

 

 

 

20

 

 

 

56,608

 

 

 

25,919,637

 

 

$

3

 

 

$

127,599

 

 

$

 

 

$

(71,014

)

 

 

105,144

 

 

$

 

 

$

20

 

 

 

56,608

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,252

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,252

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(9,409

)

 

 

 

 

 

 

 

 

 

 

 

(9,409

)

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

12

 

 

 

12

 

June 30, 2020

 

 

25,919,637

 

 

$

3

 

 

$

128,851

 

 

$

 

 

$

(80,423

)

 

 

105,144

 

 

$

 

 

$

32

 

 

$

48,463

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

January 1, 2019

 

 

25,809,900

 

 

$

3

 

 

$

122,526

 

 

$

 

 

$

(33,083

)

 

 

105,144

 

 

$

 

 

$

(17

)

 

$

89,429

 

Stock-based compensation

 

 

 

 

 

 

 

 

780

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

780

 

Exercise of stock options

 

 

3,729

 

 

 

 

 

 

3

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,479

)

 

 

 

 

 

 

 

 

 

 

 

(7,479

)

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

28

 

 

 

28

 

Adoption of ASU 2018-07 (See Note 2)

 

 

 

 

 

 

 

 

(98

)

 

 

 

 

 

98

 

 

 

 

 

 

 

 

 

 

 

 

 

March 31, 2019

 

 

25,813,629

 

 

 

3

 

 

 

123,211

 

 

 

 

 

 

(40,464

)

 

 

105,144

 

 

 

-

 

 

 

11

 

 

 

82,761

 

Stock-based compensation

 

 

 

 

 

 

 

 

846

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

846

 

Exercise of stock options

 

 

31,812

 

 

 

 

 

 

212

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

212

 

Unrealized gain on marketable securities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

27

 

 

 

27

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(7,001

)

 

 

 

 

 

 

 

 

 

 

 

(7,001

)

June 30, 2019

 

 

25,845,441

 

 

$

3

 

 

$

124,269

 

 

$

 

 

$

(47,465

)

 

 

105,144

 

 

$

 

 

$

38

 

 

$

76,845

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

3



VERRICA PHARMACEUTICALS INC.

CONDENSED STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

For the Six Months Ended June 30,

 

 

For the Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(19,231

)

 

$

(14,480

)

 

$

(936

)

 

$

(9,822

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

2,250

 

 

 

1,626

 

 

 

1,403

 

 

 

998

 

Accretion of discounts on marketable securities

 

 

(121

)

 

 

(642

)

 

 

(14

)

 

 

(93

)

Depreciation expense

 

 

26

 

 

 

22

 

 

 

11

 

 

 

14

 

Non cash interest expense

 

 

328

 

 

 

 

 

 

393

 

 

 

65

 

Reduction in operating lease right-of-use asset

 

 

111

 

 

59

 

 

 

56

 

 

66

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

License receivable

 

 

(11,500

)

 

 

 

Prepaid expenses and other assets

 

 

(709

)

 

 

358

 

 

 

13

 

 

 

701

 

Accounts payable

 

 

112

 

 

 

33

 

 

 

525

 

 

 

(82

)

Accrued expenses and other current liabilities

 

 

798

 

 

 

1,147

 

 

 

(209

)

 

 

279

 

Accounts payable and accrued expenses - related party

 

 

 

 

 

(32

)

Deferred revenue

 

 

(500

)

 

 

 

Operating lease liability

 

 

(64

)

 

 

(58

)

 

 

(27

)

 

 

(32

)

Net cash used in operating activities

 

 

(16,500

)

 

 

(11,967

)

 

 

(10,785

)

 

 

(7,906

)

Cash flows from investing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales and maturities of marketable securities

 

 

44,355

 

 

 

70,565

 

 

 

20,500

 

 

 

24,355

 

Purchases of marketable securities

 

 

(22,136

)

 

 

(49,232

)

 

 

(9,285

)

 

 

(5,382

)

Purchases of property and equipment

 

 

(815

)

 

 

 

 

 

(311

)

 

 

(699

)

Deposits

 

 

(69

)

 

 

 

Net cash provided by investing activities

 

 

21,404

 

 

 

21,333

 

 

 

10,835

 

 

 

18,274

 

Cash flows from financing activities

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

7

 

 

 

215

 

 

 

240

 

 

 

7

 

Proceeds from issuance of debt, net

 

 

34,460

 

 

 

 

 

 

4,975

 

 

 

34,460

 

Debt issuance costs

 

 

(90

)

 

 

 

 

Proceeds from issuance of common stock, net of issuance costs

 

 

28,150

 

 

 

 

Repayment of subscription receivable

 

 

410

 

 

 

 

 

 

 

 

 

410

 

Net cash provided by financing activities

 

 

34,787

 

 

 

215

 

 

 

33,365

 

 

 

34,877

 

Net increase in cash and cash equivalents

 

 

39,691

 

 

 

9,581

 

 

 

33,415

 

 

 

45,245

 

Cash and cash equivalents at the beginning of the period

 

 

9,241

 

 

 

10,271

 

 

 

10,686

 

 

 

9,241

 

Cash and cash equivalents at the end of the period

 

$

48,932

 

 

$

19,852

 

 

$

44,101

 

 

$

54,486

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Supplemental disclosure of noncash investing and financing activities:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Property and equipment purchases payable or accrued at period end

 

$

429

 

 

$

534

 

 

$

253

 

 

$

333

 

Debt issuance costs accrued at period end

 

$

25

 

 

$

 

Change in unrealized gain on marketable securities

 

$

12

 

 

$

55

 

 

$

2

 

 

$

 

Cash paid for interest

 

$

585

 

 

$

 

 

$

634

 

 

$

 

Debt discount costs included in accrued expense at period end

 

$

 

 

$

125

 

The accompanying notes are an integral part of these condensed financial statements.

 

 

 


VERRICA PHARMACEUTICALS INC.

Notes to Condensed Financial Statements

(Unaudited)

Note 1—Nature of Business

Verrica Pharmaceuticals Inc. (the “Company”) was formed on July 3, 2013 and is incorporated in the State of Delaware. The Company is a dermatology therapeutics company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases.

 

Liquidity and Capital Resources

In July 2020, the Company received a Complete Response Letter, or CRL from the U.S. Food and Drug Administration, or FDA, for its new drug application, or NDA, for VP-102, the Company’s investigational, proprietary, drug-device combination for the treatment of molluscum contagiosum. The CRL indicated the need for additional information regarding certain aspects of the chemistry, manufacturing and controls, or CMC, process for the drug/device combination as well as human factors validation.

The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. On March 17, 2021, the Company entered into the Torii Agreement (Note 11), pursuant to which the Company received an upfront payment from Torii of $11.5 million in April 2021.On March 25, 2021, the Company closed a follow-on public offering in which it sold 2,033,899 shares of common stock at a public offering price of $14.75 per share, resulting in net proceeds of $28.1 million after deducting underwriting discounts and commissions and offering expenses. As of June 30, 2020,March 31, 2021, the Company had an accumulated deficit of $80.4$104.8 million.  

In March 2020, the Company entered into a Mezzanine Loan Agreement (see Note 7) andpursuant to which the Company borrowed (i) $35.0 million that remains outstanding as of June 30, 2020.  The agreementin March 2020 and (ii) $5.0 million on March 1, 2021.  As discussed in Note 7, the Mezzanine Loan Agreement was amended on October 26, 2020 and now includes a minimum product revenues financial covenant which becomes effective on September 30, 2020, and at any time thereafter, if the balance of the Company’s unrestricted cash, cash equivalents, and marketable securities in accounts maintained at Silicon Valley Bank is less than two times the Company’s aggregate outstanding obligations to the Mezzanine Lenders.liquidity covenant.  If the Company is not in compliance with the minimum product revenues financialliquidity ratio covenant, is effective but not satisfied, the outstanding debt and any related final payment fees, prepayment fees, and accrued interest become due onupon demand.  As a result of the anticipated time to address the CRL, theThe Company believes that, without additional financing, it is probable that it will not be in compliance with the minimum product revenuesliquidity ratio covenant if it becomes effective.  The Company has discussed withat some point in the lenders a potential amendment to the agreement to avoid noncompliance if the minimum product revenues covenant becomes effective and anticipates those discussions will continue during the third quarter of 2020.  There can be no assurance the credit facility will be amended prior to the minimum product revenue covenant becoming effective.next twelve months.  Even if the lenders determined that there was a default underCompany is not in compliance with the agreement,minimum liquidity covenant and the debt becomes due, management believes the Company currently has sufficient funds to meet its operatingoperational requirements for at least the next twelve months from the issuance of these financial statements.

 

Since inception, the Company has financed its operations through sales of convertible preferred stock and the sale of common stock in the Company’s initial public offering, with aggregate gross proceeds of $123.2 million and net proceeds of $114.9 million and the issuance of debt with aggregate gross proceeds of $35.0 million and net proceeds of $34.5 million. As of June 30, 2020, the Company had cash, cash equivalents and marketable securities of $79.6 million.

Note 2—Significant Accounting Policies

Basis of Presentation

The accompanying unaudited interim condensed financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“GAAP”) as determined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) for interim financial information. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, the unaudited interim condensed financial statements reflect all adjustments, which include only normal recurring adjustments necessary for the fair statement of the balances and results for the periods presented. They may not include all of the information and footnotes required by GAAP for complete financial statements. Therefore, these financial statements should be read in conjunction with the Company’s audited financial statements and notes thereto for the year ended December 31, 20192020 filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2020.17, 2021. The results of operations for any interim periods are not necessarily indicative of the results that may be expected for the entire fiscal year or any other interim period.

The Company has been actively monitoring the novel coronavirus (“COVID-19”) situationpandemic and its impact globally. Management believes the financial results for the three and six month periodsyear ended June 30,December 31, 2020 were not significantly impacted by COVID-19. In addition, management believes the remote working arrangements, and travel restrictions and any other regulations imposed by various governmental jurisdictions have had limited impact on the Company’s ability to maintain internal operations during the quarter.year. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. As a direct result of COVID-19, the Company initially decided to delay the initiation of its previously planned Phase 3 clinical trials to evaluate VP-102 in subjects with common warts as well as its previously planned Phase 2 clinical trial to evaluate VP-103 in subjects with plantar warts until conditionswarts.Based on feedback from the FDA regarding a potential Phase 3 trial protocol, we are appropriate. currently evaluating conducting an additional Phase 2 clinical trial of VP-102 for the treatment of common warts.


Use of Estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well asand various other pertinent industry and regulatory authority information, includingfactors believed to be reasonable under the potential future effects of COVID-19,circumstances, the results of which form the


basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Significant Accounting Policies

Revenue

In accordance with FASB’s ASC 606, Revenue from Contracts with Customers (“ASC 606”), the Company recognizes revenue when its customer obtains control of promised goods or 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 the Company determines are within the scope of ASC 606, it 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 applies the five-step model to contracts when it determines that it is probable it 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 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.

License Revenues

The Company’s revenues have been solely generated through licensing arrangements. The terms of the agreement typically include payments to the Company of one or more of the following: nonrefundable, up-front license fees: regulatory and commercial milestone payments; payments for manufacturing supply services; materials shipped to support development; and royalties on net sales of licensed products. 

In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, the Company performs the following steps: 

(i)

identification of the promised goods or services in the contract;

(ii)

determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract;

(iii)

measurement of the transaction price, including the constraint on variable consideration;

(iv)

allocation of the transaction price to the performance obligations; and

(v)

recognition of revenue when (or as) the Company satisfies each performance obligation.

The Company also assesses whether there is an option in a contract to acquire additional goods or services. An option gives rise to a performance obligation only if the option provides a material right to the customer that it would not receive without entering into that contract. Factors that the Company considers in evaluating whether an option represents a material right include, but are not limited to: (i) the overall objective of the arrangement, (ii) the benefit the collaborator might obtain from the arrangement without exercising the option, (iii) the cost to exercise the option (e.g. priced at a significant and incremental discount) and (iv) the likelihood that the option will be exercised. With respect to options determined to be performance obligations, the Company recognizes revenue when those future goods or services are transferred or when the options expire.

The Company’s revenue arrangements may include the following:

Up-front License Fees: If a license is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from nonrefundable, up-front fees allocated to the license when the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring


progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone Payments: At the inception of an agreement that includes regulatory or commercial milestone payments, the Company evaluates whether each milestone is considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. At each reporting period, the Company assesses the probability of achievement of each milestone under its current agreements.

Royalties: If the Company is entitled to receive sales-based royalties from its collaborator, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, provided the reported sales are reliably measurable, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

Manufacturing Supply and Research Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the licensee’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, they are accounted for as separate performance obligations.

The Company receives payments from its licensees based on schedules established in each contract. Upfront payments are recorded as deferred revenue upon receipt, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements. Amounts are recorded as accounts receivable when the Company’s right to consideration is unconditional. The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the licensees and the transfer of the promised goods or services to the licensees will be one year or less.  See Note 11 for a full discussion of the Company’s license revenue.

There have been no material changes in the Company’s other significant accounting policies to those previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019.

Recently Adopted Accounting Pronouncements

In February 2016, the FASB issued Accounting Standard Update (“ASU”) 2016-02, Leases (Topic 842) in order to increase transparency and comparability among organizations by, among other provisions, recognizing lease assets and lease liabilities on the balance sheet for those leases classified as operating leases under previous GAAP. For public companies, ASU 2016-02 is effective for fiscal years beginning after December 15, 2018 (including interim periods within those periods) using a modified retrospective approach and early adoption is permitted. In transition, entities may also elect a package of practical expedients that must be applied in its entirety to all leases commencing before the adoption date, unless the lease is modified, and permits entities to not reassess (a) the existence of a lease, (b) lease classification or (c) determination of initial direct costs, as of the adoption date, which effectively allows entities to carryforward accounting conclusions under previous GAAP. In July 2018, the FASB issued ASU 2018-11, Leases (Topic 842): Targeted Improvements, which provides entities an optional transition method to apply the guidance under Topic 842 as of the adoption date, rather than as of the earliest period presented. The Company adopted Topic 842 on January 1, 2019, using the optional transition method to apply the new guidance as of January 1, 2019, rather than as of the earliest period presented, and elected the package of practical expedients described above. Based on the analysis, on January 1, 2019, the Company recorded an operating lease right-of-use asset of $304,000 and an operating lease liability of $306,000 and eliminated deferred rent of $2,000. See Note 6 for additional information.

In June 2018, the FASB issued ASU No. 2018-07, Compensation-Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year. The Company adopted this ASU as of January 1, 2019 and recorded an adjustment to accumulated deficit and additional paid-in capital of $98,000.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework–Changes to the Disclosure Requirements for Fair Value Measurement, which makes a number of changes meant to add, modify or remove certain disclosure requirements associated with the movement amongst or hierarchy associated with Level 1, Level 2 and Level 3 fair value measurements. This guidance is effective for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. The adoption of this guidance as of January 1, 2020 did not have an impact on the financial statements.

In August 2018, the FASB issued ASU 2018-15, Intangibles–Goodwill and Other–Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement that is a Service Contract, which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The guidance also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The guidance becomes effective for the Company in the year ending December 31, 2020. The adoption of this guidance as of January 1, 2020 did not have an impact on the financial statements.

Net Loss Perper Share

Net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share excludes the potential impact of common stock options and unvested shares of restricted stock because their effect would be anti-dilutive due to the Company’s net loss. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same.


 

The table below provides potential shares outstanding that were not included in the computation of diluted net loss per common share, as the inclusion of these securities would have been anti-dilutive:

 

 

As of June 30,

 

 

As of March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Shares issuable upon exercise of stock options

 

 

2,608,178

 

 

 

1,950,701

 

 

 

3,571,708

 

 

 

2,563,674

 

Non-vested shares under restricted stock grants

 

 

1,148,859

 

 

 

848,859

 

 

 

475,000

 

 

 

1,148,859

 

 

Note 3—Investments in Marketable Securities

 

Investments in marketable securities consisted of the following as of June 30, 2020March 31, 2021 and December 31, 20192020 (in thousands):


 

 

June 30, 2020

 

 

March 31, 2021

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

U.S. Treasury securities

 

$

4,013

 

 

$

18

 

 

$

 

 

$

4,031

 

 

$

9,305

 

 

$

3

 

 

$

 

 

$

9,308

 

Commercial paper

 

 

20,836

 

 

 

9

 

 

 

 

 

 

20,845

 

 

 

34,277

 

 

 

 

 

 

 

 

 

34,277

 

Asset-backed securities

 

 

5,808

 

 

 

6

 

 

 

 

 

 

5,814

 

Total marketable securities

 

$

30,657

 

 

$

33

 

 

$

 

 

$

30,690

 

 

$

43,582

 

 

$

3

 

 

$

 

 

$

43,585

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2019

 

 

December 31, 2020

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

 

Amortized

 

 

Gross Unrealized

 

 

Gross Unrealized

 

 

Fair

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

 

Cost

 

 

Gains

 

 

Losses

 

 

Value

 

U.S. Treasury securities

 

$

7,397

 

 

$

3

 

 

$

 

 

$

7,400

 

 

$

11,607

 

 

$

2

 

 

$

 

 

$

11,609

 

Commercial paper

 

 

31,913

 

 

 

7

 

 

 

(1

)

 

 

31,919

 

 

 

41,674

 

 

 

 

 

 

(1

)

 

 

41,673

 

Asset-backed securities

 

 

13,446

 

 

 

11

 

 

 

 

 

 

13,457

 

 

 

1,502

 

 

 

 

 

 

 

 

 

1,502

 

Total marketable securities

 

$

52,756

 

 

$

21

 

 

$

(1

)

 

$

52,776

 

 

$

54,783

 

 

$

2

 

 

$

(1

)

 

$

54,784

 

 

Unrealized gains and losses on marketable securities are recorded as a separate component of accumulated other comprehensive gain included in stockholders’ equity. Realized gains (losses) are included in interest income (expense) in the statement of operations and comprehensive loss on a specific identification basis. There were no marketable securities with a maturity of greater than one year for either period presented. To date, the Company has not recorded any impairment charges on marketable securities related to other-than-temporary declines in market value.

 

Accretion of bond discount on marketable securities and interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss.

 

Fair value is the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date.  Financial assets and liabilities carried at fair value are classified and disclosed in one of the following three categories:

 

Level 1 — Quoted market prices in active markets for identical assets or liabilities.

 

Level 2 — Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.

 

Level 3 — Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 


The following tables presents fair value of the Company’s marketable securities (in thousands):

 

 

Fair Value Measurement as of June 30, 2020

 

 

Fair Value Measurement as of March 31, 2021

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

4,031

 

 

$

 

 

$

 

 

$

4,031

 

 

$

9,308

 

 

$

 

 

$

 

 

$

9,308

 

Commercial paper

 

 

 

 

 

20,845

 

 

 

 

 

 

20,845

 

 

 

 

 

 

34,277

 

 

 

 

 

 

34,277

 

Asset-backed securities

 

 

 

 

 

5,814

 

 

 

 

 

 

5,814

 

Total assets

 

$

4,031

 

 

$

26,659

 

 

$

 

 

$

30,690

 

 

$

9,308

 

 

$

34,277

 

 

$

 

 

$

43,585

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Fair Value Measurement as of December 31, 2019

 

 

Fair Value Measurement as of December 31, 2020

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

 

Level 1

 

 

Level 2

 

 

Level 3

 

 

Total

 

Assets

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

U.S. treasury securities

 

$

7,400

 

 

$

 

 

$

 

 

$

7,400

 

 

$

11,609

 

 

$

 

 

$

 

 

$

11,609

 

Commercial paper

 

 

 

 

 

31,919

 

 

 

 

 

 

31,919

 

 

 

 

 

 

41,673

 

 

 

 

 

 

41,673

 

Asset-backed securities

 

 

 

 

 

13,457

 

 

 

 

 

 

13,457

 

 

 

 

 

 

1,502

 

 

 

 

 

 

1,502

 

Total assets

 

$

7,400

 

 

$

45,376

 

 

$

 

 

$

52,776

 

 

$

11,609

 

 

$

43,175

 

 

$

 

 

$

54,784

 


 

Note 4—Property and Equipment

Property and equipment, net consisted of (in thousands):

 

 

As of

 

 

As of

 

 

As of

 

 

As of

 

 

June 30,

 

 

December 31,

 

 

March 31,

 

 

December 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Office furniture and fixtures

 

$

299

 

 

$

117

 

Machinery and equipment

 

 

128

 

 

 

102

 

Leasehold improvements

 

$

68

 

 

$

68

 

 

 

101

 

 

 

101

 

Office furniture and fixtures

 

 

48

 

 

 

48

 

Office equipment

 

 

43

 

 

 

31

 

 

 

52

 

 

 

52

 

Construction in process

 

 

2,467

 

 

 

2,027

 

 

 

2,887

 

 

 

2,857

 

 

 

2,626

 

 

 

2,174

 

 

 

3,467

 

 

 

3,229

 

Accumulated depreciation

 

 

(109

)

 

 

(84

)

 

 

(138

)

 

 

(127

)

Total property and equipment, net

 

$

2,517

 

 

$

2,090

 

 

$

3,329

 

 

$

3,102

 

 

The Company has recorded an asset classified as construction in process associated with the construction of a product assembly and packaging line that would be placed into service for commercial manufacturing upon future regulatory product approval.

Note 5—Accrued Expenses and Other Current Liabilities

Accrued expenses and other current liabilities consisted of the following (in thousands):

 

 

As of

June 30,

2020

 

 

As of December 31,

2019

 

 

As of

March 31,

2021

 

 

As of December 31,

2020

 

Compensation and related costs

 

$

883

 

 

$

1,195

 

 

$

893

 

 

$

1,338

 

Clinical trials and drug development

 

 

452

 

 

 

 

 

 

836

 

 

 

611

 

Professional fees

 

 

465

 

 

 

447

 

Construction in process

 

 

429

 

 

 

733

 

 

 

175

 

 

 

277

 

Professional fees

 

 

514

 

 

 

89

 

Interest expense

 

 

211

 

 

 

 

 

 

250

 

 

 

219

 

Other accrued expenses and other current liabilities

 

 

68

 

 

 

19

 

 

 

262

 

 

 

222

 

Total accrued expenses and other current liabilities

 

$

2,557

 

 

$

2,036

 

 

$

2,881

 

 

$

3,114

 

 


Note 6—Leases

Effective January 1, 2019, the Company accounts for its leases under ASC 842, Leases (Topic 842). Under this guidance, arrangements meeting the definition of a lease are classified as operating or financing leases and are recorded on the balance sheet as both a right-of-use asset and lease liability, calculated by discounting fixed lease payments over the lease term at the rate implicit in the lease, if available, otherwise at the Company’s incremental borrowing rate. Lease liabilities are increased by interest and reduced by payments each period, and the right-of-use asset is amortized over the lease term. For operating leases, interest on the lease liability and the amortization of the right-of-use asset result in straight-line rent expense over the lease term. Variable lease expenses, if any, are recorded when incurred.

 

In calculating the right-of-use asset and lease liability, the Company elects to combine lease and non-lease components. The Company excludes short-term leases having initial terms of 12 months or less from the new guidance as an accounting policy election and recognizes rent expense on a straight-line basis over the lease term. The Company does not act as a lessor or have any leases classified as financing leases.

 

The Company leases office space in West Chester, Pennsylvania under an agreement classified as an operating lease that expires in May 2021. The Company does not act as a lessor or have any leases classified as financing leases.On July 1, 2019, the Company entered into a new lease for 5,829 square feet of office space located in West Chester Pennsylvania that is expected to serve as the Company’s new headquarters. Onwhich was further amended on March 12, 2020 the Company entered into an amendment to the lease agreement. The amendment expands the original premises to include 5,372 square feet of additional office space increasing the total rentable premise to 11,201 square feet of space.  For the first six months following the commencement date, the base rent is based on the square footage of the original premises. The Company anticipates the commencement date will occur during the third quarter of 2020, but may be delayed due to the impacts of COVID-19 mandates on office building construction activities. The initial term will expire seven years after the commencement date.on September 1, 2027. Base rent over the initial term is approximately $2.4 million, and the Company is also responsible for its share of the landlord’s operating expense. As a result, amortizationAt the commencement date of the new lease, the Company recorded a right-of-use asset associated with the current property lease is now amortized over the revised remaining useful life. In addition, the useful life of associated leasehold improvements has been accelerated to reflect the expected abandonment of the property, such that they will be fully amortized when the property is vacated.

As of June 30, 2020, the Company had an operating$1.9 million and a lease liability of $0.1$1.9 million which was classified as current.on the condensed balance sheet.

 

The components of lease expense are as follows (in thousands):

 

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

Operating lease:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease costs

 

$

47

 

 

$

47

 

 

$

105

 

 

$

81

 

Short-term lease costs

 

 

7

 

 

 

5

 

 

 

13

 

 

 

10

 

Total rent expense

 

$

54

 

 

$

52

 

 

$

118

 

 

$

91

 


 

 

For the Three Months Ended March 31,

 

 

 

 

2021

 

 

2020

 

 

Operating lease:

 

 

 

 

 

 

 

 

 

Operating lease costs

 

$

89

 

 

$

58

 

 

Short-term lease costs

 

 

5

 

 

 

6

 

 

Total rent expense

 

$

94

 

 

$

64

 

 

                        

Maturities of the Company’s operating lease, excluding short-term leases, as of June 30, 2020March 31, 2021 are as follows (in thousands):

 

Remainder of 2020

 

$

70

 

2021

 

 

58

 

Total lease payments

 

 

128

 

Less imputed interest

 

 

(4

)

Operating lease liability

 

$

124

 

Remainder of 2021

 

$

283

 

2022

 

 

343

 

2023

 

 

349

 

2024

 

 

355

 

2025

 

 

360

 

Thereafter

 

 

613

 

Total undiscounted lease liability

 

 

2,303

 

Less: Imputed interest

 

 

(439

)

Operating lease liability

 

$

1,864

 

The weighted-average remaining term of the Company’s operating lease was 1.06.42 years and the weighted-average discount rate used to measure the present value of the Company’s operating lease liability was 6.75%6.25% as of June 30, 2020.March 31, 2021.

Note 7—Debt

On March 10, 2020 (the “Effective Date”), the Company entered into (i) a mezzanine loan and security agreement (the “Mezzanine Loan Agreement”) with Silicon Valley Bank, as administrative agent and collateral agent (the “Agent”), and Silicon Valley Bank and West River Innovation Lending Fund VIII, L.P., as lenders (the “Mezzanine Lenders”), pursuant to which the Mezzanine Lenders have agreed to lend the Company up to $50.0 million in a series of term loans, and (ii) a loan and security agreement (the “Senior Loan Agreement”, and together with the Mezzanine Loan Agreement, the “Loan Agreements”) with Silicon Valley Bank, as lender (the “Senior Lender”, and together with the Mezzanine Lenders, the “Lenders”), pursuant to which the Senior Lender has agreed to provide the Company with a revolving line of credit of up to $5.0 million. Upon entering into the Loan Agreements, the Company borrowed $35.0 million in term loans from the Mezzanine Lenders (the “Term A Loan”).

 


On October 26, 2020, the Company entered into (i) the first amendment to the Mezzanine Loan Agreement (the “Mezzanine Loan Amendment”) and (ii) the first amendment to the Senior Loan Agreement (the “Senior Loan Amendment” and together with the Mezzanine Loan Amendment the “Loan Agreement Amendments”) with the Lenders, under which the Company borrowed an additional $5.0 million in term loans on March 1, 2021 (the “Term B1 Loan”).

Under the terms of the Mezzanine Loan Agreement, as amended, the Company may, at its sole discretion, borrow from the Mezzanine Lenders up to an additional $15.0$10.0 million in term loans (the “Term BB2 Loan”,).  The Term B1 Loan and Term B2 Loan, together with the Term A Loan, are referred to herein as the “Term Loans”) uponLoans.” The Term B2 Loan will be available for draw if the Company’s achievement of (i) a specified amount in trailing six-month net revenue and (ii) an equity raise of at least $40.0 million (the foregoing clauses (i) and (ii), collectively,Company receives approval from the “Term B Milestone”).  The Company may draw the Term B Loan during the period commencing on the date of the occurrence of the Term B Milestone and ending on the earliest of (i) December 31,FDA for VP-102 prior to September 30, 2021 and (ii)the Company maintains compliance with the minimum liquidity covenant until the earlier of September 30, 2021 or the occurrence of an event of default.

 

Under the terms of the Senior Loan Agreement, as amended, the Company may, at its sole discretion, borrow from the Senior Lender one or more advances on the revolving credit line (the “Revolving Loans”, and together with the Term Loans, the “Loans”) in an aggregate amount not to exceed the lesser of (i) 85% of the aggregate amount then-contained in the Company’s eligible accounts receivable and (ii) $5.0 million. The Senior Loan Agreement provides for the Company to make three anniversary payments of $25,000 each in addition to the $25,000 due upon the Effective Date for an aggregate of $100,000 in total anniversary payments.  In the event the Senior Loan Agreement is terminated prior to maturity, any unpaid portion of the total anniversary payments are due immediately.  The Company recorded the total anniversary fee payment obligation at inception.  As of June 30, 2020, $25,000 and $75,000 of anniversary payments were recorded within other current liabilities and other liabilities, respectively, within the Company’s accompanying balance sheet. 

 

The Company’s obligations under the Senior Loan Agreement and the Mezzanine Loan Agreement, as amended, are secured by, respectively, a first priority perfected security interest and second priority perfected security interest in substantially all of the Company’s current and future assets, other than its intellectual property (except rights to payment from the sale, licensing or disposition of such intellectual property).  The Company has also agreed not to encumber its intellectual property assets, except as permitted by the Loan Agreements.  

 

All of the Loans mature on March 1, 2024 (the “Maturity Date”). The Term Loans will be interest-only through March 31, 2022, followed by 24 equal monthly payments of principal and interest; provided that if the Company draws the Term B Loan, the Term Loans will be interest-only through September 30, 2022, followed by 18 equal monthly payments of principal and interest.


The Term Loans will bear interest at a floating per annum rate equal to the greater of (i) 7.25% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 2.50%. The Revolving Loans will bear interest at a floating per annum rate equal to the greater of (i) 6.00% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 1.25%.

 

TheUnder the terms of the Mezzanine Loan Agreement, as amended, the Company will be required to make a final payment fee of 7.50% of the original principal amount of the Term Loans drawn$3,750,000 payable on the earlier of (i) the Maturity Date, (ii) the acceleration of any Term Loans, or (iii) the prepayment of the Term Loans (the “Final Payment”).  The Company is recording the final payment fee to interest expense using the effective interest rate method over the term of the Term Loan with an increase in long-term debt. The Company may prepay all, or any portion (in increments of at least $1.0 million), of the Term Loans upon 5 business days’ advance written notice to the Agent, provided that the Company will be obligated to pay a prepayment fee equal to (i) 3.00% of the principal amount of the applicable Term Loan $1.5 million if prepaid on or before the first anniversary of the Effective Date,October 26, 2021, (ii) 2.00% of the principal amount of the applicable Term Loan $1.0 million if prepaid between the firstOctober 27, 2021 and second anniversary of the Effective Date,October 26, 2022, and (iii) 1.00% of the principal amount of the applicable Term Loan$0.5 million if prepaid thereafter,between October 27, 2022 and prior to the third anniversary of the Effective DateOctober 26, 2023 and (iv) 0 prepayment fee if prepaid after October 26, 2023 (each, a “Prepayment Fee”).  

 

The Company may terminate the revolving credit line under the Senior Loan Agreement at any time upon 3three business days’ advance written notice to the Senior Lender. If the Company terminates the revolving credit line prior to the Maturity Date, it must pay to the Senior Lender an early termination fee of $50,000 (the “Termination Fee”).

 

TheUnder the Loan Agreements, as amended, the Company is subject to a number of affirmative and restrictive covenants, pursuant to the Loan Agreements, including covenants regarding achievingmaintaining a specified minimum product revenues,liquidity ratio, delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, protection of intellectual property rights, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness or liens, investments and transactions with affiliates, and, beginning as of March 31, 2022, achieving minimum levels of trailing six-month net product revenues, among other customary covenants. As of June 30, 2020March 31, 2021 the Company is in compliance with all covenants.

 

Upon the occurrence of certain events, including but not limited to the Company’s failure to satisfy its payment obligations under the Loan Agreements, the breach of certain of its other covenants under the Loan Agreements, or the occurrence of a material adverse change, cross defaults to other indebtedness or material agreements, judgment defaults and defaults related to failure to maintain governmental approvals failure of which to maintain could result in a material adverse effect, the Agent and the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, to exercise secured party remedies, to receive the Final Payment and Termination Fee and, if the payment of principal and interest is due prior to the Maturity Date, to receive the applicable Prepayment Fee. The Loan Agreements also include subjective acceleration clauses that permit the Lenders to accelerate the maturity date under certain circumstances, including a material adverse change in the Company’s business, operations, or financial condition or a material impairment of the prospect of repayment of the Company’s obligations to the Mezzanine Lenders. Beginning on September 30, 2020 and at any time thereafter, ifPursuant to the Loan Agreement Amendments, the Company is subject to a minimum liquidity covenant defined as the balance of the of the Company’s unrestricted cash, cash equivalents, and marketable securities in accounts maintained at Silicon Valley Bank is lessbeing greater than twoone and one half times the Company’s aggregate outstanding obligations to the Mezzanine Lenders, the covenant regarding achieving minimum product revenues would be effective.Lenders.


 

In July 2020, theThe Company received a Complete Response Letter, or CRL, from the U.S. Food and Drug Administration for its new drug application for VP-102, the Company’s investigational, proprietary, drug-device combination for the treatment of molluscum contagiosum. The CRL indicated the need forbelieves that, without additional information regarding certain aspects of the chemistry, manufacturing and controls, or CMC, process for the drug/device combination as well as human factors validation.  As a result of the anticipated time to address the CRL, the Company believesfinancing, it is probable that it will not be compliancecompliant with its minimum product revenue financialliquidity ratio covenant if it becomes effective, which could occur as early as September 30, 2020.at some point in the next twelve months.  In accordance with FASB ASC 470, since the Mezzanine Loan Agreement contains subjective acceleration clauses and the assessment that it is probable that the minimum product revenueliquidity ratio covenant will not be met, the Company has classified all outstanding principal and final payment fees as a current liability in the accompanying balance sheet as of June 30, 2020.  The Company has discussed with the lenders a potential amendment to the credit facility to avoid noncompliance if the minimum revenue covenant becomes effective and anticipates the discussions will continue during the third quarter of 2020.  No amendment has been finalized as of the date in which these financial statements were made available.March 31, 2021.

 

UponThe Company borrowed $35.0 million upon entering into the Loan Agreement thein March 2020, and an additional $5.0 million on March 1, 2021. The Company received proceeds of $35.0 million in term loans andhas incurred debt discount and issuance costs of $3.3$4.3 million, including the final payment fee of $2.7$3.8 million, that are classified as a contra-liability on the condensed balance sheet.  The Company incurred additional debt issuance costs related to the revolving credit line of $0.1 million, classified as other non-current assets in the condensed balance sheet.  These costs related to the revolving credit line are being amortized to interest expense over the life of the loans using the straight-line method.

 

For the three and six months ended June 30, 2020,March 31, 2021, the Company recognized interest expense of $0.9$1.0 million, and $1.1 million, respectively, of which $0.6 million and $0.8$0.7 million was interest on the term loan and $0.3 million, and $0.3 million, respectively, was non-cash interest expense related to the amortization of deferred debt issuance costs and accrual of the final payment fee.

 

The following table summarizes the composition of debt as reflected on the balance sheet as of June 30, 2020March 31, 2021 (in thousands):

 

Gross proceeds

 

$

35,000

 

 

$

40,000

 

Accrued final payment fee

 

 

2,625

 

 

 

3,750

 

Unamortized debt discount and issuance costs

 

 

(2,905

)

 

 

(3,081

)

Total long-term debt, net

 

$

34,720

 

Total short-term debt, net

 

$

40,669

 


In the event the Company and Lenders amend the credit facility prior to December 31, 2020maintains compliance with its minimum liquidity covenant to avoid an acceleration of payments, without altering the existing repayment schedule by the Company to the lenders, the aggregate maturities of long-term debt as of June 30, 2020March 31, 2021 are as follows (in thousands):

 

Remainder of 2020

 

$

 

2021

 

 

 

Remainder of 2021

 

$

 

2022

 

 

13,125

 

 

 

6,667

 

2023

 

 

17,500

 

 

 

26,667

 

2024 (1)

 

 

4,375

 

 

 

6,666

 

 

$

35,000

 

 

$

40,000

 

(1) Excludes the final payment fee due at time of maturity.

 

 

 

 

 

 

 

 

 

Note 8—Stock-Based Compensation

Stock-based compensation expense, which includes expense for both employees and non-employees, has been reported in the Company’s condensed statements of operations for the three and six months ended June 30,March 31, 2021 and 2020 and 2019 as follows (in thousands):

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

For the Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Research and development

 

$

213

 

 

$

144

 

 

$

390

 

 

$

284

 

 

$

298

 

 

$

177

 

General and administrative

 

 

1,039

 

 

 

702

 

 

 

1,860

 

 

 

1,342

 

 

 

1,105

 

 

 

821

 

Total stock-based compensation

 

$

1,252

 

 

$

846

 

 

$

2,250

 

 

$

1,626

 

 

$

1,403

 

 

$

998

 

Stock Options 

The following table summarizes the Company’s stock option activity for the sixthree months ended June 30, 2020:March 31, 2021:

 

 

 

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

 

 

 

Weighted average

 

 

remaining contractual

 

 

Aggregate intrinsic

 

 

 

 

 

 

Weighted average

 

 

remaining contractual

 

 

Aggregate intrinsic

 

 

Number of shares

 

 

exercise price

 

 

life (in years)

 

 

value

 

 

Number of shares

 

 

exercise price

 

 

life (in years)

 

 

value

 

Outstanding as of December 31, 2019

 

 

1,914,545

 

 

$

9.14

 

 

8.5

 

 

$

12,953,956

 

Outstanding as of December 31, 2020

 

 

2,901,908

 

 

$

9.57

 

 

 

8.0

 

 

$

7,702,295

 

Granted

 

 

705,204

 

 

 

12.70

 

 

 

 

 

 

 

 

 

 

 

736,900

 

 

 

14.50

 

 

 

 

 

 

 

 

 

Exercised

 

 

(7,500

)

 

 

0.90

 

 

 

 

 

 

 

 

 

 

 

(15,708

)

 

 

15.27

 

 

 

 

 

 

 

 

 

Forfeitures

 

 

(4,071

)

 

 

15.13

 

 

 

 

 

 

 

 

 

 

 

(51,392

)

 

 

14.64

 

 

 

 

 

 

 

 

 

Outstanding as of June 30, 2020

 

 

2,608,178

 

 

$

10.12

 

 

 

8.5

 

 

$

5,059,917

 

Options vested and exercisable as of

June 30, 2020

 

 

912,587

 

 

$

7.93

 

 

 

7.7

 

 

$

3,240,963

 

Expired

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Outstanding as of March 31, 2021

 

 

3,571,708

 

 

$

10.49

 

 

 

8.2

 

 

$

16,724,827

 

Options vested and exercisable as of

March 31, 2021

 

 

1,403,303

 

 

$

8.99

 

 

 

6.9

 

 

$

8,684,447

 

 

As of June 30, 2020,March 31, 2021, the total unrecognized compensation related to unvested stock option awards granted was $12.2$16.6 million, which the Company expects to recognize over a weighted-average period of 2.873.2 years.

Restricted Stock

Pursuant to an Amended

In November 2019 and Restated Stock Purchase Agreement (the “Amended and Restated Agreement”) between the Company and its former Chief Scientific Officer (“CSO”), 848,859 shares held by the former CSO are subject to repurchase at $0.0001 per share in the event the CSO ceases to be a consultant. These shares will be released from the repurchase option on the earliest to occur of (i) a change in control, (ii) regulatory approval of the Company’s new drug application for cantharidin, (iii) commercial sale of products and (iv) a covered termination, as defined in the Amended and Restated Agreement.

On November 27, 2019,August 2020, the Company granted 300,000 and 250,000 restricted stock units, respectively to its executive officers.  The restricted stock units vest 50% upon receipt of regulatory approval of the Company’s new drug application for VP-102 for the treatment of molluscum (the “Approval Date”) and 50% shall vest on the one year anniversary of the Approval Date subject to the holders’ continuous service through each applicable date.

The following is a summary of changes in the status of non-vested RSUs:

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

grant date

 

 

 

Number of shares

 

 

fair value

 

Non-vested as of December 31, 2020

 

 

475,000

 

 

$

11.74

 

Granted

 

 

0

 

 

 

 

 

Forfeitures

 

 

0

 

 

 

 

 

Non-vested as of March 31, 2021

 

 

475,000

 

 

$

11.74

 


No compensation expenses have been recognized for these nonvested restricted stock units and the shares subject to the Amended and Restated Agreement as these shares are performance based and the triggering event was not determined to be probable as of June 30, 2020.March 31, 2021.  As of June 30, 2020,March 31, 2021, the total unrecognized compensation expense related to the restricted stock units and shares subject to the Amended and Restated Agreement was $5.0$5.6 million.

Note 9—Related Party Transactions

The

Prior to the completion of the initial public offering (“IPO”) of the Company’s common stock in June 2018, the Company has entered into a services agreementwas controlled by PBM VP Holdings, LLC (“SA”PBM VP Holdings”) withan affiliate of PBM Capital Group, LLC (“PBM”) an affiliate of PBM Capital Investments, LLC, to engage PBM for certain business development, operations, technical, contract, accounting and back office support services.. Paul B. Manning, who is the Chairman and Chief Executive Officer of PBM and the current chairman of the Company’s Board of Directors, and certain entities affiliated with Mr. Manning, continue to be the Company’s largest stockholdershareholder on a collective basis.

On December 2, 2015, the Company entered into a Services Agreement (the “SA”) with PBM. Pursuant to the terms of the SA, which had an initial term of twelve months (and was automatically renewable for successive monthly periods), PBM rendered advisory and consulting services to the Company. Services provided under the SA included certain business development, operations, technical, contract, accounting and back office support services. In consideration for these services, the Company was obligated to pay PBM a monthly management fee. On January 1, 2019, andthe Company amended the SA with PBM, decreasing the monthly fee to $26,333. On October 1, 2019, the SA was amended to reduce the monthly management fee to $26,333 and $5,000 respectively, as a result of a reduction in services provided by PBM.

For the three months ended June 30,March 31, 2021 and 2020, and 2019, the Company incurred expenses under the SA of $15,000 for each period, which were primarily included in general and $79,000, respectively. For the six months ended June 30, 2020 and 2019,administrative expenses.

As of March 31, 2021, the Company incurred expenses under the SA of $30,000had 0 payables due to PBM and $158,000, respectively.its affiliates.

Note 10—Commitments and Contingencies

The Company is involved in ordinary, routine legal proceedings that are not considered by management to be material.  In the opinion of Company counsel and management, the ultimate liabilities resulting from such legal proceedings will not materially affect the financial position of the Company or its results of operations or cash flows.

Note 11—Subsequent EventLicense and Collaboration Agreements

OnIn August 4, 2020, the Company entered into an Option Agreementoption agreement with Torii Pharmaceutical Co., Ltd. (“Torii”) for the development and commercialization of the Company’s product candidates for the treatment of molluscum contagiosum and common


warts in Japan, including VP-102.VP-102 (the “Option Agreement”).  Torii has agreed to paypaid the Company $0.5 million to secure the exclusive option.  The $0.5 million is included in deferred revenue as of December 31, 2020 in the balance sheet.

On March 2, 2021, Torii may exerciseexercised the exclusive option in the Option Agreement.  On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to obtainwhich the Company granted Torii an exclusive license rights untilto develop and commercialize the Company’s product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan, including VP-102.  Additionally, the Company granted Torii a right of first negotiation with respect to additional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan.

Pursuant to the Torii Agreement, the Company received an up-front payment from Torii of $11.5 million in April 2021. Additionally, the Company is entitled to receive from Torii an additional $58 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid-30’s to the mid-40’s of net sales.  The transfer payments shall be payable, on a product-by-product basis, beginning on the first commercial sale of such product and ending on the latest of (a) expiration of the last-to-expire valid claim contained in certain licensed patents in Japan that cover such product, (b) expiration of regulatory exclusivity for the first indication for such product in Japan, and, (c) (i) with respect to the first product, ten years after first commercial sale of such product, and, (ii) with respect to any other product, the later of six months(x) ten years after the effective datefirst commercial sale of the Optionfirst product and (y) five years after first commercial sale of such product.

The Torii Agreement expires on a product-by-product basis upon expiration of Torii’s obligation under the agreement to make transfer price payments for such product.  Torii has the right to terminate the agreement upon specified prior written notice to us.  Additionally, either party may terminate the agreement in the event of an uncured material breach of the agreement by, or ten businesss days afterinsolvency of, the other party.  The Company providesmay terminate the agreement in the event that Torii with minutescommences a legal action challenging the validity, enforceability or scope of any Type A meeting with the FDA regarding VP-102.licensed patents.

 


In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology to research, develop, manufacture, have manufactured, use, sell, have sold, offer for sale, import, and otherwise commercialize products for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma (the” Lytix Agreement”).  As part of the Lytix Agreement, the Company paid Lytix a one-time up-front fee of $0.3 million in 2020.  In addition, in February 2021, the Company paid Lytix a one-time $2.3 million payment upon the achievement by Lytix of a regulatory milestone. The $0.3 million was recognized in research and development expense in the statement of operations for the year ended December 31, 2020.  The Company is also obligated to pay up to $111.0 million contingent on achievement of specified development, regulatory, and sales milestones, as well as tiered royalties based on worldwide annual net sales ranging in the low double digits to the mid-teens, subject to certain customary reductions. The Company’s obligation to pay royalties expires on a country-by-country and product-by-product basis on the later of the expiration or abandonment of the last to expire licensed patent covering LTX-315 anywhere in the world and expiration of regulatory exclusivity for LTX-315 in such country. Additionally, all upfront fees and milestone based payments received by the Company from a sublicensee will be treated as net sales and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50% but decreases based on the stage of development of LTX-315 at the time such sublicense is granted.

Note 12—Subsequent Event

None.


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 in conjunction with (i) our unaudited interim condensed financial statements and the related notes thereto included elsewhere in this Quarterly Report on Form 10-Q and (ii) our audited condensed financial statements and notes thereto and management’s discussion and analysis of financial condition and results of operations for the years ended December 31, 20182019 and 20192020 included in our Annual Report on Form 10-K for the year ended December 31, 2019,2020, filed with the Securities and Exchange Commission (the “SEC”) on March 13, 2020.17, 2021. Our financial statements have been prepared in accordance with U.S. GAAP.

We own various U.S. federal trademark applications and unregistered trademarks, including our company name.  All other trademarks or trade names referred to in this Quarterly Report on Form 10-Q are the property of their respective owners.  Solely for convenience, the trademarks and trade names in this report are referred to without the symbols ® and , but such references should not be construed as an indication that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”), including, without limitation, statements regarding our expectations, beliefs, intentions or future strategies that are signified by the words “expect,” “anticipate,” “intend,” “believe,” “may,” “plan,” “seek” or similar language. All forward-looking statements included in this document are based on information available to us on the date hereof, and we assume no obligation to update any such forward-looking statements. Our business and financial performance are subject to substantial risks and uncertainties. Our actual results could differ materially from those discussed in these forward-looking statements. In evaluating our business, you should carefully consider the information set forth in this Quarterly Report under Part II - Item 1A “Risk Factors,” and in our other filings with the SEC.

Overview

We are a dermatology therapeutics company committed to the development and commercialization of novel treatments that provide meaningful benefit for people living with skin diseases. Our lead product candidate, VP-102, is a proprietary drug-device combination of our topical solution of cantharidin, a widely recognized, naturally sourced agent to treat topical dermatological conditions, administered through our single-use precision applicator. We are initially developing VP-102 for the treatment of molluscum contagiosum, or molluscum, a highly contagious and primarily pediatric viral skin disease, and common warts. There are currently no products approved by the U.S. Food and Drug Administration, or FDA, nor is there an established standard of care for either of these diseases, resulting in significant undertreated populations in two of the largest unmet needs in dermatology. In addition to patent protection we are seeking, VP-102 has the potential to be the first FDA-approved product for molluscum and for its active pharmaceutical ingredient, or API, to be characterized as a new chemical entity, or NCE, with the five years of non-patent regulatory exclusivity associated with that designation.WebelieveVP-102 has thepotentialto qualifyfor pediatricexclusivity, in common warts, which would provideforan additionalsixmonthsof non-patentexclusivity.

In January 2019, we reported positive top-line results from our Phase 3 CAMP-1 and CAMP-2 pivotal trials with VP-102 for the treatment of molluscum. Both clinical trials evaluated the safety and efficacy of VP-102 compared to placebo. In each trial, we observed that a clinically and statistically significant proportion of subjects treated with VP-102 achieved complete clearance of all treatable molluscum lesions compared to subjects treated with placebo. VP-102 was well-tolerated in both trials, with no serious adverse events reported in VP-102 treated subjects. CAMP-1 was conducted under a special protocol assessment, or SPA, agreement with the FDA. Based on the results from these trials, we submitted a new drug application, or NDA, to the FDA for VP-102 for the treatment of molluscum in September 2019.  In November 2019, we received notice that the FDA accepted the NDA for filing, with a Prescription Drug User Fee Act, or PDUFA, goal date of July 13, 2020. In July 2020, we received a Complete Response Letter, or CRL, from the FDA for our NDA. The CRL indicated the need for additional information regarding certain aspects of the chemistry, manufacturing and controls, or CMC, processprocesses for the drug/device combination as well as human factors validation.  The FDA did not identify any clinical deficiencies.  We plan to request aA Type A meeting was held with the FDA in October 2020 to discuss the issues that were identified in the CRL and the resubmission of the NDA for VP-102.  We resubmitted our NDA for VP-102 for the treatment of molluscum in December 2020.  In February 2021, we received notice that the FDA accepted the resubmitted NDA for filing, with a PDUFA goal date of June 23, 2021.

In June 2019, we announced positive topline results from our COVE-1 Phase 2 open label clinical trial of VP-102 for the treatment of verruca vulgaris, or common warts. Based on the results of the COVE-1 trial, and following an End-of-Phase 2 meeting withfeedback from the FDA we planned to initiate tworegarding a potential Phase 3 trial protocol, we are currently evaluating conducting an additional Phase 2 clinical trials intrial of VP-102 for the first halftreatment of 2020. However, as previously disclosed, we have decided to defer initiation of those clinical trials.common warts.  


In addition, we are also developing VP-102 for the treatment of external genital warts. We initiated a Phase 2 clinical trial evaluating the optimal dose regimen, efficacy, safety and tolerability of VP-102 in patients with external genital warts in June 2019.  We expect to reportIn November 2020, we announced positive topline data results from thisour Phase 2 clinical trial of VP-102 for the treatment of external genital warts.  Based on the results of the Phase 2 trial, we requested an end of Phase 2 meeting with the FDA in the second halffirst quarter of 2020.2021. In addition, we are conducting necessary drug development activities for VP-103, our second cantharidin-based product candidate, and had plannedare evaluating when to initiate a Phase 2 clinical trial in subjectsfor the treatment of plantar warts. We also intend to develop our third product candidate, LTX-315, for the treatment of dermatological oncology indications.

On March 17, 2021, we entered into a collaboration and license agreement, or the Torii Agreement, with plantarTorii Pharmaceutical Co., Ltd., or Torii, pursuant to which we granted Torii an exclusive license to develop and commercialize our product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in mid-2020. However, as previously disclosed,Japan, including VP-102.  Additionally, we have decidedgranted Torii a right of first negotiation with respect to defer initiationadditional indications for the licensed products and certain additional products for use in the licensed field, in each case in Japan. Pursuant to the Torii Agreement, we received an up-front payment from Torii of those clinical trials.$11.5 million in April 2021.  Additionally, we are entitled to receive from Torii an additional $58.0 million in aggregate payments contingent on achievement of specified development, regulatory, and sales milestones, in addition to tiered transfer price payments for supply of product in the percentage range of the mid-30s to the mid-40s of net sales

In August 2020, we entered into an exclusive license agreement with Lytix Biopharma AS, or Lytix, pursuant to which we obtained a worldwide, license for certain technology of Lytix to develop LTX-315 for use in all malignant and pre-malignant dermatological indications, other than metastatic melanoma and metastatic merkel cell carcinoma.  We retainintend to submit an Investigational New Drug Application, or IND, for LTX-315 in the second half of 2021.    exclusive,royalty-freerightsto our productcandidatesacrossall indications.

Our strategy is to advance VP-102 through regulatory approval and self-commercialize in the United States for the treatment of several skin diseases. We intend to build a specialized sales organization in the United States focused on pediatric dermatologists, dermatologists, and select pediatricians. In the future, we also intend to develop VP-102 for commercialization in additional geographic regions, either alone or together with a strategic partner.

We have been actively monitoring the novel coronavirus, or COVID-19, pandemic and its impact globally. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, including as a result of new information that may emerge concerning COVID-19 and the actions taken to contain it or treat COVID-19. As a direct result of COVID-19, we decided to delay the initiation of our previously planned Phase 3 clinical trials to evaluate VP-102 in subjects with common warts as well as our previously planned Phase 2 clinical trial to evaluate VP-103 in subjects with plantar warts. 

Since our inception in 2013, our operations have focused on developing VP-102, organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and conducting clinical trials. We do not have any product candidates approved for sale and have not generated any revenue from product sales. We have funded our operations primarily through the sale of equity and equity-linked securities and through borrowing under our loan agreement with Silicon Valley Bank.

On June 19, 2018,March 25, 2021, we completed an IPO of common stock,closed a follow-on public offering in which resulted in the issuance and sale of 5,750,000we sold 2,033,899 shares of common stock at a public offering price of $15.00$14.75 per share, generatingresulting in net proceeds of $78.4$28.1 million after deducting underwriting discounts and othercommissions and offering costs. On March 10, 2020, we entered into (i) a mezzanine loan and security agreement, or the Mezzanine Loan Agreement, with Silicon Valley Bank, as administrative agent and collateral agent, or the Agent, and Silicon Valley Bank and West River Innovation Lending Fund VIII, L.P., as lenders, or the Mezzanine Lenders, pursuant to which the Mezzanine Lenders have agreed to lend us up to $50.0 million in a series of term loans, and (ii) a loan and security agreement, or the Senior Loan Agreement, and together with the Mezzanine Loan Agreement, the Loan Agreements, with Silicon Valley Bank, as lender, or the Senior Lender, and together with the Mezzanine Lenders, the Lenders, pursuant to which the Senior Lender has agreed to provide us a revolving line of credit of up to $5.0 million. Upon entering into the Loan Agreements, we borrowed $35.0 million in term loans from the Mezzanine Lenders. The availability for the remaining $15.0 million in term loans is subject to our achievement of (i) a specified amount in trailing six-month net revenue and (ii) a specified amount raised in equity.

expenses. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 2020March 31, 2021, combined with the $11.5 million up-front payment we received pursuant to the Torii Agreement in April 2021, will be sufficient to support our planned operations at least through the fourthsecond quarter of 2021.2023.

Since inception, we have incurred significant operating losses. For the sixthree months ended June 30,March 31, 2021 and the year ended December 31, 2020, and 2019, our net loss was $19.2$0.9 million and $14.5$42.7 million, respectively. As of June 30, 2020,March 31, 2021, we had an accumulated deficit of $80.4$104.8 million. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We anticipate that our expenses will increase significantly in connection with our ongoing activities, as we:

 

continue our ongoing clinical programs evaluating VP-102 for the treatment of common warts as well as initiate and complete additional clinical trials, as needed;

initiate clinical trials evaluating VP-102 for the treatment of external genital warts;

initiate clinical trials evaluating VP-103 for the treatment of plantar warts, and LTX-315 for the treatment of dermatological oncology indications;

pursue regulatory approvals for VP-102 for the treatment of molluscum, and eventually for the treatment of common warts, external genital warts or any other indications we may pursue for VP-102, as well as for VP-103;VP-103 or LTX-315;


 

seek to discover and develop additional product candidates;

ultimately establish a commercialization infrastructure and scale up external manufacturing and distribution capabilities to commercialize any product candidates for which we may obtain regulatory approval, including VP-102, VP-103 and VP-103;LTX-315;

 

continue our ongoing clinical programs evaluating VP-102 for the treatment of common warts and external genital warts as well as initiate and complete additional clinical trials, as needed;

initiate clinical trials evaluating VP-103 for the treatment of plantar warts;

seek to discover and develop additional product candidates;

seek to in-license or acquire additional product candidates for other dermatological conditions;

 

adapt our regulatory compliance efforts to incorporate requirements applicable to marketed products;

 

maintain, expand and protect our intellectual property portfolio;

 

hire additional clinical, manufacturing and scientific personnel;

 

add operational, financial and management information systems and personnel, including personnel to support our product development and planned future commercialization efforts; and

 

incur additional legal, accounting and other expenses in operating as a public company.company


Services Agreement with PBM Capital Group, LLC

We have entered into a services agreement (“SA”) with PBM Capital Group, LLC (“PBM”) an affiliate of PBM Capital Investments, LLC, to engage PBM for certain business development, operations, technical, contract, accounting and back office support services. Paul B. Manning, who is the Chairman and Chief Executive Officer of PBM and the current chairman of our Board of Directors, and certain entities affiliated with Mr. Manning, continue to be our largest stockholder on a collective basis.

On January 1, 2019 and October 1, 2019, the SA was amended to reduce the monthly management fee to $26,333 and $5,000, respectively, as a result of a reduction in services provided by PBM.

For the three months ended June 30, 2020 and 2019, we incurred expenses under the SA of $15,000 and $79,000, respectively. For the three months ended June 30, 2020 and 2019, we incurred expenses under the SA of $30,000 and $158,000, respectively.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which have been prepared in accordance with U.S. GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with GAAP, we evaluate our estimates and judgments on an ongoing basis.

 

There have been no material changes inA summary of our significant accounting policies to those previouslyare disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 other than2020. However, we believe that the adoption of two FASB Accounting Standards Updates. Seeadditional accounting policies disclosed in Note 2 to our condensed financial statements for a description of recent accounting pronouncements applicablestatement are important to understanding and evaluating our condensedreported financial statements.results.

Components of Results of Operations

License Revenue

We have not generatedreceived any revenue from product sales since our inception. License revenue represents revenue from the Torii Agreement pursuant to which the Company granted Torii an exclusive license to develop and commercialize our product candidates that contain a topical formulation of cantharidin for the treatment of molluscum contagiosum and common warts in Japan including VP-102.

Operating Expenses

Research and Development Expenses

Research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. We expense research and development costs as incurred. These expenses include:

 

expenses incurred under agreements with contract research organizations, or CROs, as well as investigative sites and consultants that conduct our clinical trials and preclinical studies;

 

manufacturing and supply scale-up expenses and the cost of acquiring and manufacturing preclinical and clinical trial supply and commercial supply, including manufacturing validation batches;

 

outsourced professional scientific development services;

 

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

 

expenses relating to regulatory activities; and

 

laboratory materials and supplies used to support our research activities.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect our research and development expenses to increase over the next several years as we increase personnel costs, including stock-based compensation, initiate and conduct Phase 3 clinical trials of VP-102 in patients with common warts, conduct our ongoing Phase 2 trial with VP-102 in patients with external genital warts, initiate a Phase 2 trial with VP-103 in patients with plantar warts, LTX-315 for dermatological oncology indications, and conduct other clinical trials and prepare regulatory filings for our product candidates.candidates.


The successful development of our product candidates is highly uncertain. At this time, we cannot reasonably estimate or know the nature, timing and costs of the efforts that will be necessary to complete the remainder of the development of, or when, if ever, material net cash inflows may commence from our product candidates. This uncertainty is due to the numerous risks and uncertainties associated with the duration and cost of clinical trials, which vary significantly over the life of a project as a result of many factors, including:

 

the impact onnumber of clinical sites included in the timing of our clinical trials due to the COVID-19 pandemic;trials;

 

the number of clinical sites included in the trials;


the length of time required to enroll suitable patients;

 

the number of patients that ultimately participate in the trials;

 

the number of doses patients receive;

 

the duration of patient follow-up; and

 

the results of our clinical trials.

Our expenditures are subject to additional uncertainties, including the manufacturing process for our product candidates, the terms and timing of regulatory approvals, and the expense of filing, prosecuting, defending and enforcing any patent claims or other intellectual property rights. We may never succeed in achieving regulatory approval for our product candidates. We may obtain unexpected results from our clinical trials. We may elect to discontinue, delay or modify clinical trials of our product candidates. A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or other regulatory authorities were to require us to conduct clinical trials beyond those that we currently anticipate, or if we experience significant delays in enrollment in any of our clinical trials, or to make any necessary modifications to the VP-102 single-use applicator, we could be required to expend significant additional financial resources and time on the completion of clinical and/or pharmaceutical quality/CMC development.development.

General and Administrative Expenses

General and administrative expenses consist principally of salaries and related costs for personnel in executive and administrative functions, including stock-based compensation, travel expenses and recruiting expenses. Other general and administrative expenses include market research costs, insurance costs, and professional fees for audit, tax and legal services.

We anticipate that our general and administrative expenses, including payroll and related expenses, will increase in the future as we continue to increase our headcount to support the expected growth in our business, expand our operations and organizational capabilities, and prepare for potential commercialization of VP-102 for the treatment of molluscum, if successfully developed and approved. We also anticipate increased expenses associated with general operations, including costs related to audit, tax and legal services, director and officer insurance premiums, and investor relations costs.

Results of Operations for the three months ended June 30,March 31, 2021 and 2020 and 2019

The following table summarizes our results of operations for the three months ended June 30,March 31, 2021 and 2020 and 2019 (in thousands):

 

 

For the Three Months Ended June 30,

 

 

 

 

 

 

For the Three Months Ended March 31,

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

 

 

2021

 

 

2020

 

 

Change

 

 

 

 

 

 

 

 

 

 

 

 

 

License revenue

 

$

12,000

 

 

$

 

 

$

12,000

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

3,521

 

 

$

3,928

 

 

$

(407

)

 

 

5,362

 

 

 

4,892

 

 

 

470

 

General and administrative

 

 

5,110

 

 

 

3,593

 

 

 

1,517

 

 

 

6,578

 

 

 

4,988

 

 

 

1,590

 

Total operating expenses

 

 

8,631

 

 

 

7,521

 

 

 

1,110

 

 

 

11,940

 

 

 

9,880

 

 

 

2,060

 

Loss from operations

 

 

(8,631

)

 

 

(7,521

)

 

 

(1,110

)

Income (loss) from operations

 

 

60

 

 

 

(9,880

)

 

 

9,940

 

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

126

 

 

 

523

 

 

 

(397

)

 

 

32

 

 

 

278

 

 

 

(246

)

Interest expense

 

 

(904

)

 

 

(3

)

 

 

(901

)

 

 

(1,028

)

 

 

(220

)

 

 

(808

)

Total other (expense) income

 

 

(778

)

 

 

520

 

 

 

(1,298

)

 

 

(996

)

 

 

58

 

 

 

(1,054

)

Net loss

 

$

(9,409

)

 

$

(7,001

)

 

$

(2,408

)

 

$

(936

)

 

$

(9,822

)

 

$

8,886

 


 

License Revenue

License revenue was $12.0 million for the three months ended March 31, 2021 compared to no license revenue for the three months ended March 31, 2020.  Pursuant to the exercise of the license option on March 17, 2021 per the Torii Agreement, the Company recognized revenue of $12.0 million comprised of (i) $0.5 received in December 2020, reflected as deferred revenue on the balance sheet ended December 31, 2020 and (ii) the $11.5 million up-front payment paid in April 2021, reflected as a receivable on the balance sheet as of March 31, 2021.

Research and Development Expenses

Research and development expenses were $3.5$5.4 million for the three months ended June 30, 2020,March 31, 2021, compared to $3.9$4.9 million for the three months ended June 30, 2019.March 31, 2020. The decreaseincrease of $0.4$0.5 million was primarily attributable to a one-time $2.3 million milestone payment made to Lytix upon the achievement of a regulatory milestone for LTX-315, partially offset by decreased CMC and clinical costs related to our development of VP-102 for molluscum, partially offset by increased compensation costs.external genital warts, and common warts.

General and Administrative Expenses

General and administrative expenses were $5.1$6.6 million for the three months ended June 30, 2020,March 31, 2021, compared to $3.6$5.0 million for the three months ended June 30, 2019.March 31, 2020. The increase of $1.5 million was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.


Interest Income

Interest income for the periods presented consisted primarily of interest earned on our cash, cash equivalents and marketable securities.  The decrease of $0.4 million was primarily a result of lower interest income due to lower interest rates.  

Interest Expense

Interest expense for the three months ended June 30, 2020 consisted of interest expense on the Mezzanine Loan Agreement as noted in Note 7 to our condensed financial statements.

Results of Operations for the Six Months Ended June 30, 2020 and 2019

The following table summarizes our results of operations for the six months ended June 30, 2020 and 2019 (in thousands):

 

 

For the Six Months Ended June 30,

 

 

 

 

 

 

 

2020

 

 

2019

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

8,413

 

 

$

8,415

 

 

$

(2

)

General and administrative

 

 

10,098

 

 

 

7,132

 

 

 

2,966

 

Total operating expenses

 

 

18,511

 

 

 

15,547

 

 

 

2,964

 

Loss from operations

 

 

(18,511

)

 

 

(15,547

)

 

 

(2,964

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

404

 

 

 

1,070

 

 

 

(666

)

Interest expense

 

 

(1,124

)

 

 

(3

)

 

 

(1,121

)

Total other (expense) income

 

 

(720

)

 

 

1,067

 

 

 

(1,787

)

Net loss

 

$

(19,231

)

 

$

(14,480

)

 

$

(4,751

)

Research and Development Expenses

Research and development expenses were $8.4 million for the six months ended June 30, 2020, compared to $8.4 million for the six months ended June 30, 2019. The decrease was primarily attributable to decreased costs related to our development of VP-102 for molluscum, partially offset by increased compensation costs and increased clinical costs related to our development of VP-102 for external genital warts and common warts.  

General and Administrative Expenses

General and administrative expenses were $10.1 million for the six months ended June 30, 2020, compared to $7.1 million for the six months ended June 30, 2019. The increase of $3.0$1.6 million was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.

Interest Income

Interest income for the periods presented consisted primarily of interest earned on our cash, cash equivalents and marketable securities.  The decrease of $0.7$0.2 million was primarily a result of lower interest income due to lower interest rates.  

Interest Expense

Interest expense for the sixthree months ended June 30, 2020March 31, 2021 consisted of interest expense on the Mezzanine Loan Agreement as noted in Note 7 to our condensed financial statements.

Liquidity and Capital Resources

Since our inception, we have not generated any revenue from product sales and have incurred net losses and negative cash flows from our operations. We have financed our operations since inception through sales of our convertible preferred stock and the sale of our common stock in our IPO, as well as in a subsequent offering of our common stock noted below, receiving aggregate gross proceeds of $123.2 million and net proceeds of $114.9 million and most recently, $35.0from our IPO, $40.0 million of gross proceeds from the Mezzanine Loan Agreement noted below.below and $28.1 million of net proceeds from our public offering of common stock in March 2021.


As of June 30, 2020,March 31, 2021, we had cash, cash equivalents and marketable securities of $79.6$87.7 million. Cash in excess of immediate requirements is invested in accordance with our investment policy, primarily with a view to liquidity and capital preservation.

On March 25, 2021, we closed a follow-on public offering in which we sold 2,033,899 shares of common stock at a public offering price of $14.75 per share, resulting in net proceeds of $28.1 million after deducting underwriting discounts and commissions and offering expenses.

On March 10, 2020, or the Effective Date, we entered into (i) the Mezzanine Loan Agreement with the Agent, and the Mezzanine Lenders, pursuant to which the Mezzanine Lenders have agreed to lend us up to $50.0 million in a series of term loans, and (ii) the Senior Loan Agreement with the Senior Lender, pursuant to which the Senior Lender has agreed to provide us with a revolving line of credit of up to $5.0 million. Upon entering into the Loan Agreements, we borrowed $35.0 million in term loans from the Mezzanine Lenders. The availability forLenders, or the remaining $15.0Term A Loan.

On October 26, 2020, we entered into (i) the first amendment to the Mezzanine Loan Agreement, or the Mezzanine Loan Amendment and (ii) the first amendment to the Senior Loan Agreement, or the Senior Loan Amendment with the Lenders, under which we borrowed an additional $5.0 million in term loans is subjecton March 1, 2021.

Under the terms of the Mezzanine Loan Agreement, as amended, we may, at our sole discretion, borrow from the Mezzanine Lenders up to an additional $10.0 million in term loans, or the Term B2 Loan.  The Term B2 Loan will be available for draw if we receive approval from the FDA for VP-102 prior to September 30, 2021 and maintain compliance with the minimum liquidity covenant until the earlier of September 30, 2021 or the occurrence of an event of default. 

Under the terms of the Senior Loan Agreement, as amended, we may, at our achievementsole discretion, borrow from the Senior Lender one or more advances on the revolving credit line, or the Revolving Loans, and together with the Term Loans, the Loans) in an aggregate amount not to exceed the lesser of (i) a specified85% of the aggregate amount then-contained in trailing six-month net revenueour eligible accounts receivable and (ii) $5.0 million.  


Our obligations under the Senior Loan Agreement and the Mezzanine Loan Agreement, as amended, are secured by, respectively, a specified amount raisedfirst priority perfected security interest and second priority perfected security interest in equity. See Note 7substantially all of our current and future assets, other than our intellectual property (except rights to payment from the sale, licensing or disposition of such intellectual property).  We have also agreed not to encumber our condensed financial statements for additional information.intellectual property assets, except as permitted by the Loan Agreements.  

All of the Loans mature on March 1, 2024, or the Maturity Date. The Term Loans will be interest-only through March 31, 2022, followed by 24 equal monthly payments of principal and interest; provided that if we draw the Term B Loan, the Term Loans will be interest-only through September 30, 2022, followed by 18 equal monthly payments of principal and interest. The Term Loans will bear interest at a floating per annum rate equal to the greater of (i) 7.25% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 2.50%. The Revolving Loans will bear interest at a floating per annum rate equal to the greater of (i) 6.00% and (ii) the sum of (a) the prime rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, plus (b) 1.25%.

Under the terms of the Mezzanine Loan Agreement, as amended, we will be required to make a final payment fee of $3,750,000 payable on the earlier of (i) the Maturity Date, (ii) the acceleration of any Term Loans, or (iii) the prepayment of the Term Loans, or the Final Payment.  We are recording the final payment fee using the effective interest rate method over the term of the Term Loan with an increase in debt. We may prepay all, or any portion of the Term Loans upon 5 business days advance written notice to the Agent, provided that we will be obligated to pay a prepayment fee equal to (i) $1.5 million if  prepaid on or before October 26, 2021, (ii) $1.0 million if  prepaid between October 27, 2021 and October 26, 2022, and (iii) $0.5 million if prepaid between October 27, 2022 and October 26, 2023 and (iv) no prepayment fee if prepaid after October 26, 2023, each, a Prepayment Fee.

 

We may terminate the revolving credit line under the Senior Loan Agreement at any time upon three business days advance written notice to the Senior Lender. If we terminate the revolving credit line prior to the Maturity Date, we must pay to the Senior Lender an early termination fee of $50,000, or the Termination Fee.

Under the Loan Agreements, as amended, we are subject to a number of affirmative and restrictive covenants, pursuant to the Loan Agreements, including covenants regarding achievingmaintaining a specified minimum product revenues,liquidity ratio, delivery of financial statements, maintenance of inventory, payment of taxes, maintenance of insurance, protection of intellectual property rights, dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness or liens, investments and transactions with affiliates, and, beginning as of March 31, 2022, achieving minimum levels of trailing six-month net product revenues, among other customary covenants. As of June 30, 2020,March 31, 2021, we arewere in compliance with all covenants.

Upon the occurrence of certain events, including but not limited to our failure to satisfy our payment obligations under the Loan Agreements, the breach of certain of our other covenants under the Loan Agreements, or the occurrence of a material adverse change, cross defaults to other indebtedness or material agreements, judgment defaults and defaults related to failure to maintain governmental approvals failure of which to maintain could result in a material adverse effect, the Agent and the Lenders will have the right, among other remedies, to declare all principal and interest immediately due and payable, to exercise secured party remedies, to receive the Final Payment and Termination Fee and, if the payment of principal and interest is due prior to the Maturity Date, to receive the applicable Prepayment Fee.

As a result of the anticipated time to address the CRL received from the FDA in July 2020, weWe believe that without additional financing, it is probable that we will not be in compliance with the minimum product revenuesliquidity ratio covenant if it becomes effective, which could occur at some point in the next twelve monthsas early as September 30, 2020..  In accordance with FASB ASC 470, since the Mezzanine Loan Agreement contains subjective acceleration clauses and assessment that it is probable that the minimum product revenueliquidity ratio covenant will not be met, we have classified all outstanding principal and final payment fees as a current liability in the accompanying balance sheet as of June 30, 2020.  We have discussedMarch 31, 2021.  Even if we are not in compliance with the lenders a potential amendment tominimum liquidity covenant and the credit facility to avoid noncompliance if the minimum revenue covenantdebt becomes effective and anticipate those discussions will continue during the third quarter of 2020.No amendment has been finalized as of the date in which these financial statements were made available.There can be no assurance the credit facility will be amended prior to the minimum product revenue covenant becoming effective. Even if the lenders determined that there was a default under the agreement,due, we believe that we currently have sufficient funds to meet our operating requirements for at least the next twelve months from the issuance of these financial statements.

Cash Flows

The following table summarizes our cash flows for the sixthree months ended June 30,March 31, 2021 and 2020 and 2019 (in thousands):


 

 

For the Six Months Ended June 30,

 

 

For the Three Months Ended March 31,

 

 

2020

 

 

2019

 

 

2021

 

 

2020

 

Net cash used in operating activities

 

$

(16,500

)

 

$

(11,967

)

 

$

(10,785

)

 

$

(7,906

)

Net cash provided by investing activities

 

 

21,404

 

 

 

21,333

 

 

 

10,835

 

 

 

18,274

 

Net cash provided by financing activities

 

 

34,787

 

 

 

215

 

 

 

33,365

 

 

 

34,877

 

Net increase in cash and cash equivalents

 

$

39,691

 

 

$

9,581

 

 

$

33,415

 

 

$

45,245

 

Operating Activities

During the sixthree months ended June 30,March 31, 2021, operating activities used $10.8 million of cash, primarily resulting from a change in operating assets and liabilities of $11.7 million due to an increase in license receivables of $11.5 million related to the Torii Agreement (See Note 11 – License and Collaboration Agreements) and a net loss of $0.9 million, offset by non-cash stock-based compensation of $1.4 million and non-cash interest of $0.4 million. Revenue of $12.0 million related to the Torii Agreement was reflected in the net loss for the three months ended March 31, 2021.  

During the three months ended March 31, 2020, operating activities used $16.5$7.9 million of cash, primarily resulting from a net loss of $19.2$9.8 million partially offset by non-cash stock-based compensation of $2.3$1.0 million. Net cash provided by changes in operating assets and liabilities consisted primarily of an increasea decrease in prepaid expenses of $0.6 million as a result of up-front payments made in 2019 for research and other assetsdevelopment activities.

Investing Activities

During the three months ended March 31, 2021, net cash provided by investing activities of $0.7$10.8 million was due to sales and maturities of marketable securities of $20.5 million, partially offset by an increase in accrued expensespurchases of marketable securities of $9.3 million and other current liabilitiespurchase of $0.8property and equipment of $0.3 million.

During the sixthree months ended June 30, 2019, operating activities used $12.0 million of cash, primarily resulting from a net loss of $14.5 million partially offset by non-cash stock-based compensation of $1.6 million, and cash provided by changes in operating assets and liabilities of $1.4 million.  Net cash provided by changes in operating assets and liabilities consisted primarily of an increase in accrued expenses and other current liabilities of $1.1 million and a decrease in prepaid expense and other assets of $0.4 million.


Investing Activities

During the six months ended June 30,March 31, 2020, net cash provided by investing activities of $21.4$18.3 million was primarily due to sales and maturities of marketable securities of $44.4$24.4 million partially offset by purchases of marketable securities of $22.1 million.

During the six months ended June 30, 2019, net cash provided by investing activities of $21.3 million was due to sales and maturities of marketable securities of $70.6 million, partially offset by purchases of marketable securities of $49.2$5.4 million.

Financing Activities

During the sixthree months ended June 30,March 31, 2021, net cash provided by financing activities of $33.4 million was primarily due to proceeds of $28.1 million, net of issuance costs from the issuance of common stock and proceeds of $5.0 million from the issuance of debt.

During the three months ended March 31, 2020, net cash provided by financing activities of $34.8$34.9 million was primarily due to the proceeds from issuance of debt of $34.5 million, net of third-party fees and issuance costs.

Duringcosts from the six months ended June 30, 2019, net cash provided by financing activitiesissuance of $215,000 was the result of proceeds from exercises of common stock options.debt.

Funding Requirements

We expect our expenses to increase in connection with our ongoing activities, particularly as we continue the research and development of, continue or initiate clinical trials of, and seek marketing approval for, our product candidates. In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. Furthermore, we expect to incur additional costs associated with operating as a public company. Accordingly, we may need to obtain additional funding in connection with our continuing operations. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or future commercialization efforts.

We believe that our existing cash, cash equivalents, and marketable securities as of June 30, 2020March 31, 2021, combined with the $11.5 million up-front payment we received pursuant to the Torii Agreement in April 2021, will be sufficient to support our planned operations, at least through the fourthsecond quarter of 2021.2023. Our future capital requirements will depend on many factors, including:

 

the costs, timing and outcome of regulatory review of our product candidates;

 

the scope, progress, results and costs of our clinical trials;

 

the scope, prioritization and number of our research and development programs;

 

the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending intellectual property-related claims;

 

our ability to maintain compliance with covenants under our loan agreements;

 

the extent to which we acquire or in-license other product candidates and technologies;


 

the impact on the timing of our clinical trials and our business due to the COVID-19 pandemic;

 

the costs to scale up and secure manufacturing arrangements for commercial production; and

 

the costs of establishing or contracting for sales and marketing capabilities if we obtain regulatory approvals to market our product candidates.

Identifying potential product candidates and conducting preclinical studies and clinical trials is a time-consuming, expensive and uncertain process that takes many years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our commercial revenues, if any, will be derived from sales of a product candidate that we do not expect to be commercially available in the near term, if at all. We may not achieve significant revenue from product sales prior to the use of the net proceeds from our IPO. Accordingly, we may need to continue to rely on additional financing to achieve our business objectives. Adequate additional financing may not be available to us on acceptable terms, or at all.all.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. Our ability to raise additional capital may be adversely impacted by potential worsening global economic conditions and the recent disruptions to, and volatility in, the credit and financial markets in the United States and worldwide resulting from the ongoing COVID-19 pandemic. To the extent that we raise additional capital through the sale of equity or convertible debt securities, ownership interests of existing stockholders may be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our existing stockholders’ rights. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends.


If we raise funds through additional collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or to grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Off-Balance Sheet Arrangements

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

Contractual Obligations and Commitments

As of June 30, 2020,March 31, 2021, there have been no material changes to our contractual obligations and commitments as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019 except as discussed below.

On March 12, 2020 we entered into an amendment to the lease agreement dated July 1, 2019 for office space in West Chester, Pennsylvania.  The amendment expands the original premises to include 5,372 square feet of additional office space increasing the total rentable premise to 11,201 square feet of space.  For the first six months following the commencement date, the base rent is based on the square footage of the original premises.  We anticipate the commencement date to be during the third quarter of 2020 but may be delayed due to impacts of COVID-19 mandates on office building construction activities. The initial term will expire seven years after the commencement date. Base rent over the initial lease term is $2.4 million, and we are also responsible for our share of the landlord’s operating expense2020..

JOBS Act Transition Period

In April 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act 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. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

We are in the process of evaluating the benefits of relying on other exemptions and reduced reporting requirements under the JOBS Act. Subject to certain conditions, as an emerging growth company, we may rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an emerging growth company until the earlier to occur of (1) the last day of the fiscal year (a) December 31, 2023, which is the end of the fiscal year following the fifth anniversary of the completion of our IPO, (b) in which we have total annual gross revenues of at least $1.07 billion or (c) in which we are deemed to be a “large accelerated filer” under the rules of the U.S. Securities and Exchange Commission, which means the market value of our common stock that is held by non-affiliates exceeds $700 million as of the prior June 30th, andor (2) the date on which we have issued more than $1.0 billion in non-convertible debt during the prior three-year period.


Item 3.

Quantitative and Qualitative Disclosures About Market Risks

There have been no material changes to our quantitative and qualitative disclosures about market risk as previously disclosed in our Annual Report on Form 10-K for the fiscal year ended December 31, 20192020.

The uncertainty that exists with respect to the economic impact of the global COVID-19 pandemic has introduced significant volatility in the financial markets during and subsequent to our quarter ended June 30, 2020.


Item 4.

Controls and Procedures

Evaluation of Disclosure Controls and Procedures

The term “disclosureOur management, with the participation of our Chief Executive Officer and Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures” as (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange ActAct) as of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designedthe end of the period covered by this Quarterly Report on Form 10-Q to ensure that the information required to be disclosed by a companyus in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’sSEC rules and forms. Disclosure controlsforms, and procedures include, without limitation, controls and procedures designedthat information required to ensure that such informationbe disclosed in the reports we file or submit under the Exchange Act is accumulated and communicated to a company’sour management, including its principal executiveour Chief Executive Officer and principal financial officers, as appropriateChief Financial Officer, to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, managementdisclosures. Management recognizes that disclosureany controls and procedures, no matter how well conceiveddesigned and operated, can provide only reasonable not absolute, assurance that theof achieving their objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to applyapplies its judgment in evaluating the cost-benefitcost benefit relationship of possible controls and procedures. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that our disclosure controls and procedures. The designprocedures were effective at the reasonable assurance level as of March 31, 2021.

Disclosure Controls and Procedures

Management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act.

Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any systemevaluation of controls also is based in part upon certain assumptions abouteffectiveness to future periods are subject to the likelihood of future events, and there can be no assurancerisk that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.

As previously disclosed under “Item 9A. Controls and Procedures” in our Annual Report on Form 10-K for our fiscal year ended December 31, 2019, we identified the following deficiencies that existed as of December 31, 2019 and continued to exist at June 30, 2020. A material weakness is a control deficiency or a combination of control deficiencies that results in more than a remote likelihood that a material misstatement of the annual or interim financial statements will not be prevented or detected.

We identified a material weakness in our information technology (“IT”) general controls (collectively, “ITGCs”) and related IT-dependent process level controls, which are part of our internal control over financial reporting. Based on this evaluation, management identified a deficiency within our ITGCs related to ineffective segregation of duties within one of our IT systems, which is part of our internal control over financial reporting. Process-level controls that were dependent upon information derived from this IT system were also determined to be ineffective. These deficiencies were the result of an inadequate IT risk assessment process that did not identify the risks associated with ineffective segregation of duties within the IT system.

Because of the deficiencies noted above, in consultation with management, our principal executive officer and principal financial officer concluded that we did not maintain effective internal control over financial reporting and our disclosure controls and procedures were not effective as of both December 31, 2019 and June 30, 2020, based onManagement utilized the criteria established in the Internal Control – Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

Remediation to assess the effectiveness of Material Weakness

Our Board of Directors and management take internal control over financial reporting and the integrity of our financial statements seriously. We have taken steps to remediate the deficiency related to ineffective segregation of duties within this IT system in 2020 by transferring key administrative access to a third-party IT vendor in April 2020.  Management believes that this effort will remediate the material weakness. However, the material weakness in our internal control over financial reporting will not be considered remediated until other ITGCs and process-level controls that were dependent upon information derived from the general ledger application operate for a sufficient periodas of time and can be tested and concluded by management to be designed and operating effectively. We cannot provide any assurance that these remediation efforts will be successful or that our internal control over financial reporting will be effective as a result of these efforts. In addition, as we continue to evaluate and work to improve our internal control over financial reporting related to the identified material weakness, management may determine to take additional measures to address control deficiencies or determine to modify the remediation plan described above.

March 31, 2021.

Changes in Internal Control overOver Financial Reporting

Other than in connection with remediation plan outline above, there wereThere have been no changes in our internal control over financial reporting (as definedidentified in Rules 13a-15(f)connection with the evaluation required by Rule 13a-15(b) and 15d-15(f) under15d-15(b) of the Exchange Act)Act that occurred during the fiscal quarter ended June 30, 2020March 31, 2021 that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.reporting.


PART II. OTHER INFORMATION

Item 1.

On July 14, 2020, plaintiff Isaiah Potter, or Potter, filed a putative class action complaint captioned Potter v. Verrica Pharmaceuticals Inc.,From time to time, we may be subject to litigation and claims arising in the U.S. District Court for the Eastern Districtordinary course of Pennsylvaniabusiness. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against the Company and certain of its executive officers,us that we believe could have a material adverse effect on our business, operating results, cash flows or the Defendants.  The complaint alleges that Defendants violated federal securities laws by, among other things, failing to disclose certain supposed safety risks attendant to the VP-102 drug-device and likely delays to regulatory approval of VP-102.  The complaint seeks unspecified compensatory damages on behalf of Potter and all other persons and entities that purchased or otherwise acquired our securities between September 16, 2019 and June 29, 2020.  The Company disputes these claims and intends to defend the matter vigorously.  The Company cannot estimate the reasonably possible loss or range of loss that may result from this action, if any.  financial condition.

Item 1A.

Risk Factors

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. In addition to the other information set forth in this quarterly report on Form 10-Q, you should carefully consider the factors described in Part I, Item 1A. “Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2019,2020, filed with the Securities and Exchange Commission on March 13, 2020. Except as described below, there17, 2021. There have been no material changes to the risk factors described in that report.

 


In light of our receipt of a CRL from the FDA regarding our NDA for VP-102, the U.S. regulatory requirements and timing for VP-102 approval are uncertain, and we may never obtain regulatory approval in the United States.

Risks Factors Summary

 

In September 2019, we submitted an NDAOur business is subject to a number of risks and uncertainties, including those risks discussed below. These risks include, among others, the FDA for VP-102 for the treatment of molluscum. In July 2020, we received a CRL from the FDA for our NDA. The CRL indicated the need for additional information regarding certain aspects of the chemistry, manufacturing and controls, or CMC, process for the drug/device combination as well as human factors validation.  As a result, the approval of our NDA for VP-102 has been delayed and may never occur.

We plan to request a Type A meeting to discuss the issues that were described in the CRL and other matters pertaining to the steps required for the resubmission of the NDA for VP-102.  There can be no guarantee that the FDA will grant this request or, if granted, what the timing for holding the meeting will be.  We cannot predict the outcome of any interactions with the FDA nor can we guarantee when, or if, we will be successful in receiving regulatory approval for VP-102.

The U.S. regulatory requirements and timing for VP-102 approval are uncertain at this time, and we may never obtain regulatory approval of VP-102 or any of our other product candidates in the United States. If we do not obtain approval for VP-102 or are delayed in obtaining such approval, it would have a material adverse effect on our operations and financial condition.

COVID-19 has adversely impacted and could continue to adversely impact our business.

In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, COVID-19 has spread to multiple countries, including the United States.  As a direct result of COVID-19, we have decided to delay the initiation of our Phase 3 clinical trials to evaluate VP-102 in subjects with common warts as well as our planned Phase 2 clinical trial to evaluate VP-103 in subjects with plantar warts until conditions are appropriate.  As COVID-19 continues to rapidly evolve in the United States, we may experience continued and additional disruptions or impairments that could severely impact our business, supply chain, clinical trials, or ability to obtain regulatory approval for, or commercialize, VP-102, including:

following:

 

delaysRisks Related to Our Financial Position and Capital Needs

o

We have incurred significant losses since our inception. We expect to incur losses over the next several years and may never achieve or inability to obtain raw material, ingredients, or components;maintain profitability.

 

 

o

possible capacity constraints at key suppliersWe may need substantial additional funding to meet our financial obligations and service providersto pursue our business objectives. If we are unable to raise capital when needed, we could be forced to curtail our planned operations and the pursuit of our growth strategy.

o

We have a limited operating history and no history of commercializing products, which could impact process validation schedules or abilitymay make it difficult for you to build launch stock;evaluate the success of our business to date and to assess our future viability.

 

 

furtherRisks Related to the Development of Our Product Candidates

o

Our lead product candidate, VP-102, is being developed for the treatment of molluscum, common warts and external genital warts, for which we are currently conducting clinical trials. If we are unable to successfully develop, receive regulatory approval for and commercialize VP-102 for the treatment of molluscum, common warts, external genital warts or any other indications, or successfully develop any other product candidates, or experience significant delays or difficulties in enrolling patients indoing so, our clinical trials;business will be harmed.

 

 

further delays Risks Related to the Commercialization of Our Product Candidates

o

We face substantial competition, including from compounded cantharidin products that may compete with VP-102 and any other product candidates, which may result in a smaller than expected commercial opportunity and/or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;others discovering, developing or commercializing products before or more successfully than we do.

 

 

o

diversionThe success of healthcare resources away fromVP-102 for the conducttreatment of clinical trials, includingmolluscum and common warts will depend significantly on coverage and adequate reimbursement or the diversionwillingness of hospitals serving as our clinical trial sites and hospital staff supporting the conduct of our clinical trials;patients to pay for these procedures.


 

o

delays in review of regulatory filings by regulatory authorities or our ability to generate responses to the FDA inquiries per the CRL regarding our filed NDAThe market for VP-102;VP-102 and any other product candidates may not be as large as we expect.

 

 

delaysRisks Related to Our Dependence on Third Parties

o

We currently rely on a third party to supply our raw material used in VP-102, and if we encounter any extended difficulties in procuring, or limitationscreating an alternative for, our raw material in VP-102 or any of our ability to commercialize VP-102, regardless of regulatory approval, including challenges involving the healthcare providers whoother product candidates we may develop, our business operations would prescribe and administer VP-102, delays in launch preparation activities, or delays in establishing, and subsequently deploying, a commercial field force;be impaired.

 

 

o

limitationsWe have entered into, and may seek additional, collaborations with third parties for the development or commercialization of our product candidates. If those collaborations are not successful, we may not be able to capitalize on travelthe market potential of these product candidates.

Risks Related to Our Intellectual Property

o

If we are unable to obtain or accessprotect intellectual property rights related to third-party facilities imposed or recommended by federal or state governments, employers, suppliers, and others; andany of our product candidates, we may not be able to compete effectively in our market.

 

 

limitations of internalRisks Related to Legal and third-party employee resources that would otherwise be focused on the above activities, including sickness of employees or their families, travel restrictions or social distancing, or the desire of employees to avoid contact with large groups of people.Regulatory Compliance Matters

We are closely monitoring the situation and do not yet know the extent to which COVID-19 may materially impact our business, supply chain, clinical trials and regulatory filings, which will depend on future developments which are highly uncertain and cannot be predicted with confidence, such as the ultimate geographic spread of the disease, the duration of the outbreak, travel restrictions and social distancing in the United States and other countries, business closures or business disruptions and the effectiveness of actions taken in the United States and other countries to contain and treat the disease.

The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.

Our stock price may be volatile. The stock market in general and the market for biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the operating performance of particular companies. As a result of this volatility, investors may not be able to sell their common stock at or above the price paid for the shares. The market price for our common stock may be influenced by many factors, including:

 

o

the commencement, enrollment or results ofWe expect to expand our clinical trials of VP-102 for the treatment of common wartsdevelopment and external genital wartsregulatory capabilities and any future clinical trialspotentially implement sales, marketing and distribution capabilities, and as a result, we may conduct, or changesencounter difficulties in the development status ofmanaging our product candidates;growth, which could disrupt our operations.

 

 

any delay inRisks Related to Employee Matters and Managing Our Growth

o

We expect to expand our development and regulatory filings for VP-102 for the treatment of molluscum, including our planned resubmission of our NDA in response to the CRL we received in July 2020,capabilities and common warts or any other product candidatepotentially implement sales, marketing and distribution capabilities, and as a result, we may develop, including VP-103, and any adverse development or perceived adverse development with respect to the applicable regulatory authority’s review of such filings, including without limitation the FDA’s issuance of a “refusal to file” letter or a request for additional information;encounter difficulties in managing our growth, which could disrupt our operations.


 

 

adverse results from, delays in or terminationRisks Related to Ownership of clinical trials;Our Common Stock and Our Status as a Public Company

o

The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.

 

adverse regulatory decisions, including failure to receive regulatory approval of our product candidates, such as the CRL related to VP-102 for the treatment of molluscum that we received from the FDA in July 2020;

unanticipated serious safety concerns related to the use of VP-102 or any other product candidate;

changes in financial estimates by us or by any securities analysts who might cover our stock;

conditions or trends in our industry;

changes in the market valuations of similar companies;

stock market price and volume fluctuations of comparable companies and, in particular, those that operate in the biopharmaceutical industry;

publication of research reports about us or our industry or positive or negative recommendations or withdrawal of research coverage by securities analysts;


announcements by us or our competitors of significant acquisitions, strategic partnerships or divestitures;

announcements of investigations or regulatory scrutiny of our operations or lawsuits filed against us;

investors’ general perception of our company and our business;

recruitment or departure of key personnel;

overall performance of the equity markets;

trading volume of our common stock;

disputes or other developments relating to proprietary rights, including patents, litigation matters and our ability to obtain patent protection for our technologies;

significant lawsuits, including patent or stockholder litigation;

changes in the structure of healthcare payment systems;

general political and economic conditions; and

other events or factors, many of which are beyond our control.

In addition, in the past, stockholders have initiated class action lawsuits against pharmaceutical and biotechnology companies following periods of volatility in the market prices of these companies’ stock. For example, a purported class action complaint was filed against us and certain of our executive officers alleging violations of certain federal securities laws.  This case, and additional litigation, if instituted against us, could cause us to incur substantial costs and divert management’s attention and resources from our business.

Item 2.

Recent Sales of Unregistered Securities and Use of Proceeds

(a) Recent Sales of Unregistered Equity Securities

None.

(b) Use of Proceeds from Initial Public Offering of Common Stock

Not applicable.

(c) Issuer Purchases of Equity Securities

None.

Item 3.

Defaults Upon Senior Securities

None.

Item 4.

Mine Safety Disclosures

Not applicable.

Item 5.

Other Information

Not applicable.

Item 6.

Exhibits

 


EXHIBIT INDEX

 

Exhibit
No.

 

Description

 

 

 

3.1 (1)

  

Amended and Restated Certificate of Incorporation.

 

 

 

3.2 (2)

  

Amended and Restated Bylaws.

 

 

 

10.110.1+

 

Second Amendment to LeaseCollaboration and License Agreement, by and between the RegistrantCompany and 44 West Gay LLC,Torii Pharmaceutical Co., Ltd., dated as of April 27, 2020March 17, 2021 (filed herewith).

 

 

 

31.1

  

Certification of Chief Executive Officer and President (Principal Executive Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

 

 

 

31.2

  

Certification of Chief Financial Officer (Principal Financial Officer), pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 (filed herewith).

 

 

 

32.1*

  

Certifications of Chief Executive Officer and President (Principal Executive Officer) and Chief Financial Officer (Principal 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).

 

 

 

101101.INS

 

The following financial information fromInline XBRL Instance Document – the Company’s Quarterly Report on Form 10-Q forinstance document does not appear in the period ended June 30, 2020, formatted in Extensible Business Reporting Language (XBRL): (i)Interactive Data File because XBRL tags are embedded within the Condensed Balance Sheets, (ii)Inline XBRL document.

101.SCH

Inline XBRL Taxonomy Extension Schema Document

!01.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 (embedded within the Condensed Statements of Operations, (iii) the Condensed Statement of Stockholders’ Equity, (iv) the Condensed Statements of Cash Flows, and (v) Notes to the Condensed Financial Statements (filed herewith).Inline XBRL document)

 

(1)

Previously filed as Exhibit 3.3 to the Company’s Registration Statement on Form S-1 (File No. 333-225104), filed with the Securities and Exchange Commission on May 22, 2018, and incorporated herein by reference.

(2)

Previously filed as Exhibit 3.4 to the Company’s Registration Statement on Form S-1 (File No. 333-225104), filed with the Securities and Exchange Commission on May 22, 2018, and incorporated herein by reference.

+

Certain portions of this exhibit, indicated by asteriks, have been omitted pursuant to Item 601(b)(10) of Regulation S-K because they are not material and would likely cause competitive harm to the registrant if publicly disclosed.

*

These certifications are being furnished solely to accompany this quarterly report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing. 


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.

 

 

 

 

 

 

 

 

 

 

 

 

VERRICA PHARMACEUTICALS INC.

 

 

 

 

August 5, 2020May 7, 2021

 

 

 

By:

 

/s/ Ted White

 

 

 

 

 

 

Ted White

 

 

 

 

 

 

Chief Executive Officer and President

 

 

 

 

 

 

(Principal Executive Officer)

 

 

 

 

 

 

 

 

By:

 

/s/ A. Brian Davis

 

 

 

 

 

 

A. Brian Davis

 

 

 

 

 

 

Chief Financial Officer

 

 

 

 

 

 

(Principal Financial Officer)

 

27