10-Q 1 vrca-20240630.htm 10-Q 10-Q
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28

 

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, 2024

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.)

44 West Gay Street, Suite 400

West Chester, PA

19380

(Address of principal executive offices)

(Zip Code)

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

N/A

(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 August 8, 2024, the registrant had 42,668,553 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

 

15

 

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risks

 

25

 

 

 

 

 

Item 4.

 

Controls and Procedures

 

25

 

 

 

 

 

PART II. OTHER INFORMATION

 

 

 

 

 

 

 

Item 1.

 

Legal Proceedings

 

25

 

 

 

 

 

Item 1A.

 

Risk Factors

 

26

 

 

 

 

 

Item 5.

 

Other Information

 

27

 

 

 

 

 

Item 6.

 

Exhibits

 

27

 

 

 

 

 

Signatures

 

29

 

 

 


 

PART I. FINANCIAL INFORMATION

Item 1. Unaudited Financial Statements

VERRICA PHARMACEUTICALS INC.

BALANCE SHEETS

(in thousands, except share and per share amounts)

(unaudited)

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

31,930

 

 

$

69,547

 

Accounts receivable

 

 

10,026

 

 

 

4,248

 

Unbilled collaboration revenue

 

 

182

 

 

 

168

 

Inventory

 

 

2,704

 

 

 

1,022

 

Prepaid expenses and other current assets

 

 

2,476

 

 

 

2,545

 

    Total current assets

 

 

47,318

 

 

 

77,530

 

Property and equipment, net

 

 

710

 

 

 

1,052

 

Operating lease right-of-use asset

 

 

1,005

 

 

 

1,158

 

Finance lease right-of-use asset

 

 

2,524

 

 

 

1,405

 

Other non-current assets

 

 

453

 

 

 

452

 

Total assets

 

$

52,010

 

 

$

81,597

 

LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

1,150

 

 

$

2,464

 

Accrued expenses and other current liabilities

 

 

17,850

 

 

 

13,860

 

Operating lease liability

 

 

332

 

 

 

324

 

Finance lease liability

 

 

719

 

 

 

376

 

    Total current liabilities

 

 

20,051

 

 

 

17,024

 

Operating lease liability

 

 

744

 

 

 

910

 

Finance lease liability

 

 

1,764

 

 

 

1,026

 

Long-term debt

 

 

42,751

 

 

 

42,874

 

Total liabilities

 

 

65,310

 

 

 

61,834

 

Commitments and Contingencies (Note 6)

 

 

 

 

 

 

Stockholders’ (deficit) equity:

 

 

 

 

 

 

Preferred stock, $0.0001 par value; 10,000,000 shares authorized; no shares
 issued and outstanding as of June 30, 2024 and December 31, 2023

 

 

 

 

 

 

Common stock, $0.0001 par value; 200,000,000 authorized;
42,561,197 shares issued and 42,456,053 shares outstanding as of June 30, 2024 and 42,518,697 shares issued and 42,413,553 shares outstanding as of December 31, 2023

 

 

4

 

 

 

4

 

Treasury stock, at cost, 105,144 shares as of June 30, 2024 and December 31, 2023

 

 

 

 

 

 

Additional paid-in capital

 

 

254,661

 

 

 

250,207

 

Accumulated deficit

 

 

(267,965

)

 

 

(230,448

)

Total stockholders’ (deficit) equity

 

 

(13,300

)

 

 

19,763

 

Total liabilities and stockholders’ (deficit) equity

 

$

52,010

 

 

$

81,597

 

 

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

1


 

VERRICA PHARMACEUTICALS INC.

STATEMENTS OF OPERATIONS

(in thousands, except share and per share amounts)

(Unaudited)

 

 

For the Three Months Ended

 

 

For the Six Months Ended

 

 

 

June 30,

 

 

June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenue, net

 

$

4,892

 

 

$

 

 

$

8,124

 

 

$

 

Collaboration revenue

 

 

285

 

 

 

182

 

 

 

879

 

 

 

219

 

Total revenue

 

 

5,177

 

 

 

182

 

 

 

9,003

 

 

 

219

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Selling, general and administrative

 

 

16,522

 

 

 

5,937

 

 

 

32,861

 

 

 

10,256

 

Research and development

 

 

3,319

 

 

 

5,725

 

 

 

8,267

 

 

 

8,464

 

Cost of product revenue

 

 

360

 

 

 

 

 

 

906

 

 

 

 

Cost of collaboration revenue

 

 

182

 

 

 

136

 

 

 

774

 

 

 

204

 

Total operating expenses

 

 

20,383

 

 

 

11,798

 

 

 

42,808

 

 

 

18,924

 

Loss from operations

 

 

(15,206

)

 

 

(11,616

)

 

 

(33,805

)

 

 

(18,705

)

Other (expense) income:

 

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

 

393

 

 

 

626

 

 

 

991

 

 

 

1,126

 

Interest expense

 

 

(2,368

)

 

 

 

 

 

(4,687

)

 

 

 

Other expense

 

 

(5

)

 

 

 

 

 

(16

)

 

 

 

Total other (expense) income, net

 

 

(1,980

)

 

 

626

 

 

 

(3,712

)

 

 

1,126

 

Net loss

 

$

(17,186

)

 

$

(10,990

)

 

$

(37,517

)

 

$

(17,579

)

 

 

 

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(0.37

)

 

$

(0.24

)

 

$

(0.81

)

 

$

(0.40

)

Weighted-average common shares outstanding, basic and diluted

 

 

46,502,274

 

 

 

45,916,867

 

 

 

46,492,971

 

 

 

44,478,116

 

 

 

 

 

 

 

 

 

 

 

 

 

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

2


 

VERRICA PHARMACEUTICALS INC.

STATEMENTS OF STOCKHOLDERS’ (DEFICIT) EQUITY

(in thousands, except share amounts)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Total

 

 

 

Common Stock

 

 

Additional

 

 

Subscription

 

 

Accumulated

 

 

Treasury Stock

 

 

Stockholders’

 

 

 

Shares Issued

 

 

Amount

 

 

Paid-in Capital

 

 

Receivable

 

 

Deficit

 

 

Shares

 

 

Cost

 

 

(Deficit) Equity

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 January 1, 2024

 

 

42,518,697

 

 

$

4

 

 

$

250,207

 

 

$

 

 

$

(230,448

)

 

 

105,144

 

 

$

 

 

$

19,763

 

 Stock-based compensation

 

 

 

 

 

 

 

 

2,072

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,072

 

 Exercise of stock options

 

 

6,500

 

 

 

 

 

 

8

 

 

 

(4

)

 

 

 

 

 

 

 

 

 

 

 

4

 

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(20,331

)

 

 

 

 

 

 

 

 

(20,331

)

 March 31, 2024

 

 

42,525,197

 

 

$

4

 

 

$

252,287

 

 

$

(4

)

 

$

(250,779

)

 

 

105,144

 

 

$

 

 

$

1,508

 

Stock-based compensation

 

 

 

 

 

 

 

 

2,228

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,228

 

Exercise of stock options

 

 

36,000

 

 

 

 

 

 

146

 

 

 

4

 

 

 

 

 

 

 

 

 

 

 

 

150

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(17,186

)

 

 

 

 

 

 

 

 

(17,186

)

June 30, 2024

 

 

42,561,197

 

 

$

4

 

 

$

254,661

 

 

$

 

 

$

(267,965

)

 

 

105,144

 

 

$

 

 

$

(13,300

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 January 1, 2023

 

 

41,199,197

 

 

$

4

 

 

$

203,482

 

 

$

 

 

$

(163,453

)

 

 

105,144

 

 

$

 

 

$

40,033

 

 Stock-based compensation

 

 

 

 

 

 

 

 

1,094

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,094

 

 Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs

 

 

750,000

 

 

 

 

 

 

30,301

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

30,301

 

 Exercise of stock options

 

 

8,000

 

 

 

 

 

 

7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

7

 

 Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,589

)

 

 

 

 

 

 

 

 

(6,589

)

 March 31, 2023

 

 

41,957,197

 

 

$

4

 

 

$

234,884

 

 

$

 

 

$

(170,042

)

 

 

105,144

 

 

$

 

 

$

64,846

 

Stock-based compensation

 

 

 

 

 

 

 

 

1,544

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,544

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,990

)

 

 

 

 

 

 

 

 

(10,990

)

June 30, 2023

 

 

41,957,197

 

 

$

4

 

 

$

236,428

 

 

$

 

 

$

(181,032

)

 

 

105,144

 

 

$

 

 

$

55,400

 

 

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

3


 

VERRICA PHARMACEUTICALS INC.

STATEMENTS OF CASH FLOWS

(in thousands)

(Unaudited)

 

 

For the Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(37,517

)

 

$

(17,579

)

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

 

 

 

 

 

 

Stock-based compensation

 

 

4,300

 

 

 

2,638

 

Depreciation expense

 

 

227

 

 

 

266

 

Non-cash interest expense

 

 

999

 

 

 

 

Loss on disposal of fixed assets

 

 

141

 

 

 

 

Amortization of operating lease right-of-use asset

 

 

153

 

 

 

143

 

Amortization of finance lease right-of-use asset

 

 

294

 

 

 

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other assets

 

 

(1,612

)

 

 

2,891

 

Collaboration revenue receivable, billed and unbilled

 

 

(15

)

 

 

314

 

Accounts receivable

 

 

(5,777

)

 

 

 

Accounts payable

 

 

(1,330

)

 

 

1,502

 

Accrued expenses and other current liabilities

 

 

3,990

 

 

 

713

 

Operating lease liability

 

 

(158

)

 

 

(147

)

Net cash used in operating activities

 

 

(36,305

)

 

 

(9,259

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

(11

)

 

 

(70

)

Net cash used in investing activities

 

 

(11

)

 

 

(70

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from exercise of stock options

 

 

154

 

 

 

7

 

Payment of debt amendment fees

 

 

(1,122

)

 

 

 

Repayment of finance lease

 

 

(333

)

 

 

 

Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs

 

 

 

 

 

30,301

 

Payment of equity issuance costs

 

 

 

 

 

(112

)

Net cash (used in) provided by financing activities

 

 

(1,301

)

 

 

30,196

 

Net (decrease) increase in cash and cash equivalents

 

 

(37,617

)

 

 

20,867

 

Cash and cash equivalents at the beginning of the period

 

 

69,547

 

 

 

34,273

 

Cash and cash equivalents at the end of the period

 

$

31,930

 

 

$

55,140

 

 

 

 

 

 

 

 

Supplemental disclosure of noncash investing and financing activities:

 

 

 

 

 

 

Property and equipment purchases in accounts payable or accrued expenses and other current liabilities at period end

 

$

14

 

 

$

 

Cash paid for interest

 

$

3,688

 

 

$

 

Right-of-use asset obtained in exchange for lease obligation

 

$

1,413

 

 

$

 

 

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

4


 

 

VERRICA PHARMACEUTICALS INC.

Notes to Financial Statements

(Unaudited)

Note 1—Organization and Description of Business Operations

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 developing and selling medications for skin diseases requiring medical intervention. On July 21, 2023, the U.S. Food and Drug Administration (“FDA”) approved YCANTH (VP-102) topical solution for the treatment of molluscum contagiosum in adult and pediatric patients two years of age and older. The Company launched commercial operations in August 2023.

Liquidity

The Company has incurred substantial operating losses since inception and expects to continue to incur significant losses for the foreseeable future and may never become profitable. As of June 30, 2024, the Company had an accumulated deficit of $268.0 million. The Company believes its cash, and cash equivalents of $31.9 million as of June 30, 2024 will be sufficient to support the Company’s planned operations only into the first quarter of 2025. These factors cause substantial doubt to exist about the Company's ability to continue as a going concern within one year after the date these financial statements are issued. The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.

The Company plans to secure additional capital in the future through equity or debt financings, partnerships, or other sources to carry out the Company’s planned commercial and development activities. If the Company is unable to raise capital when needed or on attractive terms, the Company would be forced to delay, reduce or eliminate continued commercialization efforts or research and development programs.

On July 26, 2023, the Company entered into a Credit Agreement which provides for up to $125.0 million in debt under a Loan Facility (as defined in Note 10). The Company borrowed $50.0 million under the Loan Facility on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. In addition, subject to the Company's achievement of certain revenue targets, up to $25.0 million could have been made available on or prior to June 30, 2024, up to $30.0 million would be made available on or prior to December 31, 2024, up to $10.0 million would be made available on or prior to March 31, 2025, and up to $10.0 million would be made available on or prior to June 30, 2025. The Company did not achieve the revenue target as of June 30, 2024 and was not able to borrow the first additional tranche of $25.0 million. In addition, the Company does not believe it will be able to borrow, and does not intend to borrow, additional tranches under the Credit Agreement. Amounts borrowed under the Loan Facility will mature on July 26, 2028.

Note 2—Significant Accounting Policies

Basis of Presentation

The accompanying unaudited interim 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 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, 2023 included in its Form 10-K, filed with the Securities and Exchange Commission (the “SEC”) on February 29, 2024. 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.

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 revenues and expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of revenues and expenses that are

5


 

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.

Collateral Cash

Cash and cash equivalents as of June 30, 2024 includes a cash deposit of $0.5 million with Bank of America as required under the Commercial Credit Card Program with a balance equal to the outstanding credit limit on commercial credit cards.

Fair Value of Financial Instruments and Credit Risk

As of June 30, 2024, the Company’s financial instruments included cash equivalents, accounts receivable, accounts payable, and notes payable. The carrying amount of cash equivalents, accounts receivable and accounts payable approximated fair value, given their short-term nature. The carrying value of the notes payable approximates fair value as the interest rate is reflective of current market rates on debt with similar terms and conditions.

Cash equivalents subject the Company to concentrations of credit risk. However, the Company invests its cash in accordance with a policy objective that seeks to ensure both liquidity and safety of principal. The policy limits investments to instruments issued by the U.S. government, certain SEC registered money market funds that invest only in U.S. government obligations and various other low-risk liquid investment options, and places restrictions on portfolio maturity terms.

Accounts receivable subjects the Company to concentrations of credit risk as all of the Company's revenue is from sales of a single product, YCANTH (VP-102), to several pharmaceutical wholesalers/distributors.

Accounts Receivable

Accounts receivable, related to YCANTH (VP-102) sales, was $10.0 million at June 30, 2024. As of June 30, 2024, the Company had no allowance for credit losses. An allowance for credit losses is determined based on the Company's assessment of the creditworthiness and financial condition of its customers, aging of receivables, as well as the general economic environment. Any allowance would reduce the net receivables to the amount that is expected to be collected. Current payment terms for YCANTH (VP-102) range from 30 to 90 days from the shipment date.

Inventory

The Company values inventory at the lower of cost or net realizable value. Inventory cost is determined using the specific identification method. The Company regularly reviews its inventory quantities and, when appropriate, records a provision for obsolete and excess inventory to derive the new cost basis, which takes into account the Company’s sales forecast and corresponding expiry dates. The Company has not recognized a provision for obsolete and excess inventory as of June 30, 2024.

On July 21, 2023, the Company received FDA approval for YCANTH (VP-102) for the treatment of molluscum contagiosum and began capitalizing inventory purchases of saleable product from certain suppliers. Prior to FDA approval, all product purchased from such suppliers was included as a component of research and development expense, as the Company was unable to assert that the inventory had future economic benefit until YCANTH received FDA approval. Pursuant to the supply agreement (Note 6), the Company purchased and included in research and development expenses approximately $4.5 million of raw cantharidin and processed active pharmaceutical ingredient ("API"). The raw cantharidin and processed API is sufficient to produce approximately 14.0 million finished drug product applicators to be used for commercially saleable product and other product candidates. In addition, the Company purchased other components and services related to YCANTH for commercially saleable product and included approximately $1.2 million in research and development expenses prior to FDA approval. As a result, cost of product revenue related to YCANTH will initially reflect a lower average per unit cost of materials over approximately the next ten months as previously expensed inventory is utilized for commercial production and sold to customers. If the Company were to have included those costs previously expensed as a component of cost of product revenue, the Company’s cost of product revenue for the three and six months ended June 30, 2024 would have been $0.7 million and $1.4 million, respectively, including $0.2 million of obsolete inventory costs for each period.

Product Revenue, Net

The Company recognizes revenue from sales of a single product, YCANTH (VP-102) (the “Product”) in accordance with ASC Topic 606 – Revenue from Contracts with Customers. YCANTH (VP-102) became available for commercial sale and shipment to patients with a prescription in the United States in the third quarter of 2023. The Company sells the Product to several customers, who are pharmaceutical wholesalers/distributors (the “Customers”) who in turn sell the Product directly to clinics, hospitals, and federal healthcare programs. Revenue is recognized as the Product is physically delivered to the Customers.

Gross product sales are reduced by corresponding gross-to-net (“GTN”) estimates using the expected value method, resulting in the Company’s reported “Product revenue, net” in the accompanying statements of operations. Product revenue, net reflects the amount the Company ultimately expects to realize in net cash proceeds, taking into account the current period gross sales and related cash receipts and the subsequent cash disbursements on these sales that the Company estimates for the various GTN categories discussed below. The GTN estimates are based upon information received from external sources, such as written or oral information obtained from our customers with respect to their period-end inventory levels and sales to end-users during the period, in combination

6


 

with management’s informed judgments. Due to the inherent uncertainty of these estimates, the actual amount of product returns, government chargebacks, prompt pay discounts, commercial rebates, Medicaid rebates, co-pay assistance and distribution, data, and group purchasing organizations ("GPO") administrative fees may be materially above or below the amount estimated. Variance between actual amounts and estimated amounts may result in prospective adjustments to reported net product revenue.

Each of the GTN estimate categories are discussed below:

Product Returns Allowances: The Customers are contractually permitted to return purchased Product in certain circumstances. The Company estimates expected returns based on the Company’s review of similar products in the industry. As historical data for returns of the Product becomes available over time, the Company will utilize historical return rates of the Product in making its estimates. Returned Product is typically destroyed, since substantially all returns are due to expiry and cannot be resold.

Government Chargebacks: The Product is subject to pricing limits under certain federal government programs, including Medicare and the 340B drug pricing program. Qualifying entities (the “End-Users”) purchase the Product from the Customers at their applicable qualifying discounted price. The chargeback amount the Company incurs represents the difference between the Company’s contractual sales price to the Customers and the end-user’s applicable discounted purchase price under the government program.

Medicaid Rebates: The Product is subject to state government-managed Medicaid programs, whereby rebates are issued to participating state governments. These rebates arise when a patient treated with the Product is covered under Medicaid, resulting in a discounted price for the Product under the applicable Medicaid program. The Medicaid rebate accrual calculations require the Company to project the magnitude of its sales, by state, that will be subject to these rebates.

Patient Assistance: The Company offers a voluntary co-pay patient assistance program intended to provide financial assistance to eligible patients with a prescription drug co-payment required by payors and coupon programs for cash payors. The calculation of the current liability for this assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with YCANTH (VP-102) that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period.

Distribution, Data, and GPO Administrative Fees: Distribution, data, and GPO administrative fees are paid to authorized wholesalers/distributors of the Company’s products for various commercial services including contract administration, inventory management, delivery of end-user sales data, and product returns processing. These fees are based on a contractually-determined percentage of the Company’s applicable sales.

Cost of Product Revenue

Cost of product revenue includes the cost of inventory sold, which includes direct manufacturing, production and packaging materials for YCANTH (VP-102) sales. Prior to FDA approval of YCANTH (VP-102) in July 2023, the Company expensed costs associated with manufacturing of YCANTH (VP-102) as a component of research and development expense that would have been included in cost of goods sold in the amount of $0.4 and $0.5 million for the three and six month period ending June 30, 2024, respectively, including $0.2 million of obsolete inventory costs for each period. Therefore, these costs are not included in cost of product revenue.

Advertising Expense

Advertising expenses, comprised primarily of print and digital assets, social media and internet advertising as well as search engine marketing, are expensed as incurred and are included in selling, general, and administrative expenses. For the three and six months ended June 30, 2024, advertising expense was approximately $1.1 million and $2.6 million, respectively.

Net Loss Per 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 including pre-funded warrants to purchase shares of common stock that were issued in an underwritten offering in February 2023 (Note 7). The pre-funded warrants to purchase common stock are included in the calculation of basic and diluted net loss per share as the exercise price of $0.0001 per share is non-substantive and is virtually assured. Diluted net loss per share excludes the potential impact of common stock options, unvested shares of restricted stock and warrants that the Company has issued to OrbiMed and Torii Pharmaceutical Co., Ltd. ("Torii") 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.

7


 

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:

 

 

 

June 30,

 

 

 

2024

 

 

2023

 

Shares issuable upon exercise of stock options

 

 

6,656,521

 

 

 

5,100,315

 

Non-vested shares under restricted stock grants

 

 

834,000

 

 

 

1,123,000

 

Shares issuable upon exercise of warrants pursuant to debt financing

 

 

518,551

 

 

 

 

Shares issuable upon exercise of warrants pursuant to Torii amendment

 

 

500,000

 

 

 

 

Total

 

 

8,509,072

 

 

 

6,223,315

 

 

 

 

Note 3 —Inventory

Upon FDA approval of YCANTH (VP-102) for the treatment of molluscum contagiosum on July 21, 2023, the Company began capitalizing the purchases of saleable inventory of YCANTH (VP-102) from suppliers. Inventory consisted of the following (in thousands):

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Raw materials

 

$

1,149

 

 

$

420

 

Work in process

 

 

683

 

 

 

487

 

Finished goods

 

 

872

 

 

 

115

 

Total inventory

 

$

2,704

 

 

$

1,022

 

 

Note 4—Property and Equipment

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

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2024

 

 

2023

 

Machinery and equipment

 

$

1,231

 

 

$

1,543

 

Office equipment

 

 

326

 

 

 

326

 

Office furniture and fixtures

 

 

303

 

 

 

303

 

Leasehold improvements

 

 

54

 

 

 

54

 

 

 

1,914

 

 

 

2,226

 

Accumulated depreciation

 

 

(1,204

)

 

 

(1,174

)

Total property and equipment, net

 

$

710

 

 

$

1,052

 

Depreciation expense for both of the three months ended June 30, 2024 and 2023 was $0.1 million. Depreciation expense for the six months ended June 30, 2024 and 2023 was $0.2 and $0.3 million, respectively.

Note 5—Accrued Expenses and Other Current Liabilities

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

 

 

June 30,
2024

 

 

December 31,
2023

 

Gross to net reserves

 

$

12,530

 

 

$

5,357

 

Compensation and related costs

 

 

2,337

 

 

 

3,438

 

Professional fees

 

 

1,454

 

 

 

1,423

 

Clinical trials and drug development

 

 

796

 

 

 

2,767

 

Commercial-related costs

 

 

339

 

 

 

538

 

Other current liabilities

 

 

301

 

 

 

244

 

Machinery and equipment

 

 

93

 

 

 

93

 

Total accrued expenses and other current liabilities

 

$

17,850

 

 

$

13,860

 

 

8


 

Note 6—Commitments and Contingencies

Litigation

On June 6, 2022, plaintiff Kranthi Gorlamari (“Plaintiff”) filed a putative class action complaint captioned Gorlamari v. Verrica Pharmaceuticals Inc., et al., in the U.S. District Court for the Eastern District of Pennsylvania against us and certain of our current and former officers and directors (“Defendants”). On January 12, 2023, the Plaintiff filed an amended complaint alleging that Defendants violated federal securities laws by, among other things, failing to disclose certain manufacturing deficiencies at the facility where our contract manufacturer produced bulk solution for the YCANTH (VP-102) drug device and that such deficiencies posed a risk to the prospects for regulatory approval of YCANTH (VP-102) for the treatment of molluscum. The amended complaint seeks unspecified compensatory damages and other relief on behalf of Plaintiff and all other persons and entities which purchased or otherwise acquired our securities between May 19, 2021 and May 24, 2022 (the “Putative Class Period”).

On January 12, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the amended complaint. The Court held that Plaintiff’s claims relating to statements made in May and June 2021 were sufficiently pled, but dismissed Plaintiff’s claims relating to all other statements made during the Putative Class Period. On January 26, 2024, Plaintiff filed a second amended complaint in an attempt to cure certain of the deficiencies identified in the January 12, 2024 ruling. Defendants’ motion to dismiss the second amended complaint was fully briefed as of April 22, 2024, and is pending before the Court.

In February 2024, the Company filed a lawsuit in the Eastern District of Pennsylvania against Dormer Laboratories Inc. ("Dormer Labs"), a Canadian Drug Manufacturer, requesting, among other relief, that the court enjoin Dormer Labs from marketing, selling, and distributing drugs containing cantharidin in the United States, as well as compensatory, statutory and punitive damages for Dormer Labs’ violations of the federal Lanham Act and Pennsylvania law.

In June 2024, the Company and Dormer Labs announced the settlement of litigation. As part of the settlement, Dormer Labs discontinued the sale of all cantharidin-containing products in the United States and also, provided the Company with Dormer’s customer list in exchange for $0.8 million, of which $0.4 million was due upfront and the remaining $0.4 million is due in December 2024. The Company expensed the $0.8 million for the three and six months ended June 30, 2024 in the statement of operations as a settlement of litigation. The Company also recorded a liability for the remaining $0.4 million due in December 2024, as the Company is contractually obligated to pay this amount solely based on the passage of time. The $0.4 million is included in accrued expenses and other liabilities on the balance sheet as of June 30, 2024.

The Company is also 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.

Supply Agreement and Purchase Order

On July 16, 2018, the Company entered into a supply agreement with a supplier of crude cantharidin material. All executed purchase orders for crude cantharidin in the ordinary course of business are expected to be covered under the terms of the supply agreement. Pursuant to the supply agreement, the supplier has agreed that it will not supply cantharidin, any beetles or other raw material from which cantharidin is derived to any other customer in North America, subject to specified minimum annual purchase orders and forecasts by the Company. The supply agreement had an initial five-year term, and now renews for successive annual periods absent termination by either party in accordance with the terms of the supply agreement. Each party also has the right to terminate the supply agreement for other customary reasons such as material breach or bankruptcy.

In 2023, the Company executed a purchase order pursuant to which the Company agreed to purchase $0.7 million of crude cantharidin material and made a prepayment of $0.7 million against the purchase order. The Company received the shipment for the 2023 purchase during the first quarter of 2024, which was reflected as a prepaid expense of $0.7 million on the balance sheet as of December 31, 2023.

 

Note 7—Stockholders’ Equity

Common Stock

The Company had authorized 200,000,000 shares of common stock, $0.0001 par value per share, as of June 30, 2024 and December 31, 2023. Each share of common stock is entitled to one vote. Common stock owners are entitled to dividends when funds are legally available and declared by the Board.

Underwritten Public Offering

In February 2023, the Company closed an underwritten offering of 750,000 shares of its common stock and pre-funded warrants to purchase 4,064,814 shares of common stock. The shares of common stock were sold at a price of $6.75 per share and the pre-funded warrants were sold at a price of $6.7499 per pre-funded warrant, resulting in net proceeds of $30.3 million after deducting

9


 

underwriting discounts and commissions, and offering expense. The pre-funded warrants will not expire and are exercisable in cash or by means of a cashless exercise.

Warrants

The following table summarizes the Company’s outstanding warrants, all of which are exercisable for common stock:

 

 

June 30, 2024

 

 

Number of warrants

 

 

Exercise Price

 

 

Expiration Date

Pre-funded warrants issued pursuant to 2023 underwritten public offering

 

 

4,064,814

 

 

$

0.0001

 

 

No expiration

Warrants issued in connection with OrbiMed debt facility

 

 

518,551

 

 

$

6.0264

 

 

7/25/2033

Warrants issued in connection with Torii amendment

 

 

500,000

 

 

$

9.5600

 

 

5/14/2034

 

Note 8—Stock-Based Compensation

Stock-based compensation expense, which includes expense for both options and restricted stock units, has been reported in the Company’s statements of operations as follows (in thousands):

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Selling, general and administrative

 

$

1,715

 

 

$

950

 

 

$

3,337

 

 

$

1,785

 

Research and development

 

 

513

 

 

 

594

 

 

 

963

 

 

 

853

 

Total stock-based compensation

 

$

2,228

 

 

$

1,544

 

 

$

4,300

 

 

$

2,638

 

 

Stock Options

The following table summarizes the Company’s stock option activity for the six months ended June 30, 2024:

 

 

 

 

 

 

 

 

Weighted average

 

 

 

 

 

 

 

 

 

Weighted average

 

 

remaining contractual

 

 

Aggregate intrinsic

 

 

 

Number of shares

 

 

exercise price

 

 

term (in years)

 

 

value

 

Outstanding as of December 31, 2023

 

 

5,565,615

 

 

$

8.25

 

 

 

7.2

 

 

$

4,143,150

 

Granted

 

 

1,228,700

 

 

$

5.40

 

 

 

 

 

 

 

Exercised

 

 

(42,500

)

 

$

3.62

 

 

 

 

 

$

207,665

 

Forfeited

 

 

(95,294

)

 

$

6.12

 

 

 

 

 

 

 

Outstanding as of June 30, 2024

 

 

6,656,521

 

 

$

7.74

 

 

 

7.1

 

 

$

6,260,166

 

Options vested and exercisable as of
   June 30, 2024

 

 

3,650,897

 

 

$

8.99

 

 

 

5.6

 

 

$

1,849,369

 

As of June 30, 2024, the total unrecognized compensation related to unvested stock option awards granted was $13.7 million, which the Company expects to recognize over a weighted-average period of 2.77 years.

Restricted Stock Units

 

In November 2019 and August 2020 the Company granted 300,000 and 250,000 restricted stock units ("RSUs"), respectively, to its executive officers, of which 125,000 were forfeited. Half of the remaining RSUs vested upon receipt of regulatory approval of the Company’s new drug application for YCANTH (VP-102) for the treatment of molluscum on July 21, 2023 (the “Approval Date”) and the other half vested on July 21, 2024.

 

In March 2023, the Company granted 698,000 RSUs, half of which vested upon the first commercial sale of YCANTH (VP-102) on August 24, 2023 and half of which will vest on August 24, 2024, subject to the holders’ continuous service through each applicable date.

 

In March 2024, the Company granted 272,500 RSUs to executive officers. These restricted stock units vest 25% annually over four years subject to the holders' continuous service through each applicable date.

 

Compensation expense was recognized in the Company’s statements of operations related to the vested RSUs based on the fair market value at the date of grant. As of June 30, 2024, the remaining unrecognized compensation expense related to the RSUs was $1.6 million, which the Company expects to recognize over a weighted average service period of 1.6 years now that vesting of these awards is probable.

 

The following is a summary of changes in the status of non-vested RSUs for the six months ended June 30, 2024:

 

10


 

 

 

 

 

 

Weighted Average

 

 

 

 

 

 

Grant Date Fair

 

 

 

Number of Shares

 

 

Value

 

Nonvested as of December 31, 2023

 

 

561,500

 

 

$

9.13

 

Granted

 

 

272,500

 

 

 

4.80

 

Nonvested as of June 30, 2024

 

 

834,000

 

 

$

7.72

 

 

Note 9—Leases

The Company leases 11,201 square feet of office space located in West Chester, Pennsylvania that serves as the Company’s headquarters. The initial term expires 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.

The Company leases office space in Scotch Plains, New Jersey under an agreement classified as an operating lease, which commenced on May 1, 2022 and expires on April 30, 2025. Base rent over the initial term is approximately $104,000 per year.

The Company entered into a fleet program to provide vehicles for its sales force. The vehicles are leased for a term of 52 months and classified as finance leases. During the six months ended June 30, 2024, the Company recognized both a right-of-use asset and a lease liability of $1.4 million related to these finance leases.

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

 

 

 

For the Three Months Ended June 30,

 

 

For the Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 Finance lease cost:

 

 

 

 

 

 

 

 

 

 

 

 

Amortization ROU assets

 

$

156

 

 

$

 

 

$

294

 

 

$

 

Interest on lease liabilities

 

 

46

 

 

 

 

 

 

90

 

 

 

 

Total finance lease costs

 

$

202

 

 

$

 

 

$

384

 

 

$

 

Operating lease:

 

 

 

 

 

 

 

 

 

 

 

 

Operating lease costs

 

$

97

 

 

$

35

 

 

$

194

 

 

$

71

 

Total operating lease expense

 

$

97

 

 

$

35

 

 

$

194

 

 

$

71

 

Maturities of the Company’s operating and finance leases, excluding short-term leases, as of June 30, 2024 are as follows (in thousands):