Verrica Pharmaceuticals Inc
For the period ended Sep 30, 2024. Filed Nov 5, 2024.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2024 · Filed Nov 5, 2024
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Item 1. Financial Statements (Unaudited)
BALANCE SHEETS
(in thousands, except share and per share amounts)
(unaudited)
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| ASSETS | ||
| Current assets: | ||
| Cash and cash equivalents | $22,959 | $69,547 |
| Accounts receivable | — | 4,248 |
| Unbilled collaboration revenue | 84 | 168 |
| Inventory | 2,584 | 1,022 |
| Prepaid expenses and other current assets | 2,560 | 2,545 |
| Total current assets | 28,187 | 77,530 |
| Property and equipment, net | 651 | 1,052 |
| Operating lease right-of-use asset | 912 | 1,158 |
| Finance lease right-of-use asset | 2,639 | 1,405 |
| Other non-current assets | 538 | 452 |
| Total assets | $32,927 | $81,597 |
| LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY | ||
| Current liabilities: | ||
| Accounts payable | $966 | $2,464 |
| Accrued expenses and other current liabilities | 18,899 | 13,860 |
| Operating lease liability | 315 | 324 |
| Finance lease liability | 846 | 376 |
| Total current liabilities | 21,026 | 17,024 |
| Operating lease liability | 665 | 910 |
| Finance lease liability | 1,982 | 1,026 |
| Long-term debt | 43,305 | 42,874 |
| Total liabilities | 66,978 | 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 September 30, 2024 and December 31, 2023 | — | — |
| Common stock, $0.0001 par value; 200,000,000 authorized; 45,705,939 shares issued and 45,600,795 shares outstanding as of September 30, 2024 and 42,518,697 shares issued and 42,413,553 shares outstanding as of December 31, 2023 | 5 | 4 |
| Treasury stock, at cost, 105,144 shares as of September 30, 2024 and December 31, 2023 | — | — |
| Additional paid-in capital | 256,769 | 250,207 |
| Accumulated deficit | (290,825) | (230,448) |
| Total stockholders’ (deficit) equity | (34,051) | 19,763 |
| Total liabilities and stockholders’ (deficit) equity | $32,927 | $81,597 |
STATEMENTS OF OPERATIONS
(in thousands, except share and per share amounts)
| For the Three Months Ended · For the Nine Months Ended | ||||
|---|---|---|---|---|
| September 30, | September 30, | |||
| 2024 | 2023 | 2024 | 2023 | |
| Revenue: | ||||
| Product revenue, net | $(1,865) | $2,792 | $6,259 | $2,792 |
| Collaboration revenue | 84 | 125 | 963 | 344 |
| Total revenue | (1,781) | 2,917 | 7,222 | 3,136 |
| Operating expenses: | ||||
| Selling, general and administrative | 16,083 | 20,054 | 48,943 | 30,310 |
| Research and development | 2,405 | 6,510 | 10,673 | 14,975 |
| Cost of product revenue | 351 | 145 | 1,257 | 145 |
| Cost of collaboration revenue | 84 | 125 | 858 | 329 |
| Total operating expenses | 18,923 | 26,834 | 61,731 | 45,759 |
| Loss from operations | (20,704) | (23,917) | (54,509) | (42,623) |
| Other (expense) income: | ||||
| Interest income | 221 | 822 | 1,212 | 1,948 |
| Interest expense | (2,376) | (1,657) | (7,063) | (1,657) |
| Other expense | (1) | (50) | (17) | (49) |
| Total other (expense) income, net | (2,156) | (885) | (5,868) | 242 |
| Net loss | $(22,860) | $(24,802) | $(60,377) | $(42,381) |
| Net loss per share, basic and diluted | $(0.49) | $(0.54) | $(1.30) | $(0.94) |
| Weighted-average common shares outstanding, basic and diluted | 46,805,427 | 46,073,932 | 46,597,883 | 45,015,900 |
STATEMENTS OFSTOCKHOLDERS’ (DEFICIT) EQUITY
(in thousands, except share amounts)
| Total | |||||||
|---|---|---|---|---|---|---|---|
| Common Stock · Additional · Subscription · Accumulated · Treasury Stock · Stockholders’ | |||||||
| Shares Issued | Amount | Paid-in Capital | Receivable | Deficit | Shares | (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) |
| Stock-based compensation | — | — | 2,108 | — | — | — | 2,108 |
| Vesting of restricted stock units | 561,500 | — | — | — | — | — | — |
| Exercise of pre-funded warrants | 2,583,242 | 1 | — | — | — | — | 1 |
| Net loss | — | — | — | — | (22,860) | — | (22,860) |
| September 30, 2024 | 45,705,939 | $5 | $256,769 | $— | $(290,825) | 105,144 | $(34,051) |
| 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 |
| Stock-based compensation | — | — | 9,663 | — | — | — | 9,663 |
| Common stock warrants issued with debt | — | — | 2,041 | — | — | — | 2,041 |
| Vesting of restricted stock units | 212,500 | — | — | — | — | — | — |
| Net loss | — | — | — | — | (24,802) | — | (24,802) |
| September 30, 2023 | 42,169,697 | $4 | $248,133 | $— | $(205,834) | 105,144 | $42,303 |
STATEMENTS OF CASH FLOWS
(in thousands)
| For the Nine Months Ended September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Cash flows from operating activities | ||
| Net loss | $(60,377) | $(42,381) |
| Adjustments to reconcile net loss to net cash used in operating activities: | ||
| Stock-based compensation | 6,408 | 12,301 |
| Depreciation expense | 288 | 399 |
| Non-cash interest expense | 1,571 | 338 |
| Loss on disposal of fixed assets | 141 | 61 |
| Amortization of operating lease right-of-use asset | 246 | 220 |
| Amortization of finance lease right-of-use asset | 482 | — |
| Impairment of right-of-use asset | 260 | — |
| Changes in operating assets and liabilities: | ||
| Prepaid expenses and other assets | (1,499) | 1,007 |
| Collaboration revenue receivable, billed and unbilled | 84 | 361 |
| Accounts receivable | 4,401 | (3,946) |
| Accounts payable | (1,499) | 1,623 |
| Accrued expenses and other current liabilities | 4,886 | 6,171 |
| Operating lease liability | (255) | (224) |
| Net cash used in operating activities | (44,863) | (24,070) |
| Cash flows from investing activities | ||
| Purchases of property and equipment | (27) | (135) |
| Net cash used in investing activities | (27) | (135) |
| Cash flows from financing activities | ||
| Proceeds from exercise of stock options | 154 | 7 |
| Repayment of financing lease | (550) | — |
| Payment of debt amendment fees | (1,139) | — |
| Proceeds from issuance of debt, net of issuance costs | — | 44,105 |
| Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | — | 30,301 |
| Payment of equity issuance costs | (163) | (173) |
| Net cash (used in) provided by financing activities | (1,698) | 74,240 |
| Net (decrease) increase in cash and cash equivalents | (46,588) | 50,035 |
| Cash and cash equivalents at the beginning of the period | 69,547 | 34,273 |
| Cash and cash equivalents at the end of the period | $22,959 | $84,308 |
| 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 | $— | $93 |
| Cash paid for interest | $5,492 | $1,319 |
| Right-of-use asset obtained in exchange for lease obligation | $1,976 | $116 |
| Common stock warrants issued with debt | $— | $2,041 |
Notes to Financial Statements
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 September 30, 2024, the Company had an accumulated deficit of $290.8 million. The Company believes its cash, and cash equivalents of $23.0 million as of September 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, pursuant to which the Company borrowed $50.0 million under the Loan Facility (as defined in Note 10) on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. Amounts borrowed under the Loan Facility will mature on July 26, 2028. Payments of the principal amount of borrowings under the Credit Agreement, together with a repayment premium and other fees, are not required under the Credit Agreement unless the Company’s net revenue attributable to YCANTH on a trailing 12-month basis does not equal or exceed specified amounts for specified test periods as set forth in the Credit Agreement (as amended by the Fifth Amendment described below) (the "Revenue Test") beginning on December 31, 2024. If, on a test date, the Company does not achieve the specified amount of revenue on a trailing 12-month basis, then, beginning on the last day of the next full month immediately following the such test date, the Company would be required to repay the outstanding principal amount of the loans on the last day of each month in equal monthly installments through the maturity date, together with the applicable repayment premium and the exit fee. The Company does not anticipate meeting the Revenue Test as of December 31, 2024.
The Credit Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; cross-defaults with certain other indebtedness; bankruptcy and insolvency events; material monetary judgment defaults; impairment of any material definitive loan documentation; other material adverse effects; key permit and other regulatory events; key person events; and change of control. In addition, the Credit Agreement contains a financial covenant that the Company must maintain a liquidity of at least $10.0 million and that the Company’s quarterly and annual financial statements not be subject to any qualification or statement which is of a “going concern” or similar nature. The qualification of a "going concern" was waived for the quarterly financial statements ended September 30, 2024. If the qualification of a "going concern" is not waived for additional future periods or if additional financing is not raised to meet the liquidity test, the Company may be in default of the debt agreement in the near-term. Upon the occurrence of an event of default (subject to notice and grace periods), additional interest of 4% per annum applies and obligations under the Credit Agreement could be accelerated. As of September 30, 2024, the Company was in compliance with all covenants under the Credit Agreement as amended.
Note 2—Significant Accounting Policies
Basis of Presentation
Theaccompanying 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 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 beaffected.
Collateral Cash
Cash and cash equivalents as of September 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
As of September 30, 2024, the Company’s financial instruments included cash equivalents, accounts payable, and notes payable. The carrying amount of cash equivalents 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
The Company hadno accounts receivable as of September 30, 2024. 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 recognized obsolete inventory costs as cost of goods sold in the amount of $0.2 million and $0.6 million for thethree and nine months ended September 30, 2024, respectively, due to expiration of Product and label correction on the Product.
On July 21, 2023, the Company received FDA approval for YCANTH (VP-102) for the treatment of molluscum contagiosumand 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 six months as previously expensed inventory is utilized for commercial production and sold to customers. On a pro forma basis, 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 thethree and nine months ended September 30, 2024 would have been $0.4 million and $1.8 million, respectively.
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 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. The Company has additionally recorded discrete reserves if Product held by distributors, forecasted sales and expiration of Product warrant a reserve. 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. During the three months ended September 30, 2024, the Company increased its returns reserve by $1.7 millionon previously sold Product to its wholesalers as a result of lower than forecasted sell-through and anticipation of expiration of Product prior to complete sell-through.
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 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 for the nine months ended September 30, 2024 in the amount of $0.5 million. 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 nine months ended September 30, 2024, advertising expense was approximately $1.1 million and $3.7 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). Thepre-funded warrants to purchase common stock are included in the calculation ofbasic 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.
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:
| September 30, | ||
|---|---|---|
| 2024 | 2023 | |
| Shares issuable upon exercise of stock options | 6,389,611 | 5,497,015 |
| Non-vested shares under restricted stock grants | 272,500 | 561,500 |
| Shares issuable upon exercise of warrants pursuant to debt financing | 518,551 | 518,551 |
| Shares issuable upon exercise of warrants pursuant to Torii amendment | 500,000 | — |
| Total | 7,680,662 | 6,058,515 |
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):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Raw materials | $1,208 | $420 |
| Work in process | 750 | 487 |
| Finished goods | 626 | 115 |
| Total inventory | $2,584 | $1,022 |
Note 4—Property and Equipment
Property and equipment, net consisted of (in thousands):
| September 30, | December 31, | |
|---|---|---|
| 2024 | 2023 | |
| Machinery and equipment | $1,233 | $1,543 |
| Office equipment | 326 | 326 |
| Office furniture and fixtures | 303 | 303 |
| Leasehold improvements | 54 | 54 |
| 1,916 | 2,226 | |
| Accumulated depreciation | (1,265) | (1,174) |
| Total property and equipment, net | $651 | $1,052 |
Depreciation expense for both the three months ended September 30, 2024 and 2023 was $0.1 million. Depreciation expense for thenine months ended September 30, 2024 and 2023 was $0.3 and $0.4 million, respectively.
Note 5—Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities consisted of the following (in thousands):
| September 30,2024 | December 31,2023 | |
|---|---|---|
| Gross to net reserves | $12,320 | $5,357 |
| Compensation and related costs | 2,663 | 3,438 |
| Professional fees | 2,083 | 1,423 |
| Clinical trials and drug development | 966 | 2,767 |
| Other current liabilities | 428 | 244 |
| Commercial-related costs | 346 | 538 |
| Machinery and equipment | 93 | 93 |
| Total accrued expenses and other current liabilities | $18,899 | $13,860 |
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. On September 3, 2024, the Court granted in part and denied in part Defendants’ motion to dismiss the second amended complaint. The Court dismissed Plaintiff’s claims related to one of the two individual defendants but held that Plaintiff’s claims against the Company and the other individual defendant were sufficiently pled.
In addition, on October 21, 2024, plaintiff Ivan S. Cohen filed a putative stockholder derivative lawsuit in the U.S. District Court for the Eastern District of Pennsylvania. The complaint names the company as a nominal defendant and purports to bring claims on behalf of the company against certain of our current and former directors and officers for alleged violations of the federal securities laws and breaches of their fiduciary duties in relation to substantially the same factual allegations as the above-described putative class action lawsuit. The complaint primarily seeks to recover for the company compensatory damages for losses allegedly sustained related to the facts alleged, restitution, and punitive damages.
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 up front and the remaining $0.4 million is due in December 2024. For thethree and nine months ended September 30, 2024 the Company expensed $0.0 million and $0.8 million in the statement of operations as a settlement of litigation including 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 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.
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 September 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, of which 2,583,333 were exercised resulting in net shares issued of 2,583,242 during the three-month period ended September 30, 2024. The shares of common stock were sold in the underwritten offering 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 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:
| Number of warrants | Exercise Price | Expiration Date | |
|---|---|---|---|
| Pre-funded warrants issued pursuant to 2023 underwritten public offering | 1,481,481 | $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 September 30, | For the Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Selling, general and administrative | $1,503 | $8,438 | $4,841 | $10,223 |
| Research and development | 605 | 1,225 | 1,567 | 2,078 |
| Total stock-based compensation | $2,108 | $9,663 | $6,408 | $12,301 |
Stock Options
The following table summarizes the Company’s stock option activity for thenine months ended September 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 | 1,336,300 | $5.27 | |||
| Exercised | (42,500) | $3.62 | $177,895 | ||
| Forfeited | (365,204) | $6.37 | |||
| Expired | (104,600) | $6.51 | |||
| Outstanding as of September 30, 2024 | 6,389,611 | $7.74 | 6.6 | $16,673 | |
| Options vested and exercisable as of September 30, 2024 | 3,825,889 | $8.96 | 5.1 | $16,673 | |
As of September 30, 2024, the total unrecognized compensation related to unvested stock option awards granted was $11.2 million, which the Company expects to recognize over a weighted-average period of 2.51 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 andhalf of which vested on August 24, 2024.
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 September 30, 2024, the remaining unrecognized compensation expense related to the RSUs was $1.1 million, which the Company expects to recognize over a weighted average service period of 1.9 years.
The following is a summary of changes in the status of non-vested RSUs for thenine months ended September 30, 2024:
| Weighted Average | ||
|---|---|---|
| Grant Date Fair | ||
| Number of Shares | Value | |
| Nonvested as of December 31, 2023 | 561,500 | $9.13 |
| Granted | 272,500 | 4.80 |
| Vested | (561,500) | 9.13 |
| Nonvested as of September 30, 2024 | 272,500 | $4.80 |
Note 9—Leases
The Company leases 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. In September 2024, the Company terminated the agreement effective November 30, 2024. No termination fees were incurred. The right-of-use asset and lease liability was reduced by $12,000 as of September 30, 2024 as a component of selling, general and administrative expense in the statement of operations for the three months ended September 30, 2024.
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. As of September 30, 2024, the Company recognized both a right-of-use asset and a lease liability of $2.0 million related to these finance leases. As a result of the restructuring discussed in Note 12 the Company is terminating the leases on all vehicles held by terminated employees and the lessor is selling the vehicles at auction which is expected to be completed by December 31, 2024. The Company recognized a restructuring charge of $0.3 million related to impairment of the right-of-use asset based on estimated fair value of the vehicles during the three months ended September 30, 2024.
The components of lease expense are as follows (in thousands):
| For the Three Months Ended September 30, | For the Nine Months Ended September 30, | |||
|---|---|---|---|---|
| 2024 | 2023 | 2024 | 2023 | |
| Finance lease cost: | ||||
| Amortization ROU assets | $187 | $1 | $482 | $1 |
| Interest on lease liabilities | 52 | — | 143 | — |
| Total finance lease costs | $239 | $1 | $625 | $1 |
| Operating lease: | ||||
| Operating lease costs | $98 | $93 | $292 | $278 |
| Total operating lease expense | $98 | $93 | $292 | $278 |
Maturities of the Company’s operating and finance leases, excluding short-term leases, as of September 30, 2024 are as follows (in thousands):
| Operating · Finance | ||
|---|---|---|
| 2024 (remaining 3 months) | $96 | $279 |
| 2025 | 360 | 988 |
| 2026 | 366 | 838 |
| 2027 | 247 | 774 |
| Thereafter | — | 329 |
| Total lease payments | 1,069 | 3,208 |
| Less imputed interest | (89) | (380) |
| Lease liability | $980 | $2,828 |
The weighted average remaining lease term and discount rates for the Company's leases as of September 30, 2024 are as follows:
| Operating | Finance | |
|---|---|---|
| Weighted average remaining lease term (years) | 2.90 | 3.71 |
| Weighted average discount rate | 6.25% | 7.75% |
Note 10—Debt
On July 26, 2023 (the “Closing Date”), the Company entered into a Credit Agreement (the “Credit Agreement”), by and between the Company, as borrower, and OrbiMed Royalty & Credit Opportunities IV, LP, a Delaware limited partnership (the “Initial Lender”), as a lender, and each other lender that may from time to time become a party thereto (each, including the Initial Lender, and together with their affiliates, successors, transferees and assignees, the “Lenders”), and OrbiMed Royalty & Credit Opportunities IV, LP, as administrative agent for the Lenders (in such capacity, the “Administrative Agent”). The Credit Agreement provides for a five-year senior secured credit facility in an aggregate principal amount of up to $125.0 million (the “Loan Facility”). The Company borrowed $50.0 million under the Credit Agreement on July 26, 2023, resulting in net proceeds of approximately $44.1 million after payment of certain fees and transaction related expenses. The additional borrowings would potentially be available to the Company subject to achievement of certain revenue targets. Up to $25.0 million could have been 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 (the “Maturity Date”). Payments of the principal amount of borrowings under the Credit Agreement, together with a repayment premium and other fees, are not required under the Credit Agreement unless the Company does not meet the Revenue Test beginning on December 31, 2024. If, on a test date, the Company does not achieve the specified amount of revenue on a trailing 12-month basis, then, beginning on the last day of the next full month immediately following such test date, the Company would be required to repay the outstanding principal amount of the loans on the last day of each month in equal monthly installments through the Maturity Date, together with the applicable repayment premium and the exit fee. The Company does not anticipate meeting the Revenue Test as of December 31, 2024.
During the term of the Loan Facility, interest payable in cash by the Company shall accrue on any outstanding balance due under the Loan Facility at a rate per annum equal to the higher of (x) the Secured Overnight Financing Rate (“SOFR”)rate (which is the forward-looking term rate for a one-month tenor based on the secured overnight financing rate administered by the CME Group Benchmark Administration Limited) and (y)4.00% plus, in either case,8.00%. During an event of default, any outstanding amount under the Loan Facility will bear interest at a rate of 4.00%in excess of the otherwise applicable rate of interest. The Company paid or will pay certain fees with respect to the Loan Facility, including an upfront fee, an unused fee on the undrawn portion of the Loan
Facility, an administration fee, a prepayment premium and an exit fee, as well as certain other fees and expenses of the Administrative Agent and the Lenders.
The Credit Agreement contains customary events of default, including, but not limited to, nonpayment of principal, interest, fees or other amounts; material inaccuracy of a representation or warranty; failure to perform or observe covenants; cross-defaults with certain other indebtedness; bankruptcy and insolvency events; material monetary judgment defaults; impairment of any material definitive loan documentation; other material adverse effects; key permit and other regulatory events; key person events; and change of control. In addition, the Credit Agreement contains a financial covenant that the Company must maintain a liquidity of at least $10.0 million and that the Company’s quarterly and annual financial statements not be subject to any qualification or statement which is of a “going concern” or similar nature. The qualification of a "going concern" was waived for the quarterly financial statements ended September 30, 2024. Upon the occurrence of an event of default (subject to notice and grace periods), additional interest of 4% per annum applies and obligations under the Credit Agreement could be accelerated. As of September 30, 2024, the Company was in compliance with all covenants under the Credit Agreement as amended.
On the Closing Date, the Company also issued the Initial Lender warrants to purchase up to 518,551 shares of the Company’s common stock, at an exercise price of $6.0264 per share, which have a term of 10 years from the issuance date. The warrants were deemed to be classified as equity per the guidance ASC 815 Derivatives and Hedging. The proceeds from the debt transaction were allocated among the two instruments based on their relative fair values. The relative fair value of the warrants was determined to be $2.0 million and the fair value was determined to be $2.4 million based on the Black-Scholes valuation technique and the key assumptions used were as follows: (i) a contracted term of 10 years, (ii) an expected volatility of 94.86%, (iii) a risk free rate of 3.86% and (iv)no estimated dividend yield.
On each of December 20, 2023 and January 31, 2024, the Company entered into amendments (the "First and Second Amendments") to the Credit Agreement in order to extend a deadline for a specified regulatory milestone. For each amendment, the Company paid an amendment fee of $250,000. The Company accounted for the First and Second Amendments as modifications and the amendment fees were reflected in the debt discount and amortized over the life of the Credit Agreement using the effective interest method.
On May 6, 2024, the Company entered into an amendment to the Credit Agreement (the "Third Amendment") pursuant to which the Lenders waived the going concern requirement under Section 7.1(b) of the Credit Agreement with respect to the financial statements for the quarter ended March 31, 2024. In connection with the Third Amendment, the Company paid an amendment fee of $100,000.
On June 26, 2024, the Company entered into an amendment to the Credit Agreement (the "Fourth Amendment") changing the commencement date of the Revenue Test to September 30, 2024. In connection with the Fourth Amendment, the Company paid an amendment fee of $500,000.
On August 2, 2024, the Company entered into thefifth amendment and waiverto the Credit Agreement (the "Fifth Amendment") pursuant to which the Lenders waived the going concern requirement under Section 7.1(b) of the Credit Agreement with respect to the financial statements for the quarters ended June 30, 2024 and September 30, 2024, the commencement date for the Revenue Test was changed to December 31, 2024 and the exit fee for the Initial Loans (as defined in the Credit Agreement) was increased from 5.00% to 7.50%.
The Loan Facility is classified as non-current debt as no event of default has occurred that would result in an acceleration of the repayment of the Loan Facility at September 30, 2024 and the Company does not currently intend to repay amounts borrowed under the Loan Facility, unless it is required to do so, prior to the maturity date of July 26, 2028. The Company has incurred debt discount and issuance costs of $12.8 million, that are netted against the carrying value of the Loan Facility. The debt discount and issuance costs consists of $5.9 million paid in cash during the year ended December 31, 2023, debt amendment costs of $1.1 million paid in cash during the nine month period ended September 30, 2024, the final payment fee of $3.8 million, classified as a long-term liability and the fair value of the warrants of $2.0 million, classified as equity on the balance sheet.
For the three and nine months ended September 30, 2024, the Company recognized interest expense of $2.4 and $7.0 million, respectively, of which $1.8 and $5.4 million, respectively, was interest on the term loan and $0.6 and $1.6 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 of September 30, 2024 (in thousands):
| Gross proceeds from Loan Facility | $50,000 |
|---|---|
| Accrued final payment fee | 3,750 |
| Unamortized debt discount and issuance costs | (10,445) |
| Total long-term debt, net | $43,305 |
Note 11—License and Collaboration Agreements
Torii Agreements
On March 17, 2021, the Company entered into a collaboration and license agreement (the “Torii Agreement”) with Torii, pursuant to which the Company granted Torii an exclusive license to 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 YCANTH (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.
Pursuantto the Torii Agreement, the Company received milestone payments from Torii in prior periods totaling $20.0 million. Additionally, the Company is entitled to receive from Torii an additional $50.0 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-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 (x) ten years after first commercial sale of the first 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 insolvency of, the other party. The Company may terminate the agreement in the event that Torii commences a legal action challenging the validity, enforceability or scope of any licensed patents.
On March 7, 2022, the Company executed a Clinical Supply Agreement with Torii, whereby the Company will supply product to Torii for use in clinical trials and other development activities. The Company recognized collaboration revenue of $0.1 million for each of thethree months ended September 30, 2024 and 2023 and $1.0 and $0.3 million for thenine months ended September 30, 2024 and 2023, respectively, related to supplies and development activity pursuant to this agreement. The costs of collaboration revenue consists of expenses incurred by the Company for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement.
On May 14, 2024, the Company entered into the First Amendment to the Torii Agreement (the “First Amendment”). Pursuant to the First Amendment, the Company and Torii will equally split the cost of a global Phase 3 clinical trial of YCANTH (VP-102) for the treatment of common warts (the “Trial”), with Torii paying all of the costs when due and the Company repaying Torii half of the costs (the “Company Portion”). The results of the global Phase 3 clinical trials will be utilized by the Company in the filing of its new drug application with the FDA for YCANTH (VP-102) for the treatment of common warts. The Company Portion accrues interest annually at the greater of (i) the one-month SOFR plus 2% and (ii)6%. Torii may recoup our share of the costs plus applicable interest against any development milestone payments in the Torii Agreement that would otherwise be due to the Company under the terms of the Torii Agreement. In addition, if Torii has not received payment or other recoupment in full of the Company Portion plus applicable interest within 60 months after the date on which Torii made its first payment for the Trial costs, Torii may invoice the Company for the remaining Company Portion plus applicable interest. No costs were incurred during thenine months ended September 30, 2024 and the global study is expected to commence in first half of 2025.
In conjunction with the First Amendment, the Company issued Torii a warrant to purchase up to 500,000 shares of the Company’s common stock at an exercise price per share of $9.56. The warrant has a term often years and is exercisable only with respect to the shares that have vested as of the date of exercise. The shares underlying the warrant will vest as follows: one-third on the date the first patient is dosed in the Trial, one-third on the date that the database lock with respect to the Trial occurs, and one-third on the date the Company submits a new drug application to the FDA for YCANTH (VP-102) for the treatment of common warts.
Lytix Agreement
In August 2020, the Company entered into an exclusive license agreement with Lytix Biopharma AS (“Lytix”) for the use of licensed technology, referred to as VP-315, 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 has paid Lytix milestone fees of $3.6 million in previous periods. 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 VP-315 anywhere in the world and expiration of regulatory exclusivity for VP-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 andwill 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 VP-315 at the time such sublicense is granted.
Note 12 – Subsequent Event
On October 1, 2024 , the Company terminated 47 employees to reduce costs and optimize the efficiency of its field force (the “Restructuring”). The Company has reduced the number of sales territories from 80 to approximately 33, with a focus on those territories that have historically shown a high prevalence of molluscum. In connection with the Restructuring, the Company expects to incur a one-time charge totaling approximately $0.6 million related to one-time employee termination costs. In addition the Company recognized an impairment charge for right-of-use assets associated with leased vehicles of $0.3 million during the three months ending September 30, 2024 inselling, general and administrative expenses. This restructuring charge will substantially be paid out by December 31, 2024.
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.