Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2024 | Aug. 08, 2024 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2024 | |
Document Fiscal Year Focus | 2024 | |
Document Fiscal Period Focus | Q2 | |
Entity Trading Symbol | VRCA | |
Entity Interactive Data Current | Yes | |
Entity Registrant Name | Verrica Pharmaceuticals Inc. | |
Entity Central Index Key | 0001660334 | |
Entity Current Reporting Status | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 42,668,553 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity File Number | 001-38529 | |
Entity Tax Identification Number | 46-3137900 | |
Title of 12(b) Security | Common Stock, $0.0001 par value | |
Security Exchange Name | NASDAQ | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Incorporation, State or Country Code | DE | |
Entity Address, Address Line One | 44 West Gay Street | |
Entity Address, Address Line Two | Suite 400 | |
Entity Address, City or Town | West Chester | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19380 | |
City Area Code | 484 | |
Local Phone Number | 453-3300 |
BALANCE SHEETS (Unaudited)
BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Current assets: | ||
Cash and cash equivalents | $ 31,930 | $ 69,547 |
Accounts receivable, net | 10,026 | 4,248 |
Unbilled revenue receivable | 182 | 168 |
Inventory | 2,704 | 1,022 |
Prepaid expenses and other 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 |
Current liabilities: | ||
Accounts payable | 1,150 | 2,464 |
Accrued expenses and other current liabilities | 17,850 | 13,860 |
Operating lease liability | 332 | 324 |
Financing lease liability | 719 | 376 |
Total current liabilities | 20,051 | 17,024 |
Operating lease liability | 744 | 910 |
Financing 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 | 0 | 0 |
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 | 0 | 0 |
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 |
BALANCE SHEETS (Unaudited) (Par
BALANCE SHEETS (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2024 | Dec. 31, 2023 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 42,561,197 | 42,518,697 |
Common stock, shares outstanding | 42,456,053 | 42,413,553 |
Treasury Stock, Common, Shares | 105,144 | 105,144 |
STATEMENTS OF OPERATIONS (Unaud
STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Revenues [Abstract] | ||||
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 | 0 | 906 | 0 |
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) | 0 | (4,687) | 0 |
Other expense | (5) | 0 | (16) | 0 |
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 | $ (0.37) | $ (0.24) | $ (0.81) | $ (0.4) |
Net loss per share, diluted | $ (0.37) | $ (0.24) | $ (0.81) | $ (0.4) |
Weighted-average common shares outstanding, basic | 46,502,274 | 45,916,867 | 46,492,971 | 44,478,116 |
Weighted-average common shares outstanding, diluted | 46,502,274 | 45,916,867 | 46,492,971 | 44,478,116 |
Product [Member] | ||||
Revenues [Abstract] | ||||
Total revenue | $ 4,892 | $ 0 | $ 8,124 | $ 0 |
Collaboration [Member] | ||||
Revenues [Abstract] | ||||
Total revenue | $ 285 | $ 182 | $ 879 | $ 219 |
STATEMENTS OF STOCKHOLDERS' (DE
STATEMENTS OF STOCKHOLDERS' (DEFICIT) EQUITY (Unaudited) - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-In Capital [Member] | Subscription Receivable [Member] | Accumulated Deficit [Member] | Treasury Stock, Common [Member] |
Beginning Balance at Dec. 31, 2022 | $ 40,033 | $ 4 | $ 203,482 | $ (163,453) | ||
Beginning Balance (shares) at Dec. 31, 2022 | 41,199,197 | 105,144 | ||||
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 | 30,301 | 30,301 | ||||
Issuance of common stock and pre-funded warrants, for the purchase of common stock, net of issuance costs, Shares | 750,000 | |||||
Exercise of stock options | 7 | 7 | ||||
Exercise of stock options (shares) | 8,000 | |||||
Net Income (Loss) | (6,589) | (6,589) | ||||
Ending Balance at Mar. 31, 2023 | 64,846 | $ 4 | 234,884 | (170,042) | ||
Ending Balance (shares) at Mar. 31, 2023 | 41,957,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2022 | 40,033 | $ 4 | 203,482 | (163,453) | ||
Beginning Balance (shares) at Dec. 31, 2022 | 41,199,197 | 105,144 | ||||
Net Income (Loss) | (17,579) | |||||
Ending Balance at Jun. 30, 2023 | 55,400 | $ 4 | 236,428 | (181,032) | ||
Ending Balance (shares) at Jun. 30, 2023 | 41,957,197 | 105,144 | ||||
Beginning Balance at Mar. 31, 2023 | 64,846 | $ 4 | 234,884 | (170,042) | ||
Beginning Balance (shares) at Mar. 31, 2023 | 41,957,197 | 105,144 | ||||
Stock-based compensation | 1,544 | 1,544 | ||||
Net Income (Loss) | (10,990) | (10,990) | ||||
Ending Balance at Jun. 30, 2023 | 55,400 | $ 4 | 236,428 | (181,032) | ||
Ending Balance (shares) at Jun. 30, 2023 | 41,957,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2023 | 19,763 | $ 4 | 250,207 | (230,448) | ||
Beginning Balance (shares) at Dec. 31, 2023 | 42,518,697 | 105,144 | ||||
Stock-based compensation | 2,072 | 2,072 | ||||
Exercise of stock options | 4 | 8 | $ (4) | |||
Exercise of stock options (shares) | 6,500 | |||||
Net Income (Loss) | (20,331) | (20,331) | ||||
Ending Balance at Mar. 31, 2024 | 1,508 | $ 4 | 252,287 | (4) | (250,779) | |
Ending Balance (shares) at Mar. 31, 2024 | 42,525,197 | 105,144 | ||||
Beginning Balance at Dec. 31, 2023 | $ 19,763 | $ 4 | 250,207 | (230,448) | ||
Beginning Balance (shares) at Dec. 31, 2023 | 42,518,697 | 105,144 | ||||
Exercise of stock options (shares) | 42,500 | |||||
Net Income (Loss) | $ (37,517) | |||||
Ending Balance at Jun. 30, 2024 | (13,300) | $ 4 | 254,661 | (267,965) | ||
Ending Balance (shares) at Jun. 30, 2024 | 42,561,197 | 105,144 | ||||
Beginning Balance at Mar. 31, 2024 | 1,508 | $ 4 | 252,287 | (4) | (250,779) | |
Beginning Balance (shares) at Mar. 31, 2024 | 42,525,197 | 105,144 | ||||
Stock-based compensation | 2,228 | 2,228 | ||||
Exercise of stock options | 150 | 146 | $ 4 | |||
Exercise of stock options (shares) | 36,000 | |||||
Net Income (Loss) | (17,186) | (17,186) | ||||
Ending Balance at Jun. 30, 2024 | $ (13,300) | $ 4 | $ 254,661 | $ (267,965) | ||
Ending Balance (shares) at Jun. 30, 2024 | 42,561,197 | 105,144 |
STATEMENTS OF CASH FLOWS (Unaud
STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 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 | 0 |
Loss on disposal of fixed assets | 141 | 0 |
Amortization of operating lease right-of-use asset | 153 | 143 |
Amortization of finance lease right-of-use asset | 294 | 0 |
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) | 0 |
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) | 0 |
Repayment of financing lease | (333) | 0 |
Proceeds from issuance of common stock and pre-funded warrants, net of issuance costs | 0 | 30,301 |
Payment of equity issuance costs | 0 | (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 | 0 |
Cash paid for interest | 3,688 | 0 |
Right-of-use asset obtained in exchange for lease obligation | $ 1,413 | $ 0 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Pay vs Performance Disclosure | ||||||
Net Income (Loss) | $ (17,186) | $ (20,331) | $ (10,990) | $ (6,589) | $ (37,517) | $ (17,579) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Jun. 30, 2024 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Rule 10b51 Arr Modified Flag | false |
Non Rule 10b51 Arr Modified Flag | false |
Organization and Description of
Organization and Description of Business Operations | 6 Months Ended |
Jun. 30, 2024 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and Description of Business Operations | 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 . |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies | 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 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 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. 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 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Inventory | N ote 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 |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 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. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Note 5—Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 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 |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2024 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 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 . |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2024 | |
Equity [Abstract] | |
Stockholders' Equity | 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 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 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 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 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: 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 |
Leases
Leases | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Leases | N ote 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): Operating Finance 2024 (remaining 6 months) $ 196 $ 468 2025 372 812 2026 366 688 2027 247 643 Thereafter — 217 Total lease payments 1,181 2,828 Less imputed interest ( 105 ) ( 345 ) Lease liability $ 1,076 $ 2,483 The weighted average remaining lease term and discount rates for the Company's leases as of June 30, 2024 are as follows: Operating Finance Weighted average remaining lease term (years) 3.11 3.86 Weighted average discount rate 6.25 % 7.76 % |
Debt
Debt | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Debt | 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”). P ayments 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. 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. 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 June 30, 2024, the Company is 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 the fifth amendment and waiver to 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 June 30, 2024 and the Company does not currently intend to repay amounts borrowed under the Loan Facility prior to the maturity date of July 26, 2028. The Company has incurred debt discount and issuance costs of $ 10.4 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 and the final payment fee of $ 2.5 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 six months ended June 30, 2024, the Company recognized interest expense of $ 2.3 and $ 4.6 million, respectively, of which $ 1.8 and $ 3.6 million, respectively, was i nterest on the term loan and $ 0.5 and $ 1.0 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 June 30, 2024 (in thousands): Gross proceeds from Loan Facility $ 50,000 Accrued final payment fee 2,500 Unamortized debt discount and issuance costs ( 9,749 ) Total long-term debt, net $ 42,751 |
License And Collaboration Agree
License And Collaboration Agreements | 6 Months Ended |
Jun. 30, 2024 | |
License And Collaboration Agreements [Abstract] | |
License and Collaboration Agreements | 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. Pursuant to 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 $ 0.3 and $ 0.2 million for the three months ended June 30, 2024 and 2023 , respectively, and $ 0.9 and $ 0.2 million for the six months ended June 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 %. The Company is able to offset the Company Portion owed to Torii plus applicable interest against certain of the milestone-based payments 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 the six month period ended June 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 of ten 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 and will be subject to the royalty payment obligations under the Lytix Agreement, and all royalties received by the Company from a sublicensee shall be shared with Lytix at a rate that is initially 50 % but decreases based on the stage of development of VP-315 at the time such sublicense is granted. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2024 | |
Subsequent Events [Abstract] | |
Subsequent Event | Note 12 – Subsequent Event As disclosed in Note 10 above, on August 2, 2024, the Company entered into 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 %. |
Significant Accounting Polici_2
Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Basis of Presentation | 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 | 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 be affected. |
Collateral Cash | 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 | 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 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 | 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 | 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 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 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 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 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. 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 |
Significant Accounting Polici_3
Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Accounting Policies [Abstract] | |
Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share | 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 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Inventory Disclosure [Abstract] | |
Schedule Of Inventory | 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 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property and Equipment, Net | 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 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): June 30, December 31, 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 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Company's Outstanding 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 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Schedule of Stock Based Compensation Expense | 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 |
Summary of Stock Option Activity | 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 3,650,897 $ 8.99 5.6 $ 1,849,369 |
Schedule of Restricted Stock Awards Activities | The following is a summary of changes in the status of non-vested RSUs for the six months ended June 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 Nonvested as of June 30, 2024 834,000 $ 7.72 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Leases [Abstract] | |
Summary of Components of Lease Expense | 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 |
Schedule of Maturities of Operating and Finance Leases | Maturities of the Company’s operating and finance leases, excluding short-term leases, as of June 30, 2024 are as follows (in thousands): Operating Finance 2024 (remaining 6 months) $ 196 $ 468 2025 372 812 2026 366 688 2027 247 643 Thereafter — 217 Total lease payments 1,181 2,828 Less imputed interest ( 105 ) ( 345 ) Lease liability $ 1,076 $ 2,483 |
Schedule of Weighted Average Remaining Term and Discount Rate | The weighted average remaining lease term and discount rates for the Company's leases as of June 30, 2024 are as follows: Operating Finance Weighted average remaining lease term (years) 3.11 3.86 Weighted average discount rate 6.25 % 7.76 % |
Debt (Tables)
Debt (Tables) | 6 Months Ended |
Jun. 30, 2024 | |
Debt Disclosure [Abstract] | |
Summary of Composition of Debt | The following table summarizes the composition of debt as of June 30, 2024 (in thousands): Gross proceeds from Loan Facility $ 50,000 Accrued final payment fee 2,500 Unamortized debt discount and issuance costs ( 9,749 ) Total long-term debt, net $ 42,751 |
Organization and Description _2
Organization and Description of Business Operations - Additional Information (Detail) - USD ($) $ in Thousands | Jul. 26, 2024 | Jul. 26, 2023 | Jun. 30, 2024 | Dec. 31, 2023 |
Description Of Business [Line Items] | ||||
Accumulated deficit | $ (267,965) | $ (230,448) | ||
Line of Credit Unavailable For Borrowing | $ 25,000 | |||
Cash and cash equivalents | $ 31,930 | $ 69,547 | ||
Term A Loan [Member] | ||||
Description Of Business [Line Items] | ||||
Proceeds from issuance of common stock, net of issuance costs | 44,100 | |||
Maximum borrowing capacity | 125,000 | |||
Line of credit | 50,000 | |||
Loans, maturity date | Jul. 26, 2028 | |||
Available On Or Prior To June 30, 2024 [Member] | ||||
Description Of Business [Line Items] | ||||
Line of Credit Facility, Remaining Borrowing Capacity | 25,000 | |||
Available On Or Prior To December 31, 2024 [Member] | ||||
Description Of Business [Line Items] | ||||
Line of Credit Facility, Remaining Borrowing Capacity | 30,000 | |||
Available On Or Prior To March 31, 2025 [Member] | ||||
Description Of Business [Line Items] | ||||
Line of Credit Facility, Remaining Borrowing Capacity | 10,000 | |||
Available On Or Prior To June 30, 2025 [Member] | ||||
Description Of Business [Line Items] | ||||
Line of Credit Facility, Remaining Borrowing Capacity | $ 10,000 |
Significant Accounting Polici_4
Significant Accounting Policies - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jul. 21, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2023 | |
Significant Accounting Policies [Line Items] | ||||||
Banking cash deposits | $ 500 | $ 500 | ||||
Accounts receivable | 10,026 | 10,026 | $ 4,248 | |||
Allowance for doubtful accounts | 0 | 0 | ||||
Finished goods | 872 | $ 872 | $ 115 | |||
Basic exercise price | $ 0.0001 | |||||
Diluted exercise price | $ 0.0001 | |||||
Research and development expense | $ 4,500 | 3,319 | $ 5,725 | $ 8,267 | $ 8,464 | |
Cost of product revenue | 700 | 1,400 | ||||
Advertising expense | 1,100 | 2,600 | ||||
FDA | ||||||
Significant Accounting Policies [Line Items] | ||||||
Research and development expense | 400 | 500 | ||||
YCANTH [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Finished goods | 14,000 | |||||
Research and development expense | $ 1,200 | |||||
Obsolete inventory costs [Member] | ||||||
Significant Accounting Policies [Line Items] | ||||||
Research and development expense | 200 | 200 | ||||
Cost of product revenue | $ 200 | $ 200 |
Significant Accounting Polici_5
Significant Accounting Policies - Schedule of Potential Shares Outstanding not Included in Computation of Diluted Net Loss Per Common Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2024 | Jun. 30, 2023 | |
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 8,509,072 | 6,223,315 |
Shares issuable upon exercise of stock options [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 6,656,521 | 5,100,315 |
Non-vested shares under restricted stock grants [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 834,000 | 1,123,000 |
Warrant [Member] | Debt Financing [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 518,551 | 0 |
Warrant [Member] | Torii Amendment [Member] | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Securities that could potentially dilute basic earnings per share | 500,000 | 0 |
Inventory - Schedule Of Invento
Inventory - Schedule Of Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,149 | $ 420 |
Work in process | 683 | 487 |
Finished goods | 872 | 115 |
Total inventory | $ 2,704 | $ 1,022 |
Property and Equipment - Schedu
Property and Equipment - Schedule of Property and Equipment, Net (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 1,914 | $ 2,226 |
Accumulated depreciation | (1,204) | (1,174) |
Total property and equipment, net | 710 | 1,052 |
Machinery and Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 1,231 | 1,543 |
Office Equipment [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 326 | 326 |
Office Furniture and Fixtures [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 303 | 303 |
Leasehold Improvements [Member] | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 54 | $ 54 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Property, Plant and Equipment [Abstract] | ||||
Depreciation expense | $ 100 | $ 100 | $ 227 | $ 266 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jul. 21, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Related Party Transaction [Line Items] | |||||
Selling, general and administrative | $ 16,522 | $ 5,937 | $ 32,861 | $ 10,256 | |
Research and development | $ 4,500 | $ 3,319 | $ 5,725 | $ 8,267 | $ 8,464 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2024 | Dec. 31, 2023 |
Accrued Liabilities, Current [Abstract] | ||
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 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2023 | Dec. 31, 2022 | |
Product Liability Contingency [Line Items] | ||||
Proceeds from settlement of litigation | $ 0.8 | |||
Litigation Expenses Paid Upfront | 0.4 | |||
Litigation Settlement, Fee Expense | $ 0.8 | 0.8 | ||
Loss Contingency, Accrual, Current | $ 0.4 | 0.4 | ||
Prepaid expense | $ 0.7 | |||
Accrued Expenses and Other Current Liabilities | ||||
Product Liability Contingency [Line Items] | ||||
Litigation Expenses Paid Upfront | $ 0.4 | |||
Crude Cantharidin Material [Member] | ||||
Product Liability Contingency [Line Items] | ||||
Purchase agreement term | 5 years | |||
Purchase commitment | $ 0.7 | |||
Purchase commitment prepayment | $ 0.7 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | ||
Feb. 28, 2023 | Jun. 30, 2024 | Dec. 31, 2023 | |
Class of Stock [Line Items] | |||
Common stock, shares authorized | 200,000,000 | 200,000,000 | |
Common stock, par value | $ 0.0001 | $ 0.0001 | |
Pre Funded Warrant [Member] | |||
Class of Stock [Line Items] | |||
Pre-funded warrants to purchase shares of common stock | 4,064,814 | ||
Warrant price (per share) | $ 6.7499 | $ 0.0001 | |
Underwritten Offering [Member] | |||
Class of Stock [Line Items] | |||
Number of common shares sold | 750,000 | ||
Shares Issued, Price Per Share | $ 6.75 | ||
Sale of stock consideration | $ 30.3 | ||
Underwritten Offering [Member] | Pre Funded Warrant [Member] | |||
Class of Stock [Line Items] | |||
Pre-funded warrants to purchase shares of common stock | 4,064,814 |
Stockholders' Equity - Summary
Stockholders' Equity - Summary of Company's Outstanding Warrants (Detail) - $ / shares | Jun. 30, 2024 | Feb. 28, 2023 |
Pre-funded warrants issued pursuant to 2023 underwritten public offering [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of warrants | 4,064,814 | |
Exercise Price | $ 0.0001 | $ 6.7499 |
Warrants issued in connection with OrbiMed debt facility [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of warrants | 518,551 | |
Exercise Price | $ 6.0264 | |
Expiration Date | Jul. 25, 2033 | |
Warrants issued in connection with Torii amendment [Member] | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Number of warrants | 500,000 | |
Exercise Price | $ 9.56 | |
Expiration Date | May 14, 2034 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Stock Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 2,228 | $ 1,544 | $ 4,300 | $ 2,638 |
Selling, General and Administrative Expenses [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | 1,715 | 950 | 3,337 | 1,785 |
Research and Development [Member] | ||||
Share-Based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation | $ 513 | $ 594 | $ 963 | $ 853 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2024 USD ($) $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement, Additional Disclosure [Abstract] | ||
Number of shares, Outstanding Beginning Balance | shares | 5,565,615 | |
Number of shares, Granted | shares | 1,228,700 | |
Number of shares, Exercised | shares | (42,500) | |
Number of shares, Forfeited | shares | (95,294) | |
Number of shares, Outstanding Ending Balance | shares | 6,656,521 | 5,565,615 |
Number of shares, Options vested and exercisable Ending Balance | shares | 3,650,897 | |
Weighted average exercise price, Outstanding Beginning Balance | $ / shares | $ 8.25 | |
Weighted average exercise price, Granted | $ / shares | 5.4 | |
Weighted average exercise price, Exercised | $ / shares | 3.62 | |
Weighted average exercise price, Forfeited | $ / shares | 6.12 | |
Weighted average exercise price, Outstanding Ending Balance | $ / shares | 7.74 | $ 8.25 |
Weighted average exercise price, Options vested and exercisable Ending Balance | $ / shares | $ 8.99 | |
Weighted average remaining contractual life (in years), Outstanding | 7 years 1 month 6 days | 7 years 2 months 12 days |
Weighted average remaining contractual life (in years), Options vested and exercisable | 5 years 7 months 6 days | |
Aggregate intrinsic value, Outstanding | $ | $ 6,260,166 | $ 4,143,150 |
Aggregate intrinsic value, Exercised | $ | 207,665 | |
Aggregate intrinsic value, Options vested and exercisable Ending Balance | $ | $ 1,849,369 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||||
Aug. 24, 2024 | Jul. 21, 2024 | Aug. 24, 2023 | Jul. 21, 2023 | Aug. 31, 2020 | Nov. 30, 2019 | Jun. 30, 2024 | Mar. 31, 2024 | Jun. 30, 2023 | Mar. 31, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Total unrecognized compensation | $ 13,700 | $ 13,700 | ||||||||||
Weighted-average stock option recognize period | 2 years 9 months 7 days | |||||||||||
Stock-based compensation | 2,228 | $ 1,544 | $ 4,300 | $ 2,638 | ||||||||
Nonvested, Number of Shares, Forfeited | 125,000 | |||||||||||
Restricted Stock Units (RSUs) [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Percentage of stock subject to vesting (as a percent) | 25% | |||||||||||
Weighted-average stock option recognize period | 1 year 7 months 6 days | |||||||||||
Number of Shares, Granted | 272,500 | |||||||||||
Remaining unrecognized compensation related to nonvested restricted stock units | $ 1,600 | $ 1,600 | ||||||||||
Restricted Stock Units (RSUs) [Member] | Executive Officers [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Number of Shares, Granted | 250,000 | 300,000 | 272,500 | 698,000 | ||||||||
Restricted Stock Units (RSUs) [Member] | New Drug Application [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Percentage of stock subject to vesting (as a percent) | 50% | 50% | ||||||||||
Restricted Stock Units (RSUs) [Member] | Forecast [Member] | YCANTH [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Percentage of stock subject to vesting (as a percent) | 50% | |||||||||||
Restricted Stock Units (RSUs) [Member] | Forecast [Member] | One Year Anniversary [Member] | ||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||||||||||||
Percentage of stock subject to vesting (as a percent) | 50% |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Non-vested RSUs Activities (Detail) - Restricted Stock Units (RSUs) [Member] | 6 Months Ended |
Jun. 30, 2024 $ / shares shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |
Nonvested, Number of Shares, Beginning Balance | shares | 561,500 |
Nonvested, Number of Shares, Granted | shares | 272,500 |
Nonvested, Number of Shares, Ending Balance | shares | 834,000 |
Nonvested, Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 9.13 |
Nonvested, Weighted Average Grant Date Fair Value, Granted | $ / shares | 4.8 |
Nonvested, Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 7.72 |
Leases - Additional Information
Leases - Additional Information (Detail) | 6 Months Ended | |
Jun. 30, 2024 USD ($) ft² | Dec. 31, 2023 USD ($) | |
Lessee Lease Description [Line Items] | ||
Lease expiration date | Sep. 01, 2027 | |
Finance lease right-of-use asset | $ 2,524,000 | $ 1,405,000 |
Pennsylvania [Member] | ||
Lessee Lease Description [Line Items] | ||
Area of office space for lease | ft² | 11,201 | |
NEW JERSEY | ||
Lessee Lease Description [Line Items] | ||
Lease agreement commencement date | May 01, 2022 | |
Lease expiration date | Apr. 30, 2025 | |
Operating lease, base rent | $ 104,000 | |
Automobile Fleet Lease Program [Member] | ||
Lessee Lease Description [Line Items] | ||
Term of lease | 52 months | |
Finance lease right-of-use asset | $ 1,400,000 | |
Landlord's Operating Expense [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, base rent | $ 2,400,000 |
Leases - Summary of Components
Leases - Summary of Components of Lease Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | |
Leases [Abstract] | ||||
Amortization ROU assets | $ 156 | $ 0 | $ 294 | $ 0 |
Interest on lease liabilities | 46 | 0 | 90 | 0 |
Total finance lease costs | 202 | 0 | 384 | 0 |
Operating lease costs | 97 | 35 | 194 | 71 |
Total operating lease expense | $ 97 | $ 35 | $ 194 | $ 71 |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Operating and Finance Leases (Detail) $ in Thousands | Jun. 30, 2024 USD ($) |
Leases [Abstract] | |
Operating Lease, Remainder of Fiscal Year | $ 196 |
Operating Lease, Year One | 372 |
Operating Lease, Year Two | 366 |
Operating Lease, Year Three | 247 |
Operating Lease, After Year Three | 0 |
Operating Lease, Total lease payments | 1,181 |
Less Operating Lease, imputed interest | (105) |
Operating Lease, Lease liability | 1,076 |
Finance Lease, Remainder of Fiscal Year | 468 |
Finance Lease, Year One | 812 |
Finance Lease, Year Two | 688 |
Finance Lease, Year Three | 643 |
Finance Lease, After Year Three | 217 |
Finance Lease, Total lease payments | 2,828 |
Less Finance Lease, imputed interest | (345) |
Finance Lease, Lease liability | $ 2,483 |
Leases - Schedule of Weighted A
Leases - Schedule of Weighted Average Remaining Term and Discount Rate (Detail) | Jun. 30, 2024 |
Leases [Abstract] | |
Operating lease, Weighted average remaining lease term | 3 years 1 month 9 days |
Operating lease, Weighted-average discount rate | 6.25% |
Finance lease, Weighted average remaining lease term | 3 years 10 months 9 days |
Finance lease, Weighted-average discount rate | 7.76% |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | |||||||
Jul. 26, 2024 | Jun. 26, 2024 | May 06, 2024 | Jan. 31, 2024 | Jul. 26, 2023 | Jun. 30, 2024 | Jun. 30, 2024 | Dec. 31, 2024 | Dec. 31, 2023 | |
Debt Instrument [Line Items] | |||||||||
Amount unavailable for borrowing | $ 25,000 | ||||||||
Fair value of the warrants | $ 2,400 | ||||||||
Upfront amendment fee | $ 500,000 | $ 100,000 | $ 250,000 | ||||||
Minimum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of change in exit fee for the initial loans | 5% | ||||||||
Common Stock [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Warrant issued to purchase company's common stock | 518,551 | ||||||||
Warrant price (per share) | $ 6.0264 | ||||||||
Warrant term | 10 years | ||||||||
Warrant [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Fair value of the warrants | $ 2,000 | ||||||||
Expected term (years) | 10 years | ||||||||
Expected volatility | 94.86% | ||||||||
Risk free rate | 3.86% | ||||||||
Expected dividend yield | 0% | ||||||||
Forecast [Member] | Minimum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of change in exit fee for the initial loans | 5% | ||||||||
Forecast [Member] | Maximum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Percentage of change in exit fee for the initial loans | 7.50% | ||||||||
Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | $ 125,000 | ||||||||
Initial Commitment Amount | 50,000 | ||||||||
Net proceeds after payment of certain fees and transaction related expenses | $ 44,100 | ||||||||
Loans, maturity date | Jul. 26, 2028 | ||||||||
SOFR [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Interest rate (as a percent) | 4% | ||||||||
Loans, interest rate | 8% | ||||||||
Interest rate (as a percent) | 4% | ||||||||
Available On Or Prior To June 30, 2024 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | $ 25,000 | ||||||||
Available On Or Prior To June 30, 2024 [Member] | Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 25,000 | ||||||||
Available On Or Prior To December 31, 2024 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 30,000 | ||||||||
Available On Or Prior To December 31, 2024 [Member] | Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 30,000 | ||||||||
Available On Or Prior To March 31, 2025 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 10,000 | ||||||||
Available On Or Prior To March 31, 2025 [Member] | Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 10,000 | ||||||||
Available On Or Prior To June 30, 2025 [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 10,000 | ||||||||
Available On Or Prior To June 30, 2025 [Member] | Loan Facility [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | 10,000 | ||||||||
Term A Loan [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Maximum borrowing capacity | 125,000 | ||||||||
Loans, maturity date | Jul. 26, 2028 | ||||||||
Line of credit | 50,000 | ||||||||
Senior Loan Agreement [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Debt discount and issuance costs | 10,400 | $ 5,900 | |||||||
Final payment fee | 2,000 | ||||||||
Interest expense | $ 2,300 | $ 4,600 | |||||||
Interest on term loan | 1,800 | 3,600 | |||||||
Non-cash interest expense | $ 500 | $ 1,000 | |||||||
Senior Loan Agreement [Member] | Contra-Liability [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Final payment fee | $ 2,500 | ||||||||
Credit Agreement [Member] | Minimum [Member] | |||||||||
Debt Instrument [Line Items] | |||||||||
Remaining commitment amount | $ 10,000 |
Debt - Summary of Composition o
Debt - Summary of Composition of Debt (Detail) - Senior Loan Agreement [Member] $ in Thousands | Jun. 30, 2024 USD ($) |
Debt Instrument [Line Items] | |
Gross proceeds from Loan Facility | $ 50,000 |
Accrued final payment fee | 2,500 |
Unamortized debt discount and issuance costs | (9,749) |
Total short-term debt, net | $ 42,751 |
License and Collaboration Agr_2
License and Collaboration Agreements - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||||
May 14, 2024 | Mar. 17, 2021 | Aug. 31, 2020 | Jun. 30, 2024 | Jun. 30, 2023 | Jun. 30, 2024 | Jun. 30, 2023 | Dec. 31, 2020 | |
Ltyix [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Payments upon achievements of milestone | $ 111,000 | |||||||
One time up front license fee | $ 3,600 | |||||||
Percentage of royalty income shared | 50% | |||||||
Torii Agreement [Member] | Torii [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Received payment | $ 20,000 | |||||||
Payments upon achievements of milestone | $ 50,000 | 50,000 | ||||||
Billed collaboration revenue | $ 300 | $ 200 | 900 | $ 200 | ||||
Torii Agreement [Member] | Torii [Member] | Minimum [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Mid Percentage of transfer price payments for supply of product net sales | 30% | |||||||
Torii Agreement [Member] | Torii [Member] | Maximum [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Mid Percentage of transfer price payments for supply of product net sales | 40% | |||||||
First Amendment [Member] | Torii [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Received payment | $ 0 | |||||||
Debt Instrument, Basis Spread on Variable Rate | 6% | |||||||
Number of warrants | 500,000 | |||||||
Exercise Price | $ 9.56 | |||||||
Warrant term | 10 years | |||||||
First Amendment [Member] | Torii [Member] | SOFR [Member] | ||||||||
License And Collaboration Agreements [Line Items] | ||||||||
Debt Instrument, Basis Spread on Variable Rate | 2% |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Details) | Dec. 31, 2024 |
Minimum [Member] | |
Subsequent Event [Line Items] | |
Percentage of change in exit fee for the initial loans | 5% |
Forecast [Member] | Minimum [Member] | |
Subsequent Event [Line Items] | |
Percentage of change in exit fee for the initial loans | 5% |
Forecast [Member] | Maximum [Member] | |
Subsequent Event [Line Items] | |
Percentage of change in exit fee for the initial loans | 7.50% |