Verrica Pharmaceuticals(VRCA)

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Verrica Pharmaceuticals(VRCA) - 2021 Q2 - Quarterly Report
2021-08-10 12:04
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) OR Verrica Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 46-3137900 (State or other jurisdiction of incorporation or organization) 44 West Gay Street, Suite 400 West Chester, PA 19380 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (484) 453-3300 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 ...
Verrica Pharmaceuticals(VRCA) - 2021 Q1 - Quarterly Report
2021-05-07 12:01
[PART I. FINANCIAL INFORMATION](index=3&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) For the quarter ended March 31, 2021, the company reported a significant increase in total assets to $108.1 million, driven by a follow-on public offering and a new license agreement. The company recognized $12.0 million in license revenue, resulting in a substantially reduced net loss of $0.9 million compared to $9.8 million in the prior-year period. Cash flows were primarily influenced by financing activities, including $28.1 million net proceeds from a stock issuance and $5.0 million from debt [Condensed Balance Sheets](index=3&type=section&id=Condensed%20Balance%20Sheets) As of March 31, 2021, total assets increased to $108.1 million from $74.2 million at year-end 2020, primarily due to a rise in cash and cash equivalents and a new license receivable. Total liabilities grew to $46.3 million, mainly from an increase in debt, while stockholders' equity more than doubled to $61.8 million following a recent stock offering Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $44,101 | $10,686 | | License receivable | $11,500 | $0 | | **Total Assets** | **$108,102** | **$74,154** | | Current debt, net | $40,669 | $35,315 | | **Total Liabilities** | **$46,292** | **$41,168** | | **Total Stockholders' Equity** | **$61,810** | **$32,986** | [Condensed Statements of Operations and Comprehensive Loss](index=4&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2021, the company generated $12.0 million in license revenue, a new revenue stream compared to the same period in 2020. This revenue offset operating expenses, leading to a minimal net loss of $0.9 million, or ($0.04) per share, a significant improvement from the $9.8 million net loss, or ($0.39) per share, in Q1 2020 Q1 2021 vs Q1 2020 Statement of Operations (in thousands, except per share data) | Metric | Q1 2021 | Q1 2020 | | :--- | :--- | :--- | | License revenue | $12,000 | $0 | | Research and development | $5,362 | $4,892 | | General and administrative | $6,578 | $4,988 | | Income (loss) from operations | $60 | ($9,880) | | **Net loss** | **($936)** | **($9,822)** | | **Net loss per share** | **($0.04)** | **($0.39)** | [Condensed Statements of Cash Flows](index=6&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) In Q1 2021, net cash used in operating activities was $10.8 million, influenced by a new $11.5 million license receivable. Investing activities provided $10.8 million from net sales of marketable securities. Financing activities were the primary source of cash, providing $33.4 million from a common stock issuance ($28.1 million net) and new debt proceeds ($5.0 million), resulting in a net cash increase of $33.4 million Cash Flow Summary for the Three Months Ended March 31 (in thousands) | Cash Flow Category | 2021 | 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | ($10,785) | ($7,906) | | Net cash provided by investing activities | $10,835 | $18,274 | | Net cash provided by financing activities | $33,365 | $34,877 | | **Net increase in cash and cash equivalents** | **$33,415** | **$45,245** | [Notes to Condensed Financial Statements](index=7&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) Key notes highlight significant events in Q1 2021, including a collaboration and license agreement with Torii that generated $12.0 million in revenue, a follow-on public offering raising $28.1 million, and an additional $5.0 million borrowed under a mezzanine loan agreement. The company also disclosed a probable future non-compliance with a minimum liquidity debt covenant, leading to the classification of all outstanding debt as a current liability - The company entered into a collaboration and license agreement with Torii Pharmaceutical Co., Ltd. in March 2021, granting Torii exclusive rights to develop and commercialize cantharidin-based product candidates in Japan. This resulted in an **$11.5 million upfront payment** received in April 2021 and recognized as revenue in Q1[80](index=80&type=chunk)[81](index=81&type=chunk) - The company borrowed an additional **$5.0 million** on March 1, 2021, under its Mezzanine Loan Agreement. Due to a probable future breach of the minimum liquidity covenant, the entire outstanding debt principal and fees have been classified as a **current liability**[54](index=54&type=chunk)[64](index=64&type=chunk) - In March 2021, the company completed a follow-on public offering, selling 2,033,899 shares of common stock which resulted in net proceeds of **$28.1 million**[19](index=19&type=chunk)[97](index=97&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's focus on developing its lead product candidate, VP-102, for molluscum and warts, highlighting the resubmission of its NDA with a PDUFA date of June 23, 2021. The analysis of Q1 2021 results emphasizes the $12.0 million license revenue from the Torii agreement, which significantly reduced the net loss. The company believes its existing cash, combined with the Torii upfront payment, is sufficient to fund operations through the second quarter of 2023, despite acknowledging the probability of not meeting a debt covenant within the next year [Overview](index=18&type=section&id=Overview) Verrica is a dermatology therapeutics company focused on commercializing its lead product candidate, VP-102, for molluscum contagiosum and common warts. The company resubmitted its NDA for VP-102 for molluscum in December 2020, with an FDA PDUFA goal date of June 23, 2021. A recent collaboration with Torii Pharmaceutical for the Japanese market and a follow-on public offering have strengthened the company's financial position - The company's lead product candidate is **VP-102**, a drug-device combination for treating molluscum and common warts, conditions with no current FDA-approved treatments[89](index=89&type=chunk) - The NDA for VP-102 for the treatment of molluscum was resubmitted in December 2020, and the FDA has set a **PDUFA goal date of June 23, 2021**[90](index=90&type=chunk) - The company entered into a collaboration and license agreement with Torii Pharmaceutical for VP-102 in Japan, receiving an **$11.5 million upfront payment** in April 2021[93](index=93&type=chunk) [Results of Operations](index=22&type=section&id=Results%20of%20Operations) For Q1 2021, the company reported $12.0 million in license revenue from the Torii agreement, compared to none in Q1 2020. Research and development expenses increased by $0.5 million to $5.4 million, primarily due to a $2.3 million milestone payment to Lytix. General and administrative expenses rose by $1.6 million to $6.6 million due to increased headcount and pre-commercial activities for VP-102 Comparison of Results for the Three Months Ended March 31 (in thousands) | Item | 2021 | 2020 | Change | Reason for Change | | :--- | :--- | :--- | :--- | :--- | | License revenue | $12,000 | $0 | $12,000 | Revenue recognized from the Torii Agreement | | Research and development | $5,362 | $4,892 | $470 | Increased due to a $2.3M milestone payment to Lytix | | General and administrative | $6,578 | $4,988 | $1,590 | Increased headcount and pre-commercial activities | | **Net loss** | **($936)** | **($9,822)** | **$8,886** | Driven by new license revenue | [Liquidity and Capital Resources](index=23&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company had $87.7 million in cash, cash equivalents, and marketable securities. Liquidity was bolstered by a March 2021 public offering that raised $28.1 million net, and an additional $5.0 million drawn from its loan facility. The company believes its current funds, plus the $11.5 million upfront payment from Torii received in April 2021, are sufficient to fund operations at least through Q2 2023. However, it is probable the company will not be in compliance with its minimum liquidity debt covenant within the next twelve months - The company believes its existing cash, cash equivalents, and marketable securities as of March 31, 2021, combined with the **$11.5 million Torii payment**, will be sufficient to support planned operations at least through the **second quarter of 2023**[97](index=97&type=chunk)[139](index=139&type=chunk) - The company raised net proceeds of **$28.1 million** from a follow-on public offering in March 2021[119](index=119&type=chunk) - Management believes it is probable that the company will not be in compliance with its **minimum liquidity ratio covenant** at some point in the next twelve months, which has led to the classification of its debt as a **current liability**[130](index=130&type=chunk) [Quantitative and Qualitative Disclosures About Market Risks](index=27&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risks) The company states that there have been no material changes to its quantitative and qualitative disclosures about market risk from those previously disclosed in its Annual Report on Form 10-K for the fiscal year ended December 31, 2020 - There have been **no material changes** to the company's market risk disclosures since the last Annual Report on Form 10-K[147](index=147&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of March 31, 2021. No material changes to internal control over financial reporting were identified during the quarter - The CEO and CFO concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2021[148](index=148&type=chunk) - There were **no changes in internal control over financial reporting** during the quarter that materially affected, or are reasonably likely to materially affect, these controls[152](index=152&type=chunk) [PART II. OTHER INFORMATION](index=27&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=27&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings and is not aware of any pending or threatened legal actions that could have a material adverse effect on its business or financial condition - The company is **not currently involved in any material legal proceedings**[153](index=153&type=chunk) [Risk Factors](index=27&type=section&id=Item%201A.%20Risk%20Factors) The company states there have been no material changes to the risk factors previously disclosed in its 2020 Annual Report on Form 10-K. A summary of key risks is provided, covering areas such as financial position, product development, commercialization, dependence on third parties, and intellectual property - There have been **no material changes** to the risk factors described in the Annual Report for the fiscal year ended December 31, 2020[154](index=154&type=chunk) - Key risk categories include: - Financial Position and Capital Needs (history of losses, need for additional funding) - Product Candidate Development (reliance on VP-102 success) - Commercialization (competition, reimbursement challenges) - Dependence on Third Parties (raw material supply, collaborations) - Intellectual Property (ability to obtain and protect patents)[155](index=155&type=chunk)[156](index=156&type=chunk)[162](index=162&type=chunk) [Recent Sales of Unregistered Securities and Use of Proceeds](index=30&type=section&id=Item%202.%20Recent%20Sales%20of%20Unregistered%20Securities%20and%20Use%20of%20Proceeds) The company reports no recent sales of unregistered equity securities during the period - There were **no sales of unregistered equity securities** in the reported period[164](index=164&type=chunk) [Exhibits](index=30&type=section&id=Item%206.%20Exhibits) This section lists the exhibits filed with the Form 10-Q, most notably the Collaboration and License Agreement with Torii Pharmaceutical Co., Ltd., and the required CEO and CFO certifications under the Sarbanes-Oxley Act - Key exhibits filed include the **Collaboration and License Agreement with Torii Pharmaceutical Co., Ltd.**, dated March 17, 2021, and officer certifications[172](index=172&type=chunk)
Verrica Pharmaceuticals(VRCA) - 2020 Q4 - Annual Report
2021-03-17 20:23
[PART I](index=5&type=section&id=PART%20I) Overview of the company's business, operations, and associated risks [Business](index=5&type=section&id=ITEM%201.%20BUSINESS) Verrica Pharmaceuticals is a clinical-stage dermatology therapeutics company focused on developing and commercializing treatments for skin diseases [Overview](index=5&type=section&id=Overview) Key product candidate VP-102 targets molluscum and warts, with an NDA resubmission and strategic collaborations - Verrica's lead product candidate, VP-102, is a proprietary drug-device combination for treating molluscum contagiosum and common warts, both of which have no FDA-approved treatments[13](index=13&type=chunk) - The company resubmitted its New Drug Application (NDA) for VP-102 for molluscum in December 2020, and the FDA has set a PDUFA goal date of June 23, 2021; the initial Complete Response Letter (CRL) cited Chemistry, Manufacturing, and Controls (CMC) and human factors issues, with no clinical deficiencies[14](index=14&type=chunk) - Verrica entered into a collaboration with Torii Pharmaceutical to develop and commercialize cantharidin-based products in Japan, receiving an **$11.5 million upfront payment** and eligibility for up to **$58.0 million in milestones**[17](index=17&type=chunk)[18](index=18&type=chunk) - The company licensed LTX-315 from Lytix Biopharma for dermatological oncology and plans to submit an Investigational New Drug (IND) application in the first half of 2021[19](index=19&type=chunk) - The estimated total addressable U.S. market for molluscum is over **$1 billion**, affecting an estimated **6 million people**[21](index=21&type=chunk) [Our Pipeline](index=8&type=section&id=Our%20Pipeline) Overview of the company's product candidates and their current development phases Product Candidate Pipeline Status | Product Candidate | Indication | Pre-IND | Phase 2 | Phase 3 | NDA | Next Expected Milestone | | :--- | :--- | :--- | :--- | :--- | :--- | :--- | | **VP-102 (YCANTH)** | Molluscum Contagiosum | | | ✓ | ✓ | PDUFA Goal Date: June 23, 2021 | | | Common Warts | | ✓ | | | Evaluate potential second Phase 2 trial | | | External Genital Warts | | ✓ | | | End-of-Phase 2 meeting in Q2 2021 | | **VP-103** | Plantar Warts | ✓ | | | | Initiate Phase 2 trial | | **LTX-315** | Dermatological Oncology | ✓ | | | | Submit US IND during 1H 2021 | [Clinical Development Program](index=8&type=section&id=Clinical%20Development%20Program) Summary of clinical trial results and development plans for lead product candidates - In two pivotal Phase 3 trials (CAMP-1 and CAMP-2), VP-102 demonstrated statistically significant complete clearance of all treatable molluscum lesions compared to placebo (**46% and 54% vs. 18% and 13%**, respectively; p<0.0001)[41](index=41&type=chunk)[42](index=42&type=chunk) - The Phase 2 COVE-1 trial for common warts showed positive results, with Cohort 2 (which allowed for wart paring) achieving a **51.4% complete clearance rate** at Day 84[51](index=51&type=chunk) - Following positive topline results from the Phase 2 trial of VP-102 for external genital warts in November 2020, the company requested an end-of-Phase 2 meeting with the FDA in Q1 2021[27](index=27&type=chunk)[54](index=54&type=chunk) - The company is developing VP-103 for plantar warts and LTX-315 for dermatological oncology, with plans to initiate a Phase 2 trial for VP-103 and submit an IND for LTX-315 in the first half of 2021[28](index=28&type=chunk)[29](index=29&type=chunk)[58](index=58&type=chunk) [Manufacturing](index=13&type=section&id=Manufacturing) Reliance on third-party manufacturers and a single-source supplier for key raw materials - Verrica does not own manufacturing facilities and relies on third-party contractors for the manufacture of its product candidates[59](index=59&type=chunk) - The company has a five-year supply agreement with a Chinese supplier for naturally-sourced cantharidin, which grants Verrica exclusivity for the raw material in North America[60](index=60&type=chunk)[62](index=62&type=chunk) - As of January 31, 2021, the company possessed sufficient raw cantharidin and API to produce over **14 million finished drug product applicators**[61](index=61&type=chunk) [Commercialization](index=14&type=section&id=Commercialization) Plans for U.S. sales force and anticipated market access for VP-102 - The company plans to build a specialized U.S. sales force of approximately **50 to 60 representatives** to target dermatologists and pediatricians[67](index=67&type=chunk) - A market research study surveying payors representing over **105 million lives** indicated that, given the unmet need, the majority of patients would likely have access to VP-102 with minimal restrictions if approved[68](index=68&type=chunk) [Competition](index=14&type=section&id=Competition) Competitive landscape for molluscum and warts, including existing and pipeline therapies - There are currently no FDA-approved prescription therapies for molluscum, common warts, or plantar warts; competition includes off-label therapies, cryotherapy, curettage, and compounded cantharidin[70](index=70&type=chunk) - If VP-102 is approved, compounding of similar cantharidin products may be restricted under FDCA Sections 503A and 503B, though exceptions for individual patient needs could still allow for competition[70](index=70&type=chunk) - Several other companies are developing potential treatments for molluscum (Veloce Biopharma, Leo Pharma, Novan) and common warts (Aclaris Therapeutics)[72](index=72&type=chunk) [Intellectual Property](index=15&type=section&id=Intellectual%20Property) Overview of patent portfolio, licensing agreements, and associated financial terms - The company's patent portfolio covers cantharidin formulations, applicator devices, and methods of use, but not the cantharidin molecule itself; utility patents from pending applications are projected to expire between **2034 and 2041**[74](index=74&type=chunk)[75](index=75&type=chunk) - Verrica obtained an exclusive worldwide license from Lytix Biopharma for LTX-315, with financial terms including upfront/milestone payments of **$2.5 million**, up to **$111.0 million in future milestones**, and tiered royalties[79](index=79&type=chunk)[80](index=80&type=chunk) - The company granted Torii Pharmaceutical an exclusive license for cantharidin-based products in Japan, for which Verrica will receive an **$11.5 million upfront payment**, up to **$58.0 million in milestones**, and tiered transfer price payments[83](index=83&type=chunk)[85](index=85&type=chunk) [Government Regulation and Product Approval](index=17&type=section&id=Government%20Regulation%20and%20Product%20Approval) Regulatory framework for drug-device combination products and compliance with healthcare laws - VP-102 is regulated as a drug-device combination product, requiring review coordination between the FDA's Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH)[90](index=90&type=chunk) - The company may be entitled to **five years of non-patent exclusivity** if VP-102's active ingredient is characterized as a New Chemical Entity (NCE), with a potential **six-month pediatric extension**[113](index=113&type=chunk) - The business is subject to extensive healthcare laws, including the federal Anti-Kickback Statute, False Claims Act, HIPAA, and the Physician Payments Sunshine Act, which govern interactions with healthcare providers and payors[128](index=128&type=chunk)[129](index=129&type=chunk)[134](index=134&type=chunk)[136](index=136&type=chunk) - The Affordable Care Act (ACA) and other healthcare reform initiatives continue to create an uncertain environment regarding drug pricing, reimbursement, and market access[146](index=146&type=chunk)[147](index=147&type=chunk) [Risk Factors](index=30&type=section&id=ITEM%201A.%20RISK%20FACTORS) The company faces substantial financial, operational, and regulatory risks, including significant losses, capital needs, reliance on VP-102 approval, supply chain dependencies, and intense competition [Risks Related to Financial Position and Capital Needs](index=31&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) Significant historical losses, limited cash runway, and debt covenants pose financial challenges - The company has a history of significant losses, with a net loss of **$42.7 million** in 2020 and an accumulated deficit of **$103.9 million** as of December 31, 2020; it has never generated revenue and expects to incur losses for the next several years[168](index=168&type=chunk) - Existing cash is expected to fund operations only through the first quarter of 2022, and substantial additional funding will be required to meet objectives[176](index=176&type=chunk)[180](index=180&type=chunk) - The company has **$40.0 million in debt** with restrictive covenants, including a minimum liquidity requirement that it may not be able to meet without additional financing, which could lead to debt acceleration[187](index=187&type=chunk)[188](index=188&type=chunk)[190](index=190&type=chunk) [Risks Related to Product Development](index=35&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) Uncertainty and complexity of clinical trials and regulatory approval for drug-device combination products - The company's business is highly dependent on the successful development, regulatory approval, and commercialization of its lead product candidate, VP-102[191](index=191&type=chunk) - Clinical development is a lengthy, expensive, and uncertain process; delays in trials, patient enrollment difficulties, or unfavorable results could prevent or delay marketing approval[195](index=195&type=chunk)[199](index=199&type=chunk)[203](index=203&type=chunk) - VP-102 is a drug-device combination product, which may result in a more complex and lengthy regulatory review process due to the need for coordination between different FDA centers[218](index=218&type=chunk) [Risks Related to Commercialization](index=43&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) Challenges in market acceptance, competition from existing therapies, and securing adequate reimbursement - Even if approved, VP-102 may fail to achieve market acceptance from physicians, patients, and payors[232](index=232&type=chunk) - The company faces substantial competition from existing treatments, off-label products, and compounded cantharidin, which may still be available under certain conditions even after VP-102's approval[238](index=238&type=chunk)[240](index=240&type=chunk) - Commercial success is highly dependent on obtaining adequate coverage and reimbursement from third-party payors, which is uncertain and may be difficult to secure[251](index=251&type=chunk) [Risks Related to Dependence on Third Parties](index=48&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Reliance on single-source suppliers and contract organizations introduces supply chain and operational risks - The company relies on a single supplier based in the People's Republic of China for its raw material, naturally-sourced cantharidin, posing significant supply chain, environmental, and geopolitical risks[273](index=273&type=chunk)[276](index=276&type=chunk) - The COVID-19 pandemic has already caused delays in planned clinical trials for common warts and plantar warts and could continue to adversely impact the business[279](index=279&type=chunk) - Verrica relies on third-party contract manufacturers for its products and CROs for its clinical trials, which reduces direct control over these critical functions and introduces risks related to performance, compliance, and cost[266](index=266&type=chunk)[282](index=282&type=chunk) [Risks Related to Intellectual Property](index=54&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Limited patent protection for the active ingredient and potential for costly intellectual property litigation - The active ingredient, cantharidin, is a naturally occurring compound and its composition of matter is not patentable; patent protection is limited to specific formulations, devices, and methods of use, which may allow competitors to develop non-infringing alternatives[315](index=315&type=chunk) - The company may become involved in expensive and time-consuming lawsuits to protect its patents or defend against claims that it is infringing on the intellectual property rights of others[317](index=317&type=chunk)[321](index=321&type=chunk) [Risks Related to Legal and Regulatory Compliance Matters](index=61&type=section&id=Risks%20Related%20to%20Legal%20and%20Regulatory%20Compliance%20Matters) Extensive healthcare laws, promotion regulations, and evolving pricing scrutiny pose compliance and market access risks - The company's business is subject to extensive federal and state healthcare laws, including anti-kickback, false claims, and privacy regulations; violations can lead to substantial penalties[332](index=332&type=chunk) - The FDA strictly regulates the promotion of prescription products, and any improper promotion of off-label uses could result in significant liability[338](index=338&type=chunk) - Ongoing healthcare reform and heightened scrutiny of pharmaceutical pricing create an uncertain regulatory environment that could negatively impact the company's ability to profitably sell its products[344](index=344&type=chunk)[349](index=349&type=chunk) [Risks Related to Employee Matters and Managing Our Growth](index=67&type=section&id=Risks%20Related%20to%20Employee%20Matters%20and%20Managing%20Our%20Growth) Dependence on key personnel and challenges in managing organizational expansion - The company is highly dependent on its key executives and scientific personnel and faces intense competition in recruiting and retaining qualified individuals[355](index=355&type=chunk)[356](index=356&type=chunk) - Expected expansion of operations and employee headcount may create difficulties in managing growth effectively[357](index=357&type=chunk) [Risks Related to Ownership of Common Stock](index=68&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock%20and%20Our%20Status%20as%20a%20Public%20Company) Stock price volatility, concentrated ownership, and reduced disclosure as an emerging growth company - The company's stock price may be volatile, and a substantial portion of its common stock is concentrated among executive officers, directors, and principal stockholders, which may limit the influence of other stockholders[360](index=360&type=chunk)[369](index=369&type=chunk) - As an "emerging growth company," Verrica is permitted to have reduced disclosure and governance requirements, which may make its stock less attractive to some investors[371](index=371&type=chunk) - A material weakness in IT general controls was identified in 2019 and remediated as of December 31, 2020[377](index=377&type=chunk)[599](index=599&type=chunk) [Properties](index=74&type=section&id=ITEM%202.%20PROPERTIES) The company leases office space in West Chester, Pennsylvania; it entered into a new seven-year lease for 11,201 square feet of office space to serve as its new headquarters, with the lease commencing on September 1, 2020 - The company entered into a new seven-year lease for **11,201 square feet** of office space in West Chester, PA, which commenced on September 1, 2020, to serve as its new headquarters[393](index=393&type=chunk) [Legal Proceedings](index=74&type=section&id=ITEM%203.%20LEGAL%20PROCEEDINGS) A putative class action lawsuit filed against the company and certain executive officers in July 2020, alleging federal securities law violations, was voluntarily dismissed by the plaintiff in December 2020 - A putative class action complaint filed against the company on July 14, 2020, was voluntarily dismissed with prejudice as to the plaintiff on December 21, 2020[395](index=395&type=chunk) [PART II](index=75&type=section&id=PART%20II) Financial performance, capital resources, and market information for the company's common equity [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=75&type=section&id=ITEM%205.%20MARKET%20FOR%20REGISTRANT%27S%20COMMON%20EQUITY%2C%20RELATED%20STOCKHOLDER%20MATTERS%20AND%20ISSUER%20PURCHASES%20OF%20EQUITY%20SECURITIES) Verrica's common stock trades on the Nasdaq Global Select Market under the symbol "VRCA"; the company has never paid cash dividends and does not plan to in the foreseeable future, partly due to restrictions in its loan agreements; in December 2020, the company repurchased 424,429 shares of its common stock from a former executive - The company has never declared or paid cash dividends and does not anticipate doing so; its loan agreements also restrict dividend payments[399](index=399&type=chunk) - In December 2020, the company repurchased **424,429 shares** of common stock from its former Chief Scientific Officer at a price of **$0.0001714 per share**[404](index=404&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=76&type=section&id=ITEM%207.%20MANAGEMENT%27S%20DISCUSSION%20AND%20ANALYSIS%20OF%20FINANCIAL%20CONDITION%20AND%20RESULTS%20OF%20OPERATIONS) Verrica reported a net loss of $42.7 million for 2020, an increase from $28.2 million in 2019, driven by higher G&A expenses related to stock-based compensation and pre-commercial activities for VP-102; the company ended 2020 with $65.5 million in cash, cash equivalents, and marketable securities; it secured a debt facility in March 2020, drawing $35.0 million; management believes existing cash, combined with an $11.5 million upfront payment from its Torii collaboration, will fund operations at least through the first quarter of 2022, but notes it is probable the company will not meet a minimum liquidity covenant on its debt without additional financing [Results of Operations](index=81&type=section&id=Results%20of%20Operations) Analysis of operating expenses and net loss for the fiscal year 2020 compared to 2019 Results of Operations (in thousands) | | For the Year Ended December 31, | Change | | :--- | :--- | :--- | :--- | | | **2020** | **2019** | **($)** | | **Operating expenses:** | | | | | Research and development | $15,673 | $15,436 | $237 | | General and administrative | $24,508 | $14,644 | $9,864 | | **Total operating expenses** | **$40,181** | **$30,080** | **$10,101** | | **Loss from operations** | **($40,181)** | **($30,080)** | **($10,101)** | | Interest income | $521 | $1,877 | ($1,356) | | Interest expense | ($3,033) | $— | ($3,033) | | **Net loss** | **($42,694)** | **($28,207)** | **($14,487)** | - General and administrative expenses increased by **$9.9 million** in 2020, primarily due to higher stock-based compensation costs (including a **$4.8 million modification expense**), increased headcount, and pre-commercial activities for VP-102[440](index=440&type=chunk) - Research and development expenses remained relatively flat, increasing by **$0.2 million** to **$15.7 million** in 2020[439](index=439&type=chunk) [Liquidity and Capital Resources](index=82&type=section&id=Liquidity%20and%20Capital%20Resources) Overview of cash position, debt obligations, and future funding requirements - As of December 31, 2020, the company had **$65.5 million** in cash, cash equivalents, and marketable securities[446](index=446&type=chunk) - In March 2020, the company entered into a loan agreement and borrowed **$35.0 million** in term loans; an additional **$5.0 million** was borrowed on March 1, 2021[447](index=447&type=chunk)[448](index=448&type=chunk) - The loan agreement contains a minimum liquidity covenant; the company has classified the entire debt as a current liability because it believes it is probable that it will not be in compliance with this covenant at some point in the next twelve months without additional financing[458](index=458&type=chunk) Cash Flow Summary (in thousands) | | For the Year Ended December 31, | | :--- | :--- | :--- | | | **2020** | **2019** | | Net cash used in operating activities | ($30,207) | ($27,408) | | Net cash (used in) provided by investing activities | ($3,580) | $25,955 | | Net cash provided by financing activities | $35,232 | $423 | [Financial Statements and Supplementary Data](index=88&type=section&id=ITEM%208.%20FINANCIAL%20STATEMENTS%20AND%20SUPPLEMENTARY%20DATA) This section contains the company's audited financial statements for the fiscal years ended December 31, 2020 and 2019, as audited by KPMG LLP; key financial data includes a net loss of $42.7 million for 2020, total assets of $74.2 million, and total liabilities of $41.2 million as of year-end 2020; the accompanying notes detail significant accounting policies, debt obligations, stock-based compensation, and recent collaboration agreements [Financial Statements](index=89&type=section&id=Financial%20Statements) Summary of key financial data from the balance sheet and statement of operations Key Financial Data (as of and for the year ended Dec 31, 2020, in thousands) | Metric | Amount | | :--- | :--- | | **Balance Sheet:** | | | Cash and cash equivalents | $10,686 | | Total assets | $74,154 | | Current debt, net | $35,315 | | Total liabilities | $41,168 | | Total stockholders' equity | $32,986 | | **Statement of Operations:** | | | Total operating expenses | $40,181 | | Net loss | ($42,694) | | Net loss per share | ($1.71) | [Notes to Financial Statements](index=94&type=section&id=Notes%20to%20Financial%20Statements) Details on debt covenants, stock-based compensation, and significant collaboration agreements - The company's debt agreement includes a minimum liquidity covenant; management believes it is probable this covenant will not be met in the next twelve months without additional financing, leading to the classification of all outstanding debt as a current liability[502](index=502&type=chunk)[578](index=578&type=chunk) - In December 2020, an agreement with the former Chief Scientific Officer was modified, resulting in the immediate recognition of **$4.8 million** in stock-based compensation expense[559](index=559&type=chunk) - In March 2021, the company entered into a collaboration and license agreement with Torii Pharmaceutical, which includes an **$11.5 million upfront payment** and up to **$58 million in potential milestones**[588](index=588&type=chunk)[589](index=589&type=chunk) - In August 2020, the company entered into an exclusive license agreement with Lytix Biopharma, paying a **$0.3 million upfront fee** and committing to potential future milestones of up to **$111.0 million** plus royalties[591](index=591&type=chunk) [Controls and Procedures](index=109&type=section&id=ITEM%209A.%20CONTROLS%20AND%20PROCEDURES) Management concluded that the company's disclosure controls and procedures were effective as of December 31, 2020; a material weakness in information technology (IT) general controls related to segregation of duties, which was identified in 2019, was successfully remediated during 2020 - A material weakness in IT general controls, first disclosed in the 2019 Form 10-K, was remediated as of December 31, 2020[598](index=598&type=chunk)[599](index=599&type=chunk) - The remediation plan involved transferring key administrative access for an IT system to a third-party IT vendor[599](index=599&type=chunk)[602](index=602&type=chunk) - Based on their evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective as of December 31, 2020[594](index=594&type=chunk) [PART III](index=110&type=section&id=PART%20III) Information on corporate governance, executive compensation, and security ownership [Directors, Executive Officers and Corporate Governance](index=110&type=section&id=ITEM%2010.%20DIRECTORS%2C%20EXECUTIVE%20OFFICERS%20AND%20CORPORATE%20GOVERNANCE) Information regarding directors, executive officers, and corporate governance is incorporated by reference from the company's definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's 2021 Proxy Statement[607](index=607&type=chunk) [Executive Compensation](index=110&type=section&id=ITEM%2011.%20EXECUTIVE%20COMPENSATION) Information regarding executive and director compensation is incorporated by reference from the company's definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's 2021 Proxy Statement[607](index=607&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=110&type=section&id=ITEM%2012.%20SECURITY%20OWNERSHIP%20OF%20CERTAIN%20BENEFICIAL%20OWNERS%20AND%20MANAGEMENT%20AND%20RELATED%20STOCKHOLDER%20MATTERS) Information regarding security ownership and equity compensation plans is incorporated by reference from the company's definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's 2021 Proxy Statement[608](index=608&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=110&type=section&id=ITEM%2013.%20CERTAIN%20RELATIONSHIPS%20AND%20RELATED%20TRANSACTIONS%2C%20AND%20DIRECTOR%20INDEPENDENCE) Information regarding related party transactions and director independence is incorporated by reference from the company's definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's 2021 Proxy Statement[608](index=608&type=chunk) [Principal Accountant Fees and Services](index=110&type=section&id=ITEM%2014.%20PRINCIPAL%20ACCOUNTING%20FEES%20AND%20SERVICES) Information regarding principal accountant fees and services is incorporated by reference from the company's definitive Proxy Statement for its 2021 Annual Meeting of Stockholders - The information required by this item is incorporated by reference from the company's 2021 Proxy Statement[609](index=609&type=chunk) [PART IV](index=111&type=section&id=PART%20IV) Listing of exhibits and financial statement schedules filed with the annual report [Exhibits and Financial Statement Schedules](index=111&type=section&id=ITEM%2015.%20EXHIBITS%20AND%20FINANCIAL%20STATEMENT%20SCHEDULES) This section lists the exhibits filed as part of the Annual Report, including corporate governance documents, material contracts such as loan agreements and license agreements, and certifications required by the Sarbanes-Oxley Act - This section contains a list of all exhibits filed with the Form 10-K, including the company's certificate of incorporation, bylaws, material contracts, and required certifications[610](index=610&type=chunk)[611](index=611&type=chunk)
Verrica Pharmaceuticals(VRCA) - 2020 Q3 - Quarterly Report
2020-11-09 13:51
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) Verrica Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 46-3137900 (State or other jurisdiction of incorporation or organization) 10 North High Street, Suite 200 West Chester, PA 19380 (Address of principal executive offices) (Zip Code) (I.R.S. Employer Identification No.) Registrant's telephone number, including area code: (484) 453-3300 ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 O ...
Verrica Pharmaceuticals(VRCA) - 2020 Q2 - Quarterly Report
2020-08-05 12:13
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38529 Verrica Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 46-3137900 (State or other juri ...
Verrica Pharmaceuticals (VRCA) Investor Presentation - Slideshow
2020-06-03 22:13
Company Overview June 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. DISCLAIMER Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Verrica's own internal estimates and research. While Verrica believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no re ...
Verrica Pharmaceuticals (VRCA) Investor Presentation - Slideshow
2020-05-20 19:54
Investment Highlights - Verrica addresses two large unmet needs in dermatology: molluscum contagiosum with a prevalence of approximately 6 million in the US, and common warts with a prevalence of approximately 22 million in the US[12, 161] - Ycanth™ (VP-102) has a PDUFA goal date of July 13, 2020, for the treatment of molluscum contagiosum[12, 157, 161] - Phase 3 trials for Ycanth™ (VP-102) in molluscum contagiosum achieved statistical significance for primary endpoints with a p-value < 00001 in both pivotal trials[12, 161] - VP-102 achieved positive topline Phase 2 results in common warts, demonstrating complete clearance of all treatable warts at Week 12 (Day 84)[12, 161] Clinical Trial Results - In Phase 3 molluscum trials, 50% of patients treated with VP-102 achieved complete clearance of molluscum lesions at Day 84, compared to 168% in the vehicle group (P < 00001)[71] - Phase 3 molluscum trials also demonstrated a statistically significant efficacy on percent reduction of lesions, with VP-102 showing a -76% change from baseline to Day 84 compared to -59% for the vehicle group (P < 00001)[74] - In the COVE-1 study for common warts, VP-102 demonstrated clinically meaningful efficacy on the primary endpoint of complete clearance, with 40% to 514% clearance depending on the cohort at EOS/EOT (Day 84)[121] Commercial Opportunity - In the US, approximately 6 million people have molluscum, with approximately 1 million diagnosed annually[12, 21, 84, 161] - Approximately 87% of physicians reported they would use Ycanth™ (VP-102) if the cost of the drug was covered[89] - Initial payer research suggests a favorable reimbursement landscape for Ycanth™ (VP-102), with interviewed payer organizations and plans covering a total of 105 million commercial & Medicaid lives[93, 97]
Verrica Pharmaceuticals(VRCA) - 2020 Q1 - Quarterly Report
2020-05-07 11:29
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38529 Verrica Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) (State or other jurisdiction of incorpo ...
Verrica Pharmaceuticals (VRCA) Investor Presentation - Slideshow
2020-03-18 18:27
Company Overview March 2020 Copyright © 2020 Verrica Pharmaceuticals. All rights reserved. DISCLAIMER Certain information contained in this presentation and statements made orally during this presentation relates to or is based on studies, publications, surveys and other data obtained from third-party sources and Verrica's own internal estimates and research. While Verrica believes these third-party sources to be reliable as of the date of this presentation, it has not independently verified, and makes no r ...
Verrica Pharmaceuticals(VRCA) - 2019 Q4 - Annual Report
2020-03-13 20:17
UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-38529 Verrica Pharmaceuticals Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware 46-3137900 | | | | | --- | --- | --- | --- | | (State or other juri ...