On November 9, 2020 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the third quarter ended September 30, 2020 (Press release, Verrica Pharmaceuticals, NOV 9, 2020, View Source [SID1234570465]).
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"We are encouraged by our recent Type A meeting with the FDA in which we discussed the steps required for resubmission of the NDA for VP-102, our lead product candidate, for the treatment of molluscum," said Ted White, Verrica’s President and Chief Executive Officer. "We have also received feedback from the FDA on our Human Factors study protocol, and believe we have clear alignment on the path forward to resubmit the NDA, which we anticipate in the first quarter of 2021. In addition, we have continued to engage with Torii as they evaluate the option to exclusively license VP-102 in Japan for the treatment of molluscum contagiosum and common warts. We also strategically expanded our product portfolio into dermatologic cancers, with an initial focus on non-melanoma skin cancers, one of the most common disease states in dermatology."
Business Highlights and Recent Developments
In October 2020, Verrica participated in a Type A meeting with the FDA to discuss issues raised in the Complete Response Letter for the NDA for VP-102 for the treatment of molluscum. Verrica expects to receive the minutes from the meeting in the coming weeks, followed by resubmission of the NDA pursuant to the statutory 505(b)(1) regulatory pathway in the first quarter of 2021.
The positive results from the Company’s two pivotal Phase 3 CAMP studies evaluating the safety and efficacy of VP-102 in children and adults with molluscum were published in the Journal of the American Medical Association (JAMA) Dermatology on September 23, 2020. The results were previously presented at the 2019 American Academy of Dermatology (AAD) annual meeting in a late-breaking oral presentation.
In August 2020, Verrica was granted a United States utility patent (US 10,745,413) protecting synthetic methods for manufacturing cantharidin. Also in August 2020, a U.S. design patent application protecting the design of Verrica’s VP-102 applicator device received an allowance from the United States Patent and Trademark Office (USPTO). The resulting United States design patent (US D900,312) was granted in October 2020.
Financial Results
Third Quarter 2020 Financial Results
Verrica reported a net loss of $10.5 million for the third quarter of 2020, compared to a $6.1 million net loss for the same period in 2019.
Research and development expenses were $5.0 million in the third quarter of 2020, compared to $3.0 million for the same period in 2019. The increase was primarily attributable to increased CMC (Chemistry, Manufacturing, and Controls) costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum, external genital warts, and common warts.
General and administrative expenses were $4.6 million in the third quarter of 2020, compared to $3.5 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
Year-to-Date September 2020 Financial Results
Verrica reported a net loss of $29.7 million for the nine months ended September 30, 2020, compared to a $20.6 million net loss for the same period in 2019.
Research and development expenses were $13.4 million for the nine months ended September 30, 2020, compared to $11.5 million for the same period in 2019. The increase was primarily attributable to increased CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum and increased compensation costs, partially offset by decreased clinical costs related to Verrica’s development of VP-102 for molluscum contagiosum.
General and administrative expenses were $14.7 million for the nine months ended September 30, 2020, compared to $10.6 million for the same period in 2019. The increase was primarily a result of expenses related to increased headcount, an increase in insurance, professional fees and other operating costs, and an increase in expenses related to pre-commercial activities for VP-102.
As of September 30, 2020, Verrica had aggregate cash, cash equivalents, and marketable securities of $71.9 million, which the Company believes will be sufficient to support planned operations at least through the fourth quarter of 2021.