On March 2, 2022 Verrica Pharmaceuticals Inc. (Verrica) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the fourth quarter and year ended December 31, 2021 (Press release, Verrica Pharmaceuticals, MAR 2, 2022, View Source [SID1234609381]).
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"2022 is poised to be an exciting year for Verrica as we prepare to potentially launch VP-102 this summer for the treatment of molluscum, a disease affecting an estimated six million patients with no approved treatments, representing a significant market opportunity," said Ted White, Verrica’s President and Chief Executive Officer. "In addition, in keeping with our mission to develop treatments for the most significant unmet needs in medical dermatology, we are rapidly advancing LTX-315, a novel immunotherapy for the treatment of non-melanoma skin cancers. The first patient is expected to be dosed in the Phase 2 trial evaluating LTX-315 in basal cell carcinoma in the first quarter of 2022."
Business Highlights and Recent Developments
VP-102
On November 29, 2021, Verrica announced that it resubmitted the New Drug Application (NDA) for VP-102 for the treatment of molluscum contagiosum (molluscum) to the U.S. Food and Drug Administration (FDA). On December 15, 2021, Verrica announced that the FDA acknowledged that Verrica’s resubmitted NDA was complete and assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 24, 2022.
LTX-315
Verrica expects to dose the first patient in the Phase 2 clinical trial of LTX-315 for the treatment of basal cell carcinoma in the first quarter of 2022. LTX-315 is a potentially first-in-class oncolytic peptide immunotherapy in development as a non-surgical treatment option for non-melanoma skin cancers. The Phase 2 trial is a three-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of LTX-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 66 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.
Corporate Highlights
On March 1, 2022, Verrica amended its existing $40 million credit facility led by Silicon Valley Bank. The amendment provides Verrica increased financial flexibility by extending the interest-only payment period and reducing the minimum cash Verrica is required to maintain on its balance sheet.
Financial Results
Fourth Quarter 2021 Financial Results
Verrica reported a net loss of $9.5 million for the fourth quarter of 2021, compared to a $13.0 million loss for the same period in 2020.
Research and development expenses were $3.4 million in the fourth quarter of 2021, compared to $2.3 million for the same period in 2020. The increase was primarily attributable to higher Chemistry, Manufacturing, and Controls (CMC).
General and administrative expenses were $5.1 million in the fourth quarter of 2021, compared to $9.8 million for the same period in 2020. The decrease was primarily due to higher stock-based compensation expense recorded in December 2020, which includes $4.8 million of stock-based compensation expense related to the modification of a stock award to a former executive partially offset by an increase in expenses due to increased headcount, an increase in insurance, and other operating costs.
Full Year 2021 Financial Results
Verrica recognized license revenues of $12.0 million for the year ended December 31, 2021 related to the Collaboration and License Agreement (Torii Agreement) with Torii Pharmaceutical Col, Ltd (Torii). There were no license revenues recognized in 2020.
Research and development expenses were $15.9 million for the year ended December 31, 2021, compared to $15.7 million for the same period in 2020. The increase was primarily attributable to a one-time $2.3 million milestone payment to Lytix Biopharma AS upon the achievement of a regulatory milestone for LTX-315 and increased compensation costs related to higher headcount and increased clinical costs related to Verrica’s development of VP-102 for molluscum partially offset by decreased CMC costs related to Verrica’s development of VP-102 for molluscum contagiosum
General and administrative expenses were $27.0 million for the year ended December 31, 2021, compared to $24.5 million for the same period in 2020. 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. The increase was partially offset by a decrease in stock-based compensation costs, which includes $4.8 million of stock-based compensation expense recorded in December 2020 related to the modification of a stock award to a former executive.
For the year ended December 31, 2021, net loss on a GAAP basis was $35.1 million, or $1.30 per share, compared to a net loss of $42.7 million, or $1.71 per share, for the same period in 2020.
For the year ended December 31, 2021, non-GAAP net loss was $27.6 million, or $1.02 per share, compared to a non-GAAP net loss of $31.9 million, or $1.28 per share, for the same period in 2020.
As of December 31, 2021, Verrica had aggregate cash, cash equivalents, and marketable securities of $70.4 million. Verrica believes that its existing cash, cash equivalents, and marketable securities as of December 31, 2021 will be sufficient to support planned operations into the third quarter of 2022.
Non-GAAP Financial Measures
In evaluating the operating performance of its business, Verrica’s management considers non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share. These non-GAAP financial measures exclude stock-based compensation charges and non-cash interest expense that are required by GAAP. Verrica believes that non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share provides useful information to both management and investors by excluding the effect of certain non-cash expenses and items that Verrica believes may not be indicative of its operating performance, because either they are unusual and Verrica does not expect them to recur in the ordinary course of its business, or they are unrelated to the ongoing operation of the business in the ordinary course. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. Non-GAAP loss from operations, non-GAAP net loss and non-GAAP net loss per share have been reconciled to the nearest GAAP measure in the tables following the financial statements in this press release.
About VP-102
Verrica’s lead product candidate, VP-102, is a proprietary drug-device combination product that contains a GMP-controlled formulation of cantharidin (0.7% w/v) delivered via a single-use applicator that allows for precise topical dosing and targeted administration. VP-102 is currently under U.S. Food and Drug Administration (FDA) review and could potentially be the first product approved by the FDA to treat molluscum contagiosum — a common, highly contagious skin disease that affects an estimated six million people in the United States, primarily children. If approved, VP-102 will be marketed in the United States under the conditionally accepted brand name YCANTH. In addition, Verrica has successfully completed a Phase 2 study of VP-102 for the treatment of common warts and a Phase 2 study of VP-102 for the treatment of external genital warts.
About Molluscum Contagiosum (Molluscum)
There are currently no FDA-approved treatments for molluscum, a highly contagious viral skin disease that affects approximately six million people — primarily children — in the United States. Molluscum is caused by a pox virus that produces distinctive raised, skin-toned-to-pink-colored lesions that can cause pain, inflammation, itching and bacterial infection. It is easily transmitted through direct skin-to-skin contact or through fomites (objects that carry the disease like toys, towels or wet surfaces) and can spread to other parts of the body or to other people, including siblings. The lesions can be found on most areas of the body and may carry substantial social stigma. Without treatment, molluscum can last for an average of 13 months, and in some cases, up to several years.