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Jun 30, 2020
Verrica Q2 2020 Earnings Report
Verrica reported a net loss for Q2 2020, with key leadership additions and progress on VP-102 regulatory resubmission.
Key Takeaways
Verrica Pharmaceuticals reported a net loss of $9.4 million for the second quarter of 2020. The company is focusing on resubmitting the New Drug Application for VP-102 and strengthened its leadership team. They also entered into an option agreement with Torii Pharmaceutical for VP-102 in Japan.
Verrica received a Complete Response Letter from the FDA for VP-102 NDA and plans to request a Type A meeting with the FDA in Q3 2020.
Key personnel changes were made to strengthen expertise in clinical, CMC, and regulatory affairs.
An option agreement was signed with Torii Pharmaceutical for the development and commercialization of VP-102 in Japan.
Two new pooled analyses of the Phase 3 CAMP trials of VP-102 in molluscum were presented at the virtual American Academy of Dermatology 2020 Annual Meeting.
Forward Guidance
Verrica is focused on resubmitting the NDA for VP-102 and advancing its pipeline.
Positive Outlook
- Company expects to discuss with the FDA regarding the issues raised in the CRL and the Company’s plans to address them
- Potential approval of the NDA for VP-102 following resubmission
- Potential benefits and potential approval and commercialization of VP-102 for the treatment of molluscum
- Company's plans with respect to planned clinical trials of VP-102 for common warts and VP-103 for plantar warts
- Torii’s potential exercise of their option under the Option Agreement and the potential terms and payments under the proposed license agreement.
Challenges Ahead
- Uncertainties inherent in the drug development process
- Uncertainties inherent in the regulatory approval process
- Verrica’s reliance on third parties over which it may not always have full control
Historical Earnings Impact
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