– Reports YCANTH® revenue, net of $4.9M for second quarter of 2024 along with the expansion of YCANTH’s distribution footprint to include Cencora, Inc. as a specialty distributor –
– Announces positive preliminary topline results of Phase 2 clinical study of VP-315 for the treatment of patients with basal cell carcinoma –
– Continues to progress preparation for global Phase 3 Common Warts trial with initiation expected in 1H 2025 –
– Conference Call Scheduled for Today at 8:30 am ET –
WEST CHESTER, Pa., Aug. 14, 2024 (GLOBE NEWSWIRE) — Verrica Pharmaceuticals Inc. (“Verrica”) (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, today announced financial results for the second quarter ended June 30, 2024.
“Verrica continued to make steady progress during the second quarter of 2024, highlighted by the receipt of a permanent J-Code for YCANTH that went into effect on April 1,” said Ted White, Verrica’s President and Chief Executive Officer. “We are already beginning to see the effects of the permanent J-Code on increasing demand for YCANTH, as product coverage and reimbursement decisions for our Medicaid patient population become increasingly streamlined. We also have made notable progress in removing unapproved, compounded cantharidin distributed by Dormer Laboratories from the U.S. market following our litigation settlement with Dormer. Based on these two positive developments, coupled with our growing insurance coverage and distribution capabilities, we expect YCANTH prescription growth to continue quarter over quarter in the second half of 2024.
“Our late-stage clinical pipeline is also making meaningful progress. This morning, we announced exciting new data from our Phase 2 study evaluating our novel oncolytic peptide, VP-315, for the treatment of basal cell carcinoma. Based on these positive safety and efficacy data, we believe VP-315 has the potential to become a first-line therapy for the treatment of basal cell carcinoma, and we look forward to sharing more detailed results at a KOL event in the near-future. In addition, we recently amended our agreement with Torii Pharmaceutical Inc. Ltd., which we believe will enable us to further advance YCANTH into Phase 3 testing for the potential treatment of common warts. Common warts represent the single largest unmet need in all of dermatology, and we believe YCANTH could establish a new standard of care for this pervasive condition with no FDA-approved therapies.”
Conference Call and Webcast Information
The Company will host a conference call today, Wednesday, August 14, 2024, at 8:30 AM, Eastern Time, to discuss its second quarter 2024 financial results and provide a business update. To participate in the conference call, please utilize the following information:
Domestic Dial-In Number: Toll-Free: 1-800-579-2543
International Dial-In Number: 1-785-424-1789
Conference ID: VERRICA
The call will also be broadcast live over the Web and can be accessed on Verrica Pharmaceuticals’ website: www.verrica.com or directly at
https://viavid.webcasts.com/starthere.jsp?ei=1678543&tp_key=8db298d3d3
The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.
Business Highlights and Recent Developments
YCANTH® (VP-102)
VP-315
Financial Results
Second Quarter 2024 Financial Results
Year-to-Date June 2024 Financial Results
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 expense and non-cash interest expense that are required by GAAP. Verrica excludes non-cash stock-based compensation expense from these non-GAAP measures to facilitate comparison to peer companies who also provide similar non-GAAP disclosures and because it reflects how management internally manages the business. In addition, Verrica excludes non-cash interest expense from these non-GAAP measures to facilitate an understanding of the effects of the debt service obligations on the Company’s liquidity and comparisons to peer group companies who also provide similar non-GAAP disclosures and because it is reflective of how management internally manages the business. 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.
VERRICA PHARMACEUTICALS INC. Statements of Operations (in thousands except share and per share data) (unaudited) |
||||||||
Three Months Ended June 30, | ||||||||
2024 | 2023 | |||||||
Product revenue, net | $ | 4,892 | $ | – | ||||
Collaboration revenue | 285 | 182 | ||||||
Total revenue | 5,177 | 182 | ||||||
Operating expenses: | ||||||||
Selling, general and admin | 16,522 | 5,937 | ||||||
Research and development | 3,319 | 5,725 | ||||||
Cost of product revenue | 360 | – | ||||||
Cost of collaboration revenue | 182 | 136 | ||||||
Total operating expenses | 20,383 | 11,798 | ||||||
Loss from operations | (15,206 | ) | (11,616 | ) | ||||
Interest income | 393 | 626 | ||||||
Interest expense | (2,368 | ) | – | |||||
Other expense | (5 | ) | – | |||||
Net loss | $ | (17,186 | ) | $ | (10,990 | ) | ||
Net loss per share, basic and diluted | $ | (0.37 | ) | $ | (0.24 | ) | ||
Weighted-average common shares outstanding, basic and diluted | 46,502,274 | 45,916,867 | ||||||
VERRICA PHARMACEUTICALS INC. Statements of Operations (in thousands except share and per share data) (unaudited) |
||||||||
Six Months Ended June 30, | ||||||||
2024 | 2023 | |||||||
Product revenue, net | $ | 8,124 | $ | – | ||||
Collaboration revenue | 879 | 219 | ||||||
Total revenue | 9,003 | 219 | ||||||
Operating expenses: | ||||||||
Selling, general and admin | 32,861 | 10,256 | ||||||
Research and development | 8,267 | 8,464 | ||||||
Cost of product revenue | 906 | – | ||||||
Cost of collaboration revenue | 774 | 204 | ||||||
Total operating expenses | 42,808 | 18,924 | ||||||
Loss from operations | (33,805 | ) | (18,705 | ) | ||||
Interest income | 991 | 1,126 | ||||||
Interest expense | (4,687 | ) | – | |||||
Other expense | (16 | ) | – | |||||
Net loss | $ | (37,517 | ) | $ | (17,579 | ) | ||
Net loss per share, basic and diluted | $ | (0.81 | ) | $ | (0.40 | ) | ||
Weighted-average common shares outstanding, basic and diluted | 46,492,971 | 44,478,116 | ||||||
VERRICA PHARMACEUTICALS INC. Selected Balance Sheet Data (in thousands) (unaudited) |
|||||||
June 30, 2024 |
December 31, 2023 |
||||||
Cash and cash equivalents | $ | 31,930 | $ | 69,547 | |||
Prepaid assets and other expenses | 15,388 | 7,983 | |||||
Total current assets | 47,318 | 77,530 | |||||
PP&E, lease right of use asset, other | 4,692 | 4,067 | |||||
Total assets | $ | 52,010 | $ | 81,597 | |||
Total liabilities | $ | 65,310 | $ | 61,834 | |||
Total stockholders’ (deficit) equity | (13,300 | ) | 19,763 | ||||
Total liabilities and stockholders’ (deficit) equity | $ | 52,010 | $ | 81,597 |
VERRICA PHARMACEUTICAS INC. Reconciliation of Non-GAAP Financial Measures (unaudited) (in thousands except per share data) |
|||||||||||
Three Months Ended June 30, 2024 | |||||||||||
Loss from operations |
Net loss | Net loss per share |
|||||||||
GAAP | $ | (15,206 | ) | $ | (17,186 | ) | $ | (0.37 | ) | ||
Non-GAAP Adjustments: | |||||||||||
Stock-based compensation – Selling, general and admin (a) |
1,715 | 1,715 | |||||||||
Stock-based compensation – Research and development (a) |
513 | 513 | |||||||||
Non-cash interest expense (b) | – | 516 | |||||||||
Adjusted | $ | (12,978 | ) | $ | (14,442 | ) | $ | (0.31 | ) | ||
Three Months Ended June 30, 2023 | |||||||||||
Loss from operations |
Net loss | Net loss per share |
|||||||||
GAAP | $ | (11,616 | ) | $ | (10,990 | ) | $ | (0.24 | ) | ||
Non-GAAP Adjustments: | |||||||||||
Stock-based compensation – Selling, general & admin (a) |
950 | 950 | |||||||||
Stock-based compensation – Research & development (a) |
594 | 594 | |||||||||
Adjusted | $ | (10,072 | ) | $ | (9,446 | ) | $ | (0.21 | ) | ||
Six Months Ended June 30, 2024 | |||||||||||
Loss from operations |
Net loss | Net loss per share |
|||||||||
GAAP | $ | (33,805 | ) | $ | (37,517 | ) | $ | (0.81 | ) | ||
Non-GAAP Adjustments: | |||||||||||
Stock-based compensation – Selling, general and admin (a) |
3,337 | 3,337 | |||||||||
Stock-based compensation – Research and development (a) |
963 | 963 | |||||||||
Non-cash interest expense (b) | – | 999 | |||||||||
Adjusted | $ | (29,505 | ) | $ | (32,219 | ) | $ | (0.69 | ) | ||
Six Months Ended June 30, 2023 | |||||||||||
Loss from operations |
Net loss | Net loss per share |
|||||||||
GAAP | $ | (18,705 | ) | $ | (17,579 | ) | $ | (0.40 | ) | ||
Non-GAAP Adjustments: | |||||||||||
Stock-based compensation – Selling, general & admin (a) |
1,785 | 1,785 | |||||||||
Stock-based compensation – Research & development (a) |
853 | 853 | |||||||||
Adjusted | $ | (16,067 | ) | $ | (14,941 | ) | $ | (0.34 | ) |
(a) | The effects of non-cash stock-based compensation are excluded because of varying available valuation methodologies and subjective assumptions. Verrica believes this is a useful measure for investors because such exclusion facilitates comparison to peer companies who also provide similar non-GAAP disclosures and is reflective of how management internally manages the business. | |
(b) | The effects of non-cash interest charges are excluded because Verrica believes such exclusion facilitates an understanding of the effects of the debt service obligations on the Company’s liquidity and comparisons to peer group companies and is reflective of how management internally manages the business. |
About Verrica Pharmaceuticals Inc.
Verrica is a dermatology therapeutics company developing medications for skin diseases requiring medical interventions. On July 21, 2023, YCANTH® (cantharidin), became the first treatment approved by the FDA to treat adult and pediatric patients two years of age and older with molluscum contagiosum, a highly contagious viral skin infection affecting approximately 6 million people in the United States, primarily children. YCANTH (VP-102) is also in development to treat common warts and external genital warts, two of the largest remaining unmet needs in medical dermatology. Verrica is also developing VP-103, its second cantharidin-based product candidate, for the treatment of plantar warts. Verrica has also entered a worldwide license agreement with Lytix Biopharma AS to develop and commercialize VP-315 (formerly LTX-315 and VP-LTX-315) for non-melanoma skin cancers including basal cell carcinoma and squamous cell carcinoma. For more information, visit www.verrica.com.
Forward-Looking Statements
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” and similar expressions, and are based on Verrica’s current beliefs and expectations. These forward-looking statements include expectations regarding the continuing commercial launch of YCANTH™, quarter over quarter YCANTH prescription growth in the second half of 2024, the potential for VP-315 to become a first-line therapy for the treatment of basal cell carcinoma, future financial performance, the clinical development of Verrica’s product candidates, including the timing of reporting data from clinical trials, the potential benefits of YCANTH and Verrica’s product candidates and Verrica’s ability to fund its operations into the first quarter of 2025. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the drug development process and the regulatory approval process, Verrica’s reliance on third parties over which it may not always have full control and uncertainties that are described in Verrica’s Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Report on Form 10-Q for the quarter ended June 30, 2024 and other filings Verrica makes with the U.S. Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and are based on information available to Verrica as of the date of this release, and Verrica assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.
FOR MORE INFORMATION, PLEASE CONTACT:
Investors:
Terry Kohler
Chief Financial Officer
tkohler@verrica.com
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
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