Full Press Release Details
Verrica Pharmaceuticals Reports Second Quarter 2023 Financial Results
In July, FDA approved YCANTH for the treatment of molluscum, a highly
contagious viral skin infection affecting approximately 6 million people annually in the United States, primarily children
YCANTH launch expected by September 2023
Expanding Part 2 enrollment of ongoing Phase 2 trial of VP-315 in basal cell carcinoma to
accelerate clinical development
Secured $125 million debt facility to support launch of YCANTHTM
Cash runway extended into the first quarter of 2025
WEST CHESTER, PA Aug 8, 2023 (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, 2023.
The U.S Food and Drug Administration (FDA) approval of YCANTH for the treatment of molluscum
marks the most important achievement in our company s history said Ted White, Verrica s President and Chief Executive Officer. With no other FDA-approved therapies available prior to
YCANTH , molluscum represents one of the largest and most underserved patient populations in all of dermatology, and we could not be prouder to launch this product that can positively impact
so many patients. Following the approval of YCANTH , we had the opportunity to secure significant, non-dilutive capital to ensure that we have ample
resources to support the YCANTH product launch. With our cash runway extended into the first quarter of 2025, and our commercial organization fully operational, we are ready to make YCANTH available to the millions of patients who will benefit from this therapy.
continue to make significant progress in advancing our novel oncolytic peptide, VP-315, which is currently being evaluated in a Phase 2 trial in patients with basal cell carcinoma. We recently made the
decision to expand patient enrollment in Part 2 of the trial, which we believe will provide enough patient data so that we can bypass Part 3 of the trial and advance VP-315 directly into a later-stage,
potentially registration-enabling trial.
Business Highlights and Recent Developments
Second Quarter 2023 Financial
Year-to-Date June 2023 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 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 YCANTH (VP-102)
YCANTH (VP-102) is a proprietary drug-device
combination product that contains a GMP-controlled formulation of cantharidin delivered via a single-use applicator that allows for precise topical
dosing and targeted administration for the treatment of molluscum. YCANTH is the only product approved by the FDA to treat molluscum a common, highly contagious skin disease
that affects an estimated six million people in the United States, primarily children.
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.
VP-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 was initially 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 VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma and was recently amended to two-parts by expanding Part 2. The study is expected to
enroll approximately 80 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion.
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
commercial launch of YCANTH , including the timing thereof, Verrica s achievement of revenue milestones under the debt facility, the
availability of future financing from the debt facility with OrbiMed, Verrica s ability to fund ongoing operations without additional equity financing if the additional $75 million is borrowed, Verrica s ability to fund its operations
into the first quarter of 2025 and the timing of clinical trial completion for VP-315. 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, 2022 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.
PHARMACEUTICALS INC.
Statements of Operations
(in thousands, except share and per share data)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| Collaboration revenue | $ | 182 | $ | 214 | $ | 219 | $ | 645 | ||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | 5,725 | 3,943 | 8,464 | 6,388 | ||||||||||||
| General and administrative | 5,937 | 5,173 | 10,256 | 10,291 | ||||||||||||
| Cost of collaboration revenue | 136 | 219 | 204 | 497 | ||||||||||||
| Total operating expenses | 11,798 | 9,335 | 18,924 | 17,176 | ||||||||||||
| Loss from operations | (11,616 | ) | (9,121 | ) | (18,705 | ) | (16,531 | ) | ||||||||
| Interest income | 626 | 20 | 1,126 | 42 | ||||||||||||
| Interest and other expense | (1,067 | ) | (2,149 | ) | ||||||||||||
| Net loss | $ | (10,990 | ) | $ | (10,168 | ) | $ | (17,579 | ) | $ | (18,638 | ) | ||||
| Net loss per share, basic and diluted | $ | (0.24 | ) | $ | (0.37 | ) | $ | (0.40 | ) | $ | (0.68 | ) | ||||
| Weighted average common shares outstanding, basic and diluted | 45,916,867 | 27,519,053 | 44,478,116 | 27,519,053 |
VERRICA PHARMACEUTICALS INC.
Selected Balance Sheet Data
| June 30, 2023 | December 31, 2022 | |||||||
| Cash and cash equivalents | $ | 55,140 | $ | 34,273 | ||||
| Collaboration revenue billed & unbilled receivables | 173 | 487 | ||||||
| Prepaid expenses, and other assets | 1,464 | 4,355 | ||||||
| Total current assets | 56,777 | 39,115 | ||||||
| PP&E, lease right of use asset, other | 5,424 | 5,606 | ||||||
| Total assets | $ | 62,201 | $ | 44,721 | ||||
| Total liabilities | $ | 6,801 | $ | 4,688 | ||||
| Total stockholders equity | 55,400 | 40,033 | ||||||
| Total | $ | 62,201 | $ | 44,721 |
VERRICA PHARMACEUTICALS INC.
Reconciliation of Non-GAAP Financial Measures (unaudited)
(in thousands except per share data)
| 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 | ) |
| Three Months Ended June 30, 2022 | ||||||||||||
| Loss from Operations | Net loss | Net loss per share | ||||||||||
| GAAP | $ | (9,121 | ) | $ | (10,168 | ) | $ | (0.37 | ) | |||
| Non-GAAP Adjustments: | ||||||||||||
| Stock-based compensation Selling, General & Admin (a) | 745 | 745 | ||||||||||
| Stock-based compensation Research & Development (a) | 340 | 340 | ||||||||||
| Non-cash interest expense (b) | 302 | |||||||||||
| Adjusted | $ | (8,036 | ) | $ | (8,781 | ) | $ | (0.32 | ) |
| Six Months Ended June 30, 2023 | ||||||||||||
| Loss from Operations | Net loss | Net loss per share | ||||||||||
| GAAP | $ | (18,706 | ) | $ | (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 | ) | |||
| Six Months Ended June 30, 2022 | ||||||||||||
| Loss from Operations | Net loss | Net loss per share | ||||||||||
| GAAP | $ | (16,531 | ) | $ | (18,638 | ) | $ | (0.68 | ) | |||
| Non-GAAP Adjustments: | ||||||||||||
| Stock-based compensation Selling, General & Admin (a) | 1,644 | 1,644 | ||||||||||
| Stock-based compensation Research & Development (a) | 757 | 757 | ||||||||||
| Non-cash interest expense (b) | 634 | |||||||||||
| Adjusted | $ | (14,130 | ) | $ | (15,603 | ) | $ | (0.57 | ) |
FOR MORE INFORMATION, PLEASE CONTACT:
Chief Financial Officer