SEC Comment Letter for Verrica Pharmaceuticals Inc. (VRCA) (CIK 0001660334) (VRCA) — Apr 26, 2018
Verrica Pharmaceuticals Inc. (VRCA) (CIK 0001660334)
Date: April 26, 2018 · CIK: 0001660334 · Accession: 0000000000-18-012970
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April 26, 2018
Ted White
Chief Executive Officer and President
Verrica Pharmaceuticals Inc.
200 Garrett Street, Suite S
Charlottesville, VA 22902
Re:Verrica Pharmaceuticals Inc.
Draft Registration Statement on Form S-1
Submitted March 30, 2018
CIK No. 0001660334
Dear Mr. White:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted on March 30, 2018
Prospectus Summary
Overview, page 1
1.We note that entities affiliated with PBM VP Holdings, LLC beneficially own 58.4% of
your shares, three of your five directors are affiliated with PBM Capital Group, LLC and
PBM Capital Group, LLC provides scientific and technical, accounting, operations and
back office support services to you. Please provide disclosure in the prospectus summary
about your relationship with PBM Capital.
FirstName LastNameTed White
Comapany NameVerrica Pharmaceuticals Inc.
June 16, 2017 Page 2
FirstName LastNameTed White
Verrica Pharmaceuticals Inc.
April 26, 2018
Page 2
2.We note your disclosure that that VP-102 has the potential for its active pharmaceutical
ingredient to be characterized as a new chemical entity, or NCE, with the regulatory
exclusivity associated with that designation. To place your disclosure in appropriate
context, please expand your disclosure to describe the length and scope of regulatory
exclusivity that VP-102's active pharmaceutical ingredient will qualify for upon NCE
designation, and to disclose that the composition of matter for the chemical structure of
cantharidin is not eligible for patent protection, as referenced on page 39.
VP-103 for the Treatment of Plantar Warts, page 3
3.We note your disclosure that you expect to be able to substantially leverage your
experience with VP-102 to develop VP-103 for the treatment of plantar warts. You also
indicate in your pipeline development chart that you have completed Phase 1 development
of VP-103. Please revise your disclosure to clarify whether you expect to be able to rely
on the Phase 1 data collected to date for VP-103 such that if your IND is approved, you
will be able to commence Phase 2 clinical trials. If this is not the case, please revise the
arrow in your pipeline development chart accordingly.
Risks Associated with our Business, page 4
4.Please expand the risk factor in the seventh bullet point to highlight the difficulty of
successfully establishing coverage and adequate reimbursement for your product
candidates as a result of the higher prices associated with drugs administered under the
supervision of a physician and the risk that separate coverage or reimbursement may not
be available for your product candidates. Please also revise the ninth bullet point in this
section to specify that you do not own any issued patents.
Implications of Being an Emerging Growth Company, page 5
5.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
Use of Proceeds, page 62
6.It appears from your disclosure that the proceeds from the offering will not be sufficient to
fund development of your product candidates other than VP-102 for the treatment of
molloscum through regulatory approval and commercialization. Please indicate how far
the proceeds from the offering will allow you to proceed with the continued development
of each of your product candidates. Please also disclose the sources of other funds needed
to reach regulatory approval and commercialization for each product candidate. Refer to
Instruction 3 to Item 504 of Regulation S-K.
FirstName LastNameTed White
Comapany NameVerrica Pharmaceuticals Inc.
June 16, 2017 Page 3
FirstName LastNameTed White
Verrica Pharmaceuticals Inc.
April 26, 2018
Page 3
Selected Financial Data, page 68
7.Please revise your pro forma net loss per share calculations so that only the latest fiscal
year is presented, here and elsewhere, as applicable.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies
Stock-Based Compensation, page 75
8.Once you have an estimated offering price or range, please explain to us the reasons for
any differences between the recent valuations of your common stock leading up to the
initial public offer and the estimated offering price. This information will help facilitate
our review of your accounting for equity issuances including stock compensation and
beneficial conversion features.
Business
Phase 2 Clinical Trial -- Pilot Trial, page 88
9.We note your disclosure on page 89 that you believe the results of your Pilot Trial support
your conclusion that your proprietary cantharidin formulation had comparable evidence of
efficacy and safety in the trial to that of historically used compounded formulations of
cantharidin when both are applied using a wooden part of a cotton-tipped swab. Please
revise your disclosure to provide data regarding the efficacy and safety of historically used
compounded formulations of cantharidin to support this statement.
Manufacturing, page 91
10.We note your disclosure on page 32 that you currently rely on a supplier based in the
People's Republic of China to supply naturally-sourced cantharidin and that there are no
assurances you would be able to enter into a similar contractual arrangement for naturally-
sourced cantharidin. Please expand your disclosure on page 32 and in this section to
provide the name of the supplier and the material terms of your supply agreement. In
addition, please file the agreement as an exhibit to your registration statement or explain
why you are not substantially dependent on the agreement. Refer to Item 101(c)(1)(iii)
and Item 601(b)(10) of Regulation S-K.
Intellectual Property, page 93
11.Please expand your disclosure to include the foreign jurisdictions for which you have
made patent applications.
Report of Independent Public Accounting Firm, page F-2
12.Please have your auditors revise their report to include your shareholders as an addressee,
as required by PCAOB Auditing Standard 3101.
FirstName LastNameTed White
Comapany NameVerrica Pharmaceuticals Inc.
June 16, 2017 Page 4
FirstName LastName
Ted White
Verrica Pharmaceuticals Inc.
April 26, 2018
Page 4
General
13.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Bonnie Baynes at (202) 551-4924 or Angela Connell at (202) 551-
3426 if you have questions regarding comments on the financial statements and related
matters. Please contact Christine Westbrook at (202) 551-5019 or Irene Paik at (202) 551-
6553 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Divakar Gupta, Esq.