cori_8K_20180207_ER

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549


FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

 

Date of report (date of earliest event reported): February 8, 2018


Corium International, Inc.

(Exact name of registrant as specified in its charter)


 

 

 

 

 

 

 

Delaware

    

001-36375

   

38-3230774

(State or other jurisdiction of
incorporation or organization)

 

(Commission File Number)

 

(I.R.S. Employer
Identification Number)

 

 

235 Constitution Drive,
Menlo Park, California

 

94025

(Address of Principal Executive Offices)

 

(Zip Code)

 

(650) 298-8255
(Registrant’s telephone number, including area code)

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 


 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

 

☐    Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐    Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐    Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐    Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

 

 

 


 

Item 2.02. Results of Operations and Financial Condition.

 

On February 8, 2018, Corium International, Inc. (the “Company”) issued a press release to announce its financial results for its first fiscal quarter ended December 31, 2017.  A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

 

The information furnished with this report, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

 

 

 

Exhibit 
Number

    

Description

 

 

 

99.1

 

Press release dated February 8, 2018. 

 

2


 

INDEX TO EXHIBITS

 

 

 

 

Exhibit
Number

    

Description of Exhibit

 

 

 

99.1

 

Press release dated February 8, 2018.

 

 


 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

 

 

    

CORIUM INTERNATIONAL, INC.

 

 

 

Date: February 8, 2018

 

By:

/s/ Robert Breuil

 

 

 

Robert Breuil

 

 

 

Chief Financial Officer

 

 

 


cori_Ex99_1

Exhibit 99.1

 

Corium Reports First Quarter Fiscal 2018 Financial Results and Corporate Highlights

 

MENLO PARK, Calif., February 8,  2018 (GLOBE NEWSWIRE) – Corium International, Inc. (Nasdaq: CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited financial results for the first fiscal quarter ended December 31, 2017, and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

 

Corporate Highlights

 

   Dosing commenced in final treatment period of Corplex™ Donepezil pivotal trial —  In January, Corium commenced the second and final treatment period of its Corplex Donepezil pivotal bioequivalence (BE) study, which compares the company’s once-weekly transdermal patch to daily oral Aricept®  (donepezil hydrochloride).  The pivotal BE study design is a streamlined version of the successful pilot BE trial, and is a single center, randomized, multiple dose, two-way crossover study in healthy volunteers, conducted at the same clinical site as the pilot BE trial.  The dosing in the second treatment period is scheduled to be completed in February; top-line results are expected in the second quarter of calendar 2018.

 

   Ancillary studies underway in preparation for NDA — Corium is conducting ancillary studies that are required in the New Drug Application (NDA) data package for Corplex Donepezil, including standard skin tolerability and alternative patch application site studies, which are underway, and a heat effects study planned to commence in February.  Corium is targeting submission of a Section 505(b)(2) NDA in the fourth quarter of calendar 2018.

 

   Corium joined NASDAQ Biotechnology Index — In December, Corium was added to the NASDAQ Biotechnology Index (NBI) as part of the NBI’s annual re-ranking.  Companies in the NBI must meet certain requirements, including minimum market capitalization and average daily trading volume, among other criteria.  The NASDAQ Biotechnology Index forms the basis for a number of Exchange Traded Funds (ETFs), including the iShares NASDAQ Biotechnology ETF.

 

"During the quarter, we continued to build on the momentum created in fiscal 2017,” said Peter D. Staple, President and Chief Executive Officer of Corium.  “Our proprietary Corplex Donepezil program has moved forward at a rapid pace; we generated our first human data in 2016 and are actively working towards filing an NDA by the end of this year.  In parallel, we have been conducting formulation and feasibility work on preclinical candidates that represent substantial market opportunities,  most of which could also benefit from a similar bioequivalence development path.  In our partner-based business, we are working with Agile Therapeutics to address questions from the FDA relating to Twirla®,  Agile’s once-weekly contraceptive patch, which we believe represents a significant upside opportunity.  We are also in the process of expanding manufacturing capacity for Procter & Gamble’s Crest® Whitestrips, as global demand for these products increases.”

 


 

 

Financial Results for the Quarter Ended December 31, 2017

 

Corium reported total revenues in the first quarter of fiscal 2018 of $9.3  million, compared with $7.0  million in the same period of fiscal 2017.  Product revenues increased for the first quarter of fiscal 2018 compared to same period of fiscal 2017, primarily as a result of an increase in revenues from Procter & Gamble for Crest® Whitestrips and an increase in revenues from Mayne Pharma for our Fentanyl transdermal delivery system (TDS), partially offset by a reduction in demand from Mayne Pharma for Clonidine TDS.  Contract research and development revenues increased for the first quarter of fiscal 2018 compared to the same period of fiscal 2017,  primarily resulting from increased activities supporting Agile’s development program for Twirla.

 

Total research and development (R&D) expenses in the first quarter of fiscal 2018 were $13.8 million compared with $8.1  million in the same period of fiscal 2017.  The increase in total R&D expenses was driven by Corium’s investment in its proprietary product programs, primarily the advancement of Corplex Donepezil into its pivotal BE trial.

 

General and administrative (G&A) expenses in the first quarter of fiscal 2018 were $3.3  million compared with $3.0 million for the same period of fiscal 2017.  The increase was primarily driven by higher stock-based compensation costs.

 

Corium reported a net loss for the first quarter of fiscal 2018 of $13.3 million, or $0.37 per share, compared with a net loss of $10.4 million, or $0.46 per share, in the same period of fiscal 2017.  As of December 31, 2017, there were 36,117,913 shares of Corium common stock outstanding, and as of December 31,  2016, there were 22,557,450 shares of Corium common stock outstanding, so comparisons of per share losses between periods may not be useful to investors.

 

Cash and cash equivalents as of December 31, 2017 were $45.2 million.

 

Conference Call and Webcast Details

 

Corium will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results for the first fiscal quarter ended December 31,  2017.  Investors and analysts can access the call toll-free by dialing (844) 831-3024 (United States) or +1 (315) 625-6887 (international).  The conference ID# is 7046249The conference call will also be available via a live audio webcast which may be accessed here, or by visiting the Investors section of Corium's website at http://ir.coriumgroup.com/events.cfm.  The webcast will be archived on the Corium website for two weeks following the presentation.

 

 


 

About Corium

 

Corium International, Inc. is a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty pharmaceutical products that leverage the company's broad experience with advanced transdermal and transmucosal delivery systems.  Corium has multiple proprietary programs in preclinical and clinical development, focusing primarily on the treatment of neurological disorders, with lead programs in Alzheimer's disease.  Corium has developed and is the sole commercial manufacturer of seven prescription drug and consumer products with partners Mayne Pharma and Procter & Gamble.  The company has two proprietary transdermal platforms: Corplex™ for small molecules and MicroCor®, a biodegradable microstructure technology for small molecules and biologics, including vaccines, peptides and proteins.  In addition to its proprietary Alzheimer's program, the company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics and additional transdermal products that are being developed with other partners.  For further information, please visit www.coriumintl.com.

 

Forward-Looking Statements

 

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, including statements regarding our business strategy, market and growth opportunities, financial and operating performance,  product pipeline, clinical trial and regulatory timing and plans, regulatory pathways for our development programs, the achievement of clinical and commercial milestones, and the advancement of our technologies as well as our proprietary, co-developed and partnered products and product candidates.  Forward-looking statements are based on management's current expectations and projections and are subject to risks and uncertainties, which may cause Corium's actual results to differ materially from the statements contained herein.  Further information on potential risk factors that could affect Corium's business and its results are detailed in Corium's Annual Report on Form 10-K for the year ended September 30, 2017, filed with the Securities and Exchange Commission (SEC) on December 29, 2017, and other reports as filed from time to time with the SEC.  Undue reliance should not be placed on forward-looking statements, especially guidance on future financial or operating performance, which speak only as of the date they are made.  Corium undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date they were made or to reflect the occurrence of unanticipated events.

 

Corplex™ and MicroCor® are trademarks of Corium International, Inc.

Twirla® is a registered trademark of Agile Therapeutics, Inc.

Aricept® is a registered trademark of Eisai R&D Management Co, Ltd.

Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.

 

###

 

Investor and Media Contact:

SMP Communications

Susan M. Pietropaolo

susan@smpcommunications.com

(201) 923-2049

 


 

CORIUM INTERNATIONAL, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

 

Three Months Ended
December 31,

 

    

2017

    

2016

Revenues:

 

 

 

 

 

 

Product revenues

 

$

5,921 

 

$

5,738 

Contract research and development revenues

 

 

3,154 

 

 

963 

Other revenues

 

 

240 

 

 

267 

Total revenues

 

 

9,315 

 

 

6,968 

Costs and operating expenses:

 

 

 

 

 

 

Cost of product revenues

 

 

3,284 

 

 

4,081 

Cost of contract research and development revenues

 

 

3,605 

 

 

2,120 

Research and development expenses

 

 

10,238 

 

 

5,998 

General and administrative expenses

 

 

3,300 

 

 

3,005 

Amortization of intangible assets

 

 

177 

 

 

177 

Total costs and operating expenses

 

 

20,604 

 

 

15,381 

Loss from operations

 

 

(11,289)

 

 

(8,413)

Interest income

 

 

122 

 

 

28 

Interest expense

 

 

(2,123)

 

 

(2,042)

Loss before income taxes

 

 

(13,290)

 

 

(10,427)

Income tax expense

 

 

 

 

Net loss and comprehensive loss

 

$

(13,292)

 

$

(10,429)

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.37)

 

$

(0.46)

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

36,073,008 

 

 

22,453,172 

 


 

CORIUM INTERNATIONAL, INC.

CONDENSED BALANCE SHEETS

(In thousands)

(Unaudited)

 

 

As of
December 31,

 

As of
September 30,

 

    

2017

    

2017

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

45,230 

 

$

57,466 

Accounts receivable

 

 

4,856 

 

 

4,641 

Unbilled accounts receivable

 

 

407 

 

 

169 

Inventories

 

 

2,526 

 

 

2,300 

Prepaid expenses and other current assets

 

 

1,263 

 

 

982 

Total current assets

 

 

54,282 

 

 

65,558 

Property and equipment, net

 

 

12,922 

 

 

12,176 

Intangible assets, net

 

 

7,149 

 

 

7,117 

TOTAL ASSETS

 

$

74,353 

 

$

84,851 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

7,712 

 

$

3,978 

Accrued expenses and other current liabilities

 

 

4,132 

 

 

6,411 

Long-term debt, current portion

 

 

26,298 

 

 

13,172 

Recall liability, current portion

 

 

221 

 

 

114 

Deferred contract revenues, current portion

 

 

390 

 

 

626 

Total current liabilities

 

 

38,753 

 

 

24,301 

Long-term debt, net of current portion

 

 

25,994 

 

 

39,027 

Recall liability, net of current portion

 

 

1,698 

 

 

1,811 

Deferred contract revenues, net of current portion

 

 

3,500 

 

 

3,500 

Total liabilities

 

 

69,945 

 

 

68,639 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

36 

 

 

36 

Additional paid-in capital

 

 

232,945 

 

 

231,457 

Accumulated deficit

 

 

(228,573)

 

 

(215,281)

Total stockholders’ equity

 

 

4,408 

 

 

16,212 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

74,353 

 

$

84,851