cori_8K_20180514_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): May 14, 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 May 14, 2018, Corium International, Inc. (the “Company”) issued a press release to announce its financial results for its second fiscal quarter ended March 31, 2018.  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 May 14, 2018. 

 

2


 

INDEX TO EXHIBITS

 

 

 

 

Exhibit
Number

    

Description of Exhibit

 

 

 

99.1

 

Press release dated May 14, 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: May 14, 2018

 

By:

/s/ Robert Breuil

 

 

 

Robert Breuil

 

 

 

Chief Financial Officer

 

 

 


cori_Ex99_1

Exhibit 99.1

 

Corium Reports Second Quarter Fiscal 2018 Financial Results and Corporate Highlights

 

MENLO PARK, Calif., May 14,  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 second fiscal quarter and the six months ended March 31, 2018 and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

 

Corporate Highlights

 

·

Corplex™ Donepezil NDA to be submitted using pilot bioequivalence data —  Based on positive feedback from the U.S. Food and Drug Administration (FDA),  Corium announced that it will submit the data from its successful pilot bioequivalence (BE) study for the planned New Drug Application (NDA) for Corplex Donepezil.  Corium is now in the process of conducting the ancillary clinical studies required for the NDA.  These ancillary studies,  which include standard skin tolerability,  alternative patch application site and heat effect studies, are well underway and progressing as planned.  As previously announced, Corium is targeting submission of a Section 505(b)(2) NDA in the first quarter of calendar 2019.

 

·

Notice of allowance for key U.S. Corplex Donepezil patent —  The United States Patent and Trademark Office issued a notice of allowance for a  foundational patent related to Corplex Donepezil.  This patent provides coverage of the drug product and its unique design features, including composition elements that achieve a  sustained, controlled and effective delivery of donepezil across the skin for the 7-day wear period.  This patent will be eligible for listing in the FDA Orange Book and should provide patent protection to at least July 2037.  It is the first to be allowed in a series of pending Corium patent applications related to Corplex Donepezil.

 

·

Completed $120 million convertible debt offering In March, Corium completed the sale of $120 million in aggregate principal amount of 5.00% Convertible Senior Notes due 2025 in a private offering to qualified institutional buyers.  Corium used approximately $56 million of the proceeds to repay in full its outstanding borrowings under its term loan agreement with CRG, and will use the remainder for working capital and other general corporate purposes.

 

"The quarter was highlighted by our decision to use our successful pilot bioequivalence data comparing Corplex Donepezil and Aricept®  as the basis for our NDA submission.  This decision was driven by favorable feedback from the FDA following the agency’s review of the full pharmacokinetic report for that study and our consultations with external experts,” said Peter D. Staple, President and Chief Executive Officer of Corium.  “The notice of allowance for our new composition of matter patent on this


 

product validates the innovative approach that we have taken in developing Corplex Donepezil and further strengthens the long-term commercial value of the product.”

 

Financial Results for the Quarter Ended March 31, 2018

 

Corium reported total revenues of $10.1 million in the second quarter of fiscal 2018, compared with $7.3  million in the same period of fiscal 2017, and reported total revenues of $19.4 million for the six-month period ended March 31, 2018, compared with $14.3 million in the same period in fiscal 2017.  Product revenues increased for both the second quarter of fiscal 2018 and for the six-month period ended March 31, 2018,  compared to the same periods in fiscal 2017, primarily as a result of an increase in revenues from Mayne Pharma for Clonidine TDS and an increase in revenues from Procter & Gamble for Crest® Whitestrips.  Contract research and development revenues increased for both the second quarter and the six-month period ended March 31, 2018,  compared to the same periods in fiscal 2017,  primarily as a result of increased activities supporting Agile’s development program for Twirla®, increased development activity for Mayne on multiple product candidates, and increased development for Procter & Gamble related to the ongoing acquisition of a third production line.

 

Total research and development (R&D) expenses were $15.3 million in the second quarter of fiscal 2018, compared with $10.3 million in the same period of fiscal 2017, and were $29.1 million for the six-month period ended March 31, 2018, compared with $18.4 million in the same period in 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 a second BE trial, along with the ancillary clinical trials required to support the NDA filing for this product.

 

General and administrative (G&A) expenses were $4.1 million in the second quarter of fiscal 2018, compared with $3.0 million for the same period of fiscal 2017, and were $7.4 million for the six-month period ended March 31, 2018, compared with $6.0 million in the same period in fiscal 2017.  The increase was primarily driven by higher one-time legal and outside services costs,  as well as higher stock-based compensation costs.

 

Corium reported a net loss of $18.0 million for the second quarter in fiscal 2018, or $0.50 per share, compared with a net loss of $11.0 million, or $0.42 per share, in the same period of fiscal 2017.  For the six-month period ended March 31, 2018, the net loss was  $31.3 million, or $0.87 per share, compared with a net loss of $21.5 million, or $0.88 per share, for the same period in fiscal 2017.  As of March 31, 2018, there were 36,139,058 shares of Corium common stock outstanding.

 

Cash and cash equivalents as of March 31, 2018 were $94.2 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 second fiscal quarter and the six months ended March 31, 2018.  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 7690614.  The 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,  use of proceeds from the recent convertible debt offering, product pipeline, intellectual property rights and portfolio,  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-Q for the quarter ended December 31, 2017, filed with the Securities and Exchange Commission (SEC) on February 12, 2018, 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
March 31, 

 

Six Months Ended
March 31, 

 

    

2018 

    

2017 

    

2018 

    

2017 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

Product revenues

 

$

6,690 

 

$

4,657 

 

$

12,611 

 

$

10,395 

Contract research and development revenues

 

 

3,130 

 

 

2,421 

 

 

6,284 

 

 

3,384 

Other revenues

 

 

240 

 

 

267 

 

 

480 

 

 

534 

Total revenues

 

 

10,060 

 

 

7,345 

 

 

19,375 

 

 

14,313 

Costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

 

4,015 

 

 

2,876 

 

 

7,299 

 

 

6,957 

Cost of contract research and development revenues

 

 

3,294 

 

 

2,794 

 

 

6,899 

 

 

4,914 

Research and development expenses

 

 

11,968 

 

 

7,530 

 

 

22,206 

 

 

13,528 

General and administrative expenses

 

 

4,103 

 

 

2,999 

 

 

7,403 

 

 

6,004 

Amortization of intangible assets

 

 

181 

 

 

178 

 

 

358 

 

 

355 

Total costs and operating expenses

 

 

23,561 

 

 

16,377 

 

 

44,165 

 

 

31,758 

Loss from operations

 

 

(13,501)

 

 

(9,032)

 

 

(24,790)

 

 

(17,445)

Interest income

 

 

163 

 

 

44 

 

 

285 

 

 

72 

Interest expense

 

 

(2,410)

 

 

(2,049)

 

 

(4,533)

 

 

(4,091)

Loss on extinguishment of long-term debt

 

 

(2,258)

 

 

— 

 

 

(2,258)

 

 

— 

Loss before income taxes

 

 

(18,006)

 

 

(11,037)

 

 

(31,296)

 

 

(21,464)

Income tax expense

 

 

— 

 

 

— 

 

 

 

 

Net loss and comprehensive loss

 

$

(18,006)

 

$

(11,037)

 

$

(31,298)

 

$

(21,466)

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

 

$

(0.50)

 

$

(0.42)

 

$

(0.87)

 

$

(0.88)

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

 

 

36,147,306 

 

 

26,487,493 

 

 

36,109,749 

 

 

24,448,166 

 

 


 

CORIUM INTERNATIONAL, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

As of
March 31,

 

As of
September 30,

 

    

2018

    

2017

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

94,221 

 

$

57,466 

Accounts receivable

 

 

4,165 

 

 

4,641 

Unbilled accounts receivable

 

 

274 

 

 

169 

Inventories

 

 

1,975 

 

 

2,300 

Prepaid expenses and other current assets

 

 

415 

 

 

982 

Total current assets

 

 

101,050 

 

 

65,558 

Property and equipment, net

 

 

14,190 

 

 

12,176 

Intangible assets, net

 

 

7,235 

 

 

7,117 

TOTAL ASSETS

 

$

122,475 

 

$

84,851 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

6,308 

 

$

3,978 

Accrued expenses and other current liabilities

 

 

5,764 

 

 

6,411 

Long-term debt, current portion

 

 

48 

 

 

13,172 

Recall liability, current portion

 

 

187 

 

 

114 

Deferred contract revenues, current portion

 

 

157 

 

 

626 

Total current liabilities

 

 

12,464 

 

 

24,301 

Convertible notes, net

 

 

68,159 

 

 

— 

Long-term debt, net of current portion

 

 

350 

 

 

39,027 

Recall liability, net of current portion

 

 

1,684 

 

 

1,811 

Deferred contract revenues, net of current portion

 

 

3,500 

 

 

3,500 

Total liabilities

 

 

86,157 

 

 

68,639 

Commitments and contingencies

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

Common stock

 

 

36 

 

 

36 

Additional paid-in capital

 

 

282,861 

 

 

231,457 

Accumulated deficit

 

 

(246,579)

 

 

(215,281)

Total stockholders’ equity

 

 

36,318 

 

 

16,212 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

122,475 

 

$

84,851