Corium International
Aug 3, 2017
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Corium Reports Recent Corporate Highlights and Financial Results for Third Quarter Fiscal 2017

MENLO PARK, Calif., Aug. 03, 2017 (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 third fiscal quarter and the nine months ended June 30, 2017, and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

Recent Corporate Developments

"Our third quarter was highlighted by the positive bioequivalence results we reported in May for our Corplex Donepezil transdermal product candidate," said Peter D. Staple, President and Chief Executive Officer of Corium.  "These data have enabled us to finalize the parameters of the pivotal BE study that we are initiating this quarter.  Our once-weekly patch formulation of donepezil has the potential to provide meaningful benefits to Alzheimer's disease patients and their caregivers, including both improved compliance and the ability to alleviate the most common gastrointestinal side effects associated with the oral drug."

Financial Results for the Quarter and Nine Months Ended June 30, 2017

Corium reported total revenues in the third quarter of fiscal 2017 of $8.1 million, compared with $10.6 million in the third quarter of fiscal 2016, and for the nine-month period ended June 30, 2017, reported total revenues of $22.4 million compared with $25.1 million in the same period of fiscal 2016.  Product revenues decreased for both the third quarter and the nine-month period ended June 30, 2017 compared to same periods of fiscal 2016, primarily as a result of a reduction in demand for both Fentanyl transdermal delivery system (TDS) and Clonidine TDS, which was partially offset by an increase in revenues from manufacture of Crest® Whitestrips for Procter & Gamble.  Contract research and development revenues were unchanged for the third quarter and increased for the nine-month period ended June 30, 2017 compared to the same periods of fiscal 2016.  The increase for the nine-month period was primarily the result of increased activities supporting Agile's NDA resubmission for Twirla.

Total research and development (R&D) expenses in the third quarter of fiscal 2017 were $12.1 million compared with $8.3 million in the third quarter of fiscal 2016, and for the nine-month period ended June 30, 2017, total R&D expenses were $30.5 million compared with $24.2 million in the same period of fiscal 2016.  These increases in total R&D expenses were driven by Corium's investment in its proprietary product programs, primarily the advancement of Corplex Donepezil into a pilot BE study beginning in late fiscal 2016 and expenses associated with the preparation for the upcoming pivotal BE trial. 

General and administrative (G&A) expenses in the third quarter of fiscal 2017 were $3.3 million compared with $3.1 million for the third quarter of fiscal 2016, and for the nine-month period ended June 30, 2017, total G&A expenses were $9.3 million compared with $9.1 million for the same period of fiscal 2016.

Corium reported a net loss for the third quarter of fiscal 2017 of $13.4 million, or $0.43 per share, compared with a net loss of $7.5 million, or $0.34 per share, in the third quarter of fiscal 2016.  For the nine-month period ended June 30, 2017, Corium reported a net loss of $34.9 million, or $1.30 per share, compared with a net loss of $27.4 million, or $1.23 per share, in the same period of fiscal 2016.  As of June 30, 2017, there were 35,739,278 shares of Corium common stock outstanding, reflecting the issuance of 6,440,000 shares in connection with a public offering completed in May 2017

Cash and cash equivalents as of June 30, 2017 were $66.6 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 third fiscal quarter and the nine months ended June 30, 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 58879021.  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, financial and operating performance, operating costs and expenses, product pipeline, clinical trial and regulatory timing and plans and associated resource requirements, 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 Quarterly Report on Form 10-Q for the quarter ended March 31, 2017, filed with the Securities and Exchange Commission (SEC) on May 12, 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 speaks 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.
Alzheimer's Association International Conference® and AAIC® are registered trademarks of Alzheimer's Disease and Related Disorders Association, Inc.

Source: Corium


CORIUM INTERNATIONAL, INC.
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)

(Unaudited)
 
  Three Months Ended
June 30,
 Nine Months Ended 
June 30,
 
  2017  2016  2017  2016  
Revenues:             
Product revenues $ 5,906  $ 7,264  $ 16,301  $ 18,930  
Contract research and development revenues   1,936    1,983    5,320    4,228  
Other revenues   267    1,359    801    1,947  
Total revenues   8,109    10,606    22,422    25,105  
Costs and operating expenses:             
Cost of product revenues   3,935    4,626    10,892    12,924  
Cost of contract research and development revenues   2,977    2,742    7,891    8,601  
Research and development expenses   9,122    5,516    22,650    15,566  
General and administrative expenses   3,284    3,116    9,288    9,106  
Amortization of intangible assets   159    168    514    489  
Loss on disposal of equipment   6     —    6    2  
Total costs and operating expenses   19,483    16,168    51,241    46,688  
Loss from operations   (11,374)   (5,562)   (28,819)   (21,583) 
Interest income   77     54    149    142  
Interest expense   (2,087)   (1,984)   (6,178)   (5,932) 
Loss before income taxes    (13,384)   (7,492)   (34,848)   (27,373) 
Income tax expense   —    —    2    3  
Net loss and comprehensive loss $ (13,384) $ (7,492) $ (34,850) $ (27,376) 
Net loss per share attributable to
common stockholders, basic and diluted
 $ (0.43) $ (0.34)  $ (1.30) $ (1.23) 
Weighted-average shares used in
computing net loss per share attributable
to common stockholders, basic and
diluted
   31,457,702    22,321,581    26,784,678    22,254,849  



CORIUM INTERNATIONAL, INC.
CONDENSED BALANCE SHEETS
(In thousands)
(Unaudited)
 
  As of
June 30,
  As of
September 30,
 
  2017  2016  
       
ASSETS       
Current assets:       
Cash and cash equivalents $ 66,563  $ 39,833  
Accounts receivable   4,577    4,336  
Unbilled accounts receivable   260    346  
Inventories   2,521    2,424  
Prepaid expenses and other current assets   1,133    1,341  
Total current assets   75,054    48,280   
Restricted cash   666    666  
Property and equipment, net   12,451    11,147  
Intangible assets, net   7,356    7,057  
TOTAL ASSETS $ 95,527  $ 67,150  
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:       
Accounts payable $ 5,404  $ 2,737  
Accrued expenses and other current liabilities   4,925    4,271  
Long-term debt, current portion   54    77  
Capital lease obligations, current portion   —    72  
Recall liability, current portion   160    460  
Deferred contract revenues, current portion   121    355  
Total current liabilities   10,664    7,972  
Long-term debt, net of current portion   52,040    50,966  
Recall liability, net of current portion    1,808    1,859  
Deferred contract revenues, net of current portion   3,500    3,500  
Total liabilities   68,012    64,297  
Commitments and contingencies       
Stockholders' equity:       
Common stock   36    22  
Additional paid-in capital   229,817    170,319  
Accumulated deficit    (202,338)   (167,488) 
Total stockholders' equity   27,515    2,853  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY           $ 95,527  $67,150  


Investor and Media Contact:

SMP Communications

Susan M. Pietropaolo

susan@smpcommunications.com

(201) 923-2049

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Source: Corium International, Inc.

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