Corium International
Nov 21, 2016
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Corium Reports Fourth Quarter and Fiscal Year 2016 Financial Results and Recent Corporate Highlights

MENLO PARK, Calif., Nov. 21, 2016 (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 fourth fiscal quarter and the year ended September 30, 2016, and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

"During the 2016 fiscal year we made outstanding progress in moving our two lead Alzheimer's programs forward," said Peter D. Staple, President and Chief Executive Officer of Corium.  "Corplex™ Donepezil and Corplex™ Memantine are novel once-weekly transdermal product candidates that deliver the two most widely used treatments for patients with Alzheimer's disease, and would be the first transdermal dosage forms of these drugs.  Our two Alzheimer's programs provide a powerful foundation for a CNS-focused proprietary pipeline.  At the beginning of the fiscal year, we had just initiated our first-in-human clinical trials of both of these product candidates, and since then we have generated positive human clinical data.  With those results, we have gained clear regulatory guidance from the FDA on a streamlined bioequivalence-based development path that applies to both products.  The first of those bioequivalence studies has just begun, and we look forward to submitting Corium's first NDA in 2018."

Fourth Quarter and Fiscal Year 2016 Highlights

Financial Results for the Quarter and Fiscal Year Ended September 30, 2016

Corium reported total revenues in the fourth quarter of fiscal 2016 of $7.9 million, compared with $9.3 million in the fourth quarter of fiscal 2015, and for the fiscal year ended September 30, 2016, reported total revenues of $33.0 million, compared with $40.9 million in fiscal 2015.  For fiscal 2016, the decrease in total revenues resulted primarily from a decline in contract research and development revenues, as well as a decline in product revenues versus fiscal 2015.  The decrease in contract research and development revenues is primarily the result of several programs advancing into later stages of clinical development, when there are fewer revenue-generating development activities until preparations begin for approval and commercial launch, along with the discontinuation of two development projects in fiscal 2015.  The $1.2 million decline in product revenues for fiscal 2016 compared to fiscal 2015 is primarily the result of fewer Fentanyl TDS units ordered and shipped, which was partially offset by an increase in revenues from Crest® Whitestrips.
   
Total research and development (R&D) expenses in the fourth quarter of fiscal 2016 were $8.2 million, compared with $8.6 million in the fourth quarter of fiscal 2015, and for the fiscal year ended September 30, 2016, total R&D expenses were $32.4 million, compared with $32.5 million in fiscal 2015.  For fiscal 2016, R&D expenses associated with Corium's investment in its proprietary product programs increased, including the advancement of Corium's two programs for Alzheimer's disease through Phase 1 clinical trials.  This increase in R&D spending was offset by a lower level of resources required for contract research and development programs, corresponding to the lower level of revenues from contract research and development.

General and administrative (G&A) expenses in the fourth quarter of fiscal 2016 were $2.5 million, compared with $3.0 million in the fourth quarter of fiscal 2015, and for the fiscal year ended September 30, 2016, G&A expenses were $11.6 million, compared with $11.2 million in fiscal 2015.  The increase in G&A for the year was primarily attributable to an increase in stock-based compensation expense and higher personnel costs.

Corium reported a net loss for the fourth quarter of fiscal 2016 of $9.3 million, or $0.42 per share, compared with a net loss of $8.6 million, or $0.42 per share, in the fourth quarter of fiscal 2015.  For the fiscal year ended September 30, 2016, Corium reported a net loss of $36.7 million, or $1.65 per share, compared with a net loss of $28.5 million, or $1.52 per share, in fiscal 2015.  As of September 30, 2016, there were 22,391,631 shares of Corium common stock outstanding.

Cash and cash equivalents as of September 30, 2016 were $39.8 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 fourth fiscal quarter and year ended September 30, 2016.  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 17537774. 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, Endo Pharmaceuticals 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.  The company's late-stage pipeline includes a contraceptive patch co-developed with Agile Therapeutics that has recently completed all subject visits for its Phase 3 trial, and additional transdermal products that are being developed with other partners.  For further information, please visit www.coriumgroup.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 August 12, 2016, filed with the Securities and Exchange Commission on June 30, 2016, and other reports as filed from time to time with the Securities and Exchange Commission.  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.
Namenda XR® is a registered trademark of Merz Pharma GmbH & Co. KGaA.
Crest® Whitestrips is a registered trademark of The Procter & Gamble Company.
Abilify® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.

  
CORIUM INTERNATIONAL, INC. 
Condensed Statements of Operations and Comprehensive Loss 
(unaudited, in thousands, except share and per share data) 
  
  Three Months Ended 
September 30,
 Years
Ended September 30,
 
  2016  2015 2016   2015  
Revenues:           
Product revenues$6,432  $6,047  $25,362  $26,514  
Contract research and development revenues 1,192   2,923  5,420   12,721  
Other revenues 294   296  2,241   1,686  
Total revenues 7,918   9,266  33,023    40,921  
Costs and operating expenses:                 
Cost of product revenues 4,422   4,239  17,346   17,608  
Cost of contract research and development revenues 2,073   3,772  10,674   16,064  
Research and development expenses 6,121    4,784  21,687   16,454  
General and administrative expenses 2,460   2,993  11,566   11,185  
Amortization of intangible assets 170   158  659   622  
Loss on disposal and sale and leaseback of equipment 13   10  15    12  
Total costs and operating expenses 15,259   15,956  61,947   61,945  
Loss from operations (7,341)  (6,690) (28,924)  (21,024) 
Interest income 29   12  171   23  
Interest expense (2,015)  (1,956) (7,947)  (7,446) 
Loss before income taxes (9,327)  (8,634) (36,700)  (28,447) 
Income tax expense    1  3   3  
Net loss and comprehensive loss$(9,327) $(8,635) $(36,703) $(28,450) 
Net loss per share attributable to common stockholders, basic and diluted$(0.42) $(0.42) $(1.65) $(1.52) 
Weighted average shares used in computing net loss per share attributable to common stockholders, basic and diluted 22,365,247   20,594,810   22,282,599   18,709,292  
                  


CORIUM INTERNATIONAL, INC. 
Condensed Balance Sheets 
(In thousands) 
(Unaudited) 
  
  As of September 30,  
   2016 2015 
        
ASSETS       
Current assets:       
Cash and cash equivalents $39,833  $72,218  
Accounts receivable  4,336   4,461  
Unbilled accounts receivable  346   812  
Inventories, net   2,424   2,902  
Prepaid expenses and other current assets  1,341   1,367  
Total current assets  48,280   81,760  
Restricted cash  666      
Property and equipment, net  11,147   11,593  
Intangible assets, net  7,057   6,854  
TOTAL ASSETS $67,150  $100,207  
LIABILITIES AND STOCKHOLDERS' EQUITY       
Current liabilities:       
Accounts payable $2,737  $3,952  
Accrued expenses and other current liabilities  4,271   4,091   
Long-term debt, current portion  77   57  
Capital lease obligations, current portion  72   820  
Recall liability, current portion  460   760  
Deferred contract revenues, current portion  355   134  
Total current liabilities  7,972   9,814  
Long-term debt, net of current portion  50,966   49,270  
Capital lease obligations, net of current portion     72  
Recall liability, net of current portion  1,859   2,229  
Deferred contract revenues, net of current portion  3,500   3,500  
Total liabilities  64,297   64,885  
Stockholders' equity:       
Common stock  22   22  
Additional paid-in capital  170,319   166,085  
Accumulated deficit  (167,488)  (130,785) 
Total stockholders' equity  2,853   35,322  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $67,150  $100,207  
          

 

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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