Corium International
May 11, 2017
PDF

Corium Reports Second Quarter Fiscal 2017 Financial Results and Recent Corporate Highlights

MENLO PARK, Calif., May 11, 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 second fiscal quarter and the six months ended March 31, 2017, and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

Recent Corporate Developments

"The second quarter was an especially productive one for Corium, culminating in the recent clinical success of our proprietary Corplex Donepezil product candidate," said Peter D. Staple, President and Chief Executive Officer of Corium.  "With that data now in hand, we have increased confidence in our ability to bring this important new therapeutic option to Alzheimer's patients and their caregivers.  In addition, we have strengthened a core component of our partner-focused development and manufacturing business by renewing our strategic oral care relationship with Procter & Gamble for a five-year term, and we also expanded the breadth of our partnership with Mayne Pharma to include additional generic transdermal products."

Financial Results for the Quarter and Six Months Ended March 31, 2017

Corium reported total revenues in the second quarter of fiscal 2017 of $7.3 million, compared with $7.0 million in the second quarter of fiscal 2016, and for the six-month period ended March 31, 2017 reported total revenues of $14.3 million compared with $14.5 million in the same period of fiscal 2016.  Contract research and development revenues increased for both the second quarter and the six-month period ended March 31, 2017 compared to the same periods in fiscal 2016, primarily as the result of increased activities supporting Agile's NDA for Twirla.  Product revenues decreased for both the second quarter and the six-month period ended March 31, 2017 compared to same periods in fiscal 2016, primarily as a result of a reduction in demand for both Fentanyl TDS and Clonidine TDS, which were partially offset by an increase in revenues from Crest Whitestrips. 
   
Total research and development (R&D) expenses in the second quarter of fiscal 2017 were $10.3 million compared with $8.4 million in the second quarter of fiscal 2016, and for the six-month period ended March 31, 2017 total R&D expenses were $18.4 million compared with $15.9 million in the same period of fiscal 2016.  The increase in R&D expenses was driven by Corium's investment in its proprietary product programs, primarily the advancement of Corplex Donepezil into a pilot bioequivalence study beginning in late fiscal 2016.  This increase in proprietary R&D spending was partially offset by a lower level of resources required for contract research and development programs.

General and administrative (G&A) expenses in the second quarter of fiscal 2017 were $3.0 million compared with the same amount for the second quarter of fiscal 2016, and for the six-month period ended March 31, 2017, total G&A expenses were $6.0 million compared with the same amount for the same period of fiscal 2016.  

Corium reported a net loss for the second quarter of fiscal 2017 of $11.0 million, or $0.42 per share, compared with a net loss of $10.5 million, or $0.47 per share, in the second quarter of fiscal 2016.  For the six-month period ended March 31, 2017, Corium reported a net loss of $21.5 million, or $0.88 per share, compared with a net loss of $19.9 million, or $0.89 per share, in the same period of fiscal 2016.  As of March 31, 2017, there were 29,232,292 shares of Corium common stock outstanding, reflecting the issuance of 6,666,667 shares in connection with a public offering completed in February 2017

Cash and cash equivalents as of March 31, 2017 were $40.6 million.

Conference Call and Webcast Details

Corium will host a conference call today at 8:30 a.m. ET (5:30 a.m. PT) to discuss the financial results for the second fiscal quarter ended March 31, 2017 and the preliminary results of the Corplex Donepezil pilot bioequivalence study.  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 20268962.  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 where an accompanying slide presentation will be available.  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.  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.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 December 31, 2016, filed with the Securities and Exchange Commission (SEC) on February 14, 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.



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,
 
  2017  2016  2017  2016  
Revenues:             
Product revenues $ 4,657  $ 5,694  $ 10,395  $ 11,666  
Contract research and development revenues   2,421    975    3,384    2,245  
Other revenues   267    293    534    588  
Total revenues    7,345    6,962    14,313    14,499  
Costs and operating expenses:             
Cost of product revenues   2,876    4,000    6,957    8,298  
Cost of contract research and development revenues   2,794    2,803    4,914    5,859  
Research and development expenses   7,530    5,593    13,528    10,050  
General and administrative expenses   2,999    2,973    6,004    5,990  
Amortization of intangible assets   178    162    355    321  
Loss on disposal of equipment   —    2    —    2  
Total costs and operating expenses   16,377    15,533     31,758    30,520  
Loss from operations   (9,032)   (8,571)   (17,445)   (16,021) 
Interest income   44    58    72    88  
Interest expense   (2,049)   (1,971)   (4,091)   (3,948) 
Loss before income taxes   (11,037)   (10,484)   (21,464)   (19,881) 
Income tax expense   —    —    2    3  
Net loss and comprehensive loss  $ (11,037) $ (10,484) $ (21,466) $ (19,884) 
Net loss per share attributable to common stockholders, basic and diluted $ (0.42) $ (0.47) $ (0.88)  $ (0.89) 
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted   26,487,493    22,255,365    24,448,166    22,221,666  



CORIUM INTERNATIONAL, INC.
CONDENSED BALANCE SHEETS
(In thousands)
(Unaudited)
        
  As of
March 31,
  As of
September 30,
 
  2017  2016  
       
ASSETS       
Current assets:       
Cash and cash equivalents $ 40,574  $ 39,833  
Accounts receivable   3,440    4,336  
Unbilled accounts receivable   183    346  
Inventories   2,668    2,424  
Prepaid expenses and other current assets   797    1,341  
Total current assets   47,662    48,280  
Restricted cash   666    666   
Property and equipment, net   11,966    11,147  
Intangible assets, net   7,221    7,057  
TOTAL ASSETS $ 67,515  $ 67,150  
LIABILITIES AND STOCKHOLDERS' EQUITY        
Current liabilities:       
Accounts payable $ 3,674  $ 2,737  
Accrued expenses and other current liabilities   4,365    4,271  
Long-term debt, current portion   62    77  
Capital lease obligations, current portion   —    72  
Recall liability, current portion   330     460  
Deferred contract revenues, current portion   241    355  
Total current liabilities   8,672    7,972  
Long-term debt, net of current portion   51,485    50,966  
Recall liability, net of current portion   1,717    1,859  
Deferred contract revenues, net of current portion   3,500    3,500  
Total liabilities   65,374    64,297  
Commitments and contingencies       
Stockholders' equity:       
Common stock   29    22  
Additional paid-in capital   191,066    170,319  
Accumulated deficit   (188,954)   (167,488) 
Total stockholders' equity   2,141    2,853  
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 67,515  $67,150  


Source: Corium

 

Investor and Media Contact:

SMP Communications

Susan M. Pietropaolo

susan@smpcommunications.com

(201) 923-2049

Primary Logo

Source: Corium International, Inc.

News Provided by Acquire Media