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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

Source: Corium

              
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  —    —    2    2  
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 
         

 

Monday, May 14, 2018 - 16:01