- Initiated pilot bioequivalence study for Corplex Donepezil — Following the submission of an Investigational New Drug application in September, the company has completed enrollment and commenced dosing in a pilot bioequivalence study for Corplex Donepezil, a once-weekly transdermal therapeutic, compared to daily oral Aricept ® (donepezil hydrochloride) for Alzheimer's disease. The pilot study is a crossover study in healthy subjects, and will compare the steady-state plasma concentrations of the transdermal and oral products after several weeks of treatment. Based on the pilot study results, the Company will set the parameters of the pivotal study based on statistical bioequivalence (BE) criteria. The pivotal study is expected to start in the second half of 2017 and will have a duration of approximately 16 weeks, which would enable Corium to submit a 505(b)(2) New Drug Application (NDA) as early as mid-2018.
- Streamlined bioequivalence development paths for both of Corium's Alzheimer's programs — In April 2016, the FDA advised the company that, following demonstration of bioequivalence between Corplex Donepezil and daily oral Aricept in the company's pivotal BE study, additional clinical efficacy studies will not be required. The company also reported in August that it received similar written guidance from the FDA regarding its proposal for a pivotal study based on the demonstration of bioequivalence between Corplex Memantine and oral Namenda XR ® (memantine HCl) extended release capsules.
- Positive Corplex Donepezil data presented at Alzheimer's Association International Conference ® 2016 — The company presented full clinical trial results demonstrating sustained and controlled delivery of donepezil in the plasma concentrations of all subjects treated with Corium's once-weekly Corplex Donepezil patch, comparable to daily oral Aricept, which were indicative of bioequivalence.
- Positive Phase 1 clinical results drove advances in Alzheimer's programs — The company separately announced top-line results from Phase 1 studies of Corplex Donepezil and Corplex Memantine. These studies demonstrated positive pharmacokinetic data with sustained and controlled drug delivery, and provided a strong foundation for advancing clinical development of both product candidates.
- Partner Agile Therapeutics announces completion of subject visits for Phase 3 trial of Twirla ® once-weekly contraceptive patch — Agile has indicated that it expects to report top-line data in early January 2017. Corium provided all required clinical trial supplies and CMC support for the trial in which over 2,000 women participated. Preparations are currently underway for the manufacture of commercial quantities of Twirla in Corium's state-of-the-art facility.
- Partner Aequus Pharmaceuticals reported successful outcome of aripiprazole clinical study — Aequus completed a Phase 1 PK study of its once-weekly transdermal product candidate incorporating the active ingredient of Abilify ® in December 2015 and, pending approval by Health Canada, is preparing to initiate a multiple-dose follow-on study prior to the end of calendar 2016. Under its development agreement with Aequus, Corium has contributed to the formulation of the aripiprazole candidate, will have an undisclosed share in Aequus' revenues from the resulting product, and will be the exclusive manufacturer of the product.
- Completion of divestiture of Clonidine TDS from Teva to Mayne Pharma — Corium enabled the successful transfer of the Clonidine TDS product from Teva Pharmaceuticals to Mayne Pharma, in connection with Teva's divestiture of the product as a result of its acquisition of the Allergan generics business. Mayne Pharma acquired the rights to more products divested from Teva than any other company.
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,|
|Contract research and development revenues||1,192||2,923||5,420||12,721|
|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||)|
|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||)||$||(1.52||)|
|Weighted average shares used in computing net loss per share attributable to common stockholders, basic and diluted||22,365,247||20,594,810||22,282,599||18,709,292|
|CORIUM INTERNATIONAL, INC.|
|Condensed Balance Sheets|
|As of September 30,|
|Cash and cash equivalents||$||39,833||$||72,218|
|Unbilled accounts receivable||346||812|
|Prepaid expenses and other current assets||1,341||1,367|
|Total current assets||48,280||81,760|
|Property and equipment, net||11,147||11,593|
|Intangible assets, net||7,057||6,854|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||4,271||4,091|
|Long-term debt, current portion||77||57|
|Capital lease obligations, current portion||72||820|
|Recall liability, current portion||460||760|
|Deferred contract revenues, current portion||355||134|
|Total current liabilities||7,972||9,814|
|Long-term debt, net of current portion||50,966||49,270|
|Capital lease obligations, net of current portion||—||72|
|Recall liability, net of current portion||1,859||2,229|
|Deferred contract revenues, net of current portion||3,500||3,500|
|Additional paid-in capital||170,319||166,085|
|Total stockholders' equity||2,853||35,322|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||67,150||$||100,207|
Investor and Media Contact:SMP CommunicationsSusan M. Pietropaolosusan@smpcommunications.com(201) 923-2049