Corium Reports Recent Corporate Highlights and Financial Results for Third Quarter Fiscal 2017
Recent Corporate Developments
- Initiating pivotal trial of Corplex™ Donepezil for Alzheimer's — Recruitment and screening of subjects for Corium's pivotal bioequivalence (BE) study of Corplex Donepezil is underway, with dosing expected to begin before the end of
September 2017. The pivotal BE trial is a two-way crossover study, and will be conducted in healthy volunteers at the same clinical site as the recently-completed pilot BE study. Topline results are expected in the first calendar quarter of 2018, and Corium is targeting submission of a Section 505(b)(2) New Drug Application (NDA) in the second half of calendar 2018.
- Positive pilot bioequivalence results presented at Alzheimer's
Association International Conference® 2017 — Corium recently presented the results from the company's pilot BE study of Corplex Donepezil in a poster presentation at the Alzheimer's Association International Conference2017 (AAIC®) in London. Data from the pilot BE study demonstrated that Corium's Corplex Donepezil transdermal product candidate successfully met the primary pharmacokinetic criteria for bioequivalence to oral Aricept® (donepezil hydrochloride), with a favorable tolerability and safety profile.
- Successful follow-on financing strengthens balance sheet — In
May 2017, Corium completed an underwritten public offering of common stock, with gross proceeds of $40.3 million, including proceeds from the full exercise of the underwriters' option to purchase additional shares.
- Partner Agile Therapeutics resubmits NDA for Twirla® once-weekly contraceptive — In
June 2017, Agile Therapeutics resubmitted its NDA for Twirla, its investigational low-dose combined hormonal contraceptive patch, and the FDAhas notified Agile of its acceptance of the resubmitted NDA for review. Agile reported that the Prescription Drug User Fee Act (PDUFA) goal date for this NDA is December 26, 2017. Corium is the exclusive manufacturer and supplier of Twirla.
"Our third quarter was highlighted by the positive bioequivalence results we reported in May for our Corplex Donepezil transdermal product candidate," said
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
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
General and administrative (G&A) expenses in the third quarter of fiscal 2017 were
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
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 (
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
Corplex™ and MicroCor® are trademarks of
Twirla® is a registered trademark of Agile Therapeutics, Inc.
Aricept® is a registered trademark of
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)
|Three Months Ended
||Nine Months Ended
|Contract research and development revenues||1,936||1,983||5,320||4,228|
|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||)|
|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||)||$||(27,376||)|
|Net loss per share attributable to
common stockholders, basic and diluted
|Weighted-average shares used in
computing net loss per share attributable
to common stockholders, basic and
|CORIUM INTERNATIONAL, INC.
CONDENSED BALANCE SHEETS
|| As of
|Cash and cash equivalents||$||66,563||$||39,833|
|Unbilled accounts receivable||260||346|
|Prepaid expenses and other current assets||1,133||1,341|
|Total current assets||75,054||48,280|
|Property and equipment, net||12,451||11,147|
|Intangible assets, net||7,356||7,057|
|LIABILITIES AND STOCKHOLDERS' EQUITY|
|Accrued expenses and other current liabilities||4,925||4,271|
|Long-term debt, current portion||54||77|
|Capital lease obligations, current portion||—||72|
|Recall liability, current portion||160||460|
|Deferred contract revenues, current portion||121||355|
|Total current liabilities||10,664||7,972|
|Long-term debt, net of current portion||52,040||50,966|
|Recall liability, net of current portion||1,808||1,859|
|Deferred contract revenues, net of current portion||3,500||3,500|
|Commitments and contingencies|
|Additional paid-in capital||229,817||170,319|
|Total stockholders' equity||27,515||2,853|
|TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY||$||95,527||$||67,150|
Investor and Media Contact:
SMP Communications Susan M. Pietropaolosusan@smpcommunications.com (201) 923-2049
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