Exhibit 99.1

 

Corium Reports Fourth Quarter and Fiscal Year 2017 Financial Results and Corporate Highlights

 

MENLO PARK, Calif., November 16, 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 fourth fiscal quarter and the year ended September 30, 2017, and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

 

Corporate Highlights

 

·

Successful pilot bioequivalence study in Alzheimer’s program  In May, Corium reported results for its successful three-way crossover pilot bioequivalence (BE) trial for Corplex™ Donepezil, a once-weekly transdermal therapeutic for Alzheimer's disease, comparing steady-state pharmacokinetics (PK) to daily oral Aricept® (donepezil hydrochloride) after five weeks of treatment.  Donepezil is the most commonly prescribed medication for Alzheimer’s patients.  The study results demonstrated that Corplex Donepezil met the primary statistical criteria for bioequivalence to oral Aricept.  Corplex Donepezil was well tolerated with favorable adhesion, skin safety and gastrointestinal side effect profiles.  

 

·

Positive FDA feedback on Corplex Donepezil —  In August, Corium held an end of Phase 2 meeting with the U.S. Food and Drug Administration (FDA) in which the company reviewed the results from the pilot BE trial of Corplex Donepezil.  The FDA confirmed the choice of PK parameters and statistical testing approaches used in Corium’s BE study.  The agency also confirmed Corium’s design of planned supportive studies and other requirements for product registration.

 

·

Corplex Donepezil pivotal trial underway Corium has initiated dosing of Corplex Donepezil in its pivotal bioequivalence study.  The design of the pivotal BE study is similar to the pilot study, and is a  single center, randomized, multiple dose, two-way crossover study in healthy volunteers, conducted at the same clinical site as the successful pilot BE study.  The first treatment period will be complete in December.  Top-line results are expected in the first half of calendar 2018 and Corium is targeting submission of a Section 505(b)(2) New Drug Application (NDA) in the fourth quarter of calendar 2018. 

 

·

Strengthened balance sheet; addition to Russell Indexes —  During the year, Corium completed two financings, raising gross proceeds in excess of $60 million.  In June 2017, the Company was added to the Russell 3000® and Russell 2000® as part of Russell Investments' annual reconstitution of its U.S. indexes, based on total market capitalization as of the end of May 2017. 

 

·

PDUFA date for partner Agile Therapeutics Twirla® once-weekly contraceptive  In July 2017, the FDA accepted resubmission of Agile’s New Drug Application (NDA) for Twirla, an investigational, once-weekly low-dose


The following information was filed by Corium International, Inc. (CORI) on Thursday, November 16, 2017 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

View differences made from one year to another to evaluate Corium International, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ)
Sample 10-K Year-over-Year (YoY) Comparison

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were  removed  ,   added    and   changed   by Corium International, Inc..

Continue

Never Miss A New SEC Filing Again


Real-Time SEC Filing Notifications
Screenshot taken from Gmail for a new 10-K Annual Report
Last10K.com Member Feature

Receive an e-mail as soon as a company files an Annual Report, Quarterly Report or has new 8-K corporate news.

Continue

We Highlighted This SEC Filing For You


SEC Filing Sentiment Analysis - Bullish, Bearish, Neutral
Screenshot taken from Wynn's 2018 10-K Annual Report
Last10K.com Member Feature

Read positive and negative remarks made by management in their entirety without having to find them in a 10-K/Q.

Continue

Widen Your SEC Filing Reading Experience


Increased Reading Area for SEC Filings
Screenshot taken from Adobe Inc.'s 10-Q Quarterly Report
Last10K.com Member Feature

Remove data columns and navigations in order to see much more filing content and tables in one view

Continue

Uncover Actionable Information Inside SEC Filings


SEC Filing Disclosures
Screenshot taken from Lumber Liquidators 10-K Annual Report
Last10K.com Member Feature

Read both hidden opportunities and early signs of potential problems without having to find them in a 10-K/Q

Continue

Adobe PDF, Microsoft Word and Excel Downloads


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshots of actual 10-K and 10-Q SEC Filings in PDF, Word and Excel formats
Last10K.com Member Feature

Export Annual and Quarterly Reports to Adobe PDF, Microsoft Word and Excel for offline viewing, annotations and analysis

Continue

FREE Financial Statements


Download Annual and Quarterly Reports as PDF, Word and Excel Documents
Screenshot of actual balance sheet from company 10-K Annual Report
Last10K.com Member Feature

Get one-click access to balance sheets, income, operations and cash flow statements without having to find them in Annual and Quarterly Reports

Continue for FREE

Intrinsic Value Calculator


Intrinsic Value Calculator
Screenshot of intrinsic value for AT&T (2019)
Last10K.com Member Feature

Our Intrinsic Value calculator estimates what an entire company is worth using up to 10 years of financial ratios to determine if a stock is overvalued or not

Continue

Financial Stability Report


Financial Stability Report
Screenshot of financial stability report for Coco-Cola (2019)
Last10K.com Member Feature

Our Financial Stability reports uses up to 10 years of financial ratios to determine the health of a company's EPS, Dividends, Book Value, Return on Equity, Current Ratio and Debt-to-Equity

Continue

Get a Better Picture of a Company's Performance


Financial Ratios
Available Financial Ratios
Last10K.com Member Feature

See how over 70 Growth, Profitability and Financial Ratios perform over 10 Years

Continue

Log in with your credentials

or    

Forgot your details?

Create Account