8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of report (date of earliest event reported): May 11, 2017

Corium International, Inc.

(Exact name of registrant as specified in its charter)

Delaware	001-36375	38-3230774
(State or other jurisdiction of incorporation or organization)	(Commission File Number)	(I.R.S. Employer Identification Number)

235 Constitution Drive, Menlo Park, California	94025
(Address of Principal Executive Offices)	(Zip Code)

(650) 298-8255
(Registrant’s telephone number, including area code)

Not Applicable
(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2 below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☒ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☒

Item 7.01.Regulation FD.

On May 11, 2017, Corium International, Inc. (the “Company”) issued a press release announcing preliminary positive results from its recently completed pilot bioequivalence study for Corplex Donepezil, a once-weekly transdermal therapeutic for Alzheimer’s disease.  A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.  The Company will discuss these results further on its second fiscal quarter earnings conference call scheduled at 8:30 a.m. Eastern time on May 11, 2017.  A copy of the related presentation materials that the Company intends to provide to investors on the conference call are furnished as Exhibit 99.2 to this report and are incorporated herein by reference.  These presentation materials also are posted under the “Investors” section on the Company’s website at www.coriumgroup.com. The Company does not undertake to update these presentation materials.

The information furnished with this report, including Exhibit 99.1 and Exhibit 99.2, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any other filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number	Description
99.1	Press release dated May 11, 2017.
99.2	Presentation materials for conference call on May 11, 2017.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	CORIUM INTERNATIONAL, INC.
Date: May 11, 2017	By:	/s/ Peter D. Staple
		Peter D. Staple
		Chief Executive Officer

INDEX TO EXHIBITS

Exhibit Number	Description of Exhibit
99.1	Press release dated May 11, 2017.
99.2	Presentation materials for conference call on May 11, 2017.

EX-99.1

Exhibit 99.1

Corium Reports Positive Preliminary Results in Alzheimer’s Clinical Study

Once-Weekly Corplex™ Donepezil Patch Achieves Bioequivalence to Aricept®

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 reported preliminary positive results from its recently completed pilot bioequivalence (BE) study demonstrating that its Corplex™ Donepezil product candidate successfully met the criteria for bioequivalence to oral Aricept® (donepezil hydrochloride) using primary pharmacokinetic (PK) endpoints previously established with the US Food and Drug Administration (FDA).  Corplex Donepezil is a proprietary once-weekly transdermal patch for delivery of the most commonly prescribed treatment for all stages of Alzheimer’s disease.      

The pilot BE study was  a six-month, three-period, randomized crossover study comparing the steady-state pharmacokinetic profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size.  Corium reported that the steady-state PK profiles of the transdermal dosage forms exhibited a close similarity with the oral dosage form PK results, and that the smaller of the two patches met the statistical criteria for bioequivalence at steady-state, based on the primary PK parameters of Cmax (maximum plasma concentration) and AUC (area under the curve).

Both Corplex transdermal treatments were well tolerated, with favorable adhesion, skin safety and gastrointestinal side effect profiles after application of over 500 patches in the course of the study.  For example, the incidence of nausea in subjects on the smaller patch was more than four-fold lower than the incidence of nausea with oral Aricept.  

Corium is pursuing the bioequivalence-based development and regulatory pathway for Corplex Donepezil after receiving positive written feedback on this approach from the FDA in April 2016.  The pilot study was designed with the objective of enabling the company to finalize patch size and other key parameters to successfully demonstrate bioequivalence in a pivotal BE study.  Corium is planning to start its pivotal BE study later this year and remains on track to file a Section 505(b)(2) New Drug Application (NDA) for the product candidate in 2018.  The pivotal study will be a  simpler, two-way crossover design compared to the three-way crossover pilot study.    

“We are extremely pleased that our Corplex Donepezil patches performed as well as we had projected, and that one of the tested patches actually met the regulatory bioequivalence criteria at the pilot stage.  Based on these results, we can now move forward knowing that we have a product candidate that can meet the bioequivalence-based registration criteria,” said Parminder “Bobby” Singh, Ph.D., Chief Technology Officer and Vice President of Research and Development of Corium.  “With this exciting clinical progress, we  are finalizing the scale up and related activities to support the start of our pivotal study this fall, with the objective of filing our NDA in 2018.”

“I am encouraged by the rapid clinical development of Corium’s once-weekly transdermal donepezil product,” added Pierre N. Tariot, M.D., a leading authority on Alzheimer’s disease research who is Director of the Banner Alzheimer’s Institute in Phoenix, Arizona, co-director of the NIH-funded Alzheimer’s Prevention Initiative, and a clinical advisor to Corium.  “Given the inherent challenges we face treating persons with Alzheimer’s, as well as limitations of currently available medications, I am hopeful that the transdermal approach can afford improved compliance and potential clinical benefits that could truly matter to both our patients and their families.”

Study Design

The pilot BE study was performed at a single trial site and enrolled 60 healthy male and female volunteers aged 20 to 78, with over 80% of the subjects over the age of 40.

The study, conducted over a period of six months, was a three-period, randomized crossover study comparing the steady-state PK profiles of once-daily oral Aricept with two Corplex Donepezil transdermal patches that differed only in size.   

During each period, study participants received one week of 5mg per day of donepezil, followed by 4 weeks of 10mg per day of donepezil.  PK measurements were evaluated during the fifth week of each treatment period, when plasma concentrations had achieved steady state levels.  PK samples for subjects receiving the transdermal treatments were taken on a daily basis throughout this fifth week; subjects receiving oral Aricept had PK samples taken on the last day of the fifth week.  There was a three-week washout period between treatment periods.

The primary objective was to enable the company to finalize key parameters for the pivotal BE study, including determination of the final patch size and the required number of subjects.  The secondary objectives were assessment of safety and tolerability.

About Alzheimer's Disease and Donepezil

Alzheimer's disease is a progressive brain disorder in which the brain cells degenerate and die, causing a steady decline in memory and mental function.  An estimated 5.5 million Americans are living with Alzheimer's disease in 2017; by 2025, this number is expected to exceed 7 million.  Alzheimer's disease is the most common cause of dementia among older adults.  Dementia ranges in severity from mild, when it is just beginning to affect a person's functioning, to moderate, and severe, when the person must depend on others for the basic activities of day-to-day life.

Donepezil (the active ingredient in Aricept) is the most widely prescribed medication in a class of Alzheimer's drugs known as cholinesterase inhibitors, and is approved for the treatment of mild, moderate and severe disease.  Donepezil is currently only available in tablet or orally disintegrating tablet form, each administered once daily, presenting compliance challenges for family members and caregivers who cannot rely on patients to consistently take their daily tablets, and is known to cause gastrointestinal side effects, including nausea, vomiting and loss of appetite.

About Corplex

Corium's Corplex system is a novel commercial-stage platform technology designed to broadly enable the transdermal delivery of small molecules, many of which have not previously been amenable to transdermal delivery.  Corplex advanced transdermal and transmucosal systems are broadly adaptable for use in multiple drug categories and indications, and have the potential to reduce quantities of active ingredient utilized in transdermal products.  Additionally, Corplex transdermal patches can enable efficient drug delivery, and adhere to either wet or dry surfaces for an extended period of time.  Corium's Corplex technology has been successfully commercialized in Procter & Gamble's Crest® Whitestrips products, and is being utilized in several proprietary therapeutic products under development.

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 clinical trial and regulatory timing and plans, 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.

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

EX-99.2

Exhibit 99.2

Corplex Donepezil® Pilot Bioequivalence Study Preliminary Results May 11, 2017

Forward-looking Statements This presentation and the accompanying oral presentation contain “forward-looking” statements that are based on our management’s beliefs and assumptions and on information currently available to management. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our business strategy, future financial and operating performance, business plans and objectives, potential growth and market opportunities, financing plans, competitive position, industry environment, product pipeline, clinical trial timing and plans, cash and resource requirements, clinical and regulatory pathways for our development programs, the achievement of clinical and commercial milestones, the advancement of our technologies and our proprietary, co-developed and partnered products and product candidates. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other factors including, but not limited to, those related to our future financial performance, market acceptance of our proprietary technology platforms for transdermal drug delivery, our ability to develop and maintain partnerships, our ability to identify, develop and market new products in a timely manner, our ability to maintain, protect and enhance our brand and intellectual property, and our ability to continue to stay in compliance with applicable laws and regulations. Moreover, we operate in a very competitive and rapidly changing environment, and new risks may emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. These factors, together with those that may be described in greater detail in our filings with the Securities and Exchange Commission (“SEC”), may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although our management believes that the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee that the future results, levels of activity, performance or events and circumstances described in the forward-looking statements will be achieved or occur. Moreover, neither we, nor any other person, assume responsibility for the accuracy and completeness of the forward-looking statements. These forward-looking statements speak only as of the date of this presentation, and we undertake no obligation to publicly update any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in our expectations, except as required by law.

Study Objectives and Preliminary Results Determine optimal patch size for Pivotal Bioequivalence (BE) Trial Establish intra-subject variability of AUC and Cmax Determine optimal number of subjects required in Pivotal BE Trial Demonstrate acceptable skin and gastrointestinal tolerability Demonstrate acceptable adhesion over one week Determine required frequency of blood sampling for Pivotal BE Trial Measure elimination half-life for both oral and patch (washout)

Preliminary Conclusion Although not an objective of this study, statistical bioequivalence was achieved

Donepezil Pilot Study: Overall Design and Timing Three period, three-treatment, randomized crossover study Period 1 Period 2 Period 3 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 ← Screening → PK PK PK Cohort 1 (20 subjects start) 5mg 10mg Aricept Oral Washout 5mg 10mg Patch B Washout 5mg 10mg Patch A Follow-Up ← Screening → PK PK PK Cohort 2 (20 subjects start) 5mg 10mg Patch A Washout 5mg 10mg Aricept Oral Washout 5mg 10mg Patch B Follow-Up ← Screening → PK PK PK Cohort 3 (20 subjects start) 5mg 10mg Patch B Washout 5mg 10mg Patch A Washout 5mg 10mg Aricept Oral Follow-Up Actual sequence of final two treatments was randomized Week Patch A and Patch B were two different patch sizes of the same formulation Drug-containing surface area of Patch B was ~20% larger than Patch A Steady-state PK assessments were made during 5th week of each period

Subject Demographics Demographic Distribution Age 20-78 years Male/Female 57% / 43% Non-Hispanic Caucasian/ Hispanic 75% / 25% 60 healthy volunteers enrolled at beginning of study Very low attrition: 50 completed the study >80% were more than 40 years old *At study initiation 4 6 15 23 9 3 20-30 31-40 41-50 51-60 61-73 74-84 Age Distribution*

Donepezil Projected Steady State PK Profile Solid Lines = Actual Phase 1 PK Data (Week 1) * Projections based on one-week PK study (September 2016, n=6) of Corplex Donepezil and one week PK study (June 2016, n=6) of oral Aricept Projected PK at Steady State

Observed PK Profiles at Steady State Oral PK measured only on Day 7 Plasma sampling for patch treatments taken throughout Week 5 Plasma sampling for Aricept taken only on last day (day 7) of Week 5 Transdermal Delivery Exhibits Similar PK Profile to Oral Aricept Patch A and B exhibit dose proportionality 0 10 20 30 40 50 60 70 0 1 2 3 4 5 6 7 Mean Plasma Donepezil Concentration (ng/ml) Days at Steady State (Week 5) Patch A (n=52) Patch B (n=51) 10 mg Oral Aricept (n=54) Oral Aricept Projected Daily PK

Bioequivalence Assessment of Patch A Primary PK Parameters Geometric Mean Ratio (%) (Patch A vs. Oral Aricept) BE Limits (Target 80-125%) AUCss (ng-hr/ml) 104.7 95.2 - 115.2 Cmaxss (ng/ml) 91.6 83.1 - 100.8 *AUCss - area under the curve at steady state (for patch, observed area under the curve throughout week 5; for Aricept, observed AUC day 7 of week 5 multiplied by 7) **Cmaxss - maximum concentration at steady state (for patch, maximum observed conc. during week 5; for Aricept, maximum observed conc. during day 7 of week 5) Patch A is Bioequivalent to Aricept BE requires the 90% confidence intervals for the geometric mean ratios of AUCss** and Cmaxss* for Patch A vs. Aricept to each be within 80-125%

Bioequivalence Assessment (Patch A) Primary PK Supportive PK** 125 80 Cmax AUCweek * At 90% confidence intervals The 80 – 125% criteria do not apply to supportive PK parameters; FDA has indicated that these will be tested for “no significant difference” compared to oral Aricept ** % Fluctuation data not shown; as expected, the patch achieved less fluctuation between Cmax and Cmin due to controlled delivery Cmin 100.8 115.2 102.3 113.1 121.3 121.2 118.2 116.7 112.8 127.3 83.1 95.2 84.2 92.1 99.3 99.5 97.5 97.2 94.6 98.4 91.6 104.7 92.8 102.1 109.8 109.8 107.3 106.5 103.3 111.9 Cmax AUC (week) AUC (Day 1) AUC (Day 2) AUC (Day 3) AUC (Day 4) AUC (Day 5) AUC (Day 6) AUC (Day 7) Cmin BE Limits*

Most Common GI* Side Effects * GI = Gastrointestinal Patch A incidence of nausea was more than 4x less than Aricept 4 2 4 10 13 2 7 12 17 5 9 12 0 2 4 6 8 10 12 14 16 18 Nausea Vomiting Diarrhea Constipation Number of Subjects GI Related Adverse Events, by Subject Count Patch A (n=54) Patch B (n=55) Aricept (n=58)

Favorable Skin Tolerability * Score on a rating scale of 0 (none) to 7 (strong reaction beyond patch application site) per FDA draft guidance on dermal response Percentage of patches exhibiting no irritation (score of 0) are not displayed in chart above Observed Skin Irritation (based on 340 applications of Patch A and Patch B) 80% of patches had an irritation score of “0” 18% 15% 12% 5% 3% 2% 1% 1% 0% 0% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Day 1 Day 2 Day 3 Day 5 Day 7 Percentage of Patches Days Post Patch Removal Score of 1* Score of 2*

Favorable Skin Adhesion Adhesion Score Adhered Portion(%) Observed Frequency(%) 0 100 65.9 1 ≥ 90 27.8 2 ≥ 80 4.4 3 ≥ 70 1.4 4 ≥ 60 0.2 5 ≥ 50 None 6 < 50 0.3 * Mean adhesion score derived from individual adhesion scores taken every 12 hours over the course of each one week treatment with Patch A and Patch B Observed Mean Adhesion Score* = 95.6% Target Objective: ≥90%

Patch A Wearability: Thin and Flexible ~150cm2 Delivers 7 Days of Drug Thinner Than a Dime

No Apparent BMI* or Age Effects No Apparent Effect of BMI or Age on AUCweek *BMI = Body Mass Index 20 30 40 50 60 70 80 Age (years) 18 20 22 24 26 28 30 32 AUC week BMI (kg/m 2 )

Finalize patch size for use in Pivotal Study (~11cm x 14cm) Manufacture three lots of final patch at 10% commercial batch scale Put samples from all three lots on long-term stability testing Meet with FDA this summer to reconfirm finalized study parameters Commence Pivotal Study in September/October 2017 Preliminary Results expected in February 2018 File NDA as early as Q3 CY 2018 Next Steps

Pilot Pivotal 3-way crossover, randomized 2-way crossover, randomized Healthy Volunteers Healthy Volunteers Enroll 60 to complete at least 30 (50 actually completed) Enroll 64-100 to complete 54-86 (to be finalized mid-June) 3 treatments (2 patch sizes and oral Aricept) 2 treatments (Final patch size and oral Aricept) Each Period = 5 weeks of treatment (5mg Week 1 followed by 10 mg Weeks 2-5) Each Period = 5 weeks of treatment (5mg Week 1 followed by 10mg Weeks 2-5) 3-week washout 5-week washout Primary Objective: Assess Cmax and AUC Primary Objective: BE for Cmax and AUC Study Duration: 6 months 5 months Pivotal Study Design More Streamlined

Donepezil Pivotal Study Design Each subject will be randomized into one of two treatment sequences Period 1 Period 2 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 PK PK Cohort 1 Screening 5mg Oral 10mg Aricept Oral Extended Washout 5mg Patch 10mg Final Patch Follow-Up PK PK Cohort 2 Screening 5mg Patch 10mg Final Patch Extended Washout 5mg Oral 10mg Aricept Oral Follow-Up Week

Expected Donepezil Pathway to Commercialization 2016 2017 2018 2019 2020 2021 Pilot BE Study Pivotal BE Study File NDA Commercialize Patch A Achieved Bioequivalence Section 505(b)(2) File in 2H 2018 PDUFA in 2H 2019 U.S. Launch in 2H 2019 EU in 2020/2021 Japan in 2022 Two-way Crossover Start in September/October Preliminary Data in February All years are calendar years

Study Objectives and Preliminary Results Determine optimal patch size for Pivotal BE Trial Establish intra-subject variability of AUC and Cmax Determine optimal number of subjects required in Pivotal BE Trial Demonstrate acceptable skin and gastrointestinal tolerability Demonstrate acceptable adhesion over one week Determine required frequency of blood sampling for Pivotal BE Trial Measure elimination half-life for both oral and patch (washout)

Nasdaq: CORI