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): July 28, 2015

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):

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

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

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

oPre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 7.01. Regulation FD.

On July 28, 2015, Corium International, Inc. (the “Company”) issued a press release announcing topline results from its Phase 2a study of Transdermal MicroCor PTH.  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 third fiscal quarter earnings conference call scheduled at 4:30 p.m. Eastern time on July 29, 2015.  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 July 28, 2015.
99.2	Presentation materials for conference call on July 29, 2015.

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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: July 28, 2015	By:	/s/ Peter D. Staple
		Peter D. Staple
		Chief Executive Officer

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INDEX TO EXHIBITS

Exhibit Number	Description of Exhibit
99.1	Press release dated July 28, 2015.
99.2	Presentation materials for conference call on July 29, 2015.

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EX-99.1

Exhibit 99.1

Corium Announces Positive Topline Results from Phase 2a Study of Transdermal MicroCor® PTH in Post-Menopausal Women

Demonstrates Rapid Drug Uptake, Significant Increases in Bone Formation Biomarkers and Excellent Skin Tolerability

Company to Webcast Third Quarter Fiscal 2015 Results and Discussion of Topline Clinical Results on Wednesday, July 29th

MENLO PARK, Calif., July 28, 2015 — Corium International, Inc. (Nasdaq:CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced positive topline interim results from its Phase 2a study designed to determine the pharmacokinetics (PK), pharmacodynamics (PD) and safety and tolerability of its MicroCor transdermal system for the rapid delivery of a treatment for osteoporosis.  The product delivers human parathyroid hormone, or hPTH(1-34) (known as teriparatide), a peptide that has been clinically proven to stimulate formation of new bone and reduce the risk of fractures.  Teriparatide is approved for the treatment of osteoporosis by the U.S. Food and Drug Administration (FDA) as a daily injection.  The MicroCor transdermal system uses a novel biodegradable microstructure technology capable of delivering a wide range of drugs as an alternative to daily injections.

The Phase 2a study was conducted as a two-part clinical trial:

·Part A was designed to evaluate single dose PK and the safety and tolerability of MicroCor PTH in healthy post-menopausal women, compared to the only approved hPTH(1-34) therapy, Eli Lilly’s Forteo® (teriparatide (rDNA origin) injection)

·Part B of the study was designed to evaluate the PK and the safety and tolerability of PTH delivered for 28 consecutive days via either the MicroCor needle-free system or Forteo subcutaneous injection.  Doses were initially administered at the investigational site followed by self-administration at home or in the clinic for a total of 28 days per subject.  PD was evaluated by measuring changes in levels of well-characterized bone biomarkers.

Key topline results from the Phase 2a study:

·Rapid uptake and clearance of hPTH(1-34) in a pulsatile delivery profile was demonstrated in the blood concentrations of all subjects treated with the MicroCor PTH system.  Pulsatile delivery of hPTH(1-34) is known to be an important factor in stimulating bone formation.

·The PK profiles in the 33 subjects aged 50-85 treated with MicroCor in the Phase 2a study were consistent with those of the 16 subjects aged 18-35 treated in the Phase 1 study, demonstrating the reproducibility of the MicroCor system’s rapid-onset capability across a wide range of ages.

·The PK profile of MicroCor PTH was dose proportional across the two doses administered in the study.

·Subjects exhibited similar PK profiles at Day 1 of treatment compared to Day 28, indicating the absence of drug accumulation from sequential daily treatments.

·Increases in serum concentrations of bone-formation markers that are widely understood to be consistent with bone-building activity were comparable among subjects treated with MicroCor PTH and those treated with Forteo injections.

·Subjects treated with MicroCor PTH experienced excellent skin tolerability and no systemic adverse events beyond those observed in subjects treated with Forteo injections.  All subjects treated with MicroCor PTH completed the trial.

·Results support advancing the MicroCor PTH transdermal system into late-stage clinical development in osteoporotic patients.

“These Phase 2a results met each of the trial’s objectives, and provide a solid basis for advancing the MicroCor PTH product into late-stage clinical development,” said Parminder “Bobby” Singh, Ph.D., Chief Technology Officer and Vice President, Research and Development at Corium.  “The data demonstrate a rapid uptake of hPTH(1-34), a pharmacokinetic profile that is consistent with our earlier studies in younger subjects, and pharmacodynamics in post-menopausal women consistent with the known activity of hPTH(1-34) in promoting bone growth.  With more than 600 applications of MicroCor in our Phase 1 and Phase 2a studies combined, we have now validated that our MicroCor platform provides robust and reproducible drug delivery with excellent skin safety across a wide range of age groups.”

Study Design

The study was performed at a single trial site in Australia and enrolled 39 postmenopausal women aged 50 to 85 (mean age of 63 years).

Part A of the study was a single-dose, crossover study of 18 subjects.  Subjects were randomized to one of the three initial treatment arms:  MicroCor PTH 16 mcg, MicroCor PTH 38 mcg or Forteo® 20 mcg injection.  The primary objective was to assess the single dose PK of MicroCor PTH compared to Forteo injection.  The secondary objectives were assessment of safety and tolerability and dose proportionality between the 16 mcg and 38 mcg MicroCor PTH systems.

Part B of the study was a 28-day, multiple dose, parallel group study of 21 subjects.  All study participants were taught self-administration techniques in a clinical setting, after which they self-administered their medication at home or in the clinic.  Subjects were randomized to two treatment groups:  MicroCor PTH 38 mcg, or Forteo 20 mcg injection.  The MicroCor PTH patch was applied to a naïve skin site on the lateral abdomen for five minutes on a daily basis for 28 days.  The Forteo 20 mcg/daily injection was administered in the abdomen wall.  Study participants were assessed periodically at the clinic after randomization.  The primary objective was to assess the multiple dose PK of MicroCor PTH compared to Forteo injections.  The secondary objectives were assessment of safety and tolerability and changes in serum levels of bone biomarkers.

Corium plans to submit the full results of this Phase 2a study for presentation at a future scientific meeting following completion of ongoing analysis.

Conference Call and Webcast Details

Corium will host a conference call and live webcast to report financial results for the Third Quarter Fiscal 2015, and Corium’s Chief Technical Officer Dr. Bobby Singh will join to discuss topline results from the Phase 2a study of MicroCor PTH on Wednesday, July 29, 2015 at 4:30 p.m. Eastern time, 1:30 p.m. Pacific time.

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 97011877.  The conference call will also be available via a live audio webcast on the Investors section of Corium’s website at http://ir.coriumgroup.com/events.cfm.  Please access the website 10 minutes prior to the start of the call to ensure adequate time for any software downloads that may be necessary.  A replay of the conference call will be available for two weeks and may be accessed by dialing toll-free 855-859-2056 (United States) or +1 404-537-3406 (international) and entering the conference ID # 97011877 or by visiting Corium’s website.

About MicroCor®

Corium’s MicroCor system is a clinical-stage platform technology utilizing dissolving microstructures for the safe, effective and convenient transdermal delivery of small molecules and biologics, including vaccines, peptides and proteins.  Corium’s “drug-in-tip” technology directly integrates active therapeutic agents with proprietary polymer combinations to create arrays of solid-state biodegradable microstructures, or “microneedles,” to optimally deliver therapeutic or prophylactic agents either locally or systemically.  MicroCor is designed to penetrate the superficial layers of the skin, eliminating bleeding and the discomfort associated with traditional injections.  Unlike liquid injectable formulations, the solid-state nature of the MicroCor system enables room-temperature stability, simplifying handling, storage and reducing spoilage.  In addition, there are no needles or sharps left behind after use, providing a safer delivery system for healthcare workers and caregivers.  Corium has established GMP manufacturing facilities and quality systems for scale-up, and has developed cost-effective manufacturing processes to support early-stage through clinical development programs.

About Osteoporosis and Parathyroid Hormone

Osteoporosis is a disease characterized by low bone mass and structural deterioration of bone tissue, leading to bone fragility and an increased susceptibility to fractures.  According to the National Osteoporosis Foundation, about 54 million Americans have osteoporosis and low bone mass, placing them at increased risk for fractures. Studies suggest that approximately one in two women and up to one in four men age 50 and older will break a bone due to osteoporosis.  By 2025, experts predict that osteoporosis will be responsible for 3 million fractures resulting in an estimated $25.3 billion in costs each year.

Human parathyroid hormone, or hPTH, is a natural hormone that acts to regulate calcium and phosphate metabolism in bone.  hPTH(1-34) has an identical sequence to the 34 N-terminal amino acids (the biologically active region) of the 84-amino acid human parathyroid hormone.  The skeletal effects of hPTH(1-34) depend upon the pattern of systemic exposure.  Once-daily administration of hPTH(1-34) stimulates new bone formation by preferential stimulation of osteoblastic (bone forming) activity over osteoclastic (bone resorption) activity.  In contrast, a continuous high concentration of endogenous PTH in the blood stream, as seen in hyperparathyroidism, may be detrimental to bone health because bone resorption may be stimulated more than bone formation.

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 advanced transdermal and transmucosal delivery systems.  Corium has developed and is the sole commercial manufacturer of six prescription drug and consumer products with partners Teva Pharmaceuticals, Par Pharmaceutical 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 is currently in Phase 3 trials, and additional transdermal products that are being co-developed with Teva.  Corium has multiple proprietary programs in preclinical and clinical development for the treatment of osteoporosis and neurological disorders. 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, clinical trial plans and the advancement of our technologies and our proprietary 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 financial results are detailed in Corium’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, filed with the Securities and Exchange Commission on May 8, 2015, 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 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.

# # #

Investor and Media Contact:

Karen L. Bergman or Susan Pietropaolo

BCC Partners

kbergman@bccpartners.com or spietropaolo@bccpartners.com

650-575-1509 or 845-638-6290

EX-99.2

© 2015 Corium All Rights Reserved. Corium International, Inc. July 28, 2015 MicroCor hPTH(1-34) Phase 2a Interim Topline Results

MicroCor Platform Overview ~10 mm ~200 µm ~40 mm Applicator Array Cross-Section

MicroCor Operation Dissolvable Drug-in-Tip Insoluble Backing Layer Controlled Application Stratum Corneum Dermis Blood vessels Epidermis ~200µm

Phase 2a Study Overview Part A Pharmacokinetics (PK) 18 Subjects 3 Days In-clinic 2 MicroCor Doses + Forteo Injection Part B PK + Pharmacodynamics (PD) 21 Subjects 28 Days Take-home 1 MicroCor Dose or Forteo Injection . Part A: PK only; FDA guidance to demonstrate PK in target age group - Crossover design reduced variability among subjects . Part B: PD + PK; biomarkers evaluated to provide proof-of-concept - Biomarker carry-over precluded crossover study design

 Phase 2a—Part A Design (PK Only) . Single-dose, randomized, crossover study .18 healthy post-menopausal women (50-85 years of age) . Per FDA guidance, two MicroCor doses to establish dose proportionality: – 16 mcg targeted to achieve Cmaxcomparable to Forteo – 38 mcg targeted to achieve AUC* comparable to Forteo . Forteo20 mcg subcutaneous injection as comparator . Three consecutive days of treatment, each subject receiving all three treatments . Primary endpoint: compare MicroCor and Forteo PK . Secondary endpoints: safety, tolerability, and dose proportionality *AUC = Area Under the Curve, a measure of the total drug delivered to the bloodstream

 Phase 2a—Part B Design (PK/PD) . Multiple-dose, randomized, parallel groups .21 healthy post-menopausal women (50-85 years of age) . Two treatment groups: – 38 mcg MicroCor(n=15) – 20 mcg Forteosubcutaneous injection (n=6) . Each subject dosed once per day for 28 consecutive days . First 4 doses applied by clinic staff, remainder self-administered by subjects . Primary endpoint: compare MicroCor and Forteo PK at Days 1 and 28 . Secondary endpoints: safety, tolerability, and changes in bone biomarkers

0 50 100 150 200 0 1 2 3 4 hPTH(1-34) plasma concentration (pg/ml) Hours MicroCor 38 mcg Day 1 (n=15) MicroCor 38 mcg Day 28 (n=14) Forteo 20 mcg Day 1 (n=6) Forteo 20 mcg Day 28 (n=4) Rapid and Pulsatile Pharmacokinetics . Dose proportional: Supports dose selection for Phase 2B . No drug accumulation: Consistent with the short half-life of PTH 0 50 100 150 200 0 1 2 3 4 hPTH(1-34) plasma concentrations (pg/ml) Hours MicroCor 38 mcg (n=18) MicroCor 16 mcg (n=18) Forteo 20 mcg (n=18) AUC comparable to Forteo Cmaxcomparable to Forteo Part A Part B Limit of detection

 . PK profiles similar for younger (18-35) and older (50-85) subjects . Phase 1 PK profile reviewed with FDA as basis for Phase 2 study design Phase 2a PK Profiles Similar to Phase 1 0 50 100 150 200 0 1 2 3 4 hPTH(1-34) plasma concentrations (pg/ml) Hours MicroCor Phase 1 (n=16) MicroCor Phase 2a (n=18)

 0 100 200 300 400 AUC (pg*hr/mL) Reliable and Reproducible Dosing CV=49% CV=30% . AUC variability in MicroCor PTH comparable to Forteoinjections MicroCor 38µg Forteo 20µg CV=43% MicroCor 38µg Forteo 20µg CV=32% Part A Part B CV=41% Day 1 Day 28 MicroCor 38µg

Increase In Bone Formation Biomarker *P1NP – Procollagen Type 1 N-terminal propeptide 0 50 100 150 0 7 14 21 28 35 42 49 56 P1NP (% change from baseline) Days MicroCor 38 mcg (n=14) Forteo 20 mcg (n=4) Treatment stopped . Serum P1NP* levels indicative of bone formation activity . Increase in P1NP with MicroCor similar to Forteo during 28-day treatment . Marker is predictive of BMD response (primary endpointin Phase 2b/3) P1NP

-40 -20 0 20 40 60 0 7 14 21 28 35 42 49 56 CTX (% change from baseline) Days Forteo 20 mcg (n=4) MicroCor 38 mcg (n=14) Little Change in Bone Resorption Biomarker *CTX – collagen Type 1 cross-linked linked C-telopeptide . Higher serum levels of CTX* are indicative of bone loss . CTX levels with MicroCor essentially unchanged compared to baseline . Forteo showed an increase in CTX starting at day 21 Treatment stopped CTX

Excellent Safety and Skin Tolerability .545 MicroCor applications in Phase 2a showed excellent skin tolerability –95% of applications resulted in minimal (score of 1/8) skin irritation (erythema only) – Highest reported score was 2/8 – E rythema was transient, limiting and self-resolving – No other application-related skin reactions reported/observed – No evidence of contact sensitization after 28 days of sequential daily use . Systemic safety – No serious adverse events reported – Observed adverse events similar to Forteo; none unique to MicroCor – Lower frequency of drug-related adverse events compared to Forteo(64% vs. 83%)

Key Phase 2a Conclusions .Excellent safety and skin tolerability .Rapid and reproducible PK in target age group (50-85) .Results confirmed PK profile seen in younger Phase 1 study age group (18-35) .Bone biomarkersconsistent with Forteo .Ease and reproducibility of self-administration validated Results support advancing into Phase 2b testing in osteoporotic patients

Planned Phase 2b Trial Design .Efficacy andsafety study in 150-200 post-menopausal osteoporotic women .Three MicroCor doses with Forteo 20 mcg as active comparator .Six-month study duration with daily self-administration of treatments .Trial could commence in late CY 2016 .Partnering or co-development could affect timing Primary Endpoint: Changes in BMD at lumbar spine at 6 months Secondary Endpoints:Changes in BMD at hip, bone biomarkers, safety, and skin tolerability

© 2015 Corium All Rights Reserved. Corium International, Inc. July 28, 2015 Nasdaq: CORI