cori_Current Folio_8K

 

 

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): February 28, 2018

 

 

 

 

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 8.01. Other Events.

 

Proposed Offering of Convertible Senior Notes due 2025

 

On February 28, 2018, Corium International, Inc. (“Corium”) issued a press release announcing that it proposes to offer, subject to market conditions and other factors, $100,000,000 aggregate principal amount of Convertible Senior Notes due 2025 (the “Notes”) in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Corium also intends to grant the initial purchaser of the Notes a 13-day option to purchase up to an additional $20,000,000 aggregate principal amount of Notes.

 

Announcement of Feedback from FDA

 

The press release also announced that, in February 2018, Corium received feedback via email from the U.S. Food and Drug Administration (the “FDA”) that the FDA had completed its preliminary review of data submitted before and after Corium’s August 2017 meeting with the FDA and that the results of Corium’s pilot bioequivalence study for Corplex Donepezil may, on their face, suffice as the sole basis for demonstrating bioequivalence between Corplex Donepezil and oral Aricept for the purpose of submitting a New Drug Application (“NDA”).  The FDA confirmed that the final acceptability of the results of the pilot study for approval purposes would be determined by the FDA’s review of Corium’s NDA, once submitted.  Corium is in the process of evaluating the optimal path forward based on this feedback, taking into consideration that dosing in Corium’s pivotal bioequivalence trial has already been completed. Full review of a data package is required for an NDA review, and there can be no assurance that the FDA would ultimately conclude that the pilot study is sufficient to support bioequivalence or that the FDA would approve an NDA filed on that basis.

 

A copy of the press release announcing the proposed offering of the Notes and the FDA feedback is attached hereto as Exhibit 99.1 and is incorporated herein by reference. A copy of the investor presentation for the proposed offering of Notes, which Corium does not undertake to update, is attached hereto as Exhibit 99.2 and is incorporated herein by reference.  

 

Forward Looking Statements

 

This report contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended, that involve risks and uncertainties, including, without limitation, statements regarding Corium’s proposed offering of the Notes and expected use of net proceeds of the offering, clinical trial and regulatory timing and plans, and advancement of technologies and products and product candidates. Statements containing words such as “could,” “believe,” “expect,” “intend,” “will,” or similar expressions constitute forward-looking statements. Forward-looking statements are based on management's current expectations and projections and are subject to risks and uncertainties, which may cause actual events and results to differ materially from the statements contained herein. Factors that may contribute to such differences include, but are not limited to, risks related to whether Corium will consummate the offering of the Notes on the expected terms, or at all, the anticipated principal amount of the Notes, prevailing market and other general economic conditions, whether Corium will be able to satisfy the conditions required to close any sale of the Notes, and the fact that Corium’s management will have broad discretion in the use of the proceeds from any sale of the Notes. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. For information about other potential factors that could affect Corium’s business and results, please review the “Risk Factors” described in Corium’s Annual Report on Form 10-K for the year ended September 30, 2017 and Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2017 filed with the Securities and Exchange Commission (the “SEC”), and in Corium’s other filings from time to time with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as may be required by law, Corium does not intend, and undertakes no duty, to update 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.

 

 

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits.

 

 

 

 

Exhibit 

Number

    

Description

 

 

 

99.1

 

Press release dated February 28, 2018 announcing the proposed offering of the Notes and FDA feedback. 

99.2

 

Investor presentation for the proposed offering of the Notes.

 

 

 

 


 

INDEX TO EXHIBITS

 

 

 

 

 

 

 

Exhibit

Number

    

Description of Exhibit

 

 

 

99.1

 

Press release dated February 28, 2018 announcing the proposed offering of the Notes and FDA feedback.

99.2

 

Investor Presentation for the proposed offering of the Notes.

 

 

 

 


 

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: February 28, 2018

 

By:

/s/ Robert Breuil

 

 

 

Robert Breuil

 

 

 

Chief Financial Officer

 


cori_Ex99_1

Exhibit 99.1

 

Corium Announces Proposed Offering of $100 Million of Convertible Senior Notes; Receives FDA Feedback on Pilot Bioequivalence Study

 

MENLO PARK, Calif., February 28, 2018 (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 that it intends to offer, subject to market conditions and other factors, $100,000,000 aggregate principal amount of Convertible Senior Notes due 2025 (the “notes”) in a private offering to qualified institutional buyers pursuant to the Securities Act of 1933, as amended (the “Securities Act”). Corium also intends to grant the initial purchaser of the notes a 13-day option to purchase up to an additional $20,000,000 aggregate principal amount of notes.

 

Cantor Fitzgerald & Co. is acting as the sole manager for the offering.

 

The notes will be senior, unsecured obligations of Corium, and interest will be payable semi-annually in arrears. The notes will mature on March 15, 2025 and be convertible, at the option of the holders, into shares of Corium’s common stock. The interest rate, initial conversion rate, initial effective conversion price and other terms of the notes will be determined at the time of pricing of the note offering.

 

Corium intends to use approximately $56 million to repay in full its outstanding borrowings under its term loan agreement with CRG, and the remainder for working capital and other general corporate purposes.

 

This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities (including the shares of Corium’s common stock, if any, into which the notes are convertible) and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. Any offers of the notes will be made only to qualified institutional buyers pursuant to Rule 144A under the Securities Act.

 

The notes and any shares of Corium’s common stock issuable upon conversion of the notes have not been and will not be registered under the Securities Act, or any state securities laws, and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.

 

In February 2018, Corium received feedback via email from the U.S. Food and Drug Administration (the “FDA”) that the FDA had completed its preliminary review of data submitted before and after Corium’s August 2017 meeting with the FDA and that the results of Corium’s pilot bioequivalence study for Corplex Donepezil may, on their face, suffice as the sole basis for demonstrating bioequivalence between Corplex Donepezil and oral Aricept for the purpose of submitting a New Drug Application (“NDA”).  The FDA confirmed that the final acceptability of the results of the pilot study for approval purposes would be determined by the FDA’s review of Corium’s NDA, once submitted.  Corium is in the process of evaluating the optimal path forward based on this feedback, taking into consideration that dosing in Corium’s pivotal bioequivalence trial has already been completed. Full review of a data package is required for an NDA review, and there can be no assurance that the FDA would ultimately conclude that the pilot study is sufficient to support bioequivalence or that the FDA would approve an NDA filed on that basis.

 

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.  In addition to its proprietary Alzheimer's program, 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.coriumintl.com.

 


 

Forward Looking Statements

 

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties, including, without limitation, statements regarding Corium’s proposed offering of the notes and expected use of net proceeds of the offering, clinical trial and regulatory timing and plans, and advancement of technologies and products and product candidates. Statements containing words such as “could,” “believe,” “expect,” “intend,” “will,” or similar expressions constitute forward-looking statements. Forward-looking statements are based on management's current expectations and projections and are subject to risks and uncertainties, which may cause actual events and results to differ materially from the statements contained herein. Factors that may contribute to such differences include, but are not limited to, risks related to whether Corium will consummate the offering of the notes on the expected terms, or at all, the anticipated principal amount of the notes, prevailing market and other general economic conditions, whether Corium will be able to satisfy the conditions required to close any sale of the notes, and the fact that Corium’s management will have broad discretion in the use of the proceeds from any sale of the notes. The foregoing list of risks and uncertainties is illustrative, but is not exhaustive. For information about other potential factors that could affect Corium’s business and results, please review the “Risk Factors” described in Corium’s Annual Report on Form 10-K for the year ended September 30, 2017 and Quarterly Report on Form 10-Q for the quarterly period ended December 31, 2017 filed with the Securities and Exchange Commission (the “SEC”), and in Corium’s other filings from time to time with the SEC. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as may be required by law, Corium does not intend, and undertakes no duty, to update 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:

SMP Communications

Susan M. Pietropaolo

susan@smpcommunications.com

(201) 923-2049  

 


cori_Ex99_2

Exhibit 99.2

 

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Corium Investor Update

 


 

 

 

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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.

 


 

 

 

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Proven Leadership Team Peter Staple Chief Executive Officer Robert Breuil Chief Financial Officer Joseph Sarret, MD Chief Business Officer Bobby Singh, PhD Chief Technology Officer Tim Sweemer, CPA Chief Accounting Officer Dan Arsulowicz VP Operations Grand Rapids Christina Dickerson VP Corporate Development Great Pacific Capital

 


 

 

 

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Transdermal solutions that transform care Leading Transdermal Product Innovation Vision Building a robust pipeline of novel CNS products Streamlined path for donepezil Alzheimer’s program Approach Lead Product 15+ years of development & manufacturing expertise Core Strengths

 


 

 

 

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Partner Product Application Status Clonidine TDS Hypertension Marketed Fentanyl TDS Pain Marketed Crest® Whitestrips (5 Products) Teeth Whitening Marketed Twirla® Contraception NDA filed Undisclosed Motion Sickness ANDA filed Strong Track Record in Transdermal Products Commercial and late-stage partnered programs

 


 

 

 

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Enabling Sustained Delivery: Corplex™ Technology Can adhere to both dry and wet surfaces Sustained drug delivery up to 7 days Load large amounts of drug/liquid Uniquely well-suited for poorly soluble drugs Enables first-in-patch products Overcomes limitations of other technologies Novel combinations of pressure-sensitive and bioadhesive polymers

 


 

 

 

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Exelon Daily Patch Alzheimer’s: Transformational Market Opportunity 9% 50% 39% $0.5 $4.2 $2.3 $1.1 Rivastigmine (Exelon®) Donepezil (Aricept®) Memantine (Namenda®) 2015 U.S. TRx Share Peak WW Oral Sales (Billions) Peak WW Patch Sales (Billions) CNS Specialty Pharma Opportunity Alzheimer’s Treatments Sources: QuintilesIMS NPA Extended Insights data extracted in December 2016 and Novartis SEC filings

 


 

 

 

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Validated Pricing for Branded Transdermal Products 2015 TRx* in U.S. for Acetylcholinesterase Inhibitor (AChEI) Class = 13.3M Each 1% in U.S. market share = 133K TRx Each 1% of branded U.S. AChEI market = $103M * Source: QuintilesIMS NPA Extended Insights data extracted in December 2016. TRx = Total Prescriptions (new plus refills) On average, each TRx represents 1.3 months’ of drug † Source: 2017 Redbook Branded Exelon patch monthly WAC† = $594

 


 

 

 

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Physician Intent to Prescribe is High Q: How likely are you to prescribe Corplex Donepezil to your Alzheimer’s patients? Probably (42%) Definitely (29%) Undecided Probably not (5%) Definitely not (2%) Likely Not likely U.S. survey of 310 physicians; 235 primary care physicians and 75 neurologists Assumes $40/month copay and no benefit in GI adverse events Interest level increases with severity of disease Copay costs are an important attribute in treatment choice Source: Primary research conducted by AplusA Bell Falla LLC on behalf of Corium Doctors: ~1/3 of patients cannot go beyond 5mg IMS: ~30% of TRx are for 5mg: 2014 29% 2015 30% 2016 31%

 


 

 

 

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Intent to Fill Prescription Q: “Assume the doctor for the person you care for wrote that person a prescription for a one-month supply of PRODUCT D*. How likely is it that the PRODUCT D prescription would be filled for the person you care for?” 87% 87% 87% 94% (n=281) (n=158) (n=175) (n=50) Survey of 300 U.S. caregivers: numbers in parentheses indicate number of patients in survey being treated with that agent (some patients were on more than one agent). Percentages <1% are not shown in chart. Caregiver Interest and Intent to Fill is High % in top 2 boxes: *Respondents were told to assume a $40/month copay and that PRODUCT D would have no improvement in GI adverse events vs. oral Aricept Source: Primary research conducted by an independent third party on behalf of Corium

 


 

 

 

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Positive FDA Guidance on Bioequivalence Pathway FDA agreed with proposed BE approach for both donepezil and memantine CY 2016 written responses confirmed clinical study designs and regulatory pathway A pilot BE to study two patch sizes, followed by a pivotal BE study of the final patch size Key factor is long half life: donepezil = 70 hours; memantine = 60-80 hours Both reach steady state in 3-4 weeks Studies target bioequivalence (BE) to oral Aricept® and oral Namenda XR® Requires statistically similar patterns of blood concentrations over time Evaluated at steady state (during Week 5); healthy subjects Substantially reduces time, cost and complexity of clinical program August 2017 meeting with FDA reconfirmed Corium’s BE pathway

 


 

 

 

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Phase 1 Projected* PK Profile Out to Steady State SOLID Lines = Actual Phase 1 PK Data (Week 1) Projected PK at Steady State (Week 4) * Projections based on one-week PK study (Sep 2016, n=6) of Corplex Donepezil and one week PK study (Jun 2016, n=6) of Oral Aricept

 


 

 

 

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Pilot Study: 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

 


 

 

 

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Bioequivalence: Primary and Supportive PK Statistics Primary PK Supportive PK** 125 80 * 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 Cmax AUCweek

 


 

 

 

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Most Common GI* Side Effects * GI = Gastrointestinal Corplex incidence of nausea was nearly 6x less than Aricept 29% 7% 4% 7% 19% 20% 9% 33% 6% 2% 6% 17% 21% 10% 19% ~6x ~5x

 


 

 

 

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Donepezil Pivotal Study Design Each healthy subject was 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 Enrolled 86 subjects → Completed 78 Feb 12

 


 

 

 

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Donepezil: Clear Pathway to Commercialization 2017* 2018 2019 2020 Ancillary Studies CMC, Stability, NDA Preparation NDA Review PDUFA Q4 2019 Commercialize * All years are calendar years Studies Pivotal Bioequivalence Irritation & Sensitization Alternative Site Absorption Heat Effect Dermal Toxicity (Animal) Dosing complete >50% complete Starting in February >25% complete >75% complete

 


 

 

 

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FY2018 Q1 Total Revenues of $9.3M (+34% YoY) $5.9M in Product Revenues $3.2M Contract R&D Revenues Sole supplier of Crest Whitestrips for P&G; 5-year extension signed 2017 $45.2M in unrestricted cash at December 31, 2017 $52.3M in long-term debt (primarily with CRG, due June 2019) 36.1M shares outstanding as of December 31, 2017 >10% holders: Essex Woodlands (26%) and Perceptive Advisors (18%) Financial Highlights at December 31, 2017

 


 

 

 

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High-value CNS pipeline opportunity and strong IP Corplex Memantine complements Alzheimer’s portfolio New Phase 1 programs in CY 2018 to expand CNS specialty franchise Corium: Growth and Momentum in 2018 Building on 15+ years of development and commercial manufacturing Twirla has potential to drive significant upside in partner business An integrated transdermal products engine Our Approach: Commercialize Transformational CNS Products Lower-risk bioequivalence path tracking toward launch by late 2019 Major clinical de-risking achieved in pilot study; pivotal data in 2Q CY2018 Corplex Donepezil – lead product in Alzheimer’s disease

 


 

 

 

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Nasdaq: CORI