cori_CurrentFolio_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): August 9, 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 2.02. Results of Operations and Financial Condition.

On August 9, 2018,  Corium International, Inc. (the “Company”) issued a press release to announce its financial results for its third fiscal quarter ended June 30, 2018.  A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference.

The information furnished with this report, including Exhibit 99.1, 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 June 30, 2018.

 

 

 

INDEX TO EXHIBITS

 

 

 

 

Exhibit

Number

    

Description of Exhibit

 

 

 

99.1

 

Press release dated June 30, 2018.

 

 

 


 

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: August 9, 2018

 

 

By:

 /s/ Robert Breuil

 

 

 

 

Robert Breuil
Chief Financial Officer   

 

 

 

 

 

 

 


cori_Ex99_1

Exhibit 99.1

 

Corium Reports Third Quarter Fiscal 2018 Financial Results and Corporate Highlights

 

MENLO PARK, Calif., August 9, 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 unaudited financial results for the third fiscal quarter and the nine months ended June 30, 2018 and reported on recent corporate developments.  Corium's fiscal year ends on September 30.

 

Corporate Highlights

 

·

Corplex™ Donepezil on track for filing  Corium has completed treatment in all of the ancillary clinical studies required for its New Drug Application (NDA) for Corplex Donepezil, a once-weekly patch that delivers the most commonly prescribed medication for Alzheimer’s patients.  These studies included standard skin tolerability, alternative patch application site and heat effect studies.  Corium remains on track to submit a Section 505(b)(2) NDA in the first quarter of calendar 2019.  In addition, Corium reported clinical pharmacodynamic results at the Alzheimer's Association International Conference® 2018 that provide additional validation of the therapeutic equivalence between Aricept® and Corplex Donepezil.   

 

·

First two key patents issued for Corplex Donepezil —  In June and July, Corium announced the issuance of two U.S. patents, including composition elements, unique design features of the drug product and methods to achieve sustained, controlled and effective delivery of donepezil across the skin for a 7-day wear period.  Eligible for listing in the FDA Orange Book, these patents establish the foundation of a strong IP portfolio for the transdermal delivery of donepezil and extend patent coverage of the product to at least July 2037.  Corium has several additional pending patent applications relating to various features of Corplex Donepezil, as well as similar products.

 

·

Pipeline advances in additional indications  Corium has progressed its development and feasibility evaluation of several pipeline product candidates, leveraging nonclinical and clinical studies that the company has already performed.  The pipeline candidates include programs in several important disease areas including multiple sclerosis, Alzheimer’s and pain management.  Corium anticipates advancing select programs into clinical pharmacokinetic and safety studies during fiscal 2019.

 

·

Commercial production commenced using expanded capacity for P&G  Corium’s expanded commercial manufacturing capacity for Procter & Gamble’s Crest® Whitestrips is now fully operational and in production.  Part of an extended


 

supply agreement with P&G, the additional production provides the companies with greater ability to meet significant increases in demand for Crest Whitestrips.

 

"We remain on track to file our Corplex Donepezil NDA in the first quarter of 2019 and look forward to delivering an important new treatment option for patients with Alzheimer’s disease and their caregivers,” said Peter D. Staple, President and Chief Executive Officer of Corium.  “We are executing on our strategic plan to leverage our Corplex technology to expand our proprietary pipeline with the development of additional “first-in-patch” transdermal therapeutics.  We’ve identified several promising candidates in therapeutic areas with significant unmet needs that, based on our initial formulation and feasibility work, meet our technical and commercial criteria for further development.” 

 

Financial Results for the Quarter and Nine Months Ended June 30, 2018

 

Corium reported total revenues of $7.7 million for the third quarter of fiscal 2018, compared with $8.1 million for the same period of fiscal 2017, and reported total revenues of $27.0 million for the nine-month period ended June 30, 2018, compared with $22.4 million for the same period in fiscal 2017.  Product revenues were essentially unchanged for the third quarter of fiscal 2018, compared to the same period in fiscal 2017,  primarily as a result of a decrease in Clonidine TDS revenues, offset by an increase in revenues from Crest Whitestrips and Fentanyl TDS.  Product revenues increased for the nine-month period ended June 30, 2018, compared to the same period in fiscal 2017, as revenues from Procter & Gamble increased, reflecting strong demand for the Crest Whitestrips products.  Contract research and development (R&D) revenues decreased for the third quarter of fiscal 2018, compared to the same period in fiscal 2017,  as a result of reduced development work for Agile’s Twirla® product and several other partner programs, partially offset by higher revenues from activities associated with implementing the new production capacity for P&G.    Contract R&D revenues increased for the nine-month period ended June 30, 2018, compared to the same period in fiscal 2017,  due to increased support for Agile’s regulatory activities, increased product development for Mayne, and the implementation of the new production capacity for P&G.  

 

Total R&D expenses were $10.6 million in the third quarter of fiscal 2018, compared with $12.1 million in the same period of fiscal 2017, and were $39.7 million for the nine-month period ended June 30, 2018, compared with $30.5 million in the same period in fiscal 2017.  The decrease in total R&D expenses for the third quarter reflects the lower level of clinical activity for Corplex Donepezil during this period.  The increase in total R&D expenses for the nine-month period was driven by Corium’s investment in bioequivalence trials for Corplex Donepezil, as well as the ancillary clinical trials required to support the NDA filing for the product,  in addition to increased expenses associated with feasibility programs for new products. 

 

General and administrative (G&A) expenses were $3.3 million for both the third quarter of fiscal 2018 and for the same period of fiscal 2017, and were $10.7 million for the nine-month period ended June 30, 2018, compared with $9.3 million in the same period in fiscal 2017.  The increase in G&A expenses for the nine months was primarily driven


 

by higher one-time legal and outside services costs in the second quarter,  as well as higher stock-based compensation costs.    

 

Corium reported a net loss of $12.4 million for the third quarter of fiscal 2018, or $0.34 per share, compared with a net loss of $13.4 million, or $0.43 per share, in the same period of fiscal 2017.    For the nine-month period ended June 30, 2018, the net loss was $43.7 million, or $1.21 per share, compared with a net loss of $34.9 million, or $1.30 per share, for the same period in fiscal 2017.  As of June 30, 2018, there were 36,244,074 shares of Corium common stock outstanding.    

 

Cash and cash equivalents as of June 30, 2018 were $82.5 million.

 

Conference Call and Webcast Details

 

Corium will host a conference call today at 5:00 p.m. ET (2:00 p.m. PT) to discuss the financial results for the third fiscal quarter and the nine months ended June 30, 2018.  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 4192359.    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.  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.  For further information, please visit www.coriumintl.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, market and growth opportunities and demand for our commercial products,  financial and operating performance, product pipeline, intellectual property rights and portfolio,  clinical trial and regulatory timing and plans, 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 Annual Report on Form 10-Q for the quarter ended March 31, 2018, filed with the Securities and Exchange Commission (SEC) on May 15, 2018, 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 speak 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.

Twirla® is a registered trademark of Agile Therapeutics, Inc.

 

 

###

 

 

Investor and Media Contact:

SMP Communications

Susan M. Pietropaolo

susan@smpcommunications.com

(201) 923-2049

 

 


 

CORIUM INTERNATIONAL, INC.

CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended June 30,

 

Nine Months Ended June 30,

 

 

    

2018

    

2017

    

2018

    

2017

    

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

 

Product revenues

 

$

5,901

 

$

5,906

 

$

18,512

 

$

16,301

 

Contract research and development revenues

 

 

1,529

 

 

1,936

 

 

7,813

 

 

5,320

 

Other revenues

 

 

240

 

 

267

 

 

720

 

 

801

 

Total revenues

 

 

7,670

 

 

8,109

 

 

27,045

 

 

22,422

 

Costs and operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of product revenues

 

 

3,507

 

 

3,935

 

 

10,806

 

 

10,892

 

Cost of contract research and development revenues

 

 

2,339

 

 

2,977

 

 

9,238

 

 

7,891

 

Research and development expenses

 

 

8,305

 

 

9,122

 

 

30,511

 

 

22,650

 

General and administrative expenses

 

 

3,325

 

 

3,284

 

 

10,728

 

 

9,288

 

Amortization of intangible assets

 

 

183

 

 

159

 

 

541

 

 

514

 

Loss on disposal of equipment

 

 

 4

 

 

 6

 

 

 4

 

 

 6

 

Total costs and operating expenses

 

 

17,663

 

 

19,483

 

 

61,828

 

 

51,241

 

Loss from operations

 

 

(9,993)

 

 

(11,374)

 

 

(34,783)

 

 

(28,819)

 

Interest income

 

 

332

 

 

77

 

 

617

 

 

149

 

Interest expense

 

 

(3,370)

 

 

(2,087)

 

 

(7,903)

 

 

(6,178)

 

Loss on extinguishment of long-term debt

 

 

 —

 

 

 —

 

 

(2,258)

 

 

 —

 

Other income

 

 

640

 

 

 —

 

 

640

 

 

 —

 

Loss before income taxes

 

 

(12,391)

 

 

(13,384)

 

 

(43,687)

 

 

(34,848)

 

Income tax expense

 

 

 —

 

 

 —

 

 

 2

 

 

 2

 

Net loss and comprehensive loss

 

$

(12,391)

 

$

(13,384)

 

$

(43,689)

 

$

(34,850)

 

Net loss per share attributable to common stockholders, basic and diluted

 

$

(0.34)

 

$

(0.43)

 

$

(1.21)

 

$

(1.30)

 

Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted

 

 

36,214,740

 

 

31,457,702

 

 

36,144,746

 

 

26,784,678

 

 


 

CORIUM INTERNATIONAL, INC.

CONDENSED BALANCE SHEETS

(In thousands, except share and per share data)

(Unaudited)

 

 

 

 

 

 

 

 

 

 

As of June 30,

 

As of September 30,

 

 

    

2018

    

2017

    

 

 

 

 

 

 

 

ASSETS

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

82,523

 

$

57,466

 

Accounts receivable

 

 

3,556

 

 

4,641

 

Unbilled accounts receivable

 

 

228

 

 

169

 

Inventories

 

 

1,686

 

 

2,300

 

Prepaid expenses and other current assets

 

 

924

 

 

982

 

Total current assets

 

 

88,917

 

 

65,558

 

Property and equipment, net

 

 

15,810

 

 

12,176

 

Intangible assets, net

 

 

7,404

 

 

7,117

 

TOTAL ASSETS

 

$

112,131

 

$

84,851

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

Accounts payable

 

$

4,519

 

$

3,978

 

Accrued expenses and other current liabilities

 

 

6,860

 

 

6,411

 

Long-term debt, current portion

 

 

49

 

 

13,172

 

Recall liability, current portion

 

 

 119

 

 

114

 

Deferred contract revenues, current portion

 

 

137

 

 

626

 

Total current liabilities

 

 

11,684

 

 

24,301

 

Convertible notes, net

 

 

70,021

 

 

 —

 

Long-term debt, net of current portion

 

 

337

 

 

39,027

 

Recall liability, net of current portion

 

 

1,697

 

 

1,811

 

Deferred contract revenues, net of current portion

 

 

3,500

 

 

3,500

 

Total liabilities

 

 

87,239

 

 

68,639

 

Commitments and contingencies

 

 

 

 

 

 

 

Stockholders’ equity:

 

 

 

 

 

 

 

Common stock

 

 

36

 

 

36

 

Additional paid-in capital

 

 

283,826

 

 

231,457

 

Accumulated deficit

 

 

(258,970)

 

 

(215,281)

 

Total stockholders’ equity

 

 

24,892

 

 

16,212

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

112,131

 

$

84,851