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 12, 2014
Corium International, Inc.
(Exact name of registrant as specified in its charter)
Delaware |
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001-36375 |
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38-3230774 |
(State or other jurisdiction of |
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(Commission File Number) |
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(I.R.S. Employer |
235 Constitution Drive, |
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94025 |
(Address of Principal Executive Offices) |
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(Zip Code) |
(650) 298-8255
(Registrants 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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations and Financial Condition.
On August 12, 2014, Corium International, Inc. (the Company) issued a press release to announce its financial results for its third quarter ended June 30, 2014. 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 |
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Description |
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99.1 |
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Press release dated August 12, 2014. |
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.
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CORIUM INTERNATIONAL, INC. | |
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Date: August 12, 2014 |
By: |
/s/ Robert Breuil |
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Robert Breuil |
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Chief Financial Officer |
Exhibit 99.1
CORIUM REPORTS THIRD FISCAL QUARTER 2014 FINANCIAL RESULTS
MENLO PARK, Calif., August 12, 2014 Corium International, Inc. (NASDAQ: CORI), a commercial-stage biopharmaceutical company focused on the development, manufacture and commercialization of specialty transdermal products, today announced unaudited results from operations for both the third fiscal quarter and the nine months ended June 30, 2014. Coriums fiscal year ends on September 30, 2014.
We have continued to invest in our proprietary pipeline, and we are especially pleased with our progress in advancing several product candidates for Alzheimers and Parkinsons diseases, said Peter Staple, Chief Executive Officer of Corium. Our R&D team has applied Coriums innovative transdermal technologies to develop lead formulations of three approved drugs with the potential to provide significantly improved treatments for patients living with these debilitating diseases. We are encouraged by the results of this work, and have initiated preclinical testing to determine the optimal formulations for human clinical trials. We anticipate that one or more of these programs will be ready to enter into Phase 1 pharmacokinetic studies in the first half of 2015.
Corium reported total revenues in the third fiscal quarter of 2014 of $10.2 million, compared with $12.6 million of total revenues in the third fiscal quarter of 2013. The reduction in total revenues in the third fiscal quarter of 2014 primarily reflects the anticipated declines in full-year product revenues from both Clonidine TDS (marketed by Teva Pharmaceuticals) and Fentanyl TDS (marketed by Par Pharmaceutical), as well as reductions in contract research and development revenues from programs that have reached the final stages of process development, partially offset by an increase in sales of Crest Whitestrips to P&G and an increase in contract research and development revenues from new co-development programs as well as partner-funded programs.
Total research and development (R&D) expenses in the third fiscal quarter of 2014 were $5.4 million, compared with $4.2 million of total R&D expense in the third fiscal quarter of 2013. The increase in total R&D expense in the third fiscal quarter of 2014 primarily reflects the addition of new development programs with partners, as compared with the prior period, including Coriums increased investment in its proprietary programs and two co-development programs.
General and administrative (G&A) expenses in the third fiscal quarter of 2014 were $3.5 million, compared with $1.5 million of G&A expense in the third fiscal quarter of 2013. The increase in G&A expense in the third fiscal quarter of 2014 was primarily attributable to higher expenses due to timing of incentive compensation, stock-based compensation and increased activities associated with becoming a public company.
Corium reported a net loss for the third fiscal quarter of 2014 of $5.0 million, or $0.28 per share on a fully-diluted basis, compared with a net loss of $9.2 million, or $4.12 per share, in the third fiscal quarter of 2013. As a result of Coriums IPO on April 2, 2014, the fair value of an embedded derivative in a subordinated note was determined to be zero as of March 31, 2013 and thereafter. The fair value of this embedded derivative significantly increased in the third fiscal quarter of 2013, resulting in a non-cash, non-recurring charge of $8.0 million in that same quarter. Without the effect of this charge, Corium would have recognized a non-GAAP net loss for the third fiscal quarter of 2013 of $1.2 million.
Cash, cash equivalents and available-for-sale securities at the quarter ended June 30, 2014 were $44.2 million.
Conference Call and Webcast Details
Corium will host a conference call today at 5 p.m. EDT to discuss the financial results for the third fiscal quarter and first nine months of fiscal 2014. Investors and analysts can access the call toll-free by dialing 844-831-3024 (United States) or +1 315-625-6887 (international). No passcode is required for this call. The conference call will also be available via a live audio webcast on the Investors section of Coriums 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# 83938847 or by visiting Coriums website.
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 companys 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 Pharmaceuticals 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 companys late-stage pipeline includes a contraceptive patch currently in Phase 3 trials co-developed with Agile Therapeutics and additional transdermal products co-developed with Teva. Corium has two internal pipeline programs in earlier stage clinical development for the treatment of osteoporosis and benign prostatic hyperplasia. For further information, please visit www.coriumgroup.com.
Statement regarding use of non-GAAP financial measures
The company reported non-GAAP net loss in this release in addition to, and not as a substitute for, or superior to, net loss and net loss per share calculated in accordance with GAAP.
Management believes the presentation of net loss and net loss per share that excludes the non-cash, non-recurring gain from the change in fair value of an embedded derivative provides useful supplemental information to investors and facilitates the analysis of the companys core operating results and comparison of net loss and net loss per share across reporting periods. Management also believes that this supplemental non-GAAP information is therefore useful to investors in analyzing and assessing the companys past and future operating performance.
The company encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP information and the reconciliation between these presentations, to more fully understand its business.
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 managements current expectations and projections and are subject to risks and uncertainties, which may cause Coriums actual results to differ materially from the statements contained herein. Further information on potential risk factors that could affect Coriums business and its financial results are detailed in the final prospectus for our initial public offering, dated as of April 2, 2014, and filed with the Securities and Exchange Commission pursuant to Rule 424(b)(4) on April 3, 2014 (File No. 333-194279), Coriums most recent Form 10-Q filed with the Securities and Exchange Commission on May 14, 2014, 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.
Company Contact:
Robert S. Breuil
Chief Financial Officer
ir@coriumintl.com
Investor and Media Contact:
Karen L. Bergman
BCC Partners
kbergman@bccpartners.com
650-575-1509
Financial tables follow:
Corium International, Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
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Three Months |
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Nine Months |
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2014 |
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2013 |
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2014 |
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2013 |
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Revenues: |
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Product revenues |
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$ |
7,856 |
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$ |
9,732 |
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$ |
23,196 |
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$ |
29,922 |
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Contract research and development revenues |
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2,023 |
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2,530 |
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7,260 |
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7,292 |
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Other revenues |
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304 |
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304 |
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912 |
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512 |
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Total revenues |
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10,183 |
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12,566 |
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31,368 |
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37,726 |
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Costs and operating expenses: |
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Cost of product revenues |
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4,566 |
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6,080 |
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14,793 |
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18,896 |
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Cost of contract research and development revenues |
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3,789 |
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2,767 |
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11,237 |
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8,709 |
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Research and development expenses |
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1,614 |
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1,393 |
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3,742 |
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3,965 |
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General and administrative expenses |
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3,497 |
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1,463 |
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6,543 |
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4,861 |
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Amortization of intangible assets |
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138 |
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138 |
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399 |
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402 |
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Gain on disposal and sale and leaseback of equipment |
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(24 |
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(46 |
) |
(93 |
) |
(137 |
) | ||||
Total costs and operating expenses |
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13,580 |
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11,795 |
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36,621 |
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36,696 |
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Income (loss) from operations |
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(3,397 |
) |
771 |
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(5,253 |
) |
1,030 |
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Interest income |
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2 |
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2 |
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5 |
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7 |
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Interest expense |
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(1,586 |
) |
(1,982 |
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(5,390 |
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(5,678 |
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Change in fair value of preferred stock warrant liability |
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(274 |
) |
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Change in fair value of subordinated note embedded derivative liability |
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(7,954 |
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7,367 |
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(7,954 |
) | ||||
Loss before income taxes |
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(4,981 |
) |
(9,163 |
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(3,545 |
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(12,595 |
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Income tax benefit |
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Net loss and comprehensive loss |
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$ |
(4,981 |
) |
$ |
(9,163 |
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$ |
(3,545 |
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$ |
(12,595 |
) |
Net loss per share attributable to common stockholders, basic and diluted |
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$ |
(0.28 |
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$ |
(4.12 |
) |
$ |
(0.48 |
) |
$ |
(5.69 |
) |
Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted |
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17,624,327 |
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2,226,451 |
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7,362,142 |
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2,213,513 |
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Corium International, Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
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As of |
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As of |
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(Unaudited) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
44,245 |
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$ |
13,581 |
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Accounts receivable |
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4,503 |
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3,129 |
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Unbilled accounts receivable |
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1,800 |
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1,495 |
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Inventories, net |
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3,115 |
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4,508 |
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Prepaid expenses and other current assets |
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1,329 |
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1,038 |
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Total current assets |
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54,992 |
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23,751 |
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Property and equipment, net |
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12,512 |
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12,622 |
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Debt financing costs, net |
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645 |
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902 |
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Intangible assets, net |
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6,757 |
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6,647 |
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Notes receivable related parties |
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|
|
100 |
| ||
TOTAL ASSETS |
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$ |
74,906 |
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$ |
44,022 |
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LIABILITIES, CONVERTIBLE PREFERRED STOCK, REDEEMABLE COMMON STOCK AND STOCKHOLDERS DEFICIT |
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Current liabilities: |
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Accounts payable |
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$ |
2,573 |
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$ |
2,748 |
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Accrued expenses and other current liabilities |
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3,859 |
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3,374 |
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Bank line of credit |
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1,500 |
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3,873 |
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Long-term debt, current portion |
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113 |
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457 |
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Capital lease obligations, current portion |
|
813 |
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1,029 |
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Preferred stock warrant liability |
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|
|
560 |
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Recall liability, current portion |
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732 |
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1,004 |
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Deferred contract revenues, current portion |
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2,251 |
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2,112 |
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Total current liabilities |
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11,841 |
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15,157 |
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Long-term interest payable |
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11,590 |
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Long-term debt, net of current portion |
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37,824 |
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36,956 |
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Convertible notes |
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9,399 |
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Subordinated note |
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13,000 |
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Subordinated note embedded derivative liability |
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7,367 |
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Capital lease obligations, net of current portion |
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1,084 |
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1,652 |
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Recall liability, net of current portion |
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3,185 |
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3,828 |
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Deferred contract revenues, net of current portion |
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3,500 |
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3,688 |
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Total liabilities |
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$ |
57,434 |
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$ |
102,637 |
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Convertible preferred stock |
|
|
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57,261 |
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Redeemable common stock |
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|
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3,224 |
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Stockholders equity (deficit): |
|
|
|
|
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Common stock |
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18 |
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2 |
| ||
Additional paid-in capital |
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113,422 |
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(26,679 |
) | ||
Accumulated deficit |
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(95,968 |
) |
(92,423 |
) | ||
Total stockholders equity (deficit) |
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17,472 |
|
(119,100 |
) | ||
TOTAL LIABILITIES, CONVERTIBLE PREFERRED AND REEDEMABLE COMMON STOCK AND STOCKHOLDERS DEFICIT |
|
$ |
74,906 |
|
$ |
44,022 |
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