Current Report Filing (8-k)

OTONOMY, INC.

Date: September 1, 2015

/s/ Eric Loumeau

Eric Loumeau

General Counsel and Chief Compliance Officer

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 27, 2015

Otonomy, Inc.

(Exact name of registrant as specified in its charter)

Delaware

001-36591

26-2590070

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer
Identification No.)

6275 Nancy Ridge Drive, Suite 100

San Diego, CA 92121

(Address of principal executive offices, including zip code)

(858) 242-5200

(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))

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Resignation of Director

On August 27, 2015, Peter Bisgaard resigned as Chairman and member of the Board of Directors (the “Board”) of Otonomy, Inc. (the “Company”). The decision of Mr. Bisgaard to resign is not the result of any disagreement with the Company on any matter relating to its operations, policies or practices. The Company greatly appreciates the contributions Mr. Bisgaard has made to Otonomy.

On August 27, 2015, the Board appointed Jay Lichter, Ph.D. as Chairman of the Board to replace Mr. Bisgaard.

Election of Director

On August 28, 2015, the Board appointed Theodore R. Schroeder to the Board, filling the vacancy created as a result of Mr. Bisgaard’s resignation. Mr. Schroder will serve as a Class II director, with a term expiring at the Company’s 2016 annual meeting of stockholders. It is expected that Mr. Schroeder will be appointed to the corporate governance and nominating committee of the Board.

Mr. Schroeder currently serves as President, Chief Executive Officer and as a member of the board of directors of Zavante Therapeutics, Inc., a private biopharmaceutical company. Mr. Schroeder co-founded Cadence Pharmaceuticals, Inc., a formerly-public pharmaceutical company, and served as its President and Chief Executive Officer, and as a member of the board of directors, from May 2004 until its acquisition in May 2014 by Mallinckrodt Pharmaceuticals, Inc. From August 2002 to February 2004, Mr. Schroeder served as Senior Vice President, North American Sales and Marketing, of Elan Pharmaceuticals, Inc., a neuroscience-based pharmaceutical company, and from February 2001 to August 2002, as General Manager of the Hospital Products Business Unit. From May 1999 until its acquisition by Elan Pharmaceuticals, Inc. in November 2000, Mr. Schroeder served as Senior Director of Marketing Hospital Products at Dura Pharmaceuticals, Inc., a specialty respiratory pharmaceutical and pulmonary drug delivery company. Prior to joining Dura Pharmaceuticals, Inc., Mr. Schroeder held a number of hospital-related sales and marketing positions with Bristol-Myers Squibb Company, a global pharmaceutical company. Mr. Schroeder currently serves on the board of directors of Cidara Therapeutics, Inc, a public biotechnology company. From August 2011 until its acquisition by Horizon Pharma, Inc. in May 2015, Mr. Schroeder served on the board of directors of Hyperion Therapeutics, Inc., a formerly-public company focused on treating ultra-rare diseases. From December 2009 until its acquisition by Cubist Pharmaceuticals, Inc. in September 2013, he served on the board of directors of Trius Therapeutics, Inc., a formerly-public biopharmaceutical company. Mr. Schroeder also currently serves on the board of directors of Sharp HealthCare Foundation, a non-profit philanthropic organization, and Biocom, a regional life science trade association, where he is Chairman and a member of the executive committee. Mr. Schroeder holds a Bachelor’s degree in management from Rutgers University.

In accordance with Company policy, Mr. Schroeder will receive annual cash compensation of $35,000 for his services as a member of the Board and an additional $3,750 per year for service as a corporate governance and nominating committee member, each payable quarterly in arrears on a pro-rata basis, and on August 28, 2015, Mr. Schroeder was automatically granted an option to purchase 25,000 shares of common stock, which shall vest as to one-third of the shares subject thereto on each anniversary of the award’s grant date, provided that he remains a service provider through the applicable vesting date.

Beginning with the Company’s annual meeting of stockholders in 2016, Mr. Schroeder will be eligible for equity awards on the same terms as other continuing non-employee members of the Board. Currently, Company policy provides that on the date of each annual meeting of stockholders, each non-employee director who has been a director for three months or more on the date of the annual meeting will automatically be granted an option to purchase 15,000 shares of common stock. Each annual option award will vest fully on the date of the next annual meeting of stockholders held after the date of grant, provided that such director remains a service provider through the applicable vesting date. The Company will also reimburse Mr. Schroeder for all expenses associated with attending meetings of the Board and committees.

Mr. Schroeder also executed the Company’s standard form of indemnification agreement, a copy of which has been filed as Exhibit 10.1 to the Company’s Amendment No. 2 to Registration Statement on Form S-1 (File No. 333-197365) filed with the Securities and Exchange Commission on August 1, 2014 and is incorporated herein in its entirety by reference.

There is no arrangement or understanding between Mr. Schroeder and any other persons pursuant to which Mr. Schroeder was elected as a director. In addition, Mr. Schroder is not a party to any transaction, or series of transactions, required to be disclosed pursuant to Item 404(a) of Regulation S-K.

On September 1, 2015, the Company issued a press release announcing Mr. Schroeder’s appointment as a director. The press release is attached hereto as Exhibit 99.1.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits


Exhibit No.		Description

99.1		Press Release dated September 1, 2015.

SIGNATURES

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

EXHIBIT INDEX


Exhibit No.		Description

99.1		Press Release dated September 1, 2015.

Exhibit 99.1

LOGO

FOR IMMEDIATE RELEASE

Otonomy Appoints Ted Schroeder to Board of Directors

SAN DIEGO, Sept. 1, 2015 – Otonomy, Inc. (Nasdaq: OTIC), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear, today announced the appointment of Ted Schroeder to its board of directors. Most recently, Mr. Schroeder led specialty pharmaceutical company Cadence Pharmaceuticals from its founding until its acquisition by Mallinckrodt Pharmaceuticals for $1.4 billion in 2014.

“Ted has strong credentials in hospital-based pharmaceutical sales and marketing that are highly relevant as we move toward the commercialization of AuriPro™ in the United States in the first quarter of 2016,” said David A. Weber, Ph.D., president and CEO of Otonomy. “Furthermore, his experience as both a public company CEO and board member will provide helpful perspective as we transition to a commercial company with an expanding product pipeline.”

Mr. Schroeder co-founded Cadence Pharmaceuticals in 2004 and served as president, CEO and member of the board of directors until the company’s acquisition by Mallinckrodt Pharmaceuticals in 2014 for $1.4 billion. Under his leadership, Cadence raised in excess of $400 million from private and public investors including completion of a successful IPO, and established a strong hospital-based sales and marketing presence in support of its acute care product. Prior to co-founding Cadence he held several roles at Elan Pharmaceuticals including senior vice president of North America sales and marketing and vice president and general manager of the Hospital Products Business Unit, a role he also held at Dura Pharmaceuticals before its acquisition by Elan. Prior to joining Dura, Mr. Schroeder held a number of hospital-related sales and marketing positions with Bristol-Myers Squibb.

Mr. Schroeder currently serves on the board of Cidara Therapeutics (Nasdaq: CDTX) and previously served on the boards of Hyperion Therapeutics, Incline Therapeutics and Trius Therapeutics until their respective acquisitions. Mr. Schroeder is a member of the Sharp Hospital Foundation board and chair of the BIOCOM board of directors. He holds a bachelor’s degree in management from Rutgers University. In 2014, Mr. Schroeder was named the EY Entrepreneur of the Year for the San Diego region and was named a national EOY finalist that same year.

In addition, Otonomy announced that Peter Bisgaard, partner of Novo Ventures, resigned as Otonomy’s chairman and member of its board of directors. Jay Lichter, Ph.D., co-founder of Otonomy and current board member, has been appointed as the new chairman.

“It has been a pleasure working with Mr. Bisgaard for the past five years, and I thank him for the valuable guidance and support he provided Otonomy as our pipeline matured and throughout our transition to a public company,” added Dr. Weber. “I look forward to continuing to work with Dr. Lichter who brings a unique and valuable perspective as both a Ménière’s patient and company co-founder.”

About Otonomy

Otonomy is a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapeutics for diseases and disorders of the ear. Otonomy’s proprietary technology provides sustained exposure of drugs to the ear following a single administration. Otonomy has three product candidates in development. AuriPro™ is an antibiotic that has completed Phase 3 clinical trials in pediatric patients with middle ear effusion at the time of tympanostomy tube placement surgery, and the FDA has assigned a PDUFA action date of December 25, 2015 for the company’s New Drug Application. OTO-104 is a steroid that has recently completed a Phase 2b clinical trial in 154 patients with Ménière’s disease. Based on these results, Otonomy intends to initiate two parallel Phase 3 trials for OTO-104 in Ménière’s disease patients with at least one trial initiated by the end of 2015. OTO-311 is an NMDA receptor antagonist in development as a treatment for tinnitus. For additional information please visit www.otonomy.com.

Cautionary Note Regarding Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or Otonomy’s future financial or operating performance. Forward-looking statements in this press release include, but are not limited to, Otonomy’s expectations regarding the commercial launch of AuriPro in the United States, Otonomy’s transition to a commercial company with an expanding product pipeline, and the initiation and timing of two parallel Phase 3 trials for OTO-104. Otonomy’s expectations regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties. Actual results may differ materially from those indicated by these forward-looking statements as a result of these risks and uncertainties, including but not limited to: Otonomy’s limited operating history and its expectation that it will incur significant losses for the foreseeable future; Otonomy’s ability to obtain substantial additional financing; Otonomy’s dependence on the regulatory and commercial success of AuriPro and OTO-104 and advancing additional product candidates, such as OTO-311; the uncertainties inherent in the clinical drug development process, including, without limitation, Otonomy’s ability to adequately demonstrate the safety and efficacy of its product candidates, the preclinical and clinical results for its product candidates, which may not support further development of product candidates, and challenges related to patient enrollment in clinical trials; Otonomy’s ability to obtain regulatory approval for its product candidates; side effects or adverse events associated with Otonomy’s product candidates; competition in the biopharmaceutical industry; Otonomy’s dependence on third parties to conduct preclinical studies and clinical trials; Otonomy’s dependence on third parties for the manufacture of products; Otonomy’s dependence on a small number of suppliers for raw materials; Otonomy’s ability to protect its intellectual property related to product candidates in the United States and throughout the world; expectations regarding potential market size, opportunity and growth; Otonomy’s ability to manage operating expenses; implementation of Otonomy’s business model and strategic plans for its business, products and technology; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled “Risk Factors” in Otonomy’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on August 12, 2015, and Otonomy’s future reports to be filed with the SEC. The forward-looking statements in this press release are based on information available to Otonomy as of the date hereof. Otonomy disclaims any obligation to update any forward-looking statements, except as required by law.

Contacts:

Media Inquiries

Canale Communications

Heidi Chokeir, Ph.D.

Vice President

619.849.5377

heidi@canalecomm.com

Investor Inquiries

Westwicke Partners

Robert H. Uhl

Managing Director

858.356.5932