UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington D.C. 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):  May 15, 2017

 

INSMED INCORPORATED

(Exact name of registrant as specified in its charter)

 

Virginia

 

000-30739

 

54-1972729

(State or other jurisdiction of
incorporation)

 

(Commission File Number)

 

(I.R.S. Employer Identification
No.)

 

 

 

 

 

10 Finderne Avenue, Building 10
Bridgewater, New Jersey

 

 

 

08807

(Address of principal executive offices)

 

 

 

(Zip Code)

 

Registrant’s telephone number, including area code: ( 908) 977-9900

 

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))

 

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 o

 

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.  o

 

 

 



 

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

 

Chief Financial Officer Appointment

 

On May 15, 2017, Insmed Incorporated (the “Company”) announced that Mr. Paolo Tombesi had been appointed as Chief Financial Officer, to be effective June 1, 2017.  Prior to joining the Company, Mr. Tombesi, 54, was Vice President and Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation, a position he held since November 2014.  Mr. Tombesi was Managing Director and Chief Financial Officer of Novartis Japan from April 2009 to October 2014.  From September 2006 to March 2009, Mr. Tombesi held various finance roles at Novartis.  Prior to his time at Novartis, Mr. Tombesi held several finance director positions at Bristol-Myers Squibb from August 1996 to September 2006.  From January 1988 to July 1996, Mr. Tombesi held various positions in consumer goods at Unilever NV and Johnson & Johnson.  Mr. Tombesi holds a B.Ed. in Business and Managerial Economics from Sapienza Università di Roma and a B.A. in Accounting from Duca degli Abruzzi Roma.

 

Pursuant to the terms of the Company’s employment agreement with Mr. Tombesi, he will receive an initial annual base salary of $435,000 and will be eligible to participate in the Company’s benefit and compensation plans.  Mr. Tombesi has been assigned an initial annual target bonus of 40% of his base salary.  He will also receive a signing bonus of $40,000 upon the completion of 30 days of employment.  The Company will reimburse Mr. Tombesi for reasonable attorneys’ fees incurred by him in connection with entering into the employment agreement, up to a maximum of $5,000. Mr. Tombesi will also receive an option to purchase shares of the Company’s common stock having an aggregate value of $1,300,000.  The number of shares underlying the option will be determined using a Black-Scholes calculation based upon the closing price of the Company’s common stock on the Nasdaq Global Select Market on June 1, 2017. The option award agreement will be consistent with the Company’s standard stock option inducement award agreement, and the option will vest on a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the date of grant and 12.5% of the shares subject to the option vesting every six months thereafter through the fourth anniversary of the date of grant, subject to Mr. Tombesi’s continued employment with the Company on each vesting date.

 

Mr. Tombesi’s employment agreement provides for payment of the following upon his death or disability: (i) a pro-rata portion of his annual bonus based on actual performance during the year of the qualifying termination, (ii) any unpaid bonus for a fiscal year ending on or prior to the date of the qualifying termination, and (iii) any insurance benefits to which he and his beneficiaries are entitled as a result of his death or disability.  If Mr. Tombesi’s employment is terminated by the Company without cause or by him for good reason (such a termination, a “qualifying termination”), in either case, within one year after a change in control, Mr. Tombesi will receive (i) a lump sum severance payment equal to his annual base salary, (ii) a pro-rata portion of his annual bonus based on actual performance during the year of the qualifying termination, (iii) any unpaid bonus for a fiscal year ending on or prior to the date of the qualifying termination, (iv) full vesting of time-based equity awards and (v) reimbursement for up to one year of continued health and dental benefits. In the event of a qualifying termination prior to a change in control or more than one year thereafter, Mr. Tombesi would be eligible for similar benefits, although his severance would be payable ratably over 12 months and any accelerated equity award vesting would be limited to stock options that would otherwise have vested within six months.

 

There are no arrangements or understandings between Mr. Tombesi and any other person pursuant to which he was selected as an officer, and there are no family relationships between Mr. Tombesi and any of the Company’s directors or executive officers. Mr. Tombesi has no direct or indirect material interest in any existing or currently proposed transaction that would require disclosure under Item 404(a) of Regulation S-K.

 

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Chief Medical Officer Transition

 

On May 15, 2017, the Company also announced that Dr. Paul D. Streck had been appointed as Chief Medical Officer, to be effective June 5, 2017 and that Dr. Eugene Sullivan, the Company’s current Chief Medical and Scientific Officer, would leave that position to serve in the newly created role of Chief Product Strategy Officer, effective on the same date.  Prior to joining the Company, Dr. Streck, 54, was Vice President, Global Medical Specialty Franchise, Immuno-Inflammation at GlaxoSmithKline plc, a position he held since November 2015.  From November 2007 to November 2015, Dr. Streck held various positions at Shire Pharmaceuticals (“Shire”).  Dr. Streck served as Group Vice President, Clinical Development/TA Lead (Hematology, Gastrointestinal, Internal Medicine) at Shire from November 2013 to November 2015.  Prior to that, Dr. Streck served as Global Head of Medical Affairs, Internal Medicine (November 2012 to December 2013), Product General Manager, Emerging Business Unit (November 2011 to November 2012), and Senior Director, Global Clinical Development (November 2007 to December 2012).  From February 2006 to October 2007, Dr. Streck was Director of Marketing at AMGEN USA Inc. Dr. Streck holds a M.B.A. from the Duke University Fuqua School of Business, a M.D. from Jefferson Medical College, a D.M.D. from the Temple University School of Dentistry and a B.A. in chemistry from Rutgers University.

 

Pursuant to the terms of the Company’s employment agreement with Dr. Streck, he will receive an initial annual base salary of $425,000 and will be eligible to participate in the Company’s benefit and compensation plans and to receive relocation benefits.  Dr. Streck has been assigned an initial annual target bonus of 40% of his base salary.  He will also receive a signing bonus of $40,000 upon the completion of 30 days of employment.  The Company has further agreed to reimburse Dr. Streck for certain other fees and expenses incurred by him in connection with entering into the employment agreement and joining the Company, up to a maximum of $50,000. In addition, Dr. Streck will receive an option to purchase shares of the Company’s common stock having an aggregate value of $1,100,000.  The number of shares underlying the option will be determined using a Black-Scholes calculation based upon the closing price of the Company’s common stock on the Nasdaq Global Select Market on June 5, 2017. The option award agreement will be consistent with the Company’s standard stock option inducement award agreement, and the option will vest on a four-year vesting schedule, with 25% of the shares subject to the option vesting on the first anniversary of the date of grant and 12.5% of the shares subject to the option vesting every six months thereafter through the fourth anniversary of the date of grant, subject to Dr. Streck’s continued employment with the Company on each vesting date.

 

Dr. Streck’s employment agreement provides for payment of benefits similar to those payable to Mr. Tombesi upon Dr. Streck’s death or disability or in connection with a qualifying termination of Dr. Streck’s employment, whether prior to or following a change in control.

 

There are no arrangements or understandings between Dr. Streck and any other person pursuant to which he was selected as an officer, and there are no family relationships between Dr. Streck and any of the Company’s directors or executive officers. Dr. Streck has no direct or indirect material interest in any existing or currently proposed transaction that would require disclosure under Item 404(a) of Regulation S-K.

 

ITEM 7.01 — Regulation FD Disclosure.

 

On May 15, 2017, the Company issued a press release announcing the appointments of Mr. Tombesi as Chief Financial Officer and Dr. Streck as Chief Medical Officer and Dr. Sullivan’s transition to Chief

 

2



 

Product Strategy Officer.  The press release is attached hereto as Exhibit 99.1 and incorporated in this Item 7.01 by reference.

 

ITEM 9.01 - Financial Statements and Exhibits.

 

(d)  Exhibits

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press release issued by Insmed Incorporated on May 15, 2017.

 

3



 

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.

 

Dated: May 19, 2017

INSMED INCORPORATED

 

 

 

By:

/s/ Christine Pellizzari

 

Name:

Christine Pellizzari

 

Title:

General Counsel and Corporate Secretary

 

4



 

EXHIBIT INDEX

 

Exhibit
No.

 

Description

 

 

 

99.1

 

Press release issued by Insmed Incorporated on May 15, 2017.

 

5


Exhibit 99.1

 

 

Insmed Announces Key Additions to its Executive Management Team

 

— Paolo Tombesi named as Chief Financial Officer —
— Paul Streck, M.D., appointed as Chief Medical Officer —
— Eugene Sullivan, M.D., assumes role of Chief Product Strategy Officer —

 

Bridgewater, N.J., May 15, 2017 (GLOBE NEWSWIRE) — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today announced the appointment of Paolo Tombesi as Chief Financial Officer, effective June 1, 2017, and Paul Streck, M.D., as Chief Medical Officer, effective June 5, 2017. Additionally, Eugene Sullivan, M.D., has been appointed to the newly created role of Chief Product Strategy Officer.

 

“These management changes will strengthen our already solid leadership team and add critical skills to our organization as we collectively advance the clinical development of our portfolio and prepare for the potential commercialization of liposomal amikacin for inhalation,” said Will Lewis, president and chief executive officer of Insmed.

 

Mr. Tombesi brings over 20 years of experience in the biotechnology and pharmaceutical sector, most recently serving as Vice President and Chief Financial and Administrative Officer of Novartis Pharmaceuticals Corporation. In addition, Mr. Tombesi was also a member of Novartis’s Pharma Executive Committee, Commercial Leadership Team, Corporate Compliance Committee, Global Pharma Finance Leadership Team and Global Country CFO Team. He joined Novartis in 2006 as Head of Finance Region Europe, Oncology, and held several positions of increasing responsibility, including serving as Managing Director and CFO of Novartis Japan. Prior to joining Novartis, Mr. Tombesi held various financial positions with Bristol-Myers Squibb. His career began in consumer goods with Unilever NV and Johnson & Johnson. He holds a degree in business and managerial ecomonics from Rome’s La Sapienza University and a degree in accounting from Duca degli Abruzzi Roma.

 

Dr. Streck joins Insmed with over 25 years of clinical development, management and leadership expertise. He most recently served as Vice President, Global Medical Specialty Franchise, Immuno-inflammation at GlaxoSmithKline where he was responsible for portfolio strategy, including drug launch, life cycle management, post-registration clinical strategy and health economics. Previously, he held various positions with functions ranging from clinical development to medical affairs to commercial with Shire Pharmaceuticals and AMGEN USA, Inc.

 



 

Dr. Streck also practiced in the Jefferson Health System at Thomas Jefferson University. He received his medical degree from Jefferson Medical College and was a resident in oral and maxillofacial surgery at Thomas Jefferson University Hospital. Dr. Streck also holds a doctorate of dental medicine from Temple University School of Denistry, a Masters of Business Administration from the Duke University Fuqua School of Business and board certification in oral and maxillofacial surgery from the American Board of Oral and Maxillofacial Surgery.

 

Dr. Sullivan joined Insmed as Chief Medical and Scientific Officer in 2015, and has more than 20 years of experience with a focus on pulmonary and orphan diseases. Prior to joining Insmed, and in addition to other roles within the industry, Dr. Sullivan held several positions at the U.S. Food and Drug Administration. Dr. Sullivan’s extensive product strategy development experience uniquely qualifies him for the newly-created position as he will be tasked with overseeing the advancement of Insmed’s product pipeline.

 

“Paolo’s extensive financial and commercial understanding of the pharmaceutical industry will assist us in addressing the challenges faced by rapidly growing, global businesses. Paul brings proven management and leadership skills that are critical to us as a multi-product development organization. Paul has played a crucial role in the clinical development, launch or commercial marketing of more than 25 medications across a broad range of indications, including rare and orphan diseases. In his new role, Gene will continue to rely on his broad clinical and regulatory background and will focus his directly relevant experience with the FDA and demonstrated product strategy expertise on the development of our ongoing portfolio strategy,” added Mr. Lewis.

 

About Insmed

 

Insmed Incorporated is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The company is advancing a global phase 3 clinical study of ARIKAYCE® (liposomal amikacin for inhalation) for adult patients with treatment refractorynontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC), which is a rare and often chronic infection that is capable of causing irreversible lung damage and can be fatal. There are currently no approved inhaled products specifically indicated for the treatment of refractory NTM lung disease caused by MAC in the United States or the European Union. Insmed’s earlier-stage clinical pipeline includes INS1007, a novel oral reversible inhibitor of DPP1 with therapeutic potential in non-cystic fibrosis bronchiectasis, and INS1009, an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension. For more information, visit www.insmed.com.

 

“Insmed” and “ARIKAYCE” are the company’s trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.

 



 

Forward-looking statements

 

This press release contains forward looking statements.  “Forward-looking statements,” as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties.  Words herein such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “intends,” “potential,” “continues,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) may identify forward-looking statements.

 

The forward-looking statements in this press release are based upon the company’s current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause the company’s actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others: uncertainties in the research and development of our existing product candidates, including due to delays in patient enrollment or failure of our preclinical studies or clinical trials to satisfy pre-established endpoints; failure to develop, or to license for development, additional product candidates, including a failure to attract experienced third party collaborators; failure to obtain, or delays in obtaining, regulatory approval from the United States Food and Drug Administration, the European Medicines Agency, and other regulatory authorities for our product candidates or their delivery devices, including due to insufficient clinical data or selection of endpoints that are not satisfactory to regulators; failure of third parties on which we are dependent to conduct our clinical trials and to manufacture sufficient quantities of our product candidates for clinical or commercial needs; failure to comply with license agreements that are critical for our product development, including our license agreements with PARI Pharma GmbH and AstraZeneca AB; lack of safety and efficacy of our product candidates; inaccuracies in our estimate of the size of the potential markets for our product candidates; failure to maintain regulatory approval for our product candidates, once received, due to a failure to satisfy post-approval regulatory requirements, such as the need for post-clinical trials; uncertainties in the rate and degree of market acceptance of product candidates, if approved; uncertainties in the timing, scope and rate of reimbursement for our product candidates; competitive developments affecting our product candidates; inaccurate estimates regarding our future capital requirements, including those necessary to fund milestone payments or royalties owed to third parties; inability to repay our existing indebtedness or to obtain additional financing when needed; failure to obtain, protect and enforce our patents and other intellectual property; inability to create an effective direct sales and marketing infrastructure or to partner with a third party that offers such an infrastructure for distribution of our product candidates; the cost and potential reputational damage resulting from litigation to which we are a party, including, without limitation, the class action lawsuit pending against us; failure to comply with the laws and regulations that impact our business; loss of key personnel; and changes in laws and regulations applicable to our business, including those related to pricing and reimbursement of our product candidates.  For additional

 



 

information about the risks and uncertainties that may affect our business, please see the factors discussed in Item 1A, “Risk Factors,” in the company’s Annual Report on Form 10-K for the year ended December 31, 2016.

 

The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date of this press release. The company disclaims any obligation, except as specifically required by law and the rules of the Securities and Exchange Commission, to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.

 

Investor Contact:

 

Laura Perry or Heather Savelle
Argot Partners
212.600.1902
laura@argotpartners.com

 

heather@argotpartners.com