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 23, 2022

INSMED INCORPORATED
(Exact name of registrant as specified in its charter)

Virginia
  
000-30739
  
54-1972729
(State or other jurisdiction
  
(Commission
  
(IRS Employer
of incorporation)
  
File Number)
  
Identification No.)

700 US Highway 202/206
Bridgewater, New Jersey
  
08807
(Zip Code)
(Address of principal executive offices)
    

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):

☐
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))

Securities registered pursuant to Section 12(b) of the Act:
 
Title of each class
Trading Symbol(s)
Name of each exchange on which registered
Common Stock, par value $0.01 per share
INSM
Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR 230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR 240.12b-2).

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

Chief Commercial Officer Appointment

On May 23, 2022, Insmed Incorporated (the “Company”) announced that Mr. Drayton Wise has been appointed as Chief Commercial Officer of the Company, effective immediately. Prior to his appointment, Mr. Wise, 47, served as the Company’s Senior Vice President, Head of US & General Manager, ARIKAYCE, a position he held since November 2019. From October 2016 to November 2019, Mr. Wise served as the Company’s Vice President, General Manager – ALIS. Prior to that, Mr. Wise held various other roles at the Company, including Vice President, Marketing & Sales (October 2015 to October 2016), Senior Director, Global Marketing & Commercial Operations (October 2014 to October 2015) and Senior Director, Global Commercial Operations (February 2014 to October 2014). Prior to joining the Company, Mr. Wise held various sales and commercial roles at Novartis from 1999 to 2014.

Pursuant to the terms of the Company’s employment agreement with Mr. Wise, he will receive an annual base salary of $500,000 and will be eligible to participate in the Company’s benefit and compensation plans. Mr. Wise has been assigned an annual target bonus of 40% of his base salary. Mr. Wise will also receive an award of restricted stock units and an option to purchase shares of the Company’s common stock having an aggregate value of $2,100,000. The restricted stock unit award agreement will be consistent with the Company’s standard restricted stock unit award agreement, and the restricted stock units will vest on a four-year vesting schedule, with 25% vesting on each of the first, second, third and fourth anniversaries of the grant date, subject to Mr. Wise’s continued employment with the Company on each vesting date. 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 May 23, 2022. The option award agreement will be consistent with the Company’s standard stock option 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. Wise’s continued employment with the Company on each vesting date.

Mr. Wise’s employment agreement provides for payment of the following upon his death or disability: (i) any accrued obligations, (ii) a pro-rata portion of his annual target bonus based on actual performance for the year of the termination, (iii) any earned but unpaid bonus for any completed fiscal year ending on or prior to his termination date, and (iv) any insurance benefits to which he and his beneficiaries are entitled as a result of his death or disability.

If Mr. Wise’s employment is terminated by the Company without cause or by him for good reason (such a termination, a “qualifying termination”) within two years after a change in control, Mr. Wise will receive (i) payment of accrued obligations, (ii) any earned but unpaid bonus for any completed fiscal year ending on or prior to his termination date, (iii) a lump sum severance payment equal to (a) one-and-a-half times his annual base salary plus (b) one-and-a-half times his annual target bonus plus (c) a pro-rata portion of his annual target bonus based on the portion of the year during which he was employed by the Company prior to the qualifying termination, (iv) full vesting of all equity awards (other than any performance-based restricted stock units, which will vest in accordance with the applicable award agreement) and (v) continuation of up to 18 months of health and dental benefits for Mr. Wise and his qualified beneficiaries provided he elects continued coverage under COBRA.

In the event of a qualifying termination prior to a change in control or more than two years thereafter, Mr. Wise would be eligible for similar benefits, although (i) his severance payment would be limited to his annual base salary and payable over a 12-month period, (ii) his pro-rata bonus would be based on actual performance for the year of termination, (iii) his equity award vesting would be limited to accelerated vesting of all time-based equity awards that would otherwise have vested within 12 months following his termination date and (iv) continuation of health benefits under COBRA would be limited to 12 months.

There are no other arrangements or understandings between Mr. Wise and any other person pursuant to which Mr. Wise was appointed to the position of Chief Commercial Officer of the Company and Mr. Wise is not a party to any transaction that would require disclosure under Item 404(a) of Regulation S-K. There is no family relationship between Mr. Wise and any director, executive officer, or person nominated or chosen by the Company to become a director or executive officer of the Company.

ITEM 7.01 -
Regulation FD Disclosure.

On May 23, 2022, the Company issued a press release announcing the appointment of Mr. Wise as Chief Commercial 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
     
 
Press release issued by Insmed Incorporated on May 23, 2022.
104
  
Cover Page Interactive Date File (embedded within the Inline XBRL document).

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 23, 2022
INSMED INCORPORATED
   
 
By:
/s/ Michael Smith
 
Name:
Michael Smith
 
Title:
General Counsel and Corporate Secretary


Exhibit 99.1


Insmed Names Drayton Wise Chief Commercial Officer
 
BRIDGEWATER, N.J., May 23, 2022 /PRNewswire/ — Insmed Incorporated (Nasdaq:INSM), a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases, today announced the appointment of Drayton Wise as Chief Commercial Officer, effective May 23, 2022. In addition to his current responsibilities leading the global ARIKAYCE® (amikacin liposome inhalation suspension) franchise and U.S. commercial activities, Mr. Wise will assume responsibility for all of Insmed’s global commercial functions. Mr. Wise will also serve as a member of Insmed’s Executive Committee.
 
“We are thrilled to promote Drayton to Chief Commercial Officer at this critical inflection point for Insmed, as we commercialize ARIKAYCE in three major territories and prepare for the potential global launch of brensocatib and potential label expansion of ARIKAYCE to a frontline patient population,” said Will Lewis, Chair and Chief Executive Officer of Insmed. “Drayton is a trusted leader who exemplifies patient focus. In his eight-year tenure at Insmed, he has played a pivotal role in building the U.S. commercial organization and successfully launching ARIKAYCE around the world. I am excited to expand Drayton’s responsibilities as we prepare to significantly extend our commercial reach.”
 
Mr. Wise joined Insmed in 2014, holding positions of increasing responsibility in the Commercial organization and most recently serving as Senior Vice President, Head of U.S., and General Manager of ARIKAYCE. Prior to Insmed, he held various sales and commercial roles at Novartis from 1999 to 2014.
 
“I’m incredibly proud of the successful commercial organization we’ve built over the past several years with some of the best talent in the industry,” commented Mr. Wise. “I look forward to continuing to build our team globally and laying the groundwork for launching new products and indications as we prepare to serve many more patients with serious and rare diseases.”
 
With Mr. Wise assuming more direct leadership of Insmed’s commercial business, Roger Adsett, Chief Operating Officer, will focus on overseeing Insmed’s overall business operations on a global basis, while continuing to provide valuable commercial insights and strategic perspective for the Company.
 
“Under Roger’s steady operational leadership, Insmed has evolved into the global commercial organization we are today, and his continued strategic guidance and focus on operational excellence will be critical as we prepare for the significant milestones ahead,” added Mr. Lewis. “I am very proud of the world-class leadership team we have built at Insmed to guide us into the next chapter.”

About Insmed
 
Insmed Incorporated is a global biopharmaceutical company on a mission to transform the lives of patients with serious and rare diseases. Insmed’s first commercial product is a first-in-disease therapy approved in the United States, Europe, and Japan to treat a chronic, debilitating lung disease. The Company is also progressing a robust pipeline of investigational therapies targeting areas of serious unmet need, including neutrophil-mediated inflammatory diseases and rare pulmonary disorders. Insmed is headquartered in Bridgewater, New Jersey, with a footprint across Europe and in Japan. For more information, visit www.insmed.com.
 

Forward-looking Statements
 
This press release contains forward-looking statements that involve substantial risks and uncertainties. “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 timings discussed, projected, anticipated or indicated in any forward-looking statements. Such risks, uncertainties and other factors include, among others, the following: failure to obtain, or delays in obtaining, regulatory approvals for ARIKAYCE outside the U.S., Europe or Japan, or for the Company’s product candidates in the U.S., Europe, Japan or other markets, including regulatory approval for the Lamira® Nebulizer System and the drug delivery device for TPIP in each market and for each usage; failure to successfully commercialize ARIKAYCE, the Company’s only approved product, in the U.S., Europe or Japan (amikacin liposome inhalation suspension, Liposomal 590 mg Nebuliser Dispersion, and amikacin sulfate inhalation drug product, respectively), or to maintain U.S., European or Japanese approval for ARIKAYCE; business or economic disruptions due to catastrophes or other events, including natural disasters or public health crises; impact of the COVID-19 pandemic and efforts to reduce its spread on the Company’s business, employees, including key personnel, patients, partners and suppliers; risk that brensocatib does not prove effective or safe for patients in ongoing and future clinical studies, including the ASPEN study; risk that TPIP does not prove to be effective or safe for patients in ongoing and future clinical studies; uncertainties in the degree of market acceptance of ARIKAYCE by physicians, patients, third-party payors and others in the healthcare community; the Company’s inability to obtain full approval of ARIKAYCE from the U.S. Food and Drug Administration, including the risk that the Company will not successfully or in a timely manner complete the study to validate a patient reported outcome tool and the confirmatory post-marketing clinical trial required for full approval of ARIKAYCE; inability of the Company, PARI or the Company’s other third-party manufacturers to comply with regulatory requirements related to ARIKAYCE or the Lamira® Nebulizer System; the Company’s inability to obtain adequate reimbursement from government or third-party payors for ARIKAYCE or acceptable prices for ARIKAYCE; development of unexpected safety or efficacy concerns related to ARIKAYCE or the Company’s product candidates; inaccuracies in the Company’s estimates of the size of the potential markets for ARIKAYCE, brensocatib, TPIP or the Company’s other product candidates or in data the Company has used to identify physicians, expected rates of patient uptake, duration of expected treatment, or expected patient adherence or discontinuation rates; the Company’s inability to create an effective direct sales and marketing infrastructure or to partner with third parties that offer such an infrastructure for distribution of ARIKAYCE or any of the Company’s product candidates that are approved in the future; failure to obtain regulatory approval to expand ARIKAYCE’s indication to a broader patient population; risk that the Company’s competitors may obtain orphan drug exclusivity for a product that is essentially the same as a product the Company is developing for a particular indication; failure to successfully predict the time and cost of development, regulatory approval and commercialization for novel gene therapy products; failure to successfully conduct future clinical trials for ARIKAYCE, brensocatib, TPIP and the Company’s other product candidates due to the Company’s limited experience in conducting preclinical development activities and clinical trials necessary for regulatory approval and its potential inability to enroll or retain sufficient patients to conduct and complete the trials or generate data necessary for regulatory approval, among other things; risks that the Company’s clinical studies will be delayed or that serious side effects will be identified during drug development; failure of third parties on which the Company is dependent to manufacture sufficient quantities of ARIKAYCE or the Company’s product candidates for commercial or clinical needs, to conduct the Company’s clinical trials, or to comply with the Company’s agreements or laws and regulations that impact the Company’s business or agreements with the Company; the Company’s inability to attract and retain key personnel or to effectively manage the Company’s growth; the Company’s inability to successfully integrate its recent acquisitions and appropriately manage the amount of management’s time and attention devoted to integration activities; risks that the Company’s acquired technologies, products and product candidates are not commercially successful; the Company’s inability to adapt to its highly competitive and changing environment; risk that the Company is unable to maintain its significant customers; risk that government healthcare reform materially increases the Company’s costs and damages its financial condition; the Company’s inability to adequately protect its intellectual property rights or prevent disclosure of its trade secrets and other proprietary information and costs associated with litigation or other proceedings related to such matters; restrictions or other obligations imposed on the Company by agreements related to ARIKAYCE or the Company’s product candidates, including its license agreements with PARI and AstraZeneca AB, and failure of the Company to comply with its obligations under such agreements; the cost and potential reputational damage resulting from litigation to which the Company is or may become a party, including product liability claims; risk that the Company’s operations are subject to a material disruption in the event of a cybersecurity attack or issue; business disruptions or expenses related to the upgrade to the Company’s enterprise resource planning system; the Company’s limited experience operating internationally; changes in laws and regulations applicable to the Company’s business, including any pricing reform, and failure to comply with such laws and regulations; the Company’s history of operating losses, and the possibility that the Company may never achieve or maintain profitability; goodwill impairment charges affecting the Company’s results of operations and financial condition; inability to repay the Company’s existing indebtedness and uncertainties with respect to the Company’s ability to access future capital; and delays in the execution of plans to build out an additional third-party manufacturing facility approved by the appropriate regulatory authorities and unexpected expenses associated with those plans.
 
The Company may not actually achieve the results, plans, intentions or expectations indicated by the Company’s forward-looking statements because, by their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. For additional information about the risks and uncertainties that may affect the Company’s 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, 2021 and any subsequent Company filings with the Securities and Exchange Commission (SEC).
 
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 SEC, 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.
 

Contact:
 
Investors:
 
Eleanor Barisser
Associate Director, Investor Relations
Insmed
(718) 594-5332
eleanor.barisser@insmed.com

Media:

Mandy Fahey
Executive Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com

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