BRIDGEWATER, N.J., May 21, 2019 /PRNewswire/ -- Insmed Incorporated
(Nasdaq: INSM) announced today that it priced a registered
underwritten public offering of 9,615,385 shares of its common
stock, at a price to the public of $26.00 per share before underwriting discounts
and commissions. Gross proceeds from the offering of these shares,
before deducting underwriting discounts and commissions, are
expected to be approximately $250.0
million. The underwriters have been granted 30-day
options to purchase up to an additional 1,042,307 shares of common
stock from Insmed and up to 400,000 shares of common stock from
William H. Lewis, the Company's
Chairman and Chief Executive Officer.
Insmed intends to use its net proceeds from this offering to
continue to commercialize ARIKAYCE® (amikacin liposome
inhalation suspension); conduct further trials of ARIKAYCE,
including Insmed's required confirmatory trial to assess and
describe the clinical benefit of ARIKAYCE in patients with
Mycobacterium avium complex (MAC) lung disease; fund further
clinical development of INS1007 and INS1009; invest in increased
third-party manufacturing capacity for ARIKAYCE; fund business
expansion activities in Europe and
Japan; fund working capital,
potential debt repayment, capital expenditures, and general
research and development; and for other general corporate purposes,
which may include the acquisition or in-license of additional
compounds, product candidates, technology or businesses.
Morgan Stanley & Co. LLC, SVB Leerink LLC and Goldman Sachs
& Co. LLC are acting as joint book-running managers for the
offering. Credit Suisse Securities (USA) LLC, Stifel, Nicolaus & Company,
Incorporated and H.C. Wainwright & Co. are acting as
co-managers for the offering. The offering is expected to close on
May 24, 2019, subject to the
satisfaction of customary closing conditions.
A shelf registration statement on Form S-3 relating to the
public offering of the shares of common stock described above has
been filed with the Securities and Exchange Commission (SEC), as
amended by Post-Effective Amendment No. 1 thereto, and became
automatically effective upon filing. A preliminary prospectus
supplement relating to and describing the terms of the offering was
filed with the SEC and is available on the SEC's website at
www.sec.gov. Copies of the final prospectus supplement and the
accompanying prospectus relating to this offering may be obtained,
when available, from Morgan Stanley & Co. LLC, Attention:
Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; SVB Leerink LLC,
Attention: Syndicate Department, One Federal Street, 37th Floor,
Boston, Massachusetts 02110,
telephone: 1-800-808-7525, ext. 6132 or email at
syndicate@svbleerink.com; and Goldman Sachs & Co. LLC,
Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526,
facsimile: 1-212-902-9316 or email at
prospectus-ny@ny.email.gs.com.
This press release shall not constitute an offer to sell or a
solicitation of an offer to buy, nor shall there be any sale of
these securities in any jurisdiction in which such an offer,
solicitation or sale would be unlawful prior to registration or
qualification under the securities laws of any such
jurisdiction.
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 ARIKAYCE®
(amikacin liposome inhalation suspension), which is approved
in the United States (U.S.) for
the treatment of Mycobacterium avium complex (MAC) lung
disease as part of a combination antibacterial drug regimen for
adult patients with limited or no alternative treatment options.
MAC lung disease is a rare and often chronic infection that can
cause irreversible lung damage and can be fatal. Insmed's
earlier-stage clinical pipeline includes INS1007, a novel oral
reversible inhibitor of dipeptidyl peptidase 1 with therapeutic
potential in non-cystic fibrosis bronchiectasis and other
inflammatory diseases, and INS1009, an inhaled formulation of a
treprostinil prodrug that may offer a differentiated product
profile for rare pulmonary disorders, including pulmonary arterial
hypertension.
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) 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
risks, uncertainties and other factors include, among others, the
following: failure to successfully commercialize or maintain U.S.
approval for ARIKAYCE, the Company's only approved product;
uncertainties in the degree of market acceptance of ARIKAYCE by
physicians, patients, third-party payers and others in the
health-care 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 complete
the confirmatory post-marketing study required for full approval;
inability of the Company, PARI Pharma GmbH 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 payers for ARIKAYCE or acceptable prices for ARIKAYCE;
development of unexpected safety or efficacy concerns related to
ARIKAYCE; inaccuracies in the Company's estimates of the size of
the potential markets for ARIKAYCE 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; failure to obtain regulatory approval to
expand ARIKAYCE's indication to a broader patient population;
failure to successfully conduct future clinical trials for ARIKAYCE
and the Company's product candidates, including due to the
Company's limited experience in conducting preclinical development
activities and clinical trials necessary for regulatory approval
and the Company's inability to enroll or retain sufficient patients
to conduct and complete the trials or generate data necessary for
regulatory approval; risks that the Company's clinical studies will
be delayed or that serious side effects will be identified during
drug development; failure to obtain regulatory approvals for
ARIKAYCE outside the U.S. or for the Company's product candidates
in the U.S., Europe, Japan or other markets; 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 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 its growth; the Company's inability to adapt to its highly
competitive and changing environment; 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 the Company's license agreements with
PARI Pharma GmbH and AstraZeneca AB, and failure to comply with the
Company's 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; the
Company's limited experience operating internationally; changes in
laws and regulations applicable to the Company's business and
failure to comply with such laws and regulations; inability to
repay the Company's existing indebtedness and uncertainties with
respect to its ability to access future capital, including failure
to complete this common stock offering; and delays in the execution
of plans to build out and move into the leased space at the
Company's new headquarters and to build out an additional
third-party manufacturing facility 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 risk factors discussed in Item 1A, "Risk Factors," in the
Company's Annual Report on Form 10-K for the year ended
December 31, 2018 and in the
Company's subsequent filings with the 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.
Investor Contact:
Blaine Davis
Head of Investor Relations and Corporate Communications
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com
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SOURCE Insmed Incorporated