BRIDGEWATER, N.J., May 4, 2020 /PRNewswire/ -- Insmed
Incorporated (Nasdaq: INSM) announced today that it intends to
offer and sell shares of its common stock in an underwritten public
offering. In addition, Insmed intends to grant the underwriters a
30-day option to purchase up to an additional 15% of the shares of
common stock offered in the public offering. All of the shares to
be sold in the offering are to be sold by Insmed. The offering is
subject to market and other conditions, and there can be no
assurance as to whether or when the offering may be completed, or
as to the actual size or terms of the offering.
SVB Leerink is acting as sole bookrunning manager for the
offering.
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 on May
19, 2017. A preliminary prospectus supplement relating to
the offering will be filed with the SEC and will be available on
the SEC's website at www.sec.gov. Copies of the preliminary
prospectus supplement and the accompanying prospectus related to
this offering may be obtained, when available, from SVB Leerink
LLC, Attention: Syndicate Department, One Federal Street, 37th
Floor, Boston, Massachusetts
02110, by telephone: 1-800-808-7525, ext. 6218 or by email at
syndicate@svbleerink.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, ARIKAYCE®
(amikacin liposome inhalation suspension), is the first and only
therapy approved in the United
States for the treatment of refractory 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 chronic,
debilitating condition that can cause severe and permanent lung
damage. Insmed's earlier-stage clinical pipeline includes
brensocatib, a novel oral reversible inhibitor of dipeptidyl
peptidase 1 with therapeutic potential in non-cystic fibrosis
bronchiectasis and other inflammatory diseases, and treprostinil
palmitil, 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) 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
risks, uncertainties and other factors include, among others, the
following: the risks and uncertainties associated with market
conditions and the satisfaction of customary closing conditions
related to the proposed public offering; the risk that brensocatib
does not prove effective or safe for patients in the STOP-COVID19
study; business or economic disruptions due to catastrophes or
other events, including natural disasters or public health crises;
impact of the novel coronavirus (COVID-19) pandemic and efforts to
reduce its spread on our business, employees, including key
personnel, patients, partners and suppliers; the risk that the full
data set from the WILLOW study, our six-month Phase 2 trial of
brensocatib in patients with NCBFE or data generated in further
clinical trials of brensocatib will not be consistent with the
top-line results of the study; 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 payors
and others in the healthcare community; the Company's inability to
obtain full approval of ARIKAYCE from the FDA, including the risk
that the Company will not timely and successfully complete the
study to validate a PRO tool and complete the confirmatory
post-marketing study 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
brensocatib; inaccuracies in the Company's estimates of the size of
the potential markets for ARIKAYCE or brensocatib 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, brensocatib and the Company's other 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, or delays in obtaining, regulatory approvals for ARIKAYCE
outside the U.S. or for the Company's product candidates in the
U.S., Europe, Japan or other markets, including the
United Kingdom as a result of its
recent exit from the European Union; 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 the Company's
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 its 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; 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; 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 FDA-approved 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 factors discussed in Item 1A, "Risk Factors," in the
Company's Annual Report on Form 10-K for the year
ended December 31, 2019, our Quarterly Report on Form 10-Q for
the quarter ended March 31,
2020 and any subsequent Company 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.
Contact:
Investors:
Argot Partners
Laura Perry or Heather Savelle
(212) 600-1902
insmed@argotpartners.com
Media:
Mandy Fahey
Senior Director, Corporate Communications
Insmed
(732) 718-3621
amanda.fahey@insmed.com
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SOURCE Insmed Incorporated