Insmed Incorporated (Nasdaq:INSM) announced today that it has
commenced an underwritten public offering of $250 million of shares
of its common stock. All of the shares of common stock in the
offering would be sold by Insmed. In addition, Insmed intends
to grant the underwriters a 30-day option to purchase up to an
additional 15 percent of the shares of common stock offered in the
public offering at the public offering price, less the underwriting
discount. 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.
Insmed intends to use the net proceeds from this offering to
fund ongoing and future clinical development of amikacin liposome
inhalation suspension (ALIS) for patients with treatment refractory
nontuberculous mycobacteria (NTM) lung disease caused by
Mycobacterium avium complex (MAC) and its efforts to obtain
potential regulatory approvals and, if approved, commercialize ALIS
in its approved indication; invest in increased third-party
manufacturing capacity for and commercial inventory production of
ALIS in anticipation of possible commercial launch, initially in
the United States and subsequently in Japan and other countries;
fund further clinical development of INS1007, a novel oral
reversible inhibitor of dipeptidyl peptidase 1; and fund working
capital, potential debt repayment, capital expenditures, 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.
Goldman Sachs & Co. LLC and Leerink Partners LLC are acting
as joint book-running managers for the offering. Evercore Group
L.L.C. is acting as a passive bookrunner. Stifel, Nicolaus &
Company, Incorporated is acting as co-lead.
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) and
became automatically effective upon filing. 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 (1) Goldman Sachs & Co. LLC at Prospectus
Department, 200 West Street, New York, NY 10282, by telephone at
1-866-471-2526, by facsimile at 212-902-9316 or by email at
prospectus-ny@ny.email.gs.com, or (2) Leerink Partners LLC at
Attention: Syndicate Department, One Federal Street, 37th Floor,
Boston, MA 02110, by telephone at (800) 808-7525 extension 6132 or
by email at syndicate@leerink.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 state or jurisdiction in which such an
offer, solicitation or sale would be unlawful prior to registration
or qualification under the securities laws of any such state or
jurisdiction.
About Insmed
Insmed Incorporated is a global biopharmaceutical company
focused on the unmet needs of patients with rare diseases. The
Company’s lead product candidate is ALIS for adult patients with
treatment refractory NTM lung disease caused by MAC, which is a
rare and often chronic infection that is capable of causing
irreversible lung damage and can be fatal. The Company is not aware
of any approved inhaled therapies specifically indicated for
refractory NTM lung disease caused by MAC in North America, Japan
or Europe. 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 INS1009, an inhaled nanoparticle 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.
"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: risks that the full six-month data
from the CONVERT study or subsequent data from the remainder of the
study’s treatment and off-treatment phases will not be consistent
with the top-line six-month results of the study; uncertainties in
the research and development of the Company’s existing product
candidates, including due to delays in data readouts, such as the
full data from the CONVERT study, patient enrollment and retention
or failure of the Company’s preclinical studies or clinical trials
to satisfy pre-established endpoints, including secondary endpoints
in the CONVERT study and endpoints in the CONVERT extension study;
failure to obtain, or delays in obtaining, regulatory approval from
the U.S. Food and Drug Administration, Japan’s Ministry of Health,
Labour and Welfare, the European Medicines Agency, and other
regulatory authorities for the Company’s product candidates or
their delivery devices, such as the eFlow Nebulizer System,
including due to insufficient clinical data, selection of endpoints
that are not satisfactory to regulators, complexity in the review
process for combination products or inadequate or delayed data from
a human factors study required for U.S. regulatory approval;
failure to maintain regulatory approval for the Company’s product
candidates, if received, due to a failure to satisfy post-approval
regulatory requirements, such as the submission of sufficient data
from confirmatory clinical studies; safety and efficacy concerns
related to the Company’s product candidates; lack of experience in
conducting and managing preclinical development activities and
clinical trials necessary for regulatory approval, including the
regulatory filing and review process; failure to comply with
extensive post-approval regulatory requirements or imposition of
significant post-approval restrictions on the Company’s product
candidates by regulators; uncertainties in the rate and degree of
market acceptance of product candidates, if approved; inability to
create an effective direct sales and marketing infrastructure or to
partner with third parties that offer such an infrastructure for
distribution of the Company’s product candidates, if approved;
inaccuracies in the Company’s estimates of the size of the
potential markets for the Company’s product candidates or
limitations by regulators on the proposed treatment population for
the Company’s product candidates; failure of third parties on which
the Company is dependent to conduct the Company’s clinical trials,
to manufacture sufficient quantities of the Company’s product
candidates for clinical or commercial needs, including the
Company’s raw materials suppliers, or to comply with the Company’s
agreements or laws and regulations that impact the Company’s
business; inaccurate estimates regarding the Company’s future
capital requirements, including those necessary to fund the
Company’s ongoing clinical development, regulatory and
commercialization efforts as well as milestone payments or
royalties owed to third parties; failure to develop, or to license
for development, additional product candidates, including a failure
to attract experienced third-party collaborators; uncertainties in
the timing, scope and rate of reimbursement for the Company’s
product candidates; 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
or to obtain additional capital when needed; failure to obtain,
protect and enforce the Company’s patents and other intellectual
property and costs associated with litigation or other proceedings
related to such matters; restrictions imposed on the Company by
license agreements that are critical for the Company’s product
development, 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; competitive
developments affecting the Company’s product candidates and
potential exclusivity related thereto; the cost and potential
reputational damage resulting from litigation to which the Company
is a party, including, without limitation, the class action lawsuit
pending against the Company; loss of key personnel; lack of
experience operating internationally; and risks that the net
proceeds from the offering are not spent as currently intended or
in ways that enhance the value of your investment in the Company’s
common stock.
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, 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:
Blaine Davis
Vice President, Head of Investor Relations
Insmed Incorporated
(908) 947-2841
blaine.davis@insmed.com
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