Insmed Incorporated (Nasdaq:INSM) announced today that it has
commenced an underwritten public offering of $300 million aggregate
principal amount of convertible senior notes due 2025. Insmed
intends to grant the underwriters a 30-day option to purchase up to
an additional 15 percent of the aggregate principal amount of the
convertible senior notes being offered, solely to cover
over-allotments. 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 the offering to fund
ongoing and future clinical development of amikacin liposome
inhalation suspension (ALIS) for patients with nontuberculous
mycobacteria (NTM) lung disease caused by Mycobacterium avium
complex (MAC) and its efforts to obtain potential regulatory
approvals for and, if approved, commercialize, ALIS in its approved
indication, including for the build-out of the Company’s commercial
organization to support global expansion activities for ALIS,
including the potential launch of ALIS in the U.S. in 2018; invest
in the build-up of third-party manufacturing capacity and
preparation of commercial inventory, which includes capital and
long term investments; invest in research and development
(primarily associated with the ongoing clinical studies for ALIS
and ongoing phase 2 program for INS 1007, along with advancement of
other pipeline programs, including INS 1009); 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, Morgan Stanley and Leerink Partners
are acting as joint book-running managers for the offering.
Stifel is acting as lead manager for the offering.
A shelf registration statement on Form S-3, as amended by
Post-Effective Amendment No. 1, relating to the public offering of
the convertible senior notes 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 the 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, (2) Morgan Stanley & Co. LLC at
Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New
York, NY 10014, or (3) 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. 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 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 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: 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
(the 312 study); risks that subsequent data from the 312 study will
not be consistent with the interim results; 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, Japan’s Pharmaceuticals and Medical Devices Agency, 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 on desirable terms or
at all; 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 our offerings of our securities are not
spent as currently intended or in ways that enhance the value of
your investment.
We may not actually achieve the results, plans, intentions or
expectations indicated by our 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 Quarterly Report on Form
10-Q for the three months ended September 30, 2017 and any
subsequent filings with the Securities and Exchange Commission,
including the registration statement and prospectus supplement
related to the proposed offering.
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. You
should read this press release with the understanding that our
actual future results may be materially different from those
expressed in 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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