BRIDGEWATER, N.J., May 28, 2024
/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 that it
intends to offer and sell $500
million of 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.
Goldman Sachs & Co. LLC and Leerink Partners are acting as
joint book-running managers for the offering.
The public offering of common stock described above is being
made pursuant to Insmed's shelf registration statement on Form S-3
(File No. 333-272088) that was previously filed with the Securities
and Exchange Commission (SEC) and became automatically effective on
May 19, 2023. A preliminary
prospectus supplement relating to and describing the terms of 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 relating to this
offering may be obtained, when available, from Goldman Sachs &
Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526,
facsimile: 212-902-9316 or by emailing
Prospectus-ny@ny.email.gs.com or Leerink Partners LLC,
Attention: Syndicate Department, 53 State Street,
40th Floor, Boston, MA 02109, by telephone at (800)
808-7525, ext. 6105, 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 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 a first-in-disease
therapy approved in the United
States, Europe, and
Japan to treat a chronic,
debilitating lung disease. The Company is progressing a robust
pipeline of investigational therapies targeting areas of serious
unmet need, including neutrophil-mediated inflammatory diseases and
rare pulmonary disorders. Insmed is also advancing an early-stage
research engine encompassing a wide range of technologies and
modalities, including artificial intelligence-driven protein
engineering, gene therapy, and protein manufacturing. Insmed is
headquartered in Bridgewater, New
Jersey, with additional offices and research locations
throughout the United States,
Europe, and Japan.
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: the risks and uncertainties associated with market
conditions and the satisfaction of customary closing conditions
related to the public offering; failure to continue to successfully
commercialize ARIKAYCE, our 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 US,
European or Japanese approval for ARIKAYCE; uncertainties or
changes in the degree of market acceptance of ARIKAYCE or, if
approved, brensocatib or TPIP by physicians, patients, third-party
payors and others in the healthcare community; our inability to
obtain full approval of ARIKAYCE from the U.S. Food and Drug
Administration, including the risk that we will not successfully or
in a timely manner validate a patient reported outcome tool and
complete the confirmatory post-marketing clinical trial required
for full approval of ARIKAYCE, or our failure to obtain regulatory
approval to expand ARIKAYCE's indication to a broader patient
population; inability of us, PARI Pharma GmbH or our other
third-party manufacturers to comply with regulatory requirements
related to ARIKAYCE or the Lamira® Nebulizer System
(Lamira); our inability to obtain and maintain adequate
reimbursement from government or third-party payors for ARIKAYCE
or, if approved, brensocatib or TPIP or acceptable prices for
ARIKAYCE or, if approved, brensocatib or TPIP; failure to obtain,
or delays in obtaining, regulatory approvals for brensocatib, TPIP
or our other product candidates in the U.S., Europe or Japan or regulatory approvals for potential
future brensocatib or TPIP indications; failure to successfully
commercialize brensocatib, TPIP or our other product candidates, if
approved by applicable regulatory authorities, in the U.S.,
Europe or Japan, or to maintain US, European or Japanese
approval for brensocatib, TPIP or our other product candidates, if
approved; development of unexpected safety or efficacy concerns
related to ARIKAYCE, brensocatib, TPIP or our other product
candidates; inaccuracies in our estimates of the size of the
potential markets for ARIKAYCE, brensocatib, TPIP or our other
product candidates or in data we have used to identify physicians,
expected rates of patient uptake, duration of expected treatment,
or expected patient adherence or discontinuation rates; the risks
and uncertainties associated with, and the perceived benefits of,
our secured senior loan with certain funds managed by Pharmakon
Advisors, LP and our royalty financing with OrbiMed Royalty &
Credit Opportunities IV, LP, including our ability to maintain
compliance with the covenants in the agreements for the senior
secured loan and royalty financing and the impact of the
restrictions on our operations under these agreements; our
inability to create or maintain an effective direct sales and
marketing infrastructure or to partner with third parties that
offer such an infrastructure for distribution of ARIKAYCE or, if
approved, brensocatib or TPIP; risk that brensocatib or TPIP does
not prove to be effective or safe for patients in ongoing and
future clinical studies; risk that our competitors may obtain
orphan drug exclusivity for a product that is essentially the same
as a product we are 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 our other product candidates
and our potential inability to enroll or retain sufficient patients
to conduct and complete the trials or generate data necessary for
regulatory approval of our product candidates or to permit the use
of ARIKAYCE in the broader population of patients with
Mycobacterium avium complex lung disease, among other
things; risks that our clinical studies will be delayed, that
serious side effects will be identified during drug development, or
that any protocol amendments submitted will be rejected; the risk
that the full data set from the ASPEN study or data generated in further
clinical trials of brensocatib will not be consistent with the
topline results of the ASPEN
study; risks that interim or partial data sets are not
representative of a complete or larger data set or that blinded
data will not be predictive of unblinded data; failure to obtain,
or delays in obtaining, regulatory approvals for ARIKAYCE outside
the U.S., Europe or Japan, including separate regulatory approval
for Lamira in each market and for each usage; failure of third
parties on which we are dependent, including Esteve
Pharmaceuticals, S.A., Thermo Fisher Scientific, Inc. or the
Company's other third-party manufacturers, to manufacture
sufficient quantities of ARIKAYCE, brensocatib or TPIP for
commercial or clinical needs, to conduct our clinical trials, or to
comply with our agreements or laws and regulations that impact our
business or agreements with us; our inability to attract and retain
key personnel or to effectively manage our growth; our inability to
successfully integrate our recent acquisitions and appropriately
manage the amount of management's time and attention devoted to
integration activities; risks that our acquired technologies,
products and product candidates are not commercially successful;
inability to adapt to our highly competitive and changing
environment; inability to access, upgrade or expand our technology
systems or difficulties in updating our existing technology or
developing or implementing new technology; risk that we are unable
to maintain our significant customers; risk that government
healthcare reform materially increases our costs and damages our
financial condition; business or economic disruptions due to
catastrophes or other events, including natural disasters or public
health crises; risk that our current and potential future use of
artificial intelligence and machine learning may not be successful;
deterioration in general economic conditions in the U.S.,
Europe, Japan and globally, including the effect of
prolonged periods of inflation, affecting us, our suppliers,
third-party service providers and potential partners; the strength
and enforceability of our intellectual property rights or the
rights of third parties; inability to adequately protect our
intellectual property rights or prevent disclosure of our trade
secrets and other proprietary information and costs associated with
litigation or other proceedings related to such matters;
restrictions or other obligations imposed on us by agreements
related to ARIKAYCE or brensocatib, including our license
agreements with PARI Pharma GmbH and AstraZeneca AB, and failure to
comply with our obligations under such agreements; the cost and
potential reputational damage resulting from litigation to which we
are or may become a party, including product liability claims; risk
that our operations are subject to a material disruption in the
event of a cybersecurity attack or issue; our limited experience
operating internationally; changes in laws and regulations
applicable to our business, including any pricing reform and laws
that impact our ability to utilize certain third parties in the
research, development or manufacture of our product candidates, and
failure to comply with such laws and regulations; our history of
operating losses, and the possibility that we never achieve or
maintain profitability; goodwill impairment charges affecting our
results of operations and financial condition; inability to repay
our existing indebtedness and uncertainties with respect to our
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, 2023 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:
Bryan Dunn
Executive Director, Investor Relations
Insmed
(646) 812-4030
bryan.dunn@insmed.com
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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SOURCE Insmed Incorporated