TIDMAMYT
- Combined business will have three approved commercial products,
lomitapide (Lojuxta(R)/Juxtapid(R)), metreleptin (Myalept(R)/
Myalepta(R)), octreotide (MYCAPSSA(R)) and a robust clinical pipeline
- Lead pipeline product Oleogel-S10*(Filsuvez(R)) under regulatory
review in the US and EU
- Deal expected to pave a path to a combined potential $1BN peak revenue
for Amryt
- The acquisition is expected to deliver estimated annual cost synergies
of approximately $50M and be revenue and EBITDA accretive and cash
generative in the first full calendar year of combined operations and
substantially accretive thereafter
- MYCAPSSA(R) is the first and only oral somatostatin analog ("SSA")
approved for appropriate patients with acromegaly in a global market
estimated at approximately $800M with the potential to expand into the
neuroendocrine tumor ("NET") market estimated at approximately $1.9BN
globally and has a confirmed modified 505(b)(2) regulatory pathway in
the US
- Acquisition leverages Amryt's proven commercial execution ability,
global infrastructure and integration capabilities to accelerate
MYCAPSSA(R) launch in the US and international markets
- All stock transaction with Amryt shareholders to own approximately 60%
and Chiasma shareholders approximately 40% of the combined entity with
voting agreements received from lead shareholders of both businesses -
Athyrium Capital Management LP, Highbridge Capital Management and MPM
Capital
Conference call and webcast for analysts and investors today at 0830 EDT
(1330 BST)
DUBLIN, Ireland, and Boston MA, May 5, 2021, Amryt (Nasdaq: AMYT, AIM:
AMYT), a global, commercial-stage biopharmaceutical company dedicated to
acquiring, developing and commercializing novel treatments for rare
diseases, today announces that it has signed a definitive agreement to
acquire Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination. The
combined company will be a global leader in rare and orphan diseases
with three on-market commercial products, a global commercial and
operational footprint and a significant development pipeline of
therapies with the financial flexibility to execute its growth plans.
The transaction has been approved and recommended by the Boards of both
Amryt and Chiasma.
Under the terms of the transaction, each share of Chiasma common stock
issued and outstanding prior to the consummation of the transaction will
be exchanged for 0.396 Amryt American Depositary Shares ("ADSs"), each
representing five Amryt ordinary shares. As of the close of trading on
May 4, 2021 Amryt's ordinary shares on AIM were GBP2.00 ($2.78) per
share and Amryt's ADS's on Nasdaq were $12.95 (GBP9.31) per ADS.
Amryt already has in place the infrastructure, expertise and the
financial flexibility to realize the full potential of MYCAPSSA(R)
globally and further develop life-cycle management opportunities to
expand the benefits of MYCAPSSA(R) to other patient populations
including NET. The transaction is expected to accelerate and diversify
Amryt's growing revenues and Amryt expects to deliver estimated annual
cost synergies of approximately $50M.
Dr. Joe Wiley, Chief Executive Officer of Amryt, commented: "We are
really excited by today's news and are looking forward to welcoming the
Chiasma team to Amryt. Amryt has grown significantly in the past six
years and our success to date is due to the phenomenal commitment and
drive of the Amryt team. This transaction brings together two teams that
have a strong track record of execution and passion for developing
therapies that can help improve the lives of patients in need. The
addition of MYCAPSSA(R), which was recently launched in the US, to our
commercial product portfolio represents a strong strategic, operational
and commercial fit given the significant call-point overlap that exists
across our portfolio.
This deal further solidifies our position as a global leader in treating
rare and orphan conditions. The combined business will have three
approved commercial products and an exciting pipeline of development
assets. Our lead development candidate, Oleogel-S10, is currently
progressing through the regulatory process in the US and EU and, if
approved, will bring our portfolio of commercial products to four. We
see significant revenue growth opportunities for MYCAPSSA(R) in
acromegaly and are also very excited to further develop the potential
for MYCAPSSA(R) in patients with carcinoid symptoms stemming from NET
where we believe the commercial opportunity is significant. With the
addition of NET, our combined pipeline will have four product candidates
in late clinical stages as well as our exciting pre-clinical gene
therapy asset, AP103 in dystrophic Epidermolysis Bullosa ("EB").
The proposed transaction will leverage our track record of successful
integration and significantly enhance our future growth plans in highly
attractive markets globally. With this transaction, we believe that we
can continue the strong growth trajectory already underway at Amryt and
have the financial strength to execute our future growth plans."
Raj Kannan, Chief Executive Officer of Chiasma commented: "I am
incredibly proud of what the team at Chiasma has been able to accomplish
and we look forward to joining Amryt in continuing to focus on making
the lives of patients with rare diseases better. The merger with Amryt
allows the combined company to significantly leverage the operational
efficiencies in successfully commercializing MYCAPSSA(R) globally and
expand the potential benefits of MYCAPSSA(R) to other patients with
unmet needs. The combined business has significant potential to further
enhance shareholder value with a diversified portfolio of both marketed
products and a meaningful late-stage pipeline that could potentially
drive future growth opportunities. I am confident that this combination
with Amryt, given their track record of success, positions us well to
deliver long-term value for our patients and for our shareholders."
Transaction Benefits
A leading orphan and rare disease company with a diversified portfolio
of established and growing products and financial strength - Consistent
with Amryt's shareholder endorsed strategy to acquire, develop and
commercialize novel treatments for rare diseases, the combined portfolio
of products offers a pathway to a potential $1BN of peak revenues. Amryt
has a proven track record of successful integration and expects to
deliver approximately $50M in cost synergies per annum. Both Amryt and
Chiasma currently enjoy a significant degree of customer call-point
overlap and combining operations will provide significant salesforce
scale opportunities. In the endocrinology space, both
Myalept(R)/Myalepta(R) and MYCAPSSA(R) are growth assets and by
combining and scaling salesforces, Amryt believes that this will not
only drive MYCAPSSA(R) adoption but also enable further
Myalept(R)/Myalepta(R) revenue growth. The combined business will have
three approved commercial products as well as a robust clinical
pipeline. Both Oleogel-S10 (if approved) and MYCAPSSA(R) are
first-to-market novel therapies. MYCAPSSA(R) is the first and only oral
SSA approved for appropriate patients with acromegaly and Oleogel-S10
has the potential to be the first approved therapy for EB.
Delivers improved competitive positioning with increased scale in US, EU
and beyond - The transaction is expected to enhance the combined group's
commercial and medical infrastructure globally. Amryt plans to deploy
its significant expertise and commercial platforms to further accelerate
the launch of MYCAPSSA(R) in the US and also to seek MYCAPSSA(R)
approval and launch internationally.
Significant market potential for MYCAPSSA(R) in NET - Amryt believes
MYCAPSSA(R) is well positioned to address the desire for an oral option
in the treatment of carcinoid symptoms associated with NET. Injectable
octreotide is already approved and used in the treatment of NET and SSA
utilization in NET is expected to account for an estimated $1.3BN in the
US and $2.4BN globally by 2028. During the first quarter of 2021,
Chiasma submitted an Investigational New Drug ("IND") application for a
Phase 1 relative bioavailability study followed by a single Phase 3,
randomized, double-blind, placebo-controlled study of MYCAPSSA(R) in
patients with carcinoid syndrome, which are designed to support a
modified 505(b)(2) regulatory pathway for marketing approval. Subject to
ongoing discussions with the FDA and completion of the Phase 1 study, we
plan to commence enrollment to the Phase 3 study as early as H1 2022.
Cultures, values and expertise aligned - Amryt and Chiasma share a deep
commitment and passion for serving patients by developing and bringing
to market innovative therapies. We share a similar business philosophy
of placing patients at the center of everything we do and in celebrating
inclusion and diversity across our business operations.
Expected to deliver significant shareholder value - The acquisition is
expected to be revenue and EBITDA accretive and cash generative in the
first full calendar year of combined operations and substantially
accretive thereafter. Significant value is also expected to be created
through the realization of estimated annual cost synergies of
approximately $50m. We expect that the transaction will result in a
diversified and broad shareholder base with leading biotech investors
supportive of the company's long-term growth plans.
Webcast and Conference Call Details
Management will host a webcast and conference call for analysts and
investors today at 0830 EDT (1330 BST).
Webcast Player URL: https://edge.media-server.com/mmc/p/hdecnon9
Dial in details: Conference ID: 8698345
From the US: +1 646 787 1226
From the UK/International: +44 (0) 203 009 5709
From Ireland: + 353 (0) 1 506 0626
Transaction Overview
-- Recommended acquisition of Chiasma by Amryt in an all-stock transaction
-- Chiasma shareholders will receive 0.396 Amryt ADSs for each share of
Chiasma common stock, subject to rounding for fractional shares. As of
the close of trading on May 4, 2021 Amryt's ordinary shares on AIM were
GBP2.00 ($2.78) per share and Amryt's ADS's on Nasdaq were $12.95
(GBP9.31) per ADS.
-- Based on the fixed exchange ratio, Amryt shareholders prior to the
transaction will own approximately 60% of Amryt post transaction and
Chiasma shareholders prior to the transaction will own approximately 40%
of Amryt post transaction.
-- Chiasma's existing royalty interest financing agreement expected to be
fully repaid on closing delivering a high margin unencumbered asset to
Amryt's portfolio
-- Transaction is endorsed and supported by voting agreements with lead
shareholders - Athyrium Capital Management LP, Highbridge Capital
Management and MPM Capital
-- Transaction is subject to the approval of Amryt and Chiasma shareholders
and other customary closing conditions, including regulatory approvals
-- Subject to the satisfaction or waiver of closing conditions, the
transaction is expected to close in Q3 2021
Listing, Governance and Management
-- Amryt is currently listed on Nasdaq (AMYT) and AIM in London (AMYT) and
will be the publicly quoted company following closing
-- Amryt's global headquarters will remain in Dublin, Ireland and its US
headquarters will remain in Boston, Massachusetts
-- The Amryt team will continue to be led by Dr Joe Wiley, CEO of Amryt
-- Raj Kannan, CEO of Chiasma, is expected to join the Board of Amryt on
closing of the transaction, subject to regulatory approval. Chiasma will
nominate one additional director to join the Board of Amryt, to be
confirmed on closing.
Advisors to Amryt
Moelis & Company LLC is serving as exclusive financial advisor and
Gibson, Dunn & Crutcher LLP is serving as legal advisor to Amryt in this
transaction. Shore Capital is acting as NOMAD and Joint Broker to Amryt.
Advisors to Chiasma
Torreya Capital LLC is serving as financial advisor and Goodwin Procter
LLP is serving as legal advisor to Chiasma. Chiasma's Board of Directors
was provided a fairness opinion by Duff & Phelps.
* For the purposes of this announcement, we use the name Oleogel-S10.
Filsuvez(R) has been selected as the brand name for the product but
please note, Amryt does not, as yet, have regulatory approval for
Filsuvez(R) to treat EB.
About Amryt
Amryt is a global commercial-stage biopharmaceutical company focused on
acquiring, developing and commercializing innovative treatments to help
improve the lives of patients with rare and orphan diseases. Amryt
comprises a strong and growing portfolio of commercial and development
assets.
Amryt's commercial business comprises two orphan disease products -
metreleptin (Myalept(R)/ Myalepta(R)) and lomitapide
(Juxtapid(R)/Lojuxta(R)).
Myalept(R)/Myalepta(R) (metreleptin) is approved in the US (under the
trade name Myalept(R)) as an adjunct to diet as replacement therapy to
treat the complications of leptin deficiency in patients with congenital
or acquired generalized lipodystrophy (GL) and in the EU (under the
trade name Myalepta(R)) as an adjunct to diet for the treatment of
leptin deficiency in patients with congenital or acquired GL in adults
and children two years of age and above and familial or acquired partial
lipodystrophy (PL) in adults and children 12 years of age and above for
whom standard treatments have failed to achieve adequate metabolic
control. For additional information, please follow this link
https://www.globenewswire.com/Tracker?data=WSHd014Nme8R4ynhrdRzyDQUmBi_zo1Ig7_kIdAOJpC-rTEPsTRq9ahjak9RcGknPsufRHWeCpIpv3zKtSEe6AVdyvqxF6SnE9O46sIkHkPEpEbF3i04u4YeKcSU4rYot6PVKNRoB1U3_v8_x6x2pqi6_DNrk0ivbyWPyAWjrNs=
.
Juxtapid(R)/Lojuxta(R) (lomitapide) is approved as an adjunct to a
low-fat diet and other lipid-lowering medicinal products for adults with
the rare cholesterol disorder, Homozygous Familial Hypercholesterolaemia
("HoFH") in the US, Canada, Colombia, Argentina and Japan (under the
trade name Juxtapid(R)) and in the EU, Israel and Brazil (under the
trade name Lojuxta(R)). For additional information, please follow this
link
https://www.globenewswire.com/Tracker?data=WSHd014Nme8R4ynhrdRzyMfOA1yrfFHajGI4d-E8Pj3iYH8Aqm8Z2RNQWob9R_83bForkhkhb4r_FyKBPSZfKSclfmLZle1XnnT1G5nWo9A=
.
Amryt's lead development candidate, Oleogel-S10 (Filsuvez(R)) is a
potential treatment for the cutaneous manifestations of Junctional and
Dystrophic EB, a rare and distressing genetic skin disorder affecting
young children and adults for which there is currently no approved
treatment. Filsuvez(R) has been selected as the brand name for
Oleogel-S10. The product does not currently have regulatory approval to
treat EB.
Amryt's pre-clinical gene therapy platform, AP103, offers a potential
treatment for patients with Dystrophic EB, and is also potentially
relevant to other genetic disorders.
For more information on Amryt, including products, please visit
https://www.globenewswire.com/Tracker?data=Kadx5Hf1eS_3Xgf-2jnf-a4nJ86htEIH_cmGKKOvBpAZ5iO0DAM6Iw45Br_aLx9ZZfv_2s_Zhs1N-9_0Pe5-cQ_DXLfH9oiBaRXZZ6NeKLU=
www.amrytpharma.com.
This announcement contains inside information for the purposes of
article 7 of the Market Abuse Regulation (EU) 596/2014.
The person making this notification on behalf of Amryt is Rory Nealon,
CFO/COO and Company Secretary.
About Chiasma
Chiasma is a commercial stage biopharmaceutical company focused on
developing and commercializing oral therapies to improve the lives of
patients who face challenges associated with their existing treatments
for rare and serious chronic diseases. Employing its Transient
Permeability Enhancer (TPE(R) ) technology platform, Chiasma seeks to
develop oral medications that are currently available only as
injections. In June 2020, Chiasma received FDA approval of MYCAPSSA(R)
for long-term maintenance therapy in acromegaly patients who have
responded to and tolerated treatment with octreotide or lanreotide.
MYCAPSSA, the first and only oral SSA approved by the FDA, is available
for commercial sale. For the financial year to 31 December 2020, Chiasma
reported revenues of $1.1 million and pre-tax loss of $74.8 million.
Total assets amounted to $176.3 million, including cash and cash
equivalents of $15.4 million. Chiasma is headquartered in Needham, MA
with a wholly owned subsidiary in Israel. MYCAPSSA(R), TPE(R) and
Chiasma(R) are registered trademarks of Chiasma. For more information,
please visit the company's website at www.chiasma.com.
About Acromegaly
Acromegaly typically develops when a benign tumor of the pituitary gland
produces too much growth hormone, ultimately leading to significant
health problems. Common features of acromegaly are facial changes,
intense headaches, joint pain, impaired vision and enlargement of the
hands, feet, tongue and internal organs. Serious health conditions
associated with the progression of acromegaly include type 2 diabetes,
hypertension, respiratory disorders and cardiac and cerebrovascular
disease. Chiasma estimates that approximately 8,000 adult acromegaly
patients are chronically treated with SSA injections in the United
States.
About Neuroendocrine Tumors (NET)
NETs arise from neuroendocrine cells throughout the body, most commonly
in the gastrointestinal tract, lung, and rarely, the pancreas. While
well differentiated neuroendocrine tumors are known to be slow growing,
they are often asymptomatic in early stages leading to a substantial
number of patients being diagnosed when the tumors have already spread
regionally or distantly. Capable of secreting hormones and bioactive
amines, approximately 19% of patients have carcinoid syndrome
characterized by secretory diarrhea and flushing. With an annual
incidence rate of 6.98 per 100,000, it is estimated there are greater
than 170,000 individuals living with a diagnosis of NET in the United
States.
About MYCAPSSA
MYCAPSSA(R) (octreotide capsules) has only been approved by the U.S.
Food and Drug Administration for long-term maintenance treatment in
acromegaly patients who have responded to and tolerated treatment with
octreotide or lanreotide. The full Prescribing Information for MYCAPSSA
is available at www.MYCAPSSA.com.
Forward-Looking Statements
This press release relates to the proposed business combination
transaction between Amryt and Chiasma and includes forward-looking
statements containing the words "expect", "anticipate", "intends",
"plan", "estimate", "aim", "forecast", "project" and similar expressions
(or their negative) identify certain of these forward-looking
statements. Forward-looking statements relate to future events and
anticipated results of operations, business strategies, the anticipated
benefits of the proposed transaction, the anticipated impact of the
proposed transaction on the combined company's business and future
financial and operating results, the expected amount and timing of
synergies from the proposed transaction, the anticipated closing date
for the proposed transaction and other aspects of our operations or
operating results. The forward-looking statements in this announcement
are based on numerous assumptions and Amryt's and Chiasma's present and
future business strategies and the environment in which Amryt and
Chiasma expect to operate in the future. Forward-looking statements
involve inherent known and unknown risks, uncertainties and
contingencies because they relate to events and depend on circumstances
that may or may not occur in the future and may cause the actual results,
performance or achievements to be materially different from those
expressed or implied by such forward-looking statements, and actual
results could differ materially from those currently anticipated due to
a number of risks and uncertainties. These statements are not guarantees
of future performance or the ability to identify and consummate
investments. Many of these risks and uncertainties relate to factors
that are beyond each of Amryt's and Chiasma's ability to control or
estimate precisely, such as future market conditions, the course of the
COVID-19 pandemic, currency fluctuations, the behaviour of other market
participants, the outcome of clinical trials, the actions of regulators
and other factors such as Amryt's ability to obtain financing, changes
in the political, social and regulatory framework in which Amryt
operates or in economic, technological or consumer trends or conditions.
Forward-looking statements in this communication include, without
limitation, statements about the anticipated benefits of the
contemplated transaction, including future financial and operating
results and expected synergies related to the contemplated transaction,
the plans, objectives, expectations and intentions of Amryt, Chiasma or
the combined company and the expected timing of the completion of the
contemplated transaction. Risks and uncertainties that could cause
results to differ from expectations include: uncertainties as to the
timing of the contemplated transaction; uncertainties as to the
approvals by Amryt's shareholders of Chiasma's stockholders required in
connection with the contemplated transaction; the possibility that a
competing proposal will be made; the possibility that the closing
conditions to the contemplated transaction may not be satisfied or
waived, including that a governmental entity may prohibit, delay or
refuse to grant a necessary regulatory approval; the effects of
disruption caused by the announcement of the contemplated transaction
making it more difficult to maintain relationships with employees,
customers, vendors and other business partners; the risk that
stockholder litigation in connection with the contemplated transaction
may affect the timing or occurrence of the contemplated transaction or
result in significant costs of defense, indemnification and liability;
other business effects, including the effects of industry, economic or
political conditions outside of the control of the parties to the
contemplated transaction; transaction costs; actual or contingent
liabilities; disruptions to the financial or capital markets; and other
risks and uncertainties discussed in Amryt's and Chiasma's respective
filings with the U.S. Securities and Exchange Commission (the "SEC").
You can obtain copies of Amryt's and Chiasma's respective filings with
the SEC for free at the SEC's website (www.sec.gov). Past performance
should not be taken as an indication or guarantee of future results, and
no representation or warranty, express or implied, is made regarding
future performance. No person is under any obligation to update or keep
current the information contained in this announcement or to provide the
recipient of it with access to any additional relevant information that
may arise in connection with it. Such forward-looking statements reflect
the Company's current beliefs and assumptions and are based on
information currently available to management.
Important Additional Information and Where to Find It
In connection with the proposed acquisition, Amryt intends to file a
registration statement on Form F-4 with the SEC, which will include a
document that serves as a prospectus of Amryt and a proxy statement of
Chiasma (the "proxy statement/prospectus"), Chiasma intends to file a
proxy statement with the SEC (the "proxy statement") and each party will
file other documents regarding the proposed acquisition with the SEC.
Investors and security holders are urged to carefully read the entire
registration statement and proxy statement/prospectus or proxy statement
and other relevant documents filed with the SEC when they become
available because they will contain important information. A proxy
statement/prospectus or a proxy statement when available will be sent to
Chiasma's shareholders. Investors and security holders will be able to
obtain the registration statement and the proxy statement/prospectus or
the proxy statement free of charge from the SEC's website or from Amryt
or Chiasma as described in the paragraphs below.
Neither this announcement nor any copy of it may be taken or transmitted
directly or indirectly into or from any jurisdiction where to do so
would constitute a violation of the relevant laws or regulations of such
jurisdiction. Any failure to comply with this restriction may constitute
a violation of such laws or regulations. Persons in possession of this
announcement or other information referred to herein should inform
themselves about, and observe, any restrictions in such laws or
regulations.
This announcement has been prepared for the purpose of complying with
the applicable law and regulation of the United Kingdom and the United
States and information disclosed may not be the same as that which would
have been disclosed if this announcement had been prepared in accordance
with the laws and regulations of jurisdictions outside the United
Kingdom or the United States.
No Offer or Solicitation
This communication is not intended to and does not constitute an offer
to sell or the solicitation of an offer to subscribe for or buy or an
invitation to purchase or subscribe for any securities or the
solicitation of any vote or approval in any jurisdiction, nor shall
there be any sale, issuance or transfer of securities in any
jurisdiction in contravention of applicable law.
Participants in the Solicitation
Amryt, Chiasma and certain of their respective directors, executive
officers and employees may be deemed participants in the solicitation of
proxies from Chiasma shareholders in connection with the proposed
transaction. Information regarding the persons who may, under the rules
of the SEC, be deemed participants in the solicitation of the
shareholders of Chiasma in connection with the proposed transaction,
including a description of their direct or indirect interests, by
security holdings or otherwise, will be set forth in the proxy
statement/prospectus or proxy statement when it is filed with the SEC.
Information about the directors and executive officers of Chiasma and
their ownership of Chiasma shares is set forth in the definitive proxy
statement for Chiasma's 2021 annual meeting of shareholders, as
previously filed with the SEC on April 26, 2021. Free copies of these
documents may be obtained as described in the paragraphs above.
Contacts
Joe Wiley, CEO / Rory Nealon, CFO/COO, +353 (1) 518 0200,
ir@amrytpharma.com
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Edward Mansfield, Shore Capital, NOMAD, +44 (0) 207 468 7906,
edward.mansfield@shorecap.co.uk
Tim McCarthy, LifeSci Advisors, LLC, +1 (212) 915 2564,
tim@lifesciadvisors.com
Amber Fennell, Consilium Strategic Communications, +44 (0) 203 709 5700,
fennell@consilium-comms.com
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(END) Dow Jones Newswires
May 05, 2021 07:00 ET (11:00 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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