GCIAmryt Pharma unveils merger with Chiasma
announced on Wednesday that it has signed a definitive agreement to acquire biopharmaceutical firm Chiasma, Inc. (Nasdaq: CHMA) in an all-stock combination.
The company outlined that the combined entity group will operate 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.
Amryt said it has in place the infrastructure, expertise and the financial flexibility to realize the full global potential of MYCAPSSA® and to expand the product’s benefits into other markets.
MYCAPSSA® is the first and only oral somatostatin analog (“SSA”) approved for appropriate patients with acromegaly in a global market estimated at around $800m with the potential to expand into the neuroendocrine tumor (“NET”) market estimated at around $1.9bn globally.
Amryt highlighted to investors that it believes today’s acquisition leverages the company’s proven commercial execution ability, global infrastructure and integration capabilities to push the MYCAPSSA®’s launch across the United States as well as in other international markets.
“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®, 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,” said Amryt’s CEO, Dr. Joe Wiley.
He added that, “The combined business will have three approved commercial products and an exciting pipeline of development assets.” Meanwhile, Amryt’s lead development candidate, Oleogel-S10, is currently progressing through the regulatory process in the US and EU and, if approved, is expected to bring the company’s portfolio of commercial products to four.
Amryt said it sees significant revenue growth opportunities for MYCAPSSA® in acromegaly and that it is excited to further develop MYCAPSSA®’s potential in patients with carcinoid symptoms stemming from NET where it believes the commercial opportunity is significant.
In a separate statement, Amryt Pharma published its unaudited financial results for the quarter ended 31 March 2021 in which it stated that the group had seen a record quarter.
The Company posted 8.7% revenue growth in 1Q21 to $48.4m (1Q20: $44.6m), representing a 13.9% increase in revenues on 4Q20 as well as “the continued positive momentum and growth” it is experiencing in its business across its two commercial products globally, it said.
“Q1 was extremely busy and we delivered a number of commercial and regulatory successes during the quarter. Our two commercial products, metreleptin and lomitapide, continue to deliver solid growth across a host of metrics including revenue, EBITDA growth, cash generation and market expansion. Our EBITDA has increased 115% compared to the same quarter in 2020,” commented Joe Wiley, CEO of Amryt Pharma on the results for the quarter.
As a result of the strong performance during the quarter, it has increased its revenue guidance for 2021 from $200-$205m to $205-$210m excluding any potential contribution from the proposed Chiasma transaction, which represents growth of between 12% -15% on 2020.
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Today, the Company described its proposed acquisition of Chiasma as “a transformational deal” that can pave a path to a combined potential $1 billion peak revenue for Amryt.
Amryt believes the proposed transaction will leverage its track record of successful integration as well as significantly enhance its future growth plans in highly attractive markets globally.
Shares in Amryt have increased by 8% since the beginning of 2021. The stock was trading 7.50% lower on Wednesday afternoon at 185p following this morning’s announcement.
Reasons to AMYT
Amryt is a biopharmaceutical company focused on developing and delivering innovative new 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.
Leading Portfolio
AMYT’s portfolio includes Amryt's lead development candidate, FILSUVEZ®, a potential treatment for the cutaneous manifestations of EB, a rare and distressing genetic skin disorder affecting young children and adults for which there is currently no approved treatment.
Amryt continues to grow its existing commercial products while it is currently preparing for the launch of its FILSUVEZ® skin product in the US in 4Q21 and in Europe in 1Q22.
The anticipated launch of FILSUVEZ® follows recent positive results from Amryt’s Phase 3 EASE trial, the largest ever global Phase 3 trial conducted in patients with genetic skin disorder Epidermolysis Bullosa (EB), which was performed across 58 sites in 28 countries.
Amryt now intends to complete the submission of its rolling New Drug Application (“NDA”) to the US Food and Drug Administration (“FDA”) and request priority review for FILSUVEZ®.
In a recent report, CEO,Wiley, highlighted the group’s products metreleptin and lomitapide as delivering growth across revenue, EBITDA, cash generation and market expansion.
Amyrt’s Myalept® / Myalepta® injection is a leptin replacement therapy used with a doctor-recommended diet to treat problems caused by not having enough leptin in the body. It is approved in the US under the trade name Myalept® and in the EU under Myalepta®.
Juxtapid®/ Lojuxta® (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, Columbia, Argentina and Japan under the trade name Juxtapid® and in the EU under the trade name Lojuxta®.
Expanding Distribution Capacity
Amyrt recently signed a distribution agreement with Swixx BioPharma AG (“Swixx”), a Swiss pharmaceutical agent operating in Central and Eastern Europe (“CEE”) for Lojuxta®.
The agreement represents new territories for the Group to further accelerate its revenue growth, augmenting sales already being generated through its existing salesforce in the EU.
In recent weeks, Amryt received approval from the National Institute for Health and Care Excellence (“NICE”) for its leptin replacement therapy Myalepta® (metreleptin) in England and Wales, to treat partial and generalised lipodystrophy in adults and children 12+ years of age.
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