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Amryt (Nasdaq: AMYT, AIM: AMYT) will release its Q3 2021 financial results on November 3, 2021 at 7:00 EDT / 11:00 GMT. A conference call and webcast for analysts and investors will follow at 8:30 EDT / 12:30 GMT on the same day. Interested parties can access the webcast here. Playback facilities will be available from November 3 to November 10, 2021. The call will cover the financial performance and strategic updates concerning their treatments for rare diseases.
Amryt has announced the issuance of new patents for its products Oleogel-S10 and Mycapssa®. The USPTO granted a formulation patent for Oleogel-S10, extending its potential patent protection until January 2039, pending FDA approval. This adds to three existing patents, totaling four for Oleogel-S10. Additionally, a new patent for Mycapssa® covering administration methods will protect it until December 2040, increasing its patent count to eight. These developments enhance Amryt's intellectual property portfolio, vital for its growth in the biopharmaceutical market.
Amryt (Nasdaq: AMYT) announced that as of September 30, 2021, its issued share capital consisted of 316,904,642 ordinary shares. The company does not hold any shares in treasury, resulting in this same number as the total voting rights.
This information is crucial for shareholders to determine their reporting obligations under FCA’s Disclosure Guidance and Transparency Rules.
Amryt focuses on developing treatments for rare diseases, with ongoing products and promising candidates like Oleogel-S10, which is under FDA priority review.
Amryt Raises Full Year 2021 Revenue Guidance to $220M - $225M
Amryt, a biopharmaceutical company, has increased its FY 2021 revenue guidance from $210M-$215M to $220M-$225M, reflecting a 20%-23% year-over-year growth. This revision follows the recent acquisition of Chiasma, Inc. and positive performance of its commercial products. The company will host a virtual capital markets event discussing growth plans, focusing on Mycapssa® and Oleogel-S10. The PDUFA date for Oleogel-S10 is set for November 30, 2021, with the EMA also reviewing the product.
Amryt announces that as of August 31, 2021, its total issued share capital comprises 316,496,087 ordinary shares. No shares are held in treasury, leading to the total number of voting rights also being 316,496,087. This figure is essential for shareholders to determine any required notifications under the FCA’s Disclosure Guidance and Transparency Rules.
Amryt focuses on developing treatments for rare diseases and has several approved products including Myalept, Mycapssa, and Juxtapid. The company is also awaiting FDA approval for its lead candidate, Oleogel-S10 (Filsuvez), with a PDUFA date set for November 30, 2021.
Amryt announced the issuance of 7,015 new ordinary shares following its acquisition of Chiasma on August 5, 2021. These Consideration Shares will be allotted to former Chiasma shareholders in tradeable form. The total issued share capital will reach 316,092,197 ordinary shares, equating to 63,218,439 ADSs. This update affects the voting rights calculation for shareholders. The Consideration Shares are set for admission to AIM on August 20, 2021, reinforcing Amryt's commitment to developing treatments for rare diseases.
Amryt (Nasdaq: AMYT) announced on August 9, 2021, the granting of stock options to various Non-Executive Directors as part of its Equity Incentive Plan. Key awards include 110,000 shares to Chairman Raymond T. Stafford and 220,000 shares to Non-Executive Director Rajkumar Kannan. The exercise price for these options is set at $2.04 per ordinary share. Amryt focuses on developing treatments for rare diseases, with its commercial portfolio including three orphan disease products. The announcement reflects ongoing commitment to incentivizing leadership while aligning interests with shareholders.
Amryt (Nasdaq: AMYT) will host a Virtual Capital Markets Event on September 13, 2021, from 10:00 to 12:00 EDT. The event will cover Amryt's long-term strategy, market opportunities for its products, and growth plans for Mycapssa®, the first FDA-approved oral somatostatin analog for acromegaly. Additionally, updates on Oleogel-S10, a treatment for Epidermolysis Bullosa (EB), will be presented, along with a discussion on its regulatory pathway. Leading KOL Dr. Maria Fleseriu will discuss the treatment landscape in acromegaly.
Amryt reported record Q2 2021 results with revenue of $62.8M, marking a 35.9% increase year-over-year. The company raised its full-year revenue guidance to $210M-$215M, reflecting strong growth expectations.
Notably, EBITDA reached $17.4M, a significant increase of 152% compared to Q2 2020. Amryt completed the acquisition of Chiasma and received FDA priority review for Oleogel-S10, a potential treatment for severe EB with a PDUFA target date set for November 30, 2021. Cash reserves increased to $142.9M as of June 30, 2021, supporting ongoing business expansion.
Amryt has successfully completed the acquisition of Chiasma, Inc. after receiving necessary shareholder approvals. This strategic move enhances Amryt's position in the biopharmaceutical market, adding three approved commercial products and an exciting pipeline, including Oleogel-S10, which is under regulatory review. The acquisition also led to new board appointments, with Raj Kannan and Roni Mamluk joining as Non-Executive Directors. Amryt has issued 127,733,680 new ordinary shares as part of the transaction and aims for further share admissions on AIM.