Pharming N.V.(PHAR) - 2021 Q4 - Annual Report

SEC Filing Information Filing Details This section identifies the filing as a Form 6-K for Pharming Group N.V. for April 2022, indicating its status as a foreign private issuer filing under Form 20-F - Pharming Group N.V. filed a Form 6-K for April 2022 as a foreign private issuer under Form 20-F[1][2] Exhibit Index The exhibit index specifies that a press release announcing the filing of the 2021 Annual Report and Form 20-F, and the convening of the 2022 AGM, is filed as Exhibit 99.1 - Exhibit 99.1 is a press release announcing the filing of the 2021 Annual Report, Form 20-F, and the 2022 AGM[4][6] Signature The report is officially signed by Sijmen de Vries, CEO of Pharming Group N.V., on April 7, 2021 - The report was signed by Sijmen de Vries, CEO of Pharming Group N.V., on April 7, 2021[7][9] Company Announcement Filing of 2021 Annual Report and Form 20-F Pharming Group N.V. announced the filing of its Annual Report for the year ended December 31, 2021, and its Form 20-F with the U.S. SEC, making both documents available on the company's website - Pharming Group N.V. filed its 2021 Annual Report and Form 20-F with the U.S. SEC for the period ended December 31, 2021[10] - The Annual Report and Form 20-F are available on the Company's website under Investors/Financial Documents and Investors/SEC filings, respectively[11] Convening of 2022 Annual General Meeting (AGM) The company announced its 2022 Annual General Meeting (AGM) will be held on Wednesday, May 18, 2022, at 2:00 pm (CEST), with all relevant meeting documents available on its website - The 2022 Annual General Meeting (AGM) is scheduled for Wednesday, May 18, 2022, at 2:00 pm (CEST)[11] - Meeting documents, including the Notice to Convene, Explanatory Notes, and Form of Proxy, are available on the company's website[11] About Pharming Group N.V. Company Overview Pharming Group N.V. is a global, commercial-stage biopharmaceutical company dedicated to developing innovative protein replacement therapies and precision medicines for rare diseases and unmet medical needs - Pharming Group N.V. is a global, commercial-stage biopharmaceutical company[12] - The company focuses on developing innovative protein replacement therapies and precision medicines for rare diseases and unmet medical needs[12] Product Portfolio and Pipeline Pharming's portfolio is anchored by its recombinant human C1 esterase inhibitor (rhC1INH) franchise, including RUCONEST®, and a pipeline featuring leniolisib for APDS, a strategic collaboration for OTL-105, and preclinical development for Pompe disease RUCONEST® (rhC1INH) Franchise RUCONEST® is a plasma-free recombinant human C1 esterase inhibitor approved for acute hereditary angioedema attacks, with ongoing investigations for additional indications - RUCONEST® is the first and only plasma-free recombinant human C1 esterase inhibitor (rhC1INH) protein replacement therapy[13] - It is approved for the treatment of acute hereditary angioedema (HAE) attacks and commercialized in the US, EU, UK, and other regions[13] - Pharming is investigating rhC1INH for additional indications, including pre-eclampsia, acute kidney injury, and severe pneumonia from COVID-19[14] Leniolisib (PI3K delta inhibitor) Leniolisib, an oral PI3K delta inhibitor, is under study for activated PI3K delta syndrome (APDS), having met primary endpoints in a Phase 2/3 study, with global regulatory filings targeted from Q2 2022 - Leniolisib, an oral phosphoinositide 3-kinase delta (PI3K delta) inhibitor, is being studied for activated PI3K delta syndrome (APDS)[15] - Leniolisib met both primary endpoints in a registration-enabling Phase 2/3 study in the US and Europe[15] - Global regulatory filings for leniolisib are targeted from Q2 2022 onwards[15] Strategic Collaborations and Next-Generation Therapies Pharming collaborates with Orchard Therapeutics on OTL-105 for HAE and develops next-generation protein replacement therapies, including a preclinical program for Pompe disease - Pharming collaborates with Orchard Therapeutics on OTL-105, an ex-vivo autologous hematopoietic stem cell (HSC) gene therapy for HAE[16] - The company is developing next-generation protein replacement therapies using its transgenic manufacturing technology, including a preclinical program for Pompe disease[17] Disclaimers and Contact Information Forward-looking Statements This section outlines standard disclaimers regarding forward-looking statements, covering risks and uncertainties related to clinical trials, commercial prospects, COVID-19, and financial resources - The press release contains forward-looking statements regarding clinical trials, commercial prospects, COVID-19 impact, and financial requirements[18] - These statements are subject to risks and uncertainties described in Pharming's 2021 Annual Report and Form 20-F[18] Inside Information and Contacts This section notes the press release may contain inside information under EU Market Abuse Regulation and provides contact details for company executives and external PR consultants - The press release may contain inside information as per Article 7(1) of the EU Market Abuse Regulation[19] - Contact information is provided for Pharming Group's CEO, Investor Relations Manager, and FTI Consulting (London/USA) and LifeSpring Life Sciences Communication (Amsterdam) for public inquiries[19]