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Galapagos(GLPG) - 2023 Q1 - Quarterly Report
2023-03-31 10:05
Strategic Collaboration - Galapagos NV and NovAliX announced a strategic collaboration involving the transfer of Galapagos' drug discovery and research activities in Romainville, France[2]. - The collaboration is part of Galapagos' strategic reorientation towards a fit-for-purpose R&D organization, focusing on oncology and immunology[2]. - The collaboration aims to accelerate innovation, reduce risks, and shorten drug development timelines[2]. - The strategic partnership reflects the evolving landscape of the biopharmaceutical industry, emphasizing new collaboration models between CROs and biopharmaceutical companies[4]. Financial Impact - The financial impact of the transaction is included in Galapagos' previously announced 2023 cash burn guidance, estimated to be between €380 million and €420 million[3]. - The transaction is expected to close in July 2023, subject to customary closing conditions[3]. Drug Discovery Enhancement - The acquisition will allow NovAliX to enhance its drug discovery capabilities, particularly in kidney diseases, fibrosis, and immunology, complementing its existing expertise in oncology and infectious diseases[4]. - NovAliX's acquisition includes a highly skilled team from Galapagos, enhancing its DNA-Encoded Libraries database and cryo-EM driven discovery engine[4]. - Galapagos retains the flexibility to access NovAliX's research capabilities through a five-year collaboration agreement[6]. Commitment to Medical Needs - Galapagos' first medicine for rheumatoid arthritis and ulcerative colitis is already available in Europe and Japan, indicating its commitment to addressing high unmet medical needs[5].
Galapagos(GLPG) - 2022 Q4 - Annual Report
2023-03-23 20:02
Product Dependence - The company reported a significant reliance on the success of filgotinib, which is approved for rheumatoid arthritis and ulcerative colitis in the EU, Great Britain, and Japan, marketed under the brand name Jyseleca[23]. - The company is heavily dependent on its global R&D collaboration with Gilead for the commercialization and development of filgotinib, with no assurance of expected benefits[20]. Financial Challenges - The company has no historical profit from product sales, making it challenging to assess future prospects and financial results[21]. - The company is prioritizing the development of certain product candidates due to limited resources and access to capital[26]. - The company may be subject to ongoing regulatory obligations and reviews, resulting in significant additional expenses if product candidates are approved[29]. Market and Competition - The company faces significant competition in drug discovery and development, which could reduce or eliminate commercial opportunities[31]. - The regulatory approval processes for product candidates are lengthy and unpredictable, which may affect commercial viability[27]. Investment and Infrastructure - The company is investing in building its marketing and sales capabilities to establish a European commercial infrastructure[22]. Market Risks - The market price of the company's American Depositary Shares (ADSs) could experience wide fluctuations[33]. - The company may face increased risks of securities class action litigation[34].
Galapagos(GLPG) - 2022 Q4 - Annual Report
2023-03-23 10:28
EXHIBIT 99.1 Galapagos increases share capital through subscription right exercises Mechelen, Belgium; 20 March 2023, 21.01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) announces a share capital increase arising from subscription right exercises. Galapagos issued 61,560 new ordinary shares on 20 March 2023, for a total capital increase (including issuance premium) of EUR 1,769,850.00. In accordance with Belgian transparency legislation, Galapagos also wishes to note that its total sha ...
Galapagos(GLPG) - 2022 Q4 - Earnings Call Transcript
2023-02-24 15:35
Galapagos NV (NASDAQ:GLPG) Q4 2022 Earnings Conference Call February 24, 2023 8:00 AM ET Company Participants Sofie Van Gijsel - Senior Director of Investor Relations Paul Stoffels - Chief Executive Officer Bart Filius - Chief Operating Officer & President Daniele D’Ambrosio - Head of Immunology Michele Manto - Chief Commercial Officer Conference Call Participants Phil Nadeau - Cowen Peter Verdult - Citi Brian Abrahams - RBC Capital Markets Rosie Turner - Jefferies Dane Leone - Raymond James Suzanne van Voo ...
Galapagos(GLPG) - 2022 Q2 - Earnings Call Transcript
2022-08-06 09:30
Galapagos NV (NASDAQ:GLPG) Q2 2022 Earnings Conference Call August 5, 2022 8:00 AM ET Company Participants Sofie Van Gijsel - Senior Director of Investor Relations Paul Stoffels - Chief Executive Officer Bart Filius - Chief Operating Officer & Chief Financial Officer Walid Abi-Saab - Chief Medical Officer Michele Manto - Chief Commercial Officer Conference Call Participants Brian Abrahams - RBC Capital Markets Jason Gerberry - Bank of America Charlie Mabbutt - Bernstein James Gordon - JPMorgan Matthew Harri ...
Galapagos(GLPG) - 2022 Q1 - Earnings Call Presentation
2022-05-06 16:38
| --- | --- | |---------------------|-------| | | | | | | | 1Q 2022 results | | | May 6, 2022 webcast | | | | | This presentation contains "forward-looking statements." When used in this presentation, the words "anticipate," "could," "expect," "will," "plan," "potential," "estimate," "on track," "guidance," "ongoing," "outlook," and similar expressions are intended to identify forward-looking statements. These statements include, but are not limited to, statements regarding: the rate and timing of our cash ...
Galapagos(GLPG) - 2022 Q1 - Earnings Call Transcript
2022-05-06 16:16
Financial Data and Key Metrics Changes - The company reported a cash position of EUR 4.6 billion at the end of March 2022, with an operational cash burn of EUR 77 million for the quarter, which is below the expected 25% of the annual guidance of EUR 450 million to EUR 490 million [30][31][32] - Revenue recognition included EUR 14 million from Jyseleca sales and EUR 5 million in royalties related to its performance in Japan [31][32] Business Line Data and Key Metrics Changes - Jyseleca sales in rheumatoid arthritis (RA) reached EUR 14.4 million in Q1 2022, with a confirmed guidance of EUR 65 million to EUR 75 million for the year [22][23] - The market share of JAK inhibitors in Europe is approaching 20%, with Jyseleca's market share in the EU5 countries nearing 5% [24][25] Market Data and Key Metrics Changes - The company is expanding its market presence in Eastern Europe and Portugal through its partner Sobi, which is expected to enhance sales further [22][26] - The total market for ulcerative colitis (UC) is estimated to be around EUR 1 billion, with Jyseleca showing good reception in the markets where it is available [27] Company Strategy and Development Direction - The company aims to focus on high unmet medical needs and will gradually shift from first-in-class to best-in-class targets, accelerating the pipeline towards proof of concept [12][56] - There is an emphasis on smaller select acquisitions or licensing deals rather than large acquisitions, with a focus on late preclinical and early Phase I assets [14][15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong balance sheet and the potential for significant transformation of the pipeline, with plans to bring multiple new opportunities to the clinic [11][34] - The company is optimistic about the future growth potential, with a focus on leveraging its capabilities in R&D and commercial operations [34][70] Other Important Information - The company has a deferred revenue balance of EUR 2.3 billion, indicating substantial future revenue potential from its current projects [31] - The company is actively evaluating opportunities for collaboration and licensing, particularly in light of the current market environment [67][74] Q&A Session Summary Question: Thoughts on late-stage versus early-stage programs - The focus is on early-stage assets, particularly Phase I/II, while late-stage assets are considered but with less emphasis due to high costs and limited added value [38] Question: Acquisition strategy and cash balance - The company is open to both using its cash balance for acquisitions and collaborating with Gilead for larger assets, emphasizing flexibility in their approach [41][42] Question: R&D strategy and unmet needs - The company plans to prioritize areas with high unmet medical needs and improve the derisking of programs before moving to large Phase III trials [55][56] Question: Interest in commercial rights for approved drugs - The company is open to partnering with U.S. biotech firms for commercial rights in Europe, leveraging its established commercial infrastructure [62] Question: Current business development environment - The market pullback has created opportunities for the company to engage with firms that have promising science but lack funding [67] Question: Attractiveness as a partner for smaller companies - The company offers agility and flexibility, making it an attractive partner for smaller firms looking to maintain involvement in their projects [74]
Galapagos(GLPG) - 2021 Q4 - Annual Report
2022-03-24 20:04
Financial Performance and Prospects - Galapagos has no historical product revenues, making it difficult to assess future prospects and financial results[21]. - The company has prioritized the development of certain product candidates due to limited resources and access to capital[26]. - The COVID-19 pandemic could materially and adversely affect the company's business and future growth prospects[34]. Product Development and Regulatory Challenges - The company is heavily dependent on the success of filgotinib, which is approved for rheumatoid arthritis and ulcerative colitis in the EU and Great Britain[23]. - Regulatory approval processes for product candidates are lengthy and unpredictable, impacting commercial viability[27]. - Future clinical trials may reveal significant adverse events that could inhibit regulatory approval or market acceptance[31]. Market and Competitive Landscape - Galapagos is currently building a marketing and sales organization to establish a European commercial infrastructure[22]. - Coverage and reimbursement decisions by third-party payers may adversely affect pricing and market acceptance of approved products[32]. - The company faces significant competition in drug discovery and development efforts, which could reduce commercial opportunities[32]. - The market price of the American Depositary Shares (ADSs) could be subject to wide fluctuations[35].
Galapagos(GLPG) - 2021 Q4 - Annual Report
2022-03-24 13:51
Compliance and Regulatory Filings - The registrant filed Form 20-F for annual reports, indicating compliance with SEC regulations[2] - The report includes information relevant to the registrant's securities and compliance with home country laws[3] Performance Information - The press release dated March 18, 2022, is attached as Exhibit 99.1, providing further details on the company's performance[5]
Galapagos(GLPG) - 2021 Q4 - Earnings Call Transcript
2022-02-25 17:48
Galapagos NV (NASDAQ:GLPG) Q4 2021 Earnings Conference Call February 25, 2022 8:00 AM ET Company Participants Sofie Van Gijsel - Senior Director, Investor Relations Onno van de Stolpe - Chief Executive Officer Bart Filius - Chief Operating Officer Walid Abi-Saab - Chief Medical Officer Michele Manto - Chief Commercial Officer Conference Call Participants Jason Gerberry - Bank of America Dane Leone - Raymond James Peter Verdult - Citigroup Brian Abrahams - RBC Capital Markets Laura Sutcliffe - UBS Philip ...