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Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
---|---|---|---|---|---|
Galapagos | LSE:GLPG | London | Ordinary Share | BE0003818359 | ORD SHS NO NOMINAL VALUE |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
0.00 | 0.00% | 416.00 | 0.00 | 01:00:00 |
Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
---|---|---|---|---|---|
0 | 0 | N/A | 0 |
Webcast presentation tomorrow, 4 August 2023, at 14:00 CET / 8:00 am ET, www.glpg.com
Mechelen, Belgium; 3 August 2023, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first half-year 2023 financial results, a year-to-date business update and its outlook for the remainder of 2023. The results are further detailed in the H1 2023 financial report available on the financial reports section of the corporate website.
“The market and competitive landscape for the JAK class in Europe has changed significantly over the past six months, negatively impacting net sales of Jyseleca® and leading us to revise our 2023 net sales guidance for Jyseleca® in rheumatoid arthritis and ulcerative colitis from €140-€160 million to €100-€120 million. In response to that, we are in the process of evaluating various strategic options for Jyseleca®. We have a strong cash position of €3.9 billion and we will continue to deploy our resources in our strategic areas of immunology and oncology, including externally sourced innovative product candidates, to further build and expand our portfolio. Despite lower than anticipated net sales for Jyseleca®, we reiterate our cash burn guidance of €380-€420 million,” said Thad Huston, CFO and COO of Galapagos.
Dr. Paul Stoffels1, CEO and Chairman of Galapagos added: “Our commitment to providing transformational medicines to patients worldwide remains our core focus. We have successfully implemented our R&D strategy focused on best-in-class medicines to accelerate innovation, aiming to generate short and long-term value for all our stakeholders. We are actively building a differentiated discovery pipeline of best-in-class small molecules, CAR-T cell therapies and biologicals in our core areas of immunology and oncology. In addition, our ongoing clinical programs across our therapeutic areas are progressing well, and we are optimistic about the global potential of our point-of-care CAR-T cell therapy portfolio in hematological malignancies. Furthermore, in immunology, we have continued to expand our clinical pipeline of small molecules, while leveraging our CAR-T capabilities to start clinical development in refractory systemic lupus erythematosus with a CD19 CAR-T candidate.”
Half-Year 2023 operational performanceImmunology portfolio
Oncology portfolio
Corporate update
First half-year 2023 financial highlights (unaudited) (€ millions, except basic & diluted income/loss (-) per share)
Six months ended 30 June | Change | ||
2023 | 2022 | ||
Product net sales | 54.3 | 35.4 | +54% |
Collaboration revenues | 274.5 | 238.6 | +15% |
Total net revenues | 328.8 | 274.0 | +20% |
Cost of sales | (7.8) | (5.5) | +41% |
R&D expenditure | (211.9) | (249.5) | -15% |
G&Aii and S&Miii expenses | (121.6) | (134.0) | -9% |
Other operating income | 23.8 | 17.6 | +35% |
Operating profit/loss (-) | 11.3 | (97.5) | |
Fair value adjustments and net currency exchange differences | 0.2 | 71.9 | |
Net other financial result | 30.4 | (4.3) | |
Income taxes | (13.6) | (2.5) | |
Net profit/loss (-) of the period | 28.3 | (32.3) | |
Basic and diluted income/loss (-) per share (€) | 0.43 | (0.49) | |
Current financial investments and cash and cash equivalents | 3,874.9 | 4,429.0 |
Details of the first half-year 2023 financial resultsTotal net revenues for the six months ended 30 June 2023 was €328.8 million, compared to €274.0 million for the six months ended 30 June 2022, and consisted of:
Collaboration revenues increased mainly due to revenue recognition related to the collaboration agreement with Gilead for the filgotinib development amounting to €154.9 million in the first six months of 2023 compared to €115.3 million for the same period last year. This increase is primarily driven by a positive catch up of revenue explained by a decrease in the total estimated remaining costs to complete the filgotinib development. This was a consequence of the topline results from Phase 3 DIVERSITY trial of filgotinib in CD and our decision not to submit a Marketing Authorization Application in Europe.
Our deferred income balance on 30 June 2023 includes €1.4 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and €0.3 billion allocated to the filgotinib development that is recognized over time until the end of the development period.
Total operating profit for the six months ended 30 June 2023 was €11.3 million, compared to total operating loss of €97.5 million for the first six months ended 30 June 2022.
Net financial income in the first six months of 2023 amounted to €30.6 million, compared to net financial income of €67.7 million for the first six months of 2022.
We reported a group net profit for the first six months of 2023 of €28.3 million, compared to a group net loss of €32.3 million for the first six months of 2022.
Cash position Current financial investments and cash and cash equivalents totaled €3,874.9 million on 30 June 2023, as compared to €4,094.1 million on 31 December 2022.
Total net decrease in cash and cash equivalents and current financial investments amounted to €219.1 million during the first six months of 2023, compared to a net decrease of €274.2 million during the first six months of 2022. This net decrease was composed of (i) €224.3 million of operational cash burn, (ii) €9.3 million of mainly negative exchange rate differences, offset by (iii) €1.8 million of cash proceeds from capital and share premium increase from exercise of subscription rights in the first six months of 2023, and (iv) €12.7 million positive changes in (fair) value of current financial investments.
Outlook 2023Financial outlook
R&D outlook
Business development
First half-year 2023 financial reportGalapagos’ financial report for the first six months ended 30 June 2023, including details of the unaudited consolidated results, is accessible on the financial reports section of our website.
Conference call and webcast presentationWe will host a conference call and webcast presentation tomorrow 4 August 2023, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link, after which the dial-in numbers will be provided. The conference call can be accessed 10 minutes prior to the start by using the conference access information provided in the email after registration, or by selecting the “call me” feature.
The live webcast is available on glpg.com or via the following link. The archived webcast will be available for replay shortly after the close of the call on the investor section of the website.
Financial calendar 2023
2 November 2023 22 February 2024 | Third quarter 2023 results Full year 2023 results | (webcast 3 November 2023) (webcast 23 February 2024) |
About GalapagosGalapagos is a fully integrated biotechnology company united around a single purpose: to transform patient outcomes through life-changing science and innovation for more years of life and quality of life. We focus on the key therapeutic areas of immunology and oncology, where we have developed deep scientific expertise in multiple drug modalities, including small molecules and cell therapies. Our portfolio comprises discovery through to commercialized programs and our first medicine for rheumatoid arthritis and ulcerative colitis is currently available in Europe and Japan. For additional information, please visit www.glpg.com or follow us on LinkedIn or Twitter.
Contact
Media inquiries: Marieke Vermeersch +32 479 490 603 media@glpg.com | Investor inquiries: Sofie Van Gijsel +1 781 296 1143ir@glpg.com Sandra Cauwenberghs +32 495 58 46 63 ir@glpg.com |
Forward-looking statementsThis release may contain forward-looking statements, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipate,” “believe,” “progress,” “further,” “expect,” “encouraging,” “long-term,” “plan,” “could,” “estimate,” “will,” “continue,” “aim,” “intend,” “future,” “guidance,” “outlook,” “progress,” “forward” as well as similar expressions. Forward-looking statements contained in this release include, but are not limited to, statements made in the sections captioned “Half-Year 2023 operational performance” and “Outlook 2023”, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash and adjusted net sales guidance for Jyseleca® during the financial year 2023), statements regarding our strategy and plans, including our strategic and capital allocation priorities, statements regarding the transfer of our drug and research activities and employees exclusively dedicated to the activities in Romainville (France), statements regarding the five year-collaboration between Galapagos and NovAliX, statements regarding the global R&D collaboration with Gilead, statements regarding the amount and timing of potential future milestones, and other payments, statements regarding our strategic R&D plans, including progress on our immunology or oncology portfolio, our CAR-T-portfolio and our SIKi-portfolio, and potential changes of such plans, statements regarding our pipeline and complementary technology platforms facilitating future growth, statements regarding the expected timing, design and readouts of ongoing and planned preclinical studies and clinical trials, including but not limited to (i) filgotinib in RA, UC and AxSpA, (ii) with SIKi compounds, including GLPG3667 in SLE and DM, (iii) GLPG5101 in rrNHL and rSLE, (iv) GLPG5201 in rrCLL and rrSLL, and (v) GLPG5301 in rrMM, including recruitment for trials and topline results for our trials and studies in our portfolio, statements relating to interactions with regulatory authorities, the timing or likelihood of additional regulatory authorities’ approval of marketing authorization for filgotinib for RA, UC or any other indication for filgotinib, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our future approved products, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), statements related to the EMA’s safety review of JAK inhibitors used to treat certain inflammatory disorders, including filgotinib, initiated at the request of the European Commission (EC) under Article 20 of Regulation (EC) No 726/2004 and regarding the related CHMP opinion and EC’s decision, statements regarding the timing or likelihood of pricing and reimbursement interactions for filgotinib, statements relating to the development of our commercial organization, statements and expectations regarding commercial sales for filgotinib, statements regarding our plans and strategy related to the development of our CD19 CAR-T candidates, GLPG5101 and GLPG5201, including patient enrollment for the Phase 1/2 ATALANTA-1 study and the EUPLAGIA-1 study, and the timing for topline results from such studies, statements regarding the timing for initiation of, the Phase 1/2 PAPILIO-1 study with BCMA CAR-T candidate, GLPG5301, statements regarding the timing and likelihood of business development projects and external innovation, and statements regarding the changes in our leadership and expected resulting benefits. Any forward-looking statements in this release are based on management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements to be materially different from any historic or future results, financial conditions and liquidity, performance or achievements expressed or implied by such forward-looking statements. Such risks include, but are not limited to, the risk that our expectations regarding our 2023 revenues, operating expenses, cash burn and other financial results may be incorrect (including because one or more of our assumptions underlying our revenue and expense expectations may not be realized), the risk that ongoing and future clinical trials may not be completed in the currently envisaged timelines or at all, the inherent risks and uncertainties associated with competitive developments, clinical trials, recruitment of patients, product development activities and regulatory approval requirements (including the risk that data from our ongoing and planned clinical research programs in RA, UC, DM, SLE, AxSpA, refractory/relapsed NHL, rrCLL, refractory/replapsed small lymphocytic lymphoma, rrMM and other immunologic indications or any other indications or diseases, may not support registration or further development of our product candidates due to safety or efficacy concerns or other reasons), risks related to the acquisitions of CellPoint and AboundBio, including the risk that we may not achieve the anticipated benefits of the acquisitions of CellPoint and AboundBio, risks related to the transfer of the drug discoveries and research activities conducted in Romainville (France) and employees exclusively dedicated to these activities to NovAliX, the inherent risks and uncertainties associated with target discovery and validation and drug discovery and development activities, the risk that the preliminary and topline data from the OLINGUITO, ATALANTA-1, EUPLAGIA-1, GALARISSO, PAPILIO-1, FILOSOPHY, and GALACELA-studies may not be reflective of the final data, risks related to our reliance on collaborations with third parties (including, but not limited to, our collaboration partner Gilead, Sobi and Lonza), risks related to the implementation of the transition of the European commercialization responsibility of filgotinib from Gilead to us, including the transfer of the supply chain, and the risk that the transition will not have the currently expected results for our business and results of operations, the risk that our plans with respect to our CAR-T programs may not be achieved on the currently anticipated timeline or at all, the risk that our estimates of the commercial potential of our product candidates or expectations regarding the costs and revenues associated with the commercialization rights may be inaccurate, the risk that we will not be able to continue to execute on our currently contemplated business plan and/or will revise our business plan, the risks related to our strategic transformation, including the risk that we may not achieve the anticipated benefits of such exercise on the currently envisaged timeline or at all, the risk that we will be unable to successfully achieve the anticipated benefits from our leadership transition, the risk that we will encounter challenges retaining or attracting talent, risks related to potential disruptions in our operations, supply chain or ongoing studies due to the conflict between Russia and Ukraine, the risk that the EMA may impose JAK class-based warnings, and the risk that the EMA’s safety review may negatively impact acceptance of filgotinib by patients, the medical community, and healthcare payors, the risk that regulatory authorities may require additional post-approval trials of filgotinib or any other product candidates that are approved in the future, and the risks and uncertainties relating to the impact of the COVID-19 pandemic. A further discussion of these risks, uncertainties and other risks can be found in our filings and reports with the Securities and Exchange Commission (SEC), including in our most recent annual report on Form 20-F filed with the SEC and other filings and reports filed by Galapagos with the SEC. Given these risks and uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. In addition, even if our results, performance, financial condition and liquidity, and the development of the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this release. We expressly disclaim any obligation to update any such forward-looking statements in this release unless required by law or regulation.
1 Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’2 Swedish Orphan Biovitrum AB3 Cut-off date for efficacy and safety analysis: 9 January 20234 As published in the press release of February 9, 2023: Galapagos presented encouraging initial safety and efficacy data at 2023 EBMTEHA for point-of-care manufactured CAR-T candidate, GLPG5201, in rrCLL5 CTA for GLPG5301 in BCMA was approved in May 2023
i The operational cash burn (or operational cash flow if this liquidity measure is positive) is equal to the increase or decrease in our cash and cash equivalents (excluding the effect of exchange rate differences on cash and cash equivalents), minus:
This alternative liquidity measure is in our view an important metric for a biotech company in the development stage. The operational cash burn for the six months ended 30 June 2023 amounted to €224.3 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €409.8 million, adjusted by (i) the cash proceeds from capital and share premium increase from the exercise of subscription rights by employees for €1.8 million, and (ii) the net purchase of current financial investments amounting to €187.2 million.ii General and administrative iii Sales and marketing
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1 Month Galapagos Chart |
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