Full Press Release Details
Galapagos announces first half-year 2023 financial results
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
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 performance
GLPG5101 in relapsed/refractory non-Hodgkin s lymphoma (rrNHL)
GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (rrCLL), with or without
Richter s transformation (RT)
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&A ii and S&M iii 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 results
Total 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.
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.
Business development
First half-year 2023 financial report
Galapagos 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 presentation
We 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 | Third quarter 2023 results | (webcast 3 November 2023) | ||
| 22 February 2024 | Full year 2023 results | (webcast 23 February 2024) |
Galapagos 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
| Contact | ||
| Media inquiries: | Investor inquiries: | |
| Marieke Vermeersch | Sofie Van Gijsel | |
| +32 479 490 603 | +1 781 296 1143 | |
| media@glpg.com | ir@glpg.com | |
| Sandra Cauwenberghs | ||
| +32 495 58 46 63 | ||
| ir@glpg.com |
Forward-looking statements
This 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.
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