02.11.2023 21:01:05 - dpa-AFX: GNW-Adhoc: Galapagos reports third quarter 2023 results and releases new encouraging data from CAR-T studies for presentation at ASH 2023

* First nine months 2023 key financials:
      * Group revenues of EUR448.9 million
      * Jyseleca® net sales of EUR82.1 million

* Cash and current financial investments of EUR3.8 billion at 30 September 2023
* Full year 2023 net Jyseleca® sales guidance of EUR100-EUR120 million and
        cash burn guidance of EUR380-EUR420 million reiterated
  * Jyseleca® strategic evaluation completed: signed Letter of Intent to
    transfer the Jyseleca® (filgotinib) business to Alfasigma, including the
    European and UK Marketing Authorizations and development activities, and
    approximately 400 positions in 14 European countries
  * Oncology pipeline:
      * New encouraging data from ongoing CAR-T Phase 1/2 studies in

relapsed/refractory chronic lymphocytic leukemia (rrCLL) and non-Hodgkin
        lymphoma (rrNHL) will be presented at ASH:
          * GLPG5201 in rrCLL: On the higher dose level, 6 of 6 patients
            responded to treatment (Objective Response Rate, ORR, of 100%) and
            5 of 6 patients achieved a Complete Response (CRR of 83%). Overall,
            11 of 12 patients responded to treatment (ORR of 92%) and 9 of 12
            patients achieved a CRR (75%). 5 of 7 patients with Richter's
            transformation (RT) achieved a CRR (71%). GLPG5201 shows an

acceptable safety profile with no cytokine release syndrome (CRS) >=
            Grade 3 or any immune effector cell-associated neurotoxicity
            syndrome (ICANS) observed.
          * GLPG5101 in rrNHL: On the higher dose level, 5 of 6 patients
            achieved a CRR (83%). Overall, 11 of 13 patients responded to
            treatment (ORR of 85%) and 9 of 13 patients achieved a CRR (69%).
            GLPG5101 showed an acceptable safety profile with no CRS > Grade 3
            or ICANS  >= Grade 2 observed.
      * Manufacturing agreement with U.S.-based Landmark Bio marks important

milestone in expanding CAR-T point-of-care network for the decentralized
        production in the Boston area
  * Immunology pipeline:
      * Advanced novel, oral, selective tyrosine kinase inhibitor, GLPG3667, in
        patients with systemic lupus erythematosus
      * Further progress made in initiating Phase 1b study with CD19 CAR-T
        candidate, GLPG5101, in patients with refractory systemic lupus
        erythematosus
  * Appointed Mr. Simon Sturge as Non-Executive Independent Director to the
    Board of Directors

Webcast presentation (https://edge.media- server.com/mmc/p/35gapkbb)tomorrow, 3 November 2023, at 13:00 CET / 8:00 am ET, www.glpg.com (http://www.glpg.com)
Mechelen, Belgium; 2 November 2023, 21:01 CET; regulated information - Galapagos
NV (Euronext & NASDAQ: GLPG) today announced its financial results for the first
nine months of 2023, a year-to-date business update and its outlook for the remainder of 2023.
"We continue to be very encouraged by the safety and efficacy results observed in the ongoing Phase 1/2 studies with our CD19 CAR-T programs, GLPG5201 and GLPG5101, with additional data to be presented at the upcoming ASH conference in
December. The new data released today indicate that both CAR-T candidates have the potential to improve survival for patients with a broad range of B-cell malignancies such as rrCLL and rrNHL. Moreover, the data show that our platform for the decentralized production of fresh CAR-T products, close to patients, has
the potential to reduce the median vein-to-vein time to only seven days. We look
forward to further building our data package following the agreement with Boston-based Landmark Bio, which is a key milestone in the geographical expansion of this unique point-of-care model and the start of clinical development of our CAR-T programs in the U.S.," said Dr. Paul Stoffels(1), CEO and Chairman of Galapagos.
"We made good progress with our small molecules clinical pipeline in immunology and dosed the first patient in the Phase 2 study with our novel, oral, selective
tyrosine kinase inhibitor, GLPG3667, in systemic lupus erythematosus. We also continue to prepare for the initiation of our Phase 1b study with CD 19 CAR-T candidate, GLPG5101, in patients with refractory systemic lupus erythematosus," concluded Dr. Paul Stoffels, CEO and Chairman of Galapagos.
"We  ended the  third quarter  with a  solid cash  position of  EUR3.8 billion and
reiterate  our cash burn  guidance of EUR380-EUR420  million," said Thad Huston, CFO

and COO of Galapagos. "Earlier this week, we announced that we completed the strategic evaluation exercise for Jyseleca® and that we signed a letter of intent with Alfasigma for the transfer of the Jyseleca® business. This planned transaction is a major step in our transformation, allowing us to right-size our
organization and focus our resources on building an R&D pipeline of transformational medicines, addressing high unmet patient needs."
Third quarter 2023 performance and recent business update
Oncology portfolio
  * GLPG5201 (CD19 CAR-T) in relapsed/refractory chronic lymphocytic leukemia
    (CLL), with or without Richter's transformation (RT)

* The Phase 1 dose-finding part of the EUPLAGIA-1-study has been completed
        and preparations to start the Phase 2 dose expansion are ongoing.
      * New preliminary data (data cut-off: 26 April 2023), for 12 patients
        enrolled in EUPLAGIA-1, will be presented at ASH (see ASH abstract and
        poster presentation details below). All 12 patients were diagnosed with
        rrCLL, 7 of 12 with RT. The results included in the abstract are
        summarized below:
          * GLPG5201 showed an acceptable safety profile with most treatment
            emergent adverse events (TEAEs) of Grade 1 or 2. CRS Grade 1 or 2
            was observed in 50% of the patients, and no CRS Grade >= 3 or any
            ICANS were observed. No deaths were reported.
          * 11 of 12 patients responded to treatment (Objective Response Rate,
            ORR of 92%). 9 of 12 patients achieved a Complete Response (CRR of
            75%). 5 of 7 patients with RT achieved a CRR (71%). On the higher

dose level, 6 of 6 patients responded to treatment (ORR of 100%) and
            5 of 6 patients achieved a CRR (83%).
          * Strong and consistent in vivo CAR-T expansion levels and a product
            consisting of early phenotype T cells were observed in all doses
            tested.
          * The data show that our point-of-care platform has the potential to
            deliver fresh product in a median vein-to-vein time of 7 days.
  * GLPG5101 (CD19 CAR-T) in relapsed/refractory non-Hodgkin lymphoma (rrNHL)
      * We are in the final stages of the Phase 1 dose-finding part of the

ongoing Phase 1/2 ATALANTA-1 study, which enrolled patients with diffuse large B cell lymphoma (DLBCL), mantle cell lymphoma and indolent
lymphoma. The Phase 2 expansion cohorts for indolent lymphoma and mantle
        cell lymphoma are open and the first 10 patients have been dosed.
        Recruitment is ongoing.

* New preliminary data (data cut-off: 2 May 2023) for 14 patients enrolled
        in ATALANTA-1 will be presented at ASH (see ASH abstract and poster
        presentation details below). 7 patients had diffuse large B-cell
        lymphoma, 3 had follicular lymphoma, 3 had mantle cell lymphoma and 1
        had marginal zone lymphoma. The results included in the abstract are
        summarized below:
          * GLPG5101 showed an acceptable safety profile with most TEAEs of

Grade 1 or 2. No CRS Grade > 3 and no ICANS Grade >= 2 were observed.
            In two patients, Grade 3-4 infections were observed, and three
            patients experienced Grade 4 neutropenia.
          * One Grade 5 intra-abdominal hemorrhage occurred 12 days post
            infusion caused by Grade 4 disseminated intravascular coagulation.
            This event occurred in an elderly patient with very rapidly
            progressive, primary refractory, double hit DLBCL, severe
            comorbidities, including a medical history of pulmonary embolism
            pre-CAR-T treatment, complicated by a Grade 3 CRS and respiratory
            insufficiency. One patient developed Grade 5 sepsis at six months
            post infusion while the patient was in ongoing CR.
          * 11 out of 13 evaluable patients responded to treatment (ORR of 85%)
            and 9 of 13 evaluable patients achieved a Complete Response (CRR of
            69%). 5 of 6 patients treated with the higher dose achieved a CRR
            (83%). 7 of 13 patients reported an ongoing response at time of
            analysis, with a duration of up to 12 months (median follow-up of
            4.5 months).
          * Strong and consistent in vivo CAR-T expansion levels and a product
            consisting of early phenotype T cells were observed in all doses
            tested.
          * The data show that our point-of-care platform has the potential to
            deliver fresh product in a median vein-to-vein time of 7 days.
  * Building a global CAR-T point-of-care network
      * We signed an agreement with Boston-based Landmark Bio and started the
        technology transfer for the decentralized production of our CAR-T cell
        therapy candidates, a key milestone to expand our CAR-T programs beyond
        Europe and start clinical development in the U.S.

Immunology portfolio
  * Jyseleca® (filgotinib) (JAK1)
      * Jyseleca® is reimbursed for rheumatoid arthritis (RA) and ulcerative
        colitis (UC) in 22 and 20 countries respectively. Sobi(2), our
        distribution and commercialization partner in Eastern and Central
        Europe, Portugal, Greece, and the Baltic countries, launched Jyseleca®
        in Slovenia in both RA and UC, and in Poland in RA.
  * Pipeline programs
      * We dosed the first patients in the Phase 2 GALACELA study of our novel,
        oral, selective tyrosine kinase 2 (TYK2) inhibitor, GLPG3667, in
        patients with systemic lupus erythematosus (SLE). Recruitment in the
        Phase 2 study in dermatomyositis is also ongoing.
      * We are preparing to open the first clinical centers to begin screening
        of patients with refractory SLE (rSLE) in the Phase 1b GALALUCA study
        with our CD19 CAR-T candidate, GLPG5101.

Corporate update
  * The Board of Directors appointed Mr. Simon Sturge as Non-Executive
    Independent Director by way of co-optation on 19 September 2023, replacing
    Dr. Mary Kerr who stepped down on 18 September 2023.

* On 30 October 2023, Galapagos announced that it signed a letter of intent to
    transfer the Jyseleca® business to Alfasigma, including the European and UK
    Marketing Authorizations and development activities, and approximately 400

positions in 14 European countries. Galapagos also announced that it intends
    to streamline its remaining operations and further build efficiencies, with
    an envisaged reduction of approximately 100 positions across the

organization. Completion of the intended transaction is subject to customary conditions, including consultations with works councils.
Financial highlights for the first nine months of 2023 (unaudited)
(EUR millions, except basic & diluted income/loss (-) per share)
+----------------------------+------+ |Nine months ended 30 | | |September | | +-----------+----------------+Change| |2023 |2022 | | +------------------------------------------+-----------+----------------+------+
|Product net sales |82.1 |60.5 |+36% | +------------------------------------------+-----------+----------------+------+
|Collaboration revenues |366.8 |349.7 |+5% | +------------------------------------------+-----------+----------------+------+
|Total net revenues |448.9 |410.2 |+9% | +------------------------------------------+-----------+----------------+------+
|Cost of sales |(13.6) |(7.9) |+71% | +------------------------------------------+-----------+----------------+------+
|R&D expenditure |(312.2) |(364.1) |-14% | +------------------------------------------+-----------+----------------+------+
|G&A(ii) and S&M(i)(ii) expenses |(182.2) |(202.7) |-10% | +------------------------------------------+-----------+----------------+------+
|Other operating income |40.1 |29.5 |+36% | +------------------------------------------+-----------+----------------+------+
|Operating loss |(19.0) |(135.1) | | +------------------------------------------+-----------+----------------+------+
|Fair value adjustments and net currency| | | | |exchange differences |36.2 |130.9 | | +------------------------------------------+-----------+----------------+------+
|Net other financial result |50.4 |(3.4) | | +------------------------------------------+-----------+----------------+------+
|Income taxes |(13.5) |(3.2) | | +------------------------------------------+-----------+----------------+------+
|Net profit/loss (-) of the period |54.1 |(10.8) | | +------------------------------------------+-----------+----------------+------+
|Basic and diluted income/loss (-) per| | | | |share (EUR) |0.82 |(0.16) | |
+------------------------------------------+-----------+----------------+------+
|Current financial investments and cash and| | | | |cash equivalents |3,811.7 (*)|4,362.1(**) | | +------------------------------------------+-----------+----------------+------+
(*) Starting from Q3 2023, our current financial investments and cash and cash equivalents include accrued interests (for a total of 21.7 million on 30
September 2023).
(**) Excluding EUR4.7 million of net accrued interest income.
Details of the financial results of the first nine months of 2023
Total  net  revenues  for  the  nine  months  ended 30 September 2023 was EUR448.9
million,  compared  to  EUR410.2  million  for  the nine months ended 30 September

2022, and consisted of:
  * Product net salesof Jyseleca®in Europe for the first nine months of 2023
    amounting to EUR82.1 million (EUR60.5 million in the first nine months of 2022).
      * Collaboration revenuesof EUR366.8 million for the first nine months of
        2023, compared to EUR349.7 million for the first nine months of 2022.

Collaboration revenues increased mainly due to revenue recognition related to the collaboration agreement with Gilead for the filgotinib development amounting
to EUR186.0 million in the first nine months of 2023 compared to EUR166.8 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 the Phase 3 DIVERSITY trial with filgotinib in CD and our decision not to submit a Marketing Authorization Application in Europe.
Our deferred income balance on 30 September 2023 includes EUR1.4 billion allocated
to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration, and EUR0.3 billion allocated to the
filgotinib development that is recognized over time until the end of the development period.
Total  operating  loss  for  the  nine  months ended 30 September 2023 was EUR19.0
million,  compared to total operating loss of  EUR135.1 million for the first nine

months ended 30 September 2022.
* Cost of sales related to Jyseleca® net sales in the first nine months of
2023 amounted to EUR13.6 million (EUR7.9 million in the first nine months of
    2022).
  * R&D expenditure in the first nine months of 2023 amounted to EUR312.2 million,

compared to EUR364.1 million for the first nine months of 2022. This decrease was primarily explained by lower personnel costs due to lower bonuses and
cost of subscription right plans, lower external outsourcing costs and lower depreciation costs. This decrease in depreciation costs was primarily due to an impairment recorded in the first nine months of 2022 of EUR26.7 million of
    previously capitalized upfront fees related to our collaboration with
    Molecure on the dual chitinase inhibitor OATD-01 (GLPG4716).

* S&M and G&A expenses amounted to EUR182.2 million in the first nine months of
    2023, compared to EUR202.7 million in the first nine months of 2022. This
    decrease was primarily due to a decrease in personnel costs and agency
    deliverables.
  * Other operating income amounted to EUR40.1 million in the first nine months of
    2023, compared to EUR29.5 million for the same period last year, mainly due to
    higher grant income.

Net financial income in the first nine months of 2023 amounted to EUR86.6 million,
compared to net financial income of EUR127.5 million for the first nine months of
2022.
  * Fair value adjustments and net currency exchange gains in the first nine
    months of 2023 amounted to EUR36.2 million, compared to fair value adjustments

and net currency exchange gains of EUR130.9 million for the first nine months
    of 2022, and were primarily attributable to EUR33.7 million of positive
    changes in fair value of current financial investments (compared to 26.0

million for the first nine months of 2022), and EUR3.5 million of unrealized currency exchange gains on our cash and cash equivalents and current
financial investments at amortized cost in U.S. dollars (compared to EUR102.1
    million for the first nine months of 2022).
  * Net other financial income in the first nine months of 2023 amounted to
    EUR50.4 million, compared to net other financial expenses of EUR3.4 million for
    the first nine months of 2022, and was primarily attributable to EUR54.6
    million of interest income, which increased significantly due to the
    increase in interest rates.
We  reported  a  group  net  profit  for  the first nine months of 2023 of EUR54.1

million, compared to a group net loss of EUR10.8 million for the first nine months
of 2022.
Cash position
Current  financial investments  and cash  and cash  equivalents totaled EUR3,811.7
million  on 30 September  2023, as compared  to EUR4,094.1  million on 31 December

2022 (excluding EUR9.9 million of net accrued interest income).
Total net decrease in cash and cash equivalents and current financial investments amounted to EUR282.4 million during the first nine months of 2023,
compared  to a net  decrease of EUR341.1  million during the  first nine months of
2022. This  net decrease was composed of  (i) EUR343.8 million of operational cash
burn,  offset by (ii) EUR3.5 million  of positive exchange rate differences, (iii)
EUR1.8  million  of  cash  proceeds  from  capital and share premium increase from
exercise  of subscription  rights in  the first  nine months of 2023, (iv) EUR24.5

million positive changes in fair value of current financial investments and (v) EUR20.2 million of accrued interest income on term deposits and EUR11.4 million
accrued interest income on treasury bills.
Outlook 2023
Financial outlook
  * We reiterate our full year 2023 net sales guidance for Jyseleca® of EUR100-
    EUR120 million and full year 2023 cash burn guidance in the range of EUR380-EUR420
    million.

R&D outlook
  * Oncology pipeline
      * We expect to include the first patient in the PAPILIO-1 Phase 1/2 study
        evaluating the feasibility, safety, and efficacy of our point-of-care
        manufactured BCMA CAR-T candidate, GLPG5301, in relapsed/refractory

multiple myeloma (rrMM) in the coming weeks. The study will be conducted
        in centers across Europe.
      * Three abstracts on our CAR-T portfolio in hemato-oncology have been
        selected for poster presentations at the 65(th) Society of Hematology
        (ASH) Annual Meeting and exposition conference taking place on 9-12
        December in San Diego, California (see details below). The two

presentations on EUPLAGIA-1 and ATALANTA-1 will include more recent data
        updates and additional data not found in the ASH abstracts. One
        presentation will outline the clinical study design of the PAPILIO-1
        Phase 1/2 study.
      * Following the point-of-care manufacturing agreement with Boston-based
        Landmark Bio, we expect to submit an Investigational New Drug

Application in the U.S. to start clinical development with our CD19 CAR-
        T programs in the first half of 2024.
  * Immunology portfolio
      * Pending approval of the Clinical Trial Application submitted in the
        European Union for our CD19 CAR-T candidate, GLPG5101, in patients with
        rSLE, we expect to open the first clinical centers and begin screening
        patients with rSLE in early 2024.

Business development
  * We will continue to extensively evaluate various product candidates and
    business development opportunities to further leverage our internal
    capabilities and accelerate and expand our product portfolio.

Conference call and webcast presentation
We will host a conference call and webcast presentation tomorrow 3 November 2023, at 13:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link (https://register.vevent.com/register/BI228dfcf821024ad9a2f8503d7e55d676), 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 (http://www.glpg.com) or via the following link (https://edge.media-server.com/mmc/p/35gapkbb). The archived webcast will be available for replay shortly after the close of the call on the investor section of the website (https://www.glpg.com/webcasts).
ASH presentation details
+-----------------------------+---------------------+--------------------------+
|Abstract Title |Authors |Presentation details | +-----------------------------+---------------------+--------------------------+
|Seven-day Vein-to-Vein Point-|Natalia Tovar, |Abstract | |of-Care Manufactured CD19 CAR|Valentin Ortiz- |(https://ash.confex.com/as| |T Cells (GLPG5201) in |Maldonado, Nuria |h/2023/webprogram/Paper189| |Relapsed/Refractory CLL/SLL |Martinez-Cibrian, |321.html) | |including Richter's |Sergi Betriu, Daniel |Poster Number: 2112 | |Transformation: Results from |Esteban, Ana |Date: 9 Dec | |the Phase 1 Euplagia-1 Trial |Triguero, Nadia |2023, 5:30-7:30 pm | | |Verbruggen, Anna D.D.|Session: Cellular | | |van Muyden, Maike |Immunotherapies: Early | | |Spoon, Margot J. Pont|Phase and Investigational | | | |Therapies: Poster I | +-----------------------------+---------------------+--------------------------+
|Seven-day Vein-to-Vein Point-|Marie José Kersten, |Abstract | |of-Care Manufactured CD19 CAR|Kirsten Saevels, |(https://ash.confex.com/as| |T Cells (GLPG5101) in |Sophie Servais, Yves |h/2023/webprogram/Paper172| |Relapsed/Refractory NHL: |Beguin, Joost |736.html) | |Results from the Phase 1 |Vermaat,Nadia |Poster Number: 2113 |
|Atalanta-1 Trial |Verbruggen, Anna DD |Date: 9 Dec | | |Van Muyden, Margot J |2023, 5:30-7:30 pm | | |Pont, Maria T |Session: Cellular | | |Kuipers, Sébastien |Immunotherapies: Early | | |Anguille |Phase and Investigational | | | |Therapies: Poster I | +-----------------------------+---------------------+--------------------------+
|Rationale for and Design of |Niels van der Donk, |Abstract | |Papilio-1: a Phase 1/2, |Sebastien Anguille, |(https://ash.confex.com/as| |Multicenter, Open-Label Study|Jo Caers, Marte C. |h/2023/webprogram/Paper189| |to Evaluate the Feasibility, |Liefaard, Christian |001.html) | |Safety, and Efficacy of |Jacques, Anna D.D. |Poster Number: 4859 | |Point-of-Care-Manufactured |van Muyden |Date: 11 Dec | |Anti-B-Cell Maturation | |2023, 6:00-8:00 pm | |Antigen Chimeric Antigen | |Session: Cellular | |Receptor T Cells (GLPG5301) | |Immunotherapies: Early | |in Relapsed/Refractory | |Phase and Investigational | |Multiple Myeloma | |Therapies: Poster III | | | | | +-----------------------------+---------------------+--------------------------+
Financial calendar 2024
                                                    (webcast 23 February 2024)
  22 February 2024   Full year 2023 results
  28 March 2024      Annual report 2023
  30 April 2024      Annual Shareholders' Meeting
  2 May 2024         First quarter 2024 results     (webcast 3 May 2024)
  1 August 2024      Half-year 2024 results         (webcast 2 August 2024)
  30 October 2024    Third quarter 2024 results     (webcast 31 October 2024)

About Galapagos
We are a global biotechnology company with operations in Europe and the US dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize the most compelling science, technology, and collaborative approaches to create a deep pipeline of best-in-class small molecules, CAR-T therapies, and biologics in oncology and immunology. With capabilities from lab to patient, including a decentralized, point-of-care CAR-T manufacturing network, we are committed to challenging the status quo and delivering results for our patients, employees and shareholders. For additional information, please visit www.glpg.com (http://www.glpg.com/) or follow us on LinkedIn (https://www.linkedin.com/company/glpg/) or X (formerly Twitter (https://twitter.com/GalapagosGlobal)).
Jyseleca® is a trademark of Galapagos NV and Gilead Sciences, Inc. or its related companies. Except for filgotinib's approval as Jyseleca® for the treatment of moderate to severe active RA and UC by the relevant regulatory authorities in the European Union, Great Britain, and Japan, our drug candidates
are investigational; their efficacy and safety have not been fully evaluated by any regulatory authority.
Contact
  Media inquiries:                          Investor inquiries:
  Marieke Vermeersch                        Sofie Van Gijsel
  +32 479 490 603                           +1 781 296 1143
  media@glpg.com  (mailto:media@glpg.com)   ir@glpg.com (mailto:ir@glpg.com)
                                            Sandra Cauwenberghs
                                            ir@glpg.com (mailto: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," "on track," "expect, " "encouraging," "expand," "advance," "plan," "estimate," "will," "continue," "aim," "intend," "future," "guidance," "outlook,", "indicate", "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 "Third quarter 2023 performance and recent business update" and "Outlook 2023", the guidance from management regarding our expected operational use of cash and estimated peak sales for Jyseleca® during the financial year 2023, statements related to the contemplated transaction between Galapagos and Alfasigma and the planned reduction in force, statements regarding our strategic
and capital allocation priorities, 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 our regulatory and R&D outlook, statements regarding the expected timing, design and
readouts of ongoing and planned clinical trials, including but not limited to (i) filgotinib in juvenile arthritis, (ii) GLPG5101 in rrNHL and rSLE, (iii) GLPG5201 in rrCLL, and (iv) GLPG5301 in rrMM, statements regarding our commercialization efforts for filgotinib, our product candidates, and any of our
future approved products, if any, statements regarding our expectations on commercial sales of filgotinib and any of our product candidates (if approved), statements related to the timing for submission of an Investigational New Drug application and the clinical development of our CAR-T program in the United States, and statements related to our portfolio goals and business plans. 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 estimates 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, rrSLL, 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, 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, TORTUGA, PAPILIO-1, GALALUCA 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 partners Gilead 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 CAR-T 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 encounter challenges retaining or attracting talent, risks related to potential disruptions in our operations, 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. 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 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:
  * the net proceeds, if any, from share capital and share premium increases
    included in the net cash flows generated from/used in (-) financing
    activities
  * the net proceeds or cash used, if any, in acquisitions or disposals of
    businesses; the movement in restricted cash and movement in current
    financial investments, if any, the cash advances and loans given to third
    parties, if any, included in the net cash flows generated from/used in (-)
    investing activities
  * the cash used for other liabilities related to the acquisition of

businesses, if any, included in the net cash flows generated from/used in (- ) operating activities.
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 nine
months ended 30 September 2023 amounted to EUR343.8 million and can be reconciled
to our cash flow statement by considering the decrease in cash and cash equivalents of EUR348.1 million, adjusted by (i) the cash proceeds from capital
and share premium increase from the exercise of subscription rights by employees
for EUR1.8 million, and (ii) the net purchase of current financial investments
amounting to EUR6.1 million.
(ii) General and administrative
(iii) Sales and marketing
Addendum
Consolidated statements of income and comprehensive income/loss (-) (unaudited)
Consolidated income statement
+-------------------+ | Nine months ended | | 30 September | +---------+---------+ (thousands of EUR, except per share data) | 2023 | 2022 |
+----------------------------------------------------------+---------+---------+
|Product net sales | 82,075 | 60,491 | +----------------------------------------------------------+---------+---------+
|Collaboration revenues | 366,773 | 349,669 | +----------------------------------------------------------+---------+---------+
|Total net revenues | 448,848 | 410,160 | +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Cost of sales |(13,540) | (7,938) | +----------------------------------------------------------+---------+---------+
|Research and development expenditure |(312,180)|(364,067)| +----------------------------------------------------------+---------+---------+
|Sales and marketing expenses |(88,147) |(105,313)| +----------------------------------------------------------+---------+---------+
|General and administrative expenses |(94,022) |(97,373) | +----------------------------------------------------------+---------+---------+
|Other operating income | 40,086 | 29,474 | +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Operating loss |(18,954) |(135,056)| +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Fair value adjustments and net currency exchange| | | |differences | 36,247 | 130,900 | +----------------------------------------------------------+---------+---------+
|Other financial income | 55,122 | 9,675 | +----------------------------------------------------------+---------+---------+
|Other financial expenses | (4,767) |(13,074) | +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Profit/loss (-) before tax | 67,648 | (7,555) | +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Income taxes |(13,510) | (3,229) | +----------------------------------------------------------+---------+---------+
| | | | +----------------------------------------------------------+---------+---------+
|Net profit/loss (-) | 54,138 |(10,784) | +----------------------------------------------------------+---------+---------+
|Net profit/loss (-) attributable to: | | | +----------------------------------------------------------+---------+---------+
|Owners of the parent | 54,138 |(10,784) | +----------------------------------------------------------+---------+---------+
|Basic and diluted income/loss (-) per share | 0.82 | (0.16) | +----------------------------------------------------------+---------+---------+
Consolidated statement of comprehensive income/loss (-)
+---------------+ | Nine months | | ended | | 30 September | +------+--------+ (thousands of EUR) | 2023 | 2022 |
+--------------------------------------------------------------+------+--------+
|Net profit/loss (-) |54,138|(10,784)| +--------------------------------------------------------------+------+--------+
|Items that may be reclassified subsequently to profit or loss:| | | +--------------------------------------------------------------+------+--------+
|Translation differences, arisen from translating foreign| | | |activities | 318 | (7) | +--------------------------------------------------------------+------+--------+
|Other comprehensive income/loss (-), net of income tax | 318 | (7) | +--------------------------------------------------------------+------+--------+
| | | | +--------------------------------------------------------------+------+--------+
|Total comprehensive income/loss (-) attributable to: | | | +--------------------------------------------------------------+------+--------+
|Owners of the parent |54,456|(10,791)| +--------------------------------------------------------------+------+--------+
Consolidated statements of financial position (unaudited)
                                         +--------------+-------------+
                                         | 30 September | 31 December |
                                         +--------------+-------------+
  (thousands of EUR)                       |     2023     |    2022     |

+----------------------------------------+--------------+-------------+
| Assets | | |
+----------------------------------------+--------------+-------------+
| Goodwill | 69,863 | 69,813 |
+----------------------------------------+--------------+-------------+
| Intangible assets other than goodwill | 132,313 | 146,354 |
+----------------------------------------+--------------+-------------+
| Property, plant and equipment | 136,803 | 154,252 |
+----------------------------------------+--------------+-------------+
| Deferred tax assets | 1,232 | 1,363 |
+----------------------------------------+--------------+-------------+
| Non-current R&D incentives receivables | 138,121 | 119,941 |
+----------------------------------------+--------------+-------------+
| Other non-current assets | 16,911 | 5,778 |
+----------------------------------------+--------------+-------------+
| Non-current assets | 495,244 | 497,501 |
+----------------------------------------+--------------+-------------+
| Inventories | 55,605 | 52,925 |
+----------------------------------------+--------------+-------------+
| Trade and other receivables | 46,918 | 40,429 |
+----------------------------------------+--------------+-------------+
| Current R&D incentives receivables | 26,126 | 26,126 |
+----------------------------------------+--------------+-------------+
| Current financial investments | 3,652,333 | 3,585,945 |
+----------------------------------------+--------------+-------------+
| Cash and cash equivalents | 159,375 | 508,117 |
+----------------------------------------+--------------+-------------+
| Other current assets | 15,735 | 23,307 |
+----------------------------------------+--------------+-------------+
| Current assets | 3,956,092 | 4,236,850 |
+----------------------------------------+--------------+-------------+
| Total assets | 4,451,336 | 4,734,351 |
+----------------------------------------+--------------+-------------+
| | | |
+----------------------------------------+--------------+-------------+
| Equity and liabilities | | |
+----------------------------------------+--------------+-------------+
| Share capital | 293,937 | 293,604 |
+----------------------------------------+--------------+-------------+
| Share premium account | 2,736,993 | 2,735,557 |
+----------------------------------------+--------------+-------------+
| Other reserves | (4,932) | (4,853) |
+----------------------------------------+--------------+-------------+
| Translation differences | (1,196) | (1,593) |
+----------------------------------------+--------------+-------------+
| Accumulated losses | (403,242) | (496,689) |
+----------------------------------------+--------------+-------------+
| Total equity | 2,621,560 | 2,526,026 |
+----------------------------------------+--------------+-------------+
| Retirement benefit liabilities | 2,408 | 5,540 |
+----------------------------------------+--------------+-------------+
| Deferred tax liabilities | 25,325 | 20,148 |
+----------------------------------------+--------------+-------------+
| Non-current lease liabilities | 8,469 | 14,692 |
+----------------------------------------+--------------+-------------+
| Other non-current liabilities | 31,449 | 21,808 |
+----------------------------------------+--------------+-------------+
| Non-current deferred income | 1,318,090 | 1,623,599 |
+----------------------------------------+--------------+-------------+
| Non-current liabilities | 1,385,741 | 1,685,787 |
+----------------------------------------+--------------+-------------+
| Current lease liabilities | 5,678 | 7,209 |
+----------------------------------------+--------------+-------------+
| Trade and other liabilities | 121,129 | 148,675 |
+----------------------------------------+--------------+-------------+
| Current tax payable | 1,764 | 1,022 |
+----------------------------------------+--------------+-------------+
| Current deferred income | 315,465 | 365,631 |
+----------------------------------------+--------------+-------------+
| Current liabilities | 444,036 | 522,538 |
+----------------------------------------+--------------+-------------+
| Total liabilities | 1,829,776 | 2,208,325 |
+----------------------------------------+--------------+-------------+
| Total equity and liabilities | 4,451,336 | 4,734,351 |
+----------------------------------------+--------------+-------------+
Consolidated cash flow statements (unaudited)
+-----------------------+| Nine months ended |
| 30 September | +-----------+-----------+ (thousands of EUR) | 2023 | 2022 |
+------------------------------------------------------+-----------+-----------+
|Net profit/loss (-) of the period | 54,138 | (10,784) | +------------------------------------------------------+-----------+-----------+
|Adjustment for non-cash transactions | 44,344 | (25,707) | +------------------------------------------------------+-----------+-----------+
|Adjustment for items to disclose separately under| | | |operating cash flow | (40,165) | 1,599 | +------------------------------------------------------+-----------+-----------+
|Adjustment for items to disclose under investing and| | (1,700) | |financing cash flows | (11,809) | | +------------------------------------------------------+-----------+-----------+
|Change in working capital other than deferred income | (50,329) | 57,472 | +------------------------------------------------------+-----------+-----------+
|Cash used for other liabilities related to the| | | |acquisition of subsidiaries | - | (11,080) | +------------------------------------------------------+-----------+-----------+
|Decrease in deferred income | (359,259) | (318,167) | +------------------------------------------------------+-----------+-----------+
|Cash used in operations | (363,081) | (308,367) | +------------------------------------------------------+-----------+-----------+
|Interest paid | (3,729) | (10,940) | +------------------------------------------------------+-----------+-----------+
|Interest received | 35,063 | 2,262 | +------------------------------------------------------+-----------+-----------+
|Corporate taxes paid | (7,357) | (3,637) | +------------------------------------------------------+-----------+-----------+
|Net cash flows used in operating activities | (339,104) | (320,682) | +------------------------------------------------------+-----------+-----------+
|Purchase of property, plant and equipment | (11,073) | (19,808) | +------------------------------------------------------+-----------+-----------+
|Purchase of and expenditure in intangible fixed assets| (222) | (9,308) | +------------------------------------------------------+-----------+-----------+
|Proceeds from disposal of property, plant and| | | |equipment | 2,304 | 719 | +------------------------------------------------------+-----------+-----------+
|Purchase of current financial investments |(2,615,112)|(2,505,688)| +------------------------------------------------------+-----------+-----------+
|Investment income received related to current| | | |financial investments | 9,857 | 1,181 | +------------------------------------------------------+-----------+-----------+
|Sale of current financial investments | 2,609,023 | 1,394,549 | +------------------------------------------------------+-----------+-----------+
|Cash out from acquisition of subsidiaries, net of cash| | | |acquired | - | (115,270) | +------------------------------------------------------+-----------+-----------+
|Cash advances and loans to third parties | - | (10,000) | +------------------------------------------------------+-----------+-----------+
|Net cash flows used in investing activities | (5,222) |(1,263,625)| +------------------------------------------------------+-----------+-----------+
|Payment of lease liabilities | (5,580) | (6,263) | +------------------------------------------------------+-----------+-----------+
|Proceeds from capital and share premium increases from| | | |exercise of subscription rights | 1,770 | 6,695 | +------------------------------------------------------+-----------+-----------+
|Net cash flows generated from/used in (-) financing| | | |activities | (3,810) | 432 | +------------------------------------------------------+-----------+-----------+
| | | | +------------------------------------------------------+-----------+-----------+
|Decrease in cash and cash equivalents | (348,136) |(1,583,875)| +------------------------------------------------------+-----------+-----------+
| | | | +------------------------------------------------------+-----------+-----------+
|Cash and cash equivalents at beginning of year | 508,117 | 2,233,368 | +------------------------------------------------------+-----------+-----------+
|Decrease in cash and cash equivalents | (348,136) |(1,583,875)| +------------------------------------------------------+-----------+-----------+
|Effect of exchange rate differences on cash and cash| | | |equivalents | (607) | 26,026 | +------------------------------------------------------+-----------+-----------+
|Cash and cash equivalents at end of the period | 159,375 | 675,519 | +------------------------------------------------------+-----------+-----------+
+-------------------+ | 30 September | +---------+---------+ (thousands of EUR) | 2023 | 2022 |
+----------------------------------------------------------+---------+---------+
|Current financial investments |3,652,333|3,686,557| +----------------------------------------------------------+---------+---------+
|Cash and cash equivalents | 159,375 | 675,519 | +----------------------------------------------------------+---------+---------+
|Current financial investments and cash and cash| | | |equivalents |3,811,708|4,362,076| +----------------------------------------------------------+---------+---------+
Consolidated statements of changes in equity (unaudited)
+-------+---------+-----------+--------+-----------+---------+ | | Share | | | | | | Share | premium |Translation| Other |Accumulated| | (thousands of EUR) |capital| account |differences|reserves| losses | Total |
+-----------------+-------+---------+-----------+--------+-----------+---------+
|On 1 January 2022|292,075|2,730,391| (1,722) |(10,177)| (367,205) |2,643,362| +-----------------+-------+---------+-----------+--------+-----------+---------+
|Net loss | | | | | (10,784) |(10,784) | +-----------------+-------+---------+-----------+--------+-----------+---------+
|Other | | | | | | | |comprehensive | | | | | | | |income/loss (-) | | | 676 | (683) | | (7) | +-----------------+-------+---------+-----------+--------+-----------+---------+
|Total | | | | | | | |comprehensive | | | | | | | |income/loss (-) | | | 676 | (683) | (10,784) |(10,791) | +-----------------+-------+---------+-----------+--------+-----------+---------+
|Share-based | | | | | | | |compensation | | | | | 51,085 | 51,085 | +-----------------+-------+---------+-----------+--------+-----------+---------+
|Exercise of| | | | | | | |subscription | | | | | | | |rights | 1,530 | 5,165 | | | | 6,695 | +-----------------+-------+---------+-----------+--------+-----------+---------+
|On 30 September| | | | | | | |2022 |293,604|2,735,557| (1,046) |(10,860)| (326,905) |2,690,351| +-----------------+-------+---------+-----------+--------+-----------+---------+
| | | | | | | | +-----------------+-------+---------+-----------+--------+-----------+---------+
|On 1 January 2023|293,604|2,735,557| (1,593) |(4,853) | (496,689) |2,526,026| +-----------------+-------+---------+-----------+--------+-----------+---------+
|Net profit | | | | | 54,138 | 54,138 | +-----------------+-------+---------+-----------+--------+-----------+---------+
|Other | |
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
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