Filgotinib Maleate

Advanced potentially best-in-class cell therapy and small molecule R&D pipeline comprising four clinical assets and >15 discovery programs in oncology and immunologyExecuted agreements with BridGene Biosciences and Thermo Fisher Scientific, and investment in Frontier MedicinesTransferred Jyseleca® business to Alfasigma S.p.A., freeing up resources to invest in growth areasGroup net revenues in the first quarter of €100 millionCash and current financial investments of €3.6 billion on 31 March 2024Reconfirmed 2024 cash burni guidance of €280 million to €320 million, not including potential business development opportunities Webcast presentation with management on 3 May 2024, at 14:00 CET / 8:00 am ET, www.glpg.com Mechelen, Belgium; 2 May 2024, 22:01 CET; regulated information – Galapagos NV (Euronext & NASDAQ: GLPG) today announced its first quarter 2024 financial results and provided a business update and outlook for the remainder of 2024. “We are moving forward with a renewed focus, a differentiated and expanding R&D pipeline, and competitive technology platforms to bring innovation to patients around the world. We continue to build a strong team of global leaders and we expanded our U.S. footprint,” said Dr. Paul Stoffels1, CEO and Chairman of the Board of Directors of Galapagos. “As we look forward to the year ahead, we strive to make important progress in our clinical programs, achieving regulatory milestones to initiate clinical development of our CAR-T programs in the U.S., and expanding our decentralized CAR-T network in the U.S. and Europe. In parallel, we will continue to build our early-stage pipeline of cell therapy and small molecule investigational medicines in oncology and immunology, both internally and through external partnerships.” Thad Huston, CFO and COO of Galapagos, concluded: “We are committed to investing in our internal R&D pipeline, while we continue to actively pursue business development opportunities. We are broadening our oncology and immunology portfolio and will capitalize on opportunities that are aligned with our strategic objectives.” First quarter 2024 and recent business update At the Annual and Extraordinary Shareholders’ Meetings held on 30 April 2024, all proposed resolutions were approved (see: press release of 30 April 2024). Presented our innovative decentralized CAR-T manufacturing and 7-day vein-to-vein approach to hematological cancer care at the EBMT-EHA and EBMT annual meetings with new preliminary translational and previously published encouraging clinical data of our CD19 CAR-T candidates. The data support the promise of GLPG5101 in relapsed/refractory non-Hodgkin lymphoma (NHL) and GLPG5201 in relapsed/refractory chronic lymphocytic leukemia (CLL) and Richter transformation (RT), in addressing the critical needs of patients facing poor prognosis. Discontinued the development of CD19 CAR-T candidate in refractory systemic lupus erythematosus. Transferred the Jyseleca® business to Alfasigma per 31 January 2024. Signed a strategic collaboration and license agreement with BridGene Biosciences to further strengthen our growing early-stage oncology precision medicine pipeline. Entered into a strategic collaboration agreement with Thermo Fisher Scientific for decentralized CAR-T manufacturing in the San Francisco area.Participated with an investment of $40.0 million in the Series C financing round of precision oncology pioneer Frontier Medicines. Financial performanceFirst quarter 2024 key figures (consolidated)(€ millions, except basic & diluted income per share) Three months ended 31 March % Change 2024 2023 Total net revenues 62.4 58.6 +7% Cost of sales (2.5) - R&D expenses (71.6) (52.5) +36% G&Aii and S&Miii expenses (30.8) (27.1) +14% Other operating income 9.4 6.8 +37% Operating loss (33.1) (14.2) Fair value adjustments and net exchange differences 30.6 (9.7) Net other financial result 25.4 12.5 Income taxes 0.6 0.2 Net profit/loss (-) from continuing operations 23.5 (11.2) Net profit from discontinued operations, net of tax 66.7 34.4 Net profit of the period 90.2 23.2 Basic and diluted earnings per share (€) 1.4 0.4 Current financial investments, cash & cash equivalents 3,557.9 4,005.5 (*) (*) Including €15.4 million of net accrued interest income DETAILS OF THE FINANCIAL RESULTS OF THE FIRST THREE MONTHS OF 2024As a consequence of the transfer of our Jyseleca® business to Alfasigma, the revenues and costs related to Jyseleca® for the first quarter of 2024 are presented separately from the results of our continuing operations in the line ‘Net profit from discontinued operations, net of tax’ in our consolidated income statement. The comparative first quarter of 2023 has been restated accordingly for the presentation of the results related to the Jyseleca® business. Results from our continuing operationsTotal operating loss from continuing operations for the three months ended 31 March 2024 was €33.1 million, compared to an operating loss of €14.2 million for the three months ended 31 March 2023. Total net revenues for the three months ended 31 March 2024 amounted to €62.4 million, compared to €58.6 million for the three months ended 31 March 2023. The revenue recognition related to the exclusive access rights granted to Gilead for our drug discovery platform amounted to €57.6 million for the first three months of both 2024 and 2023. Our deferred income balance at 31 March 2024 includes €1.2 billion allocated to our drug discovery platform that is recognized linearly over the remaining period of our 10-year collaboration. Cost of sales for the three months ended 31 March 2024 amounted to €2.5 million and related to the supply of Jyseleca® to Alfasigma under the transition agreement. The related revenues are booked in total net revenues.R&D expenses in the first three months of 2024 amounted to €71.6 million, compared to €52.5 million for the first three months of 2023. This increase was primarily explained by higher costs for CAR-T and small molecule programs in oncology.G&A and S&M expenses amounted to €30.8 million in the first three months of 2024, compared to €27.1 million in the first three months of 2023. This increase was primarily due to an increase in legal and professional fees, mainly related to business development activities. Other operating income amounted to €9.4 million in the first three months of 2024, compared to €6.8 million for the same period last year. This increase is mainly due to €2.2 million of recharges for transition services to Alfasigma for the months of February and March 2024. Net financial income in the first three months of 2024 amounted to €56.0 million, compared to net financial income of €2.8 million for the first three months of 2023. Fair value adjustments and net currency exchange gains in the first three months of 2024 amounted to €30.6 million, compared to fair value adjustments and net currency exchange losses of €9.7 million for the first three months of 2023, and were primarily attributable to €12.4 million of unrealized currency exchange gains on our cash and cash equivalents and current financial investments at amortized cost in U.S. dollars, and to €17.6 million of positive changes in fair value of current financial investments.Net other financial income in the first three months of 2024 amounted to €25.4 million, compared to net other financial income of €12.5 million for the first three months of 2023, and was primarily attributable to €25.2 million of interest income, which increased significantly due to the increase in interest rates. Net profit from continuing operations for the first three months of 2024 was €23.5 million, compared to a net loss from continuing operations of €11.2 million for the first three months of 2023.Results from discontinued operations (€ millions) Three months ended 31 March % Change 2024 2023 Product net sales 11.3 26.7 -58% Collaboration revenues 26.0 93.6 -72% Total net revenues 37.3 120.3 -69% Cost of sales (1.9) (3.6) -47% R&D expenses (13.4) (51.0) -74% G&A and S&M expenses (9.2) (31.1) -71% Other operating income 53.9 1.5 Operating profit 66.7 36.1 Net financial result 0.1 (1.3) Income taxes (0.1) (0.4) Net profit from discontinued operations 66.7 34.4 Total operating profit from discontinued operations amounted to €66.7 million in the first three months of 2024, compared to an operating profit of €36.1 million in the same period last year. Product net sales of Jyseleca® in Europe were €11.3 million for the first three months of 2024 consisting of sales to customers in January 2024. Product net sales to customers for the first three months of 2023 amounted to €26.7 million. As from 1 February 2024, all economics linked to the sales of Jyseleca® in Europe are to the benefit of Alfasigma.Collaboration revenues for the development of filgotinib with Gilead amounted to €26.0 million for the first three months of 2024, compared to €93.6 million for the same period last year. The sale of the Jyseleca® business to Alfasigma on 31 January 2024 led to the full recognition in revenue of the remaining deferred income related to filgotinib. Cost of sales related to Jyseleca® net sales were €1.9 million for the first three months of 2024. Cost of sales related to Jyseleca® net sales for the first three months of 2023 amounted to €3.6 million. R&D expenses for the development of filgotinib for the first three months of 2024 amounted to €13.4 million, compared to €51.0 million in the first three months of 2023. As from 1 February 2024, all filgotinib development expenses are recharged to Alfasigma.G&A and S&M expenses related to the Jyseleca® business amounted to €9.2 million in the first three months of 2024, compared to €31.1 million in the first three months of 2023. As from 1 February 2024, all remaining G&A and S&M expenses relating to Jyseleca® are recharged to Alfasigma.Other operating income for the first three months of 2024 amounted to €53.9 million (€1.5 million for the same period last year) and comprised €53.2 million related to the preliminary calculation of the gain on the sale of the Jyseleca® business to Alfasigma. This preliminary result at 31 March 2024 of the transaction is considering the following elements: €50.0 million of upfront payment received at closing of the transaction of which €40.0 million was paid on an escrow account. This amount will be kept in escrow for a period of one year after the closing date of 31 January 2024. We gave customary representations and warranties which are capped and limited in time (at 31 March 2024, this €40.0 million is presented as “Escrow account” in our balance sheet).€13.2 million of cash received at closing of the transaction from Alfasigma for preliminary settlement for net cash and working capital and an additional adjustment estimated at €1.1 million related to settlement for completion accounts.€47.0 million of estimated fair value on 31 January 2024 of the future earn-outs payable by Alfasigma to us (the fair value of these future earn-outs at 31 March 2024 is presented on the lines “Non-current contingent consideration receivable” and “Trade and other receivables”).€40.0 million of liability towards Alfasigma on 31 January 2024 for R&D cost contributions of which €5.0 million was paid in the first quarter of 2024 (at 31 March 2024, €35.0 million of liabilities for R&D cost contribution is presented in our balance sheet in “Other non-current liabilities” for €10.0 million and on the line “Trade and other liabilities” for €25.0 million). Net profit from discontinued operations related to Jyseleca® amounted to €66.7 million for the first three months of 2024, compared to a net profit amounting to €34.4 million for the first three months of 2023. Cash, cash equivalents and current financial investments totaled €3,557.9 million as of 31 March 2024, as compared to €3,684.5 million as of 31 December 2023. Total net decrease in cash and cash equivalents and current financial investments amounted to €126.6 million during the first three months of 2024, compared to a net decrease of €88.6 million during the first three months of 2023. This net decrease was composed of (i) €125.2 million of operational cash burn, (ii) €36.9 million for the acquisition of financial assets held at fair value through profit or loss, (iii) €38.7 million of net cash in related to the sale of the Jyseleca® business to Alfasigma of which €40.0 million has been transferred to an escrow account, offset by (iv) €36.8 million of positive exchange rate differences, positive changes in fair value of current financial investments and variation in accrued interest income. Outlook 2024 Financial outlook For the full year 2024, we reconfirm our cash burn guidance of €280 million to €320 million (compared to €414.8 million for the full year 2023), not including future potential business development opportunities. R&D Outlook We are progressing three CAR-T Phase 1/2 studies in hemato-oncology: GLPG5101 in relapsed/refractory NHL; GLPG5201 in relapsed/refractory CLL, and RT; andGLPG5301 in relapsed/refractory multiple myeloma. We are progressing two Phase 2 studies with TYK2 inhibitor GLPG3667, in systemic lupus erythematosus and in dermatomyositis. We plan to file Investigational New Drug applications in the U.S. to progress clinical development of our CAR-T programs in hemato-oncology. We will further upscale our CAR-T network and operations in the U.S. and Europe. Business development We will continue to evaluate business development opportunities that fit our strategy to accelerate and expand our pipeline of potential best-in-class investigational medicines in our therapeutic focus areas of oncology and immunology. Conference call and webcast presentationWe will host a conference call and webcast presentation on 3 May 2024, at 14:00 CET / 8:00 am ET. To participate in the conference call, please register in advance using this link. Dial-in numbers will be provided upon registration. The conference call can be accessed 10 minutes prior to the start of the call by using the conference access information provided in the email received 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 2024 1 August 202430 October 2024 Half-year 2024 resultsThird quarter 2024 results (webcast: 2 August 2024)(webcast: 31 October 2024) About GalapagosWe are a biotechnology company with operations in Europe and the U.S. dedicated to developing transformational medicines for more years of life and quality of life. Focusing on high unmet medical needs, we synergize 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 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 or follow us on LinkedIn or X (formerly Twitter). For further information, please contact: Media inquiries:Marieke Vermeersch +32 479 490 603 media@glpg.com Jennifer Wilson + 44 7539 359 676media@glpg.com Investor inquiries:Sofie Van Gijsel +1 781 296 1143ir@glpg.comSandra Cauwenberghs +32 495 58 46 63ir@glpg.com Forward-looking statementsThis press release contains 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 “believe,” “anticipate,” “expect,” ”intend,” “plan,” “seek,” “upcoming,” “future,” “estimate,” “may,” “will,” “could,” “would,” “potential,” “forward,” “goal,” “next,” “continue,” “should,” “encouraging,” “aim,” “progress,” “remain,” “explore,” “further,” as well as similar expressions. These statements include, but are not limited to, the guidance from management regarding our financial results (including guidance regarding the expected operational use of cash for the fiscal year 2024), statements regarding our regulatory outlook, statements regarding the amount and timing of potential future milestones, and other payments, statements regarding our R&D plans, strategy and outlook, including progress on our oncology or immunology 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) GLPG3667 in SLE and DM, (ii) GLPG5101 in rrNHL, (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 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, and statements related to our portfolio goals and business plans. Galapagos cautions the reader that forward-looking statements are based on our management’s current expectations and beliefs and are not guarantees of future performance. Forward-looking statements may involve known and unknown risks, uncertainties and other factors which might cause our actual results, financial condition and liquidity, performance or achievements, or the industry in which we operate, 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. In addition, even if Galapagos’ results, performance, financial condition and liquidity, and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. Such risks include, but are not limited to, the risk that our expectations and management’s guidance regarding our 2024 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 DM, SLE, relapsed/refractory NHL, rrCLL, rrMM and other immunologic and oncologic 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 risk that the preliminary and topline data from the ATALANTA-1, EUPLAGIA-1 and PAPILIO-1-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, Lonza, BridGene Biosciences and Thermo Fisher Scientific), the risk that the transfer of the Jyseleca® business 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. A further list and description 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 our subsequent 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 the result of our operations, financial condition and liquidity, or the industry in which we operate are consistent with such forward-looking statements, they may not be predictive of results, performance or achievements 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 to reflect any change in our expectations or any change in events, conditions or circumstances, unless specifically required by law or regulation. Addendum Consolidated statements of income and comprehensive income/loss (-) (unaudited) Consolidated income statement Three months ended31 March (thousands of €, except per share data) 2024 2023 Total net revenues 62,432 58,574 Cost of sales (2,548) - Research and development expenses (71,614) (52,559) Sales and marketing expenses (2,907) (1,017) General and administrative expenses (27,881) (26,034) Other operating income 9,387 6,838 Operating loss (33,131) (14,198) Fair value adjustments and net currency exchange differences 30,613 (9,697) Other financial income 25,707 13,358 Other financial expenses (254) (844) Profit/loss (-) before tax 22,935 (11,380) Income taxes 568 185 Net profit/loss (-) from continuing operations 23,503 (11,195) Net profit from discontinued operations, net of tax 66,717 34,402 Net profit 90,220 23,207 Net profit attributable to: Owners of the parent 90,220 23,207 Basic and diluted earnings per share 1.37 0.35 Basic and diluted earnings/loss (-) per share from continuing operations 0.36 (0.17) Consolidated statement of comprehensive income/loss (–) Three months ended31 March (thousands of €) 2024 2023 Net profit 90,220 23,207 Items that will not be reclassified subsequently to profit or loss: Re-measurement of defined benefit obligation 74 - Items that may be reclassified subsequently to profit or loss: Translation differences, arisen from translating foreign activities 79 (59) Realization of translation differences upon sale of foreign operations 4,095 - Other comprehensive income/loss (-), net of income tax 4,248 (59) Total comprehensive income attributable to: Owners of the parent 94,468 23,148 Total comprehensive income attributable to owners of the parent arises from: Continuing operations 23,392 (11,179) Discontinued operations 71,076 34,327 Total comprehensive income, net of income tax 94,468 23,148 Consolidated statements of financial position (unaudited) (thousands of €) 31 March 2024 31 December 2023 Assets Goodwill 69,715 69,557 Intangible assets other than goodwill 125,998 127,906 Property, plant and equipment 125,059 126,321 Deferred tax assets 1,107 1,126 Non-current R&D incentives receivables 144,775 141,252 Non-current contingent consideration receivable 42,739 - Other non-current assets 65,516 29,645 Non-current assets 574,909 495,807 Inventories 80,558 73,978 Trade and other receivables 54,611 28,449 Current R&D incentives receivables 37,436 37,436 Current financial investments 3,484,560 3,517,698 Cash and cash equivalents 73,372 166,803 Escrow account 40,222 - Other current assets 15,711 15,140 Current assets from continuing operations 3,786,470 3,839,504 Assets in disposal group classified as held for sale - 22,085 Total current assets 3,786,470 3,861,589 Total assets 4,361,379 4,357,396 Equity and liabilities Share capital 293,937 293,937 Share premium account 2,736,994 2,736,994 Other reserves (5,530) (5,890) Translation differences 2,687 (1,201) Accumulated losses (133,080) (228,274) Total equity 2,895,008 2,795,566 Retirement benefit liabilities 2,270 2,293 Deferred tax liabilities 22,728 23,607 Non-current lease liabilities 3,837 4,944 Other non-current liabilities 42,887 31,570 Non-current deferred income 1,012,435 1,071,193 Non-current liabilities 1,084,157 1,133,607 Current lease liabilities 4,140 4,652 Trade and other liabilities 145,551 135,201 Current tax payable 62 56 Current deferred income 232,461 256,270 Current liabilities from continuing operations 382,214 396,179 Liabilities directly associated with assets in disposal group classified as held for sale - 32,044 Total current liabilities 382,214 428,223 Total liabilities 1,466,371 1,561,830 Total equity and liabilities 4,361,379 4,357,396 Consolidated cash flow statements (unaudited) Three months ended31 March (thousands of €) 2024 2023 Net profit of the period 90,220 23,207 Adjustment for non-cash transactions (13,367) 34,340 Adjustment for items to disclose separately under operating cash flow (25,638) (9,972) Adjustment for items to disclose under investing and financing cash flows (57,736) (2,426) Change in working capital other than deferred income (46,217) 8,273 Decrease in deferred income (81,974) (150,517) Cash used in operations (134,712) (97,095) Interest paid (432) (2,944) Interest received 13,461 5,823 Corporate taxes paid (751) (651) Net cash flows used in operating activities (122,434) (94,868) Purchase of property, plant and equipment (3,742) (4,264) Purchase of and expenditure in intangible fixed assets (2,520) (20) Purchase of current financial investments (420,158) (1,008,866) Investment income received related to current financial investments 4,653 2,345 Sale of current financial investments 489,651 722,137 Cash out from sale of subsidiaries, net of cash disposed (1,339) - Acquisition of financial assets held at fair value through profit or loss (36,880) - Net cash flows generated from/used in (-) investing activities 29,665 (288,669) Payment of lease liabilities (1,168) (1,960) Proceeds from capital and share premium increases from exercise of subscription rights - 1,770 Net cash flows used in financing activities (1,168) (190) Decrease in cash and cash equivalents (93,937) (383,727) Cash and cash equivalents at beginning of the year 166,810 508,117 Decrease in cash and cash equivalents (93,937) (383,727) Effect of exchange rate differences on cash and cash equivalents 499 (254) Cash and cash equivalents at end of the period 73,372 124,135 Consolidated statements of changes in equity (unaudited) (thousands of €) Share capital Share premium account Translation differences Other reserves Accumulated losses Total On 1 January 2023 293,604 2,735,557 (1,593) (4,853) (496,689) 2,526,026 Net profit 23,207 23,207 Other comprehensive income/loss (-) (111) 52 (59) Total comprehensive income/loss (-) (111) 52 23,207 23,148 Share-based compensation 13,663 13,663 Exercise of subscription rights 333 1,437 1,770 On 31 March 2023 293,937 2,736,994 (1,704) (4,801) (459,821) 2,564,604 On 1 January 2024 293,937 2,736,994 (1,201) (5,890) (228,274) 2,795,566 Net profit 90,220 90,220 Other comprehensive income 3,888 360 4,248 Total comprehensive income 3,888 360 90,220 94,468 Share-based compensation 4,974 4,974 On 31 March 2024 293,937 2,736,994 2,687 (5,530) (133,080) 2,895,008 1 Throughout this press release, ‘Dr. Paul Stoffels’ should be read as ‘Dr. Paul Stoffels, acting via Stoffels IMC BV’ 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, related to the acquisitions or disposals of businesses; the acquisition of financial assets held at fair value through profit or loss; 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 first three months of 2024 amounted to €125.2 million and can be reconciled to our cash flow statement by considering the decrease in cash and cash equivalents of €93.9 million, adjusted by (i) the net sale of current financial investments amounting to €69.5 million, (ii) the cash-out related to the sale of subsidiaries of €1.3 million, and (iii) the acquisition of financial assets held at fair value through profit or loss of €36.9 million.ii General and administrativeiii Sales and marketing Attachment Galapagos reports first quarter 2024 financial results

Product Sales Excluding Veklury Increased 6% Year-Over-Year to $6.1 billion Biktarvy Sales Increased 10% Year-Over-Year to $2.9 billion Oncology Sales Increased 18% Year-Over-Year to $789 million Closed CymaBay Acquisition Resulting in $3.9 billion Acquired IPR&D Charge ($3.14 Diluted EPS Impact) FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today its first quarter 2024 results of operations. “Gilead delivered another strong quarter of revenue growth in the first quarter with 6% year-over-year growth in our base business driven by HIV, Oncology and Liver Disease,” said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. “The acquisition of CymaBay brings us another potentially transformative therapy for people with liver disease, and a regulatory decision on seladelpar is expected in August. New HIV data demonstrates the continued progress in our long-acting HIV pipeline, and we look forward to providing updates on this and our broad Oncology portfolio throughout the rest of 2024.” First Quarter 2024 Financial Results Total first quarter 2024 revenue increased 5% to $6.7 billion, compared to the same period in 2023, primarily due to higher HIV, Oncology and Liver Disease sales. Diluted (loss) earnings per share (“EPS”) was $(3.34) in the first quarter 2024, compared to $0.80 in the same period in 2023. The decrease was primarily driven by an acquired in-process research and development (“IPR&D”) charge of $3.9 billion, or $3.14 per share, related to the acquisition of CymaBay Therapeutics, Inc. (“CymaBay”), as well as a pre-tax IPR&D impairment of $2.4 billion, or $1.46 per share, related to assets acquired by Gilead from Immunomedics, Inc. (“Immunomedics”) in 2020. Non-GAAP diluted (loss) EPS was $(1.32) in the first quarter 2024, compared to $1.37 in the same period in 2023. The decrease was primarily driven by the charge related to the acquisition of CymaBay. As of March 31, 2024, Gilead had $4.7 billion of cash, cash equivalents and marketable debt securities, compared to $8.4 billion as of December 31, 2023. During the first quarter 2024, Gilead generated $2.2 billion in operating cash flow. During the first quarter 2024, Gilead paid dividends of $990 million and repurchased $400 million of common stock. First Quarter 2024 Product Sales Total first quarter 2024 product sales increased 5% to $6.6 billion, compared to the same period in 2023. Total product sales, excluding Veklury, increased 6% to $6.1 billion in the first quarter 2024, compared to the same period in 2023, primarily due to higher sales in HIV, Oncology and Liver Disease. HIV product sales increased 4% to $4.3 billion in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand. Biktarvy® (bictegravir 50mg/emtricitabine 200mg (“FTC”)/tenofovir alafenamide 25mg (“TAF”)) sales increased 10% to $2.9 billion in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand in the United States, Europe and other international markets. Descovy® (FTC 200mg/TAF 25mg) sales decreased 5% to $426 million in the first quarter 2024, compared to the same period in 2023, primarily driven by lower average realized price due to channel mix, partially offset by higher demand. The Liver Disease portfolio sales increased 9% to $737 million in the first quarter 2024, compared to the same period in 2023. This was primarily driven by favorable inventory dynamics, the timing of chronic hepatitis C virus (“HCV”) purchases by the Department of Corrections in the United States, as well as higher demand across chronic hepatitis B virus (“HBV”), HCV and, in the European Union (“EU”), chronic hepatitis D virus (“HDV”). Veklury sales decreased 3% to $555 million in the first quarter 2024, compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations. Cell Therapy product sales increased 7% to $480 million in the first quarter 2024, compared to the same period in 2023. Yescarta® (axicabtagene ciloleucel) sales increased 6% to $380 million in the first quarter 2024, compared to the same period in 2023, primarily driven by strong demand in relapsed or refractory (“R/R”) large B-cell lymphoma (“LBCL”) outside the United States. Tecartus® (brexucabtagene autoleucel) sales increased 13% to $100 million in the first quarter 2024, compared to the same period in 2023, with increased demand in R/R adult acute lymphoblastic leukemia and R/R mantle cell lymphoma. Trodelvy® (sacituzumab govitecan-hziy) sales increased 39% to $309 million in the first quarter 2024, compared to the same period in 2023, primarily driven by higher demand. First Quarter 2024 Product Gross Margin, Operating Expenses and Effective Tax Rate Product gross margin was 76.6% in the first quarter 2024, compared to 77.8% in the same period in 2023, primarily driven by product mix and higher intangible asset amortization expenses. Non-GAAP product gross margin was 85.4% in the first quarter 2024, compared to 86.2% in the same period in 2023, primarily driven by product mix. Research & development (“R&D”) expenses were $1.5 billion in the first quarter 2024, compared to $1.4 billion in the same period in 2023, primarily driven by costs related to the acquisition of CymaBay and restructuring expenses. Non-GAAP R&D expenses were $1.4 billion in the first quarter 2024, flat with the same period in 2023. Acquired IPR&D expenses were $4.1 billion in the first quarter 2024, primarily driven by the $3.9 billion charge related to the acquisition of CymaBay that closed on March 22, 2024. IPR&D impairment was $2.4 billion related to the assets acquired from Immunomedics in 2020 with no similar charges in 2023. Selling, general and administrative (“SG&A”) expenses were $1.4 billion in the first quarter 2024, compared to $1.3 billion in the same period in 2023. This increase reflects costs related to the acquisition of CymaBay and restructuring expenses. Non-GAAP SG&A expenses were $1.3 billion in the first quarter 2024, flat with the same period in 2023. The effective tax rate (“ETR”) was 7.0% in the first quarter 2024, compared to 24.3% in the same period in 2023, and non-GAAP ETR was (29.8)% in the first quarter 2024, compared to 18.9% in the same period in 2023. These changes primarily reflect the non-deductible acquired IPR&D charge for CymaBay. Guidance and Outlook For the full-year, Gilead expects: (in millions, except per share amounts) 4/25/24 Guidance Low End High End Comparison to Prior Guidance Product sales $ 27,100 $ 27,500 Unchanged Product sales, excluding Veklury $ 25,800 $ 26,200 Unchanged Veklury $ 1,300 $ 1,300 Unchanged Diluted EPS $ 0.10 $ 0.50 Previously $5.15 to $5.55 Non-GAAP diluted EPS $ 3.45 $ 3.85 Previously $6.85 to $7.25 Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2024 guidance is provided in the accompanying tables. The financial guidance is subject to a number of risks and uncertainties. See the Forward-Looking Statements section below. Key Updates Since Our Last Quarterly Release Virology Presented data at the Conference on Retroviruses and Opportunistic Infections (“CROI”) across Gilead’s HIV long-acting treatment pipeline. For once-weekly oral dosing, this included Phase 2 data evaluating lenacapavir in combination with Merck & Co., Inc.’s islatravir as well as initial Phase 1b data for GS-1720, Gilead’s novel, investigational integrase inhibitor. Additionally, updated results were presented from the twice-yearly injectable Phase 1b study of lenacapavir in combination with investigational broadly neutralizing antibodies, teropavimab and zinlirvimab. Announced data at CROI evaluating Biktarvy for treatment of people with HIV and coinfections of HBV or tuberculosis, as well as results from a Phase 2/3 study evaluating once-daily oral combination of bictegravir and lenacapavir. Presented multiple real-world analyses at CROI supporting the use of Veklury for people hospitalized with COVID-19, including in immunocompromised people. Additionally, presented a real-world analysis evaluating the impact of Veklury on the risk of developing long-COVID. Announced data at CROI evaluating the safety and efficacy of Hepcludex® (bulevirtide) in people living with coinfections of HIV, HBV and HDV. In the United States and other areas outside of the EU and European Economic Area, bulevirtide is an investigational product and its safety and efficacy have not been established. Received approval by the U.S. Food and Drug Administration (“FDA”) to expand Biktarvy’s label to include treatment of people with HIV who have suppressed viral loads with known or suspected M184V/I resistance. Received approval from FDA to expand the indication for Vemlidy® (tenofovir alafenamide) to include treatment of chronic HBV in children six years and older who weigh at least 25 kg with compensated liver disease. Oncology Announced a research collaboration, option and license agreement with Merus N.V. (“Merus”) to discover novel antibody-based trispecific T-cell engagers in oncology. Entered into an exclusive license agreement with Xilio Therapeutics, Inc. (“Xilio”) to develop and commercialize Xilio’s tumor-activated IL-12 program, including investigational candidate XTX301 in advanced solid tumors. Inflammation Completed the acquisition of CymaBay for $4.3 billion in total equity value, or $3.9 billion net cash paid, adding investigational candidate seladelpar for the treatment of primary biliary cholangitis (“PBC”) to Gilead’s Liver Disease portfolio. Seladelpar is an investigational, oral, selective peroxisome proliferator-activated receptor delta (PPARδ) agonist, with Orphan Drug Designation in the United States and Europe. PPARδ has been shown to regulate critical metabolic and liver disease pathways. FDA accepted the New Drug Application for seladelpar in February 2024 for priority review, with a Prescription Drug User Fee Act target action date of August 14, 2024. Corporate Announced that Kevin Lofton is retiring from Gilead’s Board of Directors (the “Board”), effective at the conclusion of the Annual Meeting of Stockholders (“Annual Meeting”) on May 8, 2024. Anthony Welters, if re-elected at the Annual Meeting, will succeed Mr. Lofton as Lead Independent Director. Recognized as one of America’s Most JUST Companies by Just Capital and CNBC, reflecting Gilead’s longstanding commitment to operate responsibly. The Board declared a quarterly dividend of $0.77 per share of common stock for the second quarter of 2024. The dividend is payable on June 27, 2024, to stockholders of record at the close of business on June 14, 2024. Future dividends will be subject to Board approval. Certain amounts and percentages in this press release may not sum or recalculate due to rounding. Conference Call At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on and will be archived on for one year. Non-GAAP Financial Information The information presented in this document has been prepared in accordance with U.S. generally accepted accounting principles (“GAAP”), unless otherwise noted as non-GAAP. Management believes non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under GAAP. Non-GAAP financial information generally excludes acquisition-related expenses including amortization of acquired intangible assets and inventory step-up charges, and other items that are considered unusual or not representative of underlying trends of Gilead’s business, fair value adjustments of equity securities and discrete and related tax charges or benefits associated with changes in tax related laws and guidelines. Although Gilead consistently excludes the amortization of acquired intangible assets from the non-GAAP financial information, management believes that it is important for investors to understand that such intangible assets were recorded as part of acquisitions and contribute to ongoing revenue generation. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are provided in the accompanying tables. About Gilead Sciences Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19 and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California. Forward-Looking Statements Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include those relating to: Gilead’s ability to achieve its anticipated full year 2024 financial results, including as a result of the uncertainty of the amount and timing of Veklury revenues; Gilead’s ability to make progress on any of its long-term ambitions or priorities laid out in its corporate strategy; Gilead’s ability to accelerate or sustain revenues for its virology, oncology and other programs; Gilead’s ability to realize the potential benefits of acquisitions, collaborations or licensing arrangements, including the arrangements with CymaBay, Merus, and Xilio; patent protection and estimated loss of exclusivity for our products and product candidates; Gilead’s ability to initiate, progress or complete clinical trials within currently anticipated timeframes or at all, the possibility of unfavorable results from ongoing and additional clinical trials, including those involving Biktarvy, Hepcludex, Veklury, GS-1720, lenacapavir, seladelpar, teropavimab, XTX301, and zinlirvimab, and the risk that safety and efficacy data from clinical trials may not warrant further development of Gilead’s product candidates or the product candidates of Gilead’s strategic partners; Gilead’s ability to submit new drug applications for new product candidates or expanded indications in the currently anticipated timelines; Gilead’s ability to receive regulatory approvals in a timely manner or at all, including FDA approval of the New Drug Application for seladelpar, and the risk that any such approvals, if granted, may be subject to significant limitations on use; Gilead’s ability to successfully commercialize its products; the risk of potential disruptions to the manufacturing and supply chain of Gilead’s products; pricing and reimbursement pressures from government agencies and other third parties, including required rebates and other discounts; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of Gilead’s products over other therapies and may therefore be reluctant to prescribe the products, including Biktarvy and Vemlidy; and other risks identified from time to time in Gilead’s reports filed with the SEC, including annual reports on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K. In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter ended March 31, 2024 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, annual reports on Form 10-K, quarterly reports on Form 10-Q and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. The reader is cautioned that forward-looking statements are not guarantees of future performance and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®, GILEAD SCIENCES®, KITETM, AMBISOME®, ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, DESCOVY FOR PREP®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPCLUDEX®, HEPSERA®, JYSELECA®, LETAIRIS®, ODEFSEY®, SOVALDI®, STRIBILD®, SUNLENCA® , TECARTUS®, TRODELVY®, TRUVADA®, TRUVADA FOR PREP®, TYBOST®, VEKLURY®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, United States. Other trademarks are the property of their respective owners. For more information on Gilead Sciences, Inc., please visit or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235). GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) Three Months Ended March 31, (in millions, except per share amounts) 2024 2023 Revenues: Product sales $ 6,647 $ 6,306 Royalty, contract and other revenues 39 46 Total revenues 6,686 6,352 Costs and expenses: Cost of goods sold 1,552 1,401 Research and development expenses 1,520 1,447 Acquired in-process research and development expenses 4,131 481 In-process research and development impairment 2,430 — Selling, general and administrative expenses 1,375 1,319 Total costs and expenses 11,008 4,647 Operating (loss) income (4,322 ) 1,705 Interest expense 254 230 Other (income) expense, net (91 ) 174 (Loss) income before income taxes (4,486 ) 1,300 Income tax (benefit) expense (315 ) 316 Net (loss) income (4,170 ) 985 Net loss attributable to noncontrolling interest — (26 ) Net (loss) income attributable to Gilead $ (4,170 ) $ 1,010 Basic (loss) earnings per share attributable to Gilead $ (3.34 ) $ 0.81 Shares used in basic (loss) earnings per share attributable to Gilead calculation 1,247 1,248 Diluted (loss) earnings per share attributable to Gilead $ (3.34 ) $ 0.80 Shares used in diluted (loss) earnings per share attributable to Gilead calculation 1,247 1,261 Cash dividends declared per share $ 0.77 $ 0.75 Research and development expenses as a % of revenues 22.7 % 22.8 % Selling, general and administrative expenses as a % of revenues 20.6 % 20.8 % Effective tax rate 7.0 % 24.3 % GILEAD SCIENCES, INC. TOTAL REVENUE SUMMARY (unaudited) Three Months Ended March 31, (in millions, except percentages) 2024 2023 Change Product sales: HIV $ 4,342 $ 4,190 4 % Liver Disease 737 675 9 % Oncology 789 670 18 % Other 224 199 13 % Total product sales excluding Veklury 6,092 5,733 6 % Veklury 555 573 (3 )% Total product sales 6,647 6,306 5 % Royalty, contract and other revenues 39 46 (15 )% Total revenues $ 6,686 $ 6,352 5 % GILEAD SCIENCES, INC. NON-GAAP FINANCIAL INFORMATION(1) (unaudited) Three Months Ended March 31, (in millions, except percentages) 2024 2023 Change Non-GAAP: Cost of goods sold $ 974 $ 871 12 % Research and development expenses $ 1,403 $ 1,439 (2 )% Acquired IPR&D expenses(2) $ 4,131 $ 481 NM Selling, general and administrative expenses $ 1,295 $ 1,318 (2 )% Other (income) expense, net $ (104 ) $ (82 ) 27 % Diluted (loss) earnings per share attributable to Gilead $ (1.32 ) $ 1.37 NM Product gross margin 85.4 % 86.2 % -83 bps Research and development expenses as a % of revenues 21.0 % 22.6 % -166 bps Selling, general and administrative expenses as a % of revenues 19.4 % 20.7 % -138 bps Operating margin (16.7 )% 35.3 % NM Effective tax rate (29.8 )% 18.9 % NM ________________________________ NM - Not Meaningful (1) Refer to Non-GAAP Financial Information section above for further disclosures on non-GAAP financial measures. A reconciliation between GAAP and non-GAAP financial information is provided in the tables below. (2) Equal to GAAP financial information. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) Three Months Ended March 31, (in millions, except percentages and per share amounts) 2024 2023 Cost of goods sold reconciliation: GAAP cost of goods sold $ 1,552 $ 1,401 Acquisition-related – amortization(1) (579 ) (530 ) Non-GAAP cost of goods sold $ 974 $ 871 Product gross margin reconciliation: GAAP product gross margin 76.6 % 77.8 % Acquisition-related – amortization(1) 8.7 % 8.4 % Non-GAAP product gross margin 85.4 % 86.2 % Research and development expenses reconciliation: GAAP research and development expenses $ 1,520 $ 1,447 Acquisition-related – other costs(2) (66 ) (8 ) Restructuring (50 ) — Non-GAAP research and development expenses $ 1,403 $ 1,439 IPR&D impairment reconciliation: GAAP IPR&D impairment $ 2,430 $ — IPR&D impairment (2,430 ) — Non-GAAP IPR&D impairment $ — $ — Selling, general and administrative expenses reconciliation: GAAP selling, general and administrative expenses $ 1,375 $ 1,319 Acquisition-related – other costs(2) (67 ) (1 ) Restructuring (13 ) — Non-GAAP selling, general and administrative expenses $ 1,295 $ 1,318 Operating (loss) income reconciliation: GAAP operating (loss) income $ (4,322 ) $ 1,705 Acquisition-related – amortization(1) 579 530 Acquisition-related – other costs(2) 133 9 Restructuring 63 — IPR&D impairment 2,430 — Non-GAAP operating (loss) income $ (1,117 ) $ 2,243 Operating margin reconciliation: GAAP operating margin (64.6 )% 26.8 % Acquisition-related – amortization(1) 8.7 % 8.3 % Acquisition-related – other costs(2) 2.0 % 0.1 % Restructuring 0.9 % — % IPR&D impairment 36.3 % — % Non-GAAP operating margin (16.7 )% 35.3 % Other (income) expense, net reconciliation: GAAP other (income) expense, net $ (91 ) $ 174 Loss from equity securities, net (14 ) (256 ) Non-GAAP other (income) expense, net $ (104 ) $ (82 ) GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) Three Months Ended March 31, (in millions, except percentages and per share amounts) 2024 2023 Effective tax rate and income tax (benefit) expense reconciliation: GAAP effective tax rate 7.0 % 24.3 % GAAP income tax (benefit) expense $ (315 ) $ 316 Income tax effect of non-GAAP adjustments: Acquisition-related – amortization(1) 121 107 Acquisition-related – other costs(2) 30 3 Restructuring 10 — IPR&D impairment 611 — Loss from equity securities, net (39 ) (1 ) Discrete and related tax charges(3) (39 ) (29 ) Non-GAAP income tax expense $ 379 $ 396 Non-GAAP effective tax rate (29.8 )% 18.9 % Net (loss) income attributable to Gilead reconciliation: GAAP net (loss) income attributable to Gilead $ (4,170 ) $ 1,010 Acquisition-related – amortization(1) 458 422 Acquisition-related – other costs(2) 103 6 Restructuring 54 — IPR&D impairment 1,819 — Loss from equity securities, net 53 257 Discrete and related tax charges(3) 39 29 Non-GAAP net (loss) income attributable to Gilead $ (1,644 ) $ 1,725 Diluted (loss) earnings per share reconciliation: GAAP diluted (loss) earnings per share $ (3.34 ) $ 0.80 Acquisition-related – amortization(1) 0.37 0.33 Acquisition-related – other costs(2) 0.08 0.01 Restructuring 0.04 — IPR&D impairment 1.46 — Loss from equity securities, net 0.04 0.20 Discrete and related tax charges(3) 0.03 0.02 Non-GAAP diluted (loss) earnings per share $ (1.32 ) $ 1.37 Non-GAAP adjustment summary: Cost of goods sold adjustments $ 579 $ 530 Research and development expenses adjustments 117 8 IPR&D impairment adjustments 2,430 — Selling, general and administrative expenses adjustments 80 1 Total non-GAAP adjustments to costs and expenses 3,205 539 Other (income) expense, net adjustments 14 256 Total non-GAAP adjustments before income taxes 3,219 795 Income tax effect of non-GAAP adjustments above (732 ) (109 ) Discrete and related tax charges(3) 39 29 Total non-GAAP adjustments to net income attributable to Gilead $ 2,526 $ 715 ______________________________ (1) Relates to amortization of acquired intangibles and inventory step-up charges. (2) Adjustments include integration expenses, contingent consideration fair value adjustments and other expenses associated with Gilead’s acquisitions of MYR GmbH, MiroBio, Ltd., Tmunity Therapeutics, Inc. and CymaBay Therapeutics, Inc. (3) Represents discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2024 FULL-YEAR GUIDANCE(1) (unaudited) (in millions, except percentages and per share amounts) Provided February 6, 2024 Updated April 25, 2024 Projected product gross margin GAAP to non-GAAP reconciliation: GAAP projected product gross margin 76.0% - 77.0% 76.0% - 77.0% Acquisition-related expenses ~ 9.0% ~ 9.0% Non-GAAP projected product gross margin 85.0% - 86.0% 85.0% - 86.0% Projected operating income GAAP to non-GAAP reconciliation: GAAP projected operating income $8,700 - $9,200 $1,900 - $2,400 IPR&D impairment, acquisition-related and restructuring expenses ~ 2,500 ~ 5,100 Non-GAAP projected operating income $11,200 - $11,700 $7,000 - $7,500 Projected effective tax rate GAAP to non-GAAP reconciliation: GAAP projected effective tax rate ~ 21% ~ 65% Income tax effect of above non-GAAP adjustments and fair value adjustments of equity securities, and discrete and related tax adjustments (~ 2%) (~ 35%) Non-GAAP projected effective tax rate ~ 19% ~ 30% Projected diluted EPS GAAP to non-GAAP reconciliation: GAAP projected diluted EPS $5.15 - $5.55 $0.10 - $0.50 IPR&D impairment, acquisition-related and restructuring expenses, fair value adjustments of equity securities and discrete and related tax adjustments ~ 1.70 ~ 3.35 Non-GAAP projected diluted EPS $6.85 - $7.25 $3.45 - $3.85 ________________________________ (1) Our full-year guidance excludes the potential impact of any (i) acquisitions or business development transactions that have not been executed, (ii) future fair value adjustments of equity securities and (iii) discrete tax charges or benefits associated with changes in tax related laws and guidelines that have not been enacted, as Gilead is unable to project such amounts. The non-GAAP full-year guidance includes non-GAAP adjustments to actual current period results as well as adjustments for the known future impact associated with events that have already occurred, such as future amortization of our intangible assets and the future impact of discrete and related deferred tax charges or benefits primarily associated with acquired intangible assets and transfers of intangible assets from a foreign subsidiary to Ireland and the United States. GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) March 31, December 31, (in millions) 2024 2023 Assets Cash, cash equivalents and marketable debt securities $ 4,718 $ 8,428 Accounts receivable, net 4,669 4,660 Inventories 3,363 3,366 Property, plant and equipment, net 5,321 5,317 Intangible assets, net 23,428 26,454 Goodwill 8,314 8,314 Other assets 6,479 5,586 Total assets $ 56,292 $ 62,125 Liabilities and Stockholders’ Equity Current liabilities $ 13,015 $ 11,280 Long-term liabilities 25,822 28,096 Stockholders’ equity(1) 17,455 22,749 Total liabilities and stockholders’ equity $ 56,292 $ 62,125 ________________________________ (1) As of March 31, 2024 and December 31, 2023, there were 1,246 shares of common stock issued and outstanding. GILEAD SCIENCES, INC. SELECTED CASH FLOW INFORMATION (unaudited) Three Months Ended March 31, (in millions) 2024 2023 Net cash provided by operating activities $ 2,219 $ 1,744 Net cash used in investing activities (2,207 ) (826 ) Net cash used in financing activities (1,361 ) (1,406 ) Effect of exchange rate changes on cash and cash equivalents (18 ) 13 Net change in cash and cash equivalents (1,367 ) (476 ) Cash and cash equivalents at beginning of period 6,085 5,412 Cash and cash equivalents at end of period $ 4,718 $ 4,936 Three Months Ended March 31, (in millions) 2024 2023 Net cash provided by operating activities $ 2,219 $ 1,744 Capital expenditures (105 ) (109 ) Free cash flow(1) $ 2,114 $ 1,635 ________________________________ (1) Free cash flow is a non-GAAP liquidity measure. Please refer to our disclosures in the Non-GAAP Financial Information section above. GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) Three Months Ended March 31, (in millions) 2024 2023 HIV Biktarvy – U.S. $ 2,315 $ 2,161 Biktarvy – Europe 365 304 Biktarvy – Rest of World 265 212 2,946 2,677 Descovy – U.S. 371 395 Descovy – Europe 26 25 Descovy – Rest of World 29 29 426 449 Genvoya – U.S. 332 417 Genvoya – Europe 49 55 Genvoya – Rest of World 21 29 403 501 Odefsey – U.S. 223 230 Odefsey – Europe 76 76 Odefsey – Rest of World 11 11 310 317 Symtuza - Revenue share(1) – U.S. 104 98 Symtuza - Revenue share(1) – Europe 33 36 Symtuza - Revenue share(1) – Rest of World 3 4 141 138 Other HIV(2) – U.S. 60 62 Other HIV(2) – Europe 45 32 Other HIV(2) – Rest of World 12 13 117 108 Total HIV – U.S. 3,405 3,364 Total HIV – Europe 596 528 Total HIV – Rest of World 342 298 4,342 4,190 Liver Disease Sofosbuvir / Velpatasvir(3) – U.S. 248 204 Sofosbuvir / Velpatasvir(3) – Europe 79 90 Sofosbuvir / Velpatasvir(3) – Rest of World 78 90 405 385 Vemlidy – U.S. 95 87 Vemlidy – Europe 11 9 Vemlidy – Rest of World 119 103 225 199 Other Liver Disease(4) – U.S. 42 27 Other Liver Disease(4) – Europe 47 41 Other Liver Disease(4) – Rest of World 19 23 107 91 Total Liver Disease – U.S. 385 318 Total Liver Disease – Europe 137 140 Total Liver Disease – Rest of World 215 217 737 675 Veklury Veklury – U.S. 315 252 Veklury – Europe 70 111 Veklury – Rest of World 169 209 555 573 GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) Three Months Ended March 31, (in millions) 2024 2023 Oncology Cell Therapy Tecartus – U.S. 55 59 Tecartus – Europe 36 27 Tecartus – Rest of World 8 3 100 89 Yescarta – U.S. 170 210 Yescarta – Europe 158 121 Yescarta – Rest of World 52 28 380 359 Total Cell Therapy – U.S. 225 269 Total Cell Therapy – Europe 195 148 Total Cell Therapy – Rest of World 60 31 480 448 Trodelvy Trodelvy – U.S. 206 162 Trodelvy – Europe 68 54 Trodelvy – Rest of World 36 6 309 222 Total Oncology – U.S. 431 431 Total Oncology – Europe 262 202 Total Oncology – Rest of World 96 37 789 670 Other AmBisome – U.S. 14 6 AmBisome – Europe 70 60 AmBisome – Rest of World 60 49 144 116 Other(5) – U.S. 59 62 Other(5) – Europe 9 12 Other(5) – Rest of World 12 9 80 83 Total Other – U.S. 73 69 Total Other – Europe 79 72 Total Other – Rest of World 71 58 224 199 Total product sales – U.S. 4,609 4,434 Total product sales – Europe 1,144 1,053 Total product sales – Rest of World 894 819 $ 6,647 $ 6,306 ______________________________ (1) Represents Gilead’s revenue from cobicistat (“C”), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland Unlimited Company. (2) Includes Atripla, Complera/Eviplera, Emtriva, Sunlenca, Stribild, Truvada and Tybost. (3) Includes Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC (“Asegua”). (4) Includes ledipasvir/sofosbuvir (Harvoni and the authorized generic version of Harvoni sold by Asegua), Hepcludex, Hepsera, Sovaldi, Viread and Vosevi. (5) Includes Cayston, Jyseleca, Letairis, Ranexa and Zydelig.