On February 11, 2025 BostonGene, a leading provider of AI-driven molecular and immune profiling solutions, reported a collaboration with BeiGene Ltd., a global oncology company that intends to change its name to BeOne Medicines Ltd (Press release, BostonGene, FEB 11, 2025, View Source [SID1234650184]). The collaboration centers on identifying tumor-based biomarkers associated with response and resistance in Mantle Cell Lymphoma (MCL).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This initiative seeks to explain the molecular drivers of therapeutic response and resistance in MCL, a rare and aggressive subtype of B-cell lymphoma, which presents unique challenges due to its high relapse rates and frequent resistance to conventional therapies. By analyzing tumor-specific genomic alterations, immune microenvironment dynamics and clinical outcomes, the collaboration aims to generate actionable insights that can guide precision medicine approaches.

BostonGene will utilize its multi-scale, multi-modal foundation AI platform, integrating next-generation techniques such as whole-exome and RNA sequencing and targeted high-depth hematological cancer panel, to generate comprehensive genomic, transcriptomic, and immunological clinical profiles. The study aims to identify predictive and prognostic biomarker signatures for therapeutic response and disease progression, informing future treatment strategies in MCL.

"At BostonGene, we are dedicated to unraveling the complexity of hematologic malignancies through data-driven molecular and clinical analysis," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our work with BeiGene will facilitate the identification of clinically actionable biomarkers, with the goal of advancing personalized therapeutic approaches and improving outcomes for MCL patients."

On February 11, 2025 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the fourth quarter and fiscal year of 2024, provided an update on progress toward achieving key corporate objectives, and outlined its commercial, clinical and pipeline development milestones (Press release, Exelixis, FEB 11, 2025, View Source [SID1234650169]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Exelixis delivered a strong fourth quarter of 2024, positioning us well to maximize success in 2025," said Michael M. Morrissey, Ph.D., President and Chief Executive Officer, Exelixis. "Due to the continued outsized performance of the cabozantinib franchise, we generated net product revenues of $515 million and $1.81 billion in the fourth quarter and full year 2024, respectively. Our current 2025 guidance, which does not include any impact from a potential U.S. regulatory approval for CABOMETYX in advanced neuroendocrine tumors, points to solid growth for the cabozantinib franchise. We’re launch-ready for this important indication ahead of an April 3, 2025 PDUFA target action date for our U.S. regulatory filing."

Dr. Morrissey continued: "We expect zanzalintinib to take center stage in 2025 as our next franchise opportunity that could improve standards of care for patients with cancer. Our anticipated zanzalintinib pivotal data milestones include top-line results from STELLAR-303 in colorectal cancer and STELLAR-304 in non-clear cell renal cell carcinoma, and a decision to advance to the phase 3 portion of STELLAR-305 in head and neck cancer, all in the second half of the year pending event rates for each trial. We are also excited to deliver on our plan to initiate the STELLAR-311 trial of zanzalintinib in neuroendocrine tumors in the first half of 2025 and anticipate Merck to initiate two renal cell carcinoma studies evaluating zanzalintinib plus belzutifan this year. With so much in store for 2025, the entire Exelixis team has a singular focus on achieving our mission to help cancer patients recover stronger and live longer."

Fourth Quarter and Fiscal Year 2024 Financial Results

Total revenues for the quarter and year ended December 31, 2024 were $566.8 million and $2,168.7 million, as compared to $479.7 million and $1,830.2 million for the comparable periods in 2023.

Total revenues for the quarter and year ended December 31, 2024 included net product revenues of $515.2 million and $1,809.4 million, respectively, as compared to $429.3 million and $1,628.9 million for the comparable periods in 2023. The increases in net product revenues, for both periods, were primarily due to an increase in sales volume and an increase in average net selling price.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $51.5 million for the quarter ended December 31, 2024, as compared to $50.3 million for the comparable period in 2023. The increase in collaboration revenues was primarily related to royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS and Takeda Pharmaceutical Company Limited, partially offset by a decrease in development cost reimbursements earned. Collaboration revenues were $359.3 million for the year ended December 31, 2024, as compared to $201.3 million for the comparable period in 2023. The increase was primarily related to the recognition of milestone-related revenues and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, partially offset by a decrease in development cost reimbursements earned.

Research and development expenses for the quarter ended December 31, 2024 were $249.0 million, as compared to $244.7 million for the comparable period in 2023. The increase in research and development expenses for the quarter was primarily related to increases in license and other collaboration costs, personnel expenses and higher manufacturing costs to support Exelixis’ development candidates, partially offset by decreases in clinical trial costs, and consulting and outside services. Research and development expenses for the year ended December 31, 2024 were $910.4 million, as compared to $1,044.1 million for the comparable period in 2023. The decrease in research and development expenses for the year was primarily related to decreases in license and other collaboration costs, personnel expenses, consulting and outside services, and laboratory supplies, partially offset by higher manufacturing costs to support Exelixis’ development candidates and clinical trial costs.

Selling, general and administrative expenses for the quarter ended December 31, 2024 were $134.3 million, as compared to $131.4 million for the comparable period in 2023. The increase in selling, general and administrative expenses for the quarter was primarily related to increases in personnel expenses and stock-based compensation expenses, partially offset by decreases in corporate giving and legal and advisory fees. Selling, general and administrative expenses for the year ended December 31, 2024 were $492.1 million, as compared to $542.7 million for the comparable period in 2023. The decrease in selling, general and administrative expenses for the year was primarily related to decreases in corporate giving, legal and advisory fees, technology costs, and stock-based compensation expenses, partially offset by an increase in personnel expenses.

Provision for income taxes for the quarter and year ended December 31, 2024 was $44.9 million and $160.4 million, respectively, as compared to $17.5 million and $49.8 million for the comparable periods in 2023, primarily due to an increase in pre-tax income.

GAAP net income for the quarter ended December 31, 2024 was $139.9 million, or $0.49 per share, basic and $0.48 per share, diluted, as compared to GAAP net income of $85.5 million, or $0.28 per share, basic and $0.27 per share, diluted, for the comparable period in 2023. GAAP net income for the year ended December 31, 2024 was $521.3 million, or $1.80 per share, basic and $1.76 per share diluted, as compared to GAAP net income of $207.8 million, or $0.65 per share, basic and diluted, for the comparable period in 2023.

Non-GAAP net income for the quarter ended December 31, 2024 was $160.3 million, or $0.56 per share, basic and $0.55 per share, diluted, as compared to non-GAAP net income of $104.2 million, or $0.34 per share, basic and $0.33 per share diluted, for the comparable period in 2023. Non-GAAP net income for the year ended December 31, 2024 was $593.6 million, or $2.05 per share, basic and $2.00 per share, diluted, as compared to non-GAAP net income of $289.4 million or $0.91 per share, basic and $0.90 per share, diluted, for the comparable period in 2023.

Non-GAAP Financial Measures

To supplement Exelixis’ financial results presented in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Exelixis presents non-GAAP net income (and the related per share measures), which excludes from GAAP net income (and the related per share measures) stock-based compensation expense, adjusted for the related income tax effect for all periods presented.

Exelixis believes that the presentation of these non-GAAP financial measures provides useful supplementary information to, and facilitates additional analysis by, investors. In particular, Exelixis believes that these non-GAAP financial measures, when considered together with its financial information prepared in accordance with GAAP, can enhance investors’ and analysts’ ability to meaningfully compare Exelixis’ results from period to period, and to identify operating trends in Exelixis’ business. Exelixis has excluded stock-based compensation expense, adjusted for the related income tax effect, because it is a non-cash item that may vary significantly from period to period as a result of changes not directly or immediately related to the operational performance for the periods presented. Exelixis also regularly uses these non-GAAP financial measures internally to understand, manage and evaluate its business and to make operating decisions.

These non-GAAP financial measures are in addition to, not a substitute for, or superior to, measures of financial performance prepared in accordance with GAAP. Exelixis encourages investors to carefully consider its results under GAAP, as well as its supplemental non-GAAP financial information and the reconciliation between these presentations, to more fully understand Exelixis’ business. Reconciliations between GAAP and non-GAAP results are presented in the tables of this release.

2025 Financial Guidance

Exelixis is maintaining the previously provided financial guidance for fiscal year 2025. Net product and total revenues guidance do not currently reflect any revenues resulting from a potential U.S. regulatory approval and commercial launch of CABOMETYX (cabozantinib) for the treatment of patients with previously treated advanced neuroendocrine tumors (NET). The U.S. Food and Drug Administration (FDA) is currently reviewing Exelixis’ supplemental New Drug Application (sNDA) for this proposed indication, with a Prescription Drug User Fee Act (PDUFA) target action date of April 3, 2025.

Total revenues

$2.15 billion – $2.25 billion

Net product revenues

$1.95 billion – $2.05 billion(1)

Cost of goods sold

4% – 5% of net product revenues

Research and development expenses

$925 million – $975 million(2)

Selling, general and administrative expenses

$475 million – $525 million(3)

Effective tax rate

21% – 23%

____________________
(1)

Exelixis’ 2025 net product revenues guidance range includes the impact of a U.S. wholesale acquisition cost increase of 2.8% for CABOMETYX effective Jan. 1, 2025.

(2)

Includes $40.0 million of non-cash stock-based compensation expense.

(3)

Includes $60.0 million of non-cash stock-based compensation expense.

Cabozantinib Highlights

Cabozantinib Franchise Net Product Revenues and Royalties. Net product revenues generated by the cabozantinib franchise in the U.S. were $515.2 million during the fourth quarter of 2024, with net product revenues of $512.8 million from CABOMETYX and $2.4 million from COMETRIQ (cabozantinib). For the year ended December 31, 2024, net product revenues generated by the cabozantinib franchise in the U.S. were $1,809.4 million, with net product revenues of $1,798.2 million from CABOMETYX and $11.2 million from COMETRIQ. In 2024, global cabozantinib franchise net product revenues generated by Exelixis and its partners exceeded $2.5 billion. Based upon cabozantinib-related net product revenues generated by Exelixis’ collaboration partners during the quarter and year ended December 31, 2024, Exelixis earned $44.4 million and $166.9 million, respectively, in royalty revenues.

Detailed Results from Subgroup Analysis of Phase 3 CABINET Pivotal Study Evaluating Cabozantinib in Advanced Gastrointestinal (GI) NET Presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI 2025). In January 2025, results from a subgroup analysis of the CABINET study of patients with extra-pancreatic neuroendocrine tumors (epNET) arising in the GI tract were featured in a poster session at ASCO (Free ASCO Whitepaper) GI 2025. The analysis showed cabozantinib was associated with an improvement in progression-free survival (PFS) compared with placebo in patients with advanced GI NET, which was a subgroup of the epNET cohort. Earlier in January, the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Neuroendocrine and Adrenal Tumors were updated to include cabozantinib as category 1 for certain types of NET following specific treatments, and as a category 2A preferred regimen for several other forms of advanced NET, depending on site of origin and grade.

Cabozantinib Data Presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2025 Genitourinary Cancers Symposium (ASCO GU). In February 2025, cabozantinib will be the subject of 16 presentations and poster sessions at this year’s ASCO (Free ASCO Whitepaper) GU, which is being held from February 13-15 in San Francisco. Notable presentations will include final follow-up results from the CheckMate -9ER trial (median follow-up of 67.6 months).

Pipeline Highlights

Encouraging Results from Phase 1b/2 STELLAR-001 Trial Evaluating Zanzalintinib Alone or in Combination with Atezolizumab (Tecentriq) in Metastatic Colorectal Cancer (CRC) Presented at ASCO (Free ASCO Whitepaper) GI 2025. In January 2025, results from an expansion cohort of the phase 1b/2 STELLAR-001 trial evaluating zanzalintinib alone or in combination with atezolizumab in patients with previously treated metastatic CRC were presented during a poster session at ASCO (Free ASCO Whitepaper) GI 2025. This cohort of the STELLAR-001 trial included 107 patients randomized 1:1 to receive single-agent zanzalintinib or zanzalintinib in combination with atezolizumab. Patients had unresectable, locally advanced or metastatic RAS wild-type CRC that is non-microsatellite instability-high or non-mismatch repair-deficient. Results from the presentation demonstrated that all efficacy parameters, including objective response rate, PFS and overall survival (OS) favored the combination of zanzalintinib plus atezolizumab versus zanzalintinib monotherapy in the overall population, as well as in a subgroup of patients without liver metastases. These data provide insights into the contribution of components for the zanzalintinib plus atezolizumab combination and support zanzalintinib’s ongoing pivotal development in metastatic CRC. Exelixis anticipates disclosing additional data from zanzalintinib’s phase 1b/2 studies in the first half of 2025.

Initiation of Phase 1 Clinical Trial Evaluating XL495 in Patients with Advanced Solid Tumors. In November 2024, Exelixis announced the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XL495 in patients with advanced solid tumors. XL495 is a novel, potent, small molecule inhibitor of PKMYT1. The dose-escalation stage of this phase 1 study is designed to determine the maximum tolerated dose of XL495. The expansion cohorts are designed to further assess the tolerability and activity of XL495 both as monotherapy and in combination with select cytotoxic agents in tumor-specific indications. Exelixis plans to present data from the XL495 program, as well as XL309 (potentially best-in-class small molecule inhibitor of USP1) and XB010 (5T4-targeting antibody-drug conjugate), at a scientific meeting in 2025.

Corporate Highlights

Clinical Development Collaboration with Merck to Evaluate Zanzalintinib in Combination with KEYTRUDA (pembrolizumab) in Head and Neck Cancer and with WELIREG (belzutifan) in Renal Cell Carcinoma (RCC). In October 2024, Exelixis and Merck (known as MSD outside of the U.S. and Canada) announced a clinical development collaboration to evaluate zanzalintinib in combination with KEYTRUDA in head and neck squamous cell carcinoma (HNSCC), and zanzalintinib with WELIREG in RCC. Under the terms of the collaboration, Merck will supply KEYTRUDA, its anti-PD-1 therapy, for the ongoing, Exelixis-sponsored phase 3 STELLAR-305 pivotal trial in previously untreated PD-L1 positive recurrent or metastatic HNSCC. In addition, Merck will sponsor a phase 1/2 trial and two phase 3 pivotal trials evaluating zanzalintinib in combination with WELIREG, its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, in RCC. Merck will fund one of these phase 3 studies, and Exelixis will co-fund the phase 1/2 trial and the other phase 3 study, as well as supply zanzalintinib and cabozantinib. Exelixis maintains all global commercial and marketing rights to zanzalintinib.

Favorable Ruling in Second Cabozantinib Abbreviated New Drug Application (ANDA) Litigation Against MSN Pharmaceuticals, Inc. (MSN). In October 2024, the U.S. District Court for the District of Delaware (the District Court) ruled in Exelixis’ favor, rejecting MSN’s challenge to three Orange Book-listed patents related to cabozantinib (U.S. Patents No. 11,091,439 (crystalline salt forms), 11,091,440 (pharmaceutical composition) and 11,098,015 (methods of treatment)), which expire January 15, 2030. The District Court’s decision follows an earlier stipulation that MSN’s proposed generic cabozantinib product (ANDA No. 213878) infringes the ’439, ’440, and ’015 patents. The District Court also ruled that Exelixis’ U.S. Patent No. 11,298,349 (pharmaceutical composition) is not invalid and not infringed by MSN’s proposed ANDA product. To Exelixis’ knowledge, the FDA has not yet granted tentative approval of MSN’s proposed ANDA product. On October 23, 2024, the District Court entered final judgment reflecting the opinion. Based on the District Court’s final judgment should the FDA ultimately approve MSN’s ANDA, the effective date of any such approval and commercial launch in the U.S. of MSN’s proposed ANDA product shall not be a date earlier than January 15, 2030, subject to Exelixis’ potential additional regulatory exclusivity. On November 22, 2024, MSN noticed an appeal to the Court of Appeals for the Federal Circuit and Exelixis noticed a cross-appeal on November 26, 2024. In February 2025, Exelixis received notice that MSN submitted to the FDA a Paragraph IV certification regarding another Exelixis Orange Book patent: U.S. Patent No. 12,128,039 (low impurity), which expires in 2032. Exelixis is evaluating next steps and will continue to vigorously defend its cabozantinib intellectual property estate.

Stock Repurchase Program. Under the ongoing 2024-25 $500 million stock repurchase program announced in August 2024, Exelixis has repurchased $205.6 million of the company’s common stock, at an average price of $33.62 per share as of the end of fiscal year 2024. This is the third stock repurchase program undertaken by Exelixis since March 2023. Stock repurchases under this program may be made from time to time through a variety of methods, which may include open market purchases, in block trades, accelerated stock repurchase transactions, exchange transactions, or any combination of such methods. The timing and amount of any stock repurchases under the stock repurchase program will be based on a variety of factors, including ongoing assessments of the capital needs of the business, alternative investment opportunities, the market price of Exelixis’ common stock and general market conditions.

Announcement of Key Priorities and Anticipated Milestones for 2025. In January 2025, Exelixis announced its key priorities and anticipated milestones for 2025, including: the potential commercial launch of CABOMETYX for the treatment of patients with previously treated advanced NET following completion of the FDA’s review of Exelixis’ sNDA, which has a PDUFA action date of April 3, 2025; expansion of zanzalintinib’s pivotal development program with six ongoing or planned pivotal trials, including two pivotal RCC studies with Merck and additional studies to be announced in 2025, as well as initial clinical data readouts from the phase 1b/2 STELLAR-001 and STELLAR-002 clinical studies in the first half of the year and clinical updates from the pivotal STELLAR-303, -304 and -305 trials in the second half of 2025; accelerating the phase 1 development of XL309 as a potential therapy for tumors that have become refractory to PARP inhibitor (PARPi) therapy, as well as in combination with PARPi agents to deepen and prolong responses; continued progress of phase 1 clinical trials for XB010 and XL495; potentially filing three Investigational New Drug applications for the XB628 PD-L1-NKG2A bispecific antibody, XB064 ILT-2 monoclonal antibody and XB371 TF-topoisomerase I inhibitor antibody-drug conjugate. Exelixis presented the details of its key priorities and anticipated milestones at the 43rd Annual J.P. Morgan Healthcare Conference.

Basis of Presentation

Exelixis has adopted a 52- or 53-week fiscal year that generally ends on the Friday closest to December 31. For convenience, references in this press release as of and for the fiscal periods ended January 3, 2025 and December 29, 2023, are indicated as being as of and for the periods ended December 31, 2024 and 2023, respectively.

Conference Call and Webcast

Exelixis management will discuss the company’s financial results for the fourth quarter and fiscal year 2024 and provide a general business update during a conference call beginning at 5:00 p.m. ET / 2:00 p.m. PT today, Tuesday, February 11, 2025.

To access the conference call, please register using this link. Upon registration, a dial-in number and unique PIN will be provided to join the call. To access the live webcast link, log onto www.exelixis.com and proceed to the Event Calendar page under the Investors & News heading. A webcast replay of the conference call will also be archived on www.exelixis.com for one year.

On February 11, 2025 Bayer reported that it will present new data from its prostate cancer portfolio at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary (ASCO GU) Cancers Symposium, taking place in San Francisco, California, from February 13-15, 2025 (Press release, Bayer, FEB 11, 2025, View Source [SID1234650185]). These presentations reinforce Bayer´s commitment to advancing treatments across different stages of prostate cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Data will include a subgroup analysis from the investigational Phase III ARANOTE trial, evaluating the efficacy and safety of NUBEQA (darolutamide) and androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume. Subgroup analyses from the investigational Phase III ARASENS trial will be presented, including evaluating age-related efficacy and safety of NUBEQA plus ADT and docetaxel in patients with mHSPC and an analysis of concomitant granulocyte colony-stimulating factor (G-CSF) use in maintaining an efficacious dose and safe delivery of docetaxel in combination with NUBEQA in patients with mHSPC.

Lead-in phase results will be presented from the investigational Phase II ARAMON trial, investigating NUBEQA monotherapy in patients with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR) and other data to be presented will focus on clinical use and outcomes of androgen-receptor pathway inhibitors triplet therapy for mHSPC. A trial-in-progress update will also be presented for the ongoing investigational Phase III ARASTEP trial investigating NUBEQA plus ADT in patients with high-risk BCR of prostate cancer.

NUBEQA is indicated in the U.S. for the treatment of adult patients with mHSPC in combination with docetaxel and for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC).1

In radiopharmaceuticals, investigator-initiated research will be presented on XOFIGO (radium-223 dichloride) without ADT in patients with BCR and positron emission tomography (PET) findings in the bones. Investigator-initiated research will be presented evaluating the safety and efficacy of retreatment of metastatic castration-resistant prostate cancer (mCRPC) patients with XOFIGO therapy in daily practice. Data from three Real World Evidence studies, reviewing data from over 30 observational studies, will be presented.

XOFIGO is indicated in the U.S. for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.2

Details on selected abstracts from Bayer at the 2025 ASCO (Free ASCO Whitepaper) GU Cancers Symposium are listed below:

NUBEQA (darolutamide)

Darolutamide plus ADT in patients with metastatic hormone-sensitive prostate cancer (mHSPC) by disease volume: Subgroup analysis of the phase 3 ARANOTE trial
Abstract: 151; February 13. 11:25 AM – 12:45 PM PST
Age-related efficacy and safety of darolutamide plus androgen-deprivation therapy (ADT) and docetaxel in patients with metastatic hormone-sensitive prostate cancer (mHSPC): a subgroup analysis of ARASENS
Abstract: 143; February 13. 11:25 AM – 12:45 PM PST
Concomitant G-CSF use in maintaining an efficacious dose and safe delivery of docetaxel in combination with darolutamide in patients with metastatic hormone sensitive prostate cancer (mHSPC): ARASENS, a phase 3 study
Abstract: 152; February 13. 11:25 AM – 12:45 PM PST
Darolutamide monotherapy in patients with castration-sensitive prostate cancer (CSPC) after biochemical recurrence (BCR): ARAMON lead-in phase results
Abstract: 150; February 13. 11:25 AM – 12:45 PM PST
Clinical use and outcomes of Androgen-Receptor pAthwAy inhibitors Triplet therapy for metastatic hormone-sensitive prostate cancer (ARAAT) – Real World Evidence (RWE)
Abstract: 66; February 13. 11:25 AM – 12:45 PM PST
Darolutamide plus androgen-deprivation therapy (ADT) in patients with high-risk biochemical recurrence (BCR) of prostate cancer: A phase 3, randomized, double-blind, placebo-controlled study (ARASTEP) – Trial in Progress (TiP)
Abstract: TPS432; February 13. 11:25 AM – 12:45 PM PST
XOFIGO (radium-223 dichloride)

Re-treatment of metastatic castration-resistant prostate cancer patients with radium-223 therapy in daily practice – Investigator-Initiated Research (IIR)
Abstract: 183; February 13. 11:25 AM – 12:45 PM PST
Radium 223 without Androgen Deprivation Therapy (ADT) in Patients (Pts) with Biochemically Recurrent Prostate Cancer (BCR) and PET Findings in the Bones – Investigator-Initiated Research (IIR)
Abstract: 180; February 13. 11:25 AM -12:45 PM PST
Effectiveness and safety of radium-223 in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 48 real-world studies – Real World Evidence (RWE)
Abstract: 81; February 13. 11:25 AM – 12:45 PM PST
Real-world treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC) who previously progressed from metastatic hormone-sensitive prostate cancer (mHSPC) between 2020 to 2023 in the United States – Real World Evidence (RWE)
Abstract: 99; February 13. 11:25 AM -12:45 PM PST
Treatment patterns and survival in men with metastatic castration-resistant prostate cancer (mCRPC): A systematic literature review of 35 real-world observational studies – Real World Evidence (RWE)
Abstract: 101; February 13. 11:25 AM -12:45 PM PST
About NUBEQA (darolutamide)1
NUBEQA (darolutamide) is an androgen receptor inhibitor (ARi) with a distinct chemical structure that competitively inhibits androgen binding, AR nuclear translocation, and AR-mediated transcription.

NUBEQA is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

NUBEQA is an androgen receptor inhibitor indicated for the treatment of adult patients with:

Non-metastatic castration-resistant prostate cancer (nmCRPC)
Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel
IMPORTANT SAFETY INFORMATION

Warnings & Precautions
Ischemic Heart Disease – In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA vs. 0.2% receiving placebo. In a study of patients with mHSPC (ARASENS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA with docetaxel vs. 2% receiving placebo with docetaxel, including Grade 3-4 events in 1.3% vs. 1.1%, respectively. Ischemic events led to death in 0.3% of patients receiving NUBEQA with docetaxel vs. 0% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease.

Seizure – In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receiving NUBEQA vs. 0.2% receiving placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUBEQA with docetaxel, including one Grade 3 event, vs. 0.2% receiving placebo with docetaxel. Seizure occurred 38 to 340 days after initiation of NUBEQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment.

Embryo-Fetal Toxicity – Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contraception during treatment with NUBEQA and for 1 week after the last dose.

Adverse Reactions
In ARAMIS, serious adverse reactions occurred in 25% of patients receiving NUBEQA vs. 20% of patients receiving placebo. Serious adverse reactions in ≥1% of patients who received NUBEQA included urinary retention, pneumonia, and hematuria. Fatal adverse reactions occurred in 3.9% of patients receiving NUBEQA vs. 3.2% of patients receiving placebo. Fatal adverse reactions in patients who received NUBEQA included death (0.4%), cardiac failure (0.3%), cardiac arrest (0.2%), general physical health deterioration (0.2%), and pulmonary embolism (0.2%). The most common adverse reactions (>2% with a ≥2% increase over placebo), including laboratory test abnormalities, were increased AST, decreased neutrophil count, fatigue, increased bilirubin, pain in extremity and rash. Clinically relevant adverse reactions occurring in ≥2% of patients treated with NUBEQA included ischemic heart disease and heart failure.

In ARASENS, serious adverse reactions occurred in 45% of patients receiving NUBEQA with docetaxel vs. 42% of patients receiving placebo with docetaxel. Serious adverse reactions in ≥2% of patients who received NUBEQA with docetaxel included febrile neutropenia (6%), decreased neutrophil count (2.8%), musculoskeletal pain (2.6%), and pneumonia (2.6%). Fatal adverse reactions occurred in 4% of patients receiving NUBEQA with docetaxel vs. 4% of patients receiving placebo with docetaxel. Fatal adverse reactions in patients who received NUBEQA included COVID-19/COVID-19 pneumonia (0.8%), myocardial infarction (0.3%), and sudden death (0.3%). The most common adverse reactions (≥10% with a ≥2% increase over placebo with docetaxel) were constipation, rash, decreased appetite, hemorrhage, increased weight, and hypertension. The most common laboratory test abnormalities (≥30%) were anemia, hyperglycemia, decreased lymphocyte count, decreased neutrophil count, increased AST, increased ALT, and hypocalcemia. Clinically relevant adverse reactions in <10% of patients who received NUBEQA with docetaxel included fractures, ischemic heart disease, seizures, and drug-induced liver injury.

Drug Interactions
Effect of Other Drugs on NUBEQA – Combined P-gp and strong or moderate CYP3A4 inducers decrease NUBEQA exposure, which may decrease NUBEQA activity. Avoid concomitant use.

Combined P-gp and strong CYP3A4 inhibitors increase NUBEQA exposure, which may increase the risk of NUBEQA adverse reactions. Monitor more frequently and modify NUBEQA dose as needed.

Effects of NUBEQA on Other Drugs – NUBEQA inhibits breast cancer resistance protein (BCRP) transporter. Concomitant use increases exposure (AUC) and maximal concentration of BCRP substrates, which may increase the risk of BCRP substrate-related toxicities. Avoid concomitant use where possible. If used together, monitor more frequently for adverse reactions, and consider dose reduction of the BCRP substrate.

NUBEQA inhibits OATP1B1 and OATP1B3 transporters. Concomitant use may increase plasma concentrations of OATP1B1 or OATP1B3 substrates. Monitor more frequently for adverse reactions and consider dose reduction of these substrates.

Review the Prescribing Information of drugs that are BCRP, OATP1B1, and OATP1B3 substrates when used concomitantly with NUBEQA.

For important risk and use information about NUBEQA, please see the accompanying full Prescribing Information.

About Metastatic Hormone-Sensitive Prostate Cancer
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide.3 In 2020, an estimated 1.4 million men were diagnosed with prostate cancer, including almost 300,000 cases in the U.S., and about 375,000 died from the disease worldwide.4,5

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. Upon relapse when the disease will metastasize or spread, androgen deprivation therapy (ADT) is the cornerstone of treatment for this hormone-sensitive disease. Approximately 10% of men will already present with mHSPC when first diagnosed.6,7,8 Men with metastatic hormone-sensitive prostate cancer (mHSPC) will start their treatment with hormone therapy, such as ADT, androgen receptor inhibitor (ARi) plus ADT or a combination of the chemotherapy docetaxel and ADT. Despite this treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer (CRPC), a condition with limited survival.

About XOFIGO (radium Ra 223 dichloride) Injection2
Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions:

Bone Marrow Suppression: In the phase 3 ALSYMPCA trial, 2% of patients in the Xofigo arm experienced bone marrow failure or ongoing pancytopenia, compared to no patients treated with placebo. There were two deaths due to bone marrow failure. For 7 of 13 patients treated with Xofigo bone marrow failure was ongoing at the time of death. Among the 13 patients who experienced bone marrow failure, 54% required blood transfusions. Four percent (4%) of patients in the Xofigo arm and 2% in the placebo arm permanently discontinued therapy due to bone marrow suppression. In the randomized trial, deaths related to vascular hemorrhage in association with myelosuppression were observed in 1% of Xofigo-treated patients compared to 0.3% of patients treated with placebo. The incidence of infection-related deaths (2%), serious infections (10%), and febrile neutropenia (<1%) was similar for patients treated with Xofigo and placebo. Myelosuppression–notably thrombocytopenia, neutropenia, pancytopenia, and leukopenia–has been reported in patients treated with Xofigo.
Monitor patients with evidence of compromised bone marrow reserve closely and provide supportive care measures when clinically indicated. Discontinue Xofigo in patients who experience life-threatening complications despite supportive care for bone marrow failure

Hematological Evaluation: Monitor blood counts at baseline and prior to every dose of Xofigo. Prior to first administering Xofigo, the absolute neutrophil count (ANC) should be ≥1.5 × 109/L, the platelet count ≥100 × 109/L, and hemoglobin ≥10 g/dL. Prior to subsequent administrations, the ANC should be ≥1 × 109/L and the platelet count ≥50 × 109/L. Discontinue Xofigo if hematologic values do not recover within 6 to 8 weeks after the last administration despite receiving supportive care
Concomitant Use With Chemotherapy: Safety and efficacy of concomitant
chemotherapy with Xofigo have not been established. Outside of a clinical trial,
concomitant use of Xofigo in patients on chemotherapy is not recommended due to the potential for additive myelosuppression. If chemotherapy, other systemic radioisotopes, or hemibody external radiotherapy are administered during the treatment period, Xofigo should be discontinued
Increased Fractures and Mortality in Combination With Abiraterone Plus Prednisone/Prednisolone: Xofigo is not recommended for use in combination with abiraterone acetate plus prednisone/prednisolone outside of clinical trials. At the primary analysis of the Phase 3 ERA-223 study that evaluated concurrent initiation of Xofigo in combination with abiraterone acetate plus prednisone/prednisolone in 806 asymptomatic or mildly symptomatic mCRPC patients, an increased incidence of fractures (28.6% vs 11.4%) and deaths (38.5% vs 35.5%) have been observed in patients who received Xofigo in combination with abiraterone acetate plus prednisone/prednisolone compared to patients who received placebo in combination with abiraterone acetate plus prednisone/prednisolone. Safety and efficacy with the combination of Xofigo and agents other than gonadotropin-releasing hormone analogues have not been established
Embryo-Fetal Toxicity: The safety and efficacy of Xofigo have not been established in females. Xofigo can cause fetal harm when administered to a pregnant female. Advise pregnant females and females of reproductive potential of the potential risk to a fetus. Advise male patients to use condoms and their female partners of reproductive potential to use effective contraception during and for 6 months after completing treatment with Xofigo
Administration and Radiation Protection: Xofigo should be received, used, and administered only by authorized persons in designated clinical settings. The administration of Xofigo is associated with potential risks to other persons from radiation or contamination from spills of bodily fluids such as urine, feces, or vomit. Therefore, radiation protection precautions must be taken in accordance with national and local regulations

Fluid Status: Dehydration occurred in 3% of patients on Xofigo and 1% of patients on placebo. Xofigo increases adverse reactions such as diarrhea, nausea, and vomiting, which may result in dehydration. Monitor patients’ oral intake and fluid status carefully and promptly treat patients who display signs or symptoms of dehydration or hypovolemia

Injection Site Reactions: Erythema, pain, and edema at the injection site were reported in 1% of patients on Xofigo

Secondary Malignant Neoplasms: Xofigo contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure may be associated with an increased risk of cancer and hereditary defects. Due to its mechanism of action and neoplastic changes, including osteosarcomas, in rats following administration of radium-223 dichloride, Xofigo may increase the risk of osteosarcoma or other secondary malignant neoplasms. However, the overall incidence of new malignancies in the randomized trial was lower on the Xofigo arm compared to placebo (<1% vs 2%; respectively), but the expected latency period for the development of secondary malignancies exceeds the duration of follow-up for patients on the trial

Subsequent Treatment With Cytotoxic Chemotherapy: In the randomized clinical trial, 16% of patients in the Xofigo group and 18% of patients in the placebo group received cytotoxic chemotherapy after completion of study treatments. Adequate safety monitoring and laboratory testing was not performed to assess how patients treated with Xofigo will tolerate subsequent cytotoxic chemotherapy

Adverse Reactions: The most common adverse reactions (≥10%) in the Xofigo arm vs the placebo arm, respectively, were nausea (36% vs 35%), diarrhea (25% vs 15%), vomiting (19% vs 14%), and peripheral edema (13% vs 10%). Grade 3 and 4 adverse events were reported in 57% of Xofigo-treated patients and 63% of placebo-treated patients. The most common hematologic laboratory abnormalities in the Xofigo arm (≥10%) vs the placebo arm, respectively, were anemia (93% vs 88%), lymphocytopenia (72% vs 53%), leukopenia (35% vs 10%), thrombocytopenia (31% vs 22%), and neutropenia (18% vs 5%)

Please see the full Prescribing Information for Xofigo (radium Ra 223 dichloride).

On February 11, 2025 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the fourth quarter and full year 2024 (Press release, Gilead Sciences, FEB 11, 2025, View Source [SID1234650170]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Gilead delivered another exceptionally strong full year and fourth quarter, with growth in our base business product sales of 8% for 2024 and 13% year-over-year for the fourth quarter," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "From this foundation of commercial strength, we are planning for the potential launch of lenacapavir for HIV PrEP in Summer 2025, with its unique opportunity to extend the reach of HIV prevention. This potential in HIV, along with our strong and diverse portfolio, and improved operational efficiencies, positions Gilead to deliver increasing patient impact and compelling shareholder returns in the years ahead."

Fourth Quarter 2024 Financial Results

•Total fourth quarter 2024 revenue increased 6% to $7.6 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease, partially offset by lower sales of Veklury (remdesivir).
•Diluted Earnings Per Share ("EPS") increased to $1.42 in the fourth quarter 2024 compared to $1.14 in the same period in 2023, primarily driven by lower costs of goods sold, higher product sales and lower acquired in-process research and development ("IPR&D") expenses, partially offset by higher operating expenses as well as unrealized losses on equity investments in 2024 compared to gains in 2023.
•Non-GAAP diluted EPS increased to $1.90 in the fourth quarter 2024 compared to $1.72 in the same period in 2023. The increase was primarily driven by higher product sales and lower acquired IPR&D expenses, partially offset by higher operating expenses.
•As of December 31, 2024, Gilead had $10.0 billion of cash, cash equivalents and marketable debt securities compared to $8.4 billion as of December 31, 2023.
•During the fourth quarter 2024, Gilead generated $3.0 billion in operating cash flow.
•During the fourth quarter 2024, Gilead issued senior unsecured notes in an aggregate principal amount of $3.5 billion, paid cash dividends of $973 million and utilized $350 million to repurchase common stock.
Fourth Quarter 2024 Product Sales
Total fourth quarter 2024 product sales increased 7% to $7.5 billion compared to the same period in 2023. Total product sales excluding Veklury increased 13% to $7.2 billion compared to the same period in 2023, primarily due to higher sales in HIV, as well as in Oncology and Liver Disease.
HIV product sales increased 16% to $5.5 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics.
•Biktarvy (bictegravir 50mg/emtricitabine ("FTC") 200mg/tenofovir alafenamide ("TAF") 25mg) sales increased 21% to $3.8 billion in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, favorable inventory dynamics and higher average realized price.

•Descovy (FTC 200mg/TAF 25mg) sales increased 21% to $616 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher demand, higher average realized price and favorable inventory dynamics.
The Liver Disease portfolio sales increased 4% to $719 million in the fourth quarter 2024 compared to the same period in 2023. This was primarily driven by the launch of Livdelzi (seladelpar) in primary biliary cholangitis ("PBC"), and increased demand in products for chronic hepatitis B virus ("HBV") and chronic hepatitis delta virus ("HDV"), partially offset by lower demand and average realized price in products for chronic hepatitis C virus ("HCV").
Veklury sales decreased 53% to $337 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by lower rates of COVID-19 related hospitalizations, particularly in the United States.
Cell Therapy product sales increased 5% to $488 million in the fourth quarter 2024 compared to the same period in 2023.
•Yescarta (axicabtagene ciloleucel) sales increased 6% to $390 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by higher average realized price and increased demand outside of the United States, partially offset by lower demand in the United States.
•Tecartus (brexucabtagene autoleucel) sales of $98 million in the fourth quarter 2024 were flat compared to the same period in 2023, reflecting increased demand outside of the United States, offset by lower demand in the United States.
Trodelvy (sacituzumab govitecan-hziy) sales increased 19% to $355 million in the fourth quarter 2024 compared to the same period in 2023, primarily driven by increased demand in all regions, as well as higher average realized price.
Fourth Quarter 2024 Product Gross Margin, Operating Expenses and Tax
•Product gross margin was 79.0% in the fourth quarter 2024 compared to 70.4% in the same period in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.7% in the fourth quarter 2024 compared to 86.1% in the same period in 2023.
•Research and development ("R&D") expenses were $1.6 billion in the fourth quarter 2024 compared to $1.4 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio and the impact of a prior year valuation adjustment to the MYR-related contingent consideration that did not repeat. Non-GAAP R&D expenses were $1.6 billion in the fourth quarter 2024 compared to $1.5 billion in the same period in 2023, primarily due to incremental investments and clinical activities across our portfolio.
•Acquired IPR&D expenses were $(11) million in the fourth quarter 2024, reflecting expenses related to the Terray Therapeutics, Inc. ("Terray") and Tubulis GmbH ("Tubulis") collaborations, offset by a favorable adjustment related to the CymaBay Therapeutics, Inc. ("CymaBay") acquisition.
•Selling, general and administrative ("SG&A") and non-GAAP SG&A expenses were $1.9 billion in the fourth quarter 2024 compared to $1.6 billion in the same period in 2023, primarily driven by a litigation accrual and higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV pre-exposure prophylaxis ("PrEP") as well as for Livdelzi.
•The effective tax rate ("ETR") was 17.8% in the fourth quarter 2024 compared to 14.3% in the same period in 2023, primarily due to prior year settlements with tax authorities and non-taxable unrealized gains and losses on equity investments. Non-GAAP ETR was 19.2% in the fourth quarter 2024 compared to 17.1% in the same period in 2023, primarily due to prior year settlements with tax authorities.

Full Year 2024 Financial Results
•Total full year 2024 revenue increased 6% to $28.8 billion compared to 2023, primarily due to higher sales in HIV, Oncology and Liver Disease, partially offset by lower sales of Veklury.
•Diluted EPS decreased to $0.38 in the full year 2024 compared to $4.50 in 2023. The decrease was primarily driven by a pre-tax IPR&D impairment charge of $4.2 billion, or $2.49 per share net of tax impact, related to assets acquired by Gilead from Immunomedics, Inc. ("Immunomedics") in 2020, and acquired IPR&D charges of $3.9 billion, or $3.14 per share, in the first quarter 2024 related to the acquisition of CymaBay, partially offset by higher product sales.
•Non-GAAP diluted EPS decreased to $4.62 in the full year 2024 compared to $6.72 in 2023. This was primarily driven by higher acquired IPR&D expenses related to the CymaBay acquisition and higher income tax expense, partially offset by higher product sales.
Full Year 2024 Product Sales
Total full year 2024 product sales increased 6% to $28.6 billion compared to 2023. Total product sales excluding Veklury increased 8% to $26.8 billion in the full year 2024 compared to 2023, primarily driven by higher sales in HIV, Oncology and Liver Disease.
HIV product sales increased 8% to $19.6 billion in the full year 2024 compared to 2023, primarily driven by higher demand, as well as the impact of higher average realized price.
•Biktarvy sales increased 13% to $13.4 billion in the full year 2024 compared to 2023, primarily driven by higher demand.
•Descovy sales increased 6% to $2.1 billion in the full year 2024 compared to 2023, primarily driven by higher demand, partially offset by lower average realized price.
The Liver Disease portfolio sales increased 9% to $3.0 billion in the full year 2024 compared to 2023. The increase was primarily due to higher demand across all liver diseases.
Veklury sales decreased 18% to $1.8 billion in the full year 2024 compared to 2023, primarily driven by lower rates of COVID-19 related hospitalizations.
Cell Therapy product sales increased 6% to $2.0 billion in the full year 2024 compared to 2023.
•Yescarta sales increased 5% to $1.6 billion in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States and higher average realized price, partially offset by lower demand in the United States.
•Tecartus sales increased 9% to $403 million in the full year 2024 compared to 2023, primarily driven by increased demand outside of the United States, partially offset by lower demand in the United States.
Trodelvy sales increased 24% to $1.3 billion in the full year 2024 compared to 2023, primarily driven by increased demand in all regions.
Full Year 2024 Product Gross Margin, Operating Expenses and Tax
•Product gross margin was 78.2% in the full year 2024 compared to 75.9% in 2023, primarily driven by prior year restructuring expenses related to changes in our manufacturing strategy. Non-GAAP product gross margin was 86.2% in the full year 2024 compared to 86.3% in 2023.
•R&D expenses were $5.9 billion in the full year 2024 compared to $5.7 billion in 2023, primarily driven by restructuring costs and integration expenses related to the CymaBay acquisition. Non-GAAP R&D expenses of $5.7 billion in the full year 2024 were flat compared to 2023.
•Acquired IPR&D expenses were $4.7 billion in the full year 2024 compared to $1.2 billion in 2023, primarily reflecting the acquisition of CymaBay.
•SG&A expenses of $6.1 billion in the full year 2024 were flat compared to 2023, reflecting higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi, integration costs related to the acquisition of CymaBay, and restructuring expenses, offset by lower expenses related to legal matters. Non-GAAP SG&A expenses were $5.9 billion in the full year 2024 compared to $6.1 billion in 2023, primarily driven by lower expenses related to legal matters, partially offset by higher sales and marketing spending, including launch preparation activities for lenacapavir for the investigational use of HIV PrEP as well as for Livdelzi.
•The ETR was 30.5% in the full year 2024 compared to 18.2% in 2023, primarily driven by the non-deductible acquired IPR&D charge for CymaBay and prior year decrease in tax reserves that did not repeat, partially offset by the tax impact of a legal entity restructuring and Immunomedics IPR&D impairment expense, as well as current year settlements with tax authorities and remeasurement of certain deferred tax liabilities. Non-GAAP ETR was 25.9% in the full year 2024 compared to 15.2% in 2023, primarily due to the non-deductible acquired IPR&D charge for CymaBay and a prior year decrease in tax reserves that did not repeat, partially offset by current year settlements with tax authorities.
Guidance and Outlook
For the full-year 2025, Gilead expects:
(in millions, except per share amounts)
February 11, 2025 Guidance
Low End High End
Product sales $ 28,200 $ 28,600
Product sales excluding Veklury $ 26,800 $ 27,200
Veklury $ 1,400 $ 1,400
Diluted EPS $ 5.95 $ 6.35
Non-GAAP diluted EPS $ 7.70 $ 8.10

Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2025 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 new HIV data at the International Congress on Drug Therapy in HIV Infection ("HIV Glasgow 2024"). This included full results from the Phase 3 PURPOSE 2 trial evaluating investigational twice-yearly lenacapavir for HIV prevention among cisgender men and gender-diverse people, with data published in the New England Journal of Medicine.
•Additionally at HIV Glasgow 2024, presented new HIV treatment research data from Biktarvy, as well as for investigational regimens with once-daily, once-weekly and twice-yearly dosing frequencies.
•Completed the New Drug Application submissions to U.S. Food and Drug Administration ("FDA"), as well as a marketing authorization application and an EU-Medicines for All application to the European Medicines Agency ("EMA"), for twice-yearly lenacapavir for HIV prevention.
•Lenacapavir named by Science Magazine as its 2024 "Breakthrough of the Year," based in part on the PURPOSE 1 and PURPOSE 2 trial results.
Oncology
•Our partner, Arcellx, Inc. ("Arcellx"), presented new data evaluating investigational anitocabtagene autoleucel ("anito-cel") in relapsed or refractory ("R/R") multiple myeloma at the American Society of Hematology (ASH) (Free ASH Whitepaper) 2024 Annual Meeting ("ASH 2024"). This included preliminary data from the registrational Phase 2 iMMagine-1 trial, as well as updated Phase 1 data.
•Presented new data at ASH (Free ASH Whitepaper) 2024 including long-term follow-up of Yescarta in R/R non-Hodgkin’s lymphoma and Tecartus in R/R mantle cell lymphoma, as well as real world data for Yescarta in R/R large B-cell lymphoma and Tecartus in B-cell precursor adult acute lymphoblastic leukemia.
•Granted Breakthrough Therapy Designation by FDA to Trodelvy for the treatment of adult patients with extensive-stage small cell lung cancer ("ES-SCLC") whose disease has progressed on or after platinum-based chemotherapy. The use of Trodelvy in ES-SCLC is investigational.
•Entered into a single-asset focused collaboration, license, and option agreement with Tubulis to develop an antibody-drug conjugate candidate for a solid tumor target using Tubulis’ Tubutecan and Alco5 platforms.
Inflammation
•Received a positive opinion from the EMA’s Committee for Medicinal Products for Human Use recommending seladelpar for the treatment of PBC in combination with ursodeoxycholic acid ("UDCA") in adults who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
•Received marketing authorization from the Medicines and Healthcare products Regulatory Agency in the UK for seladelpar for treatment of PBC, including pruritus, in adults in combination with UDCA who have an inadequate response to UDCA alone, or as monotherapy in those unable to tolerate UDCA.
•Presented new data evaluating seladelpar in PBC at the American Association for the Study of Liver Diseases’ The Liver Meeting. This included longer-term follow-up data from the ASSURE trial, as well as additional analyses from the RESPONSE trial.
•Announced a strategic partnership to develop and commercialize the pre-clinical oral STAT6 program of LEO Pharma A/S ("LEO Pharma") for the potential treatment of inflammatory diseases.
Corporate
•Appointed Dietmar Berger, MD, PhD, as Chief Medical Officer effective January 2025.
•Entered into a strategic research collaboration with Terray to discover and develop novel, small molecule therapies across multiple targets using Terray’s artificial intelligence tNOVA platform.
•Reached a final settlement agreement with the U.S. Department of Justice and the U.S. Department of Health and Human Services on patents that the government alleged covered Truvada (FTC 200mg/tenofovir disoproxil fumarate ("TDF") 300mg) and Descovy for HIV PrEP.

•Issued $3.5 billion aggregate principal amount of senior unsecured notes in a registered offering.
•The Board declared a quarterly dividend of $0.79 per share of common stock for the first quarter of 2025. The dividend is payable on March 28, 2025, to stockholders of record at the close of business on March 14, 2025. 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 View Source and will be archived on www.gilead.com for one year.

On February 11, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, an innovative, FDA-cleared delivery platform, reported the closing of its previously announced $12.1 million firm commitment underwritten public offering of common stock led by multiple fundamental healthcare institutional investors (Press release, Renovorx, FEB 11, 2025, View Source [SID1234650186]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are very excited to close this common stock-only financing led by multiple high-quality fundamental healthcare institutional investors who are new to our company, which we view as a major achievement," said Shaun Bagai, CEO of RenovoRx. "This financing strengthens our balance sheet as we progress towards the potential realization of important valuation inflection points planned for 2025, including the recording of our first RenovoCath sales revenue, completion of enrollment for our pivotal Phase III TIGeR-PaC clinical trial, and a second interim data readout from that trial. The support from our new institutional investors highlights their strong confidence in our patented Trans-Arterial Micro-Perfusion (TAMP) therapy platform and our clinical and commercial plans for our FDA-cleared RenovoCath delivery system. We strongly believe our technology has the potential to revolutionize cancer treatment by enabling precise delivery of therapeutic agents. We look forward to utilizing the proceeds of this offering to help make this potential a reality and drive value for our stockholders."

In the offering, which closed on February 10, 2025, RenovoRx sold 11,523,810 shares of its common stock at an offering price of $1.05 per share. The gross proceeds from the offering were approximately $12.1 million, with net proceeds of approximately $10.9 million after deducting underwriting discounts and commissions and offering expenses payable by RenovoRx. RenovoRx intends to use the net proceeds from the offering for working capital and general corporate purposes, including continued progress on its Phase III TIGeR-PaC study and the continued development and execution of commercial sales and marketing activities for RenovoCath as a standalone device.

Titan Partners Group, a division of American Capital Partners, acted as the sole bookrunner for the offering. Ellenoff Grossman & Schole LLP acted as legal counsel to RenovoRx, and Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. acted as legal counsel to Titan Partners Group.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy any of these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the applicable securities laws of such state or jurisdiction.