Intraabdominal Infections

Reports First-Quarter Diluted EPS of $0.72 on a GAAP Basis, a Decrease of 6.5 Percent; Adjusted Diluted EPS of $2.46, an Increase of 6.5 Percent; These Results Include an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Delivers First-Quarter Net Revenues of $13.343 Billion, an Increase of 8.4 Percent on a Reported Basis or 9.8 Percent on an Operational Basis First-Quarter Global Net Revenues from the Immunology Portfolio Were $6.264 Billion, an Increase of 16.6 Percent on a Reported Basis, or 18.1 Percent on an Operational Basis; Global Skyrizi Net Revenues Were $3.425 Billion; Global Rinvoq Net Revenues Were $1.718 Billion; Global Humira Net Revenues Were $1.121 Billion First-Quarter Global Net Revenues from the Neuroscience Portfolio Were $2.282 Billion, an Increase of 16.1 Percent on a Reported Basis, or 17.0 Percent on an Operational Basis; Global Vraylar Net Revenues Were $765 Million; Global Botox Therapeutic Net Revenues Were $866 Million; Combined Global Ubrelvy and Qulipta Net Revenues Were $433 Million First-Quarter Global Net Revenues from the Oncology Portfolio Were $1.633 Billion, an Increase of 5.8 Percent on a Reported Basis, or 7.5 Percent on an Operational Basis; Global Imbruvica Net Revenues Were $738 Million; Global Venclexta Net Revenues Were $665 Million; Global Elahere Net Revenues Were $179 Million First-Quarter Global Net Revenues from the Aesthetics Portfolio Were $1.102 Billion, a Decrease of 11.7 Percent on a Reported Basis, or 10.2 Percent on an Operational Basis; Global Botox Cosmetic Net Revenues Were $556 Million; Global Juvederm Net Revenues Were $231 Million Raises 2025 Adjusted Diluted EPS Guidance Range from $11.99 - $12.19 to $12.09 - $12.29, which Includes an Unfavorable Impact of $0.13 Per Share Related to Acquired IPR&D and Milestones Expense Incurred Year-To-Date Through the First Quarter 2025 NORTH CHICAGO, Ill., April 25, 2025 /PRNewswire/ -- AbbVie (NYSE:ABBV) announced financial results for the first quarter ended March 31, 2025. "AbbVie's first-quarter results were well ahead of our expectations and reflect an excellent start to the year," said Robert A. Michael, chief executive officer, AbbVie. "The fundamentals of our business are strong and we continue to bolster our outlook with pipeline advancements and strategic investments. Based on the progress we are making, AbbVie is well positioned for the long term." First -Quarter Results Worldwide net revenues were $13.343 billion, an increase of 8.4 percent on a reported basis, or 9.8 percent on an operational basis. Global net revenues from the immunology portfolio were $6.264 billion, an increase of 16.6 percent on a reported basis, or 18.1 percent on an operational basis. Global Skyrizi net revenues were $3.425 billion, an increase of 70.5 percent on a reported basis, or 72.0 percent on an operational basis. Global Rinvoq net revenues were $1.718 billion, an increase of 57.2 percent on a reported basis, or 59.7 percent on an operational basis. Global Humira net revenues were $1.121 billion, a decrease of 50.6 percent on a reported basis, or 49.5 percent on an operational basis. Global net revenues from the neuroscience portfolio were $2.282 billion, an increase of 16.1 percent on a reported basis, or 17.0 percent on an operational basis. Global Vraylar net revenues were $765 million, an increase of 10.3 percent. Global Botox Therapeutic net revenues were $866 million, an increase of 15.8 percent on a reported basis, or 17.0 percent on an operational basis. Global Ubrelvy net revenues were $240 million, an increase of 17.8 percent on a reported basis, or 18.0 percent on an operational basis. Global Qulipta net revenues were $193 million, an increase of 47.6 percent on a reported basis, or 48.3 percent on an operational basis. Global net revenues from the oncology portfolio were $1.633 billion, an increase of 5.8 percent on a reported basis, or 7.5 percent on an operational basis. Global Imbruvica net revenues were $738 million, a decrease of 11.9 percent. Global Venclexta net revenues were $665 million, an increase of 8.3 percent on a reported basis, or 12.3 percent on an operational basis. Global Elahere net revenues were $179 million. Global net revenues from the aesthetics portfolio were $1.102 billion, a decrease of 11.7 percent on a reported basis, or 10.2 percent on an operational basis. Global Botox Cosmetic net revenues were $556 million, a decrease of 12.3 percent on a reported basis, or 10.7 percent on an operational basis. Global Juvederm net revenues were $231 million, a decrease of 22.2 percent on a reported basis, or 20.0 percent on an operational basis. On a GAAP basis, gross margin in the first quarter was 70.0 percent. The adjusted gross margin was 84.1 percent. On a GAAP basis, selling, general and administrative (SG&A) expense was 24.7 percent of net revenues. The adjusted SG&A expense was 24.6 percent of net revenues. On a GAAP basis, research and development (R&D) expense was 15.5 percent of net revenues. The adjusted R&D expense was 15.4 percent of net revenues. Acquired IPR&D and milestones expense was 1.9 percent of net revenues. On a GAAP basis, operating margin in the first quarter was 28.0 percent. The adjusted operating margin was 42.3 percent. Net interest expense was $627 million. On a GAAP basis, the tax rate in the quarter was 22.4 percent. The adjusted tax rate was 14.2 percent. Diluted EPS in the first quarter was $0.72 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.46. These results include an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense. Recent Events AbbVie announced that its board of directors unanimously elected chief executive officer (CEO) Robert A. Michael to assume the additional position of chairman of the board of directors, effective July 1, 2025. He will succeed Richard A. Gonzalez, who formerly served as AbbVie's CEO and has been chairman since the Company's formation in 2013. AbbVie announced that the European Commission (EC) granted marketing authorization to Rinvoq (upadacitinib) for the treatment of giant cell arteritis (GCA) in adult patients. The approval was supported by data from the pivotal Phase 3 SELECT-GCA trial which demonstrated that Rinvoq achieved the primary endpoint of sustained remission and key secondary endpoints, including reduction in disease flares, lower cumulative steroid exposure and complete remission. This authorization marks the eighth approved indication for Rinvoq in the European Union (EU). At the Society of Gynecologic Oncology (SGO) Annual Meeting, AbbVie announced final data analysis from the Phase 3 MIRASOL trial evaluating the efficacy and safety of Elahere (mirvetuximab soravtansine-gynx) in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) compared to chemotherapy. At 30.5 months median follow-up, treatment with Elahere continued to show significant improvements in progression-free survival (PFS) and overall survival (OS) compared to investigator's choice (IC) chemotherapy. AbbVie and Xilio Therapeutics, a clinical-stage biotechnology company, announced a collaboration and option-to-license agreement that will combine AbbVie's oncology expertise with Xilio's proprietary tumor-activation technology to develop novel immunotherapies, including masked T-cell engagers, for people living with cancer. AbbVie announced that it submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of trenibotulinumtoxinE (BoNT/E) for the treatment of moderate to severe glabellar lines. TrenibotulinumtoxinE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration and short duration of effect of 2-3 weeks. If approved, trenibotulinumtoxinE will be the first neurotoxin of its kind available to patients. Allergan Aesthetics announced that the Allergan Medical Institute (AMI) will open three new state-of-the-art training centers in the U.S., expanding access to high-quality, tailored training for licensed aesthetics providers. The first training center is scheduled to open in Irvine, CA, with additional locations to follow in Atlanta, GA and Austin, TX. AbbVie and Gubra announced a license agreement to develop GUB014295 (ABBV-295), a potential best-in-class, long-acting amylin analog for the treatment of obesity. This partnership marks AbbVie's entrance into the obesity field and under the terms of the agreement, AbbVie will lead development and commercialization of GUB014295 globally. Prior to the close of the agreement, Gubra announced positive interim results from Part A of a Phase 1 multiple ascending dose (MAD) study, which showed that GUB014295 was well tolerated with body weight loss that was sustained in a manner consistent with data from a previously announced single ascending dose (SAD) study. AbbVie announced that the FDA approved Emblaveo (aztreonam and avibactam), as the first monobactam/β-lactamase inhibitor combination antibiotic therapy to treat complicated intra-abdominal infections, including those caused by Gram-negative bacteria. The approval of Emblaveo was supported by prior findings regarding the efficacy and safety of aztreonam for the treatment of complicated intra-abdominal infections as well as clinical trial results from the Phase 3 REVISIT study, which evaluated the efficacy, safety, and tolerability of Emblaveo for the treatment of serious infections due to Gram-negative bacteria. Full-Year 2025 Outlook AbbVie is raising its adjusted diluted EPS guidance for the full year 2025 from $11.99 - $12.19 to $12.09 - $12.29, which includes an unfavorable impact of $0.13 per share related to acquired IPR&D and milestones expense incurred year-to-date through the first quarter 2025. The company's 2025 adjusted diluted EPS guidance excludes any impact from acquired IPR&D and milestones that may be incurred beyond the first quarter of 2025, as both cannot be reliably forecasted. This guidance does not reflect the acquired IPR&D and milestones impact related to AbbVie and Gubra's licensing agreement to develop GUB014295, as that transaction closed after the first quarter of 2025. Additionally, this guidance is based on the existing trade environment and does not reflect any trade policy shifts, including pharmaceutical sector tariffs, that could impact AbbVie's business. About AbbVie AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, neuroscience, oncology, and eye care - and products and services across our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X (formerly Twitter), Facebook, Instagram, YouTube or LinkedIn. Conference Call AbbVie will host an investor conference call today at 8:00 a.m. Central Time to discuss our first-quarter performance. The call will be webcast through AbbVie's Investor Relations website at investors.abbvie.com. An archived edition of the call will be available after 11:00 a.m. Central Time. Non-GAAP Financial Results Financial results for 2025 and 2024 are presented on both a reported and a non-GAAP basis. Reported results were prepared in accordance with GAAP and include all revenue and expenses recognized during the period. Non-GAAP results adjust for certain non-cash items and for factors that are unusual or unpredictable, and exclude those costs, expenses, and other specified items presented in the reconciliation tables later in this release. AbbVie's management believes non-GAAP financial measures provide useful information to investors regarding AbbVie's results of operations and assist management, analysts, and investors in evaluating the performance of the business. Non-GAAP financial measures should be considered in addition to, and not as a substitute for, measures of financial performance prepared in accordance with GAAP. Forward-Looking Statements Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. SOURCE AbbVie WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

– The First Pivotal Phase 3 Trial to Demonstrate Superiority of a TROP-2 Antibody-Drug Conjugate, Trodelvy, Plus Keytruda Versus Standard of Care Keytruda plus Chemotherapy in 1L mTNBC – – Trodelvy Plus Keytruda Shows an Early Trend in Improvement for Overall Survival Versus Standard of Care in Patients with Previously Untreated PD-L1+ (CPS ≥10) mTNBC – FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ASCENT-04/KEYNOTE-D19 study, demonstrating that Trodelvy® (sacituzumab govitecan-hziy) plus Keytruda® (pembrolizumab) significantly improved progression-free survival (PFS) compared to Keytruda and chemotherapy in patients with inoperable (unresectable) locally advanced or metastatic triple-negative breast cancer (mTNBC) whose tumors express PD-L1 (CPS ≥ 10). The study met its primary endpoint, showing a statistically significant and clinically meaningful improvement in PFS. The safety profile of Trodelvy plus Keytruda in the ASCENT-04 study was consistent with the known safety profile of each agent. No new safety signals were identified with the combination. “These findings are the first to show the transformative potential of an antibody-drug conjugate combined with an immuno-oncology agent in early treatment lines of metastatic breast cancer,” said Dietmar Berger, MD, PhD, Chief Medical Officer, Gilead Sciences. “For patients with this difficult to treat type of breast cancer, these results potentially offer a new pathway that may redefine their treatment options.” “For patients with metastatic triple-negative breast cancer, there is a critical need for more effective treatment options,” said Dr. Sara Tolaney, MD, MPH, Dana-Farber Cancer Institute and primary investigator of the ASCENT-04 study. “These data suggest that the combination of sacituzumab govitecan-hziy and pembrolizumab may offer a new treatment approach—bringing together a potent antibody drug conjugate with immunotherapy to improve outcomes for patients.” Overall survival (OS) is a key secondary endpoint and was not mature at the time of the PFS primary analysis. However, in the ASCENT-04 study, there was an early trend in improvement for OS with Trodelvy plus Keytruda. Gilead will continue to monitor OS outcomes, with ongoing patient follow-up and further analyses planned. Detailed results from the study will be presented at a future medical meeting and discussed with regulatory authorities. The use of Trodelvy plus Keytruda in patients with previously untreated PD-L1+ metastatic TNBC is investigational, and the safety and efficacy of this use have not been established. The significant and meaningful improvement in PFS demonstrated in ASCENT-04 further reinforces the potential of Trodelvy plus Keytruda as a much-needed new treatment option for patients with previously untreated inoperable (unresectable) PD-L1+ locally advanced or mTNBC. Trodelvy is the only approved Trop-2-directed antibody-drug conjugate (ADC) that has demonstrated meaningful survival advantages in two different types of metastatic breast cancers: 2L+ mTNBC and pre-treated HR+/HER2- mBC. It is a Category 1 preferred treatment for both indications per the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology (NCCN Guidelinesi) and the only ADC with an ESMO Magnitude of Clinical Benefit Scale (MCBS) rating of 5 for mTNBC. Trodelvy also has an MCBS rating of 4 for women with HR+/HER2- mBC. With established healthcare professional experience, Trodelvy has shown consistent outcomes across clinical trials and real-world studies in 50,000+ patients across ~50 countries over ~5 years. It has now demonstrated improved outcomes in three Phase 3 breast cancer trials and is being studied in several ongoing clinical trials, aiming to extend survival across diverse tumor types and disease stages. Currently, Gilead has three ongoing Phase 3 studies investigating Trodelvy across HER2- (IHC 0, IHC 1+ or IHC 2+/ISH–) mBC, including the upcoming ASCENT-03 pivotal trial in 1L mTNBC patients who are not candidates for PD-L1 based therapy, the ASCENT-05 pivotal trial in patients with early-stage TNBC (eTNBC), and the ASCENT-07 pivotal trial in patients with HR+/HER2- mBC who have received endocrine therapy. Trodelvy is also being investigated in additional Phase 3 studies in other disease settings, including in lung and gynecological cancers. Gilead would like to thank the patients, families, investigators and advocates who have contributed and continue to contribute to this important research. We remain committed to advancing care to address the unmet needs for the breast cancer community. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About Triple-Negative Breast Cancer with PD-L1+ Tumors TNBC is the most aggressive type of breast cancer and has historically been difficult to treat, accounting for approximately 15% of all breast cancers. TNBC is diagnosed more frequently in younger and premenopausal women and is more prevalent in Black and Hispanic women. TNBC cells do not have estrogen and progesterone receptors and have limited HER2. Due to the nature of TNBC, treatment options are extremely limited compared with other breast cancer types. TNBC has a higher chance of recurrence and metastases than other breast cancer types. The average time to metastatic recurrence for TNBC is approximately 2.6 years compared with 5 years for other breast cancers, and the relative five-year survival rate is much lower. Among women with mTNBC, the five-year survival rate is 12%, compared with 28% for those with other types of mBC. Despite progress in treatment, first-line mTNBC has seen limited new approvals in recent years for tumors that express PD-L1+, and additional options are urgently needed. Despite recent advances, over 50% of patients do not receive treatment beyond first-line, reinforcing the urgent need for new options to help improve patient outcomes. Breast cancers expressing PD-L1 are overall more aggressive and associated with reduced survival time. About the ASCENT-04/KEYNOTE-D19 Study In 2021, Gilead entered a collaboration with Merck & Co. to investigate sacituzumab govitecan in combination with pembrolizumab in the Phase 3 trial, ASCENT-04/KEYNOTE-D19. The ASCENT-04/KEYNOTE-D19 study is a global, open-label, randomized Phase 3 trial evaluating the efficacy and safety of sacituzumab govitecan in combination with pembrolizumab compared with treatment of chemotherapy plus pembrolizumab in patients with previously untreated, inoperable locally advanced or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1. The study enrolled 443 patients across multiple study sites. Patients were randomized in a 1:1 ratio to receive either sacituzumab govitecan (10 mg/kg intravenously on Days 1 and 8 of a 21-day cycle) plus pembrolizumab (200 mg intravenously on Day 1 of a 21-day cycle) or chemotherapy plus pembrolizumab. The chemotherapy regimen included gemcitabine plus carboplatin, paclitaxel, or nab-paclitaxel. Treatment continued until blinded independent central review (BICR)-verified disease progression or unacceptable toxicity. Patients randomized to chemotherapy were allowed to crossover and receive sacituzumab govitecan upon disease progression. The primary endpoint of the study is progression-free survival (PFS) as determined by BICR using RECIST v1.1. Secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), time to onset of response (TTR), patient-reported outcomes (PROs), and safety. More information about ASCENT-04/KEYNOTE-D19 is available at ClinicalTrials.gov: NCT05382286. About Trodelvy Trodelvy® (sacituzumab govitecan-hziy) is a first-in-class Trop-2-directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and lung cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the tumor microenvironment through a bystander effect. Trodelvy is currently approved in more than 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) patients and in more than 40 countries for certain patients with pre-treated HR+/HER2- metastatic breast cancer. Trodelvy is being investigated for use in other TNBC and HR+/HER2- breast cancer populations, as well as a range of tumor types where Trop-2 is highly expressed, including extensive-stage small cell lung cancer and first-line metastatic non-small cell lung cancer where Trodelvy has shown clinical activity through the TROPiCS-03 proof-of-concept study and the EVOKE-02 proof-of-concept study, respectively. INDICATIONS TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with: Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. Unresectable locally advanced or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative (IHC 0, IHC 1+ or IHC 2+/ISH–) breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting. IMPORTANT SAFETY INFORMATION BOXED WARNING: NEUTROPENIA AND DIARRHEA TRODELVY can cause severe, life-threatening, or fatal neutropenia. Withhold TRODELVY for absolute neutrophil count below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Primary prophylaxis with G-CSF is recommended for all patients at increased risk of febrile neutropenia. Initiate anti-infective treatment in patients with febrile neutropenia without delay. TRODELVY can cause severe diarrhea. Monitor patients with diarrhea and give fluid and electrolytes as needed. At the onset of diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses. CONTRAINDICATIONS Severe hypersensitivity reaction to TRODELVY. WARNINGS AND PRECAUTIONS Neutropenia: Severe, life-threatening, or fatal neutropenia can occur as early as the first cycle of treatment and may require dose modification. Neutropenia occurred in 64% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 49% of patients. Febrile neutropenia occurred in 6%. Neutropenic colitis occurred in 1.4%. Primary prophylaxis with G-CSF is recommended starting in the first cycle of treatment in all patients at increased risk of febrile neutropenia, including older patients, patients with previous neutropenia, poor performance status, organ dysfunction, or multiple comorbidities. Monitor absolute neutrophil count (ANC) during treatment. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Treat neutropenia with G-CSF and administer prophylaxis in subsequent cycles as clinically indicated or indicated in Table 2 of USPI. Diarrhea: Diarrhea occurred in 64% of all patients treated with TRODELVY. Grade 3-4 diarrhea occurred in 11% of patients. One patient had intestinal perforation following diarrhea. Diarrhea that led to dehydration and subsequent acute kidney injury occurred in 0.7% of all patients. Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to ≤ Grade 1. At onset, evaluate for infectious causes and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g., fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive cholinergic response to treatment can receive appropriate premedication (e.g., atropine) for subsequent treatments. Hypersensitivity and Infusion-Related Reactions: TRODELVY can cause serious hypersensitivity reactions including life-threatening anaphylactic reactions. Severe signs and symptoms included cardiac arrest, hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24 hours of dosing occurred in 35% of patients. Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.2%. The incidence of anaphylactic reactions was 0.2%. Pre-infusion medication is recommended. Have medications and emergency equipment to treat such reactions available for immediate use. Observe patients closely for hypersensitivity and infusion-related reactions during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for Grade 4 infusion-related reactions. Nausea and Vomiting: TRODELVY is emetogenic and can cause severe nausea and vomiting.Nausea occurred in 64% of all patients treated with TRODELVY and Grade 3-4 nausea occurred in 3% of these patients. Vomiting occurred in 35% of patients and Grade 3-4 vomiting occurred in 2% of these patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of chemotherapy-induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to Grade ≤ 1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting. Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 58% in patients homozygous for the UGT1A1*28, 49% in patients heterozygous for the UGT1A1*28 allele, and 43% in patients homozygous for the wild-type allele. The incidence of Grade 3-4 anemia was 21% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and 9% in patients homozygous for the wild-type allele. Closely monitor patients with known reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on clinical assessment of the onset, duration and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse reactions, which may indicate reduced UGT1A1 function. Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with TRODELVY and for 3 months after the last dose. ADVERSE REACTIONS In the pooled safety population, the most common (≥ 25%) adverse reactions including laboratory abnormalities were decreased leukocyte count (84%), decreased neutrophil count (75%), decreased hemoglobin (69%), diarrhea (64%), nausea (64%), decreased lymphocyte count (63%), fatigue (51%), alopecia (45%), constipation (37%), increased glucose (37%), decreased albumin (35%), vomiting (35%), decreased appetite (30%), decreased creatinine clearance (28%), increased alkaline phosphatase (28%), decreased magnesium (27%), decreased potassium (26%), and decreased sodium (26%). In the ASCENT study (locally advanced or metastatic triple-negative breast cancer), the most common adverse reactions (incidence ≥25%) were fatigue, diarrhea, nausea, alopecia, constipation, vomiting, abdominal pain, and decreased appetite. The most frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%), diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and 5% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the ASCENT study were reduced neutrophils, leukocytes, and lymphocytes. In the TROPiCS-02 study (locally advanced or metastatic HR-positive, HER2-negative breast cancer), the most common adverse reactions (incidence ≥25%) were diarrhea, fatigue, nausea, alopecia, and constipation. The most frequent serious adverse reactions (SAR) (>1%) were diarrhea (5%), febrile neutropenia (4%), neutropenia (3%), abdominal pain, colitis, neutropenic colitis, pneumonia, and vomiting (each 2%). SAR were reported in 28% of patients, and 6% discontinued therapy due to adverse reactions. The most common Grade 3-4 lab abnormalities (incidence ≥25%) in the TROPiCS-02 study were reduced neutrophils and leukocytes. DRUG INTERACTIONS UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with TRODELVY. UGT1A1 Inducers: Exposure to SN-38 may be reduced in patients concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1 inducers with TRODELVY. Please see full Prescribing Information, including BOXED WARNING. 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 This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving Trodelvy (such as ASCENT-03, ASCENT-04 and ASCENT-05); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation; the possibility that Gilead may make a strategic decision to discontinue development of these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties 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 and disclaims any intent to update any such forward-looking statements. U.S. Prescribing Information for Trodelvy, including BOXED WARNING, is available at www.gilead.com. Trodelvy, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies. For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter ( @Gilead Sciences ) and LinkedIn, or contact Gilead Public Affairs at public_affairs@gilead.com, 1-800-GILEAD-5 or 1-650-574-3000. i NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. Ashleigh Koss, Media public_affairs@gilead.com Jacquie Ross, Investors investor_relations@gilead.com

SHANGHAI, March 25, 2025 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the discovery, clinical development, manufacturing and commercialization of innovative medicines and vaccines, today announced its financial results for the full year ended December 31, 2024, along with a corporate update. "In 2024, Everest continued to strength the execution of our 'Dual-Engine' strategy, having evolved from a license-in model to a balanced approach that combines in-house discovery with global partnerships and in-licensing, with a focus on high-value programs and the development of first-in-class or best-in-class assets," commented Rogers Yongqing Luo, CEO of Everest Medicines. "Our total revenue reached RMB706.7 million, representing a 461% year-over-year increase and exceeding our revenue guidance of RMB700 million. Operating expenses as a percentage of revenue decreased significantly by 562%. Notably, our non-IFRS net loss narrowed by 25%, and our gross margin, excluding non-cash items, reached 83%. We ended the year with a strong cash balance of RMB1.6 billion. Importantly, we achieved commercial-level profitability for the full year of 2024. The highlight of our commercial execution in 2024 was the successful launch of NEFECON® in mainland China in May, marking the beginning of a new era in the treatment of IgA nephropathy (IgAN). The product generated RMB353.4 million in revenue for the year, representing a year-over-year increase of 1,581%. NEFECON® was also included in China's National Reimbursement Drug List (NRDL), helping to address a significant unmet medical need among Chinese patients. In addition, it received regulatory approvals in Singapore, Hong Kong SAR, Taiwan region, and South Korea during 2024, expanding its regional footprint in Asia. We also delivered robust growth with XERAVA® (eravacycline), a first-in-class fluorocycline antibiotic, which generated RMB352.8 million in revenue in 2024, representing a 256% year-on-year increase. This strong performance was driven by its differentiated clinical profile and rising market demand. In our autoimmune portfolio, we achieved significant progress with VELSIPITY® (etrasimod), which received regulatory approvals in Macau SAR and Singapore in April 2024. The product was subsequently commercially launched in December in Guangdong province under the 'Hong Kong and Macau Medicine and Equipment Connect' policy. In parallel, New Drug Applications (NDAs) for VELSIPITY® have been officially accepted in both mainland China and Hong Kong in December 2024." "We continued to advance our pipeline of assets with global rights, focusing on creating value in high-potential therapeutic areas. EVER001, a covalent reversible BTK inhibitor, delivered positive results from the preliminary analysis of our Phase 1b/2a trial and is progressing steadily through global development. We also achieved a major milestone by advancing our mRNA platform from early-stage research into global clinical development, underscoring both our innovation capabilities and the strategic potential of our AI-powered mRNA technology. EVM16, our personalized therapeutic mRNA cancer vaccine, completed first patient dosing in an investigator-initiated clinical trial (IIT) in March 2025. EVM14, our off-the-shelf tumor-associated antigen (TAA) vaccine, received Investigational New Drug (IND) approval from the U.S. FDA, and we plan to submit an IND application to China's NMPA in the first half of this year. The in vivo CAR-T program is expected to achieve preclinical candidate milestone later this year. These programs are supported by our commercial-scale, GMP-compliant manufacturing facility in Jiashan, Zhejiang, which provides integrated R&D, production, and commercialization capabilities across mRNA and other pipeline platforms. In 2025, we will continue to enhance our commercial excellence and advance our first-in-class and best-in-class assets with global rights to maximize synergies. A key priority will be accelerating the sales of NEFECON®, leveraging its unique position as the only approved IgAN therapy in China and successfully included in the NRDL. With global rights to EVER001, we will actively explore partnership opportunities outside of China to leverage international expertise and optimize commercial value, while further enhancing Everest's global visibility and presence. Our 'Dual-Engine' strategy has entered a new chapter. Under the Board's guidance, Everest will leverage its established efficient commercial platform to solidify our position in key therapeutic areas, advance innovation on our mRNA platform, and strive to become a leading biopharma in the Asia-Pacific region by 2030—delivering greater value for shareholders and breakthrough therapies for patients worldwide." Luo concluded. Recent Key Product Highlights and Anticipated Milestones RENAL PRODUCTS PORTFOLIO Nefecon® 2024 - In March 2024, the Company's partner Calliditas Therapeutics AB ("Calliditas") (which was acquired by Asahi Kasei Corporation in September 2024 ) announced the U.S. FDA has granted an Orphan Drug exclusivity period of seven years for NEFECON®, expiring in December 2030 based on Calliditas obtaining full approval for this drug product in December 2023. - In March 2024, the Singapore Health Sciences Authority ("HSA") approved NEFEGAN®, known in other Everest territories as NEFECON®, for the treatment of primary IgAN in adults at risk of disease progression. Singapore marks the third region in Everest territories that received NDA approval after Macau and mainland China. - In April 2024, Calliditas published additional sub-analyses of NEFECON®'s Phase 3 NefIgArd study. One of the sub-analyses showed that during the 2-year period (9 months of treatment with NEFECON®, followed by a 15-month observation period after discontinuation), significant benefits in estimated glomerular filtration rate ("eGFR") were observed regardless of baseline UPCR levels (<0.8 g/g or ≥0.8 g/g). This study also showed that patients with UPCR <0.8 g/g who received NEFECON® achieved an eGFR slope of -0.25 mL/min/1.73 m3 per year, supporting the treatment target of <1 ml/min/1.73 m3 per year with the objective to avoid kidney failure in their lifetime. Another sub-analyses demonstrated that, irrespective of baseline UPCR levels and use of rescue medication, time to confirmed 30% eGFR reduction or kidney failure was significantly delayed. - In April 2024, Calliditas announced that the global open-label extension (OLE) study to the Phase 3 NefIgArd study showed a treatment response consistent with the NefIgArd study for the endpoints of urine protein to creatinine ratio ("UPCR") and eGFRat 9 months in all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. The safety data after 9 months of treatment or retreatment with Nefecon® in patients who completed the NefIgArd study were consistent with previously reported safety data. - In May 2024, the Hong Kong Department of Health had approved NEFECON® for the treatment of primary IgAN in adults at risk of disease progression. Hong Kong marks the fourth region in Everest territories where Nefecon® has received NDA approval after Singapore, Macau and mainland China. - In May 2024, Everest announced the successful launch of NEFECON® in mainland China, which has the highest prevalence of primary glomerular diseases in the world. The commercialization of NEFECON® in the Chinese market represents a significant milestone for Everest and a breakthrough for IgAN patients in China. The first prescription of NEFECON® was issued through an internet hospital, enhancing speed and convenience of delivering medication to patients and improving accessibility to the treatment. - In June 2024, Calliditas announced an additional efficacy analysis of NEFECON® in IgAN at the 61st European Renal Association Congress. An anchored matching-adjusted indirect comparison (MAIC) was performed to estimate the relative effect of NEFECON® or sparsentan on the absolute eGFR change from baseline at 9, 12, and 24 months, with common comparators of optimized renin-angiotensin system inhibition for NefIgArd and irbesartan from the phase 3 PROTECT study. Using patient-level data from NefIgArd and trial-level data from PROTECT, the study demonstrated that treatment with NEFECON® 16 mg/day for 9 months was associated with greater eGFR benefit compared with continuous treatment with sparsentan 400 mg/day over 2 years. - In July 2024, China's NMPA accepted the submission of a supplemental New Drug Application seeking full approval of NEFECON® based on the complete clinical data from the global Phase 3 NeflgArd study. - In September 2024, NEFECON® was included in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline notes that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for IgAN patients who are at risk of progressive kidney function loss. - In October 2024, the Taiwan Food and Drug Administration approved NEFECON® indicated "to reduce the loss of kidney function in adult patients with primary IgAN who are at risk for disease progression". Taiwan was the fifth region in Everest Medicines' authorized area to approve NEFECON® after Macau, Mainland China, Singapore, and Hong Kong. - In October 2024, "Kidney 360" magazine published the complete two-year subpopulation data from Chinese patients in the Phase 3 NefIgArd clinical trial of NEFECON® under the title "Efficacy and Safety of Nefecon in Patients with Immunoglobulin A Nephropathy from Mainland China: 2-Year NefIgArd Trial Results". The article states that during the 2-year treatment and observation period, the Chinese subpopulation data showed improvements in kidney protection, proteinuria reduction, and microhematuria that were numerically greater than the outcomes of global population. - In October 2024, additional analyses of the NefIgArd study for NEFECON® were presented at the 2024 American Society of Nephrology Kidney Week (ASN Kidney Week 2024). One of the analyses showed that the ability of NEFECON® to specifically modulate pathogenic Gd-IgA1 production in the GALT while leaving systemic IgA responses and total IgA and IgG levels unchanged, supports its use as a generally well tolerated, targeted, locally-acting treatment option for IgAN. Another analysis demonstrated that real-world use of NEFECON® was well-tolerated and can reduce loss of kidney function in patients who receive ≥9 months of treatment. - In November 2024, NEFECON® received full approval from the Ministry of Food and Drug Safety ("MFDS") in South Korea, indicated for the treatment of adults with primary IgAN with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g). - In November 2024, NEFECON® was included in NRDL in mainland China which takes effect on January 1st, 2025. NEFECON®'s inclusion in the NRDL acknowledges its significant clinical value in improving patient care and with approximately 5 million IgAN patients in China and over 100,000 newly diagnosed patients annually, there is a significant unmet clinical demand in the country. - In December 2024, the first prescription for NEFECON® was issued at Hong Kong Gleneagles Hospital, marking a new era for the targeted treatment of IgAN in the region. It represents the third commercial launch of NEFECON® in the year, following its launch in Mainland China and Singapore. 2025 - On January 1, 2025, with the official implementation of the latest update of NRDL, NRDL pricing now applies to NEFECON® which will benefit more IgAN patients. NEFECON® is the only approved treatment for primary IgAN in adults at risk of disease progression in China. - In March 2025, the HSA has granted full approval of NEFEGAN® indicated "to reduce the loss of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at risk for disease progression with a urine protein excretion ≥1.0 g/day (or urine protein-to-creatinine ratio ≥0.8 g/g)". - We expect to commercially launch NEFECON® in Taiwan region and South Korea in 2025. - We expect to receive NEFECON® full approval from NMPA in 2025. - We expect inclusion of NEFECON® in the KDIGO 2025 guidelines as well as in the first Chinese guideline for IgAN in 2025.® EVER001 is a next-generation covalent reversible Bruton's tyrosine kinase (BTK) inhibitor with potentially best-in-class characteristics for the treatment of autoimmune renal diseases. Compared to covalent irreversible BTK inhibitors, EVER001 offers improved selectivity while maintaining high potency, thereby potentially avoiding many of the side effects associated with earlier-generation BTK inhibitors. Everest Medicines holds global rights to EVER001 for the treatment of renal diseases. 2024 - In December 2024, Everest announced positive results in the ongoing Phase 1b/2a clinical trial for the treatment of pMN with EVER001. In an analysis of the data available as of September 13th, 2024, we observed that of the patients in the low-dose cohort who have completed 36 weeks of treatment, 9 out of 11 (81.8%) achieved overall clinical remission and 10 out of 11 (91%) achieved immunological complete remission (ICR). In the high dose cohort, 6 out of 7 (85.7%) patients achieved overall clinical remission and all patients achieved ICR by week 24. EVER001 was generally safe and well tolerated. No clinically significant adverse events typically associated with earlier-generation BTK inhibitors, such as bleeding, arrhythmia, severe infection, leukopenia, thrombocytopenia, or severe liver function impairment, were reported. 2025 - We expect to report one-year follow up data of the Phase 1b/2a clinical trial in 2025. INFECTIOUS DISEASE PORTFOLIO XERAVA® (eravacycline) 2024 - In January 2024, eravacycline's clinical breakpoint was officially approved by the Expert Committee of the National Health Commission on Antimicrobial Susceptibility Testing and Standard Research (ChinaCAST) for clinical use in China. - In November 2024, data on eravacycline (XERAVA®), were presented in Los Angeles, California at IDWeek 2024. The first study evaluated the in vitro antimicrobial activity of eravacycline against Carbapenem-resistant Acinetobacter baumannii (CRAB). Using the recently approved, ChinaCAST breakpoint of 1 µg/mL the results showed a high susceptibility rate of eravacycline against CRAB. The second study evaluated the in vitro activity of eravacycline against 23,127 global clinical isolates of major Gram-positive and Gram-negative bacteria, including drug-resistant strains collected from various regions such as Asia, Europe, and North America from 2018 to 2022. Since its approval in 2018, eravacycline has consistently maintained a high level of susceptibility against clinically relevant pathogens across diverse geographic regions and infection sites which supports eravacycline's use in treating complicated intra-abdominal infections caused by both Gram-negative and Gram-positive bacteria. - In November 2024, in a real-world clinical evaluation led by the National Health Commission's Expert Committee on Clinical Use of Antimicrobials and Evaluation of Antimicrobial Resistance, the final report showed that the overall efficacy rate of eravacycline treatment for 3 days was 91.1%, and the overall treatment efficacy rate at the end of treatment was 90.1%. Cefepime-taniborbactam is an investigational agent that is a combination of cefepime, a fourth-generation cephalosporin, and the novel beta-lactamase inhibitor (BLI), taniborbactam, that exhibits broad coverage of both serine- and metallo-beta-lactamases. In combination with cefepime, taniborbactam is under development as a new treatment option for patients with serious bacterial infections caused by difficult-to-treat drug resistant gram-negative pathogens, including carbapenem-resistant Enterobacterales (CRE) and carbapenem-resistant or multidrug-resistant Pseudomonas aeruginosa (CRPA/MDR-PA). 2024 - In February 2024, The New England Journal of Medicine ("NEJM") published the results of the CERTAIN-1 Phase 3 clinical study of the investigational agent cefepime-taniborbactam for the treatment of adult patients with complicated urinary tract infections ("cUTI"), including acute pyelonephritis. The results showed that cefepime-taniborbactam was superior to meropenem for the treatment of complicated UTI that included acute pyelonephritis, with a similar safety profile to meropenem. 2025 - We expect to submit an NDA for cefepime-taniborbactam in cUTI to China NMPA in 2025. AUTOIMMUNE DISEASE PORTFOLIO VELSIPITY® (etrasimod) 2024 - In February 2024, our licensing partner Pfizer Inc. announced that the European Commission ("EC") granted marketing authorization for VELSIPITY® in the European Union to treat patients 16 years of age and older with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional therapy, or a biological agent. - In March 2024, the Pharmaceutical Administration Bureau of the Macau Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. In April, the bureau approved the NDA, marking the first approval of VELSIPITY® in Everest territories. - In July 2024, Everest announced positive topline data results of the maintenance period from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia for the treatment of subjects with moderately-to-severely active UC. The data of maintenance treatment confirmed that, after 40 weeks of treatment of 2mg once-daily VELSIPITY or placebo, VELSIPITY® demonstrated significant clinical and statistical improvements over placebo in the primary and all key secondary endpoints (p<0.0001), and other secondary endpoints (including mucosal healing and endoscopic normalization, both p<0.0001). The safety profile of VELSIPITY® was consistent with previous studies, with no new safety signals observed. - In October 2024, Everest announced that, through the "Hong Kong and Macau Medicine and Equipment Connect" policy, VELSIPITY® was officially been approved for patients with moderately to severely active UC by the Guangdong Provincial Medical Products Administration and the first prescription for VELSIPITY® was written at Foshan Fosun Chancheng Hospital in Guangdong in December. VELSIPITY® is now Everest's third commercialized product. - In November 2024, the full induction period data results from a multi-center Phase 3 clinical trial of VELSIPITY® in Asia on the treatment of moderately to severely active UC with etrasimod was presented in an oral presentation at the 32nd United European Gastroenterology Week (UEGW 2024). The induction period results showed that all primary and key secondary efficacy endpoints in the etrasimod treatment group achieved statistically significant and clinically meaningful improvements compared to the placebo group. The treatment differences in clinical remission, endoscopic improvement, and clinical response rates were 20.4%, 28.6%, and 32.0%, respectively (all P-values <0.0001). Patients treated with etrasimod achieved clinically meaningful and statistically significant improvements in mucosal healing (P<0.0001) and endoscopic normalization (P=0.0003). - In December 2024, the Department of Health of the Government of the Hong Kong Special Administrative Region, China, accepted Everest's NDA for VELSIPITY® for the treatment of adult patients with moderately to severely active UC. - In December 2024, the first prescription of VELSIPITY® in Macau was issued at Kiang Wu Hospital and VELSIPITY® was included in the Catalog of Pharmaceutical and Medical Devices Imported from Hong Kong and Macau for the Nine Municipalities in Guangdong Province within the Guangdong-Hong Kong-Macau Greater Bay Area, published by the Guangdong Provincial Medical Products Administration and Health Commission of Guangdong Province. - In December 2024, the NMPA of China accepted the NDA for VELSIPITY® for the treatment of patients with moderately to severely active UC. We expect to receive NDA approval in 2026. 2025 - In February 2025, Everest announced the presentation of maintenance data from its multi-center Phase 3 clinical trial of etrasimod in Asia at the 20th European Crohn's and Colitis Organization Congress (ECCO 2025). The results demonstrated that treatment with etrasimod 2 mg resulted in a clinically meaningful and statistically significant improvement in the primary and all secondary endpoints at the end of maintenance period. A statistically significant greater proportion of etrasimodtreated patients achieved clinical remission at Week 40 compared with placebo. A statistically significant greater proportion of etrasimod-treated patients achieved endoscopic improvement and clinical response at week 40 compared with placebo. Other secondary endpoints of mucosal healing, endoscopic normalization, and histological remission also significantly favored patients treated with etrasimod compared with placebo. Notably, mucosal healing as measured by a central read endoscopic subscore ≤1 (excluding friability) with a Geboes Index score <2.0, was achieved in 51.9% of the etrasimod treated patients compared to 8.8% in the placebo group (2-sided p-value <0.0001). The safety profile of etrasimod during the maintenance period was consistent with previous studies, with no new safety findings observed. - In March 2025, Everest announced the launch of a construction project for etrasimod's local production at Jiashan factory. The project is expected to achieve an annual production capacity of 50 million tablets upon full operation. The planned supply regions include mainland China, Hong Kong, Macau, Taiwan, South Korea, and Singapore, covering Everest's licensing regions in Asia. - We expect to receive VELSIPITY® NDA approval in UC in Hong Kong in 2025. - We expect to submit NDA for VELSIPITY® in UC in Taiwan region and South Korea in 2025. - We will continue to expand VELSIPITY®'s accessibility in the Greater Bay area through the "Hong Kong and Macau Medicine and Equipment Connect" policy in 2025. Zetomipzomib is a novel, first-in-class, selective immunoproteasome inhibitor currently being evaluated for immune- mediated disorders. It was licensed from Kezar Life Sciences in 2023. Everest and Kezar collaborate on the development of zetomipzomib in autoimmune diseases such as autoimmune hepatitis. - In February 2024, Everest announced that the Center for Drug Evaluation ("CDE") of China's NMPA approved Kezar's IND application for initiation of the Phase 2b PALIZADE trial in China of zetomipzomib in patients with lupus nephritis ("LN"). - In July 2024, Everest announced that the first patient had been dosed in China with zetomipzomib in the global Phase 2b PALIZADE trial for the treatment of active LN. - In September 2024, PALIZADE was placed on clinical hold following the recommendation of the Independent Data Monitoring Committee. In October, Kezar made the strategic decision to terminate the PALIZADE trial and focus clinical development efforts on zetomipzomib in autoimmune hepatitis (AIH). - Zetomipzomib is currently being tested in PORTOLA, a placebo-controlled, randomized, double-blind Phase 2a clinical trial evaluating the efficacy and safety of the molecule in patients with AIH. AIH is a rare chronic disease in which the immune system attacks the liver and causes inflammation and tissue damage, severely impacting patients' physical health and quality of life. The study has completed enrollment of 24 patients, and Kezar expects to report topline results in 1H 2025. mRNA PLATFORM Everest has built end-to-end capabilities across its proprietary mRNA platform. Our R&D team is developing multiple mRNA-based therapeutic products including personalized cancer vaccines, tumor-associated antigen vaccines, immunomodulatory cancer vaccines, in vivo CAR-T program, as well as next generation lipid nanoparticle ("LNP") delivery systems to enhance cell-mediated immune response. Our mRNA manufacturing facility in Jiashan, Zhejiang Province in China is designed to comply with global good manufacturing practice ("GMP") standards and is able to produce at clinical- and commercial-scale. Everest owns full global intellectual property rights to its mRNA therapeutic programs. In 2024, the Company advanced its self-developed mRNA pipeline products, the first of which is EVM16, a novel personalized therapeutic mRNA cancer vaccine independently developed by Everest. It contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens. This platform will be an important part of our discovery efforts going forward. 2024 - In Feb. 2024, Everest announced the termination of the collaboration and license agreements with Providence Therapeutics Holdings Inc. Everest continues to develop its own therapeutic vaccine products utilizing the mRNA platform. - In August 2024, Everest announced the launch of an IIT for a personalized mRNA cancer vaccine, EVM16, under the study EVM16CX01, at the Peking University Cancer Hospital and Fudan University's Cancer Hospital. This trial is designed to assess the safety, tolerability, immunogenicity, and preliminary efficacy of EVM16 injection as a monotherapy and in combination with PD-1 antibody for patients with advanced or recurrent solid tumors. EVM16CX01 is the first-in-human ("FIH") trial for EVM16. 2025 - In March 2025, Everest announced that the first patient has been dosed with the Company's internally developed personalized mRNA cancer vaccine EVM16 at Peking University Cancer Hospital in the investigator-initiated clinical trial (IIT) EVM16CX01. - In March 2025, the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for EVM14, a TAA vaccine. EVM14 is Everest's first internally developed mRNA therapeutic vaccine to receive FDA IND approval, marking a significant milestone in the Company's efforts to develop innovative mRNA therapeutics in oncology. - We expect to submit IND application for EVM14 in China in 2025. PRODUCT PIPELINE Everest has built a strong product pipeline across renal, anti-infective, and autoimmune diseases that are all potentially first-in-class treatment or best-in-class assets. These programs encompass short-term, mid-term and long-term opportunities which are collectively expected to generate significant revenue growth for the Company and create value for its shareholders. Pipeline Outlook 2025 promises to be a year of important data readouts and significant advancement in our best-in-class programs which carry global rights. In 2024 we were pleased to report positive data from a preliminary analysis of a Phase 1b/2a clinical trial of EVER001, a novel BTK Inhibitor for the treatment of primary membranous nephropathy. We expect to advance this trial further in 2025 and plan to report one-year follow-up data in the second half of 2025. Among our self-developed programs, the first patients have been dosed in our IIT for personalized cancer vaccine and preliminary data on safety and immunogenicity are expected this year. In parallel, we have received FDA's IND approval for EVM14, our off-the-shelf TAA cancer vaccine. We also plan to submit IND application to China's NMPA for EVM14 in the first half of this year. It marks the first U.S. IND submission and approval for Everest, and the first IND applications for Everest's self-developed pipeline. With respect to our late-stage programs, we plan to submit the NDA for cefepime-taniborbactam to the NMPA in mainland China for the treatment of cUTI in 2025. We will also submit NDAs for VELSIPITY® in South Korea and Taiwan and expect to receive NDA approval for this product in Hong Kong in the second half of the year. Commercialization Our commercial organization continued to flourish in 2024 as we launched and grew three commercial products, NEFECON®, XERAVA®, and VELSIPITY®. In our renal franchise, our team successfully launched our leading drug product, NEFECON® in mainland China in May 2024. We employed a broad array of sales channels, including traditional in-person detailing of hospitals as well as the innovative channel of online prescribing, to meet the urgent and significant unmet needs of an estimated 5 million IgAN patients. Our 150-person sales team had penetrated more than 600-700 hospitals by the end-of 2024, which encompass over 60% of the addressable IgAN population. To further broaden IgAN patient access, NEFECON® was included in China's 2024 NRDL which went into effect on January 1, 2025. We expect this significantly increased affordability to drive rapid penetration of NEFECON® throughout its patient population. Another highlight for NEFECON® in 2024 was its inclusion in the "KDIGO 2024 Clinical Practice Guideline for the Management of Immunoglobulin A Nephrophthy (IgAN) and Immunoglobulin A Vasculitis (IgAV)" draft for public review. The draft guideline points out that NEFECON® is the only treatment to date proven to reduce the levels of pathogenic forms of IgA and IgA immune complexes and recommends treatment with a 9-month course of NEFECON® for patients who are at risk of progressive kidney function loss with IgAN. It also suggests that many patients may need either repeated 9-month treatment cycles or a reduced-dose maintenance regimen in order to produce a sustained clinical response in terms of proteinuria reduction or stabilization of eGFR. The safety and efficacy of repeated treatment was also supported by our partner Calliditas' global OLE study which showed consistent treatment response across endpoints of UPCR and eGFR at 9 months across all IgAN patients, including those who had previously received NEFECON® in the NefIgArd study. In our anti-infective portfolio, Everest continued to grow XERAVA® sales through deeper penetration of our covered core hospitals and we began partnering with Contract Sales Organizations to benefit patients outside of our core target hospitals, although we still anticipate our own commercial team to generate the majority of sales for XERAVA®. Eravacycline's clinical breakpoint was officially approved by ChinaCAST for clinical use in China, and more than 100 hospitals in China have already adopted the new breakpoint in 2024, facilitating wider use of the drug in clinical practice. Inclusion of eravacycline in the Catalogue of Hierarchical Management of Clinical Application of Antimicrobial Drugs in Shanghai, Beijing and Guangdong last year underscores recognition of the drug's clinical benefits by China's key opinion leaders. In addition, eravacycline was included into The Surgical Infection Society Guidelines on the Management of Intra-Abdominal Infection: 2024 Update and China's Clinical Diagnosis and Treatment Guidelines for Multidrug-resistant Bacterial Infections in Renal Transplantation, Infectious Diseases Society of America 2024 Guidance on the Treatment of Antimicrobial-Resistant Gram-Negative Infections and Chinese Expert Consensus on the Diagnosis and Treatment of Pneumonia in the Elderly (2024 Edition). Inclusion in these guidelines is expected to broaden physician awareness of XERAVA® while also encouraging broader product utilization. With the accumulation of clinical experience and the conduct of clinical studies by Chinese doctors, the following articles were published in 2024. These publications have significantly enhanced awareness and provided more references for broader clinical applications. We were pleased to have launched our first autoimmune therapeutic, VELSIPITY® which was approved in Macau in April and in Singapore in May, and successfully launched for sales in those regions. Under the "Hong Kong and Macau Medicine and Equipment Connect" policy ("the Connect Policy"), VELSITPITY® was qualified for early access in nine cities in Guangdong province and its first prescription was written at Foshan Fosun Chancheng Hospital in December. To date, VELSIPITY® has been made available at five designated medical institutions in Guangdong (First Affiliated Hospital of Sun Yat-sen University, Foshan Fosun Chancheng Hospital, Shenzhen Hospital of Southern Medical University, Guangzhou United Family Healthcare and Shenzhen Qianhai Shekou Free Trade Zone Hospital) to benefit patients in mainland China with urgent needs for advanced innovative medicines in UC. In 2025 we will continue to build on the strong commercial foundation established in 2024. In our renal franchise, we will work to rapidly ramp NEFECON® sales after its inclusion on the NRDL which makes the medicine much more affordable and broadly accessible to patients. We are targeting rapid progress in NRDL implementation through either hospital listing or dual-channel pharmacies in the first quarter of 2025. We are also aiming to expand our list of core coverage hospitals to about 800 in 2025, which includes over 80% of the potential NEFECON® market with about 200 sales representatives. Everest also anticipates official inclusion of NEFECON® in the 2025 revised Kidney Disease Improving Global Outcomes (KDIGO) guidelines as well as the first Chinese guideline for IgAN as a first-line treatment for IgAN patients. This is expected to help further grow our sales volumes by giving treating physicians an industry standard reference which instills in them more confidence in NEFECON®. While we focus on maximizing the NRDL opportunity in mainland China, we also plan to expand availability of this first-in-disease medication to more IgAN patients across other valuable Asian regions including Taiwan and South Korea. Within our anti-infective portfolio, we will continue to drive penetration of XERAVA® among our core hospitals by enhancing doctors' awareness, which would lead to more prescriptions at hospitals with significant growth potential. We will also drive early and appropriate use of XERAVA® to establish the medicine as a fundamental option in empirical multi-drug resistant bacteria infection therapy. In addition to our own sales network, we will further optimize promotion through the contract sales organization model in non-core markets where we believe XERAVA® prescription can be broadened. VELSIPITY® is our newest launch and in 2025, while we will facilitate the NDA review by NMPA with approval expected in 2026, we will also accelerate its availability in designated medical institutions under the Connect Policy for early access to VELSIPITY® in mainland China. Additionally, VELSIPITY®'s real-world study is planned in Greater Bay to provide physicians with more clinical guidance with the product. Discovery 2024 marked a remarkable year of progress in our mRNA platform as we started the first in-human trial with an investigator-initiated program for our personalized cancer vaccine, EVM16 in two top cancer hospitals in China. EVM16 is independently developed by Everest which contains neoantigens with high immunogenicity potential, predicted based on the unique tumor mutations of each patient using Everest's proprietary AI-based neoantigen prediction algorithm, EVER-NEO-1. The vaccine is designed to encode dozens of tumor neoantigens, and uses an LNP delivery system to efficiently deliver neoantigen-encoded mRNA in vivo, activating neoantigen-specific tumor-killing T cells and inhibiting tumor growth. In preclinical studies, vaccination with EVM16 stimulated a strong neoantigen-specific T cell response in different mouse models and showed significant tumor growth inhibition in the syngeneic B16F10 mouse melanoma model. EVER-NEO-1, the AI-based neoantigen prediction algorithm developed in-house by Everest, can identify the majority of reported tumor neoantigens, as well as several previously unreported neoantigens. Furthermore, the neoantigen prediction capability of EVER-NEO-1 was shown to be either comparable to or superior to leading industry algorithms in multiple independent validation studies. We are expecting a catalyst-rich 2025 with a preliminary human data readout from EVM16, for which we achieved first patient dosing in March. Additionally, we have received U.S. FDA's IND approval for EVM14, our off-the-shelf tumor-associated antigen vaccine, marking Everest's first internally discovered program and the first mRNA therapeutic cancer vaccine to be cleared for global clinical development. With IND application to China's NMPA expected in the first half of this year, this asset is designed to treat various cancers, including non-small cell lung cancer and head and neck cancer. In preclinical studies, EVM14 induced a dosedependent antigen-specific immune response in mice and significantly inhibited tumor growth in multiple syngeneic tumor models. Lastly, the in vivo CAR-T program is also expected to achieve preclinical candidate milestone later this year, which may create a pathway to future global partnership opportunities. Business Development With the promising data generated by EVER001, our most advanced product with global rights, we will look to potentially engage in out-licensing activities to create value for all our early-stage assets with global rights. For these assets, we plan to pursue global partnership opportunities and seek ways to maximize shareholder value with entities who have global expertise and deals that offer attractive economics. Our business development strategy for in-licensing remains focused on first-in-class or best-in-class assets in less crowded, high value therapeutic areas such as renal diseases, autoimmune disorders, and anti-infective categories. We intend to leverage the strength of our existing commercial platforms to pursue commercial-stage or near-commercial-stage assets in China to create operational synergies and build scale. In parallel, we plan to evaluate earlier-stage assets with global rights, where we can deliver clinical proof-of-concept results and build substantial shareholder value. Financial Highlights IFRS Numbers: Revenue for the year ended 31 December 2024 increased significantly by RMB580.7 million, or 461%, to RMB706.7 million, compared with RMB125.9 million for the year ended 31 December 2023. The revenue growth was primarily driven by the strong ramp up of XERAVA® sales and the successful launch of NEFECON® in mainland China. Additionally, in markets outside of Mainland China, XERAVA® sales continued to build in Hong Kong and Singapore, NEFECON® was successfully launched in Hong Kong and Singapore, and VELSIPITY® was first launched in Macau and made available in Guangdong province through the "Hong Kong and Macau Medicines and Equipment Connect" policy. Gross profit margin rose from 72.7% for the year ended 31 December 2023 to 74.6% for the year ended 31 December 2024. Excluding the amortisation of intangible assets, the gross profit margin increased from 79.9% in 2023 to 82.9% in 2024. The improvement was mainly due to the commercial launch of NEFECON® and the optimisation of product costs. R&D expenses for the year ended 31 December 2024 amounted to RMB528.0 million, decreasing slightly from RMB540.1 million for the year ended 31 December 2023. The Company remains committed to strategic R&D investments across various product pipelines to support long-term sustainable growth. General and administrative expenses increased by RMB84.9 million, from RMB165.2 million for the year ended 31 December 2023 to RMB250.1 million for the year ended 31 December 2024. This increase was primarily due to higher remuneration expenses and professional service expenses in order to support the Company's business expansion and continued pipeline growth. Distribution and selling expenses increased by RMB276.7 million from RMB231.4 million for the year ended 31 December 2023 to RMB508.1 million for the year ended 31 December 2024, primarily due to expansion of the commercial team and additional commercial activities, which helped the successful launch of new products and encouraged the growth of existing product sales. Our commercial operational efficiency increased as commercialization expenses-to-sales ratio decreased by 111.9%, with our continued efforts to build a more efficient and focused commercialization model. The ratio of total operating expenses (including general and administrative expenses, research and development expenses, and distribution and selling expenses) to sales decreased by 561.8%, showing operational efficiency improvement. Net loss for the year increased by RMB196.9 million from RMB844.5 million for the year ended 31 December 2023 to RMB1,041.4 million for the year ended 31 December 2024. This increase was primarily due to a one-time, non-recurring impairment loss from an intangible asset related to mRNA COVID-19 vaccines in the first half of 2024. Excluding this impairment loss of an intangible asset, net loss narrowed by RMB107.5 million, from RMB792.5 million for the year ended 31 December 2023 to RMB685.0 million for the year ended 31 December 2024. This was primarily due to the strong product sales and improvements in operational efficiency. Cash and cash equivalents and bank deposits amounted to RMB1,603.3 million as of 31 December 2024. Non-IFRS Measure: Adjusted loss for the year narrowed by RMB176.1 million, from RMB713.6 million for the year ended 31 December 2023 to RMB537.6 million for the year ended 31 December 2024, primarily excluding the one-time and non-recurring loss on impairment of an intangible asset, and non-cash expenses of share-based compensation and amortization of intangible assets. About Everest Medicines Everest Medicines is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing transformative pharmaceutical products and vaccines that address critical unmet medical needs for patients in Asian markets. The management team of Everest Medicines has deep expertise and an extensive track record from both leading global pharmaceutical companies and local Chinese pharmaceutical companies in high-quality discovery, clinical development, regulatory affairs, CMC, business development and operations. Everest Medicines has built a portfolio of potentially global first-in-class or best-in-class molecules in the company's core therapeutic areas of renal diseases, infectious diseases and autoimmune disorders. For more information, please visit its website at . Forward-Looking Statements: This news release may make statements that constitute forward-looking statements, including descriptions regarding the intent, belief or current expectations of the Company or its officers with respect to the business operations and financial condition of the Company, which can be identified by terminology such as "will," "expects," "anticipates," "future," "intends," "plans," "believes," "estimates," "confident" and similar statements. Such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, or other factors, some of which are beyond the control of the Company and are unforeseeable. Therefore, the actual results may differ from those in the forward-looking statements as a result of various factors and assumptions, such as future changes and developments in our business, competitive environment, political, economic, legal and social conditions. The Company or any of its affiliates, directors, officers, advisors or representatives has no obligation and does not undertake to revise forward-looking statements to reflect new information, future events or circumstances after the date of this news release, except as required by law. SOURCE Everest Medicines WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED