Gilead Sciences develops and commercializes medicines for HIV, viral hepatitis, COVID-19 and cancer. Company updates regularly cover product sales and operating results, HIV franchises such as Biktarvy, Yeztugo and lenacapavir, and clinical or regulatory activity for investigational HIV regimens that combine established antiretroviral agents with newer mechanisms.
Recurring developments also include oncology pipeline expansion through Kite cell-therapy programs, the completed acquisition of Arcellx and its investigational BCMA-directed CAR T-cell therapy anitocabtagene autoleucel for multiple myeloma, collaboration activity using real-world evidence in oncology R&D, shareholder matters, and capital-structure disclosures tied to material agreements and acquisitions.
Gilead Sciences (NASDAQ: GILD) will present over 70 clinical and real-world abstracts at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting from Nov. 4-8, 2022. Key highlights include analyses from studies on Hepcludex (bulevirtide) for chronic hepatitis delta virus and an investigational HBV vaccine. Findings show Hepcludex's safety and efficacy and explore new treatment strategies for chronic hepatitis B and C. Gilead emphasizes its commitment to addressing unmet liver disease needs.
Gilead Sciences reported a 5% decline in total revenue to $7.0 billion for Q3 2022, primarily due to falling sales of Veklury®, offset by increases in HIV and oncology products. Notably, sales of Biktarvy® rose 22% to $2.8 billion, and oncology sales surged 79% to $578 million. EPS decreased to $1.42 from $2.05 in 2021. Gilead adjusted its full-year guidance to anticipate $25.9-$26.2 billion in total product sales, up from earlier estimates. The company also generated $2.9 billion in operating cash flow while repaying $1.0 billion in debt.
Gilead Sciences presented new data from the BICSTaR study on its HIV treatment Biktarvy at the 30th International Congress on Drug Therapy in HIV Infection. The results show that after 24 months, 97% of treatment-naïve and 95% of treatment-experienced participants achieved viral suppression. Additionally, over 99% of participants remained suppressed at 240 weeks in follow-up studies, demonstrating the long-term efficacy and safety of Biktarvy. The FDA has updated Biktarvy's label to include data from these trials.
Kite, a Gilead Company (Nasdaq: GILD), has signed a worldwide license agreement with Refuge Biotechnologies for exclusive rights to its gene expression platform aimed at developing treatments for blood cancers. This partnership seeks to enhance CAR T-cell therapies' efficacy and safety through innovative gene regulation. Kite will assume all costs related to research and commercialization and will make an upfront payment to Refuge, which may also receive milestone payments based on performance. Kite aims to broaden patient access to CAR T therapies with this collaboration.
Gilead Sciences (GILD) announced new data on its HIV treatments to be presented at the 30th International Congress on Drug Therapy in HIV Infection from October 23-26, 2022. Key findings include:
- Long-term efficacy of Biktarvy in treatment-naïve and treatment-experienced patients.
- Insights from the BICSTaR study supporting Biktarvy's safety and effectiveness.
- New results on lenacapavir, highlighting its efficacy among multi-drug resistant HIV patients.
These presentations reflect Gilead's commitment to addressing the evolving needs of HIV-affected individuals.
Gilead Sciences (Nasdaq: GILD) announced that the European Commission approved Yescarta for adult patients with diffuse large B-cell lymphoma (DLBCL) who relapse or are refractory after first-line treatment. The approval stems from the pivotal ZUMA-7 study, showing Yescarta provides an event-free survival (EFS) of 8.3 months compared to just 2.0 months with standard care, marking a four-fold improvement. Additionally, Yescarta patients showed a 2.5 fold increase in survival without cancer progression at two years (41% vs. 16%).
Gilead Sciences (NASDAQ: GILD) has secured an exclusive option for the MGD024 molecule, a bispecific antibody targeting CD123 and CD3, through a collaboration with MacroGenics (NASDAQ: MGNX). This molecule aims to treat blood cancers such as acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS). Gilead has committed $60 million upfront, with a total potential of $1.7 billion in milestones. The Phase 1 study will assess MGD024's efficacy and safety while Gilead may opt to license it at set decision points.
Gilead Sciences, Inc. (Nasdaq: GILD) will release its third quarter 2022 financial results on October 27 after market close. Following the announcement, management will host a webcast at 4:30 p.m. Eastern Time to discuss results and provide a business update. The webcast will be accessible on Gilead's Investor Relations website and archived for one year. Gilead focuses on developing innovative medicines for serious diseases, including HIV, hepatitis, and cancer, operating in over 35 countries from its headquarters in Foster City, California.
Gilead Sciences, Inc. announced that the FDA accepted its supplemental Biologics License Application (sBLA) for Trodelvy to treat adult patients with unresectable HR+/HER2- metastatic breast cancer who have received prior therapies. The sBLA is based on positive data from the TROPiCS-02 study, showing significant improvements in progression-free survival (PFS) and overall survival (OS) compared to chemotherapy. The PDUFA target date is set for February 2023. While Trodelvy has not yet been approved for this indication, it has shown promise in changing treatment landscapes for breast cancer.
Kite, a Gilead Company (Nasdaq: GILD), has received FDA approval for its retroviral vector manufacturing facility in Oceanside, California. This facility is crucial for producing viral vectors, which are essential in Kite's CAR T-cell therapies aimed at treating blood cancers. Kite stands out as the only cell therapy company with both commercial and clinical trial viral vector manufacturing capabilities. The in-house production will enhance reliability and scalability, meeting increasing patient demand for these therapies.