吉利德科学公司(GILD.US)2026年第二季度业绩电话会
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会议摘要
Gilead Sciences showcases significant advancements in HIV treatment, liver disease, and oncology, with strong financial performance and pipeline diversification. The company highlights its HIV portfolio expansion, FDA approvals for oncology and liver disease treatments, and strategic acquisitions enhancing its ADC and cell therapy capabilities. Financially, Gilead reports robust sales growth, particularly in HIV and oncology segments, and raises full-year guidance, reflecting disciplined operations and innovation focus.
会议速览
Gilead Sciences reported strong Q2 earnings with significant growth in HIV, oncology, and liver disease segments. Highlights include doubled HIV sales, 20% increase in Todalbe sales, and lebels disease sales more than doubling. The company also secured approvals and initiated clinical advancements, positioning for future commercial launches and market leadership.
Achieved $7.6B in total product sales, up 10% YoY, driven by HIV and liver disease treatments. HIV sales grew 12% YoY to $5.7B, with vitabile treatment and NTU go leading. Anticipating FDA decision on Btech Vir plus planetic haviva R and launch of is latavio plus linno capire for expanded leadership in HIV.
Gilead's HIV prevention business, led by its expanding portfolio of prep options, achieved significant market share growth and robust sales, with Esti Go showing impressive persistency rates and jessua leading the prep switch market. The company anticipates continued growth, targeting $1 billion in full-year sales and benefiting from pricing favorability and an expanding US prep market.
Gilead's Q2 sales growth highlighted by Lidsey's doubled sales, driven by US demand and European uptake, with promising phase III study results. Devi's exceptional 26% year-over-year growth fueled by metastatic breast cancer demand, and cell therapy sales, despite sequential drop, show readiness for new multiple myeloma treatment launches.
Gilead showcases robust clinical execution across HIV and liver diseases, emphasizing innovative acquisitions, treatment advancements, and pipeline diversification. Notable highlights include progress on novel HIV therapies, such as once-daily and once-weekly oral regimens, alongside developments in liver disease treatments, exemplified by the FDA's accelerated approval of helu deck for chronic hepatitis Delta virus infection. These efforts underscore Gilead's commitment to enhancing patient outcomes and expanding treatment options.
Gilead highlights its progress in oncology, focusing on ADCs with the Tubulus acquisition and cell therapy advancements post-Arces acquisition, aiming to lead in ADC innovation and cell therapy development, with new approvals and pipeline expansions in OVC cancer and multiple myeloma.
Gilead Sciences shared Q2 financial results showing a base business growth to $7.6 billion, driven by HIV products, trodelvy, and ladelle, with strong portfolio growth. Key clinical milestones include FDA approvals and updates on various trials, showcasing the company's disciplined operational execution and robust pipeline.
The company revises its full year sales and EPS guidance upwards, driven by strong HIV product performance and cost efficiencies. It outlines a strategy centered on integrating recent acquisitions, prioritizing shareholder returns, and maintaining focus on strategic growth opportunities while committing to operational discipline.
A discussion on E2Go's performance, focusing on the delta between prescription trends and sales data from IQVIA, highlighting growth drivers including healthcare professional confidence, market expansion, and patient education. The dialogue also touches on the company's guidance for the year, projecting a billion dollars in sales for E2Go.
The dialogue highlights the significant market opportunity for long-acting and weekly oral HIV prevention methods, emphasizing the potential for market expansion by addressing patient preferences for less frequent dosing, particularly moving from daily to weekly or monthly treatments, while noting the current dominance of daily oral generics and the future potential of injectables by 2028.
Discusses initiatives to improve adherence rates for HIV PrEP, including a new support program with SMS reminders, educational resources, and a nurse call center, aiming to boost long-term persistence beyond the current 70% compliance level.
The dialogue discusses Gilead's ongoing strategy to diversify its business beyond its dominant HIV portfolio, highlighting advancements in HIV treatment and prep, the growth of tridel be, and plans for further expansion in oncology and virology, while maintaining strong cash flow and margins.
Discussed ongoing interactions with FDA regarding potential filing for earlier line therapy using dual primary endpoints, confirming no changes in requirements despite recent leadership shifts and policy discussions.
The dialogue discusses the impact of insurance coverage losses, particularly due to the elimination of tax subsidies, on the HIV treatment market. It highlights a softer Q2 performance attributed to patients transitioning from health exchange plans. The speaker forecasts a market bounce back to 2-3% growth, driven by the strength of Viv and pre-exposure prophylaxis (PrEP) products, with an overall HIV market growth guidance raised to 9-10% for the future.
The dialogue discusses the promising potential of GS Xi 4 in non-small cell lung cancer, highlighting its efficacy and tolerability observed in other cancers. It also outlines plans to share phase 2 update data for the alpha 4 beta 7 program at an upcoming conference, emphasizing the validated target's potential for differentiation in IBD treatment.
The dialogue discusses the strategic importance of launching a new once-weekly oral HIV treatment, emphasizing its potential to enhance market leadership and expand treatment options. The speaker highlights the partnership with Mer and the anticipated positive physician response, underscoring the opportunity to innovate within the HIV treatment space.
Discusses sustaining year-over-year price benefits, anticipating sales growth, and evaluating the cannibalization impact of upcoming weekly products on existing injectables, focusing on strategic planning for future market dynamics.
The discussion highlights Dyscola's 60% year-over-year growth attributed to favorable pricing, market demand, and strategic product shifts. It anticipates continued market expansion and sees potential in two-week oral options as a complementary launch opportunity, emphasizing the switch from generics to branded products.
Discusses the phase 2 trial's dosing interval for 3242, emphasizing the goal of achieving once-every-few-months administration. Highlights the ongoing dose escalation study and the versatility of both oral and injectable applications, indicating the need for further data to confirm optimal dosing.
A discussion on the development of weekly oral HIV treatments, highlighting their potential benefits over daily options, including strong safety profiles and high barriers of resistance, as part of Phase 3 trials.
Gilead teams celebrated a strong Q2, highlighting significant advancements across therapy areas through clinical and commercial excellence. The discussion emphasized preparation for potential oncology developments, particularly in the field of needle cells, while maintaining current performance standards. Investors were encouraged to stay engaged for updates on progress.
要点回答
Q:What were the highlights of Gilead's second-quarter earnings?
A:Gilead's key achievements in the second quarter included commercial excellence with year-over-year sales growth across therapeutic areas, positive clinical execution, and the FDA decision expected later this month on the once-daily oral treatment combining BTV rilagu and leno-capavibale.
Q:How did Gilead's oncology business perform in the second quarter?
A:Gilead's oncology business saw sales of Trodelvy up 20% year-over-year, reflecting strong demand across both triple-negative and pretreated HER2-negative metastatic breast cancer. Additionally, Trodelvy secured new approvals in the first line treatment of metastatic triple-negative breast cancer across PDL-1 status.
Q:What were the results in Gilead's liver disease business?
A:Gilead's liver disease business experienced significant growth with sales of Lodesivir more than doubling year-over-year. The drug continues to gain momentum as the leading second-line treatment for primary biliary cholangitis (PBC). Positive phase II data further support the opportunity for Lodesivir to reach more patients with PBC. Hepcidox was also launched in the U.S. this quarter as the first and only FDA-approved treatment for chronic hepatitis Delta virus (HCV).
Q:What was the overall financial performance of Gilead's products?
A:Gilead's total product sales, excluding De, were $7.6 billion for the second quarter, marking a 10% year-over-year increase. Sequentially base business sales were up 12%, driven by strength across each of Gilead's therapeutic areas.
Q:What are the updated expectations for full-year HIV sales?
A:Gilead has updated its full-year HIV sales growth expectations to a range of 9% to 10% compared to the prior year, up from the previous guidance of 8% growth. This is attributed to continued strong growth in Viterbi, TAF, and Dolutegravir, as well as higher average realized prices and increased demand.
Q:What are the expectations for viscose sales growth and market expansion?
A:Viscose is expected to drive robust full-year growth due to pricing favorability and demand growth, with an expanding US prep market. The total prep business is operating at an annual run rate of $4 billion, and the company has a diverse pipeline of new prevention options in development.
Q:How is the new positive result from the phase Iii ideal study expected to impact lidell Z's market position?
A:The new positive results from the phase Iii ideal study are expected to enable potential expansion of lidell Z's leadership in the second line PBC population as early as next year.
Q:What recent FDA approvals have been received for tridadi in first line metastatic TNBC and what is their potential impact?
A:Recent FDA approvals for tridadi in first line metastatic TNBC, across PDL one status, nearly double the addressable population and extend the opportunity to benefit patients following NCCN guideline updates. This is expected to further cement tri-delta as the backbone of treatment in metastatic TNBC.
Q:What are the plans and preparations for the potential launch of the needle cell therapy?
A:The company has begun extensive launch readiness activities including optimizing sales, medical, and access teams, conducting pre-activation work, initiating contractual reviews, quality training, and engaging with payers to ensure broad and timely access. They are confident in the needle cell's profile and are encouraged by the strong interest received ahead of the potential launch.
Q:How is the HIV pipeline expanding and what are the anticipated developments for people with HIV?
A:The HIV pipeline is expanding with the addition of new daily and longer-acting orals and injectables for people with HIV. The company is evaluating potential new additions to their treatment portfolio, such as once daily Vitagraph plus lenacapavir or Vile for virally suppressed people with HIV, and is making progress on a novel oral regimen for the switch population. They are also advancing a twice-yearly treatment regimen using lenacapavir with investigational wholly owned long-acting Integra inhibitors.
Q:What is the FDA's role with respect to the once-weekly oral and acapela for HIV prevention?
A:The FDA has accepted the filing for once-weekly oral and acapela for HIV prevention, which is supported by the robust clinical profile of the drug from pivotal phase three trials. It is anticipated that the FDA will consider adding the first long-acting oral prevention option to Gilead's industry-leading portfolio.
Q:What is the significance of the FDA's accelerated approval of helu deck for chronic hepatitis Delta virus infection?
A:The FDA's accelerated approval of helu deck, the first and only FDA approved treatment for chronic hepatitis Delta virus infection, is significant because chronic hepatitis Delta is considered the most severe form of viral hepatitis with rapid disease progression towards liver failure and death. Helu deck has been available in the EU since July.
Q:What were the positive results from the Phase II ideal study regarding the delsey in patients with PBC?
A:The positive results from the Phase II ideal study evaluating delsey in patients with primary biliary cholangitis (PBC) showed statistically significant composite alkaline phosphatase normalization in patients whose disease remains inadequately controlled with alkaline phosphatase levels between 3 and 11 x the upper limit of normal.
Q:What recent acquisitions and developments have been made in Gilead's oncology research?
A:Gilead has made several developments in oncology research, including closing the acquisition of Tubulus and its next-generation ADC platform, alongside the continued development of the Edo binder platform for future cell therapy. The acquisition of Tubulus and the presentation of updated safety and efficacy data from the Phase 1 study on GS 8824 in platinum-resistant ovarian cancer were key developments.
Q:What progress has been made in the development of GS 8824 and other ADCs at Gilead?
A:Gilead has made progress in developing GS 8824, a directed ADC, which demonstrated deep and durable responses in a platinum-resistant ovarian cancer study. The company has initiated a phase III clinical program in platinum-resistant ovarian cancer and is planning to enter further registrational development. Gilead's pipeline also includes a phase I clinical program in platinum-sensitive ovarian cancer and other advanced tumor types, and they continue to evaluate other potential research-stage candidates utilizing their Culet platform technologies.
Q:What is the potential of Alito in the treatment of multiple myeloma and what are the plans for its further development?
A:With full control of Alito sales development, Gilead aims to maximize the long-term potential of allogeneic cell therapy, including in the treatment of multiple myeloma. The company is focusing on further developing the Ddom binder platform with deep and durable efficacy and a differentiated safety profile. Gilead has completed enrollment in the phase II imagine II study in second-line multiple myeloma and plans to potentially file for regulatory approval as early as 2023.
Q:What is the Kite team's in vivo platform and how does it differ from existing class challenges?
A:The Kite team's in vivo platform is designed to address class challenges of durability, safety, and manufacturing feasibility, and to provide scalability for broad expansion across oncology and autoimmune diseases. This platform enables multiple antigen targeting and utilizes a modular interior that allows for the optimization of car constructs and vector targets by disease, facilitating rapid development and improved operational efficiency.
Q:What are the key factors contributing to Gilead's quarterly results?
A:The key factors contributing to Gilead's quarterly results include the strength and durability of Gilead's portfolio, disciplined operational execution, growth across HIV products, and the continued success of trodelvy and ladal. Sales were up year over year, and sequentially, they were driven by various factors, with the base business growing and other revenue contributing to the overall financial performance.
Q:What were the non GAAP results for the second quarter?
A:The non GAAP results for the second quarter include product gross margin, which was ed year over year and in line with the year's performance. There was an activity related to higher expenses, primarily reflecting the acquisitions of the recently acquired IPR and D. The non GAAP operating margin was negative ions, which is consistent with the strong margins delivered in prior quarters, and it remained in the top quartile of the peer group.
Q:What is the non GAAP diluted EPS and how has it been affected by the acquisitions?
A:The non GAAP diluted EPS for the second quarter was negative 6 dollars 75 cents. This was influenced by higher revenue and adjusted for the acquisitions of arceli, butus, and oral medicines. Excluding these acquisitions, non GAAP diluted EPS would have been $200 script cents.
Q:How has Gilead's business model demonstrated leverage in the recent period?
A:Gilead's business model has demonstrated leverage as the illustrative EPS has grown approximately ed compared to the same period last year, which is a favorable comparison to the total product sales growth of ed in the second quarter and ed in the first half of the year.
Q:What updates have been provided for full year sales and EPS guidance?
A:The full year sales and EPS guidance updates indicate that Gilead now expects base business sales to grow approximately script to script year over year, with a range between 29.8 and $30.1 billion. The company has also adjusted its expectations for total product sales to be in the range of ed ed and $30.4 billion. Furthermore, the updated guidance includes a lower end of the range for acquired IPRD expenses and an expectation of increased expenses for R&D and SG&A.
Q:What priorities does Gilead have in terms of future acquisitions and integration?
A:Gilead's near-term priorities include integrating the new programs and platforms into their business. They do not currently anticipate pursuing additional sizable M&A transactions for the remainder of the year but will remain opportunistic and continue to assess strategic opportunities to enhance their portfolio and create value.
Q:What percentage of the total market is still available for a weekly oral PrEP medication?
A:There is an 85% of the total market that is still available for a weekly oral PrEP medication, which represents a significant opportunity for market expansion.
Q:What steps is the company taking to increase compliance with the current PrEP medications?
A:The company is working on compliance initiatives such as using electronic health records (EHR) and medical reminders to ensure PrEP persistency. They've also launched a support program called 'Ready to Go' that includes SMS reminders, educational resources, patient support links, and a nurse call center.
Q:What is the new support program 'Ready to Go' designed to achieve for PrEP users?
A:'Ready to Go' is designed to help PrEP individuals start and stay on the medication for the long term by providing SMS reminders, educational resources, links to patient support, friendly nudges, and access to a nurse call center.
Q:What are the ongoing and upcoming strategies to maintain and possibly improve the persistency rates of PrEP?
A:Ongoing strategies include promoting awareness about HIV prep and the benefits of long-term use of PrEP. Upcoming strategies involve diversifying the HIV business across various treatment options, acquiring companies like Tubul, and providing more information about the pipeline.
Q:Is Gilead still prioritizing diversifying its core therapeutic areas despite its strong performance in HIV treatment and PrEP?
A:Yes, Gilead continues to prioritize diversification of its core therapeutic areas, having worked on this in different ways over time. This includes the ongoing development of new options within HIV treatment and PrEP, as well as exploring acquisitions and expanding into oncology.
Q:What is the status of the clinical trials for the new PrEP options and potential filing dates?
A:The company is awaiting approval for a new daily oral PrEP option by the end of the month, which is expected to be a significant step in diversifying the HIV treatment portfolio.
Q:What recent progress has been made in Gilead's oncology and other non-HIV areas?
A:Gilead has seen recent growth in the oncology drug trabec, with a year-over-year increase of 20% and is approaching a $2 billion run rate. There is also excitement for the launch of new drugs like Breyanzi, and the company anticipates sharing more information on these areas later in the year.
Q:What impact did the elimination of tax subsidies have on sales?
A:The elimination of tax subsidies led to a situation where some patients became uninsured, impacting their ability to purchase insurance plans, and consequently affecting the treatment market. This had a softening effect on Q2 sales, with a year-on-year growth of 7% and quarter-over-quarter growth halting. However, it is expected that this impact will reverse and return to the 2 to 3% growth range.
Q:What is the anticipated impact of the loss of insurance coverage on the treatment market?
A:The anticipated impact of the loss of insurance coverage on the treatment market is expected to be a transition of patients, resulting in a softer Q2. However, it is believed that this impact will reverse and that the market will return to the 2 to 3% growth trend previously observed.
Q:What is the potential of GS-8008242 in non-squamous cell lung cancer?
A:The potential of GS-8008242 in non-squamous cell lung cancer is considered particularly interesting because it is expressed in non-squamous cell lung cancer and early data from trials are quite encouraging. The efficacy and tolerability observed in the trials suggest there is an opportunity for GS-8008242 to be a top-line treatment in non-small cell lung cancer, although it is considered still in early days and more data is needed.
Q:What is the planned update for the alpha for beta 7 program?
A:The planned update for the alpha for beta 7 program will be shared at the Medics conference later in the year. The update will include phase 2 trial data with an emphasis on clinical remission and dysplasia remission, as well as an IBD endpoint. The program is a validated targeted approach, and the data is expected to demonstrate the potential of the treatment.
Q:How should the introduction of Len and Vir shape expectations for the HIV treatment market?
A:The introduction of Len and Vir should shape expectations for the HIV treatment market by expanding or switching leadership in the space. With the anticipated launch of Len in 2027, there is a positive physician response for the once-weekly oral option. The partnership with Merck, along with the current leadership in the naive market, provides an opportunity to really expand market leadership in HIV treatment.
Q:What is the expected cannibalization impact of weekly oral medications on existing treatments?
A:The expected cannibalization impact of weekly oral medications, specifically on existing treatments like Stribildi, is uncertain. While there has been no significant cannibalization so far, with the introduction of the weekly oral, it is anticipated that there could be a shift from existing injectable treatments to the new weekly oral options, especially among patients who have been on a different treatment and are comfortable with it.
Q:What is the projected dosing interval for the phase 2 trial of 3242?
A:The projected dosing interval for the phase 2 trial of 3242 is not clear from the provided text, as it was described as a 'pending' detail that required further data to confirm.
Q:What considerations should be made when switching to the new weekly oral treatments?
A:When considering switching to the new weekly oral treatments, several factors should be taken into account. These include the molecule, mechanism, and full phase 3 data, as well as potential pros and cons relative to available treatments and newer daily options. The new treatments combine Lannate with GS 1720 or GS 3242, which are integrase inhibitors, and could be preferred due to strong safety profiles and resistance barriers, as per the understanding of current HIV treatment guidelines.

Gilead Sciences, Inc.
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