Yahoo Finance Gilead Sciences, Inc. (NASDAQ:GILD) Q1 2024 Earnings Call Transcript
Gilead Sciences, Inc. (NASDAQ:GILD) Q1 2024 Earnings Call Transcript April 25, 2024
Gilead Sciences, Inc. beats earnings expectations. Reported EPS is $-1.32, expectations were $-1.49. Gilead Sciences, Inc. isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Good afternoon, everyone, and welcome to Gilead's First Quarter 2024 Earnings Conference Call. My name is Rebecca, and I'll be your host for today. In a moment, we'll begin our prepared remarks. [Operator Instructions] I'll now hand the call over to Jacquie Ross, VP, Investor Relations and Corporate Strategic Finance.
Jacquie Ross: Thank you, Rebecca. Just after market closed today, we issued a press release with earnings results for the first quarter of 2024. The press release, slides and supplementary data are available on the Investors section of our website at gilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day; our Chief Commercial Officer, Johanna Mercier; our Chief Medical Officer, Merdad Parsey; and our Chief Financial Officer, Andrew Dickinson. After that, we'll open Q&A where the team will be joined by Cindy Poretti, the Executive Vice President of Kite. Before we get started, let me remind you that we will be making forward-looking statements. Please refer to Slide 2 regarding the risks and uncertainties relating to forward-looking statements that could cause actual results to differ materially. With that, I'll turn the call over to Dan.
Daniel O'Day: Thank you Jacquie, and good afternoon, everyone. I want to start by thanking the Gilead teams for delivering a strong first quarter, which you see in our commercial performance and our clinical execution. Total product sales, excluding Veklury grew 6% year-over-year to $6.1 billion, driven by higher demand across HIV, oncology and liver disease. Veklury sales continue to track with the rates of hospitalization for COVID-19 and reached a total of 555 million. Once again, sales growth for the quarter reflected the diversity of our portfolio. HIV product sales grew 4% year-over-year. Oncology product sales were up 18%, driven by Trodelvy, which is well established as the number one regimen for second-line metastatic triple-negative breast cancer and by our transformative cell therapies.
As we outlined at the recent Kite analyst event in Maryland, we have exciting plans to build on our clear market leadership in cell therapy, such as expand into community networks in the U.S., more than double our manufacturing capacity, and move into new indications and disease areas with next-generation products. From an EPS perspective, first-quarter results reflect the close of the CymaBay Acquisition with an acquired IPR&D Charge of $3.9 billion, or an expense of $3.14 per share. Excluding this charge, non-GAP diluted EPS would have been $1.82 for the first quarter, which is above expectations driven by higher product sales. The CymaBay acquisition brings us an important registrational medicine, seladelpar, which has the potential to address significant unmet need in liver disease.
We have filed for regulatory approval of seladelpar as a treatment for primary biliary cholangitis, or PBC, with both FDA and EMA, and we expect an FDA regulatory decision in August. If approved, we will leverage our industry-leading commercial infrastructure and longstanding expertise in liver disease to bring seladelpar, a potentially transformative therapy, to people with PBC who might benefit. Moving to clinical execution, we're very pleased with the momentum in our HIV pipeline, which was reflected in our 80 data abstracts at CROI. Based on the strength of the data, we've initiated Phase 3 trials for bictegravir and lenacapavir, our novel once-daily oral regimen, and plan to advance once-weekly oral programs, including lenacapavir plus islatravir, into Phase 3.
Later this year, we will host an HIV analyst event to share details of how we will further shape the HIV landscape with innovative options for prevention and treatment, including the next wave of long-acting therapies. Before I pass it to Johanna, I will briefly recap our 2024 milestones on slide six. We have already achieved first patient in for the Phase 3 ARTISTRY-I and ARTISTRY-2 trials, evaluating once-daily lenacapavir in combination with bictegravir, as well as Phase 2 first patient in for SWIFT, evaluating GS-1427, our oral alpha-4 beta-7 inhibitor. We are also on track for our upcoming milestones, including updates from 3 Phase 3 clinical trials for trodelvy and lenacapavir. Looking ahead to the rest of 2024, this is a time of focused execution for Gilead.
We will stay disciplined and agile in our approach, and we will focus the organization on both near-term execution and longer-term plans. With 54 clinical programs in play, no major patent expiries through the end of the decade, and many opportunities for growth, we have a lot of potential and a lot to deliver. My thanks again to the Gilead teams for their great work this quarter and the ongoing progress across our diverse portfolio of therapies. With that, I'll hand it over to Joanna.
Johanna Mercier: Thanks, Dan, and good afternoon, everyone. With the first quarter marking the ninth consecutive quarter of year-over-year growth for our base business, our teams delivered a strong start to 2024, notably navigating the seasonal first quarter dynamics and establishing a firm base on which we can continue to build this year. Beginning on slide eight, total product sales, excluding Veklury, were $6.1 billion for the first quarter, up 6% year-over-year, reflecting solid growth across our HIV, oncology, and liver disease businesses. Including Veklury, total product sales were $6.6 billion, up 5% year-over-year. Moving to HIV on slide nine, sales were up 4% year-over-year to $4.3 billion, primarily driven by higher demand as well as favorable pricing dynamics in Europe that are not expected to repeat.
Quarter-over-quarter sales were down 7%, driven by the typical seasonality we experienced in the first quarter of the year, partially offset by higher demand. As a reminder, quarterly HIV growth is in general more variable and less indicative of overall trends than the full year. This is evident in the first quarter of every year, where inventory drawdown typically occurs following a build that generally happens towards the end of the prior year, and patient co-pays and deductibles reset at the start of every year, and together with shifts in channel mix lowers average realized price in the first quarter. As always, we typically see these quarterly pricing and inventory dynamics normalize as we progress throughout the year. We continue to expect approximately 4% HIV sales growth for 2024.
Supporting that outlook, the treatment market grew in line with our expectations as shown on slide 10. Biktarvy remains the leading regimen for HIV treatment across major markets for new starts as well as for those switching regimens with sales up 10% year-over-year to $2.9 billion, reflecting strong demand. Quarter-over-quarter, sales were down 5% as the higher demand was offset by the typical seasonal factors discussed earlier. It's notable that six years after launch, Biktarvy continues to gain market share in the U.S., up three percentage points year-over-year to approximately 49% share, and once again outpacing all other branded regimens for HIV treatment. Moreover, we continue to see Biktarvy’s benefit extend into broader populations of people with HIV.
Most recently, Biktarvy was granted FDA approval for use in virologically suppressed individuals with known or suspected M184 resistance, a common form of treatment resistance. Turning to prevention, Descovy sales were down 5% year-over-year to $426 million, driven by lower average realized price due to channel mix, partially offset by higher demand. Sequentially, sales were down 16%, reflecting the seasonal dynamics discussed earlier, partially offset by higher demand. While market volumes in February were temporarily disrupted by the cyberattack on Change Healthcare, volumes readily recovered in March. Overall, the PrEP market continued to demonstrate robust growth, up over 11% in the first quarter, with Descovy maintaining over 40% PrEP market share in the U.S., despite the availability of other regimens, including generics.
This is a solid setup as we look to potentially launch Lenacapavir as early as late next year, as the first and only twice yearly subcutaneous prevention option. Given Gilead's strong commercial foundation across treatment and prevention, we are well positioned to maintain leadership in HIV as we look to the evolving marketplace of daily orals, long acting orals, and long acting injectables. Moving to liver disease on slide 11, sales for the first quarter were $737 million, up 9% year-over-year, primarily driven by favorable inventory dynamics and the timing of purchases by the Department of Corrections for our HCV products, as well as higher demand across HCV, HBV, and HDV. Sequentially, sales were up 7%, primarily reflecting the timing of HCV purchases.
Despite fewer HCV starts globally year-over-year, our viral hepatitis portfolio overall has remained stable and continues to be a meaningful contributor to our commercial performance. This strength is underpinned by our extensive global footprint and expertise in the treatment of liver diseases. To that end, pending approval, Gilead is excited to bring seladelpar to patients for the treatment of certain adults with PBC, impacting approximately 130,000 people in the U.S. and about 125,000 people in Europe. With a sales force that covers almost 80% of the U.S. prescriber base for PBC, we expect to readily make seladelpar available to patients upon approval in the second half of this year. Seladelpar has demonstrated the potential to be best-in-class with a differentiated clinical profile to existing and emerging therapies, particularly on a key symptom of the disease, pruritus.
Following its launch in 2024, we expect seladelpar to contribute modestly to sales and more meaningfully in 2025 and beyond. Turning to slide 12, Veklury continues to be the standard-of-care antiviral for hospitalized patients treated with COVID-19, with market share well over 60% in the United States. COVID-related hospitalizations were lower in the first quarter with the winter wave peaking earlier than expected in the U.S. and Europe as compared to other regions such as Japan. As a result, Veklury sales overall were down 3% year over year and down 23% sequentially to $555 million. Shifting to oncology on slide 13, sales were up 18% year-over-year to $789 million and are now firmly above a $3 billion annual runway. Having treated over 50,000 patients to date, we look forward to bringing our portfolio of medicines and future treatments across lines of therapies and tumor types to many more patients around the world.
Moving to slide 14, Trodelvy sales for the first quarter exceeded $300 million, up 39% year-over-year, reflecting continued demand. Sequentially, sales were up 3%, primarily driven by demand outside the U.S., as well as unfavorable fourth quarter pricing dynamics in Europe that did not repeat. This was partially offset by inventory dynamics in the U.S., where we saw a drawdown in the first quarter. Overall, Trodelvy’s strong market share reflects its awareness amongst providers and patients. In second line metastatic triple negative breast cancer, Trodelvy remains the leading regimen with approximately one third share in the U.S. And in the pretreated HR positive HER2 negative metastatic breast cancer setting, Trodelvy has demonstrated continued adoption, most notably in the IHC0 setting.
We are confident Trodelvy continues to differentiate itself with its safety profile and clinically meaningful survival benefits, with over 30,000 patients across tumor types already treated to date. We look forward to potentially extending Trodelvy’s reach to many more patients in the years ahead, particularly in bladder cancer, earlier line breast cancer settings and lung cancer. Turning to slide 15, and on behalf of Cindy and the Kite team, cell therapy sales were $480 million in the first quarter at 7% year-over-year. Sequentially, sales were up 3% in line with our guidance of flat to slightly up. We're pleased to see continued demand for Yescarta and Tecartus in both existing and new markets across Europe and other geographies, such as in Japan, where we've seen good progress in growing brand share and expanding our network of authorized treatment centers to over 20 to date.
In the U.S. and consistent with our recent updates, we see opportunity for growth through expanding the number of authorized treatment centers and affiliated satellites, while also driving increased referrals from the community setting. For example, we're proud to have established our flagship community collaboration with Tennessee Oncology in the first quarter. We've identified many critical learnings on how we can partner effectively with community oncology practices for cell therapy, and we will continue to refine this blueprint so that we become more efficient at onboarding new centers over time. We expect to start seeing the impact from this initiative towards the end of 2024. Wrapping up the first quarter, we had a strong start to the year, primarily driven by higher demand across each of our core businesses year-over-year.
We look forward to carrying this momentum through to approval. I'd like to thank the commercial teams and cross-functional partners across Gilead and Kite for their strong execution as we diligently expand our therapies to new populations, positively impacting more people all around the world. And with that, I'll hand the call over to Merdad.
Merdad Parsey: Thank you, Johanna. We've had a busy first quarter at Gilead with a cadence of clinical readouts that will continue throughout the rest of the year. Importantly, we anticipated an FDA regulatory decision on seladelpar and three phase three updates across HIV prevention, bladder cancer, and breast cancer. Starting on slide 17, we continue to progress our industry-leading virology pipeline, which is building momentum following a data-rich presence at CROI in March. This included robust biologic suppression data from our once-daily oral combination of bictegravir with lenacapavir from the Phase 2 portion of the ARTISTRY-1 trial. This novel combination has the potential to benefit people with HIV on complex regimens.
We have since started two Phase 3 trials of this combination, one in virologically suppressed individuals and another in virologically suppressed treatment-experienced individuals. We expect to complete enrollment in the first half of 2025. We also have two once-weekly oral programs, first a combination of lenacapavir with Merck's NRTTI, is islatravir, and virologically suppressed people with HIV, expected to advance into phase 3 later this year. Second, a combination of a capsid inhibitor with GS-1720, our novel oral integrase inhibitor. We're working to advance this combination into a Phase 2 study. The second program has the potential to be the first once-weekly oral regimen containing an INSTI agent. INSTIs are the standard-of-care treatment for HIV and an important treatment option for clinicians who continue to prefer INSTI-based regimens.
Finally, we presented Phase 1b data from our twice-yearly parenteral program of Lenacapavir plus our two broadly neutralizing antibodies for people with HIV at CROI. And we intend to share data from the Phase 2 study in the second half of this year. Moving to PrEP, we plan to share an update from our Phase 3 Purpose 1 trial in the second half of this year. Data from Purpose 1, together with data from PURPOSE-2, is expected to support the filing of lenacapavir for HIV prevention. This PrEP option would not only offer a convenient dosing schedule as a first twice yearly subcutaneous regimen, but could also be transformative in terms of adherence to HIV prevention regimens. Turning to slide 18, our Trodelvy program continues to be evaluated across a range of solid tumors with seven Phase 3 trials currently underway across breast, bladder, and metastatic non-small cell lung cancers, with plans to start the Phase 3 trial in endometrial cancer later this year.
Abstract titles were just released yesterday for the upcoming ASCO meeting, and we're pleased to have over a dozen oncology presentations this year. We will be presenting late-breaking Phase 3 data from our second line plus metastatic non-small cell lung cancer trial, EVOKE-1. Updated data from first line PD-L1 high subjects in cohort A of the Phase 2 EVOKE-2 trial will also be shared. We plan on providing updates from cohort C and D evaluating Trodelvy plus Pembro and chemotherapy in PD-L1 all comers at a medical congress in the second half of this year. In addition, presentations for both the Phase 2 EDGE-Gastric trial and the Phase 2 ARC-9 studies will be highlighted. Depending on the timing of event accruals, we anticipate two more Phase 3 updates this year for Trodelvy.
These include overall survival data from our confirmatory Phase 3 bladder cancer study, TROPiCS-04, that could support Trodelvy’s submission for full regulatory approval in the U.S. and enable ex-U.S. filings. In TNBC, where Trodelvy is the only ADC to have demonstrated statistically significant improvement in overall survival in the second line setting, we expect to share an update on the Phase 3 ASCENT-03 trial in first line PD-L1 negative patients later this year. Moving on to cell therapy, I'm pleased to share Kite's approach to the development of novel cell therapies that Cindy and the team presented at last month's investor event. As you can see on slide 19, Yescarta and Tecartas established Kite as a leader in cell therapy, and we plan to potentially extend this leadership into multiple myeloma while also paving the way for innovative next generation constructs.
On Anito-cel in later line multiple myeloma, we expect to provide a Phase 2 iMMagine-1 trial update in the second half of this year. This update follows the highly encouraging Phase 1 data presented at ASH last year, where Anito-cel demonstrated durable responses with median progression-free survival not yet met at 26.5 months median follow up, and no cases of Parkinsonian symptoms observed in the trial. For our next generation cell therapy assets, we have Bicistronic and optimized manufacturing constructs in Phase 1 trials, which are aimed at overcoming resistance mechanisms, providing potentially deeper and more sustained responses, and improving product potency. Beyond that, we have early research in allogeneic and in vivo-CAR, with plans to expand into a range of other disease areas, such as multiple myeloma with Anito-cel, solid tumors, and autoimmune diseases.
Moving to inflammation on slide 20, we recently completed our acquisition of CymaBay and added seladelpar, an investigational PPAR delta agonist to our portfolio. In Phase 3 clinical trials, seladelpar demonstrated significant improvement in both pruritus and markers of Cholestasis related to the risk of progression for PBC. As previously announced, FDA and EMA accepted our regulatory filings for seladelpar for the management of PBC in certain adult patients. We anticipate an FDA regulatory decision by August 14th, and a decision from European regulators early next year. We continue to work with global regulatory authorities to expand the reach of seladelpar for PBC patients. Further, as we look at the rest of our inflammation pipeline, we have several early phase assets that have progressed into Phase 2 trials, including our potentially first-in-class oral TPL2 inhibito, a potentially best in class oral alpha4beta7 integrin, and an oral IRAK4.
Wrapping up on slide 21, we continue to progress on our clinical milestones for the year, and we have had two first patients in and one data readout completed in the first quarter, and we remain on track for our remaining milestones. And now I'll hand the call over to Andy.
Andrew Dickinson: Thank you, Merdad, and good afternoon, everyone. Beginning on slide 23, it was a strong start to the year with our base business up 6% year-over-year. The solid growth achieved across HIV, oncology, and liver disease offset the decline in Veklury with total product sales up 5% year-over-year to $6.6 billion. As expected, our base business was down quarter-over-quarter, primarily driven by seasonal inventory and pricing dynamics in HIV. Moving beyond our revenue results, two items significantly impacted our EPS performance in the first quarter as shown on slide 24. First, our GAAP and non-GAAP results included an acquired IPR&D charge of $3.9 billion, or $3.14 per share, associated with the close of the CymaBay acquisition.
As an asset acquisition, this transaction was fully expensed in the first quarter. This was a non-deductible expense item, and as a result impacted our effective tax rate. Excluding this expense, our non-GAAP EPS would have been $1.82 for the first quarter above expectations, primarily driven by higher sales. The second item shown on the right-hand side is an impairment charge that is included in our GAAP results and excluded from our non-GAAP results. As a reminder, this relates to the carrying value of the IPR&D indefinite live intangible assets acquired from Immunomedics. At the end of 2023, the carrying value was $5.9 billion, all associated with non-small cell lung cancer. As a result of the EVOKE-01 readout in late January, we have reassessed and reduced the remaining value to $3.5 billion.
This primarily reflects the smaller addressable market that Trodelvy could serve among second-line plus metastatic non-small cell lung cancer patients, a delay in expected launch timing and associated competitive activity. We remain confident that Trodelvy will deliver attractive returns over time, with sales now exceeding $1 billion a year, a strong IP portfolio, and a development program with multiple shots on goal in new indications, as well as earlier lines of therapy, including some opportunities not included in our initial deal model. In the meantime, you can see that the impairment impacted first-quarter GAAP EPS by $1.46 per share. Moving to the rest of our non-GAAP results on slide 25. For the first quarter, product gross margin was down modestly to 85.4%, primarily due to product mix.
R&D and SG&A were each down 2% year-over-year. This is the second consecutive quarter of operating expense declines on a year-over-year basis, reflecting our continued focus on disciplined expense management. Our effective tax rate in the first quarter was a negative 30%, reflecting the non-deductibility of the CymaBay acquired IPR&D charge. Overall, our diluted earnings per share was a negative $1.32, compared to a positive $1.37 for the same period last year, primarily reflecting the $3.14 per share expense related to the CymaBay acquisition. Switching to full-year guidance on slide 26, there is no change to our revenue expectations for 2024 at this time. We continue to expect total product sales in the range of $27.1 billion to $27.5 billion, and we continue to expect total product sales, excluding Veklury, in the range of $25.8 billion to $26.2 billion, representing growth of 4% to 6% for our base business year-over-year.
Additionally, there's no change to our Veklury guidance of approximately $1.3 billion for the full year. As discussed last quarter, we do not expect to update our Veklury guidance until our third quarter earnings call apps in a very clear trend in COVID-19 infections. Shifting to the other parts of the P&L for 2024 on a non-GAAP basis. There is no change to our gross margin guidance where we continue to expect product gross margin in the range of 85% to 86%. We now expect R&D to grow at the higher end of our previous low to mid-single-digit growth range, reflecting the incremental expenses associated with the CymaBay acquisition. We continue to expect SG&A expenses to decline a mid-single-digit percentage relative to 2023. On a dollar basis, SG&A is expected to be modestly higher than our previous SG&A expectations as we incorporate CymaBay expenses.
However, we can manage this within the window of the previously issued operating expense guidance. Acquired IPR&D is now expected to be approximately $4.4 billion due to the CymaBay transaction, as well as milestones anticipated throughout the rest of the year. Operating income is now expected to be in the range of $7 billion to $7.5 billion, reflecting the updated acquired IPR&D guidance and the modest increase to operating expenses associated with the CymaBay transaction. Given the non-deductible impact of the CymaBay acquisition, the effective tax rate for 2024 is expected to be approximately 30%. This includes a negative impact of approximately 11% from the one-time charge for the acquisition of CymaBay. We therefore now expect eluded EPS in the range of $3.45 to $3.85.
As shown on slide 27, this has only been updated to reflect the transactions that were closed in the first quarter of 2024. Excluding these charges, you can see that we are comfortably within the range of the EPS guidance we shared back in early February. On a GAAP basis, we expect full-year 2024 diluted EPS to be in the range of $0.10 and $0.50. Moving to slide 28, our capital allocation priorities remain unchanged with sufficient flexibility in our balance sheet. Specifically, as demonstrated in the first quarter, we announced a 2.7% increase to our quarterly dividend and returned approximately $1.4 billion to shareholders. In addition, we acquired CymaBay for $4.3 billion, adding seladelpar part to our portfolio. Overall, we'll continue to be disciplined in our use of capital, and while we will continue to be flexible and opportunistic, it is unlikely that Gilead will be engaging in any sizable M&A transactions in the near term.
Before I wrap it up, on slide 29, a quick note on our expectations now that the CymaBay transaction has closed. Pending regulatory approval, we expect to launch seladelpar in the U.S. before the end of 2024, as Johanna highlighted earlier, with a modest revenue contribution expected this year. Additionally, we have shared that the transaction is expected to add to operating expenses this year as we make incremental investments to support the launch, as well as other R&D efforts, all of which we are able to manage within the window of the previously issued operating expense guidance. And as we look ahead, while the transaction will be dilutive to our EPS this year, we expect the deal to be breakeven to earnings in 2025 and significantly accretive in 2026 onwards.
And now I'll invite Rebecca to begin the Q&A.
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