Gilead Sciences - Q2 2023

Transcript

Moderator (participant)

Hello, everyone. Thank you for attending Gilead Sciences' second quarter 2023 earnings conference call. My name is Sierra, and I'll be your moderator today. All lines will be muted during the presentation portion of the call, with an opportunity for questions and answers at the end. If you would like to ask a question, press star one on your telephone keypad. I would now like to pass the conference over to our host, Jacquie Ross, VP of Investor Relations. Please proceed.

Jacquie Ross (VP of Investor Relations)

Thank you, operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the 2Q 2023. 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 the call to Q&A, where the team will be joined by Cindy Peretti, the Executive Vice President of Kite.

Before we get started, let me remind you that we will be making forward-looking statements, including those related to Gilead's business, financial condition and results of operations, plans and expectations with respect to products, product candidates, corporate strategy, business and operations, financial projections and the use of capital, and 2023 financial guidance, all of which involve certain assumptions, risks, and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.

A description of these risks can be found in the earnings press release and our latest SEC disclosure documents. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements. Non-GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non-GAAP reconciliations are provided in the earnings press release in our supplementary data sheet, as well as on the Gilead website. With that, I'll turn the call over to Dan.

Daniel O'Day (Chairman and CEO)

Thank you, Jacquie. Good afternoon, everyone. As always, we appreciate you taking the time to catch up with Gilead in the midst of a busy earnings period. This was another very strong quarter for Gilead in terms of both business performance and clinical execution. Thank you to the Gilead teams that drove this progress with their dedication to improving the health of individuals and communities worldwide.

Total product sales, excluding Veklury, grew 11% year-over-year and closed a very strong first half performance in the base business. As we look to the full year, we are increasing guidance for total product sales. We now expect even stronger growth in our base business of 6.5%-8%, which is expected to more than offset our revised expectations for Veklury.

As a result, our guidance for base business product sales has increased $550 million at the midpoint. In the second quarter, HIV contributed about two-thirds of the $615 million growth in our core business, growing 9% year-over-year. Oncology grew 38% year-over-year, with product sales of $728 million in the second quarter, now has an annual run rate of approximately $3 billion.

Moving to clinical progress, the second quarter was very active on the regulatory front, with approvals, positive opinions, or recommendations for six of our therapies: Trodelvy, Yescarta, Tecartus, Sunlenca, Hepcludex, and Veklury. This regulatory progress highlights the strength of our increasingly diverse portfolio. It also reflects the ability of our teams to successfully navigate regulatory processes across the therapeutic areas and key geographies with speed and efficiency.

In addition to this progress, we shared positive pipeline updates at ASCO, which included overall survival data for Yescarta, the only large B-cell lymphoma cell therapy to demonstrate significant overall survival benefit versus standard of care in the second-line setting, promising Trodelvy data in endometrial cancer, reinforcing our belief in Trodelvy as a cornerstone asset with pan-tumor potential, and updated TIGIT data from the full study population of ARC-7, establishing domvanalimab's proof of concept in lung cancer.

We have also shared long-term data for Hepcludex for hepatitis delta virus, showing improved response rates at week 96 compared to week 48. These data support new guidelines recommending Hepcludex for people living with chronic HDV in the EU. With a broad portfolio of novel mechanisms and a commitment to pursuing areas of high unmet need, we know that some pipeline setbacks are to be expected.

As we announced last month, we have discontinued the phase III ENHANCE study in high-risk MDS due to futility in a second interim analysis. As you know, MDS is one of the most intractable forms of blood cancer. We are disappointed that the study was not able to deliver new hope for patients with the disease.

We will take a thorough, data-driven approach regarding next steps as we carry out the ongoing analysis of magrolimab. Overall, we are executing well on our clinical commitments, and our current performance speaks to the strength of our combined oncology portfolio. We have a rich pipeline of activity in the second half, including an initial look at a subset of EVOKE-02 data on Trodelvy plus pembro in first-line metastatic non-small cell lung cancer.

Before I hand over to Joanna, I'd like to welcome Cindy Peretti, our Head of Cell Therapy, to our first Gilead Earnings Conference Call. Cindy has now been with Gilead for two months and brings a wealth of oncology and leadership experience from Roche, Foundation Medicine, and the Sarah Cannon Research Institute. We're delighted to have Cindy join our Gilead leadership team, and it's great to have her with us on the call today. With that, I'll hand the call over to Joanna for a discussion of our commercial results. Joanna?

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

Thanks, Dan. Good afternoon, everyone. The second quarter was another strong quarter for Gilead, with solid performance across our commercial portfolio, leading to an increase in our full-year expectations for both the base and overall business. For the second quarter of 2023, as shown on slide seven, total product sales, excluding Veklury, grew 11% year-over-year to $6.3 billion, with year-over-year growth in each of our core franchises.

This represents the seventh consecutive quarter of year-over-year growth for our base business, reinforcing the strength of our virology and oncology portfolios. This strong growth more than offset the decline in Veklury sales, which were as expected, given the lower hospitalizations. Altogether, total product sales, including Veklury, was $6.6 billion, up 7% year-over-year.

Starting with HIV on slide eight, second quarter sales of $4.6 billion were up 9% year-over-year, driven by higher average realized price, in part due to channel mix and higher demand, partially offset by lower channel inventory. Quarter-over-quarter, sales were up 10%, driven by favorable pricing and inventory build, following the typical first quarter dynamics.

Overall, the global HIV treatment market continues to grow in line with our expectations of 2%-3% annually. Specifically, in the U.S., the market overall grew more than 2% in the first half of the year compared to the first half of 2022, reflecting growth in the non-retail channels, more than offsetting a roughly flat retail market.

HIV product sales grew 11% in the first half of 2023 compared to the first half of 2022, helped by favorable pricing dynamics, including the phasing of certain government purchases and channel mix. Looking forward, we expect HIV product sales growth to more closely mirror market growth in the second half.

Therefore, we are increasing our full year expectations for HIV and now expect full year HIV product growth for 2023 to be modestly higher than the 5% we reported in 2022. Turning to slide nine, Biktarvy sales of $3 billion were up 17% year-over-year, driven by higher demand and favorable pricing dynamics, partially offset by lower channel inventory. With a market share up almost 3% year-over-year in the U.S., Biktarvy remains the treatment of choice for HIV, with more than 46% market share.

This represents the 20th consecutive quarter of share gains in the U.S., with a year-over-year growth rate that has once again outpaced new and existing regimens. Similarly, we continue to see solid share gains across other major markets as Biktarvy maintains its leading position for new starts, as well as for those switching therapies. Descovy sales were $516 million, up 12% year-over-year.

With awareness and utilization of HIV prevention higher than ever, the U.S. market grew once again, and amidst this growth, we're pleased to see strong demand for Descovy for PrEP, up 14% year-over-year in the U.S., with a strong market share that has remained over 40%. With this strong foundation, we look forward to potentially adding lenacapavir as a six-monthly subcutaneous option for prevention as early as 2025.

Moving to the liver disease portfolio on slide 10, sales were up 4% year-over-year and 5% quarter-over-quarter to $711 million. We remain committed to eliminating HCV globally with our market-leading portfolio of medicines, and our efforts to increase awareness contributed to higher patient starts in the U.S., Europe, and Asia in the second quarter.

HBV and HDV also contributed to growth in the liver disease portfolio, driven by higher demand. Liver disease remains an important part of our portfolio, benefiting hundreds of thousands of patients. We're pleased to have received full marketing authorization for Hepcludex in HDV in Europe, a further recognition of the benefit this medicine brings to patients who have very limited therapeutic options.

Across our portfolio of HCV, HBV, and HDV products, the liver disease contribution to our commercial performance continues to stabilize overall to a run rate of more than $2.5 billion in sales a year. On to slide 11. Veklury sales declined in the second quarter as expected, reflecting lower hospitalization rates with sales of $256 million, down 43% year-over-year.

For those patients hospitalized and treated for COVID-19, a majority continue to receive Veklury, a testament to Veklury's robust clinical profile. This has included decisions by the U.S. FDA and the European Commission to expand Veklury's indication to reach patients with renal impairment, including those on dialysis.

Moving to oncology on slide 12, it is remarkable to observe that in less than five years, our oncology business has grown from less than $300 million and is now approaching an annualized run rate of $3 billion, with tens of thousands of patients treated with Gilead and Kite Oncology therapies to date. Beyond our well-established leadership in cell therapy, we have the only TROP-2 directed ADC on the market with Trodelvy, and combined, our oncology portfolio extends the options for patients in eight indications. Looking in more detail at Trodelvy on slide 13, sales were up 63% year-over-year and 17% sequentially to $260 million, representing an annual run rate that exceeds $1 billion.

We continue to be very pleased with the launch in pretreated HR-positive, HER2-negative metastatic breast cancer, with strong awareness of our approval in the U.S. We look forward to reaching even more patients in Europe following last week's marketing authorization from the European Commission. Additionally, we're beginning discussions with health authorities in Japan, with plans to file for approval in metastatic triple-negative breast cancer later this year.

With a strong field force in place and robust data sets across multiple tumor types, Trodelvy remains well-positioned to maintain and expand its reach. Gilead continues to build on our experience in breast and bladder cancers with a view to other indications over time as the development program evolves. Turning to cell therapy on slide 14, sales in the second quarter were $469 million, up 27% year-over-year and 5% quarter-over-quarter.

Yescarta showed continued growth, with sales up 29% year-over-year to $380 million, primarily driven by strong underlying demand in the 2nd and 3rd-line settings for relapsed or refractory large B-cell lymphoma, both in existing as well as new markets. Tecartus sales were $88 million, up 21% year-over-year, reflecting increased demand for relapsed or refractory adult acute lymphoblastic leukemia, as well as mantle cell lymphoma, primarily outside of the U.S.

We are excited about the opportunity ahead as the body of evidence supporting broader adoption of cell therapies continues to grow. The work that Kite has been leading to raise awareness and adoption of cell therapy will be accelerated by other providers as they ramp up their manufacturing capabilities.

This overall expansion in supply will predictably impact our market share in the near term. Overall, class share is the most important driver of our business over time. As cell therapy is offered and delivered to more patients, we are confident that Kite cell therapies will remain differentiated in terms of our manufacturing, reliability, and efficacy.

Wrapping up the second quarter, I'd like to acknowledge the commercial teams and our partners across Gilead and Kite that once again delivered an extremely strong performance, reflecting both solid execution and the compelling portfolio of Gilead products that positively impacts millions of people around the world. With that, I'll hand the call over to Mehrdad for an update on our pipeline. Mehrdad?

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Thank you, Joanna. I'm pleased to highlight the ongoing progress our teams have made with 64 ongoing clinical programs and 21 phase III trials. Notably, we presented multiple positive data readouts at medical conferences in the second quarter, such as updated overall survival data for Trodelvy in pretreated HR-positive, HER2-negative metastatic breast cancer, OS data for Yescarta in second-line relapsed or refractory large B-cell lymphoma, and long-term data from bulevirtide in HDV.

As we move into the second half of 2023, we remain focused on execution, investing in capabilities to increase our productivity and portfolio prioritization. We also look forward to sharing an update on Trodelvy in non-small cell lung cancer, including EVOKE-02 data at World Conference on Lung Cancer in September. Turning first to virology on slide 16, we're proud of the role Gilead has played in transforming HIV care.

We continue to innovate based on our commitment to both the HIV community and to those who could benefit from a prevention regimen with our ongoing work to deliver new, effective, and convenient options. The unique profile of lenacapavir, our first-in-class capsid inhibitor, enables the 8 prevention and treatment clinical programs we're focused on.

In HIV treatment, the ARTISTRY-1 trial, evaluating an oral once daily bictegravir and lenacapavir combination regimen, is progressing well. We expect to provide an update on the phase II portion of the study later this year. This novel regimen aims to provide an effective and simpler regimen for the 6%-8% of virologically suppressed individuals who are currently on complex multi-tablet regimens to manage their HIV.

We continue to advance in our goal of providing longer-acting HIV treatment options through the development of lenacapavir combination regimens with integrase inhibitors, NRTIs, and NNRTI, as well as the phase two study of our two broadly neutralizing antibodies. In HIV prevention, recruitment for our phase three PURPOSE one and two clinical trials, evaluating every six months, single agent subcutaneous lenacapavir continues to exceed our expectations in the second quarter.

We look forward to potentially providing a data update in the late 2024 to early 2025 timeframe as we target approval in late 2025. Moving on to slide 17. I'm pleased to note that the European Association for the Study of the Liver, or EASL, has updated its HDV guidelines to recommend that all patients in the EU with chronic HDV infection should be considered for antiviral treatment.

Recently, Hepcludex was granted full approval by the European Commission and remains the only approved therapy for chronic HDV infection in the EU. The updated guidelines were supported by Hepcludex's 48-week data, which were published in The New England Journal of Medicine in June. Gilead also presented data demonstrating that 96-week treatment with bulevirtide improved virologic and biochemical responses with no evidence of treatment-emergent resistance, including in those who were previously non or partial responders.

These data reinforce our confidence in bulevirtide and its potentially longer-term benefit for patients with HDV. As a reminder, bulevirtide is not yet approved in the U.S. Turning to oncology on slide 18, Trodelvy remains the first and only approved TROP-2-directed ADC, with indications across three tumor types. It's also the only TROP-2-directed ADC to show overall survival benefit versus chemotherapy in two tumor types.

We've now treated over 20,000 patients and evaluated more than 2,300 patients in our clinical trials. TRODELVY's robust dataset informs a well-characterized safety profile with low discontinuation rates observed across multiple indications and no required increasing monitoring for severe interstitial lung disease. At ASCO, we presented additional data demonstrating TRODELVY's potential, including in pretreated HR-positive, HER2-negative metastatic breast cancer.

We presented the final analysis from our phase three TROPiCS-02 trial, supporting the marketing authorization we just received from the European Commission last week. In bladder cancer, we shared an analysis of TROPHY-U-01, supporting TRODELVY's efficacy in post-platinum, post-IO metastatic urothelial cancer across a range of TROP-2 expression. With our accelerated approval in bladder cancer, we hope to provide a data update from the ongoing confirmatory phase three TROPiCS-04 trial and initiate global filings for TRODELVY in metastatic urothelial cancer by the end of next year.

In heavily pretreated endometrial cancer, we presented promising efficacy data from our phase two TROPiCS-03 basket trial, demonstrating the expanding pan-tumor potential of Trodelvy. Moving to slide 19, our comprehensive clinical development program in non-small cell lung cancer includes several signal-seeking and ongoing phase three clinical trials.

We know non-small cell lung cancer is not only an area of significant unmet need as a number one cause of cancer-related deaths, but also an area we believe Trodelvy has the potential to transform standard of care as a combination partner to an IO backbone in the first-line setting, as well as a single agent in the post-IO setting. On slide 20, we highlight the growing number of lung-related catalysts. I'm particularly excited to highlight that we've added a new milestone with a preliminary readout from our phase two EVOKE-02 trial at the World Conference on Lung Cancer.

This study is evaluating TRODELVY plus pembrolizumab with or without chemo in first-line non-small cell lung cancer. We'll be sharing data from the first two cohorts evaluating TRODELVY in combination with pembro in PDL1 high and PDL1 low patients. The abstract, expected to be released later in August, will be an initial subset of a small number of patients.

Our presentation, scheduled for Sunday, September tenth, at World Lung, will include data at a later cutoff date with more patients. Turning to domvanalimab, or DOM, on slide 21, we presented data from the last interim analysis of the full 150 patients enrolled in the Phase II ARC-7 study at ASCO in June.

The data continue to show consistent and clinically meaningful improvement in progression-free survival in first-line PDL1 high non-small cell lung cancer when DOM, or Fc-silent anti-TIGIT, is combined with an investigational anti-PD-1 agent as compared to the PD-1 inhibitor alone.

These data form the basis for our DOM program, encompassing phase III trials in first-line non-small cell lung cancer and upper GI cancers. Moving to cell therapy on slide 22, Yescarta continues to strengthen its position as a cell therapy of choice for large B-cell lymphoma. At ASCO in June, we presented overall survival data from a landmark phase III ZUMA-7 trial of Yescarta in second-line relapsed or refractory large B-cell lymphoma.

At a median follow-up of four years, a one-time treatment with Yescarta demonstrated a statistically significant longer overall survival compared to standard of care, with a 27% reduction in risk of death, representing a 38% relative improvement. Moreover, majority of the patients in the standard of care arm eventually received a cell therapy off protocol, and of those, 77% received Yescarta. Overall, Yescarta is the first treatment in nearly 30 years to demonstrate a significant improvement in survival for this patient population, and these data add to the growing body of evidence that position cell therapy is potentially curative in some populations.

With a strong pipeline of six ongoing phase two and three trials across lines of therapy, new tumor types, and earlier-stage assets, Kite continues to innovate and execute on expanding the potential benefit of cell therapies to new patients, both through internal or acquired innovation and through collaborations. We're working closely with one of these partners, Arcellx, to support their efforts regarding the IMAGINE-1 clinical hold.

We remain confident in the therapeutic profile for CART-ddBCMA and the IMAGINE-1 trial, based on the data demonstrated to date, and share in Arcellx's commitment to delivering this novel therapy to multiple myeloma patients. Turning to slide 23, we highlight our progress against key clinical milestones for 2023 so far. We are, of course, disappointed by the outcome of the interim analysis of the ENHANCE trial, evaluating magrolimab in higher risk MDS, given the need for treatment options.

We will continue to monitor and report on the other magrolimab trials. Importantly, while not every trial will be positive, our efforts at building a well-diversified portfolio gives us multiple opportunities to improve the lives of patients. We're excited about our momentum in making oncology and inflammation important contributors to our future and continue to make strong progress on delivering our key clinical catalysts for this year.

Beyond our near-term milestones, I'd also like to highlight our growing pipeline of early-stage inflammation assets, including our oral alpha four beta seven and the progression of our IRAK4 inhibitor, adedaserinib, into phase two, as well as the advancement of the BTLA agonist program from the MiroBio acquisition into phase on.

We're excited by this differentiated inflammation pipeline and the potential to impact important gaps in the treatment of inflammatory diseases. Overall, we believe we have a very ambitious clinical portfolio that is well-diversified across indication and stage. We look forward to updating you as we progress through 2023. With that, I'll hand the call over to Andy. Andy?

Andrew Dickinson (CFO)

Thank you, Mehrdad. Good afternoon, everyone. Turning to slide 25, and as you heard from Dan and Joanna, our base business continued to perform very well in the second quarter, with total product sales excluding Veklury, up 11% year-over-year, driven by growth across all of our product families. FX was still a headwind, albeit more modest, impacting growth by approximately one percentage point.

Total product sales were $6.6 billion, up 7% year-over-year, as strong execution in our base business more than offset the lower Veklury sales, as well as FX impact of $82 million. Moving to the rest of the P&L on a non-GAAP basis on Slide 26. Product growth margin was 86.9%, up 131 basis points from last year.

R&D was $1.4 billion, up 25% year-over-year, due to higher expenses associated with our broad clinical pipeline, including the acceleration of certain late-stage clinical studies. As a reminder, we have 21 ongoing Phase III trials, highlighting the investment we continue to make in Gilead's near and long-term growth profile.

As mentioned earlier this year, we will continue to manage expenses carefully. In R&D, with the number of significant mid to late-stage trials ongoing, we'll continue to follow the science, pivoting investment if and when the data warrants. Acquired IPR&D was $236 million, reflecting the Xinthera acquisition and expansion of the Arcus collaboration into inflammation, in addition to milestone payments associated with ongoing partnerships.

SG&A was $1.8 billion, up 45% year-over-year, including the $525 million legal accrual for settlements with certain plaintiffs in the HIV antitrust litigation, as well as increased commercial activities in oncology and HIV. Excluding the legal settlement accrual, non-GAAP SG&A expense was $1.3 billion, up 4% year-over-year.

Moving to tax, our effective tax rate in the second quarter was 21%. Our non-GAAP diluted earnings per share was $1.34 in the second quarter of 2023, including approximately $0.32 of expense associated with the legal settlement accrual, partially offset by higher product sales. This compared to $1.58 of earnings for the same period last year.

Overall, we had a very strong first half, as highlighted on slide 27, with solid performance in each of our core franchises across virology and oncology, driving 13% year-over-year growth, excluding Veklury. Given these strong first half results, we have updated our full year sales guidance. Moving to slide 28. We now expect total product sales in the range of $26.3 billion-$26.7 billion, up from $26 billion-$26.5 billion previously.

We expect total product sales excluding Veklury in the range of $24.6 billion-$25 billion, up from $24 billion-$24.5 billion previously. This new range represents growth of 6.5%-8% for our base business year-over-year, compared to 4%-6% previously. On Veklury, the second quarter and first half were below our internal expectations.

Based on COVID-19 infections and hospitalizations to date, we have lowered our guidance for the full year to approximately $1.7 billion to bring second half expectations more in line with our first half experience. As a reminder, Veklury is highly correlated with COVID-related hospitalizations, and as such, its utilization remains variable. We will share another update with you on our third quarter call. Moving to the rest of the P&L.

We continue to expect non-GAAP gross margin to be approximately 86%. There is also no change to our non-GAAP R&D guidance, where we expect expenses to increase by a low double-digit % compared to 2022. Reflecting the one-time legal settlement accrual of $525 million in the second quarter, we now expect non-GAAP SG&A expense to increase a high single-digit % compared to 2022.

Excluding this legal settlement accrual, non-GAAP SG&A expense for 2023 is expected to be down a low single-digit % compared to 2022, consistent with our prior guidance. Non-GAAP acquired IP R&D has been updated to reflect the Xinthera acquisition and expanded Arcus collaboration, adding about $200 million or $0.17 per share.

For 2023, we now expect acquired IP R&D to be approximately $900 million, reflecting previously committed acquired IP R&D amounts, as well as known milestone payments from existing collaborations. Similar to prior quarters, we will continue to include expected acquired IP R&D expenses if we announce additional transactions over the course of the year.

We now expect non-GAAP operating income in the range of $10.4 billion-$10.9 billion, or roughly $650 million lower at the midpoint, due to the $525 million one-time legal settlement accrual and $200 million in additional acquired IP R&D expense, neither of which were reflected in our previous full year guidance. Moving to tax, we now expect our non-GAAP effective tax rate to be approximately 17%, reflecting an expected decrease in our tax reserves for the second half of the year. Altogether, we now expect non-GAAP diluted EPS in the range of $6.45 and $6.80 per share, down from $6.60 and $7 previously, as shown on slide 29.

The chart illustrates the underlying strength of our business, with the higher product sales guidance flowing through to the bottom line, in addition to lower expected tax rate. This is, however, offset by both acquired IP R&D at $0.17 per share and the legal settlement accrual at $0.32 per share, a non-recurring cost. On a GAAP basis, we expect diluted EPS to be in the range of $4.50 and $4.85.

Moving to slide 30, you can see that there is no change to our capital allocation priorities. We returned $1.1 billion to shareholders in the second quarter through our dividend and repurchase of shares. We believe we have built a strong pipeline that will enable Gilead to deliver near and long-term growth.

Of course, we'll continue to remain opportunistic as we look to access high-quality assets through partnerships or make smaller acquisitions in the normal course of business. We remain committed to growing our dividend and to using share repurchases primarily to offset equity dilution, although we will also be opportunistic from time to time. With that, I'll invite the operator to open the Q&A.

Operator (participant)

If you would like to ask a question, please press star followed by one on your telephone keypad. To remove your question, press star followed by two. In addition, we will only be allowing one question from each analyst today, and if you are using a speakerphone, please remember to pick up your handset before asking a question. Our first question comes from Geoff Meacham with Bank of America. Please proceed.

Geoff Meacham (Equity Research Analyst)

Hey, guys, thanks so much for the question. Just maybe a quick one for for for Dan or or for Andy. You guys have had an aspiration to, you know, to have about a third of total revenue from hematology oncology. I wasn't sure how big of a role magrolimab played in those assumptions, and, and, and if it was a small amount, you know, where do you see opportunities in the pipeline that you think the street perhaps is underappreciating? Thank you very much.

Daniel O'Day (Chairman and CEO)

Hey, Geoff, I'll start and then turn it over to Andy. Thank you very much for the question. I, I wanna be clear that we continue to be on track to meet our goal of oncology, representing 1/3 of our 2030 revenues, and that's on top of a, of a growing HIV business overall. I'll, I'll just remind the team here that, you know, our portfolio is very broad.

It's more than doubled since a few years ago in quantity and, and manyfold on a quality risk-adjusted basis as well. We have novel mechanisms and technologies and approaches across many indications, precisely to allow for the fact that not every clinical card is going to turn over favorably. Andy, I'll let you add on to that in terms of what we, you know, what our initial assumptions were around the third.

Andrew Dickinson (CFO)

Sure. Hi, hi, Jeff. I'm good to hear from you, and thank you for the question. You may recall that historically, when we've talked about this, we've highlighted that that assumption is really tied to the cell therapy business and to Trodelvy, and that we have a complete belief that we're gonna get there based on those two franchises alone. Magrolimab and TIGIT and the rest of the oncology pipeline provide additional upside.

Just reiterating what Dan said, we continue to be on track to meet the goal of our oncology business, representing a third of our total revenue by 2030, and we remain excited about the breadth of our oncology portfolio and the exceptional progress that you see in cell therapy and Trodelvy, which combined, as you heard in the prepared remarks, are on track to produce $3 billion of revenue, roughly this year.

Operator (participant)

CR, may we have our next question? Our next question comes from Chris Schott with J.P. Morgan. Please proceed.

Chris Schott (Managing Director and Senior Equity Research Analyst)

On Trodelvy and the EVOKE-02 data, can you just help set some expectations for the profile that we'll see from that at World Lung? I guess specifically, we'd just be interested in your thoughts on what we should anticipate in terms of the ILD profile in this setting, as well as your thoughts on potential TROP-2 expression biomarker-driven approach that I think your competitor has alluded to post their data. Thanks so much.

Daniel O'Day (Chairman and CEO)

Thanks, Chris. Over to Merdad, please.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Yeah, we're looking forward to sharing those data, and as you can imagine, we're under embargo, so I, I can't share too many details until the presentation comes up. The abstract itself will, will come out, I, I think in mid-August, so very shortly. That initial abstract will represent a, a relatively small data set from EVOKE-02, and then there'll be more data at the time of the presentation in September.

In terms of what, what's coming. In terms of ILD, across our, our programs, including all the clinical trials, we have not seen ILD to date. We don't screen for ILD in our clinical trials, nor in the clinical practice. At this time, we have not seen anything from an ILD standpoint.

In terms of Trop-2 expression, you know, as a matter of course, we are measuring Trop-2 expression in all of our trials as we go forward and looking to see if we see correlations between Trop-2 expression and efficacy. To date, we've not seen a correlation. We've seen great efficacy across Trop-2 expression levels in the tumors that we've studied to date.

That may change with different tumor types, but to date, we have not seen a correlation with Trop-2 expression levels. We're optimistic for that to keep to continue. I would not expect to see Trop-2 data in this upcoming data set. This is an early data set, and those data usually trail the Trop-2 expression data usually trail the clinical trials.

Moderator (participant)

Thank you. May we have our next question, please?

Operator (participant)

Our next question comes from Tyler Van Buren with TD Cowen. Please proceed.

Tyler Van Buren (Managing Director and Senior Equity Research Analyst)

Hey, guys. Good afternoon. Thanks for taking the question. Another one on Trodelvy. It looks like we're seeing a bit of a quarter-over-quarter inflection, would you say this is attributed primarily to the HR-positive, HER2-negative launch? Do you believe this is the beginning of a new sustainable trend?

Daniel O'Day (Chairman and CEO)

Great, Tyler. Yeah, over to Joanna, please.

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

Hi, Tyler. Yeah, we're very pleased with the results and the early signs that we've seen from the recent launch of HR-positive, HER2-negative in the US. We've definitely seen, as you say, an inflection point, so we've seen a really strong uptake in this setting. We've also kind of building on the foundation of triple-negative breast cancer, where we are the standard of care here as well, and we're excited about the fact that Europe, the EC, just gave approval for HR-positive, HER2-negative in Europe.

Building on the success of TNBC, and we've seen strong uptake in Europe for TNBC, so there's also a piece of that for the Trodelvy business performance. And we're excited to see what we can do with HR-positive, HER2-negative in Europe as well. We do think this is, definitely on the right path from a growth standpoint, and, very exciting times for Trodelvy and breast cancer patients.

Moderator (participant)

Thank you. Sierra, may we have our next question, please?

Operator (participant)

Our next question comes from Terence Flynn with Morgan Stanley. Please proceed.

Terence Flynn (Managing Director and Head of U.S. Biopharma Research)

Hi. Thanks so much for taking the question. This one's for Joanna. I read that there's a CMS could propose to have Medicare cover PrEP. Just wondering, if you have any insight on the likelihood here and timing, and then could you help us think about the size of that population? Thank you.

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

Yeah. Thanks for the question. I think you're referring to the National Coverage Determination, the NCD, right, for prevention, for PrEP? Yes. I'm assuming. That's really just because it's the. Right now, it currently only supports oral drugs, and there's an opportunity for us to add injectable drugs, and I think that was a V request to CMS. We're very supportive, of course. We believe PrEP is actually quite central to ending HIV epidemic and fully support the CMS proposal.

As from a timing standpoint, that's probably, hopefully, in the coming quarters that we should see something come out, but I don't have details on that. I do think it can only help what we're trying to do in HIV prevention, let alone support, as we, we think of launching the potential launch for lenacapavir in 2025.

Moderator (participant)

Thank you. May we have our next question, please?

Operator (participant)

Our next question comes from Robin Karnauskas with Truist. Please proceed.

Billal Jahangiri (Research Analyst)

Hi, this is Bilal Jahangiri on for Robin. Thanks for taking our question, and congrats on all the progress. I had a question about TIGIT. Since you began the ARC Studies, have you learned anything by way of expression of TIGIT, CD155, or any other potential prognostic biomarkers in the tumor microenvironment that would warrant further development of dom in the upper GI indications, even if SKYSCRAPER-01 were to fail?

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Thanks for the question. As I understand it, I think the question is around predictors of response as it relates to the upper GI setting. What I would say is we, we, of course, are following biomarkers. As I mentioned, with TROP-2, we are looking for biomarkers of responsiveness to various markers that could predict TIGIT responsiveness.

Our, our interest in the upper GI is of course, based on TIGIT expression levels in tumor samples and things like that outside of the clinical trials, but more based on clinical data that, that we've seen and others have seen for the efficacy of TIGIT in upper GI tumors. We'll, of course, across the programs, be looking for any potential markers for predictive response.

Moderator (participant)

Thank you. May we have our next question, please?

Operator (participant)

Our next question comes from Brian Abrams with RBC Capital Markets. Please proceed.

Brian Abrams (Managing Director and Co-Head of Biotechnology Research)

Hi there. Thanks for taking my question, and congrats on the quarter. Maybe a question on magrolimab. Do you have any preliminary thoughts on, you know, why the trial in high-risk MDS was not successful, just given the encouraging early data? I guess, which indications are you most optimistic the drug could still be successful in going forward? Thanks.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Thanks, Brian. Well, I mean, I think, you can imagine we are looking thoroughly at the data, and the trigger for this was a futility analysis centered on overall survival. We'll of course, update as we generate data, and look at all those. We'll, we'll make those that information publicly available. To your point, the, we're fairly far along in our AML trials, and as you know, we have some studies going on in solid tumors, and we believe that there are a number of factors that could that determine success or failure in these various settings. Each of these settings, it represents a slightly different biological experiment.

We are gonna continue to look broadly at what, you know, what we've learned from the initial data. We're gonna continue to talk with the regulators and the IRBs in the near term, and then we'll update you as we proceed down that path with where we're gonna go. We continue our efforts right now, hoping that magrolimab could have an effect in other diseases outside of MDS. MDS is a uniquely challenging indication, and we feel, you know, we were hoping we could bring a benefit to those patients, and we're disappointed that we can't do that.

Moderator (participant)

May we have our next question, please?

Operator (participant)

Our next question comes from Carter Gould with Barclays. Please proceed.

Carter Gould (Senior Analyst)

Great. Good afternoon. Thank you for taking the question. As you talked about sort of the hematology portfolio, one thing you guys didn't talk on much today is sort of the ddBCMA and it being on clinical hold. Your partner has talked about investigator conduct and bridging therapy being issues. Are you sort of in agreement with that characterization? To what extent is sort of, you know, timely addressing of the clinical hold critical to your underlying thesis behind the product? Thank you.

Daniel O'Day (Chairman and CEO)

Thanks, Carter. This gives us a chance... Well, all a chance to hear from Cindy for the first time with Gilead. Cindy, over to you, please.

Cindy Peretti (EVP)

Thanks a lot, Carter, for the question. I think first it might be helpful if I can provide a little context associated with the clinical hold. On June 16th, the FDA did notify Arcellx that it was placing the CAR T ddBCMA IND on clinical hold, and that was following a patient death. The patient was treated with the ddBCMA, our, our CAR T, and despite becoming ineligible for treatment under the trial protocol, due to the fact that they developed a secondary malignancy, before the time of infusion, so they would have not, been allowed technically to be on protocol. After infusing that patient, they subsequently, mismanaged, I would say, the manner in which the protocol specifies treatment of adverse events. So we are continuing to partner with Arcellx on this.

We are very confident in the molecule, we're confident in the iMMagine-1 study design, and we're looking at ways in which we can partner with Arcellx to enhance protocol adherence. All of the clinical sites to date have been retrained so that we can again ensure that protocol adherence. Additionally, the FDA has allowed Arcellx to dose patients who had gone through lymphodepletion while on clinical hold.

Again, we remain confident that the therapeutic profile of ddBCMA CAR T and the iMMagine-1 trial, is going to be successful, I think, based on the data demonstrated to date. Our commitment in delivering that therapy to patients globally is still there for multiple myeloma.

Moderator (participant)

Thank you. Sierra, may we have our next question, please?

Operator (participant)

Our next question comes from Salveen Richter with Goldman Sachs. Please proceed.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

are expected to share the model.

Operator (participant)

Salveen, we're not, we're not hearing you very well. Maybe just try, try one more time.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

After,

Operator (participant)

Salveen, maybe you can try and dial in on a different line. Salveen, are you still there?

Speaker 20

This is Matt on for. Hey, Jackie, can you hear me? This is Matt on for Salveen.

Operator (participant)

Yes, we can hear you perfectly.

Speaker 20

Okay, great. Daiichi expects to share full data on the phase three TROPION-Lung01 study later this year. Could you guys just share what you're focused on from a competitive standpoint, and then in terms of read-through to Trodelvy? Thank you.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Sure. This is Merdad. Thanks for the question. As you know, our program is relatively broad and pushing forward in lung cancer as well. As I mentioned earlier, we'll be presenting our frontline data in EVOKE-02, preliminary frontline data from the EVOKE-02 study. I think that, that will help provide everyone benchmarking in terms of how Trodelvy is doing in that setting. Then what we'll be looking for, I think, is consistent with what our belief is for Trodelvy in the second line, which is, look, the patients in second line are sicker. They tend to have, they're more difficult to manage and they're more challenging in terms of outcomes.

You know, we, we are hopeful that we will see a benefit in those patients in terms of outcomes, particularly PFS and OS. You know, we, we, we will keep ourselves, you know, keep you updated on the progress of the EVOKE-01 study in the second line as well. We're, we're pretty confident that we'll be, you know, in where we wanna be. Our underlying hypothesis remains that we will have comparable efficacy and that we will have a better tolerability profile with Trodelvy. We're, we're very confident with, with where we're headed.

Moderator (participant)

Thank you. Sierra, may we have our next question, please?

Operator (participant)

Our next question comes from Colin Bristow with UBS. Please proceed.

Colin Bristow (Managing Director and Biotechnology Equity Research)

Hey, good afternoon, and congrats on the quarter. The TROPION-Breast01 is expected to read out in the near term. I'm just curious to get your thoughts really on how you view this from a sort of competitive threat standpoint. Thank you.

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

I, I think we may just have answered that question.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

It was breast.

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

Oh, in breast.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Sorry, for Breast one.

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

Maybe I'll pick it up.

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Yeah. Joanna, you want to-

Johanna Mercier (Chief Commercial and Corporate Affairs Officer)

So thanks for the question, Colin. We have been expecting that data. We're also very pleased with what we've seen thus far with Trodelvy, and I think that's the piece that's important here. I think Trodelvy's positioning in the marketplace, both in metastatic triple-negative breast cancer and second-line as the standard of care in that setting, is very well established with an opportunity to continue to make sure people move up lines of therapy because there's still usage in the third, fourth-line setting when, you know, there's still an opportunity to displace chemotherapies. I think as we've seen with other ADCs in the breast cancer market, I think it's really helped the awareness of the benefits of ADCs.

With Trodelvy's overall survival, both in triple-negative breast cancer as well as in, HR-positive, HER2-negative, I, I do think it sets up Trodelvy incredibly well. We've seen also ADC sequencing, either from Enhertu to Trodelvy or Trodelvy to Enhertu.

I think as a third ADC comes to market, I think it might be a little bit more challenging in light of some of the positioning that's already there, but I do think for patients, this is a great thing. I also think the safety profile that Merdad mentioned just a little bit earlier is also something to consider when you think about a safety profile with Trodelvy, where, you know, you're looking at neutropenia and diarrhea, which are very much in line with other chemotherapies already on the marketplace.

Physicians are very confident in how to treat versus bringing in something like ILD is gonna be a little bit more concerning. More to come, and I guess we wait to see the data. Today, in the field today, I think Trodelvy is definitely making a difference for these patients. Merdad, did you want to add anything?

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

No, I think you hit it all.

Moderator (participant)

Thank you, Joanna. Sierra, may we have our next question, please?

Operator (participant)

Our next question comes from Evan Seigerman with BMO Capital Markets. Please proceed.

Evan Seigerman (Managing Director and Head of Healthcare Research)

Hi, all. Thank you, thank you so much for taking my question. With, I believe it's the third anniversary of the Immunomedics deal nearing us, can you walk us through how you look, you know, look forward to BD?

Merdad Parsey (Chief Medical Officer and EVP, Research and Development)

Sure.

Evan Seigerman (Managing Director and Head of Healthcare Research)

You've digested this asset. Are you looking at oncology, inflammation elsewhere? Thank you.

Daniel O'Day (Chairman and CEO)

Yeah. Andy, do you wanna start with this?

Andrew Dickinson (CFO)

Sure. Hi, Evan, thank you for the question. look, I'd say, we continue to be very active in BD, as you'd expect, across both Gilead and Kite, and that's across all of our areas of focus. Again, oncology, inflammation, and virology. As we've said before, there are fewer virology opportunities externally. We have an incredibly robust pipeline and extraordinary research group.

We're building out our research groups at Kite and at Gilead, in oncology and inflammation. We're excited about the progress that we're making there. We're still gonna be active in the outside. That being said, what you should expect over the next five years is different than what you saw over the last five years. Using Immunomedics as an example, that's a deal that we continue to be very excited about.

You've heard all the excitement about Trodelvy and where we are today with the franchise, where we see it going. That was a unique point in time where we really needed an anchor molecule to build our oncology business around. We will continue to look at commercial assets, but you should expect, consistent with what you saw last year, that our focus is predominantly on ordinary course partnerships and smaller acquisitions. Again, we will be opportunistic. We will look for ways to build our franchise and to create value for shareholders, but that's the base case expectation.

Moderator (participant)

Thank you. May we have our next question, Sierra?

Operator (participant)

Our next question comes from Joe Catanzaro with Piper Sandler. Please proceed.

Joe Catanzaro (Director and Senior Biotech Equity Analyst)

Hi, everybody. Thanks so much for taking my question. I actually had a question on the Xinthera acquisition, and just wondering if you could share your thoughts around the plans and timelines for their PARP-1 selective inhibitor, and whether in the future there's opportunity to potentially combine it with Trodelvy, given some preclinical data that supports that, that approach? Thanks.

Daniel O'Day (Chairman and CEO)

Yeah, that's, I think you hit the nail on the head. We're, we're moving forward aggressively. Not sure we've disclosed the timelines yet, but we're moving forward aggressively with our efforts to move that program into the clinic. As you say, I think a key potential for the- that PARP inhibitor is in combination with Trodelvy and, and combining those two agents to hopefully bring better outcomes to patients. We'll, we'll, we'll update as we go along. I think things are, things are progressing very nicely there, though.

Moderator (participant)

Sierra, our next question, please.

Operator (participant)

Our next question comes from Mohit Bansal with Wells Fargo. Please proceed.

Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)

Great. Thank you very much for taking my question, welcome, and congrats, Cindy, on your new role. Maybe if I can ask a question to Andy, regarding-

Andrew Dickinson (CFO)

Okay.

Mohit Bansal (Managing Director and Co-Head of Therapeutics Research)

You have a lot of clinical trials going on in oncology, especially. How should we think about the operating margin evaluation from here? If I take out the one-time items as well as IP R&D, it seems like about 45% in the first half of the year. Is that a good number, good proxy to go with? Or how should we think about it in next few years?

Andrew Dickinson (CFO)

Hi, Mohit. Thanks, thanks for the question. This is an important, an important point. You know, what we've said and, and we continue to believe, is we have an exceptionally strong business with a lot of leverage, a highly efficient structure, a lot of leverage in our model. We've historically had industry-leading operating margins, and we certainly expect to have that in the future.

We're also have said and, and acknowledge that we're at a unique point in time as we've built out both our R&D portfolio and our sales and marketing team with the, the move into oncology, where our expenses have increased in the short run, and we expect over the coming years for the expense, the expense increases to moderate, and we expect that you'll continue to see the strong growth that you've seen in our base business the last couple of years.

You know, again, this is kind of our strategy playing out, where you see the extraordinary progress in the base business growth last year, certainly through this year. You see that with the raised guidance for the base business. We expect to carry that momentum going forward. Of course, we don't provide long-term guidance.

We, as we've highlighted, have 21 late-stage phase three clinical studies underway. We will get to a point over the coming quarters and years where our expense growth moderates, and you should see a lot of that carry to the bottom line. I think the way that you characterize the operating margin in the second quarter is entirely consistent with the way that I see it. We don't provide long-term guidance beyond saying that we expect to have a top-tier operating margin, going forward, and we think we're in a great place to achieve that goal. Thank you.

Moderator (participant)

Thank you. I think we have time for one last question, Sierra.

Operator (participant)

Our last question today comes from Simon Baker with Redburn. Please proceed.

Simon Baker (Partner and the Head of Global Biopharma Research)

Thanks for taking my question. Given the recent developments within the CAR T space in non-oncology indications such as lupus, I was just interested to know what your perspectives are on the strategic, clinical, and commercial opportunities for cell therapy outside oncology. Thanks so much.

Cindy Peretti (EVP)

Thank you very much for the question, Simon. Similar to you, we are very intrigued also by the data that we're seeing in spaces like autoimmune disease and lupus, and it's something of great interest to us. We have established ourselves in oncology, certainly, and expanded into multiple myeloma with the Arcellx collaboration, and we are also looking at autoimmune disease going forward.

Daniel O'Day (Chairman and CEO)

Terrific. This is Dan. I just want to close this call by thanking you all for joining, and maybe just relay some of the enthusiasm of both the team here in the room and the colleagues throughout Gilead and Kite. You know, we're really seeing continued positive momentum, and this is just another quarter of that related to our strategy that we set out several years ago. I mean, the first thing is the business is performing well and on a consistent basis.

This is our seventh consecutive quarter of year-on-year growth for our business, excluding Veklury. Secondly, you know, we're much further ahead than we expected to be with our pipeline delivery. We have now 64 ongoing clinical programs, 21 in phase III. You saw that in the news flow for the second quarter.

Then finally, we have a lot to look forward to in the second half of the year and beyond. We're particularly excited about the potential to transform beyond the diseases that we're helping patients with today in lung cancer and continuing to help the epidemic for HIV and, and the epidemic for HIV. I just want to take this opportunity on behalf of all of us to thank you for joining.

As usual, if you have questions that we haven't been able to handle here today, please get in touch with Jackie and the IR team, and we're more than happy to support you. Thank you, everybody, and thanks for joining today.

Operator (participant)

That will conclude today's conference call. Thank you all for your participation. You may now disconnect your line. Goodbye.