Hello, everyone. Thank you for attending Gilead Sciences' Second Quarter 2023 Earnings Conference Call. My name is Sarah 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.
[Operator Instructions] I would now like to pass the conference over to our host, Jacquie Ross, VP of Investor Relations. Please proceed..
Thank you, operator, and good afternoon, everyone. Just after market close today, we issued a press release with earnings results for the second quarter of 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 Perettie, 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 supplemental data sheet, as well as on the Gilead website. With that I'll turn the call over to Dan..
Thank you, Jacquie, and 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% to 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 mid-point.
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, and 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, an 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 3 ENHANCE study in Higher-Risk MDS due to futility and a second interim analysis.
As you know, MDS is one of the most intractable forms of blood cancer and 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 were 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 Johanna, I'd like to welcome Cindy Perettie, our Head of Cell Therapy to her 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 Johanna for a discussion of our commercial results.
Johanna?.
Thanks, Dan, and 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. The 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% to 3% annually.
Specifically in the US, 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 US, 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 US, with the 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 US 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 US, 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 US, 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 continued to receive Veklury, a testament to Veklury's robust clinical profile.
Most recently, this has included decisions by the US-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 TROP2-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 pre-treated HR+/HER2- metastatic breast cancer, with strong awareness of our approval in US.
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 datasets across multiple tumor types, Trodelvy remains well-positioned to maintain and expand its reach, and 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 second and third-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 the US. 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 in the 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, but 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 a compelling portfolio of Gilead products that positively impacts millions of people around the world.
And with that, I'll hand the call over to Merdad for an update on our pipeline.
Merdad?.
Thank you, Joanna. I'm pleased to highlight the ongoing progress our teams have made with 64 ongoing clinical programs and 21 Phase 3 trails.
Notably, we presented multiple positive data readouts at medical conferences in the second quarter, such as updated overall survival data for Trodelvy in pre-treated HR+/HER2- metastatic breast cancer, OS data for Yescarta in second-line relapsed or refractory large B-cell lymphoma, and long-term data from blabber tied 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 are 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 prevention regimen with our ongoing work to do over new effective and convenient options.
The unique profile of lenacapavir, our first-in class capsid inhibitor enables the eight prevention and treatment clinical programs, we're focused on. In HIV treatment the ARTISTRY-1 trial evaluating oral once daily bictegravir and lenacapavir your combination regimen. It's progressing well.
We expect to provide an update on the Phase 2 portion of the study later this year. This novel regimen aims to provide an effective and simpler regimen for the 6% to 8% a biologically 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 2 study of our two broadly neutralizing antibodies.
In HIV prevention, recruitment for our Phase 3 PURPOSE-1/-2 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 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 treatments.
Recently Hepcludex was granted full approval by the European commission remains the only approved therapy for chronic HCV 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 the 96-week treatment with bulevirtide improved biologic and biochemical responses with no evidence of treatment-emergent resistance, including 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 US. Turning to Oncology on slide 18. Trodelvy remains the first and only approved TROP2-directed ADC with indications across three tumor types. It's also the only TROP2-directed ADC to show overall survival benefit versus chemotherapy in two tumor types.
We've now treated over 20,000 patients and evaluate more than 2300 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 pre-treated HR+/HER2- metastatic breast cancer. We presented the final analysis from our Phase 3 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 3 TROPiCS-04 trail and initiate global filings for Trodelvy in metastatic urothelial cancer by the end of next year.
In heavily pre-treated endometrial cancer, we presented promising efficacy data from our Phase 2 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 3 clinical trials.
We know non-small cell lung cancer is not only an area of significant unmet need, as the number-one cause of cancer-related death, 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 2 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 will be sharing data from the first two cohorts evaluating Trodelvy in combination with pembro in PD-L1 high and PD-L1 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 10th at World Lung will include data at a later cut-off 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 2 ARC-7 study at ASCO in June.
The data continued to show consistent and clinically meaningful improvement in progression-free survival in first-line PD-L1 high non-small cell lung cancer, when dom, our Fc-silent anti-TIGIT is combined with an investigational anti-PD1 agent as compared to the PD1 inhibitor alone.
These data form the basis for our dom program encompassing Phase 3 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 the landmark Phase 3 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, the 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 as potentially curative in some populations.
With a strong pipeline of six ongoing Phase 2 and 3 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 are 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 CAR-T ddBCMA and IMAGINE-1 trial based on the data demonstrated to date, and sharing 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 4 beta 7 and the progression of our IRAK4 inhibitor that had asserted into Phase 2, as well as the advancement of the BTLA agonist program from the MiroBio acquisition into Phase 1.
We are 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 indications and stage. We look forward to updating you as we progress through 2023.
With that I'll hand the call over to Andy.
Andy?.
Thank you, Merdad, and 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 gross 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 3 trials, highlighting the investments 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.
And in R&D, with a 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 a $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. And 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 to $26.7 billion, up from $26 billion to $26.5 billion previously. We expect total product sales excluding Veklury in the range of $24.6 billion to $25 billion, up from $24 billion to $24.5 billion previously.
This new range represents growth of 6.5% to 8% for our base business year-over-year, compared to 4% to 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, it's 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 percent 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 percent compared to 2022.
Excluding this legal settlement accrual, non-GAAP SG&A expense for 2023 is expected to be down low-single-digit percentage compared to 2022, consistent with our prior guidance. Non-GAAP acquired IPR&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 IPR&D to be approximately $900 million, reflecting previously committed acquired IPR&D amounts, as well as known milestone payments from existing collaborations. Similar to prior quarters, we will continue to include expected acquired IPR&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 to $10.9 billion, or roughly $650 million lower at the mid-point, due to the $525 million one-time legal settlement accrual and $200 million in additional acquired IPR&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 IPR&D at $0.17 per share and the legal settlement accrual of $0.32 per share in nonrecurring 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. And 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 Instructions] Our first question comes from Geoff Meacham with Bank of America. Please proceed..
Guys thanks so much for the question. Just maybe a quick one for Dan or for Andy, you guys have had an aspiration 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 if it was a small amount, where do you see opportunities in the pipeline that you think the street perhaps is underappreciating? Thank you very much..
Hey Geoff, I'll start and then turn it over to Andy, but thank you very much for the question. I want to be clear that we continue to be on track to meet our goal of oncology representing one-third of our 2030 revenues and that's on top of a growing HIV business overall. I'll just remind the team here that our portfolio is very broad.
It's more than doubled since a few years ago in quantity and many-fold 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.
And Andy why don't -- I'll let you add on to that, in terms of what we -- what our initial assumptions were around a third..
Sir, Hi Geoff, good to hear from you, and thank you for the question. You may recall that historically 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 going to get there based on those two franchises alone.
Magrolimab and TIGIT and the rest of the oncology pipeline provide additional upside.
So 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..
Yes.
May we have our next question?.
Our next question comes from Chris Schott with JPMorgan. Please proceed..
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, would 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 a potential TROP-2 expression biomarker-driven approach that your competitor has alluded to post their data.
Thanks so much..
Thanks, Chris. Over to Merdad, please..
Yes. We are looking forward to sharing those data.
And as you can imagine, we're under embargo, so I can't share too many details until the presentation comes out and the abstract itself will come out I think in mid-August, so very shortly and that initial abstract will represent a relatively small dataset from EVOKE-02 and then there'll be more data at the time of the presentation in mid-September, so in terms of what's coming.
In terms of ILD, across 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. So, at this time, we have not seen anything from -- in an ILD standpoint.
And then in terms of TROP-2 expression, as a matter of course, we are measuring TROP-2 expression in -- in all of our trials as we go forward and looking to see if we see correlations between TROP-2 expression and efficacy, and 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 today. Now that may change with different tumor types. But to date, we have not seen a correlation with TROP-2 expression on those. So, we're optimistic for that and keep to continue. I would not expect to see TROP-2 data in this upcoming dataset.
It's -- this is an early dataset and those data usually trail -- the Trop-02 expression data usually trail the clinical trials..
Thank you.
May we have our next question, please?.
Our next question comes from Tyler Van Buren with TD Cowen. Please proceed..
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.
So, would you say this is attributed primarily to the HR+/HER2- launch? And do you believe this is the beginning of a new sustainable trend?.
Great, Tyler. Yes, over to Johanna, please..
Hi, Tyler. Yes, we are very pleased with the results and the early signs that we've seen from the recent launch of HR+/HER2- 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're 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 and the EC just gave approval for HR+/HER2- in Europe. So, 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+/HER2- in Europe as well. So, we do think this is definitely on the right path from a growth standpoint and very exciting times for Trodelvy and breast cancer patients..
Thank you, Tyler.
May we have our next question, please?.
Our next question comes from Terrence Flynn with Morgan Stanley. Please proceed..
Hi, thanks so much for taking the question. This one's for Johanna. I read that there is -- 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..
Yes, so thanks for the question.
I think you're referring to the National Coverage Determination, the NCD, right, preparation for prep?.
Yes..
I'm assuming.
And that's really just because the -- right now it currently only supports oral drugs and there is an opportunity for us to add injectable drugs and I think that was a we request to CMS and so we're very supportive of course and we believe the path is actually quite central to ending HIV epidemic and fully put -- fully support the CMS proposal.
As from a timing standpoint, that probably hopefully in the coming quarters that we should see something come out, but I don't have details on that, but I do think it can only help what we're trying to do in HIV prevention, let alone support as we think of launching the potential launch for lenacapavir here in 2025..
Thank you.
May we have our next question, please?.
Our next question comes from Robyn Karnauskas with Truist. Please proceed..
Hi, this is Bill Jahangiri on for Robyn. Thanks for taking our question, and congrats on all the progress.
I had a question about TIGIT, and 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 SKY1 would fail?.
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 of course are following biomarkers. As I mentioned, with TROP2, we are looking for biomarkers of responsiveness to various markers that could predict TIGIT responsiveness.
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 we -- that we've seen and others have seen for the efficacy of TIGIT in upper GI tumors.
And so we'll of course across the programs be looking for any potential markers for predictive response..
And may we have our next question, please?.
Our next question comes from Brian Abrahams with RBC Capital Markets. Please proceed..
Hi, there. Thanks for taking my question and congrats on the quarter. Maybe a question on magrolimab. Do you have any preliminary thoughts on why the trial in high-risk MDS was not successful, just given the encouraging early data and I guess what indications are you most optimistic, the drug could still be successful in going forward? Thanks..
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 will of course update as we generate data and look at all those, 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 determine success or failure in these various settings and each of these settings is represented slightly in different biological experiments.
So we are going to continue to look broadly at what -- what we've learned from the initial data.
We're going to 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 going to go, but 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 -- we were hoping we could bring a benefit to those patients and we're disappointed that we can't do that..
May we have our next question, please?.
Our next question comes from Carter Gould with Barclays. Please proceed..
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 a clinical hold, your partner has talked about investigator conduct and bridging therapy being issues, are you sort of in agreement with that characterization and to what extent your sort of timely addressing of the clinical hold, critical to your underlying thesis behind the product? Thank you..
Thanks, Carter. This gives us a chance for all a chance to hear from Cindy for the first time with Gilead. Cindy, over to you, please..
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. That was following a patient death.
The patient was treated with the ddBCMA 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 specified treatment of adverse events. And so we are continuing to partner with Arcellx on this. We are very confident in the molecule.
We're confident in the IMAGINE-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.
And additionally, the FDA has allowed Arcellx to dose patients who had gone through lymphodepletion while on clinical hold. So again, we remain confident that the therapeutic profile of ddBCMA CAR-T and the IMAGINE-1 trial is going to be successful I think based on the data demonstrated to date.
So, our commitment in delivering that therapy to patients globally is still there for multiple myeloma..
Thank you.
Tia, may we have our next question, please?.
Our next question comes from Salveen Richter with Goldman Sachs. Please proceed. [Technical difficulty].
Salveen, we're not -- we're not hearing you very well. Maybe just try one more time. Salveen, maybe you can try and dial in on a different line.
Salveen, you still there?.
Hey guys, can you hear me? This is Matt on for Salveen..
Yes, we can hear you perfectly..
Okay, great. So Daiichi is expected to share full data from the Phase 3 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..
Sure. This is Merdad. Thanks for the question. So, 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.
And I think that will help provide everyone sort of benchmarking in terms of how Trodelvy is doing in that setting.
And then what we'll be looking for I think is consistent with what our belief is for Trodelvy in the second line, which is that patients in second-line are sicker, they tend to have -- they are more difficult to manage and they are more challenging in terms of outcomes, so we are hopeful that we will see a benefit in those patients in terms of outcomes, particularly PFS and OS.
So we will keep ourselves -- keep you updated on the progress of the EVOKE-01 study in the second-line as well. And we're pretty confident that we'll be in where we want to be. Our underlying hypothesis remains that we will have comparable efficacy and that we will have a better tolerability profile with Trodelvy.
So, we're very confident with where we're headed..
Thank you, Tia, may we have our next question, please?.
The next question comes from Colin Bristow with UBS. Please proceed..
Hey, good afternoon, and congrats on the quarter. So the [indiscernible] trial is expected to read out in the near-term. I'm just curious on to get your thoughts really on how you view this from a sort of competitive threat standpoint? Thank you..
I think you may just have answered that question..
So, maybe I'll pick it up. So thanks for the question, Colin. We are -- we have been expecting that data. We're off to -- 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 the lines of therapy because they still use it in the third and fourth line setting when there is still an opportunity to displace chemotherapies.
I think as we've seen with other ADCs in the breast cancer market, I think it does -- it's really healthy awareness of the benefits of ADCs.
And with Trodelvy, is overall survival, both in triple-negative breast cancer as well as in HR+/HER2-, I do think it sets up Trodelvy incredibly well and we've seen also ADC sequencing either from in HER2 to Trodelvy or Trodelvy to in HER2.
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're looking at neutropenia and diarrhea, which are very much in line with other chemotherapies already on the market marketplace, so the physicians are very confident in how to treat versus bringing in something like ILD is going to be a little bit more concerning.
So, more to come and I guess we'll wait to see the data, but today, in the field today, I think Trodelvy is definitely making a difference for the patients.
Merdad, did you want to add anything?.
No. You hit it all..
Thank you, Johanna..
Tia, may we have our next question, please?.
Our next question comes from Evan Seigerman with BMO Capital Markets. Please proceed..
Hi, all. 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 look-forward to BD, you've digested at that, but are you looking at oncology, inflammation elsewhere? Thank you..
Yes, Andy, do you want to start with it?.
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. So, 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 going to 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. So, 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.
But 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..
Thank you.
May we have our next question, Tia?.
Our next question comes from Joe Catanzaro with Piper Sandler. Please proceed..
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 is opportunity to potentially combine it with Trodelvy given some preclinical data that supports that approach? Thanks..
Yes, that's -- I think you hit the nail on the head.
We are 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 and 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.
So, we will update as we go along. I think things are things are progressing very nicely there..
Tia, next question, please?.
Our next question comes from Mohit Bansal with Wells Fargo. Please proceed..
Great. Thank you very much for taking my question and welcome and congrats, Cindy on your new role.
Maybe if I can ask a question to Andy, regarding -- so you have clinical trials going on in oncology especially, how should we think about the operating margin evolution from here? If I take-out the one-time items as well as IPR&D, it seems like about 45% in the first half of the year, is that a good -- good number, good proxy to go with or how should we think about it in the next few years?.
Hi, Mohit, thanks. Thanks for the question. This is an important -- an important point. What we said 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 also have said and acknowledged that we're in a unique point in time as we've built-out both our R&D portfolio and our sales and marketing team with the move into oncology, where our expenses have increased in the short-run and we expect over the coming year 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.
So 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.
And we as we've highlighted, have 21 late-stage Phase 3 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 so.
And I think the way that you've characterized the operating margin in the second quarter is it is entirely consistent with the way that I see it and 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..
Thank you. I think we have time for one last question, Tia..
Our last question today comes from Simon Baker with Redburn. Please proceed..
Thanks for taking my question. With respect to 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..
Thank you very much for the question, Simon. Similar to you, we are very intrigued also by the data that we're seeing in places like autoimmune disease, the 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..
Terrific. So, this is Dan. I just want to close this call by thanking you all for joining.
And maybe just related to some of the enthusiasm of both, the team here in the room and the colleagues throughout Gilead and Kite, 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, we're much further ahead than we expected to be with our pipeline delivery.
Now, we are now 64 ongoing clinical programs, 21 in Phase 3 and you saw that in the news flow for the second quarter. And 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 HID and the epidemic for HIV. So, I just wanted 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 Jacquie and the IR team and we're more than happy to support you. Thank you, everybody, and thanks for joining today..
That will conclude today's conference call. Thank you all for your participation. You may now disconnect your line..