Gilead Sciences Q3 2022 Earnings Call Transcript

Quartr
Provided by Quartr
October 27, 2022

Key Takeaways

  • Total product sales excluding Vectleari were $6.1 billion in Q3, up 11% year-over-year or 15% on an underlying basis excluding foreign exchange and HIV loss-of-exclusivity impacts.
  • Gilead raised its full-year 2022 guidance to $25.9–$26.2 billion in revenues (from $24.5–$25 billion) and $6.95–$7.15 in non-GAAP EPS (from $6.35–$6.75).
  • The European Commission approved lenacapavir (Sunleneka), the first long-acting HIV capsid inhibitor with a six-month dosing regimen, and the FDA has granted its U.S. NDA priority review.
  • Gilead received a complete response letter from the FDA for its HEPLUDEX (blubrotide) BLA over manufacturing and delivery concerns, delaying U.S. approval despite no new clinical trials being requested.
  • The oncology pipeline expanded with Phase 3 trial starts including EVOQ3 (first-line non-small cell lung cancer) and ZUMA-23 (first-line high-risk LBCL), and Trodelbi’s supplemental BLA for HR-positive HER2-negative breast cancer is on track for a February 2023 decision.
AI Generated. May Contain Errors.
Earnings Conference Call
Gilead Sciences Q3 2022
00:00 / 00:00

There are 13 speakers on the call.

Operator

Ladies and gentlemen, thank you for your patience and thank you for attending today's Q3 2022 Gilead Sciences Earnings Conference Call. My name is Amber, and I will be your operator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. It is now my pleasure to hand the conference over to our host, Jackie Roth, VP of Investor Relations. Jackie, please proceed.

Speaker 1

Thank you, operator, and good afternoon, everyone. Just after market closed today, we issued a press released with earnings results for the Q3 of 2022. The press release, slides and supplementary data are available on the Investors section of our website atgilead.com. The speakers on today's call will be our Chairman and Chief Executive Officer, Daniel O'Day our Chief Commercial Officer, Joanna Mercier our Chief Medical Officer, Mehrdad Parsee and our Chief Financial Officer, Andrew Dickinson. After that, we'll open up the call to Q and A, where the team will be joined by Kristi Scholl, the Chief Executive Officer of Kite.

Speaker 1

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 productions and the use of capital and 2022 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 and 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.

Speaker 1

Now, I'll turn the call over to Dan.

Speaker 2

Thank you, Jackie, and good afternoon, everybody. We're pleased to connect with all of you today to share the details of another very strong quarter. Thanks to strong commercial and clinical execution by our teams, The positive momentum continues to build. Total product sales excluding VACLEARY were $6,100,000,000 growing 6% sequentially and 11% year over year. The total including Vicklery was $7,000,000,000 If we exclude the impact of foreign currency fluctuations and the tail end of the loss of exclusivity for Truvada and Atriple and HIV, total product sales excluding Vectleri grew 15% from the Q3 of last year.

Speaker 2

The majority of this growth was driven by HIV and over 40% of the $620,000,000 increase in sales came from oncology. The team will share more details, But this has been a great quarter for commercial execution, including continued share gains for Biktarvy, growing momentum for Trodelvi, another impressive quarter for cell therapy and a strong quarter for VACLURI. We also saw continued clinical momentum this quarter. Some of the highlights include the FDA priority review granted to Trdelbi for late line HR positive HER2 negative metastatic breast cancer, The EU approvals for Yescarta for second line relapsedrefractory large B cell lymphoma and TECARDIS in adult acute lymphoblastic And in virology, lenacapabir received its first regulatory approval in Europe. Marketed as Sunlenka, It is approved for heavily treatment experienced people living with multidrug resistant HIV, making it the 1st approved casted inhibitor and the first therapy with a 6 month dosing schedule for HIV treatment.

Speaker 2

We are taking multiple important steps to advance our ambitious clinical pipeline, including in oncology we are expanding our lung program with 8 trials now active and 3 more planned to start in the coming months. We plan to resume our Phase 2 trial investigating a once weekly oral combination of Merck's aselatravir and rlenecapivir. This will be one of many ongoing combination studies we have for long acting HIV treatment in addition to our extensive program for prevention. And we continue to further strengthen our early stage portfolio adding a BTLA agonist for inflammation from Mirobile and an option for a bispecific antibody for oncology for macrogenics. Moving to our clinical goals for 2022 on Slide 5, We're on track to start the 2 remaining Phase 3 trials, namely, EVOQ3 for first line non small cell lung cancer and ZUMA-twenty 3 for first line high risk LBCL.

Speaker 2

We continue to expect another interim readout for the Phase 2 R7 study in first line non small cell lung cancer before the end of the year. Overall, this has been another very strong quarter and a very strong year for Gilead. We're seeing impressive growth of our base With continued share gains for Biktarvy and excellent performance for cell therapy and growing demand for TRIDELBI. On the clinical side, we've had the first approval for Lenacaparib, a foundational asset for the future of our HIV franchise. Trodelbi is now in a priority review for HR positive HER2 negative breast cancer in the U.

Speaker 2

S. And we're executing on an extensive development program across virology, oncology and inflammation. Finally, the recent TAF settlement is expected to significantly extend the exclusivity of key components of our HIV franchise in the U. S. I'd like to take this opportunity to thank the Gilead and Kite teams for their This consistent execution of our strategy along with a very robust portfolio has led to some terrific progress in 2022, and we look forward to building on that momentum through the rest of the year and beyond.

Speaker 2

With that, I'll invite Joanna to share an update on our Q3 commercial performance.

Speaker 3

Thanks, Dan, and good afternoon, everyone. Before I jump into the commercial results for the Q3, I wanted to begin by acknowledging our team for another exceptional quarter. We're making important progress in our goals of ensuring the strength and sustainability of our virology franchise, while also continuing to build our expertise and market presence in oncology. Turning to Slide 7. We had a very strong quarter with total product sales, excluding Vectleri, of $6,100,000,000 up 11% year over year or 15%, excluding FX and the residual impact of the HIV LOEs with growth in each of our core franchise areas and notable strength in HIV and oncology.

Speaker 3

Sequentially, Total product sales excluding VICTORY grew 6% driven by HIV, HCV and oncology. Growth excluding FX impact and the LOEs was 8%. On Slide 8, HID sales of $4,500,000,000 were up 7% year over year. Excluding the impact of both FX and the LOEs, HIV revenue grew 10% year over year. Similar to last quarter, this was primarily channel mix driven by U.

Speaker 3

S. Government utilization leading to higher average realized price in addition to higher demand. Overall, despite the quarter over quarter shift in average realized price, government plans continue to represent approximately 60% of our U. S. HIV treatment prescriptions, including Medicare in the low 20s.

Speaker 3

HIV revenue growth was driven by the U. S, while Europe was down year over year due to FX and less favorable pricing dynamics, offset in part by higher demand. Quarter over quarter, HIV sales were up 6%, similarly driven by channel mix and inventory dynamics as well as higher demand. Turning to the market more broadly, we are encouraged that on a year over year basis, the HIV treatment market across the U. S.

Speaker 3

And Europe has grown for 5 consecutive quarters. This reflects the work we have been doing with our partners to bring people living with HIV and people at risk of HIV back into care following the pandemic. The market growth we are seeing suggests that activity has returned to pre COVID trends. In Q3 of 2022, the market grew 2% year over year, both in the U. S.

Speaker 3

And Europe. Looking forward, we continue to expect annual treatment market growth in the 2% to 3% range. Descovy sales were $500,000,000 up 16% year over year and 9% sequentially, and prep market share remains stable despite generic and other entrants. For the quarter, the prep market continues to demonstrate robust growth, largely driven by the growing awareness for prep and demand well above pre pandemic levels. Overall, The prep market grew 19% year over year and 6% sequentially.

Speaker 3

Onto Slide 9. 3rd quarter Biktarvy sales were $2,800,000,000 up 22% year over year, driven by higher demand in both the U. S. And Europe and favorable pricing dynamics. Sequentially, sales were up 8% due to higher demand as well as favorable inventory and pricing dynamics.

Speaker 3

Once again, Biktarvy continues to command a leading position in the treatment of HIV with another record quarter growing to 45% market share in the U. S, up 4 percentage points year over year. Moreover, Biktarvy remains the leading medicine for those seeking to switch to a new regimen in the U. S. As well as those starting treatment in both the U.

Speaker 3

S. And Europe. Most notably, capturing 10 new starts for every one person prescribed another medicine in the U. S. Looking to the Q4, I'd like to call out a few points.

Speaker 3

1st, given the historic trend towards a significant inventory build in the 4th quarter followed by inventory drawdown in the Q1, we are renewing our focus on inventory management in an effort to better align the timing of product delivery with end user demand. 2nd, while we continue to see strong market share gains for Biktarvy, In addition to solid growth in both the treatment and prevention markets, we will remind you that some of our second and third quarter performance has been driven by shifts in channel mix that have had a favorable impact on average realized price. Given the favorable trends we observed over the last two quarters, we do expect the channel mix to be more stable in the Q4. With these factors in mind and also allowing for further FX impact, we expect 4th quarter HIV sales to be roughly flat on a sequential basis, noting that full year 2022 HIV growth is therefore expected to be approximately 4% or 7% excluding the LOEs and FX headwinds year to date. In summary, we're extremely proud of the portfolio we have built in HIV and excited about the way Gilead is positioned for 2023 and beyond.

Speaker 3

Specifically, Biktarvy's clinical profile continues to impress, evidenced by ongoing strong growth rates, even though its annual revenue run rate is now in excess of $10,000,000,000 Descovy for prep maintained over 40% market share despite competition and generic entrants. And most recently, Lenacapavir's approval at Sunlenka for heavily treatment experienced people living with multidrug resistant HIV in the EU. This is an important option for a group that has very few treatment options and is a great opportunity for physicians and the HIV community to get more familiar with the 6 monthly subcutaneous HIV therapy. We believe this sets the stage well for our other planned lanycafibr based treatment and prevention regimens. All of this, combined with the treatment and prevention markets showing solid recovery, the impact of the loss of exclusivity of Truvada and Atripla now behind us and the recent CAF settlement extending projected U.

Speaker 3

S. LOEs for Descovy and NUGESI into the early 2030s and June Voya's patent to 2029 in the U. S. All of this truly underpins our confidence that Gilead is well positioned for growth and continued leadership in the HIV market. Now on to Slide 10.

Speaker 3

HCV sales for the 3rd quarter were $524,000,000 up 22% year over year and 17% sequentially, primarily due to the favorable resolution of prior year rebate claim in Europe and other favorable pricing dynamics in the U. S. Offsetting these benefits, There were fewer patient starts in both the U. S. And Europe, consistent with our expectations for both the quarter and the general trends that you should expect in HCV going forward.

Speaker 3

Despite the trend in patient starts, We're pleased to maintain HCV market share of more than 50% in both the U. S. And Europe and 3rd quarter share increased on a year over year basis. For HBV and HDB on Slide 11, sales were up 7% year over year and 13% quarter over quarter, primarily driven by favorable inventory dynamics. Moving to Vectlery on Slide 12.

Speaker 3

3rd quarter revenues were $925,000,000 As expected, sales were down year over year given lower U. S. Hospitalizations as compared to the same period last year. Indeed, though hospitalizations are below the peak seen at the start of the year, It's clear with the sequential increase that the path of the pandemic remains difficult to predict. Nonetheless, We're proud of the role that VEGLARI continues to play in the fight against COVID-nineteen.

Speaker 3

In the U. S, VEGLARI is used in approximately 60% of hospitalized patients who are being treated for COVID. Outside the U. S, VACLEARY's benefit to patients continues to be recognized by health authorities, including the World Health Organization and the European Medicines Agency, based in part on the Pine Tree data, which demonstrated a significant reduction in the risk of hospitalization after a 3 day IV treatment in the outpatient setting. These factors continue to support VEGLEA utilization where it's needed.

Speaker 3

Moving to oncology and beginning with TRIGELVY on Slide 13. Sales of $180,000,000 grew 78% year over year and 13% quarter over quarter, and we continue to work with regulators, payers and clinicians around the world to broaden access. Since its approval in second line metastatic TNBC late last year in Europe, TDALI is now reimbursed in 13 countries outside the U. S. With additional markets in Europe and elsewhere expected to come online shortly.

Speaker 3

We've also begun work on establishing the right to support a potential launch into pretreated HR positive HER2 negative metastatic breast cancer. Reinforcing the significant unmet need in this population and the clinically meaningful overall survival data demonstrated in the Phase 3 TROPICS-two study. FDA has accepted our supplemental biologics license application as priority review, and we look to a decision in February of next year. We're excited by the potential for many more patients to benefit from Chidavi. Now on to Slide 14 And on behalf of Christy and the Kite team, I'm pleased to share that cell therapy sales in the 3rd quarter were $398,000,000 up 79% year over year and up 8% sequentially.

Speaker 3

These strong results were driven by continued growth in large B cell lymphoma and Kite's ability to reliably meet customer demand. Together with our recently FDA approved viral vector manufacturing facility in Oceanside, Kite remains well positioned to ensure clinical and commercial supply availability, while it continues to execute on its geographic expansion. For the quarter, Yescarta sales of $317,000,000 were up 81% year over year and 8% quarter over quarter, driven by continued successful launch in second line LBCL in the U. S. And partially offset by FX headwinds in Europe.

Speaker 3

Just last week, Yescarta was approved in the EU for second line LBCL, and we look forward to launching there in the months ahead. Tecardis grew 72% year over year to deliver $81,000,000 in sales, driven by growth in adult acute lymphoblastic leukemia. In early September, the European marketing authorization for Tecartis in relapsed or refractory ALL was granted. We continue to broaden awareness and access to our cell therapies through indication and authorized treatment center expansion in existing markets as well as through geographic expansion as demonstrated by our most recent regulatory applications in Brazil, Singapore and Saudi Arabia. As always, Christy is available for Q and A later on the call.

Speaker 3

Overall, this was an incredibly strong quarter for Gilead Oncology with revenue of $578,000,000 up 10% from last quarter and 79% from last year. This represents an almost $2,400,000,000 annual run rate as we move into the last few months of 2022 and hints at the possibilities ahead as we continue to execute on our commercial and clinical oncology goals. And with that, I'll hand the call over to Murdock for an update on our pipeline.

Speaker 4

Thank you, Joanna. Before I start, I'd like to recognize the strong execution of our internal team and external partners across a broad range of activities that's diversified across therapeutic area and clinical stage with milestones spanning study initiations, the SVLA submission for TRIDELVI, 2 EC approvals in cell therapy and our first approval for Lenacapivir in the EU. On Slide 16, you can see that we've made a lot of progress so far this year, meeting nearly all of our milestones. Regarding our BLA filing for HEPLUDEX, we received a complete response letter from the FDA setting concerns about the manufacture and delivery of HEPLUDEX. We will take the time to fully digest the CRL, but note that no new Safety or efficacy clinical trials were requested by the FDA.

Speaker 4

We plan to resubmit as quickly as possible and we'll work with the agency on the path forward. We remain confident in blubrutide and the potential benefits it can bring to people living with HDB, and we'll share an update on the U. S. Regulatory pathway when we can. Moving on to HIV on Slide 17, We're thrilled that linacapavir received its first marketing authorization from the European Commission as Sunleneca for people living with multidrug resistant HIV in combination with other antiretrovirals.

Speaker 4

Silyanka is a 1st in class capsid inhibitor. It's the 1st and only twice yearly subcutaneous HIV treatment and adds a much needed option for those people living with HIV with limited alternatives. We continue to expect a decision on our NDA from Lenacapavir from FDA in late December of this year. In the meantime, this first regulatory approval from the EC is an important validation while we continue to progress our other linacapavir based treatment and prevention programs. For HIV treatment, a new clinical development plan allowing a lower dose of islatravir, Merck's investigational NRTTI is moving forward after FDA review.

Speaker 4

As such, we're planning to resume the Phase 2 trial investigating oral once weekly Lenacaprevir and his Latvivir combination. Our internal combination programs are also ongoing and we expect to share data next year from the Phase 1b proof of concept study for lenacapavir and 2 broadly neutralizing antibodies or bNABS directed at HIV. In prevention, our clinical development continues to progress with 4 in process or planned clinical trials evaluating every 6 months subcutaneous on the capabir. Moving to Slide 18, VICLARI continues to be recognized as a standard of care for patients with severe COVID-nineteen with updated guidelines for VICLARI from the World Health Organization. Additionally, the CHMP issued a positive opinion on the use of for the treatment of pediatric patients with COVID-nineteen.

Speaker 4

Although novel treatments and vaccinations have improved the COVID-nineteen outlook, There's a continued need for effective and convenient oral treatment options for patients. I'm pleased to share that the FDA has just granted our novel oral nucleoside GS-five thousand two hundred and forty five fast track designation, which aims to expedite development of promising new medicines. We continue to be in active discussions with the FDA and other global regulators on potential clinical pathways, including a Phase 3 study that we expect to start within the next several months, either globally or outside the U. S. On Slide 19, we show the Phase 3 TROPICS-two results in patients with HR positive HER2 negative metastatic breast cancer, there was a late breaking presentation at ESMO in September.

Speaker 4

Trudellbe demonstrated a statistically significant and clinically meaningful 3.2 month overall survival benefit. Patients with metastatic HR positive HER2 negative breast cancer who have progressed on endocrine based therapies and chemotherapy have limited options. As a reminder, the patients enrolled in TROPICS-two were heavily pretreated with a meeting of 3 prior chemotherapy regimens addition to prior CDK4six inhibitors. Importantly, the FDA recently accepted our SBLA for TRUDElvi and HR positive HER2 negative metastatic breast and granted it prior to review. The PDUFA date is currently set for February 2023.

Speaker 4

We continue to work with regulatory agencies outside the U. S. Potentially make this medicine available to eligible patients. Additionally, following the acquisition of Trdelbi's Asian commercialization and development rights from Everest Medicines, We expect data from our Phase 3 metastatic TNBC China bridging trial in the next few months and our Phase 3 HR positive HER2 negative metastatic breast cancer study in mid-twenty 23. Moving to lung cancer on Slide 20, you can see that we expect to have at least 9 active clinical trials in non small cell lung cancer by the end of 2022, including 5 with Tridelvi as well as programs with nimbrelumab, dombenilumab and etruma, Merck's KEYTRUDA, AstraZeneca's durvalumab and our own nagrolumab.

Speaker 4

A trials are already underway, including the Phase 3 EVOKE-one study in second to third line non small cell lung cancer and our Phase 2 EVOKE 2 study in first line non small cell lung cancer without actionable mutations. Our partner Merck also plans to initiate the Phase 3 EVO3 study later this year to evaluate the combination of Tridaldi and Keytruda in first line patients with non small cell lung cancer whose tumors express high levels of PD L1. Additionally, with our partner Arcus, we're looking forward to the 4th interim analysis of the Phase 2 ARC7 trial evaluating ZIM and DOM in PD L1 high non small cell lung cancer before the end of the year. Data from ARK7 are expected to support our ongoing Phase 3 studies for DAW based combinations in lung cancer, including STAR-one hundred and twenty one, which just achieved 1st patient in. Lung cancer is a disease area with high unmet need and we believe we have multiple promising MOAs and potential combinations that could help bring additional new treatment options to patients.

Speaker 4

To explore these opportunities, we plan to initiate 2 Phase 2 signal seeking platform studies, velocity and the Arcus led edge lung in the coming months. Overall, we had initiated a comprehensive evaluation of the assets in our portfolio to address the significant unmet need in lung cancer and look forward to sharing updates in the coming years. Moving to Slide 21 and on behalf of Christy and the Kite team, we're highlighting our expanding clinical pipeline as we build on the growing momentum and adoption of cell therapy based on the significant survival benefit that Yescarta and Tecartis are delivering to patients. We believe there are still opportunities to bring Yescarta and Tecartis to more patients by moving into earlier lines as well as new indications. As you can see, we have recently enrolled patients in several studies, including ZUMA-twenty four, the Phase 2 study to evaluate Yescarta in an outpatient setting for second line LVCL and ZUMA 22, Phase 3 study for Yescarta and second line plus high risk follicular lymphoma.

Speaker 4

We also expect to begin screening for patients for the ZUMA-twenty three study of Yescarta in Q4. The decision to initiate a Phase 3 trial in first line HR LDCl was based on the encouraging data from ZUMA-twelve, where Yescarta demonstrated 89% ORR and 78% CR. Additional studies include an evaluation of Tecartis in rare B cell malignancies and KITE-three sixty three that's evaluating a CD1920 bisistronic CAR T and post CD19 third line plus LBCL. We're committed to continuously improving the safety and efficacy of our cell therapies through both internal pipeline and external partnerships. On Slide 22, we turn to hematology and highlight the breadth of our programs across MDS and AML.

Speaker 4

For migrolimab, we fully enrolled our Phase 3 ENHANCE study in MDS ahead of schedule. Our discussions with the FDA and other regulators continue and we expect to share an update in early 2020 3. Moreover, enrollment for the 2 AML trials, ENHANZE 2 and 3 is well underway and we're targeting top line data in 2024. A few weeks ago, we announced our oncology collaboration with MacroGenics to develop bispecific antibodies. This includes the exclusive option to license MGD-twenty four, a bispecific antibody that binds to CD123 and CD3 currently in Phase 1, as well as 2 additional research programs.

Speaker 4

This complements nagrolimab and furthers our work as we explore therapies that could translate into better clinical outcomes for patients with AML and MDS. Finally, we are pleased FDA granted KEY-two twenty two orphan drug designation at the end of September. It's the first CLL-one targeted CAR T and is currently enrolling patients in a Phase 1 study. On Slide 23, I want to take a moment Welcome NeuroBio to Gilead. We completed the acquisition a few weeks ago and pleased to add the NeuroBio team to the Gilead Research family and bring their proprietary discovery platform and immune inhibitory receptor agonists to our portfolio.

Speaker 4

This acquisition complements our inflammatory disease cornerstones including IBD, RA and systemic lupus and opens opportunities in other indications. We're excited to continue to explore and develop these antibody agonists, which we believe have the potential to induce immunosuppressive signaling and restore tolerance in autoimmunity. Wrapping up, I'll note that we now 60 clinical programs underway here at Gilead, spanning a broad range of indications across virology, oncology and inflammation. We've accomplished a lot in 2022 and yet feel we're really just getting started in exploring the possibilities offered by our portfolio. With that, Andy?

Speaker 5

Thank you, Bernad, and good afternoon, everyone. We are pleased to share another strong quarter of results with sequential year over year growth in every franchise across our core business. As shown on Slide 25, Product sales excluding Vectlory grew 11% year over year despite $130,000,000 headwind from FX. If we exclude this FX impact, in addition to the impact of previous HIV LOEs, total underlying sales growth year over year was 15%. Moving to Slide 26, you can see that Vectlery was down as expected year over year, although it more than doubled on a sequential basis from the Q2.

Speaker 5

I'll note that with the continued strengthening of the U. S. Dollar, the total FX impact on revenue, net of hedges, was higher than expected at approximately $200,000,000 compared to the Q3 of last year. Non GAAP product gross margin was 87%, down 3 20 basis points from last year, primarily due the Q3 of 2021 reversal of a previously recorded litigation reserve. Additionally, non GAAP Product gross margin was impacted by higher Biktarvy related royalty expense and lower Vectarvy sales.

Speaker 5

Non GAAP product gross margin improved sequentially due to higher HIV and Becklery product sales. Non GAAP R and D, excluding acquired IPR and D expenses was $1,200,000,000 up 10% year over year, primarily due to investments in oncology. Sequentially, R and D excluding acquired IPR and D expenses was up 6%, driven by investments in oncology and COVID treatments. Acquired IPR and D, reflecting acquisitions, milestones and upfront payments for the quarter was $448,000,000 and includes $389,000,000 of expense related to the Miro Bio acquisition. Non GAAP SG and A was $1,200,000,000 up 3% year over year.

Speaker 5

Non GAAP operating margin was 47%, down year over year and driven primarily by higher required IPR and D expenses and lower Vectlury sales. Sequentially, non GAAP operating margin increased 400 basis points due to higher HIV and Vectlure sales, partially offset by higher acquired IPRD expenses. Non GAAP effective tax rate in the 3rd quarter was 22.4%, higher than normal due to the non deductibility of the upfront Miro Bio payments. Overall, our non GAAP diluted earnings per share was $1.90 in the Q3 of 2022 compared to $2.65 for the same period last year. Of note, the Miura Bio transaction impacted post tax EPS by $0.31 a share and this was not reflected in the full year guidance we shared back in August.

Speaker 5

On Slide 27, we take a quick look at our performance year to date, which shows total product sales excluding Vectlery of $16,700,000,000 up 7% year over year. If we exclude the approximately $385,000,000 of FX headwinds year to date As compared to the same period last year, in addition to the impact of the HIV LOEs, the underlying growth year to date is 11%. VEGLORI, as expected, is down year to date highlighting the lower demand for COVID-nineteen treatments in this stage of the pandemic. Moving to Slide 28. We are increasing our full year sales guidance to reflect our year to date results and our expectations for Q4, including our latest view of FX.

Speaker 5

For revenues, we now expect total product sales of $25,900,000,000 to $26,200,000,000 up from our previous range of $24,500,000,000 to $25,000,000,000 This reflects the strong performance year to date, notably very strong growth in HIV, Vectlory and cell therapy and incorporates our expectations for the broader macro environment, including FX, which will once again be a headwind in the Q4. In HIV, as Joanna discussed, we expect HIV revenue in Q4 to be roughly flat on a sequential basis. In cell therapy, we expect slower growth on a sequential basis, primarily due to stabilizing demand following the 2nd line LBCL launch and FX headwinds. Additionally, we are taking a cautious view with regards about the current shortage of fludarabine, which we expect to be partially mitigated later in the Q4 and to the competitive landscape as our peers improve their manufacturing reliability. Moving to Vectlory and with year to date revenue of $2,900,000,000 we are increasing our expectations to approximately $3,400,000,000 for the full year.

Speaker 5

Note that we expect VEGLORI sales to continue to track hospitalization rates and our guidance assumes no significant increase in hospitalization rates from the 3rd quarter levels. Excluding Vectlury, we expect our total product sales to be $22,500,000,000 to $22,800,000,000 representing growth of 5% to 6% year over year compared to our prior range of $22,000,000,000 to $22,500,000,000 As for the rest of the non GAAP P and L, product gross margin is now expected to be in the 86% to 87% range compared to our prior guidance of approximately 85% to 86%. There is no change to our R and D guidance where we expect full year R and D expense to increase by a mid single digit percentage compared to the 2021 baseline of $4,500,000,000 Moving to acquired IPR and D, we are not issuing guidance for the full year and similar to what we did with Miro Bio this quarter, We'll update our EPS guidance quarterly as needed to reflect any relevant activity during the quarter. What we've included here is the year to date acquired IPRD amount, including approximately $0.04 per share associated with the MacroGenics collaboration that we announced last week. The guidance shared today does not include any upfront payments related to normal course of business partnerships or licensing deals that we might close in the Q4.

Speaker 5

For SG and A, with our continued investment across our commercial organization and expectations for higher costs as a result of inflation, We continue to expect SG and A expenses to grow by a low single digit percentage compared to 2021. Altogether, we expect income to be $11,800,000,000 to $12,200,000,000 for the full year, up from $11,000,000,000 to $11,600,000,000 previously. And finally, we now expect our non GAAP diluted earnings per share to range between $6.95 to $7.15 per share, up from $6.35 to $6.75 previously. This EPS guidance range is approaching our 2021 non GAAP EPS results despite an expected $2,200,000,000 decline in Vectlory revenue and a more than $500,000,000 in total FX headwinds anticipated through the end of the year as compared to 2021 rates. This highlights the strength of our core business, which is now expected to grow in the 5% to 6% range in 2022.

Speaker 5

On a GAAP basis, we expect our diluted earnings per share to range between $3.35 $3.55 per share compared to $2.90 $3.30 per share previously. Finally, on Slide 29, you can see that there is no change to our capital allocation priorities. In the quarter, we returned over $1,100,000,000 to shareholders, including $928,000,000 in dividend payments and $180,000,000 in share repurchases. As we announced previously, We repaid $1,000,000,000 of debt early in the Q3 and have returned to the same debt level we were at prior to the Immunomedics acquisition. With that, I'll invite the operator to open the Q and A.

Operator

Of course, thank you. We will now begin the Q and A session. Please limit yourself to one question at a time And please re queue for any follow-up Our first question comes from Chris Schott with JPM. Chris, your line is now open.

Speaker 6

Great. Thanks so much for the question. My question was on Lenacaprevir and in treatment. I want to talk a little bit about maybe first I slat Trevir and the lift of the clinical hold. How interesting is that as a partnered asset Relative to your internal programs.

Speaker 6

And then the second part of that, just a bigger picture one in treatment. Do you see the portfolio with linacaprevir resulting in It's a number of different combos that serve different segments of the market or is it more likely going to end up with one of these combos that really separates from the other and becomes an anchor type asset like we see with Biktarvy. Thanks so much.

Speaker 4

Hi, Chris. This is Murdad. Let me first start by saying that we are really excited about the recent approval for Lenacapavir in this in the highly treatment experienced population. Obviously, that's a group of people who have limited options and I think Lenacapavir is a new What we like about AZLATRAVIR is that it is fairly late in its development. We are able to be in Phase 2 with that and I think it provides us the relatively near term opportunity to launch a partner in treatment for Lenacapavir that could be given in a long acting way.

Speaker 4

And I think that's really important in terms of where the market is going and what our goal is in terms of, as we've said before, providing a long acting parenteral option that is longer than is in the 3 months or longer timeframe and we're optimistic about our ability to do that. So for that, we have our internal pipeline assets that are really providing our options there. For islatrevir, that's part of our oral program. And for us, we do think that we have a number of opportunities In terms of oral programs to provide weekly oral treatment options for people using Lenacapavir And right now, it's a potential. Certainly, as lazrovir is an option there and we have other options in our pipeline that could potentially Get that.

Speaker 4

So get to that level. So the way I look at it, just to answer directly your last question, We do think that there will be a Linacapavir partner and there will be probably one partner that will Achieve our therapeutic goals in oral, potentially a different partner in parenteral. And As we go forward, if we can make improvements, whether that's selenicapivir and being able to provide even longer than 6 months therapy or to the partner that we could extend the duration of therapy with a different molecule or different formulation, we will always try to get to that longer exposure. So over time, I expect us to continue to try to innovate and move forward.

Speaker 3

So maybe just to add to that, Chris, in light of what Murdad was just referring to, we've done a lot of patient market research to really understand the segments within the oral market, but also with the long acting market, specifically in treatment, which is quite different to your point to prevention. And in the treatment setting, It is clear that you will always have a market for that daily oral, which we believe Biktarvy has really set the standard there. And then there are others that The weekly oral will be more preferred. Some people just want to make sure they're taking something every single day. Others don't want to be reminded that they have HIV.

Speaker 3

And then you have obviously the injectable through the subcu with lanycapivir combination every 3 months or potentially even every 6 months that will be very appealing to some that don't want to be reminded at all. And so those are kind of the segments we're trying to play out. So I do think in the long acting, there will be more of a split Segments than we've seen in the daily orals.

Speaker 1

Amber, are you ready for the next question, please?

Operator

Our next question comes from Salveen Richter with Goldman Sachs. Salveen, your line is now open.

Speaker 7

Good afternoon. Thanks for taking my questions. On the TIGIT program, what is the likelihood that we'll see PFS data at this And if we don't, when could that come? And then based on the interim updates, it does seem like you already have clear benefit on ORR at least on the doublet arm versus Monotherapy, so would love to see if you could just walk us through the possible scenarios with this data readout and if there's any outcome that could impact that recently initiated Phase 3 studies.

Speaker 4

Thanks, Sali. This is Murdett again. Yes, maybe I'll start by saying that really nothing has really changed in terms of the ARK7 study and where we're headed. And the reminder I'll make is that this is going to be the 4th interim analysis for the ongoing Phase 2 study and Enrollment was only recently completed over the summer. And so when we look at that, if you think about it in that context, To your point, we continue to look for consistency in the Dom and ZIM combination as a doublet in the ORR to bolster our ongoing Phase 3 program, right, just to underline our confidence in the TIGIT and DOM combination.

Speaker 4

Based on the data we've seen already and this should continue to support that. In terms of PFS, I think PFS is, as I tried to allude Given the fact that enrollment went on until fairly recently, the likelihood is the PFS is going to be fairly immature and may not be informative. And certainly, when we think about the triplet there as well, It's unlikely that PFS is going to be informative, but it may be. And so we'll look at that and our plan is to evaluate the data and then decide with our partners at Arcus What the data and how we approach it and certainly as we've said before making sure that we are sharing the data at a medical conference next year. And exactly to your point, it's really about confirming The confidence we already have in TIGIT and moving into Phase 3 with our lead with the lead programs that we're moving with.

Speaker 4

So Hope that answers your question.

Operator

Our next question comes from Brian Abrahams with RBC. Brian, your line is now open.

Speaker 8

Good afternoon. Congrats on the quarter and thanks for taking my question. A question on FIDELVI. With the maturing TROPICS-two overall Survival data and the evolving competitive landscape. I'm curious on your latest views on where you see TRUDElvi fitting in and the HR positive HER2 negative population.

Speaker 8

Any updates on market research, on how it might be used, your commercial strategy to align with that? And curious also your latest expectations on how effective it could be post in HER2 in certain patients who may receive that first? Thanks.

Speaker 3

Hi, Brian. It's Joanna. Thanks for the question. So basically, let me start by saying with Tidelvi, the performance for the quarter has been really strong. We're seeing 78% year on year growth, 13% quarter over quarter, and we're seeing markets add in every week basically, and reimbursement kind of playing out.

Speaker 3

We have now over 13 countries ex U. S. That have gotten reimbursement. So we're seeing really strong launches, namely France, Germany right now and other markets coming in as we're speaking. So strong foundation there.

Speaker 3

I think having OS data in both triple negative breast cancer as well as now at least tropics 2 in the HR positive HER2 negative Patient population really helps the foundation for Trudelvie, but really helps across breast cancer. To your specific question around, kind of where do we position ourselves, Obviously, with TROPICS-two, we're in previously treated, heavily treated lines of therapy, right, when you think about Patient population, so a little bit different than some of our competitors. And so we're excited actually because these patients have very limited options. And so now with TRIDELBI, there's a real potential for overall survival in these late line patients. So we do think that as we're playing it out, as we're doing our market research, we feel very confident that Trevalvie will be very well positioned in the marketplace And we'll build on the success that we've seen thus far in triple negative breast cancer as well, in how we're playing that out.

Speaker 3

So we expect continued momentum in our base business. And I might have mentioned before in one of the previous calls how we've expanded our footprint specifically in the U. S. To prepare for both Not only the expansion of what we need to do in triple negative breast cancer, but also what we need to do in HR positive. And so we're well poised to make sure that we're ready for that PDUFA date coming up in February, to make sure that we're successful.

Speaker 4

And maybe this is Murda. Maybe I'll add to that. We're not done, right? I think we're How much we've been able to achieve with Tridelby so far and you've seen consistent positive data across Tumor types and in particular I think as Joanna highlighted the late line therapy. Certainly Those are patients who may now, there's a potential that some of them will be getting in HER2 beforehand.

Speaker 4

We don't have data on sequencing, but I do believe that there may be those who decide to treat for those patients who may not respond adequately to in HER2 to later lines, right. So that's kind of where certainly there's an opportunity there. The other thing I would add is that We've got really strong data in triple negative breast including the HER2 sorry, in HR positive breast cancer, including the HER2-zero population. And I think that's a very important distinction and really important to remember. And then finally, Based on what we've seen so far and the clinical benefit we've brought, we certainly believe that there's an opportunity for us to move to Earlier lines of therapy as well in breast cancer, in triple negative, in HR positive and in other tumor types.

Speaker 4

I think that's Our excitement about triadalupe has always been the ability to go into broad tumor types and our strategy has always been to advance into earlier lines of therapy

Operator

Our next question comes from Michael Yee with Jefferies. Michael, your line is now open.

Speaker 9

Hey, guys. Thanks. Congrats on a great quarter. I also wanted to ask Murda a question on Trudelian lung cancer, I mean, I would think that this is even bigger opportunity than breast cancer. On EVOQ1, which is ongoing.

Speaker 9

Can you confirm you think you would update in next year and how you think about that opportunity versus second line docetaxel? I know there's some early response rates based on the basket study when you acquired Immunomedics. And I was wondering if you've had more data in lung cancer that you've been observing to give you more confidence there. And then you commented on EVOQ2 and EVOQ3, which is the first line. I just want to understand, do you think we would update on EVOQ2 next year?

Speaker 9

I would think that's pretty big trying to replace chemo. Maybe comment on EVOQ1 and EVOQ2. Thank you.

Speaker 4

Yes. Michael, Murdad, thanks for the question. I think just to follow on, it's a great follow on to the Prior question around our ability to really look across tumor types and earlier lines. And in particular, I think What you're referencing is our confidence in going to early line lung cancer and starting those studies. To your point, we've seen data as you know very well from our early Phase 1b study in lung cancer And we continue to enroll and we've initiated now studies looking at both the second and third line setting and then as well as in the frontline setting.

Speaker 4

As you know, we're doing a study in combination VOCO-three with the PD-one and the PD L1 high population, which I think is really an important trial for us to proceed on. So, I think what I would say is that, the timing of the data, Michael is always difficult to predict. We have to see how the study enrollment goes in its early days. But we're really excited about the opportunity to bring A meaningful therapy to a group with a very high unmet need.

Speaker 1

And we have a next question please.

Operator

Our next question comes from Brian Skorney with Baird. Brian, your line is now open.

Speaker 10

Great. Thank you for taking

Speaker 6

the question. Maybe perhaps for Murda, just kind of jumping off on the long acting HIV discussion. I noticed in the pipeline slides, long acting bictegravir has been removed from the pipeline. Obviously, it would have been nice to have a known entity like Biktegravir, part of the combo. I was just wondering, if you could give us any insight to what happened in the Phase 1 there?

Speaker 6

Is it sort of Biktegravir missing a PK threshold? Or is it something that you're seeing with the 6212 or 5,894 that gives you more confidence there? Thanks.

Speaker 4

Yes. Thanks for the question. Happy to expand on that. Yes, look, bategravir is an amazing molecule and has done a lot for patients. And, one of the opportunities we looked at is, in addition to thinking about vitegravir for long acting oral was to see if we could give it as a long acting subcutaneous.

Speaker 4

And really what happened is we had Tolerability issue is just giving that molecule subcu in terms of injection site reaction. So it's not about the molecule itself. One of the challenges of developing long acting subcutaneous therapies is tolerability. And I want to make sure that it's clear that bactero gravir as an oral agent continues to be a huge part of where we want to go. And then maybe just to step back to your point, the way I think about it, maybe the way to think about it is from a prep standpoint, long acting, We are Lenacaprevir, it's prep for long acting and that those studies are underway moving along nicely.

Speaker 4

From a treatment standpoint, as I mentioned earlier, lenacapavir is a huge part of our backbone therapy for us. And Now we are looking at a number of different opportunities to get to long acting oral and long acting parenteral. And molecules like lenacapavir don't come along every day. We are looking for At a number of molecules, we think we have the world class expertise in chemistry, in preclinical development that gives us a leg up on the competition to get to those molecules that will really get to the need that Joanna laid out, Which is to get to the subcutaneous or every 3 month dosing or even longer and that's what we're looking for.

Speaker 1

Amber, may we have our next question please?

Operator

Our next question comes from Matthew Harrison with Morgan Stanley. Matthew, your line is now open.

Speaker 11

Great. Good evening. Thanks for taking the question. I just wanted to ask Question on 5,245. Can you just talk a little bit about the range of possibilities you might be thinking about in terms of what a Phase 3 might look like?

Speaker 11

And then Just sort of where you see commercially, what sort of data you might need to compete just given the fact that it may be hard to have the same kind of data set as some of those that pills that were developed earlier in the pandemic. Thanks.

Speaker 2

Hey, Matthew, Dan O'Day here. So we'll have Mehrdad take the first part of your question and then Joanna compete into the second.

Speaker 4

Thanks, Dan. Yes, thanks, Matthew. So 5,245 has As you know, we started those trials in Phase 1 earlier this year. Things are going well. And as you know, the pandemic has changed a lot.

Speaker 4

And I think you make an excellent point that looking at high risk patients is a challenge right now and looking at high risk patients who may get hospitalized is Challenge right now given vaccination other treatment options. So exactly to your point, I think the discussion we're having Internally and with our regulators is what's the best population for us to establish the benefit of 5,245 And how does that anticipate what might come down the road, which has been the unpredictable part, whether that is Resistance to other agents, the need for combination agents, new variants that may increase the hospitalization rates, Those are all the things that we have to be prepared for. And we really see 5,245 as a way as we move forward And move into clinical trials once we demonstrate efficacy as an important tool, should the pandemic start to Pick up again, heaven forbid. But that's how we think about it. So both combinations and treating resistance or A new surge.

Speaker 3

Yes. So in line with that, Matthew, it's Joanna. I would just add to what Mirna was saying. So I think from a commercial standpoint, what we're thinking is The fact that it doesn't have a boosting agent is a real plus here as well as the fact that we're going to look at rebound effects as we've seen with current marketed Products right now have that issue and so in addition to the antiviral activity. So I think those pieces are kind of what we're thinking about.

Speaker 3

As well as you know, as you well know, drug drug interactions has been a bit of an issue with some of the current agents today. So I think if you without the boosting agent, I think those will just open up a little bit more for a broader patient population potentially to really benefit. And as we've seen with this pandemic, it's not over. We've seen hospitalizations go up and down. We've seen a little bit of an increase most recently, and we're tracking that very closely with hospitalizations, of course, because of that glory.

Speaker 3

But we do believe that there's still opportunity for more options here to make sure that we curve this pandemic.

Speaker 2

And Matthew, this is Dan O'Dare. I'll just add one other thing in addition to my colleagues, which is, in our conversations with the U. S. Government, particularly the recent Fast Track designation that was applied to GS-five thousand two hundred and forty five, there's 3 major things that they're interested in too. Number 1 is more oral antivirals.

Speaker 2

Number 2 to the points that both Mehrdad and Drenna made working across The variance as the virus continues to mutate. And then thirdly, lack of DDI, lack of boosting and this rebound issue. So I think it's a recognition of the fact that there is a need for the ongoing Pandemic, endemic, whatever you want to call it with COVID for additional options. And I think that's expressed in the way the U. S.

Speaker 2

Government wants to work closely with us as we continue to develop this program.

Speaker 1

Amber, may we have our next question please?

Operator

Our next question comes from Tyler Van Buren with Cowen. Tyler, your line is now open.

Speaker 6

Hey, guys. Thanks. Congratulations on the results. Great quarter. I had a follow-up high level Question on Biktarvy.

Speaker 6

So the product continues to see very impressive uptake and it looks like it will be around 60% of HIV product revenues this year. So Where do you expect the product to peak out as a percentage of HIV sales over the next several years?

Speaker 3

Tyler, it's Joanna. Thanks for the question. I would say that we're really proud of the Biktarvy performance, but I would say even the increased Momentum that we're seeing and this is not just in the U. S, this is really around the globe. And so we're just about 45% market share with Biktarvy.

Speaker 3

We've seen 4% share gain year on year. And now we're looking at an annual run rate in excess of about $10,000,000,000 So I do think we're very well poised for the future. We're looking at both the naive share, obviously, and we've got just about under 60% of that share right now with Biktarvy. So really setting the standard for new patients coming into HIV. And obviously, the switch share, I mean, you can't Switch share is obviously a little bit lower because you can't switch to Biktarvy if you're already on Biktarvy.

Speaker 3

So therefore, we're tracking that very closely as well, but making sure that when there is opportunity either from older drugs or when there's been some issues for patients to really come on to Biktarvy, just because it really does have a profile from an efficacy standpoint and safety standpoint. So we do believe that continued growth With Biktarvy is on the agenda and I would also add just a little bit of a note around the market as well, which also helps, right? Because Where the market goes, Biktarvy goes and where Biktarvy goes, the market goes. We've seen market stabilization actually back to pre pandemic levels and growing at about 2% or so year on year, both in the U. S.

Speaker 3

As well as in Europe. And so that also really helps our momentum Continue and Biktarvy is driving that as well. Of course, in a lot of our efforts, the teams have worked very closely with community partners and physicians and advocacy groups to make sure that we get patients back into clinics, back into care, both from a screening standpoint and diagnosis standpoint. Now that we're back and you really see those numbers back to pre pandemic. So I think we're in good place moving forward and well poised for the future to continue this leadership in HIV driven by Biktarvy.

Speaker 1

I think we'll squeeze in just 2 more please. Maybe go to the next caller.

Operator

Our next question comes from Umer Raffat with Evercore. Umer, your line is now open.

Speaker 12

Hi, guys. Thanks for taking my question. I wanted to touch up on a slightly different topic today. And I have a 2 part question for Dan and Andy. And this is on the tenofovir litigation that's been ongoing.

Speaker 12

And then I guess my question really was, There's a very unusual amount of plaintiffs aggregated up in this case. And I'm curious, Is it something you guys are looking to take to a final judgment or would you be open to a settlement? And that brings me to sort of the second part. Andy, How much of a legal charge have you taken on this litigation to date? Because I know you've been doing that on the Biktarvy and other indications litigations in the past.

Speaker 12

And is there something more significant that has to happen for a more prominent charge to show up? I ask because every company handles the accounting differently. So I was just curious. Thank you.

Speaker 2

Thanks, Umer. Let me just start before I hand it over to Handy to say, obviously with any litigation, We don't comment on ongoing litigation in any level of detail. I do want to emphasize the confidence we have in our overall patent portfolio in general. And maybe with that, I'll hand it over to Andy to answer some more specifics of your question as well.

Speaker 5

Yes. Thanks, Dan. Hi, Umer. Thanks for the question. I'm happy to touch base on this.

Speaker 5

This is a topic, as you know, that we've been getting a lot of questions on with the Zantac litigation. So a number of things that I can provide some background and context. So first of all, like most companies, anyone operating in the U. S, We are routinely managing a lot of different litigation matters. As you know, many of those are from our perspective meritless or baseless.

Speaker 5

As a matter of practice, we don't typically or usually comment on specific litigation cases. What I can say stepping back is that, we have won or resolved the 3 material litigation matters Over the past year, as you know, on terms that were favorable to the company and to our shareholders, that is the Juno Kite IP litigation, the Vive IP litigation around bictegravir and the third was the TAF litigation with generic companies. We have an outstanding legal team both internally and externally. And then maybe to your specific question, I mean, we have complete confidence in the merits of the defense on the ongoing product liability case. So it is very different than the Zantech litigation case.

Speaker 5

So just to your question on the number of plaintiffs, for instance, if I remember correctly in the Zantac cases, there were 250,000 patients in our case I'm sorry, I'll tell you this. There were 25,000 in ours, but the key difference is that the issues at hand here, I mean, Our TDF based products are lifesaving products that really transform care for HIV and the side effects of the products We're in the label from day 1. The labels in the U. S. And Europe were slightly different, but the labels were there.

Speaker 5

These were well known, well disclosed potential side effects. And I think that's an important piece of it. So it's a very different case. Zantac, if I remember correctly, was taken off the market and reformulated. So be careful about drawing too many parallels between what you saw with Zantac and some of the companies that were affected by that in this litigation.

Speaker 5

That doesn't mean that we don't take it seriously. We do take it very seriously. And as I said, we have a great team that's working on it. The last thing, maybe the last two things. There are a number of amicus briefs that have been filed.

Speaker 5

Those are all publicly available. This is in the California state litigation that I would encourage you to read. I think there are 4 or 5 amicus Briefs that really speak to how different this cause of action is relative to what you would typically expect to see in a case. And then finally, on The charge, no, we have not taken a charge. And as I said, we feel very strongly about the merits of our case and look forward to proceeding with the litigation over the coming months years.

Speaker 5

Sue, good question. Thank you.

Speaker 1

Amber, may we go to our last question, please?

Operator

Our last question comes from Geoff Meacham with Bank of America. Geoff, your line is now open.

Speaker 10

Great. Afternoon, guys. Thanks for the questions. And, Merdette, I want to follow-up on a few questions that you've gotten on long acting HIV. I know it's been tricky to develop a doublet that has a comparable profile to lemicastrovert.

Speaker 10

But is there a mechanism that you have either in house or that you've Seeing an HIV that looks like it's more straightforward to develop long acting. I wasn't sure if integrase would be Better than Duke versus non Duke or something of that category? Thank you.

Speaker 4

Thanks, Jeff. This is Mirdad. Yes, we're I think our chemistry and our virology team do favor the institutes as a class where we believe that we have a better shot at getting to a long acting partner for the capsid inhibitors. So I would say a fair bit of our effort is going into those, but and we are Open to looking at a variety of mechanisms to achieve our goal. We just think that the NCS are more likely to get there.

Speaker 4

I will remind you this may have gone under the radar, but we do have the program where we are looking at the bnAbs. I did mention it in the script. And that does provide us another option for people from a long acting standpoint We're looking at every 6 months potentially there. So, we are pretty open and committed to finding The right partner that will achieve our goals.

Speaker 2

Terrific. With that, this is Dan. I just want to thank all of you for joining And I just wanted to emphasize how we believe our Q3 performance demonstrates the tangible impact of delivering on our strategy. After putting the right foundation in place over the past 3 years, we're now seeing the positive momentum that continues to build. It's an exciting time for the company as we realize our potential to do more to reach further and to help more patients in the communities we serve.

Speaker 2

So I No questions, please reach out to our Investor Relations team. As you know, they're more than happy to help. And thank you for

Powered by Quartr