Earnings Call Transcript - HALO Q3 2023

Operator, Operator

Hello and welcome to the Halozyme Third Quarter 2023 Financial Results Conference Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. I will now turn the conference over to Tram Bui, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Tram Bui, Vice President of Investor Relations and Corporate Communications

Thank you, operator. Good afternoon and welcome to our third quarter 2023 financial and operating results conference call. In addition to the press release issued today after the market close, you can find a supplementary slide presentation that will be referenced during today's call, in the Investor Relations section of our website. Leading the call will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer who will provide an update on our business. And Nicole LaBrosse, our Chief Financial Officer, who will review our financial results for the third quarter 2023. On today's call, we will be making forward-looking statements as outlined on slide two. I would also refer you to our SEC filings for a full list of risks and uncertainties. During the call, both GAAP and non-GAAP financial measures will be discussed. Certain non-GAAP or adjusted financial measures are reconciled with the comparable GAAP financial measures in our earnings press release and slide presentation. I'll now turn the call over to Dr. Helen Torley.

Helen Torley, President and CEO

Thank you, Tram. And good afternoon, everyone. We're very pleased with our third quarter and year-to-date 2023 financial and operating results, which reflect the continued strength and durability of our business. We remain focused on supporting our growth trajectory and are well-positioned for another record year. We are on track to meet our recently updated revenue guidance and deliver greater than 25% revenue growth for the year, including greater than 23% royalty revenue growth. I'm also pleased to announce that as a result of our operational performance and close attention to expenses, we are raising EBITDA and non-GAAP EPS guidance. EBITDA guidance has increased from $420 million to $440 million to $430 million to $445 million. And non-GAAP EPS guidance from $2.65 to $2.75 to $2.70 to $2.80. I'm pleased to forecast a strong performance on both top and bottom line growth this year. Moving to slide three. In addition, today we announced an acceleration of the $250 million share repurchase remaining under the approved $750 million share repurchase plan that we announced in 2021. This $251 million share repurchase will be executed through an accelerated share repurchase with a financial institution this week, subject to market conditions. We have a disciplined and balanced capital allocation strategy at Halozyme, investing to grow the business, return capital to shareholders through share repurchases, and seek new growth opportunities through M&A. Our investments grow the business in 2023 have resulted in substantial accomplishments, including our high-volume auto injector. We plan to invest at similar levels to grow the business in 2024. Our balance sheet is strong with continued projected EBITDA growth and cash generation throughout 2023. We have reduced our net leverage substantially and consistently each quarter from 3.2 times at the end of 2022 to 2.4 times at the end of the third quarter of this year. Given our strong balance sheet, decreasing leverage, and continued EBITDA and cash generation, we decided to implement the announced $250 million ASR using cash on hand. As we believe Halozyme is trading at a significant discount to our valuation, making share repurchases a high return on investment opportunity. We will continue to seek growth opportunities through M&A and have increased our technical search and evaluation due diligence capabilities with the addition of Manuel Sanchez-Felix, who is a renowned leader in drug delivery technology and a prior senior fellow of novel drug delivery technologies at the Novartis Institute for Biomedical Research. At this time, we do not project any near-term M&A transactions that would add to our leverage. I would note the highlights in the third quarter which are shown on slide four. We reported total revenue of $216 million, which gives us confidence to achieve our full year revenue guidance of $825 million to $845 million, representing greater than 25% year-over-year growth. With operating expense management being a strong focus in 2023 and with EBITDA and non-GAAP EPS trending to above the lower end of our recently updated guidance, today we increased guidance on these key measures of profitability. Moving now to slide five. As an industry-leading drug delivery platform company, Halozyme has built a diversified and robust portfolio. Our ENHANZE technology combined with an innovative high-volume auto injector provides new and potentially improved therapeutic solutions for patients, our partners, and health care providers. Throughout the year, our ENHANZE partners have made significant progress with their commercialization and development activities, which are expected to result in strong and durable, long-term revenue growth for Halozyme. Before I provide additional details on each project, let me summarize the strong performance and momentum in the quarter, which is delivering strong results today while also advancing new waves of growth for Halozyme in the coming years. Our Wave 2 product DARZALEX FASPRO and Phesgo remains strong revenue drivers. The approval of organics is VYVGART Hytrulo in the United States and Tecentriq subcutaneous in Great Britain increases the total number of commercial products to seven and importantly signals the start in 2023 of two new royalty revenue streams. The positive Phase III data for VYVGART Hytrulo in CIDP will, upon approval, expand the commercial opportunity in a condition where there is significant high unmet need today. And the recent positive data announcements from two additional Wave 3 products Nivolumab subcu and Ocrelizumab subcu support near-term regulatory filings and commercial launches in the '24 to '25 timeframe. I'll leave you with two key takeaways. Firstly, the multiple positive Phase III data readouts from our Wave 3 product in the last 19 months support a high success rate in the translation of Phase I, II ENHANZE subcutaneous pharmacokinetic data into positive Phase III results. This high success rate from early clinical data to positive Phase III data to approval is not always fully appreciated. The likelihood of success for our partners utilizing ENHANZE technology when bridging from an ID approval to subcu is very high, once the early clinical data is generated. And secondly, as a result of the multiple positive Phase III data readouts, we are confident to project nine royalty revenue-generating products by 2025, a significant increase from five that we had as we entered 2023. And moving now to slide six. These approvals are the key drivers of our projects and have the potential to achieve approximately $1 billion in royalty revenue in 2027. Let me now move to slide seven. We set a goal for 2023 to deliver a new ENHANZE deal, a new high-volume auto injector deal, and a new small-volume auto injector deal. We've made strong progress against these goals. We were very pleased to announce a new ENHANZE partnership with Acumen Pharmaceuticals, which reinforces the growing recognition of the value of subcutaneous drug delivery. Acumen is focused on the development of targeted therapies for Alzheimer's disease and is leveraging their deep understanding of the amyloid beta oligomers to usher in a medical breakthrough. The Alzheimer's disease market is a key inflection point with recent unexpected approvals paving a new path for treatment. We are delighted to work with Acumen with the goal of creating a best-in-class subcutaneous delivery option that may ease treatment burden for patients, caregivers, and the healthcare system. Under the terms of our non-exclusive agreement for their proprietary therapy, Halozyme received an upfront payment and will be entitled to milestones, in addition to a single-digit royalty on net sales, reflecting the non-exclusive nature of this agreement. For our high-volume auto injector, we have also made strong progress. We presented the full data from our clinical study, which demonstrated that delivery of 10ml of a representative biologic in 30 seconds with our auto injector was well tolerated by patients and one that patients would have again. The companies we presented the data to have been impressed and view our high-volume auto injector as a breakthrough in the area of rapid auto injection of large volume biologics. This excitement brings some inertia to something new. I am delighted that one of our current partners has agreed to test our current high-volume auto injector device in a clinical test in 2024. This is a step prior to the potential development of a customized high-volume auto injector for the patient population this partner is considering. At least one other current partner is also considering proceeding with the development of a customized high-volume auto injector for their patient population. We have not yet completed this agreement, and our main focus is to seek to get this completed in 2023, recognizing that this may now occur in 2024. As an established leader in rapid subcutaneous drug delivery with ENHANZE and our differentiated auto injector technology, we remain the partner of choice across the industry. We're also seeing strong interest from pharma and biotech companies who are interested in understanding the potential implications of the final CMS guidance on drug price negotiations for Part D drugs. In these guidelines, CMS affirmed guidance that a fixed combination, which includes two or more active ingredients, will be distinct drugs for the purposes of applying the IRA Price negotiation provision. Notably, Halozyme's recombinant human hyaluronidase technology, ENHANZE, has been recognized as an active ingredient by the FDA. With those highlights, I'll now turn to slide eight for an overview of our royalty revenue and a more detailed review of the key products and drivers of growth. Royalty revenue for the third quarter of 2023 increased 15% year-over-year to approximately $114 million and continues to be the key driver of our revenue growth. For the full year, we are reiterating our royalty revenue guidance of $445 million to $455 million, representing greater than 23% growth over 2022. Our Wave 2 product DARZALEX FASPRO and Phesgo are the current royalty revenue growth drivers and will be illustrated on the next two slides. DARZALEX FASPRO is a globally established brand with physicians. Using DARZALEX for multiple myeloma patients maintains a 91% share in the United States and an estimated greater than 80% share outside the United States. With the overall brand performance driven by the use of the subcutaneous formulation, total DARZALEX brand growth is now the key metric we use to measure DARZALEX subcutaneous growth and potential. In the third quarter of 2023, DARZALEX continued to drive strong sales growth for Johnson & Johnson with an increase of approximately 21% year-over-year on an operational basis to approximately $2.5 billion in the quarter. This increase was driven by share gains in all regions and continued growth in the first-line setting. Analysts project annual DARZALEX sales will continue to grow and will reach $17 billion by 2028. Turning now to Roche's Phesgo. Phesgo is the combination of Perjeta and Herceptin delivered in a single five to eight-minute subcutaneous injection for patients with early and metastatic HER-2 positive breast cancer. I'll focus firstly on Perjeta to help dimensionalize the opportunity for Phesgo. For the nine months of 2023, Roche reported Perjeta revenue of CHF3 billion. Moving now to Phesgo. Phesgo sales grew at an impressive 66% to more than CHF800 million, contributing positively to the continued growth of Roche's impressive breast cancer treatment franchise. The global conversion rate from Perjeta to Phesgo continues to increase even as the number of launch countries increases. Phesgo is now launched in 44 countries, up from 38 last quarter, and the conversion rate increased to 37% in the third quarter. Roche anticipates approximately 50% share over time and they noted that the key drivers of uptake include limited nurse and share capacity even in the United States and the pace of preference for subcutaneous administration. Turning now to our Wave 3 products. Our Wave 3 products are now highly derisked with one major market approval and positive Phase III data announced for the remaining three products. Beginning with argenx's VYVGART or efgartigimod. This is argenx's flagship pipeline product and is being developed with ENHANZE and a total of six immune disease indications today, four of which are being developed as subcutaneous only delivery. Analysts predict that efgartigimod will be a multi-billion dollar annual revenue brand by 2028. The launch of argenx's VYVGART and VYVGART Hytrulo with ENHANZE for patients with generalized Myasthenia Gravis is progressing well with growth of 22% quarter-over-quarter to $329 million in the third quarter of this year. With the FDA approval of the subcutaneous version, VYVGART Hytrulo in June of 2023, argenx's goal is to expand the use of VYVGART by offering Myasthenia Gravis patients a new treatment delivery option and to move into earlier lines of treatment driving brand loyalty with their current prescribers. It is exciting that VYVGART Hytrulo is helping argenx achieve their goals. Argenx recently reported that initial feedback from doctors on VYVGART Hytrulo is broadly positive, and they recognize the benefit of the simple 30 to 90 second subcutaneous injection which is enabled by our ENHANZE technology. Hytrulo is contributing to argenx's expansion of the market with new prescribers, with the majority of patients on Hytrulo being VYVGART naive. Argenx is also making progress reaching more Myasthenia Gravis patients globally. In September, VYVGART Hytrulo received a positive opinion from the CHMP signaling a path for European approval for generalized Myasthenia Gravis with a self-administration label later this quarter. Expanding the potential opportunity, Argenx announced positive top-line data from the adhere study evaluating VYVGART Hytrulo with ENHANZE for CIDP. With the 61% reduction in risk of relapse versus placebo, the safety and tolerability profile were reported to be consistent with the confirmed safety profile of VYVGART when used in other indications. There is a significant unmet need in CIDP, and we're excited that Argenx will be filing for their priority review and are preparing for a 2024 launch. And further expanding the opportunity, Argenx recently confirmed two additional study readouts for VYVGART Hytrulo with ENHANZE: the first in idiopathic thrombocytopenia, which is expected in the fourth quarter, and the second in pemphigus, which is expected around the end of the year. I'll move now to our additional products with Roche. The Great Britain approval of Roche's Tecentriq subcutaneous with ENHANZE in August signifies another commercial product approval. Based on the pivotal study conducted in non-small cell lung cancer, Tecentriq subcutaneous was approved in Great Britain for all current IV indications, including certain types of lung, bladder, breast, and liver cancer. Halozyme's ENHANZE drug delivery technology allows for an approximate seven-minute subcutaneous delivery, which compares with 30 to 60 minutes for the IV infusion. Most commented on their recent quarterly call that they project the potential for Tecentriq subcu adoption in resource-constrained markets to mirror the rapid conversion and high share attainment of Phesgo. With regard to upcoming regulatory actions, Roche projects the CHMP opinion in the fourth quarter of 2023 and a U.S. approval decision in 2024. We're also pleased to note that as an IV treatment, Tecentriq continues to demonstrate strong growth. Year-to-date 2023, Roche reported IV Tecentriq revenues of CHF2.8 billion, an increase of 11% year-over-year. I'll move now to OCREVUS. Roche's Phase III Ocarina II trial evaluating OCREVUS subcutaneous with ENHANZE met its primary and secondary endpoints. This opens up the potential for people living with multiple sclerosis to receive their treatment in just 10 minutes twice a year and creates the possibility to administer OCREVUS in additional multiple sclerosis centers that do not have IV infrastructure or a capacity constraint. In October, Roche announced additional data showing that the subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeks. Of note, the OCREVUS subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B cells and memory lesion activity in the brain over 24 weeks. The safety profile of OCREVUS subcutaneous was reported to be consistent with the well-established safety profile of the OCREVUS IV infusion. The Ocarina II data will be submitted to health authorities around the world with U.S. and European launches expected in 2024. OCREVUS in the IV formulation continues its impressive growth trajectory. For the nine months year-to-date, Roche reported OCREVUS revenues of CHF4.8 billion, which represents an increase of 14% year-over-year. Moving to our fourth Wave 3 product with positive Phase III data: Bristol Myers Squibb's subcutaneous Nivolumab. BMS recently reported positive top-line data from the Phase III CheckMate 6070 study which is evaluating Opdivo subcutaneous in advanced or metastatic renal cell carcinoma. The study met its co-primary pharmacokinetic endpoints and key secondary endpoints, demonstrating non-inferiority of objective response rate versus IV Nivolumab. The safety profile of subcutaneous Opdivo was described by BMS as consistent with that of the IV Opdivo. On the recent quarterly call, BMS management indicated that Opdivo subcutaneous has the potential to open up regulatory approvals in indications that constitute 65% to 75% of the Opdivo business today. Importantly, they further commented that subcutaneous has the potential to expand the franchise durability into the 2030s. BMS reported IV sales of Opdivo of $2.3 billion in the third quarter of 2023, an increase of 11% year-over-year. In total, these Wave 3 products represent substantial near-term new royalty revenue opportunities for Halozyme, with analyst projections for total product sales of approximately $35 billion by 2028. What is exciting, and something that I think is very important to highlight, is that this $35 billion projected opportunity is significantly higher than the $20 billion opportunity projected for our Wave 2 products, those that are driving the strong royalty revenue growth we see today. We now move to slide 12, and I'll touch on some highlights from our Wave 4 partner product development pipeline with ENHANZE. Our longer-term growth trajectory is supported by these Wave 4 products with potential launches in the 2025 to 2027 timeframe and the potential to add multiple sustainable new royalty revenue streams. Wave 4 is comprised of 10 partner products, two of which are progressing in Phase III study and one in a recent advancement into a Phase IIb study. The remaining products are in ongoing Phase I clinical testing or have completed Phase I study. The two most advanced Wave 4 products are approved as products and are in Phase III subcutaneous study. These are Johnson & Johnson subcutaneous formulation of Amivantamab and BMS's fixed-dose combination of Nivolumab and Relatlimab with ENHANZE. Notably, Johnson & Johnson presented strong data at ESMO from the Mariposa study demonstrating that the regimen of Amivantamab and Lazertinib, the same regimen that's being studied in a subcu versus IV study, reduced the risk of progression and death by 30% compared to Osimertinib or TAGRISSO. Overall survival data is awaited. Continuing the program, we've recently initiated enrollment of our Phase IIb study which is comparing the efficacy, safety peak and tolerability of N6 with ENHANZE, which is given in combination with Cabotegravir and comparing that to the standard of care in adults with HIV. Turning now to slide 13. We recently presented the positive clinical data result of our high-volume Auto-Injector study at the 13th Annual Port Conference. There was strong interest in the data, which demonstrates the feasibility of administering a subcutaneous injection of 10ml of a representative biologic immune globulin 10% with ENHANZE in approximately 30 seconds using our high-volume auto injector. We're pleased by the acknowledgment by partners and potential partners that this is a breakthrough in terms of rapid, large-volume subcutaneous drug delivery via Auto-Injector. We're also delighted with the progress we've been making in advancing with two current partners. I'll turn now to our commercial portfolio. XYOSTED is a weekly virtually painless subcutaneous testosterone replacement treatment, which is delivered by our proprietary Auto-Injector. Our strategy is to convert patients who are not achieving their treatment goals with intramuscular injections of testosterone replacement therapy. XYOSTED demand in the third quarter continued to grow contributing to a 32% increase in year-to-date demand growth this year compared to 2022. We're on a positive trajectory to achieve approximately $100 million in XYOSTED sales in 2022, representing a 20% increase from the run rate following the acquisition. And then a further update, we recently made the decision to terminate the TLANDO licensing agreement and return the license to licensing effective January 31, 2024. This decision was made due to the inability to obtain economically acceptable coverage with pharmacy benefit managers. We'll now focus all of our promotional sales and marketing activity on driving XYOSTED growth. With that, I will turn the call over to Nicole, who will discuss our financial results for the third quarter of 2023.

Nicole LaBrosse, CFO

Thank you, Helen. Our financial performance in the third quarter sets us up well for another record year. We achieved top and bottom line growth in line with our plan in supporting our financial performance expectations for the full year. Our balance sheet remains strong with continued projected EBITDA growth and cash generation in 2023 and beyond. Our cash, cash equivalents and marketable securities were $483.3 million as of September 30, 2023, compared to $348.3 million as of June 30, 2023. Our net leverage ratio is 2.4 times as of September 30, 2023 compared to 2.9 times as of June 30, 2023. We expect to continue to decrease net leverage with EBITDA growth. Turning to slide 14. And as Helen mentioned, today we announced an acceleration of the $250 million of share repurchases remaining under the approved $750 million share repurchase plan announced in 2021. The $250 million share repurchase will be conducted under an ASR. This brings our total share buyback since the inception of the first program in 2019 to $1.3 billion, which has benefited the current quarter non-GAAP EPS by $0.15. Given our strong balance sheet, decreasing leverage, and continued EBITDA and cash generation, we decided to implement the $250 million ASR now to take advantage of the buying opportunity. We will continue to have a disciplined and balanced focus on our capital allocation efforts, with a focus on driving value for shareholders through investing to grow the business, returning capital to shareholders, and seeking new growth opportunities through M&A with no near-term plans to add to our leverage. Turning now to slide 15 for our detailed financial results for the third quarter of 2023. Revenue for the third quarter was $216 million, compared to $209 million in the prior year period. The revenue increase was primarily driven by higher enhanced product sales, royalty growth, and the XYOSTED sales growth, offset by the timing of milestones recognized in the prior year period. Recall that the timing of the milestone for Tecentriq SC in the U.S. with plans for the third quarter is now expected in 2024. Royalty revenue for the quarter was $114.4 million, an increase of 15%, compared to $99.6 million in the prior year period, driven by continued strong uptake of J&J's subcutaneous DARZALEX and both Roche and Phesgo. Research and development expenses for the third quarter were $17.3 million, compared to $16.7 million in the prior year period. SG&A expenses were $35.3 million compared to $34.5 million in the prior year period. The increases are primarily due to an increase in compensation expense. EBITDA in the quarter was $124.6 million, compared to $109.9 million in the prior year period, reflecting the write-off of a contingent liability related to TLANDO. GAAP diluted earnings per share in the quarter was $0.61 and non-GAAP diluted earnings per share was $0.75. Turning now to slide 16. We are reiterating our top line guidance and raising our EBITDA and non-GAAP EPS guidance for the full year 2023. We expect total revenues of $825 million to $845 million, representing growth between 25% and 28% over prior year total revenue. We expect royalty revenue of $445 million to $455 million, an increase of 23% to 26% year-over-year, driven by continued strength in our ENHANZE Wave 2 products, including DARZALEX SC and Phesgo, as well as a full-year Auto-Injector royalty contribution. We now expect EBITDA of $430 million to $445 million, an increase from $420 million to $440 million, representing growth of 37% to 41% over 2022 EBITDA, due to strong expense management and the release of the TLANDO contingent liability. We now expect non-GAAP diluted earnings per share of $2.70 to $2.80, an increase from $2.65 to $2.75, representing an annual growth of 22% to 27%, which reflects our strong year-to-date results in expense management. With that, I'll now turn the call back over to Helen.

Helen Torley, President and CEO

Thank you, Nicole. It has been another strong quarter of execution, significantly advancing our royalty revenue generating portfolio and growth opportunity. We're excited to further expand current and new partner opportunities for ENHANZE and the high-volume Auto-Injector, and we continue to see additional opportunity for growth. I want to thank everyone on the Halozyme team and our partners and collaborators for the strong progress year-to-date. With that, we'd now be delighted to seek your questions. Operator, please open the call for question and answer.

Operator, Operator

Thank you. Your first question comes from the line of Mohit Bansal with Wells Fargo. Your line is open.

Mohit Bansal, Analyst

Thank you for taking my question and congratulations on the progress. I have a two-part question about the Auto-Injector. Can you clarify if it is associated with products that currently use enhanced technology and could be adapted to an Auto-Injector? Additionally, could you explain how long it typically takes to develop Auto-Injector technology from the initial concept to a market-ready product? What is the process and time involved? Thank you.

Helen Torley, President and CEO

Thanks, Mohit. And thanks for those two questions. With regard to the two updates we gave on high-volume auto-injector progress, one partner is moving into a clinical study as a first step before moving forward to the development of a custom auto-injector for one of their patient populations. The second one is also with a current partner who is evaluating moving forward into a development agreement. As those have not advanced sufficiently to sign a deal, I'm unable to provide any additional information, but they are both partners who are very experienced with our ENHANZE technology. With regard to the auto-injector timeline, it actually depends on the product being used. If it is already a subcutaneous product, as an example, this is a very important driver of the timeline. The second factor is what primary container the partner wants to use and is that immediately available. If it's already a subcutaneous product using ENHANZE and the sub-primary container that's available, we estimate the timeline to be around the two-year timeframe. A comparative study needs to be done, stability work needs to be completed, and human factors studies need to be conducted, but we estimate that can be done in about two years. If it's a case of a product that's currently in IV, transitioning to an auto-injector, expect that to follow the same timeline of approximately five years, since it would have to undergo comparability studies to show that the subcutaneous dose is the same as the IV. While that's happening, all of the device development and the device stability and human factor studies can happen in parallel. So two years to five years is a reasonable timeframe, depending on the type of product, Mohit.

Mohit Bansal, Analyst

Thank you very much. Appreciate it.

Operator, Operator

Your next question comes from the line of Michael DiFiore with Evercore ISI. Your line is open.

Michael DiFiore, Analyst

Hi, guys. Thanks so much for taking my question. And congrats on all the progress, especially congrats on today's newly announced deal with Acumen. My first question is, why is this deal non-exclusive? Is the Amyloid beta target still up for grabs from any other manufacturer? If so, would this potential future manufacturer have the option of securing an exclusive deal outside of Acumen, of course? And my second question is regarding subcutaneous OCREVUS. How should we think about the maximum IV to subcutaneous conversion rate in the U.S. assuming that launches next year? I mean, if we think back to rituximab high sellers launch in the EU, Roche adopted a much more proactive biosimilar defense strategy compared to the U.S. and launched high sellers roughly four years prior to biosimilar entry and as a result, the MAX IV to subcutaneous conversion rate in Europe was 60%. Could we expect a similar 60% conversion here in the U.S.? Thank you.

Helen Torley, President and CEO

Thank you for that question, Michael. We actually do have another partner that is confidential who has non-exclusive access to the amyloid beta. In light of that, the opportunity with Acumen was non-exclusive given that we already had someone targeting that non-exclusively. I think that's a good example of how we're able to do non-exclusive deals; we can license to multiple different partners. We are excited to be working with Acumen on their novel approach to address this very dreaded disease, where we're seeing significant advances and supporting the amyloid beta hypothesis as a key mechanism where we may be able to see real benefits for patients. Regarding subcutaneous OCREVUS, what we're hearing from Roche, if you've been listening to the prepared remarks, is that Roche felt that their growth for OCREVUS has been somewhat limited by the lack of infusion capacity both outside the U.S. and in the U.S. and also sites that can support IV infrastructure. With that in mind, Roche is trying to grow the overall market as a primary goal and will also have some transition as we move towards conversion. We expect both dynamics to happen, which is very exciting, as it means that patients living in remote areas or countries lacking access to IV therapies will be able to start on OCREVUS, which is the leading therapy for multiple sclerosis in the U.S. and EU-5. It’s hard to specify the exact conversion rate, but we can take a lesson from FASPRO, which became a significant driver in the growth we've seen. Overall, I think we will witness compelling growth for OCREVUS, offering a 10-minute subcutaneous administration twice a year instead of 3.5 to six hours through IV twice a year, ultimately closer to patients' homes.

Michael DiFiore, Analyst

Super helpful. Thanks so much.

Operator, Operator

Your next question comes from the line of Corinne Jenkins with Goldman Sachs. Your line is open.

Corinne Jenkins, Analyst

Great. Maybe a couple from us. First, could you just talk to us about some of the drivers of the XYOSTED growth this quarter? I think that's pretty meaningful. Are you seeing an inflection, and what pockets are driving that?

Helen Torley, President and CEO

Yes, thanks, Corinne. With XYOSTED, I’d emphasize two main drivers. The first is focusing on converting patients in the physician's office who are failing their intramuscular testosterone therapy to XYOSTED. The second driver involves diligent attention from the office to ensure prior authorizations are completed and that patients are being effectively connected to co-pay assistance and other programs we've implemented. This effort is driving the recent growth we’re seeing, and we believe there's significant upside potential as our strategy matures, especially as we are currently under 5% share of a market dominated by intramuscular testosterone therapy.

Corinne Jenkins, Analyst

Yes. Helpful. Thank you. And maybe one last one from us. It sounds like there are a number of partners that are circling around the auto-injector. What's your sense of what some of the gating factors are and what things they would like to better understand before actually signing on the deal? And what will they be exploring with the studies next year?

Helen Torley, President and CEO

Yes. As I mentioned in the prepared remarks, we’ve had strong interest in our technology, and we've received comments highlighting the innovative breakthrough it represents. With any new innovation, there is a traditional period of inertia. This is what we saw with ENHANZE initially, and now we are noticing a similar pattern with the auto-injector. As we transition our partners into clinical studies, this will help generate additional data, and we’re excited to present it. We're also thrilled to see progress made with partners interested in evaluating these auto-injectors for their patient populations.

Corinne Jenkins, Analyst

Helpful. Thanks.

Operator, Operator

Your next question comes from the line of Jason Butler with JMP Securities. Your line is open.

Jason Butler, Analyst

Hi, thanks for taking the question. Just one on the accelerated buyback. Now that you're wrapping up this buyback, can you talk about how you're thinking about future return of shareholder capital? And I guess put that in the context of your appetite for bringing on new technologies. Thanks.

Helen Torley, President and CEO

Yes, I'll ask Nicole to address that.

Nicole LaBrosse, CFO

Yes, thank you, Jason. As we think about our capital allocation strategy, it remains unchanged. We're focused on the three pillars that we've been focusing on, which are continuing to invest in our current platforms, continuing to return capital to shareholders while taking advantage of the current buying opportunity, and also continuing to seek growth via M&A with a disciplined approach. We implemented the ASR this quarter because there are no near-term plans for M&A, and we wanted to deploy our capital to return value to shareholders, but that will continue to be a focus for us in the longer term as we grow the business.

Jason Butler, Analyst

Great. And then just one more from me on Phesgo. Could you speak to how you think about peak adoption here and whether self-administration could drive further adoption for subcutaneous treatments?

Helen Torley, President and CEO

Yes, thanks, Jason. Regarding Phesgo, Roche's comments indicate that while we're consistently seeing an uptick in conversion rates weekly, it should be noted that the increasing number of launch countries might dilute the overall conversion rate. Hence, the observed 37% conversion reflects a broad range from initial launches to more established markets, many of which are exceeding a 90% conversion rate in Europe. Roche anticipates a target of 50% conversion, and has mentioned that key factors for uptake include reduced nurse and share capacity both in the U.S. and internationally. So we're very pleased with the progress and continual growth, looking to potentially reach the 50% overall conversion throughout the market.

Jason Butler, Analyst

Okay, great. Thank you.

Operator, Operator

Your next question comes from the line of Vikram Purohit with Morgan Stanley. Your line is open.

Vikram Purohit, Analyst

Hi, good evening. Thanks for taking our questions. So we had two. One on capital allocation and one on the auto-injector. Going back to some of your prepared remarks, it sounded like there’s a renewed focus on business development and M&A. While we understand that you're not anticipating any near-term M&A, could you speak generally about the profile of businesses and assets that you would find additive to pull into Halozyme? On the auto-injector, just for clarification, are the economic terms associated with these potential initial contracts in line with the economics associated with your current ENHANZE contracts? Thanks.

Helen Torley, President and CEO

With regard to BD and M&A. As Nicole mentioned, we didn't find any near-term opportunities, but we are continuing to look because that remains one of our three core pillars, which is to seek growth by deploying our capital for M&A. As a leader in drug delivery, we are looking for derisked broadly licensable assets where we can see a path to near-term accretion. So we're searching for any form of drug delivery that major pharma or biotech cannot do themselves and which they would need to license from a company that has that specific asset. There are definitely assets out there to anticipate the question, but these must fit our criteria grid for us, including near-term accretion. We will keep looking. Regarding the high-volume auto-injector, since it has to be used with ENHANZE, strategically, this will help us to expand the number of current partner assets in the clinic and into clinical studies. The auto-injector will necessarily be associated with a royalty payment for the drug and the model for the high-volume auto-injector may involve a development down payment as it's developed along with sales from the created product.

Vikram Purohit, Analyst

Got it. Thank you.

Operator, Operator

Your next question comes from the line of an unidentified analyst with JPM Chase. Your line is open.

Unidentified Analyst, Analyst

Hey, everyone. This is Nason filling in for Jess Fye. I have a question about the non-exclusive deal. Are you noticing increased interest in non-exclusive arrangements from potential partners? I also want to know about the auto-injector. What is the process for turning the auto-injector into one that can be self-administered? The initial Phase I auto-injector still requires administration by a physician. Thank you.

Helen Torley, President and CEO

I will take the one on the auto-injector and maybe ask Nicole to comment afterward on the non-exclusive deals. Because this was a prototype, and it's the first time it’s ever been done to attempt to deliver 10ml in 30 seconds, we thought it was prudent and for patients to have a healthcare administered approach to it. What we will find now is that some partners are likely going to move into self-administration studies. The only thing that needs to be done is to rewrite the protocol that way. It's very simple; a patient simply needs to position the auto-injector on the abdomen, click a button, and hold it there. It’s straightforward for patients at this stage. Hence, the only reason we didn't conduct the first study in this manner was that we wanted to ensure safety. We'll support patient studies. Now, as I mentioned, it seems likely that we'll see partners moving into clinical studies next year. Nicole?

Nicole LaBrosse, CFO

Yes, happy to comment on the non-exclusive deals. Historically, we've always sought to pursue both exclusive and non-exclusive deals. Generally, exclusive deals have garnered more interest in the past, but that tends to come with a higher price tag. We do see the benefits of non-exclusive arrangements, allowing us to reach more partners and ultimately more patients, so both types of models will be part of our strategy.

Unidentified Analyst, Analyst

Thank you.

Operator, Operator

Your next question comes from the line of Mitchell Kapoor with H.C. Wainwright. Your line is open.

Mitchell Kapoor, Analyst

Hi, everyone. Thanks for taking the questions. I wanted to ask about the evolution of the royalty revenue business. Right now, a lot of it is coming from DARZALEX and Phesgo. But we'll see VYVGART Hytrulo and Tecentriq subcutaneous making up more of the revenue share. Could you comment on how soon you expect meaningful uptake to occur for these agents? And then also, on Tecentriq’s subcutaneous approval in 2024, can you comment on when you have a new PDUFA date, or what are the gating items to getting to that timeline?

Helen Torley, President and CEO

With regard to the evolution, thank you for asking because we're very excited that the Wave 3 products are now all four of them largely derisked; with one approval and three positive Phase III studies, which is looking very encouraging. We anticipate launches of these four products in the 2023 to 2025 timeframe. As I mentioned, if you look at these products projected sales by 2028, that'll reach $35 billion, which is substantially higher than the $20 billion we're currently seeing with DARZALEX and Phesgo. All four products will be commercialized by 2025, with several launching in the time frame of 2024, 2025, and further to 2027. So certainly, there's a nice addition to the revenue potential alongside the continued contributions from Wave 1 and Wave 2 products. As for Tecentriq, they haven't communicated any assigned date yet, but they stated that the filing would go in by year-end this year and assuming a standard 10-month review time, it can be estimated in the September-October timeframe.

Mitchell Kapoor, Analyst

Okay, great. Thank you all very much.

Helen Torley, President and CEO

Thank you.

Operator, Operator

That is all the time we have for the question-and-answer session. This will conclude today's conference call. We thank you for joining. You may now disconnect your lines.