Halozyme Therapeutics - Q3 2023

Transcript

Operator (participant)

Hello, and welcome to the Halozyme Q3 2023 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question during this time, simply press star one on your telephone keypad. I will now turn the conference over to Tram Bui, Vice President of Investor Relations and Corporate Communications. Please go ahead.

Tram Bui (VP of Investor Relations and Corporate Communications)

Thank you, operator. Good afternoon, and welcome to our Q3 2023 financial and operating results conference call. In addition to the press release issued today after the market closed, 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 Q3 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 Q3 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 we're well positioned for another record year. We are on track to meet our recently updated revenue guidance and delivered greater than 25% revenue growth for the year, including greater than 23% royalty revenue growth. I am 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-$440 million to $430 million-$445 million, and non-GAAP EPS guidance from $2.65-$2.75 to $2.70-$2.80. I'm pleased to forecast that 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 $250 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 to 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 3.2x at the end of 2022 to 2.4x at the end of the Q3 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 repurchase 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 Institutes for BioMedical Research. At this time, we do not project any near-term M&A transactions that would add to our leverage. I'll move now to highlights in the Q3, which are shown on slide four.

We reported total revenue of $260 million, which gives us confidence to achieve our full-year revenue guidance of $825 million-$845 million, representing greater than 25% year-over-year growth. With operating expense management a strong focus in 2023, and with EBITDA and non-GAAP EPS trending above the low 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 enhanced technology, combined with an innovative high-volume auto-injector, provides new and potentially improved therapeutic solutions for patients, our partners, and healthcare providers. Throughout the year, our enhanced 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 product, 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 lead two products, DARZALEX FASPRO and PHESGO, remain strong revenue drivers. The approval of argenx's VYVGART Hytrulo in the United States and Tecentriq Subcutaneous in Great Britain increased the total number of commercial products to seven, and importantly, signaled the start in 2023 of two new royalty revenue streams. The positive Phase III data for VYVGART Hytrulo and CIDP will, upon approval, expand the commercial opportunity in a condition where there is significant high unmet need today.

The recent positive data announcements from two additional Wave three products, Nivolumab subQ and Ocrelizumab subQ, support near-term regulatory filings and commercial launches in the 2024-2025 time frame. I'll leave you with two key takeaways. Firstly, the multiple positive Phase III data readouts from our Wave three products in the last 19 months support a high success rate in the translation of Phase I/II enhanced subcutaneous pharmacokinetic data into positive Phase III results. The 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 enhanced technology when bridging from an IV approval to subQ is very high once early clinical data is generated.

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. Moving now to slide six. These approvals are the key drivers of our projection of the potential to achieve approximately $1 billion in royalty revenue in 2027. Let me now move to slide seven. We set the goal for 2023 to deliver a new enhanced deal, a new high-volume auto-injector deal, and a new smaller volume auto-injector deal. We've made strong progress against these goals. We were very pleased to announce a new enhanced 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 at a key inflection point, with recent and expected 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 the treatment burden for patients, caregivers, and the healthcare system. Under the terms of our non-exclusive agreement for their proprietary therapy, Halozyme receives 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 10 mL of a representative biologic in 30 seconds with our auto-injector was well tolerated by patients and one which the patients would have again. The companies we presented the data to have been impressed and view our high-volume auto-injector plus ENHANZE as a breakthrough in the area of rapid auto-injection of a large volume biologic. With any breakthrough comes excitement and 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 remain focused to seek to get this completed in 2023, recognizing 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 its guidance that a fixed combination, which included 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 Q3 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're reiterating our royalty revenue guidance of $445 million-$455 million, representing greater than 23% growth over 2022. Our Wave 2 products, DARZALEX FASPRO and PHESGO, are the current royalty revenue growth drivers and will be illustrated on the next two slides.

DARZALEX FASPRO is the globally established choice of physicians using DARZALEX for multiple myeloma patients, with 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 subcutaneous formulation, total DARZALEX brand growth is now the key metric we use to measure DARZALEX subcutaneous growth and potential. In the Q3 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 be $17 billion by 2028.

Turning now to Roche's PHESGO, which is shown on slide 10. PHESGO is a combination of Perjeta and Herceptin, delivered in a single five to eight-minute subcutaneous injection for patients with early and metastatic HER2-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 CHF 3 billion. Moving now to PHESGO, PHESGO sales grew an impressive 66% to more than 800 million CHF, 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 launched countries increases. PHESGO is now launched in 44 countries, up from 38 last quarter, and the conversion rate increased to 37% in the Q3.

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 patient preference for subQ. Turning now to our Wave-three products shown on slide 11. I'll touch on recent event highlights and also upcoming value-driving events to watch for. All Wave 3 products are now highly de-risked, 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 in a total of six autoimmune disease indications to date, with four of these indications being developed as subcutaneous-only delivery. Analysts project that efgartigimod will be a multi-billion dollar annual revenue brand in 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 Q3 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 goal. Argenx recently reported that initial feedback from doctors on VYVGART Hytrulo is broadly positive, and they recognize the benefit of this 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 for VYVGART 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 a 61% reduction in risk of relapse versus placebo, the safety and tolerability profile were reportedly 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 with their priority review voucher and are busy preparing for a 2024 launch.

Further expanding the opportunity, argenx recently confirmed two additional study readouts for VYVGART Hytrulo with ENHANZE. The first in idiopathic thrombocytopenic purpura, which is expected in the Q4, 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 marked our seventh ENHANZE 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 7-minute subcutaneous delivery, which compares with 30-60 minutes for the IV infusion.

Roche commented on the 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 Q4 of 2023 and 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 CHF 2.8 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 endpoint, opening up the potential for people living with multiple sclerosis to receive their treatment in just 10 minutes twice a year.

creating the possibility to administer OCREVUS in additional multiple sclerosis centers that do not have IV infrastructure or that have IV capacity constraints, which adds a new growth opportunity. In October, Roche announced additional data showing subcutaneous injection was non-inferior to intravenous infusion based on OCREVUS levels in the blood over 12 weeks. Of note, OCREVUS subcutaneous injection was comparable to IV infusion in providing rapid and sustained depletion of B-cells and near complete suppression of MRI 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. The OCREVUS in the IV formulation continues its impressive growth trajectory.

For the nine months year to date, Roche reported OCREVUS revenue of CHF 4.8 billion, which represents an increase of 14% year-over-year. Moving to our fourth wave three product with positive Phase III data, that's Bristol-Myers Squibb, subcutaneous nivolumab. BMS recently reported positive top-line data from the Phase III CheckMate-67T study, which is evaluating Opdivo subcutaneous in advanced or metastatic renal cell carcinoma. The study met its co-primary pharmacokinetic endpoint and a key secondary endpoint, 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 our regulatory approvals in indications that constitute 65%-75% of the Opdivo business today.

Importantly, they further commented that subcutaneous has the potential to extend the franchise durability into the 2030s. BMS reported IV sales of Opdivo of $2.3 billion in the Q3 of 2023, an increase of 11% year-over-year. In total, these wave three products represent substantial near-term new royalty revenue opportunity for Halozyme, with analyst projections for total product sales of approximately $35 billion by 2028. What is exciting, and something that is I think, very important to highlight, is that this $35 billion projected opportunity is significantly higher than the $20 billion opportunity, which is projected for our wave two products, those that are driving the strong royalty revenue growth we see today. I'll move now to slide 12, and where I'll touch on some highlights from our wave four partner product development pipeline with ENHANZE.

Our longer-term growth trajectory is supported by these wave four products, with potential launches in the 2025-2027 time frame, and the potential to add multiple, sustainable, new royalty revenue streams. Wave four comprise of 10 partner products, two of which are progressing in Phase III studies and one 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 four products are approved as IV products and are in Phase III subcutaneous studies. These are Johnson & Johnson's subcutaneous formulation of amivantamab and BMS's fixed-dose combination of nivolumab plus relatimab 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 the subQ versus IV study, reduced the risk of progression and death by 30% compared to osimertinib or Tagrisso. Overall survival data is now awaited. Continuing the program, we've recently initiated enrollment of a Phase II B study, which is comparing the efficacy, safety, PK, and tolerability of N6LS 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 results of our high-volume autoinjector study at the 13th Annual PODD Conference.

There was strong interest in the data, which demonstrates the feasibility of administering a subcutaneous injection of 10 mL of a representative biologic, immunoglobulin 10% with ENHANZE, in approximately 30 seconds using our high-volume autoinjector. We're pleased by the acknowledgment by our partners and potential partners that this is a breakthrough in terms of rapid, large volume, subcutaneous drug delivery via autoinjector, and 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 autoinjector. Our strategy is to convert patients who are not achieving their treatment goals with intramuscular injections of testosterone replacement therapy. XYOSTED demand in the Q3 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 2023, representing a 20% increase from the run rate following the acquisition. In a further update, we recently made the decision to terminate the TLANDO licensing agreement and return the license to Lipocine, effective January 31st, 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 activities on driving XYOSTED growth. With that, I'll turn the call over to Nicole, who will discuss our financial results for the Q3 of 2023. Nicole?

Nicole LaBrosse (CFO)

Thank you, Helen. Our financial performance in the Q3 sets us up well for another record year. We achieved top and bottom-line growth in line with our plans and supporting our financial performance expectations for the full year. Our balance sheet remains strong, with continued prospective EBITDA growth and cash generation in 2023 and beyond. Our cash, cash equivalents, and marketable securities were $483.3 million as of September 30th, 2023, compared to $348.3 million as of June 30th, 2023. Our net leverage ratio is 2.4x as of September 30th, 2023, compared to 2.9x as of June 30th, 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 $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 this 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, shareholder return, 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 Q3 of 2023. Revenue for the Q3 was $216 million, compared to $209 million in the prior year period. The revenue increase was primarily driven by higher ENHANZE product sales, royalty growth, and 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. was planned for the Q3 and 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, as well as Roche's PHESGO. Research and development expenses for the Q3 was $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-$845 million, representing growth between 25%-28% over prior year total revenue. We expect royalty revenues of $445 million-$455 million, an increase of 23%-26% year-over-year, driven by continued strength in our ENHANZE products, including DARZALEX SC and Phesgo, as well as a full-year auto-injector royalty contribution.

We now expect EBITDA of $430 million-$445 million, an increase from $420 million-$440 million, representing growth of 37%-41% over 2022 EBITDA, due to strong expense management and the release of a TLANDO-related contingent liability. We now expect non-GAAP diluted earnings per share of $2.70-$2.80, an increase from $2.65-$2.75, representing annual growth of 22%-27%, which reflects our strong year-to-date results and 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 take your questions. Operator, please open the call for question and answer.

Operator (participant)

Thank you. If you have a question, please press star one on your telephone keypad. To withdraw your question, simply press star one again. Your first question comes from the line of Mohit Bansal with Wells Fargo. Your line is open.

Mohit Bansal (Managing Director and Senior Biotech and Pharmaceutical Analyst)

Great. Thank you very much for taking my question, and congrats on all the progress. I have a two-part question regarding the auto-injector. So, the partner you mentioned, or who is looking at auto-injector, could you help us understand, is it related to, like, someone who—so, is it for a product which already is using enhanced technology and that now could be converted into an auto-injector, something like that? And then the other part of the question is, could you help us understand how much time does it take for an auto-injector technology, like, when someone conceptualizes that, to actually converting it into a real product? What is the process there? How much time does it take? Thank you.

Helen Torley (President and CEO)

Thanks, Mohit, and thanks for those two questions. With regard to the two updates we gave on the high-volume auto-injector progress, one partner 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. And the second one, which is also a current partner, who's evaluating moving forward into a development agreement. As those have not advanced sufficiently for us to sign the deal, I am unable to provide any additional information, but they are both partners who are very experienced with our enhanced technology. With regard to the auto-injector timeline, the high volume one, it is going to depend actually on what the product is that's being used. Is it already a subQ?

As an example, is a very important driver of the timeline. And the second one is what primary container the partner wants to use, and is that immediately available? If it's already a subcutaneous product using ENHANZE and a subprimary container that's available, we estimate the timeline in around the two-year timeframe. Needs to be a comparative study done, stability work needs to be done, human factor studies need to be done, but we estimate that can be done in about two years. And that, as you see, starts to generate revenues for Halozyme.

If it's the case of a product that's currently in IV, and this is going to be something that is adding ENHANZE and going into an auto-injector, think of that more like the timeline we see for an ENHANZE product, because, that, which is approximately five years, 4.5-5 years, from first in human to approval. That really would have to go through the comparability to show that the subQ dose is the same as IV. And while that's happening, all of the device development and the device stability and the human factor studies can happen in parallel. So two to five years, I think, is a reasonable timeframe, depending on the type of product, Mohit.

Mohit Bansal (Managing Director and Senior Biotech and Pharmaceutical Analyst)

Thank you very much. Appreciate it.

Operator (participant)

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

Michael DiFiore (Managing Director of Biotechnology & Pharmaceuticals/Major Equity Research)

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 a-beta target still up for grabs from any other manufacturer? And 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 subQ OCREVUS. How should we think about the maximum IV to subQ conversion rate in the U.S., assuming that launches next year? I mean, if we think back to Rituxan Hycela's launch in the EU, Roche adopted a much more proactive biosimilar defense strategy compared to the U.S. and launched Hycela roughly four years prior to biosimilar entry.

As a result, the max IV to subQ conversion rate in Europe was 60%. I guess my ultimate question is: could we expect a similar 60% conversion here in the U.S.? Thank you.

Helen Torley (President and CEO)

Right. Thank you for that question, Michael. We actually do have another partner that is confidential, who has the non-exclusive access to the amyloid beta. And in light of that, the opportunity with Acumen was non-exclusive, given that we already had somebody who has the target non-exclusively. And I think that's a nice example as to how, when we're able to do non-exclusive deals, we can license to multiple different partners. So I think that answered that question, and, you know, we're excited to be working with Acumen on their novel approach to this very dreaded disease, where we're seeing significant advances and support all of the amyloid beta hypothesis as a key mechanism where we may be able to see real benefits for patients.

With regard to subcutaneous OCREVUS, what we're hearing from Roche, if you've been listening to their prepared remarks, is Roche has felt that their growth of their OCREVUS has been a little limited by the lack of infusion seat capacity, both outside the U.S. and in the U.S., and also sites who are able to have IV infrastructure. In light of that, there's a lot of commentary from Roche to think about this a little bit like FASPRO became after the conversion was done, which is they're going to be trying to grow the overall market as a primary goal, and also have some switch. But it's going to be a little bit of a different dynamic than the one you mentioned for Rituxan Hycela, where it was switched before biosimilars.

I think we're going to see both dynamics happening. We're very excited by that because it means that patients who are living far away and have poor access, such as patients in rural communities or countries where there isn't good access to IV therapies, are going to be able to start on OCREVUS, which is the leading therapy for multiple sclerosis in the U.S. and EU5. So, we'll see a market growth strategy and a conversion strategy, and because we haven't seen exactly this dynamic happen before, it's hard to say exactly how much conversion will happen. But we certainly are seeing for FASPRO, if I can turn your attention to that, that the availability of FASPRO is what's been fueling the dramatic growth we're seeing of DARZALEX in the last couple of years.

And it's what's projected to be taking DARZALEX from an $8 billion brand last year to a $16 billion brand next year. So new way to think about it, but I think equally exciting in terms of the opportunity we're going to see here for OCREVUS, where it'll be 10 minutes sub Q, two times a year, instead of 3.5-6 hours IV twice a year, and very likely closer to the patient's home.

Nicole LaBrosse (CFO)

Super helpful. Thanks so much.

Operator (participant)

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

Corinne Jenkins (VP of Global Investment Research)

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

Helen Torley (President and CEO)

Yes, with -- thanks, Corinne. With XYOSTED, we did a focus on two drivers. First one is driving that conversion in the physician's office to get the patients identified who are not doing well on their IM XYOSTED and getting them onto, sorry, their IM testosterone therapy and getting them onto XYOSTED. And the second one is very careful attention in the office to make sure the office is filling in any prior authorizations that might be required. But also making sure when the patient gets the prescription filled, they're being more successfully connected with the copay assistance and other programs we've put in place.

So it's that pull-through of all of the programs and a higher rate of identification of patients that really is driving the growth that we're seeing. And we do predict, you know, we're still under 5% share of this overall market, which is dominated by the IM therapy, which is our conversion target. That's what we're trying to switch patients from. So a lot of growth still to come with that, the strategy that is beginning to really pay dividends.

Corinne Jenkins (VP of Global Investment Research)

Yeah, helpful. Thank you. Maybe one last one from us. It sounds like there's a number of partners that are kind of circling around the auto injector. What's your sense of some of the gating factors or things they'd 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)

Yeah, as I mentioned in the pre-prepared remarks, really, when we've been presenting it, we've had, you know, comments like, "Fantastic, breakthrough. I never thought this was possible." And I think it is the degree of innovation that's represented here, Corinne, that, like with any new innovation, there is always a period of inertia. And we'll see it's exactly what we saw with ENHANZE. If I go back to, you know, right when I was in the company and when we'd just done a couple of the deals, it took a couple of companies to come in and do it, and then the wave happened, after that.

So I think we're just seeing that, you know, traditional innovation adoption curve, and you know, people moving into the clinic now to test it is going to help generate additional data. And just because it was so remarkable, we showed them a video of patients receiving the therapy, and it's invisible to see that the patient had received 10 mL into the abdomen, I think, in just 30 seconds. So I think it's a wonderful reflection of the innovation, and people are doing their work now to evaluate that, think about it for their patients' populations, and in the case of one partner I mentioned, moving into a clinical study next year. So we're going to see more of that, over the next months, I believe.

Corinne Jenkins (VP of Global Investment Research)

Helpful. Thanks.

Operator (participant)

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

Jason Butler (Managing Director of Biotechnology Equity Research)

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

Helen Torley (President and CEO)

Yeah, I'll ask Nicole to address that.

Nicole LaBrosse (CFO)

Yeah. Thanks, Jason. So as we think about our capital allocation strategy, it really remains unchanged. We're focused on the three pillars that we've been focused on, which is really continuing to invest in our current platforms, continuing to return capital to shareholders, and we're very excited to take advantage of this buying opportunity now and accelerate the remaining portion on the current plan to do that, starting this quarter. And then also, again, very much continuing to look for growing that revenue growth that durability long term via M&A. We implemented the ASR this quarter because there are no near-term plans to grow via M&A, and we wanted to deploy our capital in the best way to return value to shareholders. But that will very much continue to be a focus in the longer term as we grow the business.

Jason Butler (Managing Director of Biotechnology Equity Research)

Great. Then just one more for me on PHESGO. Can you just speak to how you think about, you know, peak adoption here and how the self-administration product could drive -- whether it could drive further adoption for the subcu?

Helen Torley (President and CEO)

Yes, thanks, Jason. On PHESGO, you know, on Roche's comments, you know, obviously, what we're seeing every quarter is an increase in the overall conversion. But I'll just mention that every quarter there's always 4-6 countries being added, which is diluting the overall conversion. So that 37%-38% reflects a range from very recent start of conversion up, all the way up to, I think they've mentioned 92% conversion in Europe. With U.S. based on latest comments maybe two quarters ago, at 20% at that time. Roche has commented that they expect up to get to 50% conversion. With that obviously continuing to be a range of recently launched markets and also high conversion in those markets where we're seeing resource constraints, nursing shortages, IV capacity constraints.

And so, we're obviously delighted with the very strong progress we're seeing and the continuous growth to come, as we get to that 50% overall conversion of the market. And, you know, I wouldn't be surprised myself if it was able to go even further than that, based on the value proposition that we're seeing here. And just to reiterate that, for breast cancer patients, many of them moms, many of them working, instead of having to be an infusion center for the treatment, which can take up to one and a half hours, but then there's the observation. The injection of PHESGO is given in just five minutes or so, with a shorter observation time.

That means a mom can go in before work, at lunchtime, after work, and not have to take so much time. So, it's a strong value proposition, and I am expecting more growth to come. The focus of the On-Body, which does include PHESGO, so sometimes people ask, "Is that got ENHANZE in it?" Yes, ENHANZE is an intrinsic part of PHESGO, which also included Herceptin and Perjeta. The goal with that is to allow for more at-home therapy. And so I haven't heard Roche comment if that – how much they think that'll impact the growth of market.

But, based on the patient population we just described, I think this is going to be a very nice option for a certain segment of that population who that will fit better into their lifestyle.

Jason Butler (Managing Director of Biotechnology Equity Research)

Okay, great. Thank you.

Operator (participant)

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

Vikram Purohit (Research Analyst Biotechnology and Specialty Pharmaceuticals)

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

Helen Torley (President and CEO)

All right. 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 through deploying our capital for M&A. As a leader in drug delivery, we are looking for de-risked, broadly licensable assets, where we can see a path to near-term accretion. So some form of drug delivery that is something major pharma, major biotech cannot do themselves, and which they would be needing to license from a company that has that specific asset. There are assets out there to anticipate that question. It just has to fit a grid of criteria for us, including that path to near-term accretion. So, we'll keep looking.

We spent a number of years looking for the Antares acquisition, and so, we will just keep focusing on that. But also, as Nicole mentioned, what we consider to be the undervaluation of the Halozyme stock made the share repurchase the right thing, we believe, to return capital to shareholders, given the strong opportunity that that represented. With regard to the high-volume auto-injector, what we're going to see is because the high-volume auto-injector has to be used with ENHANZE, strategically this is positioned to help us expand the number of current partner assets in the clinic and moving into the clinic, but also to allow us to find more ENHANZE partnerships. So the HVI is always going to be associated with a royalty payment for the drug.

But that is primarily going to be driven by ENHANZE. And the model that's most likely for the high-volume auto injector will be development payment as it's being created. But then, product sales, where we would make money on the number of devices that were purchased in the sale of the created product.

Vikram Purohit (Research Analyst Biotechnology and Specialty Pharmaceuticals)

Got it. Thank you.

Operator (participant)

Ladies and gentlemen, if you have a question, it is star one. Your next question comes from the line of Na Sun with J.P. Morgan. Your line is open.

Na Sun (VP of Global Tech Strategy)

Hey, guys, this is Na Sun for Jessica Fye. Question on the non-exclusive deal. I guess... Is there more, are you seeing more interest in non-exclusive deals from potential partners? And then another one on the auto-injector. What is the pathway for developing the auto-injector into a self-administered auto-injector? The first auto-injector, Phase I, is still administered by a physician. Thanks.

Helen Torley (President and CEO)

All right. I will take the one on the auto-injector. Maybe I'll ask Nicole to comment afterwards on the non-exclusive deals. Because this was a prototype, and the first time this had ever been done to attempt to deliver 10 mL in 30 seconds, we thought it was prudent and appropriate for patients that we had a healthcare administered approach to it. What we will find now is that partners are going to be moving, the partner that we mentioned, is likely going to move into the clinic to do a patient self-administered. And frankly, there's nothing additional that has to be done other than to write the protocol that way. It, it's very simple.

It's inject or place the device and the auto-injector on the abdomen and click a button and hold it there. So it's going to be very straightforward for patients to do. But the only reason we didn't do it in the first study was because it's never been done before. Having seen how well tolerated it was and how well it worked, we have no hesitation in supporting patient studies at this stage then. So it'll simply be the patient does that himself. And while this is a larger volume than some other auto-injectors, the actual mechanism of doing it is tried and tested. I'll say tried and tested by it seems like hundreds of thousand patients around the world with GLP-1. It's very similar to that.

It's just a larger volume and a longer hold time.

Na Sun (VP of Global Tech Strategy)

Nicole, do you want to comment on the interest in non-exclusive deals at the moment?

Nicole LaBrosse (CFO)

Yes, happy to, Na. So I'll say, you know, historically, we always have tried to market exclusive and non-exclusive deals. I think historically the interest has been on the exclusive side, but obviously that comes with a higher price tag as well. We're very interested in non-exclusive deals. We see the benefit of reaching more partners and more patients that way. So I think both you'll see coming through, and we'll continue to pursue both types of models.

Na Sun (VP of Global Tech Strategy)

Thank you.

Operator (participant)

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

Mitchell Kapoor (Director and Senior Biotechnology Analyst)

Hi, everyone. Thanks for taking the questions. I wanted to ask about the evolution of the royalty revenue business, and right now we have a lot of it coming from DARZALEX and VYVGART, but obviously, we'll have VYVGART, VYVGART Hytrulo, and Tecentriq subcutaneous and others that'll be making up a little bit more of the revenue, royalty revenue business share. Could you just kind of comment on how soon you expect meaningful uptake to occur for some of these other agents? And then also on the Tecentriq subcutaneous approval in 2024, can you just comment on, you know, when you'll have a new PDUFA date, or what is kind of the gating items to getting to that timeline?

Helen Torley (President and CEO)

Okay. All right. With regard to the evolution, thanks for asking that question, because we're very excited that the wave three products are now, all four of them, largely de-risked, with one approval and three positive Phase III studies. Looking very encouraging for launches of these products in the 2023 to 2025 timeframe. And importantly, as I mentioned, if you look at where these products are projected to be in terms of size by 2028, it's $35 billion in sales of the product, which is substantially higher than the $20 million we're seeing with DARZALEX and PHESGO today. So we're very excited about how attractive that whole opportunity is.

You know, depending on how you define meaningful, all four products are going to be commercialized by 2025, with several of them launching one to two years before that. So, you know, I think, 2024, late 2024, 2025, 2026, 2027 is where we're really going to see these products growing very nicely, following, you know, what we've seen in the past, which has to, maybe a 2.5 to three years to peak conversion. So definitely going to be a very nice addition to the continued contributions from the wave one and wave two products, but adding four new very attractive royalty revenue streams in 2023, 2024, 2025, and then on to 2027 and beyond.

Mitchell Kapoor (Director and Senior Biotechnology Analyst)

Great. Thank you. And on the Tecentriq, you know, new date for potential approval, is that something more narrow that you'll have a timeline on as we get closer to that? Or do we have an assigned date at this point?

Helen Torley (President and CEO)

Yeah. As far as we're aware, Roche has not communicated any assigned date. What they did state was that the filings go in by year-end this year. And assuming a standard 10-month review time, Mitch, I mean, that would take it into, you know, let's say, the September-October timeframe. But Roche has not communicated anything about that as yet.

Mitchell Kapoor (Director and Senior Biotechnology Analyst)

Okay, great. Thank you all very much.

Helen Torley (President and CEO)

Thank you.

Operator (participant)

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.