Halozyme Therapeutics, Inc.

I will now turn the call over to Tram Bui, Halozyme's Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, Operator. Good afternoon and welcome to our fourth quarter and full year 2024 Financial and Operating Results Conference call. In addition to the press release issued today after the market closed, You could 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, Hale-Zyme's President and Chief Executive Officer, who will provide an update in our business, and Nicole Labrosse, our Chief Financial Officer, will review our financial results as well as our outlook. 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 risk 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 will now turn the call over to Dr. Helen Toiley.

Thank you, Tom, and good afternoon, everyone. Our strong fourth quarter results concluded what proved to be an exceptional year for Halazim. I will start by recapping our record-breaking performance in 2024. Total revenue exceeded $1 billion for the first time, growing 22% over prior year. We also raised our financial guidance twice during the year, and I'm pleased to report that four-year results exceeded our raised guidance for royalty revenue, adjusted EBITDA, and non-GAAP EPS. We estimate that 1 million patients have now received drugs delivered subcutaneously with Enhance, establishing an unsurpassed and we believe unsurpassable safety database to inform regulators and new partners. Importantly, multiple impressive milestones were achieved in 2024 that will accelerate our near-term and long-term growth and extend the durability of the royalty revenue streams. Four major products or new indications within HANCE received approval in a major region, adding future growth. Current partners nominated five new targets to advance into the clinic for subcutaneous development, expanding opportunity. We extended the patent protection of Enhanze in Europe out to 2029 with issuance of a new patent with the effect of maintaining our royalty rate for Darzalex subcutaneous and Amivantamab subcutaneous unchanged at the mid single digit rate for the next five years until March of 2029. And we also remain confident in the opportunity for the US patent reissue, which will have the same effect of extending full royalty rate, in this case, from September of 2027 to March of 2029, noting that this is currently not reflected in our five-year financial outlook. This remarkable financial and operational performance, plus our continued business expansion, will deliver strong revenue and earnings growth for many years to come. Moving now to slide four, I'll just call out a few financial highlights before I provide more details on the key business drivers. Our strong fourth quarter performance resulted in record full-year 2024 results. Strong royalty revenue growth of 27% in 2024 resulted in $571 million in royalty revenue, exceeding our raise guidance, and that was the key driver of total revenues exceeding $1 billion. And the strong revenue performance coupled with our careful management of expenses resulted in 2024 net income increasing an impressive 58% year over year to $444 million. As we discussed in January on our 2025 and multi-year guidance call, the momentum and opportunity we have across our business gives us confidence that we are firmly on track to deliver another record year and to meet our targets in 2025 and beyond. I'm pleased to reiterate our 2025 guidance, including for total revenue, where we project $1.15 billion to $1.225 billion, representing growth of 13% to 21% year-over-year. This continued strong growth will be primarily driven by three products, DARS-Lex Subcutaneous, Fezgo, and 5-Gar Hytrulo. Let me begin with DARS-Lex on slide 5. For the fourth quarter of 2024, Johnson & Johnson reported worldwide sales of Darzalex grew almost 24% on an operational basis to $3.1 billion, with full-year revenue reaching $11.7 billion. We are delighted that Darzalex growth and total revenue was driven by demand for Darzalex subcutaneous within hands, which represents 95% share of total Darzalex sales in the United States. and has a similar high share of sales outside the United States too. Darflex growth was driven by share gains of over three points across all lines of therapy and importantly by six points of growth in the longer treatment duration frontline setting. Darflex now represents J&J's largest product with strong continued growth projected for many years. This growth is a result of investments Johnson & Johnson has made in new studies to increase access to Darzalex subcutaneous width enhanced for more early stage and frontline patients, further expanding the commercial opportunity. As examples, in 2024, Darzalex subcutaneous width enhanced gained US and European regulatory approval for newly diagnosed patients who are eligible for autologous stem cell transplant in a combination regimen. A supplemental BLA has also been submitted for FDA approval for Darzalex subcutaneous within hands as part of a quadruplet regimen for newly diagnosed multiple myeloma patients for whom autologous stem cell transplant is deferred or they are ineligible. And we're also anticipating US and European approval for smoldering multiple myeloma. Each of these represents a compelling growth opportunity for Darzalex subcutaneous. These advancements support analyst projections of more than $17 billion in total revenue for Darzalex in 2028, with virtually all of this coming from Darzalex Subcutaneous within hands. And recall, we project earning royalties in Darzalex Subcutaneous until 2032. I'll now move to our second key driver, which is Roche's Fezgo, shown on slide six. Fezgo is the combined therapy of Progetta, Herceptin, and Enhance, which is given in a single, seven-minute subcutaneous injection for the treatment of breast cancer. We believe Fezgo is an underappreciated asset that has been garnering growing adoption globally. In the fourth quarter, Roche reported that Fezgo grew to 500 million Swiss francs, representing an increase of 72% year over year, and reached 1.7 billion Swiss francs, or approximately 2 billion US dollars for full year 2024. Fesco had strong uptake across all regions with conversion climbing to 46% in the 55 launch countries. Roche commented that they project conversion will continue to increase and will exceed 50% in 2025. With these strong results and expectations for continued growth, Analysts project FezGo will reach $3.4 billion in revenue in 2028, all of which is subcutaneous use within HANZ. And recall, we project earning mid-single-digit royalties on FezGo until 2030. Let me now transition to Ergenix's ViveGuard and ViveGuard Hotrula within HANZ on slide 7. Ergenix pre-announced preliminary results in January, with total ViveGuard, including ViveGuard Hotrula within HANZ, fourth quarter sales reaching $737 million for full year revenue of $2.2 billion. This remarkable launch success is driven predominantly by continued growth and adoption in generalized myasthenia gravis, where Vivegard Hetrula with Enhance was approved in 2023. Vivegard Hetrula with Enhance is playing a key role in Vivegard growth by expanding the number of physicians using Vivegard, adding those who do not wish to, or who cannot administer IV infusions. The ease of use of subcutaneous delivery is also enabling Vivegardt to move earlier in the treatment paradigm, expanding the addressable population. And note that we project earning royalties in Vivegardt-Hartullo through the early 2040. Further innovations that will expand the Vivegardt-Hartullo with enhanced opportunity is projected in the United States in April of 2025. with the potential FDA approval of a pre-filled syringe treatment option for Vivecart Hertrula with Enhance for all of the currently approved indications. Halotham co-created the pre-filled syringe with Ergenix, which may allow patient self-administration in just 20 seconds. Ergenix is also expecting the pre-filled syringe to be approved in Europe, Japan, and Canada in 2025. Helazam will receive the same royalty rate on the pre-filled syringe delivery as we receive on the vial, also through the early 2040s. Let me move now to the second indication, which is chronic inflammatory delamyelinating polyneuropathy, or CIDP, which is a subcutaneous 5-part hetrula with enhanced only indication. This is an exciting new growth driver that is really just beginning following the mid-2024 approval in the United States. and the end of 2024 approval in Japan. Argenix has seen strong interest in adoption, with more than 1,000 CIDP patients already receiving Vivegard-Hartullo. The patient testimonials shared by Argenix tell a powerful story of how Vivegard-Hartullo is helping CIDP patients regain their lives. Strong progress has been made in gaining that all-important coverage and access with now 90% of covered lives having access to five-part Hirtulo for CIDP under favorable or highly favorable policies. The brand is also benefiting from a halo effect of Ergenix being able to promote CIDP next to generalized myasthenia gravis to open up new prescribers. Already, 25% of prescribers for CIDP were physicians who had not previously been seen by Ergenix. In 2025, Argenix projects to continue on this powerful trajectory and also to expand the number of global approvals in CIDP. And not only are we just at the beginning in terms of these two indication launches, as you can see on slide eight, Kelozyme's journey with Argenix on their next wave of innovation for ViveGuard highlights the many exciting opportunities for many years to come with multiple active subcutaneous programs within hands in development including in thyroid eye disease and ocular myasthenia gravis. And as we look out even further, our journey with Ergenix was enhanced in 2024 with four new nominations within hands, which creates new opportunity and reinforces our leadership position as Ergenix's rapid, large volume, subcutaneous delivery technology of choice. I'll move now to slide nine, we had three additional significant approvals in 2024 for Olkervis Zenuvel, Ticentric Hybrisa, and Updivo QVantage. Based on benchmarks, we assume it will take six to nine months in the United States and more than 12 months in Europe to achieve robust access coverage and reimbursement. Given the recent approvals, we have projected minimal contribution from these products in our 2025 revenues, with contributions becoming more meaningful in 2026 and beyond. Let me begin with Roche's Ocrevus Zenuvel, which received EMA and FDA approval for the treatment of multiple sclerosis in 2024. Ocrevus Zenuvel with Enhance allows for an approximately 10-minute subcutaneous injection, which compares with multiple hour infusions that is typically required for the IV administration time. Roche has been very consistent with their comments that they believe the subcutaneous formulation within hands will expand the addressable market and grow the brand, adding prescribers and patients who did not have access to an infusion suite. In its most recent earnings call, Roche commented that the launch is progressing very much as planned, with more than 2,500 patients on Ocrevus Zenuvo globally. In the United States, they're seeing positive signals with 50% share of new Ocrevus subcutaneous patients being naive to Ocrevus. This is great news for two reasons. Firstly, it demonstrates market expansion and growth for Ocrevus, which is being driven by subcutaneous Lenovo. Secondly, the remaining 50% is coming from early conversion to subcutaneous Ocrevus from the very large patient pool who are on intravenous Ocrevus. Focusing on market expansion and growth Roche commented that they are seeing accounts that have not used Ocrevus IV in the past who are now prescribing subcutaneous Ocrevus. With the permanent J-code expected in April and projected to accelerate uptake, Roche further commented that they are confident that Ocrevus Xenuvo represents an incremental 2 billion Swiss francs or more than $2 billion opportunity for the brand. With full-year 2024 sales reaching 6.7 billion Swiss francs, or approximately 7.7 billion US dollars, this represents a very attractive growth opportunity for Halozyme. We project receiving mid-single-digit royalties on Ogrevis and Nuvo until 2030, and at a step-down rate until at least 2034. We're also excited that rosacea-decentralized Pagbresa was enhanced in FDA approval in September of 2024. The approval was for all of the IV indications and offers patients and providers with a more convenient treatment option within approximately seven minutes subcutaneous injection. Total to centric revenue represented 3.6 billion Swiss francs or approximately 4 billion US dollars in 2024. Roche plans to drive IV to subcu conversion and believes that subcutaneous formulation will be productive off the brand. and recall that we project receiving royalties onto Centra-Cabrisa until 2040. Moving now to Bristol-Myers Squibb's Opdivo QVantage, which was approved by the FDA in December of 2024 and represents our ninth approved product within hands. I will also note that the European submission is currently under review. Bristol-Myers Squibb commented recently that they were excited for the launch and what it could mean for patients, physicians, and the durability of their immuno-oncology business, with the new subcutaneous formulation helping to extend the reach and impact of their immuno-oncology franchise into the next decade. With their sales team out in the field relaying the benefits of Opdivo Q-Vantage, Bristol shared that the early feedback has been positive for the shorter injection time compared to IV nivolumab. Initial positive feedback they highlighted is in use in the adjuvant patients, and in patients who were treated in combination with the Eurovite, such as in first-line metastatic melanoma and renal cell carcinoma. Bristol expects that 30 to 40% of Opdiva IV could be converted to subcutaneous. Similar to any launch, reimbursement dynamics are going to take time, and BMS projects conversion will accelerate in the second half of 2025 after they transition to a permanent J-code in July. Opdivo Q-Vantage represents another very attractive conversion opportunity for Halosam. Opdivo, which is a brand name for IV Nivolumab, grew 7% excluding FX in the fourth quarter to $2.5 billion and reached $9.3 billion in annual sales in 2024. Now, I may also take this opportunity to comment on Amidvantamab Subcutaneous, which would represent our 10th approved partner product. Recall, amivantamab is included in our longer-term projections, as we consider it de-risked following strong Phase III data. Recently, Johnson & Johnson announced that they had received a positive opinion from the Committee for Medicinal Products of Human Use of the European Medicines Agency, recommending an extension of marketing authorization for the subcutaneous formulation of amivantamab with enhance, in combination with the lecithrinib, in the first-line treatment of adult patients with advanced non-small cell lung cancer. The European Commission approval is typically granted 67 days after the recommendation, which would support approval in the April 2025 timeframe. We're excited for the amivantamab sub-Q potential approval and what this could mean for patients. The subcutaneous formulation of the amivantamab offers an improved treatment experience for patients reducing administration time to approximately five minutes compared to anything from two to four hours for the IV. Importantly, there is also a five-fold reduction in infusion-related reactions. Moving now to the U.S. timeline, in December, Johnson & Johnson announced that they had received a complete response letter for amibantamab subcutaneous, which was related to observations as part of a standard pre-approval inspection at a manufacturing facility. J&J highlighted that the CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and that the FDA is not requesting any additional clinical studies. They are working closely with the FDA to bring subcutaneous amivantamab to patients as quickly as possible and are confident in a path to resolution. J&J has publicly commented that they believe amivantamab has a $5 billion revenue potential. Moving now to slide 10, we are confident in reaching our $1 billion royalty revenue projection in 2027. And indeed, we project we will exceed that. This confidence is driven by the expectation for the continued strong growth of our two lead assets, Darzalex and Fezgo, which represent a $20 billion total opportunity. And the layering of the four recent launches of Weibgart Haertsuelo, Cassandra Caipresa, Ocrevus Zenuvo, and Opdivo QVantage, plus the upcoming potential launch of adjuvantamab subcutaneous. Analysts project these five products represent an even greater opportunity in 2028 of $35 billion. I know that you agree that the near-term revenue growth to 2028 is very strong, and I often get the question, what's next? The good news is that the launched and launching products that we've just reviewed continue to provide very strong revenue post-2028, and we project several current pipeline products will contribute additional meaningful revenue post-2028 too. Let me walk you through some of the specifics which are shown on slide 11. Fesco is projected to continue to grow post-2028 and earn Halos M royalties at its full unchanged mid-single digit rate until 2030. Darth Lake's fast-growing subcutaneous is projected to remain our largest revenue driver until 2032, in Europe earning Halosam royalties at its full unchanged mid-single rate until March of 2029, and to continue to earn as royalties at half that rate until 2032. In the United States, we are confident that the pending new manufacturing IP will be issued which would also result in Halozyme earning royalties at the unchanged mid-single-digit rate until March of 2029 and continue to earn as royalties at half that rate until 2032. This is not currently reflected in our long-term guidance. Viagra Hytrulo is projected to earn Halozyme royalties for all of its indications sold either in the vial or through the pre-filled syringe at its full unchanged current mid-single-digit royalty rate until March of 2029, and then to continue to earn royalties until 2033 at a mid-single-digit rate even after a step down in the royalty rate. Royalties will continue until the 2040s after a further step down in rate. Moving to Okavis & Nuvo, this is projected to earn Halo's Emeraldies at the full mid-single digit rate until 2030, and at a step-down rate until at least 2034. And with Decentric Hybrisa projected to earn Halo's Emeraldies at its full mid-single digit rate until the 2040s, and Obdivo QVantage projected to earn Halo's Emeraldies until at least 2034, you can see why we project continued strong revenue from the current launch products beyond 2028. In addition, we're confident that the more advanced de-risk products from our pipeline will contribute revenue post-2028. For example, Optivo fixed-dose combination with Relatlamab and TAC881 are two additional de-risk revenue growth drivers post-2028. And we also anticipate additional products from our current Phase 1 pipeline, new nominations from existing partners, and from new deals will add additional royalty revenue streams. Now let me turn to the very important topic of new deals and new nominations. Our discussions continue with multiple companies regarding enhanced new nominations, enhanced new deals, our high volume auto-injector, and our small volume auto-injector. I'm going to start with some very exciting news on our small volume auto-injector. I'm pleased to announce that yesterday we signed a development agreement for our small volume auto-injector with one of our current partners for a commercial product. Moving to enhanced, Recall, we have two paths for growth. The first is gaining new nominations by current partners, and the second is through signing new deals. Beginning with the new nominations. In 2024, we made excellent progress with current partners, selecting five new targets for Enhance. In 2025, we will continue to work closely with partners to identify opportunities to select new nominations from their currently available open slots. Recall these additional new nominations, together with our current expanded pipeline, drive durability of revenue post-2029. And moving to the new enhanced deals, we are in active discussions with multiple companies. In 2025, our goal is to advance to collaboration and licensing agreements with at least one. And moving to our high-volume auto injector, our goal is to advance to a development agreement this year. I'm often asked why we've not yet signed a deal with a high-volume auto injector. What's the holdup? Our high-volume auto injector is a real innovation, which means some components are not available off the shelf. Some parts needed to be invented and designed. In 2024, we made progress with this, securing an exclusive supply for a high-volume primary container. This accomplishment has significantly de-risked the high-volume auto injector for partners and we're actively engaged in discussions with several parties. With that, let me now turn the call over to Nicole, who will discuss our financial results in more detail.

Thank you, Helen. Our strong fourth quarter results marked the end to another record year for the company, with the achievement of more than $1 billion in total revenue for the year. We grew total revenue by 22% and beat our guidance, which we increased twice during the year, and helped us grow non-GAAP EPS by 53%. With our bottom line growth outpacing the top line due to our high margin royalty revenue, we converted 74% of our adjusted EBITDA into free cash flow, representing $468 million. Free cash flow is expected to increase over the next few years to 80% of adjusted EBITDA in 2026. As we look ahead, we remain firmly on track to hit another milestone in 2027, with projections of more than $1 billion in royalty revenue with our achievements to date. Let me now turn to our detailed fourth quarter results on slide 12. Revenue grew 30% to $298 million compared to $230 million in the prior year period. Growth was primarily driven by royalty revenue, up 40% to $170 million. And higher revenues under collaborative agreements up 70% to $48 million, mainly due to more milestones achieved for enhanced sale-based milestones. The continued commercial success of subcutaneous Darzalex and Fezgo and early growth of Visgard Hytrulo for GMG, which launched in 2023, were the main drivers for our royalty revenue growth for the quarter. Suggested EBITDA increased 61% to $196 million in the fourth quarter, from $122 million in the prior year period, driven by high growth margins, 86%, coupled with modest operating expense growth of 5%. We also maintained a strong balance sheet with cash, cash equivalents, and marketable securities at $596 million on December 31st, 2024, compared to $336 million on December 31st, 2023. Our net debt position was $929 million with a net leverage ratio of 1.3 times. The increase in cash was primarily a result of cash generated from operations offset by $250 million deployed for share repurchases. Turning now to slide 13 for our detailed financial results for the full year 2024. I will briefly touch on some highlights here with more details available in our press release and 10-K filed with the SEC today. Total revenues grew 22% year-over-year to $1 billion and $15 million in 2024, off an already substantial revenue base in 2023 of $829 million. Robust growth was primarily driven by 27% growth in royalty revenue, totaling $571 million. as well as higher revenues under collaborative agreements and higher sales of proprietary products. Research and development expenses were $79 million compared to $76 million in 2023, primarily due to planned investments and enhance related to the development of our new high-yield RU-PH20 manufacturing process. Selling, general, and administrative expenses were $154 million compared to $149 million in 2023. primarily due to increased compensation expense and professional service fees, partially offset by planned reductions in commercial marketing expenses. Adjusted EBITDA increased 48% to $632 million from $426 million in 2023. GAAP diluted earnings per share was $3.43 and non-GAAP diluted earnings per share was $4.23. This is compared with GAAP diluted earnings per share of $2.10 and non-GAAP diluted earnings per share of $2.77 in 2023. In January, we raised our previous 2025 financial guidance for total revenue, our high margin royalty revenue, adjusted EBITDA, and non-GAAP EPS. As you can see on slide 14, we continue to expect total revenue of $1 billion and $150 million to $1 billion and $225 million. representing year-over-year growth of 13 to 21 percent. Royalty revenues of $725 to $750 million, representing year-over-year growth of 27 to 31 percent. As Helen touched on, we project Darzalex SubQ and Fezco will continue to grow substantially in 2025. And for the first time, Visgart HyTruLo with Enhance is expected to be the largest royalty dollar growth driver. When you couple our high margin royalty growth with flat operating expenses from our continued focus on operational efficiencies, we expect adjusted EBITDA of between $755 and $805 million, representing year-over-year growth of 19% to 27%, and non-GAAP diluted EPS of $4.95 to $5.35, representing year-over-year growth of 17% to 26%. Let me also take the opportunity to highlight how to think about the quarterly cadence for modeling. We expect first quarter royalty revenue to be less than the fourth quarter of 2024 by approximately 10% due to annual contractual rate resets with quarterly sequential growth thereafter. We project total revenues to decrease sequentially from the fourth quarter of 2024 to the first quarter of 2025 as no milestones are planned in the first quarter. and milestones are expected to be weighted in the second half of the year. And our product sales are also expected to be weighted in the second half of 2025. Let me now turn to slide 15 and highlight the remarkable growth we project over the next four years. From 2024 to 2028, we expect royalty revenue, adjusted EBITDA, and non-GAAP earnings per share will more than double, while total revenue comes close to doubling. increasing from our record greater than $1 billion we just achieved to $1.7 to $1.9 billion in 2028. Let me conclude on slide 16 and provide an update on our share repurchases. In December of 2024, we entered into a $250 million ASR under the $750 million approved program from February of 2024. This will complete by the end of the first quarter of 2025. Since the inception of the first program in 2019, we've returned $1.55 billion in share repurchases, an average of approximately $250 million a year. The average repurchase price from 2019 to 2023 was $31.46 per share. The impact of share repurchases has allowed us to reduce our diluted share count by 10%. As disciplined stewards of free cash flow, we will continue to evaluate share repurchase opportunities that offer a compelling return versus other capital deployment initiatives. Our strong EBITDA growth significantly de-rifts our capital position, as we have capacity to cover our debt obligations without overextending our resources, as evidenced by our low net leverage profile 1.3 times at year end, coupled with our impressive interest rate coverage of 30 times. We are in an excellent capital position to execute on both share repurchases and growth opportunities via M&A. With that, I'll now turn the call back over to Helen.

Thank you, Nicole. We're truly at a remarkable time in Halos M history, with nine products now approved and but one launched in multiple regions. Our high 2025 revenue and royalty growth is driven by just three of these products, Darzlik Subcutaneous, Fesco, and Vibe.Hertrulo. each of which bring durable revenues until at least 2030, and then the case of Weifgart-Hertullo into the 2040s. Our confidence and conviction in our multi-year guidance was further reinforced with the 2024 approvals of Ticenter-Cabriza, Ocrevus-Zanuvo, and Optivo-QVantage. Next up will be Amivantimab-SubQ, following the successful completion of the regulatory reviews. This adds four additional durable royalty streams, which will begin to contribute meaningfully in 2026 and continue to at least in the 2030s and in several cases to the 2040s. Our progress and performance would not have occurred without the dedication and hard work of the exceptional Halazan team and our partners. And I'd like to take just a moment to thank everybody who contributed. Operator, we are now ready to open the call for questions.

At this time, I would like to remind everyone in order to ask a question. Press star then the number one on your telephone keypad. We will pause for just a moment to compile the Q&A roster. The first question comes from Sean Laman from Morgan Stanley. Your line is open.

Hi, Helen, Nicole, and Tram. Hope you're all well and a nice set of results. Congratulations. I guess over the last... week and it's not lost on me that you've provided 28 guidance which not many companies look out that far but I guess a lot of the inbound that I get is you know what's beyond that and what sort of terminal value should you think about with Halazine so looking at your slide 11 and some of the issues that are going on there you know what's your confidence around some of the new uses for example we've got that you've detailed today and and maybe even some of the further Argenix-related programs that might come on board to mitigate any reduction in sort of earnings beyond that sort of 28 period, 20, 30 period.

Great. Thanks, Simon. Welcome to the coverage of Halazine. It's a great question, and in the prepared remarks, I covered that the way we think about post-2020 is really to look at the current 10 products that are approved or soon to be approved with amivantamab sub-Q and consider that they are going to continue to be contributing considerably at that time. And the slide that we show with the duration and royalty rate really does help bring that picture into perspective, showing that Every product will get royalties until 2030. Many of them will go to the mid-2030s and multiple ones will also go to the 2040s. Now, for 5GAR in particular, that is just considering GMG and CIDP. We are aware, and we've got six products that are public that are already sub-Q development plans or soon to start with their genics. But I do think we're going to have to wait for the results. On a mechanistic basis, I have high confidence there are IgG-driven diseases, and there's a lot of mechanistic rationale for why they'll work. But we don't forecast them in our near-term revenues just until we see that data. Now, on top of that, though, don't forget that we have a pipeline, which is in the deck as well. And if we look at some of the pipeline products, like Relatimab Obdivo and TAC881, those are highly de-risked as they already are approved as an IV and other formats. And so those will layer on top. Other products in that pipeline that are currently in phase one, new nominations that we expect from current partners and new deals all start to potentially contribute in that 28, 29 timeframe as well. And so on top of that strong base, we've got multiple opportunities to layer and add in it. And that's what makes us so excited about the durability and the strength of our royalty revenues for many years to come.

Thank you. I might save the rest of my questions for when we're due to talk later this evening, but thank you.

Thanks, John.

The next question comes from the line of Brendan Smith of TD Cohen. Please go ahead. Your line is open.

Great. Thanks for taking the questions. Congrats on another strong quarter. Maybe really quickly on BD, can you just tell us a bit more about, you know, what does the inclusion or integration of that small volume autoinjector realistically do for the existing or new partnerships, for that matter, when you're having those BD conversations, really just in terms of economics? And is that answer any different for the high volume autoinjector? And then just on the enhanced conversations, maybe what is left? in some of those late-stage discussions to really get partners over the finish line that gives you confidence in signing at least one new deal this year.

Yeah, thanks, Brandon. And obviously, we're excited to announce the small-volume auto-injector deal with a current partner who signed up for a commercial product. Now, that particular deal and any more information is confidential at this time, but what we can see is that when we add on a small-volume auto-injector deal, it starts with a development agreement. Those are structured in such a way that there's a certain fee for service, if you think about it like that, as we make progress in creating and developing the auto-injector, and then as that progress is made, we move into discussions on a commercial agreement. And for small volume injectors, the traditional structure would be that there would be a certain price per device, depending on volume, that includes a margin or a markup for the manufacturer in the case of Halazine. So it will be another revenue stream for Halazine that would be reflected in product sales. Now that's specific for the small volume out injector, but that does not need enhanced in it necessarily. When we think about the opportunity for the high-volume autoinjector, Enhance is the secret sauce for the high-volume autoinjector to work. And so high-volume auto-injector deals will be either associated with our current partners who already have Enhance or could be with new partners who are licensing Enhance and the high-volume auto-injector. Whichever way it goes, it is driving new royalty streams for us as it could be bringing new products into the clinic for current partners or brand new products into the clinic. And in addition to that, we would receive a certain fee, a product sales once again, on the sale of each and every device that we sell. So a nice layering on of both royalty edition and product sales in the case of the high-volume auto-injector. And, you know, the current agreement with the small-volume auto-injector is, I think, a nice illustration of patience. We have been in that conversation for a period of time. We've continued to work through just internal reviews and approvals, and it's exactly the same as what's happening on our discussions with high-volume auto-injectors and also in hands. And so we're in conversations with large pharma, with biotech. We're at different stages, still in technical review with some, but moved on to terms discussions with others. And we just have to patiently walk through each company's process to get to that decision. But based on the progress that we've continued to make, and I know from the outside it seems slow, but we are very pleased with the progress we're making. I am very confident we're going to sign additional enhanced deals and high-volume auto-injector deals. We just have to go through the processes.

Okay, great. Thanks very much.

Thanks, Bren. The next question comes from the line of Mohit Bansal from Wells Fargo. Please go ahead. Your line is open.

Great. Thank you very much for taking my questions, and congrats on all the progress. So a couple of questions from my side. Nicole, you mentioned that you're modeling negative 10% royalties for first quarter over fourth quarter. Hello. Can you help me understand what are the dynamics there? Because it has not happened in the past. And specifically, we've got a CIDP launch is going really well. That's the first question. And the second question is, how are you incorporating pre-field seedings transition and its uptake in the guidance because it seems to be going really well. Thank you.

Yeah, thanks for the question, Mohi. So when we look at royalties quarter over quarter, what we're seeing is we do have contracts that have an annual rate reset. So that will start over in January at a lower rate. And as we achieve volumes during the year, it gets back to the regular rate. The most material impact to us is from Darzelex. We have seen that last year, but as DARSlex continues to grow and contribute more, that impact is just a little bit more impactful to us. So that is the biggest driver, I would say, in the quarter-over-quarter impact that we see. With that product, I can share that the time to get to the full rate is very quick. It happens within the first few months of the year. So it is just a small portion of the quarter where we see that impact. And then also just highlight, too, we also see an impact related to our EpiPen royalties. That's just related to seasonality. That's also something we expect in the first quarter. But so those are really the drivers for just that sequential quarter-over-quarter growth. But also highlighting the very strong sequential growth expected. in 2025 for the full year, achieving full year growth from prior year of 27 to 31%, so very strong expectations for the full year.

And the second question, Nicole? Mohit, you cut out a little bit for me on the second question. Would you mind just repeating it?

Sure. Thank you for the first answer. So how are you incorporating refill syringe transition for WebGuard and uptake? in the guidance because it seems to be going really, really well here.

Yeah, based on public comments that Argenix has made, they are expecting the pre-filled syringe approval in April of this year. I think we've talked in the past that we meet with our partners towards the end of the year and they give us their projections arranged for performance in 2025. And so we understand that Argenix will have contemplated that in the information and the range they gave us. While we can't get into specifics, our guidance already reflects the potential increase that pre-filled syringe could bring. And I think what people are, I think, very excited about, it can bring the potential for a 20-second at-home injection by patient and could be adding more patients in both GMG and CIDP in 2025. But we believe it's already reflected in the ranges we received. Great. Thank you, sir. Thank you. Thank you, Helen and Nicole. Bye.

The next question comes from the line of Jessica Fai from J.P. Morgan. Your line is open.

Hey, guys. Good evening. Thanks for taking my questions. With the small volume auto injector deal you signed with an existing partner for an existing commercial product, When would you anticipate that we might discover which partner that was and on which product? And just for the avoidance of doubt, this was for a product that's not a current enhanced product. Is that correct? And then second, just a quick one. Can you just remind us how you define mid-single digits when you talk about the royalties you receive? Thank you.

All right, Seth. I'll take the first one. Okay. Obviously, we're excited that we just signed the small volume auto-injector. Based on the partner's desire to keep this confidential, we actually have not established with them yet when they would want to talk about it. And I really can't say any more about it at this period of time. But we obviously are interested in communicating as soon as possible and we'll provide updates as soon as we learn more with regard to that. Nicole, would you talk about the range for mid-single digits?

Yes. When we talk about mid-single digit, we're really plus or minus 5%. And so in our mind, we use 3% to 7% to represent mid-single digits.

Great. Thank you.

The next question comes from the line of Michael Dufiore from Evercore ISI. Please go ahead. Your line is open.

Hey guys, thanks for taking my question and congrats on the progress this year. In light of the fact that VivGuard's overall brand sales in 4Q had a noticeable inflection, and your comments on how VivGuard Hytrula will be the biggest growth contributor in 2025, just want to get your take on whether 2025 may be the year that the sub-Q formulation exceeds the Ivy sales to the extent that you can, if you could add any color on that. I know back in November, our genetics mentioned that the Ivy still comprises the bulk of sales, but wondering if you see any, any change in the mixed over the course of 2025.

Yeah, thanks for that question, Mike. I mean, obviously, the comments that Argenix has made, we're delighted with the success and uptake that we're seeing with Vivegard, both in CIDP and GMG. In terms of when Vivegard subcute could take over IV, you know, as Argenix has not provided any perspective on that, it wouldn't be appropriate for us to comment on that. But certainly, you know, we are hearing very much that because it's allowing more physicians to start prescribing, because it's moving therapy earlier in the treatment, and because the CIDP launch is going so well already with already a thousand patients on treatment, we are very excited to when that event actually happens. But I can't communicate when that's anticipated.

Got it. I have one quick follow-up, too. Thank you for that, Helen. And maybe I'm reading too much into this, but on slide 23, the three undisclosed products and indications at the bottom of the table on slide 23, could this mean that three new deals are expected to be announced this year, or does that reflect current partnerships? Thank you.

Yeah, all of those three are coming from current partners. As an example, recall that we had five new nominations from current partners last year, but we also have the opportunity for current partners also to nominate any time with their open slots. And so all of them are current partners, and any new deals moving forward would be over and above that.

Got it. Thanks so much.

The next question comes from Jason Butler from Citizens JMP. Your line is open.

Hi, thanks for taking the questions. Helen, you mentioned for the large volume auto injectors, both the need and the work you did in 2024 to invent and build new device components. I guess to what extent is that work potentially specific to a product or small number of products versus broadly leverageable across multiple partnering conversations. And then second question for me is, I guess for Nicole, just any call you can give on what's remaining on the $250 million accelerated buyback. Thanks.

With the high-volume auto-injector, we have been engaged in multiple conversations with various companies, and it has given us a perspective as to what is going to be an attractive primary container, and so that's exactly what we proceeded with. We believe that what we have moved with with that particular element will be suitable for multiple partners. Now, it might not be suitable for every partner. Someone may want something custom-developed, but we decided to make the investment so that we are ready and prepared for partners who are most likely going to want that size of primary container based on the conversations that we have had. Nicole, on the ASR.

Yeah, thanks, Jason. On the ASR, so I can't share specifically how much our bank has executed through the $250 million. They did start executing on our behalf in December. That will run for a number of months. But the benefit, recall the benefit of this is that we did get approximately an estimate of 80% of the shares delivered to us in December. So those who are retired at the start of the program, at the final settlement date, we will then calculate with our bank what the final average purchase price was and the final delivery of the shares. So have already received a good majority of the benefit from a retiring the shares perspective. And then in the coming months, we will know the final averaging date and have completed the $250 million. Great.

Thank you.

The next question comes from Michelle Kapoor from HCU RainRide. Your line is open.

Good afternoon. This is Dan on for Mitch. Congratulations on the earning fee. Thanks for taking our question. So when you think about business development, are you more focused on larger deals or groups of smaller deals? And are there any contract obligations prohibiting partnering agreements with PD1 BGS by specific programs? And if not, what's the interest in partnering with one? Thank you.

All right. Thanks for the question, Dan. With regard to BD, I can say that we are talking to multiple companies across large and small deals. As you hear, small deals, which we could define as companies who are perhaps earlier stage can turn out to be incredibly attractive future opportunities. And I'll use the example of Argenix and Fiveguard. They were barely known when we kind of started working with them. And so we look at each individual opportunity, assess that opportunity and proceed based on that. But we're talking about IV to sub-Q conversion. We're talking about sub-Q extended dose. We're talking about exclusive and non-exclusive arrangements. There's really a very nice array of opportunities that we are progressing towards consummation of deals in 2025. With regard to the specific question on the PD-1 bispecific, based on the exclusive terms of the agreement we have with Bristol, we would not be able to partner on a PD-1 bispecific.

Okay, thank you very much.

And that's the end of our Q&A session. Ladies and gentlemen, that concludes today's call. Thank you all for joining, and you may now disconnect.