Halozyme Therapeutics, Inc.

Question, press star one again. Please note, this event is being recorded. I'll now turn the call over to Tram Bui, Holozymes Vice President of Investor Relations and Corporate Communications. Please go ahead.

Thank you, operator. Good afternoon, and welcome to our third quarter 2024 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, Hale-Assam's President and Chief Executive Officer, who will provide an update on 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 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 will now turn the call over to Dr. Helen Tworley.

Thank you, Drummond. Good afternoon, everyone. Let me start in slide three. I am very pleased to report we delivered strong third quarter financial results with a 34% increase in total revenues to reach an all-time high of $290 million in the quarter. This was largely driven by royalty revenue, which increased 36% to another record amount of $155 million. This performance reflects the continued expansion and broadening of adoption of our enhanced drug delivery technology with continued strong growth of Darzalex subcutaneous Fezgo, and FiveGuard High Trullo. Based on our strong year-to-date performance, we are raising our total revenue, our royalty revenue, adjusted EBITDA, and non-GAAP earnings per share guidance ranges for the full year. Notably, this year we now expect to deliver high double-digit revenue growth of 17% to 23%, and an impressive adjusted EBITDA growth of 40% to 47%. Nicole will go into more detail on this in a moment. Operationally, it was also another strong quarter. Two current partners nominated new targets for enhanced under expanded licensing agreements, adding new revenue in terms of milestones and reinforcing the value of our leading drug delivery technology. We've also continued our focus on securing new enhanced deals and also new agreements for our small and our high volume auto injectors with discussions continuing and advancing. Roche, one of our most tenured partners, gained two significant regulatory approvals, with the FDA approval for concentric subcutaneous with enhanced and for ocrebit subcutaneous with enhanced. And adding to this, multiple partners continue to expand their geographic approvals and advance their clinical development programs. These achievements are key drivers of our current and future growth trajectory. They reinforce our leading position in rapid large volume subcutaneous drug delivery and illustrate the well-proven success and predictability of our platform technology. I'll now move to slide four, and we'll provide some more details on these recent accomplishments. In September, we were delighted to announce two highly anticipated partner approvals, which reinforce Enhance's track record of 100% phase three to regulatory approval success. The U.S. approval of ROCHA's two centers Hybrisa with Enhance represents the availability of the first and only subcutaneous anti-PD-L1 cancer immunotherapy. Approval was granted for all of the adult IV-tocentric indications, with treatment delivered as an approximately seven-minute subcutaneous injection. Roche also received U.S. approval of Ocrevus Zinubil with Enhance, which is our eighth partnered product approval, and further extended Enhance's reach into neurology. With Ocrevus Zinubil, Multiple sclerosis patients can now receive their treatment as a 10-minute subcutaneous injection given twice a year compared to a multi-hour treatment for the intravenous also given twice a year. This dramatic simplification of treatment also creates the opportunity for patients to receive their treatment outside an IV infusion facility potentially closer to their home. These two recent approvals add to the significant growth opportunity we have right in front of us building on and adding to the recent European launches of Ticentric and Ocrevus subcutaneous with Enhance. Let me move now to the partner agreement expansion. Enhance is the gold standard for rapid subcutaneous large volume drug delivery. This has been established over the last 10 years as a result of the strong safety track record and the unmatched history of global regulatory approvals and commercial success. This success is supporting productive conversations with existing partners who have experienced firsthand the success they can achieve with Enhance. We're pleased that this has resulted in five new target nominations in the quarter. In early October, we announced that Ergenix expanded their agreement for the exclusive license to Enhance by nominating four additional targets. Based on this expansion, Ergenix has now exclusively licensed Enhance for a total of six targets including Vivecar Hytrulo. As part of the agreement, Argenix will make a $30 million payment to Halosim for the four new targets. There are potential future milestone payments related to development progress, regulatory approvals, and sales attainment of up to $85 million per new target. We are very excited to expand our relationship with Argenix, who is an innovative leader in immunology. As their partner of choice for rapid large volume subcutaneous drug delivery, we appreciate their patient centric mission that is so closely aligned with our own commitment to approving the lives of patients through our innovative drug delivery technologies. In the quarter, we've also expanded their existing global collaboration and licensing agreement, which gives them exclusive access to our enhanced drug delivery technology for one additional undisclosed target. Now with that overview, I'll move now to discuss the progress of our milestone and royalty generating subcutaneous commercial products, starting with Johnson & Johnson's Darzalex on slide five. In the quarter, worldwide sales for Darzalex increased almost 23% on an operational basis to represent the first asset in the J&J portfolio to reach $3 billion in a single quarter. Darzalex growth was primarily driven by share gains of four points across all lines of therapy, with 7.7 points of growth in frontline setting, as well as continued market growth. With conversion to Darzalex FastPro within hands exceeding 90% share of sales in the United States, and with very high conversion rates outside the United States, Subcutaneous Darzalex is the driver of this remarkable continued strong Darzalex growth. Further expanding Darzalex Subcutaneous Indications and Opportunity, During the quarter, J&J announced additional new approvals and regulatory submissions. U.S. and European approval were recently received for an additional indication for Darzalex with enhance in newly diagnosed multiple myeloma patients who are eligible for autologous stem cell transplant in combination with bortezomib, lenalidomide, and dexamethasone. The company also announced the submission of a supplemental BLA to the Food and Drug Administration for approval of a new indication of Darzalex Faspro as part of a quadruplet regimen for the treatment of adult patients with newly diagnosed multiple myeloma for whom autologous stem cell transplant is deferred or who are ineligible. With that, I'll now turn to Roche's Fezgo, which is shown on slide six. Fezgo, which is a fixed combination of Progetta and Herceptin within HANS, continues to demonstrate excellent growth momentum. Sales increased 58% to 1.2 billion Swiss francs for the first nine months of 2024. Uptake remained strong as additional countries launched with 55 countries now launched. Conversion of Progetta has also increased to 43% in those countries. Fesco is in a strong trajectory and is well positioned to reach and exceed 50% conversion by 2026. Also shown in the slide is updated analyst revenue consensus for Fezgo. With the strong growth and momentum I've just discussed, Fezgo is now projected to become a $3.5 billion brand in 2028. As all of this $3.5 billion in sales represents subcutaneous sales on which Halazime is paid in mid-single-digit royalty, Fezgo represents another strong growth opportunity for Halazime. Moving now to additional highlights on Roche's two most recent launch products, which are shown on slide seven. I'll start with Ticentric Hybrisa. Following European approval in January of this year, we were very pleased that similarly to Europe, the U.S. approval was granted for all of the adult IV indications. Ticentric Hybrisa, co-formulated with Enhance, allows for an approximately seven-minute subcutaneous injection compared to 30 to 60 minutes for the IV infusion. Dementializing the opportunity, Roche reported Tocentric revenue of 2.7 billion Swiss francs for the first nine months of 2024. Analysts predict that Tent-Centric will achieve $5 billion in 2028. Roche has stated that they expect the majority of the sales of Subcutaneous Tocentric will come from conversion of the intravenous portion. Let me move now to Roche's Okavis Renewal. I'm particularly excited for the U.S. launch following the Food and Drug Administration approval in September. This approval follows closely on the European approval, which occurred in June of this year. Ocrevus' maneuver with Enhance expands our reach in neurology and offers multiple sclerosis patients a treatment administration time of just 10 minutes via subcutaneous injection with Enhance, which compares to multiple hours required for the IV infusion. The subcutaneous formulation offers patients all of the benefits that they expect from Ocrevus in terms of the strong clinical profile and every six months dosing, while easing the administration burden of receiving treatment. Ocrevus revenue increased 9% to 5 billion Swiss francs for the first nine months of the year, driven by all regions. Roche has commented on the recent quarterly call that they are confident the subcutaneous formulation within hands will expand Ocrevus' footprint in the multiple sclerosis market and represent an incremental $2 billion sales opportunity. The availability of subcutaneous also makes this possible by opening up the treatment opportunity at smaller community hospitals as an example, making it easier for patients to travel to receive treatment. WASH also sees an opportunity for patients to convert from IV Ocrevus II to the subcutaneous version. Roche has commented that they are seeing promising first signals regarding the uptake in the U.S., which is sporting market expansion. About 80% of the new starts on Ocrevus Renewal are coming from patients who are new to brand and who are not switches from Ocrevus IV. Let me move now to Ergenics and Vivecart-Hertullo, which is shown on slide eight. Argenix's ViveGuard continues to experience strong momentum in its first indication of generalized myasthenia gravis. Argenix recently commented that they expect subcutaneous ViveGuard will grow in importance with patients, physicians, and payers. We're pleased that subcutaneous ViveGuard with Enhance is already expanding the market by bringing in new patients and providers to ViveGuard, with patients switching from oral medications to subcutaneous, including patients who don't have easy access to an IV infusion center. Moving now to chronic inflammatory demyelinating polyneuropathy, the second indication. While the launch is recent, Argenix has commented that with the unmet medical need, they are happy to see high awareness for the subcutaneous option amongst patients and physicians. Argenix expects to create fast and broad access for CIDP patients similar to what they accomplished in their launch in myasthenia gravis. We're also looking forward to the approval of a pre-filled syringe for Vivegard-Hertrula with Enhance, which will introduce a more convenient administration option for patients with GMG and also CIDP. The pre-filled syringe filing has a BEDUFA action date of April 10th, 2025. Energenics has also continued to expand its presence in additional regions, Most recently, its BLA for F-criticimod subcutaneous within hands for GMG was approved in China, increasing number of approvals to more than 25 countries globally. Given the strong launch of Viveguard, multiple analysts currently project total sales to reach almost $5 billion in 2028 for just the first two approved indications. We believe there is considerable opportunity to increase the total addressable market for Vivecart as Ergenix continues to advance its pipeline and the product strategy by expanding to additional indications over time. We're pleased to be supporting two registrational studies evaluating Vivecart Hytrulo within hands administered by pre-filled syringe in thyroid eye disease, an indication where there is still a high unmet need. In addition, in October, Argenix initiated a phase three study evaluating Vivegard-Hertullo with Enhance for ocular myasthenia gravis. And also recently, Argenix initiated a phase two trial in kidney transplant recipients with antibody-mediated rejection. Now, beyond Vivegard-Hertullo, Argenix has a robust pipeline of multi-indication assets, including mPasipirabart or ARGX117. As an innovator committed to improving patients' lives Argenix was at the forefront of recognizing the benefit of subcutaneous delivery. The early success of Vivecart and Trullo is a strong proof point in the value proposition of enhanced enabled subcutaneous delivery. And we are very pleased to have expanded our agreement with Argenix from two to six nominations and to be their partner of choice for rapid large volume subcutaneous drug delivery. Let me now move to slide nine for an update additional products that are awaiting regulatory approval and launch. I'll begin with Bristol-Myers Squibb Nivolumab Subcutaneous. Bristol received regulatory filing acceptance in the U.S. last quarter for Nivolumab Subcutaneous with Enhance with a BDUFA action date of December 29th of this year. The European submission is also under review. Once approved, this would represent our ninth approved product with Enhance. Nivolumab subcutaneous within hand has the potential to benefit both patients and physicians with a less than five-minute treatment administration time. Obdivo, which is the brand name for IV nivolumab, is currently $9 billion in annual sales. Bristol has stated that it projects the granted subcutaneous indications will represent 75% of these total sales. They also stated they expect to convert between 30% to 40% of the IV nivolumab to subcutaneous nivolumab. Johnson & Johnson's amifantamab subcutaneous width enhancer is also pending regulatory approval and is currently under priority review with the FDA. Approval would represent our 10th launched partner product. Earlier this year, exciting data from the PALOMA3 trial for amivantamab subcutaneous was presented at ASCO. The presenters highlighted a five-fold reduction in infusion-related reactions as compared to the intravenous, a five-fold reduction in treatment time, and also they presented the results of an exploratory analysis, which revealed an improved overall survival rate for the subcutaneous treatment arm. During their last earnings call, J&J highlighted that they believe Riborvan, which is the brand name for amivantamab IV, is one of the three largest underappreciated assets in their portfolio in terms of revenue projections versus what analysts are currently estimating for the back half of this decade. What is clearly exciting is that the five recently launched and soon to be launched products represent almost $35 billion in total brand opportunity. according to analysts and company estimates. This represents an even larger opportunity than the DARS-like subcutaneous and FESCO opportunity, where analyst projections are $20 billion in 2028. As Halosam receives on average amid single digital royalty and subcutaneous sales, you can clearly see how these products will add significant revenue over the next years and result in our projecting to achieve greater than $1 billion in royalty revenue in 2027. Let me now move to slide 10, where I'll mention a few highlights and some of our future potential launch products. Bristol-Myers has continued to advance their phase three study for nivolumab plus rilatilumab with enhance in first line non-small cell lung cancer. The IV combination is already approved and has a brand name of Duolag. Takeda also continues to advance their phase three study with TAG881. their 20% IDG product candidate, which is progressing in a phase three trial for the treatment of primary immunodeficiency. With all of this continued strong growth of our approved product, the exciting launches that are just beginning, and the regulatory and clinical advancements, we are well positioned to continue to deliver double digit top and bottom line growth in the coming years. Let me now transition to slide 11 and I'll make some comments on intellectual property. Our extensive patent estate supports the durability of our revenue streams and we continue to take actions to extend and protect our IP portfolio. In June, we were granted a new patent for Enhanced by the European Patent Office, which extended patent coverage of our technology in that region to March the 6th of 2029. This resulted in an update to our guidance we currently have a similar pending reissue patent in the United States that we're confident will be granted. We look forward to providing an updated financial outlook if that reissue patent is granted with similar claims. And as a pioneer in developing human hyaluronidases for subcutaneous administration of medicines, we were very excited to introduce our MDase patent portfolio that broadly covers modified human hyaluronidases. Halazan created the first soluble human hyaluronidase that was active at neutral pH, which we call Enhance. Notably, we did not stop there. We continued to innovate and experiment. And over many years and thousands and thousands of experiments, we created a large and comprehensive library of modifications, and we characterized those modifications. This groundbreaking work and other research projects created the technology protected by the MDase patents which are distinct from the patents that cover the truncated human hyaluronidase that we license as our enhanced technology. Now, why are we discussing the MDase portfolio now? There really are two key reasons. Firstly, we've recently been issued multiple new MDase patents, bringing the total granted and pending patents to nearly 100. And we wanted to distinguish the MDase patents from enhanced to avoid any confusion. Secondly, as an intellectual property licensor, we always are looking for new opportunities to commercialize our discoveries and to enable others to bring forward new solutions and therapies that help patients. The enhanced technology is the de-risked gold standard for conversion of IV therapies to subcutaneous administration. However, we do recognize that not every drug and biologic supplier might be able to or select to use enhanced. but they do wish to utilize or are utilizing Halazine's pioneering, modified hyaluronidase intellectual property. It's in those cases that the MDase patents are now available for license and would open up new opportunities for Halazine that do not impact our enhanced business. I'll now hand the call over to Nicole, who will discuss our financial results in more detail.

Thank you, Helen. I'll begin with an overview of our third quarter performance and then review the increased guidance ranges for 2024 that are resulting from our strong progress. Our robust financial results for the third quarter exceeded expectations due to higher revenues from royalties and collaboration revenues in the quarter. The result is an impressive 34% increase in total revenue from prior year. With adjusted EBITDA and non-GAAP earnings per share growth outpacing our top line growth at 60% and 69% respectively, a clear demonstration of the significant leverage we have with our high margin business model. Let me now turn to slide 12 for our detailed financial results for the third quarter. Revenue grew 34% to $290.1 million compared to $216 million in the prior year period. Royalty revenues for the quarter were $155.1 million, an increase of 36% compared to $114.4 million in the prior year period. The continued growth of subcutaneous Darzalex, Fezgo, and VidGuard Hytrulo were the main drivers of our royalty revenue growth in the quarter. The contribution from all three products exceeded our expectations for the quarter, resulting in an increase in guidance for the full year. Collaboration revenues for the quarter were $48.4 million compared to $15 million in the prior year period. The performance exceeded our expectations for the quarter due to the meaningful expansion of our Argenix collaboration. Research and development expenses were $18.5 million compared to $17.3 million in the prior year period. The increase was primarily due to increased compensation expense. Selling, general, and administrative expenses were $41.2 million in the quarter, up from $35.3 million in the prior year period, primarily due to increased compensation expense and consulting and professional service fees. Adjusted EBITDA increased 60% to $183.6 million from $114.9 million last year. GAAP diluted earnings per share was $1.05 and non-GAAP diluted earnings per share was $1.27. This is compared with GAAP diluted earnings per share of 61 cents and non-GAAP diluted earnings per share of 75 cents in the third quarter of 2023. We maintained a strong balance sheet with cash, cash equivalents, and marketable securities at $666.3 million on September 30, 2024. compared to $529 million on June 30, 2024. The increase was primarily a result of cash generated from operations. Our net leverage ratio was 1.4 times at the end of the quarter, and we still expect to reduce our net leverage ratio as EBITDA continues to grow. As a result of our strong year-to-date performance and expectations for continued momentum in the fourth quarter, We are raising our guidance ranges for the full year as shown on slide 13. We now expect total revenue of $970 million to $1 billion and $20 million, an increase year over year from $829 million, which represents an increase of 17% to 23% over 2023. This includes our expectation that collaboration revenue will contribute $130 to $150 million, and product sales will contribute $290 to $305 million for the full year. We expect royalty revenues of $550 to $565 million, an increase year-over-year from $448 million, which represents 23 to 26% growth over 2023. The increase in our expectation for the year is due to the strong performance of subcutaneous Darzlex, Fezgo, and Viscard Hytrulo. We expect adjusted EBITDA of $595 to $625 million, an increase from $426 million in 2023, a 40 to 47% year-over-year increase. And we expect non-GAAP diluted EPS of $4 to $4.20, an increase year-over-year from $2.77, which is a 44% to 52% increase over 2023. With that, I'll now turn the call back over to Helen.

Thank you, Nicole. Our strong year-to-date performance is a reflection of the execution of our strategy and the power of our durable, high-growth business model. This resulted in a meaningful raise in our expectations and our financial guidance for the year, resulting in impressive year-over-year growth and setting us up for a strong start to 2025. We have multiple drivers that will support our continued growth, including an exciting series of launches that are just beginning or are soon to commence. I'd like to close by recognizing and thanking the Halazan team and all of our collaborators whose continued dedication and performance has made this such a remarkable quarter and year. Operator, we're now ready to open the call for questions.

Thank you. The floor is now open for questions. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset to ensure that your phone is not on mute when asking your question. Your first question comes from the line of Vikram Purehit of Morgan Stanley. Your line is open.

Hi, everyone. Thanks for taking our question. This is Morgan on for Vikram. So one from us on the OkraVis and Dicentric recent launches. Although it's early, what's your current view on sub-Q conversion for these products and how that could ramp in the coming quarters and what that may look like long-term on a steady-state basis? Thank you.

Yes, thanks, Morgan. We'll start with Ocrevus, and I think it's important to note there, and Roche reiterated this on their quarterly call just a week or so ago, their goal with the sub-Q is not to immediately convert the IV to sub-Q, so it's not a conversion strategy. It's very much a market growth strategy, where they see the availability of subcutaneous as allowing more treatment centers and more throughput of patients at infusion suites, community hospitals, because of the much shorter treatment time with subcutaneous and the easier approach to SubQ, which doesn't require as much infrastructure. Indeed, they commented that they see the availability of SubQ will expand the Ocrevus market by about $2 billion. So initially for Ocrevus, FieldForce will be very much focused on getting new prescribers and helping those new prescribers set up and start using Ocrevus. If I move to Ticentric, obviously Ticentric continues to perform well in its key tumor indications as an IV given over 30 to 60 minutes. Within that, there are patients who are receiving Ticentric as an example as monotherapy or for whom they're on a complex regimen where they want to have a shortened regimen. And in that instance, there's going to very much be a field focus to convert those patients from the IV to the sub-Q because of the much simpler regimen. And so we are going to see conversion focus with Ticentric. market growth for Okravis. Roche has not given out any numbers as to where they see the conversion. Our approach has generally been to look at the success they had with Herceptin sub-Q in Europe, which got to 60% share of volume, and then to have a range around that depending on is the company driving for that sub-Q conversion. So particularly for Tocentric, I'd think about it in those terms.

Thank you.

Your next question comes from the line of Brendan Smith of TD Cowen. Your line is open.

All right. Great. Thanks so much for taking the questions. Congrats on the solid quarter. I wanted to first actually kind of piggyback on that last question about Okra versus SubQ. You know, you call up the language from Roche about that $2 billion. Just to kind of better understand that or maybe contextualize it a bit, I mean, if consensus for peak sales is around 9, 10 billion there, that might suggest only about 20% share of the sub-Q. Is that maybe the right way to think about that? Or is this 2 billion really kind of new to brand patients that would be in addition to IV to sub-Q switchers? And then maybe just really quickly on the Wave 4 pipeline, are you able to give us any sense of at what point we might learn about the additional Roche and Chugai drugs, just whether target indication, it's like after phase two data or something like that, just trying to understand when we might start focusing more on that wave. Thanks very much.

Yeah, thanks, Brendan, and thanks for asking that question because I do think the way Roche has been talking about it has led people to be a little bit confused. So, there's going to be a market expansion which is on top of the IV opportunity. And so if it's at 9 billion, my view is this is going to take the total growth in the next several years to be 11 billion. So you do add on the additional 2 billion. But the original IV sales of the 9 billion will, we strongly believe, be converted. When you think about what the difference is going to be for a patient, Instead of up to three and a half hours to five and a half hours in an infusion suite, it's going to be 30 minutes in an infusion suite. And so there is also going to be that conversion of the IV to sub-Q. I think what you're going to see is it's going to be phased. The initial launch focus is on expanding the market. And over time, we're going to see the conversion begin and grow as well. But when we're hearing from Roche, they very much want to highlight this is not just a cannibalization opportunity. So don't think about the pie staying the same size it is today. The pie is going to get bigger and then also going to be the opportunity to convert that bigger pie to be more sub-Q sales. Just on that, they also made a comment on their call that they are seeing already the strategy at work in the U.S., obviously very recent launch in the U.S., but they're seeing that 80% of new starts on Okra Vista Nuvo are new to brand. So very much supporting that approach they have where they don't want to cannibalize their IV sales. They want to further expand their opportunity while they also will be able to over time get that sub-Q conversion to With regard to the specific Roche and Shugai products that are listed on our Wave 4 portfolio, unfortunately, until the partners want to discuss exactly what those indications are and announce their plans for them, we are unable to discuss it any further. So, can't give any updates at this time.

All right. Thank you very much. Appreciate it.

Your next question comes from the line of Mike DeFior of Evercore ISI. Your line is open.

Hi, guys. Thanks so much for taking the question, and congrats on the solid quarter. Two for me. First question is, any status update regarding your expectations for new collaboration deals to be made before the end of the year? And I have a follow-up.

All right. Thanks, Mike, for that. You saw probably that we have provided our guidance for the year on the collaboration, expecting $130 to $150 million. And we're very pleased with the progress we've made here. Obviously, strong contributions from the expanding the agreement with our GenX in particular in the quarter. I will say we're not letting our feet off the gas pedal, and we're remaining very focused on gaining new deals and additional new nominations as we close out 2024. But if you do take a look at our guidance, you can see where the range we're predicting based on what we have line of sight on today is in that $130 to $150 million range. Got it, got it.

And my follow-up question is regarding MDACE. Considering that the MDACE licensees are non-exclusive and won't involve Halozyme support services or API supply, as you previously noted, how will licensees manage development and regulatory challenges that are typically supported in traditional enhanced partnerships, and how may this affect MDACE's adoption and commercial success compared to enhanced partnerships?

Yeah, I will be clear and say we do expect that the vast majority of companies are going to want to and be able to work with Enhance. And so as we think about where we're going to be focusing and our growth is going to come from, it's going to be new partners and expanded partnerships related to Enhance. But as we pointed out, there may be instances where somebody is unable to or for some reason doesn't want to work with Enhance, but they are utilizing our modified hyaluronidase IPs. We are, in that instance, only going to grant them a license, as you point out. Now, we obviously don't have a modified hyaluronidase VP product substance, so that company will have to... do what we did for the last 10 years, which is identify how to develop a product, engage with the regulatory authorities, start developing that safety database we have to demonstrate the product is safe and effective. But we would not propose to help them because we are going to be continuing to support our current enhanced partners. but we will license the IP because they're going to be using their M-Days, the modified hyaluronidase, for the same purpose as Enhance, and obviously that's where the value of our IP is being realized.

Got it. Very helpful. Thanks so much.

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

Hi. Thanks for taking the question. Just one on Vivgard Hydrullo and the pre-filled syringe. Can you maybe just speak to the progress there with FDA and how your work with other collaborators or other products has inputted into this regulatory process? Thanks.

Yeah, thanks, Jason. If you listened to the call today, as we did, our gen exam provided the update and just summarized that they are expecting a PDUFA action date that is going to be in April. We don't have any other information that we can share with regard to that, but we are excited that they are obviously progressing with that in studies that are ongoing, both in thyroid eye disease and other indications now. Again, this really has been work that we have done, obviously, in providing the Enhance for that prefilled syringe work, but I will say Ergenix has been lead with regard to the actual mechanical work in that. We obviously continue to advise on the formulation of Enhance, and so we don't have any information other than that I can share, Jason.

Okay, great. Thanks for taking the question.

Your next question comes from the line of Corrine Johnson of Goldman Sachs. Your line is open.

Hi. Good afternoon, everybody. Mimi, could you expand a little bit on the primary drivers of that increase in royalty revenues? You mentioned the products that are driving it, but I'm curious if it was additional indications within DARSlex, et cetera, better than expected conversion on the key products or anything else that you could kind of point to. And then could you also talk a little bit about where you stand on potential auto-injector partnership deals? We haven't really seen anything yet. I'm just curious if there's any additional work you're doing to kind of prove out that technology thing.

Yeah, small bits of color we can bring based on what our partners have stated publicly. I think we can say for Darzalex, They reported a very strong quarter, obviously with great sequential and year-over-year growth. And what they are talking about is just continued expansion of four points of share gains across all indications and 7.7 points of share gain in the front line. And recall the front line is actually the largest population of multiple myeloma patients, and those are the patients who stay on therapy the longest. And so I really think the growth that we've seen over the last several years has been fully enabled by the availability of sub-Q to expand as we're getting new indications into that frontline setting. So that's really, I think, where it's very exciting. If we turn to Vivecart Hytrulo, based on the call this morning, what we heard was that the majority of the revenue is obviously still coming from the GMG indication where they're continuing to see broadening adoption of Vivecart and also Vivecart Hytrulo with Vivecart Hytruli really helping move into that early line of therapy. So that is on a strong trajectory. What has begun to impact with 5-car Hytrulo is the CIDP indication. Specific comments were made about the fact that 300 patients on therapy, many of whom who came on in September, really occurring after the peer policies were in place. And so that actually bodes very well for continued strong growth as those patients that will be reflected as a full quarter in the next quarter. And so those are some of the key drivers. I'd say for Fesco, it's just continuing on that very nice trajectory that we've seen as there's just growing recognition of what this means for patients. to be able to have just the more simpler regimen and allow them to get back to their life. So in summary, a mix of new indications, strong execution by the partners, and the availability of sub-Q to really penetrate into earlier lines of therapy where patients tend to stay on therapy longer. And then on the auto-injector side? Oh, sorry, on the auto-injectors, yeah. I mentioned on the call, Corinne, we are continuing discussions both with the high-volume auto-injector and also small-volume auto-injector. Similarly to comments I made on the enhanced discussions, there just always is a process we go through as the companies go through their technical evaluation process. and then their decision process. So we're moving our way through those processes with those companies. And so no updates on that today, but continuing to make progress and still remain very confident we're going to be signing and announcing deals.

Thank you. Your next question comes from the line of Mitchell Kapoor of HC Rainwright. Your line is open.

Hey, everyone. Thanks for taking the question. Just wanted to know a little bit more about the MDACE platform opportunity. Can you just give a little context to how big or narrow of an opportunity this might be based on how many types of opportunities might be out there for this when you do have the enhanced platform and the eligible partners that were likely focused on that side of the business for the BB partnerships?

Yeah, thanks, Mitch. And what we've talked about is the fact that we do anticipate Enhance will continue to be what people will come and want to license. It's a gold standard. It's the most regulatory and commercially de-risked. So that is where our primary focus is. But we are aware that there are companies who may be considering developing a modified hyaluronidase. And in that instance, they may not want to work with Enhance or they may not be able to work with Enhance, but that's why they've chosen this modified hyaluronidase. But if they're using a modified hyaluronidase, we believe they will be using some of our modified hyaluronidase IP, and that's why we have made these licenses available to them. So we don't think this is, in terms of the number of deals, going to be like we do with Enhance, and we're talking about new partners, you know, with the frequency of which we've done over the years, Mitch, but for anyone who is developing or thinking about developing a drug with a modified hyaluronidase, that's going to be the opportunity for us. It's an emerging field, and so we can't really comment on how many people we think will want to do that. But the great news is it's another growth driver for us if companies are developing modified hyaluronidase sub-Q drugs, copying what we have been doing with Enhance.

Great. Thank you for taking the question, and congrats on the quarter.

Thank you. Your next question comes from the line of Mohit Bensal of Wells Fargo. Your line is open.

Great. Thank you very much for taking my question. I have two questions. So one is, how should we think about your guidance update philosophy going forward? Because I understand that you'll be providing guidance for 25 as next year rolls over, but should we be expecting updates for subsequent years as well as the expectations change? That's number one. And number two, for the MDIS platform, how differentiated it is from your enhanced platform? I'm asking from the point of view of your existing partners who have exclusive licensing with certain products. If it kind of infringes upon that, what gives you comfort that your existing partners would be fine with that?

Yes, I'll ask Nicole to comment on your question on the guidance, and I'll talk about MDAS.

Yes, thanks for the question. Okay, so from a guidance perspective today, we are focused on the third quarter results and the full year updated guidance, which we're really excited to raise for top line and bottom line for the full year. And you saw we do republish our five-year projections. Those are unchanged at the moment, but we continue to evaluate those in the new year. We'll give more line of sight and color into our updated expectations for 2025. All right.

And maybe I'll take a step back and just say, you know, we talked about all of the experiments that we did and the experiments that we did on the human hyaluronidase area. And we came up with Enhance that we patented, and that's a truncated human hyaluronidase. But we also did lots of experiments, thousands and thousands of experiments on different structures of hyaluronidases, and we called those our modified hyaluronidase. So Enhance has got one structure. The modified hyaluronidases have different structure from Enhance. And when we have licensed Enhance, we are only licensing the IP to the structure and the activities that are related to that specific Enhance structure mojit. So that's why our partners are not upset or surprised or anything because they're totally different products and patent portfolios, firstly. Now, our enhanced partners do not need and unlikely to want the MDase portfolio because they have enhanced, which does what it needs to do, which is this delivery of drugs, high-volume rapid sub-Q delivery. But there are some people and partners and makers of drugs and biologics who perhaps can't work in enhanced or don't want to work in enhanced and have chosen or will choose to work in a modified hyaluronidase. And what we wanted everyone to recognize is because of our pioneering work in this area, we have actually got an extensive patent portfolio that covers many modified hyaluronidases. And so for those companies, if they want to develop a modified hyaluronidase for doing the same thing as Enhance, which is the rapid large volume sub-delivery, we wanted to make them aware that we are open and willing to license our patents that relate to the modified hyaluronidase So it's a different product. It's a different structure. But Halazim was really the pioneer of making these new offerings that have enabled such an important advancement for patients. So let me just check in and see. Did that clarify for you the difference between these two?

Very helpful. Thank you very much, Helen and Nicole. Really appreciate it.

Thank you.

Your next question comes from the line of Jessica Fai of JPMorgan. Your line is open.

Hey, guys. This is Nasan. I'm for Jessica Fai. Congratulations on a strong quarter. My question goes back to M-Daze. I think, can you just give us examples of how, in what case would a partner be unable to work with Enhance? I think I've always thought about Enhance giving exclusive targets as a sort of defensive for how it's attractive and defensive for its partners. So for M-Days, wouldn't it give sort of like a, you know, escape hatch, if you will, for competitors? And then secondly, I noticed that for the collaboration revenue guidance, the top range came down a little bit. Can you just talk about a little bit like what is driving that? Thank you.

Yeah. So, with regard to the situation where people couldn't work within HANZ, and I think it's a great question, Aimee, you're quite right. Because we do the exclusive targets, if somebody was unable to work with us because we had already licensed an exclusive target, they might choose to work with a modified hyaluronidase. What we are doing here, however, is not enabling any partner to work and develop a modified hyaluronidase sub-Q-enabled drug against that target. We are simply, because we're not supporting them from a clinical development perspective, and we're also not supplying the API We are simply making them aware that if they want to go down that path, we have got strong IP in that area that is available for license. And this is why, as we have conversed and shared this approach with our current partners, we have really received no pushback or concerns that have been voiced on it because we're not enabling and supporting the development of drugs that are doing anything against the exclusive license of Enhance. We are simply recognizing and seeking to create value for halazine from our inventions that were done all those years ago related to the modified hyaluronidases. So I hope that clarified that. In terms of the guidance ranges, yes. Where we sit today, we've got a line of sight to 130 to 150 million. We're continuing, as I mentioned earlier, to work hard to gain new deals and additional new nominations. But that was our best estimate. based on where we are today for how the year is going to end. We certainly are going to be nicely above 130 in terms of collaborations, and so we're definitely fully in line with our original guidance. We just tightened the range a little.

Your last question comes from the line of David Risinger of LeRinc Partners. Your line is open.

Thanks very much. So my key questions have been asked. So I just wanted to ask about product sales. So if you could just educate a little bit more, Helen, with respect to why product sales are flattish in 2024 and then why they are expected to grow by 50% over the next four years. So I see your 2028 target for revenue is up. about 50% from $300 million this year to roughly $450 million in 28. Thanks so much.

That is a great question. I'm going to pass over to Nicole.

Yeah, thanks, David. So in product sales, what you see in product sales are One, the products that we sell to our collaboration partners, so our API and our devices, that is where we've talked about historically those can be lumpy quarter over quarter. We are making investments to have lower cost API for our partners. So over the longer term, that revenue stream will actually decline for us because as we make lower cost materials, that gets passed on to our partners in savings. So that is one of the drivers in product sales. And then also we have our proprietary product sales. Those are the sales that you see annually year over year are increasing and also trending this year in line with our expectations for the full year. I will point out that our proprietary product sales, you saw a slight decrease in sequential quarters in the third quarter, and that's due to seasonality that we historically experience in the third quarter where we do see a dip in demand in the summer months, and that is a part of our plans, and you'll see that in the results for the third quarter.

With no further questions, this concludes our Q&A session, and this also concludes today's conference call. You may now disconnect.