Halozyme Therapeutics Q4 2024 Earnings Call Transcript

Quartr
Provided by Quartr
February 18, 2025

There are 8 speakers on the call.

Operator

Good afternoon. My name is Karen and I will be your conference operator today. At this time, I would like to welcome everyone to the Halozyme Fourth Quarter and Full Year twenty twenty four Financial and Operating Results Conference Call. Please note, this event is being recorded. I will now turn the call over to Tram Bhui, Halozyme's Vice President of Investor Relations and Corporate Communications.

Operator

Please go ahead.

Speaker 1

Thank you, operator. Good afternoon, and welcome to our fourth quarter and full year twenty twenty four 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 Doctor. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update in our business and Nicole LaBrasse, our Chief Financial Officer, will review our financial results as well as our outlook.

Speaker 1

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 Doctor.

Speaker 1

Helen Toiley.

Speaker 2

Thank you, Tom, and good afternoon, everyone. Our strong fourth quarter results concluded what proved to be an exceptional year for Halozyme. I will start by recapping our record breaking performance in 2024. Total revenue exceeded $1,000,000,000 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 full year results exceeded our raised guidance for royalty revenue, adjusted EBITDA and non GAAP EPS.

Speaker 2

We estimate that one million patients have now received drugs delivered subcutaneously with N Hance, establishing 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 with N 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 twenty twenty nine.

Speaker 2

And we also remain confident in the opportunity for The U. S. Patent reissue, which will have the same effect of extending full royalty rate, in this case, from September of twenty twenty seven to March of twenty twenty nine, 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 SaaS's few financial highlights before I provide more details on the key business drivers.

Speaker 2

Our strong fourth quarter performance resulted in record full year 2024 results. Strong royalty revenue growth of 27% in 2024 resulted in $571,000,000 in royalty revenue, exceeding our raised guidance, and that was a key driver of total revenues exceeding $1,000,000,000 And this strong revenue performance coupled with our careful management of expenses resulted in 2024 net income increasing an impressive 58% year over year to $444,000,000 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 $1,150,000,000 to $1,225,000,000 representing growth of 13% to 21% year over year. This continued strong growth will be primarily driven by three products: DARZLEX Subcutaneous, FESGO and five GAR HYTURLO. Let me begin with DARZLEX on Slide five.

Speaker 2

For the fourth quarter of twenty twenty four, Johnson and Johnson reported worldwide sales of DARZLEX grew almost 24% on an operational basis to $3,100,000,000 with full year revenue reaching $11,700,000,000 We are delighted that DARZLEX growth and total revenue was driven by demand for DARZLEX subcutaneous with ENHANZE, which represents 95% share of total DARZLEX 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. DARZALEX now represents J and J's largest product with strong continued growth projected for many years. This growth is a result of investments Johnson and Johnson has made in new studies to increase access to DARZALEX Subcutaneous with ENHANZE for more early stage and frontline patients, further expanding the commercial opportunity. As examples, in 2024, DARZALEX Subcutaneous with ENHANZE gained U.

Speaker 2

S. 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 U. S.

Speaker 2

And European approval for smoldering multiple myeloma. Each of these represent a compelling growth opportunity for DARZLEX Subcutaneous. These advancements support analyst projections of more than $17,000,000,000 in total revenue for DARZALEX in 2028, with virtually all of this coming from DARZALEX Subcutaneous with Enhance. And recall, we project earning royalties in DARZALEX subcutaneous until 02/1932. I'll now move to our second key driver, which is Roche's FESGO, shown on Slide six.

Speaker 2

FESGO is the combined therapy of PERJETA, HERCEPTIN and ENHANZE, which is given in a single seven minute subcutaneous injection for the treatment of breast cancer. We believe FESGO is an underappreciated asset that has been garnering growing adoption globally. In the fourth quarter, Roche reported that Fesco grew to CHF 500,000,000, representing an increase of 72% year over year and reached CHF 1,700,000,000.0 or approximately US2 billion dollars for full year 2024. Fezco 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.

Speaker 2

With these strong results and expectations for continued growth, analysts project Fezco will reach $3,400,000,000 in revenue in 2028, all of which is substantiated with Enhance. And recall, we project earning mid single digit royalties on Fezco until 02/1930. Let me now transition to argenx's VIVEGART and VIVEGART HITRULA with ENHANZE on Slide seven. Argenx pre announced preliminary results in January with total VIVEGART, including VIVEGART HITRULA with ENHANZE fourth quarter sales reaching $737,000,000 for full year revenue of $2,200,000,000 This remarkable launch success is driven predominantly by continued growth and adoption in generalized myasthenia gravis, where Vibegart hetrula with N HANZE was approved in 2023. Vibegart hetrula with N HANZE is playing a key role in Vibegart growth by expanding the number of physicians using Vibegart, adding those who do not wish to or who cannot administer IV infusions.

Speaker 2

The ease of use of subcutaneous delivery is also enabling VIVEGAR to move earlier in the treatment paradigm, expanding the addressable population. And note that we project earning royalties in VIVEGAR HETRULO through the early two thousand and forty. Further innovation that will expand the VIVEGAR HETRULO with ENHANZE opportunity is projected in The United States in April of twenty twenty five with the potential FDA approval of a prefilled syringe treatment option for five garthetrula with enhanced for all of the currently approved indications. Halozyme co created the prefilled syringe with Ergenics, which may allow patients self administration in just twenty seconds. Argenx is also expecting the prefilled syringe to be approved in Europe, Japan and Canada in 2025.

Speaker 2

Halozyme 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 demyelinating polyneuropathy or CIDP, which is a subcutaneous five car hetrula with an HANDS only indication. This is an exciting new growth driver that is really just beginning following the mid-twenty twenty four approval in The United States and the end of twenty twenty four approval in Japan. Argenx has seen strong interest in adoption with more than one thousand CIDP patients already receiving VIVE GAR HERTRULO. The patient testimonials shared by argenx tell a powerful story of how VIVEGAR HETRULO is helping CIDP patients regain their lives.

Speaker 2

Strong progress has been made in gaining that all important coverage and access with now ninety percent of covered lives having access to Vipart Hetulof for CIDP under favorable or highly favorable policies. The brand is also benefiting from a halo effect of argenx being able to promote CIDP next to generalized myosin air gravis to open up new prescribers. Already, twenty five percent of prescribers for CIDP were physicians who had not previously been seen by argenx. In 2025, argenx 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, Halozyme's journey with argenx on their next wave of innovation for VIVE GARP highlights the many exciting opportunities for many years to come with multiple active subcutaneous programs with N HANDS in development, including in thyroid eye disease and ocular myasthenia gravis.

Speaker 2

And as we look out even further, our journey with argenx was enhanced in 2024 with four new nominations with NHAANZE, which creates new opportunity and reinforces our leadership position at argenx'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 Aukritus Sanutvo, Tecentriq Hybriza and Opdivo Qvantage. Based on benchmarks, we assume it will take six to nine months in The United States and more than twelve 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.

Speaker 2

Let me begin with Roche's Ocrevus Synuvo, which received EMA and FDA approval for the treatment of multiple sclerosis in 2024. Ocrevus Synuvo with ENHANZE allows for an approximately ten minute subcutaneous injection, which compares with multiple hour infusion that is typically required for the IV administration time. Roche has been very consistent with their comments that they believe the subcutaneous formulation with ENHANZE 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 two thousand five hundred patients on Ocrevus Synuvo globally. In The United States, they are seeing positive signals with fifty percent share of new Ocreepus subcutaneous patients being naive to Ocreepus.

Speaker 2

This is great news for two reasons. Firstly, it demonstrates market expansion and growth for Ocreepus, which is being driven by subcutaneous subcutaneous de novo. Secondly, the remaining fifty percent 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 Ocravis' Novo represents an incremental CHF2 billion or more than CHF2 billion opportunity for the brand.

Speaker 2

With full year 2024 sales reaching CHF 6,700,000,000.0 or approximately US7.7 billion dollars this represents a very attractive growth opportunity for Halozyme. We project receiving mid single digit royalties on Orgovis Zenuvo until 02/1930 and at a step down rate until at least 02/1934. We are also excited that Roche's TecentreTybriza with ENHANZE gained FDA approval in September of twenty twenty four. 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 Tecentriq revenue represented CHF3.6 billion or approximately US4 billion dollars in 2024.

Speaker 2

Roche plans to drive IV to subcu conversion and believes that subcutaneous formulation will be protective of the brand. And recall that we project receiving royalties onto Centric Hydreza until 02/1940. Moving now to Bristol Myers Squibbbs of Devo QVANTAGE, which was approved by the FDA in December of twenty twenty four and represents our ninth approved product with N HANZE. I will also note that the European submission is currently under review. Bristol Myers Squibb commented recently that they are 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.

Speaker 2

With their sales team out in the field relaying the benefits of UPDIVO QVANTAGE, 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 are treated in combination with the urafide such as in first line metastatic melanoma and renal cell carcinoma. Bristol expects that thirty percent 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 twenty twenty five after they transition to a permanent J code in July. Opdivo Qvantage represents another very attractive conversion opportunity for Halozyme.

Speaker 2

Opdivo, which is a brand name for IV nivolumab, grew 7% excluding FX in the fourth quarter to $2,500,000,000 and reached $9,300,000,000 in annual sales in 2024. Now, I may also take this opportunity to comment on amivantamab subcutaneous, which would represent our TENS approved partner product. Recall amivantamab is included in our longer term projections as we consider it derisked following strong Phase III data. Recently, Johnson and Johnson announced that they had received a positive opinion from the Committee for Medicinal Product of Human Use of the European Medicines Agency recommending an extension of marketing authorization for the subcutaneous formulation of amivantamab with ENHANZE in combination with olacetranib in the first line treatment of adult patients with advanced non small cell lung cancer. The European Commission approval is typically granted sixty seven days after the recommendation, which would support approval in the April 2025 timeframe.

Speaker 2

We're excited for the amivantamab subcu potential approval and what this could mean for patients. The subcutaneous formulation of 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 fivefold reduction in infusion related reactions. Moving now to The U. S.

Speaker 2

Timeline. In December, Johnson and 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 and 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. G and J has publicly commented that they believe amivantamab has a $5,000,000,000 revenue potential.

Speaker 2

Moving now to Slide 10. We are confident in reaching our $1,000,000,000 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 FESGOPE, which represent a $20,000,000,000 total opportunity and the layering of the four recent launches of VIVEGAR Heitrilo, TECENDRIK HYBRISA, Ocrevus Synuvo and Opdivo Qvantage plus the upcoming potential launch of ambivantamab subcutaneous. Analysts project these five products represent an even greater opportunity in 2028 of $35,000,000,000 I know that you agree that the near term revenue growth in 2028 is very strong. And I often get the question, what's next?

Speaker 2

The good news is that the launched and launching products that we've just reviewed continue to provide very strong revenue post-twenty twenty eight, and we project several current pipeline products will contribute additional meaningful revenue post-twenty twenty eight too. Let me walk you through some of the specifics, which are shown on Slide 11. Fezco is projected to continue to grow post-twenty '28 and earn Halozyme royalties at its full, unchanged mid single digit rate until 02/1930. DARZALEX VASPERO and subcutaneous is projected to remain our largest revenue driver until 02/1932 in Europe earning Halozyme royalties at its full unchanged mid single rate until March of twenty twenty nine and to continue to earn as royalties at half that rate until 02/1932. 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 twenty twenty nine and continue to earn as royalties at half that rate until 02/1932.

Speaker 2

This is not currently reflected in our long term guidance. Vibar Hatrulho is projected to earn Halozyme royalties for all of its indications sold either in the vial or through the prefilled syringe at its full, unchanged current mid single digit royalty rate until March 2029 and then to continue to earn royalties until 02/1933 at a mid single digit rate even after a step down in the royalty rate. Royalties will continue until the 2040s after further step down in rate. Moving to Okada Senuvo, this is projected to earn Halozyme royalties at the full mid single digit rate until 02/1930 and at a step down rate until at least 02/1934. And with Tecentriq Hybrisa projected to earn Halozyme royalties at its full mid single digit rate until the 2040s and ObsEva Q Vantage projected to earn Halozyme royalties until at least 02/1934.

Speaker 2

You can see why we project continued strong revenue from the current launch products beyond 2028. In addition, we are confident that the more advanced derisk products from our pipeline will contribute revenue post 2028. For example, Opdivo fixed dose combination with the rilatilimab and TAK-eight eighty one are two additional derisk revenue growth drivers post-twenty twenty eight. And we also anticipate additional products from our current Phase one 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.

Speaker 2

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 Enhance, recall we have two paths for growth. The first is gaining new nominations by current partners and the second is through signing new deals.

Speaker 2

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-twenty twenty nine. And moving to the new enhanced deals, we are in active discussions with multiple companies. In 2025, our goal is to advance the collaboration and licensing agreements with at least one.

Speaker 2

And moving to our high volume auto injector, our goal is to advance to a development agreement this year. And often that's why we have 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.

Speaker 2

This accomplishment has significantly derisked the high volume of the 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.

Speaker 1

Thank you, Helen. Our strong fourth quarter results marked the end to another record year for the company with the achievement of more than $1,000,000,000 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 $468,000,000 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 $1,000,000,000 in royalty revenue with our achievements to date.

Speaker 1

Let me now turn to our detailed fourth quarter results on Slide 12. Revenue grew 30% to $298,000,000 compared to $230,000,000 in the prior year period. Growth was primarily driven by royalty revenue, up 40% to $170,000,000 and higher revenues under collaborative agreements, up 70% to $48,000,000 mainly due to more milestones achieved for enhanced sale based milestones. The continued commercial success of Subcutaneous DARZLEX and FEZCO and early growth of VIVGART HITULO for gMG, which launched in 2023, were the main drivers for our royalty revenue growth for the quarter. Adjusted EBITDA increased 61% to $196,000,000 in the fourth quarter

Operator

from $122,000,000

Speaker 1

in the prior year period, driven by high gross 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 $596,000,000 on 12/31/2024, compared to three thirty six million dollars on 12/31/2023. Our net debt position was $929,000,000 with a net leverage ratio of 1.3 times. The increase in cash was primarily a result of cash generated from operations, offset by $250,000,000 deployed for share repurchases. Turning now to Slide 13 for our detailed financial results for the full year 2024.

Speaker 1

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 $1,015,000,000 in 2024, off an already substantial revenue base in 2023 of $829,000,000 Robust growth was primarily driven by 27% growth in royalty revenue, totaling $571,000,000 as well as higher revenues under collaborative agreements and higher sales of proprietary products. Research and development expenses were $79,000,000 compared to $76,000,000 in 2023, primarily due to planned investments in N HANZE related to the development of our new high yield RU PH20 manufacturing process. Selling, general and administrative expenses were $154,000,000 compared to $149,000,000 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 $632,000,000 from $426,000,000 in 2023.

Speaker 1

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 $2.1 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 $1,150,000,000 to $1,225,000,000 representing year over year growth of 13% to 21% royalty revenues of $725,000,000 to $750,000,000 representing year over year growth of 27% to 31%. As Helen touched on, we project DARZLEX, SubQ and Fezco will continue to grow substantially in 2025. And for the first time, VIVGART HITRULO with ENHANCE is expected to be the largest royalty dollar growth driver.

Speaker 1

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 $755,000,000 and $8.00 $5,000,000 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 twenty twenty four 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 twenty twenty four to the first quarter of twenty twenty five 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 twenty twenty five.

Speaker 1

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 $1,000,000,000 we just achieved to $1,700,000,000 to $1,900,000,000 in 2028. Let me conclude on Slide 16 and provide an update on our share repurchases. In December of twenty twenty four, we entered into a $250,000,000 ASR under the $750,000,000 approved program from February of twenty twenty four. This will complete by the end of the first quarter of twenty twenty five.

Speaker 1

Since the inception of the first program in 2019, we have returned 1,550,000,000 in share repurchases, an average of approximately $250,000,000 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 derisks our capital position as we have capacity to cover our debt obligations without overextending our resources as evidenced by our low net leverage profile of 1.3 times at year end.

Speaker 1

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 and A. With that, I'll now turn the call back over to Helen.

Speaker 2

Thank you, Nicole. We're truly at a remarkable time in Halozyme history with nine products now approved and almost one launched in multiple regions. Our high twenty twenty five revenue and royalty growth is driven by just three of these products DARZALEX Subcutaneous, Fezco and VIVEGAR HERTRULO, each of which bring durable revenues until at least 02/1930 and in the case of Vibegar Herculo into the 2040s. Our confidence and conviction in our multiyear guidance was further reinforced with the twenty twenty four approvals of TECENTRI KIBRZA, Ocovis Zenuvo and Opdivo Qvantage. Next up will be amivantamab subcu following the successful completion of the regulatory reviews.

Speaker 2

This adds four additional durable royalty streams, which will begin to contribute meaningfully in 2026 and continue to at least the mid-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 Halozyme 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.

Operator

The first question comes from Sean Lemann from Morgan Stanley. Your line is open.

Speaker 3

Hi, Helen, Nicole and Tram. Hope you're all well and 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 what's beyond that and what sort of terminal value should you think about with Halozyme?

Speaker 3

So looking at your Slide 11 and some of the issues that are going on there, what's your confidence around some of the new uses, for example, we've got that you've detailed today and maybe even some of the further argenx related programs that might come on board to mitigate any reduction in sort of earnings beyond that sort of 2028 period 02/1930 period.

Speaker 2

Great. Thanks, Simon. And welcome to the coverage of Halozyme. It's a great question. And in the prepared remarks, I covered that the way we think about post-twenty twenty is really to look at the current 10 products that are approved or soon to be approved with amifantumab sub Q and consider that they are going to continue to be contributing considerably at that time.

Speaker 2

And the slide that we show with the duration and royalty rate really does help bring that picture into perspective showing every product will get royalties until 02/1930. Many of them will go to the mid-2030s and multiple ones will also go to the 2040s. Now for VIVE GAR in particular, that is just considering GMG and CIDP. We are aware and we've got six products that are public that are already subcu development plans are soon to start with argenx. But I do think we're going to have to wait for the results.

Speaker 2

On a mechanistic basis, I have high confidence they're 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 Rolatinib AbbVivo and TAK-eight eighty one, those are highly derisked as they already are approved, as an IV and other formats. And so those will layer on top.

Speaker 2

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 2028, '20 '20 '9 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

Speaker 3

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

Speaker 2

Thanks Sean.

Operator

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

Speaker 4

Great. Thanks for taking the question. Congrats on the strong quarter. Maybe really quickly on BD, can you just tell us a bit more what about what does the inclusion or integration of that small volume auto injector 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 auto injector?

Speaker 4

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?

Speaker 2

Yes. Thanks, Brandon. And obviously, we're excited to announce the small volume of 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 of injector deal, it starts with a development agreement.

Speaker 2

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 the 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 Halozyme. So it will be another revenue stream for Halozyme that would be reflected in product sales. Now that's specific for the small volume auto injector, but that does not need ENHANZE in it necessarily.

Speaker 2

When we think about the opportunity for the high volume auto injector, ENHANZE is the secret sauce for the high volume auto injector to work. And so high volume auto injector deals will be either associated with our current partners who already have ENHANZE or could be with new partners who are licensing ENHANZE 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, product sales once again on the sale of each and every device that we sell. So a nice layering on of both royalty addition and product sales in the case of the high volume auto injector.

Speaker 2

And the current agreement with the small volume auto injector is I think a nice illustration of patients. 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 injector well, high volume loss injectors and also in HANDS. And so we're in conversations with large pharma, with biotech.

Speaker 2

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.

Speaker 4

Okay, great. Thanks very much.

Speaker 1

Thanks, Brent.

Operator

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

Speaker 5

Great. Thank you very much for taking my questions and congrats on all the progress. So couple of questions from my side. One is, Nicole, you mentioned that you're modeling negative 10% royalties for first quarter over fourth quarter. Hello.

Speaker 5

Can you help me understand, what is the what are the dynamics there? Because it has not happened in the past and specifically VIVGUARD and CIDP launch is going really well. That's the first question. And the second question is how are you incorporating pre sales savings transition and its uptake in the guidance because it seems to be going really well? Thank you.

Speaker 1

Yes. 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 re rate, 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.

Speaker 1

The most material impact to us is, from DARZALEX. And we have seen that last year, but as DARZALEX 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.

Speaker 1

So it is just a small portion of the quarter where we see that impact. And then I'll also just highlight, too, we also see an impact related to our epi 10 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.

Speaker 1

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?

Speaker 2

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

Speaker 5

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

Speaker 2

Yes. Based on public comments that argenx has made, they are expecting the pre filled syringe approval in April of this year. I think we talked in the past that we meet with our partners towards the end of the year and they give us their projections, a range for performance in 2025. And so we understand that argenx will have contemplated that in the information and the range they gave us. So, while we can't get into specifics, it does our guidance already reflects the potential increase that prefilled syringe could bring.

Speaker 2

And I think what people are I think very excited about it can bring the potential for a twenty second at home injection by patients 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.

Speaker 5

Great. Thank you, sir. Thank you. Thanks, Helen and Nicole.

Operator

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

Speaker 1

Hey guys, good evening. Thanks for taking my questions. With the small volume auto injector deal you signed with an existing partner for 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?

Speaker 1

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.

Speaker 2

All right, Tessa. I'll take the first one. So 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.

Speaker 2

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?

Speaker 1

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.

Operator

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

Speaker 6

Hey, guys. Thanks for taking my question and congrats on the progress this year. In light of the fact that Vivint's overall brand sales in 4Q had a noticeable inflection and your comments on how VIVGARD HYTULA will be the biggest growth contributor in 2025, just want to get your take on whether 2025 may be the year that the subcu formulation exceeds the IV sales. To the extent that you can, if you could add any color on that, I know back in November, argenx mentioned that the IV still comprises the bulk of sales, but wondering if you see any change in the mix over the course of 2025?

Speaker 2

Yes. Thanks for that question, Mike. I mean, obviously, the comments that argenx has made, we're delighted with the success and uptake that we're seeing with VIVE GART, both in CIDP and at gMG. In terms of Wayne VIVE GART subcu could take over IV, as argenx has not provided any perspective on that, it wouldn't be appropriate for us to comment on that. But certainly, 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 1,000 patients on treatment, we are very excited to when that event actually happens.

Speaker 2

But I can't communicate when that's anticipated.

Speaker 6

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?

Speaker 6

Thank you.

Speaker 2

Yes. 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 our 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.

Speaker 6

Got it. Thanks so much.

Operator

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

Speaker 7

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 a small number of products versus broadly leverageable across multiple partnering conversations? And then second question for me is, I guess for Nicole, just any color you can give on what's remaining on the $250,000,000 accelerated buyback? Thanks.

Speaker 2

Yes. 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.

Speaker 2

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?

Speaker 1

Yes. Thanks, Jason. On the ASR, so I can't share specifically how much our bank has executed through the $250,000,000 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 were retired, at the start of the program.

Speaker 1

At the final settlement date, we will then calculate with our bank what the final, average purchase price was and the final, the final delivery of the shares. So we 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 $250,000,000

Speaker 7

Great. Thank you.

Operator

The next question comes from Mitchell Kapoor from H. C. Wainwright. Your line is open.

Speaker 7

Good afternoon. This is Dan on for Mitch. Congratulations on the earnings feed. Thanks for taking our questions. So when you think about business development, are you more focused on larger deals or groups of smaller deals?

Speaker 7

And are there any contract obligations prohibiting partnering agreements with PD-one BGF bispecific programs? And if not, what's the interest in partnering with one? Thank you.

Speaker 2

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 argenx and vivegard.

Speaker 2

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 nonexclusive arrangements.

Speaker 2

So it'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-one bispecific, based on the exclusive terms of the agreement we have with Bristol, we would not be able to partner on a PD-one bispecific.

Speaker 7

Okay. Thank you very much.

Operator

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

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Earnings Conference Call
Halozyme Therapeutics Q4 2024
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