Ligand Pharmaceuticals Inc Q3 FY2024 Earnings Call

Good morning. My name is Aaron, and I will be your conference operator for today. At this time, I would like to welcome everyone to Ligand's Third Quarter 2024 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question-and-answer session. Thank you. With that, I would like to turn our call over to Melanie Herman, Senior Director of Financial Planning and Analysis. Melanie, you may begin.

Good morning, everyone, and welcome to Ligand's third quarter earnings call. During the call today, we will review the financial results we released before today's market open and offer commentary on our partner pipeline and business development activity, followed by a question and answer session. Our earnings release and a link to today's webcast can be found in the Investor Relations section of our website at ligand.com. With me on the call today are CEO, Todd Davis; Senior Vice President of Investments and Head of Clinical Strategy, Dr. Karen Reeves; and Chief Financial Officer, Tavo Espinoza. This call is being recorded and the audio portion will be archived in the Investors section of our website. On today's call, we will make forward-looking statements regarding our financial results and other matters related to the company's business. Please refer to the Safe Harbor statement related to these forward-looking statements, which are subject to risks and uncertainties. We remind you that actual events or results may differ materially from those projected or discussed and that all forward-looking statements are based upon current available information. Ligand assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Ligand filed with the Securities and Exchange Commission or SEC that can be found on Ligand's website at ligand.com or on the SEC's website at sec.gov. With that, I will turn the call over to Todd.

Thank you, Melanie, and welcome to everyone on the call. I'm delighted to report one of the best quarters of performance in Ligand's history. Slide 3 summarizes our strong business momentum in the third quarter. We grew total revenue by 58% over the prior year and we increased guidance for the second time this year. We are well-capitalized with access to over $300 million in capital to continue to execute on our strategy of acquiring high-value royalty-generating assets. Our growing roster of major commercial programs gives us predictable and growing royalty revenue that is the foundation for our strong financial performance this quarter. Tavo will delve more into our financial performance later on the call. I'm extremely proud of our team and the many accomplishments we've achieved in the last 18 months. We have invested almost $300 million since last fall and have added several programs to our pipeline, including QARZIBA, which came from our immediately accretive acquisition of APEIRON Biologics this summer and our transaction with the Ohtuvayre Inventors, increasing our royalty rate on that drug to nearly 3%. Additionally, our efforts to incubate telcos and ready ZELSUVMI for commercial launch continue in earnest, and we aim to select a partner that can launch ZELSUVMI in the first half of 2025. This drug addresses significant unmet need in molluscum contagiosum as the first at-home prescription product for this condition. On our second-quarter earnings call, we talked about two important FDA approvals within our portfolio, Verona Pharma's Ohtuvayre and Merck's CAPVAXIVE. We are pleased to report that both products were successfully launched during the third quarter. Additionally, Merck announced in October that the CDC's Advisory Committee on Immunization Practices or ACIP has recommended CAPVAXIVE for adult pneumococcal vaccination in adults 50 years of age and older. The ACIP's recommendation lowers the current age-based recommendation from 65 and as stated by Merck has the potential to be a practice-changing milestone that may improve vaccination rates. Analysts estimate that both Ohtuvayre and CAPVAXIVE have blockbuster sales potential, and we believe these products will be meaningful contributors to our royalty revenue over the next few years. Dr. Karen Reeves will provide more details on these and other programs later in the call. Another important milestone this quarter was the full FDA approval and label expansion of Travere’s FILSPARI. This therapy has the potential to become foundational care in IgA nephropathy, a rare kidney disease that affects up to 150,000 people in the US and is one of the most common glomerular diseases in Europe and Japan. We continue to see more widespread adoption of this groundbreaking therapy as evidenced by the recent Swiss approval of FILSPARI and look forward to the continued European launch in the coming months. We are also excited about FILSPARI's potential indication expansion in new focal segmental glomerulosclerosis, or FSGS. FSGS is a rare kidney disease that has a high risk of progression to kidney failure. There are no FDA-approved therapies for FSGS. Dr. Karen Reeves attended the PARASOL scientific workshop meeting last month, which convened various stakeholder groups, including the FDA, to discuss endpoints for the FSGS clinical trials. We are encouraged by the outcomes from this meeting, and Travere is planning to reengage with the FDA later this year about a potential path forward for FILSPARI in FSGS. All of these recent developments reinforce what we believe FILSPARI will be a significant driver of revenue for us over the next several years. Ligand has a 9% royalty on all indications of FILSPARI. Turning to Slide 4, I would like to remind our listeners about Ligand's strategic differentiation. We are a biopharmaceutical company that seeks to generate profitable, diversified, compounding growth. We target late-stage development assets and commercial assets with superior risk-reward profiles. Our highly qualified team brings decades of investing experience along with clinical, operational, and regulatory expertise, as well as strong origination networks throughout the industry. We continue to execute on our strategy of acquiring high-growth, low-OpEx assets, a plan we outlined nearly 2 years ago. There is a sizable demand for royalty capital in the life science industry, which allows us to invest selectively as we offer a differentiated capital solution that traditional investors do not typically provide. Our capable team originates, diligences, and negotiates proprietary investments with customized investment structures and novel tactics to create investment opportunities. Our acquisition of APEIRON is a prime example of this. It is also important to emphasize that we do this while maintaining low operating expenses. Our structural approach to investing is a very small percentage of the total capital that is invested in life science companies today. Therefore, we believe our model is differentiated, scalable, and offers immense growth potential for years to come. Turning to Slide 5 for our royalty revenue outlook. We've made substantial progress towards meeting or exceeding the longer-term growth goals we outlined in our Analyst Day in December of 2023. Our investment origination seeks and identifies high-value clinical products that will offer significant positive clinical impact. Looking at the third quarter, we see the results of this focus as we saw an increase in Wall Street consensus estimates on several of our partner products, including Travere FILSPARI, which, as I mentioned earlier, has received full approval by the FDA, has been granted conditional approval by the European Commission and Swiss authorities. We also added several major new commercial products to our portfolio, including QARZIBA, CAPVAXIVE, and Ohtuvayre, which will positively impact our royalty revenues over the coming years. We will provide an updated long-term view that incorporates these recent events at our Investor Day on December 10. As I've shared previously, we believe our long-term royalty revenue growth is on pace to exceed the 22% compounded annual growth rate we outlined last December. The existing portfolio alone supports a royalty revenue CAGR of 18%, which is above our previous estimate of 16%. Further investments should add at least 4% to this with potential upside on top of the current outlook. Our business development team is constantly searching for attractive new investments. In conclusion, we are all proud of what we've accomplished since we began restructuring and executing on this new strategy in the fourth quarter of 2022, and we are very optimistic about our future prospects. Ligand's pipeline remains robust. We are currently reviewing over 20 investment opportunities representing in excess of $800 million of investment potential. The operating leverage came from our lean corporate cost structure is expected to result in adjusted EPS of greater than $10 per share in 2028. I'll now turn it over to Dr. Karen Reeves for our portfolio update.

Thank you, Todd. Today, we'd like to highlight a few key commercial products in our portfolio. Turning to Slide 6, I would like to go into more detail on Travere’s FILSPARI, where we are entitled to a 9% royalty on global net product sales. In September this year, the FDA granted full approval for Travere’s FILSPARI, an endothelin and angiotensin II receptor antagonist to slow kidney function decline in adults with primary immunoglobulin A nephropathy, IgAN, who are at risk for disease progression. This is the first and only non-immunosuppressive therapy approved for the treatment of IgAN, a rare kidney disease that leads to diminished kidney filtering, proteinuria, and progressive kidney function loss. The FDA's full approval for FILSPARI expands the indication to include without qualifiers patients with IgAN at risk for disease progression. Moreover, with full approval, FILSPARI is now indicated to slow kidney function decline from the previous only reduced proteinuria. Importantly, the full approval label details the long-term durable benefit of FILSPARI on proteinuria and kidney function in the two-year, PROTECT study, which compared FILSPARI with Irbesartan and angiotensin 2 receptor blocker. Travere estimates that this broader label means that the addressable FILSPARI IgAN patient population could nearly double. We believe full approval will allow for more detailed physician communications regarding FILSPARI, and its sustained proteinuria reduction as well as long-term kidney function preservation should give physicians greater confidence to prescribe the drug. FILSPARI was also recently recommended as a foundational kidney-targeted therapy for IgAN in the draft Kidney Disease Improving Global Outcomes, KDIGO 2024 guidelines, which is a very important positive development that should drive further adoption of the drug. Outside the US, the European Commission granted conditional marketing authorization for FILSPARI for IgAN in April. During the third quarter, Travere announced that their European commercial partner CSL Vifor launched FILSPARI in Germany and Austria and that Switzerland achieved temporary marketing approval in October. Additionally, Travere reported that they have submitted a supplemental NDA requesting modification to the REMS liver monitoring requirement. We are also excited about initial data shared by Travere showing that FILSPARI induced further proteinuria reduction when used with SGLT2 inhibitors supportive of the flexibility to be used in combination with other medicines. Turning to Slide 7, FILSPARI is also being evaluated in a second important indication, focal segmental glomerulosclerosis or FSGS. FSGS is a rare complex kidney disorder and leading cause of kidney failure affecting children and adults. There are currently no FDA-approved pharmacologic treatments for FSGS. Prompted by the urgency of no approved drugs and the need to develop FSGS treatments with alternative proteinuria-based endpoints, a group known as the PARASOL Initiative was formed as an international collaboration of NextCure and other global kidney foundations, patients, nephrologists, academia, scientists, and regulators including the FDA. The PARASOL team reported at a scientific workshop with the FDA, announcing these existing global databases for more than 1600 children and adults with FSGS. A key finding was that the reduction of proteinuria over 24 months is associated with the reduction in the risk of kidney failure. The goal of PARASOL is to find quantitative relationships between biomarkers and long-term outcomes to support proteinuria endpoints as a basis for accelerated and traditional approval. On their recent earnings call, Travere stated that they have scheduled a Type C meeting with the FDA to discuss a regulatory pathway for FILSPARI and FSGS and that they are preparing a supplemental NDA. There are estimated to be more than 40,000 FSGS patients in the United States and a similar number in Europe. Approximately half of these would be candidates for FILSPARI. Approval of FILSPARI for FSGS would represent the first FDA-approved treatment, an important milestone for the long-waiting FSGS community. Turning to Slide 8, I would like to talk about Merck's CAPVAXIVE vaccine. As Todd noted earlier, Merck launched CAPVAXIVE during the third quarter of 2024. CAPVAXIVE is a 21-valent pneumococcal conjugate vaccine for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in the adult population that was approved by the FDA in June. We are entitled to a low-single-digit royalty on worldwide net sales of CAPVAXIVE. Merck is in the early stages of the commercial launch. They mentioned on their Q3 earnings call that the CAPVAXIVE launch is off to an encouraging start and that they expect to get a majority share of the market over time. The other recent and exciting development with CAPVAXIVE is that in October, the CDC's ACIP voted to expand the age-based recommendations for CAPVAXIVE to 50 years of age and older from the previous 65 and older. This will significantly expand the patient population for this vaccine and should accelerate the adoption of CAPVAXIVE over time. Turning to Slide 9, let's look at Verona's Ohtuvayre which was granted FDA approval in June. Ohtuvayre is a dual inhibitor of PD3 and PD4 enzymes that combines bronchodilator and non-steroidal anti-inflammatory effects for the broad indication of maintenance of chronic obstructive pulmonary disease, COPD. Ohtuvayre is the first inhaled product with a novel mechanism of action for the maintenance treatment of COPD in more than 20 years and we believe it has blockbuster commercial potential. We are entitled to a royalty rate of approximately 3% on worldwide sales of Ohtuvayre. From the perspective of product reimbursement, following the end of third quarter, Verona received notification from the Centers for Medicare and Medicaid Services, CMS that its permanent product-specific J-code for Ohtuvayre has been accepted and will be effective January 1, 2025. There is also significant pipeline value in Ohtuvayre to be realized. Verona’s development partner in Greater China Nuance Pharma continues to make great progress and completed enrollment in its pivotal Phase 3 clinical trial evaluating Ohtuvayre for the maintenance treatment of COPD in China. Results from that trial are expected in 2025. At the recent CHEST annual meeting in late October, there were presentations and posters on analyses from Verona's successful Phase 3 ENHANCE studies with Ohtuvayre for the treatment of COPD. The analyses summarize the efficacy and safety of Ohtuvayre in subgroups of COPD patients, including data supporting improvements in lung function, symptoms, and quality of life as well as reductions in the rate of exacerbations regardless of COPD severity, smoking status, and whether or not the patients had chronic bronchitis. Furthermore, an analysis of Ohtuvayre’s impact on reducing exacerbation rates and COPD-related healthcare resource utilization over 48 weeks showed Ohtuvayre decreased the exacerbation rate and healthcare utilization in patients with moderate to severe COPD. Therefore, Ohtuvayre may help decrease the burden of disease for patients and the healthcare system, an estimated cost of $24 billion annually. With that, I will now turn the call over to Tavo for the financial update.

Thanks, Karen. First, I want to highlight that I will be discussing non-GAAP results, which exclude certain items, including stock-based compensation, amortization of intangible assets, amortization or impairment of financial assets or derivatives, and expenses incurred to incubate the Pelthos business amongst others. I encourage you to review the GAAP reconciliation of these non-GAAP measures, which can be found in today's release available on our website. We believe that the adjusted measures can assist investors in analyzing and assessing our past and future core operating performance. The third quarter of 2024 delivered exceptional financial results with continued growth in royalty revenue and an increasingly positive outlook for the year. This strength allowed us to revise our guidance upward for the second time this year, underscoring our confidence and sustained momentum. Total revenues for the third quarter reached $51.8 million representing a 58% increase over Q3, 2023. This growth was driven by a 33% increase in royalty revenue, which reached $31.7 million up from $23.9 million in the same period last year. We reported adjusted earnings per share of $1.84 which is an 80% increase over Q3 2023, and we ended the quarter with a strong balance sheet with almost $350 million in available investable capital when you consider our cash and investments in our credit facility. Turning to Slide 11, key drivers in royalty revenue growth were the addition of QARZIBA to our royalty revenue portfolio in July, coupled with strong performance from Amgen Kyprolis and Travere's FILSPARI. While we are contractually limited from disclosing QARZIBA sales, I can confirm that Q3 sales and the corresponding earned royalty were in line with our July guidance of approximately $1 annualized EPS contribution. Amgen reported $378 million in Kyprolis sales this quarter, marking an 8% increase year over year, largely attributed to robust volume growth outside the United States. We received a tiered royalty on Kyprolis sales from Amgen ranging between 1.5% and 3%. Given Kyprolis’s current annual sales level of approximately $1.5 billion, we achieved a maximum 3% royalty rate in the second half of the year. Travere reported $35.6 million in FILSPARI sales, including 505 new patient start forms, which represented strong sequential growth of 31%. Delphi Research analysts are projecting peak global FILSPARI sales in the range of $500 million to $700 million in IgA nephropathy alone, reinforcing our view that this product could be a significant driver of royalty revenue for us over the coming years. Turning to the two recently approved programs that have expanded our major commercial portfolio. Verona reported a robust start to the US launch of Ohtuvayre, achieving quarterly net sales of $5.6 million with October sales alone exceeding the entire third quarter. Merck also highlighted a promising launch for CAPVAXIVE during their third quarter earnings call. We earned a low-single-digit royalty on both programs and expect them to contribute more meaningfully to our royalty revenue in 2025. Captisol sales came in at $6.3 million down from $8.6 million in Q3 2023, primarily due to the timing of customer orders. Contract revenue for the quarter was $13.5 million driven mainly by a milestone payment from Verona following the commercial launch of Ohtuvayre. Operating expenses increased this quarter with G&A expenses at $24.5 million and R&D expenses at $5.7 million compared to $14.7 million and $5.5 million respectively in Q3 2023. This increase in operating expenses was primarily due to an increase in personnel-related costs as well as continued investments made to incubate the Pelthos business. This quarter's operating expenses also included a $7.8 million non-cash expense stemming primarily from a fair value adjustment on several partner programs from Agenus that will return to them in Q3. On our income statement, this adjustment is reflected as fair value adjustment to partner program derivatives. GAAP net loss in the third quarter of 2024 was $7.2 million or $0.39 per diluted share compared to a GAAP net loss of $10.3 million or $0.59 per diluted share in Q3 2023. This quarter's GAAP net loss was primarily impacted by several non-cash items including a $7.4 million stock award modification expense related to the departure of our former President and COO, an $8 million fair value reduction of Agenus warrants, and the previously mentioned $7.8 million fair value adjustment on our partner program derivatives. Adjusted diluted EPS for the third quarter of 2024 was $1.84 up from $1.02 in Q3 2023. This increase reflects growth in royalty revenue and a $13.5 million milestone earned from the commercial launch of Ohtuvayre, partially offset by an increase in shares outstanding. Turning to the balance sheet. In July, we invested $1 billion to acquire APEIRON Biologics. To partially offset this outlay, we accessed our ATM facility issuing 334,000 shares of common stock at an average price of $105 per share, which contributed $35 million to our cash position. As of September 30, 2024, our cash and short-term investments totaled $220 million including $53 million in holdings of Viking common stock. Turning to Slide 12, and turning to guidance. We are raising our 2024 total revenue forecast to a range of $100 million to $165 million with adjusted earnings per share now expected to be between $5.50 and $5.70, a 38% increase over last year's adjusted EPS of $4.06. This upward revision reflects robust performance across our three primary revenue streams: royalty revenue, Captisol material sales, and contract revenue. For the full year 2024, we now expect total royalty revenue to be in the range of $105 million to $108 million up from prior guidance of $100 million to $105 million. Captisol material sales between $27 million and $29 million, previously $25 million to $27 million, and contract revenue to come in at $28 million previously $15 million to $25 million. Year-to-date, we recorded total revenue of $124 million and core adjusted EPS of $4.46. We feel confident that we're on track to meet or exceed our updated 2024 financial guidance. We also continue to feel confident about the longer-term outlook with share, which goes out to 2028 and calls for royalty revenue growing at a compound annual growth rate above 20% and adjusted core EPS growing even faster at a compound annual growth rate above 25%. Finally, I'd like to direct listeners to our second-quarter earnings press release issued earlier today, including a reconciliation of GAAP results to adjusted financial results, which is available on our website. Before we open it up for questions, I'd like to remind everyone that we'll be hosting our Annual Investor Day on December 10 in Boston, where we plan to provide you with an update to our financial guidance and long-term outlook.

Our first question from today comes from Matt Hewitt with Craig Hallum.

Hey. Congratulations on a strong quarter, guys. Go ahead. Can you hear me okay?

Hey, Matt. Yes, we can hear you.

Great. Maybe first question is you still have a very strong balance sheet, and I'm just curious what the pipeline looks like. Do the election results this week have any impact on that, on how you think about the market from an investment standpoint? Any update basically on your thoughts regarding adding more shots on goal?

Yes, I think the pipeline remains very robust. There's still very high demand for capital regardless of the election results one way or the other. And the pharmaceutical industry performance in terms of revenue is generally uncorrelated with market volatility even around elections. That's kind of one of the beauties of having royalties in pharmaceutical products is it's non-correlated with capital markets volatility typically. So the demand for capital continues on that, and we continue to look at each asset that's presented to us in the form of a deal opportunity and analyze those the best we can and we're constantly calling that pipeline to pursue what we think are the very best opportunities and that activity is now pretty continuously at a very high level, and I think the business development machine is pretty well-honed here at this point.

Our next question is from the line of Douglas Miehm with RBC Capital Markets. Your line is live.

Thank you. My first question is about the 25 potential investments you are considering. Can you provide some details on their size? Specifically, what is the range you are looking at, and what is the mix of royalties, structured deals, and any acquisitions at this stage?

Okay. That's a great question, Doug. I think that about half of what we're looking at right now is what we call project finance. That's often also called synthetic royalties. That's where you're providing capital to small and mid-cap companies that need capital to develop their assets and in return to that, you're creating a royalty as a form of financing. Those deals are really creative. They're not made; they are not shopped. You proactively are identifying companies and products you're interested in, approaching them, and making those deals happen as an alternative form of capital that's available to them. On the M&A front, we continue to scour opportunities on that front as well. That's a little chunkier. We've got one of those we're looking at now, amongst the many deals we're looking at. And on the passive royalty front, we are actively engaged in academic and venture community as well as the corporate community looking at royalties that are currently held in the form of license agreements by those institutions, and that's probably another third of our pipeline that we're looking at any given time. Oh, yes, excuse me, and the size, Doug, I didn't answer that. But right now at our current size to maintain kind of our diversity limits that we're trying to achieve, we're targeting $30 million to $40 million per product if it's on the development side. If something is significantly lower risk or commercial, for example, we will size up and we view diversification by product, not necessarily investment. So if we're doing a basket of products, those deals may be sized up too. But at our current size, we think kind of $30 million to $40 million per asset is appropriate for us, and that's how we're structuring most of the deals in that range. As we grow over time, we will inevitably kind of size that up a little bit on a proportionate basis.

Great. Okay. The follow-up question has to do with FILSPARI, which is going to be an important backbone of the company going forward. And I was just wondering if you'd be able to talk a little bit about how you see that competitive environment. I know you touched on –

Yes.

Bear with me one second.

Go ahead with your question, sorry.

Yes. I just wanted to expand a little bit on the competitive environment you see for Travere FILSPARI. It seems to be quite attractive, but maybe you could provide a bit more context. Thank you.

Sure. Why don't we have Karen address this, I think, in IgAN as a monotherapy in combination and then, of course, in FSGS where there's currently no other treatment.

Thank you for the question. We believe that FILSPARI will serve as a foundational treatment for IgAN. The recently released draft guidelines emphasize addressing two key aspects of this disease. It will be important for FILSPARI to be recognized as a primary treatment along with other supportive therapies. Recently, Travere presented promising data regarding SGLT-2 inhibitors in a study assessing their combined use with FILSPARI, which demonstrated an increase in proteinuria reduction. This is encouraging news, as the guidelines now recommend lowering proteinuria to less than 0.3 grams per day. Additionally, initial data suggests that using FILSPARI as the primary drug in untreated patients is yielding excellent results. Therefore, we are confident that FILSPARI's role in treating IgAN will continue to expand. Furthermore, we have reported outcomes from the PARASOL initiative concerning FSGS, a significant area of unmet medical need, as there has never been an FDA-approved medication for this condition. Travere plans to meet with the FDA to discuss what is required to submit a New Drug Application, now that the PARASOL initiative has established proteinuria-related endpoints.

Thank you for your questions. Our next question comes from the line of Dr. Joseph Pantginis with Wainwright. Your line is live.

First, a couple of logistical questions, if you don't mind. So, Todd, when you look at obviously the number of opportunities that you're currently looking at, how do we view that with regard to your ability to look at even more? And it really correlates to my question of is Ligand rightsized right now?

I think we're on the same page, Joe. When you ask if we're right-sized, are you referring to our access to capital in relation to our current market cap, or do you have something else in mind?

Inside the employee base and the number of people to look at…

Oh, yeah. Yeah, I think we've made a number of senior hires over the past year and a half as we put this strategy in place. We have this year kind of tweaked that with executives at the Vice President level that come in with significant skill sets to back that up as well and I think we're pretty set on the team and that's kind of one of the things about this business model is that it offers very high operating leverage on the investment side, and we don't really need to add a lot to our team at this point, even if the size of the company grows dramatically over the next 2 to 4 years. So, we're just under 40 employees now. I'd be surprised that we're over 50 employees 3 years from now. That's just the way this business model works, and we like it that way.

That's very helpful. Thanks. And then just a quick logistical question before I ask my usual question is, what is the status, don't think you'd really be doing it right now, but what's the status of your buyback program?

Well-, we just have that in place as a matter of general, I'd say, corporate hygiene. If there are any significant dislocations in the market, they have nothing to do with what we view as the inherent value of our business, we may take advantage of that. We have no immediate plans to use it right now.

No, that's helpful. And then as I alluded to my usual question, focuses on Captisol. It's typical volatility that you alluded to earlier with regard to the timing of payments and customer orders. So I guess the concept I want to look at is the mix here. Obviously, you have growing revenues from Kyprolis, I'm sorry, from Captisol used products. So I guess how should we view the mix right now and view it going forward with regard to, say, research requests versus, say, early clinical study requests?

Yeah. Joe, Todd here. Thanks for the question. It's a similar answer. Nothing has really changed here. It's in the 80/20 rule; we get 80% of our revenue from 20% of our customer base to commercial customers and then a long tail of smaller research clinical use only customers, and that tail we're encouraged by the activity there. We expect that some of those smaller customers will be successful in their development and eventually become some of the join the roster of the larger commercial. But the business is doing well, and like I implied with our updated guidance, it's exceeded our guidance for the year. So the business continues to perform.

Thank you for your question. Our next question is from the line of Dr. Balaji Prasad with Barclays. Your line is live.

Good morning. This is Shao on for Balaji. Thanks for taking our question. And just a follow-up question on FILSPARI. So as Paver is preparing supplemental NDA for FSGS, wondering if FSGS is already factored into the 18% CAGR that's like you highlighted earlier, all the only like the current indication, IgAN is already factored in? Thank you.

Yeah. No, no. This is Tavo. Good question. So when we came out with our long-term outlook at Investor Day last December 23, we had significantly discounted a very small contribution allocated to the pipeline from FSGS. We will update our view here coming up in December 10.

Thank you for your question. Our next question comes from the line of Trevor Allred with Oppenheimer. Your line is live.

Can you guys talk about some of the recent changes with the Agenus royalty assets? Have you had any interactions with them? And do you have any expectations for those royalties going forward?

Yes, regarding the Agenus acquisition, they did have some programs return, and the BMS was somewhat unexpected. For the general audience, there were seven assets in total, with the primary asset related to Agenus being crucial to our investment thesis. We evaluated the six-month data from an ongoing study they are conducting, which appeared promising. In the coming months, we will have access to the twelve-month data, which is our main focus. If that data aligns with the six-month results, I believe we will be in a strong position, and Agenus will also benefit. This is the basis of our considerations concerning the Agenus deal, and we will await the forthcoming data.

Okay. And can you also talk about some of the things that give you confidence on the commercial launch for Pelthos in the first quarter of 2025?

We would be glad to share that Pelthos is a company we established to commercialize ZELSUVMI, which is the first approved take-home treatment for molluscum contagiosum. Historically, the only treatment options have been in-office procedures that tend to be inconvenient and potentially painful. While there are other treatments like cryotherapy and certain formulations of oil that have been around for a while, we are entering the prescription market for take-home medications. We believe there will be significant demand for this product upon its launch, with a conservative estimate of $150 million to $200 million in net sales potential in the U.S. market. We hold global rights to the product and are quite optimistic about its potential. ZELSUVMI is our lead asset from the platform we acquired, and our focus is on its development since it is now FDA-approved. We are in discussions with potential marketing partners for its launch, making this our top priority. Additionally, we remain enthusiastic about the platform overall, as we have clinical data on four other assets for which we will seek partners for further development and commercialization. While nitric oxide is not classified strictly as an antiviral or antibiotic, it exhibits characteristics of both and has promising clinical data for other products. We see the potential to gain royalties from this platform, starting with ZELSUVMI, and believe the long-term outlook for this investment is very positive.

Thank you for your question. Our next call is from John Vandermosten with Zach Small Capital Research. Your line is live.

Great. Thank you, and good morning. So we like to look at M&A to get a sense of where things are going, and I took a quick look at some of the over $1 billion transactions that have taken place, and they've been in neuro cancer and dermatology. Do you look at these at all to get a sense of kind of where the next trend will be in terms of good investments and where products may have a good end market?

We do, but our primary driver, because we're very product-focused, is high unmet clinical need. And so even on the commercial side when we come across commercial products, we're looking at things like QARZIBA and neuroblastoma. We don't specifically have a strategy around certain therapeutic areas, which the market can tend to group around. Market moves around, various therapeutic areas can come in and out of favor. We're very just focused on the products and the high unmet clinical need and whether they're addressing something that's really important clinically to patients. And the reason we're focused on that is, one, I think that's important in general in terms of what we do with our daily lives. But that's your best defense also against payer pressure. And so ultimately, all of these products are going to have to sit down when and if the development is successful and have discussions with payers around reimbursement, and the best-positioned companies are getting drugs approved that make big clinical differences in the lives of patients. And so that's why we're focused on that just as a matter of business strategy, and that just drives us into different corners. Sometimes we'll make contrarian investments. I would say that right now, something like ZELSUVMI, which is a topically applied medication, may be viewed as contrarian because it's more of a specialty pharma product. It's topically applied. I think dermatology is a little out of favor right now. But the reality is, there's very high unmet clinical need. These patients present primarily to pediatricians. They can't really do much for these patients other than refer them to pediatric dermatologists. The waiting list took very long to get in to see those types of physicians. And so we just think that this offers a really key solution in this clinical arena for patients and are confident in it. And so that's kind of how we think about our investing and our choices because in the long term, various therapeutic areas will come in and out of favor. Even if they remain relatively underserved, that just happens as a matter of investing strategies. So that's how we view it if that's helpful.

Okay. Yes. Thanks, Todd. And a couple of questions on Captisol. I think that the company had indicated that there might be some lifecycle management-type of efforts that could take place. And then secondly, what is the competitive environment like for a solubility and instability agent out there? And do you guys control, I guess, I'm just wondering, how much of the market do you have a handle on, there and who are some of the others that might come up? When somebody's looking for an agent like that?

Sure. Yeah. There remains very high demand for solubility-enhancing molecules or excipients that can enhance the solubility of the chemical entities that are active. Solubility and permeability are the two biggest drug delivery issues. Solubility being the third, and Captisol itself has probably the strongest position amongst the solubilizers. There are other ways to do that, obviously with nano crystals and things like that. So there's different technological approaches. So why is Captisol, why does it have 16 approved products historically, that's probably, I don't know because I haven't done the historical analysis. That's probably the most prolific single drug delivery platform in history to have 16 approved products on one. Maybe there's a gel cap technology or something that's similar but in terms of solubilization, that's pretty dominant. And the reason why it's dominant is because it works so well; it works broadly and it's very easy to work with. So our customers can basically get samples from us. Any chemist in the pharmaceutical industry can work with it very easily. If it works on their molecules, they come back to us and they take a license. So we make it easy to work with, and it solves a lot of the solubility problems that our customers face with the chemicals they're trying to formulate. So I hope that helps answer that question.

Thank you for your question. And with that, ladies and gentlemen, that will conclude our Q&A session for today. And to wrap up, I'd like to turn the call back over to Todd.

Thank you. We are confident and optimistic. We believe we have the right strategy, we have the right team, and we are executing with discipline on the right market segment to deliver lasting, predictable, and compounding growth. Thank you all for attending the earnings call today.