LGND - NASDAQ

Thank you for standing by. My name is Kate and I will be your conference operator today. At this time, I would like to welcome everyone to the Ligand First Quarter 2025 Earnings. All lines have been placed on you to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. [Operator Instructions] Thank you. I would now like to turn the call over to Melanie Herman, Executive Director of Investor Relations. Please go ahead.

Good morning, everyone, and welcome to Ligand’s first quarter 2025 earnings call. During the call today, we will review the financial results we released earlier today and provide commentary on our partner pipeline and business development activity, followed by a question-and-answer session. Before we get started, I would like to point out that we will be discussing non-GAAP results, which excludes certain items such as stock-based compensation, amortization of intangible assets, amortization or impairment of financial assets, losses from derivative assets and expenses incurred to incubate the Pelthos business amongst others. I encourage you to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP measures, which can be found in today’s release available on our website. We believe these adjusted measures provide valuable insight into our core operating performance both historically and going forward. 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; Chief Financial Officer, Tavo Espinoza; Rich Baxter, Senior Vice President of Investment Operations; and Vice President of Strategic Planning and Investment Analytics, Lauren Hay. This call is being recorded and the audio portion will be archived in the investor 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 files 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 now turn the call over to Todd.

Thank you, Melanie. Good morning, everyone, and thank you for joining our call. I’m pleased to share that we have had a strong start to 2025, setting the stage for what we believe will be another solid year of growth and execution for Ligand. Over the past 15 months, we have experienced incredible momentum across our royalty portfolio driven by 10 new investments and four FDA approvals. As we have mentioned in previous calls, we believe that Merck’s Capvaxive, Verona’s Ohtuvayre, Travere’s Filspari, Recordati’s Qarziba and Pelthos’

Thank you, Todd. I’m pleased to share an important update on our progress with Pelthos Therapeutics in the

Thank you, Rich. I’m pleased to report a strong start to the year with the first quarter results that position us well to achieve both our 2025 financial guidance and our longer term growth objectives. Let me begin with a few highlights. Total revenue for the quarter was just over $45 million, driven by 44% growth in royalty revenue, which totaled $27.5 million. Adjusted earnings per share came in at $1.33. As Todd mentioned, we continue to maintain a strong financial position. We ended the quarter with $209 million in cash and investments, after deploying $50 million in cash toward our Phase 3 D-Fi asset in partnership with Castle Creek. Including our available credit facility, we have over $400 million in deployable capital. Slide 16 provides a closer look at the numbers. Total revenue for Q1 2025 was $45 million, up from $31 million in the same period last year. That’s a 46% increase. Growth was broad-based across all three revenue lines, but royalties drove the largest contribution. Key drivers of that royalty growth included strong performance from Verona’s Ohtuvayre, Travere’s Filspari, Recordati’s Qarziba and Merck’s Capvaxive. We also saw increased Captisol sales, primarily due to Gilead’s restocking of Veklury, their COVID 19 antiviral. Let me expand briefly on a few of these programs. We’re especially encouraged by Verona’s U.S. launch of Ohtuvayre for COPD. They reported Q1 2025 sales of $71.3 million, almost double their Q4 results. As a reminder, we now earn a 3% royalty on Ohtuvayre following our strategic investment of roughly $20 million over the last year to acquire an additional 1% royalty interest. At our Investor Day last December, we projected that Ohtuvayre would reach $1.2 billion in sales by 2029, implying annual royalty revenue of over $35 million to Ligand. Some analysts now forecast hitting that milestone as early as 2027. Ohtuvayre is shaping up to be a major long-term growth driver for us and we look forward to updating our long-term projections later this year. Turning to Filspari, Travere reported first quarter U.S. sales of $56 million, beating consensus and representing more than 180% year-over-year growth and 13% sequential growth. Ligand earns a 9% royalty on Filspari sales including those generated in Europe via CSL Vifor. We were pleased to see that the EU’s recent full approval of Filspari and we’re closely watching two near-term catalysts, the potential REMs modification within August 28 PDUFA target action date and an FDA update on the sNDA for FSGS, which could receive approval this fall. With a potential expansion into FSGS, Filspari could become our largest royalty generating asset approaching $50 million in annualized royalties by mid-2026. Merck’s Capvaxive also posted strong results reporting $107 million in Q1 sales. That’s more than doubled the prior quarter and well ahead of expectations. We did see some offset from Kyprolis, Amgen reported Q1 sales of $324 million for Kyprolis, down 14% year-over-year, primarily due to competitive pressures. On the Captisol front, we recorded $13.5 million in material sales this quarter compared to $9.2 million in Q1 2024. This growth was driven by timing of shipments and higher demand from Gilead for Veklury. We expect a more even shipment cadence over the remaining quarters. Turning to operating expenses, combined R&D and G&A increased this quarter primarily due to a one-time $44 million charge related to our royalty financing agreement with Castle Creek. This supports the Phase 3 clinical study of D-Fi and is accounted for under ASC 730-20 research and development arrangements. Additional increases reflect headcount growth and continued investments in the Pelthos business. For the quarter, G&A and R&D expenses were $19 million and $50 million respectively compared to $11 million and $6 million in Q1 2024. GAAP net loss for the quarter was $42.5 million or $2.21 per share compared to net income of $86.1 million or $4.75 per diluted share in the prior year. The variance is largely due to the gain we recorded last year from our investment in Viking Therapeutics versus the R& D charge we booked this quarter. On a non-GAAP basis, core adjusted net income for Q1 2025 was $26.6 million or $1.33 per share. That’s up from $21.8 million, or $1.20 per share in Q1 2024, driven primarily by top line growth. Turning to the balance sheet, we ended the quarter with $209 million in cash and short-term investments, including $24 million of Viking stock. We believe this level of liquidity combined with our expected cash flow positions us well to fund our investment plans for the foreseeable future. Finally, we are reaffirming our full year 2025 financial guidance. We continue to expect royalty revenue between $135 million and $140 million. Captisol sales between $35 million and $40 million, contract revenue between $10 million and $20 million, total revenue between $180 million and $200 million, and core adjusted EPS between $6 and $6.25. We are, of course, continuing to monitor legislative and geopolitical developments. Based on what we know today, if tariffs were to be expanded more broadly into pharmaceutical products, we do not expect a material impact to our Captisol business or to Ligand more broadly. That concludes my remarks. I’ll now turn the call back to Todd for closing comments.

Thank you, Tavo. To sum up, we’re off to a great start in 2025 and we’re excited about the trajectory of the recently approved programs as well as our robust development stage pipeline. Additionally, our investment capabilities offer us the ability to materially grow our asset portfolio. Our diversified portfolio including our major commercial royalty generating programs and the late-stage pipeline form the foundation of our growing success. On its own, the commercial portfolio should drive growth in the mid-teens through the early 2030s. When you add in our development stage portfolio including but not limited to Palvella’s Qtorin MLM asset, Travere’s FSGS sNDA submission and our recent investment in D-Fi with Castle Creek, we continue to expect EPS growth of over 20%. Through investing, we will continue to add to our commercial and late-stage clinical assets as this portfolio provides us with substantial cash flow to reinvest in new high value enhancing royalty opportunities. We are well positioned to execute against our goals in 2025 and deliver attractive growth and shareholder returns over the long-term. Thank you everyone for joining us for today’s earnings call. I will now pass it back to the operator and open it up for questions.

[Operator Instructions] Your first question comes from the line of Doug Miehm with RBC Capital Markets. Your line is open.

Thanks very much. My question has to do with the – you touched on this, the current environment for the space and one might also – almost say that you have an embarrassment of riches here in terms of identifying and potentially bringing in royalties to project financing or special situations. Would you say that you’re seeing even more special situations these days? And if so, what the implications for the company may be? Thank you.

Thanks, Doug. That’s a good question. There is an increasing number of special situations. Much of that is driven by difficult financing markets for biotech companies. And I think the implications for this or – for these companies and the industry in general is recaps, mergers, the sale of some of these companies. And it provides a good opportunity set for us too. I mean, a key core thesis of our strategy is that and this was part of the whole Novan and

Excellent, thank you.

Your next question comes from the line of Matt Hewitt with Craig-Hallum. Your line is open.

Good morning and congratulations on the strong start to the year. Maybe first up, there’s news that’s broken here over the last 24 hours. I realize it’s pretty recent. But with the potential for most favored nation’s status for drug pricing, it sounds like it would just be – this is uncertain Medicaid or Medicare. But are you – what do you think that that would do to how your partners kind of look at where they launch, when they launch, those types of things? What would be the potential impact from that, if any?

Yes. That’s a great question, Matt. And although, this news just broke this morning. There has been, I think, dislocation in the pricing markets based on different policies across the globe. And for a couple decades at least, if not more, the U.S. has paid premiums for medicines compared to other countries. And as you know, this administration is also very focused on fair trade. And they also have a reputation for starting out with really big asks and then trying to get to some deal making resolution of some sort. So I expect that that’s the direction that this announcement will go as well. And ultimately though, I think that the U.S. is the main market. Most of the partners we are partnered with, not all because Qarziba is launched in Europe, obviously, and across the globe really, but not in the U.S. but most of our partners are focused first on the U.S. market and then follow on in the other markets. But I think in terms of expectations, there’s going to be a period of significant short-term disruption as this is sorted out and trade policies around pharmaceuticals are negotiated. But long-term, I think it’s probably a good thing.

That’s helpful. And then maybe as a follow-up question, given – and you noted this at a couple different times in the prepared remarks even, but given some of the disruption that we’re seeing and the challenges that – potential partners are having on the funding side. As you look at your investment opportunities, has the sizing changed at all or are you still kind of looking kind of as – those bite size $10 million, $20 million type investments and spreading your strong balance sheet over multiple shots on goal or would you consider something larger? Thank you.

Thanks, Matt. I think for the general audience here, I would just say that, we’re trying to create a very diversified portfolio. And so the general guidance that we’re following now at our current market cap and our current portfolio size is that we believe that $50 million is about the most we want to invest in a binary risk situation. And so that’s about the most we’re going to do in a binary situation. That was the size of our investment at Castle Creek. We syndicated in the other $25 million for that reason. And that’s just a portfolio math. We’re trying to create a diversified portfolio, not everything will work. And we think that the math really works well at that size. Where we will upsize is in significantly derisk situation and the best recent example we have of that is Apeiron that was already a launched product that had been on the market in Europe and the rest of world for over three years had significantly entrenched become significantly entrenched in clinical practice. And the clinical safety and efficacy profile was very well known in a broad population with very high clinical need. So really about as derisk as you can get, by the way, the marketer here is very good Recordati. So we felt really good about that. That was a $100 million deal. And so we will upsize on really derisked situations that do not have binary risk. And then long-term, as our portfolio grows proportionately, we will move up our diversification limits consistent with our view on the portfolio math.

That’s very helpful, thank you.

Your next question comes from the line of Trevor Allred with Oppenheimer. Your line is open.

Hey, good morning guys. Just had a couple quick questions. Is there anything you can say on Qarziba expectations? Any of the activities Recordati is doing there to expand use? And can you also talk to where these blossom continue? Some patients are most primarily seen, is it pediatric derms or is it pediatricians or what’s the, I guess, referral patterns that might happen there?Thanks.

Thank you, Trevor. I’m going to ask Lauren Hay, who’s on the call with us to address the first question regarding Qarziba, as she’s tracking that from a portfolio management perspective. And then I’ll have Rich Baxter answer your question on Molluscum contagiosum. Lauren?

Sure. Thanks for the question. So, as you may be aware, Recordati has recently started disclosing Qarziba sales in their three-year projection presentation a couple weeks ago. That showed impressive growth of 23% between 2023 and 2024. And then they also increased the peak sales guidance for the oncology franchise. They bumped that up from €250 million to €300 million to €300 million to €350 million. They’re continuing to invest in geographic expansion which is driving that upsize peak year estimate. They launched in South Korea last year. Latin American launches expected this year. And then as you’re probably aware, they are continuing to pursue approval in the U.S. and the next planned FDA interaction on that front is mid-year. So we’ll be looking forward to an update there. Those are some of the shorter-term growth drivers. And then in terms of medium to longer-term, they’re investing in expanding the use of Qarziba to induction therapy both in frontline and in the relapsed/refractory setting. And then the longer-term, they’ve recently announced a program to expand the use of Qarziba to Ewing sarcoma patients, which would, if approved, provide pretty dramatic revenue upside in the longer-term. So I think we continue to be very optimistic about Qarziba and Recordati’s commercial success with this product. I’ll turn it to Rich for your second question.

Thanks, Lauren. Molluscum contagiosum is primarily seen initially by pediatricians. As the condition worsens, these – they get referred to pediatric dermatologists for children and dermatologists for adults. So initially the target market is going to the sweet spot of the target market are pediatric dermatologists and dermatologists and pediatricians will be critical for the product going forward.

Great. Thanks.

Your next question comes from the line of Annabel Samimy with Stifel. Your line is open.

My question – congratulations on a good quarter. Just following on the biopharma environment and the number of opportunities that you have. I appreciate your desire to remain relatively diversified. Any thoughts as to the investment capacity you’re willing to put out every year? I think you talked about 150 to 200 in total capital allocations for the year. Any thought to increasing that and taking advantage of the environment? So that’s the first question and the second is regarding NITRICIL. Now that you have Pelthos often

Sure. Thanks, Annabel. Sure. On investment capacity, I think there’s probably a pretty good chance we invest at above our normal pace this year just given the environment. The number of good opportunities we’re seeing, as was mentioned in the earnings call, about half of what we’re looking at is currently commercial but still is offering significant returns above what we would consider normal market returns. So those we are interested in as well and that could result in a higher deployment level. That said, we’re going to observe our diversification limits on the deal size and it takes just as much work to do a $5 million deal as it does a $75 million deal and get it right. So we have certain bandwidth restrictions as does any investment team. And we’re going to go at the pace that we’re capable of. But everybody here is working pretty hard given the opportunity set right now. So that’s what I’d expect on the investment pace. And in terms of the NITRICIL platform, that’s a great question. I think that I would just comment that this is a special situation. Sometimes the special situations require more work and therefore consumes more bandwidth. And therefore there can be more opportunity costs with them. And that’s the case with Novan. So the reason that you do that is because of potential outsized returns. And on the single lead asset

Great. Thank you.

Your next question comes from the line of John Vandermosten with

Great. Thank you. And another question on Pelthos. Is the initial launch time for

It’s fairly independent at this point, but I think the Venn diagram overlaps pretty nicely there. We’re expecting, as Rich said, to close – the merger to close at least the two standard deviation normal ranges between June 30 and August 30. And we already have the skeleton of the team. We even have some regional sales managers in place. They’re all preparing for the launch. The manufacturing team has been in place and is manufacturing commercial supplies. So the next step will be to hire sales reps. We’re going to have significant feedback from the SEC in the next two to three weeks, I think after our initial submission, that’s going to tell us a lot about the length of the pathway and we’ll probably dial-in a little bit, our rate of hiring on the sales reps as we get that information. So that’s the plan currently, John I think the financing is secured, the merger target along with the required number of votes is secured. So really, for the most part, this is a matter of timing, which we don’t totally control with the SEC.

Okay. And then looking at Filspari, you had mentioned that it had shifted from conditional marketing approval to standard of marketing approval in Europe. And does that change any reimbursement or access for the product?

I’ll let Lauren Hay comment on that.

Yes, I think, John, it’s a great question. I think we’re expecting to see kind of continued momentum from Travere’s partner CSL Vifor. I think probably doesn’t dramatically change the trajectory. They’re continuing to secure country by country reimbursement approvals and further invest in the launch. So we’ll continue to see, I think, growth in the coming quarters from them. And certainly an encouraging development for CSL Vifor and Travere as well.

Okay. And last one for Tavo on revenue trends for the year. Should we expect to see something similar to last year where a little bit lower in the first quarter and then a jump in the second quarter and kind of slowly trend up. And I know contract revenue played somewhat of a role there, but ignoring that line, how do we think it’s going to, I guess that cadence, so to speak, of revenues for this year – for the rest of this year?

Yes, pretty – thanks, John. Yes, pretty balanced cadence on the Captisol. You – I mean, you see that we’re reiterating guidance. So you can do the math pretty straight line from here on to the end of the year on Captisol and then just given the nature of some of the royalty arrangements with the tiered royalty rates with Kyprolis and a couple of the others, you should expect to see kind of a gradual uptrend as is typical on the royalty line.

Great. Thank you.