Good evening. My name is Rob and I will be your conference operator today. At this time, I would like to welcome everyone to the Ligand Pharmaceuticals Fourth Quarter 2022 Earnings Webcast. [Operator Instructions] Thank you. Simon Latimer, Head of Investor Relations, you may begin your conference.

Thanks, Rob. Welcome to Ligand's fourth quarter 2022 financial results and business update conference call. Speaking today for Ligand will be Todd Davis, CEO; Tavo Espinoza, CFO; and Matt Korenberg, President and COO. We will use non-GAAP financial measures, and some of our statements will be forward-looking, including those related to our financial condition, results of operations, financial guidance and the impact of the COVID-19 pandemic. Additional information concerning risk factors and other matters concerning Ligand can be found in our earnings press release and our periodic filings with the SEC. We undertake no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. A reconciliation between the non-GAAP financial measures we discuss and the closest GAAP financial measure can be found in our earnings release issued earlier today. I'd now like to turn the call over to Todd Davis.

Thank you, Simon, and good afternoon everyone, and thanks for joining our fourth quarter 2022 earnings call. For those who didn't get a chance to listen to our recent Analyst Day event in December, or meet at the JPMorgan Conference, I am Todd Davis, the CEO of Ligand. I'm delighted to have the opportunity to address you all today and share some of my thoughts on the company's performance and our future prospects. Now, I have been on the Board for many years, over the past 2 months, I've been getting up to speed on the internal workings of the company, and meeting with the team working with the Board of Directors and spending time with a number of our shareholders. I'm confident that the future of Ligand is a bright one. Our initial and primary goal for the company is to maintain a laser like focus on financial performance. To that end, in 2022, we've had a strong finish to the year. Key components to highlight. Royalty revenue grew by nearly 50% to $72.5 million, compared to $48.9 million in 2021. Profitability in 2022 of $2.44 in adjusted diluted EPS from our core continuing operations, compared to $2.35 in adjusted diluted EPS in 2021, including sales of Captisol for COVID, the adjusted diluted EPS of $4.79 in 2022. Our balance sheet ended the year with over $200 million of cash and liquid investments. We successfully completed the spin out of OmniAb, enabling Ligand to refocus on its core strengths and original value proposition. And last week's approval of Sparsentan in partnership with Travere Therapeutics adds to our royalty generating asset portfolio and positions us for strong continued growth. Tavo, our CFO will provide more 2022 financial results, as well as our increased '23 financial guidance. The following framework may…

Thanks, Todd. The fourth quarter of 2022 was not only transformative literally, but also very strong financially, with continued impressive royalty revenue growth. My review will reflect Ligand's financial results on a continuing operations basis, now that OmniAb -- now that the OmniAb spin out is complete. Total revenues from continuing operations for the quarter were $50.4 million. Royalty revenue increased 25% to $22 million from $17.6 million a year ago. This growth was driven by strength in Amgen's KYPROLIS, which once again reported record quarterly net sales, as well as contributions from Merck's VAXNEUVANCE and Jazz Pharmaceuticals' Rylaze, and they both exceeded our expectations. Related to Captisol, investors are all familiar with this topic by now. But starting in 2020, with the onset of the pandemic, we dramatically increased our Captisol sales related to COVID. Over the past 3 years, we sold more than 300 million of Captisol for COVID, with the peak year being 2021. In 2022, we sold about 88 million of Captisol for COVID, down from about 141 million in 2021. These sales are an excellent source of cash for Ligand, but are not indicative of the performance of the core Ligand business. So far, we have not received any Captisol for COVID orders this year. Total Captisol sales were 26.9 million for the quarter versus 35.4 million a year ago. Core Captisol sales were 3.3 million this quarter versus 7.1 million last year, with the difference due to timing of customer orders. Captisol sales related to COVID-19 were 23.5 million during the quarter compared to 28.3 million a year ago. Contract revenue in Q4 2022 was 1.5 million. This compares to last year's fourth quarter of 3.5 million. This difference in contract revenue is generally due to timing of partner events and related milestone payments.…

Thanks, Tavo. 2022 was a year of significant change for Ligand with strong underlying business performance through it all. Financially, we exceeded our expectations for our core business and sold significantly more Captisol for COVID than we expected. Operationally, we successfully completed the spin-off of our OmniAb antibody discovery platform and strategically, our partners posted continued strong sales growth with commercial programs, while clinical stage assets made excellent progress, including positive results for many key programs. Obviously, the biggest news of note recently with the Sparsentan approval late last week. Our partner Travere received approval for Sparsentan in IgA nephropathy. Travere will market Sparsentan as the brand name FILSPARI when they launched the drug next week. Sparsentan is a key pipeline asset for Ligand. We will earn a 9% royalty on sales, and we expect that this will be a significant driver of long-term growth for our royalties. Travere expects a decision from the EMA for the conditional marketing authorization for Sparsentan for IgA nephropathy in Europe in the second half of 2023. IgA nephropathy affects an estimated 150,000 patients in the U.S. and a similar number in Europe. Approximately 30,000 to 50,000 of the U.S. patients are expected to be addressable under the indication approved via the accelerated approval. Sparsentan is the first non-immunosuppressive treatment approved for this indication. In our view, the initial label is consistent with the expectations going into the PDUFA date and does not change the outlook for the drug in the short-term or the long-term. Consensus sell-side estimates for Sparsentan show peak sales exceeding $1 billion, which, if achieved, would make Sparsentan Ligand's most significant royalty by a factor of 2. For 2023, Travere pointed to the existing consensus estimates from the research community, which currently range from about $10 million to $45 million…

[Operator Instructions] And your first question comes from the line of Joe Pages from HC Wainwright. Your line is open.

Hey, guys. Good afternoon. Thanks for taking the question and thanks for all the updates. So I have two things I want to focus on. So first, Todd, you talked about making the company leaner and Tavo, you talked about R&D line reductions. So I'm curious, since you've taken over, where do you feel you stand in the continuum of not necessarily cutting costs, but optimizing Ligand's P&L and personnel?

Yes. I think there will be -- we are reviewing that, Joe, continuously. We are looking at things that contribute directly to our mid to near-term financial profile, that's our emphasis. And so that constantly requires scrutiny. I can't share any specific plans right now, but we'll continue to focus on expense management, very carefully. As you can see in Tavo's comments, we've already made some strides in that arena.

Got it. No, that's helpful. Thanks. And then the second question is, I guess, with regard to the Captisol franchise, I guess, two parts: a, your overall commitment to the program, excluding for remdesivir purposes and also getting a sense of what the mix -- how the mix has been evolving as of late with regard to, say, inbound research requests versus growing commercial use?

Yes. Thanks, Joe. Yes. So on Captisol, first off, we are very committed to the platform and the technology. It's been a key component of Ligand for 12 years now, and we see it as a key component going forward for a long time. You asked a bit about the Captisol platform and its use for remdesivir, obviously, we are reporting our earnings separate from that and excluding the Captisol COVID-related sales and earnings from our adjusted numbers and guidance. But we are still prepared to deliver on that. As folks remember, we made a significant capital investment in 2020. And that -- all that equipment and the capacity that we created for that has been put in place and still, generally speaking, exists. A lot of the key components that were needed to be able to address real-time demand, if any sort of wave of pandemic or need for Captisol came up, are still in place. And then similarly, the rest of the franchise, the other 70 to 100 customers that order Captisol every year, the improvements benefit them as well through faster turnover times and more efficient manufacturing. And so all of that still is in place, and we are still really excited about the business.

Perfect. Appreciate all the comments guys. Looking forward to an exciting 2023.

Thanks, Joe.

Your next question comes from the line of Larry Solow from CJS Securities. Your line is open.

Great. Congrats on a really nice year. 40% royalty growth or high 40s. It's very impressive. On the royalty line itself for '23 and the outlook, kind of flat, basically, right, if you add back whatever a couple of $2 million, $3million you get for Sparsentan, if it kind of comes down the middle of at least analyst estimates. So is -- and you had -- Captisol had a good year in '22, right, 14% growth. And obviously, your Pelican a lot of those numbers are Teriparatide and Rylaze are [indiscernible] years. So are one of those backing off a little bit? What's sort of the reasons for a flattish outlook in '23?

Yes. Thanks, Larry. I think a couple of things are contributing to what you're commenting on. First off, Q4 ended incredibly strong for a couple of products that make the comp, if you will, year-over-year look a lot more muted than it might have compared to, say, our original guidance when we give it a month or 3 months ago or so. But second, the one product that our guidance incorporates right now that probably fits the description of what you're looking for is teriparatide. Teriparatide had a real nice year in 2022. As we mentioned last year, midyear was sort of when we expected competition for that. As investors know, currently, our Alvogen's version of teriparatide that was created under the Pelican expression technology is the only alternative to Eli Lilly's Forteo that's on the market. There are two other competitors that have pending ANDAs or similar filings for their versions of teriparatide -- they've both been on file for a very long time at FDA. But at any moment, we could see competition emerge from those folks and the dynamics in the market could change. There are several ways that, that could play out, obviously. One or any one of us could get a therapeutically equivalent rating or TE rating as we've been calling it, which we create one drug being the sort of preferred generic versus the others or all three of us could be on equal playing field or only one of the other competitors could get improved or none could. I think it's fair to say that if none get approved, we'd expect some upside to our royalty expectations for teriparatide but if competition does emerge and depending on how it emerges that may change our royalty expectations, both up or within our range, staying within our range or going on.

And then can you just maybe give one more flavor, just a little more color just on what the teriparatide royalties were this year or ballpark on what they were and sort of what you think -- what the assumption you're making in '23?

Yes, sure. You'll see in the K when we file next week. But the first 3 months of the year were about $12 million of teriparatide royalty -- and then there was another 3 or so a little bit more than that, that we booked this quarter. So we end up just over 15% in terms of royalty for teriparatide this year. We're assuming a relatively flat, maybe even a little bit of a decline next year. Sort of annualizing the Q4 number around 3.5% or so.

Okay. All right. Okay. All right. I appreciate the color. And just one -- quickly just on FILSPARI or Sparsentan. Maybe Travere is the one to answer this question. But just in terms of the box warning, some of the restrictions and you mentioned, you alluded to, you kind of mentioned, I guess, more confirmatory data and [indiscernible] progression hopefully shown in the data that comes out in Q4. But with the potential change in the label, would that also include sort of modification on this box warning? Or is that something that might be there for a little while longer? And is that a -- I feel like that was expected, but is that a hindrance I guess that will be a view of the hindrance for sales initially, I'm sure, to some extent, maybe you can -- any commentary on that would be great. Thanks.

Yes. Thanks. Yes. So as folks know, there -- the approval with first Sparsentan or FILSPARI came with a REMS program and monitoring requirements. The label called for monthly monitoring of liver enzymes and for the first12 months and then quarterly monitoring thereafter. The label also included a target of certain creatinine levels that was $1.5 million versus some of the trial data and others that was run closer to 1. The expectation, as you say, we don't have any insight that's not publicly disclosed, first off, just so all investors are [indiscernible]. But just basing on the comments from Travere on their call and reading some of the label data and others, it seems that there's a likelihood that the creatine levels are adjusted post the full data readout. And then as over time, the safety as seen on monthly monitoring that the full-time or the long-term monitoring could be permanently reduced or shortened. What that generally means to us, though, is that all of that was largely expected for the accelerated approval. And that as we've -- as Tavo's addressed, and we've said before, we don't have significant expectations for Sparsentan in the first year. It's just a couple of million adding into our royalty line, even though they're planning to launch next week when we were originally factoring in a launch in Q3. But we'll just have to see how the market develops over time with both the data as it reports out and then the safety monitoring on the REMS program.

Got it. Thanks, Matt. I appreciate it.

Thanks, Larry.

[Operator Instructions]. Your next question comes from the line of Matt Hewitt from Craig-Hallum Capital Group. Your line is open.

Good afternoon. Thank you for taking the questions. Maybe the first one up on Sparsentan. With a potential EMA approval, would that trigger another milestone?

Yes. Thanks, Matt. Yes, there is another milestone. [Indiscernible] it's almost $1 million, yes. [indiscernible] I'm sorry, I missed that.

Sorry, it's -- I think $2.7 million, right around there.

Got it. Okay, great. And then as we look at the Captisol gross margin. Obviously, utilization of that capacity is a key driver. But are there any other steps that you could take to either help boost that gross margin or maybe contract out some of that capacity? Anything that could raise that number?

Yes. Good question, Matt. So as folks are thinking about our Captisol gross margins, they're probably thinking back to a few years ago, pre-pandemic when our margins on Captisol were more in the 70s type range. A couple of things have happened since then that impact the margins. The one that is probably most relevant is the expansion we made that I referenced, those costs are being amortized through the inventory that we create using the new machines and new process. And so while margins appear lower, it's actually -- some of it is non-cash, meaning we spent the cash back in 2020, and we're spreading the expense of that tied to the inventory that flows through the P&L as we sell it through. So from a cash standpoint, margins are higher in that mid 60s that we were talking about. The other thing is mix shift year-to-year is definitely something that changes. We've said in the past that some of our margins on Captisol are very low and some are high, depends on both whether the product that the partner is buying, we make various versions of Captisol. Also, the use, whether they're buying it for research purposes or commercial purposes or clinical purposes. So margins bounce around for all those things. We are in a period right now where some of the lower-margin Captisol is higher volume than some of the higher margin Captisol. So those two things, the non-cash portion and the mix are what's kind of keeping it at that mid-60s level for now.

Got it. And then maybe one last question regarding the optimization of head count or employees. Do you risk --I'm just trying to think of this on the fly, but as you look to optimize the people around the organization, is there any risk that you get a couple of approvals or you get a couple of partnered programs that progressed maybe faster than anticipated, you're almost kind of behind the gun as far as having the people that you need to manage the organization? Or do you feel like you've got the right number of people and you're kind of looking out 6, 12 months and making sure that you're always kind of staying ahead of the game. Thanks.

Yes, it's the latter. I think we are, I think, very focused on what we need, being able to execute with the partners on the technology platforms. And it's just about being as lean and mean as possible and make sure that we have what we need and no more. So we are being pretty careful about that and trying to draw all the lines in the right places.

Understood. Thank you.

And this concludes our question-and-answer session. I will turn the call back over to Mr. Todd Davis for some final closing remarks.

Thank you, everyone, for tuning into Ligand's fourth quarter earnings call. We will be attending investor conferences in the coming weeks, including the ROTH Conference in Dana Point and Barclays in Miami. We hope to meet you in person at these events. Thanks again, and have a nice afternoon.

This concludes today's conference call. Thank you for your participation. You may now disconnect.