NASDAQ:LGND Ligand Pharmaceuticals Q4 2023 Earnings Report $104.62 -2.18 (-2.04%) As of 04:00 PM Eastern Earnings HistoryForecast Ligand Pharmaceuticals EPS ResultsActual EPS$0.79Consensus EPS $0.24Beat/MissBeat by +$0.55One Year Ago EPSN/ALigand Pharmaceuticals Revenue ResultsActual Revenue$28.10 millionExpected Revenue$24.54 millionBeat/MissBeat by +$3.56 millionYoY Revenue GrowthN/ALigand Pharmaceuticals Announcement DetailsQuarterQ4 2023Date2/27/2024TimeN/AConference Call DateTuesday, February 27, 2024Conference Call Time8:30AM ETUpcoming EarningsLigand Pharmaceuticals' Q1 2025 earnings is scheduled for Tuesday, May 6, 2025, with a conference call scheduled at 4:30 PM ET. Check back for transcripts, audio, and key financial metrics as they become available.Q1 2025 Earnings ReportConference Call ResourcesConference Call AudioConference Call TranscriptPress Release (8-K)Annual Report (10-K)Earnings HistoryCompany ProfilePowered by Ligand Pharmaceuticals Q4 2023 Earnings Call TranscriptProvided by QuartrFebruary 27, 2024 ShareLink copied to clipboard.There are 6 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Welcome everyone to the Ligand Fourth Quarter 2023 Earnings Webcast. At this time, 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. Operator00:00:22I will now hand the call over to Tavo Espinosa, Chief Financial Officer. You may begin your conference. Speaker 100:00:30Hello, everyone, and welcome to our earnings call for the Q4 and year end 2023. During the call today, we will review the financial results we released prior to today's market open and offer commentary on our partner pipeline and business development activity, after which we will host a question and answer session. Our earnings release can be found in the Investor Relations section of our website at ligand.com. Participating for Ligand today will be our CEO, Todd Davis our COO, Matt Kornberg and myself, Tava Espinosa, CFO. This call is being recorded and the audio portion will be archived in the Investors section of our website. Speaker 100:01:05It is our intent that all forward looking statements regarding our financial results and commercial activity made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward looking statements are based upon current available information and 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 has filed with the Securities and Exchange Commission, including our most recent Forms 10 Q and 10 ks. Speaker 100:01:46With that, I will now turn the call over to Todd. Speaker 200:01:49Thank you, Thabo, and welcome to everyone on the call. The end of 2023 marks the completion of my first full year as CEO of Ligand. And I'm happy to say that in the last year, we've successfully transformed the company to take Ligand to the next stage of growth. Slide 3 summarizes our financial and portfolio achievements in 2023, which underscores our strong momentum and the strength of our business model. 1st, we delivered strong financial performance. Speaker 200:02:21We grew revenue by more than 20% when you exclude last year's COVID related Captisol sales, while reducing 2023 cash operating expenses from above $90,000,000 per year to below $40,000,000 per year. This resulted in core adjusted diluted earnings per share of $4.06 which is 66% above the prior year. 2nd, we streamlined and improved the financial profile of the business through restructuring efforts. In addition to spinning out the OmniAb business, we also divested our Pelican protein expression platform via Equity Merger or Spinout to form Primrose Bio. Both of these businesses are valuable technology platforms, but they required additional investment in infrastructure that was inconsistent with our core financial strategy. Speaker 200:03:17This enabled a headcount reduction from over 170 to 35 employees. This operational streamlining was completed even while adding significant talent in the investment, portfolio management and diligence functions to create a premier investment team. Accordingly, that team began to execute on our newly refined strategy in the second half of twenty twenty three. 3rd, we strengthened our royalty portfolio by adding several innovative and exciting new programs, including Sanofi's TZIELD and Takeda's saticlostat. We also expanded existing partnerships acquiring full rights to the recently approved ZILSUVME and expanding a royalty investment in Palvella's PTX-twenty two program, which is in development for microcystic lymphatic malformations. Speaker 200:04:134th, as shown on Slide 4, at our Investor Day in December, we announced for the first time a longer term outlook where we see royalty revenue CAGR of over 20% and an adjusted EPS CAGR exceeding 25% over the next 5 years. The breadth of our asset portfolio provides us with a lower volatility and much greater predictability than is typical in biotech businesses, which in turn provides us the confidence to share these longer term projections. The forecast is driven by our current major commercial programs, our existing pipeline and the expected contribution from the new business development efforts. Tago will cover our financials in a little more detail, but I'd like to highlight that the increase in Viking Therapeutics stock price in 2023 has bolstered our balance sheet as we generated approximately $80,000,000 in proceeds from the sale of Viking shares and still hold approximately 1,700,000 shares. We are reinvesting these proceeds into new investments that will drive additional growth and value creation in the future. Speaker 200:05:29Also, there are several exciting developments across our partnered commercial portfolio and clinical pipeline. During late 2023 early 2024 and there is an opportunity for further value creation through additional important catalysts expected this year. On January 5, 2024, the FDA approved zelsoopnee as a first in class medication for the treatment of molluscum contagiosum in adults and pediatric patients 1 year of age or older. Dilsudmi is the 1st and only prescription medication that can be applied by patients, parents or caregivers at home outside of the physician's office to treat this highly contagious infection. You may recall that we own 100 percent of Zilsupmy rights after funding Novan through a restructuring process and acquiring a significant portion of their assets in 2023. Speaker 200:06:26Additionally, we have 2 partnered products that have PDUFA dates scheduled during June of 2024, Verona's ensifentrine and Merck's V116. Ensifentrine, if approved, is expected to be the 1st novel mechanism available for the maintenance treatment of COPD in more than 10 years. Additionally, the FDA accepted for priority review Merck's new BLA for V114 an investigational 21 valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumonia in adults. Our royalty rates on ensifentrine and D116 are in the low single digit royalty range. Finally, Trevir announced that it received 4 59 new patient start forms for Valspari in the Q4 of 2023 and announced net product sales of approximately $15,000,000 for the Q4, which is an increase of over 80% from the prior quarter. Speaker 200:07:31We have a 9% royalty on TILSPARI and consensus estimates continue to show $500,000,000 to $1,000,000,000 in peak TILSPARI sales. Shortly, Matt will provide more detail around these and other programs. Now let's turn to our business development efforts. In 2023, one of our key priorities was assembling a strong and experienced investment team to execute on our strategy and we are pleased with our progress in this regard. Additionally, I can share today that we've recently added Rich Baxter and Doctor. Speaker 200:08:06Karen Reeves to the team. Rich joins us as SVP of Investment Operations and a member of the Investment Committee. Rich brings significant commercial pharmaceutical industry experience and private equity investment experience. He co founded the healthcare group for Drawbridge Special Opportunities Fund at Fortress Investment Group, which invested approximately $1,000,000,000 in emerging life science companies. He also served as Co Head of the Healthcare team at Hayfin Capital Management, which deployed $1,400,000,000 in capital over 4 years. Speaker 200:08:43Karen is a Board certified position and joins us as SVP of Clinical Strategy and Investments. She brings more than 20 years of experience in senior roles at top pharmaceutical companies with extensive experience in successful Phase 1 to Phase 4 drug development across multiple therapeutic areas. Most recently, she served as President and Chief Medical Officer of AZ Therapies, a private late stage clinical biopharmaceutical company focused on neurology. Prior to AZ Therapies, Karen held multiple leadership positions at Pfizer including VP Worldwide R and D, VP Worldwide Safety and Regulatory and Head of Global Clinical Submissions for Quality. We welcome both Karen and Rich to the Ligand team. Speaker 200:09:36Paul Hadden has been leading our investment origination efforts and was instrumental in increasing our available opportunity set during 2023. Last year, we reviewed over 300 investment opportunities, signed 45 CDAs and closed 5 transactions. We entered 2024 with 130,000,000 dollars in cash, plus we expect to generate approximately $80,000,000 in cash from operations this year. Adding to this is our ownership in Viking Therapeutics stock and a $75,000,000 revolving credit facility. With this strong financial position, we feel we are well positioned to have another successful year led by investment activity, providing exciting growth opportunities for Ligand. Speaker 200:10:28As we discussed in December, the team has built a robust pipeline of investment opportunities that span both significant breadth of therapeutic area, but also diversified transaction types. We are in active dialogue with multiple counterparties and are constantly looking for new exciting opportunities in which to invest capital. The team is currently reviewing approximately $400,000,000 in investment opportunities across multiple strategies including royalty monetization, project finance, M and A and special opportunities. As a reminder about our investment criteria, we are primarily focused on assets that are within a few years of approval in either Phase II or Phase III, are highly differentiated, offer significant value to patients, provide favorable market exclusivity and have above average probability of technical and regulatory success. Ultimately, the number and size of investments we make will depend on the quality of the opportunities we identify. Speaker 200:11:33We believe that we have the right team to execute and excel in this high margin agrowth strategy. It's important to note that the majority of our diligence assessment is done under confidentiality agreements, which provides us advantageous insight into our investment decisions. In summary, 2023 was an important year for Ligand in terms of our financial performance, strategic evolution, investment activity and team building efforts. With these accomplishments, we're looking forward to a busy and productive 2024. Now Matt will cover the portfolio highlights. Speaker 300:12:09Thanks, Todd. 2023 was a transformative year for Ligand. Today, I'll provide investors with an update on key developments from our partners across our commercial programs and our development portfolio. Ligand's portfolio includes more than 85 partnered programs that drive our royalty revenue, our Captisol material sales and our license milestone and contract revenue. Slide 10 shows our key commercial programs that drive the significant majority of our royalty revenue. Speaker 300:12:38Our current commercial portfolio includes over 25 different royalty streams and 30 commercial drivers overall. These 8 programs are expected to contribute over 95% of the royalty revenue in 2024. The team at Ligand is focused on adding additional names to this list. Many of those additions will come organically from our existing partnered pipeline portfolio and some will come through new investments generated out of our now established deal team as Todd mentioned. A few highlights from 2023. Speaker 300:13:07PYPROLIS, which is an important drug for multiple myeloma, continued its strong performance with another solid quarter in Q4. PYPROLIS is marketed by Amgen in a majority of the countries around the world as well as by Ono in Japan and by Beijing in China. Q4 2023, these companies reported combined quarterly revenue of over 370,000,000 dollars Year over year growth for the product was driven principally by volume growth with 2023 reported sales exceeding $1,400,000,000 globally. We earn a tiered royalty of 1.5% to 3% on global sales and expect continued growth in 2024. Our partner Travir is marketing Filspari in the U. Speaker 300:13:45S. In IgA nephropathy. Travir reported revenue of $14,700,000 for Q4. Trevir also continued to disclose the momentum on new patient recruitment. Trevir had 4 59 new patient forms submitted in Q4, bringing the total since launch to 1452. Speaker 300:14:04The continued addition of potential new patients provides good evidence of future revenue potential that supports the consensus estimates for 2024 to return approximately $110,000,000 of revenue for the year. On the regulatory front, Premier announced that the EMA CHMP has recommended approval for sparsantan for the treatment of adults with primary IgA nephropathy. The company expects the EU approval decision in Q2 2024 and the full U. S. Approval decision in Q3 2024. Speaker 300:14:36We earned a 9% royalty on net sales and we expect that this will be a significant driver of our long term growth for our royalties. Rylase is marketed by our partner Jazz Pharmaceuticals as a component of a multi agent chemotherapeutic regimen for treatment of children and adults with ALL or LBO. This product continues to do extremely well in a market that was previously constrained by supply issues. At JPMorgan earlier this year, Jazz highlighted Rylase as one of its 3 key growth drivers. Having received approval for Rylase in Europe in September 2023, Jazz confirmed the 1st European country launch occurred before the end of last year and that additional European launches will continue on a rolling basis in 2024. Speaker 300:15:19In Q3 of 2023, Rylase generated $104,900,000 in sales. We look forward to any program updates in the Jazz Q4 sales report coming later this week. Vaxnivans is a pneumococcal vaccine utilizing ligand's CRM197 vaccine carrier protein produced using our former Pelican Expression technology platform. Work is now marketing Vaxnivans in both the adult population and the pediatric population. We're going to announce $176,000,000 in Vaxnivant sales in Q4 2023. Speaker 300:15:49Full year sales for the product came in at 665,000,000 dollars Ligand earns a low single digit royalty on vaccine based sales. Turning to Slide 11, we list a selection of our partner pipeline products that will have meaningful clinical or regulatory catalysts in the coming year. The 1st program on the list is ZELTUBEIN. Flying and acquired this product through our Novant acquisition in 2023, subsequently received approval for the program on January 5, 2024. Delsuvi is approved for the treatment of molluscum contagiosum in adults and pediatric patients 1 year of age or older. Speaker 300:16:24Delsuvi is the 1st and only topical prescription medication can be applied by patients, parents or caregivers at home outside of a physician's office or other medical setting and it's used to treat this highly contagious viral skin infection. Team is extremely excited about the potential for this program. We're in process of building a new standalone company called Palthos Therapeutics that will commercialize Zelsutme. Company creation effort is very similar to our prior efforts related to Viking Therapeutics and Primrose Bio. Palthos will be operated fully independent of Ligand, but we expect to own a significant equity stake in the business at inception. Speaker 300:17:02While we are having discussions with potential strategic licensing partners, we're also making good progress towards the creation of PELTHOS and the launch of Delsutme. We expect that PELTHOS will launch Delsutme in late 2024 and the program will join our key contributors to Ligand's royalty revenue line. Verona submitted its NDA to the FDA in June 2023 for approval of ensifentrine for the maintenance treatment of patients with COPD. PDUFA date for the product has been established as June 26, 2024 and Verona is building its commercial infrastructure as we speak. Vigand benefits from a low single digit royalty on ensifentrine and we believe the program will be another of our key growth drivers. Speaker 300:17:42Ensifentrine is a 1st in class drug candidate using a novel mechanism of action combining tool inhibition of PDE3 and PDE4. Verona estimates that there are over 8,000,000 COPD patients currently receiving chronic treatment in the U. S. Alone, over half of whom are dissatisfied with their current treatment regimen. If approved, ensifentrine could offer an effective and highly safe and tolerable add on or alternative treatment to address both symptoms and exacerbations. Speaker 300:18:10Mark is developing V114 as part of its pneumococcal vaccine franchise. V116 is targeted specifically at adults and has shown benefits over the existing standard of care. After reporting positive Phase 3 data last year in June and filing a BLA in November, there's now a PDUFA date of June 17, 2024. With successful approval, we believe V114 will continue to drive the Merck franchise growth benefit ligand through our low single digit royalty. Merck received breakthrough therapy designation for V116 and if approved V116 would be the 1st pneumococcal conjugate vaccine specifically designed to address the serotypes that cause post adult invasive pneumococcal disease. Speaker 300:18:52Takeda is developing cotyclostat, which is a 1st in class novel compound with the potential to reduce seizure susceptibility. Takeda is currently running 2 Phase III trials and expects data in its fiscal year 2024. Ligand earns a tiered royalty of up to 20 2.6% on this drug if successfully commercialized as well as up to $86,000,000 of milestones. There remains high unmet need in rare pediatric epilepsies and cetiklostat is uniquely positioned to deliver value to patients and caregivers through its demonstrated seizure reduction capability as well as its strong safety profile and ability to be combined with a broad range of antiepileptic treatments. Finally, during the Q2 of 2023, Viking announced positive top line results from the Phase 2b voyage study evaluating VK2809 in patients with biopsy confirmed NASH. Speaker 300:19:42The company expects to report data from the secondary and exploratory objectives of the VOIAGE study, including the evaluation of histologic changes assessed by hepatic biopsy over 52 weeks of treatment in the first half of twenty twenty four. Expect that following these results Viking would move forward into Phase 3 with this important program. Viking earns a 3.5% to 7.5% royalty on potential sales of VK2809 as well as significant clinical, regulatory and commercial milestones. NASH is a very large potential market and if Viking is successful in their development, products in this category are estimated to be multibillion dollar opportunities. On Slide 10, I'll provide sorry, excuse me, on Slide 12, I'll provide an update on our Captisol business. Speaker 300:20:24Core Captisol sales for 2023 outperformed our expectation for the year. Customer demand remains strong for both clinical and commercial Captisol as partners continue to find benefit from our technology platform. 2023 saw 6 new partner agreements and we've already signed a few more in 2024. Last month, we saw Eisai announce the approval of their IV formulation of their drug Vycompa. That marks the 16th approved Captisol enabled drug around the world and we see the potential for another 4 approvals in 2024. Speaker 300:20:54Traction on this business is exemplified by the number and pace of approvals as well as the volume of material that we've sold since acquiring the business. In addition to highlighting the names of all 16 approved drugs along with their timing of approval, the chart on the right shows vertical bars annually that represent the cumulative volume of Captisol that we've sold and demonstrates the continued momentum of the business. We report our Captisol sales on a separate line from our royalties. This business is another of our major drivers of revenue, cash flow and profitability. Gross profit from Captisol in 2023 equated to about $17,000,000 which exceeded our largest current single royalty other than Kyprolis. Speaker 300:21:33That concludes my summary of portfolio highlights and I'll turn the call back over to Tavo for financial update. Tavo? Thanks, Matt. First, I want to highlight that Speaker 100:21:43I will be discussing non GAAP results, which exclude certain items including stock based compensation, amortization of intangible assets, unrealized gains from short term investments, our share of losses absorbed from accounting or our investment in Primrose Bio under the equity method, expenses incurred to incubate the recently acquired Novean business amongst others. In addition, to help investors discern the performance of our core business results, we subtract Captisol sales related to COVID-nineteen and realized gains from the sale of Viking Therapeutics stock. 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 delivered strong results in 2023 that met or exceeded the high end of our guidance range, with total revenue of $131,000,000 and core adjusted earnings per share of 4 and $70,000,000 in cash and investments and no debt on the balance sheet. Slide 14 frames up our financial results in more detail for both the Q4 and the full year. Speaker 100:22:49I'll focus my discussion first on the full year results. Excluding last year's contribution from COVID Captisol sales, total 2023 revenue grew 21% versus 2022. Royalty revenue increased 16% to $83,900,000 from $72,500,000 a year ago with the growth driven by strength in Amgen's Kyprolis, Yazys Rylase and Merxivax Nuvance. The increase in royalty revenue was offset by a decrease in teriparatide. We have been anticipating generic competition to enter the market and it appears that may beginning to materialize. Speaker 100:23:26Amgen reported total 2023 Kyprolis sales of 1 point $4,000,000,000 which was 13% above the prior year and they attributed most of the increase to volume growth. Work announced total sales of $665,000,000 for Rexnivans, which is an almost 300% increase over 2022. We believe these products along with Rylase and Filspari will continue to drive royalty revenue growth in the future. Captisol sales were $28,400,000 in 2023 versus core Captisol sales of $16,400,000 in 2022 with the increase due to timing of customer orders. Total Captisol sales in 2022 were $104,500,000 with $88,100,000 of that related to COVID-nineteen. Speaker 100:24:11We did not have any COVID-nineteen related Captisol sales this year. Contract revenue this year was $19,000,000 versus $19,200,000 in 2022. Total R and D and G and A operating expenses decreased by 27% in 2023, primarily to lower headcount related expenses associated with the spin out of Pelican. The decrease in operating expenses was offset by investments made to build up our investment team in Boston as well as the increase in expenses associated with incubating the Nogand business. G and A and R and D expenses were $52,800,000 dollars 24,500,000 in 2023 versus $70,100,000 $36,100,000 in 2022 respectively. Speaker 100:24:54GAAP net income in 2023 was $53,600,000 or $3.02 per diluted share versus GAAP net loss of 5,200,000 or $0.31 per share in 2022. The increase in GAAP net income is due largely to the increase in operating income and gains from short term investments due to the increase in value on our holdings of Viking stock. Excluding the impact of gains from sales of Viking stock and COVID-nineteen Captisol sales, core adjusted net income was $71,600,000 or $4.06 per diluted share in 2023 versus $41,900,000 or $2.44 per diluted share in 2022. Adjusted net income for 2023 was $107,300,000 or $6.08 per diluted share compared with $82,200,000 or $4.79 per diluted share in 2022. Now focusing on the quarter. Speaker 100:25:54All revenue for the quarter increased about 5% excluding COVID-nineteen Captisol sales in Q4 2022. Royalty revenue overall increased slightly driven by Kyprolis, Rylase, Vaxnuban and FilSpari, offset by a decrease in teriparatide. Total operating expenses are lower compared to the prior year quarter, large part due to the spin out of Pelican, offset by investments made and building up our investment team in Boston as well as costs associated with the Novan business. As mentioned on our 3rd quarter earnings call, we expect to incur incremental operating costs associated with incubating the Novan business. Our intent is to spin out and or out license the Novan business and therefore we are adjusting out these expenses for purposes of reporting adjusted non GAAP earnings. Speaker 100:26:43GAAP net income for the Q4 of 2023 was $18,000,000 or $1.02 per diluted share versus GAAP net loss of $14,500,000 or $0.86 per share in the Q4 of 2022. The increase in GAAP net income is due largely to gains from short term investments as a result of the increase in value on our holdings of Viking stock as well as lower operating expense. Excluding the impact of gains from Viking stock and COVID-nineteen Captisol sales, core adjusted net income was $18,500,000 or $1.05 per share in Q4 2023 versus $13,000,000 or $0.75 per share in Q4 20 22. Adjusted net income for the Q4 of 2023 was $24,300,000 or $1.38 per share compared with $23,500,000 or $1.36 per share in the prior year quarter. Turning to the balance sheet. Speaker 100:27:41As of December 31, 2023, net cash and short term investments of $170,000,000 which includes $32,000,000 of our holdings in Viking common stock. We expect that current cash plus annual cash flow generation will be sufficient to fund the investment activity we anticipate over the foreseeable future. Turning now to guidance on slide 15. We are reaffirming the 2024 financial guidance we introduced at Investor Day in December. We expect 2024 royalty revenue will be in the range of $90,000,000 to $95,000,000 sales of Captisol sales in the range of $25,000,000 to $27,000,000 and contract revenue in the range of $15,000,000 to $20,000,000 These revenue components result in total revenue guidance of $130,000,000 to $142,000,000 and adjusted earnings per diluted share of $4.25 to $4.75 And as Todd mentioned, we also introduced in December for the first time and we reiterate today a longer term outlook where we see royalty revenue growing at a compound annual growth rate above 20% from 2022 to 2028 and adjusted core EPS growing even faster at a compound annual growth rate above 25%. Speaker 100:29:02As a reminder, we exclude Captisol for COVID-nineteen related sales from guidance and we'll update investors as orders are received and shipped each quarter. Finally, I'd like to direct listeners to our Q4 earnings press release issued earlier today, which is available on our website for a reconciliation of our adjusted financial results to the GAAP results I talked about today. I'll now turn the call over to Todd for closing comments. Speaker 200:29:27Thank you, Thabo. In summary, we are very pleased with our 2023 financial results as well as the progress we've made over the last year improving our investment capabilities and growing our asset portfolio. Our diversified portfolio including our major commercial royalty generating programs and late stage pipeline form the foundation for compounding growth. 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 2020 4 and deliver attractive growth and shareholder returns over the long term. Speaker 200:30:09Thank you everyone for joining us for today's earnings call and we will now pass it back to the operator and open it up for questions. Operator00:30:19Thank you, sir. Our first question comes from the line of Matt Hewitt from Craig Hallum Capital Group. Please go ahead. Speaker 400:30:37Good morning and congratulations on the strong finish to the year. I guess several different topics, maybe the first one regarding the Palfos opportunity, how should we be thinking about timing and potential structure of partnership or your intentions with that operating asset? Speaker 300:31:01Thanks, Matt. Yes, so as very similar to what we've done in the past creating Primrose Bio recently and back in 2014, 2015, creating Viking and then eventually spinning out Viking as a standalone company in 2015 with the IPO. One of the things that we're pursuing with the Novant assets is creating this company called Palthos Therapeutics that is just getting started that will create as a standalone independent company, and we will seek external capital to fund at least a portion of. And then Ligand would license it assets the same way we licensed Viking 4 or 5 assets and set it up as a standalone company. And that company will be prepared to commercialize and launch the product later this year when the product is ready to be launched. Speaker 300:32:00So it's one avenue that we're exploring and right now it's the one that we think is pretty high probability, but we're exploring all alternatives including a licensing asset to a strategic. Speaker 500:32:14Got it. That's helpful. Speaker 400:32:15And then regarding your contract and milestone guidance for this year, $15,000,000 to $20,000,000 With 2 PDUFA dates in Q2, should would it make sense to be factoring in a little bit more heavy weighting, if you will, in that quarter, maybe kind of assuming 1 of the 2 has a positive outcome? Or how should we be thinking about the cadence for the contract revenues? Speaker 300:32:44Yes. Tabo is taking a look just to make sure we have the numbers correct. But as we've talked about, there's an approval milestone for the ensifentrine asset that is about US5 $1,000,000 that will hit if it's approved in June as expected. So other than that one big milestone, I don't think there's anything else to have with any other Speaker 100:33:09Yes. There's the Travir European approval and a number of other milestones that we probability risk adjust. And so that's we do take the PDUFA dates into consideration at arriving at a range there. Speaker 400:33:28Okay. Got it. And then maybe one last one for me as far as you touched on this a little bit, obviously, you've built out a really strong team to evaluate potential investment opportunities. You've got a nice backlog there funnel, if you will. As far as timing is concerned, is it really just about when the deals come together versus are you targeting, hey, we'd like to have 2 this quarter, 2 next quarter? Speaker 400:33:55How should we be thinking about the timing on those? Thank you. Speaker 200:33:59Yes. The timing on these has to be flexible because you want to make sure you get all the way through diligence and you don't have a deal done until you clear diligence and final terms. So there is as there is in any investment business, there'll be periods where there's a lack of activity seemingly in terms of closes and then there'll be periods where there's significant activity in terms of closes. But there's always this underlying deal activity going on where you're originating deals, evaluating, screening, taking a certain number of those that pass the screen into deeper diligence. And then without perfect predictability a certain amount of those get to a close. Speaker 200:34:48So there's just a natural process to this and we don't want to commit to closing a certain number of deals or certain timing within a year because you really want the flexibility to maintain investment discipline around that process. Operator00:35:08You. Our next question comes from the line of Laurent Solow from CJS Securities. Please go ahead. Speaker 500:35:14Hi, good morning. Larry Works. Just a couple of questions. I guess first question just on the and you guys called it out on the royalties a little bit down versus Q3 and usually they're tiering up. So and you called out teriparatide as the driver behind that. Speaker 500:35:30Just curious as you look out to 2024, a few moving parts here. Does the teriparatide number in that guidance, does that lower now? Is there an offset to that? Had you kind of expected that? I guess it was only a couple of months ago. Speaker 500:35:48And then I guess just on the royalty outlook, I guess you kind of mentioned the sales bar consensus is like 110. So I guess are you guys kind of assuming that number in your guidance? Maybe you can just give us a little color on those couple of moving parts. Speaker 100:36:02Yes. Thanks, Larry. Yes, so we're reiterating what we said in December. We've learned a little bit more since including the new consensus number for Filspari. There's a little bit of upside there. Speaker 100:36:17We think that the drivers will continue to be Kyprolis, ZUVAC, NuVance, Ryley's. And we have been prudent on teriparatide and we continue to be prudent going into the year. So we've we are seeing competition come in. We haven't received the full report yet from Alvogen, so there's still more to be learned, but we have been conservative in our assumptions. Speaker 500:36:43Got it. And you're not assuming anything for XELSUMA in this year, correct? Speaker 200:36:48No. Speaker 500:36:49Okay. And then just thoughts of Varona, obviously the product and severance is in their hands, but and then you mentioned I think that they've gotten some financing. So the current belief today is that they expect to launch that themselves. Obviously, COPD, a huge market, a lot of marketing expense and big pharma in there dominated by big pharma. Is that something they're going to try and go up against or are they actively looking for a partner? Speaker 200:37:17Yes. Terry, we have no obviously specific knowledge on their plan, but they have a strong team and have over the last couple of years built that up, so they have the ability to launch this themselves. And that is our assumption in terms of our forecast and guidance around the product. But obviously there is we think significant upside around a potential larger acquisition and this is a product within a category where we certainly think some of the larger folks should be interested in this asset because it's the first significant innovation in the maintenance of COPD in a long time. Speaker 500:38:01Absolutely. That makes sense. And just lastly, could you just remind us how many shares of VKTX you guys have currently? Speaker 200:38:09We still hold about 1,700,000 shares of Viking Therapeutics. Speaker 500:38:15Got it. Okay. Appreciate that. Thanks, Todd. Operator00:38:21Thank you. Our next question comes from the line of Balaji Prasad of Barclays. Please go ahead. Speaker 100:38:34Hi, good morning. This is Shao on for Balaji. Thanks for taking our question. Just a quick one on Riley. Could you add a little bit more color on your comments with regard to the supply constraints? Speaker 100:38:45And could you also share your view on the short term and the long term revenue ramp up of this asset and the implications for Ligand's portfolio? Thank you so much. Speaker 300:38:55Thanks. As folks know, Rylase is marketed by Jazz, our marketing partner. The supply constraints we were referring to in my prepared comments were really related to the predecessor product. Jazz and Pelican or Phoenix, our prior technology platform, collaborated to develop Rylase to solve those manufacturing problems historically. And so those are all resolved now and the new product is fully available as much as needed from a manufacturing standpoint. Speaker 300:39:36In terms of projections for the product or comments on the product's potential, we only can report what our partners report and Jazz did not provide guidance for Rylase. I'd point folks to the publicly reported consensus estimates for the product. But last year, the product did about $400,000,000 a little bit less, I think, for the year. And we hope to see growth given that Jazz highlighted that as one of its 3 key growth drivers. Got it. Speaker 300:40:09Thanks. Operator00:40:18There are no further questions at this time. Thank you, ladies and gentlemen. We will conclude today's conference call. We thank you for participating. You may now disconnect.Read moreRemove AdsPowered by Conference Call Audio Live Call not available Earnings Conference CallLigand Pharmaceuticals Q4 202300:00 / 00:00Speed:1x1.25x1.5x2xRemove Ads Earnings DocumentsPress Release(8-K)Annual report(10-K) Ligand Pharmaceuticals Earnings HeadlinesJ&J kicks off pharma earnings season with guidance raise amid looming tariffsApril 15 at 9:35 AM | msn.comLigand Pharmaceuticals (NASDAQ:LGND) Stock Rating Upgraded by StockNews.comApril 15 at 1:43 AM | americanbankingnews.comNow I look stupid. Real stupid... I thought what happened 25 years ago was a once- in-a-lifetime event… but how wrong I was. Because here we are, a quarter of a century later, almost to the exact day, and it’s happening again. April 16, 2025 | Porter & Company (Ad)Ligand initiated with a Buy at StifelApril 11, 2025 | markets.businessinsider.comStifel Initiates Coverage of Ligand Pharmaceuticals (LGND) with Buy RecommendationApril 11, 2025 | msn.comThis Ligand Pharmaceuticals Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For ThursdayApril 10, 2025 | benzinga.comSee More Ligand Pharmaceuticals Headlines Get Earnings Announcements in your inboxWant to stay updated on the latest earnings announcements and upcoming reports for companies like Ligand Pharmaceuticals? Sign up for Earnings360's daily newsletter to receive timely earnings updates on Ligand Pharmaceuticals and other key companies, straight to your email. Email Address About Ligand PharmaceuticalsLigand Pharmaceuticals (NASDAQ:LGND), a biopharmaceutical company, engages in the development and licensing of biopharmaceutical assets worldwide. Its commercial programs include Kyprolis and Evomela, which are used to treat multiple myeloma; Rylaze, a recombinant erwinia asparaginase for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma in adult and pediatric patients; Filspari, a dual endothelin and angiotensin II receptor antagonist in development for rare kidney diseases and non-immunosuppressive treatment indicated for immunoglobulin A nephropathy; Teriparatide injection product for osteoporosis; Vaxneuvance for the prevention of invasive disease caused by streptococcus pneumoniae serotypes; and Pneumosil, a pneumococcal conjugate vaccine to help fight against pneumococcal pneumonia among children. The company also offers TZIELD, a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and children aged 8 years and older with Stage 2 T1D; Nexterone, a captisol-enabled formulation of amiodarone; Zulresso, a captisol-enabled formulation of brexanolone for the treatment of postpartum depression; and Veklury, an antiviral treatment for moderate or severe COVID-19. In addition, it provides Noxafil-IV, a captisol-enabled formulation of posaconazole for IV use; Duavee for the treatment of post-menopausal symptoms in women; Exemptia for autoimmune diseases; Vivitra for breast cancer; and Bryxta and Zybev for various indications. The company has alliances, licenses, and other business relationships with Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences, and Baxter International. Further, it sells Captisol materials. Ligand Pharmaceuticals Incorporated was incorporated in 1987 and is based in Jupiter, Florida.View Ligand Pharmaceuticals ProfileRead more More Earnings Resources from MarketBeat Earnings Tools Today's Earnings Tomorrow's Earnings Next Week's Earnings Upcoming Earnings Calls Earnings Newsletter Earnings Call Transcripts Earnings Beats & Misses Corporate Guidance Earnings Screener Earnings By Country U.S. Earnings Reports Canadian Earnings Reports U.K. Earnings Reports Latest Articles Tesla Stock Eyes Breakout With Earnings on DeckJohnson & Johnson Earnings Were More Good Than Bad—Time to Buy? Why Analysts Boosted United Airlines Stock Ahead of EarningsLamb Weston Stock Rises, Earnings Provide Calm Amidst ChaosIntuitive Machines Gains After Earnings Beat, NASA Missions AheadCintas Delivers Earnings Beat, Signals More Growth AheadNike Stock Dips on Earnings: Analysts Weigh in on What’s Next Upcoming Earnings Netflix (4/17/2025)American Express (4/17/2025)Blackstone (4/17/2025)Infosys (4/17/2025)Marsh & McLennan Companies (4/17/2025)Charles Schwab (4/17/2025)Taiwan Semiconductor Manufacturing (4/17/2025)UnitedHealth Group (4/17/2025)HDFC Bank (4/18/2025)Intuitive Surgical (4/22/2025) Get 30 Days of MarketBeat All Access for Free Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools. Start Your 30-Day Trial MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
There are 6 speakers on the call. Operator00:00:00Ladies and gentlemen, thank you for standing by. Welcome everyone to the Ligand Fourth Quarter 2023 Earnings Webcast. At this time, 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. Operator00:00:22I will now hand the call over to Tavo Espinosa, Chief Financial Officer. You may begin your conference. Speaker 100:00:30Hello, everyone, and welcome to our earnings call for the Q4 and year end 2023. During the call today, we will review the financial results we released prior to today's market open and offer commentary on our partner pipeline and business development activity, after which we will host a question and answer session. Our earnings release can be found in the Investor Relations section of our website at ligand.com. Participating for Ligand today will be our CEO, Todd Davis our COO, Matt Kornberg and myself, Tava Espinosa, CFO. This call is being recorded and the audio portion will be archived in the Investors section of our website. Speaker 100:01:05It is our intent that all forward looking statements regarding our financial results and commercial activity made during today's call will be protected under the Private Securities Litigation Reform Act of 1995. Forward looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward looking statements are based upon current available information and 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 has filed with the Securities and Exchange Commission, including our most recent Forms 10 Q and 10 ks. Speaker 100:01:46With that, I will now turn the call over to Todd. Speaker 200:01:49Thank you, Thabo, and welcome to everyone on the call. The end of 2023 marks the completion of my first full year as CEO of Ligand. And I'm happy to say that in the last year, we've successfully transformed the company to take Ligand to the next stage of growth. Slide 3 summarizes our financial and portfolio achievements in 2023, which underscores our strong momentum and the strength of our business model. 1st, we delivered strong financial performance. Speaker 200:02:21We grew revenue by more than 20% when you exclude last year's COVID related Captisol sales, while reducing 2023 cash operating expenses from above $90,000,000 per year to below $40,000,000 per year. This resulted in core adjusted diluted earnings per share of $4.06 which is 66% above the prior year. 2nd, we streamlined and improved the financial profile of the business through restructuring efforts. In addition to spinning out the OmniAb business, we also divested our Pelican protein expression platform via Equity Merger or Spinout to form Primrose Bio. Both of these businesses are valuable technology platforms, but they required additional investment in infrastructure that was inconsistent with our core financial strategy. Speaker 200:03:17This enabled a headcount reduction from over 170 to 35 employees. This operational streamlining was completed even while adding significant talent in the investment, portfolio management and diligence functions to create a premier investment team. Accordingly, that team began to execute on our newly refined strategy in the second half of twenty twenty three. 3rd, we strengthened our royalty portfolio by adding several innovative and exciting new programs, including Sanofi's TZIELD and Takeda's saticlostat. We also expanded existing partnerships acquiring full rights to the recently approved ZILSUVME and expanding a royalty investment in Palvella's PTX-twenty two program, which is in development for microcystic lymphatic malformations. Speaker 200:04:134th, as shown on Slide 4, at our Investor Day in December, we announced for the first time a longer term outlook where we see royalty revenue CAGR of over 20% and an adjusted EPS CAGR exceeding 25% over the next 5 years. The breadth of our asset portfolio provides us with a lower volatility and much greater predictability than is typical in biotech businesses, which in turn provides us the confidence to share these longer term projections. The forecast is driven by our current major commercial programs, our existing pipeline and the expected contribution from the new business development efforts. Tago will cover our financials in a little more detail, but I'd like to highlight that the increase in Viking Therapeutics stock price in 2023 has bolstered our balance sheet as we generated approximately $80,000,000 in proceeds from the sale of Viking shares and still hold approximately 1,700,000 shares. We are reinvesting these proceeds into new investments that will drive additional growth and value creation in the future. Speaker 200:05:29Also, there are several exciting developments across our partnered commercial portfolio and clinical pipeline. During late 2023 early 2024 and there is an opportunity for further value creation through additional important catalysts expected this year. On January 5, 2024, the FDA approved zelsoopnee as a first in class medication for the treatment of molluscum contagiosum in adults and pediatric patients 1 year of age or older. Dilsudmi is the 1st and only prescription medication that can be applied by patients, parents or caregivers at home outside of the physician's office to treat this highly contagious infection. You may recall that we own 100 percent of Zilsupmy rights after funding Novan through a restructuring process and acquiring a significant portion of their assets in 2023. Speaker 200:06:26Additionally, we have 2 partnered products that have PDUFA dates scheduled during June of 2024, Verona's ensifentrine and Merck's V116. Ensifentrine, if approved, is expected to be the 1st novel mechanism available for the maintenance treatment of COPD in more than 10 years. Additionally, the FDA accepted for priority review Merck's new BLA for V114 an investigational 21 valent pneumococcal conjugate vaccine specifically designed to help prevent invasive pneumococcal disease and pneumonia in adults. Our royalty rates on ensifentrine and D116 are in the low single digit royalty range. Finally, Trevir announced that it received 4 59 new patient start forms for Valspari in the Q4 of 2023 and announced net product sales of approximately $15,000,000 for the Q4, which is an increase of over 80% from the prior quarter. Speaker 200:07:31We have a 9% royalty on TILSPARI and consensus estimates continue to show $500,000,000 to $1,000,000,000 in peak TILSPARI sales. Shortly, Matt will provide more detail around these and other programs. Now let's turn to our business development efforts. In 2023, one of our key priorities was assembling a strong and experienced investment team to execute on our strategy and we are pleased with our progress in this regard. Additionally, I can share today that we've recently added Rich Baxter and Doctor. Speaker 200:08:06Karen Reeves to the team. Rich joins us as SVP of Investment Operations and a member of the Investment Committee. Rich brings significant commercial pharmaceutical industry experience and private equity investment experience. He co founded the healthcare group for Drawbridge Special Opportunities Fund at Fortress Investment Group, which invested approximately $1,000,000,000 in emerging life science companies. He also served as Co Head of the Healthcare team at Hayfin Capital Management, which deployed $1,400,000,000 in capital over 4 years. Speaker 200:08:43Karen is a Board certified position and joins us as SVP of Clinical Strategy and Investments. She brings more than 20 years of experience in senior roles at top pharmaceutical companies with extensive experience in successful Phase 1 to Phase 4 drug development across multiple therapeutic areas. Most recently, she served as President and Chief Medical Officer of AZ Therapies, a private late stage clinical biopharmaceutical company focused on neurology. Prior to AZ Therapies, Karen held multiple leadership positions at Pfizer including VP Worldwide R and D, VP Worldwide Safety and Regulatory and Head of Global Clinical Submissions for Quality. We welcome both Karen and Rich to the Ligand team. Speaker 200:09:36Paul Hadden has been leading our investment origination efforts and was instrumental in increasing our available opportunity set during 2023. Last year, we reviewed over 300 investment opportunities, signed 45 CDAs and closed 5 transactions. We entered 2024 with 130,000,000 dollars in cash, plus we expect to generate approximately $80,000,000 in cash from operations this year. Adding to this is our ownership in Viking Therapeutics stock and a $75,000,000 revolving credit facility. With this strong financial position, we feel we are well positioned to have another successful year led by investment activity, providing exciting growth opportunities for Ligand. Speaker 200:10:28As we discussed in December, the team has built a robust pipeline of investment opportunities that span both significant breadth of therapeutic area, but also diversified transaction types. We are in active dialogue with multiple counterparties and are constantly looking for new exciting opportunities in which to invest capital. The team is currently reviewing approximately $400,000,000 in investment opportunities across multiple strategies including royalty monetization, project finance, M and A and special opportunities. As a reminder about our investment criteria, we are primarily focused on assets that are within a few years of approval in either Phase II or Phase III, are highly differentiated, offer significant value to patients, provide favorable market exclusivity and have above average probability of technical and regulatory success. Ultimately, the number and size of investments we make will depend on the quality of the opportunities we identify. Speaker 200:11:33We believe that we have the right team to execute and excel in this high margin agrowth strategy. It's important to note that the majority of our diligence assessment is done under confidentiality agreements, which provides us advantageous insight into our investment decisions. In summary, 2023 was an important year for Ligand in terms of our financial performance, strategic evolution, investment activity and team building efforts. With these accomplishments, we're looking forward to a busy and productive 2024. Now Matt will cover the portfolio highlights. Speaker 300:12:09Thanks, Todd. 2023 was a transformative year for Ligand. Today, I'll provide investors with an update on key developments from our partners across our commercial programs and our development portfolio. Ligand's portfolio includes more than 85 partnered programs that drive our royalty revenue, our Captisol material sales and our license milestone and contract revenue. Slide 10 shows our key commercial programs that drive the significant majority of our royalty revenue. Speaker 300:12:38Our current commercial portfolio includes over 25 different royalty streams and 30 commercial drivers overall. These 8 programs are expected to contribute over 95% of the royalty revenue in 2024. The team at Ligand is focused on adding additional names to this list. Many of those additions will come organically from our existing partnered pipeline portfolio and some will come through new investments generated out of our now established deal team as Todd mentioned. A few highlights from 2023. Speaker 300:13:07PYPROLIS, which is an important drug for multiple myeloma, continued its strong performance with another solid quarter in Q4. PYPROLIS is marketed by Amgen in a majority of the countries around the world as well as by Ono in Japan and by Beijing in China. Q4 2023, these companies reported combined quarterly revenue of over 370,000,000 dollars Year over year growth for the product was driven principally by volume growth with 2023 reported sales exceeding $1,400,000,000 globally. We earn a tiered royalty of 1.5% to 3% on global sales and expect continued growth in 2024. Our partner Travir is marketing Filspari in the U. Speaker 300:13:45S. In IgA nephropathy. Travir reported revenue of $14,700,000 for Q4. Trevir also continued to disclose the momentum on new patient recruitment. Trevir had 4 59 new patient forms submitted in Q4, bringing the total since launch to 1452. Speaker 300:14:04The continued addition of potential new patients provides good evidence of future revenue potential that supports the consensus estimates for 2024 to return approximately $110,000,000 of revenue for the year. On the regulatory front, Premier announced that the EMA CHMP has recommended approval for sparsantan for the treatment of adults with primary IgA nephropathy. The company expects the EU approval decision in Q2 2024 and the full U. S. Approval decision in Q3 2024. Speaker 300:14:36We earned a 9% royalty on net sales and we expect that this will be a significant driver of our long term growth for our royalties. Rylase is marketed by our partner Jazz Pharmaceuticals as a component of a multi agent chemotherapeutic regimen for treatment of children and adults with ALL or LBO. This product continues to do extremely well in a market that was previously constrained by supply issues. At JPMorgan earlier this year, Jazz highlighted Rylase as one of its 3 key growth drivers. Having received approval for Rylase in Europe in September 2023, Jazz confirmed the 1st European country launch occurred before the end of last year and that additional European launches will continue on a rolling basis in 2024. Speaker 300:15:19In Q3 of 2023, Rylase generated $104,900,000 in sales. We look forward to any program updates in the Jazz Q4 sales report coming later this week. Vaxnivans is a pneumococcal vaccine utilizing ligand's CRM197 vaccine carrier protein produced using our former Pelican Expression technology platform. Work is now marketing Vaxnivans in both the adult population and the pediatric population. We're going to announce $176,000,000 in Vaxnivant sales in Q4 2023. Speaker 300:15:49Full year sales for the product came in at 665,000,000 dollars Ligand earns a low single digit royalty on vaccine based sales. Turning to Slide 11, we list a selection of our partner pipeline products that will have meaningful clinical or regulatory catalysts in the coming year. The 1st program on the list is ZELTUBEIN. Flying and acquired this product through our Novant acquisition in 2023, subsequently received approval for the program on January 5, 2024. Delsuvi is approved for the treatment of molluscum contagiosum in adults and pediatric patients 1 year of age or older. Speaker 300:16:24Delsuvi is the 1st and only topical prescription medication can be applied by patients, parents or caregivers at home outside of a physician's office or other medical setting and it's used to treat this highly contagious viral skin infection. Team is extremely excited about the potential for this program. We're in process of building a new standalone company called Palthos Therapeutics that will commercialize Zelsutme. Company creation effort is very similar to our prior efforts related to Viking Therapeutics and Primrose Bio. Palthos will be operated fully independent of Ligand, but we expect to own a significant equity stake in the business at inception. Speaker 300:17:02While we are having discussions with potential strategic licensing partners, we're also making good progress towards the creation of PELTHOS and the launch of Delsutme. We expect that PELTHOS will launch Delsutme in late 2024 and the program will join our key contributors to Ligand's royalty revenue line. Verona submitted its NDA to the FDA in June 2023 for approval of ensifentrine for the maintenance treatment of patients with COPD. PDUFA date for the product has been established as June 26, 2024 and Verona is building its commercial infrastructure as we speak. Vigand benefits from a low single digit royalty on ensifentrine and we believe the program will be another of our key growth drivers. Speaker 300:17:42Ensifentrine is a 1st in class drug candidate using a novel mechanism of action combining tool inhibition of PDE3 and PDE4. Verona estimates that there are over 8,000,000 COPD patients currently receiving chronic treatment in the U. S. Alone, over half of whom are dissatisfied with their current treatment regimen. If approved, ensifentrine could offer an effective and highly safe and tolerable add on or alternative treatment to address both symptoms and exacerbations. Speaker 300:18:10Mark is developing V114 as part of its pneumococcal vaccine franchise. V116 is targeted specifically at adults and has shown benefits over the existing standard of care. After reporting positive Phase 3 data last year in June and filing a BLA in November, there's now a PDUFA date of June 17, 2024. With successful approval, we believe V114 will continue to drive the Merck franchise growth benefit ligand through our low single digit royalty. Merck received breakthrough therapy designation for V116 and if approved V116 would be the 1st pneumococcal conjugate vaccine specifically designed to address the serotypes that cause post adult invasive pneumococcal disease. Speaker 300:18:52Takeda is developing cotyclostat, which is a 1st in class novel compound with the potential to reduce seizure susceptibility. Takeda is currently running 2 Phase III trials and expects data in its fiscal year 2024. Ligand earns a tiered royalty of up to 20 2.6% on this drug if successfully commercialized as well as up to $86,000,000 of milestones. There remains high unmet need in rare pediatric epilepsies and cetiklostat is uniquely positioned to deliver value to patients and caregivers through its demonstrated seizure reduction capability as well as its strong safety profile and ability to be combined with a broad range of antiepileptic treatments. Finally, during the Q2 of 2023, Viking announced positive top line results from the Phase 2b voyage study evaluating VK2809 in patients with biopsy confirmed NASH. Speaker 300:19:42The company expects to report data from the secondary and exploratory objectives of the VOIAGE study, including the evaluation of histologic changes assessed by hepatic biopsy over 52 weeks of treatment in the first half of twenty twenty four. Expect that following these results Viking would move forward into Phase 3 with this important program. Viking earns a 3.5% to 7.5% royalty on potential sales of VK2809 as well as significant clinical, regulatory and commercial milestones. NASH is a very large potential market and if Viking is successful in their development, products in this category are estimated to be multibillion dollar opportunities. On Slide 10, I'll provide sorry, excuse me, on Slide 12, I'll provide an update on our Captisol business. Speaker 300:20:24Core Captisol sales for 2023 outperformed our expectation for the year. Customer demand remains strong for both clinical and commercial Captisol as partners continue to find benefit from our technology platform. 2023 saw 6 new partner agreements and we've already signed a few more in 2024. Last month, we saw Eisai announce the approval of their IV formulation of their drug Vycompa. That marks the 16th approved Captisol enabled drug around the world and we see the potential for another 4 approvals in 2024. Speaker 300:20:54Traction on this business is exemplified by the number and pace of approvals as well as the volume of material that we've sold since acquiring the business. In addition to highlighting the names of all 16 approved drugs along with their timing of approval, the chart on the right shows vertical bars annually that represent the cumulative volume of Captisol that we've sold and demonstrates the continued momentum of the business. We report our Captisol sales on a separate line from our royalties. This business is another of our major drivers of revenue, cash flow and profitability. Gross profit from Captisol in 2023 equated to about $17,000,000 which exceeded our largest current single royalty other than Kyprolis. Speaker 300:21:33That concludes my summary of portfolio highlights and I'll turn the call back over to Tavo for financial update. Tavo? Thanks, Matt. First, I want to highlight that Speaker 100:21:43I will be discussing non GAAP results, which exclude certain items including stock based compensation, amortization of intangible assets, unrealized gains from short term investments, our share of losses absorbed from accounting or our investment in Primrose Bio under the equity method, expenses incurred to incubate the recently acquired Novean business amongst others. In addition, to help investors discern the performance of our core business results, we subtract Captisol sales related to COVID-nineteen and realized gains from the sale of Viking Therapeutics stock. 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 delivered strong results in 2023 that met or exceeded the high end of our guidance range, with total revenue of $131,000,000 and core adjusted earnings per share of 4 and $70,000,000 in cash and investments and no debt on the balance sheet. Slide 14 frames up our financial results in more detail for both the Q4 and the full year. Speaker 100:22:49I'll focus my discussion first on the full year results. Excluding last year's contribution from COVID Captisol sales, total 2023 revenue grew 21% versus 2022. Royalty revenue increased 16% to $83,900,000 from $72,500,000 a year ago with the growth driven by strength in Amgen's Kyprolis, Yazys Rylase and Merxivax Nuvance. The increase in royalty revenue was offset by a decrease in teriparatide. We have been anticipating generic competition to enter the market and it appears that may beginning to materialize. Speaker 100:23:26Amgen reported total 2023 Kyprolis sales of 1 point $4,000,000,000 which was 13% above the prior year and they attributed most of the increase to volume growth. Work announced total sales of $665,000,000 for Rexnivans, which is an almost 300% increase over 2022. We believe these products along with Rylase and Filspari will continue to drive royalty revenue growth in the future. Captisol sales were $28,400,000 in 2023 versus core Captisol sales of $16,400,000 in 2022 with the increase due to timing of customer orders. Total Captisol sales in 2022 were $104,500,000 with $88,100,000 of that related to COVID-nineteen. Speaker 100:24:11We did not have any COVID-nineteen related Captisol sales this year. Contract revenue this year was $19,000,000 versus $19,200,000 in 2022. Total R and D and G and A operating expenses decreased by 27% in 2023, primarily to lower headcount related expenses associated with the spin out of Pelican. The decrease in operating expenses was offset by investments made to build up our investment team in Boston as well as the increase in expenses associated with incubating the Nogand business. G and A and R and D expenses were $52,800,000 dollars 24,500,000 in 2023 versus $70,100,000 $36,100,000 in 2022 respectively. Speaker 100:24:54GAAP net income in 2023 was $53,600,000 or $3.02 per diluted share versus GAAP net loss of 5,200,000 or $0.31 per share in 2022. The increase in GAAP net income is due largely to the increase in operating income and gains from short term investments due to the increase in value on our holdings of Viking stock. Excluding the impact of gains from sales of Viking stock and COVID-nineteen Captisol sales, core adjusted net income was $71,600,000 or $4.06 per diluted share in 2023 versus $41,900,000 or $2.44 per diluted share in 2022. Adjusted net income for 2023 was $107,300,000 or $6.08 per diluted share compared with $82,200,000 or $4.79 per diluted share in 2022. Now focusing on the quarter. Speaker 100:25:54All revenue for the quarter increased about 5% excluding COVID-nineteen Captisol sales in Q4 2022. Royalty revenue overall increased slightly driven by Kyprolis, Rylase, Vaxnuban and FilSpari, offset by a decrease in teriparatide. Total operating expenses are lower compared to the prior year quarter, large part due to the spin out of Pelican, offset by investments made and building up our investment team in Boston as well as costs associated with the Novan business. As mentioned on our 3rd quarter earnings call, we expect to incur incremental operating costs associated with incubating the Novan business. Our intent is to spin out and or out license the Novan business and therefore we are adjusting out these expenses for purposes of reporting adjusted non GAAP earnings. Speaker 100:26:43GAAP net income for the Q4 of 2023 was $18,000,000 or $1.02 per diluted share versus GAAP net loss of $14,500,000 or $0.86 per share in the Q4 of 2022. The increase in GAAP net income is due largely to gains from short term investments as a result of the increase in value on our holdings of Viking stock as well as lower operating expense. Excluding the impact of gains from Viking stock and COVID-nineteen Captisol sales, core adjusted net income was $18,500,000 or $1.05 per share in Q4 2023 versus $13,000,000 or $0.75 per share in Q4 20 22. Adjusted net income for the Q4 of 2023 was $24,300,000 or $1.38 per share compared with $23,500,000 or $1.36 per share in the prior year quarter. Turning to the balance sheet. Speaker 100:27:41As of December 31, 2023, net cash and short term investments of $170,000,000 which includes $32,000,000 of our holdings in Viking common stock. We expect that current cash plus annual cash flow generation will be sufficient to fund the investment activity we anticipate over the foreseeable future. Turning now to guidance on slide 15. We are reaffirming the 2024 financial guidance we introduced at Investor Day in December. We expect 2024 royalty revenue will be in the range of $90,000,000 to $95,000,000 sales of Captisol sales in the range of $25,000,000 to $27,000,000 and contract revenue in the range of $15,000,000 to $20,000,000 These revenue components result in total revenue guidance of $130,000,000 to $142,000,000 and adjusted earnings per diluted share of $4.25 to $4.75 And as Todd mentioned, we also introduced in December for the first time and we reiterate today a longer term outlook where we see royalty revenue growing at a compound annual growth rate above 20% from 2022 to 2028 and adjusted core EPS growing even faster at a compound annual growth rate above 25%. Speaker 100:29:02As a reminder, we exclude Captisol for COVID-nineteen related sales from guidance and we'll update investors as orders are received and shipped each quarter. Finally, I'd like to direct listeners to our Q4 earnings press release issued earlier today, which is available on our website for a reconciliation of our adjusted financial results to the GAAP results I talked about today. I'll now turn the call over to Todd for closing comments. Speaker 200:29:27Thank you, Thabo. In summary, we are very pleased with our 2023 financial results as well as the progress we've made over the last year improving our investment capabilities and growing our asset portfolio. Our diversified portfolio including our major commercial royalty generating programs and late stage pipeline form the foundation for compounding growth. 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 2020 4 and deliver attractive growth and shareholder returns over the long term. Speaker 200:30:09Thank you everyone for joining us for today's earnings call and we will now pass it back to the operator and open it up for questions. Operator00:30:19Thank you, sir. Our first question comes from the line of Matt Hewitt from Craig Hallum Capital Group. Please go ahead. Speaker 400:30:37Good morning and congratulations on the strong finish to the year. I guess several different topics, maybe the first one regarding the Palfos opportunity, how should we be thinking about timing and potential structure of partnership or your intentions with that operating asset? Speaker 300:31:01Thanks, Matt. Yes, so as very similar to what we've done in the past creating Primrose Bio recently and back in 2014, 2015, creating Viking and then eventually spinning out Viking as a standalone company in 2015 with the IPO. One of the things that we're pursuing with the Novant assets is creating this company called Palthos Therapeutics that is just getting started that will create as a standalone independent company, and we will seek external capital to fund at least a portion of. And then Ligand would license it assets the same way we licensed Viking 4 or 5 assets and set it up as a standalone company. And that company will be prepared to commercialize and launch the product later this year when the product is ready to be launched. Speaker 300:32:00So it's one avenue that we're exploring and right now it's the one that we think is pretty high probability, but we're exploring all alternatives including a licensing asset to a strategic. Speaker 500:32:14Got it. That's helpful. Speaker 400:32:15And then regarding your contract and milestone guidance for this year, $15,000,000 to $20,000,000 With 2 PDUFA dates in Q2, should would it make sense to be factoring in a little bit more heavy weighting, if you will, in that quarter, maybe kind of assuming 1 of the 2 has a positive outcome? Or how should we be thinking about the cadence for the contract revenues? Speaker 300:32:44Yes. Tabo is taking a look just to make sure we have the numbers correct. But as we've talked about, there's an approval milestone for the ensifentrine asset that is about US5 $1,000,000 that will hit if it's approved in June as expected. So other than that one big milestone, I don't think there's anything else to have with any other Speaker 100:33:09Yes. There's the Travir European approval and a number of other milestones that we probability risk adjust. And so that's we do take the PDUFA dates into consideration at arriving at a range there. Speaker 400:33:28Okay. Got it. And then maybe one last one for me as far as you touched on this a little bit, obviously, you've built out a really strong team to evaluate potential investment opportunities. You've got a nice backlog there funnel, if you will. As far as timing is concerned, is it really just about when the deals come together versus are you targeting, hey, we'd like to have 2 this quarter, 2 next quarter? Speaker 400:33:55How should we be thinking about the timing on those? Thank you. Speaker 200:33:59Yes. The timing on these has to be flexible because you want to make sure you get all the way through diligence and you don't have a deal done until you clear diligence and final terms. So there is as there is in any investment business, there'll be periods where there's a lack of activity seemingly in terms of closes and then there'll be periods where there's significant activity in terms of closes. But there's always this underlying deal activity going on where you're originating deals, evaluating, screening, taking a certain number of those that pass the screen into deeper diligence. And then without perfect predictability a certain amount of those get to a close. Speaker 200:34:48So there's just a natural process to this and we don't want to commit to closing a certain number of deals or certain timing within a year because you really want the flexibility to maintain investment discipline around that process. Operator00:35:08You. Our next question comes from the line of Laurent Solow from CJS Securities. Please go ahead. Speaker 500:35:14Hi, good morning. Larry Works. Just a couple of questions. I guess first question just on the and you guys called it out on the royalties a little bit down versus Q3 and usually they're tiering up. So and you called out teriparatide as the driver behind that. Speaker 500:35:30Just curious as you look out to 2024, a few moving parts here. Does the teriparatide number in that guidance, does that lower now? Is there an offset to that? Had you kind of expected that? I guess it was only a couple of months ago. Speaker 500:35:48And then I guess just on the royalty outlook, I guess you kind of mentioned the sales bar consensus is like 110. So I guess are you guys kind of assuming that number in your guidance? Maybe you can just give us a little color on those couple of moving parts. Speaker 100:36:02Yes. Thanks, Larry. Yes, so we're reiterating what we said in December. We've learned a little bit more since including the new consensus number for Filspari. There's a little bit of upside there. Speaker 100:36:17We think that the drivers will continue to be Kyprolis, ZUVAC, NuVance, Ryley's. And we have been prudent on teriparatide and we continue to be prudent going into the year. So we've we are seeing competition come in. We haven't received the full report yet from Alvogen, so there's still more to be learned, but we have been conservative in our assumptions. Speaker 500:36:43Got it. And you're not assuming anything for XELSUMA in this year, correct? Speaker 200:36:48No. Speaker 500:36:49Okay. And then just thoughts of Varona, obviously the product and severance is in their hands, but and then you mentioned I think that they've gotten some financing. So the current belief today is that they expect to launch that themselves. Obviously, COPD, a huge market, a lot of marketing expense and big pharma in there dominated by big pharma. Is that something they're going to try and go up against or are they actively looking for a partner? Speaker 200:37:17Yes. Terry, we have no obviously specific knowledge on their plan, but they have a strong team and have over the last couple of years built that up, so they have the ability to launch this themselves. And that is our assumption in terms of our forecast and guidance around the product. But obviously there is we think significant upside around a potential larger acquisition and this is a product within a category where we certainly think some of the larger folks should be interested in this asset because it's the first significant innovation in the maintenance of COPD in a long time. Speaker 500:38:01Absolutely. That makes sense. And just lastly, could you just remind us how many shares of VKTX you guys have currently? Speaker 200:38:09We still hold about 1,700,000 shares of Viking Therapeutics. Speaker 500:38:15Got it. Okay. Appreciate that. Thanks, Todd. Operator00:38:21Thank you. Our next question comes from the line of Balaji Prasad of Barclays. Please go ahead. Speaker 100:38:34Hi, good morning. This is Shao on for Balaji. Thanks for taking our question. Just a quick one on Riley. Could you add a little bit more color on your comments with regard to the supply constraints? Speaker 100:38:45And could you also share your view on the short term and the long term revenue ramp up of this asset and the implications for Ligand's portfolio? Thank you so much. Speaker 300:38:55Thanks. As folks know, Rylase is marketed by Jazz, our marketing partner. The supply constraints we were referring to in my prepared comments were really related to the predecessor product. Jazz and Pelican or Phoenix, our prior technology platform, collaborated to develop Rylase to solve those manufacturing problems historically. And so those are all resolved now and the new product is fully available as much as needed from a manufacturing standpoint. Speaker 300:39:36In terms of projections for the product or comments on the product's potential, we only can report what our partners report and Jazz did not provide guidance for Rylase. I'd point folks to the publicly reported consensus estimates for the product. But last year, the product did about $400,000,000 a little bit less, I think, for the year. And we hope to see growth given that Jazz highlighted that as one of its 3 key growth drivers. Got it. Speaker 300:40:09Thanks. Operator00:40:18There are no further questions at this time. Thank you, ladies and gentlemen. We will conclude today's conference call. We thank you for participating. You may now disconnect.Read moreRemove AdsPowered by