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spk01: Ladies and gentlemen, thank you for standing by, and welcome to the Ligand Pharmaceuticals Q4 Earnings Conference Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star then 0. I would now like to hand the conference over to your speaker today, Patrick O'Brien. Thank you. Please go ahead.
spk02: Thank you, Brandi, and welcome to Ligand's fourth quarter of 2020 financial results and business update conference call. All of our speakers for today's call are in separate locations. Speaking today for Ligand will be John Higgins, CEO, Matt Fore, COO, and Matt Kornberg, CFO. We will use non-GAAP financial measures, and some of our statements will be forward-looking. Additional information concerning risk factors and other matters concerning Ligand can be found in our Ligand earnings press release, and our periodic filings with the SEC. Ligand undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. I would now like to turn the call over to John Higgins.
spk08: Good morning. Thanks for joining our fourth quarter 2020 earnings call. The past year was outstanding. The year was filled with opportunities and challenges, and through it all, Ligand had stellar financial scientific and operating performance as a life science technology company we are built upon diverse best-in-class technology platforms to serve our large portfolio of partners and customers our focus is to deliver investors a high growth business driven by our royalty-based contracts 2020 set the stage and we are now very well positioned for significant growth and expansion of the business in 2021 There have been four recent defining factors for Ligand driving our value. One, major expansion of our OmniApp antibody discovery platform. Two, the most prolific acquisition year in our history, diversifying and adding to our growth prospects. Three, serving Gilead to meet their Bechlery production needs to help address the ongoing global health crisis. And four, stellar financial performance. I will now expand on each of these four factors. First, I'll comment on the growth of our OmniApp business. We bought this platform five years ago, and over the past year, we made major investments in the technology and expanded the team to solidify Ligand's position as the industry-leading, best-in-class antibody discovery platform. OmniApp provides our partners with access to the world's most advanced antibody repertoires in screening technologies, to enable unparalleled discovery of next-generation therapeutics. It's a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry. At the heart of our OmniApp platform are both our AI-enhanced models and the biological intelligence, or the BI, of our proprietary transgenic animals that generate high-quality fully human antibodies optimized naturally through the animal systems. Partners seek out ligand due to the quality of our science, our discovery efficiency, and our proprietary inventions. We help partners create mono and bispecific antibodies that become leading drug candidates targeting some of the world's most challenging health needs. The antibody market is exploding in size with major new treatments coming to market at an increasing rate. Antibodies are also the largest area of R&D investment in the industry. We are pleased to see the recent increased visibility and valuations within the investment community for antibody drug discovery technologies with newly minted public companies, increasing consolidation through M&A, and existing participants moving up in value. Weigand is very well positioned as a leader as we have more and more partners, a growing roster of late-stage clinical trials, and a large number of potential regulatory approvals over the next five years. Recent market developments validate the upside potential for LIGAP. We see 2021 as a breakout year for this platform, given expected first-ever OmniAB drug regulatory approvals and key trial data from various programs due this year. Secondly, Quality acquisitions are driving our business opportunities and upside. 2020 was Ligand's most productive year ever for M&A, with four deals and nearly half a billion dollars deployed. The deals brought us earnings accretion, new partners, lucrative contracts, new laboratories, and 100 new scientists to expand our services. M&A is a particular strength for Ligand. Ten years ago, we bought Captisol, and five years ago, we acquired Omniab. Both acquisitions have been major unequivocal successes. The Ligand Strategy Team has good instincts for where to invest, driven by insight and collaboration with more than 125 corporate partners. We invest where the science is best and where it's heading. Our recent deals give you a sense for where we see major future opportunities. We are doubling down to the antibody space with two more tuck-in OmniApp acquisitions this past year, and we bought Icogen and Phoenix, giving us a premier position in the ion channel space and a proprietary protein expression platform. All the new operating units are successfully and fully integrated into Ligand and are projected to contribute meaningfully to our business in 2021. Thirdly, a major factor is our work with Gilead, meeting their immense needs for cactosol to manufacture Veclary, the COVID-19 treatment. Our work started more than a year ago now. It has been an all-consuming and rewarding mission, both scientifically and medically. Gilead relies on ligand's cactosol to formulate Veclary. Beyond delivering a necessary manufacturing ingredient that makes the drug possible, We are partners to Gilead in assisting and supporting an important element of the production work. Medical experts are suggesting COVID-19 will be endemic, meaning it's a disease that will be around to some degree for years to come. Our view today is that Veclary will remain a standard of care and a backbone to future therapies, and Veclary will continue to require Cactusol to make it for years to come, adding to our business long term. Finally, the fourth factor driving our success is our stellar financial performance. As Matt Kornberg will discuss, revenue and adjusted EPS for full year 2020 are both up more than 45% compared to last year. And robust performance is expected into 2021. Driving our performance are many new licensing contracts we signed this past year, more milestone payments for more partners, higher Capsasol sales, and the financial contribution from acquisitions. We have grown in cash flow and are investing in the business even more, hoping to further accelerate our partner revenue. Importantly, given our confidence in the business, we have made a strong investment in buying back Ligand stock. We have deployed over $500 million in the past two years, buying back more than 5 million shares, or 25% of our stock. The average price we paid is $104 per share. We reviewed a wide range of the options for capital deployment and saw the buyback of Ligand stock as an obvious, highly attractive, deep value opportunity. Now, with a reduction in shares outstanding, we have meaningfully increased the outlook for earnings and cash flow per share for all shareholders going forward. As I conclude my remarks, I want to add that Ligand is providing great service to our partners and executing efficiently. We have a very talented leadership team, a highly engaged, experienced board of directors, and a dedicated team of scientists driving the business. I want to acknowledge their hard work this past year and thank them for their excellent contributions. In parallel with our business success, we are a team that cares about our communities and the environment. We are dedicated to social equality and have implemented measures to help elevate our voice, and vocation for social justice. And we are implementing measures to reduce our carbon footprint and minimize consumables and other factors of production in running our technology. To do well, we need to do good. We encourage you to review the ESG reports on our website, follow us on Twitter, and review our upcoming proxy for additional disclosures on our environmental and social work. Our goal is to continue to expand our industry-leading technology offerings and to deliver the best year ever financially in Ligand's history, with guidance that calls for revenues increasing more than 50% and significant cash flow. What we do matters. We're contributing to the advancement of some vitally important medicines to advance human health. Now for a more detailed review of our financial results, I'll turn the call over to Matt Kornberg.
spk06: Thanks, John. The fourth quarter of 2020 was a fantastic end to another strong year from Ligand. Robust top line growth driven by our cap to sell material sales led the way in Q4, with strong financial results across the business. In addition, after closing the Phoenix transaction on the first day of the quarter, we spent the final months of the year integrating that business and team into Ligand, capping off a very busy strategic agenda for the year, that included four corporate acquisitions and the sale of our Vernalis business. We continued to generate significant cash, with 2020 resulting in our eighth consecutive year of strong earnings and positive cash generation. Our fourth quarter financial performance was the most robust of the year. Total revenue for the quarter was $70 million, up from $27 million a year ago, and included $11 million of royalty revenue, $41 million of cap to sell material sales, and $18 million of contract revenue. With respect to royalties, Kyprolis revenue of $272 million by Amgen for Q4 of 2020 was up over Q3 2020 and up year over year, despite the fact that sales in 2020 continue to be impacted by the pandemic. Ono, again, had an outstanding sales quarter for Kyprolis, posting $18.1 million in Q4, continuing its growth and reporting the largest quarter ever following the previous high in Q3 2020. Capital sales of $41 million in the quarter compared with $7.1 million a year ago, up more than five times the level in 2019, similar to our trends throughout 2020. Our contract revenue in Q4 2020 was $18 million compared with $8.8 million a year ago. With the increase driven by several OmniApp-related milestones and service payments, and our ICAGEN partnerships, which was also offset by the sale of our Vernalis business partway through the quarter. Adjusted diluted EPS for Q4 2020 was $1.62, or 128% higher than Q4 2019. For the full year 2020, we achieved $186.4 million in total revenue, which is an increase from $120.3 million in 2019, as we reported, or $106.1 million as adjusted for the sale of the Promacta royalty in Q1 2019. Including the Promacta adjustment, all three business lines increased year-over-year despite the challenging environment in the COVID-19 pandemic. Adjusted diluted EPS for 2020 was $4.55, or an increase of 47% over the $3.09 as reported in 2019, or an increase of 81% over the $2.52 as adjusted for the sale of Promacta. We finished the quarter with approximately $411 million of cash, cash equivalents, and short-term investments. Turning to financial guidance, we introduced 2021 guidance at our Analyst Day event in the fall of 2020. We're now increasing our guidance to reflect the recently announced positive trial results from Travere on their drugs, Barsentin. We now expect Travere to file for FDA approval in 2021, resulting in a $5.9 million net milestone to Ligand. Our top-line guidance for 2021 total revenue is now $291 million, up from $285 million previously. We expect an overall corporate gross margin for the year of approximately 75% to 80%, and we expect cash operating expenses for 2021 of $80 to $85 million. These revenue and expense components translate to full-year 2021 adjusted diluted EPS of approximately $6.15, which is up 35% from the 2020 adjusted diluted EPS of $4.55. Relating to sparsentin and longer-term projections, as we wait for more updates from Travere on their sparsentin program, we're pleased to see this program now increasing in potential to move toward the market to serve an important and underserved medical market. We will follow their guidance for timelines and regulatory updates, but given it could be potentially material new royalty stream for Ligand, we are providing our preliminary outlook for the program as we see it now. At this time, we estimate a potential launch in the second half of 2022. If that occurs, the first full year of sales would be in 2023. Evaluating third-party reports and considering our royalty rate, the initial projections we have for potential royalties to Ligand in 2023 is $10 to $20 million. Over the longer term, we see third-party analysts project sparse sentence sales by Travere of $500 million to $1 billion at peak. We will provide more information on our outlook as the program advances. With respect to quarterly pacing for 2021 throughout the year, we expect our royalty line will show the normal trends with a lower Q1 and then increasing each quarter through Q4. Our capital revenue and contract revenue are both expected to be spread relatively evenly across the year. Developments in the pandemic and with partner clinical success and timing may cause shifts from quarter to quarter, but we currently expect a relatively steady pacing on both fronts. Regarding strategic M&A as well as capital deployment, we continue to maintain an active evaluation of our M&A priorities as well as our capital deployment strategy overall. In Q4 2020, we deployed $24 million of capital. We used $19 million to repurchase our convertible bond and just under $5 million to repurchase our shares. During 2020, we also acquired Icogen, our ion channel technology platform, Phoenix, our protein expression technology platform, and Accela and Taurus, both of which augment our industry-leading OmniAb antibody discovery platform. As we look forward into 2021, we'll continue our focus on transactions that add new technology platforms to Ligand, add meaningful partner programs to our portfolio, and bring companies and technologies that complement our OmniApp platform. Finally, just before I turn the call over to Matt Fore, I direct our listeners to review our Q4 earnings press release issued earlier today and available on our website for a reconciliation of our adjusted financials to GAAP reported items. With that, I'll turn the call over to Matt for some comments on our portfolio and pipeline. Matt?
spk09: Thanks, Matt. Throughout 2020, Ligand's technologies have substantial positive impacts on global human health in highly visible and important ways. And now, here in 2021, our technologies and our partners that use them are poised for major events in the coming months and quarters. This morning, I'll briefly review some highlights and updates for each of our four core technologies. And I'd like to start with OmniAb and the suite of technologies within what we call our antibody discovery tech stack. We believe OmniAb is our most valuable platform technology as it continues to offer a unique combination of best-in-class advanced antibody discovery tools. And our partners who license the OmniAb technologies are supported by our team of respected world-class scientists with a track record of quickly discovering high-quality antibodies. We continue to innovate and invest in the OmniAb platform with internal R&D and technology development through collaborations with leading academic centers and through bolt-on acquisitions. Our partners value the work that we do, and we understand the importance of quickly and efficiently discovering fully human antibodies in a variety of formats. In 2020, we acquired and integrated new technologies and scientists into OmniAb from Accela and Taurus Biosciences. The Accela technology brought us an ultra-high resolution and high-speed cell screening technology to facilitate antibody recovery and selection from our animals. This technology leverages engineering advancements that originally came out of Stanford University and uses proprietary AI-based computing approaches. The Taurus acquisition brought Cal-based CDRH3 humanizing binding domain antibody technologies to the OmniApp suite. what we now refer to as Omnitor. Cow antibodies feature some of the longest CDR3s of any species with unique genetic and structural diversity that can enable binding to extremely challenging biological targets with application in therapeutics, diagnostics, and basic research. So our OmniAb technology now is differentiated by our use of leveraging our artificial intelligence or AI capabilities in our deep history of novel genetic engineering and biological intelligence, or BI, of our proprietary transgenic animals. The BI elements allow us to operate a highly efficient business model in serving our broad and expanding partner base. Our best-in-class technology stack is enabling our OmniApp business team to secure new license agreements with expanded economic terms. And in 2021, we will continue to add staff to further leverage and expand the OmniApp tech stack and serve our growing partnership base. Switching now to our patented Captisol formulation technology, 2020 was a transformational year for Captisol on many levels, as John generally described. And with globally recognized commercial products that use our Captisol technology, we've seen record growth of inbound interest in the technology, along with continued and growing commercial momentum. In Q4, we ship more Captisol to partners around the world than in any other quarter. We have a close partnership with Gilead for Veclari, And note Gilead's recent statement that approximately a million COVID-19 patients in the U.S. have been treated with Teclary. I note also that in the fourth quarter, we entered into a 10-year extension of our Captisol supply agreement with Gilead, and our team is proud of the role they have played and will continue to play in supporting this critically important therapy. Personally, I'm very proud of the work that the Captisol team has done and continues to do. We also entered into more CAPTASOL licensing deals in 2020 than in any other year, closing out the year with more than 160 new research license agreements and 13 clinical and commercial agreements, while also filling hundreds of inbound sample requests for CAPTASOL. We're confident that our CAPTASOL technology is positioned very well for continued success in 2021 and for many years to come. LIGAN maintains a broad and global patent portfolio for Captisol with more than 400 patents worldwide relating to the technology, including over 40 patents that are issued here in the United States, with the latest expiration date in 2033. We also have other patent applications covering methods of making Captisol that, if issued, extend to at least 2040. Beyond that, our Captisol partners greatly value our quality, our scale of manufacturing and our reproducibility, and our vast and growing safety databases for Capsosol. Switching gears now, our IcaGen team is doing a fantastic job managing and growing our ion channel technology partnerships, and they also had a very productive year in 2020. We closed out the year announcing a new deal with GlaxoSmithKline, where GSK gained access to our team's unique expertise in small molecule therapeutics, specifically targeting transmembrane proteins. This collaboration will utilize the Igagen ion channel-focused discovery technology to identify and develop inhibitors of a specific genetically validated molecular target relevant to a number of neurological diseases. As part of that deal, we received an upfront payment of $7 million and were eligible for milestones of more than $150 million in tiered royalties on net sales on any drug that is commercialized from the collaboration by GSK. GSK came to us because Libyan's unique model systems and depth of expertise will enable them to advance this drug discovery program with a higher probability of success, and may help deliver a new treatment option for patients suffering from neurological diseases. In addition to this new partnership with GSK, the Ion Channel team is also managing two partner programs with Roche, with more than $500 million in potential milestone payments associated with them, as well as potential tiered royalties. and also a valuable collaboration with the Cystic Fibrosis Foundation. And now switching to our Phoenix protein expression business. The acquisition of Phoenix closed four months ago and is now fully integrated into Ligand, as John described. For those who may be new to the technology, the Phoenix expression technology platform leverages proprietary strains of pseudomonas fluorescens, and it is unique and highly valuable to the industry because of its ability to express complex antibody derivatives and other engineered protein modalities. Simply put, it's a technology that makes manufacturing of complex drugs possible. These complex drugs have the potential for greater specificity, improved side effect profiles, and ultimately successful therapeutic outcomes, and these characteristics make them an area of a substantial amount of current biopharmaceutical development focus in the industry. We leverage a rich history with the platform with extremely high throughput screening technologies and proprietary computer-driven automation to get robust production streams very quickly for our partners. We believe that our CMC development engine and state-of-the-art analytical capabilities position us very well to be a leader in this space. The protein expression technology delivers significant competitive advantages to our partners, including the speed with which they can enter into clinical production, increased production quality, and lower cost of goods. Our platform has a success rate of more than 80% in producing proteins that had failed in traditional systems, like those based on E. coli or traditional CHO cells. Importantly, this technology has been further validated from a regulatory standpoint with the approval of teriparatide injection in both the U.S. and Europe, with two exciting late-stage assets with global industry-leading partners that have now submitted for approvals. Specifically, Merck submitted applications to the FDA and the EMEA for approvals of V114, which is their investigational 15-valent pneumococcal conjugate vaccine that uses the Phoenix protein expression technology. The applications include positive data from multiple Phase II and Phase III clinical studies with V114. And earlier this month, the FDA accepted for review the BLA for V114, thereby triggering a milestone payment of $1.5 million to Ligand. In December, Jazz Pharmaceuticals initiated the submission of a BLA to the FDA seeking market approval for JZP458. This drug is a recombinant erwinia asparaginase produced in our expression platform. which alleviated supply challenges and resulted in a robust process showing manufacturing consistency and efficiency. Going forward, we see a growth trajectory for the protein expression business that can drive revenue and yield a variety of different types of deals with durable downstream economics to log in. We see clear paths and opportunities for partner development deals, for traditional asset outlicensing deals, for assets that are part of the legacy of R&D pipeline associated with the portfolio and platform, and for what we term platform pairing deals, where partners come to us to leverage our technology in combination with their own pieces of technology. And with that, I'll turn the call back over to the operator for questions. Operator?
spk01: At this time, if you would like to ask a question, please press star, then the number one on your telephone keypad. We'll pause for just a moment to compile the Q&A roster. Your first question comes from the line of Joe Pingenis with HC Wainwright.
spk05: Hey, everyone. Good morning. Thanks for taking the question, and congratulations on your real continued progress here. So three things, and the first one is really a comment or congratulations on Sparcentan. I guess, you know, you're really coming to the tail end here of a very strong developmental path and really talks to your early strategic moves when you bought Pharmacopia and all the work that they did, including randomized Phase II data that allowed you to leverage much higher economics for, as you said, a drug, you know, based on estimates that are out there, $500 to $1 billion in peak sales. So congratulations to seeing the potential endgame here for that. So, I guess my two questions are the following. First, with remdesivir, now that we have, you know, some general views about infection rates and what have you, you know, do you feel you're hitting a bit of steady-state remdesivir needs for the Captisol platform? And how do you see sort of the one- or two-year plan around that for remdesivir?
spk09: Yeah, thanks, Joe. This is Matt. I can comment there. Obviously, we've got the caposol guidance out there for the year, for 2021. As John was describing in his comments, there's a growing view, and I think this is, you talk to experts in the field, that COVID-19 will be an endemic disease. Obviously, Gilead has invested substantially in randomized double-blind control trials for Veclary and shown really stellar data in terms of improving recovery times, et cetera. We entered into a new 10-year deal with Gilead supply deal last year near the end of the year. A 10-year relationship gives us a binding visibility, a rolling forecast throughout the year, and we feel very good about our outlook for the program. As you look now, there's still, obviously, a high level of hospitalization. Juliette's quoted that... Approximately one in two patients hospitalized in the U.S. are treated with Veclary, and we continue to see, obviously, a high demand for Captisol. Beyond that, Gilead continues to invest over 40 interventional or observational studies for Veclary are ongoing. continuing to look at new settings as well, outpatient settings, new formulations, sub-Q, inhaled formulations, all of which utilize capsaicin as well. So hopefully that gives you a little more color and detail there. There may be others that Matt or John want to add, but I appreciate it.
spk05: No, that certainly does. Thank you for that. And then my last question really is a little higher level with regard to your underlying business here, and I want to focus on OmniApp. Been focusing for quite some time in my discussions with investors that OmniApp really represents a business unto itself. And you did brought in multiple tech platforms or what have you. So I guess my question is two-pronged. First, can you describe your overall inbounds for OmniApp across the different tech stack that you described and the different species and platforms that you have under OmniApp? Are there Sort of, you know, are they across the board? Are certain technologies favored more than others? And then, so I'll leave that as part one.
spk08: Yeah, Joe, thanks. I'll make just a general comment, and then Matt can get into some more of the details. So we acquired the platform five years ago, and every year we've invested more in staff and computers and also other tuck-in acquisitions. What's fascinating, and we know this in the industry, success, clinical research discovery success breeds more business. And early on, the first year or two of our operations, we had a good record of dealmaking. We were seeing more discovery success, preclinical and clinical starts, and the word got around the industry, and that drove more deals. The last 12 to 18 months, what is becoming very clear is that our further investment, Abinicio, Accela, Taurus, we have an inside view into what the industry needs, and we are bolting on other adjacent technologies that is really enhancing this platform. Industry insiders, industry players know this and they want it, and that is also further driving dealmaking. So we've always had best in class since we've owned it, but our – position and leadership prominence is only building. Matt, perhaps you want to comment more on the technical side in terms of our BI.
spk09: Yeah. Well, obviously, we've got a rich history of continued innovation in genetic engineering in animals, and that's something that I'll say is really at the heart and a bedrock foundational element of the Omnia technology. But we've also... shown a commitment to technology development around the BI, the biological intelligence of our animals themselves, right? So sorting technologies, things like the Accela acquisition that allow us to find lead antibodies even faster out of our animals, obviously speed and depth of analysis matter a lot to our partners, and we continue to add on to that core of biological intelligence An analogy some partners say is that finding the right antibody after you get an antibody response is like finding perhaps a needle in a haystack. You want to find that best antibody that has the biological qualities that you're looking for, hits the target in a certain way, has the manufacturability and other durability elements you want to see. It can be like finding a needle in a haystack, and what some of our partners have said is the biological intelligence puts more and more needles near the top of that haystack so that you can find them more quickly, you get the highest quality antibody, and you can move it into development. And as John was generally referencing, when you have partners like Janssen and Merck, Genentech, GenMab, all of whom have had successes finding high-quality antibodies and are talking about those at scientific and medical conferences, that really begets more and more inbound interest around the technology.
spk05: That is really, really helpful, guys. And then just part B of that is just, I guess, and I'm not sure your comfort level about describing or discussing the competitive landscape, but it really comes down to the numbers game. And I'm talking strictly factual points here. When you look at certain other companies and recent entrance to the public markets in the antibody space that are garnering significantly higher you know, valuations just for an antibody platform, you just, based on my looks here, you have, it appears to have, you have much better BI with regard to the number of species and tech platforms, numbers of partnerships, and just greater numbers across the board. I don't know how much you're willing to discuss the landscape.
spk08: Yeah, Joe, thanks. It's fascinating. Ligand, a diverse company, a multitude of technology platforms, we really serve a range of discovery needs that the industry requires. OmniApp is one part of our business. Investors ask questions and obviously do analysis across the board. But when you specifically focus on our OmniApp platform, the antibody business, it's very well positioned against these other industry players. Some are still private. Of course, there's not as much publicly available information. We're seeing a growing number of companies are going public. We're seeing headlines around M&A. And what's fascinating is that in antibodies, and we're talking about human therapeutics, okay, so the medical category is the same, right, mostly oncology-based targets, immunology. The medical category is the same, the clinical, the regulatory path, And in general, the target customers, the partners are the same as well. So we're all participating in the same market. So when you start to evaluate or compare these companies, you can look at the number of partners, the number of programs in discovery stage or in the clinic. You can look at the economics. And across each one of these, we are very, very well positioned. We bought OmniApp, we had about 15 partners five years ago. Today we have over 50. The number of programs is well into the hundreds now. Many are still early discovery stage, but our success or hit rate is very high. We now have a very, very substantial calendar of partner clinical events, over 8,000 patients being treated in a multitude of trials. And notably, a lot of these other platforms are are targeting really the first FDA approvals or major regulatory approvals out four or five or six years. For ligand it's in 2021, it's this year. So the number of programs is high, the number of partners is high, the later stage nature of development, and ultimately the back end economics for these companies are very similar. The pricing, the milestone payments, the back end royalties and so on. We feel very good about the business, and I think there's going to be just heightened interest in profiling around this operations as 2021 progresses.
spk05: Appreciate all the feedback, and thank you guys for indulging me.
spk01: Your next question comes from the line of Balaji Prasad with Barclays. And Balaji, your line is open. If you're on mute, please unmute your line.
spk00: All right, morning. Thanks for taking the questions. John just jumped on the call a few minutes ago. So a couple of questions from me. Have you started seeing auto flows materially increase from the generic companies who have been licensed Remdesivir 1? Secondly, could you provide us an update on the therapeutic equivalent status for teriparatide And lastly, is it fair to assume that the guidance increase in 2021 is all linked to the milestone payment? And since the last analyst day, are there any other programs where you have better visibility on milestones in 2021? Thank you.
spk09: Thanks, Balaji. This is Matt. I can take the first couple of questions. Obviously, as we've disclosed previously, we are supplying Captisol to the members of Gilead's manufacturing consortium. They have a global consortium to supply over 127 countries around the world, and we are and continue to supply those partners. So that continues to be a vibrant part of the Captisol business as well. You asked about the teriparatide injection and Alvagen's work towards therapeutic equivalence. I can report that Alvagen filed positive human factors data, and that was submitted to the FDA in January. So that work has been completed. The reports were submitted to the FDA in January, so those are now under review at the FDA.
spk06: Balaji, I think your last question was about milestones and visibility on milestones. I think in the past we've talked to investors about our milestones and buckets of what we expect to hit and then some upside numbers. We haven't quantified the upside this year, but obviously the Trevier milestone that we mentioned was in our upside bucket this year. And we do think that there's some other milestones that are in the upside bucket that may hit this year, but we continue to think that the current guidance reflects an average number of those milestones sort of properly risk-adjusted hitting this year, and we can achieve those numbers. But there still does remain some upside if some of these events come in timing-wise or more more frequently than we might expect otherwise. So there's definitely still some upside on the milestone side.
spk00: That's helpful, John. Thanks, Matt.
spk01: And again, if you would like to ask a question, please press star, then the number one on your telephone keypad. Again, that is star, then the number one. Your next question comes from the line of Matt Height with Craig Hallam Capital.
spk03: Good morning. Congratulations on the strong year, guys. A couple questions on OmniApp first. You know, there was a little bit of change in wording in the press release this morning, adding the AI and BI components. And I know, John, you touched on them a little bit, but I'm just curious, are these recent additions to the platform, or is it customers have been asking more about those attributes, and it's something that you feel like now is the time to kind of highlight them a little bit more?
spk08: Yeah, nothing new. The AI, the artificial intelligence, has become more prominent the last 12 months, particularly with our acquisition of Accela and Avanicia. When we look at our methods for using antigens for the discovery work, it's a heavy computer-driven process. um, operation and, um, and our customers know it and, and it's how we position our services. Um, for, uh, investors, what we're finding is that there's an increasing audience that really understands the high value of AI. So, um, so that, that is, is an evolution. The BI, uh, the biological intelligence, uh, really our animal platform, it is, it is, uh, best in class and, frankly, the only in class that has this complement of a multitude of species, the mouse, the rat, the chicken, and now with Omnitore. And that is coupled with the AI. So it's been a part of our business for the last five years, ever since we've acquired OmniApp, but it's expanded with these additional tuck-in acquisitions.
spk03: Understood. All right. Thank you. And then sticking with OmniAbit, so I think Seastone and Gloria are probably the likely first approvals or potential approvals to come out of that pipeline. Gloria, I think, is the furthest along. Maybe walk through the process there in China as far as when could we hear something on Gloria and what is the process once the Chinese agency approves the drug and Maybe walk through one that actually might start to translate into royalties.
spk09: Yeah, Matt. So you're right. Gloria and Seastone are the two most advanced OmniApp partners with NDAs under review right now in China. Both are expected to be approved this year. based on the filing dates. And obviously, generally, there's a period also that, you know, a lead up to launch, et cetera. But we do expect both of those are potential approvals this year. Those are the most advanced approvals. on the app programs. So hard to give exact, you know, details on, you know, precise rollout timing post approvals. The partners have basically just stated that they expect the approvals this year. Based on the filing dates and the announcements around the filings, we'd expect Gloria to be a little sooner than Seastone. So in the earlier part of the year. but that's something we'll continue to monitor, and the partners have obviously done very good work, stellar clinical data, and really have been ahead of schedule all along with both of those programs.
spk03: That's great. And then the last one for me regarding Iohexol, you're going to be kicking off the pivotal trial this quarter. How quickly – Maybe some details on that trial. I think you went over a little bit of it on your analyst tape, but just as a reminder, the details, how quickly, how many patients. And as you look at coming out of that trial, I would imagine that you're looking to potentially partner. But is there a scenario where, given that this isn't necessarily a drug, that this is an imaging agent, is there a scenario where you would just take this on yourselves, maybe hire a sales force? and bring this to market yourselves. Anything, any color there would be helpful. Thank you.
spk09: Yeah, Matt, I'll comment on the clinical trial, and then John or Matt may want to comment on the kind of downstream approaches as well. But first, starting off with the product, we're initiating a pivotal trial for Capsol-enabled iohexol, It will participate in what is a $1.5 billion existing market, the contrast agent market here in the U.S. The trial itself is a trial designed to demonstrate reduction in the incidence of contrast-induced acute kidney injury, or what's called CIAKI, as well as equivalents of image quality following the administration of our drug, CEI-L-Haxol, as it compares to GE's OmniPIC. The trial itself is a 540-subject clinical trial. As you said, we're gearing up to start that this quarter. It's an adaptive design. It's a randomized, multicenter, double-blind, parallel group trial. uh, in patients with impaired renal function that are undergoing invasive, uh, coronary angiography. Um, so, uh, there will be, uh, a, a, a pre-specified interim analysis, um, looking at rate of, uh, CI, AKI, um, that'll be performed after about 60% cruel. Uh, so we expect the trial itself to take a total, uh, of about two years that, that, um, that pre-specified interim analysis probably in the timeframe of about 10 to 12 months into the trial. So with a significant reduction in rate of C-I-A-K-I and a demonstration of image equivalence, that would potentially allow for a 505B2 path approval of CEIO-HEXAL, but with a label that would or could include C-I-A-K-I the reduction in risk of CI AKI. So a differentiated product with a kind of a clean and streamlined development path.
spk03: That's great. Thank you very much.
spk01: Your next question comes from the line of Scott Henry with Roth Capital.
spk07: Thank you. Good morning, and congratulations on strong momentum really across the whole business. I just had a couple questions. First, on Captisol, I assume we're still at $200 million revenue guidance for 2021. Could you talk about how we should think about the cadence of the quarters for Captisol? It's obviously strong in Q4. thinking about this year?
spk06: Yeah, sure. Thanks, Scott. I think, as folks recall, we gave an estimate for Q1 of $45 million back at our analyst day. And then on this call today, I mentioned that I think the capticel number should be relatively spread evenly across the year. Obviously, the pandemic has has resulted in significant case increase in the fall, late fall, winter, and then cases are starting to come down generally across the U.S. and the globe. But from a production standpoint, there's a little bit longer lead time. So we still see the same 200, as you indicated, and we still see a relatively even spread across the four quarters based on kind of current forecasts.
spk07: Okay, great. Thank you. That's helpful. Second question, obviously, there's a lot going on in the pipeline, and there's a lot of events in 2021. The question is, what would you view as the three to five largest levers, catalysts that would be the primary drivers ones for investors to focus on. I don't know if you have any quick thoughts on that, but I thought it would be interesting.
spk08: Scott, thanks for the question. At the start of my call, I kind of framed four main factors defining our value. To break them down, those four are really an easy outline to work with to answer your question. OmniAB The platform is doing very, very well. And so looking for new license agreements, major late-stage data, and BLA approvals and launches. So it's a list of stuff, but it's going to, we believe, deliver our first commercial revenue, royalty-based revenue this year. There's going to be more breakthrough data on some really important market-defining drugs. And what we've done the last 18 months, I think it's going to be, in terms of acquisitions around that platform, it's going to be more obvious for investors. It's clear to our partners. So that's one factor. Our acquisitions, we're only three to nine months in on two major acquisitions, Phoenix and IcaGen. Both are well-integrated right now. we did one deal with GSK, but, uh, this year, I think we're going to really, really start to, uh, bear fruit, uh, looking at not only revenue earnings contribution, but also, uh, substantial new deal-making around those and, uh, you know, quality additions to our portfolio, but I believe it's also going to just reinforce our acumen at, at good M&A. On Veclary, um, The pandemic continues. I think the leadership that the world pharma companies are providing is giving us hope that we'll get this pandemic under control. But our partnership with Gilead for Veclary is, frankly, going to be still a major driver of our performance this year. And then finally, just generally, what we're seeing with the P&L, the fourth thing I called out was just our financial performance. I started on, we're describing licensing and operating performance and acquisition record. But the financial performance, it's high revenue growth. So the top line, we believe, is going to look very, very compelling. Attracted margins, disciplined spending, good margins. And then with our significant share repurchase, two years ago we had 23 million shares outstanding. Today we have about $17 million. So that lean share base is going to deliver more earnings and cash flow per share. So that's going to be much more focused this year in what investors can evaluate.
spk07: Okay, great. Thank you for the color. Final question, and I don't know that you will answer it, but I think in the prepared remarks you said that the average price of the share buyback was $145, if I heard correctly. Could you give a range, out of curiosity, of the share buybacks?
spk06: Thanks, Scott. No, the actual average share price was $104, $104 per share. So, yeah, that's about, in total... Since November of 2018, we've bought back, as John just referenced, over 6 million shares or so total, and average price of about 100 in the low 100s, 104 or so.
spk07: Okay, that makes a lot more sense. That number seemed off to me. That's why I asked the question. Thank you for that clarification. Sure.
spk01: And we have time for one further question. Your last question comes from the line of Dana Flanders with Guggenheim.
spk04: Great. Thank you for the question. I just have one for Matt. And related to just cap structure and priorities for cash flow on a go-forward basis, obviously the cash balance has moved a bit lower just given your activity on the M&A front and share buybacks. But you will be generating cash flow significant amount of cash flow next year. How are you just thinking about the cash available for M&A over the next 12 to 24 months? And given, you know, recent share price performance, how are you weighing, you know, some of the capital deployment opportunities you have, whether it be buyback or debt repurchases or M&A? Thank you.
spk06: Yeah, thanks, Dana. As folks know, we have about $500 million of face value of the debt still outstanding. And as I mentioned on these numbers today and we put in the press release, we have about $411 million of cash on the balance sheet. If we project forward to maturity of the convert, we have plenty of cash to just repay the convert as is the face value or the principal value of the convert. So From our standpoint, we have excess cash to the tune of $100 or $200 million at least to go out and do M&A, even if we did not refinance the convert or otherwise. While we still think our share price is significantly undervalued, we obviously have the opportunity to refinance the convert if we so chose. So from a strategic standpoint, capital standpoint, we have the cash to do whatever we'd like to do. I mentioned in my prepared remarks, though, that I think our focus has really been on a multi-pronged approach of large platform M&A as well as capital deployment or capital return to shareholders. We'll continue to evaluate all that as we go forward, but in the next three to six months or so, I think we're in a mode where we're working through and making sure that all the platforms are running as optimally as they can, so fully integrating and getting everything up to our standards. We're nearly there, but I think it's appropriate for us to digest that a bit. It doesn't mean we won't keep looking, and M&A takes a long time, and it's very opportunistic. by no means are we closed for business, but from a priority standpoint, I think we'll, as I said, look for technology acquisitions that augment the OmniApp business, continue our lead in that business. We'll look for new technology platforms, and we'll look to add major pipeline royalties that will be meaningful to Ligand. So Those three on the M&A front with a continued focus of evaluating share return or capital return as well as M&A.
spk04: Thank you.
spk06: Great. Thanks, Dana.
spk01: And I will now turn the call back over to the speakers for any closing remarks.
spk08: Yeah, thank you. Really appreciate people's turnout today and questions. We're pleased to have 2020 behind us. A year of great opportunity and some challenges, but the team answered the call, and we're really pleased with our performance. We're set up for 2021. We have invites to some virtual conferences. We'll be on the road, and we look forward to continuing to report on our progress. Thank you for joining our call.
spk01: This concludes today's conference call you may now disconnect.
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