Ligand Pharmaceuticals Inc Q3 FY2022 Earnings Call

Good afternoon. My name is Vinesin, and I will be your conference operator today. I would like to welcome everyone to the Ligand Pharmaceuticals Third Quarter 2022 Earnings Conference Call. I would now like to turn the conference over to Simon Latimer, Head of Investor Relations. Please go ahead.

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

Simon, thank you. Good afternoon. Thank you for joining Ligand's Third Quarter 2022 Financial Results Conference Call. I'll open the call with some remarks about our recent major strategic and financial transaction. We closed the OmniAb spinout on November 1st, just one week ago today. In the parlance of radio, you are putting into the same station. This is Ligand Pharmaceuticals and our ticker symbol is still LGND. But things have changed. Compared with a week ago, Ligand is a streamlined company with a different stock price and a $1 billion valuation. We have about half the number of employees as before and a reconstituted management team and Board. However, our core business model is unchanged. We are profitable and cash flow positive, and our outlook is very promising. Our business is to provide drug research tools and our financial growth is primarily fueled by sharing in product revenue in the form of royalties on pharmaceutical products. Global sales of our major royalty-bearing assets are growing and we have an economic interest in a large portfolio of late-stage assets that are on the cusp of potential major data readouts or regulatory determinations. The potential and promise for what Ligand has to offer investors is as compelling as ever. As for OmniAb, as of last month, this was our wholly owned antibody drug discovery business unit. Now it is operating as a completely separate public company. I'm very proud of what we achieved at Ligand over the past 7 years to build the OmniAb business, and we are pleased to see the spinout completed. The spinout successfully achieved the objectives that we have talked about for the past 12 months, and the company is very well positioned with its partners to be a major industry player for years to come. The spinout efficiently separated the R&D business into a fully functioning, well-capitalized company. The company post-spin cash position is about $95 million with expectations for $35 million of additional capital from partner milestone payments due upon the anticipated launch of teclistamab in the coming months. Annual revenue is projected to grow based on its existing portfolio and recently approved royalty-backed programs. OmniAb has a major new strategic investor with Avista Healthcare, owning about 15% of the company. And importantly, OmniAb is reconfigured with the new Board of Directors and management team with deep domain expertise and a dedicated focus on driving the best in antibody drug discovery. A quick comment on an administrative matter. The spinout resulted in Ligand stock being split. All Ligand shareholders at the time of the split retained the exact same number of shares in Ligand, but Ligand investors, at the time of the spin out, also received shares in the new company called OmniAb. Specifically, for every 1 share of Ligand, shareholders received about 4.9 shares of OmniAb. This might seem very basic, but it is worth pointing out to all shareholders, especially smaller shareholders, to look at your brokerage statement as you now have shares in a whole new company to go along with your Ligand shares. In this moment of transition, I want to express thanks to my former colleagues, in particular, Matt Foehr and Charles Berkman, for the extraordinary contributions they made to Ligand over the past decade and longer, helping build Ligand along the way into the fine company it is today. They are at the core of the new executive leadership team at OmniAb, and I wish them all continued success running that company. Of course, I also want to say it is a pleasure to be working with the new leadership team here at Ligand. Matt Korenberg, who you all know, has stepped up to serve as President and COO. Tavo Espinoza has been with us for over 6 years and has assumed the role of CFO, and Andrew Reardon has recently joined our team as our new Chief Legal Officer. I'm delighted to be working with this tremendous group of seasoned professionals and I know each of them shares my enthusiasm for what the future holds for Ligand. Now with this transition, we are eager to get out to meet with shareholders in person to update them on the newly reconfigured business. In addition to attending investor conferences over the next 2 weeks, we will be hosting an analyst and investor event in New York City in the middle of December. Currently, we are targeting December 13, and the specific information for that event will be announced within the next two weeks. We encourage investors to consider joining us in person, or if that is not possible, to log in virtually. With that, I will now turn the call over to Tavo for a review of our financial performance.

Thanks, John. I'm pleased to be speaking with all of you today in my new role as Ligand's CFO. Before I get into the financial review, I'll give a quick background into myself. As John mentioned, I've been with the company for about six years. I'm a certified public accountant licensed in California. I started my career with PricewaterhouseCoopers and have over 20 years of experience overseeing and leading finance and accounting functions for a number of companies, including six years with Intuit, the maker of TurboTax and QuickBooks, and 7 years with Illumina, the genetic sequencing tools leader. I'm excited to be joining the executive team here at Ligand, and I look forward to continuing the company's long-standing commitment to financial discipline and transparency as most recently exemplified by Matt Korenberg. Today, I'll review our quarterly financial results and update our 2022 financial guidance. The third quarter of 2022 was a strong quarter financially with particularly impressive performance in the royalty revenue line. Total revenues for the quarter were $66.1 million, royalty revenue increased 27% to $19.8 million from $15.6 million a year ago. This growth was driven by strength in Amgen's Kyprolis, which once again posted record quarterly revenue. Teriparatide and Rylaze also contributed significantly to the growth of royalty revenue. During the quarter, we recorded $4.1 million in royalty revenue from teriparatide and $2.1 million from Rylaze, both exceeding our expectations. We expect the launch of additional competitors for branded teriparatide to come within the next six months, but it's hard to predict exactly when. That will impact revenue going forward. However, the competition has not yet materialized, and as a result, the product is performing better than we had anticipated. Total Captisol sales were $35.9 million for the quarter versus $35.1 million a year ago. Core Captisol sales were $3.6 million this quarter versus $5.4 million last year, with the difference due to the timing of customer orders. Captisol sales related to COVID-19 were $32.4 million during the quarter, compared to $29.7 million a year ago. Contract revenue in Q3 2022 was $10.3 million. This compares to last year's third quarter of $14.1 million. This difference in contract revenue is generally due to the timing of partner events and related milestone payments. GAAP net income for the quarter was $4.4 million or $0.02 per diluted share, and this compares with net income of $13.7 million or $0.80 per diluted share in the prior year quarter. The lower GAAP net income is largely driven by additional OmniAb expenses as that business scaled up in preparation for the spin-off John just described. Also, in the prior year quarter, there was a positive $3.8 million non-cash valuation adjustment and other operating income related to eliminating the remaining Phoenix CVR liability. Adjusted diluted EPS for the third quarter of 2022 was $1.31, and this compares with $1.58 in the third quarter of 2021. Excluding COVID-related Captisol sales, our adjusted diluted EPS for Q3 2022 was $0.41 compared with $0.64 in Q3 2021. During the quarter, we repurchased $38.6 million in principal of our 2023 convertible notes at a 2.6 discount to par, and we have approximately $77 million in remaining convertible debt outstanding, which matures in May of 2023. When the bonds mature, we will repay them in cash. As of September 30, 2022, Ligand had cash, cash equivalents and short-term investments of $121.4 million. Turning now to guidance. Today, we are raising our 2022 revenue and earnings outlook from continuing operations. Given the spin-off of OmniAb, from here forward, we'll be providing guidance for Ligand from continuing operations, which excludes OmniAb revenue and expenses. We now forecast 2022 royalties to be in the range of $66 million to $69 million, up from our previous outlook of $61 million to $65 million. This increase is driven mostly by upside from teriparatide and Kyprolis. As I mentioned, Kyprolis is doing very well and is hitting all-time highs for quarterly revenue. Teriparatide is seeing strong commercial trends because additional competition has not yet entered the market. We're now assuming that other competition will enter the market in early 2023. Should that be the case, we anticipate sales for teriparatide next year will be lower than in 2022. We now expect Captisol material sales to be about $100 million, up from our previous outlook of $55 million to $60 million. We expect $15 million of core Captisol sales and the balance to be Captisol sales for COVID. We expect contract revenue to be in the range of $18 million to $20 million, and this is the revenue line most impacted by the OmniAb spin-off. These new revenue components result in total revenue from continuing operations of $184 million to $189 million. For the continuing business, excluding COVID-related Captisol, we now expect revenue to be $99 million to $104 million, up from $97 million to $104 million previously, and adjusted diluted EPS to be $2.05 to $2.20, up from $1.80 to $2.05 previously. We estimate 2022 earnings from COVID-related Captisol to be about $2.25 per diluted share. Therefore, for consolidated reporting from continuing operations for the year, our updated guidance is for adjusted diluted EPS of $4.30 to $4.45. As a reminder, I'd like to direct listeners to our third quarter earnings press release issued earlier today and available on our website for a reconciliation of our adjusted financial results to the GAAP results I talked about today. I'll turn the call over to Matt to provide an update on the business.

Thanks, Tavo. I'll echo John's earlier comments and say that I'm also very excited to have the OmniAb spin-off complete, and I look forward to tracking our former colleagues’ success as an independent public company. Today, I'll be providing some brief comments on a few of our key commercial and clinical programs. I'll begin on the commercial side with two programs that are driving a good portion of our 2022 royalty revenue. Kyprolis and EVOMELA have both been on the market for many years and both have significant remaining runway. We expect Kyprolis, in particular, to drive growth on the royalty line for the next five years. Kyprolis is marketed by Amgen in the majority of the countries around the world and by Ono in Japan, and Beijing in China. This is a key drug for treating multiple myeloma that's on track to exceed $1.25 billion in sales in 2022 and generate about $30 million in royalty revenue for Ligand. In addition to Kyprolis and EVOMELA, teriparatide, which Tavo already commented on, and Rylaze have been significant contributors to Ligand's top line this year. Jazz markets Rylaze for the treatment of acute lymphoblastic leukemia or lymphoblastic lymphoma. Rylaze is a recombinant Erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of children and adults with ALL or LBL who are hypersensitive to asparaginase products derived from E. coli. After launching Rylaze in mid-2021, Jazz quickly ramped up commercialization. In Q2 of 2022, Rylaze reached $73 million in sales. Jazz reports Q3 later this week, and we look forward to their commercial report as well as an update on their efforts to expand the label for Rylaze in the U.S. and seek regulatory approvals in other markets. Turning now to some key pipeline programs. I'd like to touch on sparsentan and ensifentrine and lasofoxafine. Sparsentan is a key pipeline program for Ligand. We will earn a 9% royalty on sales should the drug be approved and commercialized, and this should be a significant driver of growth for our royalties. Javier recently announced that the previously assigned PDUFA target action date for its NDA under Subpart H for accelerated approval of sparsentan for the treatment of IgA nephropathy of November 17, 2022, was extended by three months and the new PDUFA date is now February 17, 2023. Travere subsequently announced that the EMA had accepted for review the conditional marketing authorization for sparsentan for IgA nephropathy in Europe with a review decision expected in the second half of 2023. Corona recently announced positive top line results from its Phase III ENHANCE II trial evaluating ensifentrine for treatment of COPD. The trial successfully met its primary and secondary endpoints evaluating lung function and significantly reduce the rate and risk of COPD exacerbations. Ensifentrine was well tolerated with safety results similar to placebo. Bronto subsequently announced additional analysis, demonstrating ensifentrine reduced exacerbation rates across all subgroups in the trial. Ligand earns a low single-digit royalty on sales should the drug be approved and commercialized. COPD is a multibillion-dollar category, and ensifentrine is expected to be the first new entrant in many years. Sermonix announced results of its Elan 1 Phase II study of lasofoxifene versus fulvestrant in postmenopausal women with locally advanced or metastatic estrogen receptor positive HER2-negative breast cancer and an ESR1 mutation. Median progression-free survival was 6.04 months for lasofoxifene versus 4.04 months for fulvestrant. Objective response rate was 13.2% for lasofoxifene versus 2.9% for fulvestrant. With 1 complete response and 4 partial responses in the lasofoxifene arm, and no complete responses and only 1 partial response in the fulvestrant arm. While the study was not powered for statistical significance, all endpoints numerically favored lasofoxifene. Ligand's entitled to a tiered royalty of 6% to 10% on sales of lasofoxifene. Finally, at our upcoming Analyst Day in December, among other updates, I look forward to providing investors with a deep dive on Ligand's business profile following the separation as well as our strategic agenda moving forward. And with that, I'll turn the call back over to the operator for additional questions.

And your first question is from Joe Pantginis with HC Wainwright. Please go ahead.

Hey guys, good afternoon. Thanks for taking the question. And good luck on the 'new path' even though you're continuing as usual. So best of luck. So I guess I just wanted to check in with regard to the bonds first. So if I heard you correctly, it was about $77 million left and you said you have the intention to pay for it with cash. So I just wanted to confirm that you still have the option to pay with shares as well because while you have increasing cash flow from royalties and everything else, I'm curious to see how you view it impacting your overall business strategy and your current shopping list. Thanks a lot.

Hey Joe, good to hear from you. The bonds, when we originally put them in place, we pledged to repay the principal in cash at all times. So if the bonds were in the money, then the part that was in the money would be shares, but the principal would still have been in cash. We could always, in theory, negotiate to change that, but the plan right now is to repay the principal in cash.

And so the impact on the cash balance with regard to like the overall business strategy of the company, which I guess was part of my next question as the segue to say, the biotech markets continue to be under pressure, even though there's some rebound. So as you're looking at potential opportunities in addition to what you are generating through Pelican, etc., how would that impact any decisions you're making over the next, say, 6 to 12 months for cash resources?

Yes. Yes, it makes sense. Of course, yes, you alluded to our strategic agenda going forward, which we'll dive into a lot more at the Analyst Day in December. But you alluded to it as well in your question that said, it's a lot more of what we've been doing historically. So our M&A and strategic agenda has ranged from $10 million to $20 million acquisitions on the low end, up to several hundred million with Phoenix and some of the other acquisitions we've made over time. We'll continue to look for acquisitions across that spectrum. And I think it's fair to say that at the time of the bonds being repaid, we'll have at least $50 million of cash on the balance sheet, but we'll have a clean balance sheet from a debt perspective at that standpoint and the ability to use equity. So between equity, debt or the cash on the balance sheet, I think we'd still be able to execute across that whole size spectrum with obviously, the near-term focus being a little bit more on obtainable things until we finance one way or the other, either equity or debt if we were going to do something larger.

Got it. Thanks, very good to know. Thanks a lot, guys, and good luck.

Your next question is from the line of Larry Solow with CJS Securities. Please go ahead.

It's Pete Lucas for Larry. Just wondering, I know you touched on it in the prepared remarks a little. But if you could give us a little more color on the progress at Pelican Rylaze. I think you mentioned expanding the label in the U.S. and then moving into other countries. I think it reached about $250 million run rate in the U.S. Do you think that could be $500 million on a global scale eventually? And with the VAXNEUVANCE from Merck, can this compete head-to-head with Pfizer and still talk of that being a $1 billion annual vaccine?

Thank you, Pete, for the questions. Regarding Rylaze, our partner Jazz markets this product, and we do not have any private information beyond what they disclose. We're relying on the same third-party research analysts' estimates that you mentioned. Currently, these estimates suggest Rylaze sales will exceed $270 million this year. Last quarter, the sales were $73 million, as noted in my earlier remarks. We'll observe how this quarter unfolds in Q3, but it appears they are on track to reach that $270 million target. You mentioned the predecessor product to Rylaze, which historically generated around $200 million globally. In recent years before the transition, it was closer to $175 million. Jazz has already surpassed that figure with their current U.S. approval. They're making great strides with the product, looking to expand the label in the U.S. for various dosing regimens and patient populations, and pursuing opportunities in additional regions. I have not seen estimates approaching the $500 million mark, but it’s difficult to predict based on the product's current performance and the marketing efforts. We're very pleased with their progress thus far. As for Merck's VAXNEUVANCE, this pneumococcal vaccine participates in a market valued over $8 billion globally. Pfizer's Prevnar made around $5.3 billion last year. Merck's VAXNEUVANCE launched earlier this year and is the first to gain pediatric approval for this next generation of pneumococcal vaccines. They are starting to engage in the pediatric market now. Like with Jazz and Rylaze, we do not have access to Merck's private sales information, but several third-party analysts are forecasting sales for VAXNEUVANCE to exceed $1 billion, and we look forward to their advancements toward that aim.

Very helpful. And just sticking with Pelican, anything that we should know or that you can comment on with regard to the pipeline of earlier-stage compounds at Pelican and how has that progressed over the last couple of years?

Yes, we acquired the business in late 2020, so we're approaching or have just reached the two-year mark. The business has been performing exceptionally well. If we separate the business into the four or five late-stage programs that are nearing market launch or approval, those products are thriving. This includes teriparatide, Rylaze, VAXNEUVANCE, and Pneumosil from the Serum Institute of India. All of these products, along with another one from the Serum Institute, are making significant progress and contributing to our revenue. The other half of the business involves partner work in the earlier-stage pipeline. The team has made several new licensing deals this year and is progressing well. Many of these programs remain in the earlier stages, both those that were in place at the time of acquisition and those that have been partnered since then. We are optimistic about the long-term growth and addition from these programs, although they are still in a somewhat earlier stage.

Very helpful, thanks. I’ll jump back in the queue.

Your next question is from the line of Matt Hewitt with Craig-Hallum Capital Group. Please go ahead.

Good afternoon. Thank you for taking the questions and for the detailed update. Maybe first one, I think, John, you mentioned that headcount today is roughly half post the spin-off. Have all of the key roles with RemainCo, with Ligand, have those been filled? And where do you see the headcount, I guess, exiting the year? Or do you kind of feel like you've got the team in place that you need?

Yes. All the positions have been filled; completely filled out the executive and senior management team, the business operationally was about half and half. We had about 150 employees total and about half, while OmniAb was growing. Half with OmniAb and the other balance remains at Ligand. In a month or so at our Analyst Day, we'll discuss more about the headcount by business unit. We have a couple of technology platforms and the like. But this is a lean company, leaner certainly in cost and structure than we were a week ago. And that is by design. We can very efficiently drive early drug research; the licensing model, it's a very economical model from a headcount perspective to drive new deals. And that is our focus to keep costs low, but still drive the revenues and earnings and cash flows.

That's helpful. Thank you. And then more just a balance sheet item. So cash today, if I hold my math right, roughly $105 million because you've got the piece that went with OmniAb. Is that the number we should kind of be using as our base?

Yes. No. The $15 million commitment was net of expenses. So it was actually closer to $2 million. So the cash figures just a bit higher than what you just put out there.

Got it. That’s great. Thank you.

Your next question is from the line of Balaji Prasad with Barclays. Please go ahead.

This is Vishal for Balaji. Thanks for taking our questions. Firstly, could you add any color on which business segment that will drive your top line revenue growth post spin-off? Additionally, could you also provide some insights on the trajectory of your COVID-related capital revenue growth post 2023? Thank you very much.

Sure. The revenue consists of three main components: the primary one is royalty-based, the second is related to Captisol, and the third involves contract revenue like payments, milestones, and license fees. Typically, this year we've indicated that about 60% of our revenue is from royalties, 20% from Captisol, and the remaining 20% from contracts. With our revenue performance exceeding expectations, these proportions are shifting slightly, but the majority is still royalty-based, which has a 100% gross margin. This revenue sharing is tied to pharmaceutical products. In the royalty segment, Kyprolis is currently our largest revenue generator, followed by EVOMELA, teriparatide, and Rylaze. It's a diverse portfolio, and we will provide more insights on growth at Analyst Day next month. The foundation of our business is discovering drugs and sharing revenue with our partners through royalties. Regarding our partnership with Gilead for our COVID drug, when the pandemic began, Gilead had a promising therapeutic that required our agent for the antiviral. The large quantities they needed produced hundreds of millions in additional revenue for us. This year, we expected demand to decrease with the pandemic easing, anticipating $20 million, but we are now looking at nearly $85 million. This continues to be a significant cash flow driver, although we expect demand for this product to decline to zero in the coming quarters.

Thank you. That’s very helpful.

Your next question is from the line of Scott Henry with ROTH Capital. Please go ahead.

Thank you. Good afternoon. And first, I want to apologize. I have to join late today. So you may have touched on some of my questions and hopefully not, but they were important to me, so I did want to ask them. I guess, first, at the Investor Day on December 13, do you expect to give 2023 guidance? And similarly, I imagine if you want kind of an apples-to-apples comparison, everyone on the same page. It sounds like the presentation you'll probably give would be obviously ex OmniAb and probably ex-COVID as well. The question is, is that a fair assessment? And as well, do we have the historicals for all the quarters going back at this point or will some of those be filed in the near future? Thank you.

Yes. So Scott, this is Tavo. In terms of those historicals, you can get some of that information in the recently filed 8-K. Although I believe that's on a yearly basis, happy to provide that information. And for sure, we can prepare that for our anticipated Investor Analyst Day coming up.

Yes. We hope investors turn out in person ideally. The world is coming back. We've got significant in-person meetings coming up. Of course, we're just in Milwaukee and Chicago a few weeks ago. But virtually at the meeting, we will frame our 2023 financial outlook. We need a little more information in terms of product approvals to get clarity on some new revenue that we expect to start in 2023. So in fairness, I think we're going to have to caveat some of our guidance or bracket it around anticipated new revenue, but we will definitely get into the components of revenue, the expense structure and then ultimately, what our outlook is on a base case for earnings and cash flow. We are at a point now where the business, while investors know Ligand, the P&L has changed dramatically. It's simplified and it's going to be much more focused on growth metrics, top and bottom line and margin performance. So that is something that investors can expect. And I'm certain analysts will be updating their models and so on around that earnings event.

Okay. Great. I appreciate the color on both topics. Thank you for taking the questions.

Thank you. I appreciate the turnout today. Again, it's a momentous period for Ligand. It's been a busy period, for sure. We're going to be at the Credit Suisse conference tomorrow in person, and we look forward to that. We'll be at Stifel a week later. We have a number of non-deal road shows and of course, we'll be hosting the analyst and investor event in December. So we look forward to engaging with you. We will finish 2022 and welcome 2023. Thank you, everyone, for turning out for our Q3 earnings call.

Ladies and gentlemen, this does include the Ligand Pharmaceuticals Third Quarter 2022 Earnings Conference Call. Thank you for your participation. You may now disconnect.