Ligand Pharmaceuticals Q2 2024 Earnings Call Transcript

Quartr
Provided by Quartr
August 6, 2024

There are 9 speakers on the call.

Operator

Thank you. I would now like to turn the conference over to Tavo Espinoza, the Chief Financial Officer of Ligand Pharmaceuticals Inc. You may begin.

Speaker 1

Good afternoon, everyone, and welcome to Ligand's 2nd quarter earnings call. During the call today, we will review the financial results we released after today's market close and offer commentary on our partner pipeline and business development activity, followed by a question and answer session. Our earnings release and a link to today's webcast can be found in the Investor Relations section of our website at ligand.com. With me on the call today are CEO, Todd Davis Senior Vice President of Investments and Business Development, Paul Hadden and Senior Vice President of Investment and Head of Clinical Strategy, Doctor. Karen Reeves.

Speaker 1

This call is being recorded and the audio portion will be archived in the Investors section of our website. On today's call, we will make forward looking statements regarding our financial results and other matters related to the company's business. Please refer to the Safe Harbor statement related to these forward looking statements, which are subject to risks and uncertainties. We remind you that actual events or results may differ materially from those projected or discussed and that all forward looking statements are based upon current available information. Ligand assumes no obligation to update these statements.

Speaker 1

To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Ligand files with the Securities and Exchange Commission that can be found on Ligand's website at www.ligand.com or on the SEC's website at www.sec.gov. With that, I will now turn the call over to Todd.

Speaker 2

Thank you, Tawbo. On our last several calls, we have spent a fair amount of time talking about the steps we have taken to transform the company and strengthen and expand our royalty portfolio and team. I am pleased to report that during the Q2, we committed $175,000,000 to 2 new investment opportunities and added several commercial stage products to our portfolio. And we believe that we believe will be a meaningful contributors to our royalty revenue over the next several years. This includes 2 notable regulatory approvals of products with blockbuster sales potential Merck's CAP vaccine, the first pneumococcal conjugate vaccine specifically for adults that was approved by the FDA on June 17 and Verona Pharma's Otvare, the first inhaled product with a novel mechanism of action for the treatment of COPD maintenance in over 20 years.

Speaker 2

That NDA was approved by the FDA on June 26. Our royalty portfolio now includes 12 major commercial stage products, many that are marketed by premier global pharmaceutical companies. This is double the number of key marketed products we had in the portfolio at the beginning of 2023 and underscores the capabilities of our business development team and successful implementation of our OpEx flight investment focused corporate strategy. As a reminder, we also have more than 90 additional active pipeline programs in our portfolio that are in various stages of development. Paul and Karen will share additional updates on our pipeline later on the call.

Speaker 2

During the Q2, we also added several new team members, which deepened our investment, business development and operational bench. Michael Vigilante joined us in May as Vice President, Investments and Business Development. Michael served in a similar role at a Boston based life sciences investment firm and brings significant transaction and company building experience. We've also added Ruben Flores Saeb as Senior Director, Business Development in April. Ruben is leading our business development efforts with the Inventor community, having spent 12 years in industry and 10 years in the university technology transfer sector before joining Ligand.

Speaker 2

On the operations side, we also hired Marge Fekovec as Head of Human Resources. Marge has over 20 years of life sciences HR experience and will play a key role as we look to bring in additional talent to the company. These hires follow the additions of Rich Baxter, SVP of Investment Operations and Doctor. Karen Reeves earlier this year. As some of you may be aware, we filed an 8 ks on Friday announcing that Ligand's President and COO, Matt Kornberg, has decided to leave the company and and wish him well in future endeavors.

Speaker 2

Tawbo will do a deep dive into our financials for a second quarter and the first half of twenty twenty four. But let me provide a few financial highlights. Total revenue in the 2nd quarter grew 58%, driven in part by milestone payments we earned following the approvals of OTUVAIR and CABP vaccine, which Karen will discuss in greater detail. Our royalty revenue growth trajectory continued in the 2nd quarter, increasing 11% over the same period in 2023. We also announced an increase to our 2024 financial guidance in conjunction with the Pyron Biologics acquisition.

Speaker 2

We now expect total revenue to be in the range of $140,000,000 to $157,000,000 and core adjusted EPS to be in the range of $5 to $5.50 per share. Turning to slide 4, we will discuss Ligand's strategic differentiation. We are a biopharmaceutical company that seeks to offer profitable and compounding growth. Our diversified portfolio of royalty assets generates consistent and predictable revenues. We target late stage development assets where there is superior risk reward profile.

Speaker 2

There is sizable demand for capital in the life science industry. This allows us to invest selectively as we offer differentiated capital solutions that traditional investors cannot provide. Our strategy is executed on by our highly experienced investment team that can source, diligence and negotiate proprietary investments. Once originated, we can employ customized investment structures and novel tactics to create new investment opportunities. Our acquisition of a pyrone is a prime example of this.

Speaker 2

Royalty investing is a small percentage of the total capital that is invested today in life sciences. We believe our model is scalable and offers immense growth potential for years to come. Turning to Slide 5 for our royalty revenue outlook, we've made substantial progress to meet or exceed the longer term growth goals that we outlined at our Analyst Day in December of 2023. During the Q2, we saw an increase in Wall Street consensus estimates on several of our partnered products, including Trevera's Filspari. We also added several major new commercial products to the portfolio, including Captaxiv and OTUVERA, which are expected to launch later this year.

Speaker 2

We believe our revenue growth is on pace to exceed the 22% compound annual growth rate that we previously shared in December. The existing portfolio alone supports a royalty revenue CAGR of 18%. Future investments should add at least 4% to this, with potential upside on top of the current outlook. The operating leverage gain from our lean corporate cost structure is expected to result in adjusted EPS of greater than $10 per share in 20.28. Before I turn it over to Paul, I wanted to provide an update on PELTHOS.

Speaker 2

As I mentioned on our last earnings call, we created a new standalone company earlier this year called PELTHOS Therapeutics to commercialize zelstubmit, which was approved by the FDA in January for molluscum contagiosum. The PELTHOS team is preparing for the formal commercial launch of XELSUVME in the Q1 of 2025. We anticipate this will be done in partnership with a capital provider and or a strategic partner, which is the same approach that we took with Viking Therapeutics and Primrose Bio. This is consistent with our strategy to reposition and maximize the value of highly differentiated and promising pharmaceutical assets by combining premier management teams and 3rd party funding sources in return for significant equity and royalty rights in the newly formed entities. In conclusion, we are proud of all that we've accomplished in the first half of twenty twenty four, and we are very optimistic about our future prospects.

Speaker 2

I will now turn it over to Paul Hadden for a business development update. Paul?

Speaker 3

Thank you, Todd. I would like to take a moment to reflect on a number of exciting milestones we've achieved over the past 18 months. Today, I'm proud to say we've assembled a strong team of investment professionals. Moreover, we have developed a very robust proactive outbound sourcing capability. On this call, we are showcasing some of the fruits of those efforts, such as cross border M and A and venture outreach.

Speaker 3

Our team with decades of investing experience has a number of structural tools in our toolkits. With proprietary sourcing ability, we're able to pursue a robust number of exciting investment opportunities across multiple therapeutic areas within the global biopharma sector. Turning to Slide 7. We now have an investment office and team that is headquartered in Boston, one of the most prolific life science hubs across the globe. Over the past 18 months, we have committed over $275,000,000 across 12 new investments.

Speaker 3

I'm very proud of our team and what we've accomplished in such a short time period

Speaker 4

and I'm even more excited for

Speaker 3

the future. Now let me highlight several of our key investments over the past few months. Turning to Slide 8, on July 8, we announced the $100,000,000 acquisition of Apiron Biologics, an investment that had been in the works for months. Apyron was in a privately held Austrian based biotechnology company that receives royalties on Carziba, an approved monoclonal antibody for one of the most common forms of pediatric cancer, neuroblastoma. The product was approved in Europe in 2017.

Speaker 3

It is now marketed in over 35 countries worldwide and is well entrenched in pediatric oncology treatment guidelines. Importantly, the royalty rate is a healthy 15% to 20% of net sales. Royalties over the past 12 months were in excess of €20,000,000 and the acquisition was highly accretive to Ligand given the near 100% profitability. Finally, although RecordID is evaluating a U. S.

Speaker 3

Path to market, our base case projections did not include U. S. Sales or approvals. The acquisition, which closed a week later, is immediately accretive by $1 per share on an annualized basis. This acquisition was a true team effort and we thank the Apirone shareholders for selecting Ligand as their partner.

Speaker 3

CarZiba with its long dated IP and lack of near term competitive threats will carry Ligand's oncology royalties well into the next decade. We are excited to welcome Recordati, CARZYBA's marketer as a partner of Ligand's and look forward to working with them to support Carziva's continued access to young cancer patients and their families globally. Turning to Slide 9. Karen will discuss Verona's recently approved O2VARE program. I would like to note that today we are sharing that during the last 6 months, we purchased additional royalties from Inventors for approximately $17,000,000 These acquisitions further strengthen our exposure to the 1st novel inhaled treatment approved in COPD in over 20 years.

Speaker 3

This brings our total O2VARE royalty to just under 3% of net sales. These investments also showcase our team's ability to meet the needs of individual inventors who are seeking to diversify away from single royalty asset risk for wealth planning and charitable endeavors. These add on investments are very low friction as they are executed on fully diligence products that are already part of our portfolio. Turning to Slide 10. With respect to our investment in cetiklostat, Takeda's President of R and D stated the following on their earnings call on July 31st, and I quote, As previously communicated, saticlostat failed to demonstrate clinical benefit in Lennox Gastaut.

Speaker 3

Sotiglasat also failed to meet its primary endpoint in the Dravet syndrome Phase 3 trial, narrowly missing with a p value of 0.06. However, the totality of data from this study had a meaningful effect on key secondary endpoints and when combined with the highly significant results from the large Phase 2 study suggest clear clinical benefits for cetiklostat and Dravet patients with a differentiated safety profile. Given the large unmet need in Dravet, we are investigating a potential regulatory path forward. From Ligand's standpoint, while we expected a stronger top line data announcement, we are encouraged by Takeda's continued drive to secure a potential path forward for these rare epilepsy patients who have limited options. As we learn more, we will update accordingly.

Speaker 3

Turning to Slide 11. For the Q2, we made a $75,000,000 investment across several clinical stage oncology royalties with Agenus. Assets and 1 synthetic royalty in their lead internal pipeline program, Botvao. Having completed their end of Phase 2 meeting with the FDA, Agenus has clarity on their Phase 3 dose, which is an important achievement. Our team invested based on the strength of existing data and we will be focusing on monitoring the maturing study.

Speaker 3

This program has significant potential to be an important addition for metastatic colorectal cancer patients in later lines of therapy as well as other potential expansion indications. Finally, Agenus will likely need to partner to achieve their global development plan and ambitions and their team has been consistent in that messaging. We are focused on the development of this data and monitoring the partnering process. Additionally, Agenus may revisit accelerated approval once the data is more mature. We recently learned that select partner programs are being returned to Agenus.

Speaker 3

Agenus has an obligation to seek to relicense these programs and Ligand will maintain our economics. Turning to Slide 12. On July 24, our partner Palvella Therapeutics announced a definitive merger agreement with NASDAQ listed Pieris Pharmaceuticals alongside a new and substantial equity raise of nearly $80,000,000 in fresh capital from leading institutional investors. This will capitalize the company into 2027, a significant strengthening and derisking achievement for the company and our interest in their lead asset. We continue to be supportive of Palvella and its breakthrough therapy designation and Fast Track Status Cutorin program in MLM.

Speaker 3

We look forward to their continued progress and success. 13, our origination capabilities are foundational to our strategy. Our investment pipeline is strong and populated with multiple proprietary opportunities that cannot be accessed or replicated through the public markets. We have reviewed nearly 100 opportunities so far this year across multiple therapeutic areas. In closing, we are pleased with the continued progress of our unique investment strategy and our team's performance.

Speaker 3

Our portfolio continues to strengthen and mature, and we look forward to updating you in the coming quarters. I'll now turn it over to Karen.

Speaker 5

Thank you, Paul. Today, we'd like to highlight some key commercial products in our portfolio. Turning to Slide 14. Let's look at Trevir Therapeutics, Filspari. We license worldwide rights for Filspari to Trevir and are entitled to milestones and a 9% royalty on global net product sales.

Speaker 5

Over the past 18 months, Vilspari has achieved several major milestones, underscoring the significant potential of this product. Vilspari is a dual endothelin 1 and angiotensin 2 receptor antagonist. In February 2023, VILspari received accelerated approval from the FDA for primary IgA nephropathy, which affects an estimated 150,000 people in the U. S. IGAN is a progressive kidney disease that leads to hampered kidney filtering, proteinuria and progressive kidney function loss.

Speaker 5

The basis of the FDA accelerated approval was Trevir's Phase 3 PROTECT study, which met its pre specified interim primary endpoint, mean reduction of proteinuria. Filspari became commercially available in the U. S. In late February 2023. Trevir filed a supplemental NDA in March 2024 to convert the accelerated approval to full approval with an expected PDUFA date of September 5.

Speaker 5

The sNDA will provide additional efficacy and safety information to regulators to inform the label. Trevir indicates that if they receive a broader label, the addressable IGAN patient population could nearly double from the current level. We see it as positive that the FDA has not requested an advisory committee and that the PDUFA date to determine full approval is on track. In Europe, Travir and CSL v4 announced in April that the European Commission granted conditional marketing authorization for VILspari for the treatment of primary IgAN. Trevir has reported, Telspari is expected to launch in the first EU markets in the second half of twenty twenty four.

Speaker 5

In addition, the new kidney disease improving global outcome, the DIGO guidelines are anticipated for IGAN in 2024. We believe the new guidelines may potentially underscore the importance of treating proteinuria early and aggressively. Proteinuria is being accepted as the predictor of clinical outcome. As scientists and doctors better understand the pathogenesis and course of IgAN, combination and complementary therapy may be important for future treatment. Regarding the launch progress, Prevea reported net product sales of $27,100,000 during the Q2, which represented strong growth of 37% over the prior quarter.

Speaker 5

Analysts are projecting PEAT's global sofari sales of $500,000,000 to $700,000,000 Turning to Slide 15. Let's look at one of our most recent pipeline wins, Verona Pharma's O2Bear. O2Ver previously known as ensifentrine received FDA approval on June 26 and is indicated for the maintenance treatment of chronic obstructive pulmonary disease allowing for broad use in adults with COPD. Otvair is a novel dual phosphodiesterase inhibitor with bronchodilator and anti inflammatory effects that is administered twice daily via nebulized inhalation. It is the 1st inhaled product with a novel mode of action approved for the maintenance of COPD in more than 20 years.

Speaker 5

The primary endpoints in both Phase III trials, ENHANCE I and ENHANCE II were statistically significant for improving lung function. COPD is the 6th leading cause of death in the U. S. COPD also accounts for nearly 800,000 emergency room visits a year where COPD is the primary diagnosis. Patients with COPD struggle to breathe and even ordinary daily activities can be daunting.

Speaker 5

O2VARE's broad indication in the maintenance treatment of COPD means it can be used as standalone monotherapy or in combination treatment with other drugs. There is no need to consider blood eosinophilia. Varona's launch preparations are well underway. With the U. S.

Speaker 5

Approval, Varona has hired 120 field personnel. As of late June, Verona reports these representatives had already scheduled approximately 1800 healthcare provider appointments to occur during the 1st 3 months of launch. In June, Verona also announced a monthly WACC price of $2,950 for OTUVIRA. This represents a premium to other nebulized COPD treatments. Verona estimates that the vast majority of OTUVIRA patients will receive coverage under their medical benefit.

Speaker 5

Verona reports that there are an estimated 8,500,000 people living with COPD in the US today, half of whom remain persistently symptomatic despite treatment and will be the focus of O2VIR's launch. Analysts expect O2VIR to be a blockbuster product and we look forward to updates from VIRONA as the launch progresses during the 3rd and 4th quarters. Turning to Slide 16. Now let's turn to Merck's CABP vaccine, another recent pipeline win. CAP vaccine, previously known as V114, is a pneumococcal 21 valent conjugate vaccine that received FDA approval on June 17th for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults.

Speaker 5

The FDA summary basis for regulatory action states and I quote, FDA granted priority review on December 15, 2023 with the justification that Cabaxi meets the qualifying criteria as a drug that treats or prevents serious conditions, IBD and pneumonia and provides a significant improvement in effectiveness over currently licensed pneumococcal conjugated vaccine, end quote. TABC is specifically designed for adults that includes 8 streptococcus pneumonia serotypes not covered by other currently approved pneumococcal vaccines on the market today. In their latest earnings call, Merck stated, given its compelling clinical profile, we expect that tab vaccine will achieve a majority market share in the adult setting. The last thing I want to highlight is that on June 27th, the CDC's Advisory Committee on Immunization Practices, also known as ACIP, recommended hep FASB for all adults aged 65 years and older who have not previously received a pneumococcal conjugate vaccine or whose vaccine history is unknown. And for adults 19 to 64 years old with certain underlying medical conditions among other situations.

Speaker 5

At its October meeting, ACIP may consider broadening this to all adults aged 50 to 64. Analysts believe this could potentially double the size of the CABP vaccine's commercial opportunity. With that, I will now turn the call over to TAVO for the financial updates.

Speaker 1

Thanks, Karen. Let's move to Slide 17, please. First, I want to highlight that I will be discussing non GAAP results, which excludes certain items, including stock based compensation, amortization of intangible assets, amortization and or impairment of financial assets, unrealized gains or losses from short term investments, our share of losses absorbed from accounting for our investment in Primrose Bio under the equity method and expenses incurred to incubate the Peltos business amongst others. In addition, to further focus our investors on the core business results, we adjust for 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.

Speaker 1

We believe that the adjusted measures can assist investors in analyzing and assessing our past and future core operating performance. We reported another quarter of strong financial results with total Q2 2024 revenue growing by 58% to $41,500,000 and core adjusted EPS growing 121 percent to $1.40 when compared to the Q2 of 2023. Royalty revenue grew to $23,200,000 or 11% over the prior year quarter with Travere's Filspari being a key driver. We ended the quarter with just under $230,000,000 in cash and investments and over $350,000,000 in deployable capital when you include the $125,000,000 available under the credit facility we have with Citibank. Slide 18 frames up our financial results in more detail.

Speaker 1

Like I mentioned, we reported total 2nd quarter revenue of $41,500,000 which is 58% above the $26,400,000 we reported in the prior year quarter. The increase in total revenue is due primarily to the milestones we earned from the regulatory approvals of Trevirosil Spare, Verona's Autuber and Merck's CapEx. Royalty revenue increased to $23,200,000 from $20,900,000 in the prior year quarter with the growth driven by an increase in sales of Trevera Silspari, which reported sales of $27,100,000 dollars this quarter versus $3,500,000 in the prior year quarter. As a reminder, we own a we earn a 9% royalty on sales of Silspari. Other major contributors to royalty revenue this quarter include Jazz's Rylase with reported Q2 sales of 107,800,000 dollars and Merck's Vax NuVance with reported sales of $189,000,000 We believe these royalty assets along with the recently approved products as well as Carziba will continue to drive royalty revenue growth in the future.

Speaker 1

Captisol sales were $7,500,000 in the Q2 of 2024 versus $5,200,000 in the prior year quarter, with the increase due to timing of customer orders. Contract revenue this quarter was $10,900,000 and is due primarily to the 3 product approvals this quarter, namely the $2,300,000 milestone payment earned from the European approval of Filsparie, the $5,800,000 earned from the approval of Autobare and the $2,000,000 earned from the approval of CapEx II. Moving on to operating expenses. R and D expenses decreased from $6,900,000 in the prior year quarter to $5,400,000 in Q2 'twenty four with the decrease driven primarily by lower headcount resulting from last year's Pelican business spin out. G and A expenses increased from $11,300,000 in the prior year quarter to $17,600,000 in Q2 2024.

Speaker 1

The $6,300,000 increase is driven primarily by the $4,700,000 investment made to incubate the Peltos business this quarter as well as investments made to build up our business development and investment team in Boston. As we've mentioned on previous calls, we expect to incur incremental operating costs associated with incubating the Peltos business. Our intent is to spin out and or out license the Peltos business and therefore we are adjusting out these expenses for purposes of reporting adjusted non GAAP earnings. The $26,500,000 recorded to financial royalty asset impairment is primarily attributable to the reduction in the carrying value of our investment in Takeda's saticlustat as a result of the Phase 3 results recently announced by Takeda that was previously discussed by Paul. The $32,000,000 recorded to other expense is primarily related to the non cash decrease in the carrying value of our Primrose Bio investment.

Speaker 1

Our equity ownership interest in Primrose Bio has decreased from 49.9% to 34.3% in connection with the recent financial financing round. The financing round was at evaluation below the value arrived at when we spun out the Pelican business in September of 2023, which resulted in a reduction in the carrying value of our investment. GAAP net loss in the Q2 of 2024 was 51,900,000

Speaker 4

dollars or $2.88 per share

Speaker 1

versus GAAP net income of $2,300,000 or $0.13 per diluted share in the prior year quarter. The change in GAAP EPS is largely due to the reduction in carrying value of the satyclastat asset and the fair value adjustments in our investment in Primrose Bio. Excluding the impact of these as well as the other non GAAP adjustments described earlier, core adjusted net income in the Q2 of 2024 was $25,800,000 or $1.40 per diluted share versus $11,700,000 or $0.66 per diluted share in the prior year quarter. Turning to the balance sheet. As of June 30, 2024, we had cash and short term investments of $227,000,000 which includes $53,000,000 of our holdings in Viking common stock.

Speaker 1

We expect that our current cash plus annual cash flow generation will be sufficient to fund the investment activity we anticipate over the foreseeable future. We did not sell any shares of Viking stock this quarter. However, we did enter into a caller option agreement to hedge against Viking stock price fluctuation risk. We recorded a $15,200,000 unrealized gain associated with the collar option agreement in Q2 2024 and the value of that derivative asset is classified in other current assets. In addition, this quarter we expanded our credit facility with Citibank by $50,000,000 and now have $125,000,000 available to us under that credit facility.

Speaker 1

Turning now to guidance under slide 19. As mentioned earlier, we are reaffirming the updated 2024 financial guidance we gave on July 8 in conjunction with the Aviron acquisition announcement. We expect 2024 royalty revenue will be in the range of $100,000,000 to 105,000,000 dollars sales of Captisol in the range of $25,000,000 to $27,000,000 and contract revenue in the range of $15,000,000 to 25,000,000 dollars These revenue components result in total revenue guidance of $140,000,000 to $157,000,000 and adjusted earnings per diluted share of $5 to $5.50 Year to date, we've recorded total revenue of $73,000,000 and core adjusted EPS of $2.61 We feel confident that we're on track to meet or exceed our updated 2024 financial guidance. We also continue to feel confident about the longer term outlook we've shared, which goes out to 2028 and calls for royalty revenue growing at a compound annual growth rate of above 20% and adjusted core EPS growing even faster at a compound annual growth rate above 25%. Finally, I'd like to direct listeners to our Q2 earnings press release issued earlier today, including a reconciliation of GAAP results to the adjusted financial results, which is available on our website.

Speaker 1

I'll now turn the call over to Todd for closing comments.

Speaker 2

Thank you, Thabo. I want to thank everyone for joining us today. We've made tremendous progress at Ligand in the first half of twenty twenty four. Ligand has a scalable business model and an efficient low cost infrastructure. We continue to grow our portfolio of royalty generating assets.

Speaker 2

We are steadily increasing our major commercial stage products and the pace of our investment activity continues to accelerate. We have set ambitious yet realistic targets for long term growth and believe we are well positioned to create further value for our shareholders. We will now open up the call for questions.

Operator

Thank you. We will now begin the question and answer session. And your first question comes from the line of Matt Hewitt of Craig Hallum. Please go ahead. Mr.

Operator

Matt Hewitt?

Speaker 4

Yes. Can you hear me?

Speaker 2

We got you. Yes. Now we can.

Speaker 4

Okay. Well, congratulations on an active quarter. Maybe first up, starting with the Palfos opportunity, an update on how those partnership discussions are going? And once that asset is kind of spun off, do you anticipate recovering these upfront costs that you've been putting into the business here since you acquired the asset?

Speaker 2

Thank you, Matt. Yes, we have several tangible discussions ongoing in parallel, ranging from straight financing options, which will be effectively a spin out similar to what we did with Viking Therapeutics or what we witnessed this quarter with Primrose Bio raising additional capital into that company, but also strategic licensing and potentially strategic merger opportunities. So those are ongoing. And as you know, we commit to incubating these things and spinning them out as an investment thesis. We believe this is the optimal way to commercialize this asset.

Speaker 2

And we will not rush it, but we're pretty confident that we'll have success in our efforts to spin this out. And I would say the process and the progress is going very well.

Speaker 4

Excellent. And then maybe one for me and one more and then I'll hop back in the queue. But regarding CarZiba, how should we be thinking about the growth of that asset? We don't have I don't have a good sense for how fast those revenues are growing and what that would mean for your royalty stream? Thank you.

Speaker 3

Yes. So, great question. This is Paul. I'll take that head on. So, for record, Adi, this is a growth asset.

Speaker 3

I think if you go to their earnings, the most recent earnings announcement, their oncology franchise put up net revenue of €117,000,000 which was growing at a rate of 22.7%. And they said it was mainly driven by Carziva with continued growth of SILVANT, another product that we don't have royalty on. But to state the obvious, this is a growth asset. It's been on the market for 7 years, but it continues to penetrate new territories and regions. In fact, just last month, they secured an approval in South Korea.

Speaker 3

And we see this growing for the foreseeable future, which is why we were eager to bring it into the Ligand portfolio.

Speaker 1

And then, Mahershala I would just add, if you want to take a look at Slide 5, we do have that layered into our longer term outlook, if you want to get a sense for our view on that royalty stream.

Speaker 4

Got it. All right. Thank you very much. Congratulations on the strong quarter.

Speaker 2

Thank you.

Operator

Your next question comes from the line of Douglas Meem of RBC Capital Markets. Please go ahead.

Speaker 6

Yes, good afternoon. A couple of questions. First one, maybe if you could talk about H2 'twenty four and the outlook and maybe sizing of potential deals that you're contemplating. I believe you like to spend $200,000,000 maybe $250,000,000 a year for these investments. And I'm just wondering if we're thinking about things in the range of $25,000,000 to $75,000,000 through to the end of 2024.

Speaker 2

Yes, sure. I believe this is Todd speaking, but we have a pretty active pipeline now. When we are making new commitments to investments, we are trying to build a diversified portfolio, of course. And we have been operating at a pace and have built a team to be able to kind of functionally invest about $200,000,000 per year. And that's what we're planning on.

Speaker 2

There can be some variation around that. And of course, the more recent investment was a fairly large one at $100,000,000 although it's cash generative immediately, which offsets that significantly. But in general, we're typically looking at diversification by asset size And we're typically not going to make more than a $30,000,000 to $40,000,000 commitment per asset. So, we might get a couple more deals done this year, would be a good base case. But there could be some variation depending on how the discussions go.

Speaker 2

But I think that's a good expectation.

Speaker 6

Okay. That's great. Thank you. And then as you look at the new product, OTUVAIR and its potential launch, well, I guess shortly, we know pricing now, they've already set up meetings. Obviously going to be an exciting product for the company.

Speaker 6

I'm curious that royalty, the $13,800,000 or milestone should come in, in Q3. Would that be fair?

Speaker 1

Yes. We've got that factored into our forecast contract revenue forecast for the year. And the company, Rona, has said that they do plan to launch. And if it's not in Q3, probably likely in Q4.

Speaker 6

Yes. Okay. That makes sense. And then just let me wrap up with you have increased the line, although it doesn't look like you need to use it. But under what circumstances would you expect to draw on the line that is available to you and I'll wrap it up there?

Speaker 6

Thank you.

Speaker 2

Yes, I think we are going to try to maintain kind of reasonable cash balances. If our pace of investment accelerates significantly, we may start to draw down some of that balance. But we'll generate and Togo can give you the estimates, but in the second half of the year, we should be close to $50,000,000 of new cash flow generation, over $100,000,000 next year. So, I don't feel like it's imminent. And at our current pace, with the current pipeline, the activity set we're looking at, I would not expect that to be an imminent activity.

Speaker 2

We have plenty of runway from where we are right now.

Speaker 1

I can tell you, Doug, I'm not including any interest expense in our guidance for 2024. And the run rate on cash the cash operating run rate is above $100,000,000 a year at this point.

Operator

Your next question comes from the line of Joe Pantginis of H. C. Wainwright and Company. Please go ahead.

Speaker 5

Hi, this is Josh on

Speaker 7

for Joe. Thanks for taking our questions. So as Capital continues to provide an important revenue stream for you guys, I was wondering if you guys could describe the research versus the commercial mix and how your BD efforts are currently going both inbound and outbound? Thanks.

Speaker 1

Yes. No, the commercial versus research mix leans very heavily on the commercial side. I would say it's probably 85% commercial and 15% research use. But then in terms of the actual quantity of customers, I would say it's perhaps maybe the inverse. We have large customers that take in significant amount of commercial product, but then a significantly larger amount of customers that take in lower volumes of Captisol for their research needs.

Speaker 3

Thank you.

Speaker 1

Was there a second portion of that question that I didn't address?

Speaker 7

Just about the BD efforts, inbound and outbound.

Speaker 2

Yes. So, I would say that there's a steady pace of deal flow around the Captisol business. We are conducting a strategic review there and looking at different ways to accelerate that, expand the business, etcetera. So that's part of our we spent the first half of 2023 really building out the investment team and the second half commencing the execution through till now. And there's significant operational focus right now in terms of are we really using best deal generation, around our platform technologies, in terms of monetizing existing assets that we have on our platforms.

Speaker 2

For example, the nitric oxide platform that we purchased, we're very focused on the Xilseutinib launch. But there are a number of other high potential clinical assets that came out of that acquisition. So, I do think that we can do a better job on that and that's a focus of us this year and right now in fact reviewing our management practices, are we optimizing there and asking ourselves what we can do better. So, give us some time, but we hope to have, frankly, greater yield on those activities going forward.

Operator

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

Speaker 6

Good afternoon. This is Shao on for Balaji. Thanks for taking our question. The question is about Cabralaxi. Based on the chart on Slide 16, seems like you guys are expecting a relatively rapid uptake from 2024 to 2026 with around $500,000,000 annual sales in year 2026.

Speaker 6

So with that, could you give us a ballpark range on how much of this asset could drive your royalty revenue growth for the next 3 years? And would Vax Nuveins a good benchmark to consider? Thanks.

Speaker 4

Yes.

Speaker 1

I guess I would want to first say that the chart there that you referenced is those are analyst consensus numbers. And then if you want to get a sense for how we think that how that plays out on the top line royalty revenue stream going after 2028, I would just refer you to Slide 5.

Speaker 8

Got it.

Operator

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

Speaker 8

Good afternoon. I echo the congrats on an active and good quarter. I guess, first question, just to clarify. So the guidance change, which you did a few weeks back, essentially $10,000,000 of the royalty that's from the Pyron acquisition and then there's timing, I mean, not timing, there's the milestone payments for the remainder, right, basic essentially, is that?

Speaker 1

That's right. You got that right, Larry. Yes.

Speaker 8

Okay, great. And then the and then, I'm just curious just on sourcing. So it looks like you acquired this asset for basically about 5 times royalty. And it sounds like it's not there's some it's growing and doesn't include the U. S, which could potentially accelerate growth.

Speaker 8

Just curious on how this asset came about, sourcing of it and whatnot, without divulging any secret sauce, but just curious if there's anything you could share?

Speaker 2

Yes. There's a lot of effort that goes into our origination efforts, but I'll let Paul answer that since he actually originated that deal.

Speaker 3

Yes, it's a great question. I guess, in short, it was proprietary opportunity. There were some relationships involved that go back many years. And the reason why we were able to secure it is because we were able to acquire the shares for the selling shareholders. There were significant benefits to them from a tax perspective.

Speaker 3

And so it really made a lot of sense on both sides of the transaction. And obviously, our team's experience and diligence in underwriting these types of complex cross border transactions came into play. So it just made a lot of sense. And there are some future earn outs that were referenced in the press release. And so really we're happy to be the proud owners of the Pyron.

Speaker 8

Got it. Great. If I could just switch gears and squeeze one more in. Just on the CapEx, just another follow-up question on that. Again, not looking at the slide as an exact science, but it looks like based on what Vax NuVance is today and my limited knowledge on this market, Is this the new Macauqua vaccine, the market in general, right?

Speaker 8

I guess it's adult and there's a pediatric side. Is the adult market today as big or even bigger than the pediatric? I guess is question A. And then B, is this ASIC recommendation a change from what historical or standard of care is today? That's it.

Speaker 8

Thanks.

Speaker 1

Yes. I mean, I can give you my perspective on Vax new vans, formerly known as V114. And so that program is trending towards blockbuster status, with Merck. Capaxit, we're not quite sure how the dynamics will play out there with the existing product. Pfizer, Prevnar, clearly the market leader, I think, dollars 6,000,000,000 to $7,000,000,000 market there.

Speaker 1

And so, analysts expect CapEx to as we show on the chart there to eclipse the $1,000,000,000 mark as well. So, we're excited about that, that royalties ring coming in future, but it's still early.

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Earnings Conference Call
Ligand Pharmaceuticals Q2 2024
00:00 / 00:00