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spk02: Thank you for standing by my name is Pam and I will be your conference operator today at this time, I would like to welcome everyone to the ligand second quarter 2024 earnings webcast. All lines have been placed on mute to prevent any background noise after the speakers remarks, there will be a question and answer session. If you would like to ask a question during this time simply press star followed by the number one on your cell phone keypad. If you would like to withdraw your question, press star 1 again. Thank you. I would now like to turn the conference over to Tavo Espinoza, the Chief Financial Officer of Ligon Pharmaceuticals, Inc. You may begin.
spk08: Good afternoon, everyone, and welcome to Ligon's second 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 Haddon, and Senior Vice President of Investment and Head of Clinical Strategy Dr. Karen Reeves. This call is being recorded and the audio portion will be archived in the investor 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. LIGAN assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Ligand 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.
spk00: Thank you, Thabo. 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 second quarter, we committed $175 million to two new investment opportunities and added several commercial stage products to our portfolio that we believe will be meaningful contributors to our royalty revenue over the next several years. This includes two notable regulatory approvals of products with blockbuster sales potential. Merck's Capvaxiv, the first pneumococcal conjugate vaccine specifically for adults that was approved by the FDA on June 17th. And Verona Pharma's Otuver, the first inhaled product with a novel mechanism of action for the treatment of COPD maintenance in over 20 years. That NDA was approved by the FDA on June 26th. 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 OPEC slight 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. During the second quarter, we also added several new team members, which deepen 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 Saib 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 LIGAN. 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 Dr. Karen Reeves earlier this year. As some of you may be aware, we filed an 8K on Friday announcing that Ligand's president and COO, Matt Kornberg, has decided to leave the company and pursue other opportunities. Matt has agreed to serve as consultant through the end of the year. We are grateful for Matt's many contributions to the company over the last nine years and wish him well in future endeavors. Tavo will do a deep dive into our financials for a second quarter and the first half of 2024. But let me provide a few financial highlights. Total revenue in the second quarter grew 58%, driven in part by milestone payments we earned following the approvals of O2 there and capped vaccine. which Karen will discuss in greater detail. Our royalty revenue growth trajectory continued in the second quarter, increasing 11% over the same period in 2023. We also announced an increase to our 2024 financial guidance in conjunction with the Epiron biologics acquisition. We now expect total revenue to be in the range of 140 to 157 million and Core Adjusted EPS to be in the range of $5 to $5.50 per share. Turning to slide four, 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. 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. 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 five 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 second quarter, we saw an increase in Wall Street consensus estimates on several of our partner products, including Travere's PhilSparry. We also added several major new commercial products to the portfolio, including Capvaxiv and O2Var, which are expected to launch later this year. 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 2028. Before I turn it over to Paul, I wanted to provide an update on Pelphos. As I mentioned on our last earnings call, we created a new standalone company earlier this year called Pelphos Therapeutics to commercialize zelsovmi, which was approved by the FDA in January for molluscum contagiosum. The Pelthos team is preparing for the formal commercial launch of Zelsudmi in the first quarter 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 third-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 24, and we are very optimistic about our future prospects. I will now turn it over to Paul Haddon for a business development update. Paul?
spk07: 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&A and inventor outreach. Our team, with decades of investing experience, has a number of structural tools in our toolkit. 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 seven. 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 million across 12 new investments. I'm very proud of our team and what we've accomplished in such a short time period and I'm even more excited for the future. Now let me highlight several of our key investments over the past few months. Turning to slide eight, on July 8th, we announced the $100 million acquisition of Apiron Biologics, an investment that had been in the works for months. Apiron was a privately held Austrian-based biotechnology company that receives royalties on Carziva, an approved monoclonal antibody for one of the most common forms of pediatric cancer, neuroblastoma. The product was approved in Europe in 2017. 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 million euros, and the acquisition was highly accretive to Ligan given the near 100% profitability. Finally, although Recordati is evaluating a U.S. path to market, our base case projections did not include U.S. sales or approval. 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 Epiron shareholders for selecting Ligan as their partner. 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 Rekordati, Carzeba's marketer, as a partner of Ligand's, and look forward to working with them to support Carzeba's continued access to young cancer patients and their families globally. Turning to slide nine. Karen will discuss Verona's recently approved O2-Ver program, but I would like to note that today we are sharing that during the last six months, we purchased additional royalties from inventors for approximately $17 million. These acquisitions further strengthen our exposure to the first novel inhaled treatment approved in COPD in over 20 years. This brings our total O2 VAR 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-diligent products that are already part of our portfolio. Turning to slide 10, with respect to our investment in Statiklestat, Takeda's president of R&D stated the following on their earnings call on July 31st, and I quote, as previously communicated, Statiklestat failed to demonstrate clinical benefit in Lennox-Gastaut. Sotiklostat 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 Sotiklostat and Dravet patients with a differentiated safety profile. Given the large unmet need in Dravet, we are investigating a potential regulatory path forward, end quote. From YGAM'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. Turning to slide 11. Second quarter, we made a $75 million investment across several clinical stage oncology royalties with Agenis. Our assets and one synthetic royalty in their lead internal pipeline program, PlotVal. Having completed their end of phase two meeting with the FDA, Agenis has clarity on their phase three 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. 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, agenists will likely need to partner to achieve their global development plan 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, agenists may revisit accelerated approval once the data is more mature. We recently learned that select partner programs are being returned to Agenis. Agenis has an obligation to seek to relicense these programs, and Ligand will maintain our economics. Turn to slide 12. On July 24th, our partner, Palvela Therapeutics, announced a definitive merger agreement with NASDAQ-listed Peiris Pharmaceuticals, alongside a new and substantial equity raise of nearly $80 million in fresh capital from leading institutional investors. This will capitalize the company into 2027, a significant strengthening and de-risking achievement for the company and our interest in their lead asset. We continue to be supportive of Palpella and its Breakthrough Therapy designation and Fast-Track Status Q-Torrent program in MLM. 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. 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.
spk01: Thank you, Paul. Today we'd like to highlight some key commercial products in our portfolio. Turning to slide 14, let's look at Travere Therapeutics' PhilSparry. We license worldwide rights for PhilSparry to Travere and are entitled to milestones and a 9% royalty on global net product sales. Over the past 18 months, Silspari has achieved several major milestones, underscoring the significant potential of this product. Silspari is a dual endothelin 1 and angiotensin 2 receptor antagonist. In February 2023, Silspari 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. The basis of the FDA accelerated approval was Travere's Phase III PROTECT study, which met its pre-specified interim primary endpoint, mean reduction of proteinuria. Silspari became commercially available in the U.S. in late February 2023. Trevere filed a supplemental NDA in March 2024 to convert the accelerated approval to full approval with an expected to do for the day of September 5th. The SNDA will provide additional efficacy and safety information to regulators to inform the label. Trevere 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 BDUFA date to determine full approval is on track. In Europe, TREVIR and CSLV4 announced in April that the European Commission granted conditional marketing authorization for Filspari for the treatment of primary IGAN. Trevere has reported SELFARI is expected to launch in the first EU markets in the second half of 2024. In addition, the new kidney disease improving global outcomes, the DEGO 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 outcomes. 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, Previer reported net product sales of $27.1 million, during the second quarter, which represented strong growth of 37% over the prior quarter. Analysts are projecting peak global Safari sales of 500 to 700 million. Turning to slide 15, let's look at one of our most recent pipeline wins, Verona Pharma's O2VeR. O2VeR, previously known as Encephentrine, 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. O2Vir is a novel dual phosphodiesterase inhibitor with bronchodilator and anti-inflammatory effects that is administered twice daily via nebulized inhalation. It is the first inhaled product with a novel mode of action approved for the maintenance of COPD in more than 20 years. The primary endpoints in both phase three trials, enhanced one and enhanced two, were statistically significant for improving lung function. COPD is the sixth 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. O2Vir'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. Verona's launch preparations are well underway. With the U.S. approval, Verona has hired 120 field personnel. As of late June, Verona reports these representatives had already scheduled approximately 1,800 healthcare provider appointments to occur during the first three months of launch. In June, Verona also announced a monthly WAC price of $2,950 for Otuver. This represents a premium to other nebulized COPD treatments. Verona estimates that the vast majority of O2Vir patients will receive coverage under their medical benefits. Verona reports that there are an estimated 8.5 million people living with COPD in the U.S. 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 Verona as the launch progresses during the third and fourth quarters. Turning to slide 16. Now let's turn to Merck's Capvaxiz, another recent pipeline win. Capvaxiz, previously known as V116, 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. The FDA's summary basis for regulatory action states, and I quote, FDA granted priority review on December 15, 2023 with the justification that CABACC meets the qualifying criteria as a drug that treats or prevents serious conditions, IBD and pneumonia, and provides a significant improvement in infectiveness over currently licensed pneumococcal conjugated vaccines, end quote. Tabaxi is specifically designed for adults and includes eight streptococcus pneumonia serotypes not covered by other currently approved pneumococcal vaccines on the market today. In their latest earnings column, Merck stated, Given its compelling clinical profile, we expect that Tabaxi 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 Tabaxi for all adults age 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. At its October meeting, ACIP may consider broadening this to all adults age 50 to 64. Analysts believe this could potentially double the size of the tap vaccine commercial opportunity. With that, I will now turn the call over to Thabo for the financial update.
spk08: Thanks, Karen. Let's move to slide 17, please. First, I want to highlight that I will be discussing non-GAAP results which exclude 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 Therapeutic stock. I encourage you to review the GAAP reconciliation of these non-GAAP measures, which can be found in today's release available on our website. We 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 24 revenue growing by 58%, to $41.5 million and Core Adjusted EPS growing 121% to $1.40 when compared to the second quarter of 2023. Royalty revenue grew to $23.2 million or 11% over the prior year quarter with Traverse Pillsparry being a key driver. We ended the quarter with just under $230 million in cash and investments and over 350 million in deployable capital when you include the 125 million available under the credit facility we have with Citibank. Slide 18 frames up our financial results in more detail. Like I mentioned, we reported total second quarter revenue of 41.5 million, which is 58% above the 26.4 million 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 Traverse Filspari, Verona's Auteuver, and Merck's Capvaxiv. Royalty revenue increased to $23.2 million from $20.9 million in the prior year quarter, with the growth driven by an increase in sales of Traverse Filspari, which reported sales of $27.1 million this quarter versus $3.5 million in the prior year quarter. As a reminder, we earn a 9% royalty on sales of Filspari. Other major contributors to royalty revenue this quarter include Giaz's Riley's, with reported Q2 sales of $107.8 million, and Merck's Vax Nubanz, with reported sales of $189 million. 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. Cactus All sales were $7.5 million in the second quarter of 2024, versus $5.2 million in the prior year quarter. with the increase due to timing of customer orders. Contract revenue this quarter was $10.9 million and is due primarily to the three product approvals this quarter, namely the $2.3 million milestone payment earned from the European approval of Filspari, the $5.8 million earned from the approval of Altuveir, and the $2 million earned from the approval of Cabaxi. Moving on to operating expenses, R&D expenses decreased from $6.9 million in the prior year quarter to $5.4 million in Q2 24, with the decrease driven primarily by lower headcount related expenses resulting from last year's Pelican business spinout. G&A expenses increased from $11.3 million in the prior year quarter to $17.6 million in Q2 24. The $6.3 million increase is driven primarily by the $4.7 million investment made to incubate the Pelto's 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 $26.5 million recorded to financial royalty asset impairment is primarily attributable to the reduction in the carrying value of our investment in Takeda's staticless debt as a result of the phase three results recently announced by Takeda that was previously discussed by Paul. The $32 million recorded to other expense is primarily related to the non-cash decrease in the carrying value of our Primrose Bio investment. Our equity ownership interest in Primrose Bio has decreased from 49.9% to 34.3% in connection with a recent financing round. The financing round was at a valuation 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. Gap net loss in the second quarter of 2024 was $51.9 million, or $2.88 per share, versus gap net income of $2.3 million, 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 Statiklostat 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 second quarter of 2024 was $25.8 million, or $1.40 per diluted share, versus $11.7 million, 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 million, which includes $53 million of our holdings in Viking common stock. 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 $15.2 million unrealized gain associated with the Caller Option Agreement in Q2 24, 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 million and now have $125 million available to us under that credit facility. Turning now to guidance under slide 19. As mentioned earlier, we are reaffirming the updated 2024 financial guidance we gave on July 8th in conjunction with the Appiron acquisition announcement. We expect 2024 royalty revenue will be in the range of $100 to $105 million, sales of Captisol in the range of $25 to $27 million, and contract revenue in the range of $15 to $25 million. These revenue components result in total revenue guidance of $140 million to $157 million and adjusted earnings per diluted share of $5 to $5.50. Year to date, we've recorded total revenue of $73 million 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 second quarter earnings press release issued earlier today, including a reconciliation of GAAP results to the adjusted financial results, which is available on our website. I'll now turn the call over to Todd for closing comments.
spk00: Thank you, Thabo. I want to thank everyone for joining us today. We've made tremendous progress at Ligand in the first half of 2024. Ligand has a scalable business model and an efficient, low-cost infrastructure. We continue to grow our portfolio of royalty-generating assets. 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.
spk02: Thank you. We will now begin the question and answer session. If you have dialed in and would like to ask a question, please press star 1 on your telephone keypad to raise your hand and join the queue. If you would like to withdraw your question, simply press star 1 again. If you are called upon to ask a question and are listening via loudspeaker on your device, please pick up your handset and ensure that your phone is not on mute. when asking your question. And your first question comes from the line of Matt Hewitt of Craig and Hallam. Please go ahead.
spk06: Are you there, Matt?
spk02: Mr Matthew it.
spk09: Yes, can you hear me.
spk00: gotcha yeah.
spk09: Okay, well, congratulations on an active quarter, maybe first up, starting with the pencils 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?
spk00: Thank you, Matt. Yes, we have several tangible discussions ongoing in parallel, ranging from straight financing options, which would 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, and we will not rush it. But we're pretty confident that we'll have success in our efforts to spin this out. And, you know, I would say the process and the progress is going very well.
spk09: Excellent. And then maybe one for me and one more, and then I'll hop back into Q. But regarding Carziba, how should we be thinking about the growth of that asset? 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.
spk07: Yeah, so great question. This is Paul. I'll take that head on. So for Recordati, this is a growth asset. I think if you go to their earnings, the most recent earnings announcement, their oncology franchise put up net revenue of 117 million euros, which was growing at a rate of 22.7%. And they said that was mainly driven by Carziba with continued growth of Sylvant, 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 seven years, but it continues to penetrate new territories and regions. In fact, just last month, they secured an approval in South Korea. And we see this growing for the foreseeable future, which is why we were eager to bring it into the LIGAN portfolio.
spk08: And then I would just add, if you want to take a look at slide five, we do have that layered into our longer-term outlook, if you want to get a sense. for our view on that royalty screen.
spk09: Got it. All right. Thank you very much. Congratulations on the strong quarter. Thank you.
spk02: Your next question comes from the line of Douglas Neame of RBC Capital Markets. Please go ahead.
spk03: Yeah, good afternoon. A couple questions. First one, maybe if you could talk about H224 the outlook and maybe sizing of potential deals that you're contemplating. I believe you'd like to spend 200, maybe 250 million a year for these investments. And I'm just wondering if, you know, we're thinking about things in the range of 25 to 75 through to the end of 2024. Yeah, sure. I believe this is Todd speaking, but
spk00: 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 million per year. And that's what we're planning on. There can be some variation around that. And of course, the more recent investment It was a fairly large one at 100 million, although it's cash generated 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 to $40 million 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 discussions go. But I think that's a good, you know, expectation.
spk03: OK, that's great. Thank you. And then as you look at the new product O2 there 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. I'm curious, that royalty, the $13.8 million or milestone, should come in in Q3. Would that be fair?
spk08: Yes, we've got that factored into our forecast, contract revenue forecast for the year. And the company, Verona, has said that they do plan to launch. And if it's not in Q3, probably likely in Q4.
spk03: Yeah. 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. Thank you.
spk00: Yeah, I think, you know, 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 Tavo can give you the estimates, but in the second half of the year, we should be close to $50 million of new cash flow generation, over 100 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. We have plenty of runway from where we are right now.
spk08: 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 million a year at this point.
spk02: Your next question comes from the line of Joe Pankinis of HG Wainwright and Company. Please go ahead.
spk06: Hi. This is Josh. I'm for Joe. Thanks for taking our questions. So, as CapitaBall 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.
spk08: Yeah, 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 capsaicin for their research needs. Thank you.
spk06: Was there a second portion of that question that I didn't address? Just about the BDF for inbound and outbound.
spk00: Yeah, so I would say that there's a steady pace of deal flow around the cap is all business. We are conducting a strategic review there and looking at different ways to accelerate that, expand the business, et cetera. So that's part of our, you know, we spent the first half of 23 really building out the investment team and the second half commencing the execution through till now. And there's a significant operational focus right now in terms of, are we really using best practices in terms of new deal generation around our platform technologies, in terms of monetizing existing assets that we have on our platforms? For example, the nitric oxide platform that we purchased, we're very focused on the Zell Souvenir 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.
spk06: Awesome. Thank you. I appreciate it.
spk02: Your next question comes from the line of Balaji Prasad with Barclays. Please go ahead.
spk04: Good afternoon. This is Xiao Ang for Balaji. Thanks for taking our question. The question is about Capvaxi. Based on the chart on slide 16, seems like you guys are expecting a relatively rapid uptake from 2024 to 2026 with around 500 million annual sales in year 2026. So with that, Would you give us a ballpark range on how much of this asset could drive your royalty revenue growth for the next three years? And would vaccine events a good benchmark to consider? Thanks.
spk08: Yeah, I guess I would want to first say that the chart there that you referenced, those are analyst consensus numbers. And then if you want to get a sense for how we think how that plays out on the top line royalty revenue stream going out to 2028, I would just refer you to slide five. Got it.
spk02: Your next question comes from the line of Larry Salo with CJS. Please go ahead.
spk05: 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 million of the royalty that's from the PI run acquisition, and then there's timing, I mean, not timing, there's the milestone payments for the remainder, right? Basically, essentially, is that correct? That's right.
spk08: You got that right, Larry. Yep.
spk05: 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 five times royalty. And it sounds like it's not there's some it's growing and doesn't include the US which could potentially accelerate growth. Just curious on, you know, how this asset came about sourcing of it. What not it's, you know, without without divulging any, any secret sauce, but just curious if there's anything you could share.
spk00: Yeah, 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.
spk07: That's a great question. I guess in short, it was a 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. 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, you know, cross-border transactions came into play. So, it just made a lot of sense. And there are some future earnouts that were referenced in the press release. And so, really, we're happy to be the proud owners of IRON.
spk05: Got it. Great. If I could just just switch gears and squeeze one more in just on the on the cat back to just another follow up question on that. Again, not looking at the slide as an exact science, but it looks like based on what that new event is today and and my limited knowledge on this market, is this the pneumococcal vaccine, the market in general, right? 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 ACIP recommendation a change from what historical or standard of care is today? That's it. Thanks.
spk08: Yeah. I mean, I can give you my perspective on Beck's new van, formerly known as B114. And so that program is trending towards blockbuster status with Merck. Capvaxif, you know, we're not quite sure how the dynamics will play out there with the existing product. Pfizer's Prevnar, clearly the market leader, I think, you know, 6 to 7 billion market there. And so, you know, analysts expect Capvaxif to, as we show on the chart there, to eclipse the billion-dollar mark as well. So we're excited about that. that royalty stream coming in the future, but it's still early.
spk05: Okay. Great. Thank you.
spk02: Again, if you would like to ask a question, press star, then the number one on your cell phone keypad.
spk00: If there are no more questions, I'll wrap up. Okay. Thank you everyone for joining today's call. We look forward to updating you on our company progress in the next quarterly call in November.
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