Nxera Pharma Co., Ltd. (4565) Earnings Call Transcript & Summary

Fantastic. Thank you very much. Good afternoon, everyone. Thank you for joining us today. My name is Chris Cargill, I'm the CEO of Sosei Group from Japan. It's my pleasure to give you an overview of our business today and to get you all very excited for the year ahead. And before I begin, just let me turn your attention to the customary disclaimer regarding this presentation and its material here on Slide 2. So at Sosei, we are building the next-generation pharma company for Japan. We're headquartered in Tokyo with our research center based in Cambridge U.K., and we are a fully integrated operation. We're the only homegrown Japanese biotech to be listed on the Tokyo Stock Exchange, the top tier, the prime segment. We are arguably the world leaders in structure-based drug design against GPCR targets. And this innovation ability has helped us build a pipeline of over 30 active programs across CNS, GI, and immunology and inflammation therapeutic areas. And most importantly, our first commercially available product, PIVLAZ, is now protecting the lives of Japanese patients every day. So a little bit about our history. We've taken multiple strategic steps to get where we are today. We started out with Series A and B financing in the '90s, ahead of an IPO in the early 2000s. And our intent has always been clear: we want to build the next-generation pharma company for Japan. In 2005, the acquisition of Arakis brought us royalty income as Nevada successfully commercialized our first partnered programs. In 2015, the acquisition of Heptares gave us the world's leading innovative technology platform for drugging GPCRs, which we have since scaled into a significant pipeline of clinical programs. And most recently, the acquisition of Idorsia's Japanese and Korean business last year gave us our first wholly owned commercial product and the development and commercial capability that we desired in our home market. Now this coming March, we're very excited to be launching a new corporate name and brand identity to crystallize the organization as one integrated business and signify our intent to be that next-generation pharma company for Japan. So our business now spans the entire spectrum from drug discovery to commercialization. Our core focus is on commercializing innovative medicines in Japan and APAC. And we leverage partners to get our medicines to patients in the U.S., EU and rest of world markets. So our highly productive R&D engine generates novel candidates that we take through to the early clinical stages. Now in time, we aim to develop and commercialize these products for Japan and APAC as well. We bolstered this in-house pipeline for Japan and APAC with in-licensed and/or acquired products, and we aim to be the partner of choice for pharma and biotech companies that are looking to get their drugs into patients in Japan. For the U.S. and the EU markets, we collaborate with emerging tech companies to exploit complementary technologies to seed new discovery programs. And for example, some of the companies that we're working with, Verily and Kallyope; and also some established players, Takeda, AbbVie and Lilly. In addition to this, we leverage well-funded pharma partners with specialist capabilities like Pfizer and Neurocrine to develop our potential blockbuster programs for the U.S. and EU markets. So the model is cash flow-generative. It gives us the flexibility to maintain a strong cadence of innovation, and it means we can achieve the best of both pharma diversification with the upside potential of a biotech. So 2023 for us was a very, very transformative year. Arguably, we're one of Japan's most active mid-cap pharma names. We became the first-ever homegrown Japanese biotech to be promoted to the top tier of the Tokyo Stock Exchange, known as the prime segment. We closed the acquisition of Idorsia's Japan and Korean businesses, and we attracted a landmark investment from the Japan government's innovation fund, their first-ever public investment into a domestic health care company. We also expanded our product pipeline with the approval of PIVLAZ in South Korea in December, and we submitted the JNDA for the best-in-class insomnia drug, QUVIVIQ, in Japan. Together with our partners, we had 6 clinical starts in 2023, and our partners continue to advance in major areas of unmet medical need: Neurocrine with its muscarinic programs in the neuropsych space and Pfizer with its oral GLP-1 program for diabetes and obesity. So it was a year of strategic action and investment that positions us really well for future growth. So now let's take a look at what the future holds for Sosei. We have a very simple mission. We like to invest in world-leading science to deliver life-changing medicines for patients. And over the next few slides, I'll talk you through our approaches to cutting-edge science, our pipeline programs by design and our life-changing medicines. But we'll start with life-changing medicines, and I'll work my way back to the cutting-edge science. So as I mentioned at the top, our first commercially available product, PIVLAZ, is now protecting the lives of Japanese patients every day. PIVLAZ is a highly effective, innovative treatment for cerebral vasospasm associated with aneurysmal subarachnoid hemorrhage. Now the drug has a very manageable safety profile and is an attractive new option for neurosurgeons, and it was recently included in the Japanese treatment guidelines for the management of stroke. We are now 7 quarters into the launch of this drug, and PIVLAZ generated JPY 13.4 billion of NHI sales or approximately USD 90 million in its first full year last year. And to date, over 10,300 patients have been treated with the drug in Japan. Now following the MFDS approval that we obtained in Korea in December last year, we also look forward to making PIVLAZ available to South Korean patients for early 2025. And thereafter, we're going to look to extend the product further across the APAC ex China region, and we will be looking to identify local partners to access those markets. Now on to the next product in our pipeline. Sleep disorders have a massive impact on Japanese society. There are huge losses of productivity from absenteeism and sickness in Japan. And of course, there is a high risk of mortality when average sleep levels are less than 6 hours per night. So our next life-changing medicine is a drug called QUVIVIQ. It's a best-in-class dual orexin antagonist for the treatment of patients with insomnia. Our Phase III Japan data demonstrated improved total sleep time, latency for sleep onset and had a favorable safety profile. We filed the JNDA with the Japanese PMDA in late October last year, and we expect a potential approval by the end of 2024 and a rapid launch thereafter with our local co-promotion partner, Shionogi. And QUVIVIQ is already approved in other major markets. As with our lead product, PIVLAZ, our rights to QUVIVIQ extend to the broader APAC ex China territories, and we look forward to identifying partners that can take the product forward and make it available to patients across the APAC ex China area. So now I just want to talk a little bit about our exciting earlier options, our clinical programs by design. So our world leadership in drugging GPCRs has enabled us to generate a very substantial clinical pipeline of potential blockbusters, including being exposed to some of the fastest-growing areas of metabolic disease and neuropsych. Now together with our partners, I mentioned we had 6 clinical starts in 2023, but we're not going to rest here. We expect to start a further 2 Phase I trials in 2024, both first-in-class approaches to treat IBD, which is another area of huge unmet medical need. Now I mentioned on the previous slide that we have clinical exposure to the high-growth area of neuropsych, and this comes via our partnership with Neurocrine. Neurocrine is advancing the most comprehensive portfolio of muscarinic agonist programs for schizophrenia and neuropsychiatric disorders. These compounds were discovered by our scientists, and they were licensed to Neurocrine in late 2021. Muscarinic agonism for the treatment of schizophrenia and psychosis has been validated by Karuna's KarXT, and therefore, Neurocrine's best-in-class approach is expected to receive strong interest throughout this year following the recent deal activity surrounding Karuna and Cerevel. The most advanced program, NBI-568, is a selective M4 agonist being developed as a potential new treatment for schizophrenia. It is currently in Phase II studies. Trial enrollment is going well, and we expect the Phase II top line readout by the end of 2024. In addition to this, Neurocrine initiated Phase I studies of other compounds, notably NBI-570, which is a dual M1/M4 selective agonist; and NBI-569, an M4-preferring agonist that has the potential to treat neurological and neuropsych conditions. So we're very excited at the potential of these medicines. We could not have a better partner than Neurocrine to be advancing them comprehensively through the clinic. So beyond our partnered programs, our next wave of potential blockbuster in-house programs are also advancing. So in 2023, we initiated a Phase I/IIa study of a selective EP4 antagonist for immunosuppression in advanced solid tumors. And this is in collaboration with Cancer Research UK. Cancer patients are now being dosed with this medication, and there have been no dose-lending toxicity issues reported to date. Also in 2023, we initiated a Phase I study of a selective GPR52 agonist, a novel target that presents opportunities in schizophrenia and psychosis. And we are also making good progress with our oral GI-restricted EP4 agonist program for IBD in which we anticipate a Phase I start in the first half of this year. And as we announced late last year, we're actually very fortunate to have another opportunity to advance a potential blockbuster product on an in-house basis as we will soon regain full ownership of our GPR35 agonist program. So this was initially out-licensed to GSK a few years ago. And with a significant amount of investment from GSK to date, it was recently discontinued due to a reprioritization of their immunology pipeline. The GPR35 represents a very exciting first-in-class opportunity to target GI disease. It has an established genetic association to IBD, and preclinical data of this novel first-in-class agonist support the potential to improve gut barrier function and reduce visceral pain hypersensitivity. So the opportunity to address the significant unmet need is very clear. There are no existing therapies that directly address barrier function and pain hyperexcitability. So the program when in GSK's hands had already received U.K. MHRA approval to start a Phase I study. So we look forward to getting it back this year and advancing it into the clinic ourselves. Now beyond our neuropsych and IBD programs and exposure there, we have deep and broad exposure additionally to the high-growth metabolic space, including the fastest-growing area in modern medicine, GLP-1 agonists. So Pfizer used our science and structural insights to enable the discovery of its once-daily oral small molecule GLP-1 program, and this is currently in Phase I. Lilly is using our science and structural insights to enable the discovery of new medicines beyond the GLP-1 target in metabolic diseases. But we also have our own internal next-generation programs in discovery that target receptors upstream with the incretins. Now it's projected that the GLP-1 and GIP medicines for diabetes and obesity could soon create a $100 billion market. But emerging research also suggests that these medicines could benefit heart, liver and kidney diseases. So we're very happy that we have the right partners in place to exploit this very, very large area of opportunity for patients. As I promised you earlier, I said I'd circle back to the cutting-edge science. Now we are not an AI or machine learning company per se. However, our GPCR technology and platform does support the application of AI and machine learning approaches. So we developed AI and ML tools internally, but we also extensively collaborate with expert partners that bring complementary capabilities that accelerate our drug discovery efforts. So we're currently deploying AI and machine learning across 4 areas of R&D as we look to shorten the time lines it takes to generate candidates. So we use in-house-developed algorithms to predict StaR-enabling mutations and GPCR-binding sites. We work with an AI partner in the U.K., PharmEnable Therapeutics, on molecule design to identify and optimize new chemical starting points. And in translational medicine, we partner with PrecisionLife to leverage AI-led analysis of large patient data sets to identify biomarkers and patient stratification strategies for early clinical programs. So we're true believers that AI and ML initiatives will be able to accelerate and enhance all areas of our structure-based drug design platform, which in the medium to longer term will enable us to get our programs into patients faster. So we have the financial capacity to execute on all of our strategic growth initiatives. Following the landmark investment by the Japanese government's innovation arm last year, we closed the period with $350 million or thereabouts cash in the bank. This will enable us to continue to invest in R&D, which also going forward will include aggressively hunting new product opportunities to in-license or acquire for the Japanese and APAC markets where we now have commercial capabilities. So 2024 is shaping up to be a very, very strong year for us with several catalysts that should support value creation. So as you can see here on this slide, there will be a steady stream of clinical starts both by us and our partners. Plus we've got the anticipated Phase II data for Neurocrine's muscarinic M4 agonist program expected by the year-end. And as I mentioned earlier, on the commercial side, we will continue to seek further product approvals and extend into new APAC territories beyond Japan with partners. So we're very, very excited for the year ahead. So in summary, our mission, still in progress, but we will not rest. We are building the next generation of pharma company for Japan, and we have a focus on cutting-edge science, blockbuster programs by design and delivering life-changing medicines. So thank you for your time today.