Nxera Pharma Co Ltd

Time has come, so we will now begin the financial results briefing of Nexera Pharma for the first half of FY 2025. Thank you very much for taking time after a busy schedule to join us today. I'm Nomura, CFO, and I will be the moderator. Today we have Chris Cargill, CEO, and Dr. Matt Barnes, CSO and President of Nexera UK. Simultaneous interpretation is provided. Please click on the language selection icon and select either Japanese or English. If you choose off, you will hear the speaker's original voice. Today, we will explain, as always, the progress of our business using the material in the first half, followed by Q&A session in the second half. The presentation materials will be shown on the screen and are also available on our website. If you want a copy, please enter from the news tab on the website on the left side and access the financial results material. For the Q&A session in the second half, institutional investors, analysts, and members of the media are welcome to raise your hands and ask questions. For all others, please submit your questions via the Q&A button. Questions can be submitted any time during the webinar and will be answered as time permits during the Q&A session. So we will start the briefing. Chris will first explain the operational highlights, then I will explain the first half results and Japan and a pack commercial business, followed by matt on r&d progress, mainly in the UK and, finally, Chris will explain our fyi 2025 goals and medium to long term objectives, please do to page five of the presentation, Chris the floor is yours.

Fantastic. Thank you, Nomura-san. And good afternoon, everyone. I'm Chris Cargill, CEO of Nexera Pharma. Thank you for joining us today for our Q2 2025 results presentation. On slide three, I'll begin by walking you through our operational highlights, and then I'll pass you over to Nomura-san for our financial results and Japan and APAC commercial updates. Lastly, Matt will take us through key progress from our R&D business in the UK, and I'll finish with a strategic outlook for FY 2025 and beyond. So I'm on slide five now. Firstly, let me briefly recap our priority objectives for the full year. So our first objective is to exceed 17 billion Japanese yen in sales for our two key products, PIVLAS and Qvivik. I'm pleased to say that our commercial performance is on track to meet this objective, following a successful first half of the year for PIVLAS and the inclusion of Qvivik, which is progressing well with our partner, Shirogi. For our second objective, we are in active discussions with a number of partners regarding in-licensing late-stage assets for our Japan and APAC business, and I look forward to sharing more progress later on this year. Similarly, for objective three, our business development discussions continue to progress with a range of potential biotech and pharma partners. And we are also expecting, very shortly, to start a Phase 2a study of our wholly owned EP4 antagonist NXE732, and that's together with Cancer Research UK. We're making great progress against our fourth objective as we continue to invest in optimising our internal business systems. And regarding the final objective, we continue to push the GPR52 agonist program forward and will be able to provide an update later this year regarding the timeline for the expected Phase 1b data readout that will support the option exercise decision. So we're focused on prioritizing and accelerating key programs in attractive commercial markets that will create long-term value. And for example, this week we revealed the launch of our comprehensive obesity and chronic weight management pipeline. Please turn to slide six. Now, the first half of this year has seen great progress across our core businesses where we remain extremely productive. We enriched the management team with two new external directors and a new head of IR to enhance transparency and communication with shareholders, particularly in Japan. We simplified our governance structure in Japan, streamlining MPJ structure to a single representative directive, representative director, sorry, Mr. Toshi Maeda. And in our UK R&D business, we've hit several pipeline inflection points. So TMP301, which is our mGlu5 negative allosteric modulator program, partnered with Tempera Bio, is for substance use disorder, and it entered phase two. MBI568, our partnered M4 agonist with Neurocrine, entered a phase three study for schizophrenia. And ORX142, our second OX2 agonist, partner with Sintesa, initiated a phase one study. As I mentioned, we also announced seven new proprietary obesity programs, building out our metabolic disease portfolio, which we will provide further detail on later in this presentation. Now, Pfizer discontinued development of PF522 following a portfolio decision, but we intend to enter discussions with Pfizer regarding potential opportunities to advance GLP-1 molecules discovered through this collaboration. Our Japan and APAC business has seen great progress on the commercial front. As I mentioned, PIVLAS remains the clear market leader for the prevention of cerebral vasospasm in Japan, where sales continue to grow. And following our agreement with with Holling for Daradirection in Taiwan, launch plans are underway for that product in that market from mid-2026. And we also assigned the rights for Sineramod in Japan and APAC to Viatris. And in Korea, we're now exploring non-reimbursed access pathways for PIVLAS following our decision to withdraw from drug price negotiations in Korea. Please turn to slide seven, please. As you can see on this slide, we have a broad and balanced innovative pipeline targeting some of the biggest areas of unmet medical need across three key therapeutic areas, metabolic disease, neurology, and immunology slash GI. Nexera Pharma is well advanced in its mission to accelerate innovative medicines to patients and become one of the leading players in Japanese pharmaceuticals. With two recently launched products driving stable, top line sales growth, plus a pipeline of innovative clinical stage programs, the risk and reward is very attractive. We have the upside potential of a biotech company, but we have the diversification of a commercial pharma business. Please turn to slide eight. So earlier this week, we formally launched our broad new pipeline of programs targeting obesity and chronic weight management. The central to this pipeline is our new wholly-earned oral small molecule GLP-1 agonist program. And this is complemented by six additional innovative programs targeting the GIP, amylin, and apillin receptors. The obesity field is undergoing a shift towards oral therapeutics, and that's driven by patient demand, real world practicalities and payer pressures. And so our internal pipeline was designed to meet this rapidly emerging need. And as shown here, we are one of the few players in active development across all four of these mechanisms, offering significant opportunities beyond the current GLP-1 space. For example, amylin agonists are likely to play a huge part in the emerging treatment landscape for preserving muscle in weight loss. And we're confident that we can achieve significant progress over the midterm, delivering clear value for shareholders and patients in a rapidly expanding obesity market. So I will now pass over to Nomura-san, who will take you through our financial results for the first half of the year and also our commercial performance in Japan. Thank you, Nomura-san.

Chris, thank you very much.