Nippon Shinyaku Co., Ltd. · TSE:4516
Nippon Shinyaku — Investor Presentation (February 2025)
19 slides from Nippon Shinyaku's investor presentation, Feb 18, 2025
Slide 1: FY2024 Small Meeting
FY2024 Small Meeting February 18 th, 2025 Nippon Shinyaku Co., Ltd.
Slide 2: Agenda
AGENDA Introduction 01 Toru Nakai Representative Director, President 02 Q&A 2
Slide 3: Our target for new product launch
Our target for new product launch Modified from May 27, 2024 The 7th Five-Year Medium-Term Management Plan (FY2024 - FY2028) -For Global Growth Beyond the Cliff- Within the period of this plan, we plan to launch an average of at p.26 least two new products per year. We aim to acquire at least one in
Slide 4: Capital allocation: Investment for growth
Capital allocation Develop a capital allocation and make strategic investments necessary for sustainable growth while ensuring financial soundness. cash resource allocation R&D expenses Active investment to promote Investment for growth global development 5-year operating CF 190 billion yen Maximize
Slide 5: Establishing a Foundation for Growth Overcoming the Patent Cliff
Establishing a Foundation for Growth Overcoming the Patent Cliff The patent of Uptravi, which has supported Nippon Shinyaku‘s growth, will expire in FY2027, and royalty revenue, which accounts for the majority of revenues from the licensing of industrial property rights, are expected to decline sign
Slide 6: Safe Harbor Statement
Safe Harbor Statement • Materials and information provided during this presentation may contain so-called “forward-looking statements.” These statements are based on current expectations, forecasts and assumptions that are subject to risks and uncertainties which could cause actual outcomes and resu
Slide 7: Presentation transcript: new product launch targets
Nakai: I am Toru Nakai, President of NIPPON SHINYAKU CO., LTD. From here, we will hold a small meeting inviting sell-side analysts. First, I will pick up some of the slides that I presented during the briefing on the Seventh Medium-Term Management Plan and explain them again, followed by a Q&A sessi
Slide 8: Transcript: basic policy for capital allocation
This slide shows the basic policy for capital allocation during the Seventh Medium-Term Management Plan period. Our policy is to ensure financial soundness, including the sale of policy shareholdings and borrowing as necessary, and to aggressively make the strategic investments necessary for our sus
Slide 9: Transcript: operating profit transition under the plan
Here is an image showing the transition of operating profit during the Seventh Medium-Term Management Plan period. Uptravi, which has supported our growth, will go off patent in FY2027, and royalty revenue from overseas sales of Uptravi is expected to decline significantly. In the DMD area, we expec
Slide 10: Q&A summary
FY2024 Small Meeting for Sell-Side Analysts Q&A (summary) February 18, 2025 No. Question Answer 1 You mentioned previously that you have set aside 100 billion yen as a flexible We management team prepared for the possibility of losing in some license cash allocation for the 7th Five-Year Medium Term
Slide 11: Q&A: differences from the May medium-term plan
2 Today's presentation by President Nakai referred to the briefing on the MT As you pointed out, we had expected that operating income would reach its lowest Plan held in May last year, but I think there were two points where he point around fiscal 2026 and then start to rise again. One of the point
Slide 12: Q&A: operating margin and Viltepso sales
5 Is it achievable, including the profit margin? With Viltepso sales remaining flat, In Asia, we only have our own distribution function in China, and sales of the RGX- you have also acquired the exclusive development and distribution rights for 121/111 in Asia are not yet included in our MT forecas
Slide 13: Q&A: Viltepso patients and accelerated approval
8 In Japan, the number of patients with Viltepso has already reached a plateau, I personally think that sales could be increased a little more. NS Pharma's (NSP) but if gene therapy becomes available, the number of patients with Viltepso commercial team has also started to focus on preparations for
Slide 14: Q&A: DMD specialists' reaction in the U.S.
14 What was the reaction of the DMD specialists in the U.S. when President Physicians who are prescribing Viltepso seem to be thinking about the results of Nakai met with during his business trip there? What about the intention to Study 301 separately from their own experiences of its effectiveness
Slide 15: Q&A: R&D strategy and Sarepta
16 Can you change your R&D strategy flexibly in response to future We will think in a flexible, dynamic way. developments, while keeping an eye on Sarepta's moves? 17 Why do you think Sarepta has stopped developing exon-skipping drugs? Is it Conventionally, exon-skipping drugs or gene therapy drugs
Slide 16: Q&A: CAP-1002 patient numbers in the U.S.
18 Through pre-marketing activities, did you understand the number of patients We plan to disclose sales and expenses forecasts at the appropriate time in the waiting for CAP-1002 in the U.S.? future. We conducted a survey of U.S. payers regarding their willingness to reimburse CAP-1002 and their pr
Slide 17: Q&A: HOPE-3 study and reimbursement trends
21 I would like to ask about the HOPE-3 study for CAP-1002. Since the You are right. They are proceeding with the test by simply increasing the number bioequivalence of the drugs at the manufacturing facilities in Los Angeles and of subjects. San Diego was proven in the non-clinical study, is the ai
Slide 18: Q&A: mucopolysaccharidosis and RGX-121/111
24 Can the same be said about mucopolysaccharidosis? In the treatment of Mucopolysaccharidosis, we aim to have patients become enzyme replacement therapy-free by having them use the gene therapy RGX- 121/111 before enzyme replacement therapy. By showing data in the future of patients who were on enz
Slide 19: Q&A: insurance reimbursement and RGX-121 patients
28 I would like to ask about insurance reimbursement. I heard about a case Patients in the P1/2/3 clinical study for RGX-121 are between 4 months and 5 where insurance reimbursement was rejected for a patient who had lost years old. ambulation and was being treated with Viltepso. In a disease where
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