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Nippon Shinyaku (4516) 01 September 2016 Asia Pacific/Japan Equity Research Specialty Pharmaceuticals (Pharmaceuticals (Japan)) / MARKET WEIGHT Nippon Shinyaku (4516 / 4516 JP) Rating OUTPERFORM* Price (31 Aug 16, ¥) 4,795 INITIATION Target price (¥) 6,300¹ Chg to TP (%) 31.4 Early entry into niche indications paying off Market cap. (¥ bn) 323.65 (US$ 3.13) Enterprise value (¥ bn) 302.35 ■ Initiating coverage at OUTPERFORM with target price of ¥6,300 Number of shares (mn) 67.50 Free float (%) 55.0 (potential return 31%): We expect Nippon Shinyaku to be the next 52-week price range 5,960 - 3,760 Japanese pharmaceutical company to benefit from the global launch of *Stock ratings are relative to the coverage universe in each Uptravi (selexipag), an internally-discovered drug of blockbuster calibre; and analyst's or each team's respective sector. a strong partnership. The company shifted focus to niche indications almost ¹Target price is for 12 months. a decade ago, and this strategy is on its way to paying off, in our view. Research Analysts ■ Uptravi (selexipag) the biggest driver: Selexipag was originally Yen Ting Chen, PhD 81 3 4550 9936 discovered by Nippon Shinyaku and ex-Japan rights licensed to Actelion. In [email protected] January 2016, selexipag was launched in the US market for pulmonary Fumiyoshi Sakai arterial hypertension (PAH) followed by Germany in June. We forecast peak 81 3 4550 9737 sales of $1.65bn globally, with ¥17.5bn in Japan for the PAH market. With [email protected] additional revenue from royalties and manufacturing, we expect total revenue from selexipag to reach ¥39bn for Nippon Shinyaku in FY3/21. ■ NS-065, possibly an underdog in DMD treatment: Drugs for Duchenne's muscular dystrophy (DMD) are having difficulty gaining approval by the FDA, but with strong interest in this drug class and lack of competition in Japan, we believe easier domestic approval may be possible. A best-case scenario of approval in both countries could lead to additional 8% increase in revenues in FY3/21. ■ Valuation: Our ¥6,300 target price is based on DCF using a 5.1% WACC (risk-free rate 0%, ERP 6.75%, beta 0.77, cost of debt 3%) and 0% terminal growth rate. Risks to our assumption include weak global penetration of selexipag, faster-than-expected generics erosion in Japan, pricing, and setbacks in clinical development. Key catalysts for the upcoming year are quarterly progress of selexipag sales by Actelion, Japan approval and price listing of selexipag in 3Q and 4Q, respectively. Share price performance Financial and valuation metrics Year 3/16A 3/17E 3/18E 3/19E Price (LHS) Rebased Rel (RHS) Sales (¥ bn) 84.2 95.6 97.6 104.5 6000 180 Operating profit (¥ bn) 8.5 13.5 12.3 17.7 5000 Recurring profit (¥ bn) 9.0 13.8 12.6 18.0 4000 130 Net income (¥ bn) 6.3 9.6 8.8 12.6 3000 EPS (¥) 94.1 142.5 130.6 187.0 2000 80 Sep-14 Jan-15 May-15 Sep-15 Jan-16 May-16 Change from previous EPS (%) n.a. IBES Consensus EPS (¥) n.a. 143.6 178.8 242.6 The price relative chart measures performance against the EPS growth (%) 7.8 51.4 -8.3 43.2 TOPIX which closed at 1329.54 on 29/08/16 P/E (x) 46.8 33.7 36.7 25.6 On 29/08/16 the spot exchange rate was ¥103.34/US$1 Dividend yield (%) 0.64 0.73 0.73 0.96 EV/EBITDA(x) 25.1 18.6 19.8 14.2 Performance over 1M 3M 12M P/B (x) 3.0 3.0 2.9 2.6 Absolute (%) -14.5 -17.8 12.3 ROE(%) 6.5 9.3 8.0 10.7 Relative (%) -16.8 -17.2 21.6 Net debt/equity (%) net cash net cash net cash net cash Source: Company data, Thomson Reuters, IFIS, Credit Suisse estimates. DISCLOSURE APPENDIX AT THE BACK OF THIS REPORT CONTAINS IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS, LEGAL ENTITY DISCLOSURE AND THE STATUS OF NON-US ANALYSTS. US Disclosure: Credit Suisse does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the Firm may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report as only a single factor in making their investment decision. CREDIT SUISSE SECURITIES RESEARCH & ANALYTICS BEYOND INFORMATION® Client-Driven Solutions, Insights, and Access 01 September 2016 Table of contents Key charts 3 Investment thesis 4 Early strategic shift to rare and niche indications 6 Selexipag the largest growth driver 8 Pipeline features two other products to drive growth after FY3/19 launch 11 Valuation 14 Risks 16 Earnings forecasts 17 HOLT analysis 22 Appendix: Brief background on pulmonary arterial hypertension (PAH) 23 Nippon Shinyaku (4516 / 4516 JP) 2 01 September 2016 Key charts Figure 1: We forecast Nippon Shinyaku's revenues to Figure 2: We forecast selexipag to contribute ¥39bn to grow to ¥125bn by FY3/21 revenues by FY3/21 Revenue (¥ Bn) CAGR 150 (%, FY3/16A-FY3/21E) Revenue (¥ Bn) 50 125.3 Total 8.2% 114.2 39.6 120 14.7 104.5 Functional food 1.2% 40 95.6 97.6 14.5 0.7 84.2 14.3 9.5 90 76.5 80.0 13.9 14.1 28.6 13.7 30 13.2 13.7 60 19.8 7.0 11.7 110.6 Pharmaceuticals 9.4% 99.7 90.2 20 81.7 83.5 70.5 11.5 5.1 8.6 30 63.3 66.3 11.0 5.2 10 3.1 17.7 6.0 2.6 13.0 0 9.5 4.9 5.8 FY3/14A FY3/15A FY3/16A FY3/17E FY3/18E FY3/19E FY3/20E FY3/21E 0 FY3/17E FY3/18E FY3/19E FY3/20E FY3/21E Additional indications (Japan) API manufacturing PAH (Japan) Milestone & royalties Source: Company data, Credit Suisse estimates Source: Company data, Credit Suisse estimates Figure 3: Nippon Shinyaku pipeline Figure 4: Key events in FY3/17–18 Launch Peak sales Product Indication Market Status year (¥ mn) Product Event FY3/17 Q3 Japan approval Pulmonary arterial hypertension Japan Filed 2016 17,300 Selexipag FY3/17 Q4 Price listing Chronic thromboembolic pulmonary selexipag Japan Phase 3 2020 2,400 hypertension (CTEPH) FY3/17 Q4 ASH conference Atherosclerosis obliterans (ASO) Japan Phase 2 2021 2,700 Presentation of GOYA and Obinutuzumab GALLIUM results GA101 Indolent Non-Hodgkin's lymphoma Japan Phase 3 2018 3,900 FY3/18 Q2 Japan filing Japan Phase 1/2 2018 4,900 NS-065 Duchenne's muscular dystrophy FY3/17 Q4 ASH conference US Phase 2 2019 9,000 NS-018 Presentation of Phase 1/2 study results NS-018 Myelofibrosis US Phase 1/2 2020 1,500 NS-065 FY3/18 Q3 Trial completion Prulifloxacin Bacterial infections China Filed 2016 - NS-580 Endometriosis Japan Phase 1 - - ASH: American Hematology Society Source: Company data, Credit Suisse estimates Source: Company data, Credit Suisse estimates Figure 5: Nippon Shinyaku has the second highest Figure 6: P/E of 44x (based on FY3/17 EPS) is historically forward three-year EPS CAGR (26%) after Ono in line with top performing peers ＝ Forward P/E ratio 60 Avg 3-yr EPS CAGR 2.8% P/E trend of Nippon Shinyaku & top performers (x) P/E ratio (x) Eisai 160 50 140 Takeda 40 120 Nippon Shinyaku 100 Otsuka HD 30 80 Arithmetic mean P/E=23.6 20 60 Shionogi Ono 40 10 20 Jul-14 Oct-14 Jan-15 Apr-15 Jul-15 Oct-15 Jan-16 Apr-16 Jul-16 Nippon Shinyaku Ono Kyowa Hakko Kirin Chugai 0 -20% -10% 0% 10% 20% 30% 40% 50% EPS 3-yr CAGR Source: Company data, I/B/E/S, Credit Suisse estimates Source: Company data, Credit Suisse estimates Nippon Shinyaku (4516 / 4516 JP) 3 01 September 2016 Investment thesis Early strategic shift to rare and niche indications In the challenging Japanese pharmaceutical industry facing new price containment measures and government-supported generics penetration, Nippon Shinyaku took a unique strategy for a Japanese company by shifting focus to rare and niche indications. Through a series of in-licensing deals, it has essentially revamped its product portfolio and fended off generic erosion. Furthermore, we expect the company's key assets, selexipag for pulmonary arterial hypertension (PAH) and NS-065 to be key growth drivers in the near and medium term. Selexipag key growth driver, contributing 32% of revenues in FY3/21 Pulmonary arterial hypertension (PAH) is a rare disorder with a poor prognosis. It involves high blood pressure in the arteries that carry blood from the heart to lungs, which reduces the patient's ability to perform physical activities, and can lead to heart failure We expect selexipag to contribute ¥39bn in annual revenues for Nippon Shinyaku in FY3/21 in three ways: (1) commercialization in the Japanese market for PAH, (2) royalty payments based on global sales from their partner, Actelion, a Swiss company and one of the global leaders in PAH therapy, and (3) manufacturing of the selexipag active pharmaceutical ingredient (API) for Actelion. With robust data from a large phase 3 clinical study, and convenient twice-per-day dosing, we believe selexipag has blockbuster potential (drugs that can achieve over annual sales of $1bn US), with peak sales forecast of $1.65bn globally, with ¥17.5bn in Japan. Pipeline features two other products to drive growth after FY3/19 launch We identify NS-065 and obinutuzumab as the next drugs in the pipeline to contribute to Nippon Shinyaku's revenues NS-065: This drug is an exon-skipping antisense oligonucleotide for Duchenne's muscular dystrophy (DMD).
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