Chugai Pharmaceutical Co., Ltd. · TSE:4519
Chugai Pharmaceutical — H1 2018 Earnings Presentation
41 slides from Chugai Pharmaceutical's earnings presentation, Jul 26, 2018
Slide 1: Aiming to Achieve the Mid-term Business Plan IBI 18 - FY2018 Half Year Results
Aiming to Achieve the Mid-term Business Plan “IBI 18” - FY2018 Half Year Results - CHUGAI PHARMACEUTICAL CO., LTD. President and CEO Tatsuro Kosaka July 26/27, 2018
Slide 2: Forward-Looking Statements
- FY2018 Half Year Results - Forward-Looking Statements This presentation may include forward-looking statements pertaining to the business and prospects of Chugai Pharmaceutical Co., Ltd. (the “Company”). These statements reflect the Company’s current analysis of existing information and trends. Ac
Slide 3: FY2018 Half Year Financial Performance
- FY2018 Half Year Results - FY2018 Half Year Financial Performance Strong growth in revenues and operating profit mainly due to increases in exports/ROOI driven by global expansion of Actemra and Alecensa, and one time income from transfer of long-term listed products 2017 2018 2018 Progress billio
Slide 4: Major Achievements in FY2018 Half Year
- FY2018 Half Year Results - Major Achievements in FY2018 Half Year Hemlibra <HA with inhibitors> Approval (EU Feb, JP Mar) / Launch (JP May) <HA without inhibitors> Simultaneous Filling (JP/US/EU Apr), US BTD (Apr) US priority review (Jun) <Q4W administration> Simultaneous Filling (JP/US/EU Apr)
Slide 5: Hemlibra: Steady Progress Resulted in Global Simultaneous Filing and Approval
- FY2018 Half Year Results - Hemlibra: Steady Progress Resulted in Global Simultaneous Filing and Approval ‐ 2015 2016 2017 2018 ‐ Approved: Nov 2017 (US), Feb 2018 (EU), Mar 2018 (JP) HAVEN 1 Phase 3: Inhibitor (adults and adolescents) QW administration Approved: Nov 2017 (US), Feb HAVEN 2 2018 (EU
Slide 6: Tecentriq: Steady Progress of Initial Development Plans During FY2018 Half Year
- FY2018 Half Year Results - Tecentriq: Steady Progress of Initial Development Plans During FY2018 Half Year Achieved launch in Japan for NSCLC 2L, and steadily carried out multiple developments to obtain the additional indication during 2018 half year Cancer Treatment Study Indication Line Results
Slide 7: Key Activities for Further Growth
- FY2018 Half Year Results - Key Activities for Further Growth <Strengthening current core business> Extension of CPR investment (Additional 5 years from 2022） • Accelerate the development of clinical candidates by applying next-generation antibody technologies Construction of a new synthetic re
Slide 8: Extension of CPR Investment
- FY2018 Half Year Results - Extension of CPR Investment 【Accomplishments】 Contributed to create multiple development candidate antibodies such as SKY59, ERY974, and maximized the value of proprietary antibody technologies since its establishment in 2012 【Extended opportunities by antibodies】 Di
Slide 9: Accelerate Innovation by Utilizing Artificial Intelligence (AI)
- FY2018 Half Year Results - Accelerate Innovation by Utilizing Artificial Intelligence (AI) Preferred Networks, Inc. Establishment: March 2014 Main Office: Tokyo, USA (California) Business: Research, development and sales of computer software, hardware, and network focusing on IoT Business
Slide 10: Expected Outcomes by Partnership
- FY2018 Half Year Results - Expected Outcomes by Partnership Continuous creation and delivery of innovative drugs Maximize value in the pharmaceutical value chain, and drastically improve productivity Project candidates AI <Insight search> Creation of new value from non-clinical & clinical da
Slide 11: FY2018 Half Year Results
- FY2018 Half Year Results - FY2018 Half Year Results Steady financial performance against full year plan Development projects progressing as planed Initiate key activities for further growth / upfront investment Steady progress of IBI 18 towards the next mid-term business plan 10
Slide 12: FY2018 2Q Consolidated Financial Overview (IFRS based)
FY2018 2Q Consolidated Financial Overview (IFRS based) CHUGAI PHARMACEUTICAL CO., LTD. Executive Vice President and CFO Toshiaki Itagaki July 26/27, 2018
Slide 13: 2Q Results Summary
FY2018 2Q Consolidated Financial Overview 2Q Results Summary Revenues: 285.1 billion yen (+32.3, +12.8% YoY) • Domestic sales excl. Tamiflu: slight decrease due to impact from HIP revision, although sales of mainstay products continued to grow (-0.3, -0.2%) • Overseas sales: growth of Actemra expo
Slide 14: IFRS and Core Results Jan-Jun
FY2018 2Q Consolidated Financial Overview IFRS and Core Results Jan-Jun (Billions of JPY) Non-Core items Intangible assets: Amortization of intangible assets +0.6 Impairment +4.4 Others: none Core net income attributable to Chugai shareholders 52.2 (Millions of shares) Weighted average number of sha
Slide 15: Financial Overview Jan - Jun
FY2018 2Q Consolidated Financial Overview Year on Year (Core) Financial Overview Jan - Jun (Billions of JPY) Royalties and other operating income +13.6 one-time income from transfer of long- listed products on HIP list, etc. Other financial income (expense) +0.2 Exchange gains/losses +1.0 Gains/Loss
Slide 16: Sales (excl. Tamiflu) Jan - Jun
FY2018 2Q Consolidated Financial Overview Year on Year Sales (excl. Tamiflu) Jan - Jun Sales by Disease Area, Sales by Products, Year on Year Comparisons Year on Year Changes (Billions of JPY) 247.2 +18.5, +8.1% 228.7 Rituxan Actemra -3.5, -22.7% (11.9) (overseas) (44.9) +13.8, +44.4% Overseas 64.5
Slide 17: Tamiflu Sales Trends
FY2018 2Q Consolidated Financial Overview Tamiflu Sales Trends * from Jul. 2017 to Jun. 2018 16
Slide 18: Operating Profit Jan - Jun
FY2018 2Q Consolidated Financial Overview Year on Year (Core) Operating Profit Jan - Jun (Billion of JPY) M&D R&D Royalties and -1.0 G&A other operating -1.6 -0.6 income +13.6 Gross profit from sales +11.0 Increase in gross profit from sales +11.0 71.6 Increase in export to Roche and improvement of
Slide 19: Financial Overview Apr - Jun
FY2018 2Q Consolidated Financial Overview Year on Year (Core) Financial Overview Apr - Jun Increase in gross profit from sales +7.1 Increase in export to Roche and improvement of cost of sales ratio to sales Decrease in royalties and other operating income -1.8 Decrease in milestone income Increase/
Slide 20: Financial Progress Jan - Jun
FY2018 2Q Consolidated Financial Overview vs. Forecast (Core) Financial Progress Jan - Jun Cost of sales ratio vs. Sales 2018 2018 Jan – Jun Jan – Dec Actual Forecast 50.3% 50.6% Exchange rate (JPY) 2018 2018 Jan – Jun Jan – Dec Actual* Assumption 1CHF 112.52 115.00 1EUR 131.59 133.00 1USD 108.74 11
Slide 21: Sales Progress (excl. Tamiflu) Jan – Jun
FY2018 2Q Consolidated Financial Overview vs. Forecast (Core) Sales Progress (excl. Tamiflu) Jan – Jun *1 Jan - Jun progress versus Jan – Dec. *2 Forecast for Tecentriq was officially announced on April 24, 2018. *3 Forecast for Hemlibra (domestic sales) was officially announced on July 26, 2018 20
Slide 22: Impact from Foreign Exchange
FY2018 2Q Consolidated Financial Overview vs. Forecast (Core) Impact from Foreign Exchange FX impact Jan – Jun 2018 [Reference] (Billions of JPY) Historical exchange rate to the JPY (FX impact vs. Assumption) Forecast rate JPY 2018 EUR 2018 CHF 2017 EUR 2017 CHF -0.3 140 1EUR: 133JPY 135 Revenues Sa
Slide 23: Balance Sheet Items
FY2018 2Q Consolidated Financial Overview vs. 2017 Year End Balance Sheet Items < Assets, Liabilities, and Net Assets > Decrease in net working capital -4.4 Decrease in trade accounts receivable -7.9 Increase in trade accounts payable -7.8 Increase in other net working capital +10.2 *1 Increase in l
Slide 24: Net Cash
FY2018 2Q Consolidated Financial Overview vs. 2017 Year End Net Cash (Billions of JPY) Total Operating profit after adjustment +80.4 investment Corporate +2.9 income tax Operating profit +66.6 Decrease -17.5 payable, etc. Dividends Depreciation and impairment for property, plant +7.4 in net -15.0 an
Slide 25: Overview of Development Pipeline
Overview of Development Pipeline CHUGAI PHARMACEUTICAL CO., LTD. Executive Vice President Co-Head of Project & Lifecycle Management Unit Dr. Yasushi Ito July 26/27, 2018
Slide 26: Projects under Development (1)
Overview of Development Pipeline Projects under Development (1) (as of July 26, 2018) Phase I Phase II Phase III Filed CKI27 RG6268 / RG3502 / Kadcyla RG7446 / Tecentriq RG1273 / Perjeta (Japan / overseas) entrectinib - breast cancer - NSCLC (adjuvant) - breast cancer - solid tumors - NSCLC ★ - SCLC
Slide 27: Projects under Development (2)
Overview of Development Pipeline Projects under Development (2) (as of July 26, 2018) Phase I Phase II Phase III Filed RG7845 / fenebrutinib MRA (RG1569) / Actemra - rheumatoid arthritis - systemic sclerosis Autoimmune SA237 (RG6168) / satralizumab - neuromyelitis optica★ RG7935 / prasinezumab RG791
Slide 28: Development Status (1)
Overview of Development Pipeline Development Status (1) In- house ACE910 / Hemlibra® Routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients with hemophilia A with factor VIII inhibitors Launched in May 2018 (JP) Routine prophylaxis to prevent or r
Slide 29: Development Status (2)
Overview of Development Pipeline Development Status (2) In- licensed RG7159 / Gazyva® CD20-positive follicular lymphoma Approved in July 2018 In- licensed RG7446 / Tecentriq® Head and neck carcinoma (adjuvant) Started global Phase 3 study in June 2018 In- licensed RG6268 / entrectinib ROS1 fusion ge
Slide 30: Development Status (3)
Overview of Development Pipeline Development Status (3) In- licensed RG6264 / Herceptin® and Perjeta® HER2 positive breast cancer (Fixed-dose combination, subcutaneous injection) Started global Phase 3 study in July 2018 In- licensed RG7604 / taselisib Solid tumors Development discontinued In- house
Slide 31: Other Progress (1)
Overview of Development Pipeline Other Progress (1) In- AF802 / Alecensa® house ALK positive advanced NSCLC (1L) Approved in May 2018 (Taiwan) In- MRA / Actemra® house Cytokine release syndrome induced by treatment with CAR-T cell therapy Filed in May 2018 (JP) Recommendation for approval granted in
Slide 32: Other Progress (2)
Overview of Development Pipeline Other Progress (2) In- RG1450 / gantenerumab licensed Early Alzheimer’s disease Started global Phase 3 study (GRADUATE1) in June 2018 FMI Activities towards commercialization of Foundation business Medicine’s products in Japan FoundationOne CDx™ PMDA granted Expedite
Slide 33: Results of Clinical Trials / Conference (1)
Overview of Development Pipeline Results of Clinical Trials / Conference (1) In- house ACE910 / Hemlibra® Hemophilia A Data from two global Phase III studies presented at WFH 2018 World Congress HAVEN 3: without factor VIII inhibitors HAVEN 4: Q4W administration (with/without factor VIII inhibit
Slide 34: Results of Clinical Trials / Conference (2)
Overview of Development Pipeline Results of Clinical Trials / Conference (2) In- licensed RG7446 / Tecentriq® Metastatic triple negative breast cancer (1L) • Global Phase 3 study, IMpower130 met one of the co-primary endpoints (PFS) in July 2018 Statistically significant improvement in PFS with th
Slide 35: Chugai's Portfolio in Lung Cancer
Overview of Development Pipeline Chugai’s Portfolio in Lung Cancer Positive Data: CP = carboplatin + paclitaxel; CnP = carboplatin + nab-paclitaxel Conceptual illustration: Modified from Roche Analyst Event slides at ASCO 2018 34
Slide 36: RG6268 (entrectinib) and its Mode of Action
Overview of Development Pipeline RG6268 (entrectinib) and its Mode of Action The right drug for the PHC 2.0 strategy right patient by comprehensive NGS Entrectinib Entrectinib is under development that represents the PHC 2.0 strategy promoted by the Roche group. Entrectinib is an orally bioavailable
Slide 37: Personalized Health Care in Cancer Immunotherapy
Overview of Development Pipeline Personalized Health Care in Cancer Immunotherapy ~Moving from All Comer Trials to Disease-specific Diagnostics Subsets~ PD-L1 • Measure PD-L1 expression in cancer tissues and intracellular domains by IHC tests expression (IHC) • Diagnostics used to support decision-m
Slide 38: B-F1RST: Expectation for Blood-based Biomarker, bTMB on NSCLC (1L)
Overview of Development Pipeline B-F1RST ：Expectation for Blood-based Biomarker, bTMB on NSCLC (1L) Atezolizumab PFS by bTMB subgroups ORRb by b bTMB subgroups s Velcheti V, et al. ASCO 2018 Data cutoff: December 7, 2017 Interim analysis results: bTMB enriches for PFS benefit of atezolizumab in 1L N
Slide 39: Projected Submissions (Post PoC NMEs and Products)
Overview of Development Pipeline Projected Submissions (Post PoC NMEs and Products) Filed NME line extension in-house PERJETA TECENTRIQ in-licensed (RG1273) (RG7446) Breast Cancer NSCLC (1L) NSCLC: non-small cell lung cancer (adjuvant) RCC: renal cell carcinoma HEMLIBRA SCLC: small cell lung cancer
Slide 40: Updates on the Development Requests for Unapproved Drugs/Indications
Overview of Development Pipeline Updates on the Development Requests for Unapproved Drugs/Indications Review Committee of Development Requests for Unapproved Drugs/Indication • 1st round requests: all approved (ten indications, including additional dosages and administrations of eight products) • 2n
Slide 41: Contacts: Corporate Communications Dept.
Overview of Development Pipeline Contacts: Corporate Communications Dept. Media Relations Group Tel: +81 (0)3-3273-0881 Fax: +81 (0)3-3281-6607 e-mail: pr@chugai-pharm.co.jp Tomoko Shimizu, Hiroshi Araki, Chisato Miyoshi, Yayoi Yamada Investor Relations Group Tel: +81 (0)3-3273-0554 Fax: +81 (0)3-32
Chugai Pharmaceutical — H1 2018 Earnings Presentation on 6ix