Investor Presentaiton

Made public by

sourced by PitchSend

12 of 32

Creator

PitchSend logo
PitchSend

Category

Pending

Published

Unknown

Slides

Transcriptions

#1Sumitomo Pharma Innovation today, healthier tomorrows Investors Meeting Presentation for FY2022 (Year ended March 31, 2023) Hiroshi Nomura, President and CEO Sumitomo Pharma Co., Ltd. May 15, 2023#2Disclaimer Regarding Forward-looking Statements This material contains forecasts, projections, targets, plans, and other forward-looking statements regarding the Group's financial results and other data. Such forward-looking statements are based on the Company's assumptions, estimates, outlook, and other judgments made in light of information available at the time of preparation of such statements and involve both known and unknown risks and uncertainties. Accordingly, plans, goals, and other statements may not be realized as described, and actual financial results, success/failure or progress of development, and other projections may differ materially from those presented herein. Information concerning pharmaceuticals and medical devices (including compounds under development) contained herein is not intended as advertising or as medical advice. Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 1#3Financial Results for FY2022 Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 2#4Financial Results for FY2022 Financial Results for FY2022 (Core Basis) (Ref.) Earnings related to Sumitovant Billions of yen Billions of yen FY2021 FY2022 Change FY2022 FY21 FY22 Jan. 31 Results Results Value FX impact % Revenue 35.7 89.7 forecasts Revenue Cost of sales Gross profit SG&A expenses R&D expenses Other operating income/expenses Core operating profit Changes in fair value of contingent 560.0 555.5 (4.5) 60.5 (0.8) 563.0 SG&A expenses * 90.3 139.5 157.1 176.7 19.6 18.4 12.5 173.0 R&D expenses 24.3 33.7 402.9 378.8 (24.1) 42.1 (6.0) 390.0 Core operating profit (86.9) (96.8) 251.6 305.6 54.1 39.7 21.5 308.0 Operating profit (86.5) (97.7) 94.0 106.1 12.1 12.7 12.8 98.0 Net profit (87.4) (103.9) 1.2*1 49.2 48.0 4.2 50.0 Net profit attributable to (71.6) (81.7) owners of the parent 58.5 16.4 (42.1) (6.2) (72.0) 34.0 3.3 3.4 0.1 1.0 consideration (negative number indicates loss) Other non-recurring items (negative number indicates loss) (1.6) *2 (96.7) (95.2) Operating profit 60.2 (77.0) (137.2) (27.0) Finance income/costs 22.7 29.1 6.3 Profit before taxes Income tax expenses Net profit Net profit attributable to owners 83.0 (47.9) (130.9) 42.4 48.8 6.4 40.6 (96.7) (137.3) 56.4 of the parent (74.5) (130.9) The figures include intra-group transaction * Include amortization of patent rights (62.0) *1 Breakdown of other operating income/expenses 1 Share transfer of Sumitomo Pharma Food & Chemical 2 Sale of Priority Review Voucher ③ Divestiture of BROVANAⓇ and XOPENEX HFA® 4 Divestiture of LUNESTAⓇ *2 Breakdown of other non-recurring items ①Impairment loss on KYNMOBIⓇ : ¥55.6B 2 Impairment loss on TP-0903 : ¥20.6B (35.0) ③Restructuring expenses in North America : ¥12.7B Average rates: Period end rates: Sumitomo Pharma FY2021 Results: FY2022 Results : FY2022 forecasts: 1US$ ¥112.40, 1RMB = \17.52 1US$ ¥135.51, 1RMB = \19.75 1US$ ¥135.00, 1RMB = ¥19.50 As of the end of March 2022: 1US$ = ¥122.41, 1RMB = \19.26 As of the end of March 2023: 1US$ = ¥133.54, 1RMB = ¥19.42 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 3#5Financial Results for FY2022 Revenue of Major Products in Japan Billions of yen Change FY2021 FY2022 Results Results Value % EquaⓇ/EquMetⓇ 37.5 33.6 (4.0) (10.5) TrulicityⓇ* 33.6 24.8 (8.8) (26.2) TRERIEFⓇ 16.4 16.7 0.3 1.8 Sales collaboration of TrulicityⓇ terminated at the end of December 2022 LATUDAⓇ 6.9 9.6 2.7 39.3 LATUDAⓇ showing steady growth METGLUCO® 8.1 7.7 (0.4) (5.5) LONASEN® Tape 2.1 2.9 0.9 42.8 TWYMEEGⓇ 0.2 2.2 2.0 AG products 9.7 9.2 (0.5) (5.2) Prescription days limit of TWYMEEGⓇ was lifted in September 2022 Others 35.5 19.5 (16.0) (45.1) Total 149.9 126.1 (23.8) (15.9) Sale of REPLAGALⓇ included in "Others" decreased (FY2021: ¥12.4B) Note: Sales of each product are shown by invoice price (* TrulicityⓇ is shown by NHI price) Sumitomo Pharma NHI price revision affected (¥10.9B) the Japan segment total © Sumitomo Pharma Co., Ltd. All Rights Reserved. 4#6Financial Results for FY2022 Revenue of Major Products in North America & China FY2021 Resuts FY2022 Results Change FY2021 Resuts FY2022 Results Value Change FX impact % North America Million $ Billions of yen LATUDAⓇ 1,816 1,465 (351) 204.1 198.5 (5.6) 33.9 (2.8) APTIOMⓇ 241 249 8 27.1 33.7 6.6 5.8 24.4 RETHYMICⓇ 3 33 30 0.3 4.4 4.1 0.8 BROVANAⓇ 129 21 (108) 14.5 2.8 (11.7) KYNMOBIⓇ 5 3 (2) 0.6 0.4 (0.2) 0.5 (80.7) 0.1 (29.1) ORGOVYXⓇ 83 182 99 9.3 24.7 15.4 4.2 164.9 MYFEMBREEⓇ 6 33 27 0.7 4.5 3.8 0.8 528.8 GEMTESAⓇ 63 182 119 7.1 24.7 17.5 4.2 246.0 Others * 498 256 (242) 56.0 34.7 (21.2) 5.9 (38.0) Total 2,845 2,424 (421) 319.8 328.5 8.7 56.0 2.7 China MEROPENⓇ Million RMB Billions of yen 1,708 1,445 (263) 29.9 28.5 (1.4) 3.2 (4.6) Others Total 478 550 72 8.4 10.9 2.5 1.2 29.7 2,186 1,995 (191) 38.3 39.4 1.1 4.4 2.9 * Lump-sum revenue included in "Others" FY2021 Revenue from the alliance with Otsuka of $270M FY2022 Revenue from the license agreement for ORGOVYX® of $50M Milestone revenue from approval of endometriosis of $38M North America segment Revenue increased due to the impact of fluctuations in FX rates and products of Sumitovant and its subsidiaries ■LATUDAⓇ revenue decreased due to a decrease in shipment volume due to the end of the exclusivity sales period in February 2023 and a decrease in selling prices due to changes in the payer mix ■BROVANAⓇ revenue decreased due to loss of exclusivity in June 2021 Revenue from license agreements included in "Others" decreased (See the breakdown below the table) ■ China segment MEROPENⓇ revenue decreased due to the impact of Volume-Based Procurement application FX rates: FY2021 Results: 1US$ = ¥112.40, 1RMB = \17.52 FY2022 Results: 1US$ = ¥135.51, 1RMB = \19.75 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 5#7Financial Results for FY2022 Segment Information (Core Basis) Billions of yen Japan: Lower profit due to declined gross profit North America: Profit decreased since the impact of higher expenses in Sumitovant Group and forex situation exceeded increased revenue China: Profit decreased since the impact of higher expenses in forex situation Other Regions: Profit includes the revenue of $50M under the license agreement for DSP- 0187 Pharmaceuticals Business North Japan China America Other Regions Subtotal Other Business Total Revenue (Sales to customers) 126.1 328.5 39.4 16.8 510.7 44.8 555.5 Cost of sales 65.3 62.4 8.4 5.1 141.3 35.4 176.7 Gross profit 60.9 266.0 31.0 11.6 369.5 9.3 378.8 SG&A expenses 51.8 233.8 11.4 1.6 298.7 7.0 305.6 Core segment profit 9.1 32.2 19.5 10.0 70.8 2.4 73.2 R&D expenses 103.2 2.8 106.1 Core operating profit (8.0)| 24.3 16.4 Revenue (Sales to customers) 149.9 319.8 38.3 12.2 520.2 39.9 560.0 Cost of sales 78.7 33.6 7.4 6.6 126.3 30.8 157.1 Gross profit 71.3 286.2 30.9 5.5 393.9 9.0 402.9 SG&A expenses 51.7 180.8 11.3 2.3 246.1 5.5 251.6 Core segment profit 19.6 105.4 19.6 3.3 147.8 3.5 151.4 R&D expenses 91.7 2.3 94.0 Core operating profit 57.3 1.2 58.5 Revenue (Sales to customers) (23.8) 8.7 1.1 4.6 (9.5) 5.0 (4.5) SG&A expenses 0.1 53.0 0.1 (0.7) 52.6 1.5 54.1 Core segment profit (10.5) (73.1) (0.0) 6.7 (77.0) (1.1) (78.1) R&D expenses Core operating profit 11.6 0.5 12.1 (65.3) 23.2 (42.1) FY2022 Results FY2021 Results Change Sumitomo Pharma Sumitomo Pharma Co., Ltd. All Rights Reserved. 6#8Financial Results for Q4 FY2022 Marketing Status of ORGOVYX® Approx. 5,000 new patients started treatment with ORGOVYX® in Q4 FY2022 (19% growth vs. Q3 FY2022) +19% 31,000 26,000 22,000 18,000 14,500 11,000 8,000 4,500 ■The market for androgen deprivation therapy targeted by ORGOVYX® is over 200 billion yen/year (gross conversion), and recently expanded by approx. 20% annually* ■Established broad health plan coverage (Percentage of coverage obtained as of April 2023: total of Medicare Part D lives was approx. 100%, total of commercial lives was >90%) ■ Gathering new evidence for further potential utility (Use in combination therapy and cardiovascular event Q1 Q2 Q3 FY2021 FY2021 FY2021 FY2021 FY2022 FY2022 FY2022 Q4 Q1 Q2 Q3 Q4 FY2022 risks) Estimated Cumulative Patients Treated with ORGOVYX® (includes patients on free and commercial drug, excludes patients utilizing product samples) *Source IQVIA *NSP sales for RELUGOLIX, DEGARELIX, GOSERELIN, LEUPROLIDE, and TRIPTORELIN for the 12 months ended Feb. 2023 were $1,612M (130yen/$), which reflects a 21% growth vs the 12 months ended Feb. 2022#9Financial Results for Q4 FY2022 Marketing Status of MYFEMBREEⓇ Approx. 19,700 total prescriptions (TRX) in Q4 FY2022 (29% growth vs. Q3 FY2022) +29% 19,783 15,380 10,406 7,664 4,924 2,572 469 Q2 FY2021 Q3 Q4 Q1 Q2 Q3 Q4 FY2021 FY2021 FY2022 FY2022 FY2022 FY2022 Number of prescriptions per quarter with MYFEMBREE®* The market targeted by MYFEMBREEⓇ is approx. 63 billion yen/year (gross conversion), and recently expanded by approx. 20% annually** Also focus on switching from oral contraceptives, NSAIDs, and surgery to MYFEMBREEⓇ Established broad health plan coverage (Percentage of total commercial lives as primary coverage obtained as of March 2023; for UF was >90% and endo. was >80%) ■Gathering new evidence for further potential utility (To leverage data of long-term administration for endo. and verify contraceptive efficacy) ■ Continue to improve Gross to Net *Source Symphony Health, an ICON plc Company, IDVⓇ **Source IQVIA NSP sales as of end of Feb. 2023 and TRX as of end of Mar. 2023. Sales for MYFEMBREE®, ORIAHNN, ORILISSA, Lupron Depot 3.75MG/11.25MG, and Lupaneta Pack for the 12 months ended Feb. 2023 were $481M (130yen/$), which reflects a 19% growth vs 12 months ended Feb. 2022#10Financial Results for Q4 FY2022 ■Marketing Status of GEMTESAⓇ Approx. 190,000 TRx in Q4 FY2022, which is greater than our FY2022 forecast (20% growth vs. Q3 FY2022) +20% ■The market for overactive bladder (OAB) of GEMTESAⓇ is over 400 billion yen/year (gross conversion), and recently expanded by 8% annually* Established broad health plan coverage (Percentage of coverage obtained as of April 2023: total of Medicare Part D lives was approx. 80%, total of commercial lives was >70%) 193,661 161,156 133,949 101,140 65,858 48,299 26,715 6,800 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 FY2021 FY2021 FY2021 FY2021 FY2022 FY2022 FY2022 FY2022 ■Phase 3 study results for OAB associated with benign prostatic hyperplasia will be obtained in 1H FY2023, and sNDA will be submitted in 2H FY2023 Number of prescriptions per quarter with GEMTESA®* *Source IQVIA *NSP sales as of end of Feb. 2023 and TRx as of end of Mar. 2023. Sales for GEMTESAⓇ, MYRBETRIQ, TOVIAZ, and Generics for the 12 months ended Feb. 2023 were $3.1B (130yen/$), which reflects a 8% growth vs 12 months ended Feb. 2022#11Financial Forecasts for FY2023 Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 10#12Financial Forecasts for FY2023 Financial Forecasts for FY2023 (Core Basis) Billions of yen Revenue FY2022 Results 555.5 FY2023 Forecasts Value Change FX % Cost of sales Gross profit SG&A expenses 176.7 378.8 305.6 R&D expenses 106.1 84.0 Other operating income and expenses 49.2 12.0 (Core basis) Core operating profit 16.4 (62.0) 362.0 (193.5) (9.5) (34.8) 132.0 (44.7) (3.0) (25.3) 230.0 (148.8) (6.5) (39.3) 220.0 (85.6) (6.7) (28.0) (22.1) (2.3) (20.8) (37.2) (0.2) (75.6) (78.4) 2.3 Expect both revenue and profit down for FY2023 Revenue: Japan (¥21.1B), North America (¥119.7B), China (¥6.4B), Other Business (¥43.3B) ⚫ Japan will be affected by termination of sales collaboration of Trulicity, NHI price revision • North America will be affected by loss of exclusivity of LATUDAⓇ, while ORGOVYX®, MYFEMBREE®, GEMTESAⓇ will grow ⚫ China will decrease due to the growing impact of Volume- Based Procurement application for MEROPENⓇ ⚫ Other Business will decrease due to the transfer of subsidiaries Non-recurring item (93.3) (16.0) 77.3 (negative number indicates loss) SG&A and R&D expenses: Operating profit (77.0) (78.0) (1.0) 1.3 •SG&A and R&D will decrease mainly due to the Income tax expenses 48.8 (1.0) (49.8) (96.7) (80.0) 16.7 (74.5) (80.0) (5.5) the parent Net profit Net profit attributable to owners of ROE (%) ROIC (%) Sumitomo Pharma (14.7%) (21.9%) (3.9%) (8.5%) FX rates: FY2022 Results 1US$ = ¥135.51, 1RMB = \19.75 FY2023 Forecasts: 1US$ = ¥130.00, 1RMB = \19.50 Combination of Group Companies in the U.S. Other operating income and expenses (Core basis): ⚫ Sale of assets will decrease Non-recurring item: • Temporary expenses associated with the Combination of Group Companies in the U.S. are expected © Sumitomo Pharma Co., Ltd. All Rights Reserved. 11 7.4#13Financial Forecasts for FY2023 Segment Information (Core Basis) Billions of yen Japan segment: Profit will increase due to the effects of reduced SG&A expenses, while revenue will decrease North America segment: Gross profit will decrease significantly due to the decrease in revenue. Profit is expected to decline significantly, while cost reduction through streamlining is expected China segment: Profit will decrease because revenue decrease largely Other Regions segment: Decreased revenue and profit due to one-time payments based on out-licensing agreements in FY2021 Other Business: Revenue will decrease due to the transfer of two subsidiaries and profit will decrease due to a decrease in transfer gains Pharmaceuticals Business North Other Japan China Subtotal Other Business Total America Regions Revenue (Sales to customers) 105.0 208.8 33.0 13.7 360.5 1.5 362.0 Cost of sales 48.1 68.8 7.4 6.8 131.1 0.9 132.0 Gross profit 56.9 140.0 25.6 6.9 229.4 0.6 230.0 SG&A expenses 46.1 160.3 10.6 1.8 218.8 1.2 220.0 Core segment profit 10.8 (20.3) 15.0 5.1 10.6 (0.6) 10.0 R&D expenses 82.0 2.0 84.0 Core operating profit (65.4) 3.4 (62.0) Revenue (Sales to customers) 126.1 328.5 39.4 16.8 510.7 44.8 555.5 Cost of sales 65.3 62.4 8.4 5.1 141.3 35.4 176.7 Gross profit 60.9 266.0 31.0 11.6 369.5 9.3 378.8 SG&A expenses 51.8 233.8 11.4 1.6 298.7 7.0 305.6 Core segment profit 9.1 32.2 19.5 10.0 70.8 2.4 73.2 R&D expenses 103.2 2.8 106.1 Core operating profit (8.0) 24.3 16.4 Revenue (Sales to customers) (21.1) (119.7) (6.4) (3.1) (150.2) (43.3) (193.5) SG&A expenses (5.7) (73.6) (0.8) 0.2 (79.9) (5.8) (85.6) Core segment profit 1.7 (52.5) (4.5) (4.9) (60.2) (3.0) (63.2) R&D expenses Core operating profit Sumitomo Pharma (21.2) (0.8) (22.1) (57.4) (21.0) (78.4) FY2023 Forecasts FY2022 Results Change © Sumitomo Pharma Co., Ltd. All Rights Reserved. 12#14Financial Forecasts for FY2023 Revenue of Major Products in Japan FY2022 FY2023 Results Forecasts Value % Change Billions of yen Revenue will decrease ¥21.1B on Japan segment total EquaⓇ/EquMetⓇ 33.6 32.4 (1.2) (3.4) TRERIEF 16.7 15.0 (1.7) (10.0) LATUDAⓇ 9.6 12.5 2.9 30.5 Sales of LATUDAⓇ and METGLUCO® 7.7 7.5 (0.2) (2.6) TWYMEEGⓇ are expected to increase TWYMEEG 2.2 4.2 2.0 89.3 LONASEN Tape 2.9 3.3 0.4 12.2 AG products 9.2 8.6 (0.6) (6.1) TrulicityⓇ* 24.8 - (24.8) Others 19.5 21.5 2.0 Total 126.1 105.0 (21.1) 10.3 (16.7) Note: Sales of each product are shown by invoice price (* Trulicity is shown by NHI price) Sales collaboration of TrulicityⓇ was terminated in December 2022 NHI price revision impact in FY2023 (approx.\5.0B) Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 13#15Financial Forecasts for FY2023 Revenue of Major Products in North America & China Change FY2022 Results FY2023 Forecasts Change FY2022 Results FY2023 Forecasts Value FX impact % North America Million $ Billions of yen ORGOVYXⓇ 182 396 214 24.7 51.5 26.8 (2.2) MYFEMBREEⓇ 33 192 159 4.5 24.9 20.4 (1.1) 108.5 454.1 GEMTESAⓇ 182 362 180 24.7 47.0 22.3 (2.0) 90.5 APTIOMⓇ 249 273 24 33.7 35.5 1.8 (1.5) 5.3 RETHYMICⓇ 33 54 21 4.4 7.0 2.6 (0.3) 57.7 LATUDAⓇ 1,465 161 (1,304) 198.5 20.9 (177.6) (0.9) (89.5) Others 280 167 (113) 38.0 22.0 (16.0) (0.9) (42.0) Total 2,424 1,605 (819) 328.5 208.8 (119.7) (8.8) (36.4) China Million RMB Billions of yen MEROPENⓇ 1,445 958 (487) 28.5 18.7 (9.8) (0.2) (34.5) Others Total 550 737 187 10.9 14.3 3.4 1,995 1,695 (300) 39.4 33.0 (6.4) (0.4) (0.2) 31.6 (16.2) * Lump-sum revenue included in "Others" FY2022 Deferred revenue from the collaboration with Pfizer of $138M Revenue from the license agreement for ORGOVYX® of $50M FY2023 Deferred revenue from the collaboration with Pfizer of $117M North America segment Due to loss of exclusivity of LATUDAⓇ in February 2023, revenue will decrease significantly in FY2023 ORGOVYXⓇ and MYFEMBREEⓇ will accelerate the efficiency of sales activities with the acquisition of Myovant as a wholly owned subsidiary ■GEMTESAⓇ is expected continued steady growth ■ KYNMOBIⓇ and LONHALAⓇ MAGNAIRⓇ have been decided to discontinue sales China segment Revenue of MEROPENⓇ will be expected to decrease due to the growing impact of Volume-Based Procurement application FX rates: FY2022 Results : 1US$ ¥135.51, 1RMB = \19.75 FY2023 Forecasts: 1US$ = ¥130.00, 1RMB = \19.50 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 14#16Research and Development Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 15#17Research and Development Development Pipeline (as of May 15, 2023) |: Psychiatry & Neurology Area Japan U.S. : Oncology : Others DSP-9632P Phase 1 (Levodopa-induced dyskinesia in Parkinson's disease) DSP-0187 (Narcolepsy) DSP-0378 (Dravet syndrome, Lennox- Gastaut syndrome) DSP-3905 (Neuropathic pain) SEP-378614 (To be determined) SEP-380135 (To be determined) DSP-0038 (Alzheimer's disease psychosis) DSP-3456 (Treatment resistant depression) DSP-2342 (To be determined) TP-3654 (Myelofibrosis) DSP-5336 (Acute leukemia) DSP-0390 (Glioblastoma) TP-3654 (Myelofibrosis) DSP-5336 (Acute leukemia) DSP-0390 (Glioblastoma) TP-1287 (Solid tumors) TP-1454 (Solid tumors) KSP-1007 (Complicated urinary tract infections, Complicated intra-abdominal infections) SP-101 (cystic fibrosis) Phase 2 EPI-589 (ALS/Investigator-initiated study) Allo iPS cell-derived products (Parkinson's disease/ Investigator-initiated study) EPI-589 (Parkinson's disease/ALS) ulotaront (SEP-363856) (Parkinson's disease psychosis) rodatristat ethyl (Pulmonary arterial hypertension) URO-902 (Overactive bladder) Revisions since the announcement of January 2023 are shown in red Phase 3 ulotaront (SEP-363856) (Schizophrenia) ulotaront (SEP-363856) (Generalized anxiety disorder)* SEP-4199 (Bipolar I depression) ulotaront (SEP-363856) (Schizophrenia) ulotaront (SEP-363856) (Adjunctive major depressive disorder)* ulotaront (SEP-363856) (Generalized anxiety disorder)* SEP-4199 (Bipolar I depression) GEMTESAⓇ (vibegron) (New indication: OAB in men with BPH) NDA submitted China ulotaront (SEP-363856) (Schizophrenia) vibegron (Overactive bladder) *Phase 2/3 study lefamulin (Bacterial community-acquired pneumonia) © Sumitomo Pharma Co., Ltd. All Rights Reserved. 16#18Research and Development Clinical Development Status (Major Changes since January 31, 2023) DSP-2342 U.S.: Started Phase 1 study (Proposed indication: To be determined) SEP-378608 U.S.: Discontinued development for bipolar disorder (Phase 1 study) Vibegron China: Started Phase 3 study (Overactive bladder) SP-101 U.S.: Started Phase 1 study (Proposed indication: cystic fibrosis) URO-902 U.S.: Discontinued in-house development for overactive bladder (OAB) (Phase 2 study), out-licensing under consideration Decided to discontinue development of DSP-0509, which was under consideration for development strategy Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 17#19Research and Development Ulotaront: Development Progress and Future Plans (Co-Development with Otsuka Pharmaceutical) Schizophrenia: Clinical program lead: Sunovion/Sumitomo Pharma Phase 3 DIAMOND clinical study program on-track Results from the efficacy studies (DIAMOND 1 and DIAMOND 2 studies) anticipated in H1 FY2023 NDA submission to the U.S. FDA is anticipated in FY2023 Adjunctive treatment of major depressive disorder (aMDD): Clinical program lead: Otsuka Pharmaceutical First patient randomized in November 2022 Phase 2/3 study is ongoing Generalized Anxiety Disorder (GAD): Clinical program lead: Sunovion/Sumitomo Pharma First patient randomized in April 2023 Phase 2/3 study is ongoing Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 18#20Research and Development Main Events / Targets for FY2023 (as of May 15, 2023) Psychiatry & Neurology Oncology Others Frontier ☐ ulotaront □ Obtain results from two Phase 3 studies for schizophrenia (□ DIAMOND 1 □ DIAMOND 2) (SEP-363856) ☐ Submit NDA for schizophrenia in the U.S. ☐ Advance Phase 2/3 study in Japan and China for schizophrenia □ Advance Phase 2/3 studies for two additional indications (aMDD, GAD) SEP-4199: Advance Phase 3 studies for Bipolar I depression Allogeneic iPS cell-derived products (Retinal pigment epithelium tear): Start clinical study in Japan ☐ Allogeneic iPS cell-derived products (Parkinson's disease): Start clinical study in the U.S. ☐ Complete manufacturing plant in the U.S. (for RETHYMICⓇ and allogeneic iPS cell-derived products) Advance early Phase studies ☐ relugolix: Obtain approval for endometriosis in Europe vibegron: Obtain results from Phase 3 study and submit sNDA for overactive bladder (OAB) with benign prostatic hyperplasia in the U.S. rodatristat ethyl: Obtain results from Phase 2 study for pulmonary arterial hypertension (PAH) ☐ universal influenza vaccine, malaria vaccines: Promote joint research and development projects Launch product: (Japan) Automated blood collection/stabilization device ☐ Promoting the current themes and generating evidence data for maximizing the value of the launched products Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 19#21Appendix <Contents> FY2022 Financial Results (Full Basis) Main Events/Targets for FY2022 Product Launch Target P.21 P.22 FY2022 Financial Position P.23 R&D P.24 R&D P.25 R&D P.26 R&D P.27 R&D P.28 R&D Sumitomo Pharma Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline Product Launch Target (Frontier Business) New Chemical Entity: DSP-2342 New Chemical Entity: SP-101 © Sumitomo Pharma Co., Ltd. All Rights Reserved. 20#22Appendix (Financial Results for FY2022) Financial Results for FY2022 (Full Basis) Billions of yen FY2021 FY2022 Change Results Results Value % Revenue Cost of sales 560.0 555.5 (4.5) (0.8) 157.1 178.9 21.8 13.9 Gross profit 402.9 376.6 (26.3) (6.5) SG&A expenses 249.1 373.3 124.2 49.9 R&D expenses 94.9 131.9 37.0 38.9 Other operating income and expenses 1.3 51.6 50.3 Operating profit 60.2 (77.0) (137.2) Finance income and costs 22.7 29.1 6.3 Profit before taxes 83.0 (47.9) (130.9) Income tax expenses 42.4 48.8 6.4 Net profit 40.6 (96.7) (137.3) Net profit attributable to owners of the parent 56.4 (74.5) (130.9) Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 21#23Appendix (Financial Results for FY2022) Financial Position B/S Billions of yen As of March 2022 As of March Change 2023 Assets 1,308.0 1,134.7 (173.3) Impairment losses Goodwill Intangible assets 593.8 538.7 Other financial assets (Non-current) 115.8 134.0 (55.1) 18.2 Trade and other receivables 151.4 95.9 (55.5) Cash and deposit / Short-term loan receivable 230.2 153.5 (76.7) Liabilities 634.4 728.0 93.5 Increase due to changes in valuation of securities Decrease due to loss of exclusivity of LATUDAⓇ Payment for making Myovant a wholly owned subsidiary Bonds and borrowings 269.0 334.7 65.7 Fair value of contingent consideration 4.4 1.5 (Other financial liaiabilities) Deferred tax liabilities Income taxes payable Equity Attributable to owners of the parent (Ratio of equity attributable to owners of the parent) to total assets (2.9) Financing to make Myovant a wholly owned subsidiary 26.6 36.5 10.0 7.6 24.1 16.5 673.6 406.8 (266.8) 607.9 406.7 (201.1) Impact of making Myovant a wholly owned subsidiary 46.5% 35.8% C/F FY2021 FY2022 Change Operating CF 31.2 11.9 (19.3) Investment CF (18.3) 52.4 Financial CF (21.4) (146.8) 70.7 (125.4) Cash and cash equivalents 203.0 143.5 (59.5) Proceeds from sales of the share of Sumitomo Pharma Food & Chemical Co., Ltd. and intangible assets etc. Decrease in payment for making Myovant a wholly owned subsidiary (Operating funds) 234.9 158.0 (76.9) © Sumitomo Pharma Co., Ltd. All Rights Reserved. 22#24Appendix (Research and Development) Main Events / Targets for FY2022 (as of May 15, 2023) Psychiatry & Neurology ✓ ulotaront (SEP-363856) ✓ ✓ Completed action/target Revisions since the announcement of January 2023 are shown in red Adjunctive major depressive disorder ✓ Generalized anxiety disorder Start clinical studies for two new indications Advance Phase 3 study in the U.S. and Phase 2/3 study in Japan and China for schizophrenia SEP-4199: Advance Phase 3 studies for Bipolar I depression Oncology ☑ relugolix (Europe) Obtain approval for prostate cancer Advance early Phase studies Regenerative ☐ Allogeneic iPS cell-derived products (AMD: age-related macular degeneration): Start clinical study in Japan Allogeneic iPS cell-derived products (Parkinson's disease): Start clinical study in the U.S. medicine/ Cell therapy Infectious Diseases Others Frontier ✓ Start construction of manufacturing plant in the U.S (for RETHYMICⓇ and allogeneic iPS cell-derived products) KSP-1007 (Antimicrobial resistance) : Complete Phase 1 study in the U.S. universal influenza vaccine, malaria vaccines: Promote joint research and development projects relugolix : (U.S.) (Europe) Obtain approval for endometriosis Submit MAA for endometriosis ✓ Launch products: ✓ (Japan) MELTz Neurorehabilitation device for hand/fingers (U.S.) VR contents for mental health (brand name: First Resort, general wellness product) Promoting the current themes and generating evidence data for maximizing the value of the launched products: Digital device for relieving BPSD, etc. Sumitomo Pharma © Sumitomo Pharma Co., Ltd. All Rights Reserved. 23#25Appendix (Research and Development) Product Launch Target (as of May 15, 2023) Psychiatry & Neurology Oncology Others FY2025 FY2026 ulotaront (TAAR1 agonist) Allogeneic iPS cell- derived dopaminergic neural progenitor cells (DSP-1083) Allogeneic iPS cell-derived retinal pigment epithelial cells (HLCR011) DSP-5336 (menin and MLL inhibitor) TP-3654 (PIM kinases inhibitor) GEMTESAⓇ (B3-adrenergic receptor agonist) rodatristat ethyl (tryptophan hydroxylase inhibitor) lefamulin (antimicrobial agent of pleuromutilin class) FY2023 FY2024 Schizophrenia Parkinson's disease *1 Retinal pigment epithelium tear*1 Bacterial community- acquired pneumonia *1 Launch schedule is based on our goal pending agreement with partners *2 Premise to utilize an application of accelerated approval program (Plan to consult with the FDA) Overactive bladder with BPH Acute myeloid leukemia *2 FY2027 Schizophrenia Expand indications Development in the U.S Expand indications Acute myeloid leukemia Expand indications Myelofibrosis Expand sales countries Overactive bladder Pulmonary arterial hypertension © Sumitomo Pharma Co., Ltd. All Rights Reserved. 24#26Appendix (Research and Development) Regenerative Medicine/Cell Therapy Launched Product and Development Pipeline (as of May 15, 2023) Proposed indication, etc. Partnering Pediatric congenital Region (planned) Revisions since the announcement of January 2023 are shown in red status Cell type Duke University Global Cultured thymus tissue Launched in March 2022 (U.S.) athymia (RETHYMIC®) RPE tear AMD (age-related macular degeneration) Healios Global Allo iPS cell-derived retinal pigment RIKEN Parkinson's disease Kyoto (Designated as a University Global "SAKIGAKE") CIRA Allo iPS cell-derived Retinitis pigmentosa RIKEN Global photoreceptor (3D) Spinal cord injury Keio University Osaka National Hospital Global Allo iPS cell-derived neural progenitor cells Kidney failure Jikei University Bios Japan, North America epithelium cells Allo iPS cell-derived dopamine neural progenitor cells Preparing to start clinical study (Japan) In progress: investigator-initiated study (Phase 1/2 study) (Japan) Preparing to start clinical study (U.S.) In progress: clinical research In progress: clinical research (Sub-Acute Phase) In progress: pre-clinical study (Chronic Phase) Aim to start clinical study in FY2023 Aim to launch in FY2024 (Japan)* Auto/ Allo iPS cell- based induced nephron progenitor cells (organ) * Launch schedule is based on our goal pending agreement with partners In progress: pre-clinical study © Sumitomo Pharma Co., Ltd. All Rights Reserved. 25#27Appendix (Research and Development) ■Frontier Business Product Launch Target (as of May 15, 2023) : Non-medical device : Medical device VR contents (BehaVR, Inc.) MELTZⓇ (MELTIN) FY2023 FY2024 FY2025 FY2026 Social Anxiety Disorder "MELTZⓇ Portable" (finger exercise training system) Wearable EEG meter (NeuroSky Co., Ltd.) Violet Light (Tsubota Laboratory Incorporated) Automated blood collection/ stabilization device (Drawbridge Health, Inc.) Self-management solutions for metabolic diseases* Depression Depression / Dementia * At the start of the business, we plan to provide management solutions for metabolic disease management Sumitomo Pharma FY2027 VR contents in other disease area Neurorehabilitation device for hand/fingers Depression Depression / Dementia © Sumitomo Pharma Co., Ltd. All Rights Reserved. 26#28Appendix (Research and Development) New Chemical Entity: DSP-2342 ✓ Target indication: To be determined ✓ Origin: In-house (Joint research with Exscientia) ✓ Mechanism of action: Serotonin 5-HT 2A and 5-HT7 receptor antagonist ✓ Stage: Phase 1 in the U.S. ✓ Expected profile: ➤ DSP-2342 is a novel compound discovered at Sumitomo Pharma using Exscientia's Al technologies, and is expected to demonstrate a broad effect on psychiatric symptoms which include psychosis, anxiety and depression, based on the additive effect of 5-HT 2A and 5-HT7 receptor antagonist ➤ DSP-2342 has high selectivity for 5-HT 2A and 5-HT7 receptors, which can be expected to show a high safety and tolerability Sumitomo Pharma 5-HT2A DSP-2342 inhibition 5-HT7 NAC FC PVT VTA Amy Raphe Hipp Antidepressant Anxiolytic Anti-psychosis Procognitive effect Sleep improvement ©Sumitomo Pharma Co.,Ltd. All Rights Reserved. 27#29Appendix (Research and Development) New Chemical Entity: SP-101 ✓ Target indication: Cystic Fibrosis ✓ Origin: In-house (Spirovant Sciences, Inc.) ✓ Mechanism of action: CFTR gene transfer to lung ✓ Stage: Phase 1/2 in the U.S. ✓ Expected profile: SP-101 is a novel adeno-associated viral (AAV) vector engineered to efficiently transduce human airway epithelia from the apical (lumen) surface. It is designed to deliver a shortened but fully functional cystic fibrosis transmembrane conductance regulator (CFTR) gene to the airways of people living with Cystic Fibrosis (CF) Based on preclinical data, the addition of doxorubicin substantially improves SP-101 transduction and subsequent expression of the CFTR gene. SP-101 followed by doxorubicin administered via a nebulizer is being developed as a combination product for the treatment of CF. SP-101 is expected to restore CFTR function and halting disease progression in the lungs of people living with CF Sumitomo Pharma ©Sumitomo Pharma Co.,Ltd. All Rights Reserved. 28#30Sumitomo Pharma Innovation today, healthier tomorrows

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Q4 & FY22 - Investor Presentation image

Q4 & FY22 - Investor Presentation

Financial Services

FY23 Results - Investor Presentation image

FY23 Results - Investor Presentation

Financial Services

Ferocious - Plant Growth Optimizer image

Ferocious - Plant Growth Optimizer

Agriculture

Market Outlook and Operational Insights image

Market Outlook and Operational Insights

Metals and Mining

2023 Investor Presentation image

2023 Investor Presentation

Financial

Leveraging EdTech Across 3 Verticals image

Leveraging EdTech Across 3 Verticals

Technology

Axis 2.0 Digital Banking image

Axis 2.0 Digital Banking

Sustainability & Digital Solutions

Capital One’s acquisition of Discover image

Capital One’s acquisition of Discover

Mergers and Acquisitions