Slide 1: FY9/2021 Investor Meeting Materials
FY9/2021 Investor Meeting Materials November 18, 2021 Fuji Pharma Co., Ltd. TSE1 4554
Slide 2: Agenda
Agenda Chapter 1 FY9/21 Consolidated Financial Results Chapter 2 FY9/22 Consolidated Forecast Chapter 3 Mid-Term Business Plan Progress Summary Chapter 4 Product Portfolio Developments ©2021 Fuji Pharma Co., Ltd. All rights reserved. 2
Slide 3: FY9/21 Consolidated Financial Results
©2021 Fuji Pharma Co., Ltd. All rights reserved. 1 FY9/21 Chapter Consolidated Financial Results 3
Slide 4: FY9/21 Financial Result Highlights
FY9/21 Financial Result Highlights ⚫ Net sales and profit increased year on year on consolidated and non-consolidated basis Net sales：Growth in women’s healthcare products made up for the decline in diagnostic drugs Expenses：YoY ▲2.8% due to decrease in sales commission and R&D expenses OLIC:
Slide 5: FY9/21 Consolidated Financial Results
FY9/21 Consolidated Financial Results ⚫ Net Sales：Iincreased by JPY 197 million（YoY+0.6％）‐ the increased sales of women‘s healthcare products covered the impact of NHI price revisions and COVID-19 ⚫ Operating Profit：Increased by JPY 210 million（YoY+6.7%）- Gross margin decreased due to the impact of
Slide 6: FY9/21 Consolidated Financial Results (YoY)
FY9/21 Consolidated Financial Results (YoY) Net Sales（Unit:¥million） Operating Profit（Unit:¥million） ▲260 ▲299 ▲30 ▲30 ▲244 ▲141 ▲508 ▲140 ▲401 +36 +78 +23 +144 +1,395 Filgrastim ▲230 +170 +614 *1 IOPAMIDOL ▲177 IOHEXOL ▲84 33,990 3,349 33,793 Oral contraceptives +452 3,139 Non-consolidated OLIC DIE
Slide 7: FY9/21 Consolidated Financial Results (v. Forecast)
FY9/21 Consolidated Financial Results (v. Forecast) Net Sales（Unit:¥million） Operating Profit（Unit:¥million） IOPAMIDOL ▲220 IOHEXOL ▲692 ▲913 In-vitro Diagnostic ▲378 ▲859 ▲40 +686 ▲231 ±０ +29 ＋94 +161 ▲156 +120 ▲317 +201 +251 +754 Oral contraceptives ▲164 34,702 DIENOGEST +459 3,349 Infertility tre
Slide 8: Sales by Therapeutic Category
Sales by Therapeutic Category YoY Change (\million) FY9/17 FY9/18 FY9/19 FY9/20 FY9/21 Amount Ratio Hormone drugs 10,275 10,981 10,741 10,363 11,758 1,395 13.5% Diagnostic drugs 13,473 14,323 10,827 8,570 8,310 ▲ 260 -3.0% Metabolic drugs 2,828 2,882 3,074 3,216 2,917 ▲ 299 -9.3% Nervous system & se
Slide 9: Sales of Major Products
Sales of Major Products Product Name Therapeutic YoY Change FY9/21 FY9/17 FY9/18 FY9/19 FY9/20 FY9/21 (\million) Category Amount Ratio Budget ★IOPAMIDOL injection Diagnostic drugs 6,879 6,769 7,192 6,401 6,224 ▲ 177 -2.8% 6,444 ★IOHEXOL injection Diagnostic drugs 2,162 2,010 2,287 2,172 2,088 ▲ 84 -
Slide 10: Sales by Medical Field and Dosage Form Category
Sales by Medical Field and Dosage Form Category Sales Breakdown by Medical Field CMO Business Medical Field Category YoY (OLIC) FY9/17 FY9/18 FY9/19 FY9/20 FY9/21 Others (\million) Amount Ratio 6.3% 8.8% Acute Medical Care 20,264 21,895 19,340 16,926 16,745 ▲ 181 -1.1% Acute FY9/21 Women's Healthcar
Slide 11: Sales of Acute Medical Care and Women's Healthcare
Sales of Acute Medical Care and Women's Healthcare Acute Medical Care Net Sales Percentage Others 24.6% Acute Medical Care YoY FY9/17 FY9/18 FY9/19 FY9/20 FY9/21 FY9/21 (\Million) Amount Ratio Acute Medical Contrast Media 13,193 14,062 11,852 9,423 9,151 ▲ 272 -2.9% Anti-cancer Care Sales Contrast B
Slide 12: FY9/21 Summary of Consolidated Balance Sheet
FY9/21 Summary of Consolidated Balance Sheet FY9/20 FY9/21 YoY Change (\million) Year End Year End Amount Ratio Decrease due to Toyama plant CAPEX and share buy Assets back Current Assets 34,975 34,834 ▲ 141 -0.4% Cash and Deposits 12,041 10,199 ▲ 1,842 -15.3% Notes and Accounts Receivable - Trade 1
Slide 13: FY9/21 Summary of Consolidated Statements of Cash Flows
FY9/21 Summary of Consolidated Statements of Cash Flows FY9/20 FY9/21 YoY Change (\million) Year End Year End Amount Ratio Cash Flows from Operating Activities 5,770 5,993 223 3.9% (Major Breakdown) Profit before Income Taxes 2,918 3,371 453 15.5% Depreciation 1,774 1,828 54 3.0% Impairment Losses ‐
Slide 14: FY9/22 Consolidated Forecast
©2021 Fuji Pharma Co., Ltd. All rights reserved. 2 FY9/22 Chapter Forecast Consolidated 14
Slide 15: FY9/22 Consolidated Forecast Highlights
FY9/22 Consolidated Forecast Highlights ⚫ Net sales and profits increase YoY 2 years in a row Net sales：Increase of new products, new in-licensed products, existing women's healthcare products and OLIC Operating profit：Increase in sales contributes to profit increase despite increased R&D and ot
Slide 16: FY9/22 Consolidated Forecast
FY9/22 Consolidated Forecast ⚫ Net sales：Increased by JPY 3,321 million（YoY+10.2％）‐ New products, new in-licensed products, existing women‘s healthcare products and OLIC offset impact of NHI price revisions and the decline in diagnostic drugs ⚫ Operating profit：Increased by JPY 141 million (YoY+4.2%
Slide 17: Summary of FY9/22 Consolidated Forecast (YoY)
17 3,490 associated with the FY9/22 Forecast progress of S&M Upfront costs Consolidation adjustment +31 expense decrease ▲167 SG&A expenses increase OLIC +46 +213 Operating Profit（Unit:¥million） Gross profit increase ▲443 Other SG&A expense increase Non-consolidated Expenses increase due to ▲273 COV
Slide 18: Sales Forecast by Therapeutic Category and Medical Field
Sales Forecast by Therapeutic Category and Medical Field FY9/21 FY9/22 YoY Change (\million) Actual Forecast Amount Ratio Hormone drugs 11,758 14,901 3,143 26.7% Diagnostic drugs 8,310 7,533 ▲ 777 -9.4% Metabolic drugs 2,917 2,513 ▲ 404 -13.8% Nervous system & sensory organs drugs 1,170 1,130 ▲ 40 -
Slide 19: FY9/22 Shareholder Return Policy
FY9/22 Shareholder Return Policy ⚫ Our dividend policy is to achieve a dividend payout ratio of 30% with stable dividends. ⚫ Therefore, we plan to pay 32 yen annual dividend by applying dividend payout ratio of 30% to FY9/22 forecast profit.（Interim 15 yen, Year-end 17 yen） Dividend per share（JPY） /
Slide 20: Mid-Term Business Plan Progress Summary
©2021 Fuji Pharma Co., Ltd. All rights reserved. 3 Chapter Progress Mid-Term Summary Business Plan 20
Slide 21: Mid-term Business Plan (Announced in May 2020)
Mid-term Business Plan (Announced in May 2020) Theme Fujiらしくをあたらしく Target in 9/2029 “Evolving Fuji” Sales Business Plan based Roadmap to achieve Goal Positioning on Vision for 2030 Vision for 2030 100 JPY bil+ ⚫ No.1 in Women’s Healthcare (WH) Growth ⚫ Evolving into sustainable Contrast Media busine
Slide 22: Financial Target (9/2024) and 9 Strategies
Financial Target (9/2024) Sales (JPY bil) 60 CM OS Others +2.4 WH BS +6.4 ▲2.1 50.0 50 +9.8 ▲0.3 40 CM 33.8 OS 30 BS 20 WH 10 0 9/2020 MTP 9/2024 9 Strategies ①WH ②Injection ③Hormone ④NGT ⑤BS ⑥Asia ⑦N. America ⑧HR ⑨Sustainability ©2021 Fuji Pharma Co., Ltd. All rights reserved. 22
Slide 23: Summary of Progress in second half FY9/21
Summary of Progress in second half FY 9/21 Progressing toward “Net sales JPY 50 bil. for FY9/24” ⚫ Toward No.1 in WH ⚫ Strengthen OS business • Growing 6 key products OLIC • Recovering Asian CMO WH • F-menoⓇ Capsules business approved • Established S&M • Started e-Promotion function in OLIC ⚫ Evolvi
Slide 24: Women's Healthcare
Women’s Healthcare FY9/21 Achievements FY9/22 Actions ⚫ Complete new tablet building ⚫ Increased as planned (Start production in Nov. 2022) (126％ YoY, 105% vs. forecast) ⚫ Promote oral contraceptive Increase Revenue ⚫ Steady progress in construction enlightenment activities of 6 Key Products of new
Slide 25: Women's Healthcare ~6 Key Products
Women’s Healthcare ～6 Key Products Sales Trend of 6 Key Products （JPY bil) 10 10 10 8 6.1 6 5.3 4.6 4.8 4 2 0 FY9/20 FY9/21 FY9/24 MTP Actual/Forecast ©2021 Fuji Pharma Co., Ltd. All rights reserved. 25
Slide 26: Biosimilar
Biosimilar FY9/21 Achievements FY9/22 Actions ⚫ Steady progress toward ⚫ Apply for approval of 1 Alvotech 5 applying for approval of 1 Product product Alvotech product in FY9/22 Development ⚫ Prepare application of other 5 ⚫ Implemented Alvotech Product- Alvotech products development monitoring ⚫ De
Slide 27: OLIC・CM
OLIC・CM FY9/21 Achievements FY9/22 Actions ⚫ Mitigated COVID-19 impact by actively adding CMO contracts ⚫ Recover profits to levels prior to （104% vs. forecast） COVID-19 ⚫ Steady progress to establish ⚫ FSN-013：Seek approval of 4 S&M function in OLIC, including import license in Thailand application
Slide 28: Capex on Toyama Plant
Capex on Toyama Plant 2019 2020 2021 2022 2023 Ground PV (Nov.) New tablet building WH Breaking ⚫ Hormone tablet manufacturing / expand (Dec.) testing capacity ⚫ High containment technology for hormone tablet manufacturing ⚫ Response to PIC/S GMP inspection standards Ground PV (Nov.) Adding ampoule/
Slide 29: Sustainability
Sustainability ◼ Sustainability Committee chaired by the president and Sustainability Section play a central role, positioning sustainability as one of 9 strategies of MTP, and pursue each of 7 core themes of ISO26000, to promote sustainability activities. ◼ Major Activities in FY9/21 Environment So
Slide 30: Quality Control Initiatives
Quality Control Initiatives ⚫ Launched web page on quality initiatives in July 2021. https://www.fujipharma.jp/company/quality/ Quality policy Disclosure of the inspection plan and progress 1.Thoroughly comply with laws and regulations of the manufacturing and marketing approval 2.Guarantees hig
Slide 31: Product Portfolio Developments
©2021 Fuji Pharma Co., Ltd. All rights reserved. 4 Chapter Developments Product Portfolio 31
Slide 32: WH ~Our Strengths
WH ～Our Strengths Age8~9 Around Age 19 Around Age 45 Around Age 55 Puberty Reproductive period Menopause Senium Dysmenorrhea LUNABELL® tablets LD/ULD Under Treatment 3 development FSN-013 Oral Favoir® tablets Contraceptives Labellefille® tablets Emergency LEVONORGESTREL tablets Contraceptives Endome
Slide 33: WH ~F-meno Capsules
1 WH ～F-menoⓇ Capsules Brand name ： F-meno® Capsules 100mg（approved in Sep. 2021） Indications ： Prevention of endometrial hyperplasia upon administration of estrogen drug for menopausal disorders and ovarian deficiency symptoms History ⚫ In Japan, there has been no progestogen drug indicated for hor
Slide 34: WH ~PROPESS 10mg vaginal delivery system
2 WH ～PROPESS® 10mg vaginal delivery system Strategic collaboration with Ferring Pharmaceuticals about PROPESS® in Japan From Dec. 1, 2021, Fuji Pharma will be responsible for the sales and distribution →Expanding product portfolio in women's healthcare in perinatal area Outline B ra n d N a me : PR
Slide 35: WH ~FSN-013 (Japan)
3 WH ～FSN-013（Japan） Positioning of FSN-013： New stage for Fuji as a market leader in Dysmenorrhea LUNABELL® tablets FSN-013 • Launched in July 2008 • Approved as the first in Japan product • Next generation drug for with dysmenorrhea indication dysmenorrhea • Formed and expanded the market by • It
Slide 36: WH ~FSN-013: Product Summary
3 WH ～FSN-013：Product Summary Started Phase III (Aug. 2021) Overview ⚫ Next-generation novel dysmenorrhea drugs ⚫ Combination with progesterone (drospirenone) ⚫ Estetrol is a novel unique estrogen ⚫ It is expected and developed to reduce the commonly reported side effects of a combination containing
Slide 37: WH ~FSN-013: Outline of Japan Phase III (FSN-013-03)
3 WH ～FSN-013：Outline of Japan Phase III（Study No. FSN-013-03） A total of 28 days of administration of FSN-013(Estetrol [E4] 15 mg/drospirenone [DRSP] 3 mg combination tablet) for 24 days followed by placebo tablets for 4 days in Japanese patients Test Purpose with dysmenorrhea are taken as one cycl
Slide 38: WH ~FSN-013: Outline of Japan Phase III (FSN-013-04)
3 WH ～FSN-013：Outline of Japan Phase III（Study No. FSN-013-04） A total of 28 days of administration of FSN-013(Estetrol [E4] 15 mg/drospirenone [DRSP] 3 mg combination tablet) for 24 days followed by placebo tablets for 4 days in Japanese patients with endometriosis are taken as one cycle. To test t
Slide 39: OS ~FSN-013 (ASEAN)
4 OS ～FSN-013（ASEAN） ASEAN Thailand Indications : Contraception Stage： Applied for import license of FSN-013 ⚫ September 2021：Applied for import license of FSN- in Thailand 013 in Thailand（Accepted in November 2021） Approved in the US and Europe ⚫ Sale & market by OLIC ⚫ Approval procedure is procee
Slide 40: BS ~Market and strategy
5 BS ～Market and strategy ◼ Fuji’s Strategy ◼ Market ⚫ Series of product candidates through ⚫ In recent years, sales of biopharmaceuticals have alliances with Alvotech expanded rapidly. Biopharmaceuticals are generally expensive, which is said to be one of the factors ⚫ Alvotech, which has many fore
Slide 41: BS ~Pipelines
5 BS ～Pipelines ⚫ Following the partnership agreement with Alvotech to commercialize biosimilars in Japan (Nov. 2018), we discussed seven drugs for autoimmune diseases, malignant neoplastic diseases, etc. (total market size in Japan: 250 billion yen). ⚫ Among them, five products have been agreed, an
Slide 42: Appendix
Appendix ©2021 Fuji Pharma Co., Ltd. All rights reserved. 42
Slide 43: Summary of consolidated financial statements for the past five periods
Summary of consolidated financial statements for the past five periods （comparison of old and new accounting standards） New accounting FY9/17 FY9/18 FY9/19 FY9/20 FY9/21 (\million) standards Full Year Full Year Full Year Full Year Full Year Net Sales 33,850 36,090 34,391 32,304 32,645 Gross Profit 1
Slide 44: COGS, SG&A, and R&D expenditure ratios trends
COGS, SG&A, and R&D expenditure ratios trends（New accounting standards） （¥ million） 40,000 70.0% 35,000 60.0% 62.8% 61.8% 61.1% 60.8% 59.6% Consolidated Sales 58.6% 59.0% 30,000 50.0% COGS Ratio 25,000 40.0% 20,000 30,274 32,972 33,850 36,090 34,391 32,304 32,645 35,966 SG&A Expense Ratio 30.0% （Exc
Slide 45: Impact of Drug price revisions
Impact of Drug price revisions Drug price revision rate（Drug cost base） Our drug price revision rate (%) 0.0 ▲ 1.4 ▲ 1.0 * *▲ 2.65 ▲ 2.40 ▲ 2.0 ▲ 3.0 ▲ 4.0 ▲ 6.00 ▲ 5.57 ▲ 5.0 * ▲ 4.38 ▲ 5.75 ▲ 5.8 ▲ 6.0 ▲ 6.7 * ▲ 5.5 ▲ 7.0 ▲ 6.2 ▲ 8.0 ▲ 7.48 ▲ 7.7 ▲ 7.7 ▲ 7.8 ▲ 9.0 2010 2012 2014 2016 2018 2019 202
Slide 46: FSN-011-01: Outline of Japan Phase III Clinical Study
FSN-011-01：Outline of Japan Phase III Clinical Study To evaluate inhibitory effect of endometrial hyperplasia and safety of FSN-011-01 given with Test Purpose estrogen preparation in Japanese women with menopausal disorder with uterus or women with ovarian deficiency symptoms to undergo hormone repl
Slide 47: FSN-013: About Estetrol
FSN-013：About Estetrol Estetrol was discovered in the urine of pregnant women at the 1965 Karolinska Institute. Produced in the liver of higher primate fetuses and translocated through the placenta into the maternal body. Is distributed in fetal plasma at 12-fold the maternal concentration and i
Slide 48: FSN-013: Outline of Japan Phase II (FSN-013-05)
FSN-013：Outline of Japan Phase II（Study No. FSN-013-05） A total of 28 days of administration of FSN-013(Estetrol [E4] 15 mg/drospirenone [DRSP] 3 mg combination tablet) for 24 days followed by placebo tablets for 4 days in patients Test Purpose with endometriosis are taken as one cycle. After admini
Slide 49: Note on forecast and prospects
Note on forecast and prospects The financial forecasts and other projections provided in this presentation are based on information available at the time of its compilation and it therefore contains an element of uncertainty and potential risks. Actual results may differ significantly from these for