KYORIN Pharmaceutical Co.,Ltd. · TSE:4569
KYORIN Pharmaceutical Co.,Ltd — FY2020 Earnings Presentation
36 slides from KYORIN Pharmaceutical Co.,Ltd's earnings presentation, May 12, 2021
Slide 1: Financial Results for Fiscal Year 2020
Financial Results for Fiscal Year 2020 May 12 , 2021 KYORIN Holdings, Inc. Representative Director, President and Chief Executive Officer Yutaka Ogihara
Slide 2: Outline of Consolidated Financial Results
➢Outline of Consolidated Financial Results ・Trends of mainstay products ➢Consolidated Financial Forecast ➢Status of R&D Pipeline ➢Initiatives toward realization of the long-term vision “HOPE 100” ・Medium-Term Business Plan “HOPE 100-Stage3-”(Fiscal Year 2020～2023） 2
Slide 3: Impact of COVID-19 on our Business
Impact of COVID-19 on our Business ■Promotion Activities etc. Although it is predicted the impact on sales activities will decrease after October 2020, promotion activities was affected by the state of emergency due to the arrival of the third wave ・Patient’s suppressive behavior to medical consulta
Slide 4: Outline of Consolidated Financial Results
Outline of Consolidated Financial Results 4
Slide 5: Breakdown of Gain and Loss
Breakdown of Gain and Loss Change （Units: ¥billion） Change (forecast) FY 2019 FY 2020 Change Announced on (%) Nov 5,2020 Sales 110.0 102.9 －7.1 －6.4 －5.1 New ethical drugs, etc. 77.5 69.7 －7.8 －10.1 －4.1 （Japan） New ethical drugs（Overseas） 1.5 1.0 －0.5 －33.2 －0.1 Generic drugs 31.0 32.2 ＋1.2 ＋3.9 －0
Slide 6: Highlights of Business Performance: Net sales
Highlights of Business Performance:①Net sales （Units: ¥billion） 120.0 110.0 【Net Sales ¥－7.1 bln】 102.9 100.0 New ethical drugs, etc.(Japan) 31.0 ¥－7.8 bln ・Market shrinkage due to new coronavirus infection 32.2 ・Sales decrease due to NHI drug price revision 80.0 (Kyorin Pharmaceutical 2% range) 1.5
Slide 7: Highlights of Business Performance: Income
Highlights of Business Performance ②（Income） (Units: ¥ billion) 【Operating Income ¥－1.7 bln】 8 Gross Profit ー¥5.4 bln Net Sales： Decreased ¥7.1bln year on year Cost of sales ratio : 6 Increased 1.7% year on year ・Impact of NHI price revision －5.4 ・Increase in generic sales ratio ー2.4 4 7.5 R&D expen
Slide 8: Highlights of Business Performance ③
Highlights of Business Performance ③ （Change : Revised forecast) Change (Forecast) （Units：¥billion） FY 2019 FY 2020 Change Change(%) Announced in Nov 5,2020 Net Sales 110.0 102.9 －7.1 －6.4 －5.1 New ethical drugs, etc.(Japan) 77.5 69.7 －7.8 －10.1 －4.1 New ethical drugs (Overseas) 1.5 1.0 －0.5 －33.2 －
Slide 9: Main Product Sales Update
Main Product Sales Update （単位：億円） Change (forecast) FY 2019 FY 2020 Change Change(%) Announced on Nov 5,2020 Flutiform (Combination drug for asthma treatment) 14.6 13.3 －1.3 －9.0 －1.2 Desalex (Antiallergic Agent) 2.6 5.7 ＋3.1 ＋120.7 －1.8 Beova (β3 adrenergic receptor agonist overactive bladder thera
Slide 10: Trends of mainstay products and Generic drugs
Trends of mainstay products and Generic drugs 10
Slide 11: Flutiform (Anti-asthmatic)
■Mainstay product Flutiform（Anti-asthmatic） ICS/LABA market Market Sales Sales （Units: bln） Flutiform share （%） 140.0 20 14 120.0 15.5 12 13.2 15 100.0 12.2 10 11.4 80.0 9.7 8 10 14.6 13.9 123.2 13.1 13.3 60.0 113.6 115.1 120.3 6 11.9 101.3 40.0 5 4 20.0 2 0.0 0 0 17/3 18/3 19/3 20/3 21/3 18/3 19/3
Slide 12: Desalex (Antiallergic Agent)
■Mainstay product Desalex (Antiallergic Agent) (Units: ¥ billion) (Units: ¥ billion) Antihistamine market New drugs long-listed drugs and generics Approx. Desalex share Sales 15.0 200.0 173.5 178.2 180.0 8 162.1 156.2 160.0 137.0 10.0 140.0 6 Supply suspended : 100.0 about 10 months 106.8 95.7 120.0
Slide 13: Beova / Uritos (Therapeutic agent for overactive bladder)
■Mainstay product Beova / Uritos (Therapeutic agent for overactive bladder) (Units: ¥ billion) OAB market (Units: ¥ billion) (%) β3 receptor antagonist others Sales 10.4 10.5 anticholinergic agent Beova share 10.1 Imidafenacin 100 96.3 97.7 20 10 0.7 0.7 AG 90.2 91.0 91.3 80 8 4.3 40.2 15 7.2 7.3 47
Slide 14: Lasvic (New quinolone synthetic antibacterial agent)
■Mainstay product Lasvic (New quinolone synthetic antibacterial agent) (Units: ¥ billion) (Units: ¥ billion) Oral antibacterial agent market 3 150 Sales 100 2 144.6 125.9 2.8 50 105.6 96.2 1 63.3 1.1 0.9 0 17/3 18/3 19/3 20/3 21/3 0 20/3 21/3 22/3 ※Copyright© 2021 IQVIA. calculated based on MIDAS Ma
Slide 15: Status of Generic Drugs
■Status of Generic Drugs Kei (Units: ¥ billion) 35 33.1 ◼Status of FY2020 32.2 0.7 IMIDAFENACIN ⚫Released of Imidafenacin AG(June) 31.0 0.7 AG 30 29.3 3.5 ⚫Montelukast AG, Mometasone AG, Imidafenacin 2.8 MOMETASONE 27.7 3.8 AG AG maintain the market share of more than 50% in the GE market ●Released
Slide 16: Consolidated Financial Forecast
Consolidated Financial Forecast 16
Slide 17: Consolidated Financial Forecast for the Year Ending March 2022
Consolidated Financial Forecast for the Year Ending March 31, 2022 (Units: ¥ billion) FY2021 Y/Y FY2020 （forecast） Change Change(%) Net 102.9 102.6 n/a n/a sales New ethical drugs, etc.(Japan) 69.7 68.6 n/a n/a New ethical drugs (Overseas) 1.0 0.8 n/a n/a Generic drugs 32.2 33.1 n/a n/a Cost of Sale
Slide 18: Forecast of Mainstay Products Sales
Forecast of Mainstay Products Sales FY2020 FY2021 YoY （Units：¥billion） (Actual) (Forecast) Change Change(%) Flutiform (Combination drug for asthma treatment) 13.3 13.9 ＋0.6 ＋4.8 Desalex (Antiallergic Agent) 5.7 7.2 ＋1.5 ＋27.2 Beova(Kyorin) (β3 adrenergic receptor agonist overactive bladder therapeut
Slide 19: Shareholder Returns
Shareholder Returns Capital Policy ・While maintaining the sound financial base, we aim to improve the capital efficiency through growth investment and returns to shareholders ・We will maintain stable dividends taking DOE (Dividend on Equity ratio) into account Revision of Dividend Level In considera
Slide 20: Status of R&D pipeline
_Kyorin 2) Status of R&D pipeline 20
Slide 21: Drug R&D Pipeline: Progress in FY2020
Drug R&D Pipeline: Progress in FY2020 Progress in FY2020 Approval/ development code PhⅠ PhⅡ PhⅢ application Launch KRP-108P Pediatric Indication (Jun) Respiratory KRP-R120 (Jul) Infections KRP-AM1977Y Launched (Mar) KRP-116D Approved (Feb) Urology AKP-009 ASKA in progress ● Gefapixant citrate: MSD：P
Slide 22: Drug R&D Pipeline: Progress in FY2021
Drug R&D Pipeline: Progress in FY2021 Progress in FY2021 development code PhⅠ PhⅡ PhⅢ application Approval / Launch KRP-R120 Respiratory Gefapixant MSD(2021) citrate KRP-A218 (Apr) Infections KRP-116D Launched (Apr) AKP-009 ASKA in Urology progress ※ Gefapixant citrate: Concluded Distribution Agreem
Slide 23: Progress of Medium-Term Business Plan HOPE 100-Stage 3-
Progress of Medium-Term Business Plan “HOPE 100-Stage 3-” (Fiscal Year 2020～2023) 23
Slide 24: Overview of Medium-Term Business Plan HOPE 100-Stage 3-
Overview of Medium-Term Business Plan “HOPE 100-Stage 3-” Statement : Realize growth trend by pursuing Kyorin’s originality ・Shift to business based on the proposal of solutions and accelerate the growth of new drug groups. ・ Enhance pipeline to support medium-term growth Business Strategy ・ Strengt
Slide 25: Solution Provision Activities in Infection Domain
Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Solution Provision Activities in Infection Domain “Lasvic IV Drip Infusion Kit 150mg” Response to changing environment launched (Mar) （MR activities/Medical care provision system） ・Contribute to respira
Slide 26: Main products' medium-term growth
Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Main products’ medium-term growth Medium-term management plan “HOPE100－Stage 3－” Accelerate new drugs group as much as possible Market Product Market environment/ share Current Status (FY2020) Vision na
Slide 27: Accelerate growth of new drug groups
Shift to business based on the proposal of solutions and accelerate the growth of new drug groups Accelerate growth of new drug groups ◼ Maximize the spread of Flutiform and Desalex ◼ Establish Lasvic’s position as a quinolone for respiratory and otolaryngological infections ◼ Accelerate growth of B
Slide 28: New quinolone synthetic antibacterial agent Lasvic
Enhance pipeline to support medium-term growth New quinolone synthetic antibacterial agent ”Lasvic” Lasvic Tablets 75mg Launched in Jan 2020 ■Indication Pharyngitis, stomatitis, tonsillitis (including peritonsillitis and peritonsillar abscess), acute bronchitis, pneumonia, secondary infection of chr
Slide 29: Interstitial cystitis Zymso Intravesical Solution 50%
Enhance pipeline to support medium-term growth Interstitial cystitis “Zymso® Intravesical Solution 50%” Indication Improvement of symptoms of interstitial cystitis (Hunner type) (chronic pelvic pain, pressure and discomfort associated with the bladder, lower urinary tract symptoms such as increased
Slide 30: Gefapixant Citrate a Treatment for Chronic Cough
Enhance pipeline to support medium-term growth “Gefapixant Citrate” a Treatment for Chronic Cough Agreement with MSD Date of agreement: Apr 2021 (Press release Apr 26, 2021) Essence of agreement : Exclusive distribution rights in Japan Development status Application submitted by MSD in Feb 2021 Targ
Slide 31: Strengthen drug discovery capability to realize innovative new drugs
Strengthen drug discovery capability to realize the creation of innovative new drugs Cooperation Watarase Research Center ActivX(USA) Open innovation Open innovation Academia, Venture Pharmaceutical companies in Japan and overseas Selection and Concentration Drug discovery Priority study area Outsid
Slide 32: KPR-A218 a Treatment for Rhinovirus infection
Strengthen drug discovery capability to realize the creation of innovative new drugs “KPR-A218” a Treatment for Rhinovirus infection Development background Discovered from Kinase research by Watarase Drug Discovery Center and ActivX in the United States Development status Started PhⅠ in Apr 2021 in
Slide 33: Improve cost competitiveness at KYORIN Pharmaceutical Group Facilities
Improve cost competitiveness Reform cost structure through intra-group optimization Improve cost competitiveness at KYORIN Pharmaceutical Group Facilities Co., Ltd ◆ Control outsourcing expenses by equalizing the manufacturing capabilities of each factory ◆ Facilitate efficient operation through the
Slide 34: Increase Business speed and Cost competitiveness
Key point of Business Strategy in FY 2021 Increase Business speed and Cost competitiveness
Slide 35: Disclaimer
Disclaimer These forecast performance figures are based on information currently available to the Company and may include uncertain factors or risk that affect our future performance. Accordingly, actual business results may materially differ from the forecasted figures due to various factors in the
Slide 36: Kyorin @)
Kyorin @) Kyorin ©)