Financial Results for the 2Q/FY 2009 Ending March 31, November 6, 2009 Masafumi Nogimori President and CEO Astellas Pharma Inc.

Transcription

1 Financial Results for the 2Q/FY 2009 Ending March 31, 2010 November 6, 2009 Masafumi Nogimori President and CEO Astellas Pharma Inc.

2 Cautionary Statement Regarding Forward-Looking Information This material includes forward-looking statements based on assumptions and beliefs in light of the information currently available to management and subject to significant risks and uncertainties. Actual financial results may differ materially depending on a number of factors including adverse economic conditions, currency exchange rate fluctuations, adverse legislative and regulatory developments, delays in new product launch, pricing and product initiatives of competitors, the inability of the company to market existing and new products effectively, interruptions in production, infringements of the company s intellectual property rights and the adverse outcome of material litigation. This material contains information on pharmaceuticals (including compounds under development), but this information is not intended to make any representations or advertisements regarding the efficacy or effectiveness of these preparations nor provide medical advice of any kind. 1

3 Summary of Financial Results for 2Q/FY2009 (billion yen) Net sales COG COG ratio SGA SGA ratio R&D R&D ratio OP OP ratio Ordinary income 2Q/08 Actual % % % % Q/09 Actual % % % % Change ppt ppt ppt ppt Q/09 Forecasts Difference Factors (Changes from 2Q/08 actual) Expansion of sales of current products Forex impact by Product mix +0.7ppt Relative increase of weight for product sale in Japan due to forex impact Decrease due to forex impact Decrease due to forex impact Decrease in in-license fee by 7.6 Increase of clinical development costs Increase in depreciation of new research facilities in Japan Forex impact by Decline in interest income Carrying of currency exchange loss Net income Improvement of special losses Improvement of tax rate Forex USD EUR 2Q/ yen 163 yen 2Q/09 95 yen 133 yen Change forecasts 100 yen 130 yen 2

4 Sales by Geographical Area -Sales Increase globally on a local currency basis- 2Q/08 Japan 日本 ( ( billion) 億円 ) Q/08 Europe 812 ( million) 2Q/ (+2.9%) 2Q/ (+12.2%) Factors Lipitor +2.3 Micardis/Micombi +4.4 Gaster -1.1 Prograf +2.6 Vesicare +1.7 Celecox +2.9 Factors Prograf/Advagraf +26 (export sales included) Harnal +2 Harnal Bulk & Royalty +64 Vesicare +15 Protopic +2 Mycamine +2 Eligard +9 2Q/08 North America 902 ($ million) 2Q/08 Asia 14.5 ( billion) 2Q/ (+15.9%) 2Q/ (+6.2%) Factors Prograf +34 Scan +57 AmBisome +3 VESIcare +34 Mycamine +16 Factors Prograf +0.7 Vesicare +0.1 Mycamine +0.2 Forex impact 3.0 3

5 Vesicare ( billion) Asia Europe North America Japan 2Q/09 Growth Rate Japan: 20% North America: 23% (USD) Europe: 23% (EUR) Asia: 87% (local currency) Market Share Japan : 45% (2Q/09, NHI Drug price basis) US : 18% (TRx, Week of Oct 16, 09) Europe : 32% (Aug 09 YTD, cash basis) Q/07 2Q/08 2Q/09 Launched: More than 50 countries/areas China (expected in Jan 10) 4

6 Fungard/Mycamine ( billion) Asia Europe North America Japan 2Q/09 Growth Rate Japan : 2% North America : 81% (USD) Europe: 2 million (actual sales) Asia : 116% (local currency) Q/07 2Q/08 2Q/09 Market Share Japan : 51%* (2Q09; NHI Drug price basis) US : 51%** (Aug 09) Launched: More than 30 countries/areas Europe : Launched in 17 countries? Indonesia (launched in Oct 09) India (expected in early CY10, licensed to GSK) * NHI Drug Price basis in antifungal injection market. **Pt-days share among 3 candin agents according to Wolters Kulwer. 5

7 Prograf Q/07 2Q/08 2Q/09 ( billion) Q/09 Growth Rate Export Asia Europe North America Japan Japan: 19% North America : 8% (USD) Europe : 12% (EUR) Asia : 30% (local currency) Topics Japan Additional indication for ulcerative colitis (July 09) Additional indication for myasthenia gravis (Oct 09) US TRx share: KTx 90%, LTx89%, HTx76% (CNI, May 09) Generic launched in Aug 09 EU Sales of Advagraf: 43M Generic products approved in Sep 09 (in 4 countries including Germany, Netherlands, etc.) Asia Advagraf: Korea (launched in Oct 09) 6

8 Harnal ( billion) Bulk and Royalty Asia Europe Japan 2Q/09 Growth Rate Japan : 1% Europe : 3% (EUR) Asia : 23% (local currency) Bulk and Royalty : 45% (EUR) Q/07 2Q/08 2Q/09 US Flomax Sales : $619M (3Q/CY09, +29%) TRx Share: 48% (Aug 09) Received notice from FDA that pediatric data satisfactorily met Written Request Market exclusivity extends to Apr 2010 Estimate generic products to enter market in early Mar 10 TOCAS Sales in Europe : 63MM Launched in Maleysia (July 09) and Singapore (Sep 09) 7

9 Japan : Sales of Major Products Japan ( billion) Total Rx Lipitor Micardis/Micombi Gaster Harnal Prograf Myslee Seroquel Vesicare Celecox Geninax Irribow Bonoteo 2Q/ Q/ Change (%)

10 North America: Sales of Major Products North America ($ million) Total Rx Prograf VESIcare Scan (Adenoscan+Lexiscan) Mycamine AmBisome Protopic Amevive Vaprisol 2Q/ Q/ Change (%)

11 Europe: Sales of Major Products Europe ( million) 2Q/08 2Q/09 Change(%) Total Rx Harnal Sales by Astellas Bulk and Royalties Prograf Vesicare Protopic Mycamine Eligard

12 Revised Full Year Forecasts for FY2009 (billion yen) FY2008 Actual FY2009 Revised forecasts (A) Change FY2009 Initial forecasts (B) Variance (A)-(B) Net sales % R&D R&D ratio % % +12.5% % OP % Ordinary income % Net income % Forex (average) *Initial forecasts: announced in May 2009 USD 101 yen 93 yen yen EUR 143 yen 132 yen yen **Forex forecasts for 3Q&4Q/09: 90yen/USD, 130yen/EUR 11

13 Revised Full Year Forecasts for FY2009: Factors for Change in Net Sales 9, , Initial forecasts for FY2009 (billion yen) Revised forecasts for FY2009 Factors for change in net sales [Upward factors] Vaccine in Japan (new-type and seasonal influenza) billion yen Harnal +2.9 billion yen Celecox +2.0 billion yen [Downward factors] Prograf + Advagraf -8.0 billion yen (-15.6 billion yen of those accounts for North America) Earlier expansion of share of generic Prograf than estimated Expect increase in net sales in all areas other than North America Irribow -2.4 billion yen (Forex impact billion yen) 12

14 Revised Full Year Forecasts for FY2009: Factors for Change in OP (billion yen) Factors for change in OP [Upward factors] Growth of sales in existing products Further through cost control Initial forecasts for FY Revised forecasts for FY2009 [Downward factors] Change in forex condition Earlier expansion of share of generic Prograf than estimated Increase in cost for aggressive inlicensing activities 13

15 Global Pipeline

16 Status of Astellas Pipeline Red: Changes from the previous announcement Urology Filed YM617(LUTs, J) : Local : New Indication, New Formulation : In-house Global P3 P2 YM178 (OAB, E, US, J) solifenacin/ tamsulosin (E) YM905(D tablet, J) : Licensed-in Global ASP3652 ASP7035 P1 Transplant Immunology YM177 (Acute pain, J) ASP0485 (E, US) ASP9831 (E) ASP015K (Transplant,US) ASP015K (J) ASKP1240 ASP3291 Anti-Infective telavancin (HAP,US) telavancin (cssti/hap,e) ASP2151 (US, J) telavancin (J) YM150 (VTE, J, A) YM150 (VTE, E, US) Diabetes Cardiology Renal RSD1235 (US) YM086 (Diabetic nephropathy, J) ASP1941 (J) ASP1585 (J) YM533 (Chronic renal failure,j,a) YM150 (AF, E, J, A) YM150 (ACS, E) ASP1941 (US,E) YM311(US)* ASP1517(US)* YM311 (J) * ASP1517 (J) * ASP4178 CNS ASP8825 (Restless legs syndrome, J) ASP2905 ASP0777 FK949E Oncology MDV3100 (Prostate cancer, E,US) ASP3550 (J) AGS 1C4D4 (E, US) YM155 (E, US) ASP0265 AGS-16M18 AGS-8M4 YM155 (J) Others YM443 (J) YM529 (1M, J) YM443 (US) YM060 (E) *Licensed territory: E and J etc., cssti: Complicated Skin and Soft Tissue Infections, HAP: Hospital-acquired Pneumoninia, VTE: venous thromboembolism, AF: atrial fibrillat ACS:Acute Coronary Syndrom 15

17 Progress in Pipeline Status from August 09 (1) Project Indication Area Stage Memo VIBATIV (telavancin) Complicated skin and skin structure infections (csssi) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains USA Approved Approved in September. Approved in Canada in September. Approved in October. Prograf Myasthenia gravis Japan Approved Approved for all types of myasthenia gravis covering those not included in past indication. YM617 (Flomax) Pediatric neurogenic bladder USA - FDA noticed the pediatric data submitted in pediatric patients with neurogenic bladder satisfactorily met the terms of Written Request. telavancin Complicated skin and soft tissue infections (cssti)/nosocomial pneumonia (NP) Europe Filed Filed in October. RSD1235 Atrial fibrillation USA Filed Initiated an additional P3b study. 16

18 Progress in Pipeline Status from August 09 (2) Project Indication Area Stage Memo ASP1941 Type 2 diabetes Japan USA Europe P3 P2b P2b Entry into P3 in Japan Entry into P2b in USA and Europe YM533 Chronic renal failure Japan/Asia P3 Entry into P3 MDV3100 Prostate cancer USA Europe P3 Licensed from Medivation YM150 Acute coronary syndrome Europe P2 P2b initiated in Europe ASP2151 Herpes zoster, Genital herpes USA Japan P2 Suspended development of ASP2151 to investigate serious adverse events observed in a 28- day safety study in healthy subjects. Backup compound concurrently is under consideration. ASP015K Suppression of organ rejection in organ transplant USA Japan P2 P1 P1 completed and entry into P2 in USA. Entry into P1 in Japan. 17

19 Progress in Pipeline Status from August 09 (P1, etc.) New P1 Project Project Indication Stage Memo ASP4178 Type 2 diabetes P1 Entry into P1 (New MOA) Discontinued Project ASK8007(Rheumatoid arthritis) 18

20 Mirabegron (YM178) Development Progress NDA Filing Expected in FY2010 Summary results of P3 in the US and Europe are available. In the US and Europe: NDA filing expected in the 2nd Half of FY2010. P3 in Japan is ongoing. In Japan: NDA filing expected in the 1st Half of FY2010. P3 in Asia initiated (China/Korea/Taiwan). 19

21 Mirabegron (YM178) Summary Results of P3 in the US and Europe Study outline Study design: Double-blind, placebo-controlled study Primary endpoint: Change of number of incontinence episodes per 24-hour and number of micturitions per 24-hour Treatment period: 12 weeks Number of patients in safety analysis: [US]1,328 patients, [Europe] 1,978 patients Results The results of both P3 in the US and Europe showed as below. The study met its objective by demonstrating efficacy for the co-primary efficacy variables compared to placebo in both mirabegron treatment groups. Based on the available top-line safety results, mirabegron appears to be safe and well tolerated. The incidence of anti-cholinergic side effects with mirabegron was low and comparable to those in the placebo group. The Phase 3 results appear sufficient for regulatory submission. 20

22 YM150 Development Progress Clinical trial status ACS: P2b in Europe started. VTE prevention AF US Europe/US Japan/Asia Europe/Japan/Asia P1 P2 P3 P2b completed n=685 (YM150: QD/BID, warfarin) P2b/3 ongoing n=2,000 (YM150: QD/BID, enoxaparin) P3 ongoing 1) TKR n=380, 2) THR n=580, (YM150: BID, placebo, enoxaparin) 3) Hip fracture surgery, 4) Abdominal surgery, 5) Acute medical illness, 6) History of VTE P2b ongoing n=1,280 (YM150: QD/BID, warfarin) ACS Europe P2b initiated n=1,264 (YM150: QD/BID, placebo) ACS P2b study outline Study design: Double-blind, placebo-controlled, dose-finding study Primary endpoint: Major and Clinically Relevant Non Major bleeding events Treatment period: 6 months VTE: Venous Thromboembolism, AF: Atrial Fibrillation, ACS: Acute Coronary Syndrome, THR: Total Hip Replacement, TKR: Total Knee Replacement 21

23 ASP1941 (SGLT2 Inhibitors) Development Progress Japan: Entry into P-3 ASP1941 monotherapy studies and combination studies with other anti-hyperglycemic drugs will be conducted. Two monotherapy studies will be initiated in FY2009. Summary of Monotherapy P3 Pivotal Study Double-blind, placebo-controlled study in type 2 diabetes patients Durations: 16 weeks Primary endpoint: HbA1c Expected enrollment: 120 Summary of Long-term Monotherapy P3 Safety Study Open-label study in type 2 diabetes patients Durations: 52 weeks Primary endpoint: HbA1c Expected enrollment:

24 ASP1941 (SGLT2 Inhibitors) Development Progress US, EU: Entry into P2b US: ASP1941 monotherapy study will be initiated in FY2009. Summary of Monotherapy P2 Dose-Finding Study Double-blind, placebo and active-controlled study in type 2 diabetes patients Durations: 12 weeks Primary endpoint: HbA1c Expected enrollment: approx. 380 EU: Combination study with metformin will be initiated in FY2010. Summary of Metformin Add-On P2 Dose-Finding Study Double-blind, placebo-controlled study in type 2 diabetes patients Durations: 12 weeks Primary endpoint: HbA1c Expected enrollment: approx

25 SGLT2 inhibitors Strengths of SGLT2 inhibitors Reduce hyperglycemia by urinary glucose excretion Reduce body weight Less risk of hypoglycemia and can be combined with all kinds of other oral anti-diabetic agents and insulin Mechanism of action 24

26 Cancer pipeline Project/Product name (Area) Target cancer P-1 P-2 P-3 Launch Eligard(EU) Prostate cancer small molecule antibody MDV3100(EU/USA) ASP3550(Japan) YM155(EU/US/Japan) ASP0265 AGS-1C4D4(EU/USA) AGS-16M18 AGS-8M4 Prostate cancer Prostate cancer Breast cancer, Non-Hodgkin s lymphoma, Melanoma Prostate cancer Pancreatic cancer 25

27 MDV3100 Target position in the treatment of prostate cancer Subject of P-3: Castration-resistant prostate cancer who were previously treated with docetaxel-based chemotherapy. - Use in combination with GnRH agonist. - Use for the resistant patients of current AR antagonist. <Target position of MDV3100> 1st indication of MDV nd line CAB Current medication failure 1 st line CAB failure AR AR antagonist antagonist GnRH GnRH agonist agonist Chemotherapy Chemotherapy failure Post-Chemo CRPC Disease progression GnRH: Gonadotropin releasing hormone, AR:Androgen CAB: Combined androgen blockade, CRPC: Castration-resistant prostate cancer 26

28 Initiatives to Enhance Our Enterprise Value after Aug 09 (1) Co-Promotion Agreement for Symbicort with AstraZeneca in Japan Target Indication: Treatment of bronchial asthma Mechanism: Combination drug of budesonide and formoterol Development stage: Approved in Oct 09 Upfront Payments: 3.0 billion yen TBD Area: Japan Co-Promotion Agreement for Caduet Combination Tablets with Pfizer in Japan Indication: Hypertension or angina and hypercholesterolemia or familial hypercholesterolemia Mechanism: Combination tablets of sustained Ca inhibitor and inhibitor of HMG-CoA reductase Development stage: Approved in July 09 Area: Japan 27

29 Initiatives to Enhance Our Enterprise Value after Aug 09 (2) Target Indication: Prostate cancer Mechanism: A new generation of oral anti-androgen Development stage: Phase 3 in the US and Europe Payments: Upfront for $110M, development milestones up to $335M, commercial milestones up to $320M Area: Worldwide Worldwide Agreement to Commercialize MDV3100 with Medivation Move Fermentation and Biotechnology Labs. to Tsukuba Research Center (Tokodai) Purpose: Positioning Tsukuba Research Center (Tokodai) as a foothold of biotechnology research. To further strengthen new drug discovery capability and accelerate the discovery process by ensuring closer collaboration between drug discovery research and manufacturing process research. Period: Taking place in a phased manner from FY2010 through FY2011. Kiyosu Research Office will be closed in FY2012. Investment: Approx. 7.0 billion yen (pilot plant for process research and facilities to manufacture sample of drug substances, etc.) 28

30 Alliance Activities in FY09 Q1/09 Q2/09 Q3/09 May 09 febuxostat Hyperuricemia in patients with gout Approved August 09 Sumavel TM DosePro TM Migraine, cluster headache P3 October 09 MDV3100 Prostate cancer Approved June 09 Qutenza Peripheral neuropathic pain Approved August 09 Symbicort Bronchial asthma July 09 Establishment of joint venture with Maxygen Approved August 09 Caduet Combination Tablets Hypertension/hyperchole sterolemia 29

31 Initiatives to Increase the Level of Return to Shareholders Share buyback (announced on Nov 5): Amount (maximum): 30.0 billion yen Number of shares (maximum) : 820 million shares Period: Nov 9, 09 to Dec 11, 09 Interim dividend for FY yen per share Annual dividend forecast: 125 yen per share (in line with initial forecast) <Our view in capital efficiency> Top priority on investment in Rx business for growth. Strive to increase dividend payment continuously. Flexible share buyback. Cash balance will be maintained at higher level. 30

32 Mid-term Management Plan (MTP) 2014 Currently formulating MTP beginning in FY2010 and ending FY Taking into account the changing environment, such as internal factors including revision of launch assumption and reorganization of drug discovery functions and external factors including the progression of government policies to restrain medical expenditure, global recession and forex fluctuation, etc. Scheduled announcement for MTP2014 is May