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Global Biopharma Outlook 2011: Japanese Pharma
Description:
Innovation is the sole driver for Japan pharma in the short-term, and this Japanese Pharma Outlook for 2011 is largely based around Innovation.
This report identifies and names innovation driven small caps. It finds that some of the large pharma RD pipelines are rich which extends well into individual companies.
The thesis for pure generic companies has played out well for 2009-10 and this research does not see further drivers for this segment until 2012. However, new entrants like Daiichi-Sankyo-ESPHA will emerge as winners in generic space.
Some of the key findings for the Japanese Pharma Outlook 2011 are:
- Generics May Fall Short Of Targets for 2012: We find that major drivers for generics pick-up; those introduced in April-10 have already played out. We expect generics penetration to reach 25% (by vol.) by 2012 (the government's target is 30%).
- Japanese Companies have Lost Their ‘Cash Rich' Status: With the exception of Takeda, none of the Japanese companies carry 15% of their market-value in form of cash. Two years ago Japan pharma Inc. used to have cash equal to 30% of their aggregate Mcap.
- Antihypertensive Are Shrinking; Cancer is Growing: Analysis of Crecon Inc.(leading pharma research agency) data suggests that antihypertensive continue to be largest Thx class in Japan (with 17% of the share), however due to heavy price cuts their value share will shrink. Cancer remains second largest segments (10%) and will grow due to new product launches, premium pricing and intro of biologics.
- Hidden Jewels – Introduction of Japanese Biotech: From our scanning of the Japanese small cap and rising star (unprofitable bio-pharmaceutical companies); we learn that Torii, Zeria, Sosei have good R&D. Each of these companies have at least one compound that is addressing novel mechanism, unmet need and carry potential to change the shape of the company. We also initiate coverage of Torii as Outperform.
- No Political Surprise Intervention to Healthcare Policy Likely Until 2012: The DPJ (Democratic Party of Japan) has already eliminated fears regarding drastically changing the healthcare policies introduced by their predecessor LDP, and followed the same trajectory of targeting healthcare to curb cost. We do not see any near term change in on-going policies/ reforms at least until 2012.
- Change In 80% Rule May Be Realized By 2012 – Significance for Select Drugs Only: ‘Price maintenance system' implemented from April-2010 introduced 80% rule to decide price of branded drugs. Under this, after price cuts, the new price is divided by 0.8 and the new price is compared to the older price (before the price cut impact). The lower price is taken as new price of the drug. There has been news flow that the divisor 0.8 can be increased – this will lower the spectrum of price and may be negative for some drugs.
- Consolidation in Japanese Generics May Start: Foreign/ non-generic companies have started taking Japanese generics as one of their growth drivers. Formation of Daiichi Sankyo ESPHA and entry of global generics in Japan will force existing Japanese generic companies to search for a creative defence. Sawai-Kyorin could perhaps be such a defensive-model too.
This report identifies and names innovation driven small caps. It finds that some of the large pharma RD pipelines are rich which extends well into individual companies.
The thesis for pure generic companies has played out well for 2009-10 and this research does not see further drivers for this segment until 2012. However, new entrants like Daiichi-Sankyo-ESPHA will emerge as winners in generic space.
Some of the key findings for the Japanese Pharma Outlook 2011 are:
- Generics May Fall Short Of Targets for 2012: We find that major drivers for generics pick-up; those introduced in April-10 have already played out. We expect generics penetration to reach 25% (by vol.) by 2012 (the government's target is 30%).
- Japanese Companies have Lost Their ‘Cash Rich' Status: With the exception of Takeda, none of the Japanese companies carry 15% of their market-value in form of cash. Two years ago Japan pharma Inc. used to have cash equal to 30% of their aggregate Mcap.
- Antihypertensive Are Shrinking; Cancer is Growing: Analysis of Crecon Inc.(leading pharma research agency) data suggests that antihypertensive continue to be largest Thx class in Japan (with 17% of the share), however due to heavy price cuts their value share will shrink. Cancer remains second largest segments (10%) and will grow due to new product launches, premium pricing and intro of biologics.
- Hidden Jewels – Introduction of Japanese Biotech: From our scanning of the Japanese small cap and rising star (unprofitable bio-pharmaceutical companies); we learn that Torii, Zeria, Sosei have good R&D. Each of these companies have at least one compound that is addressing novel mechanism, unmet need and carry potential to change the shape of the company. We also initiate coverage of Torii as Outperform.
- No Political Surprise Intervention to Healthcare Policy Likely Until 2012: The DPJ (Democratic Party of Japan) has already eliminated fears regarding drastically changing the healthcare policies introduced by their predecessor LDP, and followed the same trajectory of targeting healthcare to curb cost. We do not see any near term change in on-going policies/ reforms at least until 2012.
- Change In 80% Rule May Be Realized By 2012 – Significance for Select Drugs Only: ‘Price maintenance system' implemented from April-2010 introduced 80% rule to decide price of branded drugs. Under this, after price cuts, the new price is divided by 0.8 and the new price is compared to the older price (before the price cut impact). The lower price is taken as new price of the drug. There has been news flow that the divisor 0.8 can be increased – this will lower the spectrum of price and may be negative for some drugs.
- Consolidation in Japanese Generics May Start: Foreign/ non-generic companies have started taking Japanese generics as one of their growth drivers. Formation of Daiichi Sankyo ESPHA and entry of global generics in Japan will force existing Japanese generic companies to search for a creative defence. Sawai-Kyorin could perhaps be such a defensive-model too.
Contents:
Global Bio-Pharma Outlook 2011 - Japanese Pharma
Industry Capsules
Astellas : Drivers of oncology yet to be proven
Oncology Pipeline
Pipeline has good candidates, but carries certain concerns
- Mirabegron safety issues raise concernsover maintaining leadership in urinary franchise
- Acotiamide market potential is limited to Japan only
- Darexaban is filed in Japan for VTE, but growing competition limits expectations
- Vibativ keeps on lingering; a pricey deal for Astellas
- ASP-1941 appearing as strong candidate in SGLT-2 Inhibitors
China to get the highest attention among BRIC countries
Key Milestones
Appendix 1 MDV3100 early data has shown good results
Appendix 2 Monthly Sales Trend
Chugai
- Dependence on long listed products
- Actemra sales is ramping up well in US/ EU
- Key Milestones
Appendix 1 Monthly Sales Trend
Daiichi Sankyo
Geographic diversity and platform leverage of emerging markets
- Table 1 Geographical Presence
- Table 2 Presence In Emerging Markets
- Table 3 Sales - Region wise
- Revenue base relatively sustainable compared to peers
Domestic Business
OTC Business
- Table 4 Key product sales-Through 2017
- Table 5 Patent expiry calendar in Japan thru 2017
- Table 6 Exposure to long listed products
Global Business
- Ability to exploit Japanese generic opportunity
- Daiichi Sankyo Espha (DSE) - A Game Changer in Japan Generics Market
- Table 8 Low hanging fruits for Daiichi Sankyo Espha
Ranbaxy Para IV opportunity
- Aricept, Valcyte, Lipitor, Diovan Recently approved drug
Laninamivir, Effient
Key Pipeline Candidates
- Edoxaban, ARQ-197, Denosuma
Key Milestones
Appendix 1 Monthly Sales Trend
Appendix 2 Patent expiry through 2013
Appendix 3 Ranbaxy DMF list
Dainippon Sumitomo
Latuda addressing high unmet need in Antipsychotics Market
Anti-Psychotics Market and Competitive Landscape
Latuda Swot Analysis
Next pipeline attraction after Latuda
Key Milestones
Appendix 1 Monthly Sales Trend
Eisai
Aricept Lifecycle Management Programs
Halaven Approved But Has Narrow Target Population
Late stage pipeline candidates
- Eritoran
Appendix 1 Monthly Sales Trend
Kyorin
Sales Growth from its mainstream products
Late stage pipeline is weak Key Milestones
Appendix 1 Monthly Sales Trend
Kyowa Hakko Kirin
Pharma business remains sluggish
Non-pharma business growth offsets Pharma sales decline to some extent
Table 1 Segment Classification
Kyowa Hakko Kirin's antibody pipeline
Table 2 Potelligent Technology
Key Milestones
Appendix 1 Monthly Sales Trend
Mitsubishi Tanabe
Gilenya addresses a huge unmet need in the MS market
Table 1 MS Marketed Products
Existing products to withstand the generic threat
Late stage pipeline is good
- MP-146 (uremic toxin absorbent)
- MCI-196 (phosphate binder)
- TA-1790 (PDEs inhibitor)
- Roflumilast (PDE4 inhibitor)
- Golimumab (anti-TNF mAb)
- Telaprevir (protease inhibitor)
Key Milestones
Appendix 1 Monthly Sales Trend
Shionogi
Crestor sales
The domestic business is safe compared to peer group
US Subsidiary sales deterioration concerns are over
Table 1 Near term patent threats are over
Late stage R&D projects
- S/GSK-1349572 (Integrase inhibitor, HIV infection)
- Ospemifene
- Velneperit/S-3367
- PSD 502
Key Milestones Appendix 1 Monthly Sales Trend
Takeda
Growth from existing products like Actos and Velcade
Actos Patent litigation
Rich late stage pipeline and expected approval through 2012
- Contrave
- Azilsartan
- Hematide
- Alogliptine
World's most cash rich pharmaceutical company
Expected acquisition in emerging market
Key Milestones
Appendix 1 Monthly Sales Trend
Appendix 2 Para IV list
Nippon Chemiphar
- Lowest Profitability Structure Is Not Going To Change Soon
Sawai
- Generic Penetration Has Reached Upper Level For Near Term
- Strong position among generics will be maintained
- Ambitions beyond conventional generic business
- No visibility on utilization of raised debt
- Competition from Big Players
Towa
- Modest Sales sustainability from Dispensing Pharma
- Current capacity can sustain the growth
- Capex can negatively impact its Margins
Torii Pharma
- Driving factors for dalcetrapib success
- Difference between CETP inhibitor/modulator
- Dalcetrapib development programme
- Competitive landscape of CETP inhibitors
- Managing Dyslipidemia with CETP inhibition
- Key Milestones
Industry Capsules
Astellas : Drivers of oncology yet to be proven
Oncology Pipeline
Pipeline has good candidates, but carries certain concerns
- Mirabegron safety issues raise concernsover maintaining leadership in urinary franchise
- Acotiamide market potential is limited to Japan only
- Darexaban is filed in Japan for VTE, but growing competition limits expectations
- Vibativ keeps on lingering; a pricey deal for Astellas
- ASP-1941 appearing as strong candidate in SGLT-2 Inhibitors
China to get the highest attention among BRIC countries
Key Milestones
Appendix 1 MDV3100 early data has shown good results
Appendix 2 Monthly Sales Trend
Chugai
- Dependence on long listed products
- Actemra sales is ramping up well in US/ EU
- Key Milestones
Appendix 1 Monthly Sales Trend
Daiichi Sankyo
Geographic diversity and platform leverage of emerging markets
- Table 1 Geographical Presence
- Table 2 Presence In Emerging Markets
- Table 3 Sales - Region wise
- Revenue base relatively sustainable compared to peers
Domestic Business
OTC Business
- Table 4 Key product sales-Through 2017
- Table 5 Patent expiry calendar in Japan thru 2017
- Table 6 Exposure to long listed products
Global Business
- Ability to exploit Japanese generic opportunity
- Daiichi Sankyo Espha (DSE) - A Game Changer in Japan Generics Market
- Table 8 Low hanging fruits for Daiichi Sankyo Espha
Ranbaxy Para IV opportunity
- Aricept, Valcyte, Lipitor, Diovan Recently approved drug
Laninamivir, Effient
Key Pipeline Candidates
- Edoxaban, ARQ-197, Denosuma
Key Milestones
Appendix 1 Monthly Sales Trend
Appendix 2 Patent expiry through 2013
Appendix 3 Ranbaxy DMF list
Dainippon Sumitomo
Latuda addressing high unmet need in Antipsychotics Market
Anti-Psychotics Market and Competitive Landscape
Latuda Swot Analysis
Next pipeline attraction after Latuda
Key Milestones
Appendix 1 Monthly Sales Trend
Eisai
Aricept Lifecycle Management Programs
Halaven Approved But Has Narrow Target Population
Late stage pipeline candidates
- Eritoran
Appendix 1 Monthly Sales Trend
Kyorin
Sales Growth from its mainstream products
Late stage pipeline is weak Key Milestones
Appendix 1 Monthly Sales Trend
Kyowa Hakko Kirin
Pharma business remains sluggish
Non-pharma business growth offsets Pharma sales decline to some extent
Table 1 Segment Classification
Kyowa Hakko Kirin's antibody pipeline
Table 2 Potelligent Technology
Key Milestones
Appendix 1 Monthly Sales Trend
Mitsubishi Tanabe
Gilenya addresses a huge unmet need in the MS market
Table 1 MS Marketed Products
Existing products to withstand the generic threat
Late stage pipeline is good
- MP-146 (uremic toxin absorbent)
- MCI-196 (phosphate binder)
- TA-1790 (PDEs inhibitor)
- Roflumilast (PDE4 inhibitor)
- Golimumab (anti-TNF mAb)
- Telaprevir (protease inhibitor)
Key Milestones
Appendix 1 Monthly Sales Trend
Shionogi
Crestor sales
The domestic business is safe compared to peer group
US Subsidiary sales deterioration concerns are over
Table 1 Near term patent threats are over
Late stage R&D projects
- S/GSK-1349572 (Integrase inhibitor, HIV infection)
- Ospemifene
- Velneperit/S-3367
- PSD 502
Key Milestones Appendix 1 Monthly Sales Trend
Takeda
Growth from existing products like Actos and Velcade
Actos Patent litigation
Rich late stage pipeline and expected approval through 2012
- Contrave
- Azilsartan
- Hematide
- Alogliptine
World's most cash rich pharmaceutical company
Expected acquisition in emerging market
Key Milestones
Appendix 1 Monthly Sales Trend
Appendix 2 Para IV list
Nippon Chemiphar
- Lowest Profitability Structure Is Not Going To Change Soon
Sawai
- Generic Penetration Has Reached Upper Level For Near Term
- Strong position among generics will be maintained
- Ambitions beyond conventional generic business
- No visibility on utilization of raised debt
- Competition from Big Players
Towa
- Modest Sales sustainability from Dispensing Pharma
- Current capacity can sustain the growth
- Capex can negatively impact its Margins
Torii Pharma
- Driving factors for dalcetrapib success
- Difference between CETP inhibitor/modulator
- Dalcetrapib development programme
- Competitive landscape of CETP inhibitors
- Managing Dyslipidemia with CETP inhibition
- Key Milestones
Companies Mentioned
- Astellas
- Chugai
- Daiichi Sankyo
- Dainippon Sumitomo
- Eisai
- Kyorin
- Kyowa Hakko Kirin
- Mitsubishi Tanabe
- Shionogi
- Takeda
- Nippon Chemiphar
- Sawai
- Towa
- Torii Pharma
- Chugai
- Daiichi Sankyo
- Dainippon Sumitomo
- Eisai
- Kyorin
- Kyowa Hakko Kirin
- Mitsubishi Tanabe
- Shionogi
- Takeda
- Nippon Chemiphar
- Sawai
- Towa
- Torii Pharma
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