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Global Bio-Pharmaceutical
        OUTLOOK 2011




!   !      B/203, Alkapuri Arcade, R.C.Dutt Road, Vadodara-390007, INDIA.
        Phone: +1|212| 343-6096, +91|265| 232-7096, E-mail: mp@mpadvisor.com
!
Rising Star

What is Going Right For the sector?

What Are the Challenges?

Is investment in innovative therapeutics warranted? Which innovative therapeutics
has or will make an impact on the quality of our lives in the next two to three years?
What therapy areas present investment opportunities?

What events in the sector will win thumbs down or be an outright –ve?


Value creation: Our portfolio and top pick recommendations
What Is Going “Right”?
• Moving beyond the “wait and watch” for Proof-of-Concept (PoC), Big pharma are giving
   importance to Proof-of-Relevance *-Paradigm shift in Partnering Deals: Tap Them Young

• While the HC Reform bill served a blow to profitable Pharma and Biotech companies in US,
   it has boosted the Spirit of Research for the non-profitable biotech/ biopharma companies,
   Rising stars (RS). R&D may turn the corner as Obama has increased the R&D tax credit by
   20% and made it permanent..

• Drug approval in 09 and 2010 was not depressing and some novel approaches have made it
   to the market- Provenge (Prostate cancer vaccine) Prolia (PM, osteoporosis), Gileniya (oral
   MS drug). The report discusses important upcoming regulatory and clinical milestones
*Proof-of-Relevance: To identify the indisputable clinical and commercial value of early stages compounds.
What Are the Challenges?

• Regulatory Pathway and Reimbursements- Our Focused Sector Report discusses
  these in depth
• Biosimilars and Patent Expiry- How Close and Real is the “Bio-generic Era”?
• Safety continues to be the key factor in approval of drugs
• Will Lupus, Obesity, Melanoma etc, See a New Drug?- Analysis and Our Take on
  the Outcome of the regulatory events.
• Binary Events- Another Intermune like Debacle in 2011? Select milestones in 2011
  which could make or break a Company are included in the Report.
Therapy Areas Offering Investment Opportunities
• HCV- Protease Inhibitors to The Rescue - Will sweep the HCV market, as they did in the
  case of AIDS. At least two compounds will be approved (telaprevir, boceprevir) before
  2012. Analysis of the therapy Area and Leading Companies- Vertex, Pharmasset. Market
  Dynamics and unmet Need.

• Autoimmune/ Inflammation diseases have seen the best outcome –both in targeting unmet
  needs and better patient friendly treatment options. Oral drug (INCB28050, R788,
  RDEA594, Gilenya) options are likely to make way for many diseases, such as, RA, MS;
  where injectables and biologics are the only options. Lupus and Gout will finally see
  approval of safer and more efficacious products (RDEA594, Benlysta, Epratuzumab) by
  2011-14.

• Rare Genetic - Orphan diseases continue to be pursued as a preferred area by Innovators -
  premium pricing, low regulatory bar, etc. are incentives. Besides ERT (Enzyme Replacement
  Therapy), drugs for MPN (Myeloproliferative Neoplasms), IPF, HoFH (Homozygous
  Hypercholesterolemia) should be approved by 2011-14.

• Melanoma – MAbs may finally deliver –With 120,000 diagnosis of melanoma annually,
  and 300 agents investigated thus far, it is amazing that effective products for melanoma
  remain elusive. Benlysta Approval???
Mature Biotech


Resembling Global Pharmas and Specialty Pharmas of last decade



       “Is the age of the biotech monopoly about to end ?”
Mature Biotech – Issues
    CY 2010 affected all Pharma companies by “Obamanisation and Implementation of
     the Health Care Reforms (HC)” wiping off their market value significantly in the
     first half of 2010.

• Drying new product launches, thin pipeline and intensifying competition

• New Drugs Approved, but will they boost the sales or is the wait going to be
  longer?

• Patent Expiry Impact is Modest and Built into the Current Price; However outcome
  of Para IV Filing from Global Generic Players can surprise and will remain a
  “Hanging Sword” for the innovator. Report includes the patent expiry, sales table of
  major biologics and regulatory pathway being framed in US and for mAB in EU.

• Life cycle management approach by making better biologics, me toos. Report
  highlights the 2nd generation tools and technologies for making better biologics,
  mAB based drugs.

•
Mature Biotech – Issues
• Discounted pricing for patented follow-on drug launches could become a norm

• Re-imbursement issues:
  • CMS support to MCOs and PBMs for price negotiations should limit pricing
    flexibility
  • Off label re-imbursement cuts
  • German/ EU reference pricing, NICE & Japanese health reforms seeking stringent
    cost control

• FOB or Biosimilars:
  • Coming closer to reality as guidelines already placed in EU and in the works in US.
  • Lack of products to make up for the biosimilar erosion and sales loss.

• M&A and In-licensing remains key for future growth
  • Compete with cash rich Global Pharmas
  • Fewer opportunities with inflated valuation
Silver Lining

• Mature Biotech Can still afford to choose good products in the making…

• Outsourcing is the Mantra for Fueling the Pipeline

• Healthy cash position and depressed valuations = opportunity to buy back
  shares and improve valuations.
Valuation Methodology


• MP Advisors’ Proprietary Sum-of-The-Parts Valuation enables us to quantify the
  difference between the current equity value and the value arrived using our valuation method
  comprising three parts, i.e., Part A, Part B, and Part C as described below:

• Value the marketed products till their respective patent expiries (Part A);

• Value the late stage pipeline as of today (Part B) (Consider only the late stage PhIII and
  registered products).

• Value the management’s ability to convert early stage R&D activities into mainstream
  products and company’s strategic approach- historical and visionary, by giving a premium to
  their future cumulative R&D investment (Part C).

• The difference between the current equity value and Part A plus cash and other income value
  represents the gap that needs to be met through the company’s late stage R&D pipeline (Part
  B) and other strategic efforts (Part C) and drives our recommendations
3Bs:
Biologics, Bio-Generics,
 and Better-biologics:
 A Value Proposition
Dawn of the Biologics/Bio-Generics Era
• Worldwide sales of all biologic drugs, including therapeutic proteins, vaccines, and mAbs,
  reached ~$130 billion (2009 IMS)

• Evolving pharma landscape: Gradual strengthening of the biologic drug portfolio in
  preparation of the patent cliff as well as improving the profitability

• We predict a shift towards more R&D and higher valued M&A in biologics over the next
  few years, as the regulatory pathway for approvals of “Me Toos, Biosimilars” including
  mAbs comes into effect

• Potential market for biosimilars: >$30b in the second half of the decade as multiple
  patents expire

• Affordability to accelerate the demand

• Over time, we expect Affordable Biosimilars to take a significant market share and/or force
  Innovators to cut prices significantly



                                                                                                12
Maturing Technology Platforms For Better Biologics
• Second Generation Monoclonal Antibodies

• Antibody Drug conjugation (ADC)

• Protein Engineering: Humaneering, Glyco-engineering, Half-Life Extension
  technologies etc.




                                                                             13
Regulatory Pathway For Biogenerics
            EU and USA




                                     14
Global Pharmaceuticals – 2011 Outlook



Opportunities - Emerging Markets and Innovation -    Taking longer to
                            deliver

   Challenges - Patent Expiry and Regulatory pressures - Imminent

         Global Pharma’s Cutting Cost to Manage the Gap




                                                                        15
Highlights for 2011 – Global Pharma’s Nearing the Patent
                            Cliff
     Global pharmaceuticals – Emerging Market Strategy

     Outcome from Major Clinical Studies/Events expected to reshape Competitive
     Dynamics across several therapy classes

     New Drug Approvals for 2011 and their potential

     Healthcare Reforms

     How will patent expiry impact margins for Global Pharma companies




                                                                                  16
Global Pharma - Emerging Market Strategy

Who is doing it’s best in Emerging Markets?

Who will emerge eventually in Emerging Markets?

Pricing Mantra – Who has got it Right?

Branded Generics Strategy – Will it Deliver?

China – Growing Prominence

Notable Launches from Global Giants




                                                  17
Outcome from Major Clinical Studies/Events expected to reshape
     Competitive Dynamics across several therapy classes


Dyslipidemia

Stroke Prevention in Atrial Fibrillation

Acute Coronary Syndrome

Hypertension

Diabetes

Metastatic Melanoma

Wet Age AMD




                                                             18
New Drug Approvals in 2011 and their Potential




                                                 19
Healthcare Reforms

• What will be the impact?

• Who shall be worst hit?

• Who is immune?




                                           20
Health Care Reform: Doughnut Hole Discounts –
                Impact on Therapy Class

   Share Of Part D Enrollees Who Reached Doughnut Hole And Catastrophic Coverage
                            % that reached gap but                                                   Companies likely to bear
                                                         % that reached       % of Part D enrollees
Therapy Class                  not catastrophic                                                     the brunt because of major
                                                      catastrophic coverage    who use the drug
                                   coverage                                                                  presence

For Alzheimer's                       49                       15                      4            Pfizer
Oral anti-diabetics                   41                       10                      12           Merck, Astrazeneca, BMY
Proton-pump inhibitors                40                       11                      18           Astrazeneca, JNJ

Antidepressants                       35                       10                      18           Lilly, Pfizer, Astrazeneca

Angiotensin receptor                                                                                Novartis, Sanofi,
                                      35                        7                      17
blockers                                                                                            Astrazeneca
Statins                               33                        6                      40           Astrazeneca
Osteoporosis drugs                    32                        7                      15           Roche, GSK, Novartis
ACE inhibitors                        30                        5                      28           Sanofi Aventis
Source: MP Advisors, Company reports, Georgetown University/ IMS health LRX database 2007




                                                                                                                                 21
Patent Exposure: Global Pharmaceuticals
             Cumulative 2008 WW                   WW Sales
               Sales of Products    Total WW       Expiry -
                                                                                                  2010-12 Cumulative   2013-14 Cumulative
Company       Expiring between     Pharma Sales   2010-14 as   2010   2011   2012   2013   2014
                                                                                                   Patent Exposure%     Patent Exposure%
                    2010-14            ($b)       % of 2008
                      ($b)                          Sales



LLY                  12.2              17.0          71.9      10.1   29.4    6.3   10.2   15.9          45.8                 26.1

NOVO                 4.0                6.2          63.9      20.6    0.0    0.0    0.0   43.3          20.6                 43.3

AZN                  17.8              31.6          56.3       8.9    9.9   18.7    2.3   16.5          37.5                 18.8

PFE/WYE              34.8              63.1          55.2       7.6   26.1   10.7    6.3    4.5          44.4                 10.8

BMY                  8.1               17.7          45.6       0.0   31.6    7.5    6.5    0.0          39.1                 6.5

SAN                  17.3              40.3          42.9      10.6   10.9   14.6    4.6    2.3          36.1                 6.9

JNJ                  9.7               24.6          39.6       0.0    6.4    0.0   14.7   18.4          6.4                  33.1

NOVN                 10.8              28.3          38.3       0.0    4.0   26.7    7.5    0.0          30.7                 7.5

MRK/SGP              13.0              38.1          34.1       9.3    0.0   15.1    2.3    7.5          24.4                 9.8

GSK                  10.5              36.7          28.7      21.7    0.0    6.7    0.3    0.0          28.4                 0.3

ABT                  3.6               16.7          21.5       0.0    8.0    0.0    0.0   13.8          8.0                  13.8

ROG                  2.3               36.0          6.4        0.0    3.5    3.2    0.0    0.0          6.7                  0.0


Total ($b)          144.12             356.2         40.4




      Source: MP Advisors, Company
      Reports


                                                                                                                                            22
Emerging Markets : Will Take Longer To Deliver
                                        Size Of Emerging And Developed Markets


                                        GDP ($b)
                                                       Per Capita   Population in
Country                 Mkt Size ($b)
                                                        Income $      million        Prescription drugs   Prescription spending as %
                                        (Nominal)                                   Spending per Capita      of Per capita income
                                                    DEVELOPING COUNTRIES
China                         15          4,327          3,241          1335                18                      0.55%
India                         5           1,206          1,026          1175                6                       0.57%
Russia                        5           1,676          11,887         141                 49                      0.41%
Brazil                        12          1,572          8,188          192                 44                      0.54%
Turkey                        9           729            10,268          71                124                      1.21%
South Africa                  9           276            5,633           49                 39                      0.70%
                                                    DEVELOPED COUNTRIES
US                          281.6        14,441          47,039         307                1141                     2.43%
Japan                        57.2         4,910          38,661         127                448                      1.16%
Germany                      34.4         3,673          44,793          82                756                      1.69%
UK                           22.6         2,680          43,934          61                311                      0.71%
France                       37.2         2,866          44,781          64                796                      1.78%
Canada                       16.6         1,499          45,424          33                1000                     2.20%
Source: MP Advisors, Company Reports




                                                                                                                                       23
Indian Pharma - Tomorrow’s
      Global Generics




                             24
Para IVs – The New India Advantage

                           Snapshot of Indian Cos. Para IV Challenges
                                            No. of Para IVs where 30                   No. of products
                                No. of Para                               No. of FTF
             Indian cos.                    mths stay will expire in 12                settled / won /
                                    IVs                                    claimed
                                                      mths                               unlitigated
             Sun Pharma              19                13                     6                3
             Dr Reddy's              17                16                     5                6
             Lupin                   14                 5                     4                3
             Ranbaxy                 13                13                     8                5
             Wockhardt                8                 5                     3              Nil
             Glenmark                 6                 3                     3                2
             Aurobindo                5                 3                     2              Nil
             Torrent                  5                 4                     1                3
             Orchid                   4                 3                    Nil               2
             Cadila                   3                 2                    Nil             Nil

             Source: MP Advisors, Company Reports




Indian Pharma companies are involved in 50% of the ongoing Para IV litigations!



                                                                                                         25
Para IVs – The New India Advantage

                 Rank    Drug Name      Innovator       Sales '08 $m   Cos. as FTFs

                   1     Lipitor        Pfizer             12401          Ranbaxy
                   2     Plavix         Bristol Myers       9004          Apotex
                   6     Diovan         Novartis            5740          Ranbaxy
                   8     Nexium         AstraZeneca         5200          Ranbaxy

                   10    Zyprexa        Eli-Lilly          4697         Dr Reddy’s
                   15    Seroquel       AstraZeneca        4452            Teva
                   16    Singulair      Merck              4336            Teva
                   17    Actos          Takeda             3958          Ranbaxy
                   18    Effexor XR     Wyeth              3928            Teva

                                                                       Sandoz / Teva /
                   19    Atacand        AstraZeneca        3702            Mylan

                   20    Gleevec/Glivec Novartis           3670         Sun Pharma

                Source: MP Advisors


Indian cos. have 180-day exclusivity in 6 of the top 11 products under litigation


                                                                                         26
Domestic Formulations – Growth Guaranteed
                 20


                 16                 → GMP guidelines in July '05
                                                                               8
                                    → Excise duty on MRP in Jan. '05                                        8
                 12

                                                                                     1        8      7
                                                                                                            1
                 8
             %


                                                                                                     1
                          10          9            9              8            9         1
                 4                                                                                          9

                                                                                              4      5
                                           0               0
                 0                                                1
                          (1)
                                     (3)          (2)
                         (1)
                                     (1)
                 -4

                        8%          5%          7%               9%           18%            13%    13%    17%
                 -8
                         2002       2003         2004            2005         2006           2007   2008   2009


                                                        Volume        Value   New Products

                      Source: IMS




GMP norms earlier and GLP norms now to help consolidation of a highly fragmented
                                  market

                                                                                                                  27
Contract Manufacturing – Generics Gain The Most

Why manufacturing alliances happen only with generic cos. and not with contract
  manufacturer?

•    Generic cos. are present in various manufacturing technologies with competitive cost efficiencies as against a
     contract manufacturer that is limited to a handful of technologies.

•    Generic cos. are anyways selling the manufactured product to one or the other generic market and thus have well
     oiled manufacturing operations. As against this, a contract manufacturer will have to go through a lengthy validation
     procedure.

•    For a generic company, most of the time, contract manufacturing would be a way to leverage spare capacity and thus
     can offer much more competitive pricing as against a contract manufacturer that has to recover entire overheads
     from the contract manufacturing deal.

•    Most of the facilities of generic manufacturers are already validated by regulated market’s authorities – something
     that is not so easily found with a pure play contract manufacturer.


                        Gain For Generics is Loss for Contract Manufacturer


                                                                                                                             28
Acquisitions – Can One More Big One Happen?


Why are Global companies interested in Indian Pharma?

• Manufacturing cost efficiency

• Chemistry skills

• Growing India pharma market

• Indian cos. presence in critical emerging markets like Russia, Africa.




                                                                           29
Japan Pharma 2011
                日本の製薬会社
        Top Picks : Daiichi Sankyo, Takeda, Shionogi
                          and Torii




!
                                                       30
!   !
Summary
•   In 2009 and 2010, our thesis for Japan Pharma Inc was based on drive to reduce healthcare
    cost in Japan thru government lead incentives for genericization.

•   The Generics thesis has played out for now and spotlight for next 18 months will be on the
    clinical & regulatory outcome from Innovators.

•   Hybrid Pharma will start from 2011. We believe that the new business model will start
    showing its tangible and significant numbers from FY/12. Daiichi Sankyo is the only company
    in Japan in Hybrid Pharma.

•   Consolidation in Japan Generic may Start: Foreign/ non-generic companies have started
    taking Japan generic as one of the growth drivers.

•   Early Stage Pipeline of Japanese Companies shows that cancer is priority: Japanese majors
    have focused on acquiring companies or in-licensing compounds in Onco therapy. Takeda,
    Astellas, Daiichi-Sankyo, Eisai, Chugai and Kyowa Hakko Kirin – each of them possess decent
    number of cancer compounds.

•   Japanese Companies have Lost Their ‘Cash Rich’ Status: Except Takeda and Chugai, none of
    the Japanese companies carry >20% of their market-value in form of cash.


         2011-12, Innovation milestones will drive the valuation of stocks

                                                                                                  31
Segments Specific ‘Key Success Factors’
Segment                          Key Success Factors                                                                     Top Picks
Innovators
Domestic focused                 Low % sale coming from long listed products
                                 Late stage R&D – own as well as in-licensed.
                                                                                                                              Torii
                                 Internationalization capabilities
                                 Willingness to consolidate
                                 Strong marketing abilities in Japan such that it improves the chances of licensing-in
                                 good products

Global                           Higher overseas exposure
                                 Lower long listed drugs contribution                                                    Daiichi Sankyo,
                                                                                                                         Takeda, Shionogi
                                 Rich PhIII pipeline
Generics
           GP1/DP2               Strong marketing infrastructure with sales force and rapport with GP / DP
                                 Oral formulations etc.
    DPC3                         Distribution capabilities
                                 Injectable facilities, availability of all strengths of drug



                                 Cost effectiveness, stable supply
 1. General Practitioner; 2. Dispensing Pharmacy; 3. Diagnostic Procedure Combination



                                    JP Specific Drivers Continue To determine Success
                                                                                                                                            32
Large Pharma – Rich Pipeline
                      PhI    PhII      PhIII
                     candiid candid    candid
Company              ates    ates      ates   Major Focus     Comments
Takeda                 19       9        13   Cancer          Novel, varied targets for cancer
                                              Cancer &        R&D portfolio w ith some novel first in class targets,
Astellas               20       15       8
                                              metabolic       like survivin suppressant, GPR119 agonist
                                              Neurology &     Antibody against folate receptor alpha, taregting
Eisai                  0        10       7
                                              cancer          cancer, can be a useful anticancer agent
                                              Diabetes,
                                              Neurology,
Mitsubishi Tanabe      11       10       5                    Good novel targets in different therapeutic class
                                              Cardio &
                                              immunology
                                              Cancer &
                                                              R&D porfolio consisting of antibodies for cancer, w ith
Daiichi Sankyo         7        10       5    infectious
                                                              some good target like PPARY
                                              diseases
                                              Metabolic &
                                                              Neuropeptide Y Y5 receptor, a very attractive target
Shionogi               8        9        4    infectious
                                                              for obesity, but success rate low
                                              diseases
                                                              Has tw o first in class targets, Chemokine receptor 4
Kyow a Hakko Kirin     13       6        2    Cancer
                                                              antagonist & A33 for cancer
                                                              Novel validated targets for cancer, w orking on
Chugai                 9        10       1    Cancer
                                                              Raf/MEK pathw ay
                                              Diabetes &
                                                              First in class targets like TLR7 & PPARα/Y can be
Dainippon Sumitom      7        4        0    immunological
                                                              attractive
                                              disorders
Source: MP Advisors; Company Reports


                           Japanese Companies show that cancer is a priority
                                                                                                                        33
Cost Cutting : Japan vs. Other Sectors

                             GPM       SG&A        R&D      OP M     NP M
                         % of Sales (% of Sales) % of sales of Sales of Sales
                                                          %        %
Takeda                      80.02      31.50       19.95    28.57     18.96
Astellas                    70.17      33.48       21.55    15.13     9.83
Daiichi Sankyo              70.84      39.13       20.17    11.53     5.55
Eisai                       78.73      46.42       21.73    10.58     5.50
Mitsubishi Tanabe           63.66      28.21       20.76    15.47     7.75
Kyorin                      62.50      37.17       11.92    13.41     8.92
Dainippon Sumitomo          67.33      40.41       17.84    9.08      5.19
Kyowa Hakko                 43.47      23.09       10.43    9.95      5.44
Shionogi                    73.29      34.84       18.61    19.84     12.72
JAPAN AVG                   67.78      34.92      18.11     14.84     8.87
US Global                   77.44      28.16      18.77     30.09     22.84
EU Global                   74.65      30.90      17.03     31.99     22.01
M. Biotech                  82.15      22.21      17.65     40.92     33.52
India                       60.59      25.41       4.91     21.78     19.72


Diff vs. US-Global         -12.48%     24.01%     -3.53%   -50.69%   -61.14%
Diff vs. EU Global         -9.21%      13.01%     6.30%    -53.61%   -59.68%
Diff vs. M. Biotech         -17%        57%         3%      -64%      -74%
Diff vs. Indian              12%        37%        269%     -32%      -55%
*Average of three y ears (2010-2012)


Source: MP Advisors; Company Reports

               Low Margin Business = Better Room for Improvement

                                                                                34
‘Sum of Parts’ Relative Standing


                                            R&D
                   NPV of     Net Cash &                 NPV
                                          Expense                 Market
                 Mktd Prod marketable                  Pipeline             (1+2)/4 (1+2+3)/4
                                         (FY 03/11 -              Cap (4)
                      (1)      secu. (2)                  (3)
                                             16)
Global Innovator Pharma
Takeda              1580.4        897.0    1153.1       389.1     3070.6     81%      93%
Astellas             699.8        176.2     933.9       160.9     1419.4     62%      73%
Shionogi             291.8         15.4     233.8        63.2      516.4     59%      72%
Daiichi Sankyo       591.5         68.7     922.8       191.3     1289.7     51%      66%
Eisai                377.4       -145.7    601.2        137.3      816.9     28%      45%
Domestic Innovator Pharma
Kyorin               55.8          14.0      63.8        6.8       101.7     69%      75%
Chugai               315.6        173.1     273.6        73.9      819.9     60%      69%
Dainippon Sum        240.7        -79.0     286.3        35.3      291.1     56%      68%
Mitsubishi tana      289.0         70.9     394.7       129.8      738.8     49%      66%
Kyowa Hakko          190.8         33.4     135.0        46.0      488.3     46%      55%
Source: MP Advisors; Company reports




             Good Opportunities Exists Even if Uncertainties Turn Negative

                                                                                                35
Cash Position of Japanese Pharma Cos

                                                                          Net
                                       Marketed     Total      Total                      Net Cash
                           Cash                                          cash
     Company                           Securitie    Cash    Liabilities          M Cap    as % of
                            (1)                                         (1+2)-
                                        s (2)      (1+2)        (3)                        M Cap
                                                                           3
Takeda                     280.5        616.5      897.0       0.0      897.0    3074.6    29.2%
Chugai                     120.9         52.2      173.1       0.0      173.1    819.9     21.1%
Kyorin                      16.0         5.0        21.0       6.2       14.8    101.7     14.5%
Astellas                   184.0         22.2      206.2      30.0      176.2    1419.4    12.4%
Mitsubishi tanabe           29.2        77.6       106.9      36.0       70.9    738.8      9.6%
Kyowa Hakko                  NA           NA        46.7       13.3      33.4     488.3     6.8%
Daiichi Sankyo             101.1        281.5      362.3      293.6      68.7    1289.7     5.3%
Shionogi                    42.3        72.1       114.4      99.0       15.4    516.4      3.0%
Eisai                      116.1         88.0      204.1      349.8    -145.7     816.9      NA
D Sumitomo                  14.7        74.4        89.1      168.2     -79.0    291.3       NA
Source: MP Advisors; Company Reports




            Japanese Companies have Lost Their ‘Cash Rich’ Status


                                                                                                     36
Domestic Cos Confronting Several Fronts
                            Mar-07    Mar-08    Mar-09 Mar-10     Mar-11    Mar-12    Mar-13 Mar-14 Mar-15 Mar-16                  Company
Long L As % of DO Sales       43.51     38.61     38.39   34.63     48.14     50.16     50.21   46.17   43.61   38.35
                                                                                                                                   Astellas
Overseas Sales %              46.77     45.77     43.49   42.08     40.02     42.89     44.15   46.30   48.29   51.21
Long L As % of DO Sales      32.12     26.80     18.51    21.82    19.44     23.17     26.82    19.66   18.12   16.65
                                                                                                                                    Chugai
Overseas Sales %              9.72      9.70      6.25     7.05     8.00      9.41      9.51     9.54    9.27    9.36
Long L As % of DO Sales                28.98     31.81    47.26    56.14     52.37     48.59    45.79   44.46   43.43
                                                                                                                             Daiichi Sankyo
Overseas Sales %                        38.6      44.7     50.4     50.9      52.0      54.8     54.2    57.5    58.0
Long L As % of DO Sales       16.68     41.04     71.73   70.01     67.55     61.51     57.91   59.96   55.51   51.37
                                                                                                                        Dainippon Sumitomo
Overseas Sales %               7.31      7.99      7.27   17.80     36.41     34.62     35.18   32.09   30.15   25.26
Long L As % of DO Sales      28.02     26.21     28.69    27.95    45.27     78.57     75.68    74.64   71.40   62.18
                                                                                                                                      Eisai
Overseas Sales %             57.30     58.53     64.26    61.58    59.42     55.99     58.49    58.00   60.03   65.13
Long L As % of DO Sales      41.40     39.32     32.81    29.71    28.07     27.14     25.63    24.32   23.09   21.91
                                                                                                                                     Kyorin
Overseas Sales %              4.15      3.70      2.75     2.36     2.12      1.93      1.78     1.74    1.61    1.49
Long L As % of DO Sales       23.72     21.15     23.86   34.96     33.04     31.33     32.16   36.53   34.89   33.32
                                                                                                                         Kyowa Hakko Kirin
Overseas Sales %               3.44      4.16      6.69    4.89      5.16      5.05      5.00    5.04    5.08    5.11
Long L As % of DO Sales       65.11     60.68     60.93   59.41     61.62     57.29     52.71   49.21   59.85   57.77
                                                                                                                          Mitsubishi Tanabe
Overseas Sales %               5.81      6.10      5.65    5.20      4.94      4.73      4.46    4.18    3.95    3.83
Long L As % of DO Sales      44.85     39.67     49.65    42.22    37.66     32.24     26.95    22.17   18.37   15.74
                                                                                                                                  Shionogi
Overseas Sales %             14.44     15.81     24.65    36.33    38.50     39.18     40.05    39.28   39.08   38.26
Long L As % of DO Sales       14.93     19.31     19.51   23.00     28.91     27.97     27.37   45.31   44.43   43.64
                                                                                                                                    Takeda
Overseas Sales %              33.82     49.69     54.80   53.16     50.51     52.38     45.27   46.43   47.23   49.68
Source: MP Advisors; Company Reports

                          High Dependence on Domestic Markets + Long Listed Products
                                 Makes Do. Cos Vulnerable to Healthcare Reforms
                                                                                                                                              37
Revised Incentives For Pharmacies and GE Usage Rate

                                                                                   Rate of GE (%)                            Rate of GE (%)
                                                                            (on prescription basis)
                                                                                                           GE usage rate    (o n volume basis)
                                                                                                                           Relative   Cumulative
                                                                        Relative number Cumulative Total
                         Until March, 2010       Since April, 2010                                                         number        Total
      Standard for                                                           9.7                9.7           65%≦           0.1          0.2
       calculation      on prescription basis   Incentive points (¥)         4.3                    14      60%≦ 65%         0.2          0.4
                                                                             5.5                19.6        55%≦ 60%         0.3          0.7
GE drug        30%≦    4 points   + 13 points   17 points (170yen)
                                                                             7.4                    27      50%≦ 55%         0.5          1.2
usage rate     25%≦    0 points   +13 points    13 points (130 yen)          9.9                36.9        45%≦ 50%         1.0          2.2
               20%≦    0 points   +6 points      6 points (60 yen)           13.3               50.3        40%≦ 45%         1.5          3.7
               20%>    0 points    ±0 points         0 points                16.5               66.7        35%≦ 40%         2.4           6
                                                                             15.3                   82      30%≦ 35%         4.0          10.1
Source: MP Advisors; Company Reports
                                                                             8.1                90.1        25%≦ 30%         7.3          17.4
                                                                             5.1                95.2        20%≦ 25%        13.3          30.6
                                                                             2.6                97.8        15%≦ 20%        25.5          56.1
                                                                             1.3                99.1        10%≦ 15%        30.7          86.8
                                                                             0.6                99.7         5%≦ 10%        11.5          98.3
                                                                             0.3                100          0%≦ 5%          1.7          100
                                                                                       42.6                Average rate            18.2
                                                                                       40.1                Median rate             16.0


  Generics Investment Thesis:

  •    Increase in incentives for pharmacies has led to a spur in generic sales (~50% increase in 1Q FY 03/11)

  •    Growth will not continue as number of pharmacies (~82% of total) have now reached the ‘bracket’ that gets the maximum benefit of
       ‘Rx incentive for generics


               Incentives for Pharmacies are playing out their maximum impact                                                                      38
Generic Cos at a Glance
                                       Sawai                            Towa                          Nippon Chemi
                         03/10   03/11 03/12 03/13 03/14    03/10 03/11 03/12 03/1   03/14   03/10   03/11 03/12 03/13   03/14
                 ¥b        A        E    E     E     E        A     E      E   3E      E       A       E     E     E       E
           Sales          50.1    61.6  72.3 82.6   90.5     39.0  44.2 49.5 56.2     63.0    24.0    28.6  30.9  33.7    36.1
           % Change YoY 13.1     23.0 17.4 14.3     9.5      8.7  13.2 12.1 13.4     12.2     7.5    19.3   7.9   9.1     7.1
            COGS          26.3    32.6  38.3 44.2   48.2     18.8  21.3 23.7 26.8     30.0    11.4    14.7  15.8  17.3    18.6
            SG&A          11.7    12.8  15.2 17.5   19.1     9.9   11.0 12.3 14.2     16.0    11.8    12.8  13.7  15.0    15.9
              % of sales 23.3    20.8 21.0 21.2 21.1        25.5 25.0 24.8 25.3      25.3    47.8    44.8   44.3  44.6   44.1
            R&D           3.6      4.2  5.0   5.6    6.4     2.6   3.1    3.4  4.0    4.5
              % of sales  7.2     6.8   6.9   6.8   7.1      6.6   7.1   7.0 7.1      7.2
           OP             8.5     12.0  13.8 15.3   16.8     7.8   8.8   10.1 11.2    12.5   0.8     1.1    1.4   1.4    1.6
           % Margin      17.0    19.4 19.2 18.6 18.6        19.9 19.8 20.4 19.9      19.9    3.2     3.9    4.6   4.0    4.5
           NP             5.0      6.6  8.2   9.1   10.0     4.6   5.3    6.1  6.5    7.3    0.3     0.5    0.7   0.7    0.9
           % Margin      10.0    10.7 11.4 11.0 11.0        11.8 12.0 12.3 11.5      11.5    1.1     1.9    2.4   2.1    2.4
      Source: MP Advisors; Company Reports

Generics Investment Thesis:

•   Broadly generic market is divided into two segments: GP/Dispensing market and DPC market
•   Companies focusing on the GP/Dispensing market: Companies ability to offer better margins remains the key success factor. Growth in
    dispensing Pharma market due to increase in incentive of pharmacies. Companies like Towa and Sawai focus on these segments.
•   Companies focusing on the DPC market : Number of DPC hospitals are >1500 and likely to grow further. Stable supply, availability of
    formulations at different strengths, and a strong distribution channel with wholesalers are key growth drivers. Companies like Nippon
    Chemiphar, Eisai’s and Kyorin’s generic divisions etc. focus on this segment.
•   We expect generics penetration to reach ~8% (by value) by 2012 (Government’s target is 15%. The new patent expiries of ~900b yen in
    next three years will help generic companies maintain current pace of growth.


                                                                                                                                            39
Thank You




            40

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Outlook 2011 presentation

  • 1. Global Bio-Pharmaceutical OUTLOOK 2011 ! ! B/203, Alkapuri Arcade, R.C.Dutt Road, Vadodara-390007, INDIA. Phone: +1|212| 343-6096, +91|265| 232-7096, E-mail: mp@mpadvisor.com !
  • 2. Rising Star What is Going Right For the sector? What Are the Challenges? Is investment in innovative therapeutics warranted? Which innovative therapeutics has or will make an impact on the quality of our lives in the next two to three years? What therapy areas present investment opportunities? What events in the sector will win thumbs down or be an outright –ve? Value creation: Our portfolio and top pick recommendations
  • 3. What Is Going “Right”? • Moving beyond the “wait and watch” for Proof-of-Concept (PoC), Big pharma are giving importance to Proof-of-Relevance *-Paradigm shift in Partnering Deals: Tap Them Young • While the HC Reform bill served a blow to profitable Pharma and Biotech companies in US, it has boosted the Spirit of Research for the non-profitable biotech/ biopharma companies, Rising stars (RS). R&D may turn the corner as Obama has increased the R&D tax credit by 20% and made it permanent.. • Drug approval in 09 and 2010 was not depressing and some novel approaches have made it to the market- Provenge (Prostate cancer vaccine) Prolia (PM, osteoporosis), Gileniya (oral MS drug). The report discusses important upcoming regulatory and clinical milestones *Proof-of-Relevance: To identify the indisputable clinical and commercial value of early stages compounds.
  • 4. What Are the Challenges? • Regulatory Pathway and Reimbursements- Our Focused Sector Report discusses these in depth • Biosimilars and Patent Expiry- How Close and Real is the “Bio-generic Era”? • Safety continues to be the key factor in approval of drugs • Will Lupus, Obesity, Melanoma etc, See a New Drug?- Analysis and Our Take on the Outcome of the regulatory events. • Binary Events- Another Intermune like Debacle in 2011? Select milestones in 2011 which could make or break a Company are included in the Report.
  • 5. Therapy Areas Offering Investment Opportunities • HCV- Protease Inhibitors to The Rescue - Will sweep the HCV market, as they did in the case of AIDS. At least two compounds will be approved (telaprevir, boceprevir) before 2012. Analysis of the therapy Area and Leading Companies- Vertex, Pharmasset. Market Dynamics and unmet Need. • Autoimmune/ Inflammation diseases have seen the best outcome –both in targeting unmet needs and better patient friendly treatment options. Oral drug (INCB28050, R788, RDEA594, Gilenya) options are likely to make way for many diseases, such as, RA, MS; where injectables and biologics are the only options. Lupus and Gout will finally see approval of safer and more efficacious products (RDEA594, Benlysta, Epratuzumab) by 2011-14. • Rare Genetic - Orphan diseases continue to be pursued as a preferred area by Innovators - premium pricing, low regulatory bar, etc. are incentives. Besides ERT (Enzyme Replacement Therapy), drugs for MPN (Myeloproliferative Neoplasms), IPF, HoFH (Homozygous Hypercholesterolemia) should be approved by 2011-14. • Melanoma – MAbs may finally deliver –With 120,000 diagnosis of melanoma annually, and 300 agents investigated thus far, it is amazing that effective products for melanoma remain elusive. Benlysta Approval???
  • 6. Mature Biotech Resembling Global Pharmas and Specialty Pharmas of last decade “Is the age of the biotech monopoly about to end ?”
  • 7. Mature Biotech – Issues CY 2010 affected all Pharma companies by “Obamanisation and Implementation of the Health Care Reforms (HC)” wiping off their market value significantly in the first half of 2010. • Drying new product launches, thin pipeline and intensifying competition • New Drugs Approved, but will they boost the sales or is the wait going to be longer? • Patent Expiry Impact is Modest and Built into the Current Price; However outcome of Para IV Filing from Global Generic Players can surprise and will remain a “Hanging Sword” for the innovator. Report includes the patent expiry, sales table of major biologics and regulatory pathway being framed in US and for mAB in EU. • Life cycle management approach by making better biologics, me toos. Report highlights the 2nd generation tools and technologies for making better biologics, mAB based drugs. •
  • 8. Mature Biotech – Issues • Discounted pricing for patented follow-on drug launches could become a norm • Re-imbursement issues: • CMS support to MCOs and PBMs for price negotiations should limit pricing flexibility • Off label re-imbursement cuts • German/ EU reference pricing, NICE & Japanese health reforms seeking stringent cost control • FOB or Biosimilars: • Coming closer to reality as guidelines already placed in EU and in the works in US. • Lack of products to make up for the biosimilar erosion and sales loss. • M&A and In-licensing remains key for future growth • Compete with cash rich Global Pharmas • Fewer opportunities with inflated valuation
  • 9. Silver Lining • Mature Biotech Can still afford to choose good products in the making… • Outsourcing is the Mantra for Fueling the Pipeline • Healthy cash position and depressed valuations = opportunity to buy back shares and improve valuations.
  • 10. Valuation Methodology • MP Advisors’ Proprietary Sum-of-The-Parts Valuation enables us to quantify the difference between the current equity value and the value arrived using our valuation method comprising three parts, i.e., Part A, Part B, and Part C as described below: • Value the marketed products till their respective patent expiries (Part A); • Value the late stage pipeline as of today (Part B) (Consider only the late stage PhIII and registered products). • Value the management’s ability to convert early stage R&D activities into mainstream products and company’s strategic approach- historical and visionary, by giving a premium to their future cumulative R&D investment (Part C). • The difference between the current equity value and Part A plus cash and other income value represents the gap that needs to be met through the company’s late stage R&D pipeline (Part B) and other strategic efforts (Part C) and drives our recommendations
  • 11. 3Bs: Biologics, Bio-Generics, and Better-biologics: A Value Proposition
  • 12. Dawn of the Biologics/Bio-Generics Era • Worldwide sales of all biologic drugs, including therapeutic proteins, vaccines, and mAbs, reached ~$130 billion (2009 IMS) • Evolving pharma landscape: Gradual strengthening of the biologic drug portfolio in preparation of the patent cliff as well as improving the profitability • We predict a shift towards more R&D and higher valued M&A in biologics over the next few years, as the regulatory pathway for approvals of “Me Toos, Biosimilars” including mAbs comes into effect • Potential market for biosimilars: >$30b in the second half of the decade as multiple patents expire • Affordability to accelerate the demand • Over time, we expect Affordable Biosimilars to take a significant market share and/or force Innovators to cut prices significantly 12
  • 13. Maturing Technology Platforms For Better Biologics • Second Generation Monoclonal Antibodies • Antibody Drug conjugation (ADC) • Protein Engineering: Humaneering, Glyco-engineering, Half-Life Extension technologies etc. 13
  • 14. Regulatory Pathway For Biogenerics EU and USA 14
  • 15. Global Pharmaceuticals – 2011 Outlook Opportunities - Emerging Markets and Innovation - Taking longer to deliver Challenges - Patent Expiry and Regulatory pressures - Imminent Global Pharma’s Cutting Cost to Manage the Gap 15
  • 16. Highlights for 2011 – Global Pharma’s Nearing the Patent Cliff Global pharmaceuticals – Emerging Market Strategy Outcome from Major Clinical Studies/Events expected to reshape Competitive Dynamics across several therapy classes New Drug Approvals for 2011 and their potential Healthcare Reforms How will patent expiry impact margins for Global Pharma companies 16
  • 17. Global Pharma - Emerging Market Strategy Who is doing it’s best in Emerging Markets? Who will emerge eventually in Emerging Markets? Pricing Mantra – Who has got it Right? Branded Generics Strategy – Will it Deliver? China – Growing Prominence Notable Launches from Global Giants 17
  • 18. Outcome from Major Clinical Studies/Events expected to reshape Competitive Dynamics across several therapy classes Dyslipidemia Stroke Prevention in Atrial Fibrillation Acute Coronary Syndrome Hypertension Diabetes Metastatic Melanoma Wet Age AMD 18
  • 19. New Drug Approvals in 2011 and their Potential 19
  • 20. Healthcare Reforms • What will be the impact? • Who shall be worst hit? • Who is immune? 20
  • 21. Health Care Reform: Doughnut Hole Discounts – Impact on Therapy Class Share Of Part D Enrollees Who Reached Doughnut Hole And Catastrophic Coverage % that reached gap but Companies likely to bear % that reached % of Part D enrollees Therapy Class not catastrophic the brunt because of major catastrophic coverage who use the drug coverage presence For Alzheimer's 49 15 4 Pfizer Oral anti-diabetics 41 10 12 Merck, Astrazeneca, BMY Proton-pump inhibitors 40 11 18 Astrazeneca, JNJ Antidepressants 35 10 18 Lilly, Pfizer, Astrazeneca Angiotensin receptor Novartis, Sanofi, 35 7 17 blockers Astrazeneca Statins 33 6 40 Astrazeneca Osteoporosis drugs 32 7 15 Roche, GSK, Novartis ACE inhibitors 30 5 28 Sanofi Aventis Source: MP Advisors, Company reports, Georgetown University/ IMS health LRX database 2007 21
  • 22. Patent Exposure: Global Pharmaceuticals Cumulative 2008 WW WW Sales Sales of Products Total WW Expiry - 2010-12 Cumulative 2013-14 Cumulative Company Expiring between Pharma Sales 2010-14 as 2010 2011 2012 2013 2014 Patent Exposure% Patent Exposure% 2010-14 ($b) % of 2008 ($b) Sales LLY 12.2 17.0 71.9 10.1 29.4 6.3 10.2 15.9 45.8 26.1 NOVO 4.0 6.2 63.9 20.6 0.0 0.0 0.0 43.3 20.6 43.3 AZN 17.8 31.6 56.3 8.9 9.9 18.7 2.3 16.5 37.5 18.8 PFE/WYE 34.8 63.1 55.2 7.6 26.1 10.7 6.3 4.5 44.4 10.8 BMY 8.1 17.7 45.6 0.0 31.6 7.5 6.5 0.0 39.1 6.5 SAN 17.3 40.3 42.9 10.6 10.9 14.6 4.6 2.3 36.1 6.9 JNJ 9.7 24.6 39.6 0.0 6.4 0.0 14.7 18.4 6.4 33.1 NOVN 10.8 28.3 38.3 0.0 4.0 26.7 7.5 0.0 30.7 7.5 MRK/SGP 13.0 38.1 34.1 9.3 0.0 15.1 2.3 7.5 24.4 9.8 GSK 10.5 36.7 28.7 21.7 0.0 6.7 0.3 0.0 28.4 0.3 ABT 3.6 16.7 21.5 0.0 8.0 0.0 0.0 13.8 8.0 13.8 ROG 2.3 36.0 6.4 0.0 3.5 3.2 0.0 0.0 6.7 0.0 Total ($b) 144.12 356.2 40.4 Source: MP Advisors, Company Reports 22
  • 23. Emerging Markets : Will Take Longer To Deliver Size Of Emerging And Developed Markets GDP ($b) Per Capita Population in Country Mkt Size ($b) Income $ million Prescription drugs Prescription spending as % (Nominal) Spending per Capita of Per capita income DEVELOPING COUNTRIES China 15 4,327 3,241 1335 18 0.55% India 5 1,206 1,026 1175 6 0.57% Russia 5 1,676 11,887 141 49 0.41% Brazil 12 1,572 8,188 192 44 0.54% Turkey 9 729 10,268 71 124 1.21% South Africa 9 276 5,633 49 39 0.70% DEVELOPED COUNTRIES US 281.6 14,441 47,039 307 1141 2.43% Japan 57.2 4,910 38,661 127 448 1.16% Germany 34.4 3,673 44,793 82 756 1.69% UK 22.6 2,680 43,934 61 311 0.71% France 37.2 2,866 44,781 64 796 1.78% Canada 16.6 1,499 45,424 33 1000 2.20% Source: MP Advisors, Company Reports 23
  • 24. Indian Pharma - Tomorrow’s Global Generics 24
  • 25. Para IVs – The New India Advantage Snapshot of Indian Cos. Para IV Challenges No. of Para IVs where 30 No. of products No. of Para No. of FTF Indian cos. mths stay will expire in 12 settled / won / IVs claimed mths unlitigated Sun Pharma 19 13 6 3 Dr Reddy's 17 16 5 6 Lupin 14 5 4 3 Ranbaxy 13 13 8 5 Wockhardt 8 5 3 Nil Glenmark 6 3 3 2 Aurobindo 5 3 2 Nil Torrent 5 4 1 3 Orchid 4 3 Nil 2 Cadila 3 2 Nil Nil Source: MP Advisors, Company Reports Indian Pharma companies are involved in 50% of the ongoing Para IV litigations! 25
  • 26. Para IVs – The New India Advantage Rank Drug Name Innovator Sales '08 $m Cos. as FTFs 1 Lipitor Pfizer 12401 Ranbaxy 2 Plavix Bristol Myers 9004 Apotex 6 Diovan Novartis 5740 Ranbaxy 8 Nexium AstraZeneca 5200 Ranbaxy 10 Zyprexa Eli-Lilly 4697 Dr Reddy’s 15 Seroquel AstraZeneca 4452 Teva 16 Singulair Merck 4336 Teva 17 Actos Takeda 3958 Ranbaxy 18 Effexor XR Wyeth 3928 Teva Sandoz / Teva / 19 Atacand AstraZeneca 3702 Mylan 20 Gleevec/Glivec Novartis 3670 Sun Pharma Source: MP Advisors Indian cos. have 180-day exclusivity in 6 of the top 11 products under litigation 26
  • 27. Domestic Formulations – Growth Guaranteed 20 16 → GMP guidelines in July '05 8 → Excise duty on MRP in Jan. '05 8 12 1 8 7 1 8 % 1 10 9 9 8 9 1 4 9 4 5 0 0 0 1 (1) (3) (2) (1) (1) -4 8% 5% 7% 9% 18% 13% 13% 17% -8 2002 2003 2004 2005 2006 2007 2008 2009 Volume Value New Products Source: IMS GMP norms earlier and GLP norms now to help consolidation of a highly fragmented market 27
  • 28. Contract Manufacturing – Generics Gain The Most Why manufacturing alliances happen only with generic cos. and not with contract manufacturer? • Generic cos. are present in various manufacturing technologies with competitive cost efficiencies as against a contract manufacturer that is limited to a handful of technologies. • Generic cos. are anyways selling the manufactured product to one or the other generic market and thus have well oiled manufacturing operations. As against this, a contract manufacturer will have to go through a lengthy validation procedure. • For a generic company, most of the time, contract manufacturing would be a way to leverage spare capacity and thus can offer much more competitive pricing as against a contract manufacturer that has to recover entire overheads from the contract manufacturing deal. • Most of the facilities of generic manufacturers are already validated by regulated market’s authorities – something that is not so easily found with a pure play contract manufacturer. Gain For Generics is Loss for Contract Manufacturer 28
  • 29. Acquisitions – Can One More Big One Happen? Why are Global companies interested in Indian Pharma? • Manufacturing cost efficiency • Chemistry skills • Growing India pharma market • Indian cos. presence in critical emerging markets like Russia, Africa. 29
  • 30. Japan Pharma 2011 日本の製薬会社 Top Picks : Daiichi Sankyo, Takeda, Shionogi and Torii ! 30 ! !
  • 31. Summary • In 2009 and 2010, our thesis for Japan Pharma Inc was based on drive to reduce healthcare cost in Japan thru government lead incentives for genericization. • The Generics thesis has played out for now and spotlight for next 18 months will be on the clinical & regulatory outcome from Innovators. • Hybrid Pharma will start from 2011. We believe that the new business model will start showing its tangible and significant numbers from FY/12. Daiichi Sankyo is the only company in Japan in Hybrid Pharma. • Consolidation in Japan Generic may Start: Foreign/ non-generic companies have started taking Japan generic as one of the growth drivers. • Early Stage Pipeline of Japanese Companies shows that cancer is priority: Japanese majors have focused on acquiring companies or in-licensing compounds in Onco therapy. Takeda, Astellas, Daiichi-Sankyo, Eisai, Chugai and Kyowa Hakko Kirin – each of them possess decent number of cancer compounds. • Japanese Companies have Lost Their ‘Cash Rich’ Status: Except Takeda and Chugai, none of the Japanese companies carry >20% of their market-value in form of cash. 2011-12, Innovation milestones will drive the valuation of stocks 31
  • 32. Segments Specific ‘Key Success Factors’ Segment Key Success Factors Top Picks Innovators Domestic focused Low % sale coming from long listed products Late stage R&D – own as well as in-licensed. Torii Internationalization capabilities Willingness to consolidate Strong marketing abilities in Japan such that it improves the chances of licensing-in good products Global Higher overseas exposure Lower long listed drugs contribution Daiichi Sankyo, Takeda, Shionogi Rich PhIII pipeline Generics GP1/DP2 Strong marketing infrastructure with sales force and rapport with GP / DP Oral formulations etc. DPC3 Distribution capabilities Injectable facilities, availability of all strengths of drug Cost effectiveness, stable supply 1. General Practitioner; 2. Dispensing Pharmacy; 3. Diagnostic Procedure Combination JP Specific Drivers Continue To determine Success 32
  • 33. Large Pharma – Rich Pipeline PhI PhII PhIII candiid candid candid Company ates ates ates Major Focus Comments Takeda 19 9 13 Cancer Novel, varied targets for cancer Cancer & R&D portfolio w ith some novel first in class targets, Astellas 20 15 8 metabolic like survivin suppressant, GPR119 agonist Neurology & Antibody against folate receptor alpha, taregting Eisai 0 10 7 cancer cancer, can be a useful anticancer agent Diabetes, Neurology, Mitsubishi Tanabe 11 10 5 Good novel targets in different therapeutic class Cardio & immunology Cancer & R&D porfolio consisting of antibodies for cancer, w ith Daiichi Sankyo 7 10 5 infectious some good target like PPARY diseases Metabolic & Neuropeptide Y Y5 receptor, a very attractive target Shionogi 8 9 4 infectious for obesity, but success rate low diseases Has tw o first in class targets, Chemokine receptor 4 Kyow a Hakko Kirin 13 6 2 Cancer antagonist & A33 for cancer Novel validated targets for cancer, w orking on Chugai 9 10 1 Cancer Raf/MEK pathw ay Diabetes & First in class targets like TLR7 & PPARα/Y can be Dainippon Sumitom 7 4 0 immunological attractive disorders Source: MP Advisors; Company Reports Japanese Companies show that cancer is a priority 33
  • 34. Cost Cutting : Japan vs. Other Sectors GPM SG&A R&D OP M NP M % of Sales (% of Sales) % of sales of Sales of Sales % % Takeda 80.02 31.50 19.95 28.57 18.96 Astellas 70.17 33.48 21.55 15.13 9.83 Daiichi Sankyo 70.84 39.13 20.17 11.53 5.55 Eisai 78.73 46.42 21.73 10.58 5.50 Mitsubishi Tanabe 63.66 28.21 20.76 15.47 7.75 Kyorin 62.50 37.17 11.92 13.41 8.92 Dainippon Sumitomo 67.33 40.41 17.84 9.08 5.19 Kyowa Hakko 43.47 23.09 10.43 9.95 5.44 Shionogi 73.29 34.84 18.61 19.84 12.72 JAPAN AVG 67.78 34.92 18.11 14.84 8.87 US Global 77.44 28.16 18.77 30.09 22.84 EU Global 74.65 30.90 17.03 31.99 22.01 M. Biotech 82.15 22.21 17.65 40.92 33.52 India 60.59 25.41 4.91 21.78 19.72 Diff vs. US-Global -12.48% 24.01% -3.53% -50.69% -61.14% Diff vs. EU Global -9.21% 13.01% 6.30% -53.61% -59.68% Diff vs. M. Biotech -17% 57% 3% -64% -74% Diff vs. Indian 12% 37% 269% -32% -55% *Average of three y ears (2010-2012) Source: MP Advisors; Company Reports Low Margin Business = Better Room for Improvement 34
  • 35. ‘Sum of Parts’ Relative Standing R&D NPV of Net Cash & NPV Expense Market Mktd Prod marketable Pipeline (1+2)/4 (1+2+3)/4 (FY 03/11 - Cap (4) (1) secu. (2) (3) 16) Global Innovator Pharma Takeda 1580.4 897.0 1153.1 389.1 3070.6 81% 93% Astellas 699.8 176.2 933.9 160.9 1419.4 62% 73% Shionogi 291.8 15.4 233.8 63.2 516.4 59% 72% Daiichi Sankyo 591.5 68.7 922.8 191.3 1289.7 51% 66% Eisai 377.4 -145.7 601.2 137.3 816.9 28% 45% Domestic Innovator Pharma Kyorin 55.8 14.0 63.8 6.8 101.7 69% 75% Chugai 315.6 173.1 273.6 73.9 819.9 60% 69% Dainippon Sum 240.7 -79.0 286.3 35.3 291.1 56% 68% Mitsubishi tana 289.0 70.9 394.7 129.8 738.8 49% 66% Kyowa Hakko 190.8 33.4 135.0 46.0 488.3 46% 55% Source: MP Advisors; Company reports Good Opportunities Exists Even if Uncertainties Turn Negative 35
  • 36. Cash Position of Japanese Pharma Cos Net Marketed Total Total Net Cash Cash cash Company Securitie Cash Liabilities M Cap as % of (1) (1+2)- s (2) (1+2) (3) M Cap 3 Takeda 280.5 616.5 897.0 0.0 897.0 3074.6 29.2% Chugai 120.9 52.2 173.1 0.0 173.1 819.9 21.1% Kyorin 16.0 5.0 21.0 6.2 14.8 101.7 14.5% Astellas 184.0 22.2 206.2 30.0 176.2 1419.4 12.4% Mitsubishi tanabe 29.2 77.6 106.9 36.0 70.9 738.8 9.6% Kyowa Hakko NA NA 46.7 13.3 33.4 488.3 6.8% Daiichi Sankyo 101.1 281.5 362.3 293.6 68.7 1289.7 5.3% Shionogi 42.3 72.1 114.4 99.0 15.4 516.4 3.0% Eisai 116.1 88.0 204.1 349.8 -145.7 816.9 NA D Sumitomo 14.7 74.4 89.1 168.2 -79.0 291.3 NA Source: MP Advisors; Company Reports Japanese Companies have Lost Their ‘Cash Rich’ Status 36
  • 37. Domestic Cos Confronting Several Fronts Mar-07 Mar-08 Mar-09 Mar-10 Mar-11 Mar-12 Mar-13 Mar-14 Mar-15 Mar-16 Company Long L As % of DO Sales 43.51 38.61 38.39 34.63 48.14 50.16 50.21 46.17 43.61 38.35 Astellas Overseas Sales % 46.77 45.77 43.49 42.08 40.02 42.89 44.15 46.30 48.29 51.21 Long L As % of DO Sales 32.12 26.80 18.51 21.82 19.44 23.17 26.82 19.66 18.12 16.65 Chugai Overseas Sales % 9.72 9.70 6.25 7.05 8.00 9.41 9.51 9.54 9.27 9.36 Long L As % of DO Sales 28.98 31.81 47.26 56.14 52.37 48.59 45.79 44.46 43.43 Daiichi Sankyo Overseas Sales % 38.6 44.7 50.4 50.9 52.0 54.8 54.2 57.5 58.0 Long L As % of DO Sales 16.68 41.04 71.73 70.01 67.55 61.51 57.91 59.96 55.51 51.37 Dainippon Sumitomo Overseas Sales % 7.31 7.99 7.27 17.80 36.41 34.62 35.18 32.09 30.15 25.26 Long L As % of DO Sales 28.02 26.21 28.69 27.95 45.27 78.57 75.68 74.64 71.40 62.18 Eisai Overseas Sales % 57.30 58.53 64.26 61.58 59.42 55.99 58.49 58.00 60.03 65.13 Long L As % of DO Sales 41.40 39.32 32.81 29.71 28.07 27.14 25.63 24.32 23.09 21.91 Kyorin Overseas Sales % 4.15 3.70 2.75 2.36 2.12 1.93 1.78 1.74 1.61 1.49 Long L As % of DO Sales 23.72 21.15 23.86 34.96 33.04 31.33 32.16 36.53 34.89 33.32 Kyowa Hakko Kirin Overseas Sales % 3.44 4.16 6.69 4.89 5.16 5.05 5.00 5.04 5.08 5.11 Long L As % of DO Sales 65.11 60.68 60.93 59.41 61.62 57.29 52.71 49.21 59.85 57.77 Mitsubishi Tanabe Overseas Sales % 5.81 6.10 5.65 5.20 4.94 4.73 4.46 4.18 3.95 3.83 Long L As % of DO Sales 44.85 39.67 49.65 42.22 37.66 32.24 26.95 22.17 18.37 15.74 Shionogi Overseas Sales % 14.44 15.81 24.65 36.33 38.50 39.18 40.05 39.28 39.08 38.26 Long L As % of DO Sales 14.93 19.31 19.51 23.00 28.91 27.97 27.37 45.31 44.43 43.64 Takeda Overseas Sales % 33.82 49.69 54.80 53.16 50.51 52.38 45.27 46.43 47.23 49.68 Source: MP Advisors; Company Reports High Dependence on Domestic Markets + Long Listed Products Makes Do. Cos Vulnerable to Healthcare Reforms 37
  • 38. Revised Incentives For Pharmacies and GE Usage Rate Rate of GE (%) Rate of GE (%) (on prescription basis) GE usage rate (o n volume basis) Relative Cumulative Relative number Cumulative Total Until March, 2010 Since April, 2010 number Total Standard for 9.7 9.7 65%≦ 0.1 0.2 calculation on prescription basis Incentive points (¥) 4.3 14 60%≦ 65% 0.2 0.4 5.5 19.6 55%≦ 60% 0.3 0.7 GE drug 30%≦ 4 points + 13 points 17 points (170yen) 7.4 27 50%≦ 55% 0.5 1.2 usage rate 25%≦ 0 points +13 points 13 points (130 yen) 9.9 36.9 45%≦ 50% 1.0 2.2 20%≦ 0 points +6 points 6 points (60 yen) 13.3 50.3 40%≦ 45% 1.5 3.7 20%> 0 points ±0 points 0 points 16.5 66.7 35%≦ 40% 2.4 6 15.3 82 30%≦ 35% 4.0 10.1 Source: MP Advisors; Company Reports 8.1 90.1 25%≦ 30% 7.3 17.4 5.1 95.2 20%≦ 25% 13.3 30.6 2.6 97.8 15%≦ 20% 25.5 56.1 1.3 99.1 10%≦ 15% 30.7 86.8 0.6 99.7 5%≦ 10% 11.5 98.3 0.3 100 0%≦ 5% 1.7 100 42.6 Average rate 18.2 40.1 Median rate 16.0 Generics Investment Thesis: • Increase in incentives for pharmacies has led to a spur in generic sales (~50% increase in 1Q FY 03/11) • Growth will not continue as number of pharmacies (~82% of total) have now reached the ‘bracket’ that gets the maximum benefit of ‘Rx incentive for generics Incentives for Pharmacies are playing out their maximum impact 38
  • 39. Generic Cos at a Glance Sawai Towa Nippon Chemi 03/10 03/11 03/12 03/13 03/14 03/10 03/11 03/12 03/1 03/14 03/10 03/11 03/12 03/13 03/14 ¥b A E E E E A E E 3E E A E E E E Sales 50.1 61.6 72.3 82.6 90.5 39.0 44.2 49.5 56.2 63.0 24.0 28.6 30.9 33.7 36.1 % Change YoY 13.1 23.0 17.4 14.3 9.5 8.7 13.2 12.1 13.4 12.2 7.5 19.3 7.9 9.1 7.1 COGS 26.3 32.6 38.3 44.2 48.2 18.8 21.3 23.7 26.8 30.0 11.4 14.7 15.8 17.3 18.6 SG&A 11.7 12.8 15.2 17.5 19.1 9.9 11.0 12.3 14.2 16.0 11.8 12.8 13.7 15.0 15.9 % of sales 23.3 20.8 21.0 21.2 21.1 25.5 25.0 24.8 25.3 25.3 47.8 44.8 44.3 44.6 44.1 R&D 3.6 4.2 5.0 5.6 6.4 2.6 3.1 3.4 4.0 4.5 % of sales 7.2 6.8 6.9 6.8 7.1 6.6 7.1 7.0 7.1 7.2 OP 8.5 12.0 13.8 15.3 16.8 7.8 8.8 10.1 11.2 12.5 0.8 1.1 1.4 1.4 1.6 % Margin 17.0 19.4 19.2 18.6 18.6 19.9 19.8 20.4 19.9 19.9 3.2 3.9 4.6 4.0 4.5 NP 5.0 6.6 8.2 9.1 10.0 4.6 5.3 6.1 6.5 7.3 0.3 0.5 0.7 0.7 0.9 % Margin 10.0 10.7 11.4 11.0 11.0 11.8 12.0 12.3 11.5 11.5 1.1 1.9 2.4 2.1 2.4 Source: MP Advisors; Company Reports Generics Investment Thesis: • Broadly generic market is divided into two segments: GP/Dispensing market and DPC market • Companies focusing on the GP/Dispensing market: Companies ability to offer better margins remains the key success factor. Growth in dispensing Pharma market due to increase in incentive of pharmacies. Companies like Towa and Sawai focus on these segments. • Companies focusing on the DPC market : Number of DPC hospitals are >1500 and likely to grow further. Stable supply, availability of formulations at different strengths, and a strong distribution channel with wholesalers are key growth drivers. Companies like Nippon Chemiphar, Eisai’s and Kyorin’s generic divisions etc. focus on this segment. • We expect generics penetration to reach ~8% (by value) by 2012 (Government’s target is 15%. The new patent expiries of ~900b yen in next three years will help generic companies maintain current pace of growth. 39
  • 40. Thank You 40