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GLOBAL BIOPHARMA
  OUTLOOK 2012
LARGE-CAP PHARMA
Vishal Manchanda, B.E., MBA      vishal@mpadvisor.com
Ripple Mehta, B.Pharm, MBA       ripple@mpadvisor.com
Vijayakannan, PhD                vijay@mpadvisor.com


                        +1.646.657.3787
Outlook - 2012
•   Patent Cliff - ~ $50b of patented sales to be genericised – AZN, PFE,
    NVS, SAN, BMY, LLY to bear the pain

•   Innovation to foster growth in several therapeutic areas
     – HCV
     – Metastatic Melanoma
     – New Generation Oral Anti-coagulants
     – Alzheimers
     – Multiple Sclerosis
     – GLP-1’s therapy areas

•   Patent Expiry and Pricing Pressures will intensify M&A activity

•   LLY, AZN, and BMY would go for deals to fuel their topline

                                                                        3
MP Advisors
Patent Expiry Pressures will be at its Peak
                                   2011 Products Sales going off patent
                                                                                                                   Cum ve
                                                                                                                        ulati
             Sales in$m                                                                             Cum veulati
 C pany
  om                                                                                                               Sales Erosion
               (2011)     2011        2012          2013         2014     2015    2016    Company   Sales Erosion
                                                                                                                  11-16 as %of
                                                                                                     11-16 ($b)
                                                                                                                  2011 R evenues
LLY           22,225      4,637                    6,345         1,069            302     LLY          12,353          56%
N O
 OV           11,831                                             3,842    914             NO VO         4,756          40%
AZN           31,711       1,191     5,725          995          7,538            6,539   AZN          21,988          69%
PFE           57,522      13,556     4,317         1,171         2,877    1,268    350    PFE          23,539          41%
BM Y          21,398                 8,200         1,434                  3,908    689    BM Y         14,231          67%
SAN           38,286       264       6,845          232          5,632     637            SA N         13,610          36%
NVS           48,565       923       8,188         2,703          922     5,665           NV S         18,401          38%
M RK          41,018                 6,295         1,368         1,670    1,905   407     M RK         11,645          28%
GSK           43,328                 9,154          589                   1,179           GSK          10,922          25%
RO G          44,735      1,485       747                                  649            ROG           2,881           6%
Total ($)     360619      22056      49471         14837        23550     16125   8287                 134326          37%




              With growth in Western Markets Crumbling to Patent Expiry
                Pressures, Will Emerging Markets offer some respite??
                                                                                                                          4
   MP Advisors
Emerging Market – An Oasis or just a
                   Mirage?
•   China, so far has been the pillar of Emerging Market Growth for Large
    Pharma, but it is also giving away to policy pressures
     – The EDL is expected to double in size, putting pressure on MNC
       growth

     – Reimbursement norms to be tightened

     – Price cuts


• Global recessionary pressures have put Emerging market growth
  forecasts down and should impact the pace of healthcare spending

         A Select few Large Cap Companies are immune to these
             pressures and also offer the promise for growth
                                                                        5
MP Advisors
Our Top and Bottom Picks in the Large Cap
               Space for 2012
Top Picks
•    Roche
•    GlaxoSmithKline

Bottom Pick
•    Bristol-Myers Squibb




                                              6
MP Advisors
Strong double digit EPS growth together with +ve news-flow on
          late stage pipeline will put Roche back in flavor


  Positive clinical data on T-DM1 and approval of Pertuzumab will ease concerns related to
  patent expiry

  HERA study exploring 2 year adjuvant use of Herceptin versus 1 year Adjuvant use

  Interim Analysis from DAL-OUTCOME Study, if positive will lead to a run up in the stock
  price much above our PT of CHF 180

  Avastin may add a couple of more indications – Ovarian Cancer, while we will see pivotal
  data on first line Glioblastoma multiforme, triple negative breast cancer and Treatment
  through multiple lines in colorectal cancer. The late stage trials are supported by clinical
  evidence

  Head to Head study comparing Actemra to Humira – Cross trial comparison suggests non-
  inferior outcome



                                                                                                 7
MP Advisors
GlaxoSmithKline – Upgrade to Outperform
    We anticipate positive data on its Oncology and Respiratory pipeline, which should
    lead to a revision in long term growth forecasts for GlaxoSmithKline

    On Tykerb, ALTTO study exploring Tykerb in combination with Herceptin in
    Adjuvant use in breast cancer will report data and we expect a positive outcome –
    The indication will add £1b pound in peak sales

    GSK’s melanoma pipeline (BRAF inhibitor, MEK inhibitor) is best in class and we
    will see PhIII data

    On the respiratory pipeline, we expect a positive outcome from a host of studies
    exploring Relovair and LABA/LAMA FDC in PhIII trials

    In the rare disease Pipeline Migalastat for Fabry disease is promising and looks
    better than available treatment options (Repligal and Fabrazyme). Head to head
    study comparing Migalastat with Repligal and Fabrazyme should also reveal data

                                                                                    8
MP Advisors
Bristol-Myers – Bottom Pick
    Valuations are rich, patent expiry pressures are peaking and pipeline expectations
    build in more than a bull case

    We see restricted uptake of Eliquis as we believe Eliquis label in SPAF will be no
    better than other approved anticoagulants. Patients adequately controlled on
    warfarin are unlikely to switch as twice daily dosing will be a dampener

    Yeryoy ramp up has been impressive, but the sales will soon plateau as competitors
    will enter and physician will be discouraged to use Yer yoy owing to serious side
    effects and very low response rate. European uptake will be very slow due to
    reimbursement hurdles




                                                                                     9
MP Advisors
Japan Pharma 2012
                                               日本の製薬会社


                            Summary Of Japan Section From ‘Global Bio-Pharmaceutical Outlook-2012’
                                                                  Bio-               Outlook- 2012’

                                     Top Picks : Chugai, Daiichi Sankyo, Torii, Towa
                                         Pos. Invest. Alert: Dainippon Sumitomo
                                                   Bottom Pick : Eisai


                  Devesh Singh, Pharmacist, MBA                                 Vrunda Shah, CFA, MS (Fin)
                  devesh@mpadvisor.com                                              vrunda@mpadvisor.com
                  +1.646.657.1016                                                          +1.646.657.1016


!                                                                                                            10
    MP Advisors
!
Key Take Away
•   Drivers to promote generics are likely to intensify generics pick up from April 2012.

•   2012 price cuts least affecting foreign cos, while Japanese cos are more exposed largely due higher contribution of long-listed drugs and
    variation in innovations premium.

•   Generic growth is inevitable; even after rapid penetration, huge untapped opportunity exists for generic companies.

•   Innovation will continue to drive growth of Japanese majors while only a few promise positive news flow in next 1-2 years.

•   Major Japanese's innovators are not targeting generic opportunities – their focus remains on – innovation & going global. But this trend
    could change in near future.

•   Hybrid pharma began from 2010; and will start playing major role in reshaping Japanese pharma soon. Daiichi Sankyo currently is the only
    company in Japan in hybrid pharma.

•   Consolidation activities in Japan generic will spur: foreign/ non-generic companies have started taking japan generic as one of the growth
    drivers.

•   Japanese majors have poured massive ~$50b in acquiring innovation – next 2-3 years will unfold their success potential.

•   Majority of Japanese pharma cos still struggling with patent expiries; in next 3 years more than ¥900b drugs going to expire.

•   Despite several odds, Japan pharma offers opportunities for both long & short term investors.

                                                                                                                                                 11
MP Advisors
Coverage & Top-Picks
                                                         Market            EPS 4yr
                                                                                      ROE    ROCE             EV/EBI
 Company              Rating             Price   SOS      Cap.    EV-12     CAGR                     P/E-12            TP
                                                                                     03/12   03/12             TDA
                                                          ( ¥b)            (11-15)
 Daiichi Sankyo       Outperform         1562    709.0   1107.5   1089.1     4.9     2.3%    10.3%    16.0     5.3     1850
 Dainippon            Pos. Inv Alert     1141    335.1    382.3    346.8                                               1050
                                                                              5.8    7.0%     9.1%    16.5     6.4
 Sumitomo
 Eisai                Underperform       870     397.9    346.2    341.3      5.5    6.3%     6.6%    32.2     5.2     950
 Takeda               Market Perform     3365    285.1    959.4   1033.3     (9.1)   11.6%   11.5%    17.1     6.7     2500
 Astellas             Market Perform     3770    789.4   2975.9   3345.7    (11.0)   5.8%     8.8%    23.5     7.5     3500
 Shionogi             Market Perform     3435    470.0   1614.5   1373.1      8.4    7.1%    11.6%    22.9     6.6     3200
 Global                                                                              6.7%     9.6%    21.4     6.3
 Chugai               Outperform         1474    544.8    803.0   625.4      11.2    10.8%   15.1%    15.6     6.2     1700
 Mitsubishi Tanabe    Market Perform     1152    561.4    646.7   511.5       5.4    5.4%     8.5%    16.4     5.6     1350
 Kyowa Hakko          Market Perform     882     576.5    508.5   428.5       3.5    5.0%     7.7%    16.9     5.3     950
 Kyorin               Market Perform     1570    74.9     117.6   90.4        0.5    8.7%    12.0%    11.1     4.9     1500
 Domestic                                                                              7%     11%     15.0     5.5
 Towa                 Outperform         3790    17.2     65.1    71.1        5.4    12.6%   14.7%    10.7     5.5     4100
 Sawai                Market Perform     8660    15.7     136.0   143.7      10.9    14.1%   14.9%    14.0     7.9     8200
 Nichi-Iko            Market Perform     1832    30.9     56.6    68.5       12.6    17.2%   22.5%    10.6     6.1     NA
 Nippon Chemiphar     Market Perform     495     38.2     18.9    25.7       36.0    7.9%    10.6%    12.9     7.4     320
 Generic                                                                              13%     16%     12.1     6.7
 Average                                                                             9.0%    12.0%    16.1     6.2
  Price as on 23rd March, 2012
  Source: MP Advisors; Company Reports




 Opportunities Exist For Both Long & Short Term Investors
                                                                                                                              12
MP Advisors
Segments Specific ‘Key Success Factors’
  Segment                          Key Success Factors                                                                                   Top/Bottom Picks
  Innovators
  Domestic focused                 Low % sale coming from long listed products
                                   Late stage R&D – own as well as in-licensed.
                                                                                                                                               Chugai,
                                   Internationalization capabilities                                                                            Torii
                                   Willingness to consolidate
                                   Strong marketing abilities in Japan such that it improves the chances of licensing-in good products

  Global                           Higher overseas exposure
                                                                                                                                           Daiichi Sankyo,
                                   Lower long listed drugs contribution                                                                         Eisai
                                   Rich PhIII pipeline
  Generics

               GP1/DP2             Strong marketing infrastructure with sales force and rapport with GP / DP

                                   Oral formulations etc.
                                                                                                                                                Towa
            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
     Source: MP Advisors




       JP Specific Drivers Will Continue To determine Success
                                                                                                                                                             13
MP Advisors
Japan Pharma – Market Model
                                                 Mar-11 Mar-12 Mar-13 Mar-14 Mar-15 Mar-16 Mar-17 Mar-18 Mar-19 Mar-20
Total Rx Market                                   7,802 8,036 8,277 8,526 8,781 9,045 9,316 9,596 9,883 10,180                     Every year new patent
  % Change                                         3.0%    3.0%    3.0%    3.0%    3.0%    3.0%    3.0%    3.0%    3.0%    3.0%    expiries keep on
New pt Exp. (¥b)                                  294.0   387.5   331.9   341.7   195.0   466.0   443.0   522.0   400.0   450.0    increasing potential
Total Long Listed Products Price Adj             3,358.6 3,712.5 3,970.1 4,272.1 4,125.4 4,550.1 4,629.1 5,104.8 5,096.4 5,495.5   target market for
Long Listed drugas as % of Total DO Market         43%     46%     48%     50%     47%     50%     50%     53%     52%     54%     generic cos. This leads
TOTAL Market Available for Generics               3,359   3,713   3,970   4,272   4,125   4,550   4,629   5,105   5,096   5,495    to higher generic
Hospital Market (DPC Affiliates )                                                                                                  opportunity despite
No of DPC Hospitals                               1393    1452    1496    1525    1556    1587    1619    1651    1684    1718     robust generic growth.
 # of beds in DPC hospt. In Japan ('000)           494     504     514     524     534     545     556     567     578     590
 Total # of beds in Japan ('000)                   913     913     913     913     913     913     913     913     913     913
 % of total beds in Japan                         54%     55%     56%     57%     59%     60%     61%     62%     63%     65%
% of total beds in Japan                          47%     48%     49%     49%     50%     50%     51%     51%     52%     52%
  % Change                                          2%      2%      2%      1%      1%      1%      1%       1%      1%      1%
Total NRx generated as % of Total Market          37%     38%     38%     39%     39%     39%     40%     40%     41%     41%
Total DPC Market size (available for generics)    1235    1393    1519    1651    1611    1794    1844    2053    2070    2255
Drivers of Generics use                                                                                                            Increase in DPC
 Cost saving measures                              10%     10%     13%     14%     17%     17%     20%     20%     23%     25%     hospitals will be a
 Due to Co-payment                                  3%      3%      3%      3%      3%      3%      3%      3%      3%      3%     largest Generic growth
 Others factors                                     2%      2%      3%      2%      6%      6%      7%      5%      7%      4%     catalyst in future.
Consolidate impact of all Drivers                  15%     15%     19%     19%     26%     26%     30%     28%     33%     32%
Total Generics Sales at DPC Hospitals             185.3   208.9   288.7   313.8   418.8   466.5   553.1   574.9   683.3   721.6
   % Change                                        10%     13%     38%      9%     33%     11%     19%      4%     19%      6%
DPC Hospt Generics Sales as % of Total sales      2.4%    2.6%    3.5%    3.7%    4.8%    5.2%    5.9%    6.0%    6.9%    7.1%
                                                   15%     15%     19%     19%     26%     26%     30%     28%     33%     32%
                                                                                                                                   Various growth catalyst
Non-DPC Market
                                                                                                                                   together boost Generics
Total Non-DPC Market (GPs/Clinics/small hopt/     2,123 2,320 2,451 2,621 2,515 2,756 2,786 3,051 3,026 3,241
                                                                                                                                   penetration.
Total GP's/dipensing/clinics Market               516.6 598.0 717.6 803.7 932.3 1034.9 1210.8 1356.1 1559.5 1715.5
   % Change due to Reforms/ Drivers              22.5% 15.8% 20.0% 12.0% 16.0% 11.0% 17.0%         12%    15%    10%
 % of total Non-DPC generic market                 24%   26%    29%    31%    37%    38%    43%    44%    52%    53%
 % of Total Rx market                             6.6% 7.4% 8.7% 9.4% 10.6% 11.4% 13.0% 14.1% 15.8% 16.9%
  Years from FY 03/12                                       0      1      2      3      4      5      6      7      8
Total Generic market (by value in ¥b)             702.0 807.0 1006.3 1117.5 1351.1 1501.4 1763.9 1931.1 2242.8 2437.1
                                                                                                                                    Despite high growth,
  % change                                        19.0%   15.0%   24.7%   11.0%   20.9%   11.1%   17.5%    9.5%   16.1%    8.7%     penetration will remain
Generics as % of Total Market                      9.0% 10.0% 12.2% 13.1% 15.4% 16.6% 18.9% 20.1% 22.7% 23.9%                       as low as <12% (by
                                                                 15                                                                 val) in GP/DP market
GP/DP to DPC Market Share Ratio                      1.7   1.7   1.6   1.6   1.6   1.5   1.5   1.5   1.5   1.4                      by 2016.
                                                                                                                                                    14
MP Advisors
    Despite Rapid Penetration, Huge Untapped Opportunity Exists for Generic Companies
Major Japanese M&A in Last 4 Yrs
                                                                                    Premium to
                                             Acquired     Acquisition   Cash paid
          Company                                                                    3m. Avg
                                             Company         date         ($b)
                                                                                    price. (%)
          Takeda                            Nycomed       19-May-11       13.50         NA
          Takeda                            Millennium    10-Apr-08       11.00       71.00
          Daiichi Sankyo                    Ranbaxy       11-Jun-08       4.60        50.00
          Astellas                          OSI           17-May-10       4.00        55.00
          Eisai                             MGI           10-Dec-07       3.90        37.48
          Dainippon Sumitomo Sepracor                      3-Sep-09       2.60        37.86
          Shionogi                          Sciele         1-Sep-08       1.42        57.55
          Daiichi Sankyo                    Plexxikon     28-Feb-11       0.80         NA
          Hisamitsu                         Noven          14-Jul-09      0.43        43.00
          Taisho Pharma                     BMY’s Units   16-Sep-09       0.31         NA
          Eisai                             AkaRx Inc     18-Dec-09       0.26         NA
          Nipro Pharma                      Home Diag.    17-Mar-10       0.18         NA
          Total Cash Paid                                                 43.00
           Source: MP Advisors; Company Reports




Massive Money Poured Overseas Remain Questionable For Most -
                  Takeda Biggest Looser!
                                                                                                 15
 MP Advisors
Average Price Cuts And Reforms 2012

                                                                                                                 Yakka-Sa vs. Price Cuts

Price Cuts Came As Expected:                             25.0
                                                                          23.1
•   ~6% overall and Additional price cut for             20.0
    off-patent brands                                                                     17.8
                                                         15.0




                                               % Value
                                                                                                          14.5
                                                                                                                          13.1
•   Premium for New Drug Development                                                                                                                                                                                     8.4
    will continue in 2012 reforms                        10.0                                                             9.7              9.5
                                                                                                                                                                                 6.7                              8.4
                                                                          6.6             6.8                                              7.0             7.1                                     6.9
                                                                                                                                                           6.3             6.3                                    5.8
                                                          5.0                                                                                                                    6.5               5.2
                                                                                                          4.4                                                                                                             6.2
•   Lower price cuts for Original Drugs                                                                                                                                    4.2

                                                          0.0




                                                                                                                                                                                                                         2012 E
                                                                 1992 A


                                                                                 1994 A


                                                                                                 1996 A


                                                                                                                 1998 A


                                                                                                                                  2000 A


                                                                                                                                                  2002 A


                                                                                                                                                                  2004 A


                                                                                                                                                                                 2006 A


                                                                                                                                                                                          2008 A


                                                                                                                                                                                                         2010 A
•   High Yakka-sa for Vasodolators (11.6%),
    Peptic ulcer drugs (10.8%) and Anti-
                                                                                                                                                 Year
    allergic drugs (10.5%)
                                                                                                                                 Price Cuts                      Yakka Sa

•   Foreign cons are least affacted while
                                                                Source: MP Advisors; MHLW
    Eisai is most affacted with >11% price
    cuts



                                                                                                                                                                                                                        16
MP Advisors
Average Price Cuts in 2012




                 Source: MP Advisors; MHLW

MP Advisors
              Foreign Cos are least affected while Eisai is most affected co.   17
Long Listed Exposure vs. Overseas Sales
                                  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    47.79    53.24    52.54    46.83    42.63    35.14
                                                                                                                                       Astellas
      Overseas Sales %           46.77      45.77    43.49    42.08    39.14    39.66    38.70    39.96    41.93    44.40
      Long L As % of DO   Sales 32.12      26.80    18.51    22.11    23.93    19.41    16.01    13.34    11.11     9.39
                                                                                                                                        Chugai
      Overseas Sales %           9.72       9.70     6.25     7.99    10.92    13.49    14.02    14.16    13.83    13.91
      Long L As % of DO   Sales            28.98    31.81    47.26    52.22    46.35    41.66    37.43    35.14    33.19
                                                                                                                                Daiichi Sankyo
      Overseas Sales %                      38.6     44.7     50.4     49.4     46.1     49.7     48.2     51.6     53.1
      Long L As % of DO   Sales    43.13    41.04    71.73    70.01   63.92    61.47    57.93    61.98    58.83    55.54
                                                                                                                          Dainippon Sumitomo
      Overseas Sales %              7.31     7.99     7.27    17.80   40.11    36.04    36.38    33.98    29.44    29.35
      Long L As % of DO   Sales   28.02    26.21    28.69    27.95    42.81    72.55    67.69    65.62    60.16    55.53
                                                                                                                                          Eisai
      Overseas Sales %            57.30    58.53    64.26    61.56     54.4     44.7     48.1     47.4     49.7     52.0
      Long L As % of DO   Sales   41.40    39.32    32.81    29.93    29.09    28.15    26.61    25.27    24.01    22.80
                                                                                                                                         Kyorin
      Overseas Sales %             4.15     3.70     2.75     2.38     2.19     2.00     1.85     1.80     1.67     1.55
      Long L As % of DO   Sales    68.05    65.11    64.89    71.78   42.79    35.69    38.53    49.22    73.68    46.28
                                                                                                                           Kyowa Hakko Kirin
      Overseas Sales %              3.44     4.16     6.32     4.89     5.8      9.4     12.8     13.2     13.6     14.0
      Long L As % of DO   Sales    65.11    60.68    60.93    58.27   60.03    56.58    55.15    52.34    66.31    67.45
                                                                                                                            Mitsubishi Tanabe
      Overseas Sales %              5.81     6.10     5.65     5.20    5.29     5.87     6.32     6.65     6.80     6.57
      Long L As % of DO   Sales   44.85    39.67    49.65    42.22    38.13    33.38    29.55    25.97    26.68    23.55
                                                                                                                                      Shionogi
      Overseas Sales %            14.44    15.81    24.65    36.33     36.5     31.0     27.2     25.0     25.0     26.0
      Long L As % of DO   Sales    14.93    19.31    19.55    23.00   32.91    30.44    37.65    36.43    53.33    52.08
                                                                                                                                        Takeda
      Overseas Sales %             33.82    49.69    54.86    53.24   49.17    51.26    50.60    50.24    51.04    53.36
       Source: MP Advisors; Company Reports

Global Cos Increasing Dependence on Domestic Markets + Long Listed
                             Products
            Makes them Vulnerable to Healthcare Reforms
                                                                                                                                        18
MP Advisors
Reforms Promoting Both Generic Penetration and
                 Innovation
                       Reforms That Will Increase The Use Of Generic Drugs
   Near term impact (0-2 years)                                          Long term impact (>2yrs+)

   • Higher Dispensing Fee                                               • Patients Co-payment

   • Prescription Using Generic Name                                     • Freedom To Stock One Generic Brand

   • DPC Expansion                                                       • DPC For Out-patients

   • Incentive To Physicians                                             • Free Pricing For Generic Drug

   • Mandatory Approval Of All Strengths                                 • Incentive To Pharmacies For Generics Drugs Availability


                                                       Reforms That Will Foster Innovation
   Near term impact (0-2 years)                                              Long term impact (>2yrs+)

   Reforms That Will Foster Innovation

   • Increased Number Of Reviewers                                           • Cost Based Pricing

   • Better Clinical Trials Infrastructure & Support                         • No Price Cuts During Patent Period

                                                                             • Free pricing of all drugs




    Source: MP Advisors; MHLW                                                                                                        19
 MP Advisors
Reforms to be Implemented From April 2012
Reform                                      Description                                                  Impact                                                   Biggest Beneficiary
                                                                                                                                                                  Companies

Premium for generics dispensing             Further increase in incentive for pharmacist; likely to be   Higher generic substitution at dispensing pharmacy
                                            in pocket of those who dispensed more than 30% of                                                                        Sawai, Towa, Nichi-Iko
                                            generic

Higher bonus points to Hospitals for more   Awarding higher bonus point to hospitals using atleast       More Rx on generic drugs to generate to get more
usage of generics                           30% generics (35 points); Hospital using atleast 20%         bonus points
                                            awarded points reduced from 30 to 28 points.                                                                             Sawai, Nichi-Iko



Higher discount to new generic launch       First generic version set to be min 40% discount to          Increasing discount will make generic drugs more
                                            branded drug instead of current 30% discount.                competitive against long listed drugs                       All generic companies


Reducing the difference in price of         Currently there is huge price difference between the two     Reducing the gap at lower end will make generic dugs
Generic drugs                               brands of generics.                                          more competitive to long listed as well as among            Towa, Sawai, Nichi-Iko
                                                                                                         generic drugs.

Change in Rx-format                         Removal of ‘no substitution permitted’ column from           Increase generic substitution at pharmacy
                                            current Rx format and compulsory writing the generic
                                            name of the drug.                                                                                                        All generic companies



Increase in management and guidance fee     Points awarded to pharmacies for providing drug history      More Rx on generic drugs to generate
                                            management and guidance will rise to 41 points, from 30
                                            points at present                                                                                                        All generic companies



Abolition of premium for GE dispensing      The abolition of the extra two points awarded to             Impact negatively to the sales of newly listed generic
Source: MP Advisors; MHLW
and GE information provision fee            pharmacies for dispensing generic drugs and the 15 points    drugs
                                            for providing drug information                                                                                           All generic companies




                                                                                                                                                                                              20
MP Advisors
Revised Incentives For Pharmacies
                                                    Revised Incentive for Pharmacies
            Old                         Generic Rx by Volume        0% - 19%   20%-24%   25%-29%   >=30%




            Before April 2010           Incentives for Pharmacy /   NA         NA        NA        ¥40
                                        Patient

            From April 2010                                         NA         ¥60       ¥130      ¥170

            New Effective from (April   Generic Rx by Volume        0% - 21%   22%-29%   30%-34%   >=35%
            2012)

                                        Incentives for Pharmacy /   NA         ¥50       ¥150      ¥190
                                        Patient

            Difference                                                         ¥10       ¥20       ¥20

            Source: MP Advisors; Company Reports



 Generics Investment Thesis:
• Increase in incentives for pharmacies has led to a spur in generic sales (~22% increase in
  FY 03/11)
• Pharmacies which currently falls under 25%-29% slab will be encourage to boost their
  generic uptake to at least 30% to avail higher bonus points.


  Revised Incentives Will Boost Generics Uptake To New Level
                                                                                                           21
MP Advisors
Segment Specific ‘Key Success Factors’
                                                                                                          Lupin
                                                                                 Self/Agencies


•   All generic companies position
                                                                                                                         Towa
    themselves into two broad segments
    and distribution channels                                                                                      M.
                                                                                                                           Sawai
                                                                                                                  Tana
                                                                                                                   be


•   For Generics, Marketing/Branding                                                        Nichi
    capabilities in GP/Dispensing pharma       DPC
                                                                                             Iko

    market, and distribution capabilities                                           Nippo
                                                                                      n
                                                                                                           GP/Dispensing
    into DPC/large hospitals segment will   Kyorin
                                                                                    Chemi                        Pharma
                                                                                     phar
    determine success.                                 Meiji

                                                                                                    DSE

                                              Elmed          N.
•   Near term opportunity lies in                          Kayaku

    GP/Dispensing Pharma segments, and
    Towa & Sawai appeared best
    positioned to leverage benefits from
    pro-generic reforms.
                                                                                    Wholesalers
                                                     Positioning of Japanese generics Cos*
                                                     *Illustrative only
                                                     Source: MP Advisors, Company Reports
                                                                                                                                22
    MP Advisors
Approaching Generic Opportunities in Next
                  3 Years
                                                                                                  FY 03/11 Sales
               Product                              Generic name             Marketed by              in ¥b
                                                             2012
               Leuplin                              leuprorelin acetate      Takeda                    64.3
               Nu-lotan                             losartan                 MSD                      40.08
               Paxil                                Paroxetine               GSK                      39.35
               TS-1                                 NA                       Taiho                    38.31
               Myslee                               Zolpidem                 Astellas                 31.69
               Allelock                             olopatadine hydrochlorid Kyowa Hakko Kirin        29.23
               Seroquel                             quetiapine               Astellas                  25.7
               Gasmotin                             mosapride citrate        Dainippon Sumitomo       20.06
               Arimidex                             anastrozole              AstraZeneca              19.23
               Norditropin                          somatropin(genetical recoNovo Nordisk             17.66
               Lantus                               INSULIN GLARGINE         Sanofi Aventis           12.17
               Humalog                              Insulin Lispro           Eli Lilly                12.15
               Funguard                             micafungin sodium        Astellas                 12.11
               Total Key Products Expiry in 2012                                                     362.03
                                                               2013
               Diovan                               valsartan                Novartis                110.59
               Remicade                             infliximab               Mitsubishi Tanabe        63.25
               Livalo                               Pitavastatin             Kowa                     31.54
               Loxonin Tape                         loxoprofen               Daiichi Sankyo           22.02
               Valtrex                              Valaciclovir             GSK                      19.37
               Ceredist                             taltireline              Mitsubishi Tanabe         18
               Zithromac                            azithromycin             Pfizer                   15.29
               Taxol                                paclitaxel               Bristol                  13.88
               Flolan                               Epoprostenol             GSK                      11.11
               Total Key Products Expiry in 2013                                                     305.06
                                                              2014
               Blopress                              Candesartan              Takeda                 119.93
               Allegra                               fexofenadine             Sanofi Aventis          48.66
               Glivec                                imatinib                 Novartis                38.09
               Rituxan                               Rituxicimab              Chugai                  24.69
               BI Sifrol                             NA                       Boehringer               13.1
               Oxarol                                maxacalcitol             Chugai                  13.06
               Mearubik                              measles & rubella vaccineMitsubishi Tanabe       12.46
              Source: MP Advisors
               Claritin                              Loratadine               Shionogi                10.16
               Total Key Products Expiry in 2014                                                     280.14
                                                                                                                   23
MP Advisors    Total Key Products Expiries in next three years                                       947.23
Foreign Companies Entry In Japan Generic
                     Market
      Foreign             Domestic Company            Year   Comment
      Company
      Sandoz              Nippon Hexal                2006   First to launch generic recombinant in 2009
      Hospira             Taiya Yakuhin               2006   Developed injectable generics
      Lupin               Kyowa Pharma                2007   Lupin acquired majority stake in Kyowa
                                                             pharmaceuticals industries
      Zydus               Nippon Universal            2007   Launched Zydus Pharma Inc. in 2006 and stared
                          Pharma                             operation with acquisition of Nippon Universal
                                                             Pharma in 2007
      Mylan                –                          2008   Acquired generic business of Merck
      Ranbaxy             Daiichi Sankyo              2008   Daiichi acquired Ranbaxy
      Teva                Kowa Pharma                 2009   Established joint venture
      GSK                 JCR Pharma                  2009   Signed agreement with GSK for manufacturing
                                                             Bio-similar, launched generic EPO in Japan

      Actavis             Aska Pharma                 2009   Established joint venture
      PharmaForce         Luitpold (Daiichi Sankyo)   2010   Daiichi Sankyo subsidiary acquired PharmaForce,
                                                             a generic injectable maker in US

      Sanofi-Aventis      Nichi-Iko Pharma            2010   Established joint venture
      Teva                Taiho Pharma                2011   Teva acquired majority stake in Taiho Pharma
      Dr. Reddy’s         Fuji Film                   2011   JV announced. Fuji is new in pharma business
      Lupin India         I’rome                      2011   Acquired. I’rome has Injectables facility
     Source: MP Advisors, Company Reports



         Expect More Consolidation Activities in Coming Days!                                                  24
MP Advisors
Investment Ideas -2012
                      Outperforms :
                          Chugai
                      Daiichi-Sankyo
                           Torii
                           Towa

                           PIA:
                    Dainippon Sumitomo

                      Underperform:
                          Eisai



                                         25
MP Advisors
CHUGAI (4519, ¥1,237) – Outperform
                                                      2012 Going to Be Happening!

                 Fiscal Year      Total      %     Gross       Op.         %      Op.    EV/       Net     EPS      %     PE     CFPS      PCF
                    (¥ b)         Rev.      Chg.   Margin     Profit     Chg. Margin EBITDA Profit          (¥)    Chg.   (x)     (¥)       (x)
                   2010 A         379.5   (11.5)   57.20       66.2      (19.7)   17.4   6.0       41.4    75.9    (26.1) 16.4   (11.8)    (105)
                   2011 E         394.2     3.9    57.98       71.9       8.7     18.2   5.6       43.6    80.0     5.4   15.5   111.8     11.1
                   2012 E         416.6     5.7    58.65       82.2      14.4     19.7   4.9       51.6    94.7    18.4   13.1   76.3      16.3
                   2013 E         430.9     3.4    59.22       88.2       7.3     20.5   4.6       55.5    102.0    7.6   12.2   89.9      13.8
                   2014 E         449.2     4.2    60.10      100.0      13.4     22.3   4.1       63.2    116.0   13.8   10.7   101.5     12.2
                   2015 E         471.4     4.9    61.22      115.6      15.6     24.5   3.6       73.3    134.5   15.9   9.2    117.6     10.6
                   2016 E         498.1     5.7    62.56      135.6      17.3     27.2   3.2       86.1    158.0   17.5   7.9    138.4      9.0

                 SOS (m):           544.8    Dividend:      40.0      Cash + Inv (¥b):         160.9   4 yr EPS CAGR (12/10-12/14):         11.2
                 Mkt Val (¥ b):     677.2    Yield (%):     3.22      LT Debt (¥ b):             0.0   4 yr EPS CAGR (12/11-12/15):          13.9
                 Mkt Val ($ b):      7.96    forex ¥ /$:    80.0      PEG (2011/2011-2015)      1.41   12 Month Target (¥):               ¥ 1,500



   Investment Thesis:

   2012 will unfold a number of important catalysts and bring upside to this ‘least risk carrying company’ of Japan – these are –

   1. Data that will claim Actemra’s label expansion and its likely filing for 1st line RA in the US
   2. Positive news flow from Roche’s multinational studies, especially around its growing breast cancer franchise i.e. pertuzumab and T-DM1
      and their filings in Japan
   3. Safe domestic business and sales ramp up of newly launched products in Japan - Mircera (approved April-11, peak sales pot. ¥40b) and
      Edirol (launch April-11, peak sales pot. ¥15b), and
   4. A likely increase of Roche’s stake in Chugai as the basic agreement that prevented Roche from increasing its stake will expire in Oct-12.
                                                                                                                                                    26
MP Advisors
Upcoming Milestones
                                                                                          Price
                                                                                        Impact




                                                                     Period


                                                                               Year
                                                                                                If   Expect
              Drug         Event              Description                              If
                                                                                              Neg     ation
                                                                                      Posi
                                                                                              ativ
                                                                                      tive
                                                                                                e
                         Clinical    Head to Head study vs.
           Actemra                                                  1Q        2012    High   Med     Positive
                         data        Humira (ADACTA study)
                                     PhIII data from overseas
                         Clinical
           T-DM1                     EMILIA study 2nd line HER      1H        2012    Low    Low     Neutral
                         data
                                     2+ BC
                                     Metastatic breast cancer HER
           T-DM1         US filing   2+ second-line based on        1H        2012    High   Low     Neutral
                                     EMILIA study
                         Corporate   Roche may increase its stake
           NA                                                       Oct       2012    High   Low     Positive
                         event       in Chugai
                                     US approval in mBC HER2+
                         US
           Pertuzumab                firstline based on PFS data    2H        2012    High   Low     Positive
                         approval
                                     with Herceptin
           Pertuzumab    JP Filing   As adjuvant to Herceptin       2H        2012    Med    High    Positive
           Actemra       US filing   DMARD IR first line filing     2H        2012    Low    low     positive
           Actemra       US filing   For SC formulations            2H        2012    High   High    Positive
           Tarceva       JP Filing   Filing for 1st line NSCLC      2H        2012    Med    Med     Positive
                         Clinical    SC vs. IV (SUMMACTA            Any
           Actemra                                                            2012    Low    Low     Positive
                         data        PhIII study)                   time
           T-DM1         JP Filing   JP filing                      1H        2013    Med    Med     Positive
          Source: MP Advisors, Company Reports



                                                                                                                27
MP Advisors
DAIICHI SANKYO (4568, ¥1,466) – Outperform
                                                  ‘Hybrid Tree’ Is Ready to Give Fruits!
               Fiscal Year     Total       %      Gross     Op.       %      Op.        EV/       Net       EPS       %     PE     CFPS    PCF
                   (¥ b)        Rev.      Chg.    Margin   Profit   Chg.    Margin     EBITDA    Profit      (¥)    Chg.    (x)     (¥)     (x)
                MAR-11 A       967.5      1.6      70.9    122.3    28.1     12.6       5.4       70.3      99.2    68.0    14.8 158.6     9.2
                MAR-12 E       945.4      (2.3)    71.1    114.8    (6.1)    12.1       5.4       20.5      29.0    -70.8   50.6   19.5    75.3
                MAR-13 E       1,009.4    6.8      70.6    127.6    11.2     12.6       5.0       69.1      97.4    236.5   15.0   74.0    19.8
                MAR-14 E       1,095.2    8.5      70.8    141.7    11.1     12.9       4.7       80.8      114.0   17.0    12.9 126.7     11.6
                MAR-15 E       1,133.9    3.5      70.7    150.2     5.9     13.2       4.6       85.1      120.0    5.3    12.2 146.8     10.0
                MAR-16 E       1,190.5    5.0      70.9    161.2     7.4     13.5       4.4       90.6      127.9    6.5    11.5 150.1     9.8
                MAR-17 E       1,198.0    0.6      70.8    162.2     0.6     13.5       4.3       90.2      127.2    -0.5   11.5 171.4     8.6

              SOS (m):            709.0     Dividend:       60.0    Cash + Inv (¥b):          287.95      4 yr EPS CAGR (3/11-3/15):         4.9
              Mkt Val (¥ b):    1,039.4     Yield (%):      4.09    LT Debt (¥ b):            227.53      4 yr EPS CAGR (3/51-3/16):        45.0
              Mkt Val ($ b):      12.92     forex ¥ /$:     80.0    PEG (3/11 / 3/11-3/15):     3.03      12 Month Target (¥):            ¥1,850



 Investment Thesis:
 •   R&D attractiveness – Pipeline is full of late stage candidates which will fetch attention in 2012. Edoxaban (Ph III, factor Xa inhibitor, AF), ARQ 197
     (Ph III, c-met inhibitor, NSCLC), Denosumab (Approved in JP in 2012, bone metastatase), Vemurafenib (US approval in Aug-11, Approved in EU in
     2012, BRAF inhibitor, meladnoma) and CS-8958 (approved in JP, Ph III for prophylaxis anti-influenza) remain growth drivers.
 •   RBXY’s Solid Growth Prospects Beyond Near Term Concerns: 2012-14 brings a number of First-to-File (FTF) opportunities for RBXY, together they
     translate into $1.2b opportunity and a number of Para IV milestones will again bring RBXY in forefront in 2012. We find that near term concerns are
     overly built regarding compromised Lipitor generic opportunity and probable FDA penalty (DS made provision of $500m).
 •   Ability to exploit Japanese generic growth – with Daiichi Sankyo Espha, it is the only Japanese major well positioned to encash Japan generic
     opportunity
 •   Geographic diversity and Revenue Sustainability – DS has major geographic presence which is likely to increase with time; DS is able to maintain
     ~90% of its current revenue base thru FY 03/17 i.e. excluding R&D pipeline contribution - a feature that most of JP peers lack.
 •   Upside From Onetime Cash Flow: Coming quarters may unfold some agreements with global giants on its PhII onco candidates, global rights of
     Edoxaban etc.
                                                                                                                                                    28
MP Advisors
Key Pipeline Candidates
               Development      Drug Class           Indications      Market       Stage     Origin
                  code
               PLX4032       BRAF inhibitor     Melanoma              EU         Approved   Plexxikon
                                                                      US         Approved
                             Anti-RANKL         Bone metastases of    JP         Approved
               AMG-162       antibody           cancer                                       Amgen

                                                Osteoporosis          JP         Filed
                                                RA                    JP         PhI
                             Anti-platelet      Acute coronary        US/EU      P3
               CS-747        agent              syndrome-MM
               Prasugrel                                                                     In-house
                                                 Acute coronary       JP         P3
                                                syndrome-PCI
                             Factor Xa          Atrial fibrillation   US/EU/JP   P3
               DU-176b       inhibitor
                                                Venous                US/EU/JP   P3          In-house
                                                thromboembolism
               ARQ-197       c-Met inhibitor    anti-cancer           US/EU      P3          ArQule
                             Neuraminidase      Anti-Influenza        US/EU      P1
               CS-8958
                             inhibitor                                                       In-house
                                                                      JP         Approved
                             Anti-DR5           Target tumor cells    US/EU/JP   P2
               CS-1008                                                                       In-house
                             antibody
                             PPAR gamma         NSCLC                 US/EU      P2
               CS-7017
                             activator                                                       In-house
                                                                      JP         P1
                             Anti-HER3                                US/EU      P2            U3
               U3-1287
                             antibody                                                        Pharma
                             Fms/Kit/Flt3-ITD                         US         P2
               PLX3397       inhibitor                                                      Plexxikon
                             Anti EGFR                                JP         P2          CIMYM
               DE-766
                                                                                            Bioscience
                             Chymase            Atopic Dermatitis     US         P2          Asubio
               SUN 13834     inhibitor                                                       Pharma
                                                                                                         29
MP AdvisorsSource: MP Advisors; Company Reports
TOWA (4553, ¥3,395) – Outperform
                                       Performance Will Outcast New ‘Mid Term Plan’
                Fiscal Year    Total       %     Gross     Op.       %      Op.        EV/       Net       EPS      %      PE    CFPS       PCF
                   (¥ b)       Rev.       Chg.   Margin   Profit   Chg.    Margin     EBITDA    Profit      (¥)    Chg.    (x)     (¥)       (x)
                  03/11 A       46.1      18.2    53.7     9.7     24.6     20.9       4.5        5.8      339.3   26.7    9.8   (271.2) (12.3)
                  03/12 E       50.2      8.8     53.7     9.9      2.5     19.7       4.4        5.9      342.5    0.9    9.7   (12.3) (270.5)
                  03/13 E       56.7      12.9    52.5    10.3      3.8     18.1       3.9        6.1      355.5    3.8    9.4   (512.2)    (6.5)
                  03/14 E       61.9      9.1     52.6    11.2      9.1     18.1       3.6        5.9      388.3    9.2    8.6   196.1      17.0
                  03/15 E       66.4      7.4     52.7    12.1      8.0     18.2       3.4        6.7      419.5    8.0    8.0   459.6      7.3
                  03/16 E       71.1      7.1     52.8    13.1      8.2     18.4       3.2        7.2      454.3    8.3    7.3   501.9      6.6

              SOS (m):             17.2    Dividend:       65.0    Cash + Inv (¥b):             9.5      4 yr EPS CAGR (3/11-3/15):            5.4
              Mkt Val (¥ b):       58.3    Yield (%):      1.91    LT Debt (¥ b):              10.4      4 yr EPS CAGR (3/12-3/16):            7.3
              Mkt Val ($ b):     0.686     forex ¥ /$:     80.0    PEG (3/11 / 3/11-3/15):     1.35      12 Month Target (¥):              ¥ 4,100

 Investment Thesis:
     Mid-Term Plan (MTP) announced on Nov-11 projects single digit revenue growth vis. a vis. larger increase in R&D and depreciation. Our analysis
     suggests that management has negated key positive components in its MTP and see several reasons why actual results will exceed these projections

 •   In its Assumptions, Towa Does not Expect Any ‘New Major Reform’ Enhancing Generics Uptake In Next 3-Years – our take is that there would be
     a few ‘major changes’ in April-12 and April-14.
 •   MTP Assumes No Fundamental Reform On NHI Pricing System: Chuikyo’s chemist survey results came after Towa MTP find that current Yakka-sa
     is ~8.4%. Early signals suggest that general price cuts would be ~6% while there may be additional price cuts on long listed drugs.
 •   Investment Plans – Capex plans indicate good capicity to meet demand in future.
 •   Towa Has always exceeded its MTP: management has been conservative unlike its peers
 •   Besides the above, we find the following catalysts to also support valuation:
               1. Acquisition Target
               2. Relative Standing vs. Peers on Valuation
               3. Healthcare Reforms in April-12: Incentive to Pharmacies, Change in Generic Pricing Policy etc.                           30
MP Advisors
Reforms to be Implemented in April-2012 and
                   Implications
  Reform                             Description                                     Impact                                            Biggest
                                                                                                                                       Beneficiary
                                                                                                                                       Companies

  Premium for generics dispensing    Further increase in incentive for pharmacist;   Higher generic substitution at dispensing
                                                                                                                                       Sawai, Towa,
                                     likely to be in pocket of those who dispensed   pharmacy
                                                                                                                                       Nichi-Iko
                                     more than 30% of generic
  Higher bonus points to Hospitals   Awarding higher bonus point to hospitals        More Rx on generic drugs to generate to get
  for more usage of generics         using atleast 30% generics (35 points);         more bonus points
                                     Hospital using atleast 20% awarded points                                                         Sawai, Nichi-Iko
                                     reduced from 30 to 28 points.

  Higher discount to new generic     First generic version set to be min 40%         Increasing discount will make generic drugs
                                                                                                                                       All generic
  launch                             discount to branded drug instead of current     more competitive against long listed drugs
                                                                                                                                       companies
                                     30% discount.
  Reducing the difference in price   Currently there is huge price difference        Reducing the gap at lower end will make
                                                                                                                                       Towa, Sawai,
  of Generic drugs                   between the two brands of generics.             generic dugs more competitive to long listed as
                                                                                                                                       Nichi-Iko
                                                                                     well as among generic drugs.
  Change in prescription format      Removal of ‘no substitution permitted’          Increase generic substitution at pharmacy
                                     column from current Rx format and                                                                 All generic
                                     compulsory writing the generic name of the                                                        companies
                                     drug.
  Increase in management and         Points awarded to pharmacies for providing      More Rx on generic drugs to generate
  guidance fee                       drug history management and guidance will                                                         All generic
                                     rise to 41 points, from 30 points at present                                                      companies

  Abolition of Premium for GE        The abolition of the extra two points awarded   Impct negatively to the sales of newly listed
  Dispensing and GE information      to pharmacies for dispensing generic drugs      generic drugs                                     All generic
  provision fee                      and the 15 points for providing drug                                                              companies
                                     information
                                                                                                                                                     31
MP Advisors MHLW
 Source: MP Advisors;
TORII PHARMA (4551, ¥1,462) – Outperform
                                                A Bet That Offers Only Upside!
             Fiscal Year     Total      %     % Gross    Op.        %      % Op.      EV/     Net       EPS       %      PE       CFPS    PCF
                 (¥ b)       Rev.      Chg.    Mgn      Profit    Chg.     Mgn       EBITDA Profit       (¥)     Chg.    (x)       (¥)     (x)
              MAR-11 A       45.34     6.9     59%      1.85      (69.8)    4%         9.4    0.93      33.0    (74.3)   44.3      8.7    167.1
              MAR-12 E       49.26     8.7     59%      1.68      (9.3)     3%         9.2    1.10      38.8     17.5    37.7     28.4    51.6
              MAR-13 E       51.66     4.9     59%      2.63      56.9      5%         7.5    1.65      58.3     50.4    25.1     38.7    37.8
              MAR-14 E       53.39     3.3     60%      3.32      26.3      6%         6.6    2.05      72.5     24.3    20.2     45.4    32.2
              MAR-15 E       59.84     12.1    60%      5.24      57.8      9%         4.7    3.17     111.9     54.3    13.1     78.7    18.6
              MAR-16 E       70.64     18.0    61%      6.90      31.7      10%        3.8    4.13     145.9     30.4    10.0     107.8   13.6
              MAR-17 E       85.42     20.9    61%      9.53      38.0      11%        2.8    5.65     199.7     36.9    7.3      157.5    9.3

            FD SOS (m):         28.3    Dividend:        40.0    Cash + Inv (¥ b):           12.3    5-yr EPS CAGR (11-16):                27.6
            Mkt Val (¥ b):      41.1    Yield (%):       2.74    LT Debt (¥ b):               0.1    4-yr EPS CAGR (11-15):                39.3
            Mkt Val ($ m):     517.2    forex ¥ / $:     80.0    PEG (11/11-15):              1.6    12-month Target Price (¥):           2,400



      Investment Thesis:

      Our Outperform rating is largely based on gain from expected positive news flow on dalcetrapib (JTT- 705, PhIII -US, CETP modulator,
      dyslipidemia). It is a Japan Tobacco Inc. (JTT) candidate which is partnered with Roche for global rights (Ex-JP) and aspiring for ‘first in
      class’ drug for increasing HDL, and carries a multi-billion global potential. Torii being the marketing partner of JTT for pharma in Japan will
      be selling it and is a natural beneficiary of the dalcetrapib success. It is currently under PhII trials in Japan.

      Elvitegravir (JTK 303, filed for combination therapy and PhIII for mono-therapy in US/EU, integrase inhibitor, partnered with Gilead, HIV)
      is next such candidate which will be commercialized in Japan thru Torii (Preparing for registration in Japan).


                                                                                                                                                  32
MP Advisors
CETP Inhibitors at A Glance




                                            33
MP Advisors
CETP Inhibitors at A Glance




                                            34
MP Advisors
DAINIPPON SUMITOMO (4506, ¥820) – PIA
                                                      Latuda Story Is Not Over Yet!
                  Fiscal Year     Total      %      Gross     Op.       %       Op.       EV/      Net       EPS      %      PE     CFPS    PCF
                      (¥ b)       Rev.      Chg.    Margin   Profit   Chg.     Margin    EBITDA   Profit      (¥)    Chg.    (x)     (¥)    (x)
                    03/11 A       379.5     28.1     71.0    30.9     (13.2)    8.1       3.1      16.7      42.0    (20.1) 19.5    (47.0) (17.5)
                    03/12 E       355.6     (6.3)    71.1    23.3     (24.7)    6.5       4.9      13.6      34.2    (18.6) 24.0    (15.4) (53.3)
                    03/13 E       353.8     (0.5)    70.6    34.2     47.1      9.7       4.2      19.2      48.3    41.1    17.0   95.1    8.6
                    03/14 E       343.2     (3.0)    71.6    30.3     (11.3)    8.8       4.6      16.8      42.2    (12.5) 19.4    99.4    8.3
                    03/15 E       321.5     (6.3)    71.7    34.5     13.8      10.7      5.7      19.3      48.5    14.9    16.9   81.1    10.1
                    03/16 E       324.1     0.8      71.5    50.4     45.9      15.5      4.4      28.8      72.3    49.0    11.4   77.4    10.6
                    03/17 E       331.1     2.2      71.6    48.5     (3.8)     14.6      4.5      27.7      69.2    (4.2)   11.9   80.3    10.2

                 SOS (m):           397.9     Dividend:       18.0    Cash + Inv (¥b):          112.2      4 yr EPS CAGR (3/11-3/15):         3.7
                 Mkt Val (¥ b):     326.7     Yield (%):      2.19    LT Debt (¥ b):            133.0      4 yr EPS CAGR (3/12-3/16):        20.6
                 Mkt Val ($ b):       4.1     forex ¥ /$:     80.0    PEG (3/10 / 3/10-3/14):     5.3      12 Month Target (¥):            950.0


   Investment Thesis:
       A number of approaching milestones for its sole catalyst Latuda will unfold positive in the next 6-months and bring additional upside
       that was built following its US approval in Feb-11 and satisfactory Rx uptake thereafter.

   •   Latuda Rx share since launch indicates its acceptability at psychiatrists’ level that faces limitations with the available anti-schizophrenia
       drugs. With its manageable extra-paramedical SEs, impressive metabolic SE profile along with its comparable efficacy to leading drugs
       Zyprexa (Lilly, FY11e US sales ~$2.0b, US pt. ex. Oct-11) and Seroquel (AZN, FY11 WW sales ~$5.7b) is establishing itself as an
       unavoidable switch option for managing schizophrenia. Latuda’s NRx pick up vs. recently launched anti-schizophrenia drugs also
       indicate its better acceptability.
   •   Our PIA now looks ahead to positive outcomes from ‘Bi-polar disorder’ trials, where the opportunity is huge (~1.5x to Schizophrenia in
       value and 2x in growth, chart 2). A number of trials will unfold with their detailed or interim data thru mid-12 and fetch attention.


                                                                                                                                                    35
MP Advisors
LATUDA : Ongoing Clinical Studies




                                                  36
MP Advisors
EISAI (4523, ¥3,060) – Underperform
                                              ‘HAYABUSHA’ Is Difficult To Achieve!
                    Fiscal Year     Total      %      Gross     Op.       %       Op.       EV/        Net       EPS      %      PE     CFPS    PCF
                        (¥ b)       Rev.      Chg.    Margin   Profit   Chg.     Margin    EBITDA     Profit      (¥)    Chg.    (x)     (¥)    (x)
                      03/11 A       768.9     (4.2)    78.2    113.1    31.4      14.7      5.7        67.4      236.5   68.1    12.9   527.9   5.8
                      03/12 E       658.9   (14.3)     73.7    99.6     (12.0)    15.1      6.1        63.5      222.7   (5.8)   13.7   397.0   7.7
                      03/13 E       647.9     (1.7)    74.2    91.4     (8.2)     14.1      6.3        58.1      203.8   (8.5)   14.9   522.8   5.8
                      03/14 E       595.9     (8.0)    73.7    74.0     (19.1)    12.4      7.0        46.6      163.3   (19.9) 18.6    116.1   26.2
                      03/15 E       595.3     (0.1)    74.7    76.3      3.1      12.8      6.8        48.1      168.7    3.3    18.0   213.5   14.3
                      03/16 E       602.1      1.1     74.3    74.7     (2.0)     12.4      6.7        47.1      165.1   (2.1)   18.4   193.8   15.7
                      03/17 E       611.5      1.6     74.5    77.1      3.2      12.6      6.4        48.7      170.7    3.4    17.8   204.0   14.9

                   SOS (m):           285.1     Dividend:      150.0    Cash + Inv (¥b):          180.1        4 yr EPS CAGR (3/11-3/15):       (8.1)
                   Mkt Val (¥ b):     868.2     Yield (%):      4.93    LT Debt (¥ b):            399.9        4 yr EPS CAGR (3/12-3/16):       (7.2)
                   Mkt Val ($ b):     10.85     forex ¥ /$:     80.0    PEG (3/11 / 3/11-3/15):     (1.6)      12 Month Target (¥):             2,500


       Investment Thesis:
       Management’s Mid Term Strategic Plan ‘HAYABUSHA’ embarked from April-11, aims to achieve ¥800b sales and ¥200b OP in 03/16
       (Annexure 1) – which we find too optimistic. We doubt management’s projections of ~20% ROE and find their expectations from Aricept’s line
       extension and new products unrealistic. Eisai revenue is slated to drop following key products patent expiry i.e. Aricept and Aciphex (Pt. exp in
       Nov-10 and May-13 respectively); together they contributed ~¥427b (or ~56% of revenue in FY 03/11). This will lead Eisai’s EPS to fall by ~8%
       CAGR in 03/11-03/15. Though pipeline looks decent and can bring positive surprises, when seen in contrast to expected value built in current
       price Eisai does not appear to be a stock offering good risk-return profile.

   •   Pipeline Potential Overly Built: One of its key candidate, Halaven (eribulin, microtubule growth inhibitor, 3rd line metastasis breast cancer)
       received FDA approval in Nov-10. Following this, Eisai has three late stage candidates – E-2007/ perampanel (Filed, AMPA receptor
       antagonist, epilepsy), E7080/ lenvatinib (PhIII, VEGF receptor, Thyroid cancer) and MORAb-003/ farletuzumab (PhIII, Humanised IgG1 mAb,
       Ovarian cancer) ) –None of these will have enough potential to nullify the loss of Aricept and Aciphex even in their best case scenarios.
   •   Domestic Challenges will Surface Soon: 75%+ FY03/12 revenue is long listed and exposed to price cuts and generics threats. A proposed
       reform for April-12, suggests that premium given for new products developments on some products will be returned, hits Aricept.
                                                                                                                                                        37
MP Advisors
Key Pipeline Candidates
                                                                                                       Exp.
Product              MoA                        Indication                 Market     Stage            Launch

                                                                           US         Filed (2012)     2012

E2007 (perampanel)   AMPA receptor antagonist   Epilepsy                   EU         Filed (May-11)   2012

                                                                           JP         PhII             2013

MORAb-003            Humanised IgG1 mAb         Ovarian cancer             US/EU/JP   PhIII            2013

E7080                VEGF receptor              Thyroid cancer             US/EU/JP   PhIII            2014

                     Microtubule growth
Halaven (E7389)                                 Sarcoma & NSCLC            US/EU      PhIII / II       2015
                     suppressor

E5564 (eritoran)     Endotoxin antagonist       Severe sepsis              US/EU      PhIII            2015

                     Thrombopoietin receptor    Idiopathic
E5501/AKR-501                                                              US         PhII             2015
                     agonist                    thrombocytopenic purpura

                     Thrombin receptor
E5555                                           ACS                        US/EU/JP   PhII             2016
                     antagonist

MORAb-009            Humanised IgG1 mAb         Pancreatic cancer          US         PhII             2016
                                                                                                                38
MP Advisors
RISING STARS - OUTLOOK 2012




Subita Srimal, Ph.D    Khyati Thkrar, M.Sc., PGDBM   Sanjeev Mishra, MBA
subita@mpadvisor.com   khyati@mpadvisor.com          sanjeev@mpadvisor.com
+1.646.657.3794        +1.646.657.3787               +1.646.434.7588




                                                                             39
MP Advisors
• What is Going Right For the sector?

• What Are the Challenges?

• Therapy Areas- Witnessing a Turn Around

• Value creation: Recommendations




  RISING STARS - INNOVATIVE RESEARCH DRIVEN
           UNPROFITABLE COMPANIES
                                            40
MP Advisors
“RIGHT” IN 2011
   •   INCIVEK/ VICTRELIS – HCV - First Protease Inhibitors
   •   Benlysta- Lupus- First Drug after more than two decades –Unmet Need
   •   Yervoy and Zelboraf- mMelanoma- First Drug after more than two
       decades –Unmet Need
   •   Xa Inhibitors- Bleeding, Cardio- Eliquis, Brilinta, Pradaxa, Xarelto- ACS,
       DVT – Better Options than Warfarin (old drug)
   •   Soliris - aHUS - Unmet Need
   •   Jakafi- MPN- first time unmet need
   •   Xalkori- NSCLC- ALK+ve - first personalized drug and diagnostic
       approved together
   •   Adcetris- HL, ALCL - Better Option - More Potent



2011 Was a Tribute to Innovation - New drugs for Unmet Needs/
                First-in-Class were Approved
                                                                                    41
 MP Advisors
Will The Trend Continue in 2012?

•   Drug Launch in Select Therapy Areas
•   Oral RA
•   Genetic Diseases
•   Anti-obesity
•   Cancer
•   Gout
•   Dyslipidemia




                                             42
MP Advisors
SELECT DRUG LAUNCHES: 2012
  Expected Drug Launch From Rising Star Companies
                                                                     Approval/ PDUFA
     Drug                Company             Indication
                                                                          Date
     Bydureon            Amylin              Diabetes type II           28-Jan-12
     Vismodegib          Roche/ Curis        advanced BCC               8-Mar-12
     Peginesatide        Affymax/ Takeda     Anemia in CKD              27-Mar-12
     Qnexa               Vivus               Obesity                    17-Apr-12
     KALYDECO            Vertex Pharma       Cystic Fibrosis           18-Apr-2012
     Contrave            Orexigen / Takeda   Obesity                      1Q12
     UPLYSO              Protalix / Pfizer   Gaucher disease            1-May-12
     Lorcaserin          Arena / Eisai       Obesity                    27-June-12
     Ilaris              Novartis/ REGN      Gouty arthritis              1H12
     HyQ (rHuPH20+ Ig)   Halozyme/ Baxter    Pri immunodeficiency         1H12
     Arcalyst            Regeneron           Gout                       30-Jul-12
     AMR-101             Amarin              MARINE - High           26-July-2012 (T)

     Ridaforolimus       Ariad / Merck       Sarcoma/ Osteosarcoma     8-Aug-12 (T)
     cabozantinib        Exelixis            Medullary thyroid C          2H12
     Kynamro             ISIS/Sanofi         Ho FH                        2H12



MP Advisors
                The Impact Will not Be as Great as in 2011                              43
But…

 Better Drugs For The Patients is not = to the Best Future For the Innovators!




MP Advisors
The Challenges?

•   SALES
•   REIMBURSEMENTS
•   PRICING PRESSURE
•   BETTER DRUGS IN THE MAKING




 Patent Are Essential But do not Guarantee Longevity or Cash Flow




                                                             45
MP Advisors
Innovators Suffered …
 • Devastating in some cases- VRTX, HGSI, DNDN, etc.
 • Reasons were different for each co.- In some cases it was better data
   = shorter life span of innovation- IP may give no protection!
 • Others- High price or ???
 • Most cases – the drop followed approval- Investors are uncertain
   about sales and betting more on “hope” than “reality”?
 • Testing times ahead in 2012 for INCY, REGN, VRTX, AMRN,
   SGEN, HGSI, DNDN etc.
 • So…….?




                                                                      46
MP Advisors
Multiple Options Ahead
•   Choosing between a shining star and profitability!
•   Paradigm shift in investing pattern-: Tap Them Young Or mid-late stage
•   Selective Targeting vs. Pan Drugs – A Dollar ($) war
•   Hope Delivered but Reality bites- GARAGE SALE= Opportunity?
•   Technology Platforms will continue to attract




                                                                             47
MP Advisors
Score Card- 2011
                                 TP      YoY           Hit /
              Companies                        Rating          Comments
                                (LC)   chg (%)        Miss/ Ok
                                                               Initially on robust data in HCV and partnering and
              Pharmasset         NA     441%    NA       H
                                                               later on acquisition
                                                               Current price presents a good investment
                                                               opportunity as catalysts- uptake of Eylea and clinical
              Regeneron          $70     84%    OP       H
                                                               data of its pipeline products will keep the
                                                               momentum in 2012.
                                                               Approval of INCIVEK for HCV and unexpected
                                                               positive data from KALYDECO in cystic fibrosis
              Vertex             $34     62%    OP       H     were the highlights for 1H11. Data from various
                                                               competitive drugs in HCV lead to decline in latter
                                                               part of 2011.
                                                               Drug targets high risk ACS pts and data and
              Anthera            $12    30%     OP       H
                                                               safety so far favors high risk reward opportunity
                                                               Targets niche indication, pivotal trial ongoing.
              *Micromet          $8     23%     OP       H
                                                               Value of tech platform not realised.
                                                               Clinically impressive but may not meet commercial
              AVEO Pharma        $18     19%    MP      Ok
                                                               success due to competition.
                                                               Lack of milestone in 2011. Balanced business model
                                                               of partnered programs and positive cash flow service
              Morphosys          €23      0%    OP      Ok
                                                               segment. Value of tech platform and pipeline should
                                                               unfold in 2012-13.
                                                               Lack of milestones and macro condition pulled the
              ArQule             $7      -1%    OP      Ok
                                                               stock down.
                                                               Solely dependent on the success of fostamatinib and
              Rigel              $8      -3%    MP      Ok
                                                               no milestones in near term.
                                                               Approval of Jakafi for MF did not please the
              Incyte             $18     -6%    OP      Ok     investors as concerns on reimbursement,
                                                               commercial success remain.
                                                               Slow but steady development. Couple of program
              Immunomedics       $6      -8%    OP      Ok
                                                               reached into PhIII.

              * Price as on the day when we initiated the coverage after Outlook'11; PoC = Proof-of-Concept             ………….continued
                                                                                                                        ………….continued
              Dark Red indicates 2011 top picks; Bold are our 2012 Top Picks
              Source: MP Advisors, Company Reports
                                                                                                                                     48
MP Advisors
Score Card- 2011 …continued
                                                              Hit /
                                  TP       YoY
              Companies                          Rating       Miss/   Comments
                                 (LC)    chg (%)
                                                               Ok
                                                                      Pipeline lacks critical mass or catalysts which could
              Galapagos           €8       -12%      MP        Ok
                                                                      move the stock. Return of compounds by GSK
                                                                      Promising PhIIb data but the delays in start of PhIII
              Ardea Biosci.       $28      -20%      OP        Ok     and no partnership announcement lead to decline in
                                                                      2H11.
              ISIS                $8       -27%      MP        M       No milestones or new prog to drive the company.
                                                                      Question over the patent life of key drug
              *Amarin             $8       -55%      MP        M
                                                                      overshadows the advantages of marketed options.
                                                                      Though PhIIb of HCV compounds data were
              *Medivir          SEK59      -49%      MP        M      positive, change in management, increasing
                                                                      competition in HCV lead to the decline.
              MXUS0HC                     4.6%                        MSCI USA/Health Care
              MXUS0PB                     -0.4%                       MSCI US Pharma & Biotech
              * Price as on the day when we initiated the coverage after Outlook'11; PoC = Proof-of-Concept
              Dark Red indicates 2011 top picks; Bold are our 2012 Top Picks
              Source: MP Advisors, Company Reports




                                                                                                                              49
MP Advisors
RS- Recommendations for 2012

•   MITI (acq. By AMGN)
•   INCY
•   VRTX
•   REGN




                                             50
MP Advisors
Focus on Therapy Areas in 2012
 •   Last year was most eventful for HCV, Melanoma, Lupus and Anti Coagulants.
 •   Exciting Data, Approvals, Spectacular Launch and Astounding Acquisitions! GILD-VRUS
 •   This Year Also Started with a Bang for HCV- BMS-INHIBITEX acquisition
 •   Data in HCV “oral IFN free combinations” will decide the wisdom of the “Premium Paid”.
 •   2012- A year to Remember for Alzheimer's – Key PhIII drug data –Make or Break
 •   More oral options in MS and First in RA
 •   Cancer Vaccines- DNDN rose from the graves in 2012 with good sales. Data from other Cancer
     vaccines will decide whether its “Hope or Hype”
 •   Anti obesity drugs may finally see the light – though with a Narrow Label.
 •   Biosimilars/Better Biologics- Regulatory Pathway- an Evergreen area of interest.




                                                                                                  51
MP Advisors
Garage Sale-Tech Focus
 •   ALNY
 •   ABLX
 •   ICLL
 •   IMMU
 •   DVAX
 •   IDRA
 •   VNDA




              Many Trading Close at Their Cash Value!


                                                        52
MP Advisors
MATURE BIOTECH –WATCH OUT
                 FOR….

 • VALUATIONS
 • SALES/EARNINGS EXPECTATIONS
 • GENERIC THREAT




              “Only Green – No Red” – Entering 2012 with High Expectations

                                                                             53
MP Advisors
Score Card- 2011
                                                              Hit / Miss/
      Companies                 Target Price   YoY chg. (%)                 Comments
                                                                  Ok


                                                                            World wide sales growth of Soliris in PNH and label expansion. Focus on
      Alexion                       $75            74%            H         orphan and rare diseases make it most eligible of an acquisition target after
                                                                            Genzyme.



                                                                            Increased focus on MS therapy area. Volume growth of Tysabri and sales
      Biogen Idec                   $60            69%            H         growth of Avonex (due to price increase) along with unexpected positive PhIII
                                                                            data from BG-12, an oral MS drug, took the stock to a new high



                                                                            Settlement with Bayer for regorafenib and acquisition rumor. FDA decision of
      Onyx Pharma                   $35            32%            H         not granting priority review in Dec ‘11 for Carfilzomib’s hampered the positive
                                                                            sentiment of investors.



                                                                            Revlimid’s malignancy related issue and generic threat from Natco Pharma
      Celgene                       $72            9%             H         overweigh the sales ramp up + Japan launch of Revlimid and positive pipeline
                                                                            news flow.


                                                                            Share repurchases, dividend payments and denosumab ramp-up hedges the
      Amgen Inc                     $63            9%             H
                                                                            sales decline of ESA franchise- and blankness of pipeline.



                                                                            Did not perform as expected due to maturing sales growth from HIV franchise
                                                                            and lately announcement of VRUS’ acquisition news; however, we see it as a
      Gilead Sci.                   $45            6%            Ok
                                                                            perfect move to gain the leadership position in HCV market using its vast
                                                                            experience in anti-viral therapy.

                                                                                                                                                              54
MP Advisors         Bold are MP’s 2012 Top Picks
VALUATION SNAPSHOT
            NPV of    NPV of                Cash &         Part A                                                             Part
                                  Value of                                                                         Mkt
             Mkt     Late Stage              Other Price**    to                                                            A+B+C+
   Company                      Intangibles                                                                        Cap
           Products Pipeline                 Cash    ($)   Price**                                                         Net Cash to
                                 (Part C)*                                                                         ($m)
           (Part A)* (Part B)*              Flows*          (%)                                                             Mkt Cap
   Gilead#              44.6              10.2                 6.7             (13.0)           40.2         111% 31,286     121%
   Celgene              60.0              6.3                  9.8              (3.7)           61.3          98% 28,174     118%
   Biogen
                        96.1              16.3                21.6              (4.1)          111.8         86% 27,429      116%
   Idec
   Alexion              51.7              9.7                 17.3              (3.4)           65.1         79% 12,622      116%
   Amgen                70.3              1.4                 2.0              (11.7)           57.5         122% 47,668     108%
   Onyx                 15.2              22.2                9.2               (2.8)           44.0         34% 2,796       100%
* $/share; ** as on 12/05/2011; # including impact of Pharmasset acquisition; Bold are MP’s 2012 Top Picks
Source: MP Advisors, Company Reports




                                                                                                                                   55
MP Advisors
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012
Global Pharmaceutical and Biotechnology Outlook 2012

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Global Pharmaceutical and Biotechnology Outlook 2012

  • 1. GLOBAL BIOPHARMA OUTLOOK 2012
  • 2. LARGE-CAP PHARMA Vishal Manchanda, B.E., MBA vishal@mpadvisor.com Ripple Mehta, B.Pharm, MBA ripple@mpadvisor.com Vijayakannan, PhD vijay@mpadvisor.com +1.646.657.3787
  • 3. Outlook - 2012 • Patent Cliff - ~ $50b of patented sales to be genericised – AZN, PFE, NVS, SAN, BMY, LLY to bear the pain • Innovation to foster growth in several therapeutic areas – HCV – Metastatic Melanoma – New Generation Oral Anti-coagulants – Alzheimers – Multiple Sclerosis – GLP-1’s therapy areas • Patent Expiry and Pricing Pressures will intensify M&A activity • LLY, AZN, and BMY would go for deals to fuel their topline 3 MP Advisors
  • 4. Patent Expiry Pressures will be at its Peak 2011 Products Sales going off patent Cum ve ulati Sales in$m Cum veulati C pany om Sales Erosion (2011) 2011 2012 2013 2014 2015 2016 Company Sales Erosion 11-16 as %of 11-16 ($b) 2011 R evenues LLY 22,225 4,637 6,345 1,069 302 LLY 12,353 56% N O OV 11,831 3,842 914 NO VO 4,756 40% AZN 31,711 1,191 5,725 995 7,538 6,539 AZN 21,988 69% PFE 57,522 13,556 4,317 1,171 2,877 1,268 350 PFE 23,539 41% BM Y 21,398 8,200 1,434 3,908 689 BM Y 14,231 67% SAN 38,286 264 6,845 232 5,632 637 SA N 13,610 36% NVS 48,565 923 8,188 2,703 922 5,665 NV S 18,401 38% M RK 41,018 6,295 1,368 1,670 1,905 407 M RK 11,645 28% GSK 43,328 9,154 589 1,179 GSK 10,922 25% RO G 44,735 1,485 747 649 ROG 2,881 6% Total ($) 360619 22056 49471 14837 23550 16125 8287 134326 37% With growth in Western Markets Crumbling to Patent Expiry Pressures, Will Emerging Markets offer some respite?? 4 MP Advisors
  • 5. Emerging Market – An Oasis or just a Mirage? • China, so far has been the pillar of Emerging Market Growth for Large Pharma, but it is also giving away to policy pressures – The EDL is expected to double in size, putting pressure on MNC growth – Reimbursement norms to be tightened – Price cuts • Global recessionary pressures have put Emerging market growth forecasts down and should impact the pace of healthcare spending A Select few Large Cap Companies are immune to these pressures and also offer the promise for growth 5 MP Advisors
  • 6. Our Top and Bottom Picks in the Large Cap Space for 2012 Top Picks • Roche • GlaxoSmithKline Bottom Pick • Bristol-Myers Squibb 6 MP Advisors
  • 7. Strong double digit EPS growth together with +ve news-flow on late stage pipeline will put Roche back in flavor Positive clinical data on T-DM1 and approval of Pertuzumab will ease concerns related to patent expiry HERA study exploring 2 year adjuvant use of Herceptin versus 1 year Adjuvant use Interim Analysis from DAL-OUTCOME Study, if positive will lead to a run up in the stock price much above our PT of CHF 180 Avastin may add a couple of more indications – Ovarian Cancer, while we will see pivotal data on first line Glioblastoma multiforme, triple negative breast cancer and Treatment through multiple lines in colorectal cancer. The late stage trials are supported by clinical evidence Head to Head study comparing Actemra to Humira – Cross trial comparison suggests non- inferior outcome 7 MP Advisors
  • 8. GlaxoSmithKline – Upgrade to Outperform We anticipate positive data on its Oncology and Respiratory pipeline, which should lead to a revision in long term growth forecasts for GlaxoSmithKline On Tykerb, ALTTO study exploring Tykerb in combination with Herceptin in Adjuvant use in breast cancer will report data and we expect a positive outcome – The indication will add £1b pound in peak sales GSK’s melanoma pipeline (BRAF inhibitor, MEK inhibitor) is best in class and we will see PhIII data On the respiratory pipeline, we expect a positive outcome from a host of studies exploring Relovair and LABA/LAMA FDC in PhIII trials In the rare disease Pipeline Migalastat for Fabry disease is promising and looks better than available treatment options (Repligal and Fabrazyme). Head to head study comparing Migalastat with Repligal and Fabrazyme should also reveal data 8 MP Advisors
  • 9. Bristol-Myers – Bottom Pick Valuations are rich, patent expiry pressures are peaking and pipeline expectations build in more than a bull case We see restricted uptake of Eliquis as we believe Eliquis label in SPAF will be no better than other approved anticoagulants. Patients adequately controlled on warfarin are unlikely to switch as twice daily dosing will be a dampener Yeryoy ramp up has been impressive, but the sales will soon plateau as competitors will enter and physician will be discouraged to use Yer yoy owing to serious side effects and very low response rate. European uptake will be very slow due to reimbursement hurdles 9 MP Advisors
  • 10. Japan Pharma 2012 日本の製薬会社 Summary Of Japan Section From ‘Global Bio-Pharmaceutical Outlook-2012’ Bio- Outlook- 2012’ Top Picks : Chugai, Daiichi Sankyo, Torii, Towa Pos. Invest. Alert: Dainippon Sumitomo Bottom Pick : Eisai Devesh Singh, Pharmacist, MBA Vrunda Shah, CFA, MS (Fin) devesh@mpadvisor.com vrunda@mpadvisor.com +1.646.657.1016 +1.646.657.1016 ! 10 MP Advisors !
  • 11. Key Take Away • Drivers to promote generics are likely to intensify generics pick up from April 2012. • 2012 price cuts least affecting foreign cos, while Japanese cos are more exposed largely due higher contribution of long-listed drugs and variation in innovations premium. • Generic growth is inevitable; even after rapid penetration, huge untapped opportunity exists for generic companies. • Innovation will continue to drive growth of Japanese majors while only a few promise positive news flow in next 1-2 years. • Major Japanese's innovators are not targeting generic opportunities – their focus remains on – innovation & going global. But this trend could change in near future. • Hybrid pharma began from 2010; and will start playing major role in reshaping Japanese pharma soon. Daiichi Sankyo currently is the only company in Japan in hybrid pharma. • Consolidation activities in Japan generic will spur: foreign/ non-generic companies have started taking japan generic as one of the growth drivers. • Japanese majors have poured massive ~$50b in acquiring innovation – next 2-3 years will unfold their success potential. • Majority of Japanese pharma cos still struggling with patent expiries; in next 3 years more than ¥900b drugs going to expire. • Despite several odds, Japan pharma offers opportunities for both long & short term investors. 11 MP Advisors
  • 12. Coverage & Top-Picks Market EPS 4yr ROE ROCE EV/EBI Company Rating Price SOS Cap. EV-12 CAGR P/E-12 TP 03/12 03/12 TDA ( ¥b) (11-15) Daiichi Sankyo Outperform 1562 709.0 1107.5 1089.1 4.9 2.3% 10.3% 16.0 5.3 1850 Dainippon Pos. Inv Alert 1141 335.1 382.3 346.8 1050 5.8 7.0% 9.1% 16.5 6.4 Sumitomo Eisai Underperform 870 397.9 346.2 341.3 5.5 6.3% 6.6% 32.2 5.2 950 Takeda Market Perform 3365 285.1 959.4 1033.3 (9.1) 11.6% 11.5% 17.1 6.7 2500 Astellas Market Perform 3770 789.4 2975.9 3345.7 (11.0) 5.8% 8.8% 23.5 7.5 3500 Shionogi Market Perform 3435 470.0 1614.5 1373.1 8.4 7.1% 11.6% 22.9 6.6 3200 Global 6.7% 9.6% 21.4 6.3 Chugai Outperform 1474 544.8 803.0 625.4 11.2 10.8% 15.1% 15.6 6.2 1700 Mitsubishi Tanabe Market Perform 1152 561.4 646.7 511.5 5.4 5.4% 8.5% 16.4 5.6 1350 Kyowa Hakko Market Perform 882 576.5 508.5 428.5 3.5 5.0% 7.7% 16.9 5.3 950 Kyorin Market Perform 1570 74.9 117.6 90.4 0.5 8.7% 12.0% 11.1 4.9 1500 Domestic 7% 11% 15.0 5.5 Towa Outperform 3790 17.2 65.1 71.1 5.4 12.6% 14.7% 10.7 5.5 4100 Sawai Market Perform 8660 15.7 136.0 143.7 10.9 14.1% 14.9% 14.0 7.9 8200 Nichi-Iko Market Perform 1832 30.9 56.6 68.5 12.6 17.2% 22.5% 10.6 6.1 NA Nippon Chemiphar Market Perform 495 38.2 18.9 25.7 36.0 7.9% 10.6% 12.9 7.4 320 Generic 13% 16% 12.1 6.7 Average 9.0% 12.0% 16.1 6.2 Price as on 23rd March, 2012 Source: MP Advisors; Company Reports Opportunities Exist For Both Long & Short Term Investors 12 MP Advisors
  • 13. Segments Specific ‘Key Success Factors’ Segment Key Success Factors Top/Bottom Picks Innovators Domestic focused Low % sale coming from long listed products Late stage R&D – own as well as in-licensed. Chugai, Internationalization capabilities Torii Willingness to consolidate Strong marketing abilities in Japan such that it improves the chances of licensing-in good products Global Higher overseas exposure Daiichi Sankyo, Lower long listed drugs contribution Eisai Rich PhIII pipeline Generics GP1/DP2 Strong marketing infrastructure with sales force and rapport with GP / DP Oral formulations etc. Towa 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 Source: MP Advisors JP Specific Drivers Will Continue To determine Success 13 MP Advisors
  • 14. Japan Pharma – Market Model Mar-11 Mar-12 Mar-13 Mar-14 Mar-15 Mar-16 Mar-17 Mar-18 Mar-19 Mar-20 Total Rx Market 7,802 8,036 8,277 8,526 8,781 9,045 9,316 9,596 9,883 10,180 Every year new patent % Change 3.0% 3.0% 3.0% 3.0% 3.0% 3.0% 3.0% 3.0% 3.0% 3.0% expiries keep on New pt Exp. (¥b) 294.0 387.5 331.9 341.7 195.0 466.0 443.0 522.0 400.0 450.0 increasing potential Total Long Listed Products Price Adj 3,358.6 3,712.5 3,970.1 4,272.1 4,125.4 4,550.1 4,629.1 5,104.8 5,096.4 5,495.5 target market for Long Listed drugas as % of Total DO Market 43% 46% 48% 50% 47% 50% 50% 53% 52% 54% generic cos. This leads TOTAL Market Available for Generics 3,359 3,713 3,970 4,272 4,125 4,550 4,629 5,105 5,096 5,495 to higher generic Hospital Market (DPC Affiliates ) opportunity despite No of DPC Hospitals 1393 1452 1496 1525 1556 1587 1619 1651 1684 1718 robust generic growth. # of beds in DPC hospt. In Japan ('000) 494 504 514 524 534 545 556 567 578 590 Total # of beds in Japan ('000) 913 913 913 913 913 913 913 913 913 913 % of total beds in Japan 54% 55% 56% 57% 59% 60% 61% 62% 63% 65% % of total beds in Japan 47% 48% 49% 49% 50% 50% 51% 51% 52% 52% % Change 2% 2% 2% 1% 1% 1% 1% 1% 1% 1% Total NRx generated as % of Total Market 37% 38% 38% 39% 39% 39% 40% 40% 41% 41% Total DPC Market size (available for generics) 1235 1393 1519 1651 1611 1794 1844 2053 2070 2255 Drivers of Generics use Increase in DPC Cost saving measures 10% 10% 13% 14% 17% 17% 20% 20% 23% 25% hospitals will be a Due to Co-payment 3% 3% 3% 3% 3% 3% 3% 3% 3% 3% largest Generic growth Others factors 2% 2% 3% 2% 6% 6% 7% 5% 7% 4% catalyst in future. Consolidate impact of all Drivers 15% 15% 19% 19% 26% 26% 30% 28% 33% 32% Total Generics Sales at DPC Hospitals 185.3 208.9 288.7 313.8 418.8 466.5 553.1 574.9 683.3 721.6 % Change 10% 13% 38% 9% 33% 11% 19% 4% 19% 6% DPC Hospt Generics Sales as % of Total sales 2.4% 2.6% 3.5% 3.7% 4.8% 5.2% 5.9% 6.0% 6.9% 7.1% 15% 15% 19% 19% 26% 26% 30% 28% 33% 32% Various growth catalyst Non-DPC Market together boost Generics Total Non-DPC Market (GPs/Clinics/small hopt/ 2,123 2,320 2,451 2,621 2,515 2,756 2,786 3,051 3,026 3,241 penetration. Total GP's/dipensing/clinics Market 516.6 598.0 717.6 803.7 932.3 1034.9 1210.8 1356.1 1559.5 1715.5 % Change due to Reforms/ Drivers 22.5% 15.8% 20.0% 12.0% 16.0% 11.0% 17.0% 12% 15% 10% % of total Non-DPC generic market 24% 26% 29% 31% 37% 38% 43% 44% 52% 53% % of Total Rx market 6.6% 7.4% 8.7% 9.4% 10.6% 11.4% 13.0% 14.1% 15.8% 16.9% Years from FY 03/12 0 1 2 3 4 5 6 7 8 Total Generic market (by value in ¥b) 702.0 807.0 1006.3 1117.5 1351.1 1501.4 1763.9 1931.1 2242.8 2437.1 Despite high growth, % change 19.0% 15.0% 24.7% 11.0% 20.9% 11.1% 17.5% 9.5% 16.1% 8.7% penetration will remain Generics as % of Total Market 9.0% 10.0% 12.2% 13.1% 15.4% 16.6% 18.9% 20.1% 22.7% 23.9% as low as <12% (by 15 val) in GP/DP market GP/DP to DPC Market Share Ratio 1.7 1.7 1.6 1.6 1.6 1.5 1.5 1.5 1.5 1.4 by 2016. 14 MP Advisors Despite Rapid Penetration, Huge Untapped Opportunity Exists for Generic Companies
  • 15. Major Japanese M&A in Last 4 Yrs Premium to Acquired Acquisition Cash paid Company 3m. Avg Company date ($b) price. (%) Takeda Nycomed 19-May-11 13.50 NA Takeda Millennium 10-Apr-08 11.00 71.00 Daiichi Sankyo Ranbaxy 11-Jun-08 4.60 50.00 Astellas OSI 17-May-10 4.00 55.00 Eisai MGI 10-Dec-07 3.90 37.48 Dainippon Sumitomo Sepracor 3-Sep-09 2.60 37.86 Shionogi Sciele 1-Sep-08 1.42 57.55 Daiichi Sankyo Plexxikon 28-Feb-11 0.80 NA Hisamitsu Noven 14-Jul-09 0.43 43.00 Taisho Pharma BMY’s Units 16-Sep-09 0.31 NA Eisai AkaRx Inc 18-Dec-09 0.26 NA Nipro Pharma Home Diag. 17-Mar-10 0.18 NA Total Cash Paid 43.00 Source: MP Advisors; Company Reports Massive Money Poured Overseas Remain Questionable For Most - Takeda Biggest Looser! 15 MP Advisors
  • 16. Average Price Cuts And Reforms 2012 Yakka-Sa vs. Price Cuts Price Cuts Came As Expected: 25.0 23.1 • ~6% overall and Additional price cut for 20.0 off-patent brands 17.8 15.0 % Value 14.5 13.1 • Premium for New Drug Development 8.4 will continue in 2012 reforms 10.0 9.7 9.5 6.7 8.4 6.6 6.8 7.0 7.1 6.9 6.3 6.3 5.8 5.0 6.5 5.2 4.4 6.2 • Lower price cuts for Original Drugs 4.2 0.0 2012 E 1992 A 1994 A 1996 A 1998 A 2000 A 2002 A 2004 A 2006 A 2008 A 2010 A • High Yakka-sa for Vasodolators (11.6%), Peptic ulcer drugs (10.8%) and Anti- Year allergic drugs (10.5%) Price Cuts Yakka Sa • Foreign cons are least affacted while Source: MP Advisors; MHLW Eisai is most affacted with >11% price cuts 16 MP Advisors
  • 17. Average Price Cuts in 2012 Source: MP Advisors; MHLW MP Advisors Foreign Cos are least affected while Eisai is most affected co. 17
  • 18. Long Listed Exposure vs. Overseas Sales 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 47.79 53.24 52.54 46.83 42.63 35.14 Astellas Overseas Sales % 46.77 45.77 43.49 42.08 39.14 39.66 38.70 39.96 41.93 44.40 Long L As % of DO Sales 32.12 26.80 18.51 22.11 23.93 19.41 16.01 13.34 11.11 9.39 Chugai Overseas Sales % 9.72 9.70 6.25 7.99 10.92 13.49 14.02 14.16 13.83 13.91 Long L As % of DO Sales 28.98 31.81 47.26 52.22 46.35 41.66 37.43 35.14 33.19 Daiichi Sankyo Overseas Sales % 38.6 44.7 50.4 49.4 46.1 49.7 48.2 51.6 53.1 Long L As % of DO Sales 43.13 41.04 71.73 70.01 63.92 61.47 57.93 61.98 58.83 55.54 Dainippon Sumitomo Overseas Sales % 7.31 7.99 7.27 17.80 40.11 36.04 36.38 33.98 29.44 29.35 Long L As % of DO Sales 28.02 26.21 28.69 27.95 42.81 72.55 67.69 65.62 60.16 55.53 Eisai Overseas Sales % 57.30 58.53 64.26 61.56 54.4 44.7 48.1 47.4 49.7 52.0 Long L As % of DO Sales 41.40 39.32 32.81 29.93 29.09 28.15 26.61 25.27 24.01 22.80 Kyorin Overseas Sales % 4.15 3.70 2.75 2.38 2.19 2.00 1.85 1.80 1.67 1.55 Long L As % of DO Sales 68.05 65.11 64.89 71.78 42.79 35.69 38.53 49.22 73.68 46.28 Kyowa Hakko Kirin Overseas Sales % 3.44 4.16 6.32 4.89 5.8 9.4 12.8 13.2 13.6 14.0 Long L As % of DO Sales 65.11 60.68 60.93 58.27 60.03 56.58 55.15 52.34 66.31 67.45 Mitsubishi Tanabe Overseas Sales % 5.81 6.10 5.65 5.20 5.29 5.87 6.32 6.65 6.80 6.57 Long L As % of DO Sales 44.85 39.67 49.65 42.22 38.13 33.38 29.55 25.97 26.68 23.55 Shionogi Overseas Sales % 14.44 15.81 24.65 36.33 36.5 31.0 27.2 25.0 25.0 26.0 Long L As % of DO Sales 14.93 19.31 19.55 23.00 32.91 30.44 37.65 36.43 53.33 52.08 Takeda Overseas Sales % 33.82 49.69 54.86 53.24 49.17 51.26 50.60 50.24 51.04 53.36 Source: MP Advisors; Company Reports Global Cos Increasing Dependence on Domestic Markets + Long Listed Products Makes them Vulnerable to Healthcare Reforms 18 MP Advisors
  • 19. Reforms Promoting Both Generic Penetration and Innovation Reforms That Will Increase The Use Of Generic Drugs Near term impact (0-2 years) Long term impact (>2yrs+) • Higher Dispensing Fee • Patients Co-payment • Prescription Using Generic Name • Freedom To Stock One Generic Brand • DPC Expansion • DPC For Out-patients • Incentive To Physicians • Free Pricing For Generic Drug • Mandatory Approval Of All Strengths • Incentive To Pharmacies For Generics Drugs Availability Reforms That Will Foster Innovation Near term impact (0-2 years) Long term impact (>2yrs+) Reforms That Will Foster Innovation • Increased Number Of Reviewers • Cost Based Pricing • Better Clinical Trials Infrastructure & Support • No Price Cuts During Patent Period • Free pricing of all drugs Source: MP Advisors; MHLW 19 MP Advisors
  • 20. Reforms to be Implemented From April 2012 Reform Description Impact Biggest Beneficiary Companies Premium for generics dispensing Further increase in incentive for pharmacist; likely to be Higher generic substitution at dispensing pharmacy in pocket of those who dispensed more than 30% of Sawai, Towa, Nichi-Iko generic Higher bonus points to Hospitals for more Awarding higher bonus point to hospitals using atleast More Rx on generic drugs to generate to get more usage of generics 30% generics (35 points); Hospital using atleast 20% bonus points awarded points reduced from 30 to 28 points. Sawai, Nichi-Iko Higher discount to new generic launch First generic version set to be min 40% discount to Increasing discount will make generic drugs more branded drug instead of current 30% discount. competitive against long listed drugs All generic companies Reducing the difference in price of Currently there is huge price difference between the two Reducing the gap at lower end will make generic dugs Generic drugs brands of generics. more competitive to long listed as well as among Towa, Sawai, Nichi-Iko generic drugs. Change in Rx-format Removal of ‘no substitution permitted’ column from Increase generic substitution at pharmacy current Rx format and compulsory writing the generic name of the drug. All generic companies Increase in management and guidance fee Points awarded to pharmacies for providing drug history More Rx on generic drugs to generate management and guidance will rise to 41 points, from 30 points at present All generic companies Abolition of premium for GE dispensing The abolition of the extra two points awarded to Impact negatively to the sales of newly listed generic Source: MP Advisors; MHLW and GE information provision fee pharmacies for dispensing generic drugs and the 15 points drugs for providing drug information All generic companies 20 MP Advisors
  • 21. Revised Incentives For Pharmacies Revised Incentive for Pharmacies Old Generic Rx by Volume 0% - 19% 20%-24% 25%-29% >=30% Before April 2010 Incentives for Pharmacy / NA NA NA ¥40 Patient From April 2010 NA ¥60 ¥130 ¥170 New Effective from (April Generic Rx by Volume 0% - 21% 22%-29% 30%-34% >=35% 2012) Incentives for Pharmacy / NA ¥50 ¥150 ¥190 Patient Difference ¥10 ¥20 ¥20 Source: MP Advisors; Company Reports Generics Investment Thesis: • Increase in incentives for pharmacies has led to a spur in generic sales (~22% increase in FY 03/11) • Pharmacies which currently falls under 25%-29% slab will be encourage to boost their generic uptake to at least 30% to avail higher bonus points. Revised Incentives Will Boost Generics Uptake To New Level 21 MP Advisors
  • 22. Segment Specific ‘Key Success Factors’ Lupin Self/Agencies • All generic companies position Towa themselves into two broad segments and distribution channels M. Sawai Tana be • For Generics, Marketing/Branding Nichi capabilities in GP/Dispensing pharma DPC Iko market, and distribution capabilities Nippo n GP/Dispensing into DPC/large hospitals segment will Kyorin Chemi Pharma phar determine success. Meiji DSE Elmed N. • Near term opportunity lies in Kayaku GP/Dispensing Pharma segments, and Towa & Sawai appeared best positioned to leverage benefits from pro-generic reforms. Wholesalers Positioning of Japanese generics Cos* *Illustrative only Source: MP Advisors, Company Reports 22 MP Advisors
  • 23. Approaching Generic Opportunities in Next 3 Years FY 03/11 Sales Product Generic name Marketed by in ¥b 2012 Leuplin leuprorelin acetate Takeda 64.3 Nu-lotan losartan MSD 40.08 Paxil Paroxetine GSK 39.35 TS-1 NA Taiho 38.31 Myslee Zolpidem Astellas 31.69 Allelock olopatadine hydrochlorid Kyowa Hakko Kirin 29.23 Seroquel quetiapine Astellas 25.7 Gasmotin mosapride citrate Dainippon Sumitomo 20.06 Arimidex anastrozole AstraZeneca 19.23 Norditropin somatropin(genetical recoNovo Nordisk 17.66 Lantus INSULIN GLARGINE Sanofi Aventis 12.17 Humalog Insulin Lispro Eli Lilly 12.15 Funguard micafungin sodium Astellas 12.11 Total Key Products Expiry in 2012 362.03 2013 Diovan valsartan Novartis 110.59 Remicade infliximab Mitsubishi Tanabe 63.25 Livalo Pitavastatin Kowa 31.54 Loxonin Tape loxoprofen Daiichi Sankyo 22.02 Valtrex Valaciclovir GSK 19.37 Ceredist taltireline Mitsubishi Tanabe 18 Zithromac azithromycin Pfizer 15.29 Taxol paclitaxel Bristol 13.88 Flolan Epoprostenol GSK 11.11 Total Key Products Expiry in 2013 305.06 2014 Blopress Candesartan Takeda 119.93 Allegra fexofenadine Sanofi Aventis 48.66 Glivec imatinib Novartis 38.09 Rituxan Rituxicimab Chugai 24.69 BI Sifrol NA Boehringer 13.1 Oxarol maxacalcitol Chugai 13.06 Mearubik measles & rubella vaccineMitsubishi Tanabe 12.46 Source: MP Advisors Claritin Loratadine Shionogi 10.16 Total Key Products Expiry in 2014 280.14 23 MP Advisors Total Key Products Expiries in next three years 947.23
  • 24. Foreign Companies Entry In Japan Generic Market Foreign Domestic Company Year Comment Company Sandoz Nippon Hexal 2006 First to launch generic recombinant in 2009 Hospira Taiya Yakuhin 2006 Developed injectable generics Lupin Kyowa Pharma 2007 Lupin acquired majority stake in Kyowa pharmaceuticals industries Zydus Nippon Universal 2007 Launched Zydus Pharma Inc. in 2006 and stared Pharma operation with acquisition of Nippon Universal Pharma in 2007 Mylan – 2008 Acquired generic business of Merck Ranbaxy Daiichi Sankyo 2008 Daiichi acquired Ranbaxy Teva Kowa Pharma 2009 Established joint venture GSK JCR Pharma 2009 Signed agreement with GSK for manufacturing Bio-similar, launched generic EPO in Japan Actavis Aska Pharma 2009 Established joint venture PharmaForce Luitpold (Daiichi Sankyo) 2010 Daiichi Sankyo subsidiary acquired PharmaForce, a generic injectable maker in US Sanofi-Aventis Nichi-Iko Pharma 2010 Established joint venture Teva Taiho Pharma 2011 Teva acquired majority stake in Taiho Pharma Dr. Reddy’s Fuji Film 2011 JV announced. Fuji is new in pharma business Lupin India I’rome 2011 Acquired. I’rome has Injectables facility Source: MP Advisors, Company Reports Expect More Consolidation Activities in Coming Days! 24 MP Advisors
  • 25. Investment Ideas -2012 Outperforms : Chugai Daiichi-Sankyo Torii Towa PIA: Dainippon Sumitomo Underperform: Eisai 25 MP Advisors
  • 26. CHUGAI (4519, ¥1,237) – Outperform 2012 Going to Be Happening! Fiscal Year Total % Gross Op. % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Margin Profit Chg. Margin EBITDA Profit (¥) Chg. (x) (¥) (x) 2010 A 379.5 (11.5) 57.20 66.2 (19.7) 17.4 6.0 41.4 75.9 (26.1) 16.4 (11.8) (105) 2011 E 394.2 3.9 57.98 71.9 8.7 18.2 5.6 43.6 80.0 5.4 15.5 111.8 11.1 2012 E 416.6 5.7 58.65 82.2 14.4 19.7 4.9 51.6 94.7 18.4 13.1 76.3 16.3 2013 E 430.9 3.4 59.22 88.2 7.3 20.5 4.6 55.5 102.0 7.6 12.2 89.9 13.8 2014 E 449.2 4.2 60.10 100.0 13.4 22.3 4.1 63.2 116.0 13.8 10.7 101.5 12.2 2015 E 471.4 4.9 61.22 115.6 15.6 24.5 3.6 73.3 134.5 15.9 9.2 117.6 10.6 2016 E 498.1 5.7 62.56 135.6 17.3 27.2 3.2 86.1 158.0 17.5 7.9 138.4 9.0 SOS (m): 544.8 Dividend: 40.0 Cash + Inv (¥b): 160.9 4 yr EPS CAGR (12/10-12/14): 11.2 Mkt Val (¥ b): 677.2 Yield (%): 3.22 LT Debt (¥ b): 0.0 4 yr EPS CAGR (12/11-12/15): 13.9 Mkt Val ($ b): 7.96 forex ¥ /$: 80.0 PEG (2011/2011-2015) 1.41 12 Month Target (¥): ¥ 1,500 Investment Thesis: 2012 will unfold a number of important catalysts and bring upside to this ‘least risk carrying company’ of Japan – these are – 1. Data that will claim Actemra’s label expansion and its likely filing for 1st line RA in the US 2. Positive news flow from Roche’s multinational studies, especially around its growing breast cancer franchise i.e. pertuzumab and T-DM1 and their filings in Japan 3. Safe domestic business and sales ramp up of newly launched products in Japan - Mircera (approved April-11, peak sales pot. ¥40b) and Edirol (launch April-11, peak sales pot. ¥15b), and 4. A likely increase of Roche’s stake in Chugai as the basic agreement that prevented Roche from increasing its stake will expire in Oct-12. 26 MP Advisors
  • 27. Upcoming Milestones Price Impact Period Year If Expect Drug Event Description If Neg ation Posi ativ tive e Clinical Head to Head study vs. Actemra 1Q 2012 High Med Positive data Humira (ADACTA study) PhIII data from overseas Clinical T-DM1 EMILIA study 2nd line HER 1H 2012 Low Low Neutral data 2+ BC Metastatic breast cancer HER T-DM1 US filing 2+ second-line based on 1H 2012 High Low Neutral EMILIA study Corporate Roche may increase its stake NA Oct 2012 High Low Positive event in Chugai US approval in mBC HER2+ US Pertuzumab firstline based on PFS data 2H 2012 High Low Positive approval with Herceptin Pertuzumab JP Filing As adjuvant to Herceptin 2H 2012 Med High Positive Actemra US filing DMARD IR first line filing 2H 2012 Low low positive Actemra US filing For SC formulations 2H 2012 High High Positive Tarceva JP Filing Filing for 1st line NSCLC 2H 2012 Med Med Positive Clinical SC vs. IV (SUMMACTA Any Actemra 2012 Low Low Positive data PhIII study) time T-DM1 JP Filing JP filing 1H 2013 Med Med Positive Source: MP Advisors, Company Reports 27 MP Advisors
  • 28. DAIICHI SANKYO (4568, ¥1,466) – Outperform ‘Hybrid Tree’ Is Ready to Give Fruits! Fiscal Year Total % Gross Op. % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Margin Profit Chg. Margin EBITDA Profit (¥) Chg. (x) (¥) (x) MAR-11 A 967.5 1.6 70.9 122.3 28.1 12.6 5.4 70.3 99.2 68.0 14.8 158.6 9.2 MAR-12 E 945.4 (2.3) 71.1 114.8 (6.1) 12.1 5.4 20.5 29.0 -70.8 50.6 19.5 75.3 MAR-13 E 1,009.4 6.8 70.6 127.6 11.2 12.6 5.0 69.1 97.4 236.5 15.0 74.0 19.8 MAR-14 E 1,095.2 8.5 70.8 141.7 11.1 12.9 4.7 80.8 114.0 17.0 12.9 126.7 11.6 MAR-15 E 1,133.9 3.5 70.7 150.2 5.9 13.2 4.6 85.1 120.0 5.3 12.2 146.8 10.0 MAR-16 E 1,190.5 5.0 70.9 161.2 7.4 13.5 4.4 90.6 127.9 6.5 11.5 150.1 9.8 MAR-17 E 1,198.0 0.6 70.8 162.2 0.6 13.5 4.3 90.2 127.2 -0.5 11.5 171.4 8.6 SOS (m): 709.0 Dividend: 60.0 Cash + Inv (¥b): 287.95 4 yr EPS CAGR (3/11-3/15): 4.9 Mkt Val (¥ b): 1,039.4 Yield (%): 4.09 LT Debt (¥ b): 227.53 4 yr EPS CAGR (3/51-3/16): 45.0 Mkt Val ($ b): 12.92 forex ¥ /$: 80.0 PEG (3/11 / 3/11-3/15): 3.03 12 Month Target (¥): ¥1,850 Investment Thesis: • R&D attractiveness – Pipeline is full of late stage candidates which will fetch attention in 2012. Edoxaban (Ph III, factor Xa inhibitor, AF), ARQ 197 (Ph III, c-met inhibitor, NSCLC), Denosumab (Approved in JP in 2012, bone metastatase), Vemurafenib (US approval in Aug-11, Approved in EU in 2012, BRAF inhibitor, meladnoma) and CS-8958 (approved in JP, Ph III for prophylaxis anti-influenza) remain growth drivers. • RBXY’s Solid Growth Prospects Beyond Near Term Concerns: 2012-14 brings a number of First-to-File (FTF) opportunities for RBXY, together they translate into $1.2b opportunity and a number of Para IV milestones will again bring RBXY in forefront in 2012. We find that near term concerns are overly built regarding compromised Lipitor generic opportunity and probable FDA penalty (DS made provision of $500m). • Ability to exploit Japanese generic growth – with Daiichi Sankyo Espha, it is the only Japanese major well positioned to encash Japan generic opportunity • Geographic diversity and Revenue Sustainability – DS has major geographic presence which is likely to increase with time; DS is able to maintain ~90% of its current revenue base thru FY 03/17 i.e. excluding R&D pipeline contribution - a feature that most of JP peers lack. • Upside From Onetime Cash Flow: Coming quarters may unfold some agreements with global giants on its PhII onco candidates, global rights of Edoxaban etc. 28 MP Advisors
  • 29. Key Pipeline Candidates Development Drug Class Indications Market Stage Origin code PLX4032 BRAF inhibitor Melanoma EU Approved Plexxikon US Approved Anti-RANKL Bone metastases of JP Approved AMG-162 antibody cancer Amgen Osteoporosis JP Filed RA JP PhI Anti-platelet Acute coronary US/EU P3 CS-747 agent syndrome-MM Prasugrel In-house Acute coronary JP P3 syndrome-PCI Factor Xa Atrial fibrillation US/EU/JP P3 DU-176b inhibitor Venous US/EU/JP P3 In-house thromboembolism ARQ-197 c-Met inhibitor anti-cancer US/EU P3 ArQule Neuraminidase Anti-Influenza US/EU P1 CS-8958 inhibitor In-house JP Approved Anti-DR5 Target tumor cells US/EU/JP P2 CS-1008 In-house antibody PPAR gamma NSCLC US/EU P2 CS-7017 activator In-house JP P1 Anti-HER3 US/EU P2 U3 U3-1287 antibody Pharma Fms/Kit/Flt3-ITD US P2 PLX3397 inhibitor Plexxikon Anti EGFR JP P2 CIMYM DE-766 Bioscience Chymase Atopic Dermatitis US P2 Asubio SUN 13834 inhibitor Pharma 29 MP AdvisorsSource: MP Advisors; Company Reports
  • 30. TOWA (4553, ¥3,395) – Outperform Performance Will Outcast New ‘Mid Term Plan’ Fiscal Year Total % Gross Op. % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Margin Profit Chg. Margin EBITDA Profit (¥) Chg. (x) (¥) (x) 03/11 A 46.1 18.2 53.7 9.7 24.6 20.9 4.5 5.8 339.3 26.7 9.8 (271.2) (12.3) 03/12 E 50.2 8.8 53.7 9.9 2.5 19.7 4.4 5.9 342.5 0.9 9.7 (12.3) (270.5) 03/13 E 56.7 12.9 52.5 10.3 3.8 18.1 3.9 6.1 355.5 3.8 9.4 (512.2) (6.5) 03/14 E 61.9 9.1 52.6 11.2 9.1 18.1 3.6 5.9 388.3 9.2 8.6 196.1 17.0 03/15 E 66.4 7.4 52.7 12.1 8.0 18.2 3.4 6.7 419.5 8.0 8.0 459.6 7.3 03/16 E 71.1 7.1 52.8 13.1 8.2 18.4 3.2 7.2 454.3 8.3 7.3 501.9 6.6 SOS (m): 17.2 Dividend: 65.0 Cash + Inv (¥b): 9.5 4 yr EPS CAGR (3/11-3/15): 5.4 Mkt Val (¥ b): 58.3 Yield (%): 1.91 LT Debt (¥ b): 10.4 4 yr EPS CAGR (3/12-3/16): 7.3 Mkt Val ($ b): 0.686 forex ¥ /$: 80.0 PEG (3/11 / 3/11-3/15): 1.35 12 Month Target (¥): ¥ 4,100 Investment Thesis: Mid-Term Plan (MTP) announced on Nov-11 projects single digit revenue growth vis. a vis. larger increase in R&D and depreciation. Our analysis suggests that management has negated key positive components in its MTP and see several reasons why actual results will exceed these projections • In its Assumptions, Towa Does not Expect Any ‘New Major Reform’ Enhancing Generics Uptake In Next 3-Years – our take is that there would be a few ‘major changes’ in April-12 and April-14. • MTP Assumes No Fundamental Reform On NHI Pricing System: Chuikyo’s chemist survey results came after Towa MTP find that current Yakka-sa is ~8.4%. Early signals suggest that general price cuts would be ~6% while there may be additional price cuts on long listed drugs. • Investment Plans – Capex plans indicate good capicity to meet demand in future. • Towa Has always exceeded its MTP: management has been conservative unlike its peers • Besides the above, we find the following catalysts to also support valuation: 1. Acquisition Target 2. Relative Standing vs. Peers on Valuation 3. Healthcare Reforms in April-12: Incentive to Pharmacies, Change in Generic Pricing Policy etc. 30 MP Advisors
  • 31. Reforms to be Implemented in April-2012 and Implications Reform Description Impact Biggest Beneficiary Companies Premium for generics dispensing Further increase in incentive for pharmacist; Higher generic substitution at dispensing Sawai, Towa, likely to be in pocket of those who dispensed pharmacy Nichi-Iko more than 30% of generic Higher bonus points to Hospitals Awarding higher bonus point to hospitals More Rx on generic drugs to generate to get for more usage of generics using atleast 30% generics (35 points); more bonus points Hospital using atleast 20% awarded points Sawai, Nichi-Iko reduced from 30 to 28 points. Higher discount to new generic First generic version set to be min 40% Increasing discount will make generic drugs All generic launch discount to branded drug instead of current more competitive against long listed drugs companies 30% discount. Reducing the difference in price Currently there is huge price difference Reducing the gap at lower end will make Towa, Sawai, of Generic drugs between the two brands of generics. generic dugs more competitive to long listed as Nichi-Iko well as among generic drugs. Change in prescription format Removal of ‘no substitution permitted’ Increase generic substitution at pharmacy column from current Rx format and All generic compulsory writing the generic name of the companies drug. Increase in management and Points awarded to pharmacies for providing More Rx on generic drugs to generate guidance fee drug history management and guidance will All generic rise to 41 points, from 30 points at present companies Abolition of Premium for GE The abolition of the extra two points awarded Impct negatively to the sales of newly listed Dispensing and GE information to pharmacies for dispensing generic drugs generic drugs All generic provision fee and the 15 points for providing drug companies information 31 MP Advisors MHLW Source: MP Advisors;
  • 32. TORII PHARMA (4551, ¥1,462) – Outperform A Bet That Offers Only Upside! Fiscal Year Total % % Gross Op. % % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Mgn Profit Chg. Mgn EBITDA Profit (¥) Chg. (x) (¥) (x) MAR-11 A 45.34 6.9 59% 1.85 (69.8) 4% 9.4 0.93 33.0 (74.3) 44.3 8.7 167.1 MAR-12 E 49.26 8.7 59% 1.68 (9.3) 3% 9.2 1.10 38.8 17.5 37.7 28.4 51.6 MAR-13 E 51.66 4.9 59% 2.63 56.9 5% 7.5 1.65 58.3 50.4 25.1 38.7 37.8 MAR-14 E 53.39 3.3 60% 3.32 26.3 6% 6.6 2.05 72.5 24.3 20.2 45.4 32.2 MAR-15 E 59.84 12.1 60% 5.24 57.8 9% 4.7 3.17 111.9 54.3 13.1 78.7 18.6 MAR-16 E 70.64 18.0 61% 6.90 31.7 10% 3.8 4.13 145.9 30.4 10.0 107.8 13.6 MAR-17 E 85.42 20.9 61% 9.53 38.0 11% 2.8 5.65 199.7 36.9 7.3 157.5 9.3 FD SOS (m): 28.3 Dividend: 40.0 Cash + Inv (¥ b): 12.3 5-yr EPS CAGR (11-16): 27.6 Mkt Val (¥ b): 41.1 Yield (%): 2.74 LT Debt (¥ b): 0.1 4-yr EPS CAGR (11-15): 39.3 Mkt Val ($ m): 517.2 forex ¥ / $: 80.0 PEG (11/11-15): 1.6 12-month Target Price (¥): 2,400 Investment Thesis: Our Outperform rating is largely based on gain from expected positive news flow on dalcetrapib (JTT- 705, PhIII -US, CETP modulator, dyslipidemia). It is a Japan Tobacco Inc. (JTT) candidate which is partnered with Roche for global rights (Ex-JP) and aspiring for ‘first in class’ drug for increasing HDL, and carries a multi-billion global potential. Torii being the marketing partner of JTT for pharma in Japan will be selling it and is a natural beneficiary of the dalcetrapib success. It is currently under PhII trials in Japan. Elvitegravir (JTK 303, filed for combination therapy and PhIII for mono-therapy in US/EU, integrase inhibitor, partnered with Gilead, HIV) is next such candidate which will be commercialized in Japan thru Torii (Preparing for registration in Japan). 32 MP Advisors
  • 33. CETP Inhibitors at A Glance 33 MP Advisors
  • 34. CETP Inhibitors at A Glance 34 MP Advisors
  • 35. DAINIPPON SUMITOMO (4506, ¥820) – PIA Latuda Story Is Not Over Yet! Fiscal Year Total % Gross Op. % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Margin Profit Chg. Margin EBITDA Profit (¥) Chg. (x) (¥) (x) 03/11 A 379.5 28.1 71.0 30.9 (13.2) 8.1 3.1 16.7 42.0 (20.1) 19.5 (47.0) (17.5) 03/12 E 355.6 (6.3) 71.1 23.3 (24.7) 6.5 4.9 13.6 34.2 (18.6) 24.0 (15.4) (53.3) 03/13 E 353.8 (0.5) 70.6 34.2 47.1 9.7 4.2 19.2 48.3 41.1 17.0 95.1 8.6 03/14 E 343.2 (3.0) 71.6 30.3 (11.3) 8.8 4.6 16.8 42.2 (12.5) 19.4 99.4 8.3 03/15 E 321.5 (6.3) 71.7 34.5 13.8 10.7 5.7 19.3 48.5 14.9 16.9 81.1 10.1 03/16 E 324.1 0.8 71.5 50.4 45.9 15.5 4.4 28.8 72.3 49.0 11.4 77.4 10.6 03/17 E 331.1 2.2 71.6 48.5 (3.8) 14.6 4.5 27.7 69.2 (4.2) 11.9 80.3 10.2 SOS (m): 397.9 Dividend: 18.0 Cash + Inv (¥b): 112.2 4 yr EPS CAGR (3/11-3/15): 3.7 Mkt Val (¥ b): 326.7 Yield (%): 2.19 LT Debt (¥ b): 133.0 4 yr EPS CAGR (3/12-3/16): 20.6 Mkt Val ($ b): 4.1 forex ¥ /$: 80.0 PEG (3/10 / 3/10-3/14): 5.3 12 Month Target (¥): 950.0 Investment Thesis: A number of approaching milestones for its sole catalyst Latuda will unfold positive in the next 6-months and bring additional upside that was built following its US approval in Feb-11 and satisfactory Rx uptake thereafter. • Latuda Rx share since launch indicates its acceptability at psychiatrists’ level that faces limitations with the available anti-schizophrenia drugs. With its manageable extra-paramedical SEs, impressive metabolic SE profile along with its comparable efficacy to leading drugs Zyprexa (Lilly, FY11e US sales ~$2.0b, US pt. ex. Oct-11) and Seroquel (AZN, FY11 WW sales ~$5.7b) is establishing itself as an unavoidable switch option for managing schizophrenia. Latuda’s NRx pick up vs. recently launched anti-schizophrenia drugs also indicate its better acceptability. • Our PIA now looks ahead to positive outcomes from ‘Bi-polar disorder’ trials, where the opportunity is huge (~1.5x to Schizophrenia in value and 2x in growth, chart 2). A number of trials will unfold with their detailed or interim data thru mid-12 and fetch attention. 35 MP Advisors
  • 36. LATUDA : Ongoing Clinical Studies 36 MP Advisors
  • 37. EISAI (4523, ¥3,060) – Underperform ‘HAYABUSHA’ Is Difficult To Achieve! Fiscal Year Total % Gross Op. % Op. EV/ Net EPS % PE CFPS PCF (¥ b) Rev. Chg. Margin Profit Chg. Margin EBITDA Profit (¥) Chg. (x) (¥) (x) 03/11 A 768.9 (4.2) 78.2 113.1 31.4 14.7 5.7 67.4 236.5 68.1 12.9 527.9 5.8 03/12 E 658.9 (14.3) 73.7 99.6 (12.0) 15.1 6.1 63.5 222.7 (5.8) 13.7 397.0 7.7 03/13 E 647.9 (1.7) 74.2 91.4 (8.2) 14.1 6.3 58.1 203.8 (8.5) 14.9 522.8 5.8 03/14 E 595.9 (8.0) 73.7 74.0 (19.1) 12.4 7.0 46.6 163.3 (19.9) 18.6 116.1 26.2 03/15 E 595.3 (0.1) 74.7 76.3 3.1 12.8 6.8 48.1 168.7 3.3 18.0 213.5 14.3 03/16 E 602.1 1.1 74.3 74.7 (2.0) 12.4 6.7 47.1 165.1 (2.1) 18.4 193.8 15.7 03/17 E 611.5 1.6 74.5 77.1 3.2 12.6 6.4 48.7 170.7 3.4 17.8 204.0 14.9 SOS (m): 285.1 Dividend: 150.0 Cash + Inv (¥b): 180.1 4 yr EPS CAGR (3/11-3/15): (8.1) Mkt Val (¥ b): 868.2 Yield (%): 4.93 LT Debt (¥ b): 399.9 4 yr EPS CAGR (3/12-3/16): (7.2) Mkt Val ($ b): 10.85 forex ¥ /$: 80.0 PEG (3/11 / 3/11-3/15): (1.6) 12 Month Target (¥): 2,500 Investment Thesis: Management’s Mid Term Strategic Plan ‘HAYABUSHA’ embarked from April-11, aims to achieve ¥800b sales and ¥200b OP in 03/16 (Annexure 1) – which we find too optimistic. We doubt management’s projections of ~20% ROE and find their expectations from Aricept’s line extension and new products unrealistic. Eisai revenue is slated to drop following key products patent expiry i.e. Aricept and Aciphex (Pt. exp in Nov-10 and May-13 respectively); together they contributed ~¥427b (or ~56% of revenue in FY 03/11). This will lead Eisai’s EPS to fall by ~8% CAGR in 03/11-03/15. Though pipeline looks decent and can bring positive surprises, when seen in contrast to expected value built in current price Eisai does not appear to be a stock offering good risk-return profile. • Pipeline Potential Overly Built: One of its key candidate, Halaven (eribulin, microtubule growth inhibitor, 3rd line metastasis breast cancer) received FDA approval in Nov-10. Following this, Eisai has three late stage candidates – E-2007/ perampanel (Filed, AMPA receptor antagonist, epilepsy), E7080/ lenvatinib (PhIII, VEGF receptor, Thyroid cancer) and MORAb-003/ farletuzumab (PhIII, Humanised IgG1 mAb, Ovarian cancer) ) –None of these will have enough potential to nullify the loss of Aricept and Aciphex even in their best case scenarios. • Domestic Challenges will Surface Soon: 75%+ FY03/12 revenue is long listed and exposed to price cuts and generics threats. A proposed reform for April-12, suggests that premium given for new products developments on some products will be returned, hits Aricept. 37 MP Advisors
  • 38. Key Pipeline Candidates Exp. Product MoA Indication Market Stage Launch US Filed (2012) 2012 E2007 (perampanel) AMPA receptor antagonist Epilepsy EU Filed (May-11) 2012 JP PhII 2013 MORAb-003 Humanised IgG1 mAb Ovarian cancer US/EU/JP PhIII 2013 E7080 VEGF receptor Thyroid cancer US/EU/JP PhIII 2014 Microtubule growth Halaven (E7389) Sarcoma & NSCLC US/EU PhIII / II 2015 suppressor E5564 (eritoran) Endotoxin antagonist Severe sepsis US/EU PhIII 2015 Thrombopoietin receptor Idiopathic E5501/AKR-501 US PhII 2015 agonist thrombocytopenic purpura Thrombin receptor E5555 ACS US/EU/JP PhII 2016 antagonist MORAb-009 Humanised IgG1 mAb Pancreatic cancer US PhII 2016 38 MP Advisors
  • 39. RISING STARS - OUTLOOK 2012 Subita Srimal, Ph.D Khyati Thkrar, M.Sc., PGDBM Sanjeev Mishra, MBA subita@mpadvisor.com khyati@mpadvisor.com sanjeev@mpadvisor.com +1.646.657.3794 +1.646.657.3787 +1.646.434.7588 39 MP Advisors
  • 40. • What is Going Right For the sector? • What Are the Challenges? • Therapy Areas- Witnessing a Turn Around • Value creation: Recommendations RISING STARS - INNOVATIVE RESEARCH DRIVEN UNPROFITABLE COMPANIES 40 MP Advisors
  • 41. “RIGHT” IN 2011 • INCIVEK/ VICTRELIS – HCV - First Protease Inhibitors • Benlysta- Lupus- First Drug after more than two decades –Unmet Need • Yervoy and Zelboraf- mMelanoma- First Drug after more than two decades –Unmet Need • Xa Inhibitors- Bleeding, Cardio- Eliquis, Brilinta, Pradaxa, Xarelto- ACS, DVT – Better Options than Warfarin (old drug) • Soliris - aHUS - Unmet Need • Jakafi- MPN- first time unmet need • Xalkori- NSCLC- ALK+ve - first personalized drug and diagnostic approved together • Adcetris- HL, ALCL - Better Option - More Potent 2011 Was a Tribute to Innovation - New drugs for Unmet Needs/ First-in-Class were Approved 41 MP Advisors
  • 42. Will The Trend Continue in 2012? • Drug Launch in Select Therapy Areas • Oral RA • Genetic Diseases • Anti-obesity • Cancer • Gout • Dyslipidemia 42 MP Advisors
  • 43. SELECT DRUG LAUNCHES: 2012 Expected Drug Launch From Rising Star Companies Approval/ PDUFA Drug Company Indication Date Bydureon Amylin Diabetes type II 28-Jan-12 Vismodegib Roche/ Curis advanced BCC 8-Mar-12 Peginesatide Affymax/ Takeda Anemia in CKD 27-Mar-12 Qnexa Vivus Obesity 17-Apr-12 KALYDECO Vertex Pharma Cystic Fibrosis 18-Apr-2012 Contrave Orexigen / Takeda Obesity 1Q12 UPLYSO Protalix / Pfizer Gaucher disease 1-May-12 Lorcaserin Arena / Eisai Obesity 27-June-12 Ilaris Novartis/ REGN Gouty arthritis 1H12 HyQ (rHuPH20+ Ig) Halozyme/ Baxter Pri immunodeficiency 1H12 Arcalyst Regeneron Gout 30-Jul-12 AMR-101 Amarin MARINE - High 26-July-2012 (T) Ridaforolimus Ariad / Merck Sarcoma/ Osteosarcoma 8-Aug-12 (T) cabozantinib Exelixis Medullary thyroid C 2H12 Kynamro ISIS/Sanofi Ho FH 2H12 MP Advisors The Impact Will not Be as Great as in 2011 43
  • 44. But… Better Drugs For The Patients is not = to the Best Future For the Innovators! MP Advisors
  • 45. The Challenges? • SALES • REIMBURSEMENTS • PRICING PRESSURE • BETTER DRUGS IN THE MAKING Patent Are Essential But do not Guarantee Longevity or Cash Flow 45 MP Advisors
  • 46. Innovators Suffered … • Devastating in some cases- VRTX, HGSI, DNDN, etc. • Reasons were different for each co.- In some cases it was better data = shorter life span of innovation- IP may give no protection! • Others- High price or ??? • Most cases – the drop followed approval- Investors are uncertain about sales and betting more on “hope” than “reality”? • Testing times ahead in 2012 for INCY, REGN, VRTX, AMRN, SGEN, HGSI, DNDN etc. • So…….? 46 MP Advisors
  • 47. Multiple Options Ahead • Choosing between a shining star and profitability! • Paradigm shift in investing pattern-: Tap Them Young Or mid-late stage • Selective Targeting vs. Pan Drugs – A Dollar ($) war • Hope Delivered but Reality bites- GARAGE SALE= Opportunity? • Technology Platforms will continue to attract 47 MP Advisors
  • 48. Score Card- 2011 TP YoY Hit / Companies Rating Comments (LC) chg (%) Miss/ Ok Initially on robust data in HCV and partnering and Pharmasset NA 441% NA H later on acquisition Current price presents a good investment opportunity as catalysts- uptake of Eylea and clinical Regeneron $70 84% OP H data of its pipeline products will keep the momentum in 2012. Approval of INCIVEK for HCV and unexpected positive data from KALYDECO in cystic fibrosis Vertex $34 62% OP H were the highlights for 1H11. Data from various competitive drugs in HCV lead to decline in latter part of 2011. Drug targets high risk ACS pts and data and Anthera $12 30% OP H safety so far favors high risk reward opportunity Targets niche indication, pivotal trial ongoing. *Micromet $8 23% OP H Value of tech platform not realised. Clinically impressive but may not meet commercial AVEO Pharma $18 19% MP Ok success due to competition. Lack of milestone in 2011. Balanced business model of partnered programs and positive cash flow service Morphosys €23 0% OP Ok segment. Value of tech platform and pipeline should unfold in 2012-13. Lack of milestones and macro condition pulled the ArQule $7 -1% OP Ok stock down. Solely dependent on the success of fostamatinib and Rigel $8 -3% MP Ok no milestones in near term. Approval of Jakafi for MF did not please the Incyte $18 -6% OP Ok investors as concerns on reimbursement, commercial success remain. Slow but steady development. Couple of program Immunomedics $6 -8% OP Ok reached into PhIII. * Price as on the day when we initiated the coverage after Outlook'11; PoC = Proof-of-Concept ………….continued ………….continued Dark Red indicates 2011 top picks; Bold are our 2012 Top Picks Source: MP Advisors, Company Reports 48 MP Advisors
  • 49. Score Card- 2011 …continued Hit / TP YoY Companies Rating Miss/ Comments (LC) chg (%) Ok Pipeline lacks critical mass or catalysts which could Galapagos €8 -12% MP Ok move the stock. Return of compounds by GSK Promising PhIIb data but the delays in start of PhIII Ardea Biosci. $28 -20% OP Ok and no partnership announcement lead to decline in 2H11. ISIS $8 -27% MP M No milestones or new prog to drive the company. Question over the patent life of key drug *Amarin $8 -55% MP M overshadows the advantages of marketed options. Though PhIIb of HCV compounds data were *Medivir SEK59 -49% MP M positive, change in management, increasing competition in HCV lead to the decline. MXUS0HC 4.6% MSCI USA/Health Care MXUS0PB -0.4% MSCI US Pharma & Biotech * Price as on the day when we initiated the coverage after Outlook'11; PoC = Proof-of-Concept Dark Red indicates 2011 top picks; Bold are our 2012 Top Picks Source: MP Advisors, Company Reports 49 MP Advisors
  • 50. RS- Recommendations for 2012 • MITI (acq. By AMGN) • INCY • VRTX • REGN 50 MP Advisors
  • 51. Focus on Therapy Areas in 2012 • Last year was most eventful for HCV, Melanoma, Lupus and Anti Coagulants. • Exciting Data, Approvals, Spectacular Launch and Astounding Acquisitions! GILD-VRUS • This Year Also Started with a Bang for HCV- BMS-INHIBITEX acquisition • Data in HCV “oral IFN free combinations” will decide the wisdom of the “Premium Paid”. • 2012- A year to Remember for Alzheimer's – Key PhIII drug data –Make or Break • More oral options in MS and First in RA • Cancer Vaccines- DNDN rose from the graves in 2012 with good sales. Data from other Cancer vaccines will decide whether its “Hope or Hype” • Anti obesity drugs may finally see the light – though with a Narrow Label. • Biosimilars/Better Biologics- Regulatory Pathway- an Evergreen area of interest. 51 MP Advisors
  • 52. Garage Sale-Tech Focus • ALNY • ABLX • ICLL • IMMU • DVAX • IDRA • VNDA Many Trading Close at Their Cash Value! 52 MP Advisors
  • 53. MATURE BIOTECH –WATCH OUT FOR…. • VALUATIONS • SALES/EARNINGS EXPECTATIONS • GENERIC THREAT “Only Green – No Red” – Entering 2012 with High Expectations 53 MP Advisors
  • 54. Score Card- 2011 Hit / Miss/ Companies Target Price YoY chg. (%) Comments Ok World wide sales growth of Soliris in PNH and label expansion. Focus on Alexion $75 74% H orphan and rare diseases make it most eligible of an acquisition target after Genzyme. Increased focus on MS therapy area. Volume growth of Tysabri and sales Biogen Idec $60 69% H growth of Avonex (due to price increase) along with unexpected positive PhIII data from BG-12, an oral MS drug, took the stock to a new high Settlement with Bayer for regorafenib and acquisition rumor. FDA decision of Onyx Pharma $35 32% H not granting priority review in Dec ‘11 for Carfilzomib’s hampered the positive sentiment of investors. Revlimid’s malignancy related issue and generic threat from Natco Pharma Celgene $72 9% H overweigh the sales ramp up + Japan launch of Revlimid and positive pipeline news flow. Share repurchases, dividend payments and denosumab ramp-up hedges the Amgen Inc $63 9% H sales decline of ESA franchise- and blankness of pipeline. Did not perform as expected due to maturing sales growth from HIV franchise and lately announcement of VRUS’ acquisition news; however, we see it as a Gilead Sci. $45 6% Ok perfect move to gain the leadership position in HCV market using its vast experience in anti-viral therapy. 54 MP Advisors Bold are MP’s 2012 Top Picks
  • 55. VALUATION SNAPSHOT NPV of NPV of Cash & Part A Part Value of Mkt Mkt Late Stage Other Price** to A+B+C+ Company Intangibles Cap Products Pipeline Cash ($) Price** Net Cash to (Part C)* ($m) (Part A)* (Part B)* Flows* (%) Mkt Cap Gilead# 44.6 10.2 6.7 (13.0) 40.2 111% 31,286 121% Celgene 60.0 6.3 9.8 (3.7) 61.3 98% 28,174 118% Biogen 96.1 16.3 21.6 (4.1) 111.8 86% 27,429 116% Idec Alexion 51.7 9.7 17.3 (3.4) 65.1 79% 12,622 116% Amgen 70.3 1.4 2.0 (11.7) 57.5 122% 47,668 108% Onyx 15.2 22.2 9.2 (2.8) 44.0 34% 2,796 100% * $/share; ** as on 12/05/2011; # including impact of Pharmasset acquisition; Bold are MP’s 2012 Top Picks Source: MP Advisors, Company Reports 55 MP Advisors