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Indian Pharma – Will it Dominate the
Para IV Space?



Nimish Mehta, CFA                                     Manushi Naik, M.Sc, DIPR
nimish@mpadvisor.com                                  manushi@mpadvisor.com
+1.480.263.9400                                       +1.480.263.9400

                       Indian Pharma Macro Overview                              1
Most of the Big Para IVs With Indian Cos
                                       Indian Cos. Presence in Para IV of Top 20 Products
                  Rank             Drug Name       Innovator      Sales ’09 $m   Indian Cos. As FTFs

                     1                 Lipitor        Pfizer         5785              Ranbaxy
                     2                 Plavix     Bristol Myers      5223              Apotex
                     6               Diovan        Novartis          2500              Ranbaxy
                     8              Nexium        Astrazeneca        2800              Ranbaxy
                    10              Zyprexa        Eli-Lilly         466              Dr Reddy’s
                    15              Seroquel      Astrazeneca        900                 Teva
                    16              Singulair       Merck            4336                Teva
                    17                Actos         Takeda           3000              Ranbaxy
                    18            Effexor XR        Wyeth            520                 Teva
                    19              Atacand       Astrazeneca        3702         Sandoz/Teva/ Mylan
                    20           Gleevec/Glivec    Novartis          1088            Sun Pharma
              Source: Para IV Plus, MP Advisors


         Of the top 20 products, Para IVs are already filed on 11. Indian cos. own 6 FTFs (single or
                           shared) of these 11 Para IVs with most of them settled!




MP Advisors                                                                                            2
Small Cos. Too Entering the Space Targeting Big Products
                                            Indian Companies Comprehensive Para IV List
                                                                                        Net Profit from Para
                                                                                         IV as % of Market
        Company               No. of Para Ivs    Confirmed Para IV   Probable Para IV           Cap                 Major Products

       Sun Pharma                    30                 10                 19                  5.44%               Gleevec, Cymbalta

          Lupin                      35                 10                 25                  5.80%               Geodon, Cymbalta
                                                                                                               Zyprexa, Propecia, Fosamax
       Dr. Reddy’s                   22                 11                 10                  3.16%                      Plus D
                                                                                                                Lipitor, Caduet, Nexium,
         Ranbaxy                     15                 12                  5                 22.67%                 Actos, Diovan
        Wockhardt                    12                  4                  7                 18.04%           Stalevo, Comtan, Cymbalta

        Glenmark                     11                  5                  6                  4.62%                  Tarka, Zetia
        Aurobindo                    9                   3                  6                  1.16%                     None

          Orchid                     7                   4                  3                  1.03%                Lunesta, Boniva
          Cadila                     7                   2                  6                  0.44%                    Astelin
          Torrent                    6                   2                  4                  0.90%               Actos, Requipp XL

          Natco                      4                   0                  4                 51.80%              Copaxone, Revlimid

           Intas                     6                  2                  4                                     Seroquel XR (150 mg)
           Total                    164                 65                 99
      Source: Para IV Plus, MP Advisors




MP Advisors                                                                                                                                 3
Rich Para IV Pipeline
              Indian Pharma companies are involved in 50% of the ongoing Para IV litigations!




                                        Natco

                                       Torrent

                                         Intas
                    Company Name




                                       Orchid

                                       Cadila

                                    Aurobindo                                                   No. of Products

                                     Glenmark

                                    Wockhardt

                                      Ranbaxy

                                     Dr. Reddy

                                   Sun Pharma

                                        Lupin

                                                 0    5   10   15    20     25   30   35   40
                                                               No. of Products

                Source: Para IV Plus , MP Advisors




MP Advisors                                                                                                       4
Rich in terms of FTFs & Settlements too
                                                       Total No. of Para IVs, FTFs and Settlements



                             Natco
                              Intas
                            Torrent
                            Cadila
         Company Name




                            Orchid
                                                                                                                                       Settlement
                         Aurobindo
                                                                                                                                       FTF
                          Glenmark                                                                                                     No. of Products
                         Wockhardt
                           Ranbaxy
                          Dr. Reddy
                        Sun Pharma
                             Lupin

                                      0   2    4   6    8   10   12   14   16   18   20   22   24   26   28   30   32   34   36   38

                                                            Total No. of Products, FTFs and Settlements


       Source: Para IV Plus , MP Advisors



                                              Wockhardt & Ranbaxy have most of their FTFs settled.

MP Advisors                                                                                                                                              5
Higher No. Does Not Always Imply Higher Value
                                                         Value of Total Products, FTFs and Settlements




                                    Orchid

                                     Natco

                                      Intas

                                  Glenmark
                 Company Name




                                    Torrent                                                                                                     Settlement Sales
                                                                                                                                                FTF Sales
                                    Cadila
                                                                                                                                                Total Sales
                                 Wockhardt

                                 Aurobindo

                                     Lupin

                                   Ranbaxy

                                  Dr. Reddy

                                Sun Pharma

                                              0   2000   4000   6000   8000 10000 12000 14000 16000 18000 20000 22000 24000 26000 28000 30000

                                                                                     Sales in $ million

              Source: Para IV Plus , MP Advisors

         Though Lupin has higher number of Para IVs, it lacks behind Sun Pharma, Ranbaxy & Dr
          Reddy’s in value. Dr Reddy’s focuses on long term, low competition opportunities unlike
                                                  Lupin.
MP Advisors                                                                                                                                                        6
Para IV Launches Bunches Up As Patent Cliff Nears
                                                 Timeline of Product Launches - Volume

                               Undisclosed

                                                                                             Wockhardt
                                     2016                                                    Torrent
                                                                                             Sun Pharama
                                     2015                                                    Ranbaxy
              Year of Launch




                                                                                             Orchid
                                                                                             Natco
                                     2014
                                                                                             Lupin
                                                                                             Intas
                                     2013                                                    Glenmark
                                                                                             Dr. Reddy
                                     2012                                                    Cadila
                                                                                             Aurobindo

                                     2011


                                             0    1          2            3        4     5
                                                             No. of Products

          Source: Para IV Plus, MP Advisors




MP Advisors                                                                                                7
Most of the High Value Product To Face Erosion By 2014
                                                     Time Line of Product Launches - Value


                            Undisclosed



                                  2016                                                                       Wockhardt
                                                                                                             Torrent
                                                                                                             Sun Pharama
                 Year of Launch




                                  2015                                                                       Ranbaxy
                                                                                                             Orchid
                                                                                                             Natco
                                  2014
                                                                                                             Lupin
                                                                                                             Intas
                                                                                                             Glenmark
                                  2013
                                                                                                             Dr. Reddy
                                                                                                             Cadila
                                  2012                                                                       Aurobindo



                                  2011


                                          0   1000      2000   3000    4000      5000   6000   7000   8000
                                                                 Sales in $ million

            Source: Para IV Plus, MP Advisors


    Ranbaxy clearly leads the race in terms of number and value of the Para IV launches every year.
MP Advisors                                                                                                                8
Thank You




MP Advisors               9

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Indian Pharma - will it dominate the Para IV space?

  • 1. Indian Pharma – Will it Dominate the Para IV Space? Nimish Mehta, CFA Manushi Naik, M.Sc, DIPR nimish@mpadvisor.com manushi@mpadvisor.com +1.480.263.9400 +1.480.263.9400 Indian Pharma Macro Overview 1
  • 2. Most of the Big Para IVs With Indian Cos Indian Cos. Presence in Para IV of Top 20 Products Rank Drug Name Innovator Sales ’09 $m Indian Cos. As FTFs 1 Lipitor Pfizer 5785 Ranbaxy 2 Plavix Bristol Myers 5223 Apotex 6 Diovan Novartis 2500 Ranbaxy 8 Nexium Astrazeneca 2800 Ranbaxy 10 Zyprexa Eli-Lilly 466 Dr Reddy’s 15 Seroquel Astrazeneca 900 Teva 16 Singulair Merck 4336 Teva 17 Actos Takeda 3000 Ranbaxy 18 Effexor XR Wyeth 520 Teva 19 Atacand Astrazeneca 3702 Sandoz/Teva/ Mylan 20 Gleevec/Glivec Novartis 1088 Sun Pharma Source: Para IV Plus, MP Advisors Of the top 20 products, Para IVs are already filed on 11. Indian cos. own 6 FTFs (single or shared) of these 11 Para IVs with most of them settled! MP Advisors 2
  • 3. Small Cos. Too Entering the Space Targeting Big Products Indian Companies Comprehensive Para IV List Net Profit from Para IV as % of Market Company No. of Para Ivs Confirmed Para IV Probable Para IV Cap Major Products Sun Pharma 30 10 19 5.44% Gleevec, Cymbalta Lupin 35 10 25 5.80% Geodon, Cymbalta Zyprexa, Propecia, Fosamax Dr. Reddy’s 22 11 10 3.16% Plus D Lipitor, Caduet, Nexium, Ranbaxy 15 12 5 22.67% Actos, Diovan Wockhardt 12 4 7 18.04% Stalevo, Comtan, Cymbalta Glenmark 11 5 6 4.62% Tarka, Zetia Aurobindo 9 3 6 1.16% None Orchid 7 4 3 1.03% Lunesta, Boniva Cadila 7 2 6 0.44% Astelin Torrent 6 2 4 0.90% Actos, Requipp XL Natco 4 0 4 51.80% Copaxone, Revlimid Intas 6 2 4 Seroquel XR (150 mg) Total 164 65 99 Source: Para IV Plus, MP Advisors MP Advisors 3
  • 4. Rich Para IV Pipeline Indian Pharma companies are involved in 50% of the ongoing Para IV litigations! Natco Torrent Intas Company Name Orchid Cadila Aurobindo No. of Products Glenmark Wockhardt Ranbaxy Dr. Reddy Sun Pharma Lupin 0 5 10 15 20 25 30 35 40 No. of Products Source: Para IV Plus , MP Advisors MP Advisors 4
  • 5. Rich in terms of FTFs & Settlements too Total No. of Para IVs, FTFs and Settlements Natco Intas Torrent Cadila Company Name Orchid Settlement Aurobindo FTF Glenmark No. of Products Wockhardt Ranbaxy Dr. Reddy Sun Pharma Lupin 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 Total No. of Products, FTFs and Settlements Source: Para IV Plus , MP Advisors Wockhardt & Ranbaxy have most of their FTFs settled. MP Advisors 5
  • 6. Higher No. Does Not Always Imply Higher Value Value of Total Products, FTFs and Settlements Orchid Natco Intas Glenmark Company Name Torrent Settlement Sales FTF Sales Cadila Total Sales Wockhardt Aurobindo Lupin Ranbaxy Dr. Reddy Sun Pharma 0 2000 4000 6000 8000 10000 12000 14000 16000 18000 20000 22000 24000 26000 28000 30000 Sales in $ million Source: Para IV Plus , MP Advisors Though Lupin has higher number of Para IVs, it lacks behind Sun Pharma, Ranbaxy & Dr Reddy’s in value. Dr Reddy’s focuses on long term, low competition opportunities unlike Lupin. MP Advisors 6
  • 7. Para IV Launches Bunches Up As Patent Cliff Nears Timeline of Product Launches - Volume Undisclosed Wockhardt 2016 Torrent Sun Pharama 2015 Ranbaxy Year of Launch Orchid Natco 2014 Lupin Intas 2013 Glenmark Dr. Reddy 2012 Cadila Aurobindo 2011 0 1 2 3 4 5 No. of Products Source: Para IV Plus, MP Advisors MP Advisors 7
  • 8. Most of the High Value Product To Face Erosion By 2014 Time Line of Product Launches - Value Undisclosed 2016 Wockhardt Torrent Sun Pharama Year of Launch 2015 Ranbaxy Orchid Natco 2014 Lupin Intas Glenmark 2013 Dr. Reddy Cadila 2012 Aurobindo 2011 0 1000 2000 3000 4000 5000 6000 7000 8000 Sales in $ million Source: Para IV Plus, MP Advisors Ranbaxy clearly leads the race in terms of number and value of the Para IV launches every year. MP Advisors 8