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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`
`PTX0871
`
`MEDA_APTX01965096
`
`1
`
`CIP2080
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`PLAINTIFFS'
`TRIAL EXHIBIT
`
`PTX0871
`
`MEDA_APTX01965096
`
`1
`
`CIP2080
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`
`
`Contents
`
`• Staffing
`• Timelines and milestones for expansion
`Rationale for timing
`Forecast and assumptions
`Pricing comparison
`Promotional effort comparison
`
`CONFIDENTIAL
`
`2
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX01965097
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`1\)
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`2
`
`
`
`Staffing
`
`• Associate Product Director Candidate Search
`- Elevated to Management Recruiters of Woodbury
`- Looking for PM/APM resumes as well
`• Field Force Expansion
`- Sizing Exercise 6/29 & 6/30
`• Decisions
`- ET Presentation- before 7/1
`- Sweden?
`
`CONFIDENTIAL
`
`3
`
`HIGHLY CONFIDENTIAL-
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`f1EDI!a
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`MEDA_APTX01965098
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`3
`
`
`
`Proposed Dymista Field Force Expansion Timeline
`
`NDA filing
`forDymista
`April 1st
`
`Field Force
`Sizing
`
`Sales
`Management
`Selection
`
`Rep Interviews
`
`zs
`Forecast
`
`Sweden
`Approval
`
`OMs on(cid:173)
`board
`
`j Level II Training
`
`i
`
`Reps on-board
`
`Offer Letters I
`
`DYirv1 :1 S,'l,:.~i:::;:\ , ..
`
`LAUNCH
`
`Offer Letters
`Before PDUFA
`
`CONFIDENTIAL
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`4
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`f1EDA
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`MEDA_APTX01965099
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`4
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`
`
`Expansion Timing Considerations
`
`• Upside plan- on board first of January (prepare Q4 2011)
`
`• Base plan- on board for launch post PDUFA
`
`• Downside - on board post initial sales numbers
`
`CONFIDENTIAL
`
`5
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 00
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`5
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`
`
`Expansion Timing Considerations
`
`• Upside plan- on board first of January (prepare Q4 2011)
`- Develop relationships with customers
`- Develop category expertise prior to Dymista launch
`-ncrease net sales revenue from Astepro .15°/o, and
`-
`Xerese
`- Expansion would be EBITDA neutral/positive
`- Astepro sales offset risk of approval delay
`-ncreased sales trajectory at launch
`
`-
`
`CONFIDENTIAL
`
`6
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 01
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`6
`
`
`
`Expansion Timing Considerations
`
`• Base plan- on board for launch post PDUFA
`- Lose upside sales for Spring season
`- Sales team on-boarding during key season
`-nsufficient calls to establish customer relationship
`-
`- Delayed traction with customers and sales trajectory
`
`CONFIDENTIAL
`
`7
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 02
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`7
`
`
`
`Expansion Timing Considerations
`
`• Downside - on board post initial sales numbers
`-Team focusing on on-boarding versus driving
`sales
`- Playing catch up
`- Lower launch trajectory and sales revenue
`
`CONFIDENTIAL
`
`8
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 03
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`8
`
`
`
`General Assumptions for Forecast {Wolters Kluwer)
`
`• Market definition- all rhinitis nasal sprays
`- 44,772,157 NS TRXs in 2010
`- 8.3% growth in Rhinitis NS TRXs {2009-2010)
`• Base case net sales forecast (To Sweden .... )
`- 5% market growth for first 3 years, then flattening
`- 4.5%, 8.5%, 13% assumes 300+ reps at launch and 450 by
`end of Year 1
`- $120 WAC per Rx
`- 25% rebates (currently at 38%)
`- 5% annual price increases
`
`1- 2012 sales will be prorated based on launch date
`CONFIDENTIAL
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`f1EDI!a
`
`MEDA_APTX019651 04
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`CD
`
`9
`
`
`
`·····-·. - - - - - - - -· ·····-·····-····;,;;;;7000000 +··························································································=····=·····:····:·····:;·····::·····:;:····;,;;;.;·····;,;;;,;
`
`·--·--·----·---u~•• ---·~---~~·----·~~H.-.,.,.,..-,~--"
`
`-TRXs
`
`""C''"
`
`...
`
`.. ... , ...... __ .......... ,.....
`
`.
`
`....
`
`.. ... .,.-.. .....
`
`.. ..•. ,_. ...
`
`.
`
`.
`
`. . •
`
`.......
`
`.. .. ·-· .. ,
`
`... ··-·..
`
`""0
`
`Specifics on Forecast
`Place Holder/Forecast Requested by Sweden
`TRXs
`8000000 ··~ ........................................................................................................................................................................................................................................... .
`!
`
`
`
`i
`' !
`6000000 .f .......................................................................... ./': .............................................. ..
`' ' i
`5000000 j .......................................................................................................................................................................................................................................... .
`I
`4000000 ""t'''"""'''""'""""""'""""""""''"'"' '
`I
`3000000 ·t· ------- --
`' !
`2000000 :-··
`1000000 + ..... _ .... ~ ....... __ .. __ ..... _ ...................... ····-. -·-"· -·-·· ·······-·-·· .. -····--.... -~·-·-···- --·-··~ ...... -. -·-......... __ .-
`i
`I
`0 .; ....... -· .
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`Base
`TRXs (1000)
`Market Share
`
`$
`
`Net Sales
`2013
`322,972 $
`3,422,543
`8.5%
`
`2012
`155,089 $
`1,725,652
`4.5%
`
`2014
`544,588 $
`5,496,202
`13%
`
`CONFIDENTIAL
`
`10
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`2015
`677,032
`6,595,443
`15%
`f1EDI!a
`
`MEDA_APTX019651 05
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`
`10
`
`
`
`Place Holder/Forecast Requested by Sweden
`
`DYMISTA NET SALES ESTIMATES
`., .................................................................................................................................................................................................................... .
`
`$1 ,200,000
`
`$1 ,000,000
`
`'
`
`~
`
`$800 000
`'
`
`~---···--· -----~·-··-·-----···-----·-·· ....
`:
`:
`~
`
`-Upside
`..,.,.,Base
`
`--=- Downside
`
`0
`0
`0
`~
`::J -Ill
`
`(J)
`
`~
`ca
`(J)
`.....
`(I) z
`
`2012
`
`2013
`
`2014
`
`2015
`
`2017
`
`; .. ~
`
`.. -~
`2018
`
`.... .."~··
`2020
`
`2019
`
`2016
`YEAR
`•TRxs, market share and uptake were held constant for all 3 scenarios
`•Pricing was variable
`•Upside
`$150WAC/Rx
`•Base
`$120 WAC/Rx
`$100 WAC/Rx
`•Downside
`CONFIDENTIAL
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`11
`
`dfA-£~A
`~-~ Yilllil
`
`MEDA_APTX019651 06
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`
`11
`
`
`
`WAC/Unit
`
`Units/Rx
`
`WAC/Dymista
`
`Pricing Comparisons/Considerations
`
`Product
`
`Flonase
`
`Fluticasone
`
`Astelin (Meda)
`
`Azelastine hcl (Wallace)
`
`Azelastine hcl (Apotex)
`
`Astepro .15%
`
`Patanase
`
`Veramyst
`
`Om naris
`
`Nason ex
`
`Nasacort AQ
`
`Dymista*
`
`WAC
`
`$75.79
`
`$4.74
`
`$20-24
`
`$1.40 - $1.50
`
`$106.70
`
`$84.16
`
`$84.19
`
`$89.99
`
`$114.50
`
`$94.28
`
`$92.50
`
`$104.26
`
`$113.59
`
`$120.00
`
`$3.60
`
`$2.81
`
`$2.81
`
`$2 .99
`
`$3.74
`
`$9.43
`
`$7.40
`
`$6.13
`
`$6.88
`
`$5.22
`
`16
`
`16
`
`30
`
`30
`
`30
`
`30
`
`30.5
`
`10
`
`13
`
`17
`
`17
`
`23
`
`63%
`
`17%
`
`89%
`
`70%
`
`70%
`
`75%
`
`95%
`
`79%
`
`77%
`
`87%
`
`95%
`
`100%
`
`f1EDI!a
`
`MEDA_APTX019651 07
`
`•
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`1\)
`
`*Proposed pricing (not f inal as of 6.22.11)
`CONFIDENTIAL
`12
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`12
`
`
`
`Competitive SOV - Can we update the mgmt cockpit to get some
`of these data?
`
`Product
`
`Flonase
`
`Astelin (Meda)
`
`Astepro .15%
`
`Patanase
`
`Veramyst
`
`Om naris
`
`Nason ex
`
`Peak Retail
`Sales
`
`Year
`
`Estimated
`Sales
`Contacts
`(Current) Force Size DTC Spend
`
`$342 MUSD
`
`$149 MUSD
`
`2008
`
`2010
`
`$ 85 MUSD
`
`2010
`
`$233 MUSD
`
`2009
`
`$ 89 MUSD
`
`2010
`
`$ 1,3 BUSD
`
`2010
`
`$25 MUSD
`(2007)
`
`0
`
`?
`
`0
`.
`$
`
`$
`
`375
`
`180
`?
`.
`
`?
`
`?
`•
`
`?
`•
`
`Several approaches:
`1. Do peak sales comparison relative to sales effort (e.g., as above)
`2. Do 2009 and 2010 sales relative to sales effort and capture recent
`launches (e.g. , Veramyst)
`
`CONFIDENTIAL
`
`13
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 08
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`13
`
`
`
`Why is this expansion different?
`
`• Previous sales force (n = ???) generated XX Rxs from YY HCPs
`• Went down to deciles ...
`Poor higher decile coverage ...
`We're not optimized on key targets ... drift over time ...
`
`Will need something here if we want to
`argue that the expansion
`will pay for itself with Astepro .15°/o or
`to take the risk and go before PDUFA
`
`CONFIDENTIAL
`
`14
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX019651 09
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`
`14
`
`
`
`P&L Requirements - need to align on these for
`first pass
`
`• Blended percent rebates (commercial, gov't, co-pays etc .... )
`• Estimated returns, chargebacks ...
`COGs
`Market share/TRxs
`Ramp up curve to generate market share
`Breakdown by quarters assuming Sept. 1 launch
`Marketing and sales costs
`- A&P (To DTC or not to DTC?)
`- Personnel
`• Overhead
`
`CONFIDENTIAL
`
`15
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`f1EDI!a
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`MEDA_APTX0196511 0
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`
`15
`
`
`
`P&L Requirements - need to align on these for
`first pass - do for different expansion dates?
`Other considerations?
`
`• Market share/TRxs/Units/Cost per unit. ..
`• Blended percent rebates (commercial, gov't, co-pays etc .... )
`Estimated returns, charge backs ...
`COGs
`Ramp up curve to generate market share
`Breakdown by quarters assuming Sept. 1 launch
`Marketing and sales costs
`- A&P (To DTC or not to DTC?)
`- Personnel
`• Overhead
`
`CONFIDENTIAL
`
`16
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`f1EDI!a
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`MEDA_APTX01965111
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`16
`
`
`
`BACK UP
`
`CONFIDENTIAL
`
`17
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`f1EDI!a
`
`MEDA_APTX01965112
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`17
`
`
`
`MarketTRxs
`5000000 ·:················································ .................................................................................................................................................... .
`
`4500000 ·!········································································································································································································
`
`3000000 .. , ................................................................................................................................................................................................... ..
`
`2500000 + .................................. .
`
`2000000 .,-···········-··················································································································-··-·······-·-················································
`
`1500000 ., ...................................................................................................................................................................................................... ..
`
`1000000 ·!···· ................................................................................................................................................................................................. ..
`
`sooooo T
`0 + ........... , ............ , ............. ~ ............ , ............ , ............. ~ ............ , ............. , ............. ~ ............ , ............ , ............. ~ ............ , ............ , ............. ,
`,~ ,, ,'1.-
`'
`'
`[\,
`b
`[\,
`\:p ~>S \:fr:::s
`~ ~ ~ P.l
`~ ~
`~
`'>:>
`c::P
`~>:>
`~>:>
`~>:>
`~>:J
`~,
`"'~ "'~
`\:f\5
`($
`($
`~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
`~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
`
`-Market TRxs
`
`- - Linear (Market TRxs)
`
`CONFIDENTIAL
`
`18
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`f1EDI!a
`
`MEDA_APTX01965113
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`"'tJ
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`18
`
`
`
`Rx Dynamic (Minus fluticasone & Nasonex)
`250000 · ·--·---·-·---··-·-····-··------··--·······-·--···-······-·····-·····--·-···--·--·····-··-··-·--··---·~··-··--··-·-·--·--·"'---······---·-
`
`200000
`
`-ASTEPRO
`
`-AZELASTINE HCL
`
`FLONASE
`
`-NASACORT AQ
`hM'>",._, • .,.,_OMNARIS
`
`'""""'"'''' PATANASE
`"==<>-VERAMYST
`-
`Linear (ASTEPRO)
`
`""'#'"
`
`/qhq--
`
`-
`
`1 00000 . : .. "=! ....................... x ... { ......... ;:;;;?:-::::::~::::::?!/:::::::::::~:
`----~ L
`~
`I
`0 // "'<·'<,..,..
`,...,¢" .... ...,,..,.""·
`~.,.&fo""'"-"""'""q«o. /;"'i"
`·'«:-,.,_,_''-<»«>,-/#~~:-•m·••..-/•'"'"""""·"-'•'···m•·.w.·.·a.·,·,·•o·.,,,,,,,,.,f...,.,~'"_.yn. ,~1
`,,
`"""'"'""
`5oooo .L --·-·· .. ,/~~::<~/'.... . . .. ::,·:::>~--,,.l. ..... -,_,,~t~~~·: .... _. ....... _. ....... __ . ______ ................ ·::-··:~~··::·:: ................. .
`J v-.... ·>-=~·:.,... ....... // ....
`l :.:.O:'P:.;.-/.•;.•:-:. .. •'
`
`.
`
`6
`
`'
`
`J
`
`:
`
`«;o»:-":.-.. «flO""'~r ·
`
`~
`
`' _ /
`
`0 .! ............ , ............ , ............ ; ............. , ............ , ............. , ............ , ............ .,. ............ , ............ .,. ............ , ............ , ............. : ............ , ............ ;
`~ ~ I><
`~ !:0
`"~ ""
`~ ~
`b
`"
`"""
`R>
`!0
`c:::I~
`c:::I~
`~}::>
`"
`c:::I
`\j>S
`c:::I\;j
`c:::Ic:::J
`c:::I\j
`c:::I
`c:::I
`c::J\;j
`"}::>
`"}::>
`"}::>
`\j)j
`~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
`~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~ ~
`
`CONFIDENTIAL
`
`19
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`f1EDI!a
`
`MEDA_APTX01965114
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`"'tJ
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`
`19
`
`
`
`Rx Dynamic
`3000000 ................................................................................................................................................................................. .
`
`2500000
`
`2000000 .;,,_,_~'"'"W'''"""'" .. '' .. "'"" ' ''"''-"'"'''"'""/
`
`"-'"'"'"' .. ""'""""'·'- .. ._,,._,._.w"•"""'""'""""
`
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