throbber
Sender:
`
`Sent:
`
`Recipient:
`Subject:
`Attachments:
`
`Loesch, Stuart </O=CARTER-WALLACE/OU=EXCHANGE ADMINISTRATIVE
`GROUP (FYDIBOHF23 SPDLT)/CN=RECIPIENT 8/CN=LOESCH, STUART83C>
`Friday, November 14, 2014 4:13:48 PM
`Betsy Orrison
`<betsyeo@synopiarx.com>
`DYMISTA 2015 DRAFT Brand Plan
`Dymista FULL- US Marketing Plan 2015 111414.pptx
`
`Betsy,
`Can you please send the attached brand plan to Steve and Bill?
`Kind Regards,
`Stuart
`
`Stuart Loesch
`Vice President, Mazketing
`265 Davidson Avenue | Somerset, NJ 08873
`T: 732-564-2407| C: 609-619-1473 | F: 732-564-2407| stuartloesch@meda.us
`
`NOTICE: This message contains information which is confidential and may also be privileged. The information mayonly be uscd by
`the intended recipient(s). If you have received this message in crror, please notify the sender and remove ii fromyour syslem.
`
`1
`
`
`EXHIBIT
`
`
`
`
`
`
`stle-7
`JW U-2A}Hb
`
`900-631-4gg9
`PENGAD
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`MEDA_APTX02486008
`
`1
`
`CIP2074
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`PTX0271-00001
`
`

`

`
`
`20000-12Z0X1d
`
`
`
`Marketing Plan 2015
`
`
`
` _ drug of
`
`
`choice
`for allergic rhinitis
`
`
`
`»
`
`PRC
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`2
`
`MEDA_APTX02486009
`
`

`

`Marketing
`
`Plan 2015
`
` MDA
`
`€0000-l220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX02486010
`
`

`

`Content
`*
`
`Product Profile
`
`Market / Competitor
`
`Planning
`
`Strategy
`
`Marketing
`
`Sales Force
`
`Upside/Downside Potential
`
`¢
`
`«
`
`*
`
`*
`
`*
`
`*
`
`*
`
`MEM
`
`Summary
`
`-3-
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`MEDA_APTX02486011
`
`v0000-1220XLd
`
`

`

`Product Profile
`*
`Trade Name: Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray 137mcg/S0mcg per
`Spray
`Launch Date: September 24, 2012
`Patent Protection: 2026
`Substance Class: Nasal Spray
`Active Ingredients: azelastine hydrochloride/fluticasone propianate
`Indication: Seasonal Allergic Rhinitis (SAR) for patients 12 years and older who require treatment with both
`andfluticasone propionate for symptomatic relief
`azelastine hydrochloride
`Dosage: 1 spray/nostril 2x daily
`Pack size: 23 grams netfill (120 metered sprays)
`Prices: $145.95 (wholesale acquisition cost}; $82.20 (net price); most patients payaslittle as $14 with the
`copay card or receive $100 off their cash price
`Reimbursement status: Percent of Lives Covered by Status
`
`Preferred
`Covered (Unrestricted Tier 3)
`Restricted (PA/SE)
`Not Covered
`-4-
`
`RES
`
`2015
`32%!
`26%
`12%
`30%
`
`PA= Prior Authorization
`First half of 2015 prior to Nasonex generic
`SE= Step Edit
`
`Dymista
`2Notlisted refers to a database limitation; assume Tier 3
`
`.
`
`a
`
`$0000-1220X1d
`
`HIGHLY CONFIDENTIAL-
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`
`MEDA_APTX02486012
`
`

`

`Disease State
`
`90000-1220X1d HIGHLY CONFIDENTIAL-
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`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`
`
`MEDA_APTX02486013
`
`

`

`Disease State
`*
`Seasonal Allergic Rhinitis (SAR) is a condition in which outdoor allergens such as
`causes the mucous membranesof the nose
`weeds, molds or flower pollen
`become inflamed which manifests nasal symptoms such as
`running nose, nasal
`congestion, sneezing and nasal
`itching.
`
`According to DataMonitor,it is estimated that between 40-60 million people in the
`United States suffer from allergic rhinitis
`
`based on their symptoms
`and treat through
`Patients often
`self-diagnose
`(OTC) options, however,it is noted that patients often use
`counter
`multiple
`and costs are substantial
`medications to control their symptoms
`
`over-the-
`
`mEDa
`
`According to a
`Marple and
`Colleagues Study, many patients
`treatment options and the type of relief they offer
`.
`
`are confused by the
`
`Dymista
`
`£0000-1220X1d
`
`HIGHLY CONFIDENTIAL-
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`
`MEDA_APTX02486014
`
`

`

`Diagnosis and Treatment
`
`*
`
`*
`
`«
`
`Primary
`commonly
`
`Care
`Physicians, Otolaryngologists (ENTs),
`treat SAR
`
`and Allergists
`
`most
`
`Physicians often diagnose
`
`SAR when treating other ailments such as asthma
`
`Patients that seek physician intervention tend to have more severe
`which combination
`is often prescribed
`therapy
`
`symptoms for
`
`m=pA
`
`,
`
`Dymista.
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`8
`
`MEDA_APTX02486015
`
`80000-1220X1d
`
`

`

`Conclusions
`«
`It has been documented that the use of multiple medications is costly for the
`an
`as it provides multiple
`patient therefore this presents
`opportunity for Dymista
`benefits in one
`product
`
`
`
`*
`
`*
`
`nena
`
`The SAR market continues to grow and there are
`opportunities for the Dymista
`with
`patients to combat over-the-counter switch
`messaging
`
`Continue appropriate coverage of the physician targets via sales force efforts
`
`Dymisia
`
`60000-1220X1d
`
`HIGHLY CONFIDENTIAL-
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`
`MEDA_APTX02486016
`
`

`

`
`
`
`Market Dynamics
`
`
`
`PAE
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`MEDA_APTX02486017
`
`01000-LZZ0X1d
`
`

`

`~
`
`—
`MarketDynamics
`Market
`+
`Market Classification: Allergic Rhinitis (Seasonal and Perennial)
`
`MarketClassification&Relevant
`
`Spray
`
`Market is a $3.43 billion’ (gross sales);
`
`Rhinitis Nasal
`
`~
`
`Allergic
`56 million’ TRxs
`-
`Generic Nasal Sprays Represents
`*
`$4.46B dollars’
`*
`80% of TRx Business
`«
`Fluticasone Propionate largest generic (41 million TRx)?
`Branded Nasal Sprays Represents
`*
`$1.98B dollars’
`+
`20% of TRx Business
`*
`[nhaled nasal steroid (INS): Nasonex largest INS brand representing $1.35B (~$600 MUSD net
`sales)?
`
`*
`
`*
`
`KER
`
`Managed Care coverage drives performance:
`+
`INS: generic Flonase Tier 1; Nasonex preferred Tier 2 (75% of covered lives)
`*
`Statuslikely to change based on flonase gaing over the counter
`Generics will cover 70-90% of patient lives
`
`+
`
`ee
`
`Dyrnisia
`
`LL000-LZZ0X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`1
`
`MEDA_APTX02486018
`
`

`

`[hedovetenPissAgha
`
`~~
`
`
`
`—
`Quantitative Development
`Nasal Spray Market
`TRx up ~6% over
`2013; $3.4B in Value
`
`5 60,000,000 rss
`
`i
`! 50,000,000
`;
`
`£ 40,000,000
`:
`
`Nasal Spray TRx
`emnnnrnenninnineunastinrtereit tiene
`
`£ $4,000
`$3,500,
`
`:
`: $3,000
`f
`+
`$2,500
`
`Nasal Spray MBS $5(nantions)
`
`+
`
`
`
`
`
`30,000,000
`
` :
`} 20,000,000
`
`! 10,000,000
`i
`
`
`2018
`
`2014
`
`$1,000
`
`$500
`$0 4
`
`2007
`
`2008
`
`“
`
`-
`
`2009
`
`-
`
`2010
`
`2011
`
`2012
`
`¢
`
`2013
`
`2014
`
`| $2,000
`*
`$1,500
`
`i :
`
`
`MDS S$ (pro) # MBS $$ SSMEEPER CAGR=compound annual growthrate
`
`-W-
`
`
`
`€1000-1-220XLd
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`12
`
`MEDA_APTX02486019
`
`

`

`
`
`—
`
`
`
`‘Quantitative Development
`Nasal Spray TRx Market Performance
`Nasal Spray Market TRx
`
`-~-
`
`6,000,000
`
`5,000,000
`
`4,000,000
`
`poe
`
`
`
`titimatintinsttiainininimtn mente aminemnetne nina iinincnnacenanesnnnnantaennh
`
`da
`3,000,000 ornremrnnnaanrminitnnnintntatsntnenintitnaneniniatninnintinnnnintiataniiseitinictnnitntns
`unanaanamenresneiungoamcnerne nena a eiminaranche nmincincntainiansentencetnrneeims me
`
`2,000,000 “forenoon
`.
`.
`.
`i
`acer SRI:
`nn
`*Booevtan
`fhenoneasetnecernsmgasttMrNNRhy nagesssgaoanfon
`1,000,000 4--"
`
`
`Xe
`
`yy
`
`PP
`a OD
`NY
`SP Ms
`SP
`USP
`SP
`s
`SPS? MP
`th nh
`KY
`MY
`Sh
`NY
`a pe PPP PM?
`Wh
`as
`PM
`he
`NY
`WV Wo
`PP We hh
`SKK PM KG KK GF we
`FS SS SS
`FF yh wh
`ew gy ys
`
`vesiowa Branded NS Market
`Total NS Market
`
`
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`13
`
`MEDA_APTX02486020
`
`€1000-L220X1d
`
`

`

`Qualitative Development-— Decline in Branded Nasal
`Spray Market requires brands fight for smaller piece of
`pie .
`5 years due to patent exclusivity loss and stricter managed care restrictions
`
`
`apenas peas ovo
`
`Brand Share of the Nasal Spray Market
`
`
`
`
`
`
`60%
`
`50%
`
`} 1i 5 )
`
`: |
`
`+
`40%:
`;
`
`
`
`4
`
`20%
`
`10%
`
`4
`
`#
`
`§
`
`:
`“F"
`%
`4
`7
`7
` 0% ++
`fi
`!
`Jan-07
`|Jul-o9
`rtat6
`Apr-03
`ule P
`Jan-c9
`Jul-08
`ule12
`ul-23
`ct-10
`Oct-11
`ct-13
`ct-09
`Oct-08
`ct-12
`pr-14
`Apr-08
`Apr-07
`pr-i0
`Jul-o7
`Jan-08
`an-10%
`an14%
`an-a2t
`pr?
`8geq Source: SymphonyHealth, TR
`Note: Generic segmentis the "easy" to access segment due to lower managed care formulary restrictions
`and lowerout of pocket cost to patient
`
`atten
`Dymisia
`
`
`
`:f
`
`ul-a4a’
`
`|
`
`4
`
`%
`
`:A
`'J
`:O
`»J
`
`%
`:Jan-13
`
`3
`jApr-13
`
`7
`
`7
`
`:O
`Ef
`
`»J
`
`:J
`
`! a
`
`4
`:Jan-11
`
`%
`
`;O
`
`%
`iJul-10
`
`7
`
`4
`
`EA
`EJ
`|O
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`14
`
`MEDA_APTX02486021
`
`¥L000-1L220X1d
`
`

`

`Branded Nasal Spray NRx Market Share
`wpecnrrnrcsin
`ttamnemascnmmemnttnnnernat ncatttremeamenincimpimananttintnntimimpcaNe eeeeen innteeta ncEnemnientecenaingietacnetaetesstnseenmcecicatin
`BDU
`
`-
`
`10%
`
`oe
`
`a
`
`
`Jan'14
`
`
`Feh'l4 Mar'l4 Apr'l4 May'l4 Jun'l4
`
`
` Jul'l4 Aug'l4 Sep'l4 Oct 'i4
`
`- Oct'13 Nov'l3 Dec'l3
`
`2%
`
`MES
`
`sqASTEPRO
`vse PATANASE
`«wom
`SiQNASL
`All Other Branded
`Of note, Nasonex remains mostly flat at 68%-70% market Share
`
`see DYMISTA
`<#ifjon VERAMYST
`
`segOMNARIS
`sevipaom ZETONNA
`
`watt tate
`
`mente naar tmnt
`Dymista
`
`$1000-L220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`15
`
`MEDA_APTX02486022
`
`

`

`t=<“s—sS conn
`
`
`
`“MethodofPayment.
`Cure YTD | PrevYTD
`
`
`=
`;
`|
`eal
`Prev YTO
`
`‘Medicare
`Cashioe io:
`
`curr v1 saa) CurrYTD
`_
`|
`fF
`
`BRAND
`“A% |
`|:
`6%
`A%
`--20%
`21%
`ASTEPRO.0:15%
`-2%.
`1%
`[ay
`9%
`12%
`am
`™m
`5%
`
`[1%
`| 13% |
`Bm
`27%
`f
`
`fae
`
`15%
`16%
`13%
`16%
`
`es
`
`
`|
`: egg [gM EES © ggg
`NASONEX
`2%
`[|
` neZETONNA
`
`
`
`ONINARIS
`13%
`12%
`12%
`10%
`Te | 6m!
`[|
`
`WeRE
`4%
`10%
`9%
`og
`4%
`9%
`A 96
`of 9m TE
`
`2%
`9%
`
`lf Nasonex goes OTC, 89% of TRxs come from managed
`care which has major
`on branded & Dymista business
`impact
`Source: Symphony Health -PHAST National Database
`-
`-
`15
`Total Third: Third Party/Commercial insurance
`
`‘|S
`
`|
`ame
`5%
`
`6%
`
`87%
`
`*
`
`Majority of branded competitors get business from managed care/3" party+
`
`PRESS
`
`|
`
`—
`BtEERD
`
`oe
`tS
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`16
`
`MEDA_APTX02486023
`
`91000-1L220X1d
`
`

`

`~~
`
`80%
`
`70%
`
`BymistaManageCareCoverageComparabletoNew
`ch80ne(ArcsREESTERSELEYetEL eae HENORONSAONCMSNHeEHSEESATESEPEisNetwteemhantseante3
`Competitors
`:
`i:E
`
`: F
`
`ormulary Definitions
`formulary; often results in a lowest brand copayto patients
`on
`Preferred: Brand is preferred
`Covered: Often the secand lawest brand copay to patients
`Restricted: Drug is not suggested forfirst-line therapy, often requires PA (prior approval) or a SE
`(step-edit)
`SEIS Not Covered: Drug is not covered on formulary
`Not Listed: Data baselimitation; assumerestricted tier
`
`aa.aa-l
`ee
`Dymista
`
`Z1000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`17
`
`MEDA_APTX02486024
`
`

`

` Nasal Spray Market
`
`Dymista
`
`2%
`
`a ASSISTANCE PROGRAMS
`
`&§ CASH
`
`% COMMERCIAL
`
`# MEDICARE
`
`Dymista
`
`= MANAGED MEDICAID #7 MEDICAID
`
`HIGHLY CONFIDENTIAL
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`-
`
`18
`
`MEDA_APTX02486025
`
`81000-L220X1d
`
`

`

`Commercial Claims
`
`Filled Claims
`Reversed Claims
`Branded Product
`Rejected Claims
`
`
`ASTEPRO 0.15%
`
`
`DYMISTA
`
`NASONEX
`
`OMNARIS
`
`PATANASE
`6%
`
`11%
`QNASL
`
`
`14%
`RHINOCORT/AQUA
`
`VERAMYST
`
`ZETONNA
`Generic Product
`85%
`AZELASTINE
`
`
`
`
`FLUTICASONE
`88%
`8%
`3%
`
`
`
`TRIAMCINOLONE ACET.
`82%
`12%
`6%
`
`Alf Products
`85%
`10%
`NASAL SPRAY MKT
`
`
`
`5%
`
`
`
`
`NEDA
`
`~418-
`
`Fill Rate= Prescription is filled
`Rejection Rate= Script was not approved
`Reversal Rate= Script was approved but for various reasons neverfilled
`
`Dymista
`
`61000-L220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`19
`
`MEDA_APTX02486026
`
`

`

`Competitive
`
`Environment
`
`
`
`
`
`
`of choice
`_ drug
`|
`for allergic rhinitis
`.
`
`2 .19-
`
`
`
`Meo
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`a
`
`MEDA_APTX02486027
`
`02000-12Z0X1d
`
`

`

`Competitive
`
`Environment
`
`*
`
`Branded nasal spray market contains 19 brands, main competitors
`~
`Nasonex
`
`are:
`
`-OTC’s
`-
`
`Qnasl
`
`—
`
`Patanase
`2014 TRx Market Share Snapshot (7/2014):
`
` mea
`
`-
`
`-
`
`20
`
`a
`Dymista
`
`12000-LZZ0X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`21
`
`MEDA_APTX02486028
`
`

`

`
`
`
`
`Update to Nasacort24 Over-the-Counter
`
`*
`
`«
`
`*
`
`*
`
`-
`
`+
`
`for 2014
`9.9 MM units projected
`$124 MM sales projected for 2014
`Over $400 MM in advertising
`awarenessto the consumer
`Bringing
`$15 to $17 for a 30 day supply
`Key message: 24 hour allergy
`
`relief
`
`regarding nasal steroid sprays
`
`MEDA
`
`-21-
`
`is
`basse
`HagalAllergy Saray
`
`Nasacore
`Allergy 24HR
`BE
`
`
`
`aa
`Dynnista
`
`HIGHLY CONFIDENTIAL
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`-
`
`2
`
`MEDA_APTX02486029
`
`22000-b220X1d
`
`

`

`OTC
`
`Digital Presenceis
`
`Climbing
`
`OTC category spend continues to climb and be more
`aggressive
`Zyrtec had the strongest OTC digital presence in 2013
`Zyrtec spent almost $11mm in
`digital spend in 2013
`Claritin maintains the second largest OTC presence with over $4mm in spend
`
`OTC Search Landscape
`
`$699,000.08
`
` Source: Kantar 2013
`
`PELDA
`
`-22-
`
`OTC Display Compatition
`400.00
`38,800.00
`S08,
`537,5c0.00
`
`
`
`8 Allegra
`# Claritin
`a Zyrle
`
`i
`i|
`i
`
`
`
`2: Masacaul
`"Adil Alten
`
`ealingea me Chaitin
`
`6 Pyro.
`
`Dymisia
`
`€2000-1220XLd
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`23
`
`MEDA_APTX02486030
`
`

`

`
`
`¥Z000-L220X1d
`
`Allergy
`
`Search Landscape
`
`*
`
`One
`
`Playing Field For All OTC, DTC Across Same
`
`Keywords
`
`FRRGSR
`
`
`
` PEER Se,
`
`or
`
`BIEy
`
`
`
`
`
`
`
`
`acomné OTG Nasal Spray
`ro
`Lact
`four Massl agergy. Sign Up New To Sava!
`
`us Alle
`rey Congestion
`ar
`
`Nasacort [OTC]
`
`Claritin [OTC]
`
`enh Raeligi,
`H Suarardee
`
`-
`
`HOPs: Get inte
`
`
`
`
`
`
`
`
`CP
`
`Dymista [Rx]
`DRY
`Oficla! Site
`
`SUSE
`
`-23-
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`24
`
`MEDA_APTX02486031
`
`

`

`Respiratory
`
`Market Key Events 2015
`
` 947
`
`
`
`MEDA_APTX02486032
`
`$2000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`25
`
`

`

`92000-1220X1d HIGHLY CONFIDENTIAL -
`
`ee
`~
`Stopped perso
`promotion
`+ Predominantly Ter 3, restricted status
`
`.
`
`|
`
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`26
`
`MEDA_APTX02486033
`
`

`

`Market Dynamics
`*
`Overall Nasal Spray Market is
`has declined 13.1%
`
`-
`
`
`
`Conclusions
`
`growing
`
`due to
`
`generics at 6%; branded market
`
`*
`
`*
`
`*
`
`has
`
`major impact
`
`on Brand Prescription
`
`Managed Care Formulary Coverage
`filled
`being
`56 million Rxs of Allergic Rhinitis
`2015 there will be approximately
`-
`no market changes);
`11.2M TRxs
`20% will be branded (if
`no market changes); 44.8M TRxs
`80% would be generic (if
`are
`Market changes
`planned whichwill impact the branded Rx market:
`Major
`-
`Flonase OTC launch in
`January 2015
`Nasonex goes Generic or OTC
`
`-
`
`-
`
`MEDA
`
`DOB
`
`enn
`Dymista
`
`22000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`27
`
`MEDA_APTX02486034
`
`

`

`_ drug of choice
`
`for allergic rhinitis
`
`|
`
`
`
`.
`
`m4
`
`Pees
`
`(aT
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`28
`
`MEDA_APTX02486035
`
`82000-1220X1d
`
`

`

`Patient Insights
`
`*
`
`*
`
`*
`
`Patients need to feel absolutely
`intervention
`-
`
`Patients do not view allergy
`
`miserable before they will go to a HCP for
`
`as a serious enough illness to seek physician intervention
`home remedies and OTCs-— these actions are often
`
`Patients often cycle through
`based on the recommendations offriends or
`
`The Patient Buying Process for allergies
`seasons or years for patients
`to
`
`cycle through
`
`a TV ad
`
`prompted by
`now consists of 8 steps and can take several
`
`meme
`
`96
`
`Dymista
`
`62000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`29
`
`MEDA_APTX02486036
`
`

`

`Patient Insights
`*
`Patients are
`negative regarding their allergies and symptom relief
`
`Top Topics
`
`in
`Messages about
`Allergies by Sentiment
`—
`January 1, 2013
`May 31, 2014
`4 Neutral
`i Negative
`i Positive
`
`Symptoms
`
`Allergy Trigger
`Medication Efficacy
`
`Lifestyle Impact
`
`Diagnosis
`OTC vs. Rx
`
`PES
`
`-
`
`09
`
`General Mention HCP Interaction
`
`i
`|
`0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
`
`Dymista:
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`20
`
`MEDA_APTX02486037
`
`0€000-12Z0X1d
`
`

`

`Physician Insights
`
`*
`
`*
`
`*
`
`*
`
`*
`
`*
`
`*
`ELA
`
`Allergists tend to position Dymista at the end of the treatment algorithm
`-
`
`Step-up training
`
`ENTs tend to move more
`
`toward Dymista
`quickly
`Coast/hassle factor seems to take precedencein positioning
`or other outcomes measures
`
`Primary Care Physicians have low awareness for Dymista
`HCPs focus on
`
`Dymista components instead of benefits
`
`over
`
`patient satisfaction
`
`Physicians realize that they need to demonstrate value to their allergy patient
`are
`losing their business to OTCs
`Physicians realize that they
`MarketSizing Study 3/13 & Converseon Social Listening Study 6/14
`30
`
`Dymisia
`
`L€000-LZZ0X1d
`
`HIGHLY CONFIDENTIAL-
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`
`31
`
`MEDA_APTX02486038
`
`

`

`Product Dynamics
`*
`For
`July 2014, ENTs contributed 29% of Dymista NRx volume (n=11,827),
`care contributed 29%
`allergists contributed 27% (n=11,101) and primary
`(n=11,827)
`
`«
`
`Major Marketing Achievements (4.2)
`-
`Since its launch, Dymista has increased TRx market share in the branded nasal spray
`(BNS) market and is now at 10.1%
`
`-
`
`-
`
`Dymista is the #2 product in TRx volume in the branded nasal spray market
`
`Dymista market share within primary
`
`care has grown 31% YTD
`
`MESA
`
`a1
`
`Dymista
`
`Z£000-L2Z0X1d
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`eS
`
`MEDA_APTX02486039
`
`

`

`Conclusions
`
`*
`
`*
`
`+
`
`*
`
`Exploit the misery of the allergy patients and
`
`give them a unified voice
`Continue to build upon the success of the sales team
`
`Leverage KOL advocacyto continue to build brand loyalty and
`
`recognition
`
`Increase managed
`
`care access and reduce pharmacy switching
`
`rs
`
`~32-
`
`—
`Dymisia
`
`€€000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`33
`
`MEDA_APTX02486040
`
`

`

`
`SWOT Analysis
`
`
`
`_ drug of choice
`for allergic rhinitis
`
`
`~
`
`|»
`
`MEA
`
`.33-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`34
`
`MEDA_APTX02486041
`
`ve000-1220X1d
`
`

`

`CU
`
`—pymistaSWOTAnalyaia
`
`Strengths
`
`Weaknesses
`Nasal spray delivery is viewed as cumbersome to patients
`Sales force reach/frequency
`Narrowindication (lack of PAR, ocular, & ped)
`Lack of resources for pull through
`
`Superior efficacy
`Rapid onset of action with inflammation control with unique
`delivery system and fine mist spray
`—
`the only one in the market
`Uniqueness of product
`Safety profile
`
`
`Threats
`Majority of nasal spray market is generic (low-cost)
`With more OTC options, patients may go to the doctor less or
`delay seeking intervention
`Nasonex may go generic resulting in patients switching due
`to low cost and high brand awareness; MHC may no longer
`cover brands
`Accessdeclines to less than 58% oflives
`Low consumer awareness
`
`Opportunities
`Patients and Physiciansstill feel unmet need in seasonal
`—
`Dymista opportunity
`allergy products
`Heighten awareness of misery and drive patients to the
`physician
`Flonase & Nasonex going over-the-counter (OTC) giving
`greater share of voice in the branded Rx market to Dymista
`Patient/Consumer audience
`
`EER
`
`-34-
`
`
`
`S€000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`35
`
`MEDA_APTX02486042
`
`

`

`Conclusions from SWOT
`
`—
`
`the only “One”in the market
`is unique
`Dymista
`Dymista has a clinical difference with
`efficacy and speed of onset
`care coverage without restrictions will be
`To achieve 2015 sales goals, managed
`critical
`
`Plan to focus on
`
`patients through digital in 2015; still unmet need in Seasonal
`
`Allergy products
`Major market changes continue to
`impact branded Rx market
`-
`patients may leave Rx market, but many may come back due to
`OTC impact
`dissatisfaction
`—
`
`Generic Nasonex
`Tier 1 for
`
`and patients may opt for lower priced productthatis
`
`*
`
`*
`
`physicians
`formulary coverage
`care
`organizations may abandon second tier category for
`
`Managed
`MEDS
`
`3
`-35-
`
`allergic rhinitis
`Dymista
` ornereinenennecenaee
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`36
`
`MEDA_APTX02486043
`
`9€000-b220X1d
`
`

`

`
`
`Key Issues
`Strategic Planning
`
`
`
`2€000-1220XLd
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`a7
`
`MEDA_APTX02486044
`
`
`
`
`
`
`©
`
`
`
`drug
`for
`allergic
`
`of choice
`rhinitis
`
`Mle
`
`-
`
`-
`
`36
`
`
`
`

`

`Key Issues
`
`is
`
`grouped
`
`2)
`
`into a branded marketthat is
`
`declining, though Dymista is
`
`1) Dymista
`not
`SAR sufferers minimize their suffering and don’t see the doctor until their misery
`is intolerable
`Brand awareness is low among non-targets and consumers
`3)
`4) Sales force reach is limited due to size and priority focus
`out of our control
`5) Managed Careis reluctant to
`change formulary-
`
`MEV
`
`-37-
`
`SESE
`Dyrnista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`38
`
`MEDA_APTX02486045
`
`8€000-b220X1d
`
`

`

`~~
`
`pymistaStrategicMap
`
`°
`hreugh cufrentplan:
`|
`ovetage:and leverage.new
`°-
`‘copay program via a surround. :
`ssound approach =
`
`+) MEDA_APTX02486046
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`39
`
`6€000-1220X1d
`
`

`

`tePad
`tyes
`aeMerenBete
`
`07000-12Z0X1d
`
`2015 Major Initiatives Aligned to Strategies
`
`“Brand awareness is low.
`ig
`an
`nofi-targets
`
`:
`
`Salesforce reachis
`
`.
`
`ManagedCareis reluctant
`formulary-out.
`“
`to change:
`“ofur: control
`
`|
`i
`
`:
`- Social. media driving .
`patients to
`Shieezecast
`
`,
`
`al
`
`$
`
`speaker progran
`-
`to.consumers:
`
`Commiinication Portal
`beet
`E-details.
`..
`MP4001
`promotion
`HEORdata: promotion
`Banner ads.
`|
`|, Paid’search;,
`Enhanced we
`bsites
`‘Virtualspeaker:progtam:
`
`Pharmacy. Flashcar
`Compass Research
`
`5
`
`‘Communication.
`
`Portal
`
`Convention presence
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`40
`
`MEDA_APTX02486047
`
`

`

`~~"
`
`CC
`
`9yerthecTopInitiatives
`
` MEBs
`
`-40-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`Al
`
`MEDA_APTX02486048
`
`-7000-l2c0XLd
`
`

`

`a5
`
`
`
`27000-LLZ0X1d
`
`ATRs & sales manth-over-mo
`“Increase in'script volume with more new pat
`Digital downloads
`Access Copay Card©
`
`marketresearch(ATU) showing use of Dymista increasing.in range of patient.
`
`Digital downloads ef Access Copay Card “*-, MEDA_APTX02486049
`
`‘IncreaseIn script volume with mofe'néw patients
`|
`.
`Increase in’Rx,from non-targets
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`42
`
`

`

`
`
`Quantitative Objectives
`
`
`
`ME
`
`-~42-
`
`Dymista
`
`€7000-1Z20XLd
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`43
`
`MEDA_APTX02486050
`
`

`

`Pricing Strategy
`
`*
`
`*
`
`Plan to increase price in January 2015 by 10%
`Current net sales price is $82.20
`
`
`
`ME
`
`-43-
`
`vv000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`44
`
`MEDA_APTX02486051
`
`

`

`
`
`Life
`
`Cycle Management
`
`*
`
`LCM team hasidentified the following three key imperatives:
`
`*
`
`*
`
`*
`
`VMR Indication
`
`Pediatric Indication
`
`QD Dosing
`
`*
`
`building the business case for each (with the exception
`The team will focus on
`of peds) and present to the ET
`
`MED
`
`~44-
`
`a
`Dymista
`
`$7000-1220XLd
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`45
`
`MEDA_APTX02486052
`
`

`

`
`
`Tactical Planning
`
`
`
` drug
`of choice
`|
`. for allergic rhinitis ..
`
`
`PRC
`
`oF
`
`-
`
`2-45
`
`
`
`
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`46
`
`MEDA_APTX02486053
`
`97000-1220X1d
`
`

`

`Drivers of US Field Force Effectiveness
`
`Key
`
`Sales force reach and optimal alignment
`-
`Sufficiently sized to reach a sufficient percentage of the overall prescribers
`-
`Appropriately aligned to target best customers to
`sales force investment
`
`tu
`maximi
`
`
`Sales force influence in
`prescription fulfillment
`~
`Possess effective methods to generate and sustain patient advocacy before purchase
`Able to demonstrate a
`access
`simplified path to product
`by the patient at the pharmacyto prescribing
`customers
`
`-
`
`Sales force training and retention
`-
`access to high potential prescribers
`Able to
`frequently gain
`-
`Trained to deliver a
`distinctly unique and competitive position derived from proven clinical and
`pharmacoeconomical features
`Capable of persuading customers to change prescribing habits
`
`-
`
`MEO
`
`-46-
`
`RYTNST
`Dymista
`
`27000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`47
`
`MEDA_APTX02486054
`
`

`

`Sales Force Key Imperatives
`
`Imperative
`
`by removing rate limiting factors such as pharmacyinterference andd
`1: We must continue to maximize the investment in field sales representatives
`sampling constraints,
`thus expanding call productivity
`
`
`successfully launch Aerospan to the market in a manner that
`Imperative 2: We must
`revenueswithout detracting from Dymista growth potential
`provides favorable Aerospan
`
`Imperative 3: We must achieve an
`appropriate balance of time and resources when
`promoting the respiratory franchise of Dymista and Aerospan within the same customer
`offices
`
`Imperative 4: We must focus on
`our
`retaining and developing
`top talent by identifying top
`mEDe
`talent, understanding risk retention factors, and implementing retention tactics
`wy
`Dymista
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`48
`
`MEDA_APTX02486055
`
`87000-1220X1d
`
`

`

`Target Group Definition, Visit Coverage & Reporting
`*
`are based on the TRx potential for the Branded Nasal
`Spray (BNS) market
`Targets
`Visit Coverage (8.3.1.2):
`
`
`
`
`
`
`
`
`Field Reporting (8.3.1.3):
`*
`All Representative-physician visits are recorded in the Meda MI system whereit
`paxmes tracks visits and samples dropped(if applicable for that visit)
`BesaArleleneaeed
`Dymista
`“ag.
`
`_
`
`67000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`49
`
`MEDA_APTX02486056
`
`

`

`Bow
`eeeee
`
`~
`
`DymistaRefreshedMessaging
`Enjoy the Season”
`Front Cover of Sales Aid
`
`HELP ALLEBGY HATERS
`
`
`ENJOY THE SEASON!
`
`dist
`ttn sell temPBang eoaD et
`ti
`
`-
`
`“HelpAllergyHaters
`
`-
`
`hs
`
`ads
`
`legamretiog:pacw,
`
` gonialGadd tebnsation:
` Pupasewars magetooniasImyacteny,SeenHetonwaHes:TemaoUtINSpireanafel Caeterg
` BE Pah aed
`
`
`
`
`
`BYMISTA
`edobehsobabacs
`.
`seu
`ate
`
`
`6
`
`-49-
`
`0S9000-12Z0X1d
`
`HIGHLY CONFIDENTIAL -
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`50
`
`MEDA_APTX02486057
`
`

`

`Key Marketing
`Si
`
`—
`
`Initiatives
`Sales Force
`He
`pers
`
` MEA
`
`————
`Dyrnista
`
`-
`
`50-
`
`1$000-L2Z0X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`51
`
`MEDA_APTX02486058
`
`

`

`
`
`€9000-1220XLd
`
`i
`
`Key Marketing Initiatives
`
`Sales Force (Cont.)
`
`—-
`
`HEOR data(i-availabl.
`
`Provide details: to non-target:on clinical
`potentially:
`
`MEO
`
`si
`
`Dymista,
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`52
`
`MEDA_APTX02486059
`
`

`

`2015 Sample Allocation
`
`
`
`Assumptions
`*
`out of Goa
`Assumes samples will continue to be shipped
`80 targets each
`Assume 246 territories with approximately
`What happens with AMRs?
`
`*
`
`*
`
`-52-
`
`€$000-L220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`53
`
`MEDA_APTX02486060
`
`

`

`
`
`¥S000-1220X1d
`
`
`
`
`
`
`
`
`
` no
`
`“as
`OMS
`
`ant i
`paakesbr
`
`
`
`Zousabeeasteret6ge
`
`
`spokes
`ITS
`SIGNIFICANT IMPROVEMENT
`
`MAY Had PRED
`
`IOMNARS G2
`aeasnlasy wilh eae
`
`
`
`
`
`
`
`
`eaeaa rotate
`
` IeAKON.tarpybot Thy proce abelFul Creseztetng Kefreceationbr ovat
`oun
`astra
`
`
`Shana swe adititianal
`Inkoraraticen In pecs
`
`lnourtant Saleky frturrtizen heevcaphaust Ibsjalecn aint Full Provurtskeas
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`54
`
`MEDA_APTX02486061
`
`

`

`"KeyMarke‘i
`
`
`agin ‘int
`
`spear
`
`-
`ives
`
`
`
`“al
`
`Dig
`
`soon
`
`$$000-1220X1d
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`55
`
`MEDA_APTX02486062
`
`-
`
`~
`
`84
`
`
`
`

`

`
`
`
`
`9$000-1220X1d
`
`Key Marketing Initiatives
`
`—
`
`
`
`Media
`
`Social
`
` -Sneezecast YouTube
`
`=
`
`oe =
`
`
`
`
`
`to the
`misery caused by”
`v iceviicrosite. speaking
`©
`“+ ©
`as an issue that should be taken
`allergies
`Raisesallergies
`,
`seriously
`Givesallergy sufferers a
`
`voice
`
`unified
`
`.
`
`2 0).
`| Unbranded microsite,
`
`+; “SAR Sufferers.
`+
`Sneezecast.Twitter
`to the misery
`. Do.
`.
`.
`a
`:
`:
`no
`Bo,
`eee
`BAe
`speaking
`.
`
`Raisas allergies as an
`allergies
`be
`issue that should
`a
`
`voice
`taken seriously
`Gives
`
`allergy sufferers.
`‘unified
`
`Placed on
`déd
`‘Banfer:ads ©”
`
`
`
`consumer
` ellerpy.
`sneezecast:
`
`ps
`pages
`
`to
`
`‘ra
`
`Guise
`
`ca used
`
`
`iy
`
`.
`
`:
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`56
`
`MEDA_APTX02486063
`
`

`

`_
`
`MarketingInitiatives
`Management
`
`-
`
`Advocacy/OpinionLeader”
`
` HIGHLY CONFIDENTIAL-
`
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`SUBJECT TO STIPULATED PROTECTIVE ORDER
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`87
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`227
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`HIGHLY CONFIDENTIAL-
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`
`58
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`MEDA_APTX02486065
`
`

`

`
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`
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`
`
`
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`
`MEDA_APTX02486066
`
`HIGHLY CONFIDENTIAL -
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`
`59
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`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`60
`
`MEDA_APTX02486067
`
`

`

`-9000-1220X1d HIGHLY CONFIDENTIAL -
`
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`61
`
`MEDA_APTX02486068
`
`

`

`-
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`A
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`29000-L2Z0X1d
`
` HIGHLY CONFIDENTIAL
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`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`62
`
`MEDA_APTX02486069
`
`

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`providers.”
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`€9000-1220X1d HIGHLY CONFIDENTIAL-
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`
`63
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`MEDA_APTX02486070
`
`

`

`Key Marketing Initiatives
`sees
`
`Sales Operations
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`—-
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` MESA
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`Dymista
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`HIGHLY CONFIDENTIAL -
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`64
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`MEDA_APTX02486071
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`¥9000-1220X1d
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`HIGHLY CONFIDENTIAL-
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`65
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`MEDA_APTX02486072
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`Financials
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`of choice
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`HIGHLY CONFIDENTIAL-
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`66
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`MEDA_APTX02486073
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`Budget
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`Allocation & Goals
`A&P $26 MUSD
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`Net Sales Goal: $ 97 MUSD
`
`TRx Goal: 1.16M
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`Exit Market Share Goal: 6.1%
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`Exit Branded Share Goal: 27.4%
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`HIGHLY CONFIDENTIAL-
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`67
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`MEDA_APTX02486074
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`eoere
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`Dymista
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`HIGHLY CONFIDENTIAL-
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`68
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`MEDA_APTX02486075
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`

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