PTX0438-00001
`
`
`
`i
`
`
`
`qi1Cyn
`
`temmmermeeneenn Marketing Plan 2015
`
`OyRanaeaste
`HECHT
`
`
`
`-
`-
`
`drug of choice
`for allergic rhinitis
`
`MEDA
`
`=
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`CIP2093
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`MEDA_APTX03501812
`
`
`
`
`
`
`
`i
`
`
`
`qi1Cyn
`
`temmmermeeneenn Marketing Plan 2015
`
`OyRanaeaste
`HECHT
`
`
`
`-
`-
`
`drug of choice
`for allergic rhinitis
`
`MEDA
`
`=
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`CIP2093
`Argentum Pharmaceuticals LLC v. Cipla Ltd.
`IPR2017-00807
`
`MEDA_APTX03501812
`
`
`
`
`
`Marketing Plan 2015
`
`2012a«
`
`PTX0438-00002
`
`eu Eee es
`
`Senembenat
`
`ee
`2 Re ee ie
`
` Mean
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03501813
`
`
`
`PTX0438-00003
`
`Content
`
`*
`
`*
`
`*
`
`*
`
`*
`
`*
`
`*
`
`¢
`
`*
`
`Product Profile
`
`Disease State
`
`Market Dynamics
`Competitive Environment
`
`Product Dynamics
`SWOT Analysis
`
`Key Issues/Strategic Planning
`
`Sales Force
`
`Tactical Planning
`Financials
`
`Mean
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03501814
`
`
`
`*
`+
`*
`*
`*
`
`PTX0438-00004
`
`Product Profile
`*
`Trade Name: Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray 137mcg/50mcg per
`Spray
`Launch Date: September 24, 2012
`Patent Protection: 2026
`Substance Class: Nasal Spray
`Active Ingredients: azelastine hydrochloride/fluticasone propionate
`Indication: Seasonal Allergic Rhinitis (SAR) for patients 12 years and older who require treatment with both
`azelastine hydrochloride and fluticasone propionate for symptomatic relief
`Dosage: 1 spray/nostril 2x daily
`Packsize: 23 grams netfill (120 metered sprays)
`Prices: $145.95 (wholesale acquisition cost); $82.20 (net price); most patients pay aslittle 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-
`
`MeEDa
`
`
`2015
`32%!
`26%
`12%
`30%
`
`ee
`PA= Prior Authorization
`:
`‘First half of 2015 prior to Nasonexgeneric
`SE= Step Edit
`Dymista
`2Notlisted refers to a databaselimitation; assume Tier 3
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`4
`
`MEDA_APTX03501815
`
`
`
`=
`
`q
`:
`F
`
`:
`
`;
`Be
`E
`
`PTX0438-00005
`
`Disease State
`
`
`
`Syenmtrensda}
`
` drug of choice
`f
` for
`
`allergic
`
`rhinitis
`
`_
`
`
`Mane
`
`
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`5
`
`MEDA_APTX03501816
`
`
`
`PTX0438-00006
`
`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
`becomeinflamed which manifests nasal symptoms such as
`running nose, nasal
`and nasal itching.
`congestion, sneezing
`
`to DataMonitor, it is estimated that between 40-60 million
`According
`rhinitis
`United States suffer from allergic
`
`people
`
`in the
`
`and treat through over-the-
`Patients often self-diagnose based on their symptoms
`often use
`counter
`however,it is noted that
`(OTC) options,
`patients
`multiple
`medications to control their symptoms and costs are substantial
`
`to a
`Marple and
`Colleagues Study, many patients
`According
`ofrelief they offer
`treatment options and the type
`
`are confused by
`
`the
`
`
`
`aie
`
`-6-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`6
`
`MEDA_APTX03501817
`
`
`
`PTX0438-00007
`
`Diagnosis and Treatment
`
`¢
`
`*
`
`*
`
`Primary Care Physicians, Otolaryngologists (ENTs), and Allergists
`commonly treat SAR
`
`most
`
`Physicians
`
`often
`
`diagnose SAR when
`
`treating
`
`other ailments such as asthma
`
`intervention tend to have more severe
`Patients that seek
`physician
`which combination therapyis often prescribed
`
`symptoms for
`
`Mmepa
`
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`7
`
`MEDA_APTX03501818
`
`
`
`Conclusions
`¢
`It has been documentedthat 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
`
`PTX0438-00008
`
`¢«
`
`¢
`
`Mmepa
`
`
`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
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`8
`
`MEDA_APTX03501819
`
`
`
`PTX0438-00009
`
`
`
`Market Dynamics
`
`soneeNRe SBE
`
`
`
` drug of choice
`
`iLENE
`
`-
`
`=
`for allergic rhinitis =
`
`MEepPA
`
`-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`g
`
`MEDA_APTX03501820
`
`
`
`-
`
`Market Dynamics
`Market
`¢
`MarketClassification: Allergic Rhinitis (Seasonal and Perennial)
`
`Market Classification & Relevant
`
`PTX0438-00010
`
`*
`
`*«
`
`SecPa
`
`
`$3.43 billion’ (gross sales);
`
`Allergic Rhinitis Nasal Spray Marketis a
`56 million’ TRxs
`—
`Generic Nasal Sprays Represents
`*
`$1.46Bdollars’
`*«
`80% of TRx Business
`*
`Fluticasone Propionate largest generic (41 million TRx)?
`Branded Nasal
`Sprays Represents
`*
`$1.98B dollars’
`*
`20% of TRx Business
`*
`Inhaled nasal steroid (INS): Nasonex largest INS brand representing $1.35B (~$600 MUSD net
`2
`sales)
`
`-
`
`Managed Care coverage drives performance:
`+
`INS: generic Flonase Tier 1; Nasonex preferred Tier 2 (75% of coveredlives)
`*
`Statuslikely to change based on flonase going over the counter
`Generics will cover 70-90% ofpatient lives
`Source: SymphonyHealth, TR- Aug. ‘14
`
`*
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`10
`
`MEDA_APTX03501821
`
`
`
`
`
`PTX0438-00011
`
`Quantitative Development
`—
`Nasal
`Market
`Spray
`TRx up ~6% over
`2013; $3.4B in Value
`
`50,000,000
`
`Nasal Spray TRx
`penneeene
`
`|
`
`Nasal Spray MBS $5(nitions)
`
`po
`
`50,000,000
`
`|--yayy
`
`40,000,000
`
`30,000,000
`
`20,000,000}
`
`
`
`+-
`
`$3,500
`
`$3,000
`
`$2,500
`
`
`
`«2008
`
`2011
`«2010S
`«62009
`®TRx (proj) @ TRx
`
`2012-2013.
`
`2014
`
`2007
`
`2008
`
`2011
`2010
`2009
`#2 MBS $$ (proj} = MBS $$
`
`2012
`
`2013
`
`2014
`
`
`
`
` 2007.
`10,000,000
`
`
`
`3232 CAGR=compoundannualgrowthrate
`
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`1
`
`MEDA_APTX03501822
`
`
`
`NRx Market Share
`Branded Nasal Spray
`- nn
`12%
`
`heINRmR einen eminem mimerm emma
`
`
`
`
`pantttt
`
`10%
`
`8%
`
`
`
`
`
`
`
`PTX0438-00012
`
` 0%
`
`-es
`Oct'l13 Nov'l3 Dec'l3
`Jan'l4
`
`Feb'14 Mar'l4 Apr'l4 May'14 Jun'l4
`
`Jul'l4 Aug'l4 Sep'l4 Oct '14
`
`
`
`«acpden PATANASE
`«mg==ASTEPRO
`DYMISTA
`
`
`soousee
`emiVERAMYST
`=aQNASL
`All Other Branded
`Of note, Nasonex remains mostly flat at 68%-70% market share
`
`negoOMINARIS
`consiTETONNA
`
`Coenen
`enna
`Dymista
`
`Neapa
`
`Source: SymphonyHealth, TR
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`12
`
`MEDA_APTX03501823
`
`
`
`Method of Payment
`
`PTX0438-00013
`
`BRAND
`
`NASONEX
`
`Pr
`
`eon
`
`ee
`
`zs
`ms
`
`ei
`
`
`
`ERAMYST
`
`
`
`i
`
`*
`
`Seon
`
`
`Majority of branded competitors get business from managed care/3" party
`*
`IfNasonex goes OTC, 89% of TRxs come from managed care, and has a has major
`snema
`on branded & Dymista business
`-
`impact
`Source: Symphony Health
`PHAST National Database— July ‘14
`-13-
`a.
`are
`13
`Total Third: Third Party/Commercial insurance
`
`Dymista
`aM
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`13
`
`MEDA_APTX03501824
`
`
`
`Nasal
`
`Spray Payment Type Mix
`
`(2014 YTD)
`
`MEDICARE PART D
`18%
`
`ASSISTANCE
`PROGRAMS
`2%
`
`CASH PAYMENT
`4%
`
`MEDICAID PAYMENT
`5%
`
`MANAGED
`MEDICAID PAYMENT
`7%
`
`
`
`Epa
`
`
`Commercial and Medicare Part D represent 82% of Nasal Spray TRx
`
`PTX0438-00014
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`14
`
`MEDA_APTX03501825
`
`
`
`PTX0438-00015
`
`-
`
`60.40%
`
`% Commercial
`
`
`-
`
`
`
`Medicaid
`
`10.37%
`
`-
`
`9.31%
`
`Managed Medicaid
`#@ Medicare Part D- 11.17%
`-
`
`m=
`
`
`ft Uninsured
`
`8.75%
`
`US Population by Payer Segment
`
`316,128,639 Lives
`
`27,647,239
`
`35,323,700
`
`29,433,600
`
`
` 32,782,000
`
`90% discount required to belisted in Medicaid and Managed
`Medicaid -> not a
`target for Dymista
`
`MEPa
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`15
`
`MEDA_APTX03501826
`
`
`
`Dymista Commercial and Medicare Part D
`=
`
`Dymista Total Unrestricted Lives
`15,542,42
`
`126,288,962
`
`# Unrestricted Commercial
`
`-
`
`58%
`
`PTX0438-00016
`
`44% 110,746,534
`
`Source: Managed MarketsInsights and Technologies October 2014
`Mmepa
`
`
`@ Unrestricted Medicare Part D
`
`-
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`16
`
`MEDA_APTX03501827
`
`
`
`Taking Advantage of Nasonex Shift
`
`PTX0438-00017
`
`
`or OTC, there will be additional opportunity for
`When Nasonex goes generic
`Dymista
`with Caremark for Tier 2 Preferred position
`
`*
`
`*
`
`*
`
`place
`
`Contract proposal in
`the category
`to be the Preferred brand when Nasonex goes
`Contract discussions have taken
`place
`Generic or OTC ( e.g.: Prime Therapeutics)
`Continued discussions to determine what planswill re-bid the category and when
`
`when
`
`they re-bid
`
`Mmepa
`
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`17
`
`MEDA_APTX03501828
`
`
`
`Dymista Top Plan Formulary Positions
`
`
`PTX0438-00018
`
`
`Commercial
`Position
`Lives
`
`NDC Blocked in 60%
`Caremark
`40,000,000
`
`Tier 3 unrestricted
`Express Scripts / Medco
`39,000,000
`
`ESI Basic and National Preferred
`Tier 2 Preferred
`23,000,000
`
`Tier 3 unrestricted
`Prime Therapeutics
`17,000,000
`
`Tier 2 Preferred
`nthem WellPoint
`14,000,000
`
`United Healthcare
`NDC Blocked
`14,000,000
`
`etna
`Tier 3 unrestricted
`8,400,000
`
`Tier 3 unrestricted
`6,500,000
`Cigna
`
`Tier 2 Preferred
`Humana
`2,700,000
`Tier 2 Preferred
`Harvard Pilgrim
`1,100,000
`
`Medicare Part D
`Position
`Lives
`
`Preferred
`8,100,000
`Express Scripts
`
`ARP (OptumRx)
`Preferred
`6,700,000
`Humana
`Preferred
`5,100,000
`CIGNA Part D
`Preferred
`860,000
`
`
`
`
`
`
`
`MEeDa
`
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`18
`
`MEDA_APTX03501829
`
`
`
`Dymista Access Trends
`Commercial and Medicare Part D Trends
`
`70% +
`
`60% +>
`
`50%
`
`+
`
`PTX0438-00019
`
`% Lives
`
`40%
`|
`-
`
`30%
`
`|
`
`20%
`
`10%
`
`0%
`
`Neapa
`
`
`
`;
`
`April 2013
`
`April 2014 October 2014
`
`2015
`
`Projected
`
`.
`.
`= Commercial Unrestricted Access
`
`@ Medicare Part D Unrestricted
`Access
`
`ee
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`19
`
`MEDA_APTX03501830
`
`
`
`Dymista Manage Care Coverage Comparable to New
`RNR RRRAHR
`2 RAE ANE ees
`Competitors
`|
`
`EN
`
`ENA
`
`NORCO
`
`H|
`
`80%
`70%
`
`PTX0438-00020
`
`
`
`eae
`ee
`=Nasonex® = & § =Qmnaris® === Patanase=
`=Zetonna
`Bea ee seek 2S 2S 8 BB Sebo:
`aEF
`Qnask-Veramyst
`Seeaearache
`Se Se caraSoy NEE
`Eg
`QB72 22 am
`oe
`SEE: SOE SR SSE RNMR A OH AAAS NASALPSPSTSEae SE
`|
`oi Restricted(PA/ST) =NotCovered”&NotListed
`28 Covered
`
`Formulary Definitions
`formulary; often results in a lowest brand copay to patients
`on
`Preferred: Brand is preferred
`Covered: Often the second lowest brand copay to patients
`Restricted: Drug is not suggestedforfirst-line therapy, often requires PA (prior approval) ora SE
`(step-edit)
`©3202 Not Covered: Drug is not covered on formulary
`
`Not Listed: Data baselimitation; assumerestricted tier
`
`Source: MMIT
`
`ae
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`20
`
`MEDA_APTX03501831
`
`
`
`TRxs Covered by Payer Type
`
`Nasal
`
`Spray
`
`Market
`
`-
`
`Nasal Spray Market
`
`2%
`
`Dymista
`
`PTX0438-00021
`
`
`
`
`
`
`ASSISTANCE PROGRAMS
`
`& CASH
`
`sf! COMMERCIAL
`
`= MEDICARE
`
`& MANAGED MEDICAID @ MEDICAID
`
`-21-
`
`Source: Symphony Health
`
`-
`
`PHAST National Database
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`21
`
`MEDA_APTX03501832
`
`
`
`Commercial Claims
`
`
`
`Filled Claims
`Reversed Claims
`Rejected Claims
`Branded Product
`ASTEPRO 0.15%
`77%
`
`DYMISTA
`67%
`NASONEX
`74%
`12%
`74%
`OMNARIS
`PATANASE
`6%
`20%
`74%
`
`
`RHINOCORT/AQUA
`
`72%
`
`14%
`
`14%
`
`
`
`
`
`
`
`
`
`
`
`
`
`ZETONNA
`Generic Product
`
`72%
`
`FLUTICASONE
`TRIAMCINOLONE ACET.
`All Products
`
`NASAL SPRAY MKT 5% 85% 10%
`
`Fill Rate= Prescription is filled
`Reversal Rate= Script was approved butfor various reasons neverfilled
`Rejection Rate= Script was not approved
`-
`Source: Symphony Health
`
`82%
`
`12%
`
`
`
`6%
`
`Seo
`
`
`29
`
`PHAST National Database
`
`
`
`PTX0438-00022
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`22
`
`MEDA_APTX03501833
`
`
`
`
`
`PTX0438-00023
`
`g3,%a
`
`Competitive
`
`Environment
`
`
`
`MEDA
`
`Le&=oa
`drug of choice |
`
`
`—
`-
`for allergic rhinitis
`
`=aa=
`=aaaae=Fak——aa=aa===eT=
`
`== =
`
`23-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`23
`
`MEDA_APTX03501834
`
`
`
`Competitive Environment
`
`¢
`
`Branded nasal spray market contains 19 brands, main
`—
`
`competitors
`
`are:
`
`Nasonex
`
`-OTC’s
`-
`
`Qnasl
`2014 TRx Market Share Snapshot(10/2014):
`
`PTX0438-00024
`
` meDa
`
`-24-
`
`:
`
`Source: Symphony Health
`
`-
`
`Dymista
`PHAST National Database
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`24
`
`MEDA_APTX03501835
`
`
`
`PTX0438-00025
`
`Update to Nasacort24 Over-the-Counter
`
`9.9 MM units
`for 2014
`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
`
`Mean
`
`-25
`
`-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`25
`
`MEDA_APTX03501836
`
`
`
`OTC Digital Presenceis
`
`Climbing
`
`continuesto climb and be more
`OTC category spend
`aggressive
`had the strongest OTC digital presence in 2013
`Zyrtec
`Zyrtec spent almost $11mm in digital spend in 2013
`Claritin maintains the second largest OTC presence with over
`
`$4mm in spend
`
`PTX0438-00026
`
`OTC Search Landscape
`
`$696,000.00
`
`
`
`a Nasacort
`Advil AHergy
`@ Allegra
`fa Claritin
`w@ Zyrtec
`
`
`
`
`= Allegra
`8 Claritin
`@ Zyrtec
`
`Source: Kantar 2013 Mean
`
`-
`
`-
`
`26
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`26
`
`MEDA_APTX03501837
`
`
`
`Allergy Search Landscape
`
`*
`
`One Playing
`
`Field For All OTC, DTC Across Same Keywords
`
`Web
`
`
`Shegping
`
`images
`
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`Aboul 2,89(,,090 resulig (0.30 seconds)
`
`Nasacon® OTC Nasal Spray
`Ee) WW.NeBacor.com7
`Gel zd HR Refiel For four Hasal Allergy. Sign Uo NowTo Savel
`
`
`
`Nasacert (OTC)
`
`PTX0438-00027
`
`Sinus Allergy Congestion
`*
`ces) wevw.clartin.com/
`-
`Allergies vs. Cold
`Allergy Types & Tips
`
`-
`
`Claritin (OTC)
`
`-
`
`HCPs: Get Info
`
`Charitin-D@ Guarariee
`
`Clartin-D@ Provides Non-Drowsy Prescaptian Sirangth Ralief. Nasal Allergy Spray
`
`~
`ES] waw.morecompletealiergyrelieicony
`Dymista [Rx]
`See if You Qualify for A Go-Pay Gard Discount on an Slergy Spray
`-
`Enroll For A Co-Pay Card
`About Dymista Nasal Sporay- HCP Official Site
`
`Mean
`
`-
`
`-27
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`27
`
`MEDA_APTX03501838
`
`
`
`3ie
`hy
`
`PTX0438-00028
`
`Respiratory
`
`Market
`
`Key
`
`Events 2015
`
`i
`
`
`
`re
`
`
`
`Flonase OTC
`Generic fluticasone (currently 78% of the total prescription
`10
`market) may be removed on many,if not all, formularies
`
`p{
`
`
`
`bh
`
`Qnasl
`
`Pediatric Indication
`
`|
`
`clean
`bed
`nibbled
`Co
`kaAdres
`
`
`Pediatricians awareness ofthe nasal spray market anid the
`benefits they provide will increase as Teva increases promotion,
`an
`awareness for
`opportunity for Dymista to leverage
`providing
`its own
`pediatric indication launch in 2015
`¢
`i Dymista Pediatric
`10-30.
`:
`*
`Indication
`
`peat
`
`Improved formulary opportunity
`Indication is competitive with other nasal sprays
`ls,
`oeeI :
`ao
`
`dee
`
`Nasonex OTC or
`
`generic
`
`¢
`*
`
`¢
`
`Increased share of voice for Dymista in the branded market
`Improved formulary opportunity, replacing Nasonexas
`preferred brand for managed health care organizations
`|
`Dymista will be the leading Rx drug in the category
`|
`:
`iL
`i
`
` -
`-
`-
`28
`
`20-30
`
`|
`i
`|
`
`'
`ie
`i
`FE
`'
`
`I
`ff
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`28
`
`MEDA_APTX03501839
`
`
`
`Qualitative
`
`Dynamics
`
`-
`
`Most Relevant Competitors
`
`PTX0438-00029
`
` >
`
`suggests ease to consumers
`:
`
`—
`
`* No physician guidance
`patients can take the
`wrongtype of med
`+
`Expectations are notlevel set— can lead to
`dissatisfaction, discontinuation
`
`s
`
`*
`*
`*
`
`ac
`
`to consumers
`accessible
`Easily
`Low cost
`No doctorvisit or script
`Brand awareness
`High advertising spend
`
`oe
`
` *
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`29
`
`MEDA_APTX03501840
`
`
`
`Market Dynamics
`*
`
`-—
`
`Conclusions
`
`PTX0438-00030
`
`Overall Nasal
`
`Spray
`
`Market is
`
`growing
`
`due to
`
`generics
`
`at 6%; branded market
`
`has declined 13.1%
`
`Managed Care Formulary Coverage has major impact
`being filled
`
`on Brand Prescription
`
`*
`
`*
`
`*
`
`2015 there will be approximately 56 million Rxs of Allergic Rhinitis
`-
`no market changes); 11.2M TRxs
`no market
`
`~20% will be branded (if
`
`—
`
`~80% would be generic (if
`
`changes); 44.8M TRxs
`
`Market
`
`changes
`
`are
`
`planned whichwill impact the branded Rx market:
`
`Major
`—
`
`—
`
`EDA
`
`
`Flonase OTC launchin January 2015
`
`Nasonex goes Generic or OTC
`20
`
`A
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`30
`
`MEDA_APTX03501841
`
`
`
`eS
`a
`tai
`
`=
`:
`a
`
`PTX0438-00031
`
`Product Dynamics
`
`drug of choice i
`
`for
`
`allergic
`
`rhinitis
`
`|
`
`i
`j
`
`31
`
`MEDA_APTX03501842
`
`s
`
`jytnrmerensda}
`
`a1
`
`=e
`
`
`
` _
`
`mMeEDe
`
`|
` 73t-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`Patient Insights
`
`PTX0438-00032
`
`«
`
`¢
`
`«
`
`Patients need to feel absolutely miserable before they will go to a HCP for
`
`intervention
`-
`
`Patients do not view allergy
`
`as a serious enough illness to seek physician intervention
`
`Patients often
`
`cycle through home remedies and OTCs- theseactions are often
`a TV ad
`based on the recommendationsof friends or
`
`prompted by
`now consists of 8 steps and can take several
`The Patient Buying Processfor allergies
`seasonsor
`years for patients to cycle through
`
`Mmepa
`
`
`2
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`32
`
`MEDA_APTX03501843
`
`
`
`Patient Insights
`*
`Patients are
`negative regarding their allergies and symptom relief
`
`Top Topics in
`Messages aboutAllergies by Sentiment
`—
`January 1, 2013
`May 31, 2014
`i Neutral
`@ Negative
`& Positive
`
`Symptoms
`
`Allergy Trigger
`
`Medication Efficacy
`
`PTX0438-00033
`
`Lifestyle Impact
`
`General Mention
`
`OTC vs. RX
`
`HCPInteraction Diagnosis
`
`Mean
`
`-
`
`-
`
`33
`
`0% 5% 10% 15% 20% 25% 30% 35% 40% 45%
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`33
`
`MEDA_APTX03501844
`
`
`
`PTX0438-00034
`
`Physician Insights
`
`¢
`
`«
`
`*
`
`¢
`
`*
`
`¢
`
`Allergists tend to position Dymista at the end of the treatmentalgorithm
`-
`
`Step-up training
`
`ENTs tend to move more
`
`quickly toward
`Dymista
`Cost/hassle factor seems to take precedencein positioning
`or other outcomes measures
`
`Primary Care Physicians have low awarenessfor Dymista
`HCPs focus on
`
`Dymista componentsinstead of benefits
`
`over
`
`patient satisfaction
`
`Physicians realize that they need to demonstrate value to their allergy patient
`
`¢
`MlDe
`
`
`are
`losing their business to OTCs
`Physicians realize that they
`MarketSizing Study 3/13 & Converseon Social Listening Study 6/14
`34
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`34
`
`MEDA_APTX03501845
`
`
`
`PTX0438-00035
`
`Product Dynamics
`*
`As of July 2014, ENTs contributed 29% of Dymista
`allergists contributed 27% (n=11,101) and primary
`(n=11,827)
`
`NRx volume (n=11,827),
`care contributed 29%
`
`*
`
`Achievements
`Major Marketing
`(4.2)
`-
`Since its launch, Dymista has increased TRx market share in the branded nasal spray
`(BNS) market andis 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
`
`Mmepa
`
`
`45
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`35
`
`MEDA_APTX03501846
`
`
`
`PTX0438-00036
`
`Conclusions
`
`Exploit the misery of the allergy patients and give them a unified voice
`Continue to build upon the successof the sales team
`
`Leverage KOL advocacyto continue to build brand loyalty and
`
`recognition
`
`Increase managed
`
`care access and reduce pharmacyswitching
`
`¢
`
`*
`
`Mmepa
`
`
`46
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`36
`
`MEDA_APTX03501847
`
`
`
`PTX0438-00037
`
`SWOTAnalysis
`
` drug of choice
`
`for allergic rhinitis
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`ME
`
`a=
`
`4
`
`’
`
`’
`
`w“J
`
`
`
`37
`
`MEDA_APTX03501848
`
`
`
`PTX0438-00038
`
`Dymista SWOT Analysis
`Strengths
`
`Superior efficacy
`Rapid onset of action with inflammation control with unique
`delivery system and fine mist spray
`—
`one in the market
`Uniquenessof product
`the only
`Safety profile
`
`Opportunities
`Patients and Physiciansstill feel unmet need in seasonal
`—
`allergy products
`Dymista opportunity
`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
`
`+
`.
`
`+
`¢
`
`«
`
`«
`
`+
`
`«
`
`Weaknesses
`Nasal spray delivery is viewed as cumbersometo patients
`Sales force reach/frequency
`Narrowindication (lack of PAR, ocular, & ped)
`Lack of resourcesfor pull through
`
`Threats
`Majority of nasal spray marketis 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 mayno longer
`cover brands
`Access declines to less than 58% oflives
`Low consumer awareness
`
`Mean
`
`-
`
`-
`
`38
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`MEDA_APTX03501849
`
`
`
`Conclusions from SWOT
`
`—
`
`the only “One”in the market
`Dymista is unique
`Dymista has a clinical difference with
`and speed of onset
`efficacy
`care
`To achieve 2015 sales
`coverage withoutrestrictions will be
`critical
`
`goals, managed
`
`Plan to focus on
`
`patients through digital
`
`in 2015; still unmet need in Seasonal
`
`PTX0438-00039
`
`Allergy products
`market
`-
`
`Major
`OTC impact
`dissatisfaction
`
`continue to impact branded Rx market
`changes
`come back due to
`patients may leave Rx market, but many may
`—
`
`«
`
`*
`
`*
`
`¢
`
`*
`
`*
`
`*
`
`+
`
`Generic Nasonex
`physicians and patients may opt for lower priced productthatis
`Tier 1 for
`formulary coverage
`Managedcare organizations may abandon second tier category for allergic rhinitis
`Mmepa
`Dymista
`
`
`40
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`39
`
`MEDA_APTX03501850
`
`
`
`
`
`Key Issues
`Strategic Planning
`
`PTX0438-00040
`
`
`
`
`
`allergic
`
`rhinitis
`
`|
`—
`
`PERS
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`40
`
`MEDA_APTX03501851
`
`drug of choice
`
`or
`
`
`
`
`
`Key issues
`
`PTX0438-00041
`
`is grouped into a branded marketthat is
`
`2)
`
`declining, though Dymista
`
`is
`
`1) Dymista
`not
`SARsufferers minimize their suffering and don’t see the doctor until their misery
`is intolerable
`3) Brand awarenessis low among non-targets and consumers
`4) Sales force reachis limited due to size and priority focus
`change formulary- out of our control
`5) Managed Careis reluctant to
`
`Mmepa
`
`
`4
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`I
`
`MEDA_APTX03501852
`
`
`
`Dymista Strategic Map
`
`PTX0438-00042
`
`
`Brand awarenessis low
`
`grouped intoa’
`among non-targets and
`
`arket that is
`consumers
`
`
`We)ei (ted(aeae
`=
`
`Increase brand awareness,
`
`Drivetincreasein
`
`brand name requests &
`Drive patients toseeks
`
`
`Rxfulfillments
`
`physician willingness to
`physician/pharmacis
`
`intervention sooner
`
`prescribe
`|
`at
`
`BaPee eeeeee
`55ii;ii::éti
`
`
`
`
`... EngageSAR Sufferers.
`DTP/DTCvia digital and
`‘newclinicaldata,
`Leverage
`via Multi-Channel
`engage PCPs through
`to distinguish Dymista from |
`
`conventions anddigital
`the
`OTC/generic market (MP
`Promotion (DTP/DTC)
`means
`001)
`|
`
`
`:i4
`
`sound approach
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`42
`
`MEDA_APTX03501853
`
`
`Managed Careis reluctant to
`
`
`change formulary- out of our
`control
`
`:
`'
`
`|:
`
`
`
`
`
`PTX0438-00043
`
`
`Managed.Careis reluctant.
`to change formulary- out
`
`control
`
`|
`
`|||
`
` i
` t
`
`ormpassResearch
`PDQ emails/cocps
`
`Convention presence
`Producttheaters
`
`° *
`
`oe
`
`
`2015 Major Initiatives Aligned to Strategies
`
`
`
`
`
`
`
`Dymistais
`grouped intoa
`thatis
`market
`
`
`
` rograms (virtual
`
`j
`
`»{|»;
`i|
`
`iei|||\|\|i|||||ij\
`
`:
`:
`i
`3
`:
`
`
`
`
`
`
`
`Brand awarenessis low
`
`_
`Sales force reach is
`SAR sufferers:minimize
`
`limited due to size and
`among non-targets and
`
`
`their suffering and don’t
`
`
`consumers
`priority focus
`
`
`
`
`:|
` pecad
`
`si|eii
`“
`H
`Targeted e-mail campaign|
`iea i
`Banner ads
`iiiii:
`Communication Portal
`Paid Search
`E-mails to consumers
`-Promote MP4601 _.
`Enhanced product sites
`E-details
`;|~
`
`CRM campaign
`MP4001 promotion
`
`Promote HEOR data
`|.ii>ii.:\*|
`|
`* =Promotional Materials...
`*
`HEORdata promotion
`Convention presence
`e
`Fundsto
`Banner ads
`Product Theaters
`“Luneh'SiCearn
`"+"1
`Paid search
`Communication Portal
`digital promotion:
`
`
`engage physicians—:
`_
`Enhanced websites
`
`More focused education.
`Geo-targeted heavy-ups
`i
`Dymista.com (ask an
`Virtual speaker programs
`eted
`e-mail campaigni
`
`expert)
`| * Ask anAllergist on the
`from pharmacy database
`boards
`Advi
`sory
`Sneezecast microsite
`_Competitive copay
`Make Dymista the Expert
`|.
`Physicianoffices: Patient
`i
`campaign
`i :
`program
`| materiais, samples and
`
`access copay card
`|
`|
`|
`if
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`43
`
`MEDA_APTX03501854
`
`
`
`Over-the-Top Initiatives
`
`PTX0438-00044
`
` AAFA
`
`.
`¢«
`
`Use our social media
`to promote
`ng
`Allergy
`Spri
`seen
`‘Targeted tweets and posts to different geographic users
`
`Capitals
`
`A
`
`Spring Capitals
`Sponsorship
`
`Consumer
`
`LRG Ase
`Ee Re
`
`
`SeTSSae 2a
`
`eesaree
`=
`
`peshaelebebencia
`*
`
`In-office TV {news program) on allergies and
`Consumers
`GannettIn-Office
`Dymista
`promoting
`Awareness
`
`MeDpa
`
`
`-
`
`-
`
`44
`
`eaten
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`44
`
`MEDA_APTX03501855
`
`
`
`Qualitative Objectives
`of
`
`
`
`rided
`
`
`
`PTX0438-00045
`
`
`
`‘
`
`Drive patients to seek physician/pharmacist Intervention
`sooner
`
`4
`
`Increased TRxs & sales manth-over-month
`*
`Increase in script volume with more new patients
`‘
`Digital downloads of Access Copay Card
`Increase in redemption of copay card
`Dymista.com increasedtraffic
`iqueproduct thatcan be usedinmajority ofpatients.
`
`
`3
`
`__
`types
`
`
`_
`natioi
`Feedback
`PlacementbyPractice Param,
`
`
`Brand
`
`
`
`awareness stud
` Increase in script volume with more new patients
`
`—
`Increase in Rx from non-targets
`
`Digital downloads ofAccess Copay Card
`Increase in redemption of copay.card
`Dymista.com increasedtraffic
`
`.
`
`
`
`
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`45
`
`MEDA_APTX03501856
`
`€
`
`
`Quantitative Objectives
`
`PTX0438-00046
`
`
`
`=
`
` Sam
`
`
`
`RR
`reap |
`ce a
`
`ner
`Total M
`-
`ee
`3H of
`SeemeteoemARIRENRNR SERS
`a8 ew deen
`SESS RTAT EBON TM IT
`
`sameeren
`f
`a
`:
`;
`a:
`ay
`gea
`aaa aaa ea eaRTT
`me
`wanea (EEDSRERERED
`
`ually
`BAAEES
`TBD: secu wa2seceeves
`Oooo
`ES
`FBD
`onmanionean oe
`TOCDSIIG Le ae geseen epeeeens
`‘Brande.
`"Af i oe SoreEER
`REET EEREEEETERSRENER
`ce
`QeaEEEEer CREEES EARSEOE
`2agiiiitsCe ee
`
`=
`
`—_
`
`f
`
`ou
`
`*Reflects launch in September 2012
`
`Mmepa
`
`
`‘6
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`46
`
`MEDA_APTX03501857
`
`
`
`Pricing Strategy
`
`Current WACis $145.95
`
`Current net sales price is $82.20
`Plan to increaseprice in
`
`January 2015 by 10%
`
`*
`
`*
`
`¢
`
`PTX0438-00047
`
`Mean
`
`-
`
`-47
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`47
`
`MEDA_APTX03501858
`
`
`
`PTX0438-00048
`
`Life Cycle Management
`
`LCM team hasidentified the following three key imperatives:
`
`*
`
`*
`
`*
`
`VMR Indication
`
`Pediatric Indication
`
`QD Dosing
`
`The team will focus on
`building
`peds) and present to the ET
`
`the business case for each (with the exception
`
`*
`
`*
`
`of
`
`Mmepa
`
`
`‘ts
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`48
`
`MEDA_APTX03501859
`
`
`
`Effectiveness
`
`yierens
`
`
`drug of choice |
`
`
`rhinitis
`for
`allergic
`—
`
`_
`
`_
`
`PTX0438-00049
`
`-
`
`.
`
`Sales Force 2015 Goals,
`imperatives, and
`Drivers of
`
`Key
`
`
`
`Mane
`
`ae
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`
`
`49
`
`MEDA_APTX03501860
`
`
`
`2015 US Sales Force Goals
`
`*
`
`—
`
`Dymista Sales
`-
`Q1 Milestone: Mitigate lost volume resulting from Humana and Aetna formulary removal
`
`2015 exit market share of 2.4%
`
`PTX0438-00050
`
`Mmepa
`
`
`50
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`50
`
`MEDA_APTX03501861
`
`
`
`Key Drivers of US Field Force Effectiveness
`
`Sales Force Alignment and Multi-functional Promotional /Educational (MSL) Support
`
`Territory Business Plans with Specified Target Seqmentation
`
`PTX0438-00051
`
`Call Plan Execution
`
`Message Quality
`
`Selling Skills Assessment and Development
`
`Mmepa
`
`
`51
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`51
`
`MEDA_APTX03501862
`
`
`
`PTX0438-00052
`
`Key Drivers of US Field Force Effectiveness
`Sales Force Alignment and Multi-functional Promotional /Educational_{MSL) Support
`-
`Aligned sales territories with geographical areas having favorable patient access via managed care formulary inclusion
`-
`Increased frequencyof calls to specialists by expanding the AM-R footprint and proportion oftime allocated to promotional efforts
`-
`Increasedutilization of Medical Science Liaisons to improve prescriber understanding ofclinical data
`
`Territory Business Plans with Specified Target Seqmentation
`-
`Targeting of highest potential customers, product loyalists with emphasis on specialists by AM-Rs and FP/Peds by Core
`-
` Well-defined time and resource allocation ,
`including call sample allocations, micro-marketing funds, and access funds
`-
`Reviewed and updated monthlywith the District Manager
`
`Call Plan Execution
`-
`Minimum requirementsforall call activity metrics met byall field representatives (daily call average, % target coverage,etc.)
`
`Message Quality
`-
`Aligned with non-personal and consumer campaigns as directed by the Brand Plan
`-
`Core message supported visually for improved retention
`-
`Retention of Core Messagereflected in ongoing Message Recall Survey data
`
`Selling Skills Assessment and Development
`-
`Practice of Professional Selling Skills (PSS) combined with updated tools and messaging during POA Meetings
`-
`Assessmentof skill application during field observation time by the District Manager via Coaching Trip ASSESSMENES
`@8€2e Updated Personal Development Plans which include targeted areas of skill developmentfor 2015
`
`-
`-
`52
`
`reverenrvemieneniennmtmentnmt
`
`a
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`52
`
`MEDA_APTX03501863
`
`
`
`PTX0438-00053
`
`Sales Force Key Imperatives
`
`Imperative 1: PLAN AHEAD
`
`Imperative
`
`2: EXPAND OUR PRESENCE
`
`Imperative 3: SURROUND THE CUSTOMER
`
`Imperative 4: RAISE THE BAR
`
` Mean
`
`-
`
`-53
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`53
`
`MEDA_APTX03501864
`
`
`
`PTX0438-00054
`
`Sales Force Key Imperatives
`
`Imperative 1: PLAN AHEAD
`We must stay ahead of evolving market dynamics in 2015 by understanding potential changes and developing contingency plans on a macro
`(national) and micro (sales territory) level to address changes in the market(ie. formulary changes, competitive product messaging, etc.). Territory,
`District, and Regional Business Plans will become the common threadfor this planning and adaptation.
`
`Imperative 2: EXPAND OUR PRESENCE
`We must improve brand awareness and product positioning message retention among our called on customers. This will be achieved when every
`representative understands the brand plan for each product, consciously avoids distractions that confuse the message(ie. copay program s), and
`delivers a consistent message with predetermined frequency.
`
`Imperative 3: SURROUND THE CUSTOMER
`We must orchestrate and fully utilize the diverse promotional and educational functions that are designed to meet the various needs of the
`In 2015, we will deploy Respiratory representatives and Account Managers with tactics dedicated to promotional messaging, National
`customer.
`access and pull-through strategies, and Trade Account
`and Regional Account Managers with tactics dedicated to Managed Care farmulary
`we will expand the Medical Science Liaison team to
`andfulfillment strategies. Additionally,
`Managers with tactics dedicated to product availability
`provide clinical support.
`
`Imperative 4: RAISE THE BAR
`From execution of the call plan to advancementsin selling skills, we must demonstrate continuous improvement throughout 2015. Sales goals
`attainment, call plan measures, and personal developmentplan milestoneswill be reviewed on a monthly basis. All field sales colleagues should
`have one defined area of development/improvementin which progress can be demonstrated during each review period.
`Mmepa
`54
`
`
`Dymista
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`54
`
`MEDA_APTX03501865
`
`
`
`Coverage & Reporting
`Target Group Definition,
`*
`are based on the TRx potential for the Branded Nasal
`Targets
`Visit Coverage (8.3.1.2):
`
`Visit
`
`Spray (BNS) market
`
`PTX0438-00055
`
`
`
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`
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`
`Representative-physician
` exisits
`
`-55-
`
`HIGHLY CONFIDENTIAL-
`SUBJECT TO STIPULATED PROTECTIVE ORDER
`
`56
`
`MEDA_APTX03501866
`
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`
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