`Mylan Laboratories Limited v. Aventis Pharma S.A. IPR2016-00712
`
`
`
`Medical Technology
`
`Company Description:
`
`WELLS FARGO SECURITIES, LLC
`EQUITY RESEARCH DEPARTMENT
`
`New Brunswick-based Johnson & Johnson, through its more than 250 operating companies, is the world's
`most comprehensive and broadly based manufacturer of health care products, as well as a provider of related
`services, for the consumer. phannaceutical, and medical devices and diagnostics markets. The medical devices
`and diagnostics segment consists of a range of products including Cardiovascular Care, DePuy Synthes
`orthopedics, surgical and infection prevention products, LifeScan blood glucose monitoring and insulin
`delivery products, Ortho-Clinieal Diagnostics products, and Vistakon disposable contact lenses. The company
`reported 2013 sales of $71.33, up 8% year-over-year.
`
`Continued from the previous page.
`
`Urologist data showed Zytiga with 25% share of the market. Urologists are key prescribch in the
`pro-chemo segment of the market. On a rolling 3—month basis through May, Zytiga held 25% market share vs.
`3-month average of 27% in May 2013 (12-month range of 22-35%) (Figure 6). Over the same time period,
`Xtandi share has increased from 2% to 14%. However, hormone therapy (ADT or androgen deprivation
`therapy) remains the market leader among the sample urologists with Lupron Depot holding 58% rolling
`3—month share (vs. 65% average share a year ago). Casodex’s rolling 3-month share also declined from 23% a
`year ago to 17% share most recently. The key caveat we highlight here is the small sample size of 45-50
`urologists each month compared to about 150 oncologists in the survey. As such, Symphony provides the
`urologist share data on a rolling 3-months basis while the oncologist data is shown monthly.
`
`IMS prescription (Rx) data shows continued Zytiga uptake albeit at slower rate. Weekly Rx data
`showed continued uptick in Zytiga uptake in the U.S. in terms of Rx volume (Figure 7-3). For the 4~ week
`period ended 6f13f14, Zytiga 'I'Rx totaled 9,233, up 1596 yrfyr, while 4-week NR3 totaled 2.793, up 4% yrfyr.
`While [MS data does not break Out pre- vs. post-chemo usage, we note that urologists now account for 8«9% of
`Zytiga NRx, up from 2% a year ago. As we discussed above, continued uptick in urologist Rx. Shauld help Zytiga
`to further penetrate the pre-chemo segment.
`
`Expect JNJ’s prostate cancer franchise to continue to grow in 2014 - Qt market growth
`appeared robust. Zytiga has been one of JNJ’s best new drug launches with global sales totaling $1.73 in its
`third year on the market. Q1 U.S. Zytiga sales were $229M (+42% yr/yr) while OUS sales totaled $283MM
`(+55% ex-FX yr/yr) (Figure 9). According to JNJ. the US. prostate cancer market grew 10% in Q1, a
`deceleration from +18% in Q4 and +25% in ()3 2013, and Zytiga continued to gain share. OUS growth was
`driven by continued label expansion in new countries and progress on reimbursement. We expect that overall
`market expansion, further pro-chemo penetration and additional country roll-outs will drive 2014 Zytiga
`growth of +32% to $2.23 WW and +30% to $976MM in the US. Competitor MDVN/Astellas' Xtandi is
`expected to be approved for pro-chemo use by mid-Sept (9/18/14 PDUFA date), if not sooner, in the U5. and
`in 2015 in the EU.
`
`Aggregating reported sales for several new prostate cancer agents, we estimate Q1 global sales totaled
`$393MM or 61% yrjyr growth (Figure 9). [n the 11.5., sales rose 51% to nearly $500MM while OUS sales
`increased 7595 to nearly $4ooMM. While we anticipate solid global growth to continue, we expect OUS growth
`to continue to outpace U.S. growth in the coming quarters. Note that this market model includes primarily
`newer agents approved for CRPC and thus excludes hormone therapy such as Lupron Depot, chemo agent like
`Taxotcre and supportive care products like Zometa and prcdnisone.
`
`New Zytiga patent may be coming soon. On June 2, the US Patent & Trademark Office (PTO) allowed
`JNJ’s Zytiga patent application 13/034340, suggesting that the patent could officially issue in the coming
`weeks or months. Once issued. we expect JNJ to list the method of use patent in the FDA Orange Book, which
`would force generic filers to go through the patent challenge in court and at a minimum delay generic
`competition beyond current Dee. 2016 composition of matter patent expiration and provide a bridge to
`ARM-509 which is in Phase 3 development. If the new patent is listed and upheld in a patent challenge, Zytiga
`would be protected until 2026. While there is increasing competition in the prostate cancer therapy market, we
`expect Zytiga sales to continue to grow in the near- to medium—term and to remain a solid profit contributor
`longer-term even on flat to declining U.S. sales. Although the patent allowance is not new (same application
`was previously allowed in July 2013), the new allowance suggests that the process is moving ahead as JNJ
`works to strengthen the patent claims. As such, while the exact timing of the patent issuance is unclear, our
`patent consultant felt confident that the patent will ultimately issue (well ahead of the 2016 COM patent
`expiration) and that the patent will provide strong protection for Zytiga against generic competition. See our
`JNJ note “Nae Zyflga Patent With 2026 Expiration Could [me Soon” dated 6/11/14for additional details.
`
`
`
`CabRef0012619
`
`
`
`WELLS FARGO SECURITIES, LLC
`Johnson 8: Johnson EQUITY RESEARCH DEPARTMENT
`
`
`
`Caveats about Symphony survey: 1) small physician sample size; 2) postwehemo represents 5096+ of the
`survey market even though there are 2-3x as many [Ire-chemo patients-4ide due to concentration of
`oncologists in the survey, who prescribe more for post-chemo: 3) inclusion of supportive care products likely
`nnderstates brand share; 4) overall share trend may show small discrepancy (+l- 1%) to the pre- and
`post~chemo share trends due to inclusion of “unknown” chemo status patients in the overall population.
`
`+All0lha I Jewana +lupronDcpm A Prawns: *lmokere we mandi +Zytiga
`JI-‘ie —O-Ail01:har - 0 12mm + Luprun Depot
`
`3 i E E E E3 §a
`
`n
`
`Fi
`
`Eaz Eg
`
`r:i34
`“Vi-33‘
`
`-
`
`f.
`'-‘
`
`.:=,,
`'1'
`
`'
`
`:.
`
`=V
`'2-
`
`-.-,f.
`
`_:'.
`'-.
`
`--'
`
`n:
`~
`'::
`
`"I;
`2:
`
`~
`
`“‘47,
`2"“
`
`“1;:
`:rn‘e4.
`
`
`
`30
`
`Nc
`
`H6
`
`a E33
`
`9
`
`.;1
`-'.-
`JI-"i
`
`.
`-’...r.
`am":
`
`_-r
`"-1..
`am?
`
`-
`--
`
`.
`
`..
`
`.
`
`.
`‘
`
`.
`:-=
`
`g
`.
`1'
`
`I.
`.-
`’_
`
`r
`
`_ \n
`-.
`c
`:3
`
`Apr
`.
`x:-
`h.
`::«!'5
`
`“.wa-
`-a
`
`-— Fmvmge —+—Tamtere +~Xumi —-I— Zyt‘ea «H xafigc ~0- Camden:
`
`Source: Symphony Health Solutions
`Note: In Q1 2013, Xiandi received NCC‘N (National Comprehensive Cancer Network) compendium listing for
`pro—chemo setting, which faciiitam; reimbursement for off-label use in pre-chemo.
`
`
`
`CabRef0012620
`
`
`
`WELLS FARGO SECURITIES, LLC
`Medical Technology EQUITY RESEARCH DEPARTMENT
`
`
`
`
`
`
`
`fpcm-Ehem:
`
`96“line‘I‘IeatulNtienls
`
`wa
`
`Sep
`“fléi
`31-2:
`
`Oct
`H~13:
`arer
`
`Nov
`5-5;
`3-33
`
`Dec
`1-1;}
`‘31-?
`
`w -;‘
`z:
`=1
`
`-:_
`Z.
`
`-
`
`‘
`n_1:3
`c:-'£
`
`Apr
`«~53
`3M:
`
`Mn
`«-u:
`:r-v':
`
`~ Plovmge +Taxotse DO“ Randi —I—vaga " 0"“ Xufagn "r" Cased“
`
`*Pra—Chemfl
`
`* Altho‘ugh note promoted in [are-chemo setting, Xtandi received NCC'N {National Comprehensive Cancer
`Network) compendium listing for pie-chemo setting in Q1 2014, which facilitated reimbursement fnr off-label
`use.
`
`
`
`CabRef0012621
`
`
`
`\VELIS FARGO SECURITIES, LLC
`Johnson 8: Johnson EQUITY RESEARCH DEPARTMENT
`
`
`
`Figure 5. CRPC Line of'l‘herapy By Brand Among Sample 9mm
`
`REM Ma 20 I
`
`
`
`
`
`94'-lhiqln‘lmtedPaint
`
`{and
`n=552
`
`2':ng
`"=66:
`
`Proverlge
`n=55
`
`Jemana Tandem
`nab“
`rue-223
`
`x. 1:! DH. :lelepr “mum Fromm “Mr
`Ilrh Lqu 2mm 0' macaw-mm tau-w
`
`Kohgo
`n=33
`
`Camden
`m7:
`
`{upron
`Jena.
`n=£2;
`I :re Jinn-Its? iuanl'1F'?z1ltl :IHW
`
`124114 January 2013
`
`.a
`'l
`
`5E'
`
`- i{
`
`- §5a
`
`I ha _ w: :3: :a‘:- haunt :13“:
`
`'
`
`
`!
`
`I .31 ..--s Cum“.- in art =13“ :nnn-
`
`titanium;
`
`
`
`flailfinnullMints
`
`May
`r-* 11-".
`«:52
`
`Jun
`n=55
`am?
`I Jenna + Luann Depot
`- A Prawns! —a~—1’amm + lanai +M‘p
`
`Source: Symphony Health Solutions
`
`
`
`CabRef0012622
`
`
`
`
`
`WELLS FARGO SECURITIES, LLC
`Medical Technology EQUITY RESEARCH DEPARTMENT
`re .Weekl
`'I‘RxandNRxU kc.on '
`
`r
`3,000
`!
`r
`
`+ TR):
`
`‘ “Rx
`
`.
`
`u.
`
`~
`
`*
`
`1
`
`'
`
`'3
`U
`‘
`l .-
`
`i
`i
`
`2. 500
`
`E 2.000
`E
`"3 1,500
`lg
`E 1,000
`
`500
`
`_
`
`a
`
`D :
`
`7126113
`2115113
`917112
`3130112
`10121111
`5113111
`SéfififismafiifiénalFTesdfififiEiTAfi—Emmfiiég
`
`113114
`
`6113114
`7
`
`8- Four-WMEQ ingfiggpfzmflcmm___w__mw_ A__
`100% i
`7
`
`:
`
`4mYIYRxgrowth 3ga?a?
`
`N§
`
`
`
`0%
`5125112
`
`
`3119113
`8115113
`1111114
`619114 _
`4-week ended
`seam [Ms HealtBfliiiém-poraiéd,‘ National PresE‘ripT'idn AuditSWel'is Ffi'E‘eEEr—ifiéé; 'LLC'
`
`10121112
`
`Any analysis is independently arrived at by Wells Fargo Securities. LLC, on the basis of the data and other
`information, and IMS is not responsible for any reliance by recipients on either the data or any analyses
`thereof.
`
`6
`
`CabRef0012623
`
`
`
`Johnson 8: Johnson
`
`WELLS FARGO SECURITIES, LLC
`EQUITY RESEARCH DEPARTMENT
`
`- re 'lMarketforNe
`"
`.
`‘
`.'
`‘
`U.‘
`
`,..
`{an
`I
`,_
`.
`7‘77
`:
`f
`..‘
`i
`_
`_
`-_
`_:
`,:-;:~",L_:-:~-
`
`Pre-Chomo [Dec-12). Post-Chemo (Apr-11)
`Fri- nnd Post-Chemo
`
`Pom-Chemo (Aug-12); Pm-Cmmo (Sop-HE)
`PostChsmn {Jun-13); Flt-Chemo (Dancing)
`
`-
`
`Pro-Chemo {Apr-10)
`Pro-Charm ($6913) - launch 4014a
`
`-
`
`PmlChel-no (Jun-1D)
`Pom-Chemo (Mar-10)
`
`PIE and PostChm-no {May-13)
`PIE and Postmnmo (News;
`
`
`
`r
`
`-
`
`-
`
`-
`
`-
`
`-
`
`-
`
`$12
`5229
`5283
`
`S172
`5125
`$48
`
`$69
`$69
`-
`
`$90
`527
`$63
`
`$49
`549
`-
`
`5393
`5499
`5394
`
`6158
`51%
`
` ‘ Ills Fame Securities. LLC
`
`(a) Hand 1013 sales include $4.4M Mannie gross-tuna adiustmam retaking to prior quarters. nandi 3cm sales include $7M of distnmnnr inn-Mary Increase
`(5} Promo: sales In 4012 mind. 53 BM launratlo Imminent tn cuch resume. Pro karma sills mm W
`
`CabRef0012624
`
`
`
`Medical Technology
`
`EQUITYRESEARCHDEPARTMENT
`WEIJS FARGO SECURITIES, LLC
`
`Johnson 5 Johnson (JNJ) 3-yr.Price Pefiormance
`
`.
`
`|
`
`!
`
`l
`
`,
`
`l
`
`‘
`-
`
`.
`~
`
`‘
`
`‘11‘m
`1
`amen :
`5mm
`
`u v — — . — .-..
`
` Sun-m: Wale Fame SIumHInJLC ruin-Ins and Ramon flat:
`Erhan I"
`v
`Raina [la-manna
`I
`Rating Upgrade
`I
`Vllualinn Rll'lfll Change
`
`0 Man. Real-mph», Drug orSulpenu
`I
`Ann"!Change
`"i
`Spflflpunllllm
`
`Ruin. Colo KO!
`1
`Otflpeflumlfluy
`5R
`2 Malkal Pllhrrnamid
`NR
`3
`Undelpurfnrmeefl
`RE
`Additional Information Available Upon Request
`
`Suspend-d
`Nut Ralnd
`NuEuhmam
`
`issuers discussed; and
`
`2] No part ofmy compensation was, is, or will be, directly or indirectly. related to the speci
`by me in this research report.
`
`CabRef0012625
`
`,:
`
`II
`
`I
`
`
`
`
`
`STOCK RATING
`
`next 12 months. BUY
`
`EQUITY RESEARCH DEPARTMENT
`Johnson &Johnson
`WELLS FARGO SECURITIES, LLC
`=0utpcrfonn:Thestockappears attractivelyvalued,and Webelievethestock's totalreturn will exceedthatofthemarketOverthe
`Randal-kc: Perform: The stock appears appropriatelyvalued, and we believe the stock'5 total return will be in line with the market
`3=Underperfonn: The stock appears overvalued, and we believe the stock's total return will be below the market overthe next 12
`
`over the next 12 months. HOLD
`
`months. SELL
`
`SECTOR RATING
`
`O=0verwcight: Industry expected to outperform therelevant broad market benchmarkoverthenext 12 months.
`M=Market Weight: Industryexpected to perform in-linewith the relevant broad market benchmarkoverthe next 12 months.
`U=Underweight: Industry expected to under-performthe relevant broad market benchmarkOverthe next 12 months.
`V = A stock is defined as volatile ifthe stoek price has fluctuated by +/—2o% or greater in at least 3 ofthe past 24 months or ifthe
`
`VOIATILITY RATING
`
`As of: June 26, 2014
`
`4996 of companies covered by Wells Fargo Securities, LLC Wells Fargo Securities. LLC has provided investment banking
`Equity Research are rated Outperform.
`services
`for 45% of
`its Equity Research Outperform-rated
`48% ofcompanies covered by Wells Fargo Securities, LDC Wells Fargo Securities, LLC has provided investment banking
`Equity Researcharcrated Market Perform.
`services for 35% of its Equity Rwearch Market Pcrfonn-rated
`396 of companies covered by Wells Fargo Securities. LLC Wells Fargo Securities, LLC has provided investment banking
`Equity Research are rated Underperform.
`services
`for 7% of its Equity Research Underperfornrrated
`
`compaiucs.
`
`companies.
`
`companies.
`
`and should not be relied upon by, retail clients.
`
`clients will therefore not app] , nor will the Financial Services Compensation Scheme be available. This report is not intended for.
`Australia —‘Wells Fargo Securities, LLCis exempt from the requirementsto hold an Australian financial services license in respect
`
`HongKong - This report is issued and distributed in Hong Kong byWells Fargo SecuritiesAsiaLimited ("WFSAL"), a Hong Kong
`incorporated investment firm licensed and regulated by the Securities and Futures Commission to carry on types 1. 4. 6 and 9
`regulated activities (as defined in the Securities and Futures Ordinance, ‘thc SFO”). This report is not intended for. and should not
`be relied on by, any person other than profeSsional
`investors (as defined in the SFO). Any securities and related financial
`instruments described herein are not intendedforsale, norwill be sold, toany person otherthan professional investors (as defined
`
`CabRef0012626
`
`
`
`WELLS FARGO SECURITIES, LLC
`EQUITYRESEARCH DEPARTNIENT
`
`Medical Technology
`About Wells Fargo Securities, LLC
`Wells Fargo Securities is the trade name for the capital markets and investment banking services ofWells Fargo 8: Company and its
`subsidiaries, including but not limited to Wells Fargo Securities, L
`, at us. broker-dealer registered with the US. Securities and
`Exchange Commission and a member of NYSE, [-‘INRA, NFA and SIPC. WelLs Fargo Institutional Securities. LLC, a member of
`FINRA and SIPC, Wells Fargo Prime Services, LLC, a member of FINRA, NFA and SIPC, Wells Fargo Bank, NA. and Wells Fargo
`Securities International Limited, authorized and regulated by the Financial ConductAuthority.
`Wells Fargo Securities, LIE is a US. brokerdealcr registered with the {1.8. Securities and Exchange Commission and a member of
`theNewYorkStock Exchange, the Financial Industry RegulatoryAuthorityandthe Securities Investor Protection Corp.
`This report is for your infomation only and is not an offer to sell, or a solicitation ofan offer to buy, the securities or instruments
`named or described in this report. Interested parties are advised to contact the entity with which they deal, or the entity that
`provided this report to them. if they desire further information. The information in this report has been obtained or derived from
`sources believed by Wells Fargo Securities, LLC, to be reliable. but Wells Fargo Securities, LLC, does not represent that this
`information is accurate or complete. Any opinions or estimates contained in this report represent
`the judgment of
`Wells Fargo Securities, LLC. at this time, and are subject to change without notice. For the purposes ofthe UK. Financial Conduct
`Authority‘s
`rules,
`this
`report constitutes
`impartial
`investment
`research. Each of Wells Fargo Securities
`L
`
`SECURITIES: NOT mleSURED/NOT BANKflUARANTEED/MAY [DEE VALUE
`
`M
`
`CabRef001 262 7
`
`