CREDIT SUISS
`
`‘
`E
`
`11 December 2012
`
`AmericasIUnited States
`Equity Research
`Biotechnology
`
`“"°”°" ““”"“
`Lee Kalolwski
`212 325 9683
`'°°-**"°"5"@°'°°"-S"‘5S°-°°'"
`Catherine 3. Arnold
`
`RM "mm Pm
`212 325 3437
`'3“-"‘°”°“3@°'°°"'5“‘55°-°°'“
`212;2"5-';_;g;
`a,,yam°_jahja@ae,m_5u,Sse_o°m
`Ron“ ,_,_ shah’ ,,,,,m_D_' CFA
`,,,,,,,,,_.,,,,,,,@,,,,_,,’,,‘§,,3—,§f§_’,Z,,’,’,,
`Kw, chino Pm
`212 325 6286
`koon.chilg@credit-suisse.com
`
`Prostate Cancer
`
`_
`_
`_
`Implications of Zytiga's Pre-Chemo Approval
`
`I JNJ’s Zytiga received pre-chemo approval on December 10"‘ (see our
`note “Zytiga pre-chemo approved: still no OS”). There was considerable
`speculation as to whether Zytiga would hit 08 significance with data updated
`since its presentations at ASCO and ESMO this year. We fully expected
`FDA to approve Zytiga for pre-chemo use even without statistically
`significant 08 data, as was indeed the case. Notably, the label does include
`an update to the OS data, but statistical significance was not achieved.
`overall survival looks incrementally worse for Zytiga — which is good
`for Xtandi — though we don’t think it changes how the products will be
`used. The OS difference was only 5.2 months, which is lower than what we
`(and probably most) were expecting. This missed significance with a p-value
`of 0.0151 (Exhibit 1). The placebo arm also saw median OS increase to 30
`months, worsening the HR from 0.75 to 0.79. (Exhibit 2). The data is a little
`puzfling, but between the strong OS trend, the robust rPFS data (HR of 0.43
`on a median treatment duration of 14 months) and the robust OS benefit in
`the “301” trial, we don't think the update changes Zytiga's profile all that
`much or even how it is likely to be used.
`
`I The tolerability profile looks similar to what was seen in the “301” trial.
`As was the case in the "301" trial, Zytiga is associated with liver function
`abnormalities in the pre-chemo setting, underscoring the importance of
`regular LFT monitoring, as has been outlined in the label (Exhibit 3). Cardiac
`failure was also higher with Zytiga (now 2.1% vs 0.7% on placebo). And, of
`course, with the approval in the pre-chemo setting, Zytiga is tied to longer-
`terln use of prednisone (all adverse events from the label are shown in
`Exhibit 4).
`
`I The approval now marks the first meaningful entry into the urology
`segment of the prostate cancer market since DNDN’s Provenge. As per
`JNJ’s Q3 call, about 30% of Zytiga has been in the pre-chemo setting (the
`setting for which Zytiga was just approved), but uptake by urologists has
`been negligible, at least per IMS data. With this approval, we now expect a
`more significant push into the urology segment of the market.
`
`(bullets continue on next page)
`
`ARGENTUM EX1044
`ARGENTUM EX1044
`Page 1
`
`INFORMATION ON
`DISCLOSURE APPENDIX cONTAINs IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS,
`TRADE ALERTS, ANALYST MODEL PORTFOLIOS AND THE STATUS OF NON-U.S ANALYSTS. US Disclosure: Credit
`Suisse does and seeks to do business with companies covered in its research re
`. As a result, investors should be aware
`that the Film may have a conflict of interest that could affect the objectivity of this report. Investors should consider this report
`as only a single factor in making their investment decision.
`
`C|ient—Dn'ven Solutions, Insights, and Access
`
`CREDIT SUISSE SECURITIES RESEARCH & ANALYTICS
`
`BEYOND |NFORMAT|ON®
`
`Page 1
`
`

`
`■ While MDVN (OP, TP: $73) is not disclosing how it might change its
`own statistical plan for its pre-chemo (cid:147)PREVAIL(cid:148) trial, the company is
`confirming that it will wait for OS. This is in-line with our expectations and,
`frankly, makes sense, given that (1) Xtandi has a relatively long patent life
`(2) it offers the potential
`for an OS comparative advantage vs Zytiga,
`especially if that product goes off-patent in around four years and (3) makes
`market entry for downstream competitors all the more challenging. Our best
`guess is that PREVAIL is likely to report out in 2H(cid:146)13 (cid:150) and we expect
`positive results from that trial.
`■ Assuming PREVAIL is positive, National Comprehensive Cancer
`Network (NCCN) guidelines likely will put Xtandi ahead of Zytiga. As we
`noted in our email on December 5th ((cid:147)NCCN Prostate Cancer Guidelines
`Updated: Allows for Xtandi Pre-Chemo Use(cid:148)), Xtandi received in the pre-
`chemo setting a category 2a ((cid:147)lower-level evidence(cid:148)), which is the same as
`Zytiga, despite the (cid:147)302(cid:148) data results (both products are category 1 ((cid:147)high-
`level evidence(cid:148)) in the post-chemo setting). Assuming PREVAIL is positive
`on OS, we would expect Xtandi to move to (cid:147)1(cid:148) (cid:150) the same as Provenge (cid:150)
`while Zytiga is likely to remain where it is.
`■ We are not changing our Xtandi forecasts at this time. Between what we
`see as more favorable tolerability and safety, the lack of required prednisone
`and likely better OS data, we continue to believe that Xtandi will capture a
`larger portion of the post and pre-chemo markets (we model 70% market
`share going to Xtandi vs Zytiga). We continue to believe that PREVAIL will
`show a treatment duration of at least the 14 months seen in the Zytiga (cid:147)302(cid:148)
`trial, resulting in upside from current levels.
`■ For DNDN (N, TP: $4), the Zytiga approval marks the imminent entry of
`a competitor in the pre-chemo (urology) setting. But overall, the timing
`and nature of the approval is in-line with our expectations. Last quarter saw
`a substantial decline at the academic setting (-25%) and we don(cid:146)t think this
`approval and label is likely to change that one way or another. We continue
`to believe that Provenge can be used in a niche setting of the mCRPC
`market (cid:150) i.e. very slowly progressing asymptomatic mCRPC patients (cid:150)
`although it remains to be seen what percentage actually fits into this
`category. Crucial for Provenge(cid:146)s future will be for DNDN to finally gain a
`foothold within the community (and especially community urology) setting
`and JNJ(cid:146)s push here won(cid:146)t make it any easier for DNDN. We are not
`changing estimates at this time (cid:150) we forecast flattish revenues in 2013
`overall vs 2012, with some growth thereafter.
`■ For JNJ (N, TP: $71):
`the Zytiga overall survival data is a slight
`disappointment, however, our (post-2014) Zytiga forecast already implies a
`competitive benefit
`for Xtandi secondary to not requiring prednisone on
`board. The smaller than expected OS benefit now leaves room for Xtandi to
`have a competitive benefit greater than already projected once PREVAIL
`reads out in 2H(cid:146)13. In-line with this, a key element of our Neutral rating on
`JNJ is predicated on the fact that we expect notable competition to emerge
`for several key therapeutic areas in the next 12 months, keeping the stock
`range bound.
`.
`
`Page 2
`
`

`
`\
`CREDIT SUISSE
`
`11 Deoember2012
`
`Exhibit 1: OS Data from Label and as Presented at ASCO 2012
`
`Approved Label
`
`Data Presented at ASCO - June 2012
`
`
`
`Overall Survival
`
`Zytiga (N: 546)
`
`Median Suvival
`
`pvalue
`Hazard Ratio
`
`Placebo (N=542) Overall Survival
`Deaths
`
`30.1 Median Suvival
`
`p—va|ue
`Hazard Ratio
`
`Zytiga (N: 546) Placebo (N=542)
`
`27.
`
`Source: Company data, Credit Suisse estimates
`
`Exhibit 2: cs curves — From Label U dated Data and at ASCO
`0
`3
`6
`9
`12
`15
`
`Zytiga-updated
`Placebo-updated
`
`Zytiga-ASCO
`Placebo-ASCO
`
`546
`542
`
`546
`542
`
`538
`534
`
`538
`534
`
`524
`508
`
`524
`509
`
`503
`492
`
`503
`493
`
`482
`465
`
`482
`465
`
`452
`437
`
`452
`437
`
`
`
`18
`
`421
`400
`
`412
`387
`
`2 1
`
`393
`361
`
`258
`237
`
`24
`
`333
`283
`
`120
`106
`
`2 7
`
`175
`153
`
`27
`25
`
`Source: Company data, Credit Suisse estimates
`
`Exhibit 3: Liver Function Abnonnalities From Label
`
`High ALT
`
`High AST
`Total
`
`"301"
`
`"302"
`
`A||Grades
`
`Grade 3-4 A||Grades Grade 3-4
`
`30.6
`
`11.1
`41.7
`
`2.1
`
`1.4
`3.5
`
`41.9
`
`37.3
`79.2
`
`6.1
`
`3.1
`9.2
`
`Source: Company data, Credit Suisse estimates
`
`Exhibit 4: Z i a AEs from A o roved Label
`
`Zytiga —"301“
`All Grades
`Grade 3-4
`
`Zytiga —"302"
`All Grades
`Grade 3-4
`
`Joint Swelling/discomfort
`Muscle Discomfort
`
`Edema
`Hot flush
`Hypertension
`Diarrhea
`Dyspepsia
`Urinary tract infection
`Upper respiratory tract
`Cough
`Urinary frequency
`Nocturia
`Fractures
`
`Arrhythmia
`Chest pain or chest discomfort
`Cardiac failure
`
`.
`.
`.
`
`.
`.
`.
`
`Source: Company data, Credit Suisse estimates
`
`.
`.
`
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`.
`
`.
`.
`.
`
`Fatigue
`Edema
`
`Pyrexia
`Joint swelling/discomfort
`Groin pain
`Constipation
`Diarrhea
`Dyspepsia
`Hot flush
`Hypertension
`Cough
`Dyspnea
`Insomnia
`
`Contusion
`Falls
`Upper respiratory tract
`Nasopha ryngitis
`Hematuria
`Rash
`
`Prostate cancer
`
`Page 3
`
`Page 3
`
`

`
`‘
`CREDIT SUISSE
`
`Companies Mentioned (Price as of 10-Dec-2012)
`Dendreon corp. (DNDN.OQ. $5.04, NEUTRAl_[V|, TP 540)
`Johnson a Johnson (JNJ.N, $70.6, NEUTRAL, TP $71.0)
`Medivation (MDVN.OQ_ $55.33, 0UTPERFORM[V]_ TP $73.0)
`
`11 December 2012
`
`Disclosure Appendix
`
`Important Global Disclosures
`
`Lee Kalowski, Cathenne J. Arnold, Ravi Mehrotra PhD, each certify, with respect to the companies or securities that the individual analyzes, that (1)
`the views expressed in this report accurately retlect his or her personal views about all of the subject companies and securities and (2) no part of his
`or her compensation was, is or will be directly or indirectly related to the specitic recommendations or views expressed in this report.
`
`Price and Rating History for Dendreon Corp. (DNDN.OQ)
`
`DNDN-00
`Date
`02-May-11
`03Aug—11
`09-Sep-11
`03-Nov-11
`30Jan-12
`27-Feb-12
`
`08-May-12
`31-Jd-12
`o5_Nov_12
`
`Closing Price
`(uss)
`42.81
`35.84
`11.42
`6.55
`14.17
`11.81
`
`8.75
`4.76
`4_17
`
`Taruel Price
`(uss)
`29.00
`22.00
`14.00
`11.(X)
`14.00
`13.00
`
`12.00
`6.(X)
`41”
`
`— Target Price — Closing Price DNDN.0Q
`
`Rating
`U '
`N
`
`43
`
`33
`
`23
`
`13
`
`.
`3
`1-May-11
`
`.
`1-$p-11
`
`.
`1-.hn—12
`
`.
`1-May—12
`
`.
`1-$p-12
`
`' Asterisk signifies initiation or assumption of coverage.
`
`IHIYIIAL
`IIIIDEIWERFOIII
`
`Price and Rating History for Johnson & Johnson (JNJ.N)
`
`Closing Price
`
`Taltlei Plice
`
`— Target Price — Closing Price .N.1N
`
`JNJ-N
`
`19-Jan-10
`
`21-Apr-10
`04-Jm-10
`21-JIl—10
`27-Aug-10
`26-Jan-11
`
`18-Apr-11
`113ep—12
`
`65.35
`
`65.39
`58.01
`57.12
`57.60
`60.60
`
`60.46
`6820
`
`71.1”
`
`73.00
`09.“)
`66.“)
`65.!”
`63.1”
`
`70.00
`
`N
`
`R
`N
`
`' Asterisk signifies initiation or assumption of coverage.
`
`Price and Rating History for Medivation (MDVN.OQ)
`
`70
`
`65
`
`60
`
`55 .
`1—.hn-10
`IIEIITIIAL
`namucrzn
`
`.
`1-.hn-11
`
`.
`1-Jan-12
`
`— Target Price — Closing Price MDVN.OQ
`
`MDVN-00
`Date
`301lan-12
`24-Feb-12
`29-Fel»12
`13-Mar-12
`
`14-Mar-12
`23-May-12
`044m-12
`
`10-Aug-12
`
`Cicsins Price
`(uss)
`27.44
`3250
`3276
`35.70
`
`Tame! Price
`(uss)
`76.00
`9200
`90.00
`
`352::
`-14.17
`40.82
`
`48.85
`
`90.00
`115.00
`12200
`
`120.00
`
`73.00
`45.70
`11-Nov-12
`' Asterisk signifies initiation or assumption of coverage.
`
`Rating
`0 '
`
`R
`
`0
`
`80
`
`50
`
`40
`
`20
`
`.
`.
`.
`.
`.
`1-MHF 12
`1—May—12
`1-Jll—12
`1-W-12
`1-NOV-12
`.,..,..E...,.,...- R31’IIIGTED
`
`Prostate cancer
`
`Page 4
`
`Page 4
`
`

`
`\
`CREDIT SUISSE
`
`11 December 2012
`
`The analyst(s) responsible for preparing this research report received Compensation that is based upon various factors including Credit Suisse's
`total revenues, a portion of which are generated by Credit Suisse's investment banking activities
`
`As of December 10, 2012 Analysts’ stock rating are defined as follows:
`
`Outperfonn (0) : The stock’s total return is expected to outperform the relevant benchmark'over the next 12 months.
`
`Neutral (N) : The stock's total retum is expected to be in line with the relevant benchmark‘ over the next 12 months.
`
`Underperfonn (U) : The stock's total retum is expected to underperfonn the relevant benchmark‘ over the next 12 months.
`‘Relevant benchmark by region: As of 10th December 2012, Japanese ratings are based on a stock's total retrrm relative to the analyst's coverage universe which
`consists of all companies covered by the analyst within the relevant sector, with Outperfonns representing the most attractive, Neutrals the less attractive, and
`Underperfonns the least attractive investment opportunities. As of 2nd October 2012, U. S. and Canadian as well as European ratings are based on a stock's total
`return relative to the analysts coverage universe which consists of all companies covered by the analyst within the relevant sector, with Outperfonns representing the
`most attractive, Neutrals the less attractive, and Underperfonns the least attractive investment opportunities. For Latin American and nonalapan Asia stocks, ratings
`are based on a stock's total return relative to the average total return of the relevant country or regional benchmark; Australia, New Zealand are, and prior to 2nd
`October 2012 U. S. and Canadian ratings were based on (1) a stock's absolute total return potential to its current share price and (2) the relative attractiveness of a
`stock's total return potential within an analyst's coverage universe. ForAustralian and New Zealand stocks, 12-month rolling yield is incorporated in the absolute total
`return calculation and a 15% and a 7.5% threshold replace the 10-15% level in the Outperform and Underperform stock rating definitions, respectively. The 15% and
`7.5% thresholds replace the +10-15% and —10—15% levels in the Neutral stock rating definition, respectively. Prior to 10th December 2012, Japanese ratings were
`based on a stock's total retum relative to the average total return of the relevant country or regional benchmark.
`
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`circumstances.
`
`Volatility Indicator[V] 2 Astockis defined asvolatile iftlre stock price has moved up ordown by20%ormore in a month in at least8 ofthe past 24
`months or the analyst expects significant volatility going forward.
`
`Analysts’ sector weightings are distinct from analysts’ stock ratings and are based on the analyst's expectations for the fundamentals andlor
`valuation of the sector‘ relative to the group's historic fundamentals andlor valuation:
`
`Overweight : The analyst's expectation for the sector's fundamentals andlor valuation is favorable over the next 12 months.
`
`Market Weight : The analyst's expectation for the sector's fundamentals andlor valuation is neutral over the next 12 months.
`
`Underweight : The analyst's expectation for the sectors fundamentals andlor valuation is utious over the next 12 months.
`‘An analyst's coverage sector consists of all companies covered by the analyst within the relevant sector. An analyst may cover multiple sectors.
`
`Credit Suisse's distribution of stock ratings (and banking clients) is:
`
`Global Ratings Distribution
`
`Versus universe (%)
`Rating
`42%
`0ufperfnrrnlBuy'
`39%
`Net.lIl'a|IHtM'
`15%
`U
`3%
`Restrided
`‘For purposes of the NYSE and NASD ratings distribution disclosure requirements, our stock ratings of Outpeifonn, Neutral, and Underperfonn most closely
`correspond to Buy, Hold, and Sell, respectively,‘ however, the meanings are not the same, as our stock ratings are determined on a relative basis. (Please refer to
`definitions above.) An investor's decision to buy or sell a security should be based on investment objectives, current holdings, and other individual factors.
`
`Of which banking clients (%)
`(54% banking clients)
`(4896 banking clients)
`(4495 banking clients)
`
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`ana|yticsIdisdainierlnianaging_corrflicts_disclainier.htrrl
`
`Credit Suisse does not provide any tax advice. Any statement herein regarding any US federal tax is not intended or written to be used, and nnot
`be used, by any taxpayer for the purposes of avoiding any penalties.
`
`Price Target: (12 months) for Dendreon Corp. (DNDN.OQ)
`
`Method: Our $4 target price for DNDN is derived from a discounted cash flow modeled to 2020 using a terminal growth rate of 5% and a dscount
`rate of 10%.
`
`Risk:
`
`Upside risk to our $4 target price include an accelerating launch trajectory, geater reaized cost cutting than we model and successful
`commercialization in the EU; downside risk include: a launch trajectory below our expectations, greater competition than we anticipate and
`a higier cost base than we cunently model.
`
`Prostate cancer
`
`Page 5
`
`Page 5
`
`

`
`11 December 2012
`
`CREDIT SUISSE
`
`Price Target: (12 months) for Johnson & Johnson (JNJ.N)
`
`Method: Our $71 target price for JNJ is based on a Sumof-the-Parts analysis, using peer averages in related consumer, devices and phanna
`businesses to assign value to each of JNJ's business units. The combined peer group consists of about 20+ companies. and the analysis
`results in applition of a blended multiple of 12.9x JNJ's 2013 earnings.
`
`Risk:
`
`Key upward risks to our $71 target price include nrore aggressive dealmaking or capital deployment by the company, and deterioration of
`macro environment leading to a flight to safety. Downward risks to our target price include conservative use of cash, and an improvement
`in the the macro environment leading to greater appetite for risk.
`
`Price Target: (12 months) for Medivation (MDVN.0Q)
`
`Method: Our Price Target of $73 is derived from a discounted cash flow modeled to 2020 followed by a terminal growth up to patent expiry and no
`further cash tlows.
`
`Risk:
`
`Risks to our $73 target price include delay in or lack of approval in either the post or prechemo indtion or lower penetration than we
`assume.
`
`Please refer to the tinn's disclosure website at www.credit—suisse.conrIresearchdisclosures for the definitions of abbreviations typilly used in the
`target price method and risk sections.
`
`See the Companies Mentioned section forhrl company names
`
`The subject company (DNDN.OQ, JNJ.N, MDVN.0Q) currently is, or was during the 12-month period preceding the date of distribution of this report,
`a client of Credit Suisse.
`
`Credit Suisse provided investment banking services to the subject company (JNJ.N, MDVN.0Q) within the past 12 months.
`
`Credit Suisse has managed or ccmanaged a public offering of securities for the subject company (MDVN.0Q) within the past 12 months.
`
`Credit Suisse has received investment banking related compensation from the subject company (JNJ.N, MDVN.0Q) within the past 12 months
`
`Credit Suisse expects to receive or intends to seek investment banking related compensation from the subject company (DNDN.0Q, JNJ.N,
`MDVN.OQ) within the next 3 months.
`
`As of the date of this report, Credit Suisse makes a market in the following subject companies (DNDN.0Q, JNJ.N, MDVN.0Q).
`
`Credit Suisse has a material conflict of interest with the subject company (MDVN.0Q). A Credit Suisse analyst involved in the preparation of this
`report has a long position in the common stock of MDVN
`
`Important Regional Disclosures
`
`Singapore recipients should contad Credit Suisse AG, Singapore Branch for any matters arising from this research report.
`
`The analyst(s) involved in the preparation of this report have not visited the material operations of the subject company (DNDN.0Q, JNJ.N,
`MDVN.0Q) within the past 12 months
`
`Restrictions on certain Canadian securities are indited by the following abbreviations: NVS—Non—Voting shares; RVS—Restricted Voting Shares;
`SVS-Subordinate Voting Shares.
`
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`
`Prostate cancer
`
`Page 6
`
`Page 6
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`

`
`11 December 2012
`
`CREDIT SUISSE
`
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