Global Biotechnology
Transcript of Global Biotechnology
DISCLOSURE APPENDIX AT THE BACK OF THIS REPORT CONTAINS IMPORTANT DISCLOSURES, ANALYST CERTIFICATIONS, AND THE STATUS OF NON-US ANALYSTS. US Disclosure: Credit Suisse does and seeks to do business with companies covered in its research reports. As a result, investors should be aware that the Firm 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.
CREDIT SUISSE SECURITIES RESEARCH & ANALYTICS BEYOND INFORMATION®
Client-Driven Solutions, Insights, and Access
18 July 2014
Americas/United States
Equity Research
Biotechnology (Biotechnology (US)/Biotechnology & Biopharmaceuticals
(Europe)) / MARKET WEIGHT
Global Biotechnology CATALYST ALERT
Q2 Earnings Preview: Pipelines And Domain
Domination An Increasing Focus
Quick reference Q2 preview summaries for our coverage universe included in this document: The CS biotech team covers 50 companies or 86% of the sector’s market-cap (of the Top 100 companies Exhibit 2-Exhibit 3); we provide an earnings calendar for the Top US/EU Biotech and Pharma companies (Exhibit 17-Exhibit 18). Themes going into Q2 reporting season: Large Cap growth still central to sector performance but focus on “Domain Domination” and concomitant post 2020 pipeline impact increasing. The biotech sector has seen notable volatility YTD – starting the year by continuing in its #1 (for 4
th year in a row)
spot vs. other major sectors, but falling to the worst performing sector in March as the drug pricing debate impacted performance. The rally in the sector since March has principally been driven by the market exploiting the “market inconsistencies” toward growth and using large cap biotech as the principal tool (in line with our thesis detailed in 4
th June sector review - LINK) to bring the
sector back to the #4 position (Exhibit 5-Exhibit 6). As such we still view our long standing “generalist GARPy Inflows” hypothesis as intact (LINK). It is notable that FY14 top/bottom-line growth for PE; Biotech 38%/76% for 20x vs. S&P500 3%/8% for 17x (Exhibit 11) and long term growth/valuation matrices are just as compelling (Exhibit 10). Notwithstanding the above argument for continued performance based on near/medium term growth, we note that much of conversations with investors recently has been focused on longer term growth prospects for LC biotech: BIIB – anti-lingo, GILD – “what's next?” (after HCV), CELG – GED0301/MOR202 (ok self-serving! – LINK) and AMGN – PCSK9/Sclerostin. Linked to this, our conversations around “Domain Dominance” in the sector (LINK, LINK) continue to increase. Key picks in sector: Large Cap: CELG and BIIB; SMID: PTCT, CLVS, MDVN.
Exhibit 1: 2014 YTD Biotech (dark blue) vs. major sectors
Source: Company data, Credit Suisse estimates – see Exhibit 5 for granularity
Research Analysts
Ravi Mehrotra PhD
212 325 3487
Jason Kantor, PhD
415 249 7942
Lee Kalowski
212 325 9683
Koon Ching PhD
212 325 6286
Jeremiah Shepard, PhD
415 249 7933
Anuj Shah
212 325 6931
18 July 2014
Global Biotechnology 2
Price Price Rating* Target Price Year EPS EPS FY1E EPS FY2E EPS FY3E
Company ccy 17 Jul 14 Prev. Cur. Prev. Cur. End Ccy Prev. Cur. Prev. Cur. Prev. Cur.
Amgen Inc. (AMGN) US$ 115.39 — N — 125.00 Dec 13 US$ — 8.17 8.39 8.47 8.60 8.68
Biogen Idec (BIIB) US$ 299.29 — O — 400.00 Dec 13 US$ — 11.42 14.06 13.91 16.50 16.36
Celgene Corp. (CELG) US$ 83.13 — O — 112.50 Dec 13 US$ — 3.59 4.85 4.77 6.37 6.29
Corcept Therapeutics (CORT) US$ 2.33 — N — 2.00 Dec 13 US$ — (0.46) — (0.09) 0.24 0.25
Enanta Pharmaceuticals (ENTA)
US$ 37.88 — O — 43.00 Sep 13 US$ — 0.84 5.85 5.87 2.87 2.88
InterMune (ITMN) US$ 40.59 — N — 33.00 Dec 13 US$ — (2.34) — (1.56) — 0.36
Ironwood Pharmaceuticals (IRWD)
US$ 13.33 — O — 16.00 Dec 13 US$ — (1.03) — (0.20) — 1.02
Receptos (RCPT) US$ 34.49 — O — 58.00 Dec 13 US$ — (3.76) — (0.06) — (6.40)
Sucampo Pharmaceuticals (SCMP)
US$ 6.11 — N — 8.00 Dec 13 US$ 0.35 0.16 0.51 0.38 0.54 0.43
United Therapeutics Corp (UTHR)
US$ 89.74 — N — 75.00 Dec 13 US$ — 7.15 — 7.99 — 8.68
XenoPort (XNPT) US$ 4.27 — O — 7.00 Dec 13 US$ — (1.34) — (1.42) — (1.24)
*O – Outperform, N – Neutral, U – Underperform, R – Restricted [V] = Stock considered volatile (see Disclosure Appendix).
Source: Company data, Credit Suisse estimates.
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Exhibit 2: US/EU Biotech Market Cap Ranking (1-50)
Mkt
Cap
Rank
Mkt Cap
in $M Ticker Company name CS Rec.
Current
Price CS TP 1D Perf 1M Perf 3M Perf 12M Perf YTD Perf
Perf.
Since Feb
24th Peak
Short Interest
(% of
Outstanding) Therapeutic Area Lead Asset
1 133,604 GILD GILEAD OUTPERFORM $87 $110 -2% 9% 24% 51% 16% 4% 6.1% HIV/HCV Diversified
2 89,109 AMGN AMGEN NEUTRAL $118 $125 1% 1% 2% 13% 3% -6% 1.1% Diversified Diversified
3 72,047 BIIB BIOGEN IDEC OUTPERFORM $304 $400 -3% 0% 5% 35% 9% -12% 1.3% CNS Diversified
4 68,668 CELG CELGENE OUTPERFORM $86 $113 -1% 8% 22% 26% 2% 5% 1.9% Hem/Onc Diversified
5 31,404 ALXN ALEXION NEUTRAL $159 $174 -1% -1% 6% 46% 19% -14% 1.8% Rare Diseases Soliris
6 30,882 REGN REGENERON OUTPERFORM $306 $340 -2% 1% 3% 14% 11% -12% 3.9% Diversified Eylea
7 22,871 VRTX VERTEX NEUTRAL $97 $94 0% 47% 51% 13% 30% 15% 2.8% Cystic Fibrosis Kalydeco, VX-809
8 14,626 ATLN-VX ACTELION OUTPERFORM CHF 109 CHF 125 -1% -2% 27% 81% 45% 22% PAH Macitentan, Tracleer
9 8,226 BMRN BIOMARIN OUTPERFORM $56 $73 -2% -7% -7% -10% -20% -31% 3.3% Rare Diseases Base business and Vimizim
10 7,887 INCY INCYTE $47 -3% -15% 6% 109% -7% -30% 5.5% Oncology/Inflammatory Jakafi and Baricitinib
11 7,027 PCYC PHARMACYCLICS OUTPERFORM $94 $121 1% 1% 4% -11% -11% -38% 7.5% Oncology Ibrutinib
12 5,571 MDVN MEDIVATION OUTPERFORM $73 $95 -1% -2% 26% 29% 14% -16% 4.9% Oncology Xtandi
13 4,801 CBST CUBIST OUTPERFORM $64 $77 -3% -7% 0% 21% -7% -20% 6.0% Anti-infectives Cubicin
14 4,612 ICPT INTERCEPT $218 -1% -22% -9% 329% 219% -42% 3.8% Liver disease Obeticholic acid
15 4,350 UTHR UNITED THERAPEUTICS NEUTRAL $91 $75 -1% 5% -6% 33% -20% -13% 12.3% PAH Remodulin, Adcirca and Tyvaso
16 4,331 SGEN SEATTLE GENETICS OUTPERFORM $35 $51 0% -10% -9% -9% -12% -35% 13.9% Oncology Adcetris
17 4,110 ITMN INTERMUNE NEUTRAL $42 $33 -3% -11% 47% 216% 182% 198% 10.6% Pulmonology Esbriet
18 4,063 ALNY ALNYLAM $54 1% -23% 0% 17% -16% -39% 8.7% RNAi technology TTR-mediated amyloidosis
19 3,813 BTG-LN BTG PLC GBP 616 -2% 2% 16% 56% 7% 3% MS (RRMS) Lemtrada
20 3,762 MNKD MANNKIND $10 -2% -9% 55% 32% 86% 51% 17.5% Diabetes Afrezza
21 3,622 IDIX IDENIX RESTRICTED $24 0% 0% 340% 547% 302% 237% 9.2% HCV IDX719
22 3,385 ISIS ISIS $29 -1% -16% -15% -8% -28% -51% 11.4% Antisense technology Kynamro
23 3,036 PCRX PACIRA $85 -1% -1% 29% 151% 48% 16% 10.6% Postsurgical Analgaseia Exparel
24 3,012 NPSP NPS $28 1% -14% 15% 57% -7% -27% 6.6% Rare Diseases Gattex/Revestive; Natpara
25 2,451 GEVA SYNAGEVA $74 0% -17% -6% 56% 15% -34% 7.0% Rare Diseases Sebelipase alfa
26 2,407 MOR-XE MORPHOSYS EUR 68 -2% 0% 8% 34% 21% 3% MM, RA Anti-CD38 antibody MOR202; MOR103
27 2,313 XON INTREXON $23 2% -8% 21% -2% -6% 10.0% NA UltraVector, RTS
28 2,149 GEN-KO GENMAB DKK 209 -1% -5% 9% 16% -1% -15% CLL, MM Arzerra, Chlorambucil, and Daratumumab
29 2,004 ACAD ACADIA $20 -3% -13% 4% 2% -19% -28% 15.4% CNS Pimavanserin
30 1,933 IRWD IRONWOOD OUTPERFORM $14 $16 1% -5% 34% 25% 21% -7% 9.8% GI Linzess/Constella
31 1,933 PBYI PUMA $64 2% 6% -13% 21% -38% -51% 5.6% Oncology Neratinib
32 1,715 MDCO THE MEDICINES COMPANYNEUTRAL $26 $28 -1% -7% 7% -14% -32% -15% 6.5% Critical care Marketed products, Cangrelor
33 1,492 PDLI PDL BIOPHARMA $9 -1% -3% 10% 16% 10% 6% 19.5% Antibody technology Royalty revenues
34 1,482 NKTR NEKTAR $12 -1% -16% 6% -8% 3% -14% 5.9% Platform technology Etirinotecan pegol; NKTR-181
35 1,346 RARE ULTRAGENYX $43 2% 1% 1% -26% 4.9% XLH KRN23
36 1,340 OPHT OPHTHOTECH $40 -2% -3% 27% 24% 14% 5.2% Wet AMD Fovista
37 1,277 KERX KERYX $14 -2% -2% 4% 61% 8% -15% 21.8% Kidney disease Zerenex
38 1,275 ABC-LN ABCAM GBP 371 -1% -4% -1% -17% -24% -24% Antibodies Research antibodies
39 1,265 CLVS CLOVIS OUTPERFORM $37 $100 -3% -15% -32% -52% -38% -51% 11.3% Oncology CO-1686 and Rucaparib
40 1,256 ACOR ACORDA $30 0% -6% -13% -20% 3% -17% 11.4% CNS Ampyra
41 1,179 AGIO AGIOS $35 -8% -26% -15% 45% 15% 7.4% Mutations in the enzymes IDH2/IDH1 AG-221
42 1,177 CLDX CELLDEX $13 -2% -25% -8% -37% -46% -58% 19.4% Cancer immunotherapy Rindopepimut
43 1,144 BSLN-EB BASILEA CHF 98 0% -8% 6% 37% -7% -21% Antibiotics Isavuconazole, Ceftobiprole
44 1,144 HALO HALOZYME $9 0% -10% 21% 10% -39% -43% 13.4% Platform technology Hylenex
45 1,144 KPTI KARYOPHARM $35 -1% -22% 13% 53% -11% 7.2% Relapsed/refractory hematological/solid tumor malignanciesKPT-330
46 1,138 DYAX DYAX $8 -2% -5% 25% 103% 11% -17% 4.8% Oncology Kalbitor; Ramucirumab
47 1,099 LGND LIGAND $53 -7% -17% -17% 17% 1% -29% 16.5% Royalties Royalty Revenues
48 1,048 ARNA ARENA UNDERPERFORM$5 $4 -3% -23% -23% -34% -18% -32% 19.0% Obesity Belviq
49 1,028 TSRO TESARO INC $29 -4% 0% 14% -30% 1% -10% 6.9% Chemotherapy induced nausea and vomiting Rolapitant
50 1,023 HZNP HORIZON $14 -6% -12% 4% 429% 82% 14% 19.9% Mild-to-moderate pain/arthritisMorning stiffness with RA Duexis, Lodotra
Source: Company data, Credit Suisse estimates Priced as of July 16, 2014 close
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Exhibit 3: US/EU Biotech Market Cap Ranking (51-100)
Mkt
Cap
Rank
Mkt Cap
in $M Ticker Company name CS Rec.
Current
Price CS TP 1D Perf 1M Perf 3M Perf 12M Perf YTD Perf
Perf.
Since Feb
24th Peak
Short Interest
(% of
Outstanding) Therapeutic Area Lead Asset
51 1,013 PTLA PORTOLA OUTPERFORM $25 $34 1% -13% 5% 5% -4% -9% 4.5% Cardiovascular Betrixiban, PRT4445
52 1,003 ARIA ARIAD NEUTRAL $5 $8 -4% -16% -25% -73% -21% -38% 25.7% Oncology Iclusig, AP26113
53 995 NVAX NOVAVAX $4 -2% -7% 4% 63% -18% -30% 10.2% Anti-Infectives RSV Vaccine and VLP Influenza Vaccine
54 985 NBIX NEUROCRINE $13 -3% -13% -3% -10% 39% -27% 7.1% Diversified Elagolix; NBI-98854
55 967 IMGN IMMUNOGEN NEUTRAL $11 $14 5% -14% -19% -42% -23% -35% 10.4% Oncology Kadcyla
56 956 EPZM EPIZYME $29 -3% 1% 45% -32% 39% -8% 7.1% Oncology EPZM-5676
57 942 GNFT-FR GENFIT $29.8 7% 16% 49% 522% 237% -4% Non-alcoholic steato hepatitis GFT505
58 931 RCPT RECEPTOS OUTPERFORM $35 $58 -5% -9% -3% 86% 21% -21% 5.1% CNS RPC1063
59 874 XLRN ACCELERON $28 2% -19% -28% -30% -39% 4.0% β-thalassemia Sotatercept
60 855 SGMO SANGAMO $13 -1% -25% -10% 23% -9% -37% 14.2% HIV SB-728-T
61 841 EBS EMERGENT $22 1% 1% -12% 24% -2% -12% 8.9% Immune-therapeutics BioThrax
62 841 SRPT SAREPTA $21 -2% -37% -15% -53% 2% -31% 8.4% Rare/infectious diseases Eteplirsen
63 839 BLUE BLUEBIRD EUR 30 -7% -16% 53% -12% 45% 26% 3.2% Childhood cerebral ALD ALD-102
64 818 AEGR AEGERION $28 0% -19% -36% -65% -61% -59% 23.9% Homozygous familial Lomitapide
65 813 KITE KITE PHARMA OUTPERFORM $21.4 $34 -5% Immuno-Oncology Car T (Modified T Cells)
66 795 RLYP RELYPSA $24 0% 2% 3% -6% -43% 4.4% Hyperkalemia, Polymer drug discovery technology Patiromer, RLY6002
67 794 BCRX BIOCRYST $11.1 -4% -8% 33% 466% 46% -4% 7.9% Novel Therapy Novel drugs
68 783 LXRX LEXICON $2 -3% -11% -7% -42% -16% -19% 2.8% Diversified Telotristat etiprate; LX4211
69 773 FMI FOUNDATION MEDICINE $27 -1% 18% 3% 15% -15% 8.3% Cancer diagnostics test FOUNDATIONONE
70 728 RVNC REVANCE $31 2% 4% 11% 6% 3.4% Crow's feat lines RT001
71 727 KYTH KYTHERA $32 -2% -13% -11% 18% -14% -42% 16.3% Aesthetics ATX-101
72 717 CMRX CHIMERIX $20 0% -8% -1% -17% 34% 4% 3.9% Anti-infectives CMX-001
73 717 MDXG MIMEDIX $6.8 -4% 9% 19% 20% -23% -5% 12.8% Chronic Wound Healing AmnioFix
74 713 ENTA ENANTA OUTPERFORM $38 $43 -2% -8% 15% 106% 41% -1% 9.7% HCV ABT-450/r ) and EDP-239
75 711 EXEL EXELIXIS NEUTRAL $4 $4 0% 1% 11% -28% -40% -47% 25.0% Oncology Cometriq
76 706 PTCT PTC THERAPEUTICS OUTPERFORM $23 $40 -3% -8% 25% 32% 38% -22% 4.8% Orphan Diseases Ataluren
77 699 INSM INSMED $18 -3% 43% 33% 51% 5% -5% 10.9% Anti-infectives Arikace
78 694 ANAC ANACOR $17 0% -2% 7% 144% -1% -16% 9.3% Onychomycosis (fungal infection) AN2690
79 663 ACHN ACHILLION NEUTRAL $6.9 $4 -4% -10% 142% -3% 106% 93% 15.8% HCV HCV: Sovaprevir (Phase II, Clinical Hold); ACH3102 (Phase II)
80 658 TSRX TRIUS $14 0% 0% 0% 23% 0% 0% Acute bacterial skin and skin structure infections Torezolid phosphate
81 657 ABLX-BT ABLYNX EUR 9 1% -8% 5% 40% 29% 0% Inflammatory, Musculoskeletal Caplacizumab; ozoralizumab, ALX-0061
82 654 MACK MERRIMACK $6 -3% -18% 40% 27% 19% 27% 17.6% Oncology MM-398
83 651 EVT-XE EVOTEC EUR 4 1% 2% 5% 43% 0% -8% Cardiovascular DiaPep277; EVT302, EVT 100
84 643 VSAR VERSARTIS $26.6 1% -11% 5% 5.3% Growth hormone deficiency VRS-317
85 620 OREX OREXIGEN OUTPERFORM $5 $10 0% -15% 1% -14% -5% -26% 19.1% Obesity Contrave
86 611 OMED ONCOMED $21 -2% -18% -20% -30% -43% 6.2% Advanced solid tumorsPancreatic cancer / SCLC Demcizumab, OMP-59R5
87 606 GLPG-AE GALAPAGOS EUR 15 2% -2% -6% -10% -3% -18% Autoimmune GLPG0634
88 602 IPH-FR INNATE $8.4 4% -3% 21% 229% 69% -23% AML and other tumors Lirilumab
89 600 NLNK NEWLINK $22 -1% -13% 3% 15% -2% -57% 15.1% Oncology Algenpantucel-L, Tergenpumatucel-L
90 594 VELO-KO VELOXIS DKK 2.0 1% 6% 103% 190% 181% 149%
91 585 INO INOVIO $10 0% 6% -4% 103% -16% -35% 16.3% Oncology, Anti-Infectives DNA-based SynCon Technology
92 576 MNTA MOMENTA $10.9 0% -16% -2% -28% -38% -38% 11.9% Deep Vein Thrombosis Enoxaprin Sodium Injection
93 570 MVIR'B-SK MEDIVIR AB-B OUTPERFORM SEK 127 SEK 115 -6% -9% 17% 76% 50% 17% HCV Simeprevir
94 561 BAVA-KO BAVARIAN NORDIC DKK 118.5 0% -2% 22% 93% 33% 16% Vaccine Prostvac; Imvamune
95 560 RPTP RAPTOR $9 -4% -22% 9% -16% -31% -46% 22.2% Cystinosis Procysbi; RP103
96 544 AERI AERIE $23.2 -3% 24% 55% 29% 16% 2.4% Glaucoma patients AR-13324PG324
97 538 PLI-T PROMETIC LIFE $1.1 1% -3% -11% 191% 17% -27% Fibrosis PBI-4050
98 526 ASPX AUSPEX $20 -1% -9% -6% -22% 2.0% Chorea associated with Huntington's disease SD-809
99 526 MGNX MACROGENICS $19 -2% -13% -5% -31% -46% 2.0% HER2 metastic breast cancer MGAH22
100 507 PRTA-US PROTHENA OUTPERFORM $19 $53 -3% -17% -38% 12% -28% -39% 5.0% Neurological NEOD001, PRX002
Source: Company data, Credit Suisse estimates Priced as of July 16, 2014 close
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Exhibit 4: CS Biotech Team – 50 Companies Under Coverage
Company Name Ticker
Market Cap
($M) CS Rating
CS
Target Price Last Price Coverage Company Name Ticker
Market Cap
($M) CS Rating
CS
Target Price Last Price Coverage
Large Cap Hospital Antibiotics
Amgen Inc AMGN $89,109 NEUTRAL $125.00 $117.71 RM/KC Achaogen Inc AKAO $208 OUTPERFORM $22.00 $11.75 JK/JS
Biogen Idec Inc BIIB $72,047 OUTPERFORM $400.00 $303.74 RM/KC Cubist Pharmaceuticals Inc CBST $4,801 OUTPERFORM $77.00 $63.76 JK/JS
Celgene Corp CELG $68,668 OUTPERFORM $112.50 $86.05 RM/KC Durata Therapeutics Inc DRTX $402 OUTPERFORM $22.00 $15.09 JK/JS
Gilead Sciences Inc GILD $133,604 OUTPERFORM $110.00 $87.00 RM/KC Medicines Co MDCO $1,715 NEUTRAL $28.00 $26.38 JK/JS
SMID Cap Obesity
Antibody Arena Pharmaceuticals Inc ARNA $1,048 UNDERPERFORM $4.00 $4.77 LK/RM
Alder Biopharmaceuticals Inc ALDR $463 OUTPERFORM $20.00 $15.03 JK/JS Orexigen Therapeutics Inc OREX $620 OUTPERFORM $10.00 $5.33 LK/RM
Immunogen Inc IMGN $967 NEUTRAL $14.00 $11.27 JK/JS Vivus Inc VVUS $478 NEUTRAL $6.00 $4.63 LK/RM
Regeneron Pharmaceuticals Inc REGN $30,269 OUTPERFORM $340.00 $306.12 JK/JS Oncology SMID
Seattle Genetics Inc SGEN $4,331 OUTPERFORM $51.00 $35.17 JK/JS ARIAD Pharmaceuticals Inc ARIA $1,003 NEUTRAL $8.00 $5.37 JK/JS
XOMA Corp XOMA $418 NEUTRAL $7.00 $3.91 JK/JS BIND Therapeutics Inc BIND $174 OUTPERFORM $20.00 $10.56 JK/JS
Prothena Corporation PLC PRTA $507 OUTPERFORM $53.00 $19.01 JK/JS Clovis Oncology Inc CLVS $1,265 OUTPERFORM $100.00 $37.30 RM/KC
Xencor Inc XNCR $328 OUTPERFORM $14.00 $10.45 JK/JS Endocyte Inc ECYT $259 OUTPERFORM $9.00 $6.25 JK/JS
Commercial-Stage SMID Infinity Pharmaceuticals Inc INFI $490 NEUTRAL $20.00 $10.09 JK/JS
Actelion Ltd ATLN-VX $14,830 OUTPERFORM CHF 125.00 CHF 109.20 RM/KC Kite Pharma Inc KITE $796 OUTPERFORM $34.00 $21.39 JK/JS
Corcept Therapeutics Inc CORT $240 NEUTRAL $2.00 $2.38 RM/KC Pharmacyclics Inc PCYC $7,027 OUTPERFORM $121.00 $93.66 JK/JS
InterMune Inc ITMN $4,110 NEUTRAL $33.00 $41.56 RM/KC Sunesis Pharmaceuticals Inc SNSS $341 NEUTRAL $6.00 $5.66 JK/JS
United Therapeutics Corp UTHR $4,350 NEUTRAL $75.00 $90.68 RM/KC Orphan Drugs
Xenoport Inc XNPT $274 OUTPERFORM $7.00 $4.43 RM/KC Alexion Pharmaceuticals Inc ALXN $31,404 NEUTRAL $174.00 $158.77 LK/RM
Constipation / IBS-C BioMarin Pharmaceutical Inc BMRN $8,222 OUTPERFORM $73.00 $56.37 LK/RM
Ironwood Pharmaceuticals Inc IRWD $1,673 OUTPERFORM $16.00 $14.00 RM/KC PTC Therapeutics Inc PTCT $706 OUTPERFORM $40.00 $23.48 JK/JS
Sucampo Pharmaceuticals Inc SCMP $283 NEUTRAL $8.00 $6.39 RM/KC Prostate Cancer
Synergy Pharmaceuticals Inc SGYP $362 OUTPERFORM $9.20 $3.86 RM/KC Dendreon Corp DNDN $347 NEUTRAL $2.50 $2.17 LK/RM
Development-Stage SMID Exelixis Inc EXEL $711 NEUTRAL $4.00 $3.65 LK/RM
Akebia Therapeutics Inc AKBA $485 OUTPERFORM $25.00 $23.95 RM/KC Medivation Inc MDVN $5,571 OUTPERFORM $95.00 $72.80 LK/RM
Esperion Therapeutics Inc ESPR $216 OUTPERFORM $26.00 $14.03 JK/JS * Last Price as of July 16th, 2014
Portola Pharmaceuticals Inc PTLA $1,014 OUTPERFORM $34.00 $24.65 JK/JS
Receptos Inc RCPT $931 OUTPERFORM $58.00 $35.00 RM/KC
Vical Inc VICL $105 NEUTRAL $1.50 $1.21 LK/RM
HCV
Achillion Pharmaceuticals Inc ACHN $663 NEUTRAL $4.00 $6.85 RM/KC
Enanta Pharmaceuticals Inc ENTA $713 OUTPERFORM $43.00 $38.44 RM/KC
Idenix Pharmaceuticals Inc IDIX $3,622 RESTRICTED $24.01 RM/KC
Medivir AB MVIR'B-SK $3,886 OUTPERFORM SEK 115.00 SEK 127.00 RM/KC
Vertex Pharmaceuticals Inc VRTX $22,871 NEUTRAL $94.00 $96.83 RM/KC
Source: Company data, Credit Suisse estimates
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Exhibit 5: 2014 YTD Biotech (dark blue) vs. major sectors on a biweekly basis
Jan 1 - Jan
15
Jan 15 -
Jan 31
Feb 1 - Feb
15
Feb 15 -
Feb 28
Mar 1 - Mar
15
Mar 15 -
Mar 31
Apr 1 - Apr
15
Apr 15 -
Apr 30
May 1 -
May 15
May 15 -
May 31
Jun 1 - Jun
15
Jun 15 -
Jun 30
Jul 1 -
Jul 15
Healthcare Utilities Biotech Cons Disc Utilities Telecom Utilities Biotech Telecom Biotech Energy Utilities Telecom
3% 3% 5% 2% 1% 6% 3% 5% 3% 5% 3% 5% 4%
Biotech Biotech Materials Healthcare Financials Energy Energy Energy Biotech IT Financials Biotech IT
2% 3% 5% 2% 0% 4% 2% 3% 0% 4% 1% 3% 3%
Financials Telecom IT Materials Cons Stap Financials Cons Stap Industrials Materials Cons Disc IT Healthcare Industrials
1% -2% 4% 2% 0% 3% 0% 3% 0% 4% 1% 2% 1%
IT Healthcare Healthcare Energy Materials Industrials Telecom Healthcare Industrials Healthcare Industrials Cons Disc Biotech
1% -2% 4% 2% 0% 2% 0% 3% 0% 3% 1% 2% 1%
S&P 500 IT Cons Disc S&P 500 Telecom IT Materials IT Energy Materials S&P 500 Energy Cons Disc
0% -3% 4% 1% -1% 2% -1% 2% 0% 3% 1% 2% 1%
Industrials S&P 500 S&P 500 Cons Stap S&P 500 Utilities Industrials Cons Stap Healthcare S&P 500 Materials Materials S&P 500
0% -4% 3% 1% -1% 2% -1% 2% 0% 3% 0% 1% 1%
Utilities Energy Energy Industrials Industrials S&P 500 S&P 500 S&P 500 Cons Stap Financials Cons Disc S&P 500 Financials
0% -4% 3% 1% -1% 2% -2% 2% -1% 3% 0% 1% 1%
Materials Cons Stap Financials Biotech Energy Cons Stap IT Materials S&P 500 Cons Stap Biotech IT Cons Stap
-1% -4% 3% 1% -1% 2% -2% 2% -1% 2% 0% 1% 1%
Cons Stap Materials Utilities IT Cons Disc Materials Cons Disc Cons Disc IT Industrials Healthcare Financials Energy
-1% -4% 3% 0% -2% 1% -3% 2% -1% 2% 0% 1% 1%
Cons Disc Cons Disc Industrials Financials Healthcare Healthcare Financials Utilities Cons Disc Utilities Utilities Cons Stap Materials
-2% -4% 3% 0% -2% 0% -3% 2% -1% 2% -1% 0% 0%
Energy Industrials Cons Stap Utilities IT Cons Disc Healthcare Financials Financials Energy Cons Stap Telecom Healthcare
-3% -4% 2% 0% -2% -1% -3% 2% -1% 2% -1% 0% 0%
Telecom Financials Telecom Telecom Biotech Biotech Biotech Telecom Utilities Telecom Telecom Industrials Utilities
-3% -5% -1% 0% -5% -6% -5% 0% -3% 1% -1% -1% -3%
Source: Company data, Credit Suisse estimates
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Exhibit 6: YTD Performance of Large, Mid, Small and Micro Cap Indices
80
90
100
110
120
130
140
Jan-14 Feb-14 Mar-14 Apr-14 May-14 Jun-14 Jul-14
Re
lati
ve
YT
D P
erf
orm
an
ce
Large: $30Bn+ Mkt Cap Mid: $3 - $30 Bn Mkt Cap Small: $1 - $3 Bn Mkt Cap Micro: < $1 Bn Mkt Cap
Micro: < $1B Mkt Cap
Small: $1B - $3 Mkt Cap
Mid: $3B - $30 Mkt Cap
Large: $30B+ Mkt Cap+9%
+5%+2%
-5%
Source: Company data, Credit Suisse estimates Comapanies sorted by market cap on Jan 1st, 2014.
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Exhibit 7: Biotech vs. Major Sectors Index Performance*
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 YTD
Biotech Biotech Utilities Cons Disc Cons Stap IT Energy Energy Telecom Energy Biotech IT Cons Disc Biotech Biotech Biotech Utilities
93% 130% 52% 2% -6% 47% 29% 29% 32% 32% 10% 60% 26% 22% 38% 74% 12%
IT IT Healthcare Materials Materials Cons Disc Utilities Biotech Energy Materials Cons Stap Materials Industrials Utilities Financials Cons Disc Energy
78% 78% 36% 1% -8% 36% 20% 18% 22% 20% -18% 45% 24% 15% 26% 41% 12%
Telecom Cons Disc Financials Biotech Energy Materials Industrials Utilities Cons Disc Utilities Healthcare Cons Disc Materials Cons Stap Cons Disc Healthcare IT
49% 24% 23% -4% -13% 35% 16% 13% 17% 16% -24% 39% 20% 11% 22% 39% 11%
Healthcare Materials Cons Stap Industrials Financials Industrials Telecom Healthcare Utilities IT Utilities S&P 500 Energy Healthcare Healthcare Industrials Biotech
42% 23% 14% -7% -16% 30% 16% 5% 17% 16% -32% 23% 18% 10% 15% 38% 10%
Cons Disc Industrials Energy Cons Stap Healthcare Biotech Cons Disc Financials Financials Cons Stap Telecom Industrials S&P 500 Cons Disc S&P 500 Financials Healthcare
40% 20% 13% -8% -20% 29% 12% 4% 16% 12% -34% 17% 13% 4% 13% 33% 10%
S&P 500 S&P 500 Industrials Financials Biotech Financials Materials S&P 500 Materials Industrials Cons Disc Healthcare Telecom Energy IT S&P 500 Materials
27% 20% 5% -11% -20% 28% 11% 3% 16% 10% -35% 17% 12% 3% 13% 30% 8%
Cons Stap Telecom Biotech Energy S&P 500 S&P 500 S&P 500 Materials S&P 500 Telecom Energy Financials Financials IT Telecom IT S&P 500
14% 17% -5% -12% -23% 26% 9% 2% 14% 8% -36% 15% 11% 1% 12% 26% 7%
Utilities Energy S&P 500 Healthcare Cons Disc Energy Financials Cons Stap Cons Stap Healthcare S&P 500 Energy Cons Stap Telecom Industrials Materials Telecom
10% 16% -10% -13% -24% 22% 8% 1% 12% 5% -38% 11% 11% 1% 12% 23% 5%
Financials Financials Materials S&P 500 Industrials Utilities Biotech IT Industrials S&P 500 Industrials Cons Stap IT S&P 500 Materials Cons Stap Financials
10% 2% -18% -13% -28% 21% 8% 0% 11% 4% -42% 11% 9% 0% 12% 23% 5%
Industrials Healthcare Cons Disc Telecom Utilities Healthcare Cons Stap Industrials IT Biotech IT Utilities Biotech Industrials Cons Stap Energy Cons Stap
9% -12% -21% -14% -33% 13% 6% 0% 8% -3% -44% 7% 2% -3% 8% 22% 5%
Energy Utilities Telecom IT Telecom Cons Stap IT Cons Disc Healthcare Cons Disc Materials Telecom Utilities Materials Energy Utilities Industrials
-2% -13% -40% -26% -36% 9% 2% -7% 6% -14% -47% 3% 1% -12% 2% 9% 4%
Materials Cons Stap IT Utilities IT Telecom Healthcare Telecom Biotech Financials Financials Biotech Healthcare Financials Utilities Telecom Cons Disc
-8% -17% -41% -32% -38% 3% 0% -9% -3% -21% -57% -7% 1% -18% -3% 6% 1%
Source: Company data, Credit Suisse estimates *Sector Performance derived using S&P500 Sector Indices
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Exhibit 8: Healthcare Sub-sector Performance*
1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 YTD
Biotech Biotech Distributors Distributors Mgd Care Mgd Care Mgd Care Mgd Care S&P 500 Services Biotech Lifesci tools Lifesci tools Mgd Care Biotech Biotech Mgd Care
93% 130% 85% -1% 1% 41% 53% 43% 14% 57% 10% 57% 24% 33% 38% 74% 15%
Distributors S&P 500 Mgd Care Biotech Equip/Sup Equip/Sup Services Services Pharma Lifesci tools Services Distributors Distributors Biotech Lifesci tools Distributors Equip/Sup
54% 20% 77% -4% -13% 31% 17% 32% 13% 23% -17% 44% 18% 22% 30% 62% 11%
Pharma Equip/Sup Equip/Sup Equip/Sup Distributors Biotech Equip/Sup Distributors Healthcare Mgd Care Pharma Services S&P 500 Pharma Services Lifesci tools Pharma
47% -5% 43% -6% -14% 29% 12% 29% 6% 16% -21% 41% 13% 13% 20% 52% 10%
Equip/Sup Mgd Care Healthcare Mgd Care Healthcare S&P 500 S&P 500 Biotech Services Healthcare Healthcare Mgd Care Mgd Care Healthcare Healthcare Mgd Care Distributors
42% -9% 36% -8% -20% 26% 9% 18% 5% 5% -24% 28% 8% 10% 15% 46% 10%
Healthcare Healthcare Pharma Healthcare Biotech Healthcare Biotech Healthcare Equip/Sup Equip/Sup Equip/Sup Equip/Sup Services Distributors Equip/Sup Healthcare Biotech
42% -12% 34% -13% -20% 13% 8% 5% 3% 5% -28% 27% 8% 8% 15% 39% 10%
S&P 500 Pharma Biotech S&P 500 Pharma Distributors Healthcare S&P 500 Distributors Distributors Distributors S&P 500 Biotech S&P 500 Distributors Pharma Healthcare
27% -13% -5% -13% -22% 8% 0% 3% -2% 4% -38% 23% 2% 0% 15% 31% 10%
Mgd Care Distributors S&P 500 Pharma S&P 500 Pharma Distributors Equip/Sup Biotech S&P 500 S&P 500 Healthcare Healthcare Equip/Sup S&P 500 S&P 500 S&P 500
-10% -59% -10% -16% -23% 6% -3% 0% -3% 4% -38% 17% 1% -2% 13% 30% 7%
Lifesci tools Lifesci tools Lifesci tools Lifesci tools Lifesci tools Lifesci tools Pharma Pharma Mgd Care Pharma Lifesci tools Pharma Pharma Services Pharma Equip/Sup Lifesci tools
N/A N/A N/A N/A N/A N/A -9% -6% -7% 2% -39% 14% -3% -8% 11% 26% 4%
Services Services Services Services Services Services Lifesci tools Lifesci tools Lifesci tools Biotech Mgd Care Biotech Equip/Sup Lifesci tools Mgd Care Services Services
N/A N/A N/A N/A N/A N/A N/A N/A N/A -3% -55% -7% -4% -18% 5% 20% 1%
Source: Company data, Credit Suisse estimates *Sector Performance derived using S&P500 Sector Indices
18 July 2014
Global Biotechnology 10
Exhibit 9: YTD Performance S&P500 vs. S&P500 Biotech
100
120
140
160
180
200
220
S&P 500 S&P500 Biotech
Source: Company data, Credit Suisse estimates
Exhibit 10: Biotech is trading at a discount to the S&P 500 on 2016 and 2017 PE despite ~4x EPS growth rates
Company 2014 P/E 2015 P/E 2016 P/E 2017 P/E Rev CAGR '14-'17 (%) EPS CAGR '14-'17 (%)
AMGN 14.3x 13.8x 13.5x 12.1x 1% 6%
BIIB 27.3x 22.4x 19.1x 16.7x 11% 18%
CELG 24.2x 18.2x 13.8x 11.2x 20% 29%
GILD 12.4x 12.0x 10.7x 10.4x 6% 6%
LC Biotech Average 19.6x 16.6x 14.3x 12.6x 9.5% 14.8%
US Pharma Average 19.2x 18.2x 15.6x 13.9x 3.9% 11.5%
EU Pharma Average 18.6x 17.1x 15.6x 15.3x 3.7% 8.1%
S&P 500 16.9x 15.6x 15.0x 14.4x 5.2% 5.6%
Source: Company data, Credit Suisse estimates
Exhibit 11: Biotech Has Sector Leading Revenue and EPS Growth
Sector Revenues YoY Growth EPS YoY Growth
2014 2015 2016 2017 2014 2015 2016 2017
Biotech 38% 12% 11% 6% 76% 16% 16% 13%
Consumer Discretionary 11% 9% 10% 7% 3% 148% 41% 30%
Telecom 7% 2% 2% 0% 22% 22% 14% -4%
IT 6% 11% 10% 1% 9% 16% 14% 3%
Materials 4% 6% 5% 3% 18% 24% 15% 1%
Utilities 4% 3% 3% 0% 5% 5% 4% 5%
S&P 500 3% 5% 4% 6% 8% 8% 4% 5%
Industrials 2% 4% 6% 6% 9% 11% 11% 11%
Energy 2% 3% 4% 1% 11% 15% -3% 6%
Consumer Staples 0% 3% 4% 4% 1% 6% 8% 11%
Financials 0% 3% 4% 7% 4% 20% 8% 9%
Pharma -2% -1% 4% 4% 3% 2% 13% 11%
Source: Company data, Credit Suisse estimates
18 July 2014
Global Biotechnology 11
Large-Cap Biotech
■ BIIB (TP$400, Outperform) – Pre-open release/call at 9:00am ET on Wednesday
7/23: For Q2 earnings, we are in-line on revenues (CS: $2.15B/+25% Y/Y vs.
Consensus: $2.14B/+24%) and EPS (CS: $2.79/+21% vs. Consensus: $2.80/+22%).
Tecfidera remains a key area of focus, with specific attention on the recent EU launch.
We currently estimate Q2 Tecfidera sales of $570M/+197% (vs. $556M/+189% for
consensus), Tysabri sales of $419M/+8% (vs. $442M/+14% for consensus) and
Avonex sales of $761M/-2% (vs. $744M/-4% for consensus). We expect most of the
call will be focused on: (1) Early experience from the recent US launch of Alprolix in
Hemophilia B and preparations for recently FDA-approved Eloctate in Hemophilia A;
(2) Granularity on the Tecfidera launch/ramp in the EU; (3) Any visible impact from the
February-launched 3-times-a-week Copaxone, and potential impact from a '14/'15
generic Copaxone launch; and (4) Whilst no significant updates on the pipeline are
expected we expect (continued) call attention on particularly Anti-LINGO-1 (RENEW
PIII trial in AON due in Dec) and Tysabri (ASCEND PIII trial in SPMS due mid 2015).
■ GILD (TP$110, Outperform) – Post-close release/call at 4:30pm ET on
Wednesday 7/23: The most important headline number is Sovaldi Q2 revenues. We
are forecasting WW Sovaldi Q2 sales of $2.98B, which is slightly above consensus of
$2.92B. Based on IMS Rx data, we estimate US Sovaldi Q2 sales of $2.61B, which is
comprised of in-demand sales (adjusted by our capture rate) of $2.56B and inventory
stocking of $53M. This sales estimate assumes a WAC price of $1,000 per pill and a
15.0% gross-to-net adjustment. On high-level financial metrics, we are slightly above
consensus on both total revenues (CS: $6.00B/+117% Y/Y vs. Consensus:
$5.67B/+105% Y/Y) and EPS (CS: $1.87/+296% Y/Y vs. Consensus: $1.70 Y/Y
+265%). For the HIV franchise, we project Atripla sales of $891M/-5% (vs. $893M/-5%
for consensus), Truvada sales of $779M/-4% (vs. $800M/-1% for consensus), Viread
sales of $260M/+4% (vs. $240M/-4% for consensus), Stribild sales of $262M/+164%
(vs. $260M/+162% for consensus), and Complera sales of $287M/+52% (vs.
$280M/+48% for consensus). We anticipate that the majority of the call to be centered
on: (1) Pricing strategy for Sofosbuvir/Ledipasvir in HCV especially in light of recent
political scrutiny of Sovaldi's pricing; (2) Granularity on Sovaldi launch dynamics in the
US specifically on "anticipatory" warehousing as all-oral, interferon regimens are
expected to launch later this year; (3) Further details on the mid- to long-term strategy
to build a sustainable HCV market; (4) Potential impact of TAF on sustaining GILD's
position in HIV in the face of generics later in the decade (5) “What's next?” after HCV
and (6) Agency cost/Capital allocation/M&A.
■ CELG (TP$112.5, Outperform) – Pre-open release/call at 9:00am ET on Thursday
7/24: We are forecasting both in-line total revenues (CS: $1.85B/+15% Y/Y vs.
Consensus: $1.84B/+15% Y/Y) and EPS (CS: $0.91/+19% Y/Y for CS vs. Consensus:
$0.89/+17% Y/Y). Revlimid continues to be the primary focus. We project Revlimid
sales ($1.22B/+16%) to be in-line with consensus ($1.22B/+16%). In addition, we are
in-line on sales for Abraxane (CS: $207M/+34% vs. Consensus: $212M/+37%),
Pomalyst/Imnovid (CS: $157M/+138% vs. Consensus: $149M/+126%) and Otzela
(CS: $1.5M vs. Consensus: $4M). Based on IMS Rx data, we estimate in-demand
Otezla sales to be $6.5M. Recall, CELG will be using the sell-through method to report
Otezla sales during the early phases of the launch. Our estimates are based on a
WAC price of $1,627 per Rx, 15% gross to net discount, and ~4000 Rx's (~61
pills/TRx). We expect the call to be focused primarily on: (1) Updates on the ongoing
Revlimid patent litigation case against Actavis/Natco; (2) Details on the US launch
dynamics for Otezla in psoriatic arthritis; (3) Granularity on ongoing launches of
Abraxane in pancreatic cancer and Pomalyst/Imnovid in multiple myeloma and (of
course!)…(4) Domain Domination and the pipeline particularly on MOR-202 (data is
expected to be released in multiple myeloma at ASH in December 2014) and GED-
18 July 2014
Global Biotechnology 12
0301 (detailed PII data in Crohn's Disease is expected to be released at UEG in
October 2014).
■ AMGN (TP$125, Neutral) – Post-close release/call at 5:00pm ET on Tuesday 7/29:
Our Q2 earnings estimates are slightly above consensus on total revenues (CS:
$5.05B +8% Y/Y vs. Consensus: $4.92B +5% Y/Y) and EPS (CS: $2.14/+13% vs.
Consensus: $2.07/+10%). We are forecasting sales of $1.49B/+0% for
Neupogen/Neulasta (vs. $1.42B/-3% for consensus), $1.22B/+5% for Enbrel (vs.
$1.18B/+2% for consensus), $565M/+30% for Prolia/Xgeva (vs. $537M/+22% for
consensus), $490M/-2% for Epogen (vs. $482M/-4% for consensus), and $101Mfor
Kyprolis (vs. $81Mfor consensus). We expect the call to be focused on the following
topics: (1) Updates on the upcoming ASPIRE and FOCUS PIII data readouts for
Kyprolis; (2) Potential impact from possible launches of Roche's Mircera as early as
July 2014 and EPO biosimilars in Mid'15; (3) Updates on the commercial strategy and
timelines for Evolocumab and Ivabradine.
18 July 2014
Global Biotechnology 13
Exhibit 12: AMGN – CS vs. Consensus Q2'14 Estimates and FY’14 Estimates
In $M except for EPSCS
Q2'14EYoY Growth
Consensus
Q2'14EYoY Growth
CS vs. Cons
Δ
CS
FY'14EYoY Growth
Consensus
FY'14EYoY Growth
CS vs. Cons
Δ
Enbrel 1,218 5% 1,182 2% 3% 4,576 1% 4,588 1% 0%
Neulasta 1,185 6% 1,123 0% 6% 4,630 5% 4,473 2% 4%
Neupogen 300 -7% 304 -6% -1% 1,179 -16% 1,185 -15% -1%
Epogen 490 -2% 482 -4% 2% 1,832 -6% 1,868 -4% -2%
Aranesp 465 -11% 465 -11% 0% 1,760 -8% 1,803 -6% -2%
Sensipar 273 5% 279 8% -2% 1,113 2% 1,129 4% -1%
Nplate 117 11% 128 22% -9% 466 9% 507 19% -8%
Prolia 245 30% 229 22% 7% 941 26% 898 21% 5%
Xgeva 320 29% 308 24% 4% 1,304 28% 1,253 23% 4%
Vectibix 110 18% 104 12% 6% 440 13% 425 9% 4%
Kyprolis 101 - 82 - 23% 453 538% 344 385% 32%
Revenue 5,054 8% 4,923 5% 3% 19,597 5% 19,418 4% 1%
Gross Product Margin 84.4% -6bp 84.2% -26bp 20bp 84.4% 13bp 84.1% -12bp 25bp
R&D 1,082 15% 1,031 9% 5% 4,240 8% 4,178 6% 1%
SG&A 1,096 -11% 1,091 -1% 0% 4,318 -12% 4,309 -12% 0%
Operating Income 2,109 18% 2,051 15% 3% 8,061 16% 7,954 14% 1%
Tax Rate 15.5% 380bp 15.6% 390bp -10bp 15.5% 646bp 15.2% 617bp 29bp
Net Income 1,647 14% 1,596 11% 3% 6,273 8% 6,211 7% 1%
Total Shares Outstanding 768 1% 766 0% 0% 768 0% 768 0% 0%
EPS (Pre-Option) $2.14 13% $2.08 10% 3% $8.17 8% $8.09 6% 1% Source: Amgen, Thomson Reuters, Credit Suisse estimates, Bloomberg
Exhibit 13: BIIB – CS vs. Consensus Q2'14 Estimates and FY’14 Estimates In millions except for
EPS
CS
Q2'14EYoY Growth
Consensus
Q2'14EYoY Growth
CS vs. Cons
Δ
CS
FY'14EYoY Growth
Consensus
FY'14EYoY Growth
CS vs. Cons
Δ
Avonex $761 -2% $744 -4% 2% $2,981 -1% $2,939 -2% 1%
Tecfidera $570 197% $556 189% 3% $2,361 169% $2,373 171% -1%
Tysabri $419 8% $442 14% -5% $1,703 12% $1,796 18% -5%
Fampyra $20 16% $20 19% -3% $80 9% $82 11% -2%
Rituxan $299 4% $296 2% 1% $1,196 6% $1,209 7% -1%
Fumaderm $16 0% $16 1% -2% $64 6% $65 8% -2%
Revenues $2,150 25% $2,142 24% 0% $8,822 27% $8,875 28% -1%
Gross Product Margin 86.9% 29bp 86.7% 9bp 20bp 86.9% -73bp 86.8% -83bp 10bp
R&D $438 34% $442 35% -1% $1,868 30% $1,902 32% -2%
SG&A $511 19% $492 14% 4% $2,036 19% $2,024 19% 1%
Operating Income $924 25% $924 25% 0% $3,778 32% $3,777 32% 0%
Tax Rate 26.7% 238bp 27.1% 278bp -40bp 26.7% 231bp 26.9% 253bp -22bp
Net Income $665 21% $666 21% 0% $2,720 27% $2,736 28% -1%
Total Shares Out 238 0% 238 0% 0% 238 0% 237 -1% 1%
EPS (Pre-Option) $2.79 21% $2.80 22% 0% $11.42 27% $11.52 28% -1% Source: Biogen Idec, Thomson Reuters, Credit Suisse estimates, Bloomberg
18 July 2014
Global Biotechnology 14
Exhibit 14: CELG – CS vs. Consensus Q2'14 Estimates and FY’14 Estimates
In millions except EPSCS
Q2'14EYoY Growth
Consensus
Q2'14EYoY Growth
CS vs. Cons
Δ
CS
FY'14EYoY Growth
Consensus
FY'14EYoY Growth
CS vs. Cons
Δ
Revlimid $1,218 16% $1,216 16% 0% $4,900 14% $4,925 15% (1%)
Abraxane $207 34% $212 37% (2%) $867 33% $881 36% (2%)
Pomalyst/Imnovid $157 138% $149 126% 5% $663 117% $624 104% 6%
Thalomid/Thalomide $52 -21% $52 -21% 0% $212 -13% $202 -17% 5%
Vidaza $152 -28% $147 -30% 3% $605 -25% $596 -26% 2%
Revenue $1,847 15% $1,838 15% 0% $7,492 15% $7,539 16% (1%)
Gross Product Margin 95.2% 14bp 95.0% -6bp 20bp 95.3% 21bp 95.1% 6bp 16bp
R&D $391 14% $413 20% (5%) $1,712 14% $1,688 12% 1%
SG&A $421 10% $423 10% (0%) $1,688 11% $1,716 13% (2%)
Operating Income $947 19% $913 15% 4% $3,737 19% $3,773 20% (1%)
Tax Rate 16.6% -50bp 16.6% -50bp 0bp 16.5% -26bp 16.6% -21bp -6bp
Net Income $765 17% $745 14% 3% $3,020 18% $3,074 20% (2%)
Total Shares 842 -2% 841 -2% 0% 841 -2% 840 -2% 0%
EPS (Pre-Option) $0.91 19% $0.89 17% 2% $3.59 20% $3.66 23% (2%) Source: Celgene, Thomson Reuters, Credit Suisse estimates, Bloomberg
Exhibit 15: GILD – CS vs. Consensus Q2'14 Estimates and FY’14 Estimates
In millions except EPSCS
Q2'14EYoY Growth
Consensus
Q2'14EYoY Growth
CS vs. Cons
Δ
CS
FY'14EYoY Growth
Consensus
FY'14EYoY Growth
CS vs. Cons
Δ
Key Products:
Atripla $891 -5% $893 -5% (0%) $3,460 -5% $3,420 -6% 1%
Truvada $779 -4% $800 -1% (3%) $3,104 -1% $3,142 0% (1%)
Viread $260 4% $240 -4% 8% $1,014 6% $929 -3% 9%
Complera $287 52% $280 48% 3% $1,184 46% $1,142 41% 4%
Stribild $262 164% $260 162% 1% $1,149 113% $1,110 106% 3%
Sofosbuvir/Ledipasvir $2,975 - $2,919 - - $10,774 7627% $10,131 7166% 6%
Product Sales $5,845 120% - - - $22,269 106% - - -
Revenue $6,000 117% $5,678 105% 6% $22,735 103% $22,236 99% 2%
Gross Margins 88.8% 1267bp 84.7% 858bp 410bp 85.4% 1055bp 83.8% 893bp 161bp
R&D $552 13% - - - $2,225 14% - - -
SG&A $528 40% - - - $2,132 37% - - -
Operating Income $4,248 242% $3,740 201% 14% $15,886 218% $14,383 188% 10%
Tax Rate 22.7% -548bp 22.6% -558bp 11bp 22.8% -362bp 20.2% -623bp 13%
Net Income $3,140 293% $2,754 245% 14% $11,698 258% $10,872 233% 8%
Total Shares Out 1,682 -1% 1,601 -6% 5% 1672 -1% 1,660 -2% 1%
EPS (Pre-Option) $1.87 296% $1.72 265% 9% $7.00 262% $6.55 239% 7%
EPS (Post-Option) $1.91 285% - - - $7.16 250% - - - Source: Gilead, Thomson Reuters, Credit Suisse estimates, Bloomberg
18 July 2014
Global Biotechnology 15
Exhibit 16: Large-Cap Revenue and Earnings Guidance
Revenue Guidance Earnings Guidance
AMGN 2014: $19.2B - $19.6B
2015: Upper End of $16 - $18B
2014 EPS: $7.90 - $8.20
2015 EPS: >$8.00
BIIB 2014: ~26%-28% ($8.7B - $8.9B) 2014 EPS: Similar to Topline Growth: 26%-28%
($11.30 - $11.50)
CELG
(Pre Stock
Split)
2014: ~$7.5B
2015: $8.5B - $9.5B
2017: $13B - $14B
2014 EPS: $7.00 - $7.20
2015 EPS: $9.00 - $9.50
2017 EPS: ~$15.00
GILD 2014: $11.3B - $11.5B (excluding Sovaldi) 2014 "Implied" EPS: $2.16 - $2.60 (excluding
Sovaldi)
Source: FactSet, Company data, Credit Suisse estimates
18 July 2014
Global Biotechnology 16
Small-Mid Cap Stocks
■ ACHN (TP$4, Neutral) – Release/call likely in early August: The Q2 financials for
ACHN, a development-stage company, will likely not have a material impact on the
stock. ACHN is still working on finding the right combination to compete in HCV. Given
Merck's announced acquisition of Idenix in June 2014 and competitiveness of the
process, we expect that investors are likely to focus on any updates concerning
ACHN's 2nd
generation uridine nuc inhibitor, ACH-3422. ACH-3422 just entered PI
proof-of-concept trials with data expected in Fall 2014. We also expect continued
focus on ACHN's planned all-oral, interferon-free combinations – ACH-3422 + ACH-
3102 +/- Protease Inhibitor in G1/2/3/4/5/6 and ACH-2684 + ACH-3102 in G1b. An
ongoing PII trial examining Sofosbuvir + ACH-3102 could allow ACHN to expedite the
clinical development of ACH-3422 + ACH-3102 +/- Protease Inhibitor in G1/2/3/4/5/6
in early 2015.
■ AKAO (TP$22, Outperform) – Call likely in the first half of August: AKAO is
currently not an earnings driven story. Investors will be most focused on (1) progress
of the Phase III study of plazomicin, (2) updates on any FDA discussions, (3) updates
for plans for the "supportive" Phase II plazomicin study, and (4) any updates for the
Pseudomonas program. We forecast GAAP Q2 EPS of ($0.44) vs. consensus of
($0.30).
■ AKBA (TP$25, Outperform) – Release/call likely in early August: AKBA is
currently not an earnings driving story. The spotlight remains on AKB-6548, which
could offer a more effective way to maintain/modulate Hb and improve upon
cardiovascular safety. The highly effective ESAs are currently relegated to treat more
severe anemia because of FDA/EMA restrictions on their use due to cardiovascular
safety concerns. Despite these concerns, the WW ESA market for anemia is still
substantial at ~$6B, of which the majority (~$4B) is generated from CKD-ND and
CKD-D. The current PIIa data have shown that AKB-6548 can increase Hb levels
gradually in a clinically meaningful way without highly elevated levels of EPO,
improves iron metabolism allowing for the potential to remove iron supplementation,
and appears to be generally safe and well-tolerated. We expect focus to be on an
updates regarding the CI-0007 PIIb trial, which is due in Q4'14 and remains the key
valuation-inflection catalyst.
■ ALDR (TP$20, Outperform) - Earnings release likely in the first half of August:
ALDR is not currently an earnings driven story. This will be the company's first quarter
call since the IPO in May 2014. The primary focus of the release will be 1) insights on
the recent six-month data released for ALD403, 2) timing and design of Phase IIb trial
for ALD403 in migraine, and 3) timing of clazakizumab Phase II data in psoriatic
arthritis to be released by Bristol around YE:14.
■ ALXN (TP $174, Neutral) - Pre-open release, call at 10am ET on 7/24. We forecast
Q2 revenues of $511M, in-line with consensus of $510M. We forecast Q2 gross
margins of 92%, R&D of $88M and SG&A of $139M -- our Q1 EPS estimate is $1.08,
just above consensus of $1.07. For full-year 2014, we forecast revenues of $2.19B (vs
consensus of $2.18B) and EPS of $4.90 (vs consensus of $4.87). ALXN has a track
record of raising revenue and EPS guidance with quarterly calls – in Q1, full-year 2014
EPS was raised to $4.75-$4.85 (from $4.37-$4.47), while revenue of $2.15-$2.17B
was maintained. We would look for updates on the progress of the pipeline, including:
progress on the global filings for asfotase alfa (HPP), enrollment progress on the
various new indications for Soliris and any updates on 1007, 1102/1103 and next-gen
Soliris.
■ ATLN (TP Sfr125, Outperform) – Pre Open Release/Call at 8am on 7/22: We
forecast in-line Tracleer revenues of SFr364M (vs. consensus of SFr366M). The more
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important headline number is Opsumit revenues. We forecast in-line Opsumit
revenues of SFr34M vs. Consensus SFr32M. We expect the call to be focused on the
early launch dynamics around Opsumit especially around "real-world" physicians'
views on the morbidity/mortality label. Given recently announced positive PIII
selexipag/GRIPHON data, we anticipate focus on the call to be on further details
surrounding filing/launch dates, launch preparations, and marketing strategy. Given
Tracleer's patent expiration in the US/EU in late 2015/2016, Opsumit and now
Selexipag revenues are expected to help sustain ATLN's long term topline and bottom
line growth which in turn are required to fundamentally justify ATLN.VX's multiple.
■ ARIA (TP$8, Neutral) – Call on August 6 at 8:30am EST: The primary metric for
ARIA is its top-line sales. We forecast US Iclusig sales of $15.9M (up from $8.0M in
Q1) vs consensus of $11.1M. The primary focus will be (1) Iclusig re-launch in the US
(topline number, patients on drug, line of therapy), (2) plans on restarting trials and
additional trials now that partial clinical hold was lifted; (3) plans to move to flat pricing
across doses; (4) progress on EU roll-out, including the Pharmacovigilance Risk
Assessment Committee (PRAC) delay that was recently announced. We forecast Q2
GAAP EPS of ($0.26) and revenue of $16.0M vs. consensus of ($0.29) and $13.7M.
■ ARNA (TP $4, Underperform) – release/call likely in early August; Eisai reports
net sales on August 1. The primary driver continues to be Belviq (for obesity). We
forecast $14M for Q2 Belviq US net sales, below consensus of $16M. IMS data
suggests Q2 could be even lower, with implied demand of around $12M (of which
ARNA would receive a 31.5% royalty, but is resposible for COGS). The exact number
depends in part on what Eisai reports for its ASP and the quarterly fluctuations have
been significant (as well as higher than what is implied by IMS prescription data). End-
user sales are booked by its partner, Eisai, and revenues are recognized on the sell-in
method (at the time of sale to the wholesaler). Revenues have been running higher
than Rx-implied patient demand, suggesting stocking. A television DTC is now
underway, though its effects may have been muted somewhat, with only 400 reps in
the field. In early July, Eisai expanded the field force to 600. Seasonality may be a
headwind in the second half of the year as would be a Contrave (OREX/Takeda)
approval/launch in September, which does not seem to be reflected in current
published sell-side consensus. We are below consensus for the next several quarters
($70M vs $78M for 2014).
■ BIND (TP$20, Outperform) – Call likely in first full week of August: BIND is
currently not an earnings driven story. Investors will be most focused on (1) updates
on the timing of Phase II data for BIND-014 in prostate and lung cancer (outside
chance of announcing data on the call), (2) potential updates on enrollment progress
of the KRAS mutant NSCLC trial and initiation of the multi-cohort trial in a variety of
rarer tumor types, and (3) progress on partner INDs and internal clinical candidates.
Our Q2 GAAP EPS estimate is ($0.64) vs. consensus of ($0.55).
■ BMRN (TP $73, Outperform) – Post-close release. Call at 4:30pm on July 30. We
forecast Q2 revenues of $162M, largely in-line with consensus of around $160M. We
forecast EPS of $(0.41), in-line with consensus $(0.41). This is the first full quarter
since the Vimizim approval earlier this year -- we model $8.7M in revenues for the
quarter. Several data releases are due next year (BMN 111, dwarfism; BMN 190,
Batten disease; PEG-PAL, PKU; BMN-701, Pompe disease) – we think BMRN will
trade higher into these events.
■ CLVS (TP$100, Outperform) – Release/call likely in early August: CLVS is
currently not an earnings-driven story. The spotlight remains on CO-1686 as a
treatment for first-line EGFRm+ and second-line EGFRm-T790M+ NSCLC. PI data
presented at ASCO showed that CO-1686 and AZD9291's efficacy was highly
comparable. Safety was the key focus with the street positioning AZD9291 having a
cleaner safety profile than CO-1686 (hyperglycemia (22% Grade 3) and QTc
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Global Biotechnology 18
prolongation (7% Grade 3)). The call may provide mgnt to expand the IGF1R
hypothesis. We anticipate additional attention on: (1) Updates on Lucitinib PII trials in
advanced breast cancer (FGFR1-amp, 11q-amp, FGF-WT) and squamous NSCLC
(FGFR1-amp); (2) Updates on ARIEL2 PII biomarker trial and ARIEL3 PIII trial both
for Rucaparib in platinum-sensitive, relapsed ovarian cancer.
■ CORT (TP$2, Neutral) – Release/call likely in Early August: The key headline
number is still Korlym Q2 sales. We forecast sales of $5.9M, which is in-line with
consensus ($6.0M). We expect that the focus will be on any commentary about the
ongoing Korlym launch. Other areas of interest include any updates on the PI trial for
Mifeprostone + Halaven in patients with triple negative breast cancer (TNBC) and EU
filing for Korlym in endogenous Cushing's Syndrome.
CBST (TP$77, Outperform) - Call on July 22 at 5:00pm EST: Cubist is primarily a
top-line story, and we forecast $252.1M in US Cubicin sales vs. consensus of
$251.4M. Our analysis of Q2 sales based on IMS and WK estimates predicts a range
of $232M-$243M assuming June sales are 0-5% higher than the April/May average.
This $232M-$243M range is lower than our estimate and the consensus estimate,
suggesting some risk in the quarter. Estimates based on IMS and WK have been
unpredictable over the last several quarters due to a fluctuating capture rate, and this
could impact this quarter as well. Focus of the call is expected to be (1) ongoing
litigation in Hospira dispute (a ruling or settlement is expected any day), (2)
commercial strategy for recently-approved tedizolid, and (3) update on bevenopran
program (opioid-induced constipation) following recent AdCom (Ph III safety data is
expected in Q3:14). We forecast GAAP Q2 EPS of $(0.15) and revenues of $306.3M
vs. consensus of $0.01 and $299.6M.
■ DNDN (TP $2.50, Neutral) – Call likely in August. We model Provenge revenues of
$75M, just above consensus of $74M. We would look for any commentary on early Q3
trends, price/volume mix (there is a stated y/y price tailwind, although the effective
increase is much less) and any commentary on the debt restructuring, although
typically little is said. The debt restructuring remains the most meaningful overhang on
DNDN equity. CEO John Johnson is stepping down in August – this may signal that a
successful restructuring is not on the near-term horizon.
■ DRTX (TP$22, Outperform) – Call likely in the first full week of August: DRTX is
currently not an earnings driven story. The recent FDA approval for Dalvance will likely
shift the focus of the earnings call to launch activities (timing of US launch, feedback
on pricing from the field, etc.) and timing of the EU filing. Durata will likely highlight
progress with additional clinical trials in potential expansion indications, such as
osteomyelitis and its "once and done" trial. We forecast GAAP Q2 EPS of ($0.71) vs.
consensus of ($0.67).
■ ECYT (TP$9, Outperform) – Call likely late July/early August: ECYT is not
currently an earnings driven story. After failure of vintafolide in ovarian cancer and the
termination of the Merck partnership, focus has shifted to the pipeline, particularly
ECYT's proprietary folate-tubulysin drug (EC1456) in Phase I. Any updates on the trial
(initial data expected in H2:14) will be a focus. Another focus is the timing and venue
for presenting the primary PFS and survival data for the TARGET Phase II lung cancer
study, as this data will guide whether or not ECYT pursues the program on its own.
We forecast Q2 GAAP EPS of $0.55 on revenues of $48.2M vs. consensus of $0.13
on revenues of $22.1M. Our revenue estimate includes the non-cash accelerated
recognition of deferred revenue from the discontinued Merck partnership.
■ ENTA (TP$43, Outperform) – Release/call likely in Mid August: ENTA is currently
not an earnings-story. The key asset for ENTA is ABT-450. ABBV announced in
April/May that it had filed an NDA/MAA for the all-oral, interferon-free fixed dose ABT-
450/r-based regimen for GT1 patients. This combination though is less convenient
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Global Biotechnology 19
than GILD's Sofosbuvir/Ledipasvir, generally on treatment duration and pill burden.
We expect that the focus of the call will be on updates regarding pricing strategies to
compete against GILD and minimize payer pushback. We also anticipate some
interest in ENTA's earlier stage pipeline, particularly on ABT-493 and EDP-239. ABT-
493, a second-generation protease inhibitor, has been paired with ABT-530, a second-
generation NS5A inhibitor, in a PII trial. ABT-493 could enable ENTA to obtain more
favorable economics on sales of all-oral, interferon-free regimens for HCV from ABBV.
EDP-239, a NS5A inhibitor partnered with NVS, is currently in a PI trial.
■ ESPR (TP$26, Outperform) – Call likely in first half of August: ESPR is currently
not an earnings driven story. We expect ESPR will likely highlight the ongoing Phase II
studies with ETC-1002 in statin intolerant patients (Study 008) and in residual risk
patients (Study 009). Enrollment completed in both, data expected in Oct 2014 and
YE:14, respectively. Investors will likely focus on (1) the evolving competitive and
regulatory landscape for lipid lowering drugs – specifically the PCSK9 inhibitor class
and potential need for outcomes studies, (2) clinical assumptions for defining success
in Studies 008 and 009, and (3) the status of ongoing preclinical studies (carc study,
etc.) which are important for lifting the partial clinical hold and removing the PPAR
inhibitor classification. Our Q2 GAAP EPS estimate is ($0.58) vs. consensus of
($0.60).
■ EXEL (TP $5, Neutral) – Post-close release, call at 5pm ET on 7/31. We model
$5.5M in Cometriq revenues for Q2, in-line with consensus of $5.6M for its currently
approved medullary thyroid cancer indication, which is a relatively modest setting.
Cometriq also has trials underway in prostate cancer, renal cancer and liver cancer.
The primary focus has been prostate cancer and COMET-1, the overall survival trial
required for approval in that setting (COMET-2 should be viewed as more of a
marketing study). EXEL has announced that COMET-1 missed overall survival at the
single interim analysis (387 events). Final OS (after 578 events) is expected later this
year. We continue to view COMET-1 as seemingly a make-or-break trial and one
that's difficult to predict. Besides COMET-1 and COMET-2, full results from
cobimetinib (melanoma), out-licensed to Roche, will be presented. EXEL and Roche
announced the primary endpoint of PFS has been met, although the category is
becoming increasingly competitive.
■ IMGN (TP$14, Neutral) – Call on August 1st at 8 AM EST: IMGN is not an earnings
driven story. The primary focus for investors will likely be the upcoming data for
proprietary programs IMGN529, IMGN853, and IMGN289. Toxicity issues have been a
key focus lately for these programs. The focus of the call is expected to be (1) plans to
advance the IMGN853 program, (2) status, plan, and toxicity issues with IMGN529,
and (3) timing of first data for IMGN289 (EGFR). Another key focus for investors will
be the ongoing launch and ultimate market potential of Roche’s Kadcyla (royalty to
IMGN), though IMGN is not likely to provide any details not already provided by
Roche. IMGN is expected to report FYQ4:14 royalties of approximately $3.4M based
on the Roche reported Q1:14 sales of CHF102M (~$114M). FYQ3:14 royalties will be
based on Q2:14 sales to be reported by Roche. Partner Sanofi reports earnings on
July 31 at 8:30 AM EST. We may hear some update on plans for the anti-CD38 drug
for myeloma (SAR650984) and potentially its CD19 ADC (SAR3419). Both had data at
the recent ASCO meeting. We forecast FY:Q4 EPS of ($0.32) on revenues of $7.7M
vs. consensus of ($0.32) on revenues of $9.7M.
■ INFI (TP$20, Neutral) – Call likely August 5 before market open: INFI is not
currently an earnings driven story. We expect investors will be most focused on any
updates to enrollment in the ongoing clinical program. This includes updates on
recruitment for DYNAMO (relapsed/refractory NHL) and DUO (head-to-head vs.
ofatumumab in relapsed CLL), and expected initiation of DYNAMO+R (Rituxan vs.
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Global Biotechnology 20
Rituxan+IPI-145 in relapsed iNHL) and new studies in iNHL and in front-line CLL
(+FCR). We forecast Q2 GAAP EPS of ($0.80) vs. consensus of ($0.86).
■ IRWD (TP$16, Outperform) – Post-close release/call at 4:30pm ET on 8/4: The key
number to look at is Linzess end-user US sales. IRWD launched its DTC campaign in
early April. Linzess TRx and NRx scripts have shown a noticeable uptick since DTC
launch and we forecast underlying demand to be $70.2M given IMS reported Q2 TRx
of ~326K (and assuming a net price of $205 per script). Our modeled estimated
Linzess revenue of $71.3M (vs. consensus of $72.0M) assumes only $1.1M of
stocking/inventory. Our low estimate for inventory stocking is driven by expectations of
a reduced pace of stocking by distributors after higher than expected stocking in Q1 in
anticipation of the DTC launch (4-5 weeks inventory at the end of Q1 vs. 2-3 weeks
longer term guidance). We expect focus on the conference call to be on (1) more
granularity on the DTC launch (2) Concomitant changes in cash burn expectations and
requirement for capital (3) Linzess granularity such as marketing mix, sampling rates,
net discounts, and rebates.
■ ITMN (TP$33, Neutral) – Release/call likely in late July: The most important
headline number is Esbriet Q2 sales. We are forecasting Esbriet Q2 sales of $33.3M,
which is in-line with consensus of $34.1M. Focus on the call is likely to be on going
launch preparations for Esbriet in the US expected in Q1'15, with potential for an
earlier launch, given the FDA PDUFA date of November 23, 2014. We expect ongoing
focus on the extent morbidity/mortality outcomes makes it into the final label. Other
areas of interest include commentary regarding treatment dynamics (especially
persistence rates) in Germany, France, UK, Italy, and various mid-sized European
countries in which reimbursement has already been secured as well as any
observable impact on Esbriet use in the EU after the positive ASCEND PIII data
release. Additional attention will likely be on the ongoing reimbursement negotiations
with Spain and granularity on EU relabeling to reflect ASCEND-related data at the end
of 2014.
■ KITE (TP$34, Outperform) – Earnings release likely first half of August: KITE is
not currently an earnings driven story. We expect investors will be most focused on
any updates to KITE's clinical strategy, progress with its new manufacturing process,
and plans for its pipeline candidates. We forecast Q2 GAAP EPS of ($0.65).
■ MDCO (TP$28, Neutral) – Call on July 23 at 8:30am EST: We expect that investors
will be largely focused on (1) plans for refiling Cangrelor following its recent rejection,
(2) generic challengers for Angiomax, and (3) the upcoming PDUFA for oritavancin.
The expectations for oritavancin approval are high given the recent approval of
Dalbavance. We also expect that MDCO will begin to attempt refocus investor
attention on other near term product opportunities, including Fibrocaps and IONSYS,
neither of which the Street gives much credit. WK and IMS Angiomax sales estimates
have been difficult to predict over the last four quarters because of the unusually large
final month. If we assume a final month in line with the average of the last four final
months, Angiomax is tracking in line. For the first two months of Q2, WK sales
estimates are down 1.0% y/y and IMS estimates are down 6.5% y/y. Our Angiomax
estimate is $142.0M (up 2.9% y/y). We forecast Q2 GAAP EPS of $0.04 on revenue of
$186.4M vs. consensus of ($0.02) on revenue of $183.7M.
■ MDVN (TP $95, Outperform) – Release/call post-close August 7th; Astellas
reports Aug 1. For Q2, we forecast $133M in total US net sales (consensus is
$131M), representing just under a 7% sequential increase from Q1. Of this, MDVN
receives 50% ($66.3M). We also forecast $59M in collaboration revenue (milestones
and amortized revenues) and $8M in ex-US (12%) royalties on $63M net sales
(consensus is $59M). For the year, we forecast $562M (guidance: $540-$575M;
consensus is $576M) in US end-user net sales and around $300M in EU/JPN end-
user net sales on which MDVN receives royalties. Current sales are largely relegated
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Global Biotechnology 21
to the post-chemo setting, but full Xtandi pre-chemo (PREVAIL) data were released
earlier this year and the US/EU pre-chemo applications have been filed (the PDUFA
date on the US application is Sept 18th). Key to watch is the ongoing Xtandi
performance (particularly after the disappointing guidance earlier this year – we think
Xtandi will likely beat at least in Q2) and the pre-chemo approval/uptake. Notably,
Xtandi Rx data will eventually be trackable, as Astellas is in the process of removing
channel data reporting prohibitions, although it's been a very gradual process. Beyond
PREVAIL, further catalysts are "TERRAIN" (Xtandi vs Casodex), fully enrolled since
last May, and breast cancer Phase II data - "TERRAIN" could come late this year or
early next year.
■ MVIR (TP SEK115, Outperform) – Release/call on 8/21: The most important asset
for MVIR is Olysio (Simeprevir), a second-generation protease inhibitor, for treatment
of HCV. MVIR's marketing and commercialization partner, JNJ, reported Olysio sales
of $831M in Q2 (US: $725M; Intl: $106M). Assuming a royalty rate of 7.0% and an
exhange rate of SEK6.60/per dollar, we estimate Olysio sales of SEK384M. We
expect focus on the call to be on the ongoing near-term as well as medium-term
launch dynamics associated with Olysio. On other financial metrics, we also forecast
Q2 Biophausia sales of SEK45M. The focal points remains on the ongoing PII trials
involving all-oral, interferon-free regimens containing Simeprevir in 2014.
■ OREX (TP $10, Outperform) – Release/call likely in August: The key asset for the
company is NB32 (formerly Contrave), the combination of bupropion and naltrexone,
for the treatment of obesity, which will be marketed in conjunction with Takeda.
Importantly, Takeda said it will launch NB32 with a sizeable sales force (900 reps vs.
the 150 and 200 that VVUS and Eisai initially put behind Qsymia and Belviq,
respectively). NB32 received a 90-day extension and now has a PDUFA date of
September 11th. The delay apparently relates to the handling of the CVOT post-
approval. OREX is guiding to a potential CHMP recommendation by Q3'14 and EU
approval by year-end. Following the positive interim read of the Light Study CVOT, we
anticipate approval both in the US and EU. There is likely little additional commentary
management can make ahead of this. For 2014, we model $12M in NB32 end-user
product sales. Following the sluggish launches of both VVUS' Qsymia and
Eisai/ARNA's Belviq, and the lack of progress on EU approval for both of those
products, we think the Street's expectations for the NB32 US roll-out and EU
approval/partnering are pretty modest.
■ PCYC (TP$121, Outperform) – Call likely in the at the end of July/early August:
Q2:14 will be the second full quarter of Imbruvica sales, and weekly IMS script data
suggests strong Q2 sales, tracking in a $90M - $102M range, assuming a 79% ± 5%
capture rate (based on last quarter's actuals). Our Imbruvica Q2 estimate is $94.2M vs
the consensus estimate of $75.7M. We expect PCYC will raise its overly conservative
Imbruvica guidance. Investors are most focused on the new guidance, given the
negative reaction to last quarter's conservative guidance. As is typical for PCYC, we
anticipate detailed updates for the entire ibrutinib clinical program. Our Q2 GAAP EPS
estimate is ($0.35) vs. consensus of ($0.26).
■ PTLA (TP$34, Outperform) – Call likely first full week of August: PTLA is not an
earnings driven story. Investors will be most focused on (1) clinical and regulatory
progress on andexanet alfa (potential Phase III readouts in Q4:14), (2) update and
recent data readout on the Lovenox program; (3) plans for a go/no-go decision on the
cerdulatinib program, and (4) the planned futility analysis for betrixaban (early 2015).
Our Q2 GAAP EPS estimate is ($0.77) vs. consensus of ($0.79).
■ PRTA (TP$53, Outperform) – Earnings release likely August 4th
or 5th
(no call
expected): PRTA is not an earnings driven story. Investors will be most focused on
the next data release for the NEOD001 program in AL amyloidosis, particularly data
on longer-term follow-up. For the call, investors will focus on: (1) the clinical/ regulatory
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Global Biotechnology 22
plan and FDA discussions for the NEOD001 program, (2) insight into ongoing Phase I
for PRX002 with Roche, and (3) initiation timing of the PRX003 trial. Our Q2 GAAP
EPS estimate is ($0.06) vs. consensus of ($0.14).
■ PTCT (TP$35, Outperform) – Call likely August 7 before market open: PTCT is not
an earnings driven story. After an initial rejection, PTCT gained CHMP
recommendation for approval of Translarna in Europe on re-examination, a better than
anticipated outcome. Investors are now focusing on (1) the EU launch plan and rollout,
(2) potential early DMD filing in the US (could be in Q4:14), (3) potential early filing for
CF in Europe (potentially H1:15), (4) progress in the Phase III DMD trial (data
expected in Q3:15), (5) updates on the recently initiated confirmatory Phase III in
cystic fibrosis, and (6) any update on the ongoing Phase I trial for the SMA program.
Our Q2 GAAP EPS estimate is ($0.72) vs. consensus of ($0.74).
■ RCPT (TP$58, Outperform) – Release/call likely in Early August: RCPT is
currently not an earnings-driven story. RCPT announced positive topline RADIANCE
PII data readout in June'14 with additional granularity expected to be presented at
ACTRIMS-ECTRIMS in Boston, September 10-13th. RPC1063 could be a significant
winner in the multiple sclerosis “revolution”. We believe that RPC1063’s clinical profile
– notably shorter half-life, faster recovery of lymphocytes, as well as improved cardio-
and hepato-toxicity safety – could provide RPC1063 with a competitive advantage
over Gilenya. Additional focus will likely be on updates on the going PII trial for
RPC1063 in ulcerative colitis (topline TOUCHSTONE PII data due Q4'14) and the PII
trial for RPC4046 in eosinophilic esophagitis.
■ REGN (TP$340, Outperform) – Call likely early late July / early August: Investors
will be primarily interested in US and ex-US Eylea sales. Any new information on
Avastin compounding and market share dynamics will be a focus. Our US sales
forecast is $391.9M vs. Consensus of $416.3M (ThomsonOne). Eylea ex-US
commercial partners Bayer and Santen report on July 30 and August 4, respectively.
Partner Sanofi reports Q1 earnings on July 31 at 8:30 AM EST, and could provide
some update to their shared pipeline programs. On the Q2 call, we expect investors
will focus on (1) current and future market dynamics in AMD and DME, (2) ongoing
clinical data and regulatory plan for alirocumab (PCSK9), (3) clinical plan for
dupilumab in asthma and atopic dermatitis, and (4) the expanding pipeline programs.
We forecast Q2 GAAP EPS of $0.79 on revenue of $616.3M vs. consensus of $0.89
on revenue of $644.6M (ThomsonOne).
■ SCMP (TP$8, Neutral) – Release/call likely in Early August: For Q2, our estimates
are essentially in-line with consensus for total revenues ($23.8M vs. $24.1M) and
above consensus on EPS ($0.04 vs. $0.02). We expect the primary focus of the call to
be on updates regarding the alternate formulation of liquid lubiprostone as well as
updates on topline PIb ion-channel activator for LSS expected in Q4'14.
■ SGEN (TP$51, Outperform) - Call at 4:30 pm EST on July 31: We forecast US
Adcetris sales of $40.7M vs consensus of $46.3M (excluding one outlier, consensus is
$41.2M), While an in-line or better quarterly Adcetris sales number is important for
continued outperformance, investor focus is largely dependent on upcoming clinical
data for Adcetris, including Phase 3 AETHERA data (post-transplant setting) in H2:14,
and the pipeline. We expect investors to focus on the following updates during the Q2
call (1) plans for modifying endpoints in the Adcetris frontline trials (ECHELON 1 and
ECHELON 2), (2) upcoming AETHERA data and potential expanded use in that
indication, and (3) upcoming data presentations including SGN-33a for AML. We
forecast Q2 EPS of $(0.18) on revenue of $69.0M vs. consensus of $(0.22) on
revenue of $65.0 M.
■ SGYP (TP$9.20, Outperform) – Release/call likely in Early August: SGYP is
currently not an earnings-driven story. The key asset for SGYP is Plecanatide. Focus
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Global Biotechnology 23
will likely be on updates regarding the PIII trial in CIC (topline data in Q2'15).
Competitor Linzess's launch progress is important as this drug is seen as building the
market for Plecanatide, which uses the same mechanism of action and targets the
same indications. Discussion on potential partnerships will be important as SGYP
currently has 100% economics. Management has made clear that their end goal is to
be acquired by a larger pharmaceutical company.
■ SNSS (TP$6, Neutral) – Call likely on August 5: SNSS is not an earnings driven
story, and we do not expect any major update on the call. SNSS completed enrollment
in the Phase III VALOR trial at the end of September, 2013, and is guiding to a data
release in Q3 or Q4:14. The readout has been pushed back a few times due to a lower
than anticipated event rate; any insight on timing will be the focus. Our Q2 GAAP EPS
estimate is ($0.17) vs. consensus of ($0.17).
■ UTHR (TP$75, Neutral): Release Call likely in Late July: For Q2, we are forecasting
in line total revenues ($315M vs. $308M for consensus) and GAAP EPS ($1.57 vs.
$1.62 for consensus). We project Remodulin sales of $136M (vs. $133M for
consensus) and Tyvaso sales of $125M (vs. $121M for consensus). UTHR launched
Oral Remodulin/Orenitram in May'14. Investor attention is likely to be focused on any
commentary on the initial launch and expected ramp for Orenitram in the US and
remodulin in Japan. Additional focus will be on any updates on litigation between
UTHR and Sandoz in response to Sandoz filing an ANDA against Remodulin (trial
expected to begin in mid-2014). The 30 month stay will expire in Aug-2014 potentially
allowing for generic competition to Remodulin as early as September. Investors will
also keenly watch for any updates on the launch of the Synchromed II (implantable)
"pump" expected in 2015/2016.
■ VICL (TP $1.50, Neutral) – Release/call likely July/August. Following the
termination of Allovectin, the focus turns to ASP0113, a vaccine partnered with
Astellas. It’s now generally quiet - upcoming catalysts are Phase II results from the
ASP0113 SOT trial as well as potentially a progress update of some sort from the first
100 patients of the Phase III ASP0113 HCT trial, but these updates would seem to be
relatively minor catalysts (the final Phase III HCT data is still a few years away).
■ VRTX (TP$94, Neutral) – Pre-open release/call at 9:00am ET on 7/23: For Q2
earnings, we are below consensus on total revenues (CS: $111.7M vs. Consensus:
$128.6M) and EPS (CS: ($0.92) vs. Consensus: ($0.74)). We forecast slightly below
consensus Kalydeco sales (CS: $111.7M vs. Consensus: $117.7M). Given the recent
positive PIII TRAFFIC/TRSNPORT data, we expect that investors will be paying more
attention to filing updates (expected in Q4'14) and launch timelines. Any additional
granularity on the PIII data is expected to be presented at NACFC from 9th-11
th
October, 2014. We expect further focus on any updates on VRTX's triple combination
for Homozygous and Heterozygous F508del CF. Additional focus could include
dynamics of the ongoing Kalydeco launch, updates on partnership discussions for VX-
509 for RA, and further details on VRTX's earlier stage assets in oncology and
multiple sclerosis.
■ VVUS (TP $6, Neutral) – Release/call likely in August: The launch of VVUS’
Qsymia is ongoing. When the anti-obesity agent was approved, the product was
saddled with a restrictive REMS that limited distribution to mail order. The REMS was
relaxed in April 2013 and VVUS began launching Qsymia into the normal retail
distribution channels last July. Over the past couple of months, prescription growth
has stalled, likely due to rebates being curtailed, the sales force being restructured
and Eisai expanding its sales force (the latter suggests Takeda's expected Contrave
launch in September could impact both Qsymia and Belviq performance further
following the expected September launch). For Q2 we are below consensus on
revenues: $15.7M vs $17.7M. Expanding the sales force or finding a partner are now
18 July 2014
Global Biotechnology 24
past-due. It's difficult to see what could take the stock higher short of a partnership at
this point, but any deal would require relinqiushing meaningful economics.
■ XNCR (TP$14, Outperform) – Call likely in first half of August: XNCR is currently
not an earnings driven story. The focus will be on the progress of the proprietary early
stage pipeline, including (1) timing and expectations for XmAb7195 Phase I data,
expected H1:15, (2) timing of readout for XmAb5871 Phase IIa trial in RA, expected in
Q4:14, and (3) announcement of a lead bispecific program, potentially multiple
myeloma (CD38xCD3) or acute myeloid leukemia (CD123xCD3), including timing of
preclinical data presentation and IND filing. Our Q2 GAAP EPS estimate is ($0.19) vs.
consensus of ($0.19).
■ XNPT (TP$7, Outperform) – Release/Call likely in Early August: For Q2, we are
forecasting Horizant sales of $3.6M, which is in line with consensus of $4.4M. Investor
attention is likely to focus on XP'829. XP'829 entered PII trials in moderate to severe
psoriasis in Q2'14. Recall, the PII trial will evaluate QD and BID at doses that produce
daily MMF exposures similar to that of BIIB's Tecfidera as well as QD at a lower dose.
Topline data is still expected 12-14 months afterwards (Mid'15). XNPT currently has
enough cash at hand to fund operations through 2015 to the readout of the PII trials
for XP'829.
■ XOMA (TP$8, Outperform) – Call likely in August 7 after the close: XOMA is
currently not an earnings driven story. On the Q2 call, we expect investors will focus
on (1) timeline refinement for the Phase III EYEGUARD B readout of gevokizumab in
Behcet's uveitis (previously guided to hitting the number of events required by end of
June, but has pushed back due to a slower rate of summer exacerbations), (2)
updates on enrollment for EYEGUARD A and C trials, and (3) regulatory plans for
gevokizumab in pyroderma gangrenosum. Our Q2 EPS estimate is ($0.19) vs.
consensus of ($0.21).
18 July 2014
Global Biotechnology 25
Exhibit 17: Comprehensive Calendar of Events in July (Earnings – Black/Blue, PDUFA – Green, Conferences/Analyst
Days – Red, Annual General/Shareholder Meetings - Purple)
Monday Tuesday Wednesday Thursday Friday
Ticker
Time / Telephone
(PIN)
14 15 16 17 18
21 22 23 24 25
Actelion
08:00/866.305.6290
Cubist
17:00/855.139.7654
(Psw: 55596186)
Biogen Idec
9:00/877.650.1145
(Psw:70022353)
GlaxoSmithKline
9:00/TBA
The Medicines Company
8:30/877.359.9508
(Psw: 68208610)
Gilead Sciences
16:30/877.359.9508
Illumina
17:00/888-679-8034
(60693837)
Lonza
1:30, 8:30/631.570.5613
(Psw: 0516363)
BristolMeyrsSquibbs
10:30/ 913.312.6681
(Psw: 3903092)
Celgene
9:00/TBA
Eli Lilly
09:00/TBA
Alexion
10:00/800.967.7137
(Psw: 3903092)
Roche
07:00/631-570-5613
AACC - The American
Association for Clinical
Chemistry - Annual Meeting
- July 27 - 31, Chicago, IL
ACRX (Zalviso) PDUFA - July
27
28 29 30 31
Almirall SA
4:00/+44.20.3427.1901
(Psw: 5071598)
Merck
8:00/877.381.5782
(Psw: 62998996)
Pfizer
10:00/866.246.2545
(Psw: Second Quarter
Earnings)
Vertex
17:00/866-501-1537
Amgen
17:00/706.679.5823
(59061932)
BMO Capital Markets
Biotech Corporate Access
Day, Boston, MA
ANCR (Tavabrole) PDUFA
Biomarin Pharmaceuticals
16:30/877.303.6313
(Psw: 59207209)
Bayer
08:00/855-272-3513
Shire Plc
TBA
UCB
TBA
Exelixis
17:00/800.706.7745
Seattle Genetics
16:30/800.839.7875
(Psw: 7088135)
Astrazeneca
07:00/866-977-7645
(29614047)
Sanofi
08:30/866-907-5928
BMO Capital Markets
Biotech Corporate Access
Day - San Francisco, CA
July
Estimated 28th - 31st July: Allergan, Vical, Pharmacyclics, Forest, Abbvie, Intermune, United Therapeutics Source: Company data, Credit Suisse estimates
18 July 2014
Global Biotechnology 26
Exhibit 18: Comprehensive Calendar of Events in August (Earnings – Black/Blue, PDUFA – Green, Conferences/Analyst
Days – Red, Annual General/Shareholder Meetings - Purple)
Monday Tuesday Wednesday Thursday Friday
1
Ticker
Time / Telephone
(PIN)
Immunogen
08:00/TBA
4 5 6 7 8
Ironwood
16:30/877.643.7155
(Psw: 67488246)
Infinity
TBA
Sunesis
TBA
Ariad
08:30/888.771.4371
(37600188)
MDCO (Oritavancin) PDUFA
GILD (Idelalisib) PDUFA
Lundbeck
TBA
Novo Nordisk A/S
TBA
Medivation
TBA
PTC Therapeutics
TBA
XOMA
TBA
SPPI (Beleodaq) PDUFA -
August 09
11 12 13 14 15
Wedbush Life Sciences
Management Access
Conference - August 12 - 13,
New York, NY
Meda
16:30/TBA
Canaccord Genuity Annual
Growth Conference -
August 13 -14, Boston, MA
Piper Jaffray Heartland
Summit - August 14 - 15,
Minneapolis, MN
18 19 20 21 22
REGN (Eylea) PDUFA
Medivir AB
TBA
BIIB (Plegridy) PDUFA
25 26 27 28 29
PFE/BMY (Eliquis) PDUFAIspen SA
TBA
August
Estimated 11th - 15th August: Ambit Biosciences, Myriad Genetics, Enanta, Ultragenyx, Esperion, Xencor
Estimated 18th - 22nd August:
Estimated 25th - 29th August:
Estimated 04th - 08th August: Bind, Prothena, Clovis, Endocyte, Synergy, Dendreon, Vivus, Synageva, Corcept, Orexigen, Durata, XenoPort,
Sucampo, Regeneron, Idenix, Achillion, Akebia, Arena, Achaogen, Kite, Portola, Receptos
Source: Company data, Credit Suisse estimates
18 July 2014
Global Biotechnology 27
Companies Mentioned (Price as of 17-Jul-2014)
Achaogen (AKAO.OQ, $11.05) Achillion Pharmaceuticals Inc. (ACHN.OQ, $6.65) Actelion (ATLN.VX, SFr109.2) Akebia (AKBA.OQ, $23.49) Alexion Pharmaceuticals Inc. (ALXN.OQ, $155.06) Amgen Inc. (AMGN.OQ, $115.39, NEUTRAL, TP $125.0) Arena Pharmaceuticals Inc (ARNA.OQ, $4.81) Ariad Pharmaceuticals, Inc. (ARIA.OQ, $5.0) BIND Therapeutics (BIND.OQ, $9.3) BioMarin Pharmaceutical, Inc. (BMRN.OQ, $55.78) Biogen Idec (BIIB.OQ, $299.29, OUTPERFORM, TP $400.0) Celgene Corp. (CELG.OQ, $83.13, OUTPERFORM, TP $112.5) Clovis Oncology, Inc. (CLVS.OQ, $36.44) Corcept Therapeutics (CORT.OQ, $2.33) Cubist Pharmaceuticals (CBST.OQ, $63.24) Dendreon Corp. (DNDN.OQ, $2.05) Durata Therapeutics (DRTX.OQ, $14.59) Enanta Pharmaceuticals (ENTA.OQ, $37.88, OUTPERFORM, TP $43.0) Endocyte, Inc. (ECYT.OQ, $6.14) Esperion Therapeutics (ESPR.OQ, $14.01) Exelixis (EXEL.OQ, $3.43) Gilead Sciences Inc. (GILD.OQ, $85.07) ImmunoGen, Inc. (IMGN.OQ, $10.79) Infinity Pharmaceuticals, Inc. (INFI.OQ, $9.54) InterMune, Inc. (ITMN.OQ, $40.59) Ironwood Pharmaceuticals, Inc. (IRWD.OQ, $13.33) Medivation (MDVN.OQ, $69.58) Medivir SE (MVIRb.ST, Skr129.75) Orexigen Therapeutics Inc. (OREX.OQ, $5.05) PTC Therapeutics, Inc (PTCT.OQ, $23.19) Pharmacyclics, Inc. (PCYC.OQ, $91.5) Portola Pharmaceuticals (PTLA.OQ, $23.96) Prothena Corp (PRTA.OQ, $17.26) Receptos (RCPT.OQ, $34.49) Regeneron Pharmaceutical (REGN.OQ, $296.41) Seattle Genetics (SGEN.OQ, $33.75) Sucampo Pharmaceuticals (SCMP.OQ, $6.11, NEUTRAL[V], TP $8.0) Sunesis Pharmaceuticals (SNSS.OQ, $5.55) Synergy Pharmaceuticals (SGYP.OQ, $3.64) The Medicines Company (MDCO.OQ, $25.59) United Therapeutics Corp (UTHR.OQ, $89.74) VIVUS, Inc. (VVUS.OQ, $4.6) Vertex Pharmaceuticals Inc. (VRTX.OQ, $94.49) Vical Inc. (VICL.OQ, $1.25) XOMA Corporation (XOMA.OQ, $3.7) Xencor, Inc (XNCR.OQ, $9.85) XenoPort (XNPT.OQ, $4.27)
Disclosure Appendix
Important Global Disclosures
Ravi Mehrotra PhD, Jason Kantor, PhD and Lee Kalowski each certify, with respect to the companies or securities that the individual analyzes, that (1) the views expressed in this report accurately reflect his or her personal views about all of the subject companies and securities and (2) no part of his or her compensation was, is or will be directly or indirectly related to the specific recommendations or views expressed in this report.
18 July 2014
Global Biotechnology 28
3-Year Price and Rating History for Amgen Inc. (AMGN.OQ)
AMGN.OQ Closing Price Target Price
Date (US$) (US$) Rating
01-Aug-11 53.77 59.00 N
07-Nov-11 58.43 R
08-Dec-11 58.41 59.00 N
09-Dec-11 58.59 71.00
25-Jul-12 77.96 85.00 O
26-Jul-12 79.30 90.00
03-Jan-13 88.59 100.00
22-Jan-13 83.29 90.00 N
04-Mar-13 92.73 100.00
04-Apr-13 105.90 115.00
17-May-13 105.63 120.00
10-Dec-13 114.10 125.00
* Asterisk signifies initiation or assumption of coverage.
N EU T RA L
REST RICT ED
O U T PERFO RM
3-Year Price and Rating History for Biogen Idec (BIIB.OQ)
BIIB.OQ Closing Price Target Price
Date (US$) (US$) Rating
22-Sep-11 94.54 126.00 O
08-Feb-12 119.60 150.00
12-Sep-12 152.26 165.00
08-Oct-12 151.22 175.00
08-Feb-13 164.44 185.00
04-Mar-13 169.96 200.00
04-Apr-13 195.68 225.00
17-May-13 226.85 255.00
02-Oct-13 246.23 290.00
10-Dec-13 285.23 375.00
13-Feb-14 328.62 400.00
* Asterisk signifies initiation or assumption of coverage.
O U T PERFO RM
3-Year Price and Rating History for Celgene Corp. (CELG.OQ)
CELG.OQ Closing Price Target Price
Date (US$) (US$) Rating
29-Jul-11 29.65 31.00 N
19-Jan-12 36.10 37.50
12-Nov-12 37.83 40.00
03-Jan-13 40.86 42.50
04-Mar-13 52.78 55.00
04-Apr-13 57.98 62.50
17-May-13 62.46 67.50
24-Oct-13 78.98 82.50
10-Dec-13 85.38 105.00 O
18-Jun-14 80.54 112.50
* Asterisk signifies initiation or assumption of coverage.
N EU T RA L
O U T PERFO RM
18 July 2014
Global Biotechnology 29
3-Year Price and Rating History for Enanta Pharmaceuticals (ENTA.OQ)
ENTA.OQ Closing Price Target Price
Date (US$) (US$) Rating
15-Apr-13 20.35 29.00 O *
10-Dec-13 38.14 36.00
09-Feb-14 36.61 43.00
* Asterisk signifies initiation or assumption of coverage.
O U T PERFO RM
3-Year Price and Rating History for Sucampo Pharmaceuticals (SCMP.OQ)
SCMP.OQ Closing Price Target Price
Date (US$) (US$) Rating
21-Jun-13 6.78 8.00 N *
* Asterisk signifies initiation or assumption of coverage.
N EU T RA L
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:
Outperform (O) : The stock’s total return is expected to outperform the relevant benchmark*over the next 12 months.
Neutral (N) : The stock’s total return is expected to be in line with the relevant benchmark* over the next 12 months.
Underperform (U) : The stock’s total return is expected to underperform 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 return relative to the analyst's coverage universe which consists of all companies covered by the analyst within the relevant sector, with Outperforms representing the most attractive, Neutrals the less attractive, and Underperforms the least attractive investment opportunities. As of 2nd October 2012, U.S. and Canadian as well as European ra tings are based on a stock’s total return relative to the analyst's coverage universe which consists of all companies covered by the analyst within the relevant sector, with Outperforms representing the most attractive, Neutrals the less attractive, and Underperforms the least at tractive investment opportunities. For Latin American and non-Japan Asia stocks, ratings are based on a stock’s total return relative to the average total return of the relevant country or regional benchmark; 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 attractivene ss of a stock’s total return potential within an analyst’s coverage universe. For Australian 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 st ock’s total return relative to the average total return of the relevant country or regional benchmark.
Restricted (R) : In certain circumstances, Credit Suisse policy and/or applicable law and regulations preclude certain types of communications, including an investment recommendation, during the course of Credit Suisse's engagement in an investment banking transaction and in certain other circumstances.
Volatility Indicator [V] : A stock is defined as volatile if the stock price has moved up or down by 20% or more in a month in at least 8 of the 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 and/or valuation of the sector* relative to the group’s historic fundamentals and/or valuation:
Overweight : The analyst’s expectation for the sector’s fundamentals and/or valuation is favorable over the next 12 months.
Market Weight : The analyst’s expectation for the sector’s fundamentals and/or valuation is neutral over the next 12 months.
Underweight : The analyst’s expectation for the sector’s fundamentals and/or valuation is cautious over the next 12 months.
18 July 2014
Global Biotechnology 30
*An analyst’s coverage sector consists of all companies covered by the analyst within the relevant sector. An analyst may cov er multiple sectors.
Credit Suisse's distribution of stock ratings (and banking clients) is:
Global Ratings Distribution
Rating Versus universe (%) Of which banking clients (%)
Outperform/Buy* 45% (54% banking clients)
Neutral/Hold* 40% (50% banking clients)
Underperform/Sell* 13% (47% banking clients)
Restricted 3%
*For purposes of the NYSE and NASD ratings distribution disclosure requirements, our stock ratings of Outperform, Neutral, an d Underperform 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 holdin gs, and other individual factors.
Credit Suisse’s policy is to update research reports as it deems appropriate, based on developments with the subject company, the sector or the market that may have a material impact on the research views or opinions stated herein.
Credit Suisse's policy is only to publish investment research that is impartial, independent, clear, fair and not misleading. For more detail please refer to Credit Suisse's Policies for Managing Conflicts of Interest in connection with Investment Research: http://www.csfb.com/research and analytics/disclaimer/managing_conflicts_disclaimer.html
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 cannot be used, by any taxpayer for the purposes of avoiding any penalties.
Price Target: (12 months) for Amgen Inc. (AMGN.OQ)
Method: Our $125 target price for AMGN implies about 14.9x our 2015 ex-option EPS estimate of $8.39, representing about a 2% premium to the S&P 500 2015 PE multiple. This multiple for AMGN is justified due to its <10% growth to 2017 and lower visibility in growth post 2017.
Risk: We see several risks to AMGN's achievement of our $125 target price. (1) More or less biosimilar competition relative to our model. (2) Denosumab could exceed or miss our expectations. (3) Erythropoietin safety concerns could be more or less than our model. (4) Pipeline exceeds expectations. (5) Share buyback could be less aggressive than our model.
Price Target: (12 months) for Biogen Idec (BIIB.OQ)
Method: Our $400 target price for BIIB is about 28x our 2015 option-adjusted EPS estimate of $14.06. This multiple for BIIB is justified due to its >15% growth in 2017, minimal patent risk through 2020, and significant pipeline potential.
Risk: We see several risks to BIIB's achievement of our $400 target price. (1) Tecfidera peak sales could be below our estimates. 2) Avonex share losses are more than expected, slowing down revenue growth. 3) Tysabri net patient additions accelerate less than expected. 4) Significant portion of the mid-stage pipeline fails. 5) BIIB's share buyback program could be less aggressive than expected. 6) Sales of the Hemophilia franchise could be below our estimates.
Price Target: (12 months) for Celgene Corp. (CELG.OQ)
Method: Our $225 target price for CELG is about 23.2x our option-adjusted 2015 EPS estimate of $9.71, representing about a 40% premium to the S&P 500 PE multiple. This multiple for CELG is justified due to >20% growth to 2017.
Risk: We see several risks to CELG's achievement of our $225 target price. (1) Revlimid could face a further delay in Europe. (2) Increases in treatment duration and penetration in the first-line setting for multiple myeloma could be lower than our expectations. (3) Otezla, Pomalyst, and other marketed products could underperform our current estimates. (4) Pipeline failures.
Price Target: (12 months) for Enanta Pharmaceuticals (ENTA.OQ)
Method: Our DCF-derived TP of $43 is based on annual cash flows through 2025 10% discount rate, and no terminal value. The cash flows are based on royalties on the protease inhibitor portion of the sales for protease inhibitor based regimens and add-back of all R&D expenses not associated with ABT-450.
Risk: The risks to our TP of $43 are: (1) The protease inhibitor based regimens are not approved or significantly delayed; (2) The protease inhibitor based reigmens do not demonstrate efficacy and safety expected from studies to date; (3) The protease inhibitor based regimens could underperform our expectations for the product launch ramp or peak sales; (4) Competition is more acute than we model; (5) HCV market may not become as large as expected.
18 July 2014
Global Biotechnology 31
Price Target: (12 months) for Sucampo Pharmaceuticals (SCMP.OQ)
Method: Our DCF-derived target price of $8 is based on cashflows of Amitiza and Rescula, and do not include pipeline assets: SPI-8811 and SPI-017. Additional regional partnerships or approved indications will represent upside from our estimates. We use a standard 10% discount rate on cashflows and add back net cash.
Risk: Risks to our $8 PT include: (1) Better then expected launch of Amitiza in EU and Japan (2) Invalidation of patents in current patent challenge (3) Better than expected uptake of Linzess or competitor products (4) Loss of market share to competitors (5) Poor Amitiza uptake in ex-US launches
Please refer to the firm's disclosure website at https://rave.credit-suisse.com/disclosures for the definitions of abbreviations typically used in the target price method and risk sections.
See the Companies Mentioned section for full company names
The subject company (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, DRTX.OQ, BMRN.OQ, ECYT.OQ, ITMN.OQ, AKAO.OQ, IMGN.OQ, BIND.OQ, OREX.OQ, IRWD.OQ, CLVS.OQ, ATLN.VX, CORT.OQ, AKBA.OQ, GILD.OQ, ESPR.OQ, SGYP.OQ, PTLA.OQ, XNPT.OQ, SGEN.OQ, PTCT.OQ, RCPT.OQ, SNSS.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, XNCR.OQ) 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 (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, DRTX.OQ, ECYT.OQ, AKAO.OQ, BIND.OQ, OREX.OQ, CLVS.OQ, AKBA.OQ, ESPR.OQ, SGYP.OQ, PTLA.OQ, XNPT.OQ, PTCT.OQ, RCPT.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, XNCR.OQ) within the past 12 months.
Credit Suisse provided non-investment banking services to the subject company (AMGN.OQ, BIIB.OQ, CELG.OQ, IMGN.OQ, ATLN.VX, GILD.OQ, REGN.OQ) within the past 12 months
Credit Suisse has managed or co-managed a public offering of securities for the subject company (AMGN.OQ, CELG.OQ, ECYT.OQ, AKAO.OQ, BIND.OQ, OREX.OQ, AKBA.OQ, PTLA.OQ, XNPT.OQ, PTCT.OQ, RCPT.OQ, PRTA.OQ, XOMA.OQ, XNCR.OQ) within the past 12 months.
Credit Suisse has received investment banking related compensation from the subject company (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, DRTX.OQ, ECYT.OQ, AKAO.OQ, BIND.OQ, OREX.OQ, CLVS.OQ, AKBA.OQ, ESPR.OQ, SGYP.OQ, PTLA.OQ, XNPT.OQ, PTCT.OQ, RCPT.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, XNCR.OQ) within the past 12 months
Credit Suisse expects to receive or intends to seek investment banking related compensation from the subject company (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, DRTX.OQ, BMRN.OQ, MDVN.OQ, ECYT.OQ, ITMN.OQ, AKAO.OQ, IMGN.OQ, BIND.OQ, OREX.OQ, CBST.OQ, IRWD.OQ, CLVS.OQ, ACHN.OQ, DNDN.OQ, ALXN.OQ, ARIA.OQ, CORT.OQ, AKBA.OQ, GILD.OQ, ESPR.OQ, SGYP.OQ, VRTX.OQ, PTLA.OQ, VVUS.OQ, XNPT.OQ, MDCO.OQ, SGEN.OQ, PTCT.OQ, RCPT.OQ, SNSS.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, XNCR.OQ) within the next 3 months.
Credit Suisse has received compensation for products and services other than investment banking services from the subject company (AMGN.OQ, BIIB.OQ, CELG.OQ, IMGN.OQ, ATLN.VX, GILD.OQ, REGN.OQ) within the past 12 months
As of the date of this report, Credit Suisse makes a market in the following subject companies (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, SCMP.OQ, DRTX.OQ, BMRN.OQ, MDVN.OQ, ECYT.OQ, ARNA.OQ, ITMN.OQ, AKAO.OQ, IMGN.OQ, BIND.OQ, OREX.OQ, CBST.OQ, IRWD.OQ, CLVS.OQ, ACHN.OQ, DNDN.OQ, ALXN.OQ, ARIA.OQ, CORT.OQ, AKBA.OQ, EXEL.OQ, GILD.OQ, INFI.OQ, ESPR.OQ, SGYP.OQ, VRTX.OQ, PCYC.OQ, PTLA.OQ, UTHR.OQ, VVUS.OQ, XNPT.OQ, MDCO.OQ, SGEN.OQ, RCPT.OQ, SNSS.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, VICL.OQ, XNCR.OQ).
As of the end of the preceding month, Credit Suisse beneficially own 1% or more of a class of common equity securities of (BMRN.OQ, ATLN.VX, VVUS.OQ, PTCT.OQ).
Credit Suisse has a material conflict of interest with the subject company (CLVS.OQ) . Clovis Oncology is a development-stage biotechnology company focused on developing drugs and associated diagnostics for treatment of various cancers.
For other important disclosures concerning companies featured in this report, including price charts, please visit the website at https://rave.credit-suisse.com/disclosures or call +1 (877) 291-2683.
Important Regional Disclosures
Singapore recipients should contact 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 (AMGN.OQ, BIIB.OQ, CELG.OQ, ENTA.OQ, SCMP.OQ, DRTX.OQ, BMRN.OQ, MDVN.OQ, ECYT.OQ, ARNA.OQ, ITMN.OQ, AKAO.OQ, IMGN.OQ, BIND.OQ, OREX.OQ, MVIRb.ST, CBST.OQ, IRWD.OQ, CLVS.OQ, ACHN.OQ, DNDN.OQ, ALXN.OQ, ATLN.VX, ARIA.OQ, CORT.OQ, AKBA.OQ, EXEL.OQ, GILD.OQ, INFI.OQ, ESPR.OQ, SGYP.OQ, VRTX.OQ, PCYC.OQ, PTLA.OQ, UTHR.OQ, VVUS.OQ, XNPT.OQ, MDCO.OQ, SGEN.OQ, PTCT.OQ, RCPT.OQ, SNSS.OQ, PRTA.OQ, REGN.OQ, XOMA.OQ, VICL.OQ, XNCR.OQ) within the past 12 months
Restrictions on certain Canadian securities are indicated by the following abbreviations: NVS--Non-Voting shares; RVS--Restricted Voting Shares; SVS--Subordinate Voting Shares.
Individuals receiving this report from a Canadian investment dealer that is not affiliated with Credit Suisse should be advised that this report may not contain regulatory disclosures the non-affiliated Canadian investment dealer would be required to make if this were its own report.
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Global Biotechnology 32
For Credit Suisse Securities (Canada), Inc.'s policies and procedures regarding the dissemination of equity research, please visit http://www.csfb.com/legal_terms/canada_research_policy.shtml.
The following disclosed European company/ies have estimates that comply with IFRS: (ATLN.VX).
Credit Suisse has acted as lead manager or syndicate member in a public offering of securities for the subject company (AMGN.OQ, CELG.OQ, ENTA.OQ, DRTX.OQ, MDVN.OQ, ECYT.OQ, AKAO.OQ, BIND.OQ, OREX.OQ, CLVS.OQ, ATLN.VX, CORT.OQ, AKBA.OQ, EXEL.OQ, ESPR.OQ, SGYP.OQ, PTLA.OQ, XNPT.OQ, PTCT.OQ, RCPT.OQ, PRTA.OQ, XOMA.OQ, VICL.OQ, XNCR.OQ) within the past 3 years.
As of the date of this report, Credit Suisse acts as a market maker or liquidity provider in the equities securities that are the subject of this report.
Principal is not guaranteed in the case of equities because equity prices are variable.
Commission is the commission rate or the amount agreed with a customer when setting up an account or at any time after that.
For Credit Suisse disclosure information on other companies mentioned in this report, please visit the website at https://rave.credit-suisse.com/disclosures or call +1 (877) 291-2683.
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