Profitable Biotech (Mature Biotech) and non-Profitable Biotech companies (Rising stars) have developed innovative drugs for treatment of chronic and non chronic diseases. In the next five years the distinction between mature biotech companies and large global pharma is likely to disappear as investment in R&D and acquisition start delivering and Market Cap match the large global pharma.
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Profitable Biotech (Mature Biotech) and non-Profitable Biotech
companies (Rising stars) have developed innovative drugs for
treatment of chronic and non chronic diseases. In the next five
years the distinction between mature biotech companies and
large global pharma is likely to disappear as investment in R&D
and acquisition start delivering and Market Cap match the large
global pharma.
3. Brief SummaryBrief Summary
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Profitable Biotech (Mature Biotech) and non-Profitable Biotech
companies (Rising stars) have developed innovative drugs for
treatment of chronic and non chronic diseases. In the next five
years the distinction between mature biotech companies and
large global pharma is likely to disappear as investment in R&D
and acquisition start delivering and Market Cap match the large
global pharma. Dividend and consolidation could be the future
drivers and continue to attract long term investors. Optimism
prevails around the future of this sector as a whole which was
reflected in the unprecedented rally in shares in 2012. We expect
this trend to continue in the next five year driven by launch of
Innovative drugs catering to unmet needs in Alzheimer's, HCV,
osteoporosis, RA, Psoriasis, MS, Dyslipidemia, Cystic fibrosis,
Cancer and orphan diseases. Drug approvals and label expansion
of existing portfolio of launched drugs and data from late stage
pipeline drugs should maintain the growth momentum and
investors interest.
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2012 was recovering from the big acquisitions made in the last
five years by this sector but we expect exercising of some restrain
for similar large acquisitions as investors would like to see the
returns reflected in the top-line and EPS. However in- licensing of
early or mid stage compounds or small acquisitions will continue
since the Rising Stars will keep throwing the bait by taking risks
and innovate using novel technology platforms or validating novel
targets for treating diseases.
Patent expiry impact is modest for the next five years for the
sector as majority have "not so easy to copy" biologics and other
drugs in their portfolio. They however are not complacent and are
not leaving any stones unturned to meet the challenges as well as
exploring emerging market opportunities with local partners.
Favorable regulatory environment should finally see biosimilar
mAbs entry in regulated markets in the next five years. The
optimism of biosimilar players is reflected in the maturing
pipeline.
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Para IV Filing from other generic players continues to pour leaving
room for surprises and volatility.
Global Biopharmaceutical Outlook 2013 of the Mature Biotech
sector released by MP Advisors provides valuations and an in
depth analyses of biotech companies, their launched drug
portfolio and promising drug candidates in the pipeline. The
report discusses the competitive landscape of the targeted
therapy areas and the innovative strategy each company is
deploying to create or retain its leadership in the therapy areas.
Forecast for major marketed drugs and drugs in the pipeline are
included after factoring, competition, and risks from changing
regulatory environment which could change the future market
dynamics. Risk reward analyses of important upcoming
milestones of the companies are included which should help fund
managers as well as pharma company management to make
critical decisions.
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The detailed 110 pages report contains:
Macro Analysis
Performance of the Mature Biotech companies recommended by
MP Advisors in 2012 -report card is very impressive and we
expect the positive sentiments to prevail in 2013 and beyond
Valuation Multiples and Fundamentals- Drivers of Growth.
MP Advisors' Proprietary Sum-of-The-Parts Valuation and Top
Picks for 2013
Drug Approvals 2012-15
Key Milestones During 2013/14
Impact on revenue 2012-2017 from Patent Expiry and Strategies
deployed to meet the challenges.
Pipeline of Biosimilar mAbs
Joint Ventures between innovators and biosimilar players
Merger & Acquisitions Forecast- 2013-2020
In-depth Company Analysis and Reports on
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Acorda - AMPYRA addresses co-morbidities associated with
multiple sclerosis (MS) and with no competition, future growth in
US and EU to sustain the current valuation. Pipeline remains a
free call option.
Alexion - Innovative drugs, diversification and focus on orphan
diseases will continue to lend stability. Availability of Soliris
(eculizumab, C5a inhibitor) indicated for Paroxysmal nocturnal
hemoglobinuria (PNH) and Hemolytic-uremic syndrome (HUS) in
other geographies along with label expansion should drive growth
in the next five years. Pipeline (Asforase alfa, ALXN1102/1103,
ALXN1007) beyond soliris is also maturing.
Amgen - Sales of denosumab (Prolia: Postmenopausal
Osteoporosis, male osteoporosis and XGEVA: skeletal-related
events in patients with bone metastases from solid tumors) and
novel compounds in the pipeline targeting bone health, cancer
and Hypercholesterolemia should sustain Amgen's reputation as
an innovator.
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Through acquisitions and collaboration, Amgen is poised to tap
the emerging market opportunities.
Biogen Idec - Poised to sustain its leadership in MS with the well
awaited launch of the best in class oral therapy BG-12 (dimethly
fumerate, R). Diversification in other therapy area - hemophilia is
the future driver.
Celgene – Leadership in hematological cancers will be sustained
with the launch of pomalidomide. Diversification in autoimmune
and inflammatory diseases and label expansion of marketed
drugs will drive growth. Risk of Para IV challenges remain.
Gilead - Leading in HIV and poised for a similar feat in HCV.
Product pipeline beyond the Anti-viral is maturing and promising.
Grifols – Stable growth in the plasma protein business, while IVIG
opportunity in Alzheimer's disease remains a wild card.
Onyx - Oncology drugs portfolio (Nexavar, Kyprolis, Stivarga) is
attractive and places it high on the acquisition target list.
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Kyprolis is not restricted to R/R MM (3rd-line) and label expansion
in 1st –line MM could be a blockbuster opportunity.
Regeneron – Growth trajectory driven by Eylea in wet Age-related
macular degeneration (AMD), Central Retinal Vein Occlusion
(CRVO) and Diabetic macular edema (DME,). Pipeline targeting
Hypercholesterolemia, Cancer and RA promises long term growth.
Vertex - Bleak prospects for INICVEK as better drugs for HCV are
poised to hit the market. Kalydeco (CF potentiator) in combination
with VX-809/VX-661 (CF corrector) for larger Cystic Fibrosis
opportunity remains a binary event.
Industry Tables
Valuation Snapshots
Expected Drug Clinical Milestones
MB sector Selected M&A Activities
Marketed Products' Potential
Pipeline Potential Thru 2017
Patent Expiry – Impact On The Sector
10. Table of ContentsTable of Contents
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Macro Analysis
• Performance of the Mature Biotech companies recommended by MP Advisors
in 2012 -report card is very impressive and we expect the positive sentiments
to prevail in 2013 and beyond
• Valuation Multiples and Fundamentals- Drivers of Growth.
• MP Advisors' Proprietary Sum-of-The-Parts Valuation and Top Picks for 2013
• Drug Approvals 2012-15
• Key Milestones During 2013/14
• Impact on revenue 2012-2017 from Patent Expiry and Strategies deployed to
meet the challenges.
• Pipeline of Biosimilar mAbs
• Joint Ventures between innovators and biosimilar players
• Merger & Acquisitions Forecast- 2013-2020
In-depth Company Analysis
11. Table of ContentsTable of Contents
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1. Acorda (ACOR)
1.1. Continuing Growth in AMPYRA's Sales
1.2. Ex. US Sales – Risk Factored in the Current Price
1.3. Pipeline Beyond AMPYRA – AC105, diazepam
1.4. Takeover target
1.5. Sum of the parts valuation
1.6. Background
2. Alexion (ALXN)
2.1. Product Pipeline – Future Potential
2.2. Soliris in PNH and aHUS: Growth t-- Continue
2.3. Soliris beyond PNH and aHUS
2.4. Diversifying Beyond Soliris - Asfotase alfa, ALXN1102/ALXN1103,
ALXN1007
2.5. Sum of the parts valuation
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3. Amgen (AMGN)
3.1. Investment Drivers
3.2. Pipeline Products – Promising Progress, AMG145, Romosozumab
3.3. Enriched Pipeline through acquisitions or collaborations -
Blinatumomab, Talimogene laherparepvec, Omecamtiv mecarbil
3.4. Divest Pipeline Products Smartly
3.5. Tapping Emerging markets and other Geographical Expansion
3.6. Strategy for Biosimilars onslaught
3.7. Sum of the parts valuation
3.8. AHA '12 UPDATE: AMG 145 – HYPERLIPIDEMIA
3.9. COMPETITIVE LANDSCAPE: ANTI-PCSK9 MAB – HYPERLIPIDEMIA
4. Biogen Idec (BIIB)
4.1. Catalysts in the Next 6-8 Months – BG-12, recombinant long-lasting
Factor VIII (rFVIIFc) and IX (rFIXFc), Obinutuzumab
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4.2. March of Marketed Products Continues
4.3. Sum of the parts valuation
4.4. OBINUTUZUMAB: PHIII TRIALS
4.5. RITUXIMAB BIOSIMILAR PIPELINE
4.6. Other CNS drugs in the Pipeline
4.7. Biosimilar Development
5. Celgene (CELG)
5.1. Upcoming Key Milestones – Pomalidomide, Apremilast, ABRAXANE
5.2. Negative – Downside risk but not before 2019
5.3. Sum of the parts valuation
5.4. PROTEASOME INHIBITOR - CLINICAL DATA COMPARISON: R/R
MM
6. Gilead (GILD)
6.1. Advancements in the Anti-viral space – HIV and HCV
6.2. Beyond Anti-Virals –
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6.3. Key Catalysts – Sofosubivir, QUAD Pill, Elvitegravir
6.4. Competition from dolutegravir
6.5. Pipeline beyond anti-virals – Ranexa, GS-1101 (PI3K inhibitor)
6.6. Sum of the parts valuation
6.7. KEY PRODUCTS IN PIPELINE: IFN-FREE COMBINATION
6.8. DEVELOPMENT PIPELINE
7. Grifols (GRF)
7.1. Basis of OP recommendation
7.2. IVIG' AD Opportunity – A Wild Card but Not a Risk t-- its Core Business
7.3. Capacity Matters in Plasma Business –
7.4. Weakness
7.5. BACKGROUND - BioScience Division, Diagnostic, Hospital
7.6. NEW PROTEINS IN DEVELOPMENT
7.7. FDA APPROVED PRODUCTS – FRACTIONATED PLASMA
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PRODUCTS
8. Onyx (ONXX)
8.1. Investments drivers – Kyprolis, Oprozomab, Nexavar label expansion
8.2. Sum of the parts valuation
8.3. KYPROLIS: ASH '12 UPDATE
9. Regeneron (REGN)
9.1. Investments drivers
9.2. Upcoming Catalysts – Marketed Products (Eylea, ZALTRAP)
9.3. Upside from Ex-Trap Late -stage Pipeline (REGN727/SAR236553,
Sarilumab, REGN475)
9.4. Sum of the parts valuation
9.5. COMPETITIVE LANDSCAPE: ANTI-PCSK9 MAB – HYPERLIPIDEMIA
9.6. Commercializing strategy
9.7. Manufacturing and Global Supply Chain:
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9.8. VASCEPA vs. LOVAZA & EPANOVA
9.9. CLINICAL DATA COMPARISON IN HYPERTRIGLYCERIDEMIA –
VASCEPA vs. LOVAZA & EPANOVA
10. Vertex (VRTX)
10.1. INCIVEK, KALYDEC-- Label Expansion – Little t-- Bet On,
10.2. Development Plans for IFN-free Combination
10.3. Beyond HCV and CF – VX-509m VX-787, VX-765
10.4. Sum of the parts valuation
10.5. KEY PIPELINE PRODUCTS: IFN-FREE COMBINATION
10.6. DEVELOPMENT PIPELINE
10.7. DATA FROM IFN-FREE COMBINATIONS
Industry Tables
• Valuation Snapshots
• Expected Drug Clinical Milestones
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• MB sector Selected M&A Activities
• Marketed Products' Potential
• Pipeline Potential Thru 2017
• Patent Expiry – Impact On The Sectorn
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https://www.reportscorner.com/reports/10017/Global-Pharmaceutical-&-
Biotechnology-Outlook-2013:-Mature-Biotech/