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Stock Pitch
Nikolai Doytchinov, Jonathan Im, Cheng Ma, Yang Wu, Tej Dhond, Gaurish Gwalani
2
Table of Contents
I. Investment Thesis
II. Industry Overview
III. Company Analysis
IV. Valuation
I. Investment Thesis
4
Gilead Sciences (NASDAQ:GILD)
Recommendation: Buy Current Price: $101.90 Price Target: $115.27 (13% upside)
Gilead’s market leadership in Hepatitis C and HIV treatment, strong cash flow generation, and promising pipeline
combine to create a compelling investment that has been undervalued by the market.
Dominant market position of Hepatitis C treatments Sovaldi and Harvoni
Clinical trials on newer, better drugs including GS5816 and TAF
Recently announced $0.43/share dividend reflects strong cash position and management confidence in continued success
CATALYSTS
RISKS
Uncertainty regarding Sovaldi pricing and Harvoni patent status in light of competition and litigation with AbbVie
Pipeline drugs may not be approved
Expiring patents require development and approval of new drugs to sustain revenue
II. Industry Outlook
6
Industry Outlook
Source: IBISworld Industrial Report
INDUSTRY TRENDS
3 Sub-industries: Medical, Agricultural, and Industrial
Relatively high barriers to entry
Large initial investment
Additional risk of time
Demand curve Vertical
Change in business model
Recession Lack of VC funding
Pharmaceutical partners
Internal sources
Vertical integration Higher profit margins
Higher government regulation
Higher cost for companies
7
Industry Outlook
Source: IBISworld Industrial Report
FUTURE GROWTH
Baby boomers
Domestic market expansion
Consolidation
Broaden product lines
Emerging Markets
Rise of patent expirations
What is a patent?
Typical lifespan: 15 years
Potential acquisition target: biotech firms
Higher profit margins
Profit = $20 - $35
billion
Total tax cost = $75-$90
billion
Biologics Price Competition & Innovation
Act Mandate = $110 billion
Affordable Care Act
Source: Energy & Capital
Source: IBISworld Industrial Report
Bill
ion
s
Bill
ion
s
III. Company Overview
9
Company Overview
Source: Yahoo Finance
Gilead Sciences (GILD)
Biopharmaceutical company
Life-threatening diseases
Founded in June of 1987 by Michael Riordan
Company focus is on anti-viral medicines due to founder
Vast pipeline
BUSINESS OVERVIEW
PERFORMANCE CEO
MBA at Golden Gate University
PhD at University of Chicago (Organic Chemistry)
Year Company Price Importance
2006 Corus Pharma $365 million Respiratory Arena; Cystic Fibrosis
2006 Myogen $2.5 billion Pulmonary diseases
2009 CV Therapeutics $1.4 billion Cardiovascular Franchise
2010 Arresto Biosciences
$225 million Fibrotic diseases; cancer
2011 Pharmasset $10.4 billion Hepatitis C
2015 Phenex Pharmaceuticals
$470 million Liver diseases
John C. Martin
Advancing HCV leadership What is HCV?
Hepatitis C – an often debilitating viral infection impacting the liver
Often asymptomatic and can have long latency periods. Chronic infection can possibly lead to liver failure, potentially liver transplantation.
Sovaldi®/Harvoni® The standard of care for the treatment of HCV
$12bn revenue in 2014; 75% long-term market share
Sovaldi®
A life-altering treatment for HCV; The only approved drug for HCV genotypes 2,3, and 4
Approved in 2013; $85,000 for a 12 week course
High cure rate – 90% vs. 65%
Harvoni®
Superior efficacy (94-99% cure rates) and safety profile for HCV genotype 1 (68% of HCV population)
Approved in 2014; $94,000 for a 12 week course
The backbone of its success: HIV treatment
Dominating HIV therapy
The planet’s top-selling HIV medicines, with ~60% of the 11.7 million patient market
35 million people living with HIV
Multiple therapies targeting on different age groups and drug resistance
$9.24 bn revenue in 2014
Bright future: TAF, less toxic
Antiretroviral therapy (ART)
Stops HIV from reproducing itself and spreading
Keeps the amount of virus in bloodstream so low that not enough to cause symptoms
Rank Naive All Patients
1 Stribild® Atripla®
2 Complera® Complera®
3 Atripla® Stribild®
4 Truvada® + other
3rd Agent Truvada® + other
3rd Agent
5 Other NRTI +
other 3rd Agent Truvada® + other
3rd Agent
Rank Naive All Patients
1 Eviplera® Atripla®
2 Atripla® Eviplera®
3 Truvada® + other
3rd Agent Truvada® + other
3rd Agent
4 Stribild® Truvada® + other
3rd Agent
5 Truvada® + other
3rd Agent Truvada® + other
3rd Agent
Gilead Tops Global Rankings Among HIV Therapies
U.S.
Europe
Sustiva Viread Emtriva Edurant Reyataz
Atripla® ✓ ✓ ✓
Truvada® ✓ ✓ Complera®/
Eviplera® ✓ ✓ ✓
Stribild® ✓ ✓ ✓ ✓ Source: Gilead Sciences Source: Gilead Sciences
12
Other Drugs
Sources: Gilead Sciences, drugs.com, Food and Drug Administration, JP Morgan Equity Research
Treats chronic Hepatitis B (HBV)
Used in combination therapy for HIV-1
On World Health Organization’s List of Essential Medicines
Generated $1.06 bn in revenue in 2014
Patent expires in 2018, leaving just over $3 bn in expected remaining revenues
Viread
Ranexa
Zydelig
Treats chronic angina (chest pain)
More moderately priced that many other Gilead products
Over $500 million in annual sales
Patent protected until 2019
Letairis
Treats Pulmonary Arterial Hypertension (PAH)
Over $500 million in annual sales
Patent protection until 2018
Some residual revenues forecast after expiry
Approved by FDA in July 2014
Patent protected until 2033
Marketing exclusivity granted until 2019
Treats blood cancers
Relapsed chronic lymphocytic leukemia (CLL)
Relapsed follicular B-cell non-Hodgkin lymphoma (FL)
Relapsed small lymphocytic lymphoma (SLL)
Promising expansion into oncology market
Potential for combination therapies
J.P. Morgan Equity Research forecasts expansion to over $1 bn in revenue by 2018
13
Drugs in the pipeline
Source: SEC Filings and S&P Capital IQ
20 new drugs in the pipeline: 1 in NDA, 5 in phase 3, 8 in phase 2, and 6 in phase 1
Shifting focus to oncology products, market with more than $1B in sales last year
Notable products:
TAF (NDA stage)
GS5816 (phase 3)
Simtuzumab (phase 2)
OVERVIEW
TAF
Simtuzumab
General Applications
Oncology and non-oncology applications: NASH, IPF, liver fibrosis
NASH (nonalcoholic steatohepatitis)
Large and expanding market: 2-5% of U.S. population (6M to 16M) are affected, 30% of population in developed countries have less severe form which could deteriorate to NASH.
No optimal treatment is available currently
In Phase 2 clinical trials; data expected in 4Q15
HIV drug in NDA stage
NDA and MAA expects approval in 4Q15.
Positive phase 3 results announced in Sept. 2014.
Improvement on side effects compared to current HIV product
GS5816
Hepatitis C drug in phase 3
12-wk single tablet regimen expected to be effective against all genotype and cirrhotic patients Further secure Gilead’s leading position in the franchise
Phase 3 results expected to come out mid 2015
14
Risks & Mitigation
Drug from main competition AbbeVie is inferior in many fields based on clinical data
Given the company’s past successes, new drugs are likely to be successful as well. Even if a some of the 20 fails, the ones that succeed can drive revenue growth
Will most likely obtain regulatory approval
Will most likely obtain patent
Commercial: competition in the HIV and HCV franchise
Developmental: drugs may fail to prove efficacy in clinical trials
Regulatory: Gilead may fail to secure regulatory approval on new products
Legal: Pending litigation with AbbVie over Harvoni patent; uncertainty regarding intellectual property rights to combination therapies
Risks Mitigation
IV. Valuation
16
Comparable Companies Analysis
Source: SEC Filings and Bloomberg
Company Share Price
(US$) Market Value
(US$mm) Enterprise Value
(US$mm) Rev.
Growth % Current P/E NTM P/E EV/EBITDA EV/EBIT PEG Ratio
AMGEN 153.48 116,747.60 120,436.60 7.4% 16.5 16.2 12.0 13.3 1.57
CELGENE 115.88 92,553.80 92,530.40 18.1% 24.0 23.2 18.1 18.3 0.90
ALEXION 182.29 36,849.70 35,052.70 92.2% 30.8 29.9 25.8 26.3 1.20
REGENERON 402.40 41,293.10 40,390.10 34.0% 37.7 37.0 30.1 35.1 2.07
BIOGEN 391.66 91,889.10 89,163.00 87.9% 23.0 22.6 15.8 16.4 1.29
Mean 249.14 75,866.66 75,514.56 47.92% 26.4 25.78 20.36 21.88 1.41
Median 182.29 91,889.10 89,163.00 34.00% 24.0 23.2 18.1 18.3 1.29
High 402.40 116,747.60 120,436.60 92.20% 37.7 37.0 30.1 35.1 2.07
Low 115.88 36,849.70 35,052.70 7.40% 16.5 16.2 12.0 13.3 0.90
GILEAD 101.90 153,732.90 155,748.70 122.20% 10.7 10.6 8.8 8.7 0.46
Among large-cap biotech peers, Gilead trades at the lowest multiples despite exceptional growth in 2014 and strong projected growth in coming years
Forward P/E of 10.6 and EV/EBITDA of 8.8 suggest undervaluation relative to market even assuming slow future growth
The uniqueness of products and diversity of financial positions of biopharmaceutical companies limits comparability for purposes of valuation
Discounted Cash Flow Analysis (Base Case)
Sources: Bloomberg, JP Morgan Equity Research, Needham Equity Research, SEC filings 17
Discounted Cash Flow (Base Case), cont.
18
Valuation Summary In Millions, except per share
Present Value of Enterprise $169,912.7
Less: Total Debt 9,410.1
Less: Minority Interest 0.0
Less: Preferred Equity 297.4
Plus: Cash 7,691.7
Equity Value $187,311.9
Shares Outstanding 1,625.0
Equity Value Per Share $115.27
Sensitivity Analysis
Exit Discount Rate
Multiple 8.00% 9.00% 10.00% 11.00% 12.00%
8.0x 107.88 104.12 100.54 97.15 93.92
9.0x 115.95 111.82 107.91 104.19 100.65
10.0x 124.02 119.53 115.27 111.22 107.38
11.0x 132.09 127.24 122.63 118.26 114.11
12.0x 140.16 134.95 129.99 125.30 120.84
19
Price Target
Base Case: $115.27 (13% upside)
Revenue estimates based on Bloomberg consensus; 5% revenue CAGR through 2019
85% gross margin; in line with historical
10x exit multiple, implying 2.0% perpetual growth
Bull Case: $130.36 (28% upside)
Revenue estimates based on Bloomberg consensus; 5% revenue CAGR through 2019
88% gross margin; slight improvement from historical, consistent with analyst consensus
11x exit multiple, implying 2.7% perpetual growth
Bear Case: $92.20 (10% downside)
Revenue flat in 2015, followed by 3% CAGR through 2019
85% gross margin; in line with historical
9x exit multiple, implying 1.8% perpetual growth