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SMC Investment Group Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor February 22, 2015 Biotechnology – Health Care Leadership / Governance 73.1 Innovation 69.1 Environment 37.4 Social Impact 70 Work Place 80.2 Economic Sustainability 67.3 Overall 66 52 Week Price Range $63.50-$116.83 Market Capitalization $153.81 billion Dividend Yield N/A Avg. Daily Volume (3M) 17.68M P/E Ratio 16.66 Beta .82 Shares Outstanding 1.5 billion Investment Thesis We give a Buy recommendation for Gilead, due to our belief that it is currently undervalued in the market. With a price of $102.60 as of (2/20/15), the stock is undervalued by 63.3%. The firm has demonstrated a special ability to recognize the unique targets for acquisition, and with strong cash flow and a robust balance sheet, we view M&A as a continued source for value over the foreseeable future. Despite new HCV competitors creating an unfavorable negotiating environment for reimbursement, we view Gilead’s diversified portfolio and pipeline will protect the firm's ability to generate cash flow over the long term. The stock has been outperforming the market over the last two years, as shown below, and we believe that it will continue to do so. Percent Change in Stock Price from April 2012 -50% 50% 150% 250% 350% 450% Apr-12 Oct-12 May-13 Nov-13 Jun-14 Dec-14 S&P 500 Gilead Ticker: NASDAQ: GILD Current Price: $102.60 Recommendation: Buy Price Target: $168 Trading Statistics
Transcript
Page 1: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor

February 22, 2015

Biotechnology – Health Care

Leadership / Governance 73.1 Innovation 69.1

Environment 37.4

Social Impact 70

Work Place 80.2

Economic Sustainability 67.3

Overall 66

52 Week Price Range $63.50-$116.83

Market Capitalization $153.81 billion

Dividend Yield N/A

Avg. Daily Volume (3M) 17.68M

P/E Ratio 16.66

Beta .82

Shares Outstanding 1.5 billion

Investment Thesis

We give a Buy recommendation for Gilead, due to

our belief that it is currently undervalued in the

market.

With a price of $102.60 as of (2/20/15), the stock is

undervalued by 63.3%.

The firm has demonstrated a special ability to

recognize the unique targets for acquisition, and

with strong cash flow and a robust balance sheet,

we view M&A as a continued source for value over

the foreseeable future.

Despite new HCV competitors creating an

unfavorable negotiating environment for

reimbursement, we view Gilead’s diversified

portfolio and pipeline will protect the firm's ability

to generate cash flow over the long term.

The stock has been outperforming the market over

the last two years, as shown below, and we believe

that it will continue to do so. Percent Change in Stock Price from April 2012

-50%

50%

150%

250%

350%

450%

Apr-12 Oct-12 May-13 Nov-13 Jun-14 Dec-14

S&P 500 Gilead

Ticker: NASDAQ: GILD

Current Price: $102.60

Recommendation: Buy

Price Target: $168

Trading Statistics

Page 2: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

2

Major Shareholders (funds)

VA CollegeAmerica

Growth Fund 529F 3.43%

VA CollegeAmerica

Growth Fund 529E 2%

Vanguard Total Stock

Mkt Idx 1.67%

VA CollegeAmerica Cap

World G/I 1.2%

Major Shareholders

(institutions)

Capital Research Global

Investors 8.08%

Fidelity Management &

Research Company 5.84%

Vanguard Group, Inc. 5.24%

State Street Corp. 4.11%

Basic Information

Gilead was founded in 1987 and is located in Foster City, California. It has

been trading on the NASDAQ under the ticker symbol “GILD” since its

IPO in January 1992, when it raised $86.25 million. Currently it is a

component of the S&P 500 as well as of the NASDAQ Biotechnology

index. As of closing on 2/20/15, the market price was $102.60, with a

market cap of $156.7 billion. We feel that the company is currently

undervalued and we give it a recommendation of a “Buy” with a target

price of $168. Gilead has a 30 month average trading volume of

17,196,000, showing that the company’s shares are very liquid.

Investment Summary

On December 22, 2014, shares of Gilead fell by more than 14% on the

announcement that Express Scripts would be sponsoring rival biotech

company AbbVie’s new Hepatitis C cocktail Viekira Pak rather than

Gilead’s new drug Harvoni. This decision by Express Scripts cut

significantly into the niche of Gilead, the HCV market place. By having a

portion of its market share replaced by AbbVie, investors were worried

that Gilead would be unable to replicate the success it had in 2014

moving forward. Since then, the stock price has somewhat recovered,

but the fear in investors remains: such is the nature of investing in

biotech industries. While we do not believe that Gilead will be able to

replicate a 122% sales growth from 2013 to 2014, we do think that Gilead

will continue to slowly grow: we project them to grow by 10% in 2015,

8% in 2016, and 5% in years 2017-2019. With a conservative projection,

we still believe that the stock is currently undervalued (our target price is

$168), primarily due to the risk of Gilead losing even more market share

in its niche. With more people becoming insured through Obamacare

legislation, and with possibility of Gilead releasing new and better drugs

into the marketplace, we feel that they can continue to sustain the

positive momentum of their stock as they have done so for the past few

years.

Business Description

As one of the world’s largest biotechnological companies with business

operations in North & South America, Europe, and Asia Pacific, Gilead

researches, develops, and markets treatments for various chronic

diseases internationally. Founded in Foster City, California in 1987, Gilead

has historically been a producer of treatments of life threatening

diseases, some of which dominate the market as the only or primary

viable prescriptions available for diseases such as HIV, hepatitis B and C,

among others. For this reason, the revenue growth rates for the

company have been extremely high with revenue for 2014 increased

122% from $11.20 billion for 2013 to $24.89 billion for 2014.

Page 3: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

3

Drug Category

Sovaldi HCV

Harvoni HCV

Atripla HIV

Truvada HIV

Stribild HIV

Complera HIV

Viread HIV

Drug FDA Approval*

Sovaldi 2013

Harvoni 2014

Atripla 2006

Truvada 2004

Stribild 2012

Complera 2013

Viread 2001

*year allowed to be sold

Drug 2014 Sales*

Sovaldi $ 8,507

Harvoni $ 2,100

Atripla $ 3,470

Truvada $ 3,340

Stribild $ 1,197

Complera $ 1,228

Viread $ 1,058

*in millions

Drug 2014 Sales*

Sovaldi 34.2%

Harvoni 8.4%

Atripla 13.9%

Truvada 13.4%

Stribild 4.8%

Complera 4.9%

Viread 4.3%

*as percentage of total sales revenue

The company currently has nineteen drugs on the market. Gilead’s most

profitable products are their antiviral medications, which accounted for

93% of the company’s 2014 revenues. Their antiviral offerings include the

drugs Harvoni, Sovaldi, Atripla, Truvada, Stribild, Complera, and Viread.

Sovaldi, a Hepatitis C (HCV) drug that was approved for use in the

United States in December of 2013 (approved one month later in

Europe), was the company’s greatest revenue driver in 2014.

Harvoni, also a hepatitis C drug, is a combination of NS5A inhibitor

Ledipasvir and Sovaldi. It is effective against CHC genotype 1 and can

reduce treatment time down from Sovaldi’s treatment cycle of 12 weeks

to 8 weeks if the patient does not display cirrhosis. Throughout the 3

clinical trials the number of patients achieving sustained viral response

ranged from 94% to 99%. Harvoni was approved by the FDA on October

10, 2014 and generated over $2.1 billion in revenue in the fourth quarter,

exceeding the $1.732B generated by Sovaldi in the same quarter.

Gilead also has an impressive portfolio of HIV drugs. Atripla combines

the medicines Viread, Emtriva, and Sustiva into a single pill. Truvada is a

combination of the drugs Emtriva and Viread and is meant to be taken in

combination with other drugs. Despite being approved in 2004, in 2012

the FDA indicated Truvada, in combination with safer sex practices for

pre-exposure prophylaxis (PrEP), can also reduce the risk of sexually

acquiring HIV in high-risk adults.

Stribild is an HIV treatment combining the four drugs Viketa, Tybost,

Viread, and Emtriva into one pill and is intended for use by treatment-

naïve adults. It received FDA approval in August 2012 and EMA approval

in May of 2013. The next HIV drug is marketed as Complera in the United

States and Eviplera in Europe. It combines Viread, Emtriva, and Edurant

(manufactured by Janssen R&D Ireland). Complera is intended for use as

a complete regimen for patients with no antiretroviral treatment history

and with HIV-1 RNA less than or equal to 50 copies/mL. Janssen

commercializes the product in certain markets. The drug received

approval in both the United States and Europe in 2011. Gilead’s final

major HIV product is Viread. It was approved in the United States in 2001

and 2002 in Europe. It is used to treat patients as young as 2 years old

and received approval in 2008 to treat patients with the Hepatitis B virus.

One of the primary reasons each one of the drugs generates the

revenue that it does is due to the difficulty of getting the drug to the

public. To get a drug into the marketplace, a drug company will analyze

thousands of compounds in search of a viable treatment option for what

they want to treat. Of five thousand compounds analyzed, 5 will typically

Page 4: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

4

Phase 3 Pipeline Candidates

Decease Drug

HIV

STR of

EVG/cobicistat/FTC/

TAF*

HIV

F/TAF

(emtricitabine/tenof

ovir alafenamide) -

Switch Studies

HCV

FDC of SOF/GS-5816

(pan-genotypic

NS5B/NS5A

inhibitors)

HBV

TAF (nucleotide

reverse transcriptase

inhibitor)

Oncology/

inflammation

Idelalisib (PI3K delta

inhibitor) - Frontline

and Relapsed

Refractory CLL

Oncology/

inflammation

Idelalisib (PI3K delta

inhibitor) - iNHL

Oncology/

inflammation

Momelotinib (JAK

inhibitor) -

Myelofibrosis

Cardiovascular

Ranolazine (late

sodium current

inhibitor) -

Incomplete

Revascularization

Post PCI

Cardiovascular

GS-6615 (late

sodium current

inhibitor) - LQT-3

Syndrome

make it to a stage where the company will request approval from the

FDA to begin development. This process of preclinical testing (synthesis,

purification, animal testing) usually takes between 6-7 years. There are

three phases of development:

Phase 1: clinical trials on heathy people (1-2 years)

Phase 2: efficacy trials on target population (1-2 years)

FDA airs concerns and approves protocols for phase 3

Phase 3: safety, efficacy and side effect testing (2-3 years)

During the approval process, manufacturers can get accelerated

development/review if a disease is life threatening and no alternative

treatment is available and if the FDA has deemed it safe for a narrow

population. This means some patients can receive the drug faster and

the approval process is shortened and the manufacturer can begin sales

sooner, cutting R and D costs. After clinical testing the manufacturer files

a New Drug Application (0.6-2 years) and experts are consulted on the

efficacy and safety of the drug, labeling is determined and post-market

surveillance begins (11-14 years).

Gilead’s pipeline of developing drugs is extensive. As it takes between 8-

11 years to have a drug approved by the FDA, and the likelihood of

approval is extremely low it is important to have numerous possible

drugs in different stages of development. As of now, Gilead has 30

products in the pipeline.

To sell their newly created drugs, biotech companies can group up with

a Pharmacy Benefit Manager (PMB) to help distribute and supply a firm’s

drug to the people who need it. The majority of Americans receive their

prescription drugs with the help of a PMB. PMBs also work out discounts

for various drugs with their associated manufacturers. Express Scripts, a

PMB, only carries hepatitis C drugs made by AbbVie whereas PMBs CVS

and Blue Cross carry the hepatitis C drug made by Gilead Sciences.

Management & Governance

The highest leadership of Gilead consists of scientists who know how

their products work and what it takes to research and develop them. The

Chairman and Chief Executive, John C. Martin PhD, has been with Gilead

for over two decades, holding advanced degrees in organic chemistry

and marketing. In addition to many other notable accomplishments, he

served as President of the International Society for Antiviral Research.

John Milligan is the president and COO. He held the CFO position

directly before stepping into his current role. Like Martin, he also joined

the company in 1990. He has a PhD in biochemistry. Milligan was named

Bay Area CFO of the Year for companies with revenues greater than

Page 5: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

5

Board of Directors

Director Year

Joined

John C. Martin, PhD 1990

John F. Cogan, PhD 2005

Etienne F. Davignon 1990

Carla A. Hills 2007

Kevin E. Lofton 2009

John W. Madigan 2005

Nicholas G. Moore 2004

Richard J. Whitley,

MD 2008

Gayle Edlund Wilson 2001

Per Wold-Olsen 2010

$500 million in 2006 and was named the top biotechnology CEO in the

country in 2006, 2007, and 2008.

The leadership of the company has been the primary reason it has

grown to what it is today. While most of Gilead’s growth has been

organic, a big reason for their success occurred when they acquired

Pharmasset in January of 2012 for $10.8 billion. At the time many industry

experts claimed this purchase price was much too high, however Gilead

developed Pharmasset’s medication PSI-7977 into the marketed drug

Sovaldi, which generated over $10 billion in revenue last year alone. This

is just one of the many successful company buyouts that Gilead has had.

In their acquisitions alone, the management has demonstrated that they

know how to continue to grow Gilead in years to come.

Industry Overview & Competitive Positioning

Within the biotech industry there are hundreds of companies

specializing in developing treatments for a wide range of diseases. The

biggest advantage that a biotechnology company can have is simply

being first to effectively treat a disease, and take hold of the majority of

that market. Getting FDA approval and launching a product into the

market at the right time can be the difference between a firm

skyrocketing to the top of the industry or suffering massive losses due to

not being able to recoup their costs of R&D. This results in the

biotechnology industry becoming an increasingly competitive space.

As you can see from the graph on the left, in 2014, Gilead spent the

lowest on R&D when compared to some of its industry peers. Gilead’s

$11 billion acquisition of Pharmasset helped to drive down their R&D

costs since Pharmasset worked on developing antiviral drugs for

hepatitis C and HIV (the two largest markets targeted by Gilead).

The threat of a new firm entering the biotech industry and immediately

jumping to the top is highly unlikely, due to the biotech industry having

high barriers of entry. To begin a clinical study on a drug, a firm has to

get their product FDA approved. This FDA approval process goes

through 3 separate phases and can take anywhere from 8 to 11 years to

complete. Statistically only 1 to 2 drugs out of every 20 that enter the

FDA to get tested make it into the market. Biotech companies also have

expensive research and development costs, some in the range of over

$10 billion annually. If another large firm already owns the majority of the

market share of a particular illness, attempting to take over a part of that

market share would be incredibly difficult since the other firm has been

established in that area. Gilead is successful and will remain successful

due to owning the majority of market share for HVC & HIV drugs.

Page 6: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

6

Competitor 2014 EPS

Gilead 5.80

AbbVie 1.60

Bristol-Myers Squib 1.20

Merck and Co. 1.57

Pfizer 1.23

Amgen 6.70

Celgene 1.66

Number of Insured

Americans

2010 258.88

2011 262.76

2012 265.73

2013 270.61

2014 276.17 *in millions

Sales Growth Rate

2012 16.5%

2013 15.45%

2014 122.19%

2015* 10%

2016* 8%

2017* 5%

2018* 5%

2019* 5% *projected

Within the biotech industry there are hundreds of companies

specializing in developing treatments for a wide range of diseases. The

biggest advantage that a biotechnology company can have is simply

being first to effectively treat a disease, and take hold of the majority of

that market. Getting FDA approval and launching a product into the

market at the right time can be the difference between a firm

skyrocketing to the top of the industry or suffering massive losses due to

not being able to recoup their costs of R&D. This results in the

biotechnology industry becoming an increasingly competitive space.

Since 2010, the Biotechnology Industry and Gilead have given a return of

153% and 206%, respectively, compared to the S&P 500 which only gave

a return of 79% in that same time frame. We believe that this flow of

capital into the biotechnology industry can be traced back to the

inception of the Affordable Care Act in 2010. The introduction of the

Affordable Care Act in 2010 has led to an increase in patients having

access to various medical professionals and their associated facilities.

Around 6.5 million people enrolled in 2014 and 9 million more people

are expected to enroll in 2015. This influx of new patients has resulted in

an increase in demand for pharmaceutical drugs and medical devices,

which in turn caused an inflow of capital into the biotechnology and

health-care sector resulting in increased share prices of many companies

in the health-care sector.

Valuation

Based on a discounted cash flow valuation, we believe that Gilead should

be worth $167.53 per share. Our target price is based off a sales growth

rate projection of 10% in 2015, 8% in 2016, and 5% each year from 2017-

2019, and a weighted average cost of capital of 9.04%. Over the last few

years, Gilead sales growth has been remarkable, with an increase of

15.45% from 2012 to 2013, and then a 122.19% increase from 2013 to

2014. The reason for the increase in sales is due to Sovaldi, a treatment

for chronic hepatitis C, becoming available on the market. In 2014,

Sovaldi generated $10.3 billion in sales for Gilead, which was 41.4% of

total sales for the year.

While Gilead has over 30 drugs in the pipeline, we did not take into

account any potential new drugs being available in the market due to

the difficulty of getting a drug approved by the Federal Drug

Administration. In addition, any profit that could be made with a new

drug hitting the marketplace could be offset with a loss in market cap by

a current drug, as seen in late December when it was announced that

insurance company Express Scripts has chosen to sponsor rival AbbVie

Page 7: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

7

Sales Revenue (in millions)

2012 $9,703

2013 $11,202

2014 $24,890

2015* $27,379

2016* $29,569

2017* $31,047

2018* $32,600

2019* $34,230 *projected

Weighted Average Cost of

Capital Risk Free Rate 1%

Beta 1.1

Market Risk Premium 10

%

Cost of Equity 12

%

After Tax Cost of Debt 4%

Target Debts to Assets

Ratio

37

%

WACC 9.04

%

HCV drugs, which cut significantly into Sovaldi’s market cap and

dropped the stock price by 14%. The Express Scripts decision is worth

$3-4 billion in lost sales to Gilead. The combination of unknown

potential of a new drug combined with the potential risk in the loss of

market cap of a current drug led us to have a relatively conservative

projected sales growth rate.

For our valuation, we used a Weighted Average Cost of Capital of 9.04%.

We believe that the listed beta, .82, is not the true beta of the company,

as the investment in a biotech firm will lead to higher return on

investment then investing in the market index; therefore, we used a beta

of 1.1 in our calculations. We believe the annual market risk premium

over the next five years will be 10%, and with a long term growth rate of

cash (inflation) at 3%, we believe the equity value of Gilead is $252,752,

which results in a per-share equity value of $167.53.

As of 2013 Gilead has 200 active clinical studies with 60 of those studies

in phase three of the FDA approval process. Around 90% of the drugs in

Phase 3 make it to the market; we believe this gives Gilead a very strong

pipeline given the number of drugs the company has in phase three. On

top of having twenty drugs in phase three, Gilead owns about 70% of

the global hepatitis C market and treats 85% of HIV patients in the US.

We feel that due to the of Gilead’s presence in the HIV and hepatitis C

drug markets will make it difficult for rivals to encroach on their market

share.

Gilead is planning to cut prices on their hepatitis C drugs Harvoni and

Sovaldi in 2015 in response to competition from AbbVie. We think that

this discounting of Harvoni and Sovaldi will allow Gilead to maintain and

grow their 70% market share in the hepatitis C drug market, even

though AbbVie and Bristol-Myers Sqibb are releasing their own hepatitis

C drugs. Harvoni and Sovaldi’s high rate of success of has lead

physicians to use Gilead’s drugs over its competitor’s drugs. Gilead also

has patents filed on its hepatitis C drugs, keeping the medication

protected until 2029.

Gilead drugs currently treat around 85% of the HIV patients in the US

and 7 million people worldwide in over 125 countries worldwide. Despite

the fact that patents central to Gilead’s HIV drugs will begin to expire in

2018, the firm’s newer HIV drugs are patent protected. We think that

based on its history and large number of drugs in its pipeline, the firm

will be able to have a competitive advantage in new drug therapy

markets in the future.

Page 8: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

8

We also believe that the growing number of individuals that are

becoming insured through the Affordable Care Act will cause an increase

in demand for goods and services provided by the healthcare and

biotechnology industry. To Gilead, this would be an opportunity to treat

new patients who previously went un-diagnosed resulting in the growth

of the company and its wide economic moat.

Financial Analysis

Over the last several years Gilead has leveraged its wide margins to

consistently drive incremental profit through to its bottom line. Its ability

to retain about 45% of revenue over the last twelve months has allowed

the firm opportunities to reinvest in R&D, M&A, and, more recently, its

shareholders. In its 2014 year end conference call, management

announced it will pay a 43 cent per share dividend, which implies a yield

of about 1.5% and places Gilead among only a handful of large

pharmaceutical companies to pay a dividend.

In the call, management also said it will buyback an additional $15 billion

of its shares to supplement the current $3 billion repurchase program.

CFO Robin Washington said that despite the decision to return such an

aggressive amount of value to shareholders, the firm’s balance sheet

remains robust and that money will still be available to maintain R&D

and even invest in M&A, which has been an important theme for the

players in the space.

We believe that this trend will continue. Many criticized Gilead’s $11

billion acquisition of Pharmasset in 2012, but the firm has already

recovered its investment thanks to Solvadi’s record setting sales in 2014.

And Gilead currently maintains over $11 billion in cash and cash

equivalents, which should provide ample cushion to remain acquisitive.

Management also guided for 2015 sales between $26 billion-$27 billion,

which is in line with our estimates. HCV and HIV treatments together

generated roughly $13 billion in operating income in 2014, and

management expects numbers to be even better in 2015.

For fiscal year 2014, sales increased 122% from $11 billion to $24.9 billion

on the back of Solvadi and Harvoni, which together brought in $12.4

billion. Gross margins increased at an even faster rate, signaling Gilead’s

ability to control prices in the marketplace. 2014 operating margins came

in at 58% with R&D and SG&A together accounting for just over 10% of

sales. Net income increased year over year from $3 billion to $12 billion,

which drove 2014 EPS to $7.35 from $1.81 in 2013.

0

500

1,000

1,500

2,000

2,500

3,000

3,500

4,000

4,500

Operating Cash Flow (millions)

0

1,000

2,000

3,000

4,000

5,000

6,000

7,000

8,000 Sales (millions)

Page 9: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

SMC Investment Group February 22, 2015

9

2014 Industry Sales Growth

Gilead 122.2%

AbbVie 7.01%

Bristol-Myers Squib -3.09%

Merck and Co. -4.08%

Pfizer -3.84%

Amgen 7.43%

Celgene 17.9%

Fourth quarter EPS came in at 2.43 on revenue of $7.3 billion, versus

analyst estimates of $2.16 EPS on revenue of $6.67 billion. Sales in the

period were up from $3.1 billion in the same period last year. While our

HIV sales estimates were in line with results, management said that

Hepatitis C discounts rose higher than we expected in 2015. Over the last

few years, Gilead has grown revenue at a much higher rate than any of

its competitors (see side, full chart in Appendix 4).

With Abbvie’s introduction of Viekira Pak to the market during the

second half of 2014, Gilead Sciences has been under increasing pressure

to discount its blockbuster HCV treatments, Solvaldi and Harvoni. Before

Abbvie’s treatment, Gilead had the only treatment on the market, and

was able to charge a whopping $95,000 per patient in the US. The

insurance and pharmaceutical benefits space is dominated by only a few

large players, which were able to negotiate with Gilead to receive an

average discount on the price tag of about 22% in 2014.

However, with Abbvie’s entry into the market, Gilead has been under

immense pressure to further discount its treatments. On the fourth-

quarter conference call, management shed light on how deep discounts

can go. It said that the 22% 2014 gross to net ratio was steeper-than-

expected, and that it expects a 46% gross to net ratio for 2015. Shares

slid that day more than 5 percent.

Both AbbVie and Gilead have fought for market share by cutting deals

with group payers. First, AbbVie struck a deal with Express Scripts, the

largest player in the space. Express Scripts' roughly 30% market share for

US prescription drugs combined with the 30% of its customers that are

loyal to the formulary (list of accepted drugs), translates into at least 10%

of the total HCV-infected US patients who will take AbbVie’s regimen

next year.

But Gilead answered back by negotiating with CVS, the number two

player. As Gilead further discounts its treatments, it also seeks to treat

more hepatitis C patients insured through Medicare and the Veterans

Administration, where gross-to-net adjustments are more than 50%.

Essentially, Gilead is signaling that while it offers bigger discounts, it will

increase the number of hepatitis C patients treated to make up for the

lost sales.

Investment Risks

Negotiating environments with insurance companies and pharmacy

benefit managers can continue to worsen as AbbVie continues to battle

for market share. Competitors continue to push hard to develop HCV

-80%

-60%

-40%

-20%

0%

20%

40%

60%

80%

100%

120%

140%

2011 2012 2013 2014

Yearly Revenue Growth

Gilead

AbbVie

Bristol-Myers Squib

Merck and Co.

Pfizer

Amgen

Celgene

Page 10: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

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10

Patent Expiration Product U.S. E.U

Hepsera 2014 2016

AmBisome 2016 2008

Macugen 2017 2017

Tamiflu 2017 2016

Letairis 2018 2020

Viread 2018 2018

Ranexa 2019 2023

Atripla 2021 2018

Cayston 2021 2021

Emtriva 2021 2016

Truvada 2021 2018

Lexiscan 2022 2025

Complera 2023 2022

Vitekta 2023

Sovaldi 2029 2028

Striblid 2029 2028

Tybost 2027

Harvoni 2029 *projected

treatments, notably Merck and Bristol, which look capably of bringing

regimens to market by 2016.

In the biotech market, the power of the buyer is very influential, as seen

by the Express Scripts decision dropping the price of Gilead’s stock.

Pharmacy Benefit Managers (PBM) governments, hospitals, and other

entities that buy drugs and medical devices from biotech firms can have

an effect on what price the firm sells its products for. If a biotech firm

tries selling a drug at too high of a price, the particular entity that is

buying or was planning on buying might end up not buying at all or

would attempt to get the drug at a discount. This can be seen in today’s

biotech market where “price wars” between firms have begun in an

attempt to gain market share and increase sales. The power of the buyer

can result in lost revenue for a biotech firm if they discount their product

too deeply.

A major hit to sales in pharmaceuticals is typically felt when the patent of

a profitable drug expires. Generic companies can produce the drug at

low costs because they do not need to spend money on research and

development, only production. Gilead’s main drugs are protected for

over a decade as the most profitable drug up for patent expiration is

Ambisome in 2016 which is the company’s tenth most profitable drug.

Biotech firms use patents to make sure that no other company can steal

their market share or drug formula. Foreign countries might not uphold

the patent laws of another country which can result in the illegal

production of a drug for significantly lower prices. If a biotech firm relies

heavily on international sales, this could damage their revenue.

Substitute drugs can cause a shift in market share if a biotech firm

develops a drug that is similar to another firm’s drug, but sells it for a

cheaper price. This is the threat that generic drugs pose to biotech firms

that try to maintain the exclusivity of their drug in their respective

markets.

The competitive nature of the biotech industry makes this stock a very

risky investment due to the numerous factors that drive the stock price

up or down. A drug not passing the FDA regulations or a new drug

being awarded a contract that Gilead previously had can hamper future

earnings and drive the stock price down, as seen by the 14% drop in late

December 2014.

Page 11: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

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11

Appendix 1:

Gilead

Financial Statements

Year 2014 2013 2012 2014 2013 2012 Average 2014 2013

Income statement (amounts in millions) Common-Size (% Sales) Trend (% Change)

Sales 24,890.00 11,202.00 9,703.00 100.00% 100.00% 100.00% 100.00% 122.19% 15.45%

Costs of Goods Sold (COGS) 3,788.00 2,859.00 2,471.00 15.22% 25.52% 25.47% 22.07% 32.49% 15.70%

Gross Profit 21,102.00 8,343.00 7,232.00 84.78% 74.48% 74.53% 77.93% 152.93% 15.36%

Research and Development 2,737.00 2,120.00 1,760.00 11.00% 18.93% 18.14% 16.02% 29.10% 20.45%

Selling, General & Administrative expenses (SG&A) 2,964.00 1,699.00 1,461.00 11.91% 15.17% 15.06% 14.04% 74.46% 16.29%

Depreciation and Amortization 18.00 0.00 0.00 0.07% 0.00% 0.00% 0.02% #DIV/0! #DIV/0!

Other Expenses 118.00 0.47% 0.00% 0.00% 0.16% #DIV/0! #DIV/0!

Earnings Before Interest and Taxes (EBIT) 15,265.00 4,524.00 4,011.00 61.33% 40.39% 41.34% 47.68% 237.42% 12.79%

Net Interest Income (Expense) -409.00 -316.00 -399.00 -1.64% -2.82% -4.11% -2.86% 29.43% -20.80%

Earnings Before Tax (EBT) 14,856.00 4,208.00 3,612.00 59.69% 37.56% 37.23% 44.83% 253.04% 16.50%

Provision for Income Tax 2,797.00 1,151.00 1,038.00 11.24% 10.27% 10.70% 10.74% 143.01% 10.89%

Earnings After Tax (EAT) 12,059.00 3,057.00 2,574.00 48.45% 27.29% 26.53% 34.09% 294.47% 18.76%

Net Earnings (loss) attributable to Gilead 42.00 18.00 18.00 0.17% 0.16% 0.19% 0.17% 133.33% 0.00%

Net Earnings or Net Income 12,101.00 3,075.00 2,592.00 48.62% 27.45% 26.71% 34.26% 293.53% 18.63%

Dividends Paid 0.00 0.00 0.00 0.00% 0.00% 0.00% 0.00% #DIV/0! #DIV/0!

Retained Earnings 0.00 3,075.00 2,592.00

Shares Outstanding (Basic) 1,508.66 1,529.00 1,515.00

Shares Outstanding (Diluted) 1,500.01 1,695.00 1,583.00

Balance sheet

Cash and Short Term Marketable Securities 11,726.00 2,571.00 1,804.00 47.11% 22.95% 18.59% 29.55% 356.09% 42.52%

Accounts Receivables (A/R) 4,635.00 2,182.00 1,751.00 18.62% 19.48% 18.05% 18.72% 112.42% 24.61%

Inventory 1,386.00 1,697.00 1,745.00 5.57% 15.15% 17.98% 12.90% -18.33% -2.75%

Other Current Assets 0.00 0.00 347.00 0.00% 0.00% 3.58% 1.19% #DIV/0! -100.00%

Operating Current Assets 6,021.00 3,879.00 3,843.00 24.19% 34.63% 39.61% 32.81% 55.22% 0.94%

Total Current Assets 17,747.00 6,450.00 5,647.00 71.30% 57.58% 58.20% 62.36% 175.15% 14.22%

Long Term Investments 0.00 0.00 0.00 0.00% 0.00% 0.00% 0.00% #DIV/0! #DIV/0!

Net Fixed Assets 1,674.00 1,166.00 1,674.00 6.73% 10.41% 17.25% 11.46% 43.57% -30.35%

Goodwill and Other Intangibles 12,245.00 13,069.00 13,584.00 49.20% 116.67% 140.00% 101.95% -6.30% -3.79%

Other Long Term Assets 2,998.00 1,894.00 335.00 12.04% 16.91% 3.45% 10.80% 58.29% 465.37%

Total Long Term Assets 16,917.00 16,129.00 15,593.00 67.97% 143.98% 160.70% 124.22% 4.89% 3.44%

Total Assets 34,664.00 22,579.00 21,240.00 139.27% 201.56% 218.90% 186.58% 53.52% 6.30%

Short Term Debt / Accrued Expenses 1,872.67 2,135.67 1,570.00 7.52% 19.07% 16.18% 14.26% -12.31% 36.03%

Accounts Payable (A/P) 1,872.67 2,135.67 1,327.00 7.52% 19.07% 13.68% 13.42% -12.31% 60.94%

Other Current Liabilities 1,872.67 2,135.67 1,341.00 7.52% 19.07% 13.82% 13.47% -12.31% 59.26%

Operating Current Liabilities 3,745.33 4,271.33 2,668.00 15.05% 38.13% 27.50% 26.89% -12.31% 60.09%

Total Current Liabilities 5,618.00 6,407.00 4,238.00 22.57% 57.20% 43.68% 41.15% -12.31% 51.18%

Long Term Debt 13,212.00 4,363.00 7,055.00 53.08% 38.95% 72.71% 54.91% 202.82% -38.16%

Other Long Term Liabilities 0.00 0.00 644.00 0.00% 0.00% 6.64% 2.21% #DIV/0! -100.00%

Total Liabilities 18,830.00 10,770.00 11,937.00 75.65% 96.14% 123.02% 98.27% 74.84% -9.78%

Common Stock 0.00 0.00 2.00 0.00% 0.00% 0.02% 0.01% #DIV/0! -100.00%

Accumulated Retained Earnings 15,819.00 11,745.00 3,705.00 63.56% 104.85% 38.18% 68.86% 34.69% 217.00%

Other Stockholder Equity 15.00 64.00 5,596.00 0.06% 0.57% 57.67% 19.43% -76.56% -98.86%

Total Stockholders Equity 15,834.00 11,809.00 9,303.00 63.62% 105.42% 95.88% 88.30% 34.08% 26.94%

Total Liabilities and Equity 34,664.00 22,579.00 21,240.00 139.27% 201.56% 218.90% 186.58% 53.52% 6.30%

Page 12: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

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12

Appendix 2: Pro Forma Statements

Gilead

Pro Forma Statements

Model Parameters 2014 2015 2016 2017 2018 2019

Sales Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

COGS/Sales 15.22% 15.00%

R&D/Sales 11.00% 11.00%

SG&A/Sales 11.91% 12.00%

Depreciation/Sales 0.07% 1.00%

Other Expenses/Sales 0.47% 0.50%

A/R Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Inventory Turnover 17.96 18.00

Other Current Assets Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Long Term Investments/Sales 0 1.00%

Net Fixed Assets Turnover 14.87 15.00

Goodwill & Other Intangibles Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Other Long Term Assets Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Short Term Debt/Sales 0.075237713 8.00%

A/P Turnover (based on COGS) 2.02 2.00

Other Current Liabilities Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Long Term Debt Repayment Per Year 1 1.00

Other Long Term Liabilities Growth Rate 10.00% 8.00% 5.00% 5.00% 5.00%

Common Stock/Sales 0

Other Stockholder Equity/Sales 0.000602652 0.00

Net Interest Expense Rate 0.288508557 0.30

Tax Rate

Dividend Payout Ratio

Actual

Year 2013 2014 2016 2017 2018 2019

Income statement (amounts in millions)

Sales 24,890.00 27,379.00 29,569.32 31,047.79 32,600.18 34,230.18

Costs of Goods Sold (COGS) 3,788.00 4,106.85 4,435.40 4,657.17 4,890.03 5,134.53

Gross Profit 21,102.00 23,272.15 25,133.92 26,390.62 27,710.15 29,095.66

Research and Development 2,737.00 3,011.69 3,252.63 3,415.26 3,586.02 3,765.32

Selling, General & Administrative expenses (SG&A) 2,964.00 3,285.48 3,548.32 3,725.73 3,912.02 4,107.62

Depreciation and Amortization 18.00 273.79 295.69 310.48 326.00 342.30

Other Income (Expense) -118.00 136.90 147.85 155.24 163.00 171.15

Earnings Before Interest and Taxes (EBIT) 15,265.00 16,838.09 18,185.13 19,094.39 20,049.11 21,051.56

Net Interest Income (Expense) -409.00 -449.90 -485.89 -510.19 -535.70 -562.48

Earnings Before Tax (EBT) 14,856.00 17,287.99 18,671.02 19,604.57 20,584.80 21,614.04

Provision for Income Tax 2,797.00 0.00 0.00 0.00 0.00 0.00

Earnings After Tax (EAT) 12,059.00 17,287.99 18,671.02 19,604.57 20,584.80 21,614.04

Net Earnings (loss) attributable to Blackberry 0.00 0.00 0.00 0.00 0.00 0.00

Net Earnings or Net Income 12,059.00 17,287.99 18,671.02 19,604.57 20,584.80 21,614.04

Dividends Paid 0.00 0.00 0.00 0.00 0.00 0.00

Retained Earnings 12,059.00 17,287.99 18,671.02 19,604.57 20,584.80 21,614.04

Balance sheet

Cash and Short Term Marketable Securities 11,726.00 28,887.18 46,679.20 65,690.12 85,651.63 106,611.27

Accounts Receivables (A/R) 4,635.00 12,898.60 13,930.49 14,627.01 15,358.36 16,126.28

Inventory 1,386.00 1,521.06 1,642.74 1,724.88 1,811.12 1,901.68

Other Current Assets 0.00 5,098.50 5,506.38 5,781.70 6,070.78 6,374.32

Operating Current Assets 6,021.00 19,518.16 21,079.61 22,133.59 23,240.27 24,402.28

Total Current Assets 17,747.00 48,405.34 67,758.81 87,823.70 108,891.90 131,013.55

Long Term Investments 0.00 273.79 295.69 310.48 326.00 342.30

Net Fixed Assets 1,674.00 1,825.27 1,971.29 2,069.85 2,173.35 2,282.01

Goodwill and Other Intangibles 12,245.00 0.00 0.00 0.00 0.00 0.00

Other Long Term Assets 2,998.00 1,841.40 1,988.71 2,088.15 2,192.55 2,302.18

Total Long Term Assets 16,917.00 3,940.46 4,255.69 4,468.48 4,691.90 4,926.50

Total Assets 34,664.00 52,345.80 72,014.50 92,292.18 113,583.80 135,940.05

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Appendix 3: Free Cash Flow Calculation

Appendix 4: Yearly Revenue Growth Rate for Industry

Year 2013 2014 2016 2017 2018 2019

Short Term Debt 1,872.67 2,190.32 2,365.55 2,483.82 2,608.01 2,738.41

Accounts Payable (A/P) 1,872.67 2,053.43 2,217.70 2,328.58 2,445.01 2,567.26

Other Current Liabilities 1,872.67 2,059.93 2,224.73 2,335.96 2,452.76 2,575.40

Operating Current Liabilities 3,745.33 4,113.36 4,442.43 4,664.55 4,897.78 5,142.66

Total Current Liabilities 5,618.00 6,303.68 6,807.97 7,148.37 7,505.79 7,881.08

Long Term Debt 13,212.00 3,744.33 3,743.33 3,742.33 3,741.33 3,740.33

Other Long Term Liabilities 0.00 6,179.80 6,674.18 7,007.89 7,358.29 7,726.20

Total Liabilities 18,830.00 16,227.81 17,225.49 17,898.60 18,605.41 19,347.61

Common Stock 0.00

Accumulated Retained Earnings 15,819.00 36,117.99 54,789.01 74,393.58 94,978.39 116,592.43

Other Stockholder Equity 15.00 0.00 0.00 0.00 0.00 0.00

Total Stockholders Equity 15,834.00 36,117.99 54,789.01 74,393.58 94,978.39 116,592.43

Total Liabilities and Equity 34,664.00 52,345.80 72,014.50 92,292.18 113,583.80 135,940.05

Year 2013 2014 2015 2016 2017

Free Cash Flow calculation

Earnings After Tax (EAT) 17,288 18,671 19,605 20,585 21,614

Add back Depreciation 274 296 310 326 342

Subtract increase in Operating Current Assets 13,497 1,561 1,054 1,107 1,162

Add back increase in Operating Current Liabilities 368 329 222 233 245

Subtract Net Capital Spending (NCS) 425 442 409 429 451

Add back After-Tax Net Interest Expense -450 -486 -510 -536 -562

Free Cash Flow (FCF) 3,558 16,807 18,164 19,072 20,026

-80%

-60%

-40%

-20%

0%

20%

40%

60%

80%

100%

120%

140%

2008 2009 2010 2011 2012 2013 2014

Yearly Revenue Growth Rate

Gilead AbbVie Bristol-Myers Squib Merck and Co. Pfizer Amgen Celgene

Page 14: February 22, 2015 Biotechnology Health Care · 2015. 4. 9. · Covering Analysts: Simon Tryzna, Brett Lyons, Amrit Saini, Alyssa Horning, Thomas Taylor SMC Investment Group February

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Appendix 5: Growth of 10,000


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