analyst: victor sula, ph.d. initial report january

7
Analyst: Victor Sula, Ph.D. Initial Report January 9th, 2008 Background MARKET DATA Symbol Current price Low/ High 52 weeks Average Volume Market Capitalization Shares Outstanding Source: Yahoo Finance, Analyst Estimates AMGN $57.93 $39.16 - 66.51 6,040,625 $22.014 Bn 1,059 Mn Revenues, $ Mn. Gross margin Operating margin Net margin EPS, $ 13,858 85.3% 26.9% 20.7% 3.51 14,311 82.8% 26.9% 21.4% 3.86 11,026 82.4% 26.5% 21.1% 2.05 11,252 84.5% 36.2% 28.8% 3.00 2.0% 2.1 b.p. 9.7 b.p. 7.7 b.p. 46.3% 3.3% -2.5 b.p. 0.0 b.p. 0.7 b.p. 10.0% Amgen Inc. (AMGN, the Company) is a global biotechnology company en- gaged in the discovery, development, manufacture and commercialization of human therapeutics based on advances in cellular and molecular biology. The Company has research programs in metabolic disorders and osteoporo- sis, inflammation, oncology, neuroscience and hematology. AMGN is consid- ered to be the largest independent biotechnology company in the U.S., and the only business that succeeded to transform itself from a drug development company into a pharmaceutical manufacturer with solid sales. The Company’s principal products include: Aranesp (darbepoetin alfa) and EPOGEN (Epoetin alfa), which stimulate the production of red blood cells to treat anemia and belong to a class of drugs referred to as erythropoiesis- stimulating agents (ESAs); Neulasta (pegfilgrastim) and NEUPOGEN (Fil- grastim), which selectively stimulate the production of neutrophils, a type of white blood cell that helps the body fight infections; and ENBREL (etan- ercept) that blocks the biologic activity of tumor necrosis factor by inhibiting volume 62 60 58 56 54 52 50 48 46 30 20 10 0 © BigCharts.com Millions Share Statistics (12/23/08) NASDAQ 2006 2007 %Chg %Chg 9m 2007 9m 2008 01/8/09 AMGNdaily Nov Dec 09 Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 Phone: +1 805-447-1000 Fax: +1 805-447-1010 Website: www.amgen.com

Upload: beacon-equity

Post on 11-Mar-2016

213 views

Category:

Documents


0 download

DESCRIPTION

TNF, a substance induced in response to inflammatory and immunological responses, such as rheumatoid ar- thritis and psoriasis. Other marketed products include Sensipar, Nplate and Vectibix. Despite the financial crisis, the Company, due to its conservative investment portfolio, does not have exposure to subprime mortgages and other risky investments.

TRANSCRIPT

Page 1: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 1

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Background

MARKET DATA

Symbol

Current price

Low/ High 52 weeks

Average Volume

Market Capitalization

Shares Outstanding

Source: Yahoo Finance, Analyst Estimates

AMGN

$57.93

$39.16 - 66.51

6,040,625

$22.014 Bn

1,059 Mn

Revenues, $ Mn.

Gross margin

Operating margin

Net margin

EPS, $

13,858

85.3%

26.9%

20.7%

3.51

14,311

82.8%

26.9%

21.4%

3.86

11,026

82.4%

26.5%

21.1%

2.05

11,252

84.5%

36.2%

28.8%

3.00

2.0%

2.1 b.p.

9.7 b.p.

7.7 b.p.

46.3%

3.3%

-2.5 b.p.

0.0 b.p.

0.7 b.p.

10.0%

Amgen Inc. (AMGN, the Company) is a global biotechnology company en-gaged in the discovery, development, manufacture and commercialization of human therapeutics based on advances in cellular and molecular biology. The Company has research programs in metabolic disorders and osteoporo-sis, inflammation, oncology, neuroscience and hematology. AMGN is consid-ered to be the largest independent biotechnology company in the U.S., and the only business that succeeded to transform itself from a drug development company into a pharmaceutical manufacturer with solid sales.

The Company’s principal products include: Aranesp (darbepoetin alfa) and EPOGEN (Epoetin alfa), which stimulate the production of red blood cells to treat anemia and belong to a class of drugs referred to as erythropoiesis-stimulating agents (ESAs); Neulasta (pegfilgrastim) and NEUPOGEN (Fil-grastim), which selectively stimulate the production of neutrophils, a type of white blood cell that helps the body fight infections; and ENBREL (etan-ercept) that blocks the biologic activity of tumor necrosis factor by inhibiting

volume

62

60

58

56

54

52

50

48

46

30

20

10

0

© BigCharts.com

Mill

ions

Share Statistics

(12/23/08)NASDAQ

2006 2007 %Chg %Chg

9m

2007

9m

2008

01/8/09AMGNdaily

Nov Dec 09

Amgen Inc.One Amgen Center DriveThousand Oaks, CA91320-1799

Phone: +1 805-447-1000Fax: +1 805-447-1010Website: www.amgen.com

Page 2: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 2

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 2

TNF, a substance induced in response to inflammatory and immunological responses, such as rheumatoid ar-thritis and psoriasis. Other marketed products include Sensipar, Nplate and Vectibix.

The Company’s research facilities are located in California, Massachusetts, Washington, Canada and Germany. AMGN operates manufacturing facilities in California, Colorado, Rhode Island, Washington and Puerto Rico. It markets its products to healthcare providers including physicians or their clinics, dialysis centers, hospitals and pharmacies primarily in the United States, Europe, Canada and Australia. The Company was founded in 1980 and is based in Thousand Oaks, California.

A strong track record of revenues

The Company’s revenue has almost doubled in the last six years, going from $7.9 billion in 2003 to approxi-mately $15.1 billion in 2008. AMGN earns approximately 97% of revenues from the sales of human therapeutic products. For 2007 and 2008, AMGN reported a modest growth of product sales due to a drop in the sales of Aranesp, AMGN’s flagship anemia drug. However, the decline in Aranesp was offset by a greater demand for ENBREL and Neulasta®/NEUPOGEN. International product sales in 2008 are likely to represent 22% of total product sales. In late December 2008, Reuters ranked the Company third among the top 10 best performers for the year in the S&P 500 index, in terms of percentage gains.

High profitability margins

AMGN is one of the most gainful companies in the industry in terms of profitability. AMGN’s gross and net margins remained strong over the last four quarters. The Company’s gross margin onQ3 2008 sales rang in at 82.5%. The slight decrease of the margin in third quarter of fiscal 2008 was primarily due to a decline in domestic

Highlights

Revenue, $ Mn

Source: SEC filings; Yahoo Finance;;

Page 3: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 3

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 3

demand for its flagship drug Aranesp, as well as pricing pressures.

Restructuring plan to improve the cost structure

In the second half of 2007, AMGN announced a plan to restructure its worldwide operations in order to improve the cost structure while continuing to make significant R&D investments, and to build the framework for the fu-ture growth. Through September 30, 2008, the Company has completed a majority of the actions initially included in the restructuring plan: (i) worldwide staff reductions aggregating approximately 2,500 positions, (ii) ratio-nalization of worldwide network of manufacturing facilities in order to gain cost efficiencies, while continuing to meet future commercial and clinical demand for its products and product candidates and, to a lesser degree, changes to certain R&D capital projects and (iii) abandoning leases primarily for certain R&D facilities that will not be used in its operations. Through September 30, 2008, AMGN incurred a total cost with respect to these ac-tions of $790 million. The total cost of restructuring program was projected to near $925 million. Solid balance sheet and operating cash flow

As of September 30, 2008, the Company has a strong balance sheet, with approximately $9.8 billion in cash, cash equivalents and short-term investments. The Company also reported significant cash flows from operations that neared $4.5 billion for the first nine months of 2008.

2009

Gross Margin, %

Source: SEC filings;

Page 4: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 4

Despite the financial crisis, the Company, due to its conservative investment portfolio, does not have exposure to subprime mortgages and other risky investments.

Heavy investments in R&D to support a solid pipeline of drug candidates

For about 30 years, the Company has been an innovator in the identification, isolation, production and use of human proteins as therapeutic agents. In building its pipeline, AMGN focuses on products with significant differentiation from existing drugs and delivers a number of innovative products that provide important treat-ments for patients around the world. In addition to internal R&D efforts, AMGN acquires companies, acquires and licenses certain product and technology rights and establishes R&D collaborations.

The Company follows a large, sustained and smart R&D investment strategy. Each year AMGN tries to invest on the order of 20% of its revenues in research and development. Since 2001, the Company has invested more than $17 billion to expand its R&D capabilities; its R&D pipeline has more than doubled.

In 2001, the Company had two blockbuster products and today it has five blockbusters on the market. Over the next five years AMGN plans to have three more drugs, which could achieve blockbuster status. In addition, the Company is anticipating 17 key phase 2 and 3 clinical study results in 2009 and 2010, including for denosumab (oncology), AMG 386 and AMG 655 for various cancer indications, and its Sensipar/Mimpara EVOLVE trial, an outcomes study in dialysis patients.

Denosumab the next blockbuster drug for AMGN

In July 2008, the Company reported that its new drug – Denosumab, the first fully human monoclonal antibody, which significantly reduces the risk of bone fracture in post-menopausal women, had passed the FDA phase 3 trials. AMGN seeks Denosumab’s approval for two purposes: treatment and prevention of osteoporosis in post-menopausal women; and prevention and treatment of osteoporosis in breast cancer and in prostate cancer patients who have had hormone therapy.

AMGN submitted its Biological License Application for Denosumab to the FDA on December 19, 2008. If all goes well, the company could begin marketing Denosumab by the end of 2009. The drug is set to become a

Selected balance sheet data, $ Bn

Source : SEC Filings.

Total Assets, includingCash and cash equivalents

Liabilities, includingDebtEquity

34.67.2

16.811.217.9

37.09.8

17.211.219.8

31-Dec-07 30-Sep-08

Page 5: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 5

blockbuster and is seen as AMGN’s biggest growth driver over the next five years, with sales forecast to range from of $1.5 billion to $3 billion by 2012.

Aranesp sales in the U.S. are set to decline due to significantly restricted Medicare reimbursement for use of Aranesp

The launch of Aranesp for the treatment of chemotherapy-induced anemia was in the mid-year 2002. Already in 2003, worldwide Aranesp sales were $1.5 billion. The sales of the drug peaked in 2006 when sales of more than $4.1 billion were reported, representing 30% of the Company’s total revenues.

However, since 2007, AMGN is experiencing a decrease in the Aranesp sales, driven mainly by the U.S. regulatory and reimbursement developments, as well as specific events, including a slight decline in share, price pressures, new oncology label/REMS, contract changes and the development of biosimilars (Europe). The Company is ex-pecting an additional decline of 10%-20% in Aranesp sales before a longer-term stability is achieved in 2009.

Favorable industry outlook

The biotechnology industry has been an engine of innovation for the U.S. healthcare system and, more generally, the U.S. economy. The biotechnology industry has expanded rapidly since 1992, with revenues increasing from $8 billion in 1992 to more than $60 billion presently. It is one of the most research-intensive industries in the world, spending in 2006 more than $20 billion. Within the biotechnology market, oncology will continue to be an area of prime focus for many organizations, with strong product lines as well as strong pipelines.

AMGN is a leading human therapeutics company in the biotechnology industry, which has pioneered the scientific discovery and innovation to advance the practice of medicine for more than 25 years.

Despite the recent problems such as clinical trial setbacks and safety con-cerns surrounding its Aranesp and Epogen drugs, the Company is recov-ering with investment in R&D that more than double the size of AMGN’s pipeline. In addition, the Company is likely to weather the current finan-cial storm and, moreover, it expects to take advantage of the current finan-cial crisis that will cause hundreds of small biotechnology companies to turn to their larger counterparts in coming months.

The Company’s future growth driver is expected to be Denosumab, which is estimated by analysts to have peak yearly sales in the range of $1 billion to $2 billion. Thus, if Denosumab will be a runaway success, AMGN is poised to be among the top companies in terms of revenue and earnings growth in the industry over the next five years.

Despite the many macro in the market, the big biotechnology companies have solid positions and are poised to improve their pipelines of drug candidates since the smaller research companies are facing liquidity issues. AMGN is currently trading at 12.48x times 2009 EPS consensus estimate, which is in line with the peer group median. However, we expect AMGN to trade closer Genetech (DNA) multiples given the future sales potential of Denosumab.

Investment sentiment

Page 6: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 6

Taking in consideration the solid results reported for the last years, the favourable outlook for the biotechnology market and the blockbuster potential of Denosumab, we rate AMGN as a “Buy.”

Comparative analysis

Source : Yahoo Finance

Genentech Inc. Bristol-Myers Squibb Co. Merck & Co. Inc. GlaxoSmithKline plcMedian Amgen Inc.

DNABMYMRKGSK

AMGN

84.7422.4929.2438.84

58.42

89,150 44,520 61,780 99,230

61,890

24.7113.318.86

10.8512.08

12.84

21.5611.428.94

10.8511.13

12.48

6.66 2.14 2.59 2.85 2.72

4.11

6.17 2.01 2.57 2.86 2.71

4.01

2008Company Name5-Jan-09

Tickersymbol

Price per

Share,$

Mrkt. Cap.$ Mn 2009 2008 2009

P/E P/S

Page 7: Analyst: Victor Sula, Ph.D. Initial Report January

Analyst: Victor Sula, Ph.D.Initial Report

January 9th, 2008

Amgen Inc. (NASDAQ: AMGN) 7

Disclaimer

DO NOT BASE ANY INVESTMENT DECISION UPON ANY MATERIALS FOUND ON THIS REPORT. We are not registered as a securities broker-dealer or an investment adviser either with the U.S. Securities and Exchange Commission (the “SEC”) or with any state securities regulatory authority. We are neither licensed nor qualified to provide investment advice.

The information contained in our report should be viewed as commercial advertisement and is not intended to be investment advice. The report is not provided to any particular individual with a view toward their individual circumstances. The information contained in our report is not an offer to buy or sell securities. We distribute opinions, comments and information free of charge exclusively to individuals who wish to receive them.

Our newsletter and website have been prepared for informational purposes only and are not intended to be used as a complete source of information on any particular company. An individual should never invest in the securities of any of the companies profiled based solely on information contained in our report. Individuals should assume that all information contained in the report about profiled companies is not trustworthy unless verified by their own independent research.

Any individual who chooses to invest in any securities should do so with caution. Investing in securities is speculative and carries a high degree of risk; you may lose some or all of the money that is invested. Always research your own investments and consult with a registered investment advisor or licensed stock broker before investing.

Information contained in our report will contain “forward looking statements” as defined under Section 27A of the Securities Act of 1933 and Section 21B of the Securities Exchange Act of 1934. Subscribers are cautioned not to place undue reliance upon these forward looking statements. These forward looking state-ments are subject to a number of known and unknown risks and uncertainties outside of our control that could cause actual operations or results to differ ma-terially from those anticipated. Factors that could affect performance include, but are not limited to, those factors that are discussed in each profiled company’s most recent reports or registration statements filed with the SEC. You should consider these factors in evaluating the forward looking statements included in the report and not place undue reliance upon such statements.

We are committed to providing factual information on the companies that are profiled. However, we do not provide any assurance as to the accuracy or com-pleteness of the information provided, including information regarding a profiled company’s plans or ability to effect any planned or proposed actions. We have no first-hand knowledge of any profiled company’s operations and therefore cannot comment on their capabilities, intent, resources, nor experience and we make no attempt to do so. Statistical information, dollar amounts, and market size data was provided by the subject company and related sources which we believe to be reliable.

To the fullest extent of the law, we will not be liable to any person or entity for the quality, accuracy, completeness, reliability, or timeliness of the information provided in the report, or for any direct, indirect, consequential, incidental, special or punitive damages that may arise out of the use of information we provide to any person or entity (including, but not limited to, lost profits, loss of opportunities, trading losses, and damages that may result from any inaccuracy or incompleteness of this information).

We encourage you to invest carefully and read investment information available at the websites of the SEC at http://www.sec.gov and FINRA at http://www.finra.org.

All decisions are made solely by the analyst and independent of outside parties or influence.

I, Victor Sula, Ph.D, the author of this report, certify that the material and views presented herein represent my personal opinion regarding the content and securities included in this report. In no way has my opinion been influenced by outside parties, nor has my compensation been either directly or indirectly tied to the performance of any security listed. I certify that I do not currently own, nor will own and shares or securities in any of the companies featured in this report.

Victor Sula, Ph.D. - Senior Analyst

Victor Sula, Ph.D. has held the position of Senior Analyst with several independent investment research firms since 2004. Prior to 2004, Mr. Sula held Senior Financial Consultant positions within the World Bank sponsored Agency for Restructuring and Enterprise Assistance and TACIS sponsored Center for Produc-tivity and Competitiveness of Moldova, where he was involved in corporate reorganization and liquidation. He is also employed as Associate Professor at the Academy of Economic Studies of Moldova. Mr. Sula earned his Ph.D. degree in 2001 and bachelor’s degree in Finance in 1997 from the Academy of Economic Studies of Moldova. Mr. Sula is currently a level III candidate in the CFA program.