David: BioTech Industry Dave: Amgen Christine: Genentech Karen: Protein Design Labs. BioTech. 2000 TV AD. 2004 TV AD. Definition. Sector: HealthCare Industry: Biotechnology & Drugs
Industry: Biotechnology & Drugs
Definition: engaged in the discovery, development, and commercialization of biotechnology based drugs and products (therapeutic proteins, recombinant DNA vaccines, gene therapies, and devices).
Protein Design Labs
Biotechnology first used to leaven bread and ferment beer, using yeast (Egypt).
1993 FDA approves bovine somatotropin (BST) for increased milk production in dairy cows.
1994 First FDA approval for a whole food produced through biotechnology: FLAVRSAVR™tomato.
1997First animal cloned from an adult cell: a sheep named Dolly in Scotland.
1998 A rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
1999 Biotechnology-based biopesticide approved for sale in the United States.
2001 Chinese National Hybrid researchers report developing a "super rice" that could produce double the yield of normal rice.
2002 The draft version of the complete map of the human genome is published.
2004 The FDA approves the first anti-angiogenic drug for cancer, Avastin (bevacizumab).
Look for companies with at least two drugs in clinical trials
Collaborative agreements with various pharmaceutical companies for research or marketing and link up with a corporate or academia partner => lower risk
Proven track record of taking a drug through the regulatory hurdles and/or to the marketplace
Company’s burning of cash in ongoing research and development or "burn rate" is a critical measure of a company’s longevity
Aimed at markets for a new drug that is both large and under-serviced.
Look to see if the research and development can do what it needs to do and supposedly solve a medical problem or problems.
Food andDrug Administration
To see the potential effects on humans
Processing of the NDA New Drug Application
Political & Legal:
Toward profitability by the end of the decade.
From potential to performance.
The future is bright.
a potentially life-changing discovery.
Mission Statement: “At Amgen, our mission is to serve patients. As a science-based, patient-focused organization, we will follow the science wherever it may lead, to discover and develop innovative therapies to treat grievous illness.”
Be Science BasedCompete Intensely and WinWork in Teams
Create Value for Patients, Staff and Stockholders
Trust and Respect Each OtherEnsure Quality
Collaborate, Communicate and Be AccountableBe Ethical
Kevin Sharer 56, CEO, has been a director since 1992 chairman of board since 2000, was COO and president from 92 to 2000, previously worked at MCI and GE – corporate guy, not a doctor
Dr. Hassan Dayem 58, Senior VP and CIO since 2002, previously with Merck
Dennis M. Fenton 53, Became Executive VP in 2000, has been w/ Amgen since 1988 and has o occupied various executive roles
Brian McNarnee 48, HR VP since 2001, previously with Dell Computer co
George Morrow 52, VP sales and marketing since 2001, previously with Glaxo
Richard Nanula 44, CFO since 2001 previously with broadband sports co.
Perlmutter 52, VP of R&D, previously held a senior position in R&D with Merck
David J. Scott 52, Senior VP General Counsel, since 2004, previously with Meditronic Inc.
Very good cash flow numbers
Strong balance sheet
Annual Revenue growth
Large customer base and volume of sales
Ambitious stock repurchase program
Small capital gains
Investors must have faith that Amgen will continue to grow
Generics will eventually pop up
Current Earnings could still be diminished if new side effects discovered
Declining profit marginPros and Cons
IN BUSINESS FOR LIFE
Founders Research Center
1976 Robert Swanson and Dr. Herbert Boyer who pioneered
the recombinant DNA technology, founded
Genentech on April 7th.
Robert Swanson Dr. Herbert Boyer (venture capitalist) (biochemist)
1980 Genentech went public and raised $35 million with an
offering that leapt from $35 a share to a high of $88 after
less than an hour on the market. The stocks traded on
NASDAQ under symbol GENE.
1988 Genentech stock begins trading on the NYSE under the
1990 Genentech and Roche Holding Ltd. Of Basel, Switzerland
completed a $2.1 billion merger.
1999 Genentech returned to the NYSE with a public reoffering of 22M
shares by Roche, in what is considered the largest public offering
in the history of the U.S. health care industry. The stock closed the
first day of trading at $127, over 31 percent above the public offering
price of $97. This was also the first introduction of Genentech's new
NYSE trading symbol, DNA.
1999 Roche conducted a secondary offering of 20 M Genentech
shares on October 20. The shares were priced at $143.50 per
share, making it the largest secondary offering in U.S. history.
“Our mission is to be the leading biotechnology company that discovers, develops, manufactures and market human pharmaceuticals for significant unmet medical needs. We commit ourselves to high standards of integrity in contributing to the best interests of patients, the medical profession, our employees and our communities, and to seeking significant returns to our stockholders, based on the continual pursuit of scientific and operational excellence.”
The 5X5 goals that outlined in 1999 and hopes to achieve by the end of 2005:
1.25 percent average annual non-GAAP EPS growth
EPS growth for 1999 through 2004 has been 29 percent.
2. 25 percent non GAAP net income as a percentage of operating revenues
For 2004, its non GAPP net income as a percentage of operating revenues was 19 percent. Given the success of Rituxan® (Rituximab) and the associated profit split, this financial productivity goal remains a significant challenge that will be difficult to meet.
3. 5 new products/indications approved
With the nine approvals of Nutropin Depot® [somatropin (rDNA origin) for injectable suspension], TNKase™ (Tenecteplase), Cathflo Activase® (Alteplase), Nutropin AQ Pen®, Xolair® (Omalizumab), RAPTIVA® (efalizumab), Avastin™ (bevacizumab), Tarceva™ (erlotinib), and Cathflo Activase for catheter clearance in pediatric patients, it has exceeded its 5X5 goal of five new products or indications approved by 2005.
4. 5 significant products in late-stage clinical trials
Its development pipeline has over 30 projects, with several projects in early stage and a steady flow of projects advancing in the pipeline.
5. $500 million in new revenues from strategic alliances or acquisitions
It has entered into more than 50 significant agreements and in-licensing arrangements since 1999, which position itself well for future growth prospects.
Chairman and Chief Executive Officer
President, Product Development
Executive VP, Commercial Operations
Senior Vice President, Finance
Executive VP, Research
Senior VP, Product Operations
Senior VP, Regulatory, Quality and Compliance
3. Vascular Medicine
Liquid formulation growth hormone
For GHD in children and adults; growth failure associated with chronic renal insufficiency (CRI) prior to kidney transplantation; short stature associated with Turner syndrome
Liquid formulation growth hormoneFor GHD in children and adults; growth failure associated with chronic renal insufficiency (CRI) prior to kidney transplantation; short stature associated with Turner syndrome
Inhalation SolutionFor management of cystic fibrosis (including patients under age 5)
$ In mils
Total revenues $ 4621.2
The significant licensed products, representing approximately 94% of
Genentech’s royalty revenues in 2004:
$ in Mils
Total Costs $ 3484.3 M
-0.071 0.143 0.061 0.53 0.73
$ in Mils
Shares Outstanding: 1.5 B
Below is the information regarding net income and earning per share has
been determined as if it had accounted for its employee stock options and
employee stock plan under the fair value method prescribed by FAS 123.
Max Link, Ph.D. 63
Chairman (joined in 1993)
Mark McDade, M.B.A. 48 $1.13M
Chief Executive Officer (joined in 2002)
Glen Y. Sato 44 Senior Vice President and Chief Financial Officer (joined in 1999)
Douglas O. Ebersole 48 $481KSenior Vice President Legal and Licensing and Secretary (joined 1992)
Steven E. Benner, M.D. 44 $773KSenior Vice President and Chief Medical Officer (joined in 1995)
Seven marketed drugs licensed under PDL:
I / II
Severe refractory ulcerative colitis
Prevention of renal allograft rejection following kidney transplantation
Moderate to severe persistent asthma
HuZAF™ (fontolizumab/ anti-gamma Interferon)
Moderate to severe Crohn’s disease
M200 (Anti-α5β1 integrin)
(Anti-α5β1 integrin Fab)
* Marketed as Zenapax® by Roche in kidney transplantation