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#2 Genentech


1 DNA Way
South San Francisco, CA 94080
Tel: (650) 225-1000
Fax: (650) 225-6000
www.gene.com


Headcount 9,563  
Year Established 1976  
Biopharma Revenues $5,488  +46%
Total Revenues $6,633 +44%
Royalty Revenues $935 +46%
Net Income $1,279 +63%
R&D Budget $1,262 +33%

Drugs Approved/Launched
Drug Indication 
tarceva
pancreatic cancer
avastin with 5-FU-based chemotherapy second-line metastatic colorectal cancer
lucentis
wet age-related macular degeneration

Drugs Pending Approval
Drug Indication
herceptin
adjuvant HER2+ breast cancer
avastin first-line metastatic breast cancer, first-line non-squamous non-small cell lung  cancer, relapsed metastatic colorectal cancer, second-line metastatic colorectal cancer in combination with intravenous 5-FU-based chemotherapy
rituxan indolent frontline NHL, rheumatoid arthritis

Drugs in Phase IIb and Beyond
Drug Indication
avastin breast, colon, NSCLC, rectal, breast, prostate,
pancreatic and ovarian cancer, gastrointestinal stromal tumors
rituxan relapsed chronic lymphocytic leukemia, ANCA-associated vasculitis,
lupus nephritis, multiple sclerosis, lupus erythematosus
tarceva adjuvant and first-line NSCLC
xolair
pediatric asthma

Early Research Projects
Drug Indication
apo2L/TRAIL oncology
br3-fc
rheumatoid arthritis
topical hedgehog antagonist
basal cell carcinoma
trastuzumab-dm1 her2+ metastatic breast cancer
anti-br3
chronic lymphocytic leukemia

Top Selling Drugs
Drug Indication
Sales
(+/-%)
rituxan leukemia, lymphoma,
rheumatoid arthritis
$1,831 +16%
avastin colorectal cancer $1,133 +108%
herceptin breast cancer $747 +56%
nutropin/protropin growth hormone $370 +6%
xolair asthma $321 +71%
tarceva lung cancer $275 n/a
activase/TNKase thrombolytics $219 +13%
  
Account for 89% of total biopharma sales, same as in 2004.

PROFILE



If Genentech had huge success in 2005 as cancer drug Avastin doubled in sales to give the company its second billion-dollar seller. Breast cancer treatment Herceptin also posted significant gains in 2005, and was up more than 100% in 1Q2006 ($290 million), while lung cancer (and pancreatic cancer, after its November 2005 approval) drug Tarceva hit $275 million in its first full-year and nearly doubled its 1Q numbers in 2006 ($93 million).

In addition to the cancer franchise, the company's asthma drug Xolair (co-marketed with Novartis) brought in sales of $321 million in 2005, its second full year. Sales were up 46% in 1Q2006, to $95 million.

While Genentech's cancer drugs have had enormous success, another recent release has been struggling. Rapitva, which is marketed by Genentech, Xoma and Serono for the treatment of chronic plaque psoriasis, posted only $79 million in sales for Genentech (U.S. market). This was an increase of 51%, but the company admits that the boost was mainly due to a price increase instituted in April 2005. For 1Q2006, sales were up $4 million to $21 million. Genentech cited Amgen's Enbrel as a key competitor in the psoriasis field.

So they can't all be hits.

Meanwhile, the company's top seller, Rituxan, "only" posted 16% gains to $1.8 billion (U.S. sales only; European marketing is done by Genentech's owner, Roche). With Rituxan's recent approval to treat rheumatoid arthritis in patients who don't respond to anti-TNF therapies, expect Genentech's lead product to stay in the lead for a while more.

Curiously, Rituxan saw a small boost in sales ($9.6 million) in 2005 because of a "reorder to replace a shipment that was destroyed while in transit to a wholesaler." Having received my share of damaged packages from Amazon, I can only imagine the aggravation on the receiving end of that delivery.

With new indications comes new demand, so, to ensure Rituxan's supply, Genentech worked to get Lonza Biologic's Portsmouth, NH facility approved to manufacture Rituxan's bulk substance. In December, the companies announced a long-term manufacturing agreement for the facility. The company also boosted its manufacturing base with the June 2005 acquisition of Biogen Idec's Oceanside, CA facility.

Hitting .600



In 1999, the company announced its "5x5" goals, a series of targets to be hit by 2005. Genentech accomplished three out of five:

  • 25% average annual earnings per share growth, non-GAAP: it reached 33% growth
  • five new products or indications approved: seven were cleared
  • five significant products in late-stage trials: the company says it has six products for 21 potential indications

The two 5x5 failures were:

  • $500 million in new revenues from alliances or acquisitions: the company only brought in $300 million
  • 25% net income as a percentage of operating revenues, non-GAAP: it reached 21%, which the company attributes to the success of Rituxan triggering a profit-sharing deal

A Sharp Stick in the Eye


Still, it's an awfully good track record for the #2 company on the Top Biopharma list. While much of Genentech's R&D is devoted to new indications for its oncology drugs, the company also found time to bring a non-cancer drug through its pipeline. In December 2005, the company submitted a BLA for Lucentis, a treatment for wet age-related macular degeneration. In February 2006, the FDA granted Lucentis priority review status, and the drug received approval in July 2006.

In January 2006, the company presented data indicating that Lucentis beat Visudyne in a head-to-head study. In the "if you can't beat ‘em, join ‘em" category, it turns out that Visudyne's marketer, Novartis, owns non-North American rights to Lucentis. Novartis filed for EMEA approval of Lucentis in March 2006. Novartis posted $484 million in Visudyne sales in 2005, and there are estimates of Lucentis in the billion-dollar range. Not bad for a drug that is administered by a needle to the eye.

It looks like Lucentis is the only new drug in Genentech's late pipeline. The only product currently in Phase II or beyond is Omnitarg, an ovarian cancer treatment under co-development with Roche.

Under ordinary circumstances, I'd be wary of a company that is mainly investigating new indications for its existing lineup. However, given the youth of Genentech's roster, and the potential for multiple oncology blockbusters, Genen-tech is in an awfully good position at present (provided GlaxoSmithKline's Tykerb doesn't put a hit on Herceptin's long-term prospects).

In a recent BusinessWeek interview, chief executive officer Arthur Levinson was asked what makes Genentech "scared and worried" (his words, from an earlier analyst meeting) about the future. He replied:

Competitors are targeting us now. They've seen our success and they're going after a lot of our markets, including Avastin. We continue to invest in the science. We're trying to stay ahead of the competition by investing in mechanism-of-action studies. By understanding more about how the drug works in principal, we believe we can engineer it to work 10 times better. I want to make sure we're respectful of the competition and we don't get slack. We can't make mistakes.

That last sentence sums up the philosophy of every company on this Top 10 list.