THE BULL MARKET BIOTECH INVESTOR for Wednesday, July 11, 2001
From the Hot Biotech board!
http://www.investorshub.com/boards/board.asp?board_id=561
The Bull Market Biotech Investor - http://www.BullMarket.com
THE BULL MARKET BIOTECH INVESTOR for Wednesday, July 11, 2001
Volume 20, #1
http://www.BullMarket.com
The Bull Market Biotech Investor is a bi-weekly series of discussions of the changing Biotech and Pharmaceutical world we live in and the companies that are going to profit from these changes.
The Bull Market Report web site has links to The Bull Market Biotech Investor (http://www.BullMarket.com). The site includes The Bull Market Biotech Portfolio (with 12-month price targets for our 19 stocks), and all issues of The Bull Market Biotech Investor, including today's. Descriptions of the companies and links to their web sites accompany the Portfolio. We cover the most relevant news relating to investment potential in the
healthcare industry, and particularly to the companies in our
Portfolio. Just because we haven't mentioned an event or a company doesn't mean we don't think it's important!
(Note: All prices below are current as of Wednesday's close, with percentage changes from last Wednesday.)
IN THIS ISSUE
1. COMMENTARY
2. NEWS IN THE BIOTECH SECTOR
3. BEST PERFORMERS IN 2Q
4. PORTFOLIO-SPECIFIC NEWS
5. PORTFOLIO TRACKER
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1. COMMENTARY
U.S. stocks have been showing a bit of strength during early morning trading sessions, but have not been able to hold those gains late in the day. The practice of “buy on the dips” has turned into a “wait and see” approach. This week, stocks have fallen to new three-month lows, as investors have grown concerned over upcoming quarterly earnings. As the earnings season begins, investors are preparing for a few hundred
financial reports this week and well over one-thousand next week. Several months ago, many investors, analysts and high-tech corporate executives were predicting that the economic downturn would end in the second half of this year. However, that no longer seems to be the case, as many firms have offered multiple revisions to future earnings and business forecasts.
Based on the data we’ve seen so far, it looks as though conditions apparently will not improve this year. The Biotech sector has taken its own hits the past few weeks.
Equipment suppliers such as Applied Biosystems (ABI, $23, down 12%), Waters Corp. (WAT, $24, down 10%) and Affymetrix (AFFX, $19, down 11%) have warned of declining sales and earnings going forward. In addition, Amgen (AMGN,
$57, down 6%) and Genentech (DNA, $43, down 26%) have both come up short in satisfying the FDA with drug applications and clinical data. The FDA recently judged as inadequate Amgen and Praecis Pharmaceuticals’ (PRCS, $12, down 14%) drug application for Plenaxis (to treat prostate cancer). Also, the FDA delayed approval for Genentech’s Xolair, an antibody to treat asthma and allergy.
Fortunately, not all of the news from the FDA has been bad. On Tuesday, Scios (SCIO, $21, down 4%) received an approval
letter from the FDA for the company’s Natrecor drug, which treats
congestive heart failure. Details with respect to drug labeling and approval of the manufacturing facility still need to be completed, but it appears as though Scios is now on its way to marketing a significant drug.
One group that is expected to provide consistent earnings growth is the large drug firms, including the generic drug manufacturers. The world’s largest drug maker, Pfizer (PFE, $39, down 4%), is expected to show 25% earnings per share growth over last year. Earnings are being driven by sales of its cholesterol drug Lipitor and cost savings associated with
the Warner-Lambert merger. Pfizer was downgraded on Wednesday after one analyst noted a recent decline in prescriptions for Pfizer’s drugs Zoloft, Norvasc and Lipitor. However, any weakness in sales seems to be pretty much priced into the stock.
Eli Lilly (LLY, $76, down 1%) is also expected to grow its earnings by 20% this quarter. However, Lilly faces the expiration of its patent in August on the antidepressant Prozac. Thus, its earnings are projected to decline
over the next four quarters. The decline in Prozac sales will
hopefully be offset by Xigris (formerly Zovant), Lilly’s anti-sepsis drug that the FDA is currently reviewing.
One company that is slated to sell its generic version of Prozac is Barr Laboratories (BRL, $66, down 6%). Barr announced on Wednesday that despite slowing sales of Tamoxifen (to treat breast cancer), improving sales among its other products will allow the company to beat earnings estimates by approximately 13%.
Other generic drug firms such as Taro Pharmaceuticals (TARO, $83, unch), Teva Pharmaceuticals (TEVA, $62, unch) and Ivax Corp. (IVX, $37, unch) have also been demonstrating solid
sales and earnings growth.
Late Wednesday, Genentech reported quarterly earnings that matched analysts’ estimates of 19 cents per share. Yet while the company recognized very solid annual growth in Rituxan and Herceptin sales, the sales figures came in about $10 million shy of expectations. Rituxan sales grew 83% to $188 million and Herceptin sales improved to $79 million. Genentech shares further declined about 5% during after-hours trading.
On a related note, IDEC Pharmaceuticals (IDPH, $61, down 10%)
stated that its quarterly earnings would come in at 15 cents, in-line with estimates. Unfortunately, in these market conditions, meeting estimates is not good enough for high PE stocks, and IDEC shares were trading down to $48 in the after-hours session.
Presented below are some of the companies (and their earnings
estimates) that are expected to release earnings in the coming week:
Thurs. 7/12
Abbott Labs ABT 0.45
Mon. 7/16
Diversa DVSA -0.11
Tues. 7/17
ArQule ARQL -0.16
Biogen BGEN 0.46
COR Therap CORR 0.05
Forest Labs FRX 0.36
Pfizer PFE 0.29
Wed. 7/18
Immunex IMNX 0.06
Millennium Ph MLNM -0.16
Thurs. 7/19
Dyax Corp. DYAX -0.23
Genzyme GENZ 0.28
Eli Lilly LLY 0.74
IDEC Pharma IDPH 0.15
Incyte Genom INCY -0.21
Molecular Dev MDCC 0.15
Rosetta Inph RSTA –0.31
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2. NEWS IN THE BIOTECH SECTOR
Scios (SCIO, $21, down 4%) announced that it has received a letter from the U.S. FDA stating that the company’s New Drug Application for Natrecor is approvable. To finalize the approval process, Scios and the FDA need to define the labeling for Natrecor and complete a pre-approval inspection. Scios has developed Natrecor as an intravenous treatment for patients with acutely decompensated congestive heart failure (CHF). The company expects to launch the drug in the third quarter of this year.
Natrecor is a recombinant form of B-type natriuretic peptide -- a
naturally occurring hormone in the body that aids in the healthy
functioning of the heart. When approved by the FDA, Natrecor will become the first new treatment for acutely decompensated CHF in more than a decade. Roughly five million Americans suffer from heart failure, with 550,000 new cases diagnosed each year. There are approximately one million hospitalizations each year in the United States due to acute CHF.
For the second time in four months, Applied Biosystems (ABI, $23, down 12%) has warned of slowing revenue growth. The company, which makes genetic research equipment, projected a 12% decline in sales of its instruments. Applied Biosystems said it expects to post revenues for the fourth quarter ended June 30 of about $405 million, or below the $430 million projected by analysts. In March, Applied Biosystems projected revenue growth between 10-13% over the next few quarters, well below its
long-term growth target of 20%.
Barr Laboratories (BRL, $66, down 6%) raised its fiscal fourth-quarter earnings forecast to 49-50 cents from 43 cents. The company stated that sluggish sales of breast cancer drug Tamoxifen were more than offset by sales of other high-margin products. Barr, which specializes in the marketing of generic forms of brand-name drugs, particularly women's health-care products, had reported lower-than-expected fiscal third-quarter sales of Tamoxifen. Yet with sales of $90 million in the
quarter ended March 31, the drug still accounted for about 65% of the firm’s total revenues. However, Barr beat analysts’ estimates on sales of other drugs, such as clot buster Warfarin. The company is expected to enhance earnings later this year when it begins marketing a generic form of Eli Lilly’s (LLY, $76, down 1%) antidepressant, Prozac.
DeCODE Genetics (DCGN, $8, down 17%) extended its diagnostic collaboration with Swiss healthcare group Roche Holding in a deal that may be worth as much as $300 million. The five-year agreement, which covers the development and marketing of DNA-based diagnostic tests for major diseases, was first announced in March, but financial details were only
revealed after the two firms signed a number of definitive terms last week. The agreement extends an earlier collaboration between the two firms, worth up to $200 million, to develop new drugs using deCODE's genomic technologies. DeCODE has so far delivered three drug targets for schizophrenia, stroke and narrowed arteries under that deal.
DeCODE is attempting to develop diagnostics and discover
disease-related genes by analyzing the genetic composition of Iceland’s population. Under the deal, deCODE will receive some $15 million a year in fixed funding, including an upfront fee of $5 million, plus a royalty on sales of products that eventually come to market. The first DNA diagnostic product is expected to be available by the end of next year.
Abgenix (ABGX, $34, down 22%) received a milestone payment from Amgen (AMGN, $57, down 6%) due to the advancement into clinical trials of a fully human antibody therapeutic made with Abgenix’ technology. In April 1999, Amgen and Abgenix established a five-year collaboration to develop monoclonal antibodies against undisclosed antigen targets, which were
supplied by Amgen. Under the terms of that deal, Abgenix not only receives upfront research payments, but could also receive license fees, milestone payments and royalties on any future product sales by Amgen. Amgen is responsible for product development, manufacturing and marketing of any products developed through the collaboration.
Sequenom (SQNM, $12, down 1%) announced the sale of five MassArray systems, increasing the company's total number of system sales for the second quarter to nine. The MassArray system is used to analyze genes to determine their association to disease and to accelerate genetics-based diagnostics and drug development. Sequenom has identified 50 candidate disease genes and plans to enter into licensing deals and partnerships for
many of these genes. However, with the company’s pending acquisition of Gemini Genomics, Sequenom has positioned itself to internally develop some of the most interesting targets into marketable drugs.
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3. BEST PERFORMERS IN 2Q
Although Biotech stocks have experienced a rough start in the
second-half of 2001, the Biotech sector was one of the best areas to be invested in the second quarter. During that time, the Amex Biotech index (BTK) advanced 30% while the Nasdaq Composite and S&P 500 index increased 17% and 6%, respectively. Of course, the Biotech sector began a steep
decline in early February that ended about March 22. Thus, Biotech stocks were deeply oversold to begin 2Q, and thus were primed to gain some ground.
Approximately one-third of Biotech stocks advanced 50% or more during 2Q, so it’s no wonder that these stocks have encountered some selling pressure in the past few weeks. Presented below are some of the best-performing stocks for the second quarter. For each security, we list last quarter’s closing price (Close), the point change (Chg.) and the percent change (%Chg.). Use the courier font to view the list.
Close Chg. %Chg.
StemCells STEM 5 3 170
Genome Therapeutic GENE 15 9 147
Dendreon DNDN 17 10 141
XOMA Ltd. XOMA 17 10 137
Genta GNTA 13 7 125
Immunomedics IMMU 21 12 122
Exelixis EXEL 19 10 118
Dyax Corp. DYAX 17 9 118
Enzo Biochem ENZ 34 17 102
ILEX Oncology ILXO 30 15 96
Protein Design Lab PDLI 87 42 95
Lexicon Genetics LEXG 12 6 90
Abgenix ABGX 45 21 90
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4. PORTFOLIO-SPECIFIC NEWS
AMGEN’S (AMGN, $57, down 6%) initial target of getting Aranesp approved in the first half of 2001 has now passed. U.S. regulators continue to review the drug application. According to the company, discussions persist with respect to the drug’s labeling, but there have not been any requests for additional clinical data. Aranesp is a longer-lasting version of Epogen,
which is used to treat anemia and has already been approved for use in the European Union and Australia.
For investors, the concern is that continued delays in the approval process will thwart the company’s earnings growth. Last April, Amgen lowered its earnings growth projections for 2001 to the low-double-digit range due to a slower-than-expected regulatory review. The company currently markets Epogen in the U.S. for the kidney dialysis market while Johnson & Johnson (JNJ, $53, up 5%) is licensed to conduct overseas sales, which it does under the brand name Procrit. Approval for Aranesp is
significant because Amgen has retained all marketing rights to the drug.
CELERA GENOMICS (CRA, $32, down 20%) registered the Netherlands Research Council for access to its gene database information. The Netherlands Organization for Scientific Research is the largest national sponsor of fundamental scientific research at thirteen Dutch universities and fifteen
other academic research institutes. The Celera Discovery System is an integrated, web-based platform that enables users to leverage Celera's computational tools, super-computing power, and genomic and biological data to advance the discovery process for researchers worldwide.
Celera also announced that it has formulated an agreement with the National Cancer Institute (NCI), of the National Institutes of Health (NIH), that allows NCI principal investigators to independently choose whether or not to register for Celera’s database information. Although this agreement will not bring a windfall of revenues to Celera, it validates the strength of Celera’s annotated database in comparison to the public database developed by the Human Genome Project and funded by the NIH.
Shares of GENENTECH (DNA, $43, down 26%) took a nosedive yesterday after the U.S. FDA delayed approval for the company's asthma drug Xolair. U.S. regulators have requested additional preclinical and clinical data analyses from Genentech, which will require the company to resubmit its drug application.
Approval for Xolair was expected to occur early next year, but now will likely be delayed until 2003. Genentech is co-developing the drug with Novartis (NVS, $33, down 1%) and Tanox (TNOX, $14, down 52%), the drug's creator. Tanox shares dropped 44% yesterday on the news. Novartis and Genentech tested 1,950 patients in its Phase III trials, yet the FDA is concerned that not enough patients were tested. Therefore, they cannot determine whether or not the drug is safe based on the limited
clinical data that it currently has. It is unclear whether or not the FDA will require additional clinical trials. However, the good news is that the companies have a stable of data from both ongoing and completed trials that has not yet been submitted. For investors, the big concern here is the impact that Xolair's delay will have on Genentech's earnings growth
rate. The company is scheduled to release its quarterly earnings report tomorrow after the market closes, so we should learn a little bit more at that time.
PsychoGenics, a Biotechnology company engaged in neurological and behavioral research, initiated an agreement with GENE LOGIC (GLGC, $18, down 12%) to receive customized gene expression information relevant to central nervous system tissue samples.
For the past several years, HUMAN GENOME SCIENCES (HGSI, $48, down 16%) has participated in a drug discovery collaboration by providing access to its genetic database to a group of five large Pharmaceutical firms, including GlaxoSmithKline (GSK, $56, unch), Takeda, Merck KGaA, Sanofi-Synthelabo and Schering-Plough (SGP, $36, unch). The initial research term for the collaboration expired at the end of June, leaving Human Genome free to establish new drug discovery agreements with more
favorable revenue retention and profit-sharing terms. Those firms that participated in the consortium will be able to pursue the projects they have initiated, but will not be able to begin any new projects using Human Genome’s technology.
Human Genome’s management affirmed that only a small portion of the 90,000 human genes that the company has identified have been pursued by consortium members. Collectively, the members are actively pursuing approximately 430 research projects involving roughly 280 different genes for the creation of small molecule and antibody drugs. If any of these programs result in commercialized drugs, Human Genome will be entitled to certain milestone and royalty payments. In addition, for drugs developed
by GlaxoSmithKline, Human Genome will be entitled to certain
co-promotion rights.
There has been some debate as to the productivity of the human gene therapeutic consortium and the value of Human Genome’s genetic database. Some analysts expected the consortium to pursue many more gene targets (about 500) and also wondered why more drug candidates had not been moved into clinical trials. To date, only GlaxoSmithKline, the company's oldest partner, has pushed a drug candidate from the database into early human
testing. However, the number of gene targets that are being pursued is not so important as long as the quality of those targets is high. If the firms participating in the consortium have gone to great lengths to characterize their chosen genes and the proteins they make, then it makes sense that these companies have focused on fewer genes with better prospects for succeeding in clinical trials.
IMCLONE SYSTEMS (IMCL, $43, down 16%) filed an application with the FDA to market IMC-C225 in combination with irinotecan (a chemotherapeutic agent) to treat refractory colorectal cancers that over express the epidermal growth factor receptor (EGFR). IMC-C225 is a monoclonal antibody that binds to and blocks the activity of EGFRs, which are expressed on the surface of many cancer cell types. Early this year, the FDA designated IMC-C225 with the “fast track” status for the treatment of irinotecan-refractory colorectal cancer. Fast Track designation means that the FDA will facilitate the development and expedite the review of a drug if it is intended for the treatment of a serious or life-threatening condition, and it demonstrates the potential to address unmet medical
needs for such a condition.
ImClone Systems is studying IMC-C225 in a series of Phase II and Phase III clinical trials. The company is conducting Phase II clinical studies of IMC-C225 in combination with standard therapies in patients with various stages of colorectal cancer, pancreatic cancer, head and neck cancer, and non-small cell lung cancer. In addition to the Phase II studies, the Company is conducting a Phase III clinical trial combining IMC-C225 with
chemotherapy and another study combining IMC-C225 with radiotherapy as first-line treatments for head and neck cancer.
In an action that may squeeze the breath out of The Immune Response Corp. (IMNR, $2, down 52%), PFIZER (PFE, $39, down 4%) terminated its support to further develop Remune, an experimental anti-AIDS drug being developed by Immune Response. Shares of Immune Response declined 44% on the news to close at $2.58. Pfizer dropped the drug following disappointing clinical
trial results.
Pfizer became involved with Remune through Agouron Pharmaceuticals, which established a collaboration with Immune Response. Warner-Lambert acquired Agouron Pharmaceuticals and Pfizer later acquired Warner-Lambert. Immune Response holds enough cash to operate for the remainder of this year, but
decided several months ago to stop research efforts in other areas and focus exclusively on Remune.
VIROPHARMA (VPHM, $26, down 17%) filed plans with the Securities and Exchange Commission to periodically sell up to $300 million of its common and preferred stock, debt securities and warrants. The company stated in the filing that net proceeds will be added to its general funds for general corporate purposes, which may include: marketing and research
for its drug Picovir (for the treatment of viral respiratory infection, or the common cold) and research for its hepatitis C and RSV disease product candidates, potential acquisitions, capital expenditures, debt retirement and general working capital.
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5. PORTFOLIO TRACKER
THE BULL MARKET BIOTECH INVESTOR PORTFOLIO
The columns indicate the closing price of stocks on July 11th, the percent change over the past five trading sessions (%Chg.) and the year-to-date percent change (%YTD). The table should be viewed with the courier font.
Close %Chg %YTD
Affymetrix AFFX 19 -11 -74
Amgen AMGN 57 -6 -11
Biomira BIOM 7 -2 26
Celera Genomics CRA 32 -20 -12
COR Therapeutics CORR 28 -8 -19
Gene Logic GLGC 18 -12 -1
Genentech DNA 43 -26 -48
Gilead Sciences GILD 53 -9 28
Human Genome Sciences HGSI 48 -16 6
ImClone Systems IMCL 43 -16 -3
ImmunoGen IMGN 15 -22 -18
Maxygen MAXY 17 -11 -31
Medarex MEDX 20 -17 -10
MedImmune MEDI 43 -8 -10
Millennium Phrmaceutcl MLNM 29 -15 -53
Merck MRK 62 -4 -33
Pfizer PFE 39 -4 -15
Pharmaceutical HOLDR PPH 96 -1 -16
ViroPharma VPHM 26 -17 79
Average Portfolio Return -7 -20
The S&P 500 -4 -11
The Nasdaq Composite -8 -20
The Amex Biotech Index -13 -17
Biotech HOLDRS -12 -31
Robert Mendoza, Ph.D.
Editor
The Bull Market Biotech Investor
Mendoza@BullMarket.com
Good Biotech investing!
Todd Shaver
Editor in Chief
The Bull Market Report
Washington, DC USA
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