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The Bull Market Biotech Investor

1. SUMMARY

Companies within the Biotech and Healthcare industries are delivering solid 2Q financial results. In the Biotech sector, the largest firms, mainly those with marketable products, have announced earnings that have exceeded analysts' estimates. GENENTECH (DNA, $78, down 1%), AMGEN (AMGN, $68, down 3%), GENZYME (GENZ, $49, up 4%), and INVITROGEN (IVGN, $54, up 10%) have given shareholders much to cheer about, as these firms continue to grow sales and earnings. Although GILEAD SCIENCES (GILD, $66, up 1%) has yet to report earnings, the firm stated that 2Q sales would exceed analysts' $180 million estimate by approximately $55 million. Sales of the anti-HIV drug Viread continue to drive profits for Gilead.

Of the large Biotech firms, BIOGEN (BGEN, $39, down 5%) is perhaps the most notable company that warned of lower earnings. However, the company did report pro forma earnings this week of 39 cents per share, the high-end of the lowered range (32 to 38 cents). Previously, analysts were looking for Biogen to earn 42 cents per share in the second quarter.

Biogen shares have traded lower since the announcement of the merger with IDEC PHARMACEUTICALS (IDPH, $34, down 5%). The merger has been perceived by many to bring few, if any, near-term rewards, and the drug pipelines of both firms aren't terribly robust. In fact, Biogen's most-advanced drug in development, Antegren, failed to achieve key endpoints in Phase III studies for Crohn's disease. While this result shouldn't impact the pending merger with IDEC, it certainly doesn't boost investor sentiment for these companies. Antegren, which is a collaborative effort with ELAN (ELN, $4.47, down 26%), is also in Phase III studies for the treatment of multiple sclerosis. Biogen currently sells Avonex to treat multiple sclerosis. Finally, IDEC Pharmaceuticals reported 2Q earnings that were in-line with estimates. While this firm's leading oncology drug Rituxan continues to achieve greater sales, its second drug Zevalin has yet to show much growth. In recent weeks, CORIXA'S (CRXA, $7.10, down 1%) Bexxar received FDA approval, which should give Zevalin some competition.

Both the Amex Biotech Index (BTK) and the Nasdaq Composite have made great gains since mid-March. With the earnings announcement period half-over, investors need additional good news to keep the momentum going for higher share prices. Unfortunately, with the tremendous stock gains in recent months, and the sector's high valuations, it appears that only those firms that are greatly exceeding earnings expectations are continuing to enjoy higher share prices. Therefore, the large-cap Biotechs, which are mainly represented in the BTK, need to come forth with further developments to maintain current price levels. Amgen and Genentech have been major contributors to the positive sentiment this year, and we expect that these stocks will continue to dictate further advances or declines. With investor sentiment high, we would not be surprised to see some weakness among Biotech stocks when the earnings period ends. Traditionally, the fourth quarter is quite positive for the Biotech sector, which is associated with significant scientific meetings and Biotech/Healthcare investment conferences.

A few companies achieving significant earnings in the previous quarter are worth noting. As mentioned above, INVITROGEN (IVGN, $54, up 10%) turned in a good quarter by reporting pro forma earnings of 56 cents per share, 4 cents ahead of estimates. This company is the leading manufacturer of molecular biology kits, enzymes, and reagents that the majority of academic and corporate labs use to perform molecular biology (primarily gene expression and gene cloning) experimentation. Other providers of laboratory equipment and supplies turned in decent quarters, although some of these stocks are now quite highly valued. PERKINELMER (PKI, $14, up 2%), WATERS (WAT, $30, up 3%), and AFFYMETRIX (AFFX, $23, up 9%) either met or exceeded earnings expectations. In general, the success of these firms suggests an increase in spending in the Biotech industry. In this group of companies, Invitrogen is certainly the leader, and is expected to outperform all others.

QLT Inc. (QLTI, $17, up 31%) stated on Monday that its partner Novartis (NVS, $39) announced record sales of Visudyne, an anti-blindness treatment, of nearly $90 million. On Wednesday, QLT reported earnings of 16 cents per share, 5 cents higher than estimates. The company, which halted Phase III trials of its Tariquidar lung cancer therapy in May, also raised pro forma earnings estimates for 2003 to a range of 50-60 cents per share.

Several companies showed an improvement in their financial results, despite posting a net operating loss. Since the share prices for many of these firms have increased in recent months, these companies now carry much risk. NEUROCRINE BIOSCIENCES (NBIX, $52, down 3%) and CV THERAPEUTICS (CVTX, $33, up 3%) each trimmed their quarterly losses. Both firms have experimental drugs at advanced stages of development, but these firms still are losing a lot of money. ILEX ONCOLOGY (ILXO, $18, down 3%) and SEPRACOR (SEPR, $23, up 20%) also trimmed their losses last quarter, but these firms with marketable products are not yet generating significant revenue. The ability of these stocks to maintain high valuations indicates that institutions continue to favor these securities.

Finally, one group of companies for investors to watch during this earnings period is the generic drug manufacturers. These firms continue to increase sales and earnings each quarter, and their growth rates support higher share prices. In March, we noted that many stocks in this sector were establishing new 52-week highs, and the prices today are higher (http://www.BullMarket.com/tdbi/032803.php3). The leading generic drug manufacturers include: TEVA PHARMACEUTICALS (TEVA, $54, down 4%), TARO PHARMACEUTICALS (TARO, $54, down 3%), BARR LABS (BRL, $62, down 2%), BIOVAIL (BVF, $42, unch.), and WATSON PHARMACEUTICALS (WPI, $40, up 1%). Taro Pharmaceuticals did report earnings this week, which came in one penny ahead of estimates.

2. PORTFOLIO-SPECIFIC NEWS

AMGEN REPORTS ROBUST SECOND QUARTER
Biotech giant AMGEN (AMGN, $68, down 3%) reported 2Q pro forma earnings of 49 cents per share, which surpassed analysts' average estimate of 46 cents. The pro forma number includes a four-cent gain relating to costs associated with last year's acquisition of Immunex. The company continues to experience sales growth across all product lines. As a result, the company lifted this year's per share earnings guidance to a range of $1.85-1.95 from $1.80-1.90. In addition, the projection for 2003 total product sales was increased to $8.0-8.5 billion from $7.7-8.2 billion. This is the second sequential quarter that Amgen has raised guidance for 2003 sales and earnings.

Amgen is experiencing robust sales in all therapeutic areas, but growth is particularly strong for Aranesp, a long-lasting version of the anti-anemia drug Epogen. Aranesp is indicated for the treatment of anemia in both kidney disease patients and patients receiving cancer chemotherapy. Worldwide Aranesp sales in the second quarter were $348 million. Over the past four quarters, Aranesp sales have reached $114 million (3Q02), $207 million (4Q02), $255 million (1Q03) and $348 million (2Q03). This year's sales estimate for the combined Aranesp and Epogen franchise was raised to a range of $3.7-3.9 billion from $3.4-3.6 billion. Aranesp continues to grab market share from JOHNSON & JOHNSON'S (JNJ, $52, down 1%) Procrit, which is essentially Epogen under license.

Combined worldwide sales of the infection-fighting drugs Neulasta and Neupogen reached $635 million, up from $540 million in the first quarter. Doctors continue to transition patients to Neulasta -- Amgen's once-per-cycle product for decreasing the risk of chemotherapy-related infections. Neupogen is used to decrease the incidence of infection during many types of cancer-related chemotherapy. Amgen increased its forecast for 2003 Neupogen and Neulasta sales to $2.4-2.6 billion from $2.3-2.5 billion.

Sales of the rheumatoid arthritis drug Enbrel were $305 million in the second quarter, a 10% improvement over the previous quarter. Amgen reaffirmed its 2003 sales guidance of $1.2-1.4 billion. Enbrel demand is now being met with Amgen's new Rhode Island facility; however, heightened demand may increase as Amgen tries to expand Enbrel label to the psoriasis market. Even though BIOGEN (BGEN, $39, down 5%) and ABBOTT (ABT, $40, down 5%) are already selling drugs to treat this disease, Amgen's clinical results suggest that Enbrel is quite effective.

Amgen continues to fire on all cylinders. We have been stating for over one year that the firm's second-generation drugs would push the Biotech giant into another growth phase. Finally, investors are once again migrating into the stock and the price is reaching new 52-week highs on a consistent basis. Amgen still represents one of the best long-term investments in the Biotech sector and the company's growth has not peaked. On a valuation basis, perhaps the greatest concern is the price-to-sales ratio. With Amgen's share price near $70, the market cap (share price multiplied by outstanding shares) of this firm is nearly $90 billion, thereby giving a trailing price-to-sales ratio near 14. This is a bit rich for a large drug firm, and something for investors to keep in mind, but fortunately Amgen's 30% growth rate is strong enough to support the valuation. If an investor considers Amgen's potential sales this year, then the forward price-to-sales ratio is closer to 11. This is not an unrealistic valuation for Amgen, but it does imply that much of this year's growth is priced into the stock. Nevertheless, the #1 Biotech firm is growing faster than most others.

AMGEN'S ENBREL TO ADDRESS PSORIASIS MARKET
AMGEN'S (AMGN, $68, down 3%) takeover of Immunex, and acquisition of the rheumatoid arthritis drug Enbrel, may soon bring the Biotech leader additional rewards. Amgen announced that it has submitted a drug application to the FDA for the use of Enbrel in the treatment of psoriasis. According to some analysts, the safety and efficacy data with Enbrel are significantly better than results observed with other drugs, namely BIOGEN'S (BGEN, $39, down 5%) Amevive.

Psoriasis is an inflammatory condition marked by red, scaly patches of skin. The disease affects approximately 7 million people in the US, including about 1.5 million with more severe forms of the disease. Sales of Enbrel totaled $802 million last year and Amgen projects 2003 sales of $1.2 billion-$1.4 billion.

ENBREL APPROVED TO TREAT ANKYLOSING SPONDYLITIS
The US FDA approved AMGEN'S (AMGN, $68, down 3%) arthritis drug Enbrel for the treatment of Ankylosing Spondylitis (AS). The approval comes only one month after the FDA's Arthritis Advisory Committee met to discuss the merits of the clinical data and drug application. AS is a painful, chronic, and progressive inflammatory disease affecting the spine and the joints and ligaments that normally allows a person's back to move and flex. Over time, new bone can develop and replace the elastic tissue of ligaments or tendons. Ankylosing Spondylitis affects about 350,000 people in the United States.

GENENTECH SHOWS STRONG EARNINGS
Three months ago, GENENTECH (DNA, $78, down 1%) failed to impress investors with its first-quarter financial report -- Rituxan sales fell short of expectations, and analysts again wondered whether sales had peaked for the world's leading oncology drug. Today, the earnings story has greatly improved, and the company is poised to enter another growth phase.

For the second quarter, Genentech reported pro forma net income of $165 million, or 31 cents per share, on $800 million revenue. The pro forma results exclude charges related to litigation expenses and the acquisition of Genentech shares by Roche in 1999. In comparison to the same period last year, net income improved 36% and total revenue increased 29%. Earnings beat analysts' estimates, which ranged between 23 and 29 cents per share.

Genentech's antibody-based drugs Rituxan (to treat non-Hodgkin's lymphoma) and Herceptin (to treat breast cancer) continue to drive revenue growth. Sales of Rituxan, which is a monoclonal antibody co-developed with IDEC PHARMACEUTICALS (IDPH, $34, down 5%), increased 32% to $365 million. Rituxan specifically binds to the CD20 protein on B cells and activates a series of molecular events leading to cell death. Herceptin sales improved 15% to $110 million. Herceptin is a humanized monoclonal antibody that is approved (in combination with Taxol) for the treatment of metastatic breast cancer. The drug is used in patients with tumor cells that over-express the Her2 protein. Sales of both oncology drugs exceeded Wall Street estimates of $360 million (Rituxan) and $100 million (Herceptin).

Genentech began this year with three major product goals, and two of these have been achieved. The company's asthma medication Xolair received FDA marketing approval in June and the firm released positive Phase III data on the experimental anticancer drug Avastin. Genentech's third goal addresses the FDA's review of the psoriasis drug Raptiva, which is expected to occur in the fourth quarter.

With respect to Avastin, Genentech aims to complete the drug application by the end of the third quarter. This will set up an FDA review by the end of March 2004. Avastin has received the FDA's Fast-Track designation, which gives the FDA six-months to review the application. Recently, Genentech established a partnership with Roche to market Avastin overseas. In addition, both companies will collaborate on applying Avastin to multiple tumor types (e.g. metastatic breast cancer, renal cell carcinoma and Non- Small Cell lung cancer). Avastin is an antibody designed to starve tumors of nutrients by disrupting the vascularization process: the growth of blood vessels in tumors.

Genentech executives expect earnings to grow at least 20% this year and revenue to reach $3 billion. While the share price already has doubled this year, primarily due to the encouraging clinical data with Avastin, money management firms continue to lift their opinions on the company and 12-month price targets. This is all good news, which should serve to support the share price. We have recommend that investors take some profit in this stock, but also maintain a position for further potential gains. Certainly, Genentech's achievements this year have positioned the firm for future growth.

GILEAD SHARES SOAR ON HIGHER DRUG SALES
GILEAD SCIENCES (GILD, $66, up 1%) announced last week that 2Q product sales approximated $236-239 million. Analysts' estimates were closer to $180 million. Gilead's anti-HIV drug Viread continues to experience heavy demand as a result of an increase in written prescriptions and wholesalers increasing inventory ahead of an anticipated price increase.

The second quarter represents Gilead's fifth consecutive quarter of positive earnings. For this year's first quarter, the company reported earnings of 24 cents per share on $165 million revenue. For the second quarter, Gilead should easily exceed analysts' average earnings estimate of 20 cents per share. 2Q earnings will be announced on July 31st.

GILEAD'S EMTRIVA RECEIVES FDA APPROVAL
The US FDA granted marketing approval to GILEAD SCIENCES' (GILD) Emtriva for the treatment of HIV infection. This milestone represents the firm's third anti-viral drug approval in two years. Emtriva (formerly Coviracil) inhibits HIV replication by blocking reverse transcriptase, an enzyme that functions to copy viral RNA (genetic material) into viral DNA. In this manner, the drug helps to lower the amount of HIV in a patient's body and increase the number of immune system cells.

Emtriva is Gilead's second anti-HIV drug to receive FDA approval. The company's Viread already is on the market. Viread has undergone many clinical studies to evaluate its long-term benefits and patient resistance. Both Emtriva and Viread are once-daily pills that are approved for use in combination with other anti-retroviral therapies. These drugs provide a tremendous benefit in reducing the number of pills that patients must take each day. Gilead is working on an Emtriva/Viread combination pill, which may reach the market in early 2005. An application for marketing approval of Emtriva was submitted to the European regulatory agency in December 2002. The Committee for Proprietary Medicinal Products of the European Medicines Evaluation Agency has recommended that Emtriva receive approval for European marketing. The European Commission is expected to give final approval late this year.

MILLENNIUM REDUCES QUARTERLY LOSS, BUT LOWERS OUTLOOK
Shares of MILLENNIUM PHARMACEUTICALS (MLNM, $12, down 12%) traded lower following release of the firm's 2Q financial results. While management trimmed the quarter's net operating loss, executives also lowered sales projections for Millennium's cardiovascular drug Integrilin. In addition, this year's sales projections for the firm's Velcade, a newly approved multiple myeloma drug, seemed overly conservative given the six-week sales data. While it is good to see Millennium reduce its losses, which has not occurred in many quarters, the lowered sales outlook dampened the enthusiasm for this company, which continues to project profitability by 2006.

For the second quarter, Millennium reported a pro forma net loss of $22 million, or 7 cents per share, on $120 million revenue. On a GAAP basis, the company lost $105 million, or 36 cents per share. The GAAP number includes a one-time $65 million restructuring charge and other write-downs associated with consolidation activities. Analysts expected Millennium to report a loss of 17 cents per share on $110 million revenue.

Millennium's oncology drug Velcade, which was approved in May, appears to have had a successful launch. Drug sales reached $8 million in six weeks. With such a fast start, one might project that drug sales could reach $40 million this year. However, management stated that 2003 Velcade sales are expected to near $25-30 million.

Millennium's cardiovascular drug Integrilin is also experiencing a soft market. Worldwide sales of Integrilin for the second quarter were $90 million, which brings Millennium $55 million in co-promotion revenue.

Millennium cut its full-year revenue target to a range of $410-420 million, which is $40-55 million less than originally projected. Given that Millennium did not get much of an upfront payment from its Velcade partnership, many analysts already were prepared for the company to not meet this year's revenue guidance. However, the revelation that Integrilin sales are weak is not going to get many investors excited about the potential of this cardiovascular drug. Millennium now expects to recognize co-promotion revenue for Integrilin in the range of $190-200 million this year, $20-25 million less than original guidance.

We recently stated that there did not appear to be many near-term incentives to propel Millennium's share price. Shares did not get much of a boost following the Velcade partnership, which left the earnings announcement as the next major event. Millennium management needs to show that they can continue to cut operating expenses as a means to move toward profitability. The next major milestones will come near year's end when the firm gives guidance (to further proceed or not) on Velcade's application in four oncology indications, some of which involve solid tumors. If Millennium can show that Velcade can be applied to other cancers, in addition to multiple myeloma, then the firm is poised to achieve its long-term goals.

European approval for Velcade is still moving forward and expected early next year. We have mentioned in the past the possibility of European approval this year, which would bring Millennium a significant milestone payment. However, the European Commission would have to work as fast as the US FDA on the Velcade drug application. We continue to favor the long-term aspects of an investment in Millennium. We do realize that the share price will be volatile, but the company has an approved anti-cancer drug, which also has shown encouraging results in the treatment of mantle cell lymphoma (a subset of non-Hodgkin's lymphoma). The share price did not greatly implode on the release of the lowered sales guidance, which signals that there are no longer a lot of investors waiting to unload shares. We expect the share price to trade in line with the rest of the sector until more favorable news is released.

MILLENNIUM PARTNERS VELCADE WITH ORTHO BIOTECH
MILLENNIUM PHARMACEUTICALS (MLNM) established an agreement with Ortho Biotech Products, a JOHNSON & JOHNSON (JNJ, $52, down 1%) company, to handle Velcade's overseas sales and co-develop the drug for additional cancer indications. Velcade is approved in the US to treat refractory patients with multiple myeloma.

Under the terms of the agreement, Millennium will retain all marketing rights in the US while Ortho will commercialize Velcade overseas. Millennium will receive royalties on overseas sales and will retain an option to co-promote Velcade in certain European countries at a future date.

Millennium will receive an upfront payment from Ortho Biotech of $15 million. In addition, Millennium may receive payments totaling $125 million for overseas regulatory approvals and sales for the multiple myeloma indication. Additionally, Millennium may receive payments of up to approximately $330 million for achieving overseas approval of Velcade in additional solid and/or hematological cancers, and up to $65 million upon achieving sales milestones outside of the US. The $330 million payment is partitioned for various cancer indications.

Millennium and Ortho Biotech will collaborate on the clinical development of Velcade in the United States, the European Union and Japan. The objective of this collaboration is to evaluate Velcade's capacity to treat multiple cancer types. Ortho will be responsible for 40% of the joint development costs through 2005 and for 45% of those costs thereafter. Total joint development costs, assuming success in multiple tumor types, may be up to $500 million based on existing development plans.

Investors were not too pleased with Millennium's Velcade partnership, as the stock sold-off on the news. Typically, marketing or development agreements between a large Drug firm and a Biotech company will include a payment that represents a premium to the going share price of the Biotech company -- for example, a Drug firm might like to grab a piece of a promising drug by paying a premium for 10% of a company's outstanding shares. With Millennium's deal, shares did not enter the transaction thereby giving investors little to get excited about. In addition, there were rumors that Millennium might be acquired, which led to an influx of short-term trading activity.

Ortho's upfront $15 million payment, which will be recognized over a few years, also disappointed investors, as it does little to boost 2003 revenue. One of Millennium's key multi-year R&D collaborations will end this year, which means that the firm will lose part of its revenue stream. At least Millennium has a good chance to receive a large portion of the $125 million milestone payment when Velcade receives European approval. Millennium filed its European marketing application in early February and approval is expected by early next year. If the European Commission works as fast as the US FDA, Velcade might receive approval this year, which would trigger the milestone payment and add to Millennium's 2003 revenue.

Millennium's deal is quite back-end loaded, but it's also a deal that favors the company over the long run. The firm has kept marketing rights in the US, which is the largest market, and Ortho will pick up nearly half of Velcade's R&D costs. With Velcade being evaluated in over three-dozen clinical trials, Millennium has incurred hefty R&D expenditures in the past. With Ortho's financial assistance, Millennium can begin to reduce its operating expenses, which have consistently increased each year.

Key for Millennium will be Velcade's approval for additional cancer indications. Since the drug offers a novel means to combat cancer cell growth, there is good potential for the drug to be used in combination with approved chemotherapeutics or anti-cancer biologics. The trouble with cancer cells is that they are generally defective in multiple genes, which implies that drug combinations, rather than a single agent, might be more effective in killing these cells. This is why Millennium is testing Velcade in combination with various chemotherapeutics against several cancer types. Velcade is not likely to be the "magic bullet" that thwarts all cancer growth, but it might increase the effectiveness of approved therapies.

3. THE BIO-TECHNICAL CORNER

We have remarked in recent weeks that Biotech stocks were losing their upward price momentum, and that investors should consider taking profits or hedging positions. Caution certainly has been warranted following the BTK's 58% gain between mid-March and early June. In addition, we have noticed a decline in the number of Biotech stocks hitting new 52-week highs and weakness among some of the technical indicators associated with the BTK's performance.

One question for investors to ponder is whether the BTK will establish a consolidation pattern between 420 and 470, or further weaken below 420 (the recent low). While we are hopeful that the BTK will be able to retain most of its gain, we also notice that the index is again dropping back to its 20- and 50-day moving averages (DMA). These moving averages generally serve as levels of technical support. In mid-June, the BTK briefly broke below its 20 DMA, but managed to spring higher. With the BTK already positioned near its short-term moving averages, we believe that general market weakness could easily drop the BTK back below the 50 DMA. Thus, we think that the 420 value, the previous low, holds greater significance as a technical support level.

As far as the upside potential is concerned, the BTK needs to close above the 500 mark to establish a new upward trend. The BTK made a recent attempt at the 490 value, but has since faded a bit lower. Such activity is representative of a double top pattern, which is indicative of investors taking profits into strength.



The chart presented above is courtesy of Stockcharts.com at http://stockscharts.com. The following definitions are also provided by Stockcharts: the CCI (Commodity Channel Index) is a momentum oscillator used to identify buy and sell signals, price reversals and trend strength; the MACD (Moving Average Convergence Divergence) is a comparison of moving averages, which are lagging indicators, to indicate trend; the RSI (Relative Strength Index) is a momentum indicator that compares the magnitude of gains against the magnitude of losses; the ADX (Average Directional Index) indicates the strength of an ongoing trend, and is derived from the forces of the positive directional indicator (+DI, green line) and the negative directional indicator (-DI, red line). In using the ADX indicator, technical analysts may derive buy and sell signals when the +DI line crosses above the -DI line (buy) or the -DI line crosses above the +DI line (sell).

4. PORTFOLIO TRACKER

THE BULL MARKET BIOTECH INVESTOR PORTFOLIO

The columns indicate the closing price of stocks on July 24th, the percent change over the past week (%Chg.) and the year-to-date percent change (%YTD). The table should be viewed with the courier font.

Security Symbol Close %Chg %YTD

Amgen AMGN 68 -3 41
Genentech DNA 78 1 136
Gilead Sciences GILD 66 1 94
Millennium Pharmaceuticals MLNM 12 -12 -14
Pfizer PFE 33 -1 6


Average Portfolio Return -1 44

The S&P 500 SPX 0 12
The Nasdaq Composite COMPQ 0 27
The Amex Biotech Index BTK 0 35
Biotech HOLDRS BBH 0 57



Good Biotech investing!



Robert Mendoza, Ph.D.
Editor
The Bull Market Biotech Investor
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Todd Shaver
Editor in Chief
The Bull Market Report
United States of America
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Disclaimer: Todd Shaver and other contributors to this newsletter may hold
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