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**** Hambrecht & Quist **** Hambrecht & Quist **** Hambrecht & Quist **** Company: BiogenPrice: 66.88Recommendation: Market PerformNotes: a,e,f Date: 7/9/99 1 of 2 Biogen Reports Solid Q2 Results; Reiterating Market Perform Rating Biogen reported Q2 EPS of $0.34 (less the one-time charge) on total revenues of $188.9 million, both of which were better than our EPS estimate of $0.31 on revenue estimate of $184.5 million. A combination of strong Avonex sales and lower R&D expenses contributed to the improved bottom line results. With its current $66 stock price reflectig a 10X multiple of 2000 revenues, this valuation discounts a most optimistic view of the future. We maintain our Market Perform Rating. 1998 A Previous Est 1999 E Previous Est Q1 EPS $0.18 $0.18 $0.29A $0.29 Q2 EPS $0.21 $0.21 $0.34A 0.31 Q3 EPS $0.25 $0.25 $0.36 0.33 Q4 EPS $0.27 $0.27 $0.36 0.34 FY EPS $0.91 $0.91 $1.35 $1.27 FY REVS (M) $557.6 $557.6 $778.0 752.7 CY EPS $0.91 $0.91 $1.35 $1.27 CY P/E 74.1 74.1 49.4 52.5 FY Ends Dec Current Price $66.69 52-Week Range $20.9-67.5 Market Cap(M) $10510.3 Shares Out(M) 157.6 Book Value $5.50 Net Cash/Share $3.87 3-Year EPS Gth 37.3% CY99 P/E-to-Gth 132%Summary Biogen reported solid Q2 results after the market close yesterday. The company posted EPS of $0.28, which included a one-time charge of $15.3 million ($0.06 per share) for writing-down several marketable securities to current market value. Less the one-time charge, Biogen reported EPS of $0.34 on total revenues of $188.9 million, both of which were better than our EPS estimate of $0.31 on revenue estimate of $184.5 million. A combination of strong Avonex sales and lower R&D expenses contributed to the improved bottom line results. We are adjusting our year-end revenue and EPS estimates to $778.0 million and $1.29 ($1.35 net of one-time charge) from $752.7 million and $1.27, respectively. The stock is now trading at 45X our 2000 EPS estimate of $1.50, which we believe fully discounts our growth expectations for both Avonex sales and earnings. On the conference call last night, the management noted that Avonex sales growth may slow in Q3 based on seasonality and also anticipates significantly higher R&D expenses in 2000. Avonex Sales Continue To Tread Higher, But Management Cites Seasonality for Next Quarter Biogen's product Avonex remains the key component of revenues and earnings. Avonex sales for the quarter were particularly strong, coming in at $145.9 million, up 11% from Q1 and 67.5% from Q2 last year. This was above our $142.5 million estimate. The company reported $104 million in sales in the U.S. region and $41 million in Europe. During the quarter, Biogen added 5,000 new patients in the US, and about 2,000 patients in Europe, bringing the total number of patients on Avonex therapy at the end of Q2 to over 51,000 and 18,000 respectively, in those regions. Avonex remains to be the market leader in the U.S., maintaining a healthy 60% market share in U.S. over its competition including Betaseron and Copaxone. In addition, Avonex holds 40% of the European market, tied roughly with Betaferon while Rebif's market share holds in the mid-teens. This continued growth in Avonex has been largely due to adoption of the 'treat early' mantra among physicians as clinical data show that the early use of beta interferon slows brain atrophy and disease progression. However, the management noted that Q2 has been generally the strongest quarter for Avonex, and anticipates seasonal slowdown in Avonex sales growth for Q3. Total Expenses In Check, But Anticipated to Increase Dramatically Next Year Biogen posted total expenses of $114.9 million, lower than our estimates of $118.1 million. All three line items - COGS, R&D, and SG&A -were all belwo what we had anticipated. Although Biogen's expense growth has historically kept in line with revenue growth, the management on the conference call last night announced that it intends to aggressively invest in its product pipeline. Both Amevive and Antova are expected to begin large multi-center trials early next year. Consequently, R&D expenses are expected to accelerate next year to about $300 million, up about 37% from this year-end's estimated total expenses of $223.1 million. Finally, Biogen reported $21.3 million in taxes for Q2, reflecting a 33% tax rate that is expected to carry out for the remainder of the year. Biogen's Product Portfolio RoundupAmevive (LFA3-TIP) In early June, Biogen announced the preliminary phase IIb trial data of Amevive in treating patients with moderate-to-severe psoriasis. Although not much detail was disclosed regarding these data, from the data points provided it appears that the produced showed promising efficacy in these patients. Amevive is a recombinant fusion protein made up of two parts: (1) the Fc portion (also called the constant region) of a human IgG1 antibody linked to (2) a human LFA-3 domain that binds to the CD2 receptor on T cells. Amevive is designed to block the LFA-3/CD2 signaling pathway, which is believed to be an integral part of T-cell activation. Ideally, Amevive would function as a more specific immunosuppressant in treating diseases with an autoimmune component, inactivating disease-causing T cells while leaving the rest of the immune system unaffected. On the conference call, management confirmed its intent to initiate late-stage clinical trials for Amevive later this year. It appears that Biogen has several issues that it must resolve with the FDA prior to launching these trials, which include 1) identifying the optimal dose and schedule 2) deciding among different administration routes (intramuscular, intravenous, or subcutaneous) 3) improving the manufacturing process. Antova (Anti-CD40L Antibody) Our favorite product in Biogen's pipeline is Antova, a humanized monoclonal antibody with potential activity in various autoimmune diseases and transplant rejection. This antibody targets the CD40 ligand (also called gp39 or CD154) expressed on activated T cells. The CD40L binds another cell surface receptor called CD40 on B cells and other white blood cells, initiating a cell-mediated immune response and subsequent inflammatory response. By blocking this critical T cell-B cell communication, the anti-CD40L antibody may potentially serve as a powerful and safe immunosuppresive drug. Biogen currently has two open-label Phase II studies, one for renal transplant patients and the other for patients with a rare platelet disorder called idiopathic thrombocytopenic purpura (ITP). The first tranche of patients for both indications have been fully enrolled and have begun dosing. The company plans to begin the second stage of the Phase II studies later this year after evaluation of the first group. The company has also initiated a clinical study for factor VIII hemophilia, and is planning to begin Antova clinical trials for lupus, islet cell transplantation, and multiple sclerosis. In total, Biogen will be evaluating Antova in six different indications by year- end. The company is expecting to present clinical data Amevive for ITP at the upcoming American Society of Hematology (ASH) meeting in December. In mid-June, Biogen and related parties published promising data on Antova for renal allotransplantation in primate models (Nature Medicine, Vol.5, No.6, June 1999, p.686-693). These results suggest the following several key points, which bode well for the future prospects of the drug: |