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Agouron Pharmaceuticals Inc. - 18 May 1998
Price: $34 3/8 Estimates (Jun) 1997A 1998E 1999E EPS: d$1.60 $1.00 $1.05 P/E: NM 34.4 32.8 EPS Change (YoY): NM NM Cash Flow/Share: d$1.44 $1.22 $1.29 Price/Cash Flow: NM 28.2 26.7 Dividend Rate: Nil Nil Nil Dividend Yield: Nil Nil Nil Opinion & Financial Data Investment Opinion: D-2-2-9 Mkt. Value / Shares Outstanding (mn): $1,134.4 / 33 Book Value/Share (Mar-98): $7.18 Price/Book Ratio: 4.8x ROE 1998E Average: 15.0% LT Liability % of Capital: 2.3% Est. 5 Year EPS Growth: NM Stock Data 52-Week Range: $56 « - $26 _ Symbol / Exchange: AGPH / OTC Options: AMEX Institutional Ownership-Spectrum: 52.8% ML Industry Weightings & Ratings** Strategy; Weighting Rel. to Mkt.: Income: Underweight (07-Mar-95) Growth: Overweight (07-Mar-95) Income & Growth: Overweight (07-Mar-95) Capital Appreciation: Overweight (31-Aug-94) Market Analysis; Technical Rating: Above Average (24-Feb-98) **The views expressed are those of the macro department and do not necessarily coincide with those of the Fundamental analyst. For full investment opinion definitions, see footnotes.
Investment Highlights: ú Initiating coverage of Agouron with a rating of Intermediate and Long Term Accumulate. ú It's lead drug Viracept, for the treatment of AIDS, has gathered significant market share and is expected to generate $400 of sales in the US this year. ú Our C1998-2000 EPS estimates are $0.90, $1.26, and $1.63 (excluding one-time items). Our 12-18 month price objective is $40 per share, based upon a 25 multiple applied to our C2000 EPS estimate.
Fundamental Highlights: ú Viracept, the company's lead product for AIDS, is likely to achieve worldwide revenues of $950 million by 2001. ú Viracept does not seem to be threatened for the next three years, and the company is working on follow-on AIDS drug candidates. ú Other product candidates are in early clinical testing with no proof of efficacy. ú At the end of F3Q98, the company had $117 million in cash, and little debt. Positive cash flow is projected through 2002.
Overview Agouron's sole marketed product is Viracept, an HIV protease inhibitor, that was approved by the FDA in March 1997 for the treatment of AIDS. In the first three quarters of fiscal 1998, Viracept US sales totaled $283 million. Viracept is marketed by Agouron in the US and by Roche in Europe. Japan Tobacco collaborated on the development of the drug and receives a 50% split of the profits from the US, and has retained marketing rights in Japan. We expect worldwide Viracept sales to achieve $465 million in the 1998 calendar year, $675 million in 1999, $850 million in 2000, and more than $950 million in 2001. At peak, we believe more than 150,000 patients worldwide will be on Viracept therapy.
Viracept Viracept is an oral protease inhibitor (PI) designed for the treatment of AIDS. The drug demonstrates an ability to decrease the HIV viral load and increase CD4+ cell count. These positive effects are most evident when Viracept is given in combination with reverse transcriptase inhibitors. The drug is well tolerated. Viracept has to be taken three times per day, but not at strict eight hour intervals like its main competitor, Crixivan. In addition, patients can take Viracept with food. Agouron is currently testing whether Viracept can be given twice daily and still retain efficacy, and whether it will be effective as a member of a dual PI regimen. Agouron has positioned Viracept as the protease inhibitor of choice, because if patients become resistant, they can switch to a regimen containing a different PI and get a second chance. This idea is controversial, but does have some support in the research and clinical community. For this to be true, the change in drug regimen has to be done rapidly to insure that mutant strains do not have time to emerge. Thus, careful and frequent monitoring of patients is essential.
Competition for Viracept The major risk for both the stock and the company stems from competition in the AIDS arena, including Merck's Crixivan, dual PI therapy with Norvir/ Fortovase and the perceived threat of other protease inhibitors in development, including Vertex/Glaxo's Amprenavir and Abbott's ABT-378. Data has been presented that indicates that Amprenavir, like Viracept, has less resistance overlap to Crixivan, Norvir, and Invirase/ Fortovase. In the longer-term, we estimate that there are at least four other protease inhibitors in clinical testing and many more in the research stage.
Other Products Agouron has two anti-cancer compounds in clinical development, AG3340 and AG2034. AG3340, is an orally-administered, matrix metalloprotease (MMP) inhibitor that blocks angiogenesis. Agouron has just announced the initiation of two Phase II/III clinical trials of AG3340 in patients with advanced lung or prostate cancer. AG3340 in combination with Taxol and Paraplatin will be administered to patients with advanced non-small cell lung cancer. The primary endpoint of this trial is time to progression. In the second trial, patients with advanced prostate cancer will receive AG3340 in combination with Novantrone and prednisone. The primary endpoint in this trial is time-to-symptomatic progression of disease. Results from these trials are expected in 2000. AG2034 is an inhibitor of glycinamide ribonucleotide formyl transferase (GART), an enzyme necessary for cellular proliferation. A Phase I study has just been completed and results are expected this month.
Financials and Valuation We expect Agouron's F1998 $400 million estimated US sales to grow only modestly to about $500 million in 2001. Outside the US, sales should continue to grow well from $54 million in 1998 to $470 million in 2001. Worldwide sales should increase from $460 million in 1998 to $950 million in 2001, for an annual sales growth rate of 25% over this period. This anticipated sales growth will not be clearly reflected in comparable EPS growth for Agouron because of marketing agreements with Japan Tobacco and Roche. On US Viracept sales, AGPH and JT equally split the profits, which we have modeled as an effective sales royalty of 17% to JT. As for European sales, Agouron receives an up front payment for delivery of bulk product to Roche and royalty based on sales. We estimate that this marketing arrangement results in royalties to Agouron amounting to about 10% of total Viracept sales in Europe. We have modeled R&D expenditures of $121 million and $127 million in F1998 and F1999 respectively, as the company pushes forward with clinical development of AG3340. Likewise, SG&A is expected to grow from $58 million to $65 million over the next year to accommodate increased Viracept marketing efforts, and then stabilize over the next 3 years. The operating structure should allow operating margins to be 14-15% through 2002. Our EPS estimates for F1998 to F2002 are $1.00, $1.05, $1.46, $1.80 and $1.83, with a 3 year compounded annual growth rate of 20%. The bulk of the EPS growth would occur in F2000 and F2001 during the rapid growth of international sales of Viracept. Agouron should end F1998 with $120 million in cash and almost no debt.
Valuation Assuming Agouron can achieve our earnings targets, what is the appropriate multiple to pay for a company with one significant product and nothing else significant in late stage development? Based on recent analyses, we believe a reasonable trading range for a mature, single-product company is 20-25 times mature earnings. Currently the stock trades at about 28 times our calendar 1999 estimate of $1.26, versus 29 times for the drug group and 25 times for the Big 6 Biotechs. We believe the growth of earnings will be mostly driven by royalties from international sales. By year end 1999 we expect the stock to trade at 25 times our C2000 estimate of $1.63 or $40 per share in the next 12-18 months. Over the long term, the company needs to undertake strategic initiatives to become a multi-product company with long tailed earnings growth. Opinion Key [X-a-b-c]: Investment Risk Rating(X): A - Low, B - Average, C - Above Average, D - High. Appreciation Potential Rating (a: Int. Term - 0-12 mo.; b: Long Term - >1 yr.): 1 - Buy, 2 - Accumulate, 3 - Neutral, 4 -Reduce, 5 - Sell, 6 - No Rating. Income Rating(c): 7 - Same/Higher, 8 - Same/Lower, 9 - No Cash Dividend. |