10-12-07 lehman, j.birchenough, et alia
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We recently assumed coverage of small-cap biotech, where we advise stock selectivity for a high-beta group that trades primarily on product news flow. ! Overall, 2007 has been a difficult year for the small-cap biotech group, with challenging capital market conditions and a risk-averse FDA causing investors to steer away from development-stage companies and into mid- and large-cap biotech companies with strong earnings growth stories and stable cash flows. ! While we do not foresee a sustained recovery in the near term for the small-cap biotech group in the absence of improved capital markets, a consistently friendlier FDA, or pickup in M&A, we do expect higher-quality names to ultimately lead the way out of the current downturn. ! We favor companies with strong drug discovery platforms and deep product pipelines that diversify risk and fund product development (e.g., ISIS), along with companies that are expected to generate proof-of-concept data that could provide significant value inflection with limited binary downside risk (e.g., ARRY). ! We also like companies that have drugs with demonstrated significant proof-ofconcept data in Phase II but that, in our view, remain underappreciated by investors going into Phase III (e.g., ACAD and SNTA). ! We recently assumed coverage of 16 companies with 10 price target changes and initiated coverage of two companies. Our favorite names going into 2008 include ACAD, ARRY, NBIX, and SNTA. Key upcoming events include an FDA panel meeting for CRME on December 11–12, a PDUFA date for NBIX on December 12, Phase II data for RIGL in rheumatoid arthritis in December, a PDUFA date for ADLR on February 10, and a Phase III interim safety assessment for ARNA in 1Q08.
Table of Contents Introduction....................................................................................................... 3 Lehman Brothers U.S. Small-Cap Biotech: Valuation Comparison ................................ 5 Highlighted Key Near-Term Events ........................................................................ 6 Company Snapshots and Outlooks: 1-Overweights .................................................. 7 Company Snapshots and Outlooks: 1-Overweights (cont’d) ....................................... 8 Company Snapshots and Outlooks: 2-Equal weights ................................................ 9 Company Snapshots and Outlooks: 2-Equal weights (cont’d).................................... 10 Company Snapshots and Outlooks: 3-Underweights............................................... 11 Lehman Brothers U.S. Small-Cap Biotech: Valuation Methodologies........................... 12 Sector Overview.............................................................................................. 13 Company Updates........................................................................................... 17 Acadia Pharmaceuticals (ACAD, 1-Overweight)................................................. 18 Adolor (ADLR, 3-Underweight) ........................................................................ 22 Atherogenics (AGIX, 3-Underweight) ................................................................ 24 Ariad Pharmaceuticals (ARIA, 1-Overweight) ..................................................... 26 Arena Pharmaceuticals (ARNA, 2-Equal weight) ................................................. 29 Array Biopharma (ARRY, 1-Overweight)............................................................ 33 Cardiome Pharma (CRME, 2-Equal weight) ....................................................... 35 Cell Genesys (CEGE, 2-Equal weight).............................................................. 37 Genomic Health (GHDX, 2-Equal weight) ......................................................... 39 ISIS Pharmaceuticals (ISIS, 1-Overweight) ......................................................... 42 Neurocrine Biosciences (NBIX, 1-Overweight) ................................................... 45 NPS Pharmaceuticals (NPSP, 2-Equal weight) .................................................... 50 Nuvelo (NUVO, 2-Equal weight)..................................................................... 53 Rigel Pharmaceuticals (RIGL, 1-Overweight)....................................................... 56 Sunesis (SNSS, 1-Overweight) ........................................................................ 59 Synta Pharmaceuticals (SNTA, 1-Overweight) .................................................... 62 Telik (TELK, 3-Underweight) ............................................................................ 66 Tercica (TRCA, 1-Overweight) ........................................................................ 75 Appendix: Lehman Brothers Biotech Index............................................................. 78
NORTH AMERICA ARRY: We recently initiated coverage of ARRY with a 1-Overweight rating and $16 price target. The basis of our rating is what we believe is an undervalued best-in-class drug discovery platform and deep pipeline, with 10 proprietary small-molecule compounds that will be in the clinic by year-end 2008, eight of which are wholly owned by ARRY. We see three candidates in Phase II by year-end 2007 that will generate proof-of-concept data over the coming year. The best comp we can think of is Exelixis, with a market cap of $1.05 billion, more than double that of ARRY. ACAD: We recently raised our price target for ACAD (1-Overweight) to $28 from $18, supported by our product NPV analysis. Positive Phase II results for pimavanserin in schizophrenia have defined a new treatment paradigm as add-on therapy for antipsychotics, following which we expect a partnership in the near term in a $15 billionplus market where extending the life of existing franchises is critical for major pharma. We expect NBIX (1-Overweight) to receive indiplon capsule approval on December 12 and believe that the company will partner the drug prior to an early 2008 launch, with upside to our $18 price target following both events. Following the recent announcement on October 10th of SNTA’s (1-Overweight) recent partnership with GSK for STA-4783, we believe that positive Phase III data by year-end 2008 is realistic. We maintain our 1- Overweight ratings on ARIA, ISIS, SNSS, and TRCA, for which we continue to expect long term-upside on anticipated positive product news flow and partnering activity. CRME: We recently initiated coverage of CRME with a 2-Equal weight rating and $10 price target. Lead product vernakalant for atrial fibrillation (abnormal heart rhythm) is under review by the FDA for an IV formulation, and an oral formulation is in Phase IIb development. We believe that success with the IV at an FDA panel review meeting in December is more than fully valued in the stock. We anticipate subsequent risk and extended timelines for oral vernakalant, with significant additional long-term data on safety and efficacy that will need to be amassed. ARNA: We recently lowered our price target for ARNA (2-Equal weight) to $10 from $14 and expect the stock to continue to come under pressure heading into an interim 12-month safety assessment for obesity drug lorcaserin in 1Q08, where we expect no upside and see significant downside risk. We remain cautious with 2-Equal weight ratings ahead of potentially binary data points for CEGE, GHDX, NPSP, NUVO, and RIGL, where outcomes are difficult to assess at this time. We highlight that for RIGL we foresee significant upside potential, albeit with a low probability of success, and limited downside at current levels on positive data for lead drug R788 in rheumatoid arthritis (RA) in December.
We maintain 3-Underweight ratings on ADLR, AGIX, and TELK following failures in Phase III trials over the last year, where success continues to rely on single lead product opportunities that we believe cannot be salvaged. Our favorite names going into 2008 include Acadia Pharmaceuticals, Array Biopharma, Neurocrine Biosciences, and Synta Pharmaceuticals. We also maintain 1-Overweight ratings on Ariad Pharmaceuticals, ISIS Pharmaceuticals, Sunesis, and Tercica, where we continue to expect long-term upside on anticipated positive product news flow and partnering activity. We remain cautious with 2-Equal weight ratings ahead of binary data points for Arena Pharmaceuticals, Cell Genesys, Genomic Health, NPS Pharma, Nuvelo, and Rigel, where outcomes are difficult to assess at this time. We are cautiously optimistic on prospects for NPSP, NUVO and RIGL and less so for ARNA, CEGE and GHDX based on our perception of risk/reward at these levels. Lastly, we are maintaining Underweight ratings on Adolor, AtheroGenics, and Telik following failures in Phase III trials over the last year, where success continues to rely on single lead product opportunities that we believe cannot be salvaged. |