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Jefferies 2010 Healthcare Conf


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Jefferies 2010 Healthcare Conf

  1. 1. Somaxon Pharmaceuticals, Inc. Jefferies Global Life Sciences Conference Nasdaq: SOMX June 10, 2010
  2. 2. Forward Looking Statements This presentation contains forward-looking statements about our business, including our commercialization timeline and plans, potential partnerships or other strategic collaborations, future financial results and events that have not yet occurred. Operating in the pharmaceutical industry inherently involves significant risks and uncertainties, including the risks outlined under “Risk Factors” and elsewhere in our Annual Report on Form 10-K and our other filings made with the SEC from time to time. Our actual results may differ materially from our expectations due to these risks and uncertainties, including our near-term dependence on the success of our lead product candidate, Silenor®, and factors relating to ability to raise sufficient capital, ability to attract a strategic partner, competition, intellectual property protection, industry environment, and other matters. Somaxon undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. 7
  3. 3. Somaxon Business Strategy Develop and Commercialize Highly Differentiated Products – Target late-stage or currently marketed assets – Address unmet medical need and patient dissatisfaction – Maximize value of Silenor Deploy a U.S. Commercial Organization – Focus on the CNS therapeutic area – Cover high-prescribing physicians with a targeted sales force – Create efficiencies through strategic outsourcing Establish Commercial Collaborations – Effectively leverage partner resources – Reach broader prescriber universe – Consider licensing, co-promotion or M&A to accelerate growth 8
  4. 4. Highlights FDA approved Silenor for the treatment of insomnia characterized by sleep maintenance difficulty, March 17, 2010 Raised $53MM in secondary offering in March 2010 U.S. commercial collaboration discussions ongoing Somaxon’s commercial build-out underway Silenor launch in 2H 2010 Pursuing ex-U.S. Silenor licensing partner(s) 9
  5. 5. Silenor for Insomnia Near-term Opportunity – Target launch 2H 2010 – Favorable market dynamics commercial upside – Launch Ready campaign – Product profile supports potential for meaningful share of the market Silenor – A Highly Differentiated Product for Insomnia – Differentiated Mechanism of Action • H1 affinity vs. GABA or melatonin – Strong Clinical Efficacy Profile • Primary efficacy endpoint achieved statistical significance in all four Phase 3 studies • Sleep maintenance ≥ 7 hours – Favorable Safety and Tolerability Profile • Not scheduled • Adverse events comparable to placebo • No GABA-ergic related side effects 10
  6. 6. A Restless Market
  7. 7. Large and Accessible Market Over 67 million TRx’s and > $2 billion in sales in the U.S. 2009 U.S Market remains under-diagnosed and under-treated – 70 million estimated to suffer from insomnia – 14 million (20%) are currently on Rx treatment – 56 million utilize OTC/not on Rx treatment Concentrated market: ~44,000 doctors write half the TRx’s – 30% of highest prescribing doctors are specialists • Top decile prescribers average >1000 Rx’s /year Opportunity to accelerate prescription growth with the introduction of a novel and differentiated product – 70% of patients would ask for Silenor on the next doctor visit – 12% of patients stated they would make a special visit to ask for Silenor Sources: IMS Health data, Roth et al, 1999, Somaxon Market Research_2008 (Insomnia Treatment: The Consumer Perspective N=1,764) 12
  8. 8. Sleep Maintenance is Primary Issue Sleep Problem in Past Month At Least a Few Nights/Week Rarely, Never, Any Sleep Problem 26% Don’t know Difficulty Falling Asleep 65% 29% Early Morning Awakenings 42% Frequent Nocturnal 35% Awakenings 49% Woke Unrefreshed National Sleep Foundation. Summary of findings: 2008 Sleep in America poll. n = 1760 respondents 13
  9. 9. Insomnia Market Current options force patients and physicians to compromise – GABA-ergic drugs provide varying degrees of efficacy but involve compromise on tolerability and risk of addiction – OTCs address addiction concerns but involve compromise on efficacy and tolerability – Melatonin-receptor agonists address addiction and tolerability concerns but involve compromise on efficacy Only 25% of patients “Very Satisfied” with current insomnia prescription and 40% claim they switched medications in the last year. Source: Somaxon Market Research_2008 (Insomnia Treatment: The Consumer Perspective N=1,764) 14
  10. 10. A Novel Treatment for Insomnia Silenor
  11. 11. Starting With a Differentiated Mechanism of Action Histamine (H1) is one of several waking neuro-transmitters important in the arousal system Silenor has high affinity for H1 receptors – Twenty-fold more potent than diphenhydramine, and significantly more selective Silenor has significant effects at night through the blockade of H1, which promotes and maintains sleep Specific H1 blockade does not prevent or diminish arousal due to other neurotransmitters in the arousal system Sources: Mansbach, ECMP 2008 Poster Presentation 16
  12. 12. Sleep Efficiency Throughout the Night 95% 90% 85% 80% PBO Sleep Efficiency 75% DXP 3 mg 70% DXP 6 mg 65% 60% 55% Hour of the Night 50% 1 2 3 4 5 6 7 8 3 mg 0.0671 0.0014 0.0002 0.0650 0.0693 0.0063 0.3916 <0.0001 6 mg 0.1040 0.0001 0.0006 0.0020 0.0282 <0.0001 0.0492 <0.0001 Source: Somaxon Phase 3 Clinical Study Results (Study SP-0501 Adult Chronic 35 day) 17
  13. 13. Incidence (%) of Treatment-Emergent Adverse Reactions in Long-term Placebo-Controlled Clinical Trials Silenor Silenor System Organ Class Placebo 3 mg 6 mg Preferred Term* (N=278) (N=157) (N=203) Nervous System Disorders Somnolence/Sedation 4 6 9 Infections and Infestations Upper Respiratory Tract 2 4 2 Infection/Nasopharyngitis Gastroenteritis 0 2 0 Gastrointestinal Disorders Nausea 1 2 2 Vascular Disorders Hypertension 0 3 <1 * Includes reactions that occurred at a rate of ≥ 2% in any Silenor-treated group and at a higher rate than placebo. 18 Source: Silenor® Package Insert_March 2010
  14. 14. Silenor: Just What the Patient Ordered Treat sleep maintenance insomnia – The most significant insomnia complaint – 7-8 hours of sleep with Silenor Prevention of early morning awakenings – a full night’s sleep – Unique potential positioning for Silenor Attractive safety profile – NO clinically meaningful evidence of next-day residual effects – NOT DEA scheduled – NO abuse potential – NO risk of dependency – NO withdrawal symptoms – NO tolerance with long term use – NO complex sleep behaviors observed – NO amnesia, hallucinations or other GABA-related side effects – NO disruption of sleep stages 19
  15. 15. Silenor Commercialization Silenor
  16. 16. Changing Market Dynamics Create Opportunities Solid “window of opportunity” for new treatments – A void of new and differentiated insomnia treatments since 2006 – No “novel” compounds expected to launch in near term • Clinical and regulatory setbacks for several drugs in development • Somaxon estimates several years before new competition comes to market Number of primary details is decreasing – Recent sales force reductions – Competitive brands lack differentiated message Competitive promotional spending is decreasing – DTC spending down dramatically year-over-year – Consistent trend across brands 21
  17. 17. “Plan to Win” Capitalize on the Changing Market Dynamics – Competitor “turbulence” – Lack of differentiated insomnia treatments – Shift from expensive DTC strategy Pre-launch - Raise Awareness – Web based initiatives – Publications – Professional meetings (e.g. APSS) Launch with a Competitive Sales Force – Target high value physicians – Utilize non-personal promotional efforts to leverage into lower deciles – Exploit Silenor sampling advantage Integrated Professional Campaign Developed – Strong branding elements – Patient Education Programs – Technology driven physician education Targeted Consumer Campaign Developed – “Direct to Insomniac” communication via Web – Point of Care Programs/Public Relations 22
  18. 18. Silenor Branding Brand Identity – Refreshingly Different Positioning -Silenor is first-line therapy for sleep maintenance insomnia Key Messages – A full 7-8 hours of sleep Broad clinical profile – Safe for chronic use Safety – Non-addicting, no abuse potential Tolerability – Placebo-like side effect profile Patient benefits – No meaningful hangover effect – Unique MOA 23
  19. 19. Professional Campaign Integrated marketing campaign to reach High Value Physicians (HVP) with both personal and non-personal promotional efforts – Messaging Finalized • Supportive sales aids and branded marketing materials – Brand Awareness programs – Leverage on-line/media Packaging designed to reinforce Brand imagery and product features – Reliance on dose pack but bottles available – Sample and trade packaging identical and distinctive Samples – a competitive advantage – Drives physician access – 4 count sample packs for sales rep delivery and direct distribution 24
  20. 20. Silenor Branding 25
  21. 21. Patient Starter Kit 26
  22. 22. Patient Brochure / Co-Pay Card 27
  23. 23. Silenor Dose Pack 28
  24. 24. Direct to Consumer Campaign Web and Point of Care outreach “Direct to Insomniac” Web property deployment – – Search engine optimization – User database Outreach through Web MD – Directed approach – Most trusted and searched website for medical inquiries Public Relations – Media outreach at launch Point of Care – Pharmacy – Direct product messaging to OTC sleep aid and anti-depressant users Point of Care – MD Office – In-office video and print materials • Rep and direct distributed 29
  25. 25. 30
  26. 26. Somaxon Pharmaceuticals, Inc. Corporate Summary
  27. 27. Commercial Collaboration for Silenor Traditional M&A to Co-promotion licensing gain access to with shared with sales revenues and co-promotion infrastructure/ costs rights products GOALS Successful Silenor launch in 2H 2010 Build a focused Somaxon commercial organization Maximize shareholder value 32
  28. 28. Financials Cash, cash equivalents $58.5 MM & marketable securities (3/31/10) Shares outstanding 34.3 MM Fully diluted shares 42.7 MM 33
  29. 29. Somaxon Value Proposition Silenor – Highly differentiated insomnia treatment – Favorable market dynamics – “Launch ready” campaign – Attractive market potential Experienced management team – Significant commercial transaction and product launch experience 2010 milestones – Potential Silenor commercial collaboration(s) – Deploying a specialty commercial operation – 2H 2010 Silenor launch in US 34
  30. 30. Somaxon Pharmaceuticals, Inc.