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Trius sept12confpresentation

  1. The Future of Anti-Infectives Baird Healthcare Conference September 5, 2012 1
  2. Forward looking statements Statements made in this presentation regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trius’ ability to successfully complete its ongoing clinical trials and development programs, the expected timing for reporting of top-line data for the TR701-113 study, Trius’ ability to obtain regulatory approval for tedizolid, market penetration and acceptance of tedizolid and the initiation of clinical studies for Trius’ Gyrase B program. Risks that contribute to the uncertain nature of the forward-looking statements include: Trius’ future preclinical studies and clinical trials may not be successful; changes in regulatory requirements in the United States and foreign countries may prevent or significantly delay regulatory approval of Trius’ products; Trius may change its plans to develop and commercialize its product candidates; the FDA may not agree with Trius’ interpretation of the data from recently-completed clinical trials of tedizolid; Trius may decide, or the FDA may require Trius, to conduct additional clinical trials or to modify Trius’ ongoing clinical trials; Trius may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Trius’ ability to obtain regulatory approval; the third parties with whom Trius has partnered with for the development of tedizolid and upon whom Trius relies to conduct its clinical trials and manufacture its product candidates may not perform as expected; tedizolid may not receive regulatory approval or be successfully commercialized; unexpected adverse side effects or inadequate therapeutic efficacy of tedizolid could delay or prevent regulatory approval or commercialization; Trius’ may be unable to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; Trius’ ability to obtain additional financing; and the accuracy of Trius’ estimates regarding expenses, future revenues and capital requirements. These and other risks and uncertainties are described more fully in Trius’ most recent Form 10-K, Forms 10-Q and other documents filed with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in such filings. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trius undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. 2
  3. Investment highlights • Focus on novel antibacterial compounds for serious infections • Tedizolid completing confirmatory ESTABLISH-2 Phase 3 trial – ESTABLISH-1 trial met all primary and secondary endpoints – NDA filing for acute bacterial skin and skin structure infections (ABSSSI) expected 2H 2013 – De-risked asset with high efficacy, strong safety, and convenience – Additional opportunities in lung and blood stream infections • Broad spectrum gyrase program entering clinic in 2013 • Significant potential near-term catalysts • Strong balance sheet 3
  4. Trius pipeline Pre-clinical Phase 1 Phase 2 Phase 3 Tedizolid Phosphate Oral ABSSSI IV/Oral HAP/VAP IV Bacteremia IV/Oral GyrB/ParE Gram- Infections IV 4
  5. Strong growth in MRSA* treatment days Total hospital treatment days in US (Vancomycin, Linezolid and Daptomycin) 25.8M 24.0M 22.2M 21.1M 21.0M 16.7M 2005 2006 2007 2008 2009 2010 Source: AMR (United States market) *methicillin-resistant Staphylococcus aureus 5
  6. Increasing resistance to vancomycin Resistance of MRSA against Vancomycin 11.1% 9.2% 3.8% 3.3% 2.8% 2005 2006 2007 2008 2009 Source: Theravance Company Report, April 2010 & AMR (United States market). AMR - Hospital Insight Series, US Data, August 2011 6
  7. Physician attitude on vancomycin is changing Percent of physicians reporting decreased or increased perscriptions 51% 39% More 9% 8% 6% Less 48% Vancomycin Zyvox Cubicin Source: AMR - Hospital Insight Series, US Data, August 2011 7
  8. Tedizolid: highly differentiated oxazolidinone Tedizolid Linezolid (Zyvox) Week 1 Week 2 Week 1 Week 2 8
  9. Strong product profile Generic Attribute Linezolid Vancomycin Daptomycin Tedizolid IV/Oral  X X  In-Vivo Bactericidal X    Active in Lung Infections   X  Once Daily Treatment X X    Short Course of Therapy X X X 9
  10. Phase 3 trial design: ESTABLISH-1 (oral), ESTABLISH-2 (IV/PO) Safety Analysis Tedizolid 1x 200mg Placebo n=667 Post-Treatment Evaluations Linezolid 2x 600mg 1o 2o 1o 2o FDA FDA EMA EMA END-POINTS FOR GLOBAL REGISTRATION 10
  11. 1o endpoint achieved: current & expected guidance 79.5% 79.4% 78.0% Tedizolid 76.1% Linezolid Current Guidelines* Expected Guidelines** Lesion Criteria (Area) Lesion Criteria (Area) No increase from baseline ≥20% reduction from baseline Fever Criteria (Temperature) Fever Criteria (Temperature) Measurements required Excluded* * Primary endpoint as agreed to under Study 112 and 113 SPA ** FNIH recommendations to FDA: ABSSSI Docket ID: FDA-2010-D-0433 11
  12. Significantly lower impact on platelets 75% - 100% LLN (112-150K/μL) <75% LLN (<112K/μL) 14.9%* 9.2%* 4.9% 2.3% Linezolid Tedizolid * Statistically significant difference 12
  13. Phase 3: lower rates of adverse events Linezolid Tedizolid 43.3% 40.8% 31.0% 24.2% 25.4% 16.3%* Any TEAE Drug-Related TEAE GI Disorder TEAE = Treatment Emergent Adverse Event Gastrointestinal AEs incl. diarrhea, nausea, vomiting & dyspepsia * Statistically significant difference: p = 0.004 13
  14. Tedizolid on track toward market • Enrollment of ESTABLISH-2 trial (IV > PO) on track • Expected top line data H1 2013 • Expected NDA filing H2 2013 • Potential NDA approval mid 2014* * With Priority Review afforded by the GAIN Act 14
  15. Upcoming catalysts and milestones ogramEvent Timing Present Abstracts at ICAAC Sep 2012 Top-line Data - 2nd Phase 3 in ABSSSI H1 2013 Tedizolid File NDA H2 2013 Potential European Partnership 2012/13 Potential U.S. Launch 2014 Gyrase Present Abstracts at ICAAC Sep 2012 File IND/Initiate Phase 1 2013 15
  16. Capitalization Cash and Marketable Securities (6/30/12) $84M Long-term Debt (6/30/12) $0M Shares Outstanding (8/1/12) 38.8M 16
  17. Investment highlights • Focus on novel antibacterial compounds for serious infections • Tedizolid completing confirmatory ESTABLISH-2 Phase 3 trial – ESTABLISH-1 trial met all primary and secondary endpoints – NDA filing for acute bacterial skin and skin structure infections (ABSSSI) expected 2H 2013 – De-risked asset with high efficacy, strong safety, and convenience – Additional opportunities in lung and blood stream infections • Broad spectrum gyrase program entering clinic in 2013 • Significant potential near-term catalysts • Strong balance sheet 17
  18. The Future of Anti-Infectives Baird Healthcare Conference September 5, 2012 18
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