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The Future of Anti-Infectives




2012 Credit Suisse Healthcare Conference

November 14, 2012




                                                      1
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
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
   – De-risked asset with high efficacy & superior safety


• Bayer collaboration to generate additional clinical data


• Broad spectrum gyrase program entering clinic in 2013


• Significant potential near-term catalysts


                                                                  3
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
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
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
Physician attitude on vancomycin is changing
   Percent of physicians reporting decreased or increased prescriptions




                                                                       51%
                                                              39%
More




                        9%
                                                               8%       6%
Less




                       48%




               Vancomycin                                     Zyvox   Cubicin
Source: AMR - Hospital Insight Series, US Data, August 2011
                                                                                7
Tedizolid: highly differentiated oxazolidinone

       Tedizolid           Linezolid (Zyvox)




  Week 1       Week 2     Week 1       Week 2




                                                 8
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
Tedizolid Attributes Align Well With Market Need


                                                        Key unmet needs for antibacterials
                                                              Activity against Gram-
                                                               negative pathogens
                       Increasing level of importance


                                                                 Activity against
                                                               resistant pathogens

                                                               Improved safety and
                                                                 tolerability profile
                                                                 Shorter treatment
                                                                                             Tedizolid
                                                                     courses
                                                                   Lower cost of
                                                                     therapy

                                                                   Oral/IV switch




Source: Datamonitor.                                                                                     10
Tedizolid Profile Shifts Share From Both Vancomycin and Zyvox
                                         Allocation of Common Agents for Treatment of MRSA Overall
                                                                                      (n=165)


                            Original
                            Allocation
                                             50%               12%                21%                 7%                8%                 3%

  50%
                                           38%
   % Patients Prescribed




                            29%

                                                                                                                                                                       Future Usage
                                                                                    11%
                                                                9%
                                                                                                         5%                   6%
                                                                                                                                                   3%


                                                                                                                             -2pp                 0pp
                                                               -3pp                                     -2pp
                                                                                                                                                                       Change from
                                           -12pp                                   -10pp
                                                                                                                                                                       Current

 -25%
                           Tedizolid     Vancomycin          Cubicin               Zyvox               Teflaro              Tygacil              Other


                                            D13: Now, please think about your prescribing for these same patients if Product X were also available, considering the fact that trials would be
Trius Quantitative Study, 2012              ongoing for hospital-acquired pneumonia at the time Product X becomes available.                                                                11
Generic Linezolid Has a Modest Impact on Tedizolid
                                         Impact of Generic Linezolid on Treatment of MRSA ABSSSI
                                                                                    (n=165)



           50%



                                                            40%
                                                                   38%
                                                                                Branded Zyvox: Tedizolid Cost per Day of Therapy Same as Zyvox
           % Physicians




                                                                                Generic Linezolid: Tedizolid Cost per Day of Therapy Same as Zyvox
                          29%


                                23%




                                               14%
                                                                                                 11%


                                                                               7%     7%               6%           5%                 5%
                                                                                                                          5%                  5%               2%
                                                                                                                                                         3%

                0%
                          Tedizolid    Generic Linezolid    Vancomycin          Cubicin            Zyvox             Teflao             Tygacil            Other




                                      C2: Now, please think about your prescribing for these same patients if Product X were also available, using your previous answers as a
                                      reference.
                                      E3: How would the availability of generic linezolid impact your use of Product X in your next 20 MRSA ABSSSI patients at that point? Please
Trius Quantitative Study, 2012        assume that the price of Product X would be the same as branded Zyvox (linezolid) per day.                                                    12
Phase 3 trial design: ESTABLISH-1 (oral), ESTABLISH-2 (IV/PO)
              Non-inferiority trail design vs Linezolid
                                  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



                                                                        13
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                                  14
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
                                                                        15
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
                                                                                                  16
Clinical studies show DDI advantage over linezolid
    No monoamine oxidase mediated interactions


Phase 1 - Tyramine:
• Tedizolid similar to placebo. No dietary restrictions necessary
• Linezolid induces 5-fold increase in tyramine sensitivity

Phase 1 - Noradrenergic:
• Tedizolid similar to placebo. No increase in mean blood pressure
• Linezolid induces 113% increase in mean blood pressure




                                                                     17
Tedizolid showed no interactions with SSRIs
       Mouse Head Twitch Study




                                               69
         13              13
           Placebo       Tedizolid             Linezolid
                     (30X human exposure)   (1X human exposure)




                                                                  18
Differences between ESTABLISH-1 and 2

• IV to oral switch: minimum 1-day of IV dosing
   – Slightly higher exposure for tedizolid IV (~8%)
   – No differences expected in efficacy or safety


• Patient demographics
   – ESTABLISH-1: 80% US; ESTABLISH-2: 50% US
     • X-US patients have statistically larger lesions (ESTABLISH-1)
     • Tedizolid response rate vs linezolid enhanced in larger lesions




                                                                         19
Rapid efficacy in severe cellulitis

     Screen           Day 3           Day 10




    337cm2           0 cm2            0 cm2

                                               20
High cellulitis efficacy at both FDA + EMA endpoints*
                     Difficult to treat deep tissue infections
        Tedizolid
        Linezolid                                        98%


                                                         91%



                      82%

                      78%




                   FDA Endpoint                    EMA Endpoint


*Clinical cure at days 17-21                                      21
Tedizolid on track toward market

• ESTABLISH-2 enrollment completion: Q4 2012


• ESTABLISH-2 top line data: H1 2013


• ABSSSI NDA filing: H2 2013


• Potential NDA approval: mid 2014*




* With Priority Review afforded by the GAIN Act
                                                  22
Gyrase: broad spectrum antibacterial program

• Potent activity against gram negative and gram positive pathogens


• Novel chemical class, broad IP rights


• Funded through Phase 1 from 5-year $28M NIAID contract


• Expected to enter clinic 2013


• First data roll out at ICAAC (9/12): 14 posters, 1 oral presentation




                                                                     23
Strong balance sheet



 Cash and Marketable Securities (9/30/12)   $71M


 Long-term Debt (9/30/12)                   $0M


 Shares Outstanding (11/1/12)               39.4M




                                                    24
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
   – De-risked asset with high efficacy & superior safety


• Bayer collaboration to generate additional clinical data


• Broad spectrum gyrase program entering clinic in 2013


• Significant potential near-term catalysts


                                                                  25
The Future of Anti-Infectives




2012 Credit Suisse Healthcare Conference

November 14, 2012




                                                      26

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Trius nov12confpresentation

  • 1. The Future of Anti-Infectives 2012 Credit Suisse Healthcare Conference November 14, 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 – De-risked asset with high efficacy & superior safety • Bayer collaboration to generate additional clinical data • Broad spectrum gyrase program entering clinic in 2013 • Significant potential near-term catalysts 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 prescriptions 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. Tedizolid Attributes Align Well With Market Need Key unmet needs for antibacterials Activity against Gram- negative pathogens Increasing level of importance Activity against resistant pathogens Improved safety and tolerability profile Shorter treatment Tedizolid courses Lower cost of therapy Oral/IV switch Source: Datamonitor. 10
  • 11. Tedizolid Profile Shifts Share From Both Vancomycin and Zyvox Allocation of Common Agents for Treatment of MRSA Overall (n=165) Original Allocation 50% 12% 21% 7% 8% 3% 50% 38% % Patients Prescribed 29% Future Usage 11% 9% 5% 6% 3% -2pp 0pp -3pp -2pp Change from -12pp -10pp Current -25% Tedizolid Vancomycin Cubicin Zyvox Teflaro Tygacil Other D13: Now, please think about your prescribing for these same patients if Product X were also available, considering the fact that trials would be Trius Quantitative Study, 2012 ongoing for hospital-acquired pneumonia at the time Product X becomes available. 11
  • 12. Generic Linezolid Has a Modest Impact on Tedizolid Impact of Generic Linezolid on Treatment of MRSA ABSSSI (n=165) 50% 40% 38% Branded Zyvox: Tedizolid Cost per Day of Therapy Same as Zyvox % Physicians Generic Linezolid: Tedizolid Cost per Day of Therapy Same as Zyvox 29% 23% 14% 11% 7% 7% 6% 5% 5% 5% 5% 2% 3% 0% Tedizolid Generic Linezolid Vancomycin Cubicin Zyvox Teflao Tygacil Other C2: Now, please think about your prescribing for these same patients if Product X were also available, using your previous answers as a reference. E3: How would the availability of generic linezolid impact your use of Product X in your next 20 MRSA ABSSSI patients at that point? Please Trius Quantitative Study, 2012 assume that the price of Product X would be the same as branded Zyvox (linezolid) per day. 12
  • 13. Phase 3 trial design: ESTABLISH-1 (oral), ESTABLISH-2 (IV/PO) Non-inferiority trail design vs Linezolid 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 13
  • 14. 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 14
  • 15. 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 15
  • 16. 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 16
  • 17. Clinical studies show DDI advantage over linezolid No monoamine oxidase mediated interactions Phase 1 - Tyramine: • Tedizolid similar to placebo. No dietary restrictions necessary • Linezolid induces 5-fold increase in tyramine sensitivity Phase 1 - Noradrenergic: • Tedizolid similar to placebo. No increase in mean blood pressure • Linezolid induces 113% increase in mean blood pressure 17
  • 18. Tedizolid showed no interactions with SSRIs Mouse Head Twitch Study 69 13 13 Placebo Tedizolid Linezolid (30X human exposure) (1X human exposure) 18
  • 19. Differences between ESTABLISH-1 and 2 • IV to oral switch: minimum 1-day of IV dosing – Slightly higher exposure for tedizolid IV (~8%) – No differences expected in efficacy or safety • Patient demographics – ESTABLISH-1: 80% US; ESTABLISH-2: 50% US • X-US patients have statistically larger lesions (ESTABLISH-1) • Tedizolid response rate vs linezolid enhanced in larger lesions 19
  • 20. Rapid efficacy in severe cellulitis Screen Day 3 Day 10 337cm2 0 cm2 0 cm2 20
  • 21. High cellulitis efficacy at both FDA + EMA endpoints* Difficult to treat deep tissue infections Tedizolid Linezolid 98% 91% 82% 78% FDA Endpoint EMA Endpoint *Clinical cure at days 17-21 21
  • 22. Tedizolid on track toward market • ESTABLISH-2 enrollment completion: Q4 2012 • ESTABLISH-2 top line data: H1 2013 • ABSSSI NDA filing: H2 2013 • Potential NDA approval: mid 2014* * With Priority Review afforded by the GAIN Act 22
  • 23. Gyrase: broad spectrum antibacterial program • Potent activity against gram negative and gram positive pathogens • Novel chemical class, broad IP rights • Funded through Phase 1 from 5-year $28M NIAID contract • Expected to enter clinic 2013 • First data roll out at ICAAC (9/12): 14 posters, 1 oral presentation 23
  • 24. Strong balance sheet Cash and Marketable Securities (9/30/12) $71M Long-term Debt (9/30/12) $0M Shares Outstanding (11/1/12) 39.4M 24
  • 25. 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 – De-risked asset with high efficacy & superior safety • Bayer collaboration to generate additional clinical data • Broad spectrum gyrase program entering clinic in 2013 • Significant potential near-term catalysts 25
  • 26. The Future of Anti-Infectives 2012 Credit Suisse Healthcare Conference November 14, 2012 26