Halozyme Therapeutics, Inc. · NASDAQ:HALO

Halozyme Therapeutics — Investor Presentation (January 2015)

28 slides from Halozyme Therapeutics's investor presentation, Jan 12, 2015

  1. Slide 1: The Next Chapter Begins: Creating Value through Growth

    The Next Chapter Begins: Creating Value through Growth Corporate Overview January 13, 2015 Helen Torley, M.B. Ch. B., M.R.C.P. President and Chief Executive Officer 1 EXHIBIT 99.2

  2. Slide 2: Forward-Looking Statements

    Forward-Looking Statements All of the statements in this presentation that are not statements of historical facts constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of such statements include future product development and regul

  3. Slide 3: Halozyme: Two Potential Drivers of Future Growth and Value

    Halozyme: Two Potential Drivers of Future Growth and Value 3 ENHANZE™ (rHuPH20) n CH2 CH2 OCH2 O CH3 N H O CH2 CH2 OO CH2 CH3 N H O n CH2 CH2 OO CH2 CH3 N O H n n CH2 CH2 OCH2 O CH3 N H O CH2 CH2 OO CH2 CH3 N O H n PEGylated form of rHuPH20 Investigational new drug in phase 2 development PEGPH20

  4. Slide 4: Significant Value Creating Progress in 2014

    UUUSS US  US Regulatory Validation – Baxter’s HYQVIA [(Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase)] approval by FDA in September 2014  Commercial Validation – Rapid adoption and market conversion to Herceptin SC (trastuzumab) – Janssen Global License agreement within

  5. Slide 5: 2015 Financial Guidance

    2015 Financial Guidance 5 2015E Comments Net Revenues $85M - $95M Royalties, sales of rHuPH20 to partners, Hylenex® recombinant (hyaluronidase human injection) sales and collaboration revenues Operating Expenses1 $145M - $155M R&D driven by clinical trial enrollment Cash Burn $35M - $45M Does not in

  6. Slide 6: PEGPH20 (PEGylated form of rHuPH20)

    PEGPH20 (PEGylated form of rHuPH20) 6

  7. Slide 7: PEGPH20 Goal: Improving Targeting of Co-Administered Cancer Drugs

     PEGPH20 – Investigational new drug – Intended to target hyaluronan (HA), a key component of the tumor microenvironment (TME) – Potential to increase tumor-selective access of co-administered anticancer therapy into tumors that accumulate high levels of hyaluronan (HAhigh)  Encouraging early clini

  8. Slide 8: Targeting Large Markets With Poor Survival Rates

    1L Stage IV Pancreatic Cancer 2L Stage IIIB/IV Non Small Cell Lung Cancer Annual Incidence (US and EU 5) ~100,000 ~80,000 Estimated % with HAhigh 40-60% 35-45% 5 Year Survival 5% 16.8% Overall Survival with Current Standard of Care 8.5 months (Abraxane® plus gemcitabine) 7-8 months (docetaxel, Alimt

  9. Slide 9: Study 202: Ongoing Trial of PEGPH20 with Abraxane and Gemcitabine

    Study 202: Ongoing Trial of PEGPH20 with Abraxane® and Gemcitabine PEGPH20 + Abraxane® + gemcitabine Abraxane® + gemcitabine Stage IV Metastatic PDA N=260 KPS 70-100 Biopsy Tissue Primary endpoints: PFS Rate of TE events Secondary endpoints: PFS by HA level ORR OS H A L O -2 0 2 Total Sites 44 (US o

  10. Slide 10: Study History and Status

    Study 202 History and Status Clinical Hold: based on DMC finding of potential imbalance in TE events between treatment arms Protocol Amendment  Add ~100 patients  2:1 PAG to AG randomization  Exclude high Thromboembolic Event risk patients  Add LMWH to both arms  Additional primary endpoint: ev

  11. Slide 11: Results: Early Data Suggest Higher ORR with PEGPH20

    Results: Early Data Suggest Higher ORR with PEGPH20 Particularly in HAhigh  ORR based on independent, blinded central review  Safety data presented on slides 14 and 15 MPACT Study ORR Results: Von Hoff D. NEJM. 2013,369:1691 – Abraxane® plus gemcitabine, 23% vs gemcitabine, 7% Study 202 Interim An

  12. Slide 12: Early Data Suggests Increased PFS In HAhigh Patients

    Progression Free Survival Study 202 Interim Results: Analysis Population No. with events / total evaluated patients; median PFS in months HR P-value PAG vs AG PAG arm n=61 AG arm n=45 Safety w/HA 34/61; 5.5 30/45; 4.8 0.64 0.086 HA High 12/25; 9.2 15/23; 4.3 0.38 0.031 HA Low 22/36; 4.8 15/22; 5.6 0

  13. Slide 13: Study 202: Interim ORR and PFS Data Summary

    ORR: 71% PFS: 9.2 months ORR: 29% PFS: 4.3 month ORR: 50% PFS: 4.8 months ORR: 50% PFS: 5.6 months Study 202: Interim ORR and PFS Data Summary PAG AG High HA Low HA ORR data through April 9th, 2014 and reflects PAG or AG treatment PFS data through December 5th, 2014 and reflects PAG  AG treatment i

  14. Slide 14: Overall Safety Profile

    Overall Safety Profile Treatment Related AEs >25% Patients PAG N=74 Patients, n (%) AG N=61 Patients, n (%) Preferred Term Grade 3+ Any Grade Grade 3+ Any Grade Any AE 61 (82.4) 73 (98.6) 45 (73.8) 57 (93.4) Fatigue 13 (17.6) 50 (67.6) 11 (18.0) 39 (63.9) Nausea 5 (6.8) 41 (55.4) 2 (3.3) 27 (44.3) A

  15. Slide 15: Study 202: Stage 1 Interim Results Thromboembolic Events

    Parameters PAG AG Patients, N 74 61 Patients with TEs, n (%) 31 (41.9) 15 (24.6) Patients with PE, n (%) 16 (21.6) 6 (9.8) Patients with DVT, n (%) 16 (21.6) 9 (14.7) Patients with Arterial TE, n (%) 7 (9.4) 0 Grade 1 and 2 events, (% of N) 21 15 Grade ≥3 events (% of N) 23 5 Study 202: Stage 1 Inte

  16. Slide 16: Pancreatic Cancer: Planned Next Steps

    Pancreatic Cancer: Planned Next Steps  Complete enrollment – Study 202 in 2H 2015 – SWOG Study S1313: PEGPH20 in combination with mFOLFIRINOX  Meet with FDA (end Q1 target) – Discuss potential registration-seeking trial in HAhigh Stage 4 Pancreatic Ductal Adenocarcinoma patients  Gain EMA scienti

  17. Slide 17: Non Small Cell Lung Cancer: Significant Unmet Medical Need

    Non Small Cell Lung Cancer: Significant Unmet Medical Need  Over 160K newly diagnosed 1L and 84K 2L patients annually (US & 5EU)  Survival times remain low with no curative therapy  Immunotherapy may offer hope for some but opportunity remains to do more 2L Chemo [84,000] NSCLC [375,000] <Stage I

  18. Slide 18: Non Small Cell Lung Cancer: Two PEGPH20 Trials Planned

    Non Small Cell Lung Cancer: Two PEGPH20 Trials Planned  Over 160K newly diagnosed 1L and 84K 2L patients annually (US & 5EU)  Survival times remain low with no curative therapy  Immunotherapy may offer hope for some but opportunity remains to do more 2L Chemo [84,000] NSCLC [375,000] <Stage IIIB

  19. Slide 19: Phase 1b/2 PRIMAL Study in NSCLC Initiated

    Phase 1b/2 PRIMAL Study in NSCLC Initiated Dose escalation PEGPH20 + docetaxel 75mg/m2 N=Up to 240 Schedule A PEGPH20 Q21d Schedule B PEGPH20 2/W Q21d PEGPH20 + docetaxel docetaxel N = 170 HAhigh 1:1R Phase 1b Phase 2 PEGPH20 + docetaxel in HAhigh Platinum Failed NSCLC Patients Total Sites Phase 1b

  20. Slide 20: Exploring Combination of PEGPH20 with Anti-PD1 Antibody

    Dose Escalation Endpoints: DLT, MTD, RP2D, PK of PEGPH20 and safety profile Dose Expansion Phase 1b expansion end points:  ORR, DCR, DOR, PFS  Plan to initiate study Q3 2015 Exploring Combination of PEGPH20 with an Anti- PD1 Antibody in HAhigh Tumors—HALO 107-101 Dose escalation PEGPH20 + PD1 Inhi

  21. Slide 21: Key Projected Program and Data Milestones

    Key Projected Program and Data Milestones FDA Discussion Registration-seeking Trial Stage1 202 Efficacy and Safety Data Q1 2016 Pancreatic Cancer NSCLC Additional Cancer Q4 2015 Q3 2015 Q2 2015 Q1 2015 Complete Enrollment 202 Stage2 Results Study 202 Target for First Patient Enrolled New Trial First

  22. Slide 22: ENHANZE Technology

    ENHANZE™ Technology Halozyme

  23. Slide 23: Baxter's HYQVIA: First U.S. Approved BLA Utilizing ENHANZE

    HYQVIA [(Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase)]  Approved September 2014 following 15-1 vote by Advisory Committee on positive risk:benefit  Differentiated subcutaneous therapy for Primary Immunodeficiency Disease (PID) in Adults  rHUPH20 pre-administration fa

  24. Slide 24: Revenue-Driving ENHANZE Platform Recognized By 3 of Top 5 Pharma/Biotech

    + UP TO 6 ADDITIONAL TARGETS PCSK-9 Rivipansel + UP TO 2 ADDITIONAL TARGETS Royalties from Top-line Sales plus Milestones UP TO 5 EXCLUSIVE TARGETS Revenue-Driving ENHANZE™ Platform Recognized By 3 of Top 5 Pharma/Biotech Companies 23

  25. Slide 25: Herceptin and MabThera/Rituximab Revenue Opportunity

    NOTE: 1) Financial information obtained from Roche investor update (January 30, 2014). Amounts presented in $US Dollars (1 CHF = 1.0794 $USD). Rounded. 2) Revenues as a percentage of sales for Herceptin and Mabthera/Rituxan were obtained from Roche investor update (January 30, 2014). 3) Information

  26. Slide 26: Herceptin SC and MabThera SC Launch Progress

    Herceptin SC (trastuzumab)  Launched September 2013  New filings and approvals ongoing  Recent Reimbursement approved in France2  92% preference by patients3  Demonstrated to reduce HCP and patient time4 MabThera SC (rituximab)  Launched June 2014 in initial European Countries  Demonstrated t

  27. Slide 27: Just At The Start of The Royalty Ramp

    $799 $1,700 $2,900 $0 $1,000 $2,000 $3,000 $4,000 1Q14 Royalties (Reflects Oct-Dec 2013 Sales) 2Q14 Royalties (Reflects Jan-Mar 2014 Sales) 3Q14 Royalties (Reflects April-June 2014 Sales) Royalties (As Reported by HALO) Royalty Revenues (in $000)1,2,3 Sept 2013 Oct 2013 Nov 2013 Dec 2013 Jan 2014 Fe

  28. Slide 28: Key 2015 PEGPH20 Milestones and ENHANZE Goals

    PEGPH20 Pancreatic Cancer  Present Study 201 (Phase 1b) final results - ASCO-GI  FDA Discussion (Regarding registration-seeking trial)  Complete Study 202 (Phase 2) Enrollment  Initiate Registration-Seeking Clinical Trial January 2015 1H 2015 2H 2015 4Q2015-1Q2016 PEGPH20 Non-Small Cell Lung Can

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