Third Quarter 2015 Earnings Call. November 9, 2015

Transcription

1 Third Quarter 2015 Earnings Call November 9, 2015

2 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 Examples of such statements include future product development and regulatory events and goals, anticipated clinical trial results and strategies, product collaborations, our business intentions and financial estimates and results. These statements are based upon management s current plans and expectations and are subject to a number of risks and uncertainties which could cause actual results to differ materially from such statements. A discussion of the risks and uncertainties that can affect these statements is set forth in the Company s annual and quarterly reports filed from time to time with the Securities and Exchange Commission under the heading Risk Factors. The Company disclaims any intention or obligation to revise or update any forward-looking statements, whether as a result of new information, future events, or otherwise. 1

3 Two-Pillar Strategy For Growth ENHANZE Platform (rhuph20) Licensing/Royalty Agreements Based On Proprietary Enzyme PEGPH20 1 Investigational New Oncology Drug In Phase 2 Development O H N O CH 2 CH 2 O CH 2 H 3 C n O H N O CH 2 CH 2 O CH 2 H 3 C n N H O CH 2 CH 2 CH 2 O O n CH 3 O O CH 2 CH 2 O CH 2 H 3 C n N H N H O CH 2 CH 2 CH 2 O O n CH 3 PEGylated form of rhuph20 NOTE: 1) PEGPH20 is an investigational new drug. Safety and efficacy profile have not been established; it is not currently available for commercial distribution. 2

4 Study 202: Ongoing Trial of PEGPH20 with ABRAXANE and Gemcitabine HALO-202 Stage IV Metastatic PDA N=260 KPS PEGPH20 + ABRAXANE + gemcitabine (PAG) ABRAXANE + gemcitabine (AG) Primary endpoints: Progression Free Survival (PFS) Rate of TE events Secondary endpoints: PFS by Hyaluronan (HA) level Overall Response Rate (ORR) Overall Survival (OS) Total Sites 45 (US only) First patient enrolled March 2013 Expected last patient enrolled End of 2015 Expected top line data Event driven, 2H 2016 HA status Retrospective assessment at central lab of tissue biopsy with HTI601/StainMap 3

5 Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO PFS in HA-High Patients K-M Estimate of Progression Free Survival (% ) AG 4.3 months p=0.05 PAG AG PAG 9.2 months HR 0.39 (0.15, 1.04) At Risk Study Duration (months) PAG AG Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 4

6 Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO ORR and DoR in HA-High Patients (Blinded Central Review) Population PAG Responders / Total (%); Duration (months) AG Responders / Total (%); Duration (months) P- value Treated 30 / 74 (41%); / 61 (34%); Treated w/ha Data 26 / 61 (43%); / 45 (31%); HA-High* 12 / 23 (52%); / 21 (24%); HA-Low 14 / 38 (37%); / 24 (38%); *1 CR with DoR of 7.4 months ORR in HA-high through clinical hold April 2014: 11/15 (73%) PAG vs. 4/15 (27%) AG, p=0.01 Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 5

7 Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO OS in HA-High Patients K-M Estimate of Overall S urvival (% ) AG 9 months PAG AG PAG 12 months HR 0.62 (0.26, 1.46) At Risk Study Duration (months) PAG AG Data include 12 of 23 PAG patients who discontinued PEGPH20 and received AG alone after clinical hold in April 2014 Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 6

8 Study 202: Stage 1 Overall Safety Profile Treatment Related AEs >25% 1 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) 42 (68.9) Nausea 5 (6.8) 41 (55.4) 2 (3.3) 27 (44.3) Anemia 14 (18.9) 31 (41.9) 10 (16.4) 32 (52.5) Edema peripheral 2 (2.7) 43 (58.1) 4 (6.6) 19 (31.1) Diarrhea 5 (6.8) 31 (41.9) 2 (3.3) 24 (39.3) Alopecia 0 24 (32.4) 0 25 (41.0) Decreased appetite 4 (5.4) 26 (35.1) 2 (3.3) 15 (24.6) Muscle spasms 6 (8.1) 41 (55.4) 0 1 (1.6) Platelet count decreased 5 (6.8) 22 (29.7) 4 (6.6) 18 (29.5) Vomiting 4 (5.4) 23 (31.1) 0 16 (26.2) Neutropenia 18 (24.3) 24 (32.4) 9 (14.8) 11 (18.0) Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 7

9 Study 202: Stage 2 Data: TE Events Reduced With Enoxaparin Prophylaxis Interim Results Presented at ASCO Enoxaparin Prophylaxis Dose PAG TE Event Rate AG Stage 1 (through 05Dec2014) N/A 42% (n=74) 25% (n=61) Stage 2 (through 20May2015) 40 mg/day; or, 40 mg/day increased to 1 mg/kg/day Started on 1 mg/kg/day Stage 2 (total patients) 28% (n=18) 0% (n=20) 13% (n=38) 29% (n=7) 10% (n=10) 18% (n=17) Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006). 8

10 Phase 3 Design: HALO-301 Stage IV Metastatic Pancreatic Ductal Adenocarcinoma N=420 PEGPH20 + ABRAXANE + gemcitabine (PAG) ABRAXANE + gemcitabine (AG) + placebo Primary endpoints: Progression-Free Survival (PFS) Overall Survival (OS) Patients prospectively screened, included based on high-ha tumors Randomized (2:1 PAG:AG), double-blind, placebo-controlled, global study Stratified by geographic region Interim analysis when target number of PFS events reached 9

11 PEGPH20 in Pancreatic Cancer: Upcoming Milestones Milestone Target Date Complete Patient Enrollment: Study 202 Stage 2 End of 2015 Data on Thromboembolic Event Rate: Study 202 Early 2016 Finalize and announce methodology to prospectively identify High-HA population Early 2016 Study 301 Initiated End of Q Present mature Progression-Free Survival, Response Rate, Duration of Response data: Study 202 2H

12 Phase 1b Design: HALO-107 Relapsed/ Refractory Stage IIB/IV Non-Small Cell Lung Cancer (NSCLC); Recurrent Locally Advanced or Metastatic Gastric Adenocarcinoma Dose Escalation PEGPH20 weekly KEYTRUDA Q3wks 3+3 Design N=up to 30 Dose Expansion High HA N=51 Study endpoints: Dose Escalation: - Dose Limiting Toxicities - Maximum Tolerated Dose Dose Expansion: - Overall Response Rate - Duration of Response - Progression-Free Survival NSCLC: Post- Platinum N=29 Gastric: Prior chemotherapy, N=22 Halozyme sponsored trial: PEGPH20 + KEYTRUDA (pembrolizumab) First patient dosed Nov Gastric cancer patients in dose expansion selected for PDL1 positivity pending diagnostic availability Overall Response Rate measured per RECIST 1.1 criteria 11

13 ENHANZE Technology: Partnered Program Update Herceptin SC (trastuzumab) 1 Currently launched in >44 countries Herceptin SC sales account for more than 35% of the total Herceptin sales in the EU HYQVIA 2 Run-rate sales now exceeding $100M More than 50% U.S. patients converting from competitive therapies; ~25 % newly diagnosed patients Daratumumab First dose in Phase 1b study of a subcutaneous formulation of in multiple myeloma patients Rivipansel First dose in Phase 1 study of a subcutaneous formulation for vaso-occlusive crisis sickle cell patients Humira 3 Delivery enhancements may help reduce the number of induction injections at higher doses and deliver additional performance benefits. 1) Information from Roche investor updates (April 22 and Oct. 21, 2015). 2) Information from Baxalta investor update (Oct. 29, 2015). 3) Information from AbbVie investor update (Oct. 30, 2015) 12

14 Third Quarter 2015 Financial Highlights 1 $ U.S. in Millions (unaudited) 3Q2015 3Q2014 % Change Total Revenue $20.8 $ % Royalty Revenue $8.3 $ % Bulk rhuph20 Sales $6.3 $5.8 9% Hylenex recombinant $3.9 $3.6 8% Collaboration Revenue $2.2 $2.1 5% NOTE: 1) Dollar amounts and percentages, as presented, are rounded. 13

15 Third Quarter 2015 Financial Highlights 1 $ U.S. in Millions, except EPS (unaudited) 3Q2015 3Q2014 % Change Total Revenues $20.8 $ % R&D $27.6 $ % SG&A $10.2 $8.6 19% Net Income (Loss) ($24.5) ($20.3) -- EPS ($0.19) ($0.16) -- Cash and marketable securities: $123.7 NOTE: 1) Dollar amounts and percentages, as presented, are rounded. 14

16 Financial Guidance for 2015 Financial Guidance Net Revenues $110M to $115M Operating Expenses $160M to $170M Cash Burn $20M to $30M Year-end Cash Balance $105M to $115M 15

17 Upcoming Milestones PEGPH20 Pancreatic Cancer Complete Study 202 (Phase 2) target enrollment Initiate Study 301 (Phase 3) clinical trial End of 2015 End of 1Q2016 PEGPH20 Non-Small Cell Lung Cancer Advance through dose-finding portion of Phase 1b study of PEGPH20 in combination with docetaxel Ongoing PEGPH20 + Immunotherapy in NSCLC and Gastric Cancer Advance through dose-finding portion of Phase 1b study of PEGPH20 in combination with KEYTRUDA (pembrolizumab) Ongoing PEGPH20 Breast Initiate Phase 1b/2 trial using PEGPH20 in combination with HALAVEN (eribulin) Q ENHANZE Goals Increase number of products entering the clinic Increase number of partnerships Ongoing 16

18 Third Quarter 2015 Earnings Call November 9, 2015