Halozyme Therapeutics, Inc. · NASDAQ:HALO
Halozyme Therapeutics — Q2 2015 Earnings Presentation
18 slides from Halozyme Therapeutics's earnings presentation, Aug 10, 2015
Slide 1: 2nd Quarter 2015 Earnings Call Presentation
2nd Quarter 2015 Earnings Call Presentation August 10, 2015 1
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
Slide 3: Business Update & Review
2nd Quarter 2015 Earnings Call Presentation Business Update & Review August 10, 2015 Helen Torley, M.B. Ch. B., M.R.C.P. President and Chief Executive Officer 3
Slide 4: Two-Pillar Strategy For Growth
Two-Pillar Strategy For Growth ENHANZE™ Platform PEGPH201 (rHuPH20) Licensing/Royalty Agreements Investigational New Oncology Based On Proprietary Enzyme Drug In Phase 2 Development O H N O CH2 CH2 O CH2 H3C n O H N O O CH2 CH2 O CH2 N H3C n H CH2 CH2 CH2 O O nCH3 O N H O O CH2 CH2 O CH2 N H3C n H C
Slide 5: Study 202: Ongoing Trial of PEGPH20 with ABRAXANE and Gemcitabine
Study 202: Ongoing Trial of PEGPH20 with ABRAXANE® and Gemcitabine Study evaluating PEGPH20 with ABRAXANE® (nab-paclitaxel) and Gemcitabine in Stage IV metastatic pancreatic ductal adenocarcinoma patients PEGPH20 + ABRAXANE® + Primary endpoints: Stage IV gemcitabine (PAG) Progression Free Survival (
Slide 6: Study 202: Interim Results Presented at ASCO 2015 (PFS)
Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO 20151 PFS in HA-High Patients 100 PAG K -M E s tim a te o f P ro g re s s io n AG p=0.05 F re e S u rv iv a l (% ) PAG HR 9.2 months 50 0.39 (0.15, 1.04) AG 4.3 months 0 0 2 4 6 8 10 12 14 S tu d y D u ra tio
Slide 7: Study 202: ORR and DoR in HA-High Patients
Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO 20151 ORR and DoR in HA-High Patients (Blinded Central Review) PAG AG Responders / Total (%); Responders / Total (%); Population Duration (months) Duration (months) P-value Treated 30 / 74 (41%); 7.4 21 / 61 (
Slide 8: Study 202: OS in HA-High Patients
Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO 20151 OS in HA-High Patients 100 PAG AG K -M E s tim a te o f O v e ra ll PAG S u rv iv a l (% ) 12 months HR 50 0.62 (0.26, 1.46) AG 9 months 0 0 2 4 6 8 10 12 14 16 18 S tu d y D u r a tio n ( m o n th s ) A
Slide 9: Study 202: Stage 1 Overall Safety Profile
Study 202: Randomized Phase 2 Study in Pancreatic Cancer Stage 1 Overall Safety Profile Treatment Related AEs >25%1 PAG AG N=74 N=61 Patients, n (%) 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.
Slide 10: Study 202: Interim Safety Results, TE Events Reduced With Enoxaparin
Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Safety Results Presented at ASCO 20151 Stage 2 Data: TE Events Reduced With Enoxaparin Enoxaparin Prophylaxis TE Event Rate Prophylaxis Dose PAG AG Stage 1 N/A 42% 25% (through 05Dec2014) (n=74) (n=61) 40 mg/day; or, 28% 29% 40 mg/day
Slide 11: PEGPH20 in Pancreatic Cancer Program Progress
PEGPH20 in Pancreatic Cancer Program Progress u Feedback from European Medicines Agency (EMA) – Supportive of the proposed patient population, and overall trial design, including evaluating only high-HA patients – OS is the preferred primary endpoint – A conditional marketing authorization (CMA) co
Slide 12: New Clinical Collaboration for PEGPH20
New Clinical Collaboration for PEGPH20 u Clinical collaboration will explore whether HALAVEN® (eribulin) in combination with PEGPH20 can improve ORR in first line HER2-negative metastatic breast cancer patients with high-HA – Estimate 30,000 to 35,000 patients in the U.S.1 u Each company will co-f
Slide 13: ENHANZE Technology: Partnered Program Update
ENHANZE™ Technology: Partnered Program Update u Herceptin SC (trastuzumab)1 – Currently launched in 44 countries – Conversion rate already exceeds 30% in these countries u Strong momentum for HYQVIA in the U.S.2 – ~2,300 adult PID Sub-Q patients using HYQVIA or 15% share of Sub-Q immunoglobulin se
Slide 14: Financial Review
2nd Quarter 2015 Earnings Call Presentation Financial Review August 10, 2015 Laurie Stelzer Chief Financial Officer 14
Slide 15: 2nd Quarter 2015 Financial Highlights
2nd Quarter 2015 Financial Highlights1 $ U.S. in Millions (unaudited) 2Q2015 2Q2014 % Change Total Revenues $43.4 $18.4 136% Royalty Revenue $6.4 $1.7 278% Bulk rHuPH20 $7.7 $6.0 28% Sales Hylenex® $4.2 $3.0 40% recombinant Collaboration $24.7 $7.2 243% Revenues NOTE: 1) Dollar amounts and percentag
Slide 16: 2nd Quarter 2015 Financial Highlights
2nd Quarter 2015 Financial Highlights1 $ U.S. in Millions, except EPS (unaudited) 2Q2015 2Q2014 % Change Total Revenues $43.4 $18.4 136% R&D $21.2 $18.6 14% SG&A $9.8 $8.8 11% Net Income (Loss) $3.0 ($16.3) -- EPS $0.02 ($0.13) -- Cash position 2Q2015: $140.7M Net Cash increase in 2Q2015: $12.2M NOT
Slide 17: New 2015 Financial Guidance
New 2015 Financial Guidance Previous New 2015E Guidance1 2015E Guidance Net Revenues $85M - $95M $110M - $115M Operating Expenses $145M - $155M $160M - $170M Cash Burn $35M - $45M $20M - $30M Note 1) Previous guidance provided January 7, 2015. 17
Slide 18: Upcoming Halozyme Goals
Upcoming Halozyme Goals u Present interim results from Study 202 at ASCO 2015 Completed √ u Sign partnership agreement for companion diagnostic Completed √ PEGPH20 Pancreatic u Discuss Phase 3 study with the European Medicines Agency Completed √ Cancer u Complete Study 202 (Phase 2) enrollment E
Halozyme Therapeutics — Q2 2015 Earnings Presentation on 6ix