2nd quarter 2015 earnings call presentation · 2nd quarter 2015 earnings call presentation business...

2nd Quarter 2015 Earnings Call Presentation August 10, 2015

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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 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.

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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

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Two-Pillar Strategy For Growth

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ENHANZE™ Platform (rHuPH20) PEGPH201

nCH2 CH2 OCH2 O

CH3

N

H

OCH2 CH2 OO CH2

CH3

NH

O

n

CH2 CH2 OO CH2CH3

N

O H

n

nCH2 CH2 OCH2 O

CH3

N

H

OCH2 CH2 OO CH2

CH3

N

O H

n

PEGylated form of rHuPH20

Licensing/Royalty Agreements Based On Proprietary Enzyme

Investigational New Oncology Drug In Phase 2 Development

NOTE: 1) PEGPH20 is an investigational new drug. Safety and efficacy profile have not been established; it is not currently available for commercial distribution.

Study 202: Ongoing Trial of PEGPH20 with ABRAXANE® and Gemcitabine

PEGPH20 + ABRAXANE® + gemcitabine (PAG)

ABRAXANE® + gemcitabine (AG)

Stage IV Metastatic

PDA N=260

KPS 70-100

Primary endpoints: Progression Free Survival (PFS) Rate of TE events

Secondary endpoints: PFS by Hyaluronan (HA) level Overall Response Rate (ORR) Overall Survival (OS)

HA

LO-2

02

5

Study evaluating PEGPH20 with ABRAXANE® (nab-paclitaxel) and Gemcitabine in Stage IV metastatic pancreatic ductal adenocarcinoma patients

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Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Results Presented at ASCO 20151

0 2 4 6 8 1 0 1 2 1 40

5 0

1 0 0

S tu d y D u ra tio n (m o n th s )

K-M

Est

ima

te o

f P

rog

ress

ion

Fre

e S

urvi

val (

%)

A G

P A G

PFS in HA-High Patients

At Risk

PAG 23 14 10 6 5 2 1 0 AG 21 14 7 4 0 0 0 0

AG 4.3 months

PAG 9.2 months

HR 0.39 (0.15, 1.04)

p=0.05

Note: 1) Hingorani, et al. ASCO 2015 (Abstract #4006).

ORR and DoR in HA-High Patients (Blinded Central Review)

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u  *1 CR with DoR of 7.4 months

u  ORR in HA-high through clinical hold April 2014: 11/15 (73%) PAG vs. 4/15 (27%) AG, p=0.01

Population

PAG Responders / Total (%);

Duration (months)

AG Responders / Total (%);

Duration (months)

P-value Treated 30 / 74 (41%); 7.4 21 / 61 (34%); 4.2 0.48

Treated w/HA Data 26 / 61 (43%); 8.1 14 / 45 (31%); 4.2 0.22

HA-High* 12 / 23 (52%); 8.1 5 / 21 (24%); 3.7 0.038

HA-Low 14 / 38 (37%); 5.8 9 / 24 (38%); 4.8 0.96



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0 2 4 6 8 1 0 1 2 1 4 1 6 1 80

5 0

1 0 0

S tu d y D u ra tio n (m o n th s )

K-M

Est

imat

e of

Ove

rall

Sur

viva

l (%

)

AG

PAG

At Risk

PAG 23 20 16 14 10 7 4 2 1 0 AG 21 16 16 13 11 6 2 0 0 0

AG 9 months

PAG 12 months HR

0.62 (0.26, 1.46)

u  Data include 12 of 23 PAG patients who discontinued PEGPH20 and received AG alone after clinical hold in April 2014

OS in HA-High 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) 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)

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Study 202: Randomized Phase 2 Study in Pancreatic Cancer Stage 1 Overall Safety Profile Treatment Related AEs >25%1


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Stage 2 Data: TE Events Reduced With Enoxaparin Prophylaxis Enoxaparin Prophylaxis

Dose TE Event Rate

PAG 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 28%

(n=18) 29% (n=7)

Started on 1 mg/kg/day 0% (n=20)

10% (n=10)

Stage 2 (total patients) 13% (n=38)

18% (n=17)

Study 202: Randomized Phase 2 Study in Pancreatic Cancer Interim Safety Results Presented at ASCO 20151


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) could be granted using PFS

as an additional primary endpoint provided it is supported by at least a trend in OS

–  CMA would ultimately be based on the evidence to support benefit:risk

u  Companion Diagnostic (CDx)

–  Transferring our process to Ventana’s platform –  Refining and validating the staining and scoring methodology

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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-fund a global phase 1b/2 clinical trial

u  HALAVEN (eribulin) in the U.S. is indicated for patients with metastatic breast cancer who have received at least two chemotherapeutic regimens for the treatment of metastatic breast cancer2

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New Clinical Collaboration for PEGPH20

NOTE: 1) Source: GLOBOCAN 2012 (http://globocan.iarc.fr/). 2) Source: Halaven (eribulin) Package Insert.

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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 segment –  70% of adoption coming from competitive therapies and

patients naïve to immunoglobulin treatments –  By 2020, PID market to grow to $3BN, with Sub-Q therapies

representing more than 50% of sales –  Expected to start Phase 3 program in CIDP3 in 2015

u  Daratumumab4

–  Start enrolling patients in a phase 1b study of a subcutaneous formulation of daratumumab in multiple myeloma

NOTE: 1) Financial information obtained from Roche investor update (April 22, 2015). Approximate market share percentages presented. 2) Financial information obtained from Baxalta investor update (July 30, 2015). Approximate market share percentages presented. 3) Chronic inflammatory demyelinating polyradiculoneuropathy. 4) Genmab A/S investor update (May 12, 2015).

2nd Quarter 2015 Earnings Call Presentation Financial Review August 10, 2015 Laurie Stelzer Chief Financial Officer

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2Q2015 2Q2014 % Change

Total Revenues $43.4 $18.4 136%

Royalty Revenue $6.4 $1.7 278%

Bulk rHuPH20 Sales $7.7 $6.0 28%

Hylenex® recombinant $4.2 $3.0 40%

Collaboration Revenues $24.7 $7.2 243%

2nd Quarter 2015 Financial Highlights1

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$ U.S. in Millions (unaudited)

NOTE: 1) Dollar amounts and percentages, as presented, are rounded.

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) --

2nd Quarter 2015 Financial Highlights1

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$ U.S. in Millions, except EPS (unaudited)

Cash position 2Q2015: $140.7M Net Cash increase in 2Q2015: $12.2M

NOTE: 1) Dollar amounts and percentages, as presented, are rounded.

New 2015 Financial Guidance

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Previous 2015E Guidance1

New 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.

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PEGPH20 Pancreatic

Cancer

u  Present interim results from Study 202 at ASCO 2015

u  Sign partnership agreement for companion diagnostic

u  Discuss Phase 3 study with the European Medicines Agency

u  Complete Study 202 (Phase 2) enrollment

u  Initiate Study 301 (Phase 3) clinical trial

Completed √

Completed √

Completed √

End of 2015

End of 1Q2016

PEGPH20 Non-Small Cell Lung Cancer

u  Advance through dose-finding portion of Phase 1b study Update in November 2015

PEGPH20 + Immunotherapy in NSCLC and Gastric Cancer

u  Initiate Phase 1b trial using PEGPH20 in combination with KEYTRUDA (pembrolizumab) 2H 2015

PEGPH20 Breast

u  Initiate Phase 1b/2 trial using PEGPH20 in combination with HALAVEN (eribulin) in first line HER2-negative metastatic breast cancer patients with high-HA

Early 2016

ENHANZE Goals

u  Increase number of products entering the clinic

u  Increase number of partnerships

Upcoming Halozyme Goals

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