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Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference June 3 rd , 2015 Joe Turgeon President and Chief Operating Officer

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Page 1: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Spectrum Pharmaceuticals Jefferies 2015 Global Healthcare Conference

June 3rd, 2015

Joe Turgeon President and Chief Operating Officer

Page 2: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Safe Harbor Statement

This presentation contains forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements are based on management’s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, our strategy, the success of our drug candidates, the safety and efficacy of our drug products, product approvals, market potential, product sales, revenue, development, regulatory and approval timelines, product launches, product acquisitions, capital resources and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact.

Risks that could cause actual results to differ include the possibility that our existing and new drug candidates may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of sustained revenue history, our limited experience in establishing strategic alliances, our limited marketing experience, our customer concentration, the possibility for fluctuations in customer orders, evolving market dynamics, our dependence on third parties for clinical trials, manufacturing, distribution, information and quality control and other risks that are described in further detail in the Company's reports filed with the Securities and Exchange Commission. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this presentation except as required by law.

Page 3: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Spectrum’s Focus & Overview

Page 4: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Key Recent Milestones

Page 5: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Strategically Poised for Future Growth

Page 6: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

SPI-2012 Targets Blockbuster Market

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Page 7: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

FcRn

Bone Marrow

Epithelial Layer

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A Novel Molecule for the Treatment of Neutropenia

Potential to compete in a worldwide market that exceeds $6 billion

Page 8: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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SPI-2012 has Shown Strong Phase 2 Data

Multicenter Phase 2 enrolled 156 patients The Phase 2 study met its primary endpoint of

mean duration of severe neutropenia during cycle one

Page 9: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

• Similar ANC trends between 135 µg/kg arm and pegfilgrastim dosing arms • ANC recovery was numerically greater in the 270 µg/kg arm 9

Phase 2: SPI-2012 Median Absolute Neutrophil Count (ANC) Over Time in Cycle 1

0

5

10

15

20

25

30

35

40

0 5 10 15 20

ANC

(109

/L)

Days

SPI-2012 - 270 μg/kg

SPI-2012 - 45 μg/kg

SPI-2012 - 135 μg/kg

pegfilgrastim - 6 mg

Study Drug

Chemo Therapy

Page 10: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Screening Period

30 Days

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SPI-2012 Pivotal Phase 3: ADVANCE Study Schema

Ran

dom

izat

ion

Treatment Period Four 21-day Cycles End of Cycle Visit

Day 1 Day 2

Pegfilgrastim (6 mg, SC)

~250 patients

SPI-2012 (3.6 mg, SC) ~250 patients *Chemotherapy

~500 patients ≥30 Days

After the end of Cycle 4

*TC/TAC depending on North America or International Study

Two 500 Patient trials, one in North America & one International Study

Page 11: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Poziotinib, a Novel pan-HER Inhibitor With Clinical Activity in Several Solid Tumors

Phase 1 Clinical Trials Showed Promising Clinical Activity in: Breast NSCLC Gastric Head and Neck

Page 12: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Molecule Company ORR No. of HER2+

Patients

Prior HER2 directed therapy

Study

Poziotinib Spectrum Pharma/ Hanmi Pharma

60% 10 Trastuzumab Lapatinib Pertuzumab*

Hanmi Aggregate Phase 1

Neratinib Puma Biotechnology

24% 63 Trastuzumab Phase 2: Burstein et al. 2010

Lapatinib (Tykerb®)

GlaxoSmithKline (Approved 2007)

6% 140 Trastuzumab Phase 2: Burstein et al. 2008

Poziotinib

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*One patient treated with prior pertuzumab who had PR

For illustrative purposes only. Comparisons across studies with different trial designs and parameters are not indicative of superiority or inferiority of any compound.

Page 13: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Evomela: Strong Growth Driver Potential Under FDA Review

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Page 14: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Multiple Myeloma Facts

Multiple Myeloma (MM) is considered incurable

Incidence of MM is increasing

~83,000 persons currently with diagnosis1

~25,000 newly diagnosed per year

Stem Cell Transplant is an important therapy for MM patients

Source: 1. ACS Cancer Facts and Figures (2014)

Page 15: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Evomela™ An Alkylating Chemotherapy Agent for use prior to Stem Cell Transplant

One vial system

Propylene Glycol-Free

Potentially longer infusion window

FDA decision expected on October 23, 2015

Evomela is currently under FDA review

Page 16: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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Apaziquone: Potential to be the First Drug Approved for the Treatment of NMIBC

Fifth most common cancer ~74,690 new cases per year1

~500,000 per year living with BC2

High recurrence (60-70%), associated with high risk of mortality3

1ACS Cancer Facts and Figures (2013), 2 SEER Cancer Statistics Review, available http://seer.cancer.gov, 3 ACS 2014. NMIBC

Bladder Cancer (BC)

TURBT is standard of care

No new FDA approved drug in BC in 25 years

NDA Filing planned in 2015

Page 17: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Poziotinib:

A promising Phase 2 pan-HER inhibitor

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Spectrum is Positioned For Long-Term Growth

SPI-2012:

Late-stage drug targeting blockbuster

market

Evomela:

Under FDA review PDUFA date:

October 23, 2015

Apaziquone:

Late-stage drug could satisfy

unmet need in bladder cancer

Page 18: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

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2015 Company Milestones

FDA decision on Evomela October 23, 2015

Initiation of Phase 3 SPI-2012 Trial 2H 2015

File Apaziquone NDA 2H 2015

Start Phase 2 Study for Poziotinib By end of 2015

Milestones Date

Page 19: Spectrum Pharmaceuticals - Jefferies v9... · 2 . Safe Harbor Statement . This presentation contains forward-looking statements regarding future events and the future performance

Thank you

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