Puma Biotechnology

June 2024

Forward-LookingSafe-Harbor Statement

This presentation contains forward-looking statements, including statements regarding commercialization of NERLYNX® and the potential indications

and development of our drug candidates. All forward-looking statements involve risks and uncertainties that could cause our actual results to differ

materially from the anticipated results and expectations expressed in these forward-looking statements. These statements are based on our current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, any adverse impact on our business or the global economy and financial markets, generally, from the global COVID-19 pandemic, and the risk factors disclosed in our periodic and current reports filed with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent filings. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. We assume no obligation to update these forward-looking statements except as required by law.

Product Pipeline

Phase I

Phase II

Phase III

Registration

Approval

Neratinib: Tyrosine kinase inhibitor

N

HER2+ Breast Cancer

Extended adjuvant

ExteNET

(Phase III HER2+

EBC*)

Neratinib monotherapy

CONTROL

Metastatic

NALA (Phase

III 3rd Line HER2+

MBC**)

Monotherapy or combo therapy

Metastatic w/ brain mets

TBCRC-022 (T-DM1 + neratinib)

Monotherapy or combo therapy

Alisertib: Aurora kinase A inhibitor

NSABP FB-7

TBCRC-041 (fulvestrant + alisertib)

HRc+*** HER2-negative MBC

Initiation in

Q4'24

ALISCA-Breast1 (alisertib+endocrine)

Metastatic EGFR-mutant NSCLC****

NCT04085315 (alisertib+osimertinib)

Small cell lung cancer

ALISCA-Lung1 (PUMA-ALI-4201)

Initiated in Q1'24

8

*

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* ECB: Early breast cancer

** MBC: Metastatic breast cancer

*** HRc+: Hormone receptor positive ****NSCLC: Non small cell lung cancer

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Puma's Pharmacy and Distributor Network

Hub Services

Specialty Pharmacy Network (SP)

Acaria Health

Accredo

CVS

ONCO 360

Optum /

Patients

Biologics

Diplomat

Sites of Care

Specialty Distributor Network (SD)

Academic Hospitals

McKesson

Community Hospitals

ASD/Oncology Supply

Physician Practices

Cardinal Health

Others (VA, DOD)

DMS Pharmaceutical Group

Inc.

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$40.3 Million Net NERLYNX Revenue in Q1'24

~14% decline in Q1'24 compared to Q1'23

Net Revenue (in $MM)

46.8

40.3

Q1'2023

Q1'2024

Inventory Change ($)

Q1'2023

Q1'2024

-$3.8 mil

-$2.0 mil

~24% decrease Q1'24 compared to Q4'23

Net Revenue (in $MM)

53.2

40.3

Q4'2023

Q1'2024

Inventory Change ($)

Q4'2023

Q1'2024

+$2.1 mil

-$2.0 mil

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2,410 Ex-Factory Bottles Were Sold in Q1'24

~15% decline in Q1'24 compared to Q1'23

Bottles

2,849

2,410

Q1'2023

Q1'2024

Inventory Change Bottles

Q1'2023

Q1'2024

-236

-120

~16% decline in Q1'24 compared to Q4'23

Bottles

2,881

2,410

Q4'2023

Q1'2024

Inventory Change Bottles

Q4'2023

Q1'2024

+127

-120

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~67% of Patients in Q1'24 Started at a Reduced Dose*

% of Patients Starting at Reduced Dose

76.4%

67.9%

69.5% 71.2%

65.4%

66.7%

64.0% 64.0%

59.4% 61.5%

54.9%

42.4%

37.7% 38.7%

28.0% 30.0% 31.0% 32.8%

19.0%

12.0% 11.0%

2.0% 2.0% 3.0% 4.0% 6.0% 7.0%

*Reduced dose defined as fewer than 6 pills per day

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Rest of World Partnerships - Timelines

Region

Partner

Regulatory Approvals

Commercial Launches

• 2019 - Ext. Adj. in Australia, Singapore

Australia / SE Asia

2020

- Ext. Adj. in Brunei, Malaysia, New Zealand

2020 - Singapore

2022

- Ext. Adj. in the Philippines; mBC in Singapore

2021 - Malaysia, Brunei, New Zealand

• 2023 - mBC in Malaysia

Israel

2020

-

Approved in Ext. Adj. and mBC

2020

- Launched

Canada

• 2019 - Ext. Adj. approved

2020

- Launched

2021 - mBC approved

2019

-

Ext Adj in Argentina

2020

-

Ext. Adj in Chile, Ecuador; mBC in Argentina

2020 - Argentina

• 2021 - Ext Adj. and mBC in Peru; mBC in Chile; Ext.

• 2021 - Chile and Peru

Latin America

Adj. in Brazil

2022

- Brazil

• 2022 - Ext. Adj. in Mexico; mBC in Ecuador

• Q1 2023 - Mexico and Colombia

• 2023 - mBC in Colombia and Mexico

Europe

2019

- Germany, UK, Austria

Greater China

2019 - Ext. Adj. EMA and Hong Kong

• 2020 - Sweden, Finland, Scotland, Switzerland, Denmark,

and Hong Kong

Middle East

2020

- Ext. Adj. in China, Taiwan

2021

- China (added to 2021 NRDL), Taiwan, Greece,

North and West Africa

2021

- mBC in Taiwan

Czech Republic, and Luxembourg

South Africa

• 2023 - Ext. Adj. in Morocco, South Africa, and UAE

2022

- Ireland and Spain

• Q1 2024 - Ext. Adj. Syria

Turkey

2023

- Slovakia

Q1 2024 - Morocco

South Korea

2021

- Ext. Adj. in S. Korea

2022

- Launched

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NERLYNX® Extended Adjuvant HER2+ Breast Cancer Market Size

Approximately 28,300 patients (US) with early stage HER2+ breast cancer treated with adjuvant treatment1

Approximately 6,000 patients (US) with HR positive early stage HER2+ breast cancer and no pathological complete response to neoadjuvant treatment (high risk disease)

Approximately 37,000 patients (EU) with early stage HER2+ breast cancer treated with adjuvant treatment1

  • Approximately 65-70% of patients have HR positive disease

1Roche epidemiology slides 09/18

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Puma Financial Guidance for Q2 and FY 2024

Q2 2024

Full Year 2024

NERLYNX revenue guidance:

$38 - 40 million

$183 - 190 million

NERLYNX royalty guidance:

$2.5 - 3 million

$30 - 34 million

NERLYNX license revenue:

$0 million

$1

- 2 million

Net income (loss):

$(6) - (9) million

$12

- 15 million

Gross to net adjustment:

22 - 23%

21.5 - 22.5%

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Disclaimer

Puma Biotechnology Inc. published this content on 03 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 03 June 2024 19:49:04 UTC.