Puma Biotechnology, Inc.

Equities

PBYI

US74587V1070

Biotechnology & Medical Research

Market Closed - Nasdaq Other stock markets 04:00:00 2024-04-26 pm EDT			5-day change	1st Jan Change
5.02 ^USD	+2.87%		+0.20%	+15.94%

Mar. 20	Puma Biotechnology Plans to Start Breast Cancer Combination Study in Second Half; Shares Rise	MT
Mar. 20	Puma Biotechnology, Inc. Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer	CI

Puma Biotechnology : Corporate Presentation

March 06, 2024 at 03:15 pm EST

Puma Biotechnology

March 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		NCT02038647 (paclitaxel + alisertib)
	8				Initiated in Q1'24

			ALISCA-Lung1	(PUMA-ALI-4201)
									*


	Copyright 2024 Puma Biotechnology	* ECB: Early breast cancer	** MBC: Metastatic breast cancer	* HRc+: Hormone receptor positive **NSCLC: Non small cell lung cancer	3

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.

$53.2 Million Net NERLYNX Revenue in Q4'23

~1% decline compared to Q4'22

Net Revenue (in $MM)

53.7	53.2
Q4'2022	Q4'2023

Inventory Change ($)

Q4'22	Q4'23
+$2.6 mil	+$2.1 mil

~3% increase Q4'23 compared to Q3'23

Net Revenue (in $MM)

51.6	53.2
Q3'2023	Q4'2023

Inventory Change ($)

Q3'23	Q4'23

+$0.6 mil	+$2.1 mil

2,881 Ex-Factory Bottles Were Sold in Q4'23

~13% decline compared to Q4'22

	Bottles
3,323
	2,881
Q4'2022	Q4'2023

Inventory Change Bottles

Q4'22	Q4'23

+164	+127

~0.2% growth compared to Q3'23

	Bottles
2,874	2,881
Q3'2023	Q4'2023

Inventory Change Bottles

Q3'23	Q4'23
+32	+127

~76% of Patients in Q4'23 Started at a Reduced Dose*

% of Patients Starting at Reduced Dose

76.4%

	67.9%	69.5% 71.2%
65.4%	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

Rest of World Partnerships - Timelines

Region	Partner		Regulatory Approvals		Commercial Launches

	• 2019 - Ext. Adj. in Australia, Singapore
	•	2020 - Ext. Adj. in Brunei, Malaysia, New Zealand	•	2020 - Singapore
Australia / SE Asia	•	Q2 2022 - Ext. Adj. in the Philippines	•	Q2 2021 - Malaysia
	•	Q3 2022 - mBC in Singapore	•	Q3 / Q4 2021 - Brunei, New Zealand
	• Q3 2023 - mBC in Malaysia
Israel	•	2020 -	Approved in Ext. Adj. and mBC	•	2020 - Launched
Canada	• 2019 - Ext. Adj. approved	•	2020 - Launched
• Q2 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.
	• Q2 2021 - Chile
		Adj. in Brazil
		• Q4 2021 - Peru
Latin America	•	Q1 2022 - Ext. Adj. in Mexico
• Q3 2022 - Brazil
	• Q3 2022 - mBC in Ecuador
	• Q1 2023 - Mexico
	• Q1 2023 - mBC in Colombia
	• Q3 2023 - mBC in Colombia
	• Q3 2023 - mBC in Mexico

Europe				• 2019 - Germany, UK, Austria
•	2019 - EMA approval	•	2020 - Sweden, Finland, Scotland, Switzerland, Denmark
Greater China
•	2019 - Ext. Adj. in Hong Kong	•	2020 - Hong Kong
Middle East	•	2020 - Ext. Adj. in China, Taiwan	•	Q1 2021 - China (added to 2021 NRDL), Taiwan
North and West Africa	•	Q4 2021 - mBC in Taiwan	•	Q1 2021 - Greece, Czech Republic
South Africa	•	Q1 2023 - Ext Adj. in Morocco, South Africa	•	Q1 2022 - Ireland
Turkey	•	Q3 2023 - ext adj in UAE	•	Q3 2022 - Spain
•	Q1 2024 - ext adj Syria	•	Q2 2023 - Slovakia

				•	Q1 2024 - Morocco
South Korea	•	Q4 2021 - Ext. Adj. in S. Korea	•	Q1 2022 - Launched

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

Puma Financial Guidance for Q1 and FY 2024

	Q1 2024	Full Year 2024
NERLYNX revenue guidance:	$38 - $40 million	$183 to $190 million

NERLYNX royalty guidance:

$2.5 - $3 million

$30 - $34 million

Net income guidance:

$(10) - $(12) million

$12 - $15 million

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Disclaimer

Puma Biotechnology Inc. published this content on 04 March 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 06 March 2024 20:15:09 UTC.

Latest news about Puma Biotechnology, Inc.

Puma Biotechnology Plans to Start Breast Cancer Combination Study in Second Half; Shares Rise	Mar. 20	MT
Puma Biotechnology, Inc. Announces FDA Allowance to Proceed Under IND for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer	Mar. 20	CI
Puma Biotechnology, Inc. Reports Earnings Results for the Full Year Ended December 31, 2023	Feb. 29	CI
Transcript : Puma Biotechnology, Inc., Q4 2023 Earnings Call, Feb 29, 2024	Feb. 29
Puma Biotechnology, Inc. Provides Earnings Guidance for the First Quarter and Full Year of 2024	Feb. 29	CI
Earnings Flash (PBYI) PUMA BIOTECHNOLOGY Posts Q4 EPS $0.31, vs. Street Est of $0.37	Feb. 29	MT
Puma Biotechnology, Inc. Reports Earnings Results for the Fourth Quarter Ended December 31, 2023	Feb. 29	CI
Puma Biotechnology, Inc. Announces Initiation of ALISCA-Lung1 Phase II Trial of Alisertib in Small Cell Lung Cancer	Feb. 13	CI
Puma Biotechnology, Inc. Announces Phase II Clinical Trial Design for Alisertib in HER2-Negative, Hormone Receptor-Positive Metastatic Breast Cancer	Dec. 11	CI
Transcript : Puma Biotechnology, Inc., Q3 2023 Earnings Call, Nov 02, 2023	Nov. 02
Earnings Flash (PBYI) PUMA BIOTECHNOLOGY Posts Q3 EPS $0.17, vs. Street Est of $0.14	Nov. 02	MT
Puma Biotechnology, Inc. Provides Earnings Guidance for the Fourth Quarter and Full Year of 2023	Nov. 02	CI
Puma Biotechnology, Inc. Reports Earnings Results for the Third Quarter and Nine Months Ended September 30, 2023	Nov. 02	CI
Puma Biotechnology, Inc. Announces Presentation of Findings from a Phase I/II Study of Alisertib and Pembrolizumab for Rb-Deficient Head and Neck Squamous Cell Carcinomas at the 2023 AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics Meeting	23-10-14	CI
North American Morning Briefing : Stock Futures Edge Higher as PMI Data Awaited	23-09-22	DJ
Puma Biotechnology Gets FDA Orphan Drug Designation For Alisertib	23-09-21	MT
Puma Biotechnology Stock Up 6.9% on New FDA Orphan Drug Designation	23-09-21	DJ
Puma Biotechnology Gets Orphan Designation for Small Cell Lung Cancer Drug	23-09-21	DJ
FDA Clears Puma Biotechnology to Begin Mid-Stage Trial in Small Cell Lung Cancer	23-08-08	MT
Puma Biotechnology, Inc. Announces FDA Clearance of IND for Alisertib in Small Cell Lung Cancer	23-08-08	CI
Puma Biotechnology, Inc. Reports Earnings Results for the Second Quarter and Six Months Ended June 30, 2023	23-08-03	CI
Transcript : Puma Biotechnology, Inc., Q2 2023 Earnings Call, Aug 03, 2023	23-08-03
Earnings Flash (PBYI) PUMA BIOTECHNOLOGY Posts Q2 EPS $0.10, vs. Street Est of $0.07	23-08-03	MT
Puma Biotechnology, Inc. Provides Earnings Guidance for the Third Quarter and Full Year 2023	23-08-03	CI
Puma Biotechnology, Inc. Announces Presentation of Biomarker Findings from a Phase II Study of Alisertib with Paclitaxel Versus Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer at the 2023 ASCO Annual Meeting	23-06-04	CI

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Company Profile

Puma Biotechnology, Inc. is a biopharmaceutical company. The Company is focused on the development and commercialization of products to enhance cancer care. The Company's lead product is NERLYNX, an oral version of neratinib, for the treatment of HER2-positive breast cancer. Neratinib is a potent irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4 It also engaged in the development and commercialization of, alisertib. Alisertib is a selective, small molecule inhibitor of aurora kinase A that is designed to disrupt mitosis leading to apoptosis of rapidly proliferating tumor cells that are dependent on aurora kinase A. Its neratinib has clinical application in the treatment of several other cancers as well, including other tumor types that over-express or have a mutation in HER2 or epidermal growth factor receptor (EGFR), such as breast cancer, cervical cancer, lung cancer, or other solid tumors.

Sector

Biotechnology & Medical Research

Calendar

2024-05-02 - Q1 2024 Earnings Release

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Ratings for Puma Biotechnology, Inc.

Trading Rating

Investor Rating

ESG Refinitiv

C+

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Mean consensus

HOLD

Number of Analysts

Last Close Price

5.02 USD

Average target price

4.333 USD

Spread / Average Target

-13.68%

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