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, 2020, once filed, and subsequent reports. 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.
Quarterly Net Revenue (in $MM)
61.1
Bottles Sold (SP + SD) by Quarter
5,538
Includes Commercial SP and SD
% of patients starting at reduced dose
37.5%
Reduced dose defined as fewer than 6 pills per day
Region
Partner
Regulatory / Launch Milestones
• March 2019 - Approved in Australia
Australia / SE AsiaIsrael
Canada
Latin America
• December 2019 - Approved in Singapore
• Q2/Q3 2020 - Approved in Brunei, Malaysia, New Zealand
• Q1 2020 - Launched
• Q3 2020 - Approved in metastatic breast cancer
• July 2019 - Approved
• September 2020 - metastatic sNDS accepted by HC
• Q1 2020 - Argentina Launched; mBC approved January 2021
• Q2 2020 - Approved in Chile
• Q3 2020 - Approved in Ecuador
• 2021 - Expected approvals in Brazil, Colombia, Mexico, Peru
• Q4 2019 - Germany, UK, Austria Launched
• Q1 2020 - Sweden Launched
• Q2 2020 - Hong Kong Launched
• Q2 2020 - Approved in China
• Q3 2020 - Approved in Taiwan
• Q4 2020 - Finland / Switzerland Launched
• October 2020 - NDA Filed
Puma Biotechnology
Earnings Call Commercial Update
February 25, 2021
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Puma Biotechnology Inc. published this content on 25 February 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 26 February 2021 09:36:05 UTC.
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.