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 | ||||||||
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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.
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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.