Therapy Areas: Respiratory
Puma Biotechnology Posts 1Q23 Results
5 May 2023 - - US-based biopharmaceutical company Puma biotechnology, Inc. (NASDAQ: PBYI) has posted financial results for the first quarter ended March 31, 2023, the company said.

Unless otherwise said, all comparisons are for the first quarter of 2023 compared to the first quarter of 2022.

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma's first commercial product. Product revenue, net in the first quarter of 2023 was USD 46.8m, compared to product revenue, net of USD 40.7m in the first quarter of 2022.

Based on accounting principles generally accepted in the United States, Puma reported net income of USD 1.4 m, or USD 0.03 per basic and diluted share, for the first quarter of 2023, compared to net loss of USD 3.4m, or USD 0.08 per share, for the first quarter of 2022.

Non-GAAP adjusted net income was USD4.2 m, or USD0.09 per basic and diluted share, for the first quarter of 2023, compared to non-GAAP adjusted net loss of USD 0.3m, or USD 0.01 per share, for the first quarter of 2022.

Non-GAAP adjusted net income excludes stock-based compensation expense.

For a reconciliation of GAAP net income to non-GAAP adjusted net income and GAAP net income per share to non-GAAP adjusted net income per share, please see the financial tables at the end of this news release.

Net cash provided by operating activities for the first quarter of 2023 was USD 2.6m, compared to net cash used in operating activities of USD 26.9m in the first quarter of 2022.

At March 31, 2023, Puma had cash, cash equivalents and marketable securities of USD 71.2m, compared to cash, cash equivalents and marketable securities of USD 81.1m at December 31, 2022.

Total revenue consists of product revenue, net from sales of NERLYNX, Puma's first commercial product, license revenue from Puma's sub-licensees and royalty revenue.

For the first quarter ended March 31, 2023, total revenue was USD52.8 m, of which USD46.8 m was net product revenue and USD6.0 m was royalty revenue.

This compares to total revenue of USD45.7 m in the first quarter of 2022, of which USD40.7 m was net product revenue and USD5.0 m was royalty revenue.

Total operating costs and expenses were USD48.4 m for the first quarter of 2023, compared to USD 46.4m for the first quarter of 2022.

Cost of sales was USD13.2 m for the first quarter of 2023, compared to USD10.8 m for the first quarter of 2022.

The USD2.4 m increase resulted primarily from higher royalty expense related to increased net product sales, as well as increased intangible amortization related to the USD12.5 m paid to Pfizer for meeting a commercial sales milestone as of December 31, 2022.

Selling, general and administrative expenses were USD22.5 m for the first quarter of 2023, compared to USD20.4 m for the first quarter of 2022.

The USD2.1 m increase resulted primarily from an increase in payroll and related costs of approximately USD1.6 m, primarily due to salary increases beginning in 2023 as well as higher headcount, and higher travel and meeting expenses.

Research and development expenses were USD12.7 m for the first quarter of 2023, compared to USD15.2 m for the first quarter of 2022.

The USD 2.5m decrease resulted primarily from a decrease in clinical trial expense of approximately USD 3.2m, primarily due to the reduction and closing of SUMMIT clinical trial sites, and was partially offset by an increase in internal R&D of approximately USD 0.8m, primarily due to an increase in payroll-related expenses in 2023.

Total other expenses were USD2.8 m for the first quarter of 2023, compared to total other expenses of USD2.7 m for the first quarter of 2022. The increase resulted primarily from higher interest rates.

Puma biotechnology is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care.

Puma in-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357.

Neratinib, oral was approved by the US Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX (neratinib) tablets.

In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.

NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma biotechnology, Inc.

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A.

Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer.

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance.
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