On May 6, 2021 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2021 (Press release, Puma Biotechnology, MAY 6, 2021, View Source [SID1234579362]). Unless otherwise stated, all comparisons are for the first quarter of 2021 compared to the first quarter of 2020.

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Product revenue, net consists entirely of sales revenue from NERLYNX, Puma’s first commercial product. Net NERLYNX revenue in the first quarter of 2021 was $45.8 million, compared to $48.6 million in the first quarter of 2020.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021, compared to a net loss of $16.9 million, or $0.43 per share, for the first quarter of 2020.

Non-GAAP adjusted net income was $22.4 million, or $0.56 per basic share and $0.55 per diluted share for the first quarter of 2021, compared to non-GAAP adjusted net loss of $8.0 million, or $0.20 per share, for the first quarter of 2020. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) 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 2021 was $15.7 million, compared to net cash used in operating activities of $11.5 million in the first quarter of 2020. At March 31, 2021, Puma had cash, cash equivalents and marketable securities of $109.1 million, compared to cash, cash equivalents and marketable securities of $93.4 million at December 31, 2020.

"During the first quarter, we continued to face the challenges brought about by the COVID-19 pandemic and the reduction in commercial access caused by it," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We are hopeful that with the progress made with vaccinations, commercial access will improve in 2021 which will greatly aid our commercial abilities. We continue to remain focused on and committed to providing support to patients battling cancer."

"In terms of clinical development, we are pleased that during the first quarter we were able to achieve the completion of enrollment in the randomized cohorts of the Phase II SUMMIT trial of neratinib for patients with hormone receptor-positive breast cancer that has a HER2 mutation. Enrollment in the other cohorts in SUMMIT continued as well, including for patients with EGFR exon 18 mutated non-small cell lung cancer and HER2 mutated cervical cancer. Additionally, our global partners continued to launch NERLYNX in several new countries during the first quarter and we look forward to launches in additional countries throughout 2021."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting top line data from the randomized cohort of the Phase II SUMMIT trial of neratinib in hormone receptor positive breast cancer that has a HER2 mutation (2021); (ii) reporting Phase II data from the SUMMIT trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2-2021); (iii) conducting a pre-NDA meeting with the FDA to discuss accelerated approval of neratinib in HER2-mutated

hormone receptor positive breast cancer and HER2-mutated cervical cancer (2021); (iv) reporting data from the Phase II TBCRC-022 trial of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2-2021); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2021); and (vi) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries (2021)."

Revenue

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, 2021, total revenue was $98.2 million, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue. The $50.0 million of license revenue in the first quarter of 2021 represents an upfront payment for providing our existing partner Pierre Fabre with development, manufacturing, and commercial rights to NERLYNX in Greater China. Total revenue was $51.2 million in the first quarter of 2020, of which $48.6 million was net product revenue, $2.0 million was license revenue, and $0.6 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $78.0 million for the first quarter of 2021, compared to $65.5 million for the first quarter of 2020.

Cost of Sales

Cost of sales was $29.6 million for the first quarter of 2021, of which $20.0 million represents a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China. Cost of sales was $9.1 million for the first quarter of 2020.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $28.2 million for the first quarter of 2021, compared to $30.9 million for the first quarter of 2020. The $2.7 million decrease resulted primarily from decreases in stock-based compensation expense of approximately $1.1 million, travel and meetings of approximately $1.4 million and other expenses of approximately $0.4 million, partially offset by an increase in professional fees of approximately $0.3 million.

Research and Development Expenses

Research and development expenses were $20.2 million for the first quarter of 2021, compared to $25.5 million for the first quarter of 2020. The $5.3 million decrease resulted primarily from decreases in clinical trial costs of approximately $2.7 million, stock-based compensation expense of approximately $2.0 million and consultant and contractor costs of approximately $0.6 million.

Total Other Expenses

Total other expenses were $3.7 million for the first quarter of 2021, compared to $2.6 million for the first quarter of 2020. The $1.1 million increase resulted primarily from decreases in interest income and other income of approximately $0.5 million, as well as an increase in interest expense of $0.5 million.

Conference Call

Puma Biotechnology will host a conference call to discuss its first quarter 2021 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 6, 2021. The call may be accessed by dialing 1-877-709-8150 (domestic) or 1-201-689-8354 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available shortly after completion of the call and will be archived on Puma’s website for 90 days.