Total revenue reported by the company in the quarter consisted primarily of product revenue from net sales of NERLYNX, Puma's first commercial product, license revenue and royalty revenue. For Q2/19, total revenue was $53.9 million, of which $53.8 million was net NERLYNX revenue and $0.1 million was royalty revenue received from Puma's sub-licensees, compared to $50.8 million in Q2/18, all of which was net product revenue. For H1/19, total revenue was $153.0 million of which $99.4 million was net product revenue and $53.5 million of license revenue received from Puma's sub-licensees, and $0.1 million was royalty revenue. This compares to total revenue for H1/18 of $117.3 million, of which $86.8 million was net product revenue and $30.5 million was license revenue.
Cost of sales was $9.3 million for Q2/19 and $17.3 million for H1/19, compared to $8.8 million for Q2/18 and $15.2 for H1/18.
Research and development (R&D) expenses were $36.9 million for Q2/19 compared to $43.3 million for Q2/18 and were $72.6 million in H1/19, compared to $90.2 million for H1/18. The company noted that the $17.6 million year-to-date decrease resulted primarily from decreases of approximately $13.8 million for stock-based compensation, $3.5 million for internal R&D primarily related to payroll and payroll-related expenses, and $0.5 million in consulting fees related to clinical trials.
Overall, Total operating costs and expenses decreased to $79.7 million Q2/19, compared to $92.2 million in Q2/18 and were $168.9 million in H1/19 compared to $182.1 in H1/18.
The company reported a lower U.S. (GAAP) net loss of $37.4 million, or $0.97 per share for Q2/19 compared to a net loss of $44.3 million, or $1.17 per share in Q2/18, as well as a lower net loss for H1/19 of $47.5 million, or $1.23 per share, compared to a net loss of $68.7 million, or $1.82 per share for H1/18.
Net cash provided by operating activities for Q2/19 was $44.2 million, compared to $17.6 million in Q2/18 and as of June 30, 2019, the company had cash, cash equivalents, and marketable securities of $117.7 million.
Alan H. Auerbach, chairman, CEO and president of Puma stated, "The second quarter of 2019 included the achievement of several key milestones for Puma...this included sequential NERLYNX sales growth and the expansion of our global presence with NERLYNX with our European licensing agreement with Pierre Fabre. We saw the achievement of additional key milestones in July with the filing of the new drug application for neratinib in the metastatic breast cancer indication and obtaining approval for NERLYNX in the extended adjuvant indication from Health Canada....We anticipate the following key milestones during the remainder of 2019: (i) meeting with the FDA to discuss the clinical development and regulatory strategy for the SUMMIT trial in the third quarter of 2019; (ii) reporting additional data from the Phase II CONTROL trial in the fourth quarter of 2019; and (iii) receiving regulatory decisions for the extended adjuvant HER2-positive early stage breast cancer indication in additional countries."
The company, which is headquartered in Los Angeles, Calif., is a biopharmaceutical company that focuses on the development and commercialization of innovative products to enhance cancer care. Puma Biotech in-licenses the global development and commercialization rights to three drug candidates: PB272 (neratinib, oral) PB272 (neratinib, intravenous); and PB357. Neratinib, oral was approved by the FDA in July 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 U.S. as NERLYNX (neratinib) tablets. NERLYNX, a registered trademark of Puma Biotechnology, was granted marketing authorization by the European Commission in September 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.
On the news this morning, Puma shares opened more than 20% higher at $11.13 (+$1.92, +20.85%) over the prior day's closing price of $9.21. The company shares, which started the day with a short interest position of approximately 13.50%, have traded today between $10.75 and $12.15, and closed at $11.16 (+$1.95, +21.17%).[NLINSERT]
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