RedHill Biopharma (NASDAQ: RDHL) reported Q3 EPS of $0.03, $0.41 better than the analyst estimate of ($0.38). Revenue for the quarter came in at $1.4 million versus the consensus estimate of $1.77 million.

Financial highlights for the quarter ended September 30, 2019:

• Net Revenues of $1.4 million in the third quarter of 2019, compared to $1.6 million in the second quarter of 2019.
• Gross Profit of $0.8 million in the third quarter of 2019, compared to $1.1 million in the second quarter of 2019.
• Research and Development Expenses of $2.8 million in the third quarter of 2019, compared to $7.0 million in the second quarter of 2019. The decrease is attributable primarily to completion of the Phase 3 study with Talicia® and the one-time PDUFA fee of $2.6 million for the Talicia® New Drug Application (NDA) in the second quarter of 2019.
• Selling, Marketing and Business Development Expenses of $4.9 million in the third quarter of 2019, compared to $4.1 million in the second quarter of 2019. The increase is attributable primarily to the Company’s launch preparations for Talicia®.
• General and Administrative Expenses of $2.9 million in the third quarter of 2019, compared to $2.4 million in the second quarter of 2019. The increase is attributable primarily to an increase in professional services expenses to support launch preparations for Talicia®.
• Operating Loss of $9.8 million in the third quarter of 2019, compared to $12.4 million in the second quarter of 2019. The decrease is attributable primarily to the lower R&D expenses.
• Net Cash Used in Operating Activities of $8.9 million in the third quarter of 2019, compared to $10.4 million in the second quarter of 2019. The decrease is attributable primarily to the one-time PDUFA fee of $2.6 million for the Talicia® NDA submission paid in the second quarter of 2019.
• Liquidity and Capital ResourcesCash Balance2 as of September 30, 2019, was $25.6 million, compared to $34.9 million as of June 30, 2019. Cash balance as of October 22, 2019 was approximately $59 million, following the $36.3 million strategic investment in RedHill by Cosmo Pharmaceuticals.In July 2019, pursuant to the previously filed shelf registration statement, the Company filed a prospectus supplement for the issuance and sale of up to $60.0 million of the Company’s American Depositary Shares (“ADSs”) in an “at the market” (“ATM”) offering led by SVB Leerink LLC. As of September 30, 2019, no ADS’s have been offered, issued or sold under the ATM offering.

Key Highlights:

• U.S. FDA approval of Talicia® for the treatment of Helicobacter pylori infection in adults
• Strategic partnership with Cosmo Pharmaceuticals, including investment of $36.3 million and exclusive rights to commercialize Aemcolo® in the U.S. for travelers’ diarrhea
• Accelerating expansion of commercial sales team in the U.S. ahead of planned launches of Aemcolo® and Talicia® in Q4/2019 and Q1/2020, respectively
• Debt-free balance sheet with approximately $59 million as of October 22, 2019 following the investment by Cosmo Pharmaceuticals
• Hosting an investor and analyst event in New York on November 22, 2019, to discuss planned U.S. commercial launches of Talicia® and Aemcolo®
• Management to host a conference call today at 8:30 a.m. EST to review the third quarter financial results and operational highlights

“The past month has been transformational for RedHill with the U.S. FDA approval of Talicia® and the strategic collaboration with Cosmo Pharmaceuticals, which included an investment of $36 million in RedHill and the in-licensing of an additional GI product, Aemcolo®,” said Micha Ben Chorin, RedHill’s Chief Financial Officer. “We are currently expanding our sales force and finalizing preparations for the planned U.S. commercial launches of Aemcolo® in the fourth quarter of 2019 and Talicia® in the first quarter of 2020.”

For earnings history and earnings-related data on RedHill Biopharma (RDHL) click here.