Pharma stock under pressure: Aurinia Pharmaceuticals Inc (NASDAQ: AUPH)

Aurinia Pharmaceuticals Inc (NASDAQ: AUPH) stock fell over 0.4% on 15^th May, 2020 (As of 12:17 pm GMT-4; Source: Google finance) after the company posted mixed results for the first quarter of FY 20. The Company has reported a consolidated net loss of $16.5 million for the first quarter ended March 31, 2020, as compared to a consolidated net loss of $12.4 million for the first quarter ended March 31, 2019.  The company has incurred increased R&D expenses of $13.8 million for the first quarter ended March 31, 2020 compared to $10.6 million for the first quarter ended March 31, 2019. The increase in these expenses were mainly due to higher costs related to the preparation of the NDA submission and related supporting activities, the ongoing VOS Phase 2/3 AUDREY trial, the AURORA 2 extension trial and the expansion of the medical affairs team to support the launch of voclosporin. At the end of March, 2020, Aurinia had cash, cash equivalents and short-term investments of $286.1 million compared to $306 million as at December 31, 2019. The company had generated net cash used in operating activities of $22.7 million for the first quarter ended March 31, 2020 compared to $13.1 million for the first quarter ended March 31, 2019. The Company believes that it has sufficient financial resources to fund its current plans, that include conducting its ongoing research and development programs, completing the NDA submission to the FDA, conducting pre-commercial and launch activities, manufacturing and packaging commercial drug supply required for launch, and fund its supporting corporate and working capital needs through 2021.

AUPH in the first quarter of FY 20 has reported the adjusted loss per share of 15 cents, beating the analysts’ estimates for the adjusted loss per share of 20 cents, according to the Zacks Consensus Estimate. The company had reported the adjusted revenue of $0.03 million in the first quarter of FY 20, missing the analysts’ estimates for revenue by 50%.

On the other hand, Aurinia held a positive and successful Pre-NDA meeting with the FDA during the quarter 2020. The Company presented information about the safety and efficacy data to be included in the filing, had reviewed the format and content of the planned application, and gained agreement on the rolling review plans for filing modules of the NDA. The company is on track to file the complete NDA to the FDA by the end of the second quarter of 2020.