Business
Ardelyx Reports Second Quarter 2021 Financial Results
FREMONT, Calif. and WALTHAM, Mass., Aug. 13, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery,
About this update from Ardelyx, Inc.
[{"type":"text","content":"FREMONT, Calif. and WALTHAM, Mass., Aug. 13, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business events and financial results for the second quarter ended June 30, 2021. \n\n \n \n \n \n \n \n\n \nRecent Business Events\nOn July 29, 2021, the company announced that the U.S. Food & Drug Administration (FDA) issued a Complete Response Letter (CRL) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The company plans to request a Type A meeting with the FDA to discuss the CRL and potential next steps to support approval of the company's NDA. On August 2, 2021, the company began implementing a restructuring plan to better align the company's workforce and anticipated commercial and development spend with the company's capital resources and the needs of its business following the receipt of the CRL. In connection with the restructuring, the company estimates that it will incur aggregate restructuring charges of approximately $3.4 million, which will be recorded primarily in the third quarter 2021, related to one-time termination notice and severance payments and other employee-related costs. The company expects that the workforce reduction will decrease its annual cash compensation costs by approximately $17 million. Separately, two presentations further highlighting promising tenapanor data were given at the European Renal Association – European Dialysis and Transplant Association (ERA-EDTA) Virtual Congress 2021. Second Quarter 2021 Financial Results\nCash Position: As of June 30, 2021, Ardelyx had total cash, cash equivalents and short-term investments of $171.8 million, as compared to total cash, cash equivalents and investments of $188.6 million as of December 31, 2020. Revenue: The company generated $1.3 million in revenue for the three months ended June 30, 2021, which primarily represents collaborative development revenue from the 2019 Research Collaboration and Option Agreement between the company and Kyowa Kirin Co., Ltd. R&D Expenses: Research and development expenses were $26.0 million for the three...