Akebia Therapeutics(AKBA) - 2021 Q2 - Quarterly Report

Financial Performance - Total revenues for the three months ended June 30, 2021, were $52.913 million, a decrease of 41.2% compared to $90.142 million for the same period in 2020[24] - Net loss for the six months ended June 30, 2021, was $(152.618) million, compared to $(236.498) million for the same period in 2020, reflecting a 35.4% reduction[24] - The company reported net losses of $83.0 million for the three months ended June 30, 2021, compared to $175.8 million for the same period in 2020, indicating a reduction in losses by approximately 52.8%[178] - The operating loss for the six months ended June 30, 2021, was $144.3 million, an improvement of $88.7 million (approximately 38.0%) compared to an operating loss of $232.9 million for the same period in 2020[210] Revenue Breakdown - Product revenue, net for the six months ended June 30, 2021, was $63.367 million, up 5.3% from $59.905 million for the same period in 2020[24] - Total net product revenue from U.S. sales of Auryxia was $33.0 million for the three months ended June 30, 2021, compared to $30.7 million for the same period in 2020, representing an increase of 7.5%[44] - For the six months ended June 30, 2021, total net product revenue was $63.4 million, up from $59.9 million in the same period of 2020, reflecting a growth of 5.9%[44] - License, collaboration, and other revenue decreased to $19.95 million in Q2 2021 from $59.45 million in Q2 2020, primarily due to lower payments under collaboration agreements[202] Expenses and Liabilities - Operating loss for the three months ended June 30, 2021, was $(79.341) million, an improvement from $(173.819) million for the same period in 2020[24] - Total liabilities increased to $437.232 million as of June 30, 2021, compared to $396.521 million as of December 31, 2020[22] - Selling, general and administrative expenses increased to $41.651 million for the three months ended June 30, 2021, compared to $35.482 million for the same period in 2020[24] - Research and development expenses for the three months ended June 30, 2021, were $37.214 million, down from $52.819 million for the same period in 2020[24] Cash and Investments - Cash and cash equivalents increased to $246.992 million as of June 30, 2021, from $228.698 million as of December 31, 2020[22] - Total cash, cash equivalents, and restricted cash at the end of the period was $249.0 million, compared to $247.8 million at the end of June 30, 2020[31] - The Company raised approximately $771.4 million in net proceeds from equity sales since inception, including $53.4 million from ATM offerings in the quarter ended June 30, 2021[182] Inventory and Accounts Receivable - Inventory totaled $97.06 million as of June 30, 2021, compared to $86.31 million at the end of 2020, with raw materials at $2.06 million and work in process at $78.29 million[126] - Accounts receivable related to product sales increased to approximately $35.0 million as of June 30, 2021, compared to $21.9 million as of December 31, 2020[46] - The Company recorded a write-down of inventory of $5.4 million for the six months ended June 30, 2021[31] Future Outlook and Development - The Company expects to finance future cash needs through product revenue, public or private equity or debt transactions, and payments from collaborators[35] - The Company will require additional capital to pursue development and commercial activities related to Auryxia and vadadustat[35] - The Company anticipates ongoing decreases in collaboration revenue due to the completion of the global Phase 3 clinical development program for vadadustat[202] - The Company plans to submit a Marketing Authorization Application for vadadustat to the EMA in 2021[176] Regulatory and Collaboration Agreements - The FDA assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2022, for the New Drug Application of vadadustat[34] - The collaboration agreements with Otsuka and MTPC include an aggregate commitment of approximately $573.0 million in cost-share funding, with $272.0 million received at the onset of these agreements[182] - The Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation from the sale of Vafseo in August 2020[34] COVID-19 Impact - The ongoing COVID-19 pandemic has negatively impacted revenue growth, particularly due to higher hospitalization and mortality rates among kidney patients[184] - The company’s revenue growth continues to be negatively impacted by higher hospitalization and mortality rates in the kidney patient populations served due to COVID-19[212]