On March 1, 2022 – Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, reported financial results for the fourth quarter and full-year ended December 31, 2021 and recent business updates related to pre-commercialization activities ahead of a potential first-in-class U.S. launch for vadadustat, Akebia’s investigational oral therapeutic for the treatment of anemia due to chronic kidney disease (CKD) (Press release, Akebia, MAR 1, 2022, View Source [SID1234609307]). Vadadustat is currently under review by the U.S. Food and Drug Administration (FDA) with a scheduled Prescription Drug User Fee Act (PDUFA) date of March 29, 2022.

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"The PDUFA date for vadadustat is fast approaching. We recognize how transformational the potential approval would be for Akebia and, true to our purpose as a company, our team continues to work tirelessly to deliver a new oral therapeutic option for the patients we serve," said John P. Butler, Chief Executive Officer of Akebia. "We are prepared for what we believe will be a significant catalyst for the company marked by launching a potential first-in-class oral therapeutic for people living with anemia due to CKD, subject to regulatory approval."

Last month Akebia and Vifor Pharma Group (Vifor Pharma) amended and restated the terms of their license agreement, which provides important access to up to 60% of U.S. dialysis patients through existing Vifor Pharma relationships, supporting a successful commercial launch of vadadustat, if approved. Vifor Pharma completed a $20 million equity investment in Akebia, and will pay Akebia a $25 million upfront payment and contribute an initial $40 million in refundable working capital to partially fund launch supply. The companies also defined profit share economics of potential vadadustat revenue.

"Many of our on-going pre-commercialization activities, including amending the terms of our relationship with Vifor Pharma, are aimed at ensuring patient access for vadadustat," said Dell Faulkingham, Chief Commercial Officer of Akebia. "If approved, we will immediately initiate the process to secure reimbursement for vadadustat under the Transitional Drug Add-on Payment Adjustment (TDAPA) period for dialysis organizations, which we expect will take approximately six months. We believe TDAPA designation for vadadustat will be an important driver for adoption within U.S. dialysis organizations, if approved."

Akebia continues to optimize its sales, marketing, and payor strategies to support Auryxia (ferric citrate). Akebia ended 2021 with notable Auryxia net product revenue growth and the strongest quarter of net product revenue to date while the phosphate binder market declined by 8.1% year-over-year in the U.S., due in part to the impact of COVID-19 on kidney disease patients. Akebia achieved $142.2 million in net product revenue in 2021 due to improved commercial contracts and payor mix.

"Both the 2021 and our expected 2022 Auryxia revenue growth is due to our team’s commitment to patients and healthcare providers, even against the backdrop of the COVID-19 pandemic," added Dell Faulkingham. "Our renal focused field team has proven its ability to successfully engage with the kidney community and thoughtfully outline our value proposition. This expertise establishes a strong foundation from which to launch vadadustat, if approved."

Fourth Quarter and Full-Year 2021 Financial Results

Revenues: Total revenue was $59.6 million for the fourth quarter of 2021 compared to $56.7 million for the fourth quarter of 2020, and $213.6 million for the full-year 2021 compared to $295.3 million for the full-year 2020.

Collaboration revenue was $17.5 million for the fourth quarter of 2021 compared to $22.1 million for the fourth quarter of 2020, and $71.4 million for the full-year 2021 compared with $166.4 million for the full-year 2020. The decrease in both periods compared to the same periods in 2020 was primarily due to lower collaboration revenue from Otsuka Pharmaceuticals Co. Ltd (Otsuka) driven by lower development costs incurred subject to cost share provisions under both the Otsuka collaboration agreement for the U.S. and the Otsuka collaboration agreement for certain territories outside the U.S. as Akebia successfully completed the INNO2VATE and PRO2TECT global Phase 3 clinical programs in 2020 and is currently engaged in close-out activities with respect to the programs.
Net product revenue was $42.1 million for the fourth quarter of 2021 compared with $34.6 million for the fourth quarter of 2020, an increase of approximately 22 percent. Net product revenue was $142.2 million for the full-year 2021 compared to $128.9 million for the full-year 2020, an increase of approximately 10 percent.
COGS: Cost of goods sold was $50.4 million for the fourth quarter of 2021 compared to $63.2 million for the fourth quarter of 2020. Cost of goods sold was $153.4 million for the full-year 2021, compared with $295.9 million for the full-year 2020. Cost of goods sold includes a non-cash charge related to excess purchase commitments of $18.0 million and $33.4 million, for the fourth quarter and full year 2021, respectively.

R&D Expenses: Research and development expenses were $29.6 million for the fourth quarter of 2021 compared to $37.6 million for the fourth quarter of 2020, and $147.9 million for the full-year 2021 compared to $218.5 million for the full-year 2020. Fourth quarter 2021 expenses included a one-time credit of $8.6 million representing a reimbursement from Vifor Pharma following the sale of the Priority Review Voucher (PRV), which proceeds were subsequently paid to Otsuka as reimbursement for their contribution to purchase the PRV.

SG&A Expenses: Selling, general and administrative expenses were $44.8 million for the fourth quarter of 2021 compared to $40.3 million for the fourth quarter of 2020, and $174.2 million for the full-year 2021 compared to $153.9 million for the full-year 2020. The increase for the full year 2021 was primarily due to higher marketing expenses, increased headcount-related costs, and one-time legal costs.

Net Loss: Net loss was $70.7 million for the fourth quarter of 2021 compared to $87.0 million for the fourth quarter of 2020, and $282.8 million for the full-year 2021 compared to $383.5 million for the full-year 2020. The decrease in net loss for the full-year 2021 compared to the prior year was due primarily to higher product revenues, lower cost of goods sold and lower operating expenses, partially offset by lower collaboration revenue.

Cash Position: Cash and cash equivalents as of December 31, 2021 were $149.8 million. Akebia believes that its cash resources will be sufficient to fund its current operating plan through at least the next twelve months. Akebia’s base operating plan assumes a timely regulatory approval of vadadustat for the treatment of anemia due to CKD in dialysis dependent patients, as well as milestones and product revenues as an important source of funding of our cash runway.