On August 10, 2020 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease, reported financial results for the second quarter ended June 30, 2020. As previously announced, in lieu of a financial results and business update call, Akebia management plans to host a conference call and webcast in early September to report top-line data from PRO2TECT, the second of its two global Phase 3 cardiovascular outcomes programs (Press release, Akebia, AUG 10, 2020, View Source [SID1234563326]). The two PRO2TECT studies evaluated the efficacy and safety of vadadustat, the Company’s investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"We had an incredible quarter in terms of advancing our vadadustat clinical development program, bringing us that much closer to achieving our purpose to better the life of each person impacted by kidney disease. We reported exciting, positive top-line data from our global Phase 3 INNO2VATE program highlighting vadadustat’s potential as a new oral standard of care for treating anemia due to CKD in adult patients on dialysis, and topped off the quarter with the first regulatory approval of vadadustat in Japan," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "The next chapter of Akebia’s growth story is starting to unfold and as previously announced, we plan to share top-line data from PRO2TECT in early September."
Recent Business Highlights
In August, the Company announced database lock for PRO2TECT and plans to report top-line data from PRO2TECT in early September. This announcement follows Akebia’s earlier update provided in May that it had achieved the target number of major adverse cardiovascular events (MACE) for the PRO2TECT studies.
In July, the Company announced an investigator-sponsored research study by The University of Texas Health Science Center at Houston (UTHealth) in Houston, Texas, evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19 infection.
In June, Mitsubishi Tanabe Pharma Corporation (MTPC), Akebia’s collaboration partner in Japan for vadadustat, obtained the first regulatory approval of vadadustat (Japan trade name: VAFSEO), as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients, by the Ministry of Health, Labour and Welfare in Japan.
In May, the Company reported positive top-line data from INNO2VATE, the first of its two global Phase 3 cardiovascular outcomes programs, which evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis. Vadadustat showed consistency across both efficacy and all MACE components, achieving the primary efficacy and safety endpoints, as well as the key secondary efficacy endpoint, of the studies. Please refer to Akebia’s INNO2VATE Data Announcement for the top-line data.
In May, the Company completed a public offering of its common stock raising net proceeds of $142.4 million.
In May, the Company announced that its collaboration partner, Japan Tobacco, Inc., filed a supplemental New Drug Application with the Pharmaceuticals and Medical Devices Agency (PMDA) seeking an additional indication for Riona (generic name in Japan: ferric citrate hydrate) to treat adult patients with iron deficiency anemia (IDA) in Japan.
Second Quarter Financial Results
Revenues: Total revenue was $90.1 million for the second quarter of 2020 compared to $100.8 million for the second quarter of 2019. The decline versus the prior year period was driven by lower collaboration revenue consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.
Collaboration revenue was $59.4 million for the second quarter of 2020 compared to $71.7 million in the second quarter of 2019.
Net product revenue for Auryxia (ferric citrate) was $30.7 million for the second quarter of 2020 compared with $29.1 million in the second quarter of 2019, an increase of 5.5 percent.
COGS: Cost of goods sold increased $136.9 million compared to the prior year period primarily due to a non-cash impairment charge of $115.5 million related to Auryxia, and higher non-cash inventory write-downs, which included $12.4 million largely related to a manufacturing quality issue related to Auryxia identified in the second quarter of 2020.
R&D Expenses: Research and development expenses were $52.8 million for the second quarter of 2020 compared to $85.7 million for the second quarter of 2019. The decline versus the prior year period was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE studies and nearing completion of the PRO2TECT studies.
SG&A Expenses: Selling, general and administrative expenses were $35.5 million for the second quarter of 2020 compared to $36.1 million for the second quarter of 2019.
Net Loss: Net loss was $175.8 million for the second quarter of 2020 compared to $58.2 million for the second quarter of 2019. The increase in net loss compared to the prior year period was due primarily to the non-cash impairment charge and higher non-cash inventory write-downs.
Cash Position: Cash, cash equivalents and available-for-sale securities as of June 30, 2020 were $295.3 million. The increase in the Company’s cash position is primarily attributable to net proceeds of $142.4 million from Akebia’s public offering of common stock, which was completed in May 2020. The Company believes that its cash runway extends beyond the expected U.S. launch of vadadustat.
"The non-cash impairment charge reflects the change in value of the Auryxia intangible asset on our balance sheet, primarily driven by the compounding impact of the 2018 decision by the Centers for Medicare and Medicaid Services (CMS) rescinding Medicare Part D coverage of Auryxia for its IDA indication and imposing a prior authorization requirement for the hyperphosphatemia indication," stated David A. Spellman, Chief Financial Officer of Akebia Therapeutics. "While we are frustrated and disappointed that a resolution has not been reached on this matter for the benefit of patients, we remain optimistic about Auryxia’s growth prospects."