On March 18, 2019 Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease, reported preliminary financial results for the full year ended December 31, 2018 and business highlights (Press release, Akebia, MAR 18, 2019, View Source [SID1234534452]).
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"2018 was a transformational year for Akebia," said John P. Butler, President and Chief Executive Officer of Akebia Therapeutics. "We successfully executed a number of strategic initiatives to advance our mission, and with the recent completion of our merger with Keryx, we have emerged as a leading, fully-integrated renal company with the potential to greatly improve care for patients with kidney disease. We are pleased with the robust growth we have seen with Auryxia (ferric citrate) during 2018. Looking ahead, we see the potential for substantial revenue growth in both the hyperphosphatemia and iron deficiency anemia markets."
Mr. Butler continued, "With respect to vadadustat, our lead product candidate, we believe that it has the potential to set a new standard of care for patients with anemia due to chronic kidney disease with a differentiated clinical profile. We recently announced positive top-line results from two pivotal phase 3 studies in Japan conducted by our collaboration partner, Mitsubishi Tanabe Pharma Corporation, which adds to the body of data supporting vadadustat’s potential to serve as a much-needed therapeutic option for patients with anemia due to chronic kidney disease. In addition, we continue to drive our global phase 3 program for vadadustat, with enrollment completed in the larger of the two INNO2VATE studies and enrollment expected to complete in the smaller INNO2VATE study by April 2019. The next 18 months will be a very busy time, with significant catalysts ahead of us."
Business Highlights
Auryxia
Pro forma unaudited Auryxia sales in 2018 were $96 million, representing 72% growth over 2017.
Total Auryxia prescriptions for 2018 were approximately 163,000, representing 85% growth over 2017.
Exit market share for Auryxia tablets in 2018 was 6.6% compared to 4.2% in 2017, exceeding the share gain of all other phosphate binders (branded and generic) in the same period.
Vadadustat Japanese Phase 3 Program
Announced positive top-line results from two phase 3, active-controlled, pivotal studies evaluating vadadustat in Japanese subjects with anemia due to chronic kidney disease (CKD).
Data from these two pivotal studies as well as from two additional single-arm studies in peritoneal dialysis and hemodialysis subjects, also recently announced, is expected to serve as the basis for a Japanese New Drug Application (JNDA) submission by Mitsubishi Tanabe Pharma Corporation (MTPC), expected in 2019.
Vadadustat Global Phase 3 Program
Enrollment in the larger of the two INNO2VATE studies (the "Conversion Study") was completed in February 2019, with a total of 3,554 subjects enrolled. Enrollment in the smaller INNO2VATE study (the "Correction Study"), enrolling approximately 350 subjects, is expected to be completed by April 2019. The company expects to report top-line data from both INNO2VATE studies in the second quarter of 2020, subject to the accrual of major adverse cardiac events (MACE).
The company expects enrollment in the PRO2TECT studies to complete in 2019, with up to approximately 3,700 subjects expected to be enrolled. Top-line results are anticipated in mid-2020, subject to the accrual of MACE.
The two INNO2VATE studies evaluating dialysis-dependent CKD subjects and the two PRO2TECT studies evaluating non-dialysis dependent CKD subjects are global, phase 3, active-controlled, open-label, non-inferiority, cardiovascular outcome studies of vadadustat for the treatment of anemia due to CKD.
Preliminary Financial Results (unaudited)
As a result of the completion of the company’s business combination with Keryx Biopharmaceuticals, Inc. (Keryx) on December 12, 2018 and the time required to complete the allocation of the merger consideration to the fair value of the acquired assets and liabilities as well as the assessment of the associated tax impacts, the company is announcing preliminary results for the full year 2018, which are based on currently available information and are subject to revision, as further discussed below. The company anticipates a delayed filing of its Annual Report on Form 10-K for the fiscal year ended December 31, 2018 (Annual Report) and plans to file a Form 12b-25, Notification of Late Filing, with the Securities and Exchange Commission, which will provide the company with a 15 calendar-day extension.
Net product revenues for Auryxia from December 12, 2018, the date of our merger with Keryx, through December 31, 2018 were $6.8 million. The company did not have any product revenue prior to our merger with Keryx.
Collaboration revenues for the fourth quarter of 2018 were $53.0 million, compared with $90.6 million during the same period in 2017. The decrease was primarily due to $42.9 million of deferred revenue associated with the MTPC collaboration agreement being recognized as revenue during the fourth quarter of 2017, as the criteria for revenue recognition were satisfied in that quarter. No revenue was recognized under the MTPC collaboration agreement in the fourth quarter of 2018.
Collaboration revenues for the full year 2018 were $200.9 million compared to $181.2 million for the full year 2017. The increase was due to increased revenues recognized under the collaboration agreements with Otsuka Pharmaceutical Co. Ltd. (Otsuka). Through 2018, Otsuka has funded 52.5% of the company’s phase 3 development costs for vadadustat, and in the second quarter of 2019, Otsuka is expected to increase its contribution to 80%.
Cost of goods sold was $6.3 million for the period from December 12, 2018 through December 31, 2018, consisting primarily of costs associated with the manufacture of Auryxia and $4.8 million for the fair-value inventory step-up as a result of the merger accounting.
Research and development expenses were $87.1 million for the fourth quarter of 2018 compared to $68.4 million for the fourth quarter of 2017, and $291.1 million for the full year 2018 compared to $230.9 million for the full year 2017. The increase for both periods is primarily attributable to an increase in external costs related to the continued advancement of the PRO2TECT and INNO2VATE phase 3 program, as well as increased headcount and consulting costs required to support our expanding research and development programs.
Selling, general and administrative expenses were $55.1 million for the fourth quarter of 2018 compared to $7.6 million for the fourth quarter of 2017, and $87.1 million for the full year 2018 compared to $27.0 million for the full year 2017. The increase in selling, general and administrative expenses is primarily attributable to merger-related costs of $49.5 million, of which $41.7 million was incurred in the fourth quarter of 2018, including a non-cash expense of $13.4 million related to the issuance of shares to Baupost Group Securities, L.L.C. in connection with its conversion of Keryx convertible notes. The increase for both periods was also attributable to an increase in costs to support our research and development programs, including headcount, information technology and compensation-related costs.
Akebia reported a pre-tax net loss for the fourth quarter of 2018 of $88.4 million, as compared to a pre-tax net income of $15.5 million for the fourth quarter of 2017. The pre-tax net loss for the fourth quarter of 2018 includes total merger-related costs of $46.5 million. The pre-tax net income reported for the fourth quarter of 2017 was attributable to $42.9 million of collaboration revenue recognized in connection with the MTPC collaboration agreement, as the criteria for revenue recognition was satisfied in the fourth quarter.
For the full year 2018, the Company reported a pre-tax net loss of $171.9 million, as compared to a pre-tax net loss for the full year 2017 of $73.7 million. The pre-tax net loss for the full year 2018 includes total merger-related costs of $54.3 million.
Akebia ended 2018 with cash, cash equivalents and available-for-sale securities of $321.6 million. The company expects its cash resources, including the prepaid quarterly committed cost-share funding from its collaboration partners, to fund its current operating plan into the third quarter of 2020.
Conference Call and Webcast
Akebia management will host its full-year 2018 and business highlights conference call and webcast beginning at 4:30 p.m. Eastern Time today, March 18, 2019.
The conference call can be accessed by dialing (877) 458-0977 within the United States and Canada and (484) 653-6724 for all other locations. The confirmation code is 1376157. Participants should dial in 10 minutes prior to the scheduled start time.
A live webcast of the conference call will be available in the "Investors" section of the company’s website at www.akebia.com.
Beginning the morning of March 19, 2019, the call will be available for replay via telephone and the archived webcast will be available on Akebia’s website. To listen to the telephone replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 1376157. The telephone replay will be available for six days following the call.