Akebia Therapeutics Reviews First Quarter 2023 Monetary Outcomes and Latest Enterprise Highlights

Akebia to host convention name on Could 8 at 8:30 a.m. ET

• Introduced vadadustat is now accepted in 32 nations following European Fee advertising and marketing authorization

• Expects a response to Formal Dispute Decision from FDA inside subsequent 30 days

• Launched optimistic top-line outcomes from vadadustat different dosing research

• Reviews Auryxia^® (ferric citrate) web product income of $34.8M for Q1 2023

• Affirms 2023 Auryxia web product income steering at $175–$180M

CAMBRIDGE, Mass., Could 8, 2023 /PRNewswire/ — Akebia Therapeutics^®, Inc. (Nasdaq: AKBA), a biopharmaceutical firm with the aim to raised the lives of individuals impacted by kidney illness, as we speak reported monetary outcomes for the primary quarter ended March 31, 2023 and supplied enterprise highlights.

“Approval of Vafseo™ (vadadustat) by the European Fee is a big milestone for us and for dialysis sufferers in Europe with anemia on account of power kidney illness,” stated John P. Butler, Chief Govt Officer of Akebia. “This is a vital step as we proceed to ship on our dedication to raised the lives of individuals with kidney illness. Now we’re working to finish a partnership to launch Vafseo in Europe, and we’re wanting to conclude our attraction course of with the FDA.”

In April, the European Fee granted advertising and marketing authorization for Vafseo (vadadustat), for the remedy of symptomatic anemia related to power kidney illness (CKD) in adults on power upkeep dialysis. Akebia plans to pick out a accomplice to commercialize Vafseo in Europe. Vadadustat is now accepted in 32 nations. Akebia additionally expects a regulatory opinion on vadadustat within the United Kingdom, Switzerland and Australia over the course of this yr.

Within the U.S., Akebia has continued to interact with the Workplace of New Medicine on its Formal Dispute Decision concerning vadadustat. Dr. Stein, the deciding authority on the attraction, indicated he has accomplished his inside discussions, and the corporate expects a response inside the subsequent 30 days.

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Akebia additionally not too long ago reported optimistic top-line outcomes from FO₂CUS, a research evaluating the efficacy and security of vadadustat in hemodialysis sufferers who have been transformed from a long-acting erythropoiesis-stimulating agent (ESA) to 3 instances weekly oral vadadustat dosing for the upkeep remedy of anemia. The info demonstrated that vadadustat met the first and secondary efficacy endpoints and was non-inferior to an ESA within the remedy of anemia on account of power kidney illness in sufferers on hemodialysis when used 3 times every week on the time of dialysis and with a comparable security profile to the present commonplace of care.

“Our group has been diligent in efforts to handle spend and maintain a discount in working prices,” stated David A. Spellman, Chief Monetary Officer of Akebia. “Auryxia income was impacted by a $5 million discount within the quantity of channel stock from yr finish. We consider quarterly fluctuations in our income will proceed, which don’t influence income steering of $175–$180 million. Our group is delivering working expense financial savings, with an nearly 50% discount versus the primary quarter of 2022, and nearly 30% discount from the fourth quarter of 2022. We proceed to execute strategic selections to allow us to function with money readily available and Auryxia income for at the least the subsequent twelve months.”

Monetary Outcomes

• Revenues: Whole income was $40.1 million within the first quarter of 2023 in comparison with $61.7 million for the primary quarter of 2022.

• COGS: Value of products offered was $19.5 million for the primary quarter of 2023 in comparison with $31.3 million for the primary quarter of 2022. The lower was primarily on account of decrease extra and obsolescence reserves related to Auryxia, decrease manufacturing prices related to the availability of Vafseo to Mitsubishi Tanabe Pharma Company for business sale in Japan, and decrease freight prices because of a decrease quantity of shipments. The corporate continues to hold a non-cash intangible amortization cost of $9.0 million per quarter by the fourth quarter of 2024.

• R&D Bills: Analysis and growth bills have been $19.7 million for the primary quarter of 2023 in comparison with $43.8 million for the primary quarter of 2022. The lower was primarily on account of decreased headcount associated prices because of the April 2022 discount in pressure, decreased outsourced contract providers, decreased scientific trial prices, and growth bills associated to vadadustat.

• SG&A Bills: Promoting, common and administrative bills have been $25.2 million for the primary quarter of 2023 in comparison with $44.3 million for the primary quarter of 2022. The lower was primarily on account of decreased headcount associated prices because of the 2022 reductions in pressure and decrease advertising and marketing bills following receipt of the whole response letter for vadadustat from the U.S. Meals and Drug Administration (FDA).

• Internet Loss: Internet loss was $26.2 million for the primary quarter of 2023 in comparison with $62.4 million for the primary quarter of 2022. The lower in web loss was due primarily to decrease price of products offered and decrease working bills, partially offset by decrease revenues.

• Money Place: Money and money equivalents as of March 31, 2023 have been roughly $57.0 million. Akebia believes that its money assets shall be ample to fund its present working plan for at the least the subsequent twelve months. Akebia’s goal is to fund its present working plan with current money assets and money from operations for at the least the subsequent twelve months. Future selections by the FDA or different regulatory companies associated to the potential regulatory approval of vadadustat, or Akebia’s capacity to generate extra worth from vadadustat by partnerships or different transactions might doubtlessly additional prolong our money runway, however should not presently mirrored within the working plan. Akebia additionally plans to proceed to work on initiatives to increase its revenues from Auryxia past anticipated lack of exclusivity in March 2025.

Convention Name

Akebia will host a convention name on Monday, Could 8 at 8:30 a.m. ET to debate its monetary outcomes and up to date enterprise highlights. To entry the decision, please register by clicking on this Registration Hyperlink, after which you’ll be supplied with dial in particulars. To keep away from delays, we encourage dialing into the convention name fifteen minutes forward of the scheduled begin time.

A stay webcast of the convention name shall be out there by way of the Traders part of Akebia’s web site at: http://ir.akebia.com. An internet archive of the webcast might be accessed by way of the Traders part of Akebia’s web site at http://ir.akebia.com roughly two hours after the occasion.

About Akebia Therapeutics

Akebia Therapeutics, Inc. is a completely built-in biopharmaceutical firm with the aim to raised the lives of individuals impacted by kidney illness. Akebia was based in 2007 and is headquartered in Cambridge, Massachusetts. For extra data, please go to our web site at www.akebia.com, which doesn’t type part of this launch.

About Vadadustat

Vadadustat is an oral hypoxia-inducible issue prolyl hydroxylase inhibitor designed to imitate the physiologic impact of altitude on oxygen availability. At greater altitudes, the physique responds to decrease oxygen availability with stabilization of hypoxia-inducible issue, which might result in elevated purple blood cell manufacturing and improved oxygen supply to tissues. Vadadustat is an investigational new drug and isn’t accepted by the U.S. Meals and Drug Administration (FDA). On March 29, 2022, the FDA issued an entire response letter to Akebia’s New Drug Utility for vadadustat for the remedy of anemia on account of power kidney illness (CKD). Vadadustat is accepted in Europe for the remedy of symptomatic anemia on account of CKD in grownup sufferers on power upkeep dialysis. In Japan, vadadustat is accepted as a remedy for anemia on account of CKD in each dialysis-dependent and non-dialysis dependent grownup sufferers.

IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat)

For security data, view the European Abstract of Product Traits (SPC/SmPC) for Vafseo™ (vadadustat) at https://ec.europa.eu/well being/paperwork/community-register/2023/20230424158854/anx_158854_en.pdf.

IMPORTANT U.S. SAFETY INFORMATION FOR AURYXIA (ferric citrate) CONTRAINDICATION

AURYXIA (ferric citrate) is contraindicated in sufferers with iron overload syndromes, e.g., hemochromatosis.

WARNINGS AND PRECAUTIONS

• Iron Overload: Will increase in serum ferritin and transferrin saturation (TSAT) have been noticed in scientific trials with AURYXIA in sufferers with power kidney illness (CKD) on dialysis handled for hyperphosphatemia, which can result in extreme elevations in iron shops. Assess iron parameters previous to initiating AURYXIA and monitor whereas on remedy. Sufferers receiving concomitant intravenous (IV) iron might require a discount in dose or discontinuation of IV iron remedy.

• Threat of Overdosage in Kids As a result of Unintended Ingestion: Unintended ingestion and ensuing overdose of iron-containing merchandise is a number one reason behind deadly poisoning in youngsters below 6 years of age. Advise sufferers of the dangers to youngsters and to maintain AURYXIA out of the attain of kids.

ADVERSE REACTIONS

Commonest antagonistic reactions with AURYXIA have been:

• Hyperphosphatemia in CKD on Dialysis: Diarrhea (21%), discolored feces (19%), nausea (11%), constipation (8%), vomiting (7%) and cough (6%).

• Iron Deficiency Anemia in CKD Not on Dialysis: Discolored feces (22%), diarrhea (21%), constipation (18%), nausea (10%), belly ache (5%) and hyperkalemia (5%).

SPECIFIC POPULATIONS

• Being pregnant and Lactation: There are not any out there knowledge on AURYXIA use in pregnant girls to tell a drug-associated threat of main delivery defects and miscarriage. Nonetheless, an overdose of iron in pregnant girls might carry a threat for spontaneous abortion, gestational diabetes and fetal malformation. Information from rat research have proven the switch of iron into milk, therefore, there’s a risk of toddler publicity when AURYXIA is run to a nursing lady.

To report suspected antagonistic reactions, contact Akebia Therapeutics at 1-844-445-3799.

Please see full Prescribing Info

Ahead-Trying Statements

Statements on this press launch concerning Akebia Therapeutics, Inc.’s (“Akebia’s”) technique, plans, prospects, expectations, beliefs, intentions and targets are forward-looking statements inside the that means of the U.S. Personal Securities Litigation Reform Act of 1995, as amended, and embrace, however should not restricted to, statements concerning: Akebia’s plans, methods and prospects for its enterprise, together with with respect to the Formal Dispute Decision Request that Akebia submitted with the FDA to attraction the whole response letter that it acquired in March 2022; Akebia’s expectations on the timing for sure regulatory selections for vadadustat by the FDA and regulatory authorities within the United Kingdom, Switzerland and Australia; Akebia’s plans with respect to commercializing and finishing a partnership for vadadustat in Europe; Akebia’s future plans with respect to its strategic development and working plans; Akebia’s income steering for Auryxia in 2023 and assumptions associated thereto; Akebia’s plans with respect to vadadustat as a remedy of anemia on account of CKD in sufferers on dialysis; and Akebia’s targets, targets and expectations with respect to its working plan, bills, money assets and sources of funding for its money runway, together with its perception that its current money assets and revenues from Auryxia shall be ample to fund its present working plan for at the least the subsequent twelve months. The phrases “intend,” “consider,” “plan,” “aim,” “count on,” “potential,” “will,” “proceed,” derivatives of those phrases, and comparable references are meant to determine forward-looking statements, though not all forward-looking statements comprise these figuring out phrases. Precise outcomes, efficiency or expertise might differ materially from these expressed or implied by any forward-looking assertion because of varied dangers, uncertainties and different components, together with, however not restricted to, dangers related to: the potential demand and market potential and acceptance of, in addition to protection and reimbursement associated to, Auryxia, together with estimates concerning the potential market alternative; the aggressive panorama for Auryxia, together with potential generic entrants; the power of Akebia to draw and retain certified personnel; Akebia’s capacity to implement price avoidance measures and scale back working bills; selections made by well being authorities, such because the FDA, with respect to regulatory filings, together with the New Drug Utility and the Formal Dispute Decision Request for vadadustat; Akebia’s capacity to accomplice for vadadustat in Europe in a well timed method, on acceptable phrases, or in any respect; the potential therapeutic advantages, security profile, and effectiveness of vadadustat; the outcomes of preclinical and scientific analysis; the direct or oblique influence of the COVID-19 pandemic on regulators and Akebia’s enterprise, operations, and the markets and communities through which Akebia and its companions, collaborators, distributors and clients function; manufacturing, provide chain and high quality issues and any remembers, write-downs, impairments or different associated penalties or potential penalties; and early termination of any of Akebia’s collaborations. Different dangers and uncertainties embrace these recognized below the heading “Threat Components” in Akebia’s Annual Report on Kind 10-Ok for the yr ended December 31, 2022, and different filings that Akebia might make with the U.S. Securities and Change Fee sooner or later. These forward-looking statements (besides as in any other case famous) converse solely as of the date of this press launch, and, besides as required by legislation, Akebia doesn’t undertake, and particularly disclaims, any obligation to replace any forward-looking statements contained on this press launch.

Akebia Therapeutics^®, Auryxia^® (ferric citrate), and Vafseo™ (vadadustat) are registered logos of Akebia Therapeutics, Inc. and its associates.

Akebia Therapeutics Contact
Mercedes Carrasco
[email protected]

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SOURCE Akebia Therapeutics