Akebia Therapeutics

Akebia Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of therapeutics for patients with kidney diseases. The firm is also involved in the development and commercialization of drugs for the treatment of renal and metabolic disorders. Its products include Auryxia and Vadadustat. The company was founded by Joseph H. Gardner, John M. Rice, Michael E. Pape, Josh P. Fairbank, and Robert A. Shalwitz on February 27, 2007 and is headquartered in Cambridge, MA.

Earnings data Q1 2021

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Earnings data Q1 2022

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Earnings data Q1 2023

Earnings data Q2 2023

Earnings data Q3 2023

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Earnings data Q1 2024

Earnings data Q2 2024

Earnings data Q3 2024

Earnings data Q4 2024

Akebia Therapeutics posts robust Q4 results, eyes expansion opportunities

Akebia Therapeutics showcased a strong performance in Q4 2022, highlighting revenue growth, regulatory progress, and strategic initiatives. The company faces challenges in regulatory processes and funding but is well-positioned to capitalize on opportunities for growth and innovation.

Akebia Therapeutics excels in Q1 2023, faces regulatory challenges

Akebia Therapeutics demonstrated strong performance in Q1 2023 with key achievements in product approvals and clinical study results, while also addressing revenue challenges and cost management.
The company faces challenges related to regulatory compliance and revenue decline but has opportunities to explore new therapeutic applications and strategic partnerships for growth.
Overall, Akebia's proactive approach to addressing challenges and pursuing opportunities positions it well for future success in the competitive biopharmaceutical market.

Akebia Therapeutics advances vadadustat globally, eyes U.S. launch in 2024

Akebia Therapeutics showcased operational progress and financial stability during the Q2 earnings call, emphasizing vadadustat's global potential.
While facing regulatory challenges and competitive pressures, the company's strategic partnerships and leadership confidence signal growth opportunities.
Analysts' inquiries highlighted areas for improvement, suggesting a need for clearer communication and strategic clarity in key operational areas.
Overall, Akebia remains focused on advancing vadadustat towards potential U.S. approval, positioning for future growth and market success.

Akebia Therapeutics reports strong Q3 earnings and readies for vadadustat launch

Akebia Therapeutics is poised for the potential launch of vadadustat with strong financial performance and a well-prepared commercial infrastructure.
The company faces challenges in pricing strategies and market competition but has opportunities to capture a significant share of the anemia treatment market.
Overall, Akebia Therapeutics remains focused on delivering value to patients and shareholders through vadadustat's potential success in the U.S. market.

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Akebia Therapeutics, Inc. (NASDAQ:AKBA ) Q2 2023 Earnings Conference Call August 25, 2023 9:00 AM ET Company Participants Mercedes Carrasco - Senior Director of Corporate Communications and Investor Relations John Butler - President and Chief Executive Officer Ellen Snow - Senior Vice President, Chief Financial Officer, Treasurer Steven Burke - Senior Vice President, Research & Development and Chief Medical Officer Conference Call Participants Allison Bratzel - Piper Sandler Ed Arce - H.C. Wainwright Julian Harrison - BTIG Operator Good day and welcome to Akebia's Second Quarter 2023 Financial Results Call.

Akebia Therapeutics, Inc. (AKBA) Q2 2023 Earnings Call Transcript

Akebia to host conference call on August 25, 2023 at 9:00 a.m. ET Expects to resubmit NDA for vadadustat as a treatment for anemia due to CKD in adult patients on dialysis in Q3 2023 Reports Auryxia® (ferric citrate) net product revenue of $42.2 million for Q2 2023 and reaffirms 2023 net product revenue guidance of $175.0-$180.0 million CAMBRIDGE, Mass.

Akebia Therapeutics Reports Second Quarter 2023 Financial Results and Recent Business Highlights

Akebia Received Type A Meeting Minutes from the FDA CAMBRIDGE, Mass. , Aug. 24, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that the company expects to resubmit its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease in adult patients on dialysis by the end of the third quarter of 2023.

Akebia Therapeutics Expects to Resubmit Vadadustat NDA in Third Quarter 2023

Akebia to Host Conference Call on August 25 th at 9:00 a.m. ET CAMBRIDGE, Mass.

Akebia Therapeutics to Report Second Quarter Financial Results and Discuss Recent Business Highlights

Akebia Receives Notification of Deficiency from Nasdaq Regarding Late Form 10-Q Filing CAMBRIDGE, Mass. , Aug. 17, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced plans to release its financial results for the second quarter ended June 30, 2023 by Friday, August 25, 2023 prior to the open of the financial markets.

Akebia Therapeutics to Report Second Quarter Financial Results by August 25, 2023

Akebia announces late filing of its second quarter earnings and Form 10-Q Akebia reaffirms 2023 net product revenue guidance of $175 - $180 million Akebia believes its cash resources as of June 30, 2023 will be sufficient to fund its current operating plan through at least the next twelve months Akebia expects to resubmit NDA for vadadustat as a treatment for anemia due to CKD in adult patients on dialysis in Q3 2023 CAMBRIDGE, Mass. , Aug. 10, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it has filed with the U.S. Securities and Exchange Commission (SEC) a Form 12b-25 Notification of Late Filing with regard to its Quarterly Report on Form 10Q for the quarter ended June 30, 2023.

Akebia Therapeutics Provides Update on Form 10-Q Filing

CAMBRIDGE, Mass. , July 19, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will participate in a fireside chat at the H.C.

Akebia Therapeutics to Present at the H.C. Wainwright Kidney Conference

CAMBRIDGE, Mass. , July 18, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that Akebia completed an End of Dispute Type A meeting with the U.S. Food and Drug Administration (FDA) to discuss Akebia's forthcoming resubmission of its New Drug Application (NDA) for vadadustat as a treatment for anemia due to chronic kidney disease (CKD) in adult patients on dialysis.

Akebia Therapeutics Completed Type A Meeting with the FDA and Expects to Resubmit Vadadustat NDA in Third Quarter 2023

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CAMBRIDGE, Mass. , June 29, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced topline results from IMPACT, a Phase 4 collaborative study investigating the impact of Auryxia® (ferric citrate), when used as the primary phosphate-lowering therapy, on the utilization of erythropoiesis-stimulating agent (ESA) and intravenous (IV) iron as well as on laboratory parameters indicative of phosphate and anemia management compared to the standard of care (SOC) in adult patients with chronic kidney disease (CKD) on dialysis.

Akebia Therapeutics Announces Positive Top-Line Results of Phase 4 IMPACT Study of Auryxia® (ferric citrate) for In-Center and Home Dialysis Patients

CAMBRIDGE, Mass. , June 20, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA) today announced that the Swiss Agency for Therapeutic Products (Swissmedic) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Akebia Announces Swissmedic Approval of Vafseo® (vadadustat)

Here is how Akebia Therapeutics (AKBA) and Haemonetics (HAE) have performed compared to their sector so far this year.

Is Akebia Therapeutics (AKBA) Stock Outpacing Its Medical Peers This Year?

CAMBRIDGE, Mass. , June 13, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that Ellen Snow is joining Akebia as its new Senior Vice President, Chief Financial Officer and Treasurer, beginning on July 17, 2023.

Akebia Therapeutics Announces New Chief Financial Officer

Akebia Therapeutics (AKBA) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

All You Need to Know About Akebia Therapeutics (AKBA) Rating Upgrade to Buy

Here is how Akebia Therapeutics (AKBA) and Brookdale Senior Living (BKD) have performed compared to their sector so far this year.

Are Medical Stocks Lagging Akebia Therapeutics (AKBA) This Year?

CAMBRIDGE, Mass. , June 2, 2023 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that John Butler, Chief Executive Officer, will present at the Jefferies Healthcare Conference on Wednesday, June 7, 2023 at 8:30 a.m.

Akebia Therapeutics to Present at Jefferies Healthcare Conference

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FDA denies formal dispute resolution, but outlines path to resubmit NDA for dialysis-dependent patients without new clinical studies Akebia plans to request Type A meeting and then resubmit NDA Akebia will host a conference call on Tuesday, May 30 at 8:30 a.m. ET CAMBRIDGE, Mass.

FDA Provides Akebia Therapeutics a Path Forward for Vadadustat

Akebia Therapeutics Inc. is rated a Strong Buy due to its overly discounted revenue and strong prospects in the large Chronic Kidney Disease market. The company's valuation should be at least $716 million, more than 3x its current valuation, considering just Auryxia's revenue and the Healthcare Price/Revenue sector ratio. Risks include more total liabilities than total assets, cash flow negativity, stiff competition in the CKD drug market, and the possibility of FDA not approving vadadustat.

Akebia Therapeutics: Buy This Undervalued Stock At Just 77% Of Revenue

Medice brings extensive expertise in nephrology and an established European dialysis business Akebia to receive a $10 million upfront payment, potential for up to $100 million in commercial milestone payments, and tiered royalties up to 30% of net sales in dialysis Akebia retains majority of economics in non-dialysis indication if approved by EMA and retains rights to all other indications  CAMBRIDGE, Mass. , May 25, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced an agreement with MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice – The Health Family), for Medice to market Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor developed by Akebia to treat anemia due to chronic kidney disease (CKD), in Europe.

Akebia Therapeutics Enters into License Agreement with Medice Arzneimittel Pütter GmbH&Co.KG for the Commercialization of Vafseo® for the Treatment of Anemia associated with CKD in Europe and Australia

Akebia gained approval for Vafseo, its anemia therapy for chronic kidney disease patients, in Great Britain. The company is awaiting word on its appeal to the FDA to get approval for the therapy in the U.S. In May, Akebia said it has $57 million, enough cash to fund operations for another 12 months.

Why Shares of Akebia Therapeutics Were Up Tuesday

CAMBRIDGE, Mass. , May 22, 2023 /PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today announced that it has received a formal notice from The Nasdaq Stock Market (Nasdaq) stating that Akebia has regained compliance with the $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5550(a)(2), and that Akebia is in compliance with all applicable listing standards.

Akebia Therapeutics Regains Compliance with Nasdaq Minimum Bid Price Requirement

CAMBRIDGE, Mass. , May 22, 2023 /PRNewswire/ -- Akebia Therapeutics ® , Inc. (Nasdaq: AKBA) today announced that the United Kingdom (UK) Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for Vafseo® (vadadustat), an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of symptomatic anemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.

Akebia Announces UK MHRA Approval of Vafseo® (vadadustat) for the Treatment of Symptomatic Anemia Associated with Chronic Kidney Disease in Adults on Chronic Maintenance Dialysis

Akebia Therapeutics, Inc. (NASDAQ:AKBA ) Q1 2023 Earnings Conference Call May 8, 2023 8:30 AM ET Company Participants Mercedes Carrasco - Senior Director of Investor and Corporate Communications John Butler - Chief Executive Officer Dave Spellman - Chief Financial Officer Conference Call Participants Allison Bratzel - Piper Sandler Thomas Yip - H.C. Wainwright Operator Good day, and thank you for standing by.

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