Akebia Therapeutics Reports Second Quarter 2024 Financial Results and Recent Business Highlights
Rhea-AI Summary
Akebia Therapeutics reported its Q2 2024 financial results, revealing a net loss of $8.6M, an improvement from $11.2M in the same quarter last year. Total revenues dropped to $43.6M from $56.4M, mainly due to a decrease in license, collaboration, and other revenues. Net product revenues stood at $41.2M, a slight decline from $42.2M in Q2 2023. Research & Development expenses significantly decreased to $7.6M from $20.2M due to the completion of certain clinical trials. The company set the WAC for its recently FDA-approved Vafseo® at $1,278 for a 30-day supply, with sales expected to begin in January 2025. Akebia expects its existing cash resources and operations to fund its activities for at least two years.
Positive
- Net loss improved to $8.6M from $11.2M in Q2 2023.
- Research & Development expenses decreased to $7.6M from $20.2M.
- Akebia expects its cash resources to fund operations for at least two years.
Negative
- Total revenues dropped to $43.6M from $56.4M.
- Net product revenues decreased to $41.2M from $42.2M.
News Market Reaction
On the day this news was published, AKBA gained 7.21%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
- Vafseo® (vadadustat) Tablets market availability on track for January 2025
- TDAPA application submission and WAC pricing announcement for Vafseo complete
- Second quarter 2024 Auryxia® (ferric citrate) net product revenues of
$41.2 million
Akebia to host conference call at 8:00 a.m. ET on August 8
"Since receiving FDA approval in late March, our key priority has been to execute on our launch strategy developed with a goal for Vafseo to become the standard of care in the treatment of anemia for dialysis patients," said John P. Butler, Chief Executive Officer of Akebia. "Our team is actively engaged with prescribers, and I'm extremely encouraged by the positive reception we've seen across the kidney community for a new choice in anemia management. Equally important, our commercial team is now in active discussions with dialysis organizations covering the vast majority of patients to contract both Auryxia® (ferric citrate) and Vafseo, giving our team a unique opportunity to contract across the portfolio."
Vafseo Global Launch Activities
- In June, Akebia submitted its Transitional Drug Add-on Payment Adjustment (TDAPA) application. Akebia expects to have Healthcare Common Procedure Coding System (HCPCS) codes assigned in October 2024 and TDAPA designation by January 1, 2025.
- Akebia set the Vafseo wholesale acquisition cost (WAC) at
$1,278 $15,500 - Akebia partner MEDICE Arzneimittel Pütter GmbH&Co.KG (Medice) launched Vafseo in
Germany andAustria in June and inthe Netherlands in August. - In July, Akebia regained full rights to sell Vafseo in the
U.S. and is now able to contract directly with all dialysis organizations following the execution of a royalty-based termination agreement with CSL Vifor to simplify operational execution and improve economics.
Corporate Updates
In June, Erik Ostrowski joined Akebia as Senior Vice President, Chief Financial Officer and Chief Business Officer. Mr. Ostrowski brings over 20 years of finance and biotech operating experience, with a background in investment banking, including as a director of healthcare investment banking at Leerink Partners. He brings an impressive track record of corporate development leadership and strategic transaction execution.
Akebia reported second quarter 2024 Auryxia net product revenues of
Financial Results
- Revenues: Total revenues were
$43.6 million $56.4 million $10 million - Net product revenues were
$41.2 million $42.2 million - License, collaboration and other revenues were
$2.4 million $14.1 million
- Net product revenues were
- Cost of Goods Sold: Cost of goods sold (COGS) was
$17.0 million $17.3 million $9.0 million - Research & Development Expenses: Research and development expenses were
$7.6 million $20.2 million - Selling, General & Administrative Expenses: Selling, general and administrative expenses were
$26.9 million $27.0 million - Net Loss: Net loss was
$8.6 million $11.2 million - Cash Position: Cash and cash equivalents as of June 30, 2024 were
$39.5 million U.S. Vafseo launch, for at least two years.
Conference Call
Akebia will host a conference call on Thursday, August 8 at 8:00 a.m. Eastern Time to discuss second quarter 2024 earnings. To access the call, please dial (800) 715-9871 (
A live webcast of the conference call will be available via the "Investors" section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in
About Vafseo® (vadadustat) tablets
Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries.
INDICATION
VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months.
Limitations of Use
- VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.
- VAFSEO is not indicated for use:
- As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.
- In patients with anemia due to CKD not on dialysis.
IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets
WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. |
VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. |
CONTRAINDICATIONS
- Known hypersensitivity to VAFSEO or any of its components
- Uncontrolled hypertension
WARNINGS AND PRECAUTIONS
- Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular Access
A rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis.
- Hepatotoxicity
Hepatocellular injury attributed to VAFSEO was reported in less than1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in1.8% ,1.8% , and0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease.
- Hypertension
Worsening of hypertension was reported in14% of VAFSEO and17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in2.7% of VAFSEO and3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed.
- Seizures
Seizures occurred in1.6% of VAFSEO and1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency.
- Gastrointestinal (GI) Erosion
Gastric or esophageal erosions occurred in6.4% of VAFSEO and5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in3.4% of VAFSEO and3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present.
- Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on Dialysis
The safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa.
- Malignancy
VAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in2.2% of VAFSEO and3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies.
ADVERSE REACTIONS
- The most common adverse reactions (occurring at ≥
10% ) were hypertension and diarrhea.
DRUG INTERACTIONS
- Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.
- Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.
- BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.
- Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: Breastfeeding not recommended until two days after the final dose.
- Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide.
IMPORTANT
CONTRAINDICATION
AURYXIA (ferric citrate) is contraindicated in patients with iron overload syndromes, e.g., hemochromatosis.
WARNINGS AND PRECAUTIONS
- Iron Overload: Increases in serum ferritin and transferrin saturation (TSAT) were observed in clinical trials with AURYXIA in patients with chronic kidney disease (CKD) on dialysis treated for hyperphosphatemia, which may lead to excessive elevations in iron stores. Assess iron parameters prior to initiating AURYXIA and monitor while on therapy. Patients receiving concomitant intravenous (IV) iron may require a reduction in dose or discontinuation of IV iron therapy.
- Risk of Overdosage in Children Due to Accidental Ingestion: Accidental ingestion and resulting overdose of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Advise patients of the risks to children and to keep AURYXIA out of the reach of children.
ADVERSE REACTIONS
Most common adverse reactions with AURYXIA were:
- 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% ), abdominal pain (5% ) and hyperkalemia (5% ).
SPECIFIC POPULATIONS
- Pregnancy and Lactation: There are no available data on AURYXIA use in pregnant women to inform a drug-associated risk of major birth defects and miscarriage. However, an overdose of iron in pregnant women may carry a risk for spontaneous abortion, gestational diabetes and fetal malformation. Data from rat studies have shown the transfer of iron into milk, hence, there is a possibility of infant exposure when AURYXIA is administered to a nursing woman.
To report suspected adverse reactions, contact Akebia Therapeutics at 1-844-445-3799.
Please click to see the full Prescribing Information for AURYXIA.
Forward-Looking Statements
Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the
The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: whether Vafseo will be commercially available when expected; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; the direct or indirect impact of the COVID-19 pandemic on the markets and communities in which Akebia and its partners, collaborators, vendors and customers operate; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, and other filings that Akebia may make with the
Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
AKEBIA THERAPEUTICS, INC. | |||
Unaudited Condensed Consolidated Statements of Operations | |||
Three Months Ended June 30, | |||
(in thousands, except per share data) | 2024 | 2023 | |
Revenues | |||
Product revenue, net | $ 41,209 | $ 42,244 | |
License, collaboration and other revenue | 2,439 | 14,132 | |
Total revenues | 43,648 | 56,376 | |
Cost of goods sold | |||
Cost of product and other revenue | 8,036 | 8,273 | |
Amortization of intangible asset | 9,011 | 9,011 | |
Total cost of goods sold | 17,047 | 17,284 | |
Operating expenses | |||
Research and development | 7,647 | 20,197 | |
Selling, general and administrative | 26,917 | 27,036 | |
License | 762 | 949 | |
Restructuring | — | (94) | |
Total operating expenses | 35,326 | 48,088 | |
Loss from operations | (8,725) | (8,996) | |
Other expense, net | (2,188) | (1,652) | |
Change in fair value of warrant liability | 2,331 | — | |
Loss on termination of lease | — | (524) | |
Net loss | $ (8,582) | $ (11,172) | |
Net loss per share - basic and diluted | |||
Weighted-average number of common shares - basic and diluted | 209,705,397 | 186,817,431 | |
Unaudited Selected Balance Sheet Data | |||
(in thousands) | June 30, 2024 | December 31, 2023 | |
Cash and cash equivalents | $ 39,499 | $ 42,925 | |
Working capital | $ 4,797 | $ 18,279 | |
Total assets | $ 220,196 | $ 241,703 | |
Total stockholders' (deficit) equity | $ (33,754) | $ (30,584) | |
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SOURCE Akebia Therapeutics, Inc.
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