Press Release
Akebia Therapeutics Reports Third Quarter 2023 Financial Results and Recent Business Highlights
Akebia to host conference call at
- Vadadustat NDA assigned a PDUFA date of
March 27, 2024 - Vadadustat approved in 36 countries, including
Australia andTaiwan - Akebia strengthens cash position modifying Pharmakon loan
- Auryxia® (ferric citrate) quarterly net product revenue of
$40.1 million
In September, Akebia completed its resubmission to its New Drug Application for vadadustat to the
"Akebia is extremely well-positioned following the acceptance of our vadadustat NDA resubmission, with a
Auryxia® (ferric citrate) net product revenue for the third quarter was
Third Quarter 2023 and Recent Business Highlights
Australia's Therapeutic Goods Administration granted approval for Vafseo® (vadadustat) for the treatment of anemia associated with CKD in adults on chronic maintenance dialysis. Vadadustat was also authorized for use inTaiwan during this time, marking approval in 36 countries.- Akebia supported five posters presented at the
American Society of Nephrology Kidney Week 2023, which took place onNovember 2-5, 2023 . Notably, one poster presented data on a potential alternative dosing regimen for vadadustat. - Akebia modified the terms of its loan agreement with
Pharmakon Advisors , LP to extend the maturity of the loan fromNovember 2024 untilMarch 2025 , and to defer its principal payments untilOctober 31, 2024 .
Third Quarter Financial Results
Total Revenues: Total revenues were
Net Product Revenues: Net product revenues were
License, Collaboration and Other Revenues: License, collaboration and other revenues were
Cost of Goods Sold (COGS): COGS was
Research and Development (R&D) Expenses: R&D expenses were
Selling, General and Administrative (SG&A) Expenses: SG&A expenses were
Net Loss: Net loss was
Cash Position: Cash, cash equivalents and restricted cash as of
Conference Call Information
Akebia will host a conference call and webcast on
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
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxia-inducible factor, which can lead to increased red blood cell production and improved oxygen delivery to tissues. Vadadustat is not approved by the
IMPORTANT SAFETY INFORMATION FOR VAFSEO (vadadustat)
For safety information, view the European Summary of Product Characteristics (SPC/SmPC) for Vafseo® (vadadustat) at https://ec.europa.eu/health/documents/community-register/2023/20230424158854/anx_158854_en.pdf, https://products.mhra.gov.uk/ and https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/authorisations/swisspar.html and will be available via the
IMPORTANT
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
Please click to see the full Prescribing Information for AURYXIA.
Forward-Looking Statements
Statements in this press release regarding
Akebia Therapeutics Contact
mcarrasco@akebia.com
|
|||
Unaudited Condensed Consolidated Statements of Operations |
|||
Three Months Ended |
|||
(in thousands, except per share data) |
2023 |
2022 |
|
Revenues |
|||
Product revenue, net |
$ 40,118 |
$ 41,989 |
|
License, collaboration and other revenue |
1,928 |
6,725 |
|
Total revenues |
42,046 |
48,714 |
|
Cost of goods sold |
|||
Product |
8,998 |
29,270 |
|
Amortization of intangible asset |
9,011 |
9,011 |
|
Total cost of goods sold |
18,009 |
38,281 |
|
Operating expenses |
|||
Research and development |
13,330 |
28,028 |
|
Selling, general and administrative |
22,710 |
31,887 |
|
License expense |
864 |
743 |
|
Restructuring |
169 |
180 |
|
Total operating expenses |
37,073 |
60,838 |
|
Loss from operations |
(13,036) |
(50,405) |
|
Other expense, net |
(1,453) |
(2,785) |
|
Loss on extinguishment of debt |
— |
(906) |
|
Net loss |
$ (14,489) |
$ (54,096) |
|
Net loss per share - basic and diluted |
|
|
|
Weighted-average number of common shares - basic and diluted |
188,306 |
183,882 |
|
Unaudited Selected Balance Sheet Data |
|||
(in thousands) |
|
|
|
Cash and cash equivalents |
$ 46,529 |
$ 90,466 |
|
Working capital |
$ 29,900 |
$ 55,646 |
|
Total assets |
$ 234,998 |
$ 356,054 |
|
Total stockholders' (deficit) equity |
$ (39,422) |
$ 5,230 |
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SOURCE
Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax