Press Release
Akebia Reports First Quarter 2021 Financial Results and Highlights Recent Company Milestones
"Akebia is off to a great start in 2021, building positive momentum with solid execution on strategic priorities that set the stage for an exciting year. Most importantly, we submitted the vadadustat NDA to the FDA, a significant milestone for Akebia and our partner,
Recent Business Highlights:
- In April, the
New England Journal of Medicine (NEJM) published the results of Akebia's global Phase 3 program for vadadustat, which consisted of two programs that evaluated the efficacy and safety of vadadustat versus darbepoetin alfa for the treatment of anemia due to CKD in adult patients on dialysis (INNO2VATE) and not on dialysis (PRO2TECT). - In March, Akebia submitted an NDA to the FDA for vadadustat for the treatment of anemia due to CKD in both adult patients on dialysis and adult patients not on dialysis.
- In February, Akebia completed a non-dilutive transaction with an entity managed by
HealthCare Royalty Management, LLC (HCR), to monetize the Company's rights to receive royalties and sales milestones on vadadustat net sales under its collaboration agreement withMitsubishi Tanabe Pharma Corporation (MTPC), with an upfront payment of$45 million . - In February, Akebia announced that
LeAnne M. Zumwalt joined Akebia's Board of Directors.Ms. Zumwalt recently served as Group Vice President, Government Affairs at DaVita Inc. - In February, Akebia launched its Medical Engagement Hub, an online resource dedicated to scientific education and connecting
U.S. healthcare professionals with Akebia Medical Affairs. - In January, the
University of Texas Health Science Center at Houston (UTHealth) inHouston, Texas , announced that it had received$5.1 million in government funding for its study evaluating the use of vadadustat as a potential therapy to prevent and lessen the severity of acute respiratory distress syndrome (ARDS), a complication of COVID-19. This investigator-sponsored research study is currently underway and actively enrolling patients.
First Quarter Financial Results
- Revenues: Total revenue was
$52.3 million for the first quarter of 2021 compared to$88.5 million for the first quarter of 2020. The decrease compared to the same period in 2020 was primarily due to lower collaboration revenue consistent with the Company successfully completing the INNO2VATE and PRO2TECT global Phase 3 clinical programs. - Collaboration revenue was
$21.9 million for the first quarter of 2021 compared to$59.3 million for the first quarter of 2020. - Net product revenue was
$30.4 million for the first quarter of 2021 compared with$29.2 million for the first quarter of 2020, an increase of 4 percent. - COGS: Cost of goods sold was
$34.6 million for the first quarter of 2021 compared to$27.7 million for the first quarter of 2020. The increase was driven by higher non-cash purchase accounting adjustments as a result of the merger with Keryx, and a$5.1 million non-cash charge to inventory reserves related to a previously disclosed manufacturing quality issue related to Auryxia® (ferric citrate), partially offset by an$8.9 million non-cash gain due to a reduction to the liability for excess purchase commitments primarily as a result of the Company having successfully modified certain supply agreements. - R&D Expenses: Research and development expenses were
$40.6 million for the first quarter of 2021 compared to$81.2 million for the first quarter of 2020. The decrease compared to the same period in 2020 was primarily due to the completion of the INNO2VATE and PRO2TECT global Phase 3 clinical programs. - SG&A Expenses: Selling, general and administrative expenses were
$41.3 million for the first quarter of 2021 compared to$38.0 million for the first quarter of 2020. - Net Loss: Net loss was
$69.6 million for the first quarter of 2021 compared to$60.7 million for the first quarter of 2020. The increase in net loss compared to the prior year period was due primarily to lower collaboration revenue and higher cost of goods sold, partially offset by lower operating expenses. - Cash Position: Cash, cash equivalents and available-for-sale securities as of
March 31, 2021 were$272.8 million . The Company expects its cash resources to fund its current operating plan beyond the expectedU.S. launch of vadadustat, assuming timely regulatory approval and the receipt of associated regulatory milestones.
"Despite the ongoing impact of COVID-19 on dialysis patients, we are encouraged by Auryxia's revenue growth in the first quarter of 2021 when compared to the prior year's period. We believe this performance highlights Auryxia's favorable product profile and the critical nature of this therapy, as well as our team's ability to execute at a high level," stated
Conference Call
Akebia will host a conference call at
A replay of the conference call will be available two hours after the completion of the call through May 16, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 6250159. An online archive of the conference call can be accessed via the Investors section of the Company's website at http://ir.akebia.com.
About
About Vadadustat
Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) 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 recently completed its global Phase 3 development program for the treatment of anemia due to CKD. Vadadustat is not approved by the
About Anemia due to Chronic Kidney Disease (CKD)
Anemia is a condition in which a person lacks enough healthy red blood cells to carry adequate oxygen to the body's tissues. It commonly occurs in people with CKD because their kidneys do not produce enough erythropoietin (EPO), a hormone that helps regulate production of red blood cells. Anemia due to CKD can have a profound impact on a person's quality of life as it can cause fatigue, dizziness, shortness of breath and cognitive dysfunction. Left untreated, anemia leads to deterioration in health and is associated with increased morbidity and mortality in people with CKD.
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 see full Prescribing Information
Forward-Looking Statements
Statements in this press release regarding Akebia's strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the
Contact:
IR@akebia.com
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Consolidated Statements of Operations |
|||||||
(in thousands, except share and per share data) |
|||||||
(unaudited) |
|||||||
Three Months Ended |
|||||||
|
|
||||||
Revenues: |
|||||||
Product revenue, net |
$ |
30,408 |
$ |
29,209 |
|||
License, collaboration and other revenue |
21,896 |
59,269 |
|||||
Total revenues |
52,304 |
88,478 |
|||||
Cost of goods sold: |
|||||||
Product |
25,595 |
18,613 |
|||||
Amortization of intangibles |
9,011 |
9,100 |
|||||
Impairment of intangible asset |
— |
— |
|||||
Total cost of goods sold |
34,606 |
27,713 |
|||||
Operating expenses: |
|||||||
Research and development |
40,611 |
81,231 |
|||||
Selling, general and administrative |
41,328 |
37,983 |
|||||
License expense |
695 |
676 |
|||||
Total operating expenses |
82,634 |
119,890 |
|||||
Operating loss |
(64,936) |
(59,125) |
|||||
Other expense, net |
(4,644) |
(1,622) |
|||||
Net loss |
$ |
(69,580) |
$ |
(60,747) |
|||
Net loss per share - basic and diluted |
$ |
(0.45) |
$ |
(0.47) |
|||
Weighted-average number of common shares - basic and diluted |
153,820,809 |
128,395,163 |
|
|||
Selected Balance Sheet Data |
|||
(in thousands) |
|||
(unaudited) |
|||
|
|
||
Cash, cash equivalents and available for sale securities |
|
|
|
Working capital |
192,338 |
184,291 |
|
Total assets |
628,703 |
644,139 |
|
Total stockholders' equity |
213,891 |
247,618 |
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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