Press Release
Akebia Reports Fourth Quarter and Full-Year 2020 Financial Results and Provides Business Updates
Akebia also announced a
"2020 was a year of focused execution for Akebia as we advanced vadadustat, our investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), and executed on our commercial priorities. Importantly, we achieved this while continuing to provide patients with access to our therapies and keeping with our goal of maintaining a strong balance sheet," stated
Butler continued, "As we advance vadadustat toward commercialization, subject to approval, we continue to execute on key commercial, development, and financial priorities. As dialysis is a primary focus, we're thrilled to have recently added
Akebia plans to submit a New Drug Application (NDA) to the
Recent Business Highlights:
- In February, the Company 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. - In November, the study design and methodology for Akebia's global Phase 3 INNO2VATE program was published in Nephrology Dialysis Transplantation (NDT).
- In October, the study design and methodology for Akebia's global Phase 3 PRO2TECT program was published in
American Heart Journal . - In October, Akebia completed a pre-NDA meeting with the FDA for vadadustat.
- In October, top-line data from both INNO2VATE and PRO2TECT were presented at
American Society of Nephrology Kidney Week 2020 Reimagined. - In October, Akebia and Otsuka launched Balancing Anemia Due to CKD, a campaign and website designed to increase awareness and education of anemia due to CKD among healthcare providers with the goal of improving the management of this disease for patients.
Fourth Quarter and Full-Year 2020 Financial Results
- Revenues: Total revenue was
$56.7 million for the fourth quarter of 2020 compared to$69.6 million for the fourth quarter of 2019, and$295.3 million for the full-year 2020 compared to$335.0 million for the full-year 2019. The decline in both periods was driven by lower collaboration revenue consistent with the Company successfully completing its global Phase 3 clinical development 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). - Collaboration revenue was
$22.1 million for the fourth quarter of 2020 compared to$40.6 million for the fourth quarter of 2019, and$166.4 million for the full-year 2020 compared with$223.9 million for the full-year 2019. The change in both periods is due to the timing of when vadadustat development expenses are incurred and the associated revenue is recognized on a percentage-of-completion basis. Collaboration revenue for the full-year 2020 includes$0.4 million in royalty revenue related to the commercial sale of Vafseo inJapan from MTPC, which launched in August of 2020. - Net product revenue was
$34.6 million for the fourth quarter of 2020 compared with$28.9 million for the fourth quarter of 2019, an increase of 20 percent. Net product revenue was$128.9 million for the full-year 2020 compared to$111.1 million for the full-year 2019, an increase of 16 percent. While Akebia did not experience a significant impact from COVID-19 on revenues during the first nine months of 2020, the Company believes its revenue growth was negatively impacted during the fourth quarter of 2020 primarily as the kidney patient populations that it serves continue to experience both higher hospitalization and mortality rates due to COVID-19. - COGS: Cost of goods sold was
$63.2 million for the fourth quarter of 2020 compared to$38.1 million for the fourth quarter of 2019. Excluding non-cash purchase accounting adjustments as a result of the merger with Keryx, the increase in the fourth quarter of 2020 was primarily driven by a$14.8 million non-cash charge related to excess purchase commitments. Cost of goods sold was$295.9 million for the full-year 2020, compared with$145.3 million for the full-year 2019. Cost of goods sold for 2020 includes a$115.5 million non-cash charge related to the impairment of the Auryxia intangible asset in the second quarter of 2020, a$25.1 million non-cash charge related to excess purchase commitments, and a$20.1 million non-cash charge for inventory write-downs largely related to a previously disclosed manufacturing quality issue related to Auryxia. - R&D Expenses: Research and development expenses were
$37.6 million for the fourth quarter of 2020 compared to$80.4 million for the fourth quarter of 2019, and$218.5 million for the full-year 2020 compared to$323.0 million for the full-year 2019. The decline in both periods was primarily driven by a decrease in costs consistent with the Company completing the INNO2VATE and PRO2TECT studies. - SG&A Expenses: Selling, general and administrative expenses were
$40.3 million for the fourth quarter of 2020 compared to$44.9 million for the fourth quarter of 2019, and$153.9 million for the full-year 2020 compared to$149.5 million for the full-year 2019. - Net Loss: Net loss was
$87.0 million for the fourth quarter of 2020 compared to$94.5 million for the fourth quarter of 2019, and$383.5 million for the full-year 2020 compared to$279.7 million for the full-year 2019. The increase in net loss for the full-year 2020 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
December 31, 2020 were$268.7 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.
"As COVID-19 continues to adversely and disproportionately impact our patient population with higher hospitalization and mortality rates, we expect this will have a negative impact on future Auryxia revenue growth. While we are unable to fully quantify the impact of the COVID-19 pandemic on future revenues and revenue growth, we continue to work to position the Company to navigate these challenges. As such, our financial priorities remain focused on improving our cost structure and maintaining a strong balance sheet, as evidenced by our recent
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 March 3, 2021. To access the replay, dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and reference conference ID number 5455117. 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
Investor Contact:
ir@akebia.com
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Consolidated Statements of Operations |
|||||||||||||||
(in thousands, except share and per share data) |
|||||||||||||||
(unaudited) |
|||||||||||||||
Three Months Ended |
Twelve Months Ended |
||||||||||||||
|
|
|
|
||||||||||||
Revenues: |
|||||||||||||||
Product revenue, net |
$ |
34,604 |
$ |
28,915 |
$ |
128,901 |
$ |
111,119 |
|||||||
License, collaboration and other revenue |
22,095 |
40,640 |
166,406 |
223,882 |
|||||||||||
Total revenues |
56,699 |
69,555 |
295,307 |
335,001 |
|||||||||||
Cost of goods sold: |
|||||||||||||||
Product |
56,026 |
29,047 |
148,866 |
108,935 |
|||||||||||
Amortization of intangibles |
7,208 |
9,100 |
31,515 |
36,401 |
|||||||||||
Impairment of intangible asset |
— |
— |
115,527 |
— |
|||||||||||
Total cost of goods sold |
63,234 |
38,147 |
295,908 |
145,336 |
|||||||||||
Operating expenses: |
|||||||||||||||
Research and development |
37,578 |
80,412 |
218,485 |
322,969 |
|||||||||||
Selling, general and administrative |
40,311 |
44,918 |
153,947 |
149,455 |
|||||||||||
License expense |
979 |
969 |
3,409 |
3,529 |
|||||||||||
Total operating expenses |
78,868 |
126,299 |
375,841 |
475,953 |
|||||||||||
Operating loss |
(85,403) |
(94,891) |
(376,442) |
(286,288) |
|||||||||||
Other expense, net |
(1,597) |
(1,344) |
(7,015) |
(2) |
|||||||||||
Net loss before income taxes |
(87,000) |
(96,235) |
(383,457) |
(286,290) |
|||||||||||
Benefit from income taxes |
— |
(1,752) |
— |
(6,631) |
|||||||||||
Net loss |
$ |
(87,000) |
$ |
(94,483) |
$ |
(383,457) |
$ |
(279,659) |
|||||||
Net loss per share - basic and diluted |
$ |
(0.60) |
$ |
(0.79) |
$ |
(2.77) |
$ |
(2.36) |
|||||||
Weighted-average number of common shares - basic and diluted |
145,111,415 |
119,358,081 |
138,463,152 |
118,395,919 |
|
|||
Selected Balance Sheet Data |
|||
(in thousands) |
|||
(unaudited) |
|||
|
|
||
Cash, cash equivalents and available for sale securities |
|
|
|
Working capital |
184,291 |
101,415 |
|
Total assets |
644,139 |
771,201 |
|
Total stockholders' equity |
247,618 |
394,757 |
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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