2023 Q3 Form 10-Q Financial Statement

#000162828023030698 Filed on August 28, 2023

View on sec.gov

Income Statement

Concept 2023 Q3 2023 Q2 2022 Q4
Revenue $42.05M $56.38M $55.18M
YoY Change -14.13% -55.53% -7.42%
Cost Of Revenue $18.01M $17.28M -$11.25M
YoY Change -52.54% -7.08% -126.56%
Gross Profit $24.04M $39.09M $66.43M
YoY Change 118.18% -63.86% 285.43%
Gross Profit Margin 57.17% 69.34% 120.39%
Selling, General & Admin $22.71M $27.04M $30.65M
YoY Change -26.55% -17.59% -31.63%
% of Gross Profit 94.48% 69.16% 46.13%
Research & Development $13.33M $20.20M $31.90M
YoY Change -51.26% -22.4% 7.94%
% of Gross Profit 55.46% 51.67% 48.02%
Depreciation & Amortization $9.400M $9.011M $9.419M
YoY Change -0.25% -4.4% -0.36%
% of Gross Profit 39.11% 23.05% 14.18%
Operating Expenses $37.07M $48.09M $71.56M
YoY Change -37.37% -35.24% -14.19%
Operating Profit -$13.04M -$8.996M -$5.128M
YoY Change -72.94% -126.54% -92.25%
Interest Expense -$1.410M -$1.642M -$1.636M
YoY Change -64.32% -67.4% -67.81%
% of Operating Profit
Other Income/Expense, Net -$43.00K -$10.00K $434.0K
YoY Change -103.68% -102.43% -22.5%
Pretax Income -$14.50M -$11.17M -$7.552M
YoY Change -72.04% -138.16% -89.31%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$14.49M -$11.17M -$7.552M
YoY Change -72.06% -138.16% -89.31%
Net Earnings / Revenue -34.46% -19.82% -13.69%
Basic Earnings Per Share -$0.08 -$0.06
Diluted Earnings Per Share -$0.08 -$0.06 -$0.04
COMMON SHARES
Basic Shares Outstanding 188.3M shares 185.9M shares 184.0M shares
Diluted Shares Outstanding 188.3M shares 186.8M shares

Balance Sheet

Concept 2023 Q3 2023 Q2 2022 Q4
SHORT-TERM ASSETS
Cash & Short-Term Investments $46.50M $53.57M $90.47M
YoY Change -67.88% -62.77% -39.61%
Cash & Equivalents $46.53M $53.57M $90.47M
Short-Term Investments
Other Short-Term Assets $22.00M $24.40M $33.54M
YoY Change -25.72% -42.09% 1.21%
Inventory $18.44M $20.91M $21.76M
Prepaid Expenses $15.60M $15.60M
Receivables $22.59M $19.57M $39.18M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $109.6M $118.4M $184.9M
YoY Change -53.85% -61.06% -32.01%
LONG-TERM ASSETS
Property, Plant & Equipment $4.023M $4.419M $5.214M
YoY Change -28.44% -26.78% -22.8%
Goodwill $59.00M $59.00M $55.10M
YoY Change 7.08% 7.08% 0.0%
Intangibles $45.05M $54.06M $72.08M
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.862M $3.348M $5.372M
YoY Change -85.3% -90.42% -89.2%
Total Long-Term Assets $125.4M $135.3M $166.9M
YoY Change -36.79% -37.85% -34.18%
TOTAL ASSETS
Total Short-Term Assets $109.6M $118.4M $184.9M
Total Long-Term Assets $125.4M $135.3M $166.9M
Total Assets $235.0M $253.7M $351.8M
YoY Change -46.09% -51.38% -33.05%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $9.038M $11.78M $18.02M
YoY Change -54.14% -52.79% -46.35%
Accrued Expenses $62.66M $56.41M $71.00M
YoY Change -28.27% -38.21% -32.03%
Deferred Revenue $0.00 $0.00 $3.738M
YoY Change -100.0% -100.0% -82.12%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $8.000M $24.00M $32.00M
YoY Change -87.87% -75.55% -67.19%
Total Short-Term Liabilities $79.70M $92.18M $124.8M
YoY Change -57.6% -60.55% -51.36%
LONG-TERM LIABILITIES
Long-Term Debt $34.61M $18.49M $34.08M
YoY Change
Other Long-Term Liabilities $9.415M $17.14M $12.16M
YoY Change -87.33% -74.37% -85.26%
Total Long-Term Liabilities $44.03M $35.63M $46.24M
YoY Change -40.75% -46.74% -43.97%
TOTAL LIABILITIES
Total Short-Term Liabilities $79.70M $92.18M $124.8M
Total Long-Term Liabilities $44.03M $35.63M $46.24M
Total Liabilities $274.4M $280.5M $342.5M
YoY Change -34.98% -38.95% -23.74%
SHAREHOLDERS EQUITY
Retained Earnings -$1.610B -$1.595B -$1.553B
YoY Change 4.15% 6.8% 6.34%
Common Stock $1.570B $1.568B $1.562B
YoY Change 0.7% 0.8% 1.66%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity -$39.42M -$26.81M $9.342M
YoY Change
Total Liabilities & Shareholders Equity $235.0M $253.7M $351.8M
YoY Change -46.09% -51.38% -33.05%

Cashflow Statement

Concept 2023 Q3 2023 Q2 2022 Q4
OPERATING ACTIVITIES
Net Income -$14.49M -$11.17M -$7.552M
YoY Change -72.06% -138.16% -89.31%
Depreciation, Depletion And Amortization $9.400M $9.011M $9.419M
YoY Change -0.25% -4.4% -0.36%
Cash From Operating Activities -$7.170M $3.629M -$54.68M
YoY Change -121.21% -111.84% -12.94%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 $0.00
YoY Change
Acquisitions
YoY Change
Other Investing Activities $0.00
YoY Change
Cash From Investing Activities $0.00 $0.00 $0.00
YoY Change
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 50.00K -8.000M -1.000K
YoY Change -100.15% 88788.89% -100.02%
NET CHANGE
Cash From Operating Activities -7.170M 3.629M -54.68M
Cash From Investing Activities 0.000 0.000 0.000
Cash From Financing Activities 50.00K -8.000M -1.000K
Net Change In Cash -7.120M -4.371M -54.68M
YoY Change -920.28% -85.75% -4.75%
FREE CASH FLOW
Cash From Operating Activities -$7.170M $3.629M -$54.68M
Capital Expenditures $0.00 $0.00 $0.00
Free Cash Flow -$7.170M $3.629M -$54.68M
YoY Change -121.21% -111.84% -12.94%

Facts In Submission

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NATURE OF BUSINESS<div style="margin-top:12pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a fully integrated biopharmaceutical company with the purpose of bettering the lives of people impacted by kidney disease. The Company has one commercial product, Auryxia</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:112%;position:relative;top:-3.5pt;vertical-align:baseline">®</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%"> (ferric citrate), which is approved by the U.S. Food and Drug Administration (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">FDA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">), and marketed for two indications in the United States: the control of serum phosphorus levels in adult patients with chronic kidney disease (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">CKD)</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%"> on dialysis (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">DD-CKD</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">), and the treatment of iron deficiency anemia (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">IDA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) in adult patients with CKD not on dialysis (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">NDD-CKD</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">). Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients for the improvement of hyperphosphatemia in such patients with DD-CKD and NDD-CKD under the trade name Riona (ferric citrate hydrate).</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">Vadadustat, the Company’s lead investigational product candidate, is an investigational oral hypoxia-inducible factor prolyl hydroxylase (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">HIF-PH</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">), inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. On March 29, 2022, the Company received a complete response letter (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">CRL</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) from the FDA. The CRL provided that the FDA had completed its review of the Company's new drug application (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">NDA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) for vadadustat for the treatment of anemia due to CKD in adult patients and had determined that it could not approve the NDA in its present form. In October 2022, the Company submitted a Formal Dispute Resolution Request with the FDA and focused on the favorable balance between the benefits and risks of vadadustat for the treatment of anemia due to CKD in adult DD-CKD patients in light of safety concerns expressed by the FDA in the CRL for dialysis patients related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for vadadustat compared to the active comparator and the risk of drug-induced liver injury. In May 2023, the Office of New Drugs (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">OND</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) denied the Company's appeal but provided a path forward for the Company to resubmit the NDA for vadadustat for the treatment of anemia due to CKD for dialysis dependent patients without the need for the Company to generate additional clinical data.</span><span style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%"> </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In July 2023, the Company held an End of Dispute Type A meeting with the FDA to align on the contents of the NDA resubmission. The Company expects to resubmit the NDA by the end of the third quarter of 2023, with a potential Prescription Drug User Fee Act (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">PDUFA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) date that the Company projects will be in March 2024. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In October 2021, the Company's former collaboration partner, Otsuka Pharmaceutical Co. Ltd. (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">Otsuka</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">), submitted a Marketing Authorization Application (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">MAA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) for vadadustat for the treatment of anemia due to CKD in adult patients with DD-CKD and NDD-CKD to the European Medicines Agency (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">EMA</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">)</span><span style="color:#0000ff;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">In connection with the Termination and Settlement Agreement with Otsuka dated June 30, 2022 (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">Termination Agreement</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">), Otsuka transferred the MAA for vadadustat with each of the EMA, the United Kingdom, Switzerland and Australia to the Company. In April 2023, the European Commission (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">EC</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) approved the marketing authorization of vadadustat under the trade name Vafseo for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. In May 2023, the United Kingdom (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">UK</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">) Medicines and Healthcare products Regulatory Agency approved the marketing authorization of vadadustat under the trade name Vafseo for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. In June 2023, the Swiss Agency for Therapeutics Products approved the marketing authorization for vadadustat under the trade name Vafseo for the treatment of symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. Vadadustat is approved in Japan as a treatment for anemia due to CKD in both DD-CKD and NDD-CKD patients under the trade name Vafseo,</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:112%;position:relative;top:-3.5pt;vertical-align:baseline"> </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">and marketed and sold in Japan by Mitsubishi Tanabe Pharma Corporation (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%;text-decoration:underline">MTPC</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">). Vadadustat is also approved in Korea as a treatment for anemia due to CKD in DD-CKD patients.</span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:115%">In addition, the Company continues to explore additional development opportunities to expand its pipeline and portfolio of novel therapeutics. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, commercializing Auryxia, and providing general and administrative support for these operations. The Company began recording revenue from the U.S. sales of Auryxia and revenue from sublicensing rights to Auryxia in Japan from the Company’s Japanese partners, Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd. (collectively, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">JT and Torii</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">), in December 2018. Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from MTPC from the sale of Vafseo in August 2020. In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P. (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">HCR</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">) (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">Royalty Agreement</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">), whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC (</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%;text-decoration:underline">MTPC Agreement</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">), subject to certain caps and other terms and conditions (see Note 6 for additional information). The Company has not generated a profit to date, and may never generate profits, from product sales. Vadadustat and the Company’s other potential product candidates are subject to long development cycles, and the Company may be unsuccessful in its efforts to develop, obtain marketing approval for or market vadadustat and its other potential product candidates. If the Company does not successfully commercialize Auryxia, vadadustat, if approved, or any other potential product candidate, it may be unable to achieve profitability.</span></div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company’s management completed its going concern assessment in accordance with Accounting Standards Codification, or ASC, 205-40, </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:400;line-height:112%">Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">, or ASC 205-40. As of June 30, 2023, the Company had cash and cash equivalents of approximately $53.6 million. </span><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">Based on its current operating plan, the Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan through at least the next twelve months from the filing of this Quarterly Report on Form 10-Q. If the Company’s operating performance deteriorates significantly from the levels expected in the Company’s operating plan, it would have an effect on the Company’s liquidity and its ability to continue as a going concern in the future. </span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">The Company expects to finance future cash needs through product revenue, potential strategic transactions, public or private equity or debt transactions, operating expense management, or a combination of these approaches. Assuming the Company is successful in executing its operating plan, the Company will require additional funding to fund its strategic growth beyond Auryxia or to pursue later stage development and commercial activities for its product candidates and any additional product or product candidates, including those that may be in-licensed or acquired. There can be no assurance that the current operating plan will be achieved in the time frame anticipated by the Company, or that its cash resources will fund its operating plan for the period anticipated by the Company, or that additional funding will be available on terms acceptable to the Company, or at all.</span>
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<div style="margin-bottom:6pt;margin-top:6pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-style:italic;font-weight:700;line-height:120%">Use of Estimates</span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, revenue and expenses, and the disclosure of contingent assets and liabilities as of and during the reported period. Management bases its estimates and assumptions on historical experience when available and on various factors that it believes to be reasonable under the circumstances. In certain circumstances, management must apply significant judgment in this process. In addition, other factors may affect estimates, including expected business and operational changes, sensitivity and volatility associated with the assumptions used in developing estimates, and whether historical trends are expected to be representative of future trends. The estimation process often may yield a range of potentially reasonable estimates of the ultimate future outcomes, and management must select an amount that falls within that range of reasonable estimates. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to: prepaid and accrued research and development expense, right-of-use assets and liabilities, embedded debt derivative, refund liabilities to customers, other long-term liabilities, stock-based compensation expense, and certain judgments regarding product and collaboration revenues including various rebates, returns and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, inventories, income taxes, intangible asset and goodwill. </span></div><div><span><br/></span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Although the Company regularly assesses these estimates, actual results could differ materially from these estimates. Changes in estimates are recorded in the period they become known.</span></div>
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akba-20230630.htm Edgar Link pending
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