2020 Q4 Form 10-Q Financial Statement

#000162828020015733 Filed on November 05, 2020

View on sec.gov

Income Statement

Concept 2020 Q4 2020 Q3 2019 Q3
Revenue $56.70M $59.99M $91.98M
YoY Change -18.53% -34.78% 72.99%
Cost Of Revenue $63.23M $30.35M $38.26M
YoY Change 65.76% -20.69%
Gross Profit -$300.0K $29.64M $53.71M
YoY Change -100.76% -44.81%
Gross Profit Margin -0.53% 49.41% 58.4%
Selling, General & Admin $40.30M $40.17M $34.18M
YoY Change -10.24% 17.53% 229.33%
% of Gross Profit 135.52% 63.63%
Research & Development $37.60M $46.86M $74.51M
YoY Change -53.23% -37.11% 5.49%
% of Gross Profit 158.07% 138.72%
Depreciation & Amortization $7.730M $500.0K $600.0K
YoY Change -20.23% -16.67% 200.0%
% of Gross Profit 1.69% 1.12%
Operating Expenses $78.87M $87.74M $109.6M
YoY Change -37.55% -19.96% 35.31%
Operating Profit -$85.40M -$58.10M -$55.91M
YoY Change -10.0% 3.92% 100.79%
Interest Expense -$2.300M -$2.274M $228.0K
YoY Change 187.5% -1097.37% -87.19%
% of Operating Profit
Other Income/Expense, Net -$1.597M -$1.864M $43.00K
YoY Change 18.82% -4434.88% -97.61%
Pretax Income -$87.00M -$59.96M -$55.86M
YoY Change -9.56% 7.33% 114.47%
Income Tax $0.00 $0.00 -$1.277M
% Of Pretax Income
Net Earnings -$87.00M -$59.96M -$54.59M
YoY Change -7.92% 9.85% 109.56%
Net Earnings / Revenue -153.44% -99.95% -59.35%
Basic Earnings Per Share -$0.42
Diluted Earnings Per Share -$599.2K -$0.42 -$459.2K
COMMON SHARES
Basic Shares Outstanding 144.5M shares 143.3M shares
Diluted Shares Outstanding 143.3M shares

Balance Sheet

Concept 2020 Q4 2020 Q3 2019 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $268.7M $269.3M $145.6M
YoY Change 81.93% 84.94% -61.19%
Cash & Equivalents $228.7M $169.3M $122.9M
Short-Term Investments $40.00M $100.0M $22.73M
Other Short-Term Assets $14.90M $9.000M $7.800M
YoY Change 125.76% 15.38% 16.42%
Inventory $61.02M $88.24M $116.0M
Prepaid Expenses
Receivables $26.85M $24.47M $29.65M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $371.4M $391.0M $299.0M
YoY Change 20.0% 30.77% -24.78%
LONG-TERM ASSETS
Property, Plant & Equipment $8.622M $8.821M $12.80M
YoY Change -16.94% -31.08% 236.82%
Goodwill $55.10M $55.10M $55.05M
YoY Change 0.0% 0.09%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $37.98M $44.17M $97.91M
YoY Change -50.02% -54.89% 3816.28%
Total Long-Term Assets $272.7M $285.1M $496.2M
YoY Change -40.93% -42.54% 7776.38%
TOTAL ASSETS
Total Short-Term Assets $371.4M $391.0M $299.0M
Total Long-Term Assets $272.7M $285.1M $496.2M
Total Assets $644.1M $676.1M $795.2M
YoY Change -16.48% -14.97% 96.93%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $41.31M $40.40M $64.36M
YoY Change 5.33% -37.23% 406.79%
Accrued Expenses $130.6M $123.0M $126.6M
YoY Change 1.2% -2.86% 33.87%
Deferred Revenue $15.21M $18.03M $32.14M
YoY Change -61.8% -43.89% -54.15%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00
YoY Change
Total Short-Term Liabilities $187.1M $181.5M $223.1M
YoY Change -10.08% -18.68% 25.79%
LONG-TERM LIABILITIES
Long-Term Debt $96.38M $76.61M $0.00
YoY Change 27.14%
Other Long-Term Liabilities $60.61M $40.97M $30.06M
YoY Change 100.55% 36.3% -64.17%
Total Long-Term Liabilities $157.0M $117.6M $30.06M
YoY Change 48.06% 291.15% -64.17%
TOTAL LIABILITIES
Total Short-Term Liabilities $187.1M $181.5M $223.1M
Total Long-Term Liabilities $157.0M $117.6M $30.06M
Total Liabilities $396.5M $358.2M $327.7M
YoY Change 5.33% 9.32% 25.4%
SHAREHOLDERS EQUITY
Retained Earnings -$1.178B -$1.091B -$699.6M
YoY Change 48.29% 55.88%
Common Stock $1.425B $1.408B
YoY Change 19.88%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $247.6M $318.0M $467.6M
YoY Change
Total Liabilities & Shareholders Equity $644.1M $676.1M $795.2M
YoY Change -16.48% -14.97% 96.93%

Cashflow Statement

Concept 2020 Q4 2020 Q3 2019 Q3
OPERATING ACTIVITIES
Net Income -$87.00M -$59.96M -$54.59M
YoY Change -7.92% 9.85% 109.56%
Depreciation, Depletion And Amortization $7.730M $500.0K $600.0K
YoY Change -20.23% -16.67% 200.0%
Cash From Operating Activities -$30.78M -$27.24M $10.99M
YoY Change -66.59% -347.86% -188.13%
INVESTING ACTIVITIES
Capital Expenditures -$320.0K $50.00K -$2.530M
YoY Change 45.45% -101.98% 716.13%
Acquisitions
YoY Change
Other Investing Activities $60.00M -$49.98M $26.92M
YoY Change 166.67% -285.66% 138.02%
Cash From Investing Activities $59.69M -$49.94M $24.39M
YoY Change 167.91% -304.76% 121.53%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 30.51M 1.050M 190.0K
YoY Change -67.69% 452.63% -47.22%
NET CHANGE
Cash From Operating Activities -30.78M -27.24M 10.99M
Cash From Investing Activities 59.69M -49.94M 24.39M
Cash From Financing Activities 30.51M 1.050M 190.0K
Net Change In Cash 59.42M -76.13M 35.57M
YoY Change 141.84% -314.03% -3333.64%
FREE CASH FLOW
Cash From Operating Activities -$30.78M -$27.24M $10.99M
Capital Expenditures -$320.0K $50.00K -$2.530M
Free Cash Flow -$30.46M -$27.29M $13.52M
YoY Change -66.86% -301.85% -211.18%

Facts In Submission

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Nature of Organization and Operations<div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. Akebia is a biopharmaceutical company with the purpose of bettering the lives of people living with kidney disease. Akebia’s lead investigational product candidate, vadadustat, is an oral therapy in Phase 3 development for the treatment of anemia due to chronic kidney disease, or CKD. Vadadustat is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor, or HIF-PHI, 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, or HIF, which can lead to red blood cell, or RBC, production and improved oxygen delivery to tissues.Vadadustat is approved and marketed in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients under the trade name VAFSEO. In addition, the Company has a commercial product, Auryxia</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;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:120%"> (ferric citrate), which is currently approved by the U.S. Food and Drug Administration, or FDA, and marketed for two indications in the United States: the control of serum phosphorus levels in adult patients with CKD on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD. Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with DD-CKD and NDD-CKD under the trade name Riona</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:6.5pt;font-weight:400;line-height:120%;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:120%"> (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:120%">Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, 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 to the Company’s Japanese partners Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively, JT and Torii, on December 12, 2018 following the consummation of a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger. Additionally, following regulatory approval of vadadustat in Japan, the Company began recognizing royalty revenues from Mitsubishi Tanabe Pharma Corporation, or MTPC, from the sale of VAFSEO since August 2020. The Company has not generated a profit to date and may never generate profits from product sales. The Company’s 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 its product candidates. If the Company does not successfully commercialize any of its products or product candidates, it may be unable to achieve profitability.</span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:12pt;font-weight:400;line-height:120%"> </span></div><div><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">The Company’s management completed its going concern assessment in accordance with 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:120%">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:120%">, or ASC 205-40. The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plan beyond the next twelve months from the filing of this Quarterly Report on Form 10-Q, as required by ASC 205-40. There can be no assurance, however, that the current operating plan will be achieved in the time frame anticipated by the Company, or that its cash resources will fund the Company’s 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. The Company will require additional capital to pursue development and commercial activities related to expanded indications for current products and any additional products and product candidates. The Company expects to finance future cash needs through product revenue, public or private equity or debt transactions, payments from its collaborators, royalty transactions, strategic transactions, or a combination of these approaches. However, adequate additional financing may not be available to the Company on acceptable terms, or at all. If the Company is unable to raise capital in sufficient amounts when needed or on attractive terms, it may not be able to pursue development and commercial activities related to expanded indications for current products and any additional products and product candidates.</span></div>
akba Operating Plan Sufficiently Funded By Cash Resources Period
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<div style="margin-bottom:6pt"><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;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 U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results may differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies and controls, and in developing the estimates and assumptions that are used in the preparation of these financial statements. 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. Estimates are used in the following areas, among others: prepaid and accrued research and development expense, operating lease assets and liabilities, derivative liabilities, other non-current liabilities, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, inventories, income taxes, intangible assets and goodwill. The Company has made estimates of the impact of COVID-19 within the unaudited condensed consolidated financial statements and there may be changes to those estimates in future periods including changes to sales, payer mix, reserves and allowances, intangible assets and goodwill. While the COVID-19 pandemic has not had a material adverse impact on the Company’s financial condition, the future impacts of the pandemic and any resulting economic impact is largely unknown and rapidly evolving.</span></div>
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CY2020Q3 us-gaap Common Stock Par Or Stated Value Per Share
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CY2020Q3 us-gaap Common Stock Shares Issued
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CY2019Q4 us-gaap Common Stock Shares Issued
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CY2019Q4 us-gaap Common Stock Shares Outstanding
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CY2020Q3 us-gaap Preferred Stock Shares Authorized
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CY2020Q3 us-gaap Preferred Stock Shares Issued
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CY2019Q4 us-gaap Preferred Stock Shares Outstanding
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0 shares
CY2020Q3 us-gaap Preferred Stock Shares Outstanding
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CY2019Q4 us-gaap Preferred Stock Shares Issued
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CY2020Q3 us-gaap Common Stock Capital Shares Reserved For Future Issuance
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24800299 shares
CY2019Q4 us-gaap Common Stock Capital Shares Reserved For Future Issuance
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21403890 shares
CY2020Q3 us-gaap Allocated Share Based Compensation Expense
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6592000 USD
CY2019Q3 us-gaap Allocated Share Based Compensation Expense
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2613000 USD
us-gaap Allocated Share Based Compensation Expense
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18372000 USD
us-gaap Allocated Share Based Compensation Expense
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6991000 USD
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2613000 USD
us-gaap Allocated Share Based Compensation Expense
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18372000 USD
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6991000 USD
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447000 USD
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1700000 USD
us-gaap Operating Lease Payments
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5300000 USD
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307000 USD
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akba Long Term Purchase Commitment Period Increase Decrease
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10800000 USD
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119800000 USD
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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16163054 shares
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13128410 shares

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