2019 Q2 Form 10-Q Financial Statement

#000156459019017969 Filed on May 09, 2019

View on sec.gov

Income Statement

Concept 2019 Q2 2019 Q1 2018 Q1
Revenue $100.8M $72.67M $45.90M
YoY Change 106.59% 58.31% 119.62%
Cost Of Revenue $37.67M $31.26M
YoY Change
Gross Profit $63.13M $41.41M
YoY Change
Gross Profit Margin 62.63% 56.99%
Selling, General & Admin $36.07M $34.29M $9.024M
YoY Change 187.67% 280.0% 55.59%
% of Gross Profit 57.13% 82.81%
Research & Development $85.69M $82.35M $61.40M
YoY Change 19.16% 34.11% 2.34%
% of Gross Profit 135.73% 198.87%
Depreciation & Amortization $600.0K $439.0K $199.0K
YoY Change 200.0% 120.6% 47.41%
% of Gross Profit 0.95% 1.06%
Operating Expenses $122.7M $117.4M $70.43M
YoY Change 45.23% 66.66% 6.97%
Operating Profit -$59.52M -$75.97M -$24.50M
YoY Change 66.91% 210.1% -45.53%
Interest Expense $485.0K $869.0K $1.076M
YoY Change -68.93% -19.24% 147.36%
% of Operating Profit
Other Income/Expense, Net $508.0K $791.0K $1.080M
YoY Change -68.11% -26.76% 151.75%
Pretax Income -$59.02M -$75.18M -$23.42M
YoY Change 73.06% 221.03% -47.38%
Income Tax -$845.0K -$2.757M $0.00
% Of Pretax Income
Net Earnings -$58.17M -$72.42M -$23.42M
YoY Change 70.74% 209.25% -47.43%
Net Earnings / Revenue -57.71% -99.66% -51.02%
Basic Earnings Per Share
Diluted Earnings Per Share -$492.0K -$618.3K -$481.5K
COMMON SHARES
Basic Shares Outstanding 117.9M 117.1M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q2 2019 Q1 2018 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $136.8M $168.0M $349.4M
YoY Change -63.03% -51.91% 38.77%
Cash & Equivalents $87.21M $62.74M $158.2M
Short-Term Investments $49.55M $105.3M $191.3M
Other Short-Term Assets $28.60M $15.60M $8.100M
YoY Change 450.0% 92.59% 153.13%
Inventory $122.1M $115.2M
Prepaid Expenses
Receivables $28.89M $48.40M $35.90M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $316.4M $347.2M $437.0M
YoY Change -22.34% -20.55% 71.31%
LONG-TERM ASSETS
Property, Plant & Equipment $10.90M $41.90M $3.700M
YoY Change 194.68% 1032.43% 27.59%
Goodwill $55.05M $55.05M
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $100.5M $128.1M $2.000M
YoY Change 3766.88% 6304.15% 53.85%
Total Long-Term Assets $507.1M $543.6M $5.700M
YoY Change 7823.94% 9436.72% 35.71%
TOTAL ASSETS
Total Short-Term Assets $316.4M $347.2M $437.0M
Total Long-Term Assets $507.1M $543.6M $5.700M
Total Assets $823.5M $890.8M $442.7M
YoY Change 99.02% 101.22% 70.73%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $19.32M $15.23M $17.90M
YoY Change 302.52% -14.94% 18.54%
Accrued Expenses $126.0M $137.8M $54.00M
YoY Change 55.53% 155.19% 57.43%
Deferred Revenue $40.32M $49.58M
YoY Change -48.72%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $185.6M $202.6M $151.4M
YoY Change 12.89% 33.83% 13.41%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change
Other Long-Term Liabilities $29.90M $117.9M $94.20M
YoY Change -64.15% 25.16% -1.05%
Total Long-Term Liabilities $29.90M $117.9M $94.20M
YoY Change -64.15% 25.16% -1.05%
TOTAL LIABILITIES
Total Short-Term Liabilities $185.6M $202.6M $151.4M
Total Long-Term Liabilities $29.90M $117.9M $94.20M
Total Liabilities $304.2M $324.4M $245.6M
YoY Change 22.7% 32.08% 7.44%
SHAREHOLDERS EQUITY
Retained Earnings -$645.0M
YoY Change
Common Stock $1.164B
YoY Change 95.79%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $519.4M $566.4M $197.1M
YoY Change
Total Liabilities & Shareholders Equity $823.5M $890.8M $442.7M
YoY Change 99.02% 101.22% 70.73%

Cashflow Statement

Concept 2019 Q2 2019 Q1 2018 Q1
OPERATING ACTIVITIES
Net Income -$58.17M -$72.42M -$23.42M
YoY Change 70.74% 209.25% -47.43%
Depreciation, Depletion And Amortization $600.0K $439.0K $199.0K
YoY Change 200.0% 120.6% 47.41%
Cash From Operating Activities -$38.37M -$137.9M -$20.33M
YoY Change -526.33% 578.45% 113.33%
INVESTING ACTIVITIES
Capital Expenditures -$1.980M $1.928M $296.0K
YoY Change 1064.71% 551.35% -30.68%
Acquisitions
YoY Change
Other Investing Activities $56.01M $112.4M $12.73M
YoY Change -1752.21% 782.95% -113.86%
Cash From Investing Activities $54.04M $110.5M $12.43M
YoY Change -1617.98% 788.48% -113.47%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 8.810M -14.45M 95.91M
YoY Change 4095.24% -115.06% 5380.63%
NET CHANGE
Cash From Operating Activities -38.37M -137.9M -20.33M
Cash From Investing Activities 54.04M 110.5M 12.43M
Cash From Financing Activities 8.810M -14.45M 95.91M
Net Change In Cash 24.48M -41.90M 88.02M
YoY Change 333.27% -147.61% -187.94%
FREE CASH FLOW
Cash From Operating Activities -$38.37M -$137.9M -$20.33M
Capital Expenditures -$1.980M $1.928M $296.0K
Free Cash Flow -$36.39M -$139.9M -$20.63M
YoY Change -496.84% 578.06% 107.15%

Facts In Submission

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<p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-weight:bold;color:#000000;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">1. Nature of Organization and Operations</font></p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Akebia Therapeutics, Inc., referred to as Akebia or the Company, was incorporated in the State of Delaware in 2007. <font style="Background-color:#FFFFFF;color:#000000;">Akebia is a biopharmaceutical company focused on the development and commercialization of therapeutics for patients with kidney disease. Akebia&#8217;s commercial product, Auryxia<sup style="font-size:85%; vertical-align:top">&#174;</sup> (ferric citrate) is currently approved by the United States Food and Drug Administration, or FDA, and marketed for two indications in the United States, or the U.S., the control of serum phosphorus levels in adult patients with chronic kidney disease, or 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. </font>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<sup style="font-size:85%; vertical-align:top">&#174;</sup> (ferric citrate hydrate) and is approved, but not currently marketed, in the European Union as an oral treatment for the control of hyperphosphatemia in adult patients with DD-CKD and NDD-CKD under the trade name Fexeric<sup style="font-size:85%; vertical-align:top">&#174;</sup><sup style="font-size:85%; vertical-align:top"> </sup>(ferric citrate). <font style="Background-color:#FFFFFF;color:#000000;">The Company&#8217;s lead investigational product candidate, vadadustat, is an oral therapy in Phase 3 development for two indications: anemia due to CKD in adult patients with DD-CKD and anemia due to CKD in adult patients with NDD-CKD.&nbsp;&nbsp;The Company believes vadadustat has the potential to set a new standard of care in the treatment of anemia due to CKD, acting via a novel hypoxia inducible factor, or HIF, pathway. HIF is the primary regulator of the production of red blood cells, or RBCs, in the body, as well as other important metabolic functions.</font></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">On December 12, 2018, the Company completed a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger. Pursuant to the terms and conditions of the Agreement and Plan of Merger, or the Merger Agreement, each share of Keryx common stock, or Keryx Share, issued and outstanding immediately prior to the effective time of the Merger, or the Effective Time, was cancelled and converted into 0.37433, or the Exchange Multiplier, fully paid and non-assessable shares of Akebia common stock, or Akebia Shares, resulting in the issuance of an aggregate of 59,270,410 Akebia Shares. The Merger Agreement also provided that at the Effective Time, each Keryx restricted share award, to the extent outstanding, other than those Keryx restricted share awards that accelerated or lapsed as a result of the completion of the Merger, converted into an Akebia restricted stock unit, or RSU, award covering the number of Akebia Shares determined in accordance with the Exchange Multiplier, resulting in the issuance of Akebia RSUs covering an aggregate of 602,752 Akebia Shares. In addition, each outstanding and unexercised option to acquire Keryx Shares converted into an option to acquire Akebia Shares, with the number of shares and exercise price adjusted by the Exchange Multiplier, resulting in the assumption by Akebia of options to acquire an aggregate 3,967,290 Akebia Shares</font>. </p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Since inception, the Company has devoted most of its resources to research and development, including its preclinical and clinical development activities, raising capital, 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&#8217;s Japanese partners <font style="Background-color:#FFFFFF;color:#000000;">Japan Tobacco, Inc. and its subsidiary Torii Pharmaceutical Co., Ltd., collectively, JT and Torii,</font> on December 12, 2018. The Company has not generated a profit to date and may never generate profits from product sales. The Company&#8217;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.</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">Management of the Company completed its going concern assessment in accordance with ASC 205-40. The Company believes that its cash resources will be sufficient to allow the Company to fund its current operating plans through at least the next twelve months from the filing of the Company&#8217;s Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2019, 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&#8217;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. </p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:12pt;">&nbsp;</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">The Company will require additional capital for the further commercialization of Auryxia and continued development and potential commercialization of the Company&#8217;s existing product candidates and would need to raise additional funds to pursue development activities related to any additional product candidates. If and until the Company can generate a sufficient amount of product revenue, the Company expects to finance future cash needs through public or private equity or debt offerings, payments from its collaborators, strategic transactions, or a combination of these approaches.</p> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:9pt;">&nbsp;</p>
CY2019Q1 us-gaap Use Of Estimates
UseOfEstimates
<p style="margin-bottom:0pt;margin-top:18pt;text-indent:0%;font-weight:bold;font-size:10pt;font-family:Times New Roman;font-style:normal;text-transform:none;font-variant: normal;">Use of Estimates </p> <p style="margin-top:6pt;margin-bottom:0pt;text-indent:0%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">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, 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. </p>
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0
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8000
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CY2019Q1 us-gaap Debt Securities Available For Sale Unrealized Loss Position Number Of Positions
DebtSecuritiesAvailableForSaleUnrealizedLossPositionNumberOfPositions
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CY2019Q1 us-gaap Lessee Operating Lease Existence Of Residual Value Guarantee
LesseeOperatingLeaseExistenceOfResidualValueGuarantee
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CY2019Q1 us-gaap Lessee Operating Lease Residual Value Guarantee Description
LesseeOperatingLeaseResidualValueGuaranteeDescription
The lease agreements do not contain residual value guarantees.
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FiniteLivedIntangibleAssetsNet
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FiniteLivedIntangibleAssetsAccumulatedAmortization
1522000
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FiniteLivedIntangibleAssetsNet
328153000
CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense Remainder Of Fiscal Year
FiniteLivedIntangibleAssetsAmortizationExpenseRemainderOfFiscalYear
27301000
CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense Year Two
FiniteLivedIntangibleAssetsAmortizationExpenseYearTwo
36402000
CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense Year Three
FiniteLivedIntangibleAssetsAmortizationExpenseYearThree
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CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense Year Four
FiniteLivedIntangibleAssetsAmortizationExpenseYearFour
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CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense Year Five
FiniteLivedIntangibleAssetsAmortizationExpenseYearFive
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CY2019Q1 us-gaap Finite Lived Intangible Assets Amortization Expense After Year Five
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CY2019Q1 us-gaap Business Combination Consideration Transferred1
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AccruedClinicalExpensesCurrent
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2430000
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CY2019Q1 us-gaap Postemployment Benefits Liability Current
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16930000
CY2018Q4 us-gaap Other Accrued Liabilities Current
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CY2019Q1 us-gaap Line Of Credit Facility Maximum Borrowing Capacity
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40000000
CY2019Q1 us-gaap Line Of Credit Facility Remaining Borrowing Capacity
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20800000
CY2018Q4 us-gaap Line Of Credit
LineOfCredit
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CY2019Q1 us-gaap Line Of Credit
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CY2019Q1 us-gaap Common Stock Capital Shares Reserved For Future Issuance
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CY2019Q1 us-gaap Allocated Share Based Compensation Expense
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CY2019Q1 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
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5192000
CY2019Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Two
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CY2019Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Five
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5347000
CY2019Q1 us-gaap Lessee Operating Lease Liability Payments Due After Year Five
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CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Five Years
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CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due Thereafter
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CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due
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CY2019Q1 us-gaap Lessee Operating Lease Liability Payments Due
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CY2019Q1 us-gaap Operating Lease Liability
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CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Two Years
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CY2019Q1 akba Purchase Committed Program Remaining Contract Costs
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CY2019Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
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CY2019Q1 akba Supply Agreement Description
SupplyAgreementDescription
The Esteve Supply Agreement has an initial term of four years, beginning April 9, 2019 and ending April 9, 2023. The Esteve Supply Agreement may be extended by mutual agreement of the Company and Esteve. The Esteve Supply Agreement allows the Company to terminate the relationship within one hundred and eighty (180) days’ written notice for any reason, or by either party in the event of a material breach. The Esteve Supply Agreement includes customary terms relating to, among others, indemnification, intellectual property protection, confidentiality, remedies, warranties, as well as certain quality requirements.

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