2019 Q4 Form 10-Q Financial Statement

#000156459019042962 Filed on November 12, 2019

View on sec.gov

Income Statement

Concept 2019 Q4 2019 Q3 2018 Q3
Revenue $69.60M $91.98M $53.17M
YoY Change 16.19% 72.99% 28.79%
Cost Of Revenue $38.15M $38.26M
YoY Change 391.08%
Gross Profit $39.50M $53.71M
YoY Change -26.17%
Gross Profit Margin 56.75% 58.4%
Selling, General & Admin $44.90M $34.18M $10.38M
YoY Change -18.51% 229.33% 54.9%
% of Gross Profit 113.67% 63.63%
Research & Development $80.40M $74.51M $70.63M
YoY Change -7.69% 5.49% 20.33%
% of Gross Profit 203.54% 138.72%
Depreciation & Amortization $9.690M $600.0K $200.0K
YoY Change 444.38% 200.0% 0.0%
% of Gross Profit 24.53% 1.12%
Operating Expenses $126.3M $109.6M $81.01M
YoY Change -11.21% 35.31% 23.76%
Operating Profit -$94.89M -$55.91M -$27.84M
YoY Change 5.25% 100.79% 15.17%
Interest Expense -$800.0K $228.0K $1.780M
YoY Change -147.06% -87.19% 111.4%
% of Operating Profit
Other Income/Expense, Net -$1.344M $43.00K $1.796M
YoY Change -176.1% -97.61% 72.36%
Pretax Income -$96.20M -$55.86M -$26.05M
YoY Change 8.82% 114.47% 12.76%
Income Tax -$1.752M -$1.277M $0.00
% Of Pretax Income
Net Earnings -$94.48M -$54.59M -$26.05M
YoY Change 57.33% 109.56% 12.59%
Net Earnings / Revenue -135.75% -59.35% -48.99%
Basic Earnings Per Share
Diluted Earnings Per Share -$791.5K -$459.2K -$456.1K
COMMON SHARES
Basic Shares Outstanding 118.9M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 Q3 2018 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $147.7M $145.6M $375.2M
YoY Change -54.05% -61.19% 22.19%
Cash & Equivalents $147.4M $122.9M $162.4M
Short-Term Investments $245.0K $22.73M $212.7M
Other Short-Term Assets $6.600M $7.800M $6.700M
YoY Change -57.96% 16.42% 67.5%
Inventory $116.3M $116.0M
Prepaid Expenses
Receivables $38.86M $29.65M $688.0K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $309.5M $299.0M $397.5M
YoY Change -33.9% -24.78% 19.05%
LONG-TERM ASSETS
Property, Plant & Equipment $10.38M $12.80M $3.800M
YoY Change 29.38% 236.82% 11.76%
Goodwill $55.10M $55.05M
YoY Change 0.09%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $75.99M $97.91M $2.500M
YoY Change -44.55% 3816.28% 92.31%
Total Long-Term Assets $461.7M $496.2M $6.300M
YoY Change -12.61% 7776.38% 34.04%
TOTAL ASSETS
Total Short-Term Assets $309.5M $299.0M $397.5M
Total Long-Term Assets $461.7M $496.2M $6.300M
Total Assets $771.2M $795.2M $403.8M
YoY Change -22.61% 96.93% 19.26%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $39.22M $64.36M $12.70M
YoY Change -8.36% 406.79% 45.98%
Accrued Expenses $129.1M $126.6M $94.60M
YoY Change -14.48% 33.87% 342.06%
Deferred Revenue $39.83M $32.14M $70.10M
YoY Change -30.1% -54.15%
Short-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0%
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $208.1M $223.1M $177.4M
YoY Change -21.67% 25.79% 17.17%
LONG-TERM LIABILITIES
Long-Term Debt $75.81M $0.00 $0.00
YoY Change
Other Long-Term Liabilities $30.22M $30.06M $83.90M
YoY Change 2.2% -64.17% -4.0%
Total Long-Term Liabilities $106.0M $30.06M $83.90M
YoY Change 258.53% -64.17% -4.0%
TOTAL LIABILITIES
Total Short-Term Liabilities $208.1M $223.1M $177.4M
Total Long-Term Liabilities $106.0M $30.06M $83.90M
Total Liabilities $376.4M $327.7M $261.3M
YoY Change 4.39% 25.4% 9.47%
SHAREHOLDERS EQUITY
Retained Earnings -$794.1M -$699.6M
YoY Change 54.37%
Common Stock $1.189B
YoY Change 3.32%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $394.8M $467.6M $142.5M
YoY Change
Total Liabilities & Shareholders Equity $771.2M $795.2M $403.8M
YoY Change -22.61% 96.93% 19.26%

Cashflow Statement

Concept 2019 Q4 2019 Q3 2018 Q3
OPERATING ACTIVITIES
Net Income -$94.48M -$54.59M -$26.05M
YoY Change 57.33% 109.56% 12.59%
Depreciation, Depletion And Amortization $9.690M $600.0K $200.0K
YoY Change 444.38% 200.0% 0.0%
Cash From Operating Activities -$92.13M $10.99M -$12.47M
YoY Change 25.02% -188.13% -77.17%
INVESTING ACTIVITIES
Capital Expenditures -$220.0K -$2.530M -$310.0K
YoY Change -73.49% 716.13% -47.46%
Acquisitions
YoY Change
Other Investing Activities $22.50M $26.92M $11.31M
YoY Change 28.21% 138.02% -125.5%
Cash From Investing Activities $22.28M $24.39M $11.01M
YoY Change 33.33% 121.53% -124.49%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 94.42M 190.0K 360.0K
YoY Change 117925.0% -47.22% -99.44%
NET CHANGE
Cash From Operating Activities -92.13M 10.99M -12.47M
Cash From Investing Activities 22.28M 24.39M 11.01M
Cash From Financing Activities 94.42M 190.0K 360.0K
Net Change In Cash 24.57M 35.57M -1.100M
YoY Change -143.18% -3333.64% -96.93%
FREE CASH FLOW
Cash From Operating Activities -$92.13M $10.99M -$12.47M
Capital Expenditures -$220.0K -$2.530M -$310.0K
Free Cash Flow -$91.91M $13.52M -$12.16M
YoY Change 26.15% -211.18% -77.49%

Facts In Submission

Frame Concept Type Concept / XBRL Key Value Unit
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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 people with kidney disease. Akebia&#8217;s commercial product, Auryxia<sup style="font-size:85%;line-height:120%;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%;line-height:120%;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%;line-height:120%;vertical-align:top">&#174;</sup><sup style="font-size:85%;line-height:120%;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%;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;">On November 11, 2019, the Company entered into a loan agreement, or the Loan Agreement, with Keryx as guarantor, Biopharma Credit plc as collateral agent and lender, or the Collateral Agent, and Biopharma Credit Investments V (Master) LP as lender, or collectively with the Collateral Agent, Pharmakon, pursuant to which term loans in an aggregate principal amount of $100.0 million are available to the Company in two tranches, subject to certain terms and conditions, or the Term Loan. Subject to the satisfaction of certain conditions, the first tranche of $80.0 million, or Tranche A, will be drawn in a single drawing on November 25, 2019, or the Tranche A Funding Date. The second&#160;tranche&#160;under the&#160;Term Loan&#160;allows the Company to borrow an additional $20.0 million until December 31, 2020, or Tranche B. Refer to Note 11 to our condensed consolidated financial statements in Part I, Item 1 &#8211; Financial Statements (unaudited) for additional details on the Loan Agreement.</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. </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. If the Company does not successfully commercialize any of its product candidates, it may be unable to achieve profitability.</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 expects its cash resources, including funds to be received from its collaborators and $100.0 million upon closing of the Term Loans with Pharmakon, subject to the satisfaction of certain customary conditions, to fund the Company&#8217;s current operating plan beyond the next twelve months, into the first quarter of 2021. However, on a quarterly basis, the Company is required to conduct an accounting analysis under ASC 205-40, <font style="font-style:italic;">Disclosure of Uncertainties about an Entity&#8217;s Ability to Continue as a Going Concern</font>, or ASC 205-40. Under the accounting standards, a company is not permitted to include elements of its operating plan that are deemed to be &#8220;outside of the company&#8217;s control&#8221; in an ASC 205-40 analysis, even though certain of those elements may be appropriately included in the company&#8217;s cash runway analysis.&#160; For example, the Company&#8217;s cash runway includes receipt of a milestone payment from Mitsubishi Tanabe Pharma Corporation, or MTPC, upon manufacturing and marketing approval of vadadustat in Japan, but since receipt of that milestone payment is deemed to be &#8220;outside of the Company&#8217;s control&#8221; under the accounting standards, the Company is not permitted to include it in its ASC 205-40 analysis. The result of the Company&#8217;s ASC 205-40 analysis is that there is &#8220;substantial doubt&#8221; that the Company will have sufficient funds to satisfy its obligations through the next twelve months from the date of issuance of this Quarterly Report on Form 10-Q. </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;">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 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 when needed or on attractive terms, it may be forced to delay, reduce or eliminate its research and development programs or any commercialization efforts.</p>
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1208000
CY2018Q4 us-gaap Accrued Salaries Current
AccruedSalariesCurrent
2255000
CY2019Q3 us-gaap Accrued Vacation Current
AccruedVacationCurrent
926000
CY2018Q4 us-gaap Accrued Vacation Current
AccruedVacationCurrent
1088000
CY2018Q4 us-gaap Postemployment Benefits Liability Current
PostemploymentBenefitsLiabilityCurrent
3962000
CY2018Q4 akba Accrued Merger Costs Current
AccruedMergerCostsCurrent
16071000
CY2019Q3 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
8763000
CY2018Q4 us-gaap Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
12082000
CY2019Q3 us-gaap Line Of Credit Facility Maximum Borrowing Capacity
LineOfCreditFacilityMaximumBorrowingCapacity
40000000
CY2019Q3 us-gaap Line Of Credit Facility Remaining Borrowing Capacity
LineOfCreditFacilityRemainingBorrowingCapacity
29400000
CY2018Q4 us-gaap Line Of Credit
LineOfCredit
15000000
CY2019Q3 us-gaap Line Of Credit
LineOfCredit
0
CY2019Q3 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
23528450
CY2018Q4 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
14948900
CY2019Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2613000
CY2018Q3 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
2252000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
6991000
us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
6978000
us-gaap Lessee Operating Lease Residual Value Guarantee Description
LesseeOperatingLeaseResidualValueGuaranteeDescription
The lease agreements do not contain residual value guarantees.
us-gaap Lessee Operating Lease Existence Of Residual Value Guarantee
LesseeOperatingLeaseExistenceOfResidualValueGuarantee
false
CY2019Q3 us-gaap Operating Lease Cost
OperatingLeaseCost
1700000
us-gaap Operating Lease Cost
OperatingLeaseCost
5000000
CY2019Q3 us-gaap Operating Lease Payments
OperatingLeasePayments
1700000
us-gaap Operating Lease Payments
OperatingLeasePayments
5200000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
1296000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
7008000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
7064000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
6735000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due Year Five
LesseeOperatingLeaseLiabilityPaymentsDueYearFive
5347000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due After Year Five
LesseeOperatingLeaseLiabilityPaymentsDueAfterYearFive
13934000
CY2019Q3 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
41384000
CY2019Q3 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
7689000
CY2019Q3 us-gaap Operating Lease Liability
OperatingLeaseLiability
33695000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due Current
OperatingLeasesFutureMinimumPaymentsDueCurrent
6777000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Two Years
OperatingLeasesFutureMinimumPaymentsDueInTwoYears
7008000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Three Years
OperatingLeasesFutureMinimumPaymentsDueInThreeYears
7064000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Four Years
OperatingLeasesFutureMinimumPaymentsDueInFourYears
6735000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due In Five Years
OperatingLeasesFutureMinimumPaymentsDueInFiveYears
5347000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due Thereafter
OperatingLeasesFutureMinimumPaymentsDueThereafter
13934000
CY2018Q4 us-gaap Operating Leases Future Minimum Payments Due
OperatingLeasesFutureMinimumPaymentsDue
46865000
CY2019Q3 akba Purchase Committed Program Remaining Contract Costs
PurchaseCommittedProgramRemainingContractCosts
76900000
us-gaap Research And Development Arrangement Contract To Perform For Others Costs Incurred Gross
ResearchAndDevelopmentArrangementContractToPerformForOthersCostsIncurredGross
52700000
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
13128410
us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
5361401

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