2021 Q1 Form 10-Q Financial Statement

#000162828021009696 Filed on May 10, 2021

View on sec.gov

Income Statement

Concept 2021 Q1 2020 Q1
Revenue $52.30M $88.48M
YoY Change -40.88% 21.76%
Cost Of Revenue $34.61M $27.71M
YoY Change 24.87% -11.34%
Gross Profit $17.70M $60.77M
YoY Change -70.87% 46.74%
Gross Profit Margin 33.84% 68.68%
Selling, General & Admin $41.33M $37.98M
YoY Change 8.81% 10.77%
% of Gross Profit 233.52% 62.51%
Research & Development $40.61M $81.23M
YoY Change -50.01% -1.36%
% of Gross Profit 229.47% 133.68%
Depreciation & Amortization $9.520M $525.0K
YoY Change 1713.33% 19.59%
% of Gross Profit 53.79% 0.86%
Operating Expenses $82.63M $119.9M
YoY Change -31.08% 2.14%
Operating Profit -$64.94M -$59.13M
YoY Change 9.83% -22.17%
Interest Expense -$4.805M -$1.972M
YoY Change 143.66% -326.93%
% of Operating Profit
Other Income/Expense, Net $161.0K -$1.622M
YoY Change -109.93% -305.06%
Pretax Income -$69.60M -$60.75M
YoY Change 14.57% -19.2%
Income Tax $0.00
% Of Pretax Income
Net Earnings -$69.58M -$60.75M
YoY Change 14.54% -16.12%
Net Earnings / Revenue -133.03% -68.66%
Basic Earnings Per Share -$0.45
Diluted Earnings Per Share -$0.45 -$472.7K
COMMON SHARES
Basic Shares Outstanding 153.8M shares 129.9M
Diluted Shares Outstanding 153.8M shares

Balance Sheet

Concept 2021 Q1 2020 Q1
SHORT-TERM ASSETS
Cash & Short-Term Investments $272.8M $115.4M
YoY Change 136.4% -31.33%
Cash & Equivalents $252.8M $115.4M
Short-Term Investments $20.00M $0.00
Other Short-Term Assets $12.20M $8.700M
YoY Change 40.23% -44.23%
Inventory $44.81M $111.9M
Prepaid Expenses
Receivables $35.23M $104.9M
Other Receivables $0.00 $0.00
Total Short-Term Assets $365.0M $340.8M
YoY Change 7.12% -1.86%
LONG-TERM ASSETS
Property, Plant & Equipment $8.168M $9.855M
YoY Change -17.12% -76.48%
Goodwill $55.10M $55.05M
YoY Change 0.09% 0.0%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $39.64M $71.92M
YoY Change -44.89% -43.85%
Total Long-Term Assets $263.7M $447.0M
YoY Change -41.0% -17.78%
TOTAL ASSETS
Total Short-Term Assets $365.0M $340.8M
Total Long-Term Assets $263.7M $447.0M
Total Assets $628.7M $787.7M
YoY Change -20.19% -11.57%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $30.54M $54.38M
YoY Change -43.84% 257.15%
Accrued Expenses $123.9M $124.9M
YoY Change -0.8% -9.37%
Deferred Revenue $18.25M $34.89M
YoY Change -47.68% -29.64%
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $172.7M $214.2M
YoY Change -19.37% 5.7%
LONG-TERM LIABILITIES
Long-Term Debt $96.61M $76.07M
YoY Change 26.99%
Other Long-Term Liabilities $53.62M $101.1M
YoY Change -46.97% -14.25%
Total Long-Term Liabilities $150.2M $76.07M
YoY Change 97.48% -35.48%
TOTAL LIABILITIES
Total Short-Term Liabilities $172.7M $214.2M
Total Long-Term Liabilities $150.2M $76.07M
Total Liabilities $414.8M $290.2M
YoY Change 42.93% -10.54%
SHAREHOLDERS EQUITY
Retained Earnings -$1.247B -$854.8M
YoY Change 45.89%
Common Stock $1.461B $1.251B
YoY Change 16.77%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $213.9M $396.4M
YoY Change
Total Liabilities & Shareholders Equity $628.7M $787.7M
YoY Change -20.19% -11.57%

Cashflow Statement

Concept 2021 Q1 2020 Q1
OPERATING ACTIVITIES
Net Income -$69.58M -$60.75M
YoY Change 14.54% -16.12%
Depreciation, Depletion And Amortization $9.520M $525.0K
YoY Change 1713.33% 19.59%
Cash From Operating Activities -$70.75M -$89.59M
YoY Change -21.03% -35.05%
INVESTING ACTIVITIES
Capital Expenditures $59.00K $0.00
YoY Change -100.0%
Acquisitions
YoY Change
Other Investing Activities $20.00M $250.0K
YoY Change 7900.0% -99.78%
Cash From Investing Activities $19.94M $245.0K
YoY Change 8039.18% -99.78%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities $74.48M $57.35M
YoY Change 29.87% -496.95%
NET CHANGE
Cash From Operating Activities -$70.75M -$89.59M
Cash From Investing Activities $19.94M $245.0K
Cash From Financing Activities $74.48M $57.35M
Net Change In Cash $23.67M -$32.00M
YoY Change -173.98% -23.64%
FREE CASH FLOW
Cash From Operating Activities -$70.75M -$89.59M
Capital Expenditures $59.00K $0.00
Free Cash Flow -$70.81M -$89.59M
YoY Change -20.97% -35.94%

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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 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</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">TM</span><span style="color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:120%">. The Company submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for vadadustat in March of 2021 for the treatment of anemia due to CKD in adult patients with CKD on dialysis, or DD-CKD, and adult patients with CKD not on dialysis, or NDD-CKD. The Company's NDA submission did not include a Priority Review Voucher. Based on standard FDA review timelines, the FDA has a 60-day period to determine whether the NDA is complete and acceptable for review. 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 FDA and marketed for two indications in the United States: the control of serum phosphorus levels in DD-CKD adult patients and the treatment of iron deficiency anemia, or IDA, in NDD-CKD adult patients. Ferric citrate is also approved and marketed in Japan as an oral treatment for IDA in adult patients and the improvement of hyperphosphatemia in adult 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: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 in August 2020. In February 2021, the Company entered into a royalty interest acquisition agreement with HealthCare Royalty Partners IV, L.P., or the Royalty Agreement, whereby the Company sold its right to receive royalties and sales milestones under its Collaboration Agreement with MTPC, or the MTPC Agreement, subject to certain caps and other terms and conditions (see Note 5 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 or any other potential product candidate, 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 through at least 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 Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired. The Company expects to finance future cash needs through product revenue, public or private equity or debt transactions, payments from its collaborators, 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 Auryxia and vadadustat or any additional products and product candidates, including those that may be in-licensed or acquired.</span></div>
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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, including the excess purchase commitment liability, stock-based compensation expense, product and collaboration revenues including various rebates and reserves related to product sales, non-cash interest expense on the liability related to sale of future royalties, 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. </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. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances.</span></div>
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CY2021Q1 us-gaap Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
0.00001
CY2020Q4 us-gaap Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
0 shares
CY2021Q1 us-gaap Preferred Stock Shares Issued
PreferredStockSharesIssued
0 shares
CY2021Q1 us-gaap Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
0 shares
CY2020Q4 us-gaap Preferred Stock Shares Issued
PreferredStockSharesIssued
0 shares
CY2021Q1 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
27437323 shares
CY2020Q4 us-gaap Common Stock Capital Shares Reserved For Future Issuance
CommonStockCapitalSharesReservedForFutureIssuance
23566853 shares
CY2021Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5992000 USD
CY2020Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4916000 USD
CY2021Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
5992000 USD
CY2020Q1 us-gaap Allocated Share Based Compensation Expense
AllocatedShareBasedCompensationExpense
4916000 USD
CY2021Q1 us-gaap Operating Lease Cost
OperatingLeaseCost
1700000 USD
CY2020Q1 us-gaap Operating Lease Cost
OperatingLeaseCost
1700000 USD
CY2021Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
1800000 USD
CY2020Q1 us-gaap Operating Lease Payments
OperatingLeasePayments
1700000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
4896000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received Remainder Of Fiscal Year
LessorOperatingLeasePaymentsToBeReceivedRemainderOfFiscalYear
1349000 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Net Reminder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsNetReminderOfFiscalYear
3547000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
7322000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received Next Twelve Months
LessorOperatingLeasePaymentsToBeReceivedNextTwelveMonths
1824000 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net Year One
LesseeOperatingLeaseLiabilityPaymentsDueNetYearOne
5498000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
5947000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received Two Years
LessorOperatingLeasePaymentsToBeReceivedTwoYears
307000 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net Year Two
LesseeOperatingLeaseLiabilityPaymentsDueNetYearTwo
5640000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
5739000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received Three Years
LessorOperatingLeasePaymentsToBeReceivedThreeYears
0 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net Year Three
LesseeOperatingLeaseLiabilityPaymentsDueNetYearThree
5739000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
5817000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received Four Years
LessorOperatingLeasePaymentsToBeReceivedFourYears
0 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net Year Four
LesseeOperatingLeaseLiabilityPaymentsDueNetYearFour
5817000 USD
CY2021Q1 akba Lessee Operating Lease Liability To Be Paid Due After Year Four
LesseeOperatingLeaseLiabilityToBePaidDueAfterYearFour
4104000 USD
CY2021Q1 akba Lessor Operating Lease Payment To Be Received Due After Year Four
LessorOperatingLeasePaymentToBeReceivedDueAfterYearFour
0 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net After Year Four
LesseeOperatingLeaseLiabilityPaymentsDueNetAfterYearFour
4104000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
33825000 USD
CY2021Q1 us-gaap Lessor Operating Lease Payments To Be Received
LessorOperatingLeasePaymentsToBeReceived
3480000 USD
CY2021Q1 akba Lessee Operating Lease Liability Payments Due Net
LesseeOperatingLeaseLiabilityPaymentsDueNet
30345000 USD
CY2021Q1 us-gaap Research And Development Arrangement Contract To Perform For Others Costs Incurred Gross
ResearchAndDevelopmentArrangementContractToPerformForOthersCostsIncurredGross
192300000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
33825000 USD
CY2021Q1 us-gaap Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
5179000 USD
CY2021Q1 us-gaap Operating Lease Liability
OperatingLeaseLiability
28646000 USD
CY2021Q1 akba Purchase Committed Program Remaining Contract Costs
PurchaseCommittedProgramRemainingContractCosts
8300000 USD
CY2021Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
18402397 shares
CY2020Q1 us-gaap Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
16617256 shares

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