2023 Q2 Form 10-Q Financial Statement
#000162828023016258 Filed on May 08, 2023
Income Statement
Concept | 2023 Q2 | 2023 Q1 |
---|---|---|
Revenue | $56.38M | $40.13M |
YoY Change | -55.53% | -34.96% |
Cost Of Revenue | $17.28M | $19.48M |
YoY Change | -7.08% | -37.84% |
Gross Profit | $39.09M | $20.64M |
YoY Change | -63.86% | -31.99% |
Gross Profit Margin | 69.34% | 51.44% |
Selling, General & Admin | $27.04M | $25.22M |
YoY Change | -17.59% | -43.1% |
% of Gross Profit | 69.16% | 122.18% |
Research & Development | $20.20M | $19.69M |
YoY Change | -22.4% | -55.09% |
% of Gross Profit | 51.67% | 95.36% |
Depreciation & Amortization | $9.011M | $9.409M |
YoY Change | -4.4% | -0.2% |
% of Gross Profit | 23.05% | 45.58% |
Operating Expenses | $48.09M | $45.58M |
YoY Change | -35.24% | -48.7% |
Operating Profit | -$8.996M | -$24.94M |
YoY Change | -126.54% | -57.37% |
Interest Expense | -$1.642M | -$1.561M |
YoY Change | -67.4% | -69.16% |
% of Operating Profit | ||
Other Income/Expense, Net | -$10.00K | $282.0K |
YoY Change | -102.43% | -75.13% |
Pretax Income | -$11.17M | -$26.22M |
YoY Change | -138.16% | -58.0% |
Income Tax | ||
% Of Pretax Income | ||
Net Earnings | -$11.17M | -$26.22M |
YoY Change | -138.16% | -58.0% |
Net Earnings / Revenue | -19.82% | -65.34% |
Basic Earnings Per Share | -$0.06 | -$0.14 |
Diluted Earnings Per Share | -$0.06 | -$0.14 |
COMMON SHARES | ||
Basic Shares Outstanding | 185.9M shares | 184.2M shares |
Diluted Shares Outstanding | 186.8M shares | 184.8M shares |
Balance Sheet
Concept | 2023 Q2 | 2023 Q1 |
---|---|---|
SHORT-TERM ASSETS | ||
Cash & Short-Term Investments | $53.57M | $56.95M |
YoY Change | -62.77% | -67.37% |
Cash & Equivalents | $53.57M | $57.00M |
Short-Term Investments | ||
Other Short-Term Assets | $24.40M | $25.38M |
YoY Change | -42.09% | 5.22% |
Inventory | $20.91M | $20.60M |
Prepaid Expenses | $15.60M | |
Receivables | $19.57M | $17.78M |
Other Receivables | $0.00 | $0.00 |
Total Short-Term Assets | $118.4M | $120.7M |
YoY Change | -61.06% | -60.12% |
LONG-TERM ASSETS | ||
Property, Plant & Equipment | $4.419M | $4.816M |
YoY Change | -26.78% | -25.34% |
Goodwill | $59.00M | $55.10M |
YoY Change | 7.08% | 0.0% |
Intangibles | $54.06M | |
YoY Change | ||
Long-Term Investments | ||
YoY Change | ||
Other Assets | $3.348M | $5.238M |
YoY Change | -90.42% | -86.71% |
Total Long-Term Assets | $135.3M | $156.1M |
YoY Change | -37.85% | -32.89% |
TOTAL ASSETS | ||
Total Short-Term Assets | $118.4M | $120.7M |
Total Long-Term Assets | $135.3M | $156.1M |
Total Assets | $253.7M | $276.9M |
YoY Change | -51.38% | -48.29% |
SHORT-TERM LIABILITIES | ||
YoY Change | ||
Accounts Payable | $11.78M | $12.58M |
YoY Change | -52.79% | -35.39% |
Accrued Expenses | $56.41M | $46.37M |
YoY Change | -38.21% | -57.72% |
Deferred Revenue | $0.00 | $0.00 |
YoY Change | -100.0% | -100.0% |
Short-Term Debt | $0.00 | $0.00 |
YoY Change | ||
Long-Term Debt Due | $24.00M | $24.00M |
YoY Change | -75.55% | -75.47% |
Total Short-Term Liabilities | $92.18M | $82.94M |
YoY Change | -60.55% | -67.33% |
LONG-TERM LIABILITIES | ||
Long-Term Debt | $18.49M | $26.30M |
YoY Change | ||
Other Long-Term Liabilities | $17.14M | $12.64M |
YoY Change | -74.37% | -83.74% |
Total Long-Term Liabilities | $35.63M | $38.94M |
YoY Change | -46.74% | -49.91% |
TOTAL LIABILITIES | ||
Total Short-Term Liabilities | $92.18M | $82.94M |
Total Long-Term Liabilities | $35.63M | $38.94M |
Total Liabilities | $280.5M | $291.2M |
YoY Change | -38.95% | -42.81% |
SHAREHOLDERS EQUITY | ||
Retained Earnings | -$1.595B | -$1.579B |
YoY Change | 6.8% | 3.7% |
Common Stock | $1.568B | $1.565B |
YoY Change | 0.8% | 1.03% |
Preferred Stock | ||
YoY Change | ||
Treasury Stock (at cost) | ||
YoY Change | ||
Treasury Stock Shares | ||
Shareholders Equity | -$26.81M | -$14.35M |
YoY Change | ||
Total Liabilities & Shareholders Equity | $253.7M | $276.9M |
YoY Change | -51.38% | -48.29% |
Cashflow Statement
Concept | 2023 Q2 | 2023 Q1 |
---|---|---|
OPERATING ACTIVITIES | ||
Net Income | -$11.17M | -$26.22M |
YoY Change | -138.16% | -58.0% |
Depreciation, Depletion And Amortization | $9.011M | $9.409M |
YoY Change | -4.4% | -0.2% |
Cash From Operating Activities | $3.629M | -$17.54M |
YoY Change | -111.84% | -18.88% |
INVESTING ACTIVITIES | ||
Capital Expenditures | $0.00 | $0.00 |
YoY Change | -100.0% | |
Acquisitions | ||
YoY Change | ||
Other Investing Activities | ||
YoY Change | ||
Cash From Investing Activities | $0.00 | $0.00 |
YoY Change | -100.0% | |
FINANCING ACTIVITIES | ||
Cash Dividend Paid | ||
YoY Change | ||
Common Stock Issuance & Retirement, Net | ||
YoY Change | ||
Debt Paid & Issued, Net | ||
YoY Change | ||
Cash From Financing Activities | -8.000M | -$15.97M |
YoY Change | 88788.89% | -133.58% |
NET CHANGE | ||
Cash From Operating Activities | 3.629M | -$17.54M |
Cash From Investing Activities | 0.000 | $0.00 |
Cash From Financing Activities | -8.000M | -$15.97M |
Net Change In Cash | -4.371M | -$33.50M |
YoY Change | -85.75% | -229.81% |
FREE CASH FLOW | ||
Cash From Operating Activities | $3.629M | -$17.54M |
Capital Expenditures | $0.00 | $0.00 |
Free Cash Flow | $3.629M | -$17.54M |
YoY Change | -111.84% | -19.31% |
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CY2023Q1 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.14 | |
CY2023Q1 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-0.14 | |
CY2022Q1 | us-gaap |
Earnings Per Share Basic
EarningsPerShareBasic
|
-0.35 | |
CY2022Q1 | us-gaap |
Earnings Per Share Diluted
EarningsPerShareDiluted
|
-0.35 | |
CY2023Q1 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
184768983 | shares |
CY2023Q1 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
184768983 | shares |
CY2022Q1 | us-gaap |
Weighted Average Number Of Shares Outstanding Basic
WeightedAverageNumberOfSharesOutstandingBasic
|
179599045 | shares |
CY2022Q1 | us-gaap |
Weighted Average Number Of Diluted Shares Outstanding
WeightedAverageNumberOfDilutedSharesOutstanding
|
179599045 | shares |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-26217000 | usd |
CY2022Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-62421000 | usd |
CY2023Q1 | us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-26217000 | usd |
CY2022Q1 | us-gaap |
Comprehensive Income Net Of Tax
ComprehensiveIncomeNetOfTax
|
-62421000 | usd |
CY2023Q1 | us-gaap |
Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
|
0.00001 | |
CY2021Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
76456000 | usd |
CY2022Q1 | us-gaap |
Stock Issued During Period Value New Issues
StockIssuedDuringPeriodValueNewIssues
|
7178000 | usd |
CY2022Q1 | akba |
Stock Issued During Period Value Including Offering Costs Employee Stock Purchase Plan
StockIssuedDuringPeriodValueIncludingOfferingCostsEmployeeStockPurchasePlan
|
367000 | usd |
CY2022Q1 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
4536000 | usd |
CY2022Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-62421000 | usd |
CY2022Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
26116000 | usd |
CY2022Q4 | us-gaap |
Stockholders Equity
StockholdersEquity
|
9342000 | usd |
CY2023Q1 | akba |
Stock Issued During Period Value Including Offering Costs Employee Stock Purchase Plan
StockIssuedDuringPeriodValueIncludingOfferingCostsEmployeeStockPurchasePlan
|
34000 | usd |
CY2023Q1 | us-gaap |
Adjustments To Additional Paid In Capital Sharebased Compensation Requisite Service Period Recognition Value
AdjustmentsToAdditionalPaidInCapitalSharebasedCompensationRequisiteServicePeriodRecognitionValue
|
2489000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-26217000 | usd |
CY2023Q1 | us-gaap |
Stockholders Equity
StockholdersEquity
|
-14352000 | usd |
CY2023Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-26217000 | usd |
CY2022Q1 | us-gaap |
Inventory Write Down
InventoryWriteDown
|
5344000 | usd |
CY2022Q1 | us-gaap |
Net Income Loss
NetIncomeLoss
|
-62421000 | usd |
CY2023Q1 | us-gaap |
Other Depreciation And Amortization
OtherDepreciationAndAmortization
|
398000 | usd |
CY2022Q1 | us-gaap |
Other Depreciation And Amortization
OtherDepreciationAndAmortization
|
417000 | usd |
CY2023Q1 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
9011000 | usd |
CY2022Q1 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
9011000 | usd |
CY2023Q1 | akba |
Contractual Arrangement Royalties Agreement Noncash Interest Expense Income
ContractualArrangementRoyaltiesAgreementNoncashInterestExpenseIncome
|
0 | usd |
CY2022Q1 | akba |
Contractual Arrangement Royalties Agreement Noncash Interest Expense Income
ContractualArrangementRoyaltiesAgreementNoncashInterestExpenseIncome
|
2345000 | usd |
CY2023Q1 | akba |
Contractual Arrangement Royalties Agreement Noncash Royalty Revenue
ContractualArrangementRoyaltiesAgreementNoncashRoyaltyRevenue
|
425000 | usd |
CY2022Q1 | akba |
Contractual Arrangement Royalties Agreement Noncash Royalty Revenue
ContractualArrangementRoyaltiesAgreementNoncashRoyaltyRevenue
|
329000 | usd |
CY2023Q1 | akba |
Noncash Research And Development Expense
NoncashResearchAndDevelopmentExpense
|
782000 | usd |
CY2022Q1 | akba |
Noncash Research And Development Expense
NoncashResearchAndDevelopmentExpense
|
0 | usd |
CY2023Q1 | akba |
Noncash Interest Expense
NoncashInterestExpense
|
502000 | usd |
CY2022Q1 | akba |
Noncash Interest Expense
NoncashInterestExpense
|
246000 | usd |
CY2023Q1 | us-gaap |
Straight Line Rent
StraightLineRent
|
578000 | usd |
CY2022Q1 | us-gaap |
Straight Line Rent
StraightLineRent
|
557000 | usd |
CY2023Q1 | us-gaap |
Inventory Write Down
InventoryWriteDown
|
335000 | usd |
CY2023Q1 | us-gaap |
Cash And Cash Equivalents At Carrying Value
CashAndCashEquivalentsAtCarryingValue
|
57000000 | usd |
CY2023Q1 | akba |
Excess Inventory Purchase Commitments Expense Reversal
ExcessInventoryPurchaseCommitmentsExpenseReversal
|
0 | usd |
CY2022Q1 | akba |
Excess Inventory Purchase Commitments Expense Reversal
ExcessInventoryPurchaseCommitmentsExpenseReversal
|
-773000 | usd |
CY2023Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
2489000 | usd |
CY2022Q1 | us-gaap |
Share Based Compensation
ShareBasedCompensation
|
4536000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Derivative Liabilities
IncreaseDecreaseInDerivativeLiabilities
|
0 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Derivative Liabilities
IncreaseDecreaseInDerivativeLiabilities
|
-710000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
-21399000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Accounts Receivable
IncreaseDecreaseInAccountsReceivable
|
13707000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
-7347000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Inventories
IncreaseDecreaseInInventories
|
5247000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-7378000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Prepaid Deferred Expense And Other Assets
IncreaseDecreaseInPrepaidDeferredExpenseAndOtherAssets
|
-9019000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Other Noncurrent Assets
IncreaseDecreaseInOtherNoncurrentAssets
|
2812000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Other Noncurrent Assets
IncreaseDecreaseInOtherNoncurrentAssets
|
-3297000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
-9013000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Accounts Payable
IncreaseDecreaseInAccountsPayable
|
-7358000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
|
-25047000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Accrued Liabilities
IncreaseDecreaseInAccruedLiabilities
|
4426000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Operating Lease Liability
IncreaseDecreaseInOperatingLeaseLiability
|
651000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Operating Lease Liability
IncreaseDecreaseInOperatingLeaseLiability
|
616000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
-3738000 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Contract With Customer Liability
IncreaseDecreaseInContractWithCustomerLiability
|
33416000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Other Noncurrent Liabilities
IncreaseDecreaseInOtherNoncurrentLiabilities
|
0 | usd |
CY2022Q1 | us-gaap |
Increase Decrease In Other Noncurrent Liabilities
IncreaseDecreaseInOtherNoncurrentLiabilities
|
-3191000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-17538000 | usd |
CY2022Q1 | us-gaap |
Net Cash Provided By Used In Operating Activities
NetCashProvidedByUsedInOperatingActivities
|
-21620000 | usd |
CY2023Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
0 | usd |
CY2022Q1 | us-gaap |
Payments To Acquire Property Plant And Equipment
PaymentsToAcquirePropertyPlantAndEquipment
|
114000 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
0 | usd |
CY2022Q1 | us-gaap |
Net Cash Provided By Used In Investing Activities
NetCashProvidedByUsedInInvestingActivities
|
-114000 | usd |
CY2023Q1 | akba |
Proceeds From Refund Liability To Contract With Customer
ProceedsFromRefundLiabilityToContractWithCustomer
|
0 | usd |
CY2022Q1 | akba |
Proceeds From Refund Liability To Contract With Customer
ProceedsFromRefundLiabilityToContractWithCustomer
|
40000000 | usd |
CY2023Q1 | akba |
Proceeds From Issuance Of Common Stock Net Of Issuance Costs
ProceedsFromIssuanceOfCommonStockNetOfIssuanceCosts
|
0 | usd |
CY2022Q1 | akba |
Proceeds From Issuance Of Common Stock Net Of Issuance Costs
ProceedsFromIssuanceOfCommonStockNetOfIssuanceCosts
|
7178000 | usd |
CY2023Q1 | us-gaap |
Proceeds From Stock Plans
ProceedsFromStockPlans
|
34000 | usd |
CY2022Q1 | us-gaap |
Proceeds From Stock Plans
ProceedsFromStockPlans
|
367000 | usd |
CY2023Q1 | us-gaap |
Repayments Of Debt
RepaymentsOfDebt
|
16000000 | usd |
CY2022Q1 | us-gaap |
Repayments Of Debt
RepaymentsOfDebt
|
0 | usd |
CY2023Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
-15966000 | usd |
CY2022Q1 | us-gaap |
Net Cash Provided By Used In Financing Activities
NetCashProvidedByUsedInFinancingActivities
|
47545000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
-33504000 | usd |
CY2022Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents Period Increase Decrease Including Exchange Rate Effect
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalentsPeriodIncreaseDecreaseIncludingExchangeRateEffect
|
25811000 | usd |
CY2022Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
93169000 | usd |
CY2021Q4 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
151839000 | usd |
CY2023Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
59665000 | usd |
CY2022Q1 | us-gaap |
Cash Cash Equivalents Restricted Cash And Restricted Cash Equivalents
CashCashEquivalentsRestrictedCashAndRestrictedCashEquivalents
|
177650000 | usd |
CY2023Q1 | us-gaap |
Nature Of Operations
NatureOfOperations
|
Nature of Organization and Operations<div style="margin-top:6pt"><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, or FDA, and marketed for two indications in the United States: 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. 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, or HIF-PH, inhibitor designed to mimic the physiologic effect of altitude on oxygen availability. On March 29, 2022, the Company received a complete response letter, or CRL, from the FDA. The CRL provided that the FDA had completed its review of the Company's new drug application, or NDA, 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, or FDRR, with the FDA. The FDRR 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 February 2023, the Company received a second interim response from the FDA to the FDRR. In March 2023, the Company had a productive meeting with the FDA, who indicated that it was continuing internal consultation with experts to complete the review and render a decision. FDA has indicated that it has completed internal discussions, and the Company expects a response to the FDRR within the next thirty days. In October 2021, the Company's former collaboration partner, Otsuka Pharmaceutical Co. Ltd., or Otsuka, submitted a Marketing Authorization Application, or MAA, for vadadustat for the treatment of anemia due to CKD in adult patients with DD-CKD and NDD-CKD to the European Medicines Agency, or EMA</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, or the Termination Agreement, Otsuka transferred the MAA for vadadustat with the EMA to the Company. In April 2023, the European Commission, or EC, 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. 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">TM</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:#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, or MTPC. 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 JT and Torii, 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., or HCR, 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, if approved, or any other potential product candidate, it may be unable to achieve profitability.</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%">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 March 31, 2023, the Company had cash and cash equivalents of approximately $57.0 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 </span></div><span style="background-color:#ffffff;color:#000000;font-family:'Times New Roman',sans-serif;font-size:10pt;font-weight:400;line-height:112%">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 could 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> | |
CY2023Q1 | akba |
Number Of Commercial Products
NumberOfCommercialProducts
|
1 | commercial_product |
CY2023Q1 | us-gaap |
Number Of Operating Segments
NumberOfOperatingSegments
|
1 | segment |
CY2023Q1 | us-gaap |
Use Of Estimates
UseOfEstimates
|
<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 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, refund liabilities to customers, other non-current liabilities, 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. </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> | |
CY2022Q4 | us-gaap |
Valuation Allowances And Reserves Balance
ValuationAllowancesAndReservesBalance
|
31353000 | usd |
CY2023Q1 | us-gaap |
Valuation Allowances And Reserves Charged To Cost And Expense
ValuationAllowancesAndReservesChargedToCostAndExpense
|
20151000 | usd |
CY2023Q1 | akba |
Valuation Allowances And Reserves Adjustments Related To Prior Period Sales
ValuationAllowancesAndReservesAdjustmentsRelatedToPriorPeriodSales
|
-1748000 | usd |
CY2023Q1 | us-gaap |
Valuation Allowances And Reserves Deductions
ValuationAllowancesAndReservesDeductions
|
25949000 | usd |
CY2023Q1 | us-gaap |
Valuation Allowances And Reserves Balance
ValuationAllowancesAndReservesBalance
|
23807000 | usd |
CY2021Q4 | us-gaap |
Valuation Allowances And Reserves Balance
ValuationAllowancesAndReservesBalance
|
28378000 | usd |
CY2022Q1 | us-gaap |
Valuation Allowances And Reserves Charged To Cost And Expense
ValuationAllowancesAndReservesChargedToCostAndExpense
|
25394000 | usd |
CY2022Q1 | akba |
Valuation Allowances And Reserves Adjustments Related To Prior Period Sales
ValuationAllowancesAndReservesAdjustmentsRelatedToPriorPeriodSales
|
647000 | usd |
CY2022Q1 | us-gaap |
Valuation Allowances And Reserves Deductions
ValuationAllowancesAndReservesDeductions
|
26249000 | usd |
CY2022Q1 | us-gaap |
Valuation Allowances And Reserves Balance
ValuationAllowancesAndReservesBalance
|
28170000 | usd |
CY2023Q1 | us-gaap |
Contract With Customer Liability Current
ContractWithCustomerLiabilityCurrent
|
0 | usd |
CY2023Q1 | us-gaap |
Contract With Customer Liability Noncurrent
ContractWithCustomerLiabilityNoncurrent
|
43296000 | usd |
CY2023Q1 | us-gaap |
Contract With Customer Liability
ContractWithCustomerLiability
|
43296000 | usd |
CY2023Q1 | us-gaap |
Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
|
3738000 | usd |
CY2022Q1 | us-gaap |
Contract With Customer Liability Revenue Recognized
ContractWithCustomerLiabilityRevenueRecognized
|
6602000 | usd |
CY2023Q1 | us-gaap |
Contract With Customer Performance Obligation Satisfied In Previous Period
ContractWithCustomerPerformanceObligationSatisfiedInPreviousPeriod
|
0 | usd |
CY2022Q1 | us-gaap |
Contract With Customer Performance Obligation Satisfied In Previous Period
ContractWithCustomerPerformanceObligationSatisfiedInPreviousPeriod
|
0 | usd |
CY2023Q1 | akba |
Contract With Customer Refund Liability Amortization Of Discount
ContractWithCustomerRefundLiabilityAmortizationOfDiscount
|
800000 | usd |
CY2022Q1 | akba |
Contract With Customer Refund Liability Amortization Of Discount
ContractWithCustomerRefundLiabilityAmortizationOfDiscount
|
0 | usd |
CY2023Q1 | akba |
Contract With Customer Refund Liability Amortization Of Deferred Gain
ContractWithCustomerRefundLiabilityAmortizationOfDeferredGain
|
1000000 | usd |
CY2022Q1 | akba |
Contract With Customer Refund Liability Amortization Of Deferred Gain
ContractWithCustomerRefundLiabilityAmortizationOfDeferredGain
|
0 | usd |
CY2021Q1 | akba |
Contractual Arrangement Royalties Agreement Maximum Annual Royalty Payout Capacity
ContractualArrangementRoyaltiesAgreementMaximumAnnualRoyaltyPayoutCapacity
|
13000000 | usd |
CY2021Q1 | akba |
Contractual Arrangement Royalties Agreement Maximum Aggregate Royalty Payout Capacity
ContractualArrangementRoyaltiesAgreementMaximumAggregateRoyaltyPayoutCapacity
|
150000000 | usd |
CY2021Q1 | akba |
Proceeds From Contractual Arrangement Royalties Agreement Sale Of Future Royalties
ProceedsFromContractualArrangementRoyaltiesAgreementSaleOfFutureRoyalties
|
44800000 | usd |
CY2021Q1 | akba |
Contractual Arrangement Royalties Agreement Liability Noncurrent
ContractualArrangementRoyaltiesAgreementLiabilityNoncurrent
|
44800000 | usd |
CY2023Q1 | akba |
Contractual Arrangement Royalties Agreement Interest Rate Effective Percentage
ContractualArrangementRoyaltiesAgreementInterestRateEffectivePercentage
|
0 | |
CY2022Q4 | akba |
Contractual Arrangement Royalties Agreement Liability Noncurrent
ContractualArrangementRoyaltiesAgreementLiabilityNoncurrent
|
57484000 | usd |
CY2023Q1 | akba |
Contractual Arrangement Royalties Agreement Royalties Earned And Payable
ContractualArrangementRoyaltiesAgreementRoyaltiesEarnedAndPayable
|
425000 | usd |
CY2023Q1 | akba |
Contractual Arrangement Royalties Agreement Liability Noncurrent
ContractualArrangementRoyaltiesAgreementLiabilityNoncurrent
|
57059000 | usd |
CY2022Q4 | us-gaap |
Derivative Fair Value Of Derivative Liability
DerivativeFairValueOfDerivativeLiability
|
760000 | usd |
CY2023Q1 | us-gaap |
Increase Decrease In Derivative Liabilities
IncreaseDecreaseInDerivativeLiabilities
|
0 | usd |
CY2023Q1 | us-gaap |
Derivative Fair Value Of Derivative Liability
DerivativeFairValueOfDerivativeLiability
|
760000 | usd |
CY2023Q1 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
503000 | usd |
CY2022Q4 | us-gaap |
Inventory Raw Materials Net Of Reserves
InventoryRawMaterialsNetOfReserves
|
610000 | usd |
CY2023Q1 | us-gaap |
Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
|
8100000 | usd |
CY2022Q4 | us-gaap |
Inventory Work In Process Net Of Reserves
InventoryWorkInProcessNetOfReserves
|
8086000 | usd |
CY2023Q1 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
12504000 | usd |
CY2022Q4 | us-gaap |
Inventory Finished Goods Net Of Reserves
InventoryFinishedGoodsNetOfReserves
|
13676000 | usd |
CY2023Q1 | akba |
Inventory Net Current And Non Current
InventoryNetCurrentAndNonCurrent
|
21107000 | usd |
CY2022Q4 | akba |
Inventory Net Current And Non Current
InventoryNetCurrentAndNonCurrent
|
22372000 | usd |
CY2023Q1 | us-gaap |
Inventory Net
InventoryNet
|
20604000 | usd |
CY2022Q4 | us-gaap |
Inventory Net
InventoryNet
|
21762000 | usd |
CY2023Q1 | us-gaap |
Inventory Noncurrent
InventoryNoncurrent
|
503000 | usd |
CY2022Q4 | us-gaap |
Inventory Noncurrent
InventoryNoncurrent
|
610000 | usd |
CY2023Q1 | akba |
Inventory Net Current And Non Current
InventoryNetCurrentAndNonCurrent
|
21107000 | usd |
CY2022Q4 | akba |
Inventory Net Current And Non Current
InventoryNetCurrentAndNonCurrent
|
22372000 | usd |
CY2023Q1 | us-gaap |
Inventory Write Down
InventoryWriteDown
|
300000 | usd |
CY2022Q1 | us-gaap |
Inventory Write Down
InventoryWriteDown
|
5300000 | usd |
CY2023Q1 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2023Q1 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
213603000 | usd |
CY2023Q1 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
150529000 | usd |
CY2023Q1 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
63074000 | usd |
CY2022Q4 | us-gaap |
Finite Lived Intangible Assets Gross
FiniteLivedIntangibleAssetsGross
|
213603000 | usd |
CY2022Q4 | us-gaap |
Finite Lived Intangible Assets Accumulated Amortization
FiniteLivedIntangibleAssetsAccumulatedAmortization
|
141519000 | usd |
CY2022Q4 | us-gaap |
Finite Lived Intangible Assets Net
FiniteLivedIntangibleAssetsNet
|
72084000 | usd |
CY2022Q1 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
9000000 | usd |
CY2023Q1 | us-gaap |
Amortization Of Intangible Assets
AmortizationOfIntangibleAssets
|
9000000 | usd |
CY2022Q4 | us-gaap |
Goodwill
Goodwill
|
55100000 | usd |
CY2023Q1 | us-gaap |
Goodwill
Goodwill
|
55100000 | usd |
CY2023Q1 | us-gaap |
Number Of Operating Segments
NumberOfOperatingSegments
|
1 | segment |
CY2023Q1 | akba |
Accrued Product Revenue Allowances Current
AccruedProductRevenueAllowancesCurrent
|
22368000 | usd |
CY2022Q4 | akba |
Accrued Product Revenue Allowances Current
AccruedProductRevenueAllowancesCurrent
|
29005000 | usd |
CY2023Q1 | akba |
Accrued Clinical Expenses Current
AccruedClinicalExpensesCurrent
|
1148000 | usd |
CY2022Q4 | akba |
Accrued Clinical Expenses Current
AccruedClinicalExpensesCurrent
|
5755000 | usd |
CY2023Q1 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
5717000 | usd |
CY2022Q4 | us-gaap |
Employee Related Liabilities Current
EmployeeRelatedLiabilitiesCurrent
|
11481000 | usd |
CY2023Q1 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
5160000 | usd |
CY2022Q4 | us-gaap |
Operating Lease Liability Current
OperatingLeaseLiabilityCurrent
|
4744000 | usd |
CY2023Q1 | us-gaap |
Accrued Royalties Current
AccruedRoyaltiesCurrent
|
2636000 | usd |
CY2022Q4 | us-gaap |
Accrued Royalties Current
AccruedRoyaltiesCurrent
|
3804000 | usd |
CY2023Q1 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
1621000 | usd |
CY2022Q4 | us-gaap |
Accrued Professional Fees Current
AccruedProfessionalFeesCurrent
|
1734000 | usd |
CY2023Q1 | akba |
Accrued Commercial Manufacturing Current
AccruedCommercialManufacturingCurrent
|
1299000 | usd |
CY2022Q4 | akba |
Accrued Commercial Manufacturing Current
AccruedCommercialManufacturingCurrent
|
4310000 | usd |
CY2023Q1 | us-gaap |
Restructuring Reserve Current
RestructuringReserveCurrent
|
1286000 | usd |
CY2022Q4 | us-gaap |
Restructuring Reserve Current
RestructuringReserveCurrent
|
2751000 | usd |
CY2023Q1 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
5132000 | usd |
CY2022Q4 | us-gaap |
Other Accrued Liabilities Current
OtherAccruedLiabilitiesCurrent
|
7413000 | usd |
CY2023Q1 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
46367000 | usd |
CY2022Q4 | us-gaap |
Accrued Liabilities Current
AccruedLiabilitiesCurrent
|
70997000 | usd |
CY2020Q2 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
175000000 | shares |
CY2023Q1 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
350000000 | shares |
CY2023Q1 | us-gaap |
Common Stock Shares Authorized
CommonStockSharesAuthorized
|
350000000 | shares |
CY2023Q1 | us-gaap |
Common Stock Par Or Stated Value Per Share
CommonStockParOrStatedValuePerShare
|
0.00001 | |
CY2023Q1 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
185835946 | shares |
CY2023Q1 | us-gaap |
Common Stock Shares Issued
CommonStockSharesIssued
|
185835946 | shares |
CY2022Q4 | us-gaap |
Common Stock Shares Outstanding
CommonStockSharesOutstanding
|
184135714 | shares |
CY2022Q4 | us-gaap |
Common Stock Shares Issued
CommonStockSharesIssued
|
184135714 | shares |
CY2023Q1 | us-gaap |
Preferred Stock Shares Authorized
PreferredStockSharesAuthorized
|
25000000 | shares |
CY2023Q1 | us-gaap |
Preferred Stock Par Or Stated Value Per Share
PreferredStockParOrStatedValuePerShare
|
0.00001 | |
CY2022Q4 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2023Q1 | us-gaap |
Preferred Stock Shares Issued
PreferredStockSharesIssued
|
0 | shares |
CY2022Q4 | us-gaap |
Preferred Stock Shares Outstanding
PreferredStockSharesOutstanding
|
0 | shares |
CY2023Q1 | akba |
Number Of Stock Incentive Plans
NumberOfStockIncentivePlans
|
1 | stock_incentive_plan |
CY2023Q1 | us-gaap |
Operating Lease Cost
OperatingLeaseCost
|
1800000 | usd |
CY2023Q1 | us-gaap |
Operating Lease Payments
OperatingLeasePayments
|
1700000 | usd |
CY2022Q1 | us-gaap |
Operating Lease Payments
OperatingLeasePayments
|
1800000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Remainder Of Fiscal Year
LesseeOperatingLeaseLiabilityPaymentsRemainderOfFiscalYear
|
5248000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Next Twelve Months
LesseeOperatingLeaseLiabilityPaymentsDueNextTwelveMonths
|
8162000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Two
LesseeOperatingLeaseLiabilityPaymentsDueYearTwo
|
8289000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Three
LesseeOperatingLeaseLiabilityPaymentsDueYearThree
|
6132000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Four
LesseeOperatingLeaseLiabilityPaymentsDueYearFour
|
2570000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due Year Five
LesseeOperatingLeaseLiabilityPaymentsDueYearFive
|
9631000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
|
40032000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Payments Due
LesseeOperatingLeaseLiabilityPaymentsDue
|
40032000 | usd |
CY2023Q1 | us-gaap |
Lessee Operating Lease Liability Undiscounted Excess Amount
LesseeOperatingLeaseLiabilityUndiscountedExcessAmount
|
7452000 | usd |
CY2023Q1 | us-gaap |
Operating Lease Liability
OperatingLeaseLiability
|
32580000 | usd |
CY2023Q1 | us-gaap |
Research And Development Arrangement Contract To Perform For Others Costs Incurred Gross
ResearchAndDevelopmentArrangementContractToPerformForOthersCostsIncurredGross
|
77600000 | usd |
CY2023Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
20573488 | shares |
CY2022Q1 | us-gaap |
Antidilutive Securities Excluded From Computation Of Earnings Per Share Amount
AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount
|
19970534 | shares |