2023 Q2 Form 10-Q Financial Statement

#000162828023016258 Filed on May 08, 2023

View on sec.gov

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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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
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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 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>
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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

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akba-20230331_cal.xml Edgar Link unprocessable
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