$AKBA
Akebia Therapeutics, Inc.

2019 Q2 Form 10-Q Financial Statement

#000156459019030771 Filed on August 08, 2019

View on sec.gov

Income Statement

Concept 2019 Q2 2018 Q2
Revenue $100.8M $48.79M
YoY Change 106.59% 71.08%
Cost Of Revenue $37.67M
YoY Change
Gross Profit $63.13M
YoY Change
Gross Profit Margin 62.63%
Selling, General & Admin $36.07M $12.54M
YoY Change 187.67% 81.71%
% of Gross Profit 57.13%
Research & Development $85.69M $71.92M
YoY Change 19.16% 64.19%
% of Gross Profit 135.73%
Depreciation & Amortization $600.0K $200.0K
YoY Change 200.0% 100.0%
% of Gross Profit 0.95%
Operating Expenses $122.7M $84.46M
YoY Change 45.23% 66.72%
Operating Profit -$59.52M -$35.66M
YoY Change 66.91% 61.1%
Interest Expense $485.0K $1.561M
YoY Change -68.93% 156.74%
% of Operating Profit
Other Income/Expense, Net $508.0K $1.593M
YoY Change -68.11% 157.77%
Pretax Income -$59.02M -$34.10M
YoY Change 73.06% 58.6%
Income Tax -$845.0K $0.00
% Of Pretax Income
Net Earnings -$58.17M -$34.07M
YoY Change 70.74% 58.33%
Net Earnings / Revenue -57.71% -69.82%
Basic Earnings Per Share
Diluted Earnings Per Share -$492.0K -$599.3K
COMMON SHARES
Basic Shares Outstanding 117.9M
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q2 2018 Q2
SHORT-TERM ASSETS
Cash & Short-Term Investments $136.8M $370.0M
YoY Change -63.03% 16.86%
Cash & Equivalents $87.21M $163.5M
Short-Term Investments $49.55M $206.4M
Other Short-Term Assets $28.60M $5.200M
YoY Change 450.0% -53.57%
Inventory $122.1M
Prepaid Expenses
Receivables $28.89M $100.0K
Other Receivables $0.00 $0.00
Total Short-Term Assets $316.4M $407.4M
YoY Change -22.34% 22.56%
LONG-TERM ASSETS
Property, Plant & Equipment $10.90M $3.700M
YoY Change 194.68% 27.59%
Goodwill $55.05M
YoY Change
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $100.5M $2.600M
YoY Change 3766.88% 73.33%
Total Long-Term Assets $507.1M $6.400M
YoY Change 7823.94% 45.45%
TOTAL ASSETS
Total Short-Term Assets $316.4M $407.4M
Total Long-Term Assets $507.1M $6.400M
Total Assets $823.5M $413.8M
YoY Change 99.02% 22.86%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $19.32M $4.800M
YoY Change 302.52% -52.94%
Accrued Expenses $126.0M $81.00M
YoY Change 55.53% 180.28%
Deferred Revenue $40.32M $78.61M
YoY Change -48.72%
Short-Term Debt $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $185.6M $164.4M
YoY Change 12.89% -9.46%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00
YoY Change
Other Long-Term Liabilities $29.90M $83.40M
YoY Change -64.15% -15.07%
Total Long-Term Liabilities $29.90M $83.40M
YoY Change -64.15% -15.07%
TOTAL LIABILITIES
Total Short-Term Liabilities $185.6M $164.4M
Total Long-Term Liabilities $29.90M $83.40M
Total Liabilities $304.2M $247.9M
YoY Change 22.7% -11.4%
SHAREHOLDERS EQUITY
Retained Earnings -$645.0M
YoY Change
Common Stock $1.164B $594.7M
YoY Change 95.79%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $519.4M $165.9M
YoY Change
Total Liabilities & Shareholders Equity $823.5M $413.8M
YoY Change 99.02% 22.86%

Cashflow Statement

Concept 2019 Q2 2018 Q2
OPERATING ACTIVITIES
Net Income -$58.17M -$34.07M
YoY Change 70.74% 58.33%
Depreciation, Depletion And Amortization $600.0K $200.0K
YoY Change 200.0% 100.0%
Cash From Operating Activities -$38.37M $9.000M
YoY Change -526.33% -63.07%
INVESTING ACTIVITIES
Capital Expenditures -$1.980M -$170.0K
YoY Change 1064.71% 13.33%
Acquisitions
YoY Change
Other Investing Activities $56.01M -$3.390M
YoY Change -1752.21% -89.25%
Cash From Investing Activities $54.04M -$3.560M
YoY Change -1617.98% -88.77%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities 8.810M 210.0K
YoY Change 4095.24% -99.54%
NET CHANGE
Cash From Operating Activities -38.37M 9.000M
Cash From Investing Activities 54.04M -3.560M
Cash From Financing Activities 8.810M 210.0K
Net Change In Cash 24.48M 5.650M
YoY Change 333.27% -85.19%
FREE CASH FLOW
Cash From Operating Activities -$38.37M $9.000M
Capital Expenditures -$1.980M -$170.0K
Free Cash Flow -$36.39M $9.170M
YoY Change -496.84% -62.6%

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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%; vertical-align:top">&#174;</sup> (ferric citrate) is currently approved by the United States Food and Drug Administration, or FDA, and marketed for two indications in the United States, or the U.S.: the control of serum phosphorus levels in adult patients with chronic kidney disease, or CKD, on dialysis, or DD-CKD, and the treatment of iron deficiency anemia, or IDA, in adult patients with CKD not on dialysis, or NDD-CKD. </font>Ferric citrate is also approved and marketed in Japan as an oral treatment for the improvement of hyperphosphatemia in patients with DD-CKD and NDD-CKD under the trade name Riona<sup style="font-size:85%; vertical-align:top">&#174;</sup> (ferric citrate hydrate) and is approved, but not currently marketed, in the European Union as an oral treatment for the control of hyperphosphatemia in adult patients with DD-CKD and NDD-CKD under the trade name Fexeric<sup style="font-size:85%; vertical-align:top">&#174;</sup><sup style="font-size:85%; vertical-align:top"> </sup>(ferric citrate). <font style="Background-color:#FFFFFF;color:#000000;">The Company&#8217;s lead investigational product candidate, vadadustat, is an oral therapy in Phase 3 development for two indications: anemia due to CKD in adult patients with DD-CKD and anemia due to CKD in adult patients with NDD-CKD.&nbsp;&nbsp;The Company believes vadadustat has the potential to set a new standard of care in the treatment of anemia due to CKD, acting via a novel hypoxia-inducible factor, or HIF, pathway. HIF is the primary regulator of the production of red blood cells, or RBCs, in the body, as well as other important metabolic functions.</font></p> <p style="margin-top:12pt;margin-bottom:0pt;text-indent:0%;color:#000000;font-family:Times New Roman;font-size:10pt;font-weight:normal;font-style:normal;text-transform:none;font-variant: normal;"><font style="Background-color:#FFFFFF;">On December 12, 2018, the Company completed a merger with Keryx Biopharmaceuticals, Inc., or Keryx, or the Merger. Pursuant to the terms and conditions of the Agreement and Plan of Merger, or the Merger Agreement, each share of Keryx common stock, or Keryx Share, issued and outstanding immediately prior to the effective time of the Merger, or the Effective Time, was cancelled and converted into 0.37433, or the Exchange Multiplier, fully paid and non-assessable shares of Akebia common stock, or Akebia Shares, resulting in the issuance of an aggregate of 59,270,410 Akebia Shares. </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;">We expect our cash resources, including committed research and development funding from collaborators, to fund our current operating plan beyond the next twelve months, into the third quarter of 2020.&#160; However, on a quarterly basis, we are 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, our 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 our control&#8221; under the accounting standards, we are not permitted to include it in our ASC 205-40 analysis. The result of our ASC 205-40 analysis is that there is &#8220;substantial doubt&#8221; that we will have sufficient funds to satisfy our 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 offerings, 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> <p style="margin-bottom:0pt;margin-top:0pt;text-indent:0%;font-size:9pt;">&nbsp;</p>
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