2019 Q4 Form 10-Q Financial Statement

#000110820519000020 Filed on November 05, 2019

View on sec.gov

Income Statement

Concept 2019 Q4 2019 Q3 2018 Q3
Revenue $3.287M $2.856M $2.847M
YoY Change 19.31% 0.32% 16.49%
Cost Of Revenue $160.0K $150.0K $150.0K
YoY Change 6.67% 0.0% 25.0%
Gross Profit $3.130M $2.710M $2.690M
YoY Change 19.92% 0.74% 15.95%
Gross Profit Margin 95.22% 94.89% 94.49%
Selling, General & Admin $3.000M $2.890M $4.130M
YoY Change -1.32% -30.02% 21.11%
% of Gross Profit 95.85% 106.64% 153.53%
Research & Development $7.460M $5.147M $4.983M
YoY Change 58.39% 3.29% -62.76%
% of Gross Profit 238.34% 189.93% 185.24%
Depreciation & Amortization $30.00K $30.00K $40.00K
YoY Change -25.0% -25.0% -42.86%
% of Gross Profit 0.96% 1.11% 1.49%
Operating Expenses $10.46M $5.147M $4.983M
YoY Change 34.97% 3.29% -62.76%
Operating Profit -$7.334M -$5.323M -$6.417M
YoY Change 42.46% -17.05% -55.66%
Interest Expense $100.0K $0.00 $972.0K
YoY Change -112.66% -100.0% -12.35%
% of Operating Profit
Other Income/Expense, Net -$1.380M -$1.113M -$806.0K
YoY Change 38.09% -18.26%
Pretax Income -$8.610M -$6.440M -$7.220M
YoY Change 44.95% -10.8% -53.3%
Income Tax
% Of Pretax Income
Net Earnings -$8.609M -$6.436M -$7.223M
YoY Change 44.91% -10.9% -53.27%
Net Earnings / Revenue -261.91% -225.35% -253.71%
Basic Earnings Per Share
Diluted Earnings Per Share -$259.3K -$194.0K -$217.7K
COMMON SHARES
Basic Shares Outstanding 33.20M shares 33.20M shares 33.18M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2019 Q4 2019 Q3 2018 Q3
SHORT-TERM ASSETS
Cash & Short-Term Investments $20.50M $28.00M $30.80M
YoY Change -15.64% -9.09% -55.49%
Cash & Equivalents $15.43M $21.40M $25.56M
Short-Term Investments $5.100M $6.700M $5.300M
Other Short-Term Assets $1.300M $1.800M $1.100M
YoY Change 62.5% 63.64% -21.43%
Inventory
Prepaid Expenses
Receivables $3.244M $2.897M $2.855M
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $25.00M $32.68M $34.82M
YoY Change -10.58% -6.12% -52.31%
LONG-TERM ASSETS
Property, Plant & Equipment $154.0K $203.0K $312.0K
YoY Change -42.32% -34.94% -18.75%
Goodwill $9.000M $8.982M $8.982M
YoY Change 0.2% 0.0% 0.0%
Intangibles
YoY Change
Long-Term Investments
YoY Change
Other Assets $3.000K $3.000K $3.000K
YoY Change 50.0% 0.0% 0.0%
Total Long-Term Assets $10.10M $9.561M $9.450M
YoY Change 7.44% 1.17% 0.86%
TOTAL ASSETS
Total Short-Term Assets $25.00M $32.68M $34.82M
Total Long-Term Assets $10.10M $9.561M $9.450M
Total Assets $35.11M $42.24M $44.27M
YoY Change -6.04% -4.57% -46.26%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $4.465M $2.478M $3.008M
YoY Change 53.49% -17.62% -53.86%
Accrued Expenses $1.910M $1.831M $3.300M
YoY Change -44.75% -44.52% 30.54%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due $0.00 $0.00 $6.900M
YoY Change -100.0% -100.0% 34.87%
Total Short-Term Liabilities $6.541M $4.718M $13.23M
YoY Change -50.63% -64.35% -6.57%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $30.20M
YoY Change -100.0% -100.0% -20.02%
Other Long-Term Liabilities $0.00 $0.00 $29.00K
YoY Change -100.0% -100.0%
Total Long-Term Liabilities $0.00 $0.00 $30.23M
YoY Change -100.0% -100.0% -19.94%
TOTAL LIABILITIES
Total Short-Term Liabilities $6.541M $4.718M $13.23M
Total Long-Term Liabilities $0.00 $0.00 $30.23M
Total Liabilities $69.02M $68.26M $43.48M
YoY Change 64.87% 56.99% -16.25%
SHAREHOLDERS EQUITY
Retained Earnings -$1.017B -$1.000B -$978.9M
YoY Change 3.26% 2.16% 3.67%
Common Stock $983.1M $982.4M $979.7M
YoY Change 0.28% 0.27% 0.36%
Preferred Stock
YoY Change
Treasury Stock (at cost) $0.00
YoY Change -100.0%
Treasury Stock Shares 0.000 shares
Shareholders Equity -$33.91M -$26.02M $782.0K
YoY Change
Total Liabilities & Shareholders Equity $35.11M $42.24M $44.27M
YoY Change -6.04% -4.57% -46.26%

Cashflow Statement

Concept 2019 Q4 2019 Q3 2018 Q3
OPERATING ACTIVITIES
Net Income -$8.609M -$6.436M -$7.223M
YoY Change 44.91% -10.9% -53.27%
Depreciation, Depletion And Amortization $30.00K $30.00K $40.00K
YoY Change -25.0% -25.0% -42.86%
Cash From Operating Activities -$5.600M -$6.710M -$8.230M
YoY Change 13.36% -18.47% -50.06%
INVESTING ACTIVITIES
Capital Expenditures $0.00 $0.00 -$10.00K
YoY Change -100.0% -50.0%
Acquisitions
YoY Change
Other Investing Activities $1.540M $1.460M $4.690M
YoY Change -66.88% -68.87% -5.44%
Cash From Investing Activities $1.550M $1.450M $4.680M
YoY Change -66.67% -69.02% -5.07%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net
YoY Change
Debt Paid & Issued, Net
YoY Change
Cash From Financing Activities -1.060M -610.0K -1.360M
YoY Change -35.37% -55.15% -103.92%
NET CHANGE
Cash From Operating Activities -5.600M -6.710M -8.230M
Cash From Investing Activities 1.550M 1.450M 4.680M
Cash From Financing Activities -1.060M -610.0K -1.360M
Net Change In Cash -5.110M -5.870M -4.910M
YoY Change 164.77% 19.55% -121.2%
FREE CASH FLOW
Cash From Operating Activities -$5.600M -$6.710M -$8.230M
Capital Expenditures $0.00 $0.00 -$10.00K
Free Cash Flow -$5.600M -$6.710M -$8.220M
YoY Change 13.36% -18.37% -50.06%

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<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-weight:bold;text-decoration:underline;">Nature of Business</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Curis, Inc. is a biotechnology company focused on the development of first-in-class and innovative therapeutics for the treatment of cancer. As used throughout these Condensed Consolidated Financial Statements, the term &#8220;the Company&#8221; refers to the business of Curis, Inc. and its wholly owned subsidiaries, except where the context otherwise requires, and the term &#8220;Curis&#8221; refers to Curis, Inc.</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company conducts its research and development programs both internally and through strategic collaborations. The Company&#8217;s clinical stage drug candidates are fimepinostat, CA-4948, and CA-170:</font></div><div style="line-height:120%;text-align:left;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;"><br clear="none"/></font></div><table cellpadding="0" cellspacing="0" style="padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:54px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:36px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Fimepinostat is currently being explored in clinical studies in patients with MYC-altered diffuse large B-cell lymphoma (&#8220;DLBCL&#8221;) and solid tumors and has been granted Orphan Drug Designation and Fast Track Designation for the treatment of DLBCL by the U.S. Food and Drug Administration, (&#8220;FDA&#8221;) in April 2015 and May 2018, respectively. The Company has begun enrollment in a Phase 1 combination study with venetoclax in DLBCL patients, including patients with translocations in both MYC and the BCL2 gene, also referred to as double-hit lymphoma, or high grade B-cell lymphoma (&#8220;HGBL&#8221;). The Company expects to report initial clinical data from this combination study in the fourth quarter of 2019. </font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:54px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:36px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">CA-4948 is being tested in a dose escalating clinical trial in patients with non-Hodgkin lymphomas, including those with myeloid differentiation primary response 88, or MYD88, alterations. The Company is currently planning to initiate a separate Phase 1 trial for acute myeloid leukemia (&#8220;AML&#8221;) and myelodysplastic syndromes (&#8220;MDS&#8221;) patients. The Company expects to report further clinical data from the study in the fourth quarter of 2019.</font></div></td></tr></table><table cellpadding="0" cellspacing="0" style="padding-bottom:8px;font-family:Times New Roman; font-size:10pt;"><tr><td style="width:54px;" rowspan="1" colspan="1"></td><td rowspan="1" colspan="1"></td></tr><tr><td style="vertical-align:top" rowspan="1" colspan="1"><div style="line-height:120%;font-size:10pt;padding-left:36px;"><font style="font-family:inherit;font-size:10pt;">&#8226;</font></div></td><td style="vertical-align:top;" rowspan="1" colspan="1"><div style="line-height:120%;text-align:left;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">CA-170 is currently undergoing testing in a clinical study in patients with mesothelioma.&#160;The Company will announce initial data in conjunction with the Society for Immunotherapy of Cancer conference in November 2019. Based on this data, no further patients will be enrolled in the study. The Company is currently evaluating future studies for CA-170.</font></div></td></tr></table><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company&#8217;s pipeline also includes CA-327, which is a pre-Investigational New Drug (&#8220;IND&#8221;) stage oncology drug candidate. </font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company is party to a collaboration with Genentech Inc. (&#8220;Genentech&#8221;), a member of the Roche Group, under which F. Hoffmann-La Roche Ltd (&#8220;Roche&#8221;) and Genentech are commercializing Erivedge</font><font style="font-family:inherit;font-size:10pt;"><sup style="vertical-align:top;line-height:120%;font-size:7pt">TM </sup></font><font style="font-family:inherit;font-size:10pt;">(vismodegib), a first-in-class orally administered small molecule Hedgehog signaling pathway inhibitor. Erivedge is approved for the treatment of advanced basal cell carcinoma (&#8220;BCC&#8221;).</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">In January 2015, and as amended in September 2016, the Company entered into a collaboration, option and license agreement focused on immuno-oncology and selected precision oncology targets with Aurigene Discovery Technologies Limited (&#8220;Aurigene&#8221;).</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The collaboration with Aurigene comprises multiple programs, and the Company has the option to exclusively license each program, including data, intellectual property and compounds associated therewith, once a development candidate is nominated within such program. In October 2015, the Company exercised options to license </font><font style="font-family:inherit;font-size:10pt;">two</font><font style="font-family:inherit;font-size:10pt;"> programs under this collaboration. The first licensed program is in the immuno-oncology field and the Company has named CA-170, an orally available small molecule antagonist of two immune checkpoints, V-domain Ig suppressor of T-cell activation (&#8220;VISTA&#8221;) and programmed death ligand-1 (&#8220;PDL1&#8221;), as the development candidate from this program. The second licensed program is in the precision oncology field and the Company has named CA-4948, an orally available small molecule inhibitor of Interleukin-1 receptor-associated kinase 4 (&#8220;IRAK4&#8221;) as the development candidate. In October 2016, the Company exercised its option to license a third program in the collaboration, and designated CA-327, a distinct orally available small molecule antagonist of two immune checkpoints PDL1 and T-cell immunoglobulin and mucin domain containing protein-3 (&#8220;TIM3&#8221;) as the development candidate from this program. In March 2018, the Company exercised its option to license a fourth program, which is an immuno-oncology program. </font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company operates in a single reportable segment, which is the research and development of innovative cancer therapeutics. The Company expects that any products that are successfully developed and commercialized would be used in the healthcare industry and would be regulated in the United States by the FDA and in overseas markets by similar regulatory authorities.</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company is subject to risks common to companies in the biotechnology industry as well as risks that are specific to the Company&#8217;s business, including, but not limited to: the Company&#8217;s ability to advance and expand its research and development programs, the Company&#8217;s reliance on Aurigene to successfully discover and preclinically develop drug candidates under the parties&#8217; collaboration agreement, the Company&#8217;s reliance on Roche and Genentech to successfully commercialize Erivedge in the approved indication of advanced BCC and to progress its clinical development in indications other than BCC, the Company&#8217;s ability to obtain adequate financing to fund its operations, the ability of the Company and its wholly owned subsidiary, Curis Royalty, LLC (&#8220;Curis Royalty&#8221;), to satisfy the terms of the royalty interest purchase agreement (the &#8220;Oberland Purchase Agreement&#8221;) with entities managed by Oberland Capital Management, LLC (&#8220;Purchasers&#8221;), the Company&#8217;s ability to obtain and maintain necessary intellectual property protection, development by the Company&#8217;s competitors of new or better technological innovations, the Company's dependence on key personnel, the Company&#8217;s ability to comply with regulatory requirements, the Company's ability to obtain and maintain applicable regulatory approvals and commercialize any approved product candidates, and the Company&#8217;s ability to execute on its overall business strategies.</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company&#8217;s future operating results will largely depend on the progress of drug candidates currently in its development pipeline and the magnitude of payments that it may receive and make under its current and potential future collaborations. The results of the Company&#8217;s operations have varied and will likely continue to vary significantly from year to year and quarter to quarter and depend on a number of factors, including, but not limited to: the timing, outcome and cost of the Company&#8217;s preclinical studies and clinical trials for its drug candidates; Aurigene&#8217;s ability to successfully discover and develop preclinical programs under the Company&#8217;s collaboration with Aurigene, as well as the Company&#8217;s decision to exclusively license and further develop programs under this collaboration; Roche and Genentech&#8217;s ability to successfully commercialize Erivedge; and positive results in Roche and Genentech&#8217;s ongoing clinical trials.</font></div><div style="line-height:120%;padding-top:6px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The Company has incurred net losses and negative cash flows from operations since its inception. As of </font><font style="font-family:inherit;font-size:10pt;">September&#160;30, 2019</font><font style="font-family:inherit;font-size:10pt;">, the Company had an accumulated deficit of approximately </font><font style="font-family:inherit;font-size:10pt;">$1.0</font><font style="font-family:inherit;font-size:10pt;"> billion, and for the nine months ended </font><font style="font-family:inherit;font-size:10pt;">September&#160;30, 2019</font><font style="font-family:inherit;font-size:10pt;">, the Company incurred a net loss of </font><font style="font-family:inherit;font-size:10pt;">$23.5</font><font style="font-family:inherit;font-size:10pt;"> million and used </font><font style="font-family:inherit;font-size:10pt;">$20.6</font><font style="font-family:inherit;font-size:10pt;"> million of cash in operations. The Company expects to continue to generate net losses in the foreseeable future. The Company anticipates that its </font><font style="font-family:inherit;font-size:10pt;">$28.0</font><font style="font-family:inherit;font-size:10pt;"> million of existing cash, cash equivalents and investments at </font><font style="font-family:inherit;font-size:10pt;">September&#160;30, 2019</font><font style="font-family:inherit;font-size:10pt;"> should enable the Company to maintain its planned operations into the second half of 2020. Based on available cash resources, the Company does not have sufficient cash on hand to support current operations within the next 12 months from the date of filing this Quarterly Report on Form 10-Q. The Company&#8217;s ability to raise additional funds will depend, among other factors, on financial, economic and market conditions, many of which are outside of its control and it may be unable to raise financing when needed, or on terms favorable to the Company.&#160;If sufficient funds are not available, the Company may have to delay, reduce the scope of, or eliminate some of its research and development programs, including related clinical trials and operating expenses, potentially delaying the time to market for or preventing the marketing of any of its product candidates, which could adversely affect the Company&#8217;s business prospects and the Company&#8217;s ability to continue its operations, and would have a negative impact on the Company&#8217;s financial condition and ability to pursue its business strategies. See Note 2, &#8220;Basis of Presentation,&#8221; for additional information about the Company&#8217;s ability to continue as a going concern.</font></div></div>
us-gaap Prior Period Reclassification Adjustment Description
PriorPeriodReclassificationAdjustmentDescription
<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;font-style:italic;text-decoration:underline;">Reclassifications and Revision</font></div><div style="line-height:120%;padding-top:8px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">Certain prior period amounts have been reclassified to conform with the current period presentation.</font></div></div>
us-gaap Use Of Estimates
UseOfEstimates
<div style="font-family:Times New Roman;font-size:10pt;"><div style="line-height:120%;padding-top:8px;text-indent:30px;font-size:10pt;"><font style="font-family:inherit;font-size:10pt;">The preparation of the Company&#8217;s Condensed Consolidated Financial Statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts and disclosure of certain assets and liabilities at the balance sheet date. Such estimates include the performance obligations under the Company&#8217;s collaboration agreements; the estimated repayment term of the Company&#8217;s debt and related short- and long-term classification; the fair value of the Company&#8217;s debt; the collectability of receivables; the carrying value of property and equipment and intangible assets; and the assumptions used in the Company&#8217;s valuation of stock-based compensation and the value of certain investments and liabilities. Actual results may differ from such estimates.</font></div></div>

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