2014 Q1 Form 10-K Financial Statement

#000119312514102619 Filed on March 17, 2014

View on sec.gov

Income Statement

Concept 2014 Q1 2013 Q4 2013
Revenue $97.64K $140.0K $536.0K
YoY Change -32.24% 16.67% 92.81%
Cost Of Revenue $918.5K -$100.0K $4.341M
YoY Change -14.97% -110.31% 112.59%
Gross Profit -$820.9K $240.0K -$3.805M
YoY Change -12.31% -128.24% 115.7%
Gross Profit Margin -840.74% 171.43% -709.89%
Selling, General & Admin $3.200M $3.100M $15.54M
YoY Change -25.41% -21.52% 9.64%
% of Gross Profit 1291.67%
Research & Development $707.8K $540.0K $3.782M
YoY Change -43.91% -58.14% -44.32%
% of Gross Profit 225.0%
Depreciation & Amortization $700.0K $650.0K $2.434M
YoY Change 40.0% 66.67% 154.34%
% of Gross Profit 270.83%
Operating Expenses $3.911M $3.640M $20.33M
YoY Change -29.52% -30.53% -3.02%
Operating Profit -$4.732M -$3.400M -$24.13M
YoY Change -27.03% -44.17% 6.2%
Interest Expense $1.199K -$210.0K $564.0K
YoY Change -97.54% 1780.0%
% of Operating Profit
Other Income/Expense, Net -$3.248M $10.00K -$1.814M
YoY Change 12286.48% 0.0% -3588.46%
Pretax Income -$7.980M -$4.610M -$25.95M
YoY Change 22.58% -24.18% 14.47%
Income Tax $0.00 $0.00 $0.00
% Of Pretax Income
Net Earnings -$7.981M -$4.610M -$25.95M
YoY Change 22.56% -24.18% 14.44%
Net Earnings / Revenue -8173.66% -3292.86% -4841.04%
Basic Earnings Per Share
Diluted Earnings Per Share -$8.143M -$5.011M -$30.17M
COMMON SHARES
Basic Shares Outstanding 47.76M shares 47.37M shares
Diluted Shares Outstanding

Balance Sheet

Concept 2014 Q1 2013 Q4 2013
SHORT-TERM ASSETS
Cash & Short-Term Investments $8.120M $3.780M $3.780M
YoY Change -62.49% -51.91% -51.91%
Cash & Equivalents $8.123M $3.783M $3.780M
Short-Term Investments
Other Short-Term Assets $470.0K $880.0K $880.0K
YoY Change -46.59% -9.28% -9.28%
Inventory $5.648M $5.631M $5.630M
Prepaid Expenses
Receivables $34.12K $57.00K $60.00K
Other Receivables $0.00 $0.00 $0.00
Total Short-Term Assets $14.27M $10.35M $10.35M
YoY Change -38.31% 6.9% 6.92%
LONG-TERM ASSETS
Property, Plant & Equipment $2.995M $3.691M $3.690M
YoY Change -64.76% -49.78% -49.8%
Goodwill
YoY Change
Intangibles $40.53K $42.00K
YoY Change -10.64%
Long-Term Investments
YoY Change
Other Assets $48.00K $48.00K $50.00K
YoY Change -70.0% -42.86% -73.68%
Total Long-Term Assets $3.084M $3.781M $3.780M
YoY Change -64.59% -50.16% -50.2%
TOTAL ASSETS
Total Short-Term Assets $14.27M $10.35M $10.35M
Total Long-Term Assets $3.084M $3.781M $3.780M
Total Assets $17.35M $14.13M $14.13M
YoY Change -45.5% -18.17% -18.18%
SHORT-TERM LIABILITIES
YoY Change
Accounts Payable $1.311M $1.479M $1.480M
YoY Change 20.29% -20.05% -20.0%
Accrued Expenses $819.9K $844.0K $840.0K
YoY Change -7.88% -11.72% -12.5%
Deferred Revenue
YoY Change
Short-Term Debt $0.00 $0.00 $0.00
YoY Change
Long-Term Debt Due
YoY Change
Total Short-Term Liabilities $10.86M $5.652M $5.650M
YoY Change 380.51% 87.21% 87.09%
LONG-TERM LIABILITIES
Long-Term Debt $0.00 $0.00 $0.00
YoY Change -100.0%
Other Long-Term Liabilities $140.0K $180.0K $180.0K
YoY Change -83.53% -35.71% -35.71%
Total Long-Term Liabilities $138.9K $184.0K $180.0K
YoY Change -97.74% -33.33% -35.71%
TOTAL LIABILITIES
Total Short-Term Liabilities $10.86M $5.652M $5.650M
Total Long-Term Liabilities $138.9K $184.0K $180.0K
Total Liabilities $11.00M $5.836M $5.840M
YoY Change 30.93% 77.12% 77.51%
SHAREHOLDERS EQUITY
Retained Earnings -$176.1M -$168.1M
YoY Change 18.25%
Common Stock $182.5M $176.4M
YoY Change 12.98%
Preferred Stock
YoY Change
Treasury Stock (at cost)
YoY Change
Treasury Stock Shares
Shareholders Equity $6.355M $8.296M $8.300M
YoY Change
Total Liabilities & Shareholders Equity $17.35M $14.13M $14.13M
YoY Change -45.5% -18.17% -18.18%

Cashflow Statement

Concept 2014 Q1 2013 Q4 2013
OPERATING ACTIVITIES
Net Income -$7.981M -$4.610M -$25.95M
YoY Change 22.56% -24.18% 14.44%
Depreciation, Depletion And Amortization $700.0K $650.0K $2.434M
YoY Change 40.0% 66.67% 154.34%
Cash From Operating Activities -$7.120M -$3.900M -$19.41M
YoY Change 16.91% -22.47% 0.99%
INVESTING ACTIVITIES
Capital Expenditures $0.00 -$320.0K $5.188M
YoY Change -100.0% -87.15% -15.75%
Acquisitions
YoY Change
Other Investing Activities
YoY Change
Cash From Investing Activities $0.00 -$320.0K -$5.190M
YoY Change -100.0% -87.15% -15.75%
FINANCING ACTIVITIES
Cash Dividend Paid
YoY Change
Common Stock Issuance & Retirement, Net $11.46M $21.17M
YoY Change -27.22% 307.04%
Debt Paid & Issued, Net $6.425M
YoY Change
Cash From Financing Activities 11.46M 5.380M 20.52M
YoY Change -46.75% 153.77% 290.86%
NET CHANGE
Cash From Operating Activities -7.120M -3.900M -19.41M
Cash From Investing Activities 0.000 -320.0K -5.190M
Cash From Financing Activities 11.46M 5.380M 20.52M
Net Change In Cash 4.340M 1.160M -4.080M
YoY Change -68.53% -121.48% -79.73%
FREE CASH FLOW
Cash From Operating Activities -$7.120M -$3.900M -$19.41M
Capital Expenditures $0.00 -$320.0K $5.188M
Free Cash Flow -$7.120M -$3.580M -$24.60M
YoY Change -7.91% 40.94% -3.07%

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<div> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 18pt"> <b>1. Company</b></p> <!-- xbrl,body --> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 6pt; TEXT-INDENT: 8%"> MELA Sciences, Inc., a Delaware corporation (the &#x201C;Company&#x201D;), is a medical device company focused on the commercialization of our flagship product, MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> , the further design and development of MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> and our technology. MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> is a non-invasive, point-of-care (in the doctor&#x2019;s office) instrument to aid in the detection of melanoma. MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> features a hand-held component that emits light of multiple wavelengths to capture digital data from clinically atypical pigmented skin lesions. The data are then analyzed utilizing sophisticated classification algorithms that were &#x2018;trained&#x2019; on our proprietary database of melanomas and benign lesions. This then provides information to assist in the management of the patient&#x2019;s disease, including information useful in the decision of whether to biopsy the lesion.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 4%"> The components of the MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> system include:</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 6pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td width="1%">&#xA0;</td> <td valign="top" width="2%" align="left">&#x2022;</td> <td valign="top" width="1%">&#xA0;</td> <td valign="top" align="left">a <i>hand-held component</i>, which employs high precision optics and multi-spectral illumination (multiple colors of light including near infra-red);</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 6pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td width="1%">&#xA0;</td> <td valign="top" width="2%" align="left">&#x2022;</td> <td valign="top" width="1%">&#xA0;</td> <td valign="top" align="left">a <i>proprietary database</i> of pigmented skin lesions, believed to be the largest positive prospective database to date in the U.S.; and</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 6pt; MARGIN-TOP: 0pt"> &#xA0;</p> <table style="FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; BORDER-COLLAPSE: collapse" cellspacing="0" cellpadding="0" width="100%" border="0"> <tr> <td width="1%">&#xA0;</td> <td valign="top" width="2%" align="left">&#x2022;</td> <td valign="top" width="1%">&#xA0;</td> <td valign="top" align="left"><i>lesion classifiers</i>, which are sophisticated mathematical algorithms that extract lesion feature information and classify lesions.</td> </tr> </table> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 8%"> In November 2011, the Company received written approval from the U.S. Food and Drug Administration (&#x201C;FDA&#x201D;) for the MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> Pre-Market Approval (&#x201C;PMA&#x201D;) application and in September 2011 received Conformite Europeenne (&#x201C;CE&#x201D;) Mark approval for MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>. On March&#xA0;7, 2012, the Company installed the first commercial MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> systems, and proceeded with the commercial launch of MelaFind <sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>. We are currently conducting a Post-Approval Study (&#x201C;PAS&#x201D;) evaluating the sensitivity and false positive rate of physicians after using MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup>.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 8%"> In 2012 the Company evolved from a research and development company to a commercial enterprise. The launch of MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> in 2012, and the subsequent commercialization activities following the launch did not meet the Company&#x2019;s initial goals and objectives. Revenues were lower than forecasted and expenses continued to increase throughout 2012 and into 2013. Our cash used in operating activities for the year ended December&#xA0;31, 2013 and December&#xA0;31, 2012 totaled $19,413 and $19,224, respectively, and net revenues totaled $536 and $278, respectively.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 8%"> In mid 2013, a significant cost reduction program was put into place (see Note 16). On November&#xA0;11, 2013, a new CEO was brought on board and a newly refocused &#x201C;Go-to-Market&#x201D; strategy focusing on key institutions, opinion leaders and dermatologists who treat many of the patients at high risk for melanoma was adopted. As part of this strategy, in late December, we elected to change our business model from a rental to a sale model for the MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> device. The Company has reduced its costs, brought new and experienced talent to its management team and has reconsidered the approach to the commercialization of the MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> device. The Company has also begun the process of obtaining a coverage determination from the Centers for Medicare&#xA0;&amp; Medicaid Services, the federal agency that administers Medicare, in order to obtain reimbursement by Medicare for use of the MelaFind<sup style="FONT-SIZE: 85%; VERTICAL-ALIGN: top">&#xAE;</sup> device. The Company anticipates that this process could take up to two years. Once a coverage determination has been made, the Company plans to seek reimbursement by Medicaid, Medicare and other third-party payers.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 8%"> On August&#xA0;22, 2013, the Company received a notice from The NASDAQ Stock Market that, for the previous 30 consecutive business days, the Company was not in compliance with a Nasdaq rule for continued listing that requires a listed company&#x2019;s common stock to maintain a minimum bid price of $1.00 per share. The Company was granted an automatic 180 grace period by NASDAQ in which to regain compliance. On February&#xA0;19, 2014, we were notified by NASDAQ that the Company was eligible for an additional 180 day grace period and has until August&#xA0;18, 2014 to regain compliance with NASDAQ&#x2019;s minimum bid price requirement.</p> <p style="MARGIN-BOTTOM: 0pt; FONT-SIZE: 10pt; FONT-FAMILY: Times New Roman; MARGIN-TOP: 12pt; TEXT-INDENT: 8%"> On October&#xA0;17, 2013, the FDA sent the Company a letter stating the information in the August&#xA0;8, 2013 progress report with respect to the PAS was inadequate to allow the agency to complete its review and therefore the FDA asked for additional information. Because of rate of accrual issues, the FDA&#x2019;s letter informed the Company that its study status was revised on the FDA&#x2019;s website to &#x201C;Progress Inadequate.&#x201D; On September&#xA0;9, 2013, the Company placed this study on hold to investigate enrollment. On November&#xA0;15, 2013, the Company responded to the FDA&#x2019;s letter, outlining an enrollment plan as well as a new enrollment schedule. On January&#xA0;2, 2014, the FDA prompted an interactive review process to obtain further additional information regarding the Company&#x2019;s response. On January&#xA0;13, 2014, the Company&#x2019;s enrollment plan and enrollment schedule was approved by the FDA and the interactive review process was closed as the FDA deemed the Company has sufficiently met the reporting expectations of the report. The Company&#x2019;s new study timeline was approved for study restart in January 2014, steps to restart the study have been initiated. The FDA noted in their January 13, 2014 email that the status would remain as &#x201C;Progress Inadequate&#x201D; and that the status would be reassessed upon review of the next interim report date, February 8, 2014, based on the newly approved January 2014 restart timeline. As of the Company&#x2019;s February 24, 2014 teleconference with the FDA, they noted that they have not had time to read our February 8, 2014 report and therefore the status has not been reviewed.</p> </div>
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CY2012 us-gaap Income Tax Reconciliation Change In Deferred Tax Assets Valuation Allowance
IncomeTaxReconciliationChangeInDeferredTaxAssetsValuationAllowance
9069000
CY2012 us-gaap Depreciation And Amortization
DepreciationAndAmortization
970000
CY2012 us-gaap Cash And Cash Equivalents Period Increase Decrease
CashAndCashEquivalentsPeriodIncreaseDecrease
-20135000
CY2012 us-gaap Write Off Of Deferred Debt Issuance Cost
WriteOffOfDeferredDebtIssuanceCost
62000
CY2012 us-gaap Net Cash Provided By Used In Investing Activities Continuing Operations
NetCashProvidedByUsedInInvestingActivitiesContinuingOperations
-6158000
CY2012 us-gaap Proceeds From Issuance Of Common Stock
ProceedsFromIssuanceOfCommonStock
5202000
CY2012 us-gaap Income Tax Reconciliation Income Tax Expense Benefit At Federal Statutory Income Tax Rate
IncomeTaxReconciliationIncomeTaxExpenseBenefitAtFederalStatutoryIncomeTaxRate
7709000
CY2012 us-gaap Cost Of Revenue
CostOfRevenue
2042000
CY2012 us-gaap Research And Development Expense
ResearchAndDevelopmentExpense
6792000
CY2012 us-gaap Increase Decrease In Other Operating Liabilities
IncreaseDecreaseInOtherOperatingLiabilities
10000
CY2012 us-gaap Proceeds From Stock Options Exercised
ProceedsFromStockOptionsExercised
45000
CY2012 us-gaap Depreciation
Depreciation
957000
CY2012 us-gaap Lease And Rental Expense
LeaseAndRentalExpense
483000
CY2012 us-gaap Employee Service Share Based Compensation Cash Received From Exercise Of Stock Options
EmployeeServiceShareBasedCompensationCashReceivedFromExerciseOfStockOptions
45000
CY2012 us-gaap Defined Benefit Plan Contributions By Employer
DefinedBenefitPlanContributionsByEmployer
151000
CY2012 us-gaap Operating Expenses
OperatingExpenses
20961000
CY2012 us-gaap Income Tax Expense Benefit
IncomeTaxExpenseBenefit
CY2012 mela Stock Issued During Period Value Stock Options Exercised Cashless
StockIssuedDuringPeriodValueStockOptionsExercisedCashless
CY2012 mela Weighted Average Remaining Contractual Term In Years Granted
WeightedAverageRemainingContractualTermInYearsGranted
P9Y6M
CY2012 mela Reclassification From Other Assets To Property And Equipment
ReclassificationFromOtherAssetsToPropertyAndEquipment
522000
CY2012 mela Share Based Compensation Arrangement By Share Based Payment Award Award Requisite Service Period For Directors
ShareBasedCompensationArrangementByShareBasedPaymentAwardAwardRequisiteServicePeriodForDirectors
P1Y
CY2012 mela Aggregate Intrinsic Value For Forfeited Or Expired
AggregateIntrinsicValueForForfeitedOrExpired
27000

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