10-13-2011: Mela Sciences Inc. (MELA): Pressure Mounts on FDA To Approve Their One Major Product

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Recommendation

Mela Sciences Inc.

Jefferson Research and its "Sonar Reports" has been a feature in most of Zenith's stock review articles in the "Research" sections. Often this organization's recommenations contradict conclusions by most others. We began to wonder about it a bit, and decided to try to locate a stock that Jefferson "really liked" to test it out a bit. Jefferson didn't make it easy, as there is no summary location, and we had to simply review stock after stock, beginning to suspect that Jefferson didn't like anything! But then we landed on Mela Sciences, Inc. (MELA) which Jefferson really liked, giving it their highest possible rating, so we decided to review the company to see what Jefferson liked. As a result, we are getting very skeptical about Jefferson Research, but it is too early to count them out.

The stock Jefferson landed on was at times considered a penny stock with a high volume, Electro Optical Sciences, Inc. (EOS) The company started out with some products like dental decay detectors which apparently weren't doing too well. Then it decided to put most or all of its eggs in one basket and concentrated virtually everything on one product, a melanoma (skin cancer) detection device. It received approval for sale in Europe, but still awaits FDA approval for sale in the U.S., even though EOS was U.S. based. In February, 2010, the company changed its name to Mela Sciences, Inc., (MELA) in order to reflect its concentration in the skin cancer detection business and its one major product, the "MelaFind" device. The European approval caused its stock to shoot up, and the FDA to issue rumblings related to eventual favorable findings. The urgency of a need for the device was helpful as many doctors are unable to tell the difference between malignant and non-malignant skin cancers and so tend to "over-operate" to remove these problems. MelaFind could help avoid that.

Jefferson rates the company as having very strong financials and strong in every other category although it has yet to show a profit and is continually floating new issues to bring in capital to support the company and diluting stock share value. The ups and downs of the FDA approval process often makes one wonder if FDA officials might be corrupt somewhere with advance knowledge of pronouncements that could send shares of a one-product company like Mela soaring or crashing. They have shown the potential to have stock share price double or halve in one day.

The device is no cure for cancer, but early detection that it could promote would decrease the number of deaths due to melanoma which can be stopped if found early enough. So in a sense, Melanoma is curable, but at the same time is responsible for at least 80% of all skin cancer deaths.

In 2010, lawyers representing class action lawsuits were lining up at the door of the company, but the "charges" seemed pretty vague to us. They claimed Mela MAY have issued false and leading statements regarding the potential for their MelaFind device, after the FDA released a statement that sufficient studies had not been conducted regarding MelaFind's accuracy rate. That vague statement alone caused a 54% drop in Mela stock share price in one day. Shortly thereafter, an FDA panel recommended approval of the device and the stock soared 109% on one day. So this stock is extremely risky and subject to every whim and fancy of the U.S. FDA. The FDA maintains another clinical trial which could take another 180 days is required while the company claims the FDA violated a binding protocal agreement outlining what would be required for clinical trials which the company says have been completed, at least for restricting the use of the device to trained dermotologists.

Perhaps it was best expressed by one news organization that stated, "The FDA has created a Mela-drama!" Negative statements issued one day, positive the next, and on and on. But when Europe moved ahead on the device, it put a lot of pressure on the U.S. FDA to "stop screwing around."

So to quote a Las Vegas notariety, "You pays your money and you takes your chances." But this seems a little inconsistent with Jefferson Research's normally-conservative stance and its glowing report on a company for which much data is not even available inside that Jefferson Report. It gets "strong earnings" rating and has yet to show a profit! Even if FDA approval is granted, it has yet to find U.S. customers. Perhaps the absence of data somehow skewed the highly-computerized Jefferson Report into the extremely favorable column.

Obviously, if some company finds a cure for cancer, its stock will soar. MELA gets about as close to that as one can get for one particular form of cancer by early detection.

In fairness to Jefferson Research, if one goes by recent stock performance and forgets all the internal prejudices, its share price jumped at least 15% in the last few days with a fair amount of insider buying.



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Under current market conditions, a Zenith Index Score of 1.20 or above is required for a positive rating on this factor. 1.21 -1.30 is considered acceptable, 1.30-1.40 is consider strong and > 1.40 is considered exceptionally strong. Accounting statements in this section often contain mistakes, especially in earlier years' totals, but data is deemed sufficient for us to give a rating. More accurate financial statements follow in the next section.

MELA Sciences, Inc.              (MELA )    Sector: Healthcare
50 South Buckhout Street         Industry: Medical Instruments & Supplie
Suite 1                          Exchange: Nasdaq
Irvington, NY 10533

MELA Sciences, Inc., a medical device company, focuses on the design and
development of a non-invasive, point-of-care instrument to assist in the
detection of early melanoma. The company-Ęs principal product, MelaFind,
features a hand-held imaging device that emits multiple wavelengths of
light to capture images of suspicious pigmented skin lesions and extract
data. This product uses automatic image analysis and statistical pattern
recognition to help identify lesions to be considered for biopsy to rule
out melanoma. It consists of hand-held imaging device, which employs high
precision optics and multi-spectral illumination; database of pigmented
skin lesions; and lesion classifiers, which are mathematical algorithms
that extract lesion feature information and classify lesions. MELA
Sciences submitted the MelaFind pre-market approval application with the
U.S. Food and Drug Administration (FDA) in June 2009 and is under review
at the FDA. The company was formerly known as Electro-Optical Sciences,
Inc. and changed its name MELA Sciences, Inc. in April 2010. MELA
Sciences, Inc. was founded in 1989 and is based in Irvington, New York.

Last Trade:   6.21                     52-Week Range:   8.32 -   1.75
Trade Date:  10-12                     Avg. Volume:    868,244 Shares
Index Membership:                                  Employees:      42

Corporate Governance:
    Audit (Low Concern), Board (High Concern), Compensation
    (Medium Concern), Shareholder Rights (Low Concern).

     EPS:  -0.79     Dividend Amount: $  0.00       Yield:         0.00%
                    Ex-Dividend Date: N/A         Mkt Cap: $    156,880K
                        Payout Ratio:  0.00%

     Last Split Factor (new for old): N/A      Split Date: N/A

Key Statistics:

Enterprise Value: $    124,570K           Revenue (ttm)  : $          0K
                                             Gross Profit: $          0K
Earnings before Income Tax, Depreciation and Amortization: $    -19,790K

Enterprise Value/Revenue (ttm):  0.00           Revenue per Share: $    0.00
Enterprise Value/EBITDA (ttm):  -6.29       Qtrly Rev Growth (y to y):  0.00%


P/E Ratio (fwd projected):  0.00      P/E Ratio (current):   0.00

P/E Growth Ratio (5 yr expected): -0.16  Operating Margin:    0.00%
               Price/Sales Ratio:  0.00     Profit Margin:    0.00%
                Price/Book Value:  6.39        Book Value: $  0.90/sh.

Return on Assets: -48.62%        Net Income Avl to Common: $   -20,030K
Return on Equity: -81.33%          Diluted Earnings/Share:     $ -0.79
                              Qrtly Earnings Growth (yoy):        0.00%

Balance Sheet Items :                   Cash Flow Items (ttm):
(most recent qrtr)                      (trailing 12 mo.)

       Total Cash: $     20,940K        Operating Cash Flow:$    -19,310K
       Total Debt: $          0K        Lvgd Free Cash Flow:$    -13,590K
Total Debt/Equity:         0.00
 Total Cash/Share:      $  0.83
    Current Ratio:        17.28

Share Statistics:                       Stock Price History:

    Shares Outstanding:   25,260K       Stk 52-Week Change: -12.86%
                 Float:   24,840K       S&P 500 52-Wk Chng:   2.20%
  Sh. Short % of Float:    15.60%        50-Day Moving Avg:   3.52
           Short Ratio:     4.60        200-Day Moving Avg:   2.98
% Held by Institutions:    35.10%                     Beta:   0.30
    % Held by Insiders:     4.56%

Analysts' Estimates:               Cur. Qtr   Next Qtr  Cur. Year  Next Year
___________________________          Sep 11     Dec 11     Dec 11     Dec 12

  Average Earnings Estimate          -0.24      -0.24      -0.87      -0.83
  Average Revenue  Estimate             0M       100M        10M        -0M

Factors Comparing This Company to Its Industry Leader (1.0 = Average):

Long Term EPS Growth Rate (5 yr):  40.750      EPS Growth (Qrtly YoY):   0.000
  PEG Ratio (ttm, 5 yr expected):   3.791             P/E Ratio (ttm):   0.000
      Revenue Growth (Qrtly YoY):   0.000


Annual Income Statements:                          All numbers in thousands)
  Period Ending                          Dec31,2010   Dec31,2009   Dec31,2008

  Total Revenue                                  0            0            0
  Cost of Revenue                                0            0            0
  Gross Profit                                   0            0            0

Operating Expenses:
  Research & Development                    11,497       10,950       12,508
  Selling, General & Administrative          8,738        7,631        5,766
  Non-Recurring Expenses                         0            0            0
  Other Operating Expenses                       0            0            0
  Total Operating Expenses                       0            0            0
  Operating Income or Loss                 -20,235      -18,581      -18,274

Income from Continuing Operations:
  Total Other Income/Expenses Net              312          129          669
  Earnings Before Interest & Taxes         -19,923      -18,453      -17,605
  Interest Expense                               0            0            0
  Income Before Taxes                      -19,923      -18,453      -17,605
  Income Tax Expense                             0            0            0
  Minority Interest                              0            0            0
  Net Income from Continuing Op.s          -19,923      -18,453      -17,605

Non-recurring Events:
  Discontinued Operations                        0            0            0
  Extraordinary Items                            0            0            0
  Effect of Accounting Changes                   0            0            0
  Other Items                                    0            0            0
  Net Income                               -19,923      -18,453      -17,605

  Preferred Stock & Other Adjustmnts            0            0            0
  Net Income Avail To Common Shares        -19,923      -18,453      -17,605


Quarterly Income Statements:                           All numbers in thousands)
  Period Ending                   Jun30,2011  Mar31,2011  Dec31,2010  Sep30,2010

  Total Revenue                            0           0           0           0
  Cost of Revenue                          0           0           0           0
  Gross Profit                             0           0           0           0

Operating Expenses:
  Research & Development               2,621       2,576       3,220       2,937
  Selling, General & Adminis.          2,208       2,393       2,386       2,033
  Non-Recurring Expenses                   0           0           0           0
  Other Operating Expenses                 0           0           0           0
  Total Operating Expenses                 0           0           0           0
  Operating Income or Loss            -4,829      -4,969      -5,606      -4,970

Income from Continuing Operations:
  Total Other Income/Expenses Net         19          27         281          15
  Earnings Before Int. & Taxes        -4,810      -4,942      -5,325      -4,955
  Interest Expense                         0           0           0           0
  Income Before Taxes                 -4,810      -4,942      -5,325      -4,955
  Income Tax Expense                       0           0           0           0
  Minority Interest                        0           0           0           0
  Net Income from Continuing Op.s     -4,810      -4,942      -5,325      -4,955

Non-recurring Events:
  Discontinued Operations                  0           0           0           0
  Extraordinary Items                      0           0           0           0
  Effect of Accounting Changes             0           0           0           0
  Other Items                              0           0           0           0
  Net Income                          -4,810      -4,942      -5,325      -4,955

  Preferred Stock & Other Adj.s            0           0           0           0
  Net Income Avail To Common Shs      -4,810      -4,942      -5,325      -4,955


Annual Balance Sheets:                                All Numbers in Thousands
  Period Ending                       Dec31,2010     Dec31,2009     Dec31,2008
Current Assets:
  Cash & Cash Equivalents                 30,521         29,673         15,070
  Short Term Investments                       0              0            391
  Net Receivables                              0              0              0
  Inventory                                    0              0              0
  Other Current Assets                       524            665            376
  Total Current Assets                    31,044         30,338         15,836

  Long-Term Investments                        0              0              0
  Property, Plant & Equipt                 2,074          1,572            643
  Goodwill                                     0              0              0
  Intangible Assets                           71             83             95
  Accumulated Amortization                     0              0              0
  Other Assets                               338             48             45
  Deferred Long Term Asset Charges            62             86              0
  Total Assets                            33,589         32,127         16,620

Current Liabilities:
  Accounts Payable                         1,656          1,778          1,467
  Short/Current Long Term Debt                 0              0              0
  Other Current Liabilities                   30             33             64
  Total Current Liabilities                1,686          1,811          1,530

  Long Term Debt                               0              0              0
  Other Liabilities                            0              0              0
  Deferred LT Liability Charges              104              0              0
  Minority Interest                            0              0              0
  Negative Goodwill                            0              0              0
  Total Liabilities                        1,790          1,811          1,530

Stockholder Equity:
  Misc. Stocks Options Warrants                0              0              0
  Redeemable Perferred Stock                   0              0              0
  Preferred Stock                              0              0              0
  Common Stock                                25             22             18
  Retained Earnings                      -99,143        -79,220        -60,767
  Treasury Stock                               0              0              0
  Capital Surplus                        130,916        109,514         75,846
  Other Stockholder Equity                     0              0             -7
  Total Stockholder Equity                31,799         30,316         15,089
  Net Tangible Assets                     31,728         30,233         14,995


Quarterly Balance Sheets:                               All Numbers in Thousands
  Period Ending                Jun30,2011   Mar31,2011   Dec31,2010   Sep30,2010
Current Assets:
  Cash & Cash Equivalents          20,943       26,041       30,521       35,756
  Short Term Investments                0            0            0            0
  Net Receivables                       0            0            0            0
  Inventory                             0            0            0            0
  Other Current Assets                934          368          524          393
  Total Current Assets             21,877       26,409       31,044       36,149

  Long-Term Investments                 0            0            0            0
  Property, Plant & Equipt          1,827        1,937        2,074        2,235
  Goodwill                              0            0            0            0
  Intangible Assets                    65           68           71           74
  Accumulated Amortization              0            0            0            0
  Other Assets                        338          338          338          338
  Deferred LT Asset Charges            62           62           62           62
  Total Assets                     24,169       28,814       33,589       38,858

Current Liabilities:
  Accounts Payable                  1,237        1,637        1,656        1,776
  Current Portion LT Debt               0            0            0            0
  Other Current Liabilities            29           37           30           30
  Total Current Liabilities         1,266        1,674        1,686        1,806

  Long Term Debt                        0            0            0            0
  Other Liabilities                     0            0            0            0
  Deferred LT Liab. Charges           121          113          104           78
  Minority Interest                     0            0            0            0
  Negative Goodwill                     0            0            0            0
  Total Liabilities                 1,387        1,787        1,790        1,884

Stockholder Equity:
  Misc. Options, WarrantS               0            0            0            0
  Redeemable Perferred Stock            0            0            0            0
  Preferred Stock                       0            0            0            0
  Common Stock                         25           25           25           25
  Retained Earnings              -108,894     -104,085      -99,143      -93,818
  Treasury Stock                        0            0            0            0
  Capital Surplus                 131,651      131,087      130,916      130,767
  Other Stockholder Equity              0            0            0            0
  Total Stockholder Equity         22,781       27,028       31,799       36,974
  Net Tangible Assets              22,716       26,959       31,728       36,900


Annual Cash Flow:                                    All Numbers in Thousands
  Period Ending                      Dec31,2010     Dec31,2009     Dec31,2008

  Net Income                            -19,923         -4,942        -17,605
Operating Activites:
  Depreciation                              553            314          1,170
  Adjustments to Net Income                 718            847              0
  Changes in Accounts Recv'bls                0              0              0
  Changes in Liabilities                   -125            281            233
  Changes in Inventories                      0              0              0
  Changes in Other Op'ing Actv's              0           -292             -2
  Total Cash Flow fr Operations         -18,820        -17,303        -16,205

Investing Activities:
  Capital Expenditures                   -1,044         -1,251           -313
  Investments                                 0            397          1,334
  Other Cash Flows fr Investing               0              0              0
  Total Cash Flows fr Investing          -1,034           -854          1,021

Financing Acitivies:
  Dividends Paid                              0              0              0
  Sale or Purchase of Stock              20,702         32,760         11,057
  Net Borrowings                              0              0              0
  Other Cash Flows fr Financing               0              0              0
  Total Cash Flows fr Financing          20,702         32,760         11,057

  Effect of Exchange Rate Change              0              0              0
  Change in Cash & Cash Equiv.s             847         14,603         -4,127


Quarterly Cash Flow:                                   All Numbers in Thousands
  Period Ending                  Jun30,2011  Mar31,2011  Dec31,2010  Sep30,2010

  Net Income                         -4,810      -4,942      -5,325      -4,955

Operating Activites:
  Depreciation                          137         147         156         143
  Adjustments to Net Income             564         171          77         275
  Changes in Accounts Recv'bls            0           0           0           0
  Changes in Liabilities               -408         -12        -120         128
  Changes in Inventories                  0           0           0           0
  Changes in Other Oper'g Acts            0         164         -26        -120
  Total Cash Flow f Operations       -5,075      -4,472      -5,237      -4,529

Investing Activities:
  Capital Expenditures                  -23          -8           9        -416
  Investments                             0           0           0           0
  Other Cash Flows fr Investing           0           0           9           0
  Total Cash Flows fr Investing         -23          -8          18        -416

Financing Acitivies:
  Dividends Paid                          0           0           0           0
  Sale or Purchase of Stock               0           0         -22      15,386
  Net Borrowings                          0           0           0           0
  Other Cash Flows fr Financing           0           0           7           0
  Total Cash Flows fr Financing           0           0         -15      15,386

  Effect of Exchange Rate Chg             0           0           0           0
  Change in Cash & Cash Equiv.       -5,098      -4,480      -5,235      10,441


MELA   MELA Sciences, Inc.                [Indices near +3.0 or near zero,
                                          or < zero bear special attention.]
P/E Ratio Tests:
Current P/E Ratio < 28?    0.0000       P/E Ratio > 5?             0.0000
P/E Ratio Vs Growth Rate: -2.4800       Forward P/E Ratio < 28?    0.0000

Sales Tests:
Price/Sales Ratio < 2.3?   1.0000       Inventory/Sales < 5%?      1.0000
Sales < $1 billion?        1.0000       Operating Margin < 7.5%?   0.0000

Balance Sheet Tests:
Debt/Equity < 0.40?        1.0000       Long-Term Debt Service:    3.0000
LTD Being Reduced?         1.0000       Short-Term Debt Service:   3.0000
Current Ratio > 2?         3.0000       Working Capital >= 1.5?    0.1157
Leverage Ratio < 20%?      3.0000       Debt / Assets < 1?         1.0000
Quick Ratio > 1?           3.0000       Inventory Turnover > 1?    1.0000
Shares Out Decreasing?     1.2000       Market Cap.> 1.5 Billion?  3.0000
                                        Profit Margin > 7.5%?      0.0000
Income Tests:
Dividend Yield > 2.0%?     0.0000       EPS Annual Growth > 10%?  -0.4800
Enterprise Value/Revenue:  0.0000       EPS 5-yr Growth > 20%?     0.0000
Enterprise Value/EBITDA:  -0.8986       EPS Growth Consistent?     1.2000
EPS Qrtly Growth > 10%?    0.0000       Collection < 45 days?      1.0000
Rev. Qtrly Growth > 15%?   0.0000       Gross Pft/Cur. LTD < 1?    0.0000
EPS Annual Growth > 10%?  -0.4800       Borrowing Int. Rate< 6%?   1.0000

Stock Performance Tests:
Volatility > 25%?          3.0000       % Held by Insiders  < 5%?  1.0965
Beta > 1.25?               0.2400       % Held by Institut. < 50?  1.4245
50 Da MA > 200 Da MA?      0.2609       % Held by Institut. > 30?  1.1700
52-Wk Change vs. S&P 500:  0.1467       Short Ratio > 5?           0.9200
Price/Book Value < 3?     -2.3900       Short % of Float > 20?     0.7800
Return on Assets > 17%?   -2.8600       Average Volume > 100,000?  3.0000

Cash Flow Tests:
Oper. C.F. > Lever'd C.F: -1.4209       Positive Free Cash Flow?   0.0000
Positive Oper. Cash Flow?  0.0000       Price to C.F./sh. Ratio:  -0.8246
                                        Cash Flow / Assets >.10?  -3.0000

MELA    MELA Sciences, Inc.             Overall Zenith Index:      0.6163


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The `Index' is the `Degree' weighted for volatility.  Generally, the
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Results for Mela Sciences Inc.:
Symbol? MELA
Total Months Available:  71
       Months in Cycle?   4

Months Covered by Periods:  12

Period 1           Period 2          Period 3
   H1      L1        H2      L2        H3      L3
   8.32    2.51      3.97    2.22      6.20    1.75

RANGE   =   8.32  TO    1.75            Close =   6.21
CHANNEL =   3.97  TO    2.51           Degree =   2
Volatility =  23.51%                    Index =   4
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Recommendation

Decision Weighting Factors
FactorsWeighted Points
News + 1
Comparison - 1
Industry - 1
Bond Issue 0
Zenith Index - 1
Non-GAAP vs. GAAP Earnings < 1%+ 1
Cash Flow - 1
Ratios - 1
Market Grader 0
Intrinsic Value DCF - 1
Intrinsic Value DDM - 1
Stock Scout - 1
Projected Earnings - 1
Research Reports - 1
Analysts + 1
Executive Perquisites + 1
Insider Activity + 1
Institutional Activity - 1
Management Reporting + 1
Short Interest + 1
Sentiment + 1
Standard & Poor's 0
Moving Average + 1
Right Time Study + 1
Stock Fetcher - 1
Point & Figure + 1
Wall Street Analyzer - 1
Marketspace Chart + 1
Time Series Chart + 1
Neural Network + 1
Stock Options + 1
Ultimate Trading Systems 0
Total + 2
Place 4,615 shares of Mela Sciences, Inc. (MELA) on the Active List.