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DELAWARE
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94-3076866
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(State or other jurisdiction of
incorporation or organization)
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(IRS Employer
Identification No.)
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|
PART I. FINANCIAL INFORMATION
|
|||||
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Item 1.
|
Financial Statements
|
3 | |||
|
Balance Sheets as of June 30, 2014 (unaudited) and December 31, 2013
|
3 | ||||
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Statements of Operations (unaudited) for the three and six month periods ended June 30, 2014 and 2013
|
4 | ||||
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Statements of Comprehensive Income (Loss) (unaudited) for the three and six month periods ended June 30, 2014
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5 | ||||
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Statements of Cash Flows (unaudited) for the six month periods ended June 30, 2014 and 2013
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6 | ||||
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Notes to Financial Statements (unaudited)
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7 | ||||
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Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
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13 | |||
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Item 3.
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Quantitative and Qualitative Disclosures about Market Risk
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18 | |||
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Item 4.
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Controls and Procedures
|
18 | |||
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PART II.
|
OTHER INFORMATION
|
||||
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Item 6.
|
Exhibits
|
19 | |||
|
Signatures
|
20 | ||||
|
Index to Exhibits
|
21 | ||||
|
June 30,
|
December 31,
|
|||||||
|
2014
|
2013
|
|||||||
|
Assets
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
$
|
5,902,228
|
$
|
156,273
|
||||
|
Short term investments
|
6,012,309
|
––
|
||||||
|
Accounts receivable, trade, net of allowance for doubtful accounts of $1,100 at June 30, 2014 and December 31, 2013
|
566,540
|
1,009,316
|
||||||
|
Inventories
|
678,156
|
420,924
|
||||||
|
Prepaid expenses and other current assets
|
312,148
|
291,745
|
||||||
|
Total current assets
|
13,471,381
|
1,878,258
|
||||||
|
Property and equipment
|
||||||||
|
Leasehold improvements
|
1,121,362
|
1,121,362
|
||||||
|
Furniture and computer equipment
|
334,159
|
300,581
|
||||||
|
Manufacturing and other equipment
|
828,379
|
764,258
|
||||||
|
Subtotal
|
2,283,900
|
2,186,201
|
||||||
|
Less: Accumulated depreciation
|
(984,882
|
)
|
(862,157
|
)
|
||||
|
Net property and equipment
|
1,299,018
|
1,324,044
|
||||||
|
Long term deposits
|
36,166
|
36,166
|
||||||
|
Deferred financing costs, net
|
––
|
114,874
|
||||||
|
Total assets
|
$
|
14,806,565
|
$
|
3,353,342
|
||||
|
Liabilities and Shareholders’ Equity (Deficiency)
|
||||||||
|
Current liabilities
|
||||||||
|
Accounts payable
|
$
|
170,106
|
$
|
867,070
|
||||
|
Accrued expenses and other current liabilities
|
10,440
|
146,626
|
||||||
|
Accrued compensation
|
314,957
|
503,194
|
||||||
|
Deferred rent
|
117,501
|
111,250
|
||||||
|
Total current liabilities
|
613,004
|
1,628,140
|
||||||
|
Long term liabilities
|
||||||||
|
Promissory notes payable, related parties
|
––
|
10,603,127
|
||||||
|
Accrued interest, related parties
|
––
|
3,501,610
|
||||||
|
Deferred rent, long term
|
795,145
|
891,986
|
||||||
|
Total liabilities
|
1,408,149
|
16,624,863
|
||||||
|
Commitments and Contingencies (Note 10)
|
||||||||
|
Shareholders' equity (deficiency)
|
||||||||
|
Common stock, $0.001 par value; 150,000,000 shares authorized, 12,027,293 and 5,031,336 shares issued and outstanding at June 30, 2014 and December 31, 2013
|
12,027
|
5,030
|
||||||
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Additional paid-in capital
|
71,727,860
|
43,618,686
|
||||||
|
Accumulated other comprehensive income (loss)
|
(3,507
|
)
|
––
|
|||||
|
Accumulated deficit
|
(58,337,964
|
)
|
(56,895,237
|
)
|
||||
|
Total shareholders' equity (deficiency)
|
13,398,416
|
(13,271,521
|
)
|
|||||
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Total liabilities and shareholders' equity (deficiency)
|
$
|
14,806,565
|
$
|
3,353,342
|
||||
|
Three Months
|
Six Months
|
|||||||||||||||
|
Ended June 30,
|
Ended June 30,
|
|||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
|||||||||||||
|
Revenue
|
||||||||||||||||
|
Product sales
|
$ | 1,211,900 | $ | 2,330,018 | $ | 3,276,930 | $ | 3,880,863 | ||||||||
|
Licensing revenue
|
–– | –– | –– | 609,167 | ||||||||||||
|
Total revenue
|
1,211,900 | 2,330,018 | 3,276,930 | 4,490,030 | ||||||||||||
|
Cost of product sales
|
666,580 | 1,501,575 | 1,828,221 | 2,536,103 | ||||||||||||
|
Gross profit
|
545,320 | 828,443 | 1,448,709 | 1953927 | ||||||||||||
|
Operating expenses
|
||||||||||||||||
|
Research and development
|
192,778 | 94,908 | 360,065 | 200,876 | ||||||||||||
|
Sales and marketing
|
270,616 | 214,762 | 512,016 | 417,520 | ||||||||||||
|
General and administrative
|
969,799 | 601,617 | 1,833,542 | 1,226,044 | ||||||||||||
|
Total operating expenses
|
1,433,193 | 911,287 | 2,705,623 | 1,844,440 | ||||||||||||
|
Operating income (loss)
|
(887,873 | ) | (82,844 | ) | (1,256,914 | ) | 109,487 | |||||||||
|
Other income (expenses)
|
||||||||||||||||
|
Interest income
|
4,517 | –– | 4,517 | –– | ||||||||||||
|
Interest expense
|
–– | (185,555 | ) | (177,308 | ) | (371,110 | ) | |||||||||
|
Amortization of deferred financing costs
|
–– | (14,107 | ) | (13,022 | ) | (28,059 | ) | |||||||||
|
Total other income (expenses)
|
4,517 | (199,662 | ) | (185,813 | ) | (399,169 | ) | |||||||||
|
Net Loss
|
$ | (883,356 | ) | $ | (282,506 | ) | $ | (1,442,727 | ) | $ | (289,682 | ) | ||||
|
Basic and diluted net loss per common share
|
$ | (0.07 | ) | $ | (0.06 | ) | $ | (0.16 | ) | $ | (0.06 | ) | ||||
|
Basic and diluted weighted average common shares used to calculate net loss per common share
|
12,010,361 | 5,004,253 | 8,807,376 | 4,998,527 | ||||||||||||
|
Three Months
|
Six Months
|
|||||||||||||||
|
Ended June 30,
|
Ended June 30,
|
|||||||||||||||
|
2013
|
||||||||||||||||
|
2014
|
2014 | 2013 | ||||||||||||||
|
Net loss
|
$ | (883,356 | ) | $ | (282,506 | ) | $ | (1,442,727 | ) | $ | (289,682 | ) | ||||
|
Other comprehensive income (loss)
|
||||||||||||||||
|
Unrealized gain (loss) on available-for-sale investments
|
(3,507 | ) | –– | (3,507 | ) | –– | ||||||||||
|
Total other comprehensive loss
|
(3,507 | ) | –– | (3,507 | ) | –– | ||||||||||
|
Comprehensive income (loss)
|
$ | (886,863 | ) | $ | (282,506 | ) | $ | (1,446,234 | ) | $ | (289,682 | ) | ||||
|
Six Month Period Ended June 30,
|
||||||||
|
2014
|
2013
|
|||||||
|
Cash flows from operating activities
|
||||||||
|
Net loss
|
$
|
(1,442,727
|
)
|
$
|
(289,682
|
)
|
||
|
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
|
Depreciation
|
122,725
|
118,262
|
||||||
|
Stock-based compensation expense
|
109,176
|
87,553
|
||||||
|
Stock to be issued for services
|
150,000
|
––
|
||||||
|
Amortization of deferred financing costs
|
13,022
|
28,059
|
||||||
|
Lease incentives received from landlord, net of amortization of deferred rent related to lease incentives
|
(80,137
|
)
|
123,821
|
|||||
|
Accretion and amortization on available for sale investments
|
19,640
|
––
|
||||||
|
Change in operating assets and liabilities
|
||||||||
|
(Increase) Decrease in
|
||||||||
|
Accounts receivable, trade
|
442,776
|
(380,821
|
)
|
|||||
|
Inventories
|
(257,232
|
)
|
63,259
|
|||||
|
Prepaid expenses and other current assets
|
9,645
|
9,439
|
||||||
|
Increase (Decrease) in
|
||||||||
|
Accounts payable
|
(696,964
|
)
|
179,225
|
|||||
|
Accrued compensation and other current liabilities
|
(324,423
|
)
|
(101,371
|
)
|
||||
|
Accrued interest, related parties
|
177,308
|
371,110
|
||||||
|
Deferred rent
|
(10,453
|
)
|
(19,695
|
)
|
||||
|
Deferred revenue
|
––
|
(109,167
|
)
|
|||||
|
Net cash provided by (used in) operating activities
|
(1,767,644
|
)
|
79,992
|
|||||
|
Cash flows from investing activities
|
||||||||
|
Purchase of available-for-sale investments
|
(6,065,524
|
)
|
––
|
|||||
|
Purchase of property and equipment
|
(97,699
|
)
|
(225,723
|
)
|
||||
|
Net cash used in investing activities
|
(6,163,223
|
)
|
(225,723
|
)
|
||||
|
Cash flows from financing activities
|
||||||||
|
Proceeds from sale of common stock, net of expenses
|
13,596,230
|
––
|
||||||
|
Proceeds from exercise of common stock options
|
80,592
|
25,458
|
||||||
|
Net cash provided by financing activities
|
13,676,822
|
25,458
|
||||||
|
Net increase (decrease) in cash and cash equivalents
|
5,745,955
|
(120,273
|
)
|
|||||
|
Cash and cash equivalents - beginning of period
|
156,273
|
196,478
|
||||||
|
Cash and cash equivalents - end of period
|
$
|
5,902,228
|
$
|
76,205
|
||||
|
Non-cash financing activities
|
||||||||
|
Conversion of notes payable and related party accrued interest to equity,
net of unamortized deferred finance costs (See Note 1)
|
$
|
14,180,193
|
$
|
––
|
||||
|
1.
|
Organization and Significant Accounting Policies
|
|
2.
|
Accumulated Other Comprehensive Income (Loss)
|
|
Six Months Ended
June 30, 2014
|
||||
|
Beginning Balance
|
$
|
––
|
||
|
Unrealized Loss on Investments, Current Period
|
(3,507)
|
|||
|
Ending Balance
|
$
|
(3,507)
|
||
|
3.
|
Fair Value Measurement
|
|
Fair Value
as of
June 30,
2014
|
Quoted
Prices in
Active
Markets
(Level 1)
|
Significant
Other
Observable
Inputs
(Level 2)
|
||||||||||
|
Cash and cash equivalents
|
$
|
5,902,228
|
$
|
5,902,228
|
$
|
—
|
||||||
|
Available-for-sale investments
|
6,012,309
|
6,012,309
|
—
|
|||||||||
|
Assets measured at fair value at June 30, 2014
|
$
|
11,914,537
|
$
|
11,914,537
|
$
|
—
|
||||||
|
4.
|
Short Term Investments
|
|
June 30,
2014
|
||||
|
Cost
|
$
|
6,015,816
|
||
|
Unrealized Loss on Investments
|
(3,507
|
)
|
||
|
Fair Value
|
$
|
6,012,309
|
||
|
5.
|
Inventory
|
|
June 30,
2014
|
December 31,
2013
|
|||||||
|
Raw materials
|
$
|
359,610
|
$
|
334,031
|
||||
|
Work in progress
|
184,664
|
14,570
|
||||||
|
Finished goods
|
133,882
|
72,323
|
||||||
|
Total
|
$
|
678,156
|
$
|
420,924
|
||||
|
6.
|
Deferred Rent
|
|
June 30,
2014
|
December 31,
2013
|
|||||||
|
Landlord-funded leasehold improvements
|
$
|
1,021,015
|
$
|
1,047,026
|
||||
|
Less accumulated amortization
|
(187,189
|
)
|
(133,063
|
)
|
||||
|
Total
|
833,826
|
913,963
|
||||||
|
Straight line rent adjustment
|
78,820
|
89,273
|
||||||
|
Total deferred rent
|
$
|
912,646
|
$
|
1,003,236
|
||||
|
7.
|
Share-based Compensation
|
|
Six Month Period Ended
|
||||||||
|
June 30, 2014
|
||||||||
|
Wtd. Avg.
|
||||||||
|
Exercise
|
||||||||
|
Options
|
Price
|
|||||||
|
Outstanding at beginning of year
|
1,417,309
|
$
|
1.36
|
|||||
|
Granted
|
65,000
|
3.70
|
||||||
|
Exercised
|
(65,842
|
)
|
1.22
|
|||||
|
Forfeited
|
(49,002
|
)
|
1.52
|
|||||
|
Expired
|
––
|
––
|
||||||
|
Outstanding at June 30, 2014
|
1,367,465
|
$
|
1.38
|
|||||
|
Stock options exercisable at June 30, 2014
|
1,192,545
|
$
|
1.20
|
|||||
|
Three Month Period Ended
|
Six Month Period Ended
|
||||||||||||||||||||||||||
|
June 30,
|
June 30,
|
||||||||||||||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
||||||||||||||||||||||||
|
RRisk free interest rate
|
2.14%
|
––
|
2.14%
|
––
|
|||||||||||||||||||||||
|
Dividend yield
|
0.0%
|
––
|
0.0%
|
––
|
|||||||||||||||||||||||
|
Expected term (in years)
|
7
|
––
|
7
|
––
|
|||||||||||||||||||||||
|
Volatility
|
105.20%
|
––
|
105.20%
|
––
|
|||||||||||||||||||||||
|
Three Month Period Ended
|
Six Month Period Ended
|
|||||||||||||||
|
June 30,
|
June 30,
|
|||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
|||||||||||||
|
Research and development costs
|
$
|
9,351
|
$
|
6,954
|
$
|
17,486
|
$
|
13,908
|
||||||||
|
Sales and marketing costs
|
2,563
|
630
|
5,286
|
1,260
|
||||||||||||
|
General and administrative costs
|
39,111
|
1,378
|
65,276
|
49,314
|
||||||||||||
|
Cost of product sales
|
6,532
|
11,209
|
21,128
|
23,071
|
||||||||||||
|
Total
|
$
|
57,557
|
$
|
20,171
|
$
|
109,176
|
$
|
87,553
|
||||||||
|
8.
|
Warrants
|
|
Six Month Period Ended
|
||||||||
|
June 30, 2014
|
||||||||
|
Wtd. Avg.
|
||||||||
|
Exercise
|
||||||||
|
Warrants
|
Pric
e
|
|||||||
|
Outstanding at beginning of year
|
517,858
|
$
|
1.02
|
|||||
|
Granted
|
6,910,283
|
4.75
|
||||||
|
Exercised
|
––
|
––
|
||||||
|
Forfeited/Expired
|
––
|
––
|
||||||
|
Outstanding at June 30, 2014
|
7,428,141
|
$
|
4.49
|
|||||
|
9.
|
Net Loss per Common Share
|
|
Three Month Period Ended
|
Six Month Period Ended
|
|||||||||||||||
|
June 30,
|
June 30,
|
|||||||||||||||
|
2014
|
2013
|
2014
|
2013
|
|||||||||||||
|
Basic and diluted weighted average common stock shares outstanding
|
12,010,361
|
5,004,253
|
8,807,376
|
4,998,527
|
||||||||||||
|
Potentially dilutive securities excluded from loss per share computations:
|
||||||||||||||||
|
Common stock options
|
1,367,465
|
1,415,982
|
1,367,465
|
1,415,982
|
||||||||||||
|
Common stock purchase warrants
|
7,428,141
|
551,339
|
7,428,141
|
551,339
|
||||||||||||
|
10.
|
Commitments & Contingencies
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
●
|
Patented biopreservation media products for cells, tissues, and organs
|
|
●
|
Generic formulations of blood stem cell freezing media products
|
|
●
|
Custom product formulation and custom packaging services
|
|
●
|
Precision thermal packaging products
|
|
●
|
Contract aseptic manufacturing formulation, fill, and finish services of liquid media products
|
|
●
|
Total revenue decreased 48% for the second quarter of 2014 compared to the second quarter of 2013 and 41% from the first quarter of 2014, due to the cancellation of our contract manufacturing services agreement with an organ preservation company.
|
|
●
|
We announced the execution of a long-term contract manufacturing services agreement with Somahlution LLC, a Jupiter, Florida-based biotechnology company in July 2014. This agreement is expected to start generating revenue in the fourth quarter of 2014. We will manufacture DuraGraft
™, a tissue preservation solution for storage of harvested veins used in coronary artery bypass graft (CABG) and other vascular access surgeries.
|
|
●
|
Core product revenue in the second quarter of 2014 increased 14% over the second quarter of 2013, with increased sales to the regenerative medicine market, as well as strong sales to cell suppliers. Core product revenue was down 5% from the first quarter of 2014. Our core product revenue is subject to significant quarter-to-quarter fluctuations and can be concentrated in particular quarters. It is heavily dependent on the progress and timing of our customers’ clinical trials.
|
|
●
|
Net loss for the second quarter of 2014 increased to $883,356, compared to $282,506 in the second quarter of 2013 and $559,371 in the first quarter of 2014. The increase is the result of reduction in revenue from the cancellation of our contract manufacturing services agreement. We also reported higher research and development and selling and marketing expenses, with the ramp up in our efforts in both of those areas. General and administrative expenses also impacted net loss, with higher consulting fees for investor relations, higher personnel costs, including salaries and bonuses, and higher corporate costs, including corporate insurance, directors’ fees, legal fees and accounting fees.
|
|
●
|
Net cash used by operating activities was $1,767,644 in the first half of 2014 compared to cash provided by operations of $79,992 in the first half of 2013. The difference being primarily attributable to the reduction in revenue from the cancellation of our contract manufacturing services agreement
.
|
|
●
|
TxCell, a Nice, France-based biotechnology company developing innovative, personalized cell-based immunotherapies using antigen specific regulatory T cells (Ag-Tregs) for severe chronic inflammatory and autoimmune diseases, announced they adopted BioLife’s CryoStor clinical grade cell freezing media for use in their European phase IIb clinical trial of Ovasave® immunotherapy in refractory Crohn’s Disease, which is planned to start in the second half of 2014
.
|
|
●
|
We announced that we expect to launch biologistex, a new integrated service platform combining cloud-based information service and precision thermal shipping products for cells and tissues. We are finalizing the terms of this relationship and expect to be in beta trials with customers by the fourth quarter of this year.
|
|
●
|
We received the Frost & Sullivan 2014 Technology Innovation Leadership Award for Biopreservation Media, recognizing our position as a market leader.
|
|
Three Month Period Ended
|
||||||||||||
|
June 30,
|
||||||||||||
|
2014
|
2013
|
% Change
|
||||||||||
|
Revenue:
|
||||||||||||
|
Core product sales
|
$
|
1,076,780
|
$
|
941,568
|
14%
|
|||||||
|
Contract manufacturing services
|
135,120
|
1,388,450
|
(90)%
|
|||||||||
|
Total revenue
|
1,211,900
|
2,330,018
|
(48)%
|
|||||||||
|
Cost of sales
|
666,580
|
1,501,575
|
(56)%
|
|||||||||
|
Gross profit
|
$
|
545,320
|
$
|
828,443
|
(34)%
|
|||||||
|
Gross margin %
|
45.0%
|
35.6%
|
||||||||||
|
Six Month Period Ended
|
||||||||||||
|
June 30,
|
||||||||||||
|
2014
|
2013
|
% Change
|
||||||||||
|
Revenue:
|
||||||||||||
|
Core product sales
|
$
|
2,209,025
|
$
|
1,711,701
|
29%
|
|||||||
|
Contract manufacturing services
|
1,067,905
|
2,169,162
|
(51)%
|
|||||||||
|
Licensing revenue
|
––
|
609,167
|
(100)%
|
|||||||||
|
Total revenue
|
3,276,930
|
4,490,030
|
(27)%
|
|||||||||
|
Cost of sales
|
1,828,221
|
2,536,103
|
(28)%
|
|||||||||
|
Gross profit
|
$
|
1,448,709
|
$
|
1,953,927
|
(26)%
|
|||||||
|
Gross margin %
|
44.2%
|
43.5%
|
||||||||||
|
Three Month Period Ended
|
||||||||||||
|
June 30,
|
||||||||||||
|
2014
|
2013
|
% Change
|
||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
$
|
192,778
|
$
|
94,908
|
103%
|
|||||||
|
Sales and marketing
|
270,616
|
214,762
|
26%
|
|||||||||
|
General and administrative
|
969,799
|
601,617
|
61%
|
|||||||||
|
Operating Expenses
|
1,433,193
|
911,287
|
57%
|
|||||||||
|
% of revenue
|
118%
|
39%
|
||||||||||
|
Six Month Period Ended
|
||||||||||||
|
June 30,
|
||||||||||||
|
2014
|
2013
|
% Change
|
||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
$
|
360,065
|
$
|
200,876
|
79%
|
|||||||
|
Sales and marketing
|
512,016
|
417,520
|
23%
|
|||||||||
|
General and administrative
|
1,833,542
|
1,226,044
|
50%
|
|||||||||
|
Operating Expenses
|
2,705,623
|
1,844,440
|
47%
|
|||||||||
|
% of revenue
|
83%
|
41%
|
||||||||||
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
BIOLIFE SOLUTIONS, INC.
|
||||
|
Dated: August 7, 2014
|
/s/ Daphne Taylor
|
|||
|
Daphne Taylor
|
||||
|
Chief Financial Officer
(Duly authorized officer and principal
financial and accounting officer)
|
||||
|
Exhibit No.
|
Description
|
|
31.1
*
|
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
31.2
*
|
Certification pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
32.1
*
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
32.2
*
|
Certification pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
| *Filed herewith |
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|