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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.)
|
|
PART I. FINANCIAL INFORMATION
|
|||
| Item 1. Consolidated Financial Statements | |||
|
Consolidated Balance Sheets as of September 30, 2015 (unaudited) and December 31, 2014
|
3
|
||
|
Consolidated Statements of Operations (unaudited) for the three and nine month periods ended
September 30, 2015 and 2014
|
4
|
||
|
Consolidated Statements of Comprehensive Loss (unaudited) for the three and nine month
periods ended September 30, 2015 and 2014
|
5
|
||
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Consolidated Statements of Cash Flows (unaudited) for the nine month periods
ended September 30, 2015 and 2014
|
6
|
||
|
Notes to Consolidated Financial Statements (unaudited)
|
7
|
||
| Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations |
13
|
||
| Item 3. Quantitative and Qualitative Disclosures about Market Risk |
18
|
||
| Item 4. Controls and Procedures |
18
|
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| PART II. OTHER INFORMATION | |||
| Item 6. Exhibits |
18
|
||
|
Signatures
|
19
|
||
|
Index to Exhibits
|
20
|
||
|
September 30,
|
December 31,
|
|||||||
|
2015
|
2014
|
|||||||
|
Assets
|
||||||||
|
Current assets
|
||||||||
|
Cash and cash equivalents
|
$
|
2,351,540
|
$
|
2,538,758
|
||||
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Short term investments
|
2,902,105
|
7,399,636
|
||||||
|
Accounts receivable, trade, net of allowance for doubtful accounts of $0 at
September 30, 2015 and December 31, 2014
|
792,274
|
901,623
|
||||||
|
Inventories
|
1,783,383
|
965,224
|
||||||
|
Prepaid expenses and other current assets
|
453,789
|
360,521
|
||||||
|
Total current assets
|
8,283,091
|
12,165,762
|
||||||
|
Property and equipment
|
||||||||
|
Leasehold improvements
|
1,284,491
|
1,284,491
|
||||||
|
Furniture and computer equipment
|
535,768
|
476,788
|
||||||
|
Manufacturing and other equipment
|
1,017,262
|
972,386
|
||||||
|
Subtotal
|
2,837,521
|
2,733,665
|
||||||
|
Less: Accumulated depreciation
|
(1,333,608
|
)
|
(1,078,060
|
)
|
||||
|
Net property and equipment
|
1,503,913
|
1,655,605
|
||||||
|
Internal use software
|
1,187,022
|
––
|
||||||
|
Intangible asset
|
2,215,385
|
2,215,385
|
||||||
|
Long term deposits
|
36,166
|
36,166
|
||||||
|
Total assets
|
$
|
13,225,577
|
$
|
16,072,918
|
||||
|
Liabilities and Shareholders’ Equity
|
||||||||
|
Current liabilities
|
||||||||
|
Accounts payable
|
$
|
978,279
|
$
|
474,662
|
||||
|
Accrued expenses and other current liabilities
|
150,980
|
121,869
|
||||||
|
Accrued compensation
|
372,426
|
535,029
|
||||||
|
Deferred rent
|
130,216
|
130,216
|
||||||
|
Total current liabilities
|
1,631,901
|
1,261,776
|
||||||
|
Long term liabilities
|
||||||||
|
Deferred rent, long term
|
809,275
|
874,825
|
||||||
|
Total liabilities
|
2,441,176
|
2,136,601
|
||||||
|
Commitments and contingencies (Note 10)
|
||||||||
|
Shareholders' equity
|
||||||||
|
Common stock, $0.001 par value; 150,000,000 shares authorized, 12,172,715 and 12,084,859 shares issued and outstanding at September 30, 2015 and December 31, 2014
|
12,172
|
12,084
|
||||||
|
Additional paid-in capital
|
72,347,856
|
71,911,328
|
||||||
|
Accumulated other comprehensive loss
|
(601
|
)
|
(6,448
|
)
|
||||
|
Accumulated deficit
|
(63,207,536
|
)
|
(60,112,987
|
)
|
||||
|
Total BioLife Solutions, Inc. shareholders' equity
|
9,151,891
|
11,803,977
|
||||||
|
Total non-controlling interest equity
|
1,632,510
|
2,132,340
|
||||||
|
Total shareholders' equity
|
10,784,401
|
13,936,317
|
||||||
|
Total liabilities and shareholders' equity
|
$
|
13,225,577
|
$
|
16,072,918
|
||||
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Product sales
|
$ | 1,631,926 | $ | 1,243,372 | $ | 4,629,407 | $ | 4,520,302 | ||||||||
|
Cost of product sales
|
658,542 | 654,978 | 1,954,752 | 2,483,199 | ||||||||||||
|
Gross profit
|
973,384 | 588,394 | 2,674,655 | 2,037,103 | ||||||||||||
|
Operating expenses
|
||||||||||||||||
|
Research and development
|
329,527 | 153,328 | 953,026 | 513,393 | ||||||||||||
|
Sales and marketing
|
677,033 | 298,263 | 1,819,778 | 810,279 | ||||||||||||
|
General and administrative
|
1,263,272 | 1,011,316 | 3,514,678 | 2,844,858 | ||||||||||||
|
Total operating expenses
|
2,269,832 | 1,462,907 | 6,287,482 | 4,168,530 | ||||||||||||
|
Operating loss
|
(1,296,448 | ) | (874,513 | ) | (3,612,827 | ) | (2,131,427 | ) | ||||||||
|
Other income (expenses)
|
||||||||||||||||
|
Gain on disposal of property and equipment
|
–– | 4,400 | –– | 4,400 | ||||||||||||
|
Interest income
|
4,729 | 7,658 | 18,448 | 12,175 | ||||||||||||
|
Interest expense
|
–– | –– | –– | (177,308 | ) | |||||||||||
|
Amortization of deferred financing costs
|
–– | –– | –– | (13,022 | ) | |||||||||||
|
Total other income (expenses)
|
4,729 | 12,058 | 18,448 | (173,755 | ) | |||||||||||
|
Net loss
|
(1,291,719 | ) | (862,455 | ) | (3,594,379 | ) | (2,305,182 | ) | ||||||||
|
Net loss attributable to non-controlling interest
|
223,031 | –– | 499,830 | –– | ||||||||||||
|
Net loss attributable to BioLife Solutions, Inc.
|
$ | (1,068,688 | ) | $ | (862,455 | ) | $ | (3,094,549 | ) | $ | (2,305,182 | ) | ||||
|
Basic and diluted net loss per common share
attributable to BioLife Solutions, Inc.
|
$ | (0.09 | ) | $ | (0.07 | ) | $ | (0.26 | ) | $ | (0.23 | ) | ||||
|
Basic and diluted weighted average common
shares used to calculate net loss per common
share
|
12,157,575 | 12,042,739 | 12,134,474 | 9,987,682 |
|
Three Months
Ended September 30,
|
Nine Months
Ended September 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Net loss
|
$ | (1,291,719 | ) | $ | (862,455 | ) | $ | (3,594,379 | ) | $ | (2,305,182 | ) | ||||
|
Other comprehensive income (loss)
|
||||||||||||||||
|
Unrealized gain (loss) on available-for-sale
investments
|
789 | (3,099 | ) | 5,847 | (6,606 | ) | ||||||||||
|
Total other comprehensive income (loss)
|
789 | (3,099 | ) | 5,847 | (6,606 | ) | ||||||||||
|
Comprehensive loss attributable to non-
controlling interest
|
223,031 | –– | 499,830 | –– | ||||||||||||
|
Comprehensive loss attributable to BioLife Solutions, Inc.
|
$ | (1,067,899 | ) | $ | (865,554 | ) | $ | (3,088,702 | ) | $ | (2,311,788 | ) | ||||
|
Nine Month Period Ended
September 30,
|
||||||||
|
2015
|
2014
|
|||||||
|
Cash flows from operating activities
|
||||||||
|
Net loss
|
$
|
(3,594,379
|
)
|
$
|
(2,305,182
|
)
|
||
|
Adjustments to reconcile net loss to net cash used in operating activities
|
||||||||
|
Depreciation
|
255,548
|
186,105
|
||||||
|
Gain on disposal of property and equipment
|
––
|
(4,400
|
)
|
|||||
|
Stock-based compensation expense
|
336,630
|
183,501
|
||||||
|
Stock issued for services
|
––
|
210,000
|
||||||
|
Amortization of deferred financing costs
|
––
|
13,022
|
||||||
|
Amortization of deferred rent related to lease incentives
|
(95,250
|
)
|
(121,103
|
)
|
||||
|
Accretion and amortization on available for sale investments
|
81,210
|
53,198
|
||||||
|
Change in operating assets and liabilities
|
||||||||
|
(Increase) Decrease in
|
||||||||
|
Accounts receivable, trade
|
109,349
|
234,240
|
||||||
|
Inventories
|
(818,159
|
)
|
(296,700
|
)
|
||||
|
Prepaid expenses and other current assets
|
(86,405
|
)
|
16,638
|
|||||
|
Increase (Decrease) in
|
||||||||
|
Accounts payable
|
253,647
|
(698,232
|
)
|
|||||
|
Accrued compensation and other current liabilities
|
(175,482
|
)
|
(185,928
|
)
|
||||
|
Accrued interest, related parties
|
––
|
177,308
|
||||||
|
Deferred rent
|
29,700
|
(18,007
|
)
|
|||||
|
Deferred revenue
|
––
|
90,000
|
||||||
|
Net cash used in operating activities
|
(3,703,591
|
)
|
(2,465,540
|
)
|
||||
|
Cash flows from investing activities
|
||||||||
|
Sales of available-for-sale investments
|
5,825,000
|
102,376
|
||||||
|
Purchases of available-for-sale investments
|
(1,409,695
|
)
|
(7,952,119
|
)
|
||||
|
Proceeds from the sale of property and equipment
|
––
|
4,400
|
||||||
|
Costs associated with internal use software development
|
(895,062
|
)
|
––
|
|||||
|
Purchase of property and equipment
|
(103,856
|
)
|
(247,155
|
)
|
||||
|
Net cash provided by (used in) investing activities
|
3,416,387
|
(8,092,498
|
)
|
|||||
|
Cash flows from financing activities
|
||||||||
|
Proceeds from sale of common stock, net of expenses
|
––
|
13,596,230
|
||||||
|
Proceeds from exercise of common stock options
|
99,986
|
80,592
|
||||||
|
Net cash provided by financing activities
|
99,986
|
13,676,822
|
||||||
|
Net increase (decrease) in cash and cash equivalents
|
(187,218
|
)
|
3,118,784
|
|||||
|
Cash and cash equivalents - beginning of period
|
2,538,758
|
156,273
|
||||||
|
Cash and cash equivalents - end of period
|
$
|
2,351,540
|
$
|
3,275,057
|
||||
|
Non-cash investing activities
|
||||||||
|
Costs incurred for capitalized internal use software not paid as of quarter
end (amounts are included in liabilities)
|
$
|
291,960
|
$
|
––
|
||||
|
Non-cash financing activities
|
||||||||
|
Conversion of notes payable and related party accrued interest to equity, net of unamortized deferred finance costs
|
$
|
––
|
$
|
14,180,193
|
||||
|
1.
|
Organization and Significant Accounting Policies
|
|
2.
|
Accumulated Other Comprehensive Loss
|
|
Nine Months Ended
September 30, 2015
|
||||
|
Unrealized Loss on Investments, Beginning Balance
|
$
|
(6,448
|
)
|
|
|
Unrealized Gain on Investments, Current Period
|
5,847
|
|||
|
Unrealized Loss on Investments, Ending Balance
|
$
|
(601
|
)
|
|
|
3.
|
Fair Value Measurement
|
|
As of September 30, 2015
|
Level 1
|
Level 2
|
Total
|
|||||||||
|
Bank deposits
|
$ | 345,085 | $ | — | $ | 345,085 | ||||||
|
Money market funds
|
2,006,455 | — | 2,006,455 | |||||||||
|
Cash and cash equivalents
|
2,351,540 | — | 2,351,540 | |||||||||
|
Corporate debt securities
|
2,902,105 | — | 2,902,105 | |||||||||
|
Total
|
$ | 5,253,645 | $ | — | $ | 5,253,645 | ||||||
|
As of December 31, 2014
|
Level 1
|
Level 2
|
Total
|
|||||||||
|
Bank deposits
|
$ | 972,891 | $ | — | $ | 972,891 | ||||||
|
Money market funds
|
1,565,867 | — | 1,565,867 | |||||||||
|
Cash and cash equivalents
|
2,538,758 | — | 2,538,758 | |||||||||
|
Corporate debt securities
|
6,799,702 | — | 6,799,702 | |||||||||
|
Commercial paper
|
599,934 | — | 599,934 | |||||||||
|
Short term investments
|
7,399,636 | — | 7,399,636 | |||||||||
|
Total
|
$ | 9,938,394 | $ | — | $ | 9,938,394 | ||||||
|
4.
|
Short Term Investments
|
|
Amortized Cost
|
Gross Unrealized Gains
|
Gross Unrealized Losses
|
Fair Value
|
|||||||||||||
|
Corporate debt securities
|
$ | 2,902,706 | $ | — | $ | (601 | ) | $ | 2,902,105 | |||||||
|
Amortized Cost
|
Gross Unrealized Gains
|
Gross Unrealized Losses
|
Fair Value
|
|||||||||||||
|
Corporate debt securities
|
$ | 6,806,150 | $ | — | $ | (6,448 | ) | $ | 6,799,702 | |||||||
|
Commercial paper
|
599,934 | — | — | 599,934 | ||||||||||||
|
Total marketable securities
|
$ | 7,406,084 | $ | — | $ | (6,448 | ) | $ | 7,399,636 | |||||||
|
5.
|
Inventory
|
|
September 30, 2015
|
December 31, 2014
|
|||||||
|
Raw materials
|
$
|
351,783
|
$
|
362,656
|
||||
|
Work in progress
|
552,702
|
79,012
|
||||||
|
Finished goods
|
878,898
|
523,556
|
||||||
|
Total
|
$
|
1,783,383
|
$
|
965,224
|
||||
|
6.
|
Deferred Rent
|
|
September 30, 2015
|
December 31, 2014
|
|||||||
|
Landlord-funded leasehold improvements
|
$
|
1,124,790
|
$
|
1,124,790
|
||||
|
Less accumulated amortization
|
(343,781
|
)
|
(248,531
|
)
|
||||
|
Total
|
781,009
|
876,259
|
||||||
|
Straight line rent adjustment
|
158,482
|
128,782
|
||||||
|
Total deferred rent
|
$
|
939,491
|
$
|
1,005,041
|
||||
|
7.
|
Share-based Compensation
|
|
Nine Month Period Ended
|
||||||||
|
September 30, 2015
|
||||||||
|
Wtd. Avg.
|
||||||||
|
Exercise
|
||||||||
|
Options
|
Price
|
|||||||
|
Outstanding at beginning of year
|
1,390,770
|
$
|
1.50
|
|||||
|
Granted
|
1,290,881
|
$
|
2.06
|
|||||
|
Exercised
|
(87,856
|
)
|
$
|
1.14
|
||||
|
Forfeited
|
(3,438
|
)
|
$
|
3.77
|
||||
|
Outstanding at September 30, 2015
|
2,590,357
|
$
|
1.79
|
|||||
|
Stock options exercisable at September 30, 2015
|
1,215,230
|
$
|
1.41
|
|||||
|
Three Month Period Ended
|
Nine Month Period Ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Risk free interest rate
|
1.77%
|
1.93%
|
1.77%
|
2.02%
|
||||||||||||
|
Dividend yield
|
0.0%
|
0.0%
|
0.0%
|
0.0%
|
||||||||||||
|
Expected term (in years)
|
7
|
7
|
7
|
7
|
||||||||||||
|
Volatility
|
105%
|
105%
|
105%
|
105%
|
||||||||||||
|
Three Month Period Ended
|
Nine Month Period Ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Research and development costs
|
$
|
26,751
|
$
|
1,064
|
$
|
53,109
|
$
|
18,550
|
||||||||
|
Sales and marketing costs
|
26,746
|
7,624
|
51,771
|
12,910
|
||||||||||||
|
General and administrative costs
|
93,955
|
46,671
|
159,405
|
111,947
|
||||||||||||
|
Cost of product sales
|
30,807
|
18,966
|
72,345
|
40,094
|
||||||||||||
|
Total
|
$
|
178,259
|
$
|
74,325
|
$
|
336,630
|
$
|
183,501
|
||||||||
|
8.
|
Warrants
|
|
9.
|
Net Loss per Common Share
|
|
Three Month Period Ended
|
Nine Month Period Ended
|
|||||||||||||||
|
September 30,
|
September 30,
|
|||||||||||||||
|
2015
|
2014
|
2015
|
2014
|
|||||||||||||
|
Basic and diluted weighted average common stock shares outstanding
|
12,157,575
|
12,042,739
|
12,134,474
|
9,987,682
|
||||||||||||
|
Potentially dilutive securities excluded from loss per share computations:
|
||||||||||||||||
|
Common stock options
|
2,590,357
|
1,384,341
|
2,590,357
|
1,384,341
|
||||||||||||
|
Common stock purchase warrants
|
7,428,141
|
7,428,141
|
7,428,141
|
7,428,141
|
||||||||||||
|
10.
|
Commitments & Contingencies
|
|
Item 2.
|
Management’s Discussion and Analysis of Financial Condition and Results of Operations
|
|
●
|
anticipated product developments, regulatory filings and related requirements;
|
|
●
|
timing and amount of future contractual payments, product revenue and operating expenses;
|
|
●
|
market acceptance of our products and the estimated potential size of these markets; and
|
|
●
|
projections regarding liquidity, capital requirements and the terms of any financing agreements.
|
|
●
|
Biopreservation media products revenue was $1.6 million in the third quarter of 2015, an increase of 31% over the same period in 2014. For the first nine months of 2015, biopreservation media product revenue increased 32% as compared to last year. Third quarter revenue growth drivers include 38% higher direct sales to our regenerative medicine customers compared to the same period in 2014 and higher sales through our distribution network. Sales to our hair transplantation customers also grew over 100% compared to the same period in 2014.
|
|
●
|
Gross margin in the third quarter of 2015 was 60%, compared to 47% in the third quarter of 2014. For the first nine months of 2015, gross margin was 58%, compared to 45% in the first nine months of 2014. The improvement over 2014 reflects higher sales of biopreservation media products, with improved utilization of our manufacturing facility and lower overhead costs allocated per unit. In addition, the nine months ended September 30, 2015 included $0.1 million and the nine months ended September 30, 2014 included $1.1 million of low margin contract-manufacturing revenue.
|
|
●
|
For the three months ended September 30, 2015, consolidated net loss was $1.3 million and net loss attributable to BioLife was $1.1 million. This is compared to a consolidated net loss of $0.9 million in the third quarter of 2014. For the nine months ended September 30, 2015, consolidated net loss was $3.6 million and net loss attributable to BioLife was $3.1 million, compared to consolidated net loss of $2.3 million in the nine months ended September 30, 2014. The increase in the loss is primarily the result of increased headcount and spending related to the development and launch activities of our biologistex joint venture.
|
|
●
|
biologistex Commercial Launch: During the quarter, we commercially launched the biologistex cold chain management app and began shipping evo™ Smart Shippers to customers to support their validation processes
.
|
|
●
|
Product Innovation: We launched the new product, BloodStor 27 NaCl Freeze Media, targeting end user cryopreservation applications including freezing of platelets for clinical administration. In the U.S. alone, over 2 million doses of fresh platelets are administered annually. Frozen storage of therapeutic platelets could improve logistics in caring for hemodynamically unstable patients, in situations where fresh platelets are unable to be collected or administered following collection.
|
|
●
|
Customer Adoption: Management believes that BioLife products are now embedded in over 200 pre-clinical validation projects and human clinical trials for new cell and tissue-based regenerative medicine products and therapies. A significant number involve CAR-T cells and other types of T cells and mesenchymal stem cells targeting blood cancers, solid tumors and other leading causes of death and disability. UK-based TC Biopharm Ltd, a developer of anti-cancer immunotherapies, announced that it has incorporated our CryoStor clinical and commercial grade freeze media in its manufacturing and clinical delivery processes of ImmuniCell, a novel T cell based immunotherapy targeting various cancers.
|
|
Three Month Period Ended
|
||||||||||||
|
September 30,
|
||||||||||||
|
2015
|
2014
|
% Change
|
||||||||||
|
Revenue:
|
||||||||||||
|
Biopreservation media product sales
|
$1,631,926
|
$1,243,372
|
31%
|
|||||||||
|
Cost of sales
|
658,542
|
654,978
|
1%
|
|||||||||
|
Gross profit
|
973,384
|
588,394
|
65%
|
|||||||||
|
Gross margin %
|
60%
|
47%
|
||||||||||
|
Nine Month Period Ended
|
||||||||||||
|
September 30,
|
||||||||||||
|
2015
|
2014
|
% Change
|
||||||||||
|
Revenue:
|
||||||||||||
|
Biopreservation media product sales
|
$
|
4,542,526
|
$
|
3,452,397
|
32%
|
|||||||
|
Contract manufacturing services
|
86,881
|
1,067,905
|
(92)%
|
|||||||||
|
Total revenue
|
4,629,407
|
4,520,302
|
2%
|
|||||||||
|
Cost of sales
|
1,954,752
|
2,483,199
|
(21)%
|
|||||||||
|
Gross profit
|
2,674,655
|
2,037,103
|
31%
|
|||||||||
|
Gross margin %
|
58%
|
45%
|
||||||||||
|
Three Month Period Ended
|
||||||||||||
|
September 30,
|
||||||||||||
|
2015
|
2014
|
% Change
|
||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
$
|
329,527
|
$
|
153,328
|
115%
|
|||||||
|
Sales and marketing
|
677,033
|
298,263
|
127%
|
|||||||||
|
General and administrative
|
1,263,272
|
1,011,316
|
25%
|
|||||||||
|
Operating Expenses
|
2,269,832
|
1,462,907
|
55%
|
|||||||||
|
% of revenue
|
139%
|
118%
|
||||||||||
|
Nine Month Period Ended
|
||||||||||||
|
September 30,
|
||||||||||||
|
2015
|
2014
|
% Change
|
||||||||||
|
Operating Expenses:
|
||||||||||||
|
Research and development
|
$
|
953,026
|
$
|
513,393
|
86%
|
|||||||
|
Sales and marketing
|
1,819,778
|
810,279
|
125%
|
|||||||||
|
General and administrative
|
3,514,678
|
2,844,858
|
24%
|
|||||||||
|
Operating Expenses
|
6,287,482
|
4,168,530
|
51%
|
|||||||||
|
% of revenue
|
136%
|
92%
|
||||||||||
|
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
|
BIOLIFE SOLUTIONS, INC.
|
|||
|
Dated: November 12, 2015
|
By:
|
/s/ Daphne Taylor | |
|
Daphne Taylor
|
|||
|
Chief Financial 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 |
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 |
|---|