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|
VENAXIS, INC.
|
|
|
(Exact name of registrant as specified in its charter)
|
|
|
Colorado
|
84-1553387
|
|
(State or other jurisdiction of
incorporation or organization)
|
(I.R.S. Employer Identification No.)
|
|
1775 38
th
Street, Boulder, Colorado 80301
|
|
(Address of principal executive offices) (Zip Code)
|
|
(303) 545-5550
|
|
(Registrant's telephone number, including area code)
|
|
Page
|
||||||
|
PART I - Financial Information
|
||||||
|
Item 1.
|
Condensed Consolidated Financial Statements
|
|||||
|
Consolidated Balance Sheets as of September 30, 2016 (unaudited) and December 31, 2015
|
3
|
|||||
|
Consolidated Statements of Operations for the Three and Nine Months Ended September 30, 2016 and 2015 (unaudited)
|
4
|
|||||
|
Consolidated Statements of Cash Flows for the Nine Months Ended September 30, 2016 and 2015 (unaudited)
|
5
|
|||||
|
Notes to Condensed Consolidated Financial Statements (unaudited)
|
6
|
|||||
|
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
18
|
||||
|
Item 3.
|
Quantitative and Qualitative Disclosures About Market Risk
|
23
|
||||
|
Item 4.
|
Controls and Procedures
|
24
|
||||
|
PART II - Other Information
|
||||||
|
Item 1.
|
Legal Proceedings
|
25
|
||||
|
Item 1A.
|
Risk Factors
|
25
|
||||
|
Item 6.
|
Exhibits
|
28
|
||||
|
Signatures
|
29
|
|||||
|
September 30,
2016
|
December 31,
2015
|
|||||||
|
(Unaudited)
|
||||||||
|
ASSETS
|
||||||||
|
Current assets (Note 1):
|
||||||||
|
Cash and cash equivalents
|
$
|
2,447,320
|
$
|
2,012,283
|
||||
|
Short-term investments
|
12,416,087
|
14,147,991
|
||||||
|
Accounts receivable, net
|
21,508
|
-
|
||||||
|
Inventories (Note 2)
|
412,106
|
-
|
||||||
|
Prepaid expenses and other current assets
|
322,867
|
251,778
|
||||||
|
Total current assets
|
15,619,888
|
16,412,052
|
||||||
|
Property and equipment, net (Note 3)
|
95,387
|
1,954,496
|
||||||
|
Intangible rights acquired (Note 2)
|
2,291,966
|
-
|
||||||
|
Long-term investments (Note 1)
|
-
|
972,000
|
||||||
|
Other long term assets, net (Notes 1 and 4)
|
1,315,556
|
1,523,649
|
||||||
|
Total assets
|
$
|
19,322,797
|
$
|
20,862,197
|
||||
|
LIABILITIES AND STOCKHOLDERS' EQUITY
|
||||||||
|
Current liabilities:
|
||||||||
|
Accounts payable
|
$
|
297,044
|
$
|
701,064
|
||||
|
Accrued compensation
|
329,098
|
449,873
|
||||||
|
Accrued expenses
|
233,506
|
241,882
|
||||||
|
Notes and other obligations, current portion (Note 5)
|
222,135
|
301,250
|
||||||
|
Deferred revenue, current portion (Note 8)
|
96,698
|
96,698
|
||||||
|
Total current liabilities
|
1,178,481
|
1,790,767
|
||||||
|
Notes and other obligations, less current portion (Note 5)
|
-
|
1,838,779
|
||||||
|
Deferred revenue, less current portion (Note 8)
|
1,089,490
|
1,162,015
|
||||||
|
Total liabilities
|
2,267,971
|
4,791,561
|
||||||
|
Commitments and contingencies (Notes 8 and 9)
|
||||||||
|
Stockholders' equity (Notes 2, 6 and 7):
|
||||||||
|
Venaxis' stockholders' equity:
|
||||||||
|
Common stock, no par value, 60,000,000 shares authorized; 4,503,971 and
|
||||||||
|
3,876,961 shares issued and outstanding
|
124,598,545
|
121,653,075
|
||||||
|
Accumulated deficit
|
(107,568,735
|
)
|
(105,582,439
|
)
|
||||
|
Total Venaxis stockholders' equity
|
17,029,810
|
16,070,636
|
||||||
|
Non-controlling interest
|
25,016
|
-
|
||||||
|
Total equity
|
17,054,826
|
16,070,636
|
||||||
|
Total liabilities and stockholders' equity
|
$
|
19,322,797
|
$
|
20,862,197
|
||||
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
Sales (Note 1)
|
$
|
1,923
|
$
|
57,089
|
$
|
1,923
|
$
|
92,894
|
||||||||
|
Cost of sales
|
1,567
|
14,533
|
1,567
|
26,636
|
||||||||||||
|
Gross profit
|
356
|
42,556
|
356
|
66,258
|
||||||||||||
|
Other revenue – fee (Note 8)
|
24,175
|
24,175
|
72,524
|
72,524
|
||||||||||||
|
Operating expenses:
|
||||||||||||||||
|
Selling, general and administrative
|
1,715,475
|
1,231,101
|
3,568,436
|
4,249,560
|
||||||||||||
|
Research and development
|
54,458
|
426,263
|
500,129
|
1,686,413
|
||||||||||||
|
Total operating expenses
|
1,769,933
|
1,657,364
|
4,068,565
|
5,935,973
|
||||||||||||
|
Operating loss
|
(1,745,402
|
)
|
(1,590,633
|
)
|
(3,995,685
|
)
|
(5,797,191
|
)
|
||||||||
|
Other income (expense):
|
||||||||||||||||
|
Gain on sale of property and equipment (Note 3)
|
13,062
|
-
|
1,933,335
|
-
|
||||||||||||
|
Interest expense
|
(2,384
|
)
|
(25,393
|
)
|
(28,130
|
)
|
(74,652
|
)
|
||||||||
|
Investment income
|
23,639
|
32,942
|
103,031
|
69,151
|
||||||||||||
|
Total other income (expense)
|
34,317
|
7,549
|
2,008,236
|
(5,501
|
)
|
|||||||||||
|
Net loss
|
(1,711,085
|
)
|
(1,583,084
|
)
|
(1,987,449
|
)
|
(5,802,692
|
)
|
||||||||
|
Net loss attributable to non-controlling interest
|
1,153
|
-
|
1,153
|
-
|
||||||||||||
|
Net loss attributable to Venaxis, Inc.
|
$
|
(1,709,932
|
)
|
$
|
(1,583,084
|
)
|
$
|
(1,986,296
|
)
|
$
|
(5,802,692
|
)
|
||||
|
Basic and diluted net loss per share (Note 1)
|
$
|
(0.43
|
)
|
$
|
(0.41
|
)
|
$
|
(0.51
|
)
|
$
|
(1.50
|
)
|
||||
|
Basic and diluted weighted average number of shares outstanding (Note 1)
|
3,999,637
|
3,876,961
|
3,918,151
|
3,876,961
|
||||||||||||
|
2016
|
2015
|
|||||||
|
Cash flows from operating activities:
|
||||||||
|
Net loss
|
$
|
(1,987,449
|
)
|
$
|
(5,802,692
|
)
|
||
|
Adjustments to reconcile net loss to
|
||||||||
|
net cash used in operating activities:
|
||||||||
|
Stock-based compensation for services
|
368,459
|
1,019,067
|
||||||
|
Depreciation and amortization
|
96,997
|
194,438
|
||||||
|
Amortization of license fees
|
(72,524
|
)
|
(72,524
|
)
|
||||
|
Other non-cash charges
|
200,385
|
4,647
|
||||||
|
Gain on sale of property and equipment
|
(1,933,335
|
)
|
-
|
|||||
|
Change in (net of BiOptix business acquisition):
|
||||||||
|
Accounts receivable
|
(602
|
)
|
(59,677
|
)
|
||||
|
Prepaid expenses and other current assets
|
224,246
|
236,822
|
||||||
|
Accounts payable
|
(521,600
|
)
|
(225,316
|
)
|
||||
|
Accrued compensation
|
(120,775
|
)
|
(430,207
|
)
|
||||
|
Accrued expenses
|
(94,869
|
)
|
(80,995
|
)
|
||||
|
Net cash (used in) operating activities
|
(3,841,067
|
)
|
(5,216,437
|
)
|
||||
|
Cash flows from investing activities:
|
||||||||
|
Purchases of short-term investments
|
(13,818,949
|
)
|
(21,208,206
|
)
|
||||
|
Sales of short-term investments
|
16,522,853
|
26,505,093
|
||||||
|
Proceeds from sale of property and equipment
|
1,799,143
|
-
|
||||||
|
Purchases of patent and trademark application costs
|
(14,378
|
)
|
(59,914
|
)
|
||||
|
Cash acquired in purchase of BiOptix
|
16,673
|
-
|
||||||
|
Net cash provided by investing activities
|
4,505,342
|
5,236,973
|
||||||
|
Cash flows from financing activities:
|
||||||||
|
Repayment of notes payable and other obligations
|
(229,238
|
)
|
(330,139
|
)
|
||||
|
Net cash (used in) financing activities
|
(229,238
|
)
|
(330,139
|
)
|
||||
|
Net change in cash and cash equivalents
|
435,037
|
(309,603
|
)
|
|||||
|
Cash and cash equivalents at beginning of period
|
2,012,283
|
3,539,911
|
||||||
|
Cash and cash equivalents at end of period
|
$
|
2,447,320
|
$
|
3,230,308
|
||||
|
Supplemental disclosure of cash flow information:
|
||||||||
|
Cash paid during the period for interest
|
$
|
33,331
|
$
|
74,936
|
||||
|
Supplemental disclosure of investing information:
|
||||||||
|
Liability payoffs upon property sale
|
$
|
2,064,758
|
$
|
-
|
||||
|
Value of Common Shares issued for BiOptix purchase
|
$
|
2,577,011
|
$
|
-
|
||||
|
·
|
focusing on the BiOptix business plan to advance on commercial and development activities to increase the value of the operation;
|
|
·
|
exploring prospective partnering or licensing opportunities with appreciable opportunities and technologies;
|
|
·
|
continuing to evaluate options to monetize, partner or license the Company's appendicitis product portfolio; and
|
|
·
|
continuing to implement cost control initiatives to conserve cash.
|
|
Cash and cash equivalents
|
$
|
17,000
|
||
|
Accounts receivable
|
21,000
|
|||
|
Inventory
|
413,000
|
|||
|
Prepaid and other assets
|
52,000
|
|||
|
Equipment
|
93,000
|
|||
|
Intangible rights acquired
|
2,312,000
|
|||
|
Accounts payable
|
(118,000
|
)
|
||
|
Accrued and other liabilities
|
(187,000
|
)
|
||
|
Non-controlling interest
|
(26,000
|
)
|
||
|
Purchase price
|
$
|
2,577,000
|
|
|
Year to Date period ended September 30,
|
|||||||
|
|
2016
|
2015
|
||||||
|
Total revenues
|
$
|
191,577
|
639,944
|
|||||
|
Net (loss) attributable to Venaxis
|
$
|
(4,527,483
|
)
|
$
|
(8,380,348
|
)
|
||
|
Basic and diluted loss per share
|
$
|
(1.01
|
)
|
$
|
(1.86
|
)
|
||
|
September 30,
2016
(Unaudited)
|
December 31,
2015
|
|||||||
|
Land and improvements
|
$
|
-
|
$
|
1,107,508
|
||||
|
Building
|
-
|
2,589,231
|
||||||
|
Building improvements
|
-
|
253,526
|
||||||
|
Laboratory equipment
|
92,402
|
848,014
|
||||||
|
Office and computer equipment
|
117,259
|
318,254
|
||||||
|
209,661
|
5,116,533
|
|||||||
|
Less accumulated depreciation
|
114,274
|
3,162,037
|
||||||
|
$
|
95,387
|
$
|
1,954,496
|
|||||
|
September 30,
2016
(Unaudited)
|
December 31,
2015
|
|||||||
|
Patents, trademarks and applications, net of accumulated amortization of $575,092 and $548,327, respectively
|
$
|
891,317
|
$
|
1,136,410
|
||||
|
Long-term deposits
|
37,000
|
-
|
||||||
|
Goodwill
|
387,239
|
387,239
|
||||||
|
$
|
1,315,556
|
$
|
1,523,649
|
|||||
|
September 30,
2016
(Unaudited)
|
December 31,
2015
|
|||||||
|
Mortgage notes
|
$
|
-
|
$
|
1,997,701
|
||||
|
Other short-term installment obligations
|
222,135
|
142,328
|
||||||
|
222,135
|
2,140,029
|
|||||||
|
Less current portion
|
222,135
|
301,250
|
||||||
|
$
|
-
|
$
|
1,838,779
|
|||||
|
·
|
Grant date exercise price – the closing market price of the Company's common stock on the date of the grant;
|
|
·
|
Estimated option term – based on historical experience with existing option holders;
|
|
·
|
Estimated dividend rates – based on historical and anticipated dividends over the life of the option;
|
|
·
|
Term of the option – based on historical experience, grants have lives of approximately 3-5 years;
|
|
·
|
Risk-free interest rates – with maturities that approximate the expected life of the options granted;
|
|
·
|
Calculated stock price volatility – calculated over the expected life of the options granted, which is calculated based on the daily closing price of the Company's common stock over a period equal to the expected term of the option; and
|
|
·
|
Option exercise behaviors – based on actual and projected employee stock option exercises and forfeitures.
|
|
Three Months Ended
|
Nine Months Ended
|
|||||||||||||||
|
2016
|
2015
|
2016
|
2015
|
|||||||||||||
|
Selling, general and administrative expenses
|
$
|
144,187
|
$
|
214,848
|
$
|
365,899
|
$
|
910,854
|
||||||||
|
Research and development expenses
|
-
|
23,236
|
2,560
|
108,213
|
||||||||||||
|
Total stock-based compensation
|
$
|
144,187
|
$
|
238,084
|
$
|
368,459
|
$
|
1,019,067
|
||||||||
|
2016
|
2015
|
|||||||
|
Dividend yield
|
0
|
%
|
0
|
%
|
||||
|
Expected price volatility
|
99-100
|
%
|
93
|
%
|
||||
|
Risk free interest rate
|
1.20
|
%
|
1.39
|
%
|
||||
|
Expected term
|
5 years
|
5 years
|
||||||
|
Shares
Underlying
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at January 1, 2016
|
332,560
|
$
|
35.36
|
|||||||||||||
|
Granted
|
227,000
|
2.89
|
||||||||||||||
|
Exercised
|
-
|
-
|
||||||||||||||
|
Forfeited
|
(25,445
|
)
|
36.30
|
|||||||||||||
|
Outstanding at September 30, 2016
|
534,115
|
$
|
21.55
|
7.9
|
$
|
31,780
|
||||||||||
|
Exercisable at September 30, 2016
|
355,403
|
$
|
30.61
|
7.0
|
$
|
8,085
|
||||||||||
|
Nonvested Shares
|
Nonvested
Shares
Underlying
Options
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Grant Date
Fair Value
|
|||||||||
|
Nonvested at January 1, 2016
|
33,336
|
$
|
15.54
|
$
|
11.41
|
|||||||
|
Granted
|
227,000
|
2.89
|
2.13
|
|||||||||
|
Vested
|
(78,004
|
)
|
6.25
|
4.65
|
||||||||
|
Forfeited
|
(3,620
|
)
|
15.13
|
10.75
|
||||||||
|
Nonvested at September 30, 2016
|
178,712
|
$
|
3.54
|
$
|
2.59
|
|||||||
|
Shares
Underlying
Options / Warrants
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual
Term (Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
|
Outstanding at January 1, 2016
|
432,003
|
$
|
15.47
|
|||||||||||||
|
Granted
|
95,000
|
3.78
|
||||||||||||||
|
Exercised
|
-
|
-
|
||||||||||||||
|
Forfeited
|
-
|
-
|
||||||||||||||
|
Outstanding at September 30, 2016
|
527,003
|
$
|
13.36
|
3.0
|
$
|
-
|
||||||||||
|
Exercisable at September 30, 2016
|
432,003
|
$
|
15.47
|
1.5
|
$
|
-
|
||||||||||
| • |
Milestone payments, totaling up to a potential of $1.1 million in the aggregate, based on the satisfactory conclusion of milestones as defined in the License Agreement;
|
| • |
Potential for milestone payments of up to an additional $2 million for development and receipt of regulatory approval for additional licensed products; and
|
| • |
Royalties, at low double digit rates, based on sales of licensed products.
|
|
Category
|
Totals
|
|||
|
License fees and milestone amounts paid / achieved
|
$
|
1,920,000
|
||
|
Third party obligations recorded, including WU
|
(363,700
|
)
|
||
|
Deferred revenue balance
|
1,556,300
|
|||
|
Revenue amortization to September 30, 2016
|
(370,112
|
)
|
||
|
Net deferred revenue balance at September 30, 2016
|
$
|
1,186,188
|
||
|
Commencement of license fees revenue recognition
|
Upon signing or receipt
|
|
|
Commencement of milestone revenue recognition
|
Upon milestone achievement over then remaining life
|
|
|
Original amortization period
|
197 months
|
|
·
|
focusing on the BiOptix business plan to advance on commercial and development activities to increase the value of the operation;
|
|
·
|
exploring prospective partnering or licensing opportunities with appreciable opportunities and technologies;
|
|
·
|
continuing to evaluate options to monetize, partner or license the Company's appendicitis product portfolio; and
|
|
·
|
continuing to implement cost control initiatives to conserve cash.
|
| • |
Milestone payments, totaling up to a potential of $1.1 million in the aggregate, based on the satisfactory conclusion of milestones as defined in the License Agreement;
|
| • |
Potential for milestone payments of up to an additional $2 million for development and receipt of regulatory approval for additional licensed products; and
|
| • |
Royalties, at low double digit rates, based on sales of licensed products.
|
| · |
faulty human judgment and simple errors, omissions or mistakes;
|
| · |
fraudulent action of an individual or collusion of two or more people;
|
| · |
inappropriate management override of procedures; and
|
| · |
the possibility that any enhancements to controls and procedures may still not be adequate to assure timely and accurate financial information.
|
|
EXHIBIT
|
DESCRIPTION
|
|
|
2.1
|
Stock Purchase Agreement, dated as of September 12, 2016, by and among Venaxis, Inc., Venaxis Sub, Inc., as purchaser, BiOptix Diagnostics, Inc., the Sellers who are parties thereto, and the Seller Representative
(incorporated by reference to the Registrant's Current Report on Form 8-K, dated September 12, 2016, and filed September 13, 2016).
|
|
|
10.1
|
Registration Rights Agreement, dated as of September 12, 2016, by and among Venaxis, Inc. and the Sellers party thereto
(incorporated by reference to the Registrant's Current Report on Form 8-K, dated September 12, 2016, and filed September 13, 2016)
.
|
|
|
10.2
|
Form of Lock-Up Agreement between Venaxis, Inc. and each of the Sellers
(incorporated by reference to the Registrant's Current Report on Form 8-K, dated September 12, 2016, and filed September 13, 2016)
.
|
|
|
10.3
|
Offer Letter, dated September 15, 2016, to Richard J. Whitcomb
(incorporated by reference to the Registrant's Current Report on Form 8-K, dated September 21, 2016, and filed September 27, 2016)
.
|
|
|
31.1
|
Rule 13a-14(a)/15d-14(a) - Certification of Chief Executive Officer. Filed herewith.
|
|
|
31.2
|
Rule 13a-14(a)/15d-14(a) - Certification of Chief Financial Officer. Filed herewith.
|
|
|
32
|
Section 1350 Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. Furnished herewith.
|
|
|
101
|
Interactive data files pursuant to Rule 405 of Regulation S-T: (i) the Balance Sheets, (ii) the Statements of Operations, (iii) the Statement of Cash Flows and (iv) the Notes to Condensed Financial Statements.
|
|
Venaxis, Inc.
(Registrant)
|
|||
|
By:
|
/s/ Jeffrey G. McGonegal
|
||
|
Dated:
November 14,
2016
|
Jeffrey G. McGonegal,
Chief Financial Officer and duly authorized officer
|
||
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 |
|---|