Delaware
|
06-1123096
|
(State or other jurisdiction of
|
(I.R.S. Employer Identification No.)
|
Incorporation or organization)
|
Title of Each Class
|
Name of Each Exchange on Which Registered
|
Common Stock, $.004 par value
|
The Nasdaq Capital Market
|
TABLE OF CONTENTS
|
||
PART I
|
Page
|
|
Item 1
|
Business
|
4
|
Item 1A
|
Risk Factors
|
12
|
Item 1B
|
Unresolved Staff Comments
|
18
|
Item 2
|
Properties
|
18
|
Item 3
|
Legal Proceedings
|
19
|
Item 4
|
Mine Safety Disclosures
|
19
|
PART II
|
||
Item 5
|
Market for Registrant's Common Equity, Related Stockholder Matters
and Issuer Purchases of Equity Securities |
19
|
Item 6
|
Selected Financial Data
|
20
|
Item 7
|
Management's Discussion and Analysis of Financial
Condition and Results of Operations |
20
|
Item 7A
|
Quantitative and Qualitative Disclosures About Market Risk
|
26
|
Item 8
|
Financial Statements and Supplementary Data
|
27
|
Report of Independent Registered Public Accounting Firm
|
F-1
|
|
Consolidated Balance Sheets as of December 31, 2016 and 2015
|
F-2 to F-3
|
|
Consolidated Statements of Operations for the Years Ended
December 31, 2016 and 2015 |
F-4
|
|
Consolidated Statements of Changes in Stockholders' Equity
for the Years Ended December 31, 2016 and 2015 |
F-5
|
|
Consolidated Statements of Cash Flows for the Years Ended
December 31, 2016 and 2015 |
F-6
|
|
Notes to Consolidated Financial Statements
|
F-7 to F-19
|
|
Item 9
|
Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure |
29
|
Item 9A
|
Controls and Procedures
|
29
|
Item 9B
|
Other Information
|
29
|
PART III
|
||
Item 10
|
Directors, Executive Officers and Corporate Governance
|
29
|
Item 11
|
Executive Compensation
|
30
|
Item 12
|
Security Ownership of Certain Beneficial Owners and Management
and Related Stockholder Matters |
30
|
Item 13
|
Certain Relationships and Related Transactions and Director Independence
|
30
|
Item 14
|
Principal Accountant Fees and Services
|
30
|
PART IV
|
||
Item 15
|
Exhibits and Financial Statement Schedules
|
31
|
Item 16
|
Form 10-K Summary
|
31
|
Signatures
|
34
|
·
|
FORE-SIGHT sales increased 17% over the prior year, driven by a 22% increase in FORE-SIGHT disposable sensor sales. Sensor revenue growth was attributable to a combination of taking customers from competitors, gaining customers who had not used cerebral oximetry in the past, and increases in sensor sales to existing customers as their utilization expanded.
|
·
|
FORE-SIGHT sales represented 81% of CASMED's total sales from continuing operations in the fourth quarter of 2016, and FORE-SIGHT sensor sales accounted for 71% of total sales.
|
·
|
We shipped a net of 380 FORE-SIGHT monitors worldwide in 2016, raising the cumulative net shipments from launch to 2,088 units as of year-end. The U.S. installed base accounts for 54% of the total shipped, or 1,120 monitors, which represents an increase of 23% over the prior year-end installed base.
|
·
|
The five-year FORE-SIGHT sales compound average growth rate reached 23% at the end of 2016 for overall sales and 28% for U.S. sales. The fourth quarter of 2016 was the 27
th
consecutive quarter of double-digit U.S. FORE-SIGHT sensor sales growth over the prior-year quarter.
|
·
|
CASMED largely accomplished its goal in 2016 to improve the quality of its U.S. distribution team since the hiring of new sales leadership in late 2015. In the past 12 months, We hired ten new sales representatives (to replace former sales reps and to fill new territories) and, as of March 2017, have 15 territories staffed with two open territories we expect to fill by mid-2017.
|
·
|
We continue to gain name-brand hospitals as customers around the world, particularly in the U.S. We count as customers nine of the top 20 U.S. adult cardiac hospitals, as ranked by U.S. News and World Report.
|
·
|
Our gross profit margin increased to 54.6% in 2016, from 51.2% in 2015, as product mix continued to shift to FORE-SIGHT oximetry, and to disposable sensors, in particular, aided further by realized cost reductions.
|
·
|
On March 28, 2016, we sold our neonatal intensive care disposable supplies product line for $3.35 million. This transaction allows for enhanced focus on our FORE-SIGHT oximetry business, provides additional working capital, and is reported in our financial statements as a discontinued operation.
|
·
|
Tissue Oximetry Monitoring
– includes sales of the Company's FORE-SIGHT tissue oximeter monitors, sensors, and accessories.
|
·
|
Traditional Monitoring –
includes sales of the Company's legacy products comprising the OEM sales of the Company's proprietary non-invasive blood pressure technology (MAXNIBP® and MAXIQ™) and legacy monitor service and repair.
|
·
|
CASMED's FORE-SIGHT ELITE monitor emits five wavelengths of light, permitting an increased level of signal acquisition, thus providing sufficient data to solve for other optical variables in the tissue sample, such as melanin in the skin, which would otherwise be confused as hemoglobin signals.
|
·
|
CASMED's FORE-SIGHT sensors are designed with a preferred geometry, maximizing the distance between the light source and the farthest photo-detector, thereby providing a light pathway that penetrates deeper into the tissue, giving a greater tissue sample for interrogation, particularly if the grey matter of the brain is farther from the scalp.
|
·
|
CASMED's FORE-SIGHT patented and proprietary algorithm utilizes a combination of methods to sort out optical signals created by non-critical background tissue that otherwise confound measurement of oxygenated hemoglobin levels.
|
·
|
Hypoxemia: a decrease of hemoglobin oxygen saturation in arterial blood (inadequate oxygenation of the supply);
|
·
|
Ischemia: a decrease in blood flow to the brain caused by inadequate cardiac output, occlusion of cerebral vessels, or increased intracranial pressure (inadequate volume of supply); and
|
·
|
Anemia: a decrease in the concentration of red blood cells in the blood (inadequate oxygen carrying capacity).
|
Financial Information Relating to Sales
|
||||||||||||
Year Ended December 31,
|
||||||||||||
%
|
||||||||||||
2016
|
2015
|
Change
|
||||||||||
Domestic Sales
|
$
|
18,104,755
|
$
|
15,571,093
|
16%
|
|
||||||
International Sales
|
4,133,070
|
3,915,477
|
6%
|
|
||||||||
Total
|
$
|
22,237,825
|
$
|
19,486,570
|
14%
|
|
·
|
FDA clearance and other regulatory approvals;
|
·
|
The accuracy, reliability, and precision of any biologic measurements provided;
|
·
|
Publication of peer-reviewed clinical studies in support of the clinical use of product;
|
·
|
Acceptance by thought-leaders in anesthesia, surgery, perfusion, and other key clinical roles for new technologies, such as cerebral oxygenation monitoring;
|
·
|
Documented correlation to improved patient outcomes and lower costs;
|
·
|
The cost effectiveness of monitoring solutions and overall pricing;
|
·
|
Data interfaces with multi-parameter patient monitoring and data solutions;
|
·
|
The overall ease-of-use and product quality;
|
·
|
The scale and capability of sales and marketing organizations, including established sales distribution channels;
|
·
|
Contractual arrangements with hospitals, hospital systems, buying groups, and professional service providers; and
|
·
|
Proprietary technology.
|
·
|
Advanced algorithm research,
|
·
|
Sensor and optical development,
|
·
|
Hardware development and support, and
|
·
|
Clinical research.
|
·
|
sell products that compete with products that they have contracted to sell for us;
|
·
|
sell our products outside of our pricing guidelines, distorting the market price of our products;
|
·
|
sell our products outside their designated territory or to non-authorized end-users, possibly in violation of the exclusive distribution rights of other distributors;
|
·
|
directly or indirectly distribute products lacking necessary certifications into markets in violation of applicable in-country laws;
|
·
|
fail to adequately promote our products; and/or
|
·
|
fail to provide proper training, repair, and service to our end-users.
|
Quarter Ended
|
High
|
Low
|
||||||
March 31, 2015
|
$
|
1.92
|
$
|
1.16
|
||||
June 30, 2015
|
$
|
1.46
|
$
|
1.09
|
||||
September 30, 2015
|
$
|
1.31
|
$
|
1.02
|
||||
December 31, 2015
|
$
|
1.98
|
$
|
1.13
|
||||
March 31, 2016
|
$
|
1.80
|
$
|
1.42
|
||||
June 30, 2016
|
$
|
2.11
|
$
|
1.43
|
||||
September 30, 2016
|
$
|
1.90
|
$
|
1.62
|
||||
December 31, 2016
|
$
|
1.78
|
$
|
1.54
|
Title of Class
|
Number of Stockholders
|
|
Common stock, $.004 par value
|
1,731
|
|
·
|
FORE-SIGHT sales increased 17% over the prior year, driven by a 22% increase in FORE-SIGHT disposable sensor sales. Sensor revenue growth was attributable to a combination of taking customers from competitors, gaining customers who had not used cerebral oximetry in the past, and increases in sensor sales to existing customers as their utilization expanded.
|
·
|
FORE-SIGHT sales represented 81% of CASMED's total sales from continuing operations in the fourth quarter of 2016, and FORE-SIGHT sensor sales accounted for 71% of total sales.
|
·
|
We shipped a net of 380 FORE-SIGHT monitors worldwide in 2016, raising the cumulative net shipments from launch to 2,088 units as of year-end. The U.S. installed base accounts for 54% of the total shipped, or 1,120 monitors, which represents an increase of 23% over the prior year-end installed base.
|
·
|
The five-year FORE-SIGHT sales compound average growth rate reached 23% at the end of 2016 for overall sales and 28% for U.S. sales. The fourth quarter of 2016 was the 27
th
consecutive quarter of double-digit U.S. FORE-SIGHT sensor sales growth over the prior-year quarter.
|
·
|
CASMED largely accomplished its goal in 2016 to improve the quality of its U.S. distribution team since the hiring of new sales leadership in late 2015. In the past 12 months, we hired ten new sales representatives (to replace former sales reps and to fill new territories) and, as of March 2017, have 15 territories staffed with two open territories we expect to fill by mid-2017.
|
·
|
We continue to gain name-brand hospitals as customers around the world, particularly in the U.S. We count as customers nine of the top 20 U.S. adult cardiac hospitals, as ranked by U.S. News and World Report.
|
·
|
Our gross profit margin increased to 54.6% in 2016, from 51.2% in 2015, as product mix continued to shift to FORE-SIGHT oximetry, and to disposable sensors, in particular, aided further by realized cost reductions.
|
·
|
On March 28, 2016, we sold our neonatal intensive care disposable supplies product line for $3.35 million. This transaction allows for enhanced focus on our FORE-SIGHT oximetry business, provides additional working capital, and is reported in our financial statements as a discontinued operation.
|
Contractual Obligations
|
Total
|
Less than
One Year
|
2 - 3 Years
|
4 - 5 Years
|
More Than
Five Years
|
|||||||||||||||
Operating leases
|
$
|
1,561,617
|
$
|
364,558
|
$
|
608,783
|
$
|
588,276
|
$
|
—
|
||||||||||
Item 8. Financial Statements and Supplementary Data
|
Page
|
Report of Independent Registered Public Accounting Firm
|
F-1
|
Financial Statements
|
|
Consolidated Balance Sheets as of December 31, 2016 and 2015
|
F-2 to F-3
|
Consolidated Statements of Operations for the Years Ended December 31, 2016 and 2015
|
F-4
|
Consolidated Statements of Changes in Stockholders' Equity for the Years Ended December 31, 2016 and 2015
|
F-5
|
Consolidated Statements of Cash Flows for the Years Ended December 31, 2016 and 2015
|
F-6
|
Notes to Consolidated Financial Statements
|
F-7 to F-19
|
2016
|
2015
|
|||||||
Net sales from continuing operations
|
$
|
22,237,825
|
$
|
19,486,570
|
||||
Cost of sales
|
10,091,331
|
9,516,525
|
||||||
Gross profit
|
12,146,494
|
9,970,045
|
||||||
Operating expenses:
|
||||||||
Research and development
|
3,436,618
|
3,514,362
|
||||||
Selling, general and administrative
|
13,575,219
|
13,097,167
|
||||||
Total operating expenses
|
17,011,837
|
16,611,529
|
||||||
Operating loss
|
(4,865,343
|
)
|
(6,641,484
|
)
|
||||
Interest expense
|
1,048,207
|
859,372
|
||||||
Other income
|
(42,521
|
)
|
(4,658
|
)
|
||||
Loss from continuing operations before income taxes
|
(5,871,029
|
)
|
(7,496,198
|
)
|
||||
Income tax benefit
|
(948,422
|
)
|
(209,197
|
)
|
||||
Loss from continuing operations
|
(4,922,607
|
)
|
(7,287,001
|
)
|
||||
Discontinued operations:
|
||||||||
(Loss) income from discontinued operations
|
(201,239
|
)
|
621,826
|
|||||
Gain (loss) on sale of discontinued operations
|
2,911,016
|
(24,120
|
)
|
|||||
Income tax expense
|
948,422
|
209,197
|
||||||
Income from discontinued operations
|
1,761,355
|
388,509
|
||||||
Net loss
|
(3,161,252
|
)
|
(6,898,492
|
)
|
||||
Preferred stock dividend accretion
|
1,482,595
|
1,383,200
|
||||||
Net loss applicable to common stockholders
|
$
|
(4,643,847
|
)
|
$
|
(8,281,692
|
)
|
||
Loss per common share from continuing
|
||||||||
operations - basic and diluted
|
$
|
(0.24
|
)
|
$
|
(0.34
|
)
|
||
Income per common share from discontinued
|
||||||||
operations - basic and diluted
|
0.07
|
0.02
|
||||||
Per share basic and diluted net loss applicable to
|
||||||||
common stockholders
|
$
|
(0.17
|
)
|
$
|
(0.32
|
)
|
||
Weighted-average number of common shares outstanding:
|
||||||||
Basic and diluted
|
26,826,792
|
25,700,942
|
||||||
Preferred Stock
|
Common Stock Issued
|
Common Stock Held in Treasury
|
Additional Paid-in
|
Accumulated
|
||||||||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
Shares
|
Amount
|
Capital
|
Deficit
|
Total
|
||||||||||||||||||||||||||||
BALANCE, December 31, 2014
|
150,000
|
$ |
13,937,640
|
19,563,333
|
$ |
78,253
|
86,000
|
$ |
(101,480
|
)
|
$ |
20,285,008
|
$ |
(31,030,064
|
)
|
$ |
3,169,357
|
|||||||||||||||||||
Net loss
|
(6,898,492
|
)
|
(6,898,492
|
)
|
||||||||||||||||||||||||||||||||
Common stock issued in public offering
|
7,130,000
|
28,520
|
8,488,975
|
8,517,495
|
||||||||||||||||||||||||||||||||
Common stock issued under stock purchase plan
|
9,988
|
40
|
14,615
|
14,655
|
||||||||||||||||||||||||||||||||
Warrants exercised
|
330,401
|
1,322
|
144,078
|
145,400
|
||||||||||||||||||||||||||||||||
Restricted stock issued, net of cancellations
|
358,000
|
1,432
|
(1,432
|
)
|
—
|
|||||||||||||||||||||||||||||||
Stock compensation
|
704,843
|
704,843
|
||||||||||||||||||||||||||||||||||
BALANCE, December 31, 2015
|
150,000
|
13,937,640
|
27,391,722
|
109,567
|
86,000
|
(101,480
|
)
|
29,636,087
|
(37,928,556
|
)
|
5,653,258
|
|||||||||||||||||||||||||
Net loss
|
(3,161,252
|
)
|
(3,161,252
|
)
|
||||||||||||||||||||||||||||||||
Common stock issued under stock purchase plan
|
6,079
|
24
|
9,438
|
9,462
|
||||||||||||||||||||||||||||||||
Common stock issued - options exercised
|
30,951
|
124
|
32,835
|
32,959
|
||||||||||||||||||||||||||||||||
Warrants issued to lenders
|
92,906
|
92,906
|
||||||||||||||||||||||||||||||||||
Stock compensation
|
785,827
|
785,827
|
||||||||||||||||||||||||||||||||||
BALANCE, December 31, 2016
|
150,000
|
$
|
13,937,640
|
27,428,752
|
$
|
109,715
|
86,000
|
$
|
(101,480
|
)
|
$
|
30,557,093
|
$
|
(41,089,808
|
)
|
$
|
3,413,160
|
2016
|
2015
|
|||||||
Patents and other assets
|
$
|
654,566
|
$
|
905,454
|
||||
Patents pending
|
335,702
|
315,826
|
||||||
990,268
|
1,221,280
|
|||||||
Accumulated amortization
|
(199,297
|
)
|
(408,263
|
)
|
||||
Total
|
$
|
790,971
|
$
|
813,017
|
||||
2017
|
$
|
36,300
|
||
2018
|
$
|
32,700
|
||
2019
|
$
|
28,700
|
||
2020
|
$
|
28,200
|
||
2021
|
$
|
27,800
|
2016
|
2015
|
|||||||
Beginning balance
|
$
|
178,424
|
$
|
100,000
|
||||
Provision
|
40,705
|
154,292
|
||||||
Warranty costs incurred
|
(81,109
|
)
|
(75,868
|
)
|
||||
Ending balance
|
$
|
138,020
|
$
|
178,424
|
||||
(3) | DISCONTINUED OPERATIONS |
December 31,
|
December 31,
|
|||||||
2016
|
2015
|
|||||||
Accounts receivable
|
$
|
85,349
|
$
|
697,726
|
||||
Inventories
|
— |
190,830
|
||||||
Property and equipment, net
|
—
|
6,681
|
||||||
Intangible assets
|
—
|
11,102
|
||||||
Total assets associated with
|
||||||||
discontinued operations
|
$
|
85,349
|
$
|
906,339
|
||||
Accounts payable
|
$
|
22,692
|
$
|
144,106
|
||||
Accrued expenses
|
70,250
|
55,834
|
||||||
Total liabilities associated with
|
||||||||
discontinued operations
|
$
|
92,942
|
$
|
199,940
|
||||
2016
|
2015
|
|||||||
Net sales
|
$
|
799,690
|
$
|
4,845,701
|
||||
Cost of sales
|
583,913
|
3,488,243
|
||||||
Gross profit
|
215,777
|
1,357,458
|
||||||
Operating expenses
|
417,016
|
735,632
|
||||||
(Loss) income from discontinued operations before income taxes
|
(201,239
|
)
|
621,826
|
|||||
Gain (loss) on sale of discontinued operations
|
2,911,016
|
(24,120
|
)
|
|||||
Income tax expense
|
(948,422
|
)
|
(209,197
|
)
|
||||
Income from discontinued operations
|
$
|
1,761,355
|
$
|
388,509
|
||||
2016
|
2015
|
|||||||
Balance at beginning of year
|
$
|
110,000
|
$
|
110,000
|
||||
Provision
|
—
|
2,335
|
||||||
Accounts written off
|
—
|
(2,335
|
)
|
|||||
Balance at end of year
|
$
|
110,000
|
$
|
110,000
|
||||
2016
|
2015
|
|||||||
Raw materials
|
$
|
1,027,145
|
$
|
919,870
|
||||
Work in process
|
23,252
|
20,917
|
||||||
Finished goods
|
545,271
|
487,638
|
||||||
Total
|
$
|
1,595,668
|
$
|
1,428,425
|
||||
December 31, 2016
|
December 31, 2015
|
|||||||||||||||||||||||
Principal
|
Unamortized Debt Issuance Cost and Discounts
|
Debt, Net
|
Principal
|
Unamortized Debt Issuance Cost and Discounts
|
Debt, Net
|
|||||||||||||||||||
Balance of term loan
|
$
|
8,000,000
|
$
|
578,678
|
$
|
7,421,322
|
$
|
7,280,000
|
$
|
455,379
|
$
|
6,824,621
|
||||||||||||
Less current portion
|
1,111,111
|
270,640
|
840,471
|
2,817,940
|
200,948
|
2,616,992
|
||||||||||||||||||
Long-term portion
|
$
|
6,888,889
|
$
|
308,038
|
$
|
6,580,851
|
$
|
4,462,060
|
$
|
254,431
|
$
|
4,207,629
|
||||||||||||
2016
|
2015
|
|||||||
Payroll
|
$
|
367,193
|
$
|
261,374
|
||||
Employee compensation
|
791,228
|
525,000
|
||||||
Professional fees
|
287,252
|
310,442
|
||||||
Warranty
|
138,020
|
178,424
|
||||||
Sales and use tax
|
297,844
|
295,014
|
||||||
Other
|
358,448
|
263,248
|
||||||
$
|
2,239,985
|
$
|
1,833,502
|
|||||
2016
|
2015
|
|||||||||||||||||||||||
Weighted-
|
Aggregate
|
Weighted-
|
Aggregate
|
|||||||||||||||||||||
Option
|
Average
|
Intrinsic
|
Option
|
Average
|
Intrinsic
|
|||||||||||||||||||
Shares
|
Exercise Price
|
Value
|
Shares
|
Exercise Price
|
Value
|
|||||||||||||||||||
Outstanding at beginning of year
|
3,374,875
|
$
|
1.95
|
3,106,000
|
$
|
2.05
|
||||||||||||||||||
Granted
|
30,000
|
1.78
|
693,500
|
1.51
|
||||||||||||||||||||
Exercised
|
(30,951
|
)
|
1.61
|
—
|
—
|
|||||||||||||||||||
Cancelled
|
(144,424
|
)
|
1.57
|
(424,625
|
)
|
1.92
|
||||||||||||||||||
Outstanding at end of year
|
3,229,500
|
$
|
1.97
|
$
|
82,250
|
3,374,875
|
$
|
1.95
|
$
|
235,443
|
||||||||||||||
Exercisable at end of year
|
2,360,375
|
$
|
2.08
|
$
|
20,563
|
1,935,000
|
$
|
2.13
|
$
|
52,888
|
||||||||||||||
Vested and expected to vest at end of year
|
3,203,432
|
$
|
1.97
|
$
|
80,399
|
3,331,699
|
$
|
1.95
|
$
|
229,966
|
||||||||||||||
Weighted-average grant-date fair value of options granted during the year
|
$
|
0.98
|
$
|
0.93
|
||||||||||||||||||||
Weighted
|
||||||||||||
Remaining
|
Average
|
Average
|
||||||||||
Range of
|
Number
|
Contractual
|
Exercise
|
Number
|
Exercise
|
|||||||
Exercise Prices
|
Outstanding
|
Life in Years
|
Price
|
Exercisable
|
Price
|
|||||||
$1.20 - $1.26
|
205,000
|
8.6
|
$
|
1.21
|
51,250
|
$
|
1.21
|
|||||
1.64 - 1.98
|
1,786,500
|
7.9
|
1.76
|
1,121,125
|
1.77
|
|||||||
2.09 - 2.54
|
910,000
|
5.7
|
2.15
|
860,000
|
2.16
|
|||||||
2.95 - 3.16
|
328,000
|
3.9
|
3.09
|
328,000
|
3.09
|
|||||||
3,229,500
|
7.3
|
$
|
1.97
|
2,360,375
|
$
|
2.08
|
||||||
2016
|
2015
|
|||||||
Outstanding at beginning of year
|
508,000
|
178,694
|
||||||
Granted
|
—
|
358,000
|
||||||
Cancelled
|
—
|
—
|
||||||
Vested
|
(89,500
|
)
|
(28,694
|
)
|
||||
Outstanding at end of year
|
418,500
|
508,000
|
||||||
2016
|
2015
|
|||||||
Income tax benefit at the statutory rate
|
$
|
(1,996,150
|
)
|
$
|
(2,339,418
|
)
|
||
State income taxes, net of Federal effect
|
(39,714
|
)
|
(88,242
|
)
|
||||
R&D and other tax credits
|
(110,155
|
)
|
(37,054
|
)
|
||||
Change in valuation allowance
|
2,112,165
|
2,434,198
|
||||||
Other
|
33,854
|
30,516
|
||||||
Income tax benefit from continuing operations
|
$
|
—
|
$
|
—
|
||||
2016
|
2015
|
|||||||
Inventories
|
$
|
131,672
|
$
|
207,236
|
||||
Warranty accrual
|
48,293
|
62,431
|
||||||
Allowance for doubtful accounts
|
87,475
|
87,475
|
||||||
Tax credits
|
1,066,052
|
955,897
|
||||||
Deferred gain on sale and leaseback
|
32,052
|
79,162
|
||||||
Restricted stock
|
1,405,001
|
1,178,525
|
||||||
Net operating loss carryforwards
|
13,684,331
|
12,667,926
|
||||||
Other
|
715,845
|
631,497
|
||||||
17,170,721
|
15,870,149
|
|||||||
Prepaid expenses
|
(112,719
|
)
|
(116,842
|
)
|
||||
Fixed assets
|
(498,916
|
)
|
(385,062
|
)
|
||||
Deferred income tax assets and liabilities
|
16,559,086
|
15,368,245
|
||||||
Valuation allowance
|
(16,559,086
|
)
|
(15,368,245
|
)
|
||||
Net deferred income tax assets and liabilities
|
$
|
—
|
$
|
—
|
||||
2017
|
$
|
365,000
|
||
2018
|
319,000
|
|||
2019
|
290,000
|
|||
2020
|
291,000
|
|||
2021
|
297,000
|
|||
Total
|
$
|
1,562,000
|
||
(12) | RECENT ACCOUNTING PRONOUNCEMENTS |
Number of securities
|
Number of securities
|
|||||||||||
to be issued upon
|
Weighted-average
|
remaining available
|
||||||||||
exercise of
|
exercise price of
|
for future issuance
|
||||||||||
outstanding options
|
outstanding options
|
under equity
|
||||||||||
Plan Category
|
and warrants
|
and warrants
|
compensation plans
|
|||||||||
Equity compensation plans approved
|
||||||||||||
by security holders
|
2,729,500
|
$
|
1.98
|
1,637,585
|
||||||||
Equity compensation plans not
|
||||||||||||
approved by security holders
|
951,458
|
1.92
|
—
|
|||||||||
Total
|
3,680,958
|
$
|
1.96
|
1,637,585
|
||||||||
1.1 | Form of Purchase Agreement, dated February 11, 2015, by and between CAS Medical Systems, Inc. and Craig-Hallum Capital Group LLC (19) |
3.1 | Certificate of Incorporation of Registrant (1) |
3.2 | Certificate of Amendment to Certificate of Incorporation of the Registrant filed June 23, 2015 (20) |
3.3 | Amended and Restated Bylaws of Registrant (8) |
10.1* | 1994 Employees' Incentive Stock Option Plan (3) |
10.2* | CAS Medical Systems, Inc. Employee Stock Purchase Plan (4) |
10.3* | CAS Medical Systems, Inc. 2003 Equity Incentive Plan (5) |
10.4* | Form of Option Agreement (2) |
10.5 | Purchase and Sale Agreement between CAS Medical Systems, Inc. and Davis Marcus Partners, Inc. dated June 18, 2007 (6) |
10.6 | Lease Agreement between CAS Medical Systems, Inc. and DMP New Branford, LLC dated September 6, 2007 (6) |
10.7 | Second Amendment to Lease Agreement between CAS Medical Systems, Inc. and Albany Road Branford II LLC, dated January 23, 2017 |
10.8* | Amendment to the CAS Medical Systems, Inc. 2003 Equity Incentive Plan (9) |
10.9* | Employment Agreement with Jeffery A. Baird dated August 10, 2009 (10) |
10.10* | Employment Agreement between CAS Medical Systems, Inc. and Thomas M. Patton dated August 27, 2010 (11) |
10.11* | Inducement Non-Qualified Stock Option Agreement with Thomas M. Patton dated August 27, 2010 (11) |
10.12* | Inducement Restricted Stock Agreement between CAS Medical Systems, Inc. and Thomas M. Patton dated August 27, 2010 (11) |
10.13* | Inducement Restricted Stock Agreement between CAS Medical Systems, Inc. and Thomas M. Patton dated August 27, 2010 (11) |
10.14* | Employment Agreement with Matthew J. Herwig dated January 7, 2011 (12) |
10.15* | Inducement Non-Qualified Stock Option Agreement with Matthew J. Herwig dated January 7, 2011 (12) |
10.16* | Inducement Restricted Stock Agreement with Matthew J. Herwig dated January 7, 2011 (12) |
10.17 | Investment Agreement, dated June 8, 2011, among CAS Medical Systems, Inc. and several Purchasers named therein (13) |
10.18 | Registration Rights Agreement, dated June 9, 2011, among CAS Medical Systems, Inc. and the several Purchasers named therein (13) |
10.19 | Form of Indemnification Agreement, dated June 9, 2011, between CAS Medical Systems, Inc. and the individual members of the Board of Directors of CAS Medical Systems, Inc. (13) |
10.20* | CAS Medical Systems, Inc. 2011 Equity Incentive Plan, as amended (14) |
10.21 | Warrant to Purchase Stock, dated July 31, 2012, issued by the Company to East West Bank (15) |
10.22 | Warrant to Purchase Stock dated May 10, 2013 issued to East West Bank (16) |
10.23* | Employment Agreement with John K. Gamelin dated August 5, 2013 (17) |
10.24* | Employment Agreement with Paul Benni dated May 1, 2008 (17) |
10.25 | Warrant to Purchase Stock, dated June 27, 2014, issued by the Company to GE Capital Equity Investments, Inc. (18) |
10.26 | Asset Purchase Agreement dated March 28, 2016, by and between the Company and Trinity Medical Devices Inc. (21) |
10.27 | Loan and Security Agreement dated June 30, 2016 by and between the Company, Solar Capital Ltd., and Western Alliance Bank (22) |
10.28 | Warrant to Purchase Stock, dated June 30, 2016, issued by the Company to Solar Capital Ltd. (22) |
10.29 | Warrant to Purchase Stock, dated June 30, 2016, issued by the Company to Western Alliance Bank (22) |
21.1 | Subsidiaries of the Registrant |
23.1 | Consent of Independent Registered Public Accounting Firm |
31.1
|
Certification of CEO Pursuant to Rule 13a-14
|
31.2 | Certification of CFO Pursuant to Rule 13a-14 |
32.1
|
Certification of CEO and CFO Pursuant to 18 U.S.C. 1350
|
101
|
Interactive data files pursuant to Rule 405 of Regulation S-T
|
(1) | Incorporated by reference to the Company's Form 10-Q filed August 12, 2011 |
(2) | Incorporated by reference to the Company's Form 10-KSB filed March 31, 2005 |
(3) | Incorporated by reference to the Company's Form S-8 filed October 4, 2000 |
(4) | Incorporated by reference to the Company's Form S-8 filed June 10, 2004, (333-116348) |
(5) | Incorporated by reference to the Company's Form S-8 filed June 10, 2004, (333-116349) |
(6)
|
Incorporated by reference to the Company's Form 8-K filed September 10, 2007
|
(7) | Incorporated by reference to the Company's Form 8-K filed November 30, 2007 |
(8) | Incorporated by reference to the Company's Form 8-K filed February 14, 2008 |
(9) | Incorporated by reference to the Company's Form 8-K filed December 31, 2008 |
(10) | Incorporated by reference to the Company's Form 10-Q filed August 12, 2009 |
(11) | Incorporated by reference to the Company's Form 8-K filed August 27, 2010 |
(12) | Incorporated by reference to the Company's Form 8-K filed January 10, 2011 |
(13) | Incorporated by reference to the Company's Form 8-K filed June 13, 2011 |
(14) | Incorporated by reference to the Company's Proxy Statement filed April 26, 2016 |
(15) | Incorporated by reference to the Company's Form 8-K filed August 2, 2012 |
(16) | Incorporated by reference to the Company's Form 8-K filed May 13, 2013 |
(17) | Incorporated by reference to the Company's Form 10-Q filed August 7, 2013 |
(18) | Incorporated by reference to the Company's Form 8-K filed June 30, 2014 |
(19) | Incorporated by reference to the Company's Form 8-K filed February 11, 2015 |
(20) | Incorporated by reference to the Company's Form 8-K filed June 25, 2015 |
(21) | Incorporated by reference to the Company's Form 10-Q filed May 11, 2016 |
(22) | Incorporated by reference to the Company's Form 8-K filed July 5, 2016. |
CAS MEDICAL SYSTEMS, INC.
|
|||
(Registrant)
|
|||
/s/ Thomas M. Patton
|
Date: March 15, 2017
|
||
By: Thomas M. Patton
|
|||
President and Chief Executive Officer
|
|||
|
|||
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
|
|||
/s / Alan W. Milinazzo
|
Date: March 15, 2017
|
||
Alan W. Milinazzo, Director
|
|||
/s/
Paul A. Molloy
|
Date: March 15, 2017
|
||
Paul A. Molloy
, Director
|
|||
/s/ Gregory P. Rainey
|
Date: March 15, 2017
|
||
Gregory P. Rainey, Director
|
|||
/s/ James E. Thomas
|
Date: March 15, 2017
|
||
James E. Thomas, Director
|
|||
/s/ Kathleen A. Tune
|
Date: March 15, 2017
|
||
Kathleen A. Tune, Director
|
|||
/s/ Kenneth R. Weisshaar
|
Date: March 15, 2017
|
||
Kenneth R. Weisshaar, Director
|
|||
/s/ Thomas M. Patton
|
Date: March 15, 2017
|
||
Thomas M. Patton, President, Chief Executive
|
|||
Officer and Director
|
|||
/s/ Jeffery A. Baird
|
Date: March 15, 2017
|
||
Jeffery A. Baird, Chief Financial Officer
|
|||
(Principal Financial and Accounting Officer)
|
Period
|
Annual Base Rent
|
Monthly Base Rent
|
2/1/2017 – 1/31/2018
|
$274,176.00
|
$22,848.00
|
2/1/2018 – 1/31/2019
|
$279,659.00
|
$23,304.92
|
2/1/2019 – 1/31/2020
|
$285,252.00
|
$23,771.00
|
2/1/2020 – 1/31/2021
|
$290,957.00
|
$24,246.42
|
2/1/2021 – 1/31/2022
|
$296,776.00
|
$24,731.33
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and |
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ Thomas M. Patton
|
||||
Thomas M. Patton
|
|
|||
President and Chief Executive Officer
|
|
|||
Date: March 15, 2017
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b. | Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; |
c. | Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
d. | Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and |
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
|
/s/ Jeffery A. Baird
|
||||
Jeffery A. Baird
|
|
|||
Chief Financial Officer
|
|
|||
Date: March 15, 2017
|
/s/ Thomas M. Patton
|
||||
Thomas M. Patton
|
|
|||
President and Chief Executive Officer
|
|
|||
CAS Medical Systems, Inc.
|
||||
March 15, 2017
|
/s/ Jeffery A. Baird
|
||||
Jeffery A. Baird
|
|
|||
Chief Financial Officer
|
|
|||
CAS Medical Systems, Inc.
|
||||
March 15, 2017
|