|
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
|
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
|
Delaware
|
No. 68-0533453
|
|
(State or Other Jurisdiction of Incorporation or Organization)
|
(
I.R.S.
Employer Identification No.)
|
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.0001 per share
|
CHFS
|
Nasdaq Capital Market
|
Large accelerated filer ☐
|
Accelerated filer ☐
|
|
Non-accelerated filer ☒
|
Smaller reporting company ☒
|
|
Emerging growth company ☐
|
Page Number | ||
PART I—FINANCIAL INFORMATION
|
|
|
Item 1
|
3
|
|
3
|
||
4
|
||
5
|
||
6
|
||
7
|
||
Item 2
|
13
|
|
Item 3
|
19
|
|
Item 4
|
19 | |
PART II—OTHER INFORMATION
|
||
Item 1
|
20
|
|
Item 1A
|
20
|
|
Item 2
|
20
|
|
Item 3
|
20
|
|
Item 4
|
20
|
|
Item 5
|
20
|
|
Item 6
|
20
|
March 31,
2019
|
December 31, 2018
|
|||||||
ASSETS
|
(unaudited)
|
|||||||
Current assets
|
||||||||
Cash and cash equivalents
|
$
|
11,489
|
$
|
5,480
|
||||
Accounts receivable
|
622
|
786
|
||||||
Inventory
|
1,790
|
1,658
|
||||||
Other current assets
|
350
|
203
|
||||||
Total current assets
|
14,251
|
8,127
|
||||||
Property, plant and equipment, net
|
518
|
536
|
||||||
Operating lease right-of-use asset
|
574
|
—
|
||||||
Other assets
|
20
|
113
|
||||||
TOTAL ASSETS
|
$
|
15,363
|
$
|
8,776
|
||||
LIABILITIES AND STOCKHOLDERS’ EQUITY
|
||||||||
Current liabilities
|
||||||||
Accounts payable
|
$
|
1,202
|
$
|
1,133
|
||||
Accrued compensation
|
831
|
1,498
|
||||||
Current portion of operating lease liability
|
171
|
—
|
||||||
Other current liabilities
|
228
|
209
|
||||||
Total current liabilities
|
2,432
|
2,840
|
||||||
Operating lease liability
|
403
|
-
|
||||||
Total liabilities
|
2,835
|
2,840
|
||||||
Commitments and contingencies
|
—
|
—
|
||||||
Stockholders’ equity
|
||||||||
Series A junior participating preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 30,000 shares,
none outstanding
|
—
|
—
|
||||||
Series F convertible preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 535 and 535 shares,
respectively, issued and outstanding 535 and 535, respectively
|
—
|
—
|
||||||
Series G convertible preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 810,142 and 0 shares,
respectively, issued and outstanding 810,142 and 0, respectively
|
||||||||
Preferred stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 39,159,323 and 39,969,465 shares, none
outstanding
|
—
|
—
|
||||||
Common stock as of March 31, 2019 and December 31, 2018, par value $0.0001 per share; authorized 100,000,000 shares, issued and outstanding
2,069,02
0
and 513,445, respectively
|
—
|
—
|
||||||
Additional paid‑in capital
|
215,422
|
204,101
|
||||||
Accumulated other comprehensive income:
|
||||||||
Foreign currency translation adjustment
|
1,221
|
1,223
|
||||||
Accumulated deficit
|
(204,115
|
)
|
(199,388
|
)
|
||||
Total stockholders’ equity
|
12,528
|
5,936
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
15,363
|
$
|
8,776
|
|
|
Three months ended
March 31,
|
||||||
2019
|
2018
|
|||||||
Net sales
|
$
|
1,215
|
$
|
1,037
|
||||
Costs and Expenses:
|
||||||||
Cost of goods sold
|
612
|
901
|
||||||
Selling, general and administrative
|
4,018
|
4,011
|
||||||
Research and development
|
1,310
|
479
|
||||||
Total costs and expenses
|
5,940
|
5,391
|
||||||
Loss from operations
|
(4,725
|
)
|
(4,354
|
)
|
||||
Loss before income taxes
|
(4,725
|
)
|
(4,354
|
)
|
||||
Income tax expense
|
(2
|
)
|
—
|
|||||
Net loss
|
$
|
(4,727
|
)
|
$
|
(4,354
|
)
|
||
Basic and diluted loss per share
|
$
|
(11.47
|
)
|
$
|
(15.12
|
)
|
||
Weighted average shares outstanding – basic and diluted
|
805
|
288
|
||||||
Other comprehensive income:
|
||||||||
Foreign currency translation adjustments
|
$
|
(2
|
)
|
$
|
1
|
|||
Total comprehensive loss
|
$
|
(4,729
|
)
|
$
|
(4,353
|
)
|
Outstanding
Shares of
Common
Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2017
|
271,357
|
$
|
—
|
$
|
197,367
|
$
|
1,227
|
$
|
(182,356
|
)
|
$
|
16,238
|
||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(4,354
|
)
|
(4,354
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
1
|
—
|
1
|
||||||||||||||||||
Stock-based compensation and stock awards, net
|
3
|
—
|
501
|
—
|
—
|
501
|
||||||||||||||||||
Conversion of preferred stock into common stock
|
32,365
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||
Balance March 31, 2018
|
303,725
|
$
|
—
|
$
|
197,868
|
$
|
1,228
|
$
|
(186,710
|
)
|
$
|
12,386
|
Outstanding
Shares of
Common
Stock
|
Common
Stock
|
Additional
Paid in
Capital
|
Accumulated
Other
Comprehensive
Income
|
Accumulated
Deficit
|
Stockholders’
Equity
|
|||||||||||||||||||
Balance December 31, 2018
|
513,445
|
$
|
—
|
$
|
204,101
|
$
|
1,223
|
$
|
(199,388
|
)
|
$
|
5,936
|
||||||||||||
Net loss
|
—
|
—
|
—
|
—
|
(4,727
|
)
|
(4,727
|
)
|
||||||||||||||||
Foreign currency translation adjustment
|
—
|
—
|
—
|
(2
|
)
|
—
|
(2
|
)
|
||||||||||||||||
Stock-based compensation, net
|
3
|
—
|
362
|
—
|
—
|
362
|
||||||||||||||||||
Issuance of common and preferred stock, net
|
455,178
|
—
|
10,959
|
—
|
—
|
10,959
|
||||||||||||||||||
Conversion of preferred stock into common stock
|
1,100,394
|
—
|
—
|
—
|
—
|
—
|
||||||||||||||||||
Balance March 31, 2019
|
2,069,020
|
$
|
—
|
$
|
215,422
|
$
|
1,221
|
$
|
(204,115
|
)
|
$
|
12,528
|
|
Three months ended
March 31,
|
|||||||
2019
|
2018
|
|||||||
Operating Activities:
|
||||||||
Net loss
|
$
|
(4,727
|
)
|
$
|
(4,354
|
)
|
||
Adjustments to reconcile net loss to cash flows used in operating activities:
|
||||||||
Depreciation and amortization
|
59
|
54
|
||||||
Stock-based compensation expense, net
|
362
|
500
|
||||||
Changes in operating assets and liabilities:
|
||||||||
Accounts receivable
|
164
|
(113
|
)
|
|||||
Inventory
|
(132
|
)
|
(937
|
)
|
||||
Other current assets
|
(147
|
)
|
6
|
|||||
Other assets and liabilities
|
112
|
—
|
||||||
Accounts payable and accrued expenses
|
(598
|
)
|
(192
|
)
|
||||
Net cash used in operating activities
|
(4,907
|
)
|
(5,036
|
)
|
||||
Investing Activities:
|
||||||||
Purchases of property and equipment
|
(41
|
)
|
(57
|
)
|
||||
Net cash used in investing activities
|
(41
|
)
|
(57
|
)
|
||||
Financing Activities:
|
||||||||
Net proceeds from public stock offering, net
|
10,959
|
—
|
||||||
Net cash provided by financing activities
|
10,959
|
—
|
||||||
Effect of exchange rate changes on cash
|
(2
|
)
|
2
|
|||||
Net increase (decrease) in cash and cash equivalents
|
6,009
|
(5,091
|
)
|
|||||
Cash and cash equivalents - beginning of period
|
5,480
|
15,595
|
||||||
Cash and cash equivalents - end of period
|
$
|
11,489
|
$
|
10,504
|
||||
Supplemental cash flow information
|
||||||||
Cash paid for income taxes
|
$
|
—
|
$
|
—
|
( in thousands)
|
|
March 31,
2019
|
|
|
December 31,
2018
|
|
||
Finished Goods
|
$
|
623
|
$
|
517
|
||||
Work in Process
|
91
|
34
|
||||||
Raw Materials
|
1,076
|
1,107
|
||||||
Total
|
$
|
1,790
|
$
|
1,658
|
|
March 31
|
|
||||||
2019
|
2018
|
|||||||
Warrants to purchase common stock
|
5,330,721
|
608,787
|
||||||
Series G convertible preferred stock
|
810,142
|
-
|
||||||
Series F convertible preferred stock
|
102,185
|
59,432
|
||||||
Stock options
|
138,104
|
142,537
|
||||||
Restricted stock units
|
-
|
12
|
||||||
Total
|
6,381,152
|
810,768
|
(in thousands, except per share amounts)
|
|
Three
months
|
|
|
Net loss
|
$
|
(4,727
|
)
|
|
Deemed dividend to preferred shareholders (see Note 4)
|
(4,508
|
)
|
||
Net loss after deemed dividend
|
(9,235
|
)
|
||
Weighted average shares outstanding
|
805
|
|||
Basic and diluted loss per share
|
$
|
(11.47
|
)
|
Three-months ended March 31,
|
||||||||
(in thousands)
|
2019
|
2018
|
||||||
Selling, general and administrative expense
|
$
|
326
|
$
|
450
|
||||
Research and development expense
|
36
|
50
|
||||||
Total stock-based compensation expense
|
$
|
362
|
$
|
500
|
• |
Level 1
- Financial instruments with
unadjusted quoted prices listed on active market exchanges.
|
• |
Level 2
- Financial instruments
lacking unadjusted, quoted prices from active market exchanges, including over the counter traded financial instruments. The prices for the financial instruments are determined using prices for recently traded financial instruments with
similar underlying terms as well as directly or indirectly observable inputs, such as interest rates and yield curves that are observable at commonly quoted intervals.
|
• |
Level 3
- Financial instruments that
are not actively traded on a market exchange. This category includes situations where there is little, if any, market activity for the financial instrument. The prices are determined using significant unobservable inputs or valuation
techniques.
|
(in thousands)
|
||||
Operating lease cost
|
$
|
49
|
||
Variable lease cost
|
26
|
|||
Total
|
$
|
75
|
(in thousands)
|
||||
2019
|
$
|
157
|
||
2020
|
213
|
|||
2021
|
219
|
|||
2022
|
55
|
|||
Total lease payments
|
644
|
|||
Less: Interest
|
(70
|
)
|
||
Present value of lease liability
|
$
|
574
|
ITEM 2. |
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Three Months Ended
March 31, 2019
|
Three Months Ended
March 31, 2018
|
Increase (Decrease)
|
% Change
|
|||||||||
$
|
1,215
|
$
|
1,037
|
$
|
178
|
17.2
|
%
|
(
in thousands)
|
Three
Months Ended
March 31, 2019
|
Three
Months Ended
March 31, 2018
|
Increase (Decrease)
|
% Change
|
||||||||||||
Cost of goods sold
|
$
|
612
|
$
|
901
|
$
|
(289
|
)
|
(32.1
|
)%
|
|||||||
Selling, general and administrative
|
$
|
4,018
|
$
|
4,011
|
$
|
7
|
0.2
|
%
|
||||||||
Research and development
|
$
|
1,310
|
$
|
479
|
$
|
831
|
173.5
|
%
|
Incorporated By Reference
|
|
||||||||||||
Exhibit
Number
|
Exhibit Description
|
Form
|
File
Number
|
Date of First Filing
|
Exhibit
Number
|
Filed
Herewith
|
Furnished
Herewith
|
||||||
Fourth Amended and Restated Certificate of Incorporation
|
10
|
001-35312
|
February 1, 2012
|
|
3.1
|
|
|
|
|||||
|
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
January 13, 2017
|
|
3.1
|
|||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
May 23, 2017
|
3.1
|
|
|
|||||||
Certificate of Amendment to the Fourth Amended and Restated Certificate of Incorporation
|
8-K
|
001-35312
|
October 12, 2017
|
3.1
|
|||||||||
Form of Certificate of Designation of Preferences, Rights and Limitations of Series F Convertible Preferred Stock
|
S-1/A
|
333-221010
|
November 17, 2017
|
3.7
|
|||||||||
Certificate of Amendment to Fourth Amended and Restated Certificate of Incorporation, as amended, of CHF Solutions, Inc
|
8-K
|
001-35312
|
January 2, 2019
|
3.1
|
|||||||||
Certificate of Designation of Preferences, Rights and Limitations of Series G Convertible Preferred Stock
|
8-K
|
001-35312
|
March 13, 2019
|
3.1
|
|||||||||
Second Amended and Restated Bylaws
|
8-K
|
001-35312
|
May 23, 2017
|
3.2
|
|||||||||
Form of Series 1 and Series 2 Warrant to purchase shares of common stock
|
S-1/A
|
333-209102
|
February 25, 2019
|
4.10
|
|||||||||
Warrant Agency Agreement, dated as of March 12, 2019, between CHF Solutions, Inc. and American Stock Transfer & Trust
Company, LLC,
|
8-K
|
001-35312
|
March 13, 2019
|
4.2
|
|||||||||
Underwriting Agreement, dated as of March 8, 2019, by and between CHF Solutions, Inc. and Ladenburg Thalmann & Co. Inc.
|
8-K
|
001-35312
|
March 13, 2019
|
1.1
|
Incorporated By Reference | |||||||||||||
Exhibit
Number
|
Exhibit Description
|
Form |
File
Number
|
Date of First Filing
|
Exhibit
Number
|
Filed
Herewith
|
Furnished
Herewith
|
||||||
Consulting Agreement, dated as of January 28, 2019, between CHF Solutions, Inc. and Steve Brandt†
|
10-K
|
001-35312
|
February 21, 2019
|
10.44
|
|||||||||
Form of Employee Proprietary Information, Inventions Assignment and Non-Competition Agreement for the Company’s employees,
including executive officers†
|
X
|
||||||||||||
Offer Letter, by and between, CHF Solutions, Inc. and Claudia Drayton, dated December 9, 2014†
|
X
|
||||||||||||
Offer Letter, by and between, CHF Solutions, Inc. and Nestor Jaramillo, dated May 7, 2019†
|
X
|
||||||||||||
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
X
|
||||||||||||
101.INS
|
XBRL Instance Document
|
X
|
|||||||||||
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
X
|
|||||||||||
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
X
|
101.DEF
|
XBRL Taxonomy Extension Definition Linkbase Document
|
X
|
|||||||||||
101.LAB
|
XBRL Taxonomy Extension Label Linkbase Document
|
X
|
|||||||||||
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
X
|
†
|
Indicates management compensatory plan, contract or arrangement
|
CHF Solutions, Inc.
|
|||
Date: May 9, 2019
|
By:
|
/s/
John L. Erb
|
|
John L. Erb
|
|||
Chief Executive Officer and Chairman of the Board
|
|||
(principal executive officer)
|
|||
Date: May 9, 2019
|
By:
|
/s/ Claudia Drayton
|
|
Claudia Drayton
|
|||
Chief Financial Officer
|
|||
(principal financial officer)
|
THE COMPANY:
CHF Solutions, Inc.
|
EMPLOYEE:
|
|
Sandra Eayrs
Vice President Human Resources
|
||
|
||
Date
|
Date
|
☐ |
No Inventions or improvements.
|
☐ |
See below: Any and all Inventions regarding:
|
☐ |
Additional sheets attached.
|
☐ |
No materials or documents
|
☐ |
See below:
|
|
EMPLOYEE:
|
|
|
Date
|
/s/ Claudia Drayton
|
Date:
12/9/14
|
/s/ Nestor Jaramillo, Jr. | Date: 4/12/19 |
1. |
I have reviewed this Quarterly Report on Form 10-Q of CHF Solutions, Inc. for the quarterly period ended March 31, 2019;
|
2. |
Based on my knowledge, this report does not contain any untrue
statement of a material fact or omit to state a material fact
necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by
this report;
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects
the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined
in Exchange Act Rules 13a-15(e) and 15d-15(e))
and internal control over financial reporting
(as defined in Exchange Act Rules 13a-15(f)
and
15d-15(f))
for the registrant and have:
|
|
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
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5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
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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
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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.
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Date: May 9, 2019
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/s/
John L. Erb
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John L. Erb
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||
Chief Executive Officer
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1. |
I have reviewed this Quarterly Report on Form 10-Q of CHF Solutions, Inc. for the quarterly period ended March 31, 2019.
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2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the
statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
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3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the
financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
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4. |
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-15(e) and 15d-15(e))
and internal control over financial reporting (as defined in Exchange Act Rules
13a-15(f) and 15d-15(f))
for the registrant and have:
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|
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;
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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;
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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
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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
|
5. |
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting,
to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
|
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.
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Date: May 9, 2019
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/s/ Claudia Drayton
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|
Claudia Drayton
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||
Chief Financial Officer
|
(1) | The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and |
(2) | The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. |
Date: May 9, 2019
|
/s/
John L. Erb
|
|
John L. Erb
|
||
Chief Executive Officer
|
(1) |
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
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(2) |
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the
Company.
|
Date: May 9, 2019
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/s/
Claudia Drayton
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|
Claudia Drayton
|
||
Chief Financial Officer
|