x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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☐
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Delaware
(State or other jurisdiction
of incorporation)
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20-8527075
(IRS Employer
Identification No.)
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12400 High Bluff Drive, Suite 600
San Diego, CA 92130
(Address of Principal Executive Offices)
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92130
(Zip Code)
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Large accelerated filer
☐
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Accelerated filer
☐
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Non-accelerated filer
☐
(Do not check if a smaller reporting company)
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Smaller reporting company
x
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Emerging growth company
x
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Page
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PART I.
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Item 1.
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Item 2.
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Item 3.
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Item 4.
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PART II.
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Item 1.
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Item 1A.
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Item 2.
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Item 3.
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Item 4.
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Item 5.
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Item 6.
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l
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our projected financial position and estimated cash burn rate;
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l
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our estimates regarding expenses, future revenues and capital requirements;
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l
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our ability to continue as a going concern;
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l
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our need to raise substantial additional capital to fund our operations;
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l
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our ability to develop our lead product candidate, Amphora (L-lactic acid, citric acid, and potassium bitartrate), as a contraceptive;
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l
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the success, cost and timing of our clinical trials;
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l
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our dependence on third parties in the conduct of our clinical trials;
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l
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our ability to obtain the necessary regulatory approvals to market and commercialize Amphora, our bacterial vaginosis (BV) product candidate and any other product candidate we may seek to develop;
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l
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the potential for changes to current regulatory mandates requiring health insurance plans to cover the United
States Food and Drug Administration (the FDA)-cleared or approved contraceptive products without cost sharing, our ability to obtain third-party payer coverage and adequate reimbursement, and our reliance on the willingness of patients to pay out-of-pocket absent full or partial third-party payer reimbursement; and
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l
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our ability to expand our organization to accommodate potential growth and our ability to retain and attract key personnel.
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except par value and share data)
|
|
June 30, 2018
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December 31, 2017
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||||
Assets
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||||
Current assets:
|
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||||
Cash and cash equivalents
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$
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22,788
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$
|
1,211
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Restricted cash
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554
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|
490
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||
Prepaid and other current assets
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1,133
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653
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Total current assets
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24,475
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2,354
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Property and equipment, net
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717
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848
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Other noncurrent assets
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977
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750
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Total assets
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$
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26,169
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$
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3,952
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Liabilities, convertible preferred stock and stockholders’ equity (deficit)
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||||
Current liabilities:
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||||
Accounts payable
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$
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7,998
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$
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8,999
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Accrued expenses
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11,104
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12,086
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||
Accrued compensation
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1,738
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2,392
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Series D 2X liquidation preference
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—
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79,870
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||
Total current liabilities
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20,840
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103,347
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Deferred rent
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71
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114
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Other noncurrent liabilities
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—
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166
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Total liabilities
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20,911
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103,627
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Commitments and contingencies (Note 6)
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Preferred stock, $0.0001 par value; 5,000,000 and 57,501,624 shares authorized at June 30, 2018 and December 31, 2017, respectively:
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Series A convertible preferred stock, no shares issued and outstanding at June 30, 2018, and 12,618,279 shares issued and outstanding at December 31, 2017
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—
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23,848
|
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||
Series B convertible preferred stock, no shares issued and outstanding at June 30, 2018, and 13,801,318 shares issued and outstanding at December 31, 2017
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—
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43,616
|
|
||
Series C-1 convertible preferred stock, no shares issued and outstanding at June 30, 2018, and 8,558,686 shares issued and outstanding at December 31, 2017
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—
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34,382
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||
Series C convertible preferred stock, no shares issued and outstanding at June 30, 2018, and 5,037,784 shares issued and outstanding at December 31, 2017
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—
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19,469
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Series D redeemable convertible preferred stock, no shares issued and outstanding at June 30, 2018, and 80 shares issued and outstanding at December 31, 2017
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—
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68,556
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Stockholders’ equity (deficit):
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||||
Common stock, $0.0001 par value; 300,000,000 and 4,051,137 shares authorized at June 30, 2018 and December 31, 2017, respectively; 25,199,511 and 2,082,053 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively
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3
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81
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||
Additional paid-in capital
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404,989
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17,650
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Accumulated deficit
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(399,734
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)
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(307,277
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)
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Total stockholders’ equity (deficit)
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5,258
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(289,546
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)
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Total liabilities, convertible preferred stock and stockholders’ equity (deficit)
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$
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26,169
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$
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3,952
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
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Three Months Ended June 30,
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Six Months Ended June 30,
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||||||||||||
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2018
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2017
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2018
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2017
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||||||||
Operating expenses:
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||||||||
Research and development
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$
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11,833
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$
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4,078
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$
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23,792
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$
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6,060
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General and administrative
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11,409
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2,280
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20,436
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5,211
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||||
Total operating expenses
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23,242
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6,358
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44,228
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11,271
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||||
Loss from operations
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(23,242
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)
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(6,358
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)
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(44,228
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)
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(11,271
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)
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||||
Other income (expense):
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||||||||
Interest income
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32
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32
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62
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63
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||||
Other (expense) income, net
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(32
|
)
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64
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(82
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)
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30
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||||
Loss on issuance of warrants
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—
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—
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(47,920
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)
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—
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Change in fair value of Series D 2X liquidation preference
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—
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(250
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)
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(130
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)
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(600
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)
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||||
Total other expense, net
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—
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(154
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)
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(48,070
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)
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(507
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)
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Loss before income tax
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(23,242
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)
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(6,512
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)
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(92,298
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)
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(11,778
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)
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||||
Income tax expense
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(2
|
)
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—
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(2
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)
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(3
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)
|
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Net loss
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(23,244
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)
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(6,512
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)
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(92,300
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)
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(11,781
|
)
|
||||
Accretion of Series D redeemable convertible preferred stock dividends
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—
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|
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(897
|
)
|
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(66
|
)
|
|
(1,785
|
)
|
||||
Net loss attributable to common stockholders
|
$
|
(23,244
|
)
|
|
$
|
(7,409
|
)
|
|
$
|
(92,366
|
)
|
|
$
|
(13,566
|
)
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(1.11
|
)
|
|
$
|
(3.78
|
)
|
|
$
|
(5.15
|
)
|
|
$
|
(6.92
|
)
|
Weighted-average shares used to compute net loss attributable to common stockholders, basic and diluted
|
20,868,554
|
|
|
1,959,904
|
|
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17,937,788
|
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1,959,904
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EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
(Unaudited)
(In thousands, except share data)
|
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Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C-1
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
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Series D
Redeemable Convertible Preferred Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
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Total Stockholders’ Equity (Deficit)
|
||||||||||||||||||||||||||||||||||||
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Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
Shares
|
|
Amount
|
|
|
|
|||||||||||||||||||||||||||
Balance at December 31, 2017
|
12,618,279
|
|
|
$
|
23,848
|
|
|
13,801,318
|
|
|
$
|
43,616
|
|
|
8,558,686
|
|
|
$
|
34,382
|
|
|
5,037,784
|
|
|
$
|
19,469
|
|
|
80
|
|
|
$
|
68,556
|
|
|
81,119,014
|
|
|
$
|
81
|
|
|
$
|
17,650
|
|
|
$
|
(307,277
|
)
|
|
$
|
(289,546
|
)
|
Conversion of convertible preferred stock into Private Evofem common stock (par value $0.001), excluding Series D (see Note 8)
|
(12,618,279
|
)
|
|
(23,848
|
)
|
|
(13,801,318
|
)
|
|
(43,616
|
)
|
|
(8,558,686
|
)
|
|
(34,382
|
)
|
|
(5,037,784
|
)
|
|
(19,469
|
)
|
|
—
|
|
|
—
|
|
|
40,016,067
|
|
|
40
|
|
|
121,275
|
|
|
—
|
|
|
121,315
|
|
|||||||||
Cancellation of restricted stock awards (see Note 11)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(4,759,091
|
)
|
|
(5
|
)
|
|
5
|
|
|
—
|
|
|
—
|
|
|||||||||
Issuance of Private Evofem common stock (par value $0.001) upon cashless exercise of Invesco Warrants (see Note 10)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
154,593,455
|
|
|
155
|
|
|
47,765
|
|
|
—
|
|
|
47,920
|
|
|||||||||
Exchange of 270,969,445 Private Evofem common stock (par value $0.001) for 6,955,456 shares of Neothetics' common stock (par value $0.0001) (see Note 3)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(264,013,989
|
)
|
|
(270
|
)
|
|
270
|
|
|
—
|
|
|
—
|
|
|||||||||
Accretion and payment of Series D dividends (see Note 8)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
66
|
|
|
—
|
|
|
—
|
|
|
(66
|
)
|
|
(157
|
)
|
|
(223
|
)
|
|||||||||
Conversion of Series D dividends and Series D (see Note 8)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(80
|
)
|
|
(5,226
|
)
|
|
6,878,989
|
|
|
1
|
|
|
5,225
|
|
|
—
|
|
|
5,226
|
|
|||||||||
Redemption of Series D 2X liquidation preference upon conversion of Series D (see Note 8)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
80,000
|
|
|
—
|
|
|
80,000
|
|
|||||||||
Deemed contribution upon conversion of Series D (see Note 8)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(49,334
|
)
|
|
—
|
|
|
—
|
|
|
49,334
|
|
|
—
|
|
|
49,334
|
|
|||||||||
Issuance of common stock and WIM Warrants (see Note 8)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(14,062
|
)
|
|
3
|
|
|
—
|
|
|
14,062
|
|
|
—
|
|
|
14,062
|
|
|||||||||
Private placement of common stock (see Note 3)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
1,614,289
|
|
|
—
|
|
|
20,000
|
|
|
—
|
|
|
20,000
|
|
|||||||||
Record pre-merger Neothetics' stockholders' equity and elimination of Neothetics' historical accumulated deficit (see Note 3)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
2,308,430
|
|
|
—
|
|
|
1,946
|
|
|
—
|
|
|
1,946
|
|
|||||||||
Issuance of common stock, pre-funded warrants and common warrants in connection with the Offering, net of underwriting discounts, commissions and offering costs (see Note 9)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
7,436,171
|
|
|
1
|
|
|
36,130
|
|
|
—
|
|
|
36,131
|
|
|||||||||
Issuance of common stock - exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,173
|
|
|
—
|
|
|
42
|
|
|
—
|
|
|
42
|
|
|||||||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
11,351
|
|
|
—
|
|
|
11,351
|
|
|||||||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(92,300
|
)
|
|
(92,300
|
)
|
|||||||||
Balance at June 30, 2018
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
25,199,511
|
|
|
$
|
3
|
|
|
$
|
404,989
|
|
|
$
|
(399,734
|
)
|
|
$
|
5,258
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|
Six Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Cash flows from operating activities:
|
|
|
|
||||
Net loss
|
$
|
(92,300
|
)
|
|
$
|
(11,781
|
)
|
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities:
|
|
|
|
||||
Loss on issuance of warrants
|
47,920
|
|
|
—
|
|
||
Change in fair value of Series D 2X liquidation preference
|
130
|
|
|
600
|
|
||
Stock-based compensation
|
11,351
|
|
|
431
|
|
||
Depreciation and amortization
|
131
|
|
|
113
|
|
||
Changes in operating assets and liabilities:
|
|
|
|
||||
Prepaid and other assets
|
(465
|
)
|
|
55
|
|
||
Accounts payable
|
(1,757
|
)
|
|
958
|
|
||
Accrued expenses and other liabilities
|
(1,249
|
)
|
|
151
|
|
||
Accrued compensation
|
(879
|
)
|
|
(58
|
)
|
||
Deferred rent, net of current portion
|
(207
|
)
|
|
(11
|
)
|
||
Net cash, cash equivalents and restricted cash used in operating activities
|
(37,325
|
)
|
|
(9,542
|
)
|
||
Cash flows from investing activities:
|
|
|
|
||||
Proceeds from sale of Softcup line of business
|
250
|
|
|
250
|
|
||
Cash acquired in connection with the Merger
|
1,900
|
|
|
—
|
|
||
Net cash, cash equivalents and restricted cash provided by investing activities
|
2,150
|
|
|
250
|
|
||
Cash flows from financing activities:
|
|
|
|
||||
Proceeds from issuance of common stock - private placement
|
20,000
|
|
|
—
|
|
||
Proceeds from issuance of common stock, pre-funded warrants and common warrants in connection with the Offering, net of underwriting discounts and commissions
|
37,542
|
|
|
—
|
|
||
Proceeds from issuance of common stock - exercise of stock options
|
42
|
|
|
—
|
|
||
Payment of cash dividends for Series D redeemable convertible preferred stock
|
(157
|
)
|
|
—
|
|
||
Cash paid for offering costs
|
(611
|
)
|
|
(648
|
)
|
||
Net cash, cash equivalents and restricted cash provided by (used in) financing activities
|
56,816
|
|
|
(648
|
)
|
||
Net change in cash, cash equivalents and restricted cash
|
21,641
|
|
|
(9,940
|
)
|
||
Cash, cash equivalents and restricted cash, beginning of period
|
1,701
|
|
|
11,487
|
|
||
Cash, cash equivalents and restricted cash, end of period
|
$
|
23,342
|
|
|
$
|
1,547
|
|
Supplemental disclosure of noncash investing and financing activities:
|
|
|
|
||||
Net assets acquired in connection with the Merger
|
$
|
46
|
|
|
$
|
—
|
|
Public offering costs included in accounts payable and accrued expenses
|
$
|
800
|
|
|
$
|
26
|
|
Conversion of convertible preferred stock into common stock (excluding Series D)
|
$
|
121,315
|
|
|
$
|
—
|
|
Conversion of Series D redeemable convertible preferred stock into common stock
|
$
|
68,622
|
|
|
$
|
—
|
|
Redemption of Series D 2X liquidation preference upon conversion of Series D redeemable convertible preferred stock into common stock
|
$
|
80,000
|
|
|
$
|
—
|
|
1.
|
Description of Business and Basis of Presentation
|
2.
|
Summary of Significant Accounting Policies
|
|
Six Months Ended June 30,
|
||||||
|
2018
|
|
2017
|
||||
Cash and cash equivalents
|
$
|
22,788
|
|
|
$
|
1,027
|
|
Restricted cash
|
554
|
|
|
520
|
|
||
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows
|
$
|
23,342
|
|
|
$
|
1,547
|
|
|
Three and Six Months Ended June 30,
|
||||
|
2018
|
|
2017
|
||
Convertible preferred stock
|
—
|
|
|
1,027,079
|
|
Series D redeemable convertible preferred stock
|
—
|
|
|
5,159,240
|
|
Unvested restricted common stock subject to repurchase
|
—
|
|
|
122,149
|
|
Unvested restricted stock units
|
—
|
|
|
2,566
|
|
Options to purchase common stock
|
3,573,640
|
|
|
160,363
|
|
Warrants to purchase common stock
|
4,775,886
|
|
|
—
|
|
Total
|
8,349,526
|
|
|
6,471,397
|
|
•
|
Recorded Neothetics' assets, liabilities and stockholders' equity at fair value as of the Closing Date, including
$1.9 million
cash and cash equivalents,
$0.5 million
prepaids and other current assets,
$0.4 million
current and noncurrent liabilities and
$1.9 million
common stock (Neothetics had
2,308,430
shares of common stock outstanding as of the Closing Date on a post-split basis at par value of
$0.0001
per share) and additional paid-in capital (including the reclassification of Neothetics' historical accumulated deficit into additional paid-in capital);
|
•
|
Converted each share of Private Evofem’s capital stock including its Series A convertible preferred stock, Series B convertible preferred stock, Series C-1 convertible preferred stock and Series C convertible preferred stock into Private Evofem's common stock on a
one
-for-one basis for an aggregate of
40,016,067
shares. Upon such conversion, reclassified the net proceeds from Private Evofem’s issuance of these preferred stocks to common stock at Private Evofem’s par value and additional paid-in capital, net of par value;
|
•
|
Cancelled
4,759,091
shares of Private Evofem’s unvested restricted common stock at Private Evofem’s par value on a pre-split basis;
|
•
|
Issued warrants for the purchase up to an aggregate of
155,081,982
shares of Private Evofem's common stock to funds affiliated with Invesco Ltd. (the Invesco Warrants), which were immediately net exercised on a cashless basis for
154,593,455
shares of Private Evofem's common stock;
|
•
|
Exchanged
270,969,445
shares of Private Evofem's common stock for
41,732,794
shares of Neothetics’ common stock on a pre-split basis at the common stock exchange ratio of
0.1540
, subject to adjustment for the Reverse Stock Split
|
•
|
Converted
80
shares of Private Evofem’s Series D into
41,273,941
shares of Neothetics' common stock on a pre-split basis (or
6,878,989
on a post-split basis), including:
|
•
|
Sold
1,614,289
shares of the Company's common stock in a private placement for gross proceeds of
$20.0 million
;
|
•
|
Neothetics affected the Reverse Stock Split, and thus the Company adjusted common stock and additional paid-in capital associated with shares issued in connection with the Merger due to the 6:1 reverse stock split; and
|
•
|
Neothetics assumed Private Evofem's 2012 Equity Incentive Plan and each outstanding stock option issued thereunder was converted into the right to purchase the number of shares of Neothetics' common stock equal to approximately
0.1540
, subject to adjustment for the Reverse Stock Split, multiplied by the number of shares of Private Evofem’s common stock issuable upon exercise of the option to purchase shares of Private Evofem’s common stock.
|
|
June 30, 2018
|
|
|
December 31, 2017
|
|
||
Flex note receivable (1)
|
$
|
250
|
|
|
$
|
250
|
|
Other receivable from related parties
|
155
|
|
|
17
|
|
||
Clinical supplies
|
90
|
|
|
119
|
|
||
Insurance
|
270
|
|
|
96
|
|
||
Rent
|
63
|
|
|
63
|
|
||
Research and development costs
|
138
|
|
|
30
|
|
||
Other
|
167
|
|
|
78
|
|
||
Total
|
$
|
1,133
|
|
|
$
|
653
|
|
|
Useful Life
|
|
June 30, 2018
|
|
|
December 31, 2017
|
|
||
Research equipment
|
5 years
|
|
$
|
639
|
|
|
$
|
639
|
|
Computer equipment and software
|
3 years
|
|
6
|
|
|
6
|
|
||
Office furniture
|
5 years
|
|
205
|
|
|
205
|
|
||
Leasehold improvements
|
5 years or less
|
|
340
|
|
|
340
|
|
||
|
|
|
1,190
|
|
|
1,190
|
|
||
Less: accumulated depreciation and amortization
|
|
|
(473
|
)
|
|
(342
|
)
|
||
Total, net
|
|
|
$
|
717
|
|
|
$
|
848
|
|
|
June 30, 2018
|
|
|
December 31, 2017
|
|
||
Flex note receivable, net of current portion
|
$
|
500
|
|
|
$
|
750
|
|
Prepaid Directors & Officers insurance
|
477
|
|
|
—
|
|
||
Total
|
$
|
977
|
|
|
$
|
750
|
|
|
June 30, 2018
|
|
|
December 31, 2017
|
|
||
Clinical studies
|
$
|
9,227
|
|
|
$
|
8,789
|
|
Sublicense fees
|
1,117
|
|
|
2,000
|
|
||
Public offering costs
|
176
|
|
|
135
|
|
||
Board of directors’ fees and related expenses
|
50
|
|
|
247
|
|
||
Legal and other professional fees
|
239
|
|
|
727
|
|
||
Other
|
295
|
|
|
188
|
|
||
Total
|
$
|
11,104
|
|
|
$
|
12,086
|
|
|
June 30, 2018
|
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
||||||||
Money market fund (1)
|
$
|
62
|
|
|
$
|
62
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Total assets
|
$
|
62
|
|
|
$
|
62
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
December 31, 2017
|
|
Quoted Prices in Active Markets for Identical Assets
(Level 1)
|
|
Significant Other Observable Inputs
(Level 2)
|
|
Significant Unobservable Inputs
(Level 3)
|
||||||||
Series D 2X liquidation preference
|
$
|
(79,870
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(79,870
|
)
|
Total liabilities
|
$
|
(79,870
|
)
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
(79,870
|
)
|
|
Series D 2X Liquidation Preference Liability
|
||
Balance at December 31, 2017
|
$
|
79,870
|
|
Change in fair value of Series D 2X liquidation preference
|
130
|
|
|
Redemption of Series D 2X liquidation preference upon conversion of Series D
|
(80,000
|
)
|
|
Balance at June 30, 2018
|
$
|
—
|
|
|
Operating
Leases |
|
Sublease
Income |
|
Net
|
||||||
Year ending December 31, 2018
|
$
|
374
|
|
|
$
|
(75
|
)
|
|
$
|
299
|
|
Year ending December 31, 2019
|
777
|
|
|
(155
|
)
|
|
622
|
|
|||
Year ending December 31, 2020
|
201
|
|
|
(40
|
)
|
|
161
|
|
|||
Total
|
$
|
1,352
|
|
|
$
|
(270
|
)
|
|
$
|
1,082
|
|
|
2018
|
|
2017
|
||||
Receivables
|
$
|
—
|
|
|
$
|
79
|
|
Payables
|
$
|
1,252
|
|
|
$
|
2,021
|
|
Payments
|
$
|
883
|
|
|
$
|
1,018
|
|
Operating and Interest expense
|
$
|
59
|
|
|
$
|
26
|
|
|
Shares
Designated |
|
Original
Issue Price |
|
Shares
Issued and Outstanding |
|
Common
Stock Equivalents (1) |
|
Aggregate
Liquidation Amount |
|
Proceeds,
Net of Issuance Costs |
|||||||||
Series A
|
12,768,492
|
|
|
$
|
1.9579445
|
|
|
12,618,279
|
|
|
12,618,279
|
|
|
$
|
24,706
|
|
|
$
|
23,848
|
|
Series B
|
31,034,696
|
|
|
$
|
3.2222
|
|
|
13,801,318
|
|
|
13,801,318
|
|
|
44,471
|
|
|
43,616
|
|
||
Series C-1
|
8,660,572
|
|
|
$
|
3.97
|
|
|
8,558,686
|
|
|
8,558,686
|
|
|
33,978
|
|
|
34,382
|
|
||
Series C
|
5,037,784
|
|
|
$
|
3.97
|
|
|
5,037,784
|
|
|
5,037,784
|
|
|
20,000
|
|
|
19,469
|
|
||
Series D
(2)(3)
|
80
|
|
|
$
|
500,000
|
|
|
80
|
|
|
|
|
85,160
|
|
|
39,739
|
|
|||
Total
|
57,501,624
|
|
|
|
|
40,016,147
|
|
|
|
|
$
|
208,315
|
|
|
$
|
161,054
|
|
(1)
|
The Series D shares were convertible into shares in the next equity financing (either preferred or common) at a
50%
discount to the fair value price per share of the shares to be issued in the next financing, therefore, the Series D common stock equivalents and the totals for common stock equivalents have been left blank.
|
(2)
|
Aggregate liquidation amount included accrued and unpaid dividends of
$5.2 million
as of
December 31, 2017
.
|
(3)
|
Proceeds, net of issuance costs, included
$35.0 million
in cash and
$5.0 million
from the conversion of the Amended Cosmederm Note (see more discussions below) less issuance costs of approximately
$0.3 million
. This line excluded the Series D 2X liquidation preference net issuance price of
$18.2 million
, the loss on the issuance of Series D of
$35.2 million
, loss on extinguishment of related-party note payable of
$6.7 million
and accrued Series D dividends of
$5.2 million
.
|
•
|
WIM Warrants to purchase up to
2,000,000
shares of common stock as described in
Note 8- Convertible Preferred Stock
, which will become exercisable on January 17, 2019 and shall remain exercisable for
four
years unless there is a completion of an acceleration event as defined by the WIM Warrants agreements;
|
•
|
Warrants to purchase
11,875
shares of common stock that were issued prior to the Merger, which were exercisable as of June 30, 2018 and shall remain exercisable until 2020, 2022 and 2024;
|
•
|
Pre-funded warrants to purchase
1,063,829
shares of common stock in the Offering as described in
Note 9- Public Offering
, which were exercisable on May 24, 2018 and shall remain exercisable until shares are exercised;
|
•
|
Common warrants to purchase
1,700,000
shares of common stock in the Offering, which were exercisable on May 24, 2018 and shall remain exercisable for
seven
years; and
|
•
|
Common warrants to purchase approximately
182
shares of common stock upon exercise of the underwriter's overallotment option, which were exercisable on June 26, 2018 and shall remain exercisable for
seven
years.
|
Common stock issuable upon the exercise of stock options outstanding
|
3,573,640
|
|
Common stock issuable upon the exercise of common stock warrants
|
4,775,886
|
|
Common stock available for future issuance under the 2014 ESPP
|
118,825
|
|
Common stock available for future issuance under the Amended and Restated 2014 Plan
|
1,833,192
|
|
Total common stock reserved for future issuance
|
10,301,543
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Research and development
|
$
|
2,365
|
|
|
$
|
43
|
|
|
$
|
2,595
|
|
|
$
|
90
|
|
General and administrative
|
8,298
|
|
|
169
|
|
|
8,756
|
|
|
341
|
|
||||
Total
|
$
|
10,663
|
|
|
$
|
212
|
|
|
$
|
11,351
|
|
|
$
|
431
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||
|
|
2018
|
|
|
2017
|
|
|
2018
|
|
|
2017
|
|
Expected volatility
|
|
86.8
|
%
|
|
90.6
|
%
|
|
85.9
|
%
|
|
90.9
|
%
|
Risk-free interest rate
|
|
2.8
|
%
|
|
1.9
|
%
|
|
2.8
|
%
|
|
2.2
|
%
|
Expected dividend yield
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Expected term (years)
|
|
5.8
|
|
|
6.0
|
|
|
5.4
|
|
|
5.7
|
|
•
|
Recorded the issuance of 154,593,455 shares of Private Evofem’s common stock upon the cashless exercise of warrants (the Invesco Warrants) issued to funds affiliated with Invesco Ltd., immediately prior to the closing of the Merger and recognized the fair value of the Invesco Warrants upon issuance.
|
•
|
Reclassified the net proceeds from Private Evofem’s issuance of an aggregate of 40,016,067 shares of Private Evofem’s convertible preferred stock to common stock and additional paid-in capital, net of par value, upon conversion to Private Evofem common stock immediately prior to the closing of the Merger.
|
•
|
Recognized the exchange of 270,969,445 shares of Private Evofem common stock and 80 shares of Private Evofem Series D redeemable convertible preferred stock (Series D) outstanding immediately prior to the closing of the Merger for 83,006,735 shares of Neothetics’ common stock in exchange for 87% ownership in Neothetics upon closing of the Merger.
|
•
|
Adjusted for the final change in fair value of Private Evofem’s Series D 2X liquidation preference and reclassified the Series D 2X liquidation preference upon conversion of 80 shares of Private Evofem’s Series D to additional paid-in capital.
|
•
|
Recorded the fair value of the warrants issued to funds affiliated with Woodford Investment Management Ltd (WIM) to purchase up to 2,000,000 shares of the Company's common stock (the WIM Warrants) and related capital contribution upon issuance of the WIM Warrants.
|
•
|
Recorded cash dividends between January 6, 2018 and the Closing Date, paid upon closing of the Merger to WIM.
|
•
|
Recorded $20.0 million in proceeds from the sale of our common stock in a private placement completed immediately after the closing of the Merger (the Private Placement).
|
•
|
Adjusted common stock and additional paid-in capital associated with shares issued in the Merger and Private Placement due to the 6:1 reverse stock split.
|
|
•
|
|
external development expenses incurred under arrangements with third parties, such as fees paid to contract research organizations (CROs) relating to our clinical trials, costs of acquiring and evaluating clinical trial data such as investigator grants, patient screening fees, laboratory work and statistical compilation and analysis, and fees paid to consultants and our scientific advisory board;
|
|
•
|
|
costs to acquire, develop and manufacture clinical trial materials, including fees paid to contract manufacturers;
|
|
•
|
|
payments related to licensed products and technologies;
|
|
•
|
|
costs related to compliance with drug development regulatory requirements;
|
|
•
|
|
employee-related expenses, including salaries, benefits, travel and stock-based compensation expense; and
|
|
•
|
|
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities, depreciation of leasehold improvements and equipment, and research and other supplies.
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
||||||||||||
|
2018
|
|
2017
|
|
2018
|
|
2017
|
||||||||
Allocated third-party development expenses:
|
|
|
|
|
|
|
|
||||||||
Amphora, as a contraceptive
|
$
|
5,419
|
|
|
$
|
2,783
|
|
|
$
|
14,903
|
|
|
$
|
3,738
|
|
Chlamydia/gonorrhea
|
2,538
|
|
|
232
|
|
|
3,072
|
|
|
253
|
|
||||
Bacterial vaginosis
|
220
|
|
|
116
|
|
|
431
|
|
|
321
|
|
||||
Total allocated third-party development expenses
|
8,177
|
|
|
3,131
|
|
|
18,406
|
|
|
4,312
|
|
||||
Unallocated internal research and development expenses:
|
|
|
|
|
|
|
|
||||||||
Stock-based compensation expenses
|
2,365
|
|
|
43
|
|
|
2,595
|
|
|
90
|
|
||||
Payroll related expenses
|
674
|
|
|
689
|
|
|
1,532
|
|
|
1,277
|
|
||||
Other
|
617
|
|
|
215
|
|
|
1,259
|
|
|
381
|
|
||||
Total unallocated internal research and development expenses
|
3,656
|
|
|
947
|
|
|
5,386
|
|
|
1,748
|
|
||||
Total research and development expenses
|
$
|
11,833
|
|
|
$
|
4,078
|
|
|
$
|
23,792
|
|
|
$
|
6,060
|
|
|
•
|
|
per patient trial costs;
|
|
•
|
|
the number of sites included in the trials;
|
|
•
|
|
the length of time required to enroll eligible patients;
|
|
•
|
|
the number of patients that participate in the trials;
|
|
•
|
|
the number of doses that patients receive;
|
|
•
|
|
potential additional safety monitoring or other studies requested by regulatory agencies;
|
|
•
|
|
the phase of development of the product candidate; and
|
|
•
|
|
the efficacy and safety profile of the product candidate.
|
|
Three Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
Research and development
|
$
|
11,833
|
|
|
$
|
4,078
|
|
|
$
|
7,755
|
|
190
|
%
|
|
Three Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
General and administrative
|
$
|
11,409
|
|
|
$
|
2,280
|
|
|
$
|
9,129
|
|
400
|
%
|
|
Three Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
Change in fair value of Series D 2X liquidation preference
|
$
|
—
|
|
|
$
|
(250
|
)
|
|
$
|
250
|
|
(100
|
)%
|
|
Six Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
Research and development
|
$
|
23,792
|
|
|
$
|
6,060
|
|
|
$
|
17,732
|
|
293
|
%
|
|
Six Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
General and administrative
|
$
|
20,436
|
|
|
$
|
5,211
|
|
|
$
|
15,225
|
|
292
|
%
|
|
Six Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
Loss on issuance of warrants
|
$
|
(47,920
|
)
|
|
$
|
—
|
|
|
$
|
(47,920
|
)
|
100
|
%
|
|
Six Months Ended June 30,
|
|
2018 vs. 2017
|
||||||||||
|
2018
|
|
2017
|
|
$ Change
|
% Change
|
|||||||
Change in fair value of Series D 2X liquidation preference
|
$
|
(130
|
)
|
|
$
|
(600
|
)
|
|
$
|
470
|
|
(78
|
)%
|
|
Six Months Ended June 30,
|
|
2018 vs. 2017
|
|||||||
|
2018
|
|
2017
|
|
% Change
|
|||||
Net cash, cash equivalents and restricted cash used in operating activities
|
$
|
(37,325
|
)
|
|
$
|
(9,542
|
)
|
|
291
|
%
|
Net cash, cash equivalents and restricted cash provided by investing activities
|
2,150
|
|
|
250
|
|
|
760
|
%
|
||
Net cash, cash equivalents and restricted cash provided by (used in) financing activities
|
56,816
|
|
|
(648
|
)
|
|
(8,868
|
)%
|
||
Net increase (decrease) in cash, cash equivalents and restricted cash
|
$
|
21,641
|
|
|
$
|
(9,940
|
)
|
|
(318
|
)%
|
Exhibit
No.
|
Exhibit Title
|
Filed
with this Form 10-Q
|
Incorporated by Reference
|
||||
Form
|
|
File No.
|
|
Date Filed
|
|||
4.1
|
|
S-1
|
|
333-224958
|
|
5/16/2018
|
|
4.2
|
|
S-1
|
|
333-224958
|
|
5/16/2018
|
|
10.1Δ
|
|
8-K
|
|
001-36754
|
|
5/8/2018
|
|
10.2Δ
|
|
8-K
|
|
001-36754
|
|
7/3/2018
|
|
10.3Δ
|
|
8-K
|
|
001-36754
|
|
7/3/2018
|
|
10.4Δ
|
|
8-K
|
|
001-36754
|
|
7/3/2018
|
|
10.5Δ
|
|
8-K
|
|
001-36754
|
|
7/3/2018
|
|
10.6Δ
|
|
8-K
|
|
001-36754
|
|
7/3/2018
|
|
10.7Δ
|
X
|
|
|
|
|
|
|
10.8
|
X
|
|
|
|
|
|
|
31.1
|
X
|
|
|
|
|
|
|
31.2
|
X
|
|
|
|
|
|
|
*32.1
|
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 Definition Linkbase Document
|
X
|
|
|
|
|
|
†101.LAB
|
XBRL Taxonomy Extension Labels Linkbase Document
|
X
|
|
|
|
|
|
†101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
X
|
|
|
|
|
|
Δ
|
Management Compensation Plan or arrangement.
|
*
|
Furnished herewith. This certification is being furnished solely to accompany this report pursuant to 18 U.S.C. 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and is not to be incorporated by reference into any filing of the registrant, whether made before or after the date hereof, regardless of any general incorporation by reference language in such filing.
|
†
|
The financial information of Evofem Biosciences, Inc. Quarterly Report on Form 10-Q for the quarter ended June 30, 2018 filed on August 2, 2018 formatted in XBRL (Extensible Business Reporting Language): (i) the Condensed Consolidated Balance Sheets, (ii) Parenthetical Data to the Condensed Consolidated Balance Sheets, (iii) the Condensed Consolidated Statements of Operations, (iv) the Condensed Consolidated Statements of Convertible Preferred Stock and Stockholders' Equity (Deficit), (v) the Condensed Consolidated Statements of Cash Flows, and (vi) Notes to Unaudited Condensed Consolidated Financial Statements, is furnished electronically herewith.
|
|
EVOFEM BIOSCIENCES, INC.
|
|
|
|
|
Date: August 2, 2018
|
By:
|
/s/ Justin J. File
|
|
|
Justin J. File
|
|
|
Chief Financial Officer
(
Principal Financial Officer and Principal Accounting Officer)
|
Evofem Biosciences, Inc. (the
“
Company
”
) has granted to the Participant an option (the
“
Option
”
) to purchase certain shares of Stock of the Company pursuant to the Company’s 2018 Inducement Equity Incentive Plan (the
“
Plan
”
), as follows:
|
Participant:
|
|
Employee ID:
|
|
Date of Grant:
|
|
|
|
Number of Option Shares:
|
|
|
|
Exercise Price:
|
|
|
|
Initial Vesting Date:
|
|
|
|
Option Expiration Date:
|
|
|
|
Tax Status of Option:
|
Nonstatutory Stock Option
|
|
|
Vested Shares:
|
Except as provided in the Option Agreement, the number of Option Shares (disregarding any resulting fractional share) as of any date is determined as follows:
[Insert Vesting Schedule]
|
||
|
|
|
By their signatures below or by electronic acceptance or authentication in a form authorized by the Company, the Company and the Participant agree that the Option is governed by this Grant Notice and by the provisions of the Plan and the Option Agreement, both of which are made a part of this document. The Participant represents that the Participant has read and is familiar with the provisions of the Plan and the Option Agreement, and hereby accepts the Option subject to all of their terms and conditions.
|
EVOFEM BIOSCIENCES, INC.
|
|
PARTICIPANT
|
|
|
|
By:
Justin J. File, CFO
|
|
[NAME]
|
|
|
|
Address: 12400 High Bluff Drive, Suite 600
San Diego, CA 92130
|
|
Address:
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Evofem Biosciences, Inc.;
|
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
|
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.
|
Date: August 2, 2018
|
|
By:
|
/s/ Saundra Pelletier
|
|
|
|
Saundra Pelletier
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(principal executive officer)
|
1.
|
I have reviewed this quarterly report on Form 10-Q of Evofem Biosciences, Inc.;
|
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
|
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.
|
Date: August 2, 2018
|
|
By:
|
/s/ Justin J. File
|
|
|
|
Justin J. File
|
|
|
|
Chief Financial Officer
|
|
|
|
(principal financial officer and principal accounting officer)
|
|
(1)
|
The Quarterly 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 Quarterly Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
Date: August 2, 2018
|
|
By:
|
/s/ Saundra Pelletier
|
|
|
|
Saundra Pelletier
|
|
|
|
President and Chief Executive Officer
|
|
|
|
(principal executive officer)
|
Date: August 2, 2018
|
|
By:
|
/s/ Justin J. File
|
|
|
|
Justin J. File
|
|
|
|
Chief Financial Officer
|
|
|
|
(principal financial officer and principal accounting officer)
|