ITEM 1. Financial Statements
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except par value and share data)
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
December 31, 2018
|
Assets
|
|
|
|
Current assets:
|
|
|
|
Cash and cash equivalents
|
$
|
50,679
|
|
|
$
|
1,330
|
|
Restricted cash
|
401
|
|
|
431
|
|
Prepaid and other current assets
|
1,769
|
|
|
717
|
|
Total current assets
|
52,849
|
|
|
2,478
|
|
Property and equipment, net
|
461
|
|
|
593
|
|
Operating lease right-of-use assets
|
483
|
|
|
—
|
|
Other noncurrent assets
|
622
|
|
|
939
|
|
Total assets
|
$
|
54,415
|
|
|
$
|
4,010
|
|
Liabilities and stockholders’ equity (deficit)
|
|
|
|
Current liabilities:
|
|
|
|
Accounts payable
|
$
|
8,567
|
|
|
$
|
8,882
|
|
Note payable
|
—
|
|
|
4,010
|
|
Accrued expenses
|
7,217
|
|
|
11,513
|
|
Accrued compensation
|
2,259
|
|
|
2,924
|
|
Operating lease liabilities
|
580
|
|
|
—
|
|
Total current liabilities
|
18,623
|
|
|
27,329
|
|
Deferred rent
|
—
|
|
|
37
|
|
Total liabilities
|
18,623
|
|
|
27,366
|
|
Commitments and contingencies (Note 6)
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized; no shares issued and outstanding
|
—
|
|
|
—
|
|
Stockholders’ equity (deficit):
|
|
|
|
Common stock, $0.0001 par value; 300,000,000 shares authorized; 46,426,315 and 25,867,248 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively;
|
5
|
|
|
3
|
|
Additional paid-in capital
|
522,451
|
|
|
409,787
|
|
Accumulated deficit
|
(486,664
|
)
|
|
(433,146
|
)
|
Total stockholders’ equity (deficit)
|
35,792
|
|
|
(23,356
|
)
|
Total liabilities and stockholders’ equity
|
$
|
54,415
|
|
|
$
|
4,010
|
|
See accompanying notes to the condensed consolidated financial statements (unaudited).
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except share and per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
$
|
5,246
|
|
|
$
|
11,833
|
|
|
$
|
13,135
|
|
|
$
|
23,792
|
|
General and administrative
|
6,695
|
|
|
11,409
|
|
|
12,438
|
|
|
20,436
|
|
Total operating expenses
|
11,941
|
|
|
23,242
|
|
|
25,573
|
|
|
44,228
|
|
Loss from operations
|
(11,941
|
)
|
|
(23,242
|
)
|
|
(25,573
|
)
|
|
(44,228
|
)
|
Other income (expense):
|
|
|
|
|
|
|
|
Interest income
|
108
|
|
|
32
|
|
|
126
|
|
|
62
|
|
Other expense, net
|
(7
|
)
|
|
(32
|
)
|
|
(21
|
)
|
|
(82
|
)
|
Loss on issuance of warrants
|
—
|
|
|
—
|
|
|
—
|
|
|
(47,920
|
)
|
Loss on issuance of Purchase Rights
|
(674
|
)
|
|
—
|
|
|
(674
|
)
|
|
—
|
|
Change in fair value of warrants
|
(3,315
|
)
|
|
—
|
|
|
(7,755
|
)
|
|
—
|
|
Change in fair value of Purchase Rights
|
(19,617
|
)
|
|
—
|
|
|
(19,617
|
)
|
|
—
|
|
Change in fair value of Series D 2X liquidation preference
|
—
|
|
|
—
|
|
|
—
|
|
|
(130
|
)
|
Total other expense, net
|
(23,505
|
)
|
|
—
|
|
|
(27,941
|
)
|
|
(48,070
|
)
|
Loss before income tax
|
(35,446
|
)
|
|
(23,242
|
)
|
|
(53,514
|
)
|
|
(92,298
|
)
|
Income tax expense
|
(4
|
)
|
|
(2
|
)
|
|
(4
|
)
|
|
(2
|
)
|
Net loss
|
(35,450
|
)
|
|
(23,244
|
)
|
|
(53,518
|
)
|
|
(92,300
|
)
|
Accretion of Series D redeemable convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
(66
|
)
|
Net loss attributable to common stockholders
|
$
|
(35,450
|
)
|
|
$
|
(23,244
|
)
|
|
$
|
(53,518
|
)
|
|
$
|
(92,366
|
)
|
Net loss per share attributable to common stockholders, basic and diluted
|
$
|
(0.97
|
)
|
|
$
|
(1.11
|
)
|
|
$
|
(1.68
|
)
|
|
$
|
(5.15
|
)
|
Weighted-average shares used to compute net loss attributable to common stockholders, basic and diluted
|
36,732,568
|
|
|
20,868,554
|
|
|
31,941,850
|
|
|
17,937,788
|
|
See accompanying notes to condensed consolidated financial statements (unaudited).
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)
For the Six Months Ended June 30, 2019
(Unaudited)
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Total Stockholders’ Equity (Deficit)
|
|
Shares
|
|
Amount
|
Balance at December 31, 2018
|
25,867,248
|
|
|
$
|
3
|
|
|
$
|
409,787
|
|
|
$
|
(433,146
|
)
|
|
$
|
(23,356
|
)
|
Issuance of common stock upon cash exercise of warrants and issuance of Reload Warrants (see Note 11)
|
2,376,065
|
|
|
—
|
|
|
10,617
|
|
|
—
|
|
|
10,617
|
|
Restricted stock awards issued
|
470,500
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Shares withheld to cover taxes related to vesting of restricted stock awards
|
(1,639
|
)
|
|
—
|
|
|
(6
|
)
|
|
—
|
|
|
(6
|
)
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,962
|
|
|
—
|
|
|
1,962
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(18,068
|
)
|
|
(18,068
|
)
|
Balance at March 31, 2019
|
28,712,174
|
|
|
$
|
3
|
|
|
$
|
422,360
|
|
|
$
|
(451,214
|
)
|
|
$
|
(28,851
|
)
|
Issuance of common stock in connection with the Private Placement (see Note 10)
|
17,777,779
|
|
|
2
|
|
|
68,322
|
|
|
—
|
|
|
68,324
|
|
Issuance of common stock - exercise of stock options
|
16,823
|
|
|
—
|
|
|
46
|
|
|
—
|
|
|
46
|
|
Restricted stock awards issued/restricted stock units released
|
6,000
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Shares withheld to cover taxes related to vesting of restricted stock awards
|
(86,461
|
)
|
|
—
|
|
|
(518
|
)
|
|
—
|
|
|
(518
|
)
|
Reclassification of warrant and Purchase Rights liability to equity
|
—
|
|
|
—
|
|
|
29,726
|
|
|
—
|
|
|
29,726
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
2,515
|
|
|
—
|
|
|
2,515
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(35,450
|
)
|
|
(35,450
|
)
|
Balance at June 30, 2019
|
46,426,315
|
|
|
$
|
5
|
|
|
$
|
522,451
|
|
—
|
|
$
|
(486,664
|
)
|
|
$
|
35,792
|
|
See accompanying notes to condensed consolidated financial statements (unaudited).
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS’ EQUITY (DEFICIT)
For the Six Months Ended June 30, 2018
(Unaudited)
(In thousands, except share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series A
Convertible
Preferred Stock
|
|
Series B
Convertible
Preferred Stock
|
|
Series C-1
Convertible
Preferred Stock
|
|
Series C
Convertible
Preferred Stock
|
|
Series D
Redeemable Convertible Preferred Stock
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Accumulated Deficit
|
|
Total Stockholders’ Equity (Deficit)
|
|
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
|
|
|
2,082,053
|
|
|
$
|
—
|
|
|
$
|
17,731
|
|
|
$
|
(307,277
|
)
|
|
$
|
(289,546
|
)
|
Conversion of convertible preferred stock into common stock, 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
|
)
|
|
—
|
|
|
—
|
|
|
1,027,079
|
|
|
—
|
|
|
121,315
|
|
|
—
|
|
|
121,315
|
|
Cancellation of restricted stock awards (see Note 12)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(122,149
|
)
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Issuance of common stock upon cashless exercise of Invesco Warrants (see Note 11)
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
3,968,473
|
|
|
1
|
|
|
47,919
|
|
|
—
|
|
|
47,920
|
|
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 - exercise of stock options
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
6,173
|
|
|
—
|
|
|
42
|
|
|
—
|
|
|
42
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
688
|
|
|
—
|
|
|
688
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(69,056
|
)
|
|
(69,056
|
)
|
Balance at March 31, 2018
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
17,763,340
|
|
|
$
|
2
|
|
|
$
|
358,196
|
|
|
$
|
(376,490
|
)
|
|
$
|
(18,292
|
)
|
Issuance of common stock, prefunded 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
|
|
Stock-based compensation
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
10,663
|
|
|
—
|
|
|
10,663
|
|
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
(23,244
|
)
|
|
(23,244
|
)
|
Balance at June 30, 2018
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
—
|
|
|
$
|
—
|
|
|
25,199,511
|
|
|
$
|
3
|
|
|
$
|
404,989
|
|
|
$
|
(399,734
|
)
|
|
$
|
5,258
|
|
See accompanying notes to condensed consolidated financial statements (unaudited).
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
2019
|
|
2018
|
Cash flows from operating activities:
|
|
|
|
Net loss
|
$
|
(53,518
|
)
|
|
$
|
(92,300
|
)
|
Adjustments to reconcile net loss to net cash, cash equivalents and restricted cash used in operating activities:
|
|
|
|
Loss on issuance of warrants
|
—
|
|
|
47,920
|
|
Loss on issuance of Purchase Rights
|
674
|
|
|
|
Change in fair value of warrants
|
7,755
|
|
|
—
|
|
Change in fair value of Purchase Rights
|
19,617
|
|
|
|
Change in fair value of Series D 2X liquidation preference
|
—
|
|
|
130
|
|
Stock-based compensation
|
4,477
|
|
|
11,351
|
|
Depreciation
|
132
|
|
|
131
|
|
Noncash lease expenses
|
319
|
|
|
—
|
|
Changes in operating assets and liabilities:
|
|
|
|
Prepaid and other assets
|
(985
|
)
|
|
(465
|
)
|
Accounts payable
|
(478
|
)
|
|
(1,757
|
)
|
Accrued expenses and other liabilities
|
(4,176
|
)
|
|
(1,249
|
)
|
Accrued compensation
|
(665
|
)
|
|
(879
|
)
|
Operating lease liabilities
|
(378
|
)
|
|
—
|
|
Deferred rent, net of current portion
|
—
|
|
|
(207
|
)
|
Net cash, cash equivalents and restricted cash used in operating activities
|
(27,226
|
)
|
|
(37,325
|
)
|
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
|
250
|
|
|
2,150
|
|
Cash flows from financing activities:
|
|
|
|
Proceeds from issuance of common stock- exercise of warrants
|
6,273
|
|
|
—
|
|
Proceeds from issuance of common stock, warrants and Purchase Rights in connection with Private Placement, net of financial advisory fees
|
75,400
|
|
|
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
|
46
|
|
|
42
|
|
Repayment of Note Payable
|
(4,010
|
)
|
|
—
|
|
Payment of cash dividends for Series D redeemable convertible preferred stock
|
—
|
|
|
(157
|
)
|
Cash paid for deferred financing costs
|
(890
|
)
|
|
(611
|
)
|
Payments of tax withholdings related to vesting of restricted stock awards
|
(524
|
)
|
|
—
|
|
Net cash, cash equivalents and restricted cash provided by financing activities
|
76,295
|
|
|
56,816
|
|
Net change in cash, cash equivalents and restricted cash
|
49,319
|
|
|
21,641
|
|
Cash, cash equivalents and restricted cash, beginning of period
|
1,761
|
|
|
1,701
|
|
Cash, cash equivalents and restricted cash, end of period
|
$
|
51,080
|
|
|
$
|
23,342
|
|
Supplemental disclosure of noncash investing and financing activities:
|
|
|
|
Operating right-of-use assets obtained in exchange for new operating lease liabilities
|
$
|
802
|
|
|
$
|
—
|
|
Deferred financing costs included in accounts payable and accrued expenses
|
$
|
257
|
|
|
$
|
800
|
|
Reclassification of warrants and Purchase Rights liability to equity
|
$
|
6,120
|
|
|
$
|
—
|
|
Net assets acquired in connection with the Merger
|
$
|
—
|
|
|
$
|
46
|
|
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
|
|
See accompanying notes to condensed consolidated financial statements (unaudited).
|
|
EVOFEM BIOSCIENCES, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
|
|
|
1.
|
Description of Business and Basis of Presentation
|
Merger
On January 17, 2018, Neothetics, Inc., a Delaware corporation (Neothetics), now known as Evofem Biosciences, Inc. (the Company), completed its merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem), in accordance with the terms of the Agreement and Plan of Merger and Reorganization, dated October 17, 2017 (the Merger Agreement), whereby Nobelli Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Neothetics, merged with and into Private Evofem, with Private Evofem surviving as Neothetics’ wholly-owned subsidiary.
In connection with the Merger, Neothetics filed a certificate of amendment to the amended and restated certificate of incorporation to, among other things, affect a
6
:1 reverse stock split of its common stock (the Reverse Stock Split) and change its name from “Neothetics, Inc.” to “Evofem Biosciences, Inc.” Both the name change and the Reverse Stock Split were effective on January 17, 2018 (the Closing Date). Shares of the Company's common stock commenced trading on The Nasdaq Capital Market under the ticker symbol “EVFM” as of January 18, 2018. See discussions of the transactions in connection with the Merger at
Note 3- Merger and Related Transactions.
Evofem Biosciences, Inc.’s operations include those of its wholly-owned subsidiaries, Evofem Biosciences Operations, Inc., a Delaware corporation; Evofem Inc. (Evofem Inc.), a Delaware corporation; Evofem North America, Inc., a Delaware corporation (ENA); Evofem Limited, LLC, a Delaware limited liability company; and, Evofem Ltd., a limited company registered in England and Wales and those of its partially owned subsidiary, Evolution Pharma, a Dutch limited partnership (EP) with
99%
of the outstanding partnership interests held by Evofem Inc. and
1%
of the outstanding partnership interests held by Evofem Limited, LLC. Evofem Limited, LLC and Evofem Ltd. are currently inactive.
Unless otherwise noted, (i) references in this report to “Evofem” and the “Company” refer to Evofem Biosciences, Inc. and its subsidiaries following the closing of the Merger on the Closing Date, (ii) references to “Private Evofem” refer to Evofem Biosciences Operations, Inc. and its subsidiaries prior to the closing the Merger on the Closing Date, (iii) references to “Neothetics” refer to Neothetics, Inc. and its subsidiaries prior to the closing of the Merger on the Closing Date, and (iv) references to share amounts, figures (other than exchange ratios) and other information have been adjusted to reflect the Reverse Stock Split.
Description of Business
Evofem is a San Diego-based clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. Evofem exists to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). The Company is leveraging its proprietary Multipurpose Vaginal pH Regulator (MVP-R
TM
) platform to develop product candidates for several potential indications, including prevention of pregnancy, prevention of STIs, and reduction of recurrent bacterial vaginosis (BV).
Evofem's MVP-Rs are acid-buffering bioadhesive vaginal gels designed to regulate vaginal pH within the normal range of 3.5 to 4.5. This vaginal pH range is inhospitable to spermatozoa, as well as certain viral and bacterial pathogens associated with STIs, but is integral to the survival of healthy bacteria in the vagina.
Evofem’s lead MVP-R product candidate, Amphora
®
(L-lactic acid, citric acid, and potassium bitartrate), is a non-hormonal, in the moment, woman-controlled vaginal gel. In December 2018 the Company reported top-line data from AMPOWER, its single-arm Phase 3 trial evaluating Amphora for prevention of pregnancy in approximately 1,400 women in the United States. Amphora is also currently being evaluated in a Phase 2b trial for prevention of urogenital transmission of chlamydia and gonorrhea in women (AMPREVENCE). AMPREVENCE was fully enrolled at approximately 50 study centers in the United States at the end of March 2019 and its top-line data is expected in the fourth quarter of 2019.
Evofem’s pipeline also includes an MVP-R product candidate for reduction of recurrent BV. The Company anticipates conducting a Phase 2 clinical trial for this indication, building on favorable Phase 1 trial results.
Basis of Presentation and Principles of Consolidation
Since Private Evofem was determined to be the accounting acquirer in connection with the Merger, it recorded Neothetics’ assets and liabilities at fair value as of the Closing Date. Therefore, for periods prior to the Merger, the condensed consolidated financial statements were prepared on a stand-alone basis for Private Evofem and did not include the combined entities' financial position. Subsequent to the Merger, the condensed consolidated financial statements as of and for the three and six months ended June 30, 2018 from the Closing Date included Neothetics' assets and liabilities.
The Company prepared the unaudited interim condensed consolidated financial statements included in this Quarterly Report in accordance with accounting principles generally accepted in the U.S. (GAAP) for interim financial information and the rules and regulations of the Securities and Exchange Commission (SEC) related to quarterly reports on Form 10-Q.
The Company’s financial statements are presented on a consolidated basis, which include the accounts of the Company and its wholly-owned subsidiaries. Intercompany accounts and transactions have been eliminated in consolidation. The unaudited interim condensed consolidated financial statements do not include all information and disclosures required by GAAP for annual audited financial statements and should be read in conjunction with the Company’s consolidated financial statements and notes thereto for the year ended December 31, 2018 included in its Annual Report on Form 10-K as filed with the SEC on March 1, 2019 (the 2018 Audited Financial Statements).
The unaudited interim condensed consolidated financial statements included in this report have been prepared on the same basis as the Company's audited consolidated financial statements and include all adjustments (consisting only of normal recurring adjustments) necessary for a fair statement of the financial position, results of operations, cash flows, and statements of convertible preferred stock and stockholders’ deficit for the periods presented. The results for the
three and six months ended June 30, 2019
are not necessarily indicative of the results expected for the full year. The condensed consolidated balance sheet as of December 31, 2018 was derived from the 2018 Audited Financial Statements.
Immaterial Restatement
Subsequent to the issuance of the March 31, 2018 and June 30, 2018 interim condensed consolidated financial statements, the Company identified an error in the previously reported amounts of par value of common stock and additional paid-in-capital as of December 31, 2017, which amounts were previously reported as
$81,000
and
$17.7 million
, respectively, on the condensed consolidated balance sheet as of December 31, 2017, and on the condensed consolidated statements of convertible preferred stock and stockholders’ deficit, for the three and six month periods ended March 31, 2018 and June 30, 2018, included in the Company’s Forms 10-Q for these periods. In addition, the number of common shares included in such condensed consolidated statements of convertible preferred stock and stockholders’ deficit were incorrectly presented as of December 31, 2017, and for share activity from January 1, 2018 to the merger consummation date of January 18, 2018. As a result, the Company has corrected the presentation of the amounts of par value of common stock and additional paid-in-capital as of December 31, 2017, and the number of common shares shown as of December 31, 2017 and for share activity from January 1, 2018 to January 18, 2018, to present such dollar and share amounts on a post-split basis, as shown below. This change is reflected in the condensed consolidated statement of convertible preferred stock and stockholders’ deficit for the six months ended June 30, 2018. Management has considered these errors from a qualitative and quantitative perspective and believes the impact of these errors is not material to the financial statements for the applicable periods.
The following table shows the restated number of common shares as of December 31, 2017 and for share activity for the six months ended June 30, 2018, and corresponding common stock par value and additional paid-in-capital as previously reported and as corrected.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As Previously Reported
|
|
As Corrected
|
|
|
Common Stock
|
|
Additional Paid-in Capital
|
|
Common Stock
|
|
Additional Paid-in Capital
|
In thousands, except share data
|
|
Shares
|
|
Amount
|
|
|
Shares
|
|
Amount
|
|
Balance at December 31, 2017
|
|
81,119,014
|
|
|
$
|
81
|
|
|
$
|
17,650
|
|
|
2,082,053
|
|
|
$
|
—
|
|
|
$
|
17,731
|
|
Conversion of convertible preferred stock into common stock, excluding Series D
|
|
40,016,067
|
|
|
40
|
|
|
121,275
|
|
|
1,027,079
|
|
|
—
|
|
|
121,315
|
|
Cancellation of restricted stock awards
|
|
(4,759,091
|
)
|
|
(5
|
)
|
|
5
|
|
|
(122,149
|
)
|
|
—
|
|
|
—
|
|
Issuance of common stock upon cashless exercise of Invesco Warrants
|
|
154,593,455
|
|
|
155
|
|
|
47,765
|
|
|
3,968,473
|
|
|
1
|
|
|
47,919
|
|
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)
|
|
(264,013,989
|
)
|
|
(270
|
)
|
|
270
|
|
|
—
|
|
|
—
|
|
|
—
|
|
Risks, Uncertainties and Going Concern
The financial statements have been prepared on a going concern basis, which contemplates the realization of assets and settlement of liabilities, in the normal course of business, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or amounts and classification of liabilities that may result from the outcome of this uncertainty.
The Company’s principal operations have been related to research and development (R&D), including development of Amphora, as well as raising capital, recruiting personnel and establishing a corporate infrastructure to support a commercial product. The Company has no revenues and, as such, has incurred operating losses and negative cash flows from operating activities since inception. As described in
Note 8- Convertible Preferred Stock
,
Note 9- Public Offering
and
Note 10- Private Placement
, the Company received gross proceeds of approximately
$6.3 million
upon the exercise of warrants in February 2019, and proceeds of approximately
$28.2 million
and
$47.2 million
, net of financial advisory fees, upon the sale and issuance of common stock pursuant to a Private Placement with certain investors in April 2019 and June 2019, respectively. As of
June 30, 2019
, the Company had cash and cash equivalents of
$50.7 million
, working capital of
$34.2 million
and an accumulated deficit of
$486.7 million
.
The Company is subject to risks common to other life science companies in the development stage including, but not limited to, uncertainty of product development and commercialization, lack of marketing and sales history, potential development by its competitors of new technological innovations, dependence on key personnel, market acceptance of products, product liability, protection of proprietary technology, ability to raise additional financing, and compliance with U.S. Food and Drug Administration (FDA) and other government regulations. If the Company does not successfully commercialize any product candidates, it will be unable to generate recurring product revenue or achieve profitability. Management’s plans to meet its short- and long-term operating cash flow requirements include obtaining additional funding, such as through the issuance of its common stock, from other equity or debt financings, or through collaborations or partnerships with other companies.
The Company anticipates it will continue to incur net losses for the foreseeable future and incur additional costs associated with being a public company. R&D expenses are expected to decrease for the foreseeable future due to the completion of the clinical phase of the confirmatory Phase 3 clinical trial for Amphora for prevention of pregnancy. According to management estimates, liquidity resources as of
June 30, 2019
are not sufficient to maintain its planned level of operations for the 12 months from the date of issuance of the financial statements.
These circumstances and the uncertainties associated with the Company's ability to (i) obtain additional equity financing on terms that are favorable to Evofem, (ii) enter into collaborative agreements with strategic partners and (iii) succeed in its future operations raise substantial doubt about the Company's ability to continue as a going concern.
If the Company is not able to obtain the required funding in the near term, through equity financings or other means, or is unable to obtain funding on terms favorable to the Company, this will have a material adverse effect on its operations and strategic development plan for future growth. If the Company cannot successfully raise additional funding and implement its strategic development plan, the Company may be forced to make reductions in spending, extend payment terms with suppliers, liquidate assets where possible, suspend or curtail planned programs or cease operations entirely. Any of these could materially and adversely affect its liquidity, financial condition and business prospects and the Company would not be able to continue as a going concern. If the Company is unable to continue as a going concern, it may have to liquidate its assets and may receive less than the value at which those assets are carried on the financial statements.
Subsequent Events
Subsequent events were evaluated through the filing date of this Quarterly Report, August 6, 2019. See
Note 7- Related-party Transactions
for discussions on subsequent events occurred in July 2019.
|
|
2.
|
Summary of Significant Accounting Policies
|
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and the notes thereto.
S
ignificant estimates affecting amounts reported or disclosed in the consolidated financial statements include, but are not limited to: the discount rate used in estimating the fair value of the operating lease right-of-use (ROU) assets and operating lease liabilities, the measurement of the Series D 2X liquidation preference, assumptions used in estimating the fair value of warrants and Purchase Rights issued, the useful lives of property and equipment, the recoverability of long-lived assets, preclinical and clinical trial accruals, and assumptions used in estimating the fair value of stock-based compensation expense.
The Company’s assumptions regarding the measurement of the Purchase Rights, the Series D 2X liquidation preference, and stock-based compensation are more fully described in
Note 5 — Fair Value of Financial Instruments
and
Note 12 — Stock-based Compensation,
respectively. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances and adjusts when facts and circumstances dictate. The estimates are the basis for making judgments about the carrying values of assets and liabilities and recorded expenses that are not readily apparent from other sources. As future events and their effects cannot be determined with precision, actual results may materially differ from those estimates or assumptions.
Segment Reporting
Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker, who is the Chief Executive Officer (CEO) of the Company, in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in
one
operating segment.
Concentrations of Credit Risk
Financial instruments that potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. Deposits in the Company’s checking and time deposit accounts are maintained in federally insured financial institutions in excess of federally insured limits. The Company invests in funds through a major U.S. bank and is exposed to credit risk in the event of default to the extent of amounts recorded on the consolidated balance sheets.
The Company has not experienced any losses in such accounts and believes it is not exposed to significant concentrations of credit risk on its cash, cash equivalents and restricted cash balances due to the financial position of the depository institutions in which these deposits are held.
Significant Accounting Policies
There have been no changes to the significant accounting policies that were described in Note 2 to the 2018 Audited Financial Statements during the first
six
months of fiscal year 2019, except the accounting policy for leases as disclosed below.
On January 1, 2019 (Adoption Date), the Company adopted Accounting Standards Update (ASU) No. 2016-02,
Leases (Topic 842
) (ASU No. 2016-02), as amended, using the modified retrospective approach, which provides a method for recording existing leases at adoption and does not require recasting comparative financial information. The Company also elected the package of practical expedients permitted under the transition guidance under ASU No. 2016-02
,
which among other things, allowed the Company to not reassess the lease classification for any existing leases, whether any expired or existing contracts are or contain leases and initial direct costs for any existing leases. The Company did not elect the hindsight practical expedient to determine the lease term for existing leases. In addition, the Company elected the additional transition method permitted under ASU No. 2018-11 (
Leases (Topic 842): Targeted Improvements,
under which the Company initially applied the new lease standard, Accounting Standards Codification (ASC) 842, at adoption and there was no cumulative-effect adjustment to the opening balance of retained earnings on January 1, 2019. For the comparative period presented in these condensed consolidated financial statements, lease related disclosures continue to be in accordance with the legacy GAAP, ASC 840.
The Company determines if an arrangement is a lease or implicitly contains a lease at inception based on the definition in accordance with ASC 842. Operating leases are included in operating lease ROU assets and operating lease liabilities in its condensed consolidated balance sheets. ROU assets represent the Company's right to use an underlying asset for the lease term and lease liabilities represent the Company's obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at commencement date or the Adoption Date for existing leases based on the present value of lease payments over the lease term using an estimated discount rate. As the Company's leases do not provide an implicit rate, the Company used an incremental borrowing rate based on the information available at commencement date or the Adoption Date in determining the present value of lease payments over a similar term. In determining the estimated incremental borrowing rate, the Company considered a rate obtained from its primary banker for discussion purposes of a potential collateralized loan with a term similar to the lease term, the Company's historical borrowing capability in the market, and the Company's costs incurred for underwriting discounts and financing costs in its previous equity financing. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Lease and non-lease components within a contract are generally accounted for separately.
Operating lease ROU assets and operating lease liabilities were
$0.5
million and
$0.6 million
, respectively, at
June 30, 2019
. Adoption of the new standard did not materially impact the Company's condensed consolidated statement of operations
and cash flows. See
Note 6 - Commitments and Contingencies
for more detail discussions on leases and financial statements information under ASC 842.
Cash, Cash Equivalents and Restricted Cash
Cash and cash equivalents consist of readily available cash in checking and money market accounts. Restricted cash consists of cash held in monthly time deposit accounts, which are collateral for the Company’s credit cards and facility lease.
The following table provides a reconciliation of cash, cash equivalents and restricted cash, reported within the condensed consolidated statements of cash flows (in thousands):
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
2019
|
|
2018
|
Cash and cash equivalents
|
$
|
50,679
|
|
|
$
|
22,788
|
|
Restricted cash
|
401
|
|
|
554
|
|
Total cash, cash equivalents and restricted cash presented in the condensed consolidated statements of cash flows
|
$
|
51,080
|
|
|
$
|
23,342
|
|
Net Loss Per Share
Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and potentially dilutive securities outstanding for the period determined using the treasury-stock and if-converted methods. For purposes of the diluted net loss per share calculation, potentially dilutive securities are excluded from the calculation of diluted net loss per share because their effect would be anti-dilutive and, therefore, basic and diluted net loss per share were the same for all periods presented. Potentially dilutive securities excluded from the calculation of diluted net loss per share are summarized in the table below.
|
|
|
|
|
|
|
|
Three and Six Months Ended June 30,
|
|
2019
|
|
2018
|
Unvested restricted stock subject to repurchase
|
344,325
|
|
|
—
|
|
Unvested restricted stock units
|
151,500
|
|
|
—
|
|
Common stock to be purchased under the 2019 ESPP
|
42,290
|
|
|
—
|
|
Options to purchase common stock
|
6,134,179
|
|
|
3,573,640
|
|
Warrants to purchase common stock
|
6,369,270
|
|
|
4,775,886
|
|
Total
|
13,041,564
|
|
|
8,349,526
|
|
Recently Adopted Accounting Pronouncements
The Company qualifies as an “emerging growth company” (EGC) pursuant to the provisions of the Jumpstart Our Business Startups (JOBS) Act and expects to continue to qualify as an EGC until December 31, 2019. Section 7(a)(2)(B) of the Securities Act of 1933, as amended, permits EGCs to defer compliance with new or revised accounting standards until non-issuers are required to comply with such standards. However, the Company elected not to take advantage of the extended transition period for implementation of new or revised financial accounting standards, and as a result, the Company will comply with new or revised accounting standards on the relevant dates on which adoption of such standards is required for non-emerging growth companies.
As described above, on January 1, 2019, the Company adopted ASU No. 2016-02, as amended, applying the practical expedients as a package allowed under the transition guidance.
Recently Issued Accounting Pronouncements — Not Yet Adopted
In August 2018, the FASB issued ASU No. 2018-13,
Fair Value Measurement (Topic 820
) (ASU No. 2018-13), which removes, modifies and adds certain disclosure requirements on fair value measurements in Topic 820. ASU No. 2018-13 will be effective for the Company beginning January 1, 2020. Early adoption is permitted. The Company does not plan to early adopt this new standard and does not expect the adoption of this new standard to have an impact on current disclosures in its consolidated financial statements.
3. Merger and Related Transactions
As described in
Note 1- Description of Business and Basis of Presentation,
Private Evofem merged with the Company effective on the Closing Date. The Merger was accounted for as a reverse recapitalization with Private Evofem treated as the accounting acquirer pursuant to ASC 805-
Business Combinations.
Under reverse recapitalization accounting, the accounting acquirer shall measure the identifiable assets acquired, the liabilities assumed, and any noncontrolling interest in the acquiree at their acquisition-date fair values.
The following transactions were completed with the Merger and recorded by the Company:
|
|
•
|
Recorded Neothetics’ assets and liabilities at fair value as of the Closing Date, including
$1.9 million
of cash and cash equivalents,
$0.5 million
in prepaid and other current assets,
$0.4 million
in current and noncurrent liabilities and
$1.9 million
in 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 the Company's common stock on a
one
-for-one basis effecting the merger exchange ratio of
0.1540
, subject to adjustment for the Reverse Stock Split (the Exchange Ratio) and the Reverse Stock Split for an aggregate of
1,027,079
shares. Upon such conversion, reclassified the net proceeds from issuance of these preferred stocks to common stock at par value and additional paid-in capital, net of par value;
|
|
|
•
|
Cancelled
122,149
shares of unvested restricted common stock;
|
|
|
•
|
Issued warrants for the purchase up to an aggregate of
3,980,437
shares of common stock to funds affiliated with Invesco Ltd. (the Invesco Warrants), which were immediately net exercised on a cashless basis for
3,968,473
shares of common stock;
|
|
|
•
|
Converted
80
shares of Private Evofem’s Series D redeemable convertible preferred stock (Series D) into
6,878,989
shares of the Company's common stock, including:
|
i. Adjustment for the final change in fair value of Private Evofem’s Series D 2X liquidation preference;
ii. Redemption of the Series D 2X liquidation preference upon conversion;
iii. Private Evofem’s Series D Warrant Rights (as defined below) were assumed by the Company and exchanged for
three
shares of the Company's common stock and warrants for the purchase of
2,000,000
shares of the Company's common stock (the WIM Warrants). The Company recorded the fair value of the WIM Warrants and related capital contribution upon issuance of the WIM Warrants; and
iv. Recording cash dividends between January 6, 2018 and the Closing Date, which was paid upon closing of the Merger to Woodford Investment Management Ltd. (WIM).
|
|
•
|
The Company effected 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, which the Company has affected in the amounts described within this footnote;
|
|
|
•
|
The Company assumed options to purchase Private Evofem common stock that were outstanding and unexercised as of immediately prior to the Merger (the Private Evofem Plan Options). The Private Evofem Plan Options were converted into options to purchase
159,325
shares of the Company' common stock, as adjusted for the Exchange Ratio and Reverse Stock Split, at a weighted average price of
$56.72
; and
|
|
|
•
|
Sold
1,614,289
shares of the Company's common stock in a private placement for gross proceeds of
$20.0 million
.
|
4. Balance Sheet Details
Prepaid and Other Current Assets
Prepaid and other current assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
|
December 31, 2018
|
|
Flex note receivable
(1)
|
$
|
250
|
|
|
$
|
250
|
|
Insurance
|
883
|
|
|
199
|
|
Prepaid marketing costs
|
279
|
|
|
—
|
|
Other
|
357
|
|
|
268
|
|
Total
|
$
|
1,769
|
|
|
$
|
717
|
|
_______________________
(1)
In June 2016, Private Evofem’s board of directors committed to a plan to sell its Softcup line of business (Softcup) and re-direct its available cash resources to further develop Amphora. In July 2016, the Company entered into an Asset Purchase Agreement with The Flex Company (Flex), whereby Flex would acquire certain assets and assume certain liabilities associated with Softcup. Total consideration for the Softcup sale was
$1.9 million
, with
$0.6 million
received in cash at closing and the remaining
$1.3 million
due and payable under a note in favor of the Company (the Flex Note) through January 1, 2021 (the Maturity Date). The Flex Note bears simple interest at a rate of
5.0%
per annum on the remaining principal amount outstanding. An annual principal payment of approximately
$0.3 million
and the annual accrued and unpaid interest are payable each January 1, beginning in 2017 through the Maturity Date.
The Flex Note is secured by the Softcup assets and has been recorded at present value. The Company’s incremental borrowing rate and the stated interest rate of the Flex Note are materially consistent.
Property and Equipment, Net
Property and equipment, net, consists of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
Useful Life
|
|
June 30, 2019
|
|
|
December 31, 2018
|
|
Research equipment
|
5 years
|
|
$
|
639
|
|
|
$
|
639
|
|
Computer equipment and software
|
3 years
|
|
13
|
|
|
13
|
|
Office furniture
|
5 years
|
|
205
|
|
|
205
|
|
Leasehold improvements
|
5 years or less
|
|
340
|
|
|
340
|
|
|
|
|
1,197
|
|
|
1,197
|
|
Less: accumulated depreciation
|
|
|
(736
|
)
|
|
(604
|
)
|
Total, net
|
|
|
$
|
461
|
|
|
$
|
593
|
|
Depreciation expense was
$66,000
and
$65,000
for the
three months ended June 30, 2019
and
2018
, respectively, and
$0.1 million
for both the
six months ended June 30, 2019
and 2018.
Other Noncurrent Assets
Other noncurrent assets consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
|
December 31, 2018
|
|
Flex note receivable, net of current portion
|
$
|
250
|
|
|
$
|
500
|
|
Prepaid directors & officers insurance
|
372
|
|
|
439
|
|
Total
|
$
|
622
|
|
|
$
|
939
|
|
Note Payable
On December 5, 2018, the Company entered into a promissory note (Note) with our clinical research organization (CRO) for AMPOWER, where the Company agreed to pay the CRO on invoiced amounts totaling approximately
$4.0 million
for clinical trial related services and had a due date of February 15, 2019. Any matured and unpaid amounts pursuant to this Note bear an annual interest rate of the lesser of
1%
per month or the maximum amount permitted by the Laws of the State of Massachusetts.
In late February 2019, the Company amended the Note, which extended the due date to April 15, 2019. In April 2019, the Company paid the Note in full.
Accrued Expenses
Accrued expenses consist of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
|
December 31, 2018
|
|
Clinical studies
|
$
|
5,299
|
|
|
$
|
9,153
|
|
Sublicense fees payable to related parties
|
1,117
|
|
|
1,117
|
|
Accrued interest on unpaid sublicense fees payable to related parties
|
174
|
|
|
174
|
|
Legal and other professional fees
|
376
|
|
|
549
|
|
Other
|
251
|
|
|
520
|
|
Total
|
$
|
7,217
|
|
|
$
|
11,513
|
|
5. Fair Value of Financial Instruments
The fair values of the Company’s assets, including the money market fund and Flex Note receivable, measured on a recurring basis are summarized in the following tables, as applicable (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
June 30, 2019
|
|
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)
|
$
|
13
|
|
|
$
|
13
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Flex note receivable
|
500
|
|
|
—
|
|
|
500
|
|
|
—
|
|
Total assets
|
513
|
|
|
13
|
|
|
500
|
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 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)
|
$
|
154
|
|
|
$
|
154
|
|
|
$
|
—
|
|
|
$
|
—
|
|
Flex note receivable
|
750
|
|
|
—
|
|
|
750
|
|
|
—
|
|
Total assets
|
904
|
|
|
154
|
|
|
750
|
|
|
—
|
|
_______________________
(1)
Included as a component of cash and cash equivalents on the accompanying condensed consolidated balance sheet.
As discussed in
Note 10- Private Placement
, the First Closing Warrants and Purchase Rights were determined to be liability classified. Therefore, they were stated at fair value at issuance and subject to mark-to-market at each reporting date until a subsequent event occurred that would change their classification from liability to equity. Series D 2X liquidation preference issued in connection with the issuance of Series D in 2016 and 2017 was also stated at fair value.
The First Closing Warrants, Purchase Rights and Series D 2X liquidation preference were considered Level 3 instruments because the fair value measurement was based, in part, on significant inputs not observed in the market. The Company determined the fair value of these three instruments as described below.
The following table summarizes the changes in Level 3 financial liabilities measured at fair value on a recurring basis for the three and six months ended June 30, 2019 and
six months ended June 30, 2018
(in thousands). There were no activities for the three months ended June 30, 2018.
|
|
|
|
|
|
Warrant Liability
|
Balance at December 31, 2018
|
$
|
—
|
|
Initial warrant liability at issuance
|
3,611
|
|
Change in fair value of warrants
|
3,315
|
|
Reclassification from warrant liability to equity
|
(6,926
|
)
|
Balance at June 30, 2019
|
$
|
—
|
|
|
|
|
|
|
|
Purchase Rights Liability
|
Balance at December 31, 2018
|
$
|
—
|
|
Initial purchase rights liability at issuance
|
3,183
|
|
Change in fair value of purchase rights
|
19,617
|
|
Reclassification from purchase rights liability to equity
|
(22,800
|
)
|
Balance at June 30, 2019
|
$
|
—
|
|
|
|
|
|
|
|
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
|
$
|
—
|
|
First Closing Warrants
The fair value of the First Closing Warrants issued in April 2019 in connection with the Private Placement and the change in fair value of warrants as a result of mark-to-market were determined using the Black-Scholes-Merton (BSM) option-pricing model based on the following weighted-average assumptions for the periods indicated.
|
|
|
|
|
Three and Six Months Ended June 30, 2019
|
Expected volatility
|
75.0
|
%
|
Risk-free interest rate
|
2.2
|
%
|
Expected dividend yield
|
—
|
%
|
Expected term (years)
|
6.9
|
|
Purchase Rights
The fair value of the Purchase Rights issued during the First Closing in connection with the Private Placement and the change in fair value of Purchase Rights as a result of the mark-to-market due to their classification change from liability to equity upon stockholder approval of the Private Placement were determined using a combination of a lattice model and a BSM option-pricing model. The lattice model was used to determine a range of future value of the Company's common stock as of the Second Closing. The BSM option-pricing model was used to determine the fair value of the warrants issued at the Second Closing and the existing warrants subsequently canceled at the Second Closing (see discussion of the warrants canceled in
Note 10- Private Placement
) based on the applicable assumptions, including the future value of the Company's common stock as determined by the lattice model, warrants exercise price, time to expiration, expected volatility of our peer group, risk-free interest rate and expected dividend. The fair value of the Purchase Rights was then calculated as the difference between the sum of the future value of the Company's common stock and value of the Second Closing warrants, and the sum of the purchase price of
$4.50
for the Second Closing and the value of canceled warrants. The fair value of the Purchase Rights was calculated through backward induction within the lattice model framework.
Series D 2X Liquidation Preference
As described in Note 2 to the 2018 Audited Financial Statements, under the terms of the Series D issued, in a liquidation transaction Private Evofem’s Series D participated, prior and in preference to the other series of convertible preferred stock and common stock, at a rate of two times its initial investment, plus accrued and unpaid dividends (the Series D 2X Liquidation Preference). The Company determined the Series D 2X Liquidation Preference represented an embedded derivative, which required bifurcation and separate liability accounting and was initially recorded at fair value. See the
Series D Redeemable Convertible Preferred Stock
discussion in
Note 8 — Convertible Preferred Stock
for the terms of the Series D.
To determine the final fair value of the Series D 2X liquidation preference, the Company utilized a hybrid valuation model that considers the probability of achieving certain exit scenarios, the Company’s cost of capital, the estimated period the Series D 2X liquidation preference would be outstanding, consideration received for the instrument with the Series D 2X liquidation preference and at what price and changes, if any, in the fair value of the underlying instrument to the Series D 2X liquidation preference. At December 31, 2017, the most significant assumption was the probability of occurrence, which was concluded to be high, and as a result the fair value as of December 31, 2017 approximated the final redemption value.
In connection with the Merger, Private Evofem converted
80
shares of Series D into the Company's common stock. The valuations resulted in a concluded fair value of the Series D 2X liquidation preference of
$80.0 million
as of the Closing
Date, which was reclassified from a Series D 2X liquidation preference to additional paid-in capital upon the conversion into the Company's common stock.
The change in fair value of the Series D 2X liquidation preference for the six months ended June 30, 2018 was
$0.1 million
. There was
no
such change for the three months ended June 30, 2018, and three and six months ended
June 30, 2019
as the Series D was converted into common stock in connection with the Merger.
6. Commitments and Contingencies
Operating Leases
2015 Lease
Effective January 30, 2015, Private Evofem entered into a sublease for office space under a noncancelable lease agreement that expires in March 2020 (the 2015 Lease), which is the Company's primary office space. The sublease provides for two renewal periods of
five
years each, but the sub-lessor is not expected to renew its lease. In lieu of paying a security deposit directly to the sub-lessor, the Company maintains a time deposit in favor of the sub-lessor (the Deposit), which is included in restricted cash in the condensed consolidated balance sheets. During months 13 through 58 of the 2015 Lease term, subject to certain restrictions, approximately
$5,000
of the Deposit may be released each month through November 2019 and approximately
$66,000
of the Deposit may be released each month between December 2019 and March 2020. As of
June 30, 2019
and
December 31, 2018
, restricted cash maintained as collateral for the Company’s Deposit was
$0.3 million
for both periods.
Concurrent with the execution of the 2015 Lease, Private Evofem entered into a sublease with WomanCare Global Trading, Inc. (WCGT) whereby WCGT agreed to sublease approximately
25%
(subject to annual adjustment), as amended, of the Company’s primary office space aforementioned (the WCG Sublease). The Company remains the primary obligor under the WCG Sublease and records all sublease income as a reduction of rent expense in the condensed consolidated statements of operations. WCGT paid an initial security deposit of approximately
$0.3 million
(the WCG Security Deposit). Effective April 1, 2018, the WCG Sublease was reassigned from WCGT to WCG Cares, whereby WCG Cares agreed to pay the Company
20%
of the overall lease payment under the 2015 Lease. All terms and conditions remain the same as the original WCG Sublease. The remaining WCG Security Deposit totaled approximately
$0.2 million
was repaid to WCGT in June 2018. The Company terminated the WCG Sublease in the fourth quarter of 2018. There were
no
sublease payments received pursuant to the WCG Sublease during the three and six months ended
June 30, 2019
, and
$40,000
sublease payments were received during the three and six months ended June 30, 2018.
Leased Space
In August 2017, the Company entered into a manufacturing and supply agreement with an outside supplier for non-recoverable expenses incurred by the supplier during non-commercial periods for a term of one year from August 2017. This agreement was further renewed by both parties to cover the period from August 2018 to late 2019. Under the agreement, the supplier provides a dedicated packaging space for the Company with a fixed monthly cost. The Company determined that this dedicated space is accounted for as an operating lease under
ASC 842 Leases.
Supplemental Financial Statement Information
|
|
|
|
|
|
Lease Assets and Liabilities (in thousands)
|
|
June 30, 2019
|
|
Operating right-of-use assets
|
|
$
|
483
|
|
Operating lease liabilities
|
|
580
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
Lease Cost (in thousands)
|
|
Classification
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Operating lease expense
|
|
Research and development
|
|
$
|
83
|
|
|
$
|
30
|
|
|
$
|
165
|
|
|
$
|
73
|
|
Operating lease expense
|
|
General and administrative
|
|
103
|
|
|
$
|
66
|
|
|
212
|
|
|
$
|
181
|
|
Total
|
|
|
|
$
|
186
|
|
|
$
|
96
|
|
|
$
|
377
|
|
|
$
|
254
|
|
|
|
|
|
|
Lease Term and Discount Rate
|
|
June 30, 2019
|
|
Weighted average remaining lease term (in years)
|
|
0.73
|
|
Weighted average discount rate
|
|
12
|
%
|
|
|
|
|
|
|
Maturity of Operating Lease Liabilities (in thousands)
|
|
June 30, 2019
|
|
Year ending December 31, 2019
|
|
$
|
408
|
|
Year ending December 31, 2020
|
|
201
|
|
Total lease payments
|
|
609
|
|
Less: imputed interest
|
|
(29
|
)
|
Total
|
|
$
|
580
|
|
|
|
|
|
|
|
Maturity of Operating Lease Liabilities under the 2015 Lease (in thousands)
|
|
December 31, 2018
|
|
Year ending December 31, 2019
|
|
$
|
777
|
|
Year ending December 31, 2020
|
|
201
|
|
Total
|
|
$
|
978
|
|
|
|
|
|
|
|
Other information (in thousands)
|
|
Six Months Ended
June 30, 2019
|
Cash paid for amounts included in the measurement of lease liabilities:
|
|
|
Operating cash flows from operating leases
|
|
$
|
427
|
|
Contingencies
From time to time the Company may be involved in various lawsuits, legal proceedings or claims that arise in the ordinary course of business. There were
no
claims or actions pending against the Company as of
June 30, 2019
and
December 31, 2018
, which management believes would have, individually or in the aggregate, a material adverse effect on its business, liquidity, financial position, results of operations or cash flows. However, litigation is subject to inherent uncertainties and an adverse result in these or other matters may arise from time to time that may harm the Company’s business.
Intellectual Property Rights
In 2014, Private Evofem entered into an amended and restated license agreement with Rush University (the Rush License Agreement) pursuant to which Rush University granted Private Evofem an exclusive, worldwide license of certain patents and know-how, related to its MVP-R technology authorizing Private Evofem to make, distribute and commercialize products and processes for any and all therapeutic, prophylactic and/or diagnostic uses, including, without limitation, use for female vaginal health and/or birth control.
The Company may be obligated to pay an earned royalty based upon a percentage of net sales in the range of mid-single digits. Commencing on January 1 of year three after a product has received regulatory approval and has been introduced to market, the Company may become obligated to pay minimum annual royalties, to the extent the earned royalty or sublicensing fees, as applicable, do not exceed the minimum annual royalties.
In October 2015, the Company's subsidiaries, ENA and EP entered into separate sublicense agreements (the Sublicenses) with WomanCare Global Trading CIC (WCGCIC) for a contraceptive vaginal ring. In August 2016, ENA, EP and WCGCIC entered into a side letter to modify the timing of the 2016 and 2017 payments due under the Sublicenses. On an aggregate basis, consideration under the Sublicenses consisted of (i) payments or potential payments to the licensor of (a) an upfront payment of
$10.0 million
, (b) potential regulatory and commercial milestone payments up to
$32.0 million
, (c) potential royalty payments on net product sales and (d) potential royalty payments on net sales of an equivalent generic product and (ii)
$5.0 million
in annual sublicense fees through October 1, 2019 to WCGCIC. In December 2016, under the terms of the Sublicenses, ENA and EP provided 90-days written notice of termination of the Sublicenses to WCGCIC, which period concluded on March 28, 2017.
During the quarter ended March 31, 2019, the Sublicenses were reassigned to WCG Cares, upon which, the unpaid sublicense fees ceased accruing interest and all accrued sublicense fees and interest expense of
$1.3 million
were transferred and became payable to WCG Cares. As of
June 30, 2019
and
December 31, 2018
, the Company had accrued sublicense fees and accrued interest expense on unpaid sublicense fees of approximately
$1.1 million
and
$0.2 million
, respectively, for both periods, which are included in the condensed consolidated balance sheets. See
Note 7 – Related-party Transactions
for a summary of the Company’s transactions with WCGCIC, WomanCare Global International, a non-profit organization registered in England and Wales (WCGI) and related entities, and WCG Cares.
7. Related-party Transactions
Consulting Agreements
Effective April 1, 2016, Private Evofem entered into a
one
-year consulting agreement (the 2016 Consulting Agreement) with Thomas Lynch, the chairman of the Company’s board of directors. Pursuant to the 2016 Consulting Agreement, Mr. Lynch provides consulting services with respect to investor relations and business development activities as requested from time to time. Pursuant to the 2016 Consulting Agreement, Mr. Lynch (i) received compensation of approximately
$0.4 million
, including
$0.1 million
related to his board services, (ii) received a stock option for the purchase of
3,850
shares of common stock with an exercise price of
$46.36
per share, which vest over a
one
-year period through March 1, 2017 and (iii) was issued a restricted stock unit (RSU) for the rights to
2,566
shares of common stock. Upon the closing of the Merger, Mr. Lynch agreed to cancel all of his unvested RSU received pursuant to the 2016 Consulting Agreement. See
Restricted Stock Units
discussion in
Note 12 — Stock-based Compensation
for the accounting treatment for Mr. Lynch’s RSU granted in 2016. On July 2, 2018, under the Amended and Restated 2014 Plan (as defined below), the Company issued
150,000
RSUs to Mr. Lynch in consideration for certain consulting services provided to the Company in connection with the 2016 Consulting Agreement. The RSUs were fully vested on the grant date.
In August 2017, Private Evofem and Mr. Lynch entered into a
two
-year consulting agreement (the 2017 Consulting Agreement), which was effective as of April 1, 2017. The 2017 Consulting Agreement expired in accordance with its terms on March 31, 2019. This 2017 Consulting Agreement provided for (i) annual compensation of
$0.4 million
, including
$0.1 million
related to his board services and (ii) a stock option for the purchase of
6,416
shares of common stock that was to vest quarterly through March 31, 2018, which remained unissued at the time of the Merger. On March 12, 2018, the Company issued a stock option for the purchase of
225,000
shares of the Company's common stock with an exercise price of
$7.29
per share in lieu of the unissued stock option pursuant to the 2017 Consulting Agreement, of which
125,000
shares vested on the grant date and the remaining shares vested in a series of twelve successive equal monthly installments upon completion of each additional month of service measured from April 1, 2018. The option was awarded in connection with Mr. Lynch's consulting services for the Company for the fiscal years 2016 to 2018. On July 31, 2018, the Company issued additional stock options for the purchase of
85,500
shares of the Company's common stock with an exercise price of
$2.10
per share pursuant to the 2017 Consulting Agreement, which shares will vest in a series of 36 successive equal monthly installments upon completion of each additional month of service measured from the grant date. In addition, on July 31, 2018, the Compensation Committee, with the authorization of the board of directors, approved a one-time, discretionary cash bonus award to Mr. Lynch in the amount of
$50,000
.
Effective April 1, 2019, the Company entered into a new
two
-year consulting agreement with Mr. Lynch (the 2019 Consulting Agreement). The 2019 Consulting Agreement provides for (i) annual compensation of
$0.4 million
, including
$0.1 million
related to Mr. Lynch’s board services, (ii) an annual grant of
150,000
RSUs, which will vest quarterly over one year from April 1, 2019 and (iii) an annual bonus of up to 100% of Mr. Lynch’s annual consulting fees based upon the achievement of the Company’s corporate goals and objectives as determined by and subject to approval of the board of directors.
Consulting fees incurred under the 2017 and 2019 Consulting Agreements were approximately
$0.3 million
and
$0.1
million for the three months ended June 30, 2019 and 2018, respectively, and
$0.4 million
and
$0.1 million
for the six months ended June 30, 2019 and 2018, respectively. As of
June 30, 2019
and December 31, 2018, accrued compensation, excluding board fees, owed to Mr. Lynch was
$0.1 million
for both periods.
Transactions with WCGI and Related Entities
From 2009 to 2016, Ms. Saundra Pelletier was the founding CEO of WCGI. In February 2013, Private Evofem and WCGI formed an alliance (the WCGI Alliance) and Ms. Pelletier also became Private Evofem’s CEO. Concurrent with the forming of the WCGI Alliance, Private Evofem and WCGI entered into (i) a service agreement to which the companies shared resources and employees and (ii) a
three
-year grant agreement under which the Private Evofem provided funding of
$4.0 million
per year to WCGI.
From 2011 to 2017, Ms. Pelletier served as a director of the board of WCGT, a WCGI subsidiary. As described in
Note 6 — Commitments and Contingencies
, (i) effective in February 2015, Private Evofem and WCGT, entered into a sublease for office space, which was terminated and reassigned to WCG Cares effective April 1, 2018, and (ii) in October 2015, (a) Private Evofem, through its wholly-owned subsidiaries, entered into two sublicense agreements whereby Private Evofem was responsible for paying
$5.0 million
in annual sublicense fees, net of amounts paid under the grant agreement during 2015, to WCGCIC, also a WCGI affiliate, and (b) the service and grant agreements were canceled.
Effective January 2016, Private Evofem and WCGI entered into a shared-services agreement (the SSA), which replaced the prior service agreement. Under the terms of the SSA, Private Evofem and WCGI cross charge the other company’s services provided by each entity on behalf of the other. The SSA also allows for netting of due to and due from shared-services
fees. Services provided under the SSA on behalf of WCGI were immaterial for the three months ended June 30, 2018, and the three and six months ended
June 30, 2019
. Such amounts were approximately
$0.1 million
for the six months ended June 30,
2018
. Net shared-services due to the Company were immaterial as of
June 30, 2019
and December 31,
2018
. In July 2019, the SSA was terminated.
The following table summarizes receivables and payables related to the Company's transactions with WCGI related entities for the periods indicated (in thousands). Such amounts were immaterial as of June 30, 2019 and for the
three and six months ended June 30, 2019
. All accrued sublicense fees and interest expense related to the Sublicenses as of December 31, 2018 became payable to WCG Cares during the first quarter of 2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2018
|
|
Receivables
|
|
|
|
$
|
3
|
|
Payables
|
|
|
|
$
|
1,291
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2018
|
|
Six Months Ended June 30, 2018
|
Payments
|
|
$
|
883
|
|
|
$
|
883
|
|
Expenses
|
|
$
|
28
|
|
|
$
|
59
|
|
Transactions with WCG Cares
In 2013, WCG Cares, a 501(c)(3) nonprofit organization, was incorporated under the laws of the State of California. Its primary purpose is to directly engage in and/or fund the development and implementation of programs that promote reproductive health, education, research and increased access to high-quality, innovative and affordable reproductive healthcare and healthcare products around the world. Ms. Pelletier served as the CEO and President of WCG Cares from 2013 to November 2017. She became a member of its board in November 2017 and served as chair of its board of directors from November 2017 to May 2018. Additionally, Mr. Justin J. File served as WCG Cares' Chief Financial Officer from November 2017 to May 2018. Dr. Kelly Culwell served as WCG Cares' Chief Medical Officer from November 2017 to December 2018. Dr. Culwell also became a director of its board in January 2019 with a term of
three years
until December 31, 2021. See shared-services agreement discussion below.
The Company agreed to be a corporate sponsor of WCG Cares’ U.S. education campaign, the Tryst Network, which officially launched in February 2018. The Company paid WCG Cares a one-time payment of
$0.3 million
in March 2018 in connection with this corporate sponsorship of the Tryst Network. During the second quarter of 2018, the Company ceased its corporate sponsorship of the Tryst Network.
In March 2018, the Company and WCG Cares entered into a shared-services agreement (the Cares Shared Services Agreement). Under the terms of the Cares Shared Services Agreement, the Company and WCG Cares cross charge services provided by each entity (or its subsidiaries) on behalf of the other. The Cares Shared Services Agreement also allows for netting of due to and due from shared-services fees. Services provided under the Cares Shared Services on behalf of WCG Cares were approximately
$0.1 million
for both the three and six months ended June 30, 2018, and immaterial for both the three and six months ended
June 30, 2019
. As of
June 30, 2019
and December 31, 2018, net shared-services due to the Company were immaterial for both periods. In July 2019, the Company provided a notice of termination to WCG Cares to terminate the Cares Shared Services Agreement effective September 2019.
The following table summarizes receivables, payables, payments and expenses related to the Company's transactions with WCG Cares for the periods indicated (in thousands). Such amounts were immaterial as of December 31, 2018, for the three months ended June 30, 2018, and for the
three and six months ended June 30, 2019
.
|
|
|
|
|
|
|
|
June 30, 2019
|
|
Receivables
|
|
$
|
—
|
|
Payables
|
|
$
|
1,291
|
|
|
|
|
|
|
Six Months Ended June 30, 2018
|
Payments
|
|
$
|
300
|
|
Operating expense
|
|
$
|
126
|
|
Variable Interest Entity Considerations
Due to shared management and numerous agreements between the Company and WCGI and the Company and WCG Cares, management reviewed its relationship with both WCGI and its subsidiaries and WCG Cares in accordance with the authoritative guidance for variable interest entities within ASC 810 -
Consolidation
. The Company concluded that due to WCGI’s and WCG Cares’ status as not-for-profit entities, the scope exception from qualifying as a variable interest entity was met and, therefore, the Company is not required to consolidate WCGI or WCG Cares.
8. Convertible Preferred Stock
Immediately prior to the Merger, as described in
Note 1- Description of Business and Basis of Presentation
, each share of Private Evofem’s capital stock (other than Private Evofem’s Series D), including its Series A convertible preferred stock, Series B convertible preferred stock, Series C-1 convertible preferred stock and Series C convertible preferred stock was converted into shares of the Company's common stock on a one-for-one basis effecting the Exchange Ratio and the Reverse Stock Split for an aggregate of
1,027,079
shares. In addition, each share of Private Evofem’s Series D was converted into approximately
85,987
shares of the Company’s common stock for an aggregate of
6,878,989
shares. As of
June 30, 2019
and December 31, 2018,
no
shares of convertible preferred stock were issued and outstanding.
Dividends on the Series D were payable (i) upon conversion, (ii) redemption or (iii) liquidation. As such, although the Company’s board of directors had not declared dividends, the Company accrued dividends on the Series D. Upon closing of the Merger, the Company paid cash dividends of
$0.2 million
for the accrued dividends only for the period of January 6, 2018 to the Closing Date and the accrued and unpaid dividends of
$5.2 million
as of December 31, 2017 were reclassified to additional paid-in capital upon conversion of
80
shares of Series D into common stock.
The designated, issued and outstanding shares of convertible preferred stock, by series, as of December 31, 2017 were as follows (aggregate liquidation amount and proceeds, net of issuance costs, in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
.
|
Private Evofem and Cosmederm entered a promissory note during 2015, which was amended in July 2016 in conjunction with the Private Evofem’s Series D financing (the Amended Cosmederm Note). Cosmederm assigned the Amended Cosmederm Note with the then outstanding principal balance of
$10.0 million
to WIM. As a condition to closing the Private Evofem’s Series D, WIM immediately converted
$5.0 million
of the Amended Cosmederm Note into
10
shares of the Private Evofem’s Series D and canceled the remaining
$5.0 million
.
Series D
In July 2016, Private Evofem entered into a Series D purchase agreement with WIM, which was subsequently amended in July 2017 to increase the number of authorized preferred stock for issuance (as amended, the Series D SPA). The Series D SPA authorized the issuance and sale of an aggregate of
80
shares of Series D, which was sold at an issuance price per share of
$500,000
. WIM also received the right to receive warrant shares to be determined in the next equity financing (Warrant Rights). See
Warrant Rights
discussion below.
Warrant Rights
Upon completion of the Merger, Private Evofem’s Series D Warrant Rights were assumed by the Company and exchanged for an aggregate of
three
shares of the Company's common stock and the WIM Warrants to purchase up to
2,000,000
shares of the Company's common stock. The shares of common stock issued in connection with the WIM Warrants may not be transferred separately from the WIM Warrants. The WIM Warrants became exercisable on January 17, 2019 and remain exercisable until the earlier of January 18, 2022 or immediately prior to the completion of an acceleration event, as defined therein, and have an exercise price of
$8.35
per share.
The Company determined that the WIM Warrants are free standing financial instruments and classified as equity in accordance with ASC 480—
Distinguish Liabilities from Equity.
To determine the fair value of the WIM Warrants, the Company utilized the BSM option-pricing model, where the warrants’ exercise price was determined based on a Monte Carlo simulation. The valuations resulted in a concluded fair value of the WIM Warrants of
$14.1 million
as of January 18, 2018, which was recorded as additional paid-in capital in the condensed consolidated balance sheet.
On February 5, 2019, the Company entered into letter agreements (the Repricing Letter Agreements) with WIM and certain other holders of outstanding warrants to purchase common stock of the Company by exercising certain outstanding warrants. Upon execution of the Repricing Letter Agreements, investment funds affiliated with WIM exercised certain WIM Warrants to purchase an aggregate of
1,525,000
shares of common stock at a reduced exercise price of
$2.64
per share. The Company determined that the incremental fair value as a result of the modification to these WIM Warrants from change of the exercise price was approximately
$1.4 million
, which was recorded as change in fair value of warrants in the condensed consolidated statement of operations for the six months ended June 30, 2019.
On June 10, 2019, upon the Second Closing of the Private Placement as discussed at
Note 10- Private Placement
, the remaining WIM Warrants to purchase up to
475,000
shares of common stock were canceled.
9. Public Offering
On May 24, 2018, the Company completed an underwritten public offering (the Offering), whereby the Company issued
7,436,171
shares of common stock at a public offering price of
$4.69
per share and pre-funded warrants to purchase
1,063,829
shares of common stock at a public offering price of
$4.68
per warrant and an exercise price of
$0.01
per share. Each share of common stock and each pre-funded warrant was issued together with a common warrant to purchase one-fifth of a share of the Company's common stock at a public offering price of
$0.01
per warrant and an exercise price of
$7.50
per share. An aggregate of
8,500,000
common warrants were issued in connection with the Offering and are exercisable to purchase an aggregate of
1,700,000
shares of common stock. The common warrants issued to the three funds affiliated with WIM that participated in the Offering were issued as a unit with one share of common stock totaling three unit shares in the aggregate (the Unit Shares). Except with respect to the Unit Shares, the shares of common stock, pre-funded warrants and common warrants are separately transferable. The Company determined that the pre-funded warrants and common warrants are free standing financial instruments and equity classified in accordance with ASC 480-
Distinguish Liabilities from Equity
.
The Company received proceeds from the Offering of approximately
$37.5 million
, net of underwriting discounts and commissions, but before deducting the estimated offering costs of
$1.5 million
. The estimated offering costs were recorded as contra additional-paid in capital in the condensed consolidated balance sheet. The common stock and warrants issued in the Offering were registered pursuant to a registration statement on Form S-1 filed with the SEC on May 16, 2018 and declared effective on May 21, 2018.
On June 26, 2018, the Company issued an additional
912
common warrants to purchase approximately
182
shares of common stock upon an underwriter's exercise of its overallotment option. The offering price and exercise price were the same as the common warrants issued on May 24, 2018. The net proceeds received from this issuance were immaterial.
In February 2019, per the terms of the Repricing Letter Agreements, WIM and other holders of common warrants issued in the Offering exercised their common warrants to purchase an aggregate of
851,062
shares of common stock at a reduced exercise price of
$2.64
per share. The Company determined that the incremental fair value as a result of the modification to these common warrants issued in the Offering from change of the exercise price was
$0.5 million
, which was recorded as change in fair value of warrants in the condensed consolidated statement of operations for the six months ended June 30, 2019.
10. Private Placement
On April 10, 2019, the Company entered into a Securities Purchase Agreement with PDL BioPharma, Inc., a Delaware corporation (PDL), funds discretionally managed by Invesco Ltd. (Invesco) and funds managed by WIM (collectively, the Purchasers), providing for the issuance and sale to the Purchasers of an aggregate of up to
$80 million
of the Company’s
common stock, par value
$0.0001
per share (the Shares) at a purchase price of
$4.50
per share, and warrants to purchase shares of common stock with an exercise price of
$6.38
per share (collectively, the Securities) in a private placement (the Private Placement) to be funded in up to two separate closings.
The first closing was completed on April 11, 2019 (the First Closing), pursuant to which the Company (i) issued and sold to PDL
6,666,667
shares of its common stock and warrants to purchase up to
1,666,667
shares of common stock (the First Closing Warrants) and (ii) provided to the Purchasers an option, but not an obligation, from the Company to issue and sell to each Purchaser the shares of common stock and warrants as specified in the aforementioned Securities Purchase Agreement during the period beginning on April 11, 2019 and ending on June 10, 2019 (the Purchase Rights). The total consideration for the First Closing was
$30 million
.
The second closing was completed on June 10, 2019 (the Second Closing), pursuant to which the Company issued and sold to PDL, Invesco and WIM (i)
6,666,667
,
2,222,222
, and
2,222,223
shares of its common stock, respectively and (ii) warrants to purchase up to
1,666,667
,
555,556
and
555,556
shares of common stock (the Second Closing Warrants), respectively, for an aggregate purchase price of
$50 million
. Shares of common stock issued to WIM included one voting share issued in connection with the issuance of its warrants.
The Company's stockholders approved the Private Placement at its 2019 Annual Meeting of Stockholders held on June 5, 2019 (the Approval Date).
The warrants have a
seven
(7) year term and will become exercisable at any time on or after the date that is
six
(6) months following their respective issuance dates. The Company determined the First Closing Warrants were free standing financial instruments and liability classified in accordance with ASC 480-
Distinguish Liabilities from Equity
(ASC 480) due to the requirement to obtain stockholder approval pursuant to Nasdaq Listing Rule 5635(b). The Company utilized the BSM option-pricing model to calculate the fair value of warrants at issuance and on the Approval Date for the First Closing Warrants, and recorded the following in the condensed consolidated financial statements: (i)
$3.6 million
warrant liability at issuance; (ii)
$3.3 million
change in fair value of warrants in the condensed consolidated statement of operations as a result of mark-to-market on the Approval Date; and (iii)
$6.9 million
reclassification from warrant liability to additional paid-in capital in the condensed consolidated balance sheet on the Approval Date.
The Second Closing Warrants were determined to be free standing financial instruments and equity classified in accordance with ASC 815-
Derivatives and Hedging
(ASC 815). The Company utilized the BSM option-pricing model to calculate the fair value of warrants at issuance and recorded an estimated fair value of
$12.7 million
as additional paid-in capital in the condensed consolidated balance sheet.
The Company also determined the Purchase Rights were free standing financial instruments and liability classified in accordance with ASC 480 due to the stockholder approval provision noted above. As described in
Note 5- Fair Value Financial Instruments
, the Company utilized a combination of a lattice model and a BSM option-pricing model to calculate the fair value of the Purchase Rights at issuance and on the Approval Date. The Company recorded the following in the condensed consolidated financial statements: (i)
$3.2 million
purchase rights liability at issuance for the Purchase Rights provided to PDL; (i)
$0.7 million
loss on issuance of purchase rights at issuance in the condensed consolidated statement of operations for the Purchase Rights provided to Invesco and WIM; (iii)
$19.6 million
change in fair value of purchase rights in the condensed consolidated statement of operations as a result of mark-to-market on the Approval Date; and (iii)
$22.8 million
reclassification from purchase rights liability to additional paid-in capital in the condensed consolidated balance sheet on the Approval Date.
Upon completion of the First and Second Closing, the Company received proceeds of approximately
$28.2 million
and
$47.2 million
, net of
$1.8 million
and
$2.8 million
in advisory fees to financial advisors, respectively, and expects to use these proceeds for clinical research and development purposes, including resubmission of the New Drug Application (NDA) for Amphora with the FDA, pre-commercialization activities, and for general corporate purposes.
Additionally, upon completion of the Second Closing, the previously issued WIM Warrants and Reload Warrants to purchase up to
475,000
shares and
1,188,029
shares of common stock, respectively, were canceled. See
Note 11- Stockholders' Equity (Deficit)
for additional details on the Reload Warrants. The Company included such cancellation in valuing the Purchase Rights described above.
11. Stockholders' Equity (Deficit)
Warrants
As referenced in
Note 8- Convertible Preferred Stock
and
Note 9- Public Offering
, warrants to purchase an aggregate of
2,376,062
shares of common stock were exercised at an exercise price of
$2.64
per share in February 2019 per the Repricing Letter Agreements. The Company received gross proceeds of approximately
$6.3 million
from these exercises.
On February 8, 2019 and per the terms of the Repricing Letter Agreements, the Company issued warrants to purchase up to
1,188,029
shares of the Company's common stock (Reload Warrants) to the holders party to the Repricing Letter Agreements and have an exercise price of
$5.20
per share. The Company determined the Reload Warrants are free standing financial instruments and equity classified in accordance with ASC 480— Distinguish Liabilities from Equity. Since these Reload Warrants were issued in addition to the reduced exercise price to induce Holders of WIM Warrants and common warrants to exercise their warrants, the Company determined the fair value of the Reload Warrants was also the incremental fair value as a result of the modification to the WIM warrants and common warrants exercised. To determine the fair value of the Reload Warrants, the Company utilized the BSM option-pricing model, which resulted in an estimated fair value of the Reload Warrants of
$2.5 million
, which was recorded as additional paid-in capital in the condensed consolidated balance sheet and change in fair value of warrants in the condensed consolidated statement of operations. Upon completion of the Second Closing of the Private Placement as discussed at
Note 10- Private Placement
, all Reload Warrants were canceled.
As referenced in
Note 10- Private Placement
, warrants to purchase an aggregate of
4,444,446
were issued in connection with the Private Placement at an exercise price of
$6.38
per share in April and June 2019.
As of
June 30, 2019
, warrants to purchase up to
6,369,270
shares of the Company's common stock remain outstanding at a weighted average exercise price of
$5.50
per share. These warrants are summarized below:
|
|
|
|
|
|
|
|
|
|
|
|
|
Type of Warrants
|
|
Underlying Common Stock to be Purchased
|
|
Exercise Price
|
|
Issue Date
|
|
Exercise Period
|
Common Warrants
|
|
2,020
|
|
|
$
|
67.71
|
|
|
January 25, 2010
|
|
January 25, 2010- February 25, 2020
|
Common Warrants
|
|
878
|
|
|
$
|
51.24
|
|
|
March 30, 2012
|
|
March 30, 2012 to March 30, 2022
|
Common Warrants
|
|
1,171
|
|
|
$
|
51.24
|
|
|
August 17, 2012
|
|
August 17, 2012 to July 17, 2022
|
Common Warrants
|
|
7,806
|
|
|
$
|
3.69
|
|
|
June 11, 2014
|
|
June 11, 2014 to June 11, 2024
|
Pre-funded Warrants
|
|
1,063,829
|
|
|
$
|
0.01
|
|
|
May 24, 2018
|
|
May 24, 2018 until shares are exercised
|
Common Warrants
|
|
848,938
|
|
|
$
|
7.50
|
|
|
May 24, 2018
|
|
May 24, 2018 to May 24 2025
|
Common Warrants
|
|
182
|
|
|
$
|
7.50
|
|
|
June 26, 2018
|
|
June 26, 2018 to June 26, 2025
|
Common Warrants
|
|
1,666,667
|
|
|
$
|
6.38
|
|
|
April 11, 2019
|
|
October 11, 2019 to October 11, 2026
|
Common Warrants
|
|
2,777,779
|
|
|
$
|
6.38
|
|
|
June 10, 2019
|
|
December 10, 2019 to December 10, 2026
|
Total
|
|
6,369,270
|
|
|
|
|
|
|
|
Common Stock
Effective January 17, 2018 and in connection with the Merger, the Company amended and restated its certificate of incorporation, under which the Company is currently authorized to issue up to
300,000,000
shares of common stock,
$0.0001
par value per share, and
5,000,000
shares of preferred stock,
$0.0001
par value per share.
On February 5, 2019, the Company issued
2,376,062
shares of common stock upon the exercise of outstanding warrants in connection with the Repricing Letter Agreements. On February 8, 2019, the Company issued
3
shares of common stock to each of the investment funds affiliated with WIM in connection with the issuance of Reload Warrants. These shares issued to funds affiliated with WIM may not be transferred separately from the Reload Warrants issued to WIM.
On February 25, 2019, the Company issued
470,500
shares of restricted stock pursuant to the Amended and Restated 2014 Plan (as defined below) and are further discussed in
Note 12 - Stock-based Compensation
.
The Company issued
6,666,667
and
11,111,112
shares of common stock on April 11, 2019 and June 10, 2019, respectively, in connection with the First and Second Closing of the Private Placement as discussed in
Note 10- Private Placement
.
Common Stock Reserved for Future Issuance
Common stock reserved for future issuance is as follows in common equivalent shares as of
June 30, 2019
:
|
|
|
|
Common stock issuable upon the exercise of stock options outstanding
|
6,134,179
|
|
Common stock issuable upon release of restricted stock units
|
151,500
|
|
Common stock issuable upon the exercise of common stock warrants
|
6,369,270
|
|
Common stock available for future issuance under the 2019 ESPP
|
500,000
|
|
Common stock available for future issuance under the Amended and Restated 2014 Plan
|
636,944
|
|
Common stock available for future issuance under the Inducement Plan
|
156,000
|
|
Total common stock reserved for future issuance
|
13,947,893
|
|
12. Stock-based Compensation
Equity Incentive Plans
The following table summarizes stock-based compensation expense related to stock options, restricted stock awards (RSAs) and RSUs granted to employees and non-employee directors included in the condensed consolidated statements of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Research and development
|
$
|
369
|
|
|
$
|
2,365
|
|
|
$
|
657
|
|
|
$
|
2,595
|
|
General and administrative
|
2,146
|
|
|
8,298
|
|
|
3,820
|
|
|
8,756
|
|
Total
|
$
|
2,515
|
|
|
$
|
10,663
|
|
|
$
|
4,477
|
|
|
$
|
11,351
|
|
In September 2012, Private Evofem adopted the 2012 Equity Incentive Plan (the 2012 Plan) that provides for the issuance of RSAs, RSUs, or non-qualified and incentive common stock options to its employees, non-employee directors and consultants, from its authorized shares. In general, the options expire
ten
years from the date of grant and generally vest either (i) over a
four
-year period, with
25%
exercisable at the end of one year from the employee’s hire date and the balance vesting ratably thereafter or (ii) over a
three
-year period, with
25%
exercisable at the grant date and the balance vesting ratably thereafter. Upon completion of the Merger, Private Evofem's 2012 Plan was assumed by the Company and awards outstanding under the 2012 Plan became awards for the Company's common stock. Effective as of the Merger, no further awards may be issued under the 2012 Plan.
On September 15, 2014, Neothetics’ board of directors adopted, and stockholders approved, the 2014 Equity Incentive Plan (the 2014 Plan). In May 2018, the Company's board of directors adopted, and stockholders approved, the amendment and restatement of the 2014 Plan of the Company (the Amended and Restated 2014 Plan), that, among other things, would increase the number of authorized shares under the 2014 Plan from
749,305
to an aggregate of
5,300,000
shares. On November 28, 2018, the Company's board of directors approved, subject to stockholder approval, and recommended its stockholders approve at the 2019 Annual Meeting, an additional
2,500,000
authorized shares reserved for issuance under the Amended and Restated 2014 Plan to an aggregate of
7,800,000
shares, including the Evergreen Shares discussed below. Such approval was obtained at the 2019 Annual Meeting held on June 5, 2019. Per the terms of the Amended and Restated 2014 Plan, the shares reserved will automatically increase on each January 1 through 2024, by an amount equal to the smaller of (1)
4%
of the number of shares of common stock issued and outstanding on the immediately preceding December 31; or (2) an amount determined by our board of directors. This provision resulted in an additional
1,034,689
shares (Evergreen Shares) added to the total number of authorized shares on January 1, 2019. As of
June 30, 2019
, there were
636,944
shares available to grant under the Amended and Restated 2014 Plan.
On July 24, 2018, upon the recommendation by the Compensation Committee, the board of directors adopted the Evofem Biosciences, Inc. 2018 Inducement Equity Incentive Plan (the Inducement Plan), pursuant to which the Company reserved
250,000
shares for the issuance of equity awards under the Inducement Plan. The only persons eligible to receive awards under the Inducement Plan are individuals who satisfy the standards for inducement grant recipients under Nasdaq Marketplace Rule 5635(c)(4), generally, a person not previously an employee or director of the Company, or following a
bona fide
period of non-employment, as an inducement material to the individual's entering into employment with the Company. As of
June 30, 2019
, there were
156,000
shares available to grant under the Inducement Plan.
Stock Options
There were
384,000
and
134,375
shares of stock options granted during the
three months ended June 30, 2019
and 2018, respectively, and
443,000
and
3,270,405
shares of stock options granted during the
six months ended June 30, 2019
and 2018, respectively. The stock options granted during the three months ended March 31, 2018 were granted out of the share
reserve increase approved by the board of directors under the Amended and Restated 2014 Plan on March 11, 2018 and were subject to the Company obtaining the requisite stockholder approval that was obtained on May 8, 2018.
T
he stock options granted during the three months ended March 31, 2018 have vesting terms pursuant to which a majority of these options vested as of June 30, 2018, and as a result a significant amount of stock-based compensation expense was recognized during the three months ended June 30, 2018. As of
June 30, 2019
, unrecognized stock-based compensation expense for employees and non-employee stock options was approximately
$8.0 million
, which the Company expects to recognize over a weighted-average remaining period of
2.1
years, assuming all unvested options become fully vested.
Summary of Assumptions
The fair value of stock-based compensation for stock options granted to employees and non-employees was estimated on the date of grant using the BSM option pricing model based on the following weighted-average assumptions for options granted for the periods indicated.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2019
|
|
|
2018
|
|
|
2019
|
|
|
2018
|
|
Expected volatility
|
76.1
|
%
|
|
86.8
|
%
|
|
76.1
|
%
|
|
85.9
|
%
|
Risk-free interest rate
|
2.1
|
%
|
|
2.8
|
%
|
|
2.1
|
%
|
|
2.8
|
%
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
Expected term (years)
|
5.7
|
|
|
5.8
|
|
|
5.7
|
|
|
5.4
|
|
Expected volatility.
The expected volatility assumption is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the biotechnology industry.
Risk-free interest rate.
The risk-free interest rate assumption is based on observed interest rates appropriate for the expected term of the stock option grants.
Expected dividend yield.
The expected dividend yield assumption is based on the fact that the Company has never paid cash dividends and has no present intention to pay cash dividends.
Expected term.
The expected term represents the period options are expected to be outstanding. Because the Company does not have historical exercise behavior, it determines the expected term assumption using the practical expedient as provided for under ASC 718 —
Compensation — Stock Compensation
(ASC 718), which is the midpoint between the requisite service period and the contractual term of the option.
Restricted Stock Awards and Units
In September 2016, under the 2012 Equity Incentive Plan, Private Evofem issued an aggregate of
122,149
shares of restricted stock to members of management (the Management RSAs) with vesting terms subject to the completion of an initial public offering (IPO) by Private Evofem. In October 2016, as previously described in
Note 7 — Related-party Transactions
, Private Evofem issued an RSU for the right to
2,566
shares of common stock to the chairman of the Company’s board of directors (the Chairman RSUs). Upon closing of the Merger, as described in
Note 1 – Description of Business and Basis of Presentation
, the members of management and the chairman of the board of directors agreed to cancel their RSAs and RSUs. As a result, all
122,149
shares of unvested Management RSAs and
2,566
shares of unvested Chairman RSUs were canceled in January 2018, and there was
no
unrecognized stock-based compensation expense related to the canceled Management RSAs and Chairman RSUs.
During the three and six months ended June 30, 2019, under the Amended and Restated 2014 Plan, the Company granted
5,000
and
475,500
shares of RSAs, respectively, to its executive management team and certain non-executive employees, of which
460,500
shares will vest in accordance with the Company's achievement of certain performance milestones in 2019. During the second quarter of 2019, the performance-based RSAs were modified as a result of certain associated performance milestones were revised.
During the three and six months ended June 30, 2019, the Company granted
153,000
shares of RSUs for both periods to its chairman of the Company’s board of directors and one non-employee consultant. No RSAs or RSUs were granted during the three and six months ended June 30, 2018.
For the performance-based RSAs, (i) the fair value of the award was determined on the grant date, (ii) the Company assessed the probability of the individual milestone under the award being achieved and (iii) the fair value of the shares subject to the milestone is expensed over the implicit service period commencing once management believes the performance criteria is probable of being met. On the modification date, the Company applied the share-based payment modification accounting in
accordance with ASC 718. The non-performance based RSAs and RSUs were valued at the fair value on the grant date and the associated expenses will be recognized over the vesting period.
The Company recognized
$0.8 million
and
$1.3 million
stock-based compensation expense during the three and six months ended June 30, 2019, respectively, for RSAs and RSUs. As of
June 30, 2019
, unrecognized stock-based compensation expense related to the unvested RSAs and RSUs was approximately
$1.2 million
, which the Company expects to recognize over a weighted-average remaining period of
0.6
year.
Employee Stock Purchase Plan
In November 2014, Neothetics adopted the 2014 Employee Stock Purchase Plan (the 2014 ESPP), which enables eligible employees to purchase shares of its common stock using their after-tax payroll deductions of up to
15%
of their eligible compensation, subject to certain restrictions.
The 2014 ESPP initially authorized the issuance of
28,333
shares of common stock pursuant to purchase rights granted to employees. The number of shares of common stock reserved for issuance automatically increased on January 1, 2015 and will continue to increase on each January 1 thereafter through January 1, 2024, by the smaller of (a)
1.0%
of the total issued and outstanding shares on the preceding December 31, or (b) a number of shares determined by the board of directors of Neothetics. Therefore, an additional
258,672
shares were added to the total shares authorized under the 2014 ESPP on January 1, 2019. Following completion of the Merger, there was no enrollment in the 2014 ESPP. During the
six months ended June 30, 2019
and 2018, there were
no
shares of common stock purchased under the 2014 ESPP.
On May 7, 2019, the board of directors terminated the 2014 ESPP and approved a new 2019 Employee Stock Purchase Plan (the 2019 ESPP), which was approved by stockholders at the 2019 annual meeting held on June 5, 2019. The 2019 ESPP
enables eligible full-time and part-time employees to purchase shares of the Company’s common stock through payroll deductions of between
1%
and
15%
of eligible compensation during an offering period. A new offering period begins approximately every June 15 and December 15. At the last business day of each offering period, the accumulated contributions made during the offering period will be used to purchase shares. The purchase price is 85% of the lesser of the fair market value of the common stock on the first or the last business day of an offering period. The maximum number of shares of common stock that may be purchased by any participant during an offering period will be equal to
$25,000
divided by the fair market value of the common stock on the first business day of an offering period. The first offering period under the 2019 ESPP commenced on June 17, 2019 and will end on December 15, 2019. During the
six months ended June 30, 2019
, there were
no
shares of common stock purchased under the 2019 ESPP.
As of June 30, 2019, there were
500,000
shares of common stock reserved and available for issuance pursuant to the 2019 ESPP. In addition, the number of shares available for issuance under the 2019 ESPP will increase on January 1 of each year in an amount equal to the lesser of (i)
1,000,000
shares, (ii)
2%
of the shares of common stock outstanding on December 31, or (iii) such lesser number of shares as is determined by the board of directors. The 2019 ESPP is intended to qualify as an employee stock purchase plan within the meaning of Section 423 of the Internal Revenue Code of 1986, as amended (the Code).
The fair value of shares to be issued to employees under the 2019 ESPP is estimated using a BSM option-pricing model at the grant date, which requires the use of subjective and complex assumptions, including (a) the expected stock price volatility, (b) the calculation of the expected term of the award, (c) the risk-free interest rate and (d) the expected dividend yield. The following weighted average assumptions were used in the calculation of fair value of shares under the 2019 ESPP at the grant date for the period indicated:
|
|
|
|
|
Three and Six Months Ended June 30, 2019
|
Expected volatility
|
72.5
|
%
|
Risk-free interest rate
|
2.2
|
%
|
Expected dividend yield
|
—
|
%
|
Expected term (years)
|
0.5
|
|
ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
The terms “we,” “us,” “our,” “Evofem” or the “Company” refer collectively to Evofem Biosciences, Inc. and its wholly-owned subsidiaries, unless otherwise stated. All information presented in this Quarterly Report on Form 10-Q (Quarterly Report) is based on our fiscal year. Unless otherwise stated, references to particular years, quarters, months or periods refer to our fiscal years ending December 31 and the associated quarters, months and periods of those fiscal years.
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our condensed consolidated financial statements and the corresponding notes included elsewhere in this Quarterly Report. For additional context with which to understand our financial condition and results of operations, see the audited consolidated financial statements and accompanying notes contained therein as of December 31, 2018 and 2017 and related notes in our Current Report on Form 10-K as filed with the SEC on March 1, 2019 (the 2018 Audited Financial Statements). This discussion and analysis contains forward-looking statements that involve risks, uncertainties and assumptions. The actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors, including, but not limited to, those set forth under Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2018 as filed with the SEC on March 1, 2019. Unless otherwise defined in this section, the defined terms in this section have the meanings set forth in the 2018 Audited Financial Statements.
Overview
We are a San Diego-based clinical-stage biopharmaceutical company committed to developing and commercializing innovative products to address unmet needs in women’s sexual and reproductive health. We exist to advance the lives of women by developing innovative solutions, such as woman-controlled contraception and potential protection from certain sexually transmitted infections (STIs). Our lead Multipurpose Vaginal pH Regulator (MVP-R
TM
) product candidate, Amphora® (L-lactic acid, citric acid, and potassium bitartrate), is in development for multiple potential indications: prevention of pregnancy, prevention of urogenital transmission of
chlamydia trachomatis
infection (chlamydia) in women and prevention of urogenital transmission of
Neisseria gonorrhoeae
infection (gonorrhea) in women.
Our second Phase 3 clinical trial for Amphora for prevention of pregnancy was an open-label, single-arm trial in approximately 1,400 women in the United States. We refer to this trial as AMPOWER. The last patient for AMPOWER exited the study in November 2018. We reported top-line data from AMPOWER in December 2018, which demonstrated a cumulative pregnancy rate of 13.7% over seven cycles of use (95% CI 9.9, 17.4) in the modified intention-to-treat population (referred to as “typical use”) which met the pre-determined endpoint of this clinical trial. This corresponds to an 86.3% efficacy rate. We plan to resubmit the New Drug Application (NDA) for Amphora to the United States Food and Drug Administration (FDA) in the fourth quarter of 2019. Subject to acceptance and timely approval of the NDA by the FDA, we plan to commercialize Amphora in 2020.
We are also conducting a Phase 2b clinical trial of Amphora for prevention of urogenital transmission of chlamydia (primary endpoint) and gonorrhea (secondary endpoint) in women. We refer to this trial as AMPREVENCE. The primary endpoint of AMPREVENCE is a 40% reduction in the incidence of chlamydia in women treated with Amphora versus placebo. AMPREVENCE was 100% enrolled at approximately 50 study centers in the United States at the end of March 2019; top-line data are expected in the fourth quarter of 2019. We envision our STI program as developing label expansion opportunities to further differentiate Amphora from other currently approved birth control products.
In addition, our pipeline includes an MVP-R gel product candidate for the reduction of recurrent bacterial vaginosis (BV). In our Phase 1 dose-finding trial for this indication, the highest dose formulation of study drug demonstrated reduced vaginal pH for up to seven days following a single administration.
Since inception, we have devoted substantially all of our efforts to develop MVP-R product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. We do not have any approved products and have not generated any revenue from product sales. Although we have released top-line results from the Phase 3 AMPOWER trial for Amphora, the product has not yet been approved for use for prevention of pregnancy or any other targeted indications. Additionally, Amphora and our BV product candidate are still in mid- and early- stage clinical development for the prevention of certain STIs and for recurrent BV, respectively. We do not expect to generate any significant revenues prior to 2020. To finance our current strategic plans, including the conduct of ongoing and future clinical trials, further research and development activities and anticipated pre-commercialization activities in 2019, we will require significant capital. Assuming we have sufficient liquidity, we will incur significantly higher costs in the foreseeable future.
Merger
As previously discussed, on January 17, 2018 (the Closing Date), Neothetics, Inc. (Neothetics), now known as Evofem Biosciences, Inc., completed its reverse merger (the Merger) with privately-held Evofem Biosciences Operations, Inc. (Private Evofem) in accordance with the terms of an agreement and plan of merger and reorganization, dated October 17, 2017. Since
Private Evofem was determined to be the accounting acquirer in connection with the Merger, it recorded Neothetics’ assets and liabilities at fair value as of the Closing Date. To reflect the close of the Merger, we recorded the following items:
|
|
•
|
Recorded Neothetics’ assets and liabilities at fair value as of the Closing Date, including
$1.9 million
of cash and cash equivalents,
$0.5 million
in prepaid and other current assets,
$0.4 million
in current and noncurrent liabilities and
$1.9 million
in 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);
|
|
|
•
|
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 1,027,079 shares of the Company's common stock, effecting the merger exchange ratio of
0.1540
, subject to adjustment for the Reverse Stock Split (as defined below) (the Exchange Ratio) and the 6:1 reverse stock split of our common stock (the Reverse Stock Split), and additional paid-in capital, net of par value, upon conversion to the Company's common stock immediately prior to the closing of the Merger;
|
|
|
•
|
Recorded the cancellation of 122,149 shares of the Company's unvested restricted common stock upon closing of the Merger;
|
|
|
•
|
Recorded the issuance of 3,968,473 shares of the Company'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;
|
|
|
•
|
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 to additional paid-in capital upon conversion of 80 shares of Private Evofem’s Series D redeemable convertible preferred stock (Series D) to 6,878,989 shares of the Company's common stock;
|
|
|
•
|
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;
|
|
|
•
|
Adjusted common stock and additional paid-in capital associated with shares issued in the Merger and Private Placement (as defined below) due to the 6:1 reverse stock split;
|
|
|
•
|
Assumed options to purchase Private Evofem common stock that were outstanding and unexercised as of immediately prior to the Merger (the Private Evofem Plan Options). The Private Evofem Plan Options, were converted into options to purchase 159,325 shares of our common stock, as adjusted for the Exchange Ratio and Reverse Stock Split, at a weighted average price of $56.72; and
|
|
|
•
|
Recorded $20.0 million in proceeds from the sale of 1,614,289 shares of our common stock in a private placement completed immediately after the closing of the Merger.
|
We historically have funded our operations primarily through the sale of our common stock, convertible preferred stock, related-party advances and a note payable from Cosmederm Biosciences, Inc., a prior related party.
Private Placement
As described in
Note 10- Private Placement
, on April 10, 2019, we entered into a Securities Purchase Agreement with PDL BioPharma, Inc., a Delaware corporation (PDL), funds discretionally managed by Invesco and funds managed by WIM (collectively, the Purchasers), pursuant to which we agreed to issue and sell an aggregate of up to $80 million of our common stock, par value $0.0001 per share at a purchase price of $4.50 per share, and warrants to purchase shares of common stock with an exercise price of $6.38 per share in a private placement (the Private Placement) to be funded in up to two separate closings.
The first closing was completed on April 11, 2019 (the First Closing), pursuant to which we (i) issued and sold to PDL
6,666,667
shares of its common stock and warrants to purchase up to
1,666,667
shares of common stock (the First Closing Warrants) and (ii) provided to the Purchasers an option to purchase an aggregate of up to 11,111,112 shares of common stock and warrants to purchase up to an aggregate of 2,777,779 shares of common stock as specified in the aforementioned Securities Purchase Agreement (the Second Closing Securities) during the period beginning on April 11, 2019 and ending on June 10, 2019 (the Purchase Rights). The total consideration for the First Closing was
$30 million
.
The second closing was completed on June 10, 2019 (the Second Closing), pursuant to which we issued and sold the Second Closing Securities to the Purchasers for an aggregate purchase price of $50 million.
Financial Operations Overview
Revenue
To date, we have not generated any revenue from our lead product candidate, Amphora. We do not expect to generate any revenue from any product candidates we develop unless and until we obtain regulatory approval and commercialize our
products or enter into collaborative agreements with third parties. In the future, if Amphora is approved for commercial sale in the United States, we may generate revenue from product sales. If Amphora is approved for commercial sale outside of the United States, we expect to out-license commercialization rights to Amphora to global pharmaceutical companies or other qualified potential partners or enter into collaborations for the commercialization and distribution of Amphora, from which we may generate licensing revenue. However, we cannot forecast which product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and overall capital requirements. We do not expect to commercialize Amphora before 2020, if ever.
Operating Expenses
Research and development expenses
Our research and development expenses primarily consist of costs associated with the clinical and preclinical development of our MVP-R product candidates. Our research and development expenses include:
|
|
•
|
external development expenses incurred under arrangements with third parties, such as fees paid to clinical 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;
|
|
|
•
|
costs to acquire, develop and manufacture clinical trial materials, including fees paid to contract manufacturers;
|
|
|
•
|
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.
|
We expense internal and third-party research and development costs as incurred. The following table summarizes research and development expenses by product candidate (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
Six Months Ended June 30,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Allocated third-party development expenses:
|
|
|
|
|
|
|
|
Amphora for prevention of pregnancy
|
$
|
13
|
|
|
$
|
5,419
|
|
|
$
|
2,134
|
|
|
$
|
14,903
|
|
Chlamydia/gonorrhea
|
2,107
|
|
|
2,538
|
|
|
5,654
|
|
|
3,072
|
|
Bacterial vaginosis
|
—
|
|
|
220
|
|
|
—
|
|
|
431
|
|
Total allocated third-party development expenses
|
2,120
|
|
|
8,177
|
|
|
7,788
|
|
|
18,406
|
|
Unallocated internal research and development expenses:
|
|
|
|
|
|
|
|
Stock-based compensation expenses
|
369
|
|
|
2,365
|
|
|
657
|
|
|
2,595
|
|
Payroll related expenses
|
1,053
|
|
|
674
|
|
|
1,926
|
|
|
1,532
|
|
Outside services costs
|
1,432
|
|
|
452
|
|
|
2,237
|
|
|
789
|
|
Other
|
272
|
|
|
165
|
|
|
527
|
|
|
470
|
|
Total unallocated internal research and development expenses
|
3,126
|
|
|
3,656
|
|
|
5,347
|
|
|
5,386
|
|
Total research and development expenses
|
$
|
5,246
|
|
|
$
|
11,833
|
|
|
$
|
13,135
|
|
|
$
|
23,792
|
|
Completion dates and costs for our clinical development programs can vary significantly for each current and any future product candidate and are difficult to predict. We anticipate we will make determinations as to which programs and product candidates to pursue as well as the most appropriate funding allocations for each program and product candidate on an ongoing basis in response to the results of ongoing and future clinical trials, regulatory developments, and our ongoing assessments as to the commercial potential of each current or future product candidate. With the completion of the clinical phase of AMPOWER, we expect our research and development expenses to decrease in 2019. We will need to raise substantial additional capital in the future to complete clinical development for our current and future product candidates.
The costs of clinical trials may vary significantly over the life of a program owing to the following:
|
|
•
|
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 participating in the trials;
|
|
|
•
|
the number of doses patients receive;
|
|
|
•
|
potential additional safety monitoring or other trials requested by regulatory agencies;
|
|
|
•
|
the phase of development of the product candidate; and
|
|
|
•
|
the efficacy and safety profile of the product candidate.
|
General and administrative expenses
Our general and administrative expenses consist primarily of salaries, benefits, travel, business development expense, stock-based compensation expense, and other related costs for our employees and consultants in executive, administrative, finance and human resource functions. Other general and administrative expenses include facility-related costs not otherwise included in research and development and professional fees for accounting, auditing, tax and legal fees, and other costs associated with obtaining and maintaining our patent portfolio, and conducting commercial assessments for our product candidates.
We expect our general and administrative expenses to increase, specifically sales and marketing expenses, as we hire additional personnel to support the growth of our business and various pre-commercialization activities in early preparation of the anticipated launch of Amphora in 2020, if approved, and as a result of being a publicly-traded company.
Other Income (Expense)
Other income (expense) consists primarily of loss on issuance of warrants, loss on issuance of Purchase Rights, the change in fair value of warrants, the change in fair value of Purchase Rights, and the change in fair value of the Series D 2X liquidation preference, which for each share of Series D is equal to two times the issuance price per share of Series D, plus accrued and unpaid dividends, and became payable upon the closing of the Merger in January 2018.
Loss on issuance of warrants was recognized upon issuance of warrants to investors as they were determined as free-standing financial instruments. The change in fair value of warrants was recognized as a result of the modifications to the warrants from change of the exercise price and mark-to-market for the liability-classified warrants.
Loss on issuance of Purchase Rights was recognized upon issuance the Purchase Rights as they were determined as free-standing liability-classified financial instruments. The change in fair value of Purchase Rights was recognized as a result of mark-to-market for the Purchase Rights.
The Series D 2X liquidation preference expired at the Closing Date, at which time the final fair value of the Series D 2X liquidation preference was estimated. The final change in fair value of the Series D 2X liquidation preference of $0.1 million was recognized within change in fair value of the Series D 2X liquidation preference within the condensed consolidated statements of operations for the quarter ended March 31, 2018. The Series D 2X liquidation preference liability was reclassified to additional paid-in capital within the condensed consolidated balance sheets. Prior to the closing of the Merger, the Series D 2X liquidation preference was revalued at each reporting date and changes in fair value were recognized as increases in or decreases to other income (expense).
Results of Operations
Three Months Ended
June 30, 2019
Compared to Three Months Ended
June 30, 2018
(in thousands):
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
Research and development
|
$
|
5,246
|
|
|
$
|
11,833
|
|
|
$
|
(6,587
|
)
|
(56
|
)%
|
The overall decrease in research and development expenses was mainly due to a $5.8 million decrease in clinical trial costs primarily related to AMPOWER, which completed its clinical phase in December 2018, and AMPREVENCE, which completed its patient enrollment in March 2019. In addition, there was a $2.0 million decrease in noncash stock-based compensation mainly associated with stock options granted in March 2018, for which a significant amount of stock-based compensation was recognized during the second quarter of 2018, offset by the stock-based awards granted subsequent to June 30, 2018. These aggregate decreases were offset by a $0.9 million increase in costs incurred for outside services associated with preparing the Amphora NDA resubmission.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
General and administrative
|
$
|
6,695
|
|
|
$
|
11,409
|
|
|
$
|
(4,714
|
)
|
(41
|
)%
|
The overall decrease in general and administrative expenses was primarily due to a $6.2 million decrease in noncash stock-based compensation mainly associated with the stock options granted in March 2018, for which a significant amount of stock-based compensation was recognized during the second quarter of 2018, offset by stock-based awards granted subsequent to June 30, 2018. This decrease was also partially offset by a $0.5 million increase in payroll related expenses due to increased headcount, a $0.4 million increase in public relations and pre-commercialization marketing related expenses, and a $0.3 million increase in outside services associated with recruiting and consulting services.
Loss on issuance of Purchase Rights
Change in fair value of warrants
Change in fair value of Purchase Rights
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
Loss on issuance of Purchase Rights
|
$
|
(674
|
)
|
|
$
|
—
|
|
|
$
|
(674
|
)
|
(100
|
)%
|
Change in fair value of warrants
|
$
|
(3,315
|
)
|
|
$
|
—
|
|
|
$
|
(3,315
|
)
|
(100
|
)%
|
Change in fair value of Purchase Rights
|
$
|
(19,617
|
)
|
|
$
|
—
|
|
|
$
|
(19,617
|
)
|
(100
|
)%
|
As described in
Note 10- Private Placement
, the loss on issuance of Purchase Rights for the three months ended June 30, 2019 was related to the Purchase Rights we provided to the Purchasers in connection with the First Closing of the Private Placement. No such financial instruments issued during the three months ended June 30, 2018.
The change in fair value of warrants and the change in fair value of Purchase Rights for the three months ended June 30, 2019 were a result of mark-to-market due to their classification change from liability to equity upon stockholder approval of the Private Placement.
Six Months Ended June 30, 2019
Compared to
Six Months Ended June 30, 2018
(in thousands):
Research and development expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
Research and development
|
$
|
13,135
|
|
|
$
|
23,792
|
|
|
$
|
(10,657
|
)
|
(45
|
)%
|
The overall decrease in research and development expenses was due to a $12.7 million decrease in clinical trial costs primarily related to AMPOWER, which completed its clinical phase in December 2018, partially offset by a $2.5 million increase in clinical trial costs related to AMPREVENCE, which completed its enrollment in March 2019. In addition, there was a $1.9 million decrease in noncash stock-based compensation mainly associated with the stock options granted in March 2018, for which a significant amount of stock-based compensation was recognized during the second quarter of 2018, offset by stock-based awards granted subsequent to June 30, 2018. These aggregate decreases were partially offset by a $1.4 million increase in costs incurred for outside services associated with the preparing the Amphora NDA resubmission.
General and administrative expenses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
General and administrative
|
$
|
12,438
|
|
|
$
|
20,436
|
|
|
$
|
(7,998
|
)
|
(39
|
)%
|
The overall decrease in general and administrative expenses was primarily due to a $4.9 million decrease in noncash stock-based compensation mainly associated with the stock options granted in March 2018, for which a significant amount of stock-based compensation was recognized during the second quarter of 2018, offset by stock-based awards granted subsequent to June 30, 2018. There was also a $3.7 million decrease in professional services and personnel costs attributable to the one-time costs associated with the Merger. These decreases were partially offset by a $0.6 million increase in public relations and pre-commercialization marketing related expenses.
Loss on issuance of warrants
Loss on issuance of Purchase Rights
Change in fair value of warrants
Change in fair value of Purchase Rights
Change in fair value of Series D 2X liquidation preference
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30,
|
|
2019 vs. 2018
|
|
2019
|
|
2018
|
|
$ Change
|
% Change
|
Loss on issuance of warrants
|
$
|
—
|
|
|
$
|
(47,920
|
)
|
|
$
|
47,920
|
|
(100
|
)%
|
Loss on issuance of Purchase Rights
|
$
|
(674
|
)
|
|
$
|
—
|
|
|
$
|
(674
|
)
|
(100
|
)%
|
Change in fair value of warrants
|
$
|
(7,755
|
)
|
|
$
|
—
|
|
|
$
|
(7,755
|
)
|
(100
|
)%
|
Change in fair value of Purchase Rights
|
$
|
(19,617
|
)
|
|
$
|
—
|
|
|
$
|
(19,617
|
)
|
(100
|
)%
|
Change in fair value of Series D 2X liquidation preference
|
$
|
—
|
|
|
$
|
(130
|
)
|
|
$
|
130
|
|
(100
|
)%
|
As described in
Note 11- Stockholders' Deficit
, the loss on issuance of warrants for the
six months ended June 30, 2018
was related to the Invesco Warrants issued immediately prior to the Closing Date of the Merger. No such loss was recorded for the
six months ended June 30, 2019
.
As described in
Note 10- Private Placement
, the loss on issuance of Purchase Rights for the six months ended June 30, 2019 was related to the Purchase Rights we provided to the Purchasers in connection with the First Closing of the Private Placement. No such financial instruments issued during the six months ended June 30, 2018. The Change in fair value of Purchase Rights was a result of mark-to-market due to their classification change from liability to equity upon stockholder approval of the Private Placement.
As described in
Note 8- Convertible Preferred Stock
,
Note 9- Public Offering
and
Note 11- Stockholders' Deficit
, there were an aggregate of 2,376,065 shares of common stock issued upon exercise of warrants at a reduced exercise price and issuance of 1,188,029 shares of Reload Warrants in February 2019. The Company determined that the reduction in exercise price and issuance of Reload Warrants to induce the exercise resulted in a modification to the initial warrants terms, which resulted in the recognition of approximately $4.4 million incremental change in fair value of warrants during the first quarter of 2019. There was also a $3.3 million change in fair value of warrants associated with the First Closing Warrants as a result of mark-to-market due to their classification change from liability to equity upon stockholder approval of the Private Placement.
As described in
Note 3- Merger and Related Transactions
, we converted all
80
shares issued and outstanding Series D into the Company' common stock in January 2018 and recognized a change in fair value of the Series D 2X liquidation preference upon a final valuation during the
six months ended June 30, 2018
. Therefore, there was no such change in fair value for the
six months ended June 30, 2019
.
Liquidity and Capital Resources
Overview
We have incurred losses and negative cash flows from operating activities since inception. In February 2019, we received gross proceeds of approximately $6.3 million from the exercise of warrants to purchase 2,376,062 shares of the Company's common stock held by certain shareholders at an exercise price of $2.64 per share. In April and June 2019, we received proceeds of approximately $28.2 million and $47.2 million, net of financial advisory fees, upon completion of the First and Second Closing of the Private Placement, respectively. See
Note 10 - Private Placement
to the financial statements included in this Quarterly Report for details. As of
June 30, 2019
and December 31, 2018, we had
$50.7 million
and $1.3 million in cash and cash equivalents, a working capital of $
34.2 million
and $24.9 million and an accumulated deficit of
$486.7 million
and $433.1 million, respectively.
We anticipate we will continue to incur net losses for the foreseeable future and incur additional costs associated with being a public company. We expect research and development expenses to decrease in 2019 compared to 2018 as the last patient for AMPOWER exited the study in late 2018, and AMPREVENCE was 100% enrolled at the end of March 2019 and the last patient is expected to exit the study in the third quarter of 2019. We expect general and administrative expenses to increase in 2019, specifically sales and marketing expenses, as we hire additional personnel to support the growth of our business and various pre-commercialization activities in preparation for the anticipated launch of Amphora in 2020, if approved. According to management estimates, liquidity resources as of
June 30, 2019
are not sufficient to maintain our planned level of operations for the next 12 months. In addition, the uncertainties associated with our ability to (i) obtain
additional equity financing on terms that are favorable to us, (ii) enter into collaborative agreements with strategic partners and (iii) succeed in our future operations, raise substantial doubt about our ability to continue as a going concern.
The opinion of our independent registered public accounting firm on our audited financial statements as of and for the years ended December 31, 2018 and 2017 contains an explanatory paragraph regarding substantial doubt about our ability to continue as a going concern. Future reports on our financial statements may include an explanatory paragraph with respect to our ability to continue as a going concern. Our unaudited condensed consolidated financial statements as of
June 30, 2019
and for the
three and six months ended June 30, 2019
and 2018 appearing in this Quarterly Report do not include any adjustments relating to the recoverability and classification of recorded asset amounts or amounts of liabilities that might be necessary should we be unable to continue our operations.
If we are not able to obtain the required funding in the near term, through equity financings or other means, or are not able to obtain funding on terms favorable to us, these circumstances will have a material adverse effect on our operations and strategic development plan for future growth. If we cannot successfully raise additional funding and implement our strategic development plan, we may be forced to make reductions in spending, suspend or terminate development programs, extend payment terms with suppliers, liquidate assets where possible, and/or suspend or curtail planned programs. Any of these could materially and adversely affect our liquidity, financial condition and business prospects and we would not be able to continue as a going concern. If we are unable to continue as a going concern, we may have to liquidate our assets and may receive less than the value at which those assets are carried on our financial statements.
Promissory Note
On December 5, 2018, the Company entered into a promissory note (Note) with our CRO for AMPOWER, where the Company agreed to pay the CRO existing invoiced amounts totaling approximately $4.0 million for clinical trial related services which Note had a due date of February 15, 2019. Any matured and unpaid amounts pursuant to this Note bear an annual interest rate of the lesser of 1% per month or the maximum amount permitted by the Laws of the State of Massachusetts.
In late February 2019, the Company amended the Note, which extended the due date to April 15, 2019. In April 2019, the Company paid the Note in full.
Summary Statement of Cash Flows
The following table sets forth a summary of the net cash flow activity for each of the periods set forth below (in thousands):