SAN DIEGO, March 12, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ:EVFM), a clinical-stage biopharmaceutical
company, today reported financial results for the three- and
twelve- month periods ended December 31,
2019.
The Company also announced that the FDA granted conditional
approval for the brand name Phexxi™ (L-lactic acid, citric acid,
potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% on February 25, 2020. With this approval, the
Company will now refer to its Multipurpose Vaginal pH Regulator
(MVP-R™) candidate as Phexxi for the prevention of pregnancy
and EVO100 for the prevention of chlamydia and gonorrhea.
"The Evofem team's exceptional execution in 2019 laid the
groundwork for what will be a transformative year for the Company,"
said Saundra Pelletier, Chief
Executive Officer, Evofem Biosciences. "We are rapidly approaching
the established FDA PDUFA date for our innovative, hormone-free,
investigational contraceptive gel, which we are thrilled to share
is now branded as Phexxi.
"We remain focused on establishing a best-in-class sales force,
initiating pre-commercial activities and continuing to disseminate
compelling new data via conferences and publications. We are
also preparing for other important catalysts that have the
potential to drive future growth, including an end-of-phase 2
meeting with the FDA to discuss the potential path forward for
EVO100 for the prevention of chlamydia and gonorrhea."
Fourth quarter and recent highlights include:
- Resubmitted the NDA for Phexxi for the prevention of pregnancy
and received a six-month review and Prescription Drug User Fee Act
(PDUFA) goal date of May 25, 2020
from the FDA.
- Reported positive, statistically significant top-line results
from the Phase 2b AMPREVENCE study
evaluating EVO100 for the prevention of chlamydia and gonorrhea in
women. The study met its primary and secondary endpoints,
demonstrating a 50% relative risk reduction in chlamydia infection
and a 78% relative risk reduction in gonorrhea infection compared
to placebo.
- Three abstracts from the Phase 3 AMPOWER trial of Phexxi for
prevention of pregnancy accepted for poster presentation at the
American College of Obstetricians and Gynecologists' annual
meeting.
- Appointed Lisa Rarick, M.D.,
F.A.C.O.G., former FDA Division Director for the Division of
Reproductive and Urologic Products, to the Company's Board of
Directors.
- Granted end-of-phase 2 meeting with the FDA to discuss
AMPREVENCE study results and determine the clinical and regulatory
path forward for EVO100.
Fourth Quarter Financial Results
For the quarter
ended December 31, 2019, total
operating expenses decreased 14% to $12.9
million, compared to $15.0
million for the quarter ended December 31, 2018.
Research and development costs decreased $6.4 million, or 65%, to $3.4 million in the fourth quarter of 2019 versus
$9.8 million in the prior year
quarter. The decrease was primarily driven by lower clinical trial
expenses reflecting completion of the clinical phase of the Phase 3
AMPOWER study in November 2018 and of
the Phase 2b AMPREVENCE study in
August 2019, offset by higher payroll
related and consulting service fees.
General and administrative costs increased $4.2 million, or 81%, to $9.4 million in the fourth quarter of 2019 versus
$5.2 million in the prior year
quarter. This includes a $1.8 million
increase in pre-commercialization sales and marketing related
expenses, reflecting preparations for the potential approval and
launch of Phexxi for the prevention of pregnancy in the second
quarter of 2020; a $1.0 million
increase in payroll related expenses due to increased headcount; a
$1.0 million increase in consulting
services; and a $0.1 million increase
in noncash stock-based compensation in the fourth quarter of
2019.
As a result, net loss attributable to common stockholders
improved to $12.7 million, or
$(0.27) per share, for the fourth
quarter of 2019 compared with a net loss of $15.0 million, or $(0.58) per share, for the prior year
quarter.
Full Year Financial Results
For the year ended
December 31, 2019, total operating
expenses decreased 32% to $52.7
million, compared to total operating expenses of
$77.6 million for the year ended
December 31, 2018.
Research and development costs decreased 49% to $22.2 million, compared to $43.4 million in the prior year period. The
$21.2 million decrease in clinical
trial costs during the year ended December
31, 2019 was primarily related to completion of the clinical
phase of the AMPOWER and AMPREVENCE studies as previously
noted.
General and administrative costs decreased 11% to $30.5 million, compared to $34.2 million in the prior year period.
Noncash stock-based compensation decreased $7.2 million in the current period, since the
majority of stock-based awards granted in 2018 vested that year.
Professional services and personnel costs were $3.8 million lower due to the absence of one-time
costs associated with the Company's January
2018 merger. These were offset by a $3.4 million increase in pre-commercialization
advertising agency fees, public relations and sales support-related
costs during the current period. Additionally, payroll related
expenses and consulting services increased $2.3 million and $1.4
million, respectively, in the current period.
Total other expense was $27.3
million for the year ended December
31, 2019 and was primarily attributable to noncash charges
related to the closing of our private placement during the second
quarter of 2019, and to recognize various changes in the fair value
of warrants of $4.4 million in the
first quarter of 2019. Total other expense in the year ended
December 31, 2018 was $48.1 million, and included noncash losses on the
issuance of warrants and for the change in fair value of the Series
D 2X liquidation preference.
As a result, net loss attributable to common stockholders
improved to $80.0 million, or
$(1.99) per share, for the year ended
December 31, 2019, compared with a
net loss of $125.8 million, or
$(5.74) per share, for the year ended
December 31, 2018.
Liquidity and Subsequent Material Events
Unrestricted
cash and short-term investments were $23.8
million at December 31, 2019,
as compared to $35.8 million at
September 30, 2019.
Conference Call
As previously announced, the Evofem
management team will host a conference call to discuss its
financial results and business highlights as follows:
Date
|
March 12,
2020
|
Time
|
11:00 a.m. EDT (8:00
a.m. PDT)
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
5595046
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors" or click here
|
The live webcast and related slide presentation can be accessed
on the Company's Investor page
at https://evofem.investorroom.com/events. Please connect to
the Company's website at least 15 minutes prior to the start of the
call to download any software that may be required. If
participating by phone, please dial in approximately 10 minutes
prior to the start of the call.
A telephone replay will be available approximately two hours
after the call through Tuesday, March 17, 2020 at (855)
859-2056 (U.S.) or (404) 537-3406 (International), access code
5595046. The webcast will be archived at
https://evofem.investorroom.com/events.
About Phexxi™
Phexxi (L-lactic acid, citric
acid, potassium bitartrate) Vaginal Gel 1.8%/1%/0.4% is an
investigational Multipurpose Vaginal pH Regulator (MVP-R™) designed
to regulate vaginal pH within the normal range of 3.5 to 4.5, even
in the presence of semen, which normally raises the vaginal pH to
7.0 to 8.0. This maintains an acidic environment that is
inhospitable to sperm, as well as certain viral and bacterial
pathogens associated with sexually transmitted infections, but is
integral to the survival of healthy bacteria in the vagina.
About Evofem Biosciences, Inc.
Evofem Biosciences,
Inc., (NASDAQ: EVFM) is a clinical-stage biopharmaceutical company
committed to developing and commercializing innovative products to
address unmet needs in women's sexual and reproductive health.
Evofem Biosciences aims 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's lead product candidate, Phexxi™, is currently
being reviewed by the U.S. Food and Drug Administration for
prevention of pregnancy. The investigational candidate EVO100
is being evaluated for prevention of urogenital transmission of
both Chlamydia trachomatis infection (chlamydia)
and Neisseria gonorrhoeae infection (gonorrhea) in
women. For more information regarding Evofem, please
visit www.evofem.com.
Phexxi™ and Multipurpose Vaginal pH Regulator (MVP-R™) are
trademarks of Evofem Biosciences, Inc.
Forward-Looking Statements
This press release
contains "forward-looking statements" within the meaning of the
safe harbor provisions of the Private Securities Litigation Reform
Act of 1995, including statements related to the potential FDA
approval of Phexxi™, the anticipated commercial launch of Phexxi,
the timing and potential outcome of the scheduled meeting with the
FDA to discuss the AMPREVENCE trial results and the clinical path
for EVO100 for the prevention of urogenital acquisition
of Chlamydia trachomatis and Neisseria
gonorrhea in women. Each of these forward-looking
statements involves risks and uncertainties. Actual results may
differ materially from those, express or implied, in these
forward-looking statements. Important factors that could impair the
value of Evofem Biosciences' assets and business are disclosed in
the risk factors contained in its Annual Report on Form 10-K filed
with the Securities and Exchange Commission and
subsequent filings. All forward-looking statements are expressly
qualified in their entirety by such factors. Evofem Biosciences
does not undertake any duty to update any forward-looking statement
except as required by law.
Investor Contact
Amy
Raskopf
Evofem Biosciences
araskopf@evofem.com
M: (917) 673-5775
Media Contact
Cara
Miller
Evofem Biosciences, Inc.
cmiller@evofem.com
O: (858) 550-1900 x272
(Tables follow)
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED BALANCE SHEET DATA
(Unaudited)
(In
thousands)
|
|
|
|
|
|
December 31,
2019
|
|
December 31,
2018
|
Cash and cash
equivalents
|
$
|
15,571
|
|
|
$
|
1,330
|
|
Restricted
cash
|
304
|
|
|
431
|
|
Short-term
investments
|
8,233
|
|
|
—
|
|
Note
payable
|
—
|
|
|
4,010
|
|
Total current
liabilities
|
12,659
|
|
|
27,329
|
|
Total stockholders'
equity (deficit)
|
15,636
|
|
|
(23,356)
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
|
|
|
Quarter Ended
December 31,
|
|
Year Ended
December 31,
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Operating
expenses:
|
|
|
|
|
|
|
|
Research and
development
|
$
|
3,432
|
|
|
$
|
9,772
|
|
|
$
|
22,230
|
|
|
$
|
43,415
|
|
General and
administrative
|
9,440
|
|
|
5,209
|
|
|
30,512
|
|
|
34,227
|
|
Total operating
expenses
|
12,872
|
|
|
14,981
|
|
|
52,742
|
|
|
77,642
|
|
Loss from
operations
|
(12,872)
|
|
|
(14,981)
|
|
|
(52,742)
|
|
|
(77,642)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Interest
income
|
120
|
|
|
30
|
|
|
458
|
|
|
127
|
|
Other income
(expense), net
|
35
|
|
|
(30)
|
|
|
301
|
|
|
(145)
|
|
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)
|
|
Total other income
(expense), net
|
155
|
|
|
—
|
|
|
(27,287)
|
|
|
(48,068)
|
|
Loss before income
tax
|
(12,717)
|
|
|
(14,981)
|
|
|
(80,029)
|
|
|
(125,710)
|
|
Income tax
expense
|
—
|
|
|
—
|
|
|
(4)
|
|
|
(2)
|
|
Net loss
|
(12,717)
|
|
|
(14,981)
|
|
|
(80,033)
|
|
|
(125,712)
|
|
Accretion of Series D
redeemable convertible preferred stock dividends
|
—
|
|
|
—
|
|
|
—
|
|
|
(66)
|
|
Net loss attributable
to common stockholders
|
$
|
(12,717)
|
|
|
$
|
(14,981)
|
|
|
$
|
(80,033)
|
|
|
$
|
(125,778)
|
|
Net loss per share
attributable to common stockholders, basic and diluted
|
$
|
(0.27)
|
|
|
$
|
(0.58)
|
|
|
$
|
(1.99)
|
|
|
$
|
(5.74)
|
|
Weighted-average
shares used to compute net loss attributable to common
stockholders, basic and diluted
|
47,443,632
|
|
|
25,819,183
|
|
|
40,228,517
|
|
|
21,900,574
|
|
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SOURCE Evofem Biosciences, Inc.