SAN DIEGO, May 6, 2020 /PRNewswire/ -- Evofem Biosciences,
Inc. (NASDAQ: EVFM), a clinical-stage biopharmaceutical company,
today reported financial results for the three-month period ended
March 31, 2020.
"We are now less than three weeks away from the PDUFA date for
Phexxi™ and the potential to deliver the first non-hormonal
contraceptive innovation in decades. We are encouraged by our
ongoing discussions with the FDA regarding the potential label for
Phexxi and we look forward to sharing more details about our unique
Phexxi TeleContraception™ platform and other launch
initiatives on today's call," said Saundra
Pelletier, Evofem's Chief Executive Officer.
"Our recent strategic financing agreement for up to $25 million, coupled with our disciplined
approach to resource allocation, gives us the financial flexibility
we need to ensure that Phexxi gets the launch it deserves. If
approved, we plan to launch Phexxi in early September along with a
robust offering of support services designed to facilitate access
to Phexxi and establish Evofem as a leader in women's health."
Recent highlights:
- Entered into discussions with the U.S. Food and Drug
Administration (FDA) regarding the proposed label for Phexxi™
(L-lactic acid, citric acid, potassium bitartrate) , the Company's
investigational Multipurpose Vaginal pH Regulator (MVP-R™) for the
prevention of pregnancy. The Prescription Drug User Fee Act (PDUFA)
target action date for the completion of the FDA's review of the
New Drug Application (NDA) for Phexxi is May
25, 2020.
- After careful consideration of the impact of COVID-19 on all
aspects of the healthcare landscape, notably restrictions on
physician interactions, the Company made a strategic decision to
push the planned Phexxi commercial launch to the first week of
September.
- End-of-phase 2 meeting with the FDA scheduled for today to
discuss the AMPREVENCE study results, and determine the clinical
and regulatory path forward for EVO100, the Company's
investigational MVP-R candidate for the prevention of urogenital
chlamydia and gonorrhea in women.
- Secured up to $25 million in
strategic interim financing, with $15
million initially funded at close.
- Three new data sets from the Phase 3 AMPOWER trial of Phexxi
for prevention of pregnancy accepted for poster presentations at
the 2020 American College of Obstetricians and Gynecologists (ACOG)
annual meeting and published in Obstetrics & Gynecology (The
Green Journal) (May 2020, Vol
135).
First Quarter Financial Results
For the three months
ended March 31, 2020, total operating
expenses increased 41% to $19.2
million. The increase was almost entirely associated with
pre-commercialization efforts related to the potential U.S. launch
of Phexxi for hormone-free, woman-controlled, on-demand
contraception.
Research and development costs decreased $3.7 million, or 47%, to $4.2 million versus $7.9
million in the prior year quarter. The primary driver was a
$5.1 million decrease in clinical
trial expenses due to the timing of completing the clinical phases
of the AMPOWER and AMPREVENCE trials. This reduction was partially
offset by a $0.6 million increase in
costs incurred for outside services associated with the Phexxi NDA
resubmission and manufacturing in preparation for the anticipated
commercial launch of Phexxi, a $0.5
million increase in payroll related expenses due to
increased headcount, and a $0.2
million increase in noncash stock-based compensation.
Selling and marketing costs were $7.9
million in the first quarter of 2020, versus $1.1 million in the prior year quarter; sales and
marketing costs for the first quarter of 2019 were reclassified
from general and administrative expenses to conform to the current
period presentation. The $6.8 million
increase includes a $3.7 million
increase in pre-commercialization marketing related expenses,
reflecting preparations for the potential launch of Phexxi for the
prevention of pregnancy; a $1.6
million increase in marketing and medical affairs consulting
services; an $0.8 million increase in
payroll-related expenses due to increased headcount; and a
$0.3 million increase in noncash
stock-based compensation.
General and administrative costs were $7.1 million in the first quarter of 2020, versus
$4.6 million in the prior year
quarter. The $2.5 million increase
includes a $0.9 million increase in
noncash stock-based compensation in the first quarter of 2020; a
$0.6 million increase in payroll
related expenses due to increased headcount; and a $0.6 million increase in consulting service fees
predominantly related to sales force recruiting.
As a result, net loss was $19.1
million, or $(0.40) per share,
for the first quarter of 2020 compared with a net loss of
$18.1 million, or $(0.67) per share, for the prior year
quarter.
Liquidity and Subsequent Material Events
Unrestricted
cash and short-term investments were $10.3
million at March 31, 2020, as
compared to $23.8 million at
December 31, 2019.
In April 2020, the Company raised
$15 million from the sale of
convertible notes and warrants with a U.S.-based,
healthcare-focused institutional investor under a private
Securities Purchase Agreement. An additional $10
million may be funded at the Investor's discretion at any time
prior to the Company meeting specific funding requirements defined
in the Agreement.
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
|
May 6,
2020
|
Time
|
11:00 a.m. ET (8:00
a.m. PT)
|
Dial-in
numbers
|
(866) 503-5561 (U.S.
toll-free) or (253) 336-2965
|
Passcode
|
6295478
|
Webcast (live and
archived)
|
www.evofem.com under
"Investors"
|
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 Monday, May 11, 2020 at (855)
859-2056 (U.S.) or (404) 537-3406 (International), access code
6295478. The webcast will be archived at
https://evofem.investorroom.com/events.
About Phexxi™
Phexxi (L-lactic acid, citric acid,
potassium bitartrate 1.8%/1%/0.4%) Vaginal Gel 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.
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™, Multipurpose Vaginal pH Regulator (MVP-R™) and
TeleContraception™ 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, and
Quarterly Report on 10-Q for the first quarter of 2020 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)
|
|
|
March 31,
2020
|
|
December 31,
2019
|
Cash and cash
equivalents
|
$
|
8,785
|
|
|
$
|
15,571
|
|
Restricted
cash
|
480
|
|
|
304
|
|
Short-term
investments
|
1,486
|
|
|
8,233
|
|
Total current
liabilities
|
14,461
|
|
|
12,659
|
|
Total stockholders'
equity
|
1,021
|
|
|
15,636
|
|
EVOFEM
BIOSCIENCES, INC. AND SUBSIDIARIES
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except
share and per share data)
|
|
|
Three Months Ended
March 31,
|
|
2020
|
|
2019
|
Operating
expenses:
|
|
|
|
Research and
development
|
$
|
4,247
|
|
|
$
|
7,889
|
|
Selling and
marketing
|
7,855
|
|
|
1,118
|
|
General and
administrative
|
7,142
|
|
|
4,625
|
|
Total operating
expenses
|
19,244
|
|
|
13,632
|
|
Loss from
operations
|
(19,244)
|
|
|
(13,632)
|
|
Other income
(expense):
|
|
|
|
Interest
income
|
102
|
|
|
18
|
|
Other
expense
|
(4)
|
|
|
(14)
|
|
Change in fair value
of warrants
|
—
|
|
|
(4,440)
|
|
Total other income
(expense), net
|
98
|
|
|
(4,436)
|
|
Loss before income
tax
|
(19,146)
|
|
|
(18,068)
|
|
Income tax
expense
|
—
|
|
|
—
|
|
Net loss
|
(19,146)
|
|
|
(18,068)
|
|
Net loss per share,
basic and diluted
|
$
|
(0.40)
|
|
|
$
|
(0.67)
|
|
Weighted-average
shares used to compute net loss, basic and diluted
|
$
|
48,195,951
|
|
|
$
|
26,883,734
|
|
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SOURCE Evofem Biosciences, Inc.