-- Double digit growth in net revenues over
Q4 2021 --
-- Reduced selling and marketing costs 49%
and total operating expense 19% vs. Q4 2021 --
-- Decreased loss from operations for the
third consecutive quarter --
-- On track to report top-line Phase 3 data
for the prevention of chlamydia and gonorrhea in 2H 2022
--
-- Conference call scheduled for
4:30 p.m. ET Today --
SAN
DIEGO, May 4, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (Nasdaq: EVFM) ("Evofem" or the
"Company"), today reported financial results for the three-month
period ended March 31, 2022.
"The impact of our disciplined fiscal approach has yielded
another quarter of solid performance for Evofem," said Saundra Pelletier, Chief Executive Officer of
Evofem. "Our business remains strong and in growth mode, with our
third consecutive quarter of increased revenue, a 30 percentage
point improvement in gross-to-net, and a reduction in operating
expenses of nearly 20%. We are on an upward trajectory and expect
these trends to continue. We look forward to the readout of the
registrational Phase 3 EVOGUARD clinical trial investigating
Phexxi for the prevention of chlamydia and gonorrhea."
First Quarter and Recent Highlights:
- Increased Phexxi® (lactic acid, citric acid and
potassium bitartrate) net product sales 19% to $4.3 million for the first quarter of 2022 vs.
fourth quarter 2021;
- Improved gross-to-net adjustments to 38%, up 30 percentage
points from the prior quarter;
- Reduced selling and marketing costs by 49%, driving a 19%
decrease in total operating expense;
- Improved loss from operations for the third consecutive quarter
to $28.9 million;
- Contraceptive guidelines updated by the U.S. Department of
Labor and Health Resources and Services Administration in an effort
to ensure women have access to all FDA-approved contraceptives,
including Phexxi, at zero copay under the Affordable Care Act;
- The Journal of Sexual Medicine published data from the
Phase 3 AMPOWER trial demonstrating 88.7% of women using Phexxi
improved or maintained their sexual satisfaction;
- On track to report top-line results in the second half of 2022
from EVOGUARD, the registrational Phase 3 trial evaluating
Phexxi for the prevention of chlamydia and gonorrhea in women;
- Strengthened team with the appointment of Karina Fedasz as Head of Business Development to
focus initially on opening new markets for Phexxi outside the
U.S.
Financial Results
For the three months ended
March 31, 2022, Phexxi net product
sales increased to $4.3 million, an
increase of 19% versus $3.6 million
for the three months ended December 31,
2021. The increase reflects an improvement of 30 percentage
points in gross-to-net adjustments to 38% for the first quarter of
2022, reflecting the positive impact of adjustments to Evofem's
patient support programs in January
2022.
Total operating expenses decreased 19% to $33.2 million for the first quarter of 2021
compared to $41.0 million in the
fourth quarter of 2021.
- Research and development costs were $10.4 million, compared to $8.7 million in the fourth quarter of 2021,
reflecting higher clinical trial expenses for the registrational
Phase 3 EVOGUARD trial of Phexxi for two potential new
indications - prevention of urogenital chlamydia and urogenital
gonorrhea infections in women.
- Selling and marketing costs were $12.7
million, a 49% decrease compared to $24.9 million in the fourth quarter of 2021,
primarily due to lower direct-to-consumer marketing costs.
- General and administrative costs were $9.0 million, compared to $5.7 million in the fourth quarter of 2021,
primarily due to higher outside services fees.
As a result, loss from operations improved to $28.9 million for the three months ended
March 31, 2022, compared to a loss
from operations of $37.4 million for
the three months ended December 31,
2021.
Liquidity
In the first quarter of 2022, Evofem raised
$10 million in gross proceeds from
registered direct offerings of notes and received net proceeds of
approximately $5.4 million from its
equity line of credit. An additional $0.3
million was recorded as other receivables since it was
received after the quarter closed.
At March 31, 2022, the Company had $2.8 million in unrestricted cash and
$4.2 million in restricted cash,
as compared to $7.7 million of
unrestricted cash and $5.1 million of
restricted cash at December 31,
2021.
Conference Call
As previously announced, the Evofem
management team will host a conference call to discuss its first
quarter 2022 financial results and business outlook on Wednesday, May 4, 2022 at 4:30 p.m. ET (1:30 p.m.
PT) as follows:
Date:
|
Wednesday, May 4,
2022
|
Time:
|
4:30 p.m. ET (1:30 p.m.
PT)
|
Live call:
|
(877) 407-0890 (U.S.
toll-free) or (201) 389-0918
|
Webcast (live and
archived)
and related slide presentation:
|
https://evofem.investorroom.com/2022Q1Results or
https://www.webcast-eqs.com/evofem20220504/en
|
Please connect to the webcast 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 15 minutes
prior to the start of the call.
About Evofem Biosciences, Inc.
Evofem Biosciences,
Inc., (NASDAQ: EVFM) is developing and commercializing innovative
products to address unmet needs in women's sexual and reproductive
health, including hormone-free, woman-controlled contraception and
protection from certain sexually transmitted infections (chlamydia
and gonorrhea). The Company's first FDA-approved product,
Phexxi® (lactic acid, citric acid and potassium
bitartrate), is a hormone-free, on-demand prescription
contraceptive vaginal gel. It comes in a box of 12 pre-filled
applicators and is applied 0-60 minutes before each act of sex.
Learn more at phexxi.com and evofem.com.
Phexxi® is a registered trademark of Evofem
Biosciences.
Forward-Looking Statements
This press release includes
"forward-looking statements," within the meaning of the safe harbor
for forward-looking statements provided by Section 21E of the
Securities Exchange Act of 1934, as amended, and the Private
Securities Litigation Reform Act of 1995 including, without
limitation, statements, evaluations and judgments related to
potential growth, the ongoing development of Phexxi for new
indications, including related timelines, top-line data releases
and FDA submissions, and future growth of sales of Phexxi and the
Company generally. Various factors could cause actual results
to differ materially from those discussed or implied in the
forward-looking statements, and you are cautioned not to place
undue reliance on these forward-looking statements, which are
current only as of the date of this press release. Each of these
forward-looking statements involves risks and uncertainties.
Important factors that could cause actual results to differ
materially from those discussed or implied in the forward-looking
statements, or that could impair the value of Evofem Biosciences'
assets and business, are disclosed in the Company's SEC filings,
including its Annual Report on Form 10-K for the year ended
December 31, 2021 filed with the SEC
on March 10, 2022. All
forward-looking statements are expressly qualified in their
entirety by such factors. The Company does not undertake any duty
to update any forward-looking statement except as required by
law.
Investor Relations
Contact
|
Media
Contact
|
Amy Raskopf
|
Jack
Hirschfield
|
Evofem Biosciences,
Inc.
|
Evofem Biosciences,
Inc.
|
araskopf@evofem.com
|
jhirschfield@evofem.com
|
(917)
673-5775
|
(512)
674-5163
|
View original content to download
multimedia:https://www.prnewswire.com/news-releases/evofem-biosciences-reports-first-quarter-2022-financial-results-and-provides-corporate-update-301540013.html
SOURCE Evofem Biosciences, Inc.