-- 42% growth in Phexxi® (lactic
acid, citric acid and potassium bitartrate) net
product sales quarter over quarter --
-- Reduced operating expense by 8% and
improved loss from operations by 16% --
-- Completed registrational Phase 3 trial
evaluating Phexxi for the prevention of chlamydia and gonorrhea; on
track to report top-line data in October
2022 --
-- Conference call scheduled for
5:00 p.m. ET today --
SAN
DIEGO, Aug. 4, 2022 /PRNewswire/ -- Evofem
Biosciences, Inc., (Nasdaq: EVFM) ("Evofem" or the
"Company"), today reported financial results for the three- and
six-month periods ended June 30, 2022
and affirmed full-year 2022 guidance.
"We are pleased to report another consecutive quarter of
improved operating results - strong revenue growth, lower operating
expense, and improved operating loss," said Saundra Pelletier, Chief Executive Officer of
Evofem. "We expect ongoing growth will be driven by our sales and
marketing initiatives, as well as market access expansion as payers
and PBMs continue to add Phexxi to their formularies with no
restrictions to comply with federal guidance."
"We look forward to the top-line data readout in October of our
registrational Phase 3 trial evaluating Phexxi for the prevention
of chlamydia and gonorrhea," Pelletier added. "With no prescription
pharmaceuticals approved to prevent these sexually transmitted
infections, we believe these potential new indications represent
significant upside for shareholders, above and beyond the
$7.9 billion U.S. contraceptive
market which we continue to increasingly penetrate with Phexxi for
hormone-free contraception."
Second Quarter and Recent Highlights:
- Increased Phexxi® (lactic acid, citric acid and
potassium bitartrate) net product sales 42% to $6.0 million for the second quarter of 2022 vs.
first quarter 2022.
- Increased Phexxi access and approved claim rate through wins
with health insurance plans and pharmacy benefit managers (PBMs)
including a long-term contract with one of the largest PBMs in the
nation, which added Phexxi to its formulary with no
restrictions.
- The U.S. government clarified that it will enforce federal law
requiring group health plans and health insurance issuers to cover
contraception at no cost to participants.
- The Nasdaq Stock Market LLC's Hearings Panel amended its
decision to grant the Company's request for continued listing of
shares of its common stock on the Nasdaq Capital Market without
completing a reverse stock split provided the Company is able to
evidence a closing bid price of at least $1.00 per share on August
8, 2022 and each day thereafter through August 22, 2022.
- Closed the second quarter with $19.9
million in unrestricted cash and $1.6
million in restricted cash.
Second Quarter Financial Results
For the three
months ended June 30, 2022, Phexxi
net product sales increased to $6.0
million, an increase of 42% versus $4.3 million for the three months ended
March 31, 2022. The increase reflects
higher ex-factory sales and lower gross-to-net adjustments of 40%
for the second quarter of 2022.
Total operating expenses decreased 8% to $30.5 million for the second quarter of 2022,
compared to $33.2 million in the
first quarter of 2022.
- Research and development costs were $7.7
million, compared to $10.4
million in the first quarter of 2022, reflecting lower
clinical trial expenses as women exited the registrational Phase 3
trial of Phexxi for the prevention of chlamydia and gonorrhea in
women. The last subject last visit occurred in late July 2022.
- Selling and marketing costs decreased to $12.3 million, compared to $12.7 million in the first quarter of 2022.
- General and administrative costs increased to $9.1 million, compared to $9.0 million in the first quarter of 2022.
As a result, loss from operations improved 16% to $24.4 million for the three months ended
June 30, 2022, compared to a loss
from operations of $28.9 million for
the three months ended March 31,
2022.
Liquidity
At June 30, 2022, the Company had
$19.9 million in unrestricted cash
and $1.6 million in restricted
cash, as compared to $7.7 million of
unrestricted cash and $5.1 million of
restricted cash at December 31,
2021.
In the second quarter of 2022, Evofem raised net proceeds of
approximately $18.1 million from
the sale and issuance of common stock, common warrants, and
pre-funded warrants from an underwritten public offering in
May 2022 and approximately
$2.0 million from the Company's
equity line of credit. During the second quarter and through
August 3, 2022, Evofem received
$22.4 million from the exercise of
common warrants that were issued in the May
2022 underwritten public offering. Shares outstanding were
82,449,214 as of August 3, 2022.
Guidance
Evofem continues to expect net product
sales in the range of $30 to
$35 million for its 2022 fiscal year,
representing 264% to 325% growth year-over-year. Gross-to-net is
expected to be 40% or better, trending toward the lower in the
second half of the year. The Company remains on track to meet its
goal of reducing costs by $50 million
in 2022; total operating expenses were $25.3
million lower in the first half of 2022 versus the same
period last year.
Conference Call
As previously announced, the
Company will host a conference call to discuss its second quarter
2022 financial results and business outlook as follows:
Date:
|
Thursday, August 4,
2022
|
Time:
|
5:00 p.m. ET (2:00 p.m.
PT)
|
Live call:
|
(800) 285-6670 (U.S.
toll-free) or (713) 481-1320
|
Webcast (live and
archived) and related slide presentation:
|
https://evofem.investorroom.com/2022Q2Results
or
https://www.webcast-eqs.com/evofem20220804/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 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. The Company expects to report
top-line data in October 2022 from
its registrational Phase 3 EVOGUARD
clinical trial evaluating Phexxi for two
potential new indications – prevention of chlamydia
and prevention of gonorrhea in women. 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, any financial
guidance, and the Company's ability to maintain the listing of
shares of its common stock on the Nasdaq Capital
Market. 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 and its Quarterly
Report on Form 10-Q filed with the SEC on May 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. This press release contains estimates
and other statistical data made by independent parties and by the
Company relating to market size and growth and other data about its
industry. This data involves a number of assumptions and
limitations, and you are cautioned not to give undue weight to such
estimates.
Investor Relations
Contact
|
Media
Contact
|
Amy Raskopf
|
media@evofem.com
|
Evofem Biosciences,
Inc.
|
|
araskopf@evofem.com
|
|
(917)
673-5775
|
|
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SOURCE Evofem Biosciences, Inc.