SAN DIEGO, July 1, 2020 /PRNewswire/ -- Evofem
Biosciences, Inc. (NASDAQ: EVFM), a commercial-stage
biopharmaceutical company, today announced that it has issued a
letter to its stockholders providing an update on recent events and
outlook for the remainder of 2020 and early 2021.
The full text of the letter follows below.
A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER
To My Fellow Stockholders:
As we begin the second half of what has been an unprecedented
and unpredictable year, I want to begin with a message
of gratitude, admiration and support:
- For the healthcare workers who are putting themselves at risk
to treat and care for patients with COVID-19;
- For the essential business owners and employees who have been
instrumental in ensuring people have access to food, water and
other basic needs; and
- For the individuals who remain steadfast in their fight against
racism and inequality in all its forms.
We appreciate and celebrate your commitment to challenging the
status quo, putting others first and addressing disparities in our
healthcare system and beyond.
I am proud to say that Evofem Biosciences has long been a
champion for equal rights – working to break down barriers to
equality and advance new products that put women in control of
their own sexual and reproductive health. We are a female-forward
company supported by a predominantly female Executive Team and
Board of Directors (50% and 60%, respectively) and our values
reflect a focus on diversity, inclusion and opportunity.
Together, this team has advanced from clinical trials through
U.S. Food and Drug Administration (FDA) approval, the first
contraceptive innovation in decades – Phexxi™ (lactic acid,
citric acid and potassium bitartrate). Phexxi speaks to a
significant unmet need in Women's Health – offering women a safe
and effective female-controlled, non-hormonal, on-demand
contraceptive gel for use only when she needs it and
never when she doesn't.
We are also focused on the lack of innovation in the prevention
of women's acquisition of urogenital chlamydia and gonorrhea. These
two dangerous sexually transmitted diseases impact more than 2.1
million people in the U.S., yet there are still no FDA-approved
preventative prescription products.
As we are now at the halfway mark of one of the most
transformational years in the history of Evofem Biosciences, it
seemed timely and appropriate for me to provide an update on the
significant regulatory and financial milestones we have already
achieved, as well as our expectations for the remainder of
2020.
Key Accomplishments in the First Half of 2020
- Received U.S. FDA approval of Phexxi for the prevention of
pregnancy in females of reproductive potential for use as an
on-demand method of contraception;
- Participated in a productive end-of-Phase 2 meeting with the
FDA to discuss the clinical and regulatory path forward for EVO100
for the prevention of urogenital chlamydia and gonorrhea, laying
the foundation for us to advance this important program into a
Phase 3 clinical trial later this year;
- Strengthened our Board of Directors with the addition of former
FDA Division Deputy Director Lisa
Rarick, M.D., F.A.C.O.G.;
- Published three new data abstracts from the Phase 3 AMPOWER
trial of Phexxi for prevention of pregnancy in Obstetrics &
Gynecology (The Green Journal). These data were also accepted
for presentation at the 2020 American College of Obstetricians and
Gynecologists (ACOG) annual meeting; and,
- Raised approximately $136
million in gross proceeds from the close of two transactions
during an incredibly challenging time in the financial
markets:
-
- An underwritten public offering of common stock that both
launched and closed in early June; and
- A private placement of convertible notes and warrants with a
U.S.-based, healthcare-focused institutional investor.
We believe the tremendous show of support we received in the
first half of 2020 from such a diverse group of institutional
investors with impressive biotech and pharmaceutical portfolios
speaks to their confidence in Evofem's management team and in our
commercialization strategy for Phexxi.
Planned Milestones in the Second Half of 2020
Heading into the second half of 2020, we have a strengthened
balance sheet with cash runway expected to fund planned operations
into Q2 2021, clear direction from the FDA on our plans for EVO100
and a concentrated focus on several key deliverables,
including:
- Launch preparations for Phexxi, which have been underway
for months, and the "Coming Soon" campaign, which will launch this
summer. This campaign is designed to raise awareness among women
and health care providers of the pending commercial availability of
an innovative hormone-free, on-demand contraceptive.
- The full commercial launch and product availability of Phexxi,
which is on track for early September and includes the Phexxi
Concierge Experience, a comprehensive telemedicine support system
designed to make access to Phexxi for women who are "beyond
hormones," seamless and rapid. The Phexxi Concierge Experience will
also provide physicians with on-demand educational support, and
speed and simplify women's access to Phexxi.
- A robust publication and presentation plan that includes:
-
- Publication of the full Phase 3 AMPOWER study results in a
well-respected, peer-reviewed journal;
- Presentation/publication of additional data from AMPREVENCE,
the Phase 2b trial of EVO100 for
prevention of chlamydia and gonorrhea in women.
- Initiation of the pivotal Phase 3 clinical trial for EVO100 for
the prevention of urogenital chlamydia and gonorrhea, slated to
begin in the fourth quarter of 2020 - positioning us to report
top-line results in 2022.
Despite the challenges of the current external environment,
Evofem is operating from a position of financial and executional
strength. Our experienced management team is focused on driving the
successful launch of Evofem's innovative, FDA-approved prescription
contraceptive asset; continuing to address unmet needs in women's
sexual and reproductive health; and executing on our long-term
strategy to create value for women and stockholders alike.
In Closing
We are highly confident in our ability to deliver the first new
contraceptive innovation in decades to the millions of women who
have been waiting for an option that speaks to them because
we understand their needs and are leveraging the three critical
pillars for success:
- Unmet need. In the United States today, there are more
than 17 million women who don't want to get pregnant, don't want
hormones in their birth control, and who are fed up with their
current options. What they do want is protection, control, an
option that doesn't require hormones and one that speaks to their
needs.
- Innovation. Phexxi is the first and only non-hormonal,
prescription contraceptive product that women can use at their
discretion to protect themselves when they need it.
- An experienced team that knows how to execute. Our
organization is made up of people who have ensured the success of
some of the largest and most successful assets in this category,
and we are confident that we have developed an innovative and
comprehensive launch strategy for Phexxi.
As you might imagine, we are very excited about the future
potential of Evofem Biosciences and we are thrilled to have you
with us on this journey. We appreciate your ongoing support.
Warmest regards,
Saundra Pelletier
President, Chief Executive Officer and Shareholder
Evofem Biosciences
***
About Phexxi™ (lactic acid, citric acid and potassium
bitartrate) Vaginal Gel
Phexxi is indicated for the
prevention of pregnancy in females of reproductive potential for
use as an on-demand method of contraception.
Limitations of Use
Phexxi is not effective for the
prevention of pregnancy when administered after intercourse.
Warnings and Precautions
Few cases (0.36%) reported
adverse reactions of cystitis, pyelonephritis and other upper
urinary tract infection (UTI) have been reported in Phexxi clinical
studies. Of these, one case of pyelonephritis was considered
serious and required hospitalization. Avoid use of Phexxi in
females of reproductive potential with history of recurrent urinary
tract infection or urinary tract abnormalities.
Adverse Reactions
Most common adverse reactions (≥2%)
were vulvovaginal burning sensation, vulvovaginal pruritus,
vulvovaginal mycotic infection, urinary tract infection,
vulvovaginal discomfort, bacterial vaginosis, vaginal discharge,
genital discomfort, dysuria, and vulvovaginal pain.
Patients should be counseled on the following:
- To contact and consult with their healthcare provider for
severe or prolonged genital irritation or experiencing urinary
tract symptoms.
- To discontinue Phexxi if they develop a local
hypersensitivity reaction.
- That Phexxi does not protect against HIV infection (AIDS) or
other sexually transmitted infections.
Please see full Prescribing Information for Phexxi. To report
suspected adverse reactions, contact Evofem at toll-free phone
1-833-EVFMBIO or you may contact FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
About Evofem Biosciences, Inc.
Evofem Biosciences,
Inc., (NASDAQ: EVFM) is a commercial-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 quality of life for
women by developing innovative solutions, such as hormone-free,
woman-controlled contraception and protection from certain sexually
transmitted infections (STIs). The Company's first commercial
product, Phexxi™ (lactic acid, citric acid and potassium
bitartrate), is approved in the United
States for the prevention of pregnancy. The Company is
advancing EVO100 for the prevention of urogenital transmission of
both Chlamydia trachomatis infection (chlamydia)
and Neisseria gonorrhoeae infection (gonorrhea) in
women.
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 related to Evofem's expectations regarding
its burn rate and cash runway, the success and timing of the
commercial launch of Phexxi, the success of the Phexxi Concierge
Experience, the execution and success of our publication and
presentation plan, and the timing of our Phase 3 clinical trial for
EVO100. 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 Evofem's SEC filings, including its Annual Report
on Form 10-K for the year ended December 31,
2019 filed with the SEC on March 12,
2020, its Quarterly Report on Form 10-Q for the quarter
ended March 31, 2020 filed with the
SEC on May 6, 2020 and its Current
Report on Form 8-K filed with the SEC on June 2, 2020. All forward-looking statements are
expressly qualified in their entirety by such factors. Evofem does
not undertake any duty to update any forward-looking statement
except as required by law.
Contact
Investor Relations
Amy Raskopf
Evofem Biosciences
araskopf@evofem.com
O: (858) 550-1900 x167
M: (917) 673-5775
Media
Cara Miller
Evofem Biosciences
cmiller@evofem.com
O: (858) 550-1900 x272
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SOURCE Evofem Biosciences, Inc.