Agile Therapeutics Announces New Agreement with vitaCare® Prescription Services to Improve Access to Twirla®
14 June 2023 - 6:05AM
Agile Therapeutics, Inc., (Nasdaq: AGRX), a women's healthcare
company, today announced an agreement with vitaCare Prescription
Services, a wholly owned subsidiary of GoodRx, to expand patient
access and streamline fulfillment for Twirla (levonorgestrel
ethinyl estradiol) transdermal system. VitaCare is a technology and
services platform that helps patients navigate key access barriers
for branded medications.
“The agreement with vitaCare aligns with our strategy to utilize
partnerships to efficiently grow Twirla while continuing to
responsibly manage our operating expenses,” said Agile
Therapeutics’ Chief Commercial Officer Amy Welsh.
“The goal for the vitaCare partnership is to strengthen Twirla’s
already meaningful momentum in our most profitable channel – the
retail channel. We believe the partnership with vitaCare will
create more opportunity to reach new Twirla patients for whom
access has been a barrier, while helping existing Twirla patients
stay on therapy. Our on-going plan is to expand our commercial
reach, which we expect will contribute to reaching our key 2023
financial goals of generating positive cash flow and delivering net
revenue in the range of $25-$30 million.”
Agile continues to grow Twirla’s presence on telemedicine
platforms, including Twentyeight Health, in addition to existing
partners like Pandia Health and Nurx as more women choose
telemedicine for their contraceptive needs. Twentyeight Health is a
telehealth company providing affordable access and convenience for
reproductive and sexual health and recently acquired the platform
assets for SimpleHealth. The Company believes that the Twentyeight
Health platform will provide an opportunity for more patients to
learn about and access Twirla.
About Agile
Therapeutics, Inc.Agile
Therapeutics is a women's healthcare company dedicated to
fulfilling the unmet health needs of today’s women. Our product and
product candidates are designed to provide women with contraceptive
options that offer freedom from taking a daily pill, without
committing to a longer-acting method. Our initial product, Twirla®,
(levonorgestrel and ethinyl estradiol), a transdermal system, is a
non-daily prescription contraceptive. Twirla is based on our
proprietary transdermal patch technology, called Skinfusion®, which
is designed to allow drug delivery through the skin. For more
information, please visit the company website at
www.agiletherapeutics.com. The Company may
occasionally disseminate material, nonpublic information on the
Company’s website, Twitter account (@agilether), and LinkedIn
account.
About Twirla®Twirla
(levonorgestrel and ethinyl estradiol) transdermal system is a
once-weekly combined hormonal contraceptive (CHC) patch that
contains the active ingredients levonorgestrel (LNG), a type of
progestin, and ethinyl estradiol (EE), a type of estrogen. Twirla
is indicated for use as a method of contraception by women of
reproductive potential with a body mass index (BMI) < 30 kg/m2
for whom a combined hormonal contraceptive is appropriate.
Healthcare providers (HCPs) are encouraged to consider Twirla’s
reduced efficacy in women with a BMI ≥ 25 to <30 kg/m2 before
prescribing. Twirla is contraindicated in women with a BMI ≥ 30
kg/m2. Twirla is also contraindicated in women over 35 years old
who smoke. Cigarette smoking increases the risk of serious
cardiovascular events from CHC use. Twirla is designed to be
applied once weekly for three weeks, followed by a week without a
patch.
Forward-Looking
StatementsCertain information contained in this
press release includes “forward-looking statements”, within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
We may, in some cases use terms such as “predicts,” “believes,”
“potential,” “continue,” “anticipates,” “estimates,” “expects,”
“plans,” “intends,” “may,” “could,” “might,” “likely,” “will,”
“should” or other words that convey uncertainty of the future
events or outcomes to identify these forward-looking statements.
Our forward-looking statements are based on current beliefs and
expectations of our management team that involve risks, potential
changes in circumstances, assumptions, and uncertainties, including
statements regarding expected Twirla demand metrics, net revenue
and operating expenses for the first quarter of 2023, our projected
net revenue and expected operating expenses for 2023, our ongoing
and planned manufacturing and commercialization of Twirla®, the
potential market acceptance and uptake of Twirla, including the
increasing demand for Twirla in 2023, our partnership with vitaCare
and its ability to promote growth, our product supply agreement
with Nurx, and other telemedicine providers and their ability to
drive additional retail channel growth in the second half of 2023,
our prospects for future financing arrangements, and our financial
condition, growth and strategies. Any or all of the forward-looking
statements may turn out to be wrong or be affected by inaccurate
assumptions we might make or by known or unknown risks and
uncertainties. These forward-looking statements are subject to
risks and uncertainties including risks related to the fact that
our estimated Twirla demand metrics, net revenue and operating
expenses for the first quarter of 2023 are not final and may be
subject to change, our ability to maintain regulatory approval of
Twirla and the labeling under any approval we obtain, the ability
of Corium to produce commercial supply in quantities and quality
sufficient to satisfy market demand for Twirla, our ability to
successfully enhance the commercialization of and increase the
uptake for Twirla, the size and growth of the markets for Twirla
and our ability to serve those markets, regulatory and legislative
developments in the United States and foreign countries, our
ability to obtain and maintain intellectual property protection for
Twirla and our product candidates, the lingering effects of the
COVID-19 pandemic on our commercialization efforts, clinical
trials, supply chain, operations and the operations of third
parties we rely on for services such as manufacturing, marketing
support and sales support, as well as on our potential customer
base, our ability to regain compliance with the listing
requirements of the Nasdaq Capital Market, our strategy, business
plans and focus, and the other risks set forth in our filings with
the U.S. Securities and Exchange Commission, including our Annual
Report on Form 10-K and our Quarterly Reports on Form 10-Q. For all
these reasons, actual results and developments could be materially
different from those expressed in or implied by our forward-looking
statements. You are cautioned not to place undue reliance on these
forward-looking statements, which are made only as of the date of
this press release. We undertake no obligation to publicly update
such forward-looking statements to reflect subsequent events or
circumstance.
Contact:Matt RileyHead of Investor Relations
& Corporate
Communicationsmriley@agiletherapeutics.com
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