2022-10-07 | NDAQ:AGRX | Press release
Amy Welsh’s appointment as Chief Commercial Officer prioritizes business growth
Company streamlines management team to align with Twirla growth plan®
James Tursi, MD resigns from Board of Directors
PRINCETON, NJ, Oct. 07, 2022 (GLOBE NEWSWIRE) — Agile Therapeutics, Inc. (Nasdaq: AGRX), a women’s healthcare company, today announced that it has revamped and streamlined its team of management to align with its business plan to promote Twirla® (levonorgestrel and ethinylestradiol) growth of the transdermal system. As part of the changes, the company announced the appointment of Amy Welsh as Chief Commercial Officer effective November 1, 2022. Additionally, James P. Tursi, MD has informed the company that he will be resigning from the Board of Directors. of the company from October. 7, 2022.
“Our focus in 2022 has been to grow Twirla and progress towards generating positive cash flow,” said Agile Therapeutics CEO Al Altomari. “In 2022, we significantly reduced our operating expenses by rethinking the way we work to gain efficiency and implementing a plan that we believe can drive Twirla’s growth through our Afaxys partnership, our campaign connected television (CTV) and the growth of the telemedicine channel. The changes to our leadership team that we are announcing today should help us consolidate the efficiencies we have achieved in our operations by streamlining my leadership team and maintaining our focus on executing our business plan. ‘business.”
In addition to her current responsibilities leading Twirla’s marketing team, Ms. Welsh, as Chief Commercial Officer, will assume responsibility for all commercial functions of the company. Ms. Welsh joined the company in May 2020 as Vice President, Marketing. Prior to joining Agile, Ms. Welsh was Vice President of Marketing at Antares Pharma, Inc. and held various positions of increasing responsibility at AstraZeneca.
The Company has also appointed Geoffrey P. Gilmore to the newly created position of Chief Administrative Officer. In this role, Mr. Gilmore will be responsible for all corporate and administrative functions of the company (“G&A” CloseCurlyDoubleQuote;), including corporate secretary, legal, human resources, finance, investor relations and quality assurance. This will allow the Company to consolidate and streamline its G&A functions into one group. Mr. Gilmore previously served as general counsel for the company.
The company’s leadership team will also include Robert G. Conway, the company’s director of corporate planning and supply chain, who will be responsible for the company’s manufacturing and supply chain functions as well as corporate planning, and Paul Korner, MD, MBA, the company’s medical director, who will be responsible for the company’s medical and research functions and will be part of the company’s business development team.
On October 4, 2022, Dr. Tursi informed the Board of Directors that he intended to resign from the Board of Directors to devote more of his time to his role as Executive Vice President, Global Research and Development of Endo Pharmaceuticals. Mr. Tursi joined the board in 2016 and currently chairs the board’s science and technology committee and sits on the compensation committee. The Company does not intend to occupy Dr. Tursi’s seat. The Board of Directors is assessing how it intends to fulfill the mandates of Dr. Tursi’s committee.
“James Tursi has provided important strategic insight, guidance and support throughout his long tenure on the Agile Board of Directors,” said Mr. Altomari. Agile’ board and leadership team, I would like to thank James for his service to the company.”
Agile Therapeutics is a women’s healthcare company dedicated to addressing the unmet health needs of women today. Our products and product candidates are designed to provide women with birth control options that allow them to skip the daily pill, without committing to a long-acting method. Our initial product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on our exclusive transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. For more information, please visit the company’s website at www.agiletherapeutics.com. The Company may occasionally post material, non-public information to the Company’s website, Twitter account (@agilether) and LinkedIn Account.
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 progestogen, and ethinyl estradiol (EE), a type of estrogen. Twirla is indicated as a method of contraception in women of childbearing potential with a body mass index (BMI) 2 for whom a combined hormonal contraceptive is appropriate. Healthcare providers (HCPs) are encouraged to consider the reduced effectiveness of Twirla’ in women with a BMI ≥25 to 2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. Twirla is also contraindicated in women over 35 who smoke.
Smoking increases the risk of serious cardiovascular events related to CHC use. Twirla is designed to be applied once a week for three weeks, followed by a patch-free week.
Certain information 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,” “continues,” “anticipates,” “estimates,” “expects,” “plans,” “intends,” “ may,” “could,” “might,” “likely,” “will,” “should” or other words that convey uncertainty about future events or results to identify these forward-looking statements. Our forward-looking statements are based on the current beliefs and expectations of our management team which involve risks, potential changes in circumstances, assumptions and uncertainties, including statements regarding our ongoing and planned manufacturing and marketing of Twirla.®, potential market acceptance and adoption of Twirla, including growing demand for Twirla, our partnership with Afaxys and its ability to drive growth, our product supply agreement with Nurx and its ability to educate patients about Twirla, our connected television (CTV) campaign and its ability to promote growth, our future plans regarding our existing debt financing with Perceptive Advisors, our ability to generate positive cash flow, our prospects for financing agreements future, as well as our operating expenses, financial condition, growth and strategies. Any or all of the forward-looking statements may prove to be inaccurate or be affected by inaccurate assumptions that we may make or by known or unknown risks and uncertainties. These forward-looking statements are subject to risks and uncertainties, including risks relating to our ability to maintain regulatory approval of Twirla and labeling under any approval we obtain, Corium’s ability to produce a commercial supply of sufficient quantities and quality to satisfy market demand for Twirla, our ability to successfully improve commercialization and increase adoption of Twirla, the size and growth of Twirla’s markets and our ability to serve those markets, regulatory developments and legislative requirements in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla and our product candidates, the effects of the ongoing COVID-19 pandemic on our commercialization efforts, clinical trials, supply chain, operations and the operations of third parties we rely on for r services such as manufacturing, marketing and sales support, as well as our potential customer base, our ability to control maintain compliance with Nasdaq Capital Market listing requirements and the other risks set forth in our filings with the United States Securities and Exchange Commission, including our Annual Report on Form 10-K and our Quarterly Reports on Form 10-Q. For these reasons, actual results and developments could differ materially from those expressed or implied by our forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update these forward-looking statements to reflect subsequent events or circumstances.
Head of Investor Relations & Corporate Communication