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Agile Therapeutics, Inc. (Nasdaq: AGRX) is a forward-thinking company specializing in women's healthcare. Their mission is to address the unmet health needs of today’s women by providing innovative contraceptive options. The company’s leading product, Twirla® (ethinyl estradiol and levonorgestrel transdermal system), is a once-weekly prescription contraceptive patch that offers an alternative to daily pills or longer-acting methods. Twirla employs Agile's proprietary Skinfusion® technology designed to improve patch adhesion and patient comfort.
Recently, Agile Therapeutics has reported significant financial and operational accomplishments. In the third quarter of 2023, Twirla achieved net revenue of $6.7 million, reflecting a 21% increase from the second quarter and a 122% increase year-over-year. The company projects positive cash flow from operations by the first quarter of 2024, backed by a strong gross margin that grew to 63% in the third quarter of 2023.
The company’s strategic focus includes expanding their market presence through partnerships and promotional efforts, notably targeting five key states with high reimbursement potential. Agile is also enhancing Twirla's availability through telemedicine platforms like Nurx, TwentyEight Health, and Pandia, aiming to broaden its reach further.
Operational expenses have been managed effectively, with a reported decrease in GAAP operating expenses to $8.2 million in the third quarter of 2023. This financial discipline, alongside the anticipated revenue, positions Agile Therapeutics favorably for sustainable growth.
Additionally, Agile Therapeutics has successfully completed the pay-off of their debt facility with Perceptive Advisors, leaving their balance sheet debt-free. Despite a delisting notice from Nasdaq, the company’s shares continue to trade on the OTC Market, maintaining its focus on executing its business plan and exploring strategic opportunities to maximize Twirla’s growth and shareholder value.
For more detailed updates, latest news, and information, you can visit their website at www.agiletherapeutics.com or follow them on Twitter @agilether.
Agile Therapeutics (Nasdaq: AGRX) reported a first-quarter 2022 net revenue of $1.8 million, aligning with its guidance. The company experienced double-digit growth in Twirla demand, with significant increases in total prescriptions, new prescriptions, and prescribers. Operating expenses were $15.8 million, slightly higher than the prior year, but within guidance. Agile plans to lower future expenses and has improved its cash position with recent financing. Notably, the company regained compliance with Nasdaq's bid price requirement after its stock was under scrutiny.
Agile Therapeutics (Nasdaq: AGRX) announced the results of its first-year pharmacovigilance safety surveillance for Twirla®, a transdermal contraceptive system. The FDA-approved product showed consistency with the SECURE trial results, demonstrating no venous thromboembolic events and only two serious adverse events reported during the post-marketing period. Approximately 11,000 women-years of data were collected, and adhesion issues were rare, with only 14 replacements needed. The data highlights Twirla's safety profile in real-world use and supports its continuing acceptance among healthcare providers.
Agile Therapeutics (Nasdaq: AGRX) will release its Q1 2022 financial results on May 12, 2022, after market close. A live conference call and webcast will follow at 4:30 p.m. ET to discuss these results and provide a business update. Investors can dial in using (888) 330-2454 (U.S.) or (240) 789-2714 (international) with conference ID 7871426. The event will also be available for replay via the company's Investor Relations page.
Agile Therapeutics, Inc. (Nasdaq: AGRX) announced a 1-for-40 reverse stock split effective April 26, 2022. This move aims to increase the stock price to comply with Nasdaq's minimum bid requirement. Post-split, approximately 146.7 million shares will reduce to about 3.7 million shares, with adjustments made to stock options and warrants. Stockholders will not need to take action for electronic shares, while those with physical certificates will receive instructions for exchange. The CUSIP number will change as of April 26, 2022.
Agile Therapeutics (Nasdaq: AGRX) reported strong growth in Twirla prescription data for Q1 2022, with a 29% increase in cycles dispensed (16,602) and a 27% rise in total prescriptions (12,494). New prescriptions grew by 22% to 5,351, and refill prescriptions saw a 31% increase to 7,143. The total number of prescribers also rose 26% to 5,837. The company is focusing on initiatives such as the Afaxys partnership and a commercial campaign to sustain this growth momentum throughout 2022.
Agile Therapeutics (Nasdaq: AGRX) announced receiving $4.7 million in net proceeds from the New Jersey Economic Development Authority's Net Operating Loss (NOL) program. This non-dilutive funding will support the company's operations and growth plans for 2022. The NOL program allows NJ-based biotechnology firms to sell net operating losses to profitable corporations, providing a cash influx for growth activities, including R&D.
Agile Therapeutics (Nasdaq: AGRX) announced that data from its first-year postmarketing pharmacovigilance safety surveillance for Twirla (levonorgestrel and ethinyl estradiol) will be presented at the 2022 ACOG Annual Meeting from May 4-6, 2022. The company emphasized its commitment to patient safety and expressed encouragement regarding the first-year safety data. The poster presentation will be available to attendees and online after May 6, 2022. Twirla is a once-weekly contraceptive patch aimed at women with a BMI < 30 kg/m², with specific contraindications outlined.
Agile Therapeutics (AGRX) launched its first consumer commercial for the Twirla birth control patch on March 30, 2022. The ad targets women aged 18-24, aiming to reach 5.7 million viewers in five key states. Unlike traditional advertising, the campaign utilizes CTV for tailored audience engagement. Directed by Maya Albanese, the ad highlights the importance of female relationships and reproductive health choices. The company emphasizes its commitment to transparency and authenticity, aligning with Gen Z's values, while the Twirla patch is designed for women with a BMI < 30.
Agile Therapeutics (Nasdaq: AGRX) reported Q4 2021 results showing significant growth in Twirla demand, with total prescriptions increasing by 33% and total cycles dispensed by 32% compared to Q3 2021. The company is set to launch a new connected TV commercial in April 2022 to further boost demand. Total net revenue for Q4 was $1.5 million, and full-year revenue reached $4.1 million. However, Agile faced a net loss of $23.4 million for Q4 and $74.9 million for the full year, highlighting ongoing financial challenges. The company is focusing on partnerships and targeted markets to enhance growth.
Agile Therapeutics (Nasdaq: AGRX) has completed a registered direct offering, raising approximately $4.85 million through the sale of 2,425 shares of Series A and Series B convertible preferred stock along with warrants to purchase up to 24,250,000 shares of common stock. Each preferred share has a stated value of $1,000 and a conversion price of $0.20 per share. Proceeds will be utilized for working capital and corporate purposes. H.C. Wainwright & Co. served as the exclusive placement agent for the transaction.
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