AGRX Agile Therapeutics Inc.

1.03
0  0%
Previous Close 1.03
Open 1.03
52 Week Low 0.9302
52 Week High 3.84
Market Cap $95,789,963
Shares 92,999,964
Float 75,697,884
Enterprise Value $78,919,963
Volume 287,153
Av. Daily Volume 679,608
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Drug Pipeline

Drug Stage Notes
TWIRLA
Contraceptive patch
Approved
Approved
FDA Approval announced February 14, 2020.

Latest News

  1. PRINCETON, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today announced that management will present and participate at the following virtual investor conferences during the month of September 2021.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (September 20-23, 2021)

    Cantor Fitzgerald Virtual Global Healthcare Conference

    PRINCETON, N.J., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today announced that management will present and participate at the following virtual investor conferences during the month of September 2021.

    H.C. Wainwright 23rd Annual Global Investment Conference (September 13-15, 2021)

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (September 20-23, 2021)

    Cantor Fitzgerald Virtual Global Healthcare Conference 2021 (September 27-30, 2021)

    Live webcasts of all presentations and any accompanying presentation materials, as well as the archived recordings, will be available on the Company's Investor Relations website, https://ir.agiletherapeutics.com/. Following each conference, archived recordings will be available on the Company's website for at least 30 days.

    For more information or to schedule a meeting with Agile management, please contact your conference representative or Matt Riley via email at mriley@agiletherapeutics.com.

    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.

    Contact: 

    Matt Riley

    Head of Investor Relations & Corporate Communications

    mriley@agiletherapeutics.com



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    • Pandia Health is a doctor founded and led telehealth company, offering online prescriptions and free delivery designed to make it easier for women to access birth control options that meet their needs
    • Partnership represents first telehealth alliance for Agile's Twirla® birth control patch

    PRINCETON, N.J., Aug. 20, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today announced a partnership with Pandia Health, an online telehealth service, which will establish the first telehealth relationship for Agile and offer an additional point of access to Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in a fast-growing channel.

    Pandia Health offers convenient prescription fulfillment for…

    • Pandia Health is a doctor founded and led telehealth company, offering online prescriptions and free delivery designed to make it easier for women to access birth control options that meet their needs

    • Partnership represents first telehealth alliance for Agile's Twirla® birth control patch

    PRINCETON, N.J., Aug. 20, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today announced a partnership with Pandia Health, an online telehealth service, which will establish the first telehealth relationship for Agile and offer an additional point of access to Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in a fast-growing channel.

    Pandia Health offers convenient prescription fulfillment for women with active birth control prescriptions, as well as access to expert birth control doctors who can provide prescriptions through asynchronous online visits. All patients receive free delivery of their birth control. The Company and Pandia plan to phase in the availability of Twirla in the second half of 2021.

    "The telehealth channel is growing in importance, and our goal was to find a partner that shares our values and focus on women's health. We are thrilled to partner with Pandia Health, a truly innovative leader in this space, and we think this relationship allows Agile to offer another point of access to Twirla® as more women choose telehealth for their contraceptive needs," said Amy Welsh, Vice President of Marketing at Agile Therapeutics. "The team at Pandia shares our commitment to listening -- and responding -- to what women need with regard to their birth control options."

    "Pandia Health's mission is to make women's lives easier by bringing birth control to women wherever they have internet and a mailbox," said Dr. Sophia Yen, founder of Pandia Health. "As the only doctor-led, women-founded, women-led birth control delivery company, we are excited to partner with a women's healthcare company like Agile Therapeutics to pursue affordable access to another method of birth control."

    The use of telehealth in contraceptive care has grown over the past several years and has come into the spotlight during the COVID-19 pandemic. A recent article in the reproductive health journal Contraception examined trends in how women accessed contraceptive care during the COVID-19 pandemic, finding a decrease for in-person visits and a subsequent increase in the use of telehealth. A 2020 report by the Guttmacher Institute found that 24 percent of women using the pill reported that, because of the pandemic, they had switched to a telemedicine appointment with their health care provider to have their prescription refilled.

    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) 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.

    About Pandia Health

    Pandia Health is the only doctor-led, women-founded, women-led telehealth company. Pandia Health offers patients asynchronous online visits with expert birth control doctors and free delivery. Sophia Yen, M.D., M.P.H., co-founded Pandia Health in 2016 and is passionate about making women's lives easier, preventing unplanned pregnancies, and educating women about reproductive health. Pandia Health makes women's lives easier by providing a one-stop shop for recurring medications, starting with birth control. From affordable telehealth to prescription fulfillment and medicine delivery, Pandia Health is reinventing the way patients get their prescription medication.

    Forward-Looking Statement

    Certain 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 our ongoing and planned manufacturing and commercialization of Twirla®, the potential market acceptance and uptake of Twirla, including the increasing demand for Twirla, our results of operations, growth and strategies, the expected benefits of our marketing and sales distribution 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 our ability to maintain regulatory approval of Twirla, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully commercialize Twirla, the accuracy of our estimates of the potential market and the market demand for Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely upon as well as on our potential customer base 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 circumstances.

    Contact: 

    Matt Riley

    Head of Investor Relations & Corporate Communications

    mriley@agiletherapeutics.com



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  2. Total Prescriptions (TRx) Grew 171% in Second Quarter

    Prescribers, New Prescriptions and Refill Rates Continue to Grow in Second Quarter

    Company Continues to Progress on Expanding Access to Twirla

    Management to Host Conference Call Today, Monday, July 26, 2021 at 4:30 p.m. EDT

    PRINCETON, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today reported financial results for the three months ended June 30, 2021 and provided a corporate update.

    "The theme of Agile's 2021 second quarter is growth. We believe we have the building blocks in place for continued growth and we remain on track to achieve our near-term goal of establishing Twirla in the $4.1B…

    Total Prescriptions (TRx) Grew 171% in Second Quarter

    Prescribers, New Prescriptions and Refill Rates Continue to Grow in Second Quarter

    Company Continues to Progress on Expanding Access to Twirla

    Management to Host Conference Call Today, Monday, July 26, 2021 at 4:30 p.m. EDT

    PRINCETON, N.J., July 26, 2021 (GLOBE NEWSWIRE) -- Agile Therapeutics, Inc. (NASDAQ:AGRX), a women's healthcare company, today reported financial results for the three months ended June 30, 2021 and provided a corporate update.

    "The theme of Agile's 2021 second quarter is growth. We believe we have the building blocks in place for continued growth and we remain on track to achieve our near-term goal of establishing Twirla in the $4.1B U.S. hormonal contraceptive market," said Chairman and Chief Executive Officer Al Altomari. "We have an approved product that is growing in all major prescription performance areas and we believe we are only scratching the surface as we unleash more direct-to-consumer advertising and further develop the channels that provide women access to Twirla."

    Recent Corporate Developments and Second Quarter 2021 Results:

    Twirla Performance and Updates

    • During the second quarter 2021, total prescriptions were 5,027, representing an increase of 171% from the end of the first quarter. New prescriptions were 2,857 and grew by 103% over the same period. The growth was driven by an increase in the number of prescribers, which as of June 30, 2021 was more than 2,087 healthcare providers (HCPs), and growing refill rates. As of June 30, 2021, 2,033 prescriptions dispensed at pharmacies were refills, which represented an increase of 355% during the second quarter. The Company also saw an increase in the number of total prescriptions by prescriber.



    • Twirla is now available to Medicaid patients in approximately 75% of states either through traditional Medicaid and/or managed Medicaid. With these new additions, Twirla now has coverage in approximately 50% of the total Medicaid transdermal TRx market with no restrictions. Overall, Twirla has access in approximately 55% of the commercial and government CHC market based on claims.



    • In addition to progress on Medicaid and Managed Care access, the Company also saw expanded access through state clinics, where there was significant non-retail prescription volume in the second quarter.

    Marketing Campaign Updates

    • The Company increased its incremental branded consumer marketing investment quarter over quarter in the second quarter, and Twirla's advertising presence on dating apps such as Tinder and OK Cupid exceeded expectations in less than a month.



    • The Company believes that as more women in the target audience gain exposure to Twirla through branded advertising efforts, Twirla prescriptions will continue to grow.

    Second Quarter 2021 Financial Results

    • Net revenue: The Company delivered $1.2 million in net product sales revenue in the second quarter.



    • Cost of product revenues: The cost of product revenues for the quarter ended June 30, 2021 was $1.1 million which included direct and indirect expenses supporting our manufacturing and distribution efforts, including personnel costs and approximately $500,000 of non-cash depreciation expense. The Company expects these relatively fixed costs to become less significant as a percentage of sales with anticipated volume increases. Until May of 2021, the Company was selling units from validation batches that had no associated product cost as the cost had been previously expensed. Approximately 76% of the units sold in the second quarter had associated product cost. All future sales of product will have an associated product cost.



    • Total operating expenses:  Total operating expenses were $16.7 million for the quarter ended June 30, 2021, compared to $10.0 million for the comparable period in 2020.  The increase in year-over-year expenses mostly reflected higher selling and marketing expenses, including our contract sales force expenses and brand-building expenses.



    • Research and development (R&D) expenses: R&D expenses were approximately $0.9 million for the quarter ended June 30, 2021, compared to $3.7 million for the comparable period in 2020. The decrease in period-over-period R&D expenses was primarily attributable to the absence of 2020 pre-validation manufacturing costs for commercial manufacturing of Twirla by Corium, the Company's contract manufacturer.



    • Selling and marketing expenses: Selling and marketing expenses were $11.7 million for the quarter ended June 30, 2021, compared to $3.2 million for the comparable period in 2020. The increase in period-over-period selling and marketing expenses was due to higher costs associated with activities for Twirla, including brand building and advocacy, and development of the Company's contract sales force.



    • General and administrative (G&A) expenses: G&A expenses were $4.1 million for the quarter ended June 30, 2021, compared to $3.2 million for the comparable period in 2020.  The increase in year-over-year G&A expenses reflected higher personnel costs and higher professional fees.



    • Net loss: Net loss was $17.6 million, or $0.20 per share, for the quarter ended June 30, 2021, compared to a net loss of $10.8 million, or $0.12 per share, for the comparable period in 2020.



    • Cash, cash equivalents and marketable securities: As of June 30, 2021, Agile had $31.1 million of cash, cash equivalents and marketable securities, compared to $54.5 million as of December 31, 2020.



    • Shares Outstanding: As of June 30, 2021, Agile had 92,928,205 shares of common stock outstanding.

    Financial Update

    • Agile has $25 million of capital potentially available through its loan facility with Perceptive Advisors, including a tranche of $15 million in 2021, and a tranche of $10 million, which will be available through June 2022, both contingent on achieving a pre-determined revenue target.



    • Additionally, the Company has the potential to access additional capital through its existing at-the-market arrangement, under which Agile may sell up to an aggregate of $50 million in gross proceeds through the sale of shares of common stock.

    Conference Call and Webcast

    DateMonday, July 26, 2021
    Time4:30 p.m. EDT
    Webcast (live and archived)Events & Presentations
    Dial-in numbers(833) 979-2857 (U.S. toll-free) or (236) 714-2948
    Conference ID1732729

    Investors interested in listening to the conference call may do so by dialing (833) 979-2857 for domestic callers or (236) 714-2948 for international callers. A live webcast will be available in the Events and Presentations section of the Investor Relations page at https://ir.agiletherapeutics.com/events-and-presentations/, or by clicking here

    Please log in approximately 10 minutes prior to the scheduled start time. The archived webcast will be available in the Events and Presentations section of the company's website.

    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 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.

    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) 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.

    Forward-Looking Statement

    Certain 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 our ongoing and planned manufacturing and commercialization of Twirla®, the potential market acceptance and uptake of Twirla, including the increasing demand for Twirla, our results of operations, revenues, financial condition, liquidity, prospects, growth and strategies, the expected benefits of our marketing and sales distribution strategies, including the use of samples to grow prescriptions, current and future Medicare coverage for Twirla, the development of our other potential product candidates, the length of time that we will be able to continue to fund our operating expenses and capital expenditures and our expected financing needs and sources of financing, including our debt financing from Perceptive Advisors. 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 our ability to maintain regulatory approval of Twirla, the ability of Corium to produce commercial supply in quantities and quality sufficient to satisfy market demand for Twirla, our ability to successfully commercialize Twirla, the accuracy of our estimates of the potential market and the market demand for Twirla, regulatory and legislative developments in the United States and foreign countries, our ability to obtain and maintain intellectual property protection for Twirla, our strategy, business plans and focus, the effects of the COVID-19 pandemic on our operations and the operations of third parties we rely upon as well as on our potential customer base, our ability to meet or exceed the revenue thresholds necessary to permit us to access the remaining amounts available under our existing debt financing from Perceptive Advisors 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 circumstances.

    Contact: 

    Matt Riley

    Head of Investor Relations & Corporate Communications

    mriley@agiletherapeutics.com



    Agile Therapeutics, Inc.

    Balance Sheets

    (Unaudited)

    (in thousands, except par value and share data)

          
     June 30,  December 31, 
     2021    2020
    Assets     
    Current assets:     
    Cash and cash equivalents$26,118  $14,463 
    Marketable securities 4,999   40,008 
    Accounts receivable, net 1,167   865 
    Inventory 3,462    
    Prepaid expenses and other current assets 1,202   1,449 
    Total current assets 36,948   56,785 
    Property and equipment, net 13,363   14,243 
    Right of use asset 72   138 
    Other non-current assets 1,896   1,896 
    Total assets $52,279  $73,062 
          
    Liabilities and stockholders' equity     
    Current liabilities:     
    Accounts payable$6,410  $3,867 
    Accrued expenses 5,153   3,348 
    Lease liability, current portion 72   138 
    Total current liabilities 11,635   7,353 
          
    Long-term debt 16,035   16,381 
    Total liabilities  27,670   23,734 
    Commitments and contingencies (Note 12)     
    Stockholders' equity     
    Common stock, $.0001 par value, 150,000,000 shares authorized, 92,928,205 and 87,563,753 issued and outstanding at June 30, 2021 and December 31, 2020, respectively 9   9 
    Additional paid-in capital 371,588   361,539 
    Accumulated other comprehensive income    3 
    Accumulated deficit (346,988)  (312,223)
    Total stockholders' equity  24,609   49,328 
    Total liabilities and stockholders' equity $52,279  $73,062 



    Agile Therapeutics, Inc.

    Statements of Operations

    (Unaudited)

    (in thousands, except per share and share data)

                
     Three Months Ended  Six Months Ended
     June 30,  June 30, 
     2021    2020    2021    2020
                
    Revenues, net$1,185  $  $1,301  $ 
    Cost of product revenues 1,145      2,306    
    Gross profit (loss) 40      (1,005)   
                
    Operating expenses:           
    Research and development$862  $3,661  $2,975  $6,825 
    Selling and marketing 11,714   3,150   20,877   4,892 
    General and administrative 4,115   3,228   8,016   5,939 
    Total operating expenses 16,691   10,039   31,868   17,656 
    Loss from operations (16,651)  (10,039)  (32,873)  (17,656)
                
    Other income (expense)           
    Interest income 7   115   23   247 
    Interest expense (993)  (902)  (1,915)  (1,300)
    Total other income (expense), net (986)  (787)  (1,892)  (1,053)
    Loss before benefit from income taxes (17,637)  (10,826)  (34,765)  (18,709)
    Benefit from income taxes           
    Net loss$(17,637) $(10,826) $(34,765) $(18,709)
                
    Net loss per share (basic and diluted)$(0.20) $(0.12) $(0.39) $(0.23)
                
    Weighted-average common shares (basic and diluted) 88,693,968   87,221,441   88,162,929   81,936,815 
                



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  3. AGRX)" src="https://www.getnews.info/wp-content/uploads/2021/07/1626704534.png" alt="Proprietary Transdermal Advancements for Easier, Non-Daily Contraception Options in Women: Agile Therapeutics (NASDAQ:AGRX)" width="225" height="77" /&gt;
    • Women’s Healthcare Company with Proprietary Transdermal Products.

    • Focus on Innovative Alternatives to Oral Contraception for Modern Women.

    • Prescription Growth Reflects Increasing Demand for Twirla Product.  

    • Growing Distribution Network and Marketing Efforts Expected to Drive Healthcare Provider and Consumer Engagement.

    • Presentation Given at 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. 

    Agile Therapeutics (NASDAQ: AGRX) is a forward-looking

    AGRX)" src="https://www.getnews.info/wp-content/uploads/2021/07/1626704534.png" alt="Proprietary Transdermal Advancements for Easier, Non-Daily Contraception Options in Women: Agile Therapeutics (NASDAQ:AGRX)" width="225" height="77" />
    • Women’s Healthcare Company with Proprietary Transdermal Products.

    • Focus on Innovative Alternatives to Oral Contraception for Modern Women.

    • Prescription Growth Reflects Increasing Demand for Twirla Product.  

    • Growing Distribution Network and Marketing Efforts Expected to Drive Healthcare Provider and Consumer Engagement.

    • Presentation Given at 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. 

    Agile Therapeutics (NASDAQ: AGRX) is a forward-looking women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. AGRX 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. The initial AGRX product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on AGRX proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. 

    • First Quarter 2021 Update

    On May 4thAGRX gave a corporate update for the three months ended March 31, 2021. 

    Twirla Performance and Updates

    During the first quarter 2021, total prescriptions were 1,853. The growth was driven by an increase in the number of prescribers, which as of March 31, 2021 was more than 850 HCPs, and growing refill rates. As of March 31, 2021, 447 of prescriptions dispensed at pharmacies were refills. AGRX also saw an increase in the number of total prescriptions by prescriber.      

    • AGRX believes its momentum in prescriptions reflects underlying demand for Twirla and is supported by steady growth in the first quarter, which has continued into the early second quarter.  

    • AGRX continues to focus on expanding access and reimbursement coverage for Twirla across managed care and government health insurance plans. During the first quarter 2021, AGRX made progress in obtaining Medicaid coverage for Twirla. Currently, Twirla is covered with no prior authorization in 20 states with expected coverage pending in Texas in May 2021. The Medicaid market represents a large number of combined hormonal contraceptive (“CHC”) users; Medicaid volumes for oral CHC total prescriptions in 2020 were nearly eight million.   

    • In February 2021, AGRX entered into a specialty distribution agreement with Sterling Specialty Pharmacy (“Sterling”). AGRX believes that the relationship with Sterling will facilitate increased access to Twirla based on early results, which have been productive in increasing uptake of Twirla. AGRX continues to explore the potential to expand its distribution network through other channels that can support growth of Twirla demand including telemedicine.

    Marketing Campaign Updates

    • AGRX continues to support I’m So Done, an education and empowerment unbranded awareness campaign that encourages women to think about their current contraceptive method and decision-making journey. AGRX has seen increased activity on its website and various applications, including Tik Tok.  

    • Beginning in the second quarter AGRX plans to shift a significant portion of its investment in marketing to its branded campaign. AGRX plans to focus its branded campaign efforts on driving awareness and trial of Twirla, with a goal of meeting women throughout their everyday routine with a targeted digital strategy.  Ongoing efforts include a multi-channel creative campaign that positions Twirla as the first and only weekly contraceptive patch that delivers a low dose of estrogen. AGRX plans to expand its digital reach to other applications including Tinder and OkCupid, as well as Spotify. These three applications reach millions of U.S. women between the ages of 18 and 34 on a monthly basis.

    Financial Update

    • AGRX has $25 million of capital potentially available through its loan facility with Perceptive Advisors, including a tranche of $15 million in 2021, and a tranche of $10 million, which will be available through June 2022, both contingent on achieving a pre-determined revenue target. 

    • Additionally, AGRX has the potential to access additional capital through its existing at-the-market arrangement, under which AGRX may sell up to an aggregate of $50 million in gross proceeds through the sale of shares of common stock.

    • ARGX Presentation of Safety and Efficacy Data on TWIRLA® (LEVONORGESTREL and ETHINYL ESTRADIOL) Transdermal System in Women of Differing BMI Categories 

    On April 30th AGRX announced that a post hoc analysis of the Phase 3 SECURE Trial evaluating the safety and efficacy of its Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in women with BMI < 25 kg/m2 and women with BMI 25-30 kg/m2 would be presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting from April 30 – May 2.

    The AGRX Twirla product was approved based on the Phase 3 SECURE Trial, a United States, multicenter, single-arm, open-label, 13-cycle trial that evaluated the efficacy, safety and tolerability of Twirla in 2,032 healthy women. Twirla is a combination of levonorgestrel and ethinyl estradiol indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. 

    The AGRX U.S. package insert also includes a Limitation of Use statement guiding prescribers to consider Twirla’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. This post hoc analysis of SECURE assessed the efficacy, safety and tolerability of Twirla in women with BMI < 25 kg/m2 and BMI 25-30 kg/m2. When compared to women with BMI < 25 kg/m2, Twirla demonstrated lower but acceptable efficacy while maintaining similar safety and tolerability in women with BMI 25-30 kg/m2.

    The results of this post hoc analysis help AGRX to inform providers counseling women that fall within BMI 25-30 kg/m2 who may be considering a non-oral, noninvasive contraception option. These data support the safety and tolerability of Twirla in women within BMI 25-30 kg/m2 as well as those with BMI < 25 kg/m2.”

    The AGRX Twirla product (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.

    For more information on Agile Therapeutics (AGRX) visit www.agiletherapeutics.com  

    DISCLAIMER:

    CAP/FrontPageStocks/CorporateAds.com (CA) is a third-party publisher and news dissemination service provider. CAP/FPS/CA is NOT affiliated in any manner with any company mentioned herein. CAP/FPS/CA is a news dissemination solutions provider and is NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. CAP/FPS/CA’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release or opinion of the writer. CAP/FPS/ CA is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. CAP/FPS/CA has been compensated $500 by a third party for dissemination of this article.

    Disclaimer/Safe Harbor:

    These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

    Media Contact
    Company Name: Agile Therapeutics, Inc.
    Contact Person: Alfred F Altomari, MBA, CHAIRMAN & CHIEF EXECUTIVE OFFICER
    Email: Send Email
    Phone: 609 683 1880
    Address:101 Poor Farm Road
    City: Princeton
    State: NJ 08540
    Country: United States
    Website: https://agiletherapeutics.com/

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  4. AGRX)" src="https://www.getnews.info/wp-content/uploads/2021/07/1625505370.jpeg" alt="Women’s Healthcare Company dedicated to fulfilling the unmet health needs of today’s Modern Women: Agile Therapeutics (NASDAQ:AGRX)" width="225" height="190" /&gt;
    • Women’s Healthcare Company with Proprietary Transdermal Products.

    • Focus on Innovative Alternatives to Oral Contraception for Modern Women.

    • Prescription Growth Reflects Increasing Demand for Twirla Product.  

    • Growing Distribution Network and Marketing Efforts Expected to Drive Healthcare Provider and Consumer Engagement.

    • Presentation Given at 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. 


    Agile Therapeutics (NASDAQ:
    AGRX) is a forward-looking

    AGRX)" src="https://www.getnews.info/wp-content/uploads/2021/07/1625505370.jpeg" alt="Women’s Healthcare Company dedicated to fulfilling the unmet health needs of today’s Modern Women: Agile Therapeutics (NASDAQ:AGRX)" width="225" height="190" />
    • Women’s Healthcare Company with Proprietary Transdermal Products.

    • Focus on Innovative Alternatives to Oral Contraception for Modern Women.

    • Prescription Growth Reflects Increasing Demand for Twirla Product.  

    • Growing Distribution Network and Marketing Efforts Expected to Drive Healthcare Provider and Consumer Engagement.

    • Presentation Given at 2021 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting. 


    Agile Therapeutics (NASDAQ:
    AGRX) is a forward-looking women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. AGRX 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. The initial AGRX product, Twirla®, (levonorgestrel and ethinyl estradiol), a transdermal system, is a non-daily prescription contraceptive. Twirla is based on AGRX proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin. 

    • First Quarter 2021 Update

    On May 4thAGRX gave a corporate update for the three months ended March 31, 2021. 

    Twirla Performance and Updates

    During the first quarter 2021, total prescriptions were 1,853. The growth was driven by an increase in the number of prescribers, which as of March 31, 2021 was more than 850 HCPs, and growing refill rates. As of March 31, 2021, 447 of prescriptions dispensed at pharmacies were refills. AGRX also saw an increase in the number of total prescriptions by prescriber.      

    • AGRX believes its momentum in prescriptions reflects underlying demand for Twirla and is supported by steady growth in the first quarter, which has continued into the early second quarter.  

    • AGRX continues to focus on expanding access and reimbursement coverage for Twirla across managed care and government health insurance plans. During the first quarter 2021, AGRX made progress in obtaining Medicaid coverage for Twirla. Currently, Twirla is covered with no prior authorization in 20 states with expected coverage pending in Texas in May 2021. The Medicaid market represents a large number of combined hormonal contraceptive (“CHC”) users; Medicaid volumes for oral CHC total prescriptions in 2020 were nearly eight million.   

    • In February 2021, AGRX entered into a specialty distribution agreement with Sterling Specialty Pharmacy (“Sterling”). AGRX believes that the relationship with Sterling will facilitate increased access to Twirla based on early results, which have been productive in increasing uptake of Twirla. AGRX continues to explore the potential to expand its distribution network through other channels that can support growth of Twirla demand including telemedicine.


    Marketing Campaign Updates

    • AGRX continues to support I’m So Done, an education and empowerment unbranded awareness campaign that encourages women to think about their current contraceptive method and decision-making journey. AGRX has seen increased activity on its website and various applications, including Tik Tok.  

    • Beginning in the second quarter AGRX plans to shift a significant portion of its investment in marketing to its branded campaign. AGRX plans to focus its branded campaign efforts on driving awareness and trial of Twirla, with a goal of meeting women throughout their everyday routine with a targeted digital strategy.  Ongoing efforts include a multi-channel creative campaign that positions Twirla as the first and only weekly contraceptive patch that delivers a low dose of estrogen. AGRX plans to expand its digital reach to other applications including Tinder and OkCupid, as well as Spotify. These three applications reach millions of U.S. women between the ages of 18 and 34 on a monthly basis.


    Financial Update

    • AGRX has $25 million of capital potentially available through its loan facility with Perceptive Advisors, including a tranche of $15 million in 2021, and a tranche of $10 million, which will be available through June 2022, both contingent on achieving a pre-determined revenue target. 

    • Additionally, AGRX has the potential to access additional capital through its existing at-the-market arrangement, under which AGRX may sell up to an aggregate of $50 million in gross proceeds through the sale of shares of common stock.

    • ARGX Presentation of Safety and Efficacy Data on TWIRLA® (LEVONORGESTREL and ETHINYL ESTRADIOL) Transdermal System in Women of Differing BMI Categories 


    On April 30
    thAGRX announced that a post hoc analysis of the Phase 3 SECURE Trial evaluating the safety and efficacy of its Twirla® (levonorgestrel and ethinyl estradiol) transdermal system in women with BMI < 25 kg/m2 and women with BMI 25-30 kg/m2 would be presented at the American College of Obstetricians and Gynecologists (ACOG) Annual Clinical and Scientific Meeting from April 30 – May 2.

    The AGRX Twirla product was approved based on the Phase 3 SECURE Trial, a United States, multicenter, single-arm, open-label, 13-cycle trial that evaluated the efficacy, safety and tolerability of Twirla in 2,032 healthy women. Twirla is a combination of levonorgestrel and ethinyl estradiol indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate. 

    The AGRX U.S. package insert also includes a Limitation of Use statement guiding prescribers to consider Twirla’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m2 before prescribing. Twirla is contraindicated in women with a BMI ≥ 30 kg/m2. This post hoc analysis of SECURE assessed the efficacy, safety and tolerability of Twirla in women with BMI < 25 kg/m2 and BMI 25-30 kg/m2. When compared to women with BMI < 25 kg/m2, Twirla demonstrated lower but acceptable efficacy while maintaining similar safety and tolerability in women with BMI 25-30 kg/m2.

    The results of this post hoc analysis help AGRX to inform providers counseling women that fall within BMI 25-30 kg/m2 who may be considering a non-oral, noninvasive contraception option. These data support the safety and tolerability of Twirla in women within BMI 25-30 kg/m2 as well as those with BMI < 25 kg/m2.”

    The AGRX Twirla product (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.

    For more information on Agile Therapeutics (AGRX) visit www.agiletherapeutics.com  

    DISCLAIMER:

    CAP/FrontPageStocks/CorporateAds.com (CA) is a third-party publisher and news dissemination service provider. CAP/FPS/CA is NOT affiliated in any manner with any company mentioned herein. CAP/FPS/CA is a news dissemination solutions provider and is NOT a registered broker/dealer/analyst/adviser, holds no investment licenses and may NOT sell, offer to sell or offer to buy any security. CAP/FPS/CA’s market updates, news alerts and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release or opinion of the writer. CAP/FPS/ CA is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. CAP/FPS/CA has been compensated $500 by a third party for dissemination of this article.

    Disclaimer/Safe Harbor:

    These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

    Media Contact
    Company Name: Agile Therapeutics, Inc.
    Contact Person: Alfred F Altomari, MBA, CHAIRMAN & CHIEF EXECUTIVE OFFICER
    Email: Send Email
    Phone: 609 683 1880
    Address:101 Poor Farm Road
    City: Princeton
    State: NJ 08540
    Country: United States
    Website: https://agiletherapeutics.com/

    View Full Article Hide Full Article
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