Agile Therapeutics Gets a Path Forward for Twirla, Analysts Review and Target

Agile Therapeutics, Inc. (Nasdaq: AGRX) is a forward-thinking women’s healthcare company dedicated to fulfilling the unmet health needs of today’s women. The company’ 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 company’ shares continue to zoom backed by the favorable impact of its recent announcements, and after it announced the completion of Formal Dispute Resolution Process with the FDA. Furthermore, from liquidity and financial standpoint, the Company believes its cash and cash equivalents as of June 30, 2018, will be sufficient to meet its operating requirements into the second quarter of 2019.


Oct. 09, 2018, the company announced that it had received a response from FDA’s Office of New Drugs (“OND”) concerning the Company’s formal dispute resolution request.  The Company had appealed the decision by the FDA’s Division of Bone, Reproductive and Urological Products (“DBRUP”) that concerns surrounding the in vivo adhesion properties of Twirla prevent its approval. While OND has formally denied the Company’s appeal, OND provided a path forward without the need to reformulate Twirla or conduct a bioequivalence study between formulations, as previously suggested by DBRUP.


“We appreciate the constructive discussions we’ve had with the FDA during this formal dispute resolution process.  We are pleased that OND has provided a path forward, and we plan to meet with the Division to discuss the specifics of the proposed wear study as soon as possible.  We look forward to resubmitting the NDA for Twirla after completion of our wear trial and welcome the opportunity to discuss the potential safety and efficacy of Twirla at an Advisory Committee Meeting,” said Al Altomari, Chairman and Chief Executive Officer of Agile Therapeutics, Inc.  Mr. Altomari continued, “After we agree on the parameters of the wear study, we anticipate providing a further business update, which will review our cash guidance and planned resubmission timeline.”


Fine prints of OND decision:

  • OND suggested that the Company conduct a wear study to evaluate whether Twirla demonstrates a generally similar adhesion performance to Xulane®, the generic version of the previously marketed Ortho Evra®contraceptive patch, a product the FDA considers to have acceptable adhesion.
  • If this result is demonstrated, OND stated that the study would support the conclusion of adequate Twirla adhesion.
  • OND has recommended that the Company first meet with DBRUP to gain agreement on the specific design and success criteria of a wear study for Twirla.
  • Generally, wear studies are conducted by generic companies during the Phase 1 development of transdermal products and are significantly smaller in scope and shorter in duration than typical Phase 3 contraceptive clinical trials.
  • The wear study suggested by OND provides a path forward but does not address efficacy.  Rather, if the wear study is successful, Twirla’s safety and efficacy, including the Pearl Index, will need to be reviewed by FDA after the Company resubmits the NDA for Twirla. This is an issue that DBRUP plans to bring to the Advisory Committee after the adhesion issue has been resolved.


Notwithstanding this temporary setback, analysts tracking the stock believes that the company business profile is marked by significant revenue potential & the company’ strong fundamentals are well poised for value creation. Per, Their average twelve-month price target is $4.00, suggesting that the stock has a possible upside of 318.76%. The high price target for AGRX is $5.00, and the low-price target for AGRX is $3.00. There are currently two hold ratings, and four buy ratings for the stock, resulting in a consensus rating of “Buy.” Considering all this, the company is in a favorable risk-reward position, and value investors should consider exposure in this sector as the backdrop remains favorable.


Below are the excerpts of recent analyst rating on the script:

As per


About Twirla: The company’ lead product candidate, Twirla® (levonorgestrel/ethinyl estradiol transdermal system) or AG200-15, is an investigational low-dose, non-daily, prescription contraceptive. Twirla is based on the company’ proprietary transdermal patch technology, called Skinfusion®, which is designed to allow drug delivery through the skin.



In addition to Twirla, the company is also developing a pipeline of other new transdermal contraceptive products, including:

  • AG200-SP, a regimen designed to allow women to experience shorter, lighter periods
  • AG200-ER, a regimen designed to allow a woman to extend the length of her cycle
  • AG200-ER (SmP), a regimen designed to allow a woman to extend the length of her cycle and experience shorter, lighter periods
  • AG890, a progestin-only contraceptive patch intended for use by women who are unable or unwilling to take estrogen



Second Quarter 2018 Highlights:

  • Cash and cash equivalents:  As of June 30, 2018, Agile had $22.5 million of cash and cash equivalents compared to $35.9 million of cash and cash equivalents as of December 31, 2017.  In June 2018, the Company announced a reduction in its workforce and reductions on other planned operating expenses as the Company pursues formal dispute resolution.  As a result of these planned cost reductions, the Company believes its cash and cash equivalents as of June 30, 2018, will be sufficient to meet its operating requirements into the second quarter of 2019.
  • The Company will require additional capital to fund operating needs for the remainder of the second quarter of 2019 and beyond, including among other items, the completion of its commercial plan for Twirla, which primarily includes validation of the commercial manufacturing process and the commercial launch of Twirla, if approved, and advancing the development of its other potential product candidates.
  • Research and development (R&D) expenses:  R&D expenses were $2.4 million for the quarter ended June 30, 2018, compared to $3.8 million for the comparable period in 2017.  The decrease in R&D expenses was primarily due to decreased clinical development expenses as the Company’s Phase 3 SECURE clinical trial for Twirla completed the close-out phase during 2017 as well as decreased regulatory expenses related to the preparation of the Company’s NDA resubmission and response to the FDA’s February 2013 CRL in June 2017.
  • General and administrative (G&A) expenses:  G&A expenses were $2.3 million for the quarter ended June 30, 2018, compared to $3.2 million for the comparable period in 2017.  The decrease in G&A expenses was primarily due to the suspension of pre-commercialization activities as a result of the receipt of the CRL in December 2017.
  • Net loss:  Net loss was $5.3 million, or $0.16 per share for the quarter ended June 30, 2018, compared to a net loss of $7.4 million, or $0.26 per share for the quarter ended June 30, 2017.

Key risk factors and potential stock drivers:

  • Successful completion of the upcoming milestones would lead future direction for the company.
  • The near to medium term performance of the company is largely dependent on the success of Twirla. Therefore, any adversities about the same might adversely impact the overall investor sentiments.
  • The company operation is still in the clinical development stage. Therefore, its ability to maintain its present strong liquidity and financial flexibility and to fund its incremental capital requirements without any significant cost or time overruns would remain a critical challenge for the company.
  • AGRX operates in a highly competitive and dynamic space and only time would differentiate between real winners and laggards. Some of its competitors may have longer operating histories and greater resources than AGRX.
  • As far as choosing an option with a relative advantage is concerned, AGRX is a preferred choice with upside potential.


Stock Performance


  • On Friday, Oct 19th, 2018, AGRX closed at $0.9552, with an average volume of 5.56 million shares exchanging hands. Market capitalization is $32.837 million. The current RSI is 69.52
  • In the past 52 weeks, shares of AGRX have traded as low as $0.2310 and as high as $5.3300
  • At $0.9952, shares of AGRX are trading above its 50-day moving average (MA) at $0.42 and above its 200-day moving average (MA) at $1.69
  • The present support and resistance levels for the stock are at $0.73 & $1.09 respectively.



Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
17B Disclosure
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.