$AGRX DD by u/CatchTheCleanUpSet

This is taken from the reddit sub r/pennystocks

I’ve been watching this one for a few months now and I wanted to share what I’ve found so far. I see this stock at least doubling in the next few months as they launch their new and only FDA approved product (planned for Q4 2020): Twirla (a female contraceptive patch). I also see an opportunity for a larger company (e.g. Johnson and Johnson (JNJ)) to buy them out and be able to market the product more effectively given their larger resources which I think would more than double their stock price.

I’ll try to keep the highlights below brief. And I’d appreciate all feedback (good or bad) from my fellow future (or current) Lambo and yacht owners. Please include links/references for your evidence/position.

Twirla: Its Competition and Product Differentiation:

Twirla was approved by the FDA on February 14th, 2020. Twirla is now the only other contraceptive transdermal patch available in the US. Xulane is the other patch available in the US (made my Mylan , MYL, stock price currently $16.10 who has several products for sale and drugs in their pipeline: https://www.biopharmcatalyst.com/company/MYL) . Evra is available in Canada, UK, and Europe (https://en.wikipedia.org/wiki/Contraceptive_patch). The main differentiating factor of Twirla from its competition is the reduction of known side effects compared to Xulane which “is associated with health concerns such as increased risk of blood clots in the legs and lungs.” And “Agile Therapeutics, the women’s healthcare company behind Twirla, saw an unmet need in the market for a low-dose hormonal contraceptive patch. This market gap lead to the development of their newly formulated contraceptive patch, Twirla.” (https://birthcontrolpharmacist.com/2020/02/29/twirla-a-new-contraceptive-patch/)

The chemicals used (levonorgestrel and ethinyl estradiol) for Twirla are “ingredients [that] have a well-understood efficacy and safety profile in oral contraceptives” (https://agiletherapeutics.com/lead-product-candidate/) according to the AGRX website. Levonorgestrel and ethinyl estradiol have been used for years in tablet/pill form to prevent pregnancy.

Agile uses its patented SkinFusion Technology for the delivery of the chemicals into the human body (https://agiletherapeutics.com/skinfusion/) in patch form.

(https://www.prnewswire.com/news-releases/agile-therapeutics-announces-issuance-of-new-patent-for-its-skinfusion-transdermal-delivery-device-263958341.html).

Twirla retail cost (without insurance) – $159.75 (Form 8-K SEC Filing June 30th, 2020: https://ir.agiletherapeutics.com/node/9946/html)

Xulane cost (without insurance) – ranging $135 – $210 (there seems to be a large range online)

https://www.nurx.com/birth-control/patch/xulane/

https://www.plannedparenthood.org/learn/birth-control/birth-control-patch/how-do-i-get-birth-control-patch

AGRX Company Highlights:

– Founded 1997.

– Only ~14 employees including interns and such according to LinkedIn and Google searches.

– AGRX has only one that is FDA approved and ready to sell: (https://www.biopharmcatalyst.com/company/AGRX)

– AGRX has other drugs in its pipeline (Phase 1 and 2) using the same patented patch technology with Phase 2 AG890 (Progestin-only contraceptive patch) aiming to meet the needs of women that are at higher risk of using levonorgestrel and ethinyl estradiol products which Twirla doesn’t capture: (https://agiletherapeutics.com/product-pipeline/)

– Joined the Russel 2000 and Russel 3000 index as of 6/29/20. (https://www.globenewswire.com/news-release/2020/06/16/2048718/0/en/Agile-Therapeutics-to-Join-Russell-3000-and-2000-Indexes.html).

– Completed share offering which diluted the stock in February 2020 so it’s NOT likely to occur again in the near future (https://www.fool.com/investing/2020/02/21/why-agile-therapeutics-stock-is-falling-today.aspx). “Based on our current business plan and ability to get Twirla launched, we believe that our cash and cash equivalents as of March 31, 2020 will be sufficient to meet our projected operating requirements through the end of 2021” from the Q1 Earnings Report (https://ir.agiletherapeutics.com/node/9856/html).

– Target price from analysts from CNN and WSJ is $6 and $8:

https://money.cnn.com/quote/forecast/forecast.html?symb=agrx

https://www.wsj.com/market-data/quotes/AGRX/research-ratings

– Hedge Fund Positions have recently increased (https://finance.yahoo.com/news/hedge-funds-never-bullish-agile-195250130.html)

– Planned sales force hiring in Q2 2020 according to their Q1 Earnings Report…Q2 is over and I don’t see any job positions for a sales team opened up in my searches on Google, Indeed, etc. This suggests a delay in their schedule for Twirla commercialization (presented as a possibility in the Q1 Earnings Report due to COVID) or because they are planning for a buyout. Sales team will be a contract through inVentiv Commercial Services, LLC and I’m not seeing them hiring for Twirla sales either but I’m not sure if that info can be found in the public domain.

– Manufacturing and commercialization is through contract with Corium, Inc.

– According to SEC filings and Q1 2020 Earnings Report sales of Twirla is expected in Q4 2020. “We intend to ship product to wholesalers in the fourth quarter of 2020. (Q1 Earnings Report)” I think this will be a catalyst for stock price movement.

– SEC Filings and Insider Trading have lots of Form 3s and Form 4s filed recently (https://ir.agiletherapeutics.com/financial-information/sec-filings/?auth_token=4683a640-010e-4a7a-99cd-103a9b4dbd64)

Executive Leadership Experience:

– CEO Al Altomari – previous experience with company buyouts as CEO of “Barrier Therapeutics (NASDAQ: BTRX) to GSK/Stiefel Labs for a 73% premium”. Has previous experience with Johnson and Johnson: “Prior to joining Barrier Therapeutics, Al Altomari served in numerous executive roles in general management, commercial operations, business development, product launch preparation and finance within Johnson & Johnson from 1982 to 2003.” And has commercialization experience of pharmaceutical products “including the pre-launch of ORTHO EVRA, the contraceptive patch.”

o LInkeIn Profile: https://www.linkedin.com/in/al-altomari-792577a

o Agile Executive Leadership: https://ir.agiletherapeutics.com/corporate-governance/management/?auth_token=4683a640-010e-4a7a-99cd-103a9b4dbd64

– The rest of the Executive Leadership and Board of Directors are loaded with experience at large pharmaceutical companies (several with many years JNJ) that are well suited for launching Twirla commercially or have the ties to help facilitate a company buyout.

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