• Agile Therapeutics is preparing to launch their first FDA approved product, Twirla. If all goes well, Twirla could quickly establish a foothold in a $4.1B addressable market.
• Launching an FDA approved product is not easy and has plenty of unknowns. I point out some things to keep an eye out for before and after Twirla's launch.
• AGRX has been a great investment over the past two years and could provide additional upside. I discuss how I intend to manage my remaining shares and possibly reload on AGRX.

Agile Therapeutics (AGRX) remains on track to launch their flagship, Twirla, a once-a-week contraceptive patch. Since Twirla’s FDA approval, the company has been working hard to get their product on the U.S. market and is preparing to launch Twirla in the coming weeks. Agile has secured a supply chain, trained and positioned their contract salesforce, and has made some progress with payers to help ensure Twirla has a strong launch. However, there are a lot of unknowns when launching an FDA approved product, and 2020 has a way of amplifying the uncertainty. As a result, AGRX investors need to be vigilant as we await the launch and should have a plan for every conceivable scenario. I expect the market to provide an opportunity for investors to manage their position for a long-term investment.

I intend to review the company's pre-launch efforts to prepare Twirla for a highly competitive contraceptive market. In addition, I point out some critical matters that investors need to keep an eye out for once Twirla hits the market. Finally, I discuss my strategy for managing my remaining AGRX shares and why I am still looking to hold for the long term.

Figure 1: Agile’s Strategy (Source: AGRX)

Preparing For Launch

Agile expects Twirla’s launch to happen in Q4 of 2020, and they still believe that they will hit that goal. There are several major to-dos or pre-launch checklist items that need to be addressed before the product hits the market.

First and foremost is Twirla’s supply chain components, which include manufacturing of the product and the distribution network to get Twirla to the patients. Agile’s manufacturing partner, Corium International (CORI), has completed the pre-validation batch of Twirla, and expects to finalize the three validation batches that will be used in a commercial launch. All three of these batches are expected to be out on the market by year-end. What is more, Agile has been working on their distribution network by contracting three major U.S. wholesalers along with several regional wholesalers. So, it appears that Agile has already built a supply chain infrastructure that will support their commercial efforts.