Playing To Win: From The Brink Of Bankruptcy And Back

By Al Altomari

As the CEO of a small, specialty pharmaceutical company, I’m often asked to comment on how innovation can be encouraged within the industry and how, as an industry, we can better ensure the success of early-stage compounds. Both of these questions are intimately tied to financing. Based upon my experience at Agile Therapeutics, I would like to share with you how our company was able to emerge from the brink of closing its doors to having two late-stage pharmaceuticals nearing commercialization.

A Future In Jeopardy
Agile Therapeutics was founded in 1997 with the goal of improving contraceptive options for women. From the beginning, we were focused on developing a high-quality product that met a real market need, and we took a good deal of time to ensure we were doing things right. However, while the concept of a low-dose hormonal contraceptive patch was attractive to investors, the lack of robust clinical data threatened our chances to obtain the additional funding we needed and the overall future of the company.

This was the situation when I became the chairman of the board in 2009. As a board, we realized that we needed to make a few fundamental changes. Our path began with securing pharmacokinetic data, which was a key stepping stone to our raising $45 million in Series B financing in 2010. Finally, I transitioned into the CEO position based on my background in commercialization, while we retained the previous CEO, Dr. Thomas Rossi, as an advisor to the board. With these steps, today Agile is well-positioned for the future.

I’d like to outline some of the key learnings we gained through this process.

Product
This may go without saying, but it is important to have the right product. In today’s market, that translates into a product that has an excellent safety profile, is supported by strong clinical data, and addresses an unmet market need. That is the basic foundation for commercial success.

Messaging
Although every product has nuances, one of the big things we learned was that investors need to hear a concise message tied to an obtainable objective. There is a lot of uncertainty in the pharmaceutical industry right now. It pays to develop a quality business plan and spend time refining how the company communicates its messages to stakeholders.

Standards
Drawing upon my 23 years’ experience with big pharma, I try to instill a “play-to-win” mentality throughout the company. Just as the big pharmaceutical companies do, it is critical that start-ups take the time and make calculated long- and short-term investments to ensure success. Spending on clinical studies, market research, and staffing can elevate your product from good to great. I think this is a value that is not always emphasized in smaller companies but often makes a huge difference.

Staffing And Partnerships
It is essential to identify the right talent. While all of us at Agile have big pharma experience, we also have a certain level of “scrappiness,” the ability to work hard and understand that no task is too small. I’ve found the greatest success in hiring individuals who have an understanding of the principles of a large corporation but also approach their work with an entrepreneurial spirit. This extends to your outside council and partners as well, who are an extension of your management team.

Data
If your product is the foundation, your data is the backbone of your company. When we were meeting with investors for Agile, we heard time and time again that they wanted to see definitive pharmacokinetic data and high-quality market research supporting the need for our products. The market will tell you what it is looking for. We heard the message loud and clear. In order to raise the funds we needed, we had to show potential investors the clinical support. It was at this point that we simultaneously invested in market research and finalized our Phase 2 data. In short, don’t underestimate the power of your data.

All of these points are foundational. In my mind, raising money in a difficult economy is no different from raising money at other times — you still need to ensure that the basics are in place, and from there it’s just a matter of meeting with people and sharing your story. Companies may find that they have to knock on a few more doors or have a few more meetings along the way, but money is always there, and a good product supported by a clear and concise path to meeting its intended goal will speak for itself.

About The Author
Al Altomari is the president and CEO of Agile Therapeutics and a member of the company’s board of directors. He has more than 28 years of experience in the pharmaceutical industry.