Agile Therapeutics, Inc. (NASDAQ:AGRX) Q3 2023 Earnings Call Transcript

Alfred Altomari: Yes. Thanks. Thanks, Naz. Yes, excellent question. I mean, just to reeducate everybody, Naz, alluding to the TRI Departments. It’s really three departments in the government that regulate our insurance industry and/or the Affordable Care Act, Health And Human Services, Treasury and believe it or not Labor. So, probably goes back to our days as in the unionized systems. But if you’re thinking them as the TRI agencies, the quarterback is how is helping Human Services since we’re in football season, I can use quarterback. Health and Human Services, that’s the primary responsibility of issuing the guidelines. So, unlike, when we see what’s going on in our country, this doesn’t have to go to the floor of Congress or the Senate to be debated.

These are guidelines that need to be issued by Health and Human Services to clarify and really put into guidance, if you will, what Biden said in his in the executive order. What Biden said in his executive order that gets us excited is, on the Affordable Care Act, if a physician, if we weren’t on formulary or a drug wasn’t on formulary, physicians had to go through this onerous prior authorization letters of medical necessity, which is in direct violation of Affordable Care Act, at least a spirit of what that act should be. So, to make the system work better, Biden suggested in, Congress believes they’re right saying, let’s just make this easy. If you have an approved drug for contraception that doesn’t have a generic equivalent, you get, no cost sharing or in effect your own formulary.

That just makes the whole system work better. And then when you lose your exclusivity, it’s up to the plan to decide whether your own formulary though different than other formulary decisions. So, that’s what we’re waiting for. We’re waiting to see what Congress and the oversight committees had recommended get adopted by Health and Human Services. And the reason I’m bullish Naz, it doesn’t have to go to the floor of either house for debate. It gets into the guidelines. And then, to be fair balance, we’ve got to see the insurance companies and their PBMs adopt these guidelines once and for all. And we’re hopeful that after, in this time, the President getting involved in this, we hope that they’ll comply. So, that’s the watchful waiting we’re in right now.

So, we believe Health and Human Services is getting a lot of inquiries about this, lot of attention. The Secretary [Pacira] (ph) is certainly aware of this. He was in California where he put a lot of these laws in place, and then the interesting party is married to an ObGyns. So I’d hopefully, he’s getting a little help at home on this issue of what an ObGyns is going through.

Naz Rahman: Thanks for that color. And on that point, based on your contacts and everyone you’ve been speaking to, do you think there’s a greater sense of urgency to get this done. Like, let’s call in the first half of ’24 just because we’re entering an election cycle to, like, I guess, mitigate —

Alfred Altomari: Yes.

Naz Rahman: The risk administration change?

Alfred Altomari: Yes. Now I’ll go into the world of what I believe. And, yes, I think I believe that personally, and I believe our management team believes that from a practical point of view, it’s a lot easier doing it ahead of election cycle. This is something you don’t want to leave on the table. So, yes, if there seems to be a sense of urgency of kind of getting your house in order, on the eve of an election, so, yes, I believe that plays into it. Again, I want to be fair balanced. There’s two other issues that take a lot of mind space down DC, clearly abortion, takes a lot of reproductive health mind space this issue. And now we have an over to counter product for the first time. How does that get reimbursed? And that’s a very complicated subject.