Teligent, Inc. (NASDAQ:TLGT) Q3 2019 Earnings Conference Call - Final Transcript
Nov 04, 2019 • 04:30 pm ET
Thank you. [Operator Instructions] And our first question comes from the line of Matt Hewitt with Craig Hallum Capital. Your line is now open.
Good afternoon and thank you for taking the questions.
With pleasure. Hi, Matt.
Hi. So first question on ranitidine. And I'm going to ask you to speculate a little bit. But as you look at the current situation in the market for that product and the questions related to NDMA and the desire, I would think to get a stable product into the market. Is it safe for us to assume that the FDA is incentivized to come in and get your inspection completed as quickly as possible rather than waiting the four months to come in?
Hey, Matt. So, look, I think, that the FDA is really working through a complicated issue here with respect to the molecule and to the science behind detecting the potential impurity and the risk to patients and their safety. So it is obviously a complex problem. Most of the effort recently of course has been focused on the oral form of this drug, in its OTC form and in its Rx form, and obviously, making sure that the standards are there to do the analytics to determine whether this drug is present, which we're talking about parts per billion, has been really complex. So I commend the FDA's efforts on this part.
The injectable piece of this is still outstanding. If you reviewed the FDA's communications this weekend, they gave an update in terms of where they were with the various reporting and testing that's been ongoing, noting that testing of the injectable form is still out there. I think that the FDA will always act to be expeditious around patients and patient safety, and we hope that we're part of that solution.
All right. And then shifting gears a little bit. So once the FDA has come in, they've cleared the facility, you've gotten that first product approved. How should we be thinking about cadence for your injectable pipeline. I think last quarter, you talked about having 13 products to 15 products ready to file and potentially launch once approved. But how should we be thinking about cadence once that facility is cleared?
Yeah. So if I go back to the comments that I made in the second quarter call, what I said was that the team had already developed five injectable drugs to go into the facility with the goal to drive that cadence up to eight to 10 products in the coming months as the team continues to build speed. That's still our plan and that's what we're going to execute as we work into 2020.
All right. And then last one, as we think about maybe 12 months from now and I'm not asking for guidance, but as we think about those products starting to layer on, particularly on the sterile injectable side. How will that impact your gross margin? I mean, where do