Teligent, Inc. (NASDAQ:TLGT) Q3 2019 Earnings Conference Call - Final Transcript

Nov 04, 2019 • 04:30 pm ET

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Teligent, Inc. (NASDAQ:TLGT) Q3 2019 Earnings Conference Call - Final Transcript

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Presentation
Executive
Jason Grenfell-Gardner

positions, however, continue to rely on challenging supply chain dynamics as our suppliers work to recover their production volumes after the disruptions earlier this year.

As a result, inventory has often been delayed leading to volatility in revenue. Although, our team has managed to execute through this and attempted to build safety stocks, we have widened our revenue guidance for the fourth quarter to accommodate any potential delays in releases that could impact shipments to customers. Although, not all of this is in Teligent's control, our team will work to minimize any potential impact.

Now let me address the three issues that have been announced subsequent to the quarter. First, the review of non-core assets; second, the Series B fundraising; and third, is the filing of the prior approval supplement for ranitidine hydrochloride injection.

On October 1st, we announced the appointment of SVB Leerink to conduct a review of the Company's assets following the receipt of unsolicited inbound interest. We believe it's in shareholders' best interest to explore the potential logic of a divestiture of some of these assets if the consideration accelerates the Company's injectable growth plan and facilitates a reduction in overall indebtedness.

Second, we executed the Series B note fundraising last week, which was an important part of our ongoing strategy to manage the Company's balance sheet. Damian, will provide a more fulsome summary of that project, but I'm grateful to our investors and advisers who helped execute this transaction.

Finally, we submitted the prior approval supplement for ranitidine hydrochloride injection that we anticipate will trigger an FDA inspection of the sterile manufacturing operations of the Company's site in Buena, New Jersey. As many of you are aware, there's been a recent concern around the ranitidine molecule as a result of the potential for N-nitrosodimethylamine or NDMA impurities, a known human carcinogen.

Teligent took significant extra steps, both with its raw material supplier and with its own finished product, to ensure that our product complies with the FDA's approved safe ranges for NDMA. While these extra steps took time, we've always maintained that product quality and patient safety will come first to Teligent.

This first submission is exciting for all of us. Under GDUFA guidelines, the FDA aims to inspect 90% of facilities requiring inspection as a result of supplements within four months. We look forward to getting onto the next stage of our development plan as we execute further transfers into the site of approved products that we already own and our internally developed pipeline of sterile injectable products out of our six development team.

One last thing before I turn over to Damian. I'd like to update you on what we call our generic orphan drug. Based on recent interactions with the FDA, we believe that our product will be approvable at our GDUFA goal date in late December. Although, we will not be the first to market with the generic version of this drug, we believe that the market still holds significant opportunity for