Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q3 2019 Earnings Conference Call Transcript

Nov 06, 2019 • 04:30 pm ET

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Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q3 2019 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the Aimmune Therapeutics Third Quarter Earnings Call. [Operator Instructions] Thank you.

I would now like to turn the conference over to your host, Ms. DeDe Sheel, Vice President of Investor Relations. Please go ahead, madam.

Executive
DeDe Sheel

Thank you, Katrina. Good afternoon, and thank you for joining us today to discuss Aimmune's third quarter 2019 financial results and operational highlights. Today's call is being webcast, and replay will be available on our corporate website at Aimmune.com.

Joining me on the call today are Dr. Jayson Dallas, President and Chief Executive Officer; Andrew Oxtoby, Chief Commercial Officer; and Eric Bjerkholt, Chief Financial Officer. After our prepared remarks, we will open the call for Q&A.

Before we begin, I would like to remind you that during today's call and Q&A session, we will be making forward-looking statements. These forward-looking statements include Aimmune's expectations regarding the potential benefits of PALFORZIA, including potential benefits for patients, caregivers and allergists, potential approval of PALFORZIA by the FDA and the EMA, including approval timelines, the potential commercial launch of PALFORZIA including launch timelines, the potential REMS for PALFORZIA, the potential receipt of comments to the MAA, the first potential market in Europe, the timing for payers in the United States to add PALFORZIA formularies, potential timing for completion of enrollment for Aimmune Phase 2 clinical trial for AR201, the sufficiency of Aimmune's cash resources, Aimmune's ability to access an additional $130 million from its credit facility, and Aimmune's expectations regarding potential applications of the CODIT approach to treating life-threatening food allergies.

Risks and uncertainties that contribute to the uncertain nature of the forward-looking statements include the expectation that Aimmune will need additional funds to finance operations, Aimmune's or any of its collaborative partners ability to initiate and/or complete clinical trials, the unpredictability of the regulatory process, the possibility that Aimmune's or any of its collaborative partners' clinical trials will not be successful, Aimmune's dependence on the success of PALFORZIA, the reliance on third parties for the manufacture of our product candidates, possible regulatory development in the United States and foreign countries, and Aimmune's ability to attract and retain senior management personnel.

These forward-looking statements are based on assumptions and are subject to risks and uncertainties that can cause actual results to differ significantly from those stated on this call. Given these risks and uncertainties, you should not place undue reliance on these forward-looking statements. Please refer to the Company's quarterly report on Form 10-Q for the quarter ended September 30, 2019, for some of the important risk factors that could cause actual results to differ materially from the forward-looking statements made on this call.

Except as required by law, Aimmune disclaims any obligation to publicly update or revise any information to reflect the events or circumstances that occur after this call. Finally, I'd like to point out that Aimmune's food allergy treatments are investigational and are not FDA approved.

And now I'll turn the call over to Jayson.

Executive
Jayson Dallas

Thanks, DeDe, and