Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q1 2020 Earnings Conference Call - Final Transcript

May 11, 2020 • 04:30 pm ET

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Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q1 2020 Earnings Conference Call - Final Transcript

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Presentation
Operator
Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Aimmune First quarter 2020 Earnings Call. [Operator Instructions] After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions]

I would now like to turn the call over to DeDe Sheel. Please proceed.

Executive
DeDe Sheel

Thank you, [Indecipherable]. Good afternoon, and thank you for joining us today to discuss Aimmune's First Quarter 2020 financial results and recent operational highlights. Today's call will be webcast, which 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 questions. Daniel Adelman, our Chief Medical Officer, will join us for the 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 effects of COVID-19 on our business and financial condition; the potential benefits of PALFORZIA; the commercial launch of PALFORZIA, including engagement of our commercial field team with allergists; the timing for when allergy practices may reopen; timing for initiating direct-to-consumer mobilization activities and timing for payers in the United States to add PALFORZIA to formularies; the review period for PALFORZIA by the EMA and Swissmedic; development plans for AR201 and the multi-tree nut program; potential timing for completion of enrollment of our Phase 3 POSEIDON clinical trial for PALFORZIA; projection of cash spend for the remainder of 2020; the sufficiency of Aimmune's cash resources; plans to explore the use of AIMab7195 as an adjunct to our CODIT programs; the potential benefits of using biologics as adjuncts to CODIT and Aimmune's expectations regarding potential applications as a CODIT approach to treat life-threatening food allergies.

Risks and uncertainties that contribute to the uncertain nature of forward-looking statements include the effects of the COVID-19 pandemic on our business and financial condition; the expectation that Aimmune will need additional funds to finance operations; Aimmune's dependence on the success of PALFORZIA; Aimmune's ability to build a commercial field organization and distribution network; the degree of acceptance of PALFORZIA among physicians, patients, healthcare payers, patient advocacy groups and the general medical community; Aimmune's ability to obtain favorable coverage and reimbursement from third-party payers for PALFORZIA; Aimmune's ability to implement and comply with REMS for PALFORZIA; Aimmune's or any of its collaborative partners' ability to initiate and or complete clinical trials; the unpredictability of the regulatory process; the possibility of the Aimmune's or any of its collaborative partners' clinical trials will not be successful; the reliance on third-party for the manufacturer of PALFORZIA and our product candidates; possible regulatory developments 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