Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q2 2020 Earnings Conference Call - Final Transcript

Jul 30, 2020 • 04:30 pm ET


Aimmune Therapeutics, Inc. (NASDAQ:AIMT) Q2 2020 Earnings Conference Call - Final Transcript


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Ladies and gentlemen, thank you for standing by, and welcome to the Aimmune's Second Quarter 2020 Earnings Conference Call. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions]

I would now like to hand the conference over to one of your speakers today, Ms. DeDe Sheel, Vice President of Investor Relations. Ma'am, please go ahead.

DeDe Sheel

Thank you, Michelle. Good afternoon, and thank you for joining us today to discuss Aimmune's Second Quarter 2020 Financial Results and Recent Operational Highlights. Today's call will be archived, and a replay will be available on our corporate website at Joining me on the call today are Dr. Jayson Dallas, President and Chief Executive Officer; Dr. Daniel Adelman, Chief Medical Officer; Andrew Oxtoby, Chief Commercial Officer; and Eric Bjerkholt, Chief Financial Officer. After our prepared remarks, we will open the call for questions.

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 impact of COVID-19 on its business, including on the commercial launch of PALFORZIA and the company's clinical trials; the potential benefits of PALFORZIA, AR201 and AIMab7195; the commercial launch of PALFORZIA, including engagement of our commercial field team with allergists; the timing for when allergy practices may reopen; the timing for initiating direct-to-consumer mobilization activities and timing for payers in the United States to make policy decisions on PALFORZIA; the timing of a potential regulatory action date for the MAA for AR101 by the EMA and by Swissmedic; the timing of receiving data from a Phase II clinical trial for AR201; the planned timing for the announcement of data from the POSEIDON clinical trial for PALFORZIA; the timing for initiating a Phase I clinical trial of AIMab7195; plans to develop its multi-tree nut program; the sufficiency of Aimmune's cash resources; and the potential applications of the CODIT approach to treating life-threatening food allergies.

Risks and uncertainties that contribute to the uncertain nature of these 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 its 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, health care 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 the 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 that Aimmune's or any of its collaborative partners' clinical trials will not be successful; the reliance on third parties for the manufacture 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