Halozyme Therapeutics, Inc. (NASDAQ:HALO) Q2 2020 Earnings Conference Call - Final Transcript
Aug 10, 2020 • 04:30 pm ET
Good afternoon, everyone. I would now like to turn the conference over to Al Kildani, Vice President of Investor Relations and Corporate Communications for Halozyme Therapeutics. Mr. Kildani, please go ahead.
Good afternoon and welcome to our Second Quarter 2020 Financial Results Conference Call. In addition to our press release issued today after the close, you can find a supplementary slide presentation that will be referenced on today's call in the Investor Relations section of our website.
Leading the call today will be Dr. Helen Torley, Halozyme's President and Chief Executive Officer, who will provide an update on our business; and Elaine Sun, our Chief Financial Officer who will review our financial results for the second quarter 2020.
During the call we will be making forward-looking statements. I refer you to our SEC filings for a full listing of the risks and uncertainties.
I'll now turn the call over to Helen.
Thank you, Al. I'm delighted to report our second quarter results and provide you with an update on the recent exciting developments at Halozyme that are positioning the company for sustained growth in revenues, earnings and cash flow in the coming years. These developments include three major market regulatory approvals for blockbuster oncology drugs utilizing our ENHANZE direct delivery technology and our first quarter of what we expect to be sustained profitability going forward.
Now before I get to some of these exciting second quarter developments, I'd like to provide a brief update on the impact of COVID-19 on our business. As an organization, we continue to operate effectively with the majority of our employees working from home. We expect this will continue for the foreseeable future. Importantly, our suppliers also continue to operate withour interruptions related to COVID-19.
On our first quarter call, we indicated that based on partner feedback, we anticipated that some partner development program starts would be delayed by one to two quarters and that some trial enrollment had been impacted. Any potential for impact on FDA and EMA review times was unknown at that time.
I'm very pleased to update today the progress has been made on multiple programs during the second quarter, and based on latest partner feedback provided just in the last few weeks, we project a total of nine new clinical trial start in 2020 with one additional new trial start date still uncertain.
From a regulatory standpoint, we were obviously pleased by the speed with which the FDA was able to approve Janssen's DARZALEX FASPRO and also Roche's Phesgo. The Phesgo approval was four months ahead of the October PDUFA date and the FDA cited that this was due to desire to expedite oncology product development. In Europe, the EMA timeline for DARZALEX SC approval also tracked ahead of expectations. Now these current expectations for 2020 reflect the latest feedback we've received from our partners about their plans for their ENHANZE based products in 2020. Given the inherent uncertainty of the COVID-19 pandemic, our partners may update or change their plans