Apellis Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by and welcome to Appellee's second quarter 2021 financial results conference call. At this time, all participants are on a listen-only mode. After this speaker's presentation, there will be a question and answer session. To ask a question during this session, you will need to press the star then the one key on your touch-tone telephone. Please be advised that today's conference may be recorded. If you recall all of your assistants, please press star then zero. I would now like to hand the conference over to your speaker host, Meredith Kaya, Senior Vice President of Investor Relations. Please go ahead.

Good afternoon, and thank you for joining us to discuss Appellus' second quarter 2021 financial results. With me on the call are co-founder and Chief Executive Officer, Dr. Cedric Francois, Chief Commercial Officer, Adam Townsend, Chief Medical Officer, Dr. Federico Grossi, and Chief Financial Officer, Tim Sullivan. Before we begin, I would like to point out that we will be making forward-looking statements that are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors discussed in our SEC filings for additional detail. Now, I'll turn the call over to Cedric.

Thank you, Meredith. And good afternoon to everyone joining us today for our conference call. Also, a quick welcome to Meredith, who joined Apedis earlier this month and will be leading our investor relation efforts. The second quarter was an exceptional period for Apedis, highlighted by the FDA approval of Empaveli or Pexetacoplan, which is the first targeted C3 therapy. Empaveli was approved with a broad label for the treatment of adults with paroxysmal nocturnal hemoglobinuria, or PNH, and it represents the first new class of complement medicine in nearly 15 years. The approval of Empaveli was a tremendous achievement for the PNH community and for Atelis, and I am very proud of our team for advancing this transformational medicine. Our commercial launch is off to a strong start, and our chief commercial officer, Adam Townsend, will share additional details shortly. The Empaveli approval was quickly followed by more good news, with positive results from the Phase III PRINCE study of our targeted C3 therapy in treatment-naive PNH patients. Together with the Pegasus data, the PRINCE results reinforce the potential for Empaveli to elevate the standard of care for all patients with PNH. And PNH is only the start of what is possible by targeting C3. In June, we hosted an R&D day where we showcased our growing pipeline across rare disease, neurology, and ophthalmology. Our ambition is to be a global leader in complement over the long term, and we unveiled multiple new molecular entities across several modalities to deliver on that goal. In addition to advancing Empatheti in four registrational programs with our partner SOBI, We plan to transform the treatment of rare, complement-driven diseases by developing new product candidates for existing and new indications and further enhancing the patient experience. In neurology, where C3 plays a key role in a wide range of neurodegenerative conditions, our world-class research team is pioneering targeted C3 therapies to help patients with these devastating diseases. And in ophthalmology, where we aim to be number one in the retina, we look forward to the phase three results from pexetacoplum in geographic atrophy, or GA. In addition, we are advancing novel molecular entities for GA, wet AMD, and intermediate AMD. At our R&D day, we also announced an exclusive research collaboration with Beam Therapeutics, to apply BEAM's proprietary base editing technology to discover novel treatments for complement-driven diseases. Complement is a new frontier for base editing, and we look forward to working together with BEAM. We will explore base editing silencing and other approaches that may have the potential to modulate complement in the eye, the liver, and the brain. Our shared vision is to develop one time, curative therapies for a wide range of debilitating diseases. We are thrilled with the breadth and the depth of our expanded pipeline, which we believe positions Apedis to be a global leader in complement today, tomorrow, and in the future. Looking ahead, we are optimistic heading into the top-line results from the Phase III Derby and Oaks studies of Pexita Copeland for the treatment of GA. This key readout in September is a potentially transformative event for the more than 5 million patients worldwide currently living with GA, as well as for the millions of patients with wet AMD, the majority of whom will develop atrophy over time. Feedback from the retinal community shows great enthusiasm for Pexita Copeland and the prospect of finally having the first potential treatment for people living with GA. I will now turn the call over to Adam Townsend to share more about our ongoing commercial launch of Empaveli for P&H.