Akebia Therapeutics, Inc.

Thank you. Thank you for standing by. My name is Andrea and I will be your conference operator today. At this time, I would like to welcome everyone to the KBS second quarter 2024 financial results. All lines have been placed in mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star followed by the number one in your telephone keypad. If you would like to withdraw your question, Press star 1 again. I would now like to turn the call over to Mercedes Carrasco, Senior Director, Investor Relations. Thank you. Please go ahead.

Thank you, and welcome to Atebia's second quarter 2024 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, August 8th, detailing our second quarter financial results And that release is available on the investor section of our website. For your convenience, a replay of today's call will be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, Nick Grund, Chief Commercial Officer, and Eric Ostrowski, Chief Financial and Business Officer. I'd like to remind everyone that this call includes forward-looking statements. Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on August 8th, as well in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce CEO John Butler.

Thanks, Mercedes, and thanks, everyone, for joining us today. Since the VASIO FDA approval in late March, virtually the entire company has been diligently focused on its commercial launch. Now, Nick's going to walk you through the details shortly, but the punchline is that in the four weeks since we spoke to you last, we've made significant progress on our key launch initiatives, which are first, driving prescriber demand, Second, contracting effectively with dialysis organizations. And third, advancing plans to generate clinical data that could demonstrate potential additional benefits of Vafsio. As recently announced, we filed our Tdapa application in June and are now about five months away from making Vafsio available in the market. Our entire organization is incredibly energized by this upcoming event. We're encouraged by the strong reception for Vafsio from the medical community. The excitement around Vafsio was evident in two physician advisory boards we recently hosted. What's especially interesting is that these are physicians we haven't worked with in the past and are new to the Vafsio story. The overwhelming response was that they're ready for a new choice in anemia management for dialysis patients. Our medical affairs team has been supporting dialysis organizations as they work to put Vafsio clinical protocols in place ahead of Tdapa. Today, we have a full complement of MSLs who are actively engaged in physician education, armed with a wealth of clinical data, including the Vatadustat Phase 3 New England Journal publications, as well as the additional data we've generated to support healthcare providers' understanding and utilization of the product. Similarly, our commercial team has also been making good progress. Our field sales team is connecting with prescribers to drive awareness and demand. As we expand these discussions, physicians are very consistent in where they expect to use the product initially. The focus is on home patients as well as patients on the highest doses of ESAs. These are the segments where physicians attribute the greatest unmet need, and they total more than 200,000 patients. We believe prescribers will expand utilization of AFSEO beyond these patient groups after gaining experience with the product, and seeing the benefits of Vafsio for these initial patients. We're also very focused on the longer-term growth for Vafsio. Generating new data to potentially expand the benefits of the product is critical. A key component of our strategy is to continue to generate this clinical data in collaboration with dialysis organizations. We're deeply engaged with DOs in study design, and believe these studies may meaningfully contribute to continued growth of Vafsio post-Tdapa in the dialysis population. We need to continue to generate important clinical data for Vafsio to continue to move towards our goal of becoming a new standard of care. Think of it this way. Today, we're targeting the Tdapa patient population with a premium price. Once Tdapa ends in 2027, will have a price consistent with the ESAs, but will target the entire dialysis market, over 500,000 patients, and approximately $1 billion today. New data, along with the positive experience over the TDAPA period, will be central to meeting our goal. The market for VASIO and dialysis is significant, but let's also talk about potential expansion. Circling back to physician interest in VASIO, An unsurprising additional point continues to come up, both in the advisory boards I mentioned earlier and in virtually every conversation we have with prescribers. Physicians see a clear and obvious unmet need in the treatment of anemia in CKD patients not on dialysis. We agree. Accordingly, we've prioritized Vafsio label expansion for non-dialysis CKD patients. As we've said previously, we expect to provide a more detailed update on this initiative by the end of the year. Now, let me turn it over to Nick to talk about our commercial progress.