Akebia Therapeutics, Inc.

Good day, and thank you for standing by. Welcome to the Akibia's third quarter 2022 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone. You will then hear an automated message advising your hand is raised. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Mercedes Carrasco, Senior Director of Corporate Communications. Please go ahead.

Thank you. Thank you, and welcome to the TBA's third quarter 2022 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 3rd, detailing our third 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 also be available on our website after we conclude. Joining me for today's call, we have John Butler, Chief Executive Officer, and Dave Spellman, Chief Financial Officer. Before we begin, 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. Additionally, information describing these risks is included in the financial results press release that we issued on November 3rd, as well as in the risk factors and management discussion and analysis section of our most recent annual and quarterly reports filed with the SEC. The forward-looking statements on this call speak only as to the original date of this call and, except as required by law, we do not undertake any obligation to update or revise these statements. With that, I'd like to introduce our CEO, John Butler.

Thanks, Mercedes, and thank you all for joining us this afternoon. Since our last update, our team has been laser-focused on work that aligns to Aqibia's three strategic pillars. First, we're working to drive Arixia revenue while managing costs. And this quarter, we're pleased to again report an increase in net revenue for Arixia over the third quarter of 2021. Second, we continue to support Vatadustat globally. I'll provide more color on the regulatory review processes for Vatadustat as a treatment for anemia due to CKD. Our third pillar is to thoughtfully invest in our pipeline. I'm pleased with the progress we've made with respect to our pipeline, particularly as it pertains to our work in the area of HIF-based science. but today I'll just say a few words about our next steps in continuing to explore Vatadustat as a treatment for acute respiratory distress syndrome. We recognize that we won't have the opportunity to invest in that pipeline and build that long-term value unless we continue to drive financial stability today. Gabe will share more specific details about the financial results, but there are two important headlines in Q3. First, As I previously noted, we continue to see a year-over-year increase in Arixia net product revenue, which is driven by an increase in net price per pill. Second, our team has and is continuing to work to bring down operating costs. We reported a decrease in operating expenses compared to Q222, as well as versus the prior year quarter. Driving Arixia revenue and managing expenses positions Aqibia to make strategic decisions about our future. As we think about potential catalysts to add value, our most immediate is clearly Vatadustat. As we reported last quarter, we regained the rights to Vatadustat from Otsuka in the United States, Europe, China, Russia, Canada, Australia, the Middle East, and certain other territories. Akibia assumed full responsibility for the marketing authorization application, or MAA, submitted to the European Medicines Agency last October and in the United Kingdom, Switzerland, and Australia through the Access Consortium. We're excited about the value of potential approval of Vatadustat in these markets could bring to Akibia. Now based on a typical review timeline for an MAA, we're targeting a potential approval by the end of next quarter. We're eager to bring Vatadustat to patients impacted by anemia due to chronic kidney disease. Now while our team is leading the regulatory process, We do not expect to commercialize Vatadustat in Europe without a partner. Our process for identifying a partner for Europe is well underway. In the US, we recently submitted a formal dispute resolution request referred to as an FDRR with the FDA to appeal the issuance of the CRL for Vatadustat in March of 2022. The FDRR focuses on the favorable balance of the benefits and risks of Vatadustat for the treatment of anemia due to CKD in adult patients on dialysis. We've always believed that Vatadustat delivered a favorable balance of benefits and risks as a treatment for anemia due to CKD and continue to believe in the unmet need. Now, clinicians often publicly discuss the unmet need, as we heard again late last month during a cardiovascular and renal drug advisory committee meeting. And moreover, patients continue to share their experiences related to the burden of the disease. As we reported last quarter, we completed the end of review conference, which was beneficial to refine the issues for the dispute. Again, both the end of review conference and the FDRR narrowed on the dialysis patient population. And the FDRR focuses on the benefits and risks of Vatadustat in light of safety concerns expressed by the FDA in the CRL related to the rate of adjudicated thromboembolic events driven by vascular access thrombosis for Vatadustat compared to the active comparator and the risk of drug-induced liver injuries. Based on the typical FDRR process, AKIBI expects to receive response to its submission from the FDA by the end of this year. And of course, we'll share that outcome with you. It will be important for our long-term planning to have clarity on a potential path towards approval for Vatadusat in the U.S. In the meantime, we continue to explore other potential opportunities for the product that we believe could bring significant value. Recall in our last update we reported data related to Vatadustat as a treatment for ARDS. ARDS is a condition with few therapeutic options approved for intervention and a mortality rate for serious ARDS that can be over 40% according to multiple studies. We were encouraged by the data from a phase two investigator sponsored clinical study evaluating Vatadustat for the prevention and treatment of ARDS in subjects with COVID-19 and hypoxemia. Since that time, we've continued discussions on the design and timing of starting a follow-on placebo-controlled study in a broad ARDS population. We're working closely with UT Health Houston and the team that conducted the phase two study and incorporating FDA feedback on a protocol into the design. As I've said, our financial stability is critical as we invest thoughtfully in our pipeline. To that end, I'd like to compliment our team for their ongoing resilience. The team is committed to the three pillars that will drive our future. They're working to deliver near-term value through Orixia and Vatadustat, as well as create long-term value opportunities for Akibia. And with that, I'll turn to Dave to provide more details on our financial picture.

Thank you, John, and good afternoon, everyone. Our cash management objectives remain clear. Manage the company with existing cash resources and ongoing cash from operations. We've continued a concerted effort to maximize net product revenue, reduce operating expenses, and strengthen our balance sheet. Before I dive into the financials, I wanted to address our NASDAQ listing status. While John mentioned that we continue to identify ways to add long-term value, we are working through various options to manage our NASDAQ listing. We've applied to transfer the list of our common stocks in the NASDAQ capital market, and as usual, we'll provide material updates when available. Beginning with the Rixia net product revenue, we reported $42.2 million in the third quarter of 2022 compared to $36.8 million in the third quarter of 2021, a 14.9% increase. Total revenue is $49 million in the third quarter of 2022 compared to $48.8 million in the third quarter of 2021. Our commercial payer strategy continues to deliver top-line Erixia growth. While year-on-year net product revenue is up, we did report a 3.3% decrease in net product revenue from the second quarter of 2022, driven by lower inventories at our distribution partners as well as a continued contraction in the binder market. To expand on that point, I'll note that the phosphate binder market has declined 15% since the start of COVID, including nearly 6% from Q3 2021 to Q3 of 2022. Further, you likely have heard from the earnings calls of the country's biggest dialysis providers that the overall dialysis market is challenging right now, with the COVID impact and staffing challenges having real impact on their operations. COVID is still a very real challenge to everyone in the dialysis community. We have factored this into our long-term forecast, and we are unsure when the binder market will recover or even begin to grow again. But again, because of the contracting and payer strategies previously executed, we still believe net product revenues will continue to grow through LOE, but have some headwinds with these real market-related challenges. As such, we remain in a position to affirm our 2022 net product guidance of Eurexia. of $170 to $175 million. Cost of goods sold was $37.9 million in the third quarter of 2022 compared to $15.9 million in the third quarter of 2021. The increase compared to the prior year period was primarily due to a $13.2 million non-cash charge related to an increase in the liability for excess purchase commitments during the third quarter of 2022 and a $6 million non-cash benefit related to a decrease in the liability for excess purchase commitments in the third quarter of 2021, which did not reoccur. License, collaboration, and other revenue was $6.7 million for the third quarter of 2022 compared to $12 million for the third quarter of 2021. The decrease was primarily related to a reduction in the revenue from the termination of the U.S. and international collaboration agreements between Akebia and Otsuka in the second quarter of 2022, which was a one-time event. Just as we are committed to driving Arixia revenue, our cross-functional teams have worked to reduce spending, particularly in the areas of SG&A expenses. Our team is committed to running the company with the cash we have on hand plus future cash flows from Arixia sales. In the event that we do not obtain any Vatadu stat approvals, you should see the downward trend in operating expenses continue. Research and development expenses were $27.4 million in the third quarter of 2022 compared to $40.5 million in the third quarter of 2021. The decrease compared to prior year period was primarily due to decreased headcount-related costs and the reduction in force, as well as decreased clinical trial costs. Selling, general, and administrative expenses were $30.9 million in the third quarter of 2022 compared to $46.4 million in the third quarter of 2021. The decrease compared to prior year period was primarily due to decreased headcount-related costs as a result in the reduction in force, lower one-time legal costs, and lower marketing expenses. Last quarter, we reported our restructured debt agreement with Pharmacon, which is delivering real savings on the interest expense line. Inclusive of our first principal repayment, our debt outstanding with Pharmacon is approximately $67 million at the end of the quarter. Cash and cash equivalents as of September 30, 2022 were $144.8 million. We believe cash resources will be sufficient to fund our current operating plan for at least the next 12 months. Our operating plan includes assumptions pertaining to revenue growth and cost avoidance measures and the reduction of overhead costs resulting from the plan amendment of contractual agreements with certain supply partners and the reduction of operating expenses. We have not factored in upside related to the potential regulatory approval of Vatadustat or our ability to generate additional value from Vatadustat through partnerships and other transactions. Such potential catalysts could further extend our cash runway. With that, we'll open the line for questions. Operator?

Thank you. At this time, we will conduct a question and answer session. As a reminder, to ask a question, you will need to press star 11 on your telephone and wait for your name to be announced. Please stand by while we compile the Q&A roster. Our first question comes from the line of Allison Ratzel from PSC. Excuse me, from PSC. Forgive me. Your line is open.

Hi, guys. Good afternoon. Thanks for the update and for taking my questions. So the first is on the Arixia business. Now that you're through the restructuring, can you just help us understand the levers and also the timing for reaching cash flow positivity for that asset? And just kind of remind us, what gives you confidence that it will have a significant post-LOE revenue tail And kind of related to that, how do you see the commercial opportunity evolving if binders are added to the bundle? And then I have a follow-up on that.

Great. Okay. Hey, Ali, thanks so much for the questions.

So, you know, Arixia, again, Dave kind of mentioned it. The thing that's really been surprising has been, you know, that the binder market hasn't rebounded, you know, and you look, you listen to, um, you know, the big dialysis providers calls and, um, you know, I've been kind of waiting for the, you know, we were all out of COVID, right. And we're just not in the dialysis population. You look at USRDS data and you see, um, you know, this, this unbelievable 40% mortality rate for dialysis patients. And so, you know, the dialysis community is still dealing with COVID on a regular basis. So that's the wild card here, you know, I mean, Since 1991, or whenever I've been in the business, the binder market's grown every quarter. So, you know, we've got that as a backdrop, and we're not sure when it comes back. You know, but as Dave referenced, you know, the key driver for us, even with that backdrop, is that we have been able to adjust our contracting strategy moving forward, and that's allowed us to, even in a more flat environment, uh sort of uh volume market has allowed us to continue to see growth and we think that will allow us to continue to see growth through uh loe um and so we're not you know and you know as we think about growing the product we're not we're being more cautious about what you can do from a volume perspective just because we don't really know when the market's going to uh to rebound yet we still can drive revenue increases because of the strategy that we've put in place. So, you know, that, you know, that certainly gives us confidence. You know, the post-LOE, we really believe that there's an opportunity beyond exclusivity. Just using Savellumar as a kind of the perfect comp where there was a loss of exclusivity, but for a number of years post, because of the kinds of volumes that generic manufacturers have to produce in the market, there's an opportunity for continued volume growth. Now, it will be a declining revenue, But the way you think of it, people always talk about revenue cliffs after LOE, and we say this is more of a revenue slope, declining slope over time. Now, the other wildcard you referenced is the adding of the binders to the bundle. CMS put out a final rule, again, confirming that there'll be a Tdapa period of at least two years for the binders going into the bundle. That would start in January of 25, and recall LOE is March of 25. So, you know, you have the opportunity to contract directly and, you know, more volume. We have patients who are on free goods now. They all would be part of paying patients. So there are a number of opportunities, still clearly seeing how that's going to play out over the next couple of years. But, you know, we think it's a significant opportunity for us beyond just loss of exclusivity. I think that was that covered. Was there anything else in there? I think I got them all.

I think as Allie said, you know, she was talking about our ability to drive cashflow. I think it really, Allie is just continued operating expense discipline and really focus on what can actually continue to drive the revenue. And again, as John said, the contracting strategy is a big part of it. And from an investment perspective, that's more a, allocation of, you know, the managed markets team time. And so, you know, as we focus the spend, we're aware of where we are in the life cycle, so the spend has reduced over the last couple of years. And we'll continue to do so. Yep.

Excellent. Thanks. And then my second question is on Vatadustat. I guess now that you have the FDA meeting minutes in hand and have submitted the dispute resolution request. It does seem to have a very narrow focus based on what you described today. Could you kind of expand on what gives you confidence that this process could lead to a U.S. approval in a dialysis population? I guess, are there any examples of drugs that have had a successful FDR outcome that you look to as an analog for VADA? And then could you also just walk us through the cadence of updates or milestones that we can expect from the appeal process through the end of the year and then after you receive the response from the agency at your end? Like what comes next? Thanks.

Yeah, thanks for the question. I have to say this is the first time I'm going through a formal dispute resolution myself, so I'm learning as we go as well. But we have great support from folks who have been through it, you know, many times before. And I think each dispute is unique in that the things that you're dealing with are very specific to the CRL, and that's where we're focused. We said from the beginning that the dialysis data, we think, clearly demonstrates that the product can be used safely. I think the concerns that have been expressed in the CRL can be labeled around, and we think being able to to have that conversation in this process will be helpful. As I said, you had the end of review conference that helped narrow the focus for the formal dispute resolution as well. And now it's really focused on those two issues I mentioned, thromboembolic events driven by dialysis access, thrombosis and the potential for DILI, drug induced liver injury. So, you know, it's a very, very focused FDRR. And again, we feel strongly about the data. And, you know, so we certainly won't predict where the FDA will come down, but we're looking forward to going through the process. You know, as we said during the NDA process, you know, we don't kind of, we have constant contact with the agency. So, you know, we don't give kind of play-by-play. So, I think you'll hear when we have a formal response from the agency, which, again, based on the timing, should be by the end of the year. You know, of course, it's the holidays, so that might, you know, leap from a calendar perspective into the first bit of January. But, you know, formally, we expect to hear by the end of the year.

Got it. Thank you. Thanks, Allie. Thanks, Ali. Thank you.

Our next question is from the line of Ed Ark from HCW. Your line is open.

Hello, everyone. This is Thomas Yip asking a couple of questions for Ed. Thank you for the kind of questions. Perhaps the first question, just following up on the FDR process, mentioned in the press release that a response is expected by year end 2022. Can you clarify what type of response should we expect? Would it be a written response or would a future meeting be scheduled at that time?

Yeah, you do expect it to be a formal written response. Not that there won't be lots of or potentially lots of other less formal communication during the process, I think. But once we get a written response, like you get a CRL, you get a response to that formal dispute resolution document. So that's what we expect by the year end.

Got it. Thank you. And perhaps sticking to that, in ARTS, we saw some benefit in the VSAS study What are your initial thoughts on the next study, specifically the primary endpoint or other key endpoints? And also, will this program going forward be partnered with UK Health?

So still working on what the endpoints of the next study will be. I think that the endpoints, you know, the scale that was used in the COVID-19 ARDS study was a very solid endpoint, may well be what we use going forward, but that's still under discussion. You know, I think what's important is that it will be in a broader ARDS population. you know, the COVID population we had in the study that UT performed, and they performed a great study. They executed a great study for us. You know, it was in a younger patient population, a less sick patient population. When you look at, you know, the broader ARDS population, excuse me, driven more by things like pneumonia and sepsis, you see, you know, this much higher mortality rate. And we really think that in that scale, you potentially can see that that treatment effect come through. So, to be determined, we're still working on that, but that's where we think it'll probably go in that direction. So we're looking at performing the study with UT Health. That's not been formally decided either. They did such a great job in the first study, but I wouldn't say the product is partnered with UT Health, but we certainly would look forward to working with them on this next trial.

Okay. Thank you so much for the clarification, and thank you again for the kind of questions. Looking forward to updates on the FDLR.

Thanks, Thomas, as are we. Thank you. I would now like to turn it back to John for closing remarks.

Thanks, Chris, and thank you all again for joining us this afternoon. As I said in the past, a lot has changed for Akibia since April, but I believe we've been thoughtful and deliberate in our efforts to stabilize from a financial standpoint and in our work to plan for the future of Akibia. As we near the close of 2022, we anticipate that we'll have more clarity on regulatory processes and other initiatives that could enable us to potentially add long-term value to the company. We look forward to providing updates as we can. Thanks, everyone.

Thank you for participation in today's conference. This does conclude the program.