Ardelyx, Inc. 12th Annual Cantor Fitzgerald Global Healthcare Conference
Review the key takeaways and the transcript of this earnings call.
- Ardelyx reported strong growth for Abzrella, with 73% growth in 2023 to $274 million and guidance for roughly 50% growth in 2024.
- The company is on the cusp of profitability, which it expects to achieve in 2027.
- Abzrella faced payer hurdles including step edits and prior authorization requirements, leading Ardelyx to double its field reimbursement managers to 40 and promote use of its specialty pharmacy network, the Abzrella Pharmacy Network, to improve prescription fulfillment.
- Exposa contributed positively with paid prescriptions growing 25% in Q2 2024 and guidance maintained at $110 to $120 million for the year.
- Ardelyx reiterated its long-term $1 billion sales target for Abzrella but extended the timeline due to a lower compound annual growth rate in 2024 guidance.
- The company highlighted the difficulty for generics to enter the Abzrella market due to complex manufacturing and clinical trial requirements, with patent protection extending to 2042 plus pediatric exclusivity.
- Ardelyx is advancing a phase 3 trial for Abzrella in chronic idiopathic constipation (CIC) with data expected next year, aiming to expand label and reduce payer friction.
- The company has a preclinical next-generation NH3 inhibitor that is more potent and soluble, with development decisions guided by ongoing science.
- Ardelyx ended June 2024 with $282 million in cash and is actively exploring business development opportunities in GI, renal, and cardiology areas, focusing on early-stage assets.
- The company expects operating expenses to level off in 2025 while top-line growth accelerates, supporting its path to profitability.
- Management emphasized the strength of its intellectual property and cash generation as key competitive advantages.
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Transcript
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All right. Welcome, everyone, to day two of Cantor's Global Healthcare Conference. My name is Prakhar Agrawal. I'm a biotech analyst at Cantor, and for the next session, we have the pleasure of hosting the Ardelyx team. From Ardelyx, we have Mike Raab, CEO, and Sue, CFO. Thank you for joining us today.
Thank you. Thank you. Maybe we can start off with an overview of the key priorities for the company over the next one to two years and take it from there.
Sure. Prakhar, thank you, and thank you for Cantor for inviting us. We are at an important juncture for the company. If you look at our guide for IBSRELA this year and XPHOZAH, it gets us to a place where we are on the cusp of profitability, which we have guided to in 2027. The business has continued to grow, contribute, and provide the benefit that we have always expected out of both of these indications, and excited for what we will accomplish this year as we enter 2027.
Sue, anything? Yeah, the one thing I would like to talk to is, with our company, we have put out our capital allocation priorities because, as Mike said, we are on the verge of profitability, so we want to make sure everybody is clear on where we are going to spend that money.
When you think about our currently marketed products, IBSRELA and XPHOZAH, spending money behind them and really trying to ensure that we continue to grow. Also importantly, our pipeline, so both our internal assets that we have announced are preclinical and are phase III, as well as pediatric trials, and then opportunistic M&A. And then finally, just the work we do around the financial discipline, whether it is refinancing and just doing the right uses with all the cash that we have.
Okay. Okay. Maybe we can touch on this IBSRELA first.
Sure. I guess coming out of 2Q, there were a lot of puts and takes.
Maybe just at a high level, provide your perspective on what happened.
Sure. Well, the simple answer is we got noticed. I think the success that we've seen with IBSRELA, where we grew 73% plus, 2025 over 2024, $274 million that we generated last year, moving into the guidance that we had of roughly 50% growth this year. The attention was being paid by the payers. As we saw dynamics beginning to change a bit in retrospect in Q4, we recognized the hurdles that payers were putting in place for our patients as they went through from the top of the funnel to ultimately getting a prescription fulfilled.
When we changed our guide during the second quarter earnings, it was based upon those frictions that we were seeing and the beginning of conversations that we're having with the payers to do what we can to lessen the burden of what both the patients and the healthcare practitioners have to go through in order to get a prescription filled.
Okay. I guess what specific steps these payers were taking in terms of step edits or prior authorization, and what are you doing right now to mitigate some of these?
Sure. Yeah, I think it's both.
We have seen step edits a lot of times going from LINZESS and having to then go back onto a generic lubiprostone, was one thing that we saw. Then also instead of a prior authorization, more of an easy access to a checkbox, it was, let's see your chart notes, and things like that. We heard that from the physician offices through our reps and everything else. Certainly being able to hear that then gives us the opportunity to act. That's what we're doing right now to help alleviate that as we go forward.
One of the things that we had actually started last year, which is helping with this, is the doubling of our field reimbursement managers. If you think about the journey that patients go through, I go to you as my physician saying with all my complaints, you say I have IBS-C. You prescribe IBSRELA for me, and that's the top of the funnel. Then ultimately the step edits, the pressures on prior authorizations that go through will determine how many actually come through the bottom. So we had doubled the number of people in the field helping with field reimbursement efforts to educate the offices on what it actually takes, and then other support that we have to help facilitate that. A really important one is the attempt to move, and we will over time, the prescriptions to go through our specialty pharmacy network called the IBSRELA Pharmacy Network.
Because what we know with that higher touch, the better understanding of the processes that one has to go through for a prior authorization, that that will result in the greater likelihood of a script getting filled faster. Then for refills, on average, you're going to see one or two additional scripts that come from patients through that IBSRELA Pharmacy Network. So it is a very good thing to do. But changing the habits of the prescribers to take those prescriptions through the IPN is a big part of the work that we're doing now as well.
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