Q2 2024 Ardelyx Inc Earnings Call
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I would now like to turn the conference over to Kathleen Lally, Vice President of corporate Communications and Investor Relations at <unk>. Please go ahead.
Thank you good evening.
Speaker Change: Second quarter 2020 financial results call.
Speaker Change: Please refer to the press release issued earlier today.
Speaker Change: On the Investor section of the company's website.
Speaker Change: Uh huh.
Speaker Change: During this call we will be making forward looking statements are subject to risks and uncertainties. Our actual results may differ materially.
Speaker Change: We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q.
Speaker Change: It was filed today and can be found on our website <unk> dot com.
Mike <unk>: We may elect to update these forward looking statements in the future. We typically disclaims any obligation to do so even if our view changed our president and CEO, Mike <unk>, and Chief financial and operations Officer.
Mike <unk>: Ryan will share prepared remarks before we open the call for questions.
Mike <unk>: Now hand, the call over to Mike.
Thank you Caitlin and good afternoon, everyone. It is great to be back together to discuss another quarter of strong performance across all fronts, we continue to drive exceptional progress.
Ryan: Its relative growth momentum continued at a strong pace with another quarter of meaningful gains with revenue growing 25% compared to the first quarter of 2024, and nearly double compared to the second quarter of last year.
Ryan: This performance demonstrates the important role it's relative claim addressing the large unmet need among patients with Ibs C.
Ryan: Every month, we continue to see increases in new and repeat writers as well as new and refill prescriptions healthcare providers see their patients having positive experiences with its rollout and are expanding the number of patients in their practices for whom they prescribed.
Speaker Change: Our market access and affordability program, our <unk> provides a straightforward path for patients to access <unk>.
Speaker Change: It's relevant or important and effective treatment option that is bringing relief to more and more patients who despite previous treatment.
Speaker Change: To experience the debilitating symptoms of Ibs C.
Speaker Change: The potential for its relatively insignificant and reinforces our conviction that it can achieve at least a 10% share of the Ics prescription market as well on the path to becoming a $1 billion product before patent expiry.
Speaker Change: The launch of expose it has been remarkable and makes it abundantly clear that patients have needed a different option to manage their phosphorus when binders are insufficient or not well tolerated.
Speaker Change: For all of US are responding favorably to the benefit exposes providing their patients are increasingly integrating exposing into their therapeutic regimens.
Speaker Change: The consistent feedback from the field is that healthcare practitioners youre seeing in serum phosphorus improvements in their patients. Many for the first time as a result of exposure.
Caitlin Lowie: During this call, we will be making forward-looking statements that are subject to risks and uncertainties. Our actual results may differ materially from those described. We encourage you to review the risk factors in our most recent quarterly report on Form 10-Q, which was filed today and can be found on our website at ardelyx.com. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so, even if our views change.
Speaker Change: These dynamics are translating into significant growth for exposure and only the second full quarter since launch.
Speaker Change: Throughout the development and commercialization of this important therapy, we've demonstrated how vital it is for us to assume the role we have to advocate for the rights of <unk> patients on dialysis.
Speaker Change: As we discussed during our call in July we believe that moving exposed into the Medicare bundled with severely restrict and effectively eliminate access to expose it for all patients.
Speaker Change: To allow patients who are now and may in the future benefit from exposure to no longer have access to the therapy due to a misguided government payment policy is not acceptable.
Speaker Change: We believe that CMS is not acting in the best interest of patients and has instead ignored the countless voices from patient physician provider communities, who are clearly and consistently communicated that oral only phosphate lowering therapies do not belong in the bundle.
Speaker Change: As we have announced in the past months, we have chosen to advocate for patient access to expose across numerous fronts.
Speaker Change: First is the kidney patient act.
Speaker Change: There is significant support for this bill across multiple stakeholder groups and we call on Congress to act and passed with bipartisan buy camera legislation and protect access to all phosphate lowering therapies for all dialysis patients.
Speaker Change: Second.
Speaker Change: We announced in mid July that we filed a lawsuit claiming that CMS is planned to move oral only phosphate lowering therapies, including exposure into the bundle is unlawful and oversteps its statutory and regulatory authority.
Speaker Change: In addition, the complaint argues that the plan is incompatible with Cms's own regulations, stating that renal dialysis services do not include those services that are not essential for the delivery of maintenance dialysis.
Caitlin Lowie: The launch of Xposa has been remarkable and makes it abundantly clear that patients have needed a different option to manage their phosphorus when binders are insufficient or not well tolerated. Nephrologists are responding favorably to the benefit Xposa is providing their patients, who are increasingly integrating Xposa into their therapeutic regimens. The consistent feedback from the field is that healthcare practitioners are seeing serum phosphorus improvements in their patients, many for the first time as a result of EXPOSA.
Speaker Change: We seek relief under the administrative procedure at two enjoying CNS for proceeding with its plan to include expose the in the bundle and thus eliminate coverage for patients under Medicare part D. Beginning in January one 2025.
Speaker Change: We are honored to be joined on this lawsuit by the American Association of kidney patients the nation's largest independent kidney patient organization and the national minority quality form the nation's largest minority healthcare research education and advocacy organization.
Speaker Change: There are partnership demonstrates just how significant of an impact. This policy will have on patients and how critical is that we protect patient choice and timely access to phosphate lowering therapies.
Caitlin Lowie: Throughout the development and commercialization of this important therapy, we've demonstrated how vital it is for us to assume the role we have to advocate for the rights of CKD patients on dialysis. We believe that CMS is not acting in the best interest of patients and has instead ignored the countless voices from patient, physician, and provider communities who have clearly and consistently communicated that oral-only phosphate lowering therapies do not belong in the bundle.
Speaker Change: We are still early in the process and cannot share details regarding our expectations or timing or success.
Speaker Change: At this point, we await confirmation that a government lawyer has been assigned to the case and then we will be able to commence discussions regarding the timeline.
Speaker Change: We are hopeful that there can be some action before the end of the year on the case.
Speaker Change: Third.
With our decision not to apply for to that but we believe that we are able to continue making progress on our strategy to maximize patient access to exposure.
Speaker Change: As we learn more and make decisions, we're committed to communicating to you as comprehensively as possible.
Speaker Change: I hope that what you can take away from our past actions and from our approach is that we will exhaust all options available to us to protect patient access to expose it and to protect our business.
Caitlin Lowie: The first is the Kidney Patient Pack. There is significant support for this bill across multiple stakeholder groups, and we call on Congress to act and pass this bipartisan, bicameral legislation and protect access to all phosphate-lowering therapies for all dialysis patients. We seek relief under the Administrative Procedure Act to enjoin CMS from proceeding with its plan to include exposure in the bundle and thus eliminate coverage for patients under Medicare Part D beginning January 1st, 2025.
Speaker Change: What should be clear from my remarks, and from Justin's to come is that our business is growing and our performance during the second quarter demonstrates the strong fundamentals driving this growth.
Justin: Delivering on our priorities executing our disruptive commercial and market access approach and remaining committed to the <unk> mission of putting patients first.
Justin: Our two first in class medicines are bringing meaningful benefits to patients we are well capitalized and we are focused on our future. Both in terms of our current products as well as pipeline expansion.
Justin: I will now turn the call to Justin who will walk through the details of our financial performance Justin.
Justin: Thank you Mike I'm very pleased to be with you to discuss the second quarter performance. We reported earlier today, which included significant growth for both of our commercial products.
Speaker Change: Full management of our finances, while maintaining a strong balance sheet.
Justin: Let's start with revenue.
Justin: We reported significant year over year revenue growth during the second quarter totaling $73 2 million.
That is compared to $22 3 million in total revenue during the same period in 2023.
Justin: This growth reflects incredibly strong performances from both ROA, and <unk>, which together totaled $72 6 million and.
Justin: Net product sales revenue in the second quarter of 2024 compared to $18 3 million net product sales revenue coming from abroad.
Justin: Quarter of 2023.
Justin: Before I jump in I would like to take a moment to share our perspective on the publicly available prescription data trends relative exposure as many of you and Kevin best considered those data in relation to our revenue.
Justin: First as you know our net sales revenue is based upon bottle shipments to our distributors and is not directly linked to prescription level data available from symphony or Ikea.
Justin: As we've discussed our distributors and pharmacies keep limited amount of product in the channel essentially just in time inventory management.
Caitlin Lowie: I hope that what you can take away from our past actions and from our approach is that we will exhaust all options available to us to protect patient access to EXPOSA and to protect our business. What should be clear from my remarks and from Justin's to come is that our business is growing, and our performance during the second quarter demonstrates the strong fundamentals driving this growth. Our two first-in-class medicines are bringing meaningful benefits to patients.
Justin: I encourage you to use some caution as information from prescription data providers can be incomplete and inconsistent.
Justin: Especially for medicines like and thrown exposure as a result of our market access and distribution strategy that relies on our critical relationship between Hcp's specialty pharmacies in our Dallas facility.
Justin: Remember too that not all prescriptions are a 30 day supply somewhere 60 day and summer 90 day supply.
Speaker Change: We understand the desire to use those data we want you to consider these dynamics moving forward.
Speaker Change: With its realm, we began providing with revenue guidance and we're comfortable we were able to provide a solid expectation of the future performance of the product.
Caitlin Lowie: We are well capitalized, and we are focused on our future, both in terms of our current products as well as pipeline expansion. We reported significant year-over-year revenue growth during the second quarter, totaling $73.2 million. That is compared to $22.3 million in total revenue during the same period in 2023.
Speaker Change: We will provide similar guidance for expose them when we have a solid perspective of our future expectations.
Speaker Change: For the second quarter of 2024 net product sales revenue was $35 4 million.
Speaker Change: Nearly doubling the $18 $3 million in revenue, we reported during the same period last year, and 25% quarter over quarter growth compared to the first quarter of 2024.
Speaker Change: <unk> performance was due to strong volume growth, resulting from demand driven by our commercial focus and increased depth and breadth of writing.
Speaker Change: That focus continues to translate into growth in new and refill prescriptions as well as expansion of new and repeat rates.
Speaker Change: We also benefited from the expected improvement in our gross to net deduction further broiler, which decreased from 33, 5% in the first quarter. This year to 29, 7% in the second quarter.
Speaker Change: As we've seen over the past two years, we expect to gradually improve over the remainder of the year.
Speaker Change: We are in the final stages of completing the expansion of the thrill of sales team.
Speaker Change: Ibs C market has responded very favorably to throw our product and clinical profile and our marketing efforts it.
Speaker Change: It is also clear that increasing exposure and frequency of messaging to our target healthcare providers generates new writers and expand the number of patients treated by existing reps.
Caitlin Lowie: First, as you know, our net sales revenue is based upon bottle shipments to our distributors and is not directly linked to prescription-level data available from Symphony or IQT. I encourage you to use some caution as information from prescription data providers can be incomplete and inconsistent. We will provide similar guidance to you for EXPOSA when we have a solid perspective of our future expectations. IBSC Market has responded very favorably to the Azrela product and clinical profile and our marketing efforts.
Speaker Change: We expect the expanded sales team to begin having an impact weight in this quarter.
Speaker Change: As we consider the second half of the year the fundamentals driving its growth performance remained weak.
<unk> continued strong quarter over quarter growth for the remainder of this year and we reiterate our guidance.
Speaker Change: We expect full year 2020, Forbes rollout U S. Net product sales revenue will be between 140 $150 million.
Speaker Change: Now turning to exposure.
Speaker Change: <unk> continues its exceptional performance reporting $37 $1 million in second quarter net product sales revenue up from $15 2 million, we reported in the first quarter of the year.
Speaker Change: Growth continues to be driven by strong demand from health care providers, who have a clear need for a new and different options for dialysis patients to help them achieve targeted phosphorus levels.
Speaker Change: In addition to the strong demand for exposure our gross to net deduction improved from 23, 8% in the first quarter to 21, 4% for the second quarter period.
Speaker Change: As is the case goods railroad the primary deductions reflected in our gross to net for exposure on a standard fees to our distributors.
Speaker Change: The maintenance discount with the government payers.
Speaker Change: And costs associated with our commercial co pay program and consistent with our distribution and market access strategy, we do not contract to provide rebates to payers and pharmacy benefit managers.
Speaker Change: Commercial patients we have an out of pocket co pay cost may have their co pay requirements.
Speaker Change: Thus the impact on our gross to net is highly dependent on our payer mix and utilization of our commercial co pay program.
Speaker Change: We're very pleased with these results to date.
Speaker Change: As we continue to learn more about the patient and payer mix that impacts the calculation, we will provide our expectations for the growth in production as we do with a thriller.
Speaker Change: We are very pleased with our top line results during the quarter.
Speaker Change: Our commercial approach is working and our teams are executing at the highest level to build and maintain the growth momentum we've established both a thriller Expo.
Speaker Change: Now for the extended the cash side.
Speaker Change: Throughout the second quarter, we continue to be thoughtful in how we manage our expenses.
Speaker Change: Research and development expenses were $12 8 million.
Compared to $8 3 million during the second quarter of 2023. This increase reflected expanded field based medical affairs teams focused on the gastroenterology and nephrology community.
Speaker Change: Selling general and administrative expenses were $64 7 million for the second quarter compared to $27 2 million for the same period of 2023.
Speaker Change: The increase related to commercial launch activities for disposal investments the growth relative were out last year as well as extensive as well as sales came in at just spoke to and which occurred primarily during the second quarter of this year.
Caitlin Lowie: Those exchanges had exceptional performance, reporting $37.1 million in second quarter net product sales revenue, up from $15.2 million we reported in the first quarter of the year. Growth continues to be driven by strong demand from health care providers who have a clear need for a new and different option for dialysis patients to help them achieve target phosphorus levels, and costs associated with our commercial co-pay program. And consistent with our distribution and market access strategy, we do not contract to provide rebates to payers or pharmacy benefit managers.
Speaker Change: We have previously communicated we expect our SG&A run rate once the expansion is complete be approximately $80 million per quarter.
Speaker Change: Substantial top line growth combined with thoughtful cost management resulted in a net loss of approximately $16 5 million or <unk> <unk> per share compared to a net loss of $17 1 million or <unk> <unk> per share in the same period of 2023.
Our $16 $5 million net loss for the second quarter of 2024 included $12 3 million in combined noncash expenses for share based compensation and noncash interest expense related to the sale of future royalties.
Speaker Change: We finished the second quarter and a strong cash position.
Speaker Change: As of June 32024, we had total cash cash equivalents and short term investments of $186 million.
Speaker Change: As compared to $184 3 million at the end of 2023.
Speaker Change: We did not engage in any fund raising activities. During Q2. However, as a reminder, we drove a $50 million tranche C from our debt agreement with SLR capital back in March.
Justin Renz: As we continue to learn more about the patient and payer mix that impacts the calculation, we will provide our expectations for the growth set deduction as we do with the throw. We are pleased with our performance during the second quarter, driving continued and substantial top-line growth across our product lines, managing our operating expenses, and maintaining a strong balance. Thanks, Justin. Q2 was a remarkable quarter. We demonstrated significant growth for both our products, and we shared our perspectives on the impact of oral-only drugs entering the Medicare bundle and our commitment and plans to fight for patients. To ask a question, you may press star then 1 on your telephone keypad.
Speaker Change: We are pleased with our performance during the second quarter driving continued and substantial top line growth across our partner product lines, managing our operating expenses and maintaining a strong balance sheet we.
Speaker Change: We will continue to be thoughtful with how we deploy capital while focusing on maximizing shareholder value.
Speaker Change: With that I'll hand, it back to Mike.
Mike <unk>: Thanks, Justin Q2 was a remarkable quarter, we demonstrated significant growth from both our products and we shared our perspectives on the impact of oral only drugs entering in Medicare bundle and our commitment and plans to fight for patients.
Speaker Change: Considering all options and making progress yet we still have a lot of work to do we do not fight alone.
Speaker Change: I would like to extend my sincere thanks to our many partners physicians patients and advocates as well as all of <unk> for lending their voices to the important work. We have ahead of us to protect patient access to expose.
Speaker Change: The past few weeks have demonstrated just how aligned we all are and supporting patients and making sure that they have access to innovative therapies.
Speaker Change: We have the team in place to deliver and we will continue to update you as developments occur and progress is made.
Speaker Change: We appreciate your support as we move through the next few months I will now open the call to questions operator.
Speaker Change: Thank you we will now begin the question and answer session.
Speaker Change: To ask a question Star then one on your telephone keypad.
Speaker Change: If you were using our hands if youre using a speakerphone. Please pick up your handset before appropriately keys.
Speaker Change: Definitely time. Your question has been addressed we would like to withdraw your question. Please press Star then two.
Speaker Change: Today's first question comes from Louise Chen with Cantor. Please go ahead.
Louise Chen: Hi, congratulations on the quarter and thank you for taking my question. So first question I had for you with on X.
Speaker Change: Those are very strong and you mentioned something from a gross to net perspective that sounded like it may create some volatility quarter to quarter. So just curious how you think we should model or think about forecasting the product going forward and just wanted to confirm it sounded like there was not any inventory build.
Speaker Change: I just wanted to confirm that there wasn't anything like that thank you.
Speaker Change: Hey, Larry Thanks for the question.
Speaker Change: Yes.
Speaker Change: Justin will go into some detail on it but I think really what we're trying to communicate there is as we did with its rolla, giving specifics on guidance as premature at this stage of our exposure.
Justin: We are learning the ins and outs of what's happening.
Justin: Justin if you can provide some perspective too.
Justin: Sure. Thanks, Yes, we'll continue to have low amounts of inventory in the channel and Thats been very consistent.
Throughout the course of actually both product launches and from a gross to net perspective, the largest variable is in our commercial co pay program and so theres been some mild fluctuation of course.
Speaker Change: <unk> suggested that are sensitive to the payer mix. So we continue to learn more and more about how that goes.
Speaker Change: But we're pleased with what we've seen so far.
Speaker Change: And maybe if I could just ask one more question here with curious with respect to expose that and your initiatives to keep it out of the CMS bundle I know you've seen CMS, what other initiatives could you take to fulfill what youre trying it there. Thank you.
Speaker Change: Well I think thats the.
Speaker Change: The work that we're doing still ongoing so it's premature to go into any of that and there is a lot of work going on behind the scenes.
Speaker Change: As you've seen Louise we will exhaust all options to make sure that patients continue to have access to these drugs.
Speaker Change: Hey, thanks.
Speaker Change: Thank you and our next question today comes from resolved from Citi. Please go ahead.
resolved: Yes, hi, thank you very much.
Speaker Change: Just a quick follow on the inventory question is it possible that you could provide any quantification.
Speaker Change: The low inventory looks like for both products and then on the on the SG&A you mentioned, Justin I think $80 million run rate per quarter.
Speaker Change: Comment on when you would get to that to that point. Thanks.
Unnamed Analyst: Hi, congratulations on the quarter and thank you for taking my question. So, the first question I had for you was about Xposa. Obviously, the sales were very strong, and you mentioned something from a growth to net perspective that sounded like it may create some volatility quarter to quarter. So, just curious how we should model or think about forecasting the product going forward, and just wanted to confirm. It sounded like there were not any inventory bills, but I just wanted to confirm that there wasn't anything like that.
Speaker Change: Yes, Justin.
Justin: Sure. So on the ladder. So SG&A was $64 7 million in the second quarter, which reports include noncash stock compensation expense and we can do to add to the sales force. So we expect to get tour as we build the sales force are almost done with the <unk>.
Justin: Ramp up of bps relative team, we should hit that $80 million level in the fourth quarter of this year.
Justin: In terms of inventory in the channel both products have been very consistently low we have a very.
Justin: Distribution channel and so there is obviously some variability.
Speaker Change: On a specialty pharmacy and specialty pharmacy basis, but in general we have been.
Speaker Change: In that one five to two and a half maximum we're closer to two weeks tops in the channel on a regular basis.
Speaker Change: Okay. Thank you very much.
Speaker Change: Thank you and our next question today comes from Dennis Staring with Jefferies. Please go ahead.
Dennis Staring: Hi, Thanks for taking my questions and congrats on a really strong second quarter. So I had a question on <unk> you guys. Obviously, expanding your sales force since earlier this year just wondering how much of second quarter's performance.
Speaker Change: Some of these new sales reps and so we expect an inflection in the second half as you complete some of these new hires and maybe even comment on when you expect those new hires too.
Speaker Change: Two to be higher and then as a follow up just on R&D. I mean, we appreciate you guys have two very successful commercial franchises, but lumpiness, if I recap grooming clusters.
Speaker Change: So <unk> patents to expire in early 2000 <unk>.
Speaker Change: How do you guys think about the pipeline so where does this on your list of priorities. How soon can we hear more about that thank you.
Speaker Change: And then thank you for the question.
Speaker Change: Turning to sales force expansion I think.
Unnamed Analyst: Yeah, hi. Thank you very much. Just as we can follow on the inventory question, is it possible that you could provide any quantification of what the low inventory looks like for both products? And then on the SG&A, you mentioned Justin, I think 80 million run rate per quarter.
Speaker Change: Justin's comments, you heard that we expect that the full expansion will begin having impact.
Speaker Change: By the end of this month.
Justin: It was it's a process to hire 60, new people. They don't all come on of once you get to train and certify.
So the full team is not on board until the end of this quarter. So we expect that.
Ryan Deschner: Just can you comment on when you would get to that? Yeah, Justin, some of these new hires and maybe even comment on when you expect those new hires. Hey, Ryan, thanks for the question. It's an interesting question because, you know, you would think that patients in control deserve the opportunity for something like EXPOSA, too. I can say that, you know, not many stories yet that are coming that way, as I think the enthusiasm and excitement that we see is, you know, don't forget that, Hi, thanks for taking my questions.
Justin: As we said, we're reiterating our $1 40 to $1 50, Dennis you know as <unk>.
Speaker Change: Well by now that we're not going to get over our skis, we're thrilled with the performance.
Dennis Staring: But I think what you can count on is the reiteration of the guidance that we've given in terms of R&D I think as we've discussed before one of the reasons that.
Dennis Staring: We've brought in.
Speaker Change: My color her onboard as our executive Vice President of strategy and corporate development was to address exactly the question that you have.
Speaker Change: Have brought up is looking for those programs that we could bring insight into in house that are complementary to what we have created with both explore zone as rolla as.
Speaker Change: We made progress on those things certainly that's.
Speaker Change: What we will bring to the fore and share with everyone.
Speaker Change: Great. Thank you.
Dennis Staring: Thanks Dennis.
Dennis Staring: Thank you and our next question comes from Laura Chico of Wedbush. Please go ahead.
Laura Chico: Good afternoon, and thanks very much for taking the question I guess just two here one on <unk> congrats on the progress.
Laura Chico: Can you talk a little bit about what's necessary to see pull forward in earlier lines of utilization and with respect to your prior peak estimates here can you remind me how much the earlier utilization play into your assumptions and then I think I missed it but expose that what was the split on Medicare versus non Medicare. Thank you.
Speaker Change: Yes. So we didn't go to the latter question first we didn't provide that split.
Speaker Change: I think implied in adjustments comments about gross to net those are things that we're going to see evolving over time. So I think we've talked historically about a 45 to 55 split non Medicare to Medicare.
As an example in terms of Israel EBIT.
EBIT specificity as to I think what youre asking about <unk>.
Previous utilization pulling forward as refill prescriptions right of that we've not talked about that and I think still it's something that we're looking to understand and not not sharing at this stage.
Speaker Change: But it's both right, it's new patients as well as refills is physicians that are.
Speaker Change: Our incredible team on the ground is convinced to try and then that they are expanding their utilization across the broader patient population.
Speaker Change: The grit and grind.
Speaker Change: That this team does and that was what drove much of the decision around the expansion that we expect to see the impact of by the end of this month.
Speaker Change: Thanks, very much guys.
Lauren: Thanks Lauren.
Lauren: And our next question today comes from Roanna Ruiz with Leerink partners. Please go ahead.
Roanna Ruiz: Hi afternoon, everyone.
Roanna Ruiz: So a question on exposure I was curious what.
Speaker Change: Current field force strategies are getting the most traction so far with physicians in the first couple of quarters of this year and if you can elaborate its volume coming more from possibly new and repeat prescribers, so far and how that affects your convection going into the second half of this year with excellence.
Speaker Change: Hi, Ryan Thanks for the question. So we're two quarters in so it's kind of tough to think about repeat writers yet.
Speaker Change: <unk>.
Speaker Change: I think is probably not inconsistent with other launches physicians are going to be trying.
Speaker Change: Drugs on their hardest to treat patients and the fact that you then see expansion within that physician to other patient southern it's working in those patients and those patients who may be less challenging or having a.
Speaker Change: Let's have a difficult time, managing their serum phosphorous deserve the opportunity to have a product like exposure, helping them manage their phosphorous levels. So it's across the board.
Speaker Change: And thats the enthusiasm that we are on that.
Anecdotally, we hear these stories about patients who for the first time ever are able to get their serum phosphorus and control that's.
Speaker Change: That's meaningful right when you've only had binders your entire career through your training as a nephrologist and then you have a new mechanism like expose as an opportunity to help their patients get the bowl youre going to try it and if it works as this does youre going to expand its use.
Speaker Change: Got it makes sense.
Ryan <unk>: Thank you and our next question today comes from Ryan <unk> with Raymond James. Please go ahead.
Ryan <unk>: Are there first off congratulations on the impressive quarter.
Ryan <unk>: <unk>.
Ryan <unk>: Two quick questions for me at this point are you getting any feedback from prescribers, suggesting there is uptick in patients with adequately controlled serum phosphorus and number two regarding your litigation with CMS, what would the timeline for securing access to expose up for Medicare patients look like and sort of the best case scenario here. Thanks.
Speaker Change: Okay, Ron Thanks for the question.
Speaker Change: It's an interesting question because you would think that patients in control deserve the opportunity for something like expose it to.
Speaker Change: I can say that not many stories that are coming that way.
Speaker Change: I think the enthusiasm and excitement that we see is don't forget that.
Speaker Change: So almost 70 almost 80% of these patients over time and the six month period of time are out of control. So one might say and control today, but historically not.
Speaker Change: They deserve the opportunity as well.
Speaker Change: So I think it's all over different kinds of profile. So.
Speaker Change: The most important thing is the and what we're hearing is very strong results in terms of patients getting to goal.
Speaker Change: I think from the comments that we made it's premature for us to be providing any commentary in terms of where the status of the lawsuit scans.
Speaker Change: We are committed as we learn more in terms of the timeline and the discussions that we will have with the government lawyers that we will share that.
Speaker Change: Thank you very much.
Ryan <unk>: Thanks Ryan.
Speaker Change: And our next question comes from Joseph Thome with Cowen. Please go ahead.
Joseph Thome: Hi, there good morning, and thank you for taking my questions. Congrats on the quarter, maybe just two from me to follow on a little bit on a prior question can you talk a little bit to the breadth of prescribers that youre seeing for exposed.
Speaker Change: Versus maybe your overall target prescribers.
Prescriber account base and then second just to get a little bit of understanding I guess, if the bundle does go through and we don't really hear by the end of the year that that will be extended I.
Speaker Change: I guess, what sort of happens to Medicare patients that are currently on expose their grace period or.
Does that hit January 1st and we have to figure out how to get medicines to patients or not thank you.
Speaker Change: Sure. Thanks for the question Joe.
Speaker Change: So in terms of the breadth of prescribing again, we're two quarters into this launch.
Speaker Change: And we've got <unk>.
Speaker Change: Our incredible field force of 60, ABB is making those calls, but I can say is that.
Speaker Change: The interest on the part of all of those physicians that were had been able to see clearly as demonstrated by the revenue that we announced today.
Speaker Change: So I think we continue on the path that that shows that these patients truly deserve.
Speaker Change: The access that we're fighting for it for them to your question about Medicare if things move forward, we have an important continuity of care program.
Speaker Change: That exists for patients so that it can be something that.
Speaker Change: If we need to patients are going to be able to access.
Speaker Change: Our hope is honestly with everything we're doing in our continued.
Speaker Change: Evaluation of other things that we might do is that we don't come to a place where patients who deserve access to a drug like this.
Speaker Change: Prevented or prevent to do so because of <unk>.
Speaker Change: Misunderstanding or unlawful perspective at CMS has about what we're trying to fight against.
Speaker Change: Because they are just going to ultimately effectively ensure that patients don't get this drug that's working if they continue on the path that they're on.
Speaker Change: Alright, thank you.
Joe: Thanks, Joe.
Joe: And our next question today comes from Ed Arce with H C. Wainwright. Please go ahead.
Speaker Change: Alright, Thanks for taking my questions and let me add my congrats on a truly remarkable quarter.
Ed Arce: Quarter of growth here.
Ed Arce: First question is on exposure.
Speaker Change: 145% quarterly growth sequential.
Speaker Change: And already surpassing of drilling in the second full quarter.
Speaker Change: Wanted to ask about the.
Speaker Change: What's driving that obviously you've mentioned.
<unk> strong demand and the focus on difficult to treat patients, but wanted to ask if there is.
Speaker Change: Other areas.
Speaker Change: That you've discussed with physicians.
Speaker Change: That group.
Speaker Change: Sure, but more light on this and if there.
Speaker Change: Has been any discussion of where.
Speaker Change: <unk> may not be appropriate for any of their patients.
Speaker Change: And then I have a couple of follow ups.
Speaker Change: Sure so.
Speaker Change: Remember that we started educating the nephrology community about this new mechanism.
Speaker Change: Opportunity to expose as disease awareness before what was supposed to be the approval in 2021.
Speaker Change: We had the terrible surprise that was given to us by the FDA and resulted in the CRM. So there was a lot of disease awareness product awareness before that occurred and hence the fight that we started that everyone's aware of through the FTR process two years plus later with its launch.
Speaker Change: So disease awareness expose awareness was significant that certainly plays a role.
Speaker Change: But most importantly is the clear unmet need.
Speaker Change: The requirements that have to be there for patients to get to goal and the fact that this drug is helping accomplished just that.
Speaker Change: That's a big.
Speaker Change: Massive part of what as we establish sort of market for the for the opportunity, but it's also the field force we have a group of remarkable abb's exposure side as we do with the trailer who are doing the work required to help physicians understand and option for both of these <unk>.
Speaker Change: Vacations, where there hasnt been another mechanism with the kind of clinical benefit that both of these drugs are providing I think that's what's driving and is driving as it should.
Ryan Deschner: And let me add my congratulations on a truly remarkable quarter of growth here. Um, and then I have a couple. Okay, and last question is, you know, just wondering if you could explain a little bit further some of your contingency plans if it comes to pass that your efforts with CMS on the oral phosphate agent, Got it. Very helpful. Thank you. Thanks, Ed.
Speaker Change: What youre seeing in this quarter's performance.
Speaker Change: In terms of places, where you wouldn't use it there really arent any comments that we're hearing from that remember our label is for those patients where there is an insufficient response or are intolerant ability to binders, which where the statistics as we all know.
Speaker Change: Insufficient is.
Speaker Change: A large majority of these patients over any six month period of time or less.
Speaker Change: They are paid.
Speaker Change: Patients who can.
Speaker Change: Access to this product.
Speaker Change: So I think our label clinical benefit the evidence that physicians are seeing in their own practices.
Speaker Change: As well as the commercial approach that we're taking I think is resulting in what you're saying.
Speaker Change: Great.
Speaker Change: Are you aware of any physicians.
Speaker Change: Sure.
Speaker Change: Experiment with this drug as a monotherapy.
Speaker Change: Well remember that the label says insufficient or inadequate and holiday then use that whether it is on top of a fixed dose of binder, whether as a decrease in binder dose with exposure on top of that or an element.
Speaker Change: Nation of Binder, because it is not working and exposure as monotherapy is all within the indication on our label and all of those are approaches that physicians are taking.
Speaker Change: Okay.
Speaker Change: Last question is.
Speaker Change: Just.
Wondering if you could explain a little bit further some of your contingency plans if.
Speaker Change: That comes to pass that your efforts with CMS on the oral phosphate agents.
Speaker Change: Our unsuccessful and Theyre moved into the bundle.
Yes.
Speaker Change: I appreciate the question.
Speaker Change: Absolutely and.
Speaker Change: Would love to be able to be in a position.
Speaker Change: To provide you clarity on that its just not its premature at this stage bits of work that's ongoing I think the progress that we've made I feel very very good about.
But.
You know us well by now that we're not going to get over our skis.
Speaker Change: And communicate something that we arent fully 100% comfortable with so.
We believe that there are opportunities.
Speaker Change #100: God forbid that what you just described that occurs.
Speaker Change #100: But it's premature for us to provide those details.
Speaker Change #101: Got it very helpful. Thank you. Thanks.
Ed Arce: Thanks, Ed.
Speaker Change #102: Thank you and our next question today comes from Matt Kaplan Ladenburg Thalmann. Please go ahead.
Matt Kaplan: Hey, guys. Thanks for taking my questions and congrats on the very strong quarterly results.
Matt Kaplan: A follow up to Ed's question, a little bit in terms of <unk>.
Matt Kaplan: Maybe it's with the understanding it's early in our launch but help us understand in terms of the breakdown of patients.
Speaker Change #104: On the drug or is it mostly being used in the combination setting or.
Speaker Change #105: To Ed's question now monotherapy in patients who are intolerant.
Speaker Change #104: Yeah.
Speaker Change #105: Of the binders.
Speaker Change #104: So.
Speaker Change #107: Specific breakdown across those patients right, you're going to get anecdotes right I'm not going to.
Speaker Change #107: When a prescription is filled for exposure it doesn't say on top of.
Speaker Change #107: Binder on top of half Binder of monotherapy you just got.
Speaker Change #107: Stripping for exposure. So all I can provide at all I can say anecdotally.
Speaker Change #109: Distribution of all of those patients what that then results in.
Speaker Change #107: What it looks like for all of the patients I don't I can't tell you that.
Okay fair enough.
Speaker Change #109: And then any update on the hearings we spoke recently.
Speaker Change #109: But in terms of the status of the kidney care Act.
Speaker Change #109: Where that is.
Speaker Change #110: Yes, I mean, we continue to make incredible progress you saw.
Speaker Change #111: As we do.
Speaker Change #111: Two new co sponsors are have joined on the house side.
Speaker Change #111: And the fact that we have as I said in my opening opening comments both.
Speaker Change #111: Bipartisan bicameral support with the Senate companion Bill.
Speaker Change #111: Is incredibly strong for us and it's going to ultimately come down to how bills are passed which we all know and.
Speaker Change #111: End up being an omnibus or mini buses at the end of the year when others healthcare legislation that it can ride on all of those things that we talked about in the past.
Speaker Change #111: What is clear is all of the constituents that have worked on this and continue to work on it.
Speaker Change #111: Are demonstrating why this is absolutely the right thing for Congress to do while in parallel we continue all of the other approaches from both the legal side as well as the evaluation that we are undertaking to look at what else. We can do after the decision that we made to not file bridge DARPA.
Speaker Change #111: So I think as we described in our last discussion on this in July it's kind of like a three dimensional chess game.
Speaker Change #111: Where we're looking at moving all these pieces and trying to make sure that.
Speaker Change #111: That we are doing all possible to ensure access for patients.
Speaker Change #113: Right Okay.
Speaker Change #111: Hi.
Pat: Thanks Pat.
Speaker Change #115: Thank you. This concludes our question and answer session.
Speaker Change #115: Now I'd like to turn the conference back over to President and CEO, Mike Raab for any closing remarks.
Mike Raab: Thank you everyone for joining us this evening.
Mike Raab: As Im sure you understand we will remain focused on our priorities and we will provide information updates when we can in the meantime, we remained steadfast in our commitment to patients and to maintaining our commercial momentum with that we can close the call.
Ryan Deschner: You only get anecdotes, right? I'm not gonna, when a prescription is filled for exposure, it doesn't say on top of that. And then any updates that you're hearing, as we spoke recently, but in terms of the status of the Kidney Care Act and where that is. Thanks, Bill. The Ultimate Parody Site! BF-WATCH TV 2021
Mike Raab: Operator.
Operator: Thank you Sir This concludes today's conference call.
Speaker Change #118: Thank you all for attending today's presentation.
Speaker Change #119: Now disconnect your lines and have a wonderful evening.