Ardelyx Q2 2023 Earnings Call Transcript

Quartr
Provided by Quartr
August 2, 2023

There are 10 speakers on the call.

Operator

Hello, and welcome to the Arlec Second Quarter 2023 Conference Call. All participants will be in listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note, This event is being recorded. I now would like to turn the conference over to Caitlin Lauy.

Operator

Please go ahead, ma'am.

Speaker 1

Thank you. Good morning, and welcome to our Q2 financial results call. During this call, we will refer to the press release issued earlier today, which is available on the Investors section of the 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 our risk factors in our most recent quarterly report on Form 10Q It was filed today and can be found on our website atardellix.com.

Speaker 1

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. Our President and CEO, Mike Raab, will begin today's call with opening remarks and an overview of the company's progress During the Q2 of 2023. Next, Susan Rodriguez, Chief Commercial Officer, will provide an update on the launch of Estrella. Justin Rooms, Chief Financial and Operations Officer, will conclude today's prepared remarks with a review of the company's financial performance during the Q2 ended June 30, 2023, before we open the call to questions. With that, let me pass the call over to Mike.

Speaker 2

Good morning, everyone, and thank you for joining us on the call. I'm really pleased to be here today and along with Susan and Justin to share with you the progress we've made over the past quarter. At the midway point of 2023, we are excited about the critical milestones we've achieved, the continued execution of our priorities An important two quarters ahead of us. Israel is making significant inroads in the IBS C market as healthcare practitioners and patients recognize the benefits Our growth rate accelerated with net sales revenue in the Q2 of $18,300,000 reflecting a 61% increase in net sales revenue over Q1. This performance is the result of the incredible efforts of the team that is fully engaged in the field, Calling on HCPs and articulating the unique value proposition that Idzrella offers patients who are in need of a new treatment option.

Speaker 2

At this stage of our commercialization of Idrela, we're excited to provide revenue guidance for the very first time. We currently expect Idrela net sales revenue for 2023 to be in the range of $72,000,000 to $77,000,000 Physician adoption, patient need and positive treatment experiences as well as a favorable access are the fundamentals driving our XERLLA growth. And we believe the strength of these forces continues to predict expanded use of XERLLA. As we've said, physicians are finding Xarelto be an important treatment option for their patients with IBS C. Patients are experiencing positive results and refilling their prescriptions.

Speaker 2

Access to IVDRELLA is favorable, Enabled by our best in class patient services program, Ardellix Assist. We are confident in the future performance of the Dorela And we hope that this guidance will offer better insight into our expectations for this product in the market. As it relates to EXFOZA, meaningful Progress has been made since we spoke in May. First, as we announced mid May, the FDA had set the review full review date for XPOSA of October 17, And we expect to launch XPOSA in the Q4 of this year as quickly as possible following approval. Market awareness, interest and intent to adopt XPOSA is high.

Speaker 2

We will have comprehensive sales, medical affairs, patient services and payer access support in place at launch. And as we get closer to launch, we will share more details on our expectations for EXPOSA and our launch plan to drive uptake and long term success. 2nd, as you may have seen, a bipartisan bill was introduced last week in the House of Representatives by Buddy Carter, Carol Miller, Annie Custer and Terry Sewell that would delay the implementation of the oral only policy under the Medicare ESRD Prospective Payment System for PPS through January 1, 2,033. The introduction of this bill is an important first step in extending the exclusion of the oral only ESRD drugs from the PPS. Currently, oral only phosphorus lowering treatments, which exposure would be considered upon approval, are scheduled to enter the PPS beginning in January of 2025, eliminating separate payment under Medicare Part D For the approximately 60% to 65% of CKD patients on dialysis who are covered by Medicare.

Speaker 2

We believe this important legislation is in the best to patients and we join the entire kidney community, advocates, patients, nephrologists and dialysis providers that support the efforts to advance it. Congress taking action to extend this exclusion as it has done 3 previous occasions will ensure that CKD patients on dialysis Continue to have access to personalized care and innovation. Pending approval of EXFOZA by the end of this year, Within 2 years, Ardelix will have launched 2 highly differentiated commercial products in markets for patients with significant unmet medical needs, Twice delivering on the vision of Ardelix, a feat few biotechnology companies have ever accomplished. Susan will now talk through the market dynamics and key performance metrics that are driving our success and accelerate the sales growth towards Rolla. Susan?

Speaker 3

Thank you, Mike. 15 months into the launch of Idrela, we are establishing a strong early market position, Disrupting the IBS C market by addressing the need for a novel mechanism treatment option. With a strong field force of more than 60 reps Having daily interactions with the top writing IBS C HCPs, we continue to focus on driving both breadth And depth of AZEDRA writing across HCPs for their patients who can benefit from a novel treatment approach. Our omnichannel digital tactics further amplify our commercial presence, enabling continuous engagement with existing writers as well as expanding awareness to cultivate new writers. With new writers continuously being added And existing writers increasing their prescribing, AZZRLLA is redefining the treatment landscape.

Speaker 3

Our Q2 sales performance and revenue growth over Q1 reflects the growing uptake of AZRLLA and the opportunity we believe this drug offers for a meaningful subset of patients That up until the launch of Estrella had limited treatment options. This market is highly promotion sensitive, our market presence is strong And the value proposition of Idrela is resonating with HCPs and patients. The May 2023 Launch Dynamics Tracking Report Published in Q2 by Spherix, an independent market research firm, provides a view of the market response to AZRELA based on a monthly Launch tracking survey across a sample of GIs. The May 2023 findings reported based on the 76 GI surveys That 91% rated Estrela as an advance over existing therapies. Additionally, of the subset of respondents who reported using 98% reported satisfaction with treatment.

Speaker 3

The May 2023 STRIC survey results also provide a view Of the strength of our targeted commercial presence in high IBS C writing ACP offices with 74% of survey TIs Reporting seeing an Ambrela rep, of which the majority reported seeing a rep within the last 3 months. These results align with the persistent growth that we are seeing in both new and refill prescriptions and the feedback we receive daily from HCP. ACPs are interested in Idrela, are engaging actively with our sales team, responding to our omnichannel communication, Adopting Idrela and continuously expanding their use across their practice based on their favorable treatment experience. Momentum is strong and the potential is high. We believe the opportunity for Distrugg to deliver sales for Ardellix Of $500,000,000 or more at peak is very real.

Speaker 3

Our commercial presence is strong and making an impact. The novel mechanism and clinical profile resonate with physicians. Patients are gaining access to the drug and seeing positive results. The need is clear, the opportunity is clear, the product is performing and the team is executing at the highest level. Commercial capabilities at Ardelix are strong, prudent and mobilizing to be prepared to launch EXFOZA if approved in the Q4 of this year.

Speaker 3

Marketing, distribution, payer access and patient services commercial ramp has been ongoing with the build out of the nephrology sales team now underway. Upon its approval, EXFOZA, like Idrela, will be a novel mechanism therapy entering into an established therapeutic area with limited treatment options And it's highly accessible via targeted focus on a concentrated number of HCP. Our strategy centers on treating nephrologists With a product positioning directed at patients with unmet medical needs and a path to access to bring this 1st in class phosphate absorption inhibitor, I look forward to continuing to report on our XERLLA performance as well as sharing more details on the XERLLA launch in the near future. With that, I will hand it to Justin.

Speaker 4

Thank you, Susan. Our Q2 of 2023 Reflect positive momentum on a number of financial metrics, accelerated sales growth, improvement to our gross to net margin as compared to last quarter, Shareable monitoring of cash expenditures and strengthening of our balance sheet in a methodical manner we have taken over the past several quarters. I will walk through those metrics now and then discuss the guidance we provided today for Xarelle net product sales in 2023. In the Q2 of 2023, we had total revenue of $22,300,000 compared to 2,500,000 The Q2 of 2022, reflecting increases to both our net product sales of Intrilla in our product supply and licensing related revenue. As previously mentioned, we had net product sales growth in Q2 2023 of $18,300,000 which is significant 61 percent quarter over quarter growth from the $11,400,000 we reported in the Q1.

Speaker 4

As a reminder, in the Q2 of 2022, Our 1st full quarter scale following launch, we reported net product sales of $1,600,000 We also recorded $4,000,000 in product supply and licensing related revenue in the Q2 of this year compared to $1,000,000 in the Q2 of 2022. Research and development expenses were $8,300,000 for the quarter ended June 30, 2023, which is a decrease of $1,400,000 from the $9,700,000 for the same quarter last year. Expenses in the prior year reflect higher Tenapro manufacturing expenses as well as costs associated with our appeal at The FDA's July 2021 complete response letter on the NDA for exposure. We saw our gross to net margin improve in the second quarter As we expected, as healthcare plans reset in the new calendar year, our gross to net was somewhat higher in the Q1 It has been in the 3rd and 4th quarters of 2022. We were pleased to see that our gross to net improved in the Q2 of 2023 Approximately 28%.

Speaker 4

We anticipate the gross to net market to continue to be in the high 20s for the remainder of 2023. Selling, general and administrative expenses were $27,200,000 for the Q2 of 2023, An increase of $8,300,000 went to $18,900,000 for the same period of 2022. The increase was primarily due to the increased costs associated with continued commercialization and growth of Exxara. For the quarter ended June 30, 2023, we had a net loss of approximately $17,100,000 or $0.08 per fully diluted share compared with net loss of $26,900,000 or $0.19 per share in the Q2 of 2022. The net loss for the quarter ended June 30, 2023 included $4,200,000 in combined non cash expenses I'm sure we have compensation and non cash expense.

Speaker 4

As of June 30, 2023, we had total cash, Cash equivalents and short term investments of $127,600,000 as compared to $123,900,000 at December 31, 2022. This reflects $11,600,000 we raised during the quarter Through sales of approximately 3,000,000 shares of common stock under our ATM program, we will continue to be patient and explore further opportunities to raise additional capital I'm now going to walk through some of the details of our financial expectations for the next 12 months. First, As you saw in our press release this morning and as you heard from Mike, for the first time, we shared full year net sales revenue guidance for a drop. 15 months following the launch, we continue to see sales trends moving in steady positive direction. Patients are refilling their prescriptions, Previously, writing HCPs are finding new patients and we have new HCPs writing every day.

Speaker 4

Our strategy to grow depth and breadth of writers is working. We are also gaining visibility into the patterns and dynamics of this launch each day, enabling us to make more firm projections. We currently expect net Imzrella sales revenue for full year 2023 to be between $72,000,000 $77,000,000 At the end of the Q2, we reported year to date 2023 net sales revenue of $29,700,000 This full year guidance range represents thoughtful consideration of continued growth consistent with the volume of new prescriptions we've seen, A favorable growth trajectory for refill prescriptions and strong demand and interest for this novel treatment. We have confidence in INZRELA's potential And we continue to be able to generate $500,000,000 or more in net sales revenue at peak. In addition, I wanted to address a question we received related to Symphony script tracking data.

Speaker 4

As we sought to understand the differences between our reported revenue In the Symphony script data, we have identified that the numbers reported by Symphony include prescriptions from the pharmacy that fulfills prescriptions Our Delta does not receive revenue from Patient Assistance Program prescriptions and for this reason The Symphony data does not directly tie to our reported revenue. In addition, as Susan shared, we will begin investing this quarter Prepare for the launch of EXPOSA in the 4th quarter, pending approval. When we launch EXPOSA, if approved and as we ramp up, We expect incremental expenditures to be approximately $20,000,000 per quarter. We hope to quickly drive uptake and establish a position for exposure Finally, as we've discussed in previous quarters, we will continue to strengthen our cash position by looking at all options available to us, including non equity solutions. As a reminder, we expect to recognize a $2,000,000 milestone payment In the Q3 from our partner in China, Oisin Pharma, following the acceptance of the NDA for TENAPANOR for hyperphosphatemia, which we announced earlier in July.

Speaker 4

In addition, assuming the approval of tapanabenor for hyperphosphatemia in Japan, we will earn another milestone payment later this year from our Japanese partner, Kibokir and Co. Led by the continued growth of Vistrella, we are in excellent financial position as we prepare for the exposure launch. We are confident in our ability to fund our operations and we will continue to make thoughtful decisions to maximize shareholder value. With that, I'll hand it over to Mike.

Speaker 2

Thanks, Justin. Q2 was another quarter where our Delt achieved important milestones, delivered on our priorities and strengthened our business. We are excited with Xrela's performance and are beginning to see upside for this product. The team behind Xrela is focused, dedicated and driven to help the patients that we serve. They have set a standard for the type of success and innovative thinking that can be expected from the Ardelix commercial organization.

Speaker 2

Demand for EXFOZA is high and we believe we have the potential for a strong launch after approval. We continue to support our partners' regulatory submissions, while engaging in discussions for further international expansion and looking at all the options available to us from a financing perspective. Before closing, I would like to take a moment, as I always do, to thank the incredible team Ardelix. Your talent, your passion and commitment Are the driving force behind the performance that we've shared today. I will now open the call to questions.

Speaker 2

Operator?

Operator

Yes. Thank you. We will now begin the question and answer session. And the first question comes from your call, Nikolas Wongowitz with Citigroup.

Speaker 5

Hi, Mike and team. Thank you very much. Could you just spend a little bit more time talking about the assumptions behind the newly introduced guidance range? Obviously, it implies a quarterly growth over Quarter over quarter growth, essentially lower than what you saw 2Q over 1Q for the back half of the year. So if you could Delve into that a little bit more.

Speaker 5

And then on the legislation with the bundling, can you talk about the likelihood that that legislation will come to fruition And then keep the oils out of the bundle to 2,033. Thanks.

Speaker 2

Sure. Let me start with the last part first is I feel like starting to sing Schoolhouse Rock as to How ability comes along. And so I can't give you any specific percentages on the probabilities. This is such an important first step. What we're focused on is making sure that the team is ready to launch in the Q4 pending approval, and we'll take it step by step.

Speaker 2

I think this is Such a strong message of what Congress has previously done 3 other times, that it gives me some hope and optimism, but I can't give you specific numbers. As it relates to the guidance, as I said and Justin, this is our first time giving guidance. We're going to take a very measured approach. I think as we look at How we performed since launch, there's different percentages growth quarter to quarter. So we're not going to just straight line things.

Speaker 2

We're going to take these In stepwise fashion as we have with this and I think this is a measured and appropriate first step for guidance. Justin, anything to add to that?

Speaker 4

Mike, that's excellent. Again, we're really encouraged by Q2's quarter over quarter growth and measured thoughtful and Really, Susan and the commercial team have done an amazing job and we'll keep you apprised on our progress.

Speaker 5

Thanks. And then just one quick question on the SYMPHONY. So the patient assistance program, can you say what percent of The script volume coming out of Symphony was driven by the PAP for which you don't book revenue?

Speaker 2

Yes. I mean, It's going to vary depending upon all the scripts, right? So there's not a specific percentage that we can say is going to be true last quarter to the next one, but it's just a big SAPAP program That shows up in Symphony. Okay. Thanks, Mike.

Speaker 2

Sure.

Operator

Thank you. And the next question comes from Dennis Ding with Jefferies.

Speaker 6

Hi, good morning. Congratulations on the progress and 2, if I may. For EXPOSA, what are your expectations into the October PDUFA, Including how the label could eventually shake out and how that would impact your positioning in the market. And Number 2, ever since the resubmission and acceptance, How have engagement with the FDA been? And what more needs to happen in the next 2 months into the PDUFA?

Speaker 6

Thank you.

Speaker 2

Sure. So I think as we shared when we said that we had refiled the NDA and as well with Doctor. Stein's letter, Frankly, all the discussions that occurred at the AdCom, we believe the likelihood is that this is going to be an indication that says something along the lines when Binders are insufficient or intolerable, which is the majority of patients as everyone knows. So I think that secures a very powerful second line Spot where all the binder, it's what almost 80% of patients are above range in any 6 month period of time. So we feel strong and feel good about if that's the indication ultimately ends up being.

Speaker 2

There's not really been any substantive communication with the agency, didn't Traditionally, you begin your negotiations on your package insert month or so prior to your PDUFA date. And if you recall, In our last go around, we negotiated the majority of the package insert, before what occurred to Ultimately end up in the CRL. So I don't know how much relitigation is going to have to be required for the PIs since that's already been done. But that's what we would anticipate. Thank you.

Speaker 2

Thanks, Dennis.

Operator

Thank you. And the next question comes from Laura Chico with Wedbush.

Speaker 7

Hey, good morning guys. Thanks for taking the question. I just wanted to circle back on the guidance real quick here. What I guess, maybe if you could explain, Mike, what gave this why was now a good time to start providing guidance? Was there anything that's changed Kind of in the trajectory or anything there, but yes, rationale around why now is a good time for guidance?

Speaker 2

Well, we said that we would do it in about 15 to 18 months from launch as we learned more about the data and got more comfortable. And I think as Justin said in his opening remarks that we're gaining confidence in those numbers being representative of where we're going. So That's really what generated it. It's we're 15, 16 months post launch and it just seemed like the right time. Justin, anything to add?

Speaker 4

No, I think that's right. Laura?

Speaker 7

Thanks, guys. Okay. And then if I could follow-up on one, just with respect to the legislation. I don't think we've And I know you mentioned we've already had the can kicked down the road 3 times previously. I guess just On the off chance the bill does not progress, I'm just wondering if you could kind of walk through mechanistically what would actually happen If it were included in the bundle, I guess I'm trying to work through the scenario of potential impacts during a transition.

Speaker 7

Yes. Thanks. If there's any color there you could provide.

Speaker 2

Sure. And to see the text of the bill, you can go to Buddy Carter's website, Congressman from Georgia, and the bill is there. As it relates to the bundle, it would End up being January 1, 'twenty five as it goes in and you ultimately are in a 2 year to DAPA period Like other drugs that have gone into like Senspar and Parsabiv, they collect the data from that 2 year period. And then The following year, they increased their base rate based upon a calculation on those data they collected, to increase the base rate to cover The cost associated with anything going into the bundle. I think what makes these oral only so unique is that they are not Given during the provision of dialysis, if you recall or as we've talked that in fact you're not allowed to eat when you're on dialysis.

Speaker 2

And Certainly, our package insert and others, say you have to take your drugs while you have food, right, whether it's A meal or a snack in the case of binders. And for us, it's one small pill before breakfast and whether it's dinner or lunch, your next largest meal. So it makes it a vexing issue for the providers to actually accomplish what they need to when they're not going to be getting these drugs during the provision of the dialysis services.

Speaker 7

That's very helpful, Mike. Last question, I'll hop back in the queue. In terms of ATM utilization, I think there was about $11,000,000 generated This quarter, could you just comment on kind of appetite for further use of the ATM? Thanks very much.

Speaker 2

Sure, Justin.

Speaker 4

Thank you. So we sold approximately 3,000,000 shares during the Q2 for gross proceeds of approximately $11,600,000 As we discussed in our prepared remarks, we're going to be very solid foundation in our capital raising ideas. So we're open minded to Non equity solutions as well as we continue to explore our options across both business development, Yes, and other non equity solutions. So, it's certainly a tool in our toolbox, but we are going to be patient and methodical as we've tried to be

Operator

Thank you. And the next question comes from Matt Kaplan with Ladenburg Thalmann.

Speaker 8

Hi, good morning guys and Congrats on the Adorella results for the quarter. Nice results. Just wanted to dive in a little bit more to Your preparation for the XFOZAL launch and going into the October 17 PDUFA, can you Just a little bit more color in terms of how you're thinking about the build out of that sales team and will it look like The Abzarella team or in terms of size and give us a little bit more color as you prep for?

Speaker 2

Sure, Susan.

Speaker 3

Yes. Hi, Matt. We are as we mentioned in our narrative, we have mobilized to prepare for the launch of Exposa. We have The capabilities to ramp up all the marketing, distribution, payer engagement, patient services. Your question on the sales force, we are fielding a dedicated Nephrology sales force and this market as we have noted around the IBS C market Has a very concentrated number of doctors with around 8,000 HCPs accounting for the majority of hyperphosphatemia scripts.

Speaker 3

So To really reach that target group, we are fielding a group of about 60, which we believe really will develop a very Establish a strong sales force presence for exposa with a dedicated nephrology sales force across the country. So it really is a sales force comparable inside to our Xarelto sales force. However, it is dedicated to the nephrology call point and we are experiencing a really high level of interest Because we're interviewing to fill those spots as we speak with very seasoned salespeople with coming in with nephrology Variance and established relationships, so we're quite enthusiastic about launching this dedicated team and we will be prepared to be able to launch As quickly as possible upon the approval of Exposa in the Q4.

Speaker 2

And Matt, the thing I would add to that is if you recall Before the CRL, we had an extensive disease awareness campaign in an organization that was feet on the ground doing that. And What's been remarkable is to see the continued awareness that has built even since then and the anticipation for it. So, we're enthusiastic Think about what we're going to be launching into.

Speaker 8

Okay. That's helpful. And then follow on to that is, I guess, why Should the EXFOZA launch look like the ISROLLA launch or why should it look different given, I Given what you just said, Mike, in terms of the level of awareness, etcetera, what should our expectations be in

Speaker 2

Yes. So I think what we'll do is hold on that. We will spend some more time, more dedicated time with everyone As we get closer to the PDUFA date, telling you more about our expectations and how that's going to look. I think we're still gathering perspectives on it. We think it's going to be We had a positive response to the launch, but quantifying that at this stage is probably premature.

Speaker 8

Okay. Fair enough. And last question in terms of the profitability. I think in your prepared remarks, Justin, you mentioned incremental increase in SG and A. Can You just go over that again and how would you think about that?

Speaker 4

Yes. Thank you, Matt. So we're we'd like to We anticipate an additional incremental $20,000,000 in combined SG and A spend With some additional product supply spend starting in this quarter and going on, that will be the incremental cost. Of course, Once the drug is in the market, we're generating revenue there, it will be offset by the proceeds from net revenue. But We're guiding you to an incremental $20,000,000 in the quarter respectively.

Speaker 4

Thanks

Speaker 8

again.

Operator

Thanks, Matt. Thank you. And the next question comes from Peyton Bonsack with TD Cowen.

Speaker 9

Hi, guys. Thanks for taking our questions. I guess A little more on the GDAPA that you mentioned. So I'm assuming that you have to apply for this. Is my assumption that you guys would apply for this If it wasn't put in the bundle, however, Mike, that may be?

Speaker 2

Yes. I mean, whatever the process is To get those data collected, we would certainly participate in that.

Speaker 9

Got you. And then I guess as kind of like a follow-up, How have kind of discussions been going for other areas, like specifically Europe? Have you begun to move forward as we get to those? And If you have any time lines, that would be great.

Speaker 2

Yes. So we've had ongoing discussions in all the unpartnered territories, whether it's IBS C in Japan, Europe, Rest of World, those conversations continue. Some there's better trajectory than others. No Specific time line that I can give you in terms of when anything like that would be finalized.

Speaker 9

Great. And I guess just like one final one for me. Seeing how you guys are pretty deep into the Idriella launch now and the Vodaf is probably going to get approved and then launched. Could you maybe talk about your long term Your internal R and D strategy, would you guys restart your earlier stage pipelines or would you be looking to license something?

Speaker 2

Yes. I mean, it's a great question. As we've said, There's a couple of programs that are sort of laying fallow at this point to oppose these metabolic acidosis, the hyperkalemia program To speak of 2, that with sufficient capital, obviously, looking at those and restarting those would be a prudent thing to do. I I think what we're also demonstrating, Payton, with what we've done with XERLYN, I'm confident we'll demonstrate with Exposa is an Ordinarily powerful commercial organization that should be the partner of choice for new and upcoming drugs in IBS and So we'll continue looking across multiple ways of strengthening our pipeline As we get to a place where we have a strong enough balance sheet to do that.

Speaker 9

Great. Thank you very much. Appreciate all the color.

Speaker 6

Thank you, David. Thank you.

Operator

And this concludes our question and answer session. I'd like to return the conference back over to President and CEO, Mike Rauch for any closing comments.

Speaker 2

Thank you everyone for joining us this morning. I look forward to providing you with further updates in the weeks months ahead. We have a number of milestones that I look forward to sharing including an approval of EXPOSA In October and continued growth of EXPARELA. With that, we can close the call. Thank you, operator.

Operator

Thank you. The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.

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