Tvardi Therapeutics Inc (TVRD) 2022 Q2 法說會逐字稿

Good afternoon. My name is Denise, and I will be your conference facilitator. I would like to welcome everyone to Cara Therapeutics Second Quarter 2022 Financial Results and Update Conference Call. (Operator Instructions) Please be advised this call is being recorded.

At this time I'd like to introduce Iris Francesconi, Chief Strategy Officer and Head of Investor Relations from Cara Therapeutics. Ms. Francesconi, you may begin your call.

Thank you, Denise, and good afternoon. Just after market closed today, we issued a press release detailing our corporate progress and financial results for the second quarter 2022. The press release can be found on our website at www.caratherapeutics.com. You may also listen to a live webcast and a replay of today's call on the Investors section of the website. Participating in today's call are Chris Posner, Cara's President and Chief Executive Officer; Ric Makara, Cara's Interim Chief Financial Officer; and Dr. Joana Goncalves, Cara's Chief Medical Officer.

Before we begin, let me remind you that statements made on today's call regarding matters that are not historical in fact are forward-looking statements within the meaning of the Private Security Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the company's ability to successfully commercialize KORSUVA injection and Kapruvia; risks that KORSUVA injections and Kapruvia revenue, expenses and costs may not be as expected; planned future regulatory meetings and/or submissions and potential future regulatory approvals; the performance of the company's commercial partners, including Vifor; expected timing of the initiation, enrollment and data readouts from the company's plans and ongoing clinical trials; the potential results of ongoing clinical trials; timing of future regulatory and development milestones for the company's product candidates; the potential for the company's product candidates to be alternatives in the therapeutic areas investigated, including NP; and the potential for oral difelikefalin to address additional pruritic indications; the size and growth of the potential markets for pruritus; the company's expected cash reach and the potential impact of COVID-19; geopolitical tensions and macroeconomic conditions; and the company's clinical development and regulatory time lines and plans.

Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics' filings with the Securities and Exchange Commission, including the Risk Factors section of the company's annual report on Form 10-K for the year ending December 31, 2021, and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2022.

All forward-looking statements contained in today's call speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

With this, I will now turn it over to Chris.

Thanks, Iris, and good afternoon, everyone. The second quarter was truly foundational for Cara, building the base for our continued growth this year and in the years ahead. We made big strides towards our goal of creating a differentiated company and becoming the world leader in pruritus. Our focus is on treating this distressing underserved condition that affects millions of patients across many diseases.

The second quarter showed us we are on the right path with concrete validation of our strategy. Along with our partner, Vifor Pharma, we made significant progress in the launch of KORSUVA injection. For the second quarter, we recorded total revenues of $23 million. This consisted of $8 million in profit sharing revenue from KORSUVA injection and $15 million in a milestone payment from the EU approval of Kapruvia in April. In addition, our strong Phase II proof-of-concept data in notalgia paresthetica highlighted the broad potential of our oral difelikefalin platform. I will give more details on our progress this quarter, and Rick will follow with a review of our 2Q financial results. After that, we will take your questions.

In the first quarter on the market, KORSUVA's adoption dynamics are in line with our expectations and in line with the only recent branded product launch in the setting. Specifically, independent and mid-sized dialysis organizations have been the first to adopt and administer KORSUVA injection. The more rapid product adoption by these organizations is predominantly due to: A, shorter contract negotiations; B, simpler technical implementation of product information, pricing and reimbursement in respective to EMR systems; and C, faster establishment of treatment protocols.

We have heard positive anecdotal feedback from the field on the performance of the product. Week-to-week, we have seen an increase in the total number of clinics ordering, and we have seen repeat orders across the majority of clinics.

Turning to the large dialysis organizations, which make up 75% of the market. They are more complex, and therefore, take somewhat longer with regard to all these steps. However, we are pleased to report that those key elements are in place at the LDOs and they have started to order KORSUVA early in the third quarter.

These early launch dynamics, which are typical of the dialysis market, support our reported product launch metrics. Vifor's net sales of KORSUVA injection was $17 million. This comprises mostly the initial stocking at the wholesaler based on the anticipated demand from LDOs coming online. We expect that a significant portion of this inventory will get sold into dialysis clinics in the third quarter.

The wholesaler shipment to dialysis clinics was about 2,000 vials, reflecting the early but rapid adoption in the independent and mid-sized organizations. We have seen demand from this market segment also accelerating.

As we head into the third quarter, more firepower has been added to develop the market and help drive product adoption. Specifically, we are pleased with the addition of the Fresenius Renal Pharma's sales force to the promotion of KORSUVA injection. The Fresenius sales force will focus exclusively on Fresenius dialysis clinics and affiliated health care providers. This will significantly increase our share of voice in Fresenius clinics, and we expect Fresenius to be a major driver of product sales in the coming quarters.

It is also important to note that Vifor's promotional plan has not changed, and its sales force will continue to promote KORSUVA to health care providers associated with both Fresenius and non-Fresenius clinics. Lastly, we are pleased with the recent CMS rule proposal that includes a request for information regarding an appropriate payment mechanism for drugs with TDAPA designation post the TDAPA period. We generally believe that the different payment mechanisms outlined in CMS' proposal would provide adequate reimbursement for KORSUVA post the expiration of its TDAPA period.

We further support the concept of linking drug payment to drug utilization in appropriate patients. While we do not expect a final decision by CMS regarding the post ADAP reimbursement mechanism this year, we are confident that CMS is focused on ensuring long-term access to innovative drugs like KORSUVA.

Our pipeline is another potential exciting driver of long-term growth. We continue to validate oral difelikefalin's potential across many indications and diseases. The recent positive top line results in our KOMFORT Phase II proof-of-concept trial for oral difelikefalin in notalgia paresthetica shows the potential broad applicability of DFK in chronic pruritus.

NP is a nerve disorder characterized by chronic pruritus of the upper to middle back and treated by medical dermatologists. Like all our other programs, there are no approved treatment options for NP and currently used treatments have limited efficacy or safety concerns. The KOMFORT study met its primary endpoint of change from baseline in daily WI-NRS score at week 8, showing a highly statistically significant difference from placebo. Oral difelikefalin had a rapid onset of efficacy as early as week 1, which was sustained throughout the entire study period.

DFK also reached statistical significance on the additional endpoint of proportion of patients with a 4-point improvement in the WI-NRS score starting at week 2 and through week 8. DFK was well tolerated with a safety profile consistent with prior studies and other indications. We plan to share the detailed clinical data from this study at an upcoming medical meeting.

We also expect to meet with the FDA in the second half of 2022 to discuss the next steps in the development for notalgia paresthetica. We will provide more details for this exciting program at a later time.

In our other pipeline programs, we continue to expect releasing top line results for our Phase II proof-of-concept study in primary biliary cholangitis in the second half of '22. Our Phase III programs in atopic dermatitis and nondialysis-dependent chronic kidney disease, which we initiated in the first quarter of 2022, continue to track to our previously announced time lines.

In summary, the second quarter has set the foundation for both our near- and long-term growth, and we are executing on our 3 strategic priorities. The first priority is to maximize the commercial potential of KORSUVA injection with our partner Vifor Pharma. One quarter into the launch, we are tracking to our expectations. Demand was initially driven by independent and mid-sized dialysis organizations. LDOs have started to order. And the key demand levers are in place, including more sales force firepower. We like the cadence of how these are coming together to drive an acceleration of demand in the coming months.

We continue to execute on our second strategic priority of advancing our Phase III program for oral difelikefalin in advanced chronic kidney disease and atopic dermatitis. And we made significant progress on our third priority to expand the clinical utility of oral difelikefalin across a spectrum of disease categories associated with pruritus. The positive Phase II NP data validate the broad applicability of the oral difelikefalin platform.

We are excited and confident for what is ahead. The progress across our strategy in the second quarter is a foundational step toward delivering long-term sustainable growth and value for our shareholders.

Now I'd like to hand it over to Rick for details on our second quarter results. Over to you, Rick.

Thanks, Chris. As a reminder, the full financial results for the second quarter of 2022 can be found in our press release issued today after the market closed. Cash, cash equivalents marketable securities at June 30, 2022, totaled $204.7 million compared to $236.8 million at December 31, 2021. The decrease in the balance primarily resulted from $30 million of cash used in operating activities.

For the second quarter of 2022, net loss was $4.2 million or $0.08 per basic diluted share compared to a net loss of $30.7 million or $0.61 per basic and diluted share for the same period in 2021. Total revenue was $23 million for the 3 months ended June 30, 2022. There was no revenue during the same period of 2021.

Revenue consisted of $15 million of license and milestone fee revenue related to the milestone payment earned for the approval of Kapruvia by the European Commission in April 2022 and $8 million of collaborative revenue related to the profit sharing revenue from Vifor's sales of KORSUVA injection to third parties.

There was no cost of goods sold during the 3 months ended June 30, 2022 or 2021 as there was no commercial supply revenue for either period. R&D expenses were $19.9 million for the 3 months ended June 30, 2022, compared to $25.2 million in the same period of 2021. The lower R&D expenses were principally due to a $10 million milestone earned by Enteris during the 3 months ended June 30, 2021, partially offset by increases in direct clinical trial costs and related consulting costs during the 3 months ended June 30, 2022.

G&A expenses were $7.6 million for the 3 months ended June 30, 2022, compared to $5.7 million in the same period of 2021. The higher G&A expenses were principally due to increases in stock-based compensation expense, which included additional compensation expense relating to the modification of the company's former Chief Executive Officer's equity awards in November 2021 as well as increases in accounting and auditing fees and payroll-related costs.

Other income was $0.3 million for the 3 months ended June 30, 2022, compared to $0.1 million in the same period of 2021. The increase was primarily due to an increase in interest income resulting from a higher yield on the company's portfolio of investments during the 3 months ended June 30, 2022, partially offset by an increase in net amortization expense of available-for-sale securities during the 3 months ended June 30, 2022.

Now looking forward to financial guidance. Based on timing expectations and projected costs for current clinical development plans, which include conducting supportive Phase I trials, Phase II trials in PBC and NP and Phase III trials in CKD and AD, Cara expects that its current unrestricted cash and cash equivalents and available-for-sale marketable securities will be sufficient to fund its currently anticipated operating expenses and capital requirements into the first half of 2024, without giving effect to product revenue we receive from the commercialization of KORSUVA injection or Kapruvia or any potential milestone payments or potential additional product revenue we may receive under collaboration agreements.

Now I'll turn it back over to Chris.

Thanks, Rick. With that, Rick, Joe and I will be happy to take your questions. So Denise, we can now open the call up for questions.

(Operator Instructions) Our first question comes from the line of Daniel Wolle with JPMorgan.

Congrats on the quarter. Three questions. First one, can you help us understand the wholesaler number of 1,812 vials and how that translates to $60 million in net KORSUVA sales? Second, can you provide us with some color on the cadence of coding establishment or reimbursement establishment at different dialysis centers during the quarter and how that might evolve in the following quarters? And last but not least is related to that. Can you qualify for us your remarks regarding the net sales that are mostly due to wholesaler versus end-user demand?

So let me take those one at a time. So the first is around the net sales number. It's about revenue recognition. Essentially, it's a timing thing. So we book revenue when the wholesaler -- or when -- sorry, when Vifor ships product to the wholesaler. So that's when we recognize revenue. The 1,812 vials are what the clinics order from the wholesaler. So there's 2 different things in the revenue recognition. So that's an important part.

And the second question you had was around coding. And essentially, what we're asking is, are the dialysis organizations ready to provide access to this product? Are they set up? And the short answer is yes. On the LDO front, they are ready. The systems are updated. And in fact, as I mentioned, we are actually seeing orders beginning in the third quarter. So we're actually quite optimistic about what we should expect in the months to come.

Right. And then last but not least, if you can quantify the remark that mostly what you saw was wholesaler stocking versus end-user demand?

Yes. So again, the way we book revenue, Daniel, is we recognize that when Vifor ships vials to the wholesaler. So that's the $16.8 million in net sales. So what we're also then providing -- and if you remember, I committed to providing the number of units that the dialysis clinics have actually ordered from the wholesalers as we believe that's a good proxy for end-user demand. So that's the 1,812 vials. So 2 different things. So it's not as simple as just multiplying the WACC price times the number of vials. Twop different things.

Our next question comes from Chris Howerton with Jefferies.

Great. I think I have 2. One kind of related to the line of questioning that Daniel had about the wholesaler and the stocking. I guess how can you -- can you give us a little more color, I guess, on kind of the expectations we could have on the organic demand from the larger institutions? And I guess if you could comment at all about Fresenius versus DaVita? My assumption would be that Fresenius would be easier to execute on that side given the relationship with Vifor.

And then the second question that I have is related to the NP indication. Just what types of features would you seek to gain alignment with on the FDA regarding presumably the Phase III design? And then sugue related to that, in the past, there was discussions about getting a very broad label for oral KORSUVA for just a broad antipruritic. I'm curious if you're still on track for that in relation to the different domains of indications.

So let me -- I'll tackle the first one. I'll turn it to Joe to tackle the NP. So let me be -- I'll be crystal clear -- or I'll try to be crystal clear in terms of channel stocking and demand. I'm going to take both of those separately. So channel stocking, our channel strategy, it's an important part, as you probably know, of any launch strategy. And levels are defined in accordance with future demand as projected by Vifor. So Vifor put product into the channel anticipating future demand. That's the channel strategy.

And I'm quite pleased with how that progressed. And that's how we booked the $16.8 million in total sales, and obviously, Cara's profit is $8 million. But the key is demand. And essentially, what I'm saying is the future demand is going to be really dependent on the LDOs coming online. And that's exactly what we're seeing. They came online just more recently. And we're seeing ordering already. So it's on formulary. We're seeing ordering.

I can't comment specifically on the different customers. You mentioned Fresenius and DaVita. I can't comment specifically on those 2 customers, but I will say that we are quite pleased. I was quite thrilled with the addition of the Fresenius sales force to the mix. That's additive and complementary to Vifor. So we would fully expect the LDOs gradually adopting this product and really contributing to the majority of growth moving forward.

And Chris, it's a very similar pattern we actually saw with Parsabiv, where the MDOs, the midsize, and the IDOs with the initial uptake, with more gradual uptake in the LDOs and then becoming the majority of the growth. And I would expect that same sort of sequence and that's exactly what we're seeing.

So on the NP, Joe, if you want to tackle that one.

Thanks, Chris. So with the FDA, we plan to have further discussions about our clinical development program before the end of the year, this year, and it would really be focused on what the clinical development program would look like. We know we need to do some dose finding. The discussion will be what that program would look like. Of course, Cara will try to see if we can accelerate the program to include that dose finding as well as validated studies. So we expect that to revolve around typical questions that need to be asked of the FDA for developing a clinical program.

As far as the broad label goes for difelikefalin as a board label, we'll first tackle the NP part and then take it from there and give further updates after that meeting.

Congratulations again.

Thanks, Chris.

Our next question comes from Joseph Stringer with Needham & Company.

Congrats on the quarter. Can you comment on the initial -- the margins from Vifor here coming from net sales down to -- before the profit loss share is applied just in terms of what's the sort of percentage there? And is that in line with sort of what you would expect going forward in subsequent quarters?

And then on the Kapruvia launch, can you kind of walk us through the cadence of when you would expect sales contribution from that as country-specific reimbursements come online?

Let me give the financial profit sharing to Rick, and then I'll tackle the Kapruvia one. So Rick?

So we don't provide specific guidance on the profit share calculation. But what I can tell you is that based on the net sales for the quarter, the profit share was within line with our expectations. So we were not surprised by it, if that helps.

And Joey, on Kapruvia, obviously, we're quite excited. We got approval in April of this year, and we're on track to launch in several countries in the second half of this year, obviously, with our partner Vifor. So I would anticipate seeing some launch countries come online.

In terms of kind of the market development, I would say Vifor has done a very nice job in terms of developing the market as they did in the U.S. And they're doing a similar cadence of market development activities outside the U.S. And as countries come online, that's really going to be dependent on reimbursement and their negotiations with the national payers. So I would expect, again, a few countries to come online in the second half of this year.

Our next question comes from David Amsellem with Piper Sandler.

So had a near-term focused question, and that's about the quarterly sales and profit sharing cadence. So you mentioned, Chris, the wholesaler stocking. So I apologize if I missed this, but does it stand to reason then that perhaps the recorded sales and profit share in 3Q might be somewhat softer? Or because you're getting buy-in from the large dialysis organizations, that you're going to see Vifor continue to sell into the channel? So just help us understand how we should think about cadence in 3Q and, I guess, fourth quarter as well? And then I have a follow-up.

No, no, certainly, David. Let me tackle that one. So with any launch, I mean, especially the way we record revenue when -- obviously, Vifor ships to wholesalers, and then there's the demand generation. So it's really a matter of timing. So here's what we would expect. We would expect, obviously, demand to accelerate given that Fresenius and DaVita, the LDOs, are really online now. We're on formulary, protocols in place, systems updated. And we're already starting to see some ordering at those clinics.

And it's a marketplace dominated by really 2 customers. They account for 75% to 80% of all the dialysis patients. So demand will accelerate. I would fully expect to launch inventory, as mentioned on the call, to get drawn down accordingly in the third quarter and into the 4.

But to me, it's really about demand. And that's where I'm encouraged and I'm excited when you layer on the Fresenius sales force, coupled with obviously getting on the formulary and getting protocols in place and the staffing trained. I'm very optimistic that we're going to experience a good acceleration. And as with most launches, between the trade inventory and the end user demand, that will reach some sort of steady state in the next few quarters.

Okay. That's helpful. And then the follow-up is regarding inventory. Can you just talk about what we should think about in terms of steady state? How many weeks in the channel is steady state? And is it fair to assume that inventory levels are customarily going to be tightly managed here?

Yes, I would take the latter part of your question. And when I say steady-state inventories, I would say it's more customer. Clearly, Vifor put product into the channel with the anticipation, rightfully so, of demand. And that's the channel strategy at launch. And that's exactly what we saw and that's exactly what they executed. I would -- exactly as you said, I would see steady state with inventory at very tight and where sales -- net sales is probably more congruent to end-user demand during steady state.

Our next question comes from Oren Livnat with H.C. Wainwright.

I have a couple. If I could follow up on the earlier question about margins. Obviously, you can't give guidance for Vifor. But we can all do math here. And I think you reported collaboration revenue of 47% about of net sales, which assuming it's a 60% profit split in non-Fresenius accounts, I can back into a nearly 80% operating margin for the sales to date.

And I just want to make sure before we get silly and carry numbers like that forward, should we assume that there maybe are some material costs that were not grossed against those numbers this time around considering it was just channel fill from a -- I guess, a Vifor accounting perspective? Or can we just go ahead and say, "Wow, as this drug grows, it's only going to be at least this profitable going forward"? And as we start thinking about -- as we model our revenue, how much we should estimate it to close to you? And I have a follow-up.

You got it, Oren. Let me give Ric the first question.

Yes. So on the profit share, yes, I mean, you did the math, right? And like I said when I got the initial question, based on net sales of just under $17 million, a profit share of $8 million was within what we expected. So that wasn't a surprise for this quarter. And going forward, it shouldn't be that much different.

I guess that's why somebody bought Vifor.

What's that, Oren? Go ahead.

I said I guess that's why somebody acquired Vifor, because that's a lot of profit.

Yes, it's in the horse ring, as they say, Oren, kind of what we saw this quarter.

All right. And you can -- if you had something else to follow up on that. And I have another question, unrelated.

No, go ahead. Go ahead, Oren.

Okay. Great. Sorry about that. Just regarding the timing of the large dialysis centers coming on board, I mean, I had assumed sort of right out of the gate that Fresenius, I guess, would be the most likely earliest indicator or earliest adopter just given the setup. And it sounds like they are just coming online into the third quarter. And I'm wondering if there was any hang-up there? Because I thought in early May, you talked about having all the sort of reimbursement and pricing data sort of online or in systems, which I assume to mean Fresenius and DaVita as well. So what would be the reason why it would take months to sort of start seeing the first orders coming in from the LDOs?

Yes. So Oren, I would say this. I mean, Vifor has done a really nice job working across the board with the LDOs, the MDOs and the IDOs, I mean this is not sequential, right? They do this all at the same time. MDOs and IDOs, we fully expected to come online earlier. They're just smaller organizations. A typical MDO may have 200 clinics. And so what has to transpire is, obviously, and you probably know this, it's the -- to get on formulary, you got to get protocols in place, get on formulary contracts in place and then ensure the systems are updated and the staff is trained, because we're changing the way dialysis is done. So that's a much quicker process in the MDO and IDOs.

On the LDOs, yes, I mean, it took -- they're more complex, quite frankly. And they took a little longer, as we expected, versus the MDOs and IDOs. And what -- I wouldn't say there's any hangups. It's just part of the process. And you're taking like a Fresenius that may have 2,800 clinics. And you're not only getting protocols and contracts in place, you're making sure all the staff is trained and the systems are updated so they could order.

So that's what I mentioned in my prepared remarks. I'm actually quite pleased that they were able to implement these contracts that quick. And given now that the sales force of Fresenius is also on board, I mean, it provides me and our team here as well as Vifor, obviously, with a lot of optimism now since the LDOs are the market essentially.

Our next question comes from Jason Gerberry with Bank of America.

I was wondering if you could talk a little bit about the 2 large deals and just the sort of treatment protocol decision-making. Is this sort of a singular top-down decision that permeates all the clinics within the LDO? Or is the decision-making more fragmented? Just sort of wondering if you can kind of shed a little more light on that dynamic?

And then thinking about just the commentary about 3Q with the ordering patterns, I mean, are we talking about sort of small, medium, large in terms of just the indication of demand that you're seeing for 3Q?

Jason, yes, certainly. So the protocols, especially at the LDOs, are centralized. And then they're pushed down to the individual clinics. So in terms of the protocols, I can't speak specifically to protocols on Fresenius, DaVita or any of the MDOs. But what I can tell you is that they're not rate limiters. If a physician identifies an appropriate patient, they get the product. That's the good thing.

And I think the other thing I would comment on is why we're so encouraged, is that the systems -- getting the systems and getting folks trained up across all these clinics is a process. And we're actually seeing that come to fruition and actually with some speed. So we're quite thrilled about what we're seeing in terms of the dynamics and demand generation.

When it comes to Q3, as I mentioned before, I mean, given the channel strategy and the launch inventory, we would fully expect that to burn down in Q3 in congruence with the acceleration of demand. And how that looks in Q4, we'll have to see how demand transpires. But as you know, right now, between us and Vifor, we're not giving any forward-looking guidance around sales and demand.

Great. That was the end. No more questions. At this point, I would like to turn it back to Cara management for closing remarks.

Well, thank you, Denise. And really thanks, everyone, for joining us today. And I'm wishing everybody a great week ahead.

Thank you for your participation in today's conference. This concludes the program. You may now disconnect.