Xeris Biopharma Q2 2023 Earnings Call Transcript

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Provided by Quartr
August 8, 2023

There are 8 speakers on the call.

Operator

Good morning, all. I would like to welcome you all to the Zillow Biopharma Second Quarter 2023 Financial Results Call. My name is Brika, and I will be your moderator for today's call. All lines are on mute for the presentation portion of the call today, with an opportunity for questions and answers at the end. I would now like to pass the conference over to your host, Alison Wei, Senior Vice President of Investor Relations and Corporate Communications to begin.

Operator

So Allison, please go ahead.

Speaker 1

Thank you, Brika. Good morning, and welcome to Xeris Biopharma's 2nd quarter financial results conference call and web A press release with the company's financial results was issued earlier this morning and can be found on our website. We are joined this morning by Paul Adich, Chairman and CEO and Steve Piper, our CFO. Paul will provide opening remarks, Steve will provide details on our financial results, then we will open the call for Q and A. Before we begin, I would like to remind you that this call will contain forward looking statements by which may include, but are not limited to, statements concerning our business This is our financial results, future expectations, plans, prospects, clinical approvals, commercialization, corporate strategy and performance, which constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Speaker 1

Actual results may differ materially from those indicated by the forward looking statements made during this call as a result of various factors, including our financial position and need for financing, including to fund our product development programs or commercialization efforts, Whether our products will achieve or maintain market acceptance in a competitive business environment, our reliance on third party suppliers, including single source suppliers, our reliance on third parties to conduct clinical trials the ability of our product candidates to compete successfully with existing and new drugs Adverse effects of macroeconomic conditions on our business operations and clinical activities and our Any forward looking statements on this call represent our views only as of the date of this call It should not be relied upon as representing our views as of any subsequent date. Subject to obligations under EFCO law, We disclaim any obligations to update such statements. I'll now turn the call over to Paul.

Speaker 2

Thanks, Alison. Good morning, everyone, and thank you for joining us today. For the past several quarters, I've started by reiterating what kind of company we're building at Cerus. I'm excited to once again say that the entire organization continues to execute, Performing at a high level and absolutely delivering on our vision. What I hope you take away from today's call and our continued positive performance Is that everyone at Xeris remains intensely focused on delivering for patients by continuing to build a substantial patient centric, Commercially focused and self sustaining biopharma enterprise.

Speaker 2

I believe that all three pillars of our business, multiple growing commercial products, a highly targeted development and value added technology partnerships are contributing to our vision and will result in long term shareholder value. I'll start with key highlights of another record quarterly performance. We recorded total revenue of $38,000,000 in the 2nd quarter, A 50% increase from Q2 of 2022 and a 14% increase from Q1 of this year. This is our 3rd consecutive quarter of at least 50% revenue growth year over year. We ended the 2nd quarter with over $80,000,000 in cash, Cash equivalents and short term investments, a very healthy cash position to support our continued growth.

Speaker 2

Based on our performance year to date And our outlook for the rest of 2023, we have tightened our full year 2023 guidance as well. Our revised guidance for 2023 is Total net revenue of $145,000,000 to $165,000,000 cash utilization of between $57,000,000 $67,000,000 and 2023 year end cash balance of between $55,000,000 $65,000,000 Importantly, we remain on track to hit a cash flow breakeven point by year end 2023 and will continue to be a self sustaining company thereafter. Steve will get into more of our financial performance in some detail later on. Onto the first pillar of our business, our growing commercial products. All three products, gVOTE, KEVEYIS and RECORLEV showed strong growth, collectively generating approximately $37,000,000 in net product revenue in the 2nd quarter, An impressive 46% increase over Q2 last year and a 14% increase over Q1 2023.

Speaker 2

Let me break it down in one product at a time. First, Gvoke. Gvoke had another record quarter of net revenue in prescriptions, totaling $15,600,000 in net revenue, a 30% 36% increase compared to Q2 of 2022. Total prescriptions for the Q2 were over 51,000, growing 50% compared to the same period last year And a 12% increase from Q1 2023. Throughout the Q2, GVok has averaged approximately 4,000 prescriptions per week And has recently hit a new all time record of over 4,500 prescriptions in the most recent weekly data.

Speaker 2

Market growth for glucagon products is back to consistent double digits. Gevo continues to outpace all of the products by driving the majority of the market growth. We also continue to capture market share. At the end of July, GVOC market share of new and total prescriptions in the retail glucagon market grew to approximately 31% 29% respectively. The new ready to use glucagon products now represent 79% of new prescriptions and over 77% of total prescriptions.

Speaker 2

We are in back to school season now and with the latest weekly record high, we believe we are starting to see the bump In weekly prescriptions that recurs annually during late July August, accompanied by an uptick in overall market growth. To build on GVOK's momentum later this year and going into 2024 in the now double digit growing glucagon market, We are investing in another modest expansion of our inside sales force. We will be adding 20 inside sales reps in the Q4 this year, bringing that force to a total of 50. We have proven this group can be a highly productive rather quickly in generating GVOC awareness, fueling market growth and gaining GVOC share. Also, you may have seen last week, gVolk hit a major milestone over 1,000,000 gVolk units have been shipped since its launch in late 2019.

Speaker 2

We are extremely proud of this achievement. We are just however, we are just scratching the surface of this opportunity. There is a long way to go until 15,000,000 people with diabetes who are at increased risk of a severe low blood sugar event are carrying a ready to use glucagon Such as givokaipopan. The key to a major change in this situation is the healthcare professionals who manage these patients. To address this critical situation and motivate healthcare professionals to do more, the ADA, the Endocrine Society, The Association of Clinical Endocrinology and Other Professional Societies have revised their guidelines or algorithms in some manner To advocate that the standard of care for all insulin and sulfonylurea treated patients should be that they are also prescribed a ready juice glucagon, So they are protected against a potentially life threatening severe low blood sugar event.

Speaker 2

Based on the latest available data, there are over Still over 240,000 emergency department visits, 60,000 hospitalizations and tens of thousands of deaths annually due to severe low blood sugar. These are avoidable with the new innovative ready to use Glutgen products as are the associated healthcare costs. On to Recorlev. Recorlev generated $7,200,000 in net revenue for the 2nd quarter, an increase of over 6 40% from the same period in 2022, which was its 1st full quarter since launch and an increase of 60% over Q1 of this year. We're very pleased with And 33% respectively over the Q1.

Speaker 2

Even more impressive is that we are increasingly seeing the Korlyv being prescribed As a patient's 1st drug therapy for a growing number of current referrals. This means that healthcare professionals are seeing some positive results From therapy and using recorlev and increasingly valuing recorlev as a first line treatment for Cushing's syndrome post surgery. Again, building on our momentum of accelerating referral rates, rising conversion rates and with the expected growth in the market, We will also be in further invest in expanding the Corlelo sales force to approximately 30 in the Q4 to take advantage of our momentum going into 2024. Moving to KEVEYIS. KEVEYIS had another great quarter in terms of revenue, new referrals and patients on therapy, Despite the fact that there has been an approved generic since the end of last year, 2nd quarter revenue for KEVEYIS was over $14,000,000 Which represented an increase of 10% compared to the same period in 2022.

Speaker 2

Our referral rates have also continued to grow approximately 8 10% compared to the Q2 of 2022 as we continue to identify new patients. The average number of patients on KEVEYIS grew about 11% compared to the 2nd quarter last year. To date, we have seen how generics may impact the payer process and have taken measures to maintain and support our patients. We know it takes more than dichlorphenamide to treat patients' primary periodic paralysis. There is a heightened focus on the value of our XERIS Care Connections team, patient advocates and mentors to support our PPP patients and healthcare providers through screening reimbursement authorization, Initiation of therapy and the long process of titration to most effective dosage.

Speaker 2

On to the second pillar of our business, pipeline development. In the Q2, we began enrolling patients in Phase 2 study of our Xerasol Levothyroxine, a potentially once weekly subcu injection And that study is now about 25% enrolled. As we've said previously, the study will be rather slow to fully enroll. The study design required subjects As expected, while we have screened many subjects taking chronic oral Levothyroxine, a significant number have failed to meet The standard for stability over 3 months. Further to the evidence that the challenge associated with oral thyroid Hormone replacement therapy, which speaks directly to the unmet need we aim to address with our once weekly subcu.

Speaker 2

To enhance our pace of enrollment, we're currently adding additional clinical research sites in order to maintain our goal of completing the study in the first half of next year. Data from the Phase 2 study, as we've said previously, will help inform our proposal to the FDA for a pivotal Phase 3 program. We believe that our once weekly subcutaneously volt thyroxine, if approved, will compete in a potential $2,000,000,000 to $3,000,000,000 market segment calculated at current brand prices. Now on to the 3rd pillar, our Xerus Technology partnership business. The 3 XerajeQ partnerships that we have with Merck, Horizon and Regeneron are all in various stages of development and continue to meet or exceed our partners' expectations.

Speaker 2

First for Merck, we have completed several rounds of ZERATEK formulation and formulation optimization. We have met 100% of the agreed upon specifications and stability requirements for their molecule and have delivered all required data as defined by the joint development program. Work plan. Although our formulation work exceeded their expectations, Merck has chosen not to move this particular preclinical asset forward into clinical development Given their other preclinical pipeline priorities. We have a great relationship with Merck.

Speaker 2

They remain impressed with our team and technology And we continue to explore other potential opportunities to work together. I would also note that even though this program is not progressing, There was a huge side benefit to our Xerotech program as a result of the Merck collaboration. One of the deliverables that needed to be achieved was a detailed validated plan and timeline for potential manufacturing scale up. As part of that planned development, the team worked incredibly hard within a very short time window To successfully complete our 1st manufacturing scale up engineering batch using our own biologic material, A huge step forward in our Zenerget program that can benefit all current and future collaborations. For Horizon, considerable progress has been made and work continues with formulation and optimization of the subcu version of Tepesa.

Speaker 2

We are very confident we will meet the agreed upon target product profile and deliver 3 months of positive real time stability. Once achieved, we will receive a $6,000,000 success payment from Horizon. We expect Horizon will soon thereafter Also inform us as to whether they will execute their license option and whether they plan to proceed with further development and potential commercialization. Since announcing the Regeneron collaboration in late March, Regeneron has already nominated the first two molecules in the platform program. We are well into formulation work on the first of the 2 molecules and expect to begin formulation work on the second very soon.

Speaker 2

As we reported previously, Regeneron also has the option to nominate additional molecules for formulation development. Each of our technology partnerships Highlight the unique value proposition of our proprietary CERAGEX and XERESOL formulation capabilities and their potential for long term value creation. Hopefully, as you've just heard, we have you take away that we have another great quarter And first half of twenty twenty three with each of the three pillars of our business continuing to perform through continued revenue growth, prudent allocation of resources and disciplined expense management, we expect to hit the cash flow breakeven point before year end. This milestone should demonstrate to our shareholders that we can be a growing, self sustaining biopharmaceutical company without the need for additional equity capital to fund our operations. I'll turn the call over to Steve for additional details on our Q2 financial performance.

Speaker 3

Thanks, Paul, and good morning, everyone. We had another great quarter driven by the continued growth of all three products both in net revenues and underlying market demand. Coupled with our disciplined cash management, we exited the 2nd quarter with an extremely healthy cash position and are on track to hit cash flow breakeven in the 4th quarter. For the Q2, total revenue was a record 38,000,000 representing a 50% increase over the same quarter last year. It's worth highlighting that this is the 3rd consecutive quarter of at least 50% revenue growth.

Speaker 3

Strong underlying patient demand for all three products, coupled with revenue from our collaboration partnerships drove this growth in total revenue. Let's start with RECORLEV We are excited by the momentum we are generating with this product. Recorlev net revenue was $7,200,000 for the 2nd quarter And $11,600,000 on a year to date basis. Compared to Q1 2023, net revenue increased by $2,700,000 This growth is the result of an increase in the number of patients on therapy growing 38% quarter over quarter. We expect these strong results to continue as we are generating high quality referrals and providing full service support to help patients start and stay on therapy.

Speaker 3

Gevo net revenue for the quarter was a record $15,600,000 representing a 36% increase compared to the same period last year. Year to date net revenue was $30,700,000 representing A 28% increase compared to last year. In the quarter, Chivo prescriptions topped 51,000 for the first time, A 50% increase compared to the same period in 2022. In the 2nd quarter, the total glucagon prescription Market grew 1% compared to the Q1. Notably, Chivo total prescriptions grew 12% in the same period, Ending the quarter with total retail market share of approximately 29%.

Speaker 3

Gevo continues to significantly outpace the market. Moving to KEVEYIS. KEVEYIS net revenue for the quarter was $14,100,000 representing a 10% increase compared to the same period last year. Year to date net revenue was $26,800,000 representing a 21% increase compared to the same period last year. This revenue growth was driven by an increase in the number of patients on KEVEYIS.

Speaker 3

This proves our strategy to continue to invest in KEVEYIS has been successful to date in defending against generic competition. We will continue to invest in KEVEYIS and XERIS Care Connections as they offer the best in class therapy and support for PPP patients. Looking ahead for the full year 2023, based on our overall year to date results and confidence in our products and technology partnership collaborations, We are raising the low end of our previously issued guidance, which as a reminder was 135,000,000 We are raising this low end to $145,000,000 which now takes our new total revenue guidance range from $145,000,000 to $165,000,000 Moving down the P and L, cost of goods sold in the 2nd quarter was $7,600,000 a 57% increase compared to the same quarter last year. This increase is mainly driven by higher sales. Research and development expenses were $6,100,000 for the quarter, a $2,400,000 increase compared to the same quarter last year.

Speaker 3

This increase is consistent with our comments from our guidance earlier this year. We continue to expect a modest year over year increase in R and D expenses In order to fund our Phase 2 Levothyroxine clinical trial, the completion of our RECORLEV OPTIX study and continued development work of our proprietary formulation science. Selling, general and administrative expenses were $37,600,000 for the quarter, a $4,700,000 increase compared to the same quarter last year. This increase was driven by an increase in personnel costs from last year's Q4 sales force expansion, Timing of marketing expenses and rent expenses related to the new lease that commenced in April. On a year to date basis, SG and A increased slightly by 3% compared to last year, which is again consistent with our previous Guidance that SG and A would be relatively flat for the year compared to 2022.

Speaker 3

Given our strong commercial performance to date And our revised outlook, as Paul previously mentioned, we are expanding our Chivo and Workorlev sales teams In the Q4, to build on our momentum, it's worth noting that this expansion has been factored into our revised year end cash guidance. We ended the quarter in a strong cash position. As of June 30, we had total cash of approximately $81,000,000 compared to $95,000,000 at March 31, 2023. We are executing on our strategy and as we mentioned previously, We expect cash utilization to moderate throughout the middle of 2023 until the Q4 when we expect to achieve cash flow breakeven. Based on our strong year to date performance, we are increasing the low end of our previously issued year end cash guidance, Which as a reminder was $45,000,000 We are raising this to $55,000,000 which takes our new year end cash guidance to $55,000,000 to $65,000,000 which results in a revised and improved full year cash utilization of $57,000,000 to $67,000,000 I'll now turn it over to the operator.

Speaker 3

Please open the line for questions. Thank you.

Operator

Thank We have our first question on the phone lines from Orion Levenat of H. C. Wainwright. You may proceed.

Speaker 4

Thanks. I have a few. On Gevo to start, I think we've seen some flattening of the share, I guess, since mid May. And I think that's a pattern we've seen every year since launch in the summer and into early September, some flattening or actually in prior even decline in share. Can you just Remind us what the dynamics are there and how confident you are, not just market growth going forward, but a reacceleration in September and beyond of market share.

Speaker 2

Hey, Oren. What you see is that little bit of seasonality. When we start to get into the back to school period, usually mostly July August, Our share doesn't accelerate as fast as Vaccimi, for example. Back to school is really a ped endo or pediatric endo business. And Lilly is or has been historically and still is Extremely strong in pediatric endo.

Speaker 2

So our business continues to increase. The sales of Gevo continue to increase, But the share capture doesn't slows a little bit. It's an annual phenomenon. You can see it every year for the last since launch.

Speaker 4

Is there any difference with Amphastar promoting this product now versus Lily, not just on their promotional or infrastructure side, but maybe on contracting. I noticed your Prescriptions were up 12% as you highlighted quarter over quarter. Sales were a little flatter. So is there any underlying change there? Or is that just noise quarter to quarter in terms of 1st semester inventory, please.

Speaker 2

It's noise quarter to quarter and we have seen we haven't seen any Commercial activity to speak of at all on Baximy. We actually are hoping that Amphastar Has a strong commercial effort to continue to accelerate market growth. Having both Lilly and Xeris in the game Early on was really important and we hope that that continues. But in no contracting activity at all.

Speaker 4

Okay. And just and I'll get in queue after this one again. But on KEVEYIS, you had record Sales were up 10% I think quarter over quarter despite I guess some of our anxieties about the presence of a generic in the market. I guess, how does that happen? What are you seeing with regards to any impact of a generic?

Speaker 4

And are you still expecting potentially a second entrant this year?

Speaker 2

I'll start with the second question first. Our planning scenario was we always expected From the get go, a second entry. We haven't seen one yet. We'll cross that bridge when we come to it. But our strategy has been The same as what we said we were going to do, our Care Connections is extremely important to our Physician customers, and very, very helpful to patients.

Speaker 2

And that's a big part of why we're able to continue to keep people On the branded product, physicians are willing to fight for brand, patients are willing to fight for brand because they get tremendous support in terms of Negotiating reimbursement, our patient assistance managers are constantly in touch with patients and Helping them with whatever their needs are. We have patient mentors, which are patients who have been on KEVEYIS for a long time, Helping patients who are new to KEVEYIS through their titration period, it's a very, very white glove hands on service. And we think that's had a great deal to do with our ability to maintain the business. We're also continuing to add patients. We're growing referrals and we're growing patients quarter over quarter.

Speaker 2

Obviously, if there are Generics in the future, will pricing erode a little? Yes. Might we lose some patients in the future? Yes. But As we've said, we're going to defend this business and continue to invest for as long as necessary.

Speaker 4

And if I may, just speaking of your white glove services per se, On the RECORLEV front, how is that hub working versus expectations on Not only getting RECORLEV patients on therapy from referral to paid therapy timeline wise Success rate wise, but also keeping them on that. I understand that a lot of you're still early in the launch, but some of these plans I understand Require recertification or reauthorization quite frequently for these expensive drugs. How's your experience been on Getting patients on and keeping them on drugs.

Speaker 2

It's been excellent. So once again, these are Rare disease products and it's a negotiation patient one patient at a time. So you're not getting contracted Formulary additions and things like that, if you were to compare The success rate that we have with getting patients approved for RECORLEV therapy, it's as high as you would see if you were in a normal Therapeutic category trying to get formulary access. We have tremendous success. We're getting great access.

Speaker 2

Denials are relatively low and we apply the similar care connections to recorlev that we have for KEVEYIS And keeping people on drug has been very successful. As you know, they have to titrate over Time and we kind of hand hold them through that process. There is a little bit of a correction in the Q1 of every year in terms of People getting reauthorization of their insurance, but that has not been an obstacle at all.

Speaker 4

All right. Thanks. I appreciate it. Congrats on a good quarter.

Speaker 2

Thank you. Thank you.

Operator

Your next question comes from David Amsellem of Piper Sandler.

Speaker 5

Hi, thanks. This is Skyler on for David. Two questions here. Can you speak to the typical patient that is Recorlev or more broadly the patient mix, particularly in terms of prior exposure to rosima ketoconazole? And in that vein, what does the payer It look like for those who want to use RECORLEV in the first line, are you hearing that payers are requiring patients to step through ketoconazole?

Speaker 5

Thanks.

Speaker 2

So the patient mix is not dominated by ketoconazole at all. We're getting patients from all over. We're getting post surgical de novo patients. So the first line therapy doesn't require a step through. That's what's really exciting about it.

Speaker 2

The fact that we're getting a lot of an increasing number of patients who are being referred to RECORLEV straight after surgery It's unusual this early in the game. And we're getting patients from all of the other branded products, including well and Some are coming from Keto, but it's not an outsized number at all.

Operator

We now have Glenn Santoglio of Jefferies. You may proceed.

Speaker 6

Yes. Thanks for taking my question. Paul, I just want to follow-up on a couple of points that you discussed. Obviously, a good quarter on Recorlev and Keveyis. But I wanted to dig into GVOC a little bit because It seems to suggest the IQVIA data seem to suggest that maybe revenues would have been a little bit higher than what they were, which I guess is sort of Just based on the script number and it kind of feels like a little bit of the same scenario from last quarter where you're maybe making a little bit less money on a per script basis.

Speaker 6

Could Could you just unpack that, the GVOC revenues a little bit and give us a better sense for what's happened on the script and pricing side?

Speaker 2

Yes, Glenn, that requires a little bit of math, which I'll turn over to Steve to answer.

Speaker 3

Yes, Glenn, good question. So, yes, I think if you just did the math and assume that the IQVIA data would Extrapolate to net revenues that would suggest that our Gevo revenues would be about $1,000,000 higher. I think what we saw again in the second quarter Was a further tightening of wholesaler channel inventory levels by about a half a week. It's not necessarily a bad thing that there's a tighter correlation I think between what's going on in the channel in terms of the inventory levels in the True demand that we see in the IQVIA data. So again that was a bit of a drag on net revenue.

Speaker 3

If you look at kind of historical averages over the last three years, It can go up a couple of weeks in terms of the inventory levels and down a couple of weeks. And The first half, it's been a bit of a drag on net revenue. But I would say, look, the underlying demand, the underlying patient demand is what's going to carry the day At the end of the day, and that continues to be really strong and that the inventory levels in the Channel should follow that, particularly in the Perfect.

Speaker 6

That makes sense.

Speaker 2

There's a back to school. No. Yes.

Speaker 6

Yes, perfect. All right. I appreciate that. Just two quick financial ones. With respect to the Horizon contract, Paul, you mentioned the $6,000,000 success payment that you're hopefully going to receive.

Speaker 6

Do you have any idea or when you're expecting to receive that? And I'm kind of curious if that any of that's embedded within this year's Steve, that I'm kind of curious if that any of that's embedded within this year's guidance.

Speaker 3

Yes. So Good question, Glenn. This is Steve. I'll take that one. So based on the work plan and our current progress, we Back to complete that work plan in the Q4.

Speaker 3

So yes, that is factored into our guidance both from a revenue and cash perspective.

Speaker 6

All right. And then last question on the cash flow, Steve. I mean, it's you mentioned a number of times how you expect to be a cash flow breakeven by The end of this year. And I just want to reconcile that based on the guidance that you're sort of putting out there, right? Because you generated $71,000,000 in revs in First half, which to hit the midpoint, you need to generate $84,000,000 in the second half, which is a nice step up, but it also feels like your expenses are going up.

Speaker 6

Obviously, with your revenues, you also mentioned that you're expanding the GVOC sales force by 20 reps, and you said you're expanding the Recorlev Sales force to 30, I'm not sure how many incremental additions there are. But just looking at The Walsham operations this quarter trying to forecast the incremental revenues in the back half with an anticipated increase in expenses. I'm just trying to reconcile all those data points and think about that path to cash flow breakeven by the end of this year and I'll stop there.

Speaker 3

Yes, good question. So as Paul mentioned, the expansion at least on the Gevoque side is very modest with the inside sales Expansion. So most of those folks, it's not as costly as an expansion as a traditional field expansion. We do have, as I just mentioned, the $6,000,000 from Horizon in our guidance as well in the 4th quarter. That certainly helps some other one timers.

Speaker 3

I would say, in general, our SG and A should be relatively flat year over year. We saw an increase in this quarter. Some of that was just timing of marketing expenses, just preparing for the back School push in the Q3 for Gevo, but on a year over year basis, it should be relatively flat. So I think that all kind of points to it and we feel again very confident about hitting cash flow breakeven in the 4th quarter, Very confident.

Speaker 6

Okay. Thanks for the details.

Operator

Thank you. We have a final question on the line from Rana Ruiz of SVB. You may proceed with your question.

Speaker 7

Hi, everybody. Good morning. This is Nick Gasik on for Roan Ruiz. Thanks for taking our question. Maybe first, maybe a bigger picture question.

Speaker 7

What are some of the pushes and pulls that was getting closer to the high end of your new guidance? Which of your commercial products that you think are most likely to drive you towards the higher end of this range? I have a quick follow-up.

Speaker 3

So, Nick, good morning, Nick. This is Steve. I'll take that one. So, one, I think it's been a pretty resilient first half for KEVEYIS in the face of generics. So that's given us increased confidence.

Speaker 3

And I think where we saw RECORLEV exiting Q2 also gave us Really good confidence in terms of raising that low end. So, GVOOC will continue to perform. That's been on our bag for nearly 4 years now. So we have pretty good confidence in how that will perform, particularly in the 2nd half, but I think what's happened with KEVEYIS and how resilient it's been in the first half of this year And the growing momentum with RECORLEV, getting those patients started and staying on therapy, It gives us confidence to raise the low end of the revenue range.

Speaker 7

Got it. That's very helpful. And just a quick follow-up on Gevo. Can you talk a little bit about pricing? Curious if you could share your outlook on Gross to net dynamics for the back half of the year and expect these to stay generally stable or potentially tick up or how should we think about Those dynamics for the back half?

Speaker 3

Yes. As I think even going back to the second half of last year, we've said that Gross to nets have stabilized. So we don't anticipate any uptick in the second half From a gross to net perspective at all.

Speaker 7

Got it. Very helpful. And if I may, one more question on Recorlev. How should we think about Growth in new patient additions into next year and maybe I know you mentioned this earlier, but What are you hearing from physicians in the field on the dose titration process? And how are patients doing on the drug overall?

Speaker 7

Could you talk a bit more about that?

Speaker 2

Hi, this is Paul. I'll take that one. Patients are doing very well. I think part of the reason that doctors are starting to get comfort starting patients' First line is because of the performance of the patients they've already put on the drug in terms of efficacy and low and manageable side effects. We expect patient acquisition referrals and patients on drug to continue to grow at a similar pace Going into the 4th quarter or the second half of the year and toward the end of the year, Yes, we're not going to really give any guidance for 2024 yet, but we expect continued momentum and we're seeing great response from physicians.

Speaker 7

Very helpful. Thanks, Paul.

Operator

Thank you. We now have another follow-up question from Oren Novaknath. Please go ahead.

Speaker 4

Thanks. A follow-up, just 2 real quickly. On KEVEYIS, is there any update on the patent front? And on levo, your guidance For data by first half next year sounds, I guess, a little faster than my than the conservative expectations you sort of Gave us before about how hard it is to find patients and sort of reiterated the challenge there. That 25% enrollment so far, are you running ahead of schedule Despite the screen failures that you do and expected to see, are things going a little faster?

Speaker 2

Thanks. I wouldn't say things are going faster. Screen failures are high as we anticipated because finding patients that are stable on Lebo for 3 months is proving to be what we anticipated as hard. We didn't know what we didn't know going into the study in terms of timing. So I think being conservative in terms of enrollment when we first started out in terms of What we anticipated and what we conveyed to you, adding a couple more sites, I think is going to help us to continue to push The enrollment, but I think the first half is still achievable.

Speaker 4

Correct. And on the other hand, can I ask Scott in front?

Speaker 2

Oh, the patent. We did have our as you know, there are several layers of appeal in the patent As we've discussed, you go through a direct appeal, then you go to an appeals board, and you have to get through all of that before you end up With the ability to potentially go to court, as we anticipated that appeal to the Patent Trade Appeals Panel, They upheld the examiner's decision. So the next step is Federal Circuit Court and that's where we're headed next.

Speaker 4

All right. Thanks for the update.

Operator

Thank you. I'd like to hand it back to Mr. Edick for some closing remarks.

Speaker 2

Thank you, operator. Thanks again to everybody for joining us today. We're very proud of what we're building here at Xeris to service our patients and our healthcare professional customers. I'm especially proud of our team's performance and all we've accomplished to date. 3 consecutive quarters of at least 50% revenue growth is not Something that a lot of companies can brag about today, and I'm excited for us to build on the first half of the year for the remainder of 2023.

Speaker 2

I also want to thank our many loyal investors who see the potential Xeris possesses and continue to support us as we build a special kind of company.

Operator

Thank you all for joining at Tandemzyme. Today's call with Zeries' Biopharma has now concluded. Please have a lovely rest of your day, and you may now disconnect your

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Earnings Conference Call
Xeris Biopharma Q2 2023
00:00 / 00:00
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