Q3 2024 Xeris Biopharma Holdings Inc Earnings Call
Hello, and welcome to the various Biopharma third quarter 2020 full financial results Conference call. My name is Harry and I'll be your operator today all lines.
We are currently in listen only mode and there will be an opportunity for Q&A. After management's prepared remarks, if you'd like to enter the queue for questions. Please dial star followed by one on your telephone keypad.
Speaker Change: I'd now like to hand, the conference over to Allison Wey Senior Vice President of Investor Relations and corporate communications. Thank you. Please go ahead.
Speaker Change: Thank you Harry.
Speaker Change: We appreciate you joining our third quarter results call today, I'm joined by John Shannon, Our CEO and Steve <unk>. Our CFO. This morning, we issued a press release with our detailed results, which can be found on our website. After our prepared remarks, we will open the line for questions before we begin I would like to remind you that this call will contain forward looking.
Speaker Change: Statements concerning the company's future expectations plans prospects and financial performance.
Speaker Change: Forward looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those forward looking statements for more information.
Nathan: Nathan on such risk please refer to our earnings release and risk factors included in our SEC filings any.
Nathan: Any forward looking statements in this call represent our views only as of the date of this call and subject to applicable law, we disclaim any obligations to update such statements. Let me now pass the call over to John.
John Shannon: Thanks, Alison and good morning, everyone I'm excited and proud to report another record breaking quarter with total revenue of over $54 million and product revenue of nearly $53 million led by strong demand of re coral LNG bulk.
John Shannon: Our product revenue growth of 27% Mark the 12th consecutive quarter of over 20% growth. That's right 12 quarters in a row of over 20% growth with the last two quarters accelerating to 26 and now 27% respectively.
John Shannon: The entire <unk> team is focused on driving growth and I'm, so proud to see them executing on all fronts.
John Shannon: In addition to our outstanding commercial success, we also significantly advanced our lead pipeline product <unk> hundred 21, our once weekly subcutaneous <unk> thyroxine and executed as planned on all of our technology partner programs.
Speaker Change: Over the last several months our primary focus has been executing the three strategic priorities I outlined back in August when I became CEO.
Speaker Change: As a reminder, these priorities are first the rapid and sustained growth of our commercial franchises.
Speaker Change: Enhancing our financial discipline, while ensuring we maintain a strong balance sheet to fund our strategic growth investments and third enhancing our communications and transparency with you our stakeholders.
So lets get in how we're doing starting with priority one.
I'm pleased to report another record quarter of product sales hallmark by the accelerating growth a record level.
Speaker Change: The ongoing rapid growth of <unk> and the continuing durability of our <unk> brand.
Speaker Change: Across all three products the commercial team continued to execute our plans, resulting in a 27% product revenue growth this quarter compared to Q3 last year.
Speaker Change: Looking specifically at each of our products.
Speaker Change: Yeah.
Speaker Change: In line with <unk> best in class profile, we saw a record number of new referrals in the third quarter. In addition, the team has been focused on ensuring the smoothest and most efficient process to support patients getting started on record level, which has driven a 126% increase in new patient starts compared to last year.
Our targeted commercial investments on recoil up or accelerating the growth of the recall of revenue to nearly $18 million.
Speaker Change: Up 119% over Q3, 'twenty, three and up 33% over last quarter.
Speaker Change: <unk> continues to have in our view our best in class profile for endogenous hyper cortisol EMEA and patients with Cushing syndrome for whom surgery is not an option.
Speaker Change: There has not been curative and.
Speaker Change: Endogenous Cushings syndrome is caused by chronic elevated cortisol exposure often the result of a benign tumor of the pituitary or adrenal gland. This is where we correlate it comes in and oral twice daily tablet that has been shown to normalized cortisol levels safely and effectively across multiple etiologies.
Speaker Change: Yes.
Speaker Change: As I mentioned in August the Cushing syndrome market place is expanding rapidly and creating strong tailwind for record level every day more and more people are being screened tested and ultimately diagnosed with hyper cortisol EMEA.
Speaker Change: Okay.
And recall as part of our disciplined and focused investment priority. We just increased the size of our record of sales and patient support teams by 50% in July to build on this momentum.
Speaker Change: And we expect that expansion to fuel continuing strong growth in the future.
Turning now to <unk>.
Speaker Change: This product continues to have enormous market potential given the overall population of people with diabetes, who are at risk for severe hypoglycemia.
Speaker Change: We are very pleased to see our efforts continuing to pay off in the third quarter <unk> achieved almost $23 million in revenue a 29% increase we saw a 20% increase in total prescriptions coming from an increase in new prescribers as well as an increasing number of repeat prescribers.
Speaker Change: Excitingly, we continue to steadily gained market share with our new prescription share now standing at 37%.
Speaker Change: Severe hypoglycemia can be life threatening.
Speaker Change: And requires prompt treatment with emergency glucagon <unk> medical intervention.
Speaker Change: The best way to ensure prime treatment is to have a filled prescription for a ready to use glucagon product and to carry that at all times Tivo is an easy to use reliable glucagon auto injector that patients can use swiftly at the onset of symptoms.
Speaker Change: Yes.
Speaker Change: We are just scratching the surface of the total addressable patient population of over 14 million people still on protective.
Speaker Change: And with patent protection to 2036, Jabil has a very long runway.
Speaker Change: Wrapping up the commercial execution is the durability of <unk> as a branded product.
Speaker Change: We are thrilled to have generated such strong support for <unk> in the medical and patient community and to see that translating to continued dedication to the brand.
Speaker Change: Despite the availability of generic competition, we believe <unk> is best in class surrounded by a tremendous support system that is valued by both the patient and the health care provider.
Speaker Change: In fact, while we're still early in the fourth quarter, we continue to find and support new PPP patients every week.
Speaker Change: Given our exceptional year to date performance and expectations for the remainder of the year I am excited to announce we are raising.
Speaker Change: Our revenue guidance to $1 $98 million to $202 million.
Speaker Change: Moving to our second strategic priority.
Speaker Change: Renewed commitment to financial discipline and execution of strategic growth investments, which enables the creation of short and long term value.
Speaker Change: Steve will go through our detailed financial results in just a bit so I'll just cover a few key highlights.
Speaker Change: We've made great strides with our financial profile are greater than 25% product revenue growth, our strong margin profile and our disciplined expense management all are contributing to a very healthy cash position of over $69 million in cash.
Speaker Change: This allows us to invest in the growth of our business with no need to conduct any dilutive financing.
Speaker Change: We anticipate that our fast growing commercial franchises will remain the core value driver along with the advancements and developed in our development stage pipeline led by XP 80 121.
Speaker Change: Yeah.
I can't stress this enough the more we evaluate clinical data and performed market research. The more excited we get owing to the overall size of the hypothyroidism market and in particular, the number of patients who are unable to control their hypothyroidism with oral therapy.
Speaker Change: Last week at the American Diabetes Association meeting, we presented data from our phase II study showing that 40% of the patients referred to the study as being in control were screened out of this study because they were out of normal range with.
Speaker Change: With positive phase II clinical data in hand, we initiated discussions with the FDA in preparation for our phase III Registrational program with XP $81 21.
Speaker Change: We have had favorable engagement and look forward to further interactions with the agency as we work through finalizing plans and timelines.
Speaker Change: We assess and determine the optimal path to registration, we expect to be able to provide a fulsome update in the first half of 2025.
Speaker Change: Yes.
Speaker Change: Just a brief mention of our technology partner programs. They are all progressing per each partnership agreement and we're actively working on potential new partnerships.
Speaker Change: Our current and potential partners recognize the unique features of our <unk> and <unk> technologies and the benefits our platforms may provide to their respective businesses.
Speaker Change: As our partnership programs advance and become more meaningful contributors to our business results, we will be sure to provide updates.
Speaker Change: Moving to our third strategic priority.
Speaker Change: We've been busy hearing from investors and getting your feedback I.
Speaker Change: I can personally share that I very much enjoyed digging into this role as the CEO and connecting with our Investor community all with the intention of increasing transparency and prove and improving the quality of our communications.
I was happy to hear that many of you recognize we have been executing and delivering meaningful growth with our current assets.
Speaker Change: We also understand you would like us to share more metrics that would provide a clearer picture of the long term health of our company and we're committed to providing even greater clarity as part of our 2025 guidance.
Speaker Change: Sure.
Speaker Change: Finally.
Speaker Change: The most exciting and consistent thing we heard was that almost all of your <unk> as a unique execution company with multiple fast growing products and a promising pipeline positioned well to create significant shareholder value in the short and long term.
Speaker Change: With that I'm going to hand, it over to Steve to review, our financial results for the quarter and year to date.
Steve: Thanks, John and good morning, everyone as John highlighted earlier, we are very pleased with our third quarter results and the positive momentum we are seeing with our business. We ended Q3 with net product revenue of $52 9 million in total revenue of $54 3 million.
Steve: Increasing by approximately 27% and 12% respectively compared to prior year.
Steve: This marks the 12th consecutive quarter with greater than 20% product revenue growth.
Steve: On a year to date basis net product revenue was $139 6 million in total revenue was 143 million, increasing by approximately 26% and 20% respectively compared to prior year.
Steve: Remember that last year in the third quarter, we recognized $6 million for achieving the pre specified target product profile milestone from horizon.
Steve: Excluding that nonrecurring item.
Steve: Total revenue increased by 28% and 26% for the quarter and year to date versus prior year.
Steve: Moving to our products.
Both more than doubling compared to prior year periods.
Steve: On a sequential basis, Percorla of Net Revenue increased by over $4 million compared to Q2.
Steve: For reference, last quarter, Record Love Net Revenue increased by $2.7 million compared to the first quarter.
Steve: This acceleration quarter-over-quarter is a result of our growing pipeline of referrals and our ability to convert them into more patients on Recoralev. We continue to see an increase in new patients, growing 25% versus Q2.
Steve: And we expect with the recently completed Record Lab commercial expansion that this momentum will continue.
Speaker Change: GVOC net revenue was $22.9 million for the quarter and $59.6 million on a year-to-date basis.
Speaker Change: representing a 29% and 23% increase compared to the same periods last year. This growth was primarily driven by an increase in total GVOC prescriptions.
Speaker Change: Consistent with prior years, GVOC maintained healthy growth in the back-to-school period. We are confident in GVOC's continued growth as new prescription market share has increased to over 37% as of the most recent weekly data.
Speaker Change: Kiveyas net revenue for the quarter and year to date was $12.2 million and $38.4 million respectively. In Q3, we saw a modest increase.
Speaker Change: in the number of patients on Coveas for the second quarter in a row as we continue to generate a strong pipeline of referrals.
Speaker Change: As a result of generic competitive pressure, pharmacy reimbursement has decreased, resulting in a modest negative impact to Cabeas Net pricing.
Speaker Change: Sitting here today, we continue to remain extremely confident in our ability to defend Cabezas against generic competition.
Speaker Change: Given the strong performance of all three of our products, and the momentum we are generating, we are raising our total revenue guidance to $198 to $202 million from the previous guidance of $190 to $200 million.
Moving on to cost of goods sold.
Speaker Change: Cost of goods sold as a percent of total product revenue increased to 25.7% and 19.6% in Q3 and on a year-to-date basis.
Speaker Change: Like many fast-growing biopharmaceutical companies, we are strategically implementing process changes with our CMOs to ensure we are able to increase capacity and maintain an adequate supply to meet the growing demand for our products.
Speaker Change: This quarter, we wrote off $3.6 million of GEVO components as a result of manufacturing process changes required to support ongoing capacity expansion efforts. It is worth noting that this charge had no impact to cash in the quarter.
Speaker Change: We are focused on ensuring we have adequate supply to support our fast-growing products and will continue to invest accordingly.
Research and development expenses were $5.9 million.
for the third quarter.
Speaker Change: Relatively flat compared to the third quarter of 2023, and were primarily comprised of costs for our pipeline, notably XP8121, and continued investment in our technology platforms and partnerships.
on a year-to-date basis.
Research and Development Expenses were $19.5 million.
a $3.5 million increase compared to prior year.
Speaker Change: which was primarily to support our pipeline increased personnel costs for the continued investment in our technology platforms and partnerships.
Speaker Change: Selling general and administrative expenses were $45 million and $123.3 million for the quarter and year-to-date, respectively, an increase of 21% and 14% compared to prior year.
Speaker Change: These increases were primarily driven by costs related to the previously announced CEO succession plan and related corporate restructuring, resulting in a one-time charge of $6.1 million in the third quarter.
Speaker Change: Excluding this non-recurring charge, SG&A only increased by 4% compared to Q3 of last year. This increase was driven by the expansion of our Recorla commercial organization.
Speaker Change: From a total operating expense perspective, we ended the quarter relatively flat to last quarter.
Speaker Change: When you exclude the non-routine charges of $9.7 million, which includes the CEO succession plan and related restructuring charges, as well as the GVOTE component write-off.
Speaker Change: We were able to keep these operating expenses relatively flat while generating approximately 14% in product revenue growth versus prior quarter
Speaker Change: Moving to cash. We ended the quarter in a strong cash position with over 69 million. Cash utilization has improved every quarter this year and we expect that trend to continue into Q4.
Speaker Change: Given our confidence in the health of the business, which considers our increased revenue guidance as well as the expenses associated with our Q3 ReCORLA commercial expansion.
Speaker Change: We are tightening our ending 2024 cash guidance to $68 to $72 million from $60 to $75 million.
We will continue to drive robust revenue growth.
maintain our strong margin profile, and diligently manage expenses.
Speaker Change: which gives us confidence that the business is financially sound and does not require any dilutive financing to fund our growth.
Speaker Change: Looking ahead to 2025, we will provide detailed financial guidance when we release our year-end results in March.
With that, Operator, please open the lines for questions.
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Speaker Change: Great, thank you Steve. If you would like to ask a question, please dial star followed by 1 on your telephone keypad now. If you change your mind and would like to exit the queue, please dial star followed by 2. And finally, when preparing to ask your question, please ensure that your phone is unmuted locally.
Speaker Change: Our first question today will be from the line of Chase Knickerbocker with Craig Hallam. Please go ahead, your line is open.
Thank you. Bye. Bye.
Speaker Change: Thank you for watching. Please subscribe to my channel. I hope to see you again soon.
Speaker Change: Good morning. Thanks for taking the questions and congrats on the, you know, really great quarter here. John, maybe just first,
Speaker Change: Help us think about kind of the specific drivers for record love and specifically, you know Obviously within your business kind of peel back the curtain a little bit for us on
Speaker Change: your team's execution. And can I talk a little bit about the pipeline kind of entering Q4, because seemingly this market has a really attractive growth profile from here. And I think investors can think that this inflection sort of continues. Just kind of speak to your confidence level there.
The End
Yeah, I think, um...
You know, I really kind of...
Speaker Change: Think about this as tailwinds in terms of the market growth and and and we're riding on that with You know a product that is Ricorla is a great product if you really want to normalize cortisol and inhibit cortisol production
Speaker Change: Right and maintain that so we're riding on that market expansion in that respect and our success is really driven by our team
of people out there identifying these people.
Speaker Change: with hypercortisolemia, who have Cushing's, as well as our patient access people who are, you know, really helping them get them started.
Speaker Change: So, as you hear in my script, and as we've talked a lot about, we're filling the top of the pipeline with referrals.
Speaker Change: and we're getting better and better at pulling those referrals into new patient starts. So those two aspects are 100% driven by our team and our support services out in the field.
Great, and then maybe to, go ahead, go ahead John.
John Shannon: Yeah, I should. So with respect to the pipeline in Q4, we're accelerating on both. So we've been, you know, like the top of that pipeline, or what we like to call the top of the funnel, is driving those referrals. And we continue to, you know, accelerate that level. We're accelerating at both ends.
So it's it's it's looking great
Great. And then, Steve.
Speaker Change: Maybe help us think a little bit about kind of the path to breakeven
Speaker Change: You know, you essentially guided to, you know, cash flow, break-even, positive, and Q4, kind of within that implied cash guidance. And as we kind of go into 25, as we kind of balance, you know, potential LIBO phase three program.
Speaker Change: and kind of the continued inflection you guys are showing in margins. Kind of walk us through how investors should think about your business getting to a cash flow break-even position on a go-forward basis, sustainably.
Speaker Change: Yeah, Chase, thanks for the question and appreciate you asking me to guide on 25. As I mentioned in my prepared remarks, we're not prepared to provide that 25 guidance yet.
Speaker Change: specifically with Levo. There's still work to be done there. FDA discussion is underway so you know we we expect to provide a more fulsome update in the first half of 25 and how that factors into our thinking for for 25 but
Speaker Change: I think you hit on something that, yeah, we're really confident in the trajectory of the business, particularly on the top line.
Speaker Change: coupled with a strong margin profile and, you know, in my prepared remarks I mentioned
Speaker Change: that our operating expenses were relatively flat when you back out a couple one-time charges in the quarter.
I think, you know, we see that path.
Speaker Change: and we'll provide more detailed guidance in March of next year. But we're sitting here feeling very confident about the financial profile of Xeris and where we're heading.
Thank you for watching!
Thanks guys.
Speaker Change: The next question will be from the line of Leyland Gershel with Oppenheimer. Please go ahead, your line is open.
Leyland Gershel: Hey, thanks for taking my question and great execution on another quarter here. Just a question on the P&L, the cost of goods seed even if after you back out
Leyland Gershel: that the 3.6 million from the GVOC write-off looks like the gross margin may have been a little bit lesser than it had been earlier this year. Just wondering if you can comment how we should think about that maybe through the fourth quarter and going forward. Thanks.
Speaker Change: Yeah I would say you know the the write-off in the third quarter was just the size of it was probably a little bit higher but I think as a
Speaker Change: You know, a biopharmaceutical company that has, you know, particularly with G-Voke, with the supply chain, you know, you have write-offs from time to time. We don't anticipate.
Speaker Change: Look, I think it's fair to assume that as we continue to sell more RecorLav...
Speaker Change: that should improve our overall gross margin. So, on balance, we look at it as healthy gross margins north of 80%, and we should continue to remain in that spot.
Thank you for watching!
Speaker Change: Got it. And John, I know that this would be clarity we'll be coming into on 81-21 as you continue with FDA discussions and we get into early next year, but just wondering if at this point, you could share just broad brush strokes of what you.
Speaker Change: Macy for pivotal for us the clinical trial for anyone 21. Thank you
John Shannon: Yeah, I'm not prepared to get into that because like I said, we're in we're in discussions and I and I and I and it's an iterative process in terms of, you know, kind of what we want to accomplish with.
John Shannon: This product in terms of, you know, things you want in the label things, you know, things like that. So I don't, I don't want to
John Shannon: I don't wanna give an opinion on any of that stuff right now.
Fair enough. Thanks for taking the questions.
Speaker Change: The next question today will be from the line of Oren Libnat with HC Wainwright. Please go ahead, your line is open.
The first time I've seen this, I've seen it.
Thank you.
Sorry, I just had to unmute there. Thank you.
Speaker Change: year-over-year and sequential growth. Are you, you know, maybe some of the pushes and pulls with regards to average dose versus growth to nets. I know there was a price increase in the July yet.
Speaker Change: Net sales were just slightly lower than the total patient growth year-over-year I'm just curious if that's just lumpiness in terms of timing of pull-through or payer dynamics and I have a follow-up
things like those, things like, you know.
in a state desert.
Speaker Change: Persistence and things like that are all still similar and same.
Speaker Change: What's really driving recorrelative growth right now is adding new patients at the top of the funnel and pulling them through to new patient starts.
Speaker Change: I can't emphasize that enough. That's the game right now. And that's where we're really having great success.
Speaker Change: Over time, some of those other things are going to move, but when you're adding new patients so quickly, Oren,
Speaker Change: You know, and physicians start low and go slow in terms of raising things up, dosing and things like that are going to take time to come up and that's fine. Our goal right now is to get the patients on and get them started, get them referred and get them started.
Thank you for watching!
Speaker Change: Okay, Ann, can you talk about the make-up between, oh go ahead, sorry. No, we're just not having any pay or pressure stuff, so.
So, it must be just timing of where...
Patient.
Speaker Change: Okay, and I think in the past you've talked about being pretty excited about things first line patients already.
Speaker Change: Can you just give us an update on the overall makeup of the patient base now between first line and switchers and for the latter, you know, what do you think the main reason patients would switch it on? I guess that is for both uncontrolled patients.
Speaker Change: more likely, but even maybe controlled patients, which is a larger portion of the overall Cushing's market, you know, it's possible that some of them might even switch over just given this approved therapy versus off-label keto.
Thank you.
So...
Speaker Change: I don't have the exact mix, but it's, you know, we get a lot of naive-to-drug new patients.
Speaker Change: And we're getting a lot of switches. So it's significant amongst both of them. I don't know the percentages exactly, but... So the reason we're getting them is if, especially on the new patients, if physicians really want to normalize cortisol,
and inhibit cortisol production, Recorliz is the best choice.
Speaker Change: If on these switches, it's usually they're not in control and they're switching to something else and they want to, you know, again, normalize cortisol and again, Recorla is, you know, the great choice there.
Thank you for watching!
All right, and on G Vogue, you know, you've talked
Speaker Change: at Ad Nauseam about, well, not Ad Nauseam, but you've continued to point out the underpenetration of the overall Google ad market, right? Why doesn't it look more like.
Speaker Change: EpiPen with this huge at-risk population, but it's not standard of care, clearly, yet.
Speaker Change: for these applications to get rescue. The overall market is probably, including old generics, probably in the low single digits now. And I'm just wondering, given that's in the guidelines now, what...
Speaker Change: Will it take and how long do you think it will take for this market to accelerate?
Speaker Change: So we start seeing more new, you know, new insulin or new at-risk patients through an existing one starting to get prescribed rescue therapy.
Speaker Change: Yeah, so let me start with where you started. It should be the standard of care just based on the guidelines.
Speaker Change: It should be the standard of care. What we're trying to do is make it the standard of practice for clinicians.
Speaker Change: and we're trying to drive that. We're the only ones doing it.
To be honest
Speaker Change: And so any growth in this marketplace is being driven by the Xeris team, by going into physicians' offices.
Speaker Change: Alerting them of the standard of care and getting them to change practice and make it part of their standard of practice.
That's the game we're out there for.
Speaker Change: and how long is it going to take, when is it going to pop? I don't have an answer for you, but what I can tell you is we have a long runway and a lot of time to get it done.
and we're going to work on this.
Speaker Change: until we run out of runway. And the GEVO team gets out there every day and really fights for the patients to make sure the ones that aren't protected are protected.
and that we'll continue to do that.
Speaker Change: So, you know, I don't know exactly how long, but we're in for the fight.
Thank you for watching!
Speaker Change: All right, just one last quick one. It sounds like you're planning to give some more detail and guidance for next year in March.
Speaker Change: Is that most likely just going to be a product breakout, hopefully, given a little more visibility on your
Speaker Change: Rick Horlev in particular, or can we also hope for maybe OPEX and Margin Guides as well?
Speaker Change: and John C. Wey. We've got a lot of, as I said in my remarks, we've talked to a lot of investors in the last 90 days.
Speaker Change: We got a lot of advice on what we need to report on, and we're taking all that into account and we will look at what are the key metrics.
Speaker Change: of our business going forward that we really should communicate so people can truly understand the value that we're creating for shareholders, not only short term but also long term.
Speaker Change: So, I'm not going to give you the exact measures, but I will tell you they'll be more and different.
Thank you.
Thank you very much.
Speaker Change: Great. I appreciate it. Look forward to it. Congrats on another great quarter. Thanks, Oren. Thanks, Oren.
Speaker Change: Our next question will be from the line of Roana Ruiz with Lear Inc. Partners. Please go ahead, your line is open.
Thank you.
Speaker Change: Hey, good morning. This is Nick Gassick on Furrowana. Thanks for taking our questions. Maybe first on RecorLabs. I'm curious what the outlook is on Salesforce expansion going forward and, you know, whether you'd continue to add more reps.
Speaker Change: from here and then could you also comment on you know how long it's taking physicians to titrate patients to stable doses in the real world and if any sense around where the doses land in relative to the maintenance dosing you looked at in clinical trials.
Thank you. Thank you.
Let me start with the last one.
Speaker Change: We're not at the at the doses and we've been really clear on that because clinicians are starting low and going slow. So we're definitely at lower dosing we're getting you know physicians are finding really really strong results in treating their patients.
Speaker Change: I don't know how long it will take to ever get...
Speaker Change: up to that level, but again, the reason it's gonna stay low for some period of time is because of the new patients we're bringing on. And again, they're coming in at low doses and being titrated up. So as long as our rates of...
Speaker Change: And what did we say, 126% increase in new starts? That's going to drive that number down. Keep that number where it's at for some period of time.
What was the other part of it? Expansion. Oh, expansion.
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Speaker Change: You know what? We had great foresight as we were looking at what's going on in the market and made two expansions over the last nine months.
Speaker Change: And in order to meet that demand. And I think we got it. I think we're in a good spot right now. So, but I can tell you that if if things continue to accelerate at levels that
You know even exceed our expectations
It's a good place for us to invest.
Speaker Change: in terms of driving the growth of this product and getting more and more people on RecordLab, which is really what that expansion would drive.
Speaker Change: Got it, that's helpful. And then for GVOC, any differences you saw this year in terms of the back-to-school dynamics relative to prior years?
Speaker Change: I think you mentioned having 37% of the market as of October, so I'm curious what your outlook is on gross to net for GVOOC in the coming quarters and whether you could continue to gross share from here into 2025. Thanks.
yeah I think there's I think that
Q3 was
Speaker Change: It's almost identical to every other Q3, the way things work, the way share moves.
Speaker Change: and we're back to gaining share again. Because as I said before, we're the ones out there driving the market growth.
Speaker Change: and with that growth, it's becoming share. The kits and the vaccine is not growing, share, not growing. So that's just us at this point right now. So,
Speaker Change: So I see that as again, how do we continue to do that and of course we're capturing all of that growth So we'll continue to you know, pick up share every quarter like we have been in the past
Speaker Change: Yeah, and then gross to net, I think, was your other question, Nick. You know, we continue to maintain, you know, our gross to nets, kind of where they've been over the last, you know, 12 to 18 months.
Speaker Change: It's always a trade-off of access versus discounting, and so we're pretty strategic about
Speaker Change: those decisions that we make to protect price, but also try to ensure patients have access to our products. So I would say just long-winded way of saying there we don't anticipate significant changes to our gross and that's looking ahead.
I hope that's helpful. Thanks.
Thanks for watching!
Thanks. As a reminder...
Speaker Change: My apologies. As a reminder, if you would like to ask any further questions, please dial star 1 on your telephone keypad now. And our next question will be from the line of David Amsalam with Hypersamba. Please go ahead, your line is open.
David Amsalam: Hey, thanks, and I joined late, so sorry if you had addressed these. Two questions. One.
David Amsalam: Can you just talk about how you're thinking about the trajectory of Cavaeus longer-term, just given the competitive landscape? So that's number one.
David Amsalam: High-level your thoughts about the sustainability of that that product and then number two just a big-picture question on On the cushion space, you know, we've seen a lot of acceleration and there's a crystal
David Amsalam: Sales, and there are, of course, other products that are in development, such as Relic Orland.
David Amsalam: You also have chronetics with an asset in development that's further downstream. But I guess the question here is, you know, how concerned are you about other modalities potentially creating more in the way of noise for record live longer term? Thanks.
The
Speaker Change: Yeah, let me answer Tovea's first, and I think we've said this the last two quarters. We have a lot of confidence in the durability of Tovea's, you know, and the way you...
Speaker Change: You look at this and measure when you've got generic competition is
Speaker Change: You know, can you continue to keep patience? Do patients come back?
to go generic and come back.
Speaker Change: and can you continue to find new patients and get them started on brand?
Speaker Change: So it's about patients and it's about, you know, what's being reimbursed at the pharmacy level.
and how that impacts.
Speaker Change: And what we've been saying for at least the last two quarters now is that we can keep the patients. And we're, you know, in some cases we're slightly growing the patients. So we're maintaining our patient base by, again, bringing on news and some people coming back.
Speaker Change: So we're maintaining at that level, getting some pressure on the price, which we saw in the numbers.
this quarter.
Speaker Change: The value of CAVEAS is all the support services around it.
Speaker Change: and that's deeply valued by not only the patients but the health care providers.
Speaker Change: And, and that's why we are, why this brand is being so durable. And, you know, we think it can be and continue to be durable. If more and more generics come out and, and come after it, you know,
Speaker Change: I don't know, but I can tell you right now that right now we're winning that fight on behalf of the patients.
Speaker Change: RecorLiv, I think all this activity in the space is good. I mean, I, you know, I, you know, you heard me refer to it as tailwinds. What's going on with respect to recognizing cortisol?
as
Speaker Change: a culprit in, you know, in things like resistant diabetes, in resistant obesity, in Cushing's.
Speaker Change: All of these areas are good for our recoil of brand.
Rekora Lev is in our opinion.
One of the best at inhibiting
Speaker Change: synthesis of cortisol and that's really the end game here is can you can you inhibit that cortisol levels And and and really help the patients and that really is will drive, you know, kind of managing the comorbidities of hypercortisolemia and Cushing's
Speaker Change: So, I think it's all good. Happy to have it. We benefit from it because it brings a lot more awareness to testing and that's a good spot for us.
Thank you very much.
Okay, appreciate it. Thank you.
Thanks, David.
Speaker Change: With no further questions on the line, I will now hand the call back to John Shannon for closing remarks.
Thank you.
Thank you.
Speaker Change: In closing, the entire Xeris team is executing on all fronts, resulting in another record quarter of revenue.
Speaker Change: Setting us up well for a very strong finish in 2024. In addition to our outstanding commercial success, we are also significantly advancing our lead pipeline product, XP8121, and executing as planned on all our technology partner programs.
Speaker Change: We are excited to be increasingly recognized as a unique biopharmaceutical company with multiple fast-growing products and a promising pipeline. I'm confident we are well positioned to create significant shareholder value in both the near and long term.
Thanks for being with us this morning.
Speaker Change: This will conclude the Xeris Biopharma third quarter 2024 financial results conference call. Thank you to everyone who was able to join us today. You may now disconnect your lines.