XERS - Xeris Biopharma Holdings Inc. (XERS) Q4 2022 Earnings Call Transcript

2023-03-08 10:56:05 ET

Xeris Biopharma Holdings, Inc. (XERS)

Q4 2022 Earnings Conference Call

March 8, 2023 8:30 A.M. ET

Company Participants

Allison Wey - Senior Vice President, Investor Relations, and Corporate Communications

Paul Edick - Chairman and Chief Executive Officer

Steve Pieper - Chief Financial Officer

Conference Call Participants

Oren Livnat - H.C. Wainwright

Roanna Ruiz - SVB Securities

David Amsellem - Piper Sandler

Presentation

Operator

Hello and welcome to the Xeris Biopharma Fourth Quarter and Year-End 2022 Conference Call. My name is Alex, and I will be coordinating the call today. [Operator Instructions]

I will now hand over to your host Allison Wey, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead.

Allison Wey

Thank you, Alex. Good morning and welcome to Xeris’ fourth quarter and full-year 2022 financial results conference call and webcast. 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 Edick, Chairman and CEO; and Steve Pieper, CFO. Paul will provide opening remarks, Steve will provide details on our financial results, and after a few closing remarks by Paul we will open the call for Q&A.

Before we begin, I would like to remind you that this call will contain forward-looking statements which may include but are not limited to statements concerning our business practices, 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.

Actual results may differ materially from those indicated by these forward-looking statements made during this call, as a result of various important factors, including our financial position and need for financing including to fund our product development programs or commercialization efforts.

Whether our products will achieve and maintain market acceptance, 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 complete successfully with existing and new drugs.

The effect of uncertainty is related to the impact COVID-19 on our business operations and clinical activities and our collaborators' ability to protect our intellectual property and proprietary technology, as well as other risk factors set forth in our filings with the Securities and Exchange Commission. Any forward looking statements in this call represent our views only as of the date of this call and should not be relied upon as representing our views as of any subsequent date. Subject to obligations under applicable law, we disclaim any obligations to update such statements.

I'll now turn the call over to Paul.

Paul Edick

Thank you, Allison. Good morning, everyone, and thank you for joining us today. Before highlighting our achievements for the quarter and full-year, I want to reiterate what we are building in Xeris. Everyone at Xeris is intensely focused on building a substantial patient centric, commercially focused, self-sustaining biopharmaceutical enterprise with multiple products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise, and increasingly value-added technology partnerships.

What you'll hear today is, we are continuing to progress very successfully on that journey. We are executing our vision. On to our key highlights. We ended 2022 with another record breaking quarters and full-year delivering net product revenue growth of 52% and 38% respectively on a pro forma basis. We finished the year with $110 million in total revenue and more than $120 million in cash on hand. Steve will provide more specific details on all of that.

We also advanced our levothyroxine pipeline program, added another high profile and potentially very valuable XeriJect program with Horizon, and prudently manage expenses and cash utilization. Our momentum carries into 2023 and sets the stage for what I believe will be the most meaningful period in our company's history, achieving cash flow breakeven in the fourth quarter without the need for additional capital to fund our operations.

I'll break down these achievements byproducts and programs starting with Gvoke. Gvoke had another record quarter and year in terms of net revenue and prescriptions. $15 million in net revenue, a 36% increase, compared to the fourth quarter of 2021 and an 8% increase from the third quarter of 2022.

For the full-year of 2022, Gvoke net revenues increased 35%, compared to 2021. Total prescriptions for the fourth quarter were over 41,000, growing more than 42% compared to the same period last year. Gvoke total prescriptions for the full-year were over 145,000, growing approximately 54%, compared to 2021.

The total glucagon market also grew 6% in the fourth quarter versus fourth quarter 2021. For the full-year 2022, the total glucagon market grew 9% versus 2021. And so far in January of 2023, market growth is back to double-digits with Gvoke continuing to outpace and drive market growth.

At the end of February, Gvoke’s market share of new prescriptions in the glucagon market grew to approximately 28%. Ready to use glucagon products now represent almost 75% of the total new prescription market for rescue glucagon. While more and more patients on insulin are getting ready to use glucagon such as Gvoke, there are still over 7 million who remain at high risk and don't have a ready to use Gvoke available, just in case.

To address this critical situation and motivate healthcare professionals, to do more, the ADA and Endo Society and other groups have recently updated their guidelines and include an important focus on the incorporation of ready to use glucagon into clinical practice.

For example, the Endo Society expanded the definition of those at high risk for a severe low and strongly recommends that ready to use glucagon should be prescribed for all patients with diabetes on insulin or sulfonylureas, confirming what we've been saying all along.

Moving on to Keveyis. Keveyis also had a record quarter and year, approximately $14 million for the quarter and just over $49 million for the full-year, which represent increases of 33% and 23% respectively on a pro forma basis. To date in 2023, we have not experienced negative impact on Keveyis from the first generic entry. That isn't to say there won't be an impact.

However, this is a challenging marketplace that requires significant work to identify patients and initiate therapy. We have yet to see how the generics may impact that process and the market as a whole. We will see how it plays out over the course of the year. That said, given the market dynamics historically, we are continuing to invest in Keveyis. Despite the entrance of a generic – and we believe we can maintain a considerable portion of the business we've worked so hard to build on behalf of the PPP community.

On to Recorlev. Recorlev is generating $3.8 million in net revenue for the fourth quarter, an increase of 51% from the third quarter. Total 2022 revenue for Recorlev was 7.4 million and that's only in about three quarters of patient referrals and initiations with minimal dose titration. This is totally in-line with our expectations for the early stages of the launch. Referral and initiation of therapy in Cushing's is a very deliberate process and since launch in mid first quarter of last year, we have steadily grown the number of patient referrals to Recorlev and we are continuing to steadily increase the number of patients started on therapy.

We are also starting to see many of those patients that started on therapy last year, begin to slowly titrate up their average daily dose. It's still very early in the launch, but Recorlev continues to grow nicely and continues to show great long-term growth potential.

Turning to our pipeline, and our partnered programs using our unique XeriSol and XeriJect technologies. For our internal development and eventual commercialization, our focus is on advancing the levothyroxine program. This program is the development of our small volume ready to use once weekly liquid formulation of levothyroxine for subcutaneous injection using our XeriSol technology.

As you will recall, last fall, we reported positive top line results from the Phase 1 pharmacokinetic comparison of oral Synthroid versus subcutaneous XP-8121 in healthy volunteers. As we discussed at the time, all of the data from that Phase 1 study were then combined to develop a population pharmacokinetic model. That model allowed us to perform simulations of various chronic dosing scenarios.

Based on comparable exposure at steady state, the model estimated that 1,200 micrograms of once weekly XP-8121 could provide similar exposure to 300 micrograms of daily oral Synthroid’s, implying a 4x conversion factor between once daily and once weekly. We presented these data at a Type C meeting with the FDA at the end of last year.

Based on the FDA's feedback, we will now initiate a Phase 2 study in subjects currently taking [oral Synthroid] [ph] replacement therapy to continue the dose conversion to once weekly – to confirm, excuse me, to confirm the dose conversion to once weekly XP-8121. We expect to begin that study by mid-2023. Data from this Phase 2 study will then inform our proposal to the FDA for a pivotal Phase 3 program.

Oral levothyroxine has been the standard of care for treatment of hypothyroidism for many years. And it continues and it is one of the most prescribed medicine in the United States generating more than 100 million prescriptions per year.

However, 49% of patients have some GI issue or comorbid GI condition impacting oral absorption. 21% take concomitant medications that could interfere with absorption and 17% of patients admit to compliance issues with the daily oral regimen. And many of whom may or may not be the same patient experiencing multiple issues. If we assume conservatively, that 62 million weekly doses per year is the addressable opportunity in that population that's having difficulties with the oral dosage.

At today's branded [indiscernible] cost, which is approximately $35 to $50 per weekly dose, that would equal a potential $2.2 billion to $3.0 billion market segment that would be our target opportunity, a very substantial opportunity for a once weekly drug.

In November, we announced a collaboration and option agreement with Horizon Therapeutics to use our proprietary formula technology XeriJect to develop an ultra-concentrated ready to use subcutaneous injectable version of TEPEZZA. Upon successful completion of the formulation development, Horizon will have an option to license the Xeris delivery technology for further clinical development and commercialization of TEPEZZA.

You may know that TEPEZZA is the first and only medicine approved in the U.S., approved by the U.S. Food and Drug Administration or FDA for the treatment of thyroid eye disease, which is a serious progressive and potentially vision threatening rare autoimmune disease. TEPEZZA in its IV form generated net sales of almost $2 billion worldwide in 2022.

To engage in the project to develop a subcutaneous form, we received an upfront payment from Horizon of $2.75 million in the fourth quarter and will be entitled to receive a payment of $6 million unsuccessful achievement of the target formulation. If the commercial option is then exercised by Horizon, Xeris would also be entitled to future development, regulatory, and sales based milestones and royalties based on future sales.

Moving on to our outlook for 2023. As I said at the start of this call, I believe this is a pivotal year for Xeris as we build on our 2022 momentum. Achieve cash flow breakeven in the fourth quarter and do that without the need for additional capital to fund operations.

We are positioned for continued growth and are providing the following 2023 guidance. We believe we can deliver total revenues of between $135 million and $165 million in 2023. This includes net product revenue from current commercial products, and other revenue from existing and potentially new technology collaborations.

The midpoint of this range implies approximately 36% growth from 2022. We expect the rate of cash utilization in 2023 to be significantly less than 2022. In 2023, we expect that to be in the range of $57 million to $77 million with the first quarter being the highest and improving considerably by the second half of the year, driven by our projected revenue growth and by aggressive cash management.

We expect year-end cash, cash equivalents, and short-term investments of between $45 million and $65 million. This guidance should give you confidence that our business is self-sustainable beyond 2023.

I'll turn the call to Steve for additional details of our 2022 performance and our 2023 guidance. Steve?

Steve Pieper

Thanks, Paul. Good morning, everyone. I will focus my remarks on a few of the key financial quarterly and full-year 2022 results and provide 2023 financial guidance, the details of which are in the press release issued this morning. Focusing on fourth quarter results, total net product revenue was a record $32.5 million, representing a 52% increase over the same quarter last year.

Strong underlying patient demand for both Gvoke and Keveyis and new patient starts on therapy for Recorlev drove total product revenue growth in the quarter. On a full-year basis, our total net product revenue was over 109 million finishing the year at the top-end of our most recent guidance of total net product revenue of $105 million to $110 million.

On a pro forma basis, total net product revenue grew 38% in 2022 versus 2021. This increase was driven by continuous growth in Gvoke and Keveyis and the launch of Recorlev in the first quarter of 2022. We are pleased by the performance across all of our products driving this growth.

Breaking it down by product, Gvoke net revenue for the quarter was a record 14.9 million, representing a 36% increase, compared to the same period last year. This increase in revenue was driven by continued growth in Gvoke prescriptions topping 41,000 for the first time more than a 42% increase, compared to the same period in 2021. This growth in demand was partially offset by a decrease in net pricing.

Consistent with prior years, the total glucagon prescription market declined in Q4 versus Q3, notably Gvoke total prescriptions grew 8% in the same period, significantly outpacing the market.

Full-year 2022, Gvoke net revenue was 52.5 million, representing a 35% increase compared to 2021. This increase was driven by a 54% growth in total prescriptions when compared to 2021, which was partially offset by a decrease in net pricing. As we mentioned last quarter, our net pricing has stabilized in the second half of 2022.

Moving to Keveyis. Keveyis net revenue for the quarter was 13.8 million, representing a 33% increase when compared to the same period last year. On a full-year basis, Keveyis net revenue was 49.3 million, representing a 23% increase, compared to 2021 on a pro forma basis. Revenue growth was driven by continued increases in the number of patients on Keveyis coupled with the net pricing increase.

Our commercial strategy on Keveyis since day 1 has been preparing ourselves for the possibility of losing orphan drug exclusivity status in August of 2022, and the potential entrance of generic competition. As we have discussed previously, we continue to seek patents to restore our exclusive rights.

In late 2022, the FDA approved the generic version of Keveyis. Our 2023 revenue guidance, which I will cover later in my remarks, assumes an impact of generic competition on Keveyis in 2023.

Moving to Recorlev. Recorlev net revenue for the quarter was 3.8 million, which represents a 51% increase over prior quarter and is a direct result of the steady growth of patients on therapy during Q4. Full-year Recorlev net revenue was 7.4 million. Given we are less than one-year in the launch, we continue to be pleased with our initial financial performance of Recorlev.

In addition to our total product revenue of 109 million, we generated $1 million of revenue from existing collaborations and partnerships for total revenue of 110 million in 2022. Looking ahead for the full-year 2023, we expect our total revenue to be in the range of 135 million to 165 million, reflecting combined Gvoke, Keveyis, and Recorlev net product revenue and other revenue from existing and potential collaborations and partnerships.

Other revenues in the year are expected to be episodic based upon our ability to attract new partners and successfully execute work plans, meet target product profiles, and/or achieve other development milestones on existing agreements.

Moving down the P&L, all of my remarks will be focused on full-year results. Cost of goods sold increased by 9.3 million for the year 2022, compared to 2021. The increase was mainly attributable to our sales growth. Research and development expenses decreased 4.2 million in 2022 when compared to 2021. The decrease was primarily a result of lower product development costs, driven by internal capital prioritization.

In 2023, we will continue to practice disciplined prioritization and we'll be funding our [levo] [ph] Phase 2 program, the completion of the Recorlev optics study, and continued development work on our proprietary formulation science. All of this will result in a projected modest year-over-year increase in R&D in 2023. Selling, general, and administrative expenses increased by 12 million in 2022 when compared to 2021. This increase was driven by the inclusion of a full-year of Keveyis’ commercial infrastructure and our 2022 financial results, which is not a change on a pro forma basis.

Recorlev commercial costs related to the products launched in 2022 and a previously communicated Gvoke sales expansion executed in the fourth quarter. The overall increase to SG&A was partially offset by lower Strongbridge acquisition related transaction and restructuring costs in 2022 when compared to 2021.

Looking ahead to 2023, even with the aforementioned sales force expansion in the fourth quarter of 2022, we expect total SG&A to be relatively flat in 2023 when compared to 2022. From a cash perspective, as of December 31, 2022, Xeris had total cash, cash equivalents, and short-term investments of 12 million, compared to 93 million at September 30, 2022.

Our year-end cash, cash equivalents and short-term investments exceeded the high-end of our previously issued cash guidance. As a reminder, the 122 million included a drawdown of the final $50 million tranche from the Hayfin debt facility and an upfront payment of 2.75 million from the Horizon Therapeutics collaboration and option agreement.

Cash utilized in operating activities improved over the course of 2022, supported by strong revenue growth from all three brands, disciplined expense management, and synergy realization after completing the Strongbridge integration. Cash utilization from operating activities, including restricted cash was 103 million in 2022.

In 2023, we project cash utilization from operating activities in the range of 57 million to 77 million. As we experienced last year, cash utilization in the first quarter is expected to be the highest quarter in 2023, driven by changes in working capital, including investments in inventory to support revenue growth. Cash utilization is expected to moderate through the middle of 2023 until the fourth quarter when we expect to achieve cash flow breakeven.

As noted, our SG&A expenses to be relatively flat to 2022 and are projecting a modest increase and R&D expenses for 2023, mainly driven by the programs we are funding that I previously mentioned. Considering our growing revenue and anticipated operating expenses in 2023, we expect our total cash, cash equivalents and short-term investments to end the year in the range of 45 million to 65 million meaning total cash utilized from operating activities for the year is expected to be in the range of 57 million to 77 million.

Assuming we are performing to our guidance, we project to reach cash flow breakeven in the fourth quarter of 2023, and from that point on, we will be a self-sustaining enterprise. I want to clarify for everyone what we mean by cash flow breakeven. Cash flow breakeven in its simplest terms means cash inflows will meet or exceed cash outflows. This will be further evidenced on our balance sheet.

We expect our cash, cash equivalents, and short-term investments balances at December 31, 2023 to be at or above our September 30, 2023 balances. Furthermore, and to reiterate our previous position, we do not plan to raise capital to fund our operations as we become a self-sustaining enterprise.

I will now turn the call back to Paul.

Paul Edick

Thanks, Steve. That's a picture of outstanding performance for the quarter and the year. And as I said at the beginning of our call, we are building a substantial patient centric, commercially focused, self-sustaining biopharma enterprise with multiple products in multiple therapeutic areas, a highly targeted development pipeline that has significant long-term promise and increasingly value-added technology partnerships and critically important to this journey is consistently meeting the needs of our patients and their caregivers.

What you heard today is confirmation that we are continuing to progress very successfully on that journey. We started 2023 building on our tremendous 2022 performance through continued revenue growth, careful allocation of resources, and prudent expense management. We expect 2023 to be a pivotal year for Xeris on that journey.

Now, operator, if you would please open the lines for questions.

Question-and-Answer Session

Operator

Thank you. [Operator Instructions] Our first question on first day comes from Oren Livnat from H.C. Wainwright. Your line is now open. Please go ahead.

Oren Livnat

Thanks. Congrats on executing across the board and the solid guidance. I have a few. On that guidance. I think that's a wider range than you've given in the past. And so, obviously, there's several moving parts. I was wondering if you could just talk about those – is this mostly giving a [wide berth] [ph] for potential Recorlev growth so early in the launch or the Keveyis generic impact uncertainty the biggest lever there up or down? And I have a follow-up. Thanks.

Paul Edick

Thanks, Oren. You're absolutely correct. It’s a wider range than normal. And yes, it's because there are a lot of moving parts. We're in the early stages of the Recorlev launch. How that goes is going to be yet to be determined. We've yet to see any real impact on Keveyis, but not to say there won't be some. And we don't know it's sitting here today, what that's going to look like.

That being said, the low-end of our range is still 30%, 32%-ish growth over prior year. So, at any point in the range, we're still growing really, really nicely.

Oren Livnat

Right. And I guess regarding Keveyis, to your understanding is there anything operationally for sale out there in the market at all at this point or is this just a theoretical threat that, you know, the [Torrent] [ph] or whoever's actually commercializing that has to really set up you know, infrastructure that doesn't even exist as far as you can tell? Is the doc even able to write or someone able to fill a generic prescription?

Paul Edick

Yes. So, so far, no. But we heard as recently as Friday that they now have the specialty pharmacy and are beginning to ship product to specialty pharmacy. Physicians have yet to be able to substitute. There hasn't been product in the chain. The one thing to keep in mind is, when you look at a Keveyis patient, we surround that patient with more than just a drug delivered from the pharmacy.

We have a group called the – our patient affairs managers that really spend a great deal of time with patients helping them through their drug initiation, their titration, if they have any side effects, they're there to call them on a regular basis. They help them with insurance. They help them navigate the pharmacy and make sure that they've got their drug and they get their prescription filled.

We have a group that are mentors and we have current Keveyis patients who spend time, hold hands with new Keveyis patients. And we have the specialty pharmacy that is one single pharmacy dedicated to their well-being. Interacts with their physicians on a regular basis.

So, until such time as a generic company sets up all of that, we believe patients will be inclined to take the time and energy and effort to appeal a generic mandate. And that's one of the reasons we think we can defend a considerable amount of this business. We'll see how that goes.

Oren Livnat

All right. You actually segued to my last one, and I appreciate it. [Multiple Speakers] Yeah, exactly. So that patient support and you mentioned, you know, walking them through initiation, titration, etcetera, on Recorlev, obviously, patient titration is an important part of that dynamic. And you mentioned, I think, some small uptick or beginning – patients beginning to [up-titrate] [ph] there, what are you seeing from existing patients, the earliest patients in terms of that trend in titration? And is that a process that you guys and your specialty pharmacy and your support hub or services are, sort of holding their hands or walking them and or their physicians through that process, or at this point, you really just have to hope doc’s once initiated are doing the follow-up, the monitoring and the titration?

Paul Edick

Yes. So, good question. It isn't a hope. Hope is not a really good strategy, but it is different. When you look at the clinical study, the clinical study was a very structured environment. Patients were brought back every couple of weeks and the titration was on a schedule. In the real world, physicians are starting at the lowest dose and they are managing the patients on the lowest possible dose throughout the process.

So, the titration is happening slower than you would have seen in the clinical study, but more or less what we had anticipated because physicians tend to like to start low and go slow because that's a prudent approach and we support that. So, in this situation, it's more in the hands of the physician than it is in our patient managers.

Our people do interact with the physician and we interact with them on behalf of the patient to make sure that they are going back to the test need to be monitored that they are at the right dose. When they get to the end of the month, the pharmacy says, you still want them on this dose, you want to titrate them just to make sure. So, there's interactions that help manage the patient, but it is a slower and more [painstakingly] [ph] process on the part of the physician.

Oren Livnat

Alright. Thanks. I'll get back in the queue. I appreciate it.

Operator

Thank you. Our next question comes from Roanna Ruiz from SVB Securities. Your line is now open. Please go ahead.

Roanna Ruiz

Great, thanks. Good morning, everyone. So, wanted to tag on to the 2023 guidance question earlier. I was curious, how large do you think the contribution might be from the other revenues piece that you described from partnerships and collaborations?

Paul Edick

That's a really good question. So, without us knowing, our partner Horizon made public the 2.75 million upfront and the potential $6 million payment on achievement of the target product profile. We don't know at this point, Roanna. Those two could fall in, you know both fall into 2023. It depends on how fast we go with hitting the target product profile and the formulation on a couple of others of these programs.

Some of them go really fast because it's easy to formulate and some of them we have to go through 3 or 4 cycles, sometimes 6 cycles of optimization. To really get to the right milligrams per milliliter. So, at this stage, it's hard to tell. As we do more of them and as we get more through the process, we'll be able to better guide you as to when some of those milestones might hit in the future.

Right now, and you have to understand, we've moved this whole process from what was with some companies way back when we were talking years ago. It was kind of like a science project, to now it's a real development project, and at some point here hopefully end of the year early next year we'll have a good line of sight on how that development project is going to play out in each one of these deals.

Roanna Ruiz

Okay, great. That's very helpful. And I wanted to ask a bit about Recorlev too. So, do you have any updates on your expectations for prescribing growth into the first half of 2023? And could it be impacted by possible deductible reset dynamics in the new calendar year?

Paul Edick

Yes, every rare and ultra rare product is impacted by deductible resets at the beginning of the year. As we've discussed in the past, with Keveyis for example, you see some what we call soft discontinued because they have to re-up their insurance at the beginning of every year. And those by and large all come back on to therapy after a little while. We're anticipating we'll see a similar dynamic with Recorlev because it's a rare disease.

They have to requalify and get insurance approved on a frequent basis actually. That's all factored into our guidance. It's all factored into what we believe the drug is going to do over time. We were well aware of that going in.

Roanna Ruiz

Yep. Makes sense. And last one for me. I was curious if you could give us any updates on payer coverage for Recorlev, like what ballpark proportion of patients seem to be having like very broad access, relatively low hurdles, things like that?

Paul Edick

The hurdles are all the same. Everybody goes through a prior authorization. I mean, that just is the case. And we are successful on behalf of the patient as often as we thought we would be. We win more than we lose. I wouldn't say, it's 80% or 90%, but it's definitely better than 50%.

Roanna Ruiz

Okay, great. Thanks for the help.

Paul Edick

And by the way, those that we lose, we oftentimes win on appeal. So, the patients never lost, lost, lost until they're really lost, lost, lost.

Roanna Ruiz

Got it. Thanks.

Operator

Thank you. [Operator Instructions] Our next question comes from David Amsellem from Piper Sandler. David, your line is now open. Please go ahead.

David Amsellem

Hey, thanks. So, just had a few. First, just going back to the guidance, I know it's a fairly wide range. You mentioned a lot of moving parts, but at the lower-end of the range, Paul, you talked about over 30% year-over-year growth. And I guess I'm just trying to get a sense of how you're thinking about Gvoke's role in that? Obviously, it's growing, but can you give us more granularity in terms of what you think the growth range could be here?

I know that there are some things in the marketplace that have changed with the kits being discontinued, but you also have the generic as well from Amphastar. So, just talk about the puts and takes on Gvoke and how aggressively you think that product can grow in 2023? That's number 1.

Number 2, wanted to pick your brain longer-term on Recorlev and ask you about competitive dynamics. As you know, Corcept has got their next generation cortisol modulator Relacorilant, and I'm just wondering to the extent that that product there is for – do you think that that could prove to be a headwind in any way for Recorlev? So, just talk about that longer-term.

And then lastly, just remind us when you think is the earliest you could file on the levothyroxine injectable product? Thank you.

Paul Edick

Okay. Let me start with Gvoke. We expect Gvoke to continue to grow very much like it has in the past. Right now, Gvoke is basically shouldering the majority of the market growth also. We're not seeing much activity from Lilly at all. So, especially – as the market growth continues to improve, Gvoke is going to continue to improve in terms of growth. I think we see it being growing as well in 2023 as it did in 2022. The Amphastar generic is having zero impact.

I have to tell you, we've had a couple of people bring that up on roadshow things. The legacy products continue to decline. If there's any impact of the generic kit, it's on the legacy kits. As Lilly discontinues theirs, [indiscernible] was deemphasizing theirs. The generics are kind of filling the void of what business still exists, but the new ready to use products are over 70% of the market now trending towards 75%.

Will the kits still maintain 10%, 15%, 20% over time? Maybe that's what legacy products tend to do in most categories, but it's not impacting us. We continue to grow, we continue to take share, and the market continues to show evidence of rebounding in terms of growth. In terms of Recorlev competitive dynamics, we're being very successful against everybody.

As you would anticipate, when you have a new drug in a rare disease category, especially one that looks like this with multiple players, the first order of business for physicians is to see how well we do. And they give us the [train recs] [ph].

I mean, literally people that they put on everything and it doesn't work, they give them to us. And we're proving that our patients on our drug do quite well. And then we start moving into other competitive products that our drug is a better option for. So, Korlym is a perfect example because the whole objective here is to normalize cortisol. Patients on that drug feel good, but it doesn't normalize cortisol.

And little by little, we're getting to a point where we're having – we're engaging in those conversations more and more with physicians in terms of – great if your patients feels good, but you're not really meeting the medical need and we'll start getting – we're starting to get some of those patients.

Whether or not they're a drug that's coming in a couple of years is going to be changed that dynamic. I don't know at this point. I don't think so, but we'll see. Recorlev, competitive dynamic, I think I handled that. Korlym, I think it handled that. And [levo] [ph]. So, we've said, we're going to start the Phase 2 study mid-year, by the time we complete that study, get data, it's a year later, we go to the FDA, then we got a Phase 3 program, which is a couple of years.

So, I think we're targeting somewhere in the 2026 to 2028 for that drug to hit the market. It's a wide range because we're at the beginning of Phase 2. We don't have a line of sight on Phase 3 yet.

David Amsellem

Helpful. Thank you.

Operator

Thank you. We have no further questions at this time. So, I'll hand back to Paul Edick for any further remarks.

Paul Edick

Okay. Thank you for joining the call this morning and for your continued support as we execute on our enterprise development strategy. I also want to personally thank all of our shareholders, our tremendous employees, the healthcare community, our patients and their caregivers for your patience, hard work, support, and continued belief in our mission. Have a great rest of your day.

Operator

Thank you for joining today's call. You may now disconnect your line.

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Xeris Biopharma Holdings, Inc. (XERS) Q4 2022 Earnings Call Transcript