Xeris Pharmaceuticals at Leerink: Strategic Growth and Financial Discipline

On Monday, 10 March 2025, Xeris Pharmaceuticals (NASDAQ: XERS) presented at the Leerink Global Healthcare Conference 2025. The company, led by CEO John Shannon and CFO Steve Piper, emphasized its strategic focus on growth and financial discipline. While the firm reported positive developments, including achieving an adjusted EBITDA positive status, challenges such as generic competition for KEVEYIS were also discussed.

Key Takeaways

• Xeris anticipates over 30% revenue growth for 2025, driven by its three commercial products.
• The company achieved an adjusted EBITDA positive status, reflecting financial strength.
• A strong balance sheet and disciplined expense management are central to Xeris’s strategy.
• XP8121, a once-weekly treatment for hypothyroidism, is a key focus with blockbuster potential.
• Strategic collaborations continue, particularly in the development of high-volume subcutaneous injections.

Financial Results

• Revenue growth guidance of over 30% for the year.
• Gross margin profile exceeds 80%.
• Achieved adjusted EBITDA positive status, signaling financial health.
• Strong balance sheet with ample cash reserves.
• Consistent revenue expected from Xerajak/Xerosol partnerships.

Operational Updates

• Recorlev: Positioned for accelerated growth due to increased awareness of hypercortisolism.
• Gevoq: Steady growth with patent protection until 1936, focusing on 14 million unprotected diabetic patients.
• KEVEYIS: Resilient despite generic competition, supported by patient programs.
• XP8121: In planning with the FDA, targeting significant unmet needs in hypothyroidism.
• XeroJect and XeroSol: Ongoing partnerships and development of new assets.

Future Outlook

• Continued investment in high-value assets and XP8121 development.
• Focus on organic growth and strategic collaborations in metabolic/endocrinology.
• XP8121 has potential to address unmet medical needs, with updates expected mid-year.

Q&A Highlights

• Recorlev: Differentiated from generics, normalizes cortisol at the source.
• Gevoq: Aims to protect unprotected patients and increase market share.
• KEVEYIS: Efforts to find new patients and maintain revenue streams.
• XP8121: Targets patients with thyroid regulation issues, working with FDA for differentiation.
• XeroJect/XeroSol: Quietly continuing partnerships with consistent revenue expectations.

For a detailed understanding, readers are encouraged to refer to the full transcript.

Full transcript - Leerink Global Healthcare Conference 2025:

Rolana Ruiz, Senior Biotech Analyst, Leerink: Okay. Great. So welcome, everyone, to the Leerink Global Healthcare Conference. My name is Rolana Ruiz. I’m a senior biotech analyst here at Leerink.

And it’s my pleasure to introduce members of the Xeris team, John Shannon, CEO, and Steve Piper, CFO. So thanks for joining us.

Steve Piper, CFO, Xeris: Thanks for having us. Yeah.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yeah. So plan for today, I’ll start with bigger picture questions, and then we’ll drill down to more detailed questions over time. So maybe to kick it off and just for investors that are new or revisiting the XERRIS story, could you just recap your key focus areas and key differentiators going into 2025, particularly across your commercial portfolio and late stage pipeline?

John Shannon, CEO, Xeris: Okay. Thanks, Ron. For those that don’t know, XERIS, we’re a fast growing biopharmaceutical company. What’s unique about us is we have three commercial assets. We have Recorlev for endogenous Cushing’s, we have Gevo, which is for diabetics, a rescue med ready to use.

It’s basically an EpiPen for diabetics. And then we have an ultra rare product, KEVEYIS for periodic peripheral paralysis or PPP. All three of those are growing, fast growing. We just guided to over 30% growth for this year. And we also have a pipeline with our organically developed XP8121.

XP8121 is Phase III ready. We’re getting ready to move into Phase III with that. It’s for it’s a once weekly sub Q for hypothyroidism, which is a very large market and a great opportunity for us to build another asset. And what we showed in the end of last year is that we went adjusted EBITDA positive. So we are now in a unique position and a different company where we can truly fuel our priorities of growth, both of our commercial assets as well as our pipeline.

So we’re kind of turned that corner and ’25 is a transformational year for us to really start driving even more growth for shareholders.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. And thinking about next year and your strong performance, how are you going to balance commercial execution, pipeline advancement and financial discipline going forward?

John Shannon, CEO, Xeris: Yes. We said that when I came in as CEO back in August is that financial discipline is key. And there’s the guy keeping track of it, Steve, is for us to really invest in the assets that can drive the most value short term and long term. So those key assets are continuing to drive our revenue growth and driving it. We did 24% growth last year, driving it above 30% this year is our main objective.

So making those investments to do that and at the same time that’s generating enough income and cash that allows us to really start our future, which is eighty one-twenty one and start fueling that. So finding that balance and we continue to do that, we see that as this year as a great opportunity for us to continue that because we said once we go positive, we’re staying positive and we will this year.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. Got it. So you talked about key products, especially in the commercial front. Can you just walk us through your expectations into 2025 for Gevoque, Recorlev and Kyvias?

John Shannon, CEO, Xeris: Yes. All right. Well, I’ll start with Recorlev and maybe I’ll make Steve do some of these too. With Recorlev, the way we like to describe Recorlev, it’s the right product at the right time. The amount of excitement that’s going on in the marketplace as it relates to hypercortisolmia and the impact it’s having on identifying very stubborn diseases like diabetes or even stubborn hypertension, has really created a situation where more and more clinicians are testing and diagnosing people with hypercortisolmia and Cushing syndrome.

And like I said, there’s a lot of momentum in the marketplace in that space. And we have the right product. I mean, we think we have the best product. If you want to normalize cortisol levels and you want to get after the underlying cause of synthesis of cortisol, we have the ideal product to do that with Recorlev. So we’re in a unique market dynamic where we can take advantage of what’s going on in terms of tailwinds and really drive a lot of growth here.

We saw this coming early last year and by I don’t know, by August, we had doubled or added 50% to our sales force, and our patient services group. So as we saw this phenomena happening in the marketplace, we added resources and those resources are able to pay off very quickly at the back half of last year. So we started seeing some really accelerated growth for Recorlev at the back half of last year and we see that continuing into 2025 with the dynamics that are going on in the marketplace. So again, right product, right time with probably the best product out there for normalizing cortisol. I’ll go to Gevoq, maybe I’ll cover Gevoq.

Gevoq is our kind of early on it was our key product design with one of our technologies, aerosol technology. And it’s been a steady grower for us for now five years. And that marketplace is very unique. There’s 15,000,000 people either on insulin or sulfonylurea that should have a, they should have a rescue med just in case, just in case they go low. And it’s a very dangerous situation if you go low in those situations, and you don’t have a rescue med on hand, you know, bad things happen, you end up in the hospital or even potentially death.

So the guidelines have all been updated the last couple of years. And that basically said anybody on insulin or sulfonylurea should be protected in those situations and have a ready to use glucagon. So we’re helping to drive that. But right now there’s only about a million of those fifteen million people I talked about actually have a product in hand. So it’s really meant it’s changing medical practice from a standard of of care to a standard of practice in terms of getting clinicians to actually comply with the guidelines.

So our sales teams are out there doing that. There’s a lot of opportunity. We continue to grow that product fairly steadily. We see that now that that marketplace is kind of matured where the old standard kit chemistry kit is pretty much gone. There’s just a little bit of share left there.

It’s really bringing new people into the market and getting them protected just in case. So we continue to drive that growth. And we will always we drive the market growth. And then on top of that, we kind of capture a little bit of share. So we tend to grow better, a little stronger than the market in that situation.

And we’ll continue to invest in. We have a long runway on Gevoque. It’s got patent protection till 02/1936. We continue to just grind at continuing to grow that business. And then Kveias, maybe I’ll let Steve talk, take a break.

Steve Piper, CFO, Xeris: So Kveias, as John mentioned, is for an ultra rare population, PPP population. That product has faced generic competition since early twenty twenty three and has remained really resilient. And the reason why is because of all the support we give that patient community. And we see that that revenue stream, what that translates into from a revenue stream, has kind of remained relatively steady and we see that continuing into 2025 that maybe what we’ve seen in the last couple of quarters kind of reached a new level and we expect a nice steady contribution from KEVEYIS moving forward.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Sounds good. Great. So good overview. Maybe I’ll stick with Recorlev for a bit here. So how are you thinking about its overall safety and efficacy profile as it continues to differentiate itself versus generics and possibly other branded products like Korlym?

Like what are you hearing from prescribers today on that front?

John Shannon, CEO, Xeris: Yes. So like I said, I think it’s the right product at the right time. And so there’s a lot of talk about how do we manage hypercortisolemia. And so once somebody once it’s identified, then one of the key you want to get it down. And unique about Recorlev is its mechanism of action, where we block the synthesis of cortisol in like three different places.

So it’s kind of like, that’s why I say it’s the right product. It’s kind of a perfect little mechanism of action to bring down cortisol levels and normalize them. You know, Korlym blocks it in the tissue level and at the receptors. So the cortisol is still running around. So if the clinicians want to normalize cortisol at the source, then obviously Recorlev is a better choice.

And then the other player in there is Rekordati. And, you know, and again, there’s also blocks of synthesis, but it’s, you know, very hard and at the hand, it’s a kind of almost like a sledgehammer at the end. So I like to think we’re just right in that respect. Obviously, I’m a little biased, but in terms of that case, there’s a number of side effects that go on with hitting it too hard. So you want to find that right balance.

And I think that’s where Recorlev fits in very nicely from a mechanism of actions standpoint.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes, got it. And thinking about the recent revenue acceleration for Recorlev and just possible market expansion in the Cushing space, What are you thinking there? And how could that flow into the next couple of years growth for Recorlev?

John Shannon, CEO, Xeris: Yes. I think we’re very much in the early innings of where this market growth can go and come from. So as clinicians are looking at the various stubborn forms of diabetes or cardiovascular and other areas, they’re checking in and looking at cortisol levels. And it’s incredible what they’re finding is the number of people that are 1.8 times or 1.7 times above normal. And those scenarios are like, well, that’s what we need to go and start addressing.

And there’s been good data in that respect that’s not generated by us, but others that would say that that’s the right approach. And so I see that continuing for some time now.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it. Great. And switching gears to your other commercial product, Gevoque, I did want to ask a couple of questions. Maybe start with competition, landscape for Gevoque. Are you adapting any of your commercial strategies going forward?

Or could you talk about the strengths of your approach so far in driving steady growth for GVOC?

John Shannon, CEO, Xeris: Yes. I mean, we’ve always been focused on one thing and that is getting the people that are not protected, protected. So the fourteen million patients out there today do not have a ready to use glucagon, they need to get one. And that’s our story. That’s our message.

Our sales force has been focused on that and they’re hyper focused on it right now on helping the clinicians, the clinician office become more compliant with the guidelines. That’s a really important aspect of being able to so that it becomes more standard of practice every day that if you’re on insulin, you should have this. If you’re on a subvalonia urea, you should have this. So on how do you make the systems and everything work in the office so that that just automatically happens. And that’s what they’re focused on.

We’re not focused on the competition. We’re not focused on market share. The opportunity isn’t all those people that are not protected. That’s always been our focus, but we continue to really be more diligent in there. I would like to see the competition spending more time doing the same thing.

And so I think they’re starting to make some investments in this area, which would be great, because that’s really important that we get these patients protected.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. I hear you. And I guess as this is one of your more like long standing commercial products, are you seeing any shifts in the payer dynamic or patient adherence trends? And can you just remind us, is there any seasonality to the GVOC trends that we should watch out

John Shannon, CEO, Xeris: for? There’s always payer shifts. Every year, you’re battling with the payers to try to maintain and make sure patients have access to your meds. So there are games that go on every year with the PBMs and others. And so there you’ll see those shifts.

They normally normalize out by first quarter end of first quarter, mid within a few months, because there’s so many patients out there and there’s still such great access to these products, that you may shift from one contract to another. But you see a little bit of movement early on in the first half of the year, and like every year. In terms of seasonality, the seasonality for this product really is back to school time. And we always see a big pop of the entire market in late July, early August. And it’s usually over by mid September.

You see that big pop and then it normalizes for the fourth quarter and in the first quarter.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. Got it. And then third product, I want to talk about KEVEYIS. So it’s reporting continued steady revenues, which is impressive given some generics on the market. So could you just elaborate a bit on the retention strategies that you’ve been using?

You talked about high touch patient services as well. How could that keep sustaining Conveyus revenues? And how are you thinking about it going forward in the next couple of years?

Steve Piper, CFO, Xeris: Yes, I think, you know, we’re the ones relative to the generic competition going out there and finding new patients, right? That has been part of our strategy is we go out and find these patients. That’s not done at a prescriber level. That’s done by us. We identify those patients.

So that’s been a core part of our strategy. And then, what she mentioned is supporting those patients once they’re on therapy. You know, I think the patients see that. They understand that difference. And I think there’s always dynamics with pricing and reimbursement.

But as long as we can continue to identify new and retain existing patients, this product should hold pretty steady.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it. Great. So I’ll shift gears a little bit to the pipeline now. So one of the interesting future programs that I’m watching for is XB8121. That’s your once weekly, subcutaneously with thyroxine for hypothyroidism.

So maybe just to frame things, what are some of the catalysts coming up this year for that program? And how do you see this product fitting into the hypothyroidism market?

John Shannon, CEO, Xeris: So the catalyst is really we’re just in the planning mode and working out with the agency exactly what it’s going to take to get this product on the market, make sure that we can hit the real unmet medical need in this space, which I’ll talk about in a minute, and get to registration at some point. So as you know, there’s been no real innovation in this space for decades. And it’s probably the biggest drug class out there, thyroid replacement. So we’re in this unique situation where we’re and there’s no clinical data, like all the products are all old products based on DESE and bioequivalents. So we’re generating data around TSH and T4 and things like that, as well as demonstrating a real clinical improvement in these patients.

What’s unique about this is there’s a real unmet medical need in the people that cannot, the oral bioavailability just doesn’t allow them to get the product in their system, to get the drug in their system. So these people are constantly changing, moving, can’t, you know, trying to get their levels right. And it just doesn’t work by availability. People with celiac disease or people on proton pump inhibitors can’t really regulate these and get normal thyroid levels. So this is a real opportunity for us to meet a pretty significant marketplace where twenty percent of the patients out there, there’s twenty million people on thyroid meds and twenty percent of them just can’t get normal levels based on oral bioavailability.

And now you have a once weekly subcu that will allow them to be able to achieve what they’re trying to achieve. What was really interesting is when you talk to clinicians is they this is a real hassle. These patients are a real challenge for them, because they’re constantly trying to change meds, titrate all over the place in terms of how can I stabilize these patients on an oral therapy, and they can’t? So there’s a real opportunity there. So we have, the work that we’re doing this year is and you know, I get it all the time, why is it taking so long, is because it’s challenging and we’ve got to work through this for the first time.

We’re generating clinical data for the first time. We’re working with the agency. They’re working very carefully with us. We’re working in a narrow therapeutic window area, in terms of drug. And so and we’re working on a drug device combo in a once weekly subcu form.

Lot of kind of pieces to that. So we’re doing it in a planful way. We’ve been doing it in a working through the process with the agency in a stepwise fashion because the last thing I want to do is go into a Phase three trial with not the go to market type product. I want to be able to go into it, do it in a way that we can cover a large range of doses in a near therapeutic window that will be able to go right into Phase III and then into commercial. I don’t want to have to do some bridging studies later and things like that.

So we’re really taking a very planful approach to this and make sure we get it exactly right and make sure we have the right kind of label when we come out of there that we can really, kind of really make an impact in this marketplace.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes, I hear you. So talking about the FDA traction so far, what’s the FDA’s perspective been like on this program? And how do you plan to address some of the FDA’s feedback on things like dosing equivalents, etcetera, going forward?

John Shannon, CEO, Xeris: I think the dosing equivalents question is asked and answered pretty clearly, especially with what we saw. What we did in Phase one, then we did a pretty significant study with using PK population modeling. And then we confirmed all that in Phase two. So we hit the exact same dosing. So I think we know the dose and all that.

That’s really not the issue is how do you get how do you hit in a way that you can differentiate in a way in the marketplace, specifically with this population of patients that just can’t be treated, not treated very well at all with daily orals. So that’s really the focus there. And then how do you deliver it in this wide range of doses in a device, so that patients can easily do this at home. So that’s really the work and that’s where we’re having most of the dialogue with the agency.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it.

Steve Piper, CFO, Xeris: And I would just add to that, that the expectation is that we would provide a more fulsome update about the program mid year time frame. So in terms of catalyst, what are we looking for? What does Phase III look like? What does the market opportunity for this product? A more fulsome update mid year.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. You preempted my next question.

John Shannon, CEO, Xeris: I was

Rolana Ruiz, Senior Biotech Analyst, Leerink: going to ask you possible considerations, I’ll put it, for Phase three in terms of design, etcetera. Like what are you thinking about in terms of structure? I know it’s early days, but if you can share some ideas.

John Shannon, CEO, Xeris: I get that question all the time and we are thinking about everything and anything. We look at this as this has got blockbuster potential, like this could be a very big asset. And so we want to do it right. Like we literally want to approach this so that we can truly position this product to meet what is a very significant unmet medical need in the marketplace. So I don’t want to get into exactly how we’re going to do that.

But when we do talk to everybody like by mid year or so, we’ll be able to lay that out.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it. Okay. We’ll stay tuned.

John Shannon, CEO, Xeris: Yes.

Rolana Ruiz, Senior Biotech Analyst, Leerink: And then more of a big picture question, just wanted to check-in about the recent appointment of a new CMO. And how will this potentially help shape clinical strategy for you going forward, particularly for 08/2021 and some of the earlier XEROSOL programs?

John Shannon, CEO, Xeris: Yes. So obviously, Xerus is really turning to a different point in our lifecycle here and bringing in Ang when, Ang was with us years ago when we were developing Gevoque. He left for a while to do some other biotech stuff and move around. He’s got an unbelievable background. And it was great timing with the amount of work we want to do in the clinical space and the regulatory space with not only XB8121, but also with Recorilov.

There was a real great opportunity to bring him back and bring him in as CMO. And yes, he’s digging deep already. So it’s exciting to be able to bring someone back, bring someone who knows the company, knows the culture, knows what we’re trying to do, and has bought in and able to do that. So it’s just another sign of the work we have to do and the investments we want to make to really drive the growth of this company.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Sounds good. And then how do you think about different your balance sheet’s capabilities supporting the pipeline investments and possible BD going forward into 2025?

John Shannon, CEO, Xeris: I’ll let Steve talk.

Steve Piper, CFO, Xeris: Yes. So there’s a lot there. So one, what I’ve said last week is I think Xerus has never been financially stronger. We have a strong balance sheet, plenty of cash. We guided to 30% revenue growth over 30% revenue growth at the midpoint.

Gross margin profile in excess of 80% and growing. And we’re really being disciplined about our expenses. So particularly in 2025, that gives us a lot of flexibility to invest for growth as our top line continues to perform. So it gives us confidence that from a balance sheet perspective, we’ve got a lot of flexibility, a lot of optionality, I guess. As it relates to business development, I think when John took the role in August, we said, look, we’re always looking at business development opportunities, but going to be continue to be a little bit more disciplined about what we go after because we have such great opportunities with our own assets to drive value.

So that’s really the first priority for us out of the gate.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes. I hear you. And then I noticed you used to guide more on cash,

John Shannon, CEO, Xeris: and

Rolana Ruiz, Senior Biotech Analyst, Leerink: then now you’re guiding more on adjusted EBITDA going forward. So could you talk a little bit about that change? What motivated it? And some of your excitement behind that?

Steve Piper, CFO, Xeris: Yes. So having been at the company for eight years now, right, the company has been kind of a cash burn story to this point. When are you guys going to turn the corner? I think we’re turning the corner in 2025. And we felt like now is the right time to focus investors more on the strength of the P and L.

One, we have plenty of cash. I talked about the revenue growth at the midpoint of our guidance, strong margin profile and really being disciplined about our expenses. We felt like adjusted EBITDA was the right metric for the company at this point in its kind of evolution.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it. Okay. Makes sense. And then thinking forward as well, I wanted to ask a little bit about the Xeroject technology platform overall. Are there any milestones that we should watch out for in 2025?

And just what are your latest thoughts on large pharma partnerships and licensing opportunities?

John Shannon, CEO, Xeris: Yes. So, we continue to do work with our Xerajak platform as well as our Xeroxol platform. Both of them are great platforms for really advancing drugs in the space of if you want to get to a high volume sub Q injection, we can do that with both ZaraJak and even with Xeroxol. We continue to have these partnerships. What I guided everybody towards was what you saw the last couple of years is what you’ll see this year in terms of revenue, other revenue or our partner revenue.

We’re still doing work for that. We’re still bringing on new partners. We’re just not talking about it as much. And the partners are happy about that, because a lot of times they don’t want everybody knowing what’s going on there. And our primary reason is it’s out of our control.

What they’re doing, the work we’re doing, we generally get a specs or a target product profile, we develop that, we will prepare that for them. And then if they decide to take it into clinic or go anywhere, that’s up to them, right? So we continue that business, it’s still a very good business for us. And but we just if it’s something meaningful and it’s coming out, you’ll hear about it. But otherwise, just kind of think about it as steady kind of revenue in that space and what we’ve seen in the past couple of years.

And we’ll continue to do what we do for those partners probably just a little more quietly.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes, Gary. And I know a few minutes left. I just want to pause, see if anybody in the audience has any questions. Otherwise, I’ll keep rolling. Okay.

So maybe bigger picture, Zerozal, Sarajev, how how are you thinking of exploiting those technologies going forward in the next let’s zoom out like three to five years? I know you’re not making too many comments about partnerships, but what else are you thinking about in the background?

John Shannon, CEO, Xeris: Yes. So I mean start with XP8121, it’s a product of Xeroxol. It’s organically developed in house with our Xeroxol technology. And so I see it as twofold. One is, we continue to develop other assets for us down the road with the XeroCell or XeroJect for ZERUS.

And if they fit into that metabolic space or endocrinology, right, because that’s where our footprint is. That’s why another reason why I’m so excited about 08/2021 is because it fits right into where we’re going with Gevo and Recorlev, so we can commercialize ourselves. So an exciting opportunity for us. So I see that same thing with Zerosol and ZeroJek. So down the road, we can continue to invest in it.

At the same time, we can actually make a significant difference with other people’s assets and within those technologies, which is what we’re doing. So it is our future. It allows us to do everything we want to do going forward organically rather than have to go out and out license or use business development to continue to fuel future shareholder growth.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Got it. And then last question before we close out. Just is there anything you think investors are not appreciating right now across your story? You’ve got a lot going on. There’s a lot to look forward to this year.

What should we be thinking about going forward?

Steve Piper, CFO, Xeris: Yes. I think, one, I do think that Xerus is a really unique opportunity, investment opportunity. One, we have three commercial products that are growing very quickly and picking up steam actually going into 2025 and with a pipeline and a platform technology that underpins it all. So super unique and turning a corner financially this year sets us up really well. So I think there’s still room to grow from a shareholder perspective in terms of driving that value.

But I think there’s a lot to like about the story.

John Shannon, CEO, Xeris: Yes, just a lot of opportunity short term for shareholders as well as long term. So I want to really wanted people to see us in both those lights.

Rolana Ruiz, Senior Biotech Analyst, Leerink: Yes, makes sense. Well, we’ll stay tuned for more updates. And thanks again, John and Steve, for coming out with us here. Good to

John Shannon, CEO, Xeris: have you.

Steve Piper, CFO, Xeris: Thanks for having us.

John Shannon, CEO, Xeris: All right.

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