Paseer Biosciences at Jefferies: Strategic Growth Insights

On Wednesday, 04 June 2025, Paseer Biosciences (NASDAQ:PCRX) took center stage at the Jefferies Global Healthcare Conference 2025, outlining its strategic vision focused on non-opioid pain management therapies. CEO Frank Lee emphasized the company’s robust financial position and growth potential, while addressing challenges such as industry uncertainties. Key products like EXPAREL, ZILRETTA, and ioverao were highlighted as market leaders, with a significant focus on the recent EXPAREL settlement and its implications for future revenue.

Key Takeaways

• Paseer Biosciences aims to achieve its "five by 30" strategy, including treating over three million patients and expanding gross margins by five points by February 2030.
• The EXPAREL settlement ensures market exclusivity until February 2030, providing long-term revenue visibility.
• The company holds approximately $500 million in cash, bolstering its capacity for strategic initiatives and pipeline expansion.
• The No Pain Act is expected to drive growth through increased adoption by commercial payers and community centers.
• Paseer is exploring strategic partnerships to expand its geographic reach and product offerings.

Financial Results

• Paseer reported having half a billion dollars in cash, providing significant firepower for strategic initiatives.
• The company is targeting a 5% gross margin expansion by February 2030, supported by the transition to a larger manufacturing site in San Diego.
• Q1 gross margins were positive, although guidance remains unchanged due to industry uncertainties such as taxes and tariffs.
• The recent RDF litigation win eliminates low single-digit royalties on EXPAREL, further improving margins.

Operational Updates

• Paseer has established three separate sales forces for EXPAREL, ZILRETTA, and ioverao, enhancing its commercial, medical, and market access capabilities.
• The No Pain Act provides additional payment incentives for innovative products like EXPAREL, with smaller community centers adopting these policies more rapidly than larger institutions.
• The company is conducting a Phase 2 study for PCRX-201, a gene therapy asset for osteoarthritis of the knee, with results expected by the end of next year.

Future Outlook

• Paseer’s "five by 30" strategy includes achieving double-digit growth and developing five novel pipeline programs by February 2030.
• Strategic partnerships are a focus for expanding the company’s geographic reach and leveraging existing sales force capacity.
• PCRX-201 holds potential as a meaningful contributor to Paseer’s growth targets, with promising data on sustained benefits for osteoarthritis patients.

Q&A Highlights

• The EXPAREL settlement guarantees total exclusivity until February 2030, with limited generic market entry thereafter.
• The No Pain Act is anticipated to positively impact budgets and patient outcomes, supported by data from the IGOR registry.
• PCRX-201’s local delivery platform minimizes safety concerns, enhancing its potential for widespread adoption.

Readers are encouraged to refer to the full transcript for more in-depth insights into Paseer Biosciences’ strategic initiatives and future prospects.

Full transcript - Jefferies Global Healthcare Conference 2025:

Dennis Singh, Biotech Analyst, Jefferies: Hi, good morning. Welcome to the Jefferies Healthcare Conference in New York, day one. My name is Dennis Singh, biotech analyst here at Jefferies. I have the pleasure of having Paseer Biosciences CEO, Frank Lee, here with us. Welcome.

Frank, maybe to kind of kick things off, just give a brief overview of the company for those who aren’t familiar. Just talk about the business and, you know, how things have evolved over the last year or two.

Frank Lee, CEO, Paseer Biosciences: Thanks for the opportunity, Dennis. Great to be here. Vocera Biosciences, we’re a leader. We’re the leader in non opioid pain management therapies. And you might know our market leading products, EXPAREL, which is used for post operative pain.

It’s a market leader there. We have ZILRETTA, which is the only long acting FDA approved steroid that lasts for up to three months. And then we have ioverao, which is a device that uses a process called cryoneurolysis, freezing the nerve to provide immediate pain relief. So all three are market leading products. We’re in non opioid pain management therapies.

And these are the products that we have now. But we’re shifting our focus as well now to use some of the proceeds from these market leading products to invest in our pipeline going forward. We can talk more about that.

Dennis Singh, Biotech Analyst, Jefferies: Great. And, you know, a lot of investors are, you know, talking about EXPAREL and, you know, the settlement situation that happened recently. So, maybe help frame the settlement and how you view the settlement and how that kind of shapes the trajectory of the company over the next five, ten years.

Frank Lee, CEO, Paseer Biosciences: Yeah. First, let me talk a little bit about EXPAREL. I mean, it’s a wonderful product. I’ve known so many people now that have used it, and it helps. You know, think about this now.

When you have surgery, the first few days after surgery are the worst. And to the extent that you can mitigate some of that pain, all that pain without using opioids, that’s a big plus. And in fact, the government recognized that as well. And we’ll talk more about the No Pain Act that provides additional reimbursement. But that’s very, very important.

And so, for EXPAREL, there was a Paragraph IV challenge a few years ago, and that was an overhang on the stock for a while, as we all know. And as you might recall, last year, there was a ruling on the first patent. Of course, there are many patents that were disputed at that point in time, the first patent, and the ANDA approval. And so what we’re very pleased about is, you know, we took a very disciplined approach to getting certainty for the company because this is the market leading and lead product for the company. And in April, we announced a very positive settlement.

For those of you that know settlements, this one’s quite unique in the sense that it’s a volume limited settlement. So what that means is we have total exclusivity until 02/1930. And then between 2030 and 02/1939, there are different levels of market share that the generic is entitled to. So starting with high single digits, starting at 02/1930, that will go over the next four years until, let’s say, roughly a third, and that will climb to high 30s by 02/1939. So what that means is we have visibility on our market leading product for the next fourteen years.

And for the next five, we have total exclusivity in the marketplace. So we think that’s a very, very positive settlement, not only because of the certainty and visibility it provides, but it takes the overhang off the stock and it still provides substantial cash flows over the next fourteen years to reinvest in the pipeline.

Dennis Singh, Biotech Analyst, Jefferies: Male Right. And, you know, I guess in a most conservative case, one would assume that the generic competitor would achieve some of those max volume share outlined in the settlement. But that may not necessarily be your base case, right, in that, you know, even though it might be high single digits in 02/1930, they may not achieve that. So, maybe talk a little bit about your confidence around the competitor not getting to that limit.

Frank Lee, CEO, Paseer Biosciences: You know, what I really appreciate about the volume limited settlement is it’s clear how much volume each party will get. So there’s good discipline. We expect good discipline as we think about pricing. There’s really no incentive to drop the price to the floor when you already know what volume share you’re going to get. So we expect good pricing discipline.

And we expect to continue to grow the market. So as well as our broadly speaking share because if you think about this now, we’re very underpenetrated with this product, EXPAREL. And if you take a look at our TAM, it’s still in the high single digits. So we still see, I think, a good possibility here for not only good pricing discipline in that 2030 to 02/1939, but also expanding the market.

Dennis Singh, Biotech Analyst, Jefferies: Okay. And, you know, you mentioned pricing discipline multiple times. Like, what does that mean exactly? You know, are you talking about keeping price generally flat starting in 02/1930? Or there would be a little bit of erosion, but it’s just kind of modest year over year?

You know, it’s not like the typical generic pricing erosion that you would see normally?

Frank Lee, CEO, Paseer Biosciences: Yeah, it’s hard to predict, Dennis, at this point in time. What I will say is if you take a look at the traditional models, and we’re all aware of these traditional models, and there been a number of studies done, the first generic entrant in the classic non volume limited entry scenario, you might expect to see up to 15% price erosion. But this is very different. This is very different. There’s only one generic, number one, and it’s volume limited.

So I think that’s more on the more pessimistic side as we think about that kind of an assumption, given the volume limited scenario here as opposed to the open entry.

Dennis Singh, Biotech Analyst, Jefferies: Yeah. Okay. That’s very helpful. And if we can talk a little bit about no pain because that’s obviously going to be a tailwind for you guys. Remind us what that is and just whether or not you guys are seeing kind of early signs of the benefits of no pain in the first half of this year.

Frank Lee, CEO, Paseer Biosciences: Well, me set some context here. The company’s been around for a very long time, a recognized leader in this non opioid pain management space. And early on, the company recognized that these surgeries were leading to an epidemic. They were contributing to this epidemic of opioid abuse. And so working with patient advocacy, working with government stakeholders, physicians, patient advocacy, the company played a central role in getting this No Pain Act passed.

And what does it say? It basically says the following. Number one, pre no pain, These sorts of innovative medicines were all bundled inside one payment. So if you think about getting a knee replacement surgery, it didn’t matter what kind of drug you were provided for post operative pain. You just basically got one payment.

Okay? So there’s an incentive there to use, or let’s say a disincentive there to use, let’s say more innovative products that might be at higher cost or price. Although those products now will have downstream benefits of less opioid abuse, less ED visits, less side effects because of opioids. So there was a recognition of that. And so when the NOPAIN Act was passed and enacted starting January one of this year, what did it do?

Well, if you think about the 18,000,000 procedures a year that could qualify for, let’s say, a use of these kinds of drugs, about 6,000,000 of those are covered under CMS. Okay? And, you know, what CMS said is, look, in the outpatient setting, in addition to the bundled payment, we’ll provide an extra payment at average selling price plus 6% for innovative products like EXPAREL. And in fact, in the No Pain Act, there were 11 products that were approved under no pain. We have two of

Dennis Singh, Biotech Analyst, Jefferies: them,

Frank Lee, CEO, Paseer Biosciences: EXPAREL and ioverao. And so that’s what that is. So from the provider and institution perspective, they still get the bundled payment, which is good. But on top of that, to the extent now that patients are treated in the outpatient setting, HOPD, ASC, they will get the ASP plus six model, which many of you know from immunology, oncology, any place where physician administered products are used, you have an acquisition price, and you have the ASP plus six. So now it becomes perceived more as a financially beneficial argument directly in terms of the product itself.

And it also provides all the benefits that I talked about post, you know, leaving the hospital. Yeah. Or the ASC.

Dennis Singh, Biotech Analyst, Jefferies: Okay. And the no pain is only for CMS, right? So the six out of the 18,000,000 procedures. So in terms of the other 12,000,000, that’s non CMS, that’s more commercial?

Frank Lee, CEO, Paseer Biosciences: Yeah, yeah. It’s a good question, Dennis. So there’s always a mix. There’s always a mix here in terms of CMS patients and commercial patients. So commercial patients tend to be the majority.

Now what we’re really encouraged to see is commercial payers starting to come on board and starting to basically write policies that mimic the CMS policy, or better. And so this will take time. When we take a look at other market examples and analogs, first there’ll be a CMS ruling on the reimbursement. And then over time, it may take a year or two, you start to see commercial payers following suit. Now, what I’m very pleased about, and we’ll update you after the second quarter is done in our earnings call, is that we’re starting to see, I think, good traction here when it comes to commercial payers.

So we’ll be able to share that with you. We’ve been very pleased with how quickly commercial payers are coming on board. Now that said, and I’ve always said, and you can go back to the transcripts a year and a half ago, that based on our market research, it will take time for our customers to adopt no pain. And what we’re seeing now is the smaller customers, let’s say the community centers, community hospitals, small ASCs are adopting no pain. The larger hospitals, the larger IDNs will take more time to adopt, because you might imagine it’s a very complex system there.

And so that’s what we expect is that it’ll take some time. And we’ve always said probably around the second half of the year is when we’ll start to see some really meaningful uptake. That said, as we said in our first quarter earnings, we did see seven percent growth year over year on average daily sales because now there are different selling days, right, year over year versus last year. And typically we’ve been bumping around at about 3% or so prior to that. So that’s a good early sign.

Dennis Singh, Biotech Analyst, Jefferies: So how much of that do you think comes from some of these early no pain or no pain like tailwinds in Q1?

Frank Lee, CEO, Paseer Biosciences: JOSHUA Yeah. We’re definitely seeing that. We’re definitely seeing that. As I mentioned, where we see growth is in the smaller accounts where they can move quickly, more quickly. And we’re getting that feedback back from the field.

So I would say that, and now based on some improving commercial payer landscape, you might think about where there are geographic areas where a tipping point is starting to happen. And what do I mean by that? If you’re in a hospital and only, let’s say, a small proportion of your patients, commercial payer and CMS are covered, then you’re not going to change your practice. But if it’s CMS and a decent number of other commercial payers that represent now the majority, let’s say, of your knee replacement surgeries, now you’re going to change your practice, if that makes sense, right? So there’s a tipping point, and I think those tipping points will start to happen in various geographic areas as we start to see commercial payers come on board over time this year.

Dennis Singh, Biotech Analyst, Jefferies: In terms of EXPAREL, have you commented on the exposure to CMS versus non CMS in terms of percentage of revenue? I’m just trying to figure out, like, how levered are you to the CMS no pain situation versus the commercial side?

Frank Lee, CEO, Paseer Biosciences: Yeah. It’s roughly the split that we talked about, right? But let me just put some context around this is when Congress took a look at this and CMS took a look at this, what was very clear is that this is going to be budget neutral or better. Now think about that for a second, okay? Budget neutral or better.

And this is a situation where CMS is paying more, not less, because of that. So I really think that there’s an opportunity here not only to sustain no pain, but to broaden no pain, to not only outpatient setting, but also include the inpatient setting. I think there are opportunities in Medicaid as well, Because ultimately, this is good for patients. This is good for the health system. It’s good financially.

It’s good from a patient outcomes perspective. And if you’ve ever taken care of a patient who has just had knee surgery or knee replacement, shoulder surgery, etcetera, you will appreciate the fact that they’re not experiencing pain for the first three days, and they’re not on opioids. So I would talk to somebody who’s had some recent surgery about this. Because when people try EXPAREL, what they’ll tell you is, I’m not having surgery on the next knee without that thing. Okay?

Or some people will say, I had one without it, and I just had one somehow with it, and it was a world of difference. A world of difference. And I’ll tell you that we are mounting we are accelerating our efforts to collect data to support So we have the largest registry of its kind to look at knee surgery, knee replacement. It’s called IGOR, I G O R, all right? It it’ll have over 3,000 patients in it by the end of this year.

And it’ll continue to grow. And we’re working with our key accounts to collect additional information because we firmly believe that this No Pain Act is going to have a very positive impact on society, on our budgets, and on patient outcomes.

Dennis Singh, Biotech Analyst, Jefferies: Great. Maybe if I can ask a detailed question just specifically on gross margins, right? Like your guidance this year on gross margins does look a little bit conservative given what you guys have shown in Q1. Plus, I believe EXPAREL is or you guys will no longer be paying the low single digit royalties to RDF. So talk about like the pushes and pulls around gross margin guidance, if there’s any upside that we should be expecting later this year.

Frank Lee, CEO, Paseer Biosciences: So as you might recall, we rolled out our five by 30 path to growth starting early this year. And expanding gross margins by five points in this timeframe between now and 2030 is one of our key goals, at least put a stake in the ground. And we’re very thoughtful about that as we rolled out the five by 30, and we should talk about the rest of it as well. With respect to gross margin, first of all, we had a very positive first quarter. And I think that in terms of changing any guidance, we’re going to wait on that.

Obviously, there’s been a little bit of uncertainty in headlines as it relates to the life sciences industry in general about taxes, tariffs, and various other things. So, once that’s settled, think we’ll have better visibility. But what I am very pleased about are our progress against our five by 30 objective of five point expansion by 02/1930. What do I point to? Number one, as you mentioned, we won our RDF litigation.

And what that means is we no longer pay low single digit royalties on EXPAREL going forward, period. So that helps out of the game. Number two, as you may know, we have two manufacturing sites, one in Swindon, U. K. And the second one in La Jolla and San Diego.

And in San Diego, we’ve now completed the transition from 45 liters to 200 liter facility. And what that means is we’re going to be much more efficient. And so we further expect over this timeframe that we’re going to realize efficiencies on the margin because of that. And so that’s not even speaking to volume. And as we’ve always said, it’s really going to be the volume that drives the margins.

But even without the volume, what I’m telling you is the team has been working very hard to make sure that we can achieve or exceed that growth in margin.

Dennis Singh, Biotech Analyst, Jefferies: Okay. And we can take a step back. Mentioned your five by 30 and your 500 bp improvement in gross margins. But what are the other four components of the five by 30?

Frank Lee, CEO, Paseer Biosciences: Yeah. Thanks for that, Dennis. When we rolled that out, we had actually a very positive reaction from the investment community. You might recall back in January, we rolled this out at a different banks meeting, Dennis.

Dennis Singh, Biotech Analyst, Jefferies: No offense taken.

Frank Lee, CEO, Paseer Biosciences: Yeah. And so what are those five things? Those five things are number one, by 2030 we’re going have more than three million patients treated with our products. We’re sitting at about 2.4 right now. Second is we said we’re going to have double digit growth between now and 2030 and we’re well on our way.

We expect that come towards the end of this year we’ll be hitting that stride for all the reasons we talked about. Third is that we’re going to expand our gross margin by five points. We just talked about that. We’re well on our way because of not only the 45 to 200 liter transition, but also we won the case, which means no more low single digit royalty on EXPAREL. So that’s really focused on our current business.

What I’m also very excited about is what are we going to do about our future business? And so the last two relate to that. So by 02/1930, to have five novel programs in the pipeline, and we’ve already got a very good start to that, so we made an acquisition earlier this year of a company called GQ Bio, and we should talk about this. They have a very unique platform, and we have a lead asset in development, PCRX-two zero one. That’s the first product, first novel program out of five for osteoarthritis of the knee that were shared a number of times now.

Very compelling data. We’ll be sharing our three year data here shortly. So let’s talk about 02/2001 here in a second. And then finally, fifth one is around partnerships. Partnerships.

What do I mean by partnerships? Well, number one, you may not know it, but we only sell our products here in The U. S. So we have an opportunity with partners, not ourselves, by ourselves, with partners to realize the value of our products outside of The U. S.

So we’re in process now of engaging a number of potential partners to put that in place. Number two, we believe our products can be used very broadly across lots of different audiences here in The U. S. You talk about EXPAREL, talk about Xaretta and ioverao. These are products that could be used in a number of different settings, accounts, specialties.

And we believe there’s an opportunity there to have partners that expand our reach, okay, to go to places where we don’t go. We also now are open to partnerships as we think about balancing risk in the portfolio, and perhaps also in areas where our products, the know how there doesn’t exist inside the company but exists somewhere else. So we think there are both commercial and development partnerships that will count towards that five. So those are the five that we’ve outlined and we’re already making good progress against those five objectives that we have.

Dennis Singh, Biotech Analyst, Jefferies: Great. In terms of the geographical partnership piece, obviously, a partnership there and royalty CU would be highly accretive, right? So, can you just help us understand as it relates to EXPAREL, OUS, and things like that? Like, are some of the regulatory or reimbursement hurdles that may take place OUS?

Frank Lee, CEO, Paseer Biosciences: Yeah. From regulatory pathway, that’s not an issue. Our products are approved in most of the countries. It’s really a matter of making sure we’re very smart about which countries. Because as you know, the markets outside The U.

S. Are very different country by country. And my expectation here is it’s not all the countries, it’s a subset of countries in each major geographic region. And if you take a look at other non opioid pain, kind of broadly that therapeutic area, other companies as an example, you’ll note the kinds of markets that they’re in. So we think it’ll be an important opportunity.

It certainly won’t be the size of The U. S, but it’ll be an important opportunity with the right partners across major areas, recognizing, again, it won’t be all the countries, it’ll be some of the countries. So that’s number one. Number two, let me come back to that’s ex U. S.

In The U. S, I would look at partnerships in a couple different ways. Number one, we spent a lot of time and effort this past year to stand up three separate sales forces. Previously, we sold all three products under one sales force. Now what we’ve done is set up what we call commercial, medical, and market access powerhouse.

So now we’ve got three separate sales forces, one selling EXPAREL, one selling ZILRETTA, one selling ioverao. They have capacity to carry other products in the bag. So as we think about business development opportunities, we also look at those things that might fit neatly into the bag that could provide synergies. So as we know, selling two or three products is synergistic because these products work together to help each other product, okay, in the bag. So we’re open to that possibility as well.

So I’d look at partnerships in two different ways. Yeah.

Dennis Singh, Biotech Analyst, Jefferies: And in terms of overall capacity to do a partnership like that, at least in The U. S, like how much capacity do you have?

Frank Lee, CEO, Paseer Biosciences: Well, as I mentioned, we have just one product, I’d say just. These are important products. But we have second and third position available in these sales forces. And as I mentioned, it’s not just sales force, it’s also market access and medical. These are very, very important capabilities that we stood up this year.

Dennis Singh, Biotech Analyst, Jefferies: So, guess from capacity, I mean, in terms of how much additional debt or cash, you know, do you think you guys would need to do a

Frank Lee, CEO, Paseer Biosciences: Oh, I see. So the firepower, if you will, right? So we’re in a very strong position. We’ve got Sean here in the audience, our CFO. And you may know that we reported approximately half a billion in cash.

And we’ve got a convert coming due here later on the year. And we’re throwing off a fair amount of cash each year as well. So we’re not at all concerned about firepower. We have plenty of it, given the kinds of opportunities we’re looking at. So let me come back to we’re not going to be swinging for the fences here.

When we look at this market right now, there are, I would say, you know, disciplined ways to, you know, grab a hold of some of these products and put them in the bag, As well as now in the pipeline, we’re going to be looking for more de risked assets where our capabilities can add to the development of that product. And so again, I want to come back to we’re to take a very disciplined approach. We’re not going be swinging for the fences with huge acquisitions or new targets, etcetera.

Dennis Singh, Biotech Analyst, Jefferies: Okay. And then, you know, in the last few minutes, maybe we could talk about PCRX201. Just talk about, like, why that asset and, like, why do you have conviction around that asset and maybe the development path ahead in terms of clinical trials and things like that.

Frank Lee, CEO, Paseer Biosciences: Yeah, it’s good we’re ending with this because I have to tell you, when I first came on board as CEO about a year and a half ago, I did a portfolio review. And I said, Absolutely not. We’re not doing this. We’re not doing we’re not going for PCARX-two zero one. It’s gene therapy.

We don’t do gene therapy, period. And I’ve been involved in this industry for over thirty plus years. Gene cell therapy, monoclonal antibodies, small molecules, everything. What I saw in this one compelled me to change my mind. And what was that?

Number one, the data. We have 72 patients, and it’s very compelling data. Check our investor site, you’ll see a number of links. And what that says is instead of, you know, just a few months of relief, we’re talking about years of sustained benefit both in terms of pain and stiffness. And that’s not a placebo effect, okay?

Because we’ve looked at placebo effects, and it’s usually about two points on and it wanes over six months. What you see on this one is four points of benefit on Womack, and it’s sustained for two. And in fact, the three year data we’ll be presenting here shortly. So the data convinced me. And secondly, what I really like about this approach to gene therapy it’s really more of a, I would say, a delivery platform is it’s local.

All right? Think about that now. So this is local, it’s injected right into the knee, and it stays there, and that’s very favorable when you think about safety and adverse events, okay? So if you stand back from it, I really believe this could be the first gene therapy for the masses, for prevalent populations. Now, with an asterisk, which is we’re going to be administering this locally, we will not be infusing patients with this.

If you think about other joints of interest, other places where local administration could be useful, that’s going to be very, very important. So I’m excited about this. We’ve already started our phase two study that’ll read out end of next year. And so we’re very excited about this one because that one will include not only the active comparator, but also two other arms in terms of two other doses. And finally, when you take a look at this, this pathway is de risked.

There are two products already that are approved for this pathway, IL-one. All this is doing is providing some instructions for the body to do what it naturally does to produce more IL-one RA to block that pathway. And so the data demonstrates that.

Dennis Singh, Biotech Analyst, Jefferies: Okay. And in terms of actually filing for approval, what do you guys need? Do you need a real like a big phase three?

Frank Lee, CEO, Paseer Biosciences: Yeah, we’ll have to see. We’ll have to see. Because we have RMAT status, which is, as you all know, equivalent to breakthrough, similar in EMA as well. And we’ll have to stay close, and we will. We have that ability to do so.

We also we’re looking at other programs using this platform. So this platform, as you might think about, is more of a delivery vehicle for the instructions for the cell to produce whatever it wants to produce. And so we see a lot of potential here. So as we move forward, we’ll share with you some other ideas we have that came with the GQ Bio acquisition, in addition to now some really talented research folks.

Dennis Singh, Biotech Analyst, Jefferies: Male Okay. And last question. Do you see two zero one being meaningful being a meaningful contributor to your five by 30 target?

Frank Lee, CEO, Paseer Biosciences: Well, we do. And it’s clearly one of the novel programs for the pipeline. And based on the GQ Bio acquisition and the further potential of this platform, it could also, you know, add some more programs to that goal.

Dennis Singh, Biotech Analyst, Jefferies: Perfect. Well, that’s all the time that we have. Thank you so much, Frank, for joining us. And I hope you have a great day of meetings.

Frank Lee, CEO, Paseer Biosciences: Sure. Thanks, Dennis.

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