Verona Pharma at Jefferies Conference: COPD Drug Exceeds Expectations

Published 04/06/2025, 20:06
Verona Pharma at Jefferies Conference: COPD Drug Exceeds Expectations

On Wednesday, 04 June 2025, Verona Pharma (NASDAQ:VRNA) presented at the Jefferies Global Healthcare Conference 2025, sharing significant progress with its COPD treatment, O2Ver. The company highlighted both promising sales figures and strategic expansions, while also addressing the challenges of market competition and patient adherence.

Key Takeaways

  • O2Ver’s launch has outperformed previous COPD drugs, with sales exceeding expectations.
  • Verona Pharma is expanding its sales force and leveraging direct-to-patient marketing.
  • The company is exploring new indications for ensifentrine and potential acquisitions.
  • Positive patient feedback is driving deeper prescribing patterns among physicians.
  • Verona maintains strong payer access, with most patients paying less than $10 out-of-pocket.

Financial Results

  • Q4 sales reached $37 million, while Q1 saw a significant increase to $71 million.
  • The company anticipates a gross-to-net adjustment settling in the mid to upper teens.
  • A 1% market share in the COPD space is valued at approximately $1 billion in sales.
  • Notably, 60% of Q1 dispensed prescriptions were refills, indicating strong patient adherence.

Operational Updates

  • Verona Pharma plans to add 30 new sales representatives by July 1, 2025, to boost prescription rates.
  • The company is targeting 45,000 physicians across 8,700 offices with direct-to-patient marketing strategies.
  • Enhanced patient communication services have achieved high consent rates of 80-85%, aiding in refill reminders.

Future Outlook

  • Verona aims to accelerate sales growth in the second half of 2025 through expanded sales and marketing efforts.
  • The company is investing future profits into pipeline programs, including Phase 2 studies for non-CF bronchiectasis.
  • Verona is considering acquisitions in the pulmonary/respiratory space to enhance its clinical and commercial capabilities.
  • There is potential for expanding ensifentrine’s indications to asthma, cystic fibrosis, and bronchiectasis.

Q&A Highlights

  • Physicians report positive feedback from patients using O2Ver, which is crucial for increased prescribing.
  • The current patient mix is evenly split between those on triple therapy and those on single or dual bronchodilators.
  • Verona emphasizes that O2Ver’s pharmacology complements rather than competes with biologics.

For more details, please refer to the full transcript below.

Full transcript - Jefferies Global Healthcare Conference 2025:

Andrew Tsai, Senior Biotech Analyst, Jefferies: We’re gonna get started with the next session. I’m Andrew Tsai, senior biotech analyst at Jefferies, and it’s my pleasure to have the Verona team with me. To my direct left, Chris Martin, CCO, and to his left, David Zaccardale, President and CEO. Welcome both of you. Thanks, Andrew.

Thanks. Maybe spend one or two minutes talking about the Verona story. I think a lot of people are familiar, but there are still people unfamiliar with your story. So maybe talk about what you’re working on milestones over the next six to twelve months. That would be helpful.

David Zaccardale, President and CEO, Verona Pharma: Sure. Sure. Happy to give a brief recap. I’m hopefully, everyone knows that Verona Pharma has asset, ensifentrine, which is a phosphodiesterase three and four inhibitor, commercially known as o two ver, which had, has been developed and looked at in a number of respiratory diseases, but has been progressed and now commercialized, for the maintenance treatment of COPD. We launched, o two ver in, the latter part of twenty twenty four, and, it has been going going extremely well, as we posted the first couple full quarters of the launch, for o two vera and COPD.

And and in many ways, as I’ve articulated, I think we’ll be, transformational, in the treatment of COPD and, fundamentally change how COPD is treated as we as we go forward, especially with the the additional new, products that are coming into the market for COPD in addition to o two ver. In addition, our pipeline contains two very important phase two programs, one in non CF bronchiectasis, which is a phase two study with an endpoint of exacerbation that is progressing and looking for a readout on it probably at the back end of twenty six, early ’20 ’7, as well as our combination product of glycopyrrolate, which is a LAMA, and ensifentrine as the first dual product that’s nebulized and really is a follow on from o two there. And we continue to progress that program in in in phase two. So we’re very pleased with not only the launch, which has been phenomenal, but also our progress on the development front.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Wonderful. So you’ve executed really nicely all this time. So people do put a lot of weight to what you say. And so when we last met in November in London last year, I think you hinted that you strongly believe this could be the strongest COPD launch in history. Is that still the case for you?

And are you willing to say this could be the strongest respiratory launch in history?

David Zaccardale, President and CEO, Verona Pharma: Yes. Well, I I think Chris can talk a little bit about it, but it already is, depending on how you wanna measure it or look at it. But if you look at some of the key, launches in in COPD, it definitely has exceeded all those launches, especially in the first two to three quarters by a large margin. And, you know, it it continues to progress as it should. It is a large market.

There are over eight million patients that are under maintenance treatment for COPD, sixteen million that are diagnosed in The US. Huge unmet need of patients remaining symptomatic on the current standard of care. And O2Ver as being able to be prescribed broadly in the indication across patients that are on single, dual, triple therapy as an add on. And we’re seeing incredible take up from physicians and interest and a lot of positive feedback. So this setup is extremely good and we’re very pleased with the progress to date and again continue to progress every day and we see a great future.

I think all of this revolves around again the pharmacology and that, you know, o two ver or ensifentrine is what I’d classify as a great drug in the sense of a compelling benefit to risk when you get lung function improvement, symptom improvement, exacerbation rate and risk reduction with a safety profile that’s favorable that is a compelling use case. And I think that’s what’s really driving it. And ultimately, we see it’s fitting into the treatment paradigm in a way that you’re able to use nonsteroidal anti inflammatories as a way to manage patients, which has not been available until now, especially through the inhaled route.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Okay. And to level set things, I think you’ve mentioned in the past 1% market share is $1,000,000,000 in sales. We now know your gross to net has been better than what you have expected. Maybe compliance is better than what you have expected. So is it still the case that 1% is 1,000,000,000 or could it be like 0.5% at this juncture?

David Zaccardale, President and CEO, Verona Pharma: Well, think the metric still is that as general rule, I think that’s where we want to say. I mean, yeah, a lot of things around persistency and refills per year and all of that which could change it is is a favorable to that 1% equal a billion. But I think it we’re very early in the launch, generally speaking, a couple three quarters in. And so I think it needs another several quarters in order to actually start to identify what is the persistency, what is the refill rate, and and the other metrics that it could affect that. But in either case, it’s incredibly favorable position to be in.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Understood. And I think I estimate so far as of first quarter, you’ve had twenty thousand to twenty one thousand patients on the drug? I could be off but let’s just say it’s around there. You did suggest sales of this drug is beating any other drug out there. Can you give us a sense of how many patients the best selling drugs did have at the same time point?

David Zaccardale, President and CEO, Verona Pharma: I don’t know.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Chris, you

David Zaccardale, President and CEO, Verona Pharma: want to comment?

Chris Martin, CCO, Verona Pharma: I mean, I don’t know. I don’t think I’d have to go back and look at in historicals. What I can talk about today is that, you know, when you look at what the potential of o two there could be, it’s as Dave talked about, there are drugs that have a profile that don’t look like o two there today. So there are drugs that have 22% patient share. There are drugs that have 13% patient share.

There are drugs that have 5% patient share. And those profiles of those drugs and molecules don’t look like what o two vera provides them. So, you know, instead of me kinda looking back at where they were, I think what what the those drugs tell me is the future of o two vera and what this peak could be is extraordinary. I think, you know, we have a drug that Dave described in o two vera that is a differentiated clinical profile. The bronchodilation and nonsteroidal benefits that o two vera provides these patients is something that what we heard in market research early before launch was desperately needed by the physicians.

You know, I think one of the underappreciated things from this launch story even early on was how much of an unmet need still existed in COPD. And when we walk into physician offices today, our physicians have constant complaints from patients that are dealing with daily dyspnea, daily decreasing activities, the inability to do things that you and I take for granted, and that has led to what we’re seeing in this uptake and what we believe the potential of this drug can be, especially as Dave described when you start inserting it before steroids and using it earlier and earlier in the treatment paradigm. So I think if I look at the future, there are drugs that have significant numbers of patients on them today that we believe our profile is very differentiated from.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. Okay. And so first full quarter sales $37,000,000 in Q4 then it went to $71,000,000 in Q1. We’re two months in to Q2. How do you think how do you feel about the shape of the curve?

Is it you know, linear or is it slowing down? Or can you give us some hinder hints?

David Zaccardale, President and CEO, Verona Pharma: Yeah. Not now, Andrew. But I I would say that as you’d expect, you know, we feel confident that the launch continues to progress if if in progress well. I think if you look at launch curves in the respiratory and COPD space, there is a level of linearity to it. Clearly, we can talk about the slope and slope changing, but that is the the shape of the curve that is most representative of of of sort of the field.

I think that speaks to a lot of the how physicians see patients, the cadence of patient care, how often patients come in, to see the physician, and that’s why you have that sort of, feel to it. Now it’s a dynamic process in the launch, especially this early phase because the the refill component, to a chronically administered, drug like o two there also starts to come into play, and and that’s some of the concepts we talked about, persistency, refills, number of refills. So we’re really focused on two fronts. One is making sure physicians are aware, educated, and that those patients that are applicable for O2VARE treatment, that we get new patients started on O2VARE. And of course, there’s millions of them.

In addition to that, it’s very important to look at refills and persistency, which again feedback from both physicians and patients is very favorable on O2 there. And I think we hear externally many people who do doc checks and everything else is consistent with that comment. So I think this what I just would characterize as a setup is extremely strong, and we need to continue to do the work.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Okay. I mean, sell side consensus is 92. It it is technically a slowdown. I mean, you’re you’re confident you would beat that number?

David Zaccardale, President and CEO, Verona Pharma: No, Andrew. Well, I would I would say that, you know, you we’re we’re we’re confident that the launch continues to progress and grow. So I I think you can do the math. You can do projections and and make your own understanding of what you what you think it is. It to us, you know, progress, constant expansion of prescribers, then depth of prescribing are all components to having a successful base that then then carries us into ’26 and ’27.

I would say also this is very early in the launch and where o two vera is being prescribed, would say a little bit more tactically and in a way where physicians are getting used to using it in their practice. Remember, doesn’t show up on day one and all become the standard of care at any and no drug does that in that way, especially in this space in COPD. So, I think I’m very excited about as we look into ’20 you know, the end of ’25, ’20 ’6, you know, and especially into ’27 as o two variant trenches itself more in the treatment paradigm where it becomes more of the standard use is is is the direction that we wanna take it. And I think that it’s a benefit to risk profile allows it to be used that way. And I think that’s a whole another level of integration and prescribing that’s different than what we see today as good as it is.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. Thanks. You know, when I did my own doctor discussion, some of them at the time of the launch wanted to prescribe this drug because it’s novel to a handful of the patients. And they told me, Andrew, call me back six months later because I don’t know if the drug is working across my patients. So what has been your kind of feedback on your side where well over six months in?

Yeah,

Chris Martin, CCO, Verona Pharma: Andrew, I think what we’re hearing from physicians is very positive feedback on what these patients experience. I mean, you hear anecdotal stories of things that patients are able to do again. But if I take a general theme that we hear our reps hear from physicians, the KOLs tell us, it’s just feel better. The drug makes me feel better. And if you think about what a COPD patient deals with on a day to day basis, they feel with they feel bad.

They they’re stuck to a couch. They’re not able to move. And for a doctor to hear themes of I feel better is is an empowering thing for them, especially in a field that’s seen no innovation for fifteen to twenty years. You know, I think I think when we think about this patient feedback back to the doctor, it’s an important aspect of getting greater depth of our prescribing. So we talk in our quarterly calls about the number of prescribers that have written for over 20 patients.

One of the things that we know that accelerates a doctor to go to 20 is patient feedback and hearing these patients tell them how they’re doing. Andrew, you mentioned something, a dynamic that just exists. Most docs don’t see their patient back next week. It takes them two, three, four months. So our team, the marketing team, our our patient services team have done a really nice job of developing ways where we can close that feedback loop back with the physician.

It can be simple marketing tactics, and it can be simple training that we do with the reps. When a doctor says, I haven’t seen it. I I don’t know how my patients are doing. You can ask a series of questions and quickly understand very quickly from that physician perspective how often they heard from that patient before o two there and how often they hear from them now. So I think that’s a dynamic that’s really important as we go for launch.

I think we’re very pleased by how we’re seeing this feedback come come out.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. And you mentioned the patient mix, so far still is 50% triples remaining on background singles, duals. How do you envision that mix to evolve into steady state?

Chris Martin, CCO, Verona Pharma: Yeah. If you think about this year, you know, this fiftyfifty split of on triple on on maybe double dual bronchodilator, single bronchodilator, I think it’s gonna be fairly consistent for this year. But the dynamic that Dave talked about, I I think you’ll see a shift potentially to more moderate patients, which is these patients on single bronchodilator or dual bronchodilators where you’re looking to avoid using ICS. It’s very clear in the guidelines where and when ICS should be used. Up until o two vera’s approval, there’s not been really a chance for them to properly administer that ICS.

Because when they have a patient in front of them, they’ve gotta help them, and they tend to just prescribe ICS. I think in the future, you’ll see some of that shift move a little bit more to the moderate patient, which puts you in front of ICS. You know, the one thing that I I think we’re very encouraged by is this fifty fifty mix early on is is probably a little bit sooner than we expected. Like, I think we expected most of our patients to be on background triple. But what I I think this early mix shows is and highlights the dynamic that both Dave and I are talking about, which is desire to use nonsteroidal anti inflammatories and broncho ilators earlier in the treatment paradigm to help these patients avoid some of the risks that are associated with ICS.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Makes sense. And so as we think about the twenty twenty five volume drivers, you mentioned breath, depth of prescribing, validation from patients that they’re feeling better immediately. Anything else that you would allude to help drive uptake further in terms of new patient starts, DTC ad sales rep increase, so forth?

Chris Martin, CCO, Verona Pharma: Yeah. There’s lot there. So let’s talk about we are expanding and adding 30 more reps. The genesis of adding those reps is based on data that we see. You you mentioned two things, which is new writers and depth of writing.

You know, based on nine months of launch, we see what it takes to get someone to write their first right to 20. And we believe that there’s an opportunity with these 30 reps to accelerate that momentum and add more new riders and increase the depth of prescribing of these physicians. So those reps are training right now. They will be in the field July 1. So we are active and ready to go with that.

I think that provides additional momentum as you think you’ve liked how the launch is going now. Imagine another 30 reps that are coming into the field in the next in the back half of the year. You know, the other side is our marketing teams have done a really nice job in what I would call direct to patient today. So we know we’re in 8,700 offices. They there’s about 45,000 physicians in these offices.

We can we can directly target patients that we know we’re interacting with in the office. And the marketing team has done a very nice job of doing targeted media, targeted advertising to supplement what our reps are doing. So I think that will continue through this year. You’ll continue to accelerate that. And then on the patient services side, you know, with the amount of data that we have, eighty to eighty five percent of our patients are consented.

That allows us to communicate to them. It allows us to give them information. It allows us to give them reminders. We are not reliant on a pharmacy to make sure a patient does a refill. So, you know, those type of tactics and initiatives, I think, are always growth drivers for the brand as you move not only through the rest of ’25, but in in the lifetime.

And allows a lot that’s part of the reason why we chose the channel and the distribution pathway is it gave us control in in communication and keeping these patients informed.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Got it. Got it. And then refill rates, can you remind us what the refill rates were in Q1 and how do you envision that mix relative to new starts to unfold by year end?

Chris Martin, CCO, Verona Pharma: In Q1, we said that 60% of our dispensed scripts, which was about we had about 25,000 dispensed scripts, 60% mix was a refill percentage. Eventually, this becomes a refill business. If you look at Trelegy today, the vast majority of their prescriptions are refills. So that’ll continue to creep up over the course of the time. If you look historically at COPD, COPD patients take about six fills a year.

It doesn’t mean they discontinue. It just means behaviorally they sometimes skip doses, they delay fills. And when we’ve modeled our launch, we’ve used that. But we’ve also said that we felt like there was an upside there. And the upside was based on two scenarios.

To one is we believe the drug provided a meaningful benefit that made patients feel better and ultimately wanting to take that drug. I think as Dave described in the KOL checks, that hypothesis appears true. The second thing is our distribution pathway. Owning the data, white glove service, we believe is different than what’s ever been seen in COPD and would allow for a differentiated persistency. Remember, we don’t have to go from six to eight fills to have a meaningful impact on the overall brand long term or patients.

Go from six to 6.5, it makes a big deal. So I would say with that 60% of our dispenses being refills that the early persistency is very encouraging to play out that upside. Dave mentioned earlier, we need a little bit more ends and time. You want a full year. We have more patients every month than we had the prior month.

So the ones that have had the most eligible refills are also our smallest ends. So I see. So more time, I think, will be able to provide more clarity. But we feel very comfortable the way the the curve is shaping on that.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And despite the small end for the initial batch of patients who started, at launch, is there are are they showing upside to the your estimate right now?

Chris Martin, CCO, Verona Pharma: I I think what we’ve said is we are very encouraged by that persistency. I think in in February, we also talked about patients having a significant number of refills already, and those are the smallest ends. So Mhmm. You know, I think we’re seeing really good early signs that the persistency can play out as the upside.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Got it. And so with all this said, I mean, I I just can’t help but think why can sales accelerate accelerate even stronger in second half? Can you maybe talk me down in my thinking?

David Zaccardale, President and CEO, Verona Pharma: Well, I mean, I’ll just a broad statement. Of course, that’s what we’re all endeavoring to continue to push to. I think as Chris mentioned, we are expanding the sales force based on information that we’ve received in the first part of the launch. You don’t add 30 people and maintain the curve. That’s not that’s not our intent.

So I think inherently you should we we should expect in the second half of the year, know, prescriptions, increased sales related to the additional sales reps. I I think, you know, like any other launch, there is a component that’s not directly under your control as, you know, peer to peer conversations continue on, speaker programs continue, education, forums, you know, eight we just came off of ATS. The presence in different ways all plays a role in it, and and I think that will will also, you know, be part of the story in the second half of of twenty twenty five. With that all said, you know, again, there there traditionally, and if you look at all the curves, there is a level of linearity to this growth. But, yeah, it is our, you know, intent to to maximize it to best of our ability and, of course, to to change the curve as we progress.

In any way you think about it, though, the setup is incredibly strong coming out of the first couple full quarters of launch. And when you are launching a drug with a compelling benefit to risk in a large market with high unmet need and great access, again, there’s nothing that really should slow that down.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Yep. And going back to gross to net, it came in better than your expectations in first quarter. Is it safe to assume it will not bounce back towards the 25% level originally from here?

David Zaccardale, President and CEO, Verona Pharma: Yeah. Think that, you know, it’s it’s early days on it, but at the same time we think there is growing stability around it. I I think as Mark Han has guided that, you know, somewhere in the mid to upper teens is is where we think it’ll settle out. Of course, we need more time, to really get a sense of that, and and that’s how we’ve been looking at it, and and expect it to be in that range.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Mhmm. And a couple of other housekeeping questions. Inventory, should we expect some build in Q2 or remain unchanged?

David Zaccardale, President and CEO, Verona Pharma: Well, it depends on how you want to look at it. I think contractually with specialty pharmacies, they’re to hold between two and three weeks of inventory. But when you have increasing dispenses and increasing patients, that two to three inventory by definition, two to three week inventory is more inventory because it has to support the growing patients and prescriptions. So it it inherently grows, but it’s still always tagged to it that’s two to three weeks, which I find to be, you know, very minimal in in the channel.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Mhmm. And on the payer access side, what is the success rate like? Is it close to a % essentially? Or how would you describe the payer success or payer access?

Chris Martin, CCO, Verona Pharma: Yeah. From a payer access standpoint, we we don’t have I it’s it’s not your classic, oh, I have a % access because on the Medicare side of the business, we have what I would classify as access. Like there’s no real prior auth step edits. They can get the drug. On the commercial Medicaid side, same scenario through those prior auths.

You know, the dilemma or the situation really comes out of out of pocket cost is why a patient may or may not fill a prescription. You know, on traditional Med B, eighty to eighty five percent of these patients have supplemental insurance, so that covers your your co pay. So those patients, in theory, pay $0. If you have Medicare Advantage, if they met their deductible, they pay $0. On the commercial Medicaid side, it’s low co pays because of the co pay card and the system that Medicaid is.

So if I look in totality, of all our dispensed scripts, about more than 80% of these patients have paid less than $10. So, you know, for the vast majority of these patients, we get very low co pays. And the other thing that’s nice is because of the way that we own the data, we’re able to go when a patient hasn’t met their deductible in January, we can always rerun their benefits at a different point in time in the year and help that patient navigate kind of their situation. Remember, COPD patients are not they have a lot of other health issues, so they go through their deductible over the course of the time. The channel and the distribution pathway allows us to manage and navigate that for them as well as they go through the year.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Right. And then maybe a slightly separate topic is maybe just remind investors one more time why you are superior to biologics out there. We had some major news recently.

David Zaccardale, President and CEO, Verona Pharma: Well, I’m not sure I would characterize superior to biologics. Let’s just call it completely different pharmacology. I think that our view on biologics is on one hand good for patients, and I think that developing nonsteroidal targeted anti inflammation is good. And we’re we think that that’s helpful for for patient care. Our view of it with o two vera is that it’s not competitive in any way, but more complementary.

The pharmacology is completely different. O2 varies a bronchodilator as well as a non steroidal anti inflammatory through the PD three, PD four pathway. And so, you know, I think that ultimately approaching COPD treatment in ways that you can use targeted non steroidal anti inflammatory approaches is good. And we’ll see how that all plays out in the coming years. But, you know, we we are very supportive of it conceptually.

We we think it’s helpful for patient care, and we don’t think it’s competitive with o two there.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Understood. And, you know, you’re gonna be generating a lot of cash this year already, profitable possibly or likely. What are you gonna do with all that cash?

David Zaccardale, President and CEO, Verona Pharma: Right. Right. So, you know, I think that it’s a good place to be. We will continue to, you know, invest in our pipeline programs and and making sure that those are properly funded. They are already through phase two, but it definitely supports us setting up into the further development of them as as we as we progress.

We’ll continue to lean in and make sure commercially we’re managing the launch optimally. So we will, you know, spend as as needed and and prudently in that area, but but also wanting to make sure we we maximize. So I I think we have plenty to invest internally currently. And and then, you know, we’ll see how we look as we roll through ’25 and into ’26. Clearly, there will be opportunities also to acquire assets.

And our our focus already is on assets that may be in the in the pulmonary respiratory space taking advantage of our clinical regulatory and commercial capabilities. All of that sets up extremely well by being profitable.

Andrew Tsai, Senior Biotech Analyst, Jefferies: And as we think about the potential other indication areas you can pursue with O2VAR, can you give us a teaser? What indications you might be thinking about and when we can learn more?

David Zaccardale, President and CEO, Verona Pharma: Yeah. Well, I mean, think you should look, you know, to our pipeline currently. I I think we’re very excited about bronchiectasis. So and a huge market, unmet need. I think that there’s plenty of opportunity there.

Clearly the use of ensifentrine can be done in other respiratory diseases, asthma for example, cystic fibrosis. All of those are different types of development programs, including larger programs, dose ranging studies. And so we need to look at that very carefully on the investment, the time, and the return. So we’re gonna stay very focused at least through ’25 on our current internal programs and making sure we advance them.

Andrew Tsai, Senior Biotech Analyst, Jefferies: Great. I think we’ll we’ll wrap it up there, but thank you for the updates. I feel really good about the launch. Thanks, everyone.

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