Q4 2024 Avadel Pharmaceuticals plc Earnings Call
Speaker Change: Greetings, and welcome to Avidel Pharmaceutical's fourth quarter and business update conference call.
Speaker Change: A question and answer session will follow the formal presentation. As a reminder, this conference is being recorded. It is now my pleasure to introduce Austin Murtaugh with PrecisionAQ. Thank you. You may begin.
Speaker Change: Good morning, and thank you for joining us on our conference call to discuss Avidel's fourth quarter and full year 2024 results. As a reminder, before we begin, the following presentation includes several matters that constitute forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Speaker Change: Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated by subsequent SEC filings.
Speaker Change: Except as required by law, Avidel undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events. Thank you for joining us on our conference call to discuss Avidel's fourth quarter and full year 2024 earnings.
Speaker Change: IH represents a significant opportunity for avid as we routinely hear that Lou mentioned its value proposition can potentially have an even greater impact in the IH community.
Speaker Change: This is primarily due to the deep sleep inertia IH patients face.
Speaker Change: Which makes it challenging to wake up in the middle of the night to take a second dose and to receive the full therapeutic benefit of a twice nightly treatment.
Speaker Change: The approximately 42000 diagnosed IH patients under the care physicians less than 10% are being treated by the only FDA approved treatment.
Speaker Change: Further underscoring the need for additional treatment options.
Speaker Change: In addition to our ongoing ice trials, we are continuing our work on a once nightly no or low sodium formulation.
Speaker Change: With a target product profile bio equivalent two remarks to maximize our competitive position in the market.
Speaker Change: Of what's at bedtime, no or low sodium formulation for potential appropriate octavate eligible patients would be an additional compelling treatment option.
Speaker Change: Would expand the patient population of those suffering with hypersomnia related disorders, who could benefit from our proprietary technology and our patient centric innovation.
Speaker Change: And lastly, we remain confident in our legal strategy relating to ongoing litigation.
Speaker Change: This includes the injunction case, which is pending the appellate court ruling.
Speaker Change: Antitrust case against <unk> that is currently scheduled for a jury trial in early November of this year.
Speaker Change: And our recently filed patent infringement suits, reflecting our actions to protect our novel once at Bedtime innovation.
Speaker Change: To wrap up we've made significant progress over the last 18 months and are very focused on these most important priority that we believe will deliver on the promise of lumens.
Speaker Change: We're proud to have the opportunity to reduce the burden of narcolepsy and help avoid octavate eligible people having to force if we wake up in the middle of the night night out.
Speaker Change: After night to treat a chronic condition using it twice nightly dosing regimen. The FDA stated is antithetical to the goal of improving sleep.
Tom: Now to translate our progress into our results and expectations, Let me turn it over to Tom.
Tom: Thanks, Greg before I begin. Please note that full financial results are available in the press release issued this morning and the 10-K.
Tom: I'll also be reviewing non-GAAP financial results, which can be found on our investor relations website at investors Dot Abdel Dot com.
Tom: Our final financial results for the fourth quarter and the full year and in line with the preliminary results provided at the beginning of January.
Tom: In the quarter ended December 31, 2024, we reported net revenue of $50 4 million and gross profit of $45 6 million.
Tom: Additionally, I'll note that gross profit includes an adjustment in cost of goods sold for a potential three 5% royalty on sales of Bloom rise related to the Delaware Court Memorandum, an opinion issued in September 2024 to.
Tom: To be clear while this matter is pending a final resolution it is a noncash expense.
Tom: A ruling from the Delaware Court pending and we intent we intend to appeal the final decision, but from an accounting standpoint, we have included a noncash accrual in cost of goods sold.
Tom: Turning to operating expenses.
Tom: We reported $48 9 million of GAAP operating expenses for the fourth quarter, which includes $5 1 million noncash charges comprised of stock based compensation of $4 1 million and depreciation and amortization of $1 million.
Tom: After adjusting for these items cash operating expenses were $43 8 million.
Tom: With respect to cash for the first time since <unk> was launched in June 2023.
Tom: The company was cash flow positive during the fourth quarter, resulting in an increase in cash of approximately $8 million and ending 2024 was $74 million of cash cash equivalents in marketable securities.
Tom: And lastly, a few comments on our path to sustainable operating breakeven.
Tom: During the fourth quarter GAAP operating loss was $3 3 million. However.
Tom: However, after adjusting for noncash operating expenses adjusted operating income calculated gross profit of $45 6 million minus cash operating expenses of $43 8 million was positive $1 8 million.
Tom: This marks the consecutive second consecutive quarter.
Tom: Positive adjusted operating income for the company.
Tom: Now Thanks, Martin remarks, with a few comments regarding our expectations for 2025.
Tom: Revenue is projected to be in the range of $240 million to $260 million, which at the midpoint represents a nearly 50% increase over 2024 and our patients on therapy will increase by nearly 40%.
Tom: Cash operating expenses for 2025 are expected to be in the range of $180 million to $200 million and importantly.
Tom: With a highly leveraged cost structure.
Tom: Cash flow for 2025 is projected to be in the range of $20 million to $40 million and that we can fund the ongoing launch in phase III study.
Tom: Our cash on hand, and expected cash flow from operations.
Finally, just a brief comment on Q1.
Tom: At this point, we are two thirds of the way through the first quarter and based on what we are seeing the early trends developing Q1 across key metrics are tracking in line with our internal expectations to deliver significant year over year revenue growth.
Tom: And achieve the full year guidance.
Speaker Change: We are encouraged by these developing trends and as Greg noted, we expect to see this translate into improvements in revenue in the second quarter.
Gregg: With that I will turn the call back to Gregg for closing remarks.
Gregg: Thank you Tom before we open the floor for Q&A, I'll summarize where <unk> stands today.
Gregg: We started 2025 with positive momentum as we continue to make progress during Q1 across our key patient metrics.
Gregg: We are investing strategically to accelerate launched execution throughout all of 2025 and beyond which positions us for a cash flow positive 2025, while making important progress in maximizing the full potential of numerous.
Gregg: Our lifecycle management programs are advancing with the goal of expanding the occupant market opportunity significantly and.
Gregg: And all of this is supported by a robust and growing intellectual property portfolio that protects loom right into early 2042.
Gregg: We'll continue to vigorously protect and to defense.
Gregg: So <unk> continues to offer a high growth and high value opportunity built on a highly leverages will cost structure, which we believe will deliver significant cash flow and EPS growth over time.
Gregg: We remain both confident and optimistic about <unk> prospects in 2025 and beyond we look forward to sharing commercial and key company progress updates throughout the year.
Gregg: We thank you for joining us and your time today and as always for your support.
Gregg: We'll now open the line for Q&A.
Gregg: Yeah.
Gregg: To ask a question at this time, please press star one on your telephone and wait for your name to be announced.
Gregg: To withdraw your question. Please press star one again.
Francois: Our first question comes from the line of Francois <unk> with Oppenheimer.
Gregg: Alright, thanks for the question so.
Gregg: In terms of the sales reps can you just remind us maybe the evolution.
Gregg: Numbers of sales reps and where youre at now and then any thoughts about DTC or is this just a little different given it's more of a rare disease and then I have a follow up yes.
Gregg: Yes, thanks, Frank in terms of our customer facing roles, including our sales reps, we had about a 15% increase in our in our sales team.
Gregg: That was fully effective as of 125 that number is now at 53, and we've basically doubled the size of our field support team.
Gregg: That is also effective as of one 125% and and that is now up to 28.
Gregg: And then we doubled the size of our nurse support team.
Gregg: That's in a fully operational as of one one as well, which also takes it to right at 28.
Gregg: In terms of your comments about DTC and what I'll, just characterize as patient education through media.
Gregg: We've made us a fairly significant increase in both our channels and our investments beginning here in Q1.
Gregg: And it's important in terms of educating and reaching out and connecting and activating patients where they are and where they seek your information. So we spent a lot of time to understand that.
Gregg: Over the course of the last 18 months and we've increased our investment in that area as well.
Speaker Change: Okay, Great and then on the field support and then the nurses can you just what.
Speaker Change: How different are these two you doubled up on field support can you just help us understand what exactly field supports responsibility is yes, it's really twofold and they are really customer facing roles in terms of the physician audience and they are in their offices and their practices. They work on on on patient pull through from the <unk>.
Speaker Change: <unk> prescription becoming active through the point in time when they are on therapy.
Speaker Change: And our following up with the offices in particular in and around retail times for patients. So think of them as post prescription is written to help process the patient through that through the reimbursement process and then once a patient is on therapy. They have the opportunity to communicate and engage with their office staff around where.
Speaker Change: The patient is on their treatment and in particular in and around the retail.
Speaker Change: Are there upcoming refills are or subsequent dose titration, yes, maybe Frank I'll add to that these are the targeted investments. We described last year fully operational as Greg noted $1 25.
Speaker Change: But these are the types of investments that we see is contributing to the early trends, we're seeing now in 2025 and.
Speaker Change: And as they continue to take hold.
Speaker Change: More effective it should naturally lead to more patients on therapy and higher revenue.
Speaker Change: Is there a part like you talked about a couple of different.
Speaker Change: Forces here between the field force nurse support the DTC effort. The reps is there one of these like which which one is most important to get to the switch patients and increase the number of switch patients or is it just an effort of all of them together.
Speaker Change: Yes, we think its a cumulative effect of of of the full the full approach with all resources given our salesforce really start at the very top of the funnel and then our reimbursement team really pulls them through and then our and our our media strategy is meant to educate and activate patients to go go in.
Speaker Change: To talk to their patients or their physicians about it. So I think they're all important in that regard to not only make sure we're driving the right sort of patients into the top of the funnel, but as they go through the funnel, we're working and doing the things necessary to keep them on therapy and as Tom noted and we've noted in our commentary.
Speaker Change: The early trends in terms of the byproduct of these investments are favorable relative to where we thought we'd be at this stage.
Speaker Change: And that is a very confirming sign that the investments are the right approach and then as these trends become more durable and sustainable, but certainly lead to an uplift in net the most important metric metrics, which is net patients on therapy and revenue potential.
Speaker Change: Great. Thank you very helpful. Thanks, Frank.
Andrew Tsai: Our next question comes from Andrew Tsai with Jefferies.
John: Hey, guys. This is John on for Andrew Thanks for taking the question.
Speaker Change: Any additional color on the Q1 patient trends that you can share and then how should we think about gross to net and inventory for Q1 as it relates to your Q1 sales.
John: You saw sizable drawdown I'm sorry.
Speaker Change: No I understand the question Jon I'll take the first part and then let Tom answer the second.
John: Again, I think what we've seen coming off of the.
Speaker Change: The trends in Q4 and in the second half of last year has been.
Speaker Change: Regardless of the metric you're looking at whether it's the top of the funnel metrics in the form of enrollments or patient starts or even as we think about it as patients go into therapy. All of those trends are favorable for us relative to how we've seen the year start versus internal expectations and the trends we saw through the back half of last year. So all of that we think is both phase.
Speaker Change: Verbal from an underlying demand and growth.
Speaker Change: Potential perspective.
Speaker Change: And as those things progress through patients progress through the funnel. So to speak we would expect to see some of that impact and begin to take effect in Q2, but it is also confirming from our perspective in terms of the strategy and where we're deploying our resources and the focus of the organization, including our breadth of it.
Speaker Change: Our targeting more prescribers to expand our prescriber base, while we continue to work on those who have been.
Speaker Change: Fastest adopters of <unk> as well, so I'll turn it to Tom of it on inventory, yes, certainly so thanks for the question listen I think in terms of gross nets.
Tom: It's always highest in the first quarter.
Tom: That's not unique to avid Dallas Chu for any company operating aerospace, it's primarily impacted by.
Tom: By patient dynamics, if you will.
Primarily in the form of.
Tom: Insurance deductibles resetting and we provide financial assistance to patients to make sure. They continue this therapy on numerous.
Speaker Change: With your question on inventory.
Speaker Change: What we have seen so far in the quarter and keep in mind, we're two thirds the way through the quarter.
Speaker Change: But the quantity of inventory in the channel has remained consistent from where it was at the as we exited 2024.
Speaker Change: Great. Thanks, guys.
Speaker Change: Our next question comes from Amit <unk> with Needham.
Speaker Change: Hi, this is going on for Amit. Thank you for taking my question can.
Speaker Change: Can you remind us of the pushes and pulls in your guidance range. What have you assumed for the low end of the guidance, but do you believe needs to happen for you to get to the high end of the guidance range.
Speaker Change: Could that be upside to the upper end of that change.
How do you see first quarter sales related to fourth quarter.
Speaker Change: Flat or slightly down given the first quarter resets.
Speaker Change: And the last one I'll get an additional two months since the January update what are you in terms of patient mix between switches can you talk debate.
Yes, Thanks Peter.
Speaker Change: On the first question and I would just describe in terms of key drivers.
Speaker Change: The forecast and and mix of patients, they're really interchangeable because the two most important metrics. The most important underlying metric is net patients on therapy and that is a byproduct of more patients at the top of the funnel and keeping patients on therapy. So if we have more demand overall and.
Speaker Change: And if that demand the mix of that demand.
Speaker Change: Skews towards switch patients as an example from where it was trending at the end of Q4. Then then all of that will likely each and our persistency efforts continue to show promise like they have early in this year all of that will lead to upper ends of.
Speaker Change: Upper ends of the guidance range or beyond the upper ends of the guidance range. So ultimately those are the most important metrics in terms of patient starts net patients on therapy, and then and the ability to keep them on therapy.
Speaker Change: In terms of your commentary and then I'll, let Tom maybe comment on that.
Speaker Change: Second question, but your your question on what we've seen in terms of mix of patients early on.
Speaker Change: In the course of this quarter in particular around switched patients our commentary around all patient metrics, including switch patients really holds true for all of that right.
Speaker Change: The favorability we've seen across these trends early in the quarter includes the signs of stabilizing and beginning to reverse what I would just describe it the declining switch patient trend at the end of last year. So again I think we feel really good about the early signals and the progress we're making we expect that to translate.
Speaker Change: <unk> into.
Speaker Change: Packed beginning to be felt from a revenue standpoint in Q2, but it's confirmatory of where we're focused and what we're doing.
Speaker Change: Yes, sorry, maybe just a follow on to the guidance.
Speaker Change: To your question around Q1, with what we're seeing so far and again these are early trends but.
Speaker Change: Positive and inline with our expectations.
Speaker Change: We have a clear line of sight to achieving the guidance that we had articulated at the beginning of January.
Speaker Change: With respect to Q1.
Speaker Change: Just a follow on to my previous comments.
Speaker Change: <unk>.
Speaker Change: Thank you.
Speaker Change: Is that what we're seeing so far in Q1, we're pleased with early developing trends.
Speaker Change: The you have to remember that Q1 is very dynamic.
Speaker Change: In terms of gross nets, it's going to be higher in Q1 than it is in subsequent quarters.
Speaker Change: So we're certainly keeping a close eye on that as with the rest of the quarter.
Speaker Change: Got it thank you.
Speaker Change: Our next question comes from the line of Orin Loopnet with HC Wainwright.
Orin Loopnet: Alright, thanks for taking my questions.
Orin Loopnet: Jazz is obviously switched a lot of their xyrem franchise over to XI a wave.
Orin Loopnet: More recently many of those patients switched a long time ago can you just talk about.
Orin Loopnet: Yeah.
Orin Loopnet: I guess youre messaging and the feedback you get from physicians with regards to switching patients whether they have been on the low sodium that way for a long time versus more recent switchers as it appreciably easier to switch somebody who wasn't switched more recently I guess for obvious reasons.
Orin Loopnet: And then when we just talk about hurdles to switching.
Orin Loopnet: How is your insurance coverage relative to the competitor has that changed appreciably in the new year and.
Orin Loopnet: Maybe can you talk about whether there is a difference between your actual coverage and prestige coverage out there is there any fear real or imagined that switching patients would result in them not being able to smoothly get onto dilate such that they are afraid to switch and risks disruption in their therapy and I have a follow up thanks, yes.
Speaker Change: Kind of working in reverse order from a coverage standpoint, our commercial coverage is greater than 90% now we have covered status and reimbursement access and greater than 90% of all commercial lives we've seen.
Orin Loopnet: That's fairly comparable to our competitor.
Speaker Change: <unk> seen improvements in our Medicare covered this year.
Speaker Change: We do that is fairly comparable to our competitors as well we have very little to no coverage in Medicaid primarily because of the penny pricing that exist in the marketplace today, but over 80% of this market, 82% to 85% of this market is commercial so we believe we're well positioned from a competitive standpoint.
Speaker Change: Like many products early in their launch it as a fairly standard objection you receive around the perception that access may be difficult or you don't have the same coverage.
Speaker Change: And then as an established product, but thats something we continue to sell through and communicate and engage with to change if those perceptions exist that any individual physician physician level by and large when we've seen switch patients get prosecuted we haven't seen a significant hurdle or challenged for the most part in terms of being.
Speaker Change: To effectively.
Speaker Change: Driver switch.
Speaker Change: And deliver switch through the payer or the reimbursement process there will be steps they have to go through to get coverage, but those are pretty well laid out and for the most part those patients will have met all of the step edit criteria that would exist before being able to go onto an ox bait given the parity coverage we have today.
Speaker Change: From that standpoint in terms of the demographic or that the type of patient who has switched or or is switching.
Speaker Change: And where they are in there are and they're kind of treatment journey of being on and off.
Speaker Change: <unk>.
It really I Wouldnt say, there isn't really one.
Speaker Change: Core demographic, whether they've been on an ox debate for a long time or for a shorter period of time, we certainly early in the launch saw patient switching who we would describe is much more dynamic patients who were looking.
Speaker Change: I would say early adopting patients who are looking for the next therapy so to speak.
Speaker Change: Today, as we see switches come in they come in all different forms different demographics different lengths of therapy and different reasons for why they want to consider the switch so for us the key to that is to stay vigilant and and our commercial efforts in our promotional efforts around the.
Speaker Change: The reasons to switch and the opportunities to switch from that standpoint. So that's an important thing that we're focused on this year and how we built the management programs around that.
Speaker Change: And the commercial programs around that to ensure that switches and important messaging for us in particular, not only where we have strong adoption, but the larger part of the market, where we're really focused in expanding our reach and impact.
Speaker Change: I appreciate the question.
Speaker Change: Okay, and just quickly you did mentioned litigation I don't know, if Jared or Andy I'd like to comment more on any of these rfps and even on the call.
Speaker Change: With regards to your expectations on timing of next steps.
Speaker Change: How long do you expect to hear anything back from the appellate Court post oral arguments at the beginning of the month and do you also have any expectations around the royalty determination and the timing of next steps as we can think about sort of how long that process will take to work itself out one way or another.
Tom: Hey aren't as Tom So I'll take the last part of your questions there the hearing.
Speaker Change: Was on February 7th.
Tom: With respect to the IV conjunction.
Speaker Change: When do you expect to.
Speaker Change: We don't have exact timeframe of course, it's up to them to decide when the lithia ruling, but we have an expectation within two to three months following that following that hearing.
Speaker Change: On the on the royalty decision.
Speaker Change: I would just simply describe is pending at this point.
Speaker Change: All parties have.
Speaker Change: Submitted to the judge what he had asked.
Speaker Change: And.
Speaker Change: We're just awaiting a ruling at this point.
Speaker Change: Yeah.
Speaker Change: Okay. Thank you.
Speaker Change: Sure.
Speaker Change: Our next question comes from the line of David <unk> with Piper Sandler.
Speaker Change: Thanks, just got a couple.
Speaker Change: Maybe this is sort of a backward looking question, but do you feel like with the sales organization. Initially after the launch there was just a lot of low hanging fruit.
Speaker Change: In terms of.
Speaker Change: Pent up demand and maybe a more robust switch market.
Speaker Change: You've found that the sales organization is just going to have to work harder to get that incremental patient or at least get.
Speaker Change: More switch patients. So that's number one and then maybe with that in mind can you just talk about how.
Speaker Change: How you feel about the performance of the sales organization, particularly these past couple of months since.
Speaker Change: The guide.
Speaker Change: And then.
Speaker Change: Secondly, I want I wanted to get your thoughts on.
Speaker Change: Just the long term implications of.
Speaker Change: Yes, the erections, which is sort of an elephant in the room here at least long term and how youre thinking about the oxidate market or the direction of the <unk> market in narcolepsy.
Speaker Change: Specifically.
Speaker Change: Do you feel like you'll be in a position to hold on to patients do you expect pressure.
Speaker Change: Where youre going to need to make up for that from from IH adoption, just help us better understand how you're thinking about the business over the long term.
<unk> agonists world. Thank you, yes, thanks, David to your first round of questions around the sales force I'm really proud of the way they have embraced the the expansion of our commercial strategy and the focus of our commercial strategy over the last couple of months the trends have demonstrated that.
Speaker Change: In terms of what we see happening across our primary our primary field based demand based metrics really around what happens at the top of the funnel and at the bottom of the funnel.
Speaker Change: But I believe we've over indexed early in the launch and what we characterize as adopters and we probably had some low hanging fruit, but we've also been quite successful in that audience and now we're expanding our efforts into the broader octavate prescriber base and we're seeing early signs of expanding our reach and impact there as well so I'm proud of our sales force.
Speaker Change: The efforts that they are that they are delivering right now and feel really good about the momentum there.
Speaker Change: They are trading specifically.
Speaker Change: In terms of your question excuse me around Orexin, there's clearly a lot of investor excitement about about the prospects of erections. What we are most interested in is the clinician and prescriber perspective. So it's certainly an exciting new mechanism of action that can a decade.
Speaker Change: These three series fleet conditions with clear benefit on the daytime it's a little less clear what their benefits at night are and whether those are positive or whether in fact, they may lead to some potential concerns.
Speaker Change: But we certainly do believe that there's going to be.
Speaker Change: Our role of the use of <unk> as a 1919 agent that also helps consolidate sleep and produces additional daytime benefits as our data says our goal is to make sure a loom rises that oxidative choice. So we've been investing a lot of time in this and really talking and researching with hundreds of physicians in this regard and our expectation is that there will.
Speaker Change: Continue to beat listening to physicians will be continue to be a roll of box abates.
Speaker Change: And.
Speaker Change: Our goal is to make <unk> that oxidative choice.
Speaker Change: Alright. Thanks.
Marc Goodman: Our next question comes from the line of Marc Goodman with Leerink partners.
Marc Goodman: Hi. This is another one the line from Mark just a couple from us as well.
Speaker Change: I'm curious are there specific geographic regions, where there are lower rates of cardiovascular comorbidities and the narcolepsy population, where your once nightly could be more attractive than the low sodium option and where you could capture.
Speaker Change: I would expect to capture greater market share.
Speaker Change: And then also just.
Speaker Change: Curious if you can share any specific initiatives that you are planning to implement to increase persistency in the UK oxidate patients. Thank you.
Speaker Change: Yes, Thanks, I'll, maybe I'll take the questions in reverse from a persistency standpoint, we have obviously spent a lot of time identifying where these discontinuation risks are and we've introduced very targeted programs.
Speaker Change: To try to intervene and engaged specifically with patients.
Speaker Change: Scriber through data with.
Speaker Change: With the goal of really meeting the patient with the right message at the right time and again early in the quarter, but we've seen positive signs so far those initiatives across our different investments in terms of your question about.
Speaker Change: CV risk.
Speaker Change: Geographically or whatnot, what we can say on that topic as we have now conducted a number of research projects with close integrated health care systems, and CV risk in terms of.
Speaker Change: Patients with narcolepsy people with narcolepsy doesn't show up in the top 20 Comorbidities.
Speaker Change: And relative to the <unk>.
Speaker Change: Trolled cohort of the standard patient population. We know there is a percentage of patients overall that we've got physicians talk about to us in that 10% to 15% range, who may have some sodium sensitivity or other matters, but I can't tell you that there is a geographic area around that we haven't seen a geographic.
Speaker Change: Disposition, one way or the other from that perspective, what we know is that once nightly dosing is viewed as a highly important attribute for people who suffer from chronic sleep disorder.
Speaker Change: And over the last 18 months, we have.
Speaker Change: Patient starts three to one to the next nearest competitor. So we're pleased with the early trends we've seen in 2025 and continue to.
Speaker Change: And to continue to build on that momentum, yes, maybe I'll, just add persistency listen support across all patient segments.
Speaker Change: As we continue our initiatives. We believe we are working on the right things doing the right things and as we continue to.
Speaker Change: To drive those.
Speaker Change: <unk> just against one of those metrics and naturally leads to an improvement in revenue throughout the year.
Speaker Change: Thanks.
Speaker Change: Our next question comes from Miriam, Doug EDI with lifestyle capital.
Speaker Change: Yeah.
Speaker Change: Thank you.
Speaker Change: Good question.
Speaker Change: As you're targeting the broader prescriber base many are writing for oxy.
Speaker Change: How are you thinking about converting physicians to regulators.
Speaker Change: Do you have any specific feedback from that articulate.
Speaker Change: The one off it's hybrid.
Speaker Change: Yes from a market expansion perspective, Miriam it's another really Great example of what <unk> is bringing to the <unk> category in totality, we've seen well over 200 physicians, who had never written oxalate before now prescribed <unk> and many of them have written for more than one from.
Speaker Change: Some have written quite a few so from that perspective, it really is.
Speaker Change: It's organic in terms of what's happening because these physicians are kind of signing up by enrolling in a rems program, which gives us a trigger that they want to use loom rise.
Speaker Change: What we've done in terms of our sales force expansion is to try to identify physicians, who look a lot like those physicians and expand our reach into a new audience to try to if you will generate even more new Oxford <unk> prescribers, but we're pleased with what we've seen so far and it's a great signal in terms of the ability to grow the market.
Speaker Change: Okay. Okay.
Speaker Change: Question and James.
Speaker Change: For 2020.
Speaker Change: You have an ideal ratio and mindful switch.
Speaker Change: Thank you.
Two oxidate population look.
Speaker Change: They are critical in terms of Barclays.
Jason: Thanks, Jason.
Jason: Various Tom so listen we have certainly set our internal goals.
Jason: How we're tracking so far is clearly in line with our internal expectations two months into the year.
Jason: Our goal is not just to improve patient mix. It's also to drive overall demand as we referred to the top of the funnel.
Jason: All of these initiatives.
Jason: Whether it be top of the funnel patient mix persistency all are designed to continue to improve revenue throughout the year.
Speaker Change: Got it thank you.
Question.
David Wong: Our next question comes from the line of David Wong with Deutsche Bank.
David Wong: Hi, Thanks for taking the question.
David Wong: Just wanted to ask a little bit about your efforts to.
Speaker Change: Persistency in the naive or new to brand patients. So what specifically can you do there and what would you expect the long term.
Speaker Change: And see a discontinuation rates will look like for those patients do you think it would be in line or better than twice nightly oxalates.
David Wong: Yes, David we covered that.
David Wong: On a number of questions, but let me just give you a little bit more perspective.
David Wong: In terms of our efforts from a persistency standpoint, we're really focused in three different areas. One is our direct engagement with patients through our nurses to our direct engagement with office staff around patients on therapy, and three supporting persistency throughout with our pharmacy partners. So whether you are new to <unk> switch patient or another one.
David Wong: We're trying to we're intervening with all those patients and again, even through this part of the launch.
David Wong: We our persistency rates certainly better than the legacy twice nightly first generation products, but from our viewpoint, that's not good enough and we're continuing to make strides to improve it.
And in early so far this year, we're seeing some positive signs of those interventions.
David Wong: If those and as those those trends continue on and became sustainable and durable we would expect to see that result in more net patients on therapy, which resulted in an uplift in revenue.
David Wong: Yes.
Speaker Change: Our next question comes from the line of Brandon Folkes with Rodman <unk> Renshaw.
Speaker Change: Alright, thanks for taking.
Speaker Change: All my questions and I appreciate all the color.
Speaker Change: I wanted to follow up on a question.
Speaker Change: I think twice already but you mentioned, you're seeing very good trends in <unk> and you expect this to translate into revenue growth in the second quarter.
Speaker Change: I appreciate the industry headwinds that we will see and we can keep it.
Speaker Change: I wanted to be careful I'm wondering are you implying that we should consider the potential of a sequentially down.
Speaker Change: Quarter on quarter revenue.
Speaker Change: Quarter, and <unk> have a full queue or can you rule. This out at this stage given sort of the early indicators that youre seeing from what you put in.
Tom: So hey, Brian It's Tom Let me, let me start on that so this is the first time since <unk> launched we provided revenue guidance and granted it was for the full year.
Speaker Change: And in the range of $240 million to $260 million. We're we're we haven't provided quarterly guidance.
Tom: Don't.
Tom: Don't intend to at this point.
Tom: Stay tuned for future quarters, as we evaluate the ongoing market dynamics.
Speaker Change: Nate you recognizing the Q1 dynamics occur for any company in our stage, particularly around gross to nets, it's a very high quarter in terms of gross nets.
Speaker Change: Obviously, we're monitoring it and keeping a close eye on it.
Speaker Change: But that's where we stand at the moment, but again I think what's important for us as the initiatives, we laid out what we're working on which should lead to continued improvement throughout the year and for US at this point at a high level of confidence and a clear line of sight to achieving the guidance we provided.
Speaker Change: Thanks, and I do appreciate all the color maybe just wanted to follow up any color on the pediatric indication just sort of how that launch is going today and how youre thinking about its contribution in 'twenty five and then that's it from me. Thank you.
Speaker Change: Yes, it's clearly a focus we've added some more physicians who are exclusively pediatric prescribers are pre pediatric treaters and we've got really great stories.
Speaker Change: Parents and families benefiting from the introduction of Bloom rise with a formal approval and being able to get clear coverage from that standpoint, it's a relatively small percentage of patients overall and and.
Speaker Change: In terms of the total market given just how the diagnosis of patients occur. It can take upwards of 8% to 15 years from onset of symptoms to a formal diagnosis diagnosis, which most patients are in their twenty's or <unk> when that occur. So, but we are focused on it we've got very specific segmentation within each of our respective geographies.
Speaker Change: And pursuing it accordingly.
Speaker Change: We're proud to be able to offer.
Speaker Change: This patient population as well.
Speaker Change: Okay.
Speaker Change: Great. Thank you very much thank you.
Speaker Change: That concludes today's question and answer session I would like to turn the call back to Greg Davis for closing remarks.
Speaker Change: Thank you and thank you everyone for joining us and really appreciate your time. This morning look forward to our follow ups through the course of today in this week.
Speaker Change: And have a great day. Thank you.
Speaker Change: This concludes today's conference call. Thank you for participating you may now disconnect.
Speaker Change: Okay.
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Speaker Change: Okay.
Speaker Change: Yes.
Speaker Change: [music].