Harmony Biosciences Holdings Inc (HRMY) 2022 Q1 法說會逐字稿

Good morning. My name is Ashley, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences First Quarter 2022 Financial Update Conference Call. (Operator Instructions) Please be advised that today's conference may be recorded. (Operator Instructions)

I will now turn the call over to Luis Sanay, Head of Investor Relations. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences first quarter 2022 financial performance and provide a business update. Before we start, I encourage everyone to go to the Investors section of our website to find the press release and slides that accompany our discussion today, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our lifecycle, we believe non-GAAP financial results better represent the underlying business performance.

Our presenters on today's call are John Jacobs, President and CEO; Dr. Jeffrey Dayno, Chief Medical Officer; Jeffrey Dierks, Chief Commercial Officer; and Sandip Kapadia, Chief Financial Officer.

Moving on to Slide 2. As a reminder, we will be making forward-looking statements today which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties, and our actual results may differ materially. I encourage you to consult the risk factors referenced in our SEC filings for additional details.

I would now like to turn the call over to our CEO, John Jacobs. John?

Thank you, Luis, and thank you, everyone, for joining our conference call today. During the first quarter, we continued to execute on our 3-pillar growth strategy, with progress across all 3 pillars and achieving 2 key milestones. We're excited about the momentum we see in the business, and as you've heard me say previously, we're looking forward to making 2022 our best year yet.

Now I'd like to take a few minutes to highlight our progress on each of the 3 pillars of our growth strategy in the context of quarter 1 2022 performance. Starting with Pillar 1, which is to optimize the commercial performance of WAKIX. In Q1 '22, we delivered a strong quarter for WAKIX with revenues of $85.3 million, a 43% year-over-year increase on the quarter. We also reached an important milestone surpassing $500 million in cumulative net revenue for WAKIX since our launch in November of 2019.

The first quarter performance reflects the anticipated seasonal payer dynamics, which our Chief Commercial Officer, Jeff Dierks, will discuss in further detail later in the call. WAKIX underlying business fundamentals remained strong during the quarter, with March representing our strongest month of performance in top line prescription demand and new patient starts in over a year. For the remainder of the year, we expect quarter-on-quarter growth for WAKIX due to strong underlying demand, and the large and growing opportunity in narcolepsy.

Let's move on to Pillar 2, which is to expand the clinical utility of WAKIX beyond narcolepsy. This quarter we reached yet another milestone towards delivering innovative therapies that improve the health of people living with rare neurological diseases. Last week, we were pleased to announce the initiation of our Phase III registrational trial for pitolisant in idiopathic hypersomnia, or IH. We're excited to advance this program, and we are hopeful these efforts, if successful, will lead to the next indication for WAKIX. With the IH program now in the clinic, we have 3 clinical programs underway for pitolisant, including Prader-Willi syndrome, myotonic dystrophy and idiopathic hypersomnia.

Furthermore, we're advancing our second asset, HBS-102 into the preclinical proof-of-concept stage to explore its effect in Prader-Willi syndrome on the symptoms of hyperphagia, weight gain and other metabolic parameters. Dr. Jeffrey Dayno will share more on HBS-102 later in this call.

And finally, Pillar 3, acquiring new assets through business development to expand our portfolio beyond WAKIX. Over time, our intention is to develop a broad portfolio of rare orphan neurology assets and/or assets and other neurological conditions where we can leverage our existing expertise and infrastructure. To achieve this, we are seeking assets across a range of development stages, including both early and later stage, with the potential to launch both during and after the WAKIX lifecycle.

Now it's important that we're beginning this journey early in our company history, so we can take the time to be thoughtful and prudent in what we acquire and flexible in the types of deals we are able to consider, and Harmony is in a good position to execute on this strategy. We are intently focused on doing this and are optimistic regarding our potential to make progress here, based on our strong financial position and current market conditions.

Overall, I'm extremely pleased with the continued execution on our 3-pillar growth strategy, which puts us in a very strong position to build for the future. We remain confident in WAKIX being a potential $1 billion-plus franchise in the coming years via narcolepsy and additional indications. And with that as a foundation, I am truly excited about what we can achieve next at Harmony. Our vision is to evolve into a leading neurology company with a broad portfolio of innovative assets that have the potential to improve the health of people living with rare and other neurological diseases.

I would now like to turn the call over to Jeff Dierks, Harmony's Chief Commercial Officer. Jeff?

Thanks, John. We made significant strides in advancing our narcolepsy business in the first quarter, both in net revenue and underlying business fundamentals. Net revenue for the first quarter was $85.3 million, representing approximately 43% increase from Q1 2021. In the first quarter of 2022, we surpassed $500 million in cumulative net revenue, a milestone that was achieved in less than 2.5 years since our launch. Our strong performance since launch continues to reflect not only the resilience and commitment of our team, but also speaks to how the overall benefit risk profile of WAKIX aligns with the significant unmet medical need in the narcolepsy market.

Now moving on to Slide 5. I'd like to highlight a few of our underlying business fundamentals that drove our continued growth in the first quarter of 2022. The average number of patients on WAKIX increased to approximately 3,900 in the first quarter, which is reflective of the anticipated once-yearly seasonal dynamics of managed care reauthorization and patient assistance program reverification, typical for branded specialty products in the first quarter each year.

We experienced these same seasonal payer dynamics the previous 2 years of our launch in the first quarter. As we are now in our third year of commercialization and the majority of our patients are continuing patients versus new patient starts, a larger percentage of our patients are subject to payer reauthorizations and reverification than in previous years. Due to our strong market access coverage, the vast majority of patients saw immediate approvals, although some patients experienced delays in their prescription approvals.

A smaller group of patients, mostly government-insured patients, did not continue on treatment due to not meeting financial need criteria through third-party support. Additionally, some patient assistance program patients did not meet program eligibility requirements and no longer continued on free goods. Absent these onetime events, the government pay and free good patients, we would have experienced similar average patient growth as prior quarters.

Moving forward, we are confident in continued growth of WAKIX. March represented our strongest month of performance in top line prescription demand and new patient starts in over a year, and provides strong momentum in our business as we head into Q2.

Turning to our prescriber base. We observed a further broadening and meaningful clinical adoption of WAKIX. We saw further growth in new prescribers for WAKIX in the first quarter of 2022, both in writer of traditional narcolepsy treatment as well as health care professionals who have been reluctant to prescribe other available scheduled narcolepsy treatment. The majority of these prescribers have become repeat writers, meaning they have written a prescription for WAKIX for 2 or more of their narcolepsy patients since launch. We are pleased with the continued growth in both the depth and breadth of our prescriber base, demonstrating the growing opportunity for WAKIX in adult narcolepsy. We continue to see broad utilization of WAKIX for both type 1 and type 2 narcolepsy patients, and WAKIX being prescribed as monotherapy as well as concomitantly with all other narcolepsy treatments.

We saw an increase in in-person field sales engagement with health care professionals in their office staff, in the first quarter of '22 from the fourth quarter of 2021. More than 70% of all field sales engagements were in-person by the end of the first quarter. The increase in access towards the end of the first quarter speaks to an opportunity for further education and engagement in the second quarter, and provides an opportunity for our expanded field sales team to drive WAKIX growth in both new and existing prescribers.

We completed the expansion of our field sales team with all positions hired, trained and in their territories by April 1, in line with what we communicated in our last earnings call. We expect to see the benefit of this expansion in the second half of 2022 at the earliest. The expansion of our field sales team gives us added confidence in our ability to continue to grow WAKIX.

In summary, the continued strong performance in underlying business fundamentals of WAKIX and the narcolepsy market affirm, our confidence in WAKIX as being a potential $1 billion-plus franchise opportunity. I'm excited as we head into the second quarter, with momentum in all the following areas: strong top line prescription demand and continued growth in the average number of patients on WAKIX; the broadening of the depth and breadth of our prescriber base; strong market access for WAKIX; and continual improvement in access for type 1 patients; increased access to health care professional offices for in-person education by our field sales team; and our expanded field sales team in place to extend our reach to the broad narcolepsy treating health care professional universe. But most importantly, I'm excited about the difference WAKIX is making in the lives of people living with narcolepsy.

I'll now turn the presentation over to Dr. Jeff Dayno for an update on our clinical development program. Jeff?

Thanks, Jeff, and good morning, everyone. I am pleased to provide an update on our clinical development programs and Pillar 2 of our 3-pillar growth strategy, to expand the clinical utility of pitolisant.

First off, as we announced last week, we are excited about the initiation of our Phase 3 registrational trial in adult patients with idiopathic hypersomnia, or IH, also known as the INTUNE study. Highlights of this trial can be found on Slide 6. The primary objective of this trial is to assess the efficacy and safety of pitolisant compared with placebo, in treating Excessive Daytime Sleepiness, or EDS, in adult patients with IH, as measured by the Epworth Sleepiness Scale, or ESS.

Key secondary endpoints include assessment of the symptom complex of IH utilizing the idiopathic hypersomnia severity scale and patient global impression of change. The trial will also assess the impact of pitolisant on what is commonly referred to as brain fog, by measuring cognitive function at baseline and after treatment with pitolisant in patients with IH.

The trial design is a double-blind, placebo-controlled, randomized withdrawal study with a target enrollment of about 200 patients. Approximately 60 to 80 sites in the U.S. will be participating, and over 100 clinical trial sites have been evaluated for this trial. There has been much interest from both the patient and sleep medicine communities in investigating pitolisant in patients with IH, and we are pleased with the pace of study start-up activities. We appreciate the efforts of our clinical investigators and the participation from the patients and families in the IH community that we are actively working with. We are excited about the INTUNE study, and if positive, could lead to the next new potential indication for WAKIX, for another rare neurological disease patient population with significant unmet medical need. We look forward to providing updates on the INTUNE study on future calls.

Turning to our other life cycle management programs for pitolisant, which are shown on our pipeline slide or Slide 7. We have made good progress on our Phase 2 proof-of-concept trial in patients with Prader-Willi syndrome, or PWS, and are on track for top line data in the second half of this year. For our Phase 2 trial in patients with type 1 myotonic dystrophy, or DM1, we continue to activate new sites and enroll patients with top line data anticipated in 2023.

Lastly, a few words on HBS-102, our early-stage asset which is a Melanin Concentrating Hormone receptor 1 antagonist as shown on Slide 8. We are working with one of the top labs in the country in MCH biology, and are on track to initiate a preclinical proof-of-concept study later this year. The objective of this proof-of-concept study will be to assess the potential utility of HBS-102 for the symptom of hyperphagia as well as its impact on weight gain and other metabolic parameters, utilizing an established mouse model of Prader-Willi syndrome.

MCH neurons are located in the hypothalamus and function as a key control center of feeding behavior, as well as hormonal and autonomic control of energy metabolism. We will provide an update on the time line for data readout of this preclinical proof-of-concept study later this year.

In closing, we are excited about the initiation of our INTUNE study in adult patients with idiopathic hypersomnia, which accelerates our clinical development program to a Phase 3 registrational trial. If positive, this would move us closer to a potential new indication for WAKIX in another rare neurological disease with unmet medical need.

Thank you, and I'll now turn the call over to our CFO, Sandip Kapadia, for an update on our financial performance. Sandip?

Thank you, Jeff, and good morning, everyone. This morning, we issued our first quarter 2022 press release and filed our 10-Q, where you'll find the details of our financial and operating results. Our first quarter performance is also shown on Slides 9, 10 and 11. We continue to show strong year-over-year revenue growth and operating income while continuing to generate cash flow from operations. I'm pleased with how we started 2022 and the momentum we're seeing, and the outlook for the balance of the year.

For the first quarter of 2022, we reported $85.3 million in net revenues for WAKIX compared to $59.7 million in the prior year quarter. This represents a growth of 43% and reflects the continued growing demand for WAKIX. As expected, we did see the impact of seasonal payer dynamics in the early part of the first quarter, resulting in higher gross to net deductions, as well as a typical reduction in trade inventories during the quarter. We expect these dynamics to normalize throughout the balance of the year.

During the first quarter of 2022, operating expenses were $43 million compared to $34.7 million in the prior year quarter. The growth in operating expenses continues to be driven by our commercialization of WAKIX and the advancement of our pipeline programs. As a result, we had operating profitability improvement as we reported first quarter 2022 operating income of $27.6 million compared to $14.5 million in the prior year quarter.

Non-GAAP adjusted net income for the first quarter was $31.1 million or $0.51 per diluted share compared to $16 million or $0.27 per diluted share in the prior year quarter. Starting in 2022, we have updated our GAAP to non-GAAP reconciliation to better align with other commercial stage biotech companies. We believe the updated measure better reflects the underlying business performance when non-cash, non-recurring onetime items are excluded. Thus, non-GAAP adjusted net income excludes non-cash interest expense, depreciation, amortization, stock-based compensation and other non-operating items, along with the tax effect of these items. Please see our press release for a reconciliation of this measure.

During the first quarter of 2022, we generated approximately $29 million of cash from operations and ended the quarter with $224.5 million in cash and cash equivalents as of March 31. During the quarter, we also surpassed $500 million of cumulative WAKIX net revenue since launch, which triggered a final $40 million milestone payment to our partner, Bioprojet.

Looking ahead, we have strong business momentum and have navigated the earlier payer dynamics, and we expect quarter-over-quarter net revenue growth for the balance of 2022. We also expect to increase in investment in R&D and SG&A, as we continue to successfully execute on our 3-pillar growth strategy.

So, in conclusion, we continue to operate from a position of strength with growing revenues, prudent expense controls, a solid balance sheet and access to additional capital. We believe that WAKIX has the potential to be a $1 billion-plus franchise based on narcolepsy and other indications in the coming years. We look forward to reinvesting our capital to fund our ongoing development programs and acquire additional assets.

And with that, I'd like to turn the call back to John for his closing remarks. John?

Thank you, Sandip. In summary, our business fundamentals continue to be strong, putting us in a good position to execute our 3-pillar growth strategy and make 2022 our best year yet in company history. Our intent is to continue growing WAKIX sales in narcolepsy via good commercial execution and strong organic demand for this unique and meaningfully differentiated product, to continue to advance our clinical programs with the goal of expanding the utility of WAKIX beyond narcolepsy, to help bring this innovative therapy to new patient populations and to acquire new assets beyond WAKIX to expand our portfolio, with the vision of evolving Harmony into a leading rare neurology company with sustainable long-term growth potential. We look forward to updating you on our progress throughout the year.

This concludes our planned remarks today. Thank you for joining our call, and I will now turn things back over to the operator to facilitate the Q&A session.

Operator, can we please open the call to questions?

(Operator Instructions) And we'll take our first question from Danielle Brill with Raymond James.

I just have a couple of clarifying questions on the outlook for WAKIX and what you said on March being so strong. Was this driven by patients with reauthorization delays coming back online? Or was this an increase in new prescriptions? And then should we be anticipating that patient adds increasing back to the historical 300 to 400 range moving forward?

Q1, organic demand for our product was actually very strong and stronger than what we experienced in Q4, actually. But as we predicted, we have seasonal dynamics in Q1. So why don't I hand your question over to Jeff Dierks for -- to add a little bit more color to that. Jeff?

So with respect to March, March represented the strongest month in terms of top line prescription demand and new patient starts. So this is new organic demand versus the reauthorization. And when you -- your second question about net patient adds moving forward, although we're not providing forward-looking guidance, we do anticipate returning to the prior quarterly growth in average patients moving forward in '22. So I hope that answers your question.

And we'll take our next question from Chris Howerton with Jefferies.

I guess, a similar vein of questioning for me. I'd be curious to know if you could provide some information of durability of patients on WAKIX, maybe average time on drug or maybe something around the refill rate would be useful. And then in terms of kind of the dynamics moving forward, I just -- I guess, a clarification from me. Jeff, you said that the headwinds were from government payers and patients not meeting assistance for payment. I guess I was wondering if you could have a little more clarification on that in terms of the relative demand that you guys just articulated.

Go ahead, Jeff, you want to take that question from Chris?

Yes. Sure. Thanks for the question, Chris. So with respect to durability in terms of the average time on drug, what we're seeing -- and we've communicated publicly that the average discontinuation rate for products in this category at 12 months range is between 30% and 50%. And what we're seeing, although it's still very early in rolling in our third year of commercialization, WAKIX is falling right in the middle of that range, and it's consistent with what the expectations are from patients, from health care professionals. So we're very pleased with how well the product is being received by the narcolepsy community.

With respect to your second question on the dynamics with respect to the government pay patient, right, so, one context is, government pay is about 15% of the overall payer mix, so just to help kind of characterize the size of that opportunity. But I'm sure as you're aware, some government-insured Medicare patients seek third-party assistance programs to provide financial assistance with insurance premiums with their co-payer, co-insurance diagnostic test assistance, and through independent data on the annual reauthorization process, because this is an annual reauthorization process.

Some of the patients didn't meet those independent financial need criteria or didn't receive enough eligible funding to continue on treatment, which ultimately resulted in fewer patients on drug. And this is anticipated every year. Obviously, it's reflected in our average number of patients on WAKIX for the first quarter. But absent that and the patient assistance reauthorization, we're very confident we would experience similar patient growth in terms of average number of patients from prior quarters. And as I kind of shared in my response to Danielle, we're extremely pleased and excited about the performance that we've seen. March was the strongest month we've had in over a year in terms of new patient starts and top line demand. And we are really optimistic about looking to return to prior quarterly growth. And we remain confident that WAKIX is that potential $1 billion-plus franchise.

And one thing, Chris, I also wanted to add into, we talk about average number of patients, and they were about 3,900, but we exited the first quarter with approximately 4,100 active patients on WAKIX. And I think exiting patients is likely a better metric for the true demand for -- in Q1, given the anticipated seasonal payer dynamics that we experienced, right. We have a stronger base of continuing patients. And so, some of those reauthorizations on refills and new patient starts get pushed into February and March. So the rate of average patient growth in the first quarter is slightly less due to the anticipated Q1 dynamics. So just to kind of give you a sense that we're really very, very pleased with our performance. We've got great momentum heading into Q2. These onetime events are behind us, and we've got a great outlook for the rest of...

Right, Jeff. And one of the best lead indicators is, the organic demand for our drug was higher in Q1 than it was in Q4. So these are anticipated seasonal dynamics, and the strength of our business is really robust as we move forward into 2022.

That's really helpful. And I don't know if you're able to tell us, Jeff, but what was the exit number at the end of 4Q in terms of patients -- active patients?

Yes. Chris, we haven't disclosed that information. And honestly, we haven't even looked at that data, but we can circle back with you and Brian in a follow-up call.

And we'll take our next question from Charles Duncan with Cantor Fitzgerald.

Congrats on the commercial and development progress in the quarter. And let's see, a quick question regarding -- yes, we talked a little bit about the first quarter. I guess I'm wondering if you can provide guideposts for the full year '22, given the learnings from the first quarter? And then secondarily, maybe for Jeff, you mentioned second half of the year impacted the earliest. I guess, I'm kind of wondering why you say at earliest and how would you best measure?

Okay, Charles was asking about full year guidepost. Did you want to answer that question first?

Yes, sure. I mean, as you know, we're not providing more forward-looking guidance. But what I can say about the business is, we've got good strong fundamentals, Jeff, to get through some of the details. We would expect quarter-over-quarter growth for the balance of the year both in terms of patients and net sales growth. So we expect continued momentum that we're seeing certainly coming out of March and going forward. So hopefully, that gives you a little bit of context in terms of our expectations for the year.

And I think, Charles, your second question was about salesforce impact of our expansion. Jeff Dierks, did you want to handle that?

Yes, absolutely. As we've shared, we've expanded our sales team by about 10%, and obviously, we completed the expansion with all the positions hired, trained and in their territories by April 1. We're expecting to see the benefit of this expansion in the second half of the year, simply because we know it takes time to build relationships. And obviously, in sort of a COVID-depressed environment, it's difficult for us to be able to reach all of our targets. So what we've shared is, about 70% of our interactions are in-person. So you would anticipate it likely may take 6, 7, 8 calls for an individual to change the behavior from a prescriber through education. So we're simply just allowing that opportunity, and we're expecting the second quarter to build those relationships, learn their geographies, really start to get out and educate those health care professionals, with the impact of likely new prescription uptake and new patient starts in the second half of the year at the earliest, if that helps.

One quick commercial follow-up, and that is regarding market dynamics, given the change with regard to competitive landscape on Sunosi company. I cover it has acquired that product, and they don't currently have commercial effort. But do you see anything changing with regard to narcolepsy market dynamics, given Sunosi marketing, and then the positioning of WAKIX versus Sunosi?

Yes. In my perspective, I don't see any changes in the narcolepsy markets. Sunosi has been around since July of '19. It's an active treatment option. We believe WAKIX is growing the branded segment of the market by offering a meaningfully differentiated product profile, the only non-scheduled treatment option available, a novel mechanism working for histamine. And so, given a large undiagnosed patient population, the significant unmet need and really differentiated product profile for WAKIX, we believe there's plenty of room for multiple branded products. We're really excited about the strong demand that we're seeing with WAKIX in Q1, and really supports our belief in the long-term opportunity for the brand.

Thanks, Charles. Just wanted to welcome you aboard as a covering analyst, and thank you for joining us. It's great to have you here today.

Yes. Thanks. Excited to be here.

And we'll take our next question from David Amsellem with Piper Sandler.

Just a couple. First, I apologize if I missed this, but can you talk about, generally speaking, the time it takes to get a script filled? What did that look like in the first quarter? And what does that typically look like if you take away the seasonal dynamics? And I guess where I'm getting at here is that, are you getting any sort of dynamics where you've got patients that are just walking away from a prescription because of the payer hurdles, whether they're seasonal or just more ongoing? So that's the first question.

And then secondly, can you just give us a refresher on the mix between type 1 and type 2 narcolepsy? And actually, with idiopathic hypersomnia in mind, are you even seeing any evidence of a little bit of off-label use in IH?

David, when it comes the time to fill, I mean, obviously, since launch in 2019, we've seen significant improvement in the efficiency of being able to convert the prescription request into an actual patient on product, and that's to be anticipated in a rare orphan launch. And I think Jeff Dierks, you may want to add some additional color to that, but we've seen since launch in '19, a remarkable improvement in that efficiency over time.

Yes. John, thanks. And David, to your point, the time to getting a prescription fill -- to your point, we have seen some efficiencies in there. And the rates that we're seeing are relatively better than other industry benchmarks when you look at other rare orphans, specialty pharmacy products and the time to fill. So we don't believe that the time to fill has any impact on abandonment. There is some level of abandonment with every single prescription, whether it's an oral oncology product or a chronic disease, and what we're seeing in our abandonment rates is consistent with that for industry standards.

Second question on mix for type 1 and type 2. So we're seeing about 50% of our new prescriptions coming in for type 1 narcolepsy, about 50% for type 2, which mirrors what we're seeing in sort of clinical presentation in the physician's office. They're telling us about half of their patients are presenting with type 1 and type 2. So, WAKIX really is eligible and able to be tapping in to that broad narcolepsy opportunity. We continue to hear that from health care professionals that WAKIX is an appropriate treatment option for all adult patients living with narcolepsy. And so, the data is setting in there. And maybe I can ask Dr. Dayno to kind of assist in terms of interest in IH, and maybe what we're seeing from the KOL community.

Yes, sure. In terms of -- we know that in terms of idiopathic hypersomnia and WAKIX or pitolisant, there's been a lot of interest from the patient community and the sleep medicine community. We do see prescription requests in terms of IH coming into the hub. But obviously, our focus now is on the Phase 3 registrational trial and doing a doing that study in working towards a potential new indication for IH. So, we've been aware of the growing interest in pitolisant for IH and we are focused on the INTUNE study and doing that registrational trial.

And we'll take our next question from Corinne Jenkins with Goldman Sachs.

I was just hoping that you could expand a bit on the drivers that you saw for new patient growth, and March as you spoke about is the strong organic growth. If you have any visibility on what are some of the dynamics that are driving that?

Jeff, any commentary on there, because we saw really strong organic demand for the product in Q1, and you mentioned March. So we have a question about some of the drivers, a little more color and context on that, if you can.

Sure. I mean, what we saw is, the increase in the number of in-person engagements with our field sales team increased to more than 70% in March. So, it was greater in March than it was in February and January. And we know we're still kind of early in our launch per se in terms of the education, given that we've been dealing with sort of this COVID headwind and our ability to access health care professionals. So I think that in-person engagement, educating the health care professional and their staff, was likely a driver. We started to see some increases in patient foot traffic in March following lower foot traffic that we saw in January and February. So those are really the drivers.

I think this is very much an educational opportunity for us, and we continue to see growth in new prescribers as well as increasing the depth of our prescriber base, meaning patients starting a second or a third patient on WAKIX with a prescription. But I think the engagement process with our representatives, getting able to be back in the offices and educating the entire staff -- obviously, as a specialty pharmacy product, there's a health care professional decision. There's the nurse counseling portion of it. There's the billing coordinator and the reimbursement specialists in the office that all need to be educated on and make sure they have that optimal experience. So we're really pleased with the momentum that we saw, Corinne, in March, and I think we're very optimistic in terms of looking forward for the remainder of the year and continuing to make a difference in the narcolepsy community.

Jeff, we're very strongly and consistently adding additional prescribers as well, new prescribers to the drug each month and each quarter on top of the base, who can continue to prescribing many other vast majority and become repeat prescribers for it.

Correct.

And then, to that last point around kind of the whole office engagement you need in order to have a smooth process for prescriptions. Is there anything you expect to change with respect to the number of visits or the amount of handholding you need to do as you expand your sales force to target, maybe primary care in psychiatrists who aren't writing as much narcolepsy prescriptions or may not have the same experience with the specialty pharma.

Yes. Corinne, I think with the new product, obviously, it's a novel mechanism. There's education within every office. And you're right. If you've got someone that's familiar with a specialty pharmacy distribution model, there's likely less education necessary for that and more education on the product. But we have a great educated field sales team that's been expanded. We have a field reimbursement manager team that is out there and able to help support offices going through the reimbursement.

We have a fully staffed and dedicated patient hub. So we really have a very sophisticated white glove service that can really sort of surround that office and make sure that we have all the appropriate touch points. We know that likely there may be some additional investment in time in some of these offices, but we have the right resources to be able to do it. We've seen great success in educating existing psychiatrists and primary care doctors, and we're anticipating a very similar journey with some of these new writers that we continue to bring on board in future quarters.

(Operator Instructions) And we'll take our next question from Francois Brisebois with Oppenheimer.

So I was just wondering, just trying to get a better feel for the prevalence of IH. It seems like the true IH patients, the 18 to 20 hours of sleep are although more rare, but there seems to be comingling of indication. So it seems hard to -- there's just a lot of patients with IH, without the long sleep time, and then there's the narcolepsy type 2 patients that seem hard to distinguish. So I'm just trying to get a feel for how you segment these 30,000 to 40,000 diagnosed patients in IH that you discussed?

Jeff Dayno, why don't you take that question from Frank?

Yes. So in terms of IH -- I think in terms of epidemiology, now it starts with, so the claims data and the number of diagnosed patients based on ICSD criteria in the range of 30,000 to 40,000 patients. I'm going to the literature in terms of the broader epidemiology. It's potentially up to 70,000 to 80,000 patients in the U.S. And you raised a good point. Obviously -- and in the sleep medicine community it's an active discussion, idiopathic hypersomnia exists along a continuum or a spectrum in terms of patients with type 1 narcolepsy, type 2 and then IH.

And I think IH is another central disorder of hypersomnia. There is some of that overlap you're alluding to, especially with NT2. However, you lean on the clinical diagnosis and the clinicians making the diagnosis supported by the sleep studies, and their -- ICSD 2 differentiated between IH patients with long sleep time and those without. Actually, the ICSD 3 criteria sort of took that away. So there is some of that difference in terms of the clinical phenotype. But ultimately, it's how the clinicians make the diagnosis. Obviously, in our clinical trials, we lean on the formal diagnosis of IH patients to be eligible. And then they're managed in terms of -- by the sleep medicine community.

What's also interesting is, when speaking to the KOLs, they say that a lot of them have as many patients with IH per ICSD criteria in their clinics as they do with narcolepsy. So we think it is obviously a significant opportunity for pitolisant going forward, and as I mentioned before, we are focused on the execution of the INTUNE trial in pursuit of the indication.

And then, maybe lastly, in terms of the time for the script to be in the patient's hand, has Harmony ever thought or has ever given out free samples for maybe the first 30 days or first 60 days of use? Or is that not something that's necessary based on it not seeming to really be a problem at this point?

Go ahead, Jeff.

So most of our orphan products do not sample the product. And again, we haven't seen any challenges with abandonment or patients that are walking away for not having a sample. I mean this is obviously a chronic lifelong neurologic disorder where there is no cure. Patients have been waiting for it over a decade, for WAKIX, and so, the time that they are waiting for their prescription is well within industry norms. And as I was saying earlier to another question that I believe David asked, versus benchmarks. We are actually more expeditious in getting patients on product than a lot of other companies. So we're really pleased about the results and the enhancements that we're making within our patient hub and our SP network. And we're really excited about our ability to continue to help patients get on WAKIX.

All right. Thank you. And I'm showing there are no further questions. This does conclude today's Harmony Bioscience First Quarter 2022 Financial Update Conference Call. You may now disconnect your lines and have a wonderful day.

Thank you, everyone.