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Harmony Biosciences Holdings, Inc. (HRMY -2.34%)
Q1 2022 Earnings Call
May 03, 2022, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

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. All participant lines have been placed on mute to prevent any background noise.

After the speakers remarks, there will be a question and answer session. [Operator instructions] Please be advised that today's conference may be recorded. [Operator instruction] I will now turn the call over to Luis Sanay, head of investor relations. Please go ahead.

Luis Sanay -- Head of Investor Relations

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 investor 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. Jeff Dayno, chief medical officer; Jeffrey Dierks, chief commercial officer; and Sandip Kapadia, chief financial officer. Moving on to slide two. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs.

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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?

John Jacobs -- President and Chief Executive Officer

Thank you, Luis. And thank you, everyone, for joining our conference call today. During the first quarter, we continued to execute on our three-pillar growth strategy with progress across all three pillars and achieving two 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 three pillars of our growth strategy in the context of quarter one 2022 performance. Starting with pillar one, 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's underlying business fundamentals remain 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 two, which is to expand the clinical utility of WAKIX beyond narcolepsy.

This quarter, we reached yet another milestone toward 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 3 Registrational Trial 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 three 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 hyper fascia, weight gain, and other metabolic parameters. Dr. Jeff Dayno will share more on HBS-102 later in this call. And finally, pillar three, acquiring new assets through business development to expand our portfolio beyond WAKIX.

Over time, our intention is to develop a broad portfolio of rare, often 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 waking life cycle. Now, it's important that we're beginning this journey early in our company's 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 three-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 in 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?

Jeffrey Dierks -- Chief Commercial Officer

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 two and a half 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 to the significant unmet medical need in the narcolepsy market. And moving on to slide five, 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 reauthorizations, and Patient Assistance Program reverification, typical for branded specialty products in the first quarter each year. We experience these same seasonal payer dynamics the previous two 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 approval. 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. [Inaudible] one time event, the government pay, and free good patients, we would have experienced similar average patient growth as prior quarters. Moving forward, we're confident in continued growth of WAKIX, marks represented our strongest month of performance and top-line prescription demand, and new patient starts in over a year and provides strong momentum in our business as we head into Q2. [Inuadible] in our Prescriber base, we observed a further broadening and meaningful clinical adoption of WAKIX.

We saw further growth and new prescribers for WAKIX in the first quarter of 2022, both in riders of traditional narcolepsy treatment, as well as healthcare 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 two or more of their narcolepsy patients since launch. We are pleased with the continued growth in both the Depth & Breadth of our Prescriber Base, demonstrating the growing opportunity for WAKIX in adult narcolepsy. We continue to see broad utilization of wages for both Type one and Type two narcolepsy patients, and WAKIX being prescribed as monotherapy, as well as concomitantly with all other narcolepsy treatment.

We saw an increase in in-person field sales engagement with healthcare professionals, and 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 toward 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 wages 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 1st, 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 and underlying business fundamentals of WAKIX in the narcolepsy market affirm our confidence in WAKIX, as being a potential billion-dollar 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 one patient. Increased access to healthcare professional officers for in-person education by our fields sales team, and our expanded field sales team in place, to extend our reach to the broad narcolepsy treating healthcare 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?

Jeff Dayno -- Chief Medical Officer

Thanks, Jeff. And good morning, everyone. I am pleased to provide an update on our clinical development programs, and pillar two of our three-pillar growth strategy to expand the clinical utility of the Pitolisant. First off, as we announced last week, we are excited about the initiation of our phase three 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 six. The primary objective of this trial is to assess the efficacy and safety of the 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 the 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 US will be participating in 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 seven. We have made good progress on our phase two proof of concept trial in patients with proper release syndrome, or PWS, and are on track for top-line data in the second half of this year.

For our phase two trial in patients with Type one myotonic dystrophy, or DM one, 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 one antagonist, as shown on slide eight. 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 hyper aphasia, as well as its impact on weight gain and other metabolic parameters, utilizing an established mouse model of product release 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 timeline 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 programs to a phase three 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?

Sandip Kapadia -- Chief Financial Officer

Thank you, Jeff, and good morning, everyone. This morning we issued our first quarter 2022 press release, and [inaudible] 10-Q, where you'll find the details of our financial and operating results. Our first quarter performance is also shown on slides nine, ten, 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 wages. As expected, we did see the impact of seasonal power dynamics in the early part of the first quarter, resulting in higher growth in 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 the commercialization of WAKIX, and the advancement of our pipeline program. 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 one-time items are excluded. 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 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 31st. During the quarter, we also surpassed $500 million of cumulative net revenue since launch, which triggered a final $40 million milestone payment to our partner via project. Looking ahead, we have strong business momentum, and navigated the earlier pair dynamic, and we expect quarter-over-quarter net revenue growth for the balance of 2022.

We also expect to increase an investment in R&D and SG&A as we continue to successfully execute on our three-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 program and acquire additional assets.

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

John Jacobs -- President and Chief Executive Officer

Thank you, Sandip. In summary, our business fundamentals continue to be strong, putting us in a good position to execute our three-pillar growth strategy and make 2022 our best year yet in company history. Our intent is to continue growing making sales in narcolepsy via a 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?

Questions & Answers:


Operator

Thank you. [Operator instructions] And we'll take our first question from Danielle Brill, with Raymond James. Please go ahead. Your line is open.

Danielle Brill -- Raymond James -- Analyst

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

Thank you.

John Jacobs -- President and Chief Executive Officer

Yeah, Daniel, this is John, thank you for your question. Q1 organic demand for our product was it 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 to add a little bit more color to that, Jeff?

Jeffrey Dierks -- Chief Commercial Officer

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

I hope that answers your question.

Danielle Brill -- Raymond James -- Analyst

Yes. Thank you.

Operator

We'll take our next question from Chris Howerton with Jefferies. Please go ahead. Your line is open.

Chris Howerton -- Jefferies -- Analyst

Great. Hey. Thanks so much for taking the questions. 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 guess the clarification from me, Jeff, you said that the headwinds were from government payors, and patients not meeting assistance for payment. I guess I'm wondering if you can have a little more clarification on that, in terms of the relative demand that you guys just articulated.

John Jacobs -- President and Chief Executive Officer

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

Jeffrey Dierks -- Chief Commercial Officer

Yeah, 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 and we're only in our third year of commercialization, is WAKIX is falling right in the middle of that range, and it's consistent with what the expectations are from patients, from healthcare 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 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 wear some government-insured Medicare patients seek third-party assistance programs to provide financial assistance with insurance premiums, with their co-pay, or coinsurance 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 you know, 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 share to my response to Daniel, 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 start and top-line demand. And we're really optimistic about looking to return to prior quarterly growth and we remain confident that WAKIX is that potential billion dollar 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.

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 these anticipated Q1 dynamics. So just to kind of give you a sense that we're really very, very pleased with our performance and we've got great momentum heading into Q2.

These one-time events are behind us and we've got a great outlook for the rest of [inaudible]

John Jacobs -- President and Chief Executive Officer

And Jeff, 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 businesses is really robust as we go into 2022.

Chris Howerton -- Jefferies -- Analyst

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?

Jeffrey Dierks -- Chief Commercial Officer

Yeah. Chris, we haven't disclosed that information, and honestly, we haven't even looked at that data, but [inaudible] back with you and Brian in a follow-up call.

Chris Howerton -- Jefferies -- Analyst

No problem. I really appreciate it. Thanks again, and great progress everyone.

John Jacobs -- President and Chief Executive Officer

Thanks, Chris.

Operator

And we'll take our next question from Charles Duncan with Cantor Fitzgerald. Please go ahead. Your line is open.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah. Good morning, John, and team. Thanks for taking the question, and congrats on the commercial development progress in the quarter. Let's see, quick question regarding, we've 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 Dierks, sales force expansion, you mentioned second half of the year impact at earliest. I guess I'm kind of wondering why you say at earliest, and how would you best measure that impact?

John Jacobs -- President and Chief Executive Officer

Charles was asking about full year guide post. Did you want to answer that question first?

Jeff Dayno -- Chief Medical Officer

Yeah, sure. Charles, I mean, we're not providing more forward-looking guidance. But what I can say about the business is we've got good, strong fundamentals. You know, you have to get through some of the details, we would expect quarter-over-quarter growth for the balance of the year, both in terms of patient and net sales growth.

So we expect continued momentum that we're seeing certainly coming out of March and going forward. Hopefully, that gives you a little bit of context in terms of our expectations for the year.

John Jacobs -- President and Chief Executive Officer

And Charles, your second question was about sales force impact of our expansion, Jeff Dierks, do you want to handle that?

Jeffrey Dierks -- Chief Commercial Officer

Yeah, absolutely. Thanks for the question, Charles. It's great to hear from you. So as we 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 as 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 target. So what we've shared is about 70% of our interactions are in-person.

So you would anticipate it likely may take six, seven, eight calls for an individual into change of 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 healthcare professionals with the impact of likely new prescription uptake in new patients starts in the second half of the year at the earliest, if that helps.

Charles Duncan -- Cantor Fitzgerald -- Analyst

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

Jeffrey Dierks -- Chief Commercial Officer

Thanks for the question, Charles. In my perspective, I don't see any changes in the Narcolepsy market. 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 the large undiagnosed patient population, the significant unmet need, and really a differentiated product profile for which 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.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Cool. Thanks for taking my questions.

John Jacobs -- President and Chief Executive Officer

Then, 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.

Charles Duncan -- Cantor Fitzgerald -- Analyst

Yeah, thanks. Excited to be here.

Operator

And we'll take our next question from David Amsellem with Piper Sandler. Please go ahead. Your line is open.

David Amsellem -- Piper Sandler -- Analyst

Hey there. So 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 what 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 their 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 one and type two narcolepsy, and actually with Idiopathic hypersomnia, In mind, are you even seeing any evidence of a little bit of label use in IH? Thanks.

John Jacobs -- President and Chief Executive Officer

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

Jeffrey Dierks -- Chief Commercial Officer

Yeah, John, thanks. And David, to your point that the time to getting a prescription filled 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 or specialty pharmacy products in 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 one and type two. So we're seeing about 50% of our new prescriptions coming in for type one narcolepsy, about 50% for type two, 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 one and type two. So, you know, WAKIX really is eligible, and able to be tapping into that broad narcolepsy opportunity. We continue to hear that from healthcare professionals, that WAKIX is an appropriate treatment option for all adult patients living with narcolepsy. And so the data is getting out 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 care. Well, community.

Jeff Dayno -- Chief Medical Officer

Yeah, sure. Hey, David. Thanks for the question. Yeah.

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

David Amsellem -- Piper Sandler -- Analyst

OK. Great. Thanks, guys.

John Jacobs -- President and Chief Executive Officer

Thank you, David.

Operator

We'll take our next question from Karen [inaudible] with Goldman Sachs. Please go ahead. Your line is open.

Unknown speaker

Yeah. Good morning, everybody. I was just hoping that you could expand a bit on the drivers that you saw for new patient growth in March. As you spoke about the strong organic growth if you have any visibility on what are some of the dynamics that are driving that?

John Jacobs -- President and Chief Executive Officer

Jeff, any commentary on that? Because we are 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.

Jeffrey Dierks -- Chief Commercial Officer

Sure. Thanks for the question, Karen. 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 healthcare professionals. So I think that in-person engagement, educating the healthcare 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 healthcare 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 this to make sure they have that optimal experience. So we're really pleased with the momentum that we saw Karen, 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.

John Jacobs -- President and Chief Executive Officer

And 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 WASIX, a continue to prescribe in many of the vast majority of whom become repeat prescribers, correct?

Jeffrey Dierks -- Chief Commercial Officer

Correct.

Unknown speaker

And then to the 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 hand-holding you need to do as you expand your sales force to target, maybe primary care and psychiatrist who aren't writing as much narcolepsy prescriptions or may not have the same experience with the specialty pharmacy?

Jeffrey Dierks -- Chief Commercial Officer

Yeah. I think with a 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 officers 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 touchpoints. 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 worked anticipating a very similar journey with some of these new writers that we continue to bring on board in future quarters.

Unknown speaker

Right. Thank you.

Operator

[Operator instruction] And we'll take our next question from Francois Brisbois with Oppenheimer. Please go ahead.

Francois Brisbois -- Oppenheimer and Company -- Analyst

All right. Thanks for taking the questions. So I was just wondering, just trying to get a better feel for the prevalence of IH. It seems like the true IH patients,18 to 20 hours of sleep are a little more rare, but there seems to be co-mingling of indications.

So it seems hard to visit a lot of patients with IH without the long sleep time. And then there's the narcolepsy type two patients that seem hard to distinguish. I'm just trying to get a feel for how you segment this 30 to 40,000 diagnosed patients in IH that you discuss.

John Jacobs -- President and Chief Executive Officer

Sandip, I want you to take that question from Frank.

Sandip Kapadia -- Chief Financial Officer

Yeah. Good morning, Frank. Thanks for the question. Yeah.

So in terms of IH, I think in terms of epidemiology, it starts with so the claims data, and the number of diagnosed patients. Based on the [inaudible] criteria in the range of 30 to 40,000 patients, I'm going to the literature in terms of the broader epidemiology, it's potentially up to 70 to 80,000 patients in the US. And you raise 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 one narcolepsy, type two, and then IH.

And I think IH, as another central disorder of hyper-somnolence, there is some of that overlap you're alluding to, especially within T-two. However, you lean on the clinical diagnosis, and the clinicians making the diagnosis supported by the sleep studies. And ICST-2 differentiated between IH patients with long sleep time and those without actually the ICST-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 for patients to be eligible. 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 ICST criteria in their clinics as they do with narcolepsy. So we think it's obviously, a significant opportunity for Pitolisant going forward.

As I mentioned before, we're focused on the execution of the interim trial in pursuit of the indication.

Francois Brisbois -- Oppenheimer and Company -- Analyst

OK. Thank you. That's extremely helpful. And then maybe lastly, in terms of the time for the script to be in the patient's hand, has Harmony ever thought, or have ever given out free sample first 30 days, first 60 days of use? or is that's something not necessary based on it not seeming be a problem at this point?

John Jacobs -- President and Chief Executive Officer

Go ahead, Jeff.

Jeffrey Dierks -- Chief Commercial Officer

Yeah, Frank. Thanks for the question. Most of our products do not sample the product, then again, we haven't seen any challenges with the [inaudible] or a patient walking away for not having a sample. Obviously, chronically for neurologic disorder where there is no cure.

Patients have been waiting for over a decade for WAKIX, and so the time that their waiting for their prescription is well, in term of industry norms that we are saying earlier to another question, that I believe David ask, versus benchmark were actually more expeditious in getting patient on product on a lot of other companies. So we're really pleased about the results and the enhancement we're making with our patients our hub in our [inaudible] network. We're really excited about our ability to continue help our patients get on WAKIX.

Francois Brisbois -- Oppenheimer and Company -- Analyst

OK. Great. That's it for me, and congrats on the progress.

John Jacobs -- President and Chief Executive Officer

Thank you, Frank.

Operator

[Operator signoff]

Duration: 42 minutes

Call participants:

Luis Sanay -- Head of Investor Relations

John Jacobs -- President and Chief Executive Officer

Jeffrey Dierks -- Chief Commercial Officer

Jeff Dayno -- Chief Medical Officer

Sandip Kapadia -- Chief Financial Officer

Danielle Brill -- Raymond James -- Analyst

Chris Howerton -- Jefferies -- Analyst

Charles Duncan -- Cantor Fitzgerald -- Analyst

David Amsellem -- Piper Sandler -- Analyst

Unknown speaker

Francois Brisbois -- Oppenheimer and Company -- Analyst

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