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 Q1 2022 financial update conference call. All participant lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. If you would like to ask a question at that time, please press star one on your telephone keypad. Please be advised that today's conference may be recorded. Lastly, if you should require operator assistance, please press star zero. 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 Q1 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 life cycle, 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 two. 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 Q1, 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 Q1 2022 performance. Starting with pillar one, which is to optimize the commercial performance of WAKIX. In Q1 2022, 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 Q1 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 two, 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 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 pre-clinical 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. 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 orphan neurology assets and/or assets in 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. 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.
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 Q1 , both in net revenue and underlying business fundamentals. Net revenue for the Q1 was $85.3 million, representing approximately 43% increase from Q1 2021. In the Q1 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 a significant unmet medical need in the narcolepsy market. Now moving on to slide five, I'd like to highlight a few of our underlying business fundamentals that drove our continued growth in the Q1 of 2022.
The average number of patients on WAKIX increased to approximately 3,900 in the Q1 , 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 Q1 each year. We experienced these same seasonal payer dynamics the previous two years of our launch in the Q1 . 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 reverifications 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 one-time events to 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 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. 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 Q1 of 2022, both in writers of traditional narcolepsy treatments as well as healthcare professionals who have been reluctant to prescribe other available scheduled narcolepsy treatments. 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 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 one and type two 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 healthcare professionals and their office staff in the Q1 of 2022 from the Q4 of 2021. More than 70% of all field sales engagements were in person by the end of the Q1 . The increase in access towards the end of the Q1 speaks to an opportunity for further education and engagement in the Q2 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 1st, in line with what we communicated in our last earnings call. We expect to see the benefit of this expansion in the H2 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 Q2 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 patients. Increased access to healthcare professional offices for in-person education by our field sales team. Our expanded field sales team in place to extend our reach to the broad narcolepsy treating healthcare professional universe.
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 programs. Jeff?
Thanks, Jeff, and good morning, everyone. I am pleased to provide an update on our clinical development programs and pillar two of our threee-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 III 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 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 60-80 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 startup activities. We appreciate the efforts of our clinicians and the patients and families in 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 lifecycle management programs for pitolisant, which are shown on our pipeline slide or slide seven. We have made good progress on our phase II proof of concept trial in patients with Prader-Willi syndrome, or PWS, top line data in the H2 of this year. For our phase II 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 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 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. 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 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. Sandip Kapadia for an update on our financial performance. Sandip?
Yeah, good morning, everyone. 2022 press release and filed our 10-Q, where you'll find the details of our financial and operating results. Our Q1 performance is also shown on slides nine, 10, and 11. Show strong year-over-year revenue while continuing to generate cash flow from operations. 2022 and the momentum we're seeing here. For the Q1 of 2022, we reported $85.3 million 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 Q1 , resulting in higher gross and 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 Q1 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 programs. As a result, we had operating profitability improvement as we reported Q1 2022, $0.6 million, compared to $14.5 million in the prior year quarter. Non-GAAP adjusted net income for the Q1 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 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.
Thus, non-GAAP, 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. Quarter of 2022, we generated approximately $29 million of cash from operations and ended $0.5 million in cash and cash equivalents as of March 31st. 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 NA as we continue to successfully execute on our three-pillar growth strategy.
In conclusion, we continue to operate from a position of strength with growing revenues, rooted in 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. With that, I'd like to turn the call back to John for his closing remarks. John?
Thank you, Sandip. In summary, our 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 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?
Thank you. At this time, if you would like to ask a question, please press star one on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing the pound key. We remind you to please pick up your handset and please limit yourself to one question and one follow-up question. We'll take our first question from Danielle Brill with Raymond James.
Hi, guys. Good morning, and thanks so much for the question. I just have a couple clarifying questions on the outlook for WAKIX being so strong. Was this driven by patients with reauthorization delays coming back online, or was this an increase in new prescriptions? Should we be anticipating net patient adds increasing back to the historical 300-400 range moving forward? Thank you.
Yeah, Danielle, it's John. Thank you for your question. You know, Q1 organic demand for our product was actually very strong and stronger than what we experienced in Q4, actually. As we predicted, you know, you have seasonal dynamics in Q1. Why don't I hand your question over to Jeff Dierks to add a little bit more color to that. Jeff?
Good morning, Danielle. With respect to March represented the strongest month in terms of top-line prescription demand and new patient starts. This is new organic demand versus the reauthorization. And 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 2022. I hope that answers your question.
Yep, thank you.
All right, we'll take our next question from Chris Howerton, Oppenheimer.
Great. Hey, thanks so much for taking the questions. I guess similar vein of questioning from 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. In terms of kind of the dynamics moving forward, I guess a clarification from me. Jeff, you said that government payers and patients not meeting 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 wanna take that question from Chris?
Yeah, sure. Thanks for the question, Chris. With respect to durability in terms of the average time on drug, what we're seeing, and we've communicated publicly that, you know, the average discontinuation rate for products in this category at 12 months ranges between 30% and 50%. You know, what we're seeing, although it's still very early and we're only on 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. We're very pleased with, you know, how well the product is being received by the narcolepsy community. With respect to your second question on the dynamics with respect to, you know, the government pay patient, right?
One context is government pay is about, you know, 15% of the overall payer mix. Just to help kinda characterize the size of that opportunity. 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 copay or co-insurance diagnostic test assistance. Through independent data on the annual reauthorization process, 'cause 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. This is anticipated every year. Obviously, it's reflective in our average number of patients on WAKIX for the Q1 .
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. As I kind of shared in my response to Danielle, we're assured 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. We are really optimistic about looking to return to prior quarterly growth. We remain confident that WAKIX is that potential billion-dollar-plus franchise. One thing, Chris, I also wanted to add into, you know, we talk about average number of patients, and they were about 3,900, but we exited the Q1 with approximately 4,100 active patients on WAKIX.
I think exiting Q1, given the anticipated seasonal payer dynamics that we experienced. We have a stronger base of continuing patients. Some of those reauthorizations on refills and new patient starts get pushed into February and March. The rate of average patient growth in the Q1 is slightly less due to these anticipated Q1 dynamics. Just to kind of give you a sense that we're really, you know, very, very pleased with our performance. 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 the year.
Right, Jeff. One of the best lead indicators is the organic demand for our drug was higher in Q1 than it was in Q4.
These are anticipated seasonal dynamics, and the strength of our business is really robust as we move forward into 2022.
That's really helpful. I don't know if you're able to tell us, Jeff, but what was the exit number at the end of Q4 in terms of patients, active patients?
Yeah, Chris, we haven't disclosed that information, and honestly, we haven't even looked at that data.
Okay.
We can circle back with you and Brian in a follow-up call.
No problem. I really appreciate it. Thanks again and great progress, everyone.
Thanks, Chris.
We'll take our next question from Charles Duncan with Cantor Fitzgerald. Please go ahead. Your line is open.
Good morning, John and team. Thanks for taking the question and congrats on the commercial and development progress in the quarter. We talked a little bit about the first quarter. I guess I'm wondering if you can provide guideposts for the full year 2022, given the learnings from the Q1 . Secondarily, maybe for Jeff Dierks, sales force expansion, you mentioned H2 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?
I think Charles was asking about full year guideposts. Did you want to answer that question first?
Yeah, sure. Charles, I mean, as you know, we're not providing what I can say about the business is we've got good, strong fundamentals. You know, Jeff took you through some of the details. We would expect, you know, quarter-over-quarter growth for the balance of the year, both in terms of patients and net sales growth. We expect, you know, continued momentum that we're seeing certainly coming out of out of March and going forward. Hopefully that gives you a little bit of context in terms of our expectations for the year. I think, Charles, your second question was about sales force impact of our expansion. Jeff Dierks, did you want to handle that?
Yeah, absolutely.
Thanks for the question, Charles. It's great to hear from you. 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. You know, we're expecting to see the benefit of this expansion in the H2 of the year simply because we know it takes time to build relationships. Obviously in sort of a COVID depressed environment, it's difficult for us to be able to reach all of our targets. You know what we've shared is about 70% of our interactions are in person. You would anticipate it likely may take six, seven, eight calls for an individual to change a behavior from a prescriber through education.
We're simply just allowing that opportunity, and we're expecting the Q2 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 and new patient starts in the H2 of the year at the earliest, if that helps.
I'm sorry. Go ahead.
No, go ahead please.
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 a commercial effort. Do you see anything changing with regard to narcolepsy market dynamics given Sunosi marketing and then the positioning of WAKIX versus Sunosi? Thanks.
No, 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 2019. You know, it's an active treatment option. We believe WAKIX is growing the branded segment of the market, safety product profile, you know, the only non-scheduled treatment option available, a novel mechanism working through histamine. Given the large undiagnosed patient population, the significant unmet need and really a differentiated product profile for WAKIX, we believe there's plenty of room for multiple branded products. You know, 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.
Cool. Thanks for taking my questions.
Charles, just wanted to welcome you aboard as a covering analyst, and thank you for joining us. It's great to have you here.
Excited to be here.
We'll take our next question from David Amsellem with Piper Sandler. Please go ahead. Your line is open.
Hey, thanks. Just a couple. First, 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 Q1 , and what does that typically look like if you take away the seasonal dynamics. 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 payer hurdles, whether they're seasonal or just more ongoing. That's the first question. Secondly, can you just give us a refresher on the mix between Type 1 and Type 2 narcolepsy?
Actually, with idiopathic hypersomnia in mind, are you even seeing any evidence of a little bit of off-label use in IH? Thanks.
David, 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 product. That's to be anticipated in a rare orphan launch. I think, Jeff Dierks, you may want to add some additional color to that, but we've seen since launch in 2019, a remarkable improvement in that efficiency over time.
Yeah, John, thanks. David, to your point, the time to getting a prescription filled, to your point, we have seen some efficiencies in there. You know, the rates that we're seeing are relatively better than other industry benchmarks when you look at other rare orphan specialty pharmacy products and the time to fill. We don't believe that the time to fill has any impact on abandonment. You know, there is some level of abandonment with every single prescription, whether it's an oral oncology product or a chronic disease. 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.
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. 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. You know, the data is vetting out in there. Maybe I can, you know, ask Dr. Dayno to kind of assist in terms of interest in IH and maybe what we're seeing from the KOL community.
Yeah, sure. Hey, David, thanks for the question. Yeah, in terms of we know that in terms of idiopathic hypersomnia and WAKIX or pitolisant, there's been a lot of interest from, you know, the patient community and the sleep medicine community. We do see, you know, prescription requests in terms of IH, you know, coming into the hub. Obviously, you know, our focus now is on the phase III registrational trial and, you know, doing that study in working towards a potential, you know, new indication for IH. We've been aware of the growing interest in pitolisant for IH and we are, you know, focused on the INTUNE study and doing that registrational trial.
Okay, great. Thanks, guys.
Thank you, David.
We'll take our next question from Corinne Jenkins with Goldman Sachs. Please go ahead. Your line is open.
Yeah, good morning, everybody.
Hi, Corinne.
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.
Jeff, any commentary on there? 'Cause 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. Thanks for the question, Corinne. 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. It was greater in March than it was in February and January. 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. 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. 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. 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.
You know, 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 base who continue to prescribe, and many of the vast majority of whom become repeat prescribers, Corinne.
Correct.
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 and psychiatrists who aren't writing as much narcolepsy prescriptions or may not have the same experience with the specialty pharmas?
Yeah, Corinne, I think with a new product, obviously it's a novel mechanism. There's education within every office. 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.
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 and 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.
Great. Thank you.
Once again, as a reminder, to ask a question today, that is star one on your touch tone phone. We'll take our next question from François Brisebois with Oppenheimer. Please go ahead.
Hi. Thanks for taking the questions. I was just wondering, just trying to get a better feel for the prevalence of IH. It seems like the true IH patients, you know, 18-20 hours of sleep are a little more rare, but there seems to be co-mingling of indications. 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. I'm just trying to get a feel for how you segment this 30,000-40,000 diagnosed patients in IH that you discussed.
Jeff Dayno, why don't you take that question from Frank?
Yeah. Yeah. Good morning, Frank. Thanks for the question. Yeah. In terms of IH, I think it's in terms of epidemiology, you know, it starts with the claims data and the number of diagnosed patients, you know, based on ICSD criteria in the range of 30,000-40,000 patients. Going to the literature in terms of the broader epidemiology, you know, it's potentially up to 70,000-80,000 patients in the U.S. You raise a good point. Obviously, in the sleep medicine community, it's an active discussion. You know, idiopathic hypersomnia exists along a continuum or a spectrum, you know, in terms of patients with Type 1 narcolepsy, you know, Type 2, and then IH.
I think IH as another central disorder of hypersomnolence, you know, there is some of that overlap you're alluding to, especially with NT2. However, you know, you lean on, you know, the clinical diagnosis and the clinicians making the diagnosis supported, you know, by the sleep studies. You know, there, you know, ICSD-2 differentiated between, you know, IH patients with long sleep time and those without. Actually, the ICSD-3 criteria sort of took that away. There is, you know, some of that difference in terms of the, you know, the clinical phenotype. Ultimately, you know, it's how the clinicians make the diagnosis. Obviously, in our clinical trials, you know, we lean on the formal diagnosis of IH for patients to be eligible.
You know, then they're managed in terms of by the, you know, the sleep medicine community. What's also interesting is when speaking to the KOLs, you know, they say that a lot of them have as many patients, you know, with IH, you know, per ICSD criteria in their clinics as they do with narcolepsy. We, you know, think it's obviously a significant opportunity for pitolisant going forward. As I mentioned before, you know, we're focused on the execution of the INTUNE trial in pursuit of the indication.
Okay. Thank you. That's extremely helpful. 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, the 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.
Yeah. François, thanks for the question. Most rare orphan products do not sample the product. Again, we haven't seen any challenges with abandonment or, you know, 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 over a decade for WAKIX, and so the time that they're waiting for their prescription is, you know, well within industry norms. As I was saying earlier to another question that I believe David Amsellem asked, versus benchmarks, we're actually more expeditious in getting patients on product than a lot of other companies. We're really pleased about the results and the enhancements that we're making within our patient hub and our SP network.
We're really excited about, you know, our ability to continue to help patients get on WAKIX.
Okay, great. That's it for me. Thanks, and congrats on the progress.
Thank you, Frank.
All right. Thank you. I am showing there are no further questions. This does conclude today's Harmony Biosciences Q1 2022 financial update conference call. You may now disconnect your line and have a wonderful day.
Thank you, everyone.