Harmony Biosciences Holdings, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Harmony Biosciences first quarter 2021 financial update call. At this time, all participant lines are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star then one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your host today, Lisa Cavarelli, Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's first quarter 2021 financial performance and provide business updates. Before we begin, I encourage everyone to go to the investor section of the Harmony Biosciences website to find the press release and slides that accompany our presentation today, including a reconciliation of the GAAP to non-GAAP financial measures. At this stage of our company lifecycle, we believe non-GAAP financial results better represent the underlying economics of our business. Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Dano, Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Sandeep Kapadia, Chief Financial Officer. Moving 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. At this time, I'd like to turn the call over to our CEO, John Jacobs. John?

Thank you for the introduction, Lisa. And I would also like to thank all of the participants for joining our first quarter 2021 conference call this morning. I am pleased to share with you that once again, we reported strong sales for WCAG with Q1 2021 revenues of approximately $60 million. and achieved profitability for the first time in our company history. We delivered these results despite the lingering challenges of a pandemic and the anticipated seasonal payer dynamics that impact all branded and specialty products in the first quarter, largely due to insurance resets at the beginning of each year. We believe this performance, driven by continued strong demand for Wakex, underscores that Wakex is addressing significant unmet medical needs in the narcolepsy market as our first-in-class, meaningfully differentiated product for people living with this rare neurological condition. Since our inception in 2017, we have focused on developing and marketing novel therapeutic options for people living with rare neurological diseases. Our commitment to these patients has never faltered, and we continue to help an expanding number of narcolepsy patients with WAKIX while making significant progress on our new clinical programs. which are designed to expand the utility of WCAG to new patient populations beyond narcolepsy, including Prader-Willi syndrome and myotonic dystrophy. Harmony's success is driven by our hardworking employees, the patients and healthcare professionals that have embraced WCAG, and the investigators and patients involved in our clinical trials. The momentum we saw in 2020 has continued into 2021. With our robust sales trajectory and strong cash position, Harmony is well positioned to continue to execute on our three pillars of growth this year, which are seen on slide three and include. Pillar one, optimize the commercial performance of WCAG. We reported Q1 net revenues of $59.7 million driven by growth in the average number of patients and the number of healthcare professionals prescribing WCAG since launch. Pillar two, Expand the clinical utility of WCAGGS. By mid-year, we expect to have two phase two programs in the clinic investigating Pitocin for potential new indications. And pillar three, acquire new assets to expand our portfolio. We have a dedicated team which is focused on identifying new assets for potential acquisition within our area of expertise in order to expand our pipeline. We are starting this process early in our company life cycle so we have the time to be thoughtful in our approach and to execute well without unnecessary distraction to our core business with Wayfix. With more than $140 million in cash and cash equivalents on the balance sheet, continued positive sales growth, and now having reached profitability, we are well positioned to act. In summary, I am very pleased with our first quarter performance and look forward to keeping you updated on our progress as we continue to advance our three-pillar strategy to grow the company. I would now like to turn over the call to Jeff Dirks, our Chief Commercial Officer. Jeff?

Thanks, John. I continue to be impressed with the momentum and progress we've achieved through our launch, as indicated by another strong quarter of performance, as noted on slide four. Net revenues for the first quarter were $59.7 million, demonstrating strong performance and representing our fifth consecutive quarter of net revenue growth. Moving on to slide five. For our Q1 commercial results, I'd like to highlight a few key performance metrics. We continue to increase the average number of WACIX patients. In the first quarter, the average number of patients on WACIX increased to approximately 2,800, demonstrating continued strong demand for WACIX and the meaningfully differentiated product profile. The WACIX prescriber base continued to increase, with more than 2,700 unique healthcare professionals have prescribed WAKIX since launch through the end of the first quarter. This represents approximately 33% of the approximate 8,000 healthcare professionals who treat the diagnosed narcolepsy patient population. Market access for WAKIX continues to be strong. We've maintained strong formulary access across commercial, Medicare, and Medicaid insurance plans, and continue to see additional favorable access for WAKIX subsequent to the approval of the cataplexy indication in October of 2020. And with respect to the cataplexy indication, the volume of prescription requests for narcolepsy patients with cataplexy, or type 1 narcolepsy, continued to increase in the first quarter. This growth demonstrates the added value of the cataplexy indication to the overall benefit-risk profile of WAKIX. Additional managed care plans made positive formulary changes for type 1 patients in Q1 building upon the decisions we saw in Q4 2020, further helping to accelerate patients' ability to get access to WAKIX. Now, prior to the approval of WAKIX, we heard through market research from the narcolepsy community that there were a number of unmet needs in the market, and there was excitement for how the differentiated product profile of WAKIX aligned to address those unmet needs. Slide 6 shows what we heard in order of importance. A need for non-scheduled treatment options. WAKES is the first and only FDA-approved non-scheduled treatment indicated for excessive daytime sleepiness, also known as EDS, or cataplexy and narcolepsy. A need for more tolerable treatment options. WAKES has an established safety profile with no box warning and no REMS program. WAKES is not a stimulant with no evidence of drug tolerance or withdrawal symptoms in clinical studies. There is a need for more effective treatment options. In two phase three clinical trials, WAKIX demonstrated a statistically significant reduction in EDS and cataplexy. A need for novel mechanisms of action. WAKIX is a first in class molecule with a novel MOA. The only selective H3 receptor antagonist inverse agonist approved by the FDA. And a need for less frequently dosing. WAKIX offers convenient, patient friendly, once daily oral tablet administration in the morning upon wakening. Now, with WAKIX being on the market for over a year, we wanted to understand how the product was being received and meeting the expectations and the needs of patients and healthcare professionals. We recently commissioned research on behalf of Harmony with 50 narcolepsy-treating healthcare professionals, including those with and without experience prescribing WAKIX, and 30 patients, all with WAKIX experience. Slide 7 shows key insights obtained from the surveyed healthcare professionals. Eighty-four percent of the HCPs surveyed shared that there is a significant unmet need in the narcolepsy market and believe WAKIX offers a unique treatment option for patients. More than 95 percent stated WAKIX is effective for EDS, and more than 90 percent stated it was effective for cataplexy. Healthcare professionals with experience prescribing WAKIX stated even higher perceptions in the effectiveness of WAKIX in EDS and cataplexy than those who had not yet prescribed. and the majority of healthcare professionals surveyed stated their prescribing of WACIX had increased since the cataplexy indication. ACPs stated that WACIX is suitable for the vast majority of narcolepsy patients, and that has increased since the approval of the cataplexy indication, demonstrating that the overall benefit-risk profile offers broad clinical utility for narcolepsy patients. WACIX is being well-received by patients and healthcare professionals view WACIX as having a lower discontinuation rate compared to other approved narcolepsy treatments. And nearly 90% shared that they are expecting to prescribe the same or increase their use of WAKIX in more of their narcolepsy patients in the future. Now moving on to the patient perspective on slide 8. Patient surveys communicated an overall good experience with WAKIX. Patients stated they had a better experience in learning about and accessing the medication than other narcolepsy treatments. Seventy-five percent of patients surveyed share that they believe patients' interest in WAKIX is strong and has even increased since the approval of the cataplexy indication. Eighty percent share that they are likely to tell other people living with narcolepsy about WAKIX, and 90 percent of WAKIX users expect to continue to take WAKIX. The feedback from this market research not only reinforces what we heard prior to the approval of WAKIX, but also demonstrates how the meaningfully differentiated product profile of WAKIX is meeting the unmet needs of the market and highlights the future growth potential of WAKIX. In summary, I'm extremely proud of our first quarter performance. We saw strong growth in revenue and average number of patients, and the market research reinforces the strong future growth potential with WAKIX in the large narcolepsy market opportunity for the 165,000 people living with narcolepsy. I'll now turn the presentation over to Dr. Jeff Dano, our Chief Medical Officer for an update on our clinical development program. Jeff?

Thank you, Jeff, and good morning, everyone. At Harmony, the second pillar of our growth strategy is to expand the clinical utility of pitocin by pursuing new indications in additional orphan rare neurological disorders with unmet medical needs, and by expanding the label in narcolepsy to include pediatric patients. Our current development programs are shown on our pipeline chart as seen on slide number nine. With regard to pursuing new indications in additional orphan rare neurological disorders, all sites have been activated and are currently enrolling patients in our phase two trial in patients with Prader-Willi syndrome, or PWS. This trial is evaluating pitulisant for excessive daytime sleepiness, or EDS, behavioral symptoms, and impaired cognitive function. PWS affects approximately 15 to 20,000 patients in the United States and represents an unmet medical need for which Harmony is committed to pursuing a new treatment option for this patient community. A potential larger market opportunity is highlighted by another one of our development programs, that being in patients with myotonic dystrophy, or DM. which is the most common form of adult-onset muscular dystrophy, and one that is a genetic disorder inherited in an autosomal dominant pattern. Latest estimates suggest a prevalence of about 5 per 10,000 people with a genetic defect for myotonic dystrophy type 1, or DM1, which is the most common form of this disorder. This equates to about 160,000 people in the U.S. with a genetic defect for DM1. Based on the clinical presentation, with 50 percent of this population likely being symptomatic, and of those, about 50 percent being diagnosed, the current number of people diagnosed with DM-1 in the U.S. is approximately 40,000. Of these, 80 to 90 percent experience excessive daytime sleepiness, and over 90 percent also report fatigue. So EDS and fatigue are the two most common non-muscular symptoms in patients with DM1, and they also have a high impact on their daily functioning. There are currently no approved treatments for patients with myotonic dystrophy. As you heard from John and saw in today's press release, we are on track to initiate a Phase II trial in patients with DM1 this quarter. Now let me comment on our program in pediatric narcolepsy. Our strategy with respect to pediatric narcolepsy has always been to achieve pediatric indications for both EDS and cataplexy, and to obtain pediatric exclusivity. As you are aware, our strategic partner, BioPregé, has been conducting a phase three clinical trial, evaluating pitocin in pediatric patients with narcolepsy. Bioprojet amended the protocol and increased the number of patients in the trial, which has pushed out the timeline for trial completion and readout of the data. Together, Bioprojet and Harmony have decided to wait for the readout of the data to inform how best to advance the pediatric narcolepsy program. We believe that our strategic decision to wait for this data before advancing the pediatric program is the most prudent and thoughtful path forward. from a development and financial perspective. In the meantime, we are continuing to evaluate regulatory strategies with regard to obtaining pediatric exclusivity. We remain committed to pediatric patients with narcolepsy and to continue to pursue this indication as well as seek pediatric exclusivity for WACICS. We look forward to providing an update on the status of this clinical program in the coming months. Lastly, I would like to highlight a few key points from data we recently presented at the American Academy of Neurology annual meeting last month and other data that was published in the journal Sleep Medicine earlier this year. These data are from post-hoc analyses of the pivotal data for WACICS that address clinically relevant endpoints and help to enhance the understanding of the product profile of WACICS, specifically related to its efficacy and onset of actions. We conducted post-hoc analyses from the Harmony I and Harmony CTP pivotal trials that examined the efficacy of WAKIX in patients with a high burden of narcolepsy symptoms, both EDS and cataplexy, and looked at the time to onset of response in patients on WAKIX compared with placebo. I will first comment on the high burden analysis, which was published in the journal Sleep Medicine earlier this year. the results from which are seen on slide number 10. High symptom burden for EDS was defined as patients with an F-worth sleepiness scale or ESF score greater than or equal to 16 at baseline. This analysis included 118 patients. The results showed that patients on WAKEX went from an ESF score of 19.0 at baseline to 13.1 at end of the study. compared to patients on placebo who went from 19.4 at baseline to 16.9 at end of study. This finding was both statistically significant and represents a clinically meaningful improvement. High symptom burden for cataplexy was defined as patients with greater or equal to 15 cataplexy attacks per week at baseline. This analysis included 31 patients. The results show that patients on WACIX went from a weekly rate of cataplexy of 23.9 at baseline to 9.4 at end of the study, compared to patients on placebo who went from 23.1 at baseline to 23.0 at end of study, again resulting in a statistically significant and a clinically meaningful improvement in patients with high symptom burdens. This analysis demonstrates that in adult patients with narcolepsy, pitocin is efficacious for improving EDS and reducing cataplexy, even in patients with high symptom burden and severe disease. Moving to slide number 11 and the time to onset of response analysis for WACICS. These data were recently presented at the American Academy of Neurology annual meeting last month. Onset of clinical response was defined as the first time point at which there was a statistically significant difference between pitolisin and placebo. This analysis showed that improvement in EDS and reduction in cataplexy begins at week two after the start of dosing, which is when WACIX demonstrated a statistically significant separation from placebo on both the ESS score and the weekly rate of cataplexy. then continued to improve throughout the duration of the trials. While the prescribing information for WCAG states that it may take up to eight weeks for some patients to experience a clinical response, this analysis shows that the effect of Pitocin may be experienced prior to week eight and as early as week two after the start of treatment. I believe these analyses that we have shared with the medical community focused on clinically relevant outcomes add to the body of evidence in support of the efficacy profile of WAKIX. These data, along with the safety and tolerability profile, as well as its non-scheduled status, results in WAKIX being a differentiated treatment option for both improving EDS and reducing attacks of cataplexy in adult patients living with narcolepsy. In closing, we remain committed to advancing our clinical development programs for pitocin, Based on its unique mechanism of action, we view Pitocin as a portfolio and a product opportunity, and our goal is to optimize the life cycle management plan for Pitocin in the pursuit of new indications in additional orphan rare neurological disease patient populations who are living with unmet medical needs. Thank you, and I will now turn the call over to our CFO, Sandeep Kapadia, who will provide an update on our financial performance. Sandeep?

Thank you, Jeff, and good morning, everyone. I'm excited to have joined Harmony Biosciences and look forward to meeting many of you. Earlier today, we posted our first quarter 2021 press release and filed our 10Q, where you can find details on our financial and operating results for the quarter. I'd like to take the opportunity to share with you some of the highlights from the quarter, which can be seen on slide 12 and 13. I'm pleased to see that the momentum from 2020 has continued into the first quarter of 2021. We grew WCAG sales to our highest quarter to date, managed our operating expenses, and posted our first quarter positive net income and earnings per share. For the first quarter of 2021, Harmony posted 59.7 million in WCAG's net product revenues, as compared to 19.8 million in the prior year quarter. We're pleased with the continued sequential growth of revenues, especially in the first quarter, as there are typical headwinds from insurance reauthorizations and co-pays resetting. We continue to see an increase in average number of patients on therapy during the first quarter, as well as the number of healthcare professionals prescribing WCAGs. For the first quarter of 2021, cost of products sold were $10.4 million versus $3.5 million in the prior year quarter. For the first quarter of 2021, GAAP operating expenses were $34.7 million, up significantly versus the prior year quarter of $26 million. The increase was anticipated as we, in 2020, advanced our pipeline programs in PWS and DM, increased sales and marketing activities associated with the Wayfix launch, and expanded our operations as we became a public company. For the first quarter of 2021, Harmony posted gap net income of $7.4 million, or $0.13 per share. This compares favorably to last year's first quarter net loss of $38.6 million, or $6.30 per share. I'm also pleased with the underlying operating profitability of the business. Harmony reported non-gap adjusted net income of $22.4 million, or $0.38 per diluted shares. Non-GAAP-adjusted net income excludes interest expense, amortization, depreciation, stock-based compensation, and other non-operating items. Non-GAAP-adjusted net income is a non-GAAP financial measure. Please see our press release for a reconciliation of this measure. We also closed the quarter in a strong cash position with $141.2 million. This is down sequentially from year-end 2020, primarily due to the $100 million milestone we remitted to Bioprojet in early January, offset by positive cash flow from operations. So, looking ahead in 2021, we continue to expect to see strong quarter-over-quarter sales growth as we continue to make incremental investments in our pipeline and the launch of WCAGs, all the while maintaining profitability for the year. Finally, a few words on our strategy and approach to business development. After spending the last 12 months focused on ensuring a successful commercial launch of AWAKIX, we are now determined to broaden our pipeline with additional assets that address the orphaned rare neurological disorders. We're taking a disciplined approach to review opportunities ranging from early clinical to commercial with a focus on leveraging our demonstrated clinical and commercial expertise while minimizing disruption in the AWAKIX launch. In addition, We intend to be opportunistic with our existing financial resources while continuing to control our costs. We look forward to providing updates on our business development progress on future calls. So in conclusion, Harmony is in a strong financial position with growing revenues, prudent expense controls, and a healthy balance sheet. As such, we are well positioned to continue to deliver on our three pillars of growth that John mentioned earlier in the call. So with that, I'd like to turn the call back to John for his closing remarks. John?

Thank you, Sandeep, and the entire Harmony team for your continued dedication. In summary, I am very pleased with our continued progress on our three pillars of growth. Q1 was an outstanding quarter, representing our fifth consecutive quarter of sequential revenue growth. We continued to advance our development programs in Prader-Willi syndrome and myotonic dystrophy, Financially, we are in a strong cash position and for the first time in our company history have reached profitability. This success positions us well to pursue our third pillar of growth, acquiring additional assets to expand our pipeline. Operator, we will now take questions from the audience.

Thank you. As a reminder to ask a question, you will need to press star then one on your telephone. To withdraw your question, please press the pound key. Please stand by while we compile the Q&A roster. Our first question comes from the line of David Anselm with Piper Sandler. Your line is now open.

Hey, thanks. So just a couple. So first, I wanted to get your high-level thoughts on more aggressive pay or contracting down the road to the extent you think you need to do it? And the reason I ask is that Jazz has contracted fairly aggressively on Zywave and with some success. Obviously not an apples to apples comparison here, but with contracting in the space, how do you think about your contracting position for Wakex? So that's number one. And then number two is, In terms of the cadence for sales this year, you talked about some headwinds for 1Q, seasonality, things that are customary across the space. With that in mind, can you just talk about what that means for, say, 2Q in terms of moderation of gross to net? Thanks.

All right, Jeff, why don't you take David's first question? Thank you.

Good morning, Dave, and thank you for the question. So with respect to managed care, we're extremely pleased with the favorable market access coverage that we've seen with WACIC since launch. And as we shared in previous calls, we've secured approximately 80%. coverage of all U.S. insured lives across commercial Medicare, Part D, and Medicaid. And since the recent approval of the cataplexy indication, we've seen even additional favorable access for WACICs, building on those that we've seen in Q4. And really what that's doing is either eliminating or reducing some of the step edits for type 1 lives. And so we believe we're very well positioned within the market access landscape to support our patients. We have selectively contracted with a handful of plans that we do not believe that there will be a need for aggressive contracting given the overall benefit-risk profile of WACICs and what we've been seeing in the market. So with that, if that answers your question, I can turn it over to Sandeep and answer the second part of your question with respect to cadence on sales. Go ahead, Sandeep.

Yeah, look, hi. We had a really strong quarter. I was very pleased with, you know, $1,500. 7 million in top line revenue really solid growth versus fourth quarter and certainly versus prior year you know as you mentioned you know typically you have first quarter headwinds which results in slightly higher growth than that in the first quarter you know we obviously see that reversing as we go through the rest of the year and we expect you know strong quarter over quarter growth for the balance of the year so very pleased with how we came out of Q1 and I think you know well positioned for the balance of the year as well hopefully that gives you some color there

Yeah, no, that's really helpful. If I may just ask one more, sneak in one more, just on business development and M&A. Obviously, you've been talking about that for a while. Can you give us a sense of how aggressive you're willing to be in terms of, you know, potential deal size? I know that's a tough one to answer. You're probably looking at a lot of different assets. But, you know, how big can you go for an asset, whether it's commercial stage or pipeline?

You know, David, what I will say is we're determined to broaden our pipeline with additional assets, as you've stated, and we're starting early in our company history so we can take our time to do this thoughtfully, and we want to make sure that whatever we acquire, that it's complementary to what we do now at Harmony, what we know how to do well, and that it allows us internal synergy to leverage our current infrastructure and expertise, and it should be in the rare orphan, neurological, and CNS arenas where we have that infrastructure deployed right now. And certainly we want to make sure that we have the right capability to acquire that, and that's one of the reasons we chose to go public last year. We're in a very strong cash position right now. We have optionality on how to finance a potential deal when we do find the correct deal for Harmony. Okay, that's great.

Thanks.

Thank you. Our next question comes from the line of Chris Howerton with Jefferies. Your line is now open.

Hi, good morning, everybody. Thanks so much for taking the questions and congratulations on the progress this quarter. So I think maybe just a couple questions from me likely mostly related to Jeff Dano. I guess first of all, with respect to myotonic dystrophy, I guess You know, if you could just give us a sense in terms of what does it take to obtain that diagnosis and maybe, you know, if you have some thoughts as to what the shape or trajectory of that diagnosis rate might be when and if, you know, therapies become available for those patients such as wake aches. So that would be question one. And then question two is just with respect to the pediatric narcolepsy study that was described by Bioprojet. Just curious if we could get a little more color. I might have missed it in terms of what exactly the headwinds were to that study, and maybe just a reiteration of what we can know about the timelines at this point. Thank you.

Yeah, sure, Chris. Good morning. Thanks for the question. So with regards to myotonic dystrophy, so the diagnosis is a genetic disorder, and it's inherited in an autosomal dominant pattern. So it's basically a genetic diagnosis. That's how the diagnosis is confirmed. Symptoms include what's called myotonia, so the problems of difficulty muscle relaxing, which results in muscle weakness. But also what we've learned, and as the disorder is more recognized over the years, that EDS, excessive daytime sleepiness, and fatigue are the two most common symptoms non-muscular symptoms in 80% to 90% of those patients. So they come to medical attention and eventually getting to a neurologist, and then the diagnosis is confirmed, as I said, through genetic testing, a defect basically on chromosome 19 of a certain protein. Then with regards to over time, With regards to any disease state, as it becomes more recognized, onset is usually symptoms of late adolescence into early 20s, but then it is a bit of a long journey to diagnosis because there are no approved treatment options for myotonic dystrophy. There are other sponsors working on new treatments, and as we step into this arena, and bring more attention and awareness, I think over time, diagnosis rates will increase. So does that answer your question, Chris, from my time dystrophy?

Yeah, it does. If I might just maybe ask a quick follow-up to that is that I know that at least for many genetic abnormalities, there's newborn screening. So is there any discussion about the potential for that genetic defect to be detected in such a manner?

Chris, it's a great question. It actually is included on some of the newborn screening panels. The latest epidemiologic data that we have actually comes from a large study from the New York State Department of Health and their newborn screening, which is what we cited in terms of, you know, about 150,000 patients in the U.S., you know, potentially with a genetic defect from myotonic dystrophy type 1 or DM1. which is the most common form of myotonic dystrophy. So there is, you know, similar with other rare orphan disorders in terms of genetic screening, there is the opportunity to pick up these genetic defects much earlier in life and then, you know, with greater awareness in the medical community, hopefully leading to earlier diagnosis.

Okay. All right. Very good.

Okay. So turning to... your question about pediatric narcolepsy and BioPregé study with regards to a little more color. So first let me say, you know, we remain committed to patients with pediatric narcolepsy, and it was always our plan to wait for BioPregé's pediatric narcolepsy trial to read out before beginning our own trial. So, Bioprojet's trial is delayed. Basically, they amended the protocol. As I mentioned in my earlier comments, they amended the protocol and increased the sample size and sort of to make the study more robust, and that led to a delay in the readout of the trial. So, you know, along with our partner, Bioprojet, we made a strategic decision to wait for the Phase III trial to read out before initiating our own, which was our original plan. You know, at this point, I think it makes, you know, the most sense to wait for the data before starting another trial and let the data inform us going forward. It could provide us some optionality. You know, we feel that's a prudent approach and thoughtful, and we're working with our partner, BioBerger, to that end. So, you know, we remain committed to the pediatric population obtaining on that indication, and we'll provide an update in the coming months on that program.

Okay. And so at this point, it's difficult to say when those data may become available, and you'll just, that'll be the expected update, maybe?

That'll be the expected update in the coming months, yes.

Got it. Okay. All right. Well, thank you very much, Jeff. Appreciate it.

Thanks, Chris.

Thank you. Our last question comes from the line of Greg Subinavia with Goldman Sachs. Your line is now open.

Hey, good morning, everyone, and thanks for taking my questions, and nice progress with the commercial launch. I had a couple of questions, and thanks for the granularity on some of the details in your slide deck, but if I could just ask on the metrics you provide on The average number of WCAG patients at 2,800, I think that compares to about 2,500 from the last quarter. And then your unique prescribers of 2,700 compares with about 2,400. So just trying to see if I get your perspective on what you think should be a good rate going forward on each of those metrics. And then if I could ask a follow-up question with regards to the patient assistance program, it's been a focus, you know, for some over the past several quarters and given where we are with the recovery or reopening or unemployment, I was just hoping if you could provide some color on the latest update on how you think that dynamic is evolving as it relates to WACIC sales and perhaps getting some sales back that you had perhaps previously lost. Thank you.

Thank you for those questions, Greg. Jeff Dirks, why don't you handle those two for Greg?

Sure. Good morning, Greg. Great to hear from you. So with respect to your first question on average number of patients and unique number of healthcare professionals prescribing since launch, so clearly we're extremely pleased with our continued strong performance in Q1. You know, as we've stated, it was our fifth consecutive quarter of growth in average number of patients and net revenue and number of unique prescribers. And in Q1, we saw a really strong underlying demand, resulting in about a 9% increase in the average number of patients quarter over quarter. You've noted about an 11% increase in the average number of prescribers quarter over quarter. And that growth is seen even with the Q1 seasonal payer dynamics and the lingering pandemic. And we do expect to continue to grow the average number of patients on WACICS and the number of unique healthcare professionals each quarter during 2021. And the research that we recently fielded really shows strong outlook for future growth for WACIX. So the research demonstrated that physicians believe that WACIX is an appropriate treatment option for the vast majority of patients. Physicians shared that WACIX was extremely strong for EDS. Ninety-five percent of physicians stated it was effective for EDS. Ninety percent stated WACIX was effective for cataplexy. And 90 percent of the healthcare professionals expect to prescribe the same or increase their use of WACIX in more of their narcolepsy patients in the future. So I know we're not providing guidance, but we believe that we are going to expect to grow average number of patients and unique healthcare professionals each quarter in 21. So hopefully that helps answer your first question just with respect to, you know, growth moving forward. And then second question you asked about patient assistance program and sort of what have we seen related to, you know, the reopening and a little bit broader COVID vaccination. So, you know, as we shared previously throughout the pandemic, we have seen an increased demand for our patient assistance program. And it's been relatively consistent. And that's even until into the first quarter of 2021. It's difficult to speculate when there will be less reliance on patient assistance as the country continues to open up. We certainly do have a strong conviction to support eligible patients through this program. knowing the difference that WCAG can make in these patients' lives. And importantly, as you've seen, we've been able to demonstrate strong growth in net revenues for five consecutive quarters, even with this elevated demand. And we expect to continue to grow our net revenue and average number of patients throughout 21. Okay, thanks.

And if I could just follow up on an answer you gave previously. When we think about the prescriber's that you've been able to target. As it relates to 2021 and in terms of your ability to do face-to-face interactions with those prescribers, you know, from the 2,700 that you have now, is there a number we should be thinking about as a goal for calendar 2021? I really don't want to give guidance, but I'm just trying to figure out in terms of what that penetration might look like of the 8,000 patients who treat narcolepsy.

No, I appreciate the question, Greg. And our expectation is that we will continue to grow the number of unique healthcare professionals. You know, our 2,700 unique healthcare professionals represents about 33%. of the overall target universe. And so we believe that there's significant opportunity to continue to penetrate that group. We've seen the receptivity to the, you know, the broad clinical utility and the overall benefit-risk profile of WACICS. We have seen, you know, with COVID, there are more healthcare professionals' offices that are opening up and seeing patients. We are starting to see more of our field sales team make more in-person sales calls, and you certainly know the benefit of in-person education, especially in a launch. So while we're not providing guidance, we do expect to grow the average number and the number of unique healthcare professionals quarter over quarter throughout 2021.

Yeah, and Greg, it's Sean. You know, we're optimistic about the opportunity as COVID lifts, as vaccinations continue throughout the United States, and we have yet to really, I think, get a feel for the true run rate. As COVID starts to lift throughout the rest of this year, we'll get a much better feeling for the true run rate. But I think what you've seen here hopefully today and heard from us today is very strong underlying demand. We're getting excellent feedback from physicians and patients on their experience with our product. And there remains tremendous unmet need in this space. This is a chronic disease. These patients are living with this disease before, during, and they will be after COVID. And we're here to help them. And that demand isn't going anywhere. So as we get into the next couple of quarters, I think we'll be excited to share with you the way we're able to penetrate the marketplace as COVID starts to lift.

Okay, thank you very much.

Thank you. There are no further questions. I will now turn the call back to John Jacobs for closing remarks.

Thanks again for joining us today. I hope that you can appreciate that Harmony has continued our strong launch momentum for WACICS and that we are poised well to execute on our three pillars of growth strategy, which should enable us to grow our business and shareholder value as we continue on our mission to help patients who are living with orphan, rare neurological disorders. Thank you.

Ladies and gentlemen, this concludes today's conference call. Thank you for your participation. You may now disconnect.