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Harmony Biosciences Holdings, Inc. (HRMY) Q2 2021 Earnings Call Transcript

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HRMY earnings call for the period ending June 30, 2021.

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Harmony Biosciences Holdings, Inc. (HRMY 1.03%)
Q2 2021 Earnings Call
Aug 10, 2021, 8:30 a.m. ET


  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Good day and thank you for standing by. Welcome to the second-quarter 2021 financial and business update a conference call. [Operator instructions] I would now like to hand the conference over to your speaker Lisa Caperelli, head of investor relations.

Lisa Caperelli -- Head of Investor Relations

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' second-quarter 2021 financial performance and provide business updates. Before we start, I encourage everyone to go to the investor section of the Harmony Biosciences 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 economics of our business. Our presenters on today's call are John Jacobs, president and CEO; Dr. Jeffrey Dayno, chief medical officer; Jeffrey Dierks, chief commercial officer; and Sandeep Kapadia, CFO. Moving on to Slide number 2, as a reminder, we will be making forward-looking statements today, which are based on our current expectations and belief.

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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. At this time, I would like to turn the call over to our CEO, John Jacobs. John.

John Jacobs -- President and Chief Executive Officer

Thank you, Lisa. And I would also like to extend my sincere thanks to all of the participants for joining our second-quarter 2021 conference call today. We are halfway through the year and I am extremely pleased with the progress our team has made to date. Please allow me to elaborate on our achievements in the context of our three pillars growth strategy, which is shown on Slide 3.

Pillar 1, optimize the commercial performance of WAKIX. Q2 represented a strong quarter for Harmony as we delivered nearly $74 million in net sales for WAKIX and achieved our second profitable quarter in company history. This significant growth of nearly 24% for the prior quarter Q1 was driven by a continued increase in the average number of patients on WAKIX and in the number of healthcare professionals prescribing our product. Both of which further underscores the significant unmet medical need in this market for our truly novel mechanism of action and differentiated product profile, which WAKIX provides.

Moving on to Pillar 2, Pillar 2 expands the clinical utility of WAKIX beyond narcolepsy. And we are excited to now be evaluating pitolisant in two additional rare disease patient populations beyond narcolepsy. Both with significant unmet medical need and where there are no or limited approved therapies. In addition to our Phase II clinical trial in patients with Prader-Willi syndrome that we initiated at the end of last year.

In Q2, we initiated a Phase II trial in patients with myotonic dystrophy. We are also considering additional indications for WAKIX and other rare neurological diseases and we intend to broaden our lifecycle management efforts for this unique product consistent with our strategy for long-term growth. And finally, Pillar 3 acquire new assets to expand our portfolio beyond WAKIX. Through the efforts of our dedicated business development team, I am excited that we acquired our first additional asset beyond WAKIX, HBS-102, which is a potential first-in-class molecule with a novel mechanism of action.

HBS-102 gives us the opportunity to once again lead with the science and narcolepsy and other rare neurological diseases. As you will hear from Dr. Jeff Dayno, we believe that HBS-102 with its unique mechanism of action potentially represents the next generation of targeted therapy for narcolepsy. Beyond those working through histamine and other neurotransmitter systems in the brain including orexin.

We view this acquisition as another important step on our journey to becoming a leading rare neurological disease company. Our business development strategy is intended to transform Harmony into a multi-product company with a robust catalyst rich pipeline of innovative therapies at various stages of development with the potential for launch both during and after the WAKIX lifecycle. An important aspect of this strategy is that we're focusing on assets in the rare neurological arena where we can leverage our existing expertise and infrastructure. Enabling us to optimize development and launch while managing costs, which in turn is intended to create long-term value for our stakeholders.

To further support this initiative and the long-term growth of harmony, we have entered into a strategic collaboration with Blackstone, that gives us access to additional capital while reducing our current cost of capital and enhances our flexibility so we can continue to invest in our growth strategy. Sandip will speak more about this later in the call. On that note, I would like to turn the call over to Jeff Dierks, our chief commercial officer. Jeff?

Jeffrey Dierks -- Chief Commercial Officer

Thanks, John. We saw another strong quarter performance for WAKIX in Q2 as measured by key performance metrics noted on Slide 4. Net revenue for the second quarter with $73.8 million representing almost a 24% increase from the first-quarter 2021. This solid double-digit growth in net revenue was aided by strong prescription demand at the end of the first quarter, that helped to drive additional growth in the quarterly average number of patients for Q2.

Growth in new prescribers of WAKIX and improvement in the gross to net from Q1. That is normal given the impact of seasonal payor dynamics in the first quarter of each year. And moving on to Slide 5, the average number of patients on WAKIX increased 15% from what we reported in Q1 to approximately 3,200 patients. More than two-thirds of these patients are refilling WAKIX prescriptions at the highest dose.

We anticipate that percentage increase over time as more healthcare professionals gain valuable clinical experience with their patients. And see the benefits of the product in treating the debilitating and life-impacting symptoms of excessive daytime sleepiness or cataplexy. The growth in the average number of patients on WAKIX demonstrates continued strong demand despite competitive products entering the market. And also speaks to how the meaningfully differentiated product profile aligns with the unmet needs of the narcolepsy market.

Our strong commercial performance continues to be driven by the following key factors. First, we continue to see broad and meaningful clinical adoption of WAKIX. We saw continued growth in the prescriber base of WAKIX in Q2. Of the more than 8,000 healthcare professionals who treat the majority of the diagnosed narcolepsy patient population.

Over 38% have prescribed WAKIX since launching through the end of the second quarter. We also continue to see the vast majority of those prescribers becoming repeat writers with two or more of their narcolepsy patients receiving a prescription for waking since launch. Patients' feedback from the community continues to demonstrate positive experience and a strong interest in the product. Second, the already strong market access for WAKIX was further strengthened with an increased number of plan making additional positive formulary decisions for narcolepsy patients with cataplexy.

Over 80% of all US-covered lines have favorable access to WAKIX. And the recent positive formulary decisions for Type 1 patients within these plans, which help to take some of the friction out of the managed care workflow approval process. Patients' ability to access to WAKIX has been accelerated in the second quarter. Third, we saw improved access to healthcare professionals for our field sales team.

ZS access monitor data showed that by the end of the second quarter nearly two-thirds of all field sales engagements with healthcare professionals were in-person. Providing more of a meaningful education exchange for branded products and newer products still in the launch phase. We saw a corresponding increase in WAKIX top-line prescription demand that aligns with the opening of the country. As more healthcare professionals are seeing patients in person and more face-to-face interactions are occurring between healthcare professionals and our field sales team.

And lastly, WAKIX offers a meaningfully differentiated product profile. The broad and strong adoption of WAKIX speaks to the significant unmet need in the narcolepsy market and how the overall benefit-risk profile of WAKIX aligns with the unmet needs. Despite the growing competitive landscape of products, WAKIX offers a truly unique option for healthcare professionals and patients as seen on Slide 6. WAKIX offers a first-in-class molecule of a novel MOA, the only product that works through histamine.

WAKIX is the only non-scheduled treatment option indicated for both excessive daytime sleepiness or cataplexy in narcolepsy. WAKIX is not a stimulant, with no evidence of drug tolerance or withdrawal symptoms in clinical studies. WAKIX can be used as monotherapy or administer concomitantly with other narcolepsy treatments with no clinically relevant pharmacokinetic interactions. With either modafinil or sodium oxybate demonstrated in clinical trials.

And WAKIX offers convenient patient-friendly once-daily oral tablet administration in the morning upon wakening. I am extremely encouraged by our continued strong performance of WAKIX in the narcolepsy market. Further reinforcing our perspective that WAKIX offers a unique and meaningful option to treat both excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. I'll now turn the presentation over to Dr.

Jeff Dayno for an update on our clinical development program. Jeff.

Jeffrey Dayno -- Chief Medical Officer

Thanks, Jeff, and good morning, everyone. I'd like to start by speaking to our updated pipeline chart on Slide number 7, as John mentioned we have made significant progress on all three pillars of our company growth strategy. Specifically with regard to Pillar number 2 and our lifecycle management programs for pitolisant. At the end of June, we initiated our Phase II clinical trial to evaluate pitolisant in patients with Type 1 myotonic dystrophy known as DM1.

In addition, our Phase II trial in patients with Prader-Willi syndrome or PWS continues to advance with patients completing the randomized controlled phase and rolling into the open-label extension phase of the trial. Both trials are on track for top-line data readout next year. But the real exciting news for us today is the acquisition of our first product beyond WAKIX HBS-102, which represents an innovative drug development opportunity that could enable us to potentially bring another new first-in-class therapy to patients living with narcolepsy and possibly other rare neurological diseases. HBS-102 is a potential first-in-class molecule with a novel mechanism of action that targets melanin-concentrating hormone known as MCH neurons in the brain.

Scientific evidence suggests that MCH neurons function as a control center and driver of REM sleep and its related behaviors. Let me start with Slide number 8, which explains the control centers for sleep and wakefulness that are centered in the hypothalamus. The main mediators of wakefulness and sleep-wake states stability are orexin and hypocretin, produced in the lateral hypothalamus. As well as histamine produced nearby in the tuberomammillary nucleus or TMN.

The main driver of non-rapid eye movement sleep or non-REM sleep is GABA, which is produced in the ventral lateral preoptic nucleus or VLPO. And the main generator of REM sleep is a melanin-concentrating hormone known as MCH, which is produced in a diffuse network of neurons in the lateral hypothalamus interspersed among the orexin neurons. Similar to how orexin and histamine neurons drive the wakefulness component of sleep-wake states stability, MCH neurons drive REM sleep and its associated behaviors. Moving to Slide number 9, which shows the opposing roles of orexin and MCH related to sleep wake's function.

The panel in the top left depicts how one of the original models of narcolepsy was explained in an orexin deficient state that occurs in patients with Type 1 narcolepsy. There is an imbalance between orexin and GABA, such that GABA goes unchecked, which results in sleep intruding into wakefulness that patients experience as excessive daytime sleepiness or EDS. The panel on the top right depicts a similar kind of imbalance in an orexin deficient state related to the REM control center. Or in an imbalance in MCH that causes REM intrusion into wakefulness that patients experience as the symptoms of cataplexy, hallucinations, and sleep paralysis.

The figure at the bottom depicts the therapeutic hypothesis for HBS-102. Based on its mechanism of action working as an MCH receptor 1 antagonist HBS-102 will block the activity of the MCH neurons to restore the balance between MCH and orexin signaling decreased REM overdrive, decreased REM intrusions into wakefulness, which will then potentially result in decreased symptoms of cataplexy, hallucinations, and sleep paralysis. Moving on to slide number 10, preclinical proof of concept of the MCH receptor 1 mechanism of action has been established in an orexin knockout mouse model of narcolepsy. This model has good clinical predictability in patients with narcolepsy.

This experiment was conducted by Dr. Tom Scammell and his team at Harvard. The graph on the left shows the number of cataplexy attacks and the one on the right shows the number of short-latency transitions into REM sleep labeled SLREM, which is an electrophysiologic correlate of sleep-wake state instability and REM intruding into wakefulness. In orexin knockout mice at baseline, those treated with vehicle had significantly more attacks of cataplexy and balance of bouts of SLREM compared to those treated with an MCH receptor 1 probe molecule, which in this experiment with SNAP 94847.

When the mice were fed chocolate, which excites them and provides a positive emotional stimulus the number of cataplexy attacks increased as did the bouts of SLREM. But the MCH receptor 1 antagonist blocked these events to a similar degree as was seen during the baseline condition. This preclinical proof of concept data is impressive and it's part of our next steps, which are included on Slide number 11. We will look to replicate this data with HBS-102 in the orexin knockout mouse model of narcolepsy.

In addition, we will work to prepare and submit an investigational new drug application with the plan to initiate a Phase II clinical trial once our IND is open. We will provide additional updates on the development plan for HBS-102 on future calls. As John stated, this acquisition is an important step in our ongoing mission to become a leading rare neurological disease company with an innovative product portfolio. Having gained FDA approval for one first-in-class product with a novel mechanism of action we now have the opportunity to once again lead with the science and develop a second first-in-class molecule with a novel MOA for patients living with narcolepsy.

This is consistent with our commitment to advancing breakthrough science and addressing true unmet medical needs in patients living with rare neurological diseases. My team and I are excited to go to work on the HBS-102 development program. With that, I will now turn the presentation over to Sandip Kapadia to review our financials. Sandip?

Sandip Kapadia -- Chief Financial Officer

Thank you, Jeff, and good morning, everyone. This morning we're announcing our strategic financing collaboration with Blackstone. And issued our second-quarter 2021 press release and filed our 10-Q where you can find the details of our financial and operating results. So let's start with the strategic financing collaboration with Blackstone, which includes $330 million of capital as seen on Slide number 12.

As you may know, Blackstone is a premier global investment firm with strong transactional experience and providing capital to life-size companies to help further develop, expand, and commercialize their portfolio. This transaction is meaningful to Harmony as it provides up to 200 million of debt capital to pay off our existing loan at a considerably lower interest rate, which will result in an annual interest savings of approximately $10 million. In addition, Blackstone will also provide up to 100 million in capital as we look to expand our pipeline by acquiring and licensing products beyond WAKIX and HBS-102. And finally, the financing also includes a 30 million equity investment in Harmony common stock.

We're thrilled that such a fund as Blackstone has chosen to collaborate with us to support our future growth. So moving onto our second-quarter performance on Slide 13 and 14, in the second quarter we again posted our highest quarterly net revenues to date. With effectively managing our investments and posted our second consecutive quarter with positive net income and earnings per share. I'm pleased with the continued momentum we're seeing.

For the second quarter of 2021, we reported 73.8 million in WAKIX net product revenue as compared to 38 million in the prior-year quarter. This represents the growth of 94.2%. As Jeff pointed out earlier this is also a 23.7% increase from Q1 2021 where we have 59.7 million in revenues. We're pleased to see the continued growth in the average number of patients and the number of healthcare prescribers.

The second-quarter 2021 gross margin was 61.1 million versus 31.5 million in the prior-year quarter. For the second-quarter operating expenses reach 37.8 million versus the prior quarter of 24.2 million. The growth in operating expenses resulted from our continued commercialization of WAKIX and the advancement of our pipeline programs. As a result, we posted a second-quarter 2021 net income of $14.1 million for $0.24 per diluted share.

This compares favorably to a net loss of $10.5 million or a loss of $1.34 per share in the prior-year quarter. The underlying operating profitability improved as well. We posted a second-quarter non-GAAP adjusted net income of $31.9 million or $0.54 per share versus the prior-year quarter net loss of $0.5 million or $0.7 per share. 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 ended the second quarter in a strong cash position, but 159.7 million in cash up sequentially from Q1. As we look forward to the second half of 2021, we anticipate continued quarter-over-quarter growth in revenue with normal seasonality during the summer period as well as increased investment for R&D and SG&A.

We believe the WAKIX launch has been quite successful today and we're focused on driving continued WAKIX growth as well as expand into additional indications that address rare neurological diseases. We're also very excited about the acquisition of HBS-102. We've been able to be financially prudent in acquiring this early stage asset with minimal upfront and success-based future milestones. This approach allows us to maintain a strong cash position while focusing resources on advancing the clinical program.

In the future, assuming success we'll be obliged to make developments, regulatory, sales milestone payment in addition to tiered royalty and the single to low double-digit range. As an early asset, we expect nominal increases in our R&D until we advance HBS-102 in the later stage of clinical development. So in conclusion, we're operating from a position of strength as we have a strong balance sheet, access to additional capital, growing revenues, an expanding product pipeline, prudent expense control, and opportunity to expand in rare neurological diseases. As we continue to generate revenues and maintain profitability at the WAKIX franchise, we will look forward to reinvesting this capital to fund our ongoing development program and acquire additional assets.

So 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, Sandy, and thanks to the entire Harmony team. Harmony is delivering on all three pillars of our growth strategy and with the success of this most recent quarter, we've taken another crucial step forward on our journey to become a leading round or a logical disease company with an innovative pipeline of products. I'm excited about the potential we are building to deliver even more hope and life changing results to patients in the future. In summary, the second-quarter 2021 represented our sixth consecutive quarter of sequential earnings growth and our second sequential quarter of profitability.

Our development pipeline continues to grow and expand. In addition to our Phase II Prader-Willi trial, we initiated a Phase II trial in myotonic dystrophy with WAKIX and acquired the rights to HBS-102 a novel first-in-class molecule. In addition, we have further strengthened our balance sheet and enhanced our flexibility to execute on pillar three of our growth strategy by gaining access to additional financing through the Blackstone collaboration. Operator, we will now open the call to questions from the audience.

Thank you.

Questions & Answers:


[Operator instructions] Our first question comes from Chris Howerton with Jefferies.

Chris Howerton -- Jefferies -- Analyst

Excellent. Congratulations on the great progress this quarter to you John and the team.

John Jacobs -- President and Chief Executive Officer

Thank you, Chris. Thank you for joining our call.

Chris Howerton -- Jefferies -- Analyst

Of course. All right. So I guess maybe just a couple of questions from me and congratulations also on the acquisition of 102. It's really interesting.

But first maybe on the commercial side perhaps for Jeff Dierks. Could you give us some color on what you're seeing currently on patients on the free drug? Or the patient assistance programs that you've described in previous quarters and just kind of maybe what you're seeing relative to what you observed previously there? And then, the second question I have is perhaps related to the other Jeff for 102. I just -- I guess I'm curious how you're seeing the unmet needs specifically for the REM-related symptoms? Such as hallucination, cataplexy, and sleep paralysis. And kind of what segmentation of the narcolepsy market do you see that serving.

Thank you.

John Jacobs -- President and Chief Executive Officer

Thank you, Chris. Go ahead, Jeff Dierks. Why don't you take the first question?

Jeffrey Dierks -- Chief Commercial Officer

Sure. Thanks for the question, Chris. So as you stated before throughout the pandemic we have seen an increased demand for our patient assistance program. And that elevated demand has been relatively consistent even into the second quarter of 2021 where the COVID limitations had started to subside.

And that's difficult to speculate as to when there'll be less reliance on the patient assistance program as the country continues to deal sort of with the ongoing challenges of COVID. But I think the important key takeaway here is that even with this elevated demand we've been able to demonstrate strong revenue growth. And continue to see that strong underlying organic demand for WAKIX giving us continued confidence and a long-term growth outlook for the brand.

Chris Howerton -- Jefferies -- Analyst


John Jacobs -- President and Chief Executive Officer

Go ahead, Dr. Dayno. Why don't you take the second?

Jeffrey Dayno -- Chief Medical Officer

Sure. Yeah. Good morning, Chris. Thanks for your question.

So with regards to HBS-102 and the target of REM this regulation in general. As cataplexy is the most common of those symptoms with regards to REM dysregulation and REM intrusion into wakefulness. But the potential for a specific therapy targeted at all of the symptoms so the combination of cataplexy as well as sleep paralysis and hallucinations. Because of the variability of those symptoms in the patient population with narcolepsy.

So we feel that potential new therapy with that specific mechanism targeting REM dysregulation in general, would have significant potential significant value and utility.

Chris Howerton -- Jefferies -- Analyst

Yeah. And I guess I mean if I could just ask a clarification. So I guess and Jeff, would you view this as an adjunctive therapy to maybe existing therapies that a patient has managed to own? Or would this be sufficient as a monotherapy in a certain amount of patients?

Jeffrey Dayno -- Chief Medical Officer

So Chris, in addition to the proposed mechanism in the development program, we're also going to evaluate with regards to the overall potential effect on sleep-wake state stability and the imbalance between the orexin signaling and the MCH neurons. We're going to assess it also for the ability to stabilize wakefulness and the potential to improve EDS as well. So as we build out the development program we're looking at both utility and effectiveness for REM dysregulation and the potential also to stabilize wakefulness and address EDS. So I think, that is the potential opportunity either as a monotherapy or potentially as concomitant therapy with other treatment.

John Jacobs -- President and Chief Executive Officer

Well said Dr. Dayno. And it's John, Chris, one of the things we all know about the narcolepsy market is that there's a polypharmacy market and there's a significant level of unmet and need complexity with these in these patients. And having a unique mechanism of action that comes up in this condition from a completely different target than anything else on the market could facilitate polypharmacy utilization there.

And be a benefit to patients on top of existing therapies whether they be branded or generic.

Chris Howerton -- Jefferies -- Analyst

Yeah.. Very good. Well thanks for all the color and very excited to see the progress there. Thanks.

John Jacobs -- President and Chief Executive Officer

Thank you.


Our next question comes from Graig Suvannavejh with Goldman Sachs.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Hey. Good morning, team. Thanks so much for taking my questions and congrats on the quarter.

John Jacobs -- President and Chief Executive Officer

Thank you.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Maybe if I could ask a forward-looking question for some of my commercial stage companies. They've made some proactive comments on how they're monitoring COVID and the evolving Delta variants. Could you provide any color on how you are thinking about whether it's moving from second quarter and third quarter? And perhaps just overall comments on what you're seeing about the second half? Or how you're feeling about the second half? And so that's my first question. I probably have 17 questions but I won't have 17.

But let me add that first one. Thanks.

John Jacobs -- President and Chief Executive Officer

We'll pick them one at a time, Graig. If that's helpful. So why not -- with the first one. I mean obviously, Harmony has shown our ability to execute on the launch and commercialization of WAKIX despite facing immense headwinds that all of our colleagues, and patients, families, and co-workers experienced last year and into the beginning of this year.

And as COVID started to lift there's a direct correlation with that left in the opening of offices for traffic increasing with patients into those offices and therefore potential uptake of prescriptions including WAKIX and you saw some of that momentum here in Q2 with our strong results. It's hard to predict what might happen with COVID, but let me handed over to Jeff Dierks. And Jeff if you wanted to add some commentary to that and what we're thinking about the second half.

Jeffrey Dierks -- Chief Commercial Officer

Yes, sure, John. Thanks for the question, Graig. And to reiterate what John shared in the second quarter we did see more physician offices opening we have greater in-person educational engagement from our field sales team. More patients coming back into the office for in-person medication management visits.

And there certainly is a correlation in terms of the increase in the WAKIX top-line prescription demand that we saw in Q2 aligning with the opening of the country. And I think that speaks to the unmet medical need that we talk about and really how the meaningfully differentiated product profile of WAKIX aligns with that need. And as John shared, we're seeing strong momentum in our business. We see a very strong underlying organic prescription demand.

I think it's very difficult to speculate forward-looking, Graig, with respect to the impact of the current resurgence. Or the summer seasonality on the industry of WAKIX and the exact growth rates that we're going to see moving forward. But I will reiterate that we're extremely encouraged by the continuing underlying strong demand that we're seeing the strong performance of WAKIX. And we do expect to continue to grow quarter-over-quarter as we've demonstrated growing through the pandemic previously.

John Jacobs -- President and Chief Executive Officer

Yeah. And perhaps Sandip Kapadia, our CFO. Sandip, did you want to add some additional color to that?

Sandip Kapadia -- Chief Financial Officer

Sure. I think just in addition to what Jeff said. We anticipate a continued quarter-over-quarter growth for the second half of the year. Obviously, there's general summer seasonality that typically happens as well.

But generally, we feel good about the trends that we're seeing especially very strong Q2 that will certainly carry forward for the balance.

John Jacobs -- President and Chief Executive Officer

Thank you, Sandip.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Maybe as a follow-up. I've heard you discuss or bring up the summer seasonality phenomenon. And I'm wondering, historically speaking, maybe because I'm losing brain cells these days. Like, I don't remember how summer seasonality might have either impacted WAKIX last year, although you were in much earlier in your launch.

Or what you've seen historically given the management teams prior experience with these types of products during the summertime.

John Jacobs -- President and Chief Executive Officer

Good question, Graig. As last year was there was an unusual year with COVID and it was also our first year of launch. So unfortunately we didn't have several years of history prior to that to be able to give you something to anchor that off -- upon. And we believe last year was skewed due to COVID.

So it's really hard to say. Jeff Dierks anything to add to that or Sandip.

Jeffrey Dierks -- Chief Commercial Officer

Yeah. I would just say overall, Graig and in any given calendar year there is seasonality in the first quarter. There's usually the seasonal payor dynamics that occur and put pressure on gross to nets in the reauthorization of prescriptions. Second quarter is usually followed with strong uptake.

Third quarter you see that traditionally people taking vacations, right? There's fewer representative and healthcare professional interactions, fewer patient visits to the office, and then that's followed usually by a strong fourth quarter. Patients filling their prescriptions before the end of the year and their insurance changes. You've got pharmacies looking to make sure they've got adequate stock and supply for the holidays. So we're anticipating to have an element of that industry phenomenon with the Q3, but again it's very difficult to speculate.

We see very strong underlying organic demand. We're very confident our continued growth in the average number of patients and net revenue Sandip talked about.

John Jacobs -- President and Chief Executive Officer

Thank you, guys.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Thanks for that color. Maybe if I could ask the question about the Blackstone deal. Certainly, the size of the deal is noticeable. It's great that you can swap out I guess affects the more expensive debt you put that.

But in terms of your already profitable, you're generating good cash flows and certainly building to the balance sheet and in the context of the BD transaction, you announced yesterday, which I have a follow-up question on. How should we be thinking about kind of how that war chest that you're amassing in terms of cash? How you plan to use that? Is it really more with an eye on funding in other trials that you have ongoing? Or should we be thinking that that is really perhaps a sign of things to come in terms of increased BD activity? Whether it's the number of deals or the size of the deals?

John Jacobs -- President and Chief Executive Officer

So, Graig, as you stated we're in a strong cash position about 160 million in cash and cash equivalents on hand, a strong balance sheet, and generating positive revenue. But we do see the recent arrangement with Blackstone does provide us with additional flexibility to potentially enable execution on a broader range of deals. Business development deals that align with our strategic criteria and are a key component of our three pillar growth strategy. And just as a reminder, that strategy includes the continued growth of WAKIX and commercialization of WAKIX.

The expansion of utility of WAKIX is beyond narcolepsy into new indications and the acquisition of additional rare neurology-focused assets so we can build a rich and innovative pipeline. And especially a pipeline with assets that could launch at different stages from during WAKIX lifecycle to after. And importantly, Graig, we have the capabilities on our team. We built Harmony with a focus in rare neurology and our intention is to transform Harmony into a leading rare neuro company with a robust and innovative pipeline.

That is our intention and the arrangement with Blackstone helps to give us additional flexibility to head down that strategic pathway with helpful success.

Graig Suvannavejh -- Goldman Sachs -- Analyst

Great. Thank you for that. One last question. Broad area questions.

I guess have to do with HBS-102. An interesting asset and an interesting mechanism of action. I think historically the industry has looked at this asset for perhaps the past couple of decades with efforts initially and in the obesity space. So with that in mind, can you give a sense of whether your interest in narcolepsy is relatively new and kind of innovative? I don't think I've seen much in the literature on this mechanism necessarily.

Recently the interest by industry on the obesity side. And then secondly, just as it relates to the compound itself. I think these classes of compounds have been seemed to have troubles finding a therapeutic window or therapeutic margin. I think the issue has been increased potential cardiovascular risks due to either [Inaudible] binding activity or QTC prolongation.

So I'm just curious if you've characterized HBS-102 for these types of issues and how companies you feel about the overall profile of the asset? Thanks.

John Jacobs -- President and Chief Executive Officer

Graig , two-part question Dr. Dayno will help address that. But we're excited about the emerging science around this target and this compound as it relates to sleep and run behavioral disorder and narcolepsy as Dr. Dayno stated in his opening comments.

But I'll pass it over to Dr. Dayno to address your questions in more depth.

Jeffrey Dayno -- Chief Medical Officer

Yeah. Sure, John. Yeah. Good morning, Graig.

So we're actually we're really excited about this asset. And as John alluded to on the emerging science with regards to the MCH neurons in that mechanism of action. And as you said the original focus around obese -- obesity hypothalamic mediate obesity, but as this science evolved and on some significant work. As I mentioned done by Tom Scammell and his group at Harvard it really pointed to the role of the MCH neurons in terms of the generator and the control center of REM sleep.

So with that, going back about four or five years ago a lot of the focus shifted and Tom Scammell and his lab worked on that mechanism. And demonstrated with MCH receptor 1 antagonist pro molecule this significant effect in reducing cataplexy seen in the orexin knockout mouse model. So with that, the focus sort of shifted and that's what kind of got our attention and realizing some of the recent focus on the orexin agonists. This really represents the potential next generation therapy in patients with narcolepsy specifically around REM dysregulation.

And as I mentioned before, in our development program in addition to that we intend to explore it for stabilizing wakefulness as potential monotherapy. Or as one type of treatment in a polypharmacy approach. With regards to this molecule and what you mentioned in terms of some of the safety issues the non-clinical toxicology and the work that's been conducted has not shown any significant safety signals on today. And we also have some Phase I PK data that's been generated actually at US and in the UK showing that PK profile.

So we've got a lot of information to work with to start to prepare an IND and submit that to then open an IND. And the plan is to then go into Phase II trials.

Graig Suvannavejh -- Goldman Sachs -- Analyst

OK. Thank you very much. Congrats and then all the progress.

Jeffrey Dayno -- Chief Medical Officer

Sure. Thank you.


[Operator instructions] Our next question comes from David Amsellem with Piper Sandler.

David Amsellem -- Piper Sandler -- Analyst

Hey. Thanks. So I had a few. First, can you comment on patient attrition for WAKIX? I think in the past you stated that the range in narcolepsy is about 30% to 50%.

Where is that is trending for WAKIX? And assuming greater societal normalization Delta variant notwithstanding. Where do you see that attrition rate settling out? So that's number one. Number two, can you talk about the mix of patients who are taking WAKIX in combination with an oxybate product? What percentage of overall patients is that are you seeing more combination use with oxybate? Third, as the market becomes more varied particularly as we get to authorize generics and eventually vanilla generics of sodium oxybate. Do you think you'll need to contract more aggressively with payers? Or recalibrate your payor strategy in any way.

Just talk about over the long term. How you expect to manage the payor dynamics? So just one of those two and then I have a follow-up. Thanks.

John Jacobs -- President and Chief Executive Officer

OK. David. So all three apply to commercials. So, Jeff Dierks, did you want to take the first question on attrition rate.

Jeffrey Dierks -- Chief Commercial Officer

Sure. Thanks, David. So with respect to discontinuation rate, compliance, and persistency rate, so as you shared in previous calls we have looked at publicly available data, which suggests that the discontinuation rate of drugs in this category tends to range between 30% and 50% with compliance rates in the industry usually around 80% to 90%. And what we're seeing is that WAKIX is falling within that range and that's been relatively consistent with other products in the category.

Some of the research that we've done with patients and with healthcare professionals is that the physicians that we've surveyed believe that WAKIX has a lower discontinuation rate. Or a low discontinuation rate relative to other narcolepsy treatments from the patient perspective. We're seeing about 90% of those patients on WAKIX expecting to continue to take the product. So very strong persistency rates, discontinuation rates are very consistent with where we're seeing in the category.

Now again, it's still early our launch where we're not even two years into commercial so we're still going to obviously be observing that patient-medication behavior moving forward. And again, I don't want to speculate in terms of what the impact of COVID may or may not be on the discontinuation rate. But I think the overall takeaway is patient receptivity seems to be very strong. We're getting very positive feedback from the patient community.

The perceptions of healthcare professionals is that WAKIX as well within the norm and at the lower end of their patient medication behavior and we're getting really positive feedback from the community.

John Jacobs -- President, Chief Executive Officer, and Director

Thank you, Jeff. I believe the next question from David is, what's the mix with sodium oxybate? How often is WAKIX to use in combination. David, if I understood?

David Amsellem -- Piper Sandler -- Analyst


Jeffrey Dierks -- Chief Commercial Officer

Yes. So with respect to source of business we've talked a lot about the opportunity with WAKIX as being a novel MOA and having the ability to be used as monotherapy or concomitantly with all narcolepsy treatment options. And that's what we see in a polypharmacy type of categories. That WAKIX is being used as monotherapy and being used in clinical practice in combination with all other FDA approved narcolepsy medication.

With respect to the use of WAKIX and sodium oxybate there's a small percentage of patients are using both. We haven't disclosed the exact figure, but if you're thinking about in the low teens is probably where we're looking. And the important thing is that from a pair dynamic we're not seeing any plans providing any pushback or feedback. This is a very small patient population there's a small cohort of patients that may require this combination to treat the very debilitating and life altering symptoms of narcolepsy.

So hopefully, that helps give you a little bit of color in terms of the patient disposition of WAKIX .

John Jacobs -- President and Chief Executive Officer

And, Jeff, you mentioned our unique mechanism of action for WAKIX as the only histamine medication in the market for narcolepsy and we anticipate it to remain so for quite some time. So as new products come in or generic sensations occur of existing MOA therapies we believe and we're optimistic that WAKIX stand-alone in its ability to be unique and differentiated. And that there's more pressure on products with the same mechanism of action when you start to see generics in general as a market generalization. And we're optimistic that WAKIX unique MOA will help us to remain differentiated for the long run.

Jeffrey Dierks -- Chief Commercial Officer

Correct. And David, I know you're your last question was with respect to just introduction of new products and authorized generic. Or generic versions of sodium oxybate and potential impacts on uncontracted. So what I would say to that is we continue to be extremely pleased with our strong performance of WAKIX even with the introduction and availability of other competitive products today.

And those are both branded and generic. And we do believe, that we are growing the branded segment of the market by offering a meaningfully differentiated product profile that align to that unmet need. The overall benefit risk profile WAKIX makes it appropriate for the vast majority of patients. And available for the entire narcolepsy prescribing healthcare healthcare professional universe due to its non-scheduled status.

As John talked about this threshold to treat makes it available for the broad audience to prescribe and we believe this strong underlying demand that we see with WAKIX will continue. And support our ongoing patient and net revenue growth even with new competitive entry both branded and generic coming to the market. And it really supports our belief in the long-term growth opportunity for WAKIX.

David Amsellem -- Piper Sandler -- Analyst

That's helpful. If I may just ask a question about biz dev with the financing agreements in place. Just drilling down. What's your appetite for the addition of the commercial stage or market-ready assets? Where you can leverage the sales infrastructure you have in place? Or even just the late stage assets where presumably you'd be paying significant dollars upfront.

What's your strategic calculus regarding those types of assets?

John Jacobs -- President and Chief Executive Officer

David as I said before our BD strategy is focused on transforming Harmony to a leading rare neuro company with a robust and innovative pipeline of assets. And we have the capabilities internally whether it's clinical regulatory commercial to develop and launch drugs like that with success. And we're looking to go rapidly in our search. We have the capabilities to take any asset from the early stage all the way through to late-stage and on market.

And as we stated earlier we have we're in a strong cash position. We've got a good balance sheet. We're growing revenues. We have access to the public markets and we have our new arrangement with Blackstone, which gives us additional optionality and flexibility.

And we don't need to buy a revenue stream in the short run because of that strength. But certainly we are assessing with an open mind assets anywhere from early stage all the way to on market. As long as they meet our filters and help us achieve that business strategy. So what we're most excited about is our additional optionality and flexibility with Blackstone our strong performance right now that further fuels our ability to execute on our growth strategy.

David Amsellem -- Piper Sandler -- Analyst

OK. All right thanks guys.

John Jacobs -- President and Chief Executive Officer

Thank you, David.


That concludes today's question and answer session. I'd like to turn the call back to John Jacobs for closing remarks.

John Jacobs -- President and Chief Executive Officer

Thank you very much. Look, everyone, I want to thank everyone for joining us sincerely and since we appear to be at the end of the call. I would say for everyone who joined we appreciate your energy we appreciate your questions and we're so excited that you're on this journey with us to discover, develop, acquire, and provide solutions for patients who are living with and facing orphan and rare neurological disorders. Thank you so much, everyone.

We appreciate your time.


[Operator signoff]

Duration: 49 minutes

Call participants:

Lisa Caperelli -- Head of Investor Relations

John Jacobs -- President and Chief Executive Officer

Jeffrey Dierks -- Chief Commercial Officer

Jeffrey Dayno -- Chief Medical Officer

Sandip Kapadia -- Chief Financial Officer

Chris Howerton -- Jefferies -- Analyst

Graig Suvannavejh -- Goldman Sachs -- Analyst

David Amsellem -- Piper Sandler -- Analyst

John Jacobs -- President, Chief Executive Officer, and Director

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