Q3 2025 Harmony Biosciences Holdings Inc Earnings Call

Your conference operator today at this time I would like to welcome everyone to Harmony Biosciences third quarter 2025 financial results Conference call. All participants have been placed on mute to prevent any background noise. After the speakers' 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.

Phone 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 Matthew back. Please go ahead.

Thank you operator, good morning, everyone and thank you for joining US today as we review Harmony Biosciences third quarter 2025 financial results and provide a business update before we start I encourage everyone to go to the investors section of our website to find the materials that accompany our discussion today, including a reconciliation of our GAAP.

To non-GAAP financial measures at this stage of our lifecycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey NAU, President and CEO.

Adam <unk> <unk>, Chief Commercial officer, Dr Kumar, <unk>, Chief Medical and scientific Officer <unk> <unk>.

Speaker #1: Thank you for calling. Please have your conference ID ready.

<unk> <unk>, chief financial and administrative officer.

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. Our actual results may differ materially and we undertake no obligation to update these statements even if circumstances change we encourage you to consult the risk factors referenced in our.

Our SEC filings for additional details I would now like to turn the call over to our CEO, Dr. Jeffrey Dana Jeff.

Thank you Matt.

Good morning, everyone and thank you for joining our call today.

I want to start off by saying, how proud I am of the harmony team and their exceptional performance this quarter.

It reaffirms harmonies reputation for execution excellence.

As we have shared Q3 was a very strong quarter for harmony.

We reported $239 5 million in net revenue for the quarter.

Representing 29% growth year on year.

And with this momentum we recently raised our net revenue guidance for the year from $820 $860 million.

Taking it up to $845 million to $865 million.

We had robust cash generation of $106 million, bringing our balance sheet to $778 million as of September 30th.

But what I am most proud of is that this performance was driven by the highest number of quarterly patient adds for <unk> since our launch.

With an average of 500 patients added this quarter.

Resulting in an average of 8100 patients on <unk> at the end of Q3.

Our chief commercial officer, Adam <unk> will next be providing more color on some of the things. His team is doing to drive this strong momentum in our <unk> business.

There are many different ways to measure impact dill.

Delivering innovative treatments to patient populations living with unmet medical needs is a very meaningful one.

With this sustained momentum.

We believe <unk> is rapidly approaching a $1 billion plus blockbuster status and narcolepsy alone.

Along with our very strong commercial business Harmony also has a robust late stage pipeline with multiple catalysts coming over the next several years.

Continue to have firm conviction in our pipeline.

And full confidence in our R&D team to successfully execute on these programs.

In fact, the IND for <unk>, HD <unk> and high dose formulation has been submitted to FDA and we are on track to initiate two phase III trials, one in narcolepsy and one in idiopathic hypersomnia or IH before the end of the year.

Kumar will provide an update on our pipeline programs later in the call, including an update on the re Kinect study in fragile X syndrome.

Turning to our balance sheet.

With over $778 million in cash and cash equivalents, a disciplined approach to capital deployment.

And a team with extensive industry experience.

Harmony is well positioned to strategically pursue value enhancing assets to add to our pipeline and build a broader product portfolio.

That is our intent and a key component of our vision to become the leading patient focused CNS company delivering innovative treatments that can help even more patients living with unmet medical needs.

We believe that we have built something rare in our industry a.

A profitable self funding biotech company with an innovative catalyst rich pipeline poised to deliver meaningful value for both patients.

And our shareholders.

It is because of this unique profile that we continue to execute from a position of strength.

And coming off of our exceptional Q3 performance. We believe that harmony is one of the most compelling growth stories in biotech today.

A disciplined approach to Capital deployment.

Speaker #2: Thank you for calling. May I have your passcode, please? Hello? Hi. Can I get your passcode? Okay. And can I get the spelling of your first name?

And a team with extensive industry experience.

With that I'll turn the call over to Adam <unk>, Our Chief commercial officer for an update on our outstanding commercial performance Adam.

Thank you Jeff.

<unk> Q3, 2025 results were the strongest we've seen since launch.

<unk> delivered $239 5 million in net sales for the quarter.

Representing nearly 30% year over year growth in its sixth year on the market.

<unk> achieved a record increase in approximately 500 average Krishna for the quarter.

Harmony is well positioned to strategically pursue value-enhancing assets to add to our Pipeline and build a broader product portfolio.

Operator: Good morning. My name is Madison, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences' third quarter 2025 financial results conference call. All participants 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 Matthew Beck. Please go ahead.

This represents the highest quarterly increase we've ever seen them.

After the Q2 increase of approximately 400 average patients which has only been achieved twice previously.

As a result, we fixed achieved approximately 8100 average patients for Q3 exceeding our previous guidance of achieving nearly a thousand patients by a full quarter.

The foundation of <unk> performance has always been the unique position that <unk> owns as the only non scheduled treatment option, resulting in its broad clinical utility.

Matthew Beck: Thank you, Operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' third quarter 2025 financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today, including the 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 speakers on today's call are Dr. Jeffrey Dayno, President and CEO, Adam Zaeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, and Sandip Kapadia, Chief Financial and Administrative Officer. 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 George extremely high brand awareness is perceived as efficacious and well tolerated and is supported by broad payer coverage that has remained consistent for years.

In addition to this I would like to highlight some recent areas of focus.

We have adjusted our field sales deployment.

We'll plan on messaging and continued to deliver sound sales execution.

We've refined our promotion and messaging with <unk>.

<unk> important new payer coverage wins, which continue to expand our already broad payer coverage.

And we have made improvements in how we support patients moving from a <unk> prescription to dispense.

Reflected in higher rates of conversion and shorter times to the expense.

Much of what we're focused on are the fundamentals.

From a sales execution marketing and promotion payer coverage and patient support.

Matthew Beck: Our actual results may differ materially, and we undertake no obligation to update these statements even if circumstances change. We 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, Dr. Jeffrey Dayno. Jeff.

The adjustments, we're making are delivering results and we will continue to look for additional opportunities in all areas moving forward.

As we look to the fourth quarter of 2025, we expect continued growth in average number of patients and momentum.

As a result, we recently raised our full year revenue guidance of $2 $20 million to $860 million to the high end of the range between $8 45, and $865 million and we are rapidly approaching achieving $1 billion plus in annual revenue from narcolepsy alone.

Jeffrey Dayno: Thank you, Matt. Good morning, everyone, and thank you for joining our call today. I want to start off by saying how proud I am of the Harmony team and their exceptional performance this quarter. It reaffirms Harmony's reputation for executional excellence. As we have shared, Q3 was a very strong quarter for Harmony. We reported $239.5 million in net revenue for the quarter, representing 29% growth year-on-year. With this momentum, we recently raised our net revenue guidance for the year from $820 to $860 million, taking it up to $845 to $865 million. We had robust cash generation of $106 million, bringing our balance sheet to $778 million as of 30 September 2023. What I am most proud of is that this performance was driven by the highest number of quarterly patient adds for Wakix since our launch, with an average of 500 patients added this quarter.

Looking to the future the proposed <unk> and HD formulations, each target significant unmet patient needs, while extending our growth potential with utility patents filed through 2044.

Early feedback from physicians and payers on the HD formulation has been particularly encouraging and.

And we will be able to leverage our commercial infrastructure to drive the next phase of growth through our proposals and franchise formulations.

In summary, the performance of our business has never looked better.

Fueled by our highly differentiated product.

Our focus on fundamentals.

Excellent execution across the organization.

We are confident in our continued growth and performance moving forward and now I'd like to turn the call over to our Chief Medical and scientific Officer Kumar of a door to discuss the advancements in our clinical development programs Kumar.

Thank you Adam good morning, everyone and thank you for joining us today.

Jeffrey Dayno: Resulting in an average of 8,100 patients on Wakix at the end of Q3. Our Chief Commercial Officer, Adam Zaeske, will next be providing more color on some of the things his team is doing to drive this strong momentum in our Wakix business. There are many different ways to measure impact. Delivering innovative treatments to patient populations living with unmet medical needs is a very meaningful one. With this sustained momentum, we believe Wakix is rapidly approaching a $1 billion-plus blockbuster status in narcolepsy alone. Along with our very strong commercial business, Harmony also has a robust late-stage pipeline with multiple catalysts coming over the next several years. I continue to have firm conviction in our pipeline and full confidence in our R&D team to successfully execute on these programs.

We continue to make good progress in R&D.

Three phase III registration studies ongoing and anticipate up to five phase III registration studies in five distinct indication by the end of the year.

That is our intent and a key component of our vision to become the leading patient focused, CNS company, delivering Innovative treatments that can help. Even more patients living with unmet medical needs.

We have some important updates to share on the nextgen programs.

Speaker #2: And the name of your company? Thank you very much. I'll place you on your conference. Thank you.

Starting with those pizza franchise with <unk>.

Continued to make significant progress across our <unk> program.

I am pleased to report that we have.

Fabric R&D for Qdoba.

Because the SBA.

We believe that we have built something rare in our industry. A profitable self-funding, biotech company with an Innovative Catalyst, Rich pipeline poised to deliver meaningful value for both patients.

But because it's deeper.

Program and enhanced formulation with an optimized strategic profile and higher dose.

Targeting enhanced efficacy for excessive daytime sleepiness.

Excluding a differentiated label with an indication for <unk> do narcolepsy is on track for phase III initiation in Q4 2025.

Similarly, the phase III study with <unk>.

Jeffrey Dayno: In fact, the IND for pitolisant HD, our pitolisant high-dose formulation, has been submitted to FDA, and we are on track to initiate two phase 3 trials, one in narcolepsy and one in idiopathic hypersomnia, or IH, before the end of the year. Kumar will provide an update on our pipeline programs later in the call, including an update on the RECONNECT study in fragile X syndrome. Turning to our balance sheet, with over $778 million in cash and cash equivalents, a disciplined approach to capital deployment, and a team with extensive industry experience, Harmony is well-positioned to strategically pursue value-enhancing assets to add to our pipeline and build a broader product portfolio. That is our intent, and a key component of our vision to become the leading patient-focused CNS company delivering innovative treatments that can help even more patients living with unmet medical needs.

In patients with idiopathic hypersomnia.

His own for pursuing a differentiated label with an indication for sleep in this year and we are on track for the East Houston in Q4 2025.

Pocket Bluford dates for both programs are in 2028.

The other mixed with olefin formulation predominance in Geos is designed to minimize the potential for treatment related Gi side effects.

Basically since almost 90% of patients with narcolepsy experienced co morbid symptoms.

In addition, we've done us in CR also pulling some ability with pockets of penetrating dose range at 17, eight milligram, eliminating the need for titration.

Important differentiation.

To demonstrate this we conducted a dosing optimization study, which is now completed.

We are excited to share that in this study patients with narcolepsy startup Mcdonald and Geos at 17, eight milligram and 100% of the patients that is all 46, 46%.

Jeffrey Dayno: We believe that we have built something rare in our industry: a profitable, self-funding biotech company with an innovative, catalyst-rich pipeline poised to deliver meaningful value for both patients and our shareholders. It is because of this unique profile that we continue to execute from a position of strength. Coming off of our exceptional Q3 performance, we believe that Harmony is one of the most compelling growth stories in biotech today. With that, I'll turn the call over to Adam Zaeske, our Chief Commercial Officer, for an update on our outstanding commercial performance. Adam.

Any cyclicality geos at the therapeutic dose of $17 eight will it come with more safety or tolerability issues.

98% of the patients who received <unk> kiosk $35 six milligram at week, two tolerated the higher dose.

No new <unk>.

Ftes were observed from this study.

<unk> is a fast to market strategy designed to demonstrate bio equivalents to make X formulation.

The top line data from the pivotal be study is on track for Q4 2025 with a target to do for US in Q1 2027.

Utility patents have been filed for both between the <unk> and <unk> HD with potential exclusivity through 2044, securing long term franchise value.

Adam Zaeske: Thank you, Jeff. Harmony's Q3 2025 results were the strongest we've seen since launch. Wakix delivered $239.5 million in net sales for the quarter, representing nearly 30% year-over-year growth in its sixth year on the market. Wakix achieved a record increase in approximately 500 average patients for the quarter. This represents the highest quarterly increase we've ever seen and comes after the Q2 increase of approximately 400 average patients, which has only been achieved twice previously. As a result, Wakix achieved approximately 8,100 average patients for Q3, exceeding our previous guidance of achieving nearly 8,000 patients by a full quarter. The foundation of Wakix's performance has always been the unique position Wakix owns as the only non-scheduled treatment option, resulting in its broad clinical utility. Wakix enjoys extremely high brand awareness, is perceived as efficacious and well-tolerated, and is supported by broad payer coverage that has remained consistent for years.

Beyond <unk>, our portfolio continues to advance with BP, One dock 50 to fight a highly potent orexin two receptor agonist.

<unk> best in class potential in preclinical studies.

At the recent sleep meeting in Seattle and World Congress meeting in Singapore.

Great comprehensive preclinical safety and efficacy data.

One striking efficacy at <unk>.

Low doses across on pattern because of interest in the standard setting.

<unk> model.

We are on track to dose the first subject later this quarter and we anticipate sharing clinical data in 2026.

In the <unk> franchise.

We have already disclosed the Zealand 002 phase III reconnect study in <unk> syndrome, and did not meet the primary endpoint of improvement in Scotia, Hawaiian mainly due to higher than expected placebo response.

Adam Zaeske: In addition to this, I'd like to highlight some recent areas of focus. We have adjusted our field sales deployment, call plan, and messaging, and continue to deliver sound sales execution. We've refined our promotion and messaging. We've secured important new payer coverage wins, which continue to expand our already broad payer coverage. We have made improvements in how we support patients moving from a Wakix prescription to dispense, reflected in higher rates of conversion and shorter times to dispense. Much of what we are focused on are the fundamentals, from sales execution, marketing and promotion, payer coverage, and patient support. The adjustments we are making are delivering results, and we will continue to look for additional opportunities in all areas moving forward. As we look to the fourth quarter of 2025, we expect continued growth in average number of patients and momentum.

This is disappointing for harmony.

40, <unk> <unk> syndrome community, who continue to wait.

<unk> therapies.

The in depth review of full data set is ongoing and we plan to share additional information in the near future.

The 0002 program in 'twenty, two deletion syndrome has been paused pending the full review of the economic data.

Yes.

Epilepsy franchise, we continue to actively enroll patients in two global phase III Registrational trials with <unk> 100.

The AGA study in <unk> syndrome, and delight Hal study in Lennox <unk> syndrome.

<unk> hundred <unk> hydrochloride is up quite rates due to federal domestic agonist and work via enhancing set of domestic tone and established mechanism of action for developmental and epileptic encephalopathy.

In addition, it has a unique safety and Tolerability profile and the emerging safety profile is supportive of no requirements for additional laboratory special safety monitoring compared to some of the drugs commonly used in these disorders.

Adam Zaeske: As a result, we recently raised our full-year revenue guidance of $820 to $860 million to the high end of the range between $845 and $865 million, and we are rapidly approaching achieving $1 billion-plus in annual revenue from narcolepsy alone. Looking to the future, the pitolisant GR and HD formulations each target significant unmet patient needs while extending our growth potential with utility patents filed through 2044. Early feedback from physicians and payers on the HD formulation has been particularly encouraging, and we will be able to leverage our commercial infrastructure to drive the next phase of growth through our pitolisant franchise formulations. In summary, the performance of our business has never looked better, fueled by a highly differentiated product, a focus on fundamentals, and excellent execution across the organization. We are confident in our continued growth and performance moving forward.

We will be presenting some of the efficacy data from the August open label extension study and the safety Tolerability data on Edp X 100.

American Epilepsy Society meeting in December.

Finally on behalf of harmony.

I would like to thank all the patients and their families who are participating in our clinical trials as one of the clinical investigators and site personnel for their efforts and commitment in helping us advance our development programs.

I will now turn the call over to CFO Sandeep <unk>.

For an update on our financial performance.

Thank you Kumar and good morning, everyone. This morning, we issued our third quarter 2025 earnings release and filed our 10-Q, where you'll find the detail of our financial and operating results winter.

Adam Zaeske: I'd like to turn the call over to our Chief Medical and Scientific Officer, Kumar Budur, to discuss the advancements in our clinical development programs. Kumar.

We delivered strong financial results in the third quarter with our highest quarter to date in revenues and cash generation, our financial performance and profile positions us well to continue advancing our growth strategy for the remainder of 2025 and beyond.

Kumar Budur: Thank you, Adam. Good morning, everyone, and thank you for joining us today. We continue to make good progress in R&D with three phase 3 registration studies ongoing and anticipate up to five phase 3 registration studies in five distinct indications by the end of the year. We have some important updates to share on the next-gen pitolisant programs. Starting with our sleep franchise, we continue to make significant progress across our next-gen pitolisant programs. I'm pleased to report that we have submitted the IND for pitolisant HD to the FDA. The pitolisant HD program, an enhanced formulation with an optimized PK profile and higher dose, targeting enhanced efficacy for excessive daytime sleepiness and pursuing a differentiated label with an indication for fatigue in narcolepsy, is on track for phase 3 initiation in Q4 2025.

We reported net revenues of $239 5 million compared to $186 million in the prior year quarter, representing a growth of 29% year over year.

The growth was driven by very strong demand for wages as demonstrated by a record increase in average number of patients along with an increase in trade inventories of a few days as we head into the fourth quarter.

We reported total operating expenses for the third quarter of $114 3 million compared to $81 6 million for the same quarter in 2024.

Expenses during the third quarter of 2025 included investments to advance our late stage pipeline is $15 million milestone for the completion of the enrollment of the <unk> trial as well as continued commercialization of <unk> in narcolepsy.

We also continued to show solid net income growth.

Kumar Budur: Similarly, the phase 3 study with pitolisant HD in patients with idiopathic hypersomnia is also pursuing a differentiated label with an indication for sleep inertia, and we are on track for initiation in Q4 2025. The target dates for both programs are in 2028. The other next-gen pitolisant formulation, pitolisant GR, is designed to minimize the potential for treatment-related GI side effects, especially since almost 90% of patients with narcolepsy experience comorbid GI symptoms. In addition, pitolisant GR also provides an ability to start at the therapeutic dose range at 17.8mg, eliminating the need for titration. An important differentiation. To demonstrate this, we conducted a dosing optimization study, which is now completed.

non-GAAP adjusted net income for the third quarter of 2025 was $63 5 million or $1 <unk> per diluted share compared to $57 3 million or 99 per diluted share in the prior year quarter.

We believe non-GAAP adjusted net income better reflect the underlying business performance.

Please see our press release for a reconciliation of GAAP to non-GAAP results.

As previously mentioned Army ended the third quarter with approximately $778 million in cash cash equivalents and investments.

The balance reflects strong cash generation, resulting in an increase of $106 million in the third quarter.

We continue to actively pursue value enhancing strategic opportunities to deploy our capital to expand our portfolio and drive value for shareholders.

Looking ahead in 2025, our strong performance through Q3 gives us increasing confidence in our full year outlook.

Kumar Budur: We are excited to share that in this study, patients with narcolepsy started Pitolisant GR at 17.8mg, and 100% of the patients, that is all 46 of 46 patients, were able to initiate Pitolisant GR at the therapeutic dose of 17.8mg with no safety or tolerability issues. In addition, 98% of the patients who received Pitolisant GR 35.6mg at week two tolerated the higher dose well. No new AEs or SAEs were observed from this study. Pitolisant GR is a fast-to-market strategy designed to demonstrate bioequivalence to Wakix formulation. The top-line data from the pivotal BE study is on track for Q4 2025, with a target to do for in Q1 2027. Utility patents have been filed for both Pitolisant GR and Pitolisant HD, with potential exclusivity to 2044, securing long-term franchise value.

Recently raised our revenue guidance from $820 million to $860 million to 845% to $865 million.

These results also gives us confidence that we are rapidly approaching blockbuster status, we're awake and narcolepsy alone.

With respect to expenses, we expect continued investment in R&D as we advance our late stage pipeline with the startup of two phase III studies for our <unk> HD programs.

As a result, we expect to have five ongoing phase III registrational programs by the end of the year.

In addition, we also expect a milestone of $4 million in Q4 related to the initiation of our phase one trial and our Orexin two agonist program.

In summary, we had very strong result for this quarter, along with positive momentum going into Q4.

And our shareholders.

That along with our strength of our balance sheet puts us in a solid position to accelerate our growth strategy and drive value for shareholders.

Kumar Budur: Beyond pitolisant, our sleep portfolio continues to advance with BP1.15205, a highly potent orexin receptor agonist demonstrating best-in-class potential in preclinical studies. At the recent sleep meeting in Seattle and World Sleep Congress meeting in Singapore, we presented comprehensive preclinical safety and efficacy data that demonstrated efficacy at very low doses across all parameters of interest in a standard translational mouse model. We are on track to dose the first subject later this quarter, and we anticipate sharing clinical data in 2026. In the neurobehavioral franchise, as we have already disclosed, the ZYN002 phase 3 RECONNECT study in Fragile X syndrome did not meet the primary endpoint of improvement in social avoidance, mainly due to higher-than-expected placebo response. This is disappointing for Harmony and for the Fragile X syndrome community, who continue to wait for approved therapies.

And with that I'll turn the call back over to Jeff for his closing remarks.

Thank you Sandy.

And my thanks to everyone for joining our call today and for your interest in Harmony Biosciences.

In closing I.

I am very proud of our team's exceptional performance in the third quarter and energized by our progress.

Let me highlight a few key points to leave you with.

First we delivered a very strong quarter with 29% year on year revenue growth driven by a record number of an average of 500, new patient adds for the quarter.

With this sustain momentum.

We believe <unk> is rapidly approaching a one by $1 billion plus blockbuster status and narcolepsy alone.

Looking ahead our.

Our late stage pipeline remains robust and I continue to have strong conviction in our pipeline programs, which are making excellent progress.

Kumar Budur: The in-depth review of the full data set is ongoing, and we plan to share additional information in the near future. The ZYN002 program in 22q deletion syndrome has been paused pending the full review of the RECONNECT data. In our epilepsy franchise, we continue to actively enroll patients in two global phase 3 registration trials with EPX100: the Argus study in Dravet syndrome and the Lighthouse study in Lennox-Gastaut syndrome. EPX100, or clemizole hydrochloride, is a 5-HT2 serotonergic agonist and works via enhancing serotonergic tone, an established mechanism of action for developmental and epileptic encephalopathies. In addition, it has a unique safety and tolerability profile, and the emerging safety profile is supportive of no requirements for additional laboratory or special safety monitoring compared to some of the drugs commonly used in these disorders.

Lastly, we continue to strengthen our unique profile of being a profitable self funding biotech company with an innovative catalyst rich pipeline poised to deliver meaningful value for patients providers and shareholders alike.

We believe that this is what makes harmony one of the most compelling growth stories in biotech today.

Thank you and I will now turn the call back over to the operator for Q&A operator.

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 star Q, We remind you to please pickup your handset and please limit yourself to one question and one follow up question and we will take our first question from Amy <unk> with me.

Please go ahead.

On the <unk>.

<unk> quarter.

Kumar Budur: We will be presenting some of the efficacy data from the Argus open-label extension study, and the safety, tolerability data on EPX100 at the upcoming American Epilepsy Society meeting in December. Finally, on behalf of Harmony, I would like to thank all the patients and their families who are participating in our clinical trials, as well as the clinical investigators and site personnel, for their efforts and commitment in helping us to advance our development programs. I'll now turn the call over to our CFO, Sandip Kapadia, for an update on our financial performance. Sandip.

My first question is just around the <unk> guidance.

You've obviously raised your guidance and even if we look at the year to date performance compared to the full year 2024.

It is because of this unique profile that we continue to execute from a position of strength.

Acceleration in the new patient adds this year.

Sure.

So if you could sort of elaborate on.

How you see the trajectory of <unk> evolving.

It's 77 years into the launch but it appears that there is exploration here. So if you could comment on how you see that evolving into 2026, and if that can be sustained.

And coming off of our exceptional Q3 performance. We believe that Harmony is 1 of the most compelling growth stories in biotech today.

And then I have one or two other questions. Thank you.

Sandip Kapadia: Thank you, Kumar, and good morning, everyone. This morning, we issued our third quarter 2025 earnings release and filed our 10Q, where you'll find the details of our financial and operating results. We delivered strong financial results in the third quarter, with our highest quarter-to-date in revenues and cash generation. Our financial performance and profile positions us well to continue advancing our growth strategy for the remainder of 2025 and beyond. We reported net revenues of $239.5 million compared to $186 million in the prior year quarter, representing a growth of 29% year-over-year. The growth was driven by very strong demand for Wakix, as demonstrated by our record increase in average number of patients, along with an increase in trade inventories of a few days as we head into the fourth quarter.

Okay. Good morning, Amie. Thank you for your question.

Good morning. My name is Madison and I will be your conference operator. Today at this time I would like to welcome everyone. To Harmony biosciences, third quarter, 2025 Financial results. Conference call all participants have been placed on mute to prevent any background noise. After the speakers remarks, there will be a question and answer session if you would like to ask a question at that time, please press star 1 on your telephone,

I am going to turn it over.

Speaker #1: Thank you for your continued patience. Your meeting will begin shortly. If you need assistance at any time, please press star zero, and a member of our team will be happy to help you.

To add on to speak about it in terms of the trajectory of patient adds in.

Strong fundamentals there and then Sandeep can comment on kind of our thoughts on traditional and guidance from Adam Yeah. Thanks, Jeff and good morning Amie. Thanks.

Thanks for the question. So yes performance is going to be driven fundamentally by patient adds and as you saw we were extremely pleased with the quarterly increase in average patients are 500, we haven't seen that high of an increase ever.

So for us when it comes on the back of.

Our solid Q2 increase of 400 patients, which we had only seen twice previously in the last time, we saw an increase of 400 patients groups I think early in 2022. So we're very pleased with the with the underlying performance of the brand and the fundamentals remained strong and our momentum.

We expect to carry forward into Q4, but the second quarter.

Sandip Kapadia: We reported total operating expenses for the third quarter of $114.3 million compared to $81.6 million for the same quarter in 2024. The expenses during the third quarter of 2025 included investments to advance our late-stage pipeline, a $15 million milestone for the completion of the enrollment of the ZYN002 trial, as well as continued commercialization of Wakix in narcolepsy. We also continue to show solid net income growth. Non-GAAP-adjusted net income for the third quarter of 2025 was $63.5 million, or $1.08 per diluted share, compared to $57.3 million, or $0.99 per diluted share, in the prior year quarter. We believe non-GAAP-adjusted net income better reflects the underlying business performance. Please see our press release for a reconciliation of GAAP to non-GAAP results. As previously mentioned, Harmony ended the third quarter with approximately $778 million in cash, cash equivalents, and investments.

Sure.

Yes, no absolutely.

As mentioned on the call I mean, we recently raised our guidance from $820 million to $160 million to 845 or 60.

$5 million.

As reflected in the guidance, we saw really good strong demand as Adam just talked about we did also see slight.

Slight increase in trade inventory during the quarter, which obviously had an impact as you may recall in Q Q2 was the opposite we saw a bit of a drawdown again its typical wholesaler ordering patterns thing is it's hard to predict these things as we go into Q4, but we feel very good about the topline demand growth because ultimately that's what helps drive.

with that, I'll turn the call over to Adam zaeske, our chief commercial officer for an update on our outstanding commercial performance, Adam,

Thank you, Jeff.

Revenues at the end of the day and so what we're seeing we're very optimistic about top line growth in terms of patient as we go into the next quarter.

And with regard to revenues, it's really just a question of where we ended up with trade inventories from time at year end is hard to predict so again, it's going to be a very strong year.

Well ahead of our original guidance.

Head of our guidance in terms of net patient adds for the year. We had originally guided to about 8000 patients and were well ahead of that as well by year end. So really we're going to see great momentum going into the end of the year on top line demand and certainly going into 2000 22026 and of course we.

Sandip Kapadia: The balance reflects strong cash generation, resulting in an increase of $106 million in the third quarter. We continue to actively pursue value-enhancing strategic opportunities to deploy our capital to expand our portfolio and drive value for shareholders. Looking ahead in 2025, our strong performance through Q3 gives us increasing confidence in our full-year outlook. We recently raised our revenue guidance from $820 to $860 million to $845 to $865 million. These results also give us confidence that we are rapidly approaching blockbuster status for Wakix in narcolepsy alone. With respect to expenses, we expect continued investment in R&D as we advance our late-stage pipeline with the start of two phase 3 studies for our pitolisant HD programs. As a result, we expect to have five ongoing phase 3 registrational programs by the end of the year.

We're rapidly approaching blockbuster status for wafers, yes, yes, I mean, I would just add that I think obviously, we're very pleased with the recent trends.

And we're following them in terms of.

How that will sustain us going into the future but.

Underlying fundamentals remain very strong pleased with obviously some of the things Adam has been with the commercial team.

And that positions us well going forward.

Great. Thank you and my next question was just for Kumar.

With regards to the GR formulation.

Can you give us some color on what led the Gi aes.

The Geos combination how did the greater frequency of those as compared to the end market.

Set of titration and the initial dosing period.

Yeah, Hey, good morning, Jeremy Thanks for the question.

Sandip Kapadia: In addition, we also expect a milestone of $4 million in Q4 related to the initiation of our phase one trial in our RX12 agonist program. In summary, we had very strong results for this quarter, along with positive momentum going into Q4. That, along with the strength of our balance sheet, puts us in a solid position to accelerate our growth strategy and drive value for shareholders. With that, I'll turn the call back over to Jeff for his closing remarks. Jeff.

What we are disclosing right now with no new safety or Tolerability issues.

Harmonies Q3 2025 results with the strongest we've seen since launch.

Sure.

<unk>, Dr formulation, North East, Florida absurd.

The safety and Tolerability was in general consistent with the established safety and Tolerability profile of predominant in Geos.

We will be disclosing the full data set.

In upcoming meetings haven't decided when exactly but what's important from the <unk> formulation of <unk>.

Jeffrey Dayno: Thank you, Sandip. My thanks to everyone for joining our call today and for your interest in Harmony Biosciences. In closing, I am very proud of our team's exceptional performance in the third quarter and energized by our progress. Let me highlight a few key points to leave you with. First, we delivered a very strong quarter with 29% year-on-year revenue growth, driven by a record number of an average of 500 new patient adds for the quarter. With this sustained momentum, we believe Wakix is rapidly approaching a $1 billion-plus blockbuster status in narcolepsy alone. Looking ahead, our late-stage pipeline remains robust, and I continue to have strong conviction in our pipeline programs, which are making excellent progress.

We initiated 46 patients with narcolepsy with $3 <unk> 78, a $17 eight milligram.

And all of the patient.

We're successfully able to accommodate 17 eight gram.

About 98% of the patient pool range 230.

<unk> 5.6 milligram after one week of retailer.

Geos.

8% of them were able to tolerate <unk> TR 35.6, and this is an important differentiation because if you look at.

The medicines that are approved for patients with narcolepsy.

One of them including per dollar spent.

Some level of penetration.

Getting rid of the titration will have the patience to start at the therapeutic dose range.

Shelly can experience efficacy earlier potentially less number of dropbox and potentially better overall patient experience.

Jeffrey Dayno: Lastly, we continue to strengthen our unique profile of being a profitable, self-funding biotech company with an innovative, catalyst-rich pipeline poised to deliver meaningful value for patients, providers, and shareholders alike. We believe that this is what makes Harmony one of the most compelling growth stories in biotech today. Thank you, I will now turn the call back over to the operator for Q&A. Operator.

Got it.

Thank you.

And one more other quick question if you could just elaborate on.

Some of the details of what we should expect from the Rguest.

David extension data at Aes in December.

Thanks.

Yes, Thank you Amit.

We will be presenting some efficacy data on <unk> 100 from the August open label extension study.

We will also be presenting safety and Tolerability data from <unk> hundred from the same study AGA double blind randomized study and also the open label extension study.

Operator: Thank you. At this time, if you would like to ask a question, please press Star 1 on your telephone keypad. If you wish to remove yourself from the queue, you may do so by pressing Star 2. We remind you to please pick up your handset, and please limit yourself to one question and one follow-up question. We will take our first question from Ami Fadia with Needham. Please go ahead.

You see the wall at all.

Secondly.

The safety Tolerability offered or will it all very unique benefit risk profile for patients with developmental and epileptic encephalopathy. In this particular instance, particularly the data that we'll be shedding is in patients with <unk> syndrome.

Ami Fadia: Thanks on the strong third quarter. My first question is just around kind of your guidance. You've obviously raised your guidance, and even if we look at the year-to-date performance compared to the full year 2024, there's certainly acceleration in the new patient adds this year. If you could sort of elaborate on how you see the trajectory of Wakix evolving. It's certainly several years into the launch, but it appears that there is acceleration here. If you could comment on how you see that evolving into 2026 and if that can be sustained. I have one or two other questions. Thank you.

Okay.

Thank you. Thank you Amit thank you. Thanks.

Thank you and we will take our next question from David <unk> with Piper Sandler. Please go ahead.

Thanks, just a couple for me.

First I wanted to get your latest thoughts on Biz Dev and M&A, particularly in light of the failures Hi, Joe are you thinking.

More expansively regarding.

Acquisitions are you open to more of a.

A sizable transaction, perhaps a market ready or commercial stage asset just trying to get a sense philosophically for where your heads are at that's number one and then number two looking a bit longer term regarding wake effects with the introduction of the first orexin agonist coming potentially before the end of <unk>.

Jeffrey Dayno: Okay. Good morning, Amy. Thank you for your question. I'm going to turn over to Adam to speak about, in terms of the trajectory of patient adds and the strong fundamentals there. Sandeep can comment on kind of our thoughts and positional guidance. Adam.

Adam Zaeske: Yeah. Thanks, Jeff. Good morning, Amy. Thanks for the question. Performance is going to be driven fundamentally by patient adds. As you saw, we were extremely pleased with the quarterly increase in average patients of 500. We haven't seen that high of an increase ever since launch. It comes on the back of a solid Q2 increase of 400 patients, which we had only seen twice previously. The last time we saw an increase of 400 patients was, I think, early in 2022. We're very pleased with the underlying performance of the brand, and the fundamentals remain strong. That momentum we expect to carry forward into Q4. Sandeep, do you want to mention.

26, and I know, it's just been too one.

How are you thinking about the trajectory of <unk> beyond 'twenty six specifically in.

In 2007 with overcorrection.

Potentially in the market.

Good morning, David Thanks here on your questions. So first with regards to Biz Dev and <unk>.

Sort of thinking there.

Really hasnt changed we have always been.

Focus on business development being strategic thoughtful and how we deploy our capital.

As we have build out our pipeline.

Obviously, the <unk> acquisition and then epigenetics.

Sandip Kapadia: Sure.

Adam Zaeske: Your thoughts on that?

Sandip Kapadia: Yeah. No, absolutely. As mentioned on the call, I mean, we recently raised our guidance from $820 to $860 million to $845 to $865 million. As reflected in the guidance, we saw really good, strong demand, as Adam just talked about. We did also see a slight increase in trade inventory during the quarter, which obviously had an impact. As you may recall, in Q2, it was the opposite. We saw a bit of a drawdown. Again, it's typical wholesaler ordering patterns. The thing is, it's hard to predict these things as we go into Q4, but we feel very good about the top-line demand growth because ultimately, that's what helps drive revenues at the end of the day. What we're seeing, we're very optimistic about top-line growth in terms of patient adds as we go into the next quarter.

I think at this point.

Despite the fragile X data readout it doesn't really change our strategy, we have a dedicated BD team focused on sort of search and evaluation.

And at this point.

It really is our intent with our strong balance sheet.

To pursue innovative assets to build out our pipeline to grow our product portfolio.

We are actively evaluating several.

And that is our plan the strategy remains the same our focus in orphan rare CNS disorders.

To be strategic within the current franchises.

Sandip Kapadia: With regard to revenues, it's really just a question of where we end up with trade inventory sometimes. At year-end, it's hard to predict. Again, it's going to be a very strong year, well ahead of our original guidance, again, ahead of our guidance in terms of net patient adds for the year. We had originally guided to about 8,000 patients, and we're well ahead of that as well by year-end. Really, we're going to see great momentum going into the end of the year on top-line demand, and certainly going into 2026. Of course, we're rapidly approaching blockbuster status for Wakix.

But also looking at adjacencies potentially and broader neuro indications.

Where we could.

Utilize the proven commercial engine.

So the strategy remains the same.

I think a bit more focused with regards to our intent.

To move forward with business development, when we find the right opportunities for us.

Yes.

And <unk>.

Turn to Adam in terms of thoughts on <unk> performance in the setting of emergent Orexin, It's Adam Yeah. Thanks, Geoff and thanks for the question David.

Jeffrey Dayno: Yeah. Yeah. I mean, I would just add that I think obviously, we're very pleased with the recent trends, and we're following them in terms of how that will sustain us going into the future. Underlying fundamentals remain very strong. Pleased with, obviously, some of the things Adam has done with the commercial team, and that position as well going forward.

Look we're excited about.

<unk>, obviously because.

We have one of our own but it's all.

Also an important.

Potential new treatment option for patients and we remain confident in our ability to grow and perform with <unk> well into the future and there is a couple of reasons for that.

The first is just the approach to therapy in this market the hallmark of treatment is polypharmacy.

Ami Fadia: Great. Thank you. My next question was just for Kumar. With regards to the GR formulation, can you give us some color on what were the GI AEs seen with the GR formulation, and how did the grade or frequency of those AEs compare to the in-market Wakix sort of titration in the initial dosing period?

The high majority of patients that are on two or more therapies.

That will continue.

Recently verify that and some market research that we've done speaking with physicians and I expect that to continue as well.

But also if you just look at the history of <unk> performance has been extremely steady regardless of new entrants, whether it's brands or generics.

And we would expect that to continue as well in fact, if you look at kind of the narcolepsy market in total anytime there has been a new brand entrants tend to expand brand utilization.

Adam Zaeske: Yeah. Hey, good morning, Amy. Thanks for the question. What we are disclosing right now is no new safety or tolerability issues observed with the Pitolisant GR formulation. No serious AEs were observed. The safety and tolerability was, in general, consistent with the established safety tolerability profile of Pitolisant GR. We will be disclosing the full dataset in upcoming meetings. Haven't decided when exactly. What's important from the Pitolisant GR formulation, Amy, is we initiated 46 patients with narcolepsy with Pitolisant GR at 17.8mg. All of those patients were successfully able to tolerate 17.8mg. About 98% of the patients who went to get 35.6mg after one week of Pitolisant GR, 98% of them were able to tolerate Pitolisant GR 35.6mg.

And we would expect a similar phenomenon with with <unk>.

Those come to market.

But we're also highly confident just because <unk> is a highly differentiated product really nonscheduled treatment option physicians who've had seven plus years of clinical experience by the time of erection launching it.

<unk> unique position in the minds of health care providers.

Our highly familiar with it.

Provides.

Strong efficacy.

And I believe it's very well tolerated so it can be added to.

The combinations of therapies across a very broad selection of narcolepsy patients and that will continue as well.

<unk> so for those reasons I think we're very confident in our continued growth and performance well into the future.

Okay. Thank you.

Thanks, David.

Thank you Andrew we will take our next question from Greg <unk> with Mizuho. Please go ahead. Your line is open.

Adam Zaeske: This is an important differentiation because if you look at the medicines that are approved for patients with narcolepsy, every one of them, including pitolisant, has some level of titration. Getting rid of the titration will help the patients to start at the therapeutic dose range, potentially can experience efficacy earlier, potentially less number of dropouts, and potentially better overall patient experience.

Hey, good morning, Thanks for taking my question and congrats on the progress.

One question from me just going back to the 2025 guidance.

It was nice to see a raising of the guidance, but if you do the math it does imply fourth quarter sales for Waco wake kicks in the range of I think $2 21 to 241.

On a quarter over quarter basis, essentially flat or down on a quarter over quarter basis. So can you just provide more color on how we should be thinking about whether it's net patient adds or gross to net or seasonality when trying to model fourth quarter I know you.

Ami Fadia: Got it. Thank you. If I could just squeeze in one more quick question, if you could elaborate on some of the details of what we should expect from the Argus open-label extension data at AES in December. Thanks.

You had mentioned some inventory.

Could be a factor, but any other color would be great on the fourth quarter, especially given the great momentum on net patient adds.

Yes, hi.

Adam Zaeske: Yeah. Thank you, Ami. Yes, we will be presenting some efficacy data on EPX100 from the Argus open-label extension study. We'll also be presenting safety and tolerability data from EPX100 from the same study, Argus double-blind randomized study, and also the open-label extension study. You'll see the overall efficacy, the safety, tolerability, offers an overall very unique benefit-risk profile for patients with developmental and epileptic encephalopathies. In this particular instance, particularly the data that we'll be sharing is in patients with Dravet syndrome. Thank you.

Thanks, Craig for the question again, I think we saw great demand in terms of top line growth that we expect to continue as we go from Q3 to Q4 as well I think we did.

Mentioned, we did see a few days of trade inventory increase in Q3, which impacted the sales positively just as as I mentioned in Q2 is quite the other way the other direction right now I mean, we feel very good about the range that we put out there. We recently raised that as you mentioned this gives us great confidence.

And I'm sure every.

I mean, we will do everything we can to certainly not only meet but potentially.

The range as well.

Again, it's hard to predict again before.

There are typical variability as it comes in Q4, especially around brand and holidays and so forth. So yes, we feel good about where it is it's very robust growth year over year, it's going to be a robust growth over prior year.

Jeffrey Dayno: Thank you, Ami.

Ami Fadia: Thank you. Thanks.

Operator: Thank you. We will take our next question from David Amsellem with Piper Sandler. Please go ahead.

And we see again weight takes very quickly approaching blockbuster status.

David Amsellem: Thanks. Just a couple for me. First, wanted to get your latest thoughts on BizDev and M&A, particularly in light of the failure of Zygel. Are you thinking more expansively regarding acquisitions? Are you open to more of a sizable transaction, perhaps a market-ready or commercial-stage asset? Just trying to get a sense philosophically for where your heads are at. That's number one. Number two, looking a bit longer term regarding Wakix with the introduction of the first orexin agonist coming potentially before the end of 2026, and I know it's just NT1. How are you thinking about the trajectory of Wakix beyond 2026, specifically in 2027 with ovopiroxine potentially in the market? Thanks.

As we go into 'twenty and beyond.

Great if I could ask a follow up just your net cash position is building quite nicely I'm sure.

Sure.

There are various use and how to deploy that cash.

Wondering if maybe.

And an answer that might be slightly different from David's question on BD, what are your kind of current thoughts.

On how best to deploy that.

Nicely accruing cash balance.

Sure I mean look we.

As Jeff mentioned I mean, we continue to look for business development opportunities I think.

And our strategy for many years now and we see attractive opportunities out there.

We could potentially transact and we are again continued growth in terms of cash.

Had very strong cash generation last quarter of 100.

Jeffrey Dayno: Yeah. Good morning, David. Thanks for your questions. First, with regards to BizDev and our sort of thinking there, I mean, it really hasn't changed. We have always been focused on business development, being strategic, thoughtful in how we deploy our capital. As we have built out our pipeline, obviously, there's an herb acquisition and then epigenetics. I think at this point, despite the fragile X data readout, it doesn't really change our strategy. We have a dedicated BD team focused on sort of search and evaluation. At this point, it really is our intent with our strong balance sheet to pursue innovative assets, to build out our pipeline, to grow our product portfolio. We are actively evaluating several, and that is our plan. The strategy remains the same, our focus in orphan rare CNS disorders.

$6 million $778 million at the end of the quarter.

And I think that gives us increasing confidence that we have but again, we're going to be I would say.

Way kicks delivered 239 and a half million in net sales for the quarter.

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 Matthew back. Please go ahead.

Representing nearly 30% year-over-year growth and its sixth year on the market.

Thoughtful in terms of how we deploy our capital I think we certainly have multiple ways in which to drive value for shareholders. Certainly more recently, we've been prioritizing business development, but in the past. We've also done share buyback as well as an opportunity and again at the right time, we will look at various opportunities to drive value for shareholders.

Wix achieved a record increase in approximately 500 average patients for the quarter.

This represents the highest quarterly increase we've ever seen and comes after the Q2 increase of approximately 400 average patients, which has only been achieved twice previously.

Thank you, operator. Good morning, everyone. And thank you for joining us today as we review, Harmony biosciences, third, quarter, 2025 Financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today, including the 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 speakers on today's call are Dr. Jeffrey do president and CEO.

As a result wakes achieved approximately 8,100 average patients for Q3 exceeding. Our previous guidance of achieving nearly 8,000 patients by a full quarter.

Thank you.

Greg I'll just go ahead.

No no I appreciate the question I, just want to reiterate I think.

One can never predict the timing in terms of business development transactions as Sandeep alluded to.

<unk>.

We have optionality.

But our focus and our intent.

It's really to pursue innovative value enhancing assets, we want to build our pipeline, we see that's where the value is going forward as well as build a broader product portfolio.

Jeffrey Dayno: To be strategic within the current franchises, but also looking at adjacencies, potentially in broader neuro indications where we could utilize the proven commercial engine. The strategy remains the same. I think a bit more focused with regards to our intent to move forward with business development when we find the right opportunities for us. I'll turn to Adam in terms of thoughts on Wakix performance in the setting of emergent erections. Adam.

In terms of we have a strong commercial engine, we want to continue to.

Utilize that with additional products.

So that is our intent and we have a strong balance sheet to execute on that.

Thank you.

Thanks.

Thank you Andrew we will take our next question from Jay Olson with Oppenheimer. Please go ahead.

Oh, Hey, congrats on the quarter and thank you for taking the question.

Can you talk about your lifecycle management plan for <unk>, and HD with regards to new patients and.

Adam Zaeske: Yeah. Thanks, Jeff. Thanks for the question, David. Look, we're excited about orexins, obviously, because we have one of our own, but obviously, it's also an important potential new treatment option for patients. We remain confident in our ability to grow and perform with Wakix well into the future. There are a couple of reasons for that. The first is just the approach to therapy in this market. The hallmark of treatment is polypharmacy. You have a high majority of patients that are on two or more therapies, and that will continue. We've recently verified that in market research that we've done, speaking with physicians, and they expect that to continue as well. Also, if you just look at the history of Wakix, Wakix performance has been extremely steady regardless of new entrants, whether it's brands or generics. We would expect that to continue as well.

And then which patients currently on <unk> are the best candidates to benefit from GR and Ht.

And then for your Orexin two program.

What would you like to learn from your Phase one study in.

Any lessons learned from the alkermes and Takeda data at World sleep.

Yes.

Yes, good morning, Jay Thanks for your questions, Adam our lifecycle management strategy with regards to.

Patients that would benefit from a formulation that we're really excited about this new lifecycle management formulations, the GRM HD <unk> kind of a fast to market strategy.

And the strategy there would be any patient any new patients that would've been prescribed <unk> would be prescribed.

Adam Zaeske: In fact, if you look at kind of the narcolepsy market in total, anytime there's been a new brand entrant, it tends to expand brand utilization. We would expect a similar phenomenon with an orexin launch when those come to market. We are also highly confident just because Wakix is a highly differentiated product. Early non-scheduled treatment options. Physicians will have had seven, eight-plus years of clinical experience by the time of orexin's launch in it. It holds a unique position in the minds of healthcare providers. They're highly familiar with it, provides strong efficacy, and they believe it's very well tolerated, so it can be added to combinations of therapies across a very broad selection of narcolepsy patients. That will continue as well. It will continue to hold that position.

The new.

<unk> formulations as well as.

We have the ability because we believe we obtained consents from patients when they start waking therapy. We would also be able to re contact patients that may have been on <unk> previously but have discontinued.

To see if <unk> could be an option for them to consider as well so for <unk>, it's really around new <unk> patients.

Patients in previous patients.

The foundation of wix's performance is always been the unique position of wix's owns as the only non-scheduled treatment option. Resulting in, its broad clinical utility

And then where the HD comes in.

With a greatly differentiated profile.

You would see the strategy, they're focusing on not only new weightings patients and previous patients, but also existing <unk> patients and thats, where the transition potential comes in that we have.

<unk> conducted market research around this hcp's respond very favorably to the profile of HD they viewed as clinically.

Adam Zaeske: For those reasons, I think we're very confident in our continued growth and performance well into the future.

Significantly differ.

David Amsellem: Okay, thank you.

A differentiator.

Jeffrey Dayno: Thanks, David.

Actually superior.

Operator: Thank you. We will take our next question from Greg Zivanovezh with Mizuho. Please go ahead. Your line is open.

Market research that they would consider transitioning the majority of their patients that maybe are.

Wix enjoys extremely high brand awareness is perceived as efficacious and well, tolerated and is supported by broad payer coverage that has remained consistent for years.

Adam zaeske, Chief commercial officer, Dr. Kumar Boudoir. Chief medical and science of the officer and Sandy kapadia Chief Financial and administrative officer.

In addition to this, I'd like to highlight some recent areas of focus.

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 our actual results May differ materially. And we undertake no obligation to update these statements. Even if circumstances change

We have adjusted our field sales deployment.

Better, but not well.

Sandip Kapadia: Hey, good morning. Thanks for taking my question, and congrats on the progress. One question for me, just going back to the 2025 guidance. It was nice to see a raising of the guidance, but if you do the math, it does imply fourth quarter sales for Wakix in the range of, I think, $221 to 241 million. On a quarter-over-quarter basis, that's essentially flat or down on a quarter-over-quarter basis. Can you just provide more color in how we should be thinking about whether it's net patient adds, gross to net, or seasonality when trying to model fourth quarter? I know you, Sandip, had mentioned some inventory could be a factor, but any other color would be great on the fourth quarter, especially given the great momentum on net patient adds.

Call plan and messaging, and continue to deliver sound sales execution.

We've refined our promotion and messaging we've secured important new payer coverage wins which continue to expand our already broad payer coverage.

And so thats the strategy with HD.

And then both formulations have utility patents filed through 2044, so it really allows us to expand and extend our sleep wake franchise well into the future.

Thanks.

In terms of a reference to that.

For him learnings from some of the other development program sure. Thank you Jeff Good morning, Jay and thank you for the question yes.

Yes, we are on track to initiate the phase one study.

Since two receptor agonist this quarter.

We have disclosed in the past, we will be starting a healthy volunteers single ascending dose study.

Jeffrey Dayno: Yeah. Hi. Thanks for the question. Again, I think we saw great demand in terms of top-line growth that we expect to continue as we go from Q3 to Q4 as well. I think, as I mentioned, we did see a few days of trade inventory increase in Q3, which impacted the sales positively. Just as I mentioned in Q2, it was quite the other way, the other direction. Right now, I mean, we feel very good about the range that we've put out there. We recently raised it, as you mentioned. This gives us great confidence. I'm sure, like every team, I mean, we'll do everything we can to certainly not only meet but potentially exceed the range as well. Again, it's hard to predict Q4 because there are typical variabilities as you come to Q4, especially around grand and holidays and so forth.

Andy and Paolo we will be conducting.

<unk> healthy volunteer study to bracket the door.

And we are closely watching the data that came out of Congress.

Some other products.

Especially as it relates to dosing and safety and.

Our ability profile alongside the efficacy.

Hi.

Most important to us.

Based on on the publicly available data and it lends itself to.

The center.

Okay.

<unk> graphics hypersomnia at really low dose, providing the dosing flexibility to target is to be the case and we are also trying to see how we can accelerate our own program based on the data that is coming from the other products into some type of agonist and you'll be hearing more.

Jeffrey Dayno: Again, we feel good about where it is. It's very robust growth year over year. It's going to be robust growth over prior year. We see, again, Wakix very quickly approaching blockbuster status as we go into 2026 and beyond.

More from our own products that are going to be initiated.

We 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, Dr. Jeffrey Dana, Jeff.

And we have made improvements in how we support patients moving from a wage prescription to dispense.

The first in human study and we also anticipate to share some of the clinical data in 2026. Thank you.

Super helpful. Thanks, again, congrats on the quarter.

Sandip Kapadia: Great. If I can ask a follow-up, just your net cash position is building quite nicely. I'm sure there are various views on how to deploy that cash. Wondering if maybe, in an answer that might be slightly different from David's question on BD, what are your kind of current thoughts on how best to deploy that nicely accruing cash balance?

Thanks Jay.

Okay.

Thank you and we will take our next question from Pete Stavropoulos with Cantor Fitzgerald. Please go ahead.

Good morning, and congratulations on the progress and thank you for taking my question.

Could you just touch on EPS of 100 epilepsy program any clinical data that has been generated and disclosed that's what gives you confidence in the duvet and Lgs program.

Jeffrey Dayno: Yeah, sure. I mean, look. As Jeff mentioned, I mean, we continue to look for business development opportunities. I think we have had something that's been a strategy for us for many years now. We see attractive opportunities out there that we could potentially transact. We have, again, continued growth in terms of cash. We had very strong cash generation last quarter of $106 million, $778 million at the end of the quarter. I think that gives us increasing confidence. Again, we're going to be, I would say, thoughtful in terms of how we deploy our capital. I think we certainly have multiple ways in which to drive value for shareholders. Certainly, more recently, we've been prioritizing business development. In the past, we've also done share buyback as well as an opportunity.

Any details on efficacy durability and safety and can you also give us a sense of how enrollment is going into phase III studies.

Any granularity on timing of data or when you expect to complete enrollment.

Thanks.

Good morning, Pete Thanks for your questions.

I will turn to Kumar for some more color on the.

EPS program, Yes, good morning paid and thank you for the question, Yes, I mean, we are excited to share some of the efficacy data at the upcoming American Epilepsy Society meeting.

In December.

As I mentioned earlier in the call we will be sharing the data from the August will can label extension study a study in <unk> syndrome.

In terms of your question, our own recruitment and enrollment, yes, I mean, we continue to recruit patients.

Jeffrey Dayno: At the right time, we'll look at various opportunities to drive value for shareholders.

In both August study and delight home study and Lgs studies, and we anticipate sharing top line data in 2026.

Jeffrey Dayno: Yeah. Thank you. Oh, Greg, I'll just go ahead. No, no. I appreciate the question. I just want to reiterate, I think, while one can never predict the timing in terms of business development transactions, as Sandip alluded to, we have optionality. Our focus and our intent is really to pursue innovative, value-enhancing assets. We want to build our pipeline. We see that's where the value is going forward, as well as build a broader product portfolio. In terms of, we have a strong commercial engine. We want to continue to utilize that with additional products. That is our intent, and we have a strong balance sheet to execute on that. Thank you.

We will be providing more granularity.

Granularity in terms of timeline.

Okay.

With the enrollment.

Thank you.

And any thoughts on taking a 100 into other <unk> or other <unk> remains the focus of 200.

Yes.

Good question. Thank you.

This discussion around.

Lvs, what's being separately was going with the broader be indications right so bit of growth and cost with each of these approaches.

Focused laser focused on through a syndrome Lennox <unk> syndrome, we wanted to keep it that way mainly to maintain the homogeneity of the patient population and tried to get to the top line data as soon as possible and plan to have this patient group.

Thank you, Matt.

Profile.

With a very favorable not just from an efficacy perspective, but also from a safety and Tolerability perspective.

Jeffrey Dayno: Thanks.

Operator: Thank you. We will take our next question from Jay Olson with Oppenheimer. Please go ahead.

And Pete maybe one one addition to stick to remind everyone. So EPS 100 <unk> hydrochloride.

Adam Zaeske: Oh, hey, congrats on the quarter, and thank you for taking the question. Can you talk about your life cycle management plan for Pitolisant GR and HD with regards to new patients? Which patients currently on Wakix are the best candidates to benefit from GR and HD? For your BP1.15205 program, what would you like to learn from your phase one study, and any lessons learned from the Alchemies and Cata data at World Sleep? Thank you.

Our first generation antihistamine.

Within the market for about 20 years with a proven safety tolerability profile and in the overall sort of risk benefit in these on.

Therapeutic options.

With other.

Indicated agents such as at the dialects and the need to monitor LLC or fin Tesla.

With the Echocardiograms required in the Rins program because of cardiac valvular disease. The risks there. So there is sort of a proven safety and tolerability profile and in the overall kind of risk benefit.

Sandip Kapadia: Yeah. Good morning, Jay. Thanks for your questions. Adam, our life cycle management strategy with regards to patients that would benefit from those formulations.

Adam Zaeske: Yeah, we're really excited about the two life cycle management formulations, the GR and the HD. GR is kind of a fast-to-market strategy. The strategy there would be any new patients that would have been prescribed Wakix would be prescribed the new pitolisant GR formulation, as well as we have the ability because we obtained consent from patients when they start Wakix therapy. We would also be able to recontact patients that may have been on Wakix previously but had discontinued to see if pitolisant GR could be an option for them to consider as well. For GR, it's really around new Wakix patients and previous patients. Where the HD comes in, with a greatly differentiated profile, we would see the strategy there focusing on not only new Wakix patients and previous patients, but also existing Wakix patients.

We see the opportunity there as we go forward and generate efficacy data in both Dravet and lgs.

Alright, Thank you very much and congratulations once again.

Thank you.

Thank you and we will take our next question from Danielle <unk> with <unk> Securities. Please go ahead.

Hey, guys. Good morning, congrats on the quarter and thanks for the question.

Maybe just two quick ones from me do you have any sense of what proportion of your 8100 patient base is empty one versus <unk> and then what findings if any in the fragile X data that would make you consider re activating the Q2.

22 trial. Thank you.

Good morning, Danielle Thanks for your questions.

Adam breakdown.

Patients on Lakehead sure. Thanks for the question, it's been a very consistent actually for the last several years, we see about 45% of patients.

Adam Zaeske: That's where the transition potential comes in. We've conducted market research around this. HCPs respond very favorably to the profile of HD. They view it as clinically, significantly differentiated, actually superior. In market research, they tell us they would consider transitioning a majority of their patients that maybe are better but not well. That's the strategy with HD. Both formulations have utility patents filed through 2044. It really allows us to expand and extend our sleep/wake franchise well into the future.

From <unk>, 155% from <unk> and Thats been very stable.

Okay.

Similar yes, Danielle good morning, and thank you for the question. We are right now conducting an in depth review of all the data from the reconnect study.

As mentioned previously.

The fragile X syndrome study did not read out.

<unk>, mainly because of the larger than anticipated placebo response.

Right now we are conducting a number of post hoc analysis.

Hard to say at this point in time, what kind of data that we need to see before we embark upon 2000 <unk> deletion syndrome phase three study once all these data sets are available we will make a decision based on the data.

Good morning everyone. And thank you for joining our call today.

Reflected in higher rates of conversion, and shorter times to dispense.

I want to start off by saying how proud I am of the harmony team and their exceptional performance, this quarter.

Jeffrey Dayno: Thanks. In terms of our Erection 2 access program and learnings from some of the other development programs.

Adam Zaeske: Sure. Thank you, Jeff. Good morning, Jay, and thank you for the question. Yes, we are on track to initiate the phase one study with our orexin 2 receptor agonist this quarter. As we have disclosed in the past, we will be starting a healthy volunteer single ascending dose study. In parallel, we'll be conducting a sleep-deprived healthy volunteer study as well to bracket the dose a bit. We are closely watching the data that came out of World Sleep Congress from other orexin receptor agonists, especially as it relates to dosing and the safety and tolerability profile alongside the efficacy. We have one of the most potent orexin receptor agonists based on all the publicly available data, and it lends itself to target decentralized on narcolepsy type 2 and idiopathic hypersomnia at very low dose, providing us the dosing flexibility to target these three indications.

Alright.

We should be able to complete this work by the end of this year and we should be able to provide some update on the <unk> syndrome study itself and also the implications on 20 <unk> deletion syndrome early next year.

Daniel.

Thank you.

Thanks Danielle.

Much of what we're focused on are the fundamentals.

Thank you and we will take our next question from Karen Johnson with Goldman Sachs. Please go ahead.

Hi, This is Andrew on behalf of coding.

Maybe one question for Mark can you talk about the effect size you are powering for the phase III <unk>.

Study to show on Esa scale, and what do you think a clinically meaningful difference would be in comparison to the current way kicks in order to support DHT use I think the week. It's shown around 12 to 13 point finally assay score any color on that.

Hey.

Good morning. Thank you for the call. Thank you for the question I'll, let gummy katana HD, it's an enhanced formulation.

Adam Zaeske: We are also trying to see how we can accelerate our own program based on the data that is coming out from the other orexin receptor agonists. You'll be hearing more from our own orexin receptor agonist when we initiate the first-in-human study. We also anticipate to share some of the clinical data in 2026. Thank you, Jay. Super helpful. Thanks again. Congrats on the quarter.

Yes.

Nextgen formulation, it's not just the hydro, but it's also it also has an optimized PK profile.

Just on the fifth.

But we have seen.

One other thing in the Kyoto Narcoleptic chemical plants and also the studies that we conducted in product Willi syndromes and also in the myotonia dystrophy.

And the dose exposure and the exposure of data some of the exposure response data that we have.

Jeffrey Dayno: Thanks, Jay.

Anticipate a meaningful increase in the efficacy from an exclusivity event keeping the prospect deal.

Operator: Thank you. We will take our next question from Pete Stavropulos with Cantor Fitzgerald. Please go ahead.

But it's also important to note that we are not just targeting a daytime sleepiness. We are also targeting fatigue in patients with narcolepsy.

David Amsellem: Good morning and congratulations on the progress, and thank you for taking my questions. Could you just touch on EPX-100 epilepsy program? Any clinical data that has been generated and disclosed that sort of gives you confidence in the Dravet and LGS program? Any details on efficacy, durability, and safety? Can you also give us a sense of how enrollment is going in the phase 3 studies? Any granularity on timing of data or when you expect to complete enrollment? Thanks.

There are no approved treatments.

We are also targeting sleepiness year in patients with idiopathic hypersomnia.

There are no approved treatment.

And we plan to accomplish all of this without compromising on the safety and Tolerability profile.

All of them in fact, we conducted a phase one B study. We studied we don't pick up to 180 milligram, which is up to five times.

Jeffrey Dayno: Good morning, Pete. Thanks for your questions. I'll turn to Kumar for some more color on the EPX program.

The maximum label dose of <unk>.

Adam Zaeske: Yeah. Good morning, Pete, and thank you for the question. Yes, I mean, we are excited to share some of the efficacy data at the upcoming American Epilepsy Society meeting in December. As I mentioned earlier in the call, we will be sharing the data from the Argus open-label extension study. That's the study in Dravet syndrome. In terms of your question around recruitment and enrollment, yes, I mean, we continue to recruit patients in both Argus study and the Lighthouse study. That's Dravet and LGS studies. We anticipate to share top-line data in 2026. We'll be providing more granularity in terms of timelines as we progress with the enrollment. Thank you.

And the safety and Tolerability profile in general was similar to what we see with <unk>. So what it means at the end of the day is a very unique benefit with economic growth.

With the established safety profile established Tolerability profiles logged in efficacy.

Targeted symptoms like fatigue in narcolepsy targeting cintra sleepiness.

Sleepiness in patients with idiopathic hypersomnia, all while maintaining in Nonscheduled startup and a very simple dosing regimen of baking sale.

In the morning, but thats, what we plan to accomplish with <unk>.

Thank you.

Okay. Thank you.

Thank you and we will take our next question from Patrick <unk> with H C. Wainwright. Please go ahead.

David Amsellem: Any thoughts on taking 100 into other DEs, or other DEs remain the focus of 200?

Good morning.

I'm wondering if you can elaborate a bit more on me.

Adam Zaeske: Yeah, Pete, great question. Thank you. Look, there is this discussion around DS, LDS, pursuing separately versus going with a broader DE indication, right? There are pros and cons with each of these approaches. Right now, we are focused, laser-focused on Dravet syndrome and Lennox-Gastaut syndrome. We want to keep it that way, mainly to maintain the homogeneity of the patient population and try to get to the top-line data as soon as possible and try and help these patients with a product profile, which is very favorable, not just from an efficacy perspective, but also from a safety and tolerability perspective. Thank you.

Sustainability and as well the drivers of the record approximate 500 patient out in the third quarter and if we should expect those drivers to continue in the fourth quarter, but it was in 2026 and then separately on the <unk>.

Thank you mentioned strong early feedback from physicians and payers I'm wondering if you could elaborate on what's resonating most and as well the implications for the phase III development program.

And good morning, Patrick Thank you for your questions Adam.

Yes. Thank you for the question. So we're really pleased with the momentum we're seeing in increases in patient adds as you mentioned.

And the drivers.

Jeffrey Dayno: Yeah. Pete, maybe one addition just to remind everyone. EPX-100, clemizole hydrochloride, is a first-generation antihistamine that was in the market for about 20 years with a proven safety tolerability profile. In the overall sort of risk-benefit in these sort of therapeutic options with other indicated agents, such as Epidiolex and the need to monitor LFTs, or Fintepla with echocardiograms required in the REMS program because of cardiac valvular disease, the risk there. There is sort of a proven safety tolerability profile. In the overall kind of risk-benefit, we see the opportunity there as we go forward and generate efficacy data in both Dravet and LGS.

Look I think it starts with <unk> is a highly differentiated product, it's the only non scheduled treatment option.

And that is combined with strong execution across the organization. So.

And if you think about sales effectiveness and execution.

Marketing and promotional excellence payer coverage patient support.

We've made adjustments in all of these areas.

And we're seeing those adjustments.

Delivering the performance that you're seeing in and have confidence that.

That momentum will definitely carry forward in Q4 and into 2026.

Okay and.

Patrick Your second question, yes, so around the HD and so what resonates.

From sales, execution, marketing and promotion, payer coverage and patient support.

It resonates is the promise of improved efficacy.

David Amsellem: Thank you very much, and congratulations once again.

The the <unk>.

No titration, starting at a therapeutic dose and unique indications, especially around.

Jeffrey Dayno: Thank you.

Operator: Thank you. We will take our next question from Danielle Brill with Truist Securities. Please go ahead.

H and fatigue, we know that 60% of narcolepsy patients present with fatigue. This would be the only product that has the indication for fatigue and narcolepsy.

Danielle Brill: Hi guys. Good morning. Congrats on the quarter, and thanks for the question. Maybe just two quick ones from me. Do you have any sense of what proportion of your 8,100 patient base is NT1 versus NT2? What findings, if any, in the Fragile X data set would make you consider reactivating the Q22 trial? Thank you.

And I view that as highly differentiated so I mentioned the feedback from Hcp's, but we've also done research with Payors.

And the responses that we would expect broad payer coverage for the HD product.

It reaffirms harmonies reputation for executional excellence.

The adjustments we are making are delivering results and we will continue to look for additional opportunities in all areas moving forward.

With minimal step edits through for <unk> or no step edits actually in prior to low and even after a low.

Only some mentions of perhaps some step edits, but only for patients that have never had any experience on <unk> before.

Jeffrey Dayno: Good morning, Danielle. Thanks for your questions. Adam, breakdown of patients on Wakix?

At this point.

Adam Zaeske: Sure. Thanks for the question. It's been very consistent, actually, for the last several years. We see about 45% of patients from NT1, 55% from NT2, and that's been very stable.

I guess it will be at what eight plus years in the market by them.

Majority of patients will have had some experience with <unk> at some point in the past.

And then of course any patient that presents with fatigue would also not be subject to any step edits.

Jeffrey Dayno: Okay. Kumar?

Adam Zaeske: Yeah. Danielle, good morning, and thank you for the question. We are right now conducting an in-depth review of all the data from the RECONNECT study. As mentioned previously, the Fragile X syndrome study did not read out as expected, mainly because of the larger-than-anticipated placebo response. Right now, we are conducting a number of post-hoc analyses. It's very hard to say at this point in time what kind of data sets we need to see before we embark upon 22q deletion syndrome phase 3 study. Once all these data sets are available, we will make a decision based on the data that we see. We should be able to complete this work by the end of this year, and we should be able to provide some update on the Fragile X syndrome study itself, and also the implications on 22q deletion syndrome early next year. Thank you, Danielle.

Three weeks, even posted low so we would expect broad payer coverage pre and post Halloween supporting the product.

Thank you.

Ken.

Thank you Andrew we will take our next question from Jason <unk> with Bank of America. Please go ahead.

Hey, guys. This is Damon on for Jason just two questions from US. The first design EP ex 100, you have two phase three readouts expected in 2026, and maybe you can just speak to what you've learned from the fragile X syndrome as well as the prior idiopathic Hypersomnia study about managing placebo response in these types of.

Our developmental studies and then the second question is on <unk> can you just speak to where new patient growth is coming from are you activating new prescribers or is the growth primarily from deeper penetration within existing measures. Thank you.

Thanks, Bob for your question on Kumar on EPS 100, Yes, Hey, good morning, Gary.

Danielle Brill: Thank you.

Jeffrey Dayno: Thanks, Danielle.

Operator: Thank you. We will take our next question from Corinne Johnson with Goldman Sachs. Please go ahead.

Thank you for the question <unk> hundred <unk> know, what we're studying here.

The seizure frequency.

Anupam: Hi, this is Anupam on behalf of Corinne. Maybe one question for Kumar. Can you talk about the effect size you are parsing for the phase 3 pitolisant HD study to show on ESS scale? What do you think a clinically meaningful difference would be in comparison to the current Wakix in order to support the HD use? I think the Wakix shown around 12 to 13 point final ESS score. Any color on that?

Which is slightly different from what we studied.

Paul.

Zero zero zero.

In the fragile X syndrome, a placebo response in general is part and parcel of volume growth like pile, especially pipe pilots with behavioral endpoint.

<unk> syndrome.

We had multiple components.

We think thats starting to manage the placebo response.

Adam Zaeske: Hey, good morning. Thank you for the call. Thank you for the question. Look, I mean, pitolisant HD, it's an enhanced formulation. It's an enhanced next-gen formulation. It's not just the high dose, it also has an optimized PK profile. Based on the dose response that we have seen with pitolisant in the pivotal narcolepsy clinical trials and also the studies that we conducted in Prader-Willi syndromes and also in myotonic dystrophy, and the exposure response data, some of the exposure response data that we have, we anticipate a meaningful increase in the efficacy from an excessive daytime sleepiness perspective. It's also important to note that we are not just targeting excessive daytime sleepiness. We are also targeting fatigue in patients with narcolepsy, for which there are no approved treatments.

With <unk> 100 is slightly different in defense.

As a frequency.

<unk>.

Much more observable.

Much more definitive compared to some of the behavioral symptoms for these two distinct indications.

Distinct endpoints.

But to your point in.

In general yes.

But to put it can hop in any clinical trial and that's something that we are launching and we have six involvement with our 100 August at lighthouse clinical plan to talk about.

Okay.

Adam Yes, and then in terms of Wix, new patients. So the short answer to your question as we see.

Both new patients from increased penetration of existing riders as well as the addition of new writers.

We see quarter over quarter pretty steady increasingly writers every quarter.

Adam Zaeske: We are also targeting sleep inertia in patients with idiopathic hypersomnia, for which there are no approved treatments. We plan to accomplish all of this without compromising on the safety or tolerability profile of pitolisant. In fact, we conducted a phase 1b study where we studied pitolisant up to 180mg, which is up to five times the maximum labeled dose of Wakix. The safety and tolerability profile in general was similar to what we see with Wakix. What it means at the end of the day is a very unique benefit-risk analysis with established safety profile, established tolerability profile, larger efficacy in excessive daytime sleepiness, targeting symptoms like fatigue in narcolepsy, targeting symptoms like sleep inertia in patients with idiopathic hypersomnia, all while maintaining the non-scheduled status and a very simple dosing regimen of taking a pill in the morning.

That's.

Continued for the past several years and we would expect that to continue.

A little bit more detail remember, we we call on and actually more than 9000 physicians and that's that's 4000 that are enrolled in the oxalate rems programs, but also more than 5000 that are not enrolled and oxalate rems programs. We have the ability to call on both of those sets physicians and in both instances, we see increased penetration is.

Well as.

New writers.

Yes, and I will take that.

Yes.

Thank you for your question I just to add.

At a higher level just to remind everyone that this is a large this is a large market. So in terms of the continued growth of <unk>, a highly differentiated product profile with broad clinical utility.

The only non scheduled product which is meaningful.

As a former neurologist treating patients very meaningful in terms of therapeutic option, but.

Adam Zaeske: That's what we plan to accomplish with pitolisant HD. Thank you.

This sizable market 80000 patients.

Patients diagnosed so as this market evolves and grows and more understanding.

Anupam: Okay. Thank you.

Operator: Thank you. We will take our next question from Patrick Trucio with HC Wainwright. Please go ahead.

Similar with.

The learning about fatigue is a prominent symptoms in patients with narcolepsy about 60%, so dump designing that into the consultant HD program.

Patrick Trucchio: Thanks. Good morning. I was wondering if you could elaborate a bit more on the sustainability, and as well the drivers of that record, approximate 500 patient add in the third quarter, if we should expect those drivers to continue in the fourth quarter, as well as in 2026. Then separately on pitolisant HD, I think you mentioned strong early feedback from physicians and payers. I'm wondering if you could elaborate on what's resonating most, and as well the implications for the phase 3 development program.

So I think that as the backdrop why we are confident.

Hi.

The underlying fundamentals and the growth of <unk>.

And narcolepsy.

And our excitement and confidence and propel us in HD program in <unk>.

I think that has a lot to do with it as well.

It's a great point Jeff.

We're at 8100 average patients now in <unk>.

Market of over 80000 diagnosed patients obviously, we have a lot of room to continue to grow and also in a polypharmacy market I think you're all familiar with.

Jeffrey Dayno: Yeah. Good morning, Patrick. Thank you for your questions. Adam?

Adam Zaeske: Yeah. Thank you for the question. We're really pleased with the momentum we're seeing in increases in patient adds, as you mentioned. The drivers, look, I think it starts with Wakix is a highly differentiated product. It's the only non-scheduled treatment option. That is combined with strong execution across the organization. If you think about sales effectiveness and execution, marketing and promotional excellence, payer coverage, patient support, we've made adjustments in all of these areas. We're seeing those adjustments delivering the performance that you're seeing and have confidence that that momentum will definitely carry forward in Q4 and into 2026.

<unk> any chronic neurologic disorders, it's rare that a single mechanism of action will.

We will be able to treat.

Difficult to treat chronic symptoms.

I think this is this is what we're seeing is wages continues to grow.

Okay.

Thank you.

Thank you and we will take our next question from Ashwin <unk> with UBS. Please go ahead.

Hi, yes, thanks for taking questions from us. So maybe just I'm wondering if you could give me just thoughts on how youre thinking about the overall pipeline and diversification you've seen two different setbacks recently for us on the <unk> side and then on <unk>. What gives you the confidence that the subsequent pipeline fill brands have higher retention.

As we have shared, Q3 was a very strong quarter for harmony.

Jeffrey Dayno: Okay. Patrick, your second question?

The success.

And then on the matrix 1 billion guide is that something that you can achieve in 2026, just at the pace at which you're growing and therefore to us and what I had.

Adam Zaeske: Yeah. Around the HD and what resonates is the promise of improved efficacy, no titration starting at a therapeutic dose, and unique indications, especially around IH and fatigue. We know that 60% of narcolepsy patients present with fatigue. This would be the only product that has the indication for fatigue in narcolepsy, and they view that as highly differentiated. I mentioned the feedback from HCPs, but we've also done research with payers. The response is that we would expect broad payer coverage for the HD product with minimal step edits for Wakix or no step edits, actually, prior to LOE and even after LOE. Only some mentions of perhaps some step edits, but only for patients that have never had any experience on Wakix before, which at this point, I guess, will be at, what, eight-plus years in the market by then.

As we look to the fourth quarter of 2025, we expect continued growth in average number of patients and momentum.

Indicators of X and expected to launch in <unk>.

27, what's your level of urgency to hit the long term guidance before the competitor entry.

Yes. Thank you.

Start with the first question about our pipeline and I just want to reiterate that.

We continue to have strong conviction in our pipeline programs.

<unk> leadership, and our R&D organization, which has a lot of experience and expertise.

We don't have time, but if you look at each other if you look at the IH study if you look at fragile X.

There are good reasons in terms of the outcomes.

That we've sort of talked about.

In the <unk> program.

In talking with Kols on unfortunately that pattern.

Adam Zaeske: The vast majority of patients will have had some experience with Wakix at some point in the past. Of course, any patient that presents with fatigue would also not be subject to any step edits through Wakix, even post-LOE. We would expect broad payer coverage pre- and post-LOE, supporting the product and its uptake.

Programs, where they were a positive phase III data and a lot of expectation because there are no approved treatments.

And a high placebo response rate.

Got into multiple phase III programs, which is the reason why not have been successful we have learnings from that and we will take those learnings going forward.

Jeffrey Dayno: Thank you, Adam.

Operator: Thank you. We will take our next question from Jason Gerberry with Bank of America. Please go ahead.

But I think I continue to have conviction.

<unk> hundred our other pipeline programs and Kumar any additional thoughts thank you Connor.

Bhavan: Hey, guys. This is Bhavan on for Jason. Just two questions from us. The first is on EPX100. You have two phase 3 readouts expected in 2026. Maybe if you can just speak to what you've learned from the Fragile X syndrome as well as the prior idiopathic hypersomnia study about managing placebo response in these types of neurodevelopmental studies. The second question is on Wakix. Can you just speak to where new patient growth is coming from? Are you activating new prescribers, or is the growth primarily from deeper penetration within existing writers? Thank you.

Thank you.

Yeah, and then thanks for the question around.

Achieving $1 billion in revenue and obviously, it's a little bit premature to provide guidance for 2026, specifically, but.

But we're seeing very strong momentum as we saw in Q3 and in Q2, we would expect that momentum to continue in Q4 and well into 2026.

We're confident we will achieve a $1 billion in revenue well before Hello.

So.

Sure.

Yes confidence remains high.

Jeffrey Dayno: Thanks, Bhavan, for your question. Kumar on EPX100?

Thanks, Adam Thanks, Matt.

Adam Zaeske: Yeah. Hey, good morning, Warren. Thank you for the question. With EPX-100, I mean, as you know, what we are studying here is the seizure frequency, which is slightly different from what we studied with ZYN002 in the Fragile X syndrome. Placebo response, in general, is part and parcel of all neuropsych trials, especially psych trials with behavioral endpoints like Fragile X syndrome. We had multiple checks and balances within the study to manage the placebo response. With EPX-100, it's slightly different in the sense seizure frequency is much more observable and much more definitive compared to some of the behavioral symptoms. These are two distinct indications with distinct endpoints. To your point, in general, yes, I mean, placebo response can happen in any clinical trials, and that's something that we are watching.

Thank you Andrew we will take our next question from David <unk> with Deutsche Bank. Please go ahead.

Hi, there thanks for taking the questions.

I wanted to ask on eligible patients for <unk>, sorry, the <unk> HD and CR I think for HD, you mentioned, new previous and switch patients I think are on the table.

Just wondering what in your mind defines.

A good sleep patients for going from <unk> to HD, and then is switching with switching dean option for GR patients. Thanks.

Thanks for the question.

So I guess the.

The switch patients obviously, that's going to be determined by the health care provider, but we know that 75% of patients with narcolepsy continue to struggle with residual symptoms.

We reported 239.5 million in net revenue for the quarter.

Representing 29% growth year on year.

And so if we're if we're able to offer the HD product with an improved efficacy profile, but the same safety and tolerability profile that they are very familiar with <unk>, we would expect to hcp's to consider their patients that potentially could benefit.

As a result, we recently raised our full year Revenue, guidance of 820 to 860 million to the high end of the range between 8:45 and 865 million and we are rapidly approaching achieving a billion dollars plus in annual revenue from narcolepsy alone.

and with this momentum, we recently raised our net revenue guidance for the year from 820 to 860 million, taking it up to 845 to 865 million,

We had robust cash, generation of 106 million bringing our balance sheet to 778 million as of September 30th.

Benefit from a boost in efficacy.

Adam Zaeske: We have checks and balances with our EPX100 Argus and Lighthouse clinical trials as well.

Confident that there won't be address introducing any new safety or tolerability issues.

And also any patients that present with fatigue and as I mentioned before we know that 60% of patients with narcolepsy do present with fatigue those would be prime candidates.

Jeffrey Dayno: Okay. Adam?

Adam Zaeske: Yeah. In terms of Wakix new patients, the short answer to your question is we see both new patients from increased penetration of existing writers, as well as the addition of new writers. We see quarter over quarter a pretty steady increase in new writers every quarter, and that's continued for the past several years. We would expect that to continue. A little bit more detail, remember, we call on actually more than 9,000 physicians, and that's 4,000 that are enrolled in the Oxybate REMS programs, but also more than 5,000 that are not enrolled in Oxybate REMS programs. We have the ability to call on both of those sets of physicians, and in both instances, we see increased penetration as well as new writers.

Looking to the Future. The poll is in gr and HD formulations each Target significant unmet patient needs while extending our growth potential with utility patents filed through 2044.

For the HD as well and then for the GR, Yes switch would be an option certainly for the health care provider.

But what I am most proud of is that this performance was driven by the highest number of quarterly patient ads for Wake X since our launch.

In terms of our strategy will be focused on new patients in previous patients as I mentioned before.

Thank you.

And Im showing no further questions I would now like to turn the call back for any closing remarks.

Thanks, operator.

Early feedback from Physicians and payers on the HD formulation has been particularly encouraging.

On behalf of the harmony team I want to thank everyone for joining our call today and for your interest in harmony Biosciences.

Have a great rest of your day thank.

Jeffrey Dayno: Yeah. I would just add, yeah. No, thank you for your question. Just to add, at a higher level, just to remind everyone that this is a large market. In terms of the continued growth of Wakix, a highly differentiated product profile with broad clinical utility, the only non-scheduled product, which is meaningful. As a former neurologist treating patients, very meaningful in terms of therapeutic options, but in a sizable market, 80,000 patients diagnosed. As this market evolves and grows and more understanding, similar with the learning about fatigue as a prominent symptom in patients with narcolepsy, about 60%. Designing that into the pitolisant HD program. I think that is the backdrop, why we are confident, why. The underlying fundamentals and the growth of Wakix in narcolepsy, and our excitement and confidence in the pitolisant HD program and pitolisant GR.

Thank you.

This does conclude today's harmony Biosciences Sciences third quarter 2025 financial results Conference call. You May now disconnect your line and have a one.

With an average of 500 patients added this quarter.

And we will be able to leverage our commercial infrastructure to drive the next phase of growth through our tools and franchise formulations.

Resulting in an average of 8,100 patients on Wix at the end of Q3.

In summary, the performance of our business has never looked better.

Our Chief Commercial Officer, Adam Zaeske, will next be providing more color on some of the things his team is doing to drive this strong momentum in our wake experience.

Fueled by a highly differentiated product.

A focus on fundamentals and excellent execution across the organization.

We are confident in our continued growth and performance moving forward.

There are many different ways to measure impact.

And now I'd like to turn the call over to our chief medical and scientific officer, Kumar Beador to discuss the advancements in our clinical development programs.

Delivering Innovative treatments to Patient. Populations living with unmet. Medical needs is a very meaningful 1.

Jeffrey Dayno: I think that has a lot to do with it as well.

Adam Zaeske: Yeah, I think it's a great point, Jeff. I mean, the fact that we're at 8,100 average patients now, in a market of over 80,000 diagnosed patients, obviously, we have a lot of room to continue to grow.

Kumar.

Blockbuster status in narcolepsy alone.

We continue to make good progress. In R&D with 3 phase 3, registration studies ongoing and anticipate up to 5 phase 3, registration studies in 5, distinct indications by the end of the year.

Along with our very strong Commercial Business. Harmony also has a robust late stage Pipeline with multiple catalysts coming over the next several years.

And we have some important updates to share on the next 10 programs.

I continued to have firm conviction in our Pipeline and full confidence in our R&D team to successfully execute on these programs.

Jeffrey Dayno: Yeah. Also, in a polypharmacy market, I think, as you're all familiar with, where any chronic neurologic disorders, it's rare that a single mechanism of action will be able to treat difficult-to-treat chronic symptoms. I think this is what we're seeing as Wakix continues to grow. Thank you.

Starting with our sleep wake franchise.

We continue to make significant progress across our next 10 to 10 programs.

and please report that we have submitted the end for pent HD to the FDA,

In fact, the IND for paulussen HD our polls in high dose, formulation has been submitted to FDA and we are on track to initiate 2. Phase 3 trials, 1 in narcolepsy, and 1 in idiopathic hypersomnia or IH before the end of the year.

The pent HD program and enhanced formulation with an optimized PK profile and higher dose.

Kumar will provide an update on our pipeline programs later in the call, including an update on the reconnect study in fragile X syndrome.

Target in enhanced efficacy for excessive data and sleep and pursuing a differentiated labor with an indication for fatigue. In our colly is on track for phase 3, initiation in Q4 2025.

Turning to balance sheet.

Similarly, the phase 3 study with PTO and HD in patients with idiopathic hypersomnia.

Is also pursuing a differentiated labor with an indication for Sleep. Inertia. And we are on track for initiation in Q4 2025.

The target in Peru for dates for both programs is in 2028.

The other next 10, formulas and gr is designed to minimize the potential for treatment related GI side effects. Especially since almost 90% of patients with narcolepsy experience, comorbid GI symptoms.

In addition petus and gr. Also provides an ability to start at the therapeutic dose range at 17.8. Mg eliminating the need for nitration,

And important differentiation.

To demonstrate this. We conducted a dosing optimization study, which is now completed.

We are excited to share that in this study patients with narcolepsy. Start at pus in gr at 17.8 mg and 100% of the patients that is all 46 or 46. Patients were able to initiate PTO in gr and the therapeutic dose of 17.8 mg with no safety or tolerability issues. In addition, 98% of the patients who received pedos and gr 35.6 mg at week 2 tolerated, the higher dose. Well, no new age or saes were observed from this study.

Petalis and gr is a fast Market strategy designed to demonstrate bioequivalence to make its formulation. The top end data. From the pivotal be study is on track for Q4, 2025 with a Target to do for in q1 2027.

Utility patents have been filed for both Peters and gr and pent HD with potential exclusivity to 2044 securing long-term franchise value.

Beyond pent. Our sleepe portfolio continues to advance with BP 1.15, 205 a highly potent, RX in 2 receptor Agonist demonstrating, best-in-class potential in pre-clinical studies.

At the recent sleep meeting in Seattle and won't keep Congress meeting in Singapore. We presented comprehensive, preclinical, safety and efficacy data. The demonstrated efficacy at very low doses, across all parameters of interest in a standard Transcendent most model.

We are on track to close the first subject later this quarter and we anticipate sharing clinical data in 2026.

In the neurobehavioral fee. As we have already disclosed the zebra and 0002 phase 3 reconnect study in frazzle, X syndrome did not meet the primary endpoint of improvement in Social avoidance mainly due to higher than expected Placebo response.

This is disappointing for Harmony and for the Fuzzel X Syndrome community, who continue to wait for approved therapies.

The indepth review of full data set is ongoing and we plan to share additional information in the near future.

The Z1 0002 program in 22 Q. Deletion Syndrome has been paused pending the full review of the reconnect data

in our epilepsy franchise, we continue to actively enroll patients in 2, Global phase 3 registration, trials with epx 100

the August study interway syndrome and the lighthouse study in Lenox Gustav syndrome,

Operator: Thank you. We will take our next question from Ash Verma with UBS. Please go ahead.

Our claim is on, hydrochloride is a 5HT2 serotonin agonist and we are enhancing serotonergic tone, an established mechanism of action for developmental and epileptic syndromes.

In addition it has a unique safety and tolerability profile. And the emerging safety profile is supportive of no requirements for additional laboratory or special safety monitoring compared to some of the drugs commonly used in these disorders.

We will be presenting some of the efficacy data from the August, open, label extension study and the safety tolerability data and epx 100 as the upcoming American epilepsy society meeting in December.

Finally, on behalf of Harmony, I would like to thank all the patients and their families who are participating in our clinical trials, as well as the clinical investigators, and find personal for their efforts, and commitment in helping us to advance our development programs.

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

Thank you, Kumar and good morning everyone. This morning, we issued our third quarter 2025 earnings release and filed our 10q or you'll find the details of our financial and operating results.

Jeffrey Dayno: Oh, hi. Yeah. Thanks for taking questions from us. Maybe just I wanted to get your latest thoughts on how you're thinking about the overall pipeline and diversification. I mean, we've seen two different setbacks recently, first on the IH side and then on Fragile X. What gives you the confidence that the subsequent pipeline programs have higher chances of success? On the Wakix $1 billion guide, is that something that you can achieve in 2026, just at the pace at which you're going and where Fortune is analyzing at? With the CADAS direction expected to launch in 2027, what's your level of urgency to hit the long-term guide before the competitor entry? Thanks.

We delivered strong financial results in the third quarter with our highest quarter to date in revenues and cash generation. Our financial performance and profile positions as well to continue advancing our growth strategy for the remainder of 2025 and Beyond.

We reported net revenues of 239.5 million compared to 186 million in the prior year quarter representing a growth of 29% year-over-year.

Growth. The growth was driven by very strong demand for wages as demonstrated by our record increase in average number of patients, along with an increase in trade inventories of a few days as we head into the fourth quarter.

We reported total operating expenses for the third quarter of 114.3 million compared to 81.6 million for the same quarter in 2024.

The expenses during the third quarter of 2025 included Investments to advance our late-stage pipeline, a 15 million dollar milestone for the completion of the enrollment of the Cyn, 0002 trial, as well as continued, commercialization of weight kicks and narcolepsy.

We also continue to show solid, net income growth.

Non-gaap adjusted net income. For the third quarter of 2025 with 63.5 million or 1.8 cents per diluted share compared to 57.3 million or 99 cents per diluted share in the prior year quarter.

We Believe non-gaap adjusted. Net income fed, a reflect the underlying business performance.

Please see our press release for a reconciliation of GAAP to non-GAAP results.

as previously mentioned Harmony entered the third quarter with a proximately 778 million,

In cash, cash, cash flow and Investments.

The balance, reflects strong, cash, generation resulting in an increase of 106 million in the third quarter.

We continue to actively pursue value, enhancing strategic opportunities, to deploy our Capital to expand our portfolio and drive value for shareholders.

Looking ahead in 2025, our strong performance, through Q3 gives us increasing confidence in our fully our output.

We recently raised our Revenue guidance from 820 to 860 million to 845 to 865 million.

These results also gives us confidence that we are rapidly approaching Blockbuster status, for a way kicks in narcolepsy alone.

With respect to expenses, we expect continued investment in R&D as we advance. Our late stage Pipeline with the start of 2 phase 3 studies for our paulussen HD programs.

As a result, we expect to have 5 ongoing phase 3, registrational programs by the end of the year.

in addition, we also expect a milestone of 4 million dollars in Q4 related to the initiation of our Phase 1 trial in our eruption to aegon program

In summary, we had very strong results for the this quarter.

along with

positive momentum going into Q4.

Value for shareholders.

And with that, I'll turn the call back over to Jeff for his closing remarks Jeff.

Thank you Sandeep.

And my thanks to everyone for joining our call today and for your interest in harmony biosciences.

In closing.

I am very proud of our teams exceptional performance in the third quarter and energized by our progress.

Let me highlight a few key points to leave you with.

First we delivered a very strong quarter with 29% year-on-year Revenue. Growth driven by a record number of an average of 500, new patients ads for the quarter.

With this sustained momentum.

We Believe Wix is rapidly approaching a 1, a 1 billion dollar plus Blockbuster status in narcolepsy alone.

Looking ahead.

Our late stage pipeline remains robust and I continue to have strong conviction in our pipeline programs, which are making excellent progress.

Lastly, we continue to strengthen our unique profile of being a profitable self-funding. Biotech company with an Innovative Catalyst, Rich pipeline poised to deliver meaningful value.

For patients providers and shareholders alike.

We believe that this is what makes Harmony 1 of the most compelling growth stories in biotech today.

Thank you. And I will now turn the call back over to the operator for Q&A. Operator.

Thank you.

Please press star 1 on your telephone keypad, if you wish to remove yourself from the queue, you may do so by pressing star 2, we remind you to please pick up your handset and please limit yourself to 1 question and 1. Follow-up question. And we will take our first question from Amy fadia with nem. Please go ahead.

On uh the strong code quarter. Uh my first question is just around kind of your guidance. Um

You obviously raised your guidance. And, you know, even if we look at the year to date performance, compared to the full year 2024, this certainly, um, acceleration in the new patient ads, uh, this year

so, if, if you could sort of elaborate on, um,

How you see the trajectory of Vex evolving? Uh, it's certainly several years into the launch but uh, it it appears that there is acceleration here. So uh, if you could comment on how you see that evolving into 2026 and if that can be sustained,

Uh, and then I have 1 or 2 other questions. Thank you.

Jeffrey Dayno: Yeah. Thank you, Ash. Let me start with the first question about our pipeline. I just want to reiterate that I continue to have strong conviction in our pipeline programs, Kumar's leadership, and our R&D organization, which has a lot of experience and expertise. We don't have time, but if you look at each of, if you look at the IH study, if you look at Fragile X, there are good reasons in terms of the outcomes that we've sort of talked about. In the ZYN002 program, in talking with KOLs, unfortunately, that pattern—programs where there were positive phase two data and a lot of expectation because there are no approved treatments, and a high placebo response rate—kind of got into multiple phase three programs, which is the reason why none have been successful.

Okay, good morning, Amy. Thank you for your question. Um, I'm going to turn over to um, to Adam to speak about in terms of the trajectory of patient ads and, you know, this strong fundamentals there and then some deep can comment on kind of our thoughts and position and guidance. Um, Adam, yeah, thanks Jeff and good morning Army. Uh, thanks for the question. So yeah, performance is going to be driven fundamentally by uh patient ads. And as you saw we we're extremely pleased with the quarterly increase in average patients of 500. We haven't seen that high of an increase uh ever uh since launch. And it comes on the back of uh a solid Q2 increase of 400 patients, which we had only seen twice previously. In the last time we saw an increase of 400 patients was I think early in 2022. So we're very pleased with the with the underlying performance.

Of the brand and the fundamentals remain strong and that momentum, uh, we expect to carry forward into Q4. But, uh, Sandy just want to mention sure on your.com. Yeah, no, absolutely. Um, as mentioned on the call, I mean, we recently raised our guidance from 820 860 million to 845 865 million, you know, um, as

The year we had originally guided to about 8,000 patients and we're well ahead of that as well by urine. So, really, we're going to see great momentum, going into the end of the year on Topline demand, and and certainly going into

2020, 2026. And of course, you know we're rapidly approaching Blockbuster status for WAY TOO. Yeah. Yeah. I mean, I would just add that I think, you know, obviously we're very pleased with the recent trends and...

And we're following them, you know, in in terms of, um, you know, how that will, you know, assisting us going into the future. But, um, underlying fundamentals remain very strong. Pleased with obviously some of the things Adam has done with the commercial team and um you know and and that positions as well going forward.

Great. Thank you. And my next question was just for Kumar um, with regards to the gr formulation. Um, can you uh give us some color on what were the GI AES um seen with the GS foundation and how, you know, did the grade of frequency of those AES compared to the in-market, you know, reyax sort of titration in the initial dosing period?

Yeah. Hey, good morning gummy. Uh, thanks for the question. Uh, what we are disclosing right now is, uh, no new safety or tolerability, issues or observed with the polls and gr formulation, no serious AES were absurd. Uh, the safety and tolerability was in general consistent with the established safety tolerability profile of pitos and gr, uh, we will be disclosing the full data set, uh, in upcoming meetings, having decided when exactly but what's important from the pitos and gr formulation Army is we initiated 46 patients with narcolepsy, with PTO and TR at 78, uh, 17.8 milligrams and all of those patients.

We were successfully able to tolerate 17.8 G.

And about 98% of the patient who went to get 35.6 mg of the 1 week of PTO authenticity.

We?

asked 98% of them were able to tolerate dollars in gr 35.6, and this is an important differentiation because if you look at, uh, the medicines that are approved for patients with narcolepsy,

Every 1 of them including petals and has some level of titration and getting rid of the titration, will have the patience to start at the therapeutic dose range, uh, potentially can experience efficacy earlier, potentially less number of dropouts, and potentially better overall patient experience.

Got it. Um,

to, uh, if I could just squeeze in 1 more other quick question, if you could just elaborate on

Uh, some of the details of what we should expect from the August, uh, open label extension data at AES in December.

Thanks.

Yeah. Uh, thank you Army. Uh, yes. We do. We, we will be presenting, uh, some efficacy data on epx 100 from the August open, label, extension study. And we'll also be presenting safety and tolerability data from epx 100 from the same study, August double, blind, randomized study, and also the open label extension study. Uh you'll see the overall efficacy.

The safety tolerability offers a overall very unique benefit risk profile for patients with Developmental and epileptic. And this particular instance, particularly the data that we'll be sharing is uh in patients with the dwai syndrome.

Okay.

Thank you, great. Thank you Amy. Thank you. Thanks.

Thank you, and we will take our next question from David Anselm with Piper Sandler. Please go ahead.

Um, thanks just a couple for me. Uh, first wanted to get your latest thoughts on bizdev and m&a. Uh particularly in light of the failure of zygel, are you thinking um, more expansively uh regarding um Acquisitions, are you open to more of a uh a sizable transaction, perhaps a market ready or commercial stage asset, just trying to get a sense philosophically for where your heads are at. That's number 1 and the number 2 looking a bit longer term regarding uh way kicks uh with the introduction of the first direct and Agonist um Coming potentially before the end of

Um, how are you thinking about the trajectory of Wix Beyond 26, specifically. Uh, in 27 with over per Exxon, um, potentially in the market. Thanks?

Yeah, good morning, David. Thanks your um, your questions. So first with regards to to bizdev and our

You know, sort of thinking there, um, I mean it really hasn't changed. We, you know, we have always been

focused on Business Development being strategic, uh, thoughtful and you know how we deploy our Capital, you know, as we have build out our pipeline, you know, obviously there's an IRB acquisition and then and then epigenetics, uh, I think at this point, um, despite the fragile X data readout, it doesn't really change our strategy. We have a dedicated BD team, you know, for focused on sort of search and evaluation. Um, and, and at this point, um, it really is our intent with our strong balance sheet. Um, to pursue, you know, Innovative assets to build out our pipeline to grow our product portfolio. Um, we are actively, you know, evaluating several, um, and you know that is our plan, but the strategy Remains the Same, our focus in orphan, rare CNS disorders, um, to be strategic, you know, within the current franchises

Uh, but also looking at adjacencies potentially in broader neuro indications, um, where we could, you know, utilize The Proven commercial engine, um, so the strategy Remains the Same. Um, I think, um, a bit more focused, you know, with regards to our intent, um, to move forward with business development. Um, you know, when we find the right opportunities for us,

And, um, in terms of Adam, in terms of thoughts on like its performance in, in the setting of emergent erections Adam. Yeah, thanks Jeff. And thanks for the question, David. Um, look. We're excited about, uh,

Our Excellence. Um, obviously because we have 1 of our own, but obviously it's also an important uh, potential new treatment option for patients, and we remain confident in our ability to grow and perform with weight gains, well, into the future and there's a couple of reasons for that. Um, the first is just the approach to therapy in. In this market, the Hallmark of of treatment is poly Pharmacy. Uh, you have the, a high majority of patients that are on 2 or more therapies and that will continue. We recently verified that into market research that we've done speaking with Physicians and they expect that to continue as well.

Um, but also, if you just look at the history of wake, at quake's performance has been extremely steady regardless of new entrance, whether it's brands or generics, um, and we would expect that to continue as well. In fact, if you look at kind of the the narcolepsy Market in in total, anytime there's been a new brand entering, it tends to expand brand utilization.

Um, and uh, and we would expect a similar Phenomenon with with an orexin launch, uh, when those come to Market, uh, but we're also highly confident, just because of Wix is a highly differentiated product. The only non scheduled treatment option, Physicians will have had 7 8 plus years, of clinical experience by the time of erections launch and it, it holds a unique position in the minds of healthcare providers. Um, they're highly familiar with it, uh, provides, uh, strong efficacy and is, uh, and they believe it's very well tolerated. So it can be added, uh, to combinations of therapies across a very broad selection of narcolepsy, patients, uh, and that will continue as well. It will continue to hold that position. So for those reasons, I think we're very confident in our our continued growth and performance, well, into the future,

Okay, thank you.

Thanks David.

Thank you and we will take our next question from Greg. Savinovich. With M Zhou. Please go ahead. Your line is open.

Hey good morning, thanks for uh taking my question and congrats on the progress. Uh 1 question for me, just going back to the 2025 guidance.

Um, it was nice to see a raising of the guidance, but if you do the math, it does imply fourth quarter sales for wake. Wake kicks in the range of I think 221 to 241 and uh, on a quarter to quarter basis, that's essentially flattered down uh, on a quarter, a quarter basis. So can you just provide more color and how we should be thinking about whether it's that patient ads or gross to net or seasonality when trying to model fourth quarter? I know you, uh, Sandy had mentioned, some inventory, um, could be a factor but any other color would be great on a fourth quarter, especially given the great momentum on that patient ads.

Growth that we expect to continue, uh, as we go from Q3 to Q4 as well. I think, uh, we did as a, as I mentioned, we did see a few days of trade, inventory, increase in Q3 which impacted, uh, the the sales positively just as, uh, as I mentioned in Q2, it was quite the, the other way. The other direction, you know, right now. I mean we feel very good about the the range that we put out there, you know, we recently raised it as you mentioned, you know, this gives us great confidence, you know, as as and I'm sure like like every, uh, Team, I mean, we'll do everything we can to certainly, you know, not only meet but potentially but exceed the the range as well.

Again, uh, it's hard to predict again Q4, um, because there are typical variabilities, uh, as you come to Q4, especially around, Brandon holidays. So forth. So again, we feel good about where it is. It's very robust growth year-over-year. It's going to be a robust growth over prior year. Um, and and we see again weight gains very quickly approaching Blockbuster status. Um you know, as we go into 26 and Beyond.

Great. If I can ask a follow-up, just your, your net cash uh, position is building quite nicely. Um,

I'm sure, uh, there are various views and how to deploy that cash. Uh, wondering if, uh, maybe, um, in a, in an answer that might be slightly different from David's question on, BD. Um, what are your kind of current thoughts? Um, on how best to deploy that, um, nicely uh, our crew in cash balance?

Yeah sure. I mean, look, we um, as as as Jeff mentioned, I mean we continue to look for business development opportunities. I think we've got something that's been a strategy for us for many years now. And, and we see attractive opportunities out there, uh, that that, uh, we could, uh, potentially transact. And, you know, we have again a continued growth in terms of cash. Uh, you know, we had very strong cash generation last quarter of 100, you know, 6 million dollars, um, 778 million at the end of the quarter, uh, you know, and I think that gives us increasing confidence that, you know, we we but again, we're going to be, I would say, uh, thoughtful in terms of how we deploy our capital. I think, we certainly have multiple ways in which to drive, uh, value for shareholders, certainly more recently, we've been prioritizing business development, but in the past we've also done share buyback as well as an opportunity. And again, at the right time, you know, we'll look at, uh, various opportunities to drive value for shareholders.

Yeah. Okay, thank you. Oh great, I'll just go ahead.

No, no. I I appreciate the question. I I just want to um reiterate I think, you know, while you know, 1 can never predict, you know, the timing in terms of Business Development and transactions, um, as Sandy, but alluded to um you know, we have optionality

But our focus and our intent, um, is really to pursue, you know, Innovative value-enhancing assets. We want to build our pipeline,

We see that's where the value is going forward as well as um build a broader product portfolio. Um in terms of we have a strong commercial engine, we want to continue to utilize that with additional products. Um so you know that is our intent and we have a strong balance sheet uh to execute on that.

Thank you.

Thanks.

Thank you, and we will take our next question from Jay. Olsson with Oppenheimer? Please go ahead.

Oh, hey. Congrats on the quarter and thank you for taking the question.

Can you talk about your life cycle management plan for pollus and gr and HD with regards to new patients and then which patients currently on Wake. Kicks are the best candidates to benefit from gr and HD.

and then for your erection 2 program,

What would you like to learn from your Phase 1 study and any lessons learned from the Alchemies and Picada data at World Sleep? Thank you.

Consider as well. So for GR, it's really around new wake.

Ex patients and previous patients.

Uh, and then where the HD comes in.

Uh, with a with a greatly differentiated profile. Uh, we would see the strategy there, focusing on not only new wake patients and previous patients, but also existing Wix patients. And that's where the, the transition potential comes in and we've we've uh conducted market research around this hp's respond, very favorably to the profile of HD. They view it as clinically uh significantly uh differentiated

Um, actually Superior and uh, in market research, they tell us they would consider transitioning a majority of their patients that maybe aren't uh, better but not well. Uh and so that's the strategy with HD.

Uh, and then both, uh, formulations have utility patents filed through 2044. So it it really allows us to expand and extend our sleep wake franchise, uh well into the future.

Thank you.

Jeffrey Dayno: We have learnings from that, and we will take those learnings going forward. I think I continue to have conviction in EPX100, our other pipeline programs. Kumar, any additional thoughts?

Um in terms of our Corrections today on this program learning from some of the other development programs. Sure. Thank you Jeff. Yeah. Good morning J and uh thank you for the question. Uh yes. We are on track to initiate the phase 1 study with our products and to receptor Agonist this quarter.

As we have discussed in the past, we will be starting a healthy volunteer single ascending dose study and in parallel, we will be conducting a sleep deprived healthy volunteer study as well to bracket the door. Uh, a bit and we are closely watching the data that came out of world sleep Congress uh from other for instance Dr. Icon is especially as it relates to dosing and the safety and tolerability profile alongside the efficacy. You know we have 1 of the most important oriented receptor Agonist based on all the publicly available data and it lends itself to Target the central distance and on N2 and DD Pacific hypersomnia at very low dose providing us the dosing flexibility to Target these 3 indications and we are also trying to see how we can accelerate our own program based on the data that is coming out from the other Forex and the center of Agonist and you

Will be hearing, uh, more from our own RX Interceptor Agonist, when we initiate the first inhuman study, and we also anticipate to share some of the clinical data in 2026. Thank you, sir.

Super helpful. Thanks again, and congrats on the quarter.

Pete Stavropoulos with Cantor Fitzgerald, please go ahead

Uh, good morning and congratulations on the progress and thank you for taking my question. Um, could you just touch on uh, epx 100 Epps program? You know, any clinical data that has been generated and disclosed that sort of gives you a confidence in the duvet and LGS program, you know, any details on efficacy durability and safety and, uh, can you also give us a sense of how enrollment is going in the phase 3 studies? Um, any granularity on timing of data, or when you expect to complete enrollment,

Thanks.

Uh good morning Pete. Thanks for your questions. Um I'll turn to Kumar for some more color on epx program. Yeah good morning Pete and thank you for the question. Uh yes. I mean we are excited to share some of the efficacy data at the upcoming uh American epilepsy society meeting.

In December. Uh, as I mentioned earlier in the call, we will be sharing the data from the August open label extension study. That the study in do intro.

Uh, in terms of your question around, uh, Recruitment and enrollment. Yes, I mean we continue to recruit patients.

In both August study and the lighthouse study that's true and LGS studies. And we anticipate to share Topline data in 2026, uh, we'll be providing more Glam granularity in terms of timelines as we progress, uh, with the enrollment

Thank you.

and uh, any thoughts on taking a 100 and other Dees or other DS Remain the focus of uh, 200

Adam Zaeske: Yeah, I think you covered it.

And try to get to the Topline data as soon as possible and try and help this patients with a product profile, uh, which is very favorable, not just for man, efficacy perspective but also, uh, from a safety and tolerability perspective.

Adam Zaeske: Thank you.

Thank you. Yeah and Pete maybe 1 1 1 Edition just to to remind everyone. So epx 100 Clements all hydrochloride. So um a first generation antihistamine you know that that was in the market for about 20 years with a proven safety, tolerability profile and in the overall sort of, you know, risk benefit in, in these, um, sort of therapeutic options, uh, with other, you know. Um,

Jeffrey Dayno: Okay.

Indicated agents such such as at the dialects. Um, and the need to monitor lfts or fintepla. Um, with the echo cardiogram is required in the Rams program because of cardiac value or disease the risk there. So, you know, there is sort of a proven safety tolerability profile. And in the overall kind of risk benefit, um you know, we see the opportunity there as we go forward and generate efficacy data in both your day and and LGs.

Adam Zaeske: Yeah, thanks, Ash, for the question around achieving a billion in revenue. Obviously, it's a little bit premature to provide guidance for 2026 specifically, but we're seeing very strong momentum, as you saw in Q3 and in Q2. We'd expect that momentum to continue in Q4 and well into 2026, and we're confident we will achieve a billion in revenue well before LOE. Confidence remains high.

All right. Thank you very much and congratulations once again.

Thank you, and we will take our next question from Danielle bril with truist Securities. Please go ahead.

Hi, guys. Good morning. Uh, congrats on the quarter, and thanks for the question. Um, maybe just 2 quick ones from me. Do you have any sense of What proportion of your 8100? Patient base is nt1 versus nt2? And then what findings, if any, in the fragile X data set, would make you consider reactivating the q22 trial thank you.

Morning Danielle, thanks for your questions. Um, Adam breakdown is on patience on sure. Thanks for the question. Uh, it's been very consistent actually for the last several years. We see about 45% of patients,

uh, from nt1 55% from nt2 and that's been uh, very stable

Okay. Uh, 2 more. Yeah, uh, Daniel, good morning and thank you for the question. Uh, we are right now conducting you in depth review of all the data from the reconnect study, uh, as mentioned, uh, previously, uh, the flex syndrome study did not read out as expected.

Update mainly because of the larger than anticipated possible response right now we are conducting a number of post talk analysis. Uh it's very hard to say at this point in time what kind of data sets we need to see before we Embark upon, 22q deletion syndrome, phase 3 study. Once all these data sets are available, we will make a decision based on the data that we see and, uh, we should be able to complete this work by the end of this year, and we should be able to provide some updates on, uh, the flex syndrome study itself and also the implications on 22, relations syndrome, early next year.

Thank you, Daniel.

Thank you.

Thanks Danielle.

Thank you and we will take our next question from Karen Johnson. With Goldman Sachs. Please go ahead.

Hi. Uh this is anupam on behalf of Corin. Uh maybe 1 question for Kumar, can you talk about the uh effect size you are powering for the phase 3 pit and HD study to show on ESS scale and what do you think are clinically meaningful difference? Would be in comparison to the current wakes in order to support the HD. Use? I think the WX shown around 12 to 13 Point final years score, any color on that.

Hey, uh, good morning. Uh, thank you for the call, thank you for the question. It's an enhanced formulation. It's an enhanced NextG formulation; it's not just the hydro.

But it's also it also has an optimized uh PK profile.

Based on the dose response that we have seen with pedals in the pivotal narcolepsy clinical trials. And also the studies that we conducted in probability syndromes and also in myotonic distroy, uh, and they do expert and the exposure response data, some of the exposure response data that we have, we anticipate a meaningful increase in the efficacy from an excessive data and sleepiness perspective.

But it's also important to note that we are not just targeting excess data and sleepiness. We are also targeting fatigue in patients with narcolepsy, for which there are no approved treatments. Additionally, we are targeting sleep inertia in patients with idiopathic hypersomnia.

And we plan to accomplish all of this without compromising on the safety or tolerability profile of PTO Ascent. In fact we conducted a phase 1 P study where we studied we don't spend up to 180 mg which is up to 5 times. The maximum label dose of vehicle and the safety and tolerability profile in general for similar to what we see with the vehicles. So what it means at the end of the day is a very unique benefit is can all of us?

With the established safety profile established tolerability profile larger efficacy. Next day time targeting symptoms like fatigue and narcolepsy targeting symptoms like sleep inertia and patients with idiopathic hypersomnia all while maintaining the non-scheduled status and a very simple dosing regimen of taking

Here in the morning. So that's what we plan to accomplish with PTO and density.

Okay, thank you.

Thank you, and we will take our next question from Patrick shio with HC Wayne Wright. Please go ahead.

Thanks, good morning. I was um, wondering if you could elaborate a bit more on the um, you know, sustainability and as well, the drivers of that record. Approximate 500 patient, add in the third quarter and if we should expect those you know those drivers to continue in the fourth quarter. But as well in 2026

And then separately on the tools and HD. I think you mentioned you know strong early feedback from Physicians and payers. I'm wondering if you collaborate on what's resonating most and as well the implications for the phase 3 development program.

Yeah, good morning, Patrick, thank you for your questions. Um, Adam.

Yeah, thank you for the question. So we're really pleased with the momentum. We're seeing increases in in patient ads as you mentioned. Uh, and the drivers.

Look at, I think it's starts with, uh, Wix is a highly differentiated product. It's the only non-scheduled treatment option, um, and that is combined with strong execution, across the organization. So, um, you know, if you think about sales, Effectiveness and execution,

Marketing and promotional excellence, payer coverage, patient support. We've made adjustments in all of these areas.

Uh, and we're seeing those adjustments.

Uh delivering the performance that you're seeing and and uh and have confidence that that momentum will definitely carry forward in in Q4 and and into 2026.

Okay. And, um,

Jeffrey Dayno: Thanks, Adam. Thanks, Ash.

Patrick your second question. Yeah. So around the HD and so what resonates um, what resonates is uh, the promise of improved efficacy. Um, the the no titration starting at at a therapeutic dose and unique indications, especially around IH, and fatigue. We know that, you know, 60% of narcolepsy, patients present with fatigue. This would be the only product that has the indication for fatigue in narcolepsy.

Um, and they view that as highly differentiated. So, uh, I mentioned the feedback from hcps but we've also done research with payers, um, and the response is that we would expect broad payer coverage, uh, for the HD product, uh, with minimal step edits through, uh, for Wake kicks or no step edits actually, prior to LOE. And even after LOE, uh, only some mentions of perhaps some step edits, but only for patients that have never had any experience on wix

Before, uh, which at this point. Um, you know, and I guess we'll be at what 8 plus years in the market by then, uh, the vast majority of patients will have had some experience with wake exit, uh, at some point in the past. Um, and then, of course, any patient that presents with fatigue would also not be subject to any step edits, uh, through Wix even post Eloise. So we would expect broad payer coverage pre and post Halloween supporting the product and, uh, and its uptake.

Operator: Thank you. We will take our next question from David Huang with Deutsche Bank. Please go ahead.

Thank you, and we will take our next question from Jason Gerber with Bank of America. Please go ahead.

Hey guys, this is thin uh on for Jason, just 2 questions from us. The first design epx. 100 you have 2 phase 3 readouts, expected in 2026. So maybe if you can just speak to what you've learned from the fragile X syndrome as well as the prior idiopathic hypersomnia study about managing Placebo response in these types of neuro developmental studies. And then the second question is on weeks. Can you just speak to where new patient growth is coming from? Are you activating new prescribers or is the growth primarily from deeper penetration within existing writers? Thank you.

The epx 100. I mean, as you know, what we are studying here is the seizure frequency, uh, which is, uh, slightly different from what we studied, uh, with uh uh, z102 in the flex syndrome, a possible response. Uh, in general is part and parcel of all neurosight trials, especially psych trials with behavioral endpoints, uh, like Flex syndrome.

And uh, we have multiple checks and balances uh, within the study to manage the plus support response.

Uh, with epx 100, uh, it's slightly different in the sand. Uh, seizure frequency uh is uh uh, much more observable.

And much more definitive compared to some of the behavioral symptoms. So, these are 2, distinct indications, uh, with the distinct, uh, end points. Uh, but your point, uh, in general. Uh, yes, let me proceed for response. Can happen in any clinical trials, and that's something that we are watching. And we have checks and balances with with our epx, 100, organs, and Lighthouse, clinical trials, as well.

Okay um Adam yeah and then in terms of wake uh new patients. So the short answer to your question is we see uh both new patients from increased penetration of existing writers as well as the addition of new writers.

Sandip Kapadia: Hi there. Thanks for taking the question. I want to ask on eligible patients for Wakix, or sorry, pitolisant HD and GR. I think for HD, you mentioned new, previous, and switch patients, I think, are all on the table. Just wondering what, in your mind, defines a good switch patient for going from Wakix to HD, and then would switching be an option for GR patients? Thanks.

Uh, we see quarter over quarter, pretty steady increase in new writers, um, every quarter. Uh, and that's, that's, uh, continued for the past several years. We would expect that to continue, um, a little bit more detail, you know? Remember, we, we call on actually, more than 9,000 positions. And that's, that's 4,000 that are enrolled in the oxybate, Rems programs, but also more than 5,000 that are not enrolled in oxybate rims, uh, programs we have the ability to call them, both of those sets positions, and in both instances, we see increased penetration as well as, uh, new writers.

Would you say, you know?

Yeah, um, no, thank you for your question. I just to add

You know, at at a higher level just to remind everyone that, you know, this is a large, this is a large market. So in in terms of the continued growth of Wix, a highly differentiated product profile with broad clinical utility. Um, the only non-scheduled product which is Meaningful, um, that, you know, as a former neurologist, treating patients, you know, very meaningful in terms of therapeutic options, but in in a sizable Market, 80,000 patients diagnosed. So as this Market evolves and grows and more,

Understanding, um, similar with, you know, the, the learning about fatigue as a prominent symptom in patients, with narcolepsy about 60%, so designing that into the solution HD program. Um, so I think that is the backdrop, why we are confident, why, um, you know, the underlying fundamentals and the growth of Wix, um, in narcolepsy. Um, and our excitement and confidence in the tools and HD program, and tools and gr. Um, I think, you know, that that has a lot to do with it as well. Yeah, I think it's, it's a great Point, Jeff. I mean, the fact that we're at 8100 average patients. Now in a market of over 80,000 diagnosed patients, obviously, we have a lot of, uh, room to continue to grow. Yeah. And, and also in a poly pharmacy market. I think, as we are all familiar with where any chronic neurologic disorders, it's rare that a single mechanism of action.

Will be able to treat.

Difficult to treat chronic symptoms. And um, I think this is this is what we're seeing as wages continues to grow.

Thank you.

Thank you. And we will take our next question. From Ash, Verma with UBS. Please go ahead.

Oh, hi. Uh, yeah, thanks for taking, uh, questions from us. Uh, so maybe just, uh, I wanted to get your latest thoughts on how you're thinking about the overall Pippin and diversification, I mean we've seen 2 different setbacks recently person in the I8 side and then on Friday, Alex, uh, what gives you the confidence that the subsequent pipeline programs, have higher chances of success. Uh and then on the vics, uh, 1 billion dollar guide uh is that something uh that you can achieve in 2026 just at the pace uh at which you're going and where 42 is analyzing at uh with the cers or X and expected to launch in um 2027 what's your level of urgency to hit the long-term guide before the competitor entry? Thanks.

Kumar's leadership and our R&D organization, which has a lot of experience and expertise.

Uh you know, we don't have time. But if you look at each of, if you look at the IH study, if you look at fragile X. Um, you know, there are good reasons in terms of the outcomes. Um, you know that we've sort of talked about um, in in the zyn 002 program in talking, you know, with kols on unfortunately that pattern, um, you know, programs where there were positive things to data and a lot of expectations because there are no approved treatments and a high Placebo response rate, you know kind of got into multiple phase 3 programs which is the reason why, you know, none have been successful we have learnings from that and we will take those learnings go and forward um but I think I continue to have conviction. You know in epx 100 or other pipeline programs and Kumar any additional thoughts. Yeah I think you got it. Thank you.

Yeah, and then uh, thanks Ash for the question around uh, achieving a billion in in Revenue, you know, obviously, it's a little bit premature to provide guidance for 2026 specifically but um, but we're seeing very strong momentum as you saw in Q3. And then Q2 uh, we'd expect that momentum to continue in Q4 and well into 2026. Um, and we're confident, we will achieve a billion in Revenue. Well before eloe, so um,

Yeah, confidence remains High.

Thanks Adam. Thanks Ash.

Thank you, and we will take our next question from David Juan with Deutsche Bank. Please go ahead.

Hi there. Uh, thanks for taking the questions. Um, so I I I want to ask on eligible patients for, uh, weight gain or sorry, the tolla Cent HD and CR. I think for HD you mentioned, uh, new previous and switch patients. I think are are all on the table. Just just wondering what, uh, in your mind defines. Um, a good switch patient for going from weight kicks to HD and then is switching with switching being option for GR patience. Thanks.

Thanks for the question. Um,

So, I guess the, you know, the switch patients, obviously that's going to be determined by the health care provider. But we know that 75% of patients with narcolepsy continue to struggle with residual symptoms. Uh, and so if we're, you know, if we're able to offer the HD product with an improved efficacy profile, but the same safety and tolerability profile that they're very familiar with on Wix, uh, we would expect HCPs to consider their patients who potentially could, uh, benefit from a boost in efficacy. Uh, and feel confident that, uh, they won't be addressing or introducing any new safety or tolerability issues.

Um, and also any patients that present with fatigue. And as I mentioned before, we know that 60% of patients with narcolepsy, do present with fatigue. Those would be prime candidates uh uh for the HD as well. And then for the gr. Yes. I mean a switch would be an option certainly for the healthcare provider. Uh in terms of our strategy, we'll be focused on new patients in previous patients. As I mentioned before.

Thank you. And I'm showing no further questions. I would now like to turn the call back for any closing remarks.

Thanks operator. Um, on behalf of the harmony team, I want to thank everyone for joining our call today and for your interest in harmony biosciences, uh, have a great rest of your day.

This does conclude today's Harmony bioscience Sciences third quarter, 2025 Financial results conference call. You may now disconnect your line and have a wonderful day.

Adam Zaeske: Thanks for the question. I guess the switch patients, obviously, that's going to be determined by the healthcare provider, but we know that 75% of patients with narcolepsy continue to struggle with residual symptoms. If we're able to offer the HD product with an improved efficacy profile, but the same safety and tolerability profile that they're very familiar with on Wakix, we would expect HCPs to consider their patients that potentially could benefit from a boost in efficacy and feel confident that they won't be introducing any new safety or tolerability issues. Also, any patients that present with fatigue, and as I mentioned before, we know that 60% of patients with narcolepsy do present with fatigue, those would be prime candidates for the HD as well. For the GR, yes, I mean, a switch would be an option, certainly, for the healthcare provider.

Adam Zaeske: In terms of our strategy, we'll be focused on new patients and previous patients, as I mentioned before.

Operator: Thank you.

Jeffrey Dayno: Thank you.

Operator: I'm showing no further questions. I would now like to turn the call back for any closing remarks.

Jeffrey Dayno: Thanks, operator. On behalf of the Harmony team, I want to thank everyone for joining our call today and for your interest in Harmony Biosciences. Have a great rest of your day. Thank you.

Operator: This does conclude today's Harmony Biosciences third-quarter 2025 financial results conference call. You may now disconnect your line and have a good one.