Hello everyone, thanks for joining our next session with Harmony Biosciences. Again, I'm Ami Fadia, a biotech analyst here at Needham. It's my pleasure to be hosting the company here; we've got the full team, so thank you everybody for taking the time to join us today. I just wanted to remind our listeners that we have the dashboard as an avenue for you to send any questions that you'd like me to ask the team. But let me have Jeff Dayno, President and CEO of the company, kick us off with a quick overview of the company, and then we'll dive straight into questions.
Thank you, Ami. Good morning everyone, and Ami, on behalf of the Harmony team, thank you again for the invitation to sit down and speak with you about, you know, some of the exciting things happening at Harmony. I think just at high level, you know, Harmony continues to be a growth story, as we've said all along, especially, you know, starting with our foundational business, you know, commercial business, WAKIX, you know, in narcolepsy. As you'll probably hear, you know, there's plenty of room for growth going forward there. Then turning to, you know, our pipeline programs and the advancement of our pipeline programs with, you know, multiple catalysts coming, you know, sort of within the first half of this year. You know, Ami, we're excited, our pediatric narcolepsy submission and the priority review with a PDUFA date, you know, coming June 21st.
What's important about that also is that's one of two data sets that we're working towards to obtain pediatric exclusivity, the important additional six months on the back end of the longest patents. The other data set for pediatric exclusivity, we've kicked off that in our Prader-Willi phase III TEMPO study that we, you know, recently announced initiation of that. So it's not just for an indication in Prader-Willi syndrome, but that's the second data set, as we've discussed with the agency, required for pediatric exclusivity. So with those two advancements, we're, you know, sort of well on our way to, you know, the additional six months of pediatric exclusivity. You know, turning to idiopathic hypersomnia, or IH, I think, you know, a topic of great interest.
We had a meeting with the FDA last month, and as we said, you know, we're waiting for the final meeting minutes. And then on our next earnings call, we'll be providing an update with regards to the path forward, in IH. And then, the new formulations, the next-gen formulations of pitolisant, you know, NG1 and NG2 that we've talked about, and we are on track with sharing the topline pilot PK data, you know, the first half of this year. So a lot of exciting things coming up with regards to, you know, our development programs. And Ami, I also wanna mention, ZYN002 from the Zynerba acquisition. So Kumar and the team are kind of on top of that, the phase III RECONNECT study.
We're very excited about that opportunity, you know, as we've shared, you know, on track for completing the trial first quarter next year with topline data in mid-2025. Then lastly, we continue to be very active in business development, looking at a lot of interesting opportunities. One can never sort of predict when those things happen, but we remain very focused and active. The goal is to expand, you know, our pipeline, diversify our portfolio to drive long-term growth. So we are really excited for what's coming in the next several months at Harmony, along with continued growth of our foundational business of WAKIX and narcolepsy.
Great. Thanks, Jeff, for that overview. Yes, sounds like we've got a lot to look forward to in terms of learning about the update on IH and the new formulation data. But let's start with the foundational product. You know, you talked about the continued sort of potential for growth. You launched this product in the narcolepsy market a couple of years ago, and you've been able to expand the patient population that gets treated with one of these sort of more recently approved branded products, beyond, you know, stimulants and such. Can you kind of talk about where you are with that, sort of accessing that potential, and maybe kind of give us a sense of, you know, how many patients you have on the product now, as opposed to how many, you know, what's kind of that target market size looks like?
Yeah. Let me just start off, and I'll turn it over, obviously, to Jeff Dierks, our Chief Commercial Officer, who you know, knows the details well. But I think it starts with, you know, WAKIX is truly it has a differentiated, you know, product profile. And I think, Ami, you're familiar with this. The overall benefit-risk proposition, you know, is the only non-scheduled, you know, approved treatment option, narcolepsy. And that translates into its sort of broad clinical utility and our broad prescriber base, you know, and in that, you know, some that are in the oxybate REMS programs and others that don't participate in that. So I'll turn it over to Jeff, I think, to you know, give you some more specifics as you know, why we see where the growth is coming from and the opportunity ahead.
Sure. Thanks, Jeff. And, thank you again, Ami. So I mean, obviously, the narcolepsy market is a very unique market. Although it's a rare condition, you've got about 170,000 individuals thought to be living with narcolepsy and a very large diagnosed patient opportunity of about 80,000 individuals. You have a market that's polypharmacy in nature, right? It's a non-curative disorder where most patients are on multiple medications. And as Jeff shared, we've had an extremely successful launch in the last few years. We exited 2023 with approximately 6,150 average patients on the product, and we've been able to demonstrate durable growth. We've grown average number of patients and the number of unique prescribers of WAKIX every single quarter since our launch.
And I think to go back to what Jeff shared, WAKIX just really provides a very unique and differentiated and meaningfully differentiated product profile that aligns really well to the unmet needs in the market. You've got a, you know, the first and only non-scheduled treatment option approved for both EDS and cataplexy. Well-tolerated side effect profile can be used with other medicines, which really kind of works well on a polypharmacy market. It's a once-daily oral tablet you take in the morning upon wakening. And as Jeff shared, WAKIX really offers broad clinical utility and appeals to a broader prescriber base. There are about 9,000 healthcare professionals in this market that see and treat about 100% of the diagnosed patient opportunity. About 4,000 of them are enrolled in the oxybate REMS program, and we've seen great uptake, high penetration in that audience.
But there are about another 5,000 healthcare professionals that aren't in the oxybate REMS program. They don't tend to write scheduled medicines. And we've seen great uptake in this audience. We reported about being a little more than 30% penetrated at the end of last year. We continue to see good uptake, and we'll provide an update at our next earnings call about where we are with that audience. But our ability to tap into that broad prescriber audience allows us to tap into the entire diagnosed patient opportunity, insulates the brand a little bit from the oxybate churn that we've been seeing in the last couple of years with generics, once-nightly low sodium, and it gives us a ton of confidence that we're gonna continue to see growth and WAKIX being a potential billion-dollar opportunity alone in narcolepsy.
Obviously, with the guidance that we've shared for 2024, we're well on our way.
That's a good segue into my question about the guidance. You got it to $700 -$720 million in sales for 2024. What are some of the variables that sort of go into that guidance? And you can sort of talk about the, you know, your confidence level in achieving and perhaps potentially even beating that guidance? This was the first year you provided, you know, a full-year guidance as well. So maybe kind of talk about some of the thought process behind that.
Sure. Maybe, maybe I can comment, and maybe Jeffrey Dierks, you can comment further on it. You know, I would say, Ami, why we had a great 2023. As you know, we had 33% sales growth. We had good momentum coming out of coming out of the year. This was, like you said, our first year of guidance. So, you know, our guidance range of $700 million-$720 million, I think, represents a good, thoughtful, and balanced approach, especially in the first year. You know, the guidance, I think, also highlights what we've been saying for many years now, that we're well on our way to $1 billion-plus in adult narcolepsy alone. And that's been pretty consistent, all along. And we're confident in that. And we certainly see opportunities. You know, I think we'll certainly provide updates as, as the year progresses, there.
Maybe, Jeff, you wanna comment a little bit on the pushes and pulls, you know, and, and how you see sort of like the phasing for the year?
Sure. Well, Ami, obviously, the guidance is gonna take into an account for the typical seasonality that we see, the, you know, the headwinds and the tailwinds that we in the industry face every year. You know, we're in Q1 and just completed that, and we'll be talking about it at our Q1 earnings calls. But the typical seasonal payer dynamics that you get in the first quarter, you've got prescription reauthorizations, the higher copay in Medicare out-of-pocket, support for manufacturers. And it's important coming into 2024, we were bringing forward about 6,150 average number of patients, whereas in 2023, we only had about approximately 4,900 patients.
So there's a larger number of our patients that are exposed to the reauthorizations, that happened for most specialty and branded products in the first quarter of 2024. And additionally, you know, we sort of had a new external variable, and the industry as a whole is seeing an additional headwind with Change Healthcare, which has really caused it, you know, a challenge and made it harder for doctors and pharmacies to fill prescriptions, submit insurance claims, and receive payments. So we feel like we've managed that pretty well, but we've had some additional headwinds in the first quarter, that we're, you know, working through. In addition to the Q1 dynamics that we see, we're expecting the traditional Q3 seasonal payer headwinds. You have less patient visits during the summer months and vacations is, you know, traditional for all chronically managed medicines.
We're anticipating tailwinds in the Q2 and Q4, which tend to be stronger prescription months, you know, we're gonna continue to tap into that large remaining diagnosed patient opportunity as the market allows around these dynamics. Guidance also takes into account the current treatment landscape. We've seen great growth, as we've talked about, with the introduction of new and generic oxybates. So we believe we're well positioned. Given the unique product profile in narcolepsy, we believe that we're well on our way to over a billion-dollar-plus opportunity in this market.
Okay. Maybe just one quick follow-up, just with regards to your comments around first-quarter dynamics. Some of the pieces about the insurance resets that you mentioned are very typical in the industry, and we've seen that with other products as well as Wakix year after year. Is there something in addition to that that you think is gonna come into play? You talked about one other aspect, but I'm not sure if that's gonna have maybe an additional headwind for Wakix.
Well, I would say the two elements of the first quarter, Ami, is we're bringing about 25% more patients into 2024 that are exposed to reauthorizations and prior authorizations. So as you know, it just takes time. It's the nature of the business. So that's probably something that's a little bit incremental than a year ago. And obviously, Change Healthcare is impacting every single brand and every single company a little different. Some individuals are seeing more headwinds on the prescription volume. Some people are seeing more headwinds on the gross to net. But I would say that those two variables, having about 25% more patients exposed to reauthorizations and a little bit more incremental headwinds in gross to net liabilities and potential prescription volume, are things the entire industry is facing.
So I think that's something that you're likely gonna hear from many organizations as you go through, you know, your four-day conference here and as you lead up into the first quarter earnings.
Yeah. Okay. And just with regards to, you know, you mentioned the entry of, you know, other sort of oxybates in the market. Has that had any impact, either the launch of LUMRYZ or any of the other sort of authorized generics of Xyrem? Has any of that had an impact on either utilization or pricing of WAKIX?
So, Ami, I mean, the simple answer is that we really haven't seen any impact with the introduction of the generic oxybates or the once-nightly oxybate in 2023. We've seen durable growth and strong performance going back to our launch. When we had one branded version of oxybate, there have been multiple branded and generic versions introduced along the way. And I think it goes back to that unique product profile, polypharmacy nature of the business, and our ability to tap into those non-REMS-enrolled healthcare professionals to fuel our continued growth. So, you know, for as patients and prescribers kind of transition across the numerous oxybates in 2024, you know, we believe that we're really well insulated. We haven't seen any impact to our managed care plan. We haven't seen any impact on pricing.
We believe that we're gonna continue to grow, moving forward, and our ability to help additional patients living with narcolepsy.
Okay. Now, you know, you talked about sort of the longer-term growth potential of WAKIX. And I think one common question that we get from investors is the impact of the orexin agonist class on the treatment paradigm, particularly in NT1, if we are going to see strong efficacy. You know, could that potentially eliminate the need for polypharmacy in this market? And how could that impact a drug like WAKIX?
Yeah, Ami. So I think, you know, I'll share a few thoughts, and then I ask Kumar to, you know, to weigh in as well. I think that, you know, the orexin 2 agonist class really, you know, very interesting development programs. And as we've said, the next novel, you know, potential novel mechanism of action in treating narcolepsy, especially NT1, you know, really since WAKIX was launched, you know, which was the next, you know, the novel mechanism in over a decade in the market. I think it's our thinking that, between EDS and cataplexy, it'll continue to be a polypharmacy market, and, you know, we follow these programs very closely, obviously. In our business development activities, you know, we are, you know, looking at potential opportunities, because it is such an important new target.
Obviously, Takeda's program being most advanced, and Alkermes will be coming out with some phase II data, you know, later this year. But I, I think sort of at a base case, it, you know, we believe it'll continue to be a polypharmacy market, you know, looking for potential, you know, opportunities in this space. And, Ami, what's interesting too is if you look at, you know, sort of, a scientist by training, if you look at the mechanisms, there is potential, you know, synergy, you know, between orexin 2 agonists, you know, and pitolisant. You know, orexin neurons connect to histamine neurons. The circuitry is, is similar, and there is a synergy between those, those mechanisms. So, we are following the space closely, you know, of how the, the current programs are going forward.
You know, other than Takeda, they're still relatively early coming, you know, to market maybe later, you know, towards the end of the decade and into the 2030s. Kumar, any, any additional thoughts?
No, I think you covered pretty much everything, Jeff. Thank you. Look, Ami, any novel mechanism of action, right, they're always welcome. From patients' perspective, it helps increase awareness in the field, and it'll also energize the field in general whenever there is a novel mechanism of action. But given the large patient population, a significant diagnosed number of narcolepsy patients, where polypharmacy is the norm, we don't believe that any one particular mechanism of action will be able to address all the symptoms of narcolepsy. And it will continue to be a polypharmacy market, and new mechanisms of actions are always welcome. And as Jeff said, we are following this space very closely. Most of them are still in early stages of development. We'll watch this space. And, there are some synergistic mechanisms between orexin receptor agonists and histaminergic mechanisms like pitolisant.
Okay. Well, the other sort of topic at the top of mind for investors is idiopathic hypersomnia. You mentioned that you've completed your meeting with the FDA and will provide an update at the earnings call. Anything that you would like to comment on today and here, or should we leave it for the earnings call?
Yeah. Ami, I would say stay tuned for, you know, the earnings call. We're, we really were waiting for the FDA final, you know, final meeting, minutes, later this month. And as we've said, we're looking forward to providing, you know, the update at our next earnings call and what, you know, that path forward, you know, will look like. We had a very good engagement with the agency, good discussion, Kumar and his team, and we'll provide that update on our next earnings call.
Okay. Let's talk about the new formulations that you're working on, and you're gonna provide us with an update on the data that you're generating. If you could sort of put in context for us the two formulations in development, what are they intended to do in terms of differentiation from the WAKIX clinical profile, as well as the potential for either of the two formulations to perhaps extend IP beyond the current patents for WAKIX? If you could sort of take us through that.
Yeah. Go ahead, Kumar.
Sure. Thank you, Ami. Look, at a very high level, we are working on two different formulations. NextGen1, we call it as NG1, and NextGen2, which is NG2. Both of these formulations are pitolisant-based formulations. NG1 is a modified formulation of pitolisant. It's really an opportunistic fast-to-market strategy with an abbreviated development program and with a very important clinical differentiation compared to WAKIX. We'll be providing more details on what those clinical differentiation would be at our upcoming earnings call. NG2, on the other hand, is an enhanced formulation of pitolisant, where we will try to optimize some of the PK parameters of pitolisant and also the ability to go to a higher dosage strength.
This is the program that will have a full development program, and this is the real value driver in the sense this will have its own IP and will extend the pitolisant franchise well beyond 2040. With this particular formulation, we are looking at several indications. As we have mentioned previously, potentially we could move DM1, where we see a significant opportunity to NG2 formulation. As disclosed previously, both of these formulations entered into the clinic late last year. We plan to have the PK data in the first half of this year, and we'll provide some updates at our upcoming earnings call.
Maybe give us a sense of sort of what type of data can we expect to see at the earnings call from either of these two formulations?
Yeah, we'll be getting some PK data, and that's what we will be sharing within the first half of this year. At the earnings call, we'll provide more updates.
Got it. Okay. That's helpful. Perhaps if you could clarify for us what indications do you intend to develop, either with the NT, NG1 or NG2?
Yeah, with NG1, it will have because it's an abbreviated development program shown by our equivalents to WAKIX, it will carry the same label as WAKIX. But as I mentioned before, we are planning to have some clinical differentiation, an important clinical differentiation that we'll be discussing later. And with NG2, as mentioned earlier, the DM1 is one of the indications that we'll be pivoting towards NG2. And we'll also be looking at our base franchise like narcolepsy, excessive daytime sleepiness, cataplexy, but with the differentiation, targeting certain symptoms, potentially fatigue, which is very prevalent, high unmet need for which there are no treatments that are approved.
Based on the optimized PK formulation and our ability to go to higher dose strength, we believe that this formulation will be uniquely suited to treat some of the symptoms like fatigue in addition to excessive daytime sleepiness and cataplexy in patients with narcolepsy, especially based on the data that we already generated in DM1, where pitolisant showed really clinically meaningful and significant benefits, not just in excessive daytime sleepiness but also in fatigue.
Yeah. And, Ami, just to add, you know, as this program goes forward with NG2 and the opportunity with new IP and a longer runway, we're sort of, you know, gaining more clarity on the opportunity. So as Kumar said, you know, working off of the current indications, but we would also, and we continue to evolve our thinking, you know, IH, a path forward with WAKIX, but also an opportunity with NG2 for a much longer time in the market is a consideration. And we also are looking, you know, longer term, as Kumar mentioned, the strong signals in fatigue. Could we grow into a sort of bigger indications? And there are a lot of neurologic disorders have fatigue as an important symptom, such as MS, multiple sclerosis, Parkinson's.
So, given the long runway, this NG2 opportunity could open up the existing indications to carry forward beyond the WAKIX LOE and potentially bigger, you know, indications in with neurologic disorders.
Got it. Okay. Let's move to Zynerba, where you're running a Fragile X syndrome. can you remind us of the drug's mechanism and, and the rationale for why it should work in Fragile X patients?
Sure, Ami. Look, ZYN002, just a reminder, it's the first and the only synthetic cannabidiol that is pharmaceutically manufactured that is completely devoid of THC, which means that potentially it could be a non-scheduled drug with an absorption-enhanced gel. Just the product attributes itself provides a lot of differentiation and advantages for cannabidiol gel. For example, unlike oral cannabidiol, it lacks significant AEs like nausea, vomiting, diarrhea. And the fact that it avoids the GI tract means that the drug also bypasses the entire hepatic circulation, and therefore there is no impact on liver. So we haven't actually seen any significant abnormalities in liver function tests. So that's from a Fragile X syndrome, from a mechanism of action perspective, at a very high level, the Fragile X syndrome disrupts the endocannabinoid system.
ZYN002 modulates the endocannabinoid system by acting via CB1 receptors. If we go one level further, the endocannabinoid system really is responsible for synaptic homeostasis and synaptic plasticity by providing a feedback mechanism via CB1 receptors, and that is disrupted. ZYN002 acts as a negative allosteric modulator on CB1 receptors and restores the endocannabinoid system balance. So that's at a very high level how ZYN002 is expected to help Fragile X syndrome. we did see this. We saw that in the open label study, that legacy Zynerba conducted, and we saw signal, especially in patients who had complete methylation in the RECONNECT study, which was a large study with over 200 patients. The current RECONNECT study takes the totality of the data that is generated that's what, into account, in terms of design, duration, dosing rhythm, and the primary endpoint, all of those things.
Okay. Firstly, just regarding the ongoing RECONNECT study, you mentioned that you should be able to complete that in the first quarter of next year. Maybe if you could sort of give us some color on, you know, since you've owned the asset, what have you done with regards to getting sort of confidence around enrollment of the study and being able to complete it within sort of that, you know, foreseeable timeframe? And then I kind of wanna ask about some of the design elements as well.
Yeah. Go ahead.
Kumar, just yeah, just some initial thoughts. And then, Kumar, please, you know, please chime in. Ami, first, I you know, I think that, you know, we're really pleased with how, you know, Kumar and the team in terms of, you know, the integration after the Zynerba acquisition and really were able to sort of very effectively, you know, kind of integrate in, and especially, you know, those that were working on the RECONNECT trial and the clinical team, clinical operations team, in a very smooth integration to sort of, you know, keep that momentum. You know, I think from there, Kumar and the team, you know, really took a quick, you know, a sort of close look at, you know, the enrollment and, you know, what was happening. And then really we just sort of applied our resources.
You know, we had, you know, our resources from a clinical operations perspective, and then our patient advocacy team that is a really talented group of individuals, you know, sort of jumped in to engage with the Fragile X community, to increase the awareness, you know, of the trial and our activities there. Kumar, anything further?
Thank you, Jeff. Look, I mean, we know our frontiers, right? This is our fifth program in this particular space. We know this space very well. We looked at the historical recruitment trends. As Jeff mentioned, we were able to reinforce, with some of the unique things that Harmony brought to the table, like patient advocacy groups, really going where patients are and trying to help them get to the clinical trial center, provide the white glove service, all of those things. We took all of those things into account. Based on our evaluation, we believe that we should be able to complete recruitment in the first quarter of next year and get to top-line data in the middle of 2025.
Thank you. You know, the other thing I wanted to talk about was, you know, with regards to the CONNECT study, while the primary endpoint missed, the p-value for patients with greater than 90% methylation was statistically significant. And so what changes have you made based on the learnings from that trial? And, you know, from an FDA regulatory perspective, what gives you confidence that the current design of the RECONNECT study will be sufficient for approval?
Right. Ami, the current study was aligned with the FDA in terms of, well, the study design, the patient population, the duration of the study, and the primary endpoint. So there is FDA alignment on the study design and, the registration ability of the study. The primary endpoint is powered for complete methylation patients only. So we are recruiting approximately 200 patients. 80% of those patients are patients with complete methylation, and the other 20% are patients with partial methylation. And the primary endpoint is powered for those 80% of patients who have complete methylation. So that's from the regulatory perspective, the second part of your question. And regarding the first part of the question in terms of methylation, the confidence, and the mechanism of action, based on the CONNECT study, you are absolutely right. The primary endpoint did not meet statistical significance when you look at the total population.
But if you look at the patients who had greater than 90% methylation, which was above 80% of the patient population, there was a nominal statistical significance of 0.02. What we also noticed is the higher the methylation, the greater the severity of the symptoms, and larger was the effect size. That's what we noticed. And we took that learning into our RECONNECT study. So that's the main thing. The study is focused on patients with complete methylation, and the primary endpoint is powered for complete methylation. In addition, we also made some changes like increased the duration of the study, went up on the dose slightly higher on patients who weigh more than 50 kilograms. So those are some of the minor changes that we also made, which basically increases our confidence.
We are optimistic about this study and really bringing a medication, really a medication, because there is nothing approved in this patient population, bringing something that will be clinically meaningful for patients Fragile X syndrome who have been looking forward for any approved medications for a long, long time now.
Can you also talk about the, sort of, potential utilization of this drug in the 22q11.2 deletion syndrome? And what work are you doing currently to explore that?
Yeah. With 22q, and it's another, very similar, yet Fragile X syndrome in the sense there are about 80,000 patients in the U.S. Fragile X syndrome. also just, to remind, this is a global opportunity for us. So going back to 22q, we have data from a phase II open label proof of concept study where ZYN002 did show clinically meaningful and nominally statistically significant changes in several of the domains of ABC checklist, like irritability, agitation, which are very common and prevalent and bothersome symptoms that are noticed in 22q deletion syndrome. We are working with the FDA to gain alignment on the primary endpoint. In the meantime, we are also working on the finalization of the protocol.
Once all of those works are done, at the appropriate time, we will let you know when we will begin our phase III program in 22q11.2 deletion syndrome.
Okay. I wanna switch gears and talk about a little bit of, you know, allocation of resources. You have a $150 million share repurchase program outstanding, which you announced, and, you know, you've utilized a fair sum of that. How should we anticipate you sort of continuing to repurchase shares in the context of also, you know, your comment earlier that the company continues to be active on the business development front?
Yeah. Hi, Ami. I would say, you know, we see both business development and it certainly is a high priority. And, you know, we're certainly, as Jeff mentioned, active in this space. We don't really see share repo as an either/or situation. Just to give you an example, last year we did do about $100 million of share repurchase. And actually, in the fourth quarter, we did about $50 million of share purchase. And we also closed on the Zynerba transaction as well. So we see share repurchase as opportunistic, you know, and we'll deploy capital as appropriate. And, you know, and we have, as you mentioned, about $150 million of authorization. And we'll provide updates to the investment community, you know, during every earnings call in terms of how on our progress along and with both of those areas.
With regards to the business development front, what type of transactions should we anticipate? You know, I'm sure you're looking at a wide range, but what would you like to do? You know, would it be an early stage or a Zynerba-like transaction or something even more transformative?
Yeah, Ami. So our strategy in business development, you know, similar to the Zynerba acquisition, you know, that, that we executed on. So I think that, you know, our, our main filters, if you will, the strategy in looking in, you know, orphan rare CNS neurological disorders or, you know, neuropsych, neurobehavioral programs like the, you know, the Zynerba acquisition. So within, you know, that, you know, that space, we also tend to look at mid to late stage development programs, you know, closer to market, with regards to, you know, optimal opportunities with where we see the current, you know, profile of the company. But at the, you know, at the same time, we wouldn't shy away from opportunities that may be larger or more transformative, if we feel that there's a, a really good strategic fit.
You know, and you know, we have the ability to transact and access to capital, as Sandip can comment on, you know, for those larger opportunities where we feel, you know, it would be a very good strategic fit, you know, where it's sort of a balance. We're mindful. We like the profile of the company where we are, you know, being profitable and cash generating. But with regards to the longer-term growth strategy, you know, we understand that, you know, we may have to make some moves that provide for, you know, greater growth opportunity, you know, going forward.
Yeah. And I'll just add. I mean, as you mentioned, we've got $426 million as of the end of last quarter. We continue to generate positive cash flow every quarter since back last year. In the fourth quarter, we generated about $77 million of free cash flow from continuing operations. So I think we have great capacity just from our ongoing business itself. But we also have access to the public markets, if needed, as well as we did also a term loan last year. So certainly access to the debt markets. So I think we have the opportunity to not only use our overall profile as a company. And like Jeff mentioned, we like the profile. We like that we're profitable, cash flow generating, and, you know, being able to leverage that to potentially more larger business development transactions as well.
Okay. Looks like we're almost out of time. So I'll have to close here. But it was great to host everybody. And thank you so much for taking us through different aspects of the company. And wanted to thank our listeners for joining us for this session as well.
Thank you, Ami. Thanks for having me.
Thank you, Ami. Thanks again.