Q4 2023 Fennec Pharmaceuticals Inc Earnings Call
Participants
Robert Andrade; CFO; Fennec Pharmaceuticals Inc.
Rosty Raykov; CEO & Director; Fennec Pharmaceuticals Inc.
Adrian Haigh; COO; Fennec Pharmaceuticals Inc.
Noreen Qubier; Analyst; Capital One Securities
Chase Knickerbocker; Analyst; Craig-Hallum Capital Group LLC
Dipesh Patel; Analyst; H.C. Wainwright & Co.
Presentation
Operator
Good morning, ladies and gentlemen, and welcome to the Fennec Pharmaceuticals fourth-quarter and full year 2023 earnings and corporate update conference call. (Operator Instructions) As a reminder, today's conference is being recorded.
Now I would like to turn the conference over to Fennec's Chief Financial Officer, Robert Andrade. You may begin.
Robert Andrade
Thank you, operator, and good morning, everyone. We appreciate you joining us today for Fennec Pharmaceuticals' fourth quarter and full year 2023 earnings conference call, during which we will review our financial results as well as provide a general business update. Joining me from Fennec this morning are Rosty Raykov, our Chief Executive Officer, and Adrian Haigh, our Chief Operating Officer.
Before we begin, I would like to remind you that during this call the company will be making forward-looking statements that are subject to risks and uncertainties that may cause actual results to differ from the results discussed in the forward-looking statements. References to these risks and uncertainties are made in today's press release and disclosed in detail in the company's periodic and current event filings with the US Securities and Exchange Commission.
In addition, any forward-looking statements made on this call represent our views only as of today and should not be relied upon as representing our views as of any subsequent date. We specifically disclaim any obligation to update or revise any forward looking statements. This conference call is being recorded for audio rebroadcast on Fennec website, www.fennecpharma.com where it'll be available for the next 30 days.
And now I will turn the call over to Rosty Raykov. Rusty?
Rosty Raykov
Thank you, Robert, and good morning, everyone. On today's call, we'll detail our fourth quarter and full year 2023 financial results, all of which were outlined in our earnings press release issued this morning prior to this call. We'll also discuss ongoing commercial launch efforts and the progress that we're making with PEDMARK in the US and provide details on the exclusive licensing agreement we announced on Monday with Norgine to commercialize PEDMARK in Europe, Australia, New Zealand.
As you may recall, we announced preliminary unaudited fourth quarter and full year 2023 net revenues at the end of February and we're pleased to report that PEDMARK delivered fourth quarter revenues of approximately $9 million. This brings our full year 2023 net revenues of approximately $21 million. It was an exciting year for Fennec given the strong performance with PEDMARK in the full fiscal year following its US commercial launch.
We're pleased with our execution against strategic plans and our momentum in '23, which sets us the stage for further success in '24 and beyond. We continue to be very encouraged with the progress we've made, and we're even prouder of the work that is underway to sustain this momentum throughout '24 and beyond.
Earlier this year, we announced that the FDA issued a public communication that is aware that some providers may be preparing other sodium thiosulfate products for patient use in place of PEDMARK, including the looting at STS product approved for other uses to match the strength of PEDMARK.
The FDA reminded health care providers that are stated in PEDMARK prescribing information, PEDMARK is not substitutable with auto sodium thiosulfate products. The FDA stated such substitution both potential health risks, including, but that in chloride exposure, which is high doses can lead to increased risk of acute cardiac events and other serious adverse reactions.
Potassium chloride is not present in PEDMARK. Our exposure to boric acid can cause health risks, including headache, hypothermia, restlessness, weariness, renal injury, dermatitis, alopecia, anorexia, and indigestion. Although PEDMARK also contains boric acid, it is at a lower concentration than other STS products.
Overexposure to sodium nitrate, which can lead to health risks, including methemoglobinemia. Sodium nitrate is co-packaged with sodium thiosulfate as a separate vial in some products, it is not present in PEDMARK.
The public communication was issued (technical difficulty) [National] Affairs and stakeholder engagement staff with a Center for Drug Evaluation and Research office of communication. We are pleased with the FDA reminder to providers of this issue, which supports our educational efforts in establishing PEDMARK as a necessary complement agent when prescribing cisplatin based therapy for appropriate patients with a localized non-metastatic solid tumors.
To that end, earlier this month, we sponsored an educational problem with Met safety board, a subsidiary of the Institute for safe medication practices or ISMP, which expert faculty Rita Jew and doctor [Norfaterman] reviewed therapeutic considerations for reducing the risk of cisplatin and use all existing pediatric patients.
Regarding our commercial efforts, our sales force continues to target approximately 200 pediatric hospital centers, including COG, [NTRI] and NCCN and institutions across the US that drive 80% of pediatric cisplatin use.
We're also continuing to build upon our commercial momentum through expanding the prescriber base to the community, increasing the utilization of the recent endorsement from the NCCN for PEDMARK in the adolescent and young adult AYA patient population.
To be clear, our FDA indications, pediatric and our commercial teams are only promoting our FDA indication. PEDMARK also continues to have broad in favorable payer coverage as evidenced by their approved US prescription claims with commercial insurance plans and Medicare Part D plans. As a reminder, we estimate among current PEDMARK patients approximately 50% of commercially insured with another 50% insured through government-sponsored programs.
With regards to our evaluation of the best commercial path in Europe, we were pleased to announce on Monday that Fennec has entered into an exclusive licensing agreement with Norgine, a leading European specialty pharmaceutical company, under which no Norgine will commercialize PEDMARK in Europe, Australia and New Zealand.
PEDMARK is the first and only approved therapy in the EU and UK for the prevention of all the existing induced versus modern chemotherapy in patients one month to 18 years of age and localized not metastatic solid tumors.
Under the terms of the licensing agreement, Fennec received approximately USD43 million in upfront consideration and the potential for up to approximately [$230 million] in additional commercial and regulatory milestone payments and tiered royalties on net sales of PEDMARQSI in the licensed territories up to the mid-20s.
Norgine will be responsible for all commercialization activities in the licensed territories and we call all marketing authorizations. This partnership represents an important step in achieving our mission of expanding PEDMARQSI to patients across the globe who are at risk of suffering for [sloughing] and new sort of SEC.
From a deal perspective, the term provide us with many important benefits, including an upfront payment for to solidifying our balance sheet, attractive economic terms, providing meaningful participation in the ex US success of PEDMARQSI, an experienced partner to successfully launch PEDMARQSI in the licensed territory.
In closing, I want to reiterate that the focus of our commercial strategy remains on executing the following establishing PEDMARK and necessary complement agent when prescribing this platinum-based therapy for appropriate patients with localized non metastatic solid tumors, minimizing the barriers to access and ensuring rapid responses to product questions and inquiries and establishing (technical difficulty) a partner of choice in the oncology in patients and community settings.
With that, I will now turn the call over to Adrian, who will provide an update on our commercial strategy and operations. Adrian?
Adrian Haigh
Thanks, Rosty. As a reminder, we estimate that in the US there are approximately 3,500 on-label pediatric oncology patients. The majority of these are treated in the specialist pediatric centers and receive an average of 12 vials per patient. Conversely, there are more than 25,000, 15 year old to 39 year old cancer patients, many of which receives this platin. And as Rosty said, the NCCN has recommended PEDMARK for this defined patient population with 2A rating. Taking testicular cancer as an example, there are approximately 3,800 patients and the majority of these are likely to receive high-dose assisted (technical difficulty) putting them at a very high risk of hearing loss.
The average testicular cancer patient due to a weight-based dosing requires many more vials with PEDMARK than the younger pediatric patients. Testicular cancer has very high cure rates. (technical difficulty) beyond, but in such cases, hearing loss is lifelong and devastating.
The unmet medical need for preventative treatment is clear. There is a very strong health economic argument that justifies spending on preventive treatments. These patients are exclusively treated in the community hospitals and infusion centers. AYA patients with cervical, ovarian, and head and neck cancers are also likely to be treated with this strategy. And again, if prescribed will require a significant number of vials of PEDMARK.
Since November, our salesforce has primarily focused our activities on the community treated population. We have been very encouraged by the community's response to PEDMARK. Most of them, whilst being acutely aware of the hearing loss caused by cisplatin were not aware of the availability of a preventative treatment incorporating PEDMARK into the treatment schedule requires some adjustment to current practice.
For example, infusion [clicks] may have to stay open for an extra hour or so in order to accommodate the need to administer the PEDMARK six hours after the end of a suspected infusion. All of this takes some time to put in place.
Consequently, we focused our efforts during the last few months on disease awareness and treatment awareness and then subsequently working with the centers on the logistics of administration. We're essentially just a couple of months into what is in effect, a new launch with PEDMARK. But we're encouraged by the reception we've received. Patients have already been treated and reimbursed by payers. As we look forward to the conference season and in particular to [Asco], we intend to appropriately educate all oncologists and create awareness of PEDMARK.
We had to deal with one barrier to uptake and I'm pleased to say that from April 1, this has been resolved. Prior to April 1, 2024, our J code did not differentiate between PEDMARK and other formulations of STS has a consequence there has been some confusion and impact to the adoption of PEDMARK.
We informed CMS and in January 2024, CMS issued a new J-code for the whole product and met and amended our J-code to specified PEDMARK. Importantly, CMS has also stated that the two formulations are not interchangeable. To repeat this important change will become effective on April 1, 2024, and we do expect significant acceleration in uptake as a result.
As Rosty mentioned, on January 8, the FDA issued an e-mail reminder that PEDMARK cannot be substituted with other formulations of STS due to significant safety concerns. As this e-mail was not sent individual doctors, individual pharmacists, or hospitals, but rather to organizations, for example, Asco and the American Hospital Pharmacists Association, our safe sales force has been working to create further awareness of this notice to pediatric hospitals.
As a result, a significant number of hospitals have scheduled new formulary committee meetings to discuss the FDA notice and some have already ceased compounding. Again, this doesn't happen overnight, with many meetings taking place on a monthly or bimonthly frequency.
I'm also pleased to report that the American Hospital Pharmacist Association drug information resource HSAHFS has recently been amended to clearly differentiate between the various formulations of STS, and clearly states, they are not substitutable.
So in closing, I'm very pleased with the progress we are making, and I'd like to thank the commercial and medical affairs teams for the tremendous effort they've made over the last few months, and I look forward to seeing acceleration in revenue.
With that, I'll turn the call over to Robert to go over the financials for the quarter and full year results. Robert?
Robert Andrade
Thank you, Adrian. Our press release contains details of our financial results for the fourth quarter and full year of 2023, which can be viewed on the Investors and Media section of our website. Rather than read through all of those details my comments today will focus on some key financial results.
The company recorded net product sales of PEDMARK for our first full fiscal year after launch of approximately $21 million in fiscal '23 with over $9 million in the recent Q4 2023. This compares to $1.5 million in fiscal year and fourth quarter 2022. The increase in net sales reflects strong growth in new patient starts and accounts. GNA for the 2023 fiscal year increased by $2.3 million compared to the 2022 fiscal year. This increase is largely attributable to payroll and benefit related expenses, which rose approximately $1 million and higher noncash stock-based compensation.
Selling and marketing expenses including renumeration of our sales and marketing employees, dollars spent on marketing campaigns such as sponsorships, tradeshows and presentations and any activities to support marketing and sales activities.
The company recorded $12.1 million in selling and marketing expenses in fiscal 2023 compared to $2.8 million in fiscal year 2022 as a launch of PEDMARK commenced in fiscal in fourth quarter of 2022. R&D expenses are negligible, as we've mentioned before as the company reduced research and development costs when it received FDA and EMA approvals of PEDMARK. The majority of traditional research and development expenses associated with PEDMARK are now recorded as GNA expenses or capitalized into inventory and eventually recorded the cost of product sale.
Our net cash used in operating activities was $16 million in 2023, which is consistent with our approximately $25 million in annual cash operating expenses prior to any contributions from net revenue. Further Q4 2023 and the first 6 months of 2024 have additional expenses associated with the internal preparation for the EU launch, which with the announced partnership with Norgine we anticipate these EU expenses to tail off significantly in the second half of 2024.
And finally, our cash position, we ended the year with approximately $13 million in cash, cash equivalents and investment securities, which included the December 2023, third closing of $5 million senior secured convertible notes under the existing agreement with Petrocorp.
The original investment agreement provided access to up to $20 million of additional financing through December 31, 2023. As part of this closing, Fennec and Petrocorp have amended the agreement to provide access to up to $15 million of additional financing through December 31, 2024.
In addition, and importantly, as announced earlier this week, we received approximately $43 million from the licensing of Europe, Australia, and New Zealand to Norgine. Inclusive of the licensing transaction pro forma December 31, 2023 cash balance is in excess of USD56 million.
We anticipate that our cash, cash equivalents and investment securities as of December 31, 2023 when coupled with PEDMARK revenue assumptions and the recently announced license agreement for Europe will be sufficient to fund our planned operations for at least the next 12 months.
And operator, with that, we are ready for questions.
Question and Answer Session
Operator
(Operator Instructions) Noreen Qubier of Capital One Securities.
Noreen Qubier
Hey, good morning and congrats on all the progress, and thanks for taking my question. So I was just wondering if we thinking about the quarter -- last quarter in terms of the growth, was it more from your account to repeat prescribers? And when do you think the contributions from the AYA group will filter in?
Rosty Raykov
Yes, hello. Yes, I would say overall was really the hospital, the existing accounts, a few newer ones, I would also say that we did have several patients that started treatment that were in the AYA population and its agent attributed the vial usage in those patients is significantly higher. But as you can imagine, those were also in the context of a CMS J-code issue that has been resolved starting April 1.
Noreen Qubier
Okay, terrific. And congrats on the licensing deal. I was just wondering -- maybe to related to them, so when will that transfer the help -- the technology at the 80 dose here with any relevant materials, has that already occurred with Norgine? And do you expect to maintain the time lines for launch in Europe in the second quarter?
And finally, related to that, who is going to pursue the regulatory approval, I think you may have mentioned it, but I'm not sure, in Switzerland and Australia and New Zealand?
Rosty Raykov
Yeah, this is over to Adrian.
Adrian Haigh
Yeah. So the second questions are easy to answer. The Norgine will be responsible for everything regulatory in the licensed territories. So we've already begun the process of transferring the European and UK licenses to Norgine. They will be responsible for applying in Switzerland, Australia, and New Zealand, and we already have begun the process of introducing Norgine to help technology vendors.
The Norgine will takeover or has taken over responsibility for the management of those vendors. It's not for me to comment on when Norgine will choose to launch, I think they'll probably let the dust settle and evaluate where they are. So I would be anticipating a European launch probably in the second half of the year just for logistical reasons.
Noreen Qubier
Sure. All right. Thank you so much. Thanks for taking my questions.
Adrian Haigh
Pleaure.
Operator
Chase Knickerbocker, Craig-Hallum.
Chase Knickerbocker
Good morning, guys. I wanted to share my congrats as well on the EU licensing deal. Really nice deal you negotiated there. I'm going to start there. Maybe that color is helpful around Norgine's plans kind of maybe second half of the year from a launch perspective. Maybe kind of building off that, they appear to be set to launch the [Florida] [theme] in the near future as well and seems to be like they see some sort of strategic kind of rationale and the synergies there. Can you kind of speak to the excitement level that Norgine has kind of launching those two assets together?
And then second on that, you just had to be -- in my opinion, a pretty competitive process to get the strong terms that you received. Can you give us any sort of insight and how potential partners we're thinking about strategic value of PEDMARK as you kind of went through this process, not only in EU but globally and in the US as well?
Rosty Raykov
And maybe I can start with the second half of the question and then I will turn it over to Adrian. In terms of the value proposition that PEDMARK seeing PEDMARK offers, as you know, it's very difficult to get a product approved. It's been 14 years in the making and it's very rare for anyone to develop a product in the pediatric oncologist setting.
We also did an outstanding job. We're not just getting this product approved, but also setting it up for success in Europe, and that's largely to Adrian's efforts that we're underway since he joined us in August. So I think that set the stage up for an asset that is ready to get ultra rare for an asset that is ready to launch (technical difficulty) largely of all the risk is basically off the table. And this is something very, very attractive to, as you could imagine, many, many parties, especially when there's a specific need and market for a very, very unique product. So maybe, Adrian, you could discuss the first part of the question in terms of the overall direction to Norgine will take this forward.
Adrian Haigh
Yeah. So I think I mentioned on the previous calls, the work that we've been doing over the last six months or so with European health technology vendors has brought us to the conclusion that we can get a pretty significant price in Europe. And as -- you're correct in saying that it was a competitive process and a number of the potential suitors all came to that conclusion. It became clear to us that the suitors were -- we are very excited about the potential of the product were prepared to commit significantly more resources than we would have been able to do given our other priorities in the US.
And if it got to -- it became very competitive. We had a number of very high quality European specialty pharma companies that were prepared to invest significant resources in PEDMARK. I'm absolutely delighted with the partnership with Norgine and they're completely bought into the concept. We're completely aligned on our pricing assumptions. They see this, as you said Chase as highly synergistic to the growing portfolio in pediatric oncology, and they're prepared to put very significant resources, both in terms of people and cash to support the launch. If that answers your question?
Rosty Raykov
Yeah, no, that's helpful. Maybe digging in a little bit more on the J-code issue. This is a kind of nuanced question, but it's not -- and so there's going to be a separate J-code for the other STS product. Is there any chance that there's any sort of confusion around the ASP reporting for your J-code from a standpoint of -- is there going to be some sort of ASPs that were reported for the other products that get included in your J-code? Or is that going to get taken out?
Adrian Haigh
That's certainly has been the confusion, that's going to be taken out. So it very clearly says STS, PEDMARK and then it says STS hope and there's also footnote there saying the products are not interchangeable. So --
Chase Knickerbocker
And if you guys are confident that the ASP is going to be accurate for your J-code to reflect the pricing of your product starting April 1?
Adrian Haigh
Yes.
Chase Knickerbocker
Got it. And if we kind of think about how that kind of parlays into maybe some of the confusion that was seen in AYA population and those physicians. I mean, how should we think about potentially though some volume kind of coming in that April 1 timeframe that once that confusion is kind of corrected, do you have a good handle on what kind of volumes out there that wasn't using your product?
Rosty Raykov
Yes. So what I would say, Chase is that as you know, this is not a chronic treatment. So you don't -- sort of have patients just waiting for it. It's really when the patient starts and then when the patient finishes with the cisplatin treatment.
So overall, we visited many of these community oncology centers where the defending for plotting infusion takes place. And as Adrian mentioned in his comments, this is where the volume of splatting is administered for these patients and also where PEDMARK would be administered in this AYA population. So I think we have to wait and see how this plays out. But again, based on the numbers, we're highly encouraged that this would be well received.
Chase Knickerbocker
Great. And then maybe one more around the business and then one on financials. Just around the FDA communication, first of all, have you seen kind of any influx in kind of volume from that or subsequent to that communication?
And then second, can you just update us on some of the metrics that you gave last quarter as far as kind of being in 20% of those 200 institutions and the max -- kind of being 25% penetration into an institution. I'm sorry if I missed that, but just an update there?
Rosty Raykov
Yeah. So maybe, Robert, you can address that and then maybe Adrian you can address the earlier part.
Robert Andrade
Yeah. Chase, I mean, our penetration continues to grow. I think that's reflective certainly in our net revenues. We don't want to get set ourselves up on the guardrails and in particular also as we expand in the market with the AYA population and the community hospitals. So those basis, the 25% and the [20%] have certainly grown, but we're going to shy away from getting into the specifics gross numbers at this time.
Rosty Raykov
And Adrian, maybe you could a shine a word or two. I know you had in your prepared remarks in terms of how the P&T committees in hospitals take this FDA safety communication and how quickly they affect change?
Adrian Haigh
Yeah, as I said, they unfortunately, this wasn't the sense to individual doctors or hospitals or pharmacists. It was sent to organizations. I think it's about 12 different organizations. And initially, when our sales force went out, have you heard about the recent communication from the FDA? No, haven't seen it. So the salesforce would have to basically go out with the laptops and show the e-mail.
And then things don't happen overnight. This has to go through a formulary committee process, it has to be discussed, people to get buy-in. And so these formulary committee meetings, in most cases are just been scheduled or just about to take place. There's a handful that have stopped compounding immediately, but this takes time. So we have seen some increased use, but it's not like switching a lifetime, it's slow, it slow.
Chase Knickerbocker
Got it. And then just lastly, Robert, apologies for taking up too much time guys, but I just want to dig in a little bit more on the SG&A. Can you give us a little bit more sense of what was in the quarter, at least benchmark us a little bit that we should consider kind of one-time expenses from any sort of consulting spend or deal-related expenses in Europe? Should we think of SG&A being flat once we back those out from Q3? And then as we look into 2024, how should we phase out those expenses, is that -- are we flat from an OpEx perspective into Q1 and then it starts to phase out? Or how should we think about that?
Robert Andrade
Yeah, I think you have a good benchmark there, certainly in Q4, we did have a good amount of expenses related to our EU preparation and launch, which we believe is well worth it. That will continue. So those SG&A levels will continue into Q1 and start tailing off certainly into Q2 and our understanding is it -- will be just basically go to very little if any for the second half of the year, kind of similar to my remarks.
That helpful, Chase?
Chase Knickerbocker
Great. Yeah, thanks for the questions, guys, sorry. I'll hop back into queue.
Robert Andrade
Thanks, Chase.
Operator
Dipesh Patel, H.C. Wainwright.
Dipesh Patel
Good morning. This is Dipesh Patel on for Ram Selvaraju. Several questions, the first is I'm wondering what are the stocking patterns like for PEDMARK at US hospitals? And how does Fennec expect this to evolve over time?
Rosty Raykov
Yeah, so I'll take that. So there's roughly 200 hospitals that are largely affiliated with COG, NCCN. And those hospitals obviously are the ones that we target. They treat the pediatric patients largely inpatients. Those hospitals they -- as we've discussed in earlier calls, they go through a very rigorous P&T process to approve a drug on formulary before start using it.
We have overall, I would say a limited success in some of those accounts. And now with the FDA communication and the safety risks we're encouraged by that and our sales force as well as our medical team, it's out there educating and as Adrian mentioned, we're in front of many of the hospitals, and we're hopeful that we've seen a little bit of change. But we'd like to obviously see additional in the coming months. So that's really the market in the hospital setting.
As you could imagine, it's not easy to sell in the hospital in general. And so we -- it's actually very, very proud of what the team has been able to accomplish and safety recognition more good news coming there. But again, it's not a light switch that comes on. I think it's gradually, hopefully there's a light switch toward the next three months to six months, but let's see it and then we can discuss it with you guys.
Dipesh Patel
Thanks. I appreciate the color. And my second question on what kind of infrastructure does Norgine plan to use to launch PEDMARK in Europe? And what is the estimated size of the opportunity there?
Rosty Raykov
Yeah, Adrian, over to you.
Adrian Haigh
Yeah, they have a presence in all of the major European markets in Australia and New Zealand and I think back of the envelope looking at allocating around 50 FTEs to the product and what I consider to be the appropriate level of commercial spend to make a success of the products. And they're hiring a mixture of new specialist folks and fill gaps and also reallocating some people. But to be honest, that's a very high level question for Norgine really.
Rosty Raykov
And I would also add because we got to -- we've interacted with several teams in Europe overall. And I would say that what Norgine is really committed to pediatric oncology. Not only did they have our product, but they have another product as well that they're planning to launch roughly at the same time. It's really exciting. It's really exciting because their passion and commitment is right up there with ours. I cannot be more pleased to see a very strong and capable player take on PEDMARQSI and really get access for India in these territories.
So imagine that we're going through 200 hospitals in the NCCN and COG setting. So imagine that with each country and each health care system, health economics argument, et cetera. So it's a major, major task and they have done this many times and they're up for it. And importantly, they're really committed to the space. So this could not be more perfect partner for n PEDMARQSI.
And in terms of the revenue expectations for the product, I would say that what we can model. As Adrian said earlier it's not that [dissimilar] to what they had modeled for it. So I think in terms of milestones and royalties uptake into that, but most of the time in this biotech deals you have a bio [bucks], if you will, and people sort of discount those things heavily. Let's give it a little bit of time, but I think most of these things are very realistic.
Dipesh Patel
Thanks. That's very helpful. And then final question, does Fennec plan to use any of the upfront cash from the Norgine transaction to expand its pipeline? If so, what kinds of opportunities do you plan to pursue whether it's like development-stage assets or approved products? And I think you kind of alluded to this, but I'll ask you the question, is at Fennec long-term -- and is Fennec long-term intent to remain focused on oncology. Thank you.
Rosty Raykov
That's a very good strategic question. I think we just closed the deal. So we -- the Board and management obviously has to evaluate everything from a 360 degrees. We've always been a very, very good stewards of capital. Historically, I hope that to continue going forward.
As you could imagine, the market is full with the assets that need funding. And it's something that we as management and Board would have to decide at some stage. That's what we want to pursue. And we will obviously update the market on that. But for now, we're keeping our head down and we are executing on the opportunity ahead of us. I mean, as Adrian mentioned, from the number perspective, we have greater than 10 times the market opportunity in the community setting, and we're really focused on that.
And what's -- again, what's really exciting is that despite the J-code issue, we've been able to put patients on drug and those patients who have been reimbursable, right, which is really important. So that from here, let's see what we can do in the coming months in terms of overall usage for the product. In addition to what's coming up down the number five with the pediatric hospitals, which again I discussed earlier from a PNT perspective.
Dipesh Patel
Great. Thank you so much for taking my questions.
Operator
And I'm showing no further questions at this time. I would now like to turn the conference back to Rosty for closing remarks.
Rosty Raykov
Thank you. Thank you for the discussion, good questions and joining us today. We look forward to updating you on our continued launch progress and corporate milestones on future quarterly calls. Thank you, and have a great day.
Operator
And this concludes today's conference call. Thank you for participating. You may now disconnect.
