Good morning, ladies and gentlemen, and welcome to the NRx Pharmaceuticals conference call to discuss the FDA approval of preservative-free ketamine. At this time, all lines are in listen-only mode. Following the presentation, we will conduct a question-and-answer session. This call is being recorded on Friday, October 30, 2026. I would now like to turn the conference over to Brian Korb of astr partners. Please go ahead.
Thank you, operator, and welcome, everyone. Before we begin, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities law. These include statements about the timing of commercial launch and first shipments, market size and growth, pricing, manufacturing and supply, and future products. These statements are subject to risks and uncertainties that could cause actual results to differ materially from the present expectations. Additional information concerning these factors is contained in the press release issued this morning and in the company's periodic reports filed with the SEC. The forward-looking statements made during this call speak only as of today, and the company undertakes no obligation to update or revise them. NRx is not providing revenue or margin guidance on today's call. Joining me today is Dr. Jonathan Javitt, founder, Chairman, and Chief Executive Officer of NRx Pharmaceuticals.
Following his prepared remarks, we'll open the call for questions. I will now turn the call over to Jonathan. Jonathan, go ahead. Congrats.
Thank you, Brian. Good morning, everyone, and thank you for joining us. This morning, we announced that the FDA has approved our abbreviated new drug application, or ANDA, for preservative-free ketamine ahead of the November 10 goal date. This is NRx's first approved product, and it marks our transition from a development-stage company to a commercial company. According to the FDA's data, the average time to ANDA approval is 35.6 months. This ANDA took less than 14 months from time of submission. While that's in part a function of the extraordinary team who come to work with us each day and the regulatory lawyers who support us, it's also a function of the recognition that goes from the FDA all the way to the president of the precarious nature of the U.S. sterile drug supply and the urgent need to return sterile injectable drug manufacture to the United States.
Today, nearly 60% of sterile injectable drugs that are critical to the lives of Americans are manufactured overseas. We've seen shocks to our energy supply, even though the U.S. is a net exporter of petroleum. Imagine if we had a shock to our sterile drug supply and surgeries could not be performed for lack of anesthetics or infections could not be treated for lack of antibiotics. Although we will be talking about our first ANDA drug approval today, much of what I will say is generalizable to many drugs. Many investors in our segment don't expect biotech companies to become commercial pharmaceutical companies. However, commercial pharma is where we come from at NRx. Our leadership team has decades of commercial experience at some of the world's largest pharmaceutical companies.
One of our founding board members, Chaim Hurvitz, rose to be president of Teva's international division and served on Teva's board during the years when they pioneered the first treatments for multiple sclerosis and other CNS diseases. Given the sales force resources already in place at our partner Nephron Pharmaceuticals, we are immediately capable of meeting the market demand for our first commercial product, and we embrace the challenge. I want to use our time this morning to cover five things. How did we get here, and what does this have to do with our original mission? Why are we able to manufacture an old generic drug at new innovative drug margins? Why this product matters to patients and hospitals, a bit about the U.S. ketamine market, and how we plan to launch. Then we'll take your questions. How did we get here?
As those of you who have been long-term shareholders know, our company was founded around NRX-101, an oral antidepressant currently being tested in a DARPA-funded phase III trial in combination with transcranial magnetic stimulation. Our original Breakthrough Therapy Designation from the FDA for NRX-101 called for us to stabilize suicidally depressed patients with ketamine, following which they would receive our innovative oral drug. As we discussed with shareholders a few years ago when we met with FDA after COVID to reinitiate our psychiatry program, FDA asked us to seek a label for use of ketamine in depression. That's when we learned how tenuous the U.S. ketamine supply is, when we learned about the benzethonium chloride problem, and when we began to understand why ketamine and most of old sterile drugs like it are no longer manufactured in the U.S.
Most of the cost of manufacture in a sterile injectable drug is actually in the glass bottle, not in the drug. It was the combination of a worsening drug shortage for a $400 million a year U.S. product whose need is much larger overseas, whose demand is growing rapidly, the ability to use modern blow-fill-seal manufacturing technology to make it feasible to return ketamine manufacture to the U.S., and the realization that we could remove an old toxic preservative in the process that led us to seek and obtain FDA approval to sell ketamine for the broad hospital and clinic market, not just for the psychiatry market. This is a path that we had the experience to undertake.
Thirty years ago, Dr. Panicucci, our head of manufacture, and I were involved at different pharmaceutical companies in moving the manufacture of eye drops from preservative-containing bottles to preservative-free blow-fill-seal solutions that have now become standard. However, the solution that worked for dropper tip vials could not work for injectable products because of the need to maintain sterility while drawing the medicine into a syringe. The missing piece was the innovative Luer lock tip developed by our German partners at Rommelag and pioneered at Nephron Pharmaceuticals. Although it is a tiny bit of plastic, you have seen on the FDA website that our innovative vial is classified as a drug-device combination. You saw that it took an extra 2 months to get the ANDA through as we demonstrated the integrity of that product component.
The user studies we have completed with doctors, nurses, and pharmacists tell us that professionals are highly enthusiastic about a medication vial that eliminates the need to affix a needle to a syringe, advance the needle through a rubber stopper of a glass vial, and withdraw the medication. Not only do we cut the staff time in half and eliminate the medical waste, we end the risk of needle stick injuries because with our solution, there is no needle. This newly developed ability to package a sterile injectable drug in a blow-fill-seal vial without the ever-increasing cost of glass bottling substantially reduces our cost of goods and enables us to manufacture and distribute an old generic drug at margins that rival the margins of new innovative drugs. Suddenly, it is economically feasible to restore sterile injectable drug manufacturing to the United States.
Together with the preservative-free nature of our product, the ease of use, and our ability to guarantee supply, we believe we are poised to enter the U.S. hospital and clinic supply chain and displace old generic players who cannot adequately supply quantities of badly needed drugs. At the same time, we remain committed to obtaining an FDA label for treating depression and PTSD with ketamine and are compiling newly obtained data comparing IV ketamine to SPRAVATO that we will share in our next quarterly earnings call. Why is there a supply shortage of ketamine, and why will it get worse without us? Ketamine for injection has been on the national drug shortage list since February 2018.
According to the American Society of Health-System Pharmacists, as of this month, all six ketamine manufacturers have at least one presentation of their product back-ordered, intermittent, or on allocation, and some manufacturers have recently discontinued production altogether. The Secretary of Health and the FDA commissioner have identified ketamine as a strategic drug whose supply in the United States must be assured. As I mentioned, most of today's supply comes from overseas and is made the traditional way in glass bottles. That labor-intensive process has not been economically viable in the United States for decades. We can package 1 million doses of ketamine using blow-fill-seal technology in about the same time as a glass bottling line can package 10,000 to 50,000 doses. More importantly, we do not have to buy pharmaceutical-grade glass bottles and stoppers, which are frequently in short supply and have quality problems of their own.
All we need to buy is a few plastic pellets and let the machines do the rest. Our belief is that the reason for the shortage of ketamine and other old injectable products is that manufacturing costs have risen to the point where suppliers are somewhat indifferent about supplying and are reallocating their manufacturing capacity to biologics and other high-margin products. This has created a unique commercial opportunity for us together with our partners. Preservative-free ketamine is made in West Columbia, South Carolina, by our partners at Nephron Pharmaceuticals on high-speed blow-fill-seal lines with no glass. You might ask, "Why won't the rest of the world copy us?" Well, certainly some will, but the innovative Luer lock tip that enables the process is proprietary. The technology cost is high, the skill set required to implement the technology is higher, and we have a head start.
In fact, we're in the process of taking delivery of additional manufacturing lines from Germany to meet the rapidly emerging demand. Today's approval shows that sterile injectable drugs can be brought back to the U.S. using modern technology for the benefit of American patients, workers, and their families. The FDA's approval ahead of the goal date shows the agency's commitment to timely approval of drugs that are in critical shortage. Why does preservative-free ketamine matter? After all, ketamine's been used in American hospitals since 1970. It's used primarily for anesthesia and pain control, including in labor and delivery, where it's the only IV anesthetic that minimizes suppression of breathing in the baby. Yet, every ketamine injection product available in the U.S. today contains a preservative, mainly benzethonium chloride or BZT. BZT is there to keep multi-dose glass vials sterile. It does nothing whatsoever for the patient.
The FDA has declined to designate it as generally recognized as safe or GRAS, and under current FDA policy, it cannot be included in new drugs, consumer hand cleansers, wipes, or healthcare surgical hand rubs. Ketamine is one of the last remaining sterile drugs that still contains BZT. We filed a Citizen Petition asking the FDA to remove BZT from ketamine, and the expert toxicology report that accompanies that petition is available for you to read on the public FDA docket. That report documents that patients receiving ketamine at doses routinely used today in hospitals and clinics may be exposed to BZT at levels that exceed the FDA's published maximum daily exposure of 1 milligram. The concern is greatest in critical care and pain infusions, which can run 3-8 days, and in vulnerable patient populations such as newborns, patients with anemia, and patients with impaired kidney function.
For decades, it was widely believed that BZT was required for the long-term stability and sterility of ketamine. We have shown otherwise. We've completed three process validation lots at the approved batch size, and two years of real-time stability data, we're about halfway to our third year, show no less potency or sterility than day 1. Having demonstrated this for ketamine, we're prepared to extend the technology to other sterile injectable products that could enter the market by the end of 2027. Although we remain committed to our innovative roots in treating CNS disease, we believe that the learnings from this product approval can be leveraged to other immediately marketable products that will benefit patients and drive revenue and earnings for our shareholders. What is the market for preservative-free ketamine?
We're going to give you a lot more information about the granularity of that market when we report earnings in a few weeks. At the current price of $5 a vial, which is what's called the MAC price, that's the price hospitals pay en masse, it's a market that approaches $400 million in 2027. That market is growing rapidly as ketamine finds more and more uses. The uses of ketamine in psychiatry have gained a great deal of popular attention. However, psychiatry is really the tip of the iceberg. There's a rapidly increasing use of ketamine at substantially higher doses for pain control indications that were previously treated with opioids. Hospitals are under intense regulatory and public pressure to curtail opioid use, and ketamine is one of the few solutions that can give patients relief from severe pain without opioids.
While the psychiatry uses remain off-label and will require us to obtain new labeling claims in order to secure insurance reimbursement, and in order to promote for those indications, the pain control applications are already reimbursed by insurance. The hospital segment is growing rapidly. In 2025, the demand for ketamine grew 17%. The demand is there. The problem has been supply. What have the buyers told us? As we were completing the ANDA process, we spoke with hospital pharmacists, administrators, health systems, and group purchasing organizations. Their message was consistent. Every GPO, or group purchasing organization, and every pharmacist we spoke with named supply of ketamine as a top concern. Health systems scored supply shortages at a score of 4.6 on a scale of 5. It was their top pain point. Those buyers told us that they will switch for reliable supply and simpler, safer preparation.
We identified no customer allegiance to the current offshore suppliers of ketamine or other sterile injectable products. That brings me to the launch. Our approach is simple. First, assure supply for customers. As we previously announced, we've ordered 5 million vials as launch stock, and Nephron is building that stock now through December. We expect to manufacture in million-vial batches going forward. The ketamine drug ingredient is in hand, and we've manufactured the process validation runs that prove our manufacturing capability. Now that our ANDA is approved, we're opening pre-launch orders as launch supply builds. First shipments will begin once sufficient stock is in place, so that when a hospital commits to us, we can keep that hospital supplied. In a market where every manufacturer is short of ketamine, being in stock is how a new supplier wins share. We're reaching customers through three channels. First, hospitals.
Hospital ketamine purchasing is highly concentrated. About 17% of U.S. hospitals, perhaps 1,200 customers, many of whom are already in national buying groups, buy about 80% of hospital ketamine. Our channel account sales team is in place and focused on those hospitals. The largest accounts will receive account plans and guaranteed supply agreements, while the rest of the market will be served through wholesalers and GPO catalogs, inside sales, and online ordering. Second, trade and GPOs. We have access from day one through Nephron's existing wholesaler and group purchasing organization contracts. McKesson, Cardinal, Cencora carry about 90% of U.S. distribution for ketamine, and Vizient, Premier, and HealthTrust cover about 80% of hospital beds. In parallel, we'll pursue our own contracts. Third, clinics. We've previously shared with you our relationship with Osmind, a medical record vendor focused on interventional psychiatry.
We are partnered with Osmind to bring real-world evidence on ketamine efficacy and depression to the FDA in support of our NRX-100 approval. Together with Osmind, we built a clinic ordering platform to enable affiliated psychiatry clinics to order our product as needed, with one click inside a system that they already use. We are also mapping the broader universe of roughly 8,000 ketamine clinics using claims, electronic health records, and directory data. Our engagement with clinics is limited to the ordering process. We will not be promoting the product off-label. This commercial infrastructure for our ketamine launch is in place. Nephron runs order to cash, including third-party logistics, invoicing, chargeback, and the data feed. IQVIA supports gross to net and government pricing and reporting. ProPharma handles medical information, pharmacovigilance, and promotional review. Here is how we expect the first year to unfold.
Before shipments, we pre-sell, take supply reservations, and offer supply agreements to our top accounts. In the first three months of shipment, we focus on converting the top decile hospitals. In months four through six, we widen to more hospital deciles and health systems, aid group purchasing organizations, and build clinic reorders. In months seven through 12, we deepen our share within each account. What comes next? Preservative-free ketamine is the first step. We plan to add a family of vials, different sizes, different strengths, beginning in 2027. We will be taking delivery of our first new manufacturing line from Germany in Q1 2027, and thank the investors led by B Group who made the manufacturing expansion possible. These timelines are planning assumptions. Each new vial sells to the same account under the same agreements.
The hospital and clinic channel we are building for the preservative-free ketamine is the same channel that will carry NRX-100 if approved. As Brian mentioned, we are not providing guidance today. For those of you who are building models, we know that the ketamine market in the U.S. alone is in the $400 million range, and we will provide substantially more granularity when we announce earnings in a few weeks. Why should this matter to us as Americans? We have talked a great deal about why our product matters to patients, to medical professionals, and families. Let us talk for a minute about why it matters to Americans. According to the Brookings Institution and the US Pharmacopeia, nearly 60% of sterile injectable drugs that treat Americans are manufactured overseas. This year, we have seen supply shocks in the energy sector, even though the United States is a net exporter of energy.
Returning sterile injectable product manufacturing to the United States is not only critical to our nation's security, it has the potential to create tens of thousands of rewarding manufacturing jobs. To summarize, every competing ketamine product contains a preservative, and ours does not. Our product is made in America. It is made at margins that rival the margins of an innovative drug, and it enters the market that has been short of supply for more than eight years. Our launch stock is building, our sales team is in place, and we have distribution access from day one. I want to thank FDA's Office of Generic Drugs for its timely review, thank our partners at Nephron Pharmaceuticals, our regulatory team at Hyman, Phelps & McNamara, our employees who have been at this now for 10 years, and our shareholders for their continuing support. Operator, we are now ready to take questions.
Thank you. Ladies and gentlemen, we will now conduct the question-and-answer session. If you have a question, please press the pound key, followed by one on your touch-tone phone. You will hear a one-tone prompt acknowledging your request. Your question will be pulled in the order they are received. If you would like to decline from the polling process, please press pound. Please ensure you lift the handset if you are using a speakerphone before pressing any keys. One moment, please, for your first question. Your first question comes from Tom Shrader from BTIG . Please go ahead.
Good morning. Congratulations, and a beautiful overview. I am wondering if, in your interactions with the FDA, you got any read on their view of the preservative. Also, similarly, you talked a little bit about copying your vial as a risk, but don't you have IP around the preservative-free form of ketamine? So, how robust is that IP? Then I have a follow-up. Thank you.
Well, to take your question sort of in reverse order, yes, we have a patent filed that's in prosecution around the preservative-free formulation. I would never speculate about the robustness or the defensibility of a patent. It's important to get as much IP as we can. We also have IP around that drug-device combination that represents our Luer lock vial. You can't just go and make that yourself tomorrow and have it be compliant. You saw that we got a lot of scrutiny during the ANDA process from not only the FDA Office of Generic Drugs, but the Center for Devices and Radiological Health. You saw that 2-month delay in the ANDA approval, even though we were well prepared with thousands of pages of detail around that device component.
As I said, it's about 2 millimeters of plastic, but it's got as much documentation behind it as far more complex medical devices, and the FDA takes it very seriously. So, we have IP both around the formulation, but also around the innovative packaging that, for the first time, makes it possible to distribute a sterile injectable product in a blow-fill-seal format.
Got it. Okay. And then the Citizen Petition and the FDA?
The FDA has said a lot of what they think about benzethonium chloride in their public hearings. Those hearings are referenced in the Citizen Petition, in the toxicology report. But the fact that the FDA has put benzethonium chloride clearly in its crosshairs and said, "You can't even put this in a hand cleanser," tells you a lot about what the FDA thinks about that particular quaternary ammonium preservative. And these preservatives have uniformly been driven out of the drug supply. Ketamine was just one of these odd products that was formulated during the Vietnam War, and nobody ever really took a hard look at the formulation since.
I got it. And if I can follow up, we've often felt that the efforts to build the HOPE Network would be greatly helped by unique products, and it looks like you have one now and others in the pipeline. Do you think this is enough, or do you think correctly labeled ketamine is bigger? Or just your thoughts on how this might ripple through to the HOPE side of the business, because now you have a unique product that seems worth distributing.
Well, certainly, although we'll never tell the doctors in the HOPE clinics what medicines to use, we certainly hope that our doctors will want to use our medicines. But if you're looking for the unique opportunity in HOPE, I direct you back to the confidence that the Defense Advanced Research Projects Agency has just placed in our company, in our newly formed NRx Defense subsidiary, which is now a qualified DARPA contractor, and in the role of HOPE Therapeutics. You've got the most prestigious research organization in the U.S. military saying that if our combination approach using transcranial magnetic stimulation and NRX-101 succeeds, as it already has in phase II studies, this could be the standard of care for treating depression in military personnel and first responders. There's been a lot of excitement about psychedelics, but you have not seen that excitement within the mainstream military.
You've not seen that excitement within first responder organizations. I think there's a certain amount of trepidation about psychedelics in those settings. If you're looking for where HOPE gain a unique niche, and the sub-question to that may be, why are we going a little slower than we thought we might when we founded HOPE? We believe that we're on the verge of a short treatment, maybe even as short as one day, that gives patients benefits that previously were not achievable with oral antidepressants, previously were not achievable with ketamine alone, with ketamine nasal spray, and results that exceed anything that's ever been reported for a psychedelic. If your question is, what's the unique opportunity within HOPE? The unique opportunity is to pioneer combination treatments for depression, suicide, PTSD, that work for Americans.
Great. Thanks for the detail and for exploring off-topic subjects. Thank you.
Thank you. The next question comes from Elemer Piros with Lucid Capital Markets. Please go ahead.
Yes. Good morning, Jonathan. You talked about three different channels. How do you envision the distribution or the proportion of revenue coming through these three channels, approximately?
I think that's something that we should reserve for a fireside chat. I'd love to bring our commercial team on with you, and let's really explore it. In terms of priorities, the first priority is to take down the largest hospital buying groups first. The key is assuring supply. This isn't really a fight about pricing. The first priority for hospital buying groups is not about preservative-free. That wasn't on their radar. The first priority is assured supply. They need to know that when an anesthesiologist schedules surgery or schedules a pain control infusion, that the ketamine's going to be in the pharmacy. Right now, you've got U.S. hospitals reaching out to compounding pharmacies to buy ketamine in emergency situations because they can't get it through the legitimate pharmaceutical supply chain. We intend to end that problem.
If we can end that problem, we'll have a great first year.
Yep. Would you discuss pricing at this stage, cost of goods, and how revenue is going to be recognized, and what is going to be the split between you and Nephron when Nephron is involved?
Well, we have a supply agreement with Nephron that provides a highly attractive cost of goods. For today, we'll say that our margins rival the margins that people see with some of the innovative drugs today. By the time you've bought a glass bottle in Asia, washed the bottle, filled the bottle with drug, put a stopper on, crimp cap, got it in the box, got it on a ship, got it through customs, your cost of goods doesn't leave you a whole lot of margin. We think that that's part of the reason for the supply shortage. Anybody that took Econ 101 in college says that suppliers will supply up to their point of indifference. At the current hospital prices, I think we're seeing Keynesian economics play out. All of a sudden, we have an opportunity through a technology shift.
As I said to Tom, some of that is proprietary. Somebody can't go out and start selling a Luer lock vial tomorrow. We have an opportunity through a technology shift to restore the margin to the manufacturing process and make it really worthwhile for ourselves and our shareholders to commit capital to this and expect to have a profitable company.
Right. How large is the sales team that you described, Jonathan, that would be serving the hospital market?
It's certainly in double digits. People are being hired every day, so I don't want to give you a precise number. It's more than adequate to immediately address 80% of the hospital demand.
Okay. My last question is, what do you think the timeline for resolution of your Citizen Petition? Part B to this, how would your pricing power change if it is decided in your favor?
There's no PDUFA clock or GDUFA clock on a Citizen Petition. At the same time, you're seeing an administration that is on the record highly opposed to toxic preservatives. One of the leading voices in the administration on the MAHA side who's been vocal about toxic preservatives is the person who's now awaiting final confirmation as Commissioner of the FDA. There's probably never been a more receptive environment within the Department of Health and Human Services to take these old toxic preservatives out of foods and drugs. I can't tell you what the timing will be. I can tell you that we're meeting with people every week. The election has got people a little bit distracted, but people are going to be back to work next week.
Yes. Thanks for the comprehensive overview.
Well, thank you for believing in us.
Thank you. The next question comes from Patrick Trucchio with H.C. Wainwright. Please go ahead.
Thanks. Good morning, and congrats on the approval. Jonathan, just stepping back, what do you think investors should understand differently about NRx now that you have your first approved product? What would you most like to demonstrate over the next year to establish NRx as a commercial pharmaceutical company?
Well, I think your question contains the answer. What do we want people to think about us? We want people to think that we're not a binary biotech company that's going to live or die on its first approval and then sell that product off to big pharma. We want people to recognize that they're seeing an emerging U.S. pharmaceutical company that's committed to U.S. manufacture of innovative products. Although technically ketamine is a generic product, we're bringing it forward using innovative technology that restores the margin to it and makes it a viable product to be sold aggressively within the U.S. marketplace. I think our investors will increasingly have exposure to the commercial side of the company, to the talent that we've recruited.
Recognize that Dr. Panaccucci spent 25 years at Novartis before building the global footprint for WuXi AppTec before going to BridgeBio and bringing a number of highly innovative products into the marketplace. Mr. Tyson has experience at former CNS-focused commercial companies where sales records were beaten on a regular basis. As I explained to you earlier, we start out with a founding shareholder and board member who was one of the leaders of Teva. I think that now that we've finally demonstrated the ability to get one approval and to get it done in about a third of the time, as the FDA says is average, we started to demonstrate some credibility to be thought of as a pharmaceutical company.
Right. That's helpful. As the ketamine, as the sort of the supply builds over time, what do you believe will be the most durable reason hospitals and clinics choose NRx? How do you turn that initial adoption into a lasting franchise?
All of these sterile injectable products have tenuous supply chains, and the answer is supply. If we can get face-to-face with a hospital purchasing agent and show that we're making these drugs in the U.S., they don't ever have to worry about a container being stuck somewhere between China and Hoboken, New Jersey. If we can demonstrate assured supply, we can win, and the rest is upside. The preservative-free is attractive. That's going to take some education of the market. The blow-fill-seal and needle-free use of the vial is attractive to the professionals who've been in our user tests, and we think that that will drive appreciation of the market. But first and foremost, our customers care about our being able to assure supply.
Yep. That's helpful. You described an opportunity to extend this manufacturing approach beyond ketamine. I'm wondering how you would decide which opportunities to pursue, and how could it sort of relate back to the core CNS programs?
The additional sterile injectable drugs that we add to this program may not be CNS-focused. We'll be looking at where is the greatest market need, where is our ability to serve a drug shortage market with U.S.-manufactured goods and assured supply, and the revenues from that will certainly enable us to do more and more innovative work on the CNS side. That's kind of what you saw happen at Teva. You had a very successful generics organization that basically provided the capital that was needed to market the first drug for multiple sclerosis. We didn't found the company ever expecting to get into the sterile drug marketplace.
That happened because FDA surprised us and said, "Hey, guys, you got to get a label on ketamine if you're going to use it to treat depression." We said, "Well, if we're going to sell ketamine, we better sell ketamine to a much broader marketplace than the psychiatry market, because otherwise, it's not financially feasible." We made that bet. The B Group and other investors got behind us, and at least today, it feels like that bet is paying off.
Yep. Terrific. Thank you so much.
Thank you. The next question is from Ed Woo from Ascendiant Capital. Please go ahead.
Yeah. Congratulations on the approval. As you begin to roll out into the U.S. market, is there any opportunity in international for you to take your expertise and to apply it elsewhere?
Are you asking can we sell this drug into Europe? Can we sell this drug into the APAC region?
Yeah, or North America. Canada.
Oh, yeah. But remember, the Canadian market is not all that large. I think as we look across the borders, there is extensive opportunity because pharmaceutical glass continues to get more expensive. As labor costs in other markets rise, the labor intensiveness of glass bottling continues to get more expensive. So, you are going to see more and more suppliers exiting the market for these old sterile products, and more opportunity for us to become a net exporter of sterile injectable drugs.
Great. Thanks for answering my questions, and I wish you guys good luck. Thank you.
Thank you.
Well, thank you. We've been on this for 45 minutes. It's been wonderful to have a chance to catch up with you. We're going to be reporting earnings in a few weeks, and I'm sure we'll see a number of you back again. If you have things that you'd like us to address in that earnings call, please let Brian know. Thank you, and have a great day.
Thank you.
Thanks, Jonathan.
Ladies and gentlemen, this concludes the conference call for today. Thank you for your participation. You may now disconnect your line.