Geron (GERN) Earnings Call zu Q3 2026: RYTELO-Wachstum und gesenkte Ausgabenprognose

Die Geron Corporation (NASDAQ: GERN) berichtete im dritten Quartal 2026 über ein anhaltendes RYTELO-Wachstum und senkte gleichzeitig ihren Ausblick für die Betriebsausgaben des Gesamtjahres. Zudem stellte das Unternehmen die Phase-III-Studie IMPACT MF ein, nachdem ein unabhängiges Komitee festgestellt hatte, dass das Erreichen des primären Endpunkts unwahrscheinlich ist.

Wichtigste Erkenntnisse

• Der Nettoprodukterlös im dritten Quartal 2026 erreichte 60,1 Mio. US-Dollar, was einem Anstieg von 27 % gegenüber dem Vorjahr von 47,2 Mio. US-Dollar und 5 % gegenüber dem Vorquartal entspricht.
• Die Nachfrage nach RYTELO stieg im Vergleich zum Vorquartal um 10 %, was das vierte Quartal in Folge mit Nachfragewachstum für das Produkt markiert.
• Die Anzahl der verschreibenden Einrichtungen wuchs im Laufe des Quartals um 8 %, womit die Reichweite von RYTELO seit der Markteinführung auf mehr als 1.700 Einrichtungen stieg, wobei das Wachstum hauptsächlich von niedergelassenen Praxen angetrieben wurde.
• Geron bestätigte die Prognose für den RYTELO-Nettoprodukterlös für 2026 von 220 Mio. bis 240 Mio. US-Dollar und erwartet Ergebnisse am mittleren bis oberen Ende dieser Spanne.
• Die Prognose für die Betriebsausgaben des Gesamtjahres wurde gesenkt auf 220 Mio. bis 230 Mio. US-Dollar (zuvor 230 Mio. bis 240 Mio. US-Dollar).
• Die Phase-III-Studie IMPACT MF wurde eingestellt, da das Erreichen des Endpunkts für das Gesamtüberleben unwahrscheinlich war. Das Management erklärte, dass keine neuen Sicherheitssignale das bekannte Sicherheitsprofil von Imetelstat verändert hätten.

Wichtigste Finanzdaten

Das Management erklärte zudem, dass die Betriebsausgaben im bisherigen Jahresverlauf um 9 % gegenüber dem Vorjahreszeitraum gesunken sind.

Geschäfts- und operative Entwicklung

Die kommerzielle Dynamik von RYTELO blieb der zentrale Schwerpunkt der Telefonkonferenz von Geron zu den Ergebnissen des dritten Quartals 2026. Die Nachfrage stieg im Vergleich zum Vorquartal um 10 %, während die Zahl der verschreibenden Einrichtungen um 8 % zulegte. Das Management führte einen Großteil dieser Expansion auf niedergelassene Onkologiepraxen zurück, die es als Schlüsselquelle für eine langfristige Akzeptanz ansieht.

Geron beabsichtigt, die weitere Marktpräsenz durch gezielte direkte und indirekte Maßnahmen zu unterstützen. Dabei wird die klinische Wirksamkeit von RYTELO bei myelodysplastischen Syndromen mit geringerem Risiko in der Zweitlinie hervorgehoben und Fachärzte für Hämatologie und Onkologie werden über Dosierung und Zytopenie-Management informiert.

Das Unternehmen hat zudem mit der phasenweisen kommerziellen Einführung in Europa begonnen. In Deutschland soll das Produkt bis Ende 2026 kommerziell verfügbar sein, Frankreich soll 2027 folgen. Laut Management soll das gestaffelte Modell die Preiskontrolle wahren, anfängliche Infrastrukturinvestitionen begrenzen und die Flexibilität für potenzielle Partnerschaften aufrechterhalten.

Geron merkte an, dass die Marktchancen in Europa durch den Orphan-Drug-Status von RYTELO, ein Einzelindikationsprofil und Prüfarzterfahrungen aus der überwiegend europäischen IMerge-Studie unterstützt werden. Das Management erklärte außerdem, dass hypomethylierende Substanzen in Europa weniger etabliert sind als in den USA.

Prognose des Managements

Geron bekräftigte seine Prognose für den RYTELO-Nettoprodukterlös für 2026 von 220 Mio. bis 240 Mio. US-Dollar. Das Management erwartet auf der Grundlage des anhaltenden sequenziellen Wachstums einen Umsatz am mittleren bis oberen Ende der Spanne.

Das Unternehmen senkte seine Prognose für die Gesamtbetriebsausgaben 2026 auf 220 Mio. bis 230 Mio. US-Dollar, verglichen mit der bisherigen Spanne von 230 Mio. bis 240 Mio. US-Dollar. Die Anpassung spiegelt geringere Personalkosten und eine anhaltende operative Disziplin wider, während Investitionen in RYTELO, Herstellungsaktivitäten und klinische Verpflichtungen nach der Zulassung aufrechterhalten werden.

Für den Rest des Jahres 2026 erwartet Geron Brutto-Netto-Abzüge im niedrigen bis mittleren 20-Prozent-Bereich. Das Management rechnet für 2026 aufgrund von Aktivitäten zur Abwicklung der Studien nicht mit einer erheblichen Reduzierung der Ausgaben für das Myelofibrose-Programm.

Blickt man über das Jahr 2026 hinaus, erklärte das Management, dass die Ausgaben steigen könnten, wenn die europäische Strategie reift und die klinischen Verpflichtungen nach der Zulassung voranschreiten.

Risiken und wesentliche Beobachtungspunkte

Das unabhängige Datenüberwachungskomitee empfahl die Einstellung der Phase-III-Studie IMPACT MF, da es unwahrscheinlich war, dass Imetelstat den primären Endpunkt des Gesamtüberlebens bei rezidivierter oder refraktärer Myelofibrose nach einer Behandlung mit JAK-Inhibitoren erreichen würde.

Geron plant, die Studiendaten zu entblinden, zu analysieren und die Ergebnisse auf einer künftigen medizinischen Fachtagung vorzulegen. Obwohl das Management keine Sicherheitserkenntnisse meldete, die das bekannte Profil von Imetelstat verändern würden, entfällt durch die gescheiterte Wirksamkeitsbewertung eine potenzielle Entwicklungschance bei Myelofibrose.

Auch die Kommerzialisierung in Europa bleibt gestaffelt. Verfügbarkeit, Fortschritte bei der Kostenerstattung und Ausgaben werden je nach Markt variieren, während das Unternehmen weiterhin Partnerschaftsoptionen prüft.

Highlights der Fragerunde mit den Analysten

Künftige Ausgaben: Das Management erklärte, dass die Kapitalallokation diszipliniert bleiben werde, erwartet jedoch höhere Ausgaben im Zuge der Entwicklung der Kommerzialisierung in Europa und des Fortschritts der Studien nach der Zulassung. Von den Abwicklungskosten für IMPACT MF werden im Jahr 2026 keine nennenswerten Einsparungen erwartet.

Wachstumspfad von RYTELO: Das Management nannte keinen spezifischen Wendepunkt bei der Markteinführung. Stattdessen erwartet es ein konsistentes Wachstum gegenüber dem Vorquartal, unterstützt durch eine höhere Durchdringung des niedergelassenen Bereichs und ein Potenzial von Tausenden zusätzlichen geeigneten Patienten.

Unternehmensentwicklungsstrategie: Geron sucht nach Vermögenswerten, die die bestehende Vertriebsorganisation in den USA nutzen können. Das Management identifizierte Produkte für die niedergelassene Hämatologie oder Onkologie als Hauptziel und erklärte, dass Vermögenswerte mit einem potenziellen Spitzenumsatz von mehreren Hundert Millionen US-Dollar geeignet sein könnten. Das Unternehmen beschrieb seinen bevorzugten Ansatz als eine selektive „Perlenschnur-Strategie“.

Chancen in Europa: Das Management schätzte, dass es in Europa mindestens eine vergleichbare Anzahl geeigneter Zweitlinienpatienten gibt wie die für die USA genannten rund 8.000. Deutschland wurde als erster Markt ausgewählt, da das Management dort einen tragfähigen Weg zur Kostenerstattung und eine Preisgestaltung sieht, die die Innovation des Produkts widerspiegeln kann.

Vollständiges Transkript der Telefonkonferenz

Vollständiges Transkript der Telefonkonferenz

Ausführungen des Managements

Operator

Hello, and welcome to the Geron Corporation Third Quarter 2026 Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the call over to Dawn Schottlandt, SVP, Investor Relations and Corporate Affairs. You may begin.

Dawn Schottlandt

Good morning, everyone. Welcome to the Geron Corporation Third Quarter 2026 Earnings Conference Call. Before we begin, please note that during the course of presentation and question-and-answer session, we will be making forward-looking statements regarding future events, performance, plans, expectations and other projections, including those related to our 2026 financial guidance, our current RYTELO commercialization strategy and related opportunities in the U.S. and the EU, the therapy potential of RYTELO and other anticipated clinical and commercial events and related time lines, the sufficiency of our financial resources and other statements that are not historical fact, which, of course, involve risks and uncertainties that could cause actual events performance and results to differ materially from those contained in these forward-looking statements. Therefore, I refer you to the risks and uncertainties described in today's earnings release and other the heading Risk Factors in Geron's most recent periodic report filed with the SEC, which identify important factors that could cause actual results to differ materially from those contained in these forward-looking statements and future updates to Geron's risks and uncertainties, disclosures, including in its upcoming quarterly report on Form 10-Q.

Geron undertakes no duty or obligation to update its forward-looking statements.

Joining me on today's call are several members of Geron's management team; Harout Semerjian, Chief Executive Officer; Ahmed ElNawawi, our Chief Commercial Officer.

With that, I'll turn the call over to Harout to discuss Geron's progress in the third quarter.

Harout Semerjian

Thank you, Dawn, and good morning, everyone. We continue to execute our strategy to build a leading hematology company. We're delivering consistent retail demand growth, reinforcing our confidence in the low-risk MDS U.S. commercial opportunity and RYTELO's growth trajectory over the next several years. We also initiated a gated commercial launch in targeted European markets that gives us the optionality to scale up RYTELO's availability through partnerships.

Last week, we announced the discontinuation of the IMPACT MF trial evaluating imetelstat in relapsed and refractory myelofibrosis following a recommendation by the independent DMC. We believe this is the right course of action for patients and for Geron.

In the third quarter, we continued to see increased prescribing from community practices leading to a quarter-over-quarter demand growth of 10% and net revenue growth of 5% or $60.1 million. This represents a 27% increase in net revenue year-over-year. This performance keeps us on track to achieve the mid- to high end of our full year 2026 net revenue guidance range of $220 million to $240 million and reinforces our confidence that RYTELO has a long growth runway in the U.S.

This year, we started executing our ex-U.S. go-to-market commercial strategy, focused on addressing unmet patient needs and broadening access to RYTELO while prioritizing U.S. price integrity. Recent developments, including the exclusion of orphan drugs like RYTELO from the CMS globe model gives us the opportunity to serve more patients globally. We initiated a gated commercial launch to make RYTELO available in targeted European markets, beginning with Germany, where RYTELO is expected to be commercially available by the end of this year. In Europe, our approach enables us to retain strategic control of pricing without having to establish full infrastructure in each market or commit to a large upfront investment. This hybrid model also allows us to remain flexible and open to partnership opportunities.

To support our global reach, we recently increased our engagement and presentations at multiple international medical meetings, and we're encouraged by the interest from hematologists in key markets. We will continue to explore opportunities in other geographies where we believe we can help address the significant unmet need of low-risk MDS patients. As we continue to strengthen our operations, another area of focus for us is financial discipline where our investments are intentional and targeted. Our operating expenses were down 9% year-to-date compared to the prior year reflecting our continued focus on operational efficiency. This discipline is enabling us to update our full year 2026 total operating expense guidance range from $220 million to $230 million. With $339 million of cash on hand, we have a strong balance sheet to fund our current operations which gives us flexibility to pursue business development opportunities.

With that, I'll turn it over to ElNawawi to provide more detail on RYTELO's commercial performance and our execution.

Ahmed ElNawawi

Thank you, Harout. We are pleased to report our fourth consecutive quarter of demand growth for RYTELO, reinforcing the need for this drug and its potential long-term value as a preferred treatment and second-line low-risk MDS. In the third quarter, we achieved a 10% demand growth for RYTELO compared to the second quarter of this year, an 8% increase in prescribing accounts, predominantly from community practices expanding our footprint to more than 1,700 accounts since launch. With first and second-line patient starts on a rolling 12-month basis at 36%.

We believe that RYTELO has the potential to deliver consistent quarter-over-quarter growth for years to come, driven in large part by continued adoption in the community setting where there are still thousands of patients that can benefit from RYTELO. Our focus is on accelerating that adoption through targeted personal and nonpersonal engagements that reinforce RYTELO's differentiated clinical efficacy in second line low-risk MDS patients. while continuously educating hemoncs on dosing and management of cytopenias.

RYTELO's unique mode of action as a first-in-class telomeres inhibitor. It's broad label and position in NCCN guideline provide a strong foundation to drive durable long-term growth.

Turning to our efforts in Europe. We've taken a gated operational approach where we drive regulatory engagement and local reimbursement process to ensure RTYELO reaches the appropriate patients at a price that reflects unique value. Our model allows us to broaden RYTELO's access with a staged upfront investment while preserving flexibility for the future. We have already initiated our launch in Europe and plan to make RYTELO commercially available in Germany by the end of the year with trends to follow in 2027.

We are encouraged by the interest we're seeing across markets, supported by investigated experience with imetelstat and the significant unmet need in low-risk MDS. I now turn it over to Joe to discuss our medical and scientific engagement efforts.

Joseph Eid

Thanks, ElNawawi. Last week, we announced our decision to discontinue the Phase III IMPACT MF trial evaluating imetelstat and JAK inhibitor relapsed/refractory myelofibrosis. This decision was based on the recommendation from the independent data monitoring committee informing us that the trial was unlikely to meet its primary endpoint of overall survival. Importantly, there were no safety signals observed in the trial that changed the known safety profile of imetelstat. We are committed to unblinding the data, conducting a detailed analysis of this rich data set and sharing findings at an upcoming medical meeting that may help inform future research. We are deeply grateful to the patients and families as well as the investigators and clinical teams whose dedication made this research possible.

Turning to low-risk MDS. This quarter, we presented at leading hematology meetings, both global and regional further communicating the growing body of evidence supporting RYTELO's differentiated profile, including evidence of disease-modifying activity. Just as importantly, these meetings created meaningful opportunities to engage directly with the medical community exchange insights and deepen scientific dialogue around the evolving treatment of low-risk MDS.

At SOHO, we continue to build strong momentum through impactful data presentations, sponsored dedication and broad power engagement powered by a coordinated full team approach. Our low-risk MDS real-world evidence poster showed meaningful hemoglobin improvement with imetelstat despite short treatment duration and later line news in U.S. community oncology practice in the immediate post-launch period. This marked the second real-world evidence presentation this year adding to the growing body of evidence that reinforces findings from our Phase III IMERSE trial and the safety, efficacy and tolerability profile of RYTELO.

Additional data presented at the 88th Annual Meeting of the Japanese Society of Hematology and the 2026 Annual Meeting of the German, Austrian and Swiss Societies for hematology and medical oncology further highlighted the durable clinical outcomes observed within imetelstat and expanded the growing body of evidence supporting its differentiated profile. Across the presentations, Phase III IMerge findings and real-world experience reinforce the durability and clinical relevance of treatment outcomes, including findings suggesting that treatment emergent cytopenia may reflect an on-target effect associated with meaningful clinical outcomes, such as hemoglobin improvement and transfusion independence in low-risk MDS.

Importantly, the presentations also demonstrated growing scientific interest and investigator experience with imetelstat outside the U.S. as we continue to deepen engagement with the global hematology community. Beyond congress presentations, we continue to strengthen the scientific foundation of RYTELO through 2 manuscripts published in peer-reviewed journals, further expanding the body of evidence supporting imetelstat's role and low-risk MDS and its potential to address significant unmet need.

Looking ahead, the 68th ASH Annual Meeting in December will provide another opportunity to build on this body of evidence with new data across low-risk MDS and other hematological diseases that will further inform our understanding of RYTELO's clinical potential. Our 6 accepted abstracts at ASH reinforce the clinical and biological evidence of RYTELO and we look forward to sharing additional details later today. Our progress has been recognized beyond the medical community. We are honored to have been nominated for the pre Gallium USA Award for best product for orphan or rare diseases. This recognition represents decades of pioneering work in telomerase inhibition and most importantly, a sustained commitment to addressing significant unmet need for people living with low-risk MDS. It is a meaningful acknowledgment of the science behind RYTELO and the potential to translate that science into better outcomes for patients.

I'll now hand it over to Michelle to walk through the financials.

Michelle Robertson

Thank you, Joe, and good morning, everyone. For more detailed results from the third quarter, please refer to the press release we issued this morning, which is available on our website. Our third quarter financial results highlight the progress we are making on our commercial strategy and operational excellence. We are in a strong financial position with a balance sheet that enables targeted and disciplined investments into further growth opportunities, including business development.

In the third quarter, total net product revenue for the 3 months ended September 30, 2026, was $60.1 million compared to $47.2 million in Q3 of 2025. Gross to net deductions decreased to 19.3% for the 3 months ended September 30, 2026 compared to 21.6% for the same period in 2025. For the remainder of 2026, we continue to expect gross to net to be in the low to mid-20s. Research and development expenses for the 3 months ended September 30, 2026, were $12.7 million compared to $21.1 million in expenses for the same period in 2025. The decrease in research and development expenses was a result of lower headcount costs from the workforce reduction in December 2025 and lower clinical chemistry manufacturing and control costs. For the remainder of 2026, we expect continued investment in CMC and our clinical post-marketing commitments, offset by lower employee costs.

Due to wind-down activities, we do not expect any significant decrease in spending on our MF program in 2026. Selling, general and administrative expenses for the 3 months ended September 30, 2026, were $35.7 million compared to $39 million for the same period in 2025. This decrease was primarily due to lower general and administrative personnel-related expenses as a result of the workforce reduction in December 2025. Total operating expenses, excluding COGS, for the 3 months ended September 30, 2026 were $48.3 million compared to $60.1 million for the same period in 2025. As of September 30, 2026, we had approximately $339 million in cash, cash equivalents, restricted cash and marketable securities compared to $327 million as of June 30, 2026. We are committed to maintaining our financial discipline and are well positioned to fund growth from our current operations.

We are reiterating our 2026 RYTELO net revenue guidance with the expectation we will come in at the mid- to high end of the $220 million to $240 million range, reflecting consistent quarter-over-quarter net revenue growth throughout the year. We are lowering our total operating expense guidance from $230 million to $240 million to the range of $220 million to $230 million. This reduction reflects our ability to drive continued operational excellence, while also making strategic investments into RYTELO and future growth opportunities. With $339 million in cash, we are well positioned to execute on our financial and strategic priorities through the remainder of the year.

With that, I'll turn the call back to Harout for closing remarks.

Harout Semerjian

Thanks, Michelle. RYTELO has grown for 4 consecutive quarters, placing us on track to achieve our 2026 net revenue guidance and maximize our long-term growth potential. Beyond RYTELO, our financial strength gives us the flexibility to explore business development opportunities to build a leading hematology company.

Operator, we're now ready to start the Q&A session.

Operator

[Operator Instructions] And our first question comes from Tara Bancroft of TD Cowen.

Fragen und Antworten

Tara Bancroft

So it's great to see the reduced OpEx guidance this year. It all makes sense. But I'm wondering how we should think about OpEx expectations really going forward, especially with the Phase III not factored in. If there are any savings from that? Maybe you could tell us also what you plan to put that towards in terms of future pipeline or any thoughts regarding that, that would be great.

Harout Semerjian

Yes. Thank you, Tara. Maybe that's a question Michelle can address.

Michelle Robertson

Yes. Thanks, Tara. So yes, we reduced our OpEx for 2026. What I would say about the go-forward investments, we'll continue to be very disciplined in our capital allocation. You will see some increases next year as our Europe strategy matures as well as the post-marketing commitment in clinical trials. So although the remainder of the OpEx will be steady, we will see some increases for those 2 material later.

Operator

And our next question comes from Gil Blum of Needham.

Gil Blum

Congrats on the progress here. So definitely seeing consistent growth quarter-over-quarter kind of in the low -- in the single digits. What do you think could cause a rate change or change in the rate of uptake that would be more of an acceleration? And is this something we should expect? Or should we continue to see this kind of like consistent growth over time? And I have a follow-up.

Harout Semerjian

Thank you, Gil. As we have communicated multiple quarters ago, the way we look at RYTELO's growth, if we do things well, is it will deliver consistent growth quarter-over-quarter. And we're very pleased today to announce the fourth quarter of that strategy in action where we continue every quarter to increase demand to increase sales, to increase penetration in the first-line, second-line market patient segment and to reduce OpEx. And we believe that's a winning strategy on the long term. That's kind of where we are, Gil. I know sometimes people ask us -- what is the exact inflection point. And we continue to maintain this is a growth quarter-over-quarter if we do this well. And we do believe that there are thousands of more patients who can benefit from RYTELO for many years to go to come. That's why we do see the long-term perspective of RYTELO growth are quite good. But the curve of the growth is really what we are pleased with, and we think that this is something that we can continue to grow. I don't hope that answers your question. And I think you had a follow-up.

Gil Blum

Yes. That was helpful. And just given the financial discipline here and a pretty meaningful cash position. You guys mentioned BD a couple of times. Is there a specific character of product that you're looking for? Is this likely an [indiscernible] asset? I mean, any guidelines that you can give us to what you're thinking of?

Harout Semerjian

Sure. Yes. No, I mean so if you step back and look at where we are as a company, we have a very healthy base business in RYTELO in the U.S. that's growing every quarter and we reiterated our mid- to high level of our guidance of $230 million to $240 million, right? So that's from a U.S. perspective. We're also today, very excited to share that we're surgically -- the work that has happened ex-U.S. especially in Europe over the last several months, especially on the pricing side, puts us in a very good position to actually make the RYTELO available in the commercial setting, starting with Germany before end of the year and then rolling into other countries such as France next year while maintaining optionality of partnership, which is really a win-win strategy that doesn't put us in a situation where we have to shell out a lot upfront. We do it in a very, very specific way.

Now coming to BD, this also allows us -- especially now with the MF overhang behind us. Obviously, we're going to be looking into that very rich database and truly understand what are some of the trends in myelofibrosis. But given that, that's really -- it never was really part of our base strategy, at least not in the last couple of years, it was always treated as an upside. But now we're in a good situation to really pursue BD opportunities. So we have a winning team in the U.S. from a commercialization perspective. what would make the most sense is really to bring in another asset to put it in the bag of that team that's shown its ability to grow RYTELO and to get into other hematology oncology assets. As you know, 80% of this business is actually in the community. So it can really be any asset in hematology or oncology that is predominantly a community disease that as a first kind of bullseye.

And then we will keep the right to be opportunistic beyond that given that our approach of being very selective, targeted where we invest and really drive value through that has now been taking life over the last couple of -- over the last 4 quarters, I would say, and we do believe we can do that with other assets. We're not competing with a Pfizer or Novartis with needing assets with $2 billion, $3 billion peak sales, assets that have a few hundred million potential peak sales is plenty for us and then we can pursue a string of pearls approach with that over the next several years. So that's what we're excited about, not just for the base business, but also where we can go with BD. Does that help answer the question, Gil?

Gil Blum

Yes. Very helpful.

Operator

[Operator Instructions] Our next question comes from Stephen Willey of Stifel.

Stephen Willey

Maybe just a quick housekeeping question for Michelle. Any notable changes to inventory during the quarter? And then I just have a follow-up.

Michelle Robertson

No, you just remain within our 2% to 4% guidance that we saw share in the half 2 to 4 weeks.

Stephen Willey

And then just curious about how you're thinking about the opportunity here in Europe. I know that you're initially entering kind of a very limited number of markets. But can you maybe speak to any differences in how the disease might be managed there just relative to the U.S.? I guess when I look at REBLOZYL, they're generating, I think, less than 20% of their sales ex U.S. I'm sure is is partially pricing-based, but would perhaps suggest some differences in terms of how the disease is managed.

Harout Semerjian

Sure. Maybe I'll start off and then ElNawawi can supplement as well. Look, I mean, from a patient perspective, it's really the same size of number of patients that we have in the U.S., in the U.S. have said about 8,000 patients would be eligible for that second line patient population. And then as you know, European average age is even older. So it's at least that number of patients from a macro perspective overall. The reason obviously, we're choosing Germany to go with. I mean that is the country where you have a meaningful path for innovation in a healthy pricing point in line with the innovation that we can bring. ElNawawi, do you want to add on top of that additional reasons to believe?

Ahmed ElNawawi

Sure. And a couple of points maybe Steve, you referred to even BMS. They have gone through several price iterations because of their other label and multiple indications. We are a single indication drug with a outran designation, which does give us high showing, especially in Germany reimbursement perspective, plus the market is not as diversified in terms of payment options in Europe compared to the U.S., where in the U.S., we see a much higher use of HMA in second and third line, which is not reflect what the European market, so we see a bit of differences and by vote.

Harout Semerjian

Yes. And just to be also addressed, the reversal point you made, Steve. I mean that is you -- probably know that, that in most European markets, it is restricted to Rh positive. And I mean, typically larger pharma has to think about the portfolio overall, especially protecting larger products like their PD-1s. We don't have that interest, so we have a label that we can pursue especially in Rh negative patient population, Wilson designation. HMAs are not as entrenched in Europe, older population. And as you know, the clinical trial we had, IMERGE, was predominantly European. So there's significant advocacy as well from the medical community wanting to see RYTELO available for that patient.

Stephen Willey

Congratulations on achieving profitability.

Operator

Thank you. I show no further questions at this time. I'd like to turn it back to Harout Semerjian for closing remarks.

Harout Semerjian

Thank you to everyone joining our call today. We look forward to updating you on the progress in the next several quarters. Thank you.

Operator

This concludes today's conference call. Thank you for participating, and you may now disconnect.