제론(GERN) 2026년 3분기 실적 발표 콘퍼런스 콜: 라이텔로 성장과 비용 가이던스 하향
제론 코퍼레이션(NASDAQ: GERN)은 2026년 3분기 라이텔로(RYTELO)의 순제품 매출이 전년 동기 대비 27% 증가한 6,010만 달러를 기록하며 4분기 연속 수요 성장을 보였다고 발표했습니다. 처방 계정 수는 8% 증가하여 1,700개 이상으로 확대되었습니다.
회사는 2026년 라이텔로 순매출 가이던스를 2억 2,000만 달러~2억 4,000만 달러로 유지하며 중상단에 도달할 것으로 예상하고 있습니다. 또한 영업비용 효율화를 반영해 연간 영업비용 가이던스를 기존 2억 3,000만 달러~2억 4,000만 달러에서 2억 2,000만 달러~2억 3,000만 달러로 하향 조정했습니다.
한편, 독립위원회 권고에 따라 이메텔스타트의 임상 3상 IMPACT MF 시험은 1차 평가변수인 전체 생존기간을 충족하기 어려울 것으로 판단되어 중단되었으나, 새로운 안전성 신호는 관찰되지 않았습니다.
유럽 시장의 경우, 독일을 시작으로 2026년 말까지 단계별 상업 출시에 착수할 예정이며, 파트너십을 위한 유연성을 유지할 계획입니다.
제론 코퍼레이션(NASDAQ: GERN)이 연간 영업비용 전망을 하향 조정하는 가운데 2026년 3분기 라이텔로(RYTELO)의 지속적인 매출 성장을 기록했다고 발표했습니다. 또한 이 회사는 독립위원회가 1차 평가변수를 충족하기 어려울 것으로 판단함에 따라 임상 3상 IMPACT MF 시험을 중단했습니다.
핵심 요약
- 2026년 3분기 순제품 매출은 6,010만 달러를 기록해 4,720만 달러에서 전년 동기 대비 27% 및 전분기 대비 5% 증가했습니다.
- 라이텔로 수요는 전분기 대비 10% 증가하여, 4분기 연속 수요 성장을 기록했습니다.
- 처방 계정 수는 해당 분기 동안 8% 증가하여, 출시 이후 라이텔로의 처방 계정 수가 1,700개 이상으로 확대되었으며, 이러한 성장은 주로 지역 병의원이 견인했습니다.
- 제론은 2026년 라이텔로 순매출 가이던스를 2억 2,000만 달러~2억 4,000만 달러로 재확인했으며, 실적이 해당 범위의 중상단에 달할 것으로 예상합니다.
- 연간 영업비용 가이던스는 기존 2억 3,000만 달러~2억 4,000만 달러에서 2억 2,000만 달러~2억 3,000만 달러로 하향 조정되었습니다.
- 임상 3상 IMPACT MF 시험은 전체 생존기간(overall survival) 평가변수를 충족하기 어려울 것으로 판단되어 중단되었습니다. 경영진은 이메텔스타트(imetelstat)의 기존 안전성 프로필을 변경할 만한 새로운 안전성 신호는 발견되지 않았다고 밝혔습니다.
주요 재무 데이터
| 지표 | 2026년 3분기 | 2025년 3분기 | 변동 또는 배경 |
|---|---|---|---|
| 순제품 매출 | 6,010만 달러 | 4,720만 달러 | 전년 동기 대비 27% 증가, 전분기 대비 5% 증가 |
| 매출 차감액(Gross-to-net deductions) | 19.3% | 21.6% | 전년 동기 대비 감소 |
| 연구개발(R&D) 비용 | 1,270만 달러 | 2,110만 달러 | 인원 감소 및 임상, 화학·제조·품질관리(CMC) 비용 감소 반영 |
| 판매비와 관리비(SG&A) | 3,570만 달러 | 3,900만 달러 | 2025년 12월 인력 감축에 따른 인적 자원 관련 비용 감소 |
| 매출원가 제외 총 영업비용 | 4,830만 달러 | 6,010만 달러 | 전년 동기 대비 감소 |
| 현금, 현금성 자산, 제한된 현금 및 매도가능증권 | 3억 3,900만 달러 | — | 2026년 6월 30일 기준 3억 2,700만 달러 대비 증가 |
경영진은 또한 연초 대비 누적 영업비용이 전년 동기 대비 9% 감소했다고 밝혔습니다.
사업 및 영업 실적
라이텔로의 상업적 성장 모멘텀은 제론의 2026년 3분기 실적 발표에서 핵심 주제로 다뤄졌습니다. 직전 분기 대비 수요는 10% 증가했으며, 처방 계정 수는 8% 늘었습니다. 경영진은 이러한 확장의 대부분을 지역 종양학 병의원 덕분으로 돌렸으며, 이를 장기적 채택의 핵심 원천으로 보고 있습니다.
제론은 2차 저위험 골수이형성증후군에서 라이텔로의 임상적 유효성을 강조하고 혈액종양내과 의료진을 대상으로 용량 및 혈구감소증 관리 교육을 실시함으로써, 맞춤형 대면 및 비대면 참여를 통해 처방 확대를 지속적으로 지원할 계획입니다.
또한 이 회사는 단계별 유럽 상업 출시에 착수했습니다. 독일은 2026년 말까지 상용화될 예정이며, 프랑스는 2027년에 뒤따를 계획입니다. 경영진은 이러한 단계적 모델이 가격 결정권 유지, 초기 인프라 투자 제한, 잠재적 파트너십을 위한 유연성 확보를 목적으로 한다고 설명했습니다.
제론은 라이텔로의 희귀의약품 지정, 단일 적응증 프로필, 그리고 주로 유럽에서 진행된 IMerge 임상시험을 통한 연구자 경험이 유럽에서의 기회를 뒷받침한다고 언급했습니다. 또한 경영진은 유럽에서는 미국보다 저메틸화제(HMA)의 정착도가 낮다고 덧붙였습니다.
경영진 가이던스
제론은 2026년 라이텔로 순매출 가이던스를 2억 2,000만 달러~2억 4,000만 달러로 유지했습니다. 경영진은 지속적인 분기별 성장에 힘입어 매출이 해당 범위의 중상단에서 마감될 것으로 예상합니다.
회사는 2026년 총 영업비용 가이던스를 기존 2억 3,000만 달러~2억 4,000만 달러에서 2억 2,000만 달러~2억 3,000만 달러로 줄였습니다. 이러한 수정은 라이텔로, 제조 활동 및 시판 후 임상 약속에 대한 투자를 보존하는 한편, 직원 관련 비용 절감과 지속적인 운영 규율을 반영합니다.
2026년 남은 기간 동안 제론은 매출 차감액이 20%대 초중반 수준일 것으로 예상합니다. 경영진은 임상 종료 정리 활동으로 인해 2026년 동안 골수섬유증 프로그램 지출이 크게 줄어들지는 않을 것으로 보고 있습니다.
2026년 이후를 바라볼 때 경영진은 유럽 전략이 본격화되고 시판 후 임상 약속이 진행됨에 따라 비용이 증가할 수 있다고 말했습니다.
위험 요인 및 주요 주시 영역
독립 데이터 모니터링 위원회는 JAK 억제제 치료 후 재발성 또는 불응성 골수섬유증 환자에서 이메텔스타트가 1차 평가변수인 전체 생존기간을 충족하기 어려울 것으로 보임에 따라 임상 3상 IMPACT MF 시험의 중단을 권고했습니다.
제론은 임상 데이터를 맹검 해제 및 분석하여 향후 학술대회에서 결과를 발표할 계획입니다. 경영진은 이메텔스타트의 기존 프로필을 변경할 만한 안전성 결과는 보고되지 않았다고 밝혔으나, 유효성 평가 실패로 인해 골수섬유증 분야에서의 잠재적 개발 기회는 사라지게 되었습니다.
유럽 상업화 또한 단계적으로 진행될 예정입니다. 제품 공급, 약가 수재(보험 등재) 진행 상황 및 지출은 시장별로 다를 것이며, 회사는 파트너십 옵션을 계속 검토 중입니다.
애널리스트 Q&A 주요 내용
향후 지출: 경영진은 자본 배분이 엄격하게 이루어질 것이라면서도, 유럽 상업화가 진전되고 시판 후 임상이 진행됨에 따라 지출이 늘어날 것으로 예상했습니다. IMPACT MF 정리 비용으로 인해 2026년 동안 유의미한 비용 절감 효과가 나타나지는 않을 것으로 보입니다.
라이텔로 성장 궤적: 경영진은 특정 채택 변곡점을 지목하지 않았습니다. 대신 지역 병의원 침투 확대와 수천 명의 추가 적격 환자군에 힘입어 지속적인 분기별 성장을 기대하고 있습니다.
사업 개발 전략: 제론은 기존 미국 상업화 조직을 활용할 수 있는 자산을 모색하고 있습니다. 경영진은 지역 병원 중심의 혈액학 또는 종양학 제품을 주요 대상으로 꼽았으며, 최대 매출 잠재력이 수억 달러에 달하는 자산이 적합할 수 있다고 말했습니다. 회사는 선호하는 방식으로 선별적인 '진주 목걸이' 전략을 언급했습니다.
유럽 시장 기회: 경영진은 유럽에 미국의 약 8,000명과 적어도 비견될 만한 수의 적격 2차 치료 환자가 있는 것으로 추정했습니다. 독일이 첫 번째 시장으로 선정된 이유는 약가 등재 경로가 실현 가능하고 제품의 혁신성을 반영할 수 있는 가격 책정이 가능하다고 판단했기 때문입니다.
실적 발표 컨퍼런스 콜 전문
전체 실적 발표 컨퍼런스 콜 녹취록
경영진 발표
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.
질의응답
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.
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