Geron Corporation Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights
Geron (GERN) reported strong Q4 2024 financial results, achieving $47.5 million in RYTELO™ net product revenue in Q4 and $76.5 million since its June 2024 launch. The company ended 2024 with $502.9 million in cash and equivalents.
Key financial metrics include a Q4 net loss of $25.4 million ($0.04 per share) and full-year net loss of $174.6 million ($0.27 per share). Operating expenses totaled $67.6 million for Q4 and $250.7 million for 2024.
Notable developments include receiving positive CHMP opinion for RYTELO in Europe, with expected approval in H1 2025 and commercialization in select EU countries in 2026. The Phase 3 IMpactMF trial reached 80% enrollment, with interim analysis expected in H2 2026.
Geron (GERN) ha riportato solidi risultati finanziari per il quarto trimestre del 2024, raggiungendo 47,5 milioni di dollari di entrate nette da prodotto RYTELO™ nel quarto trimestre e 76,5 milioni di dollari dalla sua lancio nel giugno 2024. L'azienda ha chiuso il 2024 con 502,9 milioni di dollari in contante e equivalenti.
I principali indicatori finanziari includono una perdita netta di 25,4 milioni di dollari nel quarto trimestre (0,04 dollari per azione) e una perdita netta annuale di 174,6 milioni di dollari (0,27 dollari per azione). Le spese operative hanno totalizzato 67,6 milioni di dollari per il quarto trimestre e 250,7 milioni di dollari per il 2024.
Sviluppi significativi includono il ricevimento di un parere positivo dal CHMP per RYTELO in Europa, con approvazione prevista nel primo semestre del 2025 e commercializzazione in alcuni paesi dell'UE nel 2026. Il trial di Fase 3 IMpactMF ha raggiunto l'80% di arruolamento, con analisi intermedie previste nel secondo semestre del 2026.
Geron (GERN) reportó sólidos resultados financieros para el cuarto trimestre de 2024, alcanzando 47,5 millones de dólares en ingresos netos de producto RYTELO™ en el cuarto trimestre y 76,5 millones de dólares desde su lanzamiento en junio de 2024. La compañía cerró 2024 con 502,9 millones de dólares en efectivo y equivalentes.
Los principales indicadores financieros incluyen una pérdida neta de 25,4 millones de dólares en el cuarto trimestre (0,04 dólares por acción) y una pérdida neta anual de 174,6 millones de dólares (0,27 dólares por acción). Los gastos operativos totalizaron 67,6 millones de dólares para el cuarto trimestre y 250,7 millones de dólares para 2024.
Desarrollos notables incluyen la recepción de una opinión positiva del CHMP para RYTELO en Europa, con aprobación esperada en el primer semestre de 2025 y comercialización en algunos países de la UE en 2026. El ensayo de Fase 3 IMpactMF alcanzó el 80% de inscripción, con análisis intermedios esperados en el segundo semestre de 2026.
Geron (GERN)은 2024년 4분기 강력한 재무 결과를 보고하며, 4분기 동안 RYTELO™의 순제품 수익으로 4,750만 달러를 달성하고 2024년 6월 출시 이후 총 7,650만 달러를 기록했습니다. 회사는 2024년을 5억 2,900만 달러의 현금 및 현금성 자산으로 마감했습니다.
주요 재무 지표로는 4분기 순손실이 2,540만 달러 (주당 0.04달러)였고, 연간 순손실은 1억 7,460만 달러 (주당 0.27달러)였습니다. 운영비는 4분기 동안 6,760만 달러, 2024년에는 2억 5,070만 달러에 달했습니다.
주목할 만한 발전으로는 유럽에서 RYTELO에 대한 CHMP의 긍정적인 의견을 받았으며, 2025년 상반기에 승인이 예상되고 2026년에는 일부 EU 국가에서 상용화될 예정입니다. 3상 IMpactMF 시험은 80% 등록을 달성했으며, 2026년 하반기에 중간 분석이 예상됩니다.
Geron (GERN) a annoncé de solides résultats financiers pour le quatrième trimestre de 2024, atteignant 47,5 millions de dollars de revenus nets de produits RYTELO™ au quatrième trimestre et 76,5 millions de dollars depuis son lancement en juin 2024. L'entreprise a terminé 2024 avec 502,9 millions de dollars en liquidités et équivalents.
Les principaux indicateurs financiers incluent une perte nette de 25,4 millions de dollars au quatrième trimestre (0,04 dollar par action) et une perte nette annuelle de 174,6 millions de dollars (0,27 dollar par action). Les frais d'exploitation se sont élevés à 67,6 millions de dollars pour le quatrième trimestre et à 250,7 millions de dollars pour 2024.
Les développements notables incluent la réception d'un avis positif du CHMP pour RYTELO en Europe, avec une approbation prévue au premier semestre 2025 et une commercialisation dans certains pays de l'UE en 2026. L'essai de Phase 3 IMpactMF a atteint 80 % d'inscription, avec une analyse intermédiaire attendue au second semestre 2026.
Geron (GERN) hat starke finanzielle Ergebnisse für das vierte Quartal 2024 gemeldet und erzielte 47,5 Millionen Dollar an Nettoumsätzen aus dem Produkt RYTELO™ im vierten Quartal sowie 76,5 Millionen Dollar seit der Markteinführung im Juni 2024. Das Unternehmen schloss das Jahr 2024 mit 502,9 Millionen Dollar an Bargeld und Äquivalenten ab.
Wichtige Finanzkennzahlen umfassen einen Nettoverlust von 25,4 Millionen Dollar im vierten Quartal (0,04 Dollar pro Aktie) und einen Nettoverlust für das Gesamtjahr von 174,6 Millionen Dollar (0,27 Dollar pro Aktie). Die Betriebskosten beliefen sich im vierten Quartal auf 67,6 Millionen Dollar und für 2024 auf 250,7 Millionen Dollar.
Bemerkenswerte Entwicklungen umfassen die positive Stellungnahme des CHMP für RYTELO in Europa, mit einer erwarteten Genehmigung im ersten Halbjahr 2025 und einer Kommerzialisierung in ausgewählten EU-Ländern im Jahr 2026. Die Phase-3-Studie IMpactMF erreichte eine Einschreibungsrate von 80%, mit einer Zwischenanalyse, die für das zweite Halbjahr 2026 erwartet wird.
- Q4 revenue of $47.5M exceeded expectations
- Strong cash position of $502.9M
- Positive CHMP opinion for European market entry
- 80% enrollment achieved in Phase 3 IMpactMF trial
- Expected profitability without additional financing
- Net loss of $174.6M for full year 2024
- Operating expenses increased to $250.7M from $194.2M YoY
- Selling, general and administrative expenses doubled to $145.7M
- Interest expense increased to $18.5M from $8.3M YoY
- $1.7M loss on debt extinguishment
Insights
Geron's Q4 2024 results reveal an impressively steep launch trajectory for RYTELO (imetelstat), with
The quarterly revenue run-rate of
While operating expenses increased year-over-year from
The
The relapsed/refractory myelofibrosis opportunity represents a potential second growth catalyst, with the Phase 3 trial now
The 2025 operating expense guidance of
RYTELO's commercial success reflects its unique position as the first telomerase inhibitor approved for hematologic malignancies. Unlike other MDS therapies that primarily address symptoms, imetelstat targets the fundamental disease biology by inhibiting telomerase activity in malignant stem cells, potentially offering disease-modifying effects rather than just symptomatic management.
The strong market uptake suggests hematologists recognize the clinical value of RYTELO's differentiated profile in lower-risk MDS, particularly its ability to achieve transfusion independence in approximately
The ASH 2024 data demonstrating imetelstat's activity regardless of prior therapy type or number is particularly significant. This suggests broad applicability across the heterogeneous MDS population, including patients who have failed hypomethylating agents (HMAs) - a group with extremely options. This positions RYTELO as a potential standard option across multiple lines of therapy in lower-risk MDS.
The
The Phase 1 IMproveMF findings on imetelstat plus ruxolitinib combination therapy open another potential treatment pathway. JAK inhibitors alone provide symptomatic relief but minimal disease modification in MF. Adding imetelstat's telomerase inhibition could potentially address the disease at the stem cell level while maintaining symptom control - a mechanistically rational combination approach.
The positive CHMP recommendation validates imetelstat's clinical profile and suggests European approval is likely in H1 2025. European commercialization will require navigating complex reimbursement landscapes but represents a substantial market opportunity comparable to the US in patient numbers.
Achieved
Expect to reach profitability without additional financing if current internal sales and operating expenses expectations are met
"2024 was a terrific year for Geron and for RYTELO, our first-in-class telomerase inhibitor, which we believe represents a highly differentiated treatment with blockbuster potential in the high unmet need, lower-risk MDS patient population. We also continued to progress our development efforts in relapsed/refractory myelofibrosis, which could potentially double our commercial opportunity if our IMpactMF Phase 3 trial reads out positively and we are approved in this indication. From a financial perspective, we ended the year with a strong cash position, and Q3 and Q4 revenues exceeded our expectations. Heading into 2025, we are excited by the strategic and leadership changes we put in place early in the launch, which we believe will position us to increase our revenue growth trajectory and more fully capture the significant commercial opportunity over the next several quarters," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer.
Recent Business Highlights
-
Continued execution on
U.S. commercial launch, with net product revenue for RYTELO (imetelstat) of$47.5 million $76.5 million U.S. Food and Drug Administration (FDA).
- Received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in December 2024 recommending approval of RYTELO for the treatment of certain adult patients with transfusion-dependent anemia due to lower-risk MDS. Subject to receiving regulatory approval, which is expected in the first half of 2025, Geron is preparing to commercialize RYTELO in select EU countries in 2026.
-
Achieved approximately
80% enrollment in the Phase 3 IMpactMF trial evaluating imetelstat in patients with relapsed/refractory myelofibrosis (R/R MF). Based on our current planning assumptions for enrollment and event (death) rates in the trial, we now expect the interim analysis for overall survival may occur in the second half of 2026 (when approximately35% of planned enrolled patients have died) and the final analysis may occur in the second half of 2028 (when approximately50% of planned enrolled patients have died).
- Presented new data at the 66th American Society for Hematology (ASH) Annual Meeting in December 2024, including analyses of IMerge Phase 3 data suggesting clinical activity of imetelstat in patients with lower-risk MDS regardless of type or number of prior therapies and Phase 1 findings from IMproveMF suggesting tolerability of imetelstat in combination with ruxolitinib as a potential frontline therapy in patients with MF.
Fourth Quarter 2024 Financial Results
As of December 31, 2024, we had approximately
Net Loss
For the three and twelve months ended December 31, 2024, the Company reported a net loss of
Revenues
Total product revenue, net for the three and twelve months ended December 31, 2024, was
Total net revenue for the three and twelve months ended December 31, 2024, was
Operating Expenses
Total operating expenses for the three and twelve months ended December 31, 2024, were
Cost of goods sold was approximately
Research and development expenses for the three and twelve months ended December 31, 2024, were
Selling, general and administrative expenses for the three and twelve months ended December 31, 2024, were
Interest income was
Interest expense was
Loss on extinguishment of debt
We recorded a loss on the extinguishment of debt of
2025 Financial Guidance
For fiscal year 2025, we expect total operating expenses to be in the range of approximately
We expect to reach profitability without additional financing if our current internal sales and operating expense expectations are met. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from
Conference Call
Geron will host a conference call at 8:00 a.m. ET on Wednesday, February 26, 2024, to discuss business updates and fourth quarter and full year 2024 financial results.
A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.
Participants may access the webcast by registering online using the following link, https://events.q4inc.com/attendee/332361629
About RYTELO (imetelstat)
RYTELO (imetelstat) is an FDA-approved oligonucleotide telomerase inhibitor for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent anemia requiring four or more red blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.
A marketing authorization application for RYTELO is under review by the European Commission as a monotherapy treatment for adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the
About Geron
Geron is a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer. Our first-in-class telomerase inhibitor RYTELO™ (imetelstat) is approved in
About IMpactMF Phase 3
IMpactMF is an open label, randomized, controlled Phase 3 clinical trial with registrational intent. The trial is designed to enroll approximately 320 patients with intermediate-2 or high-risk myelofibrosis (MF) who are relapsed after or refractory to prior treatment with a JAK inhibitor, also referred to as relapsed/refractory MF. Patients will be randomized to receive either imetelstat or best available therapy. The primary endpoint is overall survival (OS). Key secondary endpoints include symptom response, spleen response, progression free survival, complete remission, partial remission, clinical improvement, duration of response, safety, pharmacokinetics, and patient reported outcomes. IMpactMF is currently enrolling patients. For further information about IMpactMF, including enrollment criteria, locations and current status, visit https://www.clinicaltrials.gov/study/NCT04576156.
IMPORTANT SAFETY INFORMATION ABOUT RYTELO
WARNINGS AND PRECAUTIONS
Thrombocytopenia
RYTELO can cause thrombocytopenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased platelets occurred in
Monitor patients with thrombocytopenia for bleeding. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer platelet transfusions as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.
Neutropenia
RYTELO can cause neutropenia based on laboratory values. In the clinical trial, new or worsening Grade 3 or 4 decreased neutrophils occurred in
Monitor patients with Grade 3 or 4 neutropenia for infections, including sepsis. Monitor complete blood cell counts prior to initiation of RYTELO, weekly for the first two cycles, prior to each cycle thereafter, and as clinically indicated. Administer growth factors and anti-infective therapies for treatment or prophylaxis as appropriate. Delay the next cycle and resume at the same or reduced dose, or discontinue as recommended.
Infusion-Related Reactions
RYTELO can cause infusion-related reactions. In the clinical trial, infusion-related reactions occurred in
Premedicate patients at least 30 minutes prior to infusion with diphenhydramine and hydrocortisone as recommended and monitor patients for one hour following the infusion as recommended. Manage symptoms of infusion-related reactions with supportive care and infusion interruptions, decrease infusion rate, or permanently discontinue as recommended.
Embryo-Fetal Toxicity
RYTELO can cause embryo-fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with RYTELO and for 1 week after the last dose.
ADVERSE REACTIONS
Serious adverse reactions occurred in
Most common adverse reactions (≥
Please see RYTELO (imetelstat) full Prescribing Information, including Medication Guide, available at https://pi.geron.com/products/US/pi/rytelo_pi.pdf.
Use of Forward-Looking Statements
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such statements, include, without limitation, those regarding: (i) the Company’s belief that RYTELO represents a highly differentiated treatment with blockbuster potential in the high unmet need, lower-risk MDS patient population; (ii) the Company’s belief that if the Phase 3 IMpactMF trial in R/R MF reads out positively and imetelstat is approved in this indication, it could potentially double the Company’s commercial opportunity; (iii) the Company’s belief that the strategic and leadership changes it put in place early in the launch will position it to increase its revenue growth trajectory and more fully capture the significant commercial opportunity over the next several quarters; (iv) the Company’s expectations about the
Financial tables follow.
GERON CORPORATION CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
|
Three Months Ended |
Year Ended |
||||||||||
|
December 31, |
December 31, |
||||||||||
(In thousands, except share and per share data) |
2024 |
2023 |
2024 |
2023 |
||||||||
|
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Unaudited) |
||||||||
Revenues: |
|
|
|
|
||||||||
Product revenue, net |
$ |
47,507 |
|
$ |
— |
|
$ |
76,495 |
|
$ |
— |
|
Royalties |
|
31 |
|
|
23 |
|
|
499 |
|
|
237 |
|
|
|
47,538 |
|
|
23 |
|
|
76,994 |
|
|
237 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||
Cost of goods sold |
|
783 |
|
|
— |
|
|
1,256 |
|
|
— |
|
Research and development |
|
23,433 |
|
|
32,911 |
|
|
103,738 |
|
|
125,046 |
|
Selling, general and administrative |
|
43,371 |
|
|
21,401 |
|
|
145,732 |
|
|
69,135 |
|
Total operating expenses |
|
67,587 |
|
|
54,312 |
|
|
250,726 |
|
|
194,181 |
|
|
|
|
|
|
|
|
|
|
||||
Loss from operations |
|
(20,049 |
) |
|
(54,289 |
) |
|
(173,732 |
) |
|
(193,944 |
) |
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
5,159 |
|
|
4,595 |
|
|
19,607 |
|
|
18,152 |
|
Interest expense |
|
(8,707 |
) |
|
(2,321 |
) |
|
(18,504 |
) |
|
(8,312 |
) |
Other income and (expense), net |
|
(48 |
) |
|
41 |
|
|
(236 |
) |
|
(23 |
) |
Loss on extinguishment of debt |
|
(1,707 |
) |
|
— |
|
|
(1,707 |
) |
|
— |
|
Net loss |
$ |
(25,352 |
) |
$ |
(51,974 |
) |
$ |
(174,572 |
) |
$ |
(184,127 |
) |
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
||||
Net loss per share |
$ |
(0.04 |
) |
$ |
(0.09 |
) |
$ |
(0.27 |
) |
$ |
(0.32 |
) |
Shares used in computing net loss per share |
|
664,199,550 |
|
|
594,977,503 |
|
|
646,033,247 |
|
|
570,645,405 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
December 31, |
|
December 31, |
||||
(In thousands) |
|
2024 |
|
2023 |
||||
|
|
(Unaudited) |
|
|
(Note 1) |
|
||
Current assets: |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
$ |
80,876 |
|
|
$ |
71,138 |
|
Current marketable securities |
|
|
327,550 |
|
|
|
263,676 |
|
Other current assets |
|
|
82,566 |
|
|
|
6,534 |
|
Total current assets |
|
|
490,992 |
|
|
|
341,348 |
|
|
|
|
|
|
|
|
||
Noncurrent marketable securities |
|
|
94,519 |
|
|
|
43,298 |
|
Property and equipment, net |
|
|
1,310 |
|
|
|
1,177 |
|
Deposits and other assets |
|
|
6,960 |
|
|
|
8,253 |
|
|
|
$ |
593,781 |
|
|
$ |
394,076 |
|
|
|
|
|
|
|
|
||
Current liabilities |
|
$ |
88,298 |
|
|
$ |
108,070 |
|
Noncurrent liabilities |
|
|
225,163 |
|
|
|
38,057 |
|
Stockholders’ equity |
|
|
280,320 |
|
|
|
247,949 |
|
|
|
$ |
593,781 |
|
|
$ |
394,076 |
|
Note 1: |
Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2024. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20250226054915/en/
Aron Feingold
Vice President, Investor Relations and Corporate Communications
Kristen Kelleher
Associate Director, Investor Relations and Corporate Communications
investor@geron.com
media@geron.com
Source: Geron Corporation
FAQ
What were GERN's Q4 2024 RYTELO sales and how do they compare to launch expectations?
When does Geron expect to achieve profitability based on current projections?
What is the timeline for GERN's European RYTELO launch?
What are GERN's operating expense projections for 2025?
When will GERN's IMpactMF trial interim analysis be available?
