Geron Corporation Reports Third Quarter 2024 Financial Results and Recent Business Highlights
Geron (GERN) reported Q3 2024 financial results, achieving $28.2 million in RYTELO™ net product revenue in its first full quarter of sales. The company secured $250 million in financing through agreements with Royalty Pharma and Pharmakon Advisors, with access to an additional $125 million in debt. Q3 net loss was $26.4 million, or $0.04 per share. Total operating expenses were $56.5 million. The company expects 2024 total operating expenses between $260-270 million. Cash position as of September 30, 2024, was $378.9 million, with pro forma cash of $542.4 million including recent financing proceeds.
Geron (GERN) ha riportato i risultati finanziari del terzo trimestre del 2024, registrando 28,2 milioni di dollari di ricavi netti da prodotto RYTELO™ nel suo primo trimestre completo di vendite. L'azienda ha ottenuto 250 milioni di dollari di finanziamenti tramite accordi con Royalty Pharma e Pharmakon Advisors, con accesso a ulteriori 125 milioni di dollari in debito. La perdita netta del terzo trimestre è stata di 26,4 milioni di dollari, pari a 0,04 dollari per azione. Le spese operative totali sono ammontate a 56,5 milioni di dollari. L'azienda prevede che le spese operative totali per il 2024 siano comprese tra 260-270 milioni di dollari. La posizione di cassa al 30 settembre 2024 era di 378,9 milioni di dollari, con una cassa pro forma di 542,4 milioni di dollari che include i proventi del recente finanziamento.
Geron (GERN) reportó los resultados financieros del tercer trimestre de 2024, logrando 28,2 millones de dólares en ingresos netos de producto RYTELO™ en su primer trimestre completo de ventas. La empresa aseguró 250 millones de dólares en financiamiento a través de acuerdos con Royalty Pharma y Pharmakon Advisors, con acceso a 125 millones de dólares adicionales en deuda. La pérdida neta del tercer trimestre fue de 26,4 millones de dólares, o 0,04 dólares por acción. Los gastos operativos totales fueron de 56,5 millones de dólares. La compañía espera que los gastos operativos totales para 2024 estén entre 260-270 millones de dólares. La posición de efectivo al 30 de septiembre de 2024 era de 378,9 millones de dólares, con efectivo pro forma de 542,4 millones de dólares incluyendo los ingresos del financiamiento reciente.
Geron (GERN)은 2024년 3분기 재무 결과를 발표하며, 첫 전체 판매 분기에서 2,820만 달러의 RYTELO™ 순제품 수익을 달성했습니다. 회사는 Royalty Pharma 및 Pharmakon Advisors와의 계약을 통해 2억 5천만 달러의 자금을 확보했으며, 추가로 1억 2,500만 달러의 채무 접근을 가능하게 했습니다. 3분기 순손실은 2,640만 달러로, 주당 0.04달러에 해당합니다. 총 운영 비용은 5,650만 달러였습니다. 회사는 2024년 총 운영 비용을 2억 6천만~2억 7천만 달러로 예상하고 있습니다. 2024년 9월 30일 현재 현금 보유액은 3억 7,890만 달러였으며, 최근 자금조달 수익을 포함한 프로 포르마 현금은 5억 4,240만 달러입니다.
Geron (GERN) a annoncé les résultats financiers du troisième trimestre 2024, atteignant 28,2 millions de dollars de revenus nets de produit RYTELO™ lors de son premier trimestre complet de ventes. La société a obtenu 250 millions de dollars de financement grâce à des accords avec Royalty Pharma et Pharmakon Advisors, avec un accès à 125 millions de dollars supplémentaires en dette. La perte nette du troisième trimestre était de 26,4 millions de dollars, soit 0,04 dollar par action. Les dépenses d'exploitation totales s'élevaient à 56,5 millions de dollars. La société s'attend à ce que les dépenses d'exploitation totales pour 2024 se chiffrent entre 260-270 millions de dollars. La position de trésorerie au 30 septembre 2024 était de 378,9 millions de dollars, avec une trésorerie pro forma de 542,4 millions de dollars incluant les produits de financement récents.
Geron (GERN) hat die finanziellen Ergebnisse des dritten Quartals 2024 berichtet und erzielte 28,2 Millionen Dollar an Netto-Umsatz mit RYTELO™ im ersten vollen Verkaufsquartal. Das Unternehmen sicherte sich 250 Millionen Dollar an Finanzierung durch Vereinbarungen mit Royalty Pharma und Pharmakon Advisors und hat Zugang zu zusätzlichen 125 Millionen Dollar an Schulden. Der Nettoverlust im dritten Quartal betrug 26,4 Millionen Dollar, was 0,04 Dollar pro Aktie entspricht. Die Gesamtausgaben betrugen 56,5 Millionen Dollar. Das Unternehmen erwartet für 2024 Gesamtausgaben zwischen 260-270 Millionen Dollar. Die Barreserven zum 30. September 2024 betrugen 378,9 Millionen Dollar, mit einer pro forma Barreserve von 542,4 Millionen Dollar, einschließlich der Erlöse aus der jüngsten Finanzierung.
- Strong Q3 2024 RYTELO revenue of $28.2 million in first full quarter
- Secured $250 million in financing with access to additional $125 million
- Reduced Q3 net loss to $26.4 million from $44.8 million year-over-year
- Healthy cash position of $542.4 million (pro forma)
- Operating expenses increased to $56.5 million from $47.8 million year-over-year
- SG&A expenses rose to $35.9 million from $18.4 million year-over-year
- Interest expense increased to $3.0 million from $2.1 million year-over-year
Insights
The Q3 results showcase strong commercial momentum for Geron, with
Pro forma cash position of
The strong initial RYTELO sales indicate significant market penetration in lower-risk MDS, validating the commercial potential. The pending EU regulatory decision expected in late 2024/early 2025 represents a major growth catalyst, with planned commercialization in select EU markets by 2026. The appointment of an experienced CCO signals commitment to global commercial expansion.
The financing deals with favorable terms demonstrate institutional confidence in RYTELO's market potential. The upcoming Phase 3 IMpactMF trial interim analysis in early 2026 could expand the addressable market into relapsed/refractory MF, representing another significant growth opportunity.
Achieved
Received
“This has been a transformative year for Geron, following our first FDA approval and commercial launch of RYTELO in June. The initial full quarter of product revenue from our
Recent Business Highlights
-
Strong execution in the first full quarter of
U.S. launch, with net product revenue for RYTELO (imetelstat) of in the third quarter of 2024.$28.2 million -
In November 2024, completed synthetic royalty and debt financing transactions to strengthen our cash position and further solidify our balance sheet while providing strategic flexibility to invest in our future. We entered into a synthetic royalty agreement with Royalty Pharma providing
of capital in exchange for tiered royalty payments. We also entered into a 5-year, senior term loan agreement with Pharmakon for up to$125 million , from which we have drawn a first tranche of$250 million , a portion of which was used to fully repay amounts owed under our existing loan with Hercules Capital, Inc. and Silicon Valley Bank ($125 million ), which has now been terminated, with the ability to borrow another$86.5 million prior to the end of 2025, subject to specified conditions.$125 million - Jim Ziegler appointed as Executive Vice President, Chief Commercial Officer in September 2024, to spearhead Geron’s global commercial strategy and operations, lead the commercial organization and be responsible for driving growth of RYTELO. Mr. Ziegler brings more than 25 years of commercial experience in the biopharmaceutical industry, spanning leadership, strategic and operational roles in both large and smaller organizations.
- New data to be presented at upcoming American Society for Hematology (ASH) Annual Meeting highlights the potential of imetelstat in myeloid hematologic malignancies (please view ASH press release for more details).
Upcoming Milestones
- We expect review of the Marketing Authorization Application (MAA) for RYTELO in lower-risk MDS by the Committee for Medicinal Products for Human Use (CHMP) could be completed in late 2024 or early 2025, with potential approval by the European Commission in the first half of 2025. We are continuing to prepare for the potential launch of RYTELO in the EU, and subject to regulatory approval, are planning to commercialize RYTELO in select EU markets commencing in 2026.
-
We expect an interim analysis from the Phase 3 IMpactMF trial in patients with relapsed/refractory MF may occur in early 2026 (when approximately
35% of planned enrolled patients have died) and the final analysis may occur in early 2027 (when approximately50% of planned enrolled patients have died), based on our most recent planning assumptions for enrollment and death rates in the trial.
Third Quarter 2024 Financial Results
As of September 30, 2024, we had approximately
Net Loss
For the three and nine months ended September 30, 2024, the Company reported a net loss of
Revenues
Total product revenue, net for the three and nine months ended September 30, 2024, was
Total net revenue for the three and nine months ended September 30, 2024, was
Operating Expenses
Total operating expenses for the three and nine months ended September 30, 2024, were
Cost of goods sold was approximately
Research and development expenses for the three months and nine months ended September 30, 2024, were
Selling, general and administrative expenses for the three and nine months ended September 30, 2024, were
Interest income was
Interest expense was
2024 Financial Guidance
For fiscal year 2024, we expect total operating expenses to be in the range of approximately
Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities (including the
Conference Call
Geron will host a conference call at 8:00 a.m. ET on Thursday, November 7, 2024, to discuss business updates and third quarter 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/539655875
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.
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 ClinicalTrials.gov/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 expectations about the
Financial table follows.
GERON CORPORATION |
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CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||||||||||||
|
|
|
||||||||||
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Three Months Ended |
Nine Months Ended |
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|
September 30, |
September 30, |
||||||||||
(In thousands, except share and per share data) |
2024 |
|
2023 |
|
2024 |
|
2023 |
|
||||
|
(Unaudited) |
(Unaudited) |
(Unaudited) |
(Unaudited) |
||||||||
Revenues: |
|
|
|
|
||||||||
Product revenue, net |
$ |
28,209 |
|
$ |
- |
|
$ |
28,989 |
|
$ |
- |
|
Royalties |
|
62 |
|
|
164 |
|
|
468 |
|
|
214 |
|
|
|
28,271 |
|
|
164 |
|
|
29,457 |
|
|
214 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||
Cost of goods sold |
|
456 |
|
|
- |
|
|
473 |
|
|
- |
|
Research and development |
|
20,153 |
|
|
29,426 |
|
|
80,305 |
|
|
92,135 |
|
Selling, general and administrative |
|
35,877 |
|
|
18,350 |
|
|
102,361 |
|
|
47,734 |
|
Total operating expenses |
|
56,486 |
|
|
47,776 |
|
|
183,139 |
|
|
139,869 |
|
|
|
|
|
|
|
|
|
|
||||
Loss from Operations |
|
(28,215 |
) |
|
(47,612 |
) |
|
(153,682 |
) |
|
(139,655 |
) |
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
4,877 |
|
|
4,965 |
|
|
14,448 |
|
|
13,556 |
|
Interest expense |
|
(3,046 |
) |
|
(2,066 |
) |
|
(9,798 |
) |
|
(5,991 |
) |
Other income and (expense), net |
|
(63 |
) |
|
(92 |
) |
|
(188 |
) |
|
(64 |
) |
Net loss |
$ |
(26,447 |
) |
$ |
(44,805 |
) |
$ |
(149,220 |
) |
$ |
(132,154 |
) |
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share: |
|
|
|
|
|
|
|
|
||||
Net loss per share |
$ |
(0.04 |
) |
$ |
(0.08 |
) |
$ |
(0.23 |
) |
$ |
(0.23 |
) |
Shares used in computing net loss per share |
|
662,158,182 |
|
|
579,508,305 |
|
|
639,933,612 |
|
|
562,445,577 |
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
||||||||
|
|
September 30, |
|
|
December 31, |
|
||
(In thousands) |
|
2024 |
|
|
2023 |
|
||
|
|
(Unaudited) |
|
|
(Note 1) |
|
||
Current assets: |
|
|
|
|
|
|
||
Cash, cash equivalents and restricted cash |
|
$ |
62,198 |
|
|
$ |
71,138 |
|
Current marketable securities |
|
|
279,430 |
|
|
|
263,676 |
|
Other current assets |
|
|
56,429 |
|
|
|
6,534 |
|
Total current assets |
|
|
398,057 |
|
|
|
341,348 |
|
|
|
|
|
|
|
|
||
Noncurrent marketable securities |
|
|
37,312 |
|
|
|
43,298 |
|
Property and equipment, net |
1,595 |
1,177 |
||||||
Deposits and other assets |
|
|
7,986 |
|
|
|
8,253 |
|
|
|
$ |
444,950 |
|
|
$ |
394,076 |
|
|
|
|
|
|
|
|
||
Current liabilities |
|
$ |
137,933 |
|
|
$ |
108,070 |
|
Noncurrent liabilities |
|
|
14,733 |
|
|
|
38,057 |
|
Stockholders’ equity |
|
|
292,284 |
|
|
|
247,949 |
|
|
|
$ |
444,950 |
|
|
$ |
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, 2023. |
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107956579/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 was Geron's (GERN) RYTELO revenue in Q3 2024?
How much financing did Geron (GERN) secure in November 2024?
What is Geron's (GERN) cash position as of Q3 2024?