TG Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2024 Financial Results
TG Therapeutics (NASDAQ: TGTX) reported strong financial results for Q4 and full year 2024, with BRIUMVI U.S. net revenue reaching $103.6 million in Q4 and $310 million for the full year, marking approximately 250% growth year-over-year.
Key highlights include:
- Target guidance of $540 million in total global revenue for 2025
- Extended BRIUMVI patent protection through 2042
- Successful European launch with partner Neuraxpharm
- Impressive 5-year clinical data showing 92% of patients free from disability progression
The company reported net income of $23.3 million for Q4 2024 and $23.4 million for the full year. Cash position stands at $311.0 million as of December 31, 2024. R&D expenses increased to $94.3 million for 2024, while SG&A expenses rose to $154.3 million, primarily due to BRIUMVI commercialization efforts.
TG Therapeutics (NASDAQ: TGTX) ha riportato risultati finanziari solidi per il quarto trimestre e l'intero anno 2024, con i ricavi netti di BRIUMVI negli Stati Uniti che hanno raggiunto i 103,6 milioni di dollari nel quarto trimestre e 310 milioni di dollari per l'intero anno, segnando una crescita di circa il 250% rispetto all'anno precedente.
I punti salienti includono:
- Obiettivo di 540 milioni di dollari in ricavi globali totali per il 2025
- Protezione del brevetto di BRIUMVI estesa fino al 2042
- Lancio europeo di successo con il partner Neuraxpharm
- Dati clinici impressionanti a 5 anni che mostrano il 92% dei pazienti liberi dalla progressione della disabilità
La società ha riportato un reddito netto di 23,3 milioni di dollari per il quarto trimestre 2024 e 23,4 milioni di dollari per l'intero anno. La posizione di cassa è di 311,0 milioni di dollari al 31 dicembre 2024. Le spese per R&S sono aumentate a 94,3 milioni di dollari per il 2024, mentre le spese SG&A sono salite a 154,3 milioni di dollari, principalmente a causa degli sforzi di commercializzazione di BRIUMVI.
TG Therapeutics (NASDAQ: TGTX) reportó resultados financieros sólidos para el cuarto trimestre y el año completo 2024, con ingresos netos de BRIUMVI en EE. UU. alcanzando los 103,6 millones de dólares en el cuarto trimestre y 310 millones de dólares para el año completo, marcando un crecimiento de aproximadamente el 250% en comparación con el año anterior.
Los aspectos destacados incluyen:
- Orientación objetivo de 540 millones de dólares en ingresos globales totales para 2025
- Protección de la patente de BRIUMVI extendida hasta 2042
- Lanzamiento europeo exitoso con el socio Neuraxpharm
- Impresionantes datos clínicos a 5 años que muestran que el 92% de los pacientes están libres de progresión de discapacidad
La compañía reportó un ingreso neto de 23,3 millones de dólares para el cuarto trimestre de 2024 y 23,4 millones de dólares para el año completo. La posición de efectivo es de 311,0 millones de dólares al 31 de diciembre de 2024. Los gastos de I+D aumentaron a 94,3 millones de dólares para 2024, mientras que los gastos SG&A subieron a 154,3 millones de dólares, principalmente debido a los esfuerzos de comercialización de BRIUMVI.
TG Therapeutics (NASDAQ: TGTX)는 2024년 4분기 및 전체 연도에 대한 강력한 재무 결과를 보고했으며, BRIUMVI의 미국 순수익은 4분기에 1억 360만 달러, 연간 3억 1000만 달러에 달해 전년 대비 약 250% 성장했습니다.
주요 하이라이트는 다음과 같습니다:
- 2025년 총 글로벌 수익 목표 5억 4000만 달러
- BRIUMVI 특허 보호 2042년까지 연장
- 파트너 Neuraxpharm과 함께 성공적인 유럽 출시
- 장애 진행이 없는 환자가 92%인 인상적인 5년 임상 데이터
회사는 2024년 4분기에 2330만 달러의 순이익을 보고했으며, 연간 2340만 달러의 순이익을 기록했습니다. 2024년 12월 31일 기준 현금 보유액은 3억 1100만 달러입니다. R&D 비용은 2024년 9430만 달러로 증가했으며, SG&A 비용은 BRIUMVI 상업화 노력으로 인해 1억 5430만 달러로 증가했습니다.
TG Therapeutics (NASDAQ: TGTX) a rapporté de solides résultats financiers pour le quatrième trimestre et l'année entière 2024, avec des revenus nets de BRIUMVI aux États-Unis atteignant 103,6 millions de dollars au quatrième trimestre et 310 millions de dollars pour l'année entière, marquant une croissance d'environ 250 % par rapport à l'année précédente.
Les points clés incluent:
- Prévisions de 540 millions de dollars de revenus globaux totaux pour 2025
- Protection du brevet BRIUMVI prolongée jusqu'en 2042
- Lancement européen réussi avec le partenaire Neuraxpharm
- Données cliniques impressionnantes sur 5 ans montrant que 92 % des patients sont exempts de progression de l'incapacité
L'entreprise a déclaré un revenu net de 23,3 millions de dollars pour le quatrième trimestre 2024 et de 23,4 millions de dollars pour l'année entière. La position de trésorerie s'élève à 311,0 millions de dollars au 31 décembre 2024. Les dépenses en R&D ont augmenté à 94,3 millions de dollars pour 2024, tandis que les dépenses SG&A ont atteint 154,3 millions de dollars, principalement en raison des efforts de commercialisation de BRIUMVI.
TG Therapeutics (NASDAQ: TGTX) hat starke Finanzergebnisse für das vierte Quartal und das gesamte Jahr 2024 gemeldet, wobei die Nettoerlöse von BRIUMVI in den USA im vierten Quartal 103,6 Millionen Dollar und im gesamten Jahr 310 Millionen Dollar erreichten, was einem Wachstum von etwa 250 % im Vergleich zum Vorjahr entspricht.
Wichtige Highlights sind:
- Zielvorgabe von 540 Millionen Dollar an globalen Gesamterlösen für 2025
- Erweiterter Patentschutz für BRIUMVI bis 2042
- Erfolgreicher europäischer Markteintritt mit Partner Neuraxpharm
- Beeindruckende klinische Daten über 5 Jahre, die zeigen, dass 92 % der Patienten frei von Behinderungsfortschritt sind
Das Unternehmen berichtete für das vierte Quartal 2024 von einem Nettogewinn von 23,3 Millionen Dollar und von 23,4 Millionen Dollar für das gesamte Jahr. Die Liquiditätsposition beträgt zum 31. Dezember 2024 311,0 Millionen Dollar. Die F&E-Ausgaben stiegen auf 94,3 Millionen Dollar für 2024, während die SG&A-Ausgaben auf 154,3 Millionen Dollar anstiegen, hauptsächlich aufgrund der Kommerzialisierungsbemühungen von BRIUMVI.
- 250% year-over-year revenue growth
- Net income of $23.4 million for full year 2024
- Strong cash position of $311 million
- Patent protection extended through 2042
- 92% success rate in 5-year clinical data
- European market expansion through Neuraxpharm partnership
- R&D expenses increased 24% to $94.3 million
- SG&A expenses rose 26% to $154.3 million
Insights
TG Therapeutics has delivered exceptional commercial performance in 2024, with BRIUMVI generating
Management's 2025 guidance of approximately
Three key financial elements strengthen the investment case: First, the company's
The subcutaneous formulation development represents a strategic initiative that could enhance BRIUMVI's competitive positioning through improved administration convenience while potentially opening new market segments. Meanwhile, pipeline expansion into myasthenia gravis and other autoimmune indications could significantly expand the addressable market beyond the current MS franchise.
BRIUMVI's clinical data demonstrates remarkable durability of effect with
The ENHANCE Phase 3b trial yielded two operationally significant findings: First, rapid 30-minute infusions proved well-tolerated, addressing a key administration barrier. Second, patients already B-cell depleted from prior anti-CD20 therapy could switch directly to the full 450mg BRIUMVI dose without requiring the standard stepped approach, with
The subcutaneous ublituximab development program represents a potential paradigm shift in administration convenience. If successful, this could eliminate the infusion center requirement altogether, significantly reducing healthcare system burden while improving patient experience. The Phase 1 trial initiation suggests the company has overcome the formulation challenges typically associated with adapting monoclonal antibodies to subcutaneous delivery.
TG's strategic expansion into autoimmune indications beyond MS leverages their anti-CD20 expertise while diversifying clinical risk. The allogeneic CD19 CAR T therapy program (azer-cel) licensed from Precision BioSciences represents a scientifically sound approach to targeting B-cell pathology in autoimmune conditions through a potentially one-time intervention rather than chronic therapy. The progressive MS trial initiation indicates the company is focusing on high unmet need patient populations where competitive differentiation may be more achievable.
Fourth quarter and full year 2024 BRIUMVI U.S. net revenue of
Target guidance of approximately
Conference call to be held today, March 3, 2025, at 8:30 AM ET
NEW YORK, March 03, 2025 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (the Company or TG Therapeutics) today announced its financial results for the fourth quarter and full year ended December 31, 2024, along with recent company developments.
Michael S. Weiss, the Company's Chairman and Chief Executive Officer, stated, “2024 was a year of significant outperformance and growth for TG, highlighted by the strong adoption of BRIUMVI for adult patients with relapsing forms of multiple sclerosis, which surpassed our initial expectations. Additionally, we made meaningful progress in strengthening our BRIUMVI patent portfolio through 2042, launching new clinical trials, including for subcutaneous BRIUMVI, and advancing our pipeline. These accomplishments provide a solid foundation as we look toward continued success in 2025.”
2024 Highlights & Recent Developments
BRIUMVI® (ublituximab-xiiy) Commercialization
- BRIUMVI United States (U.S.) net product revenue of
$103.6 million and$310 million for the fourth quarter and full year of 2024, respectively, representing approximately250% growth year over year - Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042
- BRIUMVI launched in Europe with our partner, Neuraxpharm, which is now commercially available in several additional countries in the European Union and United Kingdom
BRIUMVI Data Presentations
- Presented five-year data from the open-label extension study of the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI in adult patients with relapsing forms of multiple sclerosis (RMS) which demonstrated that
92% of patients were free from disability progression after five years of treatment, an annualized relapse rate of 0.02 during year 5 of treatment (equivalent to one relapse occurring every fifty years of patient treatment), and an overall safety profile that remained consistent over 5 years of continuous treatment, with no new safety signals emerging with prolonged treatment. - Presented data from the ENHANCE Phase 3b trial evaluating BRIUMVI in patients with RMS which demonstrated that:
- Rapid 30-minute BRIUMVI infusions are well tolerated in over 80 patients with RMS, and
- RMS patients who were already B-cell depleted from a prior anti-CD20 therapy were able to switch directly to a full 450 mg dose of BRIUMVI administered in 1 hour, without a 150 mg initial dose, with
97% of infusions being completed without interruption or slowing.
Pipeline
- Launched a Phase 1 trial evaluating subcutaneous ublituximab in patients with relapsing forms of multiple sclerosis (MS)
- Enrolled patients with Myasthenia Gravis (MG) into a Phase 1 trial with subcutaneous ublituximab
- Entered into a global license agreement with Precision BioSciences, Inc. (Precision) for the development and commercialization of Precision’s allogeneic CD19 CAR T therapy program, azercabtagene zapreleucel (azer-cel), for the treatment of autoimmune disorders and launched a Phase 1 trial in primary progressive multiple sclerosis
2025 Financial Guidance
- Full Year 2025 target total global revenue of approximately
$540 million , including BRIUMVI U.S. net product revenue of approximately$525 million - Full year 2025 target operating expense of approximately
$300 million (excluding non-cash compensation)
2025 Development Pipeline Anticipated Milestones
- Commence pivotal program of subcutaneous ublituximab
- Commence a pivotal program based on data from the ENHANCE trial with the goal of enhancing the patient experience on intravenous BRIUMVI
- Enroll participants into the ongoing trial evaluating BRIUMVI in autoimmune diseases outside of MS
- Enroll participants into the Phase 1 azer-cel trial in autoimmune disease, beginning with progressive forms of MS
- Present updated data at major medical conferences throughout the year
Financial Results for Fourth Quarter and Full Year 2024
- Product Revenue, net: Product revenue, net was approximately
$107.3 million and$313.7 million for the three and twelve months ended December 31, 2024, respectively, compared to$43.1 million and$92.0 million for the three and twelve months ended December 31, 2023, respectively. Product revenue, net consists primarily of net product sales of BRIUMVI in the United States, which totaled$103.6 million and$310.0 million during the three and twelve months ended December 31, 2024, respectively. Also included in product revenue, net during the three months ended December 31, 2023 and 2024 is approximately$3.2 million and$3.7 million , respectively, for product sold to our partner Neuraxpharm to support the Ex-US commercialization of BRIUMVI. - License, milestone, royalty and other revenue: License, milestone, royalty and other revenue was approximately
$0.8 million and$15.3 million for the three and twelve months ended December 31, 2024, respectively, compared to$0.8 million and$141.7 million for the three and twelve months ended December 31, 2023, respectively. License, milestone, royalty and other revenue for the twelve months ended December 31, 2024, is predominantly comprised of a$12.5 million milestone payment under the Neuraxpharm Commercialization Agreement for the first key market commercial launch of BRIUMVI in the European Union (EU) which occurred in the first quarter of 2024. License, milestone, royalty and other revenue for the twelve months ended December 31, 2023 is predominantly comprised of recognition of the one-time$140.0 million non-refundable upfront payment under the Commercialization Agreement with Neuraxpharm. - R&D Expenses: Total research and development (R&D) expense was approximately
$23.9 million and$94.3 million for the three and twelve months ended December 31, 2024, respectively, compared to$17.4 million and$76.2 million for the three and twelve months ended December 31, 2023, respectively. The increase in R&D expense during the three and twelve months ended December 31, 2024 was primarily attributable to manufacturing and development costs incurred in connection with our ublituximab subcutaneous development work, as well as license and milestone expense related to the license agreement with Precision BioSciences, Inc., during the period. - SG&A Expenses: Total selling, general and administrative (SG&A) expense was approximately
$39.0 million and$154.3 million for the three and twelve months ended December 31, 2024, respectively, compared to$31.2 million and$122.7 million for the three and twelve months ended December 31, 2023, respectively. The increase in both periods was primarily due to other selling, general and administrative costs, including personnel and consultants, associated with the commercialization of BRIUMVI during the period ended December 31, 2024. - Net Income (Loss): Net income was
$23.3 million and$23.4 million for the three and twelve months ended December 31, 2024, respectively, compared to a net loss of ($14.4) million for the three months ended December 31, 2023 and net income of$12.7 million for the twelve months ended December 31, 2023, respectively. - Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were
$311.0 million as of December 31, 2024. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2024, combined with the projected revenues from BRIUMVI, will be sufficient to fund our business based on our current operating plan.
CONFERENCE CALL INFORMATION
The Company will host a conference call today, March 3, 2025, at 8:30 AM ET, to discuss the Company’s financial results from the fourth quarter and full year ended December 31, 2024.
To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for a period of 30 days after the call.
ABOUT BRIUMVI® (ublituximab-xiiy) 150 mg/6 mL Injection for IV
BRIUMVI is a novel monoclonal antibody that targets a unique epitope on CD20-expressing B-cells. Targeting CD20 using monoclonal antibodies has proven to be an important therapeutic approach for the management of autoimmune disorders, such as RMS. BRIUMVI is uniquely designed to lack certain sugar molecules normally expressed on the antibody. Removal of these sugar molecules, a process called glycoengineering, allows for efficient B-cell depletion at low doses.
BRIUMVI is indicated in the U.S. for the treatment of adults with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease and in the EU and UK for the treatment of adult patients with RMS with active disease defined by clinical or imaging features.
A list of authorized specialty distributors can be found at www.briumvi.com.
IMPORTANT SAFETY INFORMATION
Contraindications: BRIUMVI is contraindicated in patients with:
- Active Hepatitis B Virus infection
- A history of life-threatening infusion reaction to BRIUMVI
WARNINGS AND PRECAUTIONS
Infusion Reactions: BRIUMVI can cause infusion reactions, which can include pyrexia, chills, headache, influenza-like illness, tachycardia, nausea, throat irritation, erythema, and an anaphylactic reaction. In MS clinical trials, the incidence of infusion reactions in BRIUMVI-treated patients who received infusion reaction-limiting premedication prior to each infusion was
Observe treated patients for infusion reactions during the infusion and for at least one hour after the completion of the first two infusions unless infusion reaction and/or hypersensitivity has been observed in association with the current or any prior infusion. Inform patients that infusion reactions can occur up to 24 hours after the infusion. Administer the recommended pre-medication to reduce the frequency and severity of infusion reactions. If life-threatening, stop the infusion immediately, permanently discontinue BRIUMVI, and administer appropriate supportive treatment. Less severe infusion reactions may involve temporarily stopping the infusion, reducing the infusion rate, and/or administering symptomatic treatment.
Infections: Serious, life-threatening or fatal, bacterial and viral infections have been reported in BRIUMVI-treated patients. In MS clinical trials, the overall rate of infections in BRIUMVI-treated patients was
Consider the potential for increased immunosuppressive effects when initiating BRIUMVI after immunosuppressive therapy or initiating an immunosuppressive therapy after BRIUMVI.
Hepatitis B Virus (HBV) Reactivation: HBV reactivation occurred in an MS patient treated with BRIUMVI in clinical trials. Fulminant hepatitis, hepatic failure, and death caused by HBV reactivation have occurred in patients treated with anti-CD20 antibodies. Perform HBV screening in all patients before initiation of treatment with BRIUMVI. Do not start treatment with BRIUMVI in patients with active HBV confirmed by positive results for HB surface antigen (HBsAg) and anti-HB tests. For patients who are negative for HBsAg and positive for HB core antibody [HBcAb+] or are carriers of HBV [HBsAg+], consult a liver disease expert before starting and during treatment.
Progressive Multifocal Leukoencephalopathy (PML): Although no cases of PML have occurred in BRIUMVI-treated MS patients, JC virus infection resulting in PML has been observed in patients treated with other anti-CD20 antibodies and other MS therapies.
If PML is suspected, withhold BRIUMVI and perform an appropriate diagnostic evaluation. Typical symptoms associated with PML are diverse, progress over days to weeks, and include progressive weakness on one side of the body or clumsiness of limbs, disturbance of vision, and changes in thinking, memory, and orientation leading to confusion and personality changes.
MRI findings may be apparent before clinical signs or symptoms; monitoring for signs consistent with PML may be useful. Further investigate suspicious findings to allow for an early diagnosis of PML, if present. Following discontinuation of another MS medication associated with PML, lower PML-related mortality and morbidity have been reported in patients who were initially asymptomatic at diagnosis compared to patients who had characteristic clinical signs and symptoms at diagnosis.
If PML is confirmed, treatment with BRIUMVI should be discontinued.
Vaccinations: Administer all immunizations according to immunization guidelines: for live or live-attenuated vaccines, at least 4 weeks and, whenever possible, at least 2 weeks prior to initiation of BRIUMVI for non-live vaccines. BRIUMVI may interfere with the effectiveness of non-live vaccines. The safety of immunization with live or live-attenuated vaccines during or following administration of BRIUMVI has not been studied. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion.
Vaccination of Infants Born to Mothers Treated with BRIUMVI During Pregnancy: In infants of mothers exposed to BRIUMVI during pregnancy, assess B-cell counts prior to administration of live or live-attenuated vaccines as measured by CD19+ B-cells. Depletion of B-cells in these infants may increase the risks from live or live-attenuated vaccines. Inactivated or non-live vaccines may be administered prior to B-cell recovery. Assessment of vaccine immune responses, including consultation with a qualified specialist, should be considered to determine whether a protective immune response was mounted.
Fetal Risk: Based on data from animal studies, BRIUMVI may cause fetal harm when administered to a pregnant woman. Transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 B-cell depleting antibodies during pregnancy. A pregnancy test is recommended in females of reproductive potential prior to each infusion. Advise females of reproductive potential to use effective contraception during BRIUMVI treatment and for 6 months after the last dose.
Reduction in Immunoglobulins: As expected with any B-cell depleting therapy, decreased immunoglobulin levels were observed. Decrease in immunoglobulin M (IgM) was reported in
Most Common Adverse Reactions: The most common adverse reactions in RMS trials (incidence of at least
Physicians, pharmacists, or other healthcare professionals with questions about BRIUMVI should visit www.briumvi.com.
The full Summary of Product Characteristics approved in the European Union (EU) for BRIUMVI can be found here
Briumvi | European Medicines Agency (europa.eu).
ABOUT BRIUMVI PATIENT SUPPORT in the U.S.
BRIUMVI Patient Support is a flexible program designed by TG Therapeutics to support U.S. patients through their treatment journey in a way that works best for them. More information about the BRIUMVI Patient Support program can be accessed at www.briumvipatientsupport.com.
ABOUT MULTIPLE SCLEROSIS
Relapsing multiple sclerosis (RMS) is a chronic demyelinating disease of the central nervous system (CNS) and includes people with relapsing-remitting multiple sclerosis (RRMS) and people with secondary progressive multiple sclerosis (SPMS) who continue to experience relapses. RRMS is the most common form of multiple sclerosis (MS) and is characterized by episodes of new or worsening signs or symptoms (relapses) followed by periods of recovery. It is estimated that nearly 1 million people are living with MS in the United States and approximately
ABOUT TG THERAPEUTICS
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG Therapeutics has received approval from the U.S. Food and Drug Administration (FDA) for BRIUMVI® (ublituximab-xiiy) for the treatment of adult patients with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. For more information, visit www.tgtherapeutics.com, and follow us on X (formerly Twitter) @TGTherapeutics and on LinkedIn.
BRIUMVI® is a registered trademark of TG Therapeutics, Inc.
Cautionary Statement
This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission (SEC), factors that could cause our actual results to differ materially include the below.
Such forward looking statements include but are not limited to statements regarding expectations for the timing and success of the commercialization and availability of BRIUMVI® (ublituximab-xiiy) for RMS in the United States, European Union, United Kingdom, or other Ex-US territories; anticipated healthcare professional (HCP) and patient acceptance and use of BRIUMVI for the approved indications; expectations of future revenue for BRIUMVI, expenses or profits; expectations for our pipeline products; and statements regarding the results of the ENHANCE or ULTIMATE I & II Phase 3 studies.
Additional factors that could cause our actual results to differ materially include the following: the Company’s ability to maintain and continue to maintain a commercial infrastructure for BRIUMVI, and to successfully or in the timeframe projected, market and sell BRIUMVI; the risk that trends in prescriptions are not maintained or that prescriptions are not filled; the failure to obtain and maintain payor coverage; the risk that HCP interest in BRIUMVI will not be sustained; the risk that momentum in sales for BRIUMVI will not build during the course of the year; the risk that the commercialization of BRIUMVI does not continue to exceed expectations; the risk that our BRIUMVI revenue targets will not be achieved; the failure to obtain and maintain requisite regulatory approvals, including the risk that the Company fails to satisfy post-approval regulatory requirements, the potential for variation from the Company’s projections and estimates about the potential market for BRIUMVI due to a number of factors, including, further limitations that regulators may impose on the required labeling for BRIUMVI (such as modifications, resulting from safety signals that arise in the post-marketing setting or in the long-term extension study from the ULTIMATE I and II clinical trials); the Company’s ability to meet post-approval compliance obligations (on topics including but not limited to product quality, product distribution and supply chain, pharmacovigilance, and sales and marketing); the Company’s reliance on third parties for manufacturing, distribution and supply, and other support functions for our clinical and commercial products, including BRIUMVI, and the ability of the Company and its manufacturers and suppliers to produce and deliver BRIUMVI to meet the market demand for BRIUMVI; potential regulatory challenges to the Company’s plans to seek marketing approval for the product in jurisdictions outside of the U.S.; the uncertainties inherent in research and development; the risk that any individual patient’s clinical experience in the post-marketing setting, or the aggregate patient experience in the post-marketing setting, may differ from that demonstrated in controlled clinical trials such as ULTIMATE I and II; the risk that the Company does not achieve its 2025 development pipeline anticipated milestones in the timeframe projected or at all, including commencing a pivotal program for subcutaneous ublituximab, commencing a pivotal program based on data from the ENHANCE trial, enrolling patients into a trial evaluating BRIUMVI in an autoimmune disease outside of MS, or enrolling patients into a trial evaluating azer-cel; and general political, economic and business conditions. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or December 31, 2022 and in our other filings with the SEC.
Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
CONTACT:
Investor Relations
Email:ir@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 4
Media Relations:
Email:media@tgtxinc.com
Telephone: 1.877.575.TGTX (8489), Option 6
1. MS Prevalence. National Multiple Sclerosis Society website. https://www.nationalmssociety.org/About-the-Society/MS-Prevalence. Accessed October 26, 2020. 2. Multiple Sclerosis International Federation, 2013 via Datamonitor p. 236.
TG Therapeutics, Inc. | |||||||||||||
Selected Condensed Consolidated Financial Data | |||||||||||||
Statements of Operations Information (in thousands, except share and per share amounts; unaudited): | |||||||||||||
Three months ended December 31, | Twelve months ended December 31, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Revenue | |||||||||||||
Product revenue, net | |||||||||||||
License, milestone, royalty and other revenue | 834 | 15,276 | 141,657 | ||||||||||
Total revenue | 43,971 | 233,662 | |||||||||||
Costs and expenses: | |||||||||||||
Cost of revenue | 15,399 | 7,855 | 38,486 | 14,131 | |||||||||
Research and development: | |||||||||||||
Noncash compensation | 3,160 | 2,848 | 11,160 | 13,010 | |||||||||
Other research and development | 20,714 | 14,601 | 83,131 | 63,182 | |||||||||
Total research and development | 23,874 | 17,449 | 94,291 | 76,192 | |||||||||
Selling, general and administrative: | |||||||||||||
Noncash compensation | 8,788 | 6,537 | 31,381 | 24,923 | |||||||||
Other selling, general and administrative | 30,175 | 24,615 | 122,917 | 97,783 | |||||||||
Total selling, general and administrative | 38,963 | 31,152 | 154,298 | 122,706 | |||||||||
Total costs and expenses | 78,236 | 56,456 | 287,075 | 213,029 | |||||||||
Operating income | 29,949 | (12,485 | ) | 41,929 | 20,633 | ||||||||
Other expense (income): | |||||||||||||
Interest expense | 7,061 | 2,432 | 24,028 | 12,615 | |||||||||
Other income | (2,564 | ) | (891 | ) | (7,693 | ) | (5,044 | ) | |||||
Total other expense , net | 4,497 | 1,541 | 16,335 | 7,571 | |||||||||
Net income before taxes | ) | 25,594 | |||||||||||
Income tax expense | 2,122 | 390 | 2,211 | 390 | |||||||||
Net Income | ) | 23,383 | |||||||||||
Net income per common share: | |||||||||||||
Basic | ) | ||||||||||||
Diluted | ) | ||||||||||||
Weighted average shares of common stock outstanding | |||||||||||||
Basic | 145,243,472 | 143,092,594 | 145,317,418 | 141,955,112 | |||||||||
Diluted | 160,244,430 | 143,092,594 | 160,336,051 | 148,508,465 |
Condensed Balance Sheet Information (in thousands): | |||
December 31, 2024 (Unaudited) | December 31, 2023* | ||
Cash, cash equivalents and investment securities | 311,001 | 217,508 | |
Total assets | 577,690 | 329,587 | |
Total equity | 222,364 | 160,502 | |
* Condensed from audited financial statements |
