Financial Performance - TG Therapeutics reported first-quarter earnings per share of 3 cents, a shift from a loss of 7 cents a year ago, but below the consensus of 17 cents [1] - The company reported sales of $120.86 million, up from $63.47 million a year ago, beating the consensus of $118.43 million [1] Product Performance - Briumvi's U.S. net sales reached $119.7 million, demonstrating growing confidence in the treatment and increasing adoption by healthcare providers [2][3] - The company presented five-year data from the ULTIMATE I & II Phase 3 trials, showing that 92% of patients were free from disability progression after five years, with an annualized relapse rate of 0.02 during year 5 [4] - No new safety signals emerged over five years of continuous treatment, with no observed cases of progressive multifocal leukoencephalopathy (PML) [4] Future Guidance - TG Therapeutics raised Briumvi's U.S. net product revenue target to $560 million for fiscal 2025 from $525 million in prior guidance [5] - The total global revenue target was raised to $575 million from prior guidance of $540 million [5] - Briumvi's U.S. net product revenue is expected to be $135 million in the second quarter of 2025 [5] Stock Performance - TGTX stock was down 13.2% at $37.68 on Monday [6]

Core Insights - TG Therapeutics reported a significant increase in revenue and achieved profitability, but the stock price fell sharply due to investor disappointment [1][4][7] Revenue Performance - The company's revenue for the first quarter was nearly $121 million, almost double the $63.5 million from the same period in 2024, driven primarily by Briumvi sales [2][6] - Analysts had a collective revenue estimate of $117 million, indicating that the actual revenue exceeded expectations [4] Profitability - TG Therapeutics posted a net profit of just over $5 million, or $0.03 per share, compared to an almost $11 million loss in the first quarter of 2024 [4] - The consensus estimate for earnings per share was $0.16, suggesting that the actual profit fell short of analyst expectations [4][7] Pipeline Developments - The company is conducting two phase 1 trials for Briumvi: one for subcutaneous use in relapsing MS patients and another for myasthenia gravis [5] - Additionally, TG is developing a CAR T cell therapy, azercabtagene zapreleucel, which is currently in enrollment for a phase 1 trial [5] Guidance Update - TG Therapeutics raised its guidance for domestic Briumvi sales in 2025 to $560 million, up from a previous estimate of $525 million [6] - Overall revenue guidance was also increased to $575 million from $540 million [6]

Company Overview - TG Therapeutics, Inc. is a commercial stage pharmaceutical company based in Morrisville, North Carolina, known for marketing and selling Briumvi (ublituximab), which was approved in the US in 2022 for treating relapsing forms of multiple sclerosis (rMS) [2]. Market Position and Offerings - The company provides a platform for both novice and experienced biotech investors, offering insights on catalysts, buy and sell ratings, product sales forecasts, and integrated financial statements [2]. Analyst Insights - Edmund Ingham, a biotech consultant with over 5 years of experience in the sector, has compiled detailed reports on more than 1,000 companies and leads the investing group Haggerston BioHealth [2].

Financial Data and Key Metrics Changes - U.S. net sales for BRIONVI reached approximately $119.7 million in Q1 2025, reflecting a 137% year-over-year growth and a 16% sequential increase from Q4 2024 [16][24] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [25] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [26] Business Line Data and Key Metrics Changes - BRIONVI's U.S. net sales exceeded internal expectations, marking the highest months of total new patient enrollment since launch, with March being the highest month for repeat prescribers [16][18] - The company reported that repeat prescriptions have now surpassed new prescriptions for the first time, indicating strong persistence trends [18] Market Data and Key Metrics Changes - The company is gaining approximately 25% of the IV segment market share, with no observed impact from competitive products like OCREVUS [30][31] - The hospital setting contributed approximately 60% of enrollments in March, highlighting a deepening footprint among institutional accounts [18] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy, focusing on a multi-phase launch strategy and enhancing the patient experience [9][13] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation of BRIONVI [20][22] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand, increasing prescriber confidence, and broad commercial execution [21][22] - The company is actively monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The company is advancing its pipeline with a focus on the ENHANCE clinical trial and exploring new indications for subcutaneous BREONVY [10][12] - The company is also excited about its allogeneic CD19 CAR T cell therapy, azurecel, targeting progressive forms of MS [13] Q&A Session Summary Question: Competitive dynamics regarding OCREVUS and new patient share - Management noted that they are seeing strong market share gains and have not observed any impact from OCREVUS [30][31] Question: Update on gross to net trends and gross margin expectations - There was no material change in gross to net for the quarter, and the margins reported are expected to be consistent going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data likely to be available later this year [42][44] Question: Feedback on the thirty-minute infusion data - Positive feedback was received from physicians regarding the thirty-minute infusion, which is seen as a convenience for busy infusion centers [50] Question: Update on North Carolina plant for commercial scale manufacturing - The North Carolina facility will take several years to be operational for commercial manufacturing [58] Question: Product adherence metrics - Persistence trends remain strong and above expectations, although specific adherence metrics were not disclosed [64] Question: Percentage of BRIONVI patients switching from OCREVUS - The company has not seen material changes in the percentage of switches from OCREVUS, maintaining a healthy amount of switches since launch [71]

Company Performance - TG Therapeutics reported quarterly earnings of $0.03 per share, missing the Zacks Consensus Estimate of $0.18 per share, compared to a loss of $0.07 per share a year ago, representing an earnings surprise of -83.33% [1] - The company posted revenues of $120.86 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 1.99%, and showing a significant increase from year-ago revenues of $63.47 million [2] - Over the last four quarters, TG Therapeutics has surpassed consensus EPS estimates two times and topped consensus revenue estimates four times [2] Stock Performance - TG Therapeutics shares have increased approximately 44.3% since the beginning of the year, while the S&P 500 has declined by -3.3% [3] - The current consensus EPS estimate for the coming quarter is $0.22 on revenues of $131.03 million, and for the current fiscal year, it is $0.98 on revenues of $545.6 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which TG Therapeutics belongs, is currently in the top 34% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, suggesting that industry performance can significantly impact stock performance [5][8]

Financial Data and Key Metrics Changes - U.S. net product revenue for Q1 2025 was approximately $119.7 million, reflecting a 137% increase year-over-year and a 16% increase sequentially from Q4 2024 [14][23] - GAAP net income for the quarter was approximately $5 million, or $0.03 per diluted share [24] - The company closed the quarter with $276 million in cash, cash equivalents, and investment securities, indicating a strong financial position [24] Business Line Data and Key Metrics Changes - BRIONVI U.S. net sales reached nearly $120 million in Q1 2025, exceeding expectations and demonstrating strong adoption by healthcare providers [5][14] - The first three months of 2025 marked the highest total new patient enrollment since the product launch, indicating accelerating demand [15] - Repeat prescriptions have now surpassed new prescriptions for the first time, signaling strong persistence trends [17] Market Data and Key Metrics Changes - The company is capturing approximately 25% of the IV segment market share, with continued growth in patient enrollments [29] - The hospital setting contributed approximately 60% of enrollments in March, the highest percentage to date [16] Company Strategy and Development Direction - The company aims to make BRIONVI the number one prescribed anti-CD20 therapy by focusing on a multi-phase launch strategy and enhancing the patient experience [8][12] - Plans include launching a direct-to-patient television commercial campaign and preparing for lifecycle innovations, including a subcutaneous formulation [19][21] - The company is also exploring new indications for BRIONVI, such as myasthenia gravis, while advancing its CAR T cell therapy pipeline [11][12] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about continued growth and potential for BRIONVI, citing strong demand and increasing prescriber confidence [20][21] - The company is monitoring potential tariffs but does not anticipate a material impact on gross margins or overall financial performance [26] Other Important Information - The ENHANCE clinical trial is evaluating strategies to simplify the patient experience, with positive feedback on a streamlined infusion regimen [9][10] - The company is on track to launch pivotal trials for both the simplified starting dose and the subcutaneous formulation of BREONVY [52][68] Q&A Session Summary Question: Competitive dynamics with OCREVUS and new patient share - Management noted strong patient enrollments and market share gains, with no impact from OCREVUS observed [29][30] Question: Update on gross to net trends and gross margin - No material change in gross to net was reported, and the pre-launch inventory reserve has been fully depleted, leading to consistent margins going forward [37][38] Question: Subcutaneous BREONVY pivotal trial details - The pivotal trial is expected to include two dosing regimens, with data anticipated later this year [41][42] Question: Physician feedback on the thirty-minute infusion - Positive feedback was received, indicating convenience for infusion centers and patients [49] Question: Phase III trial scale and profitability outlook - The company is not focused on profitability this year but aims to drive cash through the business while meeting revenue targets [54][55] Question: Update on North Carolina manufacturing plant - The North Carolina facility will take several years to reach commercial scale manufacturing [57][58] Question: Product adherence and trends - Persistence trends remain strong and above expectations, with no material changes in switch rates from OCREVUS [63][71]

Financial Performance - BRIUMVI U.S. net product revenue for Q1 2025 was $119.7 million, representing approximately 137% growth year-over-year[5] - The company raised its full year 2025 global net revenue target to approximately $575 million, up from prior guidance of $540 million[8] - The U.S. net revenue target for BRIUMVI for the full year 2025 was raised to approximately $560 million, compared to the previous target of $525 million[8] - TG Therapeutics reported total revenue of $120.856 million for the three months ended March 31, 2025, a 90.5% increase from $63.474 million in the same period of 2024[41] - Product revenue, net for the same period was $119.655 million, compared to $50.488 million in the prior year, reflecting a significant growth of 137.4%[41] - The company achieved an operating profit of $8.622 million in Q1 2025, compared to an operating loss of $9.270 million in Q1 2024[41] - Net income for the first quarter of 2025 was $5.060 million, a turnaround from a net loss of $10.707 million in the same quarter of 2024[41] Expenses - Total research and development (R&D) expenses for Q1 2025 were $46.4 million, an increase from $32.7 million in Q1 2024[8] - Selling, general and administrative (SG&A) expenses for Q1 2025 were $50.3 million, compared to $34.6 million in Q1 2024[8] Cash and Assets - Cash, cash equivalents, and investment securities were $276.2 million as of March 31, 2025, expected to fund operations based on the current plan[8] - Cash, cash equivalents, and investment securities totaled $276.240 million as of March 31, 2025, down from $311.001 million at the end of 2024[42] - Total assets increased to $656.689 million as of March 31, 2025, compared to $577.690 million at the end of 2024[42] - Total equity rose to $237.288 million as of March 31, 2025, up from $222.364 million at the end of 2024[42] Product Development and Commercialization - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland[5] - The company is advancing the development of subcutaneous BRIUMVI and azer-cel for progressive MS[2] - A pivotal program for subcutaneous BRIUMVI is set to commence, along with a program based on improved dosing regimens evaluated in the ENHANCE trial[8] - The company is focused on the commercialization of BRIUMVI® (ublituximab-xiiy) for relapsing forms of multiple sclerosis, with approvals in the U.S., EU, UK, and Switzerland[32] Future Outlook - Future revenue expectations for BRIUMVI are contingent on healthcare professional and patient acceptance, as well as maintaining prescription trends[36] - TG Therapeutics anticipates achieving key development milestones for its pipeline products by 2025, including pivotal programs for subcutaneous ublituximab[37]

Financial Performance - TG Therapeutics reported U.S. net revenue of $119.7 million for BRIUMVI in the first quarter of 2025, representing approximately 137% growth compared to the same period last year [5][9] - The company raised its full-year 2025 global net revenue target to approximately $575 million, up from a prior guidance of $540 million, and increased the U.S. net revenue target for BRIUMVI to approximately $560 million from $525 million [1][10] - The net income for the first quarter of 2025 was $5.1 million, compared to a net loss of $10.7 million for the same period in 2024 [9][41] Product Development and Commercialization - BRIUMVI is experiencing growing adoption among healthcare providers, with positive feedback from both patients and clinicians, reinforcing the company's goal of making BRIUMVI the number one prescribed anti-CD20 treatment [2][5] - The company is investing in innovation, including simplifying the BRIUMVI treatment regimen and advancing subcutaneous BRIUMVI [2][5] - BRIUMVI is now commercially available in additional countries in the European Union, United Kingdom, and Switzerland, expanding its market presence [5][10] Clinical Trials and Research - Five-year data from the ULTIMATE I & II Phase 3 clinical trials showed that 92% of patients were free from disability progression after five years of treatment with BRIUMVI [5] - Ongoing clinical trials include a Phase 1 trial evaluating subcutaneous BRIUMVI and another for azer-cel in patients with primary progressive multiple sclerosis [6][10] - The ENHANCE Phase 3b clinical trial demonstrated that a single 600 mg BRIUMVI infusion was well tolerated, and rapid 30-minute infusions were also well received by patients [5][10] Financial Guidance and Future Outlook - The company anticipates a second quarter 2025 U.S. net product revenue target of $135 million and expects total operating expenses for the full year 2025 to be approximately $300 million [10][41] - TG Therapeutics plans to commence pivotal programs for subcutaneous BRIUMVI and based on improved dosing regimens evaluated in the ENHANCE trial [10][41] - The company aims to continue enrollment in ongoing clinical trials for BRIUMVI in autoimmune diseases outside of multiple sclerosis [10][41]

Core Points - TG Therapeutics, Inc. will hold a conference call on May 5, 2025, at 8:30 AM ET to discuss Q1 2025 results and provide a business outlook for the remainder of the year [1] - The call will be hosted by Michael S. Weiss, Chairman and CEO of the company [1] - A press release with financial results will be issued prior to the conference call [3] Company Overview - TG Therapeutics is a biopharmaceutical company focused on the acquisition, development, and commercialization of novel treatments for B-cell diseases [4] - The company has received FDA approval for BRIUMVI® (ublituximab-xiiy) for treating adult patients with relapsing forms of multiple sclerosis [4] - BRIUMVI has also been approved by the European Commission and the Medicines and Healthcare Products Regulatory Agency for similar indications in Europe and the UK [4]

Core Insights - TG Therapeutics, Inc. (TGTX) shares have increased by 29.5% over the past three months, contrasting with an 11.2% decline in the industry [1] - The company's primary revenue source is from its marketed drug Briumvi, which has exceeded sales expectations in 2024 [1][2] Group 1: Briumvi Performance - Briumvi's net product sales reached $313.7 million in 2024, a significant increase from $92 million in 2023 [2] - The strong sales performance of Briumvi is a key factor driving the stock's increase [2] - TG Therapeutics anticipates worldwide revenues of approximately $540 million in 2025, with nearly $525 million expected from Briumvi sales in the U.S. [3] Group 2: Patent and Development Updates - The company has secured three additional patents for Briumvi, extending its patent protection until 2042, which will help safeguard against generic competition [3] - TG Therapeutics is developing a self-administered subcutaneous formulation of Briumvi, with a phase I study already initiated for patients with relapsing forms of multiple sclerosis [4] Group 3: Pipeline and Future Prospects - TG Therapeutics entered a licensing agreement with Precision BioSciences for the allogeneic CD19 CAR T therapy, azercabtagene zapreleucel, aimed at treating certain autoimmune disorders [7] - The FDA has cleared the investigational new drug application for azer-cel for progressive forms of multiple sclerosis, with participant enrollment in the phase I study expected to begin soon [7][8] - The combination of strong Briumvi adoption and positive pipeline developments is expected to continue driving TGTX stock performance in 2025 [8]