Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other ju ...

Financial Data and Key Metrics Changes - The company reported net product revenue of $7.8 million in the first quarter, exceeding internal expectations [31] - The net loss for Q1 2023 was approximately $32.6 million, down more than 50% from $67 million in Q1 2022, reflecting a disciplined spending approach [35] - GAAP net loss for Q1 2023 was $39.4 million or $0.28 per share, compared to a loss of $69 million or $0.51 per share in Q1 2022 [35] Business Line Data and Key Metrics Changes - BRIUMVI's launch has seen early adoption from both major academic centers and community practices, with over 165 physicians from more than 125 centers prescribing the drug [31][32] - The company has achieved coverage policies for over 50% of covered lives across the US, ahead of the mid-year goal [33] Market Data and Key Metrics Changes - The company anticipates an acceleration in prescriptions in the second half of the year as operational hurdles are addressed and the J-Code becomes effective on July 1, 2023 [33] - There is significant growth potential for the CD20 class in the EU, with positive discussions with key opinion leaders in Germany [9] Company Strategy and Development Direction - The company is evaluating its commercial pathway in Europe, considering either a solo launch or a partnership, with a decision expected in the coming months [29] - The company aims to achieve broad access to BRIUMVI with greater than 80% coverage by the end of 2023 [33] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in BRIUMVI's best-in-class potential and the positive reception from healthcare providers [26][28] - The company believes that operational hurdles will continue to improve throughout the year, facilitating further growth [33] Other Important Information - The company ended the quarter with approximately $160 million in cash, which is expected to last into mid-2024 based on current revenue assumptions [30][36] - The company has capitalized $25 million in inventory on the balance sheet, which will likely be the sole campaign in 2023 [15] Q&A Session Summary Question: Can you elaborate on the mix between new to CD20 versus switches? - The company is seeing a mix of both naive and switch patients, with a broad distribution from various therapies [40][41] Question: What percentage of patients are utilizing the patient access programs? - Approximately 10% to 15% of free goods were provided, primarily through the quick-start program [49] Question: What are the expectations for R&D and SG&A expenses throughout the year? - R&D is expected to remain consistent with Q1 levels, while SG&A is also anticipated to stay stable [50][51] Question: How many patients were infused in the first quarter? - The company does not have exact numbers on infusions, as they only track prescriptions that go through the hub [55][56] Question: What was the gross to net discount for this quarter? - The gross to net discount in Q1 was 77%, with expectations for fluctuations in future quarters [60]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Number 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) (State or other jurisdict ...

Financial Data and Key Metrics Changes - The GAAP net loss for the year ended December 31, 2022, was $198 million or $1.46 per share, a decrease from a net loss of $348 million or $2.63 per share in 2021, reflecting a year-over-year decrease of approximately $150 million due to streamlined efforts [32] - The GAAP net loss for Q4 2022 was approximately $53 million or $0.39 per share, down from a net loss of approximately $93 million or $0.70 per share in Q4 2021, driven by a disciplined spending approach [53] Business Line Data and Key Metrics Changes - BRIUMVI received FDA approval to treat adult patients with relapsing forms of multiple sclerosis (RMS), marking a significant milestone for the company [4] - The launch of BRIUMVI is focused on building awareness, driving utilization, and minimizing access barriers, with early feedback indicating significant interest from healthcare providers [10][12] Market Data and Key Metrics Changes - Approximately 35% of covered lives in the U.S. now have payer coverage for BRIUMVI, ahead of internal goals [13] - The company estimates that nearly 1 million Americans are living with MS, with 75,000 to 80,000 seeking new treatment each year, indicating a substantial market opportunity [24] Company Strategy and Development Direction - The company aims to achieve coverage for the majority of covered lives in the U.S. by the first half of 2023, with a long-term goal of reaching 80% to 90% coverage by the end of the year [75] - The company is investing in a mix of promotional resources, including in-person and virtual marketing, to support the launch of BRIUMVI [48] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the early launch activities of BRIUMVI, noting that initial successes are ahead of schedule and position the company for an exciting year of commercial execution [99] - The company is focused on minimizing access barriers and achieving optimal patient access to BRIUMVI, with positive early feedback from infusion centers [50][51] Other Important Information - The company ended 2022 with approximately $220 million in cash, cash equivalents, and investment securities, including $45 million of available capacity under its Hercules facility [15] - Operating expenses for 2023 are expected to average approximately $40 million to $50 million per quarter, excluding BRIUMVI inventory build [16] Q&A Session Summary Question: What is the initial dosing protocol for patients switching from other anti-CD20 therapies? - Patients switching will go through the four-hour starting dose as per label, with a switch study planned to evaluate the necessity of this protocol [36][39] Question: What percentage of patients are utilizing patient assistance programs? - A higher percentage of patients are expected to engage with assistance programs in the first half of the year, which should decrease over time as coverage improves [42] Question: What is the company's strategy regarding the European market? - The company anticipates being six to nine months behind in the European market and is evaluating whether to partner or handle it independently [60] Question: How is the sales force currently structured? - The company feels that its sales force is appropriately sized for the current opportunity, with ongoing evaluations to ensure effectiveness [79][80] Question: What is the cash position and expected R&D and G&A mix for 2023? - The cash position at the end of Q4 2022 was $220 million, with operating expenses expected to be weighted towards SG&A rather than R&D [89]

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2 Gansevoort Street, 9th Floor New York, New York 10014 ☐ TRANSITION REP ...

PART I FINANCIAL INFORMATION [Item 1 Financial Statements](index=8&type=section&id=Item%201%20Financial%20Statements) TG Therapeutics reported H1 2022 revenue of **$2.6 million** and a net loss of **$109.5 million**, reflecting a substantial accumulated deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | June 30, 2022 | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $147,073 | $298,887 | | Total current assets | $202,560 | $330,965 | | Total assets | $251,666 | $379,629 | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $43,326 | $65,384 | | Total liabilities | $122,631 | $142,476 | | Accumulated deficit | $(1,438,221) | $(1,328,698) | | Total stockholders' equity | $129,035 | $237,153 | Condensed Consolidated Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | | Total revenue | $594 | $2,610 | | Total costs and expenses | $39,535 | $108,423 | | Operating loss | $(38,941) | $(105,813) | | Net loss | $(40,510) | $(109,523) | | Basic and diluted net loss per common share | $(0.30) | $(0.81) | Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Cash Flow Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(117,805) | $(141,524) | | Net cash used in investing activities | $(33,292) | $(2,989) | | Net cash used in financing activities | $(715) | $(7,217) | | **Net decrease in cash, cash equivalents and restricted cash** | **$(151,812)** | **$(151,730)** | - The company is a biopharmaceutical firm focused on novel treatments for B-cell diseases, with its primary late-stage asset being ublituximab for relapsing forms of multiple sclerosis (RMS)[31](index=31&type=chunk) - On April 15, 2022, the company announced the voluntary withdrawal of its drug UKONIQ from sale, following the withdrawal of its BLA/sNDA submission for the U2 combination therapy in CLL/SLL[43](index=43&type=chunk)[90](index=90&type=chunk) [Item 2 Management's Discussion and Analysis of Financial Condition and Results of Operations](index=29&type=section&id=Item%202%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management shifted focus to ublituximab for RMS after UKONIQ withdrawal, reporting a **$109.5 million** net loss for H1 2022 - Following updated overall survival data for the UNITY-CLL trial, the company withdrew its BLA/sNDA for the U2 combination (ublituximab and UKONIQ) in CLL/SLL and voluntarily withdrew UKONIQ from sale for its approved indications[90](index=90&type=chunk) - The company is re-evaluating its oncology studies and has paused or closed several trials. The primary clinical-stage focus is now on ublituximab for RMS[92](index=92&type=chunk) - The FDA accepted the Biologics License Application (BLA) for ublituximab in RMS and extended the PDUFA goal date to December 28, 2022, to review a major amendment submitted by the company[94](index=94&type=chunk) Comparison of Results for the Six Months Ended June 30 (in thousands) | Metric | 2022 | 2021 | Change | | :--- | :--- | :--- | :--- | | Total Revenue | $2,610 | $2,338 | $272 | | R&D Expense | $74,916 | $107,965 | $(33,049) | | SG&A Expense | $33,247 | $60,779 | $(27,532) | | Net Loss | $(109,523) | $(169,125) | $59,602 | - The decrease in R&D expense for the six months ended June 30, 2022 was primarily due to an **$18.0 million** decrease in license milestones and a **$12.9 million** decrease in clinical trial expense, partially offset by a **$15.3 million** increase in manufacturing expense related to a one-time charge for UKONIQ batches[110](index=110&type=chunk) - As of June 30, 2022, the company had **$231.8 million** in cash, cash equivalents, and investment securities, which is believed to be sufficient to provide liquidity for more than a twelve-month period[116](index=116&type=chunk) [Item 3 Quantitative and Qualitative Disclosures About Market Risk](index=39&type=section&id=Item%203%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's market risk exposure has not materially changed since December 31, 2021 - There have been no material changes in the company's market risk exposure since the end of 2021[125](index=125&type=chunk) [Item 4 Controls and Procedures](index=39&type=section&id=Item%204%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of June 30, 2022, with no material changes in internal control - As of June 30, 2022, management concluded that the company's disclosure controls and procedures were effective[126](index=126&type=chunk) - No changes occurred during the quarter ended June 30, 2022, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[127](index=127&type=chunk) PART II OTHER INFORMATION [Item 1 Legal Proceedings](index=39&type=section&id=Item%201%20Legal%20Proceedings) A securities class action lawsuit was filed in July 2022 alleging false statements about Ublituximab and Umbralisib - A securities class action lawsuit was filed in July 2022 against the company and two officers, alleging violations of federal securities laws related to statements about Ublituximab and Umbralisib[128](index=128&type=chunk) [Item 1A Risk Factors](index=40&type=section&id=Item%201A%20Risk%20Factors) The company faces substantial risks including ublituximab regulatory approval, commercialization, capital needs, and extensive regulation [Risks Related to Drug Development and Regulatory Approval](index=40&type=section&id=Risks%20Related%20to%20Drug%20Development%20and%20Regulatory%20Approval) Future success depends on ublituximab RMS approval, a lengthy and uncertain process with risks of delays and side effects - The business will be materially harmed if the company cannot obtain regulatory approval for and commercialize its product candidates, particularly ublituximab in RMS, following the withdrawal of UKONIQ and the U2 application for CLL/SLL[131](index=131&type=chunk) - Clinical drug development is a lengthy, expensive process with an uncertain outcome. The company may experience delays or be unable to complete the development and commercialization of its product candidates[135](index=135&type=chunk) - Product candidates may cause undesirable side effects that could delay or prevent regulatory approval or limit their commercial potential if approved[148](index=148&type=chunk) - The FDA extended the PDUFA goal date for the ublituximab BLA in RMS to December 28, 2022, and there is no guarantee of approval or that further delays will not occur[153](index=153&type=chunk) [Risks Related to Commercialization](index=57&type=section&id=Risks%20Related%20to%20Commercialization) Commercialization of ublituximab faces hurdles including market acceptance, competition, pricing, and expanding operations - Even if approved, products like ublituximab in RMS may not gain market acceptance from physicians, patients, and payors, which would limit revenue[177](index=177&type=chunk) - The company faces substantial competition from numerous sources, including large pharmaceutical companies with significantly greater financial and commercialization resources[194](index=194&type=chunk) - The ability to commercialize any product successfully depends on obtaining adequate coverage and reimbursement from government and private payors, who are increasingly focused on cost containment[199](index=199&type=chunk) - The company must expand its commercialization operations to support a potential launch of ublituximab in RMS, which is expensive and risky, especially given the recent dismantling of its oncology commercial team[179](index=179&type=chunk)[180](index=180&type=chunk) [Risks Related to Our Financial Position and Need for Additional Capital](index=65&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20for%20Additional%20Capital) The company has a history of losses, requires substantial capital, and faces risks from debt covenants and dilution - The company has incurred significant operating losses since inception and anticipates continued losses. Its ability to become profitable depends on generating substantial revenue from product candidates like ublituximab[206](index=206&type=chunk)[209](index=209&type=chunk) - Substantial additional funding is required for commercialization and development efforts. Failure to raise capital when needed could force the company to delay, reduce, or eliminate programs[213](index=213&type=chunk) - The company's indebtedness under its loan agreement with Hercules could adversely affect its financial condition, as it includes restrictive covenants and is secured by substantially all of the company's assets (excluding IP)[222](index=222&type=chunk)[223](index=223&type=chunk) [Risks Related to Governmental Regulation of Pharmaceutical Industry and Legal Compliance Matters](index=71&type=section&id=Risks%20Related%20to%20Governmental%20Regulation%20of%20Pharmaceutical%20Industry%20and%20Legal%20Compliance%20Matters) The company faces risks from extensive government regulation, drug pricing, fraud and abuse laws, and data privacy compliance - The company is subject to legislative and regulatory proposals aimed at lowering prescription drug prices, which could adversely affect its ability to market products profitably[227](index=227&type=chunk)[232](index=232&type=chunk) - Relationships with customers and payors are subject to fraud and abuse laws, which could expose the company to criminal sanctions, civil penalties, and exclusion from government healthcare programs[242](index=242&type=chunk)[243](index=243&type=chunk) - Failure to comply with data privacy and security laws (such as HIPAA, CCPA, and GDPR) could result in significant penalties and operational disruptions[248](index=248&type=chunk)[251](index=251&type=chunk) [Risks Related to Our Dependence on Third Parties](index=83&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) Heavy reliance on third parties for clinical trials, manufacturing, and IP creates significant development and commercialization risks - The company relies on third-party CROs to conduct clinical trials. If these parties do not perform as required, regulatory approval and commercialization could be delayed or prevented[260](index=260&type=chunk)[262](index=262&type=chunk) - The company relies on third parties for manufacturing, including a single-source supplier (Samsung Biologics) for ublituximab. This increases the risk of supply shortages, quality issues, or cost fluctuations[268](index=268&type=chunk)[269](index=269&type=chunk) - As product candidates are in-licensed, any dispute or non-performance by licensors regarding intellectual property rights could adversely affect the ability to develop and commercialize the products[282](index=282&type=chunk) [Risks Relating to Our Intellectual Property](index=92&type=section&id=Risks%20Relating%20to%20Our%20Intellectual%20Property) Success depends on obtaining and defending IP, facing risks of patent challenges, infringement litigation, and trade secret loss - Commercial success depends on obtaining and maintaining patent and trade secret protection. If the scope of patent protection is not broad enough, competitors could develop similar drugs, impairing commercialization[290](index=290&type=chunk)[291](index=291&type=chunk) - The company may be involved in expensive and time-consuming lawsuits to protect its patents or defend against claims of infringing third-party patents, with potentially unfavorable outcomes[312](index=312&type=chunk)[318](index=318&type=chunk) - Failure to protect the confidentiality of trade secrets could harm the company's business and competitive position, as competitors could independently discover or unlawfully obtain this information[327](index=327&type=chunk) [Risks Related to Our Business Organization and Governance, Strategy, Employees and Growth Management](index=107&type=section&id=Risks%20Related%20to%20Our%20Business%20Organization%20and%20Governance%2C%20Strategy%2C%20Employees%20and%20Growth%20Management) The company relies on key personnel, faces neurology transition challenges, stock price volatility, and IT security risks - The company is highly dependent on key management and personnel and may be unable to attract and retain them, which could impede development and commercialization objectives[330](index=330&type=chunk) - The company must manage its development and expansion, particularly the shift in focus to neurology and immunology, which could disrupt operations if not handled effectively[332](index=332&type=chunk)[333](index=333&type=chunk) - Internal IT systems are vulnerable to security breaches and cyber-attacks, which could result in a material disruption of drug development programs[340](index=340&type=chunk) [Risks Related to the COVID-19 Pandemic](index=114&type=section&id=Risks%20Related%20to%20the%20COVID-19%20Pandemic) The COVID-19 pandemic poses risks to supply chain, clinical trials, and commercialization, impacting ublituximab's market acceptance - The COVID-19 pandemic could materially adversely affect business operations, including disrupting the supply chain and delaying clinical trials, if new variants circulate and restrictions are reinstated[351](index=351&type=chunk) - Concerns that B-cell targeted agents may increase the risk or severity of COVID-19 could negatively impact the clinical results, regulatory approval, labeling, and market acceptance of ublituximab[352](index=352&type=chunk) [General Risks](index=118&type=section&id=General%20Risks) The company's stock price is highly volatile, exposing it to litigation, with no dividends anticipated for stockholders - The company's stock price is highly volatile and subject to wide fluctuations, which could limit investors' ability to sell at a profit and exposes the company to securities litigation[359](index=359&type=chunk)[366](index=366&type=chunk) - The company has never paid cash dividends and does not anticipate doing so in the foreseeable future, meaning capital appreciation will be the sole source of gain for stockholders[361](index=361&type=chunk) - The military conflict between Russia and Ukraine may result in market volatility that could adversely affect the company's stock price[368](index=368&type=chunk) [Item 2 Unregistered Sales of Equity Securities and Use of Proceeds](index=121&type=section&id=Item%202%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This item is not applicable for the reporting period - Not applicable[370](index=370&type=chunk) [Item 3 Defaults of Senior Securities](index=121&type=section&id=Item%203%20Defaults%20of%20Senior%20Securities) No defaults of senior securities were reported during the period - None[371](index=371&type=chunk) [Item 4 Mine Safety Disclosures](index=121&type=section&id=Item%204%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[372](index=372&type=chunk) [Item 5 Other Information](index=121&type=section&id=Item%205%20Other%20Information) No other information was reported for the period - None[373](index=373&type=chunk) [Item 6 Exhibits](index=121&type=section&id=Item%206%20Exhibits) Exhibits include CEO and CFO certifications and iXBRL financial data filed with the quarterly report - The exhibits filed with the report include certifications from the CEO and CFO pursuant to the Sarbanes-Oxley Act of 2002 and iXBRL financial data[376](index=376&type=chunk)

TG Therapeutics, Inc. (NASDAQ:TGTX) Q2 2022 Earnings Conference Call August 8, 2022 8:30 AM ET Company Participants Jenna Bosco - Senior Vice President of Corporate Communications Adam Waldman - Chief Commercialization Officer Michael Weiss - Chairman, President & Chief Executive Officer Sean Power - Chief Financial Officer Conference Call Participants Ed White - H.C. Wainwright Eric Joseph - JPMorgan Matt Kaplan - Ladenburg Thalmann Mayank Mamtani - B. Riley Prakhar Agrawal - Cantor Fitzgerald Operator Gre ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Exact name of registrant as specified in its charter) Delaware 36-3898269 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 2 Ganse ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021. OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________. Commission File Number 1-32639 TG THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 36-3898269 (Stat ...

Financial Data and Key Metrics Changes - The company ended 2021 with over $350 million in cash, cash equivalents, and investment securities, strengthening its balance sheet [9][32] - Net product revenue for UKONIQ in Q4 was $2.3 million, bringing the full year 2021 net revenue to $6.5 million [33][34] - The net loss for Q4 2021, excluding noncash items, was approximately $79 million, an increase of $7 million from Q3 2021 [33][34] - The GAAP net loss for the full year 2021 was $348.1 million, compared to $279.4 million for 2020 [36] Business Line Data and Key Metrics Changes - UKONIQ saw a 14% growth in net sales in Q4, with overall demand increasing by 25% quarter-over-quarter [24][25] - The prescriber base for UKONIQ continues to grow, with 65% of new patient starts occurring in the community setting [25][26] - The company completed enrollment of approximately 165 CLL patients into the ultra V phase II trial and launched the phase III portion of that study [11] Market Data and Key Metrics Changes - The company reported strong engagement with healthcare providers regarding UKONIQ, with positive feedback on its differentiation and economic performance [25][26] - The market for ublituximab in relapsing forms of MS is seen as dynamic, with the potential for significant impact due to its clinical profile [14][30] Company Strategy and Development Direction - The company is focused on preparing for the potential launches of U2 for CLL and ublituximab for RMS in 2022 [87] - The strategy includes optimizing account segmentation and solidifying relationships in the hematology community [27] - The company aims to leverage insights from the UKONIQ launch to ensure a successful launch for U2 CLL [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of ublituximab in RMS, highlighting its low annualized relapse rate and shorter infusion time as competitive advantages [30] - The company is preparing for an upcoming ODAC meeting and is optimistic about obtaining a favorable outcome for U2 [86] - Management noted that the FDA is taking the review process seriously and is working hard to find the truth regarding the data submitted [57] Other Important Information - The company provided free drugs to about 37% of UKONIQ-treated patients through its Patient Support Program [24] - The company is actively engaging with payers to refine its pricing strategy for ublituximab [80] Q&A Session Summary Question: Can you provide more thoughts on the size of the salesforce for MS commercialization? - The salesforce is expected to be between 80 and 100 people, focusing on concentrated centers across the U.S. [41][43] Question: What are the anticipated confirmatory trials for follicular and marginal zone? - Discussions with the FDA are ongoing, and a trial design is being finalized [46] Question: Can you clarify the access data regarding neutralizing antibodies? - The data is similar to existing CD20s, with no anticipated impact on safety or efficacy [50][51] Question: What kind of evidence is the FDA looking for regarding the upcoming panel? - The company believes the FDA is looking for the truth and is reviewing the data carefully [57] Question: How will the FDA handle the new OS data submitted? - The FDA may consider the new data as a major amendment, potentially pushing the PDUFA date back [72] Question: What are the latest thoughts on the 2025 revenue guidance of $1 billion? - The guidance remains open until the outcomes of the ODAC and FDA decisions are known [63] Question: What is the strategy for the European market for MS? - A small team is evaluating the European opportunity, with timing expected to be six months post-U.S. approval [67]