TG Therapeutics TGTX
eröffnet am 13.07.20 10:32:08 von
neuester Beitrag 18.04.24 14:04:48 von
neuester Beitrag 18.04.24 14:04:48 von
Beiträge: 467
ID: 1.327.694
ID: 1.327.694
Aufrufe heute: 3
Gesamt: 37.897
Gesamt: 37.897
Aktive User: 0
ISIN: US88322Q1085 · WKN: A1JXW7 · Symbol: TGTX
13,470
USD
-3,16 %
-0,440 USD
Letzter Kurs 02:00:00 Nasdaq
Neuigkeiten
18.04.24 · globenewswire  |
18.04.24 · globenewswire |
15.04.24 · globenewswire |
08.03.24 · globenewswire |
Werte aus der Branche Pharmaindustrie
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,9000 | +305,04 | |
| 1,3254 | +82,86 | |
| 0,6500 | +25,75 | |
| 6,0000 | +25,00 | |
| 56,69 | +20,00 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 2,1200 | -12,17 | |
| 8,5000 | -15,00 | |
| 0,7300 | -18,59 | |
| 92,06 | -19,84 | |
| 2,7280 | -29,14 |
Beitrag zu dieser Diskussion schreiben
Feedback
TG Therapeutics Announces Additional Data Presentations for BRIUMVI® (ublituximab-xiiy) in Multiple Sclerosis at the American Academy of Neurology 2024 Annual Meeting
TG Therapeutics Awarded National Contract by the Department of Veterans Affairs for BRIUMVI as the Preferred Anti-CD20 for Relapsing Forms of Multiple Sclerosis
Apr 18, 2024
PDF Version
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS).
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We are immensely proud to collaborate with the National VA Health System in bringing BRIUMVI to Veterans across the country afflicted with RMS at a significant discount. We believe this contract signifies a vote of confidence in the value that BRIUMVI brings to patients with RMS and are pleased that Veterans with MS will now have access to the only anti-CD20 therapy that offers a one-hour twice a year therapy, following the first dose.”
The contract period includes the base year ordering period of June 17, 2024 to June 16, 2025, as well as four one-year option periods that may be exercised unilaterally by the U.S. Government. Pursuant to the contract, BRIUMVI will be required for new patient starts unless clinically contraindicated. While not required, patients currently prescribed other agents in the anti-CD20 class may be switched over to BRIUMVI at the discretion of their doctor. The total award amount of the contract has a potential value of $186,776,520. This potential value assumes all MS patients estimated to be treated with anti-CD20 therapies by the VA annually, are treated with BRIUMVI each year for a five-year period at the contract price.
Apr 18, 2024
PDF Version
NEW YORK, April 18, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), announced that it has been awarded a national contract with the Department of Veterans Affairs (VA) for BRIUMVI® (ublituximab-xiiy) to be the preferred agent listed on the VA National Formulary for Anti-CD20 Antibody indications for patients with relapsing forms of multiple sclerosis (RMS).
Michael S. Weiss, Chief Executive Officer and Chairman of TG Therapeutics stated, “We are immensely proud to collaborate with the National VA Health System in bringing BRIUMVI to Veterans across the country afflicted with RMS at a significant discount. We believe this contract signifies a vote of confidence in the value that BRIUMVI brings to patients with RMS and are pleased that Veterans with MS will now have access to the only anti-CD20 therapy that offers a one-hour twice a year therapy, following the first dose.”
The contract period includes the base year ordering period of June 17, 2024 to June 16, 2025, as well as four one-year option periods that may be exercised unilaterally by the U.S. Government. Pursuant to the contract, BRIUMVI will be required for new patient starts unless clinically contraindicated. While not required, patients currently prescribed other agents in the anti-CD20 class may be switched over to BRIUMVI at the discretion of their doctor. The total award amount of the contract has a potential value of $186,776,520. This potential value assumes all MS patients estimated to be treated with anti-CD20 therapies by the VA annually, are treated with BRIUMVI each year for a five-year period at the contract price.
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results
2023 Highlights & Recent Developments
United States (U.S.) Commercialization of BRIUMVI® (ublituximab-xiiy)
- BRIUMVI U.S. net product revenue of $39.9 million and $88.8 million for the fourth quarter and full year of 2023, respectively
- Approximately 3200 BRIUMVI prescriptions received by the TG Therapeutics hub since launch, from approximately 640 healthcare providers at approximately 400 centers
European Commercialization of BRIUMVI
- Received European Commission (EC) approval of BRIUMVI, for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have active disease defined by clinical or imaging features
- Announced an agreement with Neuraxpharm Group (Neuraxpharm) for the ex-U.S. commercialization of BRIUMVI in RMS
- Received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the United Kingdom (UK)
- Launched BRIUMVI in the first European country, Germany, with our partner, Neuraxpharm
General Business
- Year-end 2023 cash position of $217.5 million
- 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 all other non-oncology indications
- Presented the first data from the ENHANCE Phase 3b trial evaluating patients who switch from another CD20 antibody to BRIUMVI
- Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042
2024 Target BRIUMVI Guidance
- BRIUMVI U.S. net product revenue target of approximately $220 million to $260 million for the full year 2024
- Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones
- Commence clinical development of subcutaneous BRIUMVI
- Commence a trial evaluating BRIUMVI in an additional autoimmune disease outside of multiple sclerosis (MS)
- Commence a trial evaluating azer-cel in autoimmune disease
- Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
Financial Results for Fourth Quarter and Full Year 2023
- Product Revenue, net: Product revenue, net includes net product sales of BRIUMVI in the U.S. of $39.9 million and $88.8 million for the three and twelve months ended December 31, 2023, respectively. Also included in product revenue, net for the three and twelve months ended December 31, 2023 is $3.2 million of BRIUMVI product revenue for product sold to Neuraxpharm in support of that commercial launch. Product revenue, net for the three and twelve months ended December 31, 2022, consisted of net product sales of UKONIQ™ (umbralisib), which was withdrawn from the U.S. market in May of 2022.
- License, Milestones and Other Revenue: License, milestone and other revenue was approximately $0.8 million and $141.7 million for the three and twelve months ended December 31, 2023, respectively, compared to less than $0.1 million and $0.2 million for the three and twelve months ended December 31, 2022, respectively. License, milestone, and other revenue for the twelve months ended December 31, 2023, is primarily related to the $140.0 million one-time payment received from Neuraxpharm in July 2023 upon execution of the agreement for the ex-U.S. commercialization of BRIUMVI in RMS.
- R&D Expenses: Total research and development (R&D) expense was $17.4 million and $76.2 million for the three and twelve months ended December 31, 2023, respectively, compared to $29.6 million and $125.4 million for the three and twelve months ended December 31, 2022, respectively. The decrease in R&D expense is primarily attributable to reduced clinical trial related expenses, license milestones, manufacturing expense, and lower fees paid to consultants and outside service providers during the twelve months ended December 31, 2023, over the comparable period in 2022. Prior to the approval of BRIUMVI, manufacturing costs pertaining to BRIUMVI were expensed to R&D expense in the period incurred, and following approval are reflected in inventory.
- SG&A Expenses: Total selling, general and administrative (SG&A) expense was $31.2 million and $122.7 million for the three and twelve months ended December 31, 2023, respectively, and $22.5 million and $70.0 million for the three and twelve months ended December 31, 2022, respectively. The increase was primarily due to non-cash compensation SG&A expenses incurred, and other costs, including personnel and consultants, associated with the commercialization of BRIUMVI during the three and twelve months ended December 31, 2023.
- Net Loss/Net Income: Net loss was $14.4 million for the three months ended December 31, 2023 and net income was $12.7 million for the twelve months ended December 31, 2023, compared to net loss of $53.0 million and $198.3 million for the three and twelve months ended December 31, 2022, respectively.
- Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $217.5 million as of December 31, 2023. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2023, combined with projected revenues from BRIUMVI, will be sufficient to fund the Company’s planned operations into cash flow positivity based on the current operating plan.
TG Therapeutics Provides Business Update and Reports Fourth Quarter and Year-End 2023 Financial Results
2023 Highlights & Recent Developments
United States (U.S.) Commercialization of BRIUMVI® (ublituximab-xiiy)
- BRIUMVI U.S. net product revenue of $39.9 million and $88.8 million for the fourth quarter and full year of 2023, respectively
- Approximately 3200 BRIUMVI prescriptions received by the TG Therapeutics hub since launch, from approximately 640 healthcare providers at approximately 400 centers
European Commercialization of BRIUMVI
- Received European Commission (EC) approval of BRIUMVI, for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) who have active disease defined by clinical or imaging features
- Announced an agreement with Neuraxpharm Group (Neuraxpharm) for the ex-U.S. commercialization of BRIUMVI in RMS
- Received approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS with active disease defined by clinical or imaging features in the United Kingdom (UK)
- Launched BRIUMVI in the first European country, Germany, with our partner, Neuraxpharm
General Business
- Year-end 2023 cash position of $217.5 million
- 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 all other non-oncology indications
- Presented the first data from the ENHANCE Phase 3b trial evaluating patients who switch from another CD20 antibody to BRIUMVI
- Obtained three additional patents from the United States Patent and Trademark Office (USPTO) for BRIUMVI, extending patent protection through 2042
2024 Target BRIUMVI Guidance
- BRIUMVI U.S. net product revenue target of approximately $220 million to $260 million for the full year 2024
- Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones
- Commence clinical development of subcutaneous BRIUMVI
- Commence a trial evaluating BRIUMVI in an additional autoimmune disease outside of multiple sclerosis (MS)
- Commence a trial evaluating azer-cel in autoimmune disease
- Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
Financial Results for Fourth Quarter and Full Year 2023
- Product Revenue, net: Product revenue, net includes net product sales of BRIUMVI in the U.S. of $39.9 million and $88.8 million for the three and twelve months ended December 31, 2023, respectively. Also included in product revenue, net for the three and twelve months ended December 31, 2023 is $3.2 million of BRIUMVI product revenue for product sold to Neuraxpharm in support of that commercial launch. Product revenue, net for the three and twelve months ended December 31, 2022, consisted of net product sales of UKONIQ™ (umbralisib), which was withdrawn from the U.S. market in May of 2022.
- License, Milestones and Other Revenue: License, milestone and other revenue was approximately $0.8 million and $141.7 million for the three and twelve months ended December 31, 2023, respectively, compared to less than $0.1 million and $0.2 million for the three and twelve months ended December 31, 2022, respectively. License, milestone, and other revenue for the twelve months ended December 31, 2023, is primarily related to the $140.0 million one-time payment received from Neuraxpharm in July 2023 upon execution of the agreement for the ex-U.S. commercialization of BRIUMVI in RMS.
- R&D Expenses: Total research and development (R&D) expense was $17.4 million and $76.2 million for the three and twelve months ended December 31, 2023, respectively, compared to $29.6 million and $125.4 million for the three and twelve months ended December 31, 2022, respectively. The decrease in R&D expense is primarily attributable to reduced clinical trial related expenses, license milestones, manufacturing expense, and lower fees paid to consultants and outside service providers during the twelve months ended December 31, 2023, over the comparable period in 2022. Prior to the approval of BRIUMVI, manufacturing costs pertaining to BRIUMVI were expensed to R&D expense in the period incurred, and following approval are reflected in inventory.
- SG&A Expenses: Total selling, general and administrative (SG&A) expense was $31.2 million and $122.7 million for the three and twelve months ended December 31, 2023, respectively, and $22.5 million and $70.0 million for the three and twelve months ended December 31, 2022, respectively. The increase was primarily due to non-cash compensation SG&A expenses incurred, and other costs, including personnel and consultants, associated with the commercialization of BRIUMVI during the three and twelve months ended December 31, 2023.
- Net Loss/Net Income: Net loss was $14.4 million for the three months ended December 31, 2023 and net income was $12.7 million for the twelve months ended December 31, 2023, compared to net loss of $53.0 million and $198.3 million for the three and twelve months ended December 31, 2022, respectively.
- Cash Position and Financial Guidance: Cash, cash equivalents and investment securities were $217.5 million as of December 31, 2023. We anticipate that our cash, cash equivalents and investment securities as of December 31, 2023, combined with projected revenues from BRIUMVI, will be sufficient to fund the Company’s planned operations into cash flow positivity based on the current operating plan.
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)
Feb 27, 2024
PDF Version
NEWLY ISSUED PATENTS EXTEND EXCLUSIVITY OF UBLITUXIMAB THROUGH 2042
NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the first and only anti-CD20 monoclonal antibody approved in the US for patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion following the starting dose.
The additional recently issued patents, US Patent Nos. 11,807,689; 11,814,439; and 11,884,740, leverage the unique glycoprofile of ublituximab to extend patent protection covering the composition of matter of ublituximab and methods of treatment utilizing ublituximab into 2042.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are pleased to announce the issuance of these additional patents for BRIUMVI which add to our existing patent portfolio, and extend patent protection through 2042. Life cycle management is of the utmost importance, and we believe these additional patents will provide a long runway to continue to explore the full potential of BRIUMVI, including expanding the potential reach of BRIUMVI in multiple sclerosis as well as in other autoimmune indications.”
BRIUMVI is currently approved and commercially available in the US for patients with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI has also been approved by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively, and is commercially available in Germany.
TG Therapeutics Announces Issuance of Additional Patents for BRIUMVI® (ublituximab-xiiy)
Feb 27, 2024
PDF Version
NEWLY ISSUED PATENTS EXTEND EXCLUSIVITY OF UBLITUXIMAB THROUGH 2042
NEW YORK, Feb. 27, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG) today announced the issuance of three additional patents by the United States Patent and Trademark Office (USPTO) for BRIUMVI® (ublituximab-xiiy), the first and only anti-CD20 monoclonal antibody approved in the US for patients with relapsing forms of multiple sclerosis (RMS) that can be administered in a one-hour infusion following the starting dose.
The additional recently issued patents, US Patent Nos. 11,807,689; 11,814,439; and 11,884,740, leverage the unique glycoprofile of ublituximab to extend patent protection covering the composition of matter of ublituximab and methods of treatment utilizing ublituximab into 2042.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We are pleased to announce the issuance of these additional patents for BRIUMVI which add to our existing patent portfolio, and extend patent protection through 2042. Life cycle management is of the utmost importance, and we believe these additional patents will provide a long runway to continue to explore the full potential of BRIUMVI, including expanding the potential reach of BRIUMVI in multiple sclerosis as well as in other autoimmune indications.”
BRIUMVI is currently approved and commercially available in the US for patients with RMS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI has also been approved by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively, and is commercially available in Germany.
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy)
Feb 26, 2024
PDF Version
EX-US PARTNER, NEURAXPHARM, LAUNCHES BRIUMVI IN GERMANY, THE FIRST EUROPEAN COUNTRY
NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG Therapeutics) today announced that its ex-US partner, Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, launched BRIUMVI® (ublituximab-xiiy) in Europe, for the treatment of adults patients with relapsing forms of multiple sclerosis (RMS), who have active disease defined by clinical or imaging features. The launch commenced in Germany, with additional launches throughout Europe to follow. In accordance with the ex-US commercialization agreement, TG Therapeutics will receive a milestone payment of $12.5 million for the first launch of BRIUMVI in a European country.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We want to congratulate our partner, Neuraxpharm, on the official launch of BRIUMVI in Europe. This is an exciting day for patients in Europe with RMS, and we look forward to sharing additional updates as the European launch progresses.”
BRIUMVI is currently approved and commercially available in the US for patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI has also been approved by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat adult patients with RMS who have active disease defined by clinical or imaging features in the European Union (EU) and the United Kingdom (UK), respectively. TG Therapeutics entered into an agreement with Neuraxpharm (the commercialization agreement) for the ex-US commercialization of BRIUMVI® in August 2023.
TG Therapeutics Announces European Launch of BRIUMVI® (ublituximab-xiiy)
Feb 26, 2024
PDF Version
EX-US PARTNER, NEURAXPHARM, LAUNCHES BRIUMVI IN GERMANY, THE FIRST EUROPEAN COUNTRY
NEW YORK, Feb. 26, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) (TG Therapeutics) today announced that its ex-US partner, Neuraxpharm Group (Neuraxpharm), a leading European specialty pharmaceutical company focused on the treatment of central nervous system (CNS) disorders, launched BRIUMVI® (ublituximab-xiiy) in Europe, for the treatment of adults patients with relapsing forms of multiple sclerosis (RMS), who have active disease defined by clinical or imaging features. The launch commenced in Germany, with additional launches throughout Europe to follow. In accordance with the ex-US commercialization agreement, TG Therapeutics will receive a milestone payment of $12.5 million for the first launch of BRIUMVI in a European country.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics, stated, “We want to congratulate our partner, Neuraxpharm, on the official launch of BRIUMVI in Europe. This is an exciting day for patients in Europe with RMS, and we look forward to sharing additional updates as the European launch progresses.”
BRIUMVI is currently approved and commercially available in the US for patients with RMS, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. BRIUMVI has also been approved by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) to treat adult patients with RMS who have active disease defined by clinical or imaging features in the European Union (EU) and the United Kingdom (UK), respectively. TG Therapeutics entered into an agreement with Neuraxpharm (the commercialization agreement) for the ex-US commercialization of BRIUMVI® in August 2023.
Trading Spotlight
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2023 Financial Results and Business Update
Feb 23, 2024
PDF Version
CONFERENCE CALL TO BE HELD WEDNESDAY, FEBRUARY 28, 2024, AT 8:30 AM ET
NEW YORK, Feb. 23, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held on Wednesday, February 28, 2024, at 8:30 AM ET to discuss results for the fourth quarter and year-end 2023 and provide a business outlook for 2024. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call.
In order 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 Fourth Quarter and Year End Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.
TG Therapeutics to Host Conference Call on Fourth Quarter and Year-End 2023 Financial Results and Business Update
Feb 23, 2024
PDF Version
CONFERENCE CALL TO BE HELD WEDNESDAY, FEBRUARY 28, 2024, AT 8:30 AM ET
NEW YORK, Feb. 23, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced that a conference call will be held on Wednesday, February 28, 2024, at 8:30 AM ET to discuss results for the fourth quarter and year-end 2023 and provide a business outlook for 2024. Michael S. Weiss, Chairman and Chief Executive Officer, will host the call.
In order 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 Fourth Quarter and Year End Update Call. A live webcast of this presentation will be available on the Events page, located within the Investors & Media section, of the Company's website at www.tgtherapeutics.com. An audio recording of the conference call will also be available for replay at www.tgtherapeutics.com, for a period of 30 days after the call.
TG Therapeutics will announce its financial results for this period in a press release to be issued prior to the call.
TG Therapeutics Announces Schedule of Data Presentations for BRIUMVI® (ublituximab) in Multiple Sclerosis at the Americas Committee for Treatment and Research in Multiple Sclerosis Annual Forum
https://ir.tgtherapeutics.com/news-releases/news-release-det…
https://ir.tgtherapeutics.com/news-releases/news-release-det…
Antwort auf Beitrag Nr.: 75.080.370 von questionmark am 10.01.24 16:50:02Übertrieben , wird sich wieder erholen
kommt nicht so gut an, mal sehen, wo das heute endet
https://ir.tgtherapeutics.com/news-releases/news-release-det…
TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones
Jan 10, 2024
Preliminary U.S. BRIUMVI fourth quarter and full year 2023 net product revenue of approximately $40 million and $89 million, respectively
Preliminary year-end 2023 cash position of approximately $215 million
NEW YORK, Jan. 10, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) yesterday announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2023 (unaudited), as well as financial guidance and development milestones for 2024, during a preannounced presentation at the 42nd Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide deck are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to share our preliminary fourth quarter and year end U.S. BRIUMVI net product revenue. As we head into 2024, we have our sights set on achieving revenue and expense targets and have built an ambitious plan to potentially expand the utility of BRIUMVI into new indications and for use as a subcutaneous injection. We are also excited to expand our R&D program with the recent licensing of azer-cel, an allogeneic CD19 CAR T therapy which we believe has the potential to become a meaningful therapy to treat various autoimmune disorders.”
Preliminary Fourth Quarter and Full Year 2023 Updates (based on unaudited financial information)
BRIUMVI U.S. net product revenue expected to be approximately $40 million and $89 million for the fourth quarter and full year of 2023, respectively
Year-end 2023 cash position of approximately $215 million
Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results planned to occur February 2024.
2024 Target Guidance
BRIUMVI U.S. net product revenue targets of approximately $41-$46 million and $220-$260 million for the first quarter and full year 2024, respectively
Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones
Commence clinical development of subcutaneous BRIUMVI
Commence a trial evaluating BRIUMVI in additional autoimmune diseases outside of Multiple Sclerosis (MS)
Commence a trial evaluating azer-cel in autoimmune disease
Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
TG Therapeutics Provides Preliminary Fourth Quarter and Full Year 2023 Net Revenue and 2024 Anticipated Milestones
Jan 10, 2024
Preliminary U.S. BRIUMVI fourth quarter and full year 2023 net product revenue of approximately $40 million and $89 million, respectively
Preliminary year-end 2023 cash position of approximately $215 million
NEW YORK, Jan. 10, 2024 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX) yesterday announced preliminary U.S. net product revenue for BRIUMVI® for the fourth quarter and full year ended December 31, 2023 (unaudited), as well as financial guidance and development milestones for 2024, during a preannounced presentation at the 42nd Annual J.P Morgan Healthcare Conference. An audio replay of the event, as well as the corresponding slide deck are available on the Investors and Media section of the TG corporate website at ir.tgtherapeutics.com/events.
Michael S. Weiss, Chairman and Chief Executive Officer of TG Therapeutics stated, “We are excited to share our preliminary fourth quarter and year end U.S. BRIUMVI net product revenue. As we head into 2024, we have our sights set on achieving revenue and expense targets and have built an ambitious plan to potentially expand the utility of BRIUMVI into new indications and for use as a subcutaneous injection. We are also excited to expand our R&D program with the recent licensing of azer-cel, an allogeneic CD19 CAR T therapy which we believe has the potential to become a meaningful therapy to treat various autoimmune disorders.”
Preliminary Fourth Quarter and Full Year 2023 Updates (based on unaudited financial information)
BRIUMVI U.S. net product revenue expected to be approximately $40 million and $89 million for the fourth quarter and full year of 2023, respectively
Year-end 2023 cash position of approximately $215 million
Preliminary selected financial information presented in this release are unaudited, subject to financial closing procedures and adjustment, and provided as an approximation in advance of the Company’s announcement of complete financial results planned to occur February 2024.
2024 Target Guidance
BRIUMVI U.S. net product revenue targets of approximately $41-$46 million and $220-$260 million for the first quarter and full year 2024, respectively
Full year 2024 target operating expense of approximately $250 million
2024 Development Pipeline Anticipated Milestones
Commence clinical development of subcutaneous BRIUMVI
Commence a trial evaluating BRIUMVI in additional autoimmune diseases outside of Multiple Sclerosis (MS)
Commence a trial evaluating azer-cel in autoimmune disease
Present data from the ENHANCE Phase 3b CD20 switch trial at multiple conferences throughout the year
Durchsuchen
