TGTX JPM 2025 Presentation 1.13.25.pdf

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1、FIERCELY FOCUSEDJanuary 2025J.P.Morgan Healthcare Conference 2Forward Looking Safe Harbor StatementThis presentation 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 con

2、tained in the Private Securities Litigation Reform Act of 1995.Such forward looking statements include but are not limited to statements regarding expectations for success of our commercial launch and availability of BRIUMVI(ublituximab-xiiy)for relapsing forms of multiple sclerosis(RMS);anticipated

3、 healthcare professional and patient acceptance and use of BRIUMVI for the FDA-approved indications,statements regarding the results of the ULTIMATE I&II Phase 3 studies as well as the long term safety study and BRIUMVI as a potential treatment for RMS and our statements regarding our potential reve

4、nue targets,operating expenses and cash position.Additional factors that could cause our actual results to differ materially include the following:the Companys ability to establish and maintain a commercial infrastructure for BRIUMVI,and to successfully or in the timeframe projected,launch,market an

5、d sell BRIUMVI;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 Companys projections and estimates about the potential market for BRIUMVI due to a number o

6、f 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 Companys ability to

7、 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 Companys reliance on third parties for manufacturing,distribution and supply,and other support functions for our clin

8、ical 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 Companys plans to seek marketing approval for the product in jurisdictions out

9、side of the U.S.;the uncertainties inherent in research and development;and general political,economic and business conditions.The preliminary,estimated financial results for the fourth quarter and fiscal year ended 2024 and the 2025 guidance estimates provided in this presentation contain forward-l

10、ooking statements and are subject to the completion of managements and the audit committees final reviews and our other financial closing procedures and are therefore subject to change.Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for

11、 the fiscal year ended December 31,2023 and in our other filings with the U.S.Securities and Exchange Commission.Any forward-looking statements set forth in this presentation speak only as of the date of this presentation.We do not undertake to update any of these forward-looking statements to refle

12、ct events or circumstances that occur after the date hereof.About TG Therapeutics3325 Employees1 Approved Drug2Products Under DevelopmentFounded in 2012 with a focus on treatments for B-cell mediated diseasesCorporate HQ in Research Triangle,NCa next-generation,anti-CD20 monoclonal antibody42023Janu

13、ary 26TG launched BRIUMVI making it commercially available in the U.S.2024February 26BRIUMVI launched in Germany with ex-U.S.partner NeuraxPharm2022December 28BRIUMVI approved by the U.S.FDA to treat RMSBRIUMVI Indication:For the treatment of adults with relapsing forms of multiple sclerosis(RMS),in

14、cluding Relapsing Remitting,Clinically Isolated Syndrome and Active Secondary Progressive MS2042BRIUMVI U.S.composition of matter patent exclusivity expirationAnti-CD20 agents have transformed the treatment paradigm in Relapsing MS market 53Anti-CD20 monoclonal antibodies currently approved 48%of pa

15、tients in the US who are on a DMT are on an anti-CD201Anti-CD20All other DMTs1Komodo Claims.May-July 2024;2Based on earnings call reports from Roche,NVS and TGTX;3Based on Ocrevus,Kesimpta and Briumvi FactSet analyst sales consensus as of 12/20/2024 and historical US vs Ex-US revenue split$8BAnnuali

16、zed US anti-CD20 class sales2 BRIUMVI 3rd to market;no near-term additional anti-CD20 approvals expected in RMS Collectively,represent the most prescribed class of MS drugs As of end Q3 2024Growing to$12B by 203036The BRIUMVI DifferenceEfficacyBRIUMVI is the first and only anti-CD20 therapy to achie

17、ve less than 0.1 ARR in two phase 3 trialsaAdministrationOne hour infusion,twice per year,following the starting dose LabelBRIUMVI label does not include a risk of Breast Cancer DesignGlycoengineered to exclude certain sugar molecules that allows for tighter binding to NK cells with the goal of effi

18、cient B-cell depletionbPriceLowest price branded DMT available for MSa ARR for BRIUMVI observed in the ULTIMATE I and II phase 3 trials.Cross-trial comparisons are not appropriate given variation in patient populations enrolled across different trials.b The precise mechanism by which BRIUMVI exerts

19、its therapeutic effects is unknown.Glycoengineering cannot be linked to any efficacy outcomes7Demonstrated Efficacy in Phase 3 Trials 1 1Cree BAC,Fox E,Hartung H,et al.Five Years of Ublituximab in Relapsing Multiple Sclerosis:Results from the Open-Label Extension of ULTIMATE I and II Studies.Poster

20、presented at:2024 European Committee for Treatment and Research in Multiple Sclerosis;September 18-20,2024;Copenhagen,Denmark.a Based on pooled data from two studies;DBP=double blind period of the ULTIMATE trials;OLE=Open Label Extension of ULTIMATE trialsBRIUMVI has an Established Safety Profile 18

21、1BRIUMVI(ublituximab-xiiy)Prescribing information.TG Therapeutics,Inc.;2024.2.Steinman L,et al.N Engl J Med.2022;387(8):704-714.aIncludes the following:nasopharyngitis,upper respiratory tract infection,respiratory tract infection,respiratory tract infection viral,pharyngitis,rhinitis,sinusitis,acute

22、 sinusitis,tonsillitis,laryngitis,chronic sinusitis,viral pharyngitis,viral rhinitis,viral upper respiratory tract infection,chronic tonsillitis,pharyngitis streptococcal,sinusitis bacterial,and tonsillitis bacterial.bIncludes the following:bronchitis,pneumonia,tracheitis,tracheobronchitis,COVID-19

23、pneumonia,bronchitis bacterial,and pneumonia viral.cIncludes several related terms.Rates of discontinuation were similar between both arms,with 90%of participants completing the 2-year treatment across both ULTIMATE I and II Overall infection rates of BRIUMVI(56%)and teriflunomide(54%)were similar.I

24、n the BRIUMVI arm,infections were predominantly mild to moderate in severity and consisted of upper respiratory tract infections(45%)and urinary tract infections(10%)Serious infections were 3%and 5%for teriflunomide and BRIUMVI,respectively 3 total deaths occurred among participants on BRIUMVI-Pneum

25、onia,encephalitis(post measles),salpingitis(post ectopic pregnancy)Adverse ReactionsBRIUMVI(n=545)%Teriflunomide(n=548)%Infusion reactions4812Upper respiratory tract infectionsa4541Lower respiratory tract infectionsb97Herpes virus-associated infectionsc65Pain in extremity64Insomnia63Fatigue54Adverse

26、 reactions with an incidence of at least 5%and greater than that of teriflunomide from ULTIMATE I&II trials1Cree BAC,Fox E,Hartung H,et al.Five Years of Ublituximab in Relapsing Multiple Sclerosis:Results from the Open-Label Extension of ULTIMATE I and II Studies.Poster presented at 2024 European Co

27、mmittee for Treatment and Research in Multiple Sclerosis;September 18-20,2024;Copenhagen,Denmark.2TG Therapeutics.Data on file,a In an exposure-adjusted analysis of adverse events;DBP:Double blind period of the ULTIMATE trials;OLE:Open Label Extension;EAIR,exposure-adjusted incidence rate;IRR,infusi

28、on-related reaction;PY,patient-years;SAE,serious adverse event;TEAE,treatment-emergent adverse event95-Year Data Underscore Consistency in the BRIUMVI Safety Profile1,2Ublituximab group,ULTIMATE I/II Pooled DBP(n=545,PY=1145.57)EAIR 95%CI per 100 PYUblituximab group,Pooled DBP+OLE(n=974,PY=3603.90)E

29、AIR 95%CI per 100 PYAny treatment emergent adverse event(TEAE)374.84 363.79,386.22205.08 200.46,209.81TEAE leading to treatment discontinuation1.66 1.06,2.601.69 1.32,2.18Infection80.92 75.88,86.3048.61 46.39,50.94Infusion-related reaction54.12 50.02,58.5526.69 25.06,28.43Malignancy0.17 0.04,0.700.1

30、7 0.07,0.37Serious adverse event5.59 4.37,7.145.88 5.14,6.73Serious infection2.10 1.40,3.132.58 2.11,3.16Deaths0.26 0.08,0.810.17 0.07,0.37Overall safety profile of BRIUMVI remained consistent over 5 years of treatment,a with no new safety signals emerging with prolonged treatment as of the cutoff d

31、ate of January 1,2024 10US Commercial Launch StrategyStaged-approach to maximize ROI Year 1 Year 2Year 3Hyper-Focused Targeting HCPs in Top MS Centers Expanded Reach&Increased Investment in HCP Education and DifferentiationBroad Media to Increase Patient EngagementHow do you take on your RMS?Impleme

32、nting for 202511BRIUMVI U.S.Strong Uptake Continues1$399MCumulative Net SalesLTD$103.6MU.S.Net Sales Q4 2024$310MU.S.Net SalesFY 2024Jan 2024 FY consensus$250 million2BRIUMVI significantly exceeded expectations since launch1Q4 2024 and FY 2024 figures included are preliminary,unaudited,subject to ad

33、justment,and provided as an approximation in advance of the Companys announcement of complete financial results 2Consensus number for 2024 was obtained from FactSet on 1/5/2024 and include ex-US royalties and milestones;Q4:Fourth Quarter;FY:Full Year;LTD:Launch to date7.81625.139.950.572.683.3103.60

34、20406080100120Q12023Q22023Q32023Q42023Q12024Q22024Q32024Q42024U.S.BRIUMVI Quarterly Net Revenue($in Millions)160%growth vs Q4 202312Exceeding Revenue Expectations with Operational Efficiency198%189%171%98%82%65%49%31%0%50%100%150%200%250%TG TherapeuticsNeurocrineArgenxNeurology AnalogAverage*Biohave

35、nAcadiaAurinaIntra-CellularTherapiesProduct Net Sales/SG&A in 7th Quarter of LaunchTG vs Neurology Company Analogs1*Average of neurology analog Net Sales/SG&A ratio%s;Sources:Neurology analog company quarterly earnings Q324$83.3M Net Sales/$42.0M SG&A1Neurology analogs shown include companies with a

36、 single product for 7th quarter of launch analysis.Earliest approval was Nuplazid(Acadia)in Apr16 13Our Goal is to be the#1 prescribed CD20 in RMS based on Dynamic Market Share#114Significant Opportunity to Grow the BRIUMVI Franchise Across Both Distinct anti-CD20 MarketsCD20 U.S.Dynamic Market Shar

37、e1SubQ CD20IV CD2060%IV CD2040%Subcutaneous CD20Continue to drive market share gains for IV BRIUMVIDevelop potentially best-in-class patient administered SubQ BRIUMVI1Komodo Claims Q1-Q3 2024;SubQ:Subuctaneous BRIUMVIOCRELIZUMABOFATUMUMAB a+/-5 minutes,data obtained from ULTIMATE trialsContinue to D

38、rive Market Share Gains with IV BRIUMVIIVCD20 MarketExecute Stage 3 of Launch PlanEnhance the patient experience on IV BRIUMVI 12Current Regimen15Continue to Drive Market Share Gains with IV BRIUMVIIVCD20 MarketExecute Stage 3 of Launch PlanEnhance the patient experience on IV BRIUMVI 1216LAUNCH PIV

39、OTAL TRIALGOAL-Combining the current day 1 and day 15 IV doses of BRIUMVI into one 600mg day 1 dose LAUNCH PIVOTAL TRIALGOAL Reducing the infusion time for all maintenance IV BRIUMVI infusions to 30 min Develop Patient-Administered Subcutaneous BRIUMVI SubcutaneousPreliminary bioavailability studies

40、 providing support for at least every other month dosingTargeting pivotal trial to commence mid-year 2025Sub Q UpdateSub Q Target ProfileKey Attributes:Mode of Delivery:SubQ Auto-InjectorSite of Delivery:At homeHCP Required:NoFrequency:At least every other month1718Beyond BRIUMVI in RMSBRIUMVI Indic

41、ations Outside MSAzer-cel in MS&BeyondAllocate Capital to Generate ReturnsFirst indication for exploration Myasthenia gravis(MG)First MG patient enrolledOther indications under evaluation Allogeneic,“off-the-shelf”CD19 CAR-T partnered with Precision BioIND-clearedFirst indication Progressive MSExplo

42、re new pipeline opportunitiesContinue to repurchase sharesEvaluate other Invest opportunities19Key Development Goals and Objectives for 2025Commence pivotal program for SubQ BRIUMVICommence pivotal IV BRIUMVI trials to:1)combine the current Day 1&15 dose and 2)develop 30 minute maintenance infusions

43、Enroll BRIUMVI trial in Autoimmune disease(outside MS)Enroll into Azer-cel trial in Autoimmune disease(starting with Primary Progressive MS)20Financial Guidance1 for 20251All figures presented on this slide are estimates,unaudited,subject to adjustment,and provided as an approximation in advance of the Companys announcement of complete financial results FY:Full Year$525MFY 2025 BRIUMVI U.S.Net Revenue$300MFY 2025 Operating Expense Target(excluding non-cash compensation)$310MCash Estimate(beginning 2025)$540MFY 2025 Total Global RevenueNASDAQ:TGTX