TG Therapeutics Inc (TGTX) Q3 2024 Earnings Call Highlights: Record Revenue Growth and ...

GuruFocus.com11-05

US Net Sales: $83.3 million for the third quarter. Quarter-over-Quarter Revenue Growth: Approximately 15% increase. Year-over-Year Revenue Growth: Over 230% growth from the same quarter last year. Net...

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GuruFocus has detected 5 Warning Signs with TGTX.\n\nRelease Date: November 04, 2024\nFor the complete transcript of the earnings call, please refer to the full earnings call transcript.\n Positive Points \n\nTG Therapeutics Inc (NASDAQ:TGTX) reported strong third-quarter US net sales of $83.3 million, reflecting approximately 15% quarter-over-quarter growth and over 230% growth from the same quarter last year.\nThe company has achieved significant market penetration with BRIUMVI, reaching nearly 1,100 prescribers across approximately 600 centers, including 95% of the top 100 MS centers.\nPositive long-term data from the ultimate one and two trials showed that 92% of patients were free from disability progression after five years of BRIUMVI treatment.\nTG Therapeutics Inc (NASDAQ:TGTX) is expanding its commercial infrastructure, having nearly doubled its commercial field team over the last two years to support rising demand.\nThe company is exploring new market opportunities with the development of a subcutaneous version of BRIUMVI, which could open up a new market segment for at-home self-administration.\n\n Negative Points \n\nThe company faces risks associated with forward-looking statements, which may cause actual results to differ materially from expectations.\nTG Therapeutics Inc (NASDAQ:TGTX) is moving away from providing specific enrollment numbers due to fluctuating capture rates, particularly as more hospitals, which are less likely to use the company's hub, become involved.\nThe timeline for incorporating faster infusion times and skipping loading doses into clinical practice could take 2 to 3 years, indicating a lengthy process for label updates.\nThe company has not yet provided specific shares for newly diagnosed or new to CD 20 patients, which may limit visibility into market penetration in these segments.\nThere is uncertainty regarding the pace of enrollment and data availability for the phase one study of Azure cell, an investigational CD 19 CAR T cell therapy, which may impact timelines for potential new treatments.\n\n Q & A Highlights \nQ: Can you provide insights on the size of the anti-CD 20 market in MS for 2025 and your market share expectations for BRIUMVI, including IV versus sub-Q? A: Adam Waldman, Chief Commercialization Officer, stated that the CD 20 market is currently in the low 50% range of dynamic share and is expected to grow to mid-50s or even 60%. BRIUMVI currently holds about 15% of the CD 20 market, with significant room for growth. The IV to sub-Q ratio is around 70% IV, which is expected to continue as the patient preference.\nQ: Will the agreement with Fuji Film for secondary US-based manufacturing impact gross margins? A: Sean Power, Chief Financial Officer, confirmed that there will be no impact on gross margins in the near term. There will be some upfront expenditures, but these will run through R&D, and long-term gross margins are expected to remain consistent.\nQ: What are the requirements for supporting a label indication for a faster infusion time or skipping a loading dose for switch patients? A: Michael Weiss, CEO, explained that randomized trials focusing on safety and tolerability are typically required for faster infusion approvals. It is unclear if more than one infusion per patient will be needed, but the primary focus will be on safety.\nQ: Can you discuss the expected growth dynamics for BRIUMVI in 2025? A: Adam Waldman indicated that the company expects continued sequential revenue growth. They are making investments in patient awareness and marketing, aiming to make BRIUMVI a Blockbuster brand. Seasonal dynamics in the MS market may affect quarterly growth, but the company is optimistic about future growth.\nQ: What are the capital allocation priorities, and are there plans to expand the share buyback program? A: Michael Weiss stated that the company is committed to continuing the share buyback program. They are also investing in expanding the commercial team, marketing efforts, and clinical programs for BRIUMVI. Additionally, they are exploring business development opportunities that complement their current operations.\nFor the complete transcript of the earnings call, please refer to the full earnings call transcript.This article first appeared on \nGuruFocus.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":1},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.2","shortVersion":"4.29.2","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2481254202"}