Verona Pharma's Ohtuvayre Set To Unlock Significant Value In COPD Care

seekingalpha09-14

Verona Pharma's Ohtuvayre (ensifentrine) was approved for COPD in June 2024, introducing a novel dual mechanism of action.Ohtuvayre is priced at $2,950 per month, significantly above ICER’s cost-...

Source Link

Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.

Comments

We need your insight to fill this gap

Leave a comment

{"i18n":{"language":"en_US"},"isChannel":false,"data":{"share":"https://ttm.financial/m/news/2467006220?lang=en_US&edition=fundamental","thumbnail":"https://static.seekingalpha.com/cdn/s3/uploads/getty_images/1727831783/image_1727831783.jpg","is_english":true,"pubTime":"2024-09-14 16:20","share_image_url":"https://static.laohu8.com/5a36db9d73b4222bc376d24ccc48c8a4","id":"2467006220","market":"us","top_or_hot":-1,"title":"Verona Pharma's Ohtuvayre Set To Unlock Significant Value In COPD Care","media":"seekingalpha","content":"<div>\n<p>Verona Pharma's Ohtuvayre (ensifentrine) was approved for COPD in June 2024, introducing a novel dual mechanism of action.Ohtuvayre is priced at $2,950 per month, significantly above ICER’s cost-...</p>\n\n<a href=\"https://seekingalpha.com/article/4721090-verona-pharmas-ohtuvayre-set-to-unlock-value-in-copd-care-vrna-stock\">Source Link</a>\n\n</div>\n","source":"seekingalpha","html":"<!DOCTYPE html>\n<html>\n<head>\n<meta http-equiv=\"Content-Type\" content=\"text/html; charset=utf-8\" />\n<meta name=\"viewport\" content=\"width=device-width,initial-scale=1.0,minimum-scale=1.0,maximum-scale=1.0,user-scalable=no\"/>\n<meta name=\"format-detection\" content=\"telephone=no,email=no,address=no\" />\n<title>Verona Pharma's Ohtuvayre Set To Unlock Significant Value In COPD Care</title>\n<style type=\"text/css\">\na,abbr,acronym,address,applet,article,aside,audio,b,big,blockquote,body,canvas,caption,center,cite,code,dd,del,details,dfn,div,dl,dt,\nem,embed,fieldset,figcaption,figure,footer,form,h1,h2,h3,h4,h5,h6,header,hgroup,html,i,iframe,img,ins,kbd,label,legend,li,mark,menu,nav,\nobject,ol,output,p,pre,q,ruby,s,samp,section,small,span,strike,strong,sub,summary,sup,table,tbody,td,tfoot,th,thead,time,tr,tt,u,ul,var,video{ font:inherit;margin:0;padding:0;vertical-align:baseline;border:0 }\nbody{ font-size:16px; line-height:1.5; color:#999; background:transparent; }\n.wrapper{ overflow:hidden;word-break:break-all;padding:10px; }\nh1,h2{ font-weight:normal; line-height:1.35; margin-bottom:.6em; }\nh3,h4,h5,h6{ line-height:1.35; margin-bottom:1em; }\nh1{ font-size:24px; }\nh2{ font-size:20px; }\nh3{ font-size:18px; }\nh4{ font-size:16px; }\nh5{ font-size:14px; }\nh6{ font-size:12px; }\np,ul,ol,blockquote,dl,table{ margin:1.2em 0; }\nul,ol{ margin-left:2em; }\nul{ list-style:disc; }\nol{ list-style:decimal; }\nli,li p{ margin:10px 0;}\nimg{ max-width:100%;display:block;margin:0 auto 1em; }\nblockquote{ color:#B5B2B1; border-left:3px solid #aaa; padding:1em; }\nstrong,b{font-weight:bold;}\nem,i{font-style:italic;}\ntable{ width:100%;border-collapse:collapse;border-spacing:1px;margin:1em 0;font-size:.9em; }\nth,td{ padding:5px;text-align:left;border:1px solid #aaa; }\nth{ font-weight:bold;background:#5d5d5d; }\n.symbol-link{font-weight:bold;}\n/* header{ border-bottom:1px solid #494756; } */\n.title{ margin:0 0 8px;line-height:1.3;color:#ddd; }\n.meta {color:#5e5c6d;font-size:13px;margin:0 0 .5em; }\na{text-decoration:none; color:#2a4b87;}\n.meta .head { display: inline-block; overflow: hidden}\n.head .h-thumb { width: 30px; height: 30px; margin: 0; padding: 0; border-radius: 50%; float: left;}\n.head .h-content { margin: 0; padding: 0 0 0 9px; float: left;}\n.head .h-name {font-size: 13px; color: #eee; margin: 0;}\n.head .h-time {font-size: 11px; color: #7E829C; margin: 0;line-height: 11px;}\n.small {font-size: 12.5px; display: inline-block; transform: scale(0.9); -webkit-transform: scale(0.9); transform-origin: left; -webkit-transform-origin: left;}\n.smaller {font-size: 12.5px; display: inline-block; transform: scale(0.8); -webkit-transform: scale(0.8); transform-origin: left; -webkit-transform-origin: left;}\n.bt-text {font-size: 12px;margin: 1.5em 0 0 0}\n.bt-text p {margin: 0}\n</style>\n</head>\n<body>\n<div class=\"wrapper\">\n<header>\n<h2 class=\"title\">\nVerona Pharma's Ohtuvayre Set To Unlock Significant Value In COPD Care\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-09-14 16:20 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4721090-verona-pharmas-ohtuvayre-set-to-unlock-value-in-copd-care-vrna-stock><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>Verona Pharma's Ohtuvayre (ensifentrine) was approved for COPD in June 2024, introducing a novel dual mechanism of action.Ohtuvayre is priced at $2,950 per month, significantly above ICER’s cost-...</p>\n\n<a href=\"https://seekingalpha.com/article/4721090-verona-pharmas-ohtuvayre-set-to-unlock-value-in-copd-care-vrna-stock\">Source Link</a>\n\n</div>\n\n\n</article>\n</div>\n</body>\n</html>\n","isBrief":false,"type":0,"news_type":1,"symbol":"BK4007","symbol_name":"制药","start_time":0,"source_url":"https://seekingalpha.com/article/4721090-verona-pharmas-ohtuvayre-set-to-unlock-value-in-copd-care-vrna-stock","article_id":"2467006220","we_media_id":null,"thumbnails":["https://static.seekingalpha.com/cdn/s3/uploads/getty_images/1727831783/image_1727831783.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2467006220","pubTimestamp":1726302000,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"Verona Pharma's Ohtuvayre (ensifentrine) was approved for COPD in June 2024, introducing a novel dual mechanism of action.Ohtuvayre is priced at $2,950 per month, significantly above ICER’s cost-effec","collect":0,"end_time":0,"defaultTopTitle":"seekingalpha.com","property":[],"viewcount":null,"language":"en","relate_stocks":{"BK4007":"制药","LU0566484027.USD":"安本美国小盘成长股","LGND":"Ligand Pharmaceuticals Inc.","LU1559883803.SGD":"Aberdeen Standard SICAV I - North American Smaller Companies Fund A Acc SGD-H","VRNA":"维罗纳制药","BK4139":"生物科技"},"translate_title":"Verona Pharma的Ohtuvayre将释放COPD护理的巨大价值","themeId":null,"isJumpTheme":false,"ttsUrl":null,"symbols_score_info":{"LGND":1,"VRNA":1},"content_text":"Verona Pharma's Ohtuvayre (ensifentrine) was approved for COPD in June 2024, introducing a novel dual mechanism of action.Ohtuvayre is priced at $2,950 per month, significantly above ICER’s cost-effectiveness benchmark of $7,500–$12,700 annually.The drug targets patients who experience exacerbations despite traditional triple therapy (LABA, LAMA, ICS), addressing an unmet need in COPD treatment.Verona's financial position is stable, with over $400 million in cash, but R&D and operating expenses are expected to rise.I recommend maintaining a \"buy\" rating, as Ohtuvayre offers strong potential despite market challenges and competition.   Sneksy/E+ via Getty Images Introduction I last wrote on Verona Pharma plc (NASDAQ:VRNA) a year ago. My recommendation was \"buy,\" noting the potential of their novel COPD treatment. Since then, its selective dual phosphodiesterase-3 (PDE3) and phosphodiesterase-4 (PDE4) inhibitor, Ohtuvayre (ensifentrine), was approved for the treatment of COPD. Subsequently, its stock has appreciated over 50% during this time. So I figure it's a good time to take another look at Verona as they begin launching Ohtuvayre. Verona Pharma’s Ohtuvayre Shows Potential Despite High Price, Market Risks Ohtuvayre was approved in June 2024 following the Phase 3 ENHANCE trials. Notably, it is the first inhaled product with a new mechanism of action for COPD in over two decades. Here is its label. It appears broad, clean (without major or atypical safety warnings), and is as expected. Verona priced Ohtuvayre aggressively, charging $2,950 for a monthly dose of the maintenance treatment. This implies an annual price of $35,400, which is significantly higher than ICER's benchmark of no more than $12,700 per year. Ohtuvayre figures to see utilization in patients who are still experiencing dyspnea (shortness of breath) despite the use of a LAMA (long-acting muscarinic antagonist) or a LABA (long-acting β2-agonist). However, the typical approach would be to have patients on both LABA and LAMA. So Ohtuvayre is a viable alternative for those who are unable to tolerate one of the other agents. It has been estimated that 40% of the 11.7 million COPD patients in the US continue to experience exacerbations despite maintenance therapies. This leaves about 4.6 million US patients searching for another option. Most of these patients will be started on an inhaled corticosteroid (ICS). However, approximately 25% of COPD patients are not ideal candidates for ICS. This figure may actually be higher. Long-term ICS use increases the risk of pneumonia. Moreover, ICS is most effective in patients with elevated blood eosinophil counts. Patients without this marker are less likely to benefit from ICS therapy. ICS is also associated with side effects like osteoporosis and high blood sugar. Ohtuvayre is recommended for patients who are \"resistant\" to triple therapy (LABA-LANA-ICS). Together, these are still sizable populations. For my discounted cash flow analysis, I estimated a US population of 1.15 million who would be suitable candidates for Ohtuvayre. As Verona notes in their investor slides, an expected duration of therapy is six months. So I adjusted the therapy costs accordingly. Due to theoretical barriers of cost, accessibility, and insurance coverage, I estimated a market share/penetration rate of just 10%.   Author The final calculation assumes linear growth in market share until the peak sales year, consistent drug pricing, specified probabilities of success, fixed COGS and operating expense percentages, and a defined discount rate to calculate the present value of future cash flows. The final risk-adjusted net present value ($3.974 billion) is the sum of all discounted profits from the market entry year until 2035.   Author  Author I limited the analysis to 2035 because Ohtuvayre's market exclusivity could be jeopardized sooner than usual. For example, its composition of matter patents expired in 2020. At the very least, the new chemical entity exclusivity should limit generic competition until 2029 (five years after approval). Of course, Verona owns a number of other patents that could extend Ohtuvayre's exclusivity until the mid-to-late 2030s. Also bear in mind that Verona's partner, Ligand (LGND), is \"entitled to a low single-digit royalty on worldwide net sales of Ohtuvayre.\" Financial Health As of June 30, Verona held $404.599 million in cash and cash equivalents. Total current assets were $416.292 million, while total current liabilities were just $48.346 million. This implies that Verona can readily cover any short-term obligations. Verona does owe $119.687 million in a \"term loan,\" as well as $96.338 million in a \"revenue interest purchase security agreement.\" As Verona launches Ohtuvayre for a chronic condition, its operating expenses have risen considerably. For Q2, R&D and SG&A expenses were $19.388 million and $49.035 million, respectively. The net loss in Q2 was $70.835 million, compared to just $8.807 million in the same period for the previous year. Verona believes their cash runway extends \"beyond 2026.\" VRNA Stock: Risk/Reward Analysis and Investment Recommendation Verona's Ohtuvayre is sure to make a difference in COPD treatment. According to Google, previous peak annual sales estimates for Ohtuvayre have typically ranged between $500 million and $1.1 billion. Given the number of COPD patients who continue to have exacerbations despite receiving triple therapy and Ohtuvayre's novel approach, I believe these are very conservative estimates. Verona will face significant challenges in marketing a new COPD drug, which I believe explains the high short interest. However, this is the type of advancement that pulmonologists should become familiar with on their own. So I believe this is more of a challenge in making Ohtuvayre available and accessible.   Author Despite its stock rallying 78% in the last six months, I believe Verona remains undervalued (maintain \"buy\"). The market is playing \"show me\" with Verona, and I cannot blame them. However, this gives investors plenty of time to climb aboard. I expect Ohtuvayre's market performance to pleasantly surprise due to the high need and novel approach.  Still, significant risks remain for Verona. Recent financing deals have strengthened their cash position, but $400 million is not a great amount, especially as the company is steadfast in its R&D pursuits (e.g., non-cystic fibrosis, asthma, ensifentrine + LAMA for maintenance COPD). The COPD market is highly competitive, and Ohtuvayre will compete with other drugs that I have not mentioned in this article. Furthermore, there may be clinical/treatment recommendation developments that do not favor Ohtuvayre. Although Ohtuvayre has a broad label, payers could restrict its access, especially because of its relatively high costs. As always, investors should maintain a diversified portfolio to mitigate idiosyncratic risks.","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":"analysis","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":"4.28.1","shortVersion":"4.28.1","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/2467006220"}