BridgeBio: With HELIOS-B Overhang Removed, Focus To Turn To Approval And Launch Of Acoramidis

seekingalpha08-31

BridgeBio's stock is underperforming this year despite the progress the company made in recent quarters.HELIOS-B trial of Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, but...

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Overhang Removed, Focus To Turn To Approval And Launch Of Acoramidis\n</h2>\n\n<h4 class=\"meta\">\n\n\n2024-08-31 20:00 GMT+8&nbsp;&nbsp;&nbsp;<a href=https://seekingalpha.com/article/4718289-bridgebio-with-helios-b-overhang-removed-focus-to-turn-to-approval-and-launch-of-acoramidis><strong>seekingalpha</strong></a>\n\n\n</h4>\n\n</header>\n<article>\n<div>\n<p>BridgeBio's stock is underperforming this year despite the progress the company made in recent quarters.HELIOS-B trial of Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, but...</p>\n\n<a href=\"https://seekingalpha.com/article/4718289-bridgebio-with-helios-b-overhang-removed-focus-to-turn-to-approval-and-launch-of-acoramidis\">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":"BK4581","symbol_name":"高盛持仓","start_time":0,"source_url":"https://seekingalpha.com/article/4718289-bridgebio-with-helios-b-overhang-removed-focus-to-turn-to-approval-and-launch-of-acoramidis","article_id":"2463770112","we_media_id":null,"thumbnails":["https://static.seekingalpha.com/cdn/s3/uploads/getty_images/1830248795/image_1830248795.jpg"],"rights":null,"url":"https://stock-news.laohu8.com/highlight/detail?id=2463770112","pubTimestamp":1725105600,"sourceInfo":{"source_id":"seekingalpha","name":"Seeking Alpha"},"weMediaInfo":null,"summary":"BridgeBio's stock is underperforming this year despite the progress the company made in recent quarters.HELIOS-B trial of Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, 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Alnylam's Amvuttra (vutrisiran) was keeping investors away from BridgeBio, but the data presentation this week should lift this overhang on the stock.Investor focus should turn to the potential FDA approval and launch of acoramidis for the treatment of ATTR CM, followed by three late-stage clinical readouts in 2025.I believe BridgeBio will be able to compete with Pfizer, Alnylam and other potential competitors in the ATTR CM market.BridgeBio looks attractive at current levels based on the combined potential of acoramidis and the late-stage clinical pipeline.   marrio31/iStock via Getty Images Shares of BridgeBio (NASDAQ:BBIO) are trading surprisingly poorly this year, despite the company moving toward the launch of acoramidis (pending FDA approval in late November), strengthening its balance sheet, reporting updated positive phase 2 data of infigratinib, announcing the spinout of its oncology unit, and more recently, spinning out several of its early-stage rare disease drugs into a new company called GondolaBio. The HELIOS-B trial of Alnylam’s (ALNY) Amvuttra (vutrisiran) was keeping investors away from BridgeBio, initially due to fears of its success and then due to its success based on the topline press release in June, and it is also possible that the financing transactions earlier this year, and even more so the ex-U.S. partnership for acoramidis with Bayer (OTCPK:BAYRY), telegraphed to the Street that a buyout is highly unlikely in the near-term. I do not believe that HELIOS-B results put BridgeBio and its lead asset acoramidis in any worse position and my baseline assumption when I added the stock to our model portfolio in late 2023 was that the HELIOS-B trial will show positive data. I also believe that this overhang is lifted after this week's detailed data presentation as the fears of Amvuttra showing significant superiority (on a cross-trial comparison basis) to acoramidis are now put to rest. The other reason to be bullish on BridgeBio is the rest of its pipeline, led by late-stage candidates infigratinib for the treatment of achondroplasia, hypochondroplasia and potentially other short stature conditions, encaleret for the treatment of autosomal dominant hypocalcemia type 1, and BBP-418 for the treatment of Limb-Girdle Muscular Dystrophy Type 2I. Acoramidis is in a good position to take market share in the rapidly growing ATTR cardiomyopathy market The debate about which drug will be the most used in the ATTR cardiomyopathy (‘ATTR CM’) will not end anytime soon. The HELIOS-B data showed that Alnylam cannot really claim superiority over Pfizer’s (PFE) tafamidis (Vyndaqel/Vyndamax), or over BridgeBio’s acoramidis. As I said in my Alnylam article focused on HELIOS-B data, it does not look (to me) that there is a clear winner here. The patient populations and trial conducts are different, but the topline efficacy of tafamidis, Amvuttra, and acoramidis are similar. BridgeBio is pointing out its superior cross-trial comparisons with a 42% reduction in all-cause mortality and cardiovascular hospitalizations compared to 25% for tafamidis, both at month 30, and 28-33% for Amvuttra up to 36 months. BridgeBio investor presentation There is also the early separation from placebo (at month 3) on the endpoint of time to all-cause mortality or first cardiovascular-related hospitalization for acoramidis. This early separation compares favorably to Amvuttra’s separation at approximately month 7 or 8. I should also note here the difference of \"first cardiovascular-related hospitalization\" for acoramidis and \"recurrent cardiovascular events\" for Amvuttra, so this is not exactly an apples-to-apples comparison. BridgeBio investor presentationAlnylam presentation Alnylam also needed to extend the follow-on in the trial while it was already up and running. If it did not do that and if it did not measure outcomes at months 36 or 42, the difference to placebo would be much lower. We cannot see the exact data at month 30, but looking at all-cause mortality curves, it is clear that they are much narrower at month 30 versus later time points where they widened considerably in Amvuttra’s favor. Alnylam presentation And if we look at acoramidis’ all-cause mortality curves, we can see that they have considerably widened by month 30 (the chart below is just the inverse, showing the mortality rate versus survival probability in Amvuttra’s chart above). BridgeBio investor presentation On the subject of which TTR stabilizer is better - acoramidis of tafamidis, BridgeBio can point to better stabilization compared to tafamidis, evidenced by higher serum TTR levels of acoramidis monotherapy and acoramidis in combination with tafamidis versus tafamidis monotherapy. As a reminder, acoramidis and tafamidis are orally available TTR stabilizers (they stabilize the misfolded, disease-causing TTR protein), while Amvuttra and Ionis Pharmaceuticals’ (IONS) eplontersen (Wainua) are TTR silencers (they reduce the level of the misfolded TTR protein). BridgeBio investor presentation BridgeBio is further claiming that the level of TTR stabilization is highly correlated with improved outcomes. The company presented data this week showing that “for every 5mg/dL increase in serum TTR level at Day 28 after treatment initiation, the risk of death through month 30 was reduced by 30.9% (the logistic model) and 26.1% (by the Cox proportional hazards model), showing a statistically significant correlation between increasing serum TTR and decreasing risk of death.” The company’s data further demonstrated that for each 1mg/dL increase in serum TTR (also on day 28), there was a 5.5% risk reduction in cardiovascular death through month 30 and 4.7% lower risk of a first cardiovascular hospitalization, also through month 30. These data should resonate with prescribers when they consider which stabilizer to prescribe to ATTR CM patients, or to consider switching patients from tafamidis to acoramidis if their disease is progressing. But overall, while I am favoring acoramidis and I am positioned because of it, in BridgeBio, I see no clear winner in this race and I will borrow my own thoughts from my Alnylam article:  I expect tafamidis to remain the market leader in the next few years due to its considerable first mover advantage, and I expect a close battle between acoramidis and Amvuttra, and for them to eventually overtake tafamidis by the early 2030s. I expect Wainua to be a decent commercial success as well, but based on the similar mechanism to Amvuttra, Wainua being a late-comer (topline results from its outcomes trial are now likely in 2026), and the convenience advantage of Amvuttra (once every three months subcutaneous dosing versus once a month for Wainua), I expect Amvuttra to be the preferred drug in the TTR silencer class. I will not claim false precision with the exact market split, but in terms of peak sales for the class, I believe this will become a $15 billion+ global market by the early 2030s, and I believe Amvuttra and acoramidis are capable of generating $2-3 billion in annual net sales by the late 2020s and $3+ billion at peak in the 2030s.  HELIOS-B overhang lifted, time to focus on regulatory reviews of acoramidis, its commercial launch, and three late-stage readouts in 2025 With HELIOS-B topline results and data presentation in the rearview mirror, it is time to focus on BridgeBio’s own events and catalysts. The key event this year is the PDUFA date for acoramidis for the treatment of ATTR CM in late November. And this is also the key risk to the investment thesis in the next few quarters. The data acoramidis generated look strong, there are no safety concerns either, but the things we do not see represent a risk for BridgeBio – the FDA can be notoriously difficult to approve drugs and can issue a complete response letter based on non-clinical issues in the NDA submission such as manufacturing and related activities. That is why I always say that no drug approval is a certainty because we cannot know the full contents of the regulatory submission, or whether there are issues identified in the review. That is, of course, unless the company notifies us of ongoing review issues (some do and some do not). If all goes well, then the quarterly earnings reports become important catalysts for the stock as we should see how the uptake of acoramidis looks like. Assuming a timely approval in November, I believe the company can exceed the next year’s revenue consensus of $236 million. The reasons I am optimistic about the launch are acoramidis’ overall profile and the size of the ATTR CM market, and how fast tafamidis' uptake was after launch. Global net sales of tafamidis were $41 million in Q1 2019, a quarter before the launch for the treatment of ATTR CM in the United States, and it was growing very modestly (it was available in Europe since 2011 for the treatment of polyneuropathy). By Q1 2020, quarterly sales reached $231 million, and it added nearly $800 million in annualized net sales (if we look at the difference in the annualized net sales run rate), and $429 million by Q4 2020. Tafamidis generated $2.46 billion in net sales in the first half of 2024 and is on track to exceed $5 billion in net sales for the full-year.   Pfizer earnings reports Pfizer was doing a lot of the heavy lifting since 2019 to raise disease awareness and that tafamidis is available to treat it, and while I do not expect acoramidis to come anywhere close to matching tafamidis’ early launch numbers, I believe there is potentially significant upside to next year’s revenue estimates. The approval in Europe is expected in 2025, but unlike the U.S. launch, I expect modest sales contribution next year because partner Bayer will need to work to secure reimbursement on a country-by-country basis. Moving on from acoramidis, we should also see three potentially registrational readouts in 2025:  Phase 3 results of infigratinib in achondroplasia patients. I believe this candidate is substantially de-risked based on the strong phase 2 data and infigratinib being an orally administered candidate. Repeating the phase 2 data in the phase 3 trial would put infigratinib in a good position to compete with BioMarin’s (BMRN) Voxzogo which is administered once daily as a subcutaneous injection. Phase 3 results of encaleret in autosomal dominant hypocalcemia type 1 (‘ADH1’). I see encaleret as similarly clinically de-risked asset based on the positive phase 2b data showing significant treatment benefit. In the phase 2b trial, encaleret normalized mean blood calcium, PTH, and urine calcium in an 18-month period, and 69% of patients had normalized serum and urinary calcium at week 24 versus zero patients on the current standard of care at screening. Interim analysis from the phase 3 trial of BBP-418 for the treatment of Limb-Girdle Muscular Dystrophy Type 2I. Unlike the other two candidates, I see much higher risk of failure here, as these muscular dystrophies are extremely hard to treat and I have not seen the clinical data from BridgeBio to give me confidence in its success. As such, I will take any upside I can get from this candidate and believe the market is not assigning value to this candidate (and I am not either).  I should add that there is a one early-stage event before all these events – the updated phase 1 data of the gene therapy candidate BBP-631 for the treatment of congenital adrenal hyperplasia ('CAH'). The initial results were not as strong as the company hoped and it added an even higher dose cohort than the first three to see if it can deliver better efficacy. I believe this candidate is more likely to be discontinued as it is unlikely to reach the company’s goal of endogenous cortisol production. BridgeBio presentation Risks As mentioned in the previous section, the main risk to the thesis in the near-term is acoramidis receiving a complete response letter (‘CRL’) from the FDA for the treatment of ATTR CM in late November. I believe approval is likely based on the strong clinical efficacy and safety, but one can never be 100% sure about regulatory decisions. The CRL would put pressure on the balance sheet as a relatively large part of this year’s financing deal is contingent on acoramidis’ FDA approval, and we are likely looking at additional dilution at unfavorable terms if this happens. BridgeBio had $587 million in cash, equivalents, and marketable securities at the end of June and it will receive $500 million in cash from Blue Owl Capital and CPPIB Credit in exchange for a 5% royalty on acoramidis when it receives FDA approval. An additional tranche of up to $300 million from Blue Owl Capital is also available for \"strategic corporate development activities.\" If acoramidis is approved, launch execution becomes the next near-term risk, and would cause similar issues – sales underperformance and higher-than-expected cash burn would require additional cash infusions and potentially dilution. I do not expect the launch to underperform but it is possible for BridgeBio to go through some early, growing pains before it secures proper insurance coverage and it also takes time for sales reps to become productive. The other important risks are:  Clinical risks – we could see one or more of the mid- and late-stage candidates fail in trials or deliver underwhelming or uncompetitive data. Competition. We could see a greater-than-expected negative impact of the potential launches of Amvuttra in ATTR CM, and also of Ionis’ and AstraZeneca’s Wainua (pending positive phase 3 data in 2026 and launch in 2027). We could also see better competitors emerge in other areas of interest. For example, I see the potential risk to infigratinib from Ascendis Pharma’s (ASND) combination trial of TransCon CNP (once-weekly CNP analog) and Skytrofa (weekly growth hormone) that could show better annualized growth velocity than infigratinib. Ascendis expects to report the topline results from this phase 2 trial in the fourth quarter.  Conclusion With the HELIOS-B overhang in the rearview mirror, I expect investors to start focusing on BridgeBio itself and its late-stage clinical assets, led by acoramidis in ATTR CM. I see the stock as being worth between $52 and $69 per share, with more than half assigned to acoramidis based on it being able to generate $2.5 billion to $3 billion in annual sales by 2030, infigratinib generating $1 billion to $1.2 billion in annual sales, also by 2030, and encaleret has the lowest contribution, based on its ability to generate $500 million to $700 million in annual sales by 2030. I do not give credit to BBP-418, BBP-631, or the recent oncology and rare disease spinouts.   Author's estimates The low end of the valuation range is slightly above the average analyst price target of $49 per share, and the high end of the range is just below the highest analyst price target of $70 per share. I also see room for upside revisions based on the potential commercial outperformance of acoramidis, label expansion opportunities for infigratinib (hypochondroplasia and other short stature indications), positive phase 3 data of BBP-418, and pipeline expansion based on internal efforts and business development.  The key near-term valuation inflection points (and risks) are the FDA’s decision on whether to approve acoramidis for the treatment of ATTR CM on/by November 29, and the commercial launch. From there, investors can focus on quarterly sales updates (if acoramidis is approved), potential approval launch of acoramidis in Europe in 2025, and the three late-stage readouts of infigratinib, encaleret, and BBP-418.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"Product Release","news_rank":0,"symbols":[],"gpt_button":0},"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/2463770112"}