Insmed: PAH Treatment Advancement With 2nd Half 2025 Top-Line Data

seekingalpha11-21 03:09

Insmed Incorporated's ARIKAYCE, approved for MAC lung disease, achieved strong revenue growth in Q3 of 2024 and potential for expanded FDA approval, boosting its market opportunity.Brensocatib's NDA ...

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AscentXmedia/E+ via Getty Images  Insmed Incorporated (NASDAQ:INSM) is in a good position as a pharmaceutical company. It has already received regulatory approval in several territories for its drug known as ARIKAYCE which has been approved to treat patients with MAC [mycobacterium avium complex] lung disease or MAC lung disease. The premise here is that sales of this drug are at a healthy growth rate, even with it not targeting the entire patient population. ARIKAYCE revenues for Q3 of 2024 reached $93.4 million, reflecting a year-over-year growth of 18%. Speaking of this patient population, there is an opportunity for it to expand the label of this drug to include all MAC lung disease patients. This would be through the possibility of asking the FDA if it can expand the label of it using the prior ARISE study. This trial tested ARIKAYCE in newly diagnosed or recurrent MAC lung disease patients who had not yet started taking any antibiotics. Even if granted Accelerated Approval under this pathway for this patient population, it would still have to see success with the phase 3 ENCORE trial to convert to “Full Approval” of it. Another catalyst opportunity on the regulatory front would be in terms of the New Drug Application [NDA] filing of brensocatib for the treatment of patients with bronchiectasis, which is expected in Q4 of 2024. If filed at this time, then it could potentially put U.S. launch of it by mid-2025. A solid program that I want to go over though, where I believe a bigger market opportunity exists, would be regarding the development of treprostinil palmitil inhalation powder [TPIP] for the treatment of patients with Pulmonary Arterial Hypertension [PAH]. There is an ongoing phase 2b study using this drug to treat these patients, with top-line results to be released from it in the 2nd half of 2025. What is also expected to happen is the initiation of a phase 3 study targeting patients with Pulmonary Hypertension associated with interstitial lung disease [PH-ILD]. Treprostinil Palmitil Inhalation Powder For Patients With Pulmonary Arterial Hypertension The company continues to make multiple advancements on the regulatory front with the expanded label of ARIKAYCE and NDA filing of brensocatib for the treatment of patients with bronchiectasis. However, I think that even better shareholder value can be created if the next program I'm about to go over continues to achieve success in the clinic. This would be regarding the ongoing phase 2b study, using Treprostinil Palmitil Inhalation Powder [TPIP] for the treatment of patients with Pulmonary Arterial Hypertension. Before going over this mid-stage trial, plus any catalysts to come out of this program, it is first important to understand what this disorder is and what the possible market opportunity for it could be. Pulmonary Arterial Hypertension [PAH] is a type of disorder characterized as high blood pressure in the small arteries of the lungs. That is, blood flow to the lungs is not as efficient as it should be due to narrow or blocked small arteries. There are several symptoms that these patients with PAH experience, and they are as follows:  Shortness of breath  Heavily pounding heartbeat Fatigue  Swelling of feet or legs  Blue fingers.  The global Pulmonary Arterial Hypertension drug market is expected to grow to $11.6 billion by 2032. This is a massive market opportunity for this company to go after. Especially, as I noted above, there is a good opportunity to expand to patients with Pulmonary Hypertension associated with Interstitial Lung Disease [PH-ILD]. To see if TPIP is going to have an effect on being able to effectively treat these patients with PAH, it is in the process of running a phase 2b randomized, double-blind, placebo-controlled study. This trial is expected to recruit up to a total of 100 patients who will be randomized 2:1 to receive either of the following treatment regimens:  80 micrograms — 640 micrograms inhalation capsules of TPIP once-daily  Placebo inhalation capsules once-daily.  One key item to note is that directly above I show that patients are to receive between 80 micrograms to 640 micrograms. Why is this the case? That's because patients are going to first be started off only taking 80 micrograms of the drug and then up-titrated depending upon tolerability of it. The primary endpoint of this phase 2b study is looking at something known as change from baseline in Pulmonary Vascular Resistance or PVR at Week-16. A higher PVR in lung disease is known to be a cause for an increased mortality rate. Thus, the goal here is to see if TPIP can do better here regarding this efficacy measure compared to that of placebo. Another measure to prove whether this drug has an effect on being able to treat these PAH patients would be the efficacy measure of change from baseline in 6-minute walk test [6MWT] at specific daytime points. In this case, this particular endpoint is to be evaluated at Weeks 5, 10 and 16. A major catalyst for this program would be the release of top-line results from this ongoing phase 2b study, using TPIP to treat these patients with PAH, which are expected in the 2nd half of 2025. There is an ability for Insmed to expand the market opportunity for targeting patients with Pulmonary Hypertension. How so? Well, that's because it is already gearing up to initiate a phase 3 study in the 2nd half of 2025 using TPIP to treat patients with Pulmonary Hypertension associated with Interstitial Lung Disease [PH-ILD]. This type of hypertension is characterized as a lung disease where ILD causes PH. This disease is terrible regarding exercise and functional capacity being ideal and has an increased risk of hospitalization or death. The ability for it to move towards phase 3 testing, is because of its findings from a prior phase 2 study. First, TPIP was shown to have lower rates of treatment discontinuations and serious adverse events [SAEs] compared to that of placebo. Secondly, the company was able to observe a lower percentage of patients with clinical worsening events for those who took drug compared to placebo. This is noted as 3 out of 29 patients [10.3%] seeing clinical worsening events, compared to 5 out of 10 patients [50%] seeing this. Thus, the exploratory efficacy endpoints, along with the safety profile observed, are good reasons to move this towards phase 3 testing. Financials According to the 10-Q SEC Filing, Insmed had cash, cash equivalents and marketable securities of $1.5 billion as of September 30, 2024. The reason for the cash on hand is that it completed an underwritten public offering of 14,514,562 shares of common stock at a public offering price of $51.50 per share. The underwriters were given the option to exercise the full amount of 1,893,203 shares of common stock at the same purchase price. The total net proceeds from the sale of these shares ended up being $713.2 million after deducting expenses. This biotech is starting to generate some revenues with the sale of ARIKAYCE for the treatment of patients with MAC lung disease. Having said that, total revenue for Q3 of 2024 was $93.4 million, which was a year-over-year increase of 18%. The company burns roughly $290.9 million of cash per quarter. This is a large amount of cash, but it may need to continue to enact further dilution. The reason was stated in its 10-Q SEC filing, which is that it believes it has a cash runway of enough cash on hand to fund its operations for at least the next 12 months. Despite this, it notes that it still may raise funds opportunistically through debt financing or equity sales. Another option it is not taking off the table would be a strategic transaction of some sort. It is not clear when exactly another raise will happen, but the projection of cash runway means it is highly likely to raise funds at some point in 2025. Risks To Business There are several risks that investors should be aware of before investing in Insmed. The first risk to consider would be with the development of TPIP in the ongoing phase 2b study targeting patients with PAH. That's because top-line results from this specific study are expected to be released in the 2nd half of 2025. The risk here is that there is no assurance that the primary endpoint of change from baseline of Pulmonary Vascular Resistance [PVR] at week 16 will be met with statistical significance. Nor, that the company will be in a position to initiate a phase 3 study using TPIP to target this patient population in 2026 as expected. The second risk to consider would be in terms of the phase 3 trial using TPIP to treat patients with PH-ILD. This trial is expected to be initiated in the 2nd half of 2025 and there is no assurance that the primary endpoint of this trial will be met with statistical significance. Nor, that any regulatory agency is ultimately going to grant marketing approval of this drug to treat these patients with PH-ILD. The third risk to consider would be in terms of the development of brensocatib for the treatment of patients with bronchiectasis and other related treatment disorders. That's because the goal is to eventually expand the use of this drug to target Chronic Rhinosinusitis without Nasal Polyps [CRSsNP] and Hidradenitis Suppurativa [HS]. The risk here is that even if brensocatib works in treating patients with bronchiectasis, there is no assurance that it will work in a similar or superior fashion against these other two indications. Speaking of the CRSsNP indication, it is expected that top-line results from the phase 2 study for it will be released in the 2nd half of 2025. The fourth and final risk to consider would be in terms of the financial position that this company is in. That's because, as I noted above, it believes that it will only have enough cash on hand to fund its operations for at least the next 12 months. This means that it is likely going to need to raise additional funds in the coming months, likely at some point in 2025. The risk here is that the company could possibly raise cash either through selling shares of its common stock or taking on debt. Either way, any type of cash raising activity [outside a strategic transaction or partnership] will be a burden for shareholders. Conclusion Insmed has been able to do well regarding the first drug it has received regulatory approval for from its pipeline. This would be with the candidate from its pipeline being sold under the name ARIKAYCE, which was approved to treat patients with MAC Lung Disease. There is an opportunity to further expand the label of this drug to include this entire patient population through an Accelerated Approval pathway. This would be with the already completed phase 3 ARISE study, which might allow for such a pathway if the FDA agrees. Either this, or the company may have to rely on the other ongoing phase 3b ENCORE study, using ARIKAYCE to treat newly diagnosed or recurrent MAC Lung Disease patients who have not started antibiotics.  The company has two other entirely different programs with massive expansion potential. For instance, in terms of brensocatib, the goal is to go after patients with bronchiectasis, CRSsNP and Hidradenitis Suppurativa [HS]. On the other hand, there is potential with TPIP to go after patients with PAH and PH-ILD. With top-line results from the phase 2b study using TPIP for the treatment of patients with PAH 2nd half of 2025, plus the ability to expand the label of ARIKAYCE for MAC Lung Disease, I believe that investors could benefit from any potential gains made here.","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":"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":"4.29.2","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/2485121106"}