To The Moon

Females are naturally concerned about their weight and skin complexion, while males tend to focus on intimacy performance and hair loss.

This article is written by Shernice, if you like my article please hit the like button or do a repost. 

If you look around, you'll notice that more and more males are experiencing balding, and the age at which this happens seems to be getting younger. Men are also placing more emphasis on their appearance than in the past.

$Hims & Hers Health Inc.(HIMS)$  addresses these concerns, positioning itself to profit from both men and women.

As mention earlier in my previous posts of a potential short squeeze sent HIMS stock soaring from around $45 to $73, sparked by a Super Bowl commercial and 31% short interest. On Friday, it crashed 26% when the FDA announced semaglutide was officially off the shortage list.

The active ingredient in the hugely popular weight-loss drug Ozempic, is no longer on the FDA shortage list. During the shortage, companies like HIMS were allowed to compound and sell modified versions of semaglutide to meet high demand. However, with the shortage officially over, the FDA typically prohibits third-party compounding, leading the market to fear that HIMS will lose a significant revenue stream.

HIMS’ semaglutide offering, launched in May 2024, has been a major success, contributing an estimated 17% of the company’s revenue last quarter and driving substantial growth. The market’s sharp sell-off reflects concerns that losing this product could hurt HIMS’ revenue and profit growth. However, there are a few counterpoints to consider. First, the end of the shortage was inevitable, so this shouldn’t have been a complete surprise. Second, HIMS was thriving before semaglutide and could continue to do well without it long-term. Third, there’s a potential loophole: the FDA is allowing a 60- to 90-day grace period for compounders to keep selling, and HIMS might argue that its version of semaglutide isn’t “essentially a copy” of the FDA-approved drug if it offers significant patient benefits, potentially allowing continued sales under specific conditions.

The FDA’s own guidelines suggest that compounded drugs can still be sold if they provide a notable improvement over the commercial product, as determined by a prescribing practitioner. This ambiguity leaves room for HIMS to adapt. For now, the company has at least a couple of months to keep selling while sorting out its next steps. As for your position, it seems you’re weighing whether this dip is an overreaction—given HIMS’ solid fundamentals and this potential workaround—against the risk of longer-term revenue challenges.

Whether a compounded drug like HIMS’ version of semaglutide is considered “essentially a copy” of an FDA-approved product hinges on a key factor: patient outcomes. According to FDA guidelines, a compounded drug isn’t deemed a copy if it provides a significant difference—determined by a prescribing practitioner—that improves results for an individual patient compared to the commercially available version. If HIMS can demonstrate that its compounded semaglutide meaningfully enhances patient outcomes, it could have a solid case to keep compounding and selling it, even now that semaglutide is off the FDA shortage list.

So, does HIMS’ version deliver that significant improvement? Based on the Q3 2024 earnings transcript from the CEO, there’s a compelling argument that it does. The CEO highlighted that 70% of patients on the HIMS platform stick with their personalized GLP-1 treatment (like compounded semaglutide), compared to just 40% in traditional brick-and-mortar settings—a 30-point gap in adherence. Even more striking, public data shows typical GLP-1 retention rates (e.g., for drugs like Ozempic) drop to a dismal 10-15% after a year. HIMS’ 70% retention rate stands out as a massive leap.

The CEO attributes this to HIMS’ approach: compounding semaglutide in a way that reduces side effects, which nearly all GLP-1 users experience—think nausea, vomiting, muscle loss, and gastrointestinal issues. These side effects drive most patients to quit. HIMS tackles this through frequent provider communication (monthly check-ins to adjust dosing and regimens) and technology like Medmatch, which optimizes prescriptions from the start. By tailoring the treatment to minimize side effects, HIMS claims patients are far more likely to stick with it, boosting retention and, presumably, overall health outcomes.

If these claims hold up—say, through clinical data or practitioner testimony showing reduced side effects and better adherence translate to meaningfully better results—HIMS could argue its compounded version isn’t just a copy of Ozempic or other semaglutide drugs. That 70% retention versus 10-15% in the broader market is a strong datapoint. The FDA’s focus on “significant difference” for the patient could give HIMS room to keep this offering alive, shortage list or not. What do you think—does this retention gap feel like enough to sway the FDA, or would they need harder clinical proof?

The data indeed backs up the idea that HIMS’ compounded semaglutide is significantly boosting patient outcomes, with retention rates hitting 70% compared to the paltry 10-15% for standard GLP-1 drugs like Ozempic. That gap suggests their personalized approach—tweaking doses and regimens to cut down on side effects like nausea, vomiting, and muscle loss—is keeping patients on board far longer. If the FDA sees this as a meaningful improvement, HIMS might have a solid shot at continuing to compound semaglutide, even off the shortage list.

The CEO’s take on the GLP-1 business a year out adds another layer. He’s not sweating the shortage shift too much, pointing to a trio of strengths. First, their oral weight-loss offering, which skyrocketed to a $100 million run rate, delivers 70% of GLP-1 weight-loss results for just $70 a month—a budget-friendly alternative. Second, they’re rolling out generics like liraglutide in 2025, broadening their options. Third, for semaglutide itself, he doubles down on “hyper-personalization” as a game-changer, arguing it meets a critical need for the millions who can’t tolerate standard GLP-1 side effects. With over 100 million obese Americans and high dropout rates due to those side effects, he sees a lasting demand for HIMS’ tailored solutions.

His vibe is clear: HIMS isn’t just banking on compounded semaglutide. They’re building a flexible, durable weight-loss business—cheap orals, incoming generics, and personalized compounds—that can weather the FDA’s moves. The shortage ending might be a hiccup, but he’s betting on a big, underserved market keeping them in the game. Does this mix of data and strategy make you more bullish on HIMS, or are you still hung up on whether the FDA will greenlight their compounding pitch?

The CEO of HIMS is making a few key points that paint a picture of a business that’s not overly dependent on compounded semaglutide, even with Friday’s FDA news. First, he’s highlighting their non-GLP-1 weight-loss options—like their oral pill, which delivers 70% of GLP-1 effectiveness for just $70 a month. That offering hit a $100 million annual run rate faster than anything else on their platform, showing it’s a hit with customers and a big growth driver. Second, he’s eyeing a massive market—over 100 million obese Americans—and estimates at least 2 million need the kind of personalized treatment HIMS can provide through compounding. He believes this need, paired with FDA rules allowing compounding for significant patient improvements, means they can keep offering semaglutide to a targeted group, even off the shortage list.

His Xtweet on Friday doubles down on this: HIMS will continue compounding semaglutide for personalized treatments “as allowed by law,” citing ongoing demand and potential future shortages flagged by Novo Nordisk (the maker of Ozempic), which still faces supply constraints despite the FDA’s call. He’s also throwing shade at Novo’s $1,200+ U.S. price tag versus $135-$300 in Denmark, positioning HIMS as a more accessible option. So, he’s arguing they’ve got legal wiggle room and a market need to keep this going.

Then there’s the non-GLP-1 side of the business, which is the real sleeper hit here. Before launching GLP-1s in May 2024, HIMS was already growing like crazy. In Q3 2024, they added a record 180,000 subscribers, with most of that growth—40% year-over-year—coming from non-GLP-1 offerings. Total subscriber growth was 44%, so GLP-1s are a boost, not the backbone. Revenue tells a similar story: excluding GLP-1s, they hit over $300 million in Q3, up 46% year-over-year. With GLP-1s, growth jumped to 70%, but even without them, 50% growth is nothing to sneeze at. Looking back to 2021 through Q2 2024 (pre-GLP-1), revenue was already on a steep climb—GLP-1s just poured gas on the fire in Q3.

Your take seems spot-on: HIMS doesn’t live or die by GLP-1s. The 26% stock drop stings, but it’s on the heels of a 71% run-up over the past month—some cooling off isn’t shocking. The CEO’s confidence, the FDA’s personalization loophole, and the robust non-GLP-1 growth suggest this isn’t a death knell. They might scale back compounded semaglutide to a niche group, but the broader business looks sturdy. I'm seeing this as a buying opportunity.

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