Keith O'Toole

$vera ***deep dive long*** as promised, deep dive before open tomorrow. I like this setup, with a PT of $90 , not many 100% + setups in this tape. So you’re welcome. Atacicept’s AA PDUFA coming up Monday or Tuesday this week. $vera is trading at $41 (~$3B cap, ~$2.4B EV), and btw Otsuka headline is what caused the sell off on Friday. I think people are trading the competitive optics and ignoring how big the TAM is getting. In fact the market is bigger than the Street models and KDIGO 2025 is why. The lazy version is treat obvious high risk ≥1 g/day proteinuria, everyone else stays on Gx + SGLT2. But get with the times bro. KDIGO 2025 moved the goalposts… biopsy is now recommended at possible IgAN with proteinuria >0.5 g/day or reduced eGFR and the treatment target dropped to <0.5 g/day, ideally <0.3. That pulls a materially larger pop into an active treat/escalate pathway and pushes disease modifying therapy toward any pt with disease because even a hemodynamically stable pt on ACE/ARB + SGLT2 with low proteinuria is still accruing slow tissue damage. Add an APRIL or APRIL/BAFF early enough and you can potentially arrest that before proteinuria even starts (and proteinuria itself damages the kidney over time). This is why I think the whole category has been under modeled, not just $vera ~100k US pts is the number people anchor to, but there are ~50k across just 10 European countries before you count the rest of Europe and China/Asia carries the highest IgAN burden on earth. Now the revenue math only ~2,500 treated patients gets you to ~$1B at current pricing. For context Otsuka added ~880 patients in Q1 alone. Run it forward… at ~$300k net off ~$390k gross (23% GTN … baking in real competitive friction), 15k active patients 1/10 of the US population alone is $4.5B in revenue. Sensitize net down to $250k (36% GTN) and 20k patients still does $5B. At a ~$2.4B EV, $vera only needs a fraction of IgAN to drive real upside. I think TAM $20–30B once you account for the KDIGO shift and ex US. A recent KOL survey points to heavy branded uptake… docs expect to put ~75% of their IgAN patients on new agents, including combos. ERAs and B cell agents are each projected to reach 35–40% of pts within 5 years two large categories stacking on top of each other consistent with a >$10B class. B cell uptake specifically is fast: ~17% penetration by 6 months, ~30% within a year. On the H2H stuff the survey says atacicept is not at a disadvantage. Nephrologists view the three lead B cell agents (atacicept, povetacicept, sibeprenlimab) as comparable on efficacy. Where they split them is marginal: povetacicept is seen as weaker on safety, atacicept slightly weaker on dosing i.e. the weekly cadence, which is precisely the gap that monthly dosing data would close. Survey implied intra class penetration lands around sibeprenlimab ~19%, atacicept ~12%, povetacicept ~12% , atacicept at parity with pove and within a few points of the first mover... The real gating factor is access and it’s class wide. The docs surveys dominant hurdle isn’t efficacy differentiation, it’s payer friction.. prior auths, SOC step throughs, sometimes proteinuria thresholds (typically 1–1.5 g). That’s a category dynamic every entrant shares not a $vera specific prob, and it argues the bear narrative is aimed at the wrong variable. Meanwhile about half of docs would consider combo use, most commonly B cell + ERA, which validates the stacking to UPCR<0.3 thesis and grows the treated base rather than forcing a 0 sum share fight.

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Keith O'Toole @KeithFnOToole

3 days ago

@DanHaymore @jimmy_dore

Keith O'Toole @KeithFnOToole

11 days ago

@wikileaks I wonder if Hillary wants to drone strike him too 🤔

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Keith O'Toole @KeithFnOToole

11 days ago

@Riggurmortis1 @jimmy_dore @MegynKellyShow @megynkelly "Why don't you move to (fill in the blank) then" is the mating call of the American idiot.

Keith O'Toole @KeithFnOToole

11 days ago

@jimmy_dore @MegynKellyShow @megynkelly Wow, people who eat a big bowl of CIA propaganda for breakfast every morning sure are angry about this post.

Keith O'Toole @KeithFnOToole

21 days ago

@unusual_whales Wait a few months until the everything bubble pops.

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Keith O'Toole @KeithFnOToole

21 days ago

@RossDellenger In a recent poll, an overwhelming majority of Americans who were sleeping underneath bridges that were dangerously close to collapsing on top of them were outraged by this decision. They felt the government should be doing more to regulate college sports.