Den kom akkurat på discorden, har ikke lest den enda:
Fjernet analysen, de blir så hissige på discorden om man deler derfra.
Dere kan heller joine discorden her: https://discord.gg/HAjjEpvq
Hva var det som var “partly worrying”? 
Om full label blir restricted til >1.5ug må nødvendigvis TAM justeres og deretter rNPV. Initiell tanke fra min side er at markedet priser inn dette og da skal den nok ytterligere ned om jeg ikke husker feil.
Var analysen permabear?
Akkurat og det får vi ikke svar på før en eventuell approval foreligger?
Nei. Den er så positiv som bare Uhde klarer om CALTX.
Skjønner meg ikke på denne aksjen…
Biotek er så fucked om dagen, blir å holde meg til denne rare lille saken kalt CombiGene♥️
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Min holdning er at CALTX stadig prises som et udviklings selskab.
Selv om full label kun bliver restrictet til >1,5ug så er det pasienter nok til at det bliver en Blockbusters. Og det er foreløbig på denne baggrund FDA har giver conditinal aproval.
Så må vi jo se om de endelige data bliver så dårlige at pasienter med <1,5ug bliver udelukket, eller får black box.
Hvor om alt er så er det en patientgruppe som ikke har andet alternativ. FDA har gitt conditional aprovel på disse data, det samme har EMA og det forventes vel at Kina vil gøre det samme.
Det kan sagtens være at kursen skal længere ned, men det hænger ikke nødvendig vis sammen med det fundamentale.
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Det gir jo ingen mening at Calle skal prises som et utviklingsselskap.
Like lite mening gir det at aksjen skal være frakoblet det fundamentale.
Combigene blir det siste halmstrået mitt! 
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Det er 1 analytiker som snakker om Black Box (SEB)
Data publisert i tidsskrift i dag var kjent for FDA da de fikk AA.
Tarpeyo er alene på markedet i behandling av IgA nefropati, eneste konkurrent har fått utsatt PDUFA.
IgA er en progressiv sykdom. Alle vil derfor etterhvert få UPCR > 1,5.
Det er vel ingen analytiker som har priset inn label expansion i sin analyse, så at aksjen skal rase 17% i dag er uforståelig.
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I verste fall er det altså “bare” dagens label som omfatter ca 70 % av markedet som videreføres. (dvs den pasientgruppen de selger til pr i dag) Det vil fortsatt gi et pent regnestykke.
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Nettopp. Og i denne pasientgruppen er dataene råsterke. Så får en eventuell label extension bli en bonus.
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Det findes ikke et efficient marked, og især biotec selskaber er helt frakoblet det fundamentale både i possitv og negativ retning.
Indtil de begynder og selge produkter, og det er Calle igang med. Derfor forstår jeg din frustration, for nu begynder man at kunne regne på indtjening, og så skal Calle prissættes helt anderledes.
Er i øvrigt helt enig med @Tdog og @sjog i deres vurderinger.
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Jeg synes artikkelen var nøytral, men den linker upcr til egfr på en slik måte at det for meg blir rart om ikke Travere får egfr reduksjon og godkjent?
Videre vil kanskje ikke calle de som blir påvist sykdom før 1.5g upcr i fremtiden slik at konkurrenter kan snappe de før calle, bremse utviklingen så calle aldri får dem. Det som taler mot dette de første årene er at medisinene er så dyre at det bare er de sykeste som får? Det er også en populasjon med allerede høy upcr som ikke forsvinner med det første
slettet
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Pareto er fortsatt bull, target 300.
Markedet er veldig uenig med Pareto
Bryan Garnier 190 SEK
Jeffries med 337 SEK (60$ for 2 aksjer)
Kempen 300 SEK
Penser 300 SEK
Swedbank 140 SEK
Pareto 300 SEK
Redeye 280 SEK (125 - 450 SEK)
Carnegie 133 SEK
SEB med nytt kursmål 80 SEK og ville spekulasjoner ut fra ekstrapolering av rare datapunkter.
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Calliditas: Clarification of recent publication feedback
2022-10-20
10:51
The Calliditas share price reaction suggests that the Kidney International publication feedback should result in increased uncertainty. The results are mostly in line with should be expected and a negative reaction is mainly justified if some investors has inflated expectations. The current Calliditas valuation suggests that this is a small minority of investors.
Johan Unnerus
Tarpey has conditional approval to treat IgAN patients with elevated proteinuria of UPCR >1.5g/g. Elevated proteinuria is a well-established biomarker for the more advanced stages of IgAN, where the risk of disease progression and declining filtration of eGFR is elevated.
In the Kidney International publication, there are some interesting insights in terms of baseline characteristics and especially in terms of patient sub-group dynamics. In IgAN, we should expect (based on earlier published studies) that a group of diagnosed IgAN patients with low levels of proteinuria (measured by either UPCR or UACR) has a low level of eGFR disease progression. The rate of eGFR decline increases much faster for patients with elevated proteinuria. The eGFR decline is very modest for patient’s with proteinuria < 0.99 g/g and even less (near nil) deterioration when < 0.33 g/g. The accelerated eGFR decline kicks in for the patient group in the 1-2 g/g range and accelerates further for patients beyond >2 g/g. The 1.5 g/g hurdle on Tarpeyo’s label corresponds with a level where the risk of progression is distinctly higher. Some confirmatory points from the Kidney International publication:
- The positive eGFR impact over 9m and 12m is confirmed for the subgroup of patients with UPCR of > 1.5g/g (some 37% of the patients)
- The positive eGFR impact over 9m and 12m was limited for patients with UPCR of <1.5g/g (some 63% of the patients)
The average level of UPCR was 1.21-1.27 g/g; hence, most patients were below or in the very early stage of the UPCR range, where eGFR levels started to deteriorate faster. It is very difficult/impossible for Tarpeyo to show a positive eGFR effect among patients with no or very limited eGFR deterioration. A large minority of patients in this study had UPCR levels below 1.0 g/g, where Tarpey should have limited positive eGFR effects, especially over 9-12 months. Among relevant patients (UPCR 1.5g/g and above), we can expect even more significant benefits from Tarpeyo in terms of UPCR reduction and eGFR progression. In real life, this is also the >1.5 g/g patient cohort where specialists will and should prescribe a product like Tarpeyo. This includes both Tarpeyo naive patients and future repeat patients (when UPCR eventually bounces back to a higher level) in our view.
The cost-benefit rationale is also related to if the patients are at risk of experiencing eGFR deterioration or not. The Kidney International publication does not provide meaningful feedback on when the second dose of Tarpeyo should be administrated, nor the proportion of patients that should be subject to a repeat dose. We expect that Part B of the study will provide information in this respect (Q1 2023). Will this be after 15, 18 or 24 months and for what proportion of patients?
The publication does also introduce some question marks in our view. Some aspects are more challenging to understand:
- The Tarpeyo benefit is higher among European patients vs North American patients
We note that the number of US patients in the active arm is 17. This is a very small number of patients, and the proportion of patients with a UPCR of >1.5g/g is even lower, possibly as low as below 7. A natural explanation is that this number could be even lower (a disproportionate number of US early disease patients) or just a random result. This is also something to look out for in the extended study.
- The positive Tarpey effect is higher among men vs women.
This is difficult to understand, and we note that there is a high number of men in the study (66%). This is also something to look out for in the extended part B study.
The publication suggests that the positive Tarpey result would probably be even better among a more representative patient group (included in the label). The treatment profile also indicates that the Tarpey effect will be higher for patients with elevated UPCR levels ( above 1.5 g/g and most likely even higher among patients >2.0 g/g). On the other hand, the results (in the same disease progression group) could be slightly softer with a 50/50 male vs women split. The publication provides no clues to assessing the long-term eGFR effect nor o the dynamics related to when to initiate repeat Tarpeyo dosage.
Based on the current very modest valuation, few investors seem to expect a dramatic future market expansion beyond the current Tarpeyo label. As a result, this recent adverse share price reaction on the back of this publication is probably a dramatic overreaction that can be an excellent opportunity to invest in Calliditas ahead of further launch and study support.
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