-12% ved godkjenning pga BBW…
jaja.
Helt drøyt regime som må følges før og under oppstart. Black box label pga. lever tox samt skadelig for gravide da toksisk for fetus. Man kan heller ikke bruke vanlige blodtrykksmedisiner (Ace hemmere og ARBs).
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Bull caltx! Ser noen spekulerer allerede om de kommer på markedet i det hele tatt??
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PAS:
Travere receives FDA approval, what does it mean for CALTX?
The FDA just announced that Travere Therapeutics’ drug Sparsentan received accelerated approval for the rare kidney disease, IgA Nephropathy, based on the surrogate endpoint of proteinuria (protein in urine). Yet, Travere’s stock is currently trading down -12% with large volume, how so? In contrast to Calliditas’ drug, the FDA has put restrictions (e.g. only available through a restricted distribution program because of multiple risks) and safety warnings into the label – see Travere’s Sparsentan label here vs. Calliditas’ Trapeyo label here . Zooming out of the restrictions and safety issues, the key question, is Sparsentan really going to halt the decline in kidney filtration rate associated with the disease or not remains. There is already strong (decline-halting) kidney filtration data from Calliditas’ drug (12-months effects follow-up after 9 months dosing) but nothing from Sparsentan, which is expected in 2H 2023, but we do not expect much due to the current data and baseline characteristics of Sparsentan’s trial – for more on that, please consult our note from last October . Rumors say, that Travere will try to price the drug well below Calliditas’ drug in an attempt to compete. Be it as it may, we modeled only 25% and 15% peak market share for Calliditas’ drug in the US and Europe, respectively – thus have accounted for multiple potential upcoming competitors such as Travere, Chinook and Novartis and others mentioned in our reports. For more on our view on Sparsentan please consult our note from last October . If Calliditas’ stock trades down on Monday, we believe that it poses an excellent buying opportunity ahead of expected strong numbers for Q4 to be reported by CALTX on Thursday. With that, we reiterate our Buy rating on CALTX with a target price of SEK 300.
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Hørte på webcasten. Fasinerende at Callidias og Tarpeyo ikke ble omtalt, hverken i presentasjonen eller under q/a sesjonen.
Merkelig. Ingen spørsmål fra analytikere engang?
Vet du forresten hvor de tar det fra at 90% av nefrologer sier de skal skrive ut preparatet innen det første året? Finner ingen poll / undersøkelse om dette
Nei, Kjenner ikke til de 90 prosentene. Men men den labelen som Travere har fått så er antalle av potensielle pasienter 30-50 000.
Spørsmålet er om både Calliditas og Travere kan få utvidet lavbel når 2 års data. er klare. Ikke lenge til vi får top line data fra Callditas på 2 års avlesning. Gitt at Calle blir cash positiv når q1 kommer i mai er det vel bare å sitte rolig å vente på en opptur
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“Filspari will be priced at $9,900 per month, making it cheaper than Tarpeyo’s cost of $14,160 per month or $170,000 a year. At least three analysts expected the list price of Travere’s drug to be between $70,000 and $100,000 a year.”
[…] “Jefferies analyst Maury Raycroft estimates that for the year, Travere could make about $35 million in 2023 from sales of the kidney drug. It is expected to have peak sales of $745 million in the United States. Travere expects to launch the drug by end of the month through its specialty distributors and specialty pharmacies in the United States.”
Da blir det spennende å se hvordan markedet vurderer dette relatert til Caltx;
kurs opp, ned eller uforandret?
Tror kanskje dette var nøytralt, og at markedet avventer Q4-presentasjonen på torsdag og en eventuell utvidelse av label etter 2 år for Caltx?
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RedEye 20. feb https://www.redeye.se/research/881218/calliditas-fda-conditionally-approves-traveres-sparsentan-filspari-as-expected
There will be two alternative IgAN therapies on the US market by the last week of February 2023 as the FDA gives the green light to Sparsentan. This is a tougher situation for the queue (the 3rd and 4th to the market behind Tarpeyo and FILSPARI) but no change in threat to Calliditas at this stage. We regard any adverse share price reaction as a buying opportunity on the back of this approval.
Travere’s FILSPARI is approved for patients with IgAN at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g, like Calliditas Tarpeyo. The approval comes with a boxed warning, REMS (Risk Evaluation and Mitigation Strategy), hepatotoxicity and birth defects. For IgAN patients, the hepatoxicity part is the most significant in our view, as these patients have impaired liver function per definition. The REMS requires specialists prescribing FILSPARI to monitor aminotransferases (by a blood test monitoring AST and ALT levels). FILSPARI should generally be avoided for patients with aminotransferases above three times normal levels.
FILSPARI will be launched by 27th February, and the initial launch will be monitored closely. Travere’s Q1 is due in early May. Travere is likely to target the primary and secondary Nephrologists in the US market with a sales force of some 80 FTE.
In our view, this is in line with our expectations. The mid to long-term market dynamics will be related to the ability to protect liver function and especially the long-term filtration effect (eGFR). Calliditas is on track to report long-term eGFR results in Q2 2023, and Travere expect to publish long-term eGFR results by Q4 2023.
In our view, it will probably be challengning for Travere to launch FILSPARI ahead of long-term filtration data. Specialists have plenty of experience with Tarpeyo, and FILSPARI delivers comparable proteinuria reduction. Tarpeyo also has the advantage of publishing promising nine and twelve-month eGFR results. In addition, there is the REMS and the hepatoxicity issue. In earlier studies, FILSPARI has resulted in critical AST/ALT levels for some 2.5% of patients, which may seem modest. However, the target population is, by definition, at risk of rapid disease progression, having failed to respond to earlier therapy. ALT/AST levels can come with flares, and a much more significant proportion of patients are likely to have reached unsettling levels earlier.
Patients above the upper range (typically 48-55) have a risk profile, and patients above twice the levels have a condition (mild elevation). The above three times are abnormal levels. In addition, the normal levels vary with age and health profile (like BMI). IgAN patients are often relatively young and should have relatively low levels. Our point is that some or many specialists are less likely to opt FILSPARI for patients with elevated levels well below the three-times upper level. Other specialists may regard a non-immunosuppressive alternative (remember that Tarpeyo is still immunosuppressive but with a significant reduction by approximately 90% compared with systemic corticosteroid) as principally interesting but may still opt to wait for eGFR results, real-life clinical experience and further evidence regarding FILSPARI’s hepatotoxicity profile.
The initial share price reaction (late Friday) was adverse for Travere on the back of the FDA’s green light. The initial share price reaction for Calliditas US listed ADS had an initial corresponding positive share price reaction.
At this stage, we do not make any positive Calliditas estimates or base case revisions. We point to Calliditas’ Q4 result, due on 23rd February later this week and Travere’s Q1 result, due in early May, possibly coinciding with Tarpeyo’s eGFR results.
We regard any initial adverse share price reaction for Calliditas on the back of FILSPARI’s conditional approval as a Buy opportunity. Our Base case value proposition is SEK 290 (Bull SEK 500 and Bear SEK 95).
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Og +19,5% neste handelsdag for Travere (tirsdag 21.2). Spennende med Q4 tall CALTX i morgen.
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Har vel ikke sett noe om tidspunkt for rapport/presentasjon Q4 i morgen?
Det vanlige er rapport/tall kl 07, webcast 14/14:30
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Hyggelig rapport i dag:
We achieved total revenues of SEK 802.9 million ($79.3m) for the year of 2022, which represent an increase of 250% compared to 2021, whereof SEK 372.2 million ($36.8m) was net sales of TARPEYO for the first 11 months of commercialization. We are immensely proud of this result, and we look forward to continuing to support the patient community with a drug which is designed to target the origin of the disease and thus help keep patients out of dialysis. We end the year with a very strong cash position of SEK 1,249 million ($119.7m) which reflects a successful non-dilutive capital raising approach, and we believe that we are, based on our guidance for TARPEYO, funded to profitability and well prepared to capitalize on growth and opportunities in 2023.
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Blir for mye styr med grønne tall og akkumulering av cash.
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Ikke for sent 
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Håper shorterne får blø i dag. Merker meg spesielt det positive forordet til CEO i dagens rapport, fin guiding 
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Og man forventer part B i midten av mars.
" We were very encouraged by the positive feedback from the many interactions during the conference and by the many discussions that took place about TARPEYO in various forums. It is clear from these interactions that as more eGFR data generally becomes available it will ultimately drive treatment decisions, as the goal of treating physicians is to protect kidney function rather than to address symptoms, and we are excited about being able to share long term eGFR data in 2023 as Part B top line data becomes available, which we hope to be able to announce around mid-March."
“We believe that strong topline data from the Part B from the NefIgArd trial could provide momentum to uptake as the long term eGFR data will provide additional insight into the potential for kidney protection and disease modification achieved by the TARPEYO treatment.”
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Fin overskrift i Dagens Industri - og fin sak også
Specialistläkemedelsbolaget Calliditas redovisar ett rörelseresultat på 32,5 miljoner kronor för det fjärde kvartalet 2022, jämfört med minus 222 Mkr under motsvarande period föregående år.
Uppdaterad: 23 februari 2023, 07:31 Publicerad: 23 februari 2023, 07:10
Nyhetsbyrån Direkt
Text
Resultat efter skatt låg på -3,7 miljoner kronor 2022 (-219). Resultatet per aktie uppgick till -0,07 kronor (-4,19).
Nettoomsättningen var 429 miljoner kronor (31,2).
Styrelsen föreslår att ingen utdelning lämnas för helåret 2022 i likhet med föregående år.
Calliditas Therapeutics spår en nettoförsäljning för läkemedlet Tarpeyo, vid behandling av den sällsynta njursjukdomen Iga-nefrit, i intervallet 120 till 150 miljoner dollar.
I svenska kronor skulle det motsvara cirka 1.214-1.518 miljoner kronor vid användandet av en genomsnittlig växelkurs för dollar/kronor på 10:12.
Calliditas väntas med den befintliga kassan på drygt 1,2 miljarder kronor ”vara fullt finansierade till lönsamhet och väl positionerande för tillväxt och ytterligare möjligheter under 2023”, skriver Renée Aguiar-Lucander i vd-ordet av bokslutet för 2022.
Calliditas har sett en ”betydande förbättring av rekryteringsfrekvensen i studien av setanaxib i huvud- och halscancer, medan PBC (primär gallkolangit-studien Direkts anm) fortfarande är utmanande”, skriver Renée Aguiar-Lucander vidare.
Biomarkörsdata från setanaxib i huvud- och halscancerstudien väntas under 2023 som tidigare meddelats.
Interimsanalysen av den så kallade Transform-studien för läkemedelskandidaten setanaxib inom PBC förväntas fortsatt under första halvåret 2024. Dessa resultat kommer att bestämma vilken dos av setanaxib som kommer att användas för fas 3-delen av studien. I augusti beviljades Calliditas en påskyndad registreringsprocess av den amerikanska läkemedelsmyndigheten FDA för setanaxib inom den sällsynta leversjukdomen PBC.
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