CALTX Q-pres: Calliditas Therapeutics Q2 Report 2022
Det spekuleres på Discord i at det er en forsinkelse på innrullering, dosering og fakturering. I den rekkefølgen.
Det kan være ja. Fikk ikke fulgt presentasjon, kom det frem en forklaring?
Nope. Men det har kommet svar på Discord som tyder på at folk er misfornøyde fordi øknonomien ikke er bedre enn det som er vist og at forklaringen i stor grad bygger på at det tar tid fra at legen har foreskrevet medisin, til man får kranglet ferdig med den amerikanske helseforsikringen, til at man blir dosert og til at faktura blir betalt igjen.
Må være kortsiktige tradere og investorer som spekulerer i dette. Pengene kommer, bare litt senere.
Mener at 2. kvartsrapporten var meget bra, og fallet nå tror jeg bare er en kortsiktig overreaksjon. Også basert på at negativ TA som slo inn kortsiktig.
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Shorten økte med 600-700k aksjer i går…
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Da blir det mye som skal dekkes inn mot slutten av året når pengene for alvor begynner å rulle inn til Calle og man ser mot 2023.
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PAS: Last week, Calliditas Therapeutics released their Q2 report, which was in line with our expectations, yet it triggered a sell-off of around -15%. We believe that the stock will eventually recover as (i) the company is posting sales in line with larger companies that we used to model Tarpeyo’s sales, (ii) we do not expect competitor entry (Sparsantan) in November as the broader market seems to, why is explained under the 2nd title in this note and, (iii) the slight increase in cost was expected as function of increase in sales & necessary to catalyze Tarpeyo’s larger potential. We thus reiterate our Buy rating on CALTX with a target price of SEK 300/share.
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Interview med Renée. Alt er på skinner, og de gjør stort sett alt riktig i deres commercialisering.
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I det lange perspektivet kan man vel si det.
Men spørsmålet er vel om vi ser bunnen her langt nede på 80-tallet.
Tror selv på FOMO og at kursen stiger frem mot tallene som forventes ved Q3.
Gjort deg noen tanker rundt innruleringen etter to kvartaler med salg?
Pareto har forøvrig noen gode argumenter for at Sparsentan ikke umiddelbart vil bli godkjent i november:
Travere’s Sparsantan, the non-selling “soon to be competitor” as per market expectations (not ours)
The market seems to ignore several facts which we elaborated on in our initiation report from June 2nd. Below three bullets + a conclusion bullet on why we see Travere’s chances to get accelerated approval for Sparsantanin IgA Nephropathy as very slim.
• FDA’s comments and interactions with Reata Pharmaceuticals and Calliditas Therapeutics last year allow for insights in how the agency assesses such kidney disease targeted drugs. Both decisions were expectable also based on previous behavior. The FDA made clear that companies need to show good proteinuria and eGFR data with an adequate safety profile. Reata had bad proteinuria data but good eGFR data and bad safety data = rejected by FDA. Calliditas had good safety, good proteinuria, and good 9-month eGFR data = FDA asked for further analysis on eGFR (highlighting its importance despite the approval being on the surrogate / proteinuria),being at least part of the cause for the three months delay from September to December 2021 = FDA granted accelerated approval to Calliditas’ drug Nefecon.
• As noted in our initiation, Travere filed for accelerated approval in May 2022, not providing any eGFR data to the public despite having like Calliditas, 9-month follow-up data – also implying that the drug is likely weaker on this key endpoint than Calliditas’ drug. Instead, Travere press released the following sentence “ The Company believes that preliminary eGFR data available at the time of the interim analysis are indicative of a potential clinically meaningful treatment effect after two years of treatment.” We note, that “believes”, “preliminary”, “indicative” and “potential” are verbs and adjectives that create less confidence compared to posting clinically relevant and statistically significant eGFR data as Calliditas did from both phase 2 and phase 3 studies.
• On August 3, the FDA rejected Travere’s Sparsantan accelerated approval submission in another fibrotic kidney disease, focal segmental glomerulosclerosis (FSGS). What did the FDA note? The lack of eGFR data asdisclosed by Travere’s press release: “…the interim analysis from the ongoing pivotal Phase 3 DUPLEX Study conducted in 2021 together with the recent limited additional estimated glomerular filtration (eGFR) data-cut do not meet their threshold to support an application for accelerated approval in FSGS…” .
• Based on all this, it would be a surprise and change in the agency’s behavior to grant Sparsantan accelerated approval in IgA Nephropathy this November, thus we deem its chances to be rejected as very high and the question for relevant eGFR data remains even for the potential of a later possible approval and the possibleadoption by treating nephrologists.
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PAS i dag: Nefecon launched in Europe by partner STADA
Calliditas Therapeutics just announced the launch of Nefecon in Europe. It marks the first and only approved product for the progressive kidney disease, IgA nephropathy. The launch is already well underway in the US, run by Calliditas & producing Q2 2022 sales of USD 6.6m – the first full quarter post US launch. We see Calliditas stock as a top pick in the current market circumstances as it is still valued at a mcap of SEK 4,800m i.e. like a development-stage biotech. Yet, it has already a cash producing drug which it launched alone into a multibillion-dollar market that lacked an approved and effective drug. Further, we expect that the competitor Sparsantan (developed by Travere, former Retrophin) will be rejected by the FDA on November 17, due to lack of eGFR data as explained in our previous notes, and in the unlikely case it is approved, the USD >10 bn US + Europe IgA Nephropathy market is big enough for several drugs. We therefore reiterate our Buy rating on CALTX with a target price of SEK 300/share.
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Kursmål 190 SEK
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Kursmål her og kursmål der - det er spådd omsetning i billion dollar klassen og med en MCAP på ca. den størrelsesorden og høy fortjeneste så er vi vel der at en 2 og 3 dobling fort ikke blir nok så lenge de kan tjene inn dagens markedsverdi per år.
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Anekdotisk og ukjent opphav (mao verdiløst), men deler det nå her også:
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