Uhyre spennende selskap!

I dag også godkjenning i UK i tillegg til tidligere godkjenning i EU. I USA har de raskt økende salg siden de ble godkjent.

Dessuten spås den fremste konkurrenten på verdensmarkedet å ligge dårlig an med tanke på godkjennelse for sitt konkurrerende legemiddel.

Kursmål er her SEK 300.

Nefecon receives UK market authorization
Calliditas Therapeutics today announced that Nefecon, sold under the brand name Kinpeygo in Europe, received market authorization in the UK. This follows the EU commissions authorization granted in July 2022. The European pharma partner STADA will be responsible for the UK launch as for EU and Switzerland. Yet another milestone delivered by Calliditas and that in an eventful month. We expect the competitor Sparsentan to be either delayed or rejected by the FDA on February 17 or before if the agency does not suddenly change its behavior. If anyways approved, we see Sparsentan as a second choice due to lack of kidney filtration data and blackbox warning requiring a risk evaluation and mitigation (REMS) related to risk of liver toxicity (for more details on Sparsentan see our previous notes). In addition, we expect Calliditas to report 2022 full year sales of Nefecon around USD 43m. We reiterate our Buy rating on CALTX with a target price of SEK 300.***

Meget sterk rapport fra Caltx, som viser en enorm vekst i salgsinntekter. Et slikt biotechselskap hadde vi trengt i Norge!
Cash SEC 1,25 milliarder, og estimerte salgsinntekter for Tarpeyo på SEC 1,2-1,5 milliarder i år.

https://mb.cision.com/Main/16574/3722051/1869882.pdf
https://www.calliditas.se/en/year-end-report-2022/

Dette er helt fantastisk ! Og for en fremtidsutsikt !!

STOCKHOLM (Nyhetsbyrån Direkt) Specialistläkemedelsbolaget Calliditas redovisar ett rörelseresultat på 32,5 miljoner kronor för det fjärde kvartalet 2022 (-222).
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).

Fremover:

STOCKHOLM (Nyhetsbyrån Direkt) Specialistläkemedelsbolaget 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.

Calliditas er en klar opkøbs kandidat.
Man skal dog huske på, at der er mange andre produkter på vej, idet markedet er stort. Det taler selvfølgelig til fordel for Calliditas, eftersom de er foran de andre.
Normal statistik fortæller i det store perspektiv, at et enkelt Pharma selskab kan sætte sig på 25% af markedet, men det er også stort.
Aftalen i Kina kan give ret meget i royalty, idet man mener der er noget i stil med 5 millioner mennesker som kan drage fordel af Tarpeyo. Hvilken markedspris der kan hentes i det store rige, er svært at definere, men vi taler måske om 150 millioner USD om året i licens penge. Det er den store dark horse i min optik.
Ser man på igangværende forsøg, afventes resultat af et fase B forsøg i midten af marts i år. Det resultat kan gå begge veje, men ledelsen i Calliditas synes meget positive, men det skal man jo ikke lade sig snyde af.
Men:
Jeg tror at Calliditas opkøbes i år til en pris i nærheden af 320 SEK. Kommer B resultat hjem med gode data, kan kursen drives højere op.

Pas har kjøpsanbefaling SEC 300 etter dagens rapport.

Caltx ser ut til å stige raskt på Q4-rapporten. Opp 7% etter 15 min. handel.

Svært overbevisende resultater som vil gi permanent godkjenning i USA, Europa, og til høsten i Kina!

Calliditas Announces Primary Endpoint Successfully Met in Phase 3 NefIgArd Trial Evaluating Nefecon® in IgA Nephropathy
Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced positive topline results from the global, randomized, double-blind, placebo-controlled Phase 3 clinical trial NefIgArd, which investigated the effect of Nefecon (TARPEYO®/Kinpeygo® (budesonide) delayed release capsules) versus placebo in patients with primary IgA nephropathy (IgAN).

The trial met its primary endpoint with Nefecon demonstrating a highly statistically significant benefit over placebo (p value < 0.0001) in estimated glomerular filtration rate (eGFR) over the two-year period of 9-months of treatment with Nefecon or placebo and 15-months of follow-up off drug.
Supportive 2-year total slope analyses were statistically significant and clinically meaningful reflecting a sustained treatment benefit.
The eGFR benefit was observed across the entire study population, irrespective of urine protein-to-creatinine ratio (UPCR) baseline, which the company believes supports a regulatory filing for full approval in the study population.
UPCR reductions observed were durable, reflecting a long lasting treatment effect during the 15-month follow-up period off treatment.
“This is truly a great outcome for IgAN patients. This reflects sustained impact on kidney function across the entire study population with a treatment which was specifically designed to treat IgAN by downregulating pathogenic IgA1 antibodies at their presumed source and we believe this dataset supports regulatory filing for full approval based on the Phase 3 study population,” said CEO Renée Aguiar-Lucander.

“These data show the kidney function protection delivered by Nefecon and demonstrate that the approach offers patients a truly disease modifying treatment with sustained reductions in proteinuria over two years and continued eGFR benefit. Importantly Nefecon was well tolerated and together with the proteinuria and eGFR data mean that Nefecon has cemented its place as a key treatment option for patients with IgA nephropathy at risk of progressive kidney function loss,” said Dr Jonathan Barratt, Mayer Professor of Renal Medicine at Leicester University.

“These data establish that there is an option for patients with IgA nephropathy to specifically target their illness and to safely slow and delay progression of their kidney disease. The sustained effects on proteinuria and on eGFR are impressive and clinically meaningful,” said Richard Lafayette, Professor of Medicine (Nephrology) at Stanford University.

This data readout from Part B provides longer term data from the Phase 3 NefIgArd trial, which read out topline data on Part A in November 2020. An additional 29 Chinese patients, required for local Chinese regulatory purposes only, are expected to complete Part B in Q3, 2023. Based on the Part A data, Calliditas received accelerated approval from the U.S Food and Drug Administration (FDA) in December 2021 and conditional marketing authorization from the European Commission (EC) in July 2022, marking the first time a drug was approved for the treatment of IgAN in the US and the European Economic Area (EEA). Nefecon is being marketed by Calliditas in the US under the brand name TARPEYO®, and by STADA Arzneimittel AG in the EEA, Switzerland and the UK under the brand name Kinpeygo®.

“I am delighted with the positive outcome of the NefIgArd trial. This important milestone is the culmination of many years of hard work and dedication from so many people involved in the study. I would like to extend my thanks in particular to the investigators and site staff involved in the study, as well as of course the participating patients,” said Calliditas’ CMO, Dr. Richard Philipson.

On the basis of this data, Calliditas plans to file for full approval from the FDA, and support filing for full approval with EC and UK MHRA during 2023 for patients with primary IgAN based on the Phase 3 study population.

NefIgArd Topline Results

The analysis included 364 patients diagnosed with primary IgAN and who were on a background of optimized and stable renin-angiotensin system (RAS) inhibitor therapy. The patients were randomized in a 1:1 ratio into one of two treatment groups – Nefecon 16 mg/day orally or placebo – and treated for 9 months daily, and then monitored for 15 months off-drug.

eGFR Data

The key primary endpoint, eGFR over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon compared to placebo (p<0.0001). Mean change in eGFR over the 2-year period was -2.47 mL/min/1.73 m2 for Nefecon 16 mg versus -7.52 mL/min/1.73 m2 for placebo.

Safety Profile

The results indicate that Nefecon was generally well-tolerated and the safety profile was consistent with that observed in Part A of the trial.

Trial Design

The global clinical trial NefIgArd is an ongoing Phase 3, randomized, double-blind, placebo- controlled, multicenter study to evaluate the efficacy and safety of TARPEYO 16 mg once daily vs placebo in adult patients with primary IgAN as an addition to optimized RAS inhibitor therapy.

Part A of the study included a 9-month blinded treatment period and a 3-month follow-up period. The primary endpoint was UPCR, and eGFR was a secondary endpoint. Part B included a 12-month observational period off drug and assessed eGFR over the entire 2-year period for patients who were treated with the TARPEYO or placebo regimen in Part A in a total population of 360 patients.

The trial met its primary objective in Part A of demonstrating a statistically significant reduction in urine protein creatinine ratio (UPCR) or proteinuria after 9 months of treatment with 16 mg once daily of TARPEYO compared to placebo. Patients taking TARPEYO plus RAS inhibition (n=97) showed a statistically significant 34% reduction from baseline vs 5% with RASi alone (n=102) at 9 months, resulting in UPCR reduction of 31% (16% to 42%) p=0.0001.3

At 9 months, there was a 3.87 mL/min/1.73 m2 difference in eGFR absolute change with TARPEYO plus RASi vs RASi alone (-0.17 vs. -4.04).4

Topline data of the NefIgArd study were reported on March 12, 2023 in which the primary endpoint of eGFR was met as per above. The trial is expected to conclude in Q3 of 2023 when the final 29 patients in China (not required for global submission purposes) have completed 9 months of treatment and 15 months of observation.

Conference Call

The Company will host a live webcast for investors on Monday 13 March, 2023 at 8 A.M. ET (13:00 CET).

Interested participants may register for the webcast here: https://lifescievents.com/event/calliditas-webcast/

Phase 3 Part B readout positive, enabling full FDA/EMA approvals
On Sunday evening, Calliditas announced a statistically significant and clinically meaningful topline Part B readout from the Phase 3 NefIgArd trial. The company is the first and only in the world to report such positive, disease-course changing data in the progressive and deadly kidney disease IgA Nephropathy. The data will enable full approval in the US and Europe while further boosting already accelerating sales this year. Meanwhile, it will make it tougher for the competitor Travere Therapeutics (TVTX), which has only biomarker data (no data on the kidneys) and instead lots of safety related concerns, as we previously highlighted (& in older releases). With these positive developments and despite the initial underinvestment in its sales force, we deem the stock as one of the best biotech picks for 2023 due to (i) no remaining clinical risk, (ii) fast-increasing sales and (iii) trading at x3.3/x1.1 of 2023/24 sales with an EBIT margin of 60-70%. We reiterate our Buy rating on CALTX with a 12-month target price of SEK 260. Calliditas will hold a webcast tomorrow (Monday) at 13:00 CET.

Sustainable effect on kidney filtration rate was observed at 24-month (after 9 months of dosing)

The key kidney filtration data (eGFR) over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon compared to placebo (p<0.0001). This further validates the sustainable disease-halting effects of Nefecon as the eGFR difference versus placebo has broadened from the Part A readout at 9-month (3.87 mL/min/1.73 m2). The company also reported durable proteinuria (UPCR) reductions and consistent safety profile. We believe such good data will allow Tarpeyo to eventually obtain full approval from the US FDA. Simultaneously, we can see that eGFR decline is halted while on treatment (9 months) and then the effect slowly wanes off after months without Nefecon. As a result, patients will have to get back on the drug after a pause and thus will likely need chronic treatment (as expected for an autoimmune disease).

I den grad man kan snakke om en trygg vinner i pharma markedet er calliditas en. Denne kommer til å doble seg i løpet av et år

Utrolig spennende intervju med CEO. Lite tvil om at denne aksjen kommer til å stige

https://www.youtube.com/watch?v=Jg_OgAQ1JzM

Kjøpsmulighet !!!

En fallende kniv nå etter litt skuffende 1. kvartal.
Det er også signalisert svakt salg i april så man får avvente Q2 tror jeg.

De to viktigste triggerne er godkjenning fra Kina ( hvilket alt jeg leser kommer de til å få) og salg. Kina er verdens største marked for den type medisiner. Og salget kommer. Derfor tror jeg dette tidspunktet etter det kortsiktige fallet er en enorm kjøpsmulighet.


Calliditas is a commercial stage biopharmaceutical company based in Sweden. Its first product Tarpeyeo has been selling in the US and its sales are doubling every quarter. European sales should start in 2023 with EU partner Stada "becoming the first and only approved medication for IgA nephropathy in EU for patients with primary IgA with rapid disease progression" (see: https://www.calliditas.se/en/wp-content/uploads/sites/2/2022/11/calliditas-q3-2022-presentation.pdf
We bought into the story late last year with average price around SEK90. Current share price is around SEK100.
Redeye states in their research that the base case valuation of SEK280 should be reached within 12-24 months. Pareto Securities views Callidias as one of the most interesting companies in the Swedish pharma universe.
Redeye Research Summary:
Positive triggers ahead
Redeye updates its outlook on Calliditas, anticipating US launch support and the European launch over the next 12 months, along with long-term study support for Tarpeyo and feedback from the competition. We increase our Base Case to SEK290 (280) with a Bull Case of SEK500 (450) and a Bear Case of SEK95 (125). Current share price is SEK100
Support from the Tarpeyo launch
We expect Tarpeyo to reach SEK3,557m in sales in the US as early as 2024e. We are confident thanks to the supporting scientific evidence to date and its ability to secure a high degree of coverage and reimbursement less than nine months since launch. For 2023, we point towards the expanded specialist sales team, support from the long-term eGFR outcome, and the pending European launch (under trade name Kinpeygo).
Future competition needs to clear a high bar
Tarpeyo has already established the most important competitive advantages:
first-mover advantage, an expanding body of clinical specialist experience, a safe product, and solid efficacy. This puts it in a good position to extend its lead once the results from the NefIgArd Part B study are released in H1 2023.
Valuation
We point to 200% upside to our Base Case of SEK290, although the timing for this depends on the equity market, the emerging competition, and Tarpeyo launch support. In our view, Calliditas has the advantage of a favourable status quo, in which no news is good news.
Full research available below for free:
Click to access calliditas_january_20231.pdf

Utrolig god progose fra FIT Investment Ideas: Øker målet til kr.463

Calliditas Therapeutics
Calliditas reported last week sales below consensus. As a result share price was down by 30%. We have increased our position by 50% on the weakness.
Slow Q1 sales but positive signs lead to a stronger Q2 - According to the company, the weak Q1 sales were a result of low enrollments in January, partly due to many patients changing their insurance plans. However, March reported a record number of 408 newly enrolled patients (+30% from Q4), indicating the further growth of sales. On average it takes one month to convert enrollment into sales. Q2 sales should be very strong.
The company has no real competitor in the market. The sales are expected to accelerate every quarter.
The approval in China is expected in H2 2023 with a milestone payment. In China IgA Nephropathy is much more common disease than in western world where Calliditas is starting to sell now. China approval could be a material game changer.
Pareto has a fair value target of SEK 463 per share - 450% upside from current share price of SEK 100.

A good summary of the opportunity created by the latest selloff

https://fitinvestmentideas.com/2023/05/22/scandinavian-opportunities-for-this-week/

Calliditas Therapeutics has been selling in the US since 1Q23. Its annualised sales exceed USD100 million. Not a bad product launch. Two material catalysts expected in Q4 - China approval and full US approval. Both should accelerate sales growth.

Full investment thesis and Carnegie summary:
https://fitinvestmentideas.com/2023/10/20/carnegie-on-calliditas-us-and-china-approvals-due-in-q4/

Pareto research today: Calliditas is the only safe and efficient drug after Novartis Drug failure announced today

Calltitdas FDA approval scheduled for the next week - December 20.

Callitidas has been selling for over a year based on FDA preliminary approval. Analysts claim the approval is almost given - very low risk.

Callitidas gaining every day. 110 SEK now, my target before the FDA approval is 120 SEK, and 140 SEK after the approval. Any views?

Mer positive nyheter::

Läkemedelsbolaget Calliditas meddelar positiva resultat från open-label förlängningen av fas 3-studien NefIgArd. Det framgår av ett pressmeddelande.

Studien visade ett behandlingssvar som överensstämde med NefIgArd-studien för effektmåtten urinprotein till kreatinin-ration (UPCR) och uppskattad glomerulär filtrationshastighet (eGFR) efter 9 månader för samtliga patienter, inklusive de som tidigare behandlats med Nefecon i NefIgArd-studien.

"Det är spännande att se dessa resultat för både reduktion av proteinuri och stabilisering av eGFR efter 9 månader över alla patienter, oavsett tidigare behandlingsregim i fas 3-studien. Dessa topline-resultat stödjer studiens tes att svaret på återbehandling med Nefecon inte påverkades av tidigare behandlingscykler. Vi ser fram emot att presentera data vid det kommande ERA EDTA symposiet", säger vd Renée Aguiar-Lucander.

Fantastisk oppdatering:

Calliditas entered 2024 with a strong Tarpeyo patient enrollment. With the support from the new label, we expect another strong performance in Q1, and at this stage of the full expanded launch, we view patient enrollment as the lead indication. We expect Calliditas to take a more proactive approach to the 2024 guide as the launch progresses, with added Tarpeyo support from upgraded formulary listing status, the OLE study and the KDIGO revision later in 2024. Our base case valuation is SEK 270 (270), a Bull Case of SEK 390 (390) and a Bear Case of SEK 70 (70).