PHOTOCURE - On course to reach 2023 guidance
https://www.dnb.no/seg-fundamental/fundamentalweb/GetReports.aspx?file=CMP4_229527.pdf&Sid=1-9BF1FST
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Det er interessant at i kursmÄlet pÄ kr 95 har DnB ikke inkludert noen verdi fra Cevira, selv etter positiv resultat fra Fase 3, hvorfra fÞlgende siteres fra analysen:
âWe have not included any value from
the Cevira projectâŠâ
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No shit, DNB.
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PHOTOCURE
On course to reach 2023 guidance
We expect the company to reach its 2023 guidance of
product sales growth (including FX) of 17â20% YOY and
that absolute EBITDA will marginally exceed the upper
end of the guided NOK45mâ50m excluding business
development (B/D) costs. Ahead of the Q4 results (due
at 08:00 CET on 21 February), we reiterate our BUY and
NOK95 target price.
Set for strong Q4. Our sales forecast of cNOK133m is slightly above consensus,
mainly because we have included a USD2.5m milestone from Asieris, and implies total
product sales growth (including FX) of c17.5% for 2023, at the lower end of the guided
c17â20% product growth including FX but excluding milestones. The company
previously mentioned a potential large order in Q4, but as there has been no
communication on this topic, we assume the deal has been delayed and will not
materialise until Q1 2024 at the earliest. For 2023, we forecast EBITDA (excluding B/D
costs) of cNOK50.6m, marginally above the guidance of NOK45mâ50m.
Flex sales continue to decline in the US. As Karl Storz is not supporting or servicing
flexible cystoscopes anymore, we expect sales to continue to decline. This also means
that Q1 2024 will face tough comparables, as the decision to stop supporting the flexible
market was taken in late Q1 2023 and the quarter included a substantial share of flex
sales. However, this is well known in the market and should not come as a surprise.
Underlying operating costs (excluding B/D) should be stable YOY in Q4. However,
we still believe the company will see a c6â7% increase in operating expenses (in NOK)
due to FX headwinds. As regards B/D costs, we expect a low level in Q4 (as seen in
Q3), while we forecast an increase in operating expenses (excluding B/D costs) of c6%
YOY due to FX tailwinds.
No news regarding potential FDA down-classification of BLC technology. As far
as we understand, the ongoing FDA down-classification process did not move forward
in any tangible way in the quarter.
BUY and NOK95 target price reiterated. We have made relatively small changes to
our forecasts, with the main impact on 2023e, as we have increased the size of the Q4e milestone.
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Hej Norge
Rydelig rapport fra DNB Market 
FĂžlgende udsagn og kommentarer er frit fra hukommelsen.
Lister er ikke udtĂžmmende 
Hvad venter vi pĂ„ â og hvor lĂŠnge ??
Kom gerne med indspil
- Nedgradering af Scope ---- senest Q1 2025 (kan komme nÄr som helst)
- Efter nedgraderings godkendelse (FDA) â indsendelse til FDA fra Olympus/Wolff ect, ect for
godkendelse af Flex/rigide Scope for Cysveiw og BLC - Godkendelse af Hexvix (fase lll Kina, er indsendt for NDA godkendelse) -----forventet senest Q1 2025
- Indsendelse af Cevira data (fase lll kina) for NDA godkendelse ---- forventet Fast Track, og
godkendelse senest 90 dage efter ansĂžgning. - Indsendelse af Cevira data til FDA og Europa for godkendelse ---- forventet Fast Track og
godkendelse FDA senest 60 dage efter indsendelse. - OffentliggÞrelse af Cevira Data pÄ EUROGIN messe 13. - 16. Marts 2024
â ikke
lĂŠnge til. - Cysview og BLC snarlig godkendelse som SOC !!!
Og for mit eget vedkommende som mangeÄrig aktionÊr ser jeg frem til Q4 2023 !!!
- Overskud pĂ„ driften â BEMĂRK uden Millstones !!!
- Nedbringelse af Operating Expencees
- Markant flere udplaceringer af Scope
- Effekt i Europa Roadshow/Promotion med Rutebilen, kĂžrt Europa tyndt og brĂŠndt Euro af.
- Hvad blev der af de 100 forespÞrgelser pÄ Scope ???
- Ser vi nogen Dylan Hallerberg effekt ??
Nok af vente pĂ„ og tag vare pĂ„ â fĂžrste step 21. Feb 2024 (snart)
Dansken
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Mustang Capital Ăžker med 10 000 aksjer til 140 000 aksjer i PHO
Noen som har tilgang pÄ denne analysen fra Pareto?
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Ja, triggeren er q4 rapporten.
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For en grundig âanalyseâ av Pareto.
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âoppkommendeâ
solid norsk
Halvannen kalendermÄned med konsolidering over den forrige motstanden nÄ, 50 dagers snitt begynner Ä ta igjen kursen.
Morsom tidbit hvor nĂŠr Q4 rapport og 50 SMA tangering av trenden er.
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Jađ
De har ikke dekning pÄ Pho.
De skriver ogsÄ H2 2024: china NMPA approval.
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Nettopp, litt clickbait i hÄp om Ä hanke inn noen nye kunder.
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New Photocure White Paper addressing Inequality in Bladder Cancer Care and the importance of Real World Evidence
This new White Paper discusses how real world evidence and patient registries can play a part in supporting healthcare equality. It looks at how Photocure supports researchers with data, and at uncovering disparities in bladder cancer care and outcomes through findings reported from several recent real world bladder cancer databases and studies. Some ethnic groups were found to have poorer bladder cancer outcomes than others. Income also appears to be linked to outcomes. Further research will be needed in order to investigate these disparities as first steps towards greater understanding and more equal bladder cancer care and outcomes for all bladder cancer patients, regardless of background, race or gender.
Read the full white paper online: Addressing inequality in bladder cancer care â Why are there still disparities in bladder cancer care and outcomes?
And how can real world evidence play a part in supporting healthcare equality?
While randomized controlled trials are the gold standard in the assessment of the safety and efficacy of new therapies, disparities may exist between the outcomes we see from clinical trials and what we actually see in clinical practice. Photocure remains committed to bridging the knowledge gap that exists in bladder cancer care. The company has supported and worked closely with several patient registries to benefit from real world data, including setting up its own U.S. âBlue Light Cystoscopy with Cysviewâ Registry, established by Photocure in 2014 and projected to enroll 4,400 patients.
About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide â the 5th most common in men â with 1 720 000 prevalent cases (5-year prevalence rate)1a, 573 000 new cases and more than 200 000 deaths in 2020.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4
1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: https://gco.iarc.fr/today, accessed [January 2022].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295â300
4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder-cancer.html
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Er en del skriving om celleforandringer og konisering nÄ, men skal nok veldig mye til at et norskutviklet produkt blir attraktivt i norge desverre
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Ny klinikk oppfÞrt pÄ Cysview i lÞpet av natten.
Mercy Center for Performance Medicine
701 S. New Ballas Road St. Louis, MO 63141
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Asieris aksjen i fritt fall, -40% pĂ„ en mĂ„nedâŠ
Fortsatt solid mcap og langt hĂžyere enn Photocure.
Se pÄ FTSE China A 600 - Pharmaceuticals & Biotechnology
Indeks per nÄ i 13,459.48. Var ca 20,000 i 2023.
SĂ„ Biotech indeks Kina har falt mye. Med andre ord Asieris pluss/minus som indeks fall.
NÄ er helse et stort satsningsomrÄde for Kina.
Fremdeles priset til 6 milliarder NOK etter fallet, sÄ er ikke sÄ krise.
Ikke konkursprising for et prekommersielt selskap som de sier 
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Bruken av Cevira og Hexvix har heldigvis ikke noe sammenheng med aksjekursen pÄ Asieris Ä gjÞre.
Hele aksjemarkedet i Kina sliter. Asieris er ikke immun mot slikt, uansett hvor lovende det kan se ut.
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«After more than 20 phase 3 trials got underway in 2023, Merck is planning for even more this year, according to Dean Li, Ph.D., head of Merck Research Labs, on Thursday. Meanwhile, CEO Rob Davis says the company is hunting for more mid-sized deals.
«
Appetitten for fase III studier igangsetting er formidabel. Photocure har til og med «ferdig» fase III studier.
Photocure er sÄ heldig Ä ha to fase III studier med oppnÄdde endepunkter hvor det er sendt NDA og skal sendes NDA for en mulig markedstilgang.
Unikt med partnerskapsavtaler med milestones og royalties ved salg? Partner jobber med markedstilgang gj regulatoriske myndigheter. Finnes det andre biotekselskap med disse egenskaper til slik mcap?