Noen som har en god forklaring på hvorfor den falt så mye på børsmeldingen?
Du kan lese innleggene i småprat tråden pg danne deg et inntrykk/bilde selv 
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Update - PhotoCure (Pharm. & Biotechnology, Norway)
Recommendation: Buy
Price target: NOK 87.00
Important long-term deal
For the Q2 report (due at 08:00 CET on 7 August), we expect earnings to be in line with our estimates and thus have not changed our forecasts. Focus should be on long-term growth and the deal with Richard Wolf regarding the development of a new flexible blue light cystoscope for the global markets. We believe such a product could be ready for launch in about two years, and the cost to Photocure should be reasonable. We reiterate our BUY and NOK87 target price.
Q2e revenue of cNOK144m and EBITDA of cNOK27m. Our revenue estimate is in line with last year, and in both this year and last year’s Q2, total revenue and EBITDA benefit from milestone payments. For Q2, we forecast cUSD2m in milestones (cNOK21m for the year). Underlying product sales should be flattish to slightly down YOY in the US (due to flex sales in Q2 last year that will not recur), while we forecast healthy growth in Europe. The positive EBITDA is mainly driven by the milestone payment and relatively low business development spending YOY in Q2.
Long-term development deal with Richard Wolf (RW) for flex BLC. In Q2, Photocure announced a deal with RW to develop a new flexible blue light cystoscope (BLC) for the global market. Photocure has sought such a deal for some time and, in our opinion, this is a positive move. We estimate the development of the new system would take around two years before it could be filed for approval (given that the US market has been down-classified until then). Photocure would support the development with its knowledge within BLCs as well as financially (i.e. taking some of the development costs). We believe the total cost for Photocure is reasonable (we estimate cNOK25m total cost over the coming years). In exchange, it would receive a royalty on sales of the flex BLC (we estimate a mid-teens royalty). However, the real benefit to Photocure would come from the potential increased usage of Hexvix/Cysview from its use in the outpatient setting.
BUY and NOK87 target price reiterated. Long-term we believe Photocure is working to establish BLC usage as a standard of care in most markets and the potential to reintroduce flexible BLCs in the US, and over time establish flex BLC as a standard in Europe, would expand the potential for Hexvix/Cysview significantly, in our view.
Best regards
Patrik Ling | DNB Markets | Equity Research Sweden
Phone: +46 733 26 37 69
Email: patrik.ling@dnb.se
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Photocure ASA: Invitation to presentation of second quarter and first half year 2024 financial results
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SHANGHAI, Aug. 28, 2024 /PRNewswire/ – Asieris Pharmaceuticals today released its 2024 Semi-Annual Report, showcasing a strong growth momentum. The launch of its blockbuster product APL-1702 is progressing smoothly, while the Commercial Team continues to enhance revenue-generating capabilities. The company’s pipeline is advancing and broadening, currently with 13 major products and 18 ongoing research projects. As of the end of this reporting period, Asieris had approximately RMB 2.024 billion in cash, cash equivalents, and financial assets held for trading, ensuring ample capital for the company’s continued growth and expansion.
Advancing Launch of APL-1702 to Meet Strong Demand for Non-Invasive Treatment of Precancerous Cervical Lesions
The new drug application for APL-1702, a combination of drug and medical device designed for photodynamic non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL), was accepted by the National Medical Products Administration (NMPA) in May 2024. The review process is progressing smoothly.
APL-1702 is a groundbreaking product that combines innovative, clinical, and social value. As a first-in-class treatment to be debuted in China, backed by proven efficacy in an international phase III trial, it is poised to become the world’s first non-invasive therapy for HSIL. Clinically, APL-1702 is set to redefine the treatment paradigm of precancerous cervical lesions, moving beyond the one-size-fits-all approach of cervical resection. It aims to reverse disease progression while preserving the cervix, avoiding damage from resection, and supporting long-term management and recurrence prevention. From a societal perspective, managing HSIL patient is a crucial step in the “early diagnosis and early treatment” of cervical cancer. APL-1702 combines the value of early cervical cancer intervention and the promotion of a fertility-friendly society, and it is expected to contribute to the success of the Action Plan for Accelerating the Elimination of Cervical Cancer (2023-2030) and the Healthy China Initiative.
To support the commercialization of APL-1702, the company formally established the Women’s Health Business Unit in early 2024. This unit is responsible for the domestic commercialization of APL-1702 in the Chinese market and expanding the company’s gynecological pipeline. Key members, including the BU head and teams for marketing, government affairs, and regional commercialization, have already come on board, all bringing extensive experience in gynecology and multinational pharmaceutical companies. In the first half of this year, the Women’s Health Business Unit conducted thorough market and industry research, developed a key launch plan for APL-1702, and actively prepared the commercial supply chain to ensure the product’s rapid market availability following its approval.
The company has also convened three expert consultation meetings focusing on key topics such as review and dissimilation of phase III clinical data of APL-1702, the current state of HSIL diagnosis and treatment, and clinical needs. The meetings garnered strong endorsements from the principal investigators and leading national gynecologists, highlighting the innovation and clinical value of APL-1702. With this expert backing, the Women’s Health Business Unit is pursuing strategic partnerships with government departments and industry associations to advance cervical cancer control and help shape a long-term management framework for precancerous lesions. Preparations are well underway, and a cooperation agreement is expected to be signed and implemented in the second half of the year.
Given the scarcity of innovative drugs in gynecology, APL-1702 stands out with its solid clinical evidence and proven efficacy. Moving forward, the company will leverage APL-1702 and its drug-device combination platform to build a robust gynecological portfolio through external partnerships, indication expansion, and proprietary second-generation products.
Commercial Capabilities Continue to Strengthen: Operating Revenue Increased by 130.98% from Q1 to Q2
Alongside strong commercialization performance, the Oncology Business Unit is actively preparing for the launch of new products. The new drug application for APL-1706 , a diagnostic and management agent for bladder cancer, was accepted in November 2023. Currently, APL-1706 is the world’s only imaging agent approved to assist bladder cancer diagnosis or surgery. It has passed inspection by the Center for Food and Drug Inspection (CFDI), with NMPA approval expected by the end of June 2025.
The Oncology Business Unit is refining a launch plan for APL-1706, exploring opportunities beyond surgical applications, such as outpatient examinations and strategic partnerships. The aim is to broaden market reach and benefit more patients. The team is developing strategies for post-launch access, pricing, expert endorsement, clinical collaboration, and dealer networks.
Additionally, the company will build on its strong brand positioning with a strategy that combines in-house research and in-licensing, will actively pursue external partnerships to further enhance its commercial competitiveness and strengthen its position in oncology.
Commit to Innovation and Drive Pipeline Expansion and Development Worldwide
Guided by its strategy, Asieris has made significant strides in multiple clinical development programs in the first half of the year, with a strong push for global presence.
In the field of women’s health, following the positive results of the international phase III trial for APL-1702 and recognizing the substantial unmet clinical needs, Asieris plans to submit a pre-submission to the European Medicines Agency (EMA) in the fourth quarter of 2024. It also aims to be in discussion with the US Food and Drug Administration (FDA) this year on the design of a pivotal clinical program for the North American market and will apply for a phase III trial in due course. The company has also begun development of the HPV clearance indication.
Dr. Kevin Pan, Founder, Chairman and CEO of Asieris Pharmaceuticals, commented, “We remain optimistic and confident about the future of Asieris. The launch of our two core products, APL-1702 and APL-1706, is on track and set to address critical unmet medical needs in their respective fields. This progress underscores our commitment to clinical value generation and ensures that patients will soon have access to our innovative products. We also saw strong growth in commercialization, reduced operational costs, and increased efficiency in the first half, showcasing our ability to meet strategic goals. Looking ahead, we will remain focused on genitourinary tumors and women’s health, aiming to deliver even greater value to both society and our shareholders.”
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Dette er positive nyheter
Upper tract carcinoma behandling kan bli et viktig tilleggsområde for Hexvix/Cysview.
If the cancer extends through the bladder to the surrounding tissue or has spread to nearby lymph nodes or organs, the five-year survival rate is 39% . If the cancer has spread to distant parts of the body, the five-year survival rate is 8%.
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Litt av en børsuke for Photocure!
Asieris halvårsrapport var det som skulle til. Troverdigheten og gjennomføringsevnen til Asieris synes høy. De betaler punktlig milepælen til Photocure. De har en solid økonomi.
Med Asieris forsikring om at gjennomføringen er on track og at Cevira er blockbuster reduseres risiko sterkt.
Det bør gjenspeiles i aksjekursen til Photocure som ligger på et svært lavt nivå. Den forsiktige oppgangen vi nå har sett endrer ikke på at aksjen fortsatt er svært billig og et klart kjøp.
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Kommende Events
International Bladder Cancer Group, September 19-21 in Bern, Switzerland
Specialty Networks UroGPO Bladder & Kidney Cancer Academy 2024 Summit October 24-26, 2024 Philadelphia, PA, USA. https://www.urogpo.us.com/events/
DGU: The 76th Congress of the German Society of Urology, October 25-28, 2024 in Leipzig, Germany
AFU: 118e Congrès Français d’Urologie, November 20-23, 2024 in Paris, France
Society of Urologic Oncology 2024 Annual Meeting (SUO) December 4-6, 2024 in Dallas, TX, USA. Upcoming Meetings :: Society of Urologic Oncology
BCAN Bladder Cancer Patient Summit September 20-21, 2024 in Philadelphia, PA, USA.
https://www.photocure.com/investors-hub/investors-events-and-presentations
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Kina vil ytterligere akselerere gjennomgangen og godkjenningen av innovative legemidler og medisinsk utstyr som er presserende nødvendig i klinisk praksis
Tid: 2024-09-13 Kilde: Xinhua News Agency
Li Li, direktør for State Food and Drug Administration, sa 13. september at han ville fremskynde gjennomgangen og godkjenningen av innovative legemidler og medisinsk utstyr som er presserende nødvendig i klinisk praksis, inkludere kvalifiserte produkter i den prioriterte gjennomgangs- og godkjenningsprosessen, forkorte fristen for teknisk gjennomgang, registreringsverifisering, registreringsinspeksjon og andre lenker, og øke hastigheten på godkjenningen.
Dette ble introdusert av Li Li på en rekke pressekonferanser om temaet “Fremme utvikling av høy kvalitet” som ble holdt av informasjonskontoret til statsrådet samme dag. Fra januar til august i år godkjente State Food and Drug Administration 31 innovative legemidler og 46 innovative medisinske enheter, en økning på henholdsvis 19 % og 12 % i forhold til samme periode i fjor.
Li Li sa at State Food and Drug Administration vil fortsette å øke sin støtte til farmasøytisk FoU og innovasjon, styrke tjenesteveiledningen i gjennomgang og godkjenning, inspeksjon og verifisering av innovative legemidler og medisinsk utstyr støttet av staten, og veilede bedrifter til å følge kliniske verdiorienterte og pasientsentrerte FoU-strategier; Styrke den politiske publisiteten og den tekniske konsultasjonen av produktregistrering og deklarasjon, integrere den tekniske styrken til nasjonale og provinsielle legemiddelreguleringsavdelinger, etablere kommunikasjonsmetoder på flere kanaler og flere nivåer, og bruke nettkanaler for å drive et skyklasserom for gjennomgang og godkjenning av legemidler og medisinsk utstyr; Forbedre tilgjengeligheten til innovative legemidler og medisinsk utstyr, implementere beslutningstaking og distribusjon av partiets sentralkomité for å utdype den koordinerte utviklingen og styringen av de “tre medisinene”, og aktivt støtte innovative legemidler og enheter for å komme inn på sykehus og medisinsk forsikring.
Samtidig vil effektiviteten av gjennomgang og godkjenning forbedres, fristen for underforstått godkjenning av kliniske studier vil bli forkortet, og pilotprosjekter vil bli gjennomført i Beijing, Shanghai og andre steder, for å redusere fristen for gjennomgang og godkjenning av kliniske studier av innovative legemidler fra 60 virkedager til 30 virkedager. Optimaliser gjennomgangs- og godkjenningsprosedyrene for supplerende legemiddelsøknader, gjennomfør pilotprosjekter i kvalifiserte provinser, gi verifisering av endringsregistrering etter markedsføring og inspeksjonstjenester for legemidler, og reduser fristen for gjennomgang av supplerende søknader betraktelig.
I tillegg vil det også støtte åpningen og samarbeidet med farmasøytisk industri, styrke transformasjonen og implementeringen av internasjonale generelle regulatoriske regler i Kina, støtte utviklingen av internasjonale multi-senter kliniske studier, og fremme synkron forskning og utvikling, samtidig anvendelse, samtidig gjennomgang og samtidig notering av globale legemidler i Kina; Utforske den segmenterte produksjonsmodellen for biologiske produkter, og gjennomføre pilotprosjekter for segmentert produksjon av innovative og klinisk presserende biologiske produkter i noen regioner; Vi vil øke støtten til import- og eksporthandel med legemidler, fremskynde godkjenningen av nye legemidler som er markedsført utenlands i Kina, og oppmuntre multinasjonale selskaper til å overføre originale kjemiske legemidler, biologiske produkter og avansert medisinsk utstyr til innenlandsk produksjon. Forbedre de relevante retningslinjene for salgssertifikater for legemiddeleksport, og oppmuntre flere farmasøytiske selskaper i Kina til å gå utenlands.
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Cevira (APL-1702): Photocure Partner Asieris Unveils Efficacy Data of Non-Surgical Treatment of Cervical HSIL at the 2024 PDT&PD Conference
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This study is a prospective, randomized, double blind, placebo controlled, multicenter phase Ⅲ clinical study, which has reached its primary efficacy endpoint and exhibited good safety.
Furthermore, the study results indicated that the pathological regression rate (defined as the proportion of subjects with a pathological regression to CIN1 or normal tissue) at the 6th month in different age subgroups, both the “≥20 and <30 years” subgroup and the “≥30 and <40 years” subgroup showed an increase of 15% to 20% in the pathological regression rate in the APL-1702 group compared to the placebo (PBO) control group. No cervical cancer events were reported, suggesting a significant therapeutic potential of APL-1702 in the HSIL population aged 20 to 40 years.
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