Diskusjon Triggere Porteføljer Aksjonærlister

Photocure fundamentale forhold (PHO)

For / mot / avgitte / avstår.

Betyr ikke dette at 13.2 og 13.3 ble vedtatt? Altså feil i referatet.

Photocure_ASA_Minutes_from_AGM_2024.pdf (709,6 KB)

Jepp, derav mitt forbehold om skrivefeil. Mao. er det ikke noe «overraskende» fra GF allikevel. 10 % er en standard fullmakt, her ble det vedtatt 15 % og 20 % ble så vidt nedstemt. Insentivprogram godkjent.

Ja, nogle gange giver det god mening at læse §12 før §13.
Norwegian havde vist også en emissionsfuldmagt på 10% engang. Her er Photocure så ikke i dag.

Det var feil i referatet ang. Emisjonsfullmakten for et år siden også. Endte med at de sendte ut ny børsmelding med nytt referat. Slurv fra CFO.

Photocure Announces Mobile BLC Tower Initiative to Expand Access to Cysview in the U.S.

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Utover at dette er en relativt stor ordre for Photocure, er kanskje den beste delen av dette at mange flere sykehus får anledning til å bli kjent med SaphiraT BLC-utstyr og hvor bra dette er sammenlignet med alternativene. Jeg tror dette er startskuddet på noe som kan bli veldig stort også i USA.

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Photocure and Richard Wolf Enter into Agreement to Develop a High-Definition Flexible Blue Light Cystoscope for Global Commercialization

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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 :+1:

DNB Logo
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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Photocure ASA: Results for the second quarter of 2024

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Photocure_Q2_2024_transcript – Kopi.pdf (136,6 KB)

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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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https://photocure.com/news/new-publication-blue-light-cystoscopy-shows-potential-to-facilitate-the-diagnosis-of-cis-in-the-upper-urinary-tract-108?utm_source=email&utm_medium=email_campaign&utm_campaign=newsletter

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Dette er positive nyheter

https://www.sciencedirect.com/science/article/pii/S2214442024001955

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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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