Photocure fundamentale forhold (PHO)

[Dreamliner]

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

[h3nk1]

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.

[anon63660786]

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.

[Lucrum]

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.

[TekBot]

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

Press Release - Oslo, Norway, June 4, 2024: Photocure ASA (OSE: PHO), the
Bladder Cancer Company, today announces that it has commenced activities to
support a new initiative enabling U.S. Hospitals and Clinics to offer blue light
…

Vis børsmeldingen

cystoscopy (BLC[®]) using a mobile capital equipment model. The initiative is
aligned with a recently executed agreement between Karl Storz and ForTec
Medical, aimed at providing on-demand SaphiraT BLC equipment to hospitals in the
U.S. leveraging ForTec’s utilization-driven mobile equipment business model.

The mobile tower opportunity is intended to increase access to BLC by reducing
or eliminating the need for capital budget approvals and instead, enables
hospitals to utilize operating budgets to bring the benefits of BLC with
Cysview[®] to their physicians and patients. In some hospitals and clinics in
the U.S., capital budget priorities have become a rate-limiting factor for
purchasing and adopting SaphiraT equipment to improve TURBT* procedures and the
management of patients with bladder cancer.

ForTec has initiated procedures in select territories with the 6 Saphira towers
that it currently has in the field, and an expanded rollout of the program
throughout the U.S. is anticipated to commence in the third quarter of 2024 with
12 additional Saphira towers that ForTec is preparing for deployment.

ForTec focuses on the urology treatment segment, and is equipped to provide real
-time capital equipment from its warehouses across the U.S. With ForTec’s
facility network located within 3 hours of >90% of all U.S. operating rooms, and
its sales force covering the 48 contiguous states in the U.S., the mobile BLC
tower opportunity has potential to significantly increase access and utilization
of BLC with Cysview for TURBT procedures. In preparation for the national
rollout, ForTec, Photocure, and Karl Storz will hold joint training and planning
sessions among their commercial organizations.

Under the mobile tower business model, hospitals or physicians can contact
ForTec to schedule cases. Once scheduled, ForTec will deliver the equipment the
day before the procedure for proper set up and care. A ForTec technician is
present during all surgical procedures. Once the procedures are completed for
the day or rental period, ForTec will return the mobile tower to its local depot
for servicing and quality control in advance of the next deployment. At any
given point in the delivery of care, Photocure, Karl Storz and ForTec will
collaborate to ensure seamless service. The per case business model has
additional benefits such as roughly doubling the number of field-based account
managers between Photocure and ForTec, marketing the use of BLC with Cysview to
ForTec’s vast customer network, and ensuring that trained technicians,
functioning equipment and parts are always available on-site.

“We are very pleased that the SaphiraT mobile tower program is planned for
expansion and is expected nationally throughout the remainder of the year. In
our discussions with customers, we saw that Urologists understood the clinical
value of BLC with Cysview but in many cases, were limited by a lengthy capital
equipment approval process. Additionally, this opportunity allows Photocure
access to major hospital systems as ForTec has successfully contracted with
national GPOs and opens the opportunity to expand the installed base of BLC
throughout the United States. Photocure continues to work towards ensuring
better access to quality bladder cancer care and this partnership demonstrates
that we are implementing proactive strategies to improve that access,” says
Geoff Coy, Vice President & General Manager North America at Photocure.

“Collectively all three organizations will be highly focused on driving
utilization of BLC with Cysview through this mobile solution. Hospitals will be
able to provide BLC with Cysview on a per-case-basis which allows the expense to
fall within an operational budget instead of a capital budget. Once the
hospital’s capital budget frees up, hospitals may choose to acquire the SaphiraT
tower permanently.” Geoff Coy concludes.

“For over 35 years, ForTec has been successfully providing mobile technologies
to customers nationwide for urology and 10 other therapeutic areas. Hospitals
and healthcare care professionals are able to take advantage of ForTec’s pay-per
-use model to gain real-time access to groundbreaking technologies and premier
service, without having to conduct an extensive capital budgeting evaluation,”
said Patrick Filipovitz, CEO of ForTec. “With our mobile SaphiraT tower
solution, we aim to expand the use of blue light cystoscopy by reducing the
barriers for healthcare institutions to gain access to this cutting-edge
equipment. In coordination with Karl Storz and Photocure, our highly trained
sales professionals and technicians will support cases and ensure safe and
proper operation of the equipment.”

*TURBT: Transurethral resection of bladder tumor

Note to editors:

BLC, Hexvix and Cysview, trademarks mentioned in this release, are protected by
law and are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.

About Bladder Cancer

Bladder cancer ranks as the 8[th] most common cancer worldwide - the 5[th] most
common in men - with 1 949 000 prevalent cases (5-year prevalence rate)[1a], 614
000 new cases and more than 220 000 deaths in 2022.[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 [February 2024].
[2 ]Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
[3 ]Sievert KD et al. World J Urol 2009;27:295-300
[4 ]Bladder Cancer. American Cancer Society.
https://www.cancer.org/cancer/bladder-cancer.html

About Hexvix[®]/Cysview[®] (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the
bladder, making them glow bright pink during Blue Light Cystoscopy (BLC[®]). BLC
with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves
the detection of tumors and leads to more complete resection, fewer residual
tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all
other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S.
and Europe and has strategic partnerships for the commercialization of
Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer
to Our partners for further information on our
commercial partners.

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com

About KSEA

KARL STORZ Endoscopy America Inc. (KSEA) is a subsidiary of KARL STORZ
headquartered in Tuttlingen Germany. a global manufacturer and distributor of
endoscopes, medical instruments, and devices. Since its establishment, KARL
STORZ Endoscopy-America has been responsible for all sales of endoscopes,
instruments, imaging systems, electromechanical devices, and OR1T integration
solutions for the operating room. Based in El Segundo, California, this
subsidiary maintains a reliable network, with employees ensuring customer care,
product consultation, and sales in all US states.

About ForTec

ForTec Medical, an industry leader, is dedicated to improving patient health and
healthcare by delivering innovative surgical technologies on demand. For more
than 30 years, ForTec has provided mobile surgical technologists to hospitals,
surgery centers and physician offices on an as-needed basis.

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

Kilde

[Southpassage]

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.

[TekBot]

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

Oslo, Norway, July 15, 2024: Photocure ASA (OSE: PHO), the Bladder Cancer
Company, today announces that it has entered into a strategic agreement with
Richard Wolf GmbH to develop and commercialize a next-generation 4K LED high
…

Vis børsmeldingen

-definition (HD) reusable flexible blue light cystoscope based on Richard Wolf’s
System blue technology. The partnership between Photocure and Richard Wolf is
focused on developing technologically advanced flexible blue light cystoscopy
(BLC[®]) equipment for the global market so that physicians who treat patients
with bladder cancer can offer the benefits of BLC with Hexvix[®] / Cysview[®] in
an outpatient, or surveillance setting.

Under the Agreement, Richard Wolf will develop the new flexible BLC system with
input and guidance from Photocure, tapping into Photocure’s extensive knowledge
of the surveillance procedure and the Company’s experience with urology
customers. The new flexible blue light system and underlying intellectual
property will be owned by Richard Wolf, who will also serve as the sponsor of
market authorizations around the world. Photocure and Richard Wolf will share
expenses for the development and regulatory activities necessary for approvals
of the HD flexible blue light system in markets where it will be commercialized.

The strategic partnership between Photocure and Richard Wolf builds off a
longstanding relationship between the two companies associated with co
-promotion, disease awareness, education, market development, and clinical
research. Photocure and Richard Wolf will co-promote the new blue light flexible
system in the U.S., Europe and other countries globally.

Photocure will leverage its existing sales organization to promote the new
reusable flex system in North America and Europe, and will rely on Richard Wolf
distributors or commercial partners to co-promote the device in other markets.
Additionally, Photocure will utilize data from existing patient registries to
leverage real-world evidence to further support the benefits of flexible blue
light cystoscopy for patients with non-muscle invasive bladder cancer. Per the
agreement, Photocure and Richard Wolf will establish two governance committees
to oversee progress of the collaboration including a Joint Development Committee
to ensure R&D milestones are successfully achieved and a Joint Commercialization
Committee to execute pre- and post-approval go-to-market strategies globally.

New flexible BLC equipment has not been available for purchase since early 2023
in the U.S., as prior systems were outdated and discontinued by the
manufacturer. As a leading company focused on the management of bladder cancer,
Photocure is dedicated to ensuring that BLC with Hexvix/Cysview is available to
physicians worldwide in both the surgical and surveillance settings so that
patients with bladder cancer can have access to the best care.

“Entering into this partnership with Richard Wolf is a milestone for Photocure,
and more importantly is the first step toward making high-definition BLC
equipment in the surveillance setting consistently available for patients
globally,” said Dan Schneider, President and CEO of Photocure. “Before the phase
-down of standard-definition flexible blue light equipment in the U.S., adoption
of these systems was on a strong growth path with physicians recognizing the
significant benefits of precision monitoring of bladder tumors with BLC and
Cysview. We look forward to working with Richard Wolf on the development and
anticipated commercialization of a 4K high-definition blue light cystoscope, and
bringing a cutting edge and cost-effective solution to physicians and patients
in our commercial territories as soon as possible.”

“As a full-service provider in endoscopy and a leading manufacturer of blue
light cystoscopy equipment, we are very pleased to enter into this Agreement
with Photocure, to develop and commercialize a first-in-class/best-in-class high
-definition flexible blue light system,” said Florian Happe, Vice President R&D
at Richard Wolf. “The workmanship that goes into every Richard Wolf device
provides the foundation for exceptional precision and longevity in the clinical
setting, enabling our institutional and physician customers to deliver
excellence in care to their patients. Surveillance of patients with bladder
cancer is of critical importance in disease management, and we believe that a
high-definition blue light cystoscope designed for out-patient use has potential
to set a new standard in this care setting.”

Note to editors:

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.

This press release may contain product details and information which are not
valid, or a product is not accessible, in your country. Please be aware that
Photocure does not take any responsibility for accessing such information which
may not comply with any legal process, regulation, registration or usage in the
country of your origin.

About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide - the 5th most
common in men - with 1949 000 prevalent cases (5-year prevalence rate)1a, 614000
new cases and more than 220000 deaths in 2022.1b
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 [February 2024].

2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657

3 Sievert KD et al. World J Urol 2009;27:295-300

4 Bladder Cancer. American Cancer Society. https://www.cancer.org/cancer/bladder
-cancer.html

About Hexvix®/Cysview® (hexaminolevulinate HCl)
Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the
bladder, making them glow bright pink during Blue Light Cystoscopy (BLC®). BLC
with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves
the detection of tumors and leads to more complete resection, fewer residual
tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all
other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S.
and Europe and has strategic partnerships for the commercialization of
Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer
to Our partners for further information on our
commercial partners.

About Photocure ASA
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.hexvix.com, www.cysview.com

About Richard Wolf
Richard Wolf GmbH is a medium-sized medical technology company with over 1,800
employees, along with eighteen subsidiaries and 130 foreign agencies worldwide.
The company develops, produces, and distributes numerous products for endoscopy
and extracorporeal shock wave treatment in human medicine. Integrated operating
room systems round out the product range.

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Email: ds@photocure.com

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: ed@photocure.com

David Moskowitz
Vice President, Investor Relations
Photocure ASA
Tel: +1 202 280 0888
Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

Kilde

[Southpassage]

Noen som har en god forklaring på hvorfor den falt så mye på børsmeldingen?

[Bingo123]

Du kan lese innleggene i småprat tråden pg danne deg et inntrykk/bilde selv

[kreinh]

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

[TekBot]

Photocure ASA: Invitation to presentation of second quarter and first half year 2024 financial results

Oslo, Norway, 31 July 2024: Photocure ASA (Photocure, PHO: OSE) will announce
the second quarter and first half year 2024 financial results on Wednesday 7
August 2024 at 08:00 CEST and will present a live webcast at 14:00 CEST the same
…

Vis børsmeldingen

day.

The quarterly report and presentation will be published at 08:00 CEST and will
be publicly available at www.photocure.com.

The investor presentation will be streamed live and be hosted by Dan Schneider,
CEO and Erik Dahl, CFO. The presentation will be held in English and questions
can be submitted throughout the event. The presentation is scheduled to conclude
at 14:45 CEST.

The streaming event is available through

https://channel.royalcast.com/landingpage/hegnarmedia/20240807_1/

For further information, please contact:

Photocure
Erik Dahl
CFO
Tel: +47 45055000
Email: ed@photocure.com

Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway) Tel: +47 91540000
Email: geir.bjorlo@corpcom.no

About Photocure
Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.cysview.com

This information is subject to the disclosure requirements pursuant to section 5
-12 of the Norwegian Securities Trading Act

Kilde

[TekBot]

Photocure ASA: Results for the second quarter of 2024

Oslo, Norway, 7 August 2024 - Photocure ASA (OSE:PHO), The Bladder Cancer
Company, today reported Hexvix®/Cysview® revenues of NOK 122.4 million in the
second quarter of 2024 (Q2 2023: NOK 115.9 million) and EBITDA of NOK 27.8
…

Vis børsmeldingen

million (NOK 23.4 million). Photocure reiterates its 2024 financial guidance of
product revenue growth of 6% to 9% in constant currency and positive EBITDA
excluding business development expenses. Photocure now expects new and upgraded
SaphiraT installations in the U.S. in the range of 55 to 70 towers for the full
year, up from the previous range of 40 to 70 towers.

“Photocure had a productive second quarter as we delivered Hexvix/Cysview
revenue growth of 6% year-over-year and EBITDA of NOK 27.8 million. Year-to
-date, we have reported 8% revenue growth, on track with our top-line guidance
for the year. Once again, both our North American and European business segments
had positive contributions during the period as we continue to grow revenues and
contain our expenses. We also initiated key business development activities to
accelerate our growth in the coming quarters and years,” says Dan Schneider,
President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 145.4 million in the second
quarter of 2024 (NOK 144.3 million), and EBITDA* of NOK 27.8 million (NOK 23.4
million), driven by revenue growth and a milestone payment from Asieris for the
NDA acceptance of Cevira® in China. Hexvix/Cysview revenues were NOK 122.4
million in the quarter (Q2 2023: NOK 115.9 million). The EBIT was NOK 20.7
million (NOK 16.8 million) and the cash balance at the end of the period was NOK
267.0 million.

“During the second quarter, 20 new Saphira towers were installed including 5 new
account placements, 3 accounts that upgraded to Saphira, and 12 mobile BLC
towers delivered to ForTec Medical. High-definition Saphira systems now
represent approximately 46% of the installed base of rigid BLC towers in the
U.S. In early June, we announced our mobile tower initiative in the U.S. market,
aligned with an agreement between ForTec and Karl Storz to provide on-demand
Saphira BLC equipment to ForTec’s vast network of hospital customers. ForTec is
in the process of rolling out the program nationally, and we look forward to
working with them to expand access to BLC procedures in the U.S.,” Schneider
adds.

At the end of the second quarter of 2024, the installed base of rigid BLC
systems in the U.S. was 381, up 17% from the same period in 2023. This includes
18 mobile towers owned by ForTec Medical. In the U.S. 25 flexible BLC towers
remain active. After the closing of the quarter, Photocure entered into an
agreement with Richard Wolf to develop and globally commercialize a high
-definition blue light flexible cystoscope.

“Turning to potential drivers of our long-term growth, we were very pleased to
announce our partnership with Richard Wolf to develop and commercialize a state
of the art high-definition flexible blue light system. Richard Wolf is a premier
manufacturer of endoscopy equipment, and our partnership is focused on ensuring
that physicians and patients have reliable access to state-of-the-art, high
quality BLC in the surveillance setting. Given the number of new non-muscle
invasive bladder cancer therapeutics that have, or are expected to enter the
market, we believe that BLC technology will be more important than ever to
properly identify, stage and manage bladder cancer patients. As we head into the
second half of this year, we remain focused on accelerating the growth of our
Hexvix/Cysview franchise, leveraging our established commercial infrastructure,
and executing on the many initiatives and activities that can take Photocure to
the next level,” Schneider concludes.

Photocure believes that the benefits of Blue Light Cystoscopy with
Hexvix®/Cysview® offering superior detection and management of bladder cancer
will continue to be adopted and become the standard of care. The Company
reiterates its 2024 financial guidance and continues to expect consolidated
product revenue growth of 6% to 9% in constant currency and positive EBITDA
excluding business development expenses. Photocure now expects new and upgraded
SaphiraT installations in the U.S. in the range of 55 to 70 towers, up from the
previous range of 40 to 70 towers for the full year.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and
reconciled to the IFRS financial statements as a part of the APM section of the
second quarter 2024 financial report on page 25.

The quarterly report and presentation will be published at 08:00 CEST and will
be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl,
CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted
throughout the event. The streaming event is available through
https://channel.royalcast.com/landingpage/hegnarmedia/20240807_1/

The presentation is scheduled to conclude at 14:45 CEST.

For further information, please contact:

Dan Schneider

President and CEO

Photocure ASA

Email: ds@photocure.com

Erik Dahl

Chief Financial Officer

Tel: +47 450 55 000

Email: ed@photocure.no

David Moskowitz

Vice President of Investor Relations

Tel: +1 202 280 0888

Email: david.moskowitz@photocure.com

Media and IR enquiries:

Geir Bjørlo

Corporate Communications (Norway)
Tel: +47 91540000

Email: geir.bjorlo@corpcom.no

About Photocure ASA

Photocure: The Bladder Cancer Company delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, making
cancer cells glow bright pink, has led to better health outcomes for patients
worldwide. Photocure is headquartered in Oslo, Norway and listed on the Oslo
Stock Exchange (OSE: PHO). For more information, please visit us at
www.photocure.com, www.cysview.com

All trademarks mentioned in this release are protected by law and are registered
trademarks of Photocure ASA.

This information is considered to be inside information pursuant to the EU
Market Abuse Regulation and is subject to the disclosure requirements pursuant
to section 5-12 of the Norwegian Securities Trading Act. This stock exchange
announcement was published by Tolv Hillestad, Group Controller, Photocure ASA,
on 7 August 2024 at 08:00 CEST.

Kilde

[Do2Do]

Photocure_Q2_2024_transcript – Kopi.pdf (136,6 KB)

[Jubel]

Asieris Pharmaceuticals Releases 2024 Semi-Annual Report, Highlighting Steady...

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.”

[Jubel]

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

[Entrere]

Dette er positive nyheter

[kreinh]

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

[Merlin]

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%.

[Merlin]

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.

[Jubel]

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