Photocure fundamentale forhold (PHO)

TekBot · oktober 16, 2020, 5:32am

New data analysis on Blue Light Cystoscopy efficiency presented at the virtual BLADDR 2020 congress

PRESS RELEASE - Oslo, Norway, 16 October, 2020: Photocure ASA (OSE:PHO) today
announces a highlight from the BLADDR 2020 congress, a poster presentation on
new findings from the Nordic Flexible BLC registry, an ongoing prospective
…

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multicenter study. It demonstrates that flexible Blue Light Cystoscopy helped
resolve a substantial amount of cases by complete removal on-site or direct
referral to intravesical treatment, providing increased efficacy to manage non
-muscle-invasive bladder cancer (NMIBC) in the office setting.

The BLADDR congress, held virtually this year, is solely focused on bladder
cancer and attracts the interest of experts from all over the world.

“It is encouraging to see how data on the blue light cystoscopy procedure
continues to provide new insight into the efficiency of how to manage NMIBC in
the office setting. The BLC procedure is a tool that helps physicians solve such
cases outside of the OR. Using blue light cystoscopy with Hexvix, they trust
their detection capabilities in the office and can treat the lesions
immediately, perform confirmatory biopsies or initiate intravesical therapy.
Such options are less costly than OR procedures, thus helping to keep costs down
for the healthcare system and sparing the patient additional surgical procedures
in the OR. This is a clear win-win situation for both patient and healthcare
system”, says Dan Schneider, President and CEO of Photocure.

Methodology and data from the study:

The Nordic Flexible BLC registry is an ongoing prospective multicenter study
initiated to observe the clinical use and explore possible benefits of blue
light cystoscopy in the surveillance setting. From five participating sites, 354
patients in follow-up of NMIBC have been included in the study. Data from 462
blue light procedures were included.

In follow-up of NMIBC, in a predominant intermediate and high-risk patient
population, this analysis shows how blue light cystoscopy in a surveillance
setting helped resolve a substantial amount of cases by complete removal of
lesions on-site, or direct referral to intravesical instillation. In 88% of
cases where suspicious lesions were seen, no further diagnostic or surgical
treatment procedures (TURBT) were needed.

The authors conclude that blue light cystoscopy in the surveillance setting
provides increased efficiency to manage NMIBC.

Here is a link (https://www.morressier.com/article/flexible-blue-light
-cystoscopy-provides-increased-efficacy-manage-nonmuscle-invasive-bladder-cancer
-outpatient-clinic/5f4d121e6d2dd7debfa950ae?) to the poster.

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 sixth most common cancer worldwide with 1 650 000
prevalent cases (5-year prevalence rate), 550 000 new cases and almost 200 000
deaths annually in 2018.[1]

Approx. 75% of all bladder cancer cases occur in men.[1] It has a high
recurrence rate with an average of 61% in year one and 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. Incidence/mortality by
population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
[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[TM]). BLCT with Hexvix[®] /Cysview[® ]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 the Nordic region and has strategic partnerships for
the commercialization of Hexvix[®]/Cysview[®] in Europe, Canada, Australia and
New Zealand. Please refer to https://bit.ly/2wzqSQQ 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

For further information, please contact:

Photocure

Dan Schneider
President and CEO
Tel: +1-609 759-6515
Email: ds@photocure.com

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

Kilde

deepmind · oktober 16, 2020, 5:59am

https://www.morressier.com/article/flexible-blue-light-cystoscopy-provides-increased-efficacy-manage-nonmuscle-invasive-bladder-cancer-outpatient-clinic/5f4d121e6d2dd7debfa950ae?

Legger inn hyperlenken som ikke funket i posten ovenfor

Rodjer · oktober 16, 2020, 7:12am

ufo · oktober 16, 2020, 10:02am

Endrer denne nye meldingen i dag noe på den mulige konkuransen fra NBI i PHO sitt favør?

Savepig · oktober 19, 2020, 9:24am

ABG øker kursmål i Photocure til 130 fra 125

Photocure - Q3: a solid stepping stone towards expansion

Q3 results due 10 November US recovery and EU commercialisation in the spotlight Tweaking near term ests. – DCF TP up to NOK 130 (125)

Tekspert · november 1, 2020, 10:00am

Hver måned kårer jeg det jeg kaller Teksperter™ for noen av de mest populære investeringene våre

Det er de 3 medlemmene som har fått flest likes på innleggene sine de siste 90 dagene. Teksperter™ får også en unikt merke på profilen sin og et trofé-ikon ved siden av navnet sitt. Du kan bli Tekspert™ i flere aksjer/investeringer, og troféet vil bare vises i tråder der du er Tekspert™.

Her er denne månedens Teksperter™ og det mest likte innlegget deres fra de siste 90 dagene:

@Rodjer (520 likes)

@Savepig (128 likes)

@solskimm (113 likes)

Resten av topp 10:

@rosk82 (43 likes)
@Snoeffelen (29 likes)
@Fso (29 likes)
@JTHP (21 likes)
@Ebitor (19 likes)
@FiloD (19 likes)
@myk (19 likes)

Gratulerer!

Duogdu · november 2, 2020, 8:05am

TekBot · november 4, 2020, 12:53pm

Photocure ASA: Invitation to presentation of third quarter 2020 financial results

Oslo, Norway, 4 November 2020: Photocure ASA (Photocure, PHO: OSE) will announce
the third quarter 2020 financial results on Tuesday 10 November 2020 at 07:00
CET and invites investors, analysts and the media to a presentation at 14:00 CET
…

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the same day.

The investor presentation will be streamed live and be hosted by Daniel
Schneider, CEO and Erik Dahl, CFO. The presentation will be held in English and
questions can be submitted throughout the event.
The quarterly report and presentation will be published at 07:00 CET and will be
publicly available at www.photocure.com. The streaming event is available
through https://channel.royalcast.com/hegnarmedia/#!/hegnarmedia/20201110_3

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

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.hexvix.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 · november 10, 2020, 6:01am

Photocure ASA: Results for the third quarter of 2020

Oslo, Norway, 10 November 2020: Photocure ASA (OSE:PHO) today reported
Hexvix[®]/Cysview[®] revenues of NOK 49.6 million in the third quarter of 2020
(Q3 2019: NOK 51.1), with the U.S. market continuing the Covid-19 rebound with a
…

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growth of 20%. Photocure has successfully launched the European Hexvix
operations and reiterates the strong outlook and 2023 ambitions.

President & CEO Daniel Schneider comments: "The important U.S. market continued
to rebound in the third quarter with a 17% increase in YOY unit sales as fewer
procedures were postponed and business disruptions eased. We have deliberately
maintained our full commercial capabilities throughout the uncertainty of the
COVID pandemic in order to maximize the agility and flexibility necessary to
engage our customers personally, virtually and digitally. Photocure expects
continued changes in business conditions, but we are well positioned to
capitalize on opportunities through various methods. For this reason, we are
confident that we will weather the disruptions well and business will return to
the pre-COIVD-19 strong growth rates once the pandemic resolves.

We also concluded a successful transition of Ipsen’s European operations to
Photocure and launched our European commercial operations on October 1. We have
invested in our European commercial organization, establishing an efficient
distribution and third-party logistics network throughout Europe. The entire
European team has worked tirelessly to ensure we hit the ground running, and I
am very pleased with the seamless transition. We are deploying our full
commercial capabilities to grow and expand these new markets".

Photocure reported total group revenues of NOK 49.9 million in the third quarter
of 2020 (NOK 60.8 million), with an EBITDA before restructuring of NOK -5.4
million (NOK 8.3 million). The Hexvix/Cysview revenues were NOK 49.6 million
(NOK 51.1 million). The demand in the U.S. market continued to rebound during
the quarter, with the in-market unit sales up 17 per cent, while the Ipsen
transition contributed to a one-off revenue reduction of NOK 8.9 million in the
European market and had a negative EBITDA impact of approximately NOK 7 million.

The installed base of rigid cystoscopes in the U.S. was 253 at the end of the
third quarter, an increase of 42 units or 20% since the same quarter last year.
Blue Light Cystoscopy (BLC[®]) in the surveillance setting is a key priority for
Photocure in the U.S. market. By the end of the 3rd quarter, a total base of 33
flexible cystoscopes have been installed giving more patients access to the
procedure with less constraints.

“We experience a solid underlying development across markets. In Europe, the
preparations for the commercial Hexvix operations had a one-off impact on the
revenues in the third quarter and the growth will be evident from the last
quarter of the year, while the sales development in the U.S. continues to
accelerate. By maintaining our commercial resources during the Covid-19 pandemic
we can ensure a rapid recovery as the situation improves,” Schneider adds.

Over the past six months, Photocure has built the commercial infrastructure to
launch direct to market operations for Hexvix in the European markets formerly
operated by Ipsen. The successful transition and launch of European Hexvix
operations on October 1[st] has created a robust platform for accelerated growth
and expansion for Photocure.

The Hexvix rights were transferred to Photocure with the official launch of the
commercial operations beginning 1 October 2020. Photocure has paid Ipsen EUR 15
million for regaining the Hexvix rights and Ipsen will also receive earn-out
payments in the range of 10 -15% of sales (years 1-7 post-transfer) and 7.5% of
sales (years 8-10) in the former Ipsen markets.

“The U.S. and Europe are Photocure’s main growth markets, with large untapped
opportunities, and the Ipsen agreement is expected to be EBITDA accretive from
the full-year 2021 and beyond. Based on the outlook and strategic opportunities,
Photocure maintains its group revenue ambitions for 2023 in the range of NOK 1
billion, with EBITDA margins of approximately 40%,” Schneider concludes.

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
third quarter 2020 financial report on page 22-23.

Photocure will present its third quarter 2020 report on Tuesday 9 November 2020
at 14:00 CET. The investor presentation will be streamed live and be hosted by
Daniel Schneider, CEO and Erik Dahl, CFO.

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/hegnarmedia/#!/hegnarmedia/20201110_3. The
presentation is scheduled to conclude at 14:45 CET.

For further information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: ds@photocure.com

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: ed@photocure.no

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.hexvix.com, www.cysview.com

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

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

Kilde

Savepig · november 10, 2020, 11:39am

ABG ute med oppdatert analyse ser jeg

Noen som vet prismål?

Rodjer · november 10, 2020, 11:44am

Delte den i fb gruppen også i håp om at noen har tilgang, men utfra det vi kan lese er nok ikke kursmålet senket hvertfall.

solskimm · november 11, 2020, 4:23pm

Første pasient i Cevira!

Ikke nok med det, Asieris har hentet cash for å finansiere gildet!

TekBot · november 11, 2020, 5:12pm

Asieris Announces First Patient Administration in the Global Phase III Clinical Trial for APL-1702 (Cevira)

Oslo, Norway, 11 November, 2020: Photocure ASA (OSE:PHO) today announces that
its partner Asieris Pharmaceuticals has initiated the phase III clinical trial
for APL-1702 (Cevira[®]), triggering a USD 1.5 million milestone payment under
…

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the global licensing deal.

“The initiation of the phase III clinical trial for Cevira is an important
milestone towards a non-surgical treatment of high-grade cervical dysplasia. Our
partner Asieris is making great progress and is on track with their clinical
program and development of this innovative photodynamic drug-device
combination,” says Daniel Schneider, Chief Executive Officer of Photocure.

Asieris, a China-based biotech company with global aspirations to discover,
develop, and commercialize innovative drugs for the treatment of genitourinary
tumors and related diseases, has initiated its multi-centered, phase III
clinical trial of its photodynamic drug-device combination product, APL-1702
(Cevira[®]), which is being developed for the non-surgical treatment of high
-grade squamous intraepithelial lesions (HSIL).

The first patient was enrolled and administered in this trial, which will be
used for global registration of Cevira. HSIL is a pre-cancerous condition caused
by a persistent HPV infection. Each year there are approximately 10 million
cases of high-grade disease and over 500,000 new cases of cervical cancer
worldwide. In China, approximately 2% of women develop HSIL each year.

Dosing of the first patient in this trial triggers a USD 1.5 million milestone
payment from Asieris to Photocure, as part of the global licensing deal with a
potential of up to USD 250 million in milestones and double-digit royalties. The
milestone has been recognized as 2019 revenues following IFRS standards, with
cash payment to be received in the fourth quarter of 2020.

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 Cevira
Cevira[®] is a photodynamic drug-device combination product that is being
developed for non-surgical treatment of high-grade cervical dysplasia. Cevira is
easily placed on the cervix by the gynecologist and removed by the patient, with
no disruption of normal daily activities. Only one or two treatments are needed.

About Cervical dysplasia
High grade cervical squamous intraepithelial lesions (HSIL) is a precancerous
condition caused by a persistent HPV infection, a highly prevalent sexually
transmitted disease resulting in approximately 10 million cases with high grade
disease and > 500 000 new cases of cervical cancer each year. In China,
approximately 2% of women have HSIL each year. Currently, surgical excision is
the most common treatment option offered to women with cervical high-grade
dysplasia. In women of childbearing age in particular there is a high medical
need for a non-surgical option which preserves the cervical anatomy and
function. No such medical alternative is approved to date.

About Photocure ASA
Photocure, The Bladder Cancer Company, delivers transformative solutions to
improve the lives of bladder cancer patients. Our unique technology, which makes
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 or www.cysview.com

For further information, please contact:

Photocure

Dan Schneider
President and CEO
Tel: +1-609 759-6515
Email: ds@photocure.com

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

Kilde

Savepig · november 12, 2020, 10:32am

Går på skinner det her

Her er de opprinnelige slidesene fra August og November i fjor, da var det 2024 som var guidet for første indikasjonen:

15-33 måneder var anslått tidsrom for å få første pasient dosert. Fasiten ble vel da sånn ca 15?

Savepig · november 16, 2020, 8:39am

Avanza opp på topp 10

Cheerup · november 16, 2020, 8:46am

Er det småsparere aka Nordnet i Sverige eller hvem er det?

Savepig · november 16, 2020, 8:49am

Jepp, Avanza er vel Nordnet sin største konkurrent på retail i sverige?

De har også en konkurrent til Shareville:

TekBot · november 30, 2020, 1:37pm

Photocure ASA: Exercise of employee share options and share capital increase

Oslo, Norway, 30 November 2020: Participants in Photocure ASA’s (“Photocure” or
the “Company”) share option program have on 30 November 2020 exercised a total
of 90,150 options distributed as follows:
…

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· 81,700 options exercised according to the option program for 2016 at a strike
price of NOK 40.15;
· 700 options exercised according to the option program for 2017 at a strike
price of NOK 38.06; and
· 7,750 options exercised according to the option program for 2019 at a strike
price of NOK 50.72.

Each option gives a right to receive one share in the Company. The share options
are described in note 7 and 23 in Photocure’s annual financial statements for
2019.

Following the exercise, the Board of Directors, pursuant to authorisation
granted by the Company’s Annual General Meeting, has decided to increase the
Company’s share capital by NOK 45,075 by issuing 90,150 new shares, of par value
NOK 0.50. Subsequent to the transaction, Photocure’s share capital will be NOK
13,358,768 divided into 26,717,536 shares, each share having a par value of NOK
0.50 and carrying one vote in the Company’s general meeting.

Primary insiders of the Company have exercised options that would otherwise have
expired on 31 December 2020 at a strike price of NOK 40.15. The following
options are exercised by primary insiders:

· Erik Dahl, CFO, has exercised 25,500 options.
· Grete Hogstad, VP Strategic Marketing, has exercised 21,000 options.
· Gry Stensrud, VP Technical Development and Operation, has exercised 26,300
options.

The primary insiders mentioned above have transferred their rights to receive
shares resulting from the exercise of options to a third party. Following a sale
of shares, the primary insiders will receive the net proceeds after deduction of
the strike price and accrued tax. The primary insiders will use the full net
proceeds to purchase shares in Photocure. The sales amount and the number of
shares purchased will be finally determined on the basis of the price
subsequently obtained by the third party in the market. The results of the sales
process and final number of new shares for primary insiders, as well as their
updated shareholdings, will be announced in a separate stock exchange notice
when known.

For further information, please contact:

Photocure CFO Erik Dahl
Tel: +47 450 55 000
Email: ed@photocure.com

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

This information is subject to the disclosure requirements pursuant to sections
5-12 and 4-2 of the Norwegian Securities Trading Act.

Kilde

myk · november 30, 2020, 1:46pm

Er det dette som tynger aksjen i dag. ?

Savepig · november 30, 2020, 2:08pm

Innsidekjøp burde jo strengt tatt ikke tynge, men volumet er vel så lavt at til og med dettte lille salget kan presse litt ned?

Hva er det som gjør at det er mer skattemessig gunstig å gjør det på denne måten?