Photocure fundamentale forhold (PHO)

Astrup · november 5, 2019, 7:55pm

Ja, du har rett, tiden går så alt for fort. Jeg tok et utgangspunkt tidligere i sommer

InVivo · november 6, 2019, 4:25pm

Er ikke dette en sinnsykt bra melding? Eller har jeg misforstått?

roblar · november 6, 2019, 4:29pm

Saken ble diskutert litt lenger oppe i tråden og på PHO småprat. Det er snakk om noen typer behandlinger som får litt økt støtte. Ikke noen voldsomt stor nyhet, men alt av støtte er positivt

Londonmannen · november 6, 2019, 4:46pm

Det er ikke «den litt økt støtte» som betyr noe ibdenne meldingen. Refusjonen betyr ikke noe for hva PHO får for en dose Cysview. Men denne beslutningen sender et sterkt signal om at det skal benyttes BLC til behandling. Noe som vil bidravtil at terskelen for å beslutte anskaffelse av flexiscope blir langt lavere. Det er i en slik kontekst man må lese meldingen. De ekstra dollarene som klinikkene får i refusjon vil komme PHO til gode indirekte gjennom flere flexiscope blir raskere utplassert og derigjenom gir et høyere forbruk av Cysview.

I realiteten en fantastisk melding for PHO og selskapets aksjonærer.

Wannatri · november 6, 2019, 4:57pm

De har ikke fått code A; skal brukes, om det er det du tenker på.

Jeg oppfattet det slik da jeg skummet meldingen første gang.
Men, DET ville vært en killermelding…

TekBot · november 7, 2019, 9:25pm

Photocure ASA: Results for the third quarter of 2019

Tråd om Q3:

Oslo, Norway, 7 November 2019: Photocure ASA (OSE:PHO), today reported a revenue
growth of 42% in local currency for the U.S. market in the third quarter of
2019, contributing to Hexvix/Cysview revenues of NOK 51.1 million (Q3 2018: NOK
…

Vis børsmeldingen

43.5) and an EBITDA of NOK 8.3 million (NOK -3.1 million). The company entered
into a license agreement with Asieris for the global commercialization of
Cevira® and reiterates the significant revenue growth and profit opportunities
in the U.S. market.

“The third quarter was a busy period for Photocure with continued strong growth
in the important U.S market and an increase in the installed base of blue light
cystoscopes to 211 at the end of the quarter. This development provides a solid
platform for further growth in 2020 and beyond, as we see a large untapped
potential in the U.S. We will continue to develop the significant commercial
opportunities in the U.S. in order to achieve our ambition to make Cysview the
standard of care for bladder cancer patients,” says Daniel Schneider, President
& Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 60.8 million in the third quarter
of 2019 (NOK 44.4 million), with an EBITDA of NOK 8.3 million (NOK -3.1
million). Net result was NOK -0.6 million (NOK -4.8 million), while the cash
position ended at NOK 95.9 million. The sales development in the U.S. was strong
with an accelerated unit sales increase of 34% in the quarter. The revenues in
the Nordics declined 7% to NOK 9.9 million (NOK 10.6 million) in the third
quarter. EBITDA for the Hexvix/Cysview commercial franchise ended at NOK 2.6
million in the third quarter of 2019. At the end of the period, the total
installed base of permanent blue light cystoscopes (BLCs) in was 189 the U.S. In
addition, 22 flexible cystoscopes for the surveillance setting have been
installed, which represents an increase of 8 in the quarter.

Photocure has built considerable experience in the bladder cancer market through
its Hexvix/Cysview franchise and sees significant long-term value creation
potential in this market segment. The company aims to capitalize on a number of
factors including inclusion in the AUA-SUO guidelines, increased patient
awareness and the improved reimbursement of Cysview from 2020. These drivers
will significantly increase penetration in the U.S. market. Furthermore, with
the approval of Cysview to be used with flexible cystoscopes, a significant
market opportunity has opened in the surveillance segment.

Given the large untapped market opportunities, the company has invested in the
U.S. commercial and medical infrastructure. October 1, Geoffrey Coy joined
Photocure as Vice President and General Manager of U.S. operations to strengthen
the growth initiatives further. The company has a 2020 forecasted revenue range
of USD 20-25 million in the U.S., up from USD 7.8 million in 2018, and sees
significant continued revenue growth and profit opportunities in the U.S. market
beyond 2020. The company is fully funded for this strategy.

During the third quarter, Photocure entered into a license agreement providing
Asieris Meditech Co., Ltd (Asieris) with a world-wide license to develop and
commercialize Cevira® for the treatment of HPV induced cervical precancerous
lesions.

Asieris plans to launch a global clinical development program with an initial
focus on the China market based on Photocure’s Phase 2b data and the Phase 3
study design elements agreed with the U.S. FDA. The development for the US and
EU markets will follow when clinical data from the China focused Phase 3 study
confirms the safety and efficacy, estimated to be finished in 2022. Asieris will
assume responsibility for the manufacture of the Cevira® product while Photocure
retains responsibility for the manufacture of the active pharmaceutical
ingredient. Under the License Agreement, Photocure will receive a total signing
fee of USD 5 million within 6 months after signing. In addition, the company may
receive a total of USD 18 million based upon achievement of certain clinical and
regulatory milestones in China and up to USD 36 million for certain clinical and
regulatory milestones in USA and EU. Approval of a second indication in China,
the US and the EU would result in payments of up to USD 14 million.
Additionally, sales milestones and royalties of 10% to 20% will apply in all
markets.

“We were proud to announce the agreement with Asieris during the quarter. Aseris
will have the world-wide license to develop and commercialize Cevira for the
treatment of HPV induced cervical precancerous lesions. Under the agreement,
Photocure will receive signing fees, and potentially development and approval
milestones and sales milestones in total up to USD 250 million, in addition to
sales royalties. The Cevira deal is in line with our strategy of divest and
maximize the value of products that do not fit our strategic focus, and to build
the Bladder Cancer Company,” Schneider concludes.

Please find the full financial report and presentation enclosed.

Photocure will present its third quarter report on Thursday 7 November 2019 at
Hotel Continental, Oslo, Norway. The presentation will begin at 08:30 (CET) and
representatives from the company will be Daniel Schneider, President & CEO and
Erik Dahl, CFO. The presentation will be held in English.

It will be possible to follow the presentation through
https://webtv.hegnar.no/presentation.php?webcastId=9816440

A light snack will be served from 08:00 (CET). The presentation is scheduled to
conclude at 09:15 (CET).

For further information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: [email protected]

Erik Dahl
Chief Financial Officer
Tel: +47 450 55 000
Email: [email protected]

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). The US headquarters for Photocure Inc., are in
Princeton, New Jersey. For more information, please visit us at
www.photocure.com, www.hexvix.com or www.cysview.com

Kilde

Savepig · november 7, 2019, 9:24pm

Denne har jeg ikke sett før:

Savepig · november 8, 2019, 12:12pm

Hkirk · november 8, 2019, 12:43pm

Fra morgenrapporten til Richard Paulsen fredag:

-/ ALLE SELSKAPER server et optimistisk budskap når det legger frem kvartalstall. Kommuniser minusene, men fokuser på plussene. Photocure rapporten derimot, virker dog gjennomgåe positiv. De har god vekst i USA, og vurderer testing av Hexvix for bredere terapautisk behandling. Det kan åpne opp en helt nye pengestrøm for et selskap som har snudd tap til gevinst på eksisterende virksomhet det siste året. Inntekter, økende salg, nye satsninger. Er det ikke det slike selskaper man bør investere i… Jeg har skrevet om aksjen fra 40 tallet, og nå handler den på 57 kroner, svært nærme rekordnoteringen på 62 kroner. Hvorfor skal ikke Photocure bryte opp hvis virksomheter vokser?

Savepig · november 9, 2019, 1:02pm

Vi ser nå en klar hockey stick tendens i utplasserte skop, etter at Q3 tallene plutselig var ATH i antall utplasserte skop, i det historisk sett svakeste kvartalet:

TekBot · november 18, 2019, 7:00am

Photocure: First trial demonstrating reduced recurrence after flexible Blue Light Cystoscopy with Hexvix[®] in surveillance

Use of flexible Blue Light Cystoscopy at the first follow-up after TURBT*
reduced the risk of tumor recurrence by 33% compared to white light alone.
Randomized controlled multi-center study with 699 bladder cancer patients
…

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presented at Danish Urological Society meeting.

Oslo, Norway November 18, 2019, Photocure ASA (PHO:OSE), is pleased to announce
that results from new studies with flexible Blue Light Cystoscopy (BLCT) with
Hexvix were presented at the annual meeting of the Danish Urology Society on
Saturday, November 16.

Results from a randomized controlled study in 699 patients from three urological
departments in Denmark was presented. Patients were enrolled and randomized 1:1
to either flexible BLC with Hexvix or white light (WL) only cystoscopy at the
time of first follow up after TURBT. Primary endpoint was tumor recurrence
within eight months from the randomization. A total of 351 patients were
allocated to the flexible BLC, and 348 to the control group). Throughout the
following 8 months after randomization, only 117 patients in the BLC group had
at least one tumor recurrence compared to 143 patients in the control group (P=
0.049). Odds ratio of 0.67 (P= 0.02, 95% CI: 0.48-0.95) correlates with a tumor
reduction of 33% in favor of the BLC group.

The study authors (Ditte Drejer, Anne-Louise Moltke, Anna Munk Nielsen, Gitte
Wrist Lam, Jørgen Bjerggaard Jensen) conclude that use of BLC in the first
routine surveillance cystoscopy after TURBT for NMIBC** reduces subsequent risk
of tumor recurrence compared to WL cystoscopy alone.

The study abstract can be found here (p. 48):
http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf

Experiences with flexible BLC with Hexvix in 119 patients at Lillebælt hospital
in Denmark were also presented. Flexible BLC with Hexvix was introduced to
replace procedures traditionally performed with rigid cystoscopes under general
anesthesia; in control after intravesical treatment in high-risk patients, in
patients with positive cytology and negative WL cystoscopy, in suspicious
mucosal abnormalities under WL and in treatment of small recurrences.

The authors (Karen Spanggaard, Karsten Zieger, Gitte Kissow, Louise Fauerholt
Øbro) conclude that flexible BLC and the possibility to biopsy in gel anesthesia
was well tolerated and patient satisfaction was high. For most patients, BLC
enabled treatment to be completed in the office. BLC was found to increase
detection of urothelial disease and to add valuable information to WL cystoscopy
and cytology.

The study abstract can be found here (p. 47):
http://urologi.dk/sites/default/files/begivenheder/dus_bog_final_version_0.pdf

TURBT: trans-urethral resection of bladder tumors

** NMIBC: non-muscle invasive bladder cancer

About Bladder Cancer

Bladder cancer ranks as the ninth most common cancer worldwide with 430 000 new
cases and more than 165 000 deaths annually. 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. MIBC is when 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].

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

Hexvix[®]/Cysview[®] is a drug that is selectively taken up by tumor 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 US and Canada, Hexvix[®] is the tradename in
all other markets. Photocure is commercializing Cysview[®] / Hexvix[®] directly
in the US 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.

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.

References

Globocan. Incidence/mortality by population. Available
at: http://globocan.iarc.fr/Default.aspx

Babjuk M, Burger M, Zigeuner R, Shariat SF, van Rhijn BW, Compérat E, et al.
EAU Guidelines on

non-muscle-invasive bladder cancer (Ta, T1 and CIS). Eur Urol. 2016
Guidelines Edition:1-40.

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

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

For more information, please contact:

Dan Schneider
President and CEO
Photocure ASA
Tel: + 1-609 759-6515
Email: [email protected]

Erik Dahl
CFO
Photocure ASA
Tel: +4745055000
Email: [email protected]

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

Kilde

Snoeffelen · november 18, 2019, 7:22am

Dette er bare helt konge!!!

Det er vel mange av oss som har ment at det må være slik at når man finner flere lesjoner med flexiscopet må det på sikt ende opp i færre tilbakefall. Og masse dokumentasjon har vist at det bør være en slik sammenheng.

Men nå er det for første gang vist i et randomisert studie. Det er er et aldri så lite kvantesprang.

Dette er f** meg gode nyheter

Savepig · november 18, 2019, 7:27am

Randomiserte studier er det som virkelig får respekt

Nocturne · november 18, 2019, 7:40am

Spent på om den tar ut 60 på denne meldingen

Savepig · november 18, 2019, 7:47am

Topp 20 har våknet til live forrige uke og, solid økning

Rodjer · november 18, 2019, 8:01am

Nå har jeg for n’te gang tipset e24 og Hegnar om å få dette på trykk.
Det er forkastelig at de må tipses hver gang Photocure melder noe flott.
At et lite norsk selskap kan bidra sterkt i kampen mot blærekreft worldwide burde virkelig fram i medielyset

solskimm · november 18, 2019, 8:04am

https://finansavisen.no/nyheter/tjenester/2019/11/18/7473358/positivt-studie-resultat-fra-photocure

@Rodjer, du alene kan stå for en god del av %-oppgangen til Pho det siste året

Rodjer · november 18, 2019, 8:11am

Hehe, neida, jeg kan nok ikke det, men det er viktig å få fra de gode meldingene og historiene og ikke bare:
“Fortsatt underskudd i Photocure”
“Betalt analyse fra Edison”

Etc.etc.

Jeg vet ikke om dem lager noen artikler idag, men de får hvertfall ikke fred.

Rodjer · november 18, 2019, 8:15am

@solskimm
I farten så jeg ikke linken om artikkelen, hehe.
Flott at de tar tak, håper artikkelen var bra også.

TekBot · november 21, 2019, 8:14am

Photocure fundamentale forhold (PHO)

Photocure ASA: Results for the third quarter of 2019

Photocure: First trial demonstrating reduced recurrence after flexible Blue Light Cystoscopy with Hexvix[®] in surveillance

Financial calendar