
12
Annual Report Photocure – Results 2024
Activated Awareness – Demand
via advocacy groups, clinics’
advertising, and media
Acceleration – Commercial
investment in the U.S. to optimize
the opportunity.
Photocure plans to maximize the
return on its commercial investment
by growing its business in the largely
untapped U.S. market, as well as in
Europe where the Company expects
to see strong returns in the form
of revenue growth and improved
profitability. Reacquisition of the
broader European commercial rights
has given Photocure global control
of the Hexvix/Cysview brand, and the
opportunity to generate sales in major
countries in Europe where blue light
cystoscopy is underpenetrated or not
yet introduced.
On June 11, 2020, Photocure entered
into an agreement with Ipsen Pharma
SAS (Ipsen) regarding the return of
Hexvix sales, marketing and distribution
rights in Europe and other markets
previously controlled by Ipsen to the
Company. Commercial rights were
transferred to Photocure on October
1, 2020. Photocure paid Ipsen EUR
15 million upon transfer on October
1, 2020, and Ipsen booked sales until
this date. In addition, Ipsen is entitled
to receive earn-out payments in the
reacquired markets in the range of
10-15% of sales for the years 1-7 post-
transfer and 7.5% of sales for the years
8-10 post-transfer.
By taking direct control of Photocure’s
own Hexvix/Cysview product in key
regions, the Company is supporting its
ambition to become a global leader
in the treatment and management of
bladder cancer, with a solid commercial
foundation for expansion and further
growth opportunities.
Full year 2024 European segment
revenues increased 8.4% to NOK 285.6
million from NOK 263.5 million in 2023.
The increase was mainly driven by higher
unit volume, average price increases, and
a benefit from foreign exchange.
During 2024, several scientific
publications and presentations
highlighted and confirmed key benefits
of BLC with Hexvix/Cysview. Main
publications and presentations for the
year are below:
In March 2024, an article was
published in the medical journal
Cancers entitled Racial Difference
in Detection Rate of Bladder Cancer
Using Blue Light Cystoscopy:
Insights from a Multicenter Registry.
The study in the article evaluated
heterogeneity in characteristics of
blue light cystoscopy for detection
of malignant lesions among various
races with non-muscle invasive
bladder cancer (NMIBC). Overall,
2379 separate samples were
identified from 1292 patients, of
whom, 1095 (85%) were White/
Caucasian, 96 (7%) Black/African
American, 51 (4%) Asian and 50 (4%)
Hispanic. In all races, the sensitivity
of BLC was significantly higher than
WLC for detection of CIS (P<0.001).
Also, the addition of BLC to standard
WLC increased the detection rate
by 10% for any malignant lesion in
the total cohort. This rate increased
to 18% in Asian patients. Positive
predictive value of BLC was also
highest in the Asian population
(94.4%). The study authors
concluded that regardless of race,
BLC increased the detection of
bladder cancer when combined with
WLC. However, the difference was
more pronounced in Asian patients.
Link to publication
In April 2024, two clinical abstracts
featuring blue light cystoscopy were
presented in abstract sessions at
the 2024 European Association of
Urology (EAU) Annual Congress. The
first abstract evaluated whether
12-month recurrence-free survival
after out-patient department photo
coagulation of bladder tumors (PC-
BT) is non-inferior to PDD-assisted
TUR-BT in patients with recurrent
Ta low grade bladder tumor. For the
299 patients evaluable for 12-month
follow-up, the findings demonstrated
that the non-inferiority criterion was
met. Recurrence-free survival was
noninferior, incidence of long-term
stage progression after outpatient
PC-BT is noninferior to TUR-BT.
Accordingly, the study authors
noted that treatment of recurrent
Ta low grade intermediate risk
bladder tumor with outpatient PC-BT
appears to be a safe alternative to
TUR-BT. Link to abstract
The second abstract at the 2024
EUA Congress described the recent
Hexvix randomized controlled
Phase III trial in China in which 158
patients were enrolled, and 114
patients underwent Hexvix blue light
cystoscopy (BLC). Among patients
diagnosed with Ta, T1, or CIS, 42
out of 97 patients (43.3%) had at
least one lesion detected by BLC
but not by white light cystoscopy
(WLC) (p<0.0001). Thirteen patients
had CIS of which 11 (84.6%) showed
additional CIS lesions. The BLC
detection rates for PUNLMP, CIS,
Ta, T1, and T2 ~ T4 tumors were
NA, 94.7%, 100%, 98.2%, and
100%, respectively, while the WLC
detection rates were NA, 42.1%,
76.1%, 91.2%, and 100%. These
results confirm the superiority of
HAL BLC over WLC in the detection
of bladder cancer even if improved
WLC using HD 4K equipment is
utilized. In particular, additional high-
risk difficult to see CIS lesions were
identified in 85% of all CIS patients
only by HAL BLC. Link to abstract
In May 2024, a clinical abstract was
presented at the 2024 American
Urological Association (AUA) Annual
Congress. The abstract featured
results from the VA BRAVO (Bladder
Cancer Recurrence Analysis in
Veterans and Outcomes) study, a
retrospective, propensity score
matched analysis that evaluated
oncologic outcomes following