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2026-06-04 16:30:13
Oslo, Norway - June 4, 2026 - Photocure ASA (OSE: PHO), a leader in bladder
cancer diagnostics, today announced the signing and successful completion of its
acquisition of Vesica Health, a U.S. established precision diagnostics company
advancing AssureMDx, a urine-based molecular test for the early detection of
bladder cancer, in a transaction designed to expand Photocure's position across
the bladder cancer care continuum.
Transaction Highlights
· USD 30.5M in total cash + stock transaction
· Of which USD 3.0M equity investment made during Q1 2026.
· Net consideration of approx. USD 28.5M accounting for USD 2M of cash in
Vesica Health
· USD 13.75M due at close, comprised of USD 11.0M cash and USD 2.75M in
Photocure equity.
· USD 13.75M due based on two future milestones related to Medicare
reimbursement, comprised of USD 5.5M cash and USD 8.25M in Photocure equity.
· Advanced Diagnostic Laboratory Test (ADLT) milestone - USD 2.75M of
Photocure Equity if company achieves ADLT status designation on or prior to 1
October 2026 (if this is not achieved by that date, the USD 2.75M roll into the
second milestone).
· Centers for Medicare and Medicaid Services (CMS) milestone - USD 5.5M of
cash and USD 5.5M of Photocure equity if Vesica Health is awarded CMS
reimbursement prior to end of December 2029 (assuming the ADLT milestone rolls,
then the full milestone is USD 5.5M in cash and USD 8.25M in Photocure Equity).
· All equity considerations will be based on Volume Weighted Average Price
(VWAP) of Photocure on the Oslo Stock Exchange over the 30 trading days prior to
Close, which is concurrent with this announcement.
· Consideration due at Close will be funded through cash and treasury shares
on hand. Consideration due for milestones will be funded with available cash and
facilities.
· The equity consideration due for milestones may, pursuant to the agreement
with the sellers, be settled with the issuance of new shares or delivery of
treasury shares to the sellers.
· There are no financing conditions for the acquisition.
Strategic Rationale
The acquisition of Vesica Health adds a complementary noninvasive molecular
diagnostic capability to Photocure's precision diagnostics bladder cancer
portfolio, extending further reach upstream in the patient evaluation pathway.
Vesica Health offers AssureMDx, a multi-omic urine-based biomarker test designed
to support risk stratification and identify hematuria patients at increased risk
for bladder cancer to improve early detection. AssureMDx integrates six
epigenetic and somatic biomarkers to help inform urologic evaluation through a
urine-based testing approach.
Approximately seven million patients in the U.S. present with hematuria
annually, highlighting a substantial opportunity to improve patient
identification and risk stratification. AssureMDx has been validated in
prospective multicenter studies, including a large study of 838 hematuria
patients demonstrating 96% sensitivity, 99.7% Negative Predictive Value (NPV),
and 0.96 Area Under the Curve (AUC) for bladder cancer detection. The assay was
recognized in American Urological Association (AUA) guidelines in September 2025
for the evaluation of microhematuria, received an American Medical Association
(AMA) Proprietary Laboratory Analyses (PLA) code effective January 2026, and was
granted U.S. Food and Drug Administration (FDA) Breakthrough Device Designation
(BDD) in February 2026. As of May 14, 2026, a proposed Medicare ruling may
expedite future reimbursement pathway.
AssureMDx's commercialization can be significantly accelerated through
Photocure's established bladder cancer leadership, commercial infrastructure,
urology footprint, and payer relationships. For Photocure, the addition of
AssureMDx expands its portfolio with complementary noninvasive and procedural
diagnostic technologies across the bladder cancer care pathway. The acquisition
also expands Photocure's reach into the large and rapidly growing hematuria
evaluation market, supporting earlier patient risk stratification across
existing urology call points. In addition, AssureMDx is expected to create
meaningful operational and commercial synergies through expanded laboratory
capabilities, attractive gross margins, and leverage of Photocure's existing
customer relationships and commercial organization.
"This transaction represents a significant step forward in our strategy to build
a comprehensive bladder cancer platform," said Dan Schneider, Chief Executive
Officer of Photocure. "We believe that Photocure can expand on progress with
Blue Light Cystoscopy by building a portfolio of complementary precision
diagnostics to inform physician decision-making and provide value for patients
at different stages of the diagnostic pathway. By combining Vesica Health's best
-in-class hematuria early detection capabilities with our established diagnostic
solution and commercial infrastructure, we are well positioned to accelerate
growth and deliver improved outcomes for patients with urological cancers."
"AssureMDx represents a highly differentiated molecular assay designed to
support risk stratification and earlier evaluation of hematuria patients," said
Christopher Thibodeau, Chief Executive Officer of Vesica Health. "Noninvasive
genomic testing and blue light cystoscopy are highly complementary technologies
within the bladder cancer care continuum, and bringing these approaches together
through Photocure's established platform has the potential to accelerate
clinical adoption, support more informed clinical decision-making, and expand
access to advanced noninvasive bladder cancer diagnostics."
"As the evaluation of hematuria continues to evolve, there remains a significant
need for tools that can help identify patients at increased risk for bladder
cancer earlier in the diagnostic pathway," said Dr. Sam S. Chang, Professor of
Urology and Chief Surgical Officer at Vanderbilt-Ingram Cancer Center. "The
combination of noninvasive molecular testing such as AssureMDx with advanced
visualization technologies such as Blue Light Cystoscopy has the potential to
support more informed clinical decision-making and improve patient management
across the bladder cancer care continuum."
Business Outlook
· For full year 2026, Photocure continues to expect product revenue growth in
the range of 7% to 11% on a constant currency basis, alongside continued
expansion of adjusted EBITDA margins.
· Assuming Medicare reimbursement by mid-2028 and positive clinical readouts
supporting commercialization, Photocure expects initial AssureMDx revenues in
2027 and positive adjusted EBITDA contribution from AssureMDx operations by
2030, with market access and commercialization costs funded through free cash
flow.
· Modest Vesica Health operating losses expected in the near-term, quickly
ramping to segment EBITDA margins north of 30%.
· The consolidated business is expected to accelerate revenue growth from a
standalone mid-to-high teens CAGR to above 25% CAGR from 2026-2030, while
maintaining strong profitability with consolidated adjusted EBITDA margins above
25% by 2030 and additional upside potential.
· Importantly, completion of FDA down-classification, entry of additional
scope manufacturers into the U.S. market including reintroduction of flexible
scopes, will provide further upside to the standalone growth outlook.
Conference Call and Webcast
Photocure will host a conference call (https://qcnl.tv/p/lkosSsHzAixuKpKnBaC-WQ)
on June 5, 2026 at 11.00 CEST to discuss the transaction. A company presentation
is made available on the Photocure's website, www.photocure.com.
Advisers
DNB Carnegie, a part of DNB Bank ASA, acted as financial adviser. Morgan, Lewis
& Bockius LLP is acting as US legal adviser and Advokatfirmaet Selmer is acting
as Norwegian legal adviser to Photocure for this acquisition.
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 Photocure ASA
Photocure is a commercial diagnostic company with global reach, committed to
driving progress in uro-oncology precision diagnostics, delivering meaningful
advances for patients with urological cancers. Our unique core technology has
led to better health outcomes for patients worldwide. The company aims to
provide an array of transformative solutions that help physicians with timely
diagnostic information, to inform more personalized decisions on how best to
manage each individual patient. Photocure is headquartered in Oslo, Norway and
listed on the Oslo Stock Exchange (OSE: PHO). For more information, please visit
www.photocure.com.
About Vesica Health, Inc.
Vesica Health is a privately held precision diagnostics company pioneering
noninvasive solutions for the early detection and management of bladder cancer.
Headquartered in Irvine, California, Vesica operates a CAP-accredited, CLIA
-certified laboratory and holds worldwide commercialization rights for
AssureMDx. The company is led by an experienced team with a proven track record
in diagnostic development, clinical evidence generation, and commercial
execution. Learn more at: www.vesicahealth.com.
About Bladder Cancer
Bladder cancer ranks as the 8th most common cancer worldwide - the 5th 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
For more information, please contact:
Dan Schneider
President and CEO
Photocure ASA
Email: [email protected]
Priyam Shah
Vice President Investor Relations
Tel: +17176815072
Email: [email protected]
Media and IR enquiries:
Geir Bjørlo
Corporate Communications (Norway)
Tel: +47 91540000
Email: [email protected]
Important Information
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 Dick Peters, Corporate Controller of Photocure ASA
at the time and date stated above.
This announcement is not and does not form a part of any offer to sell, or a
solicitation of an offer to purchase, any securities. The distribution of this
announcement and other information may be restricted by law in certain
jurisdictions. Copies of this announcement are not being made and may not be
distributed or sent into any jurisdiction in which such distribution would be
unlawful or would require registration or other measures. Persons into whose
possession this announcement or such other information should come are required
to inform themselves about and to observe any such restrictions.
Matters discussed in this announcement may constitute forward-looking
statements. Forward-looking statements are statements that are not historical
facts and may be identified by words such as "believe", "expect", "anticipate",
"strategy", "intends", "estimate", "will", "may", "continue", "should" and
similar expressions. The forward-looking statements in this release are based
upon various assumptions, many of which are based, in turn, upon further
assumptions. Although Photocure believes that these assumptions were reasonable
when made, these assumptions are inherently subject to significant known and
unknown risks, uncertainties, contingencies and other important factors which
are difficult or impossible to predict and are beyond its control.
The information, opinions and forward-looking statements contained in this
announcement speak only as at its date and are subject to change without notice.
Photocure ASA undertakes no obligation to review, update, confirm, or to release
publicly any revisions to any forward-looking statements to reflect events that
occur or circumstances that arise in relation to the content of this
announcement, other than as required by law.
This announcement is for information purposes only and is not to be relied upon
in substitution for the exercise of independent judgment. It is not intended as
investment advice and under no circumstances is it to be used or considered as
an offer to sell, or a solicitation of an offer to buy any securities or a
recommendation to buy or sell any securities of Photocure. Neither Photocure nor
its advisors accept any liability arising from the use of this announcement.
This information is subject to the disclosure requirements pursuant to Section 5
-12 of the Norwegian Securities Trading Act.
n offer to sell\, or a solicitation of an offer to buy any securities or a\
recommendation to buy or sell any securities of Photocure. Neither Photocure nor\
its advisors accept any liability arising from the use of this announcement.\
\
This information is subject to the disclosure requirements pursuant to Section 5\
-12 of the Norwegian Securities Trading Act.\