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Beskrivning

LandNorge
ListaOB Match
SektorHälsovård
IndustriMedicinteknik
Photocure är verksamma inom medicinteknik. Bolaget specialiserar sig inom lösningar för fotodynamisk teknik. Idag används lösningarna för behandling av sjukdomar som föranlett cancer i urinblåsan och HPV. Huvudmarknaderna återfinns inom dermatologi och onkologi, där produkterna används av sjukhus och forskningsinstitut på global nivå. Bolaget grundades 1993 och har huvudkontor i Oslo, Norge.
2020-04-27 16:52:55
HIGHLIGHTS

  · Photocure has reached an agreement with Ipsen to regain rights for the sales
and marketing of Hexvix[®] in Europe
  · The transaction is expected to be EBITDA accretive from FY 2021
  · Ipsen achieved Hexvix 2019 sales of EUR 18.7 million and Photocure sees
significant growth opportunities in Europe

Oslo, Norway, 27 April 2020: Photocure ASA (Photocure, PHO: OSE) has reached an
agreement with Ipsen Pharma SAS (Ipsen) on key terms for the return of Hexvix
sales, marketing and distribution rights in Europe and other markets currently
controlled by Ipsen. With taking direct control over Photocure's own
Hexvix/Cysview product in key regions, the company supports the ambition of
becoming a global leader in bladder cancer with a solid basis for expansion and
further growth opportunities. Following a final agreement, Photocure will
commence the Hexvix commercialization in Europe from the fourth quarter of 2020
and expects the potential Ipsen agreement to be EBITDA accretive from full-year
2021 and beyond.

"We have agreed terms with Ipsen for a transformative agreement in our strategy
of building a strong and profitable global business within the diagnosis and
treatment of bladder cancer. We have built a successful commercial organization
for Hexvix/Cysview in the U.S. and the Nordics, with a solid underlying growth
potential post the COVID-19 situation. Photocure aims to apply lessons learned
in Nordic and U.S. and sees significant growth opportunities in Europe and other
markets currently not served by Ipsen," says Dan Schneider, President and CEO,
and continues:

"The agreement will provide a platform for growth when returning to normal
market conditions and we see the terms as financially highly attractive. The
agreement is expected to be EBITDA accretive from full-year 2021 and beyond.
Photocure sees major opportunities in Europe for accelerated growth and
expansion going forward."

Photocure entered into a global commercialization agreement with Ipsen in 2011
for the sales, marketing and distribution of Hexvix outside the Nordic region
and the U.S. Ipsen has served as strategic partner and has built a solid
position for the brand in select key European markets. Photocure today announces
that the company has agreed terms for an agreement with Ipsen to regain the
global commercialization of Hexvix following the company's pure-play bladder
cancer focus, solid track-record from other markets and a commercial opportunity
provided by Ipsen's strategic priorities going forward.

"The alliance with Ipsen was entered into at a time where Photocure was set on
developing multiple medical solutions based on our photodynamic technology
platform. Photocure has since re-positioned the company and decided to focus
exclusively on bladder cancer. To retrieve the rights for developing Hexvix in
major markets brings flexibility and expansion at a perfect point in time. There
is a considerable and growing interest in the bladder cancer market, as the
disease remains the most expensive cancer to treat, and we see significant
opportunities ahead," Schneider comments.

The parties have entered into a term sheet setting out the key terms and
conditions for an agreement. Pursuant to the term sheet, Photocure will, by the
fourth quarter of 2020, pay Ipsen EUR 15 million and at the same date regain all
Hexvix marketing rights from Ipsen subject to satisfaction of closing
conditions. Ipsen will book sales up until these dates. Ipsen will in addition
receive earn-out payments in the range of 10-15% of sales (years 1-7 post
-termination) and 7.5% of sales (years 8-10) in the current Ipsen markets.

Current market conditions are affected by the COVID-19 virus outbreak. The
development in both Photocure's operations as well as relevant financial markets
in general may have a significant impact on the feasibility of concluding any
agreement. See OSE notification of 7 April 2020 for an in-depth analysis of risk
and effects of the COVID-19 situation.

The final agreement with Ipsen will be subject to customary terms and
conditions, as well as adequate financing to complete settlement. Photocure had
a cash position at the end of 2019 of NOK 125 million and may in addition
satisfy the financing condition by way of equity or debt, or a combination
thereof. Further, Photocure has had advanced discussions and received offers
from debt providers, and agreements on financing may be entered into to ensure
completion of settlement.

Photocure expects to outline the following key financial targets for the
acquired rights, pending a final agreement:

  · 2019 royalty received by Photocure was NOK 61 million excluding IFRS
adjustments. Following the potential transfer of the rights for the Ipsen
territories to Photocure, the revenue recognized by Photocure is expected to
increase around 3x to 2021 compared to 2019, driven by Photocure being granted
the in-market sale in the territories and growth in market penetration. Beyond
FY 2021, Photocure is targeting 20-30% annual revenue growth in current Ipsen
territories
  · NOK 30 million in integration and ramp-up costs in 2020
  · Around NOK 90 million in increased SG&A costs in Europe from FY 2021 and
beyond, with NOK 30-35 million increase for 2020

Outlines updated potential group 2023 ambitions

Photocure delivers transformative solutions which improve the lives of bladder
cancer patients. Based on experience and the performance of the breakthrough
bladder cancer product Hexvix/Cysview, Photocure has embarked on a stepwise
approach to continued growth. Photocure sees significant long-term value
creation potential in the global bladder cancer market and has developed a
defined growth strategy:

  · Accelerating - Drive the breadth and depth of Hexvix/Cysview usage in key
accounts
  · Expanding - Generate sales in new geographies and product enhancements
  · Acquiring - Products used in the management of bladder cancer patients
  · Transforming - Partner and in-license assets to strengthen the bladder
cancer portfolio

The primary growth geographies for Photocure are the U.S. and European markets
with large untapped market opportunities. The company will regain the sales and
marketing rights from Ipsen in the fourth quarter of 2020 and sees significant
growth opportunities in Europe. The agreement is expected to be EBITDA accretive
from full-year 2021 and beyond.

Based on the outlook and strategic opportunities, Photocure aims to increases
its group revenue ambitions for 2023 in the range of NOK 1 billion with EBITDA
margins of approximately 40%, following the completion of the potential
transaction.

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
first quarter 2020 financial report on pages 20-21.

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



Notes to editors

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 U.S. and Canada, Hexvix[®] is the tradename
in all other markets.

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 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

About Ipsen
Ipsen is a global specialty-driven biopharmaceutical group focused on innovation
and Specialty Care. The Group develops and commercializes innovative medicines
in three key therapeutic areas - Oncology, Neuroscience and Rare Diseases. Its
commitment to oncology is exemplified through its growing portfolio of key
therapies for prostate cancer, neuroendocrine tumors, renal cell carcinoma and
pancreatic cancer. Ipsen also has a well-established Consumer Healthcare
business. With total sales over  Euro 2.5 billion in 2019, Ipsen sells more than
20
drugs in over 115 countries, with a direct commercial presence in more than 30
countries. Ipsen's R&D is focused on its innovative and differentiated
technological platforms located in the heart of the leading biotechnological and
life sciences hubs (Paris- Saclay, France; Oxford, UK; Cambridge, US). The Group
has about 5,800 employees worldwide. Ipsen is listed in Paris (Euronext: IPN)
and in the United States through a Sponsored Level I American Depositary Receipt
program (ADR: IPSEY). For more information on Ipsen, visit www.ipsen.com.



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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.

Important information

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 of Photocure ASA (the
"Company"). 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 the Company 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.

Actual events may differ significantly from any anticipated development due to a
number of factors, including without limitation, changes in investment levels
and need for the Company's services, changes in the general economic, political
and market conditions in the markets in which the Company operate, the Company's
ability to attract, retain and motivate qualified personnel, changes in the
Company's ability to engage in commercially acceptable acquisitions and
strategic investments, and changes in laws and regulation and the potential
impact of legal proceedings and actions. Such risks, uncertainties,
contingencies and other important factors could cause actual events to differ
materially from the expectations expressed or implied in this release by such
forward-looking statements. The Company does not provide any guarantees that the
assumptions underlying the forward-looking statements in this announcement are
free from errors nor does it accept any responsibility for the future accuracy
of the opinions expressed in this announcement or any obligation to update or
revise the statements in this announcement to reflect subsequent events. You
should not place undue reliance on the forward-looking statements in this
announcement or any of its attachments.

The information, opinions and forward-looking statements contained in this
announcement speak only as at its date and are subject to change without notice.
The Company does not undertake any 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.

Even if Ipsen and Photocure have agreed terms, are participating in advanced
discussions, are positive and see business benefits from a potential transfer,
no final agreement setting out that the transfer of Hexvix sales, marketing and
distribution rights to Photocure will be made has been entered into. There can
be made no guarantees that the current agreement on terms and ongoing
discussions will lead to any agreement or the completion of any transfer or as
to the terms of any transfer.

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 the Company.

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