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controlled by Ipsen Pharma SAS (Ipsen). Photocure and Ipsen have today entered
into a final agreement.
“We have entered into a final agreement with Ipsen that will have a
transformative impact on Photocure, in line with 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 has a unique understanding of
the disease and bladder cancer care. We aim to apply lessons learned in the
Nordic region and the U.S. and see significant growth opportunities in Europe
and other markets currently not served by Ipsen,” says Dan Schneider, President
and CEO.
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 announced on 27
April 2020 that the company had agreed terms for an agreement with Ipsen to
regain the global commercialization of Hexvix, an extensive commercial
opportunity going forward, consistent with the company’s pure-play bladder
cancer focus and solid track-record from other markets. The parties have today
entered into a final agreement in which commercial rights will be officially
transferred to Photocure on 1 October 2020.
"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 concludes.
The parties have entered into a final agreement were Photocure will pay Ipsen
EUR 15 million upon transfer on 1 October 2020. Ipsen will book sales up until
this date. Ipsen will in addition 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
current Ipsen markets.
Photocure had a cash position at the end of the first quarter of 2020 of NOK 127
million and conducted a private placement on 27 April 2020 raising NOK 143
million in gross proceeds. Reference is made to OSE notifications 27 and 28
April regarding the private placement.
Photocure outlines the following key financial targets for the acquired rights:
· 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 approximately 30% annual revenue growth in
current Ipsen territories
· Photocure will incur approximately NOK 30 million in integration and ramp-up
costs in 2020
· Photocure will incur approximately NOK 90 million in increased SG&A costs in
Europe from FY 2021 and beyond.
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 sees significant growth
opportunities in Europe and other countries not currently commercialized by
Ipsen. The agreement is expected to be EBITDA accretive from full-year 2021 and
beyond.
Based on the outlook and strategic opportunities, Photocure targets group
revenues for 2023 in the range of NOK 1 billion with EBITDA margins of
approximately 40%, following the completion of the transaction.
Market conditions are affected by the COVID-19 virus outbreak. See OSE
notification of 7 April 2020 for an in-depth analysis of risk and effects of the
COVID-19 situation, in addition the trading update 27 April 2020 and the first
quarter 2020 presentation and board of directors’ report of 7 May 2020.
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.
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.
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.
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.
Kilde
