OSLO, Norway, June 11, 2020 /PRNewswire/ -- Reference
is made to the OSE notification 27 April
2020 from Photocure ASA (PHO: OSE) regarding the return of
Hexvix® sales, marketing and distribution rights in
Europe and other markets currently
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.
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 (BLCTM). BLC™
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
1Globocan. Incidence/mortality by
population. Available at: http://globocan.iarc.fr/Pages/bar_pop_sel.aspx
2Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3Sievert KD et al. World J Urol 2009;
27:295-3004 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 €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.
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
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