Pronova BioPharma ASA: Strong financial performance and patents upheld

Pronova BioPharma ASA: Strong financial performance and patents upheld

ID: 174703

(Thomson Reuters ONE) -


15. August 2012, Lysaker, Norway: Pronova BioPharma announced second quarter and
first half year results for 2012 with revenues of respectively NOK 445.8
million, up 17.1 percent compared with the second quarter 2011, and NOK 926.7
million, up 11.4 percent compared with the same period last year. EBITDA was NOK
217.6 million in the quarter, representing a 44.3 per­cent increase over the
same period last year, and NOK 442.6 million in the first half year, up 34.9
percent over corresponding period in 2011.

Pronova BioPharma also had a very strong cash flow in the period with operating
cash flow reaching NOK 233.1 million in the second quarter and 453.7 million in
the first half year. The financial posi­tion of the Company was further
strengthened in the first half year of 2012 with a reduction in net debt of NOK
275.3 million despite dividend payments to shareholders of NOK 150.4 million in
May.

Moving annual total (MAT) end-user demand for Pronova BioPharma's prescription
drug in its current eight largest markets, as measured by IMS, fell 1 percent
overall due to ongoing economic pressures in the USA. MAT volumes were 1 256
tonnes. This repre­sents USD 1 360 million in drug sales on a MAT basis, up 1
percent year-on-year, ensuring that Pronova BioPharma's pharmaceutical product
remains a blockbuster.

In May the U.S. District Court for the District of Delaware ruled in Pronova
BioPharma's favour in the patent litigation against Teva and Par. The court
found that Pronova BioPharma's claims were valid, enforceable and would be
infringed by Teva and Par. The Lovaza(TM) patents in question, U.S. Patent Nos.
5,656,667 (expiring in April 2017) and 5,502,077 (expiring in March 2013), are
owned by Pronova BioPharma and licensed to GlaxoSmithKline in the United States
and Puerto Rico. Teva and Par have appealed the decision.





Teva, Sandoz and Momaja have obtained authorisations to market generic versions
of a 1 gram soft capsule omega-3 acid ethyl ester in certain European countries.
Pronova BioPharma and its com­mercial partners have been working closely
together to ensure the continued success of the product in Europe in the
evolving com­petitive environment.

Geographical expansion continued with new launches in Brazil, Argentina, India
and Morocco; the pharmaceutical product is now launched in 60 countries. Further
geographical launches are expected in the coming 2-3 years. The biggest
opportunity lies in Japan, which is on track for approval in 2012 and launch in
2013.

Pronova BioPharma is organised in three divisions: The Phar­maceutical Division;
The Consumer Healthcare Division and the Clinical Nutrition Division.

The Consumer Healthcare Division received its first B2B order and started own
manufacturing for the dietary supplements market in the quarter, representing a
significant achievement in developing its busi­ness for the fast-growing omega-
3 consumer healthcare market. The official launch of Pronova BioPharma's B2B
consumer healthcare busi­ness is on track for November 2012, and will leverage
the Company's existing infrastructure, expertise, research, regulatory and
partnership capabilities. New plant technology is being implemented on time and
on budget allowing commercial production from the Triglyceride plant from 2013.
In addition, development of new technology for production of different
concentrates is progressing well and meetings with poten­tial B2C partners are
ongoing with expected conclusion in the first half of 2013. Pronova BioPharma is
currently developing 5 dietary sup­plement products aligned with the new vision
board of the Consumer Healthcare Dision. The organisation is also taking form
with key posi­tons being filled by experienced consumer market specialities.

Further progress has also been made in developing the clinical nutrition
business. In June, the Clinical Nutrition Division held its first advisory board
meeting of global key opinion leaders in the sector, to help define and position
the offering. In August, the Clinical Nutrition Division expects to sign an
agreement with a renowned academic institution to conduct a clinical research
pro­ject which should help to develop a strong scientific foundation for the
business. Pronova BioPharma also continues to engage in com­mercial discussions
with potential key clinical nutrition partners, with positive initial feedback.

As announced last quarter, Pronova BioPharma is conducting fur­ther tests to
evaluate PRC-4016, the Group's leading research and development candidate, at
higher dose levels. The product contin­ues to display a high degree of
tolerability. The tests are expected to be completed in the fourth quarter of
2012, after which the Group expects to move the product into Phase II clinical
trials.

Pronova BioPharma maintains its outlook for 2012 with revenue and EBITDA growth.

Pronova BioPharma's Chief Executive Officer Morten Jurs com­mented, "We achieved
another strong financial performance in the second quarter of 2012. Furthermore,
we secured an important victory in the U.S. patent trial, with a ruling
upholding all of our challenged patents and paving the way for further
development of the Lovaza(TM) brand in our largest market. With our first order
in consumer healthcare, important advancements in developing the clinical
nutrition business and strong safety signals in our R&D trials, we continue to
make significant progress towards further strengthening and diversifying our
company."



This information is subject of the disclosure requirements acc. to §5-12 vphl
(Norwegian Securities Trading Act)

Report Q2 12:
http://hugin.info/137506/R/1633895/524456.pdf



This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.

Source: Pronova BioPharma ASA via Thomson Reuters ONE
[HUG#1633895]




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Bereitgestellt von Benutzer: hugin
Datum: 15.08.2012 - 07:00 Uhr
Sprache: Deutsch
News-ID 174703
Anzahl Zeichen: 6799

contact information:
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Lysaker



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