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2016-02-29

Basilea Pharmaceutica AG: Basilea reports solid 2015 full-year results and is launching CRESEMBA®, its second hospital anti-infective, in Europe

Basilea Pharmaceutica AG / Basilea reports solid 2015 full-year results and is
launching CRESEMBA®, itssecond hospital anti-infective, in Europe . Processed
and transmitted by NASDAQ OMX Corporate Solutions.The issuer is solely
responsible for the content of this announcement.
* CRESEMBA® approval in U.S. and Europe and launched in the U.S. by Astellas
* Zevtera® launched in major European countries
* Tumor checkpoint controller BAL101553 interim phase 2a (i.v.) study data
reported and phase 1 (oral) study initiated; oncology panRAF-SRC kinase
inhibitor BAL3833 phase 1 initiated
* CHF 200 million convertible bonds issued, year-end cash and short-term
investments of CHF 364.7 million

Basel, Switzerland, February 29, 2016

- Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today its financial results
for the financial year 2015 with a solid year-end cash position of 364.7
million and a net loss of CHF 61.6 million reflecting Basilea's investment in
the launch of its two hospital anti-infective drugs, Zevtera® and CRESEMBA®.

Ronald Scott, Basilea's Chief Executive Officer, stated: "We achieved
significant milestones in 2015. The approval of isavuconazole in the U.S. and
Europe was an important step for Basilea. We are now able to provide a new
treatment option for life-threatening invasive fungal infections after almost
a decade during which there were no new drugs introduced in this area of high
medical need. In addition, we built a dedicated commercial organization in
our core European markets to launch CRESEMBA in addition to Zevtera. 2015
also marked the strengthening of our oncology pipeline. We initiated an oral
phase 1 clinical study for our tumor checkpoint controller and introduced a
second oncology drug candidate, a panRAF-SRC kinase inhibitor, into clinical
testing."

Isavuconazole was approved by the U.S. Food and Drug Administration (FDA) for
the treatment of invasive aspergillosis and invasive mucormycosis in adults
and launched under the tradename CRESEMBA® by Basilea's licensee Astellas
Pharma U.S. In Europe, isavuconazole was approved by the European Commission
for the treatment of invasive aspergillosis in adults and the treatment of
mucormycosis in adults for whom amphotericin B is inappropriate. Following
submission of pricing and reimbursement dossiers for all major European
markets, Basilea is launching CRESEMBA® initially in the UK and Germany, to
be followed by Italy and France.

In addition to Germany, Basilea launched Zevtera® (ceftobiprole), its
anti-MRSA broad-spectrum antibiotic for the treatment of severe bacterial
lung infections in 2015 in France, Italy, the U.K. and Austria and achieved
first formulary inclusions at the regional and hospital level. In 2015,
Basilea expanded the commercial availability of Zevtera® to the Middle East
and North Africa (MENA) region through a distribution agreement with Hikma.

To potentially bring the drug to the U.S. market, Basilea is currently
preparing phase 3 study protocols in community-acquired bacterial pneumonia
(CABP), acute bacterial skin and skin structure infections (ABSSSI), and
Staphylococcus aureus bacteremia. Basilea plans to submit these protocols to
the FDA to request Special Protocol Assessments (SPAs).

Ceftobiprole has been assigned Qualified Infectious Disease Product (QIDP)
status by the U.S. FDA for CABP and ABSSSI that results in a total of ten
years of market exclusivity from marketing authorization in the U.S. Part of
the proceeds from the issuance of the convertible bonds at the end of 2015
may be used for a financial participation by Basilea in the potential
ceftobiprole phase 3 clinical program to gain U.S. regulatory approval.

Basilea initiated the development of an inhaled formulation of its
Gram-negative antibiotic BAL30072 for the treatment of bacterial lung
infections in cystic fibrosis and bronchiectasis patients with the iABC
(inhaled Antibiotics in Bronchiectasis and Cystic fibrosis) consortium, which
is part of the European New Drugs for Bad Bugs (ND4BB) program launched
within the EU's Innovative Medicines Initiative (IMI).

In addition, Basilea advanced its oncology product candidates in 2015. The
panRAF-SRC kinase inhibitor, BAL3833 for targeted cancer therapy, entered
clinical phase 1. The compound potentially offers a new treatment option for
resistant melanoma and other cancers. Furthermore, the tumor check point
controller BAL101553 completed recruitment into a phase 1/2a study with its
intravenous formulation. Interim data of that study showed first signals of
clinical benefit in heavily pretreated solid tumor patients. BAL101553's oral
formulation, currently in phase 1 development, potentially offers increased
dosing flexibility for both single agent and drug combination treatment
strategies. In particular its development for the treatment of brain cancer,
an area of high medical need, is supported by its brain penetration and
potent activity against glioblastoma tumor and stem-like cells and further
preclinical data.

CEO Ronald Scott added further: "For 2016 we are focused on launching CRESEMBA
in our major European markets. We plan to further expand Zevtera's formulary
access and increase sales in our major European markets. In addition, we are
actively discussing Zevtera and CRESEMBA distribution agreements for further
territories. We aim to enter a collaboration for ceftobiprole phase 3
development in additional indications to potentially bring the drug to the
important U.S. market. Furthermore, we plan to advance our oncology portfolio
by expanding our BAL101553 phase 1 oral clinical study to include
glioblastoma patients."

Key figures

---------------------------------------------------------------
| (In CHF million, except per share data) 2015 2014 |
| Contract revenue 51.2 42.1 |
| Revenue from R&D services 0.5 0.4 |
| Other revenue 1.2 0.1 |
| Total operating income 52.8 42.6 |
| Research&development expenses, net (60.1) (54.4) |
| Selling, general&administration expenses (54.2) (30.1) |
| Total operating expenses (114.3) (84.5) |
| Operating loss (61.5) (41.8) |
| Net loss (61.6) (41.5) |
| Net cash (used for) operating activities (67.8) (71.5) |
| Cash and short-term investments 364.7 226.1 |
| Basic and diluted loss per share, in CHF (6.09) (4.17) |
---------------------------------------------------------------
Notes: Consolidated figures in conformity with US GAAP; rounding was
consistently applied.

The consolidated financial statements of Basilea Pharmaceutica Ltd. for 2015
can be found on the company's website athttp://annualreport.basilea.com.

Financial summary

Contract revenue 2015 amounted to CHF 51.2 million (2014: CHF 42.1 million),
including CHF 37.6 million (2014: CHF 36.9 million) related to the global
agreement with Stiefel, a GlaxoSmithKline (GSK) company, for Toctino® and CHF
13.6 million (2014: CHF 5.2 million) related to the license agreement with
Astellas for isavuconazole. Total operating income in 2015 including sales
amounted to CHF 52.8 million (2014: CHF 42.6 million).

Research and development net expenses amounted to CHF 60.1 million (2014: CHF
54.4 million) and were mainly related to activities for the phase 1/2a
development of oncology drug candidate BAL101533, costs for the initiation of
a pediatric program for ceftobiprole, activities related to the isavuconazole
program including pre-launch inventory expenses, and the further development
of antibiotic BAL30072.

Selling, general and administration expenses amounted to CHF 54.2 million
(2014: CHF 30.1 million), and were mainly related to commercial activities to
prepare and support the launch of isavuconazole under the trade name
CRESEMBA® in major European countries and the commercialization of
ceftobiprole under the trade name Zevtera®/Mabelio® in Germany, France, Italy
and the UK.

In 2015, operating loss amounted to CHF 61.5 million, compared to CHF 41.8
million in 2014. This change is mainly due to higher operating expenses
related to commercial activities for Zevtera®/Mabelio® and pre-launch
activities for CRESEMBA®. The net loss amounted to CHF 61.6 million (2014:
CHF 41.5 million) and the basic and diluted loss per share to CHF 6.09 (2014:
CHF 4.17).

The net cash used for operating activities in 2015 amounted to CHF 67.8
million as compared to CHF 71.5 million in 2014. The decrease is mainly due
to the milestone payment of CHF 30.0 million received from Astellas in 2015
upon approval of isavuconazole in the U.S.

Combined cash and short-term investments amounted to CHF 364.7 million as of
December 31, 2015, compared to CHF 226.1 million as of December 31, 2014.

Financial outlook

Basilea is focused on launching and establishing CRESEMBA® in hospitals in
Germany, France, Italy and the UK in 2016 and on commercializing
Zevtera®/Mabelio® in hospitals in major European countries. Total operating
expenses for 2016 are estimated at approximately CHF 9 - 10 million on
average per month. Basilea's average operating loss in 2016 is estimated at
approximately CHF 4 - 5 million per month. Total annual product sales are
expected at approximately CHF 5 million.

Pipeline status

CRESEMBA® (isavuconazole)
-an intravenous ( i.v). and oral azole antifungal marketed in the U.S. and in
certain EU countries for invasive mold infections

Isavuconazole is the active agent of the prodrug isavuconazonium sulfate.
Isavuconazole was co-developed with Astellas Pharma Inc. under an agreement
granting Astellas a license to commercialize isavuconazole in the U.S.
Basilea holds full isavuconazole rights in markets outside the United States.
CRESEMBA® was approved in March 2015 by the U.S. FDA for the use for patients
18 years of age and older in the treatment of invasive aspergillosis and
invasive mucormycosis. Basilea benefits from Astellas' U.S. sales through
royalties and sales milestone payments. The European Commission granted
marketing authorization in October 2015 to isavuconazole for the treatment of
adult patients with invasive aspergillosis and for the treatment of adult
patients with mucormycosis for whom amphotericin B is inappropriate. The
European marketing authorization is valid in all 28 European Union (EU)
member states, as well as in Iceland, Liechtenstein and Norway.

In July 2015, Basilea announced top-line data from the ACTIVE trial of
isavuconazole in patients with invasive candidiasis or candidemia. The ACTIVE
study did not meet its primary endpoint (non-inferior efficacy of
isavuconazole versus the study comparator at the end of i.v. therapy). The
overall response rates at two week...

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