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2015-08-14

Basilea Pharmaceutica AG: Basilea reports 2015 half-year results - Major milestones achieved for CRESEMBA® and Zevtera®

Basilea Pharmaceutica AG / Basilea reports 2015 half-year results - Major
milestones achieved for CRESEMBA®and Zevtera® . Processed and transmitted by
NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the
content of this announcement.
* Antifungal CRESEMBA® (isavuconazole) received U.S. approval and is
recommended for approval in the European Union
* Antibiotic Zevtera®/Mabelio® (ceftobiprole medocaril) launched in four
European countries
* Ceftobiprole designated as a Qualified Infectious Disease Product for the
treatment of lung and skin infections by U.S. FDA
* Additional oncology program (panRAF kinase inhibitor BAL3833) entered phase
1 of clinical development
* Cash and short-term investments of CHF 218.4 million

Basel, Switzerland, August 14, 2015

- Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today its financial results
for the first half of the financial year 2015 with a solid half-year cash
position of CHF 218.4 million. Basilea achieved significant milestones in the
first part of 2015. The antifungal isavuconazole received U.S. approval and
was launched under the trade name of CRESEMBA®in the United States by
Basilea's licensing partner Astellas Pharma Inc. for the treatment of the
invasive mold infections aspergillosis and mucormycosis in adults.
Furthermore, the European Medicines Agency's Committee for Medicinal Products
for Human Use (CHMP) recommended isavuconazole for regulatory approval as a
new treatment for the invasive mold infections aspergillosis and
mucormycosis. A final decision from the European Commission is expected in
the coming months. Basilea has launched its antibiotic Zevtera®(ceftobiprole
medocaril)* in four European markets, France, Italy, the United Kingdom and
Germany. A possible launch in Spain is planned by end-2015 or the beginning
of 2016. To fully access the commercial value of Zevtera®, Basilea is in
discussions with potential partners for further territories, including the
U.S. The U.S. FDA designated ceftobiprole as a Qualified Infectious Disease
Product (QIDP) for the potential treatment of community-acquired bacterial
pneumonia and acute bacterial skin and skin structure infections.

Ronald Scott, Basilea's CEO, stated: "We continue to grow the company from a
solid base as we focus on our major value drivers. We are now commercializing
Zevtera in a number of major European countries. At the same time, we are
actively preparing for a potential launch of isavuconazole in Europe. There
is high commercial synergy between these two hospital anti-infectives." He
added: "Basilea is committed to bring innovative therapies to patients and we
look forward to the European Commission's decision regarding a potential
approval of isavuconazole in the fourth quarter of 2015."

David Veitch, Chief Commercial Officer of Basilea, commented: "Invasive mold
infections represent the most important part of the market in terms of
medical need and value. Isavuconazole is clearly positioned in this segment.
We are in preparations for a potential launch of isavuconazole in Europe
early next year." He added: "We are also currently focused on the market
entry of our antibiotic Zevtera. Following the roll-out of the country
launches, Zevtera sales are expected to accumulate steadily over time as
hospitals gain experience with Zevtera and it becomes a routine treatment.
Treatment failure rates in pneumonia caused by MRSA are still high and have
been attributed in part to inadequate initial antibiotic therapy. Pneumonia
patients require effective, fast-acting and well-tolerated treatment, and
appropriate initial therapy is very important to decrease mortality,
morbidity and length of hospital stay. Here Zevtera addresses an important
unmet medical need by offering a new first line antibiotic treatment option."

Prof. Achim Kaufhold, Chief Medical Officer of Basilea, said: "In addition to
the important achievements in our anti-infectives portfolio, we have
strengthened our oncology portfolio during the first half of the year. The
panRAF kinase inhibitor program entered phase 1 clinical development.
Substances from this series have shown promising activity in preclinical
models of resistant tumors. Furthermore, for the tumor checkpoint controller
BAL101553 we are looking forward to the read-out of a phase 2a study in
advanced solid tumor patients in the second half of the year."

Key figures

----------------------------------------------------------------
| (In CHF million, except per share data) H1 2015 H1 2014 |
| Contract revenue 24.4 20.2 |
| Revenue from research&development services 0.4 0.1 |
| Other revenue 0.2 0.0 |
| Total revenue 25.0 20.3 |
| Research&development expenses, net (31.2) (27.5) |
| Selling, general&administrative expenses (23.8) (12.3) |
| Total operating expenses (55.0) (39.8) |
| Operating loss (30.0) (19.5) |
| Net loss (30.1) (19.4) |
| Net cash (used for) operating activities (19.3) (44.9) |
| Cash and short-term investments 218.4 245.9 |
| Basic and diluted loss per share, in CHF (3.0) (1.97) |
----------------------------------------------------------------
Notes: Consolidated figures in conformity with US GAAP; rounding was
consistently applied.

The unaudited condensed consolidated financial statements of Basilea
Pharmaceutica Ltd. for the first half-year 2015 can be found on the company's
website athttp://interimreport.basilea.com.

Financial summary

Contract revenue in the first half of 2015 amounted to CHF 24.4 million (H1
2014: CHF 20.2 million), including CHF 18.8 million (H1 2014: CHF 18.5
million) related to the global agreement with Stiefel for Toctino®and CHF 5.6
million (H1 2014: CHF 1.7 million) related to the license agreement with
Astellas for isavuconazole. Total revenues in H1 2015 amounted to CHF 25.0
million (H1 2014: CHF 20.3 million).

Research and development net expenses amounted to CHF 31.2 million in H1 2015
(H1 2014: CHF 27.5 million) and were mainly related to activities to support
the launch preparation for isavuconazole in Europe, for maintaining the
supply chain for isavuconazole, progressing the phase 2a development of
BAL101553 and strengthening the oncology portfolio by in-licensing panRAF
kinase inhibitors as well as to supporting exploratory research programs. The
Company recognized CHF 3.6 million in H1 2015 (H1 2014: CHF 3.3 million)
under the agreement with BARDA related to the reimbursement of agreed
development costs for BAL30072.

Selling, general and administrative expenses increased to CHF 23.8 million (H1
2014: CHF 12.3 million), mainly related to the commercialization of
ceftobiprole in Germany, France, Italy and the UK and activities to prepare
and support a potential launch of isavuconazole in major European countries.

In H1 2015, operating loss amounted to CHF 30.0 million, compared to CHF 19.5
million in H1 2014. This change is mainly due to higher operating expenses
related to commercial activities for ceftobiprole and pre-launch activities
for isavuconazole. The net loss amounted to CHF 30.1 million (H1 2014: CHF
19.4 million) and the basic and diluted loss per share to CHF 3.00 (H1 2014:
CHF 1.97).

The net cash used for operating activities in H1 2015 amounted to CHF 19.3
million as compared to CHF 44.9 million in 2014. The decrease is mainly due
to the milestone payment of CHF 30.0 million received from Astellas in H1
2015 upon approval of isavuconazole in the U.S.

Combined cash and short-term investments amounted to CHF 218.4 million as of
June 30, 2015, compared to CHF 226.1 million as of December 31, 2014.

Financial outlook

Basilea remains focused on establishing Zevtera®in hospitals in Germany,
France, Italy and the UK and launching the drug in Spain end-2015 or
beginning of 2016. The company is also preparing for the potential launch of
isavuconazole in Europe. Total operating expenses for 2015 are estimated at
approximately CHF 9 million on average per month. Basilea's operating loss in
2015 is estimated at approximately CHF 4-5 million on average per month.

Pipeline update

CRESEMBA®(isavuconazole)
-an intravenous and oral broad-spectrum azole antifungal for the treatment of
severe invasive fungal infections - approved in the U.S. and recommended for
regulatory approval in the European Union for invasive mold infections

Isavuconazole is being co-developed with Astellas Pharma Inc. under an
agreement granting Astellas license rights in the U.S.; Basilea holds full
rights to isavuconazole in markets outside the United States. Astellas
launched CRESEMBA®in the United States in April 2015 following FDA's
regulatory approval for the treatment of invasive aspergillosis and invasive
mucormycosis in adults. Basilea is entitled to receive royalties and sales
milestones on Astellas' U.S. sales of isavuconazole. The European Medicines
Agency's Committee for Medicinal Products for Human Use (CHMP) recommended
isavuconazole for regulatory approval as a new treatment for invasive
aspergillosis and mucormycosis in the European Union.

The isavuconazole phase 3 ACTIVE study in invasiveCandida
infections did not meet its primary endpoint. The key secondary endpoint of
the study, overall response rate at two weeks after treatment, was, however,
comparable between the two treatment groups. In addition, the secondary
endpoint of all-cause mortality was comparable at study day 14 and day 56 in
both treatment groups. Additional analyses of the data will be performed to
assess the potential role of isavuconazole in invasiveCandida
infections.

Zevtera®/Mabelio®(ceftobiprole medocaril)

- a broad-spectrum intravenous cephalosporin antibiotic - marketed in European
countries

Zevtera®/Mabelio®(European trade names of ceftobiprole, depending on the
country) is a new generation broad-spectrum cephalosporin antibiotic with
bactericidal activity against Gram-positive and Gram-negative bacteria
associated with pneumonia, including methicillin-resistantStaphylococcus
aureus
(MRSA) and susceptiblePseudomonas
spp.

Ceftobiprole has received national licenses for the treatment of adult
patients with community- and hospital-acquired pneumonia (CAP, HAP),
excluding ventilator-associated pneumonia (VAP) in 13 European countries* and
has been launched in Germany, France, Italy and the United Kingdom.
Ceftobiprole is not registered in the United States.

The FDA designated ceftobiprole in August as a Qualified Infectious Disease
Product (QIDP) for the potential treatment of community-acquired bacterial
pneumonia and acute bacterial skin and skin structure infections. The QIDP

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