Basilea reports 2013 half-year financials with improved operating results

Basilea reports 2013 half-year financials with improved operating results 
BASEL, SWITZERLAND -- (Marketwired) -- 08/21/13 --  Basilea
Pharmaceutica Ltd. (SIX: BSLN) 
* Continued improvement in financial performance 
* Cash and short-term investments of CHF 262.8 million 
* Guidance on isavuconazole phase 3 topline data and ceftobiprole
regulatory decision in Europe maintained for H2 2013 
* Significant agreement with BARDA of up to USD 89 million funding
for novel antibiotic BAL30072 announced in H1 2013 
Basilea Pharmaceutica AG / Basilea reports 2013 half-year financials
with improved operating results. Processed and transmitted by Thomson
Reuters ONE. 
The issuer is solely responsible for the content of this
announcement. 
Basilea Pharmaceutica Ltd. (SIX: BSLN) announced today financial
results for the first half-year 2013 with improved operating results,
a net loss of CHF 17.3 million and cash and short-term investments of
CHF 262.8 million at the end of the period. 
In the first six months of 2013, Basilea made substantial progress
toward the company's major milestones: the reporting of the
isavuconazole phase 3 data and a potential approval of ceftobiprole.
In addition, the company continued to advance its earlier-stage
clinical programs. 
For the antifungal isavuconazole, Basilea and its partner Astellas
Pharma Inc. are currently preparing the phase 3 data analyses of the
SECURE study in aspergillosis and the VITAL study in aspergillosis
patients with kidney impairment or with invasive fungal disease
caused by emerging and often fatal fungi. Topline data continues to
be expected in H2 2013. 
In Europe, the regulatory procedure of the marketing authorization
application for Basilea's broad-spectrum, anti-MRSA antibiotic
ceftobiprole for the treatment of pneumonia in the hospital is moving
forward according to plan. If the regulatory decision anticipated in
H2 2013 is positive, first approvals of ceftobiprole in Europe would
be possible this year. Regarding the U.S., the FDA indicated that
their current guidelines mandating two pivotal trials per indication
are still valid. Basilea is continuing its discussions with the
agency. 
Basilea's continued commitment to address the medical challenges of
resistance is demonstrated by the progress made on Basilea's two
phase 1 compounds from its research. Both drug candidates are unique
and highly differentiated from current therapies or drugs in
development. Due to the broad activity of BAL30072 against
multidrug-resistant Gram-negative pathogens including those that pose
a biothreat, the Biomedical Advanced Research and Development
Authority (BARDA), a division within the U.S. Department of Health
and Human Services, entered a contract with Basilea for up to USD 89
million for the development of BAL30072. The phase 1 development of
BAL30072, which will include combination studies with antibiotics
from the carbapenem class is ongoing. 
First evidence of anti-tumor activity from phase 1 study data was
presented in June at the Annual Meeting of the American Society of
Clinical Oncology (ASCO) for Basilea's novel
microtubule-destabilizing and vascular disrupting anti-cancer drug,
BAL101553. The program is anticipated to transition into phase 2a of
clinical development this year following establishment of the maximum
tolerated dose in the ongoing phase 1 study. 
Stiefel is in the process of preparing for a U.S. filing of
alitretinoin for the treatment of severe refractory chronic hand
eczema planned for 2014. Basilea participates in the U.S.
alitretinoin opportunity through a milestone payment related to the
launch of the product and royalties on future U.S. sales. 
Ronald Scott, Basilea's CEO stated: "Basilea is committed to fight
the growing global threat of resistance against established therapies.
We continue to focus on achieving our key milestones for this year
including a potential approval of our antibiotic ceftobiprole in
Europe, reporting phase 3 results for our antifungal isavuconazole
and continued improvement of our financial performance. We remain
open to explore innovative collaboration and transaction structures
and we were very pleased to announce a significant agreement with
BARDA allowing for
non-dilutive funding of up to USD 89 million for
our drug candidate BAL30072, which addresses Gram-negative bacterial
resistance." 
Key figures 


 
+--------------------------------------------------+---------+---
------+
| (In CHF million, except per share data)          | H1 2013 | H1 2012 |
+--------------------------------------------------+---------+---------+
| Product sales                                    |    -    |  17.7   |
+--------------------------------------------------+---------+---------+
| Contract revenue                                 |  20.4   |  13.4   |
+--------------------------------------------------+---------+---------+
| Revenue from R&D services                        |   0.1   |   0.1   |
+--------------------------------------------------+---------+---------+
| Other income                                     |   0.1   |   0.0   |
+--------------------------------------------------+---------+---------+
| Total operating income                           |  20.6   |  31.2   |
+--------------------------------------------------+---------+---------+
|      Cost of sales                               |    -    |  (5.1)  |
+--------------------------------------------------+---------+---------+
|      Research & development expenses             | (26.7)  | (31.6)  |
+--------------------------------------------------+---------+---------+
|      General & administrative/Selling, general & | (11.3)  | (28.7)  |
|      administrative expenses                     |         |         |
+--------------------------------------------------+---------+---------+
| Total operating expenses                         | (38.0)  | (65.5)  |
+--------------------------------------------------+---------+---------+
| Operating loss                                   | (17.4)  | (34.2)  |
+--------------------------------------------------+---------+---------+
| Net loss                                         | (17.3)  | (34.6)  |
+--------------------------------------------------+---------+---------+
| Net cash used for operating activities           | (33.7)  | (47.6)  |
+--------------------------------------------------+---------+---------+
| Cash and short-term investments                  |  262.8  |  149.0  |
+--------------------------------------------------+---------+---------+
| Basic and diluted loss per share, in CHF         | (1.80)  | (3.61)  |
+--------------------------------------------------+---------+---------+

 
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 2013 can be found on the
company's website at http://interimreport.basilea.com. 
Financial summary 
In the first six months of the financial year 2013, contract revenues
increased to CHF 20.4 million (H1 2012: CHF 13.4 million), mainly
driven by the revenue recognition associated with the agreement for
Toctino(R) concluded with Stiefel in July 2012. Following the
transaction, Toctino(R) sales were recorded by Stiefel, leading to a
decrease in total operating income for the first six months of 2013
to CHF 20.6 million (H1 2012: CHF 31.2 million). 
Research and development expenses were CHF 26.7 million in the first
six months of 2013, compared to CHF 31.6 million in the first six
months of 2012. This decrease is mainly due to Basilea's fulfillment
of its commitment to contribute to isavuconazole development costs in
the first half of 2012. 
As a consequence of the transfer of the Toctino(R) business to
Stiefel, selling, general and administrative expenses were
significantly reduced from CHF 28.7 million in the first half of 2012
to CHF 11.3 million in the first half of 2013. Total operating
expenses in the first six months of 2013 were CHF 38 million compared
to CHF 65.5 million of the corresponding 2012 period. 
As a result of these factors, and driven by Basilea's prudent
financial management, operating loss in the first six months of 2013
was reduced by approximately 50 percent to CHF 17.4 million (H1 2012:
CHF 34.2 million) and the net loss of the period decreased to CHF
17.3 million, compared to CHF 34.6 million in the corresponding
period in 2012. The basic and diluted loss per share was reduced to
CHF 1.80 for the first six months of 2013 compared to CHF 3.61 for
the respective 2012 period. In the first six months of 2013, net cash
used for operating activities was CHF 33.7 million as compared to CHF
47.6 million in the first six months of 2012. 
At the Ordinary General Meeting of Shareholders in April, Basilea's
shareholders approved the distribution of CHF 5.00 per share,
corresponding to CHF 48.0 million, from capital contribution reserves.
The payment was made in June. As of June 30, 2013, Basilea's combined
cash and short-term investments were CHF 262.8 million, compared to
CHF 149.0 million as of June 30, 2012, and to CHF 344.0 million
(including the upfront payment of CHF 224.1 million from Stiefel
following the Toctino(R) agreement) as of December 31, 2012. 
Financial outlook 
Total average operating expenses for 2013 are estimated to decrease
to approximately CHF 7 million per month primarily due to the
agreement with BARDA and continued prudent expense management.
Basilea's average operating loss in 2013 is estimated to improve to
approximately CHF 4 million per month. 
Portfolio 
Isavuconazole - an investigational intravenous and oral
broad-spectrum antifungal, partnered with Astellas Pharma Inc., for
the potential treatment of severe invasive and life-threatening fungal
infections (phase 3 clinical development) 
Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad
range of yeasts (such as Candida species) and molds (such as
Aspergillus species) as well as in-vitro activity against emerging
and often fatal molds including those that cause mucormycosis. In
clinical studies isavuconazole achieved predictable drug levels in
patients, supporting reliable once-daily dosing and a switch from
intravenous to oral administration. Isavuconazole received U.S. FDA
fast-track and U.S. orphan drug designation. 
Ceftobiprole - an investigational broad-spectrum intravenous
antibiotic for the potential first-line empiric treatment of severe
bacterial infections (under regulatory review in Europe for the
potential treatment of pneumonia in the hospital) 
Ceftobiprole has demonstrated broad-spectrum activity against
Gram-positive bacteria including methicillin-resistant and
vancomycin-resistant Staphylococcus aureus (MRSA, VRSA) and
penicillin-resistant Streptococcus pneumoniae (PRSP) as well as
Gram-negative pathogens, including Enterobacteriaceae and Pseudomonas
aeruginosa. 
BAL30072 - an intravenous bactericidal sulfactam antibiotic against
multidrug-resistant Gram-negative bacterial infections (phase 1
clinical development) 
BAL30072 demonstrated in-vitro and in-vivo coverage of Gram-negative
pathogens including multidrug-resistant Acinetobacter baumannii and
Pseudomonas aeruginosa. It has robust activity against common strains
of resistant bacteria that produce antibiotic-inactivating enzymes
including carbapenemases and metallo-beta-lactamases such as the New
Delhi metallo-beta-lactamase 1 (NDM-1). In addition, BAL30072 has
shown additive or synergistic activity with antibiotics from the
carbapenem class. Basilea entered a contract with BARDA for up to USD
89 million in funding for the development of BAL30072. 
BAL101553 - an intravenous and oral small-molecule
anti-cancer drug
with a dual mode of action (phase 1 clinical development) 
BAL101553 directly attacks tumor cells by destabilizing the
intracellular microtubule network that is essential for cell division.
In addition, it disrupts tumor blood vessels depriving the tumor from
nutrition. The drug has shown potent anti-proliferative activity in a
panel of tumor models, including many that are not responsive to
conventional microtubule-targeting agents, such as taxanes, as a
result of diverse resistance mechanisms. BAL101553 is a water-soluble
prodrug of Basilea's BAL27862, formulated as an injectable dosage
form without potentially harmful solubilizers. In addition, it is
orally bioavailable. 
Toctino(R) (oral alitretinoin) - the only licensed drug for systemic
use in adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids 
Toctino(R) was developed and successfully brought to market by
Basilea. In the U.S., oral alitretinoin is an investigational drug in
phase 3 and not yet approved by the FDA. In July 2012, the Toctino(R)
business was transferred to Stiefel, a GSK company. Basilea is
eligible for a milestone payment related to the U.S. launch of
alitretinoin and participation in future U.S. product sales. 
Conference call 
Basilea Pharmaceutica Ltd. invites you to participate in a conference
call on Wednesday, August 21, 2013, 4 p.m. (CEST), during which the
company will discuss today's press release. 
Dial-in numbers are: 
+41 (0) 58 310 50 00   (Europe and ROW) 
+1 (1) 631 570 5613    (USA) 
+44 (0) 203 059 5862   (UK) 
A playback will be available 1 hour
after the conference call until Friday, August 23, 2013, 6 p.m.
(CEST). Participants requesting a digital playback may dial: 
+41 (0) 91 612 4330    (Europe and ROW) 
+1 (1) 866 416 2558    (USA) 
+44 (0) 207 108 6233   (UK) 
and will be asked to enter the ID
17234 followed by the # sign. 
About Basilea 
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland,
and listed on the SIX Swiss Exchange (SIX: BSLN). Through the fully
integrated research and development operations of its Swiss subsidiary
Basilea Pharmaceutica International Ltd., the company focuses on
innovative pharmaceutical products in the therapeutic areas of
bacterial infections, fungal infections and oncology, targeting the
medical challenge of rising resistance and non-response to current
treatment options. 
Disclaimer 
This communication expressly or implicitly contains certain
forward-looking statements concerning Basilea Pharmaceutica Ltd. and
its business. Such statements involve certain known and unknown
risks, uncertainties and other factors, which could cause the actual
results, financial condition, performance or achievements of Basilea
Pharmaceutica Ltd. to be materially different from any future
results, performance or achievements expressed or implied by such
forward-looking statements. Basilea Pharmaceutica Ltd. is providing
this communication as of this date and does not undertake to update
any forward-looking statements contained herein as a result of new
information, future events or otherwise. 
This press release can be downloaded from www.basilea.com. 
Press release (PDF): http://hugin.info/134390/R/1724040/574612.pdf 
This announcement is distributed by Thomson Reuters on behalf of
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(ii) they are solely responsible for the content, accuracy and     
originality of the information contained therein. 
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1724040] 
For further information, please contact: 
Media Relations
Peer Nils Schroder, PhD
Head Public Relations & Corporate Communications
+41 61 606 1102
media_relations@basilea.com 
Investor Relations
Barbara Zink, PhD, MBA
Head Corporate Development
+41 61 606 1233
investor_relations@basilea.com
 
 
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