Basilea reports 2012 financials with a solid cash position and significant milestones ahead

Basilea reports 2012 financials with a solid cash position and significant 
milestones ahead 
BASEL, SWITZERLAND -- (Marketwire) -- 02/07/13 --  Basilea
Pharmaceutica AG / Basilea reports 2012 financials with a solid cash
position and significant milestones ahead . Processed and transmitted
by Thomson Reuters ONE. The issuer is solely responsible for the
content of this announcement. 
* CFO Joachim Blatter to depart company, CEO Ronald Scott to serve as
interim CFO 
* Cash position and short-term investments increased to CHF 344.0
million 
* Target patient recruitment reached in two isavuconazole phase 3
studies with data expected in H2 2013 
* European regulatory review of ceftobiprole in pneumonia ongoing
with first potential approval in Q4 2013 
* Toctino(R) agreement with potential U.S. filing by Stiefel early
2014 
Basilea Pharmaceutica Ltd. (SIX: BSLN) presented today full-year
financial results for 2012 with an increased year-end
cash position
of CHF 344.0 million and a reduced net loss of CHF 53.0 million.
CFO
Joachim Blatter will be leaving the company to pursue other
opportunities.
Ronald Scott, CEO will serve as interim CFO effective
February 7, 2013. 
2012 was a transformational year. Basilea took the strategic decision
to focus
its activities on anti-infective and oncology drugs and
entered into an agreement for its dermatology drug Toctino(R)
(alitretinoin) with Stiefel, a GSK company, for a CHF 224.1 million
initial payment and additional potential payments related to the
commercialization of Toctino(R) in the U.S. Stiefel has assumed
responsibility for the development, manufacturing and
commercialization
of Toctino(R). Basilea is eligible for a further
milestone payment related to the launch of alitretinoin in the U.S.
and will participate in future U.S. product
sales. Toctino(R) 2012
sales through completion of the Stiefel agreement were
CHF 20.2
million, in line with the company's guidance. 
In 2012, Basilea advanced the isavuconazole phase 3 program in
collaboration
with Astellas and filed a ceftobiprole Marketing
Authorization Application submission for severe pneumonia in Europe.
In addition, Basilea completed its
U.S. phase 3 study for
alitretinoin. 
The isavuconazole SECURE phase 3 registration study, evaluating
safety and efficacy of once-daily isavuconazole versus twice-daily
voriconazole for the
primary treatment of life-threatening invasive
fungal disease caused by Aspergillus species completed patient
recruitment. In addition, enrollment into
the isavuconazole VITAL
study, an open-label phase 3 study in the treatment of
aspergillosis
patients with pre-existing renal impairment or with invasive fungal
disease caused by rare but often fatal molds, has achieved its
initially
targeted recruitment of patients. Enrollment will continue
to further expand the database on the use of isavuconazole in the
primary treatment of diverse rare
mold infections. Topline data from
these two isavuconazole phase 3 studies are
expected in the second
half of 2013 and could result in a first potential filing
in the
first quarter of 2014. Under the agreement with Astellas, Basilea is
eligible for milestone payments related to filing, approval and
sales, and double-digit royalty payments. Furthermore, Basilea
retains co-promotion rights
on the drug and will evaluate these
rights as the drug comes closer to the market. The isavuconazole
ACTIVE phase 3 study, evaluating the use of isavuconazole i.v. and
oral versus caspofungin i.v. followed by oral voriconazole for the
treatment of invasive Candida infections, will likely continue to
recruit into 2014. Basilea and its partner Astellas are
reviewing
potential filing strategies including a first filing of the
SECURE and VITAL
studies. 
In 2012, Basilea also focused on bringing ceftobiprole to the market,
initially
for patients with severe lung infections. Basilea submitted
a Marketing Authorization Application in Europe for the treatment of
pneumonia which was
accepted for review in October 2012. Currently
the company focuses on answering
the questions received from the
European agencies. Basilea had a consultation
meeting with the FDA in
2012 and will continue its discussions with the FDA to
receive the
agency's final recommendation on the indications that could
potentially be supported by the existing data package. The FDA
requested that
Basilea conduct further analyses of the existing phase
3 dataset to assist FDA
in developing a final recommendation. A
follow-up consultation meeting for a
discussion of the data is
envisaged in the second quarter of 2013. Basilea is
managing the
ceftobiprole supply chain to support a potential regulatory approval
and launch and is engaged in discussions with potential partners. 
Basilea's commitment to address the medical challenge of resistance
in the areas
of anti-infectives and oncology is also reflected in its
phase 1 programs with
innovative compounds from in-house research,
addressing high medical needs in
these focus areas. The novel
antibiotic BAL30072 is intended for the treatment
of
multidrug-resistant Gram-negative bacteria where current antibiotics
often
fail, and the new oncology drug BAL101553 focuses on the
treatment of tumors
resistant to current cancer therapies. Basilea
made substantial progress during
2012 in advancing these compounds in
clinical phase 1 development. BAL30072 moved into its next stage of
phase 1 testing and BAL101553 is anticipated to
move into phase 2a
studies in 2013. 
Ronald Scott, CEO stated: "We made significant achievements in 2012.
Through the Toctino transaction we improved our cash position and we
will continue to prudently invest our resources to achieve our key
value-driving events. Now we
are focused on our important milestones
for 2013, including the potential approval of ceftobiprole in Europe
and first anticipated isavuconazole phase 3 topline data." He added:
"Basilea is uniquely positioned through our innovative
drug portfolio
to address the increasing threat posed by multi-drug
resistant
infections and drug resistant cancers for which there are
currently limited treatments available. The critical need to address
drug resistance is gaining
increasing awareness. Recent measures
taken by several countries further encourage the development of novel
antibiotics and antifungals for the treatment
of drug-resistant
life-threatening infections by providing potential benefits
that
could result in shorter development and regulatory timelines and
longer
market exclusivity." Related to the departure of Joachim
Blatter he said: "We
want to thank Joachim for his contributions, and
wish him all the best for his
new endeavors." 
Key figures 


 
 
+-----------------------------------------------------+---------+------
---+
| (In CHF million, except per share data)             |  2012   |  2011   |
+-----------------------------------------------------+---------+---------+
| Product sales*                                      |  20.2   |  31.0   |
+-----------------------------------------------------+---------+---------+
| Contract revenue                                    |  37.4   |  35.2   |
+-----------------------------------------------------+---------+---------+
| Revenue from R&D services                           |   0.2   |   0.6   |
+-----------------------------------------------------+---------+---------+
| Other income                                        |   0.5   |   0.2   |
+-----------------------------------------------------+---------+---------+
| Total operating income                              |  58.3   |  66.8   |
+-----------------------------------------------------+---------+---------+
|         Cost of sales                               |  (4.4)  |  (2.4)  |
+-----------------------------------------------------+---------+---------+
|         Research & development expenses             | (58.9)  | (70.0)  |
+-----------------------------------------------------+---------+---------+
|         Selling*, general & administrative expenses | (45.9)  | (51.7)  |
+-----------------------------------------------------+---------+---------+
| Total operating expenses                            | (109.2) | (124.1) |
+-----------------------------------------------------+---------+---------+
| Operating loss                                      | (50.8)  | (57.3)  |
+-----------------------------------------------------+---------+---------+
| Net loss                                            | (53.0)  | (57.6)  |
+-----------------------------------------------------+---------+---------+
| Net cash provided by/used for operating activities  |  148.2  | (82.4)  |
+-----------------------------------------------------+---------+---------+
| Cash and short-term investments                     |  344.0  |  197.1  |
+-----------------------------------------------------+---------+---------+
| Basic and diluted loss per share, in CHF            | (5.53)  | (6.01)  |
+-----------------------------------------------------+---------+---------+

 
Notes: Consolidated figures in conformity with US GAAP; rounding was
consistently applied. 
*2012 numbers: Through July. 
The consolidated financial statements of Basilea Pharmaceutica Ltd.
for 2012 can be found on the company's website at
http://annualreport.basilea.com. 
Financial summary 
Product sales in 2012 for Toctino(R) were within guidance amounting
to CHF 20.2 million, through July 2012, when the Stiefel transaction
closed (full-year 2011: CHF 31.0 million). 
Contract revenue in 2012 amounted to CHF 37.4 million (2011: CHF 35.2
million),
including CHF 16.1 million related to the agreement with
Stiefel on Toctino(R),
CHF 12.8 million related to Toctino(R)
distribution agreements and CHF 8.2 million related to the license
agreement with Astellas for isavuconazole. Total operating income
decreased to CHF 58.3 million in 2012 (2011: CHF 66.8
million)
primarily due to the shorter product sales period as a
result of the agreement
with Stiefel on Toctino(R) in July 2012. 
Research and development expenses amounted to CHF 58.9 million in
2012, compared
to CHF 70.0 million in 2011. This decrease is mainly
due to the completion of
the alitretinoin phase 3 U.S. study in the
first half of 2012 and Basilea fulfilling its financial participation
commitment in the development of isavuconazole under the license
agreement with Astellas. Selling, general and
administrative expenses
decreased to CHF 45.9 million in 2012 (2011: CHF 51.7
million)
primarily due to closing Basilea's commercial organizations
following
its Toctino(R) agreement with Stiefel in the second half of
2012. 
In 2012, the operating loss decreased to CHF 50.8 million from CHF
57.3 million
in 2011, mainly due to lower research and development
costs as well as lower
selling, general and administrative expenses.
As a result of this, the average
monthly operating loss for 2012 was
CHF 4.2 million. The net loss 2012 amounted
to CHF 53.0 million,
compared to CHF 57.6 million in 2011. 
2012 basic and diluted loss per share amounted to CHF 5.53 compared
to basic and diluted loss per share of CHF 6.01 in 2011. 
In 2012, the net cash provided by operating activities was CHF 148.2
million as compared to net cash used by operating activities of CHF
82.4 million in 2011,
mainly due to the upfront payment of CHF 224.1
million received from Stiefel for the Toctino(R) agreement. Combined
cash and short-term investments increased to CHF 344.0 million as of
December 31, 2012, compared to CHF 197.1 million at year-end 2011. 
Financial outlook 
Total operating expenses for 2013 are estimated to decrease to around
CHF 7  to
8 million per month primarily due to the Toctino(R)
transaction and Basilea having fulfilled in 2012 its financial
participation commitment related to the development of isavuconazole.
Basilea's average operating loss in 2013 is estimated at around CHF 4
to 5 million per month. 
Portfolio 
Isavuconazole - a novel intravenous and oral broad-spectrum
antifungal, partnered with Astellas Pharma Inc., for the potential
treatment of severe invasive and life-threatening fungal infections 
Isavuconazole demonstrated excellent 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 less
prevalent but often fatal
molds such as Mucorales spp. It has U.S.
FDA fast-track status. In clinical studies to date it achieved
predictable drug levels and high oral bioavailability suggesting the
potential for predictable dosing and a switch
from i.v.
administration to convenient once-daily oral dosing. 
Ceftobiprole - a novel broad-spectrum antibiotic for the potential
first-line empiric treatment of severe multidrug-resistant bacterial
infections 
Ceftobiprole has unique 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. Ceftobiprole
has met the study endpoints in several phase III studies and has
shown a typical cephalosporin safety profile. 
BAL30072 - a novel innovative sulfactam antibiotic with bactericidal
activity
against multidrug-resistant Gram-negative bacteria 
The investigational drug has demonstrated broad in-vitro and in-vivo
coverage of Gram-negative pathogens including multidrug-resistant
Pseudomonas aeruginosa and Acinetobacter baumannii. It has robust
activity against common strains of bacteria that produce
antibiotic-inactivating enzymes including extended-spectrum
beta-lactamases (ESBL) and metallo-beta-lactamases such as the New
Delhi metallo-beta-lactamase 1 (NDM-1). In addition, BAL30072 has
been shown to enhance the activity of antibiotics from the penem
class. 
BAL101553 - a novel small-molecule anti-cancer drug with a dual mode
of action
directly attacking tumor cells as well as disrupting tumor
blood vessels 
BAL101553 disrupts the intracellular microtubule network that is
essential for
cell division and has shown potent activity in many
tumor cell lines that are
insensitive or resistant to taxanes or
other microtubule-targeting agents. In
contrast to currently
available microtubule-targeting agents that are derived
from complex
natural products, BAL101553 is a simpler synthetic molecule
that
bypasses some of the resistance mechanisms associated with
existing drugs. BAL101553 was developed as a highly water-soluble
prodrug of Basilea's BAL27862
with anticipated good oral
bioavailability and an injectable formulation without
potentially
harmful solubilizers. 
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 III and not yet approved by the FDA. In July 2012, Basilea
completed an agreement for Toctino(R)
with Stiefel, a GSK company. 
Conference call 
Basilea Pharmaceutica Ltd. invites you to participate in a conference
call on
Thursday, February 7, 2013, 4 p.m. (CET), during which the
company will discuss
today's press release. 
Dial-in numbers are: 


  +41 (0) 91 610 56 00       (Europe and ROW)
 
  +1 (1) 866 291 4166        (USA)
 
  +44 (0) 203 059 5862       (UK)

 
A playback will be available 1 hour after the conference call until
Monday, February 11, 2013, 6 p.m. (CET). 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 18060 followed by the # sign. 
Note to shareholders 
The shareholders of Basilea Pharmaceutica Ltd. are informed that the
Ordinary
General Meeting of Shareholders of Basilea Pharmaceutica
Ltd. will take place on Tuesday, April 9, 2013 at 2 p.m. at the
Hilton Hotel in Basel, Switzerland. The
invitation will be published
in the Swiss Official Gazette of Commerce (Schweizerisches
Handelsamtsblatt, SHAB). Shareholders who are recorded in the
share
register with voting rights on March 28, 2013 will be entitled to
participate and exercise their voting rights. 
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/1676249/546280.pdf 
This announcement is distributed by Thomson Reuters on behalf of
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(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: Basilea Pharmaceutica AG via Thomson Reuters ONE 
[HUG#1676249] 
For further information, please contact: 
Media Relations 
Peer Nils Schroder, Ph.D
Head Public Relations &
Corporate Communications
+41 61 606 1102
media_relations@basilea.com 
Investor Relations 
Barbara Zink, Ph.D., MBA
Head Corporate Development 
+41 61 606 1233
investor_relations@basilea.com
 
 
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