Basilea Pharmaceutica AG : Basilea reports 2012 financials with a solid cash
position and significant milestones ahead
Basilea Pharmaceutica AG / Basilea reports 2012 financials with a solid cash
position and significant milestones ahead . Processed and transmitted by
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*CFO Joachim Blatter to depart company, CEO Ronald Scott to serve
*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® agreement with potential U.S. filing by Stiefel early 2014
Basel, Switzerland, February 7, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
presented today full-year financial results for 2012 with an increased
year-end cash position of CHF 344.0million and a reduced net loss of
CHF53.0million. 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® (alitretinoin) with Stiefel, a GSK
company, for a CHF 224.1 million initial payment and additional potential
payments related to the commercialization of Toctino® in the U.S. Stiefel has
assumed responsibility for the development, manufacturing and
commercialization of Toctino®. 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® 2012 sales through completion of the
Stiefel agreement were CHF20.2million, 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
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."
(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
*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.
Product sales in 2012 for Toctino® 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 CHF16.1 million related to the agreement with Stiefel on
Toctino®, CHF 12.8 million related to Toctino® 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® in July 2012.
Research and development expenses amounted to CHF 58.9 million in 2012,
compared to CHF70.0 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: CHF51.7 million) primarily due to closing Basilea's commercial
organizations following its Toctino® agreement with Stiefel in the second half
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 CHF4.2 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® 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.
Total operating expenses for 2013 are estimated to decrease to around CHF 7 to
8 million per month primarily due to the Toctino® 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.
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
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 Acinetobacterbaumannii. 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® (oral alitretinoin) - the only licensed drug for systemic use in
adults with severe chronic hand eczema unresponsive to potent topical
Toctino® 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®
with Stiefel, a GSK company.
Basilea Pharmaceutica Ltd. invites you to participate in a conference call on
Thursday, February7, 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, 6p.m. (CET). Participants requesting a digital playback
+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.
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.
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.
For further information, please contact:
Media Relations Investor Relations
Peer Nils Schröder, Ph.D. Barbara Zink, Ph.D., MBA
Head Public Relations & Head Corporate Development
+41 61 606 1102 +41 61 606 1233
This press release can be downloaded from www.basilea.com.
Press Release (PDF)
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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