Basilea Pharmaceutica AG / Basilea reports significantly improved
financial results in 2017 . Processed and transmitted by Nasdaq
Corporate Solutions. The issuer is solely responsible for the content of
this announcement.
-- 54% increase in total revenue, amounting to CHF 101.5 million
-- Operating loss reduced by 68% to CHF 14.1 million
-- Cash position as of year-end 2017 increased to CHF 310.7 million
-- License and distribution agreements in 2017 for Cresemba(R) and
Zevtera(R) cover more than 100 countries with CHF 80 million in upfront
payments and up to USD 1.1 billion potential milestone payments
Basel, Switzerland, February 27, 2018 - Basilea Pharmaceutica Ltd. (SIX:
BSLN) announced today its financial results for the financial year 2017
with total revenue increased to CHF 101.5 million (2016: CHF 66.0
million; +54% year-on-year), including product sales from Cresemba(R)
(isavuconazole) and Zevtera(R) (ceftobiprole) of CHF 16.3 million (2016:
CHF 7.1 million; +130%) and royalties on U.S. and European Cresemba
sales by Basilea's license partners of CHF 15.0 million (2016: CHF 7.3
million; +105%). Basilea reported CHF 310.7 million (year-end 2016: CHF
289.0 million; +7.5%) in cash and investments as of December 31, 2017
and a significantly reduced operating loss of CHF 14.1 million (2016:
CHF 43.9 million; -68%).
Chief Executive Officer Ronald Scott said: "2017 marked a successful
year in the implementation of our strategy to maximize the value of our
commercial-stage drugs Cresemba and Zevtera through partnerships. At the
same time our revenue from sales, royalties and revenue recognition
increased to over CHF 100 million while our operating loss reduced by
68% to approximately CHF 14 million bringing Basilea closer to
profitability. We received approximately CHF 80 million in upfront
payments from our new partners in 2017. Our license and distribution
agreements now cover more than 100 countries worldwide. In addition,
potential regulatory and sales milestone payments under our licensing
agreements amount up to USD 1.1 billion."
Anti-infectives: New partnerships create the basis for accelerated
commercial success
During 2017, Basilea entered into major partnerships for its two
marketed anti-infective drugs, the antifungal Cresemba (isavuconazole)
and the antibiotic Zevtera (ceftobiprole). In June, Basilea announced a
license agreement with Pfizer for Cresemba for more than 40 countries in
Europe (excluding the Nordics) plus Russia, Turkey and Israel. The
transaction completed in July, providing Basilea an upfront payment of
CHF 70 million. This agreement was then extended to cover China and
sixteen countries in the Asia Pacific region. Basilea receives mid-teen
royalties on sales by Pfizer in these territories and is eligible for up
to USD 650 million in regulatory and sales milestone payments.
Following the partnering of Cresemba with Pfizer, Basilea entered into a
distribution agreement with Cardiome Pharma Corp. for Zevtera for Europe
(excluding the Nordics) and Israel. Basilea also entered into a
distribution agreement with Avir Pharma Inc. for isavuconazole and
ceftobiprole for Canada in June and a license agreement with Shenzhen
China Resources Gosun Pharmaceutical Co., Ltd. for ceftobiprole for
China in September. Further distribution partnerships for both Cresemba
and Zevtera are in place for Latin America with Grupo Biotoscana S.L.,
the Nordics with Unimedic Pharma AB and the Middle East and North Africa
(MENA) region with Hikma Pharmaceuticals LLC.
Cresemba sales by our partner Astellas Pharma Inc. showed continued
strong growth in the second full year on the U.S. market. Astellas
reported sales of USD 77 million for the calendar year 2017, which is a
67% increase year-on-year. The strong sales performance in the U.S.
triggered a first sales milestone payment to Basilea of CHF 5 million in
2017.
In 2017, Pfizer launched Cresemba in Spain, and Unimedic launched
Cresemba and Zevtera in the Nordics. Overall, Basilea expects product
sales to grow significantly over the coming years based on both the
growing demand in existing markets and contributions from new markets as
the drugs gain regulatory approvals and are launched in additional
countries.
In Japan, license partner Asahi Kasei Pharma Corporation is conducting
an abbreviated clinical development program for isavuconazole to support
a potential registration. Asahi Kasei Pharma successfully completed a
phase 1 study in healthy volunteers and intends to start a phase 3
clinical study in the first half of 2018.
Working towards accessing the U.S. antibiotics market with increased
BARDA funding for the development of ceftobiprole
The U.S. market is an estimated 70% of the global market for branded
hospital antibiotics based on value(1) and therefore plays an important
role in Basilea's strategy for ceftobiprole. In 2017 Basilea agreed on
Special Protocol Assessments (SPAs) with the U.S. Food and Drug
Administration (FDA) for two cross-supportive clinical phase 3 studies
to support a potential regulatory filing in the U.S.: one in acute
bacterial skin and skin structure infections (ABSSSI) and a second in
Staphylococcus aureus bacteremia (SAB). In 2017, ceftobiprole also
received Qualified Infectious Disease Product (QIDP) designation from
the FDA for the treatment of SAB, adding to its QIDP designation for
ABSSSI and community-acquired pneumonia. QIDP status extends the market
exclusivity in the U.S. to ten years after approval.
Following the agreement of the SPAs with the FDA, the Biomedical
Advanced Research and Development Authority (BARDA) allocated a second
tranche of USD 58 million in June 2017 to support Basilea's clinical
phase 3 program under BARDA's existing contract with Basilea.(2) BARDA
allocated a first tranche of approximately USD 20 million in 2016. The
total value of the BARDA contract could reach approximately USD 108
million if pre-defined milestones are met. In 2017, Basilea received
reimbursements from BARDA of CHF 10.5 million. The ABSSSI study has
started and Basilea anticipates commencing patient enrollment in the SAB
study by mid-2018.
Expanding clinical testing of tumor checkpoint controller BAL101553 into
brain cancer
Significant progress has also been achieved in the clinical-stage
oncology projects. Basilea entered into a clinical study collaboration
with the Adult Brain Tumor Consortium (ABTC), which is funded by the
U.S. National Cancer Institute. A phase 1 study with tumor checkpoint
controller BAL101553 in combination with radiotherapy in patients with
newly diagnosed glioblastoma who have a reduced sensitivity to standard
chemotherapy was started at the end of 2017. In addition, Basilea is
also exploring BAL101553 as once-daily oral administration in patients
with recurrent or progressive glioblastoma in a separate arm of the
ongoing phase 1/2a study. Glioblastoma is the most common and aggressive
form of primary malignant brain tumor and is an area of high medical
need where very few treatment options are currently available.
In 2017, Basilea completed the phase 1 dose-escalation and established
the clinical dose ranges for BAL101553 in two clinical phase 1/2a
studies in patients with advanced solid tumors with daily oral
administration and weekly 48-hour intravenous (i.v.) infusion,
respectively. Basilea plans to initiate a phase 2a expansion with weekly
48-hour i.v. infusion in patients with recurrent glioblastoma and
ovarian cancer.
BAL3833: potential first-in-class cancer therapy in phase 1 clinical
testing
The oral dosage form of BAL3833 is currently being investigated by
Basilea's partner and licensor of the drug candidate, the Institute of
Cancer Research, in a clinical phase 1 dose-escalation study in patients
with solid tumors including metastatic melanoma. The study is being
sponsored by The Royal Marsden NHS Foundation Trust. BAL3833 blocks BRAF
and CRAF and also inhibits the SRC kinase family, which play an
important role in the transmission of cell growth and proliferation
signals. If deregulated, they are associated with tumor growth and the
development of resistance to current therapies. BAL3833 is to Basilea's
knowledge the only panRAF/SRC kinase inhibitor in clinical testing.
Focus on growing revenue and expanding pipeline
CEO Ronald Scott stated: "We are focused on further growing revenue from
our marketed drugs Cresemba and Zevtera. We expect our partners to
launch in additional countries in Europe and other parts of the world in
2018, driving sustainable top-line growth. We are expanding our clinical
programs in oncology and we have initiated patient recruitment in our
ceftobiprole phase 3 program with the goal to enter the U.S. market upon
regulatory approval. We are actively exploring opportunities to further
strengthen our pipeline in our focus areas of anti-infectives and
oncology through internal and external innovation."
Key figures
(In CHF million, except per share data) 2017 2016
Product revenue 16.3 7.1
Contract revenue 74.0 57.7
Revenue from R&D services 0.3 0.2
Other revenue 10.8 0.9
Total revenue 101.5 66.0
Costs of products sold (9.0) (5.3)
Research & development expenses, net (53.5) (48.4)
Selling, general & administration expenses (53.1) (56.1)
Total cost and operating expenses (115.7) (109.9)
Operating loss (14.1) (43.9)
Net loss (19.4) (51.3)
Net cash provided by/ (used for) operating activities 19.0 (75.0)
(MORE TO FOLLOW) Dow Jones Newswires
February 27, 2018 01:15 ET (06:15 GMT)
