TIDMABZA
RNS Number : 3797X
Abzena PLC
21 February 2017
Abzena plc
Trading and business update
Cambridge, UK, 21 February 2017 - Abzena plc (AIM: ABZA,
'Abzena' or the 'Group'), a life sciences group providing services
and technologies enabling the development and manufacture of
biopharmaceutical products, provides the following business update
for the period to 20 February 2017.
Highlights
-- Group revenue for the full year expected to be in line with the Board's expectations.
-- UK business operated strongly, offsetting the lower than expected growth in the US operations.
-- Costs from enhancing the US businesses to support long-term growth, including the investment capex, are above the
Board's prior expectations when translated into Sterling, but position the business favourably for selling the
Group's integrated biopharmaceutical development services.
-- Expanded capacity in San Diego with two new biomanufacturing cleanroom suites operational and an additional
9,000sq.ft. facility to enable expansion of biomanufacturing process development group.
-- GMP capability for manufacture of ADC linker-payloads now operational at Bristol, PA facility.
-- New 'Abzena inside' product entered Phase I clinical development with an undisclosed, private US biotech company
- now 12 clinical stage products in 'Abzena inside' portfolio.
-- Two 'Abzena inside' products progressed into Phase II clinical development: Roche's RG6125 for rheumatoid
arthritis, and an undisclosed major US pharma programme for neurodegenerative conditions
-- Significant licence agreement for ThioBridge(TM) antibody drug conjugate (ADC) linker technology with San
Diego-based biopharmaceutical company announced on 20 January 2017.
-- Licence agreement for Composite Human Antibody(TM) technology signed with US biotech, Trieza Therapeutics
announced on 22 December 2016.
-- Manufacturing process development agreement with UCL for magacizumab, a candidate for neovascular age-related
macular degeneration, following prior antibody engineering and cell line development projects for this product
(see separate RNS Reach announcement today).
Dr John Burt, CEO of Abzena said:
"We are seeing good progress both within our services business
and across our 'Abzena inside' portfolio. This strong momentum in
top line growth from the first half has continued, driven by demand
for our integrated services across the breadth of the
biopharmaceutical development process.
"Our strategy of investing in future capacity will ensure our
ability to provide quality service for this high level of customer
need as our partners' programmes progress. We continue to explore
funding options to enable us to maintain this level of growth and
to continue to expand our biomanufacturing capacity and
capabilities."
Current trading
For the year to 31 March 2017, the Board expects to report
overall Group revenues in line with its expectations as the
momentum from the first half and strong demand for services has
continued.
The revenues generated by the UK businesses have remained
strong, offsetting the lower than expected growth of the revenue
from the US businesses. The Group has worked on repositioning and
enhancing these US businesses for further growth, which in turn has
led to increased costs ahead of further growth in revenues.
Due to the strong US dollar, when translated into Sterling,
these US costs and therefore Group costs overall, are ahead of the
Board's original expectations.
The aim of the US investment is to create a stronger, long-term
offering from Abzena overall for its customers. Customer reaction
to the enhanced offering through the improvements and investments
made to date has been positive.
Cash at the end of the financial year is expected to be in line
with the Board's expectations.
The Group expects to report its full year results in June
2017.
Business overview
The period was dominated by restructuring and expansion to
increase capacity in the US business, good progress within the UK
services business and 'Abzena inside' portfolio.
-- Capacity expansion
Demand for Abzena's expanded range of integrated services
continues to result in good customer engagement across the
business. Contract bookings are strong from both new and existing
customers as they benefit from using the full breadth of the
Group's offering. The high levels of utilisation seen in the first
half of the year have been sustained.
In response to the increased demand for its services, during the
second half of the year, Abzena has accelerated its investment in
growing both its manufacturing capacity and its biology R&D to
provide new and enhanced solutions for partners.
Further capacity expansion has been completed in San Diego, with
two new biomanufacturing cleanroom suites now fully operational.
Additional ancillary office space has been secured for Abzena's
growing biomanufacturing operations.
In addition, to fulfil the demand for the Group's process
development capabilities, Abzena has leased a further 9,000 sq.ft.
office and laboratory facility as part of its capacity-enhancing
investment programme.
In Bristol, PA, GMP capability for the manufacture of ADC
linker-payloads is now operational and the Group is now able to
manufacture linker-payload reagents for the its current and
prospective ThioBridge(TM) partners.
As disclosed at the half year results in November 2016, the
Group continues to explore options to fund the growth of the
manufacturing business through a significant expansion programme.
This includes upgrading the GMP manufacturing platform and
increasing capacity for process development and manufacturing.
Subject to funding, Abzena also plans to establish a GMP
conjugation facility in Bristol, PA, as part of the next phase of
its investment and growth plans.
-- 'Abzena inside' portfolio
The portfolio of 'Abzena inside' products has seen good progress
with a further Composite Human Antibody(TM) product being taken
into clinical development by a US biotech company. This takes the
number of 'Abzena inside' products at a clinical stage to 12.
Within the portfolio, 'Abzena inside' products are also
advancing through the clinic. Roche's RG6125 has progressed into
Phase II as a potential treatment for rheumatoid arthritis. A
second programme, on which(TM) Abzena has the potential to receive
a milestone payment based on future successful clinical
development, has been advanced by a major US pharma company into
two Phase II studies in patients with neurodegenerative
conditions.
-- Licence agreements
In January 2017, Abzena signed a significant licence agreement
for its novel, site-specific ThioBridge ADC linker technology with
an undisclosed San Diego-based biopharmaceutical company. The
agreement covers the use of ThioBridge(TM) in up to 10 ADCs across
a wide range of indications. The value of the agreement has the
potential to reach over $300 million in licence fees and milestone
payments over the medium term.
In December 2016, Abzena also signed a license agreement for its
Composite Human Antibody(TM) technology with US biotech, Trieza
Therapeutics for use in oncology. This agreement could result in up
to $35 million in development and commercial milestone payments as
well as royalties on the sale of licensed products containing the
Abzena sequence.
Certain information contained in this announcement would have
constituted inside information (as defined by Article 7 of
Regulation (EU) No 596/2014) prior to its release as part of this
announcement.
-Ends-
Enquiries:
Abzena plc
John Burt, Chief Executive
Officer Julian Smith, Chief
Financial Officer +44 1223 903498
Numis (Nominated Adviser and
Broker)
Clare Terlouw / James Black +44 20 7260
/ Paul Gillam 1000
N+1 Singer (Joint Broker) +44 20 7496
Aubrey Powell / Liz Yong 3000
Instinctif Partners +44 20 7457
Melanie Toyne Sewell / Rozi 2020
Morris abzena@instinctif.com
Notes to Editors
About Abzena
Abzena (AIM: ABZA) provides proprietary technologies and
complementary services to enable the development and manufacture of
biopharmaceutical products, a growing area that requires specialist
knowledge and expertise. The Group has a global customer base which
includes the majority of the top 20 biopharmaceutical companies as
well as large and small biotech companies and academic groups.
The term 'Abzena inside' is used by Abzena to describe products
that have been created using its proprietary technologies and are
being developed by its partners, and include Composite Human
Antibodies(TM) and ThioBridge(TM) Antibody Drug Conjugates (ADCs).
Abzena has the potential to earn future licence fees, milestone
payments and/or royalties on 'Abzena inside' products.
Abzena offers the following services and technologies across its
principal sites in Cambridge (UK), San Diego, California (USA) and
Bristol, Pennsylvania (USA):
-- Immunogenicity assessment, protein engineering to create humanized antibodies and deimmunised therapeutic
proteins, and cell line development for manufacture.
-- Contract process development and manufacture of biopharmaceuticals, including monoclonal antibodies, recombinant
proteins, vaccines, and gene therapy and cell therapy products, for preclinical and clinical studies.
-- Proprietary site-specific conjugation technologies for antibody drug conjugate development and solutions for
optimizing the therapeutic properties of biopharmaceuticals.
-- Contract chemistry and bioconjugation business focused on ADCs and is establishing the capability to manufacture
ADCs to GMP standards.
For more information, please see www.abzena.com
TSTGMGZZFGRGNZZ
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February 21, 2017 02:01 ET (07:01 GMT)
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