Unilife Medical Solutions Limited (Unilife or the Company) (ASX:
UNI) (PINKSHEETS: UNIFF) today announced the signing of agreements
for the construction of its new global headquarters and commercial
production facility in York, Pennsylvania. The world-class medical
device production facility (New Facility) will be situated at 250
Cross Farm Lane in York and the 165,000 square foot development is
projected to be ready for operations by late 2010
As previously announced, the Company has been exploring a number
of potential opportunities with respect to the development of a new
global headquarters and manufacturing facility for the Unilife
Group in Pennsylvania in order to accommodate the Company's
projected pharmaceutical demand for its Unifill(TM) range of
ready-to-fill (prefilled) retractable syringes. The Company has now
decided, after carefully considering the advantages and
disadvantages (including from a financial and operational
perspective) of leasing and retrofitting an existing logistics
warehouse facility or developing its own custom built facility, to
proceed with the development of its own custom-built facility.
The New Facility will be developed on a 38 acre parcel of
industrial land with an expected total project cost of US$26
million, which will be funded by a combination of debt and cash
reserves. The land was purchased by Unilife Cross Farm, LLC
(Unilife CF), a subsidiary of Unilife Corporation, for
US$1,990,725.
Stage one of the New Facility is designed to accommodate
Unifill(TM) automated assembly lines with a combined annual
capacity of 360 million units per year, as well as the Unitract(TM)
1mL automated assembly line and other contract manufacturing
systems currently situated at Unilife's Lewisberry facility. It
will also include a 54,000 square foot office section that will
function as Unilife's global headquarters and support
administrative, marketing, new product development, quality
laboratories and other operational functions of the Company.
The New Facility has been designed to allow for an additional
100,000 square feet of contiguous production space to be readily
constructed at a later date by the Unilife Group. Upon this
additional expansion occurring, it will provide the Unilife Group
with the necessary space to produce up to one billion syringes per
annum via installation of additional Unifill(TM) assembly lines.
Although this additional expansion of the New Facility forms part
of the current planning approvals that have been received by the
Unilife Group, it is not part of the current development activity
and it is not covered or included in the current contracts that
have been entered into in respect of the New Facility.
While the potential development of a new manufacturing facility
was referred to in the Information Memorandum dated 27 November
2009 (sent to shareholders and optionholders in relation to the
proposed transaction to redomicile the Unilife Group in the US), as
a result of the commitment now being made by the Company to proceed
with the development of the New Facility and to enter into
construction and related contracts, a Supplementary Information
Memorandum explaining the development of the New Facility will
shortly be despatched to shareholders and optionholders of the
Company in accordance with relevant legal requirements.
Design and Functionality of New Facility
The New Facility has been custom-designed to meet Unilife's
requirements by L2 Architecture (L2), a Philadelphia-based
architectural and engineering design firm that specializes in the
pharmaceutical and medical device sector and which has some of the
leading global companies in that sector as its clients. The design
created by L2 incorporates the latest innovations in personnel and
material flow dynamics to maximize the industrial productivity of
the site while adhering to the highest standards in good
manufacturing practices.
Development of New Facility and Development Costs
Unilife CF has appointed Keystone Redevelopment Group LLC
(Keystone) to manage the development of the New Facility, and HSC
Builders and Constructions Managers (HSC) to undertake the
construction of the New Facility. Keystone is a Pennsylvania based
real estate company specialising in large scale redevelopment and
complex economic development projects. Clients of Keystone have
included a number of Fortune 500 companies. HSC is a
Pennsylvania-based company that specialises in building
custom-designed facilities for biotech, academic, healthcare,
pharmaceutical and technology companies. Its clients include some
of the largest pharmaceutical and healthcare companies in the
world.
Under the Development Agreement entered into between Unilife CF
and Keystone for the development of the New Facility, Keystone
will, in return for a US$754,000 development fee to be paid over
four tranches spanning the course of the project, work with Unilife
to obtain favourable public and private financing, and assist in
securing all necessary approvals, licenses, permits and
certificates from government authorities.
Under the construction contract with HSC, Unilife CF is required
to pay for the cost of construction (as defined in the construction
contract) (Cost of Work), together with HSC's fee, subject to a
Guaranteed Maximum Price (GMP) as described below.
HSC's fee for constructing the New Facility will be an amount
equal to 1.25% of the Cost of Work (HSC Fee). The GMP has been
established at US$21,700,000 (comprising HSC's fee and the Cost of
Work). Except for certain items beyond the control of Unilife CF or
HSC, or items changed at the option of Unilife CF, any construction
costs which exceed the Cost of Work will be the responsibility and
liability of HSC. Unilife CF has also agreed to pay HSC a
performance bonus of 15% of the HSC Fee if it achieves completion
of the utility rooms for equipment installation at the New Facility
by 15 April 2010 and another 15% of the HSC Fee as a bonus if it
achieves Phase 2 (see below) of the construction by 10 December
2010.
L2's fee for the agreed architectural services it will be
providing to the Company in respect of the project will be US$1.56
million.
Key Development Timelines
To support the scheduled completion of the Unifill(TM) syringe
industrialisation program in late 2010, Unilife has fast-tracked
the development of the New Facility with the aim of having it ready
in time to receive the first Unifill(TM) assembly line currently
being developed by Mikron. Initial site work for the New Facility
has been commenced with the footings and concrete being poured this
month.
The projected timetable for the construction of the New Facility
to be undertaken by HSC is as follows:
-- By the end of October 2010 Completion of clean rooms for equipment
installation (Phase 1)
-- By the end of October 2010 Temporary occupancy permit for
manufacturing/warehouse
-- By the end of December 2010 Unrestricted occupancy permit for
manufacturing/warehouse (Phase 2)
-- By the end of December 2010 Unrestricted occupancy permit for office.
Unilife is currently projecting that it will progressively
transfer and ultimately consolidate all of its US-based staff and
production systems from its current Lewisberry facilities into the
New Facility in early 2011. The New Facility is located
approximately 9 kilometres from the Lewisberry facilities.
Financing of the New Facility
Unilife intends to fund up to US$9 million of the development
costs of the New Facility out of existing cash reserves and will
seek external financing for up to a further US$17 million from a
commercial bank or other lending institution in the US as well as
from the Commonwealth of Pennsylvania and other US federal and
state bodies.
As at the date of this announcement, the Company is in
discussions with a number of banks, government agencies and other
interested parties in the US with respect to the required financing
for the New Facility. The Company has received term sheets from two
US banks and the current indications are that the Company will
receive financing terms that it considers appropriate and
favourable within the timeframe required. The Company will select
the party or parties to provide the financing after a careful
review of the proposed financing terms and other factors such as
the relevant party's financial strength.
Compared to original quotations to lease and internally retrofit
a suitable logistics site, Unilife estimates that it will save
approximately US$2 to $3 million in upfront development costs to
develop its custom-built New Facility. In addition, Unilife
estimates that loan repayments for the New Facility will be
approximately US$400,000 per year less than equivalent annual lease
commitments.
Statement from Unilife CEO Alan Shortall
"Unilife is committed to becoming a global leader in the
fast-growing pharmaceutical market for prefilled syringes. Given
the competitive advantages of our Unifill(TM) ready-to-fill
syringes, the current status of our industrialisation program and
the strong relationships we are building with pharmaceutical
customers, it is essential that we have the operational capability
to support significant levels of market demand. Given the level of
this pharmaceutical interest and our desire to stay ahead of
schedule in the industrialisation of the Unifill(TM) syringe, we
are now fast-tracking the development of a new facility.
"Our new global headquarters and production facility that is now
being developed in York, Pennsylvania will give us the required
flexibility to rapidly expand our business as we move towards a
NASDAQ listing, commercial production and the signing of supply
agreements with current and future pharmaceutical customers.
"This world-class facility now under construction has been
custom-designed to meet the highest standards of the international
pharmaceutical industry. The operational efficiencies and material
flow dynamics that have been incorporated into the design of this
facility will facilitate the production of our products to the
highest quality standards. This will enhance our industry
credentials and our position to become a reliable and trusted
supply partner to global pharmaceutical leaders.
"The development of our own custom-built facility makes sound,
financial, operational and logistical sense for Unilife. By
comparison, a leased warehouse site would have required a
significant investment to internally retrofit the building to meet
our specific operational requirements, and would have been
substantially more expensive for annual lease payments. We are
pleased with the strong interest this project has received from
private financing groups as well as Federal, Commonwealth and local
government agencies within the US. As a result, we are confident
that this US$26 million project will be financed in a way that best
meets the short and long-term interests of shareholders. This is
another indication of Unilife taking advantage of its strong market
position, preparing for its rapid business expansion, and building
long-term shareholder value."
Statement from Unilife Senior Vice-President of Operations
Bernhard Opitz
"Upon completion of stage one of the new facility, it will have
the capacity to support the production of 360 million units of our
proprietary syringes per annum. When we decide to proceed with the
100,000 square foot extension to the facility, we will then have
the ability to increase our production capacity to up to one
billion syringes per year.
"Unilife has aligned itself with respected US leaders in the
design and development of world-class pharmaceutical and medical
device facilities. These development partners for our new facility
are committed to its rapid construction so that the site is ready
to accept the scheduled delivery of the first commercial assembly
line for our Unifill(TM) syringes during the third quarter of
2010."
Statement from Keystone Manager Robert Ventresca
"As a result of the current economic slowdown, the US
construction industry has been hit especially hard. This dynamic in
the construction market puts Unilife in a very strong position to
build its new facility at this time. Recent trends indicate
construction costs are as much as 25% to 30% below equivalent price
levels from two years ago.
"With a corresponding slowdown in the financial markets, lending
institutions, while remaining very cautious, also still need to
originate new loans and are doing so very selectively. Unilife is
in a strong position to take advantage of the current environment
and secure a competitive financing package for the construction of
its new facility with high quality developers that will leverage an
optimal blending of private bank financing with Federal, State and
local financial incentives."
Correction of Information Memorandum despatch date
It was stated in the announcement made by the Company on 10
December 2009 that the Information Memorandum in respect of the
proposed transaction to redomicilie the Unilife Group in the US had
been despatched to shareholders and optionholders of the Company on
that date. However, the Company would like to confirm that despatch
of the Information Memorandum to shareholders and optionholders
actually occurred on 11 December 2009, rather than 10 December 2009
as stated in the initial announcement.
About Unilife
Unilife Medical Solutions Ltd is an ISO 13485 certified company
that designs, develops and supplies innovative safety medical
devices. Listed on the Australian Securities Exchange (ASX: UNI)
since 2002, Unilife has FDA-registered manufacturing facilities in
the US State of Pennsylvania and a proprietary portfolio of
clinical and prefilled safety syringes designed for use within
healthcare and pharmaceutical markets.
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