Posted by ProActive NewsRoom on Wed, Mar 03, 2010 @ 10:18 AM
Unilife Corp. (NASDAQ: UNIS) announced a therapeutic exclusivity agreement with Sanofi-Aventis (NYSE: SNY) today for rights to purchase Unilife's ready-to-fill safety syringe, Unifill, for use with blood thinners and vaccines. The pact lasts until 6/30/14 and will include a 10-year extension if SNY purchases commercial quantities of Unifill prior to 7/1/14.
Below is a link to the ProActive News Room website for Unilife, which includes an updated compilation of digital media coverage links for the Company, research reports, corporate presentations, news feeds, market data, and more.
http://www.proactivenewsroom.com/unilife/
Unilife is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices.
Posted by ProActive NewsRoom on Mon, Mar 01, 2010 @ 02:09 PM
Unilife Corp.'s (NASDAQ: UNIS) CEO Alan Shortall featured on TheStreet.com TV interview today at
http://www.thestreet.com/video/10691705/unilife-sticking-to-growth-plan.html#69177700001
Unilife is an emerging medical device manufacturer with business segments that include pre-filled syringes for pharmaceutical companies to deliver injectable medications, sharps safety devices for healthcare facilities, and contract manufacturing of medical devices. The Company recently relocated to the US in Central Pennsylvania and has a deal with Sanofi-Aventis (NYSE: SNY) to supply its Unifill safety, pre-filled syringes.
Below is a link to the ProActive News Room website for Unilife, which includes an updated compilation of digital media coverage links for the Company, research reports, corporate presentations, news feeds, market data, and more.
http://www.proactivenewsroom.com/unilife/
Posted by Mike Havrilla on Mon, Feb 22, 2010 @ 03:24 PM
Unilife Corp's (UNIS) CEO Alan Shortall Rings NASDAQ Stock Market Closing Bell on 22-Feb. 2010:
http://finance.yahoo.com/news/Unilife-Corporations-UNIS-pz-2438527210.html?x=0&.v=1
Unilife Corp. Donates First Shipment of Unitract Safety Syringes to Haitian Relief Efforts:
http://finance.yahoo.com/news/Unilife-Corporation-Donates-prnews-2387643445.html?x=0&.v=1
Disclosure: No positions
Posted by Mike Havrilla on Fri, Feb 12, 2010 @ 07:41 AM
Lewisberry, PA (February 12, 2010) Unilife Corporation (Company) (ASX: UNS, NASDAQ: UNIS) today announced that the US Securities and Exchange Commission (SEC) declared the Company's Form 10 registration statement effective, clearing the path for Unilife Corporation's listing on the NASDAQ.
The Company expects trading of Unilife Corporation common stock to commence on NASDAQ on or around February 16, 2010 under the ticker "UNIS".
Alan Shortall, CEO of Unilife, stated, "I would like to thank the Unilife team for the completion of this significant corporate milestone. In particular, I wish to note the important contribution made by the Unilife Finance department, and our Australian and US legal representatives, DLA Phillips Fox and DLA Piper who worked tirelessly to achieve this approval within our projected timeframe.
"Despite severe weather conditions in the eastern portion of the US that caused a shutdown of all Federal Government offices in Washington, DC, and restricted operations in both Pennsylvania and New York City, our team has been able to work co-operatively to complete the work necessary to achieve this result. I must compliment the Unilife team and our advisors for an outstanding effort."
The Company also wishes to advise that by the time trading of Unilife common stock commences on NASDAQ, it will have published on its website (http://www.unilife.com/) a list of Frequently Asked Questions (FAQs) to support shareholders wishing to trade on either the ASX or NASDAQ. The Company has also now opened an Investor Hotline to assist with shareholder enquiries during this period. The enquiry line numbers are 1800 632 680 (Australia toll free), +1 866 496 5819 (US toll free) and or +61 2 8256 3394 (International).
Posted by Mike Havrilla on Tue, Jan 12, 2010 @ 09:19 AM
During the second week of January, Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) shareholders overwhelmingly voted in favor of the Company's U.S. relocation. Unilife is now in the final stages of preparation for a NASDAQ: UNIS stock market trading debut, which is expected to occur by the end of February in conjunction with the Company's re-domiciliation to Central Pennsylvania. Unilife is emerging as a leading innovator in the medical device manufacturing space with a focus on safety syringes and business segments that include pre-filled syringes for pharmaceutical companies to deliver injected medications, sharps safety devices for healthcare facilities, and contract manufacturing services.
Unilife USA will replace Unilife Australia as the entity which is listed on the ASX. Unilife Australia shareholders will receive common stock or CHESS Depositary Interests (CDIs) in Unilife USA. The CDIs will trade on the ASX and are analogous to American Depository Receipts (ADRs), which represent ownership stakes in foreign companies that trade on U.S. financial exchanges. Unilife USA will trade on the NASDAQ with ticker ‘UNIS' and six CDIs will be equivalent to one ordinary share in Unilife USA.
Last December, Unilife announced the construction of a 165,000 square foot development that will house the Company's new global headquarters and a commercial production facility at 250 Cross Farm Lane in York, PA. The new facility will also include a 54,000 square foot office space for administrative, marketing, research / development, and quality control. The first stage of the new manufacturing facility will include automated assembly lines with annual capacity of 360 million units per year for Unifill, in addition to other assembly lines for Unitract 1mL safety syringes and other medical device contract manufacturing systems. There is a built-in option and strategy to allow for future expansion, including an additional 100,000 square foot in connected production space that would provide Unifill manufacturing capacity of 1 billion syringes per year.
The new facility is expected to be operational by late 2010 and is being developed on a 38 acre parcel of land at a projected cost of $26 million, which included favorable terms for Unilife in terms of acquiring the land and the project development / contractor expense because of the overall economic conditions in the region which make this situation a buyer's market (construction costs are down an estimated 25-30% from two years ago). However, Unilife has contracted with Keystone Redevelopment Group and HSC Builders and Constructions Managers, which are top tier organizations that serve Fortune 500 companies for economic development projects and specialize in the construction of customized facilities for leading life science / healthcare companies, respectively. The projected timeline for construction of the new facility includes the following milestones:
1.) the completion of clean rooms for equipment installation and a temporary occupancy permit for manufacturing / warehouse by the end of October 2010;
2.) an unrestricted occupancy permits for manufacturing / warehouse and office space by the end of December 2010;
3.) transfer and consolidation of all US-based staff / manufacturing systems from Lewisberry facilities (approximately five miles apart) beginning in early 2011.
In addition, the centralization of production activities within Central PA will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply its safety syringes to all of its anticipated customers while leveraging upon the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs. In late October, Unilife announced the acceptance of a US$5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County as part of the Company's relocation of its global headquarters and manufacturing facilities to Central PA.
Unilife plans to finance development of the new facility from a combination of existing cash reserves ($9 million) and external financing ($17 million), which may include a commercial bank loan, government agencies, and / or other lending institutions. The Company estimates that it saved $2-3 million in upfront development costs and will save approximately $400,000 annually in estimated loan financing payments for the new facility compared to lease payments at the current facility. The following are some key milestones that Unilife expects to achieve during 2010:
1.) the commercial release of Unitract 1mL plastic safety syringes in early 2010;
2.) complete negotiations with Sanofi-Aventis (NYSE: SNY) by end of February for Unifill therapeutic class exclusivity;
3.) subject to the SEC declaring registration statement effective and NASDAQ approval for listing application, Unilife expects NASDAQ: UNIS trading to begin in mid-February
4.) complete the Unifill industrialization program by the end of 2010 (one year ahead of original plan) with initial production goal of 60 million units per year and a projected increases to approximately 150 million units annually by 2012; and
5.) agreement(s) are possible as early as mid-2010 with additional pharmaceutical companies for Unifill pre-filled syringes outside of the exclusive therapeutic categories that are pending final negotiations with SNY.
More than 2 billion prefilled syringes are currently used each year on a global basis and pharmaceutical companies are making the switch to products such as Unilife's safety syringe which are compliant with needle-stick prevention laws (e.g. Federal Needlestick Prevention Act, 2000) in the U.S. (enforced by OSHA) with Europe expected to follow with similar regulations by 2012 based on the model that is currently enforced in Germany. The Unitract product line-up includes plastic safety syringes as 1mL fixed-needle + 3mL and 5mL attachable needles while the Unifill product line-up includes a glass ready-to-fill solution with both fixed needle and attachable options for medications delivered by pre-filled syringes.
A strong resistance to change and high barrier to entry exists for competitors in the medical device / safety syringe market because once supply contracts are agreed upon and products receive marketing clearance; there is little incentive to change components (e.g. a pre-filled syringe) since this would require a new approval process to certify the new components being utilized.
The unique features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes are outlined below and the Company has a major advantage and pending customer in the form of SNY along with a strategic plan that targets companies with new products in development that are designed for delivery through pre-filled syringes.
1.) a passive needle retraction system that is activated inside the body
2.) healthcare providers / shot administrators control the speed of needle retraction
3.) auto-disabling prevents the re-use or tampering of used syringes
The market opportunity for prefilled syringes includes over 50 medications (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including a projected 3 billion prefilled syringes in use by 2012. Unilife has a distinct advantage with a disruptive technology since there are currently no prefilled syringes to deliver medications with fully-integrated safety features so pharmaceutical companies must add these features, adding to the manufacturing and shipping costs while significantly increasing the overall packaging size (i.e. Unifill reduces packaging volume for drug products by 60% without the need for ancillary safety instruments that must be attached / assembled as with standard prefilled syringes), resulting in both waste disposal and marketing issues.
The key strategic business partner for Unilife is Sanofi-Aventis, which is the largest buyer of pre-filled syringes in the world for injectable products such as the blood thinner Lovenox and influenza vaccines such as Fluzone marketed by the Company (Griffin Securities estimates that SNY purchases 40% of all pre-filled syringes on a global basis). This key partnership provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of initial commercial demand for Unifill in 2011 with an initial production target of 60 million units per year.
In July, Unilife and SNY agreed to a five-year exclusive licensing agreement for Unifill. SNY is paying A$46M for the right to negotiate purchase of the Unifill RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class. While the therapeutic exclusivity agreement (expected by February) will not be disclosed to the public to protect Sanofi's R&D pipeline; blood thinners and vaccines are two major product segments for SNY that are obvious inclusions and agreements that are announced with other companies will provide this information over time.
The industrialization program was originally intended to be completed by the end of 2011, but it is proceeding ahead of schedule so that both parties have agreed to bring its scheduled completion date forward to the end of 2010 (an entire year ahead of schedule). Unilife is scheduled to commence supply of Unifill RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system, and the design of this first line will also be used to develop a higher-volume automated assembly system scheduled to be completed by the end of 2011.
Given the current foreign exchange ratio for the Australian / U.S. dollar, a share price of $1 for the ASX stock listing ‘UNI' would correspond to roughly $5.50 per share for Unilife USA when it begins trading on the NASDAQ. The share price above $5 and NASDAQ listing will be key elements to increasing the Company's U.S. shareholder base and attracting institutional investors. In addition, the strong commitment to building a new facility in Central PA and over-delivering on strategic objectives adds to the bullish case for Unilife in 2010 and beyond.
Click here for the ProActive News Room website for Unilife, which includes an updated compilation of digital media coverage links for the Company such as a recent CNBC video interview with CEO Alan Shortall, research reports (including an update report published yesterday by Crystal Research Associates), corporate presentations, news feeds, market data, and more.
Disclosure: No positions
Posted by Mike Havrilla on Tue, Dec 15, 2009 @ 07:51 PM
Unilife Commences Development of New Global Headquarters and Commercial Production Facility in Pennsylvania
World Class Custom-Designed Facility to have First-Stage Manufacturing Capacity of up to 360 million Syringes Annually
First Stage Scheduled for Completion in late 2010
Unilife Medical Solutions Limited (Unilife or the Company) (ASX: UNI / OTCPK: 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 UnifillTM 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 UnifillTM automated assembly lines with a combined annual capacity of 360 million units per year, as well as the UnitractTM 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 UnifillTM 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 UnifillTM 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 UnifillTM 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 USbased 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 custombuilt 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 UnifillTM 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 UnifillTM 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 UnifillTM 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. "
Posted by Mike Havrilla on Fri, Oct 30, 2009 @ 02:32 PM
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Posted by Mike Havrilla on Thu, Oct 22, 2009 @ 07:18 PM
Lewisberry, P.A. (October 23, 2009) Unilife Medical Solutions Limited ("Unilife" or "the Company") (ASX: UNI / OTCPK: UNIFF) today announced that its Chief Executive Officer Alan Shortall has made open market purchases of Company shares.
The total number of shares purchased on October 21st, 2009 was 479,800 at an average price of A$1.026 per share. Mr. Shortall has authorized his broker to purchase additional shares that will bring the total number of shares purchased this week to in excess of 500,000 shares.
Mr. Shortall said that he has elected to purchase these shares in the open market rather than participate in the recently announced private placement.
"The reason I chose to purchase these shares via the open market was to show our shareholders that I am standing by them in their belief in the Company," Mr Shortall said.
"I could have simply participated in the private placement and obtained the shares at a discount to market and received the benefit of the same options that the institutions received, but I have instead chosen to show my allegiance to the Company and its shareholders by purchasing additional shares in the open market. I believe a direct market purchase is a truer reflection of my genuine support for our Company and my confidence in our long term prospects and world-class management team."
In considering his investment Mr. Shortall continued, "The progress the Company has made during the last two years, and our recent closing of the A$32.1 million private placement to institutional investors, provides me with the confidence to state that despite current economic conditions, I believe that Unilife has never been in a better position, operationally or financially.