UNI - Unilife Medical Solutions

Unilife granted $5.6m funding from Pennsylvania

Source: News Bites


Unilife Medical Solutions Ltd has accepted a $5.6 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County.

The funds will be used to support Unilife’s establishment in the design, development and supply of innovative safety medical devices for use within US and international pharmaceutical and healthcare markets.

The offer includes access to the following programs:

- An award of $2.17 million for the development of a new facility in South-Central Pennsylvania;

- Up to $2.17 million in low-interest financing loans for land and building acquisition and construction costs from the Pennsylvania Industrial Development Authority;

- A $542,000 opportunity grant, which may be used for any eligible costs associated with a company project;

- $522,000 in job creation tax credits for the creation of 241 highly-skilled jobs by 2013; and

- $216,000 in customised job training grants, which reimburse 75% of eligible costs associated with advanced level training for new or existing employees.

Unilife CEO Alan Shortall said the funding program would help defray the initial costs and cash outlays required for the acquisition of the new facility and the automated production lines necessary to manufacture Unilife’s products.

Unilife Medical Solutions CEO acquires more shares
Friday, October 23, 2009

International medical device company Unilife Medical Solutions (ASX: UNI; OTCPK: UNIFF) has reported that
chief executive officer Alan Shortall has acquired additional shares in the company on-market.

Total shares purchased this week by Alan Shortall were in excess of 500,000 shares at an average price of $1.026 per share.

Current Unilife share price is $1.10, up 2.5 cents today.

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," he said.

Recently, the company closed a A$32.1 million private placement to institutional investors.

On September 1 2009, Unilife Medical Solutions Limited entered into a merger agreement with Unilife Corporation (Unilife USA), a wholly owned subsidiary of Unilife Australia. The purpose of the Merger is to move the domicile of the Unilife group to the United States of America.

A listing on NASDAQ will be sought after implementation of the merger.

Unilife (UNIFF.PK): Medical Device Innovator Creating Jobs in PA
Posted by Mike Havrilla on Thu, Oct 29, 2009 @ 05:01 PM

Unilife Medical Solutions (ASX: UNI.AX) (OTC: UNIFF.PK) 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.

More than two 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). Key differentiating features of Unilife's fully-integrated (within the barrel of the syringe) safety syringes include the following:

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 re-use or tampering with used syringes

The market opportunity for prefilled syringes includes 50 drugs (primary anti-coagulant / hematology medications, vaccines, and other biological agents) that are delivered by injection, including an estimated 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 - which adds to production / shipping costs and increases the overall packaging size by up to 60%, resulting in both waste disposal and marketing issues.

In mid-August, Unilife announced that it has commenced U.S. production of the UnitractTM 1mL Insulin Syringe at its FDA-registered manufacturing facility in Pennsylvania. The Company's automated assembly system is now rated at up to 90% of efficiency and Unilife will continue to work towards achieving the optimum productivity rate for this assembly system of about 40 million units per year. Unilife will now begin to build inventory to fulfill current and anticipated orders for its Unitract 1mL Syringes, which has already received key regulatory certifications for use in major markets such as the U.S. (FDA), Canada, Europe (CE Mark), and Australia.

Commercial release of the Unitract 1mL Syringes is expected to occur during 4Q09 once product aging studies have been completed and Unilife will promote the products at key industry events in the U.S. and Europe. Unilife is currently in discussions with a number of global pharmaceutical and healthcare companies that are interested in the Unitract 1mL Syringes. The Company also recently announced a pair of upcoming presentations at pharmaceutical trade shows in Europe to showcase its safety syringe technology and products.

The Company's strategic partner for exclusive manufacturing and distribution of sharps safety products is Shanghai Kindly Enterprise Development Group (KDL). This facility currently produces Unitract 1mL syringes and MedPro blood collection safety devices using semi-automated assembly systems developed and qualified by Unilife. KDL is the second largest medical device manufacturer in China and has two-thirds market share of the Chinese needle market, manufacturing over 5 billion needles and 600 million syringes per year. In addition, Unilife has a development agreement with PA-based West Pharmaceutical Services (NYSE:WST) for the provision of specialist components such as seals for Unitract products.

The key strategic business partner for Unilife is Sanofi-Aventis (NYSE:SNY), 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). Last July, Unilife and SNY agreed to a five-year exclusive licensing agreement for the Unilife Pre-Filled syringe. SNY is paying US$38M for the right to negotiate purchase of the RTFS (ready-to-fill syringe), consisting of fees and milestone-based industrialization payments with ongoing negotiations for exclusivity agreements by therapeutic class (e.g. blood thinners, vaccines, etc.).

The industrialization agreement with SNY for Unilife Ready-to-Fill Syringe (RTFS) announced mid-year allows Unilife to move forward with discussions that include other potential customers that are interested in the Company's prefilled syringes (with an additional agreement expected in early 2010). This key partnership with SNY provides Unilife with the necessary capital to expand its U.S. manufacturing capacity and will provide a major source of demand for the Company's pre-filled syringes by late 2010 with a production target of 40 million units per year at that time.

The 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 the RTFS by the end of 2010. Initial supply of the RTFS by Unilife will utilize a fully automated assembly system that will have a targeted annual capacity of more than 40 million units. 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.

This high-volume automated assembly system is anticipated to have an annual production capacity greater than 100 million units and Unilife has a target production plan for the RTFS of about 400 million units per year beyond 2014. In addition, the centralization of RTFS production activities within Central PA is expected to occur in 2010 and will reduce the Company's operational costs, further optimize its supply chain activities, and place Unilife in a more favorable international location to supply the RTFS to all of its anticipated customers while leveraging the Company's strong, mutually beneficial relationship with the PA government due to the generation of high quality jobs in the state.

Earlier this week, Unilife announced this week that it has accepted a $5.2 million offer of assistance from the Commonwealth of Pennsylvania to support the creation of 241 new jobs within York County. The Company's expansion plans in Central PA include the proposed redomiciliation from Australia to the U.S., obtaining a NASDAQ listing for the stock, and the establishment of a major new global headquarters + manufacturing facility.

continued below:

Unilife also announced this week that it has commenced the filing of international trademarks for UnifillTM, which will become the market brand for its portfolio of ready-to-fill safety syringes. The product previously referred to on a pre-commercial basis as the Unilife Ready-to-Fill Syringe (or Unilife Prefilled Syringe) will now be marketed as the Unifill syringe. Unilife has developed the Unifill brand to help the Company effectively market its expanding range of injectable drug delivery products designed for use by pharmaceutical companies.

Last week, Unilife announced that CEO Alan Shortall 479,800 shares of the Company's stock on the open market at an average price of A$1.026 per share and the CEO has authorized his broker to purchase additional shares that will bring the total number of shares purchased to over 500,000. Mr. Shortall commented that he elected to purchase the shares in the open market rather than participate in the Company's recently announced private placement (conducted at a 7.7% discount to the market price at the time) as a sign of confidence to shareholders

In early October, Unilife announced an A$42.1M capital raise (consisting of an A$32.1M private placement to institutional investors + A$10M fully underwritten share purchase plan to existing, eligible shareholders at the same price of A$0.85 per share) to accelerate the expansion of its operational capabilities, production facilities, and equipment requirements in the U.S., in addition to completing the industrialization of the Unilife Ready-to-Fill Syringe. Unilife also plans to expedite the commercialization of additional pipeline products with other interested major pharmaceutical companies with whom the Company is currently in discussions. Finally, the proceeds of the capital raise will ensure adequate cash reserves leading to the redomiciliation in the U.S. and planned NASDAQ listing for the stock.

The Company announced that it received significant interest in recent months from both U.S. / Australian investors and other industry stakeholders for its strategic and operational strategies and the Board determined that it was in the best interests of shareholders to act upon this strong interest prior to its anticipated NASDAQ listing to ensure the Company has sufficient cash reserves to support and accelerate significant business expansion activities which it expects to undertake within the United States.

Since I first wrote about Unilife in early April, the US-listed Pink Sheet ADR (UNIFF.PK) has experienced an exponential rise in both share price (from below 25 cents to the one dollar range) and trading volume as investors recognize the significant potential of the Company's niche strategy focused on safety syringes. The bullish sentiment by investors for Unilife is warranted given its disruptive safety syringe technology, relocation plans to the U.S. / NASDAQ stock listing next year, partnership with Sanofi, recent capital raise, and an additional deal expected next year.

Click here for the ProActive News Room landing page for Unilife, which includes a compilation of digital media coverage links for the Company and several recent reports and presentations, including those outlined below.

Unilife Medical (OTC: UNIFF.PK): Griffin Securities 8/19/09

Unilife Medical (OTC: UNIFF.PK): Sept. 2009 Presentation

Unilife Medical (OTC: UNIFF.PK): CCZ Equities 10/13/09

75% allocations. Not bad at all. Surprising only 30% of holders took it up lol.
Gotta be thankful though

skyQuake said:

75% allocations. Not bad at all. Surprising only 30% of holders took it up lol.
Gotta be thankful though

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I am more than happy with 75% was hoping for 50%. I was also surprised that only 30% of holders took up the offer perhaps 30% don't have an AUS/NZ address and the other 30% don't have the cash, bad luck for them. Concidering it was only 30% of holders they raised triple what they were after. Looking good now and in to the future. Good luck holders!

UNILIFE RECEIVES A$28.7 MILLION IN SPP APPLICATIONS
All participating shareholders to receive 75% of their initial application
A total of A$21.5 million to be accepted under this Unilife SPP

Unilife Medical Solutions Limited (ASX:UNI/OTCPK:UNIFF),(Unilife or the Company) is pleased to announce that its 2009 Share Purchase Plan (SPP), which closed on Friday, 30 October 2009, was significantly oversubscribed with applications for approximately 33.7 million new, fully paid ordinary shares (SPP Shares) with a value of approximately A$28.7 million. As a result of the overwhelming demand for Shares under the SPP, the Board has authorised an
increase in the number of Shares to be issued under the SPP from 11,764,705 Shares to raise $10 million to approximately 25.3 million Shares, to raise approximately A$21.5 million before costs, representing a pro-rata allotment to all shareholders of 75% of their application.

As announced on 7 October 2009, Unilife offered eligible shareholders with a registered address in Australia or New Zealand the opportunity to subscribe for up to $15,000 worth of Shares under the SPP. In accordance with ASIC Class Order 09/425, applications by individual shareholders for more than A$15,000 worth of Shares have been rejected and, as a result of the over-subscription, the Company will scale back other applications, such that each applicant will receive 75% of their initial application for Shares under the SPP. Unilife will refund any excess application remittances to shareholders (without interest) shortly following allotment of the SPP Shares which is now due to
occur on 17 November 2009.

In addition to the receipt of commitments for A$32.1 million from institutional investors in the US and sophisticated and professional investors in Australia, the Board decision to increase the amount to be accepted under the SPP to A$21.5 million has resulted in the total sum committed amounting to A$53.6 million. The additional funds accepted under this SPP will further help Unilife accelerate the continued expansion of its business activities within the United States and other international markets. In particular, the Board expects that these additional funds will assist the Company with the development of its new global headquarters and production facility to be established in Central Pennsylvania, and fast-track the development of production systems that will support anticipated pharmaceutical market demand for its range of Unifill syringes.

Comment from Unilife Chief Executive Officer, Mr Alan Shortall
“The Board and I are very pleased by the overwhelming support displayed by the shareholders applying for shares in the SPP. We received applications from over 30% of Unilife’s shareholders for almost 200% more money than we intended to raise."

“The Board recognises the importance and support that individual shareholders have provided to Unilife during the past eight years, and the on-going support they are again showing for the Company and its management through these applications."

“The Board wishes to accommodate the shareholders to the greatest extent possible. However, we have conducted a further careful evaluation of our cash requirements for the foreseeable future, and as a result of this review, we simply cannot accept more than 75% of the applied for amounts, and adequately deploy those funds during this period in a productive manner. On behalf of the Board, I would like to express our sincere thanks to all of our shareholders for their trust and support.”

Timing and allotment
Allotment of Shares under the SPP will occur on 17 November 2009. Applicants will be advised of their final allocations when holding statements in respect of the SPP Shares are despatched, which is expected to occur on 23 November 2009. It is the responsibility of shareholders to confirm the number of Shares allotted to them under the SPP prior to trading in those Shares. Shareholders who sell SPP Shares before they receive their holding statements do so at their own risk.

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Hi Guys, I own shares in UNI and was thinking of loading up while they seem to be holding at $1.00. I am looking to hold for 2-4 yrs. With the griffin analysts predicting it to reach $3.60 I think you can't go wrong.
I was wondering if anyone else who owns shares in UNI believe $4 is achievable in the next few years. Personally I believe it will reach $8 by 2016.

Crimpy your figures are way to low the company is expecting to ramp up to 510 million rtf syringes in mid 2014 giving a profit of about 121 million dollars This should see a sp above $10.00 and does not include profit from the 1ml now in production or the unifil select announced yesterday

Yeah I like to be conservative I am really hoping it gets to $3 within 12mths. I am very excited about this company

pacestick said:

Crimpy your figures are way to low the company is expecting to ramp up to 510 million rtf syringes in mid 2014 giving a profit of about 121 million dollars This should see a sp above $10.00 and does not include profit from the 1ml now in production or the unifil select announced yesterday

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One has to take analyst price targets for what they are i.e price targets and not price guarantees. The GFC becoming worse could put paid to these 12month targets.

Having said this though, the numbers for this company certainly appear extremely compelling for those with a medium to long term view. The NASDAQ listing within the next couple of months may well bring a rerating.

UBIQUITOUS said:

One has to take analyst price targets for what they are i.e price targets and not price guarantees. The GFC becoming worse could put paid to these 12month targets.

Having said this though, the numbers for this company certainly appear extremely compelling for those with a medium to long term view. The NASDAQ listing within the next couple of months may well bring a rerating.

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Yes I realise the analyst price target is not a guarantee, and I don't believe they will hit $3 in 12 mths. I believe $2-2.50 is more achievable. I believe $5 in 5yrs so at current prices it is way undervalued. What do you guys think the chances of it going back to 0.50c are? or the chances of it never reaching $3 are?

Hi Crimpy, I've also been accumulating these shares lately.

Personally I think the downside is limited as there is reasonable broker and tipsheet coverage with good price targets, which are multiples of $1.

I would guess if there was a major meltdown with GFC part 2 it could go as low as 50c but more likely 60-70c.

The upside is large as you state, if they sell the quantities they are targetting, and with potentially further upside from Unifill Select and other devices. So could easily reach anywhere between $3-10 as it should also get a good p/e ratio for a major fast growing company in a dominant market position.

If they struggle with sales and are say 50% below forecasts or delayed, the price could have difficulty getting to the $2 or $3 mark, but imo should stay above $1, unless one or both of these become major issues.

I think this is a great buffet style company, with a great range of products with a competitive advantage of being superior technically (smaller / cheaper for distributors etc)

Hi Resource boom. Yes agree that this is a buffet style company. Did you know buffet is a huge fan/investor of Sanofi? As far as selling the qauntities.... based on the fact that they have the best technology and 100% support from at least 40% of the pharmaceutical volume....they will have no trouble selling their product... just producing enough of it!
As far as GFC 2 goes, well quite frankly I am sick of the bears/doom sayers etc. They have had their day. Time to go back into hybernation.

Cheers for the info. For some reason I can never spell his name correctly. Should fix my typo, "Buffett" lol

I might look into the whole SA thing further. I hope theres no GFC2 too.

I am a bit worried about all the negative sentiment lately about the markets. They are talking about how bad things are economically and that we are in a bear market rally and we are headed back down to march lows and possibly lower. I don't know how this will effect unilife, but it sure is worrying.

Airtime: Thurs. Nov. 26 2009 | 6:10 AM ET
Unilife Medical Solutions is planning to list on the Nasdaq. CNBC's Karen Tso speaks to CEO of Unilife Medical Solutions, Alan Shortall about this move.

Unilife Medical Solutions Plans to List on Nasdaq

resourceboom said:

Personally I think the downside is limited as there is reasonable broker and tipsheet coverage with good price targets, which are multiples of $1.

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Its the brokers who are causing the problems with their automated trading. This can only be swept away with fresh buying on fresh news. Perhaps the 20% market capture and the $3.50+ broker targets need to be revised upwards based on Unifill Select.

Alan Shortall bought at $1.13 and is highly unlikely to consider a takeover yet. However, rumour can be good for the share price, which is why he didn't dismiss it in the CNBC interview (see above post).

At the AGM on Monday, I hope he is interrogated on many points, and not just left to feed shareholders whatever he wants.

Dual listing gives Unilife a shot in the arm
Michael Bennet From: The Australian November 30, 2009 12:00AM

http://www.theaustralian.com.au/dua...-shot-in-the-arm/story-e6frg8zx-1225805140169

MEDICAL syringe maker Unilife could announce more contracts with pharmaceutical majors soon as it prepares its formal move to the US and a dual listing on the Nasdaq stock exchange early next year.
Unilife, which is developing a new syringe for the $US1.5 billion ($1.65bn) ready-to-fill syringe market, has a supply deal with the biggest global purchaser of pre-filled syringes, Sanofi-Aventis, but CEO Alan Shortall said more would follow.

"I would be pretty confident we'd have one in the first six months of next year, but it could be at any time; we are in very good relationships, very good discussions with the top 10, top 15 companies, he said on a visit from the company's new home base of Pennsylvania.

The French giant in July paid $16 million for the exclusive rights on top of $30m it pledged to the new syringe's development expected late next year, but Unilife can negotiate deals with other companies for certain drugs.

Shareholders are set to vote on the Nasdaq listing on January 8, but Mr Shortall said the move was "a no brainer" which would give shareholders flexibility and the company access to US capital. "My job is to build value for shareholders and I believe listing on Nasdaq is going to help to drive that," he said.

"The US is the biggest medical device market, the biggest capital market and it means we're stepping on to the stage with all the other majors."

Australian shareholders, which make up 95 per cent of the company's register, will be issued with CHESS depositary interests in Unilife USA, which will remain on the ASX but can also be traded on Nasdaq.

Mr Shortall said he expected Unilife to list on Nasdaq at between $US7 and $US10 -- higher than the previously slated Nasdaq minimum of $US4 -- thanks to the company's rising share price and strong Australian dollar.

UNILIFE MEDICAL SOLUTIONS LIMITED Video Webcast
Tue, 1 Dec 2009 11:30AM Australia/Sydney (Tue, 1 Dec 2009 11:30AM Australia/NSW)

Alan Shortall the ceo of UNI expects the company to have completed transferring to the nasdaq by mid febuary at that time he expects the sp on the nasdaq to be between seven and ten dollars which if divided by six to get the value of each cdi being held on the asx would be between $1.16 and $1.66. as the nasdaq is expected to then increase the value of the sp by three times being the amount the nasdaq values pharmas above that which the ASX does the price should move to between $3.48 and $5.00 . The three times increase is consistent with at least two analysts report and is probably conservative given that the australian market has missed the signficance of the recent announcements re the unifil select and the appointment of a manufacturing company to provide production lines