Posted by Mike Sweeney on Wed, Sep 22, 2010 @ 10:52
Last week, Unilife Corp. (NASDAQ: UNIS) presented at Rodman & Renshaw's 2010 Annual Global Investment Conference in New York. UNIS was one of the featured corporate presentations in the Healthcare tract.
UNIS Rodman & Renshaw Presentation
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
About Rodman & Renshaw
Rodman & Renshaw Capital Group, Inc. (NASDAQ: RODM) is a holding company with a number of direct and indirect subsidiaries, including Rodman & Renshaw, LLC.
Rodman & Renshaw is a full-service investment bank dedicated to providing corporate finance, strategic advisory and related services to public and private companies across multiple sectors and regions. Rodman also provides research and sales and trading services to institutional investors. Rodman is the leader in the PIPE (private investment in public equity) and RD (registered direct offering) transaction markets. According to Sagient Research Systems, Rodman has been ranked the #1 Placement Agent in terms of the aggregate number of PIPE and RD financing transactions completed every year since 2005.
For more information visit Rodman & Renshaw on the Internet at www.rodm.com
Posted by Mike Sweeney on Wed, Sep 08, 2010 @ 08:35
Let's tell it like it is, we are a little myopic here in NYC so it was very interesting to see Unilife included in the S&P Australian 300 Index. From the press release:
"The S&P/ASX 300® Index is comprised principally of the 300 largest and most liquid stocks listed and traded on the Australian Stock Exchange. Inclusion in the S&P/ASX 300® Index is based on certain criteria regarding listing, size and liquidity and is rebalanced every six months.
"Standard & Poor's Index Services is the leading provider of equity indices in Australia, as such, being included in the S&P/ASX 300® Index is an important achievement for Unilife and will help increase our Company's visibility among investors in the Australian equity market," stated Alan Shortall, CEO of Unilife Corporation. "Membership in this widely followed index comes in addition to being included in approximately 25 indices in the U.S., including the Russell 2000, Russell Microcap and Russell Global indexes."
The S&P/ASX 300® provides up to an additional 100 small cap stocks to the S&P/ASX 200. This index is designed to address investment managers' needs to benchmark against a portfolio characterized by sufficient size and liquidity. S&P/ASX 300 is a component of the Australian indices that could be used as building blocks for portfolio construction.
Index performance data for the S&P/ASX 300® is available at http://www.standardandpoors.com/indices/sp-asx-300/en/us/?indexId=spausta300audff--p-au----"
Posted by Mike Sweeney on Tue, Sep 07, 2010 @ 09:55
Unilife's Chief Executive Officer Alan Shortall will be presenting at three upcoming investor conferences taking in New York and Boston during the month of September, 2010.
- Monday, September 13, Shortall will present at the Rodman and Renshaw Annual Global Investment Conference in New York at 10:25 a.m. EDT.
- On Wednesday, September 15, Shortall will present at the Stifel Nicolaus Healthcare Conference in Boston at 8:35 a.m. EDT.
- On Monday, September 20, Mr. Shortall will present at the UBS Global Life Sciences Conference in New York at 4:00 p.m. EDT.
Each of the conference presentations will be broadcast over the Internet as a "live" listen only Webcast. To listen, please go to: http://ir.unilife.com/events.cfm. An archive of each event will also be available for those unable to listen live.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
Posted by Mike Sweeney on Wed, Sep 01, 2010 @ 03:53 PM
Unilife (UNIS) had put out a number of press releases this week. The first dealt with the fourth quarter numbers:
"Revenues for the fourth quarter ended June 30, 2010 were $2.7 million compared to $7.7 million for the same period in 2009. Revenues for the fiscal year ended June 30, 2010 were $11.4 million compared to $20.0 million for the same period in 2009. The decrease was primarily attributable to a relative decline in revenues from the Company's industrialization agreement with sanofi-aventis in 2010, due to the accelerated receipt of milestone payments during 2009 because the industrialization program was running ahead of its original schedule. The Company has elected to prioritize its activities on the development and supply of its proprietary range of safety syringes. It has consequently reduced its business activities within the medical device contract manufacturing sector during this period.
The Company's net loss for the fourth quarter ended June 30, 2010 was $9.7 million or $0.18 per diluted share, compared to net income of $2.2 million, or $0.06 per diluted share for the same period in 2009. The Company's net loss for the fiscal year ended June 30, 2010 was $29.7 million or $0.64 per diluted share, compared to a net loss of $0.5 million, or $0.02 per diluted share for the same period in 2009. The increase in the net loss was attributable to both the decline in revenues as well as higher payroll and related expenses due to an increase in the workforce at the Lewisberry, PA facility.
As of June 30, 2010, the Company's cash and cash equivalents were $20.8 million."
UNIS also received FDA approval on its Unitract(TM) Tuberculin (TB) Syringe on top of its EC certification to apply the CE Mark to its Unitract(TM) 1mL syringes manufactured at its Lewisberry facility, allowing the sale and distribution of these products within the European Union and Australia.
Posted by Damian Schmidt on Mon, Aug 23, 2010 @ 12:35 PM
LEWISBERRY, Pa., Aug 23, 2010 /PRNewswire via COMTEX News Network/ -- Unilife Corporation ("Unilife" or "Company") (Nasdaq: UNIS; ASX: UNS) announced today that it intends to release its financial results for the fiscal 2010 fourth quarter and year ended June 30, 2010 after market trading ends on Monday, August 30, 2010.
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Time on August 30, 2010 (Tuesday, August 31 at 6.30 a.m. AEST), to review the Company's financial results, market trends, and future outlook. The conference call will be broadcast over the Internet as a "live" listen only Webcast.
To listen, please go to: http://ir.unilife.com/events.cfm.
Listeners are urged to login approximately 20 minutes before the conference call is scheduled to begin in order to register, as well as download and install any necessary audio software.
An archive of the webcast will be available for 30 days after the call.
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
This press release contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in other reports which we file with the Securities and Exchange Commission.
General: UNIS-G
Investor Contacts (US): Investor Contacts (Australia)
Todd Fromer/Garth Russell Stuart Fine Jeff Carter
KCSA Strategic
Communications Carpe DM Inc Unilife Corporation
P:+ 1 212 682 6300 P:+ 1 908 469 1788 P:+ 61 2 8346 6500
Posted by Mike Sweeney on Tue, Aug 17, 2010 @ 02:53 PM
Unilife Photo Gallery @ OSI
Posted by Mike Sweeney on Mon, Aug 02, 2010 @ 02:21 PM
Unilife Corporation has launched
Unitract.com to support the commercial release of its Unitract™ 1 mL clinical safety syringes. The web site contains in-depth product information on Unitract™’s technology, features and benefits as well as product variants and availability, a download section with training materials, and videos that provide a detailed look at functionality.
Unitract syringes provide an automatic choice for safe, simple injections. A uniquely passive safety mechanism allows operators to control the rate of needle retraction directly from the body to help protect those at risk of infection from needlestick injuries and aerosol. US-made and intuitive for use, Unitract™ 1mL syringes are helping to redefine injection safety standards for healthcare workers and patients which self-administer prescription medication.
Unitract Web Site
Posted by Mike Sweeney on Wed, Jul 28, 2010 @ 07:19
Unilife appointed
Marc S. Firestone, Executive Vice President and General Counsel for
Kraft Foods to Unilife's Board of Directors as a new independent director. Mr. Firestone will chair the Unilife Board's Nominating and Corporate Governance Committees and serve as a member of the Strategic Partnerships Committee.
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, "Adding Mr. Firestone to our Board reflects our dedication to growing Unilife and building upon our successes. We believe his far-reaching knowledge and vast legal and government relations experience with two Fortune 100 companies will provide us with exceptional guidance as we focus on our international business development initiatives. Additionally, his capabilities complement those of our existing team of experienced and talented board members. We expect to utilize his exceptional leadership skills and experience to their fullest as we move forward with our plans."
Mr. Firestone said, "The development of a unique and truly innovative range of safety syringes by Unilife represents a wonderful business opportunity to enhance the delivery of safe healthcare to people across the world. Having partnered with a number of nongovernment organizations, I understand how important it is for corporations not only to be profitable, but ideally to address societal needs at the same time. Unsafe injection practices represent a significant global challenge. I believe that Unilife and its pharmaceutical partners can make a genuine difference, and it's a privilege for me to be part of that effort. I'm excited by my appointment to the Unilife Board and look forward to making a valuable contribution to the continued success of the Company on the world stage."
Mr. Firestone, 50, leads the department that is responsible for legal, corporate affairs, government affairs, compliance, and corporate governance for Kraft Foods Inc., a Fortune 100 company and the largest food company in the United States with annual, worldwide sales of approximately $48 billion. In his current position, Mr. Firestone oversees 450 people around the world. He worked in Europe for seven years, and more recently has represented Kraft Foods before the U.S. Senate, UK Parliament, European Commission, and in meetings with public interest groups, community organizations and the media. He has also handled various matters for Kraft Foods before major U.S. regulatory agencies. Additionally, Mr. Firestone advised the Kraft Foods Board and executive management team on the legal, governance and communications aspects of numerous multibillion dollar transactions and acquisitions, including the recent acquisition of Cadbury plc for approximately $19 billion.
Prior to his position at Kraft Foods, Mr. Firestone held senior executive positions for Philip Morris Companies and its subsidiaries, including as Senior Vice President and General Counsel, Philip Morris International, and Senior Vice President of Regulatory Affairs, Phillip Morris Companies.
Mr. Firestone is a frequent public speaker on international competition law, diversity and in-house practice, and has received several awards, including the Distinguished General Counsel Award. He holds a juris doctorate from Tulane University School of Law in New Orleans, and a bachelor's degree from Washington & Lee University in Virginia. In addition to English, he is proficient in French and Italian.
Posted by Jeff Ramson on Mon, Jul 12, 2010 @ 02:03 PM
Alan Shortall-CEO at Unilife Corporation
Alan Shortall (CEO) is an experienced entrepreneur who has guided the growth and international development of Unilife since its inception.
Ever since Unilife was founded by CEO Alan Shortall in Australia in 2002, the Company has expanded rapidly to meet anticipated demand from pharmaceutical partners such as sanofi-aventis. Today, the U.S.-based and NASDAQ listed Company employs over 175 people. Since the Company relocated its core operational and commercial functions from the Australia to the US in 2009, Unilife’s engineering, quality and marketing capabilities have been significantly expanded to support core projects such as the Industrialization Program for its UnifillTM ready-to-fill Syringe.
Led by CEO Alan Shortall, Unilife recently bolstered its management team R. Richard Wieland II, a 30-year top executive for private and public life science companies, including CFO of Advanced Life Sciences Holdings, Inc., a NASDAQ-listed clinical-stage bio-pharmaceutical company.
The Company’s Board of Directors, which includes Alan Shortall and is led by Non-Executive Chairman, Jim Bosnjak, has also been significantly enhanced with the addition of Mary Kate Wold, former SVP of Wyeth (acquired by Pfizer for $68 Billion last year) as an independent director. The Board of Directors will continue to seek out additional members who will expand on the Board’s experience and knowledge base.The 'A' list team was assembled by Shortall shortly after Unilife became a U.S. FDA-registered and ISO 13485 certified medical device manufacturer of its proprietary and patented retractable syringes. Now Unilife is feverishly building out a state-of-the-art production facility near its new offices in central Pennsylvania. With a total size of three football fields, Shortall says that four shifts running 24/7 are on pace to finish the construct by year-end 2010. The giant push to production is being fueled by anticipated demand for Unilife's range of prefilled syringes from pharmaceutical industry leaders including sanofi-aventis (NYSE: SNY). In July 2009, sanofi-aventis (NYSE: SNY) entered into an industrialization agreement with Unilife, agreeing to approximately $40million in exclusivity fees and commercialization payments for the exclusive right to negotiate the purchase of the Unifill Ready-to-Fill Syringe (RTFS). The agreements give sanofi-aventis the exclusive right to negotiate the purchase of the Unifill syringe within the full therapeutic classes of antithrombotic agents and vaccines plus some other new smaller drug classes until June 30, 2014. Shortall is quick to remind fellow shareholders that Unilife retains the right to negotiate with other pharmaceutical companies seeking to utilize the Unifill syringe with drugs and vaccines marketed in therapeutic areas outside of those secured exclusively by sanofi-aventis.
The sanofi-aventis / Unilife relationship provides upside potential for Unilife shares and an added confidence in the management team created by Shortall. Even former critics like TheStreet.com's Jim Cramer, who panned Unilife shares back in April, have subsequently become fans. In a CNBC interview on Mad Money, Shortall addressed the concerns of Cramer, who said he “loves” sanofi-aventis but Unilife may be too dependent on this new alliance. Shortall began by demonstrating that the automatic, retractable, single use hypodermic needle does what it says it does and called the invention a 'disruptive' technology. Indeed, Unilife holds 26 issued patents in 14 countries, in addition to a number of patents pending, and Shortall underscored that markets are addressable beyond the $2.5 Billion pre-filled segment. Markets addressed by Unilife's products and services include its ready-to-fill safety syringes for pharmaceutical companies like sanofi-aventis; self-injectables of prescription medicine for individuals to control diabetes; harm reduction programs for IV drug users; safety, pre-filled, single-use syringes for healthcare facilities and humanitarian workers; and contract manufacturing of medical devices. Unilife is hardly dependent on any one company or market.
When Cramer asked Shortall about the price volatility in Unilife shares after it went public, Shortall said some of the shares did not transfer correctly from Australia (a delay of up to 3 days) to the NASDAQ, causing a short and then a spike in Unilife's share price. While Unilife shares have benefited from greater liquidity and market exposure in the U.S. (shares grew roughly 300% over the past 12-months), Wall Street gurus like Cramer add priceless value to a small-cap company such as Unilife. Cramer has since concluded that Unilife was a “great stock,” and gave his blessing on Unilife shares as a speculation. Post the interview, Unilife shares rose 20%.
Product sales from sanofi-aventis won't kick in on the income statement until late 2010 – early 2011 when production begins. However, Shortall said during Unilife's third fiscal quarter (ended March 31st) conference call that “significant proposals are being evaluated in U.S. and Europe.” The financials aren't reflecting this potential, as of yet. For the third fiscal quarter ended March 31, 2010, revenues were down to $2.4 million, compared to $4.1 million in March 31, 2009. Net loss of $12.1 million or $0.23 per diluted share, rose compared to a loss of $0.3 million or $0.01 per diluted share in the same period last year. Adjusted net loss for the quarter was $5.1 million or $0.10 per diluted share, compared to adjusted net income of $0.5 million or $0.01 per diluted share in the year-ago period. Unilife shares outstanding were 54,355,770 and 36,625,802 for the 2010 and 2009 periods, respectively.
Shortall explained that third quarter 2010 revenues were exclusively milestone payments, and not actual product sales. When Unilife signed the industrialization agreement with sanofi-aventis last year, and subsequently moved production 12-months ahead of schedule, sanofi-aventis accelerated its milestone payments, which created an artificial year-over-year loss on this year's quarter. Shortall pointed out that Unilife's net loss included $7 million in non-cash items, including share compensation, interest, depreciation, and one-time charges associated with relocation of Unilife to the U.S. Compensation in Unilife shares included $4.3 million paid to the inventors of Unilife's patents. Shortall said these payments were required by sanofi-aventis under the industrialization agreement, and protect Unilife's most important, revenue-generating assets (even though they don't show up on the balance sheet, added Shortall).
Another push to market is Unilife's FDA 510(k) market clearance for its Unitract™ 1mL safety syringe manufactured at its Lewisberry, PA facility, which can open up substantial opportunities to existing 'big pharma' as well as other healthcare distributors and government healthcare departments. Shortall says Unilife's unique selling proposition enables drug makers to expand the lifecycle of their blockbuster drugs, which currently generate about $80 Billion per year in revenues. With patents running out on today's top sellers, Shortall says Unilife's 501(k) clearance provides an opportunity to re-package and re-sell refillables as new products with an intra-muscular indication (until the 501 (k), the Unilife ready-to-fill product was for IV use only).
In light of legislation from Washington (the 2000 Needlestick Prevention Act), and emerging protocols in Europe and Asia that support the adoption of safe 'non-stick' needles, Unilife sees demand escalating worldwide. In developing economies like India, the need for one-use, safety syringes are great as healthcare risks run rampant without proper government guidelines. In addition to establishing a relationship with Mumbai-based Clinicare, Unilife has entered into a five-year agreement with Taiwan-based Stason Pharmaceuticals and its affiliate to be its exclusive Unitract sales partner covering Japan, China and Taiwan. The deal requires Stason to purchase a minimum of one million units of the Unitract™ 1mL syringe per year (an immediate annual order was placed at signing). Other countries within South-East Asia may be added to the list of designated territories given additional agreements on minimum orders for those countries, according to Shortall.
Shortall continues to ship out Unitract 1mL safety syringes to Haiti and will continue to support the safety of healthcare workers worldwide. Shortall said he is also accelerating discussions with major pharmaceutical companies for the Unifill™ syringe.
In the medical device industry, Unilife is rising up in the ranks. Medical Device & Diagnostic Industry Magazine (MD+DI) put Unilife as one of its “Top 50 Companies to Watch in 2010.” Shortall was previously named one of the “Top 100 Notable People in the Medical Device Industry.”
Shortall stays on point for the remainder of 2010, saying, “Unilife is focused on the delivery of four key goals: the on-time completion of the ready-to-fill syringe industrialization program; the successful production and commercial release of Unitract 1mL syringes; the continued expansion of Unilife operational capabilities; and the implementation of the Unlife corporate investment strategy that will build shareholder value.”
In other Unilife news:
On July 2nd, Unilife announced its resale Form S-1 registration statement became effective, permitting certain option holders to resell shares underlying their options. As previously advised, the Registration Statement simply removes restrictions which apply under US federal securities laws to the sale of shares underlying certain options previously issued by the Company.
The Registration Statement, while effective, allows the option holders to freely trade the shares issued or issuable upon exercise of their options (other than affiliates of Unilife to whom certain re-sale restrictions will still apply). The Company is not issuing any new share capital and will not receive any proceeds from the issue of the shares (other than the exercise price payable by option holders on exercise of their options).
On June 25th, Unilife was added to the Russell 3000®, Russell Microcap® and Russell Global® indexes. That was just another giant push in the right direction for a company that has seen record growth since its shares began trading on NASDAQ on February 16, 2010. Shares trade on the Australian Stock Exchange under UNS.
CEO of Unilife Corp., Alan Shortall, said in a press release, “Being included in the Russell indexes so soon after completing Unilife's listing on the NASDAQ Global Market is a significant validation of our redomiciliation from Australia to the U.S. Membership in these widely followed indexes will help increase Unilife's visibility among investors in the U.S. equity market." Nearly seven million Unilife shares traded the day the news broke, which is the equivalent of 41.7 million CHESS depositary interests (CDIs) with a value of approximately US$50 million. “We expect much of the increase in Unilife trading volume on (June 25th) represented the inflow of U.S. investors that track the Russell indexes.”
About Unilife Corporation
Unilife Corporation is a U.S.-based medical device company focused on the design, development, manufacture and supply of a proprietary range of retractable syringes. Primary target customers for Unilife products include pharmaceutical manufacturers, suppliers of medical equipment to healthcare facilities and patients who self-administer prescription medication. These patent-protected syringes incorporate automatic and fully-integrated safety features which are designed to protect those at risk of needlestick injuries and unsafe injection practices. Unilife is ISO 13485 certified and has FDA-registered medical device manufacturing facilities in Pennsylvania.
The information herein contains forward-looking statements. All statements that address operating performance, events or developments that we expect or anticipate will occur in the future are forward-looking statements. These forward-looking statements are based on management's beliefs and assumptions and on information currently available to our management. Our management believes that these forward-looking statements are reasonable as and when made. However, you should not place undue reliance on any such forward-looking statements because such statements speak only as of the date when made. We do not undertake any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. In addition, forward-looking statements are subject to certain risks and uncertainties that could cause actual results, events and developments to differ materially from our historical experience and our present expectations or projections. These risks and uncertainties include, but are not limited to, those described in "Item 1A. Risk Factors" and elsewhere in our registration statement on Form 10 and those described from time to time in our periodic reports which we file with the Securities and Exchange Commission.
Posted by Mike Sweeney on Thu, Jul 08, 2010 @ 09:44
Unilife Corporation, expanded its management team to include Christopher Naftzger as the Company's General Counsel, Corporate Secretary and Chief Compliance Officer. Mr. Naftzger will provide the management team and Board of Directors of Unilife with counsel on all international, legal and government matters as well as corporate finance and SEC regulation.
Prior to joining Unilife, Mr. Naftzger served on the senior management team as assistant general counsel and assistant secretary of Chesapeake Corporation, a global supplier of packaging to the pharmaceutical, healthcare and consumer industries. While at Chesapeake, Mr. Naftzger participated in all Board of Directors and Board Committee meetings as well as coordinated with the global sales team on negotiations for multi-year / multi-product supply contracts with a number of leading pharmaceutical and healthcare companies.
Mr. Naftzger has also served as the senior counsel at Koch Industries, Inc, the second largest privately held company in the U.S. with revenues of approximately $98 billion in 2008, and as a partner at Blank Rome LLP, a full service international law and government affairs firm. He holds a juris doctorate from Willamette University College of Law in Oregon, and a bachelor's degree from Hampden-Sydney College in Virginia.
Mr. Alan Shortall, Chief Executive Officer of Unilife, said, "We are pleased to add Chris to our executive team. We believe his extensive knowledge and experience as a lawyer and corporate secretary will be an asset as we continue to expand the Company, and build commercial relationships with a number of pharmaceutical customers. His appointment should also help to reduce outside legal costs in areas such as SEC compliance and contract negotiations."