UNS - Unilife Corporation

[skc]

Quarterly out.

Revenue: $132K
Net loss: $10.4M
YTD Loss: $41.3M

This is the period of "hyper growth".

The contract is about to be signed. To sign the contract there are lots of processes. I believe they are currently at the stage where the special ink to be used for the signing is being extracted from an unnamed exotic plant cutivated by a group of secretive monks living in the Swiss alps.

If you are that impatient, I won't tell you that the ink is not even the critical path. The paper which the signed contract will be printed on is made from a special tree that takes 50 years to mature. They planted the seed immediately after the essential terms are agreed upon. But hey these things take time, OK?!

 

[Sean K]

LOL. Kennas!

Yes, LOL.

The contract is about to be signed. To sign the contract there are lots of processes. I believe they are currently at the stage where the special ink to be used for the signing is being extracted from an unnamed exotic plant cutivated by a group of secretive monks living in the Swiss alps.

If you are that impatient, I won't tell you that the ink is not even the critical path. The paper which the signed contract will be printed on is made from a special tree that takes 50 years to mature. They planted the seed immediately after the essential terms are agreed upon. But hey these things take time, OK?!

Now 6 August.

7 weeks later no contract.

I hope I'm wrong for holders and I eat my words but this is a long trend of promising the world and failing to deliver.

That ATM facility will surely be tapped again.

But, it wasn't supposed to be!!!!

11 Oct 12

Most recently, market misperceptions over an at-the-market (ATM) agreement with Cantor Fitzgerald last week for the potential sale of up to $45M in common stock over time at the sole discretion of the Company have driven shares to near all-time lows since listing on NASDAQ in 2010. Shortly after the ATM agreement, $UNIS announced an expansion of the Company’s commercial development team including the appointment of four senior executives (details undisclosed at this time) from the drug delivery device industry.

$UNIS also announced it has no near-term plans to sell stock through the ATM facility (http://finance.yahoo.com/news/unilife-expands-commercial-development-team-120000054.html) and has not yet sold any stock in the deal, which was misperceived by some as having already occurred. In addition, the ATM facility provides the Company with leverage in partnership discussions as it provides access to capital on flexible terms that could be utilized for manufacturing scale-up to support commercialization and expansion activities.

http://proactivecapital.com/2012/10...o-rebound-sharply-from-market-misperceptions/

This was supposed to be for "manufacturing scale-up to support commercialization and expansion activities."

Expansion of what??

 

[Sean K]

10 May

Alan D. Shortall, Chief Executive Officer & Director

Thank you, Todd. Good afternoon and good morning to those in Australia. Before we discuss the quarter, I’m excited to tell you that we are getting ready to announce our first major long-term supply contract for the Unifill syringe. This is a significant multiyear commercial supply contract, with a major pharmaceutical customer that generates revenue immediately.

The negotiations for this agreement are complete. All terms have been agreed upon. The execution copy is being routed for signature by both parties. This agreement will establish Unilife as one of the leading supplier of pre-filled syringes in our industry. It also reaffirms all aspects of our business model.

June 17, 2013

Dear Unilife stockholders

I am pleased to advise that multiple deals with pharmaceutical customers relating to our Unifill ® platform and other game-changing technologies are now either complete or in the final stages of negotiation.

We have successfully completed negotiations with a global pharmaceutical company for a major long-term supply contract for the Unifill syringe as referred to during our last earnings call. I can advise that this contract is finalized with all terms having been agreed upon by both parties. The formal process of having the execution copy of the contract signed is now taking place, and we have been advised by the customer that it may require an additional few days or weeks to complete. While this process is taking slightly longer than both parties originally anticipated, it is understandable given the size of the Company and the number of steps involved.


With so many programs with so many customers now accelerating rapidly in parallel, a steady progression of transformational, revenue-generating announcements can be expected between now and the end of the calendar year. Together, I expect these upcoming agreements will herald our emergence as the new global leader for injectable drug delivery. We remain fully on track to achieve our business milestones for calendar year 2013 and beyond. Thank you for your continued support.

Yours sincerely
Alan Shortall CEO

July 31, 2013

Dear Shareholders,

Your Board, management team and employees have worked hard for many years to reach that critical point when all the pieces come together. For Unilife, that time is now. A large and growing number of pharmaceutical companies are seeking to partner with Unilife in recognition of how our game-changing products, world-class team and advanced operational capabilities can enhance and differentiate their injectable therapies. Several pharmaceutical companies have selected Unilife for major drug programs that we expect will be progressively announced and generate upfront payments during this calendar year.

I expect the announcement of these programs will transform Unilife. We are advised that a commercial supply agreement for the Unifill syringe remains in the formal process of being signed by a global pharmaceutical company. Agreements with several other pharmaceutical companies have now been through multiple iterations and are fast approaching ratification. Payments are already being received from some customers for device programs prior to the finalization of pending contracts.

LOL

It's now 17 August.

Must be due for another letter to shareholders stating the same old same old...

 

[Sean K]

Great Article in Forbes on Alan and his little charade.


How Is A $329M Syringe Company Still Unprofitable After 11 Years?

Classic

:horse:

 

[Sean K]

I hadn't seen this article before. Dates back to 2010, when Alan was paid $10m that FY.

Three years later, still no contracts actually making any profit.

This company is an amazing case study. In what I'm not sure.

Sharp end of the pay scale despite losses

 

[Draco5]

Unilife Signs Long-Term Supply Contract with Sanofi for the Use of Unifill ® Syringes with Lovenox ®

Unilife grants Sanofi long-term exclusivity subject to Sanofi purchasing 150 million Unifill syringes per year following a four-year ramp-up
Unilife to receive a minimum of $5 million and up to $15 million in milestone-based payments

YORK, Pa., Sept. 9, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife" or "Company" (NASDAQ: UNIS, ASX: UNS), a U.S. based designer, developer and manufacturer of injectable drug delivery systems, today announced the signing of a long-term supply contract with Sanofi.

Unilife has agreed to supply Sanofi with the Unifill Finesse™, a customized device from its Unifill ® platform of prefilled syringes with automatic, needle retraction, for use with the anti-thrombotic therapy Enoxaparin Sodium sold under the brand names Lovenox ® and Clexane ® ("Lovenox" . The contract period can extend up to 2024.

Unilife has granted Sanofi the exclusive use of the Unifill Finesse with anti-thrombotic drugs during the contract period. Following a four year ramp-up period after market entry, exclusivity will be maintained, subject to Sanofi purchasing a minimum of 150 million units of the Unifill Finesse or other Unifill syringes per year.

Unilife can supply its Unifill syringes, including the Unifill Finesse, to additional customers in all other therapeutic classes outside of anti-thrombotics.

In addition to future revenue from the sale of Unifill Finesse syringes, Unilife may receive up to $15 million from Sanofi in milestones based payments with $5 million of these payments expected in 2013.

This supply contract replaces and supersedes all other agreements previously signed between both parties regarding the Unifill syringe platform. For commercial purposes and due to confidentiality clauses in the Agreement, additional terms of the contract are to remain confidential.

Comments by Alan Shortall, CEO of Unilife

"Our Unifill syringes set a new standard for the delivery of all prefilled biologics, drugs and vaccines. Like other game-changing products in our broad device portfolio, the distinctive visual, safety and functional benefits of Unifill can be leveraged by pharmaceutical customers to enhance and differentiate their injectable therapies. We thank the Sanofi Industrial organization for their innovative vision and their support, and look forward to a long-term partnership."

"The signing of this supply contract reaffirms the business model we have worked so hard in pursuing. The long-term contract provides the customer with continuity of supply. The provision of exclusivity within a drug class also provides the customer with an opportunity to leverage our device's competitive advantages to drive user preference and differentiate their drug brands against competitors," Mr. Shortall concluded.

 

[skyQuake]

Well I'll be damned, there was a REAL contract!

Looks like it was sorta in response to the forbes article.
Might see some good short covering tonite.

 

[pacestick]

To the Editors:

The recent article on our company by Abram Brown is rife with misrepresentations of fact, false innuendo and serious inaccuracies regarding Unilife and our CEO Alan Shortall. The article is so clearly malicious and motivated by those with negative intentions that I am sure Unilife shareholders and employees will recognize it for the scurrilous journalism it is. We informed Forbes in advance of publication of the false and inaccurate information, but they chose to recklessly go forward anyway. As one example, the article suggests that Mr. Shortall received “$18 million in cash and stock in the last three years.” This is factually wrong. In this article, Forbes has carelessly combined the cash and equity compensation reported for Mr. Shortall over two consecutive three-year packages. For the record, Mr. Shortall’s base annual salary has been $420,000 since 2004 and is at the 50th percentile among the published industry peer group. Mr. Shortall’s equity compensation is in the form of restricted stock and stock options with significant performance and market-based milestones clearly aligned to build shareholder value, which were overwhelmingly voted in favor by shareholders. The market capitalization of the Company would have to increase to $1.5 billion, five times the current value, for all restricted stock and options to vest. Should these milestones not be achieved, Mr. Shortall will forfeit his right to the related options and restricted stock. Equity grants provided to Unilife’s COO, Dr. Mojdeh, are subject to similar performance or market-based milestones. We would like all readers to know that rather than give this baseless article any credibility, we will allow our performance over the coming months to speak for itself.

J. Christopher Naftzger
VP, General Counsel, Corporate Secretary & Chief Compliance Officer
Unilife Corporation

 

[skc]

Well I'll be damned, there was a REAL contract!

Looks like it was sorta in response to the forbes article.
Might see some good short covering tonite.

Lol. I am still picking up my jaw from the floor as well. May be they decided to sign the contract with normal pen and paper instead of following the original plan of exotic Swiss ink and paper

The contract is about to be signed. To sign the contract there are lots of processes. I believe they are currently at the stage where the special ink to be used for the signing is being extracted from an unnamed exotic plant cutivated by a group of secretive monks living in the Swiss alps.

If you are that impatient, I won't tell you that the ink is not even the critical path. The paper which the signed contract will be printed on is made from a special tree that takes 50 years to mature. They planted the seed immediately after the essential terms are agreed upon. But hey these things take time, OK?!

Interesting price action on UNIS. Spiked up 20% on open but closed only 4.5% higher on 6m volume (7x normal daily average).

 

[skyQuake]

In the arvo it was revealed UNS was getting sued by a former executive, and got a forbes write up !

In any case, looks like US sellers, Aussie buyers.

 

[skc]

In the arvo it was revealed UNS was getting sued by a former executive, and got a forbes write up !

In any case, looks like US sellers, Aussie buyers.

Yes.. not sure what the real story is but definitely good entertainment.

This is the best part...

He contends the company deliberately misled investors. When investors visited the facility, Smith says, Unilife ran fake production, turning the rural Pennsylvania factory into something like a Potemkin Village. According to the complaint, scrap went through the assembly line “to make it appear that Unilife was making product when it was not.”

http://www.forbes.com/sites/abrambr...vestor-fraud-sec-violations/?partner=yahootix

 

[Sean K]

If you read this announcement correctly, it's no sure deal. Again.

Unilife grants Sanofi long-term exclusivity subject to Sanofi purchasing 150 million Unifill syringes per year following a four-year ramp-up

So, Sanofi don't have to purchase the 150m syringes and if they don't there's no exclusivity agreement.

And the additional milestone payments will only be received if they reach the milestones. Milestones we do not know because of "confidentiality clauses."

And this announcement just a few days after spiking and they stated they knew nothing.


Interesting Forbes article but isn't that old news? Some pretty wild claims there. Surely if they're true it will come out through various other witnesses during proceedings. Could be the end of them if it's true.

 

[Sean K]

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Unilife Corporation – UNIS

NEW YORK, Sept. 9, 2013 /PRNewswire/ – Pomerantz Grossman Hufford Dahlstrom & Gross LLP is investigating claims on behalf of investors of Unilife Corporation. (“Unilife” or the “Company”) (NASDAQ: UNIS). Such investors are advised to contact Robert S. Willoughby at rswilloughby@pomlaw.com or 888-476-6529, ext. 237.

The investigation concerns whether Unilife and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934. On September 4, 2013, an article was published in FORBES magazine questioning the veracity of the company’s financial statements. On this news, shares of Unilife fell more than 14% from the previous day’s close, from $3.55 to $3.03. On September, 9, 2013, an ex-employee of the company, Talbot Smith, filed a whistleblower lawsuit against the Company alleging fraud and violations of the federal securities laws.

The Pomerantz Firm, with offices in New York, Chicago, San Diego and Florida, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, the Pomerantz Firm pioneered the field of securities class actions. Today, more than 70 years later, the Pomerantz Firm continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered numerous multimillion-dollar damages awards on behalf of class members. See www.pomerantzlaw.com.



Oh dear.

 

[Sean K]

Even the Eureka Report has misunderstood the announcement.

It's not a contract to purchase 150m syringes.

They haven't agreed to buy any by this statement:

Unilife grants Sanofi long-term exclusivity subject to Sanofi purchasing 150 million Unifill syringes per year following a four-year ramp-up

This is a very deceptive announcement.


Possible fraud dogs Unilife

The Unilife Corporation (UNS) rollercoaster ride took another unexpected plunge today even as management secured an important contract with pharmaceutical giant Sanofi.

Shareholders should have been rewarded by the highly anticipated news that could generate more than $100 million in annual revenue for Unilife.

But corporate governance issues are dogging the stock, which crashed 7.8% in lunch time trade to 59 cents.

Unilife’s woes began when a recent article by Forbes highlighted credibility issues with management. Investors are further spooked by news that the company could be facing a class action lawsuit against its directors for allegedly breaching US Securities Exchange Act.

Separately a former ex-employee, Talbot Smith, has filed a whistle-blower lawsuit against Unilife for possible fraud and violations of the US federal securities act.

The allegations have overshadowed Unilife’s contract, which will see Sanofi purchase 150 million of its retractable syringes that will be pre-filled with Sanofi’s anti-coagulation drug.

Unilife will receive milestone payments of between $5 million and $15 million, on top of a royalty for every syringe sold. Some analysts estimate that the royalty payment could be worth as much as $100 million a year.

Unilife, which is listed in Australia and the US, is part of the Uncapped 100.

 

[Sean K]

At tleast The Australian has got this deal more correct.

JOHN DURIE
Big pharma deal a fillip for biotech
BY:CRITERION From: The Australian September 11, 2013 12:00AM

Unilife (UNS) 58.5c: Four months after the Pennsylvania-based Unilife flagged a deal with big pharma to supply pre-filled syringes -- sparking a 128 per cent share spike -- the shaking hand has finally signed the paper.

But after climbing 14.5 per cent in New York trading on Monday night, Unilife's local CDIs plunged 5.5c (8 per cent) yesterday.

As is always the case with biotech deals, the devil is in the detail, not that we'll find out given big drug companies are paranoid about secrecy.

The deal, with French giant Sanofi, involves Sanofi using Unifill's Finesse syringes to deliver its anti-thrombosis drugs Lovenox and Clexane. The deal is exclusive to Sanofi for the thrombotic stuff, as long as Sanofi buys a minimum 150 million syringes.

Unilife expects "up to" $15 million from milestone payments, $5m in this year. The deal supersedes a 2008 deal with Sanofi, in which Sanofi paid a $16m licence fee for general use of Unifill's ready-to-fill syringes and bore an estimated $24m-$27m of "industrialisation costs".

The latest agreement is narrower in scope but frees up Unilife to strike royalty deals elsewhere.

In the meantime, US mag Forbes has gone on the attack again after a scathing piece last week, questioning why the $320m market-cap Unilife was still making a loss after 11 years.

Forbes has aired allegations of fraud and other violations in an unfair dismissal lawsuit filed by former Unilife executive Talbot Smith. "It's old news," says Unilife's local director Jeff Carter, who says 15-20 per cent of the stock has been shorted. We rated the overpromising, under-delivering Unilife an avoid at 60.5c. The stock is a hold pending an investor phone-in today.

 

[Sean K]

Here's Alan's answer when questioned about the Forbes article.

Um, I thought he was a marketing guru.


Our next question comes from Keith Markey from Griffin Securities.

Keith Albert Markey - Griffin Securities, Inc., Research Division

Just wondering if you could comment on the recent Forbes articles. We've certainly seen their effect on your stock price, and I'd like to hear it from you.

Alan D. Shortall - Chief Executive Officer, Executive Director, Member of Strategic Partnerships Committee and Chief Executive Officer of UMSL

Yes. Keith, thank you. Obviously, very disappointing. And I hate to dignify what I believe is a malicious piece of journalism from a reporter with little life experience due to his youth or business experience, with any comment at all. However, I perceive both articles as a vindictive attack on me personally as well as the company and all of its followers and supporters. I'm amazed by the arrogance of this young reporter, in fact. The articles as written are a slap in the face to you and some of Wall Street's top analysts and I'm including you in that, Keith, obviously, and some of the world's savviest portfolio managers, many of which are on this call. Both articles contain numerous misrepresentations of fact, misleading statements and serious inaccuracies regarding Unilife and myself as CEO. We sought to correct these errors and the statements with Forbes in advance of publication of the first article, but they chose to print the original, inaccurate and misleading content regardless. The second article, which appears to have been rushed to publication, just as the market began to digest the significance of our contract with Sanofi, it's -- that's of greater concern to Unilife and to me, notwithstanding the malicious personal attack on myself and Ramin's character or the fact that we were given virtually no opportunity for fact checking, we must question why Forbes was in such a rush to publish an article riddled with typos and grammatical errors within hours of us making the biggest announcement in our history. The article takes allegations from a former employee that was fired for cause and spins them as if they are facts. Given the content and timing of this second article, the Board of Directors and I feel that this was a calculated attack on Unilife, and we are investigating this matter and the motivations and factors behind it. But let me say this just to finish on that piece. If the Forbes article raised even a shred of a doubt about Unilife, its operations or mine or Ramin's business ethics, we are more than happy to host you and any other analysts or any of our investors to Pennsylvania at our facilities where we'll answer any questions. We are very transparent and an open book. As a matter of fact, we are planning to host an event for analysts, which we had to cancel earlier this year at our York facility in the coming months. And we're very proud of what we've come accomplished. And we have nothing to hide from our shareholders, customers or constituents. And these allegations from Smith that was -- had to stood down originally and asked to take 7 days leave while he stood down from his position to see if we could actually find a position for him within the organization, it's not a coincidence that 4 days later we received an anonymous complaint, an anonymous complaint, to which we actually thought came from somebody else. And then when we did terminate him 4 or 5 weeks later, we were then approached on the basis that we've fired him because he was a whistleblower. Now, the interesting thing is of the 4 or 5 weeks before that anonymous complaint with these allegations -- unfounded allegations come in, 4 or 5 weeks beforehand, as part of our corporate governance, which is very stringent, we got our executives to sign off before we do our earnings release, to sign off that as far as their judgment, they certify that there's no fraud or no issues in the company to which they believe that we should have informed the market. And he certified 4 to 5 weeks before that anonymous complaint saying that there was nothing to his [indiscernible]. So either it was a -- and my opinion, personally, he was actually fully misleading us when he signed that, that he believes it, or else on the alternative, when he actually put in the anonymous complaint. And we refused -- there was a -- we refused to what I believe was an extortion of money and we refused to pay it, to the extend with the threat of this public release of this information and that will give you how strongly I feel about it and how -- the fact is I have no concern because we've got containers load of documents to prove that what he says is actually malicious lies. So from that point of view, I could have settled for probably $120,000, $130,000, got him to sign a confidentiality agreement and got him to go away. I wouldn't do it. I won't have somebody extort money from us, I'd rather have it in the public arena and show just how robust our corporate governance is. And the FDA came in, in May with 4 days, with 2 auditors and they went through all our quality systems, to which most of the allegations relate to our quality and regulatory issues, and the FDA had no findings. In fact, in the final sign-off, they said to me that our quality system was exemplary for a medical device company. So that's it. You asked a simple question, Keith, I'm sorry.

 

[Sean K]

Wow, this guy Abram Brown is on a vendetta.

Unilife: Former Executive's New Lawsuit Alleges Investor Fraud, SEC Violations

Nice work.

 

[Sean K]

Latest quarterly financials out and they lost another $10m give or take. The 'immediate' revenues mentioned months ago have brought in a few hundred k by the look but it's not yet attributed to anything.

The ATM facility that was not going to be tapped except for expansion is being used to pay the bills and the ridiculously large wages to a few executives.

In addition, they are being sued by a second employee for securities fraud which they did not advise the market of until they got a please explain from the SEC after unusual volume and the sp tanking.

 

[pacestick]

Unilife Announces Supply Agreement with MedImmune for Wearable Injectable Drug Delivery Devices


YORK, Pa., Nov. 11, 2013 /PRNewswire/ -- Unilife Corporation (NASDAQ: UNIS, ASX: UNS), a U.S. based designer, developer and manufacturer of injectable drug delivery systems, today announced an agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to customize and supply devices from its platform of wearable injectors for use with molecules in MedImmune's pipeline.

Under this agreement, Unilife will supply MedImmune with customized devices from its platform of ReadyToGo™ wearable injectors. Several drug candidates from MedImmune's portfolio may be selected for use with Unilife's wearable injectors under the agreement.

Mr. Alan Shortall, Chief Executive of Unilife, said, "This is the dawn of a new era for injectable drug delivery where a very sophisticated new class of wearable, disposable devices will allow patients to deliver the most advanced therapies with maximum comfort and convenience. I am delighted that Unilife is setting the standard in serving biotech customers, such as MedImmune, and their patients within this category."

"We are pleased that MedImmune selected Unilife's technology after conducting a thorough evaluation process to identify simple and convenient wearable injectors that can be used to administer an injectable therapy wherever the patient is," Mr. Shortall concluded.

Unilife will generate revenue starting in the first quarter of fiscal 2014 on the basis of the customization and supply of its products to MedImmune. Additional terms of the contract have not been disclosed.

The wearable injection category is expected to generate device sales in excess of $3 billion within five to seven years.

Conference Call Information

Unilife is hosting its quarterly earnings conference call at 4:30 p.m. U.S. EST today, during which the Unilife management team will review its financial results for the quarter ended September 30, 2013, this contract, other commercial partnerships and its future outlook. To listen, please go to: http://ir.unilife.com/events.cfm.

About the ReadyToGo Wearable Injectors

The Unilife portfolio of ReadyToGo wearable injectors is a game-changing platform that addresses the unmet needs of biotech customers in delivering high-dose volume therapies wherever the patients are. The ReadyToGo wearable injectors are supplied to the patient prefilled with the drug and ready-for-injection with no extra steps or parts required. Only three simple steps are required to inject the dose: peel, stick, click, with an on-body safety interlock, a Flexwear™ comfort catheter and an electronic user interface among an array of features that maximize patient comfort and awareness during all stages of use. The devices are designed to minimize disruption to a patient's normal daily lifestyle during the period of dose delivery.

The ReadyToGo wearable injectors are designed for integration with standard filling processes, utilize standard materials in the primary drug container and require no terminal sterilization. A fully programmable delivery regimen allows the bolus, basal or variable rate of dose delivery to be customized to specific customer, therapy and patient requirements. The electronics in the device can be easily detached and disposed for markets that require special electronics disposal procedures. A video of Unilife's platform of wearable injectors can be viewed on the Unilife website at http://bit.ly/19MYWTA.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife's broad portfolio includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel devices. Each of these innovative, differentiated platforms can be customized by Unilife to address specific customer, drug and patient requirements. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

Forward-Looking Statements

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 Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

General: UNIS-G

Investor and PR Contacts (US):


Analyst Enquiries


Investor Contacts (Australia)

Todd Fromer / Garth Russell


Lynn Pieper


Jeff Carter

KCSA Strategic Communications


Westwicke Partners


Unilife Corporation

P: + 1 212-682-6300


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P: + 61 2 8346 6500



SOURCE Unilife Corporation

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Unilife Corporation
250 Cross Farm Road , York, PA 17406
Service provided by Shareholder.com

 

[pacestick]

YORK, Pa., Nov. 11, 2013 /PRNewswire/ -- Unilife Corporation ("Unilife" or "Company") (NASDAQ:UNIS; ASX: UNS), a developer and supplier of injectable drug delivery systems, today announced its financial results for the quarter ended September 30, 2013, (the first quarter of Fiscal Year 2014).

Recent Highlights

In September 2013, Unilife announced the signing of a long-term supply contract with Sanofi. Unilife has agreed to supply Sanofi with the Unifill Finesse™, a customized device from its Unifill ® platform of prefilled syringes with automatic, needle retraction, for use with the anti-thrombotic therapy Lovenox ®/Clexane ®. The contract period can extend up to 2024. In October 2013, Unilife received the first $5 million payment from Sanofi under the commercial supply agreement. Revenue from this payment has not yet been recognized, and was recorded as deferred revenue in the September 30, 2013 balance sheet.
Earlier today, Unilife announced another cornerstone agreement with MedImmune, the global biologics research and development arm of AstraZeneca, to customize and supply devices from its platform of wearable injectors. Under this agreement, Unilife will supply MedImmune with customized devices from its platform of ReadyToGo™ wearable injectors. Several drug candidates from MedImmune's portfolio may be selected for use with Unilife's wearable injectors under the agreement. Unilife begins generating revenue starting in Q1 FY14 on the basis of customization and supply of its products to MedImmune.
Unilife continues to accelerate the expansion of its customer base, and has multiple customers in its commercial pipeline. Information regarding each customer partnership will be announced when it can be disclosed.

Mr. Alan Shortall, CEO of Unilife, commented: "As I have said all along, fiscal year 2014 is the inflection point for Unilife when we begin to show rapidly increasing revenue. As such, we reported revenue of $3.2 million in the first quarter of Fiscal Year 2014, which is an increase of 360% over the same quarter in the prior year. Although the comparison is against a small base, it is significant in that it shows the inflection point in our revenue. From here, I expect the slope to be significant.

"As we continue to increase our investment in R&D and operations, which is increasingly offset by our revenue, we are also narrowing our operating loss. As such, we have reported a 10% decrease in operating loss for the first quarter compared with the prior year period. The loss per share has narrowed by 25% to $0.12, compared with the prior year period. I anticipate sequential quarterly growth in Fiscal Year 2014, as well as significant annual growth this fiscal year and beyond.

"We are focused on rapid and significant growth in the long-term. To accomplish this, we will continue to increase our investment in R&D and operations, much of which will be offset by our increasing revenue. I am pleased with the results we are getting from our investment in these areas. A look at the breadth and quality of our product portfolio on our website shows how far we have come over the last two or three years. Although we can be cash flow positive this year, if we wanted to do so, it is not in the best long term interest of our shareholders. This is because limiting our investment in R&D today can dampen the growth we anticipate in 2017 and beyond," Mr. Shortall concluded.

Financial Results for Three Months Ended September 30, 2013

Revenue for the three months ended September 30, 2013, was $3.2 million compared to $0.7 million for the same period in 2012.

The Company's net loss for the three months ended September 30, 2013, was $11.2 million, or $0.12 per share, compared to a net loss of $12.5 million, or $0.16 per share, for the same period in 2012. Adjusted net loss for the three months ended September 30, 2013, was $7.1 million, or $0.08 per share, compared to $9.1 million, or $0.12 per share, for the same period in 2012. Adjusted net loss excludes non-cash share-based compensation expense, depreciation and amortization and interest expense.

Unilife reported $9.4 million of total cash and cash equivalents, including $2.0 million in restricted cash as of September 30, 2013. This does not reflect the first $5 million payment from Sanofi under the commercial supply agreement, which was received in October 2013.

Conference Call Information

Management has scheduled a conference call for 4:30 p.m. U.S. EST on Monday, November 11, 2013, (Tuesday, November 12, 2013 at 6:30 a.m. AEDT), to review the Company's financial results, customer partnerships and future outlook. The conference call and accompanying slide presentation will be broadcast over the Internet as a "live" listen-only Webcast. An archive of the presentation and webcast will be available for 30 days after the call. To listen, please go to: http://ir.unilife.com/events.cfm.

About Unilife Corporation

Unilife Corporation (NASDAQ:UNIS / ASX: UNS) is a U.S. based developer and commercial supplier of injectable drug delivery systems. Unilife's broad portfolio of proprietary technologies includes prefilled syringes with automatic needle retraction, drug reconstitution delivery systems, auto-injectors, wearable injectors, ocular delivery systems and novel systems. Each of these innovative and highly differentiated platforms can be customized to address specific customer, drug and patient requirements. Unilife's global headquarters and state-of-the-art manufacturing facilities are located in York, PA. For more information, please visit www.unilife.com or download the Unilife IRapp on your iPhone, iPad or Android device.

Forward-Looking Statements

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 Annual Report on Form 10-K and those described from time to time in other reports which we file with the Securities and Exchange Commission.

Non-GAAP Financial Measures

U.S. securities laws require that when we publish any non-GAAP financial measure, we disclose the reason for using the non-GAAP measure and provide reconciliation to the most directly comparable GAAP measure. The presentation of adjusted net income (loss) and adjusted net income (loss) per share are non-GAAP measures. Adjusted net income (loss) represents net income (loss) calculated in accordance with U.S. GAAP as adjusted for the impact of share-based compensation expense, depreciation and amortization and interest expense.

Management believes the presentation of adjusted net income (loss) and adjusted net income (loss) per share provides useful information because these measures enhance its own evaluation, as well as investor's understanding, of the Company's core operating and financial results. Non-GAAP financial measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation of net income (loss) to adjusted net income (loss) is included in the attached table.

General: UNIS-G


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