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8-K - FORM 8-K - Unilife Corp | c17286e8vk.htm |
EX-99.2 - EXHIBIT 99.2 - Unilife Corp | c17286exv99w2.htm |
Exhibit 99.1
Unilife Announces Financial Results for the Third Quarter of Fiscal 2011
York, PA (May 16, 2011) Unilife Corporation (Unilife or Company) (NASDAQ: UNIS; ASX: UNS) today
announced its financial results for the three and nine months ended March 31, 2011 (Third Quarter
of Fiscal 2011).
Recent Company Highlights:
| Began initial production of the Unifill® ready-to-fill (prefilled) syringe at York, PA facility |
| Initial product sales expected to commence in July 2011 |
| Initiated scheduled business realignment to enhance operational focus, improve
efficiencies and drive continuous growth |
| Strengthened frontline sales and marketing departments to expand and
consolidate commercial relationships with multiple pharmaceutical companies |
| Established organizational structure driven by dynamic project-focused
teams to enable innovation and speed for commercialization of multiple new devices |
| Accelerated discussions with multiple pharmaceutical companies for the Unifill syringe |
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| Emerging opportunities to develop other Unilife proprietary device technologies that can
be customized to address specific and currently unmet requirements for target biological
drugs in the R&D pipeline |
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| Signed term sheet with a large equipment financing company for up to $12.0 million in
financing for the initial production line for the Unifill syringe |
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| Strengthened Unilifes financial position, with the Company now expected to have
sufficient cash to sustain business operations until at least the end of fiscal 2012 |
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, The third quarter of fiscal 2011
marked a significant period for Unilife, as we initiated production of the Unifill syringe. With
this major milestone now completed, we are conducting final product validation procedures and
expect to commence initial sales of the Unifill syringe to pharmaceutical companies in July 2011.
In preparation for the ramp-up of commercial production, we also expanded our sales and marketing
teams to maximize commercial opportunities arising out of discussions that are now accelerating
with multiple pharmaceutical companies.
The revolutionary design of the Unifill syringe and its successful commercialization has given
Unilife the credibility and expertise to serve as a device innovation partner for pharmaceutical
companies. As a result, multiple pharmaceutical and biotech companies are now reviewing how other
devices in our portfolio, including extensions of the current Unifill technology platform, can be
customized for specific use with targeted biological drugs and vaccines in their development
pipelines.
We have recently implemented a scheduled realignment that helped to streamline our organization,
while simultaneously bolstering our sales, marketing and product development capabilities. These
steps have helped turbo-charge our business so that we can maximize sales of the Unifill syringe,
and drive innovation and speed into the commercialization of multiple new products across other
fast-growing device markets. As an additional side-benefit, this realignment is expected to reduce
our cash burn by approximately $12 million for the calendar year 2011.
Furthermore, I am pleased to announce that Unilife has signed a term sheet with an equipment
financing company to provide up to $12.0 million in financing for the initial manufacturing line
for the Unifill syringe, which is already installed at our York facility. We expect to close this
transaction by the end of May, allowing us to recoup $8.0 million in cash currently invested in
this equipment. In combination with the savings from our recent realignment plan, we believe we
will have sufficient cash to carry us through until the end of fiscal 2012, concluded Mr.
Shortall.
Unilife Corporation
250 Cross Farm Lane, York, PA 17406 T + 1 717 384 3400 F + 717 384 3401 E info@unilife.com W www.unilife.com
250 Cross Farm Lane, York, PA 17406 T + 1 717 384 3400 F + 717 384 3401 E info@unilife.com W www.unilife.com
Financial Results for Three and Nine Months Ended March 31, 2011
Revenues for the three months ended March 31, 2011 were $0.7 million compared to $2.4 million for
the same period in 2010. This decrease in revenue is largely attributable to a decrease of $1.2
million in milestone payments from Unilifes pharmaceutical partner associated with the
industrialization program for the Unifill syringe, as well as a decrease in revenue of $0.5 million
reflecting the Companys decision to discontinue its contract manufacturing operations and instead
focus on the commercialization, production and supply of its own propriety line of products.
The Companys net loss for the three months ended March 31, 2011 was $(12.5) million, or $(0.20)
per diluted share, compared to a net loss of $(12.1) million, or $(0.23) per diluted share, for the
same period in 2010. The increase in net loss is primarily attributable to the decrease in revenue
as noted above, and increased selling, general and administrative expenses due to higher payroll
and share-based compensation costs as the Company increased its workforce to meet key business
milestones. This increase was offset by a decrease in research and
development costs due to a decrease in non-cash share-based
compensation costs relating to stock awards granted in the prior
periods.
Adjusted net loss for the three months ended March 31, 2011 was $(9.3) million, or $(0.15) per
diluted share, compared to adjusted net loss of $(5.1) million, or $(0.10) per diluted share, for
the same period in 2010. Adjusted net loss in the current year period excludes approximately $3.2
million in expenses, including non-cash share-based compensation expense, depreciation and
amortization and interest expense compared to $7.0 million in non-cash expenses in the prior year
period due to lower non-cash share-based compensation costs relating to stock awards granted in the prior
period.
Revenues for the nine months ended March 31, 2011 were $6.0 million, compared to $8.8 million for
the same period in 2010. The decrease in revenue is primarily related to a decrease of $3.7 million
of milestone payments associated with the industrialization program for the Unifill syringe, as
these payments were accelerated in the prior period in recognition of the industrialization program
being ahead of the original schedule. This decrease was offset by an increase of $1.1 million in
contract manufacturing revenue, as revenues were accelerated during the first part of the period in
anticipation of the Companys decision to discontinue its contract manufacturing operations by the
end of the 2010 calendar year.
The Companys net loss for the nine months ended March 31, 2011 was $(30.1) million, or $(0.53) per
diluted share, as compared to a net loss of $(20.0) million, or $(0.45) per diluted share, for the
same period in 2010. The increase in net loss is attributable to the decrease in revenue as noted
above, and increased selling, general and administrative expenses due to higher payroll and
non-cash share-based compensation costs. This is offset by a decrease in research and development costs
due to a decrease in non-cash share-based compensation costs relating to stock awards granted in the
prior period, as well as a decrease in legal and consulting fees due to significant costs incurred
in the prior period in connection with our redomiciliation to the U.S.
Adjusted net loss for the nine months ended March 31, 2011 was $(20.8) million, or $(0.37) per
diluted share, compared to adjusted net loss of $(8.8) million, or $(0.20) per diluted share, for
the same period in 2010. Adjusted net loss in the current year period excludes approximately $9.3
million in expenses, including non-cash share-based compensation expense, depreciation and
amortization and interest expense compared to $11.3 million in non-cash expenses in the prior year
period due to lower legal and consulting fees due to significant costs incurred in the prior period
in connection with our redomiciliation to the U.S.
As of March 31, 2011, the Companys cash, cash equivalents and restricted cash were $30.2 million.
Conference Call Information
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Daylight Time on May 16,
2011, to review the Companys financial results, market trends 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, manufacturer and supplier
of advanced drug delivery systems with state-of-the-art facilities in Pennsylvania. Established in
2002, Unilife works with pharmaceutical and biotechnology companies seeking innovative devices for
use with their parenteral drugs and vaccines. Unilife has developed a broad, differentiated
proprietary portfolio of its own injectable drug delivery products, including the
Unifill® and Unitract® product lines of safety syringes with automatic,
operator controlled needle retraction. Unifill represents the worlds first prefilled syringe
technology integrating safety within the primary drug container. The products are ideally
positioned to help pharmaceutical companies maximize the lifecycle of their injectable drugs and
enhance patient care. Unifill syringes, together with other devices that are part of the Unilife
technology platform, can either be supplied to pharmaceutical customers ready for use, or
customized to address the specific requirements of targeted biological drugs. For more information
on Unilife, please visit www.unilife.com
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 managements 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 a 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, interest expense and certain non-recurring costs associated with our
redomiciliation and Nasdaq listing.
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
investors understanding, of the Companys 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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Investor Contacts (US):
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Investor Contacts (Australia) | |||
Todd Fromer / Garth Russell
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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 |
(Tables Below)
UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(unaudited)
Consolidated Balance Sheets
(unaudited)
March 31, 2011 | June 30, 2010 | |||||||
(in thousands, except share data) | ||||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 27,788 | $ | 20,750 | ||||
Restricted cash |
2,400 | | ||||||
Accounts receivable |
6 | 1,556 | ||||||
Inventories |
564 | 797 | ||||||
Prepaid expenses and other current assets |
430 | 637 | ||||||
Total current assets |
31,188 | 23,740 | ||||||
Property, plant and equipment, net |
53,562 | 29,972 | ||||||
Goodwill |
12,916 | 10,792 | ||||||
Intangible assets, net |
43 | 40 | ||||||
Other assets |
489 | 273 | ||||||
Total assets |
$ | 98,198 | $ | 64,817 | ||||
Liabilities and Stockholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 3,559 | $ | 6,044 | ||||
Accrued expenses |
3,060 | 2,911 | ||||||
Current portion of long-term debt |
2,297 | 1,648 | ||||||
Deferred revenue |
2,633 | 2,188 | ||||||
Total current liabilities |
11,549 | 12,791 | ||||||
Long-term debt, less current portion |
19,362 | 1,093 | ||||||
Deferred revenue |
5,924 | 6,563 | ||||||
Total liabilities |
36,835 | 20,447 | ||||||
Contingencies
Stockholders Equity: |
||||||||
Preferred stock, $0.01 par value, 50,000,000
shares authorized as of March 31, 2011; none
issued or outstanding as of March 31, 2011 and
June 30, 2010 |
| | ||||||
Common stock, $0.01 par value, 250,000,000
shares authorized as of March 31, 2011;
63,590,343 and 54,761,848 shares issued and
outstanding as of March 31, 2011 and June 30,
2010, respectively |
636 | 548 | ||||||
Additional paid-in-capital |
166,918 | 122,397 | ||||||
Accumulated deficit |
(109,787 | ) | (79,650 | ) | ||||
Accumulated other comprehensive income |
3,596 | 1,075 | ||||||
Total stockholders equity |
61,363 | 44,370 | ||||||
Total liabilities and stockholders equity |
$ | 98,198 | $ | 64,817 | ||||
UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
Consolidated Statements of Operations
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
(in thousands, except per share data) | ||||||||||||||||
Revenues: |
||||||||||||||||
Industrialization fees |
$ | | $ | 1,250 | $ | 1,350 | $ | 5,082 | ||||||||
Licensing fees |
642 | 576 | 1,849 | 2,006 | ||||||||||||
Product sales and other |
8 | 591 | 2,756 | 1,682 | ||||||||||||
Total revenues |
650 | 2,417 | 5,955 | 8,770 | ||||||||||||
Cost of product sales |
450 | 569 | 2,449 | 1,835 | ||||||||||||
Gross profit |
200 | 1,848 | 3,506 | 6,935 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
2,723 | 6,899 | 6,941 | 8,623 | ||||||||||||
Selling, general and administrative |
9,117 | 7,008 | 24,386 | 17,229 | ||||||||||||
Depreciation and amortization |
827 | 390 | 2,492 | 1,727 | ||||||||||||
Total operating expenses |
12,667 | 14,297 | 33,819 | 27,579 | ||||||||||||
Operating loss |
(12,467 | ) | (12,449 | ) | (30,313 | ) | (20,644 | ) | ||||||||
Interest expense |
177 | 30 | 241 | 91 | ||||||||||||
Interest income |
(128 | ) | (450 | ) | (332 | ) | (707 | ) | ||||||||
Other expense (income), net |
17 | 35 | (85 | ) | 15 | |||||||||||
Net loss |
$ | (12,533 | ) | $ | (12,064 | ) | $ | (30,137 | ) | $ | (20,043 | ) | ||||
Loss per share: |
||||||||||||||||
Basic and diluted loss per share |
$ | (0.20 | ) | $ | (0.23 | ) | $ | (0.53 | ) | $ | (0.45 | ) | ||||
UNILIFE CORPORATION AND SUBSIDIARIES
Reconciliation of Non-GAAP Measure
(in thousands, except per share data)
(unaudited)
Reconciliation of Non-GAAP Measure
(in thousands, except per share data)
(unaudited)
Three Months Ended | Nine Months Ended | |||||||||||||||
March 31, | March 31, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
$ | (12,533 | ) | $ | (12,064 | ) | $ | (30,137 | ) | $ | (20,043 | ) | ||||
Share-based compensation expense |
2,216 | 5,994 | 6,602 | 6,765 | ||||||||||||
Depreciation and amortization |
827 | 390 | 2,492 | 1,727 | ||||||||||||
Interest expense |
177 | 30 | 241 | 91 | ||||||||||||
Non-recurring costs associated with redomiciliation
& US listing* |
| 550 | | 2,685 | ||||||||||||
Adjusted net loss |
$ | (9,313 | ) | $ | (5,100 | ) | $ | (20,802 | ) | $ | (8,775 | ) | ||||
Adjusted net loss per share diluted |
$ | (0.15 | ) | $ | (0.10 | ) | $ | (0.37 | ) | $ | (0.20 | ) | ||||
*Includes legal, consulting and other professional fees incurred in connection with the Companys
redomiciliation to the United States and Nasdaq listing.
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