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8-K - FORM 8-K - Unilife Corp | c08530e8vk.htm |
EX-99.2 - EXHIBIT 99.2 - Unilife Corp | c08530exv99w2.htm |
Exhibit 99.1
Unilife Corporation Announces Financial Results
For Fiscal Year 2011 First Quarter
For Fiscal Year 2011 First Quarter
Lewisberry, PA (November 15, 2010) Unilife Corporation (Unilife or Company) (NASDAQ: UNIS; ASX:
UNS) today announced financial results for the three months ended September 30, 2010 (Fiscal Year
2011 First Quarter).
Recent Company Highlights:
| Construction of new global headquarters and production facility in York, PA remains
fully on schedule for completion in late-2010. Expected staff relocation during
mid-December 2010 |
||
| Transfer and installation of Unitract® and Unifill® automated
assembly lines into York facility scheduled to occur between late-December 2010 and early
2011 |
||
| Secured $18 million mortgage from Metro Bank in October 2010 to support the York
facility.
U.S. Department of Agriculture (USDA) agreed to guarantee $10 million of the loan |
||
| Commences Unitract 1mL syringe sales in the U.S. with appointment of IMCO, a national
co-operative of independent medical device distributors. Receives 510K FDA clearance for
Unitract 1mL Tuberculin syringe |
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated, During the first fiscal quarter of
2011, our business focus has continued to be directed towards building our operational capabilities
to meet projected demand from pharmaceutical and healthcare companies for our proprietary products.
We are pleased to advise that as a result of these efforts, this phase of significant investment in
our operational infrastructure is now nearing completion. In particular, we have made excellent
progress this quarter towards the completion of our new, state-of-the-art facility in York, PA and
the industrialization program for the Unifill syringe. We remain on schedule to move into the new
facility next month, with commercial production of the Unifill syringe scheduled to commence during
the third fiscal quarter of 2011.
Preparations for the commercial supply of the Unifill syringe to pharmaceutical customers are well
underway. Discussions with many interested pharmaceutical companies continue to accelerate in
parallel across several therapeutic markets, with Unilife also receiving prominent industry
attention during recent pharmaceutical events.
We are also pleased to have secured an $18 million mortgage with Metro Bank of Harrisburg for the
construction of our new facility in York, PA. We are especially grateful for the strong government
backing we have received for this project, with the Federal Government underwriting $10 million of
the mortgage and the Commonwealth of Pennsylvania also making significant contributions towards our
facilitys construction.
In addition, Unilife is delighted to announce the commencement of U.S. sales and shipments for its
Unitract range of 1mL syringes, with the signing of an agreement with Independent Medical Co-Op,
Inc. (IMCO), one of the nations largest co-operatives of independent medical device
distributors. IMCO is ideally positioned to act as a preferred, non-exclusive partner to support
our launch activities, given their specialist focus and market reach within those healthcare
sectors where the use of 1mL safety syringes is greatest. We look forward to working with IMCO and
their members to successfully introduce our Unitract 1mL syringes to U.S. healthcare facilities,
Mr. Shortall said.
Unilife Corporation
633 Lowther Road, Lewisberry, PA 17339 T + 1 717 938 9323 F + 717 938 9364 E info@unilife.com W www.unilife.com
Financial Results for Three Months Ended September 30, 2010
Revenues for the three months ended September 30, 2010 were $3.5 million compared to $3.1 million
for the same period in 2009.
The Companys net loss for the three months ended September 30, 2010 was $7.2 million, or $0.14 per
diluted share, compared to net loss of $2.1 million, or $0.06 per diluted share, for the same
period in 2009. The increase in the net loss was attributable to higher payroll and related
expenses due to increases in the workforce at the Lewisberry, PA facility, higher share-based
compensation expense, and increased research and development expenses to finalize the product
specifications of our Unifill syringe.
Adjusted net loss for the three months ended September 30, 2010, which excludes approximately $3.4
million in share-based compensation expense, depreciation and amortization and interest expense was
$3.9 million, or $0.07 per diluted share, compared to adjusted net loss of $0.7 million, or $0.02
per diluted share, for the same period in 2009.
As of September 30, 2010, the Companys cash, cash equivalents and restricted cash were $16.0
million, which included $7.0 million of restricted cash used to secure our bridge financing for our new
building.
Conference Call Information
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Standard Time on November 15,
2010, 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 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, operator-controlled needle retraction features which are fully
integrated within the barrel, and 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 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
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 |
(Tables Below)
UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
September 30, 2010 | June 30, 2010 | |||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 8,990 | $ | 20,750 | ||||
Restricted cash |
7,000 | | ||||||
Accounts receivable |
2,168 | 1,556 | ||||||
Inventories |
1,122 | 797 | ||||||
Prepaid expenses and other current assets |
680 | 637 | ||||||
Total current assets |
19,960 | 23,740 | ||||||
Property, plant and equipment, net |
36,045 | 29,972 | ||||||
Goodwill |
12,173 | 10,792 | ||||||
Intangible assets, net |
43 | 40 | ||||||
Other assets |
285 | 273 | ||||||
Total assets |
$ | 68,506 | $ | 64,817 | ||||
Liabilities and Stockholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 4,193 | $ | 6,044 | ||||
Accrued expenses |
3,228 | 2,911 | ||||||
Note payable |
6,900 | | ||||||
Current portion of long-term debt |
1,628 | 1,648 | ||||||
Deferred revenue |
2,477 | 2,188 | ||||||
Total current liabilities |
18,426 | 12,791 | ||||||
Long-term debt, less current portion |
1,053 | 1,093 | ||||||
Deferred revenue |
6,812 | 6,563 | ||||||
Total liabilities |
26,291 | 20,447 | ||||||
Stockholders Equity: |
||||||||
Preferred stock, $0.01 par value, 50,000,000
shares authorized as of September 30, 2010;
none
issued or outstanding as of September 30,
2010 and June 30, 2010 |
| | ||||||
Common stock, $0.01 par value, 250,000,000
shares authorized as of September 30, 2010;
55,480,455 and 54,761,848 shares issued and
outstanding as of September 30, 2010 and June
30, 2010, respectively |
555 | 548 | ||||||
Additional paid-in-capital |
126,064 | 122,397 | ||||||
Accumulated deficit |
(86,896 | ) | (79,650 | ) | ||||
Accumulated other comprehensive income |
2,492 | 1,075 | ||||||
Total stockholders equity |
42,215 | 44,370 | ||||||
Total liabilities and stockholders equity |
$ | 68,506 | $ | 64,817 | ||||
UNILIFE CORPORATION AND SUBSIDIARIES
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
Three Months Ended | ||||||||
September 30, | ||||||||
2010 | 2009 | |||||||
Revenues |
||||||||
Industrialization fees |
$ | 1,350 | $ | 1,745 | ||||
Licensing fees |
577 | 683 | ||||||
Product sales and other |
1,616 | 680 | ||||||
Total revenues |
3,543 | 3,108 | ||||||
Cost of product sales |
1,175 | 829 | ||||||
Gross profit |
2,368 | 2,279 | ||||||
Operating expenses: |
||||||||
Research and development |
1,005 | 399 | ||||||
Selling, general and administrative |
8,012 | 3,742 | ||||||
Depreciation and amortization |
787 | 291 | ||||||
Total operating expenses |
9,804 | 4,432 | ||||||
Operating loss |
(7,436 | ) | (2,153 | ) | ||||
Interest expense |
32 | 47 | ||||||
Interest income |
(122 | ) | (5 | ) | ||||
Other income |
(100 | ) | (131 | ) | ||||
Net loss |
$ | (7,246 | ) | $ | (2,064 | ) | ||
Loss per share: |
||||||||
Basic loss per share |
$ | (0.14 | ) | $ | (0.06 | ) | ||
Diluted loss per share |
$ | (0.14 | ) | $ | (0.06 | ) | ||
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 | ||||||||
September 30, | ||||||||
2010 | 2009 | |||||||
Net loss |
$ | (7,246 | ) | $ | (2,064 | ) | ||
Share-based compensation expense |
2,550 | 570 | ||||||
Depreciation and amortization |
787 | 291 | ||||||
Interest expense |
32 | 47 | ||||||
Non-recurring costs associated with
redomiciliation & US listing* |
| 457 | ||||||
Adjusted net loss |
$ | (3,877 | ) | $ | (699 | ) | ||
Adjusted net loss per share diluted |
$ | (0.07 | ) | $ | (0.02 | ) | ||
* | Includes legal, consulting and other professional fees incurred in connection with the Companys
redomiciliation to the United States and Nasdaq listing. |