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8-K - FORM 8-K - Unilife Corp | c24524e8vk.htm |
EX-99.2 - EXHIBIT 99.2 - Unilife Corp | c24524exv99w2.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Unilife Corporation Announces Financial Results
For Fiscal Year 2012 First Quarter
For Fiscal Year 2012 First Quarter
York, PA (November 9, 2011) Unilife Corporation (Unilife or Company) (NASDAQ: UNIS; ASX:
UNS) today announced financial results for the three months ended September 30, 2011 (Fiscal Year
2012 First Quarter).
Recent Highlights:
| Following the commencement of initial supplies of the Unifill syringe to customers (July
2011), Unilife has progressively increased production capacities at its York, PA facility. |
| Continued diversification of proprietary portfolio of advanced drug delivery systems |
| Developed EZMix, the first dual or multi-chamber prefilled syringe with
automatic (passive) safety features fully integrated within the glass barrel
(August 2011) |
| Developed Rita, a highly compact auto-injector for patient
self-injection with true end-of-dose indicators and automatic needle insertion and
retraction (August 2011) |
| Developed the AutoInfusor range of subcutaneous pump infusion systems
for the self-administration of large-volume drugs requiring dosages of 3mL or more
(September 2011) |
| Awarded two year contract with Premier Purchasing Partners, the nations largest
healthcare alliance, for the supply of the Unitract® range of 1mL safety
syringes (October 2011) |
| Executive purchases of the Companys stock totaling $1.0 million by Unilife CEO Alan
Shortall and $250,000 by COO Dr. Ramin Mojdeh. (September 2011) |
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated: Unilife made significant
advancements during the fiscal 2012 first quarter, as we continued to consolidate our position as a
leading developer of innovative, differentiated devices for the delivery of injectable drugs and
vaccines. Early in the quarter, we achieved one of the most important milestones in the Companys
history by commencing the supply of the Unifill syringe to pharmaceutical customers. We expect to
continue supplying these, and other customers, with larger volume orders moving forward.
In addition, we have announced several new technology platforms that address other unmet market
needs for injectable drug delivery. These innovative, new proprietary technologies include EZMix,
the worlds first dual or multi-chamber prefilled syringe with integrated safety; Rita, a highly
compact auto-injector with the worlds first true end-of-dose indicator, and our AutoInfusors, a
compact range of subcutaneous infusion pump systems for drugs requiring dosages larger than 3mL in
size.
Unilife Corporation
250 Cross Farm Lane, York, PA 17406 T + 1 717 384 3400F + 717 384 3401 E info@unilife.com W www.unilife.com
Im excited about the direction of the Company, and look forward to building on the positive
momentum we have been experiencing throughout the year, concluded Mr. Shortall.
Financial Results for Three Months Ended September 30, 2011
Revenues for the three months ended September 30, 2011, were $2.1 million compared to $3.5
million for the same period in 2010. This was primarily attributable to a decrease of $1.6 million
in product sales, reflecting the Companys decision to discontinue its contract manufacturing
operations in December 2010, and instead, focus on the commercialization, production and supply of
its own propriety line of products. During both the three months ended September 30, 2011 and 2010,
the Company recognized revenue related to a milestone payment under its industrialization
agreement. The milestone met during the three months ended September 30, 2011, was the last
remaining under the agreement, with Unilife having completed the Industrialization Program ahead of
the original schedule.
The Companys net loss for the three months ended September 30, 2011, was $9.7 million, or $0.16
per diluted share, compared to a net loss of $7.2 million, or $0.14 per diluted share, for the same
period in 2010. The increase in the net loss was primarily attributable to the decrease in
contract manufacturing revenues as noted above, as well as an increase in research and development
expenses related to the development of additional advanced drug delivery devices. These amounts
were partially offset by a decrease in selling, general and administrative expenses resulting from
a decline in non-cash, share-based compensation expense related to certain awards that are subject
to revaluation, as well as a decline in payroll and related expenses.
Adjusted net loss for the three months ended September 30, 2011, was $6.5 million, or $0.11 per
diluted share, compared to $3.9 million, or $0.07 per diluted share, for the same period in 2010.
Adjusted net loss in the current and prior periods excludes non-cash share-based compensation
expense, depreciation and amortization and interest expense.
Conference Call Information
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Standard Time on November 9,
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 novel drugs. For more information on
Unilife, please visit www.unilife.com
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 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 per share data)
(unaudited)
Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
September 30, | June 30, | |||||||
2011 | 2011 | |||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 17,383 | $ | 17,910 | ||||
Restricted cash |
2,400 | 2,400 | ||||||
Accounts receivable |
20 | 13 | ||||||
Inventories |
708 | 626 | ||||||
Prepaid expenses and other current assets |
374 | 381 | ||||||
Total current assets |
20,885 | 21,330 | ||||||
Property, plant and equipment, net |
53,881 | 54,020 | ||||||
Goodwill |
12,285 | 13,265 | ||||||
Intangible assets, net |
37 | 42 | ||||||
Other assets |
1,025 | 821 | ||||||
Total assets |
$ | 88,113 | $ | 89,478 | ||||
Liabilities and Stockholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 2,286 | $ | 2,405 | ||||
Accrued expenses |
2,021 | 2,696 | ||||||
Current portion of long-term debt |
5,879 | 2,274 | ||||||
Deferred revenue |
2,501 | 2,706 | ||||||
Total current liabilities |
12,687 | 10,081 | ||||||
Long-term debt, less current portion |
25,431 | 20,413 | ||||||
Deferred revenue |
4,376 | 5,412 | ||||||
Total liabilities |
42,494 | 35,906 | ||||||
Stockholders Equity: |
||||||||
Preferred stock, $0.01 par value, 50,000,000 shares authorized as of September 30,
2011; none issued or outstanding as of September 30, 2011 and June 30, 2011 |
| | ||||||
Common stock, $0.01 par value, 250,000,000 shares authorized as of September 30,
2011; 64,300,313 and 63,924,403 shares issued, and 64,274,703 and 63,905,053
shares outstanding as of September 30, 2011 and June 30, 2011, respectively |
643 | 639 | ||||||
Additional paid-in-capital |
171,952 | 169,590 | ||||||
Accumulated deficit |
(130,037 | ) | (120,332 | ) | ||||
Accumulated other comprehensive income |
3,187 | 3,775 | ||||||
Treasury
stock, at cost, 25,610 and 19,350 shares as of September 30, 2011 and June 30, 2011, respectively |
(126 | ) | (100 | ) | ||||
Total stockholders equity |
45,619 | 53,572 | ||||||
Total liabilities and stockholders equity |
$ | 88,113 | $ | 89,478 | ||||
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, | ||||||||
2011 | 2010 | |||||||
Revenues: |
||||||||
Industrialization fees |
$ | 1,440 | $ | 1,350 | ||||
Licensing fees |
672 | 577 | ||||||
Product sales and other |
18 | 1,616 | ||||||
Total revenues |
2,130 | 3,543 | ||||||
Cost of product sales |
74 | 1,175 | ||||||
Gross profit |
2,056 | 2,368 | ||||||
Operating expenses: |
||||||||
Research and development |
4,298 | 1,776 | ||||||
Selling, general and administrative |
6,183 | 7,241 | ||||||
Depreciation and amortization |
993 | 787 | ||||||
Total operating expenses |
11,474 | 9,804 | ||||||
Operating loss |
(9,418 | ) | (7,436 | ) | ||||
Interest expense |
283 | 32 | ||||||
Interest income |
(30 | ) | (122 | ) | ||||
Other expense (income), net |
34 | (100 | ) | |||||
Net loss |
$ | (9,705 | ) | $ | (7,246 | ) | ||
Loss per share: |
||||||||
Basic and diluted loss per share |
$ | (0.16 | ) | $ | (0.14 | ) | ||
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, | ||||||||
2011 | 2010 | |||||||
Net loss |
$ | (9,705 | ) | $ | (7,246 | ) | ||
Share-based compensation expense |
1,900 | 2,550 | ||||||
Depreciation and amortization |
993 | 787 | ||||||
Interest expense |
283 | 32 | ||||||
Adjusted net loss |
$ | (6,529 | ) | $ | (3,877 | ) | ||
Adjusted net loss per share diluted |
$ | (0.11 | ) | $ | (0.07 | ) | ||
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