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EX-99.2 - EXHIBIT 99.2 - Unilife Corp | c21975exv99w2.htm |
EX-99.3 - EXHIBIT 99.3 - Unilife Corp | c21975exv99w3.htm |
8-K - FORM 8-K - Unilife Corp | c21975e8vk.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
Unilife Corporation Announces Preliminary Financial Results
for the Fourth Quarter and Fiscal Year 2011
for the Fourth Quarter and Fiscal Year 2011
York, PA (August 30, 2011) Unilife Corporation (Unilife or the Company) (NASDAQ: UNIS; ASX:
UNS) today announced its preliminary financial results for the fourth quarter and fiscal year ended
June 30, 2011.
Corporate Highlights:
| Completed construction of new global headquarters and commercial production facility in
York, PA and successfully relocated entire staff (December 2010) |
| Appointed Dr. Ramin Mojdeh as Chief Operating Officer (February 2011), and continued to
expanded management team to support business growth related to the ramp up of Unifill sales
and marketing program, and commercialization of other pipeline devices (July 2011) |
| Initiated business realignment plan to improve cash flow and extend cash reserves by
over $12 million during calendar year 2011 (April 2011) |
| Further strengthened balance sheet with $10 million equipment financing agreement
through Varilease Finance, Inc. (August 2011) |
Device Portfolio Highlights:
| Secured U.S. FDA 510K Clearance for Unitract 1mL TB Syringe (September 2010). |
| Commenced sales of Unitract1mL syringes in U.S. (November 2010) |
| Commenced initial production of Unifill® prefilled syringes at new global
headquarters and manufacturing facility (March 2011) |
| Successfully completed the industrialization of the Unifill syringe (June 2011) |
| Secured initial agreement with a leading global pharmaceutical company for the
development of a pipeline product in conjunction with a pipeline biologic drug for targeted
organ delivery. The device was selected for clinical trials scheduled to commence from
calendar Q4 2011 to Q1 2012. (June 2011) |
| Commenced initial supply of the Unifill syringe to Sanofi (July 2011) |
| Commenced initial sales of Unifill syringe to a U.S.-based global pharmaceutical company
(July 2011) |
| Continued to diversify proprietary portfolio with development of Unifill EZMix
multi-chamber prefilled syringe (patent filed) and Unifill Auto-Injector (August 2011). |
Mr. Alan Shortall, Chief Executive Officer of Unilife, stated: The fourth quarter of fiscal 2011
was a momentous period that not only marked the end of an exciting and important year for Unilife,
but also helped set the stage for the sustained growth of our business as we move aggressively
toward the future.
The completion of many important milestones over the past year, coupled with the strong momentum
of many new and exciting business initiatives have kept us on track to rapidly emerge as a global
leader for advanced drug delivery systems. One of our most important achievements during the year
was the successful completion of the industrialization program for the Unifill® syringe in June and
the initial supply of the syringe in July.
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 <http://www.unilife.com>
As we have previously discussed, the innovative technology behind the Unifill syringe has not only
allowed us to expand into a full portfolio of prefilled safety syringes, but has also led to a rich
product pipeline of other self-injection, reconstitution and novel drug delivery systems. These additional
technology platforms have been developed in direct response to the unmet needs of pharmaceutical
companies, healthcare workers and patients. One of our devices for specialized organ delivery was
recently selected by a leading global pharmaceutical company for clinical trials scheduled to
commence later this year.
Finally, in order to support the immense amount of growth we are currently experiencing, we made
several strategic decisions this year that have strengthened our position moving forward. This
includes the expansion of our management team with some of the worlds top pharmaceutical and drug
delivery device professionals from leading industry companies. We also strengthened our cash
position with the realignment of our business to drive internal efficiencies, and signed an
equipment financing agreement earlier this month for $10 million in available funding.
Looking ahead, our Company has never been stronger or better positioned to capitalize on untapped
opportunities within an injectable drug delivery device market forecast to increase by 50% to a
total value of $15 billion in 2015. I look forward to updating you as we continue to focus on
serving the unmet needs of pharmaceutical companies through our uniquely designed innovation
strategy, improving the lives of healthcare workers and patients across the globe, while building a
stronger company that increases value for our stockholders, concluded Mr. Shortall.
Preliminary Financial Results for Three and Twelve Months Ended June 30, 2011
Revenues for the three months ended June 30, 2011 were $0.7 million compared to $2.7 million for
the same period in 2010. This decrease was 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 product sales of $0.8 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 June 30, 2011 was $(10.5) million, or $(0.17) per
diluted share, compared to a net loss of $(9.7) million, or $(0.18) per diluted share, for the same
period in 2010. The increase in the net loss was primarily attributable to the decrease in revenues
as noted above, higher depreciation and amortization and increased research and development costs
incurred to finalize the product specifications of our Unifill syringe. The increase in net loss
was partially offset by decreased selling, general and administrative expenses due to a reduction
in payroll costs resulting from the realignment announced at the end of the third quarter 2011,
lower non-cash share-based compensation expense and lower consulting costs
Adjusted net loss for the three months ended June 30, 2011 was $(6.3) million, or $(0.10) per
diluted share, compared to adjusted net loss of $(5.7) million, or $(0.11) per diluted share, for
the same period in 2010. Adjusted net loss in the current year period excludes $4.2 million in
expenses, including non-cash share-based compensation expense, depreciation and amortization and
interest expense compared to $4.0 million in the prior year period primarily due to higher
depreciation and amortization expense resulting from the new corporate headquarters and related
equipment placed in service during the year, partially offset by lower non-cash share-based
compensation expense relating to stock awards granted in the prior period.
Revenues for the year ended June 30, 2011 were $6.7 million compared to $11.4 million for the same
period in 2010. The decrease was primarily related to a decrease of $5.0 million of milestone
payments associated with the industrialization program for the Unifill syringe, as these payments
were recognized in 2010 due to the industrialization program being ahead of the original schedule.
The Companys net loss for year ended June 30, 2011 was $(40.7) million, or $(0.70) per diluted
share, compared to a net loss of $(29.7) million, or $(0.64) per diluted share, for the same period
in 2010. The increase in net loss was attributable to the decrease in revenues, higher depreciation
and amortization and increased selling, general and administrative expenses due to higher payroll
and non-cash share-based compensation expense, partially offset by 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. Additionally, research and development costs decreased due to non-cash
share-based compensation expense relating to stock awards granted in the prior period.
Adjusted net loss for the year ended June 30, 2011 was $(27.1) million, or $(0.47) per diluted
share, compared to adjusted net loss of $(14.5) million, or $(0.31) per diluted share, for the same
period in 2010. Adjusted net loss in 2011 excludes $13.5 million in expenses, including non-cash
share-based compensation expense, depreciation and amortization and interest expense compared to
$15.2 million in 2010 primarily 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 June 30, 2011, the Companys cash, cash equivalents and restricted cash were $20.3 million.
The financial data included in this press release is based on preliminary unaudited information and
may be subject to change. The Company expects to file its audited results for the year ended June
30, 2011 on Form 10-K with the Securities and Exchange Commission on September 13, 2011.
Conference Call Information
Management has scheduled a conference call for 4:30 p.m. U.S. Eastern Daylight Time on August 30,
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 share data)
(unaudited)
Consolidated Balance Sheets
(in thousands, except share data)
(unaudited)
June 30, | ||||||||
2011 | 2010 | |||||||
Assets |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents |
$ | 17,910 | $ | 20,750 | ||||
Restricted cash |
2,400 | | ||||||
Accounts receivable |
13 | 1,556 | ||||||
Inventories |
626 | 797 | ||||||
Prepaid expenses and other current assets |
381 | 637 | ||||||
Total current assets |
21,330 | 23,740 | ||||||
Property, plant and equipment, net |
54,020 | 29,972 | ||||||
Goodwill |
13,265 | 10,792 | ||||||
Intangible assets, net |
42 | 40 | ||||||
Other assets |
821 | 273 | ||||||
Total assets |
$ | 89,478 | $ | 64,817 | ||||
Liabilities and Stockholders Equity |
||||||||
Current Liabilities: |
||||||||
Accounts payable |
$ | 2,405 | $ | 6,044 | ||||
Accrued expenses |
2,696 | 2,911 | ||||||
Current portion of long-term debt |
2,274 | 1,648 | ||||||
Deferred revenue |
2,706 | 2,188 | ||||||
Total current liabilities |
10,081 | 12,791 | ||||||
Long-term debt, less current portion |
20,413 | 1,093 | ||||||
Deferred revenue |
5,412 | 6,563 | ||||||
Total liabilities |
35,906 | 20,447 | ||||||
Stockholders Equity: |
||||||||
Preferred stock, $0.01 par value, 50,000,000 shares
authorized as of June 30, 2011; none issued or
outstanding as of June 30, 2011 and 2010 |
| | ||||||
Common stock, $0.01 par value, 250,000,000 shares
authorized as of June 30, 2011; 63,924,403 and 54,761,848
shares issued, and 63,905,053 and 54,761,848 shares
outstanding as of June 30, 2011 and 2010, respectively |
639 | 548 | ||||||
Additional paid-in-capital |
169,590 | 122,397 | ||||||
Accumulated deficit |
(120,332 | ) | (79,650 | ) | ||||
Accumulated other comprehensive income |
3,775 | 1,075 | ||||||
Treasury stock, at cost, 19,350 shares as of June 30, 2011 |
(100 | ) | | |||||
Total stockholders equity |
53,572 | 44,370 | ||||||
Total liabilities and stockholders equity |
$ | 89,478 | $ | 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 | Year Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenues: |
||||||||||||||||
Industrialization fees |
$ | | $ | 1,236 | $ | 1,350 | $ | 6,318 | ||||||||
Licensing fees |
678 | 560 | 2,527 | 2,566 | ||||||||||||
Products sales and other |
17 | 856 | 2,773 | 2,538 | ||||||||||||
Total revenues |
695 | 2,652 | 6,650 | 11,422 | ||||||||||||
Cost of product sales |
148 | 636 | 2,597 | 2,471 | ||||||||||||
Gross profit |
547 | 2,016 | 4,053 | 8,951 | ||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
2,690 | 2,311 | 9,631 | 10,934 | ||||||||||||
Selling, general and administrative |
7,185 | 9,028 | 31,571 | 26,257 | ||||||||||||
Depreciation and amortization |
1,517 | 587 | 4,009 | 2,314 | ||||||||||||
Total operating expenses |
11,392 | 11,926 | 45,211 | 39,505 | ||||||||||||
Operating loss |
(10,845 | ) | (9,910 | ) | (41,158 | ) | (30,554 | ) | ||||||||
Interest expense |
270 | 34 | 511 | 125 | ||||||||||||
Interest income |
(67 | ) | (359 | ) | (399 | ) | (1,066 | ) | ||||||||
Other (income) expense, net |
(503 | ) | 120 | (588 | ) | 135 | ||||||||||
Net loss |
($10,545 | ) | ($9,705 | ) | ($40,682 | ) | ($29,748 | ) | ||||||||
Loss per share: |
||||||||||||||||
Basic and diluted loss per share |
($0.17 | ) | ($0.18 | ) | ($0.70 | ) | ($0.64 | ) | ||||||||
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 | Year Ended | |||||||||||||||
June 30, | June 30, | |||||||||||||||
2011 | 2010 | 2011 | 2010 | |||||||||||||
Net loss |
($10,545 | ) | ($9,705 | ) | ($40,682 | ) | ($29,748 | ) | ||||||||
Share-based compensation expense |
2,420 | 3,291 | 9,022 | 10,056 | ||||||||||||
Depreciation and amortization |
1,517 | 587 | 4,009 | 2,314 | ||||||||||||
Interest expense |
270 | 34 | 511 | 125 | ||||||||||||
Non-recurring costs associated with redomiciliation
& US listing* |
| 46 | | 2,731 | ||||||||||||
Adjusted net loss |
($6,338 | ) | ($5,747 | ) | ($27,140 | ) | ($14,522 | ) | ||||||||
Adjusted net loss per share diluted |
($0.10 | ) | ($0.11 | ) | ($0.47 | ) | ($0.31 | ) | ||||||||
*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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