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Griffin Securities reiterates Unilife Corp ($UNIS) target with $10.50 target
1. UPDATE REPORT
Medical Device Industry May 23, 2011
KEITH A. MARKEY, PH.D., M.B.A.
212-514-7914
KMARKEY@GRIFFINSECURITIES.COM
UNILIFE CORPORATION (NASDAQGM: UNIS)
Unilife ready to usher in a new era in drug delivery:
o Operations adjusted as full commercialization approaches
o Shipments of Unifill® syringes to start in July
o Long-term strategy centers on high-quality, specialty drug delivery devices
o Financial resources in place through fiscal 2012
We reiterate our BUY recommendation and our target price of $10.50 per share.
Share Price (5/20/11) $5.18
52-Week Price Low / High $3.85 - $7.08
Mkt. Capitalization (issued) $330 million
Shares Outstanding (issued) 63.85 million
12-month Target Price $10.50
Website www.unilife.com
FY 2011 Loss per share ($0.68)
FY 2012 Loss per share ($0.49) Source: BigCharts.com
Unilife Corporation (NasdaqGM: UNIS) is a the drug company’s most important revenue
medical device company with novel technologies sources, as well as four small subgroups in
for safety syringes with retractable needles. Its other areas. Validation shipments of one million
devices offer features preferred by the U.S. units in all are set to commence in early fiscal
Occupational Safety & Health Administration, 2012 (begins July 1st), enabling Sanofi to initiate
automatic activation of needle retraction and drug stability testing. Supply contracts should
user-controlled rate of retraction. Unilife’s first follow so that sufficient inventory is available for
syringe will have a fixed needle, though another 2013 commercial launches, just when
with interchangeable needles is not far behind. regulations requiring the use of safety syringes
will take effect throughout the European Union.
The Company’s most important product line is
its Unifill® brand of syringes, which have glass Unilife has begun talks with other drug
barrels and are designed to be prefilled with companies worldwide. Some may want
injectable drugs by pharmaceutical manufac- exclusive rights to Unifill syringes for their own
turers. Sanofi, the largest user of prefilled key therapeutic areas to gain a product
syringes in the world, provided $40 million to differentiator and competitive advantage. This
help set up the manufacturing system in strategy seems appropriate for both research-
exchange for the right to negotiate for exclusive based and large generic drug companies. But
access to the Unifill® fixed-needle syringe in exclusivity will come at a premium price, and
specific therapeutic areas. That negotiation was that will suit Unilife, since its strategy is to
completed with Unilife granting Sanofi exclusivity become the pharmaceutical industry’s preferred
for antithrombotic agents and vaccines, two of supplier of high-quality drug delivery devices.
Griffin Securities, Inc., 17 State Street, New York, NY, 10004 www.GriffinSecurities.com 1
Please Review Disclosures on Page 9 of this Research Report
2. Unilife Corporation May 23, 2011
UNILIFE ADJUSTS OPERATIONS TO FOCUS ON COMMERCIALIZATION
Management has been actively engaging drug manufacturers in discussions, which have led to several
requests for validation shipments. Additional personnel have been hired to enable upper management to
focus its attention more on operational issues. And in that regard, Unilife hired Ramin Mojdeh, an
experienced executive from Becton, Dickinson to serve as its Chief Operating Officer.
At the end of the March quarter of fiscal 2011 (ends June 30th), management started implementing
important initiatives to put the Company into a commercial mode of operation. This necessitated hard
choices that eliminated some positions, including the department that set up the Unifill manufacturing
system. The corporate reorientation also involved adding marketing expertise to expedite acceptance of
the Unifill syringe by the pharmaceutical industry.
The Company began forming product-oriented design groups to serve as the foundation of its R&D
program. These groups are comprised of personnel from multiple departments to ensure that all aspects
of new projects are addressed from the very earliest stages of design through commercialization. Each
team will have a dedicated orientation, either by project type or client. Unilife has already begun working
on specific projects for pharmaceutical companies that want to utilize its unique designs as a differentiator
for their drugs. The Company intends to work under contract on the development of new products,
thereby offsetting its R&D costs and limiting its risks.
In setting up the R&D design groups, Unilife is taking advantage of a trend toward outsourcing by the
pharmaceutical industry. But more importantly, the Company is positioning itself to become a preferred
provider of premium drug delivery devices. Underpinning this long-term strategy is its extensive patent
estate that forms a strong barrier against direct competition. We like this plan because it should maximize
the value of its patents, avoids the price-sensitive market of commodity devices, and limits investments in
capital equipment, notably the machinery that would be required to compete in the high-volume, generic
portion of the needle/syringe market.
VALIDATION SHIPMENTS OF UNIFILL SYRINGES TO START IN JULY
Unilife remains on target to deliver its first shipment of Unifill syringes to Sanofi in early July. This is
important for several reasons. First, it marks the fulfillment of the industrialization agreement between the
two companies through which Sanofi supported the development of the production process for this
syringe. Second, it demonstrates once more that Unilife is a reliable partner for pharmaceutical
companies – the Company has not missed a single milestone as it first set up operations in a leased
facility in Pennsylvania, registered its stock on NasdaqGM, financed an expansion of its infrastructure,
and subsequently moved into a new office/manufacturing plant of its own design. But just as important,
the validation shipments will open a new era for Unilife and the drug industry. The initial syringes will be
used for drug stability testing, a prerequisite to gaining regulatory approval of each drug-device
combination. The syringes must be able to hold the drug for two years without a loss of the drug’s
potency. This will not be a problem with the Unifill syringes, because the Company had the forethought to
ensure all components that come into contact with a drug are already used by the industry and have met
the stability requirements of regulators worldwide.
Once the validation shipments have begun, we believe corporate clients will engage in serious
negotiations for commercial supply contracts, since it will take time for both parties to build inventory in
preparation for launch. Sanofi should be among the first to arrive at the bargaining table, though they may
not necessarily be the first to sign a contract. That’s because they already have exclusive rights to their
two most important therapeutic areas, at least through mid-2014 as long as they commercialize products
in those areas by that time. Accordingly, other companies that are seeking access to Unilife’s technology
in their own areas of interest may have a greater motivation to sign exclusive supply agreements ahead
of their competitors. We believe Unilife will announce the deals in a timely manner, but it is possible that
their new clients will demand anonymity for competitive reasons. Similarly, we may not learn which drugs
will be supplied in Unifill syringes upon the completion of the contracts. The Company has already
indicated that discussions with potential clients have included both drugs that are already on the market
GRIFFIN SECURITIES EQUITIES RESEARCH 2
3. Unilife Corporation May 23, 2011
and others that are under development. (Note that there is a large number of biological agents in R&D
pipelines that must be injected.) Thus, near-term demand will depend heavily on which type of product is
involved in a supply contract and what geographic market(s) the drug-device combination will enter. Since
the European Union’s requirement for safety syringes goes into effect in 2013, we would not be surprised
if many of the earliest deals, entailing drugs available in prefilled syringes, will involve Unifill syringes
destined for Europe. As shown in the following chart, there are 83 drugs (left scale: number of drugs)
approved or in R&D pipelines at 19 companies in the pharmaceutical industry that are now available or
are suitable for subcutaneous administration via a prefilled Unifill syringe.
Chart 1. Potential Target Drugs for the Unifill Syringe
14 Other
Vaccines
12 Respiratory
MS
10 Musculo Skeletal
Immunosuppresants
Immunostimulants
8
Hormone Therapy
Diabetes
6
Bone Calcium
Regulation
Analgesics
4
Anti rheumatics
Alzheimer's disease
2
Anti infectives
Anti thrombotics
0
Anti neoplastics
Sanofi aventis
P10
P11
P12
P13
P2
P3
P4
P5
P6
P7
P8
P9
Other
FINANCIAL RESOURCES IN PLACE THROUGH FISCAL 2012
The operational changes that recently took place resulted in one-time severance costs and extra stock-
based compensation in the third fiscal quarter. With these expenses and the cost of moving into the new
headquarters/manufacturing complex in the prior period now behind the Company, we are looking for
operating costs to decline in the fourth fiscal quarter and then increase gradually as infrastructure
expands to satisfy clients’ demands for outsourced R&D support and for syringe production. (See pages 6
and 7 for income statements by quarter and fiscal year, respectively.) These estimates are consistent with
the announced $12 million cost-reduction achieved with the recent operational reorganization.
The cost savings should reduce Unilife’s cash burn through the end of fiscal 2012. Indeed, the Company
has stated that a recent $12 million credit line for equipment financing that will yield $8 million initially (for
equipment in place), plus the cash that it already has on its balance sheet (see page 4) will fund
operations through the next fiscal year. Nonetheless, Unilife has filed a registration statement that will
enable it to raise additional funds through an equity or debt offering. This flexibility is important, especially
for a young company that is entering into contract negotiations with larger clients because it promotes a
more even-handed discussion.
GRIFFIN SECURITIES EQUITIES RESEARCH 3
4. Unilife Corporation May 23, 2011
BALANCE SHEET# (FISCAL YEAR ENDS JUNE 30 TH
.)
# All data are in thousands.
ASSETS 3/31/2011 6/30/2010
Current Assets
Cash & equivalents 30,188 20,750
Accounts Receivable 6 1,556
Inventory 564 797
Other 430 637
Total Current Assets $ 31,188 $ 23,740
Property & equipment $ 53,562 $ 29,972
Intangible assets 12,959 10,832
Other 489 273
Total Assets $ 98,198 $ 64,817
LIABILITIES
Current Liabilities
Accounts payable $ 3,559 $ 6,044
Debt due 2,297 1,648
Accrued expenses 3,060 2,911
Deferred revenue 2,633 2,188
Total Current Liabilities $ 11,549 $ 12,791
Long-term debt $ 19,362 $ 1,093
Deferred revenue 5,924 6,563
Total Long-Term Liabilities $ 25,286 $ 7,656
Shareholders Equity
Common stock 636 548
Additional paid-in-capital 166,918 122,397
Accumulated Deficit (109,787) (79,650)
Accum. Comprehensive Income 3,596 1,075
Total Shareholders Equity $ 61,363 $ 44,370
Total liabilities & equity $ 98,198 $ 64,817
INCOME STATEMENTS
Our near-term revenue estimates reflect several assumptions. We’ve included the final milestone
payment from the Sanofi industrialization agreement in the fourth quarter of this fiscal year and made a
small provision for sales of the plastic Unitract syringe through distributors. More importantly, we’ve
assumed that Unilife will ship the first 1 million syringes produced to Sanofi in two installments, one in
each of its first two quarters of fiscal 2012. The price of these syringes was set at a significant premium in
the industrialization agreement, probably to cover the absorption of start-up costs and a relatively low,
initial production volume, so revenues will be disproportionately high. Our estimates for the second and
subsequent periods of fiscal 2012 also reflect validation shipments to other drug companies, as well as
modest revenue from outsourced R&D contracts (on the Industrialization fee line). (Note that the
estimates in this report are presented using Unilife’s current fiscal year, rather than the calendar-year
presentation of the last report, dated March 10, 2011.)
We believe the premium price of the syringes shipped to Sanofi will result in reasonable gross margins.
Thereafter, our estimates reflect an assumption that efficiencies are achieved as production volume
grows. Nonetheless, we have not provided for gross margins on syringes to reach optimal levels until
fiscal 2014, when a production line with an annual capacity of 150 million units is operating near its peak
volume. By 2015, the launch of a client-dedicated delivery device should help to raise gross profitability
even further.
GRIFFIN SECURITIES EQUITIES RESEARCH 4
5. Unilife Corporation May 23, 2011
Operating expenses are projected to trend upward as the Company expands its infrastructure to meet its
contractual obligations for the supply of syringes and client-dedicated devices. Depreciation/amortization
related to syringe manufacturing/shipping is included in cost of goods sold starting in 2012 when syringe
shipments commence; the remainder is booked as an operating expense. We believe Unilife will at some
point expand its technology base via licensing deals and/or acquisitions, but we have not included such
opportunities in our projections. Moreover, provisions for income taxes have been made for financial
accounting purposes, even though the Company will be able to limit its cash liabilities in its early years of
profitability through net operating loss carryforwards.
Finally, our share net estimates do not provide for additional external financings, since the timing and size
of such activity is uncertain. However, we have allowed for stock-based compensation and the conversion
of options/warrants in estimating the number of shares outstanding.
VALUATION OF UNIS SHARES
Our 12-month target price is based on the following calculation: We multiplied our 2015 projected
earnings of $1.12 per share by a P/E ratio of 22, resulting in a future price of $22.64, and then discounted
that back three years at an annual rate of 33% to get a 12-month price target of $10.50.
Investors should be aware that validation shipments of syringes and the signing of commercial supply
agreements will likely provide ample near-term milestones to stimulate interest in Unilife. Accordingly, we
believe UNIS shares merit a BUY rating and that they are suitable for growth-oriented investment
portfolios.
GRIFFIN SECURITIES EQUITIES RESEARCH 5
7. Unilife Corporation May 23, 2011
ANNUAL INCOME STATEMENT# (FISCAL YEAR ENDS JUNE 30 TH
.)
2010 2011 2012 2013 2014 2015
Industrialization fees $ 6,318 $ 2,050 $ 2,250 $ 2,300 $ 2,400 $ 2,400
Licensing fees 2,566 2,490 2,560 2,750 3,000 3,250
Product sales & other 2,538 2,860 22,000 114,396 241,987 340,236
Total Revenues $ 11,422 $ 7,400 $ 26,810 $ 119,446 $ 247,387 $ 345,886
Cost of products sold 2,471 2,475 17,200 64,399 122,934 163,810
Gross Profit $ 8,951 $ 4,925 $ 9,610 $ 55,047 $ 124,452 $ 182,076
Operating expenses
R&D expense 4,195 7,345 9,300 9,300 9,500 10,000
SG&A expense 28,696 33,485 29,550 30,000 31,000 32,000
Deprec. & amortization 2,314 3,320 1,000 1,000 1,000 1,000
Total operating costs 35,205 44,150 39,850 40,300 41,500 43,000
Operating profit/(loss) $ (26,254) $ (39,225) $ (30,240) $ 14,747 $ 82,952 $ 139,076
Interest expense (125) (540) (1,150) (1,150) (1,150) (1,150)
Interest income 1,066 530 400 450 450 500
Other income/(expense) (135)
Pretax profit/(loss) $ (25,448) $ (39,235) $ (30,990) $ 14,047 $ 82,252 $ 138,426
Income taxes 4,514 31,636 52,982
Net profit/(loss) $ (25,448) $ (39,235) $ (30,990) $ 9,533 $ 50,616 $ 85,444
Earnings/(loss) per share $ (0.54) $ (0.68) $ (0.49) $ 0.13 $ 0.67 $ 1.12
Shares outstanding 46,837 57,975 63,125 75,000 75,500 76,000
# All figures are in thousands, except per-share data. Estimates are shown in italics. Fiscal 2010 R&D costs exclude a one-time
charge of $4.3 million (paid in stock) for the acquisition of patents pertaining to safety-syringe technology.
GRIFFIN SECURITIES EQUITIES RESEARCH 7
8. Unilife Corporation May 23, 2011
INVESTMENT CONCERNS AND RISKS
For a complete description of risks and uncertainties related to Unilife Corporation’s business,
see Unilife’s Annual Reports, which can be accessed directly from the Company’s website,
www.unilife.com. Potential risks include:
Stock risk and market risk: There is a limited trading market for the Company’s common stock,
partly because it trades on both the NasdaqGM and Australian bourses. There can be no assurance
that an active and liquid U.S. trading market will develop or, if developed, that it will be sustained,
which could limit one’s ability to buy or sell the Company’s common stock at a desired price. Indeed,
the shares may trade at prices on the two exchanges that differ by more than would be determined by
foreign exchange rates alone. Investors should also consider technical risks common to many small-
cap or micro-cap stock investments, such as small float, risk of dilution, dependence upon key
personnel, and the strength of competitors that may be larger and better capitalized.
Competitive risk: The medical device market continues to evolve, and research and development
are expected to continue. Other companies are already established players in the needle & syringe
market and are actively engaged in the development of new safety devices that may directly or
indirectly compete with those being pursued by Unilife. These companies may have substantially
greater research and development capabilities, as well as significantly greater marketing, financial,
and human resources than Unilife.
Products still in development phases: The Company’s ready-to-fill syringes and many other
models are still at a pre-commercialization stage. Such products may appear to be promising, but
may not reach commercialization for various reasons, including failure to achieve regulatory
approvals with customers’ drugs, reliability concerns, and/or the inability to be manufactured at a
reasonable cost. And even if its products are commercialized, there can be no assurance that they
will be accepted, which may prevent the Company from becoming profitable.
Funding requirements: It is difficult to predict Unilife’s future capital requirements. The Company
may need additional financing to continue funding the development of its products and their
production. There is no guarantee that it can secure the desired future capital or, if sufficient capital is
secured, that current shareholders will not suffer significant dilution.
Regulatory risk: There is no guarantee that Unilife’s products will be approved by the U.S. Food and
Drug Administration (FDA) or international regulatory bodies for marketing in the U.S. or abroad.
Patent risk: The medical device industry is one in which patents have not always provided sufficient
protection against competition. Moreover, the sector has had sizable patent disputes that have
resulted in large settlement awards. There can be no assurance that Unilife’s patents will provide
sufficient protection against competitors and that patent litigation will not become a financial burden.
GRIFFIN SECURITIES EQUITIES RESEARCH 8
9. Unilife Corporation May 23, 2011
DISCLOSURES
ANALYST(s) CERTIFICATION: The analyst(s) responsible for covering the securities in this report certify
that the views expressed in this research report accurately reflect their personal views about Unilife
Corporation. (the “Company”) and its securities. The analyst(s) responsible for covering the securities in
this report certify that no part of their compensation was, is, or will be directly or indirectly related to the
specific recommendation or view contained in this research report.
MEANINGS OF RATINGS: Our rating system is based upon 12 to 36 month price targets. BUY describes
stocks that we expect to appreciate by more than 20%. HOLD describes stocks that we expect to change
plus or minus 20%. SELL describes stocks that we expect to decline by more than 20%. SC describes
stocks that Griffin Securities has Suspended Coverage of this Company and price target, if any, for this
stock, because it does not currently have a sufficient basis for determining a rating or target and/or Griffin
Securities is redirecting its research resources. The previous investment rating and price target, if any,
are no longer in effect for this stock and should not be relied upon. NR describes stocks that are Not
Rated, indicating that Griffin Securities does not cover or rate this Company.
DISTRIBUTION OF RATINGS: Currently Griffin Securities has assigned BUY ratings on 93% of companies it covers,
HOLD ratings on 7%, and SELL ratings on 0%. Griffin Securities has provided investment banking services for 11%
of companies in which it has had BUY ratings in the past 12 months and 20% for companies in which it has had
HOLD, NR, or no coverage in the past 12 months or has suspended coverage (SC) in the past 12 months.
MARKET MAKING: Griffin Securities does not maintain a market in the shares of this Company or any
other Company mentioned in the report.
FORWARD-LOOKING STATEMENTS: This Report contains forward-looking statements, which involve
risks and uncertainties. Actual results may differ significantly from such forward-looking statements.
Factors that might cause such a difference include, but are not limited to, those discussed in the “Risk
Factors” section in the SEC filings available in electronic format through SEC Edgar filings at
www.SEC.gov on the Internet.
DISCLOSURES FOR OTHER COMPANIES MENTIONED IN THIS REPORT: To obtain applicable
current disclosures in electronic format for the subject companies in this report, please refer to SEC Edgar
filings at www.SEC.gov. In particular, for a description of risks and uncertainties related to subject
companies’ businesses in this report, see the “Risk Factors” section in the SEC filings.
PRICE CHART – 2-year
BUY
BUY
BUY
Source: Big Charts.com
Initial Coverage (Australian exchange): 8/19/2009; share price, A$0.59; rating, BUY; 12-month price
target, A$3.65. Update report: 1/29/2010; share price, A$1.45; rating, BUY; 12-month price target,
A$2.75. Update report (NasdaqGM): 3/31/2010; share price, $5.93; rating, BUY; 12-month price target,
$15.00; Update report: 3/10/2011, share price, $4.25; rating, BUY; 12-month price target, $10.50;
5/20/11; share price: $5.18; rating, BUY; 12-month price target, $10.50.
GRIFFIN SECURITIES EQUITIES RESEARCH 9
10. Unilife Corporation May 23, 2011
The price chart for UNIS shares trading on the NasdaqGM market merits a brief discussion. Because
investors who held the original Australian equity had to ask to receive the U.S. listed stock, there were
relatively few shares available for trading in the month of February 2010. As a result, the price was
unusually volatile. By March, a larger number of shares were available for trading on the NasdaqGM, and
the volatility subsided, even though trading activity was uneven.
COMPENSATION OR SECURITIES OWNERSHIP: The analyst(s) responsible for covering the securities
in this report receive compensation based upon, among other factors, the overall profitability of Griffin
Securities, including profits derived from investment banking revenue. The analyst(s) that prepared the
research report did not receive any compensation from the Company or any other companies mentioned
in this report in connection with the preparation of this report. Keith A. Markey the analyst responsible for
covering the securities in this report, currently owns common stock in the Company, and in the future the
analyst(s) may from time to time engage in transactions with respect to the Company or other companies
mentioned in the report. Griffin Securities from time to time in the future may request expenses to be paid
for copying, printing, mailing and distribution of the report by the Company and other companies
mentioned in this report. Griffin Securities expects to receive, or intends to seek, compensation for
investment banking services from the Company in the next three months.
GENERAL: Griffin Securities, Inc. (“Griffin Securities”) a FINRA (formerly known as the NASD) member
firm with its principal office in New York, New York, USA is an investment banking firm providing
corporate finance, merger and acquisitions, brokerage, and investment opportunities for institutional,
corporate, and private clients. The analyst(s) are employed by Griffin Securities. Our research
professionals provide important input into our investment banking and other business selection
processes. Our salespeople, traders, and other professionals may provide oral or written market
commentary or trading strategies to our clients that reflect opinions that are contrary to the opinions
expressed herein, and our proprietary trading and investing businesses may make investment decisions
that are inconsistent with the recommendations expressed herein.
Griffin Securities may from time to time perform corporate finance or other services for some companies
described herein and may occasionally possess material, nonpublic information regarding such
companies. This information is not used in preparation of the opinions and estimates herein. While the
information contained in this report and the opinions contained herein are based on sources believed to
be reliable, Griffin Securities has not independently verified the facts, assumptions and estimates
contained in this report. Accordingly, no representation or warranty, express or implied, is made as to,
and no reliance should be placed on, the fairness, accuracy, completeness or correctness of the
information and opinions contained in this report.
The information contained herein is not a complete analysis of every material fact in respect to any
company, industry or security. This material should not be construed as an offer to sell or the solicitation
of an offer to buy any security in any jurisdiction where such an offer or solicitation would be illegal. We
are not soliciting any action based on this material. It is for the general information of clients of Griffin
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material is based on information that we consider reliable, but we do not represent that it is accurate or
complete, and it should not be relied on as such. The information contained in this report is subject to
change without notice and Griffin Securities assumes no responsibility to update the report. In addition,
regulatory, compliance, or other reasons may prevent us from providing updates.
GRIFFIN SECURITIES EQUITIES RESEARCH 10