Liquidity and Capital Resources
We have funded our operations principally with the proceeds of $54.5 million
from a series of five preferred stock offerings and one issue of convertible
notes over the period 2000 through 2003, the net proceeds of $54.3 million from
our initial public offering in October 2003, and a private placement of common
stock for net proceeds of $25.8 million in April 2005. In addition, we have
received funding of $8.0 million and $28.25 million from GlaxoSmithKline and Par
Pharmaceutical, respectively, as a result of collaboration agreements for the
development of new products. Since July 2004, we have also received cash from
sales of our Keflex products. We also received a $1.0 million advance payment in
2005 from a potential buyer of our Keflex brand, which we retained as the sale
was not completed.
Cash and Marketable Securities
At December 31, 2005, unrestricted cash, cash equivalents and marketable
securities were $29.0 million compared to $30.1 million at December 31, 2004.
As of December 31,
2005 2004
Cash and cash equivalents $ 18,117,000 $ 10,396,000
Marketable securities 11,314,000 19,656,000
Total $ 29,431,000 $ 30,052,000
Restricted cash at December 31, 2005 of approximately $0.4 million will become
unrestricted during 2006 and provide additional liquidity.
Our cash and cash equivalents are highly-liquid investments with a maturity of
90 days or less at date of purchase and consist of time deposits, investments in
money market funds with commercial banks and financial institutions, and
commercial paper of high-quality corporate issuers. Our marketable securities
are also highly-liquid investments and are classified as available-for-sale, as
they can be utilized for current operations. The Company's investment policy
requires the selection of high-quality issuers, with bond ratings of AAA to
A1+/P1. The Company's objective is to maintain its investment portfolio at an
average duration of approximately one year.
Also, we maintain cash balances with financial institutions in excess of insured
limits. We do not anticipate any losses with respect to such cash balances.
Cash Flow
The following table summarizes our sources and uses of cash and cash equivalents
for fiscal years ending December 31, 2005, 2004, and 2003.
Year Ended December 31,
2005 2004 2003
Net cash used in operating activities $ (24,890,000 ) $ (15,487,000 ) $ (11,084,000 )
Net cash provided by (used in) investing
activities 7,676,000 (11,721,000 ) (36,413,000 )
Net cash provided by financing activities 24,935,000 153,000 80,887,000
Net increase (decrease) in cash and cash
equivalents $ 7,721,000 $ (27,055,000 ) $ 33,390,000
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Operating Activities
Net cash used in operating activities for the three years ended December 31,
2005 is presented in the following table, which displays cash received and cash
disbursed by major element.
Year Ended December 31,
Operating Activities 2005 2004 2003
Cash receipts:
Cash received from product sales $ 5,159,000 $ 2,230,000 $ -
Cash received from collaboration partners 14,250,000 17,000,000 5,000,000
Interest income received and other 1,622,000 2,185,000 581,000
Total cash receipts 21,031,000 21,415,000 5,581,000
Cash disbursements:
Cash paid for employee compensation and benefits 11,432,000 10,401,000 6,826,000
Cash paid to vendors, suppliers, and other 34,489,000 26,501,000 9,839,000
Total cash disbursements 45,921,000 36,902,000 16,665,000
Net cash used in operating activities $ (24,890,000 ) $ (15,487,000 ) $ (11,084,000 )
Cash received from product sales in 2005 of $5.2 million significantly exceeded
product sales cash receipts in 2004 of $2.2 million, as the 2004 amount reflects
only about a half year of activity. Cash received from collaboration partners
relates to our previous collaboration agreements with Par Pharmaceutical for
amoxicillin PULSYS and with GlaxoSmithKline for amoxicillin/clavulanate
development. We received $14.25 million and $14.0 million in 2005 and 2004,
respectively, from Par and $3.0 million and $5.0 million in 2004 and 2003,
respectively, from GSK. The increase in cash disbursements from 2003 to 2005
reflects the growth in the Company's average headcount and the significant costs
involved in the Company's Phase III clinical trials in 2004 and 2005.
Investing Activities
Net cash used in investing activities for the three years ended December 31,
2005 is presented in the following table, which displays cash received and cash
disbursed by major element.
Year Ended December 31,
Investing Activities 2005 2004 2003
Cash receipts:
Sale of marketable securities, net of
purchases $ 8,176,000 $ 6,582,000 $ -
Advance payment received for potential sale of
Keflex 1,000,000 - -
Sale of fixed assets, restricted cash and
other 423,000 - 830,000
Total cash receipts 9,599,000 6,582,000 830,000
Cash disbursements:
Purchase of marketable securities - - 27,858,000
Purchase of Keflex brand rights - 11,206,000 -
Property and equipment purchases and deposits 1,923,000 6,960,000 9,047,000
Change in restricted cash and other - 137,000 338,000
Total cash disbursements 1,923,000 18,303,000 37,243,000
Net cash used in investing activities $ 7,676,000 $ (11,721,000 ) $ (36,413,000 )
The most significant investing activities in 2005 included net purchases and
sales of marketable securities of $8.2 million, receipt of a $1.0 million
advance payment pursuant to the potential sale of Keflex assets (which we
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retained, as the agreement-in-principle expired without the sale of the
business), and purchases of and deposits on property and equipment of
$1.9 million.
Net cash used in investing activities during the year ended December 31, 2004
was $11.7 million. The most significant investing activities included the
acquisition of Keflex intangibles for $11.2 million, and purchases of and
deposits on property and equipment of $7.0 million. Net purchases and sales of
marketable securities provided $6.6 million during the period.
Net cash used in investing activities during fiscal 2003 was $36.4 million. The
Company invested $27.9 million of its IPO proceeds in marketable securities,
representing securities with maturities exceeding 90 days. The Company also
spent $9.0 million (excluding $1.6 million of accrued construction costs) on the
acquisition of property and equipment, primarily for the fit-out of its new
corporate, research and development facility in Germantown, Maryland. An
additional $338,000 of cash was required by the Company's equipment financing
terms to be placed in financial institutions on a restricted basis as additional
loan collateral. Partially offsetting these cash outflows was the receipt of
$830,000 in cash as part of the tenant improvement allowance for our corporate,
research and development facility; this amount will be amortized as a reduction
in rent expense over the term of the lease.
Financing Activities
Net cash provided by financing activities for the three years ended December 31,
2005 is presented in the following table, which displays cash received and cash
disbursed by major element.
Year Ended December 31,
Financing Activities 2005 2004 2003
Cash receipts:
Cash received from private placement $ 25,844,000 $ - $ -
Cash received from lines of credit - 1,390,000 1,346,000
Cash received from initial public offering - - 54,312,000
Cash received from preferred stock and notes - - 25,775,000
Cash received from exercise of stock options 101,000 16,000 91,000
Total cash receipts 25,945,000 1,406,000 81,524,000
Cash disbursements:
Cash paid for debt payments 1,010,000 1,253,000 637,000
Total cash disbursements 1,010,000 1,253,000 637,000
Net cash provided by financing activities $ 24,935,000 $ 153,000 $ 80,887,000
The major financing activity in 2005 was the private placement of common stock,
which provided $25.8 million net of issuance costs. Additionally, repayments on
lines of credit totaled $1.0 million during the period.
Net cash provided by financing activities in 2004 was $0.2 million. The major
financing activities included loan draws of $1.4 million for equipment financing
in connection with the fit-out of the Company's new corporate, research and
development facility and repayments of $1.2 million on the Company's existing
borrowings.
Net cash from financing activities for fiscal 2003 was $80.9 million. The major
financing activities included $5.0 million from the issue of convertible notes
in March 2003, $20.8 million from the closing of the Series E preferred stock
financing round in July 2003, and $54.3 million from the closing of Company's
initial public offering of its common stock in October 2003. The Company also
obtained $1.3 million from draws under its lines of credit for equipment
financing.
Borrowings
We are a party to four credit facilities for an aggregate amount of $5.9 million
used to finance the purchase of equipment and to one loan agreement for $75,000
with a local government development fund. The credit facilities
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have no amounts available for new borrowings. Of the total $5.9 million amount,
$1.6 million was outstanding as of December 31, 2005, as summarized in the
following table:
As of December 31, 2005
Remaining
Amount Amount
Debt Obligations Interest Rates Outstanding Available
Fixed rate borrowings 5.00% - 11.62% $ 190,000 $ -
LIBOR or Fixed Cost of Funds
Variable rate borrowings plus 250 - 280 basis points 1,377,000 -
Totals $ 1,567,000 $ -
We do not currently hedge variable rate borrowings.
Stock Issuances
In April 2005, we completed a private placement of 6,846,735 shares of our
common stock at a price of $3.98 per share and warrants to purchase a total of
2,396,357 shares of common stock at an exercise price of $4.78 per share,
resulting in net proceeds, after commissions and expenses, of $25.8 million. The
warrants are exercisable for five years.
Contractual Obligations
The following table summarizes our contractual obligations at December 31, 2005
and the effects such obligations are expected to have on our liquidity and cash
flows in future periods.
Payments Due by Period
After
Contractual Obligations (1), (2) Total 2006 2007 2008 2009 2010 2010
(In thousands)
Short and long-term debt (includes
interest) $ 1,636 $ 949 $ 636 $ 51 $ - $ - $ -
Minimum purchase commitments (3) 1,239 1,239 - - - - -
Operating lease obligations 16,033 2,126 2,080 2,139 2,156 2,214 5,318
Total contractual cash obligations $ 18,908 $ 4,314 $ 2,716 $ 2,190 $ 2,156 $ 2,214 $ 5,318
Other commercial commitments(4) $ 4,545 $ 4,545 $ - $ - $ - $ - $ -
(1) This table does not include potential royalty payments, at a rate of 10% of
sales value, to Eli Lilly and Company, which may be due on product line
extensions of Keflex. Any such royalties cannot be estimated at this time.
(2) This table does not include a contingent liability to Par Pharmaceutical
under our amoxicillin development and commercialization agreement that was
terminated by Par in August 2005. Under certain circumstances, the
termination clauses of the agreement may entitle Par to receive a share of
future net profits, if any, up to one-half of Par's total $23.25 million
investment in the development of certain amoxicillin PULSYS products, should
a product covered by the agreement be successfully commercialized.
Accordingly, we retained $11.625 million of deferred revenue in recognition
of this contingent liability to Par.
(3) We have entered into a manufacturing agreement with Ceph International for
the manufacturing of our Keflex products. This agreement contains a provision
for minimum purchase requirements.
(4) We have entered into other contractual agreements in connection with
developing our products and technology and to perform clinical trials. This
amount represents the remaining contractual amount due for our on-going
Phase III clinical trial. Although the contract could be cancelled by us, in
which case we would be liable to the
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vendor for work performed to the date of cancellation, it is our intent to
complete the clinical trial at the remaining cost of approximately
$4.5 million.
In addition to the contractual obligations in the above table, the Company may
incur funding liabilities for obligations which it enters into on a
discretionary basis. These discretionary obligations could include additional
facilities or equipment, investments in new technologies or products,
acquisitions, funding of clinical trials, or similar events. As of December 31,
2005, we are not committed to fund any further pre-production development work
at the Clonmel facility; however, should our Amoxicillin PULSYS Phase III trial
be successful, our intention would be to fund approximately $2.8 million of
additional development work at Clonmel, primarily in late 2006 and early 2007,
to prepare for commercial production of Amoxicillin PULSYS.
During fiscal 2005 we spent approximately $1.4 million for capital expenditures,
primarily for equipment purchased for use at third-party manufacturing
facilities, as well as for use in our research and development facility in
Germantown, Maryland.
Off-Balance Sheet Arrangements
We have not entered into any transactions, agreements or other contractual
arrangements that meet the definition of off-balance sheet arrangements, with
the exception of our private placement of common stock and warrants in April
2005. Warrants are instruments that meet the definition of a derivative under
SFAS 133, although they qualify for the scope exception under paragraph 11 of
SFAS 133. In the private placement, warrants were issued to purchase a total of
2,396,357 shares of common stock at an exercise price of $4.78 per share.
Prospective Information
We expect to incur losses from operations for the foreseeable future. We expect
to continue to incur substantial research and development expenses in 2006,
including expenses related to preclinical testing and clinical trials. We expect
that our selling and marketing expenses will increase in 2006, assuming FDA
approval of our Keflex line extension products and commercial launch of the new
products. If the launch is successful, we will collect cash on these incremental
sales which would offset some or all of our increased selling and marketing
expenses in 2006. We believe the Keflex line extension products have the
potential to generate significant cash in excess of selling costs in 2007. We
also expect a limited window of opportunity for these products, approximating 18
to 24 months, should generic pharmaceutical companies decide to compete with our
line extension products.
Our future capital requirements will depend on a number of factors, including
the continued progress of our research and development of product candidates,
the timing and outcome of regulatory approvals, payments received or made under
any future collaborative agreements, the costs involved in preparing, filing,
prosecuting, maintaining, defending and enforcing patent claims and other
intellectual property rights, the acquisition of licenses to new products or
compounds, the status of competitive products, the availability of financing and
our or our partners' success in developing markets for our product candidates.
After receiving the results in June and July 2005 of our unsuccessful pediatric
and adult Phase III trials, we conducted an intensive analysis of the data with
the intent to reach a conclusion regarding the future of our Amoxicillin PULSYS
development program. We also considered how to maximize the future value of our
Keflex franchise. Each of these outstanding matters has significant implications
for our anticipated level of future spending and our capital available to fund
future operations. In September 2005, we announced our decisions regarding these
outstanding matters. We decided to continue our Amoxicillin PULSYS development
program and to conduct a new Phase III clinical trial. We also decided to
investigate the potential sale of the Keflex brand in order to increase our
level of unrestricted cash on hand.
In July and September 2005, we reduced our workforce by approximately 38% as
part of an initiative to reduce operating expenses. The cost reduction will
enhance our ability to rely on our existing resources to fund our operations
over the next year. We believe that our cash, cash equivalents and marketable
securities of $29.4 million on hand as of December 31, 2005, together with the
effect of the reduction in our workforce in the third quarter of 2005 and
product revenue collections in 2006 from sales of our currently-marketed Keflex
products, provide us with enough capital resources to finance our ongoing
operations, including our new Phase III clinical trial, until at least
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the first quarter of 2007. We will continue to balance our pace of development
with our funding position, and we anticipate the resources described above will
be sufficient to fund our planned operating expenses, debt repayments and
capital equipment requirements for at least the next 12 months, barring
unforeseen developments. This forecast is a forward-looking statement that
involves risks and uncertainties, and actual results could vary.
We have no unused credit facility or other committed sources of capital. To the
extent our capital resources are insufficient to meet future capital
requirements, we will need to raise additional capital, incur indebtedness, or
consider the sale of company assets in order to fund our operations. There can
be no assurance that additional debt or equity financing will be available on
acceptable terms, if at all. If adequate funds are not available, we may be
required to delay, reduce the scope of or eliminate our research and development
programs, reduce our commercialization efforts, effect changes to our facilities
or personnel, or obtain funds through arrangements with collaborative partners
or others that may require us to relinquish rights to certain product candidates
that we might otherwise seek to develop or commercialize independently. Any
future funding may dilute the ownership of our equity investors.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in "Business" and "Management's Discussion and
Analysis of Financial Condition and Results of Operations," are forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933, as
amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The
forward-looking statements are based on our current intent, belief and
expectations. These statements are not guarantees of future performance and are
subject to certain risks and uncertainties that are difficult to predict. Actual
results may differ materially from these forward-looking statements because of
our unproven business model, our dependence on new technologies, the uncertainty
and timing of clinical trials, our ability to develop and commercialize
products, our dependence on collaborators for services and revenue, our
substantial indebtedness and lease obligations, our changing requirements and
costs associated with planned facilities, intense competition, the uncertainty
of patent and intellectual property protection, our dependence on key management
and key suppliers, the uncertainty of regulation of products, the impact of
future alliances or transactions and other risks described in this filing and
our other filings with the Securities and Exchange Commission. Existing and
prospective investors are cautioned not to place undue reliance on these
forward-looking statements, which speak only as of today's date. We undertake no
obligation to update or revise the information contained in this announcement
whether as a result of new information, future events or circumstances or
otherwise.
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