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| PYMX.OB > SEC Filings for PYMX.OB > Form 10-K on 23-Mar-2009 | All Recent SEC Filings |
23-Mar-2009
Annual Report
The following discussion and analysis provides information that we believe is
relevant to an assessment and understanding of our results of operations for the
years ended December 31, 2008, 2007 and 2006, and financial condition for the
years ended December 31, 2008 and 2007.
Critical Accounting Policies and Practices
The preparation of our Consolidated Financial Statements in conformity with
accounting principles generally accepted in the United States requires
management to adopt critical accounting policies and to make estimates and
assumptions that affect the amounts reported in our Consolidated Financial
Statements and accompanying notes. These critical accounting policies and
estimates have been reviewed by our Audit Committee. The principal items in our
Consolidated Financial Statements reflecting critical accounting policies or
requiring significant estimates and judgments are as follows:
Stock-based compensation
From our inception, August 8, 2002, we adopted the fair value recognition
provisions of Statement of Financial Accounting Standards ("SFAS") No. 123,
Accounting for Stock-Based Compensation and have, since inception, recognized
equity compensation expense over the requisite service period. Beginning
January 1, 2006, we adopted SFAS No. 123(R), Share-based Payment using the
modified-prospective transition method. There was no significant impact from
switching from SFAS No. 123 to SFAS No. 123(R). Since inception, we have used
the Black-Scholes formula to estimate the fair value of stock options and have
elected to continue to estimate the fair value of stock options using the
Black-Scholes formula. The volatility and expected term assumptions have the
most significant effect on the results obtained from the Black-Scholes
option-pricing model. We have to date assumed that stock options have an
expected life of five years, representing about half of their contractual life,
and assumed Common Stock volatility of between 41% and 75%. Higher estimates of
volatility and expected life of the option increase the value of an option and
the resulting expense. Given the absence of an active market for our Common
Stock in prior periods, the fair value of our Common Stock has periodically been
estimated using several criteria, including progress and milestones achieved in
our research activities along with the price per share of our preferred and
Common Stock offerings.
Results of Operations
Year ended December 31, 2008 compared to year ended December 31, 2007
Since inception, our only revenues have been from grants and other research
arrangements. Grant and research revenues were $1,066,000 and $1,126,000 for the
years ended December 31, 2008 and 2007, respectively. The decrease in grant and
research revenue was attributable to the timing of expenses and related funds
received in connection with our advanced technology grant from the National
Institute of Health, or NIH, in support of our development of our i.v.
antibiotic product candidate and our heptagonist product candidate. We currently
have $7,000 remaining available under these grants.
We incurred research and development expenses of $7,401,000 and $9,328,000 for
the years ended December 31, 2008 and 2007, respectively. The decrease was the
result of the delay and scale-back of certain research and delay of certain
clinical development costs during 2008. With the closing of our third quarter
financing activities, costs to bring both PMX-30063 and PMX-60056 through Phase
1 development were prioritized and deployed. Research and development costs
include $440,000 and $323,000 related to stock-based compensation expense for
the years ended December 31, 2008 and 2007, respectively. Pending timely and
adequate additional funding, we expect our research and development costs to
increase in the second half of 2009 as a result of increased staff hiring in
connection with the start of preparation for Phase 2 studies for our PMX-30063
and PMX-60056 product candidates.
General and administrative expenses were $4,875,000 and $4,473,000 for the years
ended December 31, 2008 and 2007, respectively. The overall increase was mostly
attributable to increased legal costs and personnel costs. General and
administrative costs include $964,000 and $936,000 related to stock-based
compensation expense for the years ended December 31, 2008 and 2007,
respectively.
Interest income and other expenses were $224,000 and $511,000 for the years
ended December 31, 2008 and 2007, respectively. The decrease was due to
decreased interest rates on our cash, cash equivalent and investment balances.
Cash Flows
Operating Activities. Cash used in operating activities during the year ended
December 31, 2008 increased to $10,926,000 as compared to $8,266,000 used for
the year ended December 31, 2007. The increase was primarily due to increased
general and administrative expenses and decreased current liabilities.
Investing Activities. Cash used for investing activities represents cash paid
for purchases of investments and property and equipment, net of maturities of
investments. During the year ended December 31, 2008 and 2007, we purchased
$9,553,000 and $9,880,000 of investments, respectively. During the year ended
December 31, 2008 and 2007, maturities of our investments were $5,700,000 and
$12,098,000, respectively. During the years ended December 31, 2008 and 2007,
property and equipment purchases were $0 and $266,000, respectively.
Financing Activities. We have financed our operating and investing activities
primarily from the proceeds from the sale of equity securities. During the years
ended December 31, 2008 and 2007, we received $16,966,000 and $2,558,000,
respectively, in net proceeds of such issuances of equity securities.
Additionally, during 2008 and 2007 we received $214,000 and $184,000,
respectively from the exercise of stock options.
Year ended December 31, 2007 compared to year ended December 31, 2006
Grant and research revenues were $1,126,000 and $821,000 for the years ended
December 31, 2007 and 2006, respectively. The increase in grant and research
revenue was attributable to funds received in connection with our advanced
technology grant from the National Institute of Health, or NIH, in support of
our development of our i.v. antibiotic product candidate, which commenced in
April 2006.
We incurred research and development expenses of $9,328,000 and $3,306,000 for
the years ended December 31, 2007 and 2006, respectively. The increase was the
result of increased headcount and outside laboratory research costs associated
with our preclinical development, GMP compliant manufacturing and GLP compliant
toxicology, safety pharmacology and genotoxicity studies for PMX-60056 and
PMX-30063 planned for 2008. Research and development costs include $323,000 and
$205,000 related to stock-based compensation expense for the years ended
December 31, 2007 and 2006, respectively.
General and administrative expenses were $4,473,000 and $4,174,000 for the years
ended December 31, 2007 and 2006, respectively. The increase was the result of
facility, investor relations and legal costs. General and administrative costs
include $936,000 and $934,000 related stock-based compensation expense for the
years ended December 31, 2007 and 2006, respectively.
Interest income and other expenses were $511,000 and $693,000 for the years
ended December 31, 2007 and 2006, respectively. The decrease was a result of our
decreased average cash and investment balances along with declining interest
rates.
Cash Flows
Operating Activities. Cash used in operating activities during the year ended
December 31, 2007 increased to $8,266,000 as compared to $4,319,000 used for the
year ended December 31, 2006. The increase is attributed primarily to increased
research and development spending and increased general and administrative
expenses.
Investing Activities. Cash used for investing activities represents cash paid
for purchases of investments and property and equipment, net of maturities of
investments. During the year ended December 31, 2007 and 2006, we purchased
$9,880,000 and $10,810,000 of investments, respectively. During the year ended
December 31, 2007 and 2006, maturities of our investments were $12,098,000 and
$5,000,000, respectively. During the years ended December 31, 2007 and 2006,
property and equipment purchases were $266,000 and $274,000, respectively.
Financing Activities. We have financed our operating and investing activities
primarily from the proceeds from the sale of equity securities. During the years
ended December 31, 2007 and 2006, we received $2,558,000 and $3,720,000,
respectively, in net proceeds of such issuances of equity securities.
Additionally, during 2007 we received $184,000 from the exercise of stock
options.
Liquidity and Capital Resources
As of December 31, 2008 and December 31, 2007, we had cash and investment
balances of approximately $15,106,000 and $8,903,000, respectively, and total
liabilities of approximately $2,934,000 and $4,588,000, respectively. The
increase in our cash balance was attributable to net proceeds of $16,966,000
received from our third quarter 2008 financing activities, which we believe is
sufficient to fund our operations for at least the next twelve months as
described below.
The global financial markets have been and continue to be in turmoil, with
extreme volatility in the equity and credit markets and with some financial and
other institutions experiencing significant financial distress. In addition,
neither our access to nor the value of our cash equivalents or short-term
investments have been negatively affected by the recent liquidity problems of
financial institutions. Although we have attempted to be prudent in our
investment strategy and in funding our anticipated near term liquidity needs, it
is not possible to predict how the financial market turmoil and the
deteriorating economic conditions may affect our financial position.
These and any future financial institution failures could cause losses to the
extent cash amounts or the values of securities exceed government deposit
insurance limits, and could restrict our access to the public equity and debt
markets. In particular, the cost of raising money in the debt and equity capital
markets has increased substantially while the availability of funds from those
markets has diminished significantly. Also, as a result of concern about the
stability of financial markets generally and the solvency of counterparties
specifically, the cost of obtaining money from the credit markets has increased
as many lenders and institutional investors have increased interest rates,
enacted tighter lending standards and reduced and, in some cases, ceased to
provide funding to borrowers. Low valuations and decreased appetite for equity
investments, among other factors, may make the equity markets difficult to
access on acceptable terms or unavailable altogether.
We are a development stage company and have not experienced significant revenue
generating activities since our formation. We reached a positive working capital
position for the first time in the fourth quarter of 2005 as a result of our
financing activities. We have incurred operating losses for each year since our
inception in 2002. To achieve operating profits, we, alone or with others, must
successfully identify, develop and market product candidates. Our principal
activities, from the beginning of our development stage, have been
organizational matters, issuance of stock, product research and development,
fund raising and market research.
In the near-term, we expect to continue to incur significant and increasing
operating losses as a result of the research and development expenses we expect
to incur in developing our product candidates and the general and administrative
expenses we incur as a reporting company under the Securities Exchange Act of
1934, as amended. Additionally, we do not expect to generate any revenues from
sources other than research grants for the foreseeable future.
We believe that our current cash and investment balances will fund our planned
Phase 1 studies for PMX-30063 and PMX-60056 and can fund our operations for at
least the next twelve months. Our current cash and investment balances are not
sufficient to fund the Phase 2 development of either of these product
candidates. We plan to seek additional funding during 2009 in one or more
financings. However, if we are unable to secure adequate additional funding by
the end of the second quarter of 2009, we will delay, scale-back or eliminate
certain of our future research, drug discovery or development activities or
certain other aspects of our operations and our business until such time as we
are successful in securing adequate additional funding. In the absence of
adequate additional funding, we believe that we have the ability to scale our
operations, however, in doing so our current cash and investment balances can
only fund our operations into the second half of 2010. Our short and long-term
capital requirements depend upon a variety of factors, including market
acceptance for our technologies and product candidates and various other
factors, many of which we cannot control, including:
• success of our clinical trials for PMX-30063 and PMX-60056;
• continued progress of and increased spending related to our research and development activities, including our plan to hire additional research and development employees;
• the conditions in the capital markets and the biopharmaceutical industry that make raising capital or entering into strategic arrangements difficult and expensive;
• progress with preclinical experiments and clinical trials;
• ongoing general and administrative expenses related to our being a reporting company;
• the cost, timing, and results of regulatory reviews and approvals;
• the maintenance of our existing licenses with the Penn and UMass;
• the success, timing, and financial consequences of any future collaborative, licensing and other arrangements that we may establish;
• the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights;
• the costs of commercializing any of our other product candidates;
• technological and market developments;
• the cost of manufacturing development; and
• timing and volume of sales of products for which we obtain marketing approval.
We expect to seek additional funds through equity or debt financing,
collaborative or other arrangements with corporate partners, and from other
sources. For instance, we may actively seek more funding through government
grants and contracts. We may not be able to obtain any additional financing on
terms acceptable to us, if at all, or we may not raise as much as we expect. If
adequate additional funds are not available when required, we will have to
delay, scale-back or eliminate certain of our future research, drug discovery or
development activities or certain other aspects of our operations and our
business will be materially and adversely affected.
We are subject to many risks associated with development-stage businesses,
including the above-discussed risks associated with the ability to raise
capital. Please see the section entitled "Risk Factors" for more information
regarding risks associated with our business.
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements as defined in Item 303(a)(4)
of Regulation S-K.
Commitments and Contingencies
As described above, we believe our current cash and investment balances are
adequate to fund operations, including the following commitments and
contingencies, at least for the next twelve months. If we are unable to secure
adequate additional funding during the first half of 2009, we will delay,
scale-back or eliminate certain of our future research, drug discovery or
development activities or certain other aspects of our operations and our
business until such time as we are successful in securing adequate additional
funding.
Capital Lease
We have entered into lease agreements for laboratory equipment. The initial
obligation under these capital leases was $331,000. The value of the laboratory
equipment acquired in connection with these leases was $398,000 and the
depreciation associated with these assets is included along with that of other
owned property and equipment. These equipment leases have terms of up to three
years, at interest rates ranging from 9.5% to 11.5% and contain bargain purchase
options. In connection with these capital leases, we will pay $108,000 during
2009, $4,000 of which will be for interest. These capital leases end during
2009.
Operating Lease
In June 2006, we entered into a lease agreement for 24,223 square feet of
combined office and laboratory space located in Radnor, Pennsylvania. The
initial term of the lease is 12 years. Payments under the lease commenced on
December 1, 2006. Our future minimum lease payments under this non-cancelable
operating lease are as follows (in thousands):
Operating Leases
2009 $ 497
2010 $ 589
2011 $ 667
2012 $ 686
2013 $ 705
Thereafter $ 3,610
Total minimum lease payments $ 6,754
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Prior to the commencement of our current operating lease for our Radnor
Facility, we leased approximately 3,500 square feet of combined office and
laboratory space on a month-to-month basis in Philadelphia, Pennsylvania. Rent
expense was $598,000, $598,000 and $559,000 and $1,877,000 for the years ended
December 31, 2008, 2007, and 2006, and for the period from August 8, 2002
(Inception) to December 31, 2008, respectively.
Patent License Agreements
University of Pennsylvania. In January 2003, we entered into a Patent License
Agreement with Penn. Under the terms of the agreement, we were granted an
exclusive, worldwide royalty-bearing license to make and sell products utilizing
seven of Penn's issued or pending patents for the life of such patents. One
issued patent and five patent applications cover the composition of matter on
antimicrobial compounds, including small molecules, oligomers and polymers. One
patent application covers the composition and use of polycationic compounds for
treating cancer. If a change-of-control event occurs, in which we transfer the
license to these patents to a third party or we are acquired by another company,
we are required to pay a 3% royalty on the gross sales for licensed products
that are sold as pharmaceuticals and a 1.5% royalty on products sold as coatings
for use in medical devices. We are permitted to sublicense the patents provided
that (a) the sublicensee is prohibited from further licensing of the patents and
(b) the sublicensee is subject to all of the terms of the original license
granted to us. In addition, we are required to share with Penn any consideration
we receive from sublicensing our patents to a third party.
University of Massachusetts. In January 2004, we entered into a five-year
sponsored research agreement with UMass. Under the terms of this agreement, we
have the exclusive option to license any intellectual property that may be
generated by Dr. Gregory Tew pursuant to research sponsored under the agreement.
We may exercise this option by issuing 7,500 shares of our Common Stock to UMass
for each $100,000 of research conducted by Dr. Tew. If we exercise this option,
we are also required to reimburse UMass for direct patent costs incurred by it
for the patents licensed by us. During 2007, we issued 12,500 shares to UMass in
connection with this agreement. We sponsored $36,000 and $107,000, $118,000 of
Dr. Tew's research for 2008, 2007 and 2006, respectively.
Other
Agreements with Employees. We have entered into employment agreements with
various executives. These agreements provide for severance arrangements and
accelerated vesting of equity compensation awards in the event that the
executive is terminated by us other than for cause or disability or if the
executive resigns for good reason.
Credit Line. In April 2006, we entered into a line of credit agreement with a
financial institution. This line of credit provides for monthly interest-only
payments at a variable per annum rate of 3% plus the 30-day LIBOR rate. The
amount available under this line of credit ranges from 85% to 92% of cash and
investments pledged as collateral, based upon the amount and security type.
There is currently no outstanding balance on this line of credit. In June 2006,
we entered into a letter of credit agreement with the same financial institution
to secure our payment obligations under our facility operating lease. This
letter of credit is for $1,400,000, expires on December 1, 2009 and is secured
by our credit line.
Recently Issued Accounting Pronouncements
In September 2006, the Financial Accounting Standards Board (or "FASB") issued
Statement of Financial Accounting Standards (or "SFAS") No. 157, Fair Value
Measurements ("SFAS 157"). SFAS 157 clarifies the definition of fair value,
establishes a framework for measuring fair value and expands disclosures on fair
value measurements. SFAS 157 was effective for financial statements issued for
fiscal years beginning after November 15, 2007 and interim periods within those
fiscal years; however, the FASB did provide a one-year deferral for the
implementation of SFAS 157 for nonfinancial assets and liabilities.
SFAS 157 establishes a valuation hierarchy for disclosure of the inputs to
valuation used to measure fair value. This hierarchy prioritizes the inputs into
three broad levels as follows. Level 1 inputs are quoted prices (unadjusted) in
active markets for identical assets or liabilities. Level 2 inputs are quoted
prices for similar assets and liabilities in active markets or inputs that are
observable for the asset or liability, either directly or indirectly through
market corroboration, for substantially the full term of the financial
instrument. Level 3 inputs are unobservable inputs based on management's own
assumptions used to measure assets and liabilities at fair value. A financial
asset or liability's classification within the hierarchy is determined based on
the lowest level input that is significant to the fair value measurement. The
adoption of SFAS 157 did not have any impact on our consolidated financial
statements.
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