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Quotes & Info
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| CPIX > SEC Filings for CPIX > Form 10-Q on 12-Nov-2009 | All Recent SEC Filings |
12-Nov-2009
Quarterly Report
growth strategies with the early-stage drug development activities of Cumberland
Emerging Technologies (CET), our majority-owned subsidiary. CET partners with
universities and other research organizations to cost-effectively develop
promising, early-stage product candidates, which Cumberland has the opportunity
to commercialize.
We were incorporated in 1999 and have been headquartered in Nashville, Tennessee
since inception.
Recent Developments
Caldolor®
In June 2009, the U.S. Food and Drug Administration (FDA) approved Caldolor, an
intravenous formulation of ibuprofen, for marketing in the United States through
a priority review. Caldolor is the first and only injectable product approved
for sale in the United States for the treatment of both pain and fever.
Following FDA approval, in preparation for the product launch, Cumberland
conducted comprehensive market research, prepared a full package of educational
materials, optimized territory design and launched the product website. We
expanded our hospital sales force to 77 representatives and managers to prepare
for the launch, and enlisted the services of our field sales force of 36
representatives and managers to promote the product. We also expanded our
internal professional affairs group to support the product.
In September 2009, we successfully implemented the U.S. launch of Caldolor, with
our 113 experienced sales professionals promoting the product across the
country. Caldolor is fully stocked at the wholesalers serving hospitals
nationwide, available in both 400mg and 800mg vials. We are working to secure
formulary approval nationally for Caldolor, and the product is already stocked
in a number of medical facilities.
We also filed the first of several expected new patent applications for Caldolor
in September. A part of an ongoing initiative to protect the value of our
intellectual property, this new application addresses our proprietary method of
dosing intravenous ibuprofen.
In October 2009, we announced that we entered into an exclusive agreement with
Phebra Pty Ltd., an Australian-based specialty pharmaceutical company, for the
commercialization of Caldolor in Australia and New Zealand. Phebra has
responsibility for obtaining any regulatory approval for the product, and for
handling all ongoing regulatory requirements, product marketing, distribution
and sales in the territories. We will maintain responsibility for product
formulation, development and manufacturing. Under the terms of the agreement,
Cumberland will receive upfront and milestone payments as well as a transfer
price, and we will receive royalties on any future sales of Caldolor in those
territories.
Initial Public Offering
In August 2009, we completed our initial public offering of 5,000,000 shares of
common stock at a price to the public of $17.00 per share, raising $85.0 million
in gross proceeds. After deducting underwriting discounts and offering costs,
the net proceeds to us were approximately $74.8 million. The proceeds from this
offering are primarily for potential acquisitions, the launch of Caldolor,
expansion of our hospital sales force, product development, debt repayment and
general corporate purposes. Our common stock began trading on the NASDAQ Global
Select Market on August 11, 2009, under the trading symbol "CPIX".
Following our initial public offering and the completion of the quarter ended
September 30, 2009, we notified Mellon Investor Services LLC that we will be
retaining Continental Stock Transfer & Trust Company as our transfer agent and
registrar, effective December 2009.
CRITICAL ACCOUNTING POLICIES AND SIGNIFICANT JUDGMENTS AND ESTIMATES
Please see a discussion of our critical accounting policies and significant
judgments and estimates in Management's Discussion and Analysis for the year
ended December 31, 2008 on pages 33 through 38 in the Prospectus filed pursuant
to Rule 424(b) under the Securities Act filed with the SEC on August 12, 2009.
There have been no changes to these policies or estimates as of September 30,
2009, except as noted below.
Accounting Estimates and Judgments
The preparation of consolidated financial statements in conformity with U.S.
generally accepted accounting principles requires management to make estimates,
judgments and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent liabilities at the date of the
financial statements and the reported amounts of revenues and expenses during
the period. We base our estimates on past experience and on other factors we
deem reasonable given the circumstances. Past results help form the basis of our
judgments about the carrying value of assets and liabilities that are not
determined from other sources. Actual results could differ from these estimates.
These estimates, judgments and assumptions are most critical with respect to our
accounting for revenue recognition, provision for income taxes, stock-based
compensation, research and development expenses and intangible assets.
Revenue Recognition
Our revenue is derived primarily from the product sales of Acetadote, Kristalose
and Caldolor. Revenue is recognized when persuasive evidence of an arrangement
exists, delivery has occurred, the fee is fixed and determinable and
collectability is probable. Delivery is considered to have occurred upon either
shipment of the product or arrival at its destination based on the shipping
terms of the transaction. When these conditions are satisfied, we recognize
gross product revenue, which is the price we charge generally to our wholesalers
for a particular product.
Our return policy is to accept returns from wholesalers for expired product
within six months of the designated expiration date on the product label and no
more than six months beyond that date. In addition to accepting returns for
expired product, we also accept returns for damaged products that are deemed to
be our fault. Prior to recognizing revenue when a right of return exists,
companies must be able to estimate the amount of future returns. Our estimates
of future returns are based on relevant, historical return data, estimated
inventory levels in the distribution channel, estimated remaining shelf life and
projected demand for our product. Although Caldolor is a new product, it
represents a new formulation of ibuprofen, a compound that is widely used in
today's marketplace.
Our net product revenue reflects the reduction of gross product revenue at the
time of initial sales recognition for estimated accounts receivable allowances
for chargebacks, discounts and damaged product, as well as provisions for sales
related accruals of rebates, product returns and administrative fees and
fee-for-services.
The following table reflects our sales-related accrual activity:
Nine months ended September 30,
Sales related accruals 2008 2009
Balance at beginning of period $ 738,362 $ 1,040,203
Current provision 1,139,834 2,436,064
Current provision for prior period sales (73,960 ) 75,589
Actual returns/credits (927,015 ) (1,916,834 )
Balance at end of period $ 877,221 $ 1,635,022
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RESULTS OF OPERATIONS
Three months ended September 30, 2009 compared to the three months ended
September 30, 2008
Net revenues. Net revenues for the three months ended September 30, 2009 totaled
approximately $13.6 million, representing an increase of approximately
$5.0 million, or 58%, over the same period in 2008. The increase was primarily
due to (1) increased net revenue of $1.4 million for Acetadote and (2) net
revenue associated with the launch of Caldolor of $3.2 million. Acetadote volume
increased 19% as we continued to gain market share in our target market. The
remainder of the increase in net revenue of Acetadote was due to an increase in
the selling price.
For the three months ended September 30, 2009, gross sales were reduced by
approximately $1.6 million, of which approximately $1.0 million related to
product returns and fee-for-service. The remaining deductions included rebates,
cash discounts and similar items. For the three months ended September 30, 2008,
gross sales were reduced by approximately $0.8 million, consisting of deductions
for product returns, cash discounts, fee-for-services and rebates.
Cost of products sold. Cost of products sold for the three months ended
September 30, 2009 totaled approximately $1.8 million, representing an increase
of approximately $1.0 million, or 139%, over the same period in 2008. As a
percentage of net revenues, cost of products sold increased from 8.5% of net
revenues for the three months ended September 30, 2008 to 13.0% of net revenues
for the three months ended September 30, 2009. The increase in cost of products
sold as a percentage of net revenues was primarily due to a change in the sales
mix between the periods.
Selling and marketing. Selling and marketing expense for the three months ended
September 30, 2009 totaled approximately $6.1 million, representing an increase
of approximately $2.5 million, or 68%, over the same period in 2008. The
increase was primarily due to additional expenses associated with the launch of
Caldolor, including the expansion of our sales force in the third quarter of
2009.
General and administrative. General and administrative expense for the three
months ended September 30, 2009 totaled approximately $2.5 million, representing
an increase of approximately $1.4 million, or 117%, over the same period in
2008. The increase is primarily due to (1) increased payroll tax expense of
approximately $1.0 million associated with the exercise of nonqualified options
in the third quarter of 2009 and (2) increased personnel and related expenses of
$0.2 million.
Income tax expense. As a percentage of net income before income taxes, the tax
rate decreased from 43.9% for the three months ended September 30, 2008 to 40.0%
for the same period in 2009. The decrease in the tax rate was primarily due to
the inclusion in 2009 of research and development tax credits that were not in
effect during the three months ended September 30, 2008. The research and
development tax credits were enacted by Congress in the fourth quarter of 2008.
In the third quarter of 2009, nonqualified stock options were exercised which
resulted in a tax benefit of approximately $26.7 million to us. In recognizing
tax benefits, we follow the tax-law ordering of deductions, which preclude the
recognition of tax benefits until those benefits are used to offset income taxes
payable. We do not believe the tax benefit generated in the third quarter of
2009 will be used in 2009. As a result, we have not recognized the tax benefit
from the exercise of those options. The tax benefit, with a corresponding
increase to common stock, will be recognized in future periods when they are
used to offset the income tax liability generated in those periods.
Nine months ended September 30, 2009 compared to the nine months ended
September 30, 2008
Net revenues. Net revenues for the nine months ended September 30, 2009 totaled
approximately $32.8 million, representing an increase of approximately
$7.6 million, or 30%, over the same period in 2008. The increase in net revenues
was primarily due to (1) approximately $3.2 million associated with the launch
of Caldolor in September 2009 and (2) an increase in net revenues of Acetadote.
Acetadote volume increased 17% as we continued to gain market share in our
target market. The remainder of the increase in net revenues of Acetadote was
due to an increase in the selling price.
For the nine months ended September 30, 2009, gross sales were reduced by
approximately $3.8 million, of which approximately $2.4 million related to
product returns and fee-for-service. The remaining deductions included cash
discounts, rebates and similar items. For the nine months ended September 30,
2008, gross sales were reduced by approximately $1.9 million, consisting of
deductions for product returns, cash discounts, fee-for-services and rebates.
Cost of products sold. Cost of products sold for the nine months ended
September 30, 2009 totaled approximately $3.3 million, representing an increase
of approximately $1.0 million, or 47%, over the same period in 2008. As a
percentage of net revenues, cost of products sold increased from 8.8% for the
nine months ended September 30, 2008 to 10.0% for the nine months ended
September 30, 2009. The increase in cost of products sold as a percentage of net
revenues was primarily due to a change in the sales mix between the periods.
Selling and marketing. Selling and marketing expense for the nine months ended
September 30, 2009 totaled approximately $14.6 million, representing an increase
of approximately $4.0 million, or 38%, over the same period in 2008. The
increase was primarily due to (1) increased marketing, advertising and market
research for Caldolor and Acetadote, (2) increased payroll and related costs due
to the expansion of our sales force, (3) increased royalty expense as a result
of our increase in sales and (4) increased freight and distribution costs.
Research and development. Research and development expense for the nine months
ended September 30, 2009 totaled approximately $4.0 million, representing an
increase of approximately $1.3 million, or 47%, over the same period in 2008.
The increase was primarily due to the recognition of approximately $2.0 million
of milestone obligations due upon FDA approval of Caldolor in June 2009. The
milestone payments include approximately $1.0 million of cash payments to a
third-party who assisted in early development efforts. We have paid
approximately $0.8 million of the liability, with the remaining due in equal
monthly installments through July 2010. In addition to the cash payments, the
third party immediately vested in 60,000 stock options with a fair value of
approximately $0.8 million at the time of approval, calculated using the
Black-Scholes methodology. A separate third-party research institution
immediately vested in 10,000 shares of common stock valued at $150,000 upon FDA
approval.
The increase in research and development expense resulting from the milestone
obligations was offset by a decrease in supplies expense in 2009 as compared to
2008. In 2008, we incurred setup and validation costs associated with entering
into a new supplier agreement for two of our products that did not reoccur in
2009.
General and administrative. General and administrative expense for the nine
months ended September 30, 2009 totaled approximately $5.2 million, representing
an increase of approximately $1.9 million, or 60%, over the same period in 2008.
The increase is primarily due to (1) increased payroll-related taxes associated
with the exercise of nonqualified options in 2009, (2) increased stock
compensation expense due to the timing of when stock options were issued in 2009
as compared to 2008 and (3) increased personnel and related expenses primarily
due to personnel additions.
Income tax expense. Income tax expense for the nine months ended September 30,
2009 totaled approximately $1.9 million, representing a decrease of
approximately $0.2 million, or 10%, over the same period in 2008. As a
percentage of net income before income taxes, income tax expense increased from
36.8% for the nine months ended September 30, 2008 to 40.9% for the same period
in 2009. The increase in the tax rate was primarily due to (1) the recognition
in the first quarter of 2008 of approximately $0.4 million of previously
unrecognized tax benefits and (2) an increase in incentive stock options expense
in 2009 for which we do not receive a tax benefit.
In the third quarter of 2009, nonqualified stock options were exercised which
resulted in a tax benefit of approximately $26.7 million to us. In recognizing
tax benefits, we follow the tax-law ordering of deductions, which preclude the
recognition of tax benefits until those benefits are used to offset income taxes
payable. We do not believe the tax benefit generated in the third quarter of
2009 will be used to offset the tax liability created from the results of
operations in 2009. As a result, we have not recognized the tax benefit from the
exercise of those options. The tax benefit, with a corresponding increase to
common stock, will be recognized in future periods when they are used to offset
the income tax liability generated in those periods.
LIQUIDITY AND CAPITAL RESOURCES
Working Capital
Our primary sources of liquidity are cash flows provided by our operations, our
borrowings and the cash proceeds from our initial public offering of common
stock. We believe that our internally generated cash flows and amounts available
under our credit facilities will be adequate to service existing debt, finance
internal growth and fund capital expenditures. As of December 31, 2008 and
September 30, 2009, cash and cash equivalents was $11.8 million and
$79.5 million, respectively, working capital (current assets minus current
liabilities) was $10.1 million and $78.0 million, respectively, and our current
ratio (current assets to current liabilities) was 2.3x and 6.8x, respectively.
As of September 30, 2009, we had an additional $2.2 million available to us on
our line of credit.
On August 10, 2009, we completed our initial public offering of 5,000,000 shares
of common stock at $17.00 per share, raising gross proceeds of $85.0 million.
After deducting underwriting discounts of approximately $6.0 million and
offering costs of approximately $4.2 million, the net proceeds were
approximately $74.8 million.
In July 2009, we amended our debt agreement to provide for $18.0 million in term
debt and a $4.0 million revolving credit facility. We used $4.2 million of the
proceeds from our initial public offering to repay the outstanding balance from
our previous term debt agreement. Further, we used the proceeds from the new
term debt to pay, in part, the minimum statutory tax withholding requirements of
approximately $24.6 million due from the exercise of options to purchase shares
of our common stock at the pricing of our initial public offering on August 10,
2009. The remaining balance due of approximately $6.6 million related to the
minimum statutory tax withholding requirements was funded by our existing cash
balances. The exercise of stock options generated a tax benefit of approximately
$26.7 million to us. We will recognize this benefit as a reduction in income
taxes payable when those benefits are realized.
The following table summarizes our net changes in cash and cash equivalents for the nine months ended September 30, 2008 and 2009:
Nine Months Ended September 30,
2008 2009
(in thousands)
Net cash provided by (used in):
Operating activities $ 4,239 $ 1,924
Investing activities (124 ) (271 )
Financing activities (3,767 ) 66,059
Net increase in cash and cash equivalents (1) $ 349 $ 67,712
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(1) The sum of the individual amounts may not agree due to rounding.
Cash provided by operating activities for the nine months ended September 30,
2009 of approximately $1.9 million was primarily due to net income of
approximately $2.8 million adjusted for (1) noncash expenses of approximately
$2.2 million and (2) a decrease in working capital of $0.2 million. Also
impacting cash provided by operating activities is the requirement that the tax
benefit recognized from the exercise of nonqualified options be reflected as a
cash outflow in operations and a cash inflow in financing activities.
Cash used by investing activities for the nine months ended September 30, 2009
of approximately $0.3 million was primarily due to the purchase of property and
equipment.
Cash provided by financing activities for the nine months ended September 30,
2009 of approximately $66.1 million was primarily due to (1) proceeds from our
initial public offering of $85.0 million, net of offering costs paid of
approximately $7.4 million, (2) additional borrowings of $18.0 million of term
debt, (3) principal payments of $5.0 million related to the payoff of our old
term debt balance, (4) the excess tax benefit derived from the exercise of stock
options that is required to be reflected as a cash inflow from financing
activities and (5) payments made in connection with the repurchase of common
shares that were tendered to settle the minimum statutory withholding
requirements associated with the exercise of stock options in 2009.
OFF-BALANCE SHEET ARRANGEMENTS
During the nine months ended September 30, 2009, we did not engage in any
off-balance sheet arrangements.
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