Market Snapshot
  • U.S.
  • Europe
  • Asia
Ticker Volume Price Price Delta
DJIA 16,408.54 -16.31 -0.10%
S&P 500 1,864.85 2.54 0.14%
NASDAQ 4,095.52 9.29 0.23%
Ticker Volume Price Price Delta
STOXX 50 3,155.81 16.55 0.53%
FTSE 100 6,625.25 41.08 0.62%
DAX 9,409.71 91.89 0.99%
Ticker Volume Price Price Delta
NIKKEI 14,516.27 98.74 0.68%
TOPIX 1,173.37 6.78 0.58%
HANG SENG 22,760.24 64.23 0.28%

Cumberland Pharmaceuticals Reports Second Quarter Financial Results



     Cumberland Pharmaceuticals Reports Second Quarter Financial Results

- Caldolor pediatric fever study completed with positive top-line results.

- New international agreements signed including South America and Pacific Rim.

PR Newswire

NASHVILLE, Tenn., Aug. 6, 2013

NASHVILLE, Tenn., Aug. 6, 2013 /PRNewswire/ -- Cumberland Pharmaceuticals Inc.
(NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute
care and gastroenterology, today announced second quarter 2013 financial
results.

Net Revenue:  For the three months ended June 30, 2013, net revenue was $7.1
million compared to $12.4 million for the prior year period.

Net revenue was $4.1 million for Acetadote, $2.0 million for Kristalose and
$0.6 million for Caldolor. Other revenue was $0.3 million and includes upfront
payments recognized as a result of new international agreements.

For the six months ended June 30, 2013, net revenue was $17.3 million compared
with $22.6 million for the six months ended June 30, 2012.

Operating Expenses:  Total operating expenses for the three months ended
June 30, 2013, were $8.2 million compared to $10.4 million during the prior
year period. 

For the six months ended June 30, 2013, operating expenses were $17.2 million
compared to $20.0 million for the prior year period.

Net Income (Loss):  Net income (loss) attributable to common shareholders for
the three months ended June 30, 2013, was $(0.6) million, or $(0.03) per
diluted share.

For the six months ended June 30, 2013, net income attributable to common
shareholders was $0.2 million, or $0.01 per diluted share.

Cash Flow: Operating cash flows for the six months ended June 30, 2013, were
$1.8 million, compared to $3.2 million, for the prior year period. 

Balance Sheet:  As of June 30, 2013, Cumberland had $69.2 million in cash and
marketable securities, with approximately $49.7 million in cash and
equivalents and $19.5 million in marketable securities.  Total assets at
June 30, 2013, were $95.5 million.

"We made considerable progress this quarter by completing our pediatric
program for Caldolor, obtaining FDA approval for new Acetadote labeling and
further expanding our network of international partners," said A.J. Kazimi,
Chief Executive Officer of Cumberland Pharmaceuticals. "We are fortunate to
have a strong balance sheet through this transition period as we manage
Acetadote's life cycle and work to add new products to our portfolio."

Product Highlights

Caldolor^®

Caldolor Pediatric Fever Study

Today, Cumberland announced top-line results from a clinical pediatric fever
study evaluating the safety and efficacy of Caldolor (ibuprofen) Injection
compared to acetaminophen in treating fever (greater than or equal to 101.0
degrees F) in hospitalized patients ranging from birth to 16 years old. One
hundred and three patients were enrolled in this multi-center, randomized,
open-label active comparator study. The pediatric patients received either 10
mg/kg intravenous ibuprofen (not to exceed 400 mg per dose) or 10 mg/kg
acetaminophen (not to exceed 650 mg per dose).

The primary endpoint of the study was to assess the area under the change in
temperature versus time curve from baseline to 2 hours after the start of the
initial dose of study drug. In the two hours following dosing, pediatric
patients receiving intravenous ibuprofen experienced a greater temperature
reduction compared to patients receiving acetaminophen, p= 0.012; therefore
meeting the primary endpoint of the study. 

After a single dose, significantly more patients receiving intravenous
ibuprofen (93%) were considered to no longer be febrile (temperature less than
100.4 degrees F) compared to patients receiving acetaminophen (78%), p=0.036.

Patients receiving intravenous ibuprofen experienced a greater temperature
reduction compared to patients receiving acetaminophen upon all temperature
assessments during the four hours after dosing with reductions reaching
statistical significance by ninety minutes post-dose.

No safety concerns were identified in the study, as the incidence of adverse
events was similar across the treatment groups.

Acetadote^®

Acetadote Updated Labeling

In June 2013, Cumberland announced that the U.S. Food and Drug Administration
("FDA") approved updated labeling for Acetadote (acetylcysteine) Injection.
The new labeling revises the product's indication and offers new dosing
guidance for specific patient populations.  The new indication states,
"Acetadote is an antidote for acetaminophen overdose indicated to prevent or
lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of
acetaminophen." The product's previous indication included the qualifying
phrase, "administered intravenously within 8 to 10 hours," which was
originally intended to impress the urgency for early treatment. This phrase
has been removed due to potential confusion concerning efficacy when
administration within that time period is not possible.

In addition, specific dosing guidance is now included for patients weighing
over 100 kg. New language has also been added to alert health care providers
that in certain clinical situations, therapy should be extended for some
patients.

Acetadote does not contain Ethylene diamine tetracetic acid (EDTA) or any
other stabilization or chelating agents and is free of preservatives.  The
product's formulation was developed as part of our Phase IV commitment in
response to a request by the FDA to evaluate the reduction of EDTA. The new
formulation's 30 month shelf life is longer than the shelf life of the
previous formulation.

International Licensing Agreements

During the second quarter of 2013, Cumberland entered into two new agreements
for the registration and commercialization of Caldolor outside the United
States.  The first agreement is with the Spanish-based company, Laboratorios
Grifols, S.A, for a territory that includes Spain, Portugal, Argentina, Chile,
Brazil, Ecuador, Peru, and Uruguay. The second agreement is with PT. SOHO
Industri Pharmasi an Indonesian-based company and includes a territory of
Singapore, Thailand, Vietnam, Cambodia, Laos, Brunei and the Philippines.

Also during the second quarter, Cumberland amended the agreement with Harbin
Gloria Pharmaceuticals for the registration and commercialization of Caldolor
and Acetadote in China by extending the territory to include Hong Kong and
Macau.

The agreements entered into during 2013 provide that each of the partners are
responsible for seeking regulatory approvals for the products, and following
approvals, will handle ongoing distribution and sales in the respective
international territories. Cumberland maintains responsibility for the
intellectual property, product formulations, development and manufacturing,
and will provide finished product for sale. Under the licensing agreements,
Cumberland is entitled to receive upfront and milestone payments upon the
achievement of defined regulatory approvals and sales milestones. 

Conference Call and Webcast

A conference call and live Internet webcast will be held on Tuesday, August 6,
2013 at 4:30 p.m. Eastern Time to discuss the Company's second quarter 2013
financial results. To participate in the call, please dial 877-303-1298 (for
U.S. callers) or 253-237-1032 (for international callers). A rebroadcast of
the teleconference will be available for one week and can be accessed by
dialing 855-859-2056 (for U.S. callers) or 404-537-3406 (for international
callers). The Conference ID for the rebroadcast is 24879662. The live webcast
and rebroadcast can be accessed via Cumberland's website at
http://investor.shareholder.com/cpix/events.cfm.

About Cumberland Pharmaceuticals

Cumberland Pharmaceuticals Inc. is a specialty pharmaceutical company focused
on the acquisition, development and commercialization of branded prescription
products. The Company's primary target markets include hospital acute care and
gastroenterology. Cumberland's marketed products include Acetadote^®
(acetylcysteine) Injection for the treatment of acetaminophen poisoning,
Caldolor^® (ibuprofen) Injection, the first injectable treatment for pain and
fever approved in the United States, and Kristalose^® (lactulose) for Oral
Solution, a prescription laxative. Cumberland is dedicated to providing
innovative products that improve quality of care for patients. For more
information, please visit the Company's website at www.cumberlandpharma.com.

About Acetadote

Acetadote is an antidote for acetaminophen overdose indicated to prevent or
lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of
acetaminophen. Used in the emergency department, Acetadote is approved in the
United States to treat overdose of acetaminophen, a common ingredient in many
over-the-counter medications. Acetadote is contraindicated in patients with
hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any
components of the preparation. Serious anaphylactoid reactions, including
death in a patient with asthma, have been reported in patients administered
acetylcysteine intravenously. Acetadote should be used with caution in
patients with asthma or where there is a history of bronchospasm. The total
volume administered should be adjusted for patients weighing less than 40 kg
and for those requiring fluid restriction. To avoid fluid overload, the volume
of diluent should be reduced as needed. If volume is not adjusted, fluid
overload can occur, potentially resulting in hyponatremia, seizure and death. 
For full prescribing information, visit www.acetadote.com.

About Caldolor

Caldolor is indicated for the management of mild to moderate pain and
management of moderate to severe pain as an adjunct to opioid analgesics, as
well as the reduction of fever in adults. It was the first FDA-approved
intravenous therapy for fever. Caldolor is contraindicated in patients with
known hypersensitivity to ibuprofen or other NSAIDs, patients with asthma,
urticarial, or allergic type reactions after taking aspirin or other NSAIDs.
Caldolor is contraindicated for use during the peri-operative period in the
setting of coronary artery bypass graft (CABG) surgery. Caldolor should be
used with caution in patients with prior history of ulcer disease or GI
bleeding, in patients with fluid retention or heart failure, in the elderly,
those with renal impairment, heart failure, liver impairment, and those taking
diuretics or ACE inhibitors. Blood pressure should be monitored during
treatment with Caldolor.  For full prescribing information, including boxed
warning, visit www.caldolor.com.

About Kristalose

Kristalose is indicated for the treatment of acute and chronic constipation.
It is a unique, proprietary, crystalline form of lactulose, with no
restrictions on length of therapy or patient age. Initial dosing may produce
flatulence and intestinal cramps, which are usually transient.  Excessive
dosage can lead to diarrhea with potential complications such as loss of
fluids, hypokalemia and hypernatremia. Nausea and vomiting have been reported.
Use with caution in diabetics. Kristalose is contraindicated in patients who
require a low-galactose diet. Elderly, debilitated patients who receive
lactulose for more than six months should have serum electrolytes (potassium,
chloride, carbon dioxide) measured periodically. For full prescribing
information, visit www.kristalose.com.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to
certain risks and reflect Cumberland's current views on future events based on
what it believes are reasonable assumptions. No assurance can be given that
these events will occur. As with any business, all phases of Cumberland's
operations are subject to factors outside of its control, and any one or
combination of these factors could materially affect Cumberland's results of
operations. These factors include market conditions, competition, an inability
of manufacturers to produce Cumberland's products on a timely basis or failure
of manufacturers to comply with regulations applicable to pharmaceutical
manufacturers, maintaining an effective sales and marketing infrastructure and
other factors discussed in the Company's most recent Form 10-K and subsequent
10-Q's as filed with the SEC. There can be no assurance that results
anticipated by the Company will be realized or that they will have the
expected effects. Readers are cautioned not to place undue reliance on
forward-looking statements, which speak only as of the date hereof. The
Company does not undertake any obligation to publicly revise these statements
to reflect events after the date hereof.

 

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited)
                                                  June 30,       December 31,
                                                  2013           2012
ASSETS
Current assets:
Cash and cash equivalents                         $ 49,664,762   $ 54,349,381
Marketable securities                             19,513,639     16,686,136
Accounts receivable, net of allowances            3,970,942      6,017,201
Inventories                                       6,094,294      6,218,355
Other current assets                              3,197,594      3,961,169
   Total current assets                           82,441,231     87,232,242
Property and equipment, net                       1,055,677      1,188,914
Intangible assets, net                            10,649,164     9,476,798
Other assets                                      1,319,538      695,777
     Total assets                                 $ 95,465,610   $ 98,593,731
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable                                  $ 3,094,071    $ 2,790,554
Other current liabilities                         3,000,549      5,264,806
   Total current liabilities                      6,094,620      8,055,360
Revolving line of credit                          5,859,951      4,359,951
Other long-term liabilities                       637,671        611,933
   Total liabilities                              12,592,242     13,027,244
Commitments and contingencies
Equity:
Shareholders' equity:
     Common stock—no par value; 100,000,000
shares authorized; 
                                 18,306,364 and   64,311,576     67,197,167
18,937,107 shares issued and outstanding as of 
                                 June 30, 2013
and December 31, 2012, respectively
     Retained earnings                            18,714,845     18,499,154
        Total shareholders' equity                83,026,421     85,696,321
Noncontrolling interests                          (153,053)      (129,834)
  Total equity                                    82,873,368     85,566,487
     Total liabilities and equity                 $ 95,465,610   $ 98,593,731

 

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations and Comprehensive (Loss) Income
(Unaudited)
                      Three months ended June 30,  Six months ended June 30,
                      2013          2012           2013           2012
Net revenues          $ 7,081,088   $ 12,366,940   $ 17,339,220   $ 22,623,152
Costs and expenses:
Cost of products sold 1,154,833     1,103,005      2,263,468      1,951,555
Selling and marketing 3,542,049     5,491,964      7,215,988      10,472,517
Research and          1,386,904     1,553,343      2,835,622      2,957,365
development
General and           1,855,201     2,147,518      4,430,940      4,412,543
administrative
Amortization          282,645       131,179        407,695        243,226
Total costs and       8,221,632     10,427,009     17,153,713     20,037,206
expenses
Operating (loss)      (1,140,544)   1,939,931      185,507        2,585,946
income
Interest income       48,982        76,074         141,359        148,355
Interest expense      (20,700)      (16,720)       (38,435)       (39,147)
(Loss) income before  (1,112,262)   1,999,285      288,431        2,695,154
income taxes
Income tax benefit    463,408       (263,031)      (95,959)       (545,059)
(expense)
Net (loss) income     (648,854)     1,736,254      192,472        2,150,095
Net loss at
subsidiary
attributable to       9,836         8,036          23,219         17,403
noncontrolling
interests
Net (loss) income
attributable to       $ (639,018)   $ 1,744,290    $ 215,691      $ 2,167,498
common 
         shareholders
Earnings (loss) per
share attributable to
common
shareholders
- basic               $ (0.03)      $ 0.09         $ 0.01         $ 0.11
- diluted             $ (0.03)      $ 0.09         $ 0.01         $ 0.11
Weighted-average
shares outstanding
- basic               18,405,522    19,771,167     18,580,891     19,889,583
- diluted             18,405,522    19,996,805     18,756,691     20,117,246
Comprehensive (loss)  $ (648,854)   $ 1,736,254    $ 192,472      $ 2,150,095
income

 

 

CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited)
                                                  Six months ended June 30,
                                                  2013           2012
Cash flows from operating activities:
Net income                                        $ 192,472      $ 2,150,095
Adjustments to reconcile net income to net cash
provided by operating 
         activities:
    Depreciation and amortization expense         610,052        441,199
    Deferred tax expense                          65,413         —
    Share-based compensation                      305,199        390,788
    Excess tax benefit derived from exercise of   (15,288)       (854,988)
stock options
    Noncash interest expense                      12,038         12,038
    Noncash investment (gains) losses             62,323         (34,604)
    Net changes in assets and liabilities
affecting operating activities:
        Accounts receivable                       2,046,259      2,091,278
        Inventory                                 124,061        (1,541,912)
        Other current assets and other assets     59,877         (173,889)
        Accounts payable and other current        (1,707,560)    1,362,385
liabilities
        Other long-term liabilities               37,479         (596,911)
    Net cash provided by operating activities     1,792,325      3,245,479
Cash flows from investing activities:
    Additions to property and equipment           (69,119)       (178,886)
    Purchases of marketable securities            (4,371,508)    (18,356,482)
    Proceeds from sale of marketable securities   1,481,682      145,646
    Additions to intangible assets                (1,829,693)    (519,719)
        Net cash used in investment activities    (4,788,638)    (18,909,441)
Cash flows from financing activities:
    Net borrowings (repayments) on line of credit 1,500,000      (500,000)
    Exercise of stock options                     (41,292)       545,601
    Excess tax benefit derived from exercise of   15,288         854,988
stock options
    Repurchase of common shares                   (3,162,302)    (3,562,381)
        Net cash used in financing activities     (1,688,306)    (2,661,792)
        Net decrease in cash and cash equivalents (4,684,619)    (18,325,754)
Cash and cash equivalents at beginning of period  54,349,381     70,599,146
Cash and cash equivalents at end of period        $ 49,664,762   $ 52,273,392
Supplemental disclosure of cash flow information:
Non-cash investing and financing activities:
    Net change in unpaid additions to             $ 249,633      $ 73,457
intangibles, property and equipment

 

 

SOURCE Cumberland Pharmaceuticals Inc.

Website: http://www.cumberlandpharma.com
Contact: Investor Contact: Elizabeth Davis, Corporate Relations, (615)
255-0068; Media Contact: Rebecca Kirkham, Lovell Communications, (615)
297-7766
Sponsored Links
Advertisement
Advertisements
Sponsored Links
Advertisement