Cumberland Pharmaceuticals Reports First Quarter Financial Results

      Cumberland Pharmaceuticals Reports First Quarter Financial Results

- Diluted earnings per share increased 150% to $0.05

PR Newswire

NASHVILLE, Tenn., May 2, 2013

NASHVILLE, Tenn., May 2, 2013 /PRNewswire/ --Cumberland Pharmaceuticals Inc.
(NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute
care and gastroenterology, today announced first quarter 2013 financial
results.

Net Revenue: For the three months ended March31, 2013, net revenue was $10.3
million, in line with net revenues from the first quarter of 2012.

Operating Expenses: Total operating expenses for the three months ended March
31, 2013, were $8.9 million compared to $9.6 million during the prior year
period. This decrease was driven primarily by the realignment of the sales
force in late 2012.

Net Income: Net income attributable to common shareholders for the three
months ended March31, 2013, was $0.9 million, or $0.05 per diluted share,
compared to $0.4 million, or $0.02 per diluted share, for the same period in
2012.

Cash Flow: Operating cash flows for the three months ended March31, 2013,
were $1.7 million, compared to $2.6 million, for the prior year period.

Balance Sheet: As of March31, 2013, Cumberland had $70.2 million in cash and
marketable securities, with approximately $51.2 million in cash and
equivalents and $19.0 million in marketable securities. Total assets at
March31, 2013, were $98.3 million.

"Our progress during the first quarter included top line results from three
new Caldolor studies and new international partnerships for India and
Indonesia," said A.J. Kazimi, Chief Executive Officer of Cumberland
Pharmaceuticals. "We were also pleased with the first quarter financial
results maintaining revenues from the prior year quarter, while significantly
increasing our net income through the efficient management of our expenses."

Product Highlights

Acetadote^®

In January 2013, Cumberland initiated shipments of the Company's Authorized
Generic version of Acetadote distributed by Perrigo Company. The Authorized
Generic resulted from a License and Supply Agreement with Perrigo and a
related Settlement Agreement with Paddock Laboratories, LLC and Perrigo
Company signed in November 2012.

On March 19, 2013, the United States Patent and Trademark Office issued U.S.
Patent number 8,399,445. The claims of this second Acetadote patent encompass
the use of the 200 mg/ml Acetadote formulation to treat patients with
acetaminophen overdose. On April 8, 2013, the new Acetadote patent was listed
in the FDA "Orange Book" and it is scheduled to expire in August 2025.

Caldolor^®

In February 2013, Cumberland announced the top-line results from two registry
studies evaluating the safety and efficacy of Caldolor (ibuprofen) Injection
administered over a shortened infusion time in treating pain and fever in
adult patients. The studies involved 450 patients receiving Caldolor at 34
leading medical centers throughout the United States.

The first of two registry studies was a phase IV multi-center, open-label
surveillance clinical study to assess the safety and efficacy of ibuprofen
administered intravenously over five to ten minutes to adult patients in the
hospital setting with temperature fever (>101 degrees F) and/or pain (visual
analog scale (VAS) assessment >3). Eligible patients were enrolled to receive
one of two dose strengths (400 mg for treatment of fever, 800 mg for treatment
of pain) of intravenous ibuprofen for up to a 24- hour dosing period. One
hundred fifty patients from 13 clinical sites were enrolled in this study.
Intravenous ibuprofen reduced fever and pain and the shortened infusion time
was well tolerated.

The second of two registry studies was a phase IV multi-center, open-label
surveillance clinical study to assess the safety of ibuprofen administered
intravenously over five to ten minutes to adult hospitalized patients
undergoing surgical procedures. Eligible patients were enrolled to receive 800
mg intravenous ibuprofen administered at induction of anesthesia and could
continue Caldolor therapy for up to 24 hours. Three hundred patients from
21clinical sites were enrolled in this study. The shortened infusion time was
well tolerated.

In February 2013, Cumberland also announced favorable top line results from a
pilot clinical study evaluating the safety and analgesic efficacy of Caldolor
(ibuprofen) Injection compared to ketorolac injection in treating pain
following knee arthroscopy procedures in adult patients. The study was
conducted at the Ohio State University Medical Center. The study enrolled
fifty-one patients and the results indicate, compared to patients receiving
ketorolac, patients receiving intravenous ibuprofen experienced less
postoperative pain prior to discharge. Patients receiving Caldolor also needed
fewer narcotics and were less likely to require narcotics prior to discharge.
This data supports the benefits of using Caldolor in a pre-emptive model of
multimodal analgesia.

International Agreements

In January 2013, Cumberland entered into agreements with India's Sandor
Medicaids Pvt. Ltd. and Indonesia's PT. SOHO Industri Pharmasi (a SOHO Group
company) for the commercialization of Caldolor in those countries. Cumberland
also entered into an agreement with GerminMED W.L.L. for the commercialization
of Acetadote, Caldolor and Kristalose in the Arabian Peninsula.

Conference Call and Webcast

A conference call and live Internet webcast will be held on Thursday, May 2,
2013 at 4:30 p.m. Eastern Time to discuss the Company's first 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 46598348. 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, administered intravenously within 8 to 10 hours after ingestion of
a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent
or lessen hepatic injury. 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)
                                             March31, 2013  December 31, 2012
ASSETS
Current assets:
Cash and cash equivalents                    $  51,209,544   $   54,349,381
Marketable securities                        18,958,810      16,686,136
Accounts receivable, net of allowances       5,967,631       6,017,201
Inventories                                  5,992,031       6,218,355
Other current assets                         3,892,239       3,961,169
Total current assets                         86,020,255      87,232,242
Property and equipment, net                  1,153,426       1,188,914
Intangible assets, net                       10,403,974      9,476,798
Other assets                                 700,095         695,777
Total assets                                 $  98,277,750   $   98,593,731
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable                             $  3,427,256    $   2,790,554
Other current liabilities                    4,808,531       5,264,806
Total current liabilities                    8,235,787       8,055,360
Revolving line of credit                     4,359,951       4,359,951
Other long-term liabilities                  652,371         611,933
Total liabilities                            13,248,109      13,027,244
Commitments and contingencies
Equity:
Shareholders' equity:
Common stock—no par value; 100,000,000

shares authorized; 18,549,749 and 18,937,107
                                             65,818,995      67,197,167
shares issued and outstanding as of
March31,

2013 and December31, 2012, respectively
Retained earnings                            19,353,863      18,499,154
Total shareholders' equity                   85,172,858      85,696,321
Noncontrolling interests                     (143,217)       (129,834)
Total equity                                 85,029,641      85,566,487
Total liabilities and equity                 $  98,277,750   $   98,593,731



CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Income and Comprehensive Income

(Unaudited)
                                                  Three months ended March 31,
                                                  2013           2012
Net revenues                                      $ 10,258,132   $ 10,256,212
Costs and expenses:
Cost of products sold                             1,108,635      848,550
Selling and marketing                             3,673,939      4,980,553
Research and development                          1,448,718      1,404,022
General and administrative                        2,575,739      2,265,025
Amortization                                      125,050        112,047
Total costs and expenses                          8,932,081      9,610,197
Operating income                                  1,326,051      646,015
Interest income                                   92,377         72,281
Interest expense                                  (17,735)       (22,427)
Income before income taxes                        1,400,693      695,869
Income tax expense                                (559,367)      (282,028)
Net income                                        841,326        413,841
Net loss at subsidiary attributable to            13,383         9,367
noncontrolling interests
Net income attributable to common shareholders    $ 854,709      $ 423,208
Earnings per share attributable to common
shareholders
- basic                                           $ 0.05         $ 0.02
- diluted                                         $ 0.05         $ 0.02
Weighted-average shares outstanding
- basic                                           18,758,383     20,007,998
- diluted                                         18,925,165     20,234,438
Comprehensive income                              $ 841,326      $ 413,841



CUMBERLAND PHARMACEUTICALS INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(Unaudited)
                                                  Three months ended March 31,
                                                  2013           2012
Cash flows from operating activities:
Net income                                        $ 841,326      $ 413,841
Adjustments to reconcile net income to net cash
provided by operating

activities:
Depreciation and amortization expense             290,508        217,263
Deferred tax expense                              65,413         —
Share-based compensation                          128,625        214,381
Excess tax benefit derived from exercise of stock (478,698)      (191,081)
options
Noncash interest expense                          6,019          6,019
Noncash investment gains (losses)                 10,571         (8,800)
Net changes in assets and liabilities affecting
operating activities:
Accounts receivable                               49,570         2,619,523
Inventory                                         226,324        (230,784)
Other current assets and other assets             (8,298)        (324,954)
Accounts payable and other current liabilities    492,983        (282,862)
Other long-term liabilities                       46,308         178,120
Net cash provided by operating activities         1,670,651      2,610,666
Cash flows from investing activities:
Additions to property and equipment               (60,911)       (32,800)
Purchases of marketable securities                (2,970,000)    (15,992,822)
Proceeds from sale of marketable securities       686,755        —
Additions to intangible assets                    (961,013)      (180,787)
Net cash used in investment activities            (3,305,169)    (16,206,409)
Cash flows from financing activities:
Net borrowings on line of credit                  —              250,000
Proceeds from exercise of stock options           (41,292)       545,601
Excess tax benefit derived from exercise of stock 478,698        191,081
options
Repurchase of common shares                       (1,942,725)    (2,346,524)
Net cash used in financing activities             (1,505,319)    (1,359,842)
Net decrease in cash and cash equivalents         (3,139,837)    (14,955,585)
Cash and cash equivalents at beginning of period  54,349,381     70,599,146
Cash and cash equivalents at end of period        $ 51,209,544   $ 55,643,561
Supplemental disclosure of cash flow information:
Non-cash investing and financing activities:
Net change in unpaid additions to intangibles,    $ 160,272      $ 82,696
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
 
Press spacebar to pause and continue. Press esc to stop.