NASHVILLE, Tenn., Nov. 13, 2018 /PRNewswire/ -- Cumberland
Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical
company focused on hospital acute care, gastroenterology, and
oncology supportive care today announced third quarter 2018
financial results and Company update. Cumberland has a portfolio of eight U.S. Food
and Drug Administration (FDA) approved brands. Net revenues for the
quarter were $8.5 million. At the end
of the third quarter, Cumberland
had $87 million in total assets,
including approximately $48 million
in cash and marketable securities.
RECENT HIGHLIGHTS:
- Added to our commercial product line with the addition of
Vibativ®, a patented, FDA approved, injectable
product designed for the treatment of certain serious and difficult
to treat infections
- Submitted an amendment to our FDA application for approval of
our Next Generation Caldolor® product, containing
additional requested quality and nonclinical data
- Filed a New Drug Application (NDA) to the FDA for the approval
of our RediTrexTM methotrexate product
line, designed for treating patients with arthritis and
psoriasis
- Added to the growing library of literature supporting
Caldolor® and Ethyol® with a
series of favorable clinical study publications
- Completed patient enrollment in the initial Phase II clinical
study for Portaban® - the Company's product
candidate for the treatment of Portal Hypertension
- Received a $2 million grant
awarded to Cumberland Emerging Technologies (CET) in support
of a joint research program that addresses the significant need of
improving clinical outcomes for certain lung cancer patients.
"Our team has been very busy during the third quarter, working
to maximize the potential of our existing brands while continuing
to build a portfolio of differentiated products," said A.J. Kazimi,
Chief Executive Officer of Cumberland Pharmaceuticals. "We continue
to build a specialty pharmaceutical company that delivers sustained
growth, profitable operations, and long-term value. Our strategy
for achieving our goal is to establish a diversified portfolio of
brands through a multi-faceted approach of both acquisition and
internal development."
KEY DEVELOPMENTS:
Vibativ Acquisition
On November 6, 2018, the Company
announced the acquisition of Vibativ® (telavancin) from
Theravance Biopharma. Vibativ is a patented, FDA approved
injectable anti-infective for the treatment of certain serious
bacterial infections including hospital-acquired and
ventilator-associated bacterial pneumonia and complicated skin and
skin structure infections. It addresses a range of Gram-positive
bacterial pathogens, including those that are considered
difficult-to-treat and multidrug-resistant.
Under the terms of the agreement, which closed on November 12, 2018, Cumberland assumed full responsibility for the
product including its marketing, distribution, manufacturing, and
regulatory activities. Cumberland
will support Vibativ in the U.S. through its established hospital
sales organization. The Company expects to selectively expand its
sales force, medical science liaison and corporate teams to ensure
the needed support of Vibativ as well as its oncology and acute
care brands.
RediTrex Approval Submission
Also in November, the Company completed the submission and filed
with the FDA an application for the approval of its methotrexate
product line which is designed for treating patients with arthritis
and psoriasis. This filing follows two meetings held with the FDA
to discuss the approval pathway and requirements for the
submission. We now await FDA's determination of acceptance of the
submission for their review.
Caldolor Submission
In early 2018, the Company completed and filed the application
for FDA approval of its Next Generation Caldolor product featuring
an improved package and formulation. On August 2, 2018, Cumberland received a complete response from
the FDA outlining the additional information needed for the
application's approval. The requests were for additional quality
and nonclinical data. The Company held a teleconference with
the FDA during the third quarter to discuss their additional
requirements. On September 26, 2018,
Cumberland submitted an amendment
to its application containing additional quality and nonclinical
data and now awaits the FDA's response and approval decision.
New Clinical Data Published
In September 2018, the Company
announced a new publication in Lung Cancer: Targets and
Therapy of a contemporary retrospective series showing that
subcutaneous amifostine administered before radiotherapy postponed
the onset of acute esophagitis in stage 3 small cell lung cancer
patients. Cumberland markets
branded amifostine in the U.S. territory under the name Ethyol.
Cumberland also announced two
favorable Caldolor study publications. A study at The Ohio State
Wexner Medical Center, published in the Journal Frontiers in
Surgery, reveals more effective pain control and opioid-sparing
activity with Caldolor when compared to ketorolac in patients
undergoing arthroscopic knee surgery.
Additionally, a clinical trial conducted at Tufts University School of Dental Medicine and
published online in the Journal of Oral and Maxillofacial
Surgery concluded that preemptive analgesia with Caldolor (IV
ibuprofen) is more effective than IV acetaminophen in reducing both
post-surgical pain and opioid use.
Ifetroban Phase II Studies
During the third quarter, we completed study enrollment for
Portaban - the Company's Portal Hypertension clinical program.
Portaban is a form of ifetroban and is in development for the
treatment of the portal hypertension associated with liver disease.
This study was primarily designed to evaluate the safety of
ifetroban treatment in this population and was not powered for any
efficacy measurement.
An initial review of the data from the study shows ifetroban was
safe and well tolerated with no unexpected safety findings. We also
measured hepatic venous pressure. Patients enrolled had a greater
degree of variability than expected in their hepatic venous
pressure gradient, therefore no definitive conclusions could be
made on the impact of ifetroban on modulating that gradient.
A full analysis of the data to include biomarkers and
exploratory endpoints is ongoing. We will now await results from
our other Phase II ifetroban studies before deciding on the best
path for approval of our first new chemical entity.
Cumberland also continued to
advance its Vasculan and Boxaban clinical pipeline programs, with
patient enrollment progressing in each of those Phase II
studies.
New CET Small Business Grant Award
CET announced that the U.S. National Cancer Institute awarded
$2 million in support of a joint
research program involving Cumberland Pharmaceuticals, CET, and
researchers at Vanderbilt University.
This Phase II grant is awarded under the Small Business Innovation
Research funding mechanism and follows successful completion of an
initial Phase I award.
The objective of the collaborative research program is to
further develop a novel small molecule radiosensitizing agent for
the treatment of certain lung cancers. By enhancing the cancer's
sensitivity to radiation therapy, this technology addresses a
significant medical need of improving clinical outcomes for these
oncology patients.
New Board Member
At Cumberland's Board meeting
in September, the Company appointed Joseph
C. Galante, American music industry executive, as its newest
member of its Board of Directors. Mr. Galante is the former
Chairman of Sony Music in Nashville and the Former President of RCA
Records in New York City.
Mr. Galante joins as the Company's seventh "independent
director" as defined under applicable SEC and NASDAQ rules and he
serves on the Company's Audit and Compensation Committees. Mr.
Galante's successful business track record, entrepreneurial and
public company experience make him a valuable new member to
Cumberland's Board of
Directors.
FINANCIAL RESULTS:
Net Revenue: For the nine months ended September 30,
2018, net revenues were $27.2 million
compared to $29.5 million for the
nine months ended September 30, 2017. The major driver of this
decrease was the significant sales of Totect last year resulting
from a competitive drug shortage.
For the three months ended September 30, 2018, net revenues
were $8.5 million, compared to
$11.2 million for the prior year
period.
Net revenue by product for the three months ended
September 30, 2018, included $3.0
million for Kristalose® and $2.6 million for Ethyol®. Net revenue
for the Company's other brands included $1.3
million for Caldolor®, $1.1 million for Acetadote® (including
the brand and Company's Authorized Generic), and $0.3 million for Omeclamox®-Pak.
Operating Expenses: Total operating expenses for
the first nine months of 2018 were $32.4
million compared to $32.7
million for 2017.
Total operating expenses for the three months ended
September 30, 2018 were $10.3
million, compared to $12.0
million during the prior year period.
Earnings: Net income (loss) for the third quarter
2018 was $(1.6) million or
$(0.11) per diluted share, compared
to $(0.7) million or $(0.05) a share for the prior year period.
Adjusted Earnings (loss) for the third quarter were $(0.8) million or $(0.05) per diluted share, compared to
$0.1 million or $0.01 per diluted share for the prior year
period. The definition and reconciliation of Adjusted Earnings to
net income is provided in this release.
Balance Sheet: At September 30, 2018,
Cumberland had $47.8 million in cash and marketable securities,
including approximately $38.3 million
in cash and equivalents. Total assets at September 30, 2018
were $87.4 million. Total
liabilities were $29.5 million,
including $12.0 million outstanding
on the Company's revolving line of credit, resulting in Total
shareholder's equity of $58.2
million.
Cumberland also has
approximately $44 million in tax net
operating loss carryforwards, resulting from the prior exercise of
stock options.
Conference Call and Webcast
A conference call and live Internet webcast will be held on
Tuesday, November 13, 2018 at
4:30 p.m. Eastern Time to discuss the
Company's third quarter 2018 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 4258737. 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 delivery of high-quality prescription brands
to improve patient care. The Company develops, acquires, and
commercializes brands for the hospital acute care,
gastroenterology, and oncology market segments. These medical
specialties are categorized by moderately concentrated prescriber
bases that we believe can be penetrated effectively by small,
targeted sales forces.
The Company's portfolio of FDA approved brands includes:
- Acetadote® (acetylcysteine) Injection,
for the treatment of acetaminophen poisoning;
- Caldolor® (ibuprofen) Injection, for
the treatment of pain and fever;
- Kristalose® (lactulose) for Oral
Solution, a prescription laxative, for the treatment of chronic and
acute constipation;
- Omeclamox®-Pak, (omeprazole,
clarithromycin, amoxicillin) for the treatment of Helicobacter
pylori (H. pylori) infection and related duodenal ulcer
disease;
- Vaprisol® (conivaptan) Injection, to
raise serum sodium levels in hospitalized patients with euvolemic
and hypervolemic hyponatremia;
- Ethyol® (amifostine) Injection, for
the reduction of xerostomia (dry mouth) in patients undergoing
post-operative radiation treatment for head and neck cancer and the
renal toxicity associated with the administration of cisplatin in
patients with advanced ovarian cancer;
- Totect® (dexrazoxane hydrochloride)
Injection, for emergency oncology intervention, to treat the toxic
effects of anthracycline chemotherapy in case of extravasation
(drug leakage from the bloodstream into the tissues); and
- Vibativ® (telavancin) Injection, for
the treatment of certain serious bacterial infections including
hospital-acquired and ventilator-associated bacterial pneumonia, as
well as complicated skin and skin structure infections.
Cumberland's pipeline of
product candidates includes:
- Hepatoren® (ifetroban) Injection, a
Phase II candidate for the treatment of critically ill patients
suffering from liver and kidney failure associated with hepatorenal
syndrome ("HRS");
- Boxaban® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of asthma patients with
aspirin-exacerbated respiratory disease ("AERD");
- Vasculan® (ifetroban) Oral Capsules, a
Phase II candidate for the treatment of patients with the systemic
sclerosis (SSc) form of autoimmune disease;
- Portaban® (ifetroban) Injection and
Oral Capsules, a Phase II candidate for the treatment of patients
with portal hypertension associated with liver disease; and
- RediTrexTM (methotrexate) Injection,
an approval submission candidate for the treatment of active
rheumatoid, juvenile idiopathic and severe psoriatic arthritis, as
well as disabling psoriasis.
For more information on Cumberland's approved products, including full
prescribing information, please visit the individual product
websites, links to which can be found on the Company's website
www.cumberlandpharma.com.
About Acetadote® (acetylcysteine)
Injection
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 U.S. 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® (ibuprofen) Injection
Caldolor is indicated in adults and pediatric patients 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. 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 a history of asthma or other 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® (lactulose) Oral
Solution
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.
About Omeclamox®-Pak (omeprazole, clarithromycin,
amoxicillin)
Omeprazole is an antisecretory drug, which works by decreasing
the amount of acid the stomach produces. Clarithromycin and
amoxicillin are antibacterial drugs, which inhibit the growth of
bacteria allowing the stomach lining to heal. Omeclamox-Pak is
contraindicated in patients with a history of hypersensitivity to
omeprazole, any macrolide antibiotic or penicillin. The safety and
effectiveness of Omeclamox-Pak in the pediatric population has not
yet been established. Omeclamox-Pak was approved by the FDA in
2011. For full prescribing information, visit
www.omeclamox.com.
About Vaprisol® (conivaptan hydrochloride)
Injection
Vaprisol is an intravenous treatment for hyponatremia used in
the critical care setting. Hyponatremia is an electrolyte
disturbance in which sodium ion concentration in blood plasma is
lower than normal.
This can be associated with a variety of critical care
conditions including congestive heart failure, liver failure,
kidney failure and pneumonia. The product is a vasopressin
receptor antagonist that raises serum sodium levels and promotes
free water secretion. Vaprisol was approved by the FDA in 2005 for
euvolemic hyponatremia and in 2007 for hypervolemic hyponatremia.
For full prescribing information, visit www.vaprisol.com.
About Ethyol® (amifostine) Injection
Ethyol is indicated to reduce the cumulative renal toxicity
associated with repeated administration of cisplatin in patients
with advanced ovarian cancer. It is indicated to reduce the
incidence of moderate to severe xerostomia in patients undergoing
post-operative radiation treatment for head and neck cancer, where
the radiation port includes a substantial portion of the parotid
glands. For more information please visit www.ethyol.com.
About Totect® (dexrazoxane) Injection
Totect is an anthracycline extravasation agent approved by the
FDA. Anthracyclines are used to treat many types of cancer and are
among the most common cancer therapies.
Anthracycline extravasation occurs when there is accidental
leaking of the intravenously-administered medication into the
surrounding tissues. Anthracycline extravasation can result
in serious complications for cancer patients including tissue
necrosis with skin ulceration. In addition to tissue damage, an
anthracycline extravasation may cause damage to the nerves,
tendons, muscle, and joints. For more information please visit
www.totect.com.
About Vibativ® (telavancin) Injection
Vibativ is an FDA-approved antibiotic used in the treatment of
certain serious bacterial infections including hospital-acquired
and ventilator-associated bacterial pneumonia (HABP/VABP), as well
as complicated skin and skin structure infections (cSSSI).
This lifesaving antibiotic is designed for difficult to treat
Gram-positive bacterial infections, including those that are
considered multidrug-resistant. For more information please
visit www.vibativ.com.
About Cumberland Emerging Technologies (CET)
Cumberland Emerging Technologies, Inc. (www.cet-fund.com) is a
joint initiative between Cumberland Pharmaceuticals Inc.,
Vanderbilt University, LaunchTN, and
Gloria Pharmaceuticals. The mission of CET is to advance biomedical
technologies and products conceived at Vanderbilt University and other regional research
centers towards the marketplace. CET helps manage the development
and commercialization process for select projects, and provides
expertise on intellectual property, regulatory, manufacturing and
marketing issues that are critical to successful new biomedical
products. CET's Life Sciences Center, provides laboratory space,
equipment and infrastructure for CET's activities and other
early-stage life sciences ventures.
Competition
The pharmaceutical industry is characterized by intense
competition and rapid innovation. Cumberland is devoted to providing advanced
products that improve value of care for patients and address unmet
or poorly met medical needs. We promote our approved products
through our hospital and gastroenterology sales forces in
the United States and are
launching a network of relationships with international partners to
bring our products to patients in their countries. Our continued
success in developing and commercializing pharmaceutical products
will depend, in part, upon our ability to compete against existing
and future products in our target markets.
Forward-Looking Statements
This release contains forward-looking statements within the
meaning of the federal securities laws, which are subject to
certain risks and reflect Cumberland's current views on future events
based on what it believes are reasonable assumptions. These
forward-looking statements involve certain risks and uncertainties,
and actual results may differ materially from them. Some important
factors which may cause results to differ from expectations
include: market conditions, competition, an inability of
manufacturers to supply Cumberland's products on a timely basis or
failure of manufacturers to comply with regulations applicable to
pharmaceutical manufacturers including quality control obligation,
maintaining an effective sales and marketing infrastructure,
availability of additional debt and equity capital required to
finance the business, market conditions at the time additional
capital is required, our ability to continue to acquire brands,
product sales, management of our growth and integration of our
acquisitions, as well as other risks discussed in the "Risk
Factors" section of the Company's most recent Annual Report on Form
10-K, and other filings 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)
|
|
|
September 30,
2018
|
|
December 31,
2017
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
38,259,233
|
|
|
$
|
45,412,868
|
|
Marketable
securities
|
9,533,703
|
|
|
4,672,476
|
|
Accounts receivable,
net
|
7,055,138
|
|
|
8,395,112
|
|
Inventories,
net
|
6,426,429
|
|
|
6,737,848
|
|
Other current
assets
|
2,351,708
|
|
|
3,466,541
|
|
Total current
assets
|
63,626,211
|
|
|
68,684,845
|
|
Property and
equipment, net
|
539,019
|
|
|
528,882
|
|
Intangible assets,
net
|
20,370,330
|
|
|
21,444,545
|
|
Deferred tax assets,
net
|
87,210
|
|
|
87,210
|
|
Other
assets
|
2,809,306
|
|
|
2,486,830
|
|
Total
assets
|
$
|
87,432,076
|
|
|
$
|
93,232,312
|
|
LIABILITIES AND
EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
8,447,429
|
|
|
$
|
8,979,929
|
|
Other current
liabilities
|
7,070,860
|
|
|
8,714,814
|
|
Total current
liabilities
|
15,518,289
|
|
|
17,694,743
|
|
Revolving line of
credit
|
12,000,000
|
|
|
9,800,000
|
|
Other long-term
liabilities
|
1,969,174
|
|
|
1,815,968
|
|
Total
liabilities
|
29,487,463
|
|
|
29,310,711
|
|
Commitments and
contingencies
|
|
|
|
Equity:
|
|
|
|
Shareholders'
equity:
|
|
|
|
Common stock—no par
value; 100,000,000 shares authorized; 15,555,865
and 15,723,075 shares issued and outstanding as of September 30,
2018 and
December 31, 2017, respectively
|
51,235,612
|
|
|
52,410,941
|
|
Retained
earnings
|
6,966,252
|
|
|
11,709,222
|
|
Total shareholders'
equity
|
58,201,864
|
|
|
64,120,163
|
|
Noncontrolling
interests
|
(257,251)
|
|
|
(198,562)
|
|
Total
equity
|
57,944,613
|
|
|
63,921,601
|
|
Total liabilities and
equity
|
$
|
87,432,076
|
|
|
$
|
93,232,312
|
|
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
|
Condensed
Consolidated Statements of Operations and Comprehensive Income
(loss)
|
(Unaudited)
|
|
|
Three months ended
September 30,
|
|
Nine months ended
September 30,
|
|
2018
|
|
2017
|
|
2018
|
|
2017
|
Net
revenues
|
$
|
8,492,530
|
|
|
$
|
11,196,961
|
|
|
$
|
27,243,859
|
|
|
$
|
29,500,843
|
|
Costs and
expenses:
|
|
|
|
|
|
|
|
Cost of products
sold
|
1,460,463
|
|
|
2,166,353
|
|
|
4,511,743
|
|
|
5,216,776
|
|
Selling and
marketing
|
4,803,112
|
|
|
6,226,438
|
|
|
14,549,873
|
|
|
16,174,391
|
|
Research and
development
|
1,306,055
|
|
|
943,162
|
|
|
4,631,384
|
|
|
2,921,951
|
|
General and
administrative
|
2,067,981
|
|
|
2,090,785
|
|
|
6,732,485
|
|
|
6,554,158
|
|
Amortization
|
661,802
|
|
|
609,572
|
|
|
1,946,457
|
|
|
1,811,589
|
|
Total costs and
expenses
|
10,299,413
|
|
|
12,036,310
|
|
|
32,371,942
|
|
|
32,678,865
|
|
Operating income
(loss)
|
(1,806,883)
|
|
|
(839,349)
|
|
|
(5,128,083)
|
|
|
(3,178,022)
|
|
Interest
income
|
166,220
|
|
|
94,833
|
|
|
398,420
|
|
|
216,849
|
|
Interest
expense
|
(19,199)
|
|
|
(8,902)
|
|
|
(59,520)
|
|
|
(70,646)
|
|
Income (loss) before
income taxes
|
(1,659,862)
|
|
|
(753,418)
|
|
|
(4,789,183)
|
|
|
(3,031,819)
|
|
Income tax (expense)
benefit
|
(4,159)
|
|
|
(3,822)
|
|
|
(12,477)
|
|
|
(4,196,192)
|
|
Net income
(loss)
|
(1,664,021)
|
|
|
(757,240)
|
|
|
(4,801,660)
|
|
|
(7,228,011)
|
|
Net loss at
subsidiary attributable to noncontrolling interests
|
20,977
|
|
|
14,209
|
|
|
58,689
|
|
|
49,923
|
|
Net income (loss)
attributable to common shareholders
|
$
|
(1,643,044)
|
|
|
$
|
(743,031)
|
|
|
$
|
(4,742,971)
|
|
|
$
|
(7,178,088)
|
|
Earnings (loss) per
share attributable to common shareholders
|
|
|
|
|
|
|
|
- basic
|
$
|
(0.11)
|
|
|
$
|
(0.05)
|
|
|
$
|
(0.30)
|
|
|
$
|
(0.45)
|
|
- diluted
|
$
|
(0.11)
|
|
|
$
|
(0.05)
|
|
|
$
|
(0.30)
|
|
|
$
|
(0.45)
|
|
Weighted-average
shares outstanding
|
|
|
|
|
|
|
|
- basic
|
15,573,108
|
|
|
15,867,159
|
|
|
15,645,230
|
|
|
15,973,737
|
|
- diluted
|
15,573,108
|
|
|
15,867,159
|
|
|
15,645,230
|
|
|
15,973,737
|
|
|
|
|
|
|
|
|
|
Comprehensive income
(loss) attributable to common shareholders
|
(1,643,044)
|
|
|
(743,031)
|
|
|
(4,742,971)
|
|
|
(7,178,088)
|
|
Net loss at
subsidiary attributable to noncontrolling interests
|
20,977
|
|
|
14,209
|
|
|
58,689
|
|
|
49,923
|
|
Total Comprehensive
income (loss)
|
$
|
(1,664,021)
|
|
|
$
|
(757,240)
|
|
|
$
|
(4,801,660)
|
|
|
$
|
(7,228,011)
|
|
|
|
|
|
|
|
|
|
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
|
Condensed
Consolidated Statements of Cash Flows
|
(Unaudited)
|
|
|
Nine months ended
September 30,
|
|
2018
|
|
2017
|
Cash flows from
operating activities:
|
|
|
|
Net income
(loss)
|
$
|
(4,801,660)
|
|
|
$
|
(7,228,011)
|
|
Adjustments to
reconcile net income (loss) to net cash provided by (used in)
operating activities:
|
|
|
|
Depreciation and
amortization expense
|
2,108,051
|
|
|
1,974,194
|
|
Deferred tax
expense
|
—
|
|
|
4,293,963
|
|
Share-based
compensation
|
1,005,239
|
|
|
849,198
|
|
Excess tax (benefit)
expense derived from exercise of stock options
|
—
|
|
|
(91,109)
|
|
Noncash interest
expense
|
44,117
|
|
|
60,708
|
|
Noncash investment
gains
|
(131,652)
|
|
|
(48,084)
|
|
Net changes in assets
and liabilities affecting operating activities:
|
|
|
|
Accounts
receivable
|
1,339,974
|
|
|
124,748
|
|
Inventory
|
311,419
|
|
|
(485,739)
|
|
Other current assets
and other assets
|
966,817
|
|
|
(428,176)
|
|
Accounts payable and
other current liabilities
|
(1,595,243)
|
|
|
640,453
|
|
Other long-term
liabilities
|
142,486
|
|
|
239,703
|
|
Net cash provided by
(used in) operating activities
|
(610,452)
|
|
|
(98,152)
|
|
Cash flows from
investing activities:
|
|
|
|
Additions to property
and equipment
|
(171,731)
|
|
|
(172,899)
|
|
Purchases of
marketable securities
|
(20,851,951)
|
|
|
(2,029,414)
|
|
Proceeds from sale of
marketable securities
|
16,122,376
|
|
|
9,644,592
|
|
Additions to
intangibles
|
(1,411,710)
|
|
|
(841,647)
|
|
Net cash used in
investment activities
|
(6,313,016)
|
|
|
6,600,632
|
|
Cash flows from
financing activities:
|
|
|
|
Borrowings on line of
credit
|
36,000,000
|
|
|
14,700,000
|
|
Repayments on line of
credit
|
(33,800,000)
|
|
|
(10,800,000)
|
|
Sales of shares of
common stock
|
200,909
|
|
|
—
|
|
Payments of deferred
offering costs
|
(248,108)
|
|
|
—
|
|
Payments made in
connection with repurchase of common shares
|
(2,382,968)
|
|
|
(2,893,857)
|
|
Net cash used in
financing activities
|
(230,167)
|
|
|
1,006,143
|
|
Net (decrease)
increase in cash and cash equivalents
|
(7,153,635)
|
|
|
7,508,623
|
|
Cash and cash
equivalents at beginning of period
|
45,412,868
|
|
|
34,510,330
|
|
Cash and cash
equivalents at end of period
|
$
|
38,259,233
|
|
|
$
|
42,018,953
|
|
CUMBERLAND
PHARMACEUTICALS INC. AND SUBSIDIARIES
|
Reconciliation of Net
Income (loss) Attributable to Common Shareholders to Adjusted
Earnings and Adjusted Diluted Earnings Per Share
|
(Unaudited)
|
|
|
|
Three months
ended
September 30, 2018
|
|
Three months
ended
September 30, 2017
|
|
|
Earnings
impact
|
|
Earnings per
share impact
|
|
Earnings
impact
|
|
Earnings per
share impact
|
Net income (loss)
attributable to common shareholders
|
|
$
|
(1,643,044)
|
|
|
$
|
(0.11)
|
|
|
$
|
(743,031)
|
|
|
$
|
(0.05)
|
|
Less: Net loss at
subsidiary attributable to noncontrolling
interests
|
|
20,977
|
|
|
—
|
|
|
14,209
|
|
|
—
|
|
Net income
(loss)
|
|
(1,664,021)
|
|
|
(0.11)
|
|
|
(757,240)
|
|
|
(0.05)
|
|
Adjustments to net
income (loss)
|
|
|
|
|
|
|
|
|
Income tax
expense
|
|
4,159
|
|
|
—
|
|
|
3,822
|
|
|
—
|
|
Depreciation and
amortization
|
|
713,323
|
|
|
0.05
|
|
|
659,901
|
|
|
0.04
|
|
Share-based
compensation (a)
|
|
339,930
|
|
|
0.02
|
|
|
297,943
|
|
|
0.02
|
|
Interest
income
|
|
(166,220)
|
|
|
(0.01)
|
|
|
(94,833)
|
|
|
(0.01)
|
|
Interest
expense
|
|
19,199
|
|
|
—
|
|
|
8,902
|
|
|
—
|
|
Adjusted Earnings
(loss) and Adjusted Diluted
Earnings (loss) Per Share
|
|
$
|
(753,630)
|
|
|
$
|
(0.05)
|
|
|
$
|
118,495
|
|
|
$
|
0.01
|
|
|
|
|
|
|
|
|
|
|
Diluted
weighted-average common shares outstanding:
|
|
|
|
15,573,108
|
|
|
|
|
16,280,883
|
|
|
(a) Represents the
share-based compensation of Cumberland.
|
The Company provided the above adjusted supplemental financial
performance measures, which are considered "non-GAAP" financial
measures under applicable SEC rules and regulations. These
financial measures should be considered supplemental to, and not as
a substitute for, financial information prepared in accordance with
Generally Accepted Accounting Principles ("GAAP"). The definition
of these supplemental measures may differ from similarly titled
measures used by others.
Because these supplemental financial measures exclude the effect
of items that will increase or decrease the Company's reported
results of operations, management encourages investors to review
the Company's consolidated financial statements and publicly filed
reports in their entirety. A reconciliation of the supplemental
financial measures to the most directly comparable GAAP financial
measures is included in the tables accompanying this release.
Cumberland's management
believes these supplemental financial performance measures are
important as they are used by management, along with financial
measures in accordance with GAAP, to evaluate the Company's
operating performance. In addition, Cumberland believes that they will be used by
certain investors to measure the Company's operating results.
Management believes that presenting these supplemental measures
provides useful information about the Company's underlying
performance across reporting periods on a consistent basis by
excluding items that Cumberland
does not believe are indicative of its core business performance or
reflect long-term strategic activities. Certain of these
items are not settled through cash payments and include:
depreciation, amortization, share-based compensation expense and
income taxes. Cumberland
utilizes its net operating loss carryforwards to pay minimal income
taxes. In addition, the use of these financial measures
provides greater transparency to investors of supplemental
information used by management in its financial and operational
decision-making, including the evaluation of the Company's
operating performance.
The Company defines these supplemental financial measures as
follows:
- Adjusted Earnings (loss): net income (loss) adjusted for
the impact of income taxes, depreciation and amortization expense,
share-based compensation and interest income and interest
expense.
- Adjusted Diluted Earnings (loss) Per Share: Adjusted
Earnings (loss) divided by diluted weighted-average common shares
outstanding.
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SOURCE Cumberland Pharmaceuticals Inc.