News Release

NASHVILLE, Tenn., Aug. 14, 2018 /PRNewswire/ -- Cumberland Pharmaceuticals Inc.(NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care, gastroenterology, and oncology supportive care today announced second quarter 2018 financial results and Company update. Cumberland has a portfolio of seven U.S. Food and Drug Administration (FDA) approved brands. Net revenues for the quarter were $10.2 million, an increase of 17% over the prior year period and an 18% increase over the first quarter of this year.  At the end of the second quarter, Cumberland had $90 million in total assets, including approximately $51 million in cash and marketable securities.

QUARTER HIGHLIGHTS:

• New supplies of Vaprisol^® replenished nationwide supply of that critical care product designed to treat hyponatremia – the most common electrolyte imbalance found in hospitalized patients.
• Reached an agreement with Gastro-Entero-Logic, LLC (GEL) to acquire the assets associated with Omeclamox^®-Pak
• Completed patient enrollment in the initial Phase II clinical study for Portaban^® - the Company's product candidate for the treatment of Portal Hypertension
• Caldolor^® approved for sale in India with product launch preparations underway

"I am pleased to report several positive developments during the second quarter, with the most significant being the overall growth generated from our diversified portfolio of seven FDA approved brands," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "Furthermore, we continue to advance on our robust clinical pipeline, highlighted by the expected near-term NDA filing for our new methotrexate product line. We believe there is significant potential value in our clinical pipeline and its development remains a top priority for the company."

KEY DEVELOPMENTS:

GEL Agreement

In March 2018, Cumberland reached agreement with Gastro-Entero-Logic LLC, to acquire the assets associated with Omeclamox-Pak including the product's FDA approved New Drug Application, trademarks and other assets. As a result of this acquisition, the Company will no longer be obligated to provide GEL with royalties or fees for overseeing the product's manufacturing. As part of this transaction Cumberland will become responsible for maintaining the FDA approval and for overseeing the product's packaging.

Caldolor^® Submission

In early 2018, the Company completed and filed the application for FDA approval of its Next Generation Caldolor product.  During the second quarter, the FDA notified Cumberland of their acceptance of the submission for review. The product features a new, patented formulation in a more convenient to use package. There were then a number of communications with questions addressed through multiple amendments submitted to the application. On August 2, 2018 the FDA provided a complete response outlining additional information needed for the applications approval. The requests are for additional quality and nonclinical data. The next step involves discussion with the FDA and clarification on the additional requested items.

RediTrex™ Approval Submission

Cumberland is preparing to file its New Drug Application for the approval of the Company's methotrexate product line. This application follows two meetings held with the FDA to discuss the approval pathway and requirements for the submission.  Once the application is filed with the FDA, Cumberland will await the FDA's determination of acceptance of the submission for its review.

CET Collaboration Agreement

Cumberland Emerging Technologies (CET), Cumberland's majority-owned subsidiary, and Louisiana State University entered into an agreement, adding to CET's roster of academic collaborations which also includes Vanderbilt University, the University of Mississippi, and the University of Tennessee Research Foundation. These partnerships combine the strengths and capabilities of each organization by working together to identify, formulate, and develop attractive new biomedical products.

New Executive Appointment

The Company recently announced that biopharmaceutical industry veteran Adam Haeberle, Ph.D. joined as Senior Director, Clinical & Regulatory Affairs. Dr. Haeberle joined Cumberland from Amgen Inc., where he held a series of director level clinical development roles. At Amgen he led clinical development initiatives and held responsibility for innovating and increasing the overall efficiency of Amgen's cardiovascular portfolio.

Before Amgen, Dr. Haberle was Senior Manager, Clinical Development at Baxter Healthcare Corporation.  There he led clinical activities for Baxter's Alpha-1 Protease Inhibitor franchise and was a clinical representative for the approval submission of Baxter's immunodeficiency brand HyQVIA^® (immune globulin with hyaluronidase) and a subject matter expert for the acquisitions business development team.

FINANCIAL RESULTS:

Net Revenue:  For the three months ended June 30, 2018, net revenues were $10.2 million, compared to $8.7 million for the prior year period.  Net revenue by product for the three months ended June 30, 2018 included $3.2 million for Kristalose^® and $2.8 million for Ethyol^®. Net revenue for the Company's other brands were $1.7 million for Vaprisol^®, $1.1 million for Caldolor^®, $0.8 million for Acetadote^® (including the brand and Company's Authorized Generic), $0.3 million for Totect^®, and $0.1 million for Omeclamox^®-Pak.

For the six months ended June 30, 2018, net revenues were $18.8 million compared to $18.3 million for the six months ended June 30, 2017.

Operating Expenses:  Total operating expenses for the three months ended June 30, 2018 were $11.0 million, compared to $10.3 million during the prior year period. The primary reason for this increase is costs associated with the Company's Phase II clinical programs as well as royalties related to increased product sales.

Total operating expenses for the first six months of 2018 were $22.1 million compared to $20.6 million for 2017.

Earnings:  Net income (loss) for the second quarter 2018 was $(0.7) million or $(0.05) per diluted share, compared to $(5.2) million or $(0.32) a share for the prior year period.

Adjusted Earnings for the second quarter were $0.2 million or $0.01 per diluted share, compared to a loss of $(0.7) million or $(0.05) 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 June 30, 2018, Cumberland had $50.7 million in cash and marketable securities, including approximately $35.9 million in cash and equivalents. Total assets at June 30, 2018 were $90.4 million.  Total liabilities were $30.8 million, including $12.0 million outstanding on the Company's revolving line of credit, resulting in Total shareholder's equity of $59.9 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, August 14, 2018 at 4:30 p.m. Eastern Time to discuss the Company's second 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 6256649. 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).

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;
• RediTrex^™ (methotrexate) Injection, an approval submission candidate for the treatment of active rheumatoid, juvenile idiopathic and severe psoriatic arthritis.

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 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 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; availability of additional debt and equity capital required to finance the business model; market conditions at the time additional capital is required; our ability to continue to acquire branded products; 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.

 

 

 

 

 

 

 

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.

Investor Contact - Erin Smith, Corporate Relations, (615) 255-0068, Media Contact - Jeff Bradford, the Bradford Group, (615) 515-4880