Nov 5 2013
Cumberland Pharmaceuticals Inc. (NASDAQ: CPIX), a specialty pharmaceutical company focused on hospital acute care and gastroenterology, today announced third quarter 2013 financial results.
Net Revenue: For the three months ended September 30, 2013, net revenue was $6.5 million compared to $12.5 million for the prior year period. Net revenue was $3.8 million for Acetadote, $2.2 million for Kristalose and $0.5 million for Caldolor.
For the nine months ended September 30, 2013, net revenue was $23.9 million compared with $35.2 million for the nine months ended September 30, 2012.
Operating Expenses: Total operating expenses for the three months ended September 30, 2013, were $8.0 million compared to $9.6 million during the prior year period.
For the nine months ended September 30, 2013, operating expenses were $25.2 million compared to $29.6 million for the prior year period.
Net Income (Loss): Net income (loss) attributable to common shareholders for the three months ended September 30, 2013, was $(0.8) million, or $(0.04) per diluted share.
For the nine months ended September 30, 2013, net income attributable to common shareholders was $(0.6) million, or $(0.03) per diluted share.
Cash Flow: Operating cash flows for the nine months ended September 30, 2013, were $0.9 million, compared to $5.1 million, for the prior year period.
Balance Sheet: As of September 30, 2013, Cumberland had $65.2 million in cash and marketable securities, with approximately $46.0 million in cash and equivalents and $19.2 million in marketable securities. Total assets at September 30, 2013, were $91.9 million.
"The recent addition of Omeclamox-Pak reflects our commitment to the expansion of our product portfolio and to help improve patient care," said A.J. Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals. "This important new development also reflects the successful implementation of our strategic plan."
Product Highlights
Caldolor®
Posters with data from three Caldolor studies were presented at the Annual Meeting of the American Society of Anesthesiologists in San Francisco in October 2013. The poster presentations were presented by Dr. Alberto Uribe, Post-Doctoral Researcher, Department of Anesthesiology, Wexner Medical Center at the Ohio State University.
A poster entitled "Multicenter, Open-label Surveillance Trials to Evaluate the Safety and Efficacy of a Shortened Infusion Time of Intravenous Ibuprofen" was presented. Two registry studies made up this presentation. In the first registry study 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 registry study 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 of intravenous ibuprofen administered at induction of anesthesia and could continue Caldolor therapy for up to 24 hours. Three hundred patients from 21 clinical sites were enrolled in this study. The shortened infusion time was well tolerated.
Another poster presentation was entitled "A Pilot Study to Determine the Efficacy of Intravenous Ibuprofen for Pain Control Following Arthroscopic Knee Surgery." This 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 preemptive model of multimodal analgesia.
Omeclamox-Pak®
Cumberland recently announced an agreement with Pernix Therapeutics LLC for the promotion of Omeclamox-Pak covering the United States. Omeclamox-Pak is a branded prescription product that combines omeprazole, amoxicillin and clarithromycin for the treatment of Helicobacter pylori (H. pylori) infection and duodenal ulcer disease. It is the only FDA approved triple combination medication to contain omeprazole as the proton pump inhibitor and is prescribed over a shortened treatment period of ten days.
Under the terms of the agreement, Cumberland will promote the product to gastroenterologists across the United States through its field sales force, which also promotes its Kristalose brand. Pernix will promote the product through its specialty sales force focusing on select primary care physicians. The companies will cooperate in the marketing and other activities needed to support the commercialization of the brand.
Conference Call and Webcast
A conference call and live Internet webcast will be held on Tuesday, November 5, 2013 at 4:30 p.m. Eastern Time to discuss the Company's third 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 91716682. The live webcast and rebroadcast can be accessed via Cumberland's website at http://investor.shareholder.com/cpix/events.cfm.
Source: Cumberland Pharmaceuticals Inc.
It's official! Men and women experience and manage pain differently