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Cumberland Pharmaceuticals Inc. (CPIX)

Q1 2017 Earnings Call· Mon, May 15, 2017

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Transcript

Executives

Management

Erin Smith - Corporate Relations A.J. Kazimi - Chief Executive Officer Martin Cearnal - Executive Vice President & Chief Commercial Officer Michael Bonner - Senior Director Finance & Accounting and Chief Financial Officer

Operator

Operator

Thank you for joining the Cumberland Pharmaceuticals First Quarter 2017 Financial Report and Company Update Conference Call. Please be advised that this call is being recorded at the company’s request and will be archived on Cumberland’s website for one week from today’s date. Now, I would like to introduce Erin Smith, who handles Corporate Relations for Cumberland Pharmaceuticals. Erin, please go ahead.

Erin Smith

Management

Good afternoon, everyone. Before we begin, I’d like to point out that earlier today the company issued a press release containing our financial results and update for the first quarter ended March 31, 2017. The release, including the financial tables is available on the company’s website at www.cumberlandpharma.com. I’d also like to share the following Safe Harbor language. This call may contain forward-looking statements within the meaning of the Private Securities Reform Act of 1995. Because they reflects the company’s current views and expectations concerning future events, these forward-looking statement may involve risks and uncertainties. Investors should note that many factors could affect the company’s future results, as more fully described under the caption Risk Factors in our form 10-K and any update filed with the SEC. Any forward-looking statements made during today’s call are qualified by those risk factors and our future results could differ materially from the views expressed in today’s call. We don’t assume any obligation to publicly update any forward-looking statements whether as a result of new information or future developments. Also, please note that today we’ll be providing some non-GAAP financial measures with respect to our performance and explanation and reconciliation to GAAP measures can be found in our earnings release and its financial tables. I’ll now turn the call over to our Chief Executive Officer, A.J. Kazimi, to begin our discussion of the company’s performance and plans.

A.J. Kazimi

Chief Executive Officer

Thank you, Erin. Good afternoon, everyone. Thanks for joining us as we review our first quarter 2017 results. We’re pleased with our recent progress and appreciate your participation in today’s call, as we share what’s happening here at Cumberland. Also with me on the call are Cumberland’s Chief Commercial Officer, Marty Cearnal; and our Chief Financial Officer, Michael Bonner. We’ll start with the discussion of recent developments, including our first quarter highlights and follow with an update on our commercial activities, then we’ll discuss our clinical programs and review our first quarter financial results. We’ll conclude with a discussion of the company’s strategy before then opening the call to any questions. As you’ll hear today, we continued on our course of building a company that offers its shareholders long-term sustainable growth. In the first quarter of 2017, our revenues of $9.6 million surged 25% compared to the prior year period. We were pleased to see our newest brand, Ethyol, off to a fine start this year, contributing over $3.7 million in sales during the first quarter. The addition of Ethyol has also enhanced our gross margin, which came in at nearly 86% for the quarter. We maintained our strong financial position with total assets at nearly $92 million, including over $50 million in cash and marketable securities at the end of the first quarter. Our adjusted earnings were $0.3 million, or $0.02 a share for the quarter similar to the prior year period, while cash flow from operations significantly increased to $1.4 million for the quarter. During the first quarter, we further expanded our commercial product line with the acquisition of exclusive U.S. rights to Totect and oncology support drug and second to emerge from alliance with Clinigen Group. Cumberland currently markets six FDA-approved brands and with Totect expected to…

Martin Cearnal

Chief Executive Officer

Thanks A.J. As A.J. mentioned, Cumberland is determined to maximize the potential of our existing brands. We held a successful national sales meeting during the first quarter to help support and equip our sales team towards this aim. At that meeting, our hospital and field sales representatives received preparation, guidance and new materials for their 2017 promotional efforts. We’ve also been pleased with the performance of our newest commercial brand, Ethyol. It’s an FDA approved hospital product used to support the care of oncology patients. Ethyol can reduce the adverse reactions to therapy, preventing interruptions in treatment and improving the quality of life for patients. If you’ve been following us for a while, you know, we’ve been working diligently to further strengthen Caldolor’s position in the marketplace. Caldolor is an injectable form of ibuprofen designed primarily for hospitalized patients who are not able to take their pain and fever medications orally. It was originally approved for use in adults for the management of pain and the reduction of fever. Last year, we launched the pediatric indication after gaining FDA approval for the use of Caldolor in children. There’ve been a series of publications on Caldolor during the first quarter of 2017. There were two new studies published in medical journals adding to the growing amount of literature in support of the safety and efficacy of the product. One study demonstrated Caldolor’s significant fever reduction capability in hospitalized children. That study found that a single 10 milligram per kilogram dose of Caldolor provides a safe and effective option for reducing fever in children. The publication became available as an open access article in the British BMC Pediatrics Journal. Another study provided evidence that Caldolor can significantly improve postoperative pain control, while also significantly reducing opioid use in patients undergoing transsphenoidal surgery. Results from the study were published in the Journal of Neurosurgery in March of 2017. Additionally, there was also a new study published by Vaprisol, our treatment for hyponatremia, an imbalance of serum sodium to body order and the most common electrolytes disorder among hospitalized patients. This study published in drug design, development and therapy demonstrated that Vaprisol was well tolerated in hyponatremic patients with severe hepatic impairment. Also, during the first quarter, we began planning for the launch of Totect. It’s an FDA approved product indicated to reverse the toxic effects of extravasation associated with anthracycline chemotherapy. Extravasation occurs when an injected medicine escapes from the blood vessels and circulates into surrounding tissues in the body. When this happens within anthracycline chemotherapy drug, it causes severe damage and serious complications. Totect can reverse such damage without the need for additional surgeries or procedures, enabling patients to continue their essential anti-cancer therapy. We’re excited to bring Totect to patients in the United States and are busy preparing the products launch, which is expected to occur later this year. That completes today’s updates on our commercial activities. A.J., I’ll turn the call back to you.

A.J. Kazimi

Chief Executive Officer

Thank you for that update, Marty. We’re certainly pleased with the growth in Ethyol sales, as the new sales initiatives you mentioned and the most recent manuscripts for our Caldolor and Vaprisol brands. Now, I’d like to discuss the clinical development efforts underway here at Cumberland. We previously reported on our agreement with the Nordic Group to acquire the exclusive U.S. rights to their injectable methotrexate product line. Nordic is a privately-owned European pharmaceutical company, that’s built a market leading position with their methotrexate products in several European countries. Methotrexate approved in the U.S. as a treatment for several diseases, including arthritis. And while oral formulations are available, injectable methotrexate has been shown to result in increased efficacy, greater continuation rates, and less discomfort for patients. We’ll be launching a line of injectable methotrexate products in the United States intended for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis, and severe psoriatic arthritis. These methotrexate products have been approved for use in Europe, but additional efforts are needed to prepare for the approval in the United States by the FDA. We’ve been busy developing the regulatory strategy and have begun preparation of the FDA submission for these products. We’ve received a significant amount of information from Nordic, including the European dossiers. Our goal is to finalize the U.S. approval submission hopefully by the end of the year, and we’ll keep you posted as this progresses. Meanwhile, our other development programs continue to advance with four promising candidates now in Phase II. Our first pipeline candidate is Hepatoren, an injectable formulation of ifetroban that we’re evaluating for patients with hepatorenal syndrome. Those patients suffer from progressive kidney and liver failure leading to a high-mortality rate, with no accrued treatment for their condition here in the United States. We completed the…

Michael Bonner

Chief Financial Officer

Thank you, A.J. For the three months ended March 31, 2017, net revenues were $9.6 million, growing 25% compared to the $7.7 million in the prior year period. Ethyol delivered $3.7 million of revenue in the first quarter, followed by $2.4 million for Kristalose and $1.3 million for Acetadote. Net revenues during the quarter were $0.8 million for Caldolor and $0.7 million for both Vaprisol and Omeclamox-Pak. We were very encouraged to see a significant increase in Ethyol sales and we continue to believe and become our largest selling product. Kristalose sales dropped off during the quarter after strong fourth quarter shipments. This is reflecting wholesaler buying patterns late last year. Domestic shipments of Caldolor continue to grow during the first quarter, but were offset by decrease in international shipments due to some manufacturing delays. Turning to our expenditures. Total operating expenses for the three months ended March 31, 2017 were $10.3 million compared to $8.2 million in the prior year period. The primary reasons for these increases were the additional cost of goods sold and royalties, both associated with the growth in sales. The net loss in the first quarter was $1.3 million, or $0.08 a share, compared to $0.3 million, or $0.02 a share in the prior year period. This difference was impacted by non-cash charge to taxes associated with an increase in the allowance for prior research and development tax credits. Adjusted earnings for the first quarter were $0.3 million, or $0.02 per share similar to the prior year period. We continue to manage our expenses in line with our revenues and our goal is profitability on an annual basis. During the first quarter, our balance sheet remained strong with total assets of $91.9 million, including over $50 million in cash and marketable securities. Liabilities at the…

A.J. Kazimi

Chief Executive Officer

Thanks, Michael. On a sad note in March Thomas Lawrence, our longest serving Independent and Lead Director passed away, following a brief illness. We value Tom’s contributions and we’ll miss his insight and counsel. Meanwhile, Joey Jacobs, the Chairman and Chief Executive of Acadia Healthcare has agreed to assume responsibility as our Lead Independent Director going forward. At our recent Shareholder Meeting – Annual Shareholder Meeting, all five proposals recommended were passed. Included in those proposals were amendments to the company’s incentive plans. Please note that these amendments only extended the terms for our previous plans, which were expiring. There was a question about the provisions in the plans involving repricing options and early cash out of restricted shares. Those provisions are no longer applicable, as we’ve discontinued the use of options as a form of equity awards and the company policy does not provide for such restricted cash – restricted share cash outs. So both are no longer applicable. While we’re working hard here to keep Cumberland on a solid foundation for long-term growth. We advanced that goal last year with a series of steps designed to maximize the potential of our approved products. We enhanced our marketing efforts, increased the number of sales reps detailing our products, expanded the product portfolio, advanced our clinical pipeline and defended our intellectual property. As we moved into 2017, those same initiatives remain our focus and we’re pleased that the New Year’s off to a very promising start. We recently announced a new co-promotion agreement for our Kristalose brand that will significantly increase the number of physicians that are covered in support of that product. Our partner, Poly Pharmaceuticals, is a privately-held specialty pharma company, with a field sales force actually slightly larger than ours. Under the terms of this new agreement,…

Operator

Operator

Thank you, sir. Ladies and gentlemen, that concludes the company’s presentation. We will now open the call for questions. [Operator Instructions]

A.J. Kazimi

Chief Executive Officer

Well, thank you, everyone, for joining us for today’s call. And we do understand that many of you prefer a private discussion with management, and please reach out to Erin Smith here if you’d like to hold such a call. We appreciate your time and interest in Cumberland, and look forward to providing another update following the end of the second quarter. Goodbye.

Operator

Operator

Ladies and gentlemen, that concludes our conference for today. If you would like to listen to a replay of today’s conference, please dial 855-859-2056 using the access code 11376419. Alternatively, a replay of the webcast will be available on the company’s website. I would like to thank you for your participation. You may now disconnect.

Q -

Analyst