Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q4 2016 Earnings Call· Tue, Mar 7, 2017

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Transcript

Operator

Operator

Thank you for joining the Cumberland Pharmaceuticals conference call covering the Company's fourth quarter and FY '16 financial results. Please note that this call is recorded at Cumberland's request and will be archived on the Company's website for one week from today. I would now like to hand the call over to Erin Smith, who handles Corporate Relations for Cumberland. Erin, please go ahead.

Erin Smith

Management

Good afternoon, everyone. Before we get started with a report from Management, I'd like to point out that earlier today we issued a press release summarizing our financial results for the fourth quarter and fiscal year ended December 31, 2016. You can find that release, including the financial tables, on the Company's website at www.cumberlandpharma.com. I would now like to note the following Safe Harbor language. This call may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Because any such statements reflect the Company's current views, expectations and beliefs concerning future events, these forward-looking statement may involve risks and uncertainties. Investors should note that many factors, as more fully described under the caption risk factors in our form 10-K, form 10-Q and form 8-K filings with the SEC, could affect the Company's future financial and operating results. Those future results could differ materially from those expressed in any forward-looking statements made today which are qualified by these risk factors. The Company doesn't assume any obligation to publicly update any such forward-looking statements whether as a result of new information, future developments or otherwise. Also, please note that we will be providing some non-GAAP financial measures with respect to our performance today. A reconciliation of this information to GAAP measures can be found in our earnings release and its related financial tables. With that background, I would now like to turn the call over to our Chief Executive Officer, AJ Kazimi, to begin the discussion of the Company's performance.

AJ Kazimi

Chief Executive Officer

Thank you, Erin. Hello, everyone. We appreciate your joining us as we review our fourth quarter and our FY '16 results. We'll also discuss recent developments, provide an update on our progress and share our outlook for 2017. With me on today's call are our Chief Commercial Officer, Marty Cearnal and Cumberland's Chief Financial Officer, Michael Bonner. As you will hear today, we were extremely busy during 2016, taking steps towards maximizing the potential of our marketed products, entering into a series of key agreements and furthering our clinical programs. We believe we have established a strong foundation taking us on a trajectory of sustainable growth. This past quarter we again posted double-digit revenue growth as the steps we have put in place over the past year are now beginning to yield results. As I mentioned last quarter, there are seven key operational pillars our people focus on every day. We strive to deliver on each of these goals and we expect them to generate revenue growth and profitability for years to come. First, we must support and expand the use of our six marketed brands; second, leverage our infrastructure through co-promotion partnerships; third, capitalize on our commercialization agreements with international partners; fourth, selectively add complementary brands; fifth, progress our clinical pipeline; sixth, continue to utilize CET as an incubator of future product opportunities; and last, prudently manage over expenditures. Our organization focuses on progressing each of these objectives and that is exactly what we did in 2016. Let's take a few minutes to review our accomplishments over the last four quarters. In late 2016, Cumberland acquired the rights, the U.S. rights, to a line of injectable methotrexate products from the Nordic Group. These products were designed for the treatment of active rheumatoid arthritis, juvenile idiopathic arthritis and disabling psoriasis.…

Marty Cearnal

Management

Thank you, AJ. We've worked diligently to further strengthen Caldolor position, a position of pediatric dosing. Caldolor was originally approved for use in adults for the management of pain and the reduction of fever. We then conducted a series of phase IV studies evaluating shortened infusion time, pre-surgical administration and the treatment of pain and fever in children. We submitted these study results to the FDA, including an expanded safety database which all led to the approval in children six months of age and older. We launched the sales promotion of the new pediatric indication early in 2016 and started the marketing process with a meeting of an advisory board comprised of prominent pediatric practitioners from across the country. We then identified the appropriate positioning and messaging and created a series of promotional tools to support the launch. We began by focusing on introducing Caldolor to the country's children's hospitals and then shifted to an approach that included both pediatric, as well as adult, surgeons and anesthesiologists. We also worked to expand the use of Caldolor in the enhanced recovery after surgery protocols being developed across the country. We have been pleased to see shipments of the product grow in 2016 and we continue to note new institutions stocking the product each month. Also in 2016, we modified the focus of our marketing communications for Vaprisol. It is our intravenous treatment for hyponatremia, the most common electrolyte imbalance seen in hospitalized patients. Hyponatremia can lead to poor patient outcomes and extended hospital stays and we're now using clinical data to target our communication to the relationship between hyponatremia and extended hospital stays and have started to see an impact on the growth of the product by using this model. Both Kristalose and Omeclamox, our two GI brands, have been steady…

AJ Kazimi

Chief Executive Officer

Thank you, Marty. Before we review our financial results, I'd like to discuss the clinical development efforts underway at Cumberland. As I previously mentioned, we have been working hard to provide new data in support of our Caldolor brand. We recently announced the publication of a new study manuscript highlighting how Caldolor can significantly reduce fevers in children. This study, published in the British BMC Pediatrics Journal, detailed the pivotal data that supported the FDA approval for Caldolor's pediatric indication. We have also now reached agreement with the FDA on the design of a new study evaluating the use of Caldolor in newborns and infants. That study is underway and will gather important new information on the use of Caldolor in these youngest of patients. Moving on to our development pipeline which is quite robust and collectively targets revenue market opportunities in the hundreds of millions of dollars, this is an area of the Company we're not sure investors fully appreciate. As you may recall, we have completed a phase II safety and pharmacokinetic study for Hepatoren. It's an injectable formulation of ifetroban we're evaluating for patients with hepatorenal syndrome. These patients suffer progressive from kidney and liver failure, leading to a very high mortality rate with no approved treatment for this condition here in the United States. The results from that first study were favorable, showing that ifetroban was well tolerated in these HRS patients. We've now completed that study report, filed those results with FDA and moved onto the design for a follow-on phase II efficacy study. We also continue to advance our Boxaban clinical program. Boxaban is an oral formulation of ifetroban designed for patients suffering from a severe form of asthma known as aspirin-exacerbated respiratory disease. We carefully reviewed the results of the initial phase II Botaban study, completed that study report and then submitted those results to the FDA. The design and plans for a follow-on study are well underway and with FDA clearance we will implement the next phase II trial which will be powered for efficacy. Additionally, we announced two new development programs this past year, Portaban, an oral formulation of ifetroban, indicated for patients with portal hypertension associated with their liver disease and Vasculan for the treatment of systemic sclerosis, a rare and life-threatening autoimmune disorder that involves a thickening of the skin and internal organs. We're initiating those two studies at centers of excellence across the country and now that we have FDA clearance for both program INDs, we're gearing up for patient enrollments. That completes the clinical update. I will now look to our Chief Financial Officer, Michael Bonner, for the financial review. Michael?

Michael Bonner

Chief Financial Officer

Thank you, AJ. For the three months ended December 31, 2016, net revenues were $9.1 million, a 13% increase compared to $8 million for the prior-year period. Net revenues by product for the fourth quarter were $5 million for Kristalose, $1.7 million for Acetadote, including $1.2 million of our authorized generic, $1.1 million for Caldolor, $0.6 million for Vaprisol, $0.4 million for Omeclamox and $0.3 million for Ethyol. For the full year ended December 31, 2016, Cumberland's total net revenues were $33 million, similar to the levels in the prior year. Net revenues by product in 2016 were $15.9 million for Kristalose, $7.2 million for Acetadote, including $4.8 million of our authorized generic, $4.1 million for Caldolor, $2.5 million for Omeclamox, $1.9 million for Vaprisol and $0.8 million for Ethyol. Total operating expenses for the three months ended December 31, 2016, were $10 million compared to $7.9 million for the prior-year period. This increase included additional royalties and supply cost associated with the growth in product sales, as well as our increasing investment in our clinical pipeline. For the year ended December 31, 2016, our total operating expenses were $34.5 million compared to $32.4 billion for 2015. Adjusted earnings for 2016 were $1.8 million, or $0.11 per share, compared to $4.5 million in 2015, or $0.26 per share. As of December 31, 2016, we had $93.4 million in total assets, including $50.1 million in cash and marketable securities. Liabilities totaled $20.3 million, including $4.1 million on our credit facility at the end of the quarter. Total shareholders equity was $73.2 million at the end of the period. Meanwhile, we continued the Company's share repurchase program. During the fourth quarter we repurchased another 121,855 Cumberland shares, bringing the 2016 total to 529,312 shares. I would like to note the new rules…

AJ Kazimi

Chief Executive Officer

Thanks, Michael. As you have heard today, we advanced on each of our seven key pillars of growth in 2016 which we believe will pave the way for a successful 2017 and beyond. Our sales and marketing team is working to support and maximize the potential of our commercial brands. The Caldolor pediatric launch, the Piramal promotional support and the launch of our sixth commercial product, Ethyol, all represent important growth drivers for our Company. Our development and regulatory team is sharply focused on progressing our pipeline which can provide additional milestones and catalysts as new data becomes available. Our business development colleagues will continue their efforts on initiatives to seek more co-promotion partners and select additions to our portfolio. Please note they have delivered three acquisitions in the last 12 months. We'll also manage our expenses in line with revenues to deliver profits and positive cash flow from operations. We continue to believe our shares are significantly undervalued and represent an attractive investment opportunity, as evidenced by our ongoing share repurchase program. Moreover, we remain in a strong financial position with high margins, a clean balance sheet and little debt. Supported by the strength of our financial position and an outstanding Cumberland team, we're well positioned as we enter 2017. Our guidance reflects the confidence we have in our business and our ability to execute on our key pillars of growth. As an organization we remain dedicated to our mission of advancing patient care through the delivery of high-quality pharmaceutical products. With that, now let's open the call to any questions you may have. Operator, please proceed.

Operator

Operator

AJ Kazimi

Chief Executive Officer

Okay, well, thank you everyone for joining us on the call today. We understand that some of you do prefer a private discussion with Management and we're prepared to do so. Just reach out to Erin Smith here if you would like to hold such a call. We do appreciate your time and your interest in our Company and we look forward to providing another update after the end of the first quarter. Goodbye.

Operator

Operator

Thank you, sir. 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 69461781. 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.