Erin Smith - Corporate Relations Marty Cearnal - Chief Commercial Officer Michael Bonner - CFO AJ Kazimi - CEO.

Analysts:.

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. .

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. .

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. These products have performed very well in Europe and Cumberland will be responsible for their registration and commercialization here in the United States.

Also in 2016, we made significant progress with our Caldolor brand. We expanded the product's reach following FDA's approval for its use in children and we kicked off our sales initiatives for that indication.

We also leverage our existing infrastructure through a co-promotion agreement with Piramal Critical Care and through this partnership both our Caldolor and Vaprisol brands are being featured in an expanded number of hospitals throughout the United States.

Additionally, we acquired Ethyol, our first oncology product and the initial brand to emerge from our lines with the Clinigen Group. Ethyol is an FDA-approved product used in the care of oncology patients and a nice complement to our hospital product line.

We then launched our newest brand, introducing it to oncologists supporting select patients undergoing radiation treatment and those undergoing chemotherapy for certain cancers.

We also continued to advance our Hepatoren and Boxaban clinical programs and announced the expansion of our pipeline in 2016 with the addition of two new drug candidates, Vasculan, for the treatment of systemic sclerosis and Portaban, for the treatment of portal hypertension. We added Caroline Young to our Board of Directors the past year.

Caroline's the former President of the National Health Care Council, an association of the largest concentration of health care companies in the United States and her extensive health care, biotechnology and international experience has made her a great addition to our Board.

We believe these key developments have helped position Cumberland for significant long term growth and have led to a fast start here in 2017. We entered the year with great excitement that our path forward is on the right track.

So far in 2017 we have acquired rights to another FDA-approved brand, we have successfully defended our Acetadote patent and we've added another Board member and we're just getting started. I would now like to look to Marty Cearnal, Cumberland's Chief Commercial Officer, to provide you with an update on our marketed products.

Marty?.

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 contributors this past year and have continued to benefit from our marketing initiatives which include improved managed care coverage, co-pay coupons programs and more targeted pharmacy support.

Lastly, I am pleased to report in late 2016 we began generating our first sales contributions from our newest product, Ethyol, following its launch. The ramp in these sales was delayed as we awaited the delivery of launch supply and movement of our product through the distribution channels.

We're encouraged by the recent growth in shipments and we believe that this new product can become our largest selling brand. Ethyol, or amifostine for injection, is an FDA-approved hospital product used to support the care of oncology patients.

It is a cytoprotective agent indicated to support select patients undergoing radiation treatment, as well as those undergoing chemotherapy for certain cancers. For the last several years, no company has been educating physicians on the benefit of this product for their patients.

While many centers across the country remain committed to the product, we have seen an opportunity to expand the current level of use by reintroducing Ethyol to a brand-new generation of oncologists, initially at centers already prescribing amifostine. That completes the update on marketed products. AJ, I'll turn the call back over to you. .

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?.

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 issued by the Financial Accounting Standards Board became effective January 1, 2017, impacting the accounting for stock compensation.

The guidance includes multiple provisions intended to simplify various aspects of the accounting for share-based dynamics. While aimed at reducing the cost and complexity of the accounting for share-based payments, the amendments are expected to potentially impact net income, earnings per share, the balance sheet and the statement of cash flows.

One of the impacts to the Company which we have evaluated is the addition as a new asset on our balance sheet for the tax loss carry forwards generated from the prior exercise of stock options.

Under the previous accounting guidance, these assets were excluded from the balance sheet, despite their significant value to the Company and reducing the amount of our income taxes.

The implementation of this new accounting also involves the impact to our existing research and development tax credits, some of which expire by 2021 and implementation of these accounting changes prior to the release -- we will complete our evaluation and implementation of these accounting changes prior to the release of our Q1 2017 financial statements.

Please keep in mind that these net assets from the exercise of stock options and the research and development tax credits will result in the Company continuing to pay minimal cash income taxes over the next several years. I would also like to note that we were very encouraged with the positive revenue trends seen during the second half of 2016.

We experienced double-digit year-over-year and double-digit sequential revenue growth in both Q3 and Q4 2016. We're on pace to continue those double-digit growth trends in 2017, as well. Of our six marketed products, we expect the most robust growth to come from Ethyol and Caldolor.

We're particularly excited about the prospects for Ethyol and believe it has the potential to become our largest selling brand. From an expense standpoint, we expect an increase in our variable expenses such as cost of goods, royalty and distribution.

We also plan to incur additional research and development costs as we invest in the key studies for our new product candidates and prepare the FDA submission for our new injectable methotrexate product lines.

Despite the expected increases in both these variable expenses and R&D investment, we will manage these costs in line with our revenues to deliver profitable operations in 2017 and double-digit growth in adjusted earnings. That completes our financial report for the full year and fourth quarter of 2016. I'll turn it back over to you, AJ. .

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:.

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. .

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..