Erin Smith - Corporate Relations A. J. Kazimi - Founder, Chairman, CEO and President Martin Cearnal - Chief Commercial Officer, EVP and Director Michael Bonner - CFO and Senior Director of Finance & Accounting.

Andrew D'Silva - B. Riley FBR.

Thank you for joining the Cumberland Pharmaceuticals Fourth Quarter 2017 Financial Report and Corporate Update. Please be advised that this earnings call is being recorded at the company's request and will be archived in Cumberland's website for one week from today.

I would now like to introduce Erin Smith, who handles corporate relations at Cumberland. Erin, please go ahead..

Good afternoon, everyone. Before we begin our report today, I'd like to point out that earlier, we issued a press release containing our financial results for the fourth quarter 2017 and the full year 2017. That release, including the financial tables, is available on our website at www.cumberlandpharma.com.

I'd also like to share the following safe harbor language before we get started today. This call may contain forward-looking statements within the meaning of the Private Securities Reform Act of 1995.

Because they reflect the company's current views and expectations concerning future events, these forward-looking statements 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 updates filed with the SEC.

Any forward-looking statements made during today's call are qualified by those risk factors. Our future results could differ materially from the views expressed in today's call, so we don't assume any obligation to publicly update any forward-looking statements, whether as a result of new information or due to future developments.

Also, please note that today, we'll provide some non-GAAP financial measures with respect to our performance. An explanation and reconciliation to GAAP measures can be found in our earnings release and the regulated financial tables. I will now go ahead and turn the call over to our Chief Executive Officer, A.J.

Kazimi, to begin our discussion of the company's performance and plans..

Thanks, Erin. Good afternoon, everyone, and thank you for joining us as we review our fourth quarter, as well as our full year 2017 results. We'll also discuss the recent developments here and provide an update on our key initiatives and share our outlook for 2018.

Joining me on the call today are Marty Cearnal, Cumberland's Chief Commercial Officer; and Michael Bonner, our Chief Financial Officer. Today, we start with an overview of our progress in the fourth quarter and then follow with the discussion of our commercial and product development activities.

We'll then review our financial results and finish with our closing remarks before opening the call to any questions you may have. So let's begin. Those familiar with Cumberland know that our goal is to build a company that delivers sustainable growth and profitability.

And to that end, we've been adding new brands, we've been increasing the number of sales representatives supporting our products, launching new marketing strategies, expanding product labeling, protecting our intellectual property and advancing our clinical pipeline.

So as a result, we're a very different company today than we were just a few years ago. Our product portfolio has doubled in size. Our reach has substantially increased. And our pipeline has expanded to now address several market opportunities totaling hundreds of millions of dollars.

As noted in today's announcement, I'm very pleased to report that as a result of these initiatives, we now have the most diversified revenue stream and the broadest clinical pipeline in Cumberland's history. We've also made significant progress on our growth objectives, posting Q4 2017 net revenue of $11.6 million or 28% year-over-year growth.

Adjusted earnings for the quarter were $0.4 million or $0.03 a share, a turnaround from the $0.1 million loss incurred during the prior year period.

Our balance sheet continued to remain strong with over $93 million in total assets including $50 million in cash and investments at the end of the year, and total liabilities were approximately $29 million, resulting in $64 million of shareholder equity.

An important contribution to our performance in 2017 came from our new oncology products, Ethyol and Totect. Both brands are designed to help patients tolerate the treatment for their cancers and we've provided them and supported patients at cancer centers and children's hospitals across the country.

Also during the year, we signed and implemented a new co-promotion partnership with Poly Pharmaceuticals. They're featuring our Kristalose brand to medical specialties that we don't cover.

And Poly's sales organization is slightly larger than our field sales force, and is now fully trained on Kristalose and began introducing the brand to thousands of new medical practitioners during 2017.

While we've been working hard to continue building a portfolio of differentiated pharmaceutical brands, we've also been seeking ways to maximize the potential of our existing products. In early 2017, we successfully defended a key Acetadote patent through a federal court ruling that upheld the validity of the patent through August 2025.

And we also noted several publications during the year featuring important new data associated with our Caldolor and Vaprisol brands. Our clinical programs also continued to advance in 2017. Following FDA clearance early in the year, we initiated our second Phase II Boxaban study in centers across the country.

And patient enrollment in our Phase II Vasculan and Portaban studies also progressed during the year. There were changes in our board of directors in 2017. Tom Lawrence, our longest-serving Independent and Lead Director, passed away last year.

Joey Jacobs, the Chairman and Chief Executive Officer of Acadia Healthcare, another publicly traded health care company, assumed responsibility as our Lead Independent Director going forward. We also added a new board member in Ken Krogulski, President and Chief Executive Officer of Berkshire Asset Management.

Ken brings nearly 40 years of experience in security analysis and portfolio management at Berkshire, where he now manages over $2 billion in invested funds. So with that overview, I'd now like to turn it over to Marty Cearnal, Cumberland's Chief Commercial Officer to provide you with a briefing on our marketing and sales activities.

Marty?.

Thanks, A.J. As A.J. has mentioned, there's been a lot of progress here at Cumberland during 2017. Our first oncology brand, Ethyol, delivered a significant contribution to our business.

Ethyol is our patented, branded amifostine product indicated to reduce xerostomia or dry mouth, a side effect in patients undergoing postoperative radiation treatment for head and neck cancer. It also reduces the cumulative renal toxicity associated with repeated administration of Cisplatin in patients with advanced ovarian cancer.

We launched the product late in 2016 and have been encouraged by its performance and significant contribution to our growth in 2017. While there are two generic amifostines approved in the U.S., our brand is the only product currently available.

We've been working to create brand awareness and loyalty in order to build a sustainable, long-term branded business. We aim to establish Ethyol as critical support for many cancer patients undergoing select radiation or chemotherapy treatments. We continued to expand our commercial product line in 2017 with the acquisition of the exclusive U.S.

rights to Totect, another oncology support drug. Totect is an FDA-approved emergency treatment indicated to address the toxic effects of certain chemotherapeutic agents. Totect is the only antidote clinically proven and approved specifically for anthracycline extravasation.

This occurs when an injected anthracycline anticancer agent escapes from the blood vessels and circulates in its surrounding tissues in the body. When this happens, it can cause severe damage to tissues and other serious complications.

Totect provides rapid response to prevent the devastating effects of such tissue damage, virtually eliminating the need for surgery and allowing the continuation of scheduled chemotherapy in most patients. There are three other dexrazoxane products approved in the U.S. all for an indication that is different from Totect's.

As previously reported, we initiated shipments of Totect during a national shortage of dexrazoxane, which resulted in strong initial demand for our product. It was particularly rewarding to provide emergency shipments of Totect to children's hospitals across the country to enable pediatric patients to continue their essential cancer treatment.

During the fourth quarter, limited supplies of one of the competitive dexrazoxane products began reappearing on the market. Totect's strong performance continued during the quarter, and as with Ethyol, our goal is to build a sustainable long-term branded business. As A.J.

mentioned, we fully implemented our co-promotion partnership with Poly Pharmaceuticals for Kristalose during 2017. We're determined to maximize the potential of our products and believe teaming with select partners such as Poly can augment and expand the support for our brands.

Results have been encouraging as the Poly sales force is reaching thousands of new physicians and medical specialties that we don't cover. We've noted growing numbers of new monthly prescriptions from Poly's efforts and believe it can provide a meaningful contribution to Kristalose sales during the three year co-promotion agreement term.

Meanwhile, we were pleased that both Caldolor and Vaprisol were the subject of favorable clinical publications in 2017. A study featuring Caldolor demonstrated its ability to significantly reduce fever in hospitalized patients. That pivotal data contributed to the FDA's approval for the brand in pediatric patients six months and older.

Another new study provided evidence that Caldolor can significantly improve postoperative pain control while also significantly reducing opioid use in patients undergoing surgery. Vaprisol is highlighted in a publication as a well-tolerated solution for hyponatremia.

This potentially serious condition continues to be the leading type of electrolyte imbalance seen in hospitalized patients. You may be aware that U.S. drug shortages have resulted from the impact of the hurricanes on the pharmaceutical manufacturing plants located in Puerto Rico. Unfortunately, those storms impacted supplies of our Vaprisol brand.

Our inventory has been limited, reducing sales in the fourth quarter. We are working to remedy this situation and we'll provide an update when the manufacturing for this product resumes. Finally, I'd like to point out that our brands face competition from other branded products, generics and alternative medical treatments.

Our task is to position each brand to feature its competitive advantages, implement well-thought-out marketing plans and provide focused sales and other tactical support. We start each year with a fresh look at each brand's position and strategy, building comprehensive marketing plans.

For 2018, we'll continue many effective programs such as the select telemarketing, couponing and expert medical presentations. During this year, we'll also introduce several new marketing campaigns such as targeted brand advertising and special hospital system presentations to increase awareness.

While we'll continue to attend the series of key national medical conferences, we will also increase our presence in regional medical meetings. That completes today's updates on our key commercial activities. A.J., I'll turn the call back to you..

Thanks for that update, Marty. There are hundreds of companies developing new medicines with no marketed brands and we're fortunate to have an established sales and marketing infrastructure, which we consider to be a very valuable asset.

And we enjoy an expanding commercial line, while we also await the arrival of the breakthrough products currently in development. During 2017, we worked to progress that clinical pipeline and then we now have four product candidates in late-stage development.

All four are derived from ifetroban, Cumberland's first new chemical entity or NCE, which was initially discovered in research by a large pharma company, and we now have the worldwide rights to that compound, ifetroban. It's a potent antagonist of a thromboxane receptor that inhibits smooth muscle contraction, platelet aggregation and inflammation.

Ifetroban's safety is well established through a robust database involving 1,300 subjects in 26 clinical studies. We are pursuing four patient conditions with this molecule that represent unmet medical needs and also include candidates for orphan drug designation.

We believe this pipeline is compelling and we're studying collectively these products in development, address markets with hundreds of millions of dollars in revenue potential.

Early in 2017, we reported on the FDA clearance to continue our Boxaban clinical program and we're developing Boxaban for the treatment of aspirin-exacerbated respiratory disease or AERD, a condition involving chronic asthma, chronic rhinitis and nasal polyps that are worsened by aspirin.

AERD is characterized by sharp increases in inflammatory mediators and platelet activity within the respiratory system. Following FDA's clearance, we then initiated our second Phase II study to evaluate the efficacy of Boxaban in over 70 patients with symptomatic AERD.

Enrollment in that multicenter, placebo-controlled study is now well underway at a number of allergy and asthma centers across the United States. As I mentioned, we also have Phase II clinical studies progressing for our Vasculan and Portaban development programs.

As you may recall, we're developing Vasculan for patients with systemic sclerosis, the deadliest autoimmune disorder which involves a thickening of the skin and internal organs. We are building here on compelling preclinical data from researchers at Vanderbilt University who demonstrated the impact of ifetroban on fibrosis.

The FDA cleared our IND to evaluate the safety and efficacy of Vasculan in patients with this condition, and as a result, we initiated a Phase II multicenter study in patient enrollment and this study progressed in 2017 at several scleroderma Centers of Excellence across the United States.

The patient accruals in that study was slower than expected, and therefore, we have begun working to add new centers in order to speed enrollment in that trial. Portaban is in development for the treatment of portal hypertension associated with liver disease.

Preclinical studies have shown ifetroban can reduce portal pressure inflammation and associated fibrosis in multiple models of liver injury. Enrollment in this study was well underway at several U.S. hepatology centers during 2017 and we're pleased with the progress in that trial.

We also continued to advance our Hepatoren product candidate, which we're developing for patients with hepatorenal syndrome or HRS. These patients suffer from progressive kidney and liver failure leading to a rather high mortality rate.

We have previously completed an initial Phase II study to evaluate the safety and pharmacokinetics of Hepatoren for this unmet medical need, and top line results indicated that Hepatoren was well-tolerated overall in HRS patients with no safety concerns noted.

We filed the results from this study with the FDA and in 2017, worked to design a follow-up efficacy study. And lastly, we previously reported on our agreement with the Nordic Group to acquire exclusive U.S. rights to their injectable methotrexate product line used in the treatment of arthritis.

Injectable methotrexate has been shown to result in increased efficacy, greater continuation rates and less discomfort for these patients. While other presentations of methotrexate are available, we are registering a unique and branded product designed to increase safety, comfort, ease-of-use and dosing accuracy.

While these methotrexate products have been approved for use across Europe, we'll need to register them with the FDA for approval for sale here in the United States. During 2017, we had - we held a successful meeting with the FDA to discuss the registration pathway for these injectable methotrexate products.

And as a result, we are now gathering the relevant information and preparing the submission for that approval. The development of new pharmaceutical products can be a long, expensive and risky process, and there's no assurance we'll secure FDA approval for these various pipeline candidates.

Our strategy is to focus on later-stage development candidates that address unmet medical needs or poorly met medical needs where the regulatory requirements may be lower and the speed of FDA review and approval may be faster.

Remember, our team has successfully developed and registered both our Acetadote and Caldolor brands, and they are now focused on the ifetroban programs and methotrexate opportunity that I outlined. Well that completes our update on Cumberland's pipeline activities.

I'd now like to turn to our Chief Financial Officer, Michael Bonner, for the financial review.

Michael?.

Thank you, A.J. For the three months ended December 31, 2017, net revenues were $11.6 million, a 28% increase compared to $9.1 million for the prior year period. These results represent our sixth consecutive quarter of double-digit revenue growth.

Net revenues by product for the fourth quarter were led by $3.4 million for Kristalose, $2.5 million for Ethyol and $2.2 million for Acetadote. Sales for Caldolor were $1.4 million, Totect, $1.1 million, $0.6 million for Omeclamox, and $0.2 million for Vaprisol.

As Marty noted, our newest oncology support brands provided a significant contribution, while sales of Vaprisol were limited by supply issues. For the full year ended December 31, 2017, Cumberland's total net revenues were $41.2 million, an increase of 25% over the $33 million during the prior year.

Net revenues by product in 2017 were $11.5 million for Kristalose, $10.8 million for Ethyol and $6.6 million for Acetadote. Sales for Caldolor were $4.2 million. Totect sales were $4 million. Sales for Omeclamox were $1.8 million and $1.6 million for Vaprisol.

Total operating expenses for the three months ended December 31, 2017 were $12.6 million compared to $10 million for the prior year period. This increase included additional royalties and supply costs associated with the growth in product sales, as well as an increasing investment in our clinical pipeline.

For the year ended December 31, 2017, our total operating expenses were $45.2 million compared to $34.5 million for 2016. Again, royalty and cost of goods associated with our revenue growth were the largest contributors to this increase.

Adjusted earnings for the three months ended December 31, 2017 were $0.4 million or $0.03 per share compared to a loss of $0.1 million or negative $0.01 per share during the prior year period. As of December 31, 2017, we had $93 million in total assets including over $50 million in cash and marketable securities.

Liabilities totaled $29 million, including $9.8 million on our credit facility at the end of the quarter. Total shareholders' equity was $63.9 million at the end of the period. Meanwhile, we did continue the company's share repurchase program.

During the fourth quarter, we repurchased another 108,661 Cumberland shares, bringing the 2017 total repurchases to 547,376 shares. During the fourth quarter, we recorded a non-cash expense of $380,000 due to the contribution of Cumberland's shares to our newly formed foundation.

That's in addition to the $4.2 million in non-cash expense, resulting from an increase in reserves against our deferred tax assets earlier in the year. Overall, we were very pleased with the 25% annual revenue growth and positive adjusted earnings for the year.

We do expect to post continued growth for the year 2018 and are confident we will make meaningful progress on our growth and profitability objectives. That completes our financial report for both the full year and fourth quarter of 2017. I'll turn it back over to you, A.J..

Thanks, Michael. A couple of years ago, we heightened our business development efforts with the goal of expanding our product line and launching one new brand a year. We followed with the Clinigen strategic alliance, and introduction of Ethyol in 2016 and Totect in 2017.

Here, in 2018, we'll work to register and introduce a next-generation Caldolor product and also seek approval for our RediTrex methotrexate product line. We now have two co-promotion partnerships in place with Piramal Critical Care to augment our hospital sales activities and with Poly Pharmaceuticals in support of Kristalose.

During 2018, we plan to take a fresh look at our sales force targeting to ensure we're focused on the most important prescribers of our brands. We'll also continue to do co-promotion arrangements to further augment our personal sales coverage.

We believe we can add significant value to successful clinical development and FDA registration of our new product candidates, and we feel that our pipeline is perhaps one of the most underappreciated aspects of our company. We intend to continue to fund the required clinical studies, while carefully managing that investment.

You may have noticed that we filed a shelf registration on Form S3 with the SEC. That registration has now cleared and is active. It includes an at-the-market or ATM offering, which may select - which we may select to be utilized in order to expand our institutional ownership and liquidity in our shares.

We entered 2018 with strong momentum and we will work to continue that growth, improve our bottom line and progress our clinical programs. Our goal remains the same, to deliver sustained revenue growth and profitability, and we're confident we're putting in place the key pieces that will enable us to do just that over the coming years.

Finally, I'd like to acknowledge and thank our team for their efforts this past year and for doing their part in advancing our mission of improving patient care through the delivery of high-quality pharmaceutical products. So with that review and update, now let's open the call to any questions you may have. Operator, please proceed..

Thank you, sir. Ladies and gentlemen, that concludes the company's presentation. We will now open the call for questions. [Operator Instructions] Our first question comes from Andrew D'Silva with B. Riley FBR. Your line is now open..

Good afternoon. Thanks for taking my questions. I'm still getting up to speed with your company. So could you please help me understand how to think about R&D spending? You have a fairly large pipeline, but it seems as though your R&D spend is still very low.

How should we think about that spending line going forward?.

Well, we are committed to investing in that pipeline. Unfortunately, the patient conditions we're addressing are orphan in nature, and the studies we've been designing have been modest in size. Our plan is to fund out that R&D in a growing way as our revenues grow.

And fortunately, as we reported, we've been enjoying revenue growth and we are forecasting additional growth this year..

Okay. Thank you. And staying with your pipeline candidates, I believe you said you licensed ifetroban from Vanderbilt.

Do you have global rights for all indications? Or is it selected indications? And if you do have that, are you looking to out-license the candidates internationally and perhaps look at maybe other indications domestically that you could either utilize the technology in or license it in?.

Okay. So first of all, yes, we do own the worldwide rights to ifetroban and all its potential uses. Our strategy has been to focus on the U.S. where we have our own commercial infrastructure and to partner with others in various parts of the world who have established registration and commercial capabilities.

So what we will be doing is developing ifetroban for the various indications in the U.S. to potentially launch ourselves. At the same time, once we have additional data, seek - starting to seek international partners to take the product to patients in their countries..

Okay. Thank you. And last question for me as it relates to Totect.

With the essential high revenue that you recognized in the third quarter primarily due to shipping shortages, and then is the fourth quarter revenue that you recognized for the product essentially the run rate we should expect to build off of going forward? Or is there any sort of lumpiness you can point us to? Any clarity there would be useful..

You're absolutely right that we were extremely fortunate to get the product launch at a time when there was a nationwide shortage of dexrazoxane, and that allowed us to get a broad base of initial distribution.

Our expectation has been that over time, Totect will command about a third of this market, recognizing that there are two other dexrazoxane products, while they were in shortage at the time of launch, will eventually come back into the market. So I think the fourth quarter is something of an indicator.

But I guess, overall, what we've said is that over the next two years or so, we expect to attain about a consistent one third market share in this marketplace..

Great. Thank you very much. And good luck going forward this year..

Okay. Thank you..

And I'm showing no further questions. I'd like to turn the call back over to management for any closing remarks..

Okay. Well, we recognize that some of you prefer a private conversation with management and we're certainly prepared to do that. Please, if you like to hold such a call, reach out to Erin Smith here to schedule that.

And meanwhile, we do appreciate your time and interest in Cumberland, and we look forward to providing another update after the end of the first quarter..

Ladies and gentlemen, that concludes our conference for today. If you would like to listen to the replay of today's conference, please dial (855) 859-2056 using the access code 259-9485. Alternatively, a replay of the webcast will be available in the company's website. I'd like to thank you for your participation. You may now disconnect..