Thank you for joining the Cumberland Pharmaceuticals Fourth Quarter 2018 Financial Report and Corporate Update. Please note that this call is being recorded at the company’s request and will be archived on Cumberland’s website for one-week from today. I would like to now introduce Erin Smith, who handles Corporate Relations at Cumberland.

Erin, please go ahead..

Hello, everyone. Today, we issued a press release featuring our fourth quarter 2018 financial results and our company update. That release, including the financial tables that are related to it, is available on our website at www.cumberlandpharma.com. Before we begin today, I’d 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. And because the statements in today’s call 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.

Despite our best efforts, actual results could differ materially from our expectations and information shared on the call today should be considered current as of today only and please remember that the company assumes no duty to update any forward-looking statements, whether as a result of new information or due to future developments.

During today’s call, we’ll be referring to several of the company’s marketed brands, and if you like more information on those brands, including full prescribing and safety information, you’ll find the links to each individual product website at our corporate site at cumberlandpharma.com.

Also, please note that today we’ll provide 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 at 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..

Thank you, Erin. Good afternoon, everyone, and thanks for joining us as we review our financial results while also providing you with an overall update on our company. With me today are Marty Cearnal, our Chief Commercial Officer; and Michael Bonner, Cumberland’s Chief Financial Officer.

We’ll first review highlights on our progress, followed by a more in-depth update on our commercial and our product development activities, and then we’ll review our financial results and finish with some closing remarks before opening the call to any questions you may have. So let’s begin.

I’m pleased to report that in 2018 we demonstrated our commitment and our determination as an organization making significant progress on our goals of expanding our commercial portfolio while also advancing our product pipeline.

We previously stated that our progress was expected to begin impacting our financial performance in the fourth quarter of 2018, and that is exactly what we delivered. We also previously noted that 2019 was shaping up to be a year of solid revenue growth and we still believe that to be the case.

Our expectations are based on the addition of three new revenue drivers. First, the Vibativ acquisition, which we indicated would begin to contribute revenue in late 2018, and it has. Followed by the launch of our new Caldolor formulation in 2019, and we’re set to deliver on that goal as well.

And thirdly, the potential introduction of our new methotrexate product line, which is also advancing as expected. Meanwhile, we continue to progress our robust clinical pipeline, and I’d like to remind you that the commercialization of just one of those development candidates could be a very meaningful catalyst for Cumberland’s growth profile.

We believe these recent accomplishments, combined with our ongoing efforts, can lead to a very successful 2019 for our company. So let’s now review in more detail the progress that we’ve made. During the fourth quarter of 2018, we closed the largest transaction in Cumberland’s history with the acquisition of Vibativ from Theravance Biopharma.

Vibativ is a patented, FDA-approved anti-infective brand, designed to treat serious bacterial infections, including those that are considered difficult to treat and multidrug-resistant. We believe Vibativ is an excellent strategic match for our hospital, acute-care infrastructure and that it can become a flagship product for Cumberland.

Following closing of the acquisition, in mid-November, we immediately began transitioning the brand to Cumberland and we also initiated our shipments of the product.

In the ensuing weeks, we shipped and recorded over $5 million in net sales of Vibativ as we stocked our distribution channels to ensure continued national availability of this potentially life-saving product.

As a result of those strong Vibativ shipments, our net sales surged to $13.5 million in the fourth quarter, which represented double-digit growth from the prior year period. And this growth in sales resulted in adjusted earnings of $1.6 million for the quarter or $0.10 a share.

During the fourth quarter, we also expanded our bank line of credit and used its $20 million availability to fund the Vibativ acquisition. Our total assets grew to $113 million by the end of the year, including $34 million in new assets associated with Vibativ and $36 million in cash and investments.

Meanwhile, we were able to make significant progress on our two key regulatory initiatives. Early last year, we submitted an application to the FDA for the approval of our next-generation Caldolor product. After a series of interactions with the FDA and amendments to our application, we were delighted to learn that the product was approved.

Following this milestone, we’re now preparing for the launch of this patented product, which features an improved package and new formulation. We feel that these important improvements will be welcomed by the market as Caldolor will be easier to administer and the new presentation will also reduce the costs of the product’s preparation.

These improvements give us confidence that Caldolor will continue on its growth trajectory. In addition, we completed and filed an application with the FDA requesting approval for our new methotrexate product line. We’re seeking approval for the use of the products to treat rheumatoid arthritis and psoriasis.

Following that file, the FDA accepted this submission as complete and ready for review, providing us with a target approval decision date of September of this year. Additionally, we continued to advance our clinical programs, which feature several new product candidates in Phase II studies. And in the fourth quarter, the U.S.

National Cancer Institute awarded $2 million in support of a joint research program with Vanderbilt University to advance a new pipeline candidate. So as you’ve now heard that the fourth quarter of 2018 was particularly productive, with a series of very positive developments that we believe position us well for this year.

I’d now like to turn it over to Marty Cearnal, Cumberland’s Chief Commercial Officer, to provide you with an update on our marketing and our sales activities.

Marty?.

Thanks, A. J. There certainly has been a lot of activity at Cumberland during 2018. We welcome the expansion of our commercial product line through the acquisition of Vibativ from Theravance Biopharma.

Vibativ is a patented, FDA-approved anti-infective injectable product is designed to treat certain serious bacterial infections, including hospital-acquired pneumonia and complicated skin infections.

With its unique dual mode of action, Vibativ addresses a range of gram-positive bacterial pathogens, including those that are considered difficult to treat and multidrug-resistant, such as MRSA.

Although the market currently includes the wide use of generic products, like vancomycin and daptomycin, Vibativ has become a go-to choice for follow-on therapy should the infection fail to respond to the use of those generics.

Widespread use of generic anti- infective products has led to an increase in the number of patients experiencing resistance to certain products, resulting in shifts in the clinical standard of care for antibiotic treatments.

We believe that Vibativ is a product uniquely positioned to address such concerns and given our historical success with various hospital- based products, we will be able to support the adoption of this effective and important product.

Since the acquisition, we’ve been working with Theravance to ensure a smooth transition of the product supply and provide medical support to current users of the brand. We also launched our hospital promotion and initiatives to maintain awareness and to help ensure the product is available to the patients who need it.

We’re expanding our infrastructure in order to support Vibativ. We plan to add several sales representatives and medical science liaisons to expand the geographical coverage into key new areas. As A. J. previously mentioned, we recently received FDA approval for our next-generation Caldolor product.

We are very excited that this new product will offer hospitals and medical facilities increased convenience, improved dosing accuracy as well as savings in pharmacy time. We’re delighted to now add this next-generation Caldolor product to our commercial portfolio of FDA- approved brands.

We believe Caldolor is an important product and continue to seek new market segments for this drug. It was initially approved for the treatment of pain and fever in adults and then we secured approval for use in pediatric patients, six months of age and older. Next, we initiated a study to evaluate the product in newborns up to six months of age.

During 2018, we significantly progressed that study, which we believe is the first evaluation of ibuprofen in the youngest of patients. We also had two favorable investigator trials published comparing Caldolor to other pain treatments in adult patients, adding to the growing body of literature that supports this brand.

One study conducted at the Ohio State Wexner Medical Center found that the use of IV ibuprofen compared to IV ketorolac significantly lowered postoperative pain scores and opioid consumption in patients undergoing arthroscopic knee surgeries.

Another clinical trial conducted at Tufts University School of Dental Medicine concluded that preemptive analgesia with Caldolor, our IV ibuprofen, is superior when compared to IV acetaminophen in reducing post-surgical pain and opioid use in patients undergoing surgical removal of impacted wisdom teeth.

Prudent and careful management of pain is among the most important responsibilities of every health care provider. These favorable study results can help guide clinicians on the use of our injectable, non-opioid alternative to reduce or even avoid opioids, mitigating the addiction and abuse risks when those products are prescribed.

You may recall last quarter, we reported that we entered into agreement with Gastro- Entero Logic, or GEL, to acquire the assets associated with Omeclamox-Pak. Omeclamox-Pak is our treatment for Helicobacter pylori infection and related duodenal ulcer disease.

It is an innovative product that combines three well- known and widely prescribed medications; omeprazole, clarithromycin and amoxicillin. The medications are packaged together on convenient daily- dosing cards making it simple to follow the twice-a-day dosing regimen.

Additionally, compared to its competitors, Omeclamox-Pak treatment involves lowest pill burden and the fewest days of therapy, while maintaining an outstanding treatment success rate as recently demonstrated by a new clinical publication.

At the end of the fourth quarter, we closed on the agreement with GEL and had now acquired all assets associated with Omeclamox-Pak. With the closing of this agreement, we no longer provide GEL with royalties on sales and fees for overseeing the products manufactured.

We are also now responsible for maintaining the FDA approval and overseeing the products packaging, trademarks and other assets. That completes today’s update on our key commercial activities, A. J., I’ll turn the call back over to you..

Many thanks, Marty, for that update. Well, in order to be developing new medicines for the future, we’ve established an advanced robust clinical pipeline that includes several product – potential orphan drug candidates. During 2018, we completed study enrollment for Portaban, our portal hypertension clinical program.

We enrolled 30 patients in a randomized double- blind placebo-controlled pilot study to assess the safety of ifetroban in the treatment of portal hypertension in patients with liver disease. An initial review of that data from the study showed ifetroban was indeed well tolerated and there were no unexpected safety findings.

We also continued to advance our Vasculan and Boxaban clinical programs with patient enrollment progressing in each of those Phase II studies during 2018.

You may recall we’re developing Vasculan for patients with systemic sclerosis, the deadliest autoimmune disorder, and Boxaban is in development for the treatment of a severe form of asthma, involving chronic asthma, chronic rhinitis and nasal polyps.

We now are awaiting results from these two remaining Phase II studies before then deciding on the best path for the approval of ifetroban, our first new chemical entity. Additionally, we’re establishing a pipeline of new product candidates at Cumberland Emerging Technologies, or CET, our R&D initiative.

CET's mission is to identify breakthroughs at academic research centers and then advance the resulting product candidates towards the marketplace. And as I mentioned, in October, NIH awarded $2 million in support of a joint research program, involving Cumberland's CET and Vanderbilt University.

CET fosters innovation by partnering with leading academic centers in our part of the country and has expanded that network of institutional collaborators by entering into agreements with Louisiana State University in 2018. And then with the medical college of South Carolina later in the year.

These two new arrangements expanded CETs roster of academic affiliations, which also now include Vanderbilt University, The University of Mississippi School of Pharmacy and the University of Tennessee Research Foundation.

You see these partnerships combine the strengths and capabilities of each organization and by working together, we can identify and develop attractive new biomedical products in the future. That completes our update on the pipeline activities. And next, I’d 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, 2018, net revenues were $13.5 million, a 16% increase compared to $11.6 million for the prior-year period.

Net revenues by product for the fourth quarter included $5.1 million for our newest product, Vibativ, $2.9 million for Ethyol, $2.6 million for Kristalose, $1.5 million for Caldolor and $1 million for Acetadote. For the full year ended December 31, 2018, Cumberland's total net revenues were $40.7 million similar to the prior year.

Net revenues by product for the full year 2018 included $12.1 million for Kristalose, $10.5 million for Ethyol, $5.1 million for Vibativ, $5 million for Caldolor and $4.3 million for Acetadote. Total operating expenses for the three months ended December 31, 2018, were $15.8 million compared to $12.6 million for the prior-year period.

This increase included additional royalties and supply costs associated with the growth in our product sales as well as an increasing investment in our clinical pipeline and an FDA filing fee for our methotrexate approval submission.

For the year ended December 31, 2018, our total operating expenses were $48.1 million compared to $45.2 million in 2017. This annual increase was primarily due to research and development expenses, including the $1.3 million FDA fee associated with our methotrexate submission.

Adjusted earnings for the three months ended December 31, 2018, were $1.6 million or $0.10 per share, a significant increase over the $0.4 million or $0.03 per share in the prior-year period. As of December 31, 2018, we had $113 million in total assets, including over $36 million in cash and marketable securities.

The liabilities totaled $57 million, including $20 million on our credit facility. Total shareholders' equity was just over $55 million at the end of the year. As A. J.

mentioned at the beginning of the call, the acquisition of Vibativ from Theravance was our largest acquisition to date, based on both the product size and the overall consideration for the assets. The financial terms for the Vibativ acquisition included $20 million payment to Theravance upon closing.

This initial payment was funded by the expansion of our revolving credit facility with Pinnacle Bank. We will also be paying Theravance a $5 million additional payment in Q2 2019 and tiered royalties up to 20% of U.S. net product sales. We accounted for the acquisition as a business combination.

A total of $34 million in new assets were added as a result of the acquisition, including $20.5 million in inventory, $11.7 million of intangible assets and $784,000 of goodwill. We recorded a liability of $9 million as the fair value of the contingent consideration resulting from the long-term royalty on product sales.

We do expect the addition of Vibativ will be accretive to the company's earnings as we will largely utilize our existing infrastructure to support the brand. As Marty noted, there will be some modest expansion of our hospital sales division as well as medical science liaison team.

Meanwhile, we continue to believe our shares represent an attractive investment opportunity, and we did continue the company share repurchase program in 2018. During the fourth quarter, we repurchased another 77,000 Cumberland's shares, bringing the total repurchases for the year to 443,041 shares.

In January, our Board of Directors authorized a new $10 million tranche available for repurchase of Cumberland's shares going forward using our excess cash generated from operations. That completes our financial report for both the full year and fourth quarter of 2018. I’ll turn it back over to you. A. J..

Thank you, Michael. Well, as you heard today, we're enjoying significant momentum based on a series of milestone achievements. And as a result, 2019 is shaping up to be one of solid revenue growth.

As I've mentioned earlier, we're very excited about the potential of developments we've reported on today, led by the Vibativ acquisition and including the planned introduction of the next-generation Caldolor product and the potential approval for our new methotrexate product line. Furthermore, we intend to build and advance our clinical pipeline.

If just one of those products in development receives approval, it could be a significant catalyst for our company. And finally, I'd just like to acknowledge and thank our team for their dedicated efforts and hard work in 2018.

You see the interest of this organization, its management and our shareholders remain closely aligned, given the significant insider ownership in the company. We'll continue to focus on sustained growth and profitability through new product introductions, marketing and product enhancements and the efficient use of our financial resources.

And we're confident we've put the key pieces in place to help us deliver on our goals to improve patient care to 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 and we will now open the call for questions. [Operator Instructions] If you would like to listen to a replay of today's conference, please dial 855-859-2056 using the access code 4258737. 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 all disconnect..

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Okay. Well, I just want to thank everyone for joining the call today. And as I've mentioned in the past, we do understand that many of you prefer a private discussion with management. And if so, please just reach out to Erin Smith here if you'd like to schedule such a call.

We do appreciate your time and interest in Cumberland, and we look forward to providing you with another update following the end of the first quarter..

Thank you. Ladies and gentlemen, that concludes our conference for today. If you would like to listen to a replay of today’s conference, 855-859-2056 using the access code 4259498. 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..