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

Thank you for joining the Cumberland Pharmaceuticals Third Quarter 2017 Financial Results and Corporate Update. Please be advised that this conference 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. Erin, please go ahead..

Good afternoon, everyone. Before we begin today, I would like to note that earlier, the company issued a press release containing our financial results for the third quarter ended September 30, 2017. That release, including our update and the financial tables is available on our 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 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 we file 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 and 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 and an 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..

Thanks, Erin. Good afternoon, everyone, and thanks to all of you for joining us as we provide an update on our recent activities and review our third quarter results. We are making good progress in 2017, and we appreciate your participation in today’s call as we share what’s happening here at Cumberland.

Joining me are Marty Cearnal, our Chief Commercial Officer; and Michael Bonner, Cumberland’s Chief Financial Officer. Today, we’ll start with an overview of our progress in the third quarter and follow with a discussion of our commercial and our product development activities.

We’ll then review our financial results and finish with our closing remarks before opening the call to any questions. So let’s begin. Over the past two years, we’ve dramatically expanded our product portfolio through a series of successful business development initiatives.

As a result, we now market seven FDA approved brands, and we have a robust pipeline of new product candidates in development. This quarter’s strong year-over-year revenue growth included significant contributions for our most recent additions to the portfolio. In addition, we continue to update the messaging and marketing strategies for our brands.

We’ve also added and trained nearly 50 additional sales personnel through our Piramal and Poly Pharma co-promotion partnerships. And we expect their contributions to grow, as their experience with selling our products increases and they can identify and repeatedly deliver our brand messages to medical professionals that Cumberland is not covering.

By design, we are a very different company today than we were just a few years ago. Our product portfolio has doubled. Our reach has substantially increased. Our pipeline now addresses several market opportunities in the hundreds of millions of dollars.

This product-diversified strategy has driven our double-digit top line growth over the last year and our momentum is strong. Our goal remains the same, to deliver sustained revenue growth and profitability, and we’re confident we are putting the key pieces in place that will help us to do just that in the coming years.

Let’s review the key highlights of our third quarter starting with our strong top line performance. I’m pleased to report that net revenues for the third quarter were $11.2 million, a 27% increase over the prior year period and a 29% increase over the second quarter.

An important contributor to that performance was the launch of our newest brand, Totect, in the quarter as we began shipments and also began our promotional support for the product. Totect is our branded dexrazoxane and seventh FDA approved commercial product.

We launched Totect during a national shortage of dexrazoxane, resulting in strong initial demand, and it’s our second oncology support brand to emerge from the strategic alliance with the Clinigen Group.

Also during the quarter, we completed the implementation of our new co-promotion partnership with Poly Pharmaceuticals, following a multi-year agreement that we signed earlier in 2017. Poly is a privately-held U.S. specialty pharma company and they are featuring our Kristalose brand to an expanded number of physicians.

Poly sales organization is now fully trained on the product and is bringing Kristalose to position audiences that we just don’t cover, promoting the brand to thousands of new medical providers. Our balance sheet continued to remain strong during the third quarter with just over $90 million in total assets and $50 million in cash and investments.

At the end of September, total liabilities were approximately $25 million, resulting in $65.1 million of total shareholders’ equity. So with that overview, I’ll now turn it over to Marty Cearnal, Cumberland’s Chief Commercial Officer to provide you with the briefing on our marketing and sales activities.

Marty?.

Thanks, A.J. As A.J. mentioned, there has been a lot of progress here at Cumberland during the third quarter. We’ve been busy with a new product launch, convened the National Sales Meeting and fully implemented our new co-promotional arrangement.

We featured our newest commercial product, Totect, our branded dexrazoxane at the National Sales Meeting in September. Totect is an FDA approved emergency oncology treatment indicated to resolve the toxic effects of extravasation or drug leakage that is associated with certain chemotherapy agents.

Totect is the only antidote clinically proven and approved specifically for anthracycline extravasation. This occurs when an injected medication escapes from the blood vessels and circulates into surrounding tissues in the body. When this happens with an anthracycline anticancer agent, it causes severe damage to tissues and serious complications.

Totect provide 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.

It’s important to note that we initiated shipments of Totect during a national shortage of dexrazoxane, which resulted in strong initial demand for the product. It was particularly rewarding to provide emergency shipments of Totect to oncology centers across the country and enable patients to continue their essential cancer treatments.

In preparation for the Totect launch, we completed the training of our hospital sales and our medical organizations, stocked the product at oncology wholesalers and introduced a new website. Meanwhile, we fully implemented our co-promotion partnership with Poly Pharmaceuticals for Kristalose.

Cumberland is determined to maximize the potential of our products, and we believe teaming with select partners such as Poly can augment and expand support for our brands. Early results are encouraging, as the Poly sales force is reaching thousands of new physicians in medical specialties that we don’t cover.

Additionally, during the third quarter, Ethyol delivered a significant contribution to our business. Ethyol is our patented, branded amifostine product indicated to reduce xerostomia or dry month, a side effect in patients undergoing post-operative radiation treatment for head and neck cancer.

It also reduces accumulative renal toxicity associated with the repeated administration of Cisplatin in patients with advanced ovarian cancer. We launched the product late in 2016, and expect that it may become our largest contributor over time. That completes today’s update on our commercial activities, A.J. I’ll turn it back over to you..

Thank you, Marty. During the third quarter, we also progressed our pipeline. We have four product candidates currently in late-stage development, and all four are derived from ifetroban, Cumberland’s first new chemical entity or NCE.

As a reminder, ifetroban was initially discovered and researched by a large pharma company, and Cumberland has acquired the worldwide rights to this program. The safety and activity of ifetroban is well-established in studies including over 1,000 patients.

We’re pursuing four patient conditions that represent unmet medical needs and include candidates for orphan drug designation. Collectively, these development programs address markets with hundreds of millions of dollars in revenue potential. Earlier in the year, we reported on the FDA clearance to continue our Boxaban clinical program.

We are developing Boxaban for the treatment of aspirin-exacerbated respiratory disease or AERD, a disease 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 clearance, we initiated a follow-on Phase II study to evaluate the efficacy of Boxaban in over 70 patients with symptomatic AERD. Enrollment in this multicenter, placebo-controlled study is now well underway at a growing number of allergy and asthma centers across the United States.

We also have Phase II clinical studies progressing for our Vasculan and our Portaban ifetroban programs. As you may recall, we are developing Vasculan for patients with systemic sclerosis, the deadliest autoimmune disorder, which involves a thickening of the skin and internal organs.

The FDA cleared our IND to evaluate the safety and efficacy of Vasculan in patients with systemic sclerosis. And as a result, we initiated a Phase II multicenter study and patient enrollment in that trial is ongoing at several scleroderma Centers of Excellence across the United States.

Portaban is in development for the treatment of portal hypertension, which is associated with liver disease. Preclinical studies have shown, ifetroban can reduce portal pressure, inflammation and fibrosis in multiple models of liver injury. Enrollment in this Phase II study is also underway at several U.S. hepatology centers.

And we’ve continued to advance our Hepatoren product candidate, we’re developing this one for patients with hepatorenal syndrome or HRS. These patients suffer from progressive kidney failure, leading to a very high mortality rate.

And we did complete an initial Phase II study to evaluate the safety and pharmacokinetics of Hepatoren for this unmet medical need. And the top line results indicated that it was well-tolerated in these patients with no safety concerns.

We filed the results from the study with the FDA, and we’ve now been working along with an international expert in this field to develop the design for a follow-up efficacy study. And lastly, we previously reported on our agreement with the Nordic Group, where we acquired the exclusive U.S.

rights to their injectable methotrexate product line, which is used in the treatment of arthritis. Injectable methotrexate has been shown to result in increased efficacy, greater continuation rates and less discomfort for patients with these conditions.

While the Nordic methotrexate products have been approved for use in Europe, we will be seeking FDA approval for this product line here in United States. During the quarter, we held a meeting with the FDA to discuss the registration pathway for our injectable methotrexate products.

And as a result, we are now gathering the relevant information and preparing that submission for approval. So that completes our update on Cumberland’s pipeline activities. And 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 September 30, 2017, net revenues were $11.2 million, a 27% increase over $8.8 million for the prior year period. We enjoyed significant contributions from three of our brands during the quarter, as Totect delivered $2.9 million of revenue, followed by $2.8 million for Kristalose and $2.6 million for Ethyol.

Net revenues in the third quarter for our other brands totaled $2.8 million, with Acetadote delivering $1.3 million, $0.9 million for Caldolor, $0.4 million for Vaprisol and approximately $0.2 million for Omeclamox-Pak. I’d like to point that domestic Caldolor revenue continued its growth trend during the third quarter.

However, total Caldolor revenues were down from the prior year due to less international shipments resulting from manufacturing delays. We have now remedied that issue by bringing a new supplier on line for the product.

Total net revenues for the nine months ended September 30, 2017 were $29.5 million, a 23% increase compared to $23.9 million for the prior year period. As always, we continue to believe that our performance is best judged on an annual basis. Furthermore, we still expect to deliver double-digit revenue growth for the full-year 2017.

Total operating expenses for the three months ended September 30, 2017 were $12 million, compared to $8.7 million for the prior year period. Total operating expenses for the first nine months of 2017 were $32.7 million, compared to $24.5 million for 2016.

When compared to the prior year periods, our research and development spending increased by $0.3 million for the third quarter of 2017 and $0.9 million for the first nine months of 2017, as we invest in our clinical programs. The overall expense increases were also impacted by the royalties and cost of goods associated with our growth in sales.

Adjusted earnings for the third quarter were $0.1 million, or $0.01 per share, compared to $1 million, or $0.06 per share the prior year period. During the quarter, our balance sheet included total assets of $90 million, including $50 million in cash and marketable securities.

Liabilities at the end of the quarter totaled $25.4 million, including $8 million on our credit facility. The balance on the line of credit represents the funding of acquisitions, including the impact of the royalty payments associated with the acquisition of the U.S. rights to Ethyol and Totect.

Total shareholders’ equity was $65.1 million at the end of the period. Meanwhile, we also continue to execute on our share repurchase initiatives. During the third quarter, we repurchased an additional 155,859 Cumberland shares, bringing the total shares repurchased this year to 438,715.

That completes our financial report for the third quarter of 2017..

Thanks, Michael. Well, we’re confident that our strategy of building a diversified product portfolio is well suited to deliver sustained growth and profitability in the coming years. We’ll continue to fine-tune our marketing efforts and we’ll utilize our recently enhanced sales coverage to drive revenue growth.

We’re also encouraged by the initial performance of both Ethyol and Totect. And furthermore, our methotrexate product line represents another growth catalyst opportunity for the company. In fact, we believe our clinical pipeline is rich with opportunity and perhaps not yet being given the recognition or value it deserves.

Finally, as always, we’ll continue to manage our operations with financial discipline, and we remain in a strong financial position with growing revenues, high margins, positive adjusted earnings and a favorable balance sheet.

I’d like to acknowledge and thank our team for their efforts this year and for doing their part in advancing our mission of improving patient care to 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, can you 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].

Okay. Well, thanks, everyone, for joining the call today. We do understand that many of you prefer a private discussion with management. And if so, please reach out to Erin Smith here if you like to hold such a call.

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

Ladies and gentlemen, that concludes the conference for today. And I would like to – if you would like to listen to the replay of today’s conference, please dial 855-859-2056 using the access code of 5299837. Alternatively, the replay will be broadcast – available on the company’s website. I would like to thank you all for your participation.

You may all now disconnect..

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