Earnings Labs

Cumberland Pharmaceuticals Inc. (CPIX)

Q4 2019 Earnings Call· Wed, Mar 18, 2020

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Transcript

Operator

Operator

Thank you for joining the Cumberland Pharmaceuticals’ Fourth Quarter 2019 Financial Report and Company Update. Please note that this conference call is being recorded at the company’s request and will be archived on Cumberland’s website for 1 week from today’s date. Now, I would like to introduce Erin Gull, who is responsible for Corporate Relations at Cumberland. Erin, please go ahead.

Erin Gull

Management

Good afternoon. Today, we issued a press release featuring our fourth quarter and full year 2019 financial results and company update. You can find that release including all the related financial tables on our website at www.cumberlandpharma.com. Additionally, our call today may contain forward-looking statements within the meaning of the Private Securities Reform Act of 1995. Because of the statements in today’s call reflects the company’s current views and expectations concerning future events. Any forward-looking statements may involve risks and uncertainties. So please note that many factors could affect the company’s future results, including natural disasters, public health epidemics and other events beyond our control 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. And despite our best efforts, actual results could differ materially from our expectations. And the information shared on the call today should be considered current as of today only. Please remember that the company does not assume any responsibility to update such forward-looking statements whether as a result of new information or due to future developments. And also during today’s call, we will be referring to several of our marketed brands. If you like to see full prescribing and safety information for each brand that can be found through the links to the individual product websites on our corporate site cumberlandpharma.com. Also we will provide some non-GAAP financial measures with respect to our performance today. An explanation and reconciliation to GAAP measures can be found in our earnings release and financial tables. With us on today’s call are A. J. Kazimi, Cumberland’s Chief Executive Officer; Marty Cearnal, our Chief Commercial Officer; and Michael Bonner, our Chief Financial Officer. And I will now turn the call over to A. J. to begin our discussion of the company’s performance and our company updates.

A. J. Kazimi

Management

Well, good afternoon everyone and thanks for joining us. We appreciate your participation and as Erin noted, we will provide an overall company update and review of our fourth quarter as well as our full year financial results. And I would just like to start by noting the serious coronavirus outbreak spreading across our country impacting the economy and the financial markets. Our thoughts certainly go out to those suffering from this development and especially the patients whose illnesses have led to a life threatening condition. Please be assured that here at Cumberland, we are taking appropriate action to protect our employees, secure our supply chain and continue to support the patients who can benefit from our medicines. During today’s call, we will first cover highlights on our progress, followed by a more in-depth update on our commercial and our product development activities and then we will report our financial results before finishing with some closing remarks and opening the call to any questions. While I am pleased to report, that 2019 was a productive and successful year for Cumberland Pharmaceuticals. As you will hear today, we made good progress in advancing our major initiatives and accomplishing many key objectives. We set out to deliver double-digit revenue growth in 2019 and we did just that. Moreover, we announced the strategic review of our brands, our capabilities and our partners at the beginning of last year and then we moved quickly to conduct those efforts and implement our conclusions. We also expanded our sales organization and we refocused their promotional efforts. During 2019, we advanced our clinical programs, obtained two key FDA approvals and entered into several new international agreements for our products. So you just heard we embarked on a long and complex set of tasks last year, but I…

Marty Cearnal

Management

Thanks, A. J. As you heard, there has been an abundance of activity here at Cumberland. We made meaningful progress in several key areas of our long-term growth strategy. We continue to develop and implement programs for our marketed products and we also completed to successful transition of Vibativ to Cumberland. We finalized plans for the launch of our next generation Caldolor product and also began preparations for the upcoming launch of our RediTrex product line. We were also pleased that our newest drug, Vibativ or telavancin injection was the subject of two favorable clinical publications during 2019 adding to the growing library of literature supporting that brand. As a reminder, Vibativ is a patented FDA-approved anti-infected design to treat serious bacterial infections, including those that are considered difficult to treat and multi-drug resistant. It is a lifesaving product for certain difficult-to-treat infections and we believe it’s an excellent match for our existing infrastructure and can become a flagship product for Cumberland. Study analysis reported in infection diseases and therapy showed numerically superior cure rates for Vibativ when compared to vancomycin within a set of patients who had hospital acquired pneumonia caused by bacteria with low susceptibility to vancomycin. Another manuscript published in drugs and real world outcomes detailed the positive clinical outcomes that resulted from treating multiple infection types with Vibativ, including complicated skin and skin structure infections, bone and joint infections, bacteremia and endocarditis and also lower respiratory tract infections. While we were transitioning Vibativ to Cumberland this year, we also redesigned our hospital territories, increasing the size of that sales division and expanding our medical science liaison capabilities. In addition, we added a new inside sales team enabling us to better support those customers outside the reach of our hospital and field sales organizations. Our goal is…

A. J. Kazimi

Management

Well, thanks for sharing that progress, Marty. I would like to now discuss our clinical update in a little more detail during 2019 we completed our third Caldolor pediatric study which fulfilled our commitments to the FDA associated with the products original approval. We have previously completed both fever and pain studies in older children and then able to expand Caldolor’s label with FDA approval for the products use in children 6 months of age and older. We have followed them with a study in new borns ranging in age from birth up to 6 months. The trial enrolled 24 newborns at 4 medical centers across to country and was designed to evaluate the safety and pharmacokinetics of Caldolor in those youngest of patients today. I am pleased to report that during the course of the clinical study we did not see any significant safety concerns in these very young children. We also observed that the pharmacokinetics of Caldolor behaves similarly between these newborns and the children greater than 6 months of age. Based on that data, it appears that Caldolor dosed at 10 milligram per kilogram every 6 hours is well-tolerated and appropriate for children ages birth on up. Our next steps are to complete the full study report and then submit that information to the FDA. Our Caldolor clinical studies have now involved nearly 2,000 patients resulting in outstanding safety database and we are planning to further expand the products label based on this wealth of new data. During 2019, we submitted it to the FDA aiming to further expand Caldolor’s label and this update included some more geriatric, pediatric, pharmacokinetic data as well as data on a shortened infusion time. Well, due to the number of new clients, the FDA requested that we divide the new data…

Michael Bonner

Chief Financial Officer

Thank you, A. J. For the 3 months ended December 31, 2019, net revenues were $13.7 million compared to $13.5 million for the prior year period. Net revenues by product for the fourth quarter included $4.4 million for Ethyol, $3.2 million for Kristalose, $2.5 million for Vibativ, $1.7 million for Caldolor, and $1.2 million for Acetadote. For the full year ended December 31, 2019, Cumberland’s total net revenues were $47.5 million, a 17% increase compared to $40.7 million for the prior year period. Net revenues by product for the full year 2019 included $12.9 million for Kristalose, $12.8 million for for Ethyol, $8.7 million for Vibativ, $5.2 million for Caldolor, and $3.8 million for Acetadote. Total operating expenses for the 3 months ended December 31, 2019 were $14.7 million down from $15.8 million for the prior year period. For the full year ended December 31, 2019, our total operating expenses were $51.2 million compared to $48.1 million for 2018. This increase included additional cost of products sold and an increase in the amortization of non-cash expense. Adjusted earnings for the 3 months ended December 31, 2019 were $1.5 million or $0.09 per share compared to $1.6 million or $0.10 per share for the prior year period. Adjusted earnings for the year ended December 31, 2019 were $5 million or $0.32 per share, a significant increase over the loss of $0.5 million or $0.03 per share in the prior year period. As of December 31, 2019, we had $104.5 million in total assets, including over $28 million in cash and investments. Liabilities totaled $53.5 million, including $18.5 million on our credit facility. Total shareholders equity was just over $51.1 million at the end of the year. As a reminder, the financial terms for the Vibativ acquisition included a $20 million payment…

A. J. Kazimi

Management

Thank you, Michael. Well, as you have heard, we are working hard to build a specialty pharma business that delivers sustained growth and profitable operations. We are hopeful for the potential of the key catalysts we reported on today, which include the contributions from the Vibativ acquisition, the national launch of our new Caldolor presentation and the pending launch of the RediTrix product line. We believe these brands will be important contributors to the growth in 2020 and for years to come. The addressable markets are quite large for a company our size and if we are able to maximize the potential of these brands we believe it could have a significant impact on our value. As we move into 2020, we will be supporting a more focused portfolio and valuable brands we will continue our business development initiatives selectively add new commercial brands as well as new partners. We will also work to develop and register new product candidates that address unmet medical needs. We expect that 2020 would be a successful year for Cumberland. We are targeting a number of important accomplishments during the year and as of today we are aiming or double digit revenue growth this year over 2019. Our goal is to deliver positive cash flow from our operations, and we expect to continue to return capital to our shareholders though share repurchase and other initiatives while being careful not to impact our growth opportunities. Meanwhile we do recognize the importance of managing our supply chain and continuing to deliver our medicines needed by patients during the national coronavirus outbreak. And as Marty mentioned we are taking specific action to ensure ongoing access to the medical community to support patient care and also to maintain the needed interactions among our national sales organization to support our brands. And finally I would just like to acknowledge and thank our team, we had a terrific year in 2019 and we appreciate all their efforts and contributions. Our goals are to advance patient care to the delivery of high quality medicines or also building value for all involved in our organization. So with that review and that update now, let’s open the call to any questions you may have. Operator, can you please proceed?

Operator

Operator

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

Andrew D'Silva

Analyst · B. Riley FBR. Your line is now open

Hi, yes, good afternoon. Thanks for taking my questions and I hope everyone is okay for the tornadoes. Just curious if there has been any sort of disruption due to the tornadoes or COVID-19, I am really curious about how you are managing the business from the sales and marketing standpoint, are currently just due to some of the restrictions that have been implemented and if we should just consider that as a buyable impact to your top line this year?

A.J. Kazimi

Analyst · B. Riley FBR. Your line is now open

Well, good afternoon. This is A. J. and I will address the tornado and I will turn to Marty to talk about what we are doing from the commercial perspective regarding the coronavirus outbreak. You are correct, we encountered 6 different tornadoes, which are landed in this area recently and which caused extensive damage and unfortunately also there was a considerable loss of life. Fortunately our business and our team was largely unaffected nobody at Cumberland was hurt and there was no significant damage to the operations of the company the facilities of the company or even the homes of our team members. So thankfully we survived those tornadoes. And again, I will now turn to Marty to describe what we are doing regarding the COVID-19 outbreak?

Marty Cearnal

Management

Yes, hi. Our goal continues to focus on delivering double-digit revenue growth in 2020. We believe that business like ours is less impacted by any economic downturn. Patients will still need medications to support their health and treat their conditions in some of our medications are particularly useful in these difficult situations. Furthermore, our Caldolor product can help treat high fevers associated with viral infections, while our Vibativ product is approved for the treatment of hospital-acquired pneumonia, which can be a major factor secondary to COVID-19 respiratory disease. So we think that we are well positioned and we have been working with our sales organization to assure that we maintain appropriate contact.

Andrew D'Silva

Analyst · B. Riley FBR. Your line is now open

Okay, thank you for the color. And then as it relates to the next-generation Caldolor launch, can you give a little bit of insight as far as maybe year-to-date or from whatever the timeframe you can from when you actually formally launched the product to now roughly what percent of the suggestions or hospitals that you are working with the transition to the next-generation versus the last generation Caldolor?

A.J. Kazimi

Analyst · B. Riley FBR. Your line is now open

We have seen significant adoption of the new presentation. We currently sell both forms of the product, because hospitals prefer to use the vials in their paediatric patients where they can mix several bags as these patients require lower doses. And as we reported during the call, for those hospitals that are making the change, we are seeing significant uptake and expansion. One of the reasons for that is as we get the product out of the pharmacy and into the Pyxis machines up on the floor, it’s much more convenient for the product to be used in various parts of the hospital, so not only in surgery, but in OB/GYN, in pediatrics, in ER and even in plastic surgery. So, we are seeing an expansion in the areas of use based on making this product more convenient.

Andrew D'Silva

Analyst · B. Riley FBR. Your line is now open

Okay, great. And just last question for me, if you could just let me know how you are going to account for the Clinigen financial consideration, is that going to be an other revenue line or will anything actually have to be moved over from a financial consideration standpoint into discontinued operations?

Michael Bonner

Chief Financial Officer

It will be considered discontinued operations. That way when you have a comparative number for 2019 versus 2018, they will both be in. The revenue component of that will be considered as revenue.

Andrew D'Silva

Analyst · B. Riley FBR. Your line is now open

So, to the $5 million financial consideration over 2 years will be on the top line as other revenue?

A. J. Kazimi

Management

Yes, top line revenue.

Andrew D'Silva

Analyst · B. Riley FBR. Your line is now open

Okay, perfect. Thank you very much and best of luck in 2020.

A. J. Kazimi

Management

Thank you.

Operator

Operator

Thank you. At this time, I would like to turn the call back over to management for any closing remarks.

A. J. Kazimi

Management

Okay. Well, we appreciate everyone joining us today. As I have mentioned in the past, we understand that many prefer a private discussion with management and if you do so, please just reach out to Erin here. And she will help you schedule and we will be happy to host such a call. We appreciate your time and interest in Cumberland and we look forward to then providing another update following the end of the first quarter.

Operator

Operator

Thank you, sir. Ladies and gentlemen, that concludes our conference call today. If you would like to listen to a replay of today’s conference, please dial 855-859-2056 using the access code 9759981. Alternatively, a replay of the webcast will be available on the company’s website. I would now like to thank you for your participation. You may now disconnect.