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Edited Transcript of ARLZ earnings conference call or presentation 13-Mar-18 12:30pm GMT

Thomson Reuters StreetEvents

Q4 2017 Aralez Pharmaceuticals Inc Earnings Call

Milton Apr 2, 2018 (Thomson StreetEvents) -- Edited Transcript of Aralez Pharmaceuticals Inc earnings conference call or presentation Tuesday, March 13, 2018 at 12:30:00pm GMT

TEXT version of Transcript

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Corporate Participants

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* Adrian Adams

Aralez Pharmaceuticals Inc. - CEO & Director

* Mark A. Glickman

Aralez Pharmaceuticals Inc. - Former Chief Commercial Officer

* Michael Kaseta

Aralez Pharmaceuticals Inc. - CFO & Corporate Controller

* Nichol L. Ochsner

Aralez Pharmaceuticals Inc. - Executive Director of IR & Corporate Communications

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Conference Call Participants

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* Antonia Borovina

Bloom Burton & Co., Research Division - Associate of Equity Research

* David Bautz

Zacks Investment Research, Inc. - Senior Biotechnology Analyst

* Keay Thomas Nakae

Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics

* Raghuram Selvaraju

H.C. Wainwright & Co, LLC, Research Division - MD in Equity Research & Senior Healthcare Analyst

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Presentation

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Operator [1]

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Greetings, and welcome to Aralez Pharmaceuticals Fourth Quarter 2017 Earnings Call. (Operator Instructions) As a reminder, this conference is being recorded.

It is now my pleasure to introduce Adrian Adams, Chief Executive Officer of Aralez Pharmaceuticals. Please go ahead.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [2]

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Good morning, everyone, and thank you for joining this webcast to discuss the 2017 fourth quarter and full year financial results for Aralez Pharmaceuticals. Joining me on today's call are Mike Kaseta, Interim Chief Financial Officer; Mark Glickman, Chief Commercial Officer; and Nichol Ochsner, Executive Director of Investor Relations and Corporate Communications.

Before I proceed, I would like to ask Nichol to say a few opening remarks. Nichol?

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Nichol L. Ochsner, Aralez Pharmaceuticals Inc. - Executive Director of IR & Corporate Communications [3]

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Thank you, Adrian. Earlier today, we issued a press release summarizing our December 31, 2017, fourth quarter and full year financial results, among other things, which can be found on the EDGAR and SEDAR databases and on our website at aralez.com.

Additionally, I would like to remind everyone that we have a slide presentation to accompany our conference call this morning, which can also be viewed at our website. If you are listening to this call on your telephone, you may access the synchronized slide deck on our website by choosing the link on our webcast page that says, "click here to listen."

Before we begin, I would like to remind you that certain statements made during today's call may contain forward-looking statements under applicable securities laws. Forward-looking statements include statements regarding our 2018 financial guidance. Forward-looking statements may also include those described in the disclaimer on Page 2 of the slide presentation. Any forward-looking statements are based on management's current assumptions and expectations and are subject to risks and uncertainties that could cause actual results to vary significantly from those set forth in the forward-looking statements. These important factors are described in our earnings press release we issued this morning in the company's annual report on Form 10-K for the year ended December 31, 2017, which will be filed later today. You may obtain free copies of these documents and other related documents filed with applicable securities regulators at our website aralez.com, under the heading Investors or on SEC's website at sec.gov or on SEDAR at sedar.com. We undertake no obligation to update these forward-looking statements, unless required by applicable law.

This presentation also contains non-GAAP financial measures. The reconciliation of such measures to the most comparable GAAP figures is included in our fourth quarter and 2017 year-end earnings release issued earlier today. I would also note that all dollar amounts referenced on this call are references to U.S. dollars, unless otherwise noted.

With that, I'll turn the call back over to Adrian.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [4]

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Thank you, Nichol. On Slide #3, you will find the agenda we would like to cover for today's call. I will open with an overview of our 2017 achievements and a summary of recent updates that have taken place with the Aralez business. I will then provide brief performance updates for our product portfolio with a specific focus on ZONTIVITY, the TOPROL-XL franchise and our Canadian business. Mike will then discuss our financial results and provide our 2018 financial guidance. Following that, I will briefly conclude by summarizing what we believe will be our pathway to profitability before opening the call up, as always, for your valued questions.

Turning now to Slide #4. Let me review some achievements on recent updates before reviewing some key financial accomplishments. On the commercial front, in June, we successfully repositioned and relaunched ZONTIVITY with a focus on the reduction of thrombotic cardiovascular events in the peripheral artery disease, or PAD, and persistent-risk patient population. With this said, we were very pleased to achieve new highs in both new and total prescriptions within just 8 weeks of the full relaunch and with the sales force of only 75 representatives. Clearly, we are still very early in the launch phase, but remain enthusiastic about the potential of this product.

We also continue to believe there is significant financial value in the TOPROL-XL franchise. In November, we entered into an agreement with Lannett Company, Inc. to replace Endo/Par as our TOPROL-XL authorized generic distributor beginning in late December 2017, which we expect will become economically beneficial to Aralez. Additionally, we are pleased that the Canadian organization continues to perform well, driven by a successful launch of BLEXTEN, and ongoing strong performance of Cambia.

Turning now to some recent updates. Earlier this morning, we announced that we have made the decision to discontinue Yosprala in the United States. This decision has been factored into our 2018 financial guidance. We would like to thank both the Yosprala patients and health care practitioners for their loyalty. However, with rapidly evolving market dynamics and increased pricing pressures, it proved difficult to justify continuing with the product despite significant commercial and financial efforts in 2017. As a result, we are reprioritizing our portfolio, which I will discuss in more detail later in this presentation.

During 2017, we also implemented several initiatives in an effort to create a pathway to becoming a profitable company on an adjusted EBITDA basis. Last year, we began executing a plan to significantly reduce costs and streamline the U.S. business. With this said, we are delighted to have achieved positive quarters of adjusted EBITDA in both the third and fourth quarters of 2017, and we expect this trend to continue as reflected in our 2018 financial guidance.

Turning important to the financial results we announced this morning. We are pleased to report a very solid fourth quarter of 2017 with net revenues reaching $28 million and full year 2017 net revenues reaching $105.9 million, a $51.6 million increase compared to full year 2016. As mentioned, we also achieved our second consecutive quarter of positive EBITDA on an adjusted basis. And finally, through continued financial discipline and commercial execution, we exceeded our original and achieved our improved 2017 financial revenue guidance and met our adjusted EBITDA guidance for the year. We believe, we are positioned nicely to produce significant adjusted EBITDA in 2018.

Now moving to Slide #5. I would like to review early prescription trends for ZONTIVITY in just a little bit more detail. We remain extremely pleased with the launch of ZONTIVITY. A full relaunch in early June resulted in an immediate and significant improvement in weekly prescription volume. Looking more closely at the fourth quarter, we saw a 22% increase in new prescriptions over the third quarter, a 32% increase in total prescriptions and a 39% increase in retail prescription equivalents or RPEs. As a reminder, we believe that the RPE metric, our total pill count divided by 30, offers a good measure of performance because it reflects the fact that many ZONTIVITY prescriptions are written for more than a 30-day supply. Currently, we are seeing about 48 pills for the average total prescription for ZONTIVITY.

Let's now turn to Slide #6, which shows more recent prescription performance. Although we experienced some softness in the early part of this year, a time that can be disruptive with the resetting of insurance plans, you can see that we are now back on our expected trajectory. For the third consecutive week, ZONTIVITY prescriptions have been increasing nicely and importantly, all metrics have reached new all-time highs. We believe that we have appropriately and successfully repositioned ZONTIVITY in the minds of our targeted prescribers and have tapped into a physician and patient audience seeking therapeutic options for an ongoing unmet need.

Turning to our next slide, Slide #7. Let's discuss some additional launch indicators for ZONTIVITY. With regard to the product's performance, we grew prescribing significantly in our target market, which is comprised of both cardiologists and primary care physicians, and in the fourth quarter reached new all-time highs across all prescription metrics. In 2017, ZONTIVITY achieved approximately 8,000 new prescriptions, approximately 16,000 total prescriptions and approximately 25,000 RPEs. As a reminder, ZONTIVITY was only promoted for the last 7 months of 2017. Over the course of that 7-month period, the total number of writers increased 52%, which helped to fuel our growth as we increased new prescriptions 219%, total prescriptions 146% and RPEs by 178%. We believe this momentum is being driven by our refined positioning as well as focused prescriber targeting. Importantly, we're also seeing a steady, consistent increase in refills, another sign of continued healthy growth. Since our June full relaunch through December, of the prescriptions being generated by our 3 primary targets, 65% are coming from cardiologists, 25% from primary care physicians and 4% from vascular surgeons. As a reminder, our 75% sales team is detailing ZONTIVITY to a target physician population of approximately 12,000 physicians, which represents a 25% coverage of the oral antiplatelet market.

ZONTIVITY is achieving market share growth. Specifically, new-to-brand share within all targets has increased significantly since June. ZONTIVITY has already achieved a 1.9% new-to-brand share within our target audience. As a reminder, the new-to-brand share metric quantifies those patients who are new to prescription therapy in the category in the last 12 months.

Our total market share reached 0.3% amongst our targets. We're also very pleased that ZONTIVITY's managed care coverage remains very strong with an addition of approximately 210 million covered lives, resulting in approximately 90% of commercial lives and approximately 90% of Medicare Part D lives currently being covered.

Now moving to Slide #8. I would like to summarize our commercial strategy and objectives for ZONTIVITY. Our commercial strategy is to educate the fact that PAD is an independent risk factor, increasing urgency to diagnose and manage. We believe, it is important to ensure that patients with peripheral vascular risk can be properly identified, so appropriate action can be taken to reduce cardiovascular threats. We strive to effectively reinforce ZONTIVITY as the choice to help reduce the risk of thrombotic cardiovascular events in post MI or PAD patients with persistent vascular risk.

Turning to our 2018 objectives for ZONTIVITY. We're aiming to grow total prescriptions threefold to a range of 45,000 to 55,000 and RPEs threefold to a range of 75,000 to 90,000. We also strive to grow total market share among our targets to 0.9%, up from 0.3% in 2017. In looking deeper at potential market opportunity, we believe a 6% market share among our targets could translate to $100 million peak sales opportunity. In summary, we remain extremely encouraged with the performance of and potential for future growth with ZONTIVITY.

Turning to Slide #9. Let's review our 2018 strategy and objectives for the TOPROL-XL franchise. Firstly, let me comment, the prescriptions remained strong in 2017, as reported by Symphony Health. In addition, roughly 60% of revenues generated came from the branded product and approximately 40% from the authorized generic. Although this mix could fluctuate over time, we remain pleased with the overall stability of the TOPROL-XL franchise in 2017.

We recently started a targeted promotion strategy and began promoting TOPROL-XL in a P2 position behind ZONTIVITY to leverage the branded products. We are utilizing a patient direct program through a dedicated branded supplier via an exclusive pharmacy to drive branded prescriptions and indeed refills.

Beginning in 2018, we record our sales of TOPROL-XL or supply sales of the authorized generic to Lannett, plus our share of Lannett's profits on its sales of the authorized generic within revenues on our income statement. In 2018, revenues are now recorded as total net product sales or on a gross basis.

Our 2018 objectives of the franchise include continued, strong and commercial financial discipline. As we expected, a generic entrant was approved in February 2018, and this is being factored in our 2018 financial guidance. Assuming no additional generic entries, amongst other things, we expect 2018 to exceed last year's revenue performance and perform consistently with a historical run rate.

Our assumptions include expected improved economics, volume and margins with the TOPROL-XL franchise in 2018. Additionally, we recently met milestones that in accordance with our agreement with AstraZeneca, will be payable in the amount of $5.6 million per quarter, starting in mid-2019 through 2021 with no milestone payment obligations in 2018.

We also continue to have a long-term supply agreement with AstraZeneca for the brand and authorized generic, which is important given the well-known difficulty in manufacturing this product. Overall, we are pleased that the TOPROL-XL franchise continues to be a valuable financial asset, generating significant revenues and cash flow for Aralez.

Before handing over to Mike to review our financial performance, I would like to refer finally to Slide #10, where I will briefly provide an overview of the growth drivers for our Canadian business.

Revenues were $26.8 million for the full year 2017 compared to $24.2 million in 2016. We are pleased that in addition to this revenue growth, the Canadian business continues to generate positive adjusted EBITDA. The key contributors to this solid quarterly performance continue to be from the growth driver brands, CAMBIA and BLEXTEN. We are particularly pleased that in the first year of promotion, BLEXTEN achieved a 4.4% market share. We estimate that the 2017 prescription antihistamine market in Canada is valued at approximately $37 million.

The overall business in Canada remains very strong, despite generic erosion of some of the other brands, such as Fiorinal and Bezalip SR during 2017. Looking ahead, we remain focused on maintaining an efficient, productive and profitable business in Canada.

With that, I would now like to hand the call over to Mike Kaseta to review our financial results and outlook in more detail. Mike?

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [5]

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Thank you, Adrian. Good morning, everyone. Today, I'll be reviewing our fourth quarter and fiscal year 2017 GAAP financial results and adjusted EBITDA. I will also provide 2018 financial guidance. Our press release this morning provides our financial results for the fourth quarter and fiscal year 2017, as well as the reconciliation to GAAP for our non-GAAP financial measures.

Overall, we're very pleased with our results. Later today, Aralez will file its annual report on Form 10-K, which will also include our fiscal year 2017 results, and I encourage you to review that report. As a reminder, our merger with Tribute, now known as Aralez Canada, closed in February 2016, our acquisition of the U.S. and Canadian rights to ZONTIVITY closed in September of 2016, and our acquisition of the U.S. rights for the TOPROL-XL franchise closed in October of 2016. Our consolidated results of operations for 2016 include the results of Aralez Canada from February 5 through December 31, 2016; ZONTIVITY from September 6 through December 31, 2016; and the TOPROL-XL franchise from October 31 through December 31, 2016.

Let's now turn to Slide 12, which covers our revenue growth for both the fourth quarter and fiscal year 2017. We're pleased to report that our total revenues for the fourth quarter of 2017 were $28 million compared to $20 million during the fourth quarter of 2016, an increase of $8 million. Total revenues for the fiscal year 2017 were $105.9 million compared to $54.3 million for the fiscal year 2016, an increase of $51.6 million. We have broken down our revenues into 3 categories: One, U.S. core business, which includes ZONTIVITY, the TOPROL-XL franchise, Fibricor and Yosprala; two, our Canadian products; and three, VIMOVO royalties and license fee revenue.

U.S. core business revenues grew from $8.8 million in the fourth quarter of 2016 to $17 million during the fourth quarter of 2017. We also saw U.S. core business revenue growth from $10 million for fiscal year 2016 to $59.9 million in 2017. This increase was primarily driven by the acquisition of TOPROL-XL franchise and ZONTIVITY.

Canadian product revenues, which are generated from products we acquired through the Aralez Canada acquisition, increased from $6.2 million in the fourth quarter of 2016 to $7 million in the fourth quarter of 2017. This increase was primarily driven by the growth from BLEXTEN and CAMBIA. Canadian product revenues increased from $24.2 million in fiscal year 2016 to $26.8 million in 2017. Contributing to this increase with the net product revenues from BLEXTEN and CAMBIA, partially offset by lower Bezalip, Proferrin and Fiorinal revenues due to generic competition.

As a reminder, our 2016 Canadian product revenues, including revenues for the period February 5, the date we closed the Tribute merger through December 31, 2016. Royalties and license fee revenues decreased from $5 million in the fourth quarter of 2016 to $4 million in the fourth quarter of 2017, primarily due to lower net pricing from VIMOVO in the U.S. Pursuant to our agreement with Horizon and subject to certain conditions described in our public filings, we are guaranteed a quarterly minimum royalty amount in the U.S., which is calculated based on an annual minimum royalty of $7.5 million, which is reflected in our fourth quarter results. Ex-U. S. royalties continue to be relatively stable in 2017. Fiscal year 2017 royalties and license fee revenues totaled $19.3 million and were comprised of VIMOVO royalties of $15.3 million and a $4 million license fee received pursuant to a license agreement executed in May of 2017. Fiscal year 2016 royalties and license fee revenues were comprised solely of VIMOVO royalties of $20.1 million. This decrease in VIMOVO royalties is driven by the lower net pricing in the U.S.

Now moving to Slide 13. I'd like to cover quarter-over-quarter adjusted EBITDA improvement. Since the fourth quarter of 2016, we have demonstrated our commitment to improving our profitability on an adjusted EBITDA basis. As you may recall, in April 2017, we announced cost savings initiatives, including a 32% reduction in our sales force, a reduction in Yosprala marketing spend and other departmental cut. At the same time, we announced the $7 million marketing investment in the relaunch of ZONTIVITY in June of 2017. This two-pronged approach of cost savings initiatives and targeted investment in growing our revenues, set the stage for our first quarter of positive adjusted EBITDA in the third quarter of 2017. We have continued this momentum in the fourth quarter as we achieved another quarter of positive adjusted EBITDA. We expect this adjusted EBITDA improvement trend to continue throughout 2018.

Moving on to Slide 14. Aralez's costs and expenses for the fourth quarter and fiscal year 2017 included $4.7 million and $13.5 million, respectively, in cost of product revenues; $8.6 million and $34.3 million, respectively, of amortization of the intangible assets from the Aralez Canada, ZONTIVITY and the TOPROL-XL Franchise acquisitions; and $23.1 million and $35.7 million, respectively, in expenses related to the change in fair value of continued consideration from the TOPROL-XL franchise and ZONTIVITY acquisition. This increase in change in fair value of the contingency consideration is attributed to a significant increase in financial projections for ZONTIVITY and the achievement of certain milestones, as Adrian earlier described.

SG&A expenses were $28.8 million for the fourth quarter of 2017 compared to $32.9 million in the fourth quarter of 2016. The decrease is primarily driven by lower promotional costs, primarily for Yosprala, and decreased cost to our U.S. sales force as a result of our cost-saving initiatives announced in the second and fourth quarters of 2017. We now maintain a sales force of approximately 75 sales representatives compared to roughly 105 sales representatives for most of the fourth quarter of 2016.

SG&A expenses were $116.6 million for fiscal year 2017 compared to $118.5 million in 2016. This decrease is primarily due to lower transaction-related costs incurred during 2017, partially offset by increased costs for our U.S. sales force and increased promotional cost for ZONTIVITY. Interest expense of $6.8 million in the fourth quarter of 2017 and $27 million for the fiscal year 2017 relates to our borrowing of $200 million under our credit facility in the fourth quarter of 2016, pursuant to the acquisitions of ZONTIVITY and TOPROL-XL franchise and our $75 million of convertible notes.

Our net loss for the fourth quarter of 2017 was $45.8 million or $0.68 per diluted share compared to a net loss of $31.1 million or $0.48 per diluted share for the fourth quarter of 2016. Our net loss for the fiscal year 2017 was $125.2 million or $1.89 per diluted share compared to a net loss of $103 million or $1.74 per diluted share for fiscal year 2016.

Please turn to Slide 15 for adjusted EBITDA growth for the fourth quarter and fiscal year 2017. We have provided our GAAP to non-GAAP reconciliation, which illustrate non-cash share-based compensation and certain other discrete items impacting the 3 months and 12 months ended December 31, 2017, and 2016, respectively. We achieved positive adjusted EBITDA for the second consecutive quarter at Aralez in the fourth quarter of 2017. Adjusted EBITDA for the fourth quarter of 2017 was $2.1 million, an increase of $14 million compared to negative $11.9 million for the fourth quarter of 2016. Adjusted EBITDA for fiscal year 2017 was negative $4.5 million, an improvement of $42.2 million compared to negative $46.7 million for fiscal year 2016.

From a balance sheet perspective, we ended the quarter with approximately 67 million shares issued and outstanding and cash and cash equivalent of $28.9 million. With our expected revenue growth and previously announced cost reductions, we believe we have sufficient cash to fund our operations for the next 12 months. As we look forward, we continue to focus on driving revenue growth while also prudently managing our expenses. We also continuing to explore ways to refinance our debt and improve our capital structure.

Moving to Slide 16. Let's review our financial guidance for 2018. These estimates reflect our current beliefs about, among other things, prescription trends; competition, including no additional TOPROL-XL generic entrant in 2018; pricing level; inventory levels; and anticipated future events and are subject to other material factors and risks more particularly described in our earnings release and public filings.

With the expected growth in revenues and previously announced expense reductions, our net revenue guidance for 2018 is a range of $140 million to $160 million in net revenue and $35 million to $55 million in adjusted EBITDA. Our earnings release contains further information regarding these assumptions, underlying our 2018 non-adjusted EBITDA as well as the reconciliation.

With that, I'll turn the call back over to Adrian for some final comments.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [6]

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Thank you, Mike. Now please refer to Slide #17 to see an illustration that we believe demonstrates our business is on course to deliver a nice evolution in revenues and meaningful growth in adjusted EBITDA year-over-year. Looking at the graph on the left, you can clearly see the upward revenue growth and similar upward trajectory for adjusted EBITDA that illustrates our expected pivot into a profitable, on an adjusted-EBITDA-basis company in 2018.

With that, I would like to finish with our final slide, Slide #18, which summarizes our planned pathway for Aralez to become a profitable company. To recap, we had a strong revenue performance in both the United States and Canada in 2017. We also made broad efforts to streamline our U.S. business with a focus on ZONTIVITY and the TOPROL-XL franchise, together with a solid Canadian performance to drive momentum. We believe, we are now moving into a positive adjusted EBITDA company. Our 2018 revenue projections reflect projected growth of ZONTIVITY and expected improvements in TOPROL-XL franchise revenues. Our financial improvements to streamline SG&A expenses, along with enhanced revenues, are expected to produce significant adjusted EBITDA in 2018 and beyond. And we will continue to evaluate strategic business opportunities throughout the year, including to potentially refinance our debt.

In conclusion, we are pleased with both the fourth quarter and full year 2017 financial results and believe that our stronger financial outlook in 2018 provides a pathway to improve our overall capital structure.

We thank you for your continued interest and support. I would now like to open up the call for your valued questions. Operator, can you please give the instructions.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question is coming from the line of Ram Selvaraju with H.C. Wainwright.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD in Equity Research & Senior Healthcare Analyst [2]

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Firstly, Yosprala. Can you tell us approximately what remaining revenue you derive from the product now that you've made the decision to discontinue it in the United States, and specifically at what juncture that decision took place so that I know exactly when the U.S. Yosprala revenue effectively came to an end?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [3]

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Well, I think, obviously, as it relates to -- as we mentioned on our call, I think the decision firstly on discontinuing Yosprala was dictated by limited kind of evolution in prescription trends during 2017. So we took the difficult decision, as we indicated, to discontinue efforts with Yosprala, and we hope to wrap it up in the very near future. Within all kind of financial statements, we've not shared the specific revenue results for Yosprala, so I don't want to comment on those at this particular point in time. But clearly, I think we put a lot of effort into this asset during 2017, and we felt we were not getting the return on that, but we did feel that the returns we will get on the TOPROL-XL franchise, on ZONTIVITY would obviously aid and support reprioritization. Mike, do you want to add anything to that?

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [4]

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Yes. I mean, as Adrian stated, we do not disclose revenue by product, and as we are winding down the products at the end of Q1, we would expect the sales to tail off as we move to the tail end of Q1.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD in Equity Research & Senior Healthcare Analyst [5]

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Okay. And then just very quickly, with respect to the Canadian business. This $26.8 million that you reported for 2017, do you anticipate that, that is likely to grow in 2018? And can you clarify whether, in fact, this amount corresponds to all the revenue that is being generated by the company outside of TOPROL-XL, ZONTIVITY, Yosprala and the VIMOVO royalty stream?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [6]

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Yes. On the latter point, I think you're right in that conclusion. I think obviously from a Canadian perspective, we referenced that we were very pleased with the way CAMBIA and BLEXTEN are performing. BLEXTEN has had a superb launch in Canada. We've not broken out specifics in relation to Canadian revenues, as we've indicated I think, but certainly, I think, given the evolution that we see in the business, we expect the company to continue to deliver significant adjusted EBITDA on an ongoing basis. Mike, you want to add anything to that?

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [7]

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Yes. So Ram, to your second part of the question, the one product that is also in addition to ZONTIVITY, VIMOVO and TOPROL in the Canadian business has been recorded, which we continue to generate sales into 2018.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD in Equity Research & Senior Healthcare Analyst [8]

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Okay. And then my last question is with respect to this change in fair value of contingent consideration line item in the fourth quarter of 2017. How should we be thinking about that going forward? And can you comment on its nature, specifically in the fourth quarter of 2017? What was this? I think it was $23 million approximately.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [9]

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Sure. As part of our closed process, we are required to update our valuation of our [contingent] consideration liability, which is comprised mostly of future expected payments [with] contingent consideration on both TOPROL and ZONTIVITY. As part of that analysis at the end of Q4, we had to update financial projections and as a result of increased financial projections of future revenues of ZONTIVITY and also through the achievement of certain milestones relating to TOPROL, those were the 2 main drivers that led to the significant increase in the change in contingent consideration in Q4 of 2017.

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Raghuram Selvaraju, H.C. Wainwright & Co, LLC, Research Division - MD in Equity Research & Senior Healthcare Analyst [10]

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But it's effectively a non-cash impact. Is that correct?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [11]

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Absolutely.

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Operator [12]

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The next question comes from the line of Keay Nakae with Chardan Capital.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [13]

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First, could you comment on the current pricing environment for the generic version of TOPROL-XL?

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Mark A. Glickman, Aralez Pharmaceuticals Inc. - Former Chief Commercial Officer [14]

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This is Mark. Right now, we're seeing -- it really seems fairly stable to us right now. We haven't seen really any changes at all in the pricing dynamics in the TOPROL market. And keep in mind with the AG, we may be -- we have a little bit of less sensitivity than maybe some of the true generics, but right now, everything seems quite stable.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [15]

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Okay. And then with respect to the payments that will be due to AZ, can you give us a little more detail on that? I know you said it starts middle of this year, but is this for a specific number of quarters, like -- just give us more detail, so we can model it out a little bit, more accurately.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [16]

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Yes. I'll ask Mike to comment on that. Firstly, I think they begin in middle of 2019, not this year. But Mike, maybe you can call in.

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [17]

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Absolutely. So in accordance with our agreement with AZ, certain milestones were met that require us to make $45 million of quarterly payments that will commence in Q2 of 2019 and be paid evenly through Q2 of 2021.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [18]

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Okay. And then with respect to SG&A, sequentially you saw about $4 million increase. Can you talk about that and what's the baseline going forward?

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [19]

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So when you look at sequentially from Q3 to Q4, we did have an increase of $4 million, primarily driven -- or really driven by a couple of areas. One is to really fuel the growth of ZONTIVITY as we move into 2018. We did look to make some additional investment in Q4. And then there were certain items that were paid relating to the settlement of our PAR agreement before we transition -- as we transition to Lannett, that will be non-recurring, and they also occurred in Q4 of 2017. As we look into 2018, I think when you look at our revenue guidance and our adjusted EBITDA guidance, that significant growth in adjusted EBITDA in 2018 is being driven by reductions in our SG&A expenses, as we have -- through our previous announcements of cost reductions in both Q2 and during our Q3 call, we've rightsized the organization to support the continued growth of ZONTIVITY, our growth in Canada and maintaining TOPROL, and we feel that we are in a good position now to support that growth and to deliver that $35 million to $55 million of adjusted EBITDA in 2018.

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Keay Thomas Nakae, Chardan Capital Markets, LLC, Research Division - Senior Research Analyst of Therapeutics, Devices and Diagnostics [20]

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Okay. Just following up on that, when we're considering the $4.3 million in transaction-related expense in the adjusted EBITDA, what's in that bucket?

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Michael Kaseta, Aralez Pharmaceuticals Inc. - CFO & Corporate Controller [21]

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Yes so. That includes -- it primarily relates to a settlement payment that we made to PAR as we transition to the Lannett agreement at the end of 2017.

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Operator [22]

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Our next question is from the line of David Martin with Bloom Burton.

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Antonia Borovina, Bloom Burton & Co., Research Division - Associate of Equity Research [23]

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It's Antonia on the line for Dave. So our first question is related to TOPROL. Based on Symphony data, we're seeing a 30% decline in scripts from early December. So I was just wondering, if you can comment on whether this is reflective of actual sales trends or if maybe Symphony is missing something?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [24]

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Yes, I'll ask Mark Glickman to comment on that.

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Mark A. Glickman, Aralez Pharmaceuticals Inc. - Former Chief Commercial Officer [25]

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Thanks. Yes. So our -- actually, our shipment out and the entire distribution at TOPROL is exactly in line what we expected earlier this year. We do work closely with our partner, and we do believe that, that drop in market share at this point is more of a transition from PAR to Lannett [MPC] code out there and not reflective of what's going on downstream at the pharmacy level. Again, we record revenue based on what goes out and everything is fully intact, and we're -- we pretty much on a daily basis reassured that business is intact and we have not lost any business despite we seeing the Symphony data week to week.

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Antonia Borovina, Bloom Burton & Co., Research Division - Associate of Equity Research [26]

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Okay. And then again related to the TOPROL-AG. You've switched obviously from PAR to Lannett. Can you maybe comment on how much better your economics are for [Lannett] versus PAR?

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Mark A. Glickman, Aralez Pharmaceuticals Inc. - Former Chief Commercial Officer [27]

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So as a result of our new agreement with Lannett, we definitely feel that we have more favorable economics relating to both distribution and also exposure to the branded pharmacy, which will absolutely help us achieve our targets of $35 million to $55 million of adjusted EBITDA in 2018.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [28]

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In addition, I think there were many reasons why we decided to move from PAR to Lannett. One of those reason was that obviously it opens up a broader base of new customers that Lannett has in their network. So overall, whether it be in terms of the overall kind of share, and but also the broader economics involved in this, we feel that it was a very good move, and as we move through the course of 2018, we will see the benefits unfolding as we go through the course of the year.

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Antonia Borovina, Bloom Burton & Co., Research Division - Associate of Equity Research [29]

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Okay. And then maybe finally moving on to ZONTIVITY. Can you maybe comment on what investigator-sponsored trials we're expecting to generate results this year and then maybe how big these studies are and what the endpoints will be?

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Mark A. Glickman, Aralez Pharmaceuticals Inc. - Former Chief Commercial Officer [30]

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So this is Mark again. We continued several of the [IITs] over from Merck. I'm not sure we're in a position to specifically discuss, but generally speaking, we are looking in areas of potential that may be future studies in PAD, both in symptomatic relief or to see a proof of concept of symptomatic relief and a pharmacoeconomic dynamic study. So we haven't spoken specifically about each of them, but we have several that we retain from Merck and some readouts will start in '18.

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Operator [31]

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(Operator Instructions) Our next question comes from the line David Bautz with Zacks Investment Research.

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David Bautz, Zacks Investment Research, Inc. - Senior Biotechnology Analyst [32]

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So I'm wondering if M&A is something that's really near the top of the company's priority list for the year or is it more [or less] something that's constantly in the background that you guys are just constantly evaluating?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [33]

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That's a good question and clearly, I think, I have commented in previous calls that obviously, last year was a challenging year for the broader specialty pharma universe. We believe that, that's led to a kind of a landscape of potential opportunities. So -- whilst we are looking obviously to execute well from a commercial and financial perspective, we are continually looking at the broader aspects of corporate rental licensing, which includes kind of M&A type of opportunities. So we'll be opportunistic, we'll be entrepreneurial, we continue to look at things and we are looking at several things as we speak, and we'll see how that unfolds during the course of this year. But one thing is for sure, the landscape that was last year, we believe, is going to get more buoyant as we moved into this year. And if we see something that looks good in relation to shareholder value creation, then clearly, we'll try and put ourselves in a position to make that happen. So I guess opportunism, flexibility and strategic thinking, all with the eyes of investors and shareholders, is our approach this year.

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David Bautz, Zacks Investment Research, Inc. - Senior Biotechnology Analyst [34]

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Okay. Now based on your projections for 2018, what's the realistic time frame for when you can possibly get the debt refinanced, and is there any type of specific metrics that you're hoping to hit before you think that could occur?

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [35]

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Well, clearly, one of the things that we are particularly delighted with -- with the finishing off last year strongly with 2 positive quarters of adjusted [EBITDA]. As you'll have recalled in our press release and on the call, I think we made reference to the fact of growing that to a range of $35 million to $55 million during the course of this year. That, in turn I think, will enhance the opportunity for us refinancing that debt. So clearly, in addition to that, moving towards that situation where we'll be able to refinance the debt, we're also looking on an ongoing basis as to whether or not there are any opportunities in other ways in which we may be able to refinance that debt. So we say, it's a key goal for this year and clearly, the movement to adjusted -- positive adjusted EBITDA through the course of this year will put us in a much better position to be able to do that.

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Operator [36]

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At this time, I'll turn the floor back to Adrian Adams for closing remarks.

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Adrian Adams, Aralez Pharmaceuticals Inc. - CEO & Director [37]

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Okay. Thank you, operator. And I'd like to thank you all for joining us this morning. And as always, we look forward to updating you on our continued progress and corporate milestones as we evolve during the course of this year. Thank you so much.

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Operator [38]

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Thank you. This concludes today's teleconference. You may disconnect your lines at this time. Thank you for your participation.