Arthur Higgins - President, Chief Executive Officer Dan Peisert - Senior Vice President, Chief Financial Officer John Thomas - Senior Vice President of Investor Relations & Corporate Communications.

Good day, ladies and gentlemen, and welcome to the Assertio Therapeutics, Q4 2018 Earnings Conference Call. At this time all participants are in a listen-only mode. Following management’s prepared remarks we will have a question-and-answer session and instructions will be given at that time. [Operator Instructions].

As a reminder, today’s conference will be recorded. It is now my pleasure to turn the conference over to your host, John Thomas, Senior Vice President of Investor Relations and Corporate Communications. Please go ahead, sir. .

Thank you, Haley. Good afternoon and welcome to our investor conference call to discuss Assertio’s fourth quarter and full year 2018 financial results announced this afternoon. The News Release and Investor Presentation covering our earnings for this period are now available on the investor page of our website at www.assertiotx.com.

I’d encourage you to review the presentation slides as they are complementary to today’s discussion. With me today are Arthur Higgins, President and Chief Executive Officer; and Dan Peisert, our Senior Vice President and Chief Financial Officer.

I would like to remind you that matters discussed on this call contain forward-looking statements that involve risks and uncertainties, including those related to the commercialization of Gralise, CAMBIA and Zipsor.

Our collaborative arrangements, including with Collegium Pharmaceutical, the company’s financial outlook for 2018, regulatory development plans, including those for long acting cosyntropin, our loan agreements including our senior secured debt facility, expectations regarding potential business and investment opportunities, and other statements that are not historical facts.

Actual results may differ materially from the results predicted and recorded. The results should not be considered an indication of future performance. These and other risks are more fully described in the Risk Factors section and other sections of our Quarterly Reports on Form 10-Q and our Annual Report on Form 10-K.

Assertio disclaims any obligation to update or revise any forward-looking statements made on this call as a result of new information or future developments.

Assertio’s policy is to only provide financial guidance for the current fiscal year and to provide updates or reconfirm its guidance only by issuing a news release or filing updated guidance with the SEC in a publicly accessible document. References of the current cash and cash equivalents are based on balances as of December 31, 2018.

All guidance, including that related to the company’s expected neurology franchise net sales, earnings and non-GAAP adjusted EBITDA are as of today.

The non-GAAP financial measures Assertio uses are not based on any standardized methodology prescribed by GAAP and maybe calculated differently from and therefore may not be comparable to non-GAAP measures used by other companies. With that, I will turn the call over to Arthur.

Arthur?.

We are extremely pleased to have achieved our goal in December of filing along with our partner West, an NDA for our long-acting synthetic cosyntropin. The FDA officially notified us that our 505(b)(2) application for a diagnostic indication was accepted for filling with a PDUFA date of October 19 of this year.

If approved, we’ll have the opportunity to launch a much needed, lower cost, synthetic long-acting cosyntropin alternative into the U.S. maybe this year or early 2020. We believe in our strategy with good reason. We conducted advisory boards with healthcare providers and payers to gauge the level of interest and acceptance.

And we've learned that they're generally aware that synthetic long-acting cosyntropin is solid by Mallinckrodt outside the U.S. and has similar indications to Acthar Gel sold in the U.S.

Their feedback leads us to believe that payers and physicians will be open to the use of our synthetic product regardless of its label providing it is priced appropriately. Importantly, we don’t need all payers or physicians onboard to have a successful new product launch.

In fact even with modest adoption of our synthetic product, we will be adding a highly attractive new asset to our Assertio portfolio, and one that will be the first in the build out of our future orphan specialty business.

Another significant achievement in 2018 was our ability to secure 97 million of non-dilutive capital due to agreements which lies with Collegium, PDL BioPharma, Ironwood and Purdue. This is an impressive amount of cash for a company of our size.

This cash, along with our free cash flow means that by April this year we will have reduced our secured debt to $202 million, down from $475 million that was present when I joined the company in early 2017.

As a result by April, our secured debt to EBITDA ratio based on the mid-point of our 2019 guidance will be approximately 1.6 and our total debt to EBITDA ratio will be approximately 4.5.

As a result of this new financial strength, we were able to modify a secured debt agreement in late December, replacing the previous fixed adjusted EBITDA covenant with a trailing 12 month debt to adjusted EBITDA ratio that declines over time.

This amendment means we have more flexibility to invest in our core business, and future BD transactions, and equally importantly means we can be more patient in any restructuring of our secured or convertible debt.

With the positive momentum we created in 2018, we are confident 2019 will prove to be another pivotal year in our transformation as we drive our three pillar strategy forward and tackle new company goals. Among our goals for the New Year, I want to outline three major ones that we are clearly focused on.

First, we are committed to achieving our new financial guidance goals, including growing our neurology franchise, net sales in the low to mid-single digits. We're also committed to delivering adjusted EBITDA of between $115 million to $125 million.

Second, we look forward to the potential approval of our long acting synthetic cosyntropin in the fourth quarter and to prepare for a market launch in late 2019 or early 2020.

Cosyntropin represents the foundation of our new orphan specialty business and offers a low cost alternative in a market dominated by one high cost, animal derived product that generates annual sales of more than $1 billion.

Third, we expect to add one or two new in-licensing assets with a strong bias towards an accretive late stage or un-market assets that complement our existing neurology portfolio. Plus we met that goal in 2018.

The fact that we continue to see attractive assets that have the potential to meet our strict investment criteria gives us great confidence and we were fortunate this year.

In summary, we are very pleased with our progress in 2018, but firmly believe 2019 will bring us even closer to our goal of a totally transformed company with sustainable growth and a promising pipeline. With that, I’ll turn the call over to Dan, who will provide more details on our performance in the fourth quarter and the full year.

He will also discuss the accounting for our amended Collegium agreement under 2019 neurology franchise and adjusted EBITDA guidance. Dan..

$10 million of cash received up-front as a one-time service fee; $6.2 million received as payment for inventory and $8.8 million of value, assigned to the warrants received as part of the amendment.

As of November 8, we had already recognize $159.4 million of revenue year-to-date under the commercialization agreement, which is greater than the 157 just described.

Thus any income received from Collegium after this date was used to reduce the contract asset of the balance sheet leaving $2.4 million as a contract asset as of December 31 to be amortized over the remaining three years.

$159.4 million is what we’ve recorded as our year-to-date GAAP revenue from the agreement and is netted against the $3.7 million royalty payable Grunenthal that was recorded in our third quarter, in accordance with our minimal royalty agreement.

Going forward, the quarterly GAAP revenue we recognize under the commercialization agreement will better match both the cash we receive and the variable royalty calculated in accordance with our agreement based upon Collegium’s net revenues from this center. We're pleased with how he finished 2018 and believe it sets the stage for 2019.

As Arthur mentioned in his remarks, our guidance for 2019 is that we will deliver low to mid-single digit growth for neurology franchise and adjusted EBITDA between $115 million to $125 million.

As is typically the case for us and most pharmaceutical companies, we expect that our first quarter neurology revenues will be the lowest of the four quarters this year.

In addition to the normal seasonality in our business, we also expect that we will see a slowing in the growth of CAMBIA due to some formulary changes that took place in January of this year. In 2018 we recorded 47% of our full year revenues in the first half.

For 2019 we anticipate it won't be materially different, but are expecting 46% over the full year in the first half. As Arthur also mentioned, we based our guidance on the Nucynta guidance provided by Collegium or $200 million to $210 million for 2019.

We expect they would have a similar seasonal pattern and as a result of the royalty structure, we'll see a strong second and third quarter royalty with the fourth quarter being the lightest quarter and that will be when we are in the 14% royalty tier.

I will also point out that given the syntax sales range they've guided to, we’ll have very little dollar exposure to fluctuations within the range, as it's entirely within the 14% tier. However, if they show upside our results will benefit as we enter the 58% royalty tier between $210 million $233 million.

As to the gating of our 2019 operating expenses, our fourth quarter 2018 operating expenses included $4.6 million of expense reimbursement from West related to costs we incurred to prepare the NDA filing of Cosyntropin that became West’s responsibility under the contract.

Our reported fourth quarter non-GAAP expenses were roughly $22 million adjusted for this $4.6 million, reflected better run rate cost structure for our business.

Adding to this run rate will be the cost to rollout the new commercial initiatives that Arthur mentioned, which will largely be incurred in the first quarter and our costs to prepare for the Cosyntropin launch. That concludes the financial discussion and I’ll now turn the call back over to John. .

Thanks Dan. And Haley, we will now take Q&A please. .

Absolutely. [Operator Instructions]. Our first question comes from Scott Henry of Roth Capital. Your line is now open. .

Thank you and good afternoon. Just a couple of questions. You’ve given EBITDA guidance for 2019. My question is have you factored any Cosyntropin revenues into that guidance or as well any expenses. How should we think about what your expectations are for that product in 2019 if at all, I know it got a late PDUFA date. .

Scott, we did not factor in any revenues in 2019. But we did factor in some initial costs to prepare for the launch for the product. .

Okay.

Will you have to add any reps for that launch?.

There will be no reps that will be promoting that product, but we anticipate that we’ll have to add [inaudible]. .

Okay, that’s helpful. And then I guess when I think about the neurology franchise, I would expect it sounds like CAMBIA is going to kind of neutralize in 2019.

As that being said, should we still expect that to be, CAMBIA to be a growth driver in 2019 or relative to 2018 revenues?.

Scott, this is Arthur. Yes, we would still expect CAMBIA to be a contributor to our growth in 2019. .

Okay, and then with Gralise, I mean how do we think about that? Is it really I mean moderating the volume declines and then offsetting that with price, perhaps that’s just more neutral.

Just trying to get a sense of what you're trying to do that franchise going forward?.

Yeah, I mean I would say of the three products that will contribute to growth, I think Gralise will contribute the least, but we still expect to see growth with Gralise in 2019, but mainly coming from price. .

Okay, and I guess the final question, just trying to get your sense of the outlook for in-licensing opportunities.

I mean are you deep along in discussions, if you're handicapping that, is it a target or do you feel like you're pretty far along as far as bringing in a couple more kind of revenue drivers?.

Scott, as I mentioned we were very disappointed that we did not meet that goal last year. It was one of the few goals that we missed and this is an organization that likes to deliver us commitments.

So as we speak, we have got several actionable targets that we’re in discussion with, but as you're aware there can be no promises on BD, but we would be extremely disappointed if we do a complete at least one late stage or on market asset that would complement our neurology franchise and I would think also one late staged product that will complement our specialty business.

So cautiously optimistic, but in this world, until the contract is signed, no promises. .

Okay, great. I appreciate that color and thank you for taking the questions. .

Thanks Scott. .

Yeah, thanks. Haley, we’ll go over the next question please. .

Absolutely! Our next question comes from Randall Stanicky of RBC Capital Markets. Your line is open. .

Hey, this is Dan Busby on for Randle. Just one big picture question for me.

Hey guys! On business development, as you built out your neurology and specialty businesses, you envision maintaining those as two largely standalone businesses and then the follow on for that would be, does that open the door to a potential split of those two businesses at some point in time if it was value creating?.

Dan, certainly we see both those business being separate. We haven’t considered a split.

I mean our first goal is to obviously develop an attractive orphan specialty business and if at some point there is greater shareholder value from looking at that, definitely I can tell you that this is a group that's very open to whatever is required to drive sustainable value. .

Okay, and then just to be clear, are you prioritizing – it sounds like you are looking at a whole lot of assets.

Are you prioritizing a neurology asset on the beacon front at this point?.

Dan, our first priority is to get an accretive asset for neurology. .

Understood. Thank you. .

Okay, thanks Dan. Haley go to the next caller. .

Okay, our next question is from Irina Koffler of Mizuho. Your line is open. .

Hi, thanks for taking the question.

Can you update us on any reimbursement discussions you are having with payers on Cosyntropin and also how quickly can this product ramp? What do you see as the key hurdles to adoption?.

Irina, first of all we continue to have very constructive discussions with payers. Well nobody discussed ramping until we get closer to launch.

But as I mentioned in my remarks, even a modest level of penetration would represent a very significant asset and some of the numbers out there, you can derive from the number of physicians who say they are interested even if we took a discount to that. I think you are talking about an asset that would be transformational from Assertio’s perspective.

.

Okay, I have a follow-up, and the Purdue bankruptcy, I was just wondering if you guys can comment on what its implications are for other parties in the case?.

First of all, I mean that’s only speculation and we're not going to comment on speculation. So, I mean I like to call them, but I really don't have any insight into that and it is only speculation at the moment..

Okay, and just one last one.

Can you provide an update on the new center appeal?.

Yeah, we are still waiting for hearing back home the appeal and we're expecting that any day now. .

Okay, thank you. .

Thanks. Okay Haley, we're ready for the next question. .

Absolutely. [Operator Instructions]. Our next question comes from David Amsellem with Piper Jaffray. Your line is now open. .

Thanks. So I just had a couple of questions on Cosyntropin. So I guess number once, since it looks like this is going to be an off label type of commercial strategy, do you have a sense of what is a realistic share that you could take from Acthar.

How should we think about that and you know what are your targets if you are willing to share that? And then secondly, any color on where you are looking to price the products, I guess on a list basis relative to that of that Acthar. Thanks..

Very good questions, but you'll not be surprised that for competitive reasons you don’t get very big answers. I think the first point I'd like to just make sure that everyone is clear. We will not be promoting this product off label. However, again we remind everybody that physicians can prescribe medicines regardless of the label.

We will be focused on payers. We have identified that 27 payers represent over 75% of Acthar business. We can mandate step add-ins or formulary restrictions regardless of the indication that the product has and that’s a dialogue that we are having with payers.

As to projection all again I would say is that even if we got a modest, a bold new share and with our – what I would call a competitive pricing discount, this would be a substantial assets for Assertio. .

Okay, well though I’d give it a shot, thanks. .

It was well worth the try. .

Anything else David?.

And I’m going to keep trying, how about that?.

You know if you keep triangulating David, one of these days, let’s hope – you could keep asking..

Alright thanks. .

Thank you very much. .

Thanks David..

Haley, are we – any other questions?.

There are no further questions at this time and Mr. Thomas, you can proceed with your closing comments. .

Okay. I want to thank everyone for joining us this afternoon. A replay of the webcast and conference call will be available shortly and for the next 30 days. Dial 1-855-859-2056 and use the passcode 37-84-827. If you have any follow-up questions, please contact us.

As a reminder our earnings release materials are posted to the Investor Relations website at assertiotx.com. I think Arthur wants to make one last closing statement. .

Yeah, I just wanted to again thank everybody who participated in today’s call and for the questions. I hope all the listeners can agree that the many actions we have taken over the last year have reshaped Assertio into a faster, leaner and more entrepreneurial company.

A company on the rise, and a company committed to getting value for our shareholders. Thanks again for your participation today. .

Thanks everyone and please contact us if you have any follow-ups.

Have a good evening!.

Ladies and gentlemen, thank you for participating in today's conference. This concludes today's programming, and you may now disconnect.

Everyone have a great day!.