Good afternoon and thank you for standing by. Welcome to the Assertio Second Quarter 2019 Earnings Conference Call. As a reminder, today's conference call is being recorded. I would now like to introduce Mr. John Thomas, Senior Vice President of Investor Relations and Corporate Communications. Sir, you may begin with the conference.

Thank you, Mel. Good afternoon and welcome to our investor conference call to discuss Assertio's second quarter 2019 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 assertiotx.com. I would encourage you to review the presentation slides as they are important 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 the 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 2019; regulatory and 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 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 to current cash and cash equivalents are based on balances as of December 31, 2018. All guidance, including that related to the company's expected total product revenues, operating expenses, adjusted non-GAAP earnings and non-adjusted EBITDA are as of today. The non-GAAP financial measures Assertio uses are not based on any standardized methodology prescribed by GAAP and may be 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?

Thank you, John. Good afternoon and welcome, everyone. I'm pleased to report that Assertio continues to deliver strong earnings, including today's second quarter adjusted EBITDA of $36.7 million. We have now beaten adjusted EBITDA expectations for the fourth time in the last five quarters as we continue the ongoing transformation into a leading diversified biopharmaceutical company. Total adjusted company sales in the second quarter of $59.2 million were also strong and included healthy commercialization agreement revenues from Collegium of $31 million. Both companies continue to be very pleased with our partnership. Neurology Franchise sales of $26.1 million were adversely impacted by Zipsor short-dated product sales returns. Excluding these sales returns, Neurology Franchise net sales, would have been close to $29 million compared to the $26.3 million in Q1 and $25.9 million in the second quarter of last year. As a result of the Zipsor sales returns, we have adjusted our Neurology Franchise net sales guidance, to low-single digits growth for the full year 2019. That's from our previous range of low to mid-single-digit growth. Nevertheless, we still remain on track with our stated goal, to having first stabilized and then return our Neurology Franchise to growth. At the same time, as a result, of our continued focus on operational efficiency. Today, we are confirming our full year earnings guidance range, for adjusted EBITDA of $118 million to $128 million. Overall, we continue to make steady progress in advancing our three-pillar strategy of maintain grow and build, as we want to transform our company, into a leading, diversified biopharmaceuticals business. Our maintain pillar continues to be one of our highlights. Built, on a strong partnership with Collegium, second quarter commercialization revenues of $31 million, were right in line with our strong first quarter revenues, of $30.9 million. As a reminder, early…

Thank you, Arthur. My comment this afternoon will focus primarily on our non-GAAP results unless otherwise noted. Today I'll review the financial highlights from our second quarter and first six months of 2019, as well as our outlook for the remainder of the year. Consistent with our first quarter, our financial results in the second quarter demonstrate the achievements we made last year in restructuring our business to maintain our profitability and further demonstrate the progress we've made towards being able to grow our neurology franchise. Our neurology revenues for the second quarter and first six months were $26.1 million and $52.4 million, respectively. For the second quarter and first half this represents 1% growth versus the prior year. Overall, this result was on pace with but towards the low end of our previous full year guidance for low to mid single digit revenue growth. The first half performance was negatively impacted by unforeseen and material product returns. As a result we believe it is prudent to narrow our guidance for the full year neurology revenue growth to low single digit. I'll discuss the drivers of this guidance change in more detail while discussing our product-by-product results. Consistent with the prior quarter and prior year, weighted average wholesaler inventory days for the portfolio were 19. Gralise generated sales for the second quarter and first six months of $17.8 million and $31.1 million, respectively. The first half revenue growth of 8.5% was driven by a favorable mix shift towards commercial business where we recognize higher net selling prices as well as the true-up of prior accruals for the same dynamic. Prescription trends were down modestly year-over-year. However, we continue to be encouraged by the improvement in year-over-year trends and we did grow sequentially by just shy of 3% in the second…

Thanks, Dan. Mel, we'll now open up the call for questions please.

[Operator Instructions] We have the first question comes from the line of Scott Henry of Roth Capital. You may ask your question.

Thank you and good afternoon.

Hi, Scott.

First on cosyntropin, has there been any correspondence with the FDA since the last quarter? And I guess it would be West. But also should we expect any correspondence prior to the PDUFA date, or is it just kind of dark until the PDUFA date?

Yes. Scott. We continue to respond to questions provided by the FDA. And I would say we feel pretty good about how we'd be able to respond to them to date. And this is really questions that will be expected with the submission.

Okay. Thank you for the color. And then Q2 had a lot of kind of noise around Gralise Lazanda and CAMBIA. When we think about Q3, should it look kind of like Q1, or will there be a boost in Q3 sort of a snapback from some of the sales you lost or vice versa with Gralise? Will it -- should it weak in Q3 because of what happened in Q2? Just trying to get a sense of how we should think about the numbers going forward?

I think for Gralise you'll start to see the performance in back half look more like the first quarter in terms of absolute dollars. We expect volumes to come up, but at a lower net selling price than what we experienced in the first half. The snapback that we expect to see would be on Zipsor where that has just simply been weighed down by those product returns that we have been talking about. So we would expect to see that sales start to match the demand driven growth that we're experiencing. And then CAMBIA, I would expect the back half would more look like the average of the first half.

Okay. That's helpful. And then with regards to Zipsor could you give a little color about short-dated product returns and how that comes about and what exactly does that mean?

So what we experienced was there -- you typically see a larger amount of returns concentrate around the expiration date of a batch. And in the first and second quarter we had a series of batches that all expired right around the same time. And that last batch to expire some of that product, we'll ship with short dating in it i.e. less than 12 months of dating until the expiration date. And what we've learned is that you get outsized returns, if you are shipping it with shortened dating.

Okay. Great. Thank you for that color. And final question, I think, I saw there was a couple million in opioid-related expenses. Should we expect that to continue -- or litigation expenses I should say. Should we expect that to continue for a couple of quarters, or when does that kind of fade away?

I don't think you're going to see that fade away just the ongoing expenses as part of our defense in these cases in preparation for them. We're expecting about $10 million to $12 million in total expenses this year for that.

Okay, great. Thank you for that color. And thank you for taking the questions.

Thanks Scott. Operator, now we’ll take the next question, please.

Yes, sure. Next question comes from the line of David Amsellem of Piper Jaffray. Your line is open.

Hi, good afternoon. This is Mick Ingerman on for David. Thanks for taking the questions. So first on cosyntropin to the extent that you guys have discussed the issue of different PK profiles with the FDA, can you comment on what you're doing ahead of the October PDUFA date to address the issue?

Yes. We're continuing to walk with West to understand this issue. Again as I mentioned in my prepared remarks the significance of that is unclear.

Got it. Okay. And then assuming that everything goes according to plan and you guys get approval in October, can you shed some color on your expectations regarding payer access at launch?

Yes. We continue to have a positive dialogue with payers. And again there is an interest to obviously have a product like cosyntropin be available. And that interest has made it possible to have very constructive discussions with payers. Of course all of this is dependent on getting the product approved and when we're able to provide the products.

Got it. Thank you.

Okay. Mel, we're going to take another question.

[Operator Instructions]

Okay. Is that it?

I am showing no further questions at this time. I would now like to turn the conference back to Mr. John Thomas.

Okay. Thanks everyone for joining us this afternoon. A replay of the webcast and conference call will be available shortly and for the next 30 days. Please dial 1-855-859-3406 and use passcode 7769879. Please contact us or me if you have any follow-up questions or if we could assist you in any way. And as a reminder our earnings-related materials are all posted on the Investor Relations section of the Assertio website. Thanks for your interest today and have a good evening.

Ladies and gentlemen, this concludes today's conference. Thank you for participation and have a wonderful day. You may disconnect.