Arthur Higgins
Analyst · Mizuho. Mrs. Koffler, your line is open
Thank you, John. Good morning, and welcome, everyone. It’s my pleasure, firstly, to introduce and welcome our new Chief Financial Officer, Phil Donenberg. Phil comes to us after a successful tenure at AveXis, the local Chicago area gene therapy biotech, where he served as CFO and played a key role in the company’s almost $9 billion purchase by Novartis. Phil brings more than 20 years of leadership in finance, M&A and operations with most of his career focused in the specialty pharmaceutical and health care arena. I’m also joined today by Augie, our outgoing CFO, and this will be his final quarterly earnings call. On behalf of the Board of Directors, our executive leadership team and all our employees, I’d like to thank Augie for his service as CFO and his numerous contributions to our company over the last six years. As many of you know, Augie was instrumental in raising $1.2 billion of capital to support our growth and transition to a commercial-stage specialty pharmaceutical company. We wish him all the best in his next engagement in the Bay Area. I mentioned in our first quarter earnings conference call that I expected 2018 to be a very busy and productive year for our company. With more than half the year complete, I remain more confident than ever that this will indeed be the case. So I’d like to share with you some of our key achievements to date, as we continue to execute against our three-pillar strategy of maintain, grow and build. On maintain, we have de-risked our business through our agreement with Collegium while at the same time, significantly improving our profitability. On grow, we completed two new business agreements that will support future growth, our co-promotion agreement for Zipsor with Allegis and our in-licensing agreement with Applied Pharma Research for a new patient, family presentation of Cambia. And I’m pleased to report, in the second quarter, we stabilized our neurology franchise and showed the first quarter-over-quarter growth in total prescriptions for several years. On build, we remain on plan to file for cosyntropin depot by the year-end and have started patient recruitment in our infantile spasm trial, a devastating pediatric disorder. On the corporate front, we continue to demonstrate an ability to find ways to strengthen our balance sheet and accelerate our deleveraging. We recently announced we had received $20 million in cash from PDL BioPharma for the purchase of the remaining rights to the diabetes patents we sold to them in 2013. We also announced that we are in confidential settlement discussions with Purdue Pharma regarding ongoing patent litigation. If a settlement is reached, as is normal and customary, the settlement value will be some percentage of what we would possibly achieve, assuming we won the case in court. The expected cash from the potential Purdue settlement along with the cash from PDL will clearly strengthen our balance sheet and give us greater flexibility when it comes to a potential refinancing of our secured debt. Regarding adjusted EBITDA, today, we are raising our full year guidance from the previous guidance of $125 million to $135 million to $145 to $155 million. This adjustment reflects primarily the $20 million we received from PDL. Thus, we’re encouraged by our ability to show, for the first time in the second quarter, sequential prescription growth in our neurology portfolio. We still have more work to do, particularly with respect to Gralise. As a result, we are reducing our full year neurology revenue guidance from the previous guidance of $120 million to $125 million to $105 million to $110 million. We see this more as a timing issue, as it is taking us slightly longer to achieve our first goal of stabilizing the business before we can return it to sustainable growth. Importantly, we have been able to offset the sale shortfall through expense reductions. Let’s look now at our progress against our three-pillar strategy in more detail. Regarding our strategy to maintain, our Collegium agreement continues to help stabilize our business. As a reminder, under the terms of the agreement, Collegium records all revenues and assumes all responsibilities associated with the commercialization and distribution of both forms of NUCYNTA. Depomed received an upfront milestone from Collegium as well as guaranteed annual royalties of $135 million over the next four years on NUCYNTA sales. You’ll recall, we began booking these royalties as revenues in the first quarter of this year. In the second quarter, we received $33.75 million in cash and recognized $31.2 million in royalty revenue. So this agreement is working very well and as exactly as planned. Regarding our strategy to grow. With our neurology franchise, all three brands showed positive total prescription growth versus the first quarter, with both Cambia and Zipsor growing low double digits quarter-over-quarter. This is the first quarter in which all three products have shown sequential growth in total prescriptions for several years. Zipsor, in particular, stands to the benefits from our new co-promotion agreement with Allegis. However, overall, we still have more work to do and as I said, particularly with Gralise. The good news is that we believe we know what is necessary to return Gralise to growth. First, we are reducing our total call target universe from 7,000 to 6,000 physicians, so we can increase our call frequency on our key Gralise prescribers of which there are approximately 4,000 high-quality prescribers. Second, we have strong managed care coverage for Gralise with more than 75% of commercial lives covered. We need to make sure that we better leverage this coverage and along with a simple script program, we intend to ensure that more of the scripts physicians are writing get into the physician – get into the patient’s hands. Third, we have a differentiated product in Gralise. It’s combination of two once-daily dosing and favorable side effect profile. We need to communicate that in a more concise and proper manner. Let me now turn to our build pillar. I am particularly excited today to discuss our work in this area, because we have several initiatives that are just now coming into focus. And these will help shape the future of our organization at a time we’re also redefining our identity with a new company name and a renewed commitment to advancing patient care. With that in mind, let me spend a few minutes discussing our lead pipeline asset, synthetic cosyntropin depot. Cosyntropin depot is a long-acting, alcohol-free synthetic ACTH analogue that, we believe, if approved, will offer patients, physicians and payers an important treatment alternative in the United States. Before I discuss a specific regulatory approval strategy for cosyntropin depot, it’s important to understand the backdrop of the existing global ACTH market and the currently available products in the U.S. as well as outside of the U.S. There is only one long-acting market product available to patients in the U.S., and that is Achtar Gel, an animal-derived ACTH product marketed by Mallinckrodt that sold more than 1 billion in 2017. Achtar Gel was first approved in the U.S. in 1952. So for more than half a century, patients and physicians in the U.S. have had only one choice of a long-acting treatment. In addition, in more recent years, the cost of that treatment to the health care system has increased significantly, leading payers, patients and even the government and FDA to join the chorus of key stakeholders requesting a lower-cost alternative. We believe cosyntropin depot, which we intend to brand under the name, Synacthen depot, the same name used by Mallinckrodt in their commercialization of their synthetic cosyntropin outside of the U.S., can be that cost-effective alternative to Achtar Gel. And we’re confident that U.S. physicians will consider it a viable option based on global market preference. Outside the U.S., Synacthen depot is prescribed in many countries where physicians consider it the standard of care, given its established safety and efficacy profile. In addition, synthetic Synacthen depot has label indications that are generally recognized as similar to the animal-derived Achtar Gel. In fact, physicians well understand the similarities but appreciate the benefits of this being a synthetic product versus an animal-derived product. To that end, market research as well as analyst research shows that a significant number of physicians would prescribe a synthetic cosyntropin depot regardless of the product’s label or indications, if it were priced appropriately. Our own peer research indicates a similar level of receptivity to an alternative ACTH product, regardless of indication or label. So timeliness to the market is critical, especially as public pressure amounts for a long-acting ACTH alternative. Health care providers and payers are generally aware that Synacthen Depot sold by Mallinckrodt outside of the U.S. has similar clinical uses and a similar label to Achtar. They acknowledge this and have indicated they’re opening – open to considering using Synacthen Depot again if appropriately priced. Also, in May, the FDA Commissioner, Scott Gottlieb, announced the list of drugs that are off-patent but without any pending application for new competition. The FDA’s goal is to stimulate competition and help lower health care costs. Achtar Gel is on that list. There is clearly an emerging growing swell of demand for an alternative ACTH product in the U.S. The government wants it, peers want it, physicians want it, and most importantly, patients need it. By putting patients first, numerous stakeholders stand to benefit, and we plan to be there first. Our strategy to be first will seek us, look for approval for a diagnostic indication for suspected adrenocortical insufficiency. Pediatric and adult endocrinologists commonly use exogenous ACTH to trigger the body’s cortisol response, which helps determine if a patient’s adrenal and pitutary glands are functioning properly. Our goal is to demonstrate that the diagnostic performance of cosyntropin depot is comparable to the reference product, which is Cortrosyn. This will be a 505(b)(2) application that we remain on target to file by the year-end. In addition to our near-term filing plans with cosyntropin depot, we’re supporting the long-term development by evaluating issues as a treatment for important new orphan and special – specialty indications, such as infantile spasms, a devastating and rare pediatric disorder that usually begins in children before the age of 1. Enrollment and dosing in new trials to evaluate cosyntropin depot for the treatment of infantile spasms began in the second quarter. The indication has already received orphan status. As with the infantile spasm program, also partnering with medical experts, academic researchers and other thought leaders in definite therapeutic areas to refine our broader clinical plans for cosyntropin depot. So as you can see, cosyntropin depot represents a tangible near-term pipeline asset. We believe that our strategy to file first for the diagnostic indication is the most efficient and expeditious way to bring cosyntropin depot to patients in a timely manner. The last topic I’d like to briefly cover today is our upcoming name change and new corporate identity. Depomed is officially changing its name to Assertio Therapeutics, spelled A-S-S-E-R-T-I-O, Assertio. Again, the name is Assertio Therapeutics. The ticker symbol will be ASRT. We’ve timed the name change to coincide with the opening of our new corporate headquarters located in Lake Forest, Illinois, where we will be staffed and operational this month. We chose the Lake Forest location because it’s close in proximity to a number of pharmaceutical companies, and we believe this would make it easier to attract pharmaceutical talent. This has indeed been the case. Also, as we transformed the company, it became clear to us, the name Depomed no longer accurately reflected the business we are in today or the direction in which we’re headed or for that matter, the mission, values – and values that define us. On the other hand, Assertio reflects an aspirational mindset, consistent with our focus on advancing patient care. Our new branded entity speaks to as being assertive and decisive when it comes to our mission, vision, values and strategy and on our commitment to deliver shareholder value. It’s a new name and a renewed mission to advance patient care in our core areas of neurology, orphan and specialty medicines. I’m highly confident that we have the talented experience and energy within our organization to drive Assertio forward in a way that will benefit all stakeholders, including our shareholders. With that, I would now like to turn the call over to Augie to discuss the second quarter in greater detail. Augie?