Stefanie Cavanaugh
Analyst · Craig Hallum. Your line is open
Thank you, Todd, and good morning everyone. ESS sales increased to 46% to $6.9 million in the fourth quarter of 2018 versus $4.8 million in the fourth quarter of 2017. Sales in the United States increased 47% to $3.4 million; and outside the U.S., ESS sales increased 44% to $3.6 million. For the year, ESS product sales were 23.4 million, an increase of 42%. ESS growth have been achieved from both expanded proceedings within existing accounts and the existing new customers. Intragastric Balloon or IGB sales were $3.9 million in the fourth quarter versus $5 million in the fourth quarter of last year. Sales in international markets were roughly three quarters of our total IGB revenue in the fourth quarter and amounted to $2.9 million. This was a decline of 24%, compared to the fourth quarter of 2017, and was primarily due to lower sales to distributors. In direct market, ongoing market share gains in Europe, where we have available in the Orbera365 product were offset by declines in Brazil. In the United States, IGB sales declined approximately [$240,000] versus the fourth quarter of last year, or roughly 120 fewer balloons sold. This reduction is primarily due to continuing weakening market conditions that have persisted since the June 2018 FDA letter to healthcare professionals. In total, continuing product revenues for the fourth quarter of 2018 increased 10%, compared to the fourth quarter of 2017 with $10.8 million. Our GAAP fourth quarter revenue of $15.2 million included $4.1 million of surgical product sales, which we divested as announced on December 18. For the full-year, continuing product sales of $41.1 million increased 15%, while GAAP sales, which includes divested surgical product revenues declined 5% to $60.9 million. Gross margin for the fourth quarter 2018 was 46.6%, compared to 57.7% in the prior year period, and for the full-year 2018 gross margin was 54.5%, compared to 61.8% for 2017. There were two very distinct factors influencing our lower gross margin percentage this quarter; one of which is part of an ongoing trend, and one that is due to a deliberate effort on our part to bring down our finished goods inventory in the fourth quarter of this year. First, the ongoing trend is one we have spoken of often in the past, as our sales metrics shifted from the decline in surgical products with higher gross margins to Endo-bariatric products and especially to our ESS product line, which has a lower gross margin, our over gross margin has declined. Second, as we also have discussed in the past, we have been actively pursuing [three-named projects], aimed at improving our Endo-bariatric product gross margin over the past few years. In 2017, this was the transfer of the Helix from a contract manufacturer to our facility and in 2018, this was the transfer of the Cinch, as well as changes we made to various components of our IGB product. In preparation of these projects, in 2017 we increased our finished goods inventory to protect us in the event that the transfer products were delayed for some reason. With the completion in these projects, we took efforts to bring down our finished goods inventory in the fourth quarter. As our transitional risks have dissipated, we have lowered our finished goods from over 10 million at the end of 2017 to 5.8 million at the end of 2018, with approximately 3 million of this reduction occurring in the fourth quarter. And this was a favorable trend. However, it also means that more of our manufacturing overhead costs was charged to cost of goods sold in the fourth quarter than in other periods even though our fourth quarter manufacturing overhead spend is materially unchanged. Total operating expenses were $23.9 million for the fourth quarter 2018, compared to $15.2 million in the fourth quarter 2017. The largest contributor to this increase in operating expense was the loss on divestiture of the surgical product line of $7.8 million. Excluding this one-time loss, total operating expenses were 16.2 million, an increase of 6% or roughly 1 million over the fourth quarter of 2017. This increase was mainly due to higher research and development expenses resulting from higher clinical trial activities, new product development costs, and costs incurred in connection with our various gross margin improvement projects. For the full-year, excluding the loss on sale of the surgical product line, operating expenses for 2018 was 65.5 million, compared to 62.2 million for 2017, an increase of 5%, due primarily to higher research and development across all quarters of the unit. Our net loss for the fourth quarter of 2018 was $18.4 million, compared to $7.3 million for the fourth quarter of 2017. Excluding the loss on divestiture, our net loss would have been $10.6 million. Again, excluding the loss on divestiture from full-year results, net loss would have been $38 million, compared to $27.3 million in 2017. Along with our results, we announced in this morning’s press release that we closed our new senior secured credit facility with Solar Capital Limited. At closing, we borrowed 35 million, which was due to retire our prior credit facilities that would tend to mature in February 2020. After payoff and all associated transaction cost, the borrowings will increase our cash on hand $11.6 million. Additionally, the facility has the potential to be increased by another 15 million at the mutual agreement of our self and new vendor. The facility is also tailored to our restructured business. Whereby future financial covenants are exclusively based on our endo-product performance, and future payments we receive from the sale of our Surgical business can be used for general corporate purposes, while in our previous credit agreement these receipts were required to be used to pay down loan principal. Lastly, the credit agreement does not in include any warrant covenants. Our objectives for our refinancing were to fully refinance our existing debt. Second, to extend our cash run rate position. Third, be reflective of our restructured business. And fourth, to have minimal dilution. We think these objectives have been accomplished. And I will now turn it back to Todd.