Mark L. Baum
Analyst · Lake Street Capital Markets. Please go ahead
Good afternoon. And thanks for joining us on today's call. I would encourage you to review our fourth quarter and year-end 2021 earnings release, corporate presentation and letter to stockholders, all of which were posted on the Investor Relations section of our website just after the close of trading today. Before we take your questions, I'd like to provide some highlights of our results for the fourth quarter and year ended December 31, 2021, and give you a brief update on our operational progress. The fourth quarter of 2021 was yet another quarter of record performance, our sixth consecutive quarter of records in many key financial metrics, delivering a solid conclusion to 2021 and a springboard for 2022 and beyond. In the fourth quarter of 2021, Harrow reported record revenues of $20.2 million, and that was a 38% increase compared with $14.6 million reported for the same period in 2020 and an 8% increase over the sequential third quarter of 2021. Full year 2021 revenues grew 48% to $72.5 million, and that was from $48.9 million in 2020. Fourth quarter gross profit was a record $15.1 million, a 42% increase over gross profit for the year earlier period of $10.7 million and a 10% increase over the sequential third quarter of 2021. Full year 2021 gross profit came in at $54.3 million. That was a 58% increase compared with full year 2020 gross profit of $34.4 million. Gross margin for the fourth quarter of 2021 increased to 75% compared with the prior year's 73%, any sequential quarters, 74%. Gross margin for full year 2021 was 75% compared with 70% for full year 2020. Adjusted EBITDA was $4.6 million for the fourth quarter of 2021 compared with $4 million in the prior year period. That was a 16% year-over-year increase. Adjusted EBITDA for full year 2021 rose to $19.5 million, and that was compared with $5.7 million in the prior year period. On the operational front, our actions in 2021 were intensely focused on positioning Harrow Health to fulfill its vision of becoming a leading U.S. eye care company. For us, to execute on that vision, we are: one, focusing on ophthalmic surgical, chronic and acute care prescription pharmaceuticals; two, serving institutional customers. These are doctors and hospitals and ambulatory surgery centers; and three, continuing to add high-value FDA-approved products to our portfolio. We believe we made significant progress during 2021 and in the execution of our strategic plan, including increasing the cash on our balance sheet to record levels, which we accomplished without diluting our shareholders and completing several transformative transactions, all aimed at positioning us to move forward with the next steps in our strategic plan. In 2022, we are focused on building the infrastructure to support the significant growth that we anticipate over the next few years, beginning this year, not only from recent acquisitions of drug candidates like AMP-100 and MAQ-100, if they're approved by the FDA, but also from internally developed formulations that we expect to launch commercially over the next 18 months or so. Also, we continue to be on the hunt for additional M&A opportunities that could further increase our growth potential. In order to support this growth, we are expanding our existing commercial infrastructure, including adding eight experienced sales executives and a Head of Market access. We expect our team to be further expanded during 2022 as we prepare for the approval and launch of AMP-100 and the relaunch of IOPIDINE, MAXITROL and MOXEZA under our company umbrella. In addition, we are focused on strengthening our internal expertise and capabilities within regulatory compliance, quality and supply chain management. We are also in the process of establishing our own internal analytical lab, eliminating our reliance on third-party labs and enhancing our inventory management and self-distribution systems. This year is already shaping up to be a breakout year for Harrow. We continue to see strong daily revenues to this day. As we previously announced, October 16 of this year is our PDUFA date for AMP-100. And if approved, we intend to be ready a few months thereafter to launch AMP-100 into a market in which we have commercial credibility. That would be the U.S. ophthalmic surgical or procedure market. In addition, we expect to see value creation events from our noncontrolling equity positions in companies that were originally founded as Harrow Health subsidiaries before being deconsolidated. For example, in a few months, we expect Surface Opthalmics to report data on a major chronic dry eye study. This was the first study of its kind to ever go head-to-head against the two category-leading FDA-approved products, a big study. Soon thereafter, we expect Melt Pharmaceuticals to report top line data on its MELT-300 clinical study. As these events unfold, we will continue to grow our core ophthalmic pharmaceuticals business, launch new ophthalmic products we've been internally developing and review the potential for new accretive transactions in our area of focus. That's ophthalmic pharmaceuticals. Now let's take your questions. I'll pause to have our operator poll for questions. Operator?