Nick Colangelo
Analyst · Ryan Zimmerman with BTIG
Thanks Gerard, and good morning everyone. In light of the ongoing COVID-19 pandemic, we're very pleased with our second quarter results, which exceeded our base case scenario from April across several measures including revenue, profitability, and cash utilization. Total net product revenues for the second quarter were $20 million including approximately $15 million of MACI net revenue, and $5 million of Epicel net revenue. As we'll discuss in more detail, we saw a very strong recovery as the quarter progressed, and COVID-19 restrictions on elective surgeries were lifted across the country. Total revenues which decreased 23% for the quarter, declined approximately 78% in April and 32% in May, compared to the same periods in 2019, and increased approximately 29% in June compared to June of 2019. Beginning in March, we implemented several measures to ensure that we maintained our near and long term growth opportunities, and that we were in a strong position when we emerged from the initial COVID-19 restrictions. In addition to continuing to manufacture MACI and Epicel and provide case support to surgeons and patients, we also implemented appropriate reductions in discretionary spending across the organization and deferred non-essential capital expenditures. These actions allowed us to partially offset the decrease in revenue, thereby minimizing the impact on profitability, and importantly allowed us to keep our talented workforce intact to ensure that we maintain operational readiness for what turned out to be a more rapid recovery and elective surgeries than originally anticipated. The reductions in expenditures together with a significant accounts receivable balance entering the quarter allowed us to minimize cash utilization. We ended the second quarter with approximately $81 million in cash and investments and no debt, compared to $79 million at the end of 2019. So all in all, we were able to deliver a solid financial performance for the second quarter in the midst of a very challenging environment. In terms of product performance, MACI had a strong recovery in the quarter in terms of both implants and importantly, biopsies, a leading indicator of future growth. We estimate that only about 10% of elective surgical capacity was available in April, with approximately 60% available in May, and 80% available in June. MACI implant biopsy volumes generally followed the available surgical capacity in April and May, but we saw a strong rebound in implants and biopsies in June. MACI implants which declined approximately 84% in April and 37% in May, compared to the same periods in 2019, increased approximately 21% in June. Based on our historical biopsy conversion rates, we estimate that about a third of MACI volume in June was catch-up of deferred cases, while two-thirds of the business was from normal patient flow. Overall, we estimate that nearly 50% of national surgical capacity was offline in the second quarter, and 25% was offline in the first half of the year. Yet, MACI revenue declined only 27% in the second quarter and 5% in the first half of the year. Likewise, while MACI biopsies declined approximately 79% in April, and 22% in May, compared to the same periods in 2019, biopsies increased approximately 23% in June. And the growth in biopsies that we saw in June continued through July. We believe that this strong recovery for MACI and outperformance versus available surgical capacity demonstrates not only the strong underlying demand for MACI, but that for a number of reasons, MACI is well positioned to resume its growth trajectory despite the current COVID-19 headwinds. First, MACI procedures are performed on an outpatient basis over 95% of the time in either a hospital outpatient surgery center or an ambulatory surgical center. So we don't expect MACI to be significantly impacted by restrictions focused on procedures that utilized inpatient hospital beds. MACI patients are typically young, active and otherwise healthy individuals who are less likely to have risk factors associated with COVID-19. And given the symptomatic nature of their injuries including chronic pain and loss of function, we believe that they are far less likely to defer treatment compared to patients for other orthopedics procedures. MACI also has a favorable reimbursement profile for both surgeons and facilities. And finally, despite any restrictions on procedures, our case management team is generally able to maintain normal functionality and work with surgeon offices and patients to move cases through the pipeline and schedule or reschedule cases in a timely manner. In terms of refilling the pipeline, the recovery and biopsies also demonstrates the strong underlying demand for MACI. Importantly, we continue to receive biopsies from new surgeons in the second quarter. While the absolute number of biopsy surgeons declined in line with biopsy volume, the proportion of biopsies received from new surgeons remained relatively steady. And as I mentioned earlier, the growth and biopsies that we saw in June continued through July. We also saw a strong recovery for Epicel in the back half of the second quarter. Epicel graph volume, which declined to 70% in April increased approximately 20% in May through June, compared to the same period in 2019. And Epicel biopsies increased approximately 6% in the second quarter, compared to the second quarter of 2019. Overall, Epicel revenue declined 7% for the quarter, but remains up 8% year-to-date. Finally, we announced on June 30, that the Biologics License Application for NexoBrid for the treatment of severe thermal burns was submitted to the FDA. Assuming a standard review cycle, we'd expect marketing approval for NexoBrid in June, 2021. We're excited for the opportunity to bring NexoBrid to the U.S. market, as we believe that it will change the standard of care for patients with severe burns, and will significantly expand the addressable market for our burn care franchise. I'd like to take a moment now to thank all of our employees for their dedication and efforts in serving our patients and delivering a strong commercial and operational performance in the second quarter, and for achieving the NexoBrid BLA submission ahead of our internal timeline in the midst of very difficult circumstances. Looking ahead, while the ongoing uncertainties related to COVID-19 preclude us from providing full-year guidance, we're confident in fundamental prospects of our business. And I'll now share some perspective on our expectations for the third quarter and Gerard will provide additional details in a moment. First, we expect MACI revenue growth in the third quarter of this year over the third quarter of 2019. Despite renewed restrictions on elective surgeries being implemented in certain states and regions of the country, to date, we've not seen a decline in biopsy or implant activity that would suggest any significant postponement of surgeries in those areas. Many of these restrictions pertain only to inpatient procedures that would utilize hospital beds overnight, and therefore generally do not apply to patients treated with MACI. For the reasons that I mentioned earlier, we believe that MACI is well positioned, and that MACI patients will be able to receive treatment even in areas with COVID-19 outbreaks. We also expect Epicel revenue in the third quarter to increase sequentially over the second quarter of 2020. And to return to recent historical quarterly revenue levels seen prior to the COVID-19 disruptions in the second quarter. COVID-19 has created certain challenges in terms of sales force access to burn centers, while representatives can gain access to support cases, there are restrictions on in-person sales calls get into high risk patient populations at those centers. These restrictions obviously could create some headwinds for near term growth as our ability to work through the sales process with new centers may be more limited. However, the team's doing a great job working through this challenge is demonstrated by the results in May and June and our stated expectations for the third quarter. Finally, we expect to recognize revenue in the third quarter in connection with MediWound’s first delivery of NexoBrid under the BARDA procurement contract, which is scheduled to take place later this quarter. I'll now turn the call over to Gerard to provide more detail on our second quarter financial results and additional details on our expectations moving into third quarter.