Mark Crossley
Analyst · Jefferies
Thank you, Shaun. Good morning, and good afternoon, everyone. I hope you and your families are staying safe and healthy through these very unique times. First, echoing Shaun's comments, we are incredibly grateful to our 800-plus employees that have quickly adapted to the challenging environment, demonstrating tremendous agility and working tirelessly for our patients. As you saw, our first quarter results were in line with our expectations and tracking well towards our original fiscal year 2020 guidance. However, as we entered March and the effects of COVID-19 began to impact the business, it became clear we are entering a potentially prolonged period of uncertainty. Shaun has already set out the organizational impacts on Indivior. In terms of the financial impacts, recall that around 80% of our net revenue is generated from the U.S. Here, the stay-at-home orders across the states are having unforeseen impacts on prescribers and patients for PERSERIS and SUBLOCADE. Based on the latest market research data from IQVIA, total interactions with health care practitioners are down approximately 70% and new-to-brand prescriptions are down around 40% compared with pre-COVID levels. New product launches, as I'm sure you've heard from other pharma companies, as well as medicines requiring direct HCP administration, have been especially impacted. Given the unknown duration and extent to these impacts, we're obligated to withdraw our fiscal year 2020 net revenue and net income guidance in April. Moving forward, our goal is clear: we manage the acute near-term impacts of the epidemic and mitigate enterprise risk, while also preserving the resources and capabilities that we believe will allow us to emerge successfully once the environment begins to normalize. Now turning to Q1 results where we saw a minimal impact from COVID. First quarter total net revenue was $153 million. The 36% decline versus Q1 last year was expected and mainly reflected the entry of generic film competition midway through the first quarter a year ago, along with termination of our authorized generic program. These dynamics were partially offset by higher net revenues from our new long-acting injectables. As in previous quarters, we saw a trend of higher-than-expected SUBOXONE Film market share retention in the U.S., continued good sequential SUBLOCADE growth and solid underlying performance in the Rest of World business. We also saw the overall growth of the U.S. buprenorphine market improved to low-teen rates from increased overall awareness of medication-assisted treatment and from the temporary improved access to treatment Shaun spoke to earlier. In terms of existing SUBLOCADE patients, we're seeing that the patients have received at least, that patients that have received at least 1 SUBLOCADE injection are repeating in line with the pre-COVID retention curves. This is encouraging and speaks to physician and patient satisfaction with treatment despite the logistics hurdles the pandemic may be presenting in the near term. As we described in our April business update, after acceleration in new patient enrollments for SUBLOCADE in January and February, we started to see the material drop-off in enrollments in line with the IQVIA industry data. The lower enrollment rate will, of course, impact the total number of potential SUBLOCADE units dispensed and, therefore, our overall net revenue potential, while the business is impacted by COVID-19. With the uncertainty on how the disease will progress, the timing and trajectory of the impact to our business is uncertain. Looking more closely at SUBOXONE Film, our year-end 2019 exit share was 24%, and our share through the month of April has been relatively stable at 21% to 22%. This performance is better than our expectations and we believe reflects a combination of factors that are likely short-lived. First, we had above-trend volume growth in the U.S. buprenorphine market in the quarter. Market growth in January and February was in line with our forecast rate of low double digits but began to increase in March, just after much of the U.S. adopted some form of social distancing. Recently, overall market growth trends have remained in the low to mid-teens, reflecting government actions to facilitate access to medication-assisted treatment that Shaun spoke to earlier. As we've consistently stated, we do not have strong quantitative basis to explain SUBOXONE Film's analog outperformance. And as such, we expect it to ultimately match observed industry analogs. Further, the sole focus of our U.S. commercial teams remains our approved depot technologies, SUBLOCADE and PERSERIS, as our sales force does not support the film. Turning to the Rest of World business. Last year, you will recall that we had a comparability item in the first quarter, which had the effect of depressing Q1 2019 net revenue. As such, there's a low basis for comparison when we consider Q1 2020 performance. On a like-for-like basis, performance for the Rest of World business had a low single-digit growth primarily driven by modest growth in Australia during the quarter. Looking next at margins. First, at the gross level. On an adjusted basis, performance of 90% reflects the shift in product mix post termination of the authorized generic program. Looking at the operated line, again, on an adjusted basis, we reported a modest operating profit. We had increased expenses from our promotional investments behind SUBLOCADE, including the national DTC campaign that we initiated in Q4 last year. And we continued to run through the first quarter. We also had higher legal costs in preparation for the DOJ trial that was scheduled to take place in May. And as you know, the trial has now been rescheduled to begin in late September. As we move forward, we expect the SG&A run rate to be lower with the DTC campaign not running post Q1, along with operating expense reductions that I would describe as purse-tightening, meaning reducing or ending nonessential expenditures, including benefits from less travel and entertainment during COVID-19 restrictions. Continuing down the income statement, we see a net finance expense versus net finance income last year as well as modest tax charge, all leading to a modest adjusted net loss. Now a quick snapshot of our borrowing position. Our liquidity remains strong with net cash of $674 million. The decline from the beginning of the year largely reflects the timing of government accounts payable related to rebate sought. These payables were partially offset by continued relative strength of SUBOXONE Film and increased net revenues from SUBLOCADE, which is subject to lower rebate rates. As you would expect, given the uncertain environment, we intend to maintain our focus on cash preservation. The borrowings under the term loan are not due to be repaid until December 2022. As Shaun said, we can pull additional levers, if necessary, to bolster our cash position, although we're not at that point. Additionally, we have not drawn on our $50 million revolver. Turning to the provision for which the vast majority is related to the DOJ matter. This increased to $621 million from $438 million. Of the $183 million increase, $494 million is classified as a noncurrent liability with the remaining $138 million classified as current. The new amount reflects the current status of the continuing matter. Of course, we continue to caution that the amount could be materially different, and we cannot quantify the ultimate cost of any settlement, but it could have a material impact on the group. To repeat Shaun's comment earlier and to preempt your questions, we're not able to provide additional color on continuing litigation matters beyond what's in the release. Lastly, on guidance, we're continuously monitoring and planning our business and we believe are effectively managing the short-term impacts of the pandemic while also ensuring we're able to emerge successfully as and when conditions normalize. Our immediate priorities are keeping our people safe, helping ensure we have adequate supply of our approved treatments across the globe. And protecting the business for all stakeholders. We will provide new guidance as soon as we're in a position to do so. With that, I'll turn it back to Shaun for closing comments.