Rich Lindahl
Analyst · Jessica Fye from JPMorgan. Your question please
Thank you, Bob. Good afternoon, everyone, and thank you for joining the call. I'll start on Slide 9 with some summary thoughts. As you heard just now from Bob, while the business continues to make good progress towards our long-range strategic plan, our financial results for the second quarter were mixed. The core medical countermeasures, or MCM products, continue to perform well, are on track through the first half of the year and remain a strong foundational component of the Company. Importantly, our portfolio of medical countermeasure offerings is poised to expand with the anticipated closing of the acquisition of TEMBEXA, the oral antiviral smallpox treatment, and the collaboration with Ridgeback on Ebanga, the monoclonal antibody treatment for Ebola. Of note, our updated guidance for 2022 does not yet include the impact of either of these products. For the commercial products, we also delivered solid outcomes in the quarter driven principally by continued market demand for NARCAN nasal spray in the public interest, or PIP channel. Importantly, we expect the recent entrance of another generic product to increase competition in the PIP market, starting in the second half of this year, and our updated full year forecast reflects the anticipated impact. As for CDMO, it is important to keep in mind that we are still rebaselining this business as we transition back to a pre-COVID growth trajectory in line with our strategic plan. The second quarter's results as well as the updated 2022 full year CDMO forecast are informed by three primary factors. First, the wind down of our relationship with Janssen. As disclosed in our 8-K filings in June, we believe the contract entitles us to significant payment upon termination. While we continue to pursue resolution of this matter, given the uncertain timing of any potential future payment, our forecast does not assume any additional revenue, termination costs or contingent liabilities stemming from Janssen in 2022. Second, the expectation of limited production capacity at Camden in the short term as we focus on systems upgrades that reinforce our ongoing commitment to quality and compliance. And third, a transition to a post-COVID environment as COVID-related demand wanes in the current phase of the pandemic. Taken together, our performance this quarter once again demonstrates the importance of revenue diversification and reinforces the overall strength and durability of our products and services business model. With that, let's turn to the numbers. As indicated on Slides 10 and 11, highlights include total revenues of $243 million, a decrease over the prior year, driven primarily by a significant reduction in COVID-related CDMO revenues that was offset by a solid increase in product sales revenues. And as expected, our key profitability measures declined versus the prior year with adjusted EBITDA of negative $29 million and adjusted net loss of $43 million. Other notable items in the quarter include: Anthrax vaccine sales of $96 million, higher than the prior year due to timing of deliveries of AV7909 to the U.S. government's Strategic National Stockpile; nasal naloxone product sales of $102 million, slightly lower than the prior year and comprised of significant unit sales of branded NARCAN to U.S. public interest and Canadian customers as well as contributions from sales of the authorized generic product licensed to Sandoz. As expected, we continue to see lower branded NARCAN sales in the U.S. commercial retail market as a result of the generic launch late in the fourth quarter of last year. Other product sales were $40 million, higher than the prior year, driven primarily by deliveries to the U.S. government of VIGIV and deliveries of BAT to international customers. And to finish out the products discussion, note that there were zero ACAM revenues in the quarter. As has been the case for several years, we anticipate the next U.S. government option exercise and thus, the majority of this year's ACAM revenue will be realized in the second half. Turning to our Services segment. Combined CDMO service and lease revenues were negative $2 million, significantly lower than the prior year, driven by several factors. First, the reversal of $13 million of previously recognized revenues from the Janssen contract to align cumulative revenue recognized with cumulative cash collected. Next, in CDMO services revenues, the decline is largely due to lower combined revenues of $82 million from Janssen and AstraZeneca, reflecting reduced production activities at the Bayview facility for these two customers. The decrease also reflects limited capacity utilization at the Camden facility in the quarter driven by both the annual maintenance shutdown and activities to strengthen quality and compliance. These factors were partially offset by an increase in contracted manufacturing activities at the Winnipeg facility. And finally, in CDMO lease revenues, the substantial decline was primarily due to the completion in November 2021 of the Company's public-private partnership with BARDA in response to the COVID-19 pandemic. Turning to operating expenses. Cost of product sales in the quarter was $91 million, higher than the prior year due to the higher volume of product sales. Cost of CDMO was $79 million, significantly lower than the prior year due to reduced production across the CDMO network, partially offset by higher cost at the Winnipeg site, resulting from increased manufacturing activities during the period. R&D expense of $50 million, consistent with the prior year and reflecting our continued commitment to investments in pipeline programs intended to expand our product portfolio. And SG&A spend of $81 million, lower than the prior year due to reduced professional services and marketing costs, partially offset by higher compensation costs. Turning to additional financial information. Let's move to Slide 12 and review key CDMO performance metrics. As of June 30, our total customer count was 70, a decline one on a sequential basis. And in the second quarter, we secured new business of $16 million, all from existing customers and substantially all for non-COVID work. Next, please turn to Slide 13 for a review of segment performance during the quarter. As you know, on the first quarter call in April, we introduced segment reporting information by products and services using the two key metrics of revenue and adjusted gross margin to measure each segment's performance. In the Products segment, revenues were $237 million, an increase over the prior year, and adjusted gross margin was $148 million or 62%, both increases over the prior year, reflecting the impact of higher sales volume and product mix. As for the Services segment, revenues were negative $2 million, a substantial decrease from the prior year for the reasons just discussed. And adjusted gross margin was negative $81 million, reflecting the decline in production activities across our CDMO network. Moving to Slide 14, I'll touch on select balance sheet and cash flow highlights. We ended the second quarter in a strong liquidity position with $358 million in cash and available revolver capacity of just under $600 million. Our net debt position was $475 million, and net leverage remained modest at 1.3x. Our operating cash flow was negative for the quarter, and our investing and financing cash flows reflected our capital allocation priorities as follows: Second quarter capital expenditures were $32 million as we continue to invest in expanded capabilities and capacity to support our diversified products and services business lines. And in the second quarter, we repurchased approximately 700,000 shares at a cost of $23 million, pursuant to the $250 million repurchase authorization approved by our Board of Directors in November of last year. Cumulatively, as of June 30, we have spent $188 million of this authorization to repurchase 4.4 million shares. Please turn to Slides 15 and 16 for a review of our updated 2022 forecast and associated assumptions. As detailed in today's press release, we are resuming our guidance for the full year 2022 and have provided the following updated ranges. Total revenues of $1.15 billion to $1.25 billion; anthrax vaccine sales of $280 million to $300 million; nasal naloxone product sales of $300 million to $340 million; ACAM2000 sales of $225 million to $250 million; other product sales plus contract and grant revenues of $235 million to $240 million; CDMO revenues of $105 million to $125 million; adjusted net income of negative $15 million to positive $10 million; adjusted EBITDA of $80 million to $121 million; and gross margin of 41% to 45%. This full year 2022 forecast reflects the following key considerations: Medical countermeasure product revenues are consistent with our previous assumptions related to deliveries under existing U.S. government procurement contracts, including the assumed exercise of the ACAM2000 option. Nasal naloxone revenues reflect our most current assessment of the competitive dynamics, given our experience in the first half of the year, combined with the additional generic entrant in the second half of the year. CDMO revenues exclude any further contribution from Janssen. As discussed earlier, our forecast also assumes certain short-term limitations on production capacity at Camden as we focus on quality and compliance upgrades as well as the continued transition to non-COVID work across the network. Importantly, at the midpoint of $115 million, this updated level is a significant increase over 2019's CDMO revenue of $80 million, as we are benefiting from the operationalization of expanded capacity and capabilities at the Camden and Winnipeg sites. And as a reminder, the forecast does not include the impact of the pending acquisition of TEMBEXA or our collaboration with Ridgeback on Ebanga. Finally, we are forecasting total revenues for the third quarter of $230 million to $270 million. To conclude, please turn to Slide 17 for some summary comments. Our performance in the second quarter once again highlights the strength and durability of our diversified products and services business. We continue to see significant opportunity in our core medical countermeasure and growing commercial products segment, addressing the preparedness and response needs of governments, patients and other customers against a growing array of critical public health threats. We also see long-term potential for our CDMO offering, given our capacity and capabilities, coupled with the pace of innovation by our small- to medium-sized biopharma customers in this post-COVID era. Additionally, our R&D programs continue to progress. We are investing to strengthen quality and compliance across our entire site network. And we will continue to prudently allocate our capital in a combination of M&A and partnering transactions as well as focused capital investments while maintaining a strong financial position. We look forward to keeping you informed as we execute on these plans and deliver further proof points that demonstrate the long-term growth potential of our business. That completes my prepared remarks, and I'll now turn the call over to the operator so that we can start the question-and-answer session. Operator