West Pharmaceutical Services, Inc.

To ask a question during the session, you will need to press star 1-1 on your telephone. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Quinton Lai, Vice President of Investor Relations. Please go ahead.

Thank you, Gigi. Good morning, and welcome to West Third Quarter 2022 Conference Calls. We issued our financial results this morning, and the release has been posted in the investor section on the company's website located at westpharma.com. This morning, Eric Green and Bernard Burkett will review our financial results, provide an update on our business, provide an update on our financial outlook for the full year of 2022, and an introduction to a preliminary 2023 outlook. There is a slide presentation that accompanies today's call, and a copy of that presentation is available on the investor section of our website. On slide four is our safe harbor statement. Statements made by management on this call and in the accompanying presentation contain forward-looking statements within the meaning of U.S. federal securities law. These statements are based on our beliefs and assumptions, current expectations, estimates, and forecasts. The company's future results are influenced by many factors beyond the control of the company. Actual results could differ materially from past results, as well as those expressed or implied in any forward-looking statement made here. please refer to today's press release as well as any other disclosures made by the company regarding the risk to which it is subject, including our 10-K, 10-Q, and 8-K reports. During today's call, management will make reference to non-GAAP financial measures, including organic net sales, adjusted operating profit, adjusted operating profit margin, and adjusted diluted EPS. Reconciliations and limitations of the non-GAAP financial measures to the most comparable financial results prepared in conformity to GAAP are provided in this morning's earnings release. I now turn the call over to our CEO, Eric Green.

Thank you, Quentin, and good morning, everyone. Thanks for joining us today. We'll start on slide five. I'll begin by covering three main topics. First, examining the drivers of lower-than-expected Q3 results, Second, examining the impact of Q4. And third, providing color on our current view of market demand and projecting a preliminary sales outlook for 2023. Let's begin with Q3. As expected, we had a few drivers in the quarter that materialized. We had headwinds from FX. We had declining sales in contract manufacturing, and we had a decline in COVID-19-related sales of about $20 million from last year. If we exclude the headwinds from COVID, proprietary organic sales grew over 11%. However, this performance was below our expectations for the quarter. When we provided guidance on the Q2 earnings call, we projected that we would be able to shift resources formerly dedicated to pandemic-related production to other HVP products that are experiencing increased demand. Specifically, we plan to successfully address this transition by accelerating customer orders for NovaPeer plungers and fulfilling customer HVP orders originally requested for this year but pushed to 2023 because of longer lead times. These two factors were the underlying drivers to our guidance of strong double-digit-based organic net sales in Q3 and Q4. Instead, as the quarter progressed, we underestimated the complexity of the transition and were impacted with a series of setbacks related to capacity constraints and makeshift productivity. Much of our vaccine stoppers were going to fewer customers with fewer SKUs. This enabled high productivity and throughput with our HVP network. When transitioning to NovaPure plungers, we now are addressing demand coming from numerous customers, addressing drugs across numerous diseases and more SKUs. The end result is lower throughput through our existing HVP manufacturing sites. And compounding the situation further, as the quarter progressed, we had a reduction in capacity in our HVP operating network through a combination of equipment downtime and project delays related to the installation of HPP processing equipment. We estimate that the total negative impact to Q3 was $30 million. While we see these issues as temporary and expect full resolution in 2023, they will continue to impact us in Q4. As we look at the capacity constraints, we project that additional HVP processing capacity will come online early next year based on the timeline to install and validate the newer technology. Since we are already running at full capacity, we also are unable to address the additional demand coming from long lead time items in Q4. Altogether, while we still expect our base business, XCOVID, to grow more than 10% in Q4, we will not be able to offset the expected $80 million reduction in COVID-19 sales. While I'm disappointed that we're lowering our forecast for the rest of 2022, I want to stress that these issues are all supply-related and not demand-related. Moving to slide six. A robust order book of committed orders excluding declining COVID-19-related demand grew 20% year-over-year. Our customers have reiterated that they're looking to us to deliver the critical components and devices to address the growing injectable drug demand. And we have several customers that have notified us of potential upside demand, especially for Novapure plungers, beyond our current order book based on future drug launches. As we look at 2023, we are confident and expect most of the capacity issues will be resolved early in the year. Taking a reasonable view on capacity expansion and customer delivery timing, our preliminary look at 2023 includes the following projections. We now assume that COVID-19 sales will decline to a full year 2023 sales of approximately $90 million, or a 75% decline from 2022. This is based on current customer forecasts, which we believe assumes the continuation of current trends and COVID booster demand. We expect non-COVID-19 overall base business to grow in the double digits and in excess of our financial construct of 7% to 9%. Base proprietary products are expected to grow in the low teens led by biologics, and we expect CM sales to rebound to growth next year. Our participation rate in recently approved new molecular entities in the U.S. and Europe remains strong. Our components by West or our partner, Daikyo, are expected in almost all the biologics and biosimilars approved so far in 2022, and majority of small molecules approved. Adding it all together, our preliminary view is that we will have positive organic sales growth in 2023 despite an anticipated decline of approximately $280 million of COVID-19 sales. We will provide more detailed guidance on our Q4 call in February of next year. Now shifting to slide seven and some highlights from the quarter. I want to first thank our team members who continue to focus on our purpose to deliver superior value to customers through our high-quality products and solutions to make a meaningful difference to patients' lives. An example of this dedication and resiliency was evident in the recent response to the hurricanes that devastated Puerto Rico and Florida. Despite the personal impacts to our team members, they ensured their plants continued to produce and ship product with minimal impact. Just another great testimony to the strength of our One West team. We continue to make good strides with the opportunity to improve at-home management of diseases. I'm pleased to share that earlier this month, our customer, SC Pharmaceuticals, received FDA approval for Ferox-X delivered via on-body infuser, utilizing West's SmartDoty on-body drug delivery technology. This brings us to four FDA-approved drugs using our SmartDose technology. Our strategic collaboration with Corning is moving along. We anticipate that in Q1 2023, West's ReadyPak system with Valor glass vials, a ready-to-use sterile packaging system for use with NovaPure stoppers will be available to customers. Lastly, our WES experts are pleased to be back in person at recently held PDA conference and upcoming CPHI Worldwide showcasing our leadership with new scientific insights and technical developments across our portfolio of high quality drug delivery and devices. Moving to slide eight. With the capital spending investments initiated in 2020 for the larger capacity expansion, we continue to drive forward to complete the installation of our 2021 expansions and initiate the next tranche of investment earlier this year. You can see from the pictures how impressed with the ongoing expansions are across our sites. While they do not happen overnight, we are making good progress and expect all these investments will result in several billion units of increased capacity for our HVP components. Now I'll turn our call over to Bernard.