Eric Green
Analyst · Janney. Your line is open
Thank you, Quintin. Good morning and thank you for joining us today. This morning we reported our third quarter performance. We had solid sales growth in our Proprietary Product segment and another quarter of strong growth for Contract Manufacturing. We generated 13% growth in adjusted EPS, despite a difficult year-over-year comparison. Bernard will go over the detail later in the call. As we look to the remainder of the year, we expect that high-value product sales will continue to drive growth in the Proprietary Products segment, and as mentioned on past calls, we should see a moderation in contract manufacturing growth due to a strong fourth quarter last year with greater than normal tooling revenues. And Slide 4 shows our organic sales performance by quarter across both segments of our business. In the third quarter we had organic sales growth of 9.6% the highest level in the past two years. We had another outstanding performance in our Contract Manufacturing segment and our Proprietary Products statement grew high-single-digits despite softness in Biologics. Let me provide greater detail of the individual proprietary market units, starting with Biologics. The performance in Biologics was driven by two factors: first, as discussed on the last call we have a couple of customers that are working off of inventories that were built in preparation for drug launches, while others have made the decision to upgrade to a higher value product and need to work off their current product inventories. These are timing issues and we expect a return to a more typical ordering pattern through 2019 and anticipate stronger high-value product sales as a result; second, our self-injection delivery devices contributed to lower than expected commercial sales. As a supplier to drug companies our success is ultimately correlated with our customer's commercial success. We have a number of new development programs in the works and as they progress into commercialization, our growth will be associated with a more diverse group of drugs and that should lead to more consistent sales performance. That said, we continue to see growth with many customers who are purchasing high-value components for the new Biologic drugs. We know that customers are looking for high quality, reliable, and readily available solution to contain and deliver their large molecules. In this quarter we saw double-digit growth in high-value product categories such as Westar RS and RU and NovaPure. The fact that our overall business can offset softness in our Biologics unit and still generate 9.6% overall organic sales growth in Q3, is a testament to our robust product and service offerings and the diversity of our customers we serve. Our generics market unit grew mid-single-digits in the third quarter and is on track to finish the year strong. This growth is driven by volume and high-value product conversions and the long-term outlook is positive. We see growing interest in our AccelTRA Components Program. We have sampled more than 100 customers and secured our first commercial sales. The Pharma market unit grew strong double-digits. As a reminder, we believe the underlying Pharma market volume growth is in the low-single-digits. So the mid-teens growth we saw this past quarter is atypical. Driving this impressive result was a number of factors including, high-value product conversion success, increased adoption of our Vial2Bag product in the hospital setting, and a favorable year-over-year comp due to inventory destocking activity last year. In Pharma we expect to finish 2018 on the solid growth trajectory. Turning to Contract Manufacturing. We had another stellar quarter with 20% organic sales growth. This growth was driven by continued escalation of demand for diabetes-related diagnostics and drug delivery devices, which reflects strong patient demand in the market. As a result, we expanded capacity sooner than originally anticipated and we're seeing the results of that effort in our performance this year. We expect overall Contract Manufacturing sales in Q4 to remain around Q3 levels as we continue to address this increased demand. Turning to Slide 5, I want to give you an update on our self-injection delivery platforms SmartDose and SelfDose. With an FDA approval in two years of performance data in hand, we have proven that SmartDose is a viable delivery device for large volume and highly viscous drugs. We have two SmartDose customers commencing clinical trials. Multiple ongoing development projects, as well as several feasibility agreements that have recently been signed. Earlier this year, we had the first commercial launch of a drug used in the SelfDose patient controlled injector. We're pleased with the post-launch reception from customers which has resulted in increased development activities. We have learned a few lessons over the years, as we work to bring our self-injection delivery devices to market. First, customer interest for self-injection platforms continues to grow and feedback on our proprietary device technology to address this market needs has been well received. Second, the development cycle is long and regulatory hurdles are high. Our teams have demonstrated the ability to work with our customers to help them successfully, bring these innovative combination products through the regulatory approval process and into the hands of patients. And finally, long-term commercial success of our devices will depend on the commercial success for customer's drugs, fulfilling a diverse and broad customer base and product portfolio, which we're doing, is key to long-term success. We remain confident that along with the expansion of our component offering and administration systems, our device strategy will allow us to continue to meet the future needs of our customers. Turning to Slide 6. We announced at the two recent major Industry Conferences, the launch of our Integrated Solutions program. We have talked about how much complexity exists when bringing a combination product to the market. Our customers operate in highly regulated markets and the amount of testing and support services required to gain approval is challenging. At West, we have expertise that is unrivalled in the industry which can help our customers simplify the journey throughout the drug development cycle. We have bundled these services in a comprehensive offering that's complementary to our high-value product and device strategy. We have received positive feedback from our customers since our launch and look forward to bringing this Integrated Solutions program to our full customer base. With a solid Q3 behind us, we're reaffirming full-year 2018 guidance and are focused on finishing out the year strong by executing on our market led strategy. We are addressing our customers' unique needs with both our products and also with the services and technical expertise that West can deliver and our One West management system is driving improved gross margin and optimized capital spending in addition to delivering innovative manufacturing strategies that have led to better service to customers. We are early in our journey, but are confident that this global operational system will continue to yield benefit to West and to our stakeholders. Now I'll turn it over to our CFO, Bernard Birkett, who will provide more detail on the financial performance and our long-term outlook. Bernard?