Donald Morel
Analyst · CJS Securities
Thank you very much John, and good morning everyone. Welcome to this morning's call to review West’s fourth quarter and full-year results for 2011. Joining me today are Bill Federici, our Chief Financial Officer; and Mike Anderson, our Treasurer and primary investor relations contact.
Bill and I will refer to slides throughout our prepared remarks this morning which can be found on our website. The content of those slides is covered both in this morning's release and our commentary.
The fourth quarter results are summarized on slide 3. And I'll begin with the highlights shown on slide 4. We finished the year on a very strong note with revenues increasing 6.8% to $295.4 million on a consolidated basis, even with the unfavorable effects of currency.
Revenue growth was driven primarily by gains in the Packaging Systems segment, which grew 8.6%, with strong demand in Europe for our high value products such as Westar and Envision, which rose over 12%.
Our gross margin improved 0.7 percentage points compared with the fourth quarter of 2010. The improvement in gross margin was driven in large part by improved operating results in our contract packaging operations within the Delivery Systems division. Although helped by an improved sales mix and pricing actions to offset escalating raw material cost, the gross margin in the Packaging Systems segment declined slightly.
Our consolidated adjusted operating margin improved substantially by 2.4 percentage points resulting in adjusted diluted earnings per share of $0.59, an improvement of 40% versus the comparable period in 2010.
For the full year, revenues totaled $1.19 billion representing overall sales growth of 5.2% excluding currency impacts, and adjusted diluted earnings per share increased approximately 11% to $2.33 per share versus $2.10 for the prior year.
In the Packaging Systems segment, growth was strongest in Europe, South America and Asia and benefited from increased sales for diabetes products, value-added components and growth in emerging markets.
From an earnings viewpoint, the combination of pricing actions, an improving product mix, spending controls and main programs in our operations were able to mitigate to a large extent increases in raw material and overhead costs.
More importantly, the strong demand in our backlog and strengthening of committed orders we experienced in the second half of 2011 has carried forward into 2012. Within pharmaceutical packaging, globally, the current backlog stands at $282 million, up 16% from the same period last year.
We are optimistic about 2012 as many of the core business drivers we have previously discussed remain intact. Namely, we expect continued growth in systems for diabetes treatment, oncology, autoimmune disease and vaccines. In addition, several key customers have received marketing approval for new molecules, which incorporate less components and reconstitution systems.
As we begin the year, order patterns in the packaging segment remains strong and we expect to bring several new production lines into operation in our contract manufacturing segment during the second half of the year.
We believe the consolidated sales will grow between 4% and 7% at constant exchange rates to between $1.215 billion and $1.245 billion, with improvement in our gross margins to 29.6% versus 28.5% reported for the full year of 2011. R&D expense will increase by approximately $3 million as the CZ 1ml long syringe and SmartDose systems move towards commercialization and clinical trials respectively.
Our guidance does include $10 million to $15 million of new sales that we anticipate generating for these proprietary products under development. However the timing of these revenues is largely up to customer decision points in their internal product development plan. As a result, adjusted earnings at current exchange rate should fall between $2.37 and $2.55 per share.
Slide 5 provides some quick highlights of our ongoing expansion and product development program. The China rubber facility remains on schedule for completion at the end of 2012 and the startup operations in early 2013. Construction of the India facility is slated to begin in the second quarter and the expansion of our Kinston, North Carolina facility to accommodate growing demand for Westar and planned additions to our highlighted product line is well underway and should be completed by the end of the year.
Demand for Envision has been particularly strong as customers and regulators continue to push for lower and lower levels of particulate matter in finished dosage forms. In the second quarter, West will initiate the global launch of NovaPure, the next-generation closure system developed completely in accordance with the principles of quality by design as outlined in the FDA’s guidance on quality systems for good, current manufacturing practice regulations.
Products developed in accordance with these principles are based on more focused science-based decision making, with rigidly predefined quality and performance specifications which are then designed into the manufacturing processes for production. Initially, the NovaPure line will encompass small volume vial [ph] closures in addition to puncture components for prefilled syringes.
CZ sales for the year totaled $7.6 million, slightly short of our goal for the year and principally due to a delay in the availability of validated filling capacity to formal stability and line trial.
In November, West announced its collaboration with Vetter Pharma and the installation of a dedicated CZ filling line, which is fully validated and is capable of producing units formal stability testing.
Our expectation is that several customers will begin the process as growing stability samples over the coming weeks and months. We continue to see strong customer interest in the SmartDose system for large volume self-injections. And our efforts are now focused on validation of the CZ cartridge container so that those customers can begin the requisite stability studies as soon as possible.
We currently anticipate this will be in the second quarter. We also continue to feel the significant number of inquiries for custom CZ systems for delivered volumes in excess of 1 ml. We believe that those capabilities will help to eliminate the 1 ml upper limit for biologic drug formulations in current prefilled formats.
In our safety systems product line, we executed a new, 3-year supply agreement with a key customer for our Eris system, and expect to launch a new passive safety system in the second quarter. We have also secured 2 new programs with the Medimop Vial Adapter, representing 12 million to 14 million new units for 2012.
Overall, we finished 2011 on a strong note, with demand carrying into the New Year and remain focused on generating profitable growth from our strategic expansion and product development programs.
I'd now like to turn the call over to Bill Federici for a more detailed look at both our fourth quarter and full year results, along with our revenue and earnings guidance for 2012. Bill?