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Text: On Slide 4 is our safe harbor statement.
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.
During today's call, management will make reference to non-GAAP financial measures, including organic sales growth, adjusted operating profit, adjusted operating profit margin, and adjusted diluted EPS.
Starting on Slide 5.
I am pleased to report that we had an exceptional first quarter.
This was driven by strong organic sales growth in both our base business and the accelerating demand for products associated with COVID-19.
Our high-value products continue to fuel increased gross and operating margins.
Together, this has resulted in record earnings per share for the first quarter.
The strength of our performance is demonstrated in our ability to execute the market-led strategy, leverage the power of our global manufacturing network, and rally as a One West team to meet the increased market demand.
I am proud of how our team members have focused on our priorities and emphasize the importance of our purpose and values during these times.
Turning to Slide 6.
We have highlighted the key drivers of growth in Q1.
We continue to see strong uptake of HVP components, including Westar, FluroTec, Envision, and NovaPure offerings, as well as Daikyo's Crystal Zenith.
Our biologics customers are seeking to use these best-in-industry components to ensure the highest degree of quality and safety for their vaccines and injectable medicines.
This has resulted in strong double-digit growth, excluding COVID sales, and continued demand growth for FluroTec and NovaPure in our biologics business.
Through the first four months of 2021, our participation rate in recently approved new molecular entities in the U.S. and Europe continues to be strong with over 95% of these approvals using either West or Daikyo components.
In addition, we experienced strong growth in Westar ready-to-use components with customers seeking the value, quality, and convenience of our Westar washed and sterilized products.
And for Envision, we also had significant growth with customers looking for higher quality and better production yields by using our Envision inspected components.
Another highlight was strong sales growth in Daikyo CZ syringes and vials.
Customers prefer CZ for its compatibility with their sensitive molecules and its outstanding track record of quality and reliability.
Moving to Slide 7.
The power of our global manufacturing network continues to support our growth trajectory.
We are uniquely positioned as a result of the global operations strategy implemented a few years ago.
This has enabled the right capabilities, scale, and flexibility to keep in pace with the increase in demand.
As a result of recent capital investments, we have expanded our manufacturing capacity across our high-value product portfolio with additional equipment and validated lines to support our highest HVP growth areas, Westar, FluroTec, and NovaPure.
We have accelerated the timeline for capacity builds within our existing footprint by working closely with our incumbent suppliers and staging installations around the 24/7 plant schedules.
Our first phase, which began at the start of the pandemic is about 75% installed and operational, with expected completion in second half of the year.
Our second phase, we'll see equipment arriving in the back end of the year in operational in 2022.
And we are evaluating additional investments for a third expansion phase in response to an increasing possibility of COVID-19 boosters and annual vaccinations required over the next few years.
When this occurs, we think that future COVID-19 vaccines could likely be fewer doses per vial and/or in single-dose prefilled syringes.
As a result, it may mean higher volume demand of our HVP components compared to what we are experiencing today.
I am pleased to share that from my recent visit to our Scottsdale, Arizona facility, we are on schedule with our fully automated line for CZ insert needle syringes.
We're in the process of validating the line, which is targeted to commence commercial production for our customers' committed orders during the third quarter of this year.
This is our third automated line with another line scheduled for delivery in late 2021.
Turning to Slide 8.
Core to our values at West has been a strong corporate citizen.
In 2019, we exceeded our initial five-year environmental, social, and governance, or ESG, initiatives set in 2017 and raised the bar higher with a new set of five-year goals.
I'm proud to say that we continue to make significant progress on our ESG priorities with good momentum toward our stated reduction goals for waste, energy, and water usage.
We continue to reaffirm our commitment to live by our One West team value that calls on us to respect each other, drive collaboration, and to embrace diversity, inclusion in our workplace.
And we continuously look for ways to improve sustainability of our business and the rigor of our ESG reporting continues to evolve.
Last year, we published a supplement -- or later this year, we will publish a supplement to our 2020 CR report incorporating the SASB ESG standards.
Let's review the numbers in more detail.
We'll first look at Q1 2021 revenues and profits, where we saw continued strong sales and earnings per share growth, led by strong revenue performance, primarily in our biologics, pharma, and generic market units.
I will take you through the margin growth we saw in the quarter, as well as some balance sheet takeaways.
And finally, we will provide an update to our 2021 guidance.
Our financial results are summarized on Slide 9, and the reconciliation of non-U.S. GAAP measures are described in Slides 17 to 20.
We recorded net sales of $670.7 million representing organic sales growth of 31.1%.
COVID-related net revenues are estimated to have been approximately $102.9 million in the quarter.
These net revenues include our assessment of components associated with vaccines, treatment, and diagnosis of COVID-19 patients, offset by lower sales to customers affected by lower volumes due to the pandemic.
Looking at Slide 10.
Proprietary products sales grew organically by 39.6% in the quarter.
High-value products, which made up more than 70% of proprietary products sales in the quarter grew double digits and had solid momentum across all market units throughout Q1.
Looking at the performance of the market units, Biologics market unit delivered strong double-digit growth.
We continue to work with many biotech and biopharma customers who are using West and Daikyo high-value product offerings.
The generics market unit also experienced strong double-digit growth led by sales of FluroTec components.
Our pharma market unit saw strong double-digit growth with sales led by high-value products including Westar and FluroTec components.
And contract manufacturing had mid-single-digit organic sales growth for the first quarter, led once again by sales of diagnostic and healthcare-related injection devices.
We continue to see improvement in gross profit.
We recorded $271.9 million in gross profit, $104.9 million or 62.8% above Q1 of last year.
And our gross profit margin of 40.5% was a 650-basis-point expansion from the same period last year.
We saw improvements in adjusted operating profit with $179.2 million recorded this quarter, compared to $88 million in the same period last year, for a 103.6% increase.
Our adjusted operating profit margin of 26.7% was an 880-basis-point increase from the same period last year.
Finally, adjusted diluted earnings per share grew 103% for Q1.
Excluding stock-based compensation tax benefit of $0.15 in Q1, earnings per share grew by approximately 102%.
So let's review the growth drivers in both revenue and profit.
On Slide 11, we show the contributions to sales growth in the quarter.
Volume and mix contributed $146.7 million or 29.8 percentage points of growth, including approximately $102.9 million of volume driven by COVID-19-related net demand.
Sales price increases contributed $6 million or 1.2 percentage points of growth, and changes in foreign currency exchange rates increased sales by $26.5 million or an increase of 5.4 percentage points.
Looking at margin performance.
Slide 12 shows our consolidated gross profit margin of 40.5% for Q1 2021, up from 34% in Q1 2020.
Proprietary products first-quarter gross profit margin of 46.3% was 610 basis points above the margin achieved in the first quarter of 2020.
The key drivers for the continued improvement in proprietary products gross profit margin were favorable mix of products sold driven by growth in high-value products, production efficiencies, one-time fees associated with certain canceled COVID supply agreements of approximately $11.8 million, and sales price increases, partially offset by increased overhead costs, inclusive of compensation.
Contract manufacturing first-quarter profit gross margin of 15.7% was 140 basis points above the margin achieved in the first quarter of 2020.
This is a result of improved efficiencies and plant utilization.
Now, let's look at our balance sheet and review how we've done in terms of generating more cash for the business.
On Slide 13, we have listed some key cash flow metrics.
Operating cash flow was $88.7 million for the first quarter of 2021, an increase of $31.6 million compared to the same period last year or a 55.3% increase.
Our first-quarter 2021 capital spending was $54.7 million, $22.6 million higher than the same period last year and in line with guidance.
Working capital of $844.2 million at March 31, 2021, declined slightly by $26.1 million from December 31, 2020.
Our cash balance at March 31 of $483.7 million was $131.8 million less than our December 2020 balance primarily due to our share repurchase program activity offset by the positive operating results.
Slide 14 provides a high-level summary.
Full-year 2021 net sales are expected to be in a range of $2.63 billion and $2.655 billion, compared to prior guidance range of $2.5 billion and $2.525 billion.
This guidance includes estimated net COVID incremental revenues of approximately $345 million.
There is an estimated benefit of $75 million based on current foreign exchange rates.
We expect organic sales growth to be approximately 19% to 20%.
We expect our full-year 2021 adjusted diluted earnings per share guidance to be in a range of $6.95 to $7.10, compared to a prior range of $6 to $6.15.
We continue to expand our HVP manufacturing capacity at our existing sites to meet anticipated core growth and COVID vaccine demand.
We are keeping our capex guidance at $230 million to $240 million but continue to evaluate the levels needed to support our continued growth.
There are some key elements I want to bring your attention to as you review our guidance.
Estimated FX benefit on earnings per share has an impact of approximately $0.23 based on current foreign currency exchange rates.
And our guidance excludes future tax benefits from stock-based compensation.
So to summarize the key takeaways for the first quarter, strong top-line growth in proprietary, gross profit margin improvement, growth in operating profit margin, growth in adjusted diluted EPS, and growth in operating and free cash flow, delivering in line with our pillars of execute, innovate, and grow.
To summarize on Slide 15, in this dynamic changing environment, we remain committed to our customers and the patients we serve together.
Our focus remains within the strategic pillars, which allow us to be more responsive, leverage our assets more effectively and support the trends that are happening in the industry today.
We're working from a position of strength, and we believe we have a long horizon of continued organic sales growth and margin expansion.
Today, more than ever, we're enabling our customers' ability to support patient health, and it's not taken for granted.
West products are needed by patients across the globe and in many cases, for the administration of life-saving medicines.
As the market leader, we know that West will continue to play an integral role with our customers as they develop and bring new medicines to market for a brighter future.
Stephanie, we're ready to take questions.

user
sees fy sales $2.63 billion to $2.655 billion.
q1 sales rose 36.5 percent to $670.7 million.
west pharmaceutical services - raising full-year 2021 adjusted-diluted earnings per share guidance to a new range of $6.95 to $7.10.

assistant