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Text: I'm pleased to report another strong quarter led by record revenues at CooperVision, where we exceeded the high end of expectations for the quarter.
Our daily silicone hydrogel and myopia management portfolios posted strong results, and our key account strategy generated share gains in markets around the world.
Within CooperSurgical, our fertility business continued to perform extremely well, and we recently announced an exciting agreement to acquire Generate Life Sciences, a great strategic fit with our fertility and labor and delivery offerings.
For the full fiscal year 2021, I'm proud to report record revenues at both CooperVision and CooperSurgical, record non-GAAP earnings and record free cash flow.
As we enter fiscal 2022, we have strong momentum and expect another record-setting year.
Regarding fourth quarter results and reporting all percentages on a constant currency basis, consolidated revenues were $759 million, with CooperVision at $565 million, up 11%; and CooperSurgical at $194 million, up 11%.
Non-GAAP earnings per share were $3.28.
For CooperVision, our daily silicone hydrogel portfolio led the way, growing 19%.
All three regions reported strength in this product category, with our premium product, MyDay, and our mass market product, clariti, both performing really well.
Biofinity also had a solid quarter, supported by strength in toric multifocal.
For the regions, the Americas grew 6%, led by our daily silicone hydrogel lenses, with particular strength in MyDay, where we continue seeing strong fit activity.
EMEA grew a healthy 15%, with improving consumer activity and strength in our key accounts driving growth and share gains.
Within this region, we posted broad-based growth from our daily silicones and Biofinity.
Asia Pac grew 14%, led by a steady improvement in consumer activity and success with several new product launches.
This region remains a very important growth driver for us, and we're investing accordingly as we're outperforming the market and taking share.
For our FRP portfolio, Biofinity posted solid results, driving growth in markets around the world with its broad offerings, including the toric multifocal and Energys, the most innovative product in the monthly space.
Regarding product launches, we remain incredibly active.
I've highlighted in the past the many products and range extensions we've been launching around the world for MyDay, clarity, and Biofinity, and all that activity continued.
This has driven consistent share gains, and we expect that to continue.
One recent launch that I want to highlight this quarter is our new MyDay multifocal.
We've launched the product in the U.S. and several major European markets, and the feedback and results are absolutely fantastic.
We're consistently hearing from eye care practitioners that the new binocular progressive fitting system is a breakthrough approach that simplifies fit and provides optimal visual acuity at all levels.
And we're hearing that from patients who are touting it as the best multifocal they've ever worn for exceptional near, intermediate, and distant vision.
We expect this launch to continue performing extremely well and to provide a nice halo effect, supporting the already successful MyDay brand of torics and spheres.
Moving to myopia management.
Our portfolio grew 63% to $21 million, with MiSight up 165% to $7 million and Ortho K products up 40%.
We reached our goal of $65 million for the year, up 76% year over year, and our momentum is strong.
As a global leader in the myopia management space, our portfolio is the broadest in the industry, comprised of MiSight, the only FDA-approved myopia control product; our broad range of market-leading Ortho K lenses; and our innovative SightGlass Vision glasses.
Regarding MiSight, we didn't quite reach our target this quarter, but we did reach $19 million in sales for the full year, up a very impressive 149% year over year.
We're making great progress with independent optometrists, buying groups, and retailers around the world, and we're seeing momentum in all these channels.
We're also making great progress in China, where we signed an exclusive distribution agreement with Essilor.
Essilor is now actively promoting MiSight following a soft launch last month at one of the largest ophthalmic trade shows, and we're on target for a full launch in fiscal Q2.
We've also assembled an advisory board of key opinion leaders, whose affiliated hospitals represent over 50% of myopia management contact lens volume in China.
This team of experts is providing fantastic insight into our MiSight positioning and how we can grow Ortho K even faster and how SightGlass will successfully fit in.
As a reminder, childhood myopia rates in China are estimated at over 80%, and reducing myopia is a priority for the Chinese government, so the opportunity is significant.
Lastly, we recently presented our industry-leading seven-year clinical study of MiSight, confirming the product works for nearly all myopic children.
It cuts myopia progression by roughly 59% on average.
It works at any age a child starts treatment.
It works for as long as the child wears it.
And there's no rebound if treatment is stopped.
These are the drivers that will continue supporting short- and long-term growth.
Regarding our other myopia management products, our Ortho K portfolio performed really well, led by success in China.
And in November, we commercially co-launched our SightGlass myopia management glasses in Europe with Essilor, and we'll be partnering with them on several additional launches coming soon.
Overall, on myopia management, our momentum is strong, and we're still targeting constant currency growth of over 50% in fiscal 2022, to roughly $100 million in sales.
To conclude on Vision, we estimate the overall contact lens market grew 7% in calendar Q3, while CooperVision grew 8% even as new fits remain below pre-COVID levels.
data, roughly 64% of eye care practitioners stated they had capacity to serve more patients but cannot, mostly due to staffing challenges.
Having said that, trends are positive, and we expect the market to grow in the 4% to 6% range this coming year, supported by improving fit activity in the U.S. and EMEA and reopening activity in Asia Pac.
Meanwhile, the long-term macro growth trends remain solid, with roughly one-third of the world being myopic today and that expected to increase to 50% by 2050.
For CooperVision, we closed this fiscal year on a really strong note, exceeding the high end of our expectations, and we've entered fiscal 2022 with a robust product portfolio, new product launches, a fast-growing myopia management business, and strong fit data.
To ensure we're seizing the growth opportunities in front of us, we've increased our sales force investments, and we'll continue with our successful myopia management investment strategy.
We have strong momentum.
We're growing faster than the market, and we expect that to continue.
Our fertility business performed exceptionally well, growing 24% year over year to $82 million.
Strength was seen around the world and throughout our product portfolio, including from consumables, capital equipment, and genomics.
One particular area of continued strength was our RI Witness platform.
This is our proprietary automated lab management system that clinics implement to maximize safety and security by optimizing their lab practices.
A system like this is especially important in today's world to improve quality control and workflow management, to enable social distancing and prevent mistakes such as embryo mismatches, which you unfortunately occasionally hear about.
Regarding the broader fertility industry, our addressable market is approaching $2 billion, with 5% to 10% long-term growth expected.
It's estimated that one in eight couples has trouble getting pregnant due to a variety of factors, such as increasing maternal age, and that more than 100 million individuals worldwide suffer from infertility.
Given the improving access to treatments, increasing patient awareness, greater comfort discussing IVF, and increasing global disposable income, this industry should grow nicely for many years to come.
Within our office and surgical unit, we grew 3%.
Medical devices performed well, growing 20%, led by our portfolio of uterine manipulators, several of our surgical devices and our next-generation EndoSee Advance product line.
Meanwhile, PARAGARD declined 17%, largely as forecasted due to buy-in activity from last quarter's price increase.
Having said that, similar to what we've seen from the general IUD market, the performance was soft, likely due to COVID staffing challenges.
Lastly, for CooperSurgical, we recently announced an agreement to acquire Generate Life Sciences for $1.6 billion.
Many of you may know this company as a cord blood storage business, but they've done a phenomenal job expanding over the years, and this business is now a great strategic fit for CooperSurgical as they're a leader in donor egg and sperm and cryopreservation services for fertility treatments, as well as being a leader in cord blood and cord tissue storage, which is an excellent fit with our labor and delivery group.
Roughly one-third of the business is in fertility, which we estimate will grow 5% to 10% long-term, supported by general industry growth.
Meanwhile, combining Generate's offerings with our existing portfolio allows us to leverage our infrastructure, launch new products and go international to accelerate growth beyond this range.
Two-thirds of the business is in cord blood and cord tissue storage, which we expect to grow 3% to 5% long term.
This is driven by increasing demand for cord tissue stem cells due to optimism around the significant number of clinical trials using these stem cells for regenerative medicine.
Consolidated, this business offers long-term sustainable growth of 4% to 6%, and we believe there are opportunities to push that range higher with potential revenue synergies as we leverage our expertise.
To finish, let me make a few comments on fiscal 2022.
Introducing annual guidance in today's world is a challenge given COVID uncertainties.
Regardless, our organic revenue growth is strong, and we expect that to continue.
We're investing in product launches, and we're doing that intelligently by leveraging our operations to ensure we receive strong returns.
I believe CooperVision is the most innovative company in the contact lens space today, with leading products in myopia management and the broadest product offerings in the market, and CooperSurgical is in an extremely exciting position, led by our fertility business.
As a company, we remain on a steady upward trend, and we see that continuing for fiscal 2022 and many years beyond.
Fourth quarter consolidated revenues increased 11% year over year and also 11% in constant currency to $759 million.
Consolidated gross margin decreased year over year by 20 basis points to 67.5% driven primarily by currency, partially offset by lower manufacturing costs at CooperVision.
Operating expenses grew 16% as strategic investments in sales and marketing to support myopia management and fertility continued.
Within this, we did see slightly higher than initially forecasted investments for SightGlass Vision and MiSight in China, along with elevated distribution costs tied to higher demand of direct shipments.
Consolidated operating margins were 24.9%, down from 26.8% last year.
Interest expense was $5 million on lower average debt, and the effective tax rate was 10.3%, helped by stock option exercises in the quarter.
Non-GAAP earnings per share was $3.28, with roughly 49.9 million average shares outstanding.
FX negatively impacted us and was roughly $0.05 worse than expected when we gave guidance last quarter.
Free cash flow was solid at $110 million, comprised of $175 million of operating cash flow, offset by $65 million of capex.
Net debt decreased to $1.4 billion, and our adjusted leverage ratio improved to 1.38 times.
Moving to 2022 guidance and excluding the recently announced Generate Life Sciences acquisition, consolidated revenues are expected to be in the range of $3.032 billion to $3.090 billion, up 6% to 8% in constant currency, with CooperVision revenues between $2.225 billion and $2.267 billion, up 6% to 8% in constant currency, and CooperSurgical revenues between $807 million and $823 million, up 6% to 8% in constant currency.
Non-GAAP earnings per share is expected to range from $13.60 to $14, up 9.5% to 12.5% in constant currency.
And the tax rate is expected to be around 13%.
At the midpoint of guidance, this equates to constant currency revenue growth of roughly 7% and constant currency earnings per share growth of roughly 11%.
Regarding currency on a year-over-year basis, we're expecting an FX headwind of roughly 2.5% on revenues and 7% on EPS.
This impact will be most detrimental in Q1, where we're expecting earnings per share in the $3 to $3.10 range.
Before opening the call to questions, let me touch on the Generate Life Sciences acquisition that we announced on November 10.
As of today, we're optimistic we'll close in the next couple of weeks, which would give us roughly 10.5 months of their operations in our fiscal 2022.
Having said that, we're still waiting for final regulatory approvals, so we're not providing specific guidance today.
In the meantime, let me walk you through the deal accretion that we expect.
As previously announced, Generate has roughly $250 million in trailing 12-month revenue.
Gross margins are expected to be roughly 70%.
And opex is expected to be elevated in year one as synergies are expected to be minimal as we integrate and invest in the business.
As we are now closer to securing permanent financing for this transaction, we are updating our year one non-GAAP earnings per share accretion estimate to around $0.50 and would add that we expect this accretion to improve in year two with synergies.
In summary, we're pleased with how we closed this fiscal year.
And we look forward -- and as we look forward into 2022 and beyond, we continue to believe our strategic investments will drive top-line momentum, supporting share gains in both businesses and long-term sustainable earnings growth.

user
q4 non-gaap earnings per share $3.28.
q4 revenue rose 11 percent to $759.1 million.
initiating fiscal year 2022 guidance.
sees fiscal 2022 non-gaap diluted earnings per share $13.60 - $14.00.
fiscal year 2022 guidance does not include generate life sciences acquisition.

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