Categories Earnings Call Transcripts, Health Care

Catalent, inc (CTLT) Q4 2021 Earnings Call Transcript

CTLT Earnings Call - Final Transcript

Catalent, inc  (NYSE: CTLT) Q4 2021 earnings call dated Aug. 30, 2021.

Corporate Participants:

Paul Surdez — Vice President of Investor Relations

John Chiminski — Chair and Chief Executive Officer

Thomas Castellano — Senior Vice President and Chief Financial Officer

Analysts:

Tycho Peterson — J.P. Morgan — Analyst

Jacob Johnson — Stephens — Analyst

John Kreger — William Blair — Analyst

David Windley — Jefferies — Analyst

Michael Turits — KeyBank — Analyst

Sean Dodge — RBC — Analyst

Juan Avendano — Bank of America — Analyst

George Hill — Deutsche Bank — Analyst

Presentation:

Operator

Good day, and thank you for standing by. Welcome to the Catalent Inc. Fourth Quarter Fiscal Year 2021 Earnings Conference Call. [Operator Instructions]. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions].

I would now like to hand the conference over to your speaker today, Paul Surdez, Vice President of Investor Relations. Please go ahead sir.

Paul Surdez — Vice President of Investor Relations

Thank you, April. Good morning, everyone and thank you for joining us today to review Catalent’s fourth quarter and full fiscal year 2021 financial results. Joining me on the call today are John Chiminski, Chair and Chief Executive Officer; and Tom Castellano, Senior Vice President and Chief Financial Officer.

In addition to reviewing our fourth quarter and fiscal year 2021 earnings release issued earlier this morning, I also refer you to our other press release issued today, announcing our agreement to acquire Bettera Wellness, a leading developer and producer of gummy, soft chew and lozenges for nutraceutical, functional and botanical extract products.

Please see our agenda for today’s call on Slide 2 of our supplemental presentation, which is available on our Investor Relations website at investor.catalent.com. During our call today, management will be making forward-looking statements and refer to non-GAAP financial measures. It is possible actual results could differ from management’s expectations. We refer you to Slide 3 for more detail on forward-looking statements, Slides 4 and 5 discuss Catalent’s views of non-GAAP measures and our just issued earnings release provides reconciliations to the most directly comparable GAAP measures.

Please also refer to Catalent’s Annual Report on Form 10-K that will be filed with the SEC today for additional information on the risks and uncertainties that may bear on our operating results, performance and financial condition, including those related to the COVID-19 pandemic.

Now, I would like to turn the call over to John Chiminski whose remarks will cover Slide 6 through 13 of the presentation.

John Chiminski — Chair and Chief Executive Officer

Thanks, Paul, and welcome to the call. Fiscal 2021 was an extraordinary year for the entire world and for Catalent. During the year, we achieved truly significant results, financially, operationally and in terms of making a meaningful impact on our global community, including accelerating our capacity expansions and infrastructure, substantially expanding and deepening one of the best talent pools in the industry, intensifying our long-standing commitment to sustainable practices and accelerating our growth strategy, all while delivering record financial results.

We rose to the challenge of scaling our capacity to meet significant demand for vaccines and treatments to address the COVID-19 pandemic, and are on track to deliver well over 1 billion COVID-19 vaccine doses this calendar year. We’ve also continued to develop and manufacture a broad range of other important medicines under difficult, unprecedented and rapidly changing global conditions.

Our top priority throughout the pandemic has been to keep our employees safe, and we continue to be humbled by the dedication of the more than 17,000 members of our team around the world who have enabled us to grow the Company and deliver for our customers and their patients during this tumultuous time. Through our shared experience navigating the pandemic, we’ve grown as individuals and as a Company, added substantial new capabilities, and strengthened partnerships that together enhance our ability to continue to develop and deliver products that help people live better, healthier lives.

With that overview, I’ll now provide a summary of our financials for the fourth quarter and full fiscal year, as well as operational highlights since our last earnings call.

I’ll then conclude my prepared remarks with an overview of the acquisition of Bettera Wellness, which we announced this morning. Our net revenue for the fourth quarter was $1.19 billion increasing 25% as reported, or 22% in constant currency, compared to the fourth quarter of fiscal 2020. When excluding acquisitions as well as the divestiture of our blow-fill-seal business, which closed in March, organic growth was 26% measured in constant currency.

Our adjusted EBITDA of $348 million for the fourth quarter, increased 30% as reported or 27% in constant currency, compared to the fourth quarter of fiscal 2020 which includes organic growth of 32% measured in constant currency. Our adjusted net income for the fourth quarter was $209 million or $1.16 per diluted share, up from $0.90 per diluted share in the corresponding prior year period.

The Biologics segment given the continued high demand for drug product, drug substance and viral based offerings was again the top contributor to Catalent’s financial performance with organic revenue growth of 66% and segment EBITDA more than doubling from the fourth quarter of last year.

Our Softgel and Oral Technology segment continued to experience some of the same pandemic-related headwinds in the fourth quarter with net revenue down 1% over the fourth quarter of last year on a constant currency basis. However, margins improved year-over-year, and so is our outlook, as we’re seeing business gradually come back, and we expect to return to organic growth in fiscal 2022.

Our Oral and Specialty Delivery segment had organic net revenue growth in the mid-teens. After excluding the results due to the product in our respiratory platform that we voluntarily recalled last September, in OSD like SOT, we’re also seeing that certain offerings within that segment impacted by the pandemic are beginning to come back. And finally, our Clinical Supply Services segment posted over 20% constant currency net revenue growth and strong margin compared to the fourth quarter of fiscal 2020, a comparison period that included widespread disruption to clinical trials during global lock downs as a result of the pandemic.

For our full fiscal 2021, net revenue and adjusted EBITDA came in at record levels, driven by robust growth in our Biologics business, which represented 48% of our net revenue in the year. Fiscal 2021 net revenue was $4 billion, and constant currency organic growth was 25% compared to the prior fiscal year. We estimate approximately 18 percentage points or more than $550 million of our organic growth last year since July [Phonetic] from the net impact of the COVID-19 pandemic, after factoring in the amount of net revenue generated from COVID-19 projects, against opportunity costs and pandemic-related headwinds that were created in some of our service offerings.

Adjusted EBITDA exceeded $1 billion resulting in constant currency organic growth of 32% compared to fiscal 2020. We also increased our adjusted EBITDA margin to 25.5%, up 120 basis points from the 24.3% adjusted EBITDA margin in fiscal 2020. To meet our commitments to our customers and our patients, a number of Catalent facilities have been operating 24 hours a day, seven days a week for more than a year. At the same time, we’ve increased our workforce from 14,000 at the end of the last fiscal year to more than 17,000 today to meet our growing production volume.

As we said in past calls, COVID-19 has not only accelerated our strategic plans, but also accelerated returns on the strategic investments we’ve made, enabling us to put additional cash to work to continue to drive our long-term growth. Let me update you on some of these capacity and capability investments. As you know, our 950,000 square foot facility in Bloomington, Indiana plays a critical role in the global vaccine production effort.

Over the last year, we brought online two new vial filling lines, now dedicated to the manufacture of products for two of our COVID-19 vaccine customers. We’re also qualifying a high-speed syringe filling line at this site. This project was first announced in January 2019 and is expected to be operational in the next several months, in line with our original plan.

Given the strong demand for bio therapeutic manufacturing [Phonetic], we will continue to invest in digital drug product and drug substance capacity at our Bloomington campus. Our 300,000 square foot facility in Anagni, Italy also continues to make significant contributions to the global supply of COVID-19 vaccines for multiple customers. The additional high speed vial filling line we’ve accelerated for a vaccine customer is expected to be operational before the end of this calendar year.

Last month, we announced a $100 million expansion project at our Anagni facility, to add Biologics drug substance manufacturing capabilities to the site, establishing our first drug substance capacity outside of the US to support the growing European market demand for biologics manufacture and supply. The initial phase of the expansion includes installation of two 2,000-liter single-use bioreactors within new purpose-built manufacturing suites, associated investments to support clinical development and investments to support late stage and commercial tech transfers. This initial phase will also include the installation of all the needed infrastructure for further expansion in the future.

The initial bioreactors are expected to be operational for customer projects late in fiscal 2023. Later phases of the plant expansion contemplate creating 16,000 liters of total flexible manufacturing capacity, enabling 2,000 liter to 8,000 liter batches. Also in Europe, we announced last summer further investment in a facility in Limoges, France to create a European center of excellence for clinical biologics formulation development and drug product fill/finish services. These investments are on track to be completed by the end of fiscal 2022.

The modernization of the 56,000 square foot facility includes the installation of a high-speed flexible line, capable of filling vials, syringes or cartridges under Isolator technology as well as enhancements to its analytical and quality control laboratories. Our new center of excellence in Limoges will strengthen Catalent Biologics’ global and European capacity and will also serve as a feeder for additional services at our Anagni and Brussels facilities.

Moving to our cell and gene therapy offerings, we continue to add both capabilities and related capacity. We entered the cell therapy market in February of 2020 and have rapidly build our infrastructure and capabilities. We recently completed the build-out of our GMP cell therapies suites in Houston, Texas and have begun manufacturing for clinical supply. We’re also progressing the build out of our commercial scale cell therapy manufacturing facility in Gosselies which is on track to open in late fiscal 2022. We also continue to identify inorganic opportunities to grow our cell and gene therapy platform.

Recently, we acquired RheinCell Therapeutics, a developer and manufacturer of GMP-grade human induced pluripotent stem cells or iPSCs. Importantly, iPSCs are an ethically sourced substitute for embryonic stem cell and have shown significant promise in regenerative medicine for a wide range of therapeutic indications. RheinCell expands our existing custom cell therapy process development, and manufacturing capabilities with proprietary GMP cell lines for iPSC based therapies and enables us to offer the building blocks to scale iPSC based cell therapies, while reducing the barriers cell therapy innovators would otherwise space [Phonetic] to gain entry into the clinic.

In February, we entered into the plasmid DNA market through the acquisition of Delphi Genetics, also located in Gosselies, now part of our European Cell Therapy Center of Excellence, together with the launch of Plasmid DNA development and manufacturing capability through an organic investment at our Rockville, Maryland facility. We’ve since further expanded our European Cell Therapy Center of Excellence on our Gosselies campus, with the acquisition of an additional 32,000 square foot facility. This facility provides us with a capacity for commercial scale plasmid DNA manufacturing up to 500-liter scale.

With the integration of plasmid DNA into our overall cell and gene therapy offerings, choosing Catalent will allow customers to derisk their supply chains and optimize their programs along the entire development pipeline. In gene therapy, viral vector manufacturing capacity continues to be in high demand for the growing number of gene therapy compounds, currently in the industry’s development pipeline as well as for manufacturing viral based COVID-19 vaccines.

In fiscal 2021, we completed the build out of commercial-scale manufacturing suites in the first building at our Maryland gene therapy campus. To meet the increasing demand we see, we’re now out to be [Phonetic] in the adjacent building to include at least five additional CGMP suites, a project that remains on track for completion by this time next year.

Before reviewing the Bettera acquisition, I’d like to highlight our expanding corporate responsibility and ESG commitments and the additional progress we’ve made since our last update. As a leader in the growing CDMO industry, we understand the need to demonstrate our shared commitment, sense of urgency and value in contributing to the long-term sustainability of the entire biopharma sector.

In June, I shared our long-term sustainability plans at the Biopharma CEO Investor Forum, and I encourage you to watch the presentation on our IR website. Since then, we formalized our commitment to the Science Based Target Initiative, joining our growing list of companies selling actionable, science-based greenhouse gas emission reduction targets to limit global warming. This commitment includes calculating and reducing direct and indirect emissions, even as the Company continues to evolve and grow.

One of our first actions after making this commitment was to ensure that the energy we purchase for all our sites in North America, South America and Europe as well as the majority of our sites in Asia is coming from renewable resources. As a result of our actions, 97% of our electricity usage across the enterprise is now procured from renewable energy sources such as wind, solar, hydro and biomass, an achievement that will contribute to our overall greenhouse gas reduction efforts.

We will incorporate our work on science-based targets into our annual ESG report for fiscal 2021 which we expect to publish in the third quarter of calendar 2022. While I’m very proud of the items I just mentioned, and the many other items that have become part of Catalent’s ESG progress over the last several years, there is still more work to do. For example, some of our top ESG goals for fiscal 2022 include continuing to improve employee diversity at all levels of the organization and meeting our commitment to be landfill free by the end of fiscal 2024.

Now on to Slide 9, we’re pleased to announce our agreement to acquire Bettera Wellness. We’ve been seeking the right opportunity to expand our participation in the nutraceuticals and nutritional supplements market for quite some time, leveraging the accelerated growth dynamics of the space. Bettera is a leading developer and manufacturer of consumer preferred gummy, soft chews and lozenges for nutraceutical, functional and botanical extract products. And they have four fit-for-purpose production facilities in the US.

There is no question that Bettera is one of the leading independent suppliers in this high growth, capacity constraint portion of the market. Within this space, Bettera is well known for its ability to partner with its customers to develop and manufacture a variety of high-quality delivery formats with differentiated flavors and superior consumer experience.

It’s clear to us that the specialized expertise that the team will be bringing on is unparalleled and Bettera’s customer relationships reflect that. The acquisition will enable Catalent, and specifically our Softgel and Oral Technologies or SOT segment to expand our substantial existing consumer health platform with the fastest growing wellness product offerings in this area and also expand our ready to market product library, as well as provide a variety of packaging options to meet customer needs.

We’re excited to have this opportunity to strengthen our partnerships with our customers across gummies, soft chews and lozenges going forward. As part of today’s announcement, we are also increasing our expectations for long-term revenue growth rate for our SOT segment from 3% to 5% to 6% to 8% given the strength of our advanced offerings and product libraries and supported by the significant growth contributions that we expect from Bettera.

Moving to the transaction details, we’ve agreed to acquire Bettera for $1 billion on a debt-free, cash free basis, and we expect to close the transaction within the first half of this fiscal year. Today, the Company generates approximately $150 million in sales at attractive margins, reflecting its premium offerings and is growing at over 20% annually. We expect similar growth over the next several years.

We plan to fund the acquisition with a combination of cash on hand, a partial drawdown of our revolving credit facility and potentially the issuance of new debt with the resulting net leverage ratio of approximately 3.1 times at close. Like in some of our other recent acquisitions, we expect significant deleveraging in the near to medium term following closing and expect to maintain ample firepower for further strategic M&A.

From an earnings perspective, we expect the acquisition to be accretive to ANI per share in the first year after close and significantly accretive thereafter. At Catalent, we pride ourselves in our ability to bring in new talent and capabilities and we’re looking forward to seamlessly integrating Bettera and welcoming its team of approximately 500 experienced and knowledgeable employees and formulators to Catalent. On the integration front, we’ve developed a detailed plan to support and accelerate Bettera’s in-flight growth plans, and have already identified work streams and leaders for integration.

Let me now share some additional capability information and market trends as covered in Slide 11. As I mentioned, we’ve been seeking the right entry point into the nutraceutical gummies, soft chews and lozenges market for some time. Importantly, Bettera is one of the few at-scale independent manufacturers in market today, and is a market leader across all three categories.

In addition to Bettera’s enhanced solutions from development to commercial manufacturing and packaging, Bettera has an extensive library of ready-to-market formulations to accelerate product launches for partner brands. Importantly, Bettera has the ability to produce gummy formulations with both gelatin and plant-based technologies with culture, halal, organic and other certifications. Bettera also produces soft chews and in particular, soft chews using a cold process, which is ideal for protecting heat sensitive ingredients.

Our consumer health customers are constantly asking Catalent for new formats in additions to our product library and specifically ask about gummies and other engaging formats for their nutritional supplement and nutraceutical product concepts. We view Bettera as an innovation engine for emerging, high-growth brands and we’re excited to begin working with our customers, in this area going forward.

One of the reasons we’re focused on investing in these areas is that we believe Bettera is at the intersection of macro consumer health trends, with Innovative Delivery Systems growing at roughly four times the pace of the traditional market. I would also note that about two-thirds of this capacity constrained market is outsourced today. While the market for traditional delivery systems remains large, the innovative segment’s recent explosive growth has increased its portion of the nutraceuticals market to close to $17 billion today, measured at the retail level, more than doubling its market size over the last five years.

And we expect Bettera to grow in excess of the innovative market as a whole in the near to medium future. Finally, on this subject, I want to emphasize at Catalent, we always have room to add leading, high growth premium CDMO franchises to our business. Bettera is the latest example in our tradition of high growth and earnings accretive strategic M&A, and we’re excited to begin working with Bettera’s employees and customers.

I’ll conclude my opening comments by saying that Catalent prides itself on the track record of successfully identifying, acquiring and integrating world-class businesses with leading manufacturing development capabilities. Over the last several years, we transformed our portfolio, expanding capacity and capabilities across our service offerings. We’re proud of the work we’ve accomplished.

Our future has never looked brighter. As I look across our entire portfolio, I note again that we remain on track to meet or beat our goal of achieving 50% of our 2024 net revenue from our Biologics segment. We continue to forecast long-term growth in that segment in the range of 10% to 15%. Based on our confidence in the growth we foresee across all of our segments, we’re raising our projected consolidated long-term net revenue growth rate to 8% to 10% from the previous 6% to 8%, which we expect will be coupled with continued EBITDA margin expansion.

We’re confident in our trajectory and believe our announcement today is a testament to how our employees and partners have helped Catalent position itself for continued long term growth. I’m now very happy to welcome Tom Castellano back to our earnings calls. As you know, Tom, previously served as the Company’s Investor Relations Officer through 2019, and was promoted on June 1st as CFO from his most recent role as Global, Vice President of Operational Finance. Welcome back, Tom.

Thomas Castellano — Senior Vice President and Chief Financial Officer

Thanks, John. I’ll begin this morning with a discussion on segment performance where commentary around segment growth will be in constant currency. I’ll start on Side 13 with Biologics, our largest business segment, which represented 48% of our net revenue in fiscal 2021 compared to 33% in fiscal 2020 and half of our net revenue in the fourth quarter compared to 38% in the fourth quarter of last year.

Biologics net revenue in Q4 of $603 million increased 66% compared to the fourth quarter of 2020, with segment EBITDA increasing 112% over the same period. All net revenue growth was essentially driven organically and EBITDA growth was slightly impacted by 1% due to cost associated with scaling and integrating the cell therapy and plasmid DNA acquisitions we closed in fiscal 2021.

The robust organic growth in our Biologics segment in the quarter was again driven by high demand across segment offerings including drug product, drug substance and viral vector manufacturing along with bioanalytical services. The increase was primarily driven by COVID-19 related projects, which continued to contribute to both development and commercial revenue growth. The segment’s EBITDA margin increased significantly year-on-year to just under 31%, compared to 24.3% in Q4 of last year, which is primarily attributable to increased capacity utilization and higher volumes manufactured.

In fiscal 2022, we expect the Biologics segment will continue to grow net revenue at a double-digit pace, while not near the 88% growth rate, the segment recorded in fiscal 2021. Please turn to Slide 14 which represents results from our Softgel and Oral technology segment. Softgel and Oral Technologies net revenue of $301 million decreased 1% compared to the fourth quarter of 2020 with segment’s EBITDA increasing 6% over the same period.

This slight decline in net revenue continued to be driven by reduced volume demand for certain prescription products as well as lower demand for consumer health products, particularly for cough, cold and over-the-counter pain relief products. However, over the last couple of months we have seen business begin to recover and expect to return to growth in fiscal 2022 as contemplated in our guidance. EBITDA margin in SOT grew 220 basis points over the fourth quarter of 2020 due to an increase in productivity and favorable product mix.

Slide 15 shows the results of our Oral and Specialty Delivery segment, which were again impacted by the voluntary recall of a single product in our respiratory platform in September 2020 that we have previously discussed. As previously reviewed, this product had notably strong sales in Q4 of last year, following its February 2020 launch, and also included a product participation component, creating difficult comparisons over the periods.

There was an additional $3 million in recall related cost recorded in the fourth quarter, bringing the total to $32 [Phonetic] million for the fiscal year. With that background, the OSD segment recorded net revenue of $186 million in the quarter, which was down 19% compared to the fourth quarter of fiscal 2020. Segment EBITDA was $63 million, a 29% decline over the fourth quarter of 2020.

When factoring out the net impact from the divestiture of our blow-fill-seal business, and the acquisition of Accorda’s spray drying facility in February, organic revenue declined 4% and segment EBITDA declined 11%. Further, if you back out the revenue from the recall product in the fourth quarter of fiscal 2020, the OSD segment would have shown mid-teens revenue growth this quarter, driven by growth in both commercial and development revenue.

The OSD segment’s fourth quarter results reflect continued momentum in our Zydis proprietary platform which grew nicely despite some lingering consumer health pandemic related headwinds. Each quarter we disclose our long cycle development revenue in the current year in order to provide additional insight into our long cycle segments which include Biologics, Softgel and Oral Technologies and Oral and Specialty Delivery. In the fourth quarter of 2021, we reported development revenue across both small and large molecule products of $538 million which is 51% above the development revenue recorded in the fourth quarter of fiscal 2020.

Development revenue which includes net revenue from certain COVID-19 related products approved for emergency use, represented 45% of our revenue in the fourth quarter compared to 37% in the comparable period in the prior year. The strong growth in our biologics business included growth from the manufacturer of COVID-19 vaccines and therapies approved for emergency use, were the biggest driver of these year-on-year changes.

In the fourth quarter, our development pipeline led to 47 new product introductions for a total of 139 in fiscal 2021. As shown on Slide 16, our Clinical Supply Services segment posted net revenue $105 million representing 21% growth over Q4 of 2020. This notable increase, while appropriately reflecting the many positive aspects that work in the segment, should also be understood in the context of the segment’s decreased performance in the fourth quarter of fiscal ’22 — 2020, when the distribution and packaging businesses were impacted by global lockdowns and clinical trial disruptions due to the pandemic.

Segment EBITDA was $31 million, a 35% increase compared to Q4 of fiscal 2020 and was driven by strong demand in our manufacturing and packaging and storage and distribution offerings. Segment EBITDA margin was 29%, up 252 basis points over the fourth quarter of last year. As of June 30th, 2021 backlog for the CSS segment was $501 million compared to $490 million at the end of last quarter and up 18% from June 30th, 2020. The segment recorded net new business wins of $119 million during the fourth quarter, a 14% increase compared to the fourth quarter of the prior year. The segment’s trailing 12-month book-to-bill ratio is 1.3 times.

Moving to Company-wide adjusted EBITDA on Slide 17, our fourth quarter adjusted EBITDA increased 30% to $348 million or 29.3% of net revenue, compared to 28.3% of net revenue in the fourth quarter of fiscal 2020. On a constant currency basis, our fourth quarter adjusted EBITDA increased 27% compared to the fourth quarter of fiscal 2020. As shown on Slide 18, fourth quarter adjusted net income was $209 million or $1.16 per diluted share compared to adjusted net income of $154 million or $0.90 per diluted share in the fourth quarter a year ago.

Slide 19 shows our debt related ratios and our capital allocation priorities. Our net leverage was 2.2 times at June 30th, compared to 2.3 times at March 31st. We expect the acquisition of Bettera to increase our net leverage ratio, possibly to this high or just slightly above our target ratio of three times in closing with funding acquisitions and deploying combination on the $967 [Phonetic] million cash on hand and other liquid assets that we are reporting as of June 30th, a partial drawdown of the more than $700 million of capacity, we are reporting as available as of June 30th, under our revolving credit facility and potentially, the issuance of new debt.

We will naturally delever from there, providing us with plenty of flexibility to continue to pursue organic and inorganic growth opportunities. As just noted, our cash and cash equivalents balance at June 30th, stood at $896 million and our marketable securities were $71 million, giving us liquid assets of $967 million compared to cash and cash equivalents of $953 million and no marketable securities as of June 30th, 2020.

Moving on, our capital expenditures totaled $686 million in fiscal 2021 or approximately 17% of net revenue. This is in line with our expectations as we accelerate our organic growth plans to meet customer demands and patient needs, and we expect our level of capital expenditures to remain elevated as a percentage of net revenue in fiscal 2022 when we expect that capex will be approximately 15% to 16% of 2022 net revenue.

Free cash flow in fiscal 2021 was negative $253 million despite the higher level of EBITDA generated in the last year. This was due to our increase in capex spending and the cost of pandemic related precautions such as increased inventory levels and other supply chain mitigation efforts as well as higher net receivables. In fiscal 2022, we expect to return to positive free cash flow as a result of our strong EBITDA growth and expected improvement in our working capital, despite continuing significant capex investments.

As a final note on the balance sheet, I want to call out the disclosure in our 10-K Annual Report we filed with the SEC later today. You will see that, as of June 30th, we had one large customer that represented 15% or $155 million of our net trade receivable balance. This is an unusually high concentration reflected at single point in time to the end of the fiscal year. I note that the customers significantly reduced this filings [Phonetic] on the date [Phonetic] following the quarter close, and the balance is now well below the 10% reporting threshold.

Now, we turn to our financial outlook for fiscal 2022, as outlined on Slide 20, which does not reflect the just announced and still pending acquisition of Bettera. We expect full year net revenue in the range of $4.3 billion to $4.5 billion, representing growth of 8% to 13% compared to fiscal 2021. FX is currently expected to have a minimal impact on our revenue growth, as the decline in Euro is offset against the increasing British pounds. We project that revenue from pre-existing M&A activity will negatively impact our growth rate by 1 percentage points to 2 percentage points as the divestiture of the BFS business more than offset the multiple smaller acquisitions completed in fiscal 2021.

We project organic revenue growth in each of our segments to be within or above the long-term growth range we have previously disclosed for each segment, leading to revenue growth at or above our new long-term revenue growth range of 8% to 10%. For full-year adjusted EBITDA, we expect the range of $1.13 billion to $1.20 billion, representing growth of 11% to 18% compared to fiscal 2021.

I would like to remind you of the seasonality nature of our business, where revenue and EBITDA generation is more weighted to the back half of the fiscal year. We expect full year adjusted net income to be $585 million to $650 million, representing growth of 7% to 18% compared to fiscal 2021. We also expect our fully diluted share count on a weighted average basis for fiscal 2022 to be in the range of 181 million to 183 million shares. This projection counts our Series A convertible preferred shares as this all were converted to common shares in accordance with their terms. We expect our consolidated effective tax rate to be between 23% and 25% for fiscal 2022.

Now I’d like to close with a few comments regarding the revenue contribution from our array of COVID-19 response products. First, all of that revenue is considered organic revenue. Second, we now expect particularly in the light of the need to produce vaccine booster shots and address the growth in variant forms that this revenue will have a multi-year duration. Third, as John said in his opening comments, our net COVID related revenue in fiscal 2021 totaled more than $550 million.

While we do not plan to disclose a forecast of growth related to COVID revenue in fiscal ’22, given the capacity we have dedicated to COVID-19 projects that we brought online in the last nine months, we do expect continued growth from our work related to COVID-19 projects. In addition, we now see innovative vaccines, particularly the newer gene based vaccine as a long-term strategic product area for Catalent given the substantial partnerships we have built in this space due to pandemic.

Operator, this concludes our prepared remarks and we’d now like to open the call for questions.

Questions and Answers:

Operator

[Operator Instructions]. And your first question comes from Tycho Peterson with J.P. Morgan.

Tycho Peterson — J.P. Morgan — Analyst

Hey, good morning. I’ll start with one on Bettera, you know, it looks like this is basically 100% over the counter. Is that correct? And then, can you maybe just talk about how much of this was just about broadening the portfolio or is there a chance you could leverage some of the technology into your kind of branded business as well?

John Chiminski — Chair and Chief Executive Officer

Yeah. So first of all, this is clearly in the nutraceutical and nutrition category. So there are no prescription products in there. And just as a reminder, and you know this well, Tycho that Catalent is a leading pharmaceutical services provider for both biopharmaceutical companies and consumer health. So we’ve always had incredibly strong consumer health franchises, if you go into any CVS or Walgreens and you know, just pursue [Phonetic] the aisles, you’re going to see Catalent, franchises that Catalent has from a Liqui-Gels standpoint as well as many other products that people don’t know are being manufactured at Catalent.

So this has always been somewhere between 20% or 30% of our overall softgel business, and has been absolutely terrific. We’ve been looking to get into this area, honestly for the last four to five years, and we’ve recognized it as an incredibly high growth area, and we believe given the know-how and expertise, we have from an overall gelatin standpoint, we thought that we might be able to do this organically. But the truth of the matter is, is there a significant know-how and capabilities, somewhat different from what we do in softgels that necessitated us to go out naturally, acquire one of the leading businesses in this overall area.

What we also watch [Phonetic] about it is that, given the strong relationships that we have with leading consumer health care companies that were already partnered with from — from a DMS standpoint that we’re going to be able to leverage those relationships. And then lastly, I will tell you is, this is a capacity-constrained area in high growth and what Catalent does, just like we did with Cook Pharmica, just like we did with Paragon, just like we’re doing in MaSTherCell in cell therapy area, Catalent is an operating company that does things to scale. So we acquire assets and we — given the fact that this is a capacity-constrained area, we really believe that we can grow this business into the leading manufacturer of this unique delivery platform. And honestly, the margins are incredibly attractive.

Tycho Peterson — J.P. Morgan — Analyst

Great, that’s helpful. And then on guidance, and the income, obviously, you’re not providing any guidance around COVID, I’m just curious though, the way [Indecipherable] is actually talking about the aggressive booster rollout plan starting next month. Is that kind of baked in, in the near-term outlook? And do you think the COVID tailwinds could be higher or in line or below what you saw in ’21? And then longer term, you’re not really kind of quantifying the EBITDA margin expansion, previously you talked about 8% to 11%. I’m just curious if you could give us any kind of directional color there. Thanks.

John Chiminski — Chair and Chief Executive Officer

Yeah, sure. So first of all, it’s becoming increasingly clear that COVID vaccines and also boosters are going to be part of the way forward here. Literally, we’re sitting with only 15% of the population of the world vaccinated and the variants coming out we see, as we noted in our — in our prepared remarks that vaccines are really going to become part of actually the core Catalent business. I would tell you that, all of the current contracts and take-or-pay and forecast that we have from our customers with regards to the vaccines are contemplated in our current guidance.

Obviously, there are situations where that could actually go up, it just depends upon what actually happens there. But all of the current information is currently baked into our overall guidance. So I’ll turn it over to Tom for the back half of your questions.

Thomas Castellano — Senior Vice President and Chief Financial Officer

Yeah, I agree with everything John said there, related to guidance. I would also add Tycho, you’re right, we didn’t specifically highlight long-term EBITDA growth rates, but did speak to the continued margin expansion we expect to see as you’ll remember, we mentioned working towards a 28% EBITDA margins for the business by 2024 we continued to believe that’s a good target and are on pace for that. And we’ll continue to see EBITDA growth rates in the long term exceeding that revenue growth with the 8% to 10% revenue outlook we put out there.

Tycho Peterson — J.P. Morgan — Analyst

Okay. That’s helpful. And then one last one before I hop off, cell and gene, you know, you highlighted a lot of capacity expansion in the RheinCell deal as well, just curious if you look at your portfolio, do you have what you need, do you still see gaps? And then, you talked in the past about favorable upfront economics, capacity reservation fees, given a lot of the capacity that’s going to be coming online, do you think that model still holds?

John Chiminski — Chair and Chief Executive Officer

So first of all, I would just say that the dynamics in the gene and cell therapy space continue to be extremely robust. I think over the last two years, we’ve really added critical pieces for our portfolio, in the cell therapy space giving additional manufacturing facilities and capacity, we entered into the plasmid DNA space, and now obviously with the acquisition of RheinCell, we have our hands on kind of iPSC cell bank.

So, we really think that we have a strong portfolio. But I will tell you that we have a very strong science and technology team that is forward-looking and continues to understand where the technology is going, and where Catalent can add additional, I would say technology and capabilities into its portfolio. And we’re going to continue to do that. I would say that, broadly speaking, in the Biologics area, it’s going to continue to take a large part of our overall growth capex for the Company, because we continue to see extremely strong pipelines, and in this business as we’ve seen over and over again, if you have the right capacity at the right time, you actually garner win that business.

Our gene therapy business is moving much more mainstream in terms of our making product to make EBITDA. And I would say that the reservation fees that we — that were a significant component of the early part of the business when we were literally dealing with a handful of suites within Catalent. Well, it will be somewhat part of the model, but it will not be the main part of the model.

The bottom line is, when we have capacity cuts, we were able to actually make the right deal in terms of what we would call site preparedness, equipment preparedness. And if a customer has long-term forecast from once suite from a certain period of time, we’re absolutely going to go ahead and get reservation fees. But I would say that that was much more of a model in the early days and now we’re moving towards a model of just making literally hundreds of batches in our gene therapy business. So now a lot of the money is flowing from purely the work that we’re doing which is pure reservation fees.

Tycho Peterson — J.P. Morgan — Analyst

Okay. Very helpful. Thank you.

Operator

Your next question is from Jacob Johnson with Stephens.

Jacob Johnson — Stephens — Analyst

Hey, thanks. Congrats on the quarter. Maybe just a similar question what Tycho just asked, but asking in a different way. The Bettera deal is a fairly significant deal to bolster the SOT segment after a variety of deals on the biologics side. I mean, is this a signal that you have the majority of the biologics capabilities you need at this point? So we should think about the investments being largely organic on that side of the business in the near-term?

John Chiminski — Chair and Chief Executive Officer

Well, clearly, I would say we’re always on the hunt for great biologics asset period. However, with the platform that we have basically built through acquisition and attitude from an organic standpoint, we really believe we have a footprint where organic investment is going to continue to fuel our growth. So in today’s earnings prepared remarks we talked about several significant expansions whether it’s in Anagni, whether it’s in Limoges, I will say there are significant capex projects going on all across Catalent, and obviously, we’re going to be seeing a high level of capex spend again this year. But Catalent really does continue to be very active in the M&A market. We do feel that we have really the right set of assets on the biologics front. And quite frankly, by being able to pivot here, open up really an exciting acquisition that’s going to bolster our SOT business segment from 3% to 5% to 6% to 8%, an incredibly attractive margins in a capacity constrained environment.

This is what Catalent does. We operate at scale. So Catalent’s ability to scale up that business and drive to be number one in this innovative delivery platform is really what we have our sights set on. So what I really do like about Catalent is it’s a well balanced business. And quite frankly, we’ve really been taxing pretty aggressively through the pandemic and the vaccines, our biologics and gene therapy segment. And now this allows us in our SOT segment and to some extent our other segments to be able to use our leadership to build out a part of the business that’s always been core, a critical platform, has paid the bills with cash flow for many, many years. Again, absolutely a terrific acquisition for us and we’re excited to have the Bettera team as part of Catalent with their expertise and know-how.

Thomas Castellano — Senior Vice President and Chief Financial Officer

And Jacob, I would only add to this one, just around the market profile, John said in his prepared remarks as well as here around the attractiveness of the margins for Bettera that they are actually accretive, not only to the SOT segment, but to Catalent overall. So very strong financial profile here of the entire business.

Jacob Johnson — Stephens — Analyst

Got it. Thanks for that, John and Tom. And then maybe just a follow-up on that. John, you mentioned Anagni, you’re adding drug substance capabilities there. You have both of the — both substance and product capabilities. Can you just talk about the synergies between having both those capabilities in a single campus?

John Chiminski — Chair and Chief Executive Officer

Yeah. No, it’s a very big deal. Thank you for pointing out Anagni. First of all, I just want to just say thanks to the Anagni leadership team. What they have done over the last 18 months has been absolutely phenomenal. And here in the U.S. we talk a lot about our Bloomington site, but the Anagni site has literally been a marquee site for the European COVID-19 vaccine efforts. And the team has really delivered flawlessly, literally more than 100 million vaccine doses that have come out of there. So just a terrific leadership team.

I can tell you that the synergy between drug substance and drug product is huge. Actually, we have an offering floor within Catalent, it’s called OneBio. And our ability to basically do cell-line engineering, do drug substance scale up into Phase 1 and then be able to put that into a finished drug dosage format for clinical trials and then ultimately scale up, the manufacturing is absolutely huge there. A relatively few non-CDMOs have that capability. Our biopharma customers, the large ones do. But from a CDMO standpoint, I think Catalent is really up there with only maybe one other CDMO that is able to have drug substance or drug product. And even better, if you can have it all in one campus, which is what we’ll be able to do at Anagni. So we kind of announced the 2×2000-liter, but we’re going to have the ability obviously to scale that up much more significantly. And I think you’re going to see Catalent becoming extremely strong player from a biologics drug substance and drug product standpoint.

Back to the previous question with regards to M&A in biologics, this is an area where we have some terrific assets between our Brussels facility, our Limoges facility, our Anagni facility where we’re investing from a drug product and now also drug substance standpoint. If we could secure additional drug substance and drug product assets in Europe, that would clearly be high in our priority list. And we have been participating in quite a few processes, but haven’t been able to land that one yet. So we’re clearly being aggressive on the overall organic drug. But back to the question, the synergies between drug substance, drug product and the OneBio offering we have which is bringing in more and more customer specifically with small to medium-sized customers who want to have one-stop shopping from this standpoint is very significant.

Jacob Johnson — Stephens — Analyst

Got it. Thanks for taking the questions.

John Chiminski — Chair and Chief Executive Officer

Thanks, Jacob.

Operator

Your next question is from John Kreger with William Blair.

John Chiminski — Chair and Chief Executive Officer

Hey, John.

John Kreger — William Blair — Analyst

Hey. A couple of the capex questions. John, you mentioned Bettera and that whole space is capacity constraint. How is the available capacity in that asset that you’re getting? Are you going to have to dedicate a fair amount of capex to keep up with the growth?

Jacob Johnson — Stephens — Analyst

Yeah. So first of all, Bettera really is in a massive growth phase, as we’ve stated. They’re growing at 20%. They have several in-flight capex investments. I’m sure at some point we’ll be talking on these calls about something called a mobile, which is really the work horse for the gummies area, and we will be investing additional capex to scale that business. But I will tell you that the capex levels of spend will be much lower than anything that we’ve seen from an overall biologics standpoint, lower than what we see from an overall Catalent standpoint. And we’ll probably be slightly higher, but more in line with what we’ve traditionally spent in our SOT segment, really making it again a strong cash generator at extremely attractive margins for the company.

John Kreger — William Blair — Analyst

Great. And then also, John, I think you told us that capex in the coming year should be 15% to 16% of revenue. Should we start to think about that as sort of the new normal for the company longer?

John Chiminski — Chair and Chief Executive Officer

No, no. Look, we have to sit back and remember that COVID was a massive accelerator for Catalent from a strategic standpoint. It actually accelerated our strategic plans and we brought on capacity earlier than we normally would have. And then that capacity post, let’s say, largest volumes of vaccines and three, maybe four years is going to be reapplied to the overall company. So I think we’re seeing here over the first couple of years obviously this accelerated capex spend. But as we kind of model out in our strategic plans, we see our capex spend moving much more towards that higher single-digits capex spend that we had prior to going into overall COVID, and I think that’s the right way to look at the overall business.

That being said, what we traditionally see is, again, Catalent is a company that buys high growth assets and then scales them up. And I will repeat, we are going to be working to be the number one provider in this gummy categories over time. So we take the assets and we invest in them to make them leading franchises. So if we were to not acquire anything else, I would see our capex moving down to that high-single-digit level. But again, as we acquire assets, we do invest in them. So we’ll really be dependent upon what assets we did, John. Whether or not that’s going to — we’ll see slightly elevated area. But again, we love these projects because the IRRs and cash on cash returns for the investments we are doing on the growth side, specifically in biologics, gene therapy and now in the gummy area is going to be pretty fantastic.

John Kreger — William Blair — Analyst

Sounds good. Thank you.

Operator

Your next question is from Dave Windley with Jefferies.

David Windley — Jefferies — Analyst

Hi. Thanks for taking my questions. John, I appreciate the emphasis you put on that answer to John. Capex intensity will come down. Good to know. I’m wondering on the longer term growth algo. I’m thinking about your biologics and COVID revenue within biologics and the hand off of that over the long-term. And is the extension of a booster market, does that makes that that much easier to manage that it’s not going to be sort of sudden, but rather a longer, more protracted hand off to other products in the long-term?

John Chiminski — Chair and Chief Executive Officer

Sure. So first of all, we did not see a COVID cliff in Catalent. We recently came out of our strategic plans and we modeled out, and this was in April. A lot of things have happened since then, but we’ve modeled out three different scenarios. And right now, I would tell you that our current modeling against expected case was actually higher given the fact that we see vaccines for COVID specifically being really much more of a sustaining and an enduring revenue for Catalent, specifically with the advent of boosters that will come out lowering the age of those vaccines plus the large part of the world that still needs to get vaccinated. We’re also seeing a change in formats where we want fewer doses per vial. We’re seeing a push towards — going towards pre-filled syringe. And actually all those things actually led to increasing volumes for Catalent as we move towards either single dose or lower volume formats and also boosters.

The other thing that I would tell you, Dave, is that Catalent has now put itself into the vaccine category in a really substantial way. It was always, I would say, a significant category within Catalent. Catalent has now moved up within our overall look of the overall categories within Catalent and with the capacity and capabilities. And quite frankly, the strong brand reputation of being able to deliver in this crazy tumultuous time of COVID vaccines has elevated our status as a CDMO in the vaccine category.

We also see that mRNA is not just going to be a COVID vaccine therapeutic platform. As you know, Moderna had quite a large pipeline, if you will, of mRNA vaccines. We’re partnered very closely with them with COVID. We certainly expect them as well as other partner, J&J, to be using our expertise for non-COVID related vaccine items, which I won’t detail here in the call. But from a Catalent standpoint, again, COVID was an accelerator of our strategic plans. And quite frankly, our growth and our ability to upgrade our long-term guidance now from 6% to 8% to 8% to 10% revenue growth I think is a testament of that and also point to the fact that, as you know, we’ve held onto our long-term growth guidance for quite some time since 2014 before bringing it up with the acquisition of Paragon and now bringing it up here in this earnings call.

So that alone should tell you what our outlook is with regards to the growth rate of the company and how we see vaccines continue to play a strong role into the future without any, I would say, substantial cliff in terms of the business since we’ll be dovetailing in some of our strong pipeline along with the continued sustained supply required for the COVID vaccine. Sorry for the somewhat labored answer, but it’s a really important question and it’s important for me to be able to castle all of that information broadly to the analysts and investors.

David Windley — Jefferies — Analyst

Yeah, yeah. Thanks for the context there. I appreciate that. Quickly on margin. Margins were strong, perhaps the composition of those was a little bit different than I and others expected. In the biologics segment, could you comment on whether there was a mix change there or you mentioned reservation fees in the context of another answer? Was there some impact that caused the biologics margin to drop a little bit from what we’ve seen the last couple of quarters?

Thomas Castellano — Senior Vice President and Chief Financial Officer

Yeah, Dave, Tom here. So just under 31% EBITDA margin for the fourth quarter here for the business. A great performance from where we were a year ago. You’re right, sequentially it’s down from what we were third quarter levels. I’d just point to a couple of things here. We have to remember that this is still primarily development business. And with that, does come some, I would say, volume-related lumpiness that could have a negative impact on margin. But the fact that we’re seeing the sustainable margins within this business, north of 30%, is something right in line with where management expected it to be.

The other thing I would highlight here is component sourcing continues to be a growing revenue stream within the business. These are the pass-through revenues associated with some of the components used for the vaccines that comes in at a very low margin profile, and we’re seeing that increase having a little bit of a drag. The other thing I would say is, we think about the level of maturity within our cell and gene therapy business, cell therapy primarily the investments that we continue to put into that business are, I would say, relatively substantial from an operating cost perspective, and you have a little bit of a headwind to the margin profile of biologics. But again, I just want to highlight the 31% that we saw in the fourth quarter. And again, right in line with where we expected that to be from a management standpoint and seeing sustainable margins above 30% within biologics.

David Windley — Jefferies — Analyst

Got it. Thank you.

Operator

Your next question is from Paul Knight with KeyBanc Capital Markets.

Michael Turits — KeyBank — Analyst

Mike on for Paul. First one, John, it’s nice to see Catalent continue to build up its presence in biologics in Europe with the Anagni announcement. Just as a follow-up, you’re obviously building out significant capacity in the U.S. related to viral vectors, but given the capacity constraint in that market, when does it start to make sense to have a presence there for viral vectors given your significant cell therapy and plasmid DNA presence already there?

John Chiminski — Chair and Chief Executive Officer

Actually, thank you for that highlight. It’s published and I’ve also noted that that is also a category that we’re looking at within Europe. Clearly, we’ve got a strong footprint for cell therapy across our Gosselies Belgium campus now and also in Houston and we have a huge capability in viral vector manufacturing in the Baltimore area. But if we were able to get our hands on the right asset from a viral vector manufacturing standpoint in Europe, that would also be a priority for us.

We continue to see an extremely strong pipeline in the overall gene and cell therapy space. And I do believe that having assets in the right area are going to be key. We love being in Baltimore given that that really is kind of a center from an overall, I would just say, the wallet lead standpoint. But clearly, Europe will also be an area where we’re going to continue to look for an asset there. And if we’re not — even we get our hands on one, we may pursue the organic build out route, but that would obviously take some additional time. So thank you for actually highlighting.

Michael Turits — KeyBank — Analyst

And then just following up on Tom’s past comment with respect to gene-based vaccine, specifically mRNA kind of having a long duration for Catalent outside of COVID. These type of vaccines and therapeutics are more challenging to deliver to the body, you have purchased the upstream tech with Delphi and historically have been strong and don’t finish with therapeutics and vaccines. But — and then obviously you have the bottle-based delivery technology with Paragon. But do other delivery technologies like lipid nanoparticles and electroporation kind of make sense for an R&D perspective or potential M&A perspective for Catalent? Thank you.

John Chiminski — Chair and Chief Executive Officer

Yeah. Certainly, I would just say that LNP or lipid nanoparticles are a big part of the secret sauce for mRNA delivery. We know with regards to one very large specific provider of that, they kept a lot of that in-house. And then with another provider, they are partnered, but there is a lot of wraps around I would say, the know-how and the intellectual property of those LNPs. It is an area that is high on our list. I’ve actually had some dialogues with one large customer about the ability to Catalent to be their LNP provider and broad-based from -mRNA standpoint. So we’re early on in those discussions, but it is a key area.

I have to emphasize, again, I mentioned our science and technology team is constantly on the hunt for and looking out with advanced radar to understand what are the key technologies and the key growth areas that Catalent needs to be participating in. And an example of that is the LifeCell acquisition, which again, we think it’s going to be key for us in the cell therapy, regenerative medicine area. So we’ll continue to see Catalent bringing in those type of technologies into the company. And certainly, the mRNA space is going to continue to be — I mean with two approved products here, it’s clearly now it’s going to be a therapeutic category. We will all going to be watching what they’re going to be able to do beyond vaccines. And the great news is, we are partnered with clearly one of the best, if not the best, in this area.

Michael Turits — KeyBank — Analyst

Great. Thank you for the time.

Operator

Your next question is from Sean Dodge with RBC Capital.

Sean Dodge — RBC — Analyst

Thanks. Good morning. Maybe going back to Bettera, on the margin. John, you said, incredibly attractive, already accretive to the consolidated total, is there any more specificity you can share there? And then just to better understand the trajectory or potential. I guess, if we roll forward a few years of 20% plus revenue growth, is there a lot of opportunity to continue scaling mills higher or with the tight capacity constraints, are things there as good as they could or should be, it’s just more adding revenue at those margins?

John Chiminski — Chair and Chief Executive Officer

So first let me just make the statement that this is a category that has biologics go higher margins to it. So when we talk about it being accretive and then accretive to overall Catalent that should give you signal.

Let me just back up a little bit here. Gummies have become the dominant experiential delivery format in BMS. And the BMS retail market is growing three times faster than the rate of over-the-counter. It’s actually now larger than over-the-counter. Through the pandemic and even running up to the pandemic, wellness has really become something of a personal responsibility and people are really going up faster nutritional, nutraceutical and other functional areas, and gummies have been booked for that. In fact, launching the most number of products in this category compared to everybody else. Gummies have grown grow more than 20% CAGR per year for the last four years and now represents more than 30 billion doses.

The BMS segment is growing in mid-single-digits, but gummies, despite representing less than 20% of delivery formats, have accounted for greater than 50% of total BMS growth over the last several years. Nearly 70% is outsourced with a limited number of CDMOs and it’s capacity constrained. And again, what does Catalent do well? We do things at scale. So our ability to scale this business appropriately to be able to not only grow with the market, but to grow substantially faster than the market that is capacity constrained compared to competition is really where we’re going to be able to drive this to be kind of the number one franchise out there from a CDMO standpoint. That’s why we got into this. So it’s really again a terrific business for us, very high margins and one that Catalent can get its hands on, integrate. We have very detailed plans and in scale.

Sean Dodge — RBC — Analyst

Okay. And maybe skill is a little bit of the answer to my next question. But it’s easy to see how Catalent can differentiate itself and sustain high margin in the biologics and cell and gene therapy just given the scientific rigor involved there. On to the peer side, maybe just if you could talk a little bit more about what is the differentiating factor in that gummy or the neutraceutical? What is a competitive moat look like there?

John Chiminski — Chair and Chief Executive Officer

So to give you a sense for the level of difficulty with all the capabilities that we have within Catalent, specifically in Softgel, gelatin and the franchise that we had there in the BMS standpoint, we were unable to attack the space organically. And the reason is, there is incredible amount of know-how in terms of developing these products with the right texture and flavors. And so this is not something that you can just buy a machine and go. It’s really built upon the capability of the team to formulate those products.

And the other part of this is not just the ability to formulate, but proactively formulate these products because essentially what customers are buying our off-the-shelf products that have been already proactively developed. So for Catalent, with all of our skills and capabilities, we really ran into a wall in terms of being able to build this business organically over the last five years and ultimately went down the inorganic front, found one of the leading players, we believe they are the number two player in the space and our goal is to make them the number one player, pure and simple. So again, very substantial.

I know that some people that don’t understand Catalent very well will look at all of the biologics gene therapy and cell therapy acquisitions that we’ve done and say I don’t get it. But that’s because they don’t understand the fact that we are supplying to biopharmaceutical customers and consumer health customers, and our consumer health customers have been stable base for this company for many, many years. In fact, the team that have been here for 20 plus years said that Catalent literally developed to our Softgel business the cough and cold category that we now see ubiquitously on the shelves of Walgreens, Walmarts and CDS.

So this is in our DNA. It requires innovation. There’s a different clock speed that’s required in this category. And we have longstanding relationships with all the big six players in the consumer health category, which again, the BMS category has been growing faster, three times faster than OTC folks. So for Catalent, this actually was a natural, if not, slightly late acquisition into this very fast growing space.

Sean Dodge — RBC — Analyst

Okay, all right. That’s great. Very helpful. Thanks again.

Operator

Your next question is from Juan Avendano with Bank of America.

Juan Avendano — Bank of America — Analyst

Hello. Thank you. Just one question for me. You alluded to the change in the COVID vaccine and packaging configuration in a previous answer. Can you tell us how is the potential of revenue and margin from a fewer of those formats compared to the current format? And by when would you anticipate this change to come into effect?

John Chiminski — Chair and Chief Executive Officer

I’ll answer this at a high level that says that from a Catalent perspective, we are not paid per dose, we are paid per cell. So if you have cells that are at a lower number of doses, it means you generally need more cells. So from an overall Catalent perspective, it’s a positive tailwind. If you go to formats that have fewer doses per vial or potentially into the pre-filled syringe format, you can expect those to be again at strong margins.

Juan Avendano — Bank of America — Analyst

Thank you.

Operator

Your next question is from George Hill with Deutsche Bank.

George Hill — Deutsche Bank — Analyst

Hey, good morning, guys. Thanks for taking the question. I’m going to come back to the topic of M&A one last time, John. Maybe just talk about, John, you used pretty aggressive language earlier as it relates to the company’s M&A profile. I guess, can you talk about the processes that you went through the company wasn’t able to get to the goal line on? Kind of what was the barrier there? Was it valuation? Was it bidding environment? Was it not the right asset? I mean you guys have been so successful, I’d kind of like to hear more about what went wrong in the M&A process?

John Chiminski — Chair and Chief Executive Officer

I’m sorry, I didn’t quite get the question about what went wrong on the M&A process. Can you just perhaps a little bit explain?

George Hill — Deutsche Bank — Analyst

Yeah, sure. You talked about a couple of bidding processes where you guys couldn’t get to the goal line, and you guys have been very successful in M&A. I guess, I’d love to hear more about what went wrong when you guys couldn’t deals [Speech Overlap]

John Chiminski — Chair and Chief Executive Officer

Yeah, nothing went wrong. It’s usually a case of us being disciplined acquirers both in terms of valuation. I would say, nothing has gone wrong in our process. At some point, the valuations get to a point where they didn’t make sense from an overall Catalent perspective. But I would just say that our processes are incredibly strong. They led to the string of acquisitions that we’ve done, starting with Cook Pharmica, through Paragon, through Masthercell, through all of the campuses that we’ve built out in Gosselies. But again, doing M&A requires a certain level of discipline so that at some point the value for the asset doesn’t make sense and we kind of moved on.

So just put this under the category of disciplined acquirer where we moved on. And as you’ve seen, we’ve taken a path that doesn’t limit us by expanding pretty quickly organically in the BMS facility that we purchased that’s in Anagni as well as expanding our Limoges facility. So we’ll continue to aggressively look for those assets. But M&A is not purely deterministic activity. It involves a lot of considerations in terms of moving forward in the process.

George Hill — Deutsche Bank — Analyst

That’s kind of what I expected. I appreciate it. Thanks, John.

Operator

There are no further questions at this time. I will now hand the call back over to Mr. Paul Surdez, CEO, for final comments.

Paul Surdez — Vice President of Investor Relations

Actually, our judgments do conclude here. Thanks, operator, and thanks everyone for your questions and for taking the time to join our call. I’d like to close by highlighting a few key points we covered today. Fiscal 2021 was an incredible year for Catalent. We didn’t just outperform our expectations for 2021 during a global crisis, but our rapid response to the pandemic gave us the opportunity to do real good for the entire world, provided an insightful demonstration of the depth of our capabilities, significantly elevated our brand, helped increase our engagement with our employees as we’ve banded together to meet the challenges of pandemic and enabled us to accelerate our strategic plans and investments.

In fiscal 2022, we expect strong revenue and EBITDA growth again, driven by continued growth in our biologics segment as well as a return to growth in our SOT and OSD segments. Because of the investments we’ve made over the past few years, which included adding high growth franchises like those we’ve acquired in our biologics segment and like the one we now anticipate with the tier-up with stronger and better positioned for long-term growth than ever before as evidenced by the increase in our projected long-term net revenue growth target to 8% to 10%.

Finally, I’m very proud of the team of more than 17,000, and the way we’ve lived up to our mission to help people live better healthier lives. When we look back at our last fiscal year, we know that across the 1,400 development programs we advanced and the 7,000 products we manufactured on behalf of our clients, we helped enhance the lives of millions of patients around the world. Thank you.

Operator

[Operator Closing Remarks].

Disclaimer

This transcript is produced by AlphaStreet, Inc. While we strive to produce the best transcripts, it may contain misspellings and other inaccuracies. This transcript is provided as is without express or implied warranties of any kind. As with all our articles, AlphaStreet, Inc. does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company’s SEC filings. Neither the information nor any opinion expressed in this transcript constitutes a solicitation of the purchase or sale of securities or commodities. Any opinion expressed in the transcript does not necessarily reflect the views of AlphaStreet, Inc.

© COPYRIGHT 2021, AlphaStreet, Inc. All rights reserved. Any reproduction, redistribution or retransmission is expressly prohibited.

Most Popular

Stitch Fix (SFIX) Stock: Will the innovative biz model survive virus-led slump?

The business world is still struggling to come out of the virus-induced slowdown, but it seems almost every retail segment benefited from the pandemic at some point. The vaccination drive

General Mills (GIS): Three factors that are expected to help drive growth for the food company going forward

Shares of General Mills Inc. (NYSE: GIS) were up 3.2% on Wednesday after the company delivered better-than-expected results for the first quarter of 2022. Net sales rose 4% year-over-year to

IPO Alert: Allvue Systems sets IPO terms, to raise around $290 million

It is estimated that the alternative investments industry has expanded at a compound annual rate of 10.2% over the past ten years and had $11 trillion in assets under management

Add Comment
Loading...
Cancel
Viewing Highlight
Loading...
Highlight
Close
Top