Catalent, Inc. (“Catalent” or the “Company”) (NYSE: CTLT), the
leader in enabling the development and supply of better treatments
for patients worldwide, today announced a business update. While
complete financial information and operating data for the Company’s
third fiscal quarter ended March 31, 2023 are not yet finalized,
the Company expects that productivity issues and
higher-than-expected costs experienced at three of its facilities,
including two of its largest manufacturing facilities, during the
quarter will materially and adversely impact the Company’s
financial results for the third fiscal quarter and its outlook for
the remainder of the 2023 fiscal year.
The Company also today announced that Ricky Hopson will assume
the role of Interim Chief Financial Officer, effective April 14,
2023. Catalent is engaging a leading, global executive search firm
to evaluate candidates for a permanent Chief Financial Officer.
Business Update
One of the facilities that experienced productivity issues is
the Company’s gene therapy manufacturing site located in Harmans,
Maryland near the BWI airport (“BWI”), where the Company’s plans to
increase capacity for a customer’s product during the third quarter
in order to ramp production was slower than expected. During this
ramp-up, certain operational challenges, including those related to
the initial deployment of a new enterprise resource planning (ERP)
system at BWI, significantly reduced the expected revenue in the
third fiscal quarter associated with the site, and will also impact
revenue previously expected in the fourth quarter.
Timely resolution of these issues was delayed by the necessity
of focusing site resources on important regulatory inspections
involving the BWI site, which were successfully completed. The
ERP-related challenges were operational in nature and will not
impact the Company’s ability to produce timely and accurate
financial statements.
None of these issues is expected to adversely impact the quality
or commercial launch quantities of any product made at BWI in light
of, among other things, the level of “bright stock” on hand.
However, revenue from the unproduced batches cannot be made up for
in this fiscal year due to manufacturing capacity constraints. The
Company expects to recover related revenue in the second half of
calendar year 2023 (the first half of the Company’s 2024 fiscal
year).
In the third fiscal quarter, the Company also experienced
productivity challenges and higher-than-expected costs at its drug
product and drug substance manufacturing facilities located in
Bloomington, Indiana and Brussels, Belgium, where the Company was
unable to achieve anticipated productivity levels and associated
revenue due in part to the continued need to implement enhancements
to its operational and engineering controls following regulatory
inspections that occurred earlier in the fiscal year. While these
issues are also expected to affect the Company’s fiscal fourth
quarter to end on June 30, 2023, productivity levels in Bloomington
are expected to be restored to previously forecast levels in that
quarter. As with BWI, the Company does not expect to make up for
the lost production at Bloomington until after the close of the
current fiscal year.
After conducting an internal review of the Company’s
manufacturing operations, the Company has taken a number of
measures at BWI, Bloomington, and Brussels, including both
management and operational changes, to address the root causes of
the issues identified at each site.
Ricky Hopson Named Interim Chief Financial Officer
Ricky Hopson, who had been serving as the Company’s President,
Division Head for Clinical Development & Supply, will assume
the role of the Company’s Interim Chief Financial Officer,
effective April 14, 2023, following the departure of Thomas
Castellano as the Company’s Senior Vice President and Chief
Financial Officer on April 13, 2023.
“Ricky is an experienced financial executive who deeply
understands Catalent and can successfully lead our financial
function through this interim period until we identify a new,
permanent CFO,” said Alessandro Maselli, President and Chief
Executive Officer. “We also thank Tom for his 15 years of service,
during which he played an integral role in our successful initial
public offering in 2014 and served in multiple senior positions. We
wish Tom well in his future endeavors.”
Mr. Hopson, 47, has served as President, Division Head for
Clinical Development & Supply since July 2022. Prior to that,
he served the Company for more than 20 years in a variety of
finance roles, most recently as the Company’s Vice President &
Chief Accounting Officer since June 2021. Prior to that, Mr. Hopson
served the Company as Vice President & Corporate Controller,
Global Vice President, Operational Finance, and Vice President of
Finance for two different business units. Mr. Hopson graduated from
the University of Portsmouth and is a chartered management
accountant in the U.K.
Third Quarter Fiscal Year 2023 Earnings Conference
Webcast
The company expects to release financial results for the third
quarter of fiscal year 2023, ended March 31, 2023, before the
market open on Tuesday, May 9, 2023, and will host a webcast to
discuss the results at 8:15 a.m. ET on the same day. Catalent
invites all interested parties to listen to the webcast and view a
supplemental slide presentation, both of which will be accessible
through Catalent’s website at https://investor.catalent.com. The
webcast replay, along with the supplemental slides, will be
available for 90 days at https://investor.catalent.com.
About Catalent
Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the
global leader in enabling pharma, biotech, and consumer health
partners to optimize product development, launch, and full
life-cycle supply for patients around the world. With broad and
deep scale and expertise in development sciences, delivery
technologies, and multi-modality manufacturing, Catalent is a
preferred industry partner for personalized medicines, consumer
health brand extensions, and blockbuster drugs. Catalent helps
accelerate over 1,000 partner programs and launch over 150 new
products every year. Its flexible manufacturing platforms at over
50 global sites supply around 80 billion doses of nearly 8,000
products annually. Catalent’s expert workforce of approximately
18,000 includes more than 3,000 scientists and technicians.
Headquartered in Somerset, New Jersey, the company generated nearly
$5 billion in revenue in its 2022 fiscal year. For more information
www.catalent.com.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. All statements contained in this Form 8-K that do not relate
to matters of historical fact should be considered forward-looking
statements, including without limitation statements regarding the
resolution of issues at three of the Company’s manufacturing
facilities, the impact of such issues on product made at BWI, the
timing of recovering unproduced batches at BWI, the timing of the
resumption of normal operations at the three facilities, and the
impact of such issues on the Company’s financial results for the
fiscal quarter ended March 31, 2023 and the fiscal year to end on
June 30, 2023. These forward-looking statements are based on
management’s current expectations. These statements are neither
promises nor guarantees, but involve known and unknown risks,
uncertainties and other important factors that may cause the
Company’s actual results, performance or achievements to be
materially different from the Company’s expectations and
projections expressed or implied by the forward-looking statements,
including, but not limited to, general business, financial and
accounting risks and the other important factors discussed under
the caption “Risk Factors” in the Company’s Annual Report on Form
10-K for the year ended June 30, 2022, filed with the U.S.
Securities and Exchange Commission, or the SEC, and the Company’s
other filings with the SEC. In addition, the statements regarding
the impact of productivity issues on the Company’s financial
results for the fiscal quarter ended March 31, 2023 and the fiscal
year to end June 30, 2023 are not a comprehensive statement or
estimate of the Company’s financial results for such periods or of
the events that may have affected the Company’s financial results
for the fiscal year ended March 31, 2023 or that may affect the
Company’s financial results for the fiscal year to end June 30,
2023. The Company’s actual results for the fiscal quarter ended
March 31, 2023, and for the fiscal year to end June 30, 2023 may
differ materially from what may be implied by, or be expected from,
the statements regarding the impact of such issues on the Company’s
financial results. Forward-looking statements speak only as of the
date of this press release and are based on information available
to the Company as of the date of this press release, and the
Company assumes no obligation to update such forward-looking
statements, whether as a result of new information, future events
or otherwise.
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version on businesswire.com: https://www.businesswire.com/news/home/20230414005072/en/
Investor Contact: Paul Surdez, Catalent, Inc. (732) 537-6325
investors@catalent.com Media Contact: Chris Halling +44 (0)7580
041073 media@catalent.com
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