Lifecore Biomedical, Inc. (NASDAQ: LFCR) (“Lifecore” or the
“Company”), a fully integrated contract development and
manufacturing organization (“CDMO”), today provided a business
update, including certain select preliminary financial data,
outlook for full year fiscal 2024, the status of its development
portfolio and pipeline and capacity expansion.
James G. Hall, President and Chief Executive
Officer of Lifecore, commented, "I’m excited to deliver today’s
business update, which is consistent with the expectations that we
laid out last August. Our team has been doing a great job of
ramping up our commercial presence in the market over the past two
years in advance of our expanded capacity and this has proven to be
a timely initiative given recent disruptions within the industry
that has created a heightened desire for quality filling capacity.
We remain in a strong position with our demonstrated capabilities
and focus on quality and are working diligently to bring in new
projects and convert existing commercial opportunities within our
development portfolio.”
Mr. Hall continued, “Lifecore has a lengthy
runway of growth ahead with approximately 70 million units of
theoretical capacity when our new fillers are installed, tested,
and qualified. The current estimates for theoretical capacity have
resulted from extensive factory acceptance testing associated with
the new isolator fillers, including evaluating filling speeds and
volumes, modeling the types of product formulations under
evaluation with our pipeline. With the successful installation and
validation of our new isolator fillers, we have the potential to
triple our current manufacturing capacity and revenue generating
capacity from anticipated fiscal year 2024 levels, depending on the
types of products being filled and the average unit price. The
opportunities we are seeing are as diverse as they’ve ever been and
our team is working diligently to bring this new capacity online to
capitalize on the opportunities in the robust market, while
simultaneously ensuring we have the human capital to support
it.”
Development Portfolio
UpdateLifecore continues to see growth fiscal year-to-date
in its pipeline opportunities for development and late-stage
programs, ending fiscal third quarter 2024 with 33 total projects.
The Company’s targeted approach has resulted in a doubling of
prospective engagements with larger and more traditional
pharmaceutical companies in the fiscal year-to-date period, and
currently represent approximately one-third of its prospective
opportunity set. Beyond those projects currently in the development
portfolio, the Company’s prospective pipeline is comprised of 68
opportunities currently in discussion.
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Fiscal Year |
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Quarter |
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Quarter |
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Quarter |
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Ended |
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Ended |
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Ended |
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Ended |
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Fiscal |
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May 28, |
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August
27, |
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November 27, |
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February
25, |
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YTD |
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|
2023 |
|
2023 |
|
2023 |
|
2024 |
|
Change |
|
Development programs under contract |
29 |
|
31 |
|
32 |
|
33 |
|
+4 |
|
Early phase / proof of concept |
7 |
|
8 |
|
9 |
|
9 |
|
+2 |
|
Phase 1 and 2 clinical development |
8 |
|
8 |
|
8 |
|
8 |
|
|
|
Phase 3 clinical development or scale up/commercial validation |
14 |
|
15 |
|
15 |
|
16 |
|
+2 |
|
Commercial projects manufactured |
27 |
|
29 |
|
29 |
|
29 |
|
+2 |
|
Clients with commercial projects |
14 |
|
14 |
|
14 |
|
14 |
|
|
Capacity Update and Isolator Filler
StatusLifecore continues to work towards the installation
and qualification of its high-speed multi-purpose 5-head and
10-head isolator fillers and currently estimates that its
theoretical annual aseptic production capacity would increase to
approximately 70 million units in fiscal year 2027, which is more
than triple the Company’s current theoretical capacity of 22
million units. The current estimates for theoretical capacity have
resulted from extensive factory acceptance testing associated with
the new isolator fillers, including evaluating filling speeds and
volumes, modeling the types of product formulations under
evaluation with our pipeline. The Company currently expects its
5-head filler to be GMP ready in August 2024.
Lifecore’s Hyaluronic Acid (“HA”) supply
agreement with Alcon also continues to advance with progress on
transitioning to a 24/7 labor force. The Company has already
increased HA capacity by 38% since the beginning of fiscal year
2024 and currently anticipates further increases through yield
improvements of approximately 20% during fiscal year 2025.
Certain Preliminary Unaudited Historical
Financial DataSet forth below are preliminary estimates of
certain consolidated financial data of Lifecore as of and for the
fiscal quarters ended August 27, 2023, November 26, 2023, and
February 24, 2024, and the nine months ended February 24, 2024 (the
“Historical Periods”). Our actual consolidated financial results
remain subject to completion of our quarterly financial closing
procedures and preparation of our actual consolidated financial
results as of and for the Historical Periods, which have commenced
but are not yet completed Our actual consolidated financial results
as of and for the Historical Periods are expected to be reported in
connection with the filings of our Quarterly Reports on Form 10-Q
for the Historical Periods, once available. We based these
estimates on the information available to us as of the date of this
release, and our actual consolidated financial results for the
Historical Periods may differ materially from these preliminary
estimates, including as a result of audit adjustments and other
developments that may arise between now and the time our actual
consolidated financial results for the Historical Periods are
finalized and reported. Moreover, these preliminary estimates
should not be viewed as a substitute for actual consolidated
financial statements and related notes as of and for the Historical
Periods prepared in accordance with Generally Accepted Accounting
Principles (“GAAP”). Accordingly, you should not place undue
reliance on these preliminary estimates.
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First Quarter
Ended |
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Second Quarter Ended |
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Third Quarter Ended |
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Nine Months Ended |
($ in millions) |
Estimated |
Restated 1 |
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Estimated |
Restated 1 |
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Estimated |
Restated 1 |
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Estimated |
Restated 1 |
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August 27, |
August 28, |
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November 26, |
November 27, |
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February 25, |
February 26, |
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February 25, |
February 26, |
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|
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|
2023 |
|
|
2022 |
|
|
|
2023 |
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|
2022 |
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|
2024 |
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|
2023 |
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|
2024 |
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|
2023 |
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Revenues |
$ |
24.5 |
|
$ |
23.7 |
|
|
$ |
30.2 |
|
$ |
21.9 |
|
|
$ |
35.8 |
|
$ |
26.5 |
|
|
$ |
90.5 |
|
$ |
72.1 |
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|
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Cash |
|
$ |
8.6 |
|
$ |
2.5 |
|
|
$ |
3.2 |
|
$ |
5.9 |
|
|
$ |
3.2 |
|
$ |
3.0 |
|
|
$ |
3.2 |
|
$ |
3.0 |
|
|
|
|
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Total term debt and revolver |
$ |
172.9 |
|
$ |
147.7 |
|
|
$ |
174.1 |
|
$ |
151.7 |
|
|
$ |
180.7 |
|
$ |
123.1 |
|
|
$ |
180.7 |
|
$ |
123.1 |
|
|
Less debt discount and issuance costs |
|
(63.4 |
) |
|
(5.1 |
) |
|
|
(61.3 |
) |
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(4.8 |
) |
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|
(59.2 |
) |
|
(8.1 |
) |
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(59.2 |
) |
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(8.1 |
) |
Total debt |
|
109.5 |
|
|
142.6 |
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|
|
112.8 |
|
|
146.9 |
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|
|
121.5 |
|
|
115.0 |
|
|
|
121.5 |
|
|
115.0 |
|
Net debt (total debt less cash) |
|
100.9 |
|
|
140.1 |
|
|
|
109.6 |
|
|
141.0 |
|
|
|
118.3 |
|
|
112.0 |
|
|
|
118.3 |
|
|
112.0 |
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|
|
|
|
|
|
|
|
|
|
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Total lease liabilities |
$ |
10.7 |
|
$ |
11.6 |
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|
$ |
10.5 |
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$ |
11.4 |
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|
$ |
10.2 |
|
$ |
11.2 |
|
|
$ |
10.2 |
|
$ |
11.2 |
|
Debt derivative liability |
|
61.2 |
|
|
- |
|
|
|
63.9 |
|
|
- |
|
|
|
60.2 |
|
|
- |
|
|
|
60.2 |
|
|
- |
|
Series A convertible preferred stock |
|
40.1 |
|
|
- |
|
|
|
40.9 |
|
|
- |
|
|
|
41.7 |
|
|
38.5 |
|
|
|
41.7 |
|
|
38.5 |
|
|
|
|
|
|
|
|
|
|
|
|
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Purchases of property, plant and equipment 2 |
$ |
5.1 |
|
$ |
3.4 |
|
|
$ |
4.0 |
|
$ |
3.8 |
|
|
$ |
6.3 |
|
$ |
7.1 |
|
|
$ |
15.3 |
|
$ |
14.3 |
|
|
|
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1 |
References to restated
refers to the restated information contained in the Company's
Annual Report on Form 10-K for the year ended May 28, 2023. |
2 |
Purchases of property,
plant and equipment includes approximately $2.5 million of
capitalized interest for FY23 as interst was paid in cash on the
term debt. In FY24, purchases of property, plant and equipment
excludes capitalized interest as interest is paid-in-kind on the
term debt. |
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These preliminary estimates have been prepared
by, and are the responsibility of, our management. No independent
registered public accounting firm has audited, reviewed, compiled
or applied agreed-upon procedures with respect to these preliminary
estimates, and thus no such firm has expressed an opinion or any
other form of assurance with respect thereto.
Liquidity and Business
UpdatesThe Company believes that its capital structure
remains in a stable condition following its comprehensive
refinancing in May 2023. The Company also believes it has
sufficient liquidity to achieve its strategic plan over the next 12
months as of the date hereof. During fiscal year 2024, Lifecore
completed the following liquidity and business update matters which
are included in the preliminary unaudited historical financial data
above and were disclosed as subsequent events in the Company’s 2023
Annual Report on Form 10-K. Lifecore successfully entered into an
amended and restated supply agreement with one of its customers
which provided revised pricing and payment of a $5 million working
capital deposit which was received in December 2023. The Company
also made significant progress in clearing up former business
dealings associated with its since divested Curation Foods segment,
including: $2.7 million of cash proceeds from its sale of O Olive,
receipt of a $1.85 million insurance settlement, and $0.9 million
in settlement of a note receivable from a former supplier.
Supplemental InformationThe
Company has furnished a supplementary investor presentation related
to its ongoing business to assist investors with current
information about the business. The supplementary investor
presentation can be found in the Investors section of the Lifecore
website at https://ir.lifecore.com/.
Fiscal 2024 OutlookLifecore’s
fiscal 2024 performance to date is consistent with its prior
expectations, including an acceleration in revenue that began in
the fiscal second quarter and further accelerated during the second
half of the fiscal year. This dynamic was due to an improvement in
margins that were the result of product mix associated with new
commercial shipments, improvement in legacy contracts, strong
fermentation revenues, and pipeline development projects that came
online during the second quarter.
The Company is introducing guidance for full
year fiscal 2024. Lifecore results solely reflect those of its
ongoing life sciences business.
- Revenue: Expected to be in the
range of $125 million to $130 million, depending on timing of
customer shipments in fiscal fourth quarter
- Adjusted EBITDA: Expected to be in
the range of $13.5 million to $16.9 million; includes estimated
corporate overhead (Former Other Segment) of approximately $10.3
million1
- Former Lifecore segment adjusted
EBITDA1 (for purpose of comparison to historical presentations;
excluding the impact of corporate overheard which was reported as
its own segment): Expected to be in the range of $23.8 million to
$27.2 million
- Capital expenditures: Expected to
be in the range of $19 million to $20 million, excluding
capitalized interest
1 In the Annual Report on Form 10-K for the
fiscal year ended May 28, 2023, the Company disclosed that it now
operates as a single segment reporter. The references to the former
Lifecore segment and the former other segment are being provided
here for comparability purposes as readers adjust to the Company’s
single segment reporting moving forward.
About Lifecore
BiomedicalLifecore Biomedical, Inc. is a fully integrated
contract development and manufacturing organization (CDMO) that
offers highly differentiated capabilities in the development, fill
and finish of complex sterile injectable pharmaceutical products in
syringes and vials. As a leading manufacturer of premium,
injectable grade Hyaluronic Acid, Lifecore brings more than 40
years of expertise as a partner for global and emerging
biopharmaceutical and biotechnology companies across multiple
therapeutic categories to bring their innovations to market. For
more information about the Company, visit Lifecore’s website at
www.lifecore.com.
Important Cautions Regarding
Forward-Looking StatementsThis press release contains
forward-looking statements regarding future events and our future
results that are subject to the safe harbor created under the
Private Securities Litigation Reform Act of 1995 and other safe
harbors under the Securities Act of 1933 and the Securities
Exchange Act of 1934. Words such as “anticipate”, “estimate”,
“expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”,
“will”, “should”, “can have”, “likely” and similar expressions are
used to identify forward-looking statements. In addition, all
statements regarding our preliminary estimates of historical
financial data for the Historical Periods, current operating and
financial expectations in light of historical results, anticipated
capacity and utilization, anticipated liquidity, and anticipated
future customer relationships usage are forward-looking statements.
All forward-looking statements involve certain risks and
uncertainties that could cause actual results to differ materially,
including such factors among others, as the outcome of any
evaluation of the Company’s strategic alternatives or any
discussions with any potential bidders related thereto, the
competition of the Company’s financial closing procedures, the
Company’s ability to successfully enact its business strategies,
including with respect to installation, capacity generation and its
ability to attract demand for its services, the Company’s ability
to become current with its reports with the Securities and Exchange
Commission (the “SEC”), and the timing thereof, the Company’s
ability to regain compliance with applicable listing standards
under Nasdaq, and its ability expand its relationship with its
existing customers or attract new customers, the impact of
inflation on the Company’s business and financial condition,
indications of a change in the market cycles in the CDMO market;
changes in business conditions and general economic conditions both
domestically and globally including rising interest rates and
fluctuation in foreign currency exchange rates, access to capital;
and other risk factors set forth from time to time in the Company’s
SEC filings, including, but not limited to, the Annual Report on
Form 10-K for the year ended May 28, 2023 (the “2023 10-K”). For
additional information about factors that could cause actual
results to differ materially from those described in the
forward-looking statements, please refer to our filings with the
Securities and Exchange Commission, including the risk factors
contained in the 2023 10-K. Forward-looking statements represent
management’s current expectations as of the date hereof and are
inherently uncertain. Except as required by law, we do not
undertake any obligation to update forward-looking statements made
by us to reflect subsequent events or circumstances.
Lifecore Biomedical, Inc. Contact
Information:Jeff Sonnek(646)
277-1263jeff.sonnek@icrinc.com
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