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Healthcare - Drug Manufacturers - Specialty & Generic - NASDAQ - US
$ 6.4
-4.19 %
$ 236 M
Market Cap
49.23
P/E
EARNINGS CALL TRANSCRIPT
EARNINGS CALL TRANSCRIPT 2023 - Q2
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Operator

Good morning, and thank you for joining the Lifecore Biomedical Fiscal 2023 Second Quarter Earnings Call. [Operator Instructions]. Now I'd like to turn the call over to Jeff Sonnek, Investor Relations at ICR. Please go ahead. .

Jeff Sonnek

Good morning, and thank you for joining us today to discuss Lifecore Biomedical's Second Quarter Fiscal 2023 Earnings Results and the strategic and commercial update that we provided via a series of concurrent press releases yesterday after the market closed.

Hosting the call today from the company are Jim Hall, President and Chief Executive Officer; and John Morberg, Chief Financial Officer..

Before we begin today, I'd like to remind everyone of the safe harbor statement. Certain statements made in the course of this conference call contain forward-looking statements. It is important to note that the company's actual results could differ materially from those projected in such forward-looking statements.

Additional information concerning risk factors that could cause actual results to differ materially from those in the forward-looking statements is contained from time to time in the company's filings with the SEC, including, but not limited to, the company's Form 10-K/A for fiscal year 2022..

Please note that the company has also completed its restatements associated with the retroactive impairment of its avocado products business, which has since been divested on February 7, 2023. These restatements include the fiscal 2022 10-K and the fiscal 2023 first quarter 10-Q. The company has also filed its fiscal 2023 second quarter 10-Q today.

Copies of these filings may be obtained from the SEC and the company's website..

Finally, in light of the company's announcement of its intention to explore its strategic alternatives, management will not be conducting a live Q&A session on today's call..

With that, I'd like to now turn the call over to Jim Hall, Chief Executive Officer.

Jim?.

James Hall Advisor

Thank you, Jeff. Good morning, everyone, and thank you for joining us for a long overdue update.

I want to start today by recognizing that the past several months have presented a series of unique challenges for the company, and we have a number of developments we intend to discuss today to bring you current with our business, including our announcement of our intent to explore strategic alternatives; the completion of the restatement of our consolidated financial statements for the fiscal year 2022 and fiscal first quarter 2023, which is previously disclosed related to noncash impairment charges on Curation Foods' avocado products business, which was sold in early February; and the filing of our amendment periodic reports for those periods; our ongoing concern determination and ongoing negotiations with our lenders; and of course, our fiscal second quarter results and an exciting update on our commercial development portfolio..

Despite our efforts over the past couple of years to unlock the potential of Lifecore as a stand-alone CDMO business through the divestitures of the Curation Foods' assets, those activities have not produced the necessary capital to free Lifecore from the heavy debt burden that we face today.

Our capital structure has been encumbered from several years of excess leverage and inadequate returns on capital from legacy Landec's Curation Foods segment..

Yesterday, the Board announced its intention to pursue strategic alternatives to maximize value for our stockholders, which may include an evaluation of potential sale of the company, potential debt or equity financing transactions or other possible strategic transactions.

We are pleased to announce that we have retained the expertise of Morgan Stanley to ensure that Lifecore is in position to capture the growth that resides within our development pipeline for the benefit of all of our stakeholders..

As part of the strategic review, Lifecore expects to evaluate various options that will allow us to continue supporting our amazing HA and CDMO businesses that have not only consistently grown but have done so in a responsible and profitable manner for decades.

We believe this is the prudent path forward to provide us with a sound financial footing that our company deserves after demonstrating more than 40 years of consistent execution. We expect to formally commence this strategic review process once the company has obtained a forbearance agreement from our lenders to facilitate that process..

Our immediate focus is to continue our work with our lenders to provide us with the flexibility to close on such a strategic solution and to mitigate some of the pressures created by our debt covenants in the near term.

Those discussions are in process, and it is premature to comment on the probability or timing of any potential outcome, including the terms of any potential modification or a forbearance agreement. We are grateful for their continued engagement in this process and intend to keep the investment community apprised once an arrangement has been reached..

As noted in our public filings, we have determined that there is substantial doubt as to the going concern of the company for the next 12 months. This is driven in part by our existing and anticipated issues under our credit arrangements and our liquidity needs over that period.

Our goal is to seek to mitigate these issues through our negotiations with the lenders and our strategic review process. We have greatly appreciated the continued support from the investment community through these challenging times, including the large stockholders who participated in the recent preferred equity raise to help in this regard.

But there's more work still to do..

While our Board and executive team have been engaged on these strategic processes, our commercial team at Lifecore continues to focus on driving our business forward, including enlarging our development portfolio. And in this regard, I'm extremely excited to share some great news about some of our recent successes..

Concurrent with yesterday's earnings release and strategic alternatives announcement, we also issued a release describing our term sheet for a significant expansion of our relationship with a long-term existing customer.

This term sheet contemplates a negotiation of a significant expansion of our manufacturing relationship, which we expect to finalize over the coming months, which we believe demonstrates the trust we've built with our quality systems and traction we are experiencing with existing and prospective customers as we continue to enhance our business with new capabilities and added capacity to support the continued expansion of our commercial product portfolio..

Additionally, the term sheet included a firm upfront cash commitment of $10 million, payable to Lifecore in installments over the next 7 months, to prepare infrastructure and manufacturing capacity, including the first $5 million payment received last week.

This customer has also committed to reimburse Lifecore for up to $15 million of CapEx to purchase equipment used in the expansion, which will be installed at our facilities..

This arrangement demonstrates the value of our existing CDMO capacity and ability to manage rapid growth and a great example of the work that our commercial team is doing to convert opportunities with large enterprises that will help drive our business and development portfolio in coming quarters and years..

Beyond this exciting development, we have also been executing across other areas of our portfolio, utilizing our business development team to drive visibility to our capabilities. In the fiscal second quarter, we had 63 new prospective opportunities in our development opportunity funnel that are in various stages of diligence and discussion.

Lifecore's full suite of capabilities across all aspects of the development cycle is a differentiator, which is a perfect complement to our flexible commercial manufacturing infrastructure that we continue to invest in.

Our strong development portfolio of active projects continues to grow, supported by the initiation of new projects and advancement of existing projects..

In the fiscal second quarter, we initiated work on 2 new development programs, both of which utilize Lifecore HA. We also had 1 early-phase project exit our active project portfolio due to changes needed to their formulation, and we are hopeful this program will be back once their process work is completed..

In total, as of the end of our fiscal second quarter, our active development projects increased by 1 to 25, comprised of 22 different customers.

These projects are spread across early-phase clinical development with 7 projects, Phase I and II clinical development with 9 projects and Phase III clinical development and scale-up commercial validation activity with 9 projects..

On a sequential basis, relative to our first fiscal quarter results, we continue to make progress with advancing projects within our portfolio. During our fiscal first quarter update, we noted 3 late-phase projects that were approaching FDA approval.

Each of those were successful and will be reflected in our fiscal third quarter commercial project portfolio update. We are now producing commercial material for these 3 products to support their ongoing commercial introduction to the market.

With the approval of these 3 products, Lifecore now manufactures and supports 29 commercial products with 14 different customers..

With these new product approvals now slated to be commercialized, and assuming the expansion of the long-term customer commercial agreement, we believe our pipeline could utilize our current theoretical capacity of 22 million units over the next several years.

We have also been working to increase our theoretical capacity with our new fillers that are being manufactured and will be delivered to us late this year and into early next year.

With our portfolio of current development projects and the pipeline of opportunities we are seeing, we believe the new fillers will be very timely to assist Lifecore in fulfilling the customer-forecasted commercial units we see on the horizon.

Once again, Lifecore is well positioned to take advantage of the strong industry fundamentals and customer projects as they progress through development and into commercialization..

In summary, we are making important progress on preparing Lifecore for future growth.

Our ability to drive a multiyear acceleration of annual revenue growth is underpinned by our current project portfolio characteristics and favorable industry tailwinds and is further supported by our strong development portfolio, expansion of our prospective development pipeline and the conversion of these projects into active projects..

I hope that the noise you've had to endure over these past several months is buttressed by the strong commercial update that we've provided here today. I believe we have an incredible opportunity, and we look forward to updating you on any outcomes from our strategic review process..

With that, I'll pass the call to John to discuss Lifecore's fiscal second quarter financials. .

John Morberg

Thank you, Jim. For the fiscal second quarter of 2023, Lifecore segment revenues decreased 13.1% to $21.7 million, driven by a 25% decrease in our CDMO business, partially offset by a 58% increase in our hyaluronic acid (HA) raw material manufacturing or fermentation business.

The decrease in our CDMO revenue was primarily due to a shift in the timing of commercial shipments to customers and lower development revenue associated with the delay in onboarding new customer development projects as well as more early-stage projects with lower initial revenues but strong runways in future periods.

The increase in HA raw material manufacturing revenue was primarily due to a prior year deviation in shipment timing, which was influenced by excess channel inventory during the global pandemic's reduction in elective procedures..

Lifecore segment gross profit decreased $5 million to $6.7 million for the second quarter of 2023, representing a gross margin of 30.8%, which compares to 47% in the prior year period.

The gross profit decline was primarily due to an unfavorable volume variance of $1.5 million due to the year-over-year revenue decline and an unfavorable rate variance of $3.5 million due to an unfavorable mix in current year commercial products and development revenues, somewhat offset by stronger HA fermentation revenues..

Lifecore segment-adjusted EBITDA was $3.1 million for the second quarter of 2023, representing an adjusted EBITDA margin of 14.3%. While we are withdrawing our fiscal 2023 outlook, due to our intention to explore a review of strategic alternatives, I want to ensure that near-term expectations are properly set.

The shift in the timing of shipments to customers and the lower development revenue associated with the delay in onboarding new customers as well as more early-stage projects with lower initial revenues that we experienced in our fiscal second quarter is expected to persist through fiscal third quarter as well.

We anticipate a larger fourth quarter as a result of this timing, but we are not providing any greater precision at this point, given our intention to explore a strategic alternatives review process..

Now turning to our balance sheet at the end of fiscal second quarter, please note that Curation Foods, Yucatan and O Olive assets and liabilities and the impact of the segments' cash flows are still reflected in our consolidated financial statements.

Since we divested the avocado products business, subsequent to our second quarter period ending, we will report our next fiscal third quarter with a balance sheet that excludes the avocado products business and the sale price of $17.5 million..

Net bank debt on a reported basis for the fiscal second quarter ended November 27, 2022, was $140.1 million, which compares to net bank debt at the end of fiscal '22 of $136.5 million. With the going concern qualification we made on our reported financials, please note that long-term debt has been reclassified to current liabilities..

CapEx was $3.3 million for the fiscal second quarter and $6.2 million in the year-to-date 6-month period. CapEx is focused on supporting Lifecore's long-term growth initiatives and is earmarked for 2 multiuse isolator fillers and the associated formulation and process support equipment.

Once again, in light of the intention to explore a strategic alternatives review, our prior CapEx guidance can no longer be relied upon.

However, as you heard today, with respect to our long-term customer term sheet and the associated CapEx support of up to $15 million that this customer will be paying for, we continue to feel good about our abilities to meet near-term demand while also onboarding this ramp in production in the coming years..

As previously publicly announced, subsequent to fiscal second quarter end, we closed on a $38.75 million PIPE in the form of convertible preferred equity that you will see reflected on our fiscal third quarter balance sheet. This capital was provided by a consortium of existing stockholders to provide the company with additional liquidity.

We are appreciative of the support from all of our investors across the capital structure. We look forward to speaking with you again when we report our fiscal third quarter results..

That concludes our call today. Thank you very much for participating. .

Operator

Thank you. This concludes today's conference. You may now disconnect your lines, and have a wonderful day..

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