UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): January 10, 2022
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation) | (Commission file number) | (IRS Employer Identification No.) | ||||||||||||
| | ||||||||
| (Address of principal executive offices) | (Zip Code) | |||||||
(650 ) 306-1650
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |||||
| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |||||
| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |||||
| Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) | |||||
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol | Name of each exchange on which registered | ||||||
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD.
On January 10, 2022, Landec Corporation, a Delaware corporation (the “Company”) will be presenting at the 2022 ICR Conference. A copy of the Company’s presentation materials (the “Presentation”) is attached hereto as Exhibit 99.1 and is incorporated by reference in this Item 7.01.
The foregoing information in this Item 7.01, including the information contained in the Presentation in Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings, whether made before or after the date hereof, regardless of any general incorporation language in any such filing
Item 9.01 Financial Statements and Exhibits.
(d) Exhibit.
The following exhibits are furnished as part of this report:
Exhibit No. | Description | ||||||||||||||||
104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. | ||||||||||||||||
2
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: January 10, 2022
LANDEC CORPORATION | |||||||||||
| By: | /s/ John D. Morberg | ||||||||||
John D. Morberg | |||||||||||
| Chief Financial Officer | |||||||||||
3
CONFIDENTIAL 1 Lifecore Biomedical Investor Presentation January 2022 Progress made www.lifecore.com possible (Nasdaq: LNDC)
This presentation 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”, "potential," "target," “expect”, “project”, “plan”, “intend”, “believe”, “may”, “might”, “will”, “should”, “can have”, “likely” and similar expressions are used to identify 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 timing and expenses associated with operations, the ability to achieve acceptance of the Company’s new products or obtain arrangements with new customers in the market place, the timing and ability to obtain regulatory approvals (including by us and our customers), government regulations affecting our business, the ability to maintain and grow existing client relationships and manage expenses, uncertainties related to COVID-19 and the impact of our responses to it. 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 our most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements represent management’s current expectations and are inherently uncertain. We do not undertake any obligation to update forward-looking statements made by us to reflect subsequent events or circumstances that may arise after the date of this presentation. Important Information Regarding Forward-Looking Statements 2
Lifecore Business Highlights Large, growing addressable markets with attractive underlying tailwinds supported by long-term customer relationships and low turnover 35+ years of exceptional quality, safety, and regulatory compliance with available capacity & state-of-the-art facilities to support future growth A leading provider of premium research grade HA with focus on complex and highly regulated products Highly experienced Lifecore management team with deep industry expertise and proven ability to execute Fully-integrated CDMO with highly differentiated capabilities for development and fill/finish of sterile, injectable-grade pharmaceutical products Aspirational goal to accelerate annual revenue growth into the mid- to high-teens based upon current pipeline characteristics and favorable industry tailwinds in the coming years Multiple levers to continue to drive long-term growth, including continued expansion and commercialization of development pipeline 3
Legacy Growth A leading supplier of pharmaceutical grade Hyaluronic acid (HA) in ophthalmology, orthopedic and veterinary medicines. A fully integrated Contract Development and Manufacturing Organization (CDMO) assisting companies to bring new and FDA-approved injectable therapies to market. Revenue Streams FY21 Total Revenues: $98.1M Lifecore Biomedical To provide high quality innovative product development and manufacturing solutions for our partners, guided by our unwavering commitment to improving people’s lives 77% 23% FY21 CDMO ~77% of Revenues CDMO HA Manufacturing Progress made possible 4 Continuing to invest in capabilities in the CDMO business to drive an acceleration in revenue growth
Growth Strategies 5 EXPANSION OF DEVELOPMENT PIPELINE AND COMMERCIAL SERVICES TARGET INCREASING OPERATIONAL CAPACITY • Invest in people and systems to support expanded development pipeline and services • Targeted sales and marketing strategy • Identify and expand development services portfolio • Identify late phase development and new commercial opportunities • Invest in people & systems to seek to maximize efficiencies and growth potential • Advance late phase development projects through commercialization • Advance early phase projects and support commercial growth of marketed products • Support commercial growth of base business • Identify strategic adjacencies and partnerships • Target increasing operational capacity to 22 million units by FY25 and 45 million units by FY28 1. 2. St ra te gi es
1983 First commercial sales of sodium hyaluronate (HA) 1981 Lifecore initiates sodium hyaluronate (HA) production 1986 First FDA approved product with Lifecore HA 1994 First Ophthalmic Aseptic Product 2021 FDA approval of 2 products manufactured at Lifecore Progress Made Possible Leveraging over 35 years of experience to bring our customers’ innovations to market 2024 Two (2) cGMP isolator fillers anticipated to be operational enabling expanded capacity 2005 Installed first automated syringe filler 2016 First FDA Drug Approval 10M units 6 16M units 22M units 45M unitsTheoretical Filling Capacity 5M units
State-Of-The-Art Manufacturing Sites Lifecore maintains two state-of-the-art facilities to support the development and manufacturing needs of our clients Four ISO 5 clean rooms with various fillers supported by five ISO 7 formulation rooms Invested $100M during the past 10 years and $58M over the last 3 years (FY20-22) in capital expenditures related to innovation, product development, facilities, equipment and new capabilities for the Lifecore business Lyman Boulevard Location 148,200 sq. ft. Lakeview Drive Location 80,950 sq. ft. Dedicated Development and Pilot Labs Lifecore also has an FDA approved warehouse site with 21,400sq. ft. Three analytical labs supporting development and commercial testing/stability 7
Extensive Regulatory Systems & Excellent Quality Record • Three sites operating under cGMP and regularly inspected • World class quality system leads to excellent regulatory record • ~80 customer audit days routinely held annually QMS Multi-Regulation Compliant 35+ years of a strong track record with global regulatory bodies; regularly inspected facilities are in good standing with agencies. API Excipient Medical Devices Biologic Products Drug Products 8
Highly Differentiated End-To-End Capabilities ✔ Global leader in Hyaluronic Acid (HA) manufacturing ✔ Research grade HA available in powder form supporting standard and custom modified options ✔ Services provided from early stage through validation/qualification ✔ Services range from formulation, process development, analytical method development, engineering and validation ✔ Expertise in sterile filter and aseptically fill of custom complex solutions ✔ Capabilities include drug product formulation, sterile filter, aseptic fill, visual inspection, analytical testing and stability services ✔ Packaging services featuring automated assembly, camera verification, serialization and tracking through supply chain, QA review and lot release A Pioneer in Developing and Manufacturing Highly Complex Solutions Hyaluronic Acid Clinical Development Services Commercial Manufacturing 9
Trusted Producer of Premium Pharmaceutical Injectable Grade Hyaluronic Acid Type of HA Quality General Uses & Types of Products Barriers to Competition Pharmaceutical Injectable grade High Governed by regulatory agencies ✔Ophthalmic surgery ✔Joint Injections ✔Bone grafts ✔Intra-articular injections ✔Carrier for drugs ✔Tissue engineering High • Product specs tailored to needs of end user • Heightened quality control in US/EU markets • Regulatory barriers to change source Topical Medical grade Moderate Governed by regulatory agencies with less restrictions • Eye drops • Topical wound healing • Topical medications • Intradermal injections Moderate Cosmetic Nutraceuticals Low Limited or no regulatory agency oversight • Cosmetics, lotions, creams • Nutraceuticals, supplements Low to None Commoditized C om plexity 10
Injectable Products Lead Growth in Drug Development Market SPECIALITY SOLID SEMISOLID & LIQUID INJECTABLE $6.02 Billion Injectable segment is expected to grow at 10.5% CAGR from 2020-2025* 11 • Equipment Differentiated & Unique • High Value Molecules • Technical Expertise Required Approximate CDMO market size - $22.6 Billion* *RBC Capital Markets, CDMO Sector Perspectives, July 1, 2021
Lifecore is in a strong position to accelerate growth Favorable Anticipated Trends Fuel Long-Term CDMO Demand & Value for Lifecore Growing injectable NDA approvals High propensity to outsource manufacturing among small & mid-sized organizations *(Pre-Clinical; Phase 1-3) 2008 – 2019 - William Blair, Pharmaceutical Outsourcing & Service Report. April 2020 **(Finished dose outsourced by small and mid-sized pharma) William Blair, Pharmaceutical Outsourcing & Service Report. April 2020 (Pharma size defined in revenues as follows: Small <$2.5Bn, Mid: >$2.5Bn & <$10Bn, Large: >$10Bn) *** Pharmaprojects® (January 2019 - 2023, as compared to injectable demand of +10%) ****GlobalData PharmSource Report: Demand and Supply for Contract Manufacturing of Injectable Drugs Through 2023 55% of all drugs in development are injectables +13% Anticipated CAGR*** 90-132**** Estimated new approvals of injectable therapies received by CDMOs between 2018 - 2023 75-100M units**** Anticipated incremental demand for specialized therapies in vials and syringes between 2019 and 2023 Drug development is on the rise +6% CAGR* Prefilled syringe demand is outpacing the injectable market (Pharmaprojects® January 2019) Demand for specialized CDMO vial & syringe capacity +75% of Total Approvals** 12
Long-Term, Blue Chip Customer Base Blue-chip customer base spans: Customers choose Lifecore: • Supports all phases of development and commercial lifecycle • Strong capabilities in manufacturing and supplying pharmaceutical-grade HA in bulk form and injectables • Technical expertise in high viscous solutions and infrastructure to support development of drugs, biologics, medical devices and combination products • Proven demonstration of sophisticated quality systems with a clean history • 13 commercial customers – global and emerging biopharma and biotech companies • 26 commercial products • Lifecore continues to expand its presence in the CDMO marketplace by utilizing its specialized capabilities to seek to partner with biopharma and medical device companies Customer 5 Customer 4 Customer 3 Customer 2 Customer 1 39 Years 5 Years 28 Years 18 Years 22 Years Top 5 Revenue Customers 13
Managing Our Pipeline Project Lifecycle CDMO Revenue Opportunities Lifecore can address customers’ entire development and commercial lifecycle *Projects are defined as individual drugs or devices for which Lifecore provides manufacturing services Phase 3Preclinical Phase 1 Phase 2 CommercialRegistration Commercial Manufacturing Proof of Concept Development Scale-Up 23 Projects* currently in various phases of development Early Phase: 5 Projects Mid Phase: 8 Projects Late Phase: 10 Projects Currently Manufacture 26 Commercial Products 14
Our Existing Project Breakdown Proof of Concept Development Development Scale-up Number of Projects 5 8 10 Anticipated Remaining Time to Commercialization* 3-10 years 2-8 years 1-4 years Therapeutic Area Ophthalmic, Metabolic disorders, Non-Opioid Pain Ophthalmic, Non-Opioid Pain, Aesthetic, Orthopedic, Oncology Ophthalmic, Respiratory, Veterinary, Non-Opioid Pain Drug or Device 3 Drugs, 2 Devices 6 Drugs, 2 Devices 7 Drugs, 3 Devices Customer Type 4 Large Pharma, 1 Small 1 Large Pharma, 1 Medium, 5 Small 1 Large Pharma, 1 Medium, 5 Small HA & Non HA 4 HA, 1 Non HA 6 HA, 2 Non HA 5 HA, 5 Non HA 15 * Anticipated remaining time to commercialization may be impacted by but not limited to such factors as regulatory timing, FDA approvals, contract negotiations, and capacity limitations. In addition, customers can elect not to pursue a relationship with Lifecore at any time during that process.
Revenue Potential of Scale-up Late-phase Projects Annual Product Revenue Potential # of Projects Annual Target Revenue Opportunity >$10 million 3 $30 – $75 million $5 – $10 million 2 $10 – $20 million <$5 million 5 $5 – $25 million 16 Note: Projects noted above are anticipated to commence between 1 and 4 years. The commercialization of these projects are subject to numerous conditions which may impact the timing and ultimate revenue generation for Lifecore.
Revenue ($ in millions) EBITDA Long History of Stable, Sustainable Growth in Commercial Revenue & EBITDA Attractive EBITDA margin profile with room for expansion as capacity utilization increases $40.4 $50.5 $59.4 $65.4 $75.9 $85.8 $98.1 FY15 FY16 FY17 FY18 FY19 FY20 FY21 *Temporary COVID impact 28.1% 27.6% 26.7% 26.7% 23.4%* 25.0%25.0% 17.6% 10.1% 16.1% 13% 14.3% 15.1%YoY Growth %: EBITDA Margin %: ($ in millions) $6.1 $14.2 $16.4 $17.5 $20.3 $20.1 $24.5 FY15 FY16 FY17 FY18 FY19 FY20 FY21 17
Plan to Increase Operational Capacity by FY25 0 5 10 15 20 25 FY21 FY25 Illustrative Capacity Growth: Near-Term Opportunity to Drive Capacity Utilization and Higher Fill Rates Units Filled (FY21 Actual; FY25 Target) C ap ac ity (M illi on s of u ni ts ) +100% vs. FY21 2. Theoretical target capacity of 22 million units represents fully staffed equipment capacity that is in place today 3. Current operational capacity of 10 million units which represents available capacity that is managed against known demand; seek to maintain utilization rates of ~80% of operational capacity Will require continued investment to build operational capacity to meet demand 1.Theoretical Capacity Operational Capacity 18 Available Capacity to Drive Growth
Our FY22 Outlook Guidance: FY22 vs FY21 $105mm - $108mm +7% - 10% $26mm - $27mm +6% - 10% Key Drivers & Activity 2. Expansion of the development project pipeline 3. Anticipated initial commercial revenues from ZYNRELEF® product 4. $32 million of anticipated capital investment in FY22 1. Investments in P&L (sales and marketing, development activities and resources) Revenue: EBITDA: 19 Aspirationally, Lifecore is looking to accelerate annual revenue growth into the mid- to high-teens, based on the current pipeline characteristics and industry tailwinds, in the coming years
Meet the Lifecore Team Highly Experienced Management Team with Deep Industry Expertise & Proven Ability to Execute Name James Hall John Morberg Jackie Klecker Darren Hieber Rick Sitarz Kipling Thacker, PhD Scott Collins Kara Morley Steve Laninga Position President, Lifecore CFO VP and General Manager VP of Corporate Development & Partnerships VP of Commercial Development Chief Scientific Officer and VP VP of Finance VP of Human Resources VP of Operations Joined Lifecore 1999 2021 2001 2021 2015 1981 2001 2021 2020 Years of Experience 30+ 30+ 30+ 20+ 20+ 40+ 20+ 20+ 20+ Prior Experience Served in various roles at Lifecore including VP and General Manager and VP of Operations Serves as Landec CFO Previously served in executive roles as CEO, CFO, General Counsel and Board Member of public and private companies Served in various roles at Lifecore surrounding Quality Assurance and Regulatory Affairs Previously served as VP of Business Development, Drug Product at Catalent Previously served as VP of Peripheral Interventions Marketing at Boston Scientific Co-inventor of Lifecore’s HA fermentation and mfg. process Previously served as Director of New Bustiness Development at Lifecore Previously served as Senior Director of Finance and Controller at Lifecore Previously served as VP of Human Resources at Werner Electric Previously served as VP of Operations and Site Lead at Perrigo 20
Lifecore Business Highlights Large, growing addressable markets with attractive underlying tailwinds supported by long-term customer relationships and low turnover 35+ years of exceptional quality, safety, and regulatory compliance with available capacity & state-of-the-art facilities to support future growth A leading provider of premium research grade HA with focus on complex and highly regulated products Highly experienced Lifecore management team with deep industry expertise and proven ability to execute Fully-integrated CDMO with highly differentiated capabilities for development and fill/finish of sterile, injectable-grade pharmaceutical products Aspirational goal to accelerate annual revenue growth into the mid- to high-teens based upon current pipeline characteristics and favorable industry tailwinds in the coming years Multiple levers to continue to drive long-term growth, including continued expansion and commercialization of development pipeline 21
Investment Highlights CONFIDENTIAL 22 Thank You CONFIDENTIAL Progress made www.lifecore.com possible