Willow Biosciences Inc (TSX:WLLW, OTCQB:CANSF) has reported results showing record revenue in 4Q and full-year ended December 31, 2022, and, separately, said it and SUANFARMA have completed the development and manufacturing process in pilot scale for Willow's ingredient, Cannabigerol (CBG).
For the year ended December 31, 2022, Willow reported full-year revenue of $821,000 and $510,000 for the fourth quarter, marking the highest level of revenue for any quarterly or fiscal year in its history.
The company also ended the quarter with strong liquidity, including approximately $15 million of cash and short-term investments while its approved annual budget is expected to be fully funded for 2023.
"Fiscal 2022 was a transformative year for Willow as we took significant steps to position the company for nearer term revenue creation, and more rapid and diversified commercial growth, all with a reduced cash burn," Dr Peter Seufer-Wasserthal, Willow's president and CEO said in the results statement.
READ: Willow Biosciences gives business outlook, key targeted milestones for 2023 to expand growth, recaps 2022 key milestones
"The result of these activities was our ability to successfully deliver on certain key milestones while posting the highest quarterly and annual revenue in the Company's history. We are proud of Willow's R&D team's dedication and execution and excited to showcase our capabilities in 2023 while delivering what we believe will be significant revenue growth and overall improved financial results,” he added.
Looking ahead, Willow currently expects significant revenue growth over 2022 and a reduction in cash burn as it moves to its goal of noted improvement in bottom-line financial results.
Quarterly highlights include:
- Transitioned to be well positioned for near-term revenue generation, while protecting its balance sheet and reducing cash burn. This resulted from significant steps Willow took to consolidate and centralize R&D operations to reduce overall costs, outsource its internal quality control analytical testing and release requirements and eliminate certain full-time employees.
- Willow continues to be on target for achieving its previously stated 2023 milestones
- First large-scale batch of Clinical Evaluation of CBG produced at the company's new CMO for existing and new customers.
- In March 2023, the company initiated its first large-scale pilot runs in support of upcoming commercial production batches.
- Based on existing data, expect attaining independent conclusion of generally recognized as safe for Willow's CBG. In February 2023, the company completed its pivotal 90-day oral toxicity studies showing Willow's CBG was safe at the tested dose levels. Additional details to be released in the near term.
- Anticipated milestone payments for technology transfer of the company's first two partnered projects.
- At least one new partnered development program for a functional ingredient.
- Astaxanthin strain wholly owned by Willow expected to be productive enough to start downstream process development.
Pilot scale manufacturing process
In a separate statement, Willow Biosciences said it and SUANFARMA have completed the development and manufacturing process in pilot scale for Willow-owned ingredient, Cannabigerol (CBG).
The 36 cubic metre scaling-up production batches required for the forthcoming qualification and registration will be completed during 2023. SUANFARMA's CIPAN manufacturing site has significant expertise as a Contract Development and Manufacturing Organisation (CDMO) in fermentation and purification technologies under the highest standards of quality.
The companies plan to broaden the relationship by offering an end-to-end synthetic biology solution and expanding their joint product portfolio. With this alliance, both companies will bring together their existing pharma and biotech capabilities for the production of ingredients, including anti-infectives and other Active Pharmaceutical Ingredients (APIs) and intermediates for Pharma and natural ingredients designed for the Health & Wellness and Food & Beverage industries.
"CIPAN has proven itself a highly capable manufacturing partner with the efficient scaling and production of our first ingredient, CBG. We are excited to broaden the collaboration further to both offer an end-to-end solution to our customers while also expanding the portfolio of products with SUANFARMA" Chris Savile, COO of Willow Biosciences, said in the statement.
"The development and piloting of this USP/DSP process in collaboration with Willow Biosciences is now completed and constitutes a very important milestone towards a robust, reliable, and efficient manufacturing process at industrial scale. This collaboration opens new business opportunities for both companies with important synergies," added Daniel Rivero, Industrial Director of Suanfarma.
SUANFARMA founded in 1993, is a B2B life science partner specialized in the development, production, and commercialization of ingredients for the pharmaceutical, veterinary and nutraceutical industries.
Willow develops and produces precision fermented functional ingredients for the health and wellness, food and beverage and personal care markets. Willow's FutureGrown biotechnology platform allows large-scale production with sustainability at its core. Willow's R&D team has a proven track record of developing and commercializing bio-based manufacturing processes and products to benefit our B2B partners and their customers.
Contact the author at jon.hopkins@proactiveinvestors.com