NEW YORK – Twist Bioscience said this week that it has experienced a series of interruptions to production over the last few months as it is planning to expand its DNA synthesis capacity next year.
The firm's fiscal fourth quarter operations were impacted by an "extraordinary event where we needed to shut down production for a short period of time," Twist cofounder and CEO Emily Leproust told investors on a conference call on Monday to discuss its financial results. "During [quality control], we identified unwanted DNA sequences included in our genes. None of these genes were shipped to customers, but we did experience a delay in some gene orders. We were able to successfully troubleshoot the issues, clear the resulting backlog in three weeks, and still reported robust orders for synbio in the quarter."
The hit to the firm's finances in fiscal Q4 was "roughly just under a million dollars, due mostly to having to do reruns," Twist CFO Jim Thorburn told investors.
In addition to the Q4 production issue, Twist suffered another interruption last month. "We were able to resolve [it] much more quickly, and we believe we have now identified the root cause and do not expect further interruptions in production," Leproust said. While she does not expect the issue — a combination of reagents and hardware — will cost the firm many customers, it "puts us on the back foot as we start the year," she noted.
The problems also highlight the firm's need for additional capacity, she said. The firm's "Factory of the Future," being built in Wilsonville, Oregon, outside of Portland, and expected to come online next year, should help, she said, but Twist now plans to add even more capacity at its existing Bay Area facility "to ensure we can meet demand from partners in the next 12 to 18 months."
By the end of this year, Twist will increase its production capacity to 80,000 genes per month, and by April 2022, it plans to be able to make 90,000 genes per month. Currently, the firm can make about 45,000 genes per month, Leproust said.
The manufacturing expansion is one of several plans the DNA synthesis firm announced this week.
For example, it plans to acquire antibody discovery services firm Abveris for up to $190 million in stock and cash, and to spin out its infectious disease antibody therapeutics business as Revelar Biotherapeutics. Leproust also teased plans to expand its NGS product lineup and continue to develop its biopharma business.
Twist saw record revenues for fiscal year 2021, totaling $132.3 million, a 47 percent increase year over year. The firm also guided for total revenues in the range of $173 million to $181 million, without the addition of Abveris, representing growth of about 34 percent at the midpoint of that range.
"We recognize we need to meet not only ongoing increase in demand but also any surges in demand when large gene orders arrive," Leproust said.
Company officials reiterated that the new manufacturing facility in Oregon would come online next year and ramp capacity around the fiscal fourth quarter. In a note to investors, JP Morgan analyst Tycho Peterson said that timeline was "slightly delayed from prior comments of mid-calendar year 2022." The firm expects to invest about $75 million over the next year to open the facility, Thorburn noted.
Investment will be a big theme for Twist in 2022. In addition to closing the Abveris deal, Twist could invest up to $10 million in Revelar.
The firm has licensed its lead bispecific antibody to treat COVID-19 to the spinout in a deal that includes milestone payments of up to $100 million and mid-single digit royalties on any commercial sales. The deal also provides for up to five additional, non-COVID-related programs with separate milestone and royalties terms.
"Building on data from a peer-reviewed publication in Science, Twist Biopharma optimized an antibody that neutralizes all known SARS-CoV-2 variants of concern,” Glenn Marina, CEO of Revelar, said in a statement. "We look forward to completing preclinical and chemistry, manufacturing, and control development in support of filing an investigational new drug application that supports the initiation of clinical studies." Leproust said she expects the antibody to appear in clinics sometime next year.
At the end of the fiscal year, Twist's biopharma division had 41 active programs with 34 partners, 35 of which have associated milestones and royalties.
The firm is also directing many resources to its DNA data storage program, which is "laying the groundwork" for an early-access offering after passing an IARPA, short for Intelligence Advanced Research Projects Activity, program test.
An IARPA team came to Twist with a set of DNA sequences to be synthesized on the firm's 1-micron proof-of-concept chip in a single day. "The sequences were not shared in advance, and we passed the test with flying colors," Leproust said. "In addition, we confirmed we can synthesize at individual sites with no cross-talk or spillover into adjacent sites. This was a critical technology demonstration that validates our ability to achieve smaller dimensions." The firm is now designing its alpha chip.
Elsewhere in the company, Twist is preparing for the commercial launch of high-throughput IgG antibodies for pharma customers and plans to expand its capabilities around RNA and library preparation as well as its original equipment manufacturing strategy. The firm also plans to license at least one Twist-discovered antibody and sign additional biopharma partnerships.