On March 22, 2022 MaxCyte, Inc., (NASDAQ: MXCT; LSE: MXCT) is a leading commercial cell-engineering company reported that focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization (Press release, MaxCyte, MAR 22, 2022, View Source [SID1234610593]). The Company reported fourth quarter and full year ended December 31, 2021 financial results and provided initial 2022 revenue guidance.

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Fourth Quarter and Year Highlights

Record quarterly revenue of $10.2 million up 19% over Q4 2020 was driven by strength in the core business; with growth in core business revenue from cell therapy customers of 43% and drug discovery customers of 32%.
Record full-year total revenue of $33.9 million, up 30% over 2020, which was driven by total growth in core business revenues of 37%. We generated a total of $2.5 million in SPL Program-related revenue for the full year 2021.
2022 initial guidance includes expectations for core revenue growth of 22% to 25% over 2021 and SPL Program-related revenue of approximately $4 million.
Conference call begins at 4:30 p.m. Eastern time today.
"We are pleased to report very strong fourth quarter and full year results driven by ongoing strength in sales to cell therapy customers," said Doug Doerfler, President and CEO of MaxCyte. "2021 was an excellent year at MaxCyte, as we completed our Nasdaq listing and made important and strategic investments in our business, which are ongoing. We continue to expand our customer base and increase the number of strategic partnerships, now with 16 SPL agreements in place following the announcement of our agreement with Intima Bioscience in February 2022. Overall, MaxCyte remains well-positioned to support growing adoption of the ExPERT platform technology for cellular-based research and next-generation therapeutic development."

The following table provides details regarding the sources of our revenue for the periods presented.

Three Months Ended Year Ended
December 31,
(Unaudited) December 31,
(Unaudited)
2021 2020 % 2021 2020 %
(in thousands, except percentages)
Cell therapy $ 7,264 $ 5,072 43 % $ 22,984 $ 15,769 46 %
Drug discovery 2,885 2,191 32 % 8,395 7,143 18 %
Program-related 3 1,252 (100 )% 2,515 3,257 (23 )%
Total revenue $ 10,152 $ 8,515 19 % $ 33,894 $ 26,169 30 %
Operational Highlights

With the addition of Myeloid Therapeutics, Inc., Celularity, Inc., Sana Biotechnology, Inc., and Nkarta, Inc. signed in 2021, and Intima Bioscience signed in early 2022, the total number of Strategic Platform Licenses (SPLs) signed with our cell therapy partners now stands at 16.
Our 16 active SPL partner agreements now allow an aggregate of over 95 potential programs; over 15% of these have entered in the clinic (defined as programs as with at least a cleared IND, or equivalent). If all allowed programs successfully progress though the clinic to commercial approval, we have the potential to generate pre-commercial milestones of over $1.25 billion before potential sales-based commercial revenue to MaxCyte. This compares to the update from the prior year (January 2021) of 12 SPLs covering over 75 programs (with total potential pre-commercial milestones exceeding $950 million), over 15% of which had entered the clinic.
We closed 2021 with over 500 instruments placed with customers, compared to over 400 instruments as of the end of 2020.
We successfully released the VLx under our ExPERT platform, our large-scale Flow Electroporation platform under the ExPERT brand; we have seen strong initial interest from prospects in using the VLx for large-scale bioprocessing applications.
Dr. Cenk Sumen, Ph.D. recently joined our team as Chief Scientific Officer. Dr Sumen was previously CTO at Stemson Therapeutics and holds a Ph.D. in Microbiology and Immunology from Stanford University, completed his post-doctoral training at Harvard and a fellowship at the Cancer Research Institute and worked at Memorial Sloan Kettering Cancer Center under Nobel Laureate Dr. Jim Allison.
We also launched three new processing assemblies (our single-use disposables), the R50x3, the R50x8 and the G1000, which were directly targeted to both research and GMP customer needs and contributed to our growth in fiscal 2021; particularly in the fourth quarter.
Finally, we are on track to move into our new corporate headquarters facility in 2022, which includes new office space, expanded applications and process development lab facilities, and more than tripling of our manufacturing space.
As of the dates presented, our key metrics described above were as follows:

As of December 31,
2021 2020* 2019
Installed base of instruments (sold or leased) >500 >400 >320
Number of active SPLs 15 12 8
Total number of licensed clinical programs (SPLs only) >95 >75 >55
Total number of licensed clinical programs under SPLs currently in the clinic ** >15% >15% >5%
Total potential pre-commercial milestones under SPLs >$1.25 billion >$950 million >$650 million
* Amounts presented as of December 31, 2020, give effect to one SPL entered into and additional INDs cleared in January 2021.

** Number of licensed clinical programs under SPLs are by number of product candidates and not by indication.

Fourth Quarter and Full Year 2021 Financial Results

Total revenue for the fourth quarter of 2021 was $10.2 million, compared to $8.5 million in the fourth quarter of 2020, representing growth of 19%. Revenue from cell therapy customers were collectively up 43% before program-related revenues compared to the same period last year.

Our SPL partners did not achieve any milestone events in the fourth quarter and thus there was no SPL Program-related revenue in the quarter, as compared to $1.3 million in SPL Program-related revenue in the fourth quarter of 2020.

Gross profit for the fourth quarter of 2021 was $8.9 million (88% gross margin), compared to $7.6 million (89% gross margin) in the same period of the prior year. The decrease in gross margin was driven by the lower SPL Program-related revenues; excluding SPL Program-related revenues, gross margin was relatively unchanged.

Operating expenses for the fourth quarter of 2021 were $13.9 million, compared to operating expenses of $10.0 million in the fourth quarter of 2020. The overall increase in operating expenses was primarily driven by increased headcount across all areas of the business and an increase in stock-based compensation.

Fourth quarter 2021 net loss was $4.9 million compared to net loss of $2.7 million for the same period in 2020; EBITDA, a non-GAAP measure, was a loss of $4.5 million for the fourth quarter 2021, compared to a loss of $2.3 million for the fourth quarter of prior year; stock-based compensation expense was $2.4 million versus $0.8 million for the same period in the prior year.

Full Year Financial Results

Total revenue for 2021 was $33.9 million, compared to $26.2 million in 2020, representing growth of 30%. The increase was primarily driven by growth in sales and licenses of instruments and sales of disposables to cell therapy customers.

The Company recognized $2.5 million in SPL Program-related revenue during 2021 (comprised of pre-commercial milestone revenues) as compared to $3.3 million in SPL Program-related revenue in 2020.

Gross profit for 2021 was $30.2 million (89% gross margin), compared to $23.4 million (89% gross margin) in the prior year.

Operating expenses for 2021 were $48.4 million, compared to operating expenses of $34.5 million in 2020. The overall increase in operating expenses was principally driven by an increase in expenses associated with increased headcount, increased stock-based compensation, and increased expenses due to our recent NASDAQ public listing. Partially offsetting this expense increase was a $5.8 million decline in CARMA-related expenses compared with last year. The Company had no material CARMA related expenses after March 2021.

Full year 2021 net loss was $19.1 million compared to a loss of $11.8 million in 2020; full year 2021 EBTIDA was a loss of $17.4 million versus a loss of $10.4 million for the prior year; total stock-based compensation for the full year was $8.0 million versus $2.5 million for the prior year.

Total cash, cash equivalents and short-term investments were $255.0 million as of December 31, 2021.

2022 Revenue Guidance

Management is providing initial 2022 revenue guidance based on our expectations for the existing business.

We expect revenue from our core business (instruments and disposables to cell therapy and drug discovery customers) to grow between 22% and 25% over 2021. We also expect SPL Program-related revenue to be approximately $4 million in 2022.

We intend to provide more context for the trajectory of our SPL Program-related revenue on the earnings call (details below).

Webcast and Conference Call Details

MaxCyte will host a conference call today, March 22, 2022, at 4:30 p.m. Eastern Time. Interested parties may access the live teleconference by dialing (844) 679-0933 for domestic callers, (918) 922-6914 for international callers, for 0203 1070 289 U.K domestic callers, or for 0800 0288 438 U.K. international callers followed by Conference ID: 2675034. A live and archived webcast of the event will be available on the "Events" section of the MaxCyte website at View Source

Non-GAAP Financial Measures

This press release contains EBITDA, which is a non-GAAP measure defined as net loss excluding depreciation, amortization, income tax (benefit) expense and net interest expense. MaxCyte believes that EBITDA provides useful information to management and investors relating to its results of operations. The company’s management uses this non-GAAP measure to compare the company’s performance to that of prior periods for trend analyses, and for budgeting and planning purposes. The company believes that the use of EBITDA provides an additional tool for investors to use in evaluating ongoing operating results and trends and in comparing the company’s financial measures with other companies, many of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics used by management in its financial and operational decision-making.

Management does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded in the company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but should not be considered a substitute for, or superior to, GAAP results. A reconciliation tables of the net loss, the most comparable GAAP financial measure to EBITDA, is included at the end of this release. MaxCyte urges investors to review the reconciliation and not to rely on any single financial measure to evaluate the company’s business.