Sana Biotechnology, Inc. (NASDAQ: SANA), a company focused on
creating and delivering engineered cells as medicines, today
reported financial results and business highlights for the third
quarter of 2021.
“We continue to make progress in building the company,
progressing our pipeline, and growing our people and capabilities,”
said Steve Harr, Sana’s President and Chief Executive Officer. “The
recent licensing of genome editing technology to enable multiple
pipeline programs is an example of our continued focus on
augmenting our innovative capacity. As our pipeline progresses, we
look forward to presenting data from our in vivo CAR T and ex vivo
allogeneic CAR T cell programs at the upcoming 63rd American
Society of Hematology (ASH) Annual Meeting & Exposition in
December.”
Recent Corporate Highlights
- Announced an agreement for non-exclusive commercial rights to
Beam’s CRISPR Cas12b nuclease system for certain ex vivo engineered
cell therapy programs. Engineering cells for therapeutic
applications requires technologies for precise editing of their
genome sequence. We plan to use the technology with certain product
candidates, including many of our allogeneic CAR T and pluripotent
stem cell programs.
Third Quarter 2021 Financial Results
GAAP Results
- Cash Position: Cash, cash equivalents, and
marketable securities as of September 30, 2021 were $866.1 million
compared to $412.0 million as of December 31, 2020, an increase of
$454.1 million. The increase was primarily driven by net proceeds
of $626.4 million received in Sana’s initial public offering in
February 2021, partially offset by cash used in operations of
$141.0 million and cash used for the purchase of property and
equipment of $24.7 million.
- Research and Development Expenses: For the
three and nine months ended September 30, 2021, research and
development expense, inclusive of non-cash expenses, was $53.2
million and $140.2 million, respectively, compared to $40.1 million
and $96.5 million, respectively, for the same periods in 2020. The
increases of $13.1 million and $43.6 million, respectively, for the
three and nine months ended September 30, 2021 were due to an
increase in personnel expenses related to increased headcount to
expand Sana’s research and development capabilities, costs for
laboratory supplies, costs for preclinical studies and external
manufacturing, and facility costs. Research and development
expenses include non-cash stock-based compensation of $4.1 million
and $9.9 million, respectively, for the three and nine months ended
September 30, 2021 and $1.0 million and $2.6 million, respectively,
for the same periods in 2020.
- Research and Development Related Success Payments and
Contingent Consideration: For the three and nine months
ended September 30, 2021, we recognized non-cash expenses of $16.8
million and $67.8 million, respectively, in connection with the
change in the estimated fair value of the success payment
liabilities and contingent consideration, compared to $4.5 million
and $57.3 million, respectively, for the same periods in 2020.
- General and Administrative Expenses: General
and administrative expenses for the three and nine months ended
September 30, 2021, inclusive of non-cash expenses, were $13.4
million and $37.7 million, respectively, compared to $7.1 million
and $19.1 million, respectively, for the same periods in 2020. The
increases of $6.3 million and $18.6 million, respectively, in the
three and nine months ended September 30, 2021 were primarily due
to increased personnel-related expenses attributable to an increase
in headcount to build our infrastructure, legal fees to support our
patent portfolio and license arrangements, insurance associated
with being a public company, consulting fees, and facility costs.
General and administrative expenses include stock-based
compensation of $1.9 million and $5.2 million, respectively, for
the three and nine months ended September 30, 2021 and $0.2 million
and $0.5 million, respectively, for the same periods in 2020.
- Net Loss: Net loss for the three and nine
months ended September 30, 2021 were $83.3 million, or $0.46 per
share, and $245.2 million, or $1.53 per share, respectively,
compared to $51.5 million, or $3.76 per share, and $172.1 million,
or $14.05 per share, respectively, for the same periods in
2020.
Non-GAAP Measures
- Non-GAAP Operating Cash Burn: Non-GAAP
operating cash burn for the nine months ended September 30, 2021
was $146.4 million compared to $87.2 million for the nine months
September 30, 2020. Non-GAAP operating cash burn is the decrease in
cash, cash equivalents, and marketable securities excluding cash
inflows from financing activities, cash outflows from business
development activities, and the purchase of property and
equipment.
- Non-GAAP Research and Development Expenses:
Non-GAAP research and development expenses for the three and nine
months ended September 30, 2021 were $53.2 million and $140.1
million, respectively, compared to $31.6 million and $86.5 million,
respectively, for the same periods in 2020. Non-GAAP research and
development expenses excludes one-time costs to acquire
technology.
- Non-GAAP Net Loss: Non-GAAP net loss for the
three and nine months ended September 30, 2021 was $66.5 million,
or $0.37 per share, and $177.4 million, or $1.11 per share,
respectively, compared to $38.5 million, or $2.81 per share, and
$104.9 million, or $8.56 per share, respectively, for the same
periods in 2020. Non-GAAP net loss exclude one-time costs to
acquire technology and non-cash expenses related to the change in
the estimated fair value of contingent consideration and success
payment liabilities.
A discussion of non-GAAP measures, including a reconciliation of
GAAP and non-GAAP measures, is presented below under “Non-GAAP
Financial Measures.”
About Sana
Sana Biotechnology, Inc. is focused on creating and delivering
engineered cells as medicines for patients. We share a vision of
repairing and controlling genes, replacing missing or damaged
cells, and making our therapies broadly available to patients. We
are more than 350 people working together to create an enduring
company that changes how the world treats disease. Sana has
operations in Seattle, Cambridge, and South San Francisco.
Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements about
Sana Biotechnology, Inc. (the “Company,” “we,” “us,” or “our”)
within the meaning of the federal securities laws, including those
related to the Company’s vision, progress, and business plans;
expectations for its development programs, product candidates and
technology platforms, including its pre-clinical, clinical and
regulatory development plans; the Company’s participation in the
63rd ASH Annual Meeting and Exposition and the subject matter of
the Company’s presentation at that meeting; and the Company’s plans
and expectations with respect to the use and utility of Beam’s
CRISPR Cas12b nuclease system for Sana’s ex vivo engineered cell
programs. All statements other than statements of historical facts
contained in this press release, including, among others,
statements regarding the Company’s strategy, expectations, cash
runway and future financial condition, future operations, and
prospects, are forward-looking statements. In some cases, you can
identify forward-looking statements by terminology such as “aim,”
“anticipate,” “assume,” “believe,” “contemplate,” “continue,”
“could,” “design,” “due,” “estimate,” “expect,” “goal,” “intend,”
“may,” “objective,” “plan,” “positioned,” “potential,” “predict,”
“seek,” “should,” “target,” “will,” “would” and other similar
expressions that are predictions of or indicate future events and
future trends, or the negative of these terms or other comparable
terminology. The Company has based these forward-looking statements
largely on its current expectations, estimates, forecasts and
projections about future events and financial trends that it
believes may affect its financial condition, results of operations,
business strategy and financial needs. In light of the significant
uncertainties in these forward-looking statements, you should not
rely upon forward-looking statements as predictions of future
events. These statements are subject to risks and uncertainties
that could cause the actual results to vary materially, including,
among others, the risks inherent in drug development such as those
associated with the initiation, cost, timing, progress and results
of the Company’s current and future research and development
programs, preclinical and clinical trials, as well as the economic,
market and social disruptions due to the ongoing COVID-19 public
health crisis. For a detailed discussion of the risk factors that
could affect the Company’s actual results, please refer to the risk
factors identified in the Company’s SEC reports, including but not
limited to its Annual Report on Form 10-K dated March 24, 2021 and
Quarterly Report on Form 10-Q dated November 8, 2021. Except as
required by law, the Company undertakes no obligation to update
publicly any forward-looking statements for any reason.
Investor Relations:Nicole Keithinvestor.relations@sana.com
Media:Morgan Warners, Finsbury Glover Heringmedia@sana.com
Sana Biotechnology,
Inc.Unaudited Selected Consolidated Balance Sheet
Data
|
|
September 30, 2021 |
|
|
December 31, 2020 |
|
|
|
(in thousands) |
|
Cash, cash equivalents, and marketable securities |
|
$ |
866,112 |
|
|
$ |
411,995 |
|
Total assets |
|
|
1,232,751 |
|
|
|
730,296 |
|
Contingent consideration |
|
|
131,981 |
|
|
|
121,901 |
|
Success payment
liabilities |
|
|
134,192 |
|
|
|
76,494 |
|
Total liabilities |
|
|
402,666 |
|
|
|
298,583 |
|
Convertible preferred
stock |
|
|
- |
|
|
|
852,897 |
|
Total stockholders' equity
(deficit) |
|
|
830,085 |
|
|
|
(421,184 |
) |
|
|
|
|
|
|
|
|
|
Sana Biotechnology,
Inc.Unaudited Consolidated Statements of
Operations
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
(in thousands, except per share data) |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
53,245 |
|
|
$ |
40,056 |
|
|
$ |
140,121 |
|
|
$ |
96,453 |
|
Research and development related success payments and contingent
consideration |
|
|
16,753 |
|
|
|
4,489 |
|
|
|
67,778 |
|
|
|
57,309 |
|
General and administrative |
|
|
13,433 |
|
|
|
7,099 |
|
|
|
37,731 |
|
|
|
19,063 |
|
Total operating expenses |
|
|
83,431 |
|
|
|
51,644 |
|
|
|
245,630 |
|
|
|
172,825 |
|
Loss from operations |
|
|
(83,431 |
) |
|
|
(51,644 |
) |
|
|
(245,630 |
) |
|
|
(172,825 |
) |
Interest income, net |
|
|
158 |
|
|
|
148 |
|
|
|
409 |
|
|
|
622 |
|
Other income, net |
|
|
10 |
|
|
|
44 |
|
|
|
24 |
|
|
|
68 |
|
Net loss |
|
$ |
(83,263 |
) |
|
$ |
(51,452 |
) |
|
$ |
(245,197 |
) |
|
$ |
(172,135 |
) |
Net loss per common share -
basic and diluted |
|
$ |
(0.46 |
) |
|
$ |
(3.76 |
) |
|
$ |
(1.53 |
) |
|
$ |
(14.05 |
) |
Weighted-average number of
common shares - basic and diluted |
|
|
181,827 |
|
|
|
13,680 |
|
|
|
160,515 |
|
|
|
12,249 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sana Biotechnology,
Inc.Changes in the Estimated Fair Value of Success
Payments and Contingent Consideration
|
|
Success
PaymentLiability(1) |
|
|
ContingentConsideration(2) |
|
|
Total Success Payment Liability and Contingent
Consideration |
|
|
|
(in thousands) |
|
Liability balance as of December 31, 2020 |
|
$ |
76,494 |
|
|
$ |
121,901 |
|
|
$ |
198,395 |
|
Changes in fair value - expense (gain) |
|
|
115,657 |
|
|
|
11,393 |
|
|
|
127,050 |
|
Liability balance as of March
31, 2021 |
|
|
192,151 |
|
|
|
133,294 |
|
|
|
325,445 |
|
Changes in fair value - expense (gain) |
|
|
(83,188 |
) |
|
|
7,163 |
|
|
|
(76,025 |
) |
Liability balance as of June
30, 2021 |
|
|
108,963 |
|
|
|
140,457 |
|
|
|
249,420 |
|
Changes in fair value - expense (gain) |
|
|
25,229 |
|
|
|
(8,476 |
) |
|
|
16,753 |
|
Liability balance as of
September 30, 2021 |
|
$ |
134,192 |
|
|
$ |
131,981 |
|
|
$ |
266,173 |
|
Total change in fair value for
the nine months ended September 30, 2021 |
|
$ |
57,698 |
|
|
$ |
10,080 |
|
|
$ |
67,778 |
|
(1) |
Cobalt Biomedicine, Inc. (Cobalt)
and the Presidents of Harvard College (Harvard) are entitled to
success payments pursuant to the terms of their agreements. The
success payments are recorded at fair value and remeasured at each
reporting period with changes in the estimated fair value recorded
in research and development related success payments and contingent
consideration on the statement of operations. |
(2) |
Cobalt is entitled to contingent
consideration upon the achievement of certain milestones pursuant
to the terms of the agreement. Contingent consideration is recorded
at fair value and remeasured at each reporting period with changes
in the estimated fair value recorded in research and development
related success payments and contingent consideration on the
statement of operations. |
|
|
Non-GAAP Financial Measures
To supplement the financial results presented in accordance with
generally accepted accounting principles in the United States
(GAAP), Sana uses certain non-GAAP financial measures to evaluate
its business. Sana’s management believes that these non-GAAP
financial measures are helpful in understanding Sana’s financial
performance and potential future results, as well as providing
comparability to peer companies and period over period. In
particular, Sana’s management utilizes non-GAAP operating cash
burn, non-GAAP research and development expense and non-GAAP net
loss and net loss per share. Sana believes the presentation of
these non-GAAP measures provides management and investors greater
visibility into the Company’s ongoing actual costs to operate its
business, including actual research and development costs
unaffected by non-cash valuation changes and one-time expenses for
acquiring technology, as well as facilitating a more meaningful
comparison of period-to-period activity. Sana excludes these items
because they are highly variable from period to period and, in
respect of the non-cash expenses, provides investors with insight
into the actual cash investment in the development of its
therapeutic programs and platform technologies.
These are not meant to be considered in isolation or as a
substitute for comparable GAAP measures and should be read in
conjunction with Sana’s financial statements prepared in accordance
with GAAP. These non-GAAP measures differ from GAAP measures with
the same captions, may be different from non-GAAP financial
measures with the same or similar captions that are used by other
companies, and do not reflect a comprehensive system of accounting.
Sana’s management uses these supplemental non-GAAP financial
measures internally to understand, manage, and evaluate Sana’s
business and make operating decisions. In addition, Sana’s
management believes that the presentation of these non-GAAP
financial measures is useful to investors because they enhance the
ability of investors to compare Sana’s results from period to
period and allows for greater transparency with respect to key
financial metrics Sana uses in making operating decisions. The
following are reconciliations of GAAP to non-GAAP financial
measures:
Sana Biotechnology,
Inc.Unaudited Reconciliation of Change in Cash,
Cash Equivalents, and Marketable Securities
to Non-GAAP Operating Cash Burn
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(in thousands) |
|
Beginning cash, cash equivalents, and marketable securities |
|
$ |
411,995 |
|
|
$ |
138,982 |
|
Ending cash, cash equivalents,
and marketable securities |
|
|
866,112 |
|
|
|
459,070 |
|
Change in cash, cash
equivalents, and marketable securities |
|
|
454,117 |
|
|
|
320,088 |
|
Cash paid to purchase property and equipment |
|
|
24,660 |
|
|
|
14,606 |
|
Change in cash, cash
equivalents, and marketable securities, excluding capital
expenditures |
|
|
478,777 |
|
|
|
334,694 |
|
Adjustments: |
|
|
|
|
|
|
|
|
Cash paid to acquire technology(1) |
|
|
1,246 |
|
|
|
7,650 |
|
Cash paid to satisfy contingent liability(2) |
|
|
- |
|
|
|
6,000 |
|
Net proceeds received from the initial public offering of common
stock |
|
|
(626,405 |
) |
|
|
- |
|
Net cash received from the sale of convertible preferred stock |
|
|
- |
|
|
|
(435,538 |
) |
Operating cash burn -
Non-GAAP |
|
$ |
(146,382 |
) |
|
$ |
(87,194 |
) |
(1) |
The non-GAAP adjustment of $1.2
million for the nine months ended September 30, 2021 was the
holdback payment related to the acquisition of Cytocardia, Inc. in
November 2019. The non-GAAP adjustment of $7.7 million for the nine
months ended September 30, 2020 was the upfront expense related to
the acquisition of Oscine Corp. in September 2020. |
(2) |
The non-GAAP adjustment of $6.0
million for the nine months ended September 30, 2020 was the
payment of a contingent liability due to Harvard in connection with
the closing of the Series B convertible preferred stock
financing. |
|
|
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Research and Development Expense
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
(in thousands) |
|
Research and development expense - GAAP |
|
$ |
53,245 |
|
|
$ |
40,056 |
|
|
$ |
140,121 |
|
|
$ |
96,453 |
|
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs to acquire technology(1) |
|
|
- |
|
|
|
(8,500 |
) |
|
|
- |
|
|
|
(8,500 |
) |
Change in the estimated fair value of contingent liability(2) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(1,443 |
) |
Research and development
expense - Non-GAAP |
|
$ |
53,245 |
|
|
$ |
31,556 |
|
|
$ |
140,121 |
|
|
$ |
86,510 |
|
(1) |
The non-GAAP adjustment of $8.5 million for the three and nine
months ended September 30, 2020 was the upfront expense recorded in
connection with the acquisition of Oscine Corp. in September
2020. |
(2) |
The contingent liability was recorded in connection with the
Harvard license agreement and paid in June 2020. |
|
|
Sana Biotechnology,
Inc.Unaudited Reconciliation of GAAP to Non-GAAP
Net Loss and Net Loss Per Share
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
|
|
(in thousands, except per share data) |
|
Net loss - GAAP |
|
$ |
(83,263 |
) |
|
$ |
(51,452 |
) |
|
$ |
(245,197 |
) |
|
$ |
(172,135 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs to acquire technology(1) |
|
|
- |
|
|
|
8,500 |
|
|
|
- |
|
|
|
8,500 |
|
Change in the estimated fair value of the success payment
liabilities(2) |
|
|
25,229 |
|
|
|
2,156 |
|
|
|
57,698 |
|
|
|
40,637 |
|
Change in the estimated fair value of contingent
consideration(3) |
|
|
(8,476 |
) |
|
|
2,333 |
|
|
|
10,080 |
|
|
|
16,672 |
|
Change in the estimated fair value of contingent liability(4) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,443 |
|
Net loss - Non-GAAP |
|
$ |
(66,510 |
) |
|
$ |
(38,463 |
) |
|
$ |
(177,419 |
) |
|
$ |
(104,883 |
) |
Net loss per share - GAAP |
|
$ |
(0.46 |
) |
|
$ |
(3.76 |
) |
|
$ |
(1.53 |
) |
|
$ |
(14.05 |
) |
Adjustments: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Costs to acquire technology(1) |
|
|
- |
|
|
|
0.62 |
|
|
|
- |
|
|
|
0.69 |
|
Change in the estimated fair value of the success payment
liabilities(2) |
|
|
0.14 |
|
|
|
0.16 |
|
|
|
0.36 |
|
|
|
3.32 |
|
Change in the estimated fair value of contingent
consideration(3) |
|
|
(0.05 |
) |
|
|
0.17 |
|
|
|
0.06 |
|
|
|
1.36 |
|
Change in the estimated fair value of contingent liability(4) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
0.12 |
|
Net loss per share -
Non-GAAP |
|
$ |
(0.37 |
) |
|
$ |
(2.81 |
) |
|
$ |
(1.11 |
) |
|
$ |
(8.56 |
) |
Weighted-average shares
outstanding - basic |
|
|
181,827 |
|
|
|
13,680 |
|
|
|
160,515 |
|
|
|
12,249 |
|
(1) |
The cost to acquire technology of
$8.5 million was the upfront expense recorded in connection with
the acquisition of Oscine Corp. in September 2020. |
(2) |
For the three and nine months
ended September 30, 2021, the expenses related to the Cobalt
success payment liability were $21.8 million and $46.9 million,
respectively, and $1.3 million and $35.2 million, respectively, for
the same periods in 2020. For the three and nine months ended
September 30, 2021 the expenses related to the Harvard success
payment liability were $3.4 million and $10.8 million,
respectively, and $0.8 million and $5.5 million, respectively, for
the same periods in 2020. The increase in expense for the Cobalt
and Harvard success payments for the three and nine months ended
September 30, 2021 were due to changes in our market capitalization
and common stock price during the relative periods. |
(3) |
The contingent consideration was
recorded in connection with the acquisition of Cobalt. The change
in value of the contingent consideration was primarily due to
scientific progress toward the achievement of milestones during the
relative periods. In addition, the discount rate used in the
calculation increased, which contributed to the decline in value
for the three months ended September 30, 2021. |
(4) |
The contingent liability was
recorded in connection with the Harvard license agreement and paid
in June 2020. |
Sana Biotechnology (NASDAQ:SANA)
Historical Stock Chart
From Jun 2024 to Jul 2024
Sana Biotechnology (NASDAQ:SANA)
Historical Stock Chart
From Jul 2023 to Jul 2024