Translate Bio Announces Second Quarter 2021 Financial Results and Provides Corporate Update
August 05 2021 - 5:11PM
Translate Bio (Nasdaq: TBIO), a clinical-stage messenger RNA (mRNA)
therapeutics company developing a new class of potentially
transformative medicines to treat or prevent debilitating or
life-threatening diseases, today announced financial results for
the second quarter ended June 30, 2021 and reviewed recent
corporate updates.
“Since we started our partnership with Sanofi in 2018, we have
moved two mRNA vaccine candidates through preclinical development
to investigational new drug (IND) application submission, and
initiated Phase 1 clinical trials for COVID-19 and seasonal
influenza. We have made significant progress in the development of
our mRNA vaccines through this collaboration, demonstrating some of
the key attributes of our mRNA platform, including speed,
flexibility and scale,” said Ronald Renaud, chief executive
officer, Translate Bio. “This transaction is a validation of our
mRNA platform and a testament to the talented Translate Bio team.
Joining Sanofi will deepen our existing relationship, and we
believe it will strengthen the team’s ability to bring innovative
and life-changing medicines to patients. Sanofi’s diverse
therapeutics portfolio can also further demonstrate the advantages
of our technology in areas beyond vaccines, building on the
pioneering work done over the last 10+ years at Translate Bio.”
Second Quarter 2021 and Recent Updates
mRNA Vaccine Programs for Infectious Diseases (Sanofi
Pasteur Collaboration)
- Initiated seasonal influenza mRNA vaccine clinical
trial (MRT5400 and MRT5401) with Sanofi Pasteur: In June
2021, the Company announced the start of the Phase 1 clinical trial
for MRT5400 and MRT5401, two formulations of a monovalent seasonal
influenza mRNA vaccine. The Phase 1 clinical trial will inform the
next steps of the mRNA-based influenza vaccine program. Interim
results from this trial are expected by the end of 2021.
- Achieved influenza manufacturing milestone: In
June 2021, the Company achieved a manufacturing milestone under the
collaboration with Sanofi Pasteur related to its influenza mRNA
vaccine program. Translate Bio received a $50 million payment from
Sanofi Pasteur for the successful manufacture, release and delivery
of clinical drug product to supply the Phase 1 seasonal influenza
clinical trial.
mRNA Therapeutics Programs
- Generated positive preclinical data for next-generation
CF program: Data demonstrates CFTR protein expression in
the lungs of animals after the delivery of the next-generation CF
product candidate using the intended inhaled route of
administration.
- Presented positive preclinical PCD data at the American
Thoracic Society (ATS) 2021 International Conference: In
May 2021, the Company presented positive results from a preclinical
study of a novel mRNA-based therapeutic designed to treat PCD. The
study results suggest that delivery of an mRNA-based therapeutic to
the lungs can lead to the expression of DNAI1, which could
potentially restore mucociliary clearance.
Second Quarter 2021 Financial Results and Financial
Guidance
Translate Bio ended the second quarter of 2021 with $667.2
million in cash, cash equivalents and investments and 75,343,712
shares of common stock outstanding.
Translate Bio reported a net income of $17.1 million for the
three months ended June 30, 2021, compared to a net loss of $36.3
million for the same period in 2020.
Collaboration revenue was $72.6 million and $16.3 million for
the three months ended June 30, 2021 and 2020, respectively.
Revenue was derived from the collaboration with Sanofi and is
recorded as a percentage of the estimated transaction price based
on the extent of progress toward completion. The transaction price
increased in the three months ended June 30, 2021 compared to the
same period in 2020 which resulted in an increase in revenue.
Operating expenses for the three months ended June 30, 2021 were
$56.6 million, compared to $53.0 million for the same period in
2020, and were comprised of the following:
- Research and development expenses of $40.5 million during the
second quarter of 2021, compared to $29.0 million for the same
period in 2020. The increase is primarily due to continued
development of the Company’s discovery program as well as increases
in occupancy and personnel-related costs.
- General and administrative expenses of $11.9 million during the
second quarter of 2021, compared to $8.6 million for the same
period in 2020. The increase is primarily due to increases in
personnel-related costs and professional fees.
- Operating expenses of $4.2 million for change in the fair value
of contingent consideration related to future potential milestone
and earnout payment obligations. The operating expense was
primarily attributed to an increase in the fair value of the
contingent consideration liability due to the time value of money
due to the passage of time and a decrease in the discount
rate.
About Translate BioTranslate Bio is a
clinical-stage mRNA therapeutics company developing a new class of
potentially transformative medicines to treat diseases caused by
protein or gene dysfunction, or to prevent infectious diseases by
generating protective immunity. Translate Bio is primarily focused
on applying its technology to treat pulmonary diseases with a lead
pulmonary candidate being evaluated as an inhaled treatment for
cystic fibrosis (CF) in a Phase 1/2 clinical trial. Additional
pulmonary diseases are being evaluated in discovery-stage research
programs that utilize a proprietary lung delivery platform.
Translate Bio also believes its technology may apply broadly to a
wide range of diseases, including diseases that affect the liver.
Additionally, the platform may be applied to various classes of
treatments, such as therapeutic antibodies or protein degradation.
Translate Bio is also pursuing the development of mRNA vaccines for
infectious diseases under a collaboration with Sanofi Pasteur. For
more information about the Company, please visit
www.translate.bio or on Twitter at @TranslateBio.
Cautionary Note Regarding Forward-Looking
StatementsThis press release contains forward-looking
statements within the meaning of The Private Securities Litigation
Reform Act of 1995. Such forward-looking statements include, but
are not limited to, those regarding: Translate Bio’s
expectations with respect to its collaboration with Sanofi Pasteur,
including the anticipated reporting of interim data from influenza
vaccine clinical trials in the second half of 2021, and the
development of mRNA vaccines and the delivery of infectious
vaccines globally; Translate Bio’s plans to advance its
additional disease programs and platform, strengthen its team’s
internal capabilities; Translate Bio’s beliefs regarding the broad
applicability of its MRT platform; and Translate Bio’s plans,
strategies and prospects for its business, including its lead
development programs. The words “anticipate,” “believe,”
“continue,” “could,” “estimate,” “expect,” “intend,” “may,”
“milestone,” “plan,” “potential,” “predict,” “project,” “should,”
“target,” “would” and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Such statements are
subject to numerous important factors, risks and uncertainties that
may cause actual events or results to differ materially from
current expectations and beliefs, including but not limited
to: risks related to Sanofi’s and Translate Bio’s ability to
complete the proposed acquisition on the proposed terms or on the
proposed timeline, including the receipt of required regulatory
approvals, the possibility that competing offers will be made,
other risks associated with executing business combination
transactions; disruption from the proposed acquisition making it
more difficult to conduct business as usual or to maintain
relationships with customers, employees, manufacturers, suppliers
or patient groups; Translate Bio’s ability to advance the
development of its platform and programs under the timelines it
projects, demonstrate the requisite safety and efficacy of its
product candidates and replicate in clinical trials any positive
findings from preclinical studies; the successful advancement of
the collaboration agreement between Translate Bio and Sanofi
Pasteur; uncertainties relating to the discovery and development of
therapies and vaccine candidates based on mRNA; the content and
timing of decisions made by the FDA, other regulatory
authorities and investigational review boards at clinical trial
sites, including decisions as it relates to ongoing and planned
clinical trials; Translate Bio’s ability to obtain, maintain and
enforce necessary patent and other intellectual property
protection; the availability of significant cash required to fund
operations; competitive factors; general economic and market
conditions; the current and potential future impacts of the
COVID-19 pandemic on the Company’s business, financial condition,
operations and liquidity and other important risk factors set forth
under the caption “Risk Factors” in Translate Bio’s Quarterly
Report on Form 10-Q for the quarterly period ended June 30, 2021
filed with the Securities and Exchange Commission on August 5, 2021
and in any other subsequent filings made by Translate Bio. Any
forward-looking statements contained in this press release speak
only as of the date hereof, and Translate Bio specifically
disclaims any obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
Contacts for Translate Bio |
|
|
|
Investors |
Media |
Teri Dahlman |
Maura Gavaghan |
tdahlman@translate.bio |
mgavaghan@translate.bio |
TRANSLATE
BIO, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue |
|
$ |
72,649 |
|
$ |
16,319 |
|
|
$ |
107,249 |
|
|
$ |
20,974 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
40,477 |
|
|
29,002 |
|
|
|
81,617 |
|
|
|
50,442 |
|
General and administrative |
|
|
11,921 |
|
|
8,601 |
|
|
|
22,738 |
|
|
|
16,060 |
|
Change in fair value of contingent consideration |
|
|
4,242 |
|
|
15,347 |
|
|
|
(39,737 |
) |
|
|
5,895 |
|
Total operating expenses |
|
|
56,640 |
|
|
52,950 |
|
|
|
64,618 |
|
|
|
72,397 |
|
Income
(loss) from operations |
|
|
16,009 |
|
|
(36,631 |
) |
|
|
42,631 |
|
|
|
(51,423 |
) |
Other
income, net |
|
|
154 |
|
|
343 |
|
|
|
308 |
|
|
|
853 |
|
Income
(loss) before income taxes |
|
|
16,163 |
|
|
(36,288 |
) |
|
|
42,939 |
|
|
|
(50,570 |
) |
Income tax
benefit |
|
|
981 |
|
|
— |
|
|
|
727 |
|
|
|
— |
|
Net income
(loss) |
|
$ |
17,144 |
|
$ |
(36,288 |
) |
|
$ |
43,666 |
|
|
$ |
(50,570 |
) |
|
|
|
|
|
|
|
|
|
TRANSLATE
BIO, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(IN
THOUSANDS) |
(UNAUDITED) |
|
|
|
|
|
June
30, |
|
December
31, |
|
|
|
|
|
|
2021 |
|
|
|
2020 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
249,471 |
|
|
$ |
342,027 |
|
|
|
Investments |
|
417,727 |
|
|
|
312,001 |
|
|
|
Collaboration receivables |
|
24,030 |
|
|
|
26,598 |
|
|
|
Prepaid expenses and other current assets |
|
20,958 |
|
|
|
11,741 |
|
|
|
Restricted cash |
|
4,826 |
|
|
|
4,826 |
|
|
|
|
|
Total
current assets |
|
717,012 |
|
|
|
697,193 |
|
Property and equipment, net |
|
18,249 |
|
|
|
15,372 |
|
Right-of-use assets, net |
|
68,123 |
|
|
|
72,957 |
|
Goodwill |
|
21,359 |
|
|
|
21,359 |
|
Intangible assets, net |
|
74,507 |
|
|
|
79,127 |
|
Other assets |
|
5,620 |
|
|
|
3,928 |
|
|
|
|
|
Total
assets |
$ |
904,870 |
|
|
$ |
889,936 |
|
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity |
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
13,736 |
|
|
$ |
8,839 |
|
|
|
Accrued expenses |
|
15,079 |
|
|
|
13,202 |
|
|
|
Current portion of deferred revenue |
|
41,014 |
|
|
|
67,563 |
|
|
|
Current portion of operating lease liability |
|
11,685 |
|
|
|
11,733 |
|
|
|
|
|
Total
current liabilities |
|
81,514 |
|
|
|
101,337 |
|
Contingent consideration |
|
112,493 |
|
|
|
152,230 |
|
Deferred revenue, net of current portion |
|
252,055 |
|
|
|
228,659 |
|
Operating lease liability, net of current portion |
|
46,171 |
|
|
|
50,953 |
|
|
|
|
|
Total
liabilities |
|
492,233 |
|
|
|
533,179 |
|
|
|
|
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Common stock |
|
75 |
|
|
|
75 |
|
|
|
Additional paid-in capital |
|
782,144 |
|
|
|
769,965 |
|
|
|
Accumulated deficit |
|
(369,617 |
) |
|
|
(413,283 |
) |
|
|
Accumulated other comprehensive income |
|
35 |
|
|
|
— |
|
|
|
|
|
Total
stockholders' equity |
|
412,637 |
|
|
|
356,757 |
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
904,870 |
|
|
$ |
889,936 |
|
|
|
|
|
|
|
|
|
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