Translate Bio Announces Second Quarter 2021 Financial Results and Provides Corporate Update
-- Entered into a definitive agreement under which Sanofi will acquire, subject to customary conditions to closing, all outstanding shares of
-- Advanced mRNA infectious disease vaccine programs, including
-- Continued progress in development of mRNA therapeutics for pulmonary diseases including preclinical next-generation cystic fibrosis (CF) and primary ciliary dyskinesia (PCD) programs --
“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
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 Pasteurrelated to its influenza mRNA vaccine program. Translate Bioreceived a $50 millionpayment from Sanofi Pasteurfor 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
Collaboration revenue was
Operating expenses for the three months ended
- Research and development expenses of
$40.5 millionduring the second quarter of 2021, compared to $29.0 millionfor 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 millionduring the second quarter of 2021, compared to $8.6 millionfor the same period in 2020. The increase is primarily due to increases in personnel-related costs and professional fees.
- Operating expenses of
$4.2 millionfor change in the fair value of contingent consideration related to future potential milestone and earnout payment obligations. The operating expense was primarily attributed to an increase in the fair value of the contingent consideration liability due to the time value of money due to the passage of time and a decrease in the discount rate.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: Translate Bio’s expectations with respect to its collaboration with
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended
||Six Months Ended
|Research and development||40,477||29,002||81,617||50,442|
|General and administrative||11,921||8,601||22,738||16,060|
|Change in fair value of contingent consideration||4,242||15,347||(39,737||)||5,895|
|Total operating expenses||56,640||52,950||64,618||72,397|
|Income (loss) from operations||16,009||(36,631||)||42,631||(51,423||)|
|Other income, net||154||343||308||853|
|Income (loss) before income taxes||16,163||(36,288||)||42,939||(50,570||)|
|Income tax benefit||981||—||727||—|
|Net income (loss)||$||17,144||$||(36,288||)||$||43,666||$||(50,570||)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||249,471||$||342,027|
|Prepaid expenses and other current assets||20,958||11,741|
|Total current assets||717,012||697,193|
|Property and equipment, net||18,249||15,372|
|Right-of-use assets, net||68,123||72,957|
|Intangible assets, net||74,507||79,127|
|Liabilities and Stockholders' Equity|
|Current portion of deferred revenue||41,014||67,563|
|Current portion of operating lease liability||11,685||11,733|
|Total current liabilities||81,514||101,337|
|Deferred revenue, net of current portion||252,055||228,659|
|Operating lease liability, net of current portion||46,171||50,953|
|Additional paid-in capital||782,144||769,965|
|Accumulated other comprehensive income||35||—|
|Total stockholders' equity||412,637||356,757|
|Total liabilities and stockholders' equity||$||904,870||$||889,936|
Source: Translate Bio, Inc.