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Translate Bio, Inc. (TBIO)

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22.26-0.27 (-1.20%)
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22.00 -0.26 (-1.17%)
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Previous Close22.53
Open22.52
Bid22.24 x 1400
Ask23.50 x 800
Day's Range22.14 - 23.27
52 Week Range6.80 - 34.64
Volume815,439
Avg. Volume1,301,541
Market Cap1.654B
Beta (5Y Monthly)0.87
PE Ratio (TTM)N/A
EPS (TTM)-1.01
Earnings DateNov 05, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est32.25
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  • Translate Bio Announces Fourth Quarter and Full Year 2020 Financial Results and Highlights Recent Progress
    GlobeNewswire

    Translate Bio Announces Fourth Quarter and Full Year 2020 Financial Results and Highlights Recent Progress

    -- Additional interim data expected in early Q2 from Phase 1/2 clinical trial of MRT5005 for the treatment of cystic fibrosis (CF) -- -- Two infectious disease mRNA vaccine programs expected to enter clinic in 2021: COVID-19 in Q1 and influenza in mid-2021, in collaboration with partner Sanofi Pasteur -- -- Established TBIO 2025 long-term strategic plan to leverage established mRNA platform and measured growth to capture mRNA opportunities in multiple therapeutic areas -- LEXINGTON, Mass., Feb. 25, 2021 (GLOBE NEWSWIRE) -- 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 and business highlights for the fourth quarter and full year ended December 31, 2020. “2020 ushered in a new era of mRNA possibilities—for vaccines and therapeutics—in which the promise of mRNA medicines became a reality,” said Ronald Renaud, chief executive officer of Translate Bio. “We are optimistic and remain focused on our mission of developing mRNA medicines to treat or prevent diseases and we look forward to several anticipated milestones in 2021, including the next interim analysis from our clinical trial in patients with CF early in the second quarter, and the planned initiation of two clinical programs by our partner, Sanofi Pasteur: a COVID-19 vaccine candidate in the first quarter and an influenza vaccine candidate in mid-2021.” Renaud continued, “With a deep mRNA scientific foundation, a strong cash position and positive momentum across our pipeline, we believe we are well-positioned to capture the significant potential of mRNA. We have established TBIO 2025, a strategic plan that emphasizes several areas for value creation with a focus on advancing multiple investigational new drug applications (INDs), new pipeline programs and platform innovation over the next five years. This plan will be aimed at enhancing speed, flexibility and control across our research engine so that we continue to be at the forefront of the discovery and development of transformative mRNA medicines.” 2020 and Recent Accomplishments MRT5005 for the Treatment of CF, Phase 1/2 Clinical Trial: Completed dosing in cohorts for the second interim data analysis, which is expected to be reported in early Q2 2021. These include multiple-ascending dose (MAD) groups (8, 12 and 16 mg), and a single-ascending dose (SAD) group (20 mg).Other Pulmonary Programs: Advanced next-generation CF and primary ciliary dyskinesia (PCD) programs with positive preclinical data generated to support planned initiation of IND-enabling studies in the second half of 2021.Infectious Disease Vaccine Programs: Executed two expansions of the collaboration with Sanofi Pasteur, for COVID-19 in March 2020 and for all infectious disease vaccines in June 2020. Advanced preclinical COVID-19 and influenza vaccine programs to enable expected initiation of clinical trials in 2021.Long-term Strategic Planning: Established TBIO 2025, a strategic plan focused on several areas of value creation and measured growth - adding key in-house capabilities, deepening pulmonary and delivery expertise, increasing research and development (R&D) investments as well as supporting infrastructure with a continued goal of advancing platform innovation and driving multiple programs into the clinic. This long-term plan incorporates an R&D strategy with a continued focus on mRNA therapeutics for pulmonary indications, an expanded effort in mRNA therapeutics for liver diseases and an exploration of new areas for application of the technology including therapeutic antibodies and protein degradation. It also includes the continued comprehensive effort to develop mRNA vaccines for infectious diseases with Sanofi Pasteur. Anticipated 2021 Milestones COVID-19 Vaccine (MRT5500): Initiate Phase 1/2 clinical trial in Q1 2021 (Sanofi Pasteur collaboration)Flu Vaccine: Advance lead lipid nanoparticle (LNP)/mRNA formulations to clinical proof of technology trial anticipated to begin mid-year 2021 (Sanofi Pasteur collaboration)CF Clinical Program (MRT5005): Report interim results from 20 mg SAD dose group and 8, 12, 16 mg MAD dose groups of the ongoing Phase 1/2 clinical trial in early Q2 2021Report interim results from 20 mg MAD dose group and daily dosing cohort CF Discovery Program (Next-generation CF): Advance lead candidate into IND-enabling studies in 2H 2021PCD: Advance lead candidate into IND-enabling studies in 2H 2021Pulmonary Arterial Hypertension: Conduct preclinical studies to validate targetsLiver: Apply next-generation liver delivery LNPs to identify liver diseases for further evaluationmRNA Platform: Identify next-generation LNPs to support liver, lung and additional disease program development, and explore new areas for application of mRNA technology including therapeutic antibodies and protein degradation Upcoming Events The Company plans to participate in the following virtual investor conference: SVB Leerink Virtual 10th Annual Global Healthcare Conference: Ronald Renaud, chief executive officer, will participate in a fireside chat on Friday, February 26, 2021 at 9:20 a.m. EST. Fourth Quarter and Full Year 2020 Financial Results and Financial Guidance Translate Bio ended the fourth quarter of 2020 with $654.0 million in cash, cash equivalents and investments and 75,029,625 shares of common stock outstanding. The Company expects that its existing cash, cash equivalents and investments will enable it to fund its operating expenses and capital expenditure requirements through 2023. Translate Bio reported a net loss of $20.6 million and $31.0 million for the three months ended December 31, 2020 and 2019, respectively, and a net loss of $53.8 million and $113.3 million for the years ended December 31, 2020 and 2019, respectively. Collaboration revenue was $51.4 million and $3.9 million for the three months ended December 31, 2020 and 2019, respectively, and $138.8 million and $7.8 million for the years ended December 31, 2020 and 2019, respectively. The increase in collaboration revenue, all of which is derived from the collaboration with Sanofi, related to increased activities for the vaccine program as well as a cumulative catch-up of revenue resulting from increases in the transaction price during the twelve months ended December 31, 2020. Operating expenses for the three months ended December 31, 2020 were $72.0 million, compared to $35.6 million for the same period in 2019, and were comprised of the following: Research and development expenses of $32.8 million during the fourth quarter of 2020, compared to $25.0 million for the same period in 2019. The increase is primarily due to continued development of the Company’s vaccine program associated with the Sanofi collaboration and discovery program as well as an increase in occupancy costs and personnel-related costs, partially offset by a decrease in expenses related to the Company’s MRT5005 program.General and administrative expenses of $10.7 million during the fourth quarter of 2020, compared to $7.3 million for the same period in 2019. The increase is primarily due to increases in personnel-related costs and professional fees.Change in the fair value of contingent consideration of $28.5 million during the fourth quarter of 2020, compared to $3.3 million for the same period in 2019, related to future potential milestone and earnout payment obligations. The operating expense recognized during the fourth quarter of 2020 was attributed to an increase in the fair value of the contingent consideration liability due to the time value of money due to passage of time and a decrease in the discount rate. Operating expenses for the year ended December 31, 2020 were $194.1 million, compared to $123.6 million for the same period in 2019, and were comprised of the following: Research and development expenses of $109.6 million during the year ended December 31, 2020, compared to $76.4 million for the same period in 2019. The increase is primarily due to continued development of the Company’s vaccine program associated with the Sanofi collaboration and discovery program as well as an increase in personnel-related costs, partially offset by a decrease in expenses related to the Company’s MRT5005 and MRT5201 programs.General and administrative expenses of $35.9 million during the year ended December 31, 2020, compared to $28.6 million for the same period in 2019. The increase is due to an increase in personnel-related costs and professional fees.Change in the fair value of contingent consideration of $48.6 million during the year ended December 31, 2020, compared to less than $0.1 million for the same period in 2019, related to future potential milestone and earnout payment obligations. The operating expense recognized during the year ended December 31, 2020 was attributed to an increase in the fair value of the contingent consideration liability due to the time value of money due to 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. 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 plans to report interim data from its Phase 1/2 clinical trial for MRT5005 in CF in the second quarter of 2021; the plans to commence clinical trials for a COVID-19 vaccine in the first quarter of 2021 and for a flu vaccine mid-year 2021; the advancement of lead candidates for next-generation CF and PCD programs in the second half of 2021; the goals and objectives of the TBIO 2025 long-term strategic plan; the potential for mRNA-based therapeutics to apply to the treatment of many diseases caused by protein or gene dysfunction; Translate Bio’s beliefs regarding the broad applicability of its technology; Translate Bio’s plans to advance its pipeline of mRNA therapeutics and validate targets for additional pulmonary diseases; Translate Bio’s plans to advance its additional disease programs; and the period in which Translate Bio expects that its existing cash, cash equivalents and investments will enable it to fund its operating expenses and capital expenditure requirements. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forward,” “intend,” “may,” “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: the current and potential future impacts of the COVID-19 pandemic on Translate Bio’s business, financial condition, operations and liquidity; Translate Bio’s ability to advance the development of its platform and programs, including without limitation, 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; uncertainties relating to the discovery and development of vaccine candidates based on mRNA; the content and timing of decisions made by the U.S. Food and Drug Administration, 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 and other important risk factors set forth under the caption “Risk Factors” in Translate Bio’s Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2020 filed with the Securities and Exchange Commission on November 5, 2020 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. TRANSLATE BIO, INC.CONSOLIDATED STATEMENTS OF OPERATIONS(IN THOUSANDS) Three Months Ended December 31, Years Ended December 31, 2020 2019 2020 2019 Collaboration revenue $51,392 $3,890 $138,811 $7,804 Operating expenses: Research and development 32,845 25,025 109,629 76,369 General and administrative 10,699 7,348 35,922 28,632 Change in fair value of contingent consideration 28,490 3,256 48,575 13 Impairment of intangible asset — — — 18,559 Total operating expenses 72,034 35,629 194,126 123,573 Loss from operations (20,642) (31,739) (55,315) (115,769)Other income, net 81 703 1,528 1,990 Loss before benefit from income taxes (20,561) (31,036) (53,787) (113,779)Benefit from income taxes — — — 486 Net loss $(20,561) $(31,036) $(53,787) $(113,293) TRANSLATE BIO, INC.CONSOLIDATED BALANCE SHEETS(IN THOUSANDS) December 31, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents$342,027 $84,580 Investments 312,001 104,098 Collaboration receivables 26,598 4,596 Prepaid expenses and other current assets 11,741 9,391 Restricted cash 4,826 950 Total current assets 697,193 203,615 Property and equipment, net 15,372 12,539 Right-of-use assets, net 72,957 10,400 Goodwill 21,359 21,359 Intangible assets, net 79,127 85,536 Other assets 3,928 2,752 Total assets$889,936 $336,201 Liabilities and Stockholders' Equity Current liabilities: Accounts payable$8,839 $15,968 Accrued expenses 13,202 7,072 Current portion of deferred revenue 67,563 18,100 Current portion of operating lease liability 11,733 530 Total current liabilities 101,337 41,670 Contingent consideration 152,230 103,655 Deferred revenue, net of current portion 228,659 25,256 Operating lease liability, net of current portion 50,953 12,084 Total liabilities 533,179 182,665 Stockholders’ equity: Common stock 75 60 Additional paid-in capital 769,965 512,231 Accumulated deficit (413,283) (359,496) Accumulated other comprehensive income — 741 Total stockholders' equity 356,757 153,536 Total liabilities and stockholders' equity$889,936 $336,201 Contacts for Translate Bio Investors Media Teri Dahlman Maura Gavaghan tdahlman@translate.bio mgavaghan@translate.bio 617-817-8655 617-233-1154

  • Translate Bio to Present at the SVB Leerink Virtual 10th Annual Global Healthcare Conference
    GlobeNewswire

    Translate Bio to Present at the SVB Leerink Virtual 10th Annual Global Healthcare Conference

    LEXINGTON, Mass., Feb. 18, 2021 (GLOBE NEWSWIRE) -- 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 that Ronald Renaud, chief executive officer, will participate in a fireside chat at the SVB Leerink Virtual 10th Annual Global Healthcare Conference on Friday, February 26, 2021 at 9:20 a.m. EST. A live webcast of the session will be accessible through the “Events and Presentations” page of the Company's website at investors.translate.bio. A replay of the webcasts will be archived on the Translate Bio’s website for 30 days following the presentation. 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. Contacts for Translate Bio InvestorsTeri Dahlmantdahlman@translate.bio617-817-8655MediaMaura Gavaghanmgavaghan@translate.bio 617-233-1154

  • Sanofi’s COVID-19 Vaccine With Translate Bio Delayed Until Next Year – Report
    SmarterAnalyst

    Sanofi’s COVID-19 Vaccine With Translate Bio Delayed Until Next Year – Report

    Sanofi’s CEO, Paul Hudson, said that the mRNA-based (messenger Ribonucleic acid) COVID-19 vaccine developed by the pharma giant and Translate Bio will not be ready this year, according to a Reuters report, citing the French newspaper Le Journal du Dimanche. Sanofi (SNYNF) expects to start the clinical trials of the mRNA-based vaccine this quarter, Reuters said, citing Le Journal du Dimanche. Hudson told the French newspaper, “This vaccine will not be ready this year, but it could be of use at a later stage all the more if the fight against variants was to continue.” In October last year, the company had said that the pre-clinical trials of the experimental COVID-19 vaccine developed along with Translate Bio (TBIO) resulted in the production of neutralizing antibodies, indicating a favorable response from the immune system. At that time, the company said that it expected to begin a Phase 1 clinical trial in the last quarter of 2020. The delay in the development of the vaccine could be another setback for Sanofi, in addition to the delay in the development of its COVID-19 vaccine along with Glaxo SmithKline (GSK). In December last year, Sanofi had said that a Phase 1 study of the antigen-based COVID-19 vaccine indicated that it was less effective in older adults as compared to adults in the age group of 18 to 49 years. This prompted Sanofi to say that it plans to conduct a Phase 2b study in February this year with an improved antigen formulation of the vaccine, and expects to bring the vaccine to market in the fourth quarter of this year. Sanofi has also collaborated with other companies to develop or manufacture a COVID-19 vaccine. Late last month, Sanofi announced an agreement with BioNTech (BNTX), under which the company will provide BioNTech access to its production infrastructure for the COVID-19 vaccine. BioNTech is developing its COVID-19 vaccine along with Pfizer (PFE). From the summer of this year, Sanofi will conduct late-stage manufacturing of the BioNTech vaccine and aims to supply 125 million doses to the European Union (EU) to increase the availability of the vaccine. (See Sanofi stock analysis on TipRanks) Earlier this month, following the company’s 4Q and FY20 results, Liberum Capital analyst Alistair Campbell reiterated a Hold rating and a price target of $116.36 on the stock. Campbell said that the company’s 4Q and FY20 results were a “solid end” to the year, and while the analyst notes that the company’s outlook was slightly below consensus estimates, it appeared to be on the conservative side. Meanwhile, Sanofi scores a Moderate Buy consensus rating from the analyst community. That’s based on 9 analysts recommending a Buy, 4 analysts suggesting a Hold and 1 analyst recommending a Sell. The average analyst price target of $117.23 implies 24.9% upside potential to current levels. Related News: J&J Files For FDA Approval Of COVID-19 Vaccine; Street is Bullish Bio-Rad 4Q Sales Top Estimates Driven By COVID-19 Demand Microsoft Showed Interest In Pinterest Takeover – Report More recent articles from Smarter Analyst: Becton Dickinson Gets EUA For New Diagnostic Test G1 Therapeutics Wins FDA Approval For COSELA Drug; Shares Pop 20% Amtech Earnings Beat Estimates; Shares Pop 22% Illumina Reports Better-Than-Expected Q4 Earnings; Shares Slip Pre-Market