FIS adds premium Dow Jones content to MarketMap Terminal

NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) — Dow Jones content is now available through FIS’s MarketMap Terminal, under an expanded partnership that will give financial professionals access to premium news, data and analysis from Dow Jones’s trusted brands.

From today, MarketMap users will have access to daily content from Dow Jones Newswires, The Wall Street Journal, Barron’s, MarketWatch and WSJ Pro. This news and analysis is supplemented by Dow Jones Calendar Live data feed, which covers press conferences, scheduled announcements and data releases from more than 1,000 economic events and 11,500 companies.

MarketMap users will also benefit from the addition of NewsPlus, Dow Jones’s customizable, real-time news dashboard. Available in 12 languages, NewsPlus displays both real-time streaming news together with content curated by Dow Jones’s global newsroom to provide an instant snapshot of markets throughout the trading day.

“We pride ourselves on offering the real-time news and information our clients need,” said Nasser Khodri, EVP, Sell-side, Capital Markets, FIS. “Integrating Dow Jones premium content offers even more value to our users, helping them keep up with news, data and insights from the brands they trust — without ever leaving the MarketMap terminal.”

“As a long-time partner with FIS, we are excited to expand access to our premium content and data to all MarketMap users,” said Joanna Appleton, Head of Partnerships and Licensing EMEA at Dow Jones. “This agreement significantly extends the reach of Dow Jones’s trusted journalism and data to the global financial community, helping them to uncover market opportunities and inform their investment decisions.”

More information about FIS MarketMap is available here.

About Dow Jones

Dow Jones is a global provider of news and business information, delivering content to consumers and organizations around the world across multiple formats, including print, digital, mobile and live events. Dow Jones has produced unrivaled quality content for more than 130 years and today has one of the world’s largest news gathering operations globally. It produces leading publications and products including the flagship Wall Street Journal, America’s largest newspaper by paid circulation; Factiva, Barron’s, MarketWatch, Financial News, Dow Jones Risk & Compliance, and Dow Jones Newswires. Dow Jones is a division of News Corp (Nasdaq: NWS, NWSA; ASX: NWS, NWSLV).

About FIS

FIS is a leading provider of technology solutions for merchants, banks and capital markets firms globally. Our employees are dedicated to advancing the way the world pays, banks and invests by applying our scale, deep expertise and data-driven insights. We help our clients use technology in innovative ways to solve business-critical challenges and deliver superior experiences for their customers. Headquartered in Jacksonville, Florida, FIS is a Fortune 500® company and is a member of Standard & Poor’s 500® Index. To learn more, visit www.fisglobal.com. Follow FIS on Facebook, LinkedIn and Twitter (@FISGlobal).

Media Contact

Louise Mead
[email protected]



Silence Therapeutics Presents Positive Pre-Clinical Data for SLN360 for the Treatment of Elevated Lipoprotein(a) at American Heart Association 2020

Silence Therapeutics Presents Positive Pre-Clinical Data for SLN360 for the Treatment of Elevated Lipoprotein(a) at American Heart Association 2020


  • Pre-clinical safety data show no adverse or off-target effects and targeted biodistribution of the company’s wholly owned gene-silencing candidate SLN360

  • Profile supports SLN360’s progression to in-human testing for the treatment of elevated lipoprotein(a), an independent risk factor for premature heart disease, heart attack and stroke

16 November 2020

LONDON, Silence Therapeutics plc, AIM:SLN and Nasdaq: SLN (“Silence” or “the Company”), a leader in the discovery, development and delivery of novel short interfering ribonucleic acid (siRNA) therapeutics for the treatment of diseases with significant unmet medical need, has presented positive pre-clinical safety data for its wholly owned lead product candidate, SLN360, at the American Heart Association (AHA)’s virtual Scientific Sessions 2020, being held 14-16 November.1 The results, available here, demonstrated that the potent and sustained reduction of lipoprotein(a) – Lp(a) – levels in in vitro and animal models treated with SLN360 was not associated with any adverse or off-target effects.1

Giles Campion, Head of R&D and Chief Medical Officer of Silence Therapeutics commented:The strength of our pre-clinical safety data, coupled with the efficacy data presented at the AHA congress this time last year, demonstrates the precision with which we are able to target the appropriate gene and deliver robust knockdown of Lp(a) levels with long duration of action. Safety is always important but particularly when a therapy has the potential to be administered to a large population as a long-term preventative measure. These results give us confidence to move SLN360 into the clinic, to develop a transformational medicine for the millions of people facing a higher risk of cardiovascular disease due to elevated Lp(a).

Recent evidence has shown that elevated Lp(a) serum levels is a key independent, genetic and causal risk factor for premature heart disease, heart attack and stroke.2 It is estimated to affect 20% of individuals worldwide, with limited treatment strategies currently available. By directly targeting and silencing the LPA gene within the liver, SLN360 is designed to lower levels of Lp(a), which in turn is expected to lower the risk of premature cardiovascular disease.

Results presented today show that the distribution of SLN360 is confined to the liver (target organ) and kidney (route of elimination) as intended, with levels of SLN360 in other organs (including reproductive organs) less than 1% of peak liver levels. Its restricted biodistribution and the absence of off-target effects supports the progression of SLN360 to in-human testing. 

The Phase I APOLLO trial is now recruiting (NCT04606602), to investigate the safety, tolerability, pharmacokinetic and pharmacodynamic response of SLN360 in people with elevated Lp(a). If successful in clinical trials, SLN360 may provide a novel therapeutic approach to address Lp(a)-related cardiovascular disorders. More information on the trial can be found here.

References

  1. Rider D, et al. Pre-clinical Safety Assessment of SLN360, A Novel Short Interfering Ribonucleic Acid Targeting LPA, presented at the American Heart Association (AHA) Scientific Sessions, November 2020.
  2. Tsimikas S, A Test in Context: Lipoprotein(a): Diagnosis, Prognosis, Controversies, and Emerging Therapies, J Am Coll Cardiol. 2017;69(6):692-711.

Enquiries:

Silence Therapeutics plc

Gem Hopkins, Head of IR and Corporate Communications
[email protected]

 

Tel:  +1 (646) 637-3208
 
Investec Bank plc
(Nominated Adviser and Broker)

Daniel Adams/Gary Clarence

 

  Tel:  +44 (0) 20 7597 5970
European IR

Consilium Strategic Communications

Mary-Jane Elliott/Chris Welsh/Angela Gray
[email protected]

 

Tel: +44 (0) 20 3709 5700
U.S. IR

Westwicke Partners

Peter Vozzo
[email protected]

 

 Tel: +1 (443) 213-0505

About SLN360

Silence’s wholly owned lead product candidate, SLN360, is a gene ‘silencing’ therapy – one that is designed to temporarily block a specific gene’s message that would otherwise trigger an unwanted effect. In this case, it aims to ‘silence’ LPA, a gene that tells the body to make a specific protein that is only found in Lp(a). By silencing LPA, the levels of Lp(a) are lowered, which in turn is expected to lower the risk of heart diseases, heart attacks and strokes. Silence is evaluating SLN360 in its APOLLO Phase 1 dose escalation study designed to assess the safety, tolerability, pharmacokinetic and pharmacodynamic response of SLN360 in people with elevated Lp(a). More information on the trial can be found here.

About Lipoprotein(a)

Lipoprotein(a), known as Lp(a) for short, is a particle made by the liver, which consists of cholesterol, fats and proteins. Most people have some Lp(a) in their body, but about 1 in 5 people have high levels of Lp(a), because of a specific gene variation in their DNA. Most people are unaware if they have elevated Lp(a). People living with elevated Lp(a) have a higher risk of developing early heart disease, heart attacks and strokes. Most standard cholesterol tests do not currently include screening for Lp(a). Current medicines that are used to lower other lipid levels in the blood do not have a meaningful effect on Lp(a) and are less effective overall in people with high levels of Lp(a).

About Silence Therapeutics

Silence Therapeutics is developing a new generation of medicines by harnessing the body’s natural mechanism of RNA interference, or RNAi, to inhibit the expression of specific target genes thought to play a role in the pathology of diseases with significant unmet medical need. Silence’s proprietary technology can be used to engineer short interfering ribonucleic acids (siRNAs) that bind specifically to and silence, through the RNAi pathway, almost any gene in the human genome to which siRNA can be delivered. Silence’s wholly owned product candidates include SLN360 designed to address the high and prevalent unmet medical need in reducing cardiovascular risk in people born with high levels of Lipoprotein(a) and SLN124 to address beta-thalassemia and myelodysplastic syndrome. Silence is also developing SLN500, a C3 targeting programme, in partnership with Mallinckrodt Pharmaceuticals to reduce the expression of the C3 protein for the treatment of complement pathway-mediated diseases.  Silence maintains ongoing research and collaborations with AstraZeneca, Mallinckrodt Pharmaceuticals and Takeda. For more information, please visit: https://www.silence-therapeutics.com/

Forward-Looking Statements

Certain statements made in this announcement are forward-looking statements, including with respect to the Company’s clinical and commercial prospects. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions.  Words such as ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company’s control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.



ProQR Announces Third Quarter 2020 Operating and Financial Results

  • Illuminate Phase 2/3 trial of sepofarsen expected to complete enrollment in Q1 2021; additional data from Phase 1/2 InSight extension study to be reported in H2 2021
  • Enrollment completed for QR-421a dosing cohorts and data from next Phase 1/2 interim analysis expected in H1 2021
  • Initial data from Phase 1/2 trial of QR-1123 expected in 2021
  • QR-504a clinical study in Fuchs expected to start in H1 2021
  • Cash runway into 2023

LEIDEN, Netherlands & CAMBRIDGE, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — ProQR Therapeutics N.V. (Nasdaq: PRQR) (the “Company”), a company dedicated to changing lives through the creation of transformative RNA therapies for inherited retinal diseases (IRDs), today reported its financial and operating results for the third quarter ended September 30, 2020 and provided a business update, including updated timeline guidance for the Company’s clinical stage programs.

“We’re pleased to report that our clinical trials are back on track after the COVID-19 disruption, with all ongoing trials either already completed or expected to complete enrollment in the near term. With this progress we are well positioned heading into 2021 and beyond to make meaningful advancements across our portfolio,” said Daniel A. de Boer, Chief Executive Officer of ProQR. “We will enter 2021 with the Illuminate trial of sepofarsen expected to complete enrollment in the first quarter and we anticipate reporting data across our clinical pipeline during the year ahead, which represents the opportunity for multiple potential value inflection points. This will include the next interim analysis for QR-421a and initial data for QR-1123. We also plan to share updated data from the Phase 1/2 extension study of sepofarsen and to start dosing patients with QR-504a.”

De Boer continued, “As we continue to build a robust IRD translational platform, we are pleased to have appointed Naveed Shams, MD, PhD, as our Chief Scientific Officer. Naveed is a proven leader with deep ophthalmology experience, including multiple product approvals globally. This expertise further strengthens our focus as an ophthalmology company and supports our commitment to bringing therapies to patients with inherited retinal diseases.”


Business Operations and Program Updates

Sepofarsen, lead clinical candidate for Leber congenital amaurosis 10 (LCA10) in the Phase 2/3 Illuminate trial:

  • In July, the Company presented positive data from the ongoing InSight extension study of sepofarsen for LCA10, in which patients from the completed Phase 1/2 study were offered treatment in their second eye. These data showed that in 4 out of 4 second eyes treated, the treatment response was consistent with the first eye treated including a significant and sustained benefit, building further confidence in the Phase 2/3 Illuminate trial.
    • In October and November, the following data was presented at Euretina and the American Academy of Ophthalmology (AAO) virtual annual meetings, and both presentations were selected as “Best Poster” at AAO:
      • Phase 1b/2 trial results of the intravitreal sepofarsen RNA therapy in LCA10 (encore presentations)
      • Full-field stimulus testing (FST) to assess sepofarsen patient response in LCA10
  • The Company has activated sites in North America, Europe, and South America to enable rapid completion of the Illuminate trial enrollment. All of the remaining patients to be enrolled in the trial have been pre-screened and identified.
  • Upcoming sepofarsen anticipated events:
    • The Company expects to complete enrollment in the Phase 2/3 pivotal Illuminate trial in Q1 2021, assuming sites are able to continue operations with respect to the COVID-19 public health emergency. The primary endpoint for Illuminate is mean change from baseline in BCVA at 12 months.
    • Start a pediatric trial of sepofarsen in patients under 8 years of age in 2021. The primary objectives of this study are safety and tolerability,
    • Report updated data from the next interim analysis of the Phase 1/2 InSight extension study in H2 2021.

QR-421a for Usher syndrome and non-syndromic retinitis pigmentosa (nsRP):

  • Enrollment of the Phase 1/2 Stellar trial dose expansion (100 µg homozygous) and dose escalation (200 µg) cohorts is complete.
  • The Company anticipates reporting data from the next planned interim analysis of the Phase 1/2 Stellar trial in H1 2021.

QR-1123 for autosomal dominant retinitis pigmentosa (adRP):

  • The Phase 1/2 Aurora trial is ongoing with 4 of the 5 planned single dose cohorts having completed enrollment.
  • ProQR anticipates reporting initial data from the single dose cohorts of this program in 2021.

QR-504a for Fuchs Endothelial Corneal Dystrophy (FECD):

  • All preparations for the start of a Proof of Mechanism trial of QR-504a in patients with FECD are completed and, pending the lifting of COVID-19 restrictions, the Company plans to start enrolling patients with FECD type 3 in H1 of 2021.
  • Report initial data in H1 2022.

Business updates:

  • In July, to support funding of the Company’s pipeline, ProQR entered into a strategic convertible debt financing agreement with Pontifax Ventures where the Company will have access to up to $30 million in three tranches of $10 million with the first tranche drawn by the Company at closing. Subsequent to the closing with Pontifax, in August the loan facility was expanded by an additional €15 million (in three tranches of €5 million) with Kreos Capital, with €5 million drawn by the Company at closing. If fully drawn down, the capital from these facilities extends ProQR’s runway into 2023.
  • In October, Naveed Shams, MD, PhD, was appointed Chief Scientific Officer (CSO). As CSO, Dr. Shams provides strategic direction, oversight, and execution for ProQR’s research and early development efforts. He joined ProQR from Santen, a global company focused on ophthalmology, where he most recently served as Senior Corporate Officer, Head of Global Research and Development and Chief Scientific Officer.


Financial Highlights

At September 30, 2020, ProQR held cash and cash equivalents of €88.8 million, compared to €112.0 million at December 31, 2019. Net cash used in operating activities during the three-month period ended September 30, 2020 was €9.8 million, compared to €8.8 million for the same period last year.

Research and development costs were €8.3 million for the quarter ended September 30, 2020, compared to €11.1 million for the same period last year.

General and administrative costs were €2.8 million for the quarter ended September 30, 2020 compared to €2.9 million for the same period last year.

Net loss for the three-month period ended September 30, 2020 was €13.2 million or €0.26 per share, compared to a €12.2 million loss or €0.31 per share for the same period last year.

For further financial information for the period ended September 30, 2020, please refer to the financial statements appearing at the end of this release.


About Leber Congenital Amaurosis 10 (LCA10)

Leber congenital amaurosis (LCA) is the most common cause of blindness due to genetic disease in children. It consists of a group of diseases of which LCA10 is the most frequent and one of the most severe forms. LCA10 is caused by mutations in the CEP290 gene, of which the p.Cys998X mutation has the highest prevalence. LCA10 leads to early loss of vision causing most people to lose their sight in the first few years of life. To date, there are no treatments approved that treat the underlying cause of the disease. Approximately 2,000 people in the Western world have LCA10 because of this mutation.


About Sepofarsen

Sepofarsen (QR-110) is being evaluated in the pivotal Phase 2/3 Illuminate trial and is a first-in-class investigational RNA therapy designed to address the underlying cause of Leber congenital amaurosis 10 due to the p.Cys998X mutation (also known as the c.2991+1655A>G mutation) in the CEP290 gene. The p.Cys998X mutation leads to aberrant splicing of the mRNA and non-functional CEP290 protein. Sepofarsen is designed to enable normal splicing, resulting in restoration of normal (wild type) CEP290 mRNA and subsequent production of functional CEP290 protein. Sepofarsen is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the United States and the European Union and received fast-track designation and rare pediatric disease designation from the FDA as well as access to the PRIME scheme by the EMA.


About Usher Syndrome Type 2 and Non-Syndromic Retinitis Pigmentosa

Usher syndrome is the leading cause of combined deafness and blindness. People with Usher syndrome type 2 are usually born with hearing loss and start to have progressive vision loss during adulthood. The vision loss can also occur without hearing loss in a disease called non-syndromic retinitis pigmentosa. Usher syndrome type 2 and non-syndromic retinitis pigmentosa can be caused by mutations in the USH2A gene. To date, there are no pharmaceutical treatments approved or in clinical development that treat the vision loss associated with mutations in USH2A.


About QR-421a

QR-421a is being evaluated in the Phase 1/2 Stellar trial and is a first-in-class investigational RNA therapy designed to address the underlying cause of vision loss in Usher syndrome type 2a and non-syndromic retinitis pigmentosa (RP) due to mutations in exon 13 of the USH2A gene. QR-421a is designed to restore functional usherin protein by using an exon skipping approach with the aim to stop or reverse vision loss in patients. QR-421a is intended to be administered through intravitreal injections in the eye and has been granted orphan drug designation in the US and the European Union and received fast-track and rare pediatric disease designations from the FDA.


About Autosomal Dominant Retinitis Pigmentosa (adRP)

Autosomal dominant retinitis pigmentosa, or adRP, is a severe and rare genetic disease that causes progressive problems in night vision during childhood, leading to visual field loss and frequently resulting in blindness in mid adulthood. In the United States, the most prevalent mutation associated with adRP is the P23H point mutation (also known as the c.68C>A mutation) in the rhodopsin (RHO) gene and affects approximately 2,500 people. This mutation causes misfolding of the rhodopsin protein that becomes toxic to the photoreceptor cells and at the same time diminishes the function of the wild type allele. Over time this results in cell death and progressive vision loss. There are currently no therapies approved or in clinical development for P23H adRP. A natural history study in patients with P23H adRP has been conducted.


About QR-1123

QR-1123 is being evaluated in the Phase 1/2 Aurora trial and is a first-in-class investigational RNA therapy designed to treat adRP due to the P23H mutation in the RHO gene. QR-1123 was discovered and developed by Ionis Pharmaceuticals using Ionis’ proprietary antisense technology. The therapy aims to inhibit the formation of the mutated toxic version of the rhodopsin protein by specifically binding the mutated RHO mRNA. Binding of QR-1123 causes allele specific knockdown of the mutant mRNA by a mechanism called RNase H mediated cleavage without affecting the normal RHO mRNA. QR-1123 is intended to be administered through intravitreal injections in the eye. QR-1123 was in-licensed from Ionis Pharmaceuticals in 2018. QR-1123 has been granted Orphan Drug designation in the United States and received Fast Track designation from the FDA.


About Fuchs Endothelial Corneal Dystrophy (FECD)

Fuchs endothelial corneal dystrophy (FECD) is a common inherited condition characterized by the dysfunction and degeneration of the corneal endothelium, a single cell layer of cells on the inside of the cornea. FECD is a common disorder; it is estimated that FECD affects more than 4% of individuals over the age of 40 in the U.S., and similar prevalence is noted for other global regions. There are different types of this disease and we focus on age-related FECD Type 3 (FECD3). Some patients with age-related FECD develop advanced disease with corneal edema and corneal clouding. These symptoms can lead to complete vision loss and the need for surgery such as a corneal transplant.


About QR-504a

We are developing QR-504a as an RNA therapy for the treatment of FECD3. We plan to advance the QR-504a program into a first-in-human clinical trial in late-stage disease patients in 2021. QR-504a is designed to target the intronic TNRs in the TCF4 RNA. The aim is to reduce aggregation and the formation of RNA foci in order to normalize the RNA splicing patterns, and prevent or halt corneal degeneration in patients with FECD3.


About ProQR

ProQR Therapeutics is dedicated to changing lives through the creation of transformative RNA therapies for the treatment of severe genetic rare diseases such as Leber congenital amaurosis 10, Usher syndrome and retinitis pigmentosa. Based on our unique proprietary RNA repair platform technologies we are growing our pipeline with patients and loved ones in mind.

*Since 2012*


FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “look forward to”, “may,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would” and similar expressions. Such forward-looking statements include, but are not limited to, statements regarding sepofarsen (QR-110) and the clinical development and the therapeutic potential thereof, statements regarding our pipeline of programs targeting inherited retinal dystrophies, statements regarding QR-421a, and the clinical development and the therapeutic potential thereof,  statements regarding QR-1123 and the clinical development and therapeutic potential thereof, our other programs and business operations, including timing of commencing clinical trials and enrollment of patients therein, the expected impact of the COVID-19 on our business operations, including our research and development plans and timelines and the supply chain for our clinical and development programs, our loan facility with Pontifax and our financial position and cash runway. Forward-looking statements are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Our actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, the risks, uncertainties and other factors in our filings made with the Securities and Exchange Commission, including certain sections of our annual report filed on Form 20-F. These risks and uncertainties include, among others, the cost, timing and results of preclinical studies and clinical trials and other development activities by us and our collaborative partners whose operations and activities may be slowed or halted by the COVID-19 pandemic; the likelihood of our clinical programs being executed on timelines provided and reliance on our contract research organizations and predictability of timely enrollment of subjects and patients to advance our clinical trials and maintain their own operations; our reliance on contract manufacturers to supply materials for research and development and the risk of supply interruption from a contract manufacturer; the potential for future data to alter initial and preliminary results of early-stage clinical trials; the unpredictability of the duration and results of the regulatory review of applications or clearances that are necessary to initiate and continue to advance and progress our clinical programs; the ability to secure, maintain and realize the intended benefits of collaborations with partners; the possible impairment of, inability to obtain, and costs to obtain intellectual property rights; possible safety or efficacy concerns that could emerge as new data are generated in research and development; our ability to maintain and service our loan facility with Pontifax; and general business, financial and accounting risks and litigation. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.


Cautionary Note on Future Updates

The statements contained in this press release reflect our current views with respect to future events, which may change significantly as the global consequences of the COVID-19 pandemic rapidly develop. Accordingly, we do not undertake and specifically disclaim any obligation to update any forward-looking statements.


ProQR Therapeutics N.V.

Investor Contact:

Sarah Kiely
ProQR Therapeutics N.V.
T: +1 617 599 6228
[email protected]
or
Hans Vitzthum
LifeSci Advisors
T: +1 617 535 7743
[email protected]

Media Contact:

Alison Chen
LifeSci Communications
T: +1 646 876 4932
[email protected]


 



PROQR THERAPEUTICS N.V.



Unaudited Condensed Consolidated Statement of Financial Position


 

         
         
       September 30,       December 31, 
    2020   2019
    € 1,000   € 1,000
Assets          
Current assets          
Cash and cash equivalents    88,847    111,950
Prepayments and other receivables    2,759    1,866
Social securities and other taxes    552    850
         
Total current assets    92,158    114,666
         
Property, plant and equipment    17,875    2,440
Investments in associates    159    429
         
Total assets    110,192    117,535
         
Equity and liabilities          
Equity         
Equity attributable to owners of the Company    68,626    94,329
Non-controlling interests    (534)    (496)
Total equity    68,092    93,833
         
Current liabilities          
Borrowings    949    343
Lease liabilities    1,308    508
Derivative financial instruments    1,092    —
Trade payables    291    445
Current income tax liability    —    64
Social securities and other taxes    155    108
Pension premiums    —    2
Deferred income    863    711
Other current liabilities    6,159    8,812
         
Total current liabilities    10,817    10,993
         
Borrowings    16,577    12,709
Lease liabilities    14,706    –
         
Total liabilities    42,100    23,702
         
Total equity and liabilities    110,192    117,535


 


 

PROQR THERAPEUTICS N.V.

Unaudited Condensed Consolidated Statement of Profit or Loss and OCI

(€ in thousands, except share and per share data)

                 
         
    Three month period   Nine month period
    ended September 30,    ended September 30, 
                 
       2020      2019      2020      2019
    € 1,000   € 1,000   € 1,000   € 1,000
Other income                 251                 530              9,188              1,509
                 
Research and development costs            (8,304)          (11,074)          (29,716)          (32,560)
General and administrative costs            (2,809)            (2,903)          (10,173)            (8,970)
                         
Total operating costs          (11,113)          (13,977)          (39,889)          (41,530)
                         
Operating result          (10,862)          (13,447)          (30,701)          (40,021)
Finance income and expense            (1,863)              1,375            (2,024)              1,339
Results related to financial liabilities measured at fair value through profit or loss               (305)                   —               (305)                   —
Results related to associates                 (84)               (119)               (270)                 579
                         
Result before corporate income taxes          (13,114)          (12,191)          (33,300)          (38,103)
Income taxes                 (75)                   —                 (86)                 (64)
                         
Result for the period          (13,189)          (12,191)          (33,386)          (38,167)
Other comprehensive income               (255)                 147               (134)                 121
                         
Total comprehensive income (attributable to owners of the Company)          (13,444)          (12,044)          (33,520)          (38,046)
                 
Result attributable to                    
Owners of the Company          (13,181)          (12,139)          (33,348)          (37,945)
Non-controlling interests                   (8)                 (52)                 (38)               (222)
           (13,189)          (12,191)          (33,386)          (38,167)
                         
Share information                        
Weighted average number of shares outstanding1     50,143,262     38,912,701     50,017,990     38,902,203
                 
Earnings per share attributable to the equity holders of the Company (expressed in Euro per share)                
Basic loss per share1              (0.26)              (0.31)              (0.67)              (0.98)
Diluted loss per share1    (0.26)    (0.31)    (0.67)    (0.98)
  1. For this period presented in these financial statements, the potential exercise of share options is not included in the diluted earnings per share calculation as the Company was loss-making in all periods. Due to the anti-dilutive nature of the outstanding options, basic and diluted earnings per share are equal in this period.


 


 



PROQR THERAPEUTICS N.V.



Unaudited Condensed


Consolidated


Statement of Changes in Equity


 

                                         
                                         
    Attributable to owners of the Company        
                                         
                Equity settled   Option                    
                Employee   premium on               Non-    
    Number of   Share   Share   Benefit   convertible   Translation   Accumulated       controlling   Total
    shares   Capital   Premium   Reserve   loan   Reserve   Deficit   Total   interests   Equity
   
  
  € 1,000   € 1,000   € 1,000   € 1,000   € 1,000   € 1,000   € 1,000   € 1,000   € 1,000
Balance at January 1, 2019    43,149,987    1,726    235,744    10,780    —    108    (155,443)    92,915    (230)    92,685
Result for the period    —    —    —    —    —    —    (37,945)    (37,945)    (222)    (38,167)
Other comprehensive income    —    —    —    —    —    121    —    121    —    121
Recognition of share-based payments    —    —    —    4,614    —    —    —    4,614    —    4,614
Issuance of ordinary shares    —    —    —    —    —    —    —    —    —    —
Treasury shares transferred    (40,259)    —    —    —    —    —    —    —    —    —
Share options lapsed    —    —    —    (33)    —    —    33    —    —    —
Share options exercised    40,259    —    166    (115)    —    —    115    166    —    166
                                         
Balance at September 30, 2019    43,149,987    1,726    235,910    15,246    —    229    (193,240)    59,871    (452)    59,419
                                         
Balance at January 1, 2020    53,975,838    2,159    287,214    16,551    —    151    (211,746)    94,329    (496)    93,833
Result for the period    —    —    —    —    —    —    (33,348)    (33,348)    (38)    (33,386)
Other comprehensive income    —    —    —    —    —    (134)    —    (134)    —    (134)
Recognition of share-based payments    —    2    283    6,218    —    —    —    6,503    —    6,503
Issuance of ordinary shares    100,902    2    270    —    —    —    —    272    —    272
Treasury shares transferred    (299,615)    —    —    —    —    —    —    —    —    —
Recognition of equity component of convertible loan    —    —    —    —    280    —    —    280    —    280
Share options lapsed    —    —    —    (63)    —    —    63    —    —    —
Share options exercised    299,615    —    724    (466)    —    —    466    724    —    724
                                                   
Balance at September 30, 2020    54,076,740    2,163    288,491    22,240    280    17    (244,565)    68,626    (534)    68,092


 


 



 



PROQR THERAPEUTICS N.V.



Unaudited Condensed


Consolidated


Statement of Cash Flows

                 
                 
    Three month period    Nine month period
    ended September 30,    ended September 30, 
                 
       2020      2019      2020      2019
    € 1,000   € 1,000   € 1,000   € 1,000
Cash flows from operating activities                    
Net result          (13,189)          (12,191)          (33,386)          (38,167)
Adjustments for:                
— Depreciation                 651                 506              1,703              1,543
— Share-based compensation              1,676              1,226              6,348              4,614
— Other income                   —                   —            (8,423)                   —
— Financial income and expenses              1,863            (1,375)              2,024            (1,339)
— Results related to associates                   84                 119                 270               (579)
— Results related to financial liabilities measured at fair value through
     profit or loss
                305                   —                 305                   —
— Net foreign exchange gain / (loss)               (255)                 148               (134)                 122
                 
Changes in working capital               (246)              2,718            (3,354)              1,744
Cash used in operations           (9,111)           (8,849)         (34,647)         (32,062)
                         
Corporate income tax paid               (157)                   —               (168)                 (64)
Interest received                   27                   90                 118                 176
Interest paid               (569)                 (13)               (607)                 (64)
                         

Net cash used in operating activities
 
        (9,810)
 
        (8,772)
 
      (35,304)
 
      (32,014)
                         
Cash flow from investing activities                        
Purchases of property, plant and equipment               (264)                 (32)               (806)               (341)
                         

Net cash used in investing activities
 
           (264)
 
             (32)
 
           (806)
 
           (341)
                         
Cash flow from financing activities                        
Proceeds from issuance of shares, net of transaction costs                   —                   —                   —                   —
Proceeds from exercise of share options                   12                     2                 724                 166
Proceeds from borrowings                   —                   —                 579                   —
Proceeds from convertible loans            13,477                   —            13,542                 690
Repayment of lease liability               (235)               (290)               (542)               (861)
                       

Net cash generated by (used in) financing activities
 
        13,254
 
           (288)
 
        14,303
 
               (5)
                         
Net increase/(decrease) in cash and cash equivalents              3,180            (9,092)          (21,807)          (32,360)
                         
Currency effect cash and cash equivalents            (1,474)              1,420            (1,296)              1,572
Cash and cash equivalents, at beginning of the period            87,141            82,464          111,950          105,580
                     
Cash and cash equivalents at the end of the period    88,847    74,792    88,847    74,792


 



Cerence Announces Record Fourth Quarter and Fiscal Year 2020 Results

Fourth
Quarter
and Fiscal Year
Highlights

  • Record bookings in FY20
    drives backlog to
    more than
    $1.8 billion
  • Q4 revenue increased 21% from last
    quarter and
    up 10% from the prior year
    ,
    setting new quarterly and full year record
    s
  • Strong financial performance generated $
    26
    M
    of
    GAAP net cash provided by operating activities
    (CF
    FO
    )
    during the quarter
    and $45M of CFFO for the year
  • Generated adjusted EBITDA of $
    40.3
    M and adjusted EBITDA margin of
    4
    4.
    4
    %
    in the quarter
  • Financial metrics for the fiscal year met or exceeded pre-Covid-19
    full year
    guidance

BURLINGTON, Mass., Nov. 16, 2020 (GLOBE NEWSWIRE) — Cerence Inc. (NASDAQ: CRNC), AI for a world in motion, today reported its fourth quarter and fiscal year 2020 results for the year ended September 30, 2020.

Results
Summary

(1)


(in millions, except per share data)

    Three Months Ended     Twelve Months Ended  
    September 30,     September 30,  
    2020     2019     2020     2019  
GAAP Revenue   $ 90.9     $ 83.0     $ 329.6     $ 303.3  
GAAP Gross Margin     71.8 %     67.4 %     67.3 %     67.2 %
Non-GAAP Gross Margin     75.7 %     70.8 %     71.5 %     70.7 %
GAAP Operating Margin     15.5 %     5.6 %     5.9 %     3.6 %
Non-GAAP Operating Margin     41.9 %     31.3 %     32.1 %     28.7 %
GAAP net income (loss)   $ 6.8     $ 95.8     $ (20.6 )   $ 100.3  
Non-GAAP net income   $ 25.7     $ 19.1     $ 64.3     $ 62.7  
GAAP net income (loss) per share – diluted   $ 0.17     $ 2.63     $ (0.57 )   $ 2.76  
Non-GAAP net income per share – diluted   $ 0.61     $ 0.52     $ 1.68     $ 1.72  
Adjusted EBITDA   $ 40.3     $ 27.8     $ 114.9     $ 94.7  
Adjusted EBITDA margin     44.4 %     33.6 %     34.9 %     31.2 %

(1) Please refer to the “Discussion of Non-GAAP Financial Measures” and “Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures” included elsewhere in this release for more information regarding our use of non-GAAP financial measures. 

Sanjay Dhawan, Chief Executive Officer of Cerence, stated, “Our Q4 financial performance exceeded our expectations for every metric and delivered record revenue, record gross margin and record EBITDA. Cerence’s first year as a stand-alone business established the company as a major player in conversational AI for the car. We had to separate the business from Nuance and deal with the economic impact of Covid-19, but we did so while at the same time continuing a relentless introduction of new products and upgraded technologies. We’re more agile and more aggressive in our approach to innovation and more dedicated to the success of our customers than ever. I’m especially proud of the recognition that the Cerence team has received from our customers regarding our support in helping them achieve their start of production dates without delay.”

Dhawan continued, “Further demonstrating the depth of our customer relationships, we recently signed a renewal agreement for our SaaS-based connected services with a major global automaker, marking the successful renewal of an expiring contract since Cerence became a standalone public company. This contract extension is an important endorsement from a long-time, respected partner on the strength and value of Cerence Connected Services and ensures that we will continue providing cloud-based services for this popular app suite for drivers.”

“As we start the new fiscal year, we are expecting another year of growth supported by a strong backlog and a solid pipeline of new business opportunities. The company’s competitive position remains strong as we rely on innovation and speed of execution to continue to drive our business forward,” Dhawan concluded.

Cerence Key Performance Indicators

To help investors gain further insight into Cerence’s business and its performance, management provides a set of key performance indicators that includes:

Key Performance Indicator

1
  Q4FY20     Q3FY20     Q2FY20     Q1FY20     Q4FY19  
Percent of worldwide auto production with Cerence Technology (TTM)     53 %     54 %     56 %     54 %     54 %
Average contract duration (TTM):   6.1     6.2     5.7     4.9     5.1  
Repeatable software contribution (TTM):     79 %                                
Change in number of Cerence connected cars shipped2 (TTM over prior year TTM)     -16 %                                
Growth in billings per car FY20 vs. prior year (excludes legacy contract)     14 %                                

(1) Please refer to the “Key Performance Indicators” included elsewhere in this release for more information regarding the definition and our use of key performance indicators.
(2) Based on IHS data, global auto production declined 19% over the same time period.



First Quarter Fiscal 2021 and Full Year Outlook


For the fiscal quarter ending December 31, 2020, revenue is expected to be in the range of $85M to $90M representing a 13% increase at the midpoint compared to the same period in the prior year. Adjusted EBITDA is expected to be in the range of $31M to $35M. The adjusted EBITDA guidance excludes acquisition-related costs, amortization of acquired intangible assets, stock-based compensation, and restructuring and other costs. Cerence full-year revenue guidance is for revenue to be in the range of $360M to $380M representing a 12% increase at the midpoint compared to the prior year. Adjusted EBITDA for the full year is expected to be in the range of $122M to $135M. Additional details regarding guidance will be provided on the earnings call.

Fourth
Quarter Conference Call

The company will host a live conference call and webcast with slides to discuss the results at 10:00 a.m. Eastern Time/7:00 a.m. Pacific Time today. Interested investors and analysts are invited to dial into the conference call by using 1.844.467.7116 (domestic) or +1.409.983.9838 (international) and entering the pass code 5673428. Webcast access will be available on the Investor Information section of the company’s website at https://investors.cerence.com/news-and-events/events-and-presentations.

The teleconference replay will be available through December 24, 2020. The replay dial-in number is 1.855.859.2056 (domestic) or +1.404.537.3406 (international) using pass code 5673428. A replay of the webcast can be accessed by visiting our web site 90 minutes following the conference call at https://investors.cerence.com/news-and-events/events-and-presentations.

Forward Looking Statements

Statements in this presentation regarding Cerence’s future performance, results and financial condition, expected growth and innovation and our management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words “believes,” “plans,” “anticipates,” “expects,” “intends” or “estimates” or similar expressions) should also be considered to be forward-looking statements. Although we believe forward-looking statements are based upon reasonable assumptions, such statements involve known and unknown risk, uncertainties and other factors, which may cause actual results or performance of the company to be materially different from any future results or performance expressed or implied by such forward-looking statements including but not limited to: impacts of the Covid-19 pandemic on our and our customer’s businesses; the highly competitive and rapidly changing market in which we operate; adverse conditions in the automotive industry or the global economy more generally; our ability to control and successfully manage our expenses and cash position; our strategy to increase cloud; escalating pricing pressures from our customers; our failure to win, renew or implement service contracts; the loss of business from any of our largest customers; effects of customer defaults; the inability to recruit and retain qualified personnel; cybersecurity and data privacy incidents; fluctuating currency rates; and the other factors in our Annual Report on our most recent Form 10-K, quarterly reports on Form 10-Q, and other filings with the Securities and Exchange Commission. We disclaim any obligation to update any forward-looking statements as a result of developments occurring after the date of this document.

Discussion of
Non-GAAP Financial Measures

We believe that providing the non-GAAP information in addition to the GAAP presentation, allows investors to view the financial results in the way management views the operating results. We further believe that providing this information allows investors to not only better understand our financial performance, but more importantly, to evaluate the efficacy of the methodology and information used by management to evaluate and measure such performance. The non-GAAP information should not be considered superior to, or a substitute for, financial statements prepared in accordance with GAAP.

We utilize a number of different financial measures, both GAAP and non-GAAP, in analyzing and assessing the overall performance of the business, for making operating decisions and for forecasting and planning for future periods. While our management uses these non-GAAP financial measures as a tool to enhance their understanding of certain aspects of our financial performance, our management does not consider these measures to be a substitute for, or superior to, the information provided by GAAP financial statements.

Consistent with this approach, we believe that disclosing non-GAAP financial measures to the readers of our financial statements provides such readers with useful supplemental data that, while not a substitute for GAAP financial statements, allows for greater transparency in the review of our financial and operational performance. In assessing the overall health of the business during the three and twelve months ended September 30, 2020 and 2019, our management has either included or excluded the following items in general categories, each of which is described below.

Adjusted EBITDA

Adjusted EBITDA is defined as net income attributable to Cerence Inc. before net income (loss) attributable to income tax (benefit) expense, other income (expense) items, net, depreciation and amortization expense, and excluding acquisition-related costs, amortization of acquired intangible assets, stock-based compensation, and restructuring and other costs, net or impairment charges related to fixed and intangible assets and gains or losses on the sale of long-lived assets, if any. From time to time we may exclude from Adjusted EBITDA the impact of events, gains, losses or other charges (such as significant legal settlements) that affect the period-to-period comparability of our operating performance. Other income (expense) items, net include interest expense, interest income, and other income (expense), net (as stated in our Consolidated and Combined Statement of Operations). Our management and Board of Directors use this financial measure to evaluate our operating performance. It is also a significant performance measure in our annual incentive compensation programs. 

Restructuring and other costs, net.
Restructuring and other charges, net include restructuring expenses as well as other charges that are unusual in nature, are the result of unplanned events, and arise outside the ordinary course of our business such as employee severance costs, costs for consolidating duplication facilities, and separation costs directly attributable to the Cerence business becoming a standalone public company.

Acquisition-related costs, net.

In recent years, we have completed a number of acquisitions, which result in operating expenses, which would not otherwise have been incurred. We provide supplementary non-GAAP financial measures, which exclude certain transition, integration and other acquisition-related expense items resulting from acquisitions, to allow more accurate comparisons of the financial results to historical operations, forward looking guidance and the financial results of less acquisitive peer companies. We consider these types of costs and adjustments, to a great extent, to be unpredictable and dependent on a significant number of factors that are outside of our control. Furthermore, we do not consider these acquisition-related costs and adjustments to be related to the organic continuing operations of the acquired businesses and are generally not relevant to assessing or estimating the long-term performance of the acquired assets. In addition, the size, complexity and/or volume of past acquisitions, which often drives the magnitude of acquisition related costs, may not be indicative of the size, complexity and/or volume of future acquisitions. By excluding acquisition-related costs and adjustments from our non-GAAP measures, management is better able to evaluate our ability to utilize our existing assets and estimate the long-term value that acquired assets will generate for us. We believe that providing a supplemental non-GAAP measure, which excludes these items allows management and investors to consider the ongoing operations of the business both with, and without, such expenses.

These acquisition-related costs fall into the following categories: (i) transition and integration costs; (ii) professional service fees and expenses; and (iii) acquisition-related adjustments. Although these expenses are not recurring with respect to past acquisitions, we generally will incur these expenses in connection with any future acquisitions. These categories are further discussed as follows:

(i) Transition and integration costs. Transition and integration costs include retention payments, transitional employee costs, and earn-out payments treated as compensation expense, as well as the costs of integration-related activities, including services provided by third-parties.
(ii) Professional service fees and expenses. Professional service fees and expenses include financial advisory, legal, accounting and other outside services incurred in connection with acquisition activities, and disputes and regulatory matters related to acquired entities.
(iii) Acquisition-related adjustments. Acquisition-related adjustments include adjustments to acquisition-related items that are required to be marked to fair value each reporting period, such as contingent consideration, and other items related to acquisitions for which the measurement period has ended, such as gains or losses on settlements of pre-acquisition contingencies.

Amortization of acquired intangible assets. 
We exclude the amortization of acquired intangible assets from non-GAAP expense and income measures. These amounts are inconsistent in amount and frequency and are significantly impacted by the timing and size of acquisitions. Providing a supplemental measure which excludes these charges allows management and investors to evaluate results “as-if” the acquired intangible assets had been developed internally rather than acquired and, therefore, provides a supplemental measure of performance in which our acquired intellectual property is treated in a comparable manner to our internally developed intellectual property. Although we exclude amortization of acquired intangible assets from our non-GAAP expenses, we believe that it is important for investors to understand that such intangible assets contribute to revenue generation. Amortization of intangible assets that relate to past acquisitions will recur in future periods until such intangible assets have been fully amortized. Future acquisitions may result in the amortization of additional intangible assets.

Non-cash expenses.

We provide non-GAAP information relative to the following non-cash expenses: (i) stock-based compensation; and (ii) non-cash interest. These items are further discussed as follows:

(i) Stock-based compensation. Because of varying valuation methodologies, subjective assumptions and the variety of award types, we exclude stock-based compensation from our operating results. We evaluate performance both with and without these measures because compensation expense related to stock-based compensation is typically non-cash and awards granted are influenced by the Company’s stock price and other factors such as volatility that are beyond our control. The expense related to stock-based awards is generally not controllable in the short-term and can vary significantly based on the timing, size and nature of awards granted. As such, we do not include such charges in operating plans. Stock-based compensation will continue in future periods.
(ii) Non-cash interest. We exclude non-cash interest because we believe that excluding this expense provides management, as well as other users of the financial statements, with a valuable perspective on the cash-based performance and health of the business, including the current near-term projected liquidity. Non-cash interest expense will continue in future periods.

Other expenses.

We exclude certain other expenses that result from unplanned events outside the ordinary course of continuing operations, in order to measure operating performance and current and future liquidity both with and without these expenses. By providing this information, we believe management and the users of the financial statements are better able to understand the financial results of what we consider to be our organic, continuing operations. Included in these expenses are items such as other charges (credits), net, losses from extinguishment of debt, and changes in indemnification assets corresponding with the release of pre-spin liabilities for uncertain tax positions.

Backlog.

Revenue backlog consists of the following categories: (i) fixed backlog, (ii) variable backlog, and (iii) total backlog. These categories are further discussed as follows:

(i) Fixed backlog. Future revenue related to remaining performance obligations and contractual commitments which have not been invoiced.
(ii) Variable backlog. Estimated future revenue from variable forecasted royalties related to our embedded and connected businesses. Our estimation of forecasted royalties is based on our royalty rates for embedded and connected technologies from expected car shipments under our existing contracts over the term of the programs. Anticipated shipments are based on historical shipping experience and current customer projections that management believes are reasonable. Both our embedded and connected technologies are priced and sold on a per-vehicle or device basis, where we receive a single fee for either or both the embedded license and the connected service term.
(iii) Total backlog. The total of fixed backlog and variable backlog. 

Our fixed and variable backlog may not be indicative of our actual future revenue. The revenue we actually recognize is subject to several factors, including the number and timing of vehicles our customers ship, potential terminations or changes in scope of customer contracts and currency fluctuations.

Key performance indicators

We believe that providing key performance indicators (“KPIs”), allows investors to gain insight into the way management views the performance of the business. We further believe that providing KPIs allows investors to better understand information used by management to evaluate and measure such performance. KPIs should not be considered superior to, or a substitute for, operating results prepared in accordance with GAAP. In assessing the performance of the business during the three and twelve months ended September 30, 2020 and 2019, our management has reviewed the following KPIs, each of which is described below:

  • Percent of worldwide auto production with Cerence Technology: The number of Cerence enabled cars shipped as compared to IHS Markit car production data.
  • Average contract duration: The weighted average annual period over which we expect to recognize the estimated revenues from new license and connected contracts signed during the quarter, calculated on a trailing twelve months (“TTM”) basis and presented in years.
  • Repeatable software contribution: The percentage of repeatable revenues as compared to total GAAP revenue in the quarter. Repeatable revenues are defined as the sum of License and Connected Services revenues.
  • Change
    in number of Cerence connected
    c
    ars shipped: The year over year change in the number of cars shipped with Cerence connected solutions. Amounts calculated on a TTM basis.
  • Growth in billings
    per
    c
    ar
    FY20
    vs.
    p
    rior
    y
    ear: The rate of growth calculated from the average billings per car in FY20 compared to the prior fiscal year excluding legacy contract and adjusted for prepay usage.

See the tables at the end of this press release for non-GAAP reconciliations to the most directly comparable GAAP measures.

About Cerence Inc.

Cerence (NASDAQ: CRNC) is the global industry leader in creating unique, moving experiences for the automotive world. As an innovation partner to the world’s leading automakers, it is helping transform how a car feels, responds and learns. Its track record is built on more than 20 years of knowledge and more than 325 million cars on the road today. Whether it’s connected cars, autonomous driving or e-vehicles, Cerence is mapping the road ahead. For more information, visit www.cerence.com.

Contact Information

Rich Yerganian
Cerence Inc.
Tel: 617-987-4799
Email: [email protected]

CERENCE INC.

Consolidated and
Combined Statements of Operations

(unaudited – in thousands, except per share data)

    Three Months Ended     Twelve Months Ended  
    September 30,     September 30,  
    2020     2019     2020     2019  
Revenues:                                
License   $ 46,425     $ 45,092     $ 164,268     $ 172,379  
Connected service     25,000       22,860       96,148       78,690  
Professional service     19,457       15,006       69,230       52,246  
Total revenues     90,882       82,958       329,646       303,315  
Cost of revenues:                                
License     439       641       2,783       2,069  
Connected service     7,026       8,971       31,768       37,562  
Professional service     16,190       15,082       64,963       51,214  
Amortization of intangible assets     1,929       2,323       8,337       8,498  
Total cost of revenues     25,584       27,017       107,851       99,343  
Gross profit     65,298       55,941       221,795       203,972  
Operating expenses:                                
Research and development     22,001       23,717       88,899       93,061  
Sales and marketing     8,569       8,786       33,398       36,261  
General and administrative     12,930       8,280       49,386       25,926  
Amortization of intangible assets     3,168       3,127       12,544       12,524  
Restructuring and other costs, net     4,512       7,257       18,237       24,404  
Acquisition-related costs           161             944  
Total operating expenses     51,180       51,328       202,464       193,120  
Income from operations     14,118       4,613       19,331       10,852  
Interest income     22             585        
Interest expense     (3,694 )           (22,737 )      
Other income (expense), net     (2,953 )     231       (23,319 )     332  
Income (loss) before income taxes     7,493       4,844       (26,140 )     11,184  
Provision for (benefit from) income taxes     676       (90,945 )     (5,509 )     (89,084 )
Net income (loss)   $ 6,817     $ 95,789     $ (20,631 )   $ 100,268  
Net income (loss) per share:                                
Basic     0.19       2.63       (0.57 )     2.76  
Diluted     0.17       2.63       (0.57 )     2.76  
Weighted-average common share outstanding:                                
Basic     36,765       36,391       36,428       36,391  
Diluted     39,041       36,391       36,428       36,391  

CERENCE INC.

Consolidated and
Combined Balance Sheets

(unaudited – in thousands, except per share data)

    September 30,     September 30,  
    2020     2019  

ASSETS
               
Current assets:                
Cash and cash equivalents   $ 136,067     $  
Marketable securities     11,662        
Accounts receivable, net of allowances of $1,394 and $865 at September 30, 2020 and September 30, 2019, respectively     49,943       65,787  
Deferred costs     7,256       9,195  
Prepaid expenses and other current assets     44,220       17,343  
Total current assets     249,148       92,325  
Property and equipment, net     29,529       20,113  
Deferred costs     38,161       32,428  
Operating lease right-of-use assets     20,096        
Goodwill     1,128,198       1,119,329  
Intangible assets, net     45,616       65,561  
Deferred tax assets     161,759       150,629  
Other assets     14,938       3,444  
Total assets   $ 1,687,445     $ 1,483,829  

LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:                
Accounts payable   $ 8,447     $ 16,687  
Deferred revenue     112,520       88,233  
Short-term operating lease liabilities     5,700        
Short-term debt     6,250        
Accrued expenses and other current liabilities     67,857       24,194  
Total current liabilities     200,774       129,114  
Long-term debt, net of discounts and issuance costs     266,872        
Deferred revenue, net of current portion     212,573       265,051  
Long-term operating lease liabilities     17,821        
Other liabilities     31,649       21,536  
Total liabilities     729,689       415,701  
Stockholders’ Equity:                
Common stock, $0.01 par value, 560,000 shares authorized as of September 30, 2020; 36,842 shares issued and outstanding as of September 30, 2020     369        
Net parent investment           1,097,127  
Accumulated other comprehensive income (loss)     3,711       (28,999 )
Additional paid-in capital     974,307        
Accumulated deficit     (20,631 )      
Total stockholders’ equity     957,756       1,068,128  
Total liabilities and stockholders’ equity   $ 1,687,445     $ 1,483,829  
                 

CERENCE INC.

Consolidated and
Combined Statements of Cash Flows

(unaudited – in thousands)

    Twelve Months Ended  
    September 30,  
    2020     2019  
Cash flows from operating activities:                
Net (loss) income   $ (20,631 )   $ 100,268  
Adjustments to reconcile net (loss) income to net cash provided by
operating activities:
               
Depreciation and amortization     30,041       28,844  
Provision for doubtful accounts     704        
Stock-based compensation expense     47,285       29,682  
Non-cash interest expense     5,286        
Loss on debt extinguishment     19,279        
Deferred tax benefit     (11,354 )     (101,223 )
Changes in operating assets and liabilities:                
Accounts receivable     16,112       904  
Prepaid expenses and other assets     (30,311 )     (8,836 )
Deferred costs     (1,381 )     4,339  
Accounts payable     (2,430 )     10,130  
Accrued expenses and other liabilities     27,819       6,289  
Deferred revenue     (35,630 )     17,674  
Net cash provided by operating activities     44,789       88,071  
Cash flows from investing activities:                
Capital expenditures     (19,012 )     (4,517 )
Purchases of marketable securities     (11,663 )      
Net cash used in investing activities     (30,675 )     (4,517 )
Cash flows from financing activities:                
Net transactions with Parent     12,964       (83,554 )
Distributions to Parent     (152,978 )      
Proceeds from long-term debt, net of discount     547,719        
Payments for long-term debt issuance costs     (6,402 )      
Principal payments of long-term debt     (271,563 )      
Common stock repurchases for tax withholdings for net settlement of equity awards     (9,369 )      
Principal payments of lease liabilities arising from a finance lease     (136 )      
Proceeds from issuance of common stock from employee stock plans     1,318        
Net cash provided by (used in) financing activities     121,553       (83,554 )
Effects of exchange rate changes on cash and cash equivalents     400        
Net change in cash and cash equivalents     136,067        
Cash and cash equivalents at the beginning of the period            
Cash and cash equivalents at the end of the period   $ 136,067     $  
                 

CERENCE INC.

Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures

(unaudited – in thousands)

    Three Months Ended     Twelve Months Ended  
    September 30,     September 30,  
    2020     2019     2020     2019  
GAAP revenue   $ 90,882     $ 82,958     $ 329,646     $ 303,315  
                                 
GAAP gross profit   $ 65,298     $ 55,941     $ 221,795     $ 203,972  
Stock-based compensation     1,588       436       5,573       1,896  
Amortization of intangible assets     1,929       2,323       8,337       8,498  
Non-GAAP gross profit   $ 68,815     $ 58,700     $ 235,705     $ 214,366  
GAAP gross margin     71.8 %     67.4 %     67.3 %     67.2 %
Non-GAAP gross margin     75.7 %     70.8 %     71.5 %     70.7 %
                                 
GAAP operating income   $ 14,118     $ 4,613     $ 19,331     $ 10,852  
Stock-based compensation     14,331       8,487       47,285       29,682  
Amortization of intangible assets     5,097       5,450       20,881       21,022  
Restructuring and other costs, net     4,512       7,257       18,237       24,404  
Acquisition-related costs           161             944  
Non-GAAP operating income   $ 38,058     $ 25,968     $ 105,734     $ 86,904  
GAAP operating margin     15.5 %     5.6 %     5.9 %     3.6 %
Non-GAAP operating margin     41.9 %     31.3 %     32.1 %     28.7 %
                                 
GAAP net income (loss)   $ 6,817     $ 95,789     $ (20,631 )   $ 100,268  
Stock-based compensation     14,331       8,487       47,285       29,682  
Amortization of intangible assets     5,097       5,450       20,881       21,022  
Restructuring and other costs, net     4,512       7,257       18,237       24,404  
Acquisition-related costs           161             944  
Depreciation     2,255       1,872       9,160       7,822  
Total other income (expense), net     (6,625 )     231       (45,471 )     332  
Provision for (benefit from) income taxes     676       (90,945 )     (5,509 )     (89,084 )
Adjusted EBITDA   $ 40,313     $ 27,840     $ 114,894     $ 94,726  
GAAP net income (loss) margin     7.5 %     115.5 %     -6.3 %     33.1 %
Adjusted EBITDA margin     44.4 %     33.6 %     34.9 %     31.2 %

CERENCE INC.

Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures
(cont.)

(unaudited – in thousands, except per share data)

    Three Months Ended     Twelve Months Ended  
    September 30,     September 30,  
    2020     2019     2020     2019  
GAAP net income (loss)   $ 6,817     $ 95,789     $ (20,631 )   $ 100,268  
Stock-based compensation     14,331       8,487       47,285       29,682  
Amortization of intangible assets     5,097       5,450       20,881       21,022  
Restructuring and other costs, net     4,512       7,257       18,237       24,404  
Acquisition-related costs           161             944  
Loss on debt extinguishment                 19,279        
Non-cash interest expense     1,261             5,286        
Indemnification asset release     1,215             1,215        
Adjustments to income tax expense     (7,501 )     (98,085 )     (27,203 )     (113,584 )
Non-GAAP net income   $ 25,732     $ 19,059     $ 64,349     $ 62,736  
                                 
Adjusted EPS:                                
GAAP Numerator:                                
Net income (loss) attributed to common shareholders   $ 6,817     $ 95,789     $ (20,631 )   $ 100,268  
Interest on Convertible Senior Notes, net of tax                        
Net income (loss) attributed to common shareholders – diluted   $ 6,817     $ 95,789     $ (20,631 )   $ 100,268  
                                 
Non-GAAP Numerator:                                
Net income attributed to common shareholders   $ 25,732     $ 19,059     $ 64,349     $ 62,736  
Interest on Convertible Senior Notes, net of tax     998             1,323        
Net income attributed to common shareholders – diluted   $ 26,730     $ 19,059     $ 65,672     $ 62,736  
                                 
GAAP Denominator:                                
Weighted-average common shares outstanding – basic     36,765       36,391       36,428       36,391  
Adjustment for diluted shares     2,276                    
Weighted-average common shares outstanding – diluted     39,041       36,391       36,428       36,391  
                                 
Non-GAAP Denominator:                                
Weighted-average common shares outstanding- basic     36,765       36,391       36,428       36,391  
Adjustment for diluted shares     6,952             2,747        
Weighted-average common shares outstanding – diluted     43,717       36,391       39,175       36,391  
                                 
GAAP net income (loss) per share – diluted   $ 0.17     $ 2.63     $ (0.57 )   $ 2.76  
Non-GAAP net income per share – diluted   $ 0.61     $ 0.52     $ 1.68     $ 1.72  
                                 
GAAP net cash provided by operating activities   $ 26,212     $ 19,412     $ 44,789     $ 88,071  
Capital expenditures     (2,937 )     (1,649 )     (19,012 )     (4,517 )
Free Cash Flow   $ 23,275     $ 17,763     $ 25,777     $ 83,554  

CERENCE INC.

Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures
(cont.)

(unaudited – in thousands)

    Q4FY20     Q3FY20     Q2FY20     Q1FY20     Q4FY19     Q3FY19     Q2FY19     Q1FY19  
GAAP revenues   $ 90,882       $ 74,810       $ 86,495       $ 77,459       $ 82,958       $ 77,569       $ 70,304     $ 72,484  
Less: Professional services revenue     19,457         17,360         18,742         13,671         15,006         13,891         12,122       11,227  
Non-GAAP Repeatable revenues   $ 71,425       $ 57,450       $ 67,753       $ 63,788       $ 67,952       $ 63,678       $ 58,182     $ 61,257  
                                                                 
GAAP revenues TTM   $ 329,646       $ 321,722       $ 324,481       $ 308,290       $ 303,315       $ 295,713                    
Less: Professional services revenue TTM     69,230         64,779         61,310         54,690         52,246         48,643                    
Non-GAAP Repeatable revenues TTM   $ 260,416       $ 256,943       $ 263,171       $ 253,600       $ 251,069       $ 247,070                    
Repeatable software contribution     79%         80%         81%         82
%
        83
%
        84%                    

CERENCE INC.

Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures
(cont.)

(unaudited – in thousands, except per share data)

    Q1 2021     FY2021  
    Low     High     Low     High  
GAAP revenue   $ 85,000     $ 90,000     $ 360,000     $ 380,000  
                                 
GAAP gross profit   $ 57,500     $ 62,100     $ 248,100     $ 270,100  
Stock-based compensation     1,000       1,000       3,400       3,400  
Amortization of intangible assets     1,900       1,900       7,500       7,500  
Non-GAAP gross profit   $ 60,400     $ 65,000     $ 259,000     $ 281,000  
GAAP gross margin     68 %     69 %     69 %     71 %
Non-GAAP gross margin     71 %     72 %     72 %     74 %
                                 
GAAP operating income   $ 11,300     $ 14,900     $ 48,000     $ 61,900  
Stock-based compensation     9,700       9,700       40,000       40,000  
Amortization of intangible assets     5,000       5,000       20,100       20,100  
Restructuring and other costs, net     2,500       2,500       3,600       3,600  
Non-GAAP operating income   $ 28,500     $ 32,100     $ 111,700     $ 125,600  
GAAP operating margin     13 %     17 %     13 %     16 %
Non-GAAP operating margin     34 %     36 %     31 %     33 %
                                 
GAAP net income   $ 5,600     $ 9,300     $ 17,900     $ 30,900  
Stock-based compensation     9,700       9,700       40,000       40,000  
Amortization of intangible assets     5,000       5,000       20,100       20,100  
Restructuring and other costs, net     2,500       2,500       3,600       3,600  
Depreciation     2,500       2,500       9,400       9,400  
Total other income (expense), net     (3,700 )     (3,700 )     (14,500 )     (14,500 )
Provision for income taxes     1,900       1,900       16,500       16,500  
Adjusted EBITDA   $ 30,900     $ 34,600     $ 122,000     $ 135,000  
GAAP net income margin     7 %     10 %     5 %     8 %
Adjusted EBITDA margin     36 %     38 %     34 %     36 %

CERENCE INC.

Reconciliations of GAAP Financial Measures to Non-GAAP Financial Measures
(cont.)

(unaudited – in thousands, except per share data)

    Q1 2021     FY2021  
    Low     High     Low     High  
GAAP net income   $ 5,600     $ 9,300     $ 17,900     $ 30,900  
Stock-based compensation     9,700       9,700       40,000       40,000  
Amortization of intangible assets     5,000       5,000       20,100       20,100  
Restructuring and other costs, net     2,500       2,500       3,600       3,600  
Non-cash interest expense     1,200       1,200       5,000       5,000  
Income tax impact of Non-GAAP adjustments     (4,300 )     (5,200 )     (10,500 )     (13,100 )
Non-GAAP net income   $ 19,700     $ 22,500     $ 76,100     $ 86,500  
                                 
Adjusted EPS:                                
GAAP Numerator:                                
Net income attributed to common shareholders   $ 5,600     $ 9,300     $ 17,900     $ 30,900  
Interest on Convertible Senior Notes, net of tax     1,005       1,005       3,987       3,987  
Net income attributed to common shareholders – diluted   $ 6,605     $ 10,305     $ 21,887     $ 34,887  
                                 
Non-GAAP Numerator:                                
Net income attributed to common shareholders   $ 19,700     $ 22,500     $ 76,100     $ 86,500  
Interest on Convertible Senior Notes, net of tax     1,005       1,005       3,987       3,987  
Net income attributed to common shareholders – diluted   $ 20,705     $ 23,505     $ 80,087     $ 90,487  
                                 
GAAP Denominator:                                
Weighted-average common shares outstanding – basic     37,221       37,221       38,302       38,302  
Adjustment for diluted shares     5,818       5,818       5,888       5,888  
Weighted-average common shares outstanding – diluted     43,039       43,039       44,190       44,190  
                                 
Non-GAAP Denominator:                                
Weighted-average common shares outstanding- basic     37,221       37,221       38,302       38,302  
Adjustment for diluted shares     5,818       5,818       5,888       5,888  
Weighted-average common shares outstanding – diluted     43,039       43,039       44,190       44,190  
                                 
GAAP net income per share – diluted   $ 0.15     $ 0.24     $ 0.50     $ 0.79  
Non-GAAP net income per share – diluted   $ 0.48     $ 0.55     $ 1.81     $ 2.05  



Inivata Appoints Dr. Alan Schafer as Chief Technology Officer

Inivata Appoints Dr. Alan Schafer as Chief Technology Officer

Research Triangle Park, NC, USA and Cambridge, UK, 16 November 2020 – Inivata, a leader in liquid biopsy, today announces the appointment of Dr. Alan Schafer as Chief Technology Officer (CTO), effective immediately. Alan will lead the development of Inivata’s leading InVision® liquid biopsy technology platform and new product development.

Alan brings to the role over 25 years of genetics and molecular diagnostics experience. He was previously CEO of 14M Genomics, a cancer molecular diagnostics company, and prior to that served as CEO of Population Genetics Technologies, a business specialising in infectious disease diagnostics and next-generation sequencing technologies. Earlier roles include those of Global VP Technology Development at GlaxoSmithKline and VP Genetics at Incyte. More recently, Alan has worked as an independent consultant for the biotechnology industry, academia and the investment community, offering his expertise in genomic and biology technologies with a particular focus on the interface between science, technology and business. Alan holds a PhD from the University of Southern California and has authored numerous publications in the molecular genetics field.

Clive Morris, Chief Executive Officer of Inivata, commented: Alan’s appointment to the leadership team reflects our commitment to continuing to advance our cutting-edge liquid biopsy technology platform. He brings a wealth of experience in molecular diagnostics which will help to ensure that we remain at the forefront of innovation in the space as we drive our platform closer to patients in need.”

Alan Schafer
, Chief Technology Officer of Inivata, commented: “Inivata’s pioneering technology offers the potential to transform the lives of cancer patients, and it is a very exciting time to join the company as it rolls out the RaDaR assay for the detection of residual disease and recurrence. This is clearly a key area of focus for potential biopharma partners and I look forward to working with the rest of the executive team to drive forward Inivata’s strategy.”  

About Inivata

Inivata is a leader in liquid biopsy. Its InVision® platform unlocks essential genomic information from a simple blood draw to guide and personalize cancer treatment, monitor response and detect relapse. Inivata’s technology is based on pioneering research from the Cancer Research UK Cambridge Institute, University of Cambridge. Its lead product, InVisionFirst®-Lung is commercially available internationally and through NeoGenomics in the US. It offers competitive sensitivity and turnaround, providing molecular insights that enable clinicians to make more informed treatment decisions for advanced NSCLC patients. Inivata has also launched the personalized RaDaR™ assay – allowing the highly sensitive detection of residual disease and recurrence. Inivata is partnering with pharmaceutical, biotechnology companies and commercial partners in a range of early and late stage cancer development programs. The Company has a CLIA certified, CAP accredited laboratory in Research Triangle Park, NC and R&D laboratories in Cambridge, UK. For more information, please go to www.inivata.com. Follow Inivata on Twitter @Inivata.

Media Contacts:

Consilium Strategic Communications
Chris Gardner/Angela Gray/Sarah Wilson
Paul Kidwell (US)
[email protected] +44 (0)20 3709 5700, +1 516 503 0271

Karen Chandler-Smith
[email protected] +44 (0)7900 430235



Mereo BioPharma to Hold Virtual R&D Day on Tuesday, November 24, 2020

LONDON and REDWOOD CITY, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Mereo BioPharma Group plc (NASDAQ: MREO, AIM: MPH) (“Mereo” or “the Company”), a clinical stage biopharmaceutical company focused on oncology and rare diseases, today announced it will host a virtual R&D day on Tuesday, November 24, to review the Company’s key pipeline programs including etigilimab (Anti-TIGIT) for solid tumors and alvelestat for alpha-1 antitrypsin deficiency (AATD) and COVID-19 respiratory disease. The virtual R&D day will feature external experts and will include a more detailed review of the etigilimab development program, including the design and biomarker strategy for the recently initiated Phase 1b/2 basket combination study.


R&D Day Information

Date: Tuesday, November 24, 2020

Time: 12:00 p.m. EST / 5:00 p.m. GMT

Presenters:

  • Timothy Yap, MBBS, PhD, FRCP, Associate Professor, Department of Investigational Cancer Therapeutics, and the Department of Thoracic/Head and Neck Medical Oncology, The University of Texas MD Anderson Cancer Center
  • John Strickler, MD, Associate Professor of Medicine, Member of the Duke Cancer Institute
  • Mark Dransfield, MD, Professor and Interim Director, Division of Pulmonary, Allergy and Critical Care Medicine, The University of Alabama at Birmingham (UAB)
  • Denise Scots-Knight, Chief Executive Officer
  • John Lewicki, Chief Scientific Officer
  • Ann Kapoun, SVP of Translational Research and Development
  • Alastair MacKinnon, Chief Medical Officer
  • Jackie Parkin, Head of the Alvelestat Program

A live audio webcast of the R&D day can be accessed through the Investors section of the company’s website at www.mereobiopharma.com/investors/results-reports-and-presentations. The event is expected to last approximately two hours. An archived replay of the webcast will be made available on the Company’s website.

About
Mereo
BioPharma

Mereo BioPharma is a biopharmaceutical company focused on the development and commercialization of innovative therapeutics that aim to improve outcomes for oncology and rare diseases. Mereo’s lead oncology product candidate, etigilimab (Anti-TIGIT), has completed a Phase 1a dose escalation clinical trial in patients with advanced solid tumors and has been evaluated in a Phase 1b study in combination with nivolumab in select tumor types. The Company recently announced initiation of a Phase 1b/2 study of etigilimab in combination with an anti-PD-1/PDL-1 in a range of different tumor types. Mereo’s rare disease product portfolio consists of setrusumab, which has completed a Phase 2b dose-ranging study in adults with osteogenesis imperfecta (OI), as well as alvelestat, which is being investigated in a Phase 2 proof-of-concept clinical trial in patients with alpha-1 antitrypsin deficiency (AATD) and in a Phase 1b/2 clinical trial in COVID-19 respiratory disease.

Forward-Looking Statements

This Announcement contains “forward-looking statements.” All statements other than statements of historical fact contained in this Announcement are forward-looking statements within the meaning of Section 27A of the United States Securities Act of 1933, as amended and Section 21E of the United States Securities Exchange Act of 1934, as amended. Forward-looking statements usually relate to future events and anticipated revenues, earnings, cash flows or other aspects of our operations or operating results. Forward-looking statements are often identified by the words “believe,” “expect,” “anticipate,” “plan,” “intend,” “foresee,” “should,” “would,” “could,” “may,” “estimate,” “outlook” and similar expressions, including the negative thereof. The absence of these words, however, does not mean that the statements are not forward-looking. These forward-looking statements are based on the Company’s current expectations, beliefs and assumptions concerning future developments and business conditions and their potential effect on the Company. While management believes that these forward-looking statements are reasonable as and when made, there can be no assurance that future developments affecting the Company will be those that it anticipates.

All of the Company’s forward-looking statements involve known and unknown risks and uncertainties some of which are significant or beyond its control and involve assumptions that could cause actual results to differ materially from the Company’s historical experience and its present expectations or projections. 

These forward-looking statements are subject to risks and uncertainties, including, among other things, those described in the Company’s latest Annual Report on Form 20-F, Reports on Form 6-K and other documents filed from time to time by the Company with the United States Securities and Exchange Commission. The Company wishes to caution investors not to place undue reliance on any forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Mereo
BioPharma
Contacts:

Mereo +44 (0)333 023 7300
Denise Scots-Knight, Chief Executive Officer  
   
N+1 Singer (Nominated Adviser and Broker to 
Mereo
)
+44 (0)20 7496 3081
Phil Davies  
Will Goode  
   
Burns McClellan (US Investor Relations Adviser to 
Mereo
)
+01 212 213 0006
Lisa Burns  
Lee Roth  
   
FTI Consulting (UK Public Relations Adviser to 
Mereo
)
 +44 (0)20 3727 1000
Simon Conway  
Ciara Martin  
   
Investors investors@

mereo

biopharma.com



XL Fleet Expands XLP™ Plug-in Hybrid Electric Drive System For Use in Multiple GM Fleet Applications

XL Fleet Expands XLP™ Plug-in Hybrid Electric Drive System For Use in Multiple GM Fleet Applications

Second-Generation Upfit Technology to be Offered on Chevrolet and GMC Commercial Pickups and Cutaway Chassis; Expected to Begin Shipping in Early 2021

BOSTON–(BUSINESS WIRE)–
XL Fleet (“XL” or the “Company”), a leader in vehicle electrification solutions for commercial and municipal fleets, has announced that the Company’s XLP™ plug-in hybrid electric drive technology is being expanded for use across a range of fleet vehicles from General Motors (NYSE: GM). The platform is expected to begin shipping on select configurations of the Chevrolet and GMC Silverado / Sierra 2500 HD and 3500 HD pickup trucks in the first quarter of 2021, and on Chevrolet and GMC 3500 and 4500 cutaway chassis in the second quarter of 2021.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005434/en/

XL's plug-in hybrid electric drive technology can now be installed onto a range of commercial fleet vehicles from General Motors, including popular Silverado and Sierra pickup trucks. (Photo: XL Fleet)

XL’s plug-in hybrid electric drive technology can now be installed onto a range of commercial fleet vehicles from General Motors, including popular Silverado and Sierra pickup trucks. (Photo: XL Fleet)

The Company’s newest product offering expands its growing lineup of plug-in hybrid electric drive systems, which can improve fuel economy by increasing miles per gallon by up to 50% and reducing CO2 emissions by approximately one-third compared to traditional gas-powered vehicles. It is also the Company’s first plug-in hybrid system to be available for Chevrolet and GMC fleet vehicles, adding to a broad range of XL hybrid systems currently available for GM products.

“GM Fleet vehicles are built to meet the rigorous performance requirements of today’s most demanding applications,” said Jim Connelly, Manager of Commercial & Specialty Vehicles, GM Fleet. “Adding XL’s plug-in hybrid electric upfit technology to these tried-and-true GM Fleet vehicles can provide a tested and flexible option for customers looking to electrify their work truck applications immediately.”

These new product offerings further expand XL’s reach into a wide range of mission-critical electrified fleet applications, including electric utilities, emergency response units, last mile delivery vehicles and other highly specialized and demanding applications. The Company believes its expanded portfolio will further extend its leadership position in fleet electrification.

“Companies and municipalities are focused on electrifying a larger percentage of their fleets, while ensuring they uphold their performance and operational requirements,” said Tod Hynes, Founder and Chief Strategy Officer of XL Fleet. “XL’s ability to electrify a wide range of commercial applications from the world’s leading vehicle manufacturers allows us to immediately serve this market with proven, high performance vehicles that are already designed and specified for the rigorous duty cycles of fleets.”

“By leveraging our experience with over 200 customers and utilizing proprietary data from nearly 140 million customer miles driven, we are uniquely positioned to quickly and efficiently develop solutions for applications with significant demand,” said Dimitri Kazarinoff, Chief Executive Officer of XL Fleet. “The launch of our plug-in hybrid electric upfit technology for the GM family of high-performance fleet vehicles represents an exciting expansion of our work with GM Fleet as well as our growing line of plug-in hybrid electric solutions. This new platform incorporates XL’s second-generation plug-in hybrid electric drive technology, providing higher kilowatt-hours with a more scalable design that can be expanded onto a much broader array of vehicles and applications.”

XL remains on track to complete its previously announced merger agreement with Pivotal Investment Corporation II (NYSE: PIC), a publicly traded special purpose acquisition company, in the fourth quarter of 2020. Upon closing, the combined company will be named XL Fleet Corp. and is expected to remain listed on the New York Stock Exchange under a new ticker symbol, “XL”.

About XL Fleet

XL Fleet is a leading provider of vehicle electrification solutions for commercial and municipal fleets in North America, with more than 130 million miles driven by customers such as The Coca-Cola Company, Verizon, Yale University and the City of Boston. XL’s hybrid and plug-in hybrid electric drive systems can increase fuel economy up to 25-50 percent and reduce carbon dioxide emissions up to 20-33 percent, decreasing operating costs and meeting sustainability goals while enhancing fleet operations. XL’s plug-in hybrid electric drive system was named one of TIME magazine’s best inventions of 2019.

For additional information, please visit www.xlfleet.com.

About Pivotal Investment Corporation II

Pivotal Investment Corporation II (NYSE: PIC) is a special purpose acquisition company organized for the purpose of effecting a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization, or other similar business combination with one or more businesses or entities. On September 18, 2020, Pivotal announced that it had entered into a definitive merger agreement with XL Fleet. Upon closing, the combined company will be named XL Fleet and is expected to remain listed on the New York Stock Exchange under a new ticker symbol, “XL”. For additional information, please visit https://www.pivotalic.com/.

Important Information and Where to Find It

This communication is being made in respect of the proposed merger transaction involving Pivotal and XL. Pivotal filed a registration statement on Form S-4 with the Securities and Exchange Commission (the “SEC”), which includes a proxy statement/prospectus of Pivotal, and certain related documents, to be used at the meeting of shareholders to approve the proposed business combination and related matters. INVESTORS AND SECURITY HOLDERS OF PIVOTAL ARE URGED TO READ THE PROXY STATEMENT/PROSPECTUS, AND ANY AMENDMENTS THERETO AND OTHER RELEVANT DOCUMENTS THAT WILL BE FILED WITH THE SEC, CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT XL, PIVOTAL AND THE BUSINESS COMBINATION. The definitive proxy statement will be mailed to shareholders of Pivotal as of a record date to be established for voting on the proposed business combination. Investors and security holders will also be able to obtain copies of the registration statement and other documents containing important information about each of the companies once such documents are filed with the SEC, without charge, at the SEC’s web site at www.sec.gov.

The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release.

Participants in the Solicitation

Pivotal, XL and certain of their respective directors and executive officers may be deemed participants in the solicitation of proxies from the shareholders of Pivotal in favor of the approval of the business combination and related matters. Shareholders may obtain more detailed information regarding the names, affiliations and interests of certain of Pivotal’s executive officers and directors in the solicitation by reading Pivotal’s Annual Report on Form 10-K for the fiscal year ended December 31, 2019, and the proxy statement and other relevant materials filed with the SEC in connection with the business combination when they become available. Information concerning the interests of Pivotal’s participants in the solicitation, which may, in some cases, be different than those of their stockholders generally, will be set forth in the proxy statement relating to the business combination when it becomes available.

No Offer or Solicitation

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of such other jurisdiction.

Forward Looking Statements

The information in this press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of present or historical fact included in this press release regarding XL Fleet’s new product offerings, the proposed business combination, including Pivotal’s ability to consummate the transaction, the anticipated timing of the closing of the business combination and benefits of the transaction, and the combined company’s future financial performance, as well as the combined company’s strategy, future operations, estimated financial position, estimated revenues and losses, projected costs, prospects, plans and objectives of management, are forward-looking statements. Forward-looking statements are inherently subject to risks, uncertainties and assumptions. These statements may be preceded by, followed by or include the words “anticipates,” “believes,” “estimates,” “expects,” “projects,” “forecasts,” “may,” “will,” “should,” “seeks,” “plans,” “scheduled,” “anticipates” or “intends” or similar expressions. Such forward-looking statements involve risks and uncertainties that may cause actual events, results or performance to differ materially from those indicated by such statements. Certain of these risks are identified and discussed in Pivotal’s Annual Report on Form 10-K for the year ended December 31, 2019 under Risk Factors in Part I, Item 1A and in Pivotal’s Quarterly Reports on Form 10-Q for the quarters ended June 30, 2020 and September 30, 2020. These risk factors will be important to consider in determining future results and should be reviewed in their entirety. These forward-looking statements are expressed in good faith, and Pivotal and XL believe there is a reasonable basis for them. However, there can be no assurance that the events, results or trends identified in these forward-looking statements will occur or be achieved. Forward-looking statements speak only as of the date they are made, and neither Pivotal nor XL is under any obligation, and expressly disclaim any obligation, to update, alter or otherwise revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. Readers should carefully review the statements set forth in the reports, which Pivotal has filed or will file from time to time with the SEC.

In addition to factors previously disclosed in Pivotal’s reports filed with the SEC and those identified elsewhere in this communication, the following factors, among others, could cause actual results to differ materially from forward-looking statements or historical performance: the parties’ ability to meet the closing conditions to the merger, including approval by stockholders of Pivotal and XL on the expected terms and schedule and the risk that regulatory approvals required for the merger are not obtained or are obtained subject to conditions that are not anticipated; delay in closing the merger or the PIPE Offering; failure to realize the benefits expected from the proposed transaction; the effects of pending and future legislation; risks related to disruption of management time from ongoing business operations due to the proposed transaction; business disruption following the transaction; other consequences associated with mergers, acquisitions and divestitures and legislative and regulatory actions and reforms; risks associated with XL’s business, including the highly competitive nature of XL’s business and the market for hybrid electric vehicles; litigation, complaints, product liability claims and/or adverse publicity; cost increases or shortages in the components necessary to support XL’s products and services; the introduction of new technologies; privacy and data protection laws, privacy or data breaches, or the loss of data; and the impact of the COVID-19 pandemic on XL’s business, results of operations, financial condition, regulatory compliance and customer experience.

Any financial projections in this communication are forward-looking statements that are based on assumptions that are inherently subject to significant uncertainties and contingencies, many of which are beyond Pivotal’s and XL’s control. While all projections are necessarily speculative, Pivotal and XL believe that the preparation of prospective financial information involves increasingly higher levels of uncertainty the further out the projection extends from the date of preparation. The assumptions and estimates underlying the projected results are inherently uncertain and are subject to a wide variety of significant business, economic and competitive risks and uncertainties that could cause actual results to differ materially from those contained in the projections. The inclusion of projections in this communication should not be regarded as an indication that Pivotal and XL, or their respective representatives and advisors, considered or consider the projections to be a reliable prediction of future events.

This communication is not intended to be all-inclusive or to contain all the information that a person may desire in considering in an investment in Pivotal and is not intended to form the basis of an investment decision in Pivotal. All subsequent written and oral forward-looking statements concerning Pivotal and XL, the proposed transactions or other matters and attributable to Pivotal and XL or any person acting on their behalf are expressly qualified in their entirety by the cautionary statements above.

For XL Fleet

Media:

Eric Foellmer

(617) 648-8551

[email protected]

Investors:

ICR, Inc.

[email protected]

For Pivotal Investment Corporation II

Jonathan Gasthalter/Nathaniel Garnick/Sam Fisher

Gasthalter & Co.

(212) 257-4170

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Alternative Vehicles/Fuels Fleet Management Other Automotive General Automotive Automotive

MEDIA:

Photo
Photo
XL’s plug-in hybrid electric drive technology can now be installed onto a range of commercial fleet vehicles from General Motors, including popular Silverado and Sierra pickup trucks. (Photo: XL Fleet)
Logo
Logo

SG Blocks to Reschedule Third Quarter Financial Results Conference Call

SG Blocks to Reschedule Third Quarter Financial Results Conference Call

BROOKLYN, N.Y.–(BUSINESS WIRE)–SG Blocks, Inc. (Nasdaq: SGBX) (“SG Blocks” or the “Company”), a leading designer, innovator and fabricator of container-based structures, announced today it plans to reschedule the release of its financial results for the third fiscal quarter, which ended September 30, 2020. The call had been originally scheduled for November 16, 2020. More information on the revised conference call will be provided in the future.

This change will provide the Company with additional time to complete certain information required for its Quarterly Report on Form 10-Q for its third fiscal quarter of 2020.

SG Blocks intends to file its Quarterly Report on Form 10-Q for its third fiscal quarter of 2020 on or before the same date as the rescheduled earnings call, once determined.

About SG Blocks:

SG Blocks, Inc. is a premier innovator in advancing and promoting the use of code-engineered cargo shipping containers for safe and sustainable construction. The firm offers a product that exceeds many standard building code requirements, and also supports developers, architects, builders and owners in achieving greener construction, faster execution, and stronger buildings of higher value. Each project starts with GreenSteelTM, the structural core and shell of an SG Blocks building, and then customized to client specifications. For more information, visit www.sgblocks.com.

Media:

Rubenstein Public Relations

Christina Levin

Account Director

212-805-3029

[email protected]

Investors:

Stephen Swett

(203) 682-8377

[email protected]

KEYWORDS: United States North America New York

INDUSTRY KEYWORDS: Architecture Other Construction & Property Manufacturing Commercial Building & Real Estate Construction & Property Other Manufacturing Steel

MEDIA:

OLB Offers Payment Processing Options for Cannabis and CBD Merchants

OLB Offers Payment Processing Options for Cannabis and CBD Merchants

Citing Mew Regulatory Environment For Banks, OLB Will Provide A Safe Alternative To Cash-Only For CBD Merchants

NEW YORK–(BUSINESS WIRE)–The OLB Group, Inc. (NASDAQ: OLB), a provider of cloud-based omnicommerce and payment acceptance solutions for small- and mid-sized merchants, announced its SecurePay payment gateway and OmniSoft cloud-based business management platform are ready to support merchants selling cannabis- and hemp-derived products, including CBD. The services will be available to merchants as soon as U.S. regulators allow.

A patchwork of legalization across the U.S., combined with federal banking restrictions, have limited bank involvement with CBD and cannabis sellers. But the relaxation of federal administrative rules in 2020, along with the recent approval by voters for legalizing CBD products in multiple states, have encouraged banks to pursue business in this sector.

“Both the legislative and administrative hurdles to offering banking solutions to CBD and cannabis distributors have been removed in 2020, and banks are now stepping up efforts to attract these merchants into their programs,” said Ronny Yakov, chief executive officer of OLB. “As soon as banks are ready to approve these merchants, OLB is prepared to onboard and support their transition from a cash-based payment acceptance process to an omnicommerce business model that includes multiple payment modalities, as well as full-featured business automation and management capabilities.”

OLB’s SecurePay payment gateway platform offers support for traditional card-based payment processing as well as new models, including QR-code, mobile app solutions such as Apple Pay and Google Pay, and automated clearing house (ACH) account-to-account transfers.

In addition, OLB’s OmniSoft business management platform offers merchants a broad range of tools to market, operate, and manage their business. Available features include web-builder tools, e-commerce, in-store, and mobile sales tools, marketing templates and campaigns, and a variety of back-office features for order management and fulfillment, warehouse and inventory operations, and integrated bookkeeping support.

Merchants, including those in the cannabis and CBD sector, interested in implementing omnicommerce services can set up an account at https://cardaccept.com/#contact.

For more information about The OLB Group, please visit www.olb.com and www.olb.com/investors-data.

Investor Database for Future Press Releases and Industry Updates

Interested investors and shareholders are invited to be added to the corporate email database for corporate press releases and industry updates by sending an email to [email protected].

Safe Harbor Statement

All statements from The OLB Group, Inc. in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements concerning the impact of COVID-19 on our operations and financial condition our ability to implement our proprietary merchant boarding and CRM system and to roll out our Omni Commerce applications to our current merchants and the integration of our secure payment gateway with our crowdfunding platform. While the Company’s management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of our control, that could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include statements regarding the expected revenue and income for operations to be generated by The OLB Group, Inc. For other factors that may cause our actual results to differ from those that are expected, see the information under the caption “Risk Factors” in the Company’s most recent Form 10-K and 10-Q filings, and amendments thereto, as well as other public filings with the SEC since such date. The Company operates in a rapidly changing and competitive environment, and new risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statement.

About The OLB Group, Inc.

The OLB Group, Inc. is a payment facilitator and commerce service provider that delivers cloud-based merchant services for web-based and brick-and-mortar organizations. OLB provides a seamless, end-to-end digital commerce solution that includes site creation, hosting, transaction processing and payment gateway, order fulfillment, customer service, outbound marketing, sales reporting, and fundraising. With services from private label shopping sites designed to maintain the unique look or feel of the merchant website, to order fulfillment and customer service, OLB remains invisible to the user and promotes the merchant’s brand with market-leading technology and solutions. For more information about solutions, services, or to find a reseller, please visit www.olb.com. Investor information is available at www.olb.com/investors-data.

Glenn Goldberg

Parallel Communications, Inc.

[email protected]

(516) 705-6116

The OLB Group – Investor Relations

Rick Lutz

[email protected]

(212) 278-0900 EXT: 333

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Software Banking Online Retail Professional Services Data Management Technology Small Business Security Retail Alternative Medicine Finance Health

MEDIA:

Logo
Logo

Titan Medical Reports Third Quarter Financial Results

Titan Medical Reports Third Quarter Financial Results

TORONTO–(BUSINESS WIRE)–Titan Medical Inc. (“Titan” or the “Company”) (TSX: TMD) (Nasdaq: TMDI), a medical device company focused on the design and development of surgical technologies for robotic single access surgery, announces financial results for the three and nine months ended September 30, 2020, highlighted by the Company’s improved cash position, which, as of September 30, 2020, reflects a positive difference of approximately $24 million compared to its cash position at December 31, 2019.

All financial results are prepared in accordance with International Accounting Standards (“IAS”) 34 on a basis consistent with the Company’s 2019 annual financial statements and are reported in U.S. dollars, unless otherwise stated. The unaudited condensed interim consolidated financial statements and management’s discussion and analysis for the period ended September 30, 2020 may be viewed at www.sedar.com and at www.sec.gov.

“Titan made significant progress during the third quarter of this year. We recommenced the development of our robotic single access surgical system, unveiled ‘Enos’ as its new brand name, and updated our corporate identity. Today, we are proud to launch our revamped website reflecting the new branding,” said David McNally, President and Chief Executive Officer of Titan. “During the quarter we also continued with the development activities commenced in mid-June under the development and license agreement with Medtronic, leading to the on-schedule and successful completion of the first technical milestone in October 2020. This first phase of the program was an intensive four-month effort and the results are a testament to the expertise and the innovative culture of our in-house and partner service provider teams.”

Demonstrating the Company’s commitment to more frequent shareholder communications, a video of recent highlights presented by David McNally is on the Company’s website at https://www.titanmedicalinc.com/videos/.

Business highlights for the third quarter of 2020 and recent weeks include:

  • On July 30, the Company announced that it had completed design enhancements to the instruments for the Enos™ robotic single access surgical system, which are expected to improve strength, agility, movement efficiency, and durability for reprocessing, while potentially reducing manufacturing costs.
  • David McNally, President and CEO of Titan, presented at three conferences including: on August 1, at the plenary session of the Society of Robotic Surgery 2020 World Robotic Symposium; on September 2, at the LD Micro LD 500 Virtual Conference for microcap companies with valuations up to $300 million; and on September 14, at the H.C. Wainwright 22nd Annual Global Investor Conference.
  • Continued expansion of the Company’s intellectual property portfolio, with the issuance of certain robotic surgery patents related to camera and system control as announced on September 17, and additional issuances and filings bringing the Company’s totals to 59 issued patents and 85 applications pending as of September 30.
  • On September 21, the Company revealed the new Enos robotic single access surgical system brand identity, replacing the SPORT brand identity.
  • An ISO 13485:2016 surveillance audit was successfully completed in September by TÜV SÜD, the Company’s European Notified Body.
  • On September 30, Stephen Randall, CFO of Titan, retired after serving more than 10 years with the Company, and effective October 1, Monique L. Delorme was promoted to CFO from VP of Finance.
  • On October 7, following approval by shareholders at its Annual and Special Meeting of Shareholders, the Company announced the election of Paul Cataford, Anthony J. Giovinazzo and Cary G. Vance to the Board of Directors.
  • On October 26, the Company announced the on-schedule accomplishment of the first technical milestone pursuant to the Medtronic development and license agreement, and on October 28, received the related $10 million license payment.
  • As of November 16, the Company has increased its office and lab space for the growing product development team at its subsidiary, Titan Medical USA Inc., in Chapel Hill, North Carolina. Drawing talent from the Research Triangle Park area, the team has grown to 8 technical experts who are focused on advancing the Enos system, including software development and implementation of enhancements to its camera systems, multi-articulated instruments, and patient cart.

Financial results for the three and nine months ended September 30, 2020 include:

  • Net and comprehensive losses for the three and nine months ended September 30, 2020 were $1,640,633 and $3,551,875, compared with net and comprehensive losses of $1,564,196 and $44,319,942, for the three and nine months ended September 30, 2019, respectively. In addition to reduced R&D expenses, the results include recognition in June 2020 of $10 million in revenue from a license agreement with Medtronic, and a gain on settlement of a supplier claim. Further, both the three and nine months ended September 30, 2020 were impacted, as compared to the prior periods, by the changes in the valuation of outstanding warrants.
  • Research and development (“R&D”) expenses for the three and nine months ended September 30, 2020 were $2,265,975 and $2,433,557, respectively, compared with R&D expenses of $16,570,480 and $49,339,766, respectively for the corresponding prior-year periods, as the Company suspended product development during the first half of 2020 due to insufficiency of available capital. The Company has since resumed its R&D program beginning in July 2020.
  • Cash and cash equivalents as of September 30, 2020 were $24,675,913, compared with cash and cash equivalents of $814,492 as of December 31, 2019. At September 30, 2020, current liabilities, excluding warrant liability were $9,416,241 compared with $11,433,967 as of December 31, 2019.
  • At September 30, 2020, the Company had working capital of $16,523,569 compared to a working capital deficit of $9,684,525 at December 31, 2019.

About Titan

Titan Medical Inc., a medical device company headquartered in Toronto, is focused on developing robotic assisted technologies for application in single access surgery. The Enos™ system, by Titan Medical, is being developed to become the new standard of care in robotic single access surgery with dual 3D and 2D high-definition vision systems, multi-articulating instruments, and an ergonomic surgeon workstation. With the Enos system, Titan intends to initially pursue gynecologic surgical indications.

Certain of Titan’s robotic assisted surgical technologies and related intellectual property have been licensed to Medtronic plc, while retaining world-wide rights to commercialize the technologies for use with the Enos system.

Enos™ is a trademark of Titan Medical Inc.

For more information, visit www.titanmedicalinc.com.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of applicable Canadian and U.S. securities laws. Such statements reflect the current expectations of management of the Company’s future growth, results of operations, performance and business prospects and opportunities. Wherever possible, words such as “may”, “would”, “could”, “will”, “anticipate”, “believe”, “plan”, “expect”, “intend”, “estimate”, “potential for” and similar expressions have been used to identify these forward-looking statements, including references to: the Company being focused on the design and development of surgical technologies for robotic single access surgery; the design enhancements to the instruments of the Enos system which are expected to improve strength, agility, movement efficiency, and durability for reprocessing, while potentially reducing manufacturing costs; the Enos system being developed to become the new standard of care in robotic single access surgery with dual 3D and 2D high-definition vision systems, multi-articulating instruments, and an ergonomic surgeon workstation; Titan’s intention to initially pursue gynecologic surgical indications with the Enos system; the license of certain of Titan’s robotic assisted surgical technologies and related intellectual property to Medtronic plc, while retaining world-wide rights to commercialize the technologies for use with the Enos system. These statements reflect management’s current beliefs with respect to future events and are based on information currently available to management. Forward-looking statements involve significant risks, uncertainties and assumptions. Many factors could cause the Company’s actual results, performance or achievements to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, without limitation, those listed in the “Risk Factors” section of the Company’s Annual Report on Form 20F dated March 30, 2020 (which may be viewed at www.sedar.com and at www.sec.gov). Should one or more of these risks or uncertainties materialize, or should assumptions underlying the forward-looking statements prove incorrect, actual results, performance, or achievements may vary materially from those expressed or implied by the forward-looking statements contained in this news release. These factors should be considered carefully, and prospective investors should not place undue reliance on the forward-looking statements. Although the forward-looking statements contained in the news release are based upon what management currently believes to be reasonable assumptions, the Company cannot assure prospective investors that actual results, performance or achievements will be consistent with these forward-looking statements. Except as required by law, the Company expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events or otherwise.

Monique L. Delorme

Chief Financial Officer

+1-416-548-7522

[email protected]

KEYWORDS: United States North America Canada

INDUSTRY KEYWORDS: Medical Devices Health Technology Surgery Other Technology Other Health

MEDIA: