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Penske Automotive Provides Operational Update

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BLOOMFIELD HILLS, Mich., July 16, 2020 /PRNewswire/ — Penske Automotive Group, Inc., (NYSE:PAG) a diversified international transportation services company, today provided an operational update on its business for the second quarter of 2020.  Based on the performance of its U.S. and U.K. retail automotive dealerships and its used vehicle supercenter operations in June, coupled with continued expense management across all of our business lines, the Company expects to report earnings per share from continuing operations of $0.52 to $0.57 for the three months ended June 30, 2020.

“I am encouraged by the significant improvement in our operations during the month of June,” said Roger S. Penske, CEO.  “Our performance in June is the result of a strong operational focus to control costs, manage vehicle inventory, and maximize gross profit.”

In the U.S., all retail automotive dealerships are open.  New and used unit sales improved sequentially from May to June and our focus on maximizing vehicle gross profit and managing selling, general and administrative expenses drove the performance in the month.  In the U.K., all dealerships closed on March 24th in accordance with government order.  Service and parts operations resumed during the middle of May, while most of our dealership showrooms re-opened on June 1, 2020.  Since re-opening, sales of new and used vehicles, vehicle grosses and service operations have been strong, with new vehicle unit sales for our business significantly outperforming the overall market in June.

The U.S. and U.K. used vehicle supercenters also reopened in June.  Sales of used units were strong with combined U.S. and U.K. operations generating profit from operations that more than doubled when compared to June of last year.

The Company ended June 2020 with a strong liquidity position of nearly $1.2 billion of cash and availability under its credit facilities.  The Company will repay the $300 million in senior subordinated notes, maturing August 15, 2020, with availability under its U.S. credit agreement, which was undrawn at June 30, 2020.  Further, assuming this $300 million were to remain outstanding under our credit agreement, the Company would realize a benefit of approximately $6 million in annual interest expense savings.

In May 2020, the Company announced the suspension of its cash dividend.  The suspension of the cash dividend will continue and be reevaluated in the future.

Penske Automotive Group expects to release its financial results for the three and six months ended June 30, 2020 and 2019, before the market opens on July 29, 2020.

About Penske Automotive
Penske Automotive Group, Inc., (NYSE: PAG) headquartered in Bloomfield Hills, Michigan, is an international transportation services company that operates automotive and commercial truck dealerships principally in the United States, the United Kingdom, Canada, and Western Europe, and distributes commercial vehicles, diesel engines, gas engines, power systems and related parts and services principally in Australia and New Zealand. PAG is a member of the Fortune 500 and Russell 1000 indexes and is ranked among the World’s Most Admired Companies by Fortune Magazine. For additional information, visit the company’s website at www.penskeautomotive.com.

Caution Concerning Forward Looking Statements
Statements in this press release may involve forward-looking statements, including forward-looking statements regarding Penske Automotive Group, Inc.’s, preliminary estimates of its financial results, its liquidity and assessment of business conditions in light of the COVID-19 pandemic. Actual results may vary materially because of risks and uncertainties that are difficult to predict. These risks and uncertainties include, among others: our financial closing procedures for the three months ended June 30, 2020, which may cause final results upon completion of our closing procedures to vary from the preliminary estimates, which were prepared by the Company’s management, based upon a number of assumptions and additional items that could require material adjustments to the preliminary financial information; the duration, severity and resolution of the COVID-19 pandemic, economic conditions generally, conditions in the credit markets, changes in interest rates and foreign currency exchange rates, changes in tariff rates, adverse impacts related to the outcome of the United Kingdom’s departure from the European Union, adverse conditions affecting a particular manufacturer, including the adverse impact to the vehicle and parts supply chain due to limited vehicle availability due to the COVID-19 pandemic, WLTP and RDE, natural disasters, recall or other disruptions that interrupt the supply of vehicles or parts to us, changes in consumer credit availability, the outcome of legal and administrative matters, and other factors over which management has limited control. These forward-looking statements should be evaluated together with additional information about Penske Automotive Group’s business, markets, conditions and other uncertainties, which could affect Penske Automotive Group’s future performance. These risks and uncertainties are addressed in Penske Automotive Group’s Form 10-K for the year ended December 31, 2019 and its other filings with the Securities and Exchange Commission (“SEC”). This press release speaks only as of its date, and Penske Automotive Group disclaims any duty to update the information herein.

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SOURCE Penske Automotive Group, Inc.

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Press Release

Qingdao Conson Hosts Urban Economy High-Quality Development Forum and Hai Tian Center Launch Ceremony to Accelerate the City's Growth

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UEFA EURO 2020 Sponsor Hisense Showcases Hisense U7 TV at the Tournament

QINGDAO, China, June 21, 2021 /PRNewswire/ — Themed “Building and Sharing a Win-Win Future”, the Urban Economy High-Quality Development Forum & Hai Tian Center Launch Ceremony was hosted by Qingdao Conson Development (Group) at Hai Tian Center in Qingdao on June 20.

 

Qingdao Conson Hosts Urban Economy High-Quality Development Forum and Hai Tian Center Launch Ceremony to Accelerate the City's Growth

With a height of 369 meters (1210.63 ft), Hai Tian Center is home to super-grade A offices, the five-star Haitian Hotel, the St. Regis Qingdao, the Cloud Art Center, an observation deck, the Cloud Diamond Club, the Haitian Mall and Haitian Mansion. As a new landmark, Hai Tian Center will serve as a state-of-the-art locale and venue of choice for meetings and conferences that enhance the city’s service capabilities and influences how the city evolves.

“Conson Group will fully deploy the potential value of Hai Tian Center in attracting investment, stimulating domestic demand, upgrading consumption, and developing a headquarters economy. The Center provides access to a high-quality living space and lifestyle experience for the local populace while becoming a new force to further enhance the vitality, lead next-stage development and redefine the personality of the city of Qingdao,” said Wang Jianhui, Secretary of Party Committee and Chairman of Qingdao Conson Development (Group).

He views the Hai Tian Center as a culmination of all the city has aspired to, a meaningful addition to the city’s legacy and venue par excellence for important meetings and events, while driving the transformation of Qingdao into an open, modern, dynamic and fashionable international metropolis.

Government leaders and officials of Qingdao present at the event commented that, major projects such as Hai Tian Center are breakthrough events that speed up the transition from old to new economic engines. The trouble-free construction and smooth operation of the center bodes well for it to serve as a facilitator of the city’s high-quality economic and social development while enhancing the region’s overall competitiveness.

Long Yongtu, former vice minister of China’s Ministry of Foreign Trade and Economic Cooperation and co-chairman of the Sino-International Entrepreneurs Federation (SIEF), noted: “China is accelerating the construction of a new development pattern with domestic circulation as the mainstay along with the mutual promotion of dual circulation. Against this backdrop, quality and openness are the key to urban economic development.” He spoke highly of Qingdao’s active role in promoting the high-quality development of the city driven by the super-high-rise urban complex such as Hai Tian Center. “I hope that Hai Tian Center can be developed into a center for talents, the service economy, and investments, which can assist Qingdao in its transformation into an open, modern and dynamic international metropolis.”

Looking ahead, Hai Tian Center plans to integrate its competitive resources to facilitate collaboration among businesses and organizations in and around Qingdao with the goal of establishing a modern business ecosystem encompassing information service providers, manufacturers, financial service providers, training and educational institutions and technology firms.

Media contact:

Mr. Gu

+86-158-5328-5676

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The Pressing Need for Early Detection of Mucormycosis during COVID-19

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Fapon Biotech calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

DONGGUAN, China, June 21, 2021 /PRNewswire/ — Mucormycosis or black fungus, a devastating infection that soars in India during COVID-19 has seized global attention. Recently, the country’s mucormycosis cases reached over 57,150 and resulted in 54% mortality. Apart from the association with high diabetes prevalence in India, COVID-19 infected countries (Pakistan, Russia, Nepal, Chile, Brazil, etc.) have also described the same issue, areas with high diabetes and COVID-19 infection rates should be alarmed.

Fapon Biotech calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

Unfortunately, mucormycosis is always being diagnosed late with prolonged COVID-19 healthcare burdens that deteriorate the situation. As a company making continuous research and contribution to the world’s major infectious diseases with the mission to Enable Disease Identification Earlier, More Accurate, Convenient and Affordable, Fapon Biotech Inc. (Fapon Biotech) calls for cooperation with academic and industry partners in developing mucormycosis diagnostic tests to ease the challenge by sharing the abilities of upstream raw material development platforms and downstream reagent application platforms.

Fapon Biotech is one of the mainstream COVID-19 reagent raw material suppliers with proven experiences helping partners to launch accredited COVID-19 reagents in a short time. The company has over 1000 IVD partners worldwide with more than 10 years of business operation in India. Its technology platforms can match the R&D process from partners easily and provide supports from biomarker discovery to commercialization. Through different application platforms of Fapon Biotech (Colloidal Gold/Immunofluorescence/ELISA/CLIA/Latex-Enhanced Immunoturbidimetry/PCR/etc.), biomarkers can quickly complete the process of application development. For partners encountering production challenges, OEM and contract manufacturing services with the capacity reaching hundreds of grams of each batch are available. Because of a strong relationship with laboratories and IVD manufacturers in India, cooperating with Fapon Biotech will have the access to more resources and commercial opportunities, such as clinical samples for research and product validation, technology iterations, product launch and promotion, etc.

As the virus continues its mutation and triggers diseases like mucormycosis to complicate the situation, rapid responses via global cooperation will be crucial for areas with overwhelmed healthcare burdens. Fapon Biotech is committed to fueling the advancement of COVID-19 diagnosis through collaborations with international IVD partners.

About Fapon Biotech

Fapon Biotech was founded in 2001. Guided by the mission of “Enable Disease Identification Earlier, More Accurate, Convenient and Affordable,” the company focuses on the future needs of biotechnology developments and provides global diagnostic companies with high-performance IVD reagent raw materials, such as antigens, antibodies, and enzymes, as well as one-stop solutions with instrument and reagent services.

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RedHill Biopharma Announces Presentation of Positive Oral Opaganib Phase 2 Data in COVID-19

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RedHill Biopharma logo

Positive U.S. Phase 2 safety and efficacy data for opaganib, a leading novel, oral, dual-mechanism drug candidate for moderate-to-severe COVID-19, presented at the World Microbe Forum

Opaganib was associated with a reduction in the need for supplemental oxygen support, earlier time to discharge from hospital and was well tolerated

Opaganib’s global 475-patient Phase 2/3 study is fully enrolled, with study completion expected in the coming weeks

Opaganib is host-targeted and expected to be effective against emerging viral variants

TEL AVIV, Israel and RALEIGH, NC, June 21, 2021 /PRNewswire/ — RedHill Biopharma Ltd. (Nasdaq: RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced presentation of the positive Phase 2 safety and efficacy data for oral opaganib (Yeliva®, ABC294640)[1] in hospitalized patients with COVID-19 pneumonia at the World Microbe Forum (WMF) 2021 (poster #: 5574).

RedHill Biopharma logo

Results and post hoc analyses of data from the 40-patient U.S. Phase 2 study were presented in a poster entitled, “Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618)“[2]. Patients in the study were randomized to receive either opaganib or placebo in addition to standard of care (SoC), predominantly including dexamethasone and/or remdesivir. Findings include:

  • 50% of patients treated with opaganib (n=22) reached room air by Day 14 compared to 22% in the placebo group (n=18). The benefit of reaching room air by Day 14 for patients on opaganib was maintained regardless of whether the patients were receiving dexamethasone and/or remdesivir
  • 86.4% of patients treated with opaganib were discharged from hospital by Day 14 compared to 55.6% of patients treated with placebo
  • Median time to discharge was 6 days for the opaganib group compared to 7.5 days for the placebo group
  • 81.8% of opaganib patients achieved a 2-point improvement in the WHO Ordinal Scale compared to 55.6% of patients in the placebo group – achieved in a median time of 6 days versus 7.5 days, respectively
  • No significant differences in safety-related measures between the two groups (with diarrhea being the main treatment-emergent difference in tolerability)

“The need for an effective oral therapy to treat COVID-19 is clear. Such a therapy would greatly improve our ability to manage this pandemic,” said Kevin Winthrop, MD, MPH, Professor of Infectious Diseases at Oregon Health & Science University, who presented the findings at WMF. “These data, from this proof-of-concept clinical study of opaganib in patients with severe COVID-19, suggest a potential role of SK2 inhibition in combating the effects of this virus. With much more data on opaganib expected in the coming weeks, we could make some real progress toward having access to a much-needed oral therapy for patients who currently have a paucity of options available to them.”

“Presentation of these positive data from our exploratory Phase 2 study support our growing confidence that opaganib could be the first novel, oral therapy to demonstrate efficacy in the treatment of COVID-19 in a large late-stage study. With the recent completion of enrollment of our 475-patient global Phase 2/3 study, we will have a clearer picture of that in the very near future,” said Mark L. Levitt, MD, Ph.D., Medical Director at RedHill. “Opaganib acts on both the cause and effect of COVID-19 via a unique dual antiviral and anti-inflammatory mode of action. Being host-targeted, opaganib is also expected to maintain effect against the emerging SARS-CoV-2 variants, which continue to threaten the progress being made against the pandemic and underscore the urgent need for effective COVID-19 therapeutics.”

The global 475-patient Phase 2/3 study of opaganib in severe COVID-19 has been approved in 10 countries and completed enrollment, through 57 participating sites, on June 6th. The primary endpoint of the study is the proportion of patients breathing room air without oxygen support by Day 14. Additional important outcome measures, such as time to discharge from hospital, improvement according to the World Health Organization Ordinal Scale for Clinical Improvement and incidence of intubation and mortality, will also be captured in the follow-up period of up to 6 weeks. The study received four independent DSMB recommendations to continue following unblinded safety reviews and a futility review. Additionally, an evaluation of the blinded blended intubation and mortality rates to date was encouraging as compared to reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations[3].

About Opaganib (Yeliva®, ABC294640)

Opaganib, a new chemical entity, is a proprietary, first-in-class, orally-administered, sphingosine kinase-2 (SK2) selective inhibitor, with dual anti-inflammatory and antiviral activity, that is host-targeted and is therefore expected to be effective against emerging viral variants. Opaganib has also shown anticancer activity and has the potential to target multiple oncology, viral, inflammatory, and gastrointestinal indications.

Opaganib is being evaluated as a treatment for COVID-19 pneumonia in a global Phase 2/3 study, which recently completed enrollment, and has demonstrated positive safety and efficacy signals in preliminary top-line data from the 40-patient U.S. Phase 2 study.

Opaganib has also received Orphan Drug designation from the U.S. FDA for the treatment of cholangiocarcinoma and is being evaluated in a Phase 2a study in advanced cholangiocarcinoma and in a Phase 2 study in prostate cancer.

Opaganib demonstrated potent antiviral activity against SARS-CoV-2, the virus that causes COVID-19, completely inhibiting viral replication in an in vitro model of human lung bronchial tissue. Additionally, preclinical in vivo studies have demonstrated opaganib’s potential to ameliorate inflammatory lung disorders, such as pneumonia, and has shown decreased fatality rates from influenza virus infection and ameliorated Pseudomonas aeruginosa-induced lung injury by reducing the levels of IL-6 and TNF-alpha in bronchoalveolar lavage fluids[4].

The ongoing studies with opaganib are registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health, which provides public access to information on publicly and privately supported clinical studies.   

About RedHill Biopharma    

RedHill Biopharma Ltd. (Nasdaq: RDHL) is a specialty biopharmaceutical company primarily focused on gastrointestinal and infectious diseases. RedHill promotes the gastrointestinal drugs, Movantik® for opioid-induced constipation in adults[5], Talicia® for the treatment of Helicobacter pylori (H. pylori) infection in adults[6], and Aemcolo® for the treatment of travelers’ diarrhea in adults[7]. RedHill’s key clinical late-stage development programs include: (i) RHB-204, with an ongoing Phase 3 study for pulmonary nontuberculous mycobacteria (NTM) disease; (ii) opaganib (Yeliva®, ABC294640), a firstinclass SK2 selective inhibitor targeting multiple indications with positive Phase 2 COVID-19 data and an ongoing Phase 2/3 program for COVID-19 and Phase 2 studies for prostate cancer and cholangiocarcinoma ongoing; (iii) RHB-107 (upamostat), a serine protease inhibitor in a U.S. Phase 2/3 study as treatment for symptomatic COVID-19, and targeting multiple other cancer and inflammatory gastrointestinal diseases; (iv) RHB-104, with positive results from a first Phase 3 study for Crohn’s disease; (v) RHB-102 (Bekinda®), with positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D; and (vi) RHB106, an encapsulated bowel preparation. More information about the Company is available at www.redhillbio.com / https://twitter.com/RedHillBio.         

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include the delay in last patient visit and top-line data from the Phase 2/3 COVID-19 study for opaganib, that the Phase 2/3 COVID-19 study for opaganib may not be successful and, even if successful, such study and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional COVID-19 studies for opaganib are likely to be required by regulatory authorities to support such potential applications and the use or marketing of opaganib for COVID-19 patients, that opaganib will not be effective against emerging viral variants, as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, preclinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its preclinical studies or clinical trials (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Movantik®, Talicia® and Aemcolo®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company’s ability to acquire products approved for marketing in the U.S. that achieve commercial success and build and sustain its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company’s therapeutic candidates and the results obtained with its therapeutic candidates in research, preclinical studies or clinical trials; (ix) the implementation of the Company’s business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and commercial products and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company’s expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse events using investigative drugs under the Company’s Expanded Access Program; and (xiv) competition from other companies and technologies within the Company’s industry. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 20-F filed with the SEC on March 18, 2021. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law.

 

Company contact:

Adi Frish

Chief Corporate & Business Development Officer

RedHill Biopharma

+972-54-6543-112

adi@redhillbio.com

Media contacts:

U.S.: Bryan Gibbs, Finn Partners

+1 212 529 2236

bryan.gibbs@finnpartners.com

UK: Amber Fennell, Consilium

+44 (0) 7739 658 783  

fennell@consilium-comms.com

 

[1] Opaganib is an investigational new drug, not available for commercial distribution.

[2] Opaganib, an Oral Sphingosine Kinase-2 (SK2) Inhibitor in COVID-19 Pneumonia: A Randomized, Double-blind, Placebo-controlled Phase 2A Study, in Adult Subjects Hospitalized with SARS-CoV-2 Positive Pneumonia (NCT: 04414618). K. L. Winthrop, A. W. Skolnick, A. M. Rafiq, S. H. Beegle, J. Suszanski, G. Koehne, O.Barnett-Griness, A. Bibliowicz, R. Fathi, P. Anderson, G. Raday, G. Eagle, V. Katz Ben-Yair, H. S. Minkowitz, M. L. Levitt, M. S. Gordon

[3] Based on preliminary blinded blended data from 463 patients. The Company did not conduct a head-to-head comparison study in the same patient population. The theoretical comparison between the global Phase 2/3 study with opaganib and reported rates of mortality from large platform studies such as RECOVERY, and other studies in similar patient populations, serves as a general benchmark and should not be construed as a direct and/or applicable comparison as if the Company conducted a head-to-head comparison study.

[4] Xia C. et al. Transient inhibition of sphingosine kinases confers protection to influenza A virus infected mice. Antiviral Res. 2018 Oct; 158:171-177. Ebenezer DL et al. Pseudomonas aeruginosa stimulates nuclear sphingosine-1-phosphate generation and epigenetic regulation of lung inflammatory injury. Thorax. 2019 Jun;74(6):579-591.

[5] Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.  

[6] Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.       

[7] Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.

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