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Medtronic Canada Recognized as one of Canada’s Top 100 Employers for 2021

Canada NewsWire

COVID-19 Response, Mission Focus, and a Comprehensive Health and Wellness Package Among Reasons for Selection

BRAMPTON, ON, Nov. 13, 2020 /CNW/ – Medtronic Canada ULC, a subsidiary of Medtronic plc (NYSE: MDT), announced today that it has been recognized by MediaCorp. as one of Canada’s Top 100 Employers for 2021, for the seventh time.


Canada’s Top 100 Employers is a national competition to determine which employers lead their industries in offering exceptional workplaces and the most progressive and forward-thinking programs for their employees.

Throughout this year’s global pandemic, Medtronic has prioritized ongoing communication, mental wellness, and its employees’ health and safety. Since March, 94% of employees have been working from home and relied on ongoing leadership communication to stay connected. The company’s president, Neil Fraser, initially held weekly (now bi-weekly) all-employee calls, which included a prominent public health physician to address the latest COVID-19 related updates and respond to employees’ questions and concerns. “We recognized that throughout all of the noise, employees valued our weekly touchpoints as an occasion to keep connected as a company and to support each other,” said Fraser.

Employees have continued to live the company’s Mission — to alleviate pain, restore health, and extend life.

Nicole Martel, a field service representative, agrees. Martel is on the road four days a week throughout Ontario. She services and repairs Medtronic ventilators — the products that have been at the forefront in the management of some hospitalized COVID-19 patients. Martel supports all of Ontario and when airline flights were cancelled because of the COVID-19 pandemic, she had to drive up to 12 hours to support customers.

The fifth tenet of the company’s Mission — to recognize the personal worth of all employees — is something that resonates with Martel. “Throughout the pandemic, I never felt alone,” added Martel. “Through Neil’s weekly calls, my amazing team, and the health programs that were offered, I received everything I needed to continue to do my job.”

In May 2020, the company added a virtual health care plan that employees could benefit from, including online physician consultations. The company also collaborated with the Canadian Mental Health Association and implemented Not Myself Today® as an additional tool to help support employees’ mental well-being; Medtronic also encourages physical wellness through live online fitness and meditation classes.

Medtronic is the largest medical device employer in Canada and Medtronic technologies are used to address nearly 70 medical conditions. Last year alone, Medtronic innovations benefitted 75 million people globally — that’s two people every second.


About Medtronic Canada ULC

Proudly serving Canadian healthcare for over 50 years, Medtronic Canada ULC (www.medtronic.ca), is a subsidiary of Medtronic plc, one of the world’s largest medical technology, services, and solutions companies — alleviating pain, restoring health, and extending life for millions of people around the world. Serving physicians, hospitals, and patients across the country, Medtronic Canada ULC is headquartered in Brampton, Ontario, with regional offices in Montreal and Vancouver, and a Medtronic Resource Centre in Surrey, BC. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the U.S. Securities and Exchange Commission. Actual results may differ materially from anticipated results.

SOURCE Medtronic Canada ULC

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Thinking about buying stock in Workhorse Group, Nio, Walt Disney, Plug Power, or Cisco Systems?

PR Newswire

NEW YORK, Nov. 13, 2020 /PRNewswire/ — InvestorsObserver issues critical PriceWatch Alerts for WKHS, NIO, DIS, PLUG, and CSCO.

To see how InvestorsObserver’s proprietary scoring system rates these stocks, view the InvestorsObserver’s PriceWatch Alert by selecting the corresponding link.

(Note: You may have to copy this link into your browser then press the [ENTER] key.)

InvestorsObserver’s PriceWatch Alerts are based on our proprietary scoring methodology. Each stock is evaluated based on short-term technical, long-term technical and fundamental factors. Each of those scores is then combined into an overall score that determines a stock’s overall suitability for investment.

Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/thinking-about-buying-stock-in-workhorse-group-nio-walt-disney-plug-power-or-cisco-systems-301172767.html

SOURCE InvestorsObserver

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Heron Therapeutics Resubmits New Drug Application to FDA for HTX-011 for the Treatment of Postoperative Pain

PR Newswire

SAN DIEGO, Nov. 13, 2020 /PRNewswire/ — Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced that the New Drug Application (NDA) was resubmitted to the U.S. Food and Drug Administration (FDA) for HTX-011, an investigational agent for the management of postoperative pain.

The NDA for HTX-011 was resubmitted based on the outcome and final minutes of a Type A End-of-Review meeting with the FDA in September, which was conducted to obtain clarity on the information needed to address the Complete Response Letter (CRL) issued by the FDA in June 2020. The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional non-clinical information. There are four non-clinical issues in the CRL, three relate to confirming exposure of excipients in preclinical reproductive toxicology studies and the fourth relates to changing the manufacturing release specification of the allowable level of an impurity based on animal toxicology coverage. Since receiving the CRL, Heron generated data showing that peak plasma levels (Cmax) of excipients in reproductive toxicology studies are >50- to >200-fold higher than the levels observed in patients receiving the highest dose of HTX-011. These results provide validation of the previously submitted animal studies. At the Type A End-of-Review meeting in September, the FDA agreed with the change to the manufacturing specification proposed by Heron to address their concern. The FDA indicated at the Type A End-of-Review meeting that the submission will be classified as a Class 2 resubmission, which means that the FDA can take up to 6 months to review the new information included in the NDA resubmission.

“We are pleased to have resubmitted the NDA for HTX-011, which we believe fully addresses the CRL based on advice from the FDA,” said Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron. “In our resubmission, we provided compelling evidence responding to the issues identified in the CRL that should provide the basis for the approval of the HTX-011 NDA. Heron remains committed to bringing HTX-011 to patients and we look forward to working with the FDA to achieve this goal.”

About HTX-011 for Postoperative Pain (
ZYNRELEFTM
 in the European Union and European Economic Area)

HTX-011, an investigational non-opioid analgesic, is a dual-acting, fixed-dose combination of the local anesthetic bupivacaine with a low dose of the nonsteroidal anti-inflammatory drug meloxicam. It is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and opioid use through 72 hours compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. The FDA granted Breakthrough Therapy designation to HTX-011 and the NDA received Priority Review designation. A CRL was received from the FDA regarding the NDA for HTX-011 in June 2020 relating to non-clinical information. No clinical safety or efficacy issues and no chemistry, manufacturing and controls issues were identified. Heron’s New Drug Submission (NDS) for HTX-011 for the management of postoperative pain was accepted by Health Canada. Heron is working to respond to a list of questions received from Health Canada in July 2020. In September 2020, the European Commission (EC) granted a marketing authorization for ZYNRELEF (also known as HTX-011) for the treatment of somatic postoperative pain from small- to medium-sized surgical wounds in adults. The EC’s centralized marketing authorization is valid for the 27 countries that are members of the European Union, and the other countries in the European Economic Area.

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs. Heron is developing novel, patient-focused solutions that apply its innovative science and technologies to already-approved pharmacological agents for patients suffering from pain or cancer. For more information, visit www.herontx.com.

Forward-looking Statements

This news release contains “forward-looking statements” as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management’s expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially, including, but not limited to, those associated with: whether the FDA approves the NDA for HTX-011; the timing of the commercial launch of HTX-011 in the U.S.; the timing of the commercial launch of ZYNRELEF in Europe; the timing of Health Canada’s NDS review process for HTX-011; whether Health Canada issues a Notice of Compliance for the NDS for HTX-011; the extent of the impact of the ongoing COVID-19 pandemic on our business; and other risks and uncertainties identified in the Company’s filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations Contact:

David Szekeres

EVP, Chief Operating Officer
Heron Therapeutics, Inc.
[email protected] 
858-251-4447

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SOURCE Heron Therapeutics, Inc.

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Trillium Gold to Acquire Remaining Interest in Gold Bearing Newman Todd Property

PR Newswire

  • On Closing Trillium
     
    will
     
    control
     100
    %
     
    in
     
    the
     198
    hectare
     
    Newman
     
    Todd
     
    Property

VANCOUVER, BC, Nov. 13, 2020 /PRNewswire/ – Trillium Gold Mines Inc. (TSXV: TGM) (OTCQX: TGLDF) (“Trillium” or the “Company”) is pleased to report that the Company has exercised its pre-emptive right to acquire from Heliostar Metals Ltd. (formerly Redstar Gold Corp.) (“Helio“) its 16.5% interest in the Newman Todd Project which will result in the Company holding a 100% interest in the Project. Previously the Company owned 83.5% interest in the 198 hectare Project. The Company has agreed to pay to Helio $700,009.43 in cash and to pay the Earn-Out (described below).

Russell Starr, CEO of Trillium Gold comments “Owning a 100% interest in the Newman Todd structure is a crucial acquisition and consistent with our view of maximizing shareholder value through a growth-oriented precious metals exploration company focused in the Americas. We will soon emerge as the one of largest land holders in the Red Lake Gold Camp having acquired some of the most highly perspective property packages in recent months.”

On September 15, 2020, the Company received a pre-emptive right notice (the “Notice“) from Helio indicating that MTNASH Pty Ltd. (“Nash“) offered to purchase from Helio its 16.5% interest in the Newman Todd Project (the “Nash Offer“) for $700,000 of cash and C$2,000,000 worth or ordinary shares in the capital of Nash (the “Nash Shares“). The Nash Offer also provided for an earn-out payment of $1,000,000 in the event the “measured and indicated reserves and resources” on the Newman Todd Project are 1,000,000 ounces or more (the “Earn-Out“). Pursuant to the terms of the agreement between Helio and the Company in respect of the Newman Todd Project, the Company has a right to match any third party offer for Helio’s interest.

Upon receipt of the Nash Offer, the Company undertook a diligence exercise to confirm the fair market value of the Nash Shares.  The results of the Company’s due diligence resulted in the Company determining the fair market value of the Nash Shares was $10 Australian Dollars (“AUD“) based on the following: (i) Nash was incorporated on September 1, 2020, two weeks before Helio delivered the Notice, (ii) Nash has no Australian Business Number (“ABN“) and accordingly NASH  cannot carry on business and (ii) the entire capital stock of Nash is $10.00 AUD, being the price paid for 10 ordinary shares (the “Shares“) issued to Nash’s sole director, officer and shareholder, Mr. Luke McFarlane.  The Company exercised its pre-emptive right on the basis of its determination of the fair market value of the non-monetary consideration contained in the Nash Offer, and awaits confirmation from Helio that it will honour its obligation to complete the transaction on the terms set out above, failing which the Company will determine its recourse. 

The completion of the purchase and sale is conditional on, among other things, the approval of the TSX Venture Exchange.

The Project hosts the Newman Todd Structure, a narrow structural body that is defined in part by a distinct unconformity. The rocks of the structure are hydrothermally altered and brecciated. Gold mineralization is often associated with the altered breccia zones and occurs as both free gold in quartz veins and in gold-bearing pyrite, pyrrhotite and sphalerite.

The project is located in the high grade gold capital of Canada–  Red Lake, Ontario. Drill programs undertaken in the past, as well as recent results from the 2020 summer program, have shown some exciting high grade gold intersections on the Property, and mineralization remains open along strike and to depth.

The technical information presented in this news release has been reviewed and approved by William Paterson QP, PGeo, VP of Exploration of Trillium Gold Mines, as defined by NI 43-101.

On behalf of the Board of Directors,

Trillium Gold Mines Inc.

“Russell Starr”

Russell Starr

President, CEO and Director

About Trillium Gold Mines Inc.
Trillium Gold Mines Inc. is a British Columbia based company engaged in the business of acquisition, exploration and development of mineral properties located in the highly prospective Red Lake Mining District of Northern Ontario.

Disclosure and Caution

Completion of the transaction is subject to a number of conditions, including TSX Venture Exchange acceptance. The transaction cannot close until the required conditions are satisfied and required approvals are obtained. There can be no assurance that the transaction will be completed as proposed or at all. Trading in the securities of the Company should be considered highly speculative. The TSX Venture Exchange has not reviewed or approved the terms to the Transaction.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release contains forward-looking information, which involves known and unknown risks, uncertainties and other factors that may cause actual events to differ materially from current expectation. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company disclaims any intention or obligation, except to the extent required by law, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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SOURCE Trillium Gold Mines Inc.

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Marriott Vacations Worldwide Corporation to Present at the Barclays Eat, Sleep, Play Conference on December 2, 2020

PR Newswire

ORLANDO, Fla., Nov. 13, 2020 /PRNewswire/ — Marriott Vacations Worldwide Corporation (NYSE: VAC) announced today that John Geller, executive vice president and chief financial and administrative officer, will participate in a fireside chat at the Barclays Eat, Sleep, Play Conference on Wednesday, December 2, 2020 at 1:00 p.m. ET.

A live webcast will be available in the Investor Relations section of the company’s website at ir.mvwc.com. The webcast will also be available on the company’s website for 30 days following the call.


About Marriott Vacations Worldwide Corporation


Marriott Vacations Worldwide Corporation is a leading global vacation company that offers vacation ownership, exchange, rental and resort and property management, along with related businesses, products and services. The company has a diverse portfolio that includes seven vacation ownership brands. It also includes exchange networks and membership programs, as well as management of other resorts and lodging properties. As a leader and innovator in the vacation industry, the company upholds the highest standards of excellence in serving its customers, investors and associates while maintaining exclusive, long-term relationships with Marriott International and Hyatt Hotels Corporation for the development, sales and marketing of vacation ownership products and services. For more information, please visit www.marriottvacationsworldwide.com.

 

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SOURCE Marriott Vacations Worldwide

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Gabelli Utility Trust Continues Monthly Distributions, Declaring Distributions of $0.05 Per Share

Gabelli Utility Trust Continues Monthly Distributions, Declaring Distributions of $0.05 Per Share

RYE, N.Y.–(BUSINESS WIRE)–
The Board of Trustees of The Gabelli Utility Trust (NYSE:GUT) (the “Fund”) approved the continuation of its policy of paying fixed monthly cash distributions. The Board of Trustees declared cash distributions of $0.05 per share for each of January, February, and March 2021.

 

Distribution Month

Record Date

Payable Date

January

January 14, 2021

January 22, 2021

February

February 11, 2021

February 19, 2021

March

March 17, 2021

March 24, 2021

Additionally, the Board of Trustees continues to evaluate potential strategic opportunities for the Fund in what we believe to be an attractive environment to invest in the broader equity markets.

Each quarter, the Board of Trustees reviews the amount of any potential distribution from the income, realized capital gain, or capital available. The Board of Trustees will continue to monitor the Fund’s distribution level, taking into consideration the Fund’s net asset value and the financial market environment. If necessary, the Fund will pay an adjusting distribution in December which includes any additional income and net realized capital gains in excess of the monthly distributions for that year to satisfy the minimum distribution requirements of the Internal Revenue Code for regulated investment companies. The Fund’s distribution policy is subject to modification by the Board of Trustees at any time, and there can be no guarantee that the policy will continue. The distribution rate should not be considered the dividend yield or total return on an investment in the Fund. The Gabelli Utility Trust has paid a distribution to shareholders every month since October 1999.

The Fund’s shares are currently trading at a premium to net asset value. The Board of Trustees believes that the premium at which the Fund shares trade relative to net asset value is not likely to be sustainable. Shareholders participating in the Fund’s dividend reinvestment plan should note that at the current market price, the reinvestment of distributions occurs at a premium to net asset value.

All or part of the distribution may be treated as long-term capital gain or qualified dividend income (or a combination of both) for individuals, each subject to the maximum federal income tax rate for long term capital gains, which is currently 20% in taxable accounts for individuals (or less depending on an individual’s tax bracket). In addition, certain U.S. shareholders who are individuals, estates or trusts and whose income exceeds certain thresholds will be required to pay a 3.8% Medicare surcharge on their “net investment income”, which includes dividends received from the Fund and capital gains from the sale or other disposition of shares of the Fund.

If the Fund does not generate sufficient earnings (dividends and interest income, less expenses, and realized net capital gain) equal to or in excess of the aggregate distributions paid by the Fund in a given year, then the amount distributed in excess of the Fund’s earnings would be deemed a return of capital. Since this would be considered a return of a portion of a shareholder’s original investment, it is generally not taxable and would be treated as a reduction in the shareholder’s cost basis.

Long-term capital gains, qualified dividend income, investment company taxable income, and return of capital, if any, will be allocated on a pro-rata basis to all distributions to common shareholders for the year. Based on the accounting records of the Fund currently available, each of the distributions paid to common shareholders in 2020 would include approximately 1% from net investment income and 99% would be deemed a return of capital on a book basis. The source of the distributions will likely change due to investment activity through the end of the calendar year and this information does not represent what should be reported for tax purposes. The estimated components of each distribution are updated and provided to shareholders of record in a notice accompanying the distribution and are available on our website (www.gabelli.com). The final determination of the sources of all distributions in 2020 will be made after year end and can vary from the monthly estimates. Shareholders should not draw any conclusions about the Fund’s investment performance from the amount of the current distribution. All individual shareholders with taxable accounts will receive written notification regarding the components and tax treatment for all 2020 distributions in early 2021 via Form 1099-DIV.

Investors should carefully consider the investment objectives, risks, charges, and expenses of the Fund before investing. More information regarding the Fund’s distribution policy and other information about the Fund is available by calling 800-GABELLI (800-422-3554) or visiting www.gabelli.com.

About The Gabelli Utility Trust

The Gabelli Utility Trust is a diversified, closed-end management investment company with $328 million in total net assets whose primary investment objective is to seek long-term growth of capital and income by investing primarily in utility companies involved in the generation and distribution of electricity, gas, and water. The Fund is managed by Gabelli Funds, LLC, a subsidiary of GAMCO Investors, Inc. (NYSE:GBL).

NYSE – GUT

CUSIP – 36240A101

Investor Relations:

David Schachter

(914} 921-5057

[email protected]

KEYWORDS: New York United States North America

INDUSTRY KEYWORDS: Banking Professional Services Finance

MEDIA:

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Lineage Cell Therapeutics Proudly Supports Patients’ Access to Innovative Cell Therapy Treatments and Research Through Passage of Proposition 14

Lineage Cell Therapeutics Proudly Supports Patients’ Access to Innovative Cell Therapy Treatments and Research Through Passage of Proposition 14

 Voters Authorize California Institute for Regenerative Medicine to Fund $5.5 Billion in Grants for Stem Cell Research and Development

CARLSBAD, Calif.–(BUSINESS WIRE)–Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX), a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs, strongly endorses the recent passing of Proposition 14 in California. This bill will enhance patients’ access to groundbreaking stem cell therapy treatments by authorizing the California Institute for Regenerative Medicine (CIRM) the ability to fund up to $5.5 billion in grants to support therapeutic development, medical research, and facilities based on stem cell technologies. This initiative builds upon the success of Proposition 71, which issued approximately $3 billion for the funding of stem cell research and led to important medical advances, including functional cures in some patients receiving cell therapy treatments. The development of Lineage’s OPC1 oligodendrocyte progenitor cell therapy for the treatment of acute spinal cord injury (SCI), was one of the first clinical trials supported by CIRM and has showed durable and encouraging results in some patients.

“At Lineage, the patients and their families inspire us to advance cell therapy products and this recent approval of Proposition 14 ensures that access to cutting edge cell-based therapies can continue from companies like ours,” stated Brian M. Culley, Lineage CEO. “Cell therapy has the ability to make a profound impact on millions of lives and the passage of Proposition 14 reflects California’s serious commitment to supporting innovative local companies through the expensive and time-consuming process required to discover and test new cell-based therapies and will drive further innovation in stem cell development and research. Of note, our clinical study of OPC1 for the treatment of acute spinal cord injury was one of the first cell therapy clinical trials supported by CIRM under Prop 71. It was tremendously meaningful for some of our patients’ success stories to be featured in the Prop 14 campaign this year, along with others who have experienced life-changing benefits from stem cell therapy innovation in California. We are extremely thankful to CIRM for their partnership and valuable contributions, not only to Lineage, but also for other companies working in this exciting and rapidly growing field. We believe that all three of our clinical-stage programs could be considered for future grant funding under this new initiative.”

About OPC1

OPC1 is an oligodendrocyte progenitor cell (OPC) transplant therapy designed to provide clinically meaningful improvements to motor recovery in individuals with acute spinal cord injuries (SCI). OPCs are naturally occurring precursors to the cells which provide electrical insulation for nerve axons in the form of a myelin sheath. SCI occurs when the spinal cord is subjected to a severe crush or contusion injury and typically results in severe functional impairment, including limb paralysis, aberrant pain signaling, and loss of bladder control and other body functions. There are approximately 18,000 new spinal cord injuries annually in the U.S. and there currently are no FDA-approved drugs specifically for the treatment of SCI. The OPC1 program has been partially funded by a $14.3 million grant from the California Institute for Regenerative Medicine. OPC1 has received Regenerative Medicine Advanced Therapy (RMAT) designation and Orphan Drug designation from the U.S. Food and Drug Administration (FDA).

About the OPC1 Clinical Study

The SCiStar Study of OPC1 is an open-label, 25-patient, single-arm trial testing three sequential escalating doses of OPC1 which was administered 21 to 42 days post-injury, at up to 20 million OPC1 cells in patients with subacute motor complete (AIS-A or AIS-B) cervical (C-4 to C-7) acute spinal cord injuries (SCI). These individuals had experienced severe paralysis of the upper and lower limbs. The primary endpoint in the SCiStar study was safety as assessed by the frequency and severity of adverse events related to OPC1, the injection procedure, and immunosuppression with short-term, low-dose tacrolimus. Secondary outcome measures included neurological functions measured by upper extremity motor scores (UEMS) and motor level on International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) examinations through 365 days post-treatment. Enrollment is complete in this study; patients will continue to be evaluated on a long-term basis.

About Lineage Cell Therapeutics, Inc.

Lineage Cell Therapeutics is a clinical-stage biotechnology company developing novel cell therapies for unmet medical needs. Lineage’s programs are based on its robust proprietary cell-based therapy platform and associated in-house development and manufacturing capabilities. With this platform Lineage develops and manufactures specialized, terminally differentiated human cells from its pluripotent and progenitor cell starting materials. These differentiated cells are developed to either replace or support cells that are dysfunctional or absent due to degenerative disease or traumatic injury or administered as a means of helping the body mount an effective immune response to cancer. Lineage’s clinical programs are in markets with billion dollar opportunities and include three allogeneic (“off-the-shelf”) product candidates: (i) OpRegen®, a retinal pigment epithelium transplant therapy in Phase 1/2a development for the treatment of dry age-related macular degeneration, a leading cause of blindness in the developed world; (ii) OPC1, an oligodendrocyte progenitor cell therapy in Phase 1/2a development for the treatment of acute spinal cord injuries; and (iii) VAC, an allogeneic dendritic cell therapy platform for immuno-oncology and infectious disease, currently in clinical development for the treatment of non-small cell lung cancer. For more information, please visit www.lineagecell.com or follow the Company on Twitter @LineageCell.

Forward-Looking Statements

Lineage cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” project,” “target,” “tend to,” or the negative version of these words and similar expressions. Such statements include, but are not limited to, statements relating to Lineage’s expected eligibility for grants. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Lineage’s actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by the forward-looking statements in this press release, including risks and uncertainties inherent in Lineage’s business and other risks in Lineage’s filings with the Securities and Exchange Commission (the SEC). Lineage’s forward-looking statements are based upon its current expectations and involve assumptions that may never materialize or may prove to be incorrect. All forward-looking statements are expressly qualified in their entirety by these cautionary statements. Further information regarding these and other risks is included under the heading “Risk Factors” in Lineage’s periodic reports with the SEC, including Lineage’s Annual Report on Form 10-K filed with the SEC on March 12, 2020 and its other reports, which are available from the SEC’s website. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date on which they were made. Lineage undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.

Lineage Cell Therapeutics, Inc. IR

Ioana C. Hone

([email protected])

(442) 287-8963

Solebury Trout IR

Gitanjali Jain Ogawa

([email protected])

(646) 378-2949

Russo Partners – Media Relations

Nic Johnson or David Schull

[email protected]

[email protected]

(212) 845-4242

KEYWORDS: California United States North America

INDUSTRY KEYWORDS: Biotechnology Pharmaceutical Health Clinical Trials

MEDIA:

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Trio-Tech Reports First Quarter Results

Trio-Tech Reports First Quarter Results

VAN NUYS, Calif.–(BUSINESS WIRE)–Trio-Tech International (NYSE MKT: TRT) today announced financial results for the first quarter of fiscal 2021 ended September 30, 2020.

Total revenue for the three months ended September 30, 2020 decreased 30% to $6,841,000. This compares to total revenue of $9,823,000 for the first quarter of fiscal 2020. Revenue in each of the Company’s operating segments — manufacturing, testing services, and distribution — decreased in this year’s first quarter versus the same period of last fiscal year, primarily reflecting the impact of the global Covid-19 pandemic.

Overall gross margin decreased to $1,518,000, or 22% of revenue, compared to $2,252,000, or 23% of revenue, for the first quarter last fiscal year.

Operating expenses for the first quarter of fiscal 2021 decreased 9% to $1,845,000, or 27% of revenue, compared to $2,030,000, or 21% of revenue, for the first quarter of fiscal 2020.

The operating loss for this year’s first quarter was $327,000. This compares to operating income of $222,000 for the same quarter a year ago.

Total other income was $174,000 for the first quarter of fiscal 2021 compared to $42,000 for the same quarter last year. Other income for this year’s first quarter included government assistance of $142,000 for Trio-Tech’s Singapore and Malaysia operations to mitigate the adverse impact on the business from the pandemic. There was no such assistance in the same quarter last year.

The net loss for the first quarter of fiscal 2021 was $8,000, or $0.00 per share. This compares to net income for the first quarter of fiscal 2020 of $273,000, or $0.07 per diluted share.

Shareholders’ equity at September 30, 2020 was $25,538,000, or $6.93 per outstanding share, compared to $25,146,000, or $6.84 per outstanding share, at June 30, 2020. There were approximately 3,685,555 and 3,673,055 common shares outstanding at September 30, 2020 and June 30, 2020, respectively.

CEO Comments

S.W. Yong, Trio-Tech’s CEO, said, “The global Covid-19 pandemic had a dramatic impact on Trio-Tech’s first quarter performance. While we posted a small net loss in this difficult operating environment, our significant accomplishments include improvements in gross margins in the manufacturing and distribution segments and positive cash flow for the quarter. As the pandemic has yet to run its course, we will continue to adjust operating expenses wherever possible to insure Trio-Tech’s future success.”

About Trio‑Tech

Established in 1958, Trio-Tech International is located in Van Nuys, California, with its Principal Executive Office and regional headquarter in Singapore. Trio-Tech International is a diversified business group with interests in semiconductor testing services, manufacturing and distribution of semiconductor testing equipment, and real estate. Our subsidiary locations include Tianjin, Suzhou, Chongqing in China, as well as Kuala Lumpur Malaysia and Bangkok Thailand. Further information about Trio-Tech’s semiconductor products and services can be obtained from the Company’s Web site at www.triotech.com and www.universalfareast.com.

Forward Looking Statements

This press release contains statements that are forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and may contain forward looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and assumptions regarding future activities and results of operations of the Company. In light of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, the following factors, among others, could cause actual results to differ materially from those reflected in any forward looking statements made by or on behalf of the Company: market acceptance of Company products and services; changing business conditions or technologies and volatility in the semiconductor industry, which could affect demand for the Company’s products and services; the impact of competition; problems with technology; product development schedules; delivery schedules; changes in military or commercial testing specifications which could affect the market for the Company’s products and services; difficulties in profitably integrating acquired businesses, if any, into the Company; risks associated with conducting business internationally and especially in Asia, including currency fluctuations and devaluation, currency restrictions, local laws and restrictions and possible social, political and economic instability; changes in U.S. and global financial and equity markets, including market disruptions and significant interest rate fluctuations; public health issues related to the COVID-19 pandemic; and other economic, financial and regulatory factors beyond the Company’s control. Other than statements of historical fact, all statements made in this Quarterly Report are forward looking, including, but not limited to, statements regarding industry prospects, future results of operations or financial position, and statements of our intent, belief and current expectations about our strategic direction, prospective and future financial results and condition. In some cases, you can identify forward looking statements by the use of terminology such as “may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential,” “believes,” “can impact,” “continue,” or the negative thereof or other comparable terminology. Forward looking statements involve risks and uncertainties that are inherently difficult to predict, which could cause actual outcomes and results to differ materially from our expectations, forecasts and assumptions.

TRIO‑TECH INTERNATIONAL AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

UNAUDITED (IN THOUSANDS, EXCEPT EARNINGS PER SHARE)

 

 

 

Three Months Ended

 

September 30,

 

 

 

 

Revenue

2020

 

2019

 

 

 

Manufacturing

$

2,625

 

$

3,317

 

Testing services

 

2,954

 

 

4,390

 

Distribution

 

1,258

 

 

2,099

 

Real estate

 

4

 

 

17

 

 

 

 

 

 

6,841

 

 

9,823

 

Cost of Sales

 

 

Cost of manufactured products sold

 

1,937

 

 

2,555

 

Cost of testing services rendered

 

2,322

 

 

3,191

 

Cost of distribution

 

1,047

 

 

1,807

 

Cost of real estate

 

17

 

 

18

 

 

 

 

 

 

5,323

 

 

7,571

 

 

 

 

Gross Margin

 

1,518

 

 

2,252

 

 

 

 

Operating Expenses:

 

 

General and administrative

 

1,660

 

 

1,788

 

Selling

 

111

 

 

190

 

Research and development

 

75

 

 

76

 

Gain on disposal of property, plant and equipment

 

(1

)

 

(24

)

 

 

 

Total operating expenses

 

1,845

 

 

2,030

 

 

 

 

(Loss) Income from Operations

 

(327

)

 

222

 

 

 

 

Other Income (Expenses)

 

 

Interest expenses

 

(37

)

 

(68

)

Other income, net

 

211

 

 

110

 

 

 

 

Total other income

 

174

 

 

42

 

 

 

 

(Loss) Income from Continuing Operations before Income Taxes

 

(153

)

 

264

 

Income Tax Expense

 

(7

)

 

—

 

 

 

 

(Loss) Income from Continuing Operations before Non-controlling Interest, net of tax

 

(160

)

 

264

 

 

 

 

Loss from discontinued operations, net of tax

 

(6

)

 

(1

)

 

 

 

NET (LOSS) INCOME

 

(166

)

 

263

 

 

 

 

Less: Net loss attributable to the non-controlling interest

 

(158

)

 

(10

)

 

 

 

Net (Loss) Income attributable to Trio-Tech International

 

(8

)

 

273

 

 

 

 

Net (Loss) Income Attributable to Trio-Tech International:

 

 

(Loss) Income from continuing operations, net of tax

 

(5

)

 

274

 

Loss from discontinued operations, net of tax

 

(3

)

 

(1

)

 

 

 

Net (Loss) Income Attributable to Trio-Tech International

$

(8

)

$

273

 

 

 

 

Earnings per share

 

 

Basic earnings per share

$

0.00

 

$

0.07

 

 

 

 

Diluted earnings per share

$

0.00

 

$

0.07

 

 

 

 

Weighted Average Shares Outstanding – Basic

 

3,686

 

 

3,673

 

Weighted Average Shares Outstanding – Diluted

 

3,766

 

 

3,690

 

TRIO‑TECH INTERNATIONAL AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME

UNAUDITED (IN THOUSANDS, EXCEPT EARNINGS PER SHARE)

 

 

 

Three Months Ended

 

September 30,

 

2020

 

 

2019

 

 

 

Comprehensive (Loss) Income Attributable to Trio-Tech International:

 

 

 

 

 

Net (loss) income

$

(166

)

$

263

 

Foreign currency translation, net of tax

 

640

 

 

(563

)

 

 

 

Comprehensive Income (Loss)

 

474

 

 

(300

)

 

 

 

Less: comprehensive (loss) income attributable to non-controlling interests

 

(122

)

 

9

 

 

 

 

Comprehensive Income (Loss) Attributable to Trio-Tech International

$

596

 

$

(309

)

TRIO‑TECH INTERNATIONAL AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT NUMBER OF SHARES)

 

 

 

 

 

 

Sep. 30,

 

 

Jun. 30,

2020

 

 

2020

ASSETS

(Unaudited)

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

Cash and cash equivalents

$

4,849

 

$

4,150

Short-term deposits

 

6,678

 

 

6,697

Trade accounts receivable, net

 

5,745

 

 

5,951

Other receivables

 

905

 

 

998

Inventories, net

 

1,872

 

 

1,922

Prepaid expenses and other current assets

 

417

 

 

482

 

 

 

 

Total current assets

 

20,466

 

 

20,200

 

 

 

 

Deferred tax assets

 

276

 

 

247

Investment properties, net

 

699

 

 

690

Property, plant and equipment, net

 

10,135

 

 

10,310

Operating lease right-of-use assets

 

819

 

 

944

Other assets

 

1,738

 

 

1,609

Restricted term deposits

 

1,695

 

 

1,660

 

 

 

 

Total non-current assets

 

15,362

 

 

15,460

 

 

 

 

TOTAL ASSETS

$

35,828

 

$

35,660

 

 

 

 

LIABILITIES AND SHAREHOLDERS’ EQUITY

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

Lines of credit

$

—

 

$

172

Accounts payable

 

2,024

 

 

2,590

Accrued expenses

 

3,549

 

 

3,005

Income taxes payable

 

360

 

 

344

Current portion of bank loans payable

 

425

 

 

370

Current portion of finance leases

 

224

 

 

231

Current portion of operating leases

 

425

 

 

477

Current portion of PPP loan

 

121

 

 

54

 

 

 

 

Total current liabilities

 

7,128

 

 

7,243

 

 

 

 

Bank loans payable, net of current portion

 

1,956

 

 

1,836

Finance leases, net of current portion

 

394

 

 

435

Operating leases, net of current portion

 

394

 

 

467

Income taxes payable

 

385

 

 

430

PPP loan, net of current portion

 

—

 

 

67

Other non-current liabilities

 

33

 

 

36

 

 

 

 

Total non-current liabilities

 

3,162

 

 

3,271

 

 

 

 

TOTAL LIABILITIES

 

10,290

 

 

10,514

 

 

 

 

 

 

 

 

EQUITY

 

 

 

 

 

 

 

TRIO-TECH INTERNATIONAL’S SHAREHOLDERS’ EQUITY:

 

 

 

Common stock, no par value, 15,000,000 shares authorized; 3,685,555 and 3,673,055 shares

 

 

 

issued and outstanding at September 30, 2020 and June 30, 2020, respectively

 

11,458

 

 

11,424

Paid-in capital

 

3,369

 

 

3,363

Accumulated retained earnings

 

8,028

 

 

8,036

Accumulated other comprehensive gain-translation adjustments

 

1,747

 

 

1,143

 

 

 

 

Total Trio-Tech International shareholders’ equity

 

24,602

 

 

23,966

 

 

 

 

Non-controlling interest

 

936

 

 

1,180

 

 

 

 

TOTAL EQUITY

 

25,538

 

 

25,146

 

 

 

 

TOTAL LIABILITIES AND EQUITY

$

35,828

 

$

35,660

 

Company Contact:

A. Charles Wilson

Chairman

(818) 787-7000

Investor Contact:

Berkman Associates

(310) 927-3108

[email protected]

KEYWORDS: California Singapore United States North America Asia Pacific

INDUSTRY KEYWORDS: Other Manufacturing Technology Semiconductor Public Relations/Investor Relations Oil/Gas Communications Manufacturing Energy Hardware

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The Peck Company Holdings to Participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference

The Peck Company Holdings to Participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference

Virtual Meetings to be Held on Wednesday, November 18

BURLINGTON, Vt.–(BUSINESS WIRE)–
The Peck Company Holdings, Inc. (NASDAQ: PECK) (the “Company” or “Peck”), a leading commercial solar engineering, procurement and construction (EPC) company, today announced that Jeff Peck, Chief Executive Officer, John Sullivan, Chief Financial Officer, and Michael D’Amato, Chief Strategy Officer, will participate at Benchmark Company’s 9th Annual Discovery 1×1 Investor Conference. The virtual event will take place on Wednesday, November 1 8, 2020 with virtual 1×1 investor meetings throughout the day.

To schedule a meeting with management, please contact your Benchmark Company representative or Vince Curatola at [email protected] or [email protected].

About Benchmark Company

Benchmark Company is an institutionally focused research, sales & trading and investment banking firm working to set the benchmark in promoting each client’s success.

For additional information, please visit https://www.benchmarkcompany.com.

About The Peck Company Holdings, Inc.

Headquartered in South Burlington, VT, The Peck Company Holdings, Inc. is a 2nd-generation family business founded in 1972 and rooted in values that align people, purpose, and profitability. Ranked by Solar Power World as one of the leading commercial solar contractors in the Northeastern United States, the Company provides EPC services to solar energy customers for projects ranging in size from several kilowatts for residential properties to multi-megawatt systems for large commercial and utility scale projects. The Company has installed over 125 megawatts worth of solar systems since it started installing solar in 2012 and continues its focus on profitable growth opportunities. Please visit www.peckcompany.com for additional information.

Forward Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Words or phrases such as “may,” “should,” “expects,” “could,” “intends,” “plans,” “anticipates,” “estimates,” “believes,” “forecasts,” “predicts” or other similar expressions are intended to identify forward-looking statements, which include, without limitation, earnings forecasts, effective tax rate, statements relating to our business strategy and statements of expectations, beliefs, future plans and strategies and anticipated developments concerning our industry, business, operations and financial performance and condition.

The forward-looking statements included in this press release are based on our current expectations, projections, estimates and assumptions. These statements are only predictions, not guarantees. Such forward-looking statements are subject to numerous risks and uncertainties that are difficult to predict. These risks and uncertainties may cause actual results to differ materially from what is forecast in such forward-looking statements, and include, without limitation, the risk factors described from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K.

All forward-looking statements included in this press release are based on information currently available to us, and we assume no obligation to update any forward-looking statement except as may be required by law.

Michael d’Amato

[email protected]

p802-264-2040

ClearThink

[email protected]

KEYWORDS: United States North America Vermont

INDUSTRY KEYWORDS: Alternative Energy Energy Environment Other Energy Utilities

MEDIA:

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New Data Build on Growing Evidence Supporting TEPEZZA® (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration

New Data Build on Growing Evidence Supporting TEPEZZA® (teprotumumab-trbw) Efficacy in Thyroid Eye Disease (TED), Including in Patients With Less Severe Disease and Longer Disease Duration

— Presentation during American Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual) demonstrates clinical improvement in the less severe eye —

— Additional data from OPTIC 48-week follow-up study and OPTIC-X extension trial, including findings showing that the majority of TEPEZZA patients who were diplopia (double vision) responders in OPTIC at week 24 maintained their response at week 72, nearly a year off-treatment —

— Patients who received placebo during the OPTIC Phase 3 clinical trial and then received TEPEZZA in the OPTIC-X extension trial also achieved clinically significant diplopia improvement with an average of 12 months of disease, compared with six months in OPTIC —

DUBLIN–(BUSINESS WIRE)–
Horizon Therapeutics plc (Nasdaq: HZNP) today announced new TEPEZZA® (teprotumumab-trbw) data presented at the American Academy of Ophthalmology Annual Meeting (AAO 2020 Virtual), including findings suggesting benefits of TEPEZZA in the less severe eye of patients with Thyroid Eye Disease (TED), and new data from theOPTIC 48-week follow-up study and OPTIC-X clinical trial. TEPEZZA is the first and only medicine approved by the U.S. Food and Drug Administration (FDA) for the treatment of TED – a serious, progressive and vision-threatening rare autoimmune disease.1

“We continue to analyze our existing clinical trials and pursue new research to fully understand the impact TEPEZZA has on this challenging disease,” said Elizabeth H.Z. Thompson, Ph.D., group vice president, development and external search, Horizon. “Our data demonstrating the effect of TEPEZZA at varying stages of the disease, including in the less severely affected eye and in patients who have had Thyroid Eye Disease for a longer period of time, will help advance the science of Thyroid Eye Disease and instill greater understanding of the role TEPEZZA can play in improving patient outcomes.”

Compelling Response in Less Severe TED

Improvement in Fellow Eye of Patients with TED: Pooled Analyses from Teprotumumab Studies (PO305)

In patients with TED, one eye can have more severe symptoms than the other. The TEPEZZA Phase 2 clinical trial and OPTIC Phase 3 confirmatory clinical trial designated the more severely affected eye as the “study eye”.2,3 This new analysis focused specifically on efficacy of TEPEZZA in treating the less severe eye, or “fellow eye”, of patients in the TEPEZZA Phase 2 and 3 trials. Researchers analyzed the intent-to-treat (ITT) population in the Phase 2 and Phase 3 studies, defined as all patients randomized to receive TEPEZZA (n=84) and all patients randomized to receive placebo (n=87). The fellow eye was less proptotic than the study eye in both the TEPEZZA (21.61 mm vs. 23.02 mm) and placebo (21.97 mm vs. 23.15 mm) groups, indicating less severe disease. Additionally, the fellow eye, on average, demonstrated less inflammation based on the clinical activity score (CAS) than the study eye in both the TEPEZZA (CAS: 4.3 vs. 5.1 points) and placebo (CAS: 4.7 vs. 5.3 points) groups.

Findings suggest that TEPEZZA may offer benefits in patients with less severe TED:

  • At Week 24, more TEPEZZA patients were proptosis (eye bulging) responders (≥2 mm reduction) in the fellow eye than placebo patients (63.1 percent vs. 8.0 percent, p<0.001), with a mean reduction in proptosis of 2.39 mm for TEPEZZA patients and a mean increase in proptosis of 0.15 mm for placebo patients (p<0.001).
  • 30 patients (34.5 percent) in the placebo group had a worsening of proptosis at Week 24 in the fellow eye compared to 0 patients (0 percent) in the TEPEZZA group.
  • CAS in the fellow eye decreased from baseline by a mean of -3.42 points in the TEPEZZA group compared to -2.00 points in the placebo group (p<0.001) at Week 24.
  • More TEPEZZA patients (63.1 percent) than placebo patients (26.4 percent) had a CAS of 0 or 1 – signifying disease inactivation – in the fellow eye at Week 24 (p<0.001).

“We know from the clinical development program that TEPEZZA significantly reduces proptosis and Thyroid Eye Disease-related inflammation in patients with moderate-to-severe disease, and now with this new analysis of the Phase 2 and 3 data, we have evidence pointing to efficacy in patients with less severe disease as well,” said Raymond Douglas, M.D., Ph.D., study author and director of the Orbital and Thyroid Eye Disease Program, Cedars-Sinai Medical Center. “We believe this robust effect is the result of the mechanism of TEPEZZA that effectively targets the underlying molecular pathways that cause Thyroid Eye Disease.”

Additional Findings from the OPTIC 48-Week Follow-Up Study and OPTIC-X Clinical Trial

Long Term Assessment of Proptosis and Diplopia from the OPTIC Trial of Teprotumumab in Thyroid Eye Disease (PA038)

Additional data from the OPTIC Phase 3 confirmatory clinical trial and the OPTIC-X open-label extension clinical trial were also included in an abstract and presented during AAO, supplementing the topline results on proptosis response announced in July 2020. The OPTIC trial included a 24-week treatment period (treatment every three weeks for a total of eight infusions) and a 48-week off-treatment follow-up period. OPTIC-X evaluated TEPEZZA in patients who were enrolled in OPTIC and were either proptosis non-responders at Week 24 or were proptosis responders at Week 24 but flared during the 48-week off-treatment follow-up period.

New OPTIC 48-week off-treatment follow-up study findings include the following:

  • The majority of TEPEZZA patients who had at least 1 grade of diplopia (double vision) improvement at Week 24 in OPTIC maintained their response at Week 72 (11/19; 58 percent) without receiving additional TED treatment.
  • 50 percent of TEPEZZA patients (8/16) who had a diplopia score of 0 at Week 24 in OPTIC maintained a diplopia score of 0 at Week 72 without receiving additional TED treatment.

New OPTIC-X findings include the following:

  • 61 percent of patients (14/23) who received placebo during the OPTIC trial and then entered OPTIC-X and received TEPEZZA were considered diplopia responders (≥1 grade improvement) at Week 24. This is consistent with results from the OPTIC trial, where 68 percent of patients (19/28) who received TEPEZZA had a change from baseline of at least 1 grade in diplopia at Week 24. OPTIC-X patients had an average of 12 months of TED compared with six months in OPTIC.
  • Five patients who received placebo during the OPTIC trial and then entered OPTIC-X had a CAS of 0 or 1, which means they had minimal or no inflammation. Of those, 60 percent (3/5) were proptosis responders at Week 24 (≥2 mm improvement in proptosis from baseline in the study eye without deterioration in the fellow eye at Week 24).

There were no new safety concerns in OPTIC-X or the OPTIC 48-week off-treatment follow-up period, including in patients who received additional TEPEZZA treatment.

About Thyroid Eye Disease (TED)

TED is a serious, progressive and vision-threatening rare autoimmune disease.1 TED often occurs in people living with hyperthyroidism or Graves’ disease; however, it is a distinct disease that is caused by autoantibodies activating an IGF-1R-mediated signaling complex on cells within the retro-orbital space.4,5 This leads to a cascade of negative effects, which may cause long-term, irreversible damage. As TED progresses, the serious damage it can cause includes proptosis (eye bulging), strabismus (misalignment of the eyes) and diplopia (double vision) – and in some cases can lead to blindness.6,7

About TEPEZZA

INDICATION

TEPEZZA is indicated for the treatment of Thyroid Eye Disease.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Infusion Reactions: TEPEZZA may cause infusion reactions. Infusion reactions have been reported in approximately 4% of patients treated with TEPEZZA. Reported infusion reactions have usually been mild or moderate in severity. Signs and symptoms may include transient increases in blood pressure, feeling hot, tachycardia, dyspnea, headache and muscular pain. Infusion reactions may occur during an infusion or within 1.5 hours after an infusion. In patients who experience an infusion reaction, consideration should be given to premedicating with an antihistamine, antipyretic, or corticosteroid and/or administering all subsequent infusions at a slower infusion rate.

Preexisting Inflammatory Bowel Disease: TEPEZZA may cause an exacerbation of preexisting inflammatory bowel disease (IBD). Monitor patients with IBD for flare of disease. If IBD exacerbation is suspected, consider discontinuation of TEPEZZA.

Hyperglycemia: Increased blood glucose or hyperglycemia may occur in patients treated with TEPEZZA. In clinical trials, 10% of patients (two-thirds of whom had preexisting diabetes or impaired glucose tolerance) experienced hyperglycemia. Hyperglycemic events should be managed with medications for glycemic control, if necessary. Monitor patients for elevated blood glucose and symptoms of hyperglycemia while on treatment with TEPEZZA. Patients with preexisting diabetes should be under appropriate glycemic control before receiving TEPEZZA.

Adverse Reactions

The most common adverse reactions (incidence ≥5% and greater than placebo) are muscle spasm, nausea, alopecia, diarrhea, fatigue, hyperglycemia, hearing impairment, dysgeusia, headache and dry skin.

For additional information on TEPEZZA, please see Full Prescribing Information at TEPEZZAhcp.com.

About Horizon

Horizon is focused on researching, developing and commercializing medicines that address critical needs for people impacted by rare and rheumatic diseases. Our pipeline is purposeful: we apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, please visit www.horizontherapeutics.com and follow us on Twitter, LinkedIn, Instagram and Facebook.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the potential benefits of TEPEZZA as a treatment of less severe TED. These forward-looking statements are based on management expectations and assumptions as of the date of this press release, and actual results may differ materially from those in these forward-looking statements as a result of various factors. These factors include risks associated with future clinical development, whether TEPEZZA will be adopted as a treatment for less severe TED, as well as those described in Horizon’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and Horizon does not undertake any obligation to update or revise these statements, except as may be required by law.

References

  1. Barrio-Barrio J, et al. Graves’ Ophthalmopathy: VISA versus EUGOGO Classification, Assessment, and Management. Journal of Ophthalmopathy. 2015;2015:1-16.
  2. Smith, et al. Teprotumumab for Thyroid-Associated Ophthalmology. N Engl J Med. 2017;376:1748-1761.
  3. Douglas, et al. Teprotumumab for the Treatment of Active Thyroid Eye Disease. N Engl J Med. 2020;382(4):341-352.
  4. Weightman DR, et al. Autoantibodies to IGF-1 Binding Sites in Thyroid Associated Ophthalmopathy. Autoimmunity. 1993;16(4):251–257.
  5. Pritchard J, et al. Immunoglobulin Activation of T Cell Chemoattractant Expression in Fibroblasts from Patients with Graves’ Disease Is Mediated Through the Insulin-Like Growth Factor 1 Receptor Pathway. J Immunol. 2003;170:6348-6354.
  6. Ross DS, et al. The 2016 European Thyroid Association/European Group on Graves’ Orbitopathy Guidelines for the Management of Graves’ Orbitopathy. Eur Thyroid J. 2016;5(1):9-26.
  7. McKeag D, et al. Clinical features of dysthyroid optic neuropathy: a European Group on Graves’ Orbitopathy (EUGOGO ) survey. Br J Ophthalmol. 2007;91:455-458.

Tina Ventura

Senior Vice President, Investor Relations

[email protected]

Ruth Venning

Executive Director, Investor Relations

[email protected]

U.S. Media Contacts:

Rachel Vann

Director, Product Communications

[email protected]

Ireland Media Contact:

Gordon MRM

Ray Gordon

[email protected]

KEYWORDS: California Europe Ireland United States North America

INDUSTRY KEYWORDS: Science Biotechnology Research Pharmaceutical Optical Health Hospitals Genetics

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