1847 Goedeker Announces Third Quarter 2020 Results

1847 Goedeker Announces Third Quarter 2020 Results

  • Nine Month Cash Flow from Operations Increased to $7.4M vs $(0.6M) for Same Period Prior Year
  • Q2 Revenue Up 10.1% Year-Over-Year to $13.4M
  • Written Orders Up 143% Year-Over-Year to $36.9M
  • Company to host conference call at 4:15 p.m. ET today

 

BALLWIN, Mo.–(BUSINESS WIRE)–
1847 Goedeker Inc. (NYSE American: GOED) (“Goedeker’s” or the “Company”), a one-stop e-commerce destination for appliances, furniture, home goods, and related products, today reported financial results for its third quarter ended September 30, 2020.

Business Highlights:

  • Site sessions increased 80% to 2.7 million in the third quarter of 2020, up from 1.5 million in the prior year period.
  • Written orders in the quarter ended September 30, 2020, reached $36.9 million, up 143% from $15.2 million in the prior year period.
  • Shipped orders increased to $13.4 million in the third quarter of 2020, up 10.1% from $12.2 million in the prior year period.
  • Completed IPO on NYSE American on August 4, 2020; raised net proceeds of approximately $9 million.
  • Art Smuck, former CEO of FedEx Supply Chain, joined Goedeker’s as Senior Strategic Advisor for Logistics to support accelerated growth plans.
  • Reduced annual debt service by $410,000 through 3.25% loan refinancing.
  • Expanded customer financing options with multiple new third-party offerings with no credit risk or balance sheet impact to the Company.
  • Appointed new VP of Logistics, Jacob Guilhas, to accelerate preparations for record revenue growth.
  • Signed purchase agreement to acquire Appliances Connection, ranked #1 in online appliance retail by USA Today, creating one of the largest independent online retailers of household appliances in the U.S.; upon closing, the Company’s revenue is expected to reach $400M on an annualized basis in 2021, with approximately $30M in EBITDA.

“I am excited report another strong quarter of revenue growth as well as continued sharp improvement in our cash flow from operations,” stated Doug Moore, CEO of 1847 Goedeker. “The increased marketing spend led to record orders and cash on the balance sheet which will convert to revenues as supply of appliances returns closer to normal levels. Customers continue to find our online offering compelling and we will continue to invest in the sea change shift to online appliance buying.”

Moore continued, “We are pleased with the growth in site sessions and orders and with cash flow from operations. The lack of available product meant that we were able to ship only 37% of our orders in the 2020 quarter, compared to more than three years of shipped trends over 80%. The significant increase in orders required us to use temporary staff to supplement our permanent staff in order processing, customer service, and accounting. Had we not experienced supply chain disruptions from COVID-19, we believe that Goedeker’s would have realized $2.5 million to $2.7 million in additional net margin contribution and we believe that expenses would have been reduced by $500k to $750k due to reduction in variable expenses related to lack of supply. A near term look beyond supply constraints point towards mid-term profitability.”

Third Quarter 2020 Financial Highlights:

  • Cash flow from operations improved to $7.4 million in the nine months ended September 30, 2020, up from ($0.7 million) in the prior year period, an $8.1 million improvement.
  • As of September 30, 2020, the Company had $12.4 million of cash and cash equivalents, including unrestricted of $3.5 million and restricted of $8.9 million.
  • Net revenue increased 10.1% to $13.4 million in the quarter ended September 30, 2020, up from $12.2 million in the prior year period. Growth was primarily driven by higher demand resulting from increased advertising spend.
  • Gross profit was $2.2 million, or 16.2% of total net revenue, up 7.5% from the prior year period. Increased gross profit was in line with increased net revenue.
  • Advertising expenses were $1.4 million for the quarter ended September 30, 2020, up from $0.7 million in the prior year period. The increase relates to an increase in advertising spending to drive traffic to our website.
  • Loss from operations in the third quarter of 2020 was $3.1 million. The loss primarily resulted from expenses we incurred in advertising, bank fees, and personnel related to processing the increase in orders that we could not ship at our normal level of shipping because of supply chain issues from our manufacturers. We believe that manufacturers will resolve the supply issues and we will be able to ship product at historical rates. Had we shipped at our normal shipping rates with the same gross margins, our gross profit would have been approximately $4.8 million and our operating income would have been $0.2 million.
  • Driven primarily by non-cash items totaling approximately $4.7 million, net loss before income taxes for the nine-month period ended September 30, 2020, was $10.9 million, as compared to a net loss before income taxes of $2.1 million for the nine months ended September 30, 2019. Excluding non-cash charges, pre-tax net loss for the nine months ended September 30, 2020, would have been $7.6 million.

“We are addressing a $20 billion industry as the only pure play appliance online retailer listed on a major exchange, and we are still at an early stage of capitalizing on this tremendous opportunity,” continued Moore. “Over the past year, we have been investing in people, processes and systems, while developing a world-class advertising and marketing platform in order to continue to drive significant revenue growth and dramatically increase our market share as we continue to execute on our vision of growing Goedeker’s to a billion-dollar revenue company, and in the process, becoming the largest, most profitable online retailer of appliances in the U.S.”

Webcast and Conference Call

The Company will host a conference call and webcast to discuss its third quarter 2020 financial results today at 4:15 p.m. ET. Shareholders and other interested parties may participate in the conference call by dialing 1-833-529-0213 (U.S. Toll-Free) or 1-236-389-2113 (International) a few minutes before the 4:15 p.m. ET start time. An audio-only webcast is also available by visiting:

https://event.on24.com/wcc/r/2634270/06CA6B7A886A4F5763D47A67CBEAF2D8

For interested individuals unable to join the conference call, a dial-in replay of the call will be available until November 30, 2020, and can be accessed by dialing +1-844-512-2921 (U.S. Toll Free) or +1-412-317-6671 (International) and entering replay pin number: 4585388. An archive of the webcast conference call will be available shortly after the call ends at investor.goedekers.com.

About 1847 Goedeker Inc.

The Company is an industry leading e-commerce destination for appliances, furniture, and home goods. Since its founding in 1951, the Company has transformed from a local brick and mortar operation serving the St. Louis metro area to a respected nationwide omnichannel retailer that offers one-stop shopping for national and global brands. While the Company maintains its St. Louis showroom, over 90% of sales are placed through its website (www.goedekers.com). The Company provides visitors an easy to navigate the shopping experience and offers more than 185,000 items organized by category and product features. Specialization in the home category has enabled the Company to build a shopping experience and an advanced logistics infrastructure that is tailored to the unique characteristics of the market. Learn more at www.goedekers.com.

Forward Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the public offering filed with the Securities and Exchange Commission and other reports filed with the Securities and Exchange Commission thereafter. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Non-GAAP to GAAP Reconciliation

This press release contains a financial measure that is not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). The non-GAAP financial measure is net loss before income taxes excluding certain non-cash charges (“Non-GAAP Net Loss before Taxes”).

The non-GAAP financial information should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. Management, however, believes that this non-GAAP financial measure, when used in conjunction with the results presented in accordance with GAAP, may provide a more complete understanding of our results and may facilitate a fuller analysis of our results, particularly in evaluating performance from one period to another. Management has chosen to provide this supplemental information to investors, analysts, and other interested parties to enable them to perform additional analyses of results and to illustrate the results giving effect to the non-GAAP adjustments shown in the reconciliation described in the next paragraph. Furthermore, the economic substance behind our decision to use such non-GAAP measures is that such measures approximate our controllable operating performance more closely than the most directly comparable GAAP financial measures. Management strongly encourages investors to review our financial statements and publicly filed reports in their entirety and cautions investors that the non-GAAP measures used by us may differ from similar measures used by other companies, even when similar terms are used to identify such measures.

As noted above, net loss before income taxes for the nine months ended September 30, 2020, was $10.9 million. Non-GAAP Net Loss before Taxes excludes (i) a loss on early extinguishment of debt of $1,756,095, (ii) a write-off of acquisition receivable of $809,000, and (iii) a non-cash charge related to the change in fair value of a warrant liability of $2,127,656. Accordingly, to reconcile Non-GAAP Net Loss before Taxes to the GAAP measure, net loss before income taxes, we added back these non-cash charges of $4,692,751 to equal GAAP net loss of $10,925,868.

Dave Gentry, CEO

RedChip Companies

Office: 1.800.RED.CHIP (733.2447)

Cell: 407.491.4498

[email protected]

KEYWORDS: Missouri United States North America

INDUSTRY KEYWORDS: Online Retail Home Goods Retail

MEDIA:

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AECOM reports fourth quarter and full year fiscal 2020 results

AECOM reports fourth quarter and full year fiscal 2020 results

LOS ANGELES–(BUSINESS WIRE)–
AECOM (NYSE:ACM), the world’s premier infrastructure consulting firm, today reported fourth quarter and full year fiscal 2020 results.

 

Fourth Quarter Fiscal 2020

 

Full Year Fiscal 2020

(from Continuing Operations; $ in millions, except EPS)

As

Reported

Adjusted1

(Non-GAAP)

As

Reported

YoY %

Change

Adjusted

YoY %

Change

 

As

Reported

Adjusted1

(Non-GAAP)

As

Reported

YoY %

Change

Adjusted

YoY %

Change

Revenue

$3,569

2%

 

$13,240

(3%)

Net Service Revenue (NSR)2

$1,564

(8%3)

 

$6,177

(2%3)

Operating Income

$65

$170

(50%)

(2%)

 

$381

$629

(4%)

16%

Segment Operating Margin4 (NSR)

12.7%

-10 bps

 

12.3%

+160 bps

Net Income

$0

$97

NM

(7%)

 

$170

$347

(19%)

17%

EPS (Fully Diluted)

$0.00

$0.60

NM

(8%)

 

$1.06

$2.15

(20%)

16%

EBITDA5

$204

0%

 

$746

14%

Operating Cash Flow

$649

(18%)

 

$330

(58%)

Free Cash Flow6

$619

(21%)

 

$341

(51%)

Backlog

$41,173

13%7

 

 

 

 

 

Full Year Fiscal 2020 Accomplishments

  • Revenue was $13.2 billion, and net service revenue2 of $6.2 billion declined by 2% compared to the prior year on an organic basis3.
  • Operating income was $381 million and net income decreased by 19% to $170 million; diluted earnings per share was $1.06 and adjusted1 diluted earnings per share was $2.15.
  • Adjusted1 EBITDA5 exceeded the Company’s guidance, increasing by 14% to $746 million, marking a new high for the Professional Services business;
  • The operating income margin decreased by 190 basis points to 1.8% in the fourth quarter and was unchanged with the prior year at 2.9% for the full year.
  • The segment adjusted1 operating margin4 on NSR2 increased by 160 basis points to 12.3%, also a new high for the Professional Services business and 60 basis points above the Company’s prior guidance.
  • Operating cash flow was $330 million and free cash flow6 was $341 million, which exceeded the Company’s guidance range and included $619 million of free cash flow in fourth quarter.
  • The Company expects to a deliver 9% adjusted EBITDA1 growth and 23% adjusted EPS1 growth in fiscal 2021 at the mid-point of its respective guidance ranges.
  • The Company has executed $455 million of stock repurchases since the beginning of September 2020, which reduced the diluted share count by approximately 6.5% to date.
  • Consistent with its plan to return substantially all available cash and free cash flow to shareholders, the Company announced today an increase to the existing remaining Board repurchase authorization from $305 million to $1 billion, positioning the Company to continue repurchase substantial stock in fiscal 2021.
  • In October 2020, the Company continued its transformation to a higher-margin and lower-risk Professional Services business with the completed disposition of the Power construction business and in January 2020 the completed sale of the Management Services business.
  • The Company also announced today its Think and Act Globally strategy aimed at setting a new standard of excellence for the Professional Services industry by extending its global expertise to each of its projects and clients around the world through enhanced collaboration, transforming the way it delivers work through technology and digital platforms, and enhancing its position as a leading ESG company.

Fiscal 2021 Financial Guidance

  • The Company expects in fiscal 2021 adjusted net income1 of between $390 million and $420 million, adjusted EPS1 of between $2.55 and $2.75, and adjusted1 EBITDA5 of between $790 million and $830 million.

    – At the mid-point of its respective ranges, the Company is forecasting 9% adjusted EBITDA growth and 23% adjusted EPS growth over fiscal 2020.

    – This guidance includes an expected additional 90 basis point improvement in the segment adjusted1 operating margin4 to 13.2%, reflecting the benefits from restructuring actions taken in FY’20 that are expected to contribute to improved margins in both the Company’s Americas and International segments.

    – The Company’s adjusted EPS guidance assumes an average diluted share count of 153 million, which is inclusive of shares repurchased through November 13, 2020.
  • The Company also provided guidance for fiscal 2021 free cash flow6 of between $425 million and $625 million, which is consistent with the highly cash generative nature of the Professional Services business. The guidance is based on anticipated cash flow from operations of $535 million to $735 million less capital expenditures, net of proceeds from disposal, of approximately $110 million.
  • Underlying the Company’s confidence in fiscal 2021 and beyond are several favorable attributes inherent in its Professional Services business that allow for consistent performance through periods of uncertainty, including an agile workforce with a proven ability to remain productive while working remotely, a consolidated design business under one global organization, a highly variable cost structure, a substantial backlog with several years of visibility and a highly cash generative business profile.

“I am incredibly proud of how our teams responded to the unprecedented challenges of the past year to deliver for our clients and communities and to position the business for continued success in 2021 and beyond,” said Troy Rudd, AECOM’s chief executive officer. “I am grateful to our professionals for their focus on the health safety of their families and clients, and on the health of our business. We are committed to setting a new standard of excellence in the Professional Services industry.”

“Our teams are energized by our achievements in fiscal 2020 and in the opportunities that lay ahead,” said Lara Poloni, AECOM’s president. “We are focusing on the best market opportunities and removing barriers that hindered our ability to deliver our global expertise to each of our local projects. Our efforts on ESG are just one example of where we have assembled global teams to both advance ESG within AECOM and also shape how our clients achieve their sustainability and social visions.”

“We delivered strong EBITDA growth and free cash flow, which, along with the sale of the Management Services, contributed to a substantial debt reduction and the commencement of share repurchases,” said Gaurav Kapoor, AECOM’s chief financial officer. “We remain focused on the health of our people and continuing to build the strength of our business. We are committed to promoting a culture of continuous margin improvement as we march towards our 15% long-term target, and returning substantially all available cash and free cash flow to investors through share repurchases. The Board has authorized an increase to the existing share repurchase program to $1 billion, creating the authority to continue to repurchase stock with substantially all available cash and free cash flow.”

Wins and Backlog

Full year wins of $18.2 billion resulted in a book-to-burn ratio8 of 1.3, which was highlighted by a 1.4 book-to-burn ratio in the Americas segment. Total backlog remains at near-record levels and increased by 13%7 over the prior year to $41.2 billion. In addition, contracted backlog increased by 12% over the prior year, providing for solid levels of visibility.

Business Segments

AECOM is a Professional Services firm that delivers planning, design, engineering, consulting and construction management services to public- and private-sector clients worldwide in markets spanning transportation, buildings, water, governments, energy and the environment.

AECOM reports its financial results based on three segments: Americas, which consists of the Company’s business in the United States, Canada and Latin America; International, which consists of the Company’s business in Europe, the Middle East, Africa and the Asia-Pacific regions; and AECOM Capital.

In addition, the Management Services (MS) business, which was sold in January 2020, and the at-risk, self-perform construction businesses that the Company has either exited or intends to exit are reported as discontinued operations.

Americas

Revenue in the fourth quarter was $2.7 billion, a 2% increase from the prior year. Full year revenue was $10.1 billion, a 2% decrease from the prior year.

Net service revenue2 was $929 million in the fourth quarter, a 6% decrease from the prior year on a constant-currency organic basis3. Full year net service revenue was $3.7 billion, which declined by 1% on a constant-currency organic basis and included a slight decline in the Americas design business, which was partially offset by growth in the Construction Management business.

Fourth quarter operating income was $153 million compared to $149 million in the year-ago period. On an adjusted basis1, operating income was $157 million compared to $163 million in the year-ago period. For the full year, operating income was $600 million compared to $518 million in the prior year. On an adjusted basis, full year operating income was $619 million compared to $555 million in the prior year. The full year adjusted operating margin on an NSR2 basis of 16.8% was a 160 basis point increase over the prior year, which reflects the benefits of the many strategic actions taken to enhance margins and is a new high for the Company on both a GAAP and adjusted basis.

International

Revenue in the fourth quarter was $831 million, which was unchanged over the prior year. Full year revenue was $3.1 billion, a 5% decrease from the prior year.

Net service revenue2 was $630 million in the fourth quarter, a 11% decrease from the prior year on a constant-currency organic3 basis. Full year net service revenue was $2.5 billion, a 4% decrease from the prior year on a constant-currency organic basis, which included single-digit declines in both the EMEA and Asia-Pacific regions.

Fourth quarter operating income was $40 million compared to $35 million in the year-ago period. On an adjusted basis1, operating income was $41 million compared to $37 million in the year-ago period. Full year operating income was $137 million compared to $105 million in the prior year. On an adjusted basis, full year operating income was $142 million compared to $110 million in the prior year. The full year adjusted operating margin on an NSR2 basis increased by 150 basis points over the prior year to 5.7%. The benefits of real estate restructuring, a streamlined G&A structure and ongoing exit from more than 30 countries enabled the Company to deliver margin improvement despite a decline in revenue. Continued improvement in the Company’s International margins towards a long-term target of double-digit margins remains a key priority.

AECOM Capital

The AECOM Capital segment invests in and develops real estate projects. Revenue in the fourth quarter was $5.6 million and operating income was $11.0 million, which benefitted from the sale of property investments that generated a greater than 20% IRR. Full year operating income was $13.0 million. The Company expects between $5 million and $10 million of AECOM Capital earnings in fiscal 2021.

Discontinued Operations

Following the close of the fourth quarter, AECOM closed on the sale of the Power construction business. Results for discontinued operations included a $247 million impairment to assets held for sale as part of the Company’s continued progress to exit its self-perform, at-risk construction businesses.

Cash Flow

Operating cash flow for the fourth quarter was $649 million and free cash flow6 was $619 million. Full year operating cash flow was $330 million and free cash flow was $341 million, which exceeded the high end of the Company’s guidance range. The Company’s full year free cash flow included the receipt of $122 million in connection with a previously announced favorable net working capital purchase price adjustment collected in May 2020 in connection with the sale of the Management Services business, which is included in the investing section of the cash flow statement in accordance with GAAP.

Balance Sheet & Capital Allocation

As of September 30, 2020, inclusive of discontinued operations, AECOM had $1.8 billion of total cash and cash equivalents, $2.1 billion of total debt, $250 million of net debt and was undrawn under its $1.35 billion revolving credit facility. Gross leverage9 declined to 2.7x and net leverage9 declined to 0.3x.

With the expected continued strong cash generation in the business and substantial access to liquidity, the Company has executed $455 million of stock repurchases since the beginning of September, which reduced its diluted share count by approximately 6.5%. The Company remains committed to returning substantially all available cash and free cash flow to shareholders through stock repurchases. In November, the Board approved an increase to the existing repurchase authorization to $1 billion.

Tax Rate

The effective tax rate was 79.8% in the fourth quarter and 19.7% in the full year. The fourth quarter effective tax rate was influenced by non-deductible expenses and foreign earnings taxed in the United States. On an adjusted basis, the effective tax rate was 30.0% in the fourth quarter and 28.5% in the full year. The adjusted tax rate was derived by re-computing the annual effective tax rate on earnings from adjusted net income.10 The adjusted tax expense differs from the GAAP tax expense based on the taxability or deductibility and tax rate applied to each of the adjustments.

Restructuring Update

AECOM continues to advance its previously announced restructuring actions that are expected to deliver continued substantial margin improvement and efficiencies that result in a more agile organization. As a result, the Company expects to incur restructuring expenses in fiscal 2021 of between $30 million and $50 million, which will be excluded from the Company’s adjusted results.

Conference Call

AECOM is hosting a conference call today at 12 p.m. Eastern Time, during which management will make a brief presentation focusing on the Company’s results, strategies and operating trends. Interested parties can listen to the conference call and view accompanying slides via webcast at https://investors.aecom.com. The webcast will be available for replay following the call.

1 Excludes the impact of non-operating items, such as non-core operating losses and transaction-related expenses, restructuring costs and other items. See Regulation G Information for a complete reconciliation of non-GAAP measures to the comparable GAAP measures.

2 Revenue, net of subcontractor and other direct costs.

3 Organic growth is calculated at constant currency, reflects revenue associated with continuing operations and excludes the impact of the 53rd week in the fourth quarter of fiscal 2020. Results expressed in constant currency are presented excluding the impact from changes in currency exchange rates.

4 Reflects segment operating performance, excluding AECOM Capital.

5 Net income before interest expense, tax expense, depreciation and amortization.

6 Free cash flow is defined as cash flow from operations less capital expenditures net of proceeds from disposals and includes the receipt of a favorable $122 million net working capital purchase price adjustment collected in May 2020 in connection with the sale of the Management Services (MS) business. The working capital adjustment represents the recovery of an operating cash flow shortfall of the MS business prior to its sale.

7 On a constant-currency basis.

8 Book-to-burn ratio is defined as the dollar amount of wins divided by revenue recognized during the period, including revenue related to work performed in unconsolidated joint ventures.

9 Gross leverage is comprised of EBITDA as defined in the Company’s credit agreement dated October 17, 2014, as amended, which excludes stock-based compensation, and total debt on the Company’s financial statements; net leverage is defined similarly but is also net of total cash and cash equivalents.

10 Inclusive of non-controlling interest deduction and adjusted for financing charges in interest expense, the amortization of intangible assets and is based on continuing operations.

About AECOM

AECOM (NYSE:ACM) is the world’s premier infrastructure consulting firm, delivering professional services throughout the project lifecycle – from planning, design and engineering to program and construction management. On projects spanning transportation, buildings, water, energy and the environment, our public- and private-sector clients trust us to solve their most complex challenges. Our teams are driven by a common purpose to deliver a better world through our unrivaled technical expertise and innovation, a culture of equity, diversity and inclusion, and a commitment to environmental, social and governance priorities. AECOM is a Fortune 500 firm and its Professional Services business had revenue of $13.2 billion in fiscal year 2020. See how we deliver what others can only imagine at aecom.com and @AECOM.

Forward-Looking Statements

All statements in this communication other than statements of historical fact are “forward-looking statements” for purposes of federal and state securities laws, including any statements of the plans, strategies and objectives for future operations, profitability, strategic value creation, coronavirus impacts, risk profile and investment strategies, and any statements regarding future economic conditions or performance, and the expected financial and operational results of AECOM. Although we believe that the expectations reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in any of our forward-looking statements. Important factors that could cause our actual results, performance and achievements, or industry results to differ materially from estimates or projections contained in our forward-looking statements include, but are not limited to, the following: our business is cyclical and vulnerable to economic downturns and client spending reductions; impacts caused by the coronavirus and the related economic instability and market volatility, including the reaction of governments to the coronavirus, including any prolonged period of travel, commercial or other similar restrictions, the delay in commencement, or temporary or permanent halting of construction, infrastructure or other projects, requirements that we remove our employees or personnel from the field for their protection, and delays or reductions in planned initiatives by our governmental or commercial clients or potential clients; losses under fixed-price contracts; limited control over operations run through our joint venture entities; liability for misconduct by our employees or consultants; failure to comply with laws or regulations applicable to our business; maintaining adequate surety and financial capacity; high leverage and potential inability to service our debt and guarantees; exposure to Brexit; exposure to political and economic risks in different countries; currency exchange rate fluctuations; retaining and recruiting key technical and management personnel; legal claims; inadequate insurance coverage; environmental law compliance and adequate nuclear indemnification; unexpected adjustments and cancellations related to our backlog; partners and third parties who may fail to satisfy their legal obligations; AECOM Capital real estate development projects; managing pension cost; cybersecurity issues, IT outages and data privacy; risks associated with the benefits and costs of the Management Services transaction, including the risk that the expected benefits of the Management Services transaction or any contingent purchase price will not be realized within the expected time frame, in full or at all; the risk that costs of restructuring transactions and other costs incurred in connection with the Management Services transaction will exceed our estimates or otherwise adversely affect our business or operations; as well as other additional risks and factors that could cause actual results to differ materially from our forward-looking statements set forth in our reports filed with the Securities and Exchange Commission. Any forward-looking statements are made as of the date hereof. We do not intend, and undertake no obligation, to update any forward-looking statement.

Non-GAAP Financial Information

This press release contains financial information calculated other than in accordance with U.S. generally accepted accounting principles (“GAAP”). The Company believes that non-GAAP financial measures such as adjusted EPS, adjusted EBITDA, adjusted net/operating income, adjusted tax rate, net service revenue and free cash flow provide a meaningful perspective on its business results as the Company utilizes this information to evaluate and manage the business. We use adjusted EBITDA, adjusted EPS, adjusted net/operating income and adjusted tax rate to exclude the impact of non-operating items, such as amortization expense, taxes and non-core operating losses to aid investors in better understanding our core performance results. We use free cash flow to represent the cash generated after capital expenditures to maintain our business. We present constant currency information to help assess how our underlying businesses performed excluding the effect of foreign currency rate fluctuations to aid investors in better understanding our international operational performance. We present net service revenue to exclude subcontractor costs from revenue to provide investors with a better understanding of our operational performance. We present segment adjusted operating margin to reflect segment operating performance of our Americas and International segments, excluding AECOM Capital.

Our non-GAAP disclosure has limitations as an analytical tool, should not be viewed as a substitute for financial information determined in accordance with GAAP, and should not be considered in isolation or as a substitute for analysis of our results as reported under GAAP, nor is it necessarily comparable to non-GAAP performance measures that may be presented by other companies. A reconciliation of these non-GAAP measures is found in the Regulation G Information tables at the back of this release.

AECOM

Consolidated Statements of Income

(in thousands, except per share data)

 

 

 

Three Months Ended

 

Twelve Months Ended

 

 

 

Sep 30,

2019

 

 

Sep 30,

2020

 

 

%

Change

 

Sep 30,

2019

 

 

Sep 30,

2020

 

 

%

Change

 

Revenue

 

$

3,513,483

 

$

3,568,950

 

1.6%

 

$

13,642,455

 

$

13,239,976

 

(3.0)%

 

Cost of revenue

 

3,323,916

 

3,379,082

 

1.7%

 

13,030,800

 

12,530,416

 

(3.8)%

 

Gross profit

 

189,567

 

189,868

 

0.2 %

 

611,655

 

709,560

 

16.0 %

 

Equity in earnings of joint ventures

 

16,902

 

16,775

 

(0.8)%

 

49,320

 

48,781

 

(1.1)%

 

General and administrative expenses

 

(37,256

)

(49,402

)

32.6 %

 

(148,123

)

(188,535

)

27.3 %

 

Restructuring costs

 

(16,276

)

(91,907

)

464.7 %

 

(95,446

)

(188,345

)

97.3 %

 

Gain on disposal activities

 

3,590

 

 

(100.0)%

 

3,590

 

 

(100.0)%

 

Impairment of long-lived assets

 

(24,900

)

 

(100.0)%

 

(24,900

)

 

(100.0)%

 

Income from operations

 

131,627

 

65,334

 

(50.4)%

 

396,096

 

381,461

 

(3.7)%

 

Other income

 

3,481

 

1,499

 

(56.9)%

 

14,556

 

11,056

 

(24.0)%

 

Interest expense

 

(40,153

)

(47,501

)

18.3 %

 

(161,482

)

(159,914

)

(1.0)%

 

Income from continuing operations before taxes

 

94,955

 

19,332

 

(79.6)%

 

249,170

 

232,603

 

(6.6)%

 

Income tax expense for continuing operations

 

16,612

 

15,427

 

(7.1)%

 

13,498

 

45,753

 

239.0 %

 

Net income from continuing operations

 

78,343

 

3,905

 

(95.0)%

 

235,672

 

186,850

 

(20.7)%

 

Net loss from discontinued operations

 

(526,326

)

(227,896

)

(56.7)%

 

(419,662

)

(340,591

)

(18.8)%

 

Net loss

 

(447,983

)

(223,991

)

(50.0)%

 

(183,990

)

(153,741

)

(16.4)%

 

Net income attributable to noncontrolling interest from continuing operations

 

(6,780

)

(3,970

)

(41.4)%

 

(24,710

)

(16,398

)

(33.6)%

 

Net income attributable to noncontrolling interest from discontinued operations

 

(19,389

)

(2,226

)

(88.5)%

 

(52,350

)

(16,231

)

(69.0)%

 

Net income attributable to noncontrolling interest

 

(26,169

)

(6,196

)

(76.3)%

 

(77,060

)

(32,629

)

(57.7)%

 

Net income (loss) attributable to AECOM from continuing operations

 

71,563

 

(65

)

(100.1)%

 

210,962

 

170,452

 

(19.2)%

 

Net loss attributable to AECOM from discontinued operations

 

(545,715

)

(230,122

)

(57.8)%

 

(472,012

)

(356,822

)

(24.4)%

 

Net loss attributable to AECOM

 

$

(474,152

)

$

(230,187

)

(51.5)%

 

$

(261,050

)

$

(186,370

)

(28.6)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income (loss) attributable to AECOM per share:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

0.45

 

$

 

(100.0)%

 

$

1.34

 

$

1.07

 

(20.1)%

 

Discontinued operations

 

 

(3.46

)

 

(1.44

)

(58.4)%

 

 

(3.00

)

 

(2.24

)

(25.3)%

 

Basic earnings per share

 

$

(3.01

)

$

(1.44

)

(52.2)%

 

 

(1.66

)

 

(1.17

)

(29.5)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Diluted

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Continuing operations

 

$

0.44

 

$

 

(100.0)%

 

$

1.32

 

$

1.06

 

(19.7)%

 

Discontinued operations

 

(3.39

)

(1.44

)

(57.5)%

 

(2.95

)

(2.22

)

(24.7)%

 

Diluted earnings (loss) per share

 

$

(2.95

)

$

(1.44

)

(51.2)%

 

$

(1.63

)

$

(1.16

)

(28.8)%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

 

 

 

 

Basic

 

157,709

 

160,020

 

1.5 %

 

157,044

 

159,005

 

1.2 %

 

Diluted

 

160,929

 

160,020

 

(0.6)%

 

159,684

 

161,292

 

1.0 %

 

AECOM

Balance Sheet Information

(in thousands)

 

 

September 30,

2019

 

 

September 30,

2020

 

 

Balance Sheet Information:

 

 

 

 

 

 

Total cash and cash equivalents

$

885,639

 

 

$

1,708,332

 

 

Accounts receivable and contract assets – net

 

4,451,022

 

 

 

4,402,277

 

 

Working capital

 

1,072,891

 

 

 

1,439,912

 

 

Total debt, excluding unamortized debt issuance costs

 

3,352,464

 

 

 

2,085,017

 

 

Total assets

 

14,550,908

 

 

 

12,998,951

 

 

Total AECOM stockholders’ equity

 

3,690,576

 

 

 

3,292,558

 

 

AECOM

 

Reportable Segments

 

(in thousands)

 

 

 

Americas

 

International

 

AECOM

Capital

 

Corporate

 

Total

 

Three Months Ended September 30, 2020

Revenue

 

$

2,732,266

 

$

831,105

 

$

5,579

 

$

 

$

3,568,950

 

Cost of revenue

 

 

2,582,081

 

 

797,001

 

 

 

 

 

 

3,379,082

 

Gross profit

 

 

150,185

 

 

34,104

 

 

5,579

 

 

 

 

189,868

 

Equity in earnings of joint ventures

 

 

2,493

 

 

5,597

 

 

8,685

 

 

 

 

16,775

 

General and administrative expenses

 

 

 

 

 

 

(3,239

)

 

(46,163

)

 

(49,402

)

Restructuring costs

 

 

 

 

 

 

 

 

(91,907

)

 

(91,907

)

Income (loss) from operations

 

$

152,678

 

$

39,701

 

$

11,025

 

$

(138,070

)

$

65,334

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit as a % of revenue

 

 

5.5%

 

 

4.1%

 

 

 

 

 

 

5.3%

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended September 30, 2019

Revenue

 

$

2,681,902

 

$

830,245

 

$

1,336

 

$

 

$

3,513,483

 

Cost of revenue

 

 

2,527,292

 

 

796,624

 

 

 

 

 

 

3,323,916

 

Gross profit

 

 

154,610

 

 

33,621

 

 

1,336

 

 

 

 

189,567

 

Equity in earnings of joint ventures

 

 

4,915

 

 

2,245

 

 

9,742

 

 

 

 

16,902

 

General and administrative expenses

 

 

 

 

 

 

(26

)

 

(37,230

)

 

(37,256

)

Restructuring costs

 

 

 

 

 

 

 

 

(16,276

)

 

(16,276

)

Gain on disposal activities

 

 

 

 

3,590

 

 

 

 

 

 

3,590

 

Impairment of long-lived assets

 

 

(10,800

)

 

(4,400

)

 

 

 

(9,700

)

 

(24,900

)

Income (loss) from operations

 

$

148,725

 

$

35,056

 

$

11,052

 

$

(63,206

)

$

131,627

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit as a % of revenue

 

 

5.8%

 

 

4.0%

 

 

 

 

 

 

5.4%

 

 

 

 

 

 

 

 

 

 

 

 

 

AECOM

 

Reportable Segments

 

(in thousands)

 

 

 

Americas

 

 

International

 

 

AECOM

Capital

 

 

Corporate

 

 

Total

 

Twelve Months Ended September 30, 2020

Revenue

 

$

10,131,479

 

$

3,101,682

 

$

6,815

 

$

 

$

13,239,976

 

Cost of revenue

 

 

9,550,978

 

 

2,979,438

 

 

 

 

 

 

12,530,416

 

Gross profit

 

 

580,501

 

 

122,244

 

 

6,815

 

 

 

 

709,560

 

Equity in earnings of joint ventures

 

 

19,816

 

 

14,269

 

 

14,696

 

 

 

 

48,781

 

General and administrative expenses

 

 

 

 

 

 

(8,511

)

 

(180,024

)

 

(188,535

)

Restructuring costs

 

 

 

 

 

 

 

 

(188,345

)

 

(188,345

)

Income (loss) from operations

 

$

600,317

 

$

136,513

 

$

13,000

 

$

(368,369

)

$

381,461

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit as a % of revenue

 

 

5.7%

 

 

3.9%

 

 

 

 

 

 

5.4%

 

 

 

 

 

 

 

 

 

 

 

 

 

Contracted backlog

 

$

15,796,146

 

$

3,745,064

 

 

 

 

 

$

19,541,210

 

Awarded backlog

 

 

20,108,489

 

 

982,591

 

 

 

 

 

 

21,091,080

 

Unconsolidated JV backlog

 

 

540,605

 

 

 

 

 

 

 

 

540,605

 

Total backlog

 

$

36,445,240

 

$

4,727,655

 

 

 

 

 

$

41,172,895

 

 

 

 

 

 

 

 

 

 

 

 

 

Twelve Months Ended September 30, 2019

Revenue

 

$

10,382,605

 

$

3,251,651

 

$

8,199

 

$

 

$

13,642,455

 

Cost of revenue

 

 

9,871,090

 

 

3,159,710

 

 

 

 

 

 

13,030,800

 

Gross profit

 

 

511,515

 

 

91,941

 

 

8,199

 

 

 

 

611,655

 

Equity in earnings of joint ventures

 

 

17,677

 

 

13,903

 

 

17,740

 

 

 

 

49,320

 

General and administrative expenses

 

 

 

 

 

 

(4,926

)

 

(143,197

)

 

(148,123

)

Restructuring costs

 

 

 

 

 

 

 

 

(95,446

)

 

(95,446

)

Gain on disposal activities

 

 

 

 

3,590

 

 

 

 

 

 

3,590

 

Impairment of long-lived assets

 

 

(10,800

)

 

(4,400

)

 

 

 

(9,700

)

 

(24,900

)

Income (loss) from operations

 

$

518,392

 

$

105,034

 

$

21,013

 

$

(248,343

)

$

396,096

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit as a % of revenue

 

 

4.9%

 

 

2.8%

 

 

 

 

 

 

4.5%

 

 

 

 

 

 

 

 

 

 

 

 

 

Contracted backlog

 

$

13,854,420

 

$

3,645,322

 

 

 

 

 

$

17,499,742

 

Awarded backlog

 

 

17,216,081

 

 

818,964

 

 

 

 

 

 

18,035,045

 

Unconsolidated JV backlog

 

 

993,204

 

 

 

 

 

 

 

 

993,204

 

Total backlog

 

$

32,063,705

 

$

4,464,286

 

 

 

 

 

$

36,527,991

 

 

 

 

 

 

 

 

 

 

 

 

 

AECOM

Regulation G Information

(in millions)

 

Reconciliation of Revenue to Revenue, Net of Subcontractor and Other Direct Costs (NSR)

 

Three Months Ended

 

Twelve Months Ended

 

 

Sep 30,

2019

 

Jun 30,

2020

 

Sep 30,

2020

 

Sep 30,

2019

 

Sep 30,

2020

 

Americas

 

 

 

 

 

 

 

 

 

 

Revenue

$

2,681.9

 

$

2,471.5

 

$

2,732.3

 

$

10,382.6

 

$

10,131.5

 

Less: subcontractor and other direct costs

 

1,761.3

 

 

1,548.5

 

 

1,803.2

 

 

6,737.9

 

 

6,440.6

 

Revenue, net of subcontractor and other direct costs

$

920.6

 

$

923.0

 

$

929.1

 

$

3,644.7

 

$

3,690.9

 

 

 

 

 

 

 

 

 

 

 

 

International

 

 

 

 

 

 

 

 

 

 

Revenue

$

830.2

 

$

718.0

 

$

831.1

 

$

3,251.7

 

$

3,101.7

 

Less: subcontractor and other direct costs

 

184.7

 

 

128.5

 

 

201.3

 

 

682.0

 

 

622.5

 

Revenue, net of subcontractor and other direct costs

$

645.5

 

$

589.5

 

$

629.8

 

$

2,569.7

 

$

2,479.2

 

 

 

 

 

 

 

 

 

 

 

 

Segment Performance (excludes ACAP)

 

 

 

 

 

 

 

 

 

 

Revenue

$

3,512.1

 

$

3,189.5

 

$

3,563.4

 

$

13,634.3

 

$

13,233.2

 

Less: subcontractor and other direct costs

 

1,946.0

 

 

1,677.0

 

 

2,004.5

 

 

7,419.9

 

 

7,063.1

 

Revenue, net of subcontractor and other direct costs

$

1,566.1

 

$

1,512.5

 

$

1,558.9

 

$

6,214.4

 

$

6,170.1

 

 

 

 

 

 

 

 

 

 

 

 

Consolidated

 

 

 

 

 

 

 

 

 

 

Revenue

$

3,513.4

 

$

3,189.7

 

$

3,569.0

 

$

13,642.5

 

$

13,240.0

 

Less: subcontractor and other direct costs

 

1,946.0

 

 

1,677.0

 

 

2,004.5

 

 

7,419.9

 

 

7,063.1

 

Revenue, net of subcontractor and other direct costs

$

1,567.4

 

$

1,512.7

 

$

1,564.5

 

$

6,222.6

 

$

6,176.9

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Total Debt to Net Debt

 

Balances at:

 

 

Sep 30,

2019

 

Jun 30,

2020

 

Sep 30,

2020

 

Short-term debt

$

47.9

 

$

10.4

 

$

0.2

 

Current portion of long-term debt

 

50.5

 

 

14.3

 

 

20.7

 

Long-term debt, gross

 

3,254.1

 

 

2,071.6

 

 

2,064.1

 

Total debt, excluding unamortized debt issuance costs

 

3,352.5

 

 

2,096.3

 

 

2,085.0

 

Less: Total cash and cash equivalents

 

885.6

 

 

1,331.3

 

 

1,708.3

 

Net debt

$

2,466.9

 

$

765.0

 

$

376.7

 

Reconciliation of Net Cash Provided by Operating Activities to Free Cash Flow

 

Three Months Ended

 

 

Twelve Months Ended

 

 

Sep 30,

2019

 

 

Jun 30,

2020

 

 

Sep 30,

2020

 

 

Sep 30,

2019

 

 

Sep 30,

2020

 

Net cash provided by operating activities

$

793.7

 

 

$

186.3

 

 

$

649.3

 

 

$

777.6

 

 

$

329.6

 

Capital expenditures, net

 

(14.3

)

 

 

(36.3

)

 

 

(30.0

)

 

 

(83.4

)

 

 

(110.8

)

Working capital adjustment from sale of Management Services business

 

 

 

 

122.0

 

 

 

 

 

 

 

 

 

122.0

 

Free cash flow

$

779.4

 

 

$

272.0

 

 

$

619.3

 

 

$

694.2

 

 

$

340.8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Note: Variances within tables are due to rounding.

AECOM

Regulation G Information

(in millions, except per share data)

 

Three Months Ended

 

Twelve Months Ended

 

 

Sep 30,

2019

 

Jun 30,

2020

 

Sep 30,

2020

 

Sep 30,

2019

 

Sep 30,

2020

 

Reconciliation of Income from Operations to Adjusted Income from Operations

Income from operations

$

131.6

 

$

118.9

 

$

65.3

 

$

396.1

 

$

381.5

 

Noncore operating losses & transaction related expenses

 

(1.2

)

 

 

 

 

 

4.5

 

 

5.6

 

Accelerated depreciation of project management tool

 

 

 

11.3

 

 

6.9

 

 

 

 

29.5

 

Impairment of long-lived assets

 

24.9

 

 

 

 

 

 

24.9

 

 

 

Restructuring costs

 

16.2

 

 

20.3

 

 

91.9

 

 

95.4

 

 

188.3

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Amortization of intangible assets

 

6.2

 

 

5.9

 

 

5.8

 

 

25.2

 

 

24.0

 

Adjusted income from operations

$

174.1

 

$

156.4

 

$

169.9

 

$

542.5

 

$

628.9

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Income from Continuing Operations Before Taxes to Adjusted Income from Continuing Operations Before Taxes

Income from continuing operations before taxes

$

94.9

 

$

87.1

 

$

19.3

 

$

249.1

 

$

232.6

 

Noncore operating losses & transaction related expenses

 

(1.2

)

 

 

 

 

 

4.5

 

 

5.6

 

Accelerated depreciation of project management tool

 

 

 

11.3

 

 

6.9

 

 

 

 

29.5

 

Impairment of long-lived assets

 

24.9

 

 

 

 

 

 

24.9

 

 

 

Restructuring costs

 

16.2

 

 

20.3

 

 

91.9

 

 

95.4

 

 

188.3

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Amortization of intangible assets

 

6.2

 

 

5.9

 

 

5.8

 

 

25.2

 

 

24.0

 

Financing charges in interest expense

 

3.4

 

 

1.3

 

 

18.6

 

 

10.7

 

 

22.8

 

Adjusted income from continuing operations before taxes

$

140.8

 

$

125.9

 

$

142.5

 

$

406.2

 

$

502.8

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Income Taxes for Continuing Operations to Adjusted Income Taxes for Continuing Operations

Income tax expense (benefit) for continuing operations

$

16.6

 

$

(7.2

)

$

15.5

 

$

13.5

 

$

45.8

 

Tax effect of the above adjustments*

 

9.6

 

 

9.9

 

 

32.7

 

 

39.6

 

 

69.2

 

Valuation allowances and other tax only items

 

3.6

 

 

31.7

 

 

(6.7

)

 

30.2

 

 

23.5

 

Adjusted income tax expense for continuing operations

$

29.8

 

$

34.4

 

$

41.5

 

$

83.3

 

$

138.5

 

____________________

*Adjusts the income tax expense (benefit) during the period to exclude the impact on our effective tax rate of the pre-tax adjustments shown above.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Net Income Attributable to Noncontrolling Interest from Continuing Operations to Adjusted Net Income Attributable to Noncontrolling Interests from Continuing Operations

Net income attributable to noncontrolling interests from continuing operations

$

(6.8

)

$

(3.1

)

$

(4.0

)

$

(24.7

)

$

(16.4

)

Amortization of intangible assets included in NCI, net of tax

 

(0.2

)

 

(0.1

)

 

(0.2

)

 

(0.6

)

 

(0.5

)

Adjusted net income attributable to noncontrolling interests from continuing operations

$

(7.0

)

$

(3.2

)

$

(4.2

)

$

(25.3

)

$

(16.9

)

Reconciliation of Net Income (Loss) Attributable to AECOM from Continuing Operations to Adjusted Net Income Attributable to AECOM from Continuing Operations

Net income (loss) attributable to AECOM from continuing operations

$

71.5

 

$

91.1

 

$

(0.1

)

$

210.9

 

$

170.4

 

Noncore operating losses & transaction related expenses

 

(1.2

)

 

 

 

 

 

4.5

 

 

5.6

 

Accelerated depreciation of project management tool

 

 

 

11.3

 

 

6.9

 

 

 

 

29.5

 

Impairment of long-lived assets

 

24.9

 

 

 

 

 

 

24.9

 

 

 

Restructuring costs

 

16.2

 

 

20.3

 

 

91.9

 

 

95.4

 

 

188.3

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Amortization of intangible assets

 

6.2

 

 

5.9

 

 

5.8

 

 

25.2

 

 

24.0

 

Financing charges in interest expense

 

3.4

 

 

1.3

 

 

18.6

 

 

10.7

 

 

22.8

 

Tax effect of the above adjustments*

 

(9.6

)

 

(9.8

)

 

(32.7

)

 

(39.7

)

 

(69.2

)

Valuation allowances and other tax only items

 

(3.6

)

 

(31.7

)

 

6.7

 

 

(30.2

)

 

(23.5

)

Amortization of intangible assets included in NCI, net of tax

 

(0.2

)

 

(0.1

)

 

(0.2

)

 

(0.6

)

 

(0.5

)

Adjusted net income attributable to AECOM from continuing operations

$

104.0

 

$

88.3

 

$

96.9

 

$

297.5

 

$

347.4

 

____________________

* Adjusts the income tax expense (benefit) during the period to exclude the impact on our effective tax rate of the pre-tax adjustments shown above.

Note: Variances within tables are due to rounding.

AECOM

Regulation G Information

(in millions, except per share data)

 

 

Three Months Ended

 

 

Twelve Months Ended

 

 

Sep 30,

2019

 

 

Jun 30,

2020

 

 

Sep 30,

2020

 

 

Sep 30,

2019

 

 

Sep 30,

2020

 

Reconciliation of Net Income Attributable to AECOM from Continuing Operations per Diluted Share to Adjusted Net Income Attributable to AECOM from Continuing Operations per Diluted Share

Net income attributable to AECOM from continuing operations per diluted share

$

0.44

 

$

0.56

 

$

 

$

1.32

 

$

1.06

 

Per diluted share adjustments:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Noncore operating losses & transaction related expenses

 

 

 

 

 

 

 

0.02

 

 

0.03

 

Accelerated depreciation of project management tool

 

 

 

0.07

 

 

0.04

 

 

 

 

0.18

 

Impairment of long-lived assets

 

0.15

 

 

 

 

 

 

0.16

 

 

 

Restructuring costs

 

0.10

 

 

0.13

 

 

0.57

 

 

0.60

 

 

1.17

 

Gain on disposal activities

 

(0.02

)

 

 

 

 

 

(0.02

)

 

 

Amortization of intangible assets

 

0.04

 

 

0.04

 

 

0.04

 

 

0.16

 

 

0.15

 

Financing charges in interest expense

 

0.02

 

 

0.01

 

 

0.11

 

 

0.07

 

 

0.14

 

Tax effect of the above adjustments*

 

(0.06

)

 

(0.06

)

 

(0.20

)

 

(0.25

)

 

(0.43

)

Valuation allowances and other tax only items

 

(0.02

)

 

(0.20

)

 

0.04

 

 

(0.19

)

 

(0.15

)

Amortization of intangible assets included in NCI, net of tax

 

 

 

 

 

 

 

(0.01

)

 

 

Adjusted net income attributable to AECOM from continuing operations per diluted share

$

0.65

 

$

0.55

 

$

0.60

 

$

1.86

 

$

2.15

 

Weighted average shares outstanding – basic

 

157.7

 

 

160.1

 

 

160.0

 

 

157.0

 

 

159.0

 

Weighted average shares outstanding – diluted

 

160.9

 

 

161.8

 

 

162.0

 

 

159.7

 

 

161.3

 

____________________

* Adjusts the income tax expense (benefit) during the period to exclude the impact on our effective tax rate of the pre-tax adjustments shown above.

 

 

 

 

 

 

 

 

 

 

 

Reconciliation of Net Income Attributable to AECOM from Continuing Operations to EBITDA to Adjusted EBITDA and to Adjusted Income from Operations

Net income attributable to AECOM from continuing operations

$

71.5

 

$

91.1

 

$

(0.1

)

$

210.9

 

$

170.4

 

Income tax expense (benefit)

 

16.6

 

 

(7.2

)

 

15.5

 

 

13.5

 

 

45.8

 

Income attributable to AECOM

 

88.1

 

 

83.9

 

 

15.4

 

 

224.4

 

 

216.2

 

Depreciation and amortization expense1

 

70.6

 

 

51.3

 

 

51.6

 

 

196.5

 

 

192.7

 

Interest income2

 

(3.0

)

 

(2.6

)

 

(0.8

)

 

(11.1

)

 

(10.4

)

Interest expense

 

40.2

 

 

34.9

 

 

47.5

 

 

161.6

 

 

159.8

 

Amortized bank fees included in interest expense

 

(3.4

)

 

(1.3

)

 

(1.6

)

 

(10.7

)

 

(6.2

)

EBITDA

 

192.5

 

 

166.2

 

 

112.1

 

 

560.7

 

 

552.1

 

Noncore operating losses & transaction related expenses

 

(1.2

)

 

 

 

 

 

4.5

 

 

5.6

 

Impairment of long-lived assets

 

24.9

 

 

 

 

 

 

24.9

 

 

 

Restructuring costs

 

16.2

 

 

20.3

 

 

91.9

 

 

95.4

 

 

188.4

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Depreciation expense included in above adjustments

 

(24.9

)

 

 

 

 

 

(24.9

)

 

 

Adjusted EBITDA

 

203.9

 

 

186.5

 

 

204.0

 

 

657.0

 

 

746.1

 

Other income

 

(3.5

)

 

(3.1

)

 

(1.5

)

 

(14.7

)

 

(11.0

)

Depreciation expense1

 

(36.3

)

 

(32.8

)

 

(37.6

)

 

(136.4

)

 

(133.5

)

Interest income2

 

3.0

 

 

2.6

 

 

0.8

 

 

11.2

 

 

10.4

 

Noncontrolling interest in income of consolidated subsidiaries, net of tax

 

6.8

 

 

3.1

 

 

4.0

 

 

24.9

 

 

16.5

 

Amortization of intangible assets included in NCI

 

0.2

 

 

0.1

 

 

0.2

 

 

0.5

 

 

0.4

 

Adjusted income from operations

$

174.1

 

$

156.4

 

$

169.9

 

$

542.5

 

$

628.9

 

____________________

1 Excludes depreciation from noncore operating losses and accelerated depreciation of project management tool 2 Included in other income

Note: Variances within tables are due to rounding.

AECOM

Regulation G Information

(in millions, except per share data)

 

Three Months Ended

 

Twelve Months Ended

 

 

Sep 30,

2019

 

 

Jun 30,

2020

 

Sep 30,

2020

 

Sep 30,

2019

 

 

Sep 30,

2020

 

Reconciliation of Segment Income from Operations to Adjusted Income from Operations

Americas Segment:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income from operations

$

148.7

 

$

160.8

 

$

152.6

 

$

518.4

 

$

600.3

 

Noncore operating losses & transaction related expenses

 

(0.9

)

 

 

 

 

 

6.6

 

 

 

Impairment of long-lived assets

 

10.8

 

 

 

 

 

 

10.8

 

 

 

Amortization of intangible assets

 

4.8

 

 

4.5

 

 

4.4

 

 

19.2

 

 

18.4

 

Adjusted income from operations

$

163.4

 

$

165.3

 

$

157.0

 

$

555.0

 

$

618.7

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

International Segment:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income from operations

$

35.0

 

$

32.3

 

$

39.7

 

$

105.0

 

$

136.5

 

Noncore operating losses & transaction related expenses

 

(0.3

)

 

 

 

 

 

(2.1

)

 

(0.1

)

Impairment of long-lived assets

 

4.4

 

 

 

 

 

 

4.4

 

 

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Amortization of intangible assets

 

1.4

 

 

1.4

 

 

1.4

 

 

6.0

 

 

5.6

 

Adjusted income from operations

$

36.9

 

$

33.7

 

$

41.1

 

$

109.7

 

$

142.0

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Segment Performance (excludes ACAP):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Income from operations

$

183.7

 

$

193.1

 

$

192.3

 

$

623.4

 

$

736.8

 

Noncore operating losses & transaction related expenses

 

(1.2

)

 

 

 

 

 

4.5

 

 

(0.1

)

Impairment of long-lived assets

 

15.2

 

 

 

 

 

 

15.2

 

 

 

Gain on disposal activities

 

(3.6

)

 

 

 

 

 

(3.6

)

 

 

Amortization of intangible assets

 

6.2

 

 

5.9

 

 

5.8

 

 

25.2

 

 

24.0

 

Adjusted income from operations

$

200.3

 

$

199.0

 

$

198.1

 

$

664.7

 

$

760.7

 

 

Note: Variances within tables are due to rounding.

AECOM

Regulation G Information

Reconciliation of FY21 GAAP EPS Guidance based on Adjusted EPS Guidance

(all figures approximate)

Fiscal Year End 2021

 

 

 

 

GAAP EPS Guidance

 

$2.25 to $2.45

 

Adjusted EPS Excludes:

 

 

 

Amortization of intangible assets

 

$0.13

 

Amortization of deferred financing fees

 

$0.03

 

Restructuring

 

$0.26

 

Tax effect of the above items

 

($0.12)

 

Adjusted EPS Guidance

 

$2.55 to $2.75

 

Reconciliation of FY21 GAAP Net Income Attributable to AECOM from Continuing Operations Guidance based on Adjusted EBITDA Guidance

(in millions, all figures approximate)

Fiscal Year End 2021

 

 

 

GAAP net income attributable to AECOM from continuing operations guidance*

$344 to $375

Adjusted net income attributable to AECOM from continuing operations excludes:

 

Amortization of intangible assets

$20

Amortization of deferred financing fees

$5

Restructuring*

$40

Tax effect of the above items

($19)

Adjusted net income attributable to AECOM from continuing operations

$390 to $421

Adjusted EBITDA excludes:

 

Adjusted interest expense, net

$112

Depreciation

$132

Income tax expense

$156 to $165

Adjusted EBITDA Guidance

$790 to $830

____________________

*Calculated based on the mid-point of AECOM’s fiscal year 2021 guidance.

Reconciliation of FY21 GAAP Interest Expense Guidance based on Adjusted Interest Expense Guidance

(in millions, all figures approximate)

Fiscal Year End 2021

 

 

 

 

GAAP Interest Expense Guidance

 

$121

 

Financing charges in interest expense

 

($5)

 

Interest income

 

($4)

 

Adjusted Interest Expense Guidance

 

$112

 

 

Reconciliation of FY21 Operating Cash Flow Guidance based on Free Cash Flow Guidance

(in millions, all figures approximate)

Fiscal Year End 2021

 

 

 

 

Operating Cash Flow Guidance

 

$535 to $735

 

Capital expenditures, net of proceeds from disposals

($110)

 

Free Cash Flow Guidance

 

$425 to $625

 

 

Reconciliation of Income from Operations as a % of Revenue to Segment Adjusted Operating Income as a % of Net Service Revenue

 

Fiscal Year End 2021

 

 

 

 

Income from operations as a % of revenue

 

4.7%

 

ACAP income from operations

 

(0.1%)

 

Corporate net expenses

 

1.1%

 

Restructuring expenses

 

0.3%

 

Subcontractor and other direct costs

 

7.0%

 

Amortization of intangibles assets

 

0.2%

 

Segment adjusted operating income as a % of net service revenue

 

 

 

13.2%

 

 

____________________

Note: Variances within tables are due to rounding.

 

Investor Contact:

Will Gabrielski

Senior Vice President, Finance, Investor Relations

213.593.8208

[email protected]

Media Contact:

Brendan Ranson-Walsh

Vice President, Global Communications & Corporate Responsibility

213.996.2367

[email protected]

KEYWORDS: California United States North America Canada

INDUSTRY KEYWORDS: Other Manufacturing Commercial Building & Real Estate Construction & Property Consulting Engineering Professional Services Manufacturing Other Construction & Property Residential Building & Real Estate Other Professional Services

MEDIA:

Acasti Pharma Provides Business Update for the Second Quarter of Fiscal 2021

LAVAL, Quebec, Nov. 16, 2020 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST) today provided a business update and announced its operating and financial results for the second quarter of fiscal 2021 ended September 30, 2020.

Recent Events
:

TRILOGY 1 & 2 Topline Results
. The Company’s two Phase 3 clinical trials, designated as TRILOGY 1 & 2, were designed to evaluate the efficacy, safety and tolerability of CaPre in patients with severe hypertriglyceridemia. The top-line results were announced on January 13, 2020 and August 31, 2020 respectively, and neither TRILOGY 1 nor TRILOGY 2 independently reached statistical significance, and therefore they did not meet their primary endpoint for lowering triglycerides. Although the triglyceride reduction in the CaPre arm was one of the largest seen amongst previously conducted triglyceride reduction studies, the Company will not file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for patients with severe hypertriglyceridemia and does not plan to conduct additional clinical trials for CaPre.

Engaged Oppenheimer & Co. Inc
.
to Assist in Strategic Review. On September 29, 2020, the Company announced that it had engaged Oppenheimer & Co. Inc. as its financial advisor to assist in the strategic review process. Potential strategic alternatives that may be explored or evaluated as part of this review include, but are not limited to, a merger, business combination or other strategic transaction involving Acasti and/or CaPre. There is no defined timeline for completion of the review process.

Reduction in Headcount and Discontinuation of Substantially all
Commercial and
R&D Activities. The Company initiated a plan in September 2020 to reduce personnel and expenses to preserve cash and further reduce its operations consistent with the decision to discontinue substantially all commercialization and research and development activities. The Company expects to devote significant time and resources to identifying and evaluating strategic alternatives, however, there can be no assurance that such activities will result in any agreements or transactions that will enhance shareholder value.

Jan D’Alvise, Chief Executive Officer of Acasti, commented, “We remain committed to maximizing value for our shareholders, and as previously disclosed, we are actively exploring and evaluating a range of strategic options. We have also taken a number of proactive steps to preserve our cash by reducing staff, discontinuing all commercialization activities and putting R&D activities on hold. This has resulted in certain one-time and non-cash charges as reflected in our financial statements this quarter. While we continue to pursue strategic alternatives, we plan to complete the full data analyses for TRILOGY as contemplated in the Statistical Analysis Plan, including the pooling of the data from TRILOGY 1 and 2. As previously disclosed, we plan to provide an update on the final TRILOGY data when feasible.”

Second
Quarter of Fiscal 2021
Financial Results
(US dollars):

The consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”).

  • Loss from operat
    ions for the three months September 30, 2020 was $7.8 million, compared to a loss from operations of $6.3 million for the three months ended September 30, 2019. The increase was due mainly to impairment charges of $5.3 million, $3.7 million related to intangible assets and $1.6 million related to production and lab equipment, offset by a reduction in R&D, general and administrative expenses, and sales and marketing expenses.
  • Net loss for the three months ended September 30, 2020 was $6.1 million or $0.06 per share, compared to a net loss of $21.2 million or $0.25 per share for the three months ended September 30, 2019. The reduction in net loss, resulted primarily from net financial expenses decreasing to a gain of $1.9 million for the three months ended September 30, 2020, as compared to net financial expenses of $14.9 million for the three months ended September 30, 2019. This is due mostly to a decreased impact from the change in fair value of the derivative warrant liability as compared to the comparative fiscal quarter in 2019, caused by a proportionately higher decrease in the quarter over quarter closing share price partly offset by a reduction in the number of warrants outstanding due to exercises during the prior year.
  • R&D expense
    s before depreciation, amortization and stock-based compensation expenses were $0.8 million for the three months ended September 30, 2020, compared to $3.3 million for the three months ended September 30, 2019. The net decrease was mainly attributable to a reduction in salaries and research contracts with the reduction in R&D activities.
  • General and Administrative expenses before stock-based compensation expenses were $1.1 million for the three months ended September 30, 2020, compared to $1.1 million for the three months ended September 30, 2019. This reflects a $0.27 million increase related to legal fees related offset by a decrease of $0.23 million related to salaries, due to a reversal of bonus accruals.
  • Sales and Marketing expenses before stock-based compensation expenses were $0.02 million for the three months ended September 30, 2020, compared to $0.66 million for the three months ended September 30, 2019. The decrease was mostly due to a reduction in professional fees as a result of a reclassification of professional and other expenses to R&D.
  • Cash flows Cash and cash equivalents totaled $11.6 million as of September 30, 2020, compared to $14.2 million at March 31, 2020. Acasti believes that existing cash will fully fund the Company’s operations through the second calendar quarter of 2021 or through to an eventual completion of the evaluation of strategic options, but there can be no assurance as to when or whether Acasti will complete any strategic transaction, collaboration or non-dilutive financings. If the Company cannot raise additional funds or find one or more strategic partners, it may not be able to realize its assets and discharge its liabilities in the normal course of business. As a result, there exists substantial doubt about the Company’s ability to continue as a going concern, and therefore, realize its assets and discharge its liabilities in the normal course of business.

NASDAQ
Minimum Bid Price Rule

On February 28, 2020, Acasti received written notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of $1.00 per share for the preceding 30 consecutive business days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price (the “Minimum Bid Price Rule”). Under NASDAQ Listing Rule 5810(c)(3)(A) – compliance period, Acasti initially had 180 calendar days to regain compliance.

On April 17, 2020, Acasti was informed that NASDAQ had granted temporary regulatory relief related to the Minimum Bid Price Rule due to the COVID-19 pandemic for all NASDAQ-listed companies and therefore extended the deadline for Acasti to regain compliance to November 9, 2020.

On November 11, 2020, Acasti was further informed that NASDAQ had granted an additional 180 calendar days, or until May 10, 2021, for Acasti to regain compliance with the Minimum Bid Price Rule.


Retention Agreements

In connection with its strategic review process, the Company also announces that, upon the recommendation of the Governance and Human Resources Committee of the board of directors, it has entered into retention incentive agreements with Ms. Jan D’Alvise, the Company’s President and Chief Executive Officer, and Mr. Pierre Lemieux, the Company’s Chief Operating Officer and Chief Scientific Officer (the “Retention Agreements”).

The Retention Agreements provide that the Company will pay Ms. D’Alvise an employment retention incentive of US $100,000 provided that she remains employed with the Company until the earlier of April 30, 2021 or the closing of a merger or like transaction with a third party.

In addition, the Retention Agreements also provide that the Company will pay each of Ms. D’Alvise and Mr. Lemieux an amount of up to US $125,000 in the event that certain milestones are met in relation to the monetization by the Company of its assets relating to the Company’s drug candidate, CaPre.

The Company also announces the upcoming departure of Mr. Brian Groch, its Chief Commercial Officer, from his position with the Company effective December 31, 2020, until which date he is continuing in his role with Acasti. The Company would like to thank Mr. Groch for his contributions to the Company and wishes him well in his future endeavors.

About Acasti

Acasti is a biopharmaceutical innovator that has historically focused on the research, development and commercialization of prescription drugs using OM3 fatty acids delivered both as free fatty acids and bound-to-phospholipid esters, derived from krill oil. OM3 fatty acids have extensive clinical evidence of safety and efficacy in lowering triglycerides in patients with hypertriglyceridemia, or HTG. CaPre, an OM3 phospholipid therapeutic, was being developed for patients with severe HTG.

F
o
rw
a
rd
L
oo
king
S
t
a
tem
e
n
ts

Statements in this press release that are not statements of historical or current fact constitute “forward-looking information” within the meaning of Canadian securities laws and “forward-looking statements” within the meaning of U.S. federal securities laws (collectively, “forward-looking statements”). Such forward-looking statements involve known and unknown risks, uncertainties, and other unknown factors that could cause the actual results of Acasti to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. In addition to statements which explicitly describe such risks and uncertainties, readers are urged to consider statements labeled with the terms “believes,” “belief,” “expects,” “intends,” “anticipates,” “potential,” “should,” “may,” “will,” “plans,” “continue”, “targeted”
or other similar expressions
to be uncertain and forward-looking. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Forward-looking statements in this press release include, but are not limited to, information or statements about
Acasti’s
strategy, future operations, prospects and the plans of management
;
the outcome of the
strategic
review process to explore and evaluate strategic alternatives to enhance shareholder value
; and
Acasti’s
ability to
successfully consummate a strategic transaction
.

The forward-looking statements contained in this press release are expressly qualified in their entirety by this cautionary statement, the “
Special
Note Regarding Forward-Looking
Statements
” section contained in
Acasti’s
latest annual report on Form
10-K
and quarterly report on Form 10-Q
,
which
are
available on
EDGAR at

www.sec.gov/edgar/shtml

, on
SEDAR at www.sedar.com and on the investor section of
Acasti’s
website at www.acastipharma.com. All forward-looking statements in this press release are made as of the date of this press release. Acasti does not undertake to update any such forward-looking statements whether
as a result of
new information, future events or otherwise, except as required by law. The forward-looking
statements contained herein are also subject generally to assumptions and risks and uncertainties that are described from time to time in
Acasti’s
public securities filings with the Securities and Exchange Commission and the Canadian securities commissions, including
Acasti’s
latest annual report on Form
10-K
and quarterly report on Form 10-Q
under the caption “Risk Factors”
.

Neither NASDAQ, the 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.

A
c
a
s
t
i
C
on
t
a
c
t:

Jan D’Alvise
Chief Executive Officer
Tel: 450-686-4555
Email: info@acastipharma.com
www.acastipharma.com

Investor
C
on
t
a
c
t:

Crescendo Communications, LLC
Tel: 212-671-1020
Email: [email protected]



Silvercorp Intersects 1.89 Metres Grading 37.08 Grams Per Tonne Gold in New Gold Zones at the LMW Mine, Ying Mining District, China

VANCOUVER, British Columbia, Nov. 16, 2020 (GLOBE NEWSWIRE) — Silvercorp Metals Inc. (“Silvercorp” or the “Company”) (TSX/NYSE American: SVM) is pleased to report the discovery of new gold zones and high grade intercepts from its 2020 exploration program at the LMW mine, Ying Mining District, Henan Province, China. Extensive exploration drilling and tunnelling are ongoing at the LMW mine, and all other mines at the Ying Mining District.

The 2020 exploration program from July 1, 2019 to October 30, 2020 at the LMW mine has used in-fill drilling to target areas of known sub-vertical silver-lead-zinc veins that were previously believed to be uneconomic. Since June 2020, drilling has also targeted the gently-dipping zones believed to host gold mineralization, as reported in the May 28, 2020 news release. These gold zones were previously undiscovered and appear to have been over-printed by the sub-vertical silver-lead-zinc veins which are the focus of current mining operations.   Currently, ten rigs are drilling at the LMW mine and a total of 132 diamond drill holes, including 108 underground holes and 24 surface holes totaling 37,869 metres (“m”) have been completed. Assay results for 125 holes have been received with 72 holes intercepting many zones of higher-grade silver-lead mineralization, including veins LM7, LM7W1, LM8, LM8_1, LM12_1, LM13, LM14, LM16, LM22, LM25W, LM41E, LM41E1, and LM41E2. Most of these higher-grade silver-lead discoveries can be mined through existing tunnels which is expected to substantially reduce tunnel development costs at the LMW mine going forward.

Drilling to test the gold-bearing sub-horizontal shear zone LM22 has intersected high gold grades, including 37.08 g/t Au over 1.89m. In addition, at least three new gently-dipping (to the west at less than 15°), stacked gold mineralization zones, namely LM50, LM51 and LM53, have been discovered in this drill campaign. The gold mineralization is associated with k-feldspar-ankerite-quartz-pyrite-galena veinlets and stockwork alteration. The most-drilled LM50 vein has been defined by drilling and underground tunnelling over 450m along strike to the northeast and 350m down-dip in a 25m to 50m grid pattern and true thicknesses ranging from 0.5m to over 5.4m. Three rigs are drilling LM50 which is open in all directions.

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/9b26bc88-10c9-403e-a77f-76bdbb51a4ce

Highlights of selected drill hole intersections:

  • Hole
    ZKX0535 intersected a 1.89m interval (1.66m true width) of vein LM22 grading 37.08 grams per tonne (“g/t”) gold (“Au”), 4 g/t silver (“Ag”), and 0.53% copper (“Cu”), which includes a 1.25m interval (1.10m true width) grading 55.80 g/t Au, 5 g/t Ag, and 0.56% Cu.
  • Hole
    ZKX0723 intersected a 6.13m interval (4.89m true width) of vein LM50 grading 5.23 g/t Au, 30 g/t Ag, 0.21% lead (“Pb”), and 0.12% zinc (“Zn”), which includes a 1.58m interval (1.34m true width) grading 12.70 g/t Au, 19 g/t Ag, 0.10% Pb, and 0.12% Zn.
  • Hole ZKX0527 intersected a 2.34m interval (2.22m true width) of vein LM50 grading 8.51 g/t Au, and 16 g/t Ag, including a 1.22m interval (1.16m true width) grading 13.30 g/t Au, and 15 g/t Ag.
  • Hole ZKX0725 intercepted a 2.45m interval grading 4.33 g/t Au of an unknown vein, approximately 50m above the LM50 zone.
  • Hole
    ZKX0940 intersected a 1.63m interval (1.46m true width) of vein LM8_1 grading 1,984 g/t Ag, 3.86% Pb, 0.60% Zn, 0.07 g/t Au, and 0.49% Cu, which includes a 1.08m interval (0.97m true width) grading 2,985 g/t Ag, 5.26% Pb, 0.87% Zn, 0.10 g/t Au, and 0.73% Cu.
  • Hole
    ZKX0934 intersected a 4.43m interval (2.50m true width) of vein LM12_1 grading 343 g/t Ag, 6.21% Pb, 1.16% Zn, and 0.17 g/t Au, which includes two intersections:

    • A 1.24m interval (0.70m true width) grading 339 g/t Ag, 7.72% Pb, 0.28% Zn, and 0.17 g/t Au; and
    • A 0.89m interval (0.50m true width) grading 1,185 g/t Ag, 17.46% Pb, 4.84% Zn, and 0.50 g/t Au.
  • Hole ZKX0118 intersected a 1.81m interval (1.29m true width) of vein LM25W grading 1,715 g/t Ag, 1.53% Pb, 0.44% Zn, 0.44 g/t Au, and 0.30% Cu.

In addition, a total of 8,684m of exploration tunnels have been developed at the LMW mine during the period. These exploration tunnels (including 4,750m of drifts) were driven along and across major mineralized vein structures to upgrade the drill defined mineral resources and test for new parallel and splay structures, and are summarized in the following table:

Major Target Veins

Total

Tunne
l
ling

(m)

Channel
Samples
Collected

Drift

Included

(m)

Total Mineralization Exposed by Drifts

[1]
Length

(m)
Average
True Width


m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
LM19W2, T27E, LM14,
LM16_1, LM16,LM17W,
LM12_1, LM12E, LM22,
LM8_4a, LM32, LM8, LM41E,
LM17
8,684 3,320 4,750 775 0.53 397 4.34 0.42 0.09 0.18

[1] Mineralization is defined by silver equivalent value (AgEq) greater than or equal to 155 g/t at the LMW mine (Formula used for AgEq calculation: AgEq = Ag g/t + 35.06 * (Pb% + Cu%) + 79.57 * Au g/t).

Highlights of selected mineralized zones exposed in the drift tunnels:

  • Drift Tunnel
    XPDS-LM17-575-26SYM2 exposed mineralization 25m long and 1.54m wide (true width) grading 894 g/t Ag, 9.35% Pb, 0.53% Zn, 0.17 g/t Au, and 1.16% Cu within vein structure LM17;
  • Drift Tunnel
    XPDS-LM16-675-115SYM exposed mineralization 10m long and 0.59m wide (true width) grading 1,740 g/t Ag, 0.96% Pb and 0.36% Zn within vein structure LM16;
  • Drift Tunnel
    PD1080-LM41E-1080-11NYM exposed mineralization 15m long and 0.74m wide (true width) grading 1,079 g/t Ag, 2.12% Pb, 0.15% Zn, 0.02 g/t Au, and 0.55% Cu within vein structure LM41E; and
  • Drift Tunnel
    PD918-W6-880-128NYM exposed mineralization 35m long and 0.68m wide (true width) grading 603 g/t Ag, 4.91% Pb, 2.12% Zn, 0.02 g/t Au, and 0.13% Cu within vein structure W6.



Table
1
:
Selected
results from the 2020 drill programs at the LMW mine

Hole ID From

(m)
To

(m)
Interval

(m)
True Width

(m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
Vein Ore Type
ZKX0015 307.53 308.73 1.20 1.07 331 1.10 2.78 0.05 0.14 LM10W Ag-Pb
ZKX0015 349.68 350.51 0.83 0.78 3 0.01 0.01 1.03 0.29 LM51 [1] Au
ZKX0016 131.45 133.12 1.67 0.94 522 0.43 0.03 0.05 0.07 LM13 Ag-Pb
ZKX0017 278.50 280.97 2.47 1.34 273 0.25 0.03 0.16 0.26 LM26 [1] Au
ZKX0026 192.99 193.79 0.80 0.75 13 0.02 0.02 4.75 2.18 LM26 Au
ZKX0118 30.48 32.29 1.81 1.29 1,715 1.53 0.44 0.44 0.30 LM25W Ag-Pb
ZKX0118 146.71 148.17 1.46 1.27 3 0.01 0.01 3.52 0.33 LM22 [1] Au
ZKX0319 270.45 271.16 0.71 0.57 5 0.01 0.01 3.19 0.69 LM51 Au
ZKX0334 84.70 86.08 1.38 1.30 1 0.00 0.00 5.43 0.09 LM22 Au
ZKX0517 46.70 47.23 0.53 0.50 6 0.01 0.02 2.49 0.00 LM22a [1] Au
ZKX0527 162.82 165.16 2.34 2.22 16 0.64 0.07 8.51 0.01 LM50 [1] Au
Including 163.94 165.16 1.22 1.16 15 0.86 0.07 13.30 0.01 LM50 Au
ZKX0528 154.89 159.55 4.66 3.15 5 0.01 0.02 2.58 0.00 LM50 Au
Including 159.15 159.55 0.40 0.26 47 0.04 0.04 26.70 0.01 LM50 Au
ZKX0529 113.56 114.16 0.60 0.36 780 1.23 0.33 0.04 0.46 LM7W1 Ag-Pb
ZKX0529 168.28 176.06 7.78 4.68 256 0.76 0.07 0.01 0.08 LM7 Ag-Pb
Including 168.28 169.97 1.69 1.02 587 0.25 0.02 0.01 0.03 LM7 Ag-Pb
and 174.68 176.06 1.38 0.83 609 2.93 0.24 0.01 0.39 LM7 Ag-Pb
ZKX0531 105.26 105.97 0.71 0.61 5 0.02 0.01 21.10 1.14 LM22 Au
ZKX0535 92.91 94.80 1.89 1.66 4 0.00 0.01 37.08 0.53 LM22 Au
Including 92.91 94.16 1.25 1.10 5 0.00 0.01 55.80 0.56 LM22 Au
ZKX0723 184.27 190.40 6.13 4.89 30 0.21 0.12 5.23 0.00 LM50 Au
Including 184.27 185.85 1.58 1.34 19 0.10 0.12 12.70 0.01 LM50 Au
ZKX0725 126.41 128.86 2.45 2.06 2 0.01 0.01 4.33 0.01 ? [1], [2] Au
Including 126.41 127.36 0.95 0.80 3 0.02 0.01 10.03 0.01 ? Au
ZKX0725 166.07 167.37 1.30 1.18 1 0.02 0.06 1.87 0.01 LM50 Au
ZKX0726 165.59 166.44 0.85 0.65 15 0.59 0.33 9.74 0.01 LM50 Au
ZKX0726 207.06 208.56 1.50 0.92 370 0.59 0.08 0.01 0.04 LM8a Ag-Pb
ZKX0934 135.46 136.56 1.10 0.98 39 0.09 0.46 3.25 0.01 LM13 Ag-Pb
ZKX0934 323.27 327.70 4.43 2.50 343 6.21 1.16 0.17 0.04 LM12_1 Ag-Pb
Including 323.27 324.51 1.24 0.70 339 7.72 0.28 0.17 0.05 LM12_1 Ag-Pb
and 326.81 327.70 0.89 0.50 1,185 17.64 4.84 0.50 0.08 LM12_1 Ag-Pb
ZKX0940 249.22 250.85 1.63 1.46 1,984 3.86 0.60 0.07 0.49 LM8_1 Ag-Pb
Including 249.77 250.85 1.08 0.97 2,985 5.26 0.87 0.10 0.73 LM8_1 Ag-Pb
ZKX1103 56.48 57.34 0.86 0.72 156 0.91 0.05 0.03 0.01 LM7W1 Ag-Pb
ZKX1103 116.00 116.29 0.29 0.27 618 0.08 0.03 0.03 0.04 LM7W Ag-Pb
ZKX1104 157.45 157.70 0.25 0.23 2,133 1.99 0.14 0.05 0.18 LM41E Ag-Pb
ZKX1105 130.58 131.30 0.72 0.62 644 3.02 0.79 0.05 0.33 LM41E2 Ag-Pb
Including 130.58 130.82 0.24 0.21 1,842 8.37 2.25 0.05 0.94 LM41E2 Ag-Pb
ZKX1105 133.32 133.69 0.37 0.32 582 3.69 1.07 0.05 0.22 LM41E1 Ag-Pb
ZKX1108 130.04 131.52 1.48 0.85 330 0.63 0.02 0.01 0.02 LM12E Ag-Pb
ZKX1109 157.87 158.85 0.98 0.51 12 0.04 0.03 8.35 0.00 LM50 Au
ZKX1501 270.21 273.89 3.68 2.83 135 0.35 0.04 0.01 0.02 T22 Ag-Pb
Including 270.21 270.46 0.25 0.16 1,579 3.70 0.40 0.03 0.20 T22 Ag-Pb
ZKX4007 284.81 287.36 2.55 1.81 423 0.26 0.22 0.01 0.07 LM17 Ag-Pb
ZKX4008 296.43 297.54 1.11 0.80 29 13.52 0.04 0.01 0.00 LM17 Ag-Pb
Including 297.21 297.54 0.33 0.24 81 43.66 0.03 0.02 0.01 LM17 Ag-Pb
ZKX6801 121.67 122.94 1.27 1.22 2 0.25 0.02 1.99 0.02 LM53 [1] Au
Including 122.68 122.94 0.26 0.25 6 0.91 0.03 5.91 0.04 LM53 Au
ZKX6803 182.76 184.49 1.73 0.89 454 1.37 0.18 0.01 0.28 ? Ag-Pb
ZKX10105 336.91 337.16 0.25 0.20 20 9.13 1.00 0.03 0 LM8W Ag-Pb
ZKX10509 254.09 254.52 0.43 0.40 743 0.32 0.30 0.31 0.05 LM8W3 Ag-Pb
ZKX10509 282.06 282.41 0.35 0.27 723 1.57 0.14 0.33 0.01 LM8W2 Ag-Pb
ZKX10509 385.00 385.51 0.51 0.39 168 11.57 1.77 0.22 0.03 LM8 Ag-Pb
ZKX10708 247.43 249.99 2.56 2.15 394 2.96 0.22 0.03 0.07 LM8 Ag-Pb
ZKX10814 232.25 233.17 0.92 0.65 9 0.02 0.01 2.21 0.00 LM51 Au
ZKX10915 8.72 9.19 0.47 0.36 639 3.04 0.36 0.12 0.02 LM20 Ag-Pb
ZKX11402 259.04 259.84 0.80 0.54 527 2.21 0.43 0.07 0.12 LM8 Ag-Pb
ZKX11507 229.68 231.39 1.71 0.93 82 7.53 0.13 0.01 0.04 LM17W Ag-Pb
ZKX12503 174.73 175.88 1.15 0.99 475 1.68 0.13 0.05 0.02 LM14 Ag-Pb
ZKT4402 174.17 174.95 0.78 0.66 18 0.17 0.01 8.60 0.29 ? Au
ZKT4802 318.39 319.08 0.69 0.64 366 7.85 0.42 0.05 0.02 T11 Ag-Pb
Including 318.39 318.62 0.23 0.21 329 22.97 1.15 0.05 0.03 T11 Ag-Pb

[1] Veins discovered between July 1, 2019 and October 30, 2020.

[2] New veins with no name assigned.

Table
2
:
Selected
mineralized zones exposed by drift
tun
n
el
li
ng
at
the LM
W
mine

Tunnel ID Vein Ore
Length


(m)
True
Width


(m)
Ag

(g/t)
Pb

(%)
Zn

(%)
Au

(g/t)
Cu

(%)
XPDN-LM8-600-111NYM LM8 25 0.33 229 2.57 0.29 0.04 0.07
XPDN-LM8_4a-500-143NYM LM8_4a 35 0.42 301 1.07 1.39 0.00 0.00
PD969Shaft-LM12_1-600-12SYM LM12_1 45 0.77 344 3.37 0.19 0.00 0.00
PD924-LM12E-924-11NYM LM12E 35 0.46 201 1.33 0.15 0.00 0.00
XPDS-LM14-625-109SYM LM14 20 0.24 440 3.34 0.06 0.00 0.00
XPDS-LM14-575-113NYM1 LM14 15 0.47 135 3.58 0.19 0.00 0.00
XPDS-LM14-575-113NYM2 LM14 15 0.30 304 2.96 0.25 0.00 0.00
XPDS-LM16-675-115SYM LM16 10 0.59 1,740 0.96 0.36 0.00 0.00
XPDS-LM16_1-725-111NYM LM16_1 20 0.29 616 1.64 0.25 0.00 0.00
XPDS-LM17-575-26SYM1 LM17 40 0.70 96 4.02 0.35 0.00 0.00
XPDS-LM17-575-26SYM2 LM17 25 1.54 894 9.35 0.53 0.17 1.16
XPDS-LM17W-600-0NYM1 LM17W 20 0.40 377 4.37 0.66 0.00 0.00
XPDS-LM17W-600-0NYM2 LM17W 40 0.72 249 2.98 1.16 0.00 0.00
XPDN-LM17W-800-9ECM LM17W1 15 0.27 719 5.07 0.59 0.00 0.00
XPDN-LM19W2-700-122SYM LM19W2 70 0.63 499 2.72 0.45 0.00 0.00
PD969Shaft-LM19W2-600-114SYM LM19W2 12 0.52 195 1.22 0.18 0.00 0.00
PD969Shaft-LM19W2-600-114NYM LM19W2 15 0.56 381 1.63 0.15 0.00 0.00
SJ969-LM19W2-550-110NYM LM19W2 15 0.97 26 8.58 0.26 0.00 0.00
PD924-LM22-834-3NYM LM22 40 0.18 11 0.04 0.01 2.72 1.55
PD969Shaft-LM30-550-114SYM LM30 30 0.41 136 4.40 0.31 0.00 0.00
PD969Shaft-LM12_2-500-14SYM LM32 25 0.28 303 4.87 0.85 0.33 0.11
PD1080-LM41E-1080-11NYM LM41E 15 0.74 1,079 2.12 0.15 0.02 0.55
PD924-T27E-900-110SYM T27E 20 0.89 114 14.33 0.17 0.00 0.00
PD918-W6-880-128NYM W6 [1] 35 0.68 603 4.91 2.12 0.02 0.13

[1] Veins discovered between July 1, 2019 and October 30, 2020.

Quality Control

Drill cores are NQ size. Drill core samples, limited by apparent mineralization contacts or shear/alteration contacts, were split into halves by saw cutting. The half cores are stored in the Company’s core shacks for future reference and checks, and the other half core samples are shipped in securely sealed bags to the Chengde Huakan 514 Geology and Minerals Test and Research Institute in Chengde, Hebei Province, China, 226km northeast of Beijing, the Zhengzhou Nonferrous Exploration Institute Lab in Zhengzhou, Henan Province, China, and SGS-CSTC Standards Technical Services (Tianjin) Co., Ltd., Tianjin, China. All the three labs are ISO9000 certified analytical labs. For analysis, the sample is dried and crushed to minus 1mm and then split to a 200-300g subsample which is further pulverized to minus 200 mesh. Two subsamples are prepared from the pulverized sample. One is digested with aqua regia for gold analysis with atomic absorption spectroscopy (AAS), and the other is digested with two-acids for analysis of silver, lead, zinc and copper with AAS.

Channel samples are collected along sample lines perpendicular to the mineralized vein structure in exploration tunnels. Spacing between sampling lines is typically 5m along strike. Both the mineralized vein and the altered wall rocks are cut by continuous chisel chipping. Sample length ranges from 0.2m to more than 1.0m, depending on the width of the mineralized vein and the mineralization type. Channel samples are prepared and assayed with AAS at Silvercorp’s mine laboratory (Ying Lab) located at the mill complex in Luoning County, Henan Province, China. The Ying lab is officially accredited by the Quality and Technology Monitoring Bureau of Henan Province and is qualified to provide analytical services. The channel samples are dried, crushed and pulverized. A 200g sample of minus 160 mesh is prepared for assay. A duplicate sample of minus 1mm is made and kept in the laboratory archives. Gold is analysed by fire assay with AAS finish, and silver, lead, zinc and copper are assayed by two-acid digestion with AAS finish.

A routine quality assurance/quality control (QA/QC) procedure is adopted to monitor the analytical quality at each lab. Certified reference materials (CRMs), pulp duplicates and blanks are inserted into each batch of lab samples. QA/QC data at the lab are attached to the assay certificates for each batch of samples.

The Company maintains its own comprehensive QA/QC program to ensure best practices in sample preparation and analysis of the exploration samples. Project geologists regularly insert CRM, field duplicates and blanks to each batch of 30 core samples to monitor the sample preparation and analysis procedures at the labs. The analytical quality of the labs is further evaluated with external checks by sending approximately 3-5% of the pulp samples to higher level labs to check for lab bias. Data from both the Company’s and the labs’ QA/QC programs are reviewed on a timely basis by project geologists.

Guoliang Ma, P. Geo., Manager of Exploration and Resource of the Company, is the Qualified Person for Silvercorp under NI 43-101 and has reviewed and given consent to the technical information contained in this news release.

About Silvercorp

Silvercorp is a profitable Canadian mining company producing silver, lead and zinc metals in concentrates from mines in China. The Company’s goal is to continuously create healthy returns to shareholders through efficient management, organic growth and the acquisition of profitable projects. Silvercorp balances profitability, social and environmental relationships, employees’ wellbeing, and sustainable development. For more information, please visit our website at www.silvercorp.ca.

For further information

Lon Shaver
Vice President
Silvercorp Metals Inc.

Phone: (604) 669-9397
Toll Free: 1 (888) 224-1881
Email: [email protected]
Website: www.silvercorp.ca


CAUTIONARY DISCLAIMER – FORWARD LOOKING STATEMENTS

Certain of the statements and information in this news release constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of applicable Canadian provincial securities laws. Any statements or information that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, assumptions or future events or performance (often, but not always, using words or phrases such as “expects”, “is expected”, “anticipates”, “believes”, “plans”, “projects”, “estimates”, “assumes”, “intends”, “strategies”, “targets”, “goals”, “forecasts”, “objectives”, “budgets”, “schedules”, “potential” or variations thereof or stating that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved, or the negative of any of these terms and similar expressions) are not statements of historical fact and may be forward-looking statements or information. Forward-looking statements or information relate to, among other things: the price of silver and other metals; the accuracy of mineral resource and mineral reserve estimates at the Company’s material properties; the sufficiency of the Company’s capital to finance the Company’s operations; estimates of the Company’s revenues and capital expenditures; estimated production from the Company’s mines in the Ying Mining District; timing of receipt of permits and regulatory approvals; availability of funds from production to finance the Company’s operations; and
access to and availability of funding for future construction, use of proceeds from any financing and development of the Company’s properties.

Forward-looking statements or information are subject to a variety of known and unknown risks, uncertainties and other factors that could cause actual events or results to differ from those reflected in the forward-looking statements or information, including, without limitation, social and economic impacts of COVID-19; risks relating to: fluctuating commodity prices; calculation of resources, reserves and mineralization and precious and base metal recovery; interpretations and assumptions of mineral resource and mineral reserve estimates; exploration and development programs; feasibility and engineering reports; permits and licenses; title to properties; property interests; joint venture partners; acquisition of commercially mineable mineral rights; financing; recent market events and conditions; economic factors affecting the Company; timing, estimated amount, capital and operating expenditures and economic returns of future production; integration of future acquisitions into the Company’s existing operations; competition; operations and political conditions; regulatory environment in China and Canada; environmental risks; foreign exchange rate fluctuations; insurance; risks and hazards of mining operations; key personnel; conflicts of interest; dependence on management; internal control over financial reporting as per the requirements of the Sarbanes-Oxley Act; and bringing actions and enforcing judgments under U.S. securities laws.

This list is not exhaustive of the factors that may affect any of the Company’s forward-looking statements or information. Forward-looking statements or information are statements about the future and are inherently uncertain, and actual achievements of the Company or other future events or conditions may differ materially from those reflected in the forward-looking statements or information due to a variety of risks, uncertainties and other factors, including, without limitation, those referred to in the Company’s Annual Information Form under the heading “Risk Factors”. Although the Company has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated, described or intended. Accordingly, readers should not place undue reliance on forward-looking statements or information.

The Company’s forward-looking statements and information are based on the assumptions, beliefs, expectations and opinions of management as of the date of this news release, and other than as required by applicable securities laws, the Company does not assume any obligation to update forward-looking statements and information if circumstances or management’s assumptions, beliefs, expectations or opinions should change, or changes in any other events affecting such statements or information. For the reasons set forth above, investors should not place undue reliance on forward-looking statements and information.


CAUTIONARY NOTE TO US INVESTORS

This news release has been prepared in accordance with the requirements of NI 43‐101 and the Canadian Institute of Mining, Metallurgy and Petroleum Definition Standards, which differ from the requirements of U.S. Securities laws. NI 43‐101 is a rule developed by the Canadian Securities Administrators that establishes standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects.

 



MATEON PROVIDES CORPORATE UPDATE AND ANNOUNCES THIRD QUARTER 2020 FINANCIAL RESULTS

AGOURA HILLS, Calif., Nov. 16, 2020 (GLOBE NEWSWIRE) — Mateon Therapeutics, Inc. (“Mateon” or the “Company”) (OTCQB: MATN) today announced financial results for the third quarter ended September 30, 2020 (“Q3 2020”), as well as an update on its therapeutic development initiatives, including those related to COVID-19.


Recent Operational Highlights

ArtiShield(outside of India)/ARTIVeda (India)
       
    o Signed an agreement with Windlas Biotech Pvt. Ltd. of India to commercialize ArtiShield/ARTIVeda, the Company’s lead ethnobiology dru,g designed to be a readily available and cost-effective agent to combat COVID-19;
    o ArtiShield/ARTIVeda approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy), license number UK.AY-401/2018, for the treatment of various symptoms like fever and inflammation frequently seen in COVID-19 patients;
    o Dr. Suhas Kshirsagar, B.A.M.S, M.D. (Ayurveda), a worldwide renowned ayurvedic expert, joined Mateon as an advisor for Mateon’s Ayurvedic product ARTIShield /ARTIVeda in its commercialization for COVID-19;
    o Dr. Suhas Kshirsagar led a successful symposium entitled: “Advancing Ayurveda Through Ethnobiology Drug Development.” Topics included Mateon’s ARTIShield/ ARTIVeda for the Treatment of COVID-19 and COVID-19/Influenza Coinfection. Presentations can be viewed at https://www.youtube.com/watch?v=0agiVypL_LU&feature=youtu.be.
    o Commenced patient enrollment for its ARTI-19 Phase IV multi-center interventional study to evaluate the safety and efficacy of ArtiShieldin the treatment of adults with COVID-19 in India. This global study will evaluate the safety and efficacy of ArtiShieldupto 3,000 total patients, 120 of whom are currently from India and further expandable to 300 patients from India. Top line data from ARTI-19 in India is expected between Q4 2020 and Q1 2021;
       
OT-101/COVID-19 program
       
    o Received clearance from regulatory authorities in Argentina and Peru to initiate a Phase II clinical trial of OT-101, a TGF-β antisense, for the treatment of patients with mild to severe COVID-19 infection. Top line data from the study is currently expected during or before Q1 2021. If the outcome is positive, the data will form the basis for Emergency Use Approval (EUA) application to global regulatory bodies. Including the US Food and Drug Administration (FDA);
       
    o Continuing our partnership with Golden Mountain Partners (GMP) and/or their designee with drawdown of the $2.0 M debt financial instrument with GMP to conduct OT-101/COVID-19 clinical trial.
       
Oxi4503/ Melanoma
       
    o Announced that the US FDA granted Rare Pediatric Disease (RPD) designation to OXi4503 (combretastatin A1-diphosphate; CA1P) for the treatment of acute myeloid leukemia due to genetic mutations that disproportionately affect pediatric patients. The FDA grants RPD designation for diseases with serious or life-threatening manifestations that primarily affect people aged from birth to 18 years, and that affect fewer than 200,000 people in the U.S.; and
       
Strengthened our scientific and management teams with the appointments of Anthony Maida, III, Ph.D., MA, MBA as Chief Clinical Officer – Translational Medicine to drive the Company’s clinical development activity.

“We are very encouraged by the progress being made at Mateon through the first nine months of 2020,” said Dr. Vuong Trieu, CEO of Mateon. “While our product portfolio addresses significant unmet needs with respect multiple disease states, including glioblastoma, melanoma, and pancreatic cancer, we are most excited by our strategy to focus on COVID-19 and COVID-19/influenza coinfection. We look forward to multiple clinical trial catalysts – notably top line data from our ARTI-19 Phase IV trial between Q4 2020 and Q2 2021 the end of this year – and are excited about the transformational opportunities that our therapies may provide.”

“We are excited about the commercialization of ARTIVeda in India. It is expected to be a cost-effective treatment and prophylactic for COVID-19. This is transformational for the Company, as we establish a consortium of manufacturers, distributors, and marketers for the equitable distribution of this COVID-19 therapy,” said Amit Shah, CFO of Mateon.


Q3 2020 Financial Results Overview –

MATEON THERAPEUTICS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED SEPTEMBER 30

(UNAUDITED)

    2020     2019     Variance  
Operating expense:                        
Research and development     936,196       343,789       592,407  
General and administrative     680,077       586,924       93,153  
Total operating expense     1,616,273       930,713       685,560  
Loss from operations     (1,616,273 )     (930,713 )     (685,560 )
Loss on conversion of debt     (88,817 )           (88,817 )
Change in the value of derivatives on debt     49,992             49,992  
Interest expense, net     (331,459 )     (60,413 )     (271,046 )
Net Loss   $ (1,986,557 )     (991,126 )     (995,431 )

Total operating expenses for Q3 2020 rose to $1.6 million from $0.9 million in Q3 2019, reflecting a $0.6 million increase in R&D expense and a $0.1 million increase in general & administrative expenses, both of which are to support ongoing clinical trial activity, including activity related to COVID-19.

Net loss attributable to common stockholders for Q3 2020 was $2.0 million, or ($0.02) per share, compared to a net loss of $1.0 million, or ($0.01) per share, for Q3 2019.

Cash and cash equivalents were $1.4 million as of September 30, 2020, compared to $0.6 million as of June 30, 2020, and $0.1 million as of December 31, 2019. Total assets increased from $23,684,781 to $24,628,545

“During Q3 2020 we raised proceeds of $2.3 million, net of costs, to help us advance our therapeutic development activities,” said Mr. Shah.“ Also, the Company has formally changed its name to Oncotelic Therapeutics, Inc. with the State of Delaware. We are working with the appropriate agencies to obtain approvals to change our name and establish our new ticker symbol.”

Additional information is included in the Company’s Form 10-Q for the period ended September 30, 2020, filed on November 16, 2020, a copy of which is available free of charge at http://investor.mateon.com/sec-filings.


ARTIShield ™/ARTIVedaTM- an Ethnobiology Drug

Mateon is pursuing several avenues with respect to the development and commercialization of ARTIShield in the treatment of COVID-19. ARTIShield is Ayurveda – Dvipaantara Damanaka – and is labeled as a capsule containing Artemisia Powder 500mg. It is a demonstration of how Ethnobiology can be used to drive drug development against emerging pandemics.

The classical pharmaceutical regulatory pathways have failed to provide fast-track to treatment and vaccines. Government resources have concentrated on a few candidates most of which have failed. The Ayurvedic medicine route is proving to be an accelerated pathway to deploy a well-known, abundantly available and cost effective Ayurvedic medicine that is safe and being proven in-vitro and large-scale clinical trial to be effective.


ARTIShield



/ARTIVeda



– Commercialization in India

Mateon announced that ARTIShield /ARTIVeda has been approved for manufacture and marketing by the Ministry of AYUSH (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) in India for the treatment of various symptoms including fever and inflammation, which can be associated with COVID-19. ARTIShield is in co-development with Windlas Biotech Pvt. Ltd., Mateon’s commercial partner for India and is designed to be a readily available and cost-effective agent to combat COVID-19. ARTIVeda is the tradename for India and ArtiShieldTM is the tradename for outside of India. Mateon expects sales will commence in India before year end.


ARTI-19 Multi-national Phase IV Trial, Currently in India

Mateon announced the enrollment of its first patient in a Phase IV study ARTI-19, “A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19”. This trial will compare the efficacy of oral doses with standard-of-care (SOC) versus SOC alone. This is a global study with India to contribute at least 300 patients to the total aggregate of 3000 patients. We expect preliminary top-line data for ARTI-19 sometime between Q420 and Q121.


About OT-101

OT-101 is an antisense against the host TGF-β protein required for viral replication and its overexpression likely to cause the wide range of clinical symptoms associated with COVID-19 including Kawasaki syndrome (Fatih M. Uckun, Vuong Trieu. Targeting Transforming Growth Factor-beta for Treatment of COVID-19-associated Kawasaki Disease in Children. Clin Res Pediatr 2020; 3(1): 1-3) and acute respiratory distress syndrome (ARDS) (Fatih M. Uckun, Larn Hwang, Vuong Trieu. Selectively targeting TGF-β with Trabedersen/OT-101 in treatment of evolving and mild ARDS in COVID-19. Clin. Invest. (Lond.) 2020; 10(2), 167-176. DOI: 10.4172/ Clinical-Investigation.1000166.).

TGF-β is elevated in COVID-19 (Xiong Y. et al. Transcriptomic characteristics of bronchoalveolar lavage fluid and peripheral blood mononuclear cells in COVID-19 patients. Emerging Microbes & infections 2020; 9:1, 761-770, DOI: 10.1080/22221751.2020.1747363. Agrati C. et al. Expansion of myeloid-derived suppressor cells in patients with severe coronavirus disease (COVID-19). Cell Death & Differentiation 2020; https://doi.org/10.1038/s41418-020-0572-6.).

OT-101 is also being developed as an adjuvant for second generation COVID-19 vaccine. To avoid the two potential issues with 1st generation vaccine against COVID-19, we will be combining the 1st generation COVID-19 DNA vaccine with a TGF-β inhibitor (OT-101) to stimulate a strong immune response while suppressing the IgA class switching that could aggravate the disease through Kawasaki reaction- IgA vasculitis. The company is aggressively pursuing the development of this 2nd generation COVID-19 vaccine expecting that the 1st generation vaccines would not be fully effective and may not be sufficiently protective to counter the current pandemic.

The development of OT-101 is important given the failure of other drugs leaving dexamethasone as the only clinically proven effective drug against COVID-19.


About Mateon Therapeutics

Mateon was created by the recent reverse merger with Oncotelic, which became a wholly owned subsidiary of Mateon, thereby creating an immuno-oncology company dedicated to the development of first in class RNA therapeutics as well as small molecule drugs against cancer and infectious diseases. OT-101, the lead immuno-oncology drug candidate of Mateon/Oncotelic, is a first-in-class anti-TGF-βRNA therapeutic that exhibited single agent activity in some relapsed/refractory cancer patients in clinical trial settings. OT-101 also has activity against SARS-CoV-2. Mateon/Oncotelic is seeking to leverage its deep expertise in oncology drug development to improve treatment outcomes and survival of cancer patients with a special emphasis on rare pediatric cancers. Mateon has rare pediatric designation for DIPG (OT-101), melanoma (CA4P), and AML (OXi4503).

For more information, please visit www.oncotelic.com and www.mateon.com.


Mateon’s Cautionary Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in this communication regarding strategy, future operations, future financial position, prospects, plans and objectives of management are forward-looking statements. Words such as “may”, “expect”, “anticipate” “hope”, “vision”, “optimism”, “design”, “exciting”, “promising”, “will”, “conviction”, “estimate,” “intend,” “believe”, “quest for a cure of cancer”, “innovation-driven”, “paradigm-shift”, “high scientific merit”, “impact potential” and similar expressions are intended to identify forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about future plans, the progress, timing, clinical development, scope and success of future clinical trials, the reporting of clinical data for the company’s product candidates and the potential use of the company’s product candidates to treat various cancer indications. Each of these forward-looking statements involves risks and uncertainties and actual results may differ materially from these forward-looking statements. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. These risks are not exhaustive, the company faces known and unknown risks, including the risk factors described in the company’s annual report on Form 10-K filed with the SEC on May 20, 2020 and in the company’s other periodic filings. Forward-looking statements are based on expectations and assumptions as of the date of this press release. Except as required by law, the company does not assume any obligation to update forward-looking statements contained herein to reflect any change in expectations, whether as a result of new information future events, or otherwise.

Contact Information:

For Mateon Therapeutics, Inc.:
Amit Shah
[email protected]



Nordic American Tankers Ltd (NYSE: NAT) – Report for the 3rd quarter – 2020 as a whole is expected to be a very good year for NAT

November 16, 2020

Dear Shareholders and Investors, 

Highlights: 


   

  1. The average Time Charter Equivalent (TCE) for our trading fleet during the third quarter was $25,000 per day per ship. In perspective, this is the best third quarter TCE result for many years.

  2. As 2020 draws to a close, we see far less uncertainty in the market place.

    Asia is recovering strongly, the US election season is over and a vaccine for Covid-19 may be widely available by early 2021. The global pandemic short term impacted the strong fundamentals we saw for the tanker market going into 2020. Despite a temporary slowdown, we see that 2020 as a whole will be a very good year for NAT. We believe that these positive fundamentals will continue.

  3. Cash dividends are a priority for NAT, and reflect our earnings. In 2020 we have paid $60 million or 41 cents per share in dividends. With this report we announce our 93rd consecutive quarterly dividend. The dividend for 3Q2020 is
    4 cents ($0.04) per share, payable on or about December 15, 2020, to shareholders of record December 2, 2020. The accumulated dividend payments for the last four quarters represent an annualized yield of 14% on today’s share price.

  4. During the third quarter we took several of our vessels through drydockings and as such our net voyage revenues and net profit were affected. This was an optimal timing. Our Net Income for 3Q 2020 thus came in at – $10.0 million, which gave an Earnings Per Share (EPS) of -$0.07. Our Year-to-date Net Income was positive with $78.7 million which is equivalent to an EPS of $0.53. This was an improvement of about $100 million compared to the same period in 2019, which produced a Net Income of -$23.1 million.

  5. Our EBITDA (non-GAAP measure) for 3Q2020 was positive by $15.6 million. This was lower than second quarter, but the EBITDA was an improvement compared to the same quarter last year, which generated an EBITDA of $11.5 million.

  6. Our total long term liabilities as per Sept 30, 2020 stood at $313.3 million, a reduction of more than $63 million since year-end 2019. Our Net Debt is $255.4 million or about $11 million per ship.
  1. On Sept 23, 2020 we announced two newbuilding contracts placed with Samsung Heavy Industries. The two suezmaxes will be delivered first half 2022. Financing has been secured. This is a part of our strategy to renew and grow our fleet. The quality of the NAT fleet is first rate, reflecting the vetting record of our ships.

  2. Detailed financial information for 3Q 2020 and for other periods is included later in this report.


 

Best regards,

Herbjorn Hansson

Founder, Chairman & CEO

 

Nordic American Tankers Ltd.                                                           www.nat.bm  


 


 


 


 


 

 
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “will,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, changes in demand in the tanker market, as a result of changes in OPEC’s petroleum production levels and worldwide oil consumption and storage, changes in our operating expenses, including bunker prices, drydocking and insurance costs, the market for our vessels, availability of financing and refinancing, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, vessels breakdowns and instances of off-hires and other important factors described from time to time in the reports filed by the Company with the Securities and Exchange Commission, including the prospectus and related prospectus supplement, our Annual Report on Form 20-F, and our reports on Form 6-K.

NAT is a Bermuda based company.

Contacts:       

Gary J. Wolfe
Seward & Kissel LLP
New York, USA
Tel: +1 212 574 1223

Bjørn Giæver, CFO
Nordic American Tankers Limited
Tel: +1 888 755 8391 or +47 91 35 00 91       

Herbjørn Hansson, Chairman & CEO
Nordic American Tankers Limited
Tel: +1 866 805 9504 or +47 90 14 62 91 

Attachment



Fluor and Sargent & Lundy Agree to Collaborate on New Carbon-Free Small Modular Nuclear Reactor Projects

Fluor and Sargent & Lundy Agree to Collaborate on New Carbon-Free Small Modular Nuclear Reactor Projects

IRVING, Texas–(BUSINESS WIRE)–Fluor Corporation (NYSE: FLR) announced today that the company has reached an agreement with Sargent & Lundy to collaborate with joint marketing and design services for the execution of new NuScale Power small modular nuclear reactor plants in North America.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201116005104/en/

Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

“Fluor has been a leader in serving the nuclear industry for more than 70 years including the design and construction support for more than 25 units, plus nearly 100 million hours of operations and maintenance work,” said Alan Boeckmann, Fluor’s executive chairman. “This collaboration agreement with one of the most respected companies serving the nuclear power industry brings nearly 150 years of combined experience and further solidifies the opportunity to bring new carbon-free energy to the U.S. and North America.”

“The opportunity to team with NuScale and Fluor for the design and construction of small modular reactor plants further extends Sargent & Lundy’s history of being at the forefront of nuclear new generation design,” said Sargent & Lundy Chairman, President and Chief Executive Officer Thomas R. White. “We’re excited to support NuScale’s groundbreaking technology – a simplified, scalable, resilient design that is poised to support global demand.”

Under the new agreement with Sargent & Lundy, Fluor will design the turbine island and balance-of-plant facilities with Sargent & Lundy providing the design for the nuclear island.

NuScale’s groundbreaking Nuclear Regulatory Commission-certified technology is the world’s first and only small modular reactor to gain design certification approval by the U.S. Nuclear Regulatory Commission. Sargent & Lundy and NuScale agreed to work together in late July 2019 with Sargent & Lundy providing standard plant design services as well as architect-engineering support.

In addition to previously announced strategic partners and investors in NuScale, which includes Sargent & Lundy, Fluor and NuScale continue to engage with potential customers, capital investors, manufacturers and other supply chain partners for new small modular reactor development efforts.

About Fluor Corporation

Fluor Corporation (NYSE: FLR) is a global engineering, procurement, fabrication, construction and maintenance company with projects and offices on six continents. Fluor’s 47,000 employees build a better world and provide sustainable solutions by designing, building and maintaining safe, well-executed projects. Fluor is ranked 181 among the Fortune 500 companies. With headquarters in Irving, Texas, Fluor has served its clients for more than 100 years. For more information, please visit www.fluor.com or follow Fluor on Twitter, LinkedIn, Facebook and YouTube.

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Brian Mershon

Global Media Relations

864.281.6484

Jason Landkamer

Investor Relations

469.398.7222

KEYWORDS: United States North America Texas

INDUSTRY KEYWORDS: Engineering Manufacturing Commercial Building & Real Estate Energy Construction & Property Nuclear

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Fluor and Sargent & Lundy will collaborate on new NuScale Power small modular nuclear reactor plant development in North America. (Photo: Business Wire)

Kodiak Sciences Completes Enrollment of DAZZLE Phase 2b/3 Pivotal Study of KSI-301 in Patients with Wet Age-Related Macular Degeneration

− On track for DAZZLE primary endpoint last patient last visit in late 2021 and topline results in early 2022

− Over 550 patients enrolled worldwide

− Phase 3 studies for diabetic macular edema and retinal vein occlusion enrolling well and on track for topline results also in 2022

PR Newswire

PALO ALTO, Calif., Nov. 16, 2020 /PRNewswire/ — Kodiak Sciences Inc. (Nasdaq: KOD), a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases, today announced that recruitment has concluded in its DAZZLE pivotal study of KSI-301, Kodiak’s anti-VEGF antibody biopolymer conjugate, in patients with neovascular (wet) age-related macular degeneration. DAZZLE was planned to enroll 550 treatment-naïve patients worldwide; the target enrollment has been exceeded and recruitment into the study is now closed.

“We are pleased to have exceeded our enrollment target for DAZZLE and to have recruited the study in just over one year despite the challenges presented by the COVID-19 pandemic. We are very grateful for the enthusiasm and support of the retina clinical trial community in working together with us to study KSI-301’s potential,” said Victor Perlroth, Chief Executive Officer of Kodiak Sciences. “With DAZZLE having a one-year primary efficacy endpoint, Kodiak is on track for a top-line data readout of the study in early 2022, an important milestone as part of our 2022 Vision.”

“Wet AMD remains a leading cause of vision loss in the elderly and real-world data show that vision outcomes are compromised by the unsustainable and intensive treatment burden of current medicines. In DAZZLE, we are studying a more pragmatic and achievable regimen of KSI-301 given once every three, four or five months,” said Jason Ehrlich, MD, PhD, Kodiak’s Chief Medical & Development Officer. “We look forward to the last DAZZLE patient’s one-year visit in late 2021 and to analyzing and releasing the primary results in early 2022. The Kodiak team is also executing well on the rest of the KSI-301 development program. Our pivotal studies in diabetic macular edema (DME) and retinal vein occlusion are off to a strong start. The recent presentation of KSI-301 data at the American Academy of Ophthalmology Virtual Meeting highlighted the promising combination of efficacy and durability seen with KSI-301 in DME, a leading cause of vision loss in working-aged people.”

About the DAZZLE Study

The Phase 2b/3 DAZZLE study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve wet AMD. Patients are randomized to receive either KSI-301 on an individualized dosing regimen as infrequently as every five months and no more often than every three months or to receive aflibercept on its labeled every eight-week dosing regimen, each after three monthly initiating doses. The study has enrolled over 550 patients worldwide. The primary endpoint is at one year and each patient will be treated and followed for two years. Additional information about DAZZLE (also called Study KSI-CL-102) can be found on www.clinicaltrials.gov under Trial Identifier NCT04049266 (https://clinicaltrials.gov/show/NCT04049266).

About the GLEAM and GLIMMER Studies

The Phase 3 GLEAM and GLIMMER studies are global, multi-center, randomized studies designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve diabetic macular edema (DME). In each study, patients are randomized to receive either intravitreal KSI-301 on an individualized dosing regimen every eight to 24 weeks after only three loading doses or intravitreal aflibercept every eight weeks after five loading doses per its label. Each study is expected to enroll approximately 450 patients worldwide. The primary endpoint for both studies is the change from baseline in best-corrected vision at one year, and patients will be treated and followed for two years. Additional information about the GLEAM study (also called Study KS301P104) and the GLIMMER study (also called Study KS301P105) can be found on www.clinicaltrials.gov under Trial Identifiers NCT04611152 and NCT04603937, respectively (https://clinicaltrials.gov/ct2/show/NCT04611152 and https://clinicaltrials.gov/ct2/show/NCT04603937).

About the BEACON Study

The Phase 3 BEACON study is a global, multi-center, randomized study designed to evaluate the efficacy, durability and safety of KSI-301 in patients with treatment-naïve macular edema due to retinal vein occlusion (RVO), including both branch and central subtypes. Patients are randomized to receive either intravitreal KSI-301 every eight weeks after only two loading doses or monthly intravitreal aflibercept per its label, for the first six months. In the second six months, patients in both groups will receive treatment on an individualized basis per protocol-specified criteria. The study is expected to enroll approximately 550 patients worldwide. The primary endpoint is the change from baseline in best-corrected vision at six months, and patients will be treated and followed for one year. Additional information about the BEACON study (also called Study KS301P103) can be found on www.clinicaltrials.gov under Trial Identifier NCT04592419 (https://clinicaltrials.gov/show/NCT04592419).

About KSI-301

KSI-301 is an investigational anti-VEGF therapy built on the Kodiak’s Antibody Biopolymer Conjugate (ABC) Platform and is designed to maintain potent and effective drug levels in ocular tissues for longer than existing agents. Kodiak’s objective with KSI-301 is to develop a new first-line agent to improve outcomes for patients with retinal vascular diseases and to enable earlier treatment and prevention of vision loss for patients with diabetic eye disease. The Company’s Phase 2b/3 DAZZLE pivotal study in patients with treatment-naïve wet AMD was initiated in October 2019, and Kodiak initiated the Phase 3 GLEAM, GLIMMER, and BEACON pivotal studies of KSI-301 in diabetic macular edema and retinal vein occlusion in September 2020. These studies are anticipated to form the basis of the Company’s initial BLA to support potential approval and commercialization. An additional pivotal study in patients with non-proliferative diabetic retinopathy is planned. Kodiak Sciences Inc. is developing KSI-301 and owns global rights to KSI-301.

About the KSI-301 Clinical Program

The KSI-301 Clinical Program is designed to assess KSI-301’s safety, efficacy and durability in wet AMD, DME, RVO and non-proliferative DR (without DME) through clinical studies run in parallel. We are conducting two Phase 3 studies in DME (the GLEAM and GLIMMER studies) to provide the mutually confirmatory studies required by FDA for initial demonstration of safety and efficacy. We also are conducting one study in wet AMD (our ongoing DAZZLE study) and one study in RVO (the BEACON study) to support approval in these indications. We intend to file this package together in a single BLA in 2022. We also plan to run an additional study in patients with non-proliferative DR without DME (the GLOW study). We expect that the global KSI-301 clinical program will be conducted at 150+ study sites in more than 10 countries.

About Kodiak Sciences Inc.

Kodiak (Nasdaq: KOD) is a biopharmaceutical company committed to researching, developing and commercializing transformative therapeutics to treat high prevalence retinal diseases. Founded in 2009, we are focused on bringing new science to the design and manufacture of next generation retinal medicines to prevent and treat the leading causes of blindness globally. Our ABC Platform™ uses molecular engineering to merge the fields of antibody-based and chemistry-based therapies and is at the core of Kodiak’s discovery engine. Kodiak’s lead product candidate, KSI-301, is a novel anti-VEGF antibody biopolymer conjugate being developed for the treatment of retinal vascular diseases including age-related macular degeneration, the leading cause of blindness in elderly patients in the developed world, and diabetic eye diseases, the leading cause of blindness in working-age patients in the developed world. Kodiak has leveraged its ABC Platform to build a pipeline of product candidates in various stages of development including KSI-501, our bispecific anti-IL-6/VEGF biopolymer conjugate for the treatment of neovascular retinal diseases with an inflammatory component, and we are expanding our early research pipeline to include ABC Platform based triplet inhibitors for multifactorial retinal diseases such as dry AMD and glaucoma. Kodiak is based in Palo Alto, CA. For more information, please visit www.kodiak.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are not based on historical fact and include statements regarding our beliefs about the timing of top-line data readout of the DAZZLE study; KSI-301’s clinical efficacy, durability and safety, as well as KSI-301’s potential to be a more pragmatic and achievable regimen compared to current medicines; our ability to achieve our 2022 Vision; future development plans; clinical and regulatory objectives and the timing thereof, anticipated design of planned clinical trials, expectations regarding the potential efficacy and commercial potential of our product candidates; the anticipated presentation of data; the results of our research and development efforts and our ability to advance our product candidates into later stages of development. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “plan,” “believe,” “intend,” “pursue,” and other similar expressions among others. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the preliminary safety, efficacy and durability data for our KSI-301 product candidates will not continue or persist; cessation or delay of any of the ongoing clinical studies and/or our development of KSI-301 may occur; future potential regulatory milestones of KSI-301, including those related to current and planned clinical studies may be insufficient to support regulatory submissions or approval; anticipated presentation of data at upcoming conferences may not occur; our research and development efforts and our ability to advance our product candidates into later stages of development may fail; any one or more of our product candidates may not be successfully developed, approved or commercialized; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and Kodiak undertakes no obligation to update forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

Kodiak®, Kodiak Sciences®, ABC™, ABC Platform™ and the Kodiak logo are registered trademarks or trademarks of Kodiak Sciences Inc. in various global jurisdictions.

Cision View original content:http://www.prnewswire.com/news-releases/kodiak-sciences-completes-enrollment-of-dazzle-phase-2b3-pivotal-study-of-ksi-301-in-patients-with-wet-age-related-macular-degeneration-301173275.html

SOURCE Kodiak Sciences Inc.

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Moderna Announces Longer Shelf Life for its COVID-19 Vaccine Candidate at Refrigerated Temperatures

Vaccine candidate now expected to remain stable at standard refrigerator temperatures of 2° to 8°C (36° to 46°F) for 30 days, up from previous estimate of 7 days

Shipping and long-term storage conditions at standard freezer temperatures of -20°C (-4°F) for 6 months

mRNA-1273 to be distributed using widely available vaccine delivery and storage infrastructure

No dilution required prior to vaccination

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced new data showing that mRNA-1273, its COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to 46°F), the temperature of a standard home or medical refrigerator, for 30 days. Stability testing supports this extension from an earlier estimate of 7 days. mRNA-1273 remains stable at -20° C (-4°F) for up to six months, at refrigerated conditions for up to 30 days and at room temperature for up to 12 hours.

“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” said Juan Andres, Chief Technical Operations and Quality Officer at Moderna. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”

Shipping & Long-term Storage: For shipping and longer-term storage, Moderna expects that mRNA-1273 will be maintained at -20°C (-4°F), equal to most home or medical freezer temperatures, for up to 6 months. Using standard freezer temperatures of -20°C (range of -25° to -15°C or -13° to 5°F) is an easier and more established method of distribution and storage than deep freezing and most pharmaceutical distribution companies have the capability to store and ship products at -20°C (-4°F) worldwide.

Refrigeration Storage: After thawing, to facilitate storage at points of administration, Moderna expects that mRNA-1273 will remain stable at standard refrigerated conditions of 2° to 8°C (36° to 46°F) for up to 30 days within the 6-month shelf life. The stability at refrigerated conditions allows for storage at most pharmacies, hospitals, or physicians’ offices.

Room Temperature for Vaccination: Once the vaccine is removed from the refrigerator for administration, it can be kept at room temperature conditions for up to 12 hours.

No Dilution Required at Vaccination Site: The vaccine will not require onsite dilution or special handling, which facilitates vaccination across a range of settings including pharmacies and physicians’ offices.

The Company anticipates that it will continue to gather additional stability information over the coming months to assess whether mRNA-1273 can be shipped and stored under increasingly flexible conditions, which will be described in detail following regulatory approval.

The mRNA-1273 COVID-19 vaccine candidate is Moderna’s tenth mRNA vaccine to enter the clinic. With its experience in prophylactic vaccine development and investments in mRNA platform and delivery technology, Moderna has developed enhanced manufacturing processes, resulting in proprietary lipid nanoparticle technology that Moderna believes will enable the vaccine to be stored at standard pharmaceutical distribution temperatures.

Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an Emergency Use Authorization and/or similar global authorizations. The Company is also working closely with the U.S. Food and Drug Administration (FDA) to submit data from its ongoing stability testing for approval.

About mRNA-1273

mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from NIAID’s Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study completed enrollment.

Results from the second interim analysis of the NIH-led Phase 1 study of mRNA-1273 in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On July 28, results from a non-human primate preclinical viral challenge study evaluating mRNA-1273 were published in The New England Journal of Medicine. On July 14, an interim analysis of the original cohorts in the NIH-led Phase 1 study of mRNA-1273 was published in The New England Journal of Medicine. mRNA-1273 currently is not approved for use by any regulatory body.

BARDA is supporting the continued research and development of mRNA-1273 with $955 million in federal funding under Contract no. 75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the allowable costs incurred by the Company for conducting the program described in the BARDA contract. The U.S. government has agreed to provide up to $1.525 billion to purchase supply of mRNA-1273 under U.S. Department of Defense Contract No. W911QY-20-C-0100.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine (mRNA-1273) against the novel coronavirus, the conditions under which mRNA-1273 can be shipped, stored and administered, and the U.S. government’s potential purchases of mRNA-1273. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could”, “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others: the fact that there has never been a commercial product utilizing mRNA technology approved for use; the fact that the rapid response technology in use by Moderna is still being developed and implemented; the fact that the safety and efficacy of mRNA-1273 has not yet been established; despite having ongoing interactions with the FDA or other regulatory agencies, the FDA or such other regulatory agencies may not agree with the Company’s regulatory approval strategies, components of our filings, such as clinical trial designs, conduct and methodologies, or the sufficiency of data submitted; potential adverse impacts due to the global COVID-19 pandemic such as delays in regulatory review, manufacturing and clinical trials, supply chain interruptions, adverse effects on healthcare systems and disruption of the global economy; and those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s most recent Quarterly Report on Form 10-Q filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.

Moderna Contacts

Media:

Colleen Hussey

Director, Corporate Communications

617-335-1374

[email protected]

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834

[email protected]

KEYWORDS: Massachusetts United States North America

INDUSTRY KEYWORDS: Health Infectious Diseases Other Health Clinical Trials Pharmaceutical Biotechnology

MEDIA:

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China Online Education Group to Report Third Quarter 2020 Financial Results on Monday, November 23, 2020

Earnings Call Scheduled for 8:00 a.m. EST on November 23, 2020

PR Newswire

BEIJING, Nov. 16, 2020 /PRNewswire/ — China Online Education Group (“51Talk”, or the “Company”) (NYSE: COE), a leading online education platform in China, with core expertise in English education, today announced that it will report its third quarter 2020 unaudited financial results on Monday, November 23, 2020, before the open of U.S. markets.

The Company’s management will host an earnings conference call at 8:00 a.m. U.S. Eastern Time on November 23, 2020 (9:00 p.m. Beijing/Hong Kong time on November 23, 2020).

Dial-in details for the earnings conference call are as follows:

United States Toll:

+1-866-264-5888

International:

+1-412-317-5226

Mainland China Toll:

400-120-1203

Hong Kong Toll:

800-905-945

Hong Kong-Local Toll:

+852-3018-4992

Participants should dial-in at least 10 minutes before the scheduled start time and ask to be connected to the call for “China Online Education Group.”

Additionally, a live and archived webcast of the conference call will be available on the Company’s investor relations website at http://ir.51talk.com.

A replay of the conference call will be accessible approximately one hour after the conclusion of the live call until November 30, 2020, by dialing the following telephone numbers:

United States Toll:

+1-877-344-7529

International Toll:

+1-412-317-0088

Replay Access Code:

10150031

About China Online Education Group

China Online Education Group (NYSE: COE) is a leading online education platform in China, with core expertise in English education. The Company’s mission is to make quality education accessible and affordable. The Company’s online and mobile education platforms enable students across China to take live interactive English lessons with overseas foreign teachers, on demand. The Company connects its students with a large pool of highly qualified foreign teachers that it assembled using a shared economy approach, and employs student and teacher feedback and data analytics to deliver a personalized learning experience to its students.

For more information, please visit http://ir.51talk.com.

Cision View original content:http://www.prnewswire.com/news-releases/china-online-education-group-to-report-third-quarter-2020-financial-results-on-monday-november-23-2020-301173513.html

SOURCE China Online Education Group