What to Look for in a Biotech Stock

Image Credit: Marco Verch (Flickr)

Steps to Discover Which Biotech Stocks May Get Hot

The biotech sector is in and of itself exciting. A company developing an idea that can improve human lives, decrease suffering, or even prevent death, by nature, could be a more rewarding endeavor than investing in a company that, by comparison, does little to make a big difference. If, at the same time, the opportunity to return the investor a multiple over returns available elsewhere in the market, then the motivation to allocate a portion of investment capital increases dramatically. But how does an investor gauge a company in the biotech sector and evaluate its chance of survival and likelihood of success?

As with much of investing, sure things don’t often provide a good return. And adding risk doesn’t necessarily equate to added return. The higher perceived risk of a sector such as biotech needs to be offset by research. Filtering stocks through a selection process is key, so the probability of picking those that survive and thrive is higher than average.

I spoke with Robert LeBoyer, the Senior Life Sciences Analyst at Noble Capital Markets, and asked him to list factors to improve the likelihood of choosing a successful biotech company. His knowledge and enthusiasm for the sector caused me to want to share what I learned.

Differentiation

Companies developing a drug that is different than all that came before for what it proposes to treat or prevent stand a good chance of getting funding to make it through the different phases of study. With a development time of 3-5 years, it is best if there is a clear unmet need for the therapy or no current therapies at all.

Investors should determine if there are treatments presently and ask whether the drug or treatment mechanism is a significant improvement over any current product. Also is the field crowded or will it soon be crowded with alternatives to what a company may bring to market? LeBoyer recommended asking where there is an improvement. He gave the example of many cholesterol-lowering drugs, which he said all target the same enzyme. A company with a drug that similarly targets that enzyme may not be worth exploring. Learning of a company that has a different mechanism of action, one which shows promise of greater efficacy, or, reduced cost, or fewer side effects may be worth exploring further.

As an example of a company that had met these criteria some years back, Gilead received approval for a once-daily tablet to treat hepatitis C. Prior to this, the only treatment options involved a year-long regimen of weekly interferon injections and ribavirin tablets. The side effects were depression, nausea, flu-like symptoms, and a reduction in some blood cells. The cost of the injections and treatments could cost a health insurer $1 million over the life of the patient. The Gilead treatment, which has a price tag of $93,000, is mathematically more cost-effective. The therapy which Gilead got approved in the U.S. in 2013 was a better treatment than what existed, and even better tolerated by patients. The stock went from $20 to $120 in about a years time after approval.

Development

Clinical development was another attribute brought up by Noble’s analyst. With even the best proof of concept or early-stage trial success, assessing the chance that clinical stage trials may fail for pipeline candidates is difficult.  This is why a company with a diverse pipeline with a number of products being developed or in later stages of clinical trials, increases the probability of successful biotech investment. Many companies easily pass stage one trials and even stage two, but don’t get past the final hurdle. LeBoyer shared with me a story of a company he now covers that had a vaccine for Covid-19 early on. The human clinical trials, however, were not done in the U.S., but were instead the result of trials on persons mostly of similar lineage. The FDA required a sampling comparable to the diversification of heritage or gene pool in the U.S.  

Obtaining a basic understanding of the FDA side of development is important for anyone making decisions on biotech stocks.

The drug approval process in the U.S. involves multi-layered (Step One through Step Four) with each representing an important milestone on the path to full approval so the product can be brought to market or meet rejection along the path.

Step One is the development phase, Step Two is research, Step Three is Clinical Trials, and Step Four is FDA Approval.

Knowing where companies stands in the FDA step process can help an investor assess the likelihood of approval. Many products, can get to the last step and not be approved, but those just starting out on Step One are a greater risk both in the time it will take and the chance for something to not be to the FDA’s liking.

Finances

Biotech companies, by and large burn through cash in their research, development and trial periods. Understanding how long the cash on hand and other available sources can last before they need to raise more cash, then comparing this with how close to an expected finish line they are, could help an investor steer away from a company that may have a product in the pipeline that meets other key elements investors should look at, but unfortunately, funds may stand in the way of success.

Robert LeBoyer explained that the current high-interest rate environment, coupled with depressed stock prices, makes this particularly important now. For those companies that can borrow, the cost of money is now far more expensive than it had been in the last decade and a half. And issuing more shares, essentially selling more of the company, dilutes the value of shares currently held. It could become a tricky situation that stockholders or those deciding to become a stockholder should monitor

Take Away

Are there companies with a pipeline that includes drugs that meet a large unmet need (as one example, Alzheimer’s), or can attack a disease like cancer in a unique way that would be embraced by the medical community and patients? “Unicorn” companies do exist, but finding them, assessing them, and doing it before a louder investment buzz occurs takes some digging. A solid place to start digging is under the biotech company section on Channelchek.  Available by clicking here, here investors are exposed to many opportunities and the underlying data, the latest news, and of course, thorough company descriptions.

Biotech companies covered by analyst Robert LeBoyer, along with his current research are available here. Channelchek will be highlighting interesting biotechs in future articles and discussing their work and status against the criteria presented above. Join Channelchek to receive emails and gain free access to these articles, video presentations, updated research reports, and news of company roadshows. Visit Rob LeBoyers coverage list here.

Paul Hoffman

Managing Editor, Channelchek

Powell’s Testimony to Congress Revealed A Lot

Image Credit: C-Span (YouTube)

Is the Fed Doing Too Much, Not Enough, or Just Right?

The Fed Reserve Chair Jerome Powell has an ongoing credibility problem. The problem is that markets, economists, and now Congress find him extremely credible. So credible that they have already declared him a winner fighting inflation, or of more pertinence, the economy a loser because Powell and the Fed policymakers have been so resolute in their fight against the rising cost of goods and services that soon there will be an abundance of newly unemployed, businesses will falter, and the stock market will be left in tatters. This view that he has already done too much and that the economy has been overkilled, even while it shows remarkable strength, was echoed many times during his visit to Capital Hill for his twice a year testimony.

“As of the end of December, there were 1.9 job openings for each unemployed individual, close to the all-time peak recorded last March, while unemployment insurance claims have remained near historic lows.” – Federal Reserve Chair Jay Powell (March 8, 2023).

Powell’s Address

Perhaps the most influential individual on financial markets in the U.S. and around the world, Fed Chair Powell continued his hawkish (inflation fighter, interest rate hiker) tone at his Senate and House testimonies. The overall message was; inflation is bad, inflation has been persistent, we will continue on the path to bring it down, also employment is incredibly strong, the employment situation is such that we can do more, we will do more to protect the U.S. economy from the ravages of inflation.

Powell began, “My colleagues and I are acutely aware that high inflation is causing significant hardship, and we are strongly committed to returning inflation to our 2 percent goal.” Powell discussed the forceful actions taken to date and added, “we have more work to do. Our policy actions are guided by our dual mandate to promote maximum employment and stable prices. Without price stability, the economy does not work for anyone. In particular, without price stability, we will not achieve a sustained period of labor market conditions that benefit all.”

Powell discussed the slowed growth last year; there were two periods of negative GDP growth reported during the first two quarters. He mentioned how the once red-hot housing sector is weakening under higher interest rates and that “Higher interest rates and slower output growth also appear to be weighing on business fixed investment.” He then discussed the impact on labor markets, “Despite the slowdown in growth, the labor market remains extremely tight. The unemployment rate was 3.4 percent in January, its lowest level since 1969. Job gains remained very strong in January, while the supply of labor has continued to lag.1 As of the end of December, there were 1.9 job openings for each unemployed individual, close to the all-time peak recorded last March, while unemployment insurance claims have remained near historic lows.”

On the subject of monetary policy, the head of the Federal Reserve mentioned that the target of 2% inflation has not been met and that recent numbers have it moving in the wrong direction. Powell also discussed that the Fed had raised short-term interest rates by adding 4.50%. He suggested that recent economic numbers require that an increase to where the sufficient height of fed funds peaks is likely higher than previously thought. All the while, he added, “we are continuing the process of significantly reducing the size of our balance sheet.”

Powell acknowledged some headway, “We are seeing the effects of our policy actions on demand in the most interest-sensitive sectors of the economy. It will take time, however, for the full effects of monetary restraint to be realized, especially on inflation. In light of the cumulative tightening of monetary policy and the lags with which monetary policy affects economic activity and inflation, the Committee slowed the pace of interest rate increases over its past two meetings.” Powell added, “We will continue to make our decisions meeting by meeting, taking into account the totality of incoming data and their implications for the outlook for economic activity and inflation.”

Questions and Answers

Congressmen both in the Senate and the House use the Semiannual Monetary Policy Report to Congress (formerly known as Humphrey Hawkins Testimony) to ask questions of the person with the most economic insight in Washington. Often their questions have already been covered in the Chair’s opening address, but Congresspeople will ask anyway to show their constituents at home that they are looking after them.

Elizabeth Warren is on the Senate Banking Committee; her math concluded the result of even a 1% increase in unemployment is a two million-worker job loss. Warren asked Powell, “Do you call laying off two million people this year not a sharp increase in unemployment?” “Explain that to the two million families who are going to be out of work.” In his response, Powell went back to historical numbers and reminded the Senator that an increase in unemployment would still rank the current economy above what Americans have lived through in most of our lifetimes, “We’re not, again, we’re not targeting any of that. But I would say even 4.5 percent unemployment is well better than most of the time for the last, you know, 75 years,” Chair Powell answered.

U.S. House Financial Services Committee on Wednesday heard Congressman Frank Lucas concerned about the pressure for the Fed to include climate concerns as an additional Fed mandate. Lucas from Oklahoma asked,  “How careful are you in ensuring that the Fed does not place itself into the climate debate, and how can Congress ensure that the Fed’s regulatory tool kit is not warped into creating policy outcomes?” Powell answered that the Fed has a narrow but real role involving bank supervision. It’s important that individual banks understand and can manage over time their risks from any climate change and it’s impact on business and the economy. He wants to make sure the Fed never assumes a role where they are becoming a climate policymaker.

Other non-policy questions included Central Bank Digital Currencies. House Congressman Steven Lynch showed concerns that the Fed was experimenting with digital currencies. His question concerned receiving a public update on where they are with their partnership with MIT, their testing, and what they are trying to accomplish. Powell’s response seemed to satisfy the Congressman. “we engage with the public on an ongoing basis, we are also doing research on policy, and also technology,” said Powell. Follow-up questions on the architecture of a CBDC, were met with responses that indicated that the Fed, they are not at the stage of making decisions, instead, they are experimenting and learning. “How would this work, does it work, what is the best technology, what’s the most efficient.” Powell emphasized that the U.S. Federal Reserve is at an early stage, but making technological progress. They have not decided from a policy perspective if this is something that the country needs or desires.

Issues at Stake

As it relates to the stock and bond markets, the Fed has been holding overnight interest rates at a level that is more than one percentage point below the rate of inflation. The reality of this situation is that investors and savers that are earning near the Fed Funds rate on their deposits are losing buying power to the erosive effects of inflation. Those that are investing farther out on the yield curve are earning even less than overnight money. The impact here could be worse if inflation remains at current levels or higher, or better if the locked-in yields out longer on the curve are met with inflation coming down early on.

The Fed Chair indicated at the two testimony before both Houses of Congress that inflation has been surprisingly sticky. He also indicated that they might increase their expected stopping point on tightening credit. Interest rates out in the periods are actually lower than they had been in recent days and as much as 0.25% lower than they were last Fall. The lower market rates and inverted yield curve suggest the market thinks the Fed has already won and has likely gone too far. This thought process has made it difficult for the Fed Chair and others at the Fed that discuss a further need to throw cold water on an overheated economy. Fed Tightening has not led to an equal amount of upward movement out on the yield curve. This trust or expectation that the Fed has inflation under control would seem to be undermining the Fed’s efforts. With this, the Fed is likely to have to move even further to get the reaction it desires. The risk of an unwanted negative impact on the economy is heightened by the trust the bond market gives to Powell that he has this under control and may have already won.

Powell’s words are that the Fed has lost ground and has much more work to do.

Take Away

At his semiannual testimony to Congress, an important message was sent to the markets. The Fed has the right tools to do the job of bringing inflation down to the 2% range, but those tools operate on the demand side. In the U.S. we are fortunate to have two jobs open for every person seeking employment. While this is inflationary, it provides policy with more options.

As of the reporting of January economic numbers, a trend may be beginning indicating the Fed is losing its fight against inflation. It is likely that it will have to do more, but the Fed stands willing to do what it takes. Powell ended his prepared address by saying, “Everything we do is in service to our public mission. We at the Federal Reserve will do everything we can to achieve our maximum-employment and price-stability goals.”

Paul Hoffman

Managing Director, Channelchek

Sources

https://www.federalreserve.gov/newsevents/testimony.htm

Release – Harte Hanks Grows Annual Revenue, Increases Profitability and Ends 2022 with Strengthened Balance Sheet

Research News and Market Data on HHS

Company Expects Continued Revenue and EBITDA Growth in 2023

CHELMSFORD, MA / ACCESSWIRE / March 7, 2023 / Harte Hanks, Inc. (NASDAQ:HHS), a leading global customer experience company focused on bringing companies closer to customers for 100 years, today announced financial results for the fourth quarter and full-year period ended December 31, 2022. The results include one month of contribution from the acquisition of InsideOut Solutions in 2022, with no contribution in 2021. In addition, the results reflect the impact of the repurchase of all the Company’s outstanding Series A Convertible Preferred Shares (the “Preferred Shares”) from Wipro, LLC, the sole holder of the Preferred Shares, for a cash payment of $9.9 million, equal to the liquidation value, and 100,000 shares of Harte Hanks common stock.

Harte Hanks CEO, Brian Linscott, commented: “This was an important year for Harte Hanks, with results that reflect the successful culmination of our restructuring and the emergence of sustainable, profitable growth based on a differentiated offering and solid relationships with our top-tier customers. Our improved financial results have enabled us to materially strengthen our balance sheet. We have streamlined our capital structure by eliminating our debt and redeeming our preferred shares, thereby eliminating the dilutive effect of preferred shares going forward. Simultaneously, our pension liability was reduced by nearly $15 million, positioning us to commence the process to transfer one of our qualified pensions to a third party.”

“We have proven our operating leverage and earnings power with continued growth. Our 6% full-year revenue growth translated to a near doubling of operating income and a 75% increase in EBITDA,” concluded Linscott. “Demand for our solutions continues to grow, offsetting headwinds from the culmination of pandemic-related projects. We anticipate continued revenue and EBITDA growth for the full year of 2023, even though our first quarter results will include modest revenue growth and lower EBITDA on a year-over-year basis as result of an abnormally strong comparison period in 2022 driven by revenue mix.”

Fourth Quarter Financial Highlights

  • Revenues increased by 5.4% to $54.8 million, compared to $52.0 million in the same period in the prior year. Revenue for the fourth quarter of 2022 included approximately $1 million in revenue from InsideOut Solutions, acquired on December 1, 2022, with no contribution in the prior-year.
  • Fulfillment & Logistics Services grew 34.4%, offsetting decreases of 6.8% in Marketing Services and 12.9% in Customer Care. Customer Care decreases were largely related to the completion of pandemic-related projects.
  • Operating income of $3.4 million, compared to operating income of $2.9 million in the same period in the prior year, an increase of 19.8%.
  • Net income of $21.8 million, inclusive of a one-time $19.8 million tax benefit due to release of valuation allowance due to the expectation of sustained profitability, and $1.4 million in other expenses mainly related to pension expense and foreign currency loss. This compared to net income of $1.8 million in the same period in the prior year, which included income tax expense of $271,000.
  • Diluted EPS was $2.70 for the fourth quarter of 2022 vs. $0.20 for the same period in the prior year. The tax benefit accounted for approximately $2.62 of the current-period earnings per share.
  • EBITDA was $4.4 million compared to $3.5 million in the same period in the prior year.[1]

[1] EBITDA is a non-GAAP financial measure. See “Supplemental Non-GAAP Financial Measures” below. EBITDA is also the Company’s measure of segment profitability.

Full-Year Financial Highlights

  • Revenues increased by 6.0% to $206.3 million, compared to $194.6 million in the prior year.
  • Fulfillment & Logistics Services grew 35.6%, offsetting declines in Marketing Services of 6.1% and Customer Care of 10.0%.
  • Operating income of $15.1 million, compared to operating income of $7.6 million last year, an increase of 97.8%.
  • Net income of $36.8 million, compared to net income of $15.0 million, last year. The 2022 results included a $19.8 million tax benefit due to release of valuation allowance due to the expectation of sustained profitability, while the 2021 results included a one-time gain of $10.0 million related to the extinguishment of the Company’s PPP loan.
  • Earnings per diluted share of $4.75 compared to $1.76 per diluted share last year.
  • EBITDA 1was $17.8 million compared to $10.2 million last year.1

Segment Highlights

  • Customer Care, $16.7 million in revenue, 30% of total – Revenue decreased by 12.9%, or $2.5 million, from the prior year quarter, and year-over-year EBITDA increased by 24.4% to $3.2 million from $2.6 million. Decrease in revenue was driven by sunsetting of pandemic-related projects, but continuous improvement in retention and reduction in labor costs drove the EBITDA increase. New business wins for the quarter included:
    • A community-based health plan company selected Harte Hanks to support its members with plan related customer support. The company selected Harte Hanks to provide extended support hours for its members while maintaining its CMS 5-star rating. Harte Hanks has consistently delivered high CMS ratings for its clients through its rigorous training and certification process for employees and systems.
    • A global beverage company expanded services with Harte Hanks by extending its Customer Care solution to additional markets. The expansion allows our client to benefit from our lower cost facilities in the Philippines, while improving its customer experience with faster and easier access for support.
  • Fulfillment & Logistics Services, $24.5 million in revenue, 45% of total – Revenue increased by 34.4%, or $6.3 million, compared to the prior year quarter; and year-over-year EBITDA improved 5.9% to $2.3 million from $2.1 million. New business wins for the quarter included:
    • A growing international investment firm with approximately $30 billion of assets under management selected Harte Hanks to provide digital print and premium item fulfillment services to its brokers. Our financial services sector experience and streamlined onboarding to support a rapid pivot from a competitor were key differentiators in the selection process.
    • A leading branding company selected Harte Hanks Fulfillment to manage the production, kitting, and distribution of 250,000 makeup kits for a Fortune 200 retail partner. This partnership continues to lead to new value-added product fulfillment opportunities, unlocked by our investment in flexible, automated production lines.
  • Marketing Services, $13.6 million in revenue, 25% of total – Revenue decreased by 6.8% compared to the prior year quarterand year-over-year EBITDA decreased 18.4% to $2.1 million from $2.6 million. Decrease in revenue was driven by a reduction of Direct Mail work for clients. New business wins for the quarter included:
    • A leading premium brand retailer of Kitchen, Bath and Outdoor products selected Harte Hanks to design and execute a series of lead generation programs. Harte Hanks was chosen based on our extensive experience in retail strategy and ability to deliver a full suite of creative, data, analytics and campaign execution.
    • A leading global technology manufacturer expanded our successful B2B demand generation program into South America by utilizing Harte Hanks Audience Finder product to identify buyers with intent.

Consolidated Fourth Quarter 2022 Results

Fourth quarter revenues were $54.8 million, up 5.4% from $52.0 million in the fourth quarter of 2021. The Company’s Fulfillment & Logistics Services segment grew, more than offsetting declines in Marketing Services and Customer Care.

Fourth quarter operating income was $3.4 million, compared to operating income of $2.9 million in the fourth quarter of 2021. The improvement resulted from the elimination of restructuring expense and higher revenues.

Net income for the quarter was $21.8 million inclusive of $19.8 million tax benefit and $1.4 million in expenses related to pension and currency loss on intercompany receivables, compared to net income of $1.8 million in the fourth quarter last year. The Company recorded an income tax benefit of $19.8 million, or approximately $2.62 per diluted share, in the fourth quarter of 2022, compared to an expense of $271,000 in the fourth quarter of 2021. The tax benefit in the fourth quarter of 2022 was mainly related to the release of the majority of valuation allowances due to the improved profitability of the company. Income attributable to common stockholders for the fourth quarter was $20.4 million, or $2.81 per basic and $2.70 per diluted share (based on 7.6 million weighted average diluted shares outstanding), compared to net income attributable to common shareholders of $1.4 million, or $0.20 per basic and diluted share (based on 7.3 million weighted average diluted shares outstanding) during the prior year fourth quarter. Income attributable to common stockholders was reduced by a $1.4 million one-time loss on redemption of Preferred Stock.

Full-Year 2022 Results

Revenues for 2022 were $206.3 million, up 6.0% from $194.6 million last year. Operating income was $15.1 million, compared to operating income of $7.6 million last year. Net income for the year was $36.8 million (inclusive of a $19.8 million tax benefit due to release of valuation allowance due to the expectation of sustained profitability), compared to net income of $15.0 million (inclusive of a $10.0 million gain related to the forgiveness of the Company’s PPP loan), last year. Income attributable to common stockholders for the year was $35.4 million, or $4.98 per basic share and $4.75 per fully diluted share, compared to net income attributable to common shareholders of $12.6 million, or $1.85 per basic share and $1.76 per fully diluted share.

Balance Sheet and Liquidity

Harte Hanks ended the year with $10.4 million in cash, cash equivalents and restricted cash, compared to $15.1 million at December 31, 2021. At December 31, 2022, the Company had nothing drawn on its line of credit, and $37.8 million in outstanding long-term pension liability. On December 31, 2021, the Company had no short-term debt, $5 million in long-term debt and $52.5 million in outstanding long-term pension liability.

During 2022, Harte Hanks has decreased outstanding debt by $5 million and redeemed its preferred shares for $9.9 million.

The company anticipates receiving a Federal income tax refund related to a net operating loss (NOL) carryback claim of $5.3 million which will further enhance liquidity.

Conference Call Information

The Company will host a conference call and live webcast to discuss these results on Tuesday, March 7, 2023 at 4:30 p.m. EST. Interested parties may access the webcast at https://investors.hartehanks.com/events or may access the conference call by dialing (877) 545-0523 in the United States or (973) 528-0016 from outside the U.S. and using access code 471821.

A replay of the call can also be accessed via phone through March 21, 2023 by dialing (877) 481-4010 from the U.S., or (919) 882-2331 from outside the U.S. The conference call replay passcode is 47696.

About Harte Hanks:

Harte Hanks (NASDAQ:HHS) is a leading global customer experience company whose mission is to partner with clients to provide them with CX strategy, data-driven analytics and actionable insights combined with seamless program execution to better understand, attract and engage their customers.

Using its unparalleled resources and award-winning talent in the areas of Customer Care, Fulfillment and Logistics, and Marketing Services, Harte Hanks has a proven track record of driving results for some of the world’s premier brands, including Bank of America, GlaxoSmithKline, Unilever, Pfizer, HBOMax, Volvo, Ford, FedEx, Midea, Sony and IBM among others. Headquartered in Chelmsford, Massachusetts, Harte Hanks has over 2,500 employees in offices across the Americas, Europe, and Asia Pacific.

For more information, visit hartehanks.com

As used herein, “Harte Hanks” or “the Company” refers to Harte Hanks, Inc. and/or its applicable operating subsidiaries, as the context may require. Harte Hanks’ logo and name are trademarks of Harte Hanks.

Cautionary Note Regarding Forward-Looking Statements:

Our press release and related earnings conference call contain “forward-looking statements” within the meaning of U.S. federal securities laws. All such statements are qualified by this cautionary note, provided pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements other than historical facts are forward-looking and may be identified by words such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “seeks,” “could,” “intends,” or words of similar meaning. These forward-looking statements are based on current information, expectations and estimates and involve risks, uncertainties, assumptions and other factors that are difficult to predict and that could cause actual results to vary materially from what is expressed in or indicated by the forward-looking statements. In that event, our business, financial condition, results of operations or liquidity could be materially adversely affected and investors in our securities could lose part or all of their investments. These risks, uncertainties, assumptions and other factors include: (a) local, national and international economic and business conditions, including (i) the outbreak of diseases, such as the COVID-19 coronavirus, which has curtailed travel to and from certain countries and geographic regions, created supply chain disruption and shortages, disrupted business operations and reduced consumer spending, (ii) market conditions that may adversely impact marketing expenditures, (iii) the impact of the Russia/Ukraine conflict on the global economy and our business, including impacts from related sanctions and export controls and (iv) the impact of economic environments and competitive pressures on the financial condition, marketing expenditures and activities of our clients and prospects; (b) the demand for our products and services by clients and prospective clients, including (i) the willingness of existing clients to maintain or increase their spending on products and services that are or remain profitable for us, and (ii) our ability to predict changes in client needs and preferences; (c) economic and other business factors that impact the industry verticals we serve, including competition and consolidation of current and prospective clients, vendors and partners in these verticals; (d) our ability to manage and timely adjust our facilities, capacity, workforce and cost structure to effectively serve our clients; (e) our ability to improve our processes and to provide new products and services in a timely and cost-effective manner though development, license, partnership or acquisition; (f) our ability to protect our facilities against security breaches and other interruptions and to protect sensitive personal information of our clients and their customers; (g) our ability to respond to increasing concern, regulation and legal action over consumer privacy issues, including changing requirements for collection, processing and use of information; (h) the impact of privacy and other regulations, including restrictions on unsolicited marketing communications and other consumer protection laws; (i) fluctuations in fuel prices, paper prices, postal rates and postal delivery schedules; (j) the number of shares, if any, that we may repurchase in connection with our repurchase program; (k) unanticipated developments regarding litigation or other contingent liabilities; (l) our ability to complete anticipated divestitures and reorganizations, including cost-saving initiatives; (m) our ability to realize the expected tax refunds; and (n) other factors discussed from time to time in our filings with the Securities and Exchange Commission, including under “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2021 which was filed on March 21, 2022. The forward-looking statements in this press release and our related earnings conference call are made only as of the date hereof, and we undertake no obligation to update publicly any forward-looking statement, even if new information becomes available or other events occur in the future.

Supplemental Non-GAAP Financial Measures:

The Company reports its financial results in accordance with generally accepted accounting principles (“GAAP”). However, the Company may use certain non-GAAP measures of financial performance in order to provide investors with a better understanding of operating results and underlying trends to assess the Company’s performance and liquidity in this press release and our related earnings conference call. We have presented herein a reconciliation of these measures to the most directly comparable GAAP financial measure.

The Company presents the non-GAAP financial measure “Adjusted Operating Income (Loss)” as a measure useful to both management and investors in their analysis of the Company’s financial results because it facilitates a period-to-period comparison of Operating Revenue and Operating Income (Loss) by excluding restructuring expense, impairment expense and stock-based compensation. The most directly comparable measure for this non-GAAP financial measure is Operating Income (Loss).

The Company presents the non-GAAP financial measure “EBITDA” as a supplemental measure of operating performance in order to provide an improved understanding of underlying performance trends. The Company defines “Adjusted EBITDA” as earnings before interest expense net, income tax expense (benefit) and depreciation expense. The most directly comparable measure for EBITDA is Net Income (Loss). We believe EBITDA is an important performance metric because it facilitates the analysis of our results, exclusive of certain non-cash items, including items which do not directly correlate to our business operations; however, we urge investors to review the reconciliation of non-GAAP EBITDA to the comparable GAAP Net Income (Loss), which is included in this press release, and not to rely on any single financial measure to evaluate the Company’s financial performance.

The use of non-GAAP measures do not serve as a substitute and should not be construed as a substitute for GAAP performance but should provide supplemental information concerning our performance that our investors and we find useful. The Company evaluates its operating performance based on several measures, including this non-GAAP financial measures. The Company believes that the presentation of this non-GAAP financial measures in this press release and earnings conference call presentations are useful supplemental financial measures of operating performance for investors because they facilitate investors’ ability to evaluate the operational strength of the Company’s business. However, there are limitations to the use of this non-GAAP measures, including that they may not be calculated the same by other companies in our industry limiting their use as a tool to compare results. Any supplemental non-GAAP financial measures referred to herein are not calculated in accordance with GAAP and they should not be considered in isolation or as substitutes for the most comparable GAAP financial measures.

EBITDA is the Company’s measure of segment profitability.

Investor Relations Contact:

Rob Fink or Tom Baumann
646.809.4048 / 646.349.6641
FNK IR
HHS@fnkir.com

Source: Harte Hanks, Inc.

View source version on accesswire.com:
https://www.accesswire.com/742474/Harte-Hanks-Grows-Annual-Revenue-Increases-Profitability-and-Ends-2022-with-Strengthened-Balance-Sheet

Release – Entravision Schedules Fourth Quarter and Full Year 2022 Earnings Release And Conference Call

Research News and Market Data on EVC

03/07/2023

SANTA MONICA, Calif.–(BUSINESS WIRE)– Entravision (NYSE: EVC), a leading global advertising solutions, media and technology company, announced that it will release its fourth quarter and full year 2022 financial results after market close on Thursday, March 9, 2023. The Company will host a conference call that day at 5:00 p.m. Eastern Time to discuss the fourth quarter and full year 2022 results.

To access the conference call, please dial (844) 836-8739 (U.S.) or (412) 317-5440 (International) ten minutes prior to the start time. The call will also be available via live webcast on the investor relations portion of the Company’s website located at www.entravision.com.

If you cannot listen to the conference call at its scheduled time, there will be a replay available through Thursday, March 23, 2023 which can be accessed by dialing (844) 512-2921 (U.S.) or (412) 317-6671 (International) and entering the passcode 10176187. The webcast will also be archived on the Company’s website.

About Entravision

Entravision is a leading global advertising, media and ad-tech solutions company connecting brands to consumers by representing top platforms and publishers. Our dynamic portfolio includes digital, television and audio offerings. Digital, our largest revenue segment, is comprised of four business units: our digital sales representation business; Smadex, our programmatic ad purchasing platform; our branding and mobile performance solutions business; and our digital audio business. Through our digital sales representation business, we connect global media companies such as Meta, Twitter, TikTok and Spotify with advertisers in primarily emerging growth markets worldwide. Smadex is our mobile-first demand side platform, enabling advertisers to execute performance campaigns using machine learning. We also offer a branding and mobile performance solutions business, which provides managed services to advertisers looking to connect with global consumers, primarily on mobile devices, and our digital audio business provides digital audio advertising solutions for advertisers in the Americas. In addition to digital, Entravision has 49 television stations and is the largest affiliate group of the Univision and UniMás television networks. Entravision also manages 45 primarily Spanish-language radio stations that feature nationally recognized, Emmy award-winning talent. Shares of Entravision Class A Common Stock trade on the NYSE under ticker: EVC. Learn more about our offerings at entravision.com or connect with us on LinkedIn and Facebook.

For more information, please contact:

Christopher T. Young
Interim Chief Executive Officer
Entravision
310-447-3870

Kimberly Esterkin
Addo Investor Relations
310-829-5400
evc@addo.com

Source: Entravision

Release – Tonix Pharmaceuticals Announces Results from a Preclinical Study of Murine TNX-1700 Presented in a Poster at the Keystone Symposia, “Cancer Immunotherapy: Mechanisms of Response Versus Resistance”

Research News and Market Data on TNXP

March 07, 2023 7:00am EST

Murine TNX-1700 (mTNX-1700) Enhances Anti-Tumor Activity of PD-1 Blockade in Mouse Models of Colorectal Cancer

TNX-1700 is in Development as Monotherapy and in Combination with Anti-PD-1 Checkpoint Inhibitor Therapy for Colorectal and Gastric Cancers

In Animal Models of Colorectal Cancer, mTNX-1700 Treatment Leads to the Activation of Cancer-Killing CD8+ T Cells and Limits Immune Evasion by Cancer Cells

CHATHAM, N.J., March 07, 2023 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (Tonix or the Company), a clinical-stage biopharmaceutical company, today announced that preclinical results of mTNX-1700 (recombinant murine TFF2-murine serum albumin, or MSA, fusion protein) were presented in a poster at the Keystone Symposia, “Cancer Immunotherapy: Mechanisms of Response Versus Resistance” on March 6, 2023, at the Fairmont Banff Springs Conference Center in Banff, Alberta, Canada. The poster can be found on the Scientific Presentations page of Tonix’s website.

The poster, titled “TFF2-MSA Suppresses Tumor Growth and Increases Survival in an anti-PD-1 Treated MC38 Colorectal Cancer Model by Targeting MDSCs,” includes data from preclinical studies which evaluated the ability of mTNX-1700 to treat colorectal cancer as monotherapy or in combination with anti-PD-1 in mouse models. TNX-1700 targets myeloid-derived suppressor cells (MDSCs) which interfere with the immune response to cancer by suppressing the CD8+ T cell response and creating a toxic tumor microenvironment. The data show that mTNX-1700 and anti-PD-1 monotherapy each were able to evoke anti-tumor immunity in the MC38 model of colorectal cancer, and that mTNX-1700 augmented the anti-tumor efficacy of anti-PD-1 therapy in two different colorectal cancer models. Tonix is developing TNX-1700 (recombinant human TFF2-human serum albumin or HSA) for the treatment of colon and gastric cancers.

“Anti-PD-1 treatment has revolutionized the treatment of other cancers and is known as immuno-oncology,” said Seth Lederman, M.D., Chief Executive Officer of Tonix. “Colorectal cancer is notoriously unresponsive to anti-PD-1 treatment. Much research has been focused on trying to turn anti-PD-1 unresponsive tumors into anti-PD-1 responsive tumors.”

Bruce Daugherty, Ph.D., Executive Vice President, Research of Tonix, the presenter and lead author of the study added, “we believe that the data from these preclinical studies demonstrate that mTNX-1700 treatment augmented the response of two different models of colorectal tumors. In addition, it was shown that mTNX-1700 inhibits the MDSCs which contribute to the toxic element of the tumor microenvironment. Together these findings support the idea that whether a tumor is anti-PD1 non-responsive or responsive may relate to the tumor microenvironment rather than the tumor itself. We are excited to start additional work to learn if TNX-1700 therapy modifies the toxic tumor microenvironment in humans and will make colorectal cancer responsive to anti-PD-1 therapy.”

About Trefoil Factor 2 (TFF2)
Human TFF2 is a secreted protein, encoded by the TFF2 gene in humans, that is expressed in gastrointestinal mucosa where it functions to protect and repair mucosa. TFF2 is also expressed at low levels in splenic immune cells and is now appreciated to have intravascular roles in the spleen and in the tumor microenvironment. In gastric cancer, TFF2 is epigenetically silenced, and TFF2 is suggested to be protective against cancer development through several mechanisms. Tonix is developing TNX-1700 (rTFF2-HSA) for the treatment of gastric and colon cancers under a license from Columbia University. Columbia was granted patent claims, which, excluding possible patent term extensions, is expected to provide U.S. market exclusivity until April 2, 20331,2.   The inventor at Columbia is Dr. Timothy Wang, who is an expert in the molecular mechanisms of carcinogenesis whose research has focused on the carcinogenic role of inflammation in modulating stem cell functions. Dr. Wang demonstrated that knocking out the mTFF2 gene in mice leads to faster tumor growth and that overexpression of TFF2 markedly suppresses tumor growth by curtailing the homing, differentiation, and expansion of MDSCs to allow activation of cancer-killing CD8+ T cells3. He went on to show that a novel engineered form of recombinant murine TFF2 (mTFF2-CTP) had an extended half-life in vivo and was able to suppress MDSCs and tumor growth in an animal model of colorectal cancer. Later, he showed in gastric cancer models that suppressing MDSCs using chemotherapy enhances the effectiveness of anti-PD1 therapy and significantly reduces tumor growth.4 Dr. Wang proposed the concept of employing rTFF2 in combination with other therapies in cancer prevention and early treatment. Dr. Wang presented data at the American Association for Cancer Research (AACR) conference as a collaboration between Tonix and Columbia University in 20205 that includes data from a preclinical study which investigated the role of PD-L1 in colorectal tumorigenesis and evaluated the utility of targeting myeloid-derived suppressor cells (MDSCs) in combination with PD-1 blockade in mouse models of colorectal cancer. The data show that anti-PD-1 monotherapy was unable to evoke anti-tumor immunity in this model of colorectal cancer, but mTFF2-CTP augmented the efficacy of anti-PD-1 therapy. Anti-PD-1 in combination with TFF2-CTP showed greater anti-tumor activity in PD-L1-overexpressing mice.

1Tonix Pharmaceuticals Announces Licensing Agreement with Columbia University for the Development of Recombinant Trefoil Family Factor 2 (rTFF2), or TNX-1700, for the Treatment of Gastric and Pancreatic Cancers :: Tonix Pharmaceuticals Holding Corp. (TNXP)
2The U.S. Patent and Trademark Office issued U.S. Patent No. 11,167,010 on November 9, 2021.
3Dubeykovskaya ZA et al, Nat Commun 2016
4Kim W et al, Gastroenterology 2021
5Tonix Pharmaceuticals Announces Results from Preclinical Study of TNX-1700 Presented in a Poster at AACR Virtual Annual Meeting 2020 :: Tonix Pharmaceuticals Holding Corp. (TNXP)

Tonix Pharmaceuticals Holding Corp.*

Tonix is a clinical-stage biopharmaceutical company focused on discovering, licensing, acquiring and developing therapeutics to treat and prevent human disease and alleviate suffering. Tonix’s portfolio is composed of central nervous system (CNS), rare disease, immunology and infectious disease product candidates. Tonix’s CNS portfolio includes both small molecules and biologics to treat pain, neurologic, psychiatric and addiction conditions. Tonix’s lead CNS candidate, TNX-102 SL (cyclobenzaprine HCl sublingual tablet), is in mid-Phase 3 development for the management of fibromyalgia with a new Phase 3 study launched in the second quarter of 2022 and interim data expected in the second quarter of 2023. TNX-102 SL is also being developed to treat Long COVID, a chronic post-acute COVID-19 condition. Tonix initiated a Phase 2 study in Long COVID in the third quarter of 2022. TNX-1300 (cocaine esterase) is a biologic designed to treat cocaine intoxication and has been granted Breakthrough Therapy designation by the FDA. A Phase 2 study of TNX-1300 is expected to be initiated in the second quarter of 2023. TNX-1900 (intranasal potentiated oxytocin), a small molecule in development for chronic migraine, is being studied in a potential pivotal Phase 2 study that initiated enrollment in the first quarter of 2023 and for which interim data is expected in the fourth quarter of 2023. TNX-601 ER (tianeptine hemioxalate extended-release tablets) is a once-daily formulation of tianeptine being developed as a potential treatment for major depressive disorder (MDD) with a Phase 2 study expected to be initiated in the first quarter of 2023. Tonix’s rare disease portfolio includes TNX-2900 (intranasal potentiated oxytocin) for the treatment of Prader-Willi syndrome. TNX-2900 has been granted Orphan Drug designation by the FDA. Tonix’s immunology portfolio includes biologics to address organ transplant rejection, autoimmunity and cancer, including TNX-1500, which is a humanized monoclonal antibody targeting CD40-ligand (CD40L or CD154) being developed for the prevention of allograft and xenograft rejection and for the treatment of autoimmune diseases. A Phase 1 study of TNX-1500 is expected to be initiated in the second quarter of 2023. Tonix’s infectious disease pipeline includes a vaccine in development to prevent smallpox and monkeypox, TNX-801; a next-generation vaccine to prevent COVID-19, TNX-1850; a platform to make fully human monoclonal antibodies to treat COVID-19, TNX-3600; humanized anti-SARS-CoV-2 monoclonal antibodies, TNX-3800; and a class of broad-spectrum small molecule oral antivirals, TNX-3900. TNX-801, Tonix’s vaccine in development to prevent smallpox and monkeypox, also serves as the live virus vaccine platform or recombinant pox vaccine (RPV) platform for other infectious diseases. A Phase 1 study of TNX-801 is expected to be initiated in the second half of 2023.

*All of Tonix’s product candidates are investigational new drugs or biologics and have not been approved for any indication.

This press release and further information about Tonix can be found at www.tonixpharma.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. These forward-looking statements are based on Tonix’s current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; delays and uncertainties caused by the global COVID-19 pandemic; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the Securities and Exchange Commission (the “SEC”) on March 14, 2022, and periodic reports filed with the SEC on or after the date thereof. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.

Contacts

Jessica Morris (corporate)
Tonix Pharmaceuticals
investor.relations@tonixpharma.com
(862) 904-8182

Olipriya Das, Ph.D. (media)
Russo Partners
Olipriya.Das@russopartnersllc.com
(646) 942-5588

Peter Vozzo (investors)
ICR Westwicke
peter.vozzo@westwicke.com
(443) 213-0505

Source: Tonix Pharmaceuticals Holding Corp.

Released March 7, 2023

Release – Comstock Metals Recycling Subsidiary Sells Facility For $27 Million

Research News and Market Data on LODE

VIRGINIA CITY, NEVADA, March 7, 2023 – Comstock Inc. (NYSE: LODE) (“Comstock” and the “Company”) today announced agreements by LINICO Corporation, Comstock’s 88% owned subsidiary (“LiNiCo”), to sell LiNiCo’s facility at 2500 Peru Drive, McCarran, Nevada, for a gross price of $27 million. The facility was being leased pursuant to an agreement that permitted LiNiCo to purchase the facility for a purchase price of $15.25 million, of which $3.25 million was previously paid.  Comstock expects to receive net proceeds of approximately $12.5 million from the sale of the LiNiCo facility, plus any remaining proceeds from a $1.5 million hold-back deposited in escrow, for up to 18 months, to cover the cost of any potential environmental remediation items subsequently identified by the buyer.

“The sale of this asset was both opportunistic and strategic since we secured our permitted 200-acre battery metal storage facility in Mound House, Nevada, and recently freed up our existing Storey County operating platform and facilities with the termination of the lease with Tonogold,” stated Mr. Corrado De Gasperis, Comstock’s executive chairman and chief executive officer. “These locations are ideal for storing, piloting, and recycling electronic devices and batteries for clients throughout the electrification supply chain. We are frankly thrilled to turn a $12 million cash obligation into a $12.5 million net cash inflow, resulting in an immediate and nearly $25 million value swing for Comstock shareholders.”

LiNiCo’s lithium-ion battery (“LIB”) storage facility in Mound House resides in one of the largest industrial parks in Lyon County, Nevada, with ample power, water, and immediate highway access. The facility will receive, sort, and store waste LIBs with capacity for expansion and possible crushing, conditioning, and separating operations.  Comstock’s Storey County properties additionally boast a fully permitted mining and metal beneficiation platform that will be ideal for piloting LiNiCo’s crushing, conditioning, and separating infrastructure, and for piloting precursor cathode active material (“PCAM”) recycling and production technology licensed from LiNiCo’s strategic investee and technology partner, Green Li-Ion Pte Ltd.

“The receipt and storage of LIBs represent an essential component of our regional supply chain for recycling these critical metals,” stated Mr. De Gasperis. “We have vast experience operating in both Storey and Lyon County, and their permitting support has been paramount as we continue building a premier, unique, Nevada-based platform necessary for receiving, storing and recycling waste LIBs and electronic devices into the highest quality black mass and high-value electrification products.”

De Gasperis concluded, “Our technologies are designed to meet the practical realities of the existing and rapidly growing LIB recycling demand by enabling profitability at the earliest stages of production. With the highly profitable facility sale behind us, we can now focus on scaling our technologies and pilot operations efficiently, within our existing Nevada infrastructure.”

About Comstock Inc.

Comstock (NYSE: LODE) innovates technologies that contribute to global decarbonization and circularity by efficiently converting under-utilized natural resources into renewable fuels and electrification products that contribute to balancing global uses and emissions of carbon. The Company intends to achieve exponential growth and extraordinary financial, natural, and social gains by building, owning, and operating a fleet of advanced carbon neutral extraction and refining facilities, by selling an array of complementary process solutions and related services, and by licensing selected technologies to qualified strategic partners. To learn more, please visit www.comstock.inc.

Forward-Looking Statements 

This press release and any related calls or discussions may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical facts, are forward-looking statements. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” “plan,” “should,” “intend,” “may,” “will,” “would,” “potential” and similar expressions identify forward-looking statements but are not the exclusive means of doing so. Forward-looking statements include statements about matters such as: future industry market conditions; future explorations or acquisitions; future changes in our exploration activities; future prices and sales of, and demand for, our products; land entitlements and uses; permits; production capacity and operations; operating and overhead costs; future capital expenditures and their impact on us; operational and management changes (including changes in the Board of Directors); changes in business strategies, planning and tactics; future employment and contributions of personnel, including consultants; future land sales; investments, acquisitions, joint ventures, strategic alliances, business combinations, operational, tax, financial and restructuring initiatives, including the nature, timing and accounting for restructuring charges, derivative assets and liabilities and the impact thereof; contingencies; litigation, administrative or arbitration proceedings; environmental compliance and changes in the regulatory environment; offerings, limitations on sales or offering of equity or debt securities, including asset sales and associated costs; and future working capital, costs, revenues, business opportunities, debt levels, cash flows, margins, taxes, earnings and growth. These statements are based on assumptions and assessments made by our management considering their experience and their perception of historical and current trends, current conditions, possible future developments, and other factors they believe to be appropriate. Forward-looking statements are not guarantees, representations or warranties and are subject to risks and uncertainties, many of which are unforeseeable and beyond our control and could cause actual results, developments, and business decisions to differ materially from those contemplated by such forward-looking statements. Some of those risks and uncertainties include the risk factors set forth in our filings with the SEC and the following: adverse effects of climate changes or natural disasters; adverse effects of global or regional pandemic disease spread or other crises; global economic and capital market uncertainties; the speculative nature of gold or mineral exploration, and lithium, nickel and cobalt recycling, including risks of diminishing quantities or grades of qualified resources; metal recycling, processing or mining activities; costs, hazards and uncertainties associated with precious metal based activities, including environmentally friendly and economically enhancing clean mining and processing technologies, precious metal exploration, resource development, economic feasibility assessment and cash generating mineral production; costs, hazards and uncertainties associated with metal recycling, processing or mining activities; contests over our title to properties; potential dilution to our stockholders from our stock issuances, recapitalization and balance sheet restructuring activities; potential inability to comply with applicable government regulations or law; adoption of or changes in legislation or regulations adversely affecting our businesses; permitting constraints or delays; ability to achieve the benefits of business opportunities that may be presented to, or pursued by, us, including those involving battery technology, quantum computing and advanced materials development, and development of cellulosic technology in bio-fuels and related carbon-based material production; ability to successfully identify, finance, complete and integrate acquisitions, joint ventures, strategic alliances, business combinations, asset sales, and investments that we may be party to in the future; changes in the United States or other monetary or fiscal policies or regulations; interruptions in our production capabilities due to capital constraints; equipment failures; fluctuation of prices for gold or certain other commodities (such as silver, zinc, lithium, nickel, cobalt, cyanide, water, diesel, gasoline and alternative fuels and electricity); changes in generally accepted accounting principles; adverse effects of war, mass shooting, terrorism and geopolitical events; potential inability to implement our business strategies; potential inability to grow revenues; potential inability to attract and retain key personnel; interruptions in delivery of critical supplies, equipment and raw materials due to credit or other limitations imposed by vendors; assertion of claims, lawsuits and proceedings against us; potential inability to satisfy debt and lease obligations; potential inability to maintain an effective system of internal controls over financial reporting; potential inability or failure to timely file periodic reports with the Securities and Exchange Commission; potential inability to list our securities on any securities exchange or market or maintain the listing of our securities; and work stoppages or other labor difficulties. Occurrence of such events or circumstances could have a material adverse effect on our business, financial condition, results of operations or cash flows, or the market price of our securities. All subsequent written and oral forward-looking statements by or attributable to us or persons acting on our behalf are expressly qualified in their entirety by these factors. Except as may be required by securities or other law, we undertake no obligation to publicly update or revise any forward-looking statements, whether because of new information, future events, or otherwise.

Neither this press release nor any related calls or discussions constitutes an offer to sell, the solicitation of an offer to buy or a recommendation with respect to any securities of the Company, the fund, or any other issuer.

  Contact information:  
Comstock Inc.
P.O. Box 1118
Virginia City, NV 89440
www.comstock.inc
Corrado De Gasperis
Executive Chairman & CEO
Tel (775) 847-4755
degasperis@comstockinc.com
Zach Spencer
Director of External Relations
Tel (775) 847-5272 Ext.151
questions@comstockinc.com

FAT Brands Inc. (FAT) – A Changing of the Guard


Tuesday, March 07, 2023

FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

Management Change. Yesterday after the market close, FAT Brands announced that its founder and CEO, Andy Wiederhorn, will transition to a new role as an outside consultant and strategic advisor to the Company effective May 5, 2023. Mr. Wiederhorn will remain a FAT Brands Board member and his family office, Fog Cutter Holdings LLC, will continue as the controlling shareholder of FAT Brands. The appointment of an interim CEO will be announced prior to the transition date, and Mr. Wiederhorn will continue as CEO until then.

Drivers. According to the Company, in transitioning from his role as CEO, Mr. Wiederhorn seeks to eliminate the distraction of the previously announced government investigation tied to him, and allow senior management to focus on continuing to drive shareholder value.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Commercial Vehicle Group, Inc. (CVGI) – 4Q22 First Look


Tuesday, March 07, 2023

Joe Gomes, Managing Director – Generalist Analyst, Noble Capital Markets, Inc.

Joshua Zoepfel, Research Associate, Noble Capital Markets, Inc.

Refer to the full report for the price target, fundamental analysis, and rating.

4Q22 Top Line. Revenues were $234.9 million compared to $228.9 million in the prior year period, an increase of 2.6%. The increase in revenues is due to increased pricing to offset material cost increases. Foreign currency translation unfavorably impacted fourth quarter 2022 revenues by $6.3 million, or by 2.7%. New business revenue was approximately $20 million in the quarter, offsetting ongoing softness in the Industrial Automation segment. We had forecast revenue of $249 million.

4Q22 Bottom Line. CVGI reported a net loss of $32.0 million, or $0.98 per diluted share for the quarter, caused by non-cash charges related to tax valuation allowance changes, a pension settlement to terminate the Company’s U.S. legacy pension plan, and a $10.4 million non-cash charge in the Industrial Automation segment due to the modest outlook for the business. Adjusted EPS was $0.04, short of our $0.17 projection. Adjusted EBITDA was $13.3 million, up $0.4 million or 3.1%.


Get the Full Report

Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

CBD – What We Know, What We Don’t, and What We Will

Image Credit: Elsa Olofsson (Flickr)

Here’s What Science Now Says about CBD’s Health Benefits

Over the last five years, an often forgotten piece of U.S. federal legislation – the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill – has ushered in an explosion of interest in the medical potential of cannabis-derived cannabidiol, or CBD.

After decades of debate, the bill made it legal for farmers to grow industrial hemp, a plant rich in CBD. Hemp itself has tremendous value as a cash crop; it’s used to produce biofuel, textiles and animal feed. But the CBD extracted from the hemp plant also has numerous medicinal properties, with the potential to benefit millions through the treatment of seizure disorders, pain or anxiety.

Prior to the bill’s passage, the resistance to legalizing hemp was due to its association with marijuana, its biological cousin. Though hemp and marijuana belong to the same species of plant, Cannabis sativa, they each have a unique chemistry, with very different characteristics and effects. Marijuana possesses tetrahydrocannabinol, or THC, the chemical that produces the characteristic high that is associated with cannabis. Hemp, on the other hand, is a strain of the cannabis plant that contains virtually no THC, and neither it nor the CBD derived from it can produce a high sensation.

This article was republished with permission from The Conversation, a news site dedicated to sharing ideas from academic experts. It represents the research-based findings and thoughts of Kent E Vrana, Professor and Chair of Pharmacology, Penn State.

As a professor and chair of the department of pharmacology at Penn State, I have been following research developments with CBD closely and have seen some promising evidence for its role in treating a broad range of medical conditions.

While there is growing evidence that CBD can help with certain conditions, caution is needed. Rigorous scientific studies are limited, so it is important that the marketing of CBD products does not get out ahead of the research and of robust evidence.

Unpacking the Hype Behind CBD

The primary concern about CBD marketing is that the scientific community is not sure of the best form of CBD to use. CBD can be produced as either a pure compound or a complex mixture of molecules from hemp that constitute CBD oil. CBD can also be formulated as a topical cream or lotion, or as a gummy, capsule or tincture.

Guidance, backed by clinical research, is needed on the best dose and delivery form of CBD for each medical condition. That research is still in progress.

But in the meantime, the siren’s call of the marketplace has sounded and created an environment in which CBD is often hyped as a cure-all – an elixir for insomnia, anxiety, neuropathic pain, cancer and heart disease.

Sadly, there is precious little rigorous scientific evidence to support many of these claims, and much of the existing research has been performed in animal models.

CBD is simply not a panacea for all that ails you.

Childhood Seizure Disorders

Here’s one thing that is known: Based on rigorous trials with hundreds of patients, CBD has been shown to be a proven safe and effective drug for seizure disorders, particularly in children.

In 2018, the U.S. Food and Drug Administration granted regulatory approval for the use of a purified CBD product sold under the brand name Epidiolex for the treatment of Lennox-Gastaut and Dravet syndromes in children.

These two rare syndromes, appearing early in life, produce large numbers of frequent seizures that are resistant to traditional epilepsy treatments. CBD delivered as an oral solution as Epidiolex, however, can produce a significant reduction – greater than 25% – in the frequency of seizures in these children, with 5% of the patients becoming seizure-free.

More than 200 Scientific Trials

CBD is what pharmacologists call a promiscuous drug. That means it could be effective for treating a number of medical conditions. In broad strokes, CBD affects more than one process in the body – a term called polypharmacology – and so could benefit more than one medical condition.

As of early 2023, there are 202 ongoing or completed scientific trials examining the effectiveness of CBD in humans on such diverse disorders as chronic pain, substance use disorders, anxiety and arthritis.

In particular, CBD appears to be an anti-inflammatory agent and analgesic, similar to the functions of aspirin. This means it might be helpful for treating people suffering with inflammatory pain, like arthritis, or headaches and body aches.

CBD also holds potential for use in cancer therapy, although it has not been approved by the FDA for this purpose.

The potential for CBD in the context of cancer is twofold:

First, there is evidence that it can directly kill cancer cells, enhancing the ability of traditional therapies to treat the disease. This is not to say that CBD will replace those traditional therapies; the data is not that compelling.

Second, because of its ability to reduce pain and perhaps anxiety, the addition of CBD to a treatment plan may reduce side effects and increase the quality of life for people with cancer.

The Risks of Unregulated CBD

While prescription CBD is safe when used as directed, other forms of the molecule come with risks. This is especially true for CBD oils. The over-the-counter CBD oil industry is unregulated and not necessarily safe, in that there are no regulatory requirements for monitoring what is in a product.

What’s more, rigorous science does not support the unsubstantiated marketing claims made by many CBD products.

In a 2018 commentary, the author describes the results of his own study, which was published in Dutch (in 2017). His team obtained samples of CBD products from patients and analyzed their content. Virtually none of the 21 samples contained the advertised quantity of CBD; indeed, 13 had little to no CBD at all and many contained significant levels of THC, the compound in marijuana that leads to a high – and that was not supposed to have been present.

In fact, studies have shown that there is little control of the contaminants that may be present in over-the-counter products. The FDA has issued scores of warning letters to companies that market unapproved drugs containing CBD. In spite of the marketing of CBD oils as all-natural, plant-derived products, consumers should be aware of the risks of unknown compounds in their products or unintended interactions with their prescription drugs.

Regulatory guidelines for CBD are sorely lacking. Most recently, in January 2023, the FDA concluded that the existing framework is “not appropriate for CBD” and said it would work with Congress to chart a way forward. In a statement, the agency said that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

As a natural product, CBD is still acting as a drug – much like aspirin, acetaminophen or even a cancer chemotherapy. Health care providers simply need to better understand the risks or benefits.

CBD may interact with the body in ways that are unintended. CBD is eliminated from the body by the same liver enzymes that remove a variety of drugs such as blood thinners, antidepressants and organ transplant drugs. Adding CBD oil to your medication list without consulting a physician could be risky and could interfere with prescription medications.

In an effort to help prevent these unwanted interactions, my colleague Dr. Paul Kocis, a clinical pharmacist, and I have created a free online application called the CANNabinoid Drug Interaction Resource. It identifies how CBD could potentially interact with other prescription medications. And we urge all people to disclose both over-the-counter CBD or recreational or medical marijuana use to their health care providers to prevent undesirable drug interactions.

In the end, I believe that CBD will prove to have a place in people’s medicine cabinets – but not until the medical community has established the right form to take and the right dosage for a given medical condition.

The Original Driver of Inflation has Sailed

Image Credit: Cycling Man (Flickr)

The Supply Chain Part of Inflation Can be Declared Dead, Now What?

New data shows the supply chain is no longer putting meaningful pressure on inflation — will rising prices finally sail off and stay there?  

Historically, the Global Supply Chain Pressure Index (GSCPI) is now on the low side. In fact, for the monthly period ending February 28, it’s below its 25-year average. What’s more, is this is the first time the GSCPI has released a below-average reading of supply chain pressure since August of 2019.

Data Source: NY Federal Reserve

This is significant as the supply-chain issues related to the pandemic, would seem to be transitory and are now no longer the issue. From March 2020 until this more recent report, consumers with easier money available, including stimulus checks, drove demand higher for goods. The suddenness of the onslaught of demand for goods caught the modern world’s “just-in-time” inventory management systems off guard. To make that situation much worse, lockdown policies slowed global production, and shipping and transport became entrenched in gridlock due to undermanned loading docks all under some level of new pandemic processes designed for health and  safety.

Inflation climbed as the price of shipping was bid up substantially, and shortages of products on shelves caused retailers to lessen demand by hiking prices. Some products, particularly new and used cars, experienced sharp price increases as supply chain-related shortages on automotive components such as computer chips and other parts became difficult to obtain.

Will Inflation Finally Recede?

An 18-month-long period of rampant inflation in goods, including vehicles, electronics, food, and sporting goods, (including bicycles for both indoor and outdoor use became unavailable) began to decompress starting in early 2022. The supply chains had slowly worked through the main causes.

Around this same period in 2022, inflation pressures began to build in services. As price hikes for goods lessened or backtracked, the cost for services, including wages, shot up. This is still fueling inflation today.

Often, the fear or expectation of rising prices drives inflation and vice versa. This may be the reason Fed Chairman Powell used the description “transitory” long past the period that it was obvious that inflation was likely persistent. If the Chair of the US Central Bank had suggested back then that we had a long-term problem, the worst of it may have arrived faster and been worse. Conversely, now that higher-than-target inflation is here, it makes sense for Powell to speak more hawkishly, this helps alter expectations of ongoing high rates of inflation.

With inflation primarily coming from services, the medicine for reducing the demand for human services is lessen demand, or even more difficult, increase the labor force. This is a bitter pill for the economy and creates an issue with the Federal Reserve which has two mandates, one to keep inflation modest and the other to maximize employment.

Take Away

The GSCPI is an indicator that the goods-based part of the economy has normalized. Inflation is still raging in services, which are barely tied to services. The hope is that the Fed can reduce the demand for higher and higher wages or perhaps bring more capable workers into the workforce. Another part of this plan may have nothing to do with tightening credit conditions. Talking publicly about being resolved to squash inflation also has an impact on expectations which will reduce the prices charged for service.

The initial battle, the one that kicked off the price hikes (supply chain), has ended, now we have to see how the rest of the Fed’s fight against inflation, both in policy and psychologically, plays out.

Paul Hoffman

Managing Editor, Channelchek

Sources

https://www.house.mi.gov/hfa/PDF/RevenueForecast/NewYorkFed_Global_Supply_Chain_Pressure_Index_Jan2023.pdf

https://www.newyorkfed.org/research/policy/gscpi#/overview

Release – FAT Brands Inc. Founder Andy Wiederhorn to Step Aside as CEO and Transition to Strategic Advisory Role in May 2023

Research News and Market Data on FAT

MARCH 06, 2023

 Veteran Restaurant Executive Will Assume New Position as Outside Consultant and Strategic Advisor

LOS ANGELES, March 06, 2023 (GLOBE NEWSWIRE) — FAT (Fresh. Authentic. Tasty.) Brands Inc. announces that its founder and CEO, Andy Wiederhorn, will transition to a new role as an outside consultant and strategic advisor to the Company effective May 5, 2023. Mr. Wiederhorn will remain a FAT Brands Board member and his family office, Fog Cutter Holdings LLC, will continue as the controlling shareholder of FAT Brands. The appointment of an interim CEO will be announced prior to the transition date, and Mr. Wiederhorn will continue as CEO until then.

In his strategic advisory role, Mr. Wiederhorn will continue to support the management team and the Company while focusing his time on the Company’s long-term strategy and capital allocation plans. In transitioning from his role as CEO, Mr. Wiederhorn seeks to eliminate the distraction of the previously announced government investigation tied to him, and allow senior management to focus on continuing to drive shareholder value.

“While I will be stepping aside as CEO, I will continue to support the growth and evolution of FAT Brands, including championing our talented executive team, which has over the past five years taken the Company from two brands to 17 iconic restaurant brands with over 2,300 units and systemwide sales of $2.2 billion annually,” said FAT Brands CEO Andy Wiederhorn. “In 2022 we were named Public Company of the Year by the Los Angeles Business Journal, due in large part to the hard work and dedication of our corporate teams and franchise partners.”

For more information on FAT Brands, please visit www.fatbrands.com.

About FAT (Fresh. Authentic. Tasty.) Brands
FAT Brands (NASDAQ: FAT) is a leading global franchising company that strategically acquires, markets, and develops fast casual, quick-service, casual dining, and polished casual dining concepts around the world. The Company currently owns 17 restaurant brands: Round Table Pizza, Fatburger, Marble Slab Creamery, Johnny Rockets, Fazoli’s, Twin Peaks, Great American Cookies, Hot Dog on a Stick, Buffalo’s Cafe & Express, Hurricane Grill & Wings, Pretzelmaker, Elevation Burger, Native Grill & Wings, Yalla Mediterranean and Ponderosa and Bonanza Steakhouses, and franchises and owns over 2,300 units worldwide. For more information on FAT Brands, please visit www.fatbrands.com.

MEDIA CONTACT:
Erin Mandzik, FAT Brands
emandzik@fatbrands.com
860-212-6509

Release – CVG Reports Fourth Quarter and Full Year 2022 Results

Research News and Market Data on CVGI

MARCH, 06, 2023

Fourth quarter sales of $235 million, a 2.6% increase year-over-year
Net loss $32.0 million , adjusted EBITDA of $13.3 million, a 3.1% increase in adjusted EBITDA
Continued price realization to offset inflation

Business transformation continues, record annual sales of $982 million
In 2023, Company expects to realize ~$150 million in new business revenue
Strong free cash flow and debt paydown exceeded target at ~$43 million

NEW ALBANY, Ohio, March 06, 2023 (GLOBE NEWSWIRE) — CVG (NASDAQ: CVGI), a diversified industrial products and services company, today announced financial results for its fourth quarter and full year ended December 31, 2022.

Fourth Quarter 2022 Highlights (Compared with prior-year period, where comparisons are noted)

  • Revenue of $234.9 million, up 2.6% as demand and price increases came through as expected. New business revenues fully offsetting softness in Industrial Automation (formerly known as Warehouse Automation). New business revenue was approximately $20 million in the quarter and $130 million for the full year.
  • Net loss of $32.0 million, or $0.98 per diluted share was caused by non-cash charges related to tax valuation allowance changes, a pension settlement to terminate the Company’s U.S. legacy pension plan, and a $10.4 million non-cash charge in Industrial Automation segment due to modest outlook for the business. The Company no longer has a pension liability in the United States.
  • Adjusted EBITDA of $13.3 million, up $0.4 million or 3.1%. Our pricing actions, solid demand, and new business revenues in our three vehicle-related segments are fully offsetting slowdown in the Industrial Automation segment. Startup expenses on new business ramp-ups were high at $3.3 million in the quarter, but set the stage for a much improved 2023.
  • Price negotiations during the quarter secured further increases beginning January 2023.

Full Year 2022 Highlights (Compared with prior-year period, where comparisons are noted)

  • Revenue of $981.6 million, an annual record for the Company driven by the three vehicle segments, current year contribution of new business revenue, and higher prices to offset inflation.
  • Continued to gain new business on a wider spectrum of Non-Class 8 vehicles, with a wider set of customers, and new products. The Company secured an additional $150 million of new business wins during the year; these wins are concentrated in our Electrical Systems product lines. One-time startup costs were expensed as incurred and were $12.3 million in 2022 vs. $6.1 million in 2021.
  • Operating income of $20.1 million, down $29.4 million, and adjusted operating income of $36.6 million, down $16.6 million. The decrease in operating income was due to the lag effect of price recovery on ongoing business and funding a bigger startup program (approximately $6 million higher). The Company’s price recovery efforts are fully offsetting the cost of inflation and have curtailed growth programs tied to high-cost startups.
  • Full-year 2022 debt paydown was $43.2 million, and net debt declined to $120.6 million.

Harold Bevis, President and Chief Executive Officer of CVG, said, “We had a busy quarter of completing a good amount of new business startups, and negotiating substantial improvements in our price recovery program. The Industrial Automation business remains small with a modest outlook, so we took the opportunity to close a plant, right-size our payroll, and right-size our inventory profile.”

“In 2022, we delivered record revenues, had a record amount of new vehicle platform startups, and secured another approximately $150 million of new business wins on an ever-expanding lineup of vehicles. We believe that we can continue to add greater than $100 million of new business wins per year. In 2022, we also exceeded our goal of paying down debt, reduced debt by $43 million and ended the year with $121 million of net debt. We remain focused on higher levels of EBITDA, lower working capital, strategic capex, and lower debt levels.”

“We have already doubled the size of the Electrical Systems business on a pro-forma basis. The secular growth of the Electric Vehicle market is helping us as there is a lot of vehicle development activity globally and we are in an opportunity-rich environment. Our goal is to be known as a nimble, high-service growth company and progressively add new targeted business, concentrated in Electrical Systems.”

“Our transformation plan is working and we are increasing the proportion of our revenues and earnings coming from our Electrical Systems business. Cumulatively, in the last three years, we have secured new growth with 300+ new programs and 115+ new and existing customers.”

“The 2023 cost reduction program is over $30 million, comprised of approximately 350 projects globally. We are committed to lowering our cost structure, mainly in the non-growth areas, and mainly away from high-cost countries. We believe we can accomplish $90 million of cost-outs over the next three years. The Company is also announcing an ESG program of which a primary goal is to reduce its carbon footprint by 50% over the next 10 years.”

“We are expecting 2023 to be a year of record revenue, higher EBITDA, continued free cash flow and debt paydown, $30 million of cost-out, and at least $100 million of targeted new business wins, concentrated in Electrical Systems.”

Andy Cheung, Chief Financial Officer, added, “We delivered another quarter of strong top-line growth and, we have taken major actions to position the Company for strong 2023 performance. We have incurred additional startup costs to support the ramp up of our biggest platforms. Additionally, we made several non-cash GAAP balance sheet adjustments in the quarter, exceeded the high end of our target debt paydown range, and achieved our working capital reduction targets for the year.”

We recorded the following special items during the quarter:

  • We completed the restructuring of the industrial automation business and as a result recognized a non-cash write-down of $10.4 million in industrial automation inventory.
  • As a result of evaluating our global deferred tax assets, we took a net non-cash charge of $14.7 million.
  • We recorded a charge of $8.1 million related to the termination of the Company’s U.S. legacy pension plan.

“Giving effect to the tax adjustments noted above, our actual cash taxes were flat in 2022 versus 2021 at approximately $4.0 million.”

Financial Results
(amounts in millions except per share data and percentages )

Consolidated Results

Fourth Quarter 2022 Results

  • Fourth quarter 2022 revenues were $234.9 million compared to $228.9 million in the prior year period, an increase of 2.6%. The increase in revenues is due to increased pricing to offset material cost increases. Foreign currency translation unfavorably impacted fourth quarter 2022 revenues by $6.3 million, or by 2.7%.
  • Operating loss for the fourth quarter 2022 was $4.0 million compared to operating income of $6.5 million in the prior year period. The decrease in operating income was primarily due to special costs, including restructuring and an inventory write-down due to decreased demand in the Industrial Automation segment. Foreign currency translation also unfavorably impacted fourth quarter 2022 operating loss by $0.9 million. Excluding special costs, the fourth quarter of 2022 adjusted operating income was $8.4 million, down 1.2%. Adjusted operating income includes $1.8 million of higher than expected startup costs on programs which will benefit future periods.
  • Interest expense was $2.9 million and $1.7 million for the fourth quarter ended December 31, 2022 and 2021, respectively. The increase in interest expense was due to higher interest rates, and a higher average debt balance during the fourth quarter 2022 compared to fourth quarter 2021.
  • Net loss was $32.0 million, or $(0.98) per diluted share, for the fourth quarter 2022 compared to net income of $2.6 million, or $0.08 per diluted share, in the prior year period.

At December 31, 2022, the Company had no outstanding borrowings on its revolving credit facility, $31.8 million of cash and $148.8 million availability from the revolving credit facility, resulting in total liquidity of $180.6 million.

Segment Results

Fourth Quarter 2022 Results (Compared with prior-year period, where comparisons are noted)

Vehicle Solutions Segment

  • Revenues were $142.8 million, an increase of 12.9% primarily resulting from material cost pass-through and increased sales volume.
  • Operating income for the fourth quarter 2022 was $3.7 million, a decrease of 26.8%. Primarily due to a lag in price recovery versus cost inflation and higher than planned start up costs. Excluding special costs, the fourth quarter of 2022 adjusted operating income decreased to $4.1 million, or 24.2%, as compared to the fourth quarter 2021.

Electrical Systems Segment

  • Revenues were $47.1 million, an increase of 23.1%, primarily resulting from material cost pass-through and contributions from new business wins.
  • Operating income was $5.4 million, an increase of $3.7 million primarily attributable to material cost pass-through and favorable volume. Adjusted operating income was $5.5 million, an increase of 103.2%, excluding special costs.

Aftermarket and Accessories Segment

  • Revenues were $34.1 million, an increase of 27.8%, primarily resulting from increased sales volume and increased pricing to offset material cost pass-through.
  • Operating income was $3.2 million, an increase of 69.2%. The increase in operating income was primarily attributable to the increase in pricing to offset material cost pass-through.

Industrial Automation Segment

  • Revenues were $11.0 million, a decrease of 70.8%, due to lower demand levels. Operating loss was $11.9 million, compared to operating income of $3.1 million in the prior year. The operating loss was primarily attributable to lower sales volumes and an inventory charge of $10.4 million. Adjusted operating loss was $0.5 million, a decrease of 114.5%. The business restructuring was primarily completed during the quarter.

2023 Outlook

According to ACT Research, 2023 North American Class 8 truck production levels are expected to be at 305,000 units and Class 5-7 production are expected to be at 242,000 units. Estimates from FTR for 2023 are 322,000 units, slightly higher than ACT Research for Class 8 truck builds. The 2022 actual Class 8 truck builds according to the ACT Research was 315,128 units.

According to Interact Analysis, the Global Off-Highway vehicle market is expected to increase approximately 4% to 6.2 million units in 2023 from 5.9 million units in 2022.   Beyond 2023, the Off-Highway vehicle market is expected to grow in the 4-5% range.   We expect our legacy business growth rates to be in line with this outlook.

Industry forecasts are expecting a 4% growth in 2023 for North American aftermarket truck parts. Compounded annual growth of 4.1% is forecasted for 2023-2027​.   ​

GAAP to Non-GAAP Reconciliation

A reconciliation of GAAP to non-GAAP financial measures referenced in this release is included as Appendix A to this release.

Conference Call

A conference call to discuss this press release is scheduled for Tuesday, March 7, 2023, at 10:00 a.m. ET. Management intends to reference the Q4 2022 Earnings Call Presentation during the conference call. To participate, dial (888) 396-8049 using conference code 33489158. International participants dial (416) 764-8646 using conference code 33489158.

This call is being webcast and can be accessed through the “Investors” section of CVG’s website at www.cvgrp.com, where it will be archived for one year.

A telephonic replay of the conference call will be available for a period of two weeks following the call. To access the replay, dial (877) 674-7070 using access code 489158 and international callers can dial (416) 764-8692 using access code 489158.

Company Contact

Andy Cheung
Chief Financial Officer
CVG
IR@cvgrp.com

Investor Relations Contact

Ross Collins or Stephen Poe
Alpha IR Group
CVGI@alpha-ir.com

About CVG

At CVG we deliver real solutions to complex design, engineering and manufacturing problems while creating positive change for our customers, industries, and communities we serve. Information about the Company and its products is available on the internet at www.cvgrp.com.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to risks and uncertainties. These statements often include words such as “believe”, “anticipate”, “plan”, “expect”, “intend”, “will”, “should”, “could”, “would”, “project”, “continue”, “likely”, and similar expressions. In particular, this press release may contain forward-looking statements about the Company’s expectations for future periods with respect to its plans to improve financial results, the future of the Company’s end markets, including the short-term and long-term impact of the COVID-19 pandemic on our business and the global supply chain, changes in the Class 8 and Class 5-7 North America truck build rates, performance of the global construction equipment business, the Company’s prospects in the wire harness, industrial automation and electric vehicle markets, the Company’s initiatives to address customer needs, organic growth, the Company’s strategic plans and plans to focus on certain segments, competition faced by the Company, volatility in and disruption to the global economic environment, including inflation and labor shortages and the Company’s financial position or other financial information. These statements are based on certain assumptions that the Company has made in light of its experience as well as its perspective on historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. Actual results may differ materially from the anticipated results because of certain risks and uncertainties, including those included in the Company’s filings with the SEC. There can be no assurance that statements made in this press release relating to future events will be achieved. The Company undertakes no obligation to update or revise forward-looking statements to reflect changed assumptions, the occurrence of unanticipated events or changes to future operating results over time. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on behalf of the Company are expressly qualified in their entirety by such cautionary statements.

Use of Non-GAAP Measures

This earnings release contains financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). In general, the non-GAAP measures exclude items that (i) management believes reflect the Company’s multi-year corporate activities; or (ii) relate to activities or actions that may have occurred over multiple or in prior periods without predictable trends. Management uses these non-GAAP financial measures internally to evaluate the Company’s performance, engage in financial and operational planning and to determine incentive compensation.

Management provides these non-GAAP financial measures to investors as supplemental metrics to assist readers in assessing the effects of items and events on the Company’s financial and operating results and in comparing the Company’s performance to that of its competitors and to comparable reporting periods. The non-GAAP financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.

The non-GAAP financial measures disclosed by the Company should not be considered a substitute for, or superior to, financial measures calculated in accordance with GAAP. The financial results calculated in accordance with GAAP and reconciliations to those financial statements set forth above should be carefully evaluated.

Source: Commercial Vehicle Group, Inc.

Release – Ocugen Appoints Quan A. Vu To Chief Financial Officer & Chief Business Officer

Research News and Market Data on OCGN

March 6, 2023

MALVERN, Pa., March 06, 2023 (GLOBE NEWSWIRE) — Ocugen, Inc. (Ocugen or the Company) (NASDAQ: OCGN), a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines, today announced the appointment of Quan A. Vu to Chief Financial Officer & Chief Business Officer.

“Quan has quickly become a tremendous asset for Ocugen and his comprehensive healthcare and financial expertise is providing valuable insight toward reaching our corporate goals,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “With Quan now overseeing both finance and business development, there will be a fully integrated approach to financial strategy—pursuing new partnerships and engaging with the investment community.”

Mr. Vu joined Ocugen on February 1, 2023, and has been working closely across multiple, key corporate functions—understanding short- and long-term business and financial needs of the Company along with the potential of its differentiated scientific platforms. With his additional appointment as Chief Financial Officer, and aside from his management and oversight of the finance and accounting functions, Mr. Vu will partner closely with Dr. Musunuri to enhance the Company’s forward-looking, value-additive financial initiatives by leveraging the Company’s anticipated clinical milestone achievements to bolster fundamental shareholder composition, expand interactions with the investor community, and ensure reputable capital markets and equity research support.

“I am excited about this new role and the ability to work alongside the leadership team to advance Ocugen at such a pivotal time,” said Mr. Vu. “We will continue to work collaboratively to position the Company for future success.”

Before joining Ocugen, Mr. Vu was most recently Chief Operating Officer/Chief Business Officer for 180 Life Sciences. He began his career in healthcare investment banking at both Morgan Stanley and Goldman Sachs, and then held leadership roles of increasing responsibility at Opiant Pharmaceuticals, Impax Laboratories, Anthem, and Amgen. Mr. Vu obtained his BA in Economics from UCLA, graduating summa cum laude with College Honors and Economics Departmental Honors. He is also a Certified Treasury Professional (inactive).

About Ocugen, Inc.
Ocugen, Inc. is a biotechnology company focused on discovering, developing, and commercializing novel gene and cell therapies, biologics, and vaccines that improve health and offer hope for patients across the globe. We are making an impact on patient’s lives through courageous innovation—forging new scientific paths that harness our unique intellectual and human capital. Our breakthrough modifier gene therapy platform has the potential to treat multiple retinal diseases with a single product, and we are advancing research in infectious diseases to support public health and orthopedic diseases to address unmet medical needs.

Discover more at  and follow us on Twitter and LinkedIn.

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, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations. These and other risks and uncertainties are more fully described in our periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.

Contact:

Tiffany Hamilton
Head of Communications
IR@ocugen.com