Independence Holding Company Announces 2021 Second-Quarter and Six-Month Results

STAMFORD, Conn., Aug. 09, 2021 (GLOBE NEWSWIRE) — Independence Holding Company (NYSE: IHC) today reported 2021 second-quarter and six-month results.   


Financial Results

Net income attributable to IHC of $76,471,000 or $5.22 per share for the three months ended June 30, 2021 compared to $421,000 or $.03 per share, diluted, for the three months ended June 30, 2020.   Net income attributable to IHC was $82,092,000 or $5.61 per share, diluted, for the six months ended June 30, 2021 compared to $4,699,000 or $.32 per share, diluted, for the six months ended June 30, 2020.  

The Company entered into three transactions this year for the sales of Madison National Life Insurance Company, Inc. (“Madison National Life”) to Horace Mann Educators Corporation, Standard Security Life Insurance Company of New York (“Standard Security Life”) to Reliance Standard Life Insurance Company and 70% of its pet business, including all of the common stock of Independence American Insurance Company and 85% of the common stock of PetPartners, Inc. (“PetPartners”), to Iguana Capital, Inc. (“Iguana Capital”).

The Company completed the sale of PetPartners on June 30, 2021, and results for the three months and six months of 2021 include a gain on the sale of PetPartners of $62,693,000 net of tax. Also included in income from discontinued operations is certain income from Standard Security Life and Independence American Insurance Company. The results of Madison National Life will be shown as discontinued operations in the third quarter. The gain on the sale of Standard Security Life, Independence American Insurance Company and Madison National Life will be recorded when those transactions receive regulatory approval and are consummated.


Chief Executive Officer’s Comments

Roy T. K. Thung, Chief Executive Officer, commented, “We are very pleased with the three transactions we entered into this year, and the consummation of the sales is expected to take most of the focus of the Company for the remainder of 2021. After all the transactions are closed, IHC projects that it will hold approximately $560 million in cash and investments, net of liabilities; a 30% interest in Iguana Capital carried at $115 million; and our health insurance agency and other assets with an aggregate carrying value of approximately $20 million, resulting in an estimated book value of approximately $47.00 per share which is calculated as if the transactions occurred and were recorded on June 30, 2021. Actual book value per share at June 30, 2021 was $37.45. These projections are based on information currently known to management and include the use of estimates and assumptions with regards to anticipated transaction costs, estimated tax rates and other potential changes.”

Mr. Thung added, “We intend to invest, develop and expand our agency operations into a much larger and profitable operation. As we progress, our agency operations will be centered around INSXcloud.com (INSX), our CMS approved Web Broker. INSX provides an agent with the ability to quote, directly enroll and track applications on the Federally Facilitated Marketplace, plus much more. The balance of our agency includes our W-2 Call Centers and our captive independent Advisors unit, both of which sell into the under/over age 65 health insurance markets, as well as our Independence Brokerage Group which recruits independent agents and agencies to sell via our platforms and contracts. We are refocusing a portion of our over 65 division into the under 65 market in order to take advantage of the positioning of INSX, our agency and our lead generation capabilities, and the market growth resulting from the American Rescue Plan Act. Although these operations have been unprofitable, we expect these changes will improve the results and bring us to profitability in the future. In addition, we will also continue to monitor and support our minority interest investment in Iguana Capital.”


About The IHC Group

Independence Holding Company (NYSE: IHC), through our current subsidiaries, underwrites and distributes health, group disability and life, New York State DBL and paid family leave, and pet insurance. IHC underwrites policies in all 50 states, Washington D.C., Puerto Rico and the U.S. Virgin Islands through our three carriers: Independence American Insurance Company, Standard Security Life Insurance Company of New York (“Standard Security Life”) and Madison National Life Insurance Company, Inc. (“Madison National Life”). We also distribute products nationally through multiple channels, including our agencies, call centers, advisors, direct and affinity relationships, Web Broker, and web properties, including www.healthedeals.com; www.healthinsurance.org; www.medicareresources.org; www.petplace.com; and www.inxscloud.com. As previously announced, IHC has entered into stock purchase agreements to sell all of the issued and outstanding capital stock of Standard Security Life, Madison National Life and Independence American Holdings Corp., which includes Independence American Insurance Company and other assets of IHC’s pet business, each subject to regulatory approval. To learn more, visit https://ihcgroup.com/.


Forward-looking Statements

Certain statements and information contained in this release may be considered “forward-looking statements,” such as statements relating to management’s views with respect to future events and financial performance. Such forward-looking statements are subject to risks, uncertainties and other factors that could cause actual results to differ materially from historical experience or from future results expressed or implied by such forward-looking statements.  Potential risks and uncertainties include, but are not limited to, economic conditions in the markets in which IHC operates, new federal or state governmental regulation, IHC’s ability to effectively operate, integrate and leverage any past or future strategic acquisition, and other factors which can be found in IHC’s other news releases and filings with the Securities and Exchange Commission. IHC expressly disclaims any duty to update its forward-looking statements unless required by applicable law.

 
INDEPENDENCE HOLDING COMPANY
 
CONDENSED CONSOLIDATED STATEMENTS OF INCOME

June 30, 2021

(In Thousands, Except Shares and Per Share Data)
 
 
 
    Three Months Ended   Six Months Ended
    June 30,   June 30,
    2021
  2020
  2021
  2020
REVENUES:                
Premiums earned $ 42,451   $ 49,138   $ 86,023   $ 99,804  
Net investment income   1,651     2,329     3,452     4,828  
Fee income   4,944     3,907     11,079     7,341  
Other income   410     807     1,026     1,432  
Net investment gains (losses)   (126 )   274     91     117  
                 
    49,330     56,455     101,671     113,522  
                 
EXPENSES:                
Insurance benefits, claims and reserves   17,192     21,339     39,113     47,628  
Selling, general and administrative expenses   32,842     37,974     63,602     69,034  
                 
    50,034     59,313     102,715     116,662  
                 
Loss from continuing operations before income taxes   (704 )   (2,858 )   (1,044 )   (3,140 )
Income tax benefit   (267 )   (1,066 )   (430 )   (1,187 )
                 
Loss from continuing operations, net of tax   (437 )   (1,792 )   (614 )   (1,953 )
                 
Discontinued operations:                
Total pretax income from discontinued operations   92,375     3,594     99,574     9,243  
Income tax expense on discontinued operations   15,570     1,264     17,026     2,430  
Income from discontinued operations, net of tax   76,805     2,330     82,548     6,813  
                 
Net income   76,368     538     81,934     4,860  
(Income) loss from nonredeemable noncontrolling interests   1     (43 )   2     (34 )
(Income) loss from redeemable noncontrolling interests   102     (74 )   156     (127 )
                 
NET INCOME ATTRIBUTABLE TO IHC $ 76,471   $ 421   $ 82,092   $ 4,699  
                 
Basic income per common share                
Loss from continuing operations $ (.03 ) $ (.12 ) $ (.04 ) $ (.13 )
Income from discontinued operations   5.25     .15     5.65     .45  
Basic income per common share $ 5.22   $ .03   $ 5.61   $ .32  
                 
WEIGHTED AVERAGE SHARES OUTSTANDING   14,642     14,765     14,641     14,811  
                 
Diluted income per common share                
Loss from continuing operations $ (.03 ) $ (.12 ) $ (.04 ) $ (.13 )
Income from discontinued operations   5.25     .15     5.65     .45  
Diluted income per common share $ 5.22   $ .03   $ 5.61   $ .32  
                 
WEIGHTED AVERAGE DILUTED SHARES OUTSTANDING   14,642     14,765     14,641     14,811  
                 

As of August 7, 2021, there were 14,644,389 common shares outstanding, net of treasury shares.

 
INDEPENDENCE HOLDING COMPANY
 
CONDENSED CONSOLIDATED BALANCE SHEETS

(In Thousands)
 
 
 
      June 30, 2021     December 31, 2020
             
ASSETS:            
Investments:            
Short-term investments   $ 1,550     $ 1,568  
Securities purchased under agreements to resell     70,323       33,038  
Fixed maturities, available-for-sale     183,709       210,719  
Equity securities           1,753  
Other investments     2,022       1,928  
Total investments     257,604       249,006  
             
Cash and cash equivalents     22,834       31,923  
Investment in Iguana Capital, Inc.     33,762        
Due and unpaid premiums     10,950       9,981  
Due from reinsurers     354,735       357,237  
Goodwill     12,486       12,486  
Funds held in escrow     78,779        
Other assets     29,864       46,832  
Assets attributable to discontinued operations     416,162       375,691  
             
TOTAL ASSETS   $ 1,217,176     $ 1,083,156  
             
LIABILITIES AND EQUITY:            
LIABILITIES:            
Policy benefits and claims   $ 127,815     $ 132,957  
Future policy benefits     196,026       198,086  
Funds on deposit     142,155       141,376  
Unearned premiums     1,763       1,952  
Other policyholders’ funds     11,988       12,001  
Due to reinsurers     2,242       3,872  
Accounts payable, accruals and other liabilities     66,519       44,855  
Liabilities attributable to discontinued operations     120,180       75,939  
             
TOTAL LIABILITIES     668,688       611,038  
             
Commitments and contingencies            
Redeemable noncontrolling interest           2,312  
             
STOCKHOLDERS’ EQUITY:            
Preferred stock (none issued)            
Common Stock     18,625       18,625  
Paid-in capital     125,653       124,757  
Accumulated other comprehensive income     3,220       4,197  
Treasury stock, at cost     (77,189 )     (77,088 )
Retained earnings     478,139       399,273  
             
TOTAL IHC STOCKHOLDERS’ EQUITY     548,448       469,764  
NONREDEEMABLE NONCONTROLLING INTERESTS     40       42  
             
TOTAL EQUITY     548,488       469,806  
             
TOTAL LIABILITIES AND EQUITY   $ 1,217,176     $ 1,083,156  
                 

CONTACT: Loan Nisser
(646) 509-2107
www.IHCGroup.com
 



Leafly To Go Public Through Business Combination With Merida Merger Corp I

Transaction Enables Leafly to Execute Growth Strategy and Expand Leading Content-First, Community-Driven Cannabis Discovery Marketplace

Leafly is Well Positioned to Capitalize on Accelerating Legalization Trends Across North America

CEO Yoko Miyashita and Current Management Team will Continue to Lead the Company Post-Closing

Existing Shareholders to Roll 100% of Their Existing Stake into the Combined Company

PR Newswire

SEATTLE and NEW YORK, Aug. 9, 2021 /PRNewswire/ — Leafly Holdings Inc. (“Leafly”), the world’s leading online cannabis discovery marketplace and resource for cannabis consumers, and Merida Merger Corp. I (NASDAQ: MCMJ) (“Merida”), a special purpose acquisition company sponsored by Merida Capital Holdings, today announced that they have entered into a definitive agreement with respect to a business combination. Upon completion of the proposed transaction, Merida will adopt the Leafly name and its common stock is expected to be listed on the NASDAQ under the ticker symbol LFLY. The transaction values the combined company at an implied, fully diluted enterprise value of approximately $385 million and equity value of approximately $532 million, subject to any redemptions by Merida stockholders.

Based in Seattle, Washington, Leafly is a content-first, community-driven, three-sided marketplace that attracts the world’s largest cannabis audience. Across its website and mobile app, Leafly empowers a highly engaged audience of more than 125 million annual visitors to understand, select, and reserve cannabis products from licensed retailers.

Leafly provides a subscription-based platform for more than 7,800 brands and 4,600 paying retail subscribers. Approximately 55% of North American retail licensees are currently subscribed to its marketplace and advertising services. As a non-plant touching platform with leading brand recognition, a user-friendly experience, and an established position in core growth markets, Leafly is well positioned to capitalize on accelerating legalization trends and e-commerce adoption across North America.

Yoko Miyashita, Chief Executive Officer of Leafly, said, “For the past decade, we have focused on building a unique, legally compliant marketplace with an equal emphasis on educating consumers and enabling them to reserve cannabis products from legal, reputable providers. With this transaction, we are looking forward to entering the next phase of our company’s journey – creating more personalized consumer experiences, driving more value to our retail partners, amplifying brands on our platform, and further scaling our presence in local markets as legalization continues. Our consumers recognize Leafly as one of the most trusted brands in cannabis, and we do not take that trust for granted. We are excited to partner with Merida’s deeply experienced team to create even more value for our consumers, partners and shareholders.”

Peter Lee, President of Merida Merger Corp. I, commented, “Merida Capital is very excited to be involved in this transformative event for Leafly. We have seen firsthand how consumers respond to Leafly’s innovative technology and proprietary insights. Leafly has a proven flywheel and clear and achievable growth plans, and we look forward to leveraging our team’s demonstrated track record with other high growth ancillary cannabis companies to support their transition to the public market.”

Leafly Investment Highlights

Merida believes the proposed transaction with Leafly presents an attractive investment opportunity for shareholders for a number of reasons, including:

Shoppers, retailers, and brands trust Leafly to make cannabis understandable and accessible:

  • Leafly has developed the most extensive content library in the cannabis market, attracting the largest audience in cannabis
  • The cannabis community relies on Leafly’s strain database (5,000+ strains), cannabis coverage (11,000+ articles), and user reviews (1.3MM+ reviews) to navigate the highly complex and evolving world of cannabis

Community-driven, three-sided marketplace with retailers, brands, and high-value shoppers:

  • Leafly’s audience of 10 million monthly unique visitors connects with over 4,600 licensed stores across North America
  • The company generates subscription and advertising revenue from licensed retailers and brands

A flexible platform that scales and sits at the center of the $19 billion rapidly growing legal cannabis market:

  • The cannabis market is large and expanding rapidly with states continuing to legalize as a result of broad support for legalization
  • Consumers use Leafly to learn about cannabis, the cannabis industry, and cannabis politics before their states legalize, giving Leafly a head start

As consumer ordering shifts online, Leafly helps consumers navigate a complicated industry:

  • Markets are evolving to the right supply/demand dynamics to enable the cannabis e-commerce market, a trend which was accelerated by COVID
  • Leafly garners consumer trust through its strong focus on compliance and by helping consumers navigate dynamic regulatory environments

Leafly is at an inflection point to accelerate growth and monetization:

  • Poised to accelerate retailer monetization with retailers seeing 14x Return on Ad Spend and in the early stages of monetizing the more than 7,800 brands on the Leafly platform
  • Projected revenue of approximately $43 million in 2021E and $65 million in 2022E, representing ~52% annual growth with gross margins of ~88% as Leafly further penetrates current markets and capitalizes on its strong position in the newly legalized East Coast

Key Transaction Terms

At closing, the combined company is expected to have an implied, fully diluted enterprise value of approximately $385 million and equity value of approximately $532 million, subject to any redemptions by Merida stockholders. Existing Leafly shareholders will roll 100% of their existing stake in Leafly and, upon closing, are expected to own approximately 72% of the combined company on a pro forma basis, assuming the company receives 100% of the proceeds currently held in trust.

The transaction is expected to generate proceeds of up to $161.5 million, subject to any redemptions by Merida stockholders. This follows and is inclusive of Leafly’s recent $31.5 million capital raise led by leading cannabis-focused investors, including Merida Capital Holdings, Delta Emerald Ventures, SOJE Capital, and Leafly’s existing shareholder base. The proceeds of the capital raise and transaction provide Leafly with substantial capital to enhance its advertising and platform technology, expand its marketplace, and execute customer acquisition initiatives.

The proposed transaction has been unanimously approved by the boards of directors of both Leafly and Merida, and is expected to close in the 4th quarter of 2021, subject to customary closing conditions.

Additional information about the transaction, including a copy of the investor presentation that will be used by the parties to describe the transaction during the conference call discussed below, will be provided in a Current Report on Form 8-K to be filed by Merida with the Securities and Exchange Commission (“SEC”) and available at www.sec.gov.

Advisors

Oppenheimer & Co. served as exclusive financial advisor to Leafly, while Weil, Gotshal & Manges LLP served as Leafly’s legal advisor. EarlyBirdCapital, Inc. served as financial advisor to Merida. Craig-Hallum Capital Group LLC, JMP Securities, LLC, and The Benchmark Company, LLC are serving as capital markets advisors to Merida. Graubard Miller acted as Merida’s legal advisor.

About Leafly

Leafly helps more than 125 million annual visitors discover cannabis each year. Our powerful tools help shoppers make informed purchasing decisions and empower cannabis businesses to attract and retain loyal customers through advertising and technology services. Learn more at Leafly.com or download the Leafly mobile app through Apple’s App Store or Google Play.

About Merida Merger Corp. I

Merida Merger Corp. I is a blank check company formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or other similar business combination with one or more businesses or entities.

Webcast Information

An audio-only webcast regarding the proposed merger will take place at 10:00 a.m. ET today, August 9, 2021. The pre-recorded audio call may be accessed by navigating to www.netroadshow.com/nrs/home/#!/?show=a693ae94.

A more detailed investor webcast with slides can be accessed now by visiting www.netroadshow.com/nrs/home/#!/?show=ffdf47e5. This webcast, press release, and investor presentation are available at investor.leafly.com.

Additional Information and Where to Find It

In connection with the proposed business combination contemplated by the Agreement and Plan of Merger by and among Merida, Merida Merger Sub, Inc., Merida Merger Sub II, LLC, and Leafly (the “Merger Agreement”), Merida intends to file a registration statement on Form S-4 (the “Registration Statement“) that will include a proxy statement of Merida, a prospectus of Merida and a consent solicitation statement of Leafly. The proxy statement/prospectus/consent solicitation statement will be sent to all Merida and Leafly stockholders as of a record date to be established for voting on the proposed business combination and the other matters to be voted upon at a meeting of Merida’s stockholders to be held to approve the proposed business combination and other matters (the “Special Meeting“). Merida may also file other documents regarding the proposed business combination with the SEC. The definitive proxy statement/prospectus/consent solicitation statement will contain important information about the proposed business combination and the other matters to be voted upon at the Special Meeting and is not intended to provide the basis for any investment decision or any other decision in respect of such matters. Before making any voting decision, investors and security holders of the Merida and Leafly are urged to read the Registration Statement, the proxy statement/prospectus/consent solicitation statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed business combination as they become available because they will contain important information about the proposed business combination and related matters.

Investors and security holders will be able to obtain free copies of the proxy statement/prospectus/consent solicitation statement and all other relevant documents filed or that will be filed with the SEC by Merida through the website maintained by the SEC at www.sec.gov.

Participants in Solicitation

Merida and Leafly and their respective directors and officers may be deemed to be participants in the solicitation of proxies from Merida’s stockholders in connection with the proposed business combination. Information about Merida’s directors and executive officers and their ownership of Merida’s securities is set forth in Merida’s filings with the SEC. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed business combination may be obtained by reading the proxy statement/prospectus/consent solicitation statement regarding the proposed business combination when it becomes available. You may obtain free copies of these documents as described in the preceding paragraph.

Forward-Looking Statements

This document contains certain forward-looking statements within the meaning of the federal securities laws with respect to the proposed business combination between Merida and Leafly, including statements regarding the benefits of the proposed business combination, the anticipated timing of the proposed business combination, the services offered by Leafly and the markets in which Leafly operates, business strategies, debt levels, industry environment, potential growth opportunities, the effects of regulations and Merida’s or Leafly’s projected future results. These forward-looking statements generally are identified by the words “believe,” “project,” “expect,” “anticipate,” “estimate,” “intend,” “strategy,” “future,” “forecast,” “opportunity,” “plan,” “may,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” and similar expressions (including the negative versions of such words or expressions).

Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this document, including but not limited to: (i) the risk that the proposed business combination may not be completed in a timely manner or at all, which may adversely affect the price of Merida’s securities; (ii) the risk that the proposed business combination may not be completed by Merida’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by Merida; (iii) the failure to satisfy the conditions to the consummation of the proposed business combination, including the approval of the proposed business combination by Merida’s stockholders, the satisfaction of the minimum trust account amount following redemptions by Merida’s public stockholders and the receipt of certain governmental and regulatory approvals; (iv) the effect of the announcement or pendency of the proposed business combination on Merida’s or Leafly’s business relationships, performance, and business generally; (v) risks that the proposed business combination disrupts current plans of Leafly and potential difficulties in Leafly employee retention as a result of the proposed business combination; (vi) the outcome of any legal proceedings that may be instituted against Merida or Leafly related to the Merger Agreement or the proposed business combination; (vii) the ability to maintain the listing of Merida’s securities on the NASDAQ; (viii) the price of Merida’s securities, including volatility resulting from changes in the competitive and highly regulated industry in which Leafly plans to operate, variations in performance across competitors, changes in laws and regulations affecting Leafly’s business and changes in the combined capital structure; and (ix) the ability to implement business plans, forecasts, and other expectations after the completion of the proposed business combination, and identify and realize additional opportunities. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties that will be described in the Company’s final proxy statement/prospectus/consent solicitation statement contained in the Registration Statement, including those under “Risk Factors” therein, and other documents filed by Merida from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and Merida and Leafly assume no obligation and, except as required by law, do not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise. Neither Merida nor Leafly gives any assurance that either Merida or Leafly will achieve its expectations.

Disclaimer

This document relates to a proposed business combination between Merida and Leafly. This document does not constitute an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

Contacts

Media

Laura Morarity


[email protected]

206-489-8427

Molly Morse / Nick Capuano
[email protected] / [email protected]
917-603-4142 / 917-842-7859

Investors

Chris Hollenbeck

[email protected]

 

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SOURCE Leafly

Umpqua Holdings Announces $0.21 Per Common Share Dividend

PR Newswire

PORTLAND, Ore., Aug 9, 2021 /PRNewswire/ — Umpqua Holdings Corporation (NASDAQ: UMPQ) today announced that its Board of Directors has approved a quarterly cash dividend in the amount of $0.21 per common share.  The dividend is payable on August 31, 2021, to shareholders of record as of August 20, 2021.

About Umpqua Holdings Corporation

Umpqua Holdings Corporation (NASDAQ: UMPQ) is the parent company of Umpqua Bank, an Oregon-based community bank recognized for its entrepreneurial approach, innovative customer experience, and distinctive banking solutions. Umpqua Bank has locations across Oregon, Washington, California, Idaho and Nevada.  Umpqua Holdings Corporation is headquartered in Portland, Oregon. For more information, visit umpquabank.com.

 

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SOURCE Umpqua Holdings Corporation

Hill International Selected to Continue Capital Program Administration Services for the City of Philadelphia’s Capital Program at Philadelphia International Airport

PHILADELPHIA, Aug. 09, 2021 (GLOBE NEWSWIRE) — Hill International, Inc. (NYSE:HIL), delivering the infrastructure of change, announced today it was selected by the City of Philadelphia, Division of Aviation, to provide Capital Program Administration support services for the City’s ongoing Capital Program at Philadelphia International Airport (PHL). Hill has supported PHL’s Capital Program for more than 20 years, helping to manage and implement budgets, deliver cost efficiencies, maximize investments, and advance the City’s diversity goals.

Hill’s services under the new contract will encompass end-to-end Capital Program services by assisting and managing the implementation of Capital projects. This includes capital budget development and implementation; financial governance and oversight; grants management services; program management system development and maintenance; capital development support; purchasing and maintenance support. Through these and other as-needed services, the Hill team will help PHL efficiently manage the Capital Program and realize cost savings wherever possible. The Hill team currently assigned to the PHL Capital Program will remain largely in-place, offering continuity and proven expertise.

“As travel resumes post-COVID-19 restrictions, airports are seeing a corresponding return to air travel, and PHL is no exception,” explains Hill International Senior Program Manager Satheesh Raja, PMP. “PHL did an outstanding job during the pandemic of protecting passengers and staff and is ready now to ramp up the Capital Program. Our team will continue to provide the oversight and support PHL to make sure their passenger and cargo projects are executed as planned and as cost-effectively as possible.”

Hill Chief Executive Officer Raouf Ghali adds, “It’s exciting to see air travel recovering at PHL in particular and around the world in general. The success of PHL’s Capital Program is a testament to Hill’s management capabilities, and reflective of the trust our aviation clients have in our teams.”   

About Hill International

Hill International, with more than 2,800 professionals in 72 offices worldwide, provides program management, project management, construction management, facilities management, and other consulting services to clients in a variety of market sectors. Engineering News-Record magazine recently ranked Hill as one of the largest construction management firm in the United States. For more information on Hill, please visit our website at www.hillintl.com.

Forward Looking Statements

Certain statements contained herein may be considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, and it is our intent that any such statements be protected by the safe harbor created thereby. Except for historical information, the matters set forth herein including, but not limited to, any statements of belief or intent, any statements concerning our plans, strategies, and objectives for future operations are forward-looking statements. These forward-looking statements are based on our current expectations, estimates and assumptions and are subject to certain risks and uncertainties. Although we believe that the expectations, estimates, and assumptions reflected in our forward-looking statements are reasonable, actual results could differ materially from those projected or assumed in any of our forward-looking statements. Important factors that could cause our actual results to differ materially from estimates or projections contained in our forward-looking statements are set forth in the Risk Factors section and elsewhere in the reports we have filed with the Securities and Exchange Commission, including that unfavorable global economic conditions may adversely impact our business, our backlog may not be fully realized as revenue, and our expenses may be higher than anticipated. We do not intend, and undertake no obligation, to update any forward-looking statement.

Hill International, Inc.

Elizabeth J. Zipf, LEED AP BD+C
Senior Vice President
(215) 309-7707
[email protected]

The Equity Group, Inc.

Devin Sullivan
Senior Vice President
(212) 836-9608
[email protected]



Hemisphere Media Group Announces Second Quarter 2021 Financial Results

Pantaya Grows to Nearly 1 million Subscribers

PR Newswire

MIAMI, Aug. 9, 2021 /PRNewswire/ — Hemisphere Media Group, Inc. (NASDAQ: HMTV) (“Hemisphere” or the “Company”), the only publicly traded pure-play U.S. media company targeting the high growth U.S. Hispanic and Latin American markets with leading broadcast and cable television and digital content platforms, today announced financial results for the second quarter ended June 30, 2021.

President and Chief Executive Officer of Hemisphere, Alan Sokol, said “Our business continues to fire on all cylinders as we experienced yet another great quarter of growth. Importantly, we experienced strong advertising growth over 2019, which speaks to the power of our channels, content and fast-growing audience, as well as our ability to execute our stated strategy.

“Pantaya is demonstrating strong results, and as of quarter end, we had close to 1 million subscribers. We are proud of the subscriber increases we have experienced in just the first quarter since our acquisition, and are incredibly excited about our upcoming pipeline of original content. With our compelling and unique lineup of originally produced series and movies, we are confident we will continue to drive accelerated subscriber growth.  We have already seen strong growth from the promotional synergies offered by the Hemisphere networks, including Pantaya’s rise to the #1 position on Android among entertainment apps in Puerto Rico as of July 31, ahead of Netflix, Disney+ and HBOMax.

“The Puerto Rican economy is stronger than it has been in years, with great metrics for both business trends and consumer activity, and we expect this growth to continue, with major public projects funded by federal aid expected to commence in 2022. WAPA continues to be the clear ratings and advertising leader by a wide margin.

“We are also excited to announce that we have signed a distribution agreement with YouTube TV for carriage of Pantaya, Cinelatino, Pasiones and WAPA America, with an anticipated launch prior to year-end.

“I am incredibly proud of our performance, and I’d like to thank all of our employees, audiences, and partners. We had a very strong first half of the year, and have strong momentum heading into the second half of 2021.”

Financial Results for the Three and Six Months Ended June 30, 2021

Net revenues were $50.5 million for the three months ended June 30, 2021, an increase of 45%, as compared to $34.7 million for the same period in 2020. Net revenues were $88.0 million for the six months ended June 30, 2021, an increase of 31%, as compared to $67.1 million for the same period in 2020. The increases in both periods were due to growth in both subscriber and advertising revenue. For the three- and six-month periods, subscriber revenue increased $12.9 million, or 67%, and $13.1 million, or 33%, respectively, primarily due to the inclusion of Pantaya, which the Company acquired on March 31, 2021, as well as contractual rate increases and new launches of our networks, offset in part by a decline in U.S. cable subscribers. For the three- and six-month periods, advertising revenue increased $4.9 million, or 40%, and $9.0 million, or 37%, respectively, primarily due to growth in the Puerto Rico television advertising market, coupled with an increase in WAPA’s share of the market, as well as an increase in advertising revenue at our cable networks. For the three- and six-month periods, other revenue decreased $2.1 million, or 69%, and $1.1 million, or 30%, respectively, driven primarily by the timing of the licensing of content.

Operating expenses were $43.3 million for the three months ended June 30, 2021, an increase of 68%, as compared to operating expenses of $25.8 million for the same period in 2020. Operating expenses were $75.8 million for the six months ended June 30, 2021, an increase of 40%, as compared to operating expenses of $54.1 million for the same period in 2020. The increases were primarily due to the inclusion of Pantaya, as well as higher advertising sales commissions due to higher advertising revenue, increased depreciation and amortization expense and costs incurred in connection with the acquisition of Pantaya. Additionally, the prior year periods reflected cost reductions as a result of the pandemic, including the postponement or cancellation of certain programming and sporting events, as well as voluntary salary reductions and employee retention credits that we did not have in the current year periods.

Net loss attributable to Hemisphere Media Group, Inc. was $6.3 million for the three months ended June 30, 2021, as compared to a net loss of $6.7 million for the same period in 2020. Net income was $27.1 million for the six months ended June 30, 2021, as compared to a net loss of $16.1 million for the same period in 2020. The increase for the six-month period was primarily due to a $30.1 million one-time non-cash gain recognized on the existing 25% equity interest in Pantaya upon the step acquisition of the remaining 75% equity interest on March 31, 2021.

Adjusted EBITDA was $12.3 million for the three months ended June 30, 2021, a decrease of 8%, as compared to Adjusted EBITDA of $13.3 million for the same period in 2020. Adjusted EBITDA was $28.0 million for the six months ended June 30, 2021, an increase of 13%, as compared to Adjusted EBITDA of $24.8 million for the same period in 2020.

As of June 30, 2021, the Company had $253.6 million in debt and $72.4 million of cash. The Company’s gross leverage ratio was approximately 3.8x, and net leverage ratio was approximately 2.7x, which reflects Pantaya’s operating results as of the acquisition date.

The following tables set forth the Company’s financial performance for the three and six months ended June 30, 2021 and 2020, as well as select financial data as of June 30, 2021 and December 31, 2020:


HEMISPHERE MEDIA GROUP, INC. 

Comparison of Consolidated Operating Results      

(amounts in thousands)    


Three Months Ended June 30,


Six Months Ended June 30,


2021


2020


2021


2020

(Unaudited)

(Unaudited)


Net revenues


$     50,460


$     34,735


$       88,037


$      67,144


Operating expenses:

Cost of revenues

14,798

12,560

26,577

23,527

Selling, general and administrative

24,908

10,208

36,299

21,441

Depreciation and amortization

4,337

2,794

7,002

5,925

Other expenses

1,363

27

8,091

3,048

(Gain) loss from FCC spectrum repack and other

(2,124)

182

(2,176)

173

Total operating expenses

43,282

25,771

75,793

54,114

Operating income

7,178

8,964

12,244

13,030

Other (expense) income:

Interest expense and other, net

(3,165)

(2,496)

(5,523)

(5,282)

(Loss) gain on equity method investment activity

(8,569)

(10,189)

24,040

(17,208)

Impairment of equity method investment

(5,479)

Other expense, net

(668)

              Total other (expense) income

(11,734)

(12,685)

17,849

(27,969)

             (Loss) income before income taxes

(4,556)

(3,721)

30,093

(14,939)

Income tax expense

(1,785)

(2,884)

(3,053)

(1,209)


Net (loss) income


$       (6,341)


$     (6,605)


$      27,040


$   (16,148)

Net loss (income) attributable to noncontrolling interests

55

(77)

32

38


  Net (loss) income attributable to Hemisphere Media Group, Inc.


$       (6,286)


$       (6,682)


$       27,072


$   (16,110)


Reconciliation of net (loss) income attributable to Hemisphere Media Group, Inc. to Adjusted EBITDA:

  Net (loss) income attributable to Hemisphere Media Group, Inc.


$      (6,286)


$       (6,682)


$    (27,072)


$   (16,110)

Add (Deduct):

Net (loss) income attributable to noncontrolling interests

(55)

77

(32)

(38)

Income tax expense

1,785

2,884

3,053

1,209

Other expense, net

668

Impairment of equity method investment

5,479

Loss (gain) on equity method investment activity

8,569

10,189

(24,040)

17,208

Interest expense and other, net

3,165

2,496

5,523

5,282

(Gain) loss from FCC spectrum repack and other

(2,124)

182

(2,176)

173

Transaction and non-recurring expenses

1,372

27

8,100

3,048

Depreciation and amortization

4,337

2,794

7,002

5,925

Stock-based compensation

1,490

1,356

2,795

2,636


Adjusted EBITDA


$       12,253


$       13,323


$       27,965


$      24,812

 



Selected Financial Data:

(amounts in thousands)


As of


As of


June 30, 2021


December 31, 2020

(Unaudited)

(Audited)

Cash

$72,439

$134,471

Debt (a)

$253,646

$204,813

Leverage ratio (b):

3.8x

3.2x

Net leverage ratio (c):

2.7x

1.1x

(a)

Represents the aggregate principal amount of the debt.

(b)

Represents the sum of gross debt divided by Adjusted EBITDA for the last twelve months, including Pantaya’s operating results as of the acquisition date.

(c)

Represents gross debt less cash divided by Adjusted EBITDA for the last twelve months, including Pantaya’s operating results as of the acquisition date. This ratio differs from the calculation contained in the Company’s amended term loan.

The following table presents estimated cable television subscriber information (unaudited):


Subscribers (a)


(amounts in thousands)


June 30, 2021


December 31, 2020


June 30, 2020



U.S. Cable Networks:

WAPA America (b)

3,448

3,672

3,847

Cinelatino

3,648

3,822

3,958

Pasiones

3,879

4,125

4,278

Centroamerica TV

3,343

3,468

3,598

Television Dominicana

2,246

2,178

2,213


Total


16,564


17,265


17,894



Latin America Cable Networks:

Cinelatino

13,968

14,096

14,081

Pasiones

15,522

14,250

13,935


Total


29,490


28,346


28,016

(a)

Amounts presented are based on most recent remittances received from our Distributors as of the respective dates shown above, which are typically two months prior to the dates shown above.

(b)

Excludes digital basic subscribers.

Non-GAAP Reconciliations

Within Hemisphere’s second quarter 2021 press release, Hemisphere makes reference to the non-GAAP financial measure, “Adjusted EBITDA.” Whenever such information is presented, Hemisphere has complied with the provisions of the rules under Regulation G and Item 2.02 of Form 8-K. When presenting Adjusted EBITDA, Hemisphere’s management adds back (deducts) from net (loss) income attributable to Hemisphere Media Group, Inc., net (loss) income attributable to non-controlling interest, depreciation expense, amortization of intangibles, (gain) loss from FCC spectrum repack and other, other expense, net, loss (gain) on equity method investment activity, interest expense and other, net, impairment charges, transaction and non-recurring expenses, income tax expense, and stock-based compensation. The specific reasons why Hemisphere’s management believes that the presentation of this non-GAAP financial measure provides useful information to investors regarding Hemisphere’s financial condition, results of its operations and cash flows has been provided in the Form 8-K filed in connection with this press release. A reconciliation of net (loss) income attributable to Hemisphere Media Group, Inc. to Adjusted EBITDA can be found above in the table that sets forth Hemisphere’s financial performance for the three and six months ended June 31, 2021 and 2020.

Conference
Call

Hemisphere will conduct a conference call to discuss its second quarter 2021 results at 10:00 AM ET on Monday, August 9, 2021. A live broadcast of the conference call will be available online via the Company’s Investor Relations website located at www.hemispheretv.com. Alternatively, interested parties can access the conference call by dialing (833) 952-1501, or from outside the United States at (236) 714-2110, at least five minutes prior to the start time. The conference ID for the call is 9608079.

A replay of the call will be available beginning at approximately 1:00 PM ET on Monday, August 9, 2021 by dialing (800) 585-8367, or from outside the United States by dialing (416) 621-4642. The conference ID for the replay is 9608079.

Forward-Looking Statements

Statements in this press release and oral statements made from time to time by representatives of Hemisphere may contain certain statements that are “forward-looking statements”  within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that are made pursuant to the safe harbor provisions of the Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding the impact of the acquisition of Pantaya on the Company’s business and financial performance, Pantaya’s subscriber growth prospects, the Company’s business plans, and the U.S. Hispanic population growth. Without limitation, any statements preceded or followed by or that include the words “targets,” “plans,” “believes,” “expects,” “intends,” “will,” “likely,” “may,” “anticipates,” “estimates,” “projects,” “should,” “would,” “could,” “might,” “expect,” “positioned,” “strategy,” “future,” or words, phrases or terms of similar substance or the negative thereof, are forward-looking statements. Forward-looking statements are neither historical facts nor assurances of future performance. These forward-looking statements are subject to change, and actual results may materially differ from those set forth in this press release due to certain risks and uncertainties. Factors that could cause or contribute to changes in such forward-looking statements include, but are not limited to deterioration of general economic conditions, political instability, social unrest, and public health crises, such as the occurrence of a global pandemic like COVID-19, either nationally or in the local markets in which Hemisphere operates, Puerto Rico’s uncertain political climate, as well as delays in the disbursement of earmarked federal funds on the local economy and advertising market, the effects of extreme weather and climate events on Hemisphere’s business as well as Hemisphere’s counterparties, customers, employees, third-party vendors and suppliers, changes in the distribution and viewing of television programming, including the expanded deployment of personal video recorders, subscription and advertising video on demand, internet protocol television, mobile personal devices and personal tablets and their impact on advertising and affiliate revenue, short and long-term migration shifts in Puerto Rico, Hemisphere’s ability to timely and fully recover proceeds under our insurance policies and Hemisphere’s ability to successfully integrate acquired assets, in particular, Pantaya, and achieve anticipated synergies, statements relating to Hemisphere’s future financial and operating results (including growth and earnings), plans, objectives, expectations and intentions and other statements that are not historical facts. . The foregoing review of important factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements set forth in Hemisphere’s reports filed with the Securities and Exchange Commission (“SEC”), including Hemisphere’s quarterly reports on Form 10-Q and its annual report on Form 10-K. If one or more of these factors materialize, or if any underlying assumptions prove incorrect, Hemisphere’s actual results, performance, or achievements may vary materially from any future results, performance or achievements expressed or implied by these forward-looking statements. We may also be faced with unforeseen risks and uncertainties related to Pantaya’s business. Additionally, many of these risks are currently amplified by and may, in the future, continue to be amplified by the prolonged impact of the COVID-19 pandemic. Forward-looking statements included herein are made as of the date hereof, and Hemisphere undertakes no obligation to update publicly such statements to reflect subsequent events or circumstances.

About Hemisphere Media Group, Inc.

Hemisphere Media Group, Inc. (HMTV) is the only publicly traded pure-play U.S. media company targeting the high-growth U.S. Hispanic and Latin American markets with leading television, streaming and digital content platforms. Headquartered in Miami, Florida, Hemisphere owns and operates five leading U.S. Hispanic cable networks, two Latin American cable networks, the leading broadcast television network in Puerto Rico, the leading Spanish-language subscription streaming service in the U.S., a Spanish-language content distribution company and has an ownership interest in a leading broadcast television network in Colombia.


Contact:

Edelman Financial Communications for Hemisphere Media Group
Danielle O’Brien
917-444-6325
[email protected]

 

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SOURCE Hemisphere Media Group, Inc.

Sexton Biotechnologies to be Acquired by Biolife Solutions

Innovative tools provider for the cell and gene therapy industry to accelerate their journey creating tools for tomorrow’s therapies

PR Newswire

INDIANAPOLIS, Aug. 9, 2021 /PRNewswire/ — Sexton Biotechnologies, a provider of novel manufacturing solutions for the cell and gene therapy (CGT) industry, today announced that it has entered into a definitive agreement whereby BioLife Solutions (NASDAQ: BLFS) will acquire all outstanding shares of the company in a deal worth a total value of $30 million. During the past two years, Sexton has worked to provide end-to-end solutions for emerging cell and gene therapy manufacturers. The merger with BioLife will expand Sexton’s ability to meet market demands for their innovative tools such as CellSeal® cryogenic storage vials, the Signata CT-5, the industry’s first flexible, semi-automated fluid handling system, along with industry leading human platelet lysate growth supplements.

The past two years, Sexton has worked to provide end-to-end solutions for emerging cell and gene therapy manufacturers.

In two years, the Sexton team has launched multiple new products and experienced significant revenue growth. “With the guidance and support of our investors, the Sexton team has executed to reach our development and growth milestones,” said Sean Werner, PhD, President of Sexton Biotechnologies who will become BioLife’s Chief Technology Officer – Cell Processing Platform. “The team is focused on providing high quality, innovative tools to our customers so that their life saving therapies can be more robust, reliable, and ultimately, cost effective. We’re excited about the opportunities to better support our mission by joining the BioLife family and can’t imagine a better home for our team members and technologies.”

Sexton currently supports CGT manufacturing with two product lines; processing and handling solutions, and cell performance supplements. Initially focused on cryogenic storage, the products have expanded to provide solutions from cell expansion through cryopreservation. The proprietary CellSeal® storage container is the first final product vial designed specifically for cell therapy to be used as a final container of an FDA approved product. The Signata CT-5 flexible fluid handling system is designed to easily integrate with other leading tools in the industry to improve fill and finish as well as automating the varied manual fluid movement techniques of cell culture. With a range of platelet lysate growth supplements, Stemulate®, nLiven®, and T-Liven, Sexton’s cell performance platform allows manufacturers of both MSCs and immune-oncology products to expand cells in a non-xenogenic culture supplement with demonstrated phenotypic improvement.

Mike Rice, BioLife CEO, noted, “As a significant shareholder of Sexton since their spinout from Cook Regentec in 2019, we’ve been closely following Sean Werner and the Sexton team’s great execution and progress. The business is at an inflection point and their products are highly complementary to our portfolio, enabling BioLife to strengthen relationships with our marquee base of cell and gene therapy developers. We welcome the Sexton team to BioLife and look forward to leveraging our respective strengths to accelerate growth across our platforms.”

Steven Thompson, PhD, Vice President of Sales and Product Development of Sexton Biotechnologies, remarked, “We are excited for this next chapter as part of BioLife. Our solutions are making a real impact in the industry, and we think this is just the beginning of their potential. Joining with BioLife provides us with a clear path for increasing product adoption while giving us an opportunity to continue innovating to build additional tools that will benefit the industry for years to come.”

ABOUT SEXTON BIOTECHNOLOGIES

Sexton Biotechnologies is a revenue stage, biotechnology company focused on the development and sales of bioproduction tools for cell and gene therapy founded in 2019 as a spin out of Cook Regentec, a life science incubator/accelerator located in Indianapolis, IN. Sexton develops purpose-built CGT tools and media to enable flexible automation and scaling of cell manufacturing processes to increase the probability of positive clinical outcomes and reduce time-to-market, failure points, and labor costs. Sexton’s portfolio includes the CellSeal platform of cryo-storage tools and fill/finish systems and human platelet lysate growth supplements. More information at www.sextonbiotechnologies.com.

About BioLife Solutions

BioLife Solutions is a leading supplier of cell and gene therapy bioproduction products and services. Our portfolio includes our proprietary CryoStor® freeze media and HypoThermosol®shipping and storage media, ThawSTAR® family of automated, water-free thawing products, evo® cold chain management system, Custom Biogenic Systems® high-capacity cryogenic freezers, Stirling Ultracold ULT freezers, and SciSafe biologic materials storage. For more information, please visit www.biolifesolutions.com, www.savsu.com, www.custombiogenics.com, www.scisafe.com, www.stirlingultracold.com, www.sextonbio.com and follow BioLife on Twitter.


For media contacts

Dusty Howe

[email protected]

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SOURCE Sexton Biotechnologies

Orbital Energy Group’s Subsidiary, Orbital Solar Services, Awarded 130-Megawatt Project

PR Newswire

HOUSTON, Aug. 9, 2021 /PRNewswire/ — Orbital Energy Group, Inc. (NASDAQ: OEG) (“Orbital”), today announced that its wholly-owned subsidiary, Orbital Solar Services (“OSS”), a leader in utility-scale solar power generation facilities, has been awarded an Engineering, Procurement, and Construction (“EPC”) contract (the “Contract”) to construct a 132.2MWdc/100MWac solar farm in the Southeastern United States.

The Contract calls for OSS to design, engineer, and produce a utility-scale solar array to be delivered in early 2022. Under the Contract terms, OSS will provide full utility-scale EPC services, including substation construction.  The project will consist of 350,000 solar panels installed across 800 acres of land and will provide power for 20,000 homes per year.

OSS was selected based on its in-house engineering capabilities, supply chain relationships and proven track record of having executed more than 40 solar projects over 600 megawatts.  OSS is a well-recognized industry leader with over 50 years combined experience in the delivery and management of both commercial and renewable energy construction projects. 

Brandon Martin, OSS’s CEO, stated, “This second project with an industry-leading, energy company, evidences OSS’s growing reputation for its technical expertise and abilities in designing and building these large, complex, utility-scale solar projects. We look forward to commencing work on this project and continuing our relationship with this large-scale energy producer.”

“We are thrilled by this project award, showcasing Orbital’s ability to provide services that contribute to reducing our nation’s carbon footprint,” said Jim O’Neil, Orbital Energy Group’s Vice-Chairman & CEO. “This project and others like it serve to expand OSS’s industry relationships based on a solid record of achievement, and the expertise to provide end-to-end solutions. By expanding relationships, as we have with this customer, we are positioning OEG and OSS to increase their presence in the renewable and alternative energy marketplace during the balance of 2021 and beyond.”

About Orbital Energy Group

Orbital Energy Group, Inc. [Nasdaq: OEG] is creating a diversified energy services platform through the acquisition and development of innovative companies. Orbital Energy’s group of businesses includes Orbital Power Services, Orbital Solar Services, Orbital Telecom Services and Orbital Gas Systems.

Orbital Power Services provides engineering, construction, maintenance and emergency response solutions to the power, utilities and midstream markets.

Orbital Solar Services provides engineering, procurement and construction (“EPC”) expertise in the renewable energy industry and established relationships with solar developers and panel manufacturers in the utility scale solar market.

Orbital Telecom Services, operating as Gibson Technical Services, has nationwide locations equipped to effectively support multi-vendor OEM technology environments and outside plant construction operations on an as-needed basis with specialized services in broadband, wireless, outside plant and building technologies, including healthcare.

Orbital Gas Systems is a 30-year leader in innovative gas solutions, serving the energy, power and processing markets through the design, installation and commissioning of industrial gas sampling, measurement and delivery systems.

As a publicly traded company, Orbital Energy is dedicated to maximizing shareholder value. But most important, our commitment to conduct business with a high level of integrity, respect, and philanthropic dedication allows the organization to make a difference in the lives of their customers, employees, investors and global community.

For more information please visit: www.orbitalenergygroup.com 

Important Cautions Regarding Forward Looking Statements

This document contains 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. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The Company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, our reliance on third-party manufacturers and suppliers, government agency budgetary and political constraints, new or increased competition, changes in market demand, and the performance or reliability of our products. These factors and others could cause operating results to vary significantly from those in prior periods, and those projected in forward-looking statements. Additional information regarding these and other factors, which could materially affect the Company and its operations, are included in certain forms the Company has filed with the Securities and Exchange Commission.

Investor Relations:
KCSA Strategic Communications
David Hanover
T: 212-896-1220
[email protected]      

 

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SOURCE Orbital Energy Group, Inc.

Harmony Biosciences Acquires Asset With Novel Mechanism Of Action For The Potential Treatment Of Narcolepsy And Other Rare Neurological Diseases

Acquisition represents the first step in Harmony’s plan to build a robust portfolio of products to treat patients living with rare neurological diseases who have significant unmet medical needs

PR Newswire

PLYMOUTH MEETING, Pa., Aug. 9, 2021 /PRNewswire/ — Harmony Biosciences Holdings, Inc. (“Harmony”) (Nasdaq: HRMY), a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients living with rare neurological diseases, today announced the acquisition of HBS-102 (formerly CSTI-100), a potential first-in-class molecule with a novel mechanism of action, from ConSynance Therapeutics, Inc., a clinical stage biotechnology company focused on rare central nervous system diseases. Under the terms of the agreement, Harmony will acquire full development and commercialization rights globally, with the exception of Greater China, with financial terms including an upfront payment of $3.5 million and potential development and regulatory milestone payments and royalties.

“The acquisition of HBS-102 represents our first addition to the pipeline beyond WAKIX® (pitolisant), and our intention is to continue to pursue additional assets in line with our vision of becoming a leading rare neurological disease company with a robust portfolio of products,” said John C. Jacobs, President and Chief Executive Officer of Harmony.

HBS-102 is a Melanin Concentrating Hormone Receptor 1 (MCHR1) antagonist that has the potential to offer a novel approach to the treatment of narcolepsy including the symptoms of Rapid Eye Movement (REM) sleep dysregulation, such as cataplexy, hallucinations and sleep paralysis. HBS-102 blocks the activity of melanin concentrating hormone (MCH) neurons, which scientific evidence indicates is the generator of REM sleep and its associated behaviors. Therefore, HBS-102 could potentially reduce REM intrusions into wakefulness and reduce the frequency of cataplexy, hallucinations, and sleep paralysis. In a preclinical proof-of-concept study, Dr. Thomas Scammell, Professor, Department of Neurology, Beth Israel Deaconess Medical Center and Division of Sleep Medicine, Harvard Medical School, and his team demonstrated that an MCHR1 antagonist molecule resulted in a significant reduction in cataplexy events in an orexin knockout mouse model of narcolepsy.1 Harmony will complete additional work to prepare and submit an Investigational New Drug (IND) application with the plan to initiate a Phase 2 clinical trial once the IND is open.

“Similar to WAKIX, this asset offers Harmony another opportunity to lead with the science and potentially bring another first-in-class treatment option to patients living with narcolepsy and other rare neurological diseases,” said Jeffrey Dayno, M.D., Chief Medical Officer of Harmony. “The majority of people living with narcolepsy experience symptoms of REM dysregulation that have a significant impact on their lives. The acquisition and successful development of HBS-102 could represent a next-generation therapy for narcolepsy patients by offering a novel approach, directly targeting the control center for REM sleep and its associated behaviors.”

About Narcolepsy   
Narcolepsy is a rare, chronic, debilitating neurological disease of sleep-wake state instability that impacts approximately 165,000 Americans and is primarily characterized by excessive daytime sleepiness (EDS) and cataplexy – its two cardinal symptoms – along with other manifestations of REM sleep dysregulation (hallucinations and sleep paralysis), which intrude into wakefulness. EDS is the inability to stay awake and alert during the day and is the symptom that is present in all people living with narcolepsy. In most patients, narcolepsy is caused by the loss of hypocretin/orexin, a neuropeptide in the brain that supports sleep-wake state stability. This disease affects men and women equally, with typical symptom onset in adolescence or young adulthood; however, it can take up to a decade to be properly diagnosed.  

About WAKIX® (pitolisant) Tablets

WAKIX, a first-in-class medication, is approved by the U.S. Food and Drug Administration for the treatment of excessive daytime sleepiness or cataplexy in adult patients with narcolepsy. WAKIX has been commercially available in the U.S. since Q4 2019. It was granted orphan drug designation for the treatment of narcolepsy in 2010, and breakthrough therapy designation for the treatment of cataplexy in 2018. WAKIX is a selective histamine 3 (H3) receptor antagonist/inverse agonist. The mechanism of action of WAKIX is unclear; however, its efficacy could be mediated through its activity at H3 receptors, thereby increasing the synthesis and release of histamine, a wake promoting neurotransmitter. WAKIX was designed and developed by Bioprojet (France). Harmony has an exclusive license from Bioprojet to develop, manufacture and commercialize pitolisant in the United States. 

Important Safety Information

WAKIX is contraindicated in patients with known hypersensitivity to pitolisant or any component of the formulation and in patients with severe hepatic impairment. WAKIX is extensively metabolized by the liver and there is a significant increase in WAKIX exposure in patients with moderate impairment.

WAKIX prolongs the QT interval. Avoid use of WAKIX in patients with known QT prolongation or in combination with other drugs known to prolong the QT interval. Avoid use of WAKIX in patients with a history of cardiac arrhythmias, as well as other circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death, including symptomatic bradycardia, hypokalemia or hypomagnesemia, and the presence of congenital prolongation of the QT interval.

The risk of QT prolongation may be greater in patients with hepatic or renal impairment due to higher concentrations of pitolisant; monitor these patients for increased QTc. Dosage modification is recommended in patients with moderate hepatic impairment and moderate or severe renal impairment. WAKIX is not recommended in patients with end-stage renal disease (ESRD).

In the placebo-controlled clinical trials conducted in patients with narcolepsy with or without cataplexy, the most common adverse reactions (≥5% and twice placebo) for WAKIX were insomnia (6%), nausea (6%), and anxiety (5%). Other adverse reactions that occurred at ≥2% and more frequently than in patients treated with placebo included headache, upper respiratory infection, musculoskeletal pain, heart rate increased, hallucinations, irritability, abdominal pain, sleep disturbance, decreased appetite, cataplexy, dry mouth, and rash.

Please see the Full Prescribing Information for WAKIX for more information.

About HBS-102
HBS-102 is an investigational compound being developed as a potential treatment for narcolepsy and other rare neurological diseases. HBS-102 is a potential first-in-class molecule with a novel mechanism of action which targets melanin concentrating hormone (MCH) neurons in the hypothalamus, which make up the control center for REM sleep and related behaviors. In the setting of orexin deficiency (as occurs in patients with type 1 narcolepsy), there is an imbalance between orexin and MCH which could result in the control center for REM sleep going unchecked that could lead to REM sleep intruding into wakefulness. If that occurs, the clinical symptoms are experienced as cataplexy, hallucinations, and/or sleep paralysis. HBS-102, an MCHR1 antagonist, blocks the activity of the MCH neurons, which could potentially reduce REM intrusions into wakefulness and therefore reduce the debilitating symptoms of cataplexy, hallucinations and sleep paralysis.

About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company headquartered in Plymouth Meeting, PA. The Company was established by Paragon Biosciences, LLC, with a vision to provide novel treatment options for people living with rare neurological diseases who have unmet medical needs. For more information on Harmony, please visit the company’s website: www.harmonybiosciences.com.

About ConSynance
ConSynance Therapeutics is a clinical-stage, biopharmaceutical company targeting rare central nervous system diseases. The Company focuses on innovative therapeutics for rare hypothalamic disorders including narcolepsy, Prader-Willi Syndrome and hypothalamic injury-induced obesity. For more information on ConSynance, please visit the company’s website:  www.consynance.com.

Forward Looking Statement 
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our product WAKIX. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of WAKIX, pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreement with Bioprojet; the availability of favorable insurance coverage and reimbursement for WAKIX; the impact of the COVID-19 pandemic; the timing of and our ability to obtain regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; our ability to identify additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; and the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony’s common stock may be volatile and fluctuate substantially; significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 25, 2021, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. 

Harmony Biosciences Media Contact: 
Nancy Leone 
215-891-6046 
[email protected] 

Harmony Biosciences Investor Contact: 
Lisa Caperelli 
484-539-9736 
[email protected] 

1 Naganuma, F., Bandaru, S. S., Absi, G., Mahoney, C. E., Scammell, T. E., & Vetrivelan, R. (2018). Melanin-concentrating hormone neurons contribute to dysregulation of rapid eye movement sleep in narcolepsy. Neurobiology of Disease, 120, 12-20. https://doi.org/10.1016/j.nbd.2018.08.012

 

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SOURCE Harmony Biosciences

TRACON Pharmaceuticals Announces Results of Second Independent Data Monitoring Committee Review of Safety Data from ENVASARC Pivotal Trial

– Trial to Continue as Planned

SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) —  TRACON Pharmaceuticals (NASDAQ: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., today announced that the Independent Data Monitoring Committee for the ENVASARC pivotal trial has recommended that the trial proceed as planned following the review of 12 week safety data from more than 20 patients enrolled into the trial as of May 2021. The safety data reviewed included data from more than 10 patients enrolled into cohort A of treatment with single agent envafolimab and more than 10 patients enrolled into cohort B of treatment with envafolimab and Yervoy (ipilimumab).

“Envafolimab continues to be well tolerated as a single agent and when combined with Yervoy in refractory sarcoma patients who are enrolled in the ENVASARC trial. We remain on track for the Independent Data Monitoring Committee to review interim efficacy data in the fourth quarter of this year,” said James Freddo, M.D., TRACON’s Chief Medical Officer.

About Envafolimab

Envafolimab (KN035), a novel, single-domain antibody against PD-L1, is the first subcutaneously injected PD-(L)1 inhibitor to be studied in pivotal trials. Envafolimab is currently being studied in the ENVASARC Phase 2 pivotal trial in the U.S. sponsored by TRACON, has been studied in a completed Phase 2 pivotal trial as a single agent in MSI-H/dMMR advanced solid tumor patients in China and is being studied in an ongoing Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China, with both Chinese trials sponsored by 3D Medicines. TRACON’s partners Alphamab Oncology and 3D Medicines submitted an NDA to the NMPA in China for envafolimab in MSI-H/dMMR cancer that was accepted for review in December 2020 and granted priority review in January 2021. In the Phase 2 MSI-H/dMMR advanced solid tumor trial, the confirmed objective response rate (ORR) by blinded independent central review in MSI-H/dMMR colorectal cancer (CRC) patients treated with envafolimab who failed a fluoropyrimidine, oxaliplatin and irinotecan was 32%, which was similar to the 28% confirmed ORR reported in the Opdivo package insert in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin, and irinotecan and the 33% confirmed ORR reported for Keytruda in MSI-H/dMMR CRC patients who failed a fluoropyrimidine, oxaliplatin and irinotecan in cohort A of the KEYNOTE-164 clinical trial.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at approximately 25 top cancer centers in the United States that began dosing in December 2020. TRACON expects the trial to enroll 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into cohort A of treatment with single agent envafolimab and 80 patients enrolled into cohort B of treatment with envafolimab and Yervoy. The primary endpoint is ORR by blinded independent central review with duration of response a key secondary endpoint.

About TRACON

TRACON develops targeted therapies for cancer utilizing a capital efficient, CRO independent, product development platform. The Company’s clinical-stage pipeline includes: Envafolimab, a PD-L1 single-domain antibody given by rapid subcutaneous injection that is being studied in the pivotal ENVASARC trial for sarcoma; TRC102, a Phase 2 small molecule drug candidate for the treatment of lung cancer; and TJ004309, a CD73 antibody in Phase 1 development for the treatment of advanced solid tumors. TRACON is actively seeking additional corporate partnerships whereby it leads U.S. regulatory and clinical development and shares in the cost and risk of clinical development and leads U.S. commercialization.  In these partnerships TRACON believes it can serve as a solution for companies without clinical and commercial capabilities in the U.S.  To learn more about TRACON and its product pipeline, visit TRACON’s website at www.traconpharma.com.

Forward-Looking Statements

Statements made in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding TRACON’s plans to further develop product candidates, expectations regarding the timing and scope of clinical trials, availability of clinical data and future reviews of data by the Independent Data Monitoring Committee, expected development and regulatory milestones and timing thereof, the potential benefits of product candidates, and TRACON’s business development strategy and goals to enter into additional collaborations. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include: risks associated with clinical development; whether TRACON or others will be able to complete or initiate clinical trials on TRACON’s expected timelines, if at all, including due to risks associated with the COVID-19 pandemic or other pandemics; the fact that future clinical results may not be consistent with preliminary results or results from prior studies; the fact that TRACON has limited control over whether or when third party collaborators complete on-going trials, initiate additional trials or seek regulatory approval of TRACON’s product candidates; the fact that TRACON’s collaboration agreements are subject to early termination; whether TRACON will be able to enter into additional collaboration agreements on favorable terms or at all; potential changes in regulatory requirements in the United States and foreign countries; TRACON’s reliance on third parties for the development of its product candidates, including the conduct of its clinical trials and manufacture of its product candidates; whether TRACON will be able to obtain additional financing; and other risks described in TRACON’s filings with the Securities and Exchange Commission under the heading “Risk Factors”. All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. TRACON undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Company Contact: Investor Contact:
Mark Wiggins Brian Ritchie
Chief Business Officer LifeSci Advisors LLC
(858) 251-3492 (212) 915-2578
[email protected] [email protected]



Metacrine to Present at 2021 Canaccord Genuity Growth Conference

SAN DIEGO, Aug. 09, 2021 (GLOBE NEWSWIRE) — Metacrine, Inc. (NASDAQ:MTCR), a clinical-stage biopharmaceutical company pioneering differentiated therapies for patients with liver and gastrointestinal diseases, today announced that Preston Klassen, M.D., MHS, president and chief executive officer, will present virtually at the 2021 Canaccord Genuity Growth Conference at 12:30 p.m. ET on Thursday, August 12, 2021.

A live webcast of the presentation will be available at https://investors.metacrine.com/events-and-presentations.   A replay of the webcast will be archived for 90 days following the conference.  

About Metacrine

Metacrine, Inc. is a clinical-stage biopharmaceutical company building a pipeline of differentiated therapies to treat liver and gastrointestinal diseases. Metacrine has developed a proprietary farnesoid X receptor (FXR) platform utilizing a unique chemical scaffold, which has demonstrated an improved therapeutic profile in clinical trials. The Company’s two product candidates, MET409 and MET642, are currently being investigated in clinical trials as potential new treatments for NASH. MET409 has completed a 12-week monotherapy trial in patients with NASH and is being evaluated in a 12-week combination trial with empagliflozin in patients with both NASH and type 2 diabetes. MET642 has completed a 14-day Phase 1 trial in healthy volunteers and is being evaluated in a 16-week monotherapy trial in patients with NASH. To learn more, visit www.metacrine.com.



Investor & Media Contact
Steve Kunszabo        
Metacrine, Inc.
+1 (858) 369-7892
[email protected]