FDA Approved Vapes are coming!

FDA announces ‘first authorization’ for marketing of e-cigarette products

The U.S. Food and Drug Administration announced it has authorized the marketing of three new tobacco products, which it noted marks “the first set of electronic nicotine delivery system products ever to be authorized by the FDA through the Premarket Tobacco Product Application – PMTA – pathway.”

The FDA issued marketing granted orders to R.J. Reynolds Vapor Company, a subsidiary of British American Tobacco, for its Vuse Solo closed ENDS device and accompanying tobacco-flavored e-liquid pods, specifically, Vuse Solo Power Unit, Vuse Replacement Cartridge Original 4.8% G1, and Vuse Replacement Cartridge Original 4.8% G2.

“As the RJR Vapor Company submitted data to the FDA that demonstrated that marketing of these products is appropriate for the protection of public health, today’s authorization allows these products to be legally sold in the U.S.,” the FDA stated.

Solar Powered Vuse

Today, the FDA also issued 10 marketing denial orders for flavored ENDS products submitted under the Vuse Solo brand by RJR.

“Due to potential confidential commercial information issues, the FDA is not publicly disclosing the specific flavored products. These products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. Should any of them already be on the market, they must be removed from the market or risk enforcement. Retailers should contact RJR with any questions about products in their inventory.

The agency is still evaluating the company’s application for menthol-flavored products under the Vuse Solo brand,” the FDA stated.

“Today’s authorizations are an important step toward ensuring all new tobacco products undergo the FDA’s robust, scientific premarket evaluation. The manufacturer’s data demonstrates its tobacco-flavored products could benefit addicted adult smokers who switch to these products – either completely or with a significant reduction in cigarette consumption – by reducing their exposure to harmful chemicals. We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization,” said Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products.

Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products

Shares to watch: BTI, MO, PM.

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Spectrum Brands shares soar on sale of it’s division

Spectrum Brands agrees to sell Hardware & Home Improvement segment for $4.3B

Spectrum Brands Holdings (SPB) announced it has entered into a definitive agreement to sell its HHI segment to ASSA ABLOY (ASAZY) for $4.3B in cash, which it said represents over 14 times HHI’s expected FY21 Adjusted EBITDA.

Upon closing of the transaction, Spectrum Brands expects to receive approximately $3.5B in net proceeds, subject to final tax calculations and purchase price adjustments.

Spectrum Brands expects to use the proceeds from this transaction to repay debt and reduce its gross leverage ratio to approximately 2.5x times in the near term.

Excess proceeds are expected to be allocated to invest for organic growth, fund complementary acquisitions and return capital to shareholders.

The company expects to maintain its quarterly cash dividend of 42c per common share, which will be subject to the company’s continued review from time to time.

The sale of HHI is expected to close following the receipt of certain regulatory approvals and customary closing conditions.

The results of operations of HHI will be reported as discontinued operations beginning in the fourth quarter of 2021. David Maura, CEO of Spectrum Brands, said, “I am exceedingly proud of the fact that our Hardware & Home Improvement business nearly doubled its EBITDA under Spectrum Brands’ ownership.

I am pleased to know that HHI has found a new home with a great partner, and I am confident that ASSA ABLOY will take it to its highest potential, bringing great value and innovation to consumers for generations to come.

We believe this transaction demonstrates the tremendous value of Spectrum Brands as an owner and steward of our businesses and places the Company in a strong position for the future by allowing us to further reduce our leverage levels, and enhance our capital allocation strategy.

Our remaining business will be more focused, allowing us to prioritize innovation to accelerate organic growth and pursue synergistic acquisitions to further drive value creation in Global Pet Care and Home & Garden, while continuing to look for strategic and organic ways to enhance the value of Home and Personal Care.

After the closing, we will become a more pure play consumer staples company with higher growth rates and strong margins.”

The company added: “Spectrum Brands will be a simplified business consisting of three focused business units with leading market share, strong growth opportunities and consistent performance.

The pro forma business generated $3.0B in net sales and $386 million in Adjusted EBITDA representing a 13.0% margin for the LTM period ended July 4, 2021.

Spectrum Brands will report its fourth quarter 2021 results in mid-November and expects to provide Fiscal 2022 Earnings Framework at that time.”

ASSA ABLOY AB is a Swedish company that provides door opening products, solutions, and services for the institutional, commercial, and residential markets in Europe, the Middle East, Africa, North and South America, Asia, and Oceania.  In addition, the company offers entrance automation products, services, and components, such as automatic swing, sliding, and revolving doors; industrial doors; garage doors; high-performance doors; docking solutions; hangar doors; gate automation products; components for overhead sectional doors and sensors; and high security fencings and gates. The company provides its products primarily under the ASSA ABLOY, Yale, and HID brands.

Spectrum’s Hardware & Home Improvement segment offers hardware products under the National Hardware and FANAL brands; locksets and door hardware under the Kwikset, Weiser, Baldwin, EZSET, and Tell Manufacturing brands; and plumbing products under the Pfister brand. Its Home and Personal Care segment provides home appliances under the Black & Decker, Russell Hobbs, George Foreman, Toastmaster, Juiceman, Farberware, and Breadman brands; and personal care products under the Remington and LumaBella brands.

The company’s Global Pet Care segment provides rawhide chewing, dog and cat clean-up and food, training, health and grooming, small animal food and care, and rawhide-free products under the 8IN1 (8-in-1), Dingo, Nature’s Miracle, Wild Harvest, Littermaid, Jungle, Excel, FURminator, IAMS, Eukanuba, Healthy-Hide, DreamBone, SmartBones, ProSense, Perfect Coat, eCOTRITION, Birdola, and Digest-eeze brands.

ASAZY is down 38 cents to $15.53 per share while SPB is up $15 to $94.

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U.S. opposition leads to cancelation of merger

Aon plc, Willis Towers Watson mutually agree to terminate combination pact

Aon plc (AON) and Willis Towers Watson (WLTW) announced that the firms have agreed to terminate their business combination agreement and end litigation with the U.S. Department of Justice.

The proposed combination was first announced on March 9, 2020.

“Despite regulatory momentum around the world, including the recent approval of our combination by the European Commission, we reached an impasse with the U.S. Department of Justice,” said Aon CEO Greg Case.

“The DOJ position overlooks that our complementary businesses operate across broad, competitive areas of the economy. We are confident that the combination would have accelerated our shared ability to innovate on behalf of clients, but the inability to secure an expedited resolution of the litigation brought us to this point.”

In connection with the termination of the business combination agreement, Aon will pay the $1B termination fee to Willis Towers Watson, Willis Towers Watson’s proposed scheme of arrangement has now lapsed, and both organizations will move forward independently.

Aon CEO Greg Case gives up on the merger, pays $1B breakup fee

Both firms will provide further financial updates and outlooks on their respective Q2 2021 earnings calls, which take place on July 30 for Aon and August 3 for Willis Towers Watson.

Aon plc, a professional services firm, provides advice and solutions to clients focused on risk, retirement, and health worldwide. AON is based in Ireland.

Willis Towers Watson Public Limited Company operates as an advisory, broking, and solutions company worldwide. Willis is headquartered in London.

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Veoneer sold for $3.8B

Magna to acquire Veoneer for $31.25 per share in cash

Magna (MGA) and Veoneer (VNE) announced that they have entered into a definitive merger agreement under which Magna will acquire Veoneer.

The Swedish auto parts maker sold for $3.8B

Pursuant to the agreement, Magna will acquire all of the issued and outstanding shares of Veoneer for $31.25 per share in cash, representing a total value of $3.8B, and an enterprise value of $3.3B, inclusive of Veoneer’s cash, net of debt and other debt-like items as of March 31.

Magna expects to operate Veoneer’s Arriver sensor perception and drive policy software platform as an independent business unit, consistent with Veoneer’s current practice.

In addition, Magna will acquire Veoneer’s global position in restraint control systems.

Following the closing of the transaction, Veoneer will be combined with Magna’s existing ADAS business and integrated into Magna’s electronics operating unit.

The transaction has been unanimously approved by the Veoneer and Magna boards of directors, and Veoneer’s board of directors unanimously recommends that Veoneer stockholders approve the proposed merger and merger agreement.

In addition, Veoneer stockholders AMF, Cevian, AP4 and Alecta, which collectively represent approximately 40% of Veoneer’s outstanding shares of common stock, have either entered into support agreements with Magna or provided indications of support, pursuant to which they have agreed, among other things and subject to certain conditions, to vote their shares of Veoneer common stock in favor of the transaction.

A special meeting of Veoneer’s stockholders will be convened in connection with the transaction as soon as practicable after the mailing to Veoneer’s stockholders of the proxy statement in connection with the merger.

Magna is rumored to be making the Apple Car

The transaction is expected to close near the end of 2021, subject to the approval of Veoneer’s stockholders, certain regulatory approvals and other customary closing conditions. The transaction is not subject to any financing conditions.

Veoneer, Inc. engages in the design, development, manufacture, and sale of automotive safety electronics primarily in North America, Europe, and Asia. It offers automotive radars, mono-and stereo-vision cameras, night driving assist systems, advanced driver assist systems (ADAS), electronic control units, airbag control units, crash sensors, seat belt pre-tensioner electronic controllers, and ADAS software for highly automated driving (HAD) and autonomous driving (AD). Veoneer, Inc. is headquartered in Stockholm, Sweden.

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ECB sets a two percent target for inflation

ECB keeps key interest rates unchanged, revises forward guidance on rates

The ECB said: “In its recent strategy review, the Governing Council agreed a symmetric inflation target of two per cent over the medium term.

The key ECB interest rates have been close to their lower bound for some time and the medium-term outlook for inflation is still well below the Governing Council’s target.

In these conditions, the Governing Council today revised its forward guidance on interest rates. It did so to underline its commitment to maintain a persistently accommodative monetary policy stance to meet its inflation target.

In support of its symmetric two per cent inflation target and in line with its monetary policy strategy, the Governing Council expects the key ECB interest rates to remain at their present or lower levels until it sees inflation reaching two per cent well ahead of the end of its projection horizon and durably for the rest of the projection horizon, and it judges that realized progress in underlying inflation is sufficiently advanced to be consistent with inflation stabilizing at two per cent over the medium term.

This may also imply a transitory period in which inflation is moderately above target.

Having confirmed its June assessment of financing conditions and the inflation outlook, the Governing Council continues to expect purchases under the pandemic emergency purchase program – PEPP – over the current quarter to be conducted at a significantly higher pace than during the first months of the year…

The interest rate on the main refinancing operations and the interest rates on the marginal lending facility and the deposit facility will remain unchanged at 0.00%, 0.25% and -0.50% respectively.”

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Johnson & Johnson files for FDA approval of it’s Covid-19 Vaccine

 J&J submits FDA application for emergency use authorization for COVID-19 vaccine

Johnson & Johnson (JNJ) announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration requesting Emergency Use Authorization for its investigational single-dose Janssen COVID-19 vaccine candidate.

https://stockwinners.com/blog
JNJ files for approval of Covid-19 vaccine

The company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints.

The Company expects to have product available to ship immediately following authorization. “Today’s submission for Emergency Use Authorization of our investigational single-shot COVID-19 vaccine is a pivotal step toward reducing the burden of disease for people globally and putting an end to the pandemic,” said Paul Stoffels, M.D., Vice Chairman of the Executive Committee and Chief Scientific Officer at Johnson & Johnson.

“Upon authorization of our investigational COVID-19 vaccine for emergency use, we are ready to begin shipping. With our submission to the FDA and our ongoing reviews with other health authorities around the world, we are working with great urgency to make our investigational vaccine available to the public as quickly as possible.”

Johnson & Johnson intends to distribute vaccine to the U.S. government immediately following authorization, and expects to supply 100 million doses to the U.S. in the first half of 2021.

JNJ last traded at $161.99.

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$5B Merger in LNG Space

New Fortress Energy to buy Hygo ,Golar LNG Partners combined in $5B deal

New Fortress Energy (NFE) announced that it has entered into definitive agreements to acquire Hygo Energy Transition a 50-50 joint venture between Golar LNG Limited (GLNG) and Stonepeak Infrastructure Fund II Cayman.

New Fortress goes shopping

“With a strong presence in Brazil and a world-class LNG shipping business, Hygo and GMLP are excellent additions to our efforts to accelerate the world’s energy transition,” said Wes Edens, Chairman and CEO of NFE.

“The addition of Hygo will quickly expand our footprint in South America with three gas-to-power projects in Brazil’s large and fast-growing market. With GMLP, we gain LNG ships and world-class operators that are an ideal fit to support our existing terminals and robust pipeline.”

“We are impressed with what Wes Edens and the NFE team have created and their commitment to changing the energy industry,” said Golar LNG Chairman Tor Olav Troim.

“They share our vision to provide cheaper and cleaner energy to a growing population. The consolidation of two of the entrepreneurial LNG downstream players gives the company improved access to capital and creates a unique world-leading energy transition company which Golar shareholders will benefit from being a part of going forward.”

With the acquisition of Hygo, NFE will acquire an operating floating storage and regasification unit terminal and a 50% interest in a 1500MW power plant in Sergipe, Brazil as well as two other FSRU terminals with 1200MW of power in advanced stages in Brazil.

Hygo’s fleet consists of a newbuild FSRU and two operating LNG carriers.

NFE will also acquire a leading owner of FSRUs and LNG carriers as well as a pioneer in floating liquefaction technologies with the GMLP transaction.

The addition of GMLP’s fleet of six FSRUs, four LNG carriers and a 50% interest in Trains 1 and 2 of the Hilli, a floating liquefaction vessel, is expected to support both NFE’s , NFE will acquire all of the outstanding shares of Hygo for 31.4M shares of NFE Class A common stock and $580M in cash.

The transaction is valued at a $3.1B enterprise value and a $2.18B equity value.

Pursuant to the transaction, GLNG will receive 18.6 million shares of NFE Class A common stock and $50 million in cash and Stonepeak will receive 12.7 million shares of NFE Class A common stock and $530 million in cash.

Hygo’s Board of Directors, together with GLNG and Stonepeak, the shareholders of Hygo, have unanimously approved the proposed transaction with NFE.

The closing of the transaction is subject to the receipt of certain regulatory approvals and third party consents and other customary closing conditions, and is expected to occur in the first half of 2021.

Under NFE’s agreement with GMLP , NFE has agreed to acquire all of the outstanding common units of GMLP for $3.55 per common unit in cash.

NFE has also agreed to acquire GMLP’s general partner for equivalent consideration based on the general partner’s economic interest in GMLP.

The preferred units of GMLP will remain outstanding. The transaction is valued at a $1.9B enterprise value and $251 million common equity value.

GMLP’s Board of Directors, acting upon the recommendation of a special committee of independent directors of GMLP, unanimously approved the proposed transaction with NFE.

The closing of the transaction is subject to the approval by the holders of a majority of GMLP’s outstanding common units, the receipt of certain regulatory approvals and third party consents and other customary closing conditions, and is expected to occur in the first half of 2021.

GLNG has entered into a support agreement with NFE committing to vote its approximately 30.8% interest in GMLP’s common units in favor of the transaction.

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Virtusa sold for $2 billion

Virtusa to be acquired by BPEA for $51.35 per share in cash deal valued at $2B

Baring Private Equity Asia, or BPEA, and Virtusa (VRTU) announced the companies have entered into a definitive merger agreement under which funds affiliated with BPEA will acquire all outstanding shares of common stock of Virtusa for $51.35 per share in an all-cash transaction valued at approximately $2B.

Virtusa Corporation provides digital engineering and information technology (IT) outsourcing services primarily in North America, Europe, and Asia.

Virtusa sold for $2B

The companies said in a release, “The price per share to be paid in the transaction, which was unanimously approved by the Virtusa Board of Directors, represents a premium of approximately 27 percent to the closing price of Virtusa common stock on September 9, 2020, the last trading day prior to the transaction announcement, and premiums of approximately 29 percent and 46 percent to Virtusa’s volume-weighted average prices, or VWAP, for the last 30 and 60 trading days, respectively.

In addition, the price paid implies a valuation of 16.2x Firm Value / Last Twelve Months EBITDA as of June 30, 2020. On July 20, 2020, the Virtusa Board of Directors received an unsolicited proposal from an interested party to acquire Virtusa.

BPEA buys Virtusa for $2 billion

Following receipt of the offer, consistent with the Board’s fiduciary duties to maximize shareholder value, the Board authorized the Company and its financial advisors to engage with other potential strategic buyers and financial sponsors regarding a potential acquisition of Virtusa.

As part of this process, the Company signed non-disclosure agreements with five parties and engaged with two others.

After an independent review of the alternatives available, including the value creation opportunity through continued execution of the Company’s strategic plan, the Virtusa Board unanimously determined that the all-cash premium transaction with BPEA for $51.35 per share in cash maximizes value for Virtusa’s shareholders.

The transaction, which is expected to close in the first half of 2021, is subject to the approval of Virtusa’s shareholders, customary regulatory requirements, including approval from The Committee on Foreign Investment in the United States, or CFIUS, and customary closing conditions.

The transaction is not subject to a financing condition.

The Orogen Group, which holds 108,000 shares of Virtusa Convertible Preferred Stock and whose CEO is Vikram Pandit, an independent member of the Board, has entered into a voting agreement under which it has agreed to vote all of Orogen’s Convertible Preferred Stock in favor of the transaction.

Orogen Group is a major shareholder of Virtusa

Orogen’s shares of preferred stock are convertible into 3,000,000 shares of Virtusa common stock and represent approximately 10 percent of the voting power in the Company.

The directors and executive officers of Virtusa have also entered into this voting agreement, and hold an additional approximate 5.7% of the voting power of the Company.”

VRTU closed at $40.50, last traded at $50.45.

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Direct Energy sold for $3.63 billion

NRG Energy to acquire Direct Energy from Centrica for $3.63B in cash

NRG Energy (NRG) announced it has entered into a definitive agreement with UK’s Centrica (CPYYY) under which NRG will acquire Direct Energy, a North American subsidiary of Centrica PLC for $3.63B in an all-cash transaction.

NRG Energy said in a release, “The transaction builds on NRG’s status as a growing, customer-driven integrated energy provider, adding more than three million retail customers across 50 states and Canada.

NRG goes shopping

The transaction on closing is expected to generate approximately $740M in annual run-rate Adjusted EBITDA, while enhancing free cash flow strength and stability and providing earnings diversification.

With operations in all 50 U.S. states and 6 Canadian provinces, Direct Energy is one of North America’s leading retail providers of electricity, natural gas, and home and business energy-related products and services.

Centrica sells Direct Energy

For NRG, the acquisition builds on and complements its integrated model, enabling better matching of power generation with customer demand.

It also broadens NRG’s presence into states and locales where it does not currently operate, supporting NRG’s objective to diversify its business.

The combination will deliver greater efficiencies and enable continued investment in NRG’s award-winning customer service, operational best practices and reliability.

Direct Energy fetches $3.63B

With NRG’s decades of participation in electricity markets throughout the U.S., NRG has broad insights into energy market dynamics and trends to inform innovative solutions and products for the combined company’s customers.

NRG will acquire Direct Energy for $3.63B in cash, subject to a working capital adjustment. Closing for the transaction is targeted by year end 2020.”

NRG Energy, Inc. operates as an energy company in the United States. It operates through Generation and Retail segments. The company is involved in the producing, selling, and delivering electricity and related products and services to 3.7 million residential, industrial, and commercial consumers. It generates electricity using natural gas, coal, oil, solar, nuclear, and battery storage. 

Direct Energy LP is a North American retailer of energy and energy services. The company was founded in Toronto in 1986 and now has more than four million customers in Canada and the United States. 

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IMF warns of global slowdown

International Monetary Fund cuts global growth forecast

IMF cuts global growth forecast and warns that the rebound in global financial markets “appears disconnected from shifts in underlying economic prospects”.

The fund now expects global GDP to shrink -4.9% this year, from -3.0% expected in April.

For next year, the IMF sees a rebound of 5.4%, also lower than the 5.8% projected two months ago with downward revisions reflecting the deep scars from a larger than expected supply shock during lockdowns as well as a continued hit to demand from social distancing and other virus measures.

Orange color designates economic downgrades

The IMF warned that for nations struggling to control the spread of the virus a longer lockdown will also take a toll on growth.

“With the relentless spread of the pandemic, prospects of long lasting negative consequences for livelihoods, job security and inequality have grown more daunting”, according to the fund’s update to the World Economic Outlook.

Advanced economies are expected to lead the downdraft with a -8.0% rate, versus -6.1% in the prior forecast.

The outlook on the U.S. was downgraded to -8.0% from -5.9%.

The projection on the Euro Area was knocked down to -10.2% from -7.5%. The UK is also seen posting a -10.2% contraction versus -6.5% previously. Japan was revised to -5.8% from -5.2%.

Emerging market and developing economies are seen falling -3.0% versus -1.0% in the April forecast. China is expected to expand 1.0%, though down from the prior 1.2%.

The largest revision was seen with India where the prior 1.9% growth rate was revised to a -4.5% contraction. World trade volume is projected tumbling at a -11.9% pace this year, a downgrade from -11.0% previously, though is expected to bounce back to an 8.0% growth rate in 2021.

Consumer prices in Advanced economies is seen slowing to 0.3% versus the prior estimate of 0.5%, and is down from a 1.4% pace in 2019.

Several central bank officials have also tried to reign in optimism about the recovery as markets seem to run away with the recovery story.

India’s economy is expected to hit hard with Covid-19

Massive monetary and fiscal support may help to kick-start a rebound, but as ECB chief economist Lane warned today, it will take a long time to reach pre-crisis levels.

The Bank o Japan’s summary of opinion warned that a prolonged negative impact of virus developments on the economic outlook looks unavoidable. And China’s Beige Book expects a contraction for China’s economy this year. 

New York Governor Andrew Cuomo, along with Governor Phil Murphy of New Jersey and Governor Ned Lamont of Connecticut, announced a joint travel advisory.

All individuals traveling from states with significant community spread of COVID-19 into any of the three states must quarantine for 14 days, the governors announced.

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Rig Counts Decline!

Baker Hughes reports U.S. rig count down 5 to 279 rigs

Baker Hughes (BKR) reports that the U.S. rig count is down 5 rigs from last week to 279 with oil rigs down 7 to 199, gas rigs up 2 to 78, and miscellaneous rigs unchanged at 2.

The U.S. Rig Count is down 690 rigs from last year’s count of 969, with oil rigs down 589, gas rigs down 103, and miscellaneous rigs up 2 to 2.

Rig counts decline

The U.S. Offshore Rig Count is unchanged at 13 and down 11 year-over-year.

The international offshore rig count for April 2018 was 194. Stockwinners

The Canada Rig Count is unchanged from last week at 21, with oil rigs unchanged at 7 and gas rigs unchanged at 14.

The Canada Rig Count is down 86 rigs from last year’s count of 107, with oil rigs down 62 and gas rigs down 24.

WTI crude is down 14 cents to $36.20 per barrel. Brent is up 28 cents to $38.88 per barrel.

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Norwegian Cruise Line shores up its balance sheet, raises $2B

NCL Corporation announces $400M investment by L Catterton

Norwegian Cruise proposes $650M note sale

Norwegian Cruise Line Holdings (NCLH) announced a private placement of up to $400 million in aggregate principal amount of exchangeable senior notes due 2026 to an affiliate of L Catterton.

Norwegian raises $2 billion to shore up its balance sheet

The Private Exchangeable Notes will be general senior unsecured obligations of NCLC, guaranteed by NCLH, and will be exchangeable at the holder’s option at any time prior to the close of business on the business day immediately preceding the maturity date into Series A Preference Shares of NCLC, which shall be automatically exchangeable into a number of ordinary shares of NCLH.

Material Terms: The Private Exchangeable Notes will accrue payment-in-kind interest at a rate of 7.0% per annum for the first year post-issuance, 4.5% per annum payment-in-kind interest plus 3.0% per annum cash interest for the following four years post issuance and 7.5% in cash for the final year prior to maturity; L Catterton will be entitled to nominate one member to the Company’s board of directors so long as a minimum ownership threshold is met, as well as one observer to the Company’s board of directors; The closing of the Private Exchangeable Notes is expected to occur upon the satisfaction of certain customary closing conditions, including a condition that the Company raises at least $1.0 billion in proceeds in the aggregate from other offerings; L Catterton will have certain registration rights in respect of the ordinary shares underlying the Private Exchangeable Notes and will be subject to certain customary transfer, voting and standstill restrictions, including a one-year lock-up agreement.

Share Offerings

Norwegian Cruise Line Holdings announced an underwritten public offering of $350 million of ordinary shares of the company.

The company intends to grant the underwriters an option to purchase up to $52.5 million of additional ordinary shares.

The company expects to use the net proceeds from the Offering for general corporate purposes. Goldman Sachs & Co. LLC, Barclays Capital Inc., Citigroup Global Markets Inc., J.P. Morgan Securities LLC and Mizuho Securities USA LLC are acting as joint book-running managers for the Offering.

Goldman Sachs

Goldman Sachs analyst Stephen Grambling lowered the firm’s price target on Norwegian Cruise Line to $15 from $34 as he updated his estimates to reflect canceled itineraries through July, a sluggish recovery in 2020-2021 and capital markets activity over the past few weeks, but not the cruise operator’s just announced and pending transactions.

After the company announced plans to raise $600M of senior secured debt, $650M of exchangeable notes, and $350M in equity, and placed $400mn of exchangeable notes with Catterton Partners, Grambling said the added $2B in liquidity provides the company with runway of over 14 months at company estimated cash burn rates. He keeps a Neutral rating on Norwegian shares.

NCLH is down $2.80 to $11.65. We believe shares have found support at these levels.

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Central Banks flood markets with cash

  • Fed lowers federal funds target rate to 0%-0.25% on coronavirus outbreak
  • Fed, other central banks announce action to enhance U.S. dollar liquidity
  • Fed to up Treasury securities holdings by at least $500B, MBS by at least $200B
  • Expect added volatility in financial markets
Corona slowdown leads to drastic decisions, Stockwinners

The Federal Reserve said in a Sunday night statement, “The coronavirus outbreak has harmed communities and disrupted economic activity in many countries, including the United States. Global financial conditions have also been significantly affected.

Available economic data show that the U.S. economy came into this challenging period on a strong footing. Information received since the Federal Open Market Committee met in January indicates that the labor market remained strong through February and economic activity rose at a moderate rate. Job gains have been solid, on average, in recent months, and the unemployment rate has remained low. Although household spending rose at a moderate pace, business fixed investment and exports remained weak. More recently, the energy sector has come under stress.

Global inflation from 2007-2017, Stockwinners

On a 12-month basis, overall inflation and inflation for items other than food and energy are running below 2 percent.

Market-based measures of inflation compensation have declined; survey-based measures of longer-term inflation expectations are little changed. Consistent with its statutory mandate, the Committee seeks to foster maximum employment and price stability. The effects of the coronavirus will weigh on economic activity in the near term and pose risks to the economic outlook.

In light of these developments, the Committee decided to lower the target range for the federal funds rate to 0 to 1/4 percent.

The Committee expects to maintain this target range until it is confident that the economy has weathered recent events and is on track to achieve its maximum employment and price stability goals. This action will help support economic activity, strong labor market conditions, and inflation returning to the Committee’s symmetric 2 percent objective.”


The Federal Reserve said “To support the smooth functioning of markets for Treasury securities and agency mortgage-backed securities that are central to the flow of credit to households and businesses, over coming months the Committee will increase its holdings of Treasury securities by at least $500 billion and its holdings of agency mortgage-backed securities by at least $200 billion. The Committee will also reinvest all principal payments from the Federal Reserve’s holdings of agency debt and agency mortgage-backed securities in agency mortgage-backed securities.

QE 4 initiated by the Feds on a Sunday night, Stockwinners

In addition, the Open Market Desk has recently expanded its overnight and term repurchase agreement operations. The Committee will continue to closely monitor market conditions and is prepared to adjust its plans as appropriate,” the central bank announced.


In an extraordinary move, the Bank of Canada, the Bank of England, the Bank of Japan, the European Central Bank, the Federal Reserve, and the Swiss National Bank announced a coordinated action to enhance the provision of liquidity via the standing U.S. dollar liquidity swap line arrangements.

The Federal Reserve stated: “These central banks have agreed to lower the pricing on the standing U.S. dollar liquidity swap arrangements by 25 basis points, so that the new rate will be the U.S. dollar overnight index swap rate plus 25 basis points.

To increase the swap lines’ effectiveness in providing term liquidity, the foreign central banks with regular U.S. dollar liquidity operations have also agreed to begin offering U.S. dollars weekly in each jurisdiction with an 84-day maturity, in addition to the 1-week maturity operations currently offered. These changes will take effect with the next scheduled operations during the week of March 16.

The new pricing and maturity offerings will remain in place as long as appropriate to support the smooth functioning of U.S. dollar funding markets. The swap lines are available standing facilities and serve as an important liquidity backstop to ease strains in global funding markets, thereby helping to mitigate the effects of such strains on the supply of credit to households and businesses, both domestically and abroad.”

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Alkermes submits NDA for its schizophrenia drug

Alkermes says FDA accepts ALKS 3831 NDA for review, assigns Nov. 15 PDUFA date

Alkermes (ALKS) announced that the U.S. Food and Drug Administration has accepted for review the company’s New Drug Application, or NDA, seeking approval of ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder.

Alkermes announces FDA Refusal to File letter received for ALKS 5461. Stockwinners
Alkermes announces filing on NDA for ALKS3831, Stockwinners

ALKS 3831 is an investigational, novel, once-daily, oral atypical antipsychotic drug candidate designed to provide the efficacy of olanzapine while mitigating olanzapine-associated weight gain.

The NDA has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of Nov. 15, 2020.

“The acceptance of the NDA for ALKS 3831 marks an important milestone toward our goal of offering a new treatment option to people living with schizophrenia or bipolar I disorder. The ALKS 3831 development program builds on Alkermes’ commitment to developing new therapeutic options that seek to address unmet needs of patients in large therapeutic areas. We believe ALKS 3831 has the potential to be a meaningful new offering for patients with these serious and complex mental health disorders, and we look forward to engaging with the FDA throughout the NDA review process,” said Craig Hopkinson, M.D., Chief Medical Officer at Alkermes.

Alkermes plc researches, develops, and commercializes pharmaceutical products to address unmet medical needs of patients in various therapeutic areas in the United States, Ireland, and internationally.

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Watch Jazz Pharmaceuticals!

Jazz Pharmaceuticals receives EU Marketing Authorization for Sunosi

Jazz Pharmaceuticals (JAZZ) announced that the European Commission approved Sunosi to improve wakefulness and reduce excessive daytime sleepiness in adults with narcolepsy or obstructive sleep apnea whose EDS has not been satisfactorily treated by primary OSA therapy, such as continuous positive airway pressure.

Jazz should be in play, Stockwinners

Sunosi is the first dual-acting dopamine and norepinephrine reuptake inhibitor approved to treat EDS in adults living with narcolepsy or OSA and the only licensed therapy in the European Union for the treatment of EDS in adults living with OSA.

Once-daily Sunosi is approved with doses of 75 mg and 150 mg for people with narcolepsy and doses of 37.5 mg, 75 mg and 150 mg for patients with OSA.

Sunosi is approved in Europe, Stockwinners

At Week 12 of the Phase 3 clinical trial, 150 mg of solriamfetol for narcolepsy patients and both 75 mg and 150 mg doses for OSA patients demonstrated improvements in wakefulness compared to placebo as assessed via the maintenance of wakefulness test from approximately one hour post-dose through approximately nine hours post-dose.

The European Commission approval extends to all European Union Member States, as well as Iceland, Norway and Liechtenstein.

The Marketing Authorization Application for Sunosi is based on data from four randomized placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness clinical trial program.

Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.

The Marketing Authorisation Application (MAA) for Sunosi is based on data from four randomised placebo-controlled studies included in the Treatment of Obstructive sleep apnea and Narcolepsy Excessive Sleepiness (TONES) clinical trial program. Data from the studies in the TONES program demonstrated the superiority of solriamfetol relative to placebo.

JAZZ closed at $151.05.

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