CureVac (CVAC) and EU in advanced talks for 225 million Covid-19 vaccine doses

• CureVac has said its Covid-19 vaccine could be ready for the public by mid-2021

Shares of CureVac NV soared Thursday after the German biotech firm said it was in advanced talks for the supply of at least 225 million doses of a potential Covid-19 vaccine to EU member states.

CureVac said talks with the EC, the European Union’s executive arm, include an option to supply an additional 180 million doses, once the mRNA-based vaccine has proven to be safe and effective against Covid-19, bringing the total to up to 405 million doses.

The EC is also in talks with Johnson & Johnson (JNJ) and France’s Sanofi (SNY) for their vaccines under development. It also reached an agreement last week with AstraZeneca (AZN) to buy at least 300 million doses of its potential Covid-19 vaccine which it is developing with Oxford University.

CureVac (CVAC) is specializing in the messenger RNA technology that is the basis of many of the leading Covid-19 vaccine programs, including Moderna Inc. (MRNA) and BioNTech S.E. (BNTX).

“In the current pandemic, we are very pleased to further strengthen the European Commission’s endeavor to provide rapid access to a safe and effective vaccine against the Covid-19 virus across Europe and beyond,” Franz-Werner Haas, chief executive of CureVac said.

“Assuming positive results from our ongoing clinical trials and approval from the regulatory authorities, we are fully committed to ensure broad access to our vaccine,” he added.

Backed by Microsoft founder and billionaire Bill Gates, CureVac listed on the Nasdaq Stock Market on Aug. 14, raising $213 million.

In July, GlaxoSmithKline PLC (GSK) said it was taking a stake in CureVac, the latest move by a major drugmaker to boost capabilities to fight pandemics. FTSE 100-listed Glaxo said CureVac’s mRNA technology would complement its own capabilities as it inked a deal worth up to £866 million ($1.09 billion).

=GlaxoSmithKline (GSK) and Pfizer (PFE) to combine their consumer health businesses into a new joint venture

GlaxoSmithKline reached agreement with Pfizer (PFE) to combine their consumer health businesses into a new joint venture 

• Co reached agreement with Pfizer Inc to combine their consumer health businesses into a new world-leading Joint Venture, with combined sales of approximately 9.8 billion ($12.7 billion). 
• GSK will have a majority controlling equity interest of 68% and Pfizer will have an equity interest of 32% in the Joint Venture.
• The proposed transaction is expected to realize substantial cost synergies, with the Joint Venture expected to generate total annual cost savings of 0.5 billion by 2022 for expected total cash costs of 0.9 billion and non-cash charges of 0.3 billion. Planned divestments targeting around 1 billion of net proceeds are expected to cover the cash costs of the integration. Up to 25% of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities. Overall the Joint Venture will target an Adjusted operating margin percentage in the 'mid-to-high 20's' by 2022.
• The proposed transaction is transformational to the scale of GSK's Consumer Healthcare business. Within 3 years of the closing of the transaction, GSK intends to separate the Joint Venture via a demerger of its equity interest and a listing of GSK Consumer Healthcare on the UK equity market. Over this period, GSK will substantially complete the integration and expects to make continued progress in strengthening its Pharmaceuticals business and R&D pipeline.
•  The proposed transaction is subject to approval by GSK shareholders and conditional upon the receipt of certain anti-trust authority approvals. Subject to these approvals, the transaction is expected to close in the second half of 2019.

=Tesaro (TSRO) to be acquired by GSK (GSK) for $75/share

Tesaro to be acquired by GSK (GSK) for $75/share in cash, or approximately $5.1 bln

• GSK expects the acquisition of TESARO and associated R&D and commercial investments will impact Adjusted EPS for the first two years by mid to high single digit percentages, reducing thereafter with the acquisition expected to start to be accretive to Adjusted EPS by 2022. GSK's guidance for full-year 2018 Adjusted EPS growth remains unchanged at 8 to 10% at CER. GSK continues to expect to deliver on its previously published Group Outlooks to 2020, but following the acquisition of TESARO now expects Adjusted EPS growth at CER for the period 2016-2020 to be at the bottom end of the mid to high single digit percentage CAGR range.
• GSK confirms no change to its current dividend policy and continues to expect to pay 80p in dividends for 2018.
• The transaction is expected to complete in the first quarter of 2019, subject to satisfaction of customary closing conditions, including the tender by TESARO stockholders of at least one share more than 50% of the issued and outstanding shares of TESARO and required regulatory approvals, including clearance by the US Federal Trade Commission.

=GlaxoSmithKline (GSK) reported earnings on Wed 25 Apr 2018 (b/o)

GlaxoSmithKline beats by GBP 0.01, misses on revs; reaffirms FY18 EPS assuming no generic Advair introduction 

• Reports Q1 (Mar) earnings of GBP0.25 per share, GBP0.01 better thanthe Capital IQ Consensus of GBP0.24; revenues fell 2.2% year/year to GBP7.22 bln vs the GBP7.32 bln Capital IQ Consensus, with CER growth delivered by all three businesses.
• The Group expects to make continued progress in 2018, although the expectation for Adjusted EPS growth is impacted by a number of factors including, in particular, uncertainties relating to the timing and extent of potential generic competition to Advair in the US. In the event that no substitutable generic competitor to Advair is introduced to the US market in 2018, the Group continues to expect 2018 Adjusted EPS growth of 4 to 7% at CER. In the first quarter, the Group has made continued progress, with encouraging performances from new launches, Shingrix, Trelegy and Juluca and other new products, as well as agreeing the buyout of Novartis' shareholding in the Consumer Healthcare Joint Venture, subject to shareholder approval. However, the Group has also seen increased pricing and competitive pressures in the US inhaled respiratory market in the first quarter, and GSK now expects a decline in 2018 US Advair sales of around 30% at CER. In the event of a mid-year introduction of a substitutable generic competitor to Advair in the US, the Group expects full year 2018 US Advair sales of around 750 million at CER (US$1.30/1), with Adjusted EPS flat to down 3% at CER.

=GlaxoSmithKline (GSK) reported earnings on Wed 26 July 2017 (b/o)

GlaxoSmithKline beats by GBP 0.01, reports revs in-line; issues guidance:

• Reports Q2 (Jun) earnings of GBP0.27 per share, excluding non-recurring items, GBP0.01 better than the Capital IQ Consensus of GBP0.26; revenues rose 12.1% year/year to GBP7.32 bln vs the GBP7.27 bln Capital IQ Consensus. 
• The utilisation of the Priority Review Voucher, together with other accelerated launch costs for the HIV two drug regimen, has impacted GSK's previous expectations for growth in Adjusted EPS by around two percentage points. With no Advair generic expected in the US in 2017, GSK now expects 2017 Adjusted EPS growth to be 3% to 5% CER. If exchange rates were to hold at the closing rates on 30 June 2017 ($1.30/1, 1.14/1 and Yen 146/1) for the rest of 2017, the estimated positive impact on full-year 2017 Sterling turnover growth would be around 5% and if exchange losses were recognised at the same level as in 2016, the estimated positive impact on 2017 Sterling Adjusted EPS growth would be around 8%.
• GSK expects sales to grow at CER at a low-to-mid single digits percentage CAGR and Adjusted EPS to grow at a mid-to-high single digits percentage CAGR for the period 2016-2020. These outlooks are based on 2015 exchange rates and anticipate that at least one version of generic Advair will be launched in the US before 2020. The outlook includes the divestments announced today and those executed since 2015 (0.9 billion in annual sales).
• The Board intends to maintain the dividend for 2018 at the current level of 80p per share, subject to any material change in the external environment or performance expectations. Over time, as free cash flow strengthens, it intends to build free cash flow cover of the annual dividend to a target range of 1.25-1.50x, before returning the dividend to growth.