Biotech week ahead, Jan. 25

 Biopharma stocks advanced yet again in the week ended Jan. 22, with the change of guard at the White House generating broader market strength.

Eli Lilly And Co LLY 2.04% was the standout biopharma stock of the week, as it set fresh 52-week highs in all four sessions of the truncated week, the catalysts being an oncology licensing deal with Merus NV MRUS 0.07%, an analyst upgrade and a positive readout for its COVID-19 antibody treatment candidate.

News flow on licensing deals and follow-on offerings abounded.

The Food and Drug Administration approved two key drugs during the week — Merck & Co., Inc.'s MRK 0.25% heart failure drug and a long-acting, injectable combo treatment option for HIV from ViiV Healthcare, a venture established by GlaxoSmithKline plc GSK 1.56% and Pfizer Inc. PFE 0.16%.

Aurinia Pharmaceuticals Inc's AUPH 2.17% voclosporin in combination with a background immunosuppressive therapy regimen was also approved by the agency to treat adult patients with active lupus nephritis.

Here are the key catalysts for the unfolding week:

Conferences:

The International Association for the study of Lung Cancer, or IASLC, World Conference on Lung Cancer (virtual event): Jan. 28-31

PDUFA Dates:

The FDA is scheduled to rule on Amgen, Inc.'s AMGN 0.58% sBLA for Nplate, a protein that raises and sustains platelet counts, as a treatment option for hematopoietic subsyndrome of acute radiation syndrome. The decision is due Thursday, Jan. 28.

Related Link: The Gilead, Galapagos Pipeline Opportunities That Are Turning Morgan Stanley Bullish

Regulatory Filings:

Axsome Therapeutics Inc AXSM 1.65% expects to file this month a new drug application for its AXS-05 treatment of mild depressive disorder.

Clinical Readouts:

Rhythm Pharmaceuticals Inc RYTM 9.85% is scheduled to host a virtual event on Tuesday, Jan. 26, from 8 a.m. to 10 a.m. to provide an update on its ongoing exploratory Phase 2 study and genetic sequencing efforts. The company will present data for setmelanotide in individuals living with heterozygous obesity due to genetic variants in one of two alleles of the POMC, PCSK1 or LEPR gene, as well as SRC1 and SH2B1 deficiency obesities. It will also provide an update on data from its sequencing efforts, which now includes samples from about 37,500 people with severe obesity.

Zymeworks Inc ZYME 0.31% is due to present a clinical progress update for ZW49, which is being evaluated in a Phase 1 clinical trial as a treatment for patients with locally advanced or metastatic HER2-expressing cancers. The presentation is scheduled for Wednesday, Jan. 27, at 4:30 p.m.

January Readouts

Johnson & Johnson JNJ 1.09%: interim results of a Phase 3 clinical trial of its experimental COVID-19 vaccine, JNJ-78436735

GlaxoSmithKline plc GSK 1.56%/Vir Biotechnology Inc VIR 4.41%: initial results from the Phase 3 trial of COVID-19 antibody treatment candidate VIR-7831

IASLC World Conference on Lung Cancer Presentations

Amgen: Phase 2 data from the CodeBreaK 100 clinical study, evaluating investigational sotorasib in patients with KRAS G12C-mutated advanced non-small cell lung cancer, or NSCLC, (Friday, Jan. 2), and an oral presentation of updated Phase 1 data from AMG 757 in small cell lung cancer

Earnings:

Tuesday

Johnson & Johnson JNJ 1.09% (before the market open)
Varian Medical Systems, Inc. VAR 0.02% (after the close)

Wednesday

Abbott Laboratories ABT 0.15% (before the market open)
Edwards Lifesciences Corp EW 1.95%(after the close)
Hologic, Inc. HOLX 0.29% (after the close)
Taro Pharmaceutical Industries Ltd. TARO 0.63% (after the close)

Thursday

ABIOMED, Inc. ABMD 0.19% (before the market open)
ResMed Inc. RMD 0.56% (after the close)

Friday

Lilly (before the market open)

IPOs

Raritan, New Jersey-based Ortho Clinical Diagnostics Holdings plc has filed to offer 70 million shares in an initial public offering, expected to be priced between $20 and $23. The pure-play in vitro diagnostics company has applied for listing the shares on the Nasdaq under the ticker symbol OCDX.

https://www.benzinga.com/news/earnings/21/01/19285457/the-week-ahead-in-biotech-jan-24-30-j-j-lilly-to-kickstart-big-pharma-earnings-amgen-fda-decision-a

Biotech deal premiums still punchy

 Lofty asset prices mean that determined buyers will need to dig deep to seal deals in 2021. Still, an analysis of historic M&A premiums suggests that this might not be too surprising: average premiums remained close to 100% in 2020, after breaching that number in 2019, the latest EvaluatePharma data show. The last couple of years have been remarkable because even large takeovers have been struck at very keen terms – it tends to be the smaller transactions that attract triple-figure premiums, which explains why the average is so high in 2016, a quiet M&A year in which only a handful of small deals happened. In 2020 three R&D-stage and three commercial-stage drug developers were bought in triple-figure premium deals. Those struck by Gilead stand out among the most sizeable: the big US biotech paid $4.9bn for Forty Seven and $21bn for Immunomedics, at premiums of 110% and 111% respectively. And, while the data seem to suggest that commercial-stage developers see less fluctuation on this metric, it is notable that three of the biggest premiums paid over this period occurred in 2020. Perhaps buyers should be braced for more price inflation this year.

 Commercial stage: 33%

Note: Premiums calculated from average share price over 30 days before deal announcement. Only includes acquisitions of pure-play drug developers; medtech, diagnostics, digital health etc excluded. 

https://www.evaluate.com/vantage/articles/news/snippets/biotech-deal-premiums-still-punchy

Biopharma’s stock market winners and losers in 2020

 It is no secret that the pandemic has been kind to drug developers, in terms of financial performance at least, with cash flowing into the sector and, in many cases, share prices surging. Thus, those working on Covid-19 treatments feature widely in 2020’s biggest gainers table, from vaccine makers like Biontech to South Korea’s Shin Poong, whose work on a repurposed malaria drug caused its stock to surge. On the faller’s side, any year contains a number of blow-ups in this high-risk sector, though investors in Amarin and Galapagos will be particularly sore; a surprise patent loss and unexpected R&D setbacks respectively caused the pain. Even the traditionally staid big caps provided some big swings last year, with the valuations of Lilly and Abbvie ballooning by billions on the back of clinical successes. Glaxo’s decline is also notable; the stock has been battered by concerns about cash flow and dividends, compounded by a weak R&D strategy that took another knock this week. It is barely credible that Moderna’s market cap is over half of Glaxo’s, a stark statistic that speaks to stock market frothiness, but that should also make executives at the now not-so-big pharma shift uncomfortably.

Biggest share price gainers of 2020
Company	Share price gain	Market cap gain ($bn)	Market cap at Dec 2020 ($bn)
Big pharma
Lilly ($)	28%	35.3	161.5
Abbvie ($)	21%	58.2	189.2
Johnson & Johnson ($)	8%	30.4	414.3
Big drug makers (+$25bn)
Lonza (SFr)	61%	20.0	46.4
Merck KGaA (€)	33%	20.9	71.3
Regeneron ($)	29%	10.1	50.7
Mid-caps ($5-25bn)
Moderna ($)	434%	34.8	41.3
Biontech ($)	126%	12.0	19.6
Celltrion (KRW)	98%	22.7	42.4
Small caps ($250m-5bn)
Shin Poong (KRW)	1,613%	5.4	5.7
Cytodyn ($)	439%	2.8	3.2
Denali ($)	381%	8.4	10.0
Arising from the micro caps… (<$250m)
Novavax ($)	2,702%	7.6	7.7
Seres Therapeutics ($)	661%	2.0	2.2
Adaptimmune ($)	349%	0.7	0.8
Note: Market cap brackets set as of Jan 1, 2020. Source: EvaluatePharma.

 

Biggest share price fallers of 2020
Company	Share price loss	Market cap loss ($bn)	Market cap at Dec 2020 ($bn)
Big pharma
Glaxosmithkline (£)	-25%	-24.9	87.4
Merck & Co ($)	-12%	-24.6	207.0
Bristol Myers Squibb ($)	-10%	-10.1	140.4
Big drug makers (+$25bn)
Bayer (€)	-34%	-19.2	56.0
Fresenius (€)	-24%	-10.4	20.3
Biogen ($)	-17%	-15.9	37.7
Mid-caps ($5-25bn)
Amarin ($)	-76%	-5.8	1.9
Galapagos (€)	-57%	-7.1	6.2
Reata ($)	-40%	-3.2	7.4
Small caps ($250m-5bn)
Aprea Therapeutics (SKr)	-90%	-0.9	0.1
Tricida ($)	-81%	-1.5	0.4
Nextcure ($)	-81%	-1.0	0.3
Note: Market cap brackets set as of Jan 1, 2020. Source: EvaluatePharma.  https://www.evaluate.com/vantage/articles/news/snippets/biopharmas-stock-market-winners-and-losers-2020

UK doctors call for shorter gap between Pfizer vaccine doses

 A group of British doctors have written to England’s chief medical officer to tell him to cut the gap between doses of the Pfizer and BioNTech vaccine to six weeks from up to 12.

Britain is prioritising giving first doses of COVID-19 vaccine, allowing up to 12 weeks before a second dose, to give the maximum number of people some initial protection.

But Pfizer and BioNTech have warned they have no evidence their vaccine would continue to be protective if the second dose is given more than 21 days after the first.

The British Medical Association (BMA) said in a statement emailed on Saturday that it has written to the Chief Medical Officer (CMO) for England Chris Whitty.

The BMA said it supports giving a second dose up to 42 days after the first dose, but that a longer gap is not in line with World Health Organization guidance.

It therefore urged the CMO to “urgently review the UK’s current position of second doses after 12 weeks”.

“The UK’s strategy has become increasingly isolated from many other countries,” the BMA said.

“BMA members are also concerned that, given the unpredictability of supplies, there may not be any guarantees that second doses of the Pfizer vaccine will be available in 12 weeks’ time.”

Whitty told a media conference on Friday that the longer gap between doses was a “public health decision” aimed at vaccinating many more people and based on a belief that the great majority of protection comes from the first jab.

Britain is using two vaccines, one from Pfizer and the other from AstraZeneca.

AstraZeneca has supported the gap between its jabs, saying data showed an 8-12 week gap was a “sweet spot” for efficacy.

The Department of Health and Social Care said in an emailed statement that its priority was to protect as many people as possible as quickly as possible.

“The decision...to change vaccine dosage intervals followed a thorough review of the data and was in line with the recommendations of the UK’s four chief medical officers,” a DHSC spokeswoman said.

Some 5.38 million people have been given a first dose of vaccine in the UK, government data showed.

https://www.reuters.com/article/us-health-coronavirus-vaccine-britain/uk-doctors-call-for-shorter-gap-between-pfizer-vaccine-doses-idUSKBN29S07V

French health body urges delaying 2nd COVID shot to 6 weeks after 1st

 France’s top health advisory body on Saturday recommended doubling the time between people being given the first and second COVID-19 vaccinations to six weeks from three in order to increase the number getting inoculated.

The gap between the first and second injection in France is currently three weeks for people in retirement homes, who take priority, and four weeks for others such as health workers.

The Haute Autorite de Sante (HAS) said spacing out the two required vaccinations of the Pfizer/BioNtech and Moderna vaccines would allow the treatment of at least 700,000 more people in the first month.

“The growing number of infections and the worrying arrival of new variants call for an acceleration of the vaccination campaign in order to prevent the epidemic from spiking in coming weeks,” the HAS said in a statement.

The HAS said that while there is no agreement between different countries about the optimal timelag between the two shots, it seemed reasonable to delay the second injection to six weeks as the first shot would already provide protection against the coronavirus from the 12th or 14th day after the injection.

It added it was essential for people to get a second injection.

The HAS is an independent advisory body whose recommendations can inspire government policy but don’t automatically translate into action.

The World Health Organization said early this month that people should get two doses of the Pfizer/BioNTech vaccine within 21 to 28 days.

Several countries are considering ways to stretch scarce supplies of COVID-19 vaccines, including by delaying dosing intervals or reducing dose sizes.

In Britain, regulators have ruled that shots can be administered up to 12 weeks apart, though a group of British doctors have written to England’s chief medical officer to tell him to cut the gap between doses of the Pfizer/BioNTech vaccine to six weeks.

Pfizer and BioNTech have warned they have no evidence their vaccine would continue to be protective if the second dose is given more than 21 days after the first.

https://www.reuters.com/article/us-health-coronavirus-france-vaccine/french-health-body-recommends-delaying-second-covid-shot-to-six-weeks-after-first-idUSKBN29S0C6