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Tuesday, August 25, 2020

Orthopaedics companies’ nightmare quarter

The Covid-19 pandemic has scythed vast sums from joint makers’ Q2 sales. But Medtronic’s summer earnings were better than those for its spring quarter.



When reporting their first quarter results three months ago, many medtechs warned that the second quarter would be pretty brutal. And for the majority this bleak forecast came true – but there were a few bright spots in the darkness. 

Two of the most prominent were Qiagen, whose Covid-19 diagnostics have sold so well they indirectly led to the cancellation of its $12.5bn takeover by Thermo Fisher Scientific, and Resmed, a maker of breathing devices that have been repurposed as ventilators for seriously ill Covid-19 patients. But many more companies have lost out – and in percentage terms the orthopaedics groups have had a real nightmare.

Zimmer Biomet has done worst of all, its revenues contracting 38% compared with the second quarter of 2019. The company was the only major medtech to fall into the red in the first quarter, a loss that nearly quadrupled to  $208m in the second quarter. The joint implant developer is heavily reliant on elective procedures, many of which have been cancelled or postponed during lockdown. 

Even so, Zimmer described this showing as better than expected, following the narrative established by companies including Johnson & Johnson and Abbott, which also said that elective procedure volumes had bounced back faster than expected. And lost sales could yet be recouped: Zimmer estimates that its backlog of deferred patients represents $700-800m of future revenue. 

Realising this will depend on patients and doctors feeling it is safe to go ahead. With the virus constantly threatening to erupt once more and employment – and thus insurance – on the downswing it would be unwise to count on these sales appearing in the short term.

While J&J’s total second-quarter sales were only down 11% year-on-year, its medical device wing did poorly, with revenues down 34% on the same period last year. J&J was the only company that raised its full-year guidance from the reduced figure it gave in April – though at $80-81bn this was some way behind the $85-86bn it had initially forecast in January. 

How Covid-19 has affected selected ortho companies
Date of earningsCompanyQ2 2020 sales ($bn)Change from Q2 2019Q2 2020 profit (loss) ($m)
August 4Zimmer Biomet1,226 (38%) (208)
July 16Johnson & Johnson*4,288 (34%)3,626
August 4Nuvasive204 (30%) (50)
July 29Smith & Nephew901 (30%)172
July 30Stryker2,764 (24%) (83)
August 5Globus Medical149 (23%) (21)
*Medtech-only sales; profit for entire group. Source: company communications.

Among cardiovascular companies there was likewise little cheer. Both Boston Scientific and Edwards Lifesciences slipped from profit in the first quarter of 2020 to a loss in the second. Boston did not provide any full-year guidance, having withdrawn it in April; Edwards’ full-year guidance, which had been cut in the spring, was unchanged at $4-4.5bn.

Medtronic, reporting its first-quarter fiscal 2021 results today, echoed the faster-than-expected recovery line. Its sales were down 12% compared with the first quarter of fiscal 2020. However, Medtronic was the only group among the big medtech cohort to do better in the summer than the spring: Medtronic’s fiscal fourth quarter sales, reported mid-May, were down 26% year-on year (Covid-19 takes a toll on medtech’s first quarter, May 21, 2020).

This is a good omen considering Medtronic’s odd reporting periods. Its spring quarter ran from February to April rather than January to March, and likewise the summer quarter is a month ahead of the vast majority of other medtech groups. The better performance Medtronic enjoyed in summer is a result of improving procedure volumes in July as hospitals reopened for many elective surgeries – other cardiovascular, surgical and ortho groups will be hoping to see the same trend in their current autumn quarters. 

Deep breath

The big winners, though, were active in other therapeutic areas. Diagnostics specialists Danaher and Qiagen both saw their second-quarter revenues climb 19% on the strength of their Covid-19 tests – though Danaher also benefited from the closure of its $21bn acquisition of GE Biopharma. Qiagen’s quarterly profit more than doubled year-on-year, and management will have to build on this if it is to chart a successful course as a standalone business (The Thermo-Qiagen saga comes to an end, August 13, 2020). 

Resmed also had a successful quarter – though this was not quite as good as its spring period. Reporting its third-quarter 2020 results in April, it said that sales of its respiratory devices, including the CPAP machines usually used to help sleep apnoea patients breathe at night but which were repurposed as ventilators for hospitalised Covid-19 patients, had risen 16% year-on-year. 

In its fourth quarter, sales were up 9% compared with the same period in 2019. This reflects the shift to milder infections in younger patients that seems to be happening during the current second wave of infections – as well as the fact that many hospitals are now well-stocked with ventilation devices. 

Other selected winners and losers
Date of earningsCompanyQ2 2020 sales ($bn)Change from Q2 2019Q2 2020 profit (loss) ($m)Focus
Jul 23Danaher5,29719%927Diagnostics
Aug 4Qiagen45219%90Diagnostics
Aug 5Resmed*7709%178Respiratory
Aug 25Medtronic**6,611 (12%)487Cardiology; surgery; neurology; orthopaedics
Jul 23Edwards Lifesciences925 (15%) (122)Cardiology
Jul 21Intuitive Surgical852 (22%)68Surgery
Jul 29Boston Scientific2,003 (24%) (147)Cardiology
*Resmed’s results for Q4 2020. **Medtronic’s results for Q1 2021. Source: company communications.


FDA OKs Amneal’s generic Lidoderm Patch

The FDA approves Amneal Pharmaceuticals’ (AMRX +1.1%) marketing application for its generic version of Endo Pharmaceuticals’ (ENDP -1.2%) Lidoderm Patch, 5% for the treatment of post-herpetic neuralgia.

Per IQVIA, the U.S. market is ~$282M.


Qualigen picks up a bull who sees a two-bagger after release of COVID-19 test

Alliance Global Partners upgrades Qualigen (QLGN +4.0%) to Buy with a $10 (107% upside) price target. In a note, analyst James Molloy regards the company as a “compelling opportunity” in cancer detection and treatment.

It currently markets its FastPack System for detecting prostate cancer, thyroid function and metabolic disorders. It plans to launch the FastPack PRO SARS-CoV-2 IgG antibody test this quarter.

Lead therapeutic candidate is AS1411, a G-rich oligonucleotide that binds to a protein called nucleolin that is present on the surface of cancer cells.


Oxford coronavirus vaccine data could go to regulators this year

Trial data for the University of Oxford and AstraZeneca’s possible coronavirus vaccine could be given to regulators this year but corners cannot be cut to speed up approval for emergency use, a scientist leading the trials said on Tuesday.

The Oxford vaccine produced an immune response in its first human trials, underlining its position as one of the leading candidates in the race to combat a virus that has led to hundreds of thousands of deaths and crippled the global economy.

“It is just possible that if the cases accrue rapidly in the clinical trials, that we could have that data before regulators this year,” Andrew Pollard, director of the Oxford Vaccine Group, told BBC Radio of progress in larger, late-stage trials.

“Then there would be a process that they go through in order to make a full assessment of the data.”

The trials hit the headlines earlier this week when the Financial Times reported the Trump administration was considering fast-tracking the vaccine for use in the United States ahead of the Nov. 3 presidential election.

One option being explored would involve the U.S. Food and Drug Administration (FDA) awarding “emergency use authorization” in October to the potential vaccine, the newspaper said.

Pollard said the process for emergency use authorisation was well established. “But it still involves having carefully conducted data … and evidence that it actually works,” he said.

The Financial Times reported that Washington was considering basing emergency approval of the vaccine on just a small UK study of around 10,000 people.

Pollard, the chief investigator of the global clinical trials of the vaccine candidate, said AstraZeneca would take the data to regulators once the scientists were satisfied with it.

He said Oxford had enrolled about 20,000 people in trials across Britain, Brazil and South Africa, with AstraZeneca leading a U.S. trial of 30,000 people.

“The size of the trials still isn’t the issue here, what you need is to have enough cases accruing during the time of observation in the trials,” Pollard said.


China to probe labs, farms in crackdown on illegal African swine fever vaccines

China has begun a strict crackdown on the production and use of illegal African swine fever vaccines, the Ministry of Agriculture and Rural Affairs said on Tuesday, after anecdotal evidence of the widespread use of such products.

China is trying to rebuild its hog herd after African swine fever killed millions of pigs in the country in 2018 and 2019.

There is no cure or approved vaccine anywhere in the world, but China is close to approving the first African swine fever vaccine and last week said it was expanding clinical trials on a promising candidate.

Illegally-produced vaccines have circulated in the market for months, however, and could complicate the introduction of an officially-approved product.

In May, the state-backed Legal Daily reported that police in Chongqing had arrested seven people found to be producing a fake African swine fever vaccine.

Beijing has previously cautioned against the use of illegal and fake vaccines and warned of strict punishment, but the new crackdown, begun on Monday, appears much more comprehensive.

Provincial authorities will carry out inspections at veterinary laboratories, drug producers and pig farmers for any evidence they could have developed or used an illegal vaccine.

Authorities must investigate veterinary laboratories used for research or commercial purposes and check any unlabelled vaccines and disease materials or reagents along with the records of experiments.

It also wants closer supervision of clinical trials and pilot production of vaccines to ensure there is no illegal transfer of the pilot product.

Provincial authorities will also inspect veterinary product manufacturers and pig breeders, checking immunisation records on farms and running tests on pigs to search for different strains of the swine fever virus.

Any strains with gene deletions could indicate a vaccine had been used and would be immediately investigated, they said.


Sinovac signs deal to supply COVID-19 vaccine in Indonesia

Sinovac Biotech Ltd. (NASDAQ:SVA) inks two agreements with Indonesia-based PT Bio Farma for the technology license, supply and local production of CoronaVac, its inactivated coronavirus vaccine candidate against COVID-19.

Under the contracts, SVA will supply bulk vaccine to Bio Farma to produce at least 40M doses in Indonesia before March 2021. It will continue to supply bulk product until the end of 2021.

Bio Farma is currently conducting a Phase 3 clinical trial in Bandung for CoronaVac.

Financial terms are not disclosed.


FDA accepts Merck KGaA tepotinib application for lung cancer

Under Priority Review status, the FDA accepts for review Merck KGaA (OTCPK:MKGAY) unit EMD Serono’s marketing application seeking approval of tepotinib for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a certain mutation that leads to mesenchymal-epithelial transition exon 14 (METex14) skipping, an aggressive type of NSCLC with a poor prognosis. It is a Breakthrough Therapy-tagged indication.

Tepotinib is a small molecule inhibitor of an enzyme called c-Met receptor tyrosine kinase. C-Met signaling is associated with aggressive treatment-resistant cancer.