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Wednesday, February 9, 2022

For Mirati Kras gives and it takes away

 It took a major biotech market retrenchment to bring about, but the Kras bubble might have just burst. As a result Mirati was punished heavily, losing 12% of its value yesterday. The trigger for the selloff was this week’s earnings from Amgen, which contained a fourth-quarter Lumakras revenue number of $45m, about $15m short of some analysts’ estimates and up only 25% over the third quarter. Full-year sales of $90m missed Evaluate Pharma consensus estimates of $103m, and the implication is that the drug is already stalling, barely six months into its launch. While the miss could be down to Covid, the worrying aspect was Amgen nearly halving its estimate of addressable US second-line NSCLC patients with the Kras G12C mutation, from 13,000 to just 7,000. While the front-line opportunity is still thought to number 25,000, it seems that far fewer patients than previously thought are making it to the second line. This alarming inference meant that Mirati was unable to capitalise on an important lifeline Amgen has given it, and instead the focus falls on just how much analysts now need to slash from adagrasib’s forecasts (Amgen hold-up gives Mirati a vital lifeline, February 8, 2022).

Kras inhibitor sales forecasts before Amgen's Lumakras miss ($m)
  2021e2022e2023e2024e2025e2026e
Lumakras
Amgen
103*
381
682
1,029
1,403
1,776
Adagrasib 
Mirati
0
60
258
645
1,127
1,676
Note: *actual 2021 figure was $90m. Source: Evaluate Pharma.

https://www.evaluate.com/vantage/articles/news/corporate-strategy-snippets/mirati-kras-gives-and-it-takes-away

Pfizer’s $100bn question

 How did Pfizer allow investor expectations to run so far ahead of reality? The group nearly doubled sales in 2021 thanks to its Covid products, and is expecting to bring in $100bn next year – but shareholders, apparently looking for higher profit guidance, sent its stock down 3% yesterday.

It is undeniable that the Covid sales are astounding, and the table below shows how Comirnaty and Paxlovid stack up against some of the other big beasts of biopharma, both past and present. But Pfizer’s base business is distinctly lacklustre and has been marred by several recent setbacks. The company needs to do deals, and gave some clues about its thinking during yesterday's fourth-quarter earnings call.

Pfizer is not ruling out big buys, but plans to shy away from acquisitions driven by cost synergies, echoing comments it made two years ago, pre-Covid (New Pfizer, same problem, January 29, 2020).

However, deal bankers should not get too excited just yet. Pfizer execs also noted more than once than some of the group’s “best successes” have come from fairly inexpensive tie-ups.

In general, Pfizer is looking for projects with the “potential to be real breakthroughs”, be they late or early stage. Its preference is for assets in areas where it already has a presence and can add value, including oncology, inflammation/immunology, rare diseases, vaccines and internal medicine, which includes cardiovascular and metabolic diseases.

Covid booster

It could take a while for any future deals to make an impact. In the meantime, Pfizer at least has its monster Covid sales to fall back on. 

The mRNA vaccine Comirnaty made $36.8bn last year – easily the biggest one-year total ever seen in biopharma, and above even future forecasts for Merck & Co’s cancer juggernaut Keytruda. And Pfizer is now saying the Covid vaccine will bring in $32bn in 2022, up from previous guidance of $29bn.

Hitting the big time: biopharma's record annual sales
ProductCompanyPeak annual sales in $bn (year) Note
ComirnatyPfizer36.8  (2021) Potential for 2022 to be higher; current guidance $32bn
KeytrudaMerck & Co29.2  (2028) Key patent expires in 2028
PaxlovidPfizer22.0  (2022) Current guidance; potential for further upgrades 
HumiraAbbvie20.7  (2021) Peak achieved 
SpikevaxModerna18.5  (2022) Current guidance; potential for further upgrades 
OpdivoBristol Myers/Ono14.3  (2028) Key patent expires 2028
EliquisBristol Myers Squibb14.0  (2025) Key patent expires 2026
HarvoniGilead Sciences13.9  (2015) Peak achieved 
LipitorPfizer13.8  (2006)*Peak achieved 
RevlimidBristol Myers Squibb12.8  (2021) Peak achieved 
*Includes sales booked by global partners. Source: Evaluate Pharma. 

As for the oral antiviral Paxlovid, which gained emergency use authorisation at the end of December, Pfizer expects $22bn this year. This disappointed some investors, who had hoped for $30bn-plus. However, the numbers for both Comirnaty and Paxlovid look certain to rise, as projections are based on contracts signed or committed to by late January.

When questioned about Pfizer’s conservatism over Paxlovid the group’s chief executive, Albert Bourla, said the forecast represented “only a very small fraction” of the 120 million Paxlovid doses it plans to manufacture this year.

Profitability could also be weighing on investors’ minds. Shareholders had been expecting 2022 earnings guidance of around $10 per share, but this came in at $6.35-6.55. One problem, according to Evercore ISI’s Umer Raffat, is that Comirnaty is becoming less profitable as Pfizer signs more contracts outside the US. He estimated that Comirnaty’s profit margin has dipped to around 35%, from around 40% throughout 2021.

If Paxlovid sales do substantially beat the current forecast this should help make up for the shortfall, since margins for this product are much higher – so the pressure is on the oral antiviral.

Oral versus injectable

Paxlovid’s performance could also have a direct impact on the fortunes of Glaxosmithkline, whose Vir-partnered Covid antibody Xevudy (sotrovimab) was a rare bright spot in that group’s fourth-quarter earnings today.

Xevudy sold £958m ($1.3bn) last year, mostly in the fourth quarter as it benefitted from its efficacy against the Omicron variant, where Regeneron’s and Lily’s antibodies have fallen down.

In 2022 Glaxo is guiding for Xevudy sales of $1.4bn, based on contracts signed so far. But on a media call today the group’s chief executive, Emma Walmsley, gave a nod to Paxlovid, admitting that there was a “significant oral medicine market coming through”.

As the year goes on it should become apparent how the market will shake out – and how long these Covid cash cows can be relied on. As the pandemic fades the pressure to do deals will only intensify.

https://www.evaluate.com/vantage/articles/news/corporate-strategy/pfizers-100bn-question

IGM Biosciences Advances Antibody to Clinical Trials for Treatment, Prevention of COVID-19

 IGM Biosciences, Inc. (Nasdaq: IGMS), a clinical-stage biotechnology company focused on creating and developing engineered IgM antibodies, today announced its progress in two Phase 1 clinical trials evaluating IGM-6268, an anti-SARS-CoV-2 IgM monoclonal antibody, for the treatment and prevention of COVID-19. The first, a Phase 1 clinical trial in the U.S., is a multi-center, randomized, double-blinded, placebo-controlled single (SAD) and multiple (MAD) ascending dose study to assess the safety, tolerability, and pharmacokinetics of IGM-6268 administered intranasally in healthy volunteers. The first two dose cohorts of healthy volunteers have been successfully cleared in the U.S., and data from the study are expected in the first half of 2022. The second, a Phase 1a/1b clinical trial in South Africa, is a multi-center, randomized, double-blinded, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of IGM-6268 administered intranasally first in healthy volunteers, once an appropriate dose cohort has been cleared, in outpatients with mild to moderate COVID-19. The first dose cohort of healthy volunteers has been cleared in the South Africa study, and data from the study are expected in mid-2022.

IGM today also announced that results from in vitro pseudovirus testing conducted by a widely recognized, commercial laboratory indicate that IGM-6268 exhibits neutralization of the Omicron (B.1.1.529) variant at an IC50 of 230 ng/mL, as well as potent in vitro neutralization activity against all other SARS-CoV-2 Variants of Concern (VoC) and Variants of Interest (VoI) tested to date, including the Delta variant. This indicated IC50 for the Omicron variant is expected to be well below the concentrations achievable by intranasal administration in key sites of infection and viral replication, based on previous observations from animal studies. These results expand upon data previously published in Nature, in which IGM-6268 exhibited significantly increased potency against wild type SARS-CoV-2 relative to an IgG antibody with the same binding domains and exhibited potent neutralization against the Alpha (B.1.1.7), Gamma (P.1), and Beta (B.1.351) variants, as well as other receptor-binding domain mutants that conferred resistance to several IgG antibodies authorized for emergency use.


GlaxoSmithKline 4Q Net Profit Grew on Higher Sales

 British pharmaceutical giant GlaxoSmithKline PLC on Wednesday posted an increase in net profit and sales for the final quarter of 2021.

The company said net profit was 749 million pounds ($1.01 billion) for the fourth quarter, up from GBP677 million for the same period the previous year, on sales that grew to GBP9.53 billion from GBP8.74 billion.

While sales beat expectations, net profit came short of a company-provided consensus, which saw the metric at GBP1.19 billion.

Earnings per share grew to 14.7 pence from 13.6 pence, while adjusted earnings per share--a closely-watched metric that strips off some one-off items--came to 25.6 pence, beating consensus expectations of 23.8 pence.

The company declared a dividend of 23 pence for the fourth quarter and of 80 pence for 2021, in line with what the company had previously said.

Sales in the pharmaceuticals business grew on year in the fourth quarter, driven by growth in the new and specialty products section, Glaxo said.

Vaccine sales, however, took a hit from lower meningitis and shingles shot sales, coming in 7% lower than in the previous year, the company said.

Turnover in the consumer healthcare business rose in the quarter, the company said.

Glaxo said it expects to deliver sales growth in 2022 of between 5% to 7% at constant exchange rates. Adjusted operating profit is expected to grow between 12% and 14% at constant exchange rates during the year, including some anticipated benefit in royalty income from the Gilead settlement.

Glaxo's vaccines business, which includes growth-driving shingles jab Shingrix, is expected to see sales growth in a low-teens percentage at constant exchange rates for the year.

However, the company warned that governments' prioritization of Covid-19 vaccination programs as well as measures to curb the pandemic are going to continue disrupting adult vaccinations, and that it expects the impact of this to be felt in the first half of the year. It still expects Shingrix to deliver double-digit growth with strong demand in both existing and new markets, Glaxo said.

Glaxo said it expects its Covid-19 solutions business to contribute to 2022 sales in a similar proportion to what it did in 2021. However, it foresees a substantially reduced profit contribution from the business, due to the increased sales proportion of lower-margin Covid-19 drug Xevudy.

Glaxo said it continues to expect the demerger of its consumer healthcare business to happen in mid-2022, and that it will give more information on this during its capital markets day on Feb 28.

https://www.marketscreener.com/quote/stock/GLAXOSMITHKLINE-PLC-9590199/news/GlaxoSmithKline-4Q-Net-Profit-Grew-on-Higher-Sales-Update-37823209/

COVID-19 vaccines, prescriptions fuel strong quarter at CVS

 COVID-19 vaccines and the return of customers to stores helped push CVS Health well past fourth-quarter earnings expectations.

But the pandemic's unpredictability is making the drugstore chain and pharmacy benefit manager cautious. It did not raise a 2022 forecast it laid out in December, and its shares slid on Wednesday.

Vaccines that boosted fourth quarter sales could drop as much as 80% in the new year, and company executives expect a decline in in-store diagnostic testing as well. Plus they don't know if there will be another surge in cases or another round of vaccine boosters in 2022.

COVID-19's impact “remains one of the most challenging aspects of developing our guidance,” Chief Financial Officer Shawn Guertin told industry analysts Wednesday.

The pandemic's impact was clear in the recently concluded fourth quarter, which saw CVS Health's profit jump 33% to nearly $1.3 billion compared with the final quarter of 2020.

The largest revenue generator for CVS, the pharmacy benefit management business, processed more pharmacy claims due partly to COVID-19 vaccinations and an increase in new prescriptions compared to the final quarter of 2020.

Vaccines had just started rolling out at the end of 2020, and many people were still staying home and trying to avoid the virus by staying away from doctor's offices that generate those prescriptions.

The pharmacy benefit management business runs prescription drug plans for large employers and other big clients. CVS Health also saw the number of prescriptions filled in another key part of is business — drugstores — jump more than 11% in the final quarter of 2021.

The company also administered more than 20 million COVID-19 vaccines in the quarter, as customers sought boosters and eligibility expanded to children in the United States.

Demand for COVID-19 tests customers could buy over the counter, or without a prescription, also spiked in the fourth quarter as the omicron variant of the virus surged.

CVS Health sold 22 million of those tests last year, and 70% of those sales came in the fourth quarter, CEO Karen Lynch said.

CVS Health operates one of the nation’s largest drugstore chains with nearly 10,000 retail locations. It also sells health insurance through its Aetna business that provides coverage for more than 23 million people.

That segment saw revenue jump 8% as it added more customers with government-funded Medicare Advantage coverage. It also spent less on COVID-19 testing and treatment.

Overall, CVS Health Corp. posted adjusted earnings of $1.98 per share in the fourth quarter, as total revenue grew 10% to $76.6 billion.

Analysts expected earnings of $1.83 per share on $75.66 billion in revenue, according to FactSet.

CVS Health said in December that it expected adjusted earnings of $8.10 to $8.30 per share in 2022.

Analysts forecast, on average, earnings of $8.27 per share.

Shares of the Woonsocket, Rhode Island, company fell more than 4% to $105.82 while broader indexes climbed Wednesday.

The price of CVS Health shares has already climbed about 50% over the past year.

https://www.marketscreener.com/quote/stock/CVS-HEALTH-CORPORATION-12230/news/COVID-19-vaccines-prescriptions-fuel-strong-quarter-at-CVS-37825101/

Bausch Health - Solta Medical Files Registration Statement for Proposed IPO

 Bausch Health Companies Inc. (NYSE/TSX: BHC) ('Bausch Health' or the 'Company') announced that its wholly owned subsidiary, Solta Medical Corporation ('Solta'), has publicly filed a registration statement on Form S-1 (the 'Registration Statement') with the U.S. Securities and Exchange Commission (the 'SEC') relating to a proposed initial public offering ('IPO') of Solta's common shares. The number of shares to be offered and the price range for the proposed offering have not yet been determined. Solta has applied to list its common shares on the Nasdaq Global Select Market under the symbol 'SLTA.'

Bausch Health has completed all internal procedural steps and is fully prepared to launch both the Solta and Bausch + Lomb Corporation IPOs, subject to receipt of regulatory, stock exchange and other approvals. The Company is actively monitoring market conditions to determine the paths forward.

Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. Citigroup, Guggenheim Securities, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

https://www.marketscreener.com/quote/stock/BAUSCH-HEALTH-COMPANIES-I-44965075/news/Bausch-Health-Companies-Solta-Medical-Corporation-Files-Registration-Statement-for-Proposed-Initia-37826323/

Aptevo Earns $10M Milestone, Provides Company Update

 Aptevo Therapeutics Inc. ("Aptevo" or the "Company") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIR™ and ADAPTIR-FLEX™ platform technologies, today announced that the Company has earned a $10 million non-dilutive milestone payment related to 2021 sales of RUXIENCE®. Additionally, based on RUXIENCE 2021 fourth quarter and full-year sales results, the Company is optimistic about the possibility of earning additional non-dilutive milestones totaling $22.5 million over the next two years. The Company also announced that its Phase 1b trial evaluating lead drug candidate APVO436 for the treatment of acute myeloid leukemia (AML) continues to enroll new clinical trial sites and that the first complete remission patient, announced in 2021, is proceeding to transplant.

https://finance.yahoo.com/news/aptevo-therapeutics-earns-10-million-130500275.html