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Thursday, December 2, 2021

Veeva Tumbles On Light 2023 Sales Outlook Despite Quarterly Beat

Medical software company Veeva Systems (VEEV) offered a slightly short view for fiscal year 2023 sales, and VEEV stock plunged late Wednesday.

The dive came hours after officials announced the first Covid case in the U.S. due to the omicron variant. Stocks broadly tumbled. During the regular session, VEEV stock closed at 272.12, down 3.7%. That continued in after-hours trading as shares toppled another 5.2%.

For the fiscal year ending in January 2023, Veeva expects $2.15 billion to $2.17 billion in sales. But that was well below analyst forecasts for $2.185 billion in sales.

VEEV Stock Tumbles On Outlook

Ultimately, third-quarter metrics beat VEEV stock analysts' predictions.

On an adjusted basis, Veeva earned 97 cents a share and reported $476.1 million in sales. Profit climbed more than 24% year over year and beat projections for 88 cents. Sales increased 26% and topped calls for $466 million.

Subscriptions brought in $380.7 million in sales, also up 26% vs. the year-earlier period.

Guidance for fourth-quarter sales came in slightly low, however. Veeva expects $478 million to $480 million in sales. The high end of the guidance touched VEEV stock analysts' call for $480 million. Adjusted profit guidance for 88 cents a share was 2 pennies above estimates.

For the fiscal year ending Jan. 31, Veeva expects adjusted income of $3.69 per share and $1.843 billion to $1.845 billion in sales. The profit outlook handily topped VEEV stock analysts' view for $3.58. The sales guidance was narrowly above forecasts for $1.835 billion.

https://www.investors.com/news/technology/veev-stock-dives-despite-quarterly-beat-as-us-omicron-case-slams-wall-street/

Leerink Partners Stick to Their Buy Rating for Aurinia

 Leerink Partners analyst Joseph Schwartz maintained a Buy rating on Aurinia Pharmaceuticals (NASDAQ:AUPH) on Tuesday, setting a price target of $35, which is approximately 85.77% above the present share price of $18.84.

Schwartz expects Aurinia Pharmaceuticals to post earnings per share (EPS) of -$0.39 for the fourth quarter of 2021.

The current consensus among 5 TipRanks analysts is for a Moderate Buy rating of shares in Aurinia Pharmaceuticals, with an average price target of $33.
The analysts price targets range from a high of $40 to a low of $23.

In its latest earnings report, released on 09/30/2021, the company reported a quarterly revenue of $14.67 million and a net profit of -$50.35 million. The company's market cap is $2.44 billion.

https://www.investing.com/news/leerink-partners-stick-to-their-buy-rating-for-aurinia-pharmaceuticals-2695518

T-cell test bronze goes to Qiagen

 Qiagen today became the third company to launch a T-cell-based test for prior Covid-19 infection and also to assess individuals’ response to vaccination. The Quantiferon Sars-Cov-2 assay, which detects CD4+ and CD8+ T-cell responses elicited by the virus, is now available in Europe, joining Perkinelmer’s T-Spot Discovery Sars-CoV-2 product. Neither of these is yet available in the US, however, where the only T-cell test with FDA emergency authorisation is Adaptive Biotechnologies’ T-Detect Covid assay. Qiagen says its blood test, which has grown out of the Dutch group’s year-old collaboration with Tscan Therapeutics, is differentiated from the competition as it does not require a purification step for the lymphocytes. Testing for Covid-19-reactive T-cells is believed to be a useful adjunct to antibody testing since the response declines more slowly than antibody response, but also appears beforehand, since CD4+ T-cells help B cells generate anti-Covid antibodies. Quantiferon Sars-Cov-2 could indicate how severe the course of a Covid infection will be, according to Qiagen, as well as how long immunity might last. But there is as yet no definitive evidence linking T-cell readings to resistance to subsequent infection with Covid-19. 

Marketed Covid-19 T-cell tests
CompanyTestStatus 
PerkinelmerT-Spot Discovery Sars-CoV-2CE marked Mar 2021; awaiting US EUA
Adaptive BiotechnologiesT-Detect Covid US EUA granted Mar 2021
QiagenQuantiferon Sars-Cov-2CE marked Dec 2021
Source: FDA, company releases.\

https://www.evaluate.com/vantage/articles/news/policy-and-regulation-snippets/t-cell-test-bronze-goes-qiagen

Novartis gets in on alpha-synuclein

 Novartis is hardly known for novel CNS projects. But today the group took a punt on a potentially disease-modifying mechanism for Parkinson’s, via a deal with UCB. The target, alpha-synuclein, has had its fair share of setbacks, with Roche and Prothena last year reporting mixed data with their antibody, prasinezumab, and Biogen this year discontinuing BIIB054. At least Novartis has not paid top dollar: the company is giving UCB $150m up front, although it is on the hook for up to $1.5bn in milestones. In return, the Swiss company gets global co-development and co-commercialisation rights to UCB0599, an oral, brain-penetrant alpha-synuclein misfolding inhibitor, and an option on UCB7853, an anti-alpha-synuclein antibody. The two projects could complement each other, UCB noted. As well as Roche and Prothena, which are pressing on with prasinezumab, other companies looking at this target include include AC Immune, which struck its own deal here in July. Annovis Bio’s ANVS401, meanwhile, inhibits amyloid-beta and tau as well as alpha-synuclein – that group is planning phase 3 trials in both Parkinson’s and Alzheimer’s, but phase 2 data have been far from convincing.

Alpha-synuclein-targeting projects in clinical development
ProjectCompanyDescriptionTrial details
Phase 2
ANVS401Annovis BioSmall molecule amyloid precursor protein, alpha-synuclein & Tau inhibitorPh2 PD data reported Oct 2021, ph3 planned
Prasinezumab (PRX002/RO7046015)Prothena/RocheAnti-alpha-synuclein MabPD: Ph2 Pasadena failed, Ph2b Padova began May 2021
ENT-01EnterinSmall molecule alpha-synuclein aggregation inhibitorPh2 Karmet in PD-related constipation completed Jul 2021; Ph2 planned in PD+psychosis & PD+dementia
Lu AF82422Lundbeck/GenmabAnti-alpha-synuclein MabAmulet in multiple system atrophy completes May 2023
UCB0599Novartis/UCB (licensed from Neuropore Therapies)Small molecule alpha-synuclein misfolding inhibitorPh2 in PD completes Jul 2024
Phase 1
ACI-7104 (PD01 )AC Immune (via Affiris)Anti-alpha-synuclein vaccinePh1 completed, ph2 to start "shortly"
MEDI341 (TAK-341)Astrazeneca/TakedaAnti-alpha-synuclein MabMAD trial in PD completes Jul 2022
ION464 (BIIB101)Biogen/IonisAlpha-synuclein antisenseHorizon in multiple system atrophy completes Jul 2022
UB-312VaxxinityAnti-alpha-synuclein vaccinePh1 in healthy volunteers & PD pts completes Dec 2022
UCB7853 UCB (Novartis has option)Anti-alpha-synuclein MabPh1 in healthy volunteers & PD pts completes Jun 2023
ABBV-0805Abbvie/BioarcticAnti-alpha-synuclein MabPh1 withdrawn for "strategic reasons", project still listed on pipeline
Source: Evaluate Pharma & clinicaltrials.gov.

https://www.evaluate.com/vantage/articles/news/deals-snippets/novartis-gets-alpha-synuclein

Vor started at Outperform by Oppenheimer

 Target $30

https://finviz.com/quote.ashx?t=vor

First omicron cases detected in India

 India on Thursday confirmed its first cases of the omicron COVID-19 variant in two men who returned from international travel. 

The men, 66 and 46, tested positive for the variant in the southern Indian state of Karnataka and are under observation, according to The Associated Press. It is not known which country they traveled to or whether or not they were vaccinated. 

All contacts of the men have reportedly been traced and tested for the virus. 

Balram Bhargava, head of the Indian Council of Medical Research, the country's top medical research organization, urged people to get vaccinated as soon as possible. 

“Increased vaccine uptake is the need of the hour. Don’t delay in getting fully vaccinated,” he said, according to the AP.

Several countries have already been classified by officials in India as "at risk" in response to the variant, which the World Health Organization said poses a “very high” risk of infection. Travelers from the "at risk" countries are reportedly tested upon arrival to India. In addition, 2 percent of international travelers are also randomly selected for COVID-19 testing.

Health policy expert Dr. Chandrakant Lahariya told the AP that the focus should be on making sure unvaccinated residents receive the jab.

“Some of the hesitancy may disappear on the news of the new variant," he said. "But this can’t be taken for granted."

Some states in India have also enforced strict restrictions on international arrivals, including mandatory COVID-19 tests for travelers from South Africa, Botswana and Hong Kong, the news service noted.

More than 57 percent of Indians have received at least one dose of a COVID-19 vaccine, with 33 percent fully vaccinated and 24 percent having received a single jab, according to Our World In Data. 

https://thehill.com/policy/international/583965-first-omicron-cases-detected-in-india

  

Biden to announce insurance reimbursements for at-home COVID-19 tests

 Biden will announce Thursday that Americans with private insurance will be able to receive reimbursements for at-home COVID-19 diagnostic tests as part of a broader plan to combat the omicron and delta variants.

The White House said that departments of Health and Human Services, Labor and the Treasury will issue guidance by mid-January clarifying that Americans with private insurance will be able to seek reimbursement for the costs of the at-home tests during the public health emergency.

A senior administration official said that the new policy would impact some 150 million Americans who have private insurance. The reimbursement is not expected to be retroactive, but officials are still working out the specifics of the policy.

Additionally, Biden will announce plans to expand access to free at-home tests in underserved communities in the U.S. The administration plans to distribute 25 million more free tests to community sites, on top of the 25 million Biden already committed. The administration is also adding rural clinics to the list of sites that will receive the free tests.

Health experts say that increased COVID-19 testing, in addition to the push for vaccines, will be key to confronting the virus and its more transmissible variants.

Biden is scheduled to lay out the White House’s multi-step plan in a speech at the National Institutes of Health Thursday afternoon. He will also announce other steps, like stricter testing rules for international travelers entering the U.S. and an extension of the TSA’s mask mandate for domestic transit.

The first known case of the omicron variant in the U.S. was detected Wednesday in California. Officials are rushing to understand more about the variant, including its transmissibility, severity and the degree to which the COVID-19 vaccines protect against it. U.S. officials expect the vaccines to provide at least some protection and are urging Americans who have not done so to get vaccinated against COVID-19 or receive booster shots.

https://thehill.com/homenews/administration/583958-biden-to-announce-insurance-reimbursements-for-at-home-covid-19-tests