Vaxart: Implied upside of 140%

 There are close to 2,000 small-cap stocks and securities for investors to choose from. However, Wall Street professionals believe you'll have a hard time topping the potential 140% return over the next year from clinical-stage biotech stock Vaxart (NASDAQ:VXRT).

The Vaxart rags-to-riches story will come down to how well the company's coronavirus disease 2019 (COVID-19) treatment option, VXA-CoV2-1, fares in clinical studies. What makes this treatment so unique is that it's a tablet, rather than a shot, which could play a key role in overcoming vaccine resistance and administration. After all, you don't need trained medical personnel to administer to a tablet.

At the beginning of February, Vaxart announced a positive first step for VXA-CoV2-1 in a phase 1 trial. Preliminary data showed it had reached all of its primary and secondary safety and immunogenicity endpoints. Plus, there were early signs it could be effective against the original and variant strains of COVID-19. 

It's far too early to tell if Vaxart's oral COVID-19 treatment will be a success in mid-or-late-stage trials, but it certainly offers game-changing potential if it is effective.

https://www.fool.com/investing/2021/04/27/5-small-cap-stocks-60-to-140-upside-wall-street/

Aldeyra: Positive clinical results for lead pipeline candidate

 Shares of Aldeyra Therapeutics (NASDAQ:ALDX) were soaring 26.6% higher as of 10:54 a.m. EDT on Tuesday. The big jump came after the company announced positive top-line results from a late-stage study evaluating reproxalap in treating allergic conjunctivitis, inflammation of the eyes caused by allergies.

Biotech stocks usually rise on positive clinical results. But the really big gains come when the results are especially good. That's the case for Aldeyra.

Reproxalap easily achieved the primary endpoint of the study (reduction in eye itching) with a high level of statistical significance. It also achieved all of the secondary endpoints of the study with high levels of statistical significance.

The results were exactly what investors were hoping for. They weren't really surprising, though. Aldeyra previously reported positive results from another late-stage study of reproxalap in treating allergic conjunctivitis.

More than 66 million people in the U.S. are affected by allergic conjunctivitis. While some treatments are available, there hasn't been a new therapeutic mechanism in decades. 

Aldeyra's next step is to meet with the U.S. Food and Drug Administration (FDA) about a path to approval for reproxalap. This meeting is expected to take place in the second half of this year, with a potential regulatory filing for approval on the way afterward.

https://www.fool.com/investing/2021/04/27/why-aldeyra-therapeutics-stock-is-soaring-today/

Stryker misses on first quarter 2021

 Stryker (NYSE:SYK) reported operating results for the first quarter of 2021:

The response to the COVID-19 pandemic has included measures to slow the spread of the virus taken by governments and health care authorities globally, including the postponement of elective medical procedures and social contact restrictions. While there is starting to be some recovery in certain geographies, there continues to be a negative impact on our operations and financial results.

First Quarter Results

• Reported net sales increased 10.2% from 2020 and 12.4% from 2019 to $4.0 billion

• Organic net sales increased 1.8% from 2020 and 4.7% from 2019

• Reported operating income margin of 11.6%

• Adjusted operating income margin(1) contracted 50 bps to 23.5%

• Reported EPS decreased 39.2% to $0.79

• Adjusted EPS(1) increased 4.9% to $1.93

https://finance.yahoo.com/news/stryker-reports-first-quarter-2021-200500407.html

Illumina has $1B revenue Q1, strong guidance

 Illumina, Inc. (NASDAQ: ILMN) today announced its financial results for the first quarter of fiscal year 2021.

First quarter results reflect record revenue:

• Revenue of $1,093 million, a 27% increase compared to the prior year period

• GAAP net income for the quarter of $147 million, or $1.00 per diluted share, compared to $173 million, or $1.17 per diluted share, for the prior year period

• Non-GAAP net income for the quarter of $278 million, or $1.89 per diluted share, compared to $243 million, or $1.64 per diluted share, for the prior year period. Non-GAAP net income excludes acquisition-related expenses, primarily the Continuation Payments paid to GRAIL (see the "Reconciliation Between GAAP and Non-GAAP Net Income" table for a reconciliation of these GAAP and non-GAAP financial measures)

• Cash flow from operations of $282 million compared to $281 million in the prior year period

• Free cash flow (cash flow from operations less capital expenditures) of $240 million for the quarter compared to $241 million in the prior year period

"Illumina achieved its first billion-dollar revenue quarter in company history and delivered a very strong start to 2021, exceeding our expectations," said Francis deSouza, Chief Executive Officer. "Orders during the first quarter of 2021 reached an all-time high demonstrating strength in our core business across all regions, reflecting growth in both clinical and research customers. We are seeing tremendous progress in clinical market access and reimbursement for genomic applications increasing access to genomic testing for patients worldwide. We are proud of the significant contributions our customers, partners, and employees are making to the creation of a genomic epidemiology infrastructure to combat COVID-19, as well as monitor for future pathogen outbreaks for the benefit of global public health."

Gross margin in the first quarter of 2021 was 69.9% compared to 72.1% in the prior year period. Excluding amortization of acquired intangible assets and expenses related to COVID-19, non-GAAP gross margin was 70.5% for the first quarter of 2021 compared to 73.0% in the prior year period.

Updates since our last earnings release:

• Announced TSO 500 partnership with Kartos Therapeutics to advance comprehensive genomic profiling for blood cancers

• Published positive economic study results in partnership with Harvard Pilgrim Health Care demonstrating the cost-effectiveness of offering non-invasive prenatal testing (NIPT) to all pregnant women

• Illumina was selected among the top 100 influential global companies by Time magazine

• Published our second annual Corporate Social Responsibility report that highlights our commitment to society, our employees and the environment

• Completed a senior unsecured investment grade bond offering for an aggregate principal amount of $1 billion and finalized a $750 million 5-year unsecured revolving credit facility

• Announced Jay Flatley will step down from the Board of Directors and John W. Thompson will be appointed as the new Chair of the Board effective May 26, 2021

• Received medical device registration in Russia for NextSeq 550Dx and associated reagent kits

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2021, the company expects year-over-year revenue growth in the range of 25% to 28%, and now expects GAAP earnings per diluted share of $4.72 to $4.97 and non-GAAP earnings per diluted share of $5.80 to $6.05. Except for acquisition-related expenses and bridge facility fees incurred during Q1 2021, this guidance excludes the potential impact from the pending acquisition of GRAIL, which we expect to close in the second half of 2021.

Conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Tuesday, April 27, 2021. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (866) 211-4597 or 1 (647) 689-6853 outside North America, both using conference ID 4359912.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

https://finance.yahoo.com/news/illumina-reports-financial-results-first-200500053.html

Amgen started at Buy by Daiwa

 Target $300

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

Amgen Stock Dips On Lighter-Than-Expected First-Quarter Sales, Profit

Amgen stock dipped late Tuesday after the biotech giant reported adjusted income of $3.70 per share on $5.9 billion in sales for its first quarter ended March 31.

On average, analysts polled by FactSet expected Amgen (AMGN) to earn $4.04 per share and $6.27 billion in sales.

In the year-earlier period, Amgen earnings were $4.22 a share and sales were $6.16 billion.

For the year, Amgen guided to adjusted earnings of $16-$17 per share and $25.8 billion to $26.6 billion in sales. Analysts called for profit of $16.84 a share and $26.4 billion in sales.

In after-hours trading on the stock market today, Amgen stock fell a fraction near 255.10.

https://www.investors.com/news/technology/amgen-stock-amgen-earnings-q1-2021/?src=A00220

Novartis first-quarter sales, profit miss analyst expectations amid Covid

 Swiss drugmaker Novartis on Tuesday said first-quarter core net income fell 4%, missing analyst expectations, as Covid-19 related lockdowns and disruptions around the globe hit demand.

Core net income slipped to $3.4 billion, compared to the $3.5 billion average estimates of nine analysts in a poll by Refinitiv. Sales were 1% higher at $12.4 billion, compared to $12.5 billion forecast in the poll. Net income fell 5% to $2.06 billion.

Novartis confirmed its 2021 outlook, which foresees net sales growing at a low- to mid-single-digit percentage rate, with core operating income expected to grow at a mid-single-digit percentage rate, ahead of sales.

Novartis, like many other drugmakers including cross-town rival Roche, has taken a sales hit for drugs in dermatology, eye diseases and breast cancer treatment areas as people shy away from doctor visits during the prolonged pandemic. That is impacting key Novartis medicines including Cosentyx for psoriasis, Lucentis for macular degeneration, and Kisqali for breast cancer.

“There continues to be COVID-19 related lockdowns and disruptions in several geographies,” Novartis said, adding that the COVID-19 pandemic has also led to a historically weak cough and cold season for drugs made by its Sandoz generics unit.

The Sandoz unit, where sales fell 9% to $2.3 billion in the period, now expects revenue for the full year to decline in the low- to mid-single-digit percentages.

https://www.cnbc.com/2021/04/27/novartis-first-quarter-earnings-miss-expectations-amid-covid-impact.html