AERI sees 16-25% growth in product revenue, NGM to release NASH trial data in 1H23, CCXI under watch

(RTTNews) – Here are some of the biotech companies that released quarterly results and provided an update on their pipeline progress on Thursday.

1. Aerie Pharmaceuticals Inc. (AERI) plans to initiate a Phase III registrational study for AR-15512 in dry eye disease in the second quarter of 2022.

An Investigational New Drug Application for AR-14034 in Wet Age-Related Macular Degeneration is expected to be submitted to the FDA in the second half of 2022.

For the three months ended March 31, 2022, the Company’s total net glaucoma franchise product revenue was $29.8 million, up 30% from $23.0 million in the quarter. previous.

Looking ahead to 2022, net revenues from Glaucoma Franchise products are expected to be between $130 million and $140 million, implying 16% to 25% growth over 2021.

AERI closed Thursday’s session at $7.72, down 4.69%.

2. agilon health inc. (AGL), which turned to profitability with revenue growth of 58% in the first quarter ended March 31, 2022, forecasts revenue growth of 37% to 42% for the full year 2022 .

For the first quarter of 2022, the company reported net income of $1 million compared to a net loss of $15 million in the first quarter of 2021. Total revenue for the first quarter of 2022 was $653 million compared to $413 million in the first quarter of 2021. .

The company forecast a revenue range of $640 million to $652 million for the second quarter and $2.51 billion to $2.59 billion for the full year 2022. Total revenue was $499 million in the second quarter of 2021 and $1.83 billion for the full year 2021.

The analyst consensus revenue estimate is $646.96 million for the second quarter and $2.59 billion for the full year 2022.

AGL closed Thursday’s session at $18.01, down 6.88%.

3. Akoya Biosciences Inc. (AKYA), which provides comprehensive single-cell imaging solutions, achieved record revenue for the first quarter ending March 31, 2022 and raised its revenue outlook for the ‘year.

Total revenue for the first quarter of 2022 increased 38% to $16.9 million from $12.2 million in the prior year period.

Adjusted net loss attributable to common shareholders was $16.4 million or $0.44 per share, compared to a loss of $8.08 million or $3.54 per share in the prior quarter.

For the full year 2022, the company now expects revenue of $70-73 million, up from its previous forecast of $69-71 million. Reported revenue in 2021 was $54.9 million.

AKYA closed Thursday’s session at $10.15, down 8.06%.

4. Anika Therapeutics Inc. (ANIK) has steered its overall fiscal 2022 revenue toward the upper end of its low to mid-single digit percent growth guidance range from 2021, at the light of continued healthy demand for its Osteoarthritis Pain Management Products and growing demand for its Joint Preservation and Restoration portfolio.

Previously, the company had forecast that overall revenue for fiscal year 2022 would grow by a low to mid-single digit percentage from 2021. Revenue for fiscal year 2021 was $147.8 million.

Adjusted net loss for the first quarter of 2022 was $1.6 million or $0.11 per share, compared to adjusted net earnings of $0.8 million or $0.06 per share in the quarter. the previous year. Revenue for the first quarter of 2022 increased 7% to $36.7 million from $34.3 million in the first quarter of 2021.

ANIK closed Thursday’s session at $20.56, down 6.97%.

5. ChemoCentryx Inc. (CCXI) has planned a few clinical trials to expand the use of its lead product TAVNEOS.

In the United States, TAVNEOS was approved last October as an add-on treatment for adult patients with severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis. The drug generated net sales of $5.4 million in the first quarter of 2022, compared to $1 million in the fourth quarter of 2021.

ChemoCentryx plans to initiate a clinical trial with TAVNEOS in lupus nephritis in the second half of 2022, pending FDA feedback in mid-2022.

The Company plans to initiate a Phase III clinical trial of TAVNEOS in patients with Hurley stage III (severe) hidradenitis suppurativa in the second half of 2022. A meeting with the FDA regarding this is scheduled for late September. second trimester.

Beyond TAVNEOS, the company is also exploring CCX559, a novel orally administered PD-L1 checkpoint inhibitor in development for the treatment of various cancers.

A phase Ib/II clinical trial to more directly measure the anti-tumor effects of CCX559 should be initiated during the second half of 2022.

CCXI closed Thursday’s session at $15.64, down 7.95%.

6. CareDx Inc. (CDNA), which reported revenue growth of 18% for the first quarter ended March 31, 2022, continues to expect revenue growth of 11% to 18% for 2022.

On a non-GAAP basis, net loss was $6.8 million or $0.13 per share in the first quarter of 2022, compared to net income of $7.2 million or $0.14 per share in the first quarter of 2021.

Revenue for the three months ended March 31, 2022 increased 18% to $79.4 million from $67.4 million in the first quarter of 2021.

Looking ahead to 2022, the company continues to expect revenues of between $330 million and $350 million. Revenue was $296.4 million in 2021.

Wall Street analysts on average expect the company to report revenue of $342.22 million for the year.

CDNA closed Thursday’s session at $31.66, down 7.07%.

7. Certara Inc. (CERT) delivered strong first quarter results, driven by continued strong demand for its technology-focused services and proprietary software.

Adjusted net income for the first quarter of 2022 increased to $16.9 million or $0.11 per share from $14.4 million or $0.09 per share for the first quarter of 2021. total for the first quarter of 2022 was $81.6 million, compared to $66.7 million for the year-quarter ago.

Looking ahead to 2022, the company continues to expect adjusted earnings of $0.48 to $0.53 per share on revenue of $350 million to $360 million. Adjusted earnings were $0.17 per share and revenue was $286.1 million in 2021.

Analysts on average expect the company to earn $0.44 per share on revenue of $355.92 million for 2022.

CERT closed Thursday’s session at $18.69, down 4.84%.

8. Gritstone bio Inc. (GRTS) has some data readings scheduled for the second half of this year.

The company is awaiting initial data from its ongoing phase II study of the “ready-to-use” neo-antigen immunotherapy SLATE-KRAS in patients with advanced non-small cell lung cancer and colorectal cancer in the second half of 2022.

Multiple Phase 1 trials of a next-generation COVID-19 vaccine program against SARS-CoV-2, known as CORAL, are underway, with data from all studies expected through the second half of the year. of this year.

GRTS closed Thursday’s session at $2.58, down 5.84%.

9. NGM Biopharmaceuticals Inc. (NGM) has a few clinical trial catalysts to watch for in the coming months.

The following data readings are scheduled for the second half of this year.

— The first data from a phase II trial of NGM621 in patients with geographic atrophy, called CATALINA, are expected in the second half of this year. — A phase I/II trial of NGM707 as monotherapy and in combination with Merck’s Keytruda in advanced or metastatic solid malignancies is underway. The first interim monotherapy data from this trial are expected in the second half of this year. — A Phase 1a/1b study of NGM120 as monotherapy in patients with certain advanced solid tumors (cohort 1) and in combination with gemcitabine and Abraxane in patients with metastatic pancreatic cancer is ongoing . Updated data from this trial are expected in the second half of this year.

A Phase IIb trial of Aldafermin in patients with compensated NASH cirrhosis, dubbed ALPINE 4, has completed enrollment and readout of primary data is expected in the first half of 2023.

NGM closed Thursday’s session at $11.96, down 0.66%.

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.

James T. Quintero