AERI Sees 16-25% Product Revenue Growth, NGM To Report NASH Trial Data In 1H23, CCXI On Watch

The following are some of the biotech companies that reported quarterly results and provided an update on their pipeline progress on Thursday.

1. Aerie Pharmaceuticals Inc. (AERI) expects to initiate a phase III registrational study for AR-15512 in dry eye during 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 quarter ended March 31, 2022, the company’s total glaucoma franchise net product revenues were $29.8 million, up 30% compared to $23.0 million in the year-earlier quarter.

Looking ahead to full-year 2022, the glaucoma franchise net product revenues are expected to be in the range of $130 million to $140 million, implying a growth of 16% to 25% over 2021.

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

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

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

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

Analysts’ consensus revenue estimate is $646.96 million for the second quarter and $2.59 billion for full-year 2022.

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

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

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

Adjusted net loss attributable to common stockholders was $16.4 million or $0.44 per share compared to a loss of $8.08 million or $3.54 per share in the year-earlier quarter.

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

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

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

Earlier, the company had forecast overall revenue for fiscal year 2022 to be up low to mid-single digit percent compared with 2021. Revenue for fiscal 2021 was $147.8 million.

Adjusted net loss for Q1, 2022 was $1.6 million or $0.11 per share, compared to adjusted net income of $0.8 million or $0.06 per share, in the prior year quarter.
Revenue in the first quarter of 2022 rose 7% to $36.7 million from $34.3 million in the first quarter of 2021.

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

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

In the U.S., TAVNEOS received approval last October as an adjunctive treatment of 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 Q4, 2021.

ChemoCentryx expects to initiate a clinical trial with TAVNEOS in Lupus nephritis during the second half of 2022, pending feedback from the FDA in mid-year 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 to take place late in the second quarter.

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

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

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

6. CareDx Inc. (CDNA), which reported 18% revenue growth 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 a 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 full-year 2022, the company continues to expect revenue in the range of $330 million to $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 trading at $31.66, down 7.07%.

7. Certara Inc. (CERT) delivered solid first quarter results, thanks to continued strong demand for its technology-driven 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 revenue for the first quarter of 2022 was $81.6 million, up from $66.7 million in the year-ago quarter.

Looking ahead to full-year 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 trading at $18.69, down 4.84%.

8. Gritstone bio Inc. (GRTS) has a couple of data readouts lined up for the second half of this year.

The company expects initial data from its ongoing phase II study of “off the-shelf” neoantigen 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 throughout the second half of this year.

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

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

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

— Topline data from a phase II trial of NGM621 in patients with geographic atrophy, dubbed CATALINA is 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 tumor malignancies is underway. Initial interim monotherapy data from this trial is expected the second half of this year.
— A phase 1a/1b study of NGM120 as a monotherapy in patients with select 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 is anticipated in the second half of this year.

A phase IIb trial of Aldafermin in patients with compensated NASH cirrhosis, dubbed ALPINE 4, has completed enrolment, and topline data readout is anticipated in the first half of 2023.

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

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