ABC Boosts EPS Outlook, ADPT Sees 20-26% Revenue Growth, ANAB To Report HARP Data In Q3

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

1. AmerisourceBergen Corporation (ABC) has boosted its earnings outlook for fiscal year 2022 to reflect stronger than expected performance of several of its businesses.

The company now expects adjusted EPS to be in the range of $10.80 to $11.05 for fiscal year 2022, up from its previous outlook range of $10.60 to $10.90 and above analysts’ consensus estimate of $10.79 per share.

Adjusted EPS was $3.22 in the second quarter ended March 31, 2022, on revenue of $57.7 billion. This compares with adjusted EPS of $2.53 and revenue of $49.15 billion in the year-ago quarter.

Analysts polled by Thomson Reuters were expecting the company to earn $2.93 per share on revenue of $57.27 billion for the quarter.

ABC closed Wednesday’s trading at $156.79, up 4.00%.

2. Acadia Pharmaceuticals Inc. (ACAD) has a regulatory catalyst to watch next month.

The company’s supplemental New Drug Application for Pimavanserin for the treatment of hallucinations and delusions associated with Alzheimer’s disease psychosis is under FDA review, with a decision expected on June 17, 2022.

The FDA had declined to approve Pimavanserin for expanded use in the above indication last April, citing “a lack of statistical significance in some of the subgroups of dementia, and insufficient numbers of patients with certain less common dementia subtypes as lack of substantial evidence of effectiveness to support approval”.

Pimavanserin is already approved in the U.S. under the brand name Nuplazid for the treatment of hallucinations and delusions associated with Parkinson’s disease.

Net sales of Nuplazid were $115.5 million for the three months ended March 31, 2022, compared to $106.6 million in the year-ago period.

Looking ahead to 2022, the company expects the drug to generate net sales of $510 to $560 million. Net sales of Nuplazid were $484.1 million in 2021.

ACAD closed Wednesday’s trading at $19.89, up 0.40%.

3. Adaptive Biotechnologies Corp. (ADPT), which reported better-than-expected first quarter results, continues to expect revenue for 2022 to grow in the range of nearly 20-26% year-over-year.

Looking ahead to 2022, the company has reiterated its revenue outlook in the range of $185 million to $195 million. Revenue reported in 2021 was $154.3 million.

Wall Street analysts’ consensus revenue estimate for the year is $189.38 million.

Net loss attributable to the company widened to $62.7 million or $0.44 per share for the first quarter of 2022 from $40.6 million or $0.29 per share for the same period in 2021. Revenue was $38.6 million for the first quarter of 2022, representing a 0.5% increase from the first quarter in the prior year.

Analysts polled by Thomson Reuters were expecting a loss of $0.45 per share on revenue of $37.71 million for Q1, 2022.

ADPT closed Wednesday’s trading at $9.25, up 3.35%.

4. Aligos Therapeutics Inc. (ALGS), a clinical-stage biopharmaceutical company developing novel therapeutics for viral and liver diseases, has a couple of events planned for the second half of this year.

— A phase I trial of ALG-000184 after single and multiple doses in healthy volunteers and chronic hepatitis B patients is underway. The company plans to share top line results for 28 day and 12-week cohorts of this trial in the second quarter and fourth quarter of 2022, respectively.
— A phase I proof of concept study of ALG-055009 in healthy volunteers and subjects with hyperlipidemia is ongoing, with topline results slated for release in the third quarter of 2022.

As of March 31, 2022, the company’s cash, cash equivalents and marketable securities totaled $183.2 million.

ALGS closed Wednesday’s trading at $1.24, down 0.80%.

5. AnaptysBio Inc. (ANAB) has a clinical trial catalyst to watch next quarter.

A phase II trial of lead drug candidate Imsidolimab in moderate-to-severe hidradenitis suppurativa, dubbed HARP, is underway. Topline data from this study is expected in the third quarter of 2022.

Imsidolimab is also under a phase III trial in generalized pustular psoriasis, dubbed GEMINI-1, with topline data anticipated in Q4 2023.

Rosnilimab and ANB032 are the other clinical drug candidates in the pipeline.

— Rosnilimab is under a phase II clinical trial in moderate-to-severe alopecia areata, known as AZURE, with top-line data expected in the first half of 2023.
— ANB032 is being developed for treatment of inflammatory diseases associated with lymphoid and myeloid immune cell dysregulation. This compound is expected to advance into phase II testing in the second half of this year.

ANAB closed Wednesday’s trading at $24.33, down 0.57%.

6. Apellis Pharmaceuticals Inc. (APLS) expects to submit the New Drug Application for intravitreal Pegcetacoplan in geographic atrophy secondary to age-related macular degeneration this quarter.

The company plans to seek approval for intravitreal Pegcetacoplan in Europe in the second half of 2022.

A phase II registrational study with systemic Pegcetacoplan for amyotrophic lateral sclerosis, dubbed MERIDIAN, is ongoing, with top-line results expected in mid-2023.

A phase III study of systemic Pegcetacoplan for Immune complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy is expected to be initiated in the second quarter of 2022.

APLS closed Wednesday’s trading at $45.95, up 3.00%.

7. BioAtla Inc. (BCAB) has two catalysts to watch in the coming months.

An interim update from a phase II trial of Mecbotamab Vedotin in AXL-positive Non-Small Cell Lung Carcinoma is anticipated on or around 2Q22 earnings call.

The company expects to provide an interim update from its phase II trial of Ozuriftamab Vedotin in patients with ROR2-positive NSCLC in the second half of 2022.

As of March 31, 2022, cash and cash equivalents were $219.4 million.

BCAB closed Wednesday’s trading at $4.08, up 6.53%.

8. Frequency Therapeutics Inc. (FREQ), a clinical-stage regenerative medicine, expects to achieve a few milestones in the coming months.

A phase IIb trial of FX-322 in individuals with acquired sensorineural hearing loss is underway, with data expected in Q4 2022 or Q1 2023.

The second investigational therapeutic candidate for sensorineural hearing loss is FX-345, which is currently under IND-enabling studies. An IND application for FX-345 is expected to be filed in the second half of 2022.

FREQ closed Wednesday’s trading at $1.30, up 4.00%.

9. PetIQ Inc. (PETQ), a pet medication and wellness company, has reported better-than-expected results for the first quarter of 2022, and has reiterated its revenue outlook for the year.

Adjusted net income for the first quarter of 2022 increased to $18.3 million or $0.62 per share on net sales of $275.7 million. This compares with adjusted net income of $11.0 million or $0.41 per share and net sales of $254.3 million in the year-earlier quarter.

Wall Street analysts were looking for earnings of $0.37 per share and sales of $269.34 million for the quarter.

For full-year 2022, the company continues to expect net sales of approximately $985 million representing an increase of 5.6% compared to 2021.

Analysts, on average, expect the company to report net sales of $985.77 million for the year.

PETQ closed Wednesday’s trading at $19.97, up 1.42%.

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