VNDA On Watch, NUVA Q2 Results Miss Estimates, MRTX Awaits FDA Decision…

The following are some of the healthcare companies that reported quarterly financial results and provided a pipeline update on Wednesday.

1. Vanda To Report Bipolar Disorder Trial Results By Year-end

Vanda Pharmaceuticals Inc. (VNDA), which reported a 5% decrease in total net product sales in the second quarter of 2022, has a couple of make-or-break events to watch in the coming months.

For the second quarter ended June 30, 2022, the total net product sales from HETLIOZ and Fanapt were $64.4 million compared to $67.9 million in the second quarter of 2021. Net income in Q2, 2022 declined to $2.6 million or $0.05 per share from $9.7 million or $0.17 per share in the year-ago period.

The trial for the consolidated lawsuit related to HETLIOZ patent against the companies seeking approval for generic versions of the sleep drug HETLIOZ was held in March of this year. A decision is expected from the court by the end of 2022.

While HETLIOZ net product sales declined 7% to $41.2 million in the second quarter of 2022, net product sales of Fanapt, an antipsychotic for the treatment of schizophrenia, were down 1% to $23.2 million.

Fanapt is also being explored in a phase III clinical study in acute manic episodes in patients with bipolar disorder. Results are expected by the end of 2022.

Another catalyst to watch for this year is the clinical data from a phase II trial of a single-dose treatment of VQW-765 to alleviate social/performance anxiety. Results are expected by the end of 2022.

Looking ahead to full-year 2022, the company expects total revenue to be in the range of $240 to $280 million. The analysts’ consensus revenue estimate is $265.1 million and full year 2021 total revenue was $268.7 million.

VNDA closed Wednesday’s trading at $10.80, up 3.55%.

2. Arcus Awaits ARC-7 Study Data

Arcus Biosciences Inc. (RCUS) expects to report topline data from its ARC-7 study in the second half of 2022.

ARC-7 is a phase II trial evaluating the safety and efficacy of Zimberelimab alone vs. Domvanalimab plus Zimberelimab vs. Domvanalimab plus Zimberelimab and Etrumadenant in first-line PD-L1=50% metastatic non-small cell lung cancer (NSCLC).

Gilead and Arcus are co-developing and equally share co-development costs for the three investigational molecules: Domvanalimab, Etrumadenant, and Zimberelimab.

The two companies also expect to initiate two phase II platform lung studies evaluating novel Domvanalimab-based combinations, including Domvanalimab plus Zimberelimab-based triplet combinations with Etrumadenant, Trodelvy, and/or Quemliclustat, by year-end.

Arcus is gearing up to initiate ARC-20, a phase 1/1b study to evaluate AB521 in cancer patients this quarter.

RCUS closed Wednesday’s trading at $26.35, up 3.99%.

3. Personalis’ FY22 Revenue To Decline 21-27%

Personalis Inc. (PSNL), which reported better-than-expected results for the second quarter of 2022, expects revenue for the year to decline 21-27%.

Net loss for the second quarter of 2022 widened to $27.5 million or $0.60 per share from $14.9 million or $0.34 per share in the year-ago period. Revenue for Q2, 2022 dropped to $18.2 million from $21.7 million in Q2, 2021.

However, the company’s Q2 numbers trumped analysts’ consensus estimate of a loss of $0.63 per share and revenue of $15.5 million.

Looking ahead to full-year 2022, the company expects revenue to be in the range of $62.0 million to $67.0 million and net loss to be in the range of $110.0 million to $115.0 million.

Revenue was $85.5 million and net loss was $65.2 million in full-year 2021.

PSNL closed Wednesday’s trading at $4.48, up 10.07%.

4. Paratek’s Lead Commercial Product Records 68% Jump In Net Sales

Paratek Pharmaceuticals Inc. (PRTK) has reported a 68% increase in net sales of its lead commercial product, NUZYRA, in the second quarter of 2022.

Total revenue for the second quarter of 2022 jumped to $29.6 million from $19.6 million in the year-ago quarter. The Q2, 2022 total revenue included $25.1 million in U.S. net sales of NUZYRA, $4.0 million in revenue earned under the BARDA contract, and $0.6 million in royalty revenue.

The company incurred a net loss of $17.6 million or $0.33 per share in the second quarter of 2022, in contrast to a net income of $9.7 million or $0.20 per share in the year-ago quarter.

Commenting on the results, Evan Loh, chief executive officer at Paratek, said, “We expect demand trends for NUZYRA will continue through the end of the year. We are pleased with the improved access to physicians and the breadth of NUZYRA’s commercial and government payer access, resulting in strong performance in both the hospital and community setting”.

NUZYRA is an antibiotic indicated for the treatment of community-acquired bacterial pneumonia and acute bacterial skin and skin structure infections.

PRTK closed Wednesday’s trading at $2.52, up 3.70%.

5. Pacific Biosciences Guides FY22 Revenue below Estimates

Pacific Biosciences of California, Inc. (PACB) has reported a 16% revenue growth in the second quarter of 2022 and has guided full year revenue well below analysts’ estimate.

The company markets Sequel II and IIe systems that provide scientists with access to high throughput, cost effective, highly accurate long-read sequencing.

The company delivered 36 Sequel II/IIe systems in Q2, 2022 compared with 38 Sequel II/IIe systems in the prior year period.

Revenue for Q2, 2022 increased 16% to $35.5 million from $30.6 million in the prior year period.

On a non GAAP basis, net loss per share for the second quarter of 2022 widened to $76.6 million or $0.34 per share from $41.0 million or $0.21 per share for the second quarter of 2021.

Wall Street analysts were expecting a loss of $0.32 per share on revenue of $35.16 million.

Operating expenses totaled $84.2 million for the second quarter of 2022, up from $51.3 million in the year-ago period.

Looking ahead to full year 2022, the company expects revenue to be in the range of $138 million to $145 million, well below the analysts’ consensus estimate of $161.95 million. Revenue was $130.5 million in full-year 2021.

PACB closed Wednesday’s trading at $5.21, up 7.42%.

6. NuVasive Q2 Results Miss Estimates

NuVasive Inc. (NUVA), a company focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, has reported lower-than-expected earnings and sales for the second quarter of 2022.

On a non-GAAP basis, the net income declined to $24.8 million or $0.47 per share from $31.2 million or $0.60 per share in the prior year period and came in below analysts’ consensus estimate of $0.56 per share

The total net sales for Q2, 2022 rose to $310.5 million from $294.8 million in the prior year period, beating analysts’ consensus estimate of $306.43 million. The company attributes the commercial launches of the Simplify Cervical Disc and the Pulse platform, as well as higher procedure volume in the U.S. and strong international performance for the sales growth.

Looking ahead to full-year 2022, the company continues to expect net sales growth of 6.0%-8.0% and non GAAP EPS range of $2.15 to $2.45. Net sales were $1.139 billion and non GAAP EPS was $1.68 in 2021.

NUVA closed Wednesday’s trading at $53.17, up 0.04%.

7. Inari Medical Expects FY22 Revenue To Grow 30-34%

Inari Medical Inc. (NARI), a medical device company, has reaffirmed revenue growth of nearly 30% to 34% for full-year 2022.

The company continues to expect revenue in the range of $360 million to $370 million for this year. The consensus estimate of analysts polled by Thomson Reuters is $364.53 million for the year. Revenue was $277.0 million in 2021.

NARI closed Wednesday’s trading at $81.68, up 0.93%.

8. Mirati Therapeutics Inching Closer To FDA Decision Date

Mirati Therapeutics Inc. (MRTX) has a regulatory catalyst to watch this year related to its lead drug candidate Adagrasib.

Adagrasib, proposed for the treatment of patients with non-small cell lung cancer harboring the KRASG12C mutation who have received at least one prior systemic therapy, is under FDA review, with a decision expected on Dec.14, 2022.

The company has also sought European Medicines Agency approval for Adagrasib for the above indication.

Next in the pipeline is Sitravatinib, which is under a global, registrational phase III study, being studied in combination with OPDIVO, in second or third line non-squamous NSCLC, dubbed SAPPHIRE. The study is expected to achieve the number of events needed to trigger an interim analysis of overall survival in the fourth quarter of this year.

MRTX closed Wednesday’s trading at $71.78, up 2.47%.

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