ATRC Sees 16-20% Revenue Growth, RIGL On Watch, LUNG Breathes Easy, BPMC Braces For Busy Year

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

1. Acadia Healthcare Co. Inc. (ACHC), a provider of behavioral healthcare services, reported strong earnings for the first quarter ended March 31, 2022.

Adjusted income from continuing operations attributable to the company jumped to $61.2 million or $0.67 per share from $42.2 million or $0.47 per share in the year-ago quarter. Revenue was $616.7 million for the first quarter of 2022, compared with $551.2 million for the first quarter of 2021.

Wall Street analysts were expecting $0.64 per share on revenue of $606.48 million for the quarter.

Looking ahead to 2022, the company continues to expect adjusted earnings per share of $2.85 to $3.15 and revenue in the range of $2.55 billion to $2.60 billion. Analysts polled by Thomson Reuters expect the company to report earnings of $2.97 per share and revenue of $2.58 billion for the year.

ACHC closed Tuesday’s trading at $67.44, up 0.85%.

2. Aquestive Therapeutics Inc. (AQST) expects to report topline results from Part 3 of EPIPHAST study in June.

EPIPHAST is a three-part adaptive design, crossover study in healthy adult subjects comparing the pharmacokinetics and pharmacodynamics of epinephrine delivered via Aquestive’s AQST-109 oral film compared to intramuscular injection of epinephrine.

Data from Part 2 and Part 3, reported earlier, have demonstrated that AQST-109 was well tolerated with no serious adverse events. In addition to positive pharmacokinetic results, AQST-109 has demonstrated favorable pharmacodynamic effects on systolic blood pressure, diastolic blood pressure, and heart rate in Part 2 of the EPIPHAST study.

The purpose of Part 3 is to continue to study the administration of AQST-109 oral film under a variety of conditions and further characterize its pharmacokinetics, pharmacodynamics, and safety.

AQST-109 is being developed for the treatment of anaphylaxis.

The company plans to meet with the FDA for an End-of-Phase 2 meeting in the second half of 2022, and to start the pivotal study before the end of the year.

AQST closed Tuesday’s trading at $1.37, down 2.84%.

3. AtriCure Inc. (ATRC) expects 2022 revenue to grow 16% to 20% year-over-year.

Net loss for the first quarter of 2022 narrowed to $15.2 million or $0.33 per share on revenue of $74.6 million. This compared with a net loss of $16.92 million or $0.38 per share and revenue of $59.3 million in the year-earlier quarter.

Wall Street analysts were expecting a loss of $0.32 per share on revenue of $71.17 million for the first quarter of 2022.

For full year 2022, the company expects adjusted loss per share of approximately $1.07 to $1.12 and revenue range of $318 million to $330 million. The adjusted loss per share was $1.16 and revenue was $274.3 million in 2021.

Analysts polled by Thomson Reuters are expecting a loss of $1.05 per share and revenue of $321.65 million for 2022.

ATRC closed Tuesday’s trading at $54.63, down 0.22%.

4. Blueprint Medicines Corp. (BPMC) is planning to achieve a couple of near-term milestones in the coming months.

— A supplemental new drug application seeking approval of AYVAKIT in the expanded use in non-advanced systemic mastocytosis is expected to be submitted to the FDA in the second half of 2022.

AYVAKIT is already approved for the treatment of PDGFRa exon 18 mutant gastrointestinal stromal tumors and advanced systemic mastocytosis. The drug generated global net product revenues of $23.8 million for the first quarter of 2022 compared to $7.1 million in the year-earlier period.

— Initial data from its phase I/II trial of BLU-701 as monotherapy or in combination with either Osimertinib or platinum-based chemotherapy in patients with EGFRm NSCLC, dubbed HARMONY, is expected to be presented in the second half of 2022.

— Initial data from Part 1 of HARBOR trial of BLU-263 in non-advanced systemic mastocytosis in the second half of 2022. HARBOR is a phase II/III study comparing the efficacy and safety of BLU-263 + best supportive care (BSC) with placebo + BSC in patients with indolent systemic mastocytosis (ISM) whose symptoms are not adequately controlled by BSC.

BPMC closed Tuesday’s trading at $62.82, up 5.19%.

5. DermTech Inc. (DMTK) continues to expect assay revenue growth of 100% to 136% year-over-year in 2022.

Assay revenue for full-year 2022 is expected to be between $22 million and $26 million compared to $11.0 million in 2021. Analysts’ consensus revenue estimate for the year is $24.18 million.

DMTK closed Tuesday’s trading at $9.47, down 0.21%.

6. Infinity Pharmaceuticals Inc. (INFI) expects to initiate a couple of clinical trials and present data in the coming months.

— An update on MARIO-3, the company’s ongoing phase II study evaluating lead drug candidate Eganelisib in combination with Tecentriq and Abraxane in frontline metastatic triple negative breast cancer is expected to be provided in the second half of this year.

According to the results reported last December, tumor reduction was achieved in 88.6% of evaluable patients and it was associated with a disease control rate of 81.4% in patients with PD-L1 negative tumors.

— An update on MARIO-275, a phase II study evaluating the efficacy and safety of Eganelisib in combination with Opdivo in platinum-refractory, I/O naïve patients with advanced Urothelial Cancer is expected in the second half of this year.

— Data from MARIO-3 study in renal cell carcinoma patients is expected in the second half of this year. MARIO-3 is a phase II multi-arm combination cohort study designed to evaluate IPI-549 in combinations with Tecentriq and Abraxane in front-line triple negative breast cancer and in combination with Tecentriq and Avastin in front-line renal cell cancer.

— The company expects to initiate MARIO-4, a randomized, double-blind, registrational trial of Eganelisib in front-line metastatic triple negative breast cancer, by year-end 2022.

— MARIO-P, a clinical program designed to rapidly evaluate the clinical benefit of Eganelisib in combination regimens in additional solid tumor indications is expected to be initiated, on a rolling basis starting in 3Q 2022.

The company ended March 31, 2022, with total cash, cash equivalents and available-for-sale securities of $67.1 million.

INFI closed Tuesday’s trading at $0.84, up 6.99%.

7. Kiniksa Pharmaceuticals Ltd. (KNSA) anticipates continued robust commercial execution and the further advancement of its clinical-stage pipeline in 2022.

The company markets Arcalyst injection to treat recurrent pericarditis and reduce the risk of recurrence in adults and children 12 years and older. The drug has been commercially available in the U.S. since April 1, 2021.

Arcalyst net revenue for the full-year 2022 is expected to be between $115 million and $130 million. The drug generated net revenue of $38.5 million in 2021.

A phase 2b dose-ranging clinical trial of once-monthly subcutaneous Vixarelimab in prurigo nodularis is underway, with data anticipated in the second half of 2022.

The company ended March 31, 2022, with zero debt and cash, cash equivalents and short-term investments of $145.6 million.

KNSA closed Tuesday’s trading at $10.11, up 7.44%.

8. Kymera Therapeutics Inc. (KYMR), a clinical-stage biopharmaceutical company developing targeted protein degradation to deliver novel small molecule protein degrader medicines, looks ahead to sharing data from its two oncology programs, KT-413 and KT-333, in the second half of this year.

— KT-413 is under a phase I trial in adult patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma.
— KT-333 in under a phase I study in adult Patients with refractory lymphoma, large granular lymphocytic leukemia, solid tumors.

The company expects to file an investigational new drug application for KT-253 in the second half of this year. KT-253 is being developed as a potential treatment for a wide range of hematological malignancies and solid tumors with functioning (WT) p53.

The company’s cash on hand totaled $523.3 million as of March 31, 2022.

KYMR closed Tuesday’s trading at $24.88, down 23.98%.

9. Pulmonx Corp. (LUNG), which reported 17% revenue growth for its first quarter of 2022, expects revenue for 2022 to increase nearly 14% – 24% year-over-year.

The company markets Zephyr Valve, a viable, a minimally-invasive treatment option for severe emphysema, in more than 25 countries.

For the full year 2022, the company expects revenue to be in the range of $55 million to $60 million. Revenue was $48.4 million in full-year 2021.

Analysts, on average, expect the company to report revenue of $57.84 million for this year.

As of March 31, 2022, the company had cash, cash equivalents, and marketable securities of $176.5 million.

LUNG closed Tuesday’s trading at $25.34, up 1.04%.

10. Rigel Pharmaceuticals Inc. (RIGL) has a make-or-break event to watch in the coming months.

The company expects to report data from a pivotal phase III clinical trial of Fostamatinib, an oral SYK inhibitor, in patients with warm autoimmune hemolytic anemia (wAIHA) in mid-2022.

Last month, Rigel’s partner Kissei Pharmaceutical Co. Ltd. submitted a new drug application to Japan’s Pharmaceuticals and Medical Devices Agency for Fostamatinib in chronic immune thrombocytopenia (ITP). Fostamatinib is commercially available in the United States under the brand name TAVALISSE for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment.

In the first quarter of 2022, TAVALISSE net product sales were $16.2 million compared to $12.4 million in the first quarter of 2021.

RIGL closed Tuesday’s trading at $2.48, up 0.81%.

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