The following are some of the healthcare companies that reported their quarterly financial results and provided a pipeline update yesterday.
1. Aquestive Therapeutics Awaits EPIPHAST II Study Data In Q3
Aquestive Therapeutics Inc. (AQST) has revised its revenue outlook for full-year 2022 on the strength of the already implemented expense reductions, continued growth of its commercial proprietary product Sympazan, and the performance of its manufacturing and supply operations, among other things.
For full-year 2022, the company now expects total revenue to be in the range of $46 million to $49 million, up from its prior outlook range of $42 million to $47 million. Total revenue was $50.8 million for the full year 2021.
A study comparing AQST-109 to epinephrine 0.3mg intramuscular (IM) injection (repeat dose) and AQST-109 to EpiPen 0.3mg (single dose), dubbed EPIPHAST II, is underway, with data expected during this quarter.
AQST-109 is being developed for the treatment of anaphylaxis.
AQST closed Tuesday’s trading at $0.87, up 2.64%.
2. AtriCure Expects 18-21% Revenue Growth In 2022
AtriCure Inc. (ATRC), which reported better-than-expected revenue for the second quarter of 2022, has projected approximately 18% to 21% revenue growth for this year.
Revenue for the second quarter 2022 rose 18.4% to $84.5 million from $71.4 million in the year-ago quarter, which came in above analysts’ estimate of $79.67 million.
On a non GAAP basis, adjusted net loss widened to $14.8 million or $0.32 per share in the second quarter of 2022 from $13.7 million or $0.30 per share in the year-earlier quarter. Wall Street analysts were expecting a loss of only $0.29 per share.
Looking ahead to full year 2022, the company expects adjusted loss per share of approximately $1.07 to $1.12 and revenue to be approximately $323 million to $333 million. The adjusted loss per share was $1.16 and revenue was $274.3 million in 2021.
Analysts expect the company to incur a loss of $1.10 per share on revenue of $324.43 million for this year.
ATRC closed Tuesday’s trading at $49.69, up 1.72%.
3. Blueprint Medicines’ Lead Drug Sales To More Than Double In FY22
Blueprint Medicines Corp. (BPMC) has a couple of clinical trial catalysts to watch in the coming months.
The company is planning to report topline data for registration-enabling PIONEER trial of AYVAKIT in non-advanced systemic mastocytosis this month.
AYVAKIT is already approved by the FDA for the treatment of PDGFRa exon 18 mutant gastrointestinal stromal tumors and advanced systemic mastocytosis. The drug generated global net product revenues of $28.5 million for the second quarter of 2022 compared to $8.5 million in the year-ago quarter.
Looking ahead to full year 2022, the company expects AYVAKIT to bring in net product revenue of $115 million to $130 million compared to $53.0 million reported in 2021.
The other clinical trial events lined up are:
— Initial dose escalation data from a Phase 1/2 SYMPHONY trial of BLU-945 in combination with osimertinib in EGFR-mutant NSCLC, dubbed SYMPHONY, is expected in the second half of 2022.
— Initial clinical data from a Phase 1/2 trial of BLU-701 in EGFR-mutant NSCLC, dubbed HARMONY, is anticipated in the second half of 2022.
— Initial data from phase II/III trial of BLU-263 in non-advanced Systemic Mastocytosis, dubbed HARBOR trial, is expected in the second half of 2022.
— Initial clinical data from phase I /II trial of BLU-451 in EGFR-mutant NSCLC, dubbed CONCERTO, is expected in the first half of 2023.
— Initial clinical data from phase I/II trial of BLU-222 in CDK2-vulnerable cancers, dubbed VELA, is expected in the first half of 2023.
BPMC closed Tuesday’s trading at $56.29, up 11.25%.
4. Evolent Q2 Results Trump Estimates
Evolent Health Inc. (EVH), which reported better-than-expected results for the second quarter ended June 30, 2022, has provided a rosy outlook for the third quarter and full year.
On an adjusted basis, income attributable to common shareholders was $9.4 million or $0.10 per share compared to a loss of $1.9 million or $0.02 per share in the year-ago quarter.
The total revenue soared to $319.9 million in the second quarter of 2022 from $222 million in the second quarter of 2021.
Wall Street analysts were looking for earnings of $0.05 per share on revenue of $297.84 million for Q2, 2022.
For the third quarter of 2022, the company has forecast revenue to be in the range of approximately $343.0 million to $363.0 million – well above the analysts’ consensus estimate of $312.69 million. Revenue was $222.5 million in the third quarter of 2021.
Looking ahead to full-year 2022, Evolent anticipates revenue to be in the range of approximately $1.32 billion to $1.36 billion, beating analysts’ estimate of $1.22 billion. Revenue was $907.9 million in 2021.
EVH closed Tuesday’s trading at $35.21, up 1.21%.
5. Exact Sciences Lowers FY22 Revenue Outlook
Exact Sciences Corp. (EXAS), which reported 20% revenue growth for the second quarter ended June 30, 2022, has trimmed its revenue forecast for the year.
Total revenue was $522 million in the second quarter of 2022 compared to $434.8 million in the year-ago period.
Net loss in Q2, 2022 narrowed to $166 million or $0.94 per share from $176.9 million or $1.03 per share in Q2, 2021.
Looking ahead to full year 2022, the company has lowered its revenue forecast range to $1,980 million to $2,022 million from its prior forecast range of $1,985 million to $2,032 million. The analysts’ consensus revenue estimate is pegged at $2.02 billion for the year. Revenue was $1,767 million in 2021.
EXAS closed Tuesday’s trading at $47.93, up 1.53%.
6. Harmony To Report Prader-Willi Syndrome Phase 2 Study Data In Q4
Harmony Biosciences Holdings Inc. (HRMY) has a clinical trial to watch in the fourth quarter of this year.
A phase II trial evaluating the company’s lead drug Wakix for the treatment of excessive daytime sleepiness and other key symptoms in patients with Prader-Willi Syndrome has completed enrollment, and topline data is expected next quarter.
Prader-Willi Syndrome (PWS) is a rare, genetic multi-system disease characterized by hypothalamic dysfunction. About 15,000-20,000 patients in U.S. have PWS and more than 50% of them have Excessive Daytime Sleepiness (EDS) due to sleep-wake state instability of central origin and other factors. There are no approved treatments for EDS in patients with PWS.
Enrollment is ongoing in a phase II clinical trial of Wakix for excessive daytime sleepiness (EDS) and other non-muscular symptoms in adult patients with type 1 myotonic dystrophy, with topline data expected in 2023.
Myotonic dystrophy is a rare, neurological and multi-system disease and is the most common form of adult-onset muscular dystrophy. Type 1 myotonic dystrophy (DMI) is the most common form of the disorder. It is estimated that there are 40,000 people currently diagnosed with DM1 in the U.S., with up to 90% of them reporting EDS and fatigue and over 60% of them experiencing cognitive dysfunction.
The net revenue generated from sales of Wakix soared to $107.0 Million in the second quarter of 2022, up from $73.8 million in the second quarter of 2021.
The company markets Wakix for the treatment of excessive daytime sleepiness in adults with narcolepsy. Known generically as Pitolisant, Wakix is the first and only FDA approved non-scheduled treatment option for narcolepsy.
HRMY closed Tuesday’s trading at $55.42, up 12.57%.
7. Pulmonx Projects 14-24% Revenue Growth For FY22
Pulmonx Corp. (LUNG), which reported 14% revenue growth for its second quarter of 2022, continues to expect revenue for the year to increase nearly 14%-24%.
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 continues to expect 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 $58.53 million for this year.
Total worldwide revenue in the second quarter of 2022 rose 14% to $14.0 million from $12.2 million in the second quarter of 2021. Net loss in Q2, 2022, widened to $14.6 million or $0.40 per share from $13.0 million or $0.36 per share for the same period in 2021.
LUNG closed Tuesday’s trading at $18.48, up 5.60%.
8. Lexicon to Report RELIEF-PHN-1 Trial Data In Q4
Lexicon Pharmaceuticals Inc. (LXRX) has a near-term catalyst to watch related to one of its drug candidates LX9211.
A phase II proof-of-concept study of LX9211 for the treatment of post-herpetic neuralgia, dubbed RELIEF-PHN-1, is underway, from which top-line results are expected next quarter (4Q).
LX9211 has been successfully studied in a phase II proof-of-concept study for the treatment of painful diabetic neuropathy, dubbed RELIEF-DPN-1.
The company’s lead drug candidate Sotagliflozin, proposed for the treatment of heart failure, is under FDA review, with a decision anticipated in May 2023.
LXRX closed Tuesday’s trading at $2.60, up 9.70%.
9. Rigel To Report COVID-19 Trial Data In Q4
Rigel Pharmaceuticals Inc. (RIGL) expects to report top-line results from a pivotal phase III clinical trial evaluating Fostamatinib in high-risk patients hospitalized with COVID-19 in the fourth quarter of this year.
Fostamatinib was approved for the treatment of patients with chronic immune thrombocytopenia in April 2018 and is marketed under brand name Tavalisse.
In the second quarter of 2022, Tavalisse net product sales were $18.6 million, representing the highest net product sales since launch and an increase of 9% compared to the second quarter of 2021.
RIGL closed Tuesday’s trading at $1.30, up 7.44%.
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