Alnylam Q2 Loss Widens, SGEN Boosts Revenue Outlook, NVCR To Report LUNAR Study Data In Q1

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

1. ALNY Q2 Loss Widens, Revenue Miss Estimates

Alnylam Pharmaceuticals Inc. (ALNY), which reported lower-than-expected results for the second quarter, has reiterated its outlook for the year.

The company has 3 marketed drugs – Onpattro, Givlaari, and Oxlumo – and a robust pipeline of investigational RNAi therapeutics.

On a non GAAP basis, net loss for the second quarter ended June 30, 2022, widened to $245.8 million or $2.03 per share from $153 million or $1.30 per share in the year-ago period. Wall Street analysts expected the company to incur a loss of only $1.63 per share for Q2, 2022.

The total revenue, including net product revenue, net revenues from collaborations and royalty revenue improved to $224.8 million in Q2, 2022 from $220.5 million in the year-ago quarter, but fell shy of the analysts’ consensus estimate of $255.88 million.

The product revenue from the company’s 3 marketed drugs accounted for $213.5 million in the second quarter of 2022, up from $160.8 million in the year-ago period.

The company’s top-selling drug Onpattro accounted for product revenue of $153 million in Q2, 2022, an increase of 35%, followed by Givlaari’s $45 million, which registered a growth of 47%. Oxlumo contributed $14.9 million to the product revenue in Q2, 2022, a decline of 9% over the year-ago quarter.

For full year 2022 the company continues to expect combined net product revenues to range between $870 million and $930 million.

Near-term Catalyst:

A pivotal phase III trial of Patisiran in ATTR amyloidosis patients with cardiomyopathy, dubbed APOLLO-B, is underway, with topline results expected to be available within the next three weeks.

Some anticipated events in mid- and late-2022

— Plans for phase III clinical development of Cemdisiran in patients with immunoglobulin A nephropathy are expected to be finalized, with the potential to initiate a program by late 2022.
— Report topline results from Part B of a phase I study of ALN-HSD in patients with NASH.
— Launch Vutrisiran in the EU, assuming a favorable adoption of the CHMP opinion by the European Commission, for the treatment of hATTR amyloidosis patients with polyneuropathy. Vutrisiran was approved in the U.S as recently as June 13, 2022, for the treatment of the polyneuropathy of hereditary transthyretin-mediated (hATTR) amyloidosis in adults.
— Initiate a phase III study of Vutrisiran in patients with Stargardt Disease.
— Report preliminary results from a phase I study of ALN-APP in patients with early-onset Alzheimer’s disease.
— Report preliminary results from a phase I study of ALN-XDH in patients with gout.

ALNY closed Thursday’s trading at $143.52, up 1.09%.

2. Argenx braces for a busy year

argenx SE (ARGX) has a couple of regulatory and clinical trial events lined up for the coming months.

The European Commission is expected to announce its decision on VYVGART, intended for the treatment of anti-acetylcholine receptor antibody positive generalised Myasthenia Gravis, this quarter. The drug was recently approved in the U.S. and Japan, and it generated global net product revenues of $75 million for second quarter of 2022.

The company expects to start a registrational trial of SC Efgartigimod, dubbed ALKIVIA, for three subtypes of idiopathic inflammatory myopathies, including immune-mediated necrotizing myopathy, anti-synthetase syndrome and dermatomyositis, this quarter.

The Biologics License Application for SC Efgartigimod for generalized myasthenia gravis is on track to be filed by end of 2022.

Topline data from a registrational trial of SC Efgartigimod for chronic inflammatory demyelinating polyneuropathy, dubbed ADHERE, is expected in first quarter of 2023.

Topline data from a second registrational trial of SC Efgartigimod for primary immune thrombocytopenia, dubbed ADVANCE-SC, are expected in second half of 2023.

Topline data from a registrational trial of SC Efgartigimod for pemphigus vulgaris and foliaceus, dubbed ADDRESS, are also expected in second half of 2023.

ARGX closed Thursday’s trading at $372.97, up 4.22%.

3. CVRx Expects FY22 Revenue to Grow 6-8%

CVRx Inc. (CVRX), a commercial-stage medical device company, has revised its business outlook for full-year 2022 and has provided third-quarter revenue outlook.

Looking ahead to full year 2022, the company now expects total revenue to range between $20.5 million and $23.0 million compared to prior guidance of $20.0 million and $23.0 million. Total revenue was $13.0 million for the full year ended December 31, 2021.

Wall Street analysts have pegged the consensus revenue estimate at $21.27 million for the year.

Gross margin is now anticipated to be between 75% and 76%, up from prior guidance of 74% and 76%.

For the third quarter of 2022, the company expects to report total revenue between $5.5 million and $6.0 million while the analysts’ consensus estimate is $5.53 million. Total revenue for the third quarter 2021 was $3.4 million.

CVRX closed Thursday’s trading at $7.55, up 4.43%.

4. Ekso Bionics Q2 Revenue Jumps 53%

Ekso Bionics Holdings Inc. (EKSO) reported a wider loss for the second ended June 30, 2022, even as revenue jumped 57% year-over-year.

Net loss applicable to common stockholders for the second quarter of 2022 widened to $3.0 million or $0.23 per share from $1.3 million or $0.11 per share for the same period in 2021.

The company operates in two segments – EksoHealth and EksoWorks.

Revenue was $3.5 million for the second quarter of 2022 compared to $2.2 million for the same period in 2021. EksoHealth segment accounted for revenue of $3.2 million while EksoWorks contributed $0.2 million to total revenue in Q2, 2022.

Last month, the company received FDA clearance to market its EksoNR robotic exoskeleton for use with Multiple Sclerosis patients.

EKSO closed Thursday’s trading at $1.73, up 1.17%.

5. LeMaitre Guides Q3, FY22 EPS Below Estimates

LeMaitre (LMAT), a provider of vascular devices, implants and services, has forecast earnings for the third quarter and full-year 2022, well below the analysts’ consensus estimate.

LeMaitre has forecast earnings per share of $0.24 to $0.29 for Q3, below the analysts’ consensus estimate of $0.31. For the third quarter of 2022, the company expects sales in the range of $39.0 million to $41.0 million while the analysts’ consensus estimate is $40.12 million.

The company had reported earnings of $0.30 per share and revenue of $38.4 million in Q3, 2021.

Looking ahead to full-year 2022, LeMaitre anticipates EPS in the range of $0.99 to $1.05 and sales in the range of $162.7 million to $165.3 million. Analysts polled by Thomson Reuters are expecting earnings of $1.18 per share and revenue of $162.6 million.

The company had reported sales of $154 million and earnings of $1.25 per share for full-year 2021.

LMAT closed Thursday’s trading at $48.83, up 1.54%.

6. Novocure To Report LUNAR Study Data In Q1

Novocure (NVCR) expects to reach a number of clinical and product development milestones in the next 18 months.

— Data from phase 2 pilot EF-33 study with high-intensity arrays in recurrent GBM in 2022.
— Data from phase 3 pivotal LUNAR study in NSCLC in early Q1 2023.
— Data from phase 3 pivotal INNOVATE-3 study in recurrent ovarian cancer in 2023.
— Data from phase 3 pivotal METIS study in brain metastases in 2023.
— Data from phase 3 pivotal PANOVA-3 study in locally advanced pancreatic cancer in 2024.

NVCR closed Thursday’s trading at $70.24, down 5.03%.

7. Seagen Boosts FY22 Revenue Outlook

Seagen Inc. (SGEN) has boosted its full-year 2022 revenue outlook on the back of increased net sales expectations for its drug Adcetris, as well as higher collaboration and license agreement revenues.

The company now expects total revenue for full year 2022 to range between $1,710 million and $1,795 million, up from its earlier forecast range of $1,665 million to $1,745 million. Total revenue in full-year 2021 was $1,574 million.

Wall Street analysts have pegged the consensus revenue estimate at $1.79 billion for the year.

SGEN closed Thursday’s trading at $177.43, up 0.36%.

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