Atea Pharmaceuticals Inc Reports Results For The Quarter Ended September 30 - Earnings Summary

Beam Therapeutics Inc. BEAM incurred a loss of $1.17 per share in the third quarter of 2024, wider than the Zacks Consensus Estimate of a loss of $1.13. The company had recorded a loss of $1.22 per share in the year-ago quarter.

Total revenues, comprising license and collaboration revenues, came in at $14.3 million in the third quarter compared with $17.2 million reported in the year-ago period. The top line missed the Zacks Consensus Estimate of $15 million.

Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.

More on BEAM's Q3 Results

Research and development expenses were $94.3 million in the third quarter, down almost 5.8% from the year-ago quarter’s level.

General and administrative expenses totaled $26.5 million, increasing around 4.3% year over year.

As of Sept 30, 2024, BEAM had cash, cash equivalents and marketable securities worth $925.8 million compared with $1.2 billion as of June 30, 2024. The company expects that its existing cash balance is likely to fund its operating expenses into 2027.

Year to date, shares of Beam Therapeutics have declined 12% compared with the industry’s decrease of 3.8%.

BEAM's Pipeline Updates

The company is developing its leading ex-vivo genome-editing candidate, BEAM-101, in the phase I/II BEACON study for the treatment of adult patients with sickle cell disease (SCD).

To date, more than 35 patients have been enrolled in the BEACON study investigating BEAM-101 for the treatment of SCD. Of these, eight patients have been dosed with BEAM-101 in the study.

On the third-quarter conference call, management stated that the initial data from the BEACON study supported the potential for meaningful clinical differentiation of BEAM-101 as compared to currently available treatments for SCD.

Per the company, preliminary data as of July 2, 2024, suggested that the initial safety profile of BEAM-101 was consistent with busulfan conditioning and autologous hematopoietic stem cell transplantation.

However, one patient died four months after being treated with BEAM-101 due to respiratory failure. The FDA and the Data Safety Monitoring Committee reviewed the case. The patient's death was likely related to busulfan conditioning and was deemed not related to BEAM-101.

This might have impressed investors and resulted in the stock to rise in pre-market trading on Nov. 6.

Detailed data from the study is expected to be presented at a scientific conference later in 2024.

BEAM is also expanding its genetic disease pipeline by developing BEAM-301 and BEAM-302.

The company has completed dosing in the first cohort of a phase I/II study evaluating BEAM-302 for the treatment of alpha-1 antitrypsin deficiency. Initial clinical data from multiple cohorts of the study is expected in 2025.

BEAM is currently activating sites for the phase I/II study evaluating BEAM-301, an investigational in vivo base editing medicine, for treating glycogen storage disease Type Ia. Patient dosing in the study is expected to begin in 2025 in the United States.

Beam Therapeutics Inc. Price, Consensus and EPS Surprise

Beam Therapeutics Inc. price-consensus-eps-surprise-chart | Beam Therapeutics Inc. Quote

BEAM's Zacks Rank & Key Picks

Beam Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the biotech space are CRISPR Therapeutics AG CRSP, Atea Pharmaceuticals, Inc. AVIR and Amicus Therapeutics, Inc. FOLD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for CRISPR Therapeutics’ 2024 loss per share have narrowed from $5.58 to $5.55. Loss per share estimates for 2025 have narrowed from $4.98 to $4.94 during the same time. Year to date, shares of CRSP have decreased 19.5%.

CRSP’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 101.83%.

In the past 60 days, estimates for Atea Pharmaceuticals’ 2024 loss per share have narrowed from $2.55 to $2.22. Loss per share estimates for 2025 have narrowed from $2.58 to $1.80 during the same time. Year to date, shares of AVIR have increased 9.8%.

AVIR’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average surprise being 5.23%.

In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 17.2%.

FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.

Zacks Investment Research

Apellis Pharmaceuticals, Inc. APLS incurred third-quarter 2024 loss of 46 cents per share, wider than the Zacks Consensus Estimate of a loss of 32 cents. The company had incurred a loss of $1.17 per share in the year-ago quarter.

Total revenues in the third quarter amounted to $196.8 million and missed the Zacks Consensus Estimate of $199 million. In the year-ago quarter, the company had reported revenues of $110.4 million.

The top line jumped 78.3% year over year, owing to higher sales of Syfovre (pegcetacoplan injection) in the third quarter.

Syfovre was approved for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration by the FDA in February 2023.

Year to date, shares of Apellis have plunged 53.1% compared with the industry’s decline of 3.8%.

Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.

More on APLS' Q3 Results

Revenues in the third quarter included product sales of the marketed drugs — Empaveli (pegcetacoplan) and Syfovre — and licensing and other revenues under the collaboration agreement with Sobi.

Syfovre recorded sales of $152 million in the third quarter, which surged 101.8% year over year, owing to continued strong demand. However, Syfovre's sales missed the Zacks Consensus Estimate of $162 million but slightly beat our model estimate of $151.7 million.

Apellis delivered more than 84,500 commercial vials and nearly 4,000 samples of Syfovre to doctors in the third quarter. As of Sept 30, 2024, the total number of doses of the drug delivered since launch was 420,000.

The potential approval and successful launch of Syfovre in additional geographies will add an incremental stream of revenues to APLS in the future.

Empaveli recorded sales of $24.6 million in the third quarter, up 2.9% from the year-ago quarter’s figure, owing to continued high patient compliance rates of 97%. Empaveli sales were in line with the Zacks Consensus Estimate and beat our model estimate of $23.9 million.

Empaveli is approved in the United States for the treatment of paroxysmal nocturnal hemoglobinuria. The drug is also approved in Europe under the brand name Aspaveli for the same indication.

Licensing and other revenues came in at $20.3 million, up 81.3% year over year.

Research and development expenses increased 11.6% from the prior-year quarter’s level to $88.6 million. This was due to an increase in program-specific external costs and other external costs.

General and administrative expenses totaled $122 million, down 16.2% year over year. This was due to decreases in personnel-related costs, marketing activities, office costs, and professional and consulting fees.

As of Sept 30, 2024, Apellis had cash, cash equivalents and marketable securities worth $396.9 million compared with $360.1 million as of June 30, 2024. APLS expects its cash balance, combined with cash anticipated from sales of marketed products, to be enough to fund its operations in the foreseeable future.

APLS' Recent Pipeline Update

In September 2024, Apellis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency confirmed its June 2024 negative opinion on the regulatory filing for intravitreal pegcetacoplan to treat geographic atrophy secondary to age-related macular degeneration.

APLS also stated that the CHMP opinion was issued despite broad support for pegcetacoplan from the European retina community and several dissenting votes from CHMP members who had advocated for a path to approval.

In August 2024, Apellis and partner Sobi announced positive top-line data from the phase III VALIANT study evaluating systemic pegcetacoplan in C3 glomerulopathy (C3G) and primary immune complex glomerulonephritis (IC-MPGN) patients.

Per the data readout, the study achieved its primary endpoint, demonstrating a statistically significant and clinically meaningful 68% proteinuria reduction in C3G and IC-MPGN patients treated with pegcetacoplan versus placebo, both in addition to background therapy, at week 26.

Additionally, the study also achieved its key secondary endpoints with statistical significance, whereas nominal significance was observed on the histological endpoint. In the VALIANT study, pegcetacoplan was overall well-tolerated with a consistent safety profile.

Apellis is planning to submit a supplemental new drug application seeking approval for pegcetacoplan in C3G and IC-MPGN in early 2025. A similar regulatory filing by Sobi in the EU is also planned for early 2025.

Apellis Pharmaceuticals, Inc. Price, Consensus and EPS Surprise

Apellis Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Apellis Pharmaceuticals, Inc. Quote

APLS' Zacks Rank

Apellis currently carries a Zacks Rank #3 (Hold).

Key Biotech Picks

Some better-ranked stocks from this space are CRISPR Therapeutics AG CRSP, Atea Pharmaceuticals, Inc. AVIR and Amicus Therapeutics, Inc. FOLD, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for CRISPR Therapeutics’ 2024 loss per share have narrowed from $5.58 to $5.55. Loss per share estimates for 2025 have narrowed from $4.98 to $4.94 during the same time. Year to date, shares of CRSP have decreased 19.5%.

CRSP’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 101.83%.

In the past 60 days, estimates for Atea Pharmaceuticals’ 2024 loss per share have narrowed from $2.55 to $2.22. Loss per share estimates for 2025 have narrowed from $2.58 to $1.80 during the same time. Year to date, shares of AVIR have increased 9.8%.

AVIR’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average surprise being 5.23%.

In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 17.2%.

FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.

Zacks Investment Research

Vertex Pharmaceuticals Incorporated VRTX reported adjusted earnings of $4.38 per share for the third quarter of 2024, surpassing the Zacks Consensus Estimate of $4.13. In the year-ago quarter, the company had recorded adjusted earnings of $4.08 per share. Earnings grew year over year owing to increased product revenues.

The company reported total revenues of $2.77 billion for the third quarter, comprising cystic fibrosis (CF) product revenues. The figure beat the Zacks Consensus Estimate of $2.67 billion. Total revenues rose 12% year over year, primarily driven by higher sales of Trikafta/Kaftrio (marketed as Kaftrio in Europe).

Stay up-to-date with all quarterly releases: See Zacks Earnings Calendar.

More on VRTX's Q3 Earnings

The company currently markets four CF products — Trikafta/Kaftrio, Symdeko (marketed as Symkevi in Europe), Orkambi and Kalydeco.

CF product sales rose 10% year over year in the United States to $1.71 billion, while sales outside the United States increased 14% to $1.06 billion.

Trikafta generated sales worth $2.59 billion, up 13.7% year over year. Trikafta sales beat the Zacks Consensus Estimate and our model estimate of $2.48 billion and $2.45 billion, respectively.

Trikafta sales were driven by strong demand in both the United States and outside the U.S. market. In the outside U.S. market, growth was driven by continued uptake from the Kaftrio launches in children aged two to five years.

Sales from other CF products declined 10.6% year over year to $186.9 million. Sales of these drugs were hurt by patients switching to Trikafta.

Shares of Vertex have rallied 16.2% so far this year against the industry’s decline of 4%.

While CF remains the main area of focus, Vertex has seen rapid success in its non-CF pipeline candidates’ development in the past year. Vertex and partner CRISPR Therapeutics’ CRSP one-shot gene therapy Casgevy was approved for two blood disorders, sickle cell disease and transfusion-dependent beta-thalassemia, in multiple regions in late 2023/early 2024. Casgevy’s approval has diversified its commercial opportunity.

VRTX’s product revenues in the quarter included $2 million from Casgevy sales as the first patient was treated with the medicine. On the earnings call, the company mentioned that Casgevy has seen a strong launch so far.

Vertex leads the global development and commercialization of Casgevy under the terms of the 2021 agreement with support from CRISPR Therapeutics.

On the conference call, Vertex said that it now has more than 45 activated authorized treatment centers or ATCs in all regions where the therapy is approved, up from 35 at the end of the second quarter. Multiple patients have initiated cell collection.

VRTX's Cost Discussion

Adjusted research and development (R&D) expenses were up 5.2% year over year to $764 million due to higher investment in various ongoing clinical studies. Adjusted selling, general and administrative (SG&A) expenses increased 39.1% to $300.1 million in the reported quarter due to expenses for the commercial launch of Casgevy and pre-launch activities for suzetrigine.

During the reported quarter, Vertex recorded acquired in-process research and development (AIPR&D) costs of $15 million compared with $52 million reported in the year-ago quarter.

Adjusted operating income was $1.31 billion in the quarter, reflecting an increase of almost 12% year over year.

2024 Guidance

Vertex raised its total product sales guidance from a range of $10.65-$10.85 billion to $10.80-$10.90 billion for 2024. The revenue range indicates growth of 10% at the midpoint owing to the expected growth in CF. The revenue guidance also includes sales from Casgevy in approved indications and geographies.

Combined adjusted R&D and SG&A expenses for 2024 are expected in the band of $4.2 billion to $4.3 billion. Adjusted AIPR&D charges are expected to be approximately $4.6 billion for 2024, including Alpine acquisition costs recorded in the second quarter of 2024. The guidance for the adjusted R&D and SG&A expenses as well as adjusted AIPR&D charges remain unchanged from the previous expectation.

VRTX's Pipeline Update

Vertex has additional near-term launches planned. These include suzetrigine (VX-548) for acute pain and vanzacaftor triple for CF.

The FDA accepted Vertex’s new drug application (NDA), seeking approval for suzetrigine in moderate-to-severe acute pain in July 2024. The regulatory body has granted a priority review to the NDA, with a decision expected on Jan. 30, 2025.

Vertex has initiated a pivotal phase III program of suzetrigine in diabetic peripheral neuropathy, a form of peripheral neuropathic pain caused by damage to nerves. The company has also completed a phase II study on suzetrigine in patients with painful lumbosacral radiculopathy, another form of peripheral neuropathic pain. Data from this study is expected by 2024-end.

Per VRTX, suzetrigine has the potential to transform the treatment paradigm of pain, both acute and neuropathic. Pain is an area with limited treatment options, mostly highly addictive opioid-based medications.

Vertex’s NDA seeking approval for vanza triple, a next-in-class triple combination regimen for treating people with CF aged six years and older, is under review with the FDA. It has granted priority review to this NDA, with a decision expected on Jan. 2, 2025. Vertex’s regulatory application for vanza triple is also under review in the EU and some other countries.

Vanza triple is a combination of vanzacaftor, a CFTR potentiator, deutivacaftor, a CFTR corrector and tezacaftor. This new once-a-day oral combination medicine has the potential for enhanced patient benefit than Trikafta. It has the potential to become a new standard-of-care treatment in CF. It can potentially treat CF patients who have discontinued Trikafta or other Vertex CF medicines. It can also improve dosing (once daily) and lower the royalty burden.

Vertex has a rapidly advancing mid- to late-stage pipeline in other disease areas like APOL1-mediated kidney diseases, alpha-1 antitrypsin deficiency and cell therapy for type I diabetes.

During the quarter, Vertex initiated a phase II study with an oral formulation of next-gen Nav1.8 inhibitor, VX-993, for the treatment of moderate-to-severe acute pain following bunionectomy surgery. The candidate is also in phase I development for the IV formulation.

An oral formulation of VX-993 is also being investigated in a phase II study for treating diabetic peripheral neuropathy.

The acquisition of Alpine in May 2024 added povetacicept to Vertex’s pipeline. Povetacicept is designed to target two proteins, namely BAFF and APRIL, which are jointly responsible for the cause of multiple serious autoimmune diseases.

During the quarter, Vertex initiated the phase III RAINIER study on povetacicept for the treatment of IgA nephropathy. Povetacicept is also being evaluated in two phase II basket studies, one in renal diseases and a second in B cell mediated diseases.

Vertex Pharmaceuticals Incorporated Price, Consensus and EPS Surprise

Vertex Pharmaceuticals Incorporated price-consensus-eps-surprise-chart | Vertex Pharmaceuticals Incorporated Quote

VRTX's Zacks Rank

Vertex currently carries a Zacks Rank #3 (Hold).

Key Picks Among Biotech Stocks

Some better-ranked stocks from this space are Atea Pharmaceuticals, Inc. AVIR and Amicus Therapeutics, Inc. FOLD, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Atea Pharmaceuticals’ 2024 loss per share have narrowed from $2.55 to $2.22. Loss per share estimates for 2025 have narrowed from $2.58 to $1.80 during the same time. Year to date, shares of AVIR have increased 9.8%.

AVIR’s earnings beat estimates in two of the trailing four quarters while missing on the remaining two occasions, the average surprise being 5.23%.

In the past 60 days, estimates for Amicus’ 2024 earnings per share have moved up from 21 cents to 22 cents. Earnings per share estimates for 2025 have improved from 50 cents to 53 cents during the same time. Year to date, shares of FOLD have declined 20.2%.

FOLD’s earnings beat estimates in three of the trailing four quarters while missing on the remaining occasion, the average surprise being 23.96%.

Zacks Investment Research