Intellia results, outlook, call

 

• Dosed first patient in the global Phase 2 study of NTLA-2002 for the treatment of hereditary angioedema (HAE)

• Expects to complete enrollment in the Phase 2 study of NTLA-2002 in 2H 2023

• Plans to submit IND application in mid-2023 for a global pivotal study of NTLA-2001 for the treatment of transthyretin (ATTR) amyloidosis with cardiomyopathy; study initiation anticipated by year-end 2023, subject to regulatory feedback

• On track to present additional clinical data in 2023 from both ongoing NTLA-2001 and NTLA-2002 first-in-human studies

• Progressing next wave of clinical candidates, including NTLA-3001 and NTLA-2003, and advancing novel gene editing capabilities

• Ended the first quarter of 2023 in a strong financial position with approximately $1.2 billion in cash

The Company will discuss these results on a conference call today, Thursday, May 4, at 8 a.m. ET.
To join the call:

• U.S. callers should dial 1-833-316-0545 and international callers should dial 1-412-317-5726, approximately five minutes before the call. All participants should ask to be connected to the Intellia Therapeutics conference call.

• Please visit this link for a simultaneous live webcast of the call.
  

A replay of the call will be available through the Events and Presentations page of the Investors & Media section on Intellia’s website at intelliatx.com, beginning on May 4, at 12 p.m. ET.

https://finance.yahoo.com/news/intellia-therapeutics-announces-first-quarter-113000643.html

Regeneron's Eylea drug sales hit by competition

 Regeneron Pharmaceuticals Inc's first-quarter sales of blockbuster eye drug Eylea came in below Wall Street targets on Thursday as competition heated up, dragging the company's shares more than 5% lower in early trade.

Eylea, jointly developed with Bayer AG, has been a key growth driver for Regeneron for years, but its sales have fallen over the past few quarters, partly due to rising competition from Roche's Vabysmo since the rival secured U.S. approval last year.

"I say there's a little bit of a new-kid-in-town kind of effect," said EF Hutton & Co analyst Michael King, as doctors may be willing to give Vabysmo a try because it is the newest drug in the market.

Regeneron is pinning its hopes on approval for a high-dose version of Eylea that could allow longer intervals between injections for patients - a feature that analysts expect will offer the company a better defense against Vabysmo.

The quarterly results from Regeneron "place even more emphasis on the need for near-flawless execution with the upcoming approval and likely launch" of high-dose Eylea, BMO Capital Markets analyst Evan Seigerman said in a note.

Quarterly Eylea sales of $2.28 billion missed analysts' expectations of $2.43 billion, according Refinitiv data.

Low-dose Eylea is expected to become a smaller share of the company's revenue if the higher-dose version gains approval, Regeneron CEO Leonard Schleifer said.

The U.S. health regulator's decision on the new version is expected by June 27.

The company has also been leaning on its anti-inflammatory drug Dupixent - a treatment currently approved for five indications including asthma and atopic dermatitis, or eczema.

Quarterly sales of Dupixent, recorded by partner Sanofi, rose about 37% to $2.49 billion, helping Regeneron beat quarterly profit estimates.

Analysts said the beat was also driven by better-than-expected collaboration revenues.

https://finance.yahoo.com/news/regeneron-beats-quarterly-profit-estimates-103955005.html

Organon: Guidance largely unchanged; call

 Full Year Guidance

Organon does not provide GAAP financial measures on a forward-looking basis because the company cannot predict with reasonable certainty and without unreasonable effort, the ultimate outcome of legal proceedings, unusual gains and losses, the occurrence of matters creating GAAP tax impacts, and acquisition-related expenses. These items are uncertain, depend on various factors, and could be material to Organon’s results computed in accordance with GAAP. Organon's financial guidance does not assume an estimate for future in-process research and development for business development transactions not yet executed.

Full year 2023 financial guidance is presented below on a non-GAAP basis.

	Previous guidance as of February 16, 2023	Current guidance
Revenues	$6.150 billion - $6.450 billion	Unchanged
Adjusted gross margin	Low-mid 60% range	Unchanged
SG&A (as % of revenue)	Mid 20% range	Unchanged
R&D1 (as % of revenue)	Upper single-digit	Unchanged
Adjusted EBITDA margin	31.0%-33.0%	Unchanged
Interest	~$510 million	~$515 million
Depreciation	~$130 million	Unchanged
Effective non-GAAP tax rate	19.0% - 21.0%	Unchanged
Fully diluted weighted average shares outstanding	~255 million	~257 million
1 The range provided for estimated R&D spend includes the company's estimate of approximately $40 million for IPR&D for the full year 2023 which is based on estimated milestones that may be achieved in 2023 by products in the company's current portfolio. Organon's financial guidance does not assume an estimate for future IPR&D for business development transactions not yet executed.

Webcast Information

Organon will host a conference call at 8:30 a.m. Eastern Time today to discuss its first quarter 2023 financial results. To listen to the event and view the presentation slides via webcast, join from the Organon Investor Relations website at https://www.organon.com/investor-relations/events-and-presentations/. A replay of the webcast will be available approximately two hours after the conclusion of the live event on the company’s website. Institutional investors and analysts interested in participating in the call must register in advance by clicking on this link: https://conferencingportals.com/event/jgIqShwa

Following registration, participants will receive a confirmation email containing details on how to join the conference call, including dial-in information and a unique passcode and registrant ID. Pre-registration will allow participants to bypass an operator and be placed directly into the call.

https://finance.yahoo.com/news/organon-reports-results-first-quarter-113000473.html

Immunic: Positive Results From Phase 1b in Celiac Disease

 Positive Effects Demonstrated Over Placebo in Four Key Dimensions of Celiac Disease Pathophysiology: Protection of Gut Architecture, Improvement of Patients' Symptoms, Biomarker Response, and Enhancement of Nutrient Absorption –

– Corroborates Hypothesized Ability of IMU-856 to Renew Gut Wall and Restore Gut Health –

– No Safety or Tolerability Issues Detected –

– Conference Call and Webcast to be Held Today, May 4, 2023 at 8:00 am ET –

Immunic will host a webcast today, May 4, 2023, at 8:00 am ET to discuss these results. To participate in the webcast, please register in advance at: https://imux.zoom.us/webinar/register/WN_EbVhqfsaTGCXeAromYvIcA or on the "Events and Presentations" section of Immunic's website at: ir.imux.com/events-and-presentations. Registrants will receive a confirmation email containing a link for online participation or a telephone number for dial in access.

An archived replay of the webcast will be available approximately one hour after completion on Immunic's website at: ir.imux.com/events-and-presentations.

https://finance.yahoo.com/news/immunic-reports-positive-results-phase-103000333.html

Karyopharm Cuts Outlook

 Based on its current operating plans, Karyopharm is updating its guidance for full year 2023:

• Total revenue to be in the range of $145 million to $160 million versus previous guidance of $160 million to $175 million. Total revenue consists of U.S. XPOVIO net product revenue and license, royalty and milestone revenue earned from partners.

• U.S. XPOVIO net product revenue to be in the range of $110 million to $125 million versus previous guidance of $125 million to $140 million, driven by the expectation that the increased use of PAP will continue in 2023, including a cumulative effect from refills.

• Non-GAAP R&D and SG&A expenses*, which exclude stock-based compensation expense, to be in the range of $245 million to $260 million versus previous guidance of $260 million to $280 million, driven by accelerated closure of non-priority programs and ongoing disciplined execution.

• The Company continues to expect that its existing cash, cash equivalents and investments, and the revenue it expects to generate from XPOVIO product sales, as well as revenue generated from its license agreements, will be sufficient to fund its planned operations into late 2025.

* Karyopharm has not reconciled the full year 2023 outlook for non-GAAP R&D and SG&A expenses to full year 2023 outlook for GAAP R&D and SG&A expenses because Karyopharm cannot reliably predict without unreasonable efforts the timing or amount of the factors that substantially contribute to the projection of stock compensation expense, which is excluded from the full year 2023 outlook for non-GAAP R&D and SG&A expenses.

https://finance.yahoo.com/news/karyopharm-reports-first-quarter-2023-114500570.html

Ionis upped to Neutral from Sell by Citi

 Target to $36 from $30

https://finviz.com/quote.ashx?t=IONS&ty=c&ta=1&p=d

Plummeting bank stocks test predictions that worst of the crisis is over

 Federal Reserve Chair Jerome Powell said Wednesday that the seizure of First Republic was "an important step toward drawing a line under" turmoil in the banking system. Within two hours the stock of another troubled regional lender was down more than 50%.

The trigger was a series of media reports that Beverly Hills, Calif.-based PacWest (PACW) was weighing a range of strategic options, including a sale or capital raise. Its stock continued to fall during Thursday morning trading, down by more than 52% after being halted temporarily.

Other regional banks under scrutiny from investors also plunged, including Phoenix-based Western Alliance (WAL), which is also reportedly considering a sale of all or parts of its business. A Memphis-based lender, First Horizon (FHN), plummeted more than 38% Thursday after Toronto-Dominion Bank called off its deal to acquire the company.

The new round of volatility for regional banks punctuates a disconnect in the financial world as the industry’s unrest drags into an eighth week.

While top figures on Wall Street and Washington display optimism that the worst is over, investors continue to punish other regional lenders that share any characteristics of the three mid-sized banks already seized by regulators.

PacWest Bancorp (PACW)

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'The regional banking system is at risk'

On Monday JPMorgan Chase (JPM) CEO Jamie Dimon captured the industry’s hopes when he said "this part of the crisis is over" after announcing JPMorgan’s purchase of First Republic. Jane Fraser, CEO of Citigroup (C), on Monday called First Republic "the last remaining main uncertainty of the small handful of banks that did not do a good job with asset liability management."

Powell reinforced this view on Wednesday, citing the failures of First Republic, Silicon Valley Bank and Signature Bank as the "three large banks really from the very beginning that were at heart of the stress we saw in early March," he said.

https://finance.yahoo.com/news/plummeting-bank-stocks-test-predictions-that-worst-of-the-crisis-is-over-123744150.html