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Tuesday, August 1, 2023

IQVIA cuts annual profit forecast on soft demand for healthcare tech services

Contract research firm IQVIA Holdings cut its annual profit and revenue forecasts on Tuesday, on expectations of slower demand from clients for its healthcare data and analytics services.

Its Technology & Analytics Solutions unit, IQVIA's second largest, through which it provides services such as information on drug prescription trends and data and tech-based services for drug trials, brought in revenue of $1.46 billion, below estimates of $1.47 billion.

"Clients on the commercial side remain cautious and spending has not accelerated yet", said CEO Ari Bousbib.

The Durham, North Carolina-based company now expects full-year adjusted profit to be between $10.20 and $10.45 per share, cut from its per share prior forecast of $10.26 to $10.56.

Analysts were expecting annual profit of $10.39 per share, according to Refinitiv.

IQVIA expects its 2023 revenue to grow between 8% to 9%, lower than its prior outlook of between 9% to 11% growth.

The company, however, reported better-than-expected second-quarter profit and revenue, on the back of strong demand for its drug research and development services.

IQVIA's revenue for its research and development solutions unit, which helps run clinical trials for companies, rose 7.7% to $2.10 billion, beating analysts' expectations of $2.07 billion.

It reported revenue of $3.73 billion for the quarter ended June 30, slightly above analysts' average estimate of $3.71 billion. Excluding one-off items, IQVIA reported a profit of $2.43 per share for the second quarter, above analysts' average estimate of $2.37 per share.

https://finance.yahoo.com/news/iqvia-cuts-annual-profit-forecast-132247939.html

Revolution Medicines to Acquire EQRx in All-Stock Transaction to Gain Over $1 in AdBditional Capital

 Revolution Medicines Expects to Conduct Late-Stage Development of RAS(ON) Inhibitor Drug Candidate Pipeline Supported by Fortified Balance Sheet

Agreement is the Result of a Rigorous Process Conducted by Independent Transaction Committee of EQRx Board to Consider Strategic Alternatives to Maximize Value for EQRx Stockholders

Transaction Expected to Close in November 2023

Revolution Medicines, Inc. (“Revolution Medicines” or the “Company”) (Nasdaq: RVMD), a clinical-stage oncology company developing targeted therapies for RAS-addicted cancers, and EQRx, Inc. (“EQRx”) (Nasdaq: EQRX) today announced a definitive agreement through which Revolution Medicines plans to acquire EQRx in an all-stock transaction intended to add more than $1 billion in net cash to Revolution Medicines’ balance sheet. The total number of shares of Revolution Medicines common stock to be issued to EQRx security holders will be determined in close proximity to the closing of the stockholder votes on the transaction based on the formula described below (see Transaction Details section). The deal, which was overseen by independent committees of Revolution Medicines’ and EQRx’s respective boards of directors, has been approved by the directors of each company. The transaction, which is subject to customary closing conditions, will enhance Revolution Medicines’ efforts to fulfill its vision to discover, develop and deliver pioneering RAS(ON) Inhibitor drugs on behalf of patients with RAS-addicted cancers.

This proposed transaction is intended to reinforce and sustain Revolution Medicines’ parallel development approach for its extensive RAS(ON) Inhibitor pipeline in multiple RAS-driven cancers by enhancing its balance sheet, increasing financial certainty in a challenging macroenvironment. With encouraging data trends thus far for its RASMULTI(ON) Inhibitor RMC-6236, planning is underway for one or more single agent pivotal clinical trials potentially to begin in 2024. Likewise, with encouraging initial clinical experience with its KRASG12C(ON) Inhibitor RMC-6291, planning is underway for a Phase 1/1b clinical trial to evaluate the combination of RMC-6236 and RMC-6291 potentially to begin in early 2024, while continuing single agent evaluation of RMC-6291. Revolution Medicines’ acquisition of EQRx reflects both companies’ confidence in Revolution Medicines’ ability to deploy this amount of capital effectively. With the additional capital, Revolution Medicines will be positioned to maximize the potential clinical impact of its targeted drug pipeline across multiple oncology indications, and thereby offers the potential for shareholder value creation while retaining strategic control of its RAS(ON) Inhibitor pipeline.

ABVC Signs a Term Sheet to Earn Licensing Fees of up to $20M and Royalties of 5-12% of Net Sales

  ABVC Biopharma, Inc. (NASDAQ: ABVC), a clinical-stage biopharmaceutical company developing therapeutic solutions in oncology/hematology, neurology, and ophthalmology, today announced the signing of a legally binding term sheet with a prominent Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd that, subject to definitive agreements, is for the exclusive licensing of ABV-1504 for Major Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit/Hyperactivity Disorder in mainland China.

Under this landmark agreement, Xinnovation Therapeutics Co., Ltd will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for MDD and ADHD in the Chinese market and shall bear the costs for clinical trials and product registration in China. The licensing deal carries a possible aggregate income of $20 million for ABVC. The term sheet outlines the key terms and conditions of the licensing agreement. The final agreement, expected to be formally signed within one year, will specify the precise licensing terms, including the schedule for milestone payments and other financial arrangements. As per the term sheet, ABVC expects to receive royalty payments ranging from 5% to 12% based on the projected annual net sales of licensed drugs in China, which we believe would bring ABVC's revenue ~$50 million annually and ~$1 billion during the patent life of these products, if we achieve the expected amount of sales. The final agreement is subject to the satisfaction of closing conditions, and the transaction will not occur if they are not satisfied or waived within one year.

https://finance.yahoo.com/news/abvc-signs-term-sheet-earn-123000150.html

Rhythm Q2 results and progress report

 Second quarter 2023 net revenue of $19.2 million from global sales of IMCIVREE® (setmelanotide) --

-- Strong U.S. commercial progress continues with more than 125 new prescriptions for Bardet-Biedl syndrome (BBS) in 2Q 2023, more than 425 since FDA approval --

-- Achieved commercial sales milestone and now eligible to receive third investment tranche of $25 million from Healthcare Royalty Partners --

-- Announced plans to submit an investigational new drug application for RM-718, a new, weekly, MC4R-specific agonist, by end of 2023 --

-- Enrollment ongoing in pivotal Phase 3 trial evaluating setmelanotide in hypothalamic obesity; based on rapid progress, study now expected to be fully enrolled by the end of 2023 --

-- Management to host conference call today at 8:00 a.m. ET --

Financial Guidance: For the year ending December 31, 2023, Rhythm continues to anticipate approximately $200 million to $220 million in Non-GAAP Operating Expenses (see below under "Non-GAAP Financial Measures" for more details), comprised of $120 million to $130 million from R&D expenses and $80 million to $90 million from S,G&A expenses. Based on its current operating plans, Rhythm expects that its existing cash, cash equivalents and short-term investments as of June 30, 2023, together with the anticipated $25 million milestone payment based on commercial sales from Healthcare Royalty Partners, will be sufficient to fund its operating expenses and capital expenditure requirements into 2025.

Conference Call Information
Rhythm Pharmaceuticals will host a live conference call and webcast at 8:00 a.m. ET today to review its second quarter 2023 financial results and recent business activities. Participants may register for the conference call here. It is recommended that participants join the call ten minutes prior to the scheduled start.

A live webcast of the call will also be available under "Events and Presentations" in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the conference call and will be available for 30 days following the call.

https://finance.yahoo.com/news/rhythm-pharmaceuticals-reports-second-quarter-110000105.html

Merck Posts Narrower-Than Expected Loss, Lifts Sales Outlook on Keytruda

 Merck & Co.  (MRK) - Get Free Report on Tuesday posted a narrower-than-expected second-quarter loss while boosting its full-year sales forecast, thanks to solid revenue from its blockbuster Keytruda cancer treatment.

Merck said its adjusted loss for the three months ended in June came in at $2.06 a share, compared with a profit of $1.18 a share in the year-earlier period and the Wall Street consensus forecast of $2.18 a share. The group took a $4.02-per-share hit linked to its $10.8 billion purchase of Prometheus Biosciences, which closed last month.

Group revenue, Merck said, rose 3% to $15.04 billion, against the $14.45 billion tally forecast by analysts that cover the pharma giant.

Keytruda sales surged 19% from a year earlier to $6.3 billion, Merck said, while sales of its covid antiviral pill Lagevrio, which it developed with Ridgeback Therapeutics, fell 83% to $203 million.

Looking into back half of the year, Merck said it saw full-year adjusted earnings in the range of $2.95 to $3.05 per share. Worldwide sales are pegged between $58.6 billion and $59.6 billion, up from its prior forecast of $57.2 billion to $58.7 billion.

"We continue to make great progress as we advance our broad and deep pipeline, raise the bar of innovation, and bring forward leading-edge science to save and improve lives around the world," said CEO Robert Davis. 

"We delivered robust underlying growth during the second quarter and are well positioned to achieve strong full-year results," he added.

https://www.thestreet.com/investing/stocks/merck-posts-narrower-loss-lifts-sales-forecast-on-keytruda-boost

Pfizer Covid Sales Extend Slump, Clouding Q2 Earnings Beat

 Pfizer  (PFE) - Get Free Report posted stronger-than-expected second-quarter earnings Tuesday, but slowing covid sales led to a softer revenue tally that will likely extend into the back half of the year. 

Pfizer said adjusted earnings for the three months ended in June were 67 cents per share, a 67% decrease from the year-earlier period but 10 cents ahead the Wall Street consensus forecast of 57 cents per share. 

Group revenue, Pfizer said, fell 54% to $12.74 billion, missing analysts' estimates of a $13.33 billion tally amid a pullback in sales of its Paxlovid antiviral treatment.

Looking into second half of the year, Pfizer said it saw group revenue in the region of $67 billion to $70 billion, trimming the upper end of its prior forecast -- with around $13.5 billion in sales of its Comirnaty covid vaccine and $8 billion in sales for Paxlovid.

“Pfizer has made significant progress toward our goal to launch 19 new products and indications in an 18-month span, having executed 11 launches thus far. We continue to build momentum in 2023, recently attaining key milestones for several products," said CEO Albert Bourla.

"We also continue to make progress toward our proposed acquisition of Seagen," he added. "In addition to receiving approval of the transaction from Seagen shareholders and planning for the potential integration of the two companies, we continue to work closely with regulators, including the Federal Trade Commission and the European Commission, and are working diligently to fulfill requests for further information from the FTC."

Pfizer shares were marked 0.72% lower in premarket trading immediately following the earnings release to indicate an opening bell price of $35.80 each.

Seagen, which has developed treatments known as antibody-drug conjugates that target specific cancers, generated around $2 billion in revenue last year and has a market value of around $30 billion. Pfizer generated around $3 billion in oncology-related revenues last year, the bulk of it coming from its Ibrance breast cancer treatment. 

Last week, rival drugmaker Bristol Myers Squibb  (BMY) - Get Free Report cut its full-year sales outlook amid increasing generic competition for two of its key drugs

Eliquis, a blood-thinning treatment it shares with Pfizer, booked $3.2 billion in second-quarter sales for Bristol Myers, down 1% from the previous year and around $200 million shy of analysts' forecasts. 

https://www.thestreet.com/investing/stocks/pfizer-covid-sales-extend-slump-clouding-q2-earnings-beat

TG Therapeutics results miss

 Second quarter 2023 BRIUMVI® net sales of $16 million in the United States, representing 100% quarter over quarter growth; total net revenue of approximately $24 million since launch

Over 1,200 BRIUMVI prescriptions since launch from 340+ healthcare providers at 225+ centers across the U.S.

Payor coverage in place for approximately 80% of covered lives for BRIUMVI

Agreement with Neuraxpharm for the ex-U.S. commercialization of BRIUMVI in RMS strengthens balance sheet with pro-forma cash balance, inclusive of the upfront payment, of approximately $285 million

Conference call to be held today, August 1, 2023, at 8:30 AM ET

The Company will host a conference call today, August 1, 2023, at 8:30 AM ET, to discuss the Company’s financial results from the second quarter, ended June 30, 2023, the Neuraxpharm ex-U.S. commercialization agreement, and provide a business outlook for the remainder of 2023.

To participate in the conference call, please call 1-877-407-8029 (U.S.), 1-201-689-8029 (outside the U.S.), Conference Title: TG Therapeutics. A live audio webcast will be available on the Events page, located within the Investors & Media section, of the Company's website at http://ir.tgtherapeutics.com/events. An audio recording of the conference call will also be available for a period of 30 days after the call.

https://finance.yahoo.com/news/tg-therapeutics-provides-business-reports-111500703.html