Dexcom grows revenues 18% in Street-beating Q1, raises guidance

 Dexcom (Nasdaq:DXCM) today announced that it’s raising its 2023 financial guidance following strong first-quarter financial results.

Shares of DXCM dipped 3.7% to $119 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The San Diego-based continuous glucose monitor technology developer posted profits of $48.6 million. That equals 12¢ per share on sales of $741.5 million for the three months ended March 31, 2023.

Dexcom reported a 50% bottom-line slide on sales growth of 17.9%. The company attributed sales growth to strong new customer additions. Dexcom noted this continues to drive revenue growth as awareness of real-time CGM increases.

Highlights in the quarter included the U.S. launch of the next-generation Dexcom G7 CGM, initiated with a Super Bowl commercial. The company also finalized coverage for G7 with the Centers for Medicare and Medicaid Services (CMS) in February. Earlier this month, the company got a boost from new CMS changes that expand access to its CGMs.

Adjusted to exclude one-time items, earnings per share totaled 17¢. That landed 2¢ ahead of projections on Wall Street. Sales topped expectations, too, as analysts forecast $720.7 million in revenue.

“Dexcom is off to a great start in 2023, executing on several key initiatives including the launch of Dexcom G7 in the United States,” said Kevin Sayer, Dexcom chair, president and CEO. “Given the strength of our first quarter results and an expanding market opportunity with new CGM coverage now available, we are pleased to raise our 2023 revenue guidance.”

Dexcom projects revenues to land between $3.4 billion and $3.515 billion for the full year. That represents 17% to 21% growth year over year. It also marks an increase from the previous guidance for between $3.35 billion and $3.49 billion.

https://www.drugdeliverybusiness.com/dexcom-revenues-guidance-q1-2023/

Curium, H.I.G. Reportedly Compete for $2B Cardinal Health Unit

 Curium Pharma, a French maker of medical imaging supplies, and buyout firm H.I.G. Capital are among suitors shortlisted in the bidding for Cardinal Health Inc.’s nuclear medicine business, people familiar with the matter said.

Cardinal has invited the remaining bidders to submit final offers by mid-May, the people said, asking not to be identified as the matter is private. A deal could value the business at about $2 billion or more, according to the people.

Bloomberg News first reported in March that Cardinal was weighing a potential sale of the nuclear medicine business. Cardinal said in September it would review its strategy, portfolio, capital-allocation plans and operations after activist investor Elliott Investment Management took a stake in the company. The unit makes radioactive agents and drugs that doctors use to diagnose and treat diseases like cancer.

Deliberations are ongoing, and there’s no certainty the suitors will proceed with final bids, the people said. Representatives Cardinal, Curium and H.I.G. declined to comment.

Curium, which is owned by private equity firm CapVest Ltd., provides materials used to help diagnose cancer as well as heart, brain and bone diseases. The company was created following the 2017 merger of IBA Molecular with a Mallinckrodt Plc business.

Healthcare dealmaking has remained relatively robust against a broader drop off in mergers and acquisitions this year. Cardinal is among a growing list of health-care companies that are spinning off or selling non-core businesses to focus on growth opportunities.

Medical devicemaker Medtronic Plc is in the process of spinning off its patient-monitoring and respiratory-intervention businesses, while General Electric Co.’s former medical-equipment division began trading as a separate company this year.

https://www.themiddlemarket.com/news-analysis/curium-hig-reportedly-compete-for-2-billion-cardinal-health-unit

Why Teladoc Stock Popped

 Shares of Teladoc Health (TDOC 6.36%), a telehealth company, jumped today after the company reported revenue and earnings that surpassed Wall Street's expectations in the first quarter. The strong quarter prompted management to increase its earnings and revenue outlook for the full year, which likely contributed to investors' enthusiasm today. 

The stock rose by as much as 9% on Thursday and was up by 6.4% as of 2:51 p.m. ET. 

Teladoc reported an adjusted loss of $0.42 per share in the quarter, which was better than the analysts' consensus average estimate of a loss of $0.51. Revenue also impressed investors as sales of $629 million rose 11% from the year-ago quarter and outpaced Wall Street's consensus estimate of $618 million. 

"We have solid momentum heading into the rest of the year as the market embraces Teladoc Health's unified whole-person care experience," CEO Jason Gorevic said in a press release. 

Management also noted that margins improved in the quarter, with the adjusted gross margin increasing from 66.9% in the year-ago quarter to 69.8%.

Teladoc's strong first-quarter results led the company's management to increase its earnings and revenue guidance for the full year. The company now expects a loss of between $1.25 and $1.70 per share for 2023, compared to the previous range of between $1.25 to $1.75.

And the company is guiding for full-year revenue to be $2.63 billion at the midpoint of guidance, up from the previous estimate of $2.61 billion. 

With the company delivering solid results in the quarter and increasing its outlook for the full year, it's not surprising to see the telehealth stock climbing higher today. 

https://www.fool.com/investing/2023/04/27/why-teladoc-stock-popped-today/

Gilead Light Profit Hamstrings Strong Cancer Drug Sales

 Biotech giants Gilead Sciences (GILD) and Amgen (AMGN) posted mixed quarters on Thursday — leading GILD stock and Amgen stock to topple.

For Gilead, total revenue inched down roughly 4% to $6.35 billion, a hair above forecasts for $6.33 billion, according to FactSet. Adjusted earnings came in at $1.37 per share, down 35%. The earnings decline was driven by a tax impairment, but missed projections for $1.54 a share.

Meanwhile, Amgen's adjusted profit came in well ahead of forecasts at $3.98 per share, but sales missed views and fell 2% to $6.105 billion. Like its biotech peer, Amgen's profit fell due to a tax impairment. Amgen also noted decreased revenue and higher operating expenses, leading to a 6% earnings decline. Analysts expected lower earnings of $3.81 a share, but slightly higher sales at $6.113 billion.

In after-hours trading on today's stock market, GILD stock toppled 2.5% near 81.50. Amgen stock fell 2.3% near 234.80.

GILD Stock: Covid Sales Dive

The lion's share of Gilead's sales decline was driven by light sales of Covid treatment, Veklury.

Gilead is far from the first drugmaker to see a revenue slope due to Covid-related products. This week, Merck (MRK), Roche (RHHBY) and GSK (GSK) all reported short — or nonexistent — sales of their Covid products. Covid cases reported to the Centers for Disease Control and Prevention peaked in mid-January and have since trended down.

During the first quarter, Veklury sales plummeted 63% to $573 million. Excluding the impact of Veklury, Gilead's sales actually increased 15%.

"Biktarvy (and HIV treatment) outperformed once again, and oncology revenue increased 59% year over year, driven by Trodelvy and cell therapy," Gilead Chief Executive Daniel O'Day said in a written statement.

Sales of Trodelvy, which treats breast and bladder cancer, surged 52% to $222 million and topped GILD stock analysts' forecast for $217 million. Revenue from cell therapies Yescarta and Tecartus also beat the Street's expectations at a respective $359 million and $89 million. Yescarta sales climbed 70% as Tecartus sales surged 40%.

Revenue from Biktarvy also popped 24% to $2.68 billion, ahead of estimates for $2.52 billion.

For the year, Gilead expects $26 billion to $26.5 billion in product sales. GILD stock analysts predicted $26.3 billion in product sales — which excludes other sources of revenue like licensing and royalty deals.

The guidance includes expectations for $2 billion from Veklury sales, a decline of 49% and in line with analyst forecasts for $2.03 billion.

Analysts see adjusted earnings at $6.60-$7 per share. Also, analysts called for $6.85 earnings per share.

Amgen Stock: Amjevita Takes Stage

The strongest growth among Amgen's products came from its new Humira biosimilar, Amjevita. Amjevita launched in the U.S. in February, though it has been on the market for several years in Europe. Sales surged 52% to $164 million.

Behind Amjevita, Amgen reported strong sales increases for osteoporosis treatment Evenity, cancer drug Blincyto and low platelet treatment Nplate. Sales surged a respective 49%, 41% and 36%. The company's biggest moneymaker, osteoporosis treatment Prolia, brought in $927 million in sales, up 9%.

But revenue from migraine treatment Aimovig slumped 32% to $69 million due to unfavorable changes in sales deductions and lower net selling price. Amgen expects the trend of lower sales prices to continue in an effort to remain competitive.

For the year, Amgen guided to $26.2 billion to $27.3 billion in sales and adjusted profit of $17.60-$18.70 per share. Amgen stock analysts predicted a respective $27.65 billion and $17.91.

https://www.investors.com/news/technology/gild-stock-gilead-earnings-amgen-stock-amgen-earnings-q1-2023/

FDA OKs Pfizer’s 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

 

• PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine

• PREVNAR 20 builds on PREVNAR 13® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases.1

• The vaccine further advances Pfizer’s pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines

https://finance.yahoo.com/news/u-fda-approves-prevnar-20-194200076.html

Iran Seizes Houston-Bound Oil Tanker In Gulf, US Navy Says

 The US Navy announced Thursday that Iranian commandos have seized a Marshall Islands-flagged oil tanker in the Gulf of Oman off Iran's coast. The statement emphasized that the seizure happened in international waters.

The US statement identified the ship as the Advantage Sweet Suezmax crude tanker chartered by Chevron to move product from Kuwait to Houston. The US administration is calling on Iran's government to immediately release the oil tanker, according to Bloomberg.

"Iran's continued harassment of vessels and interference with navigational rights in regional waters are a threat to maritime security and the global economy," the US Navy said. The statement further reviewed that in two years, the Islamic Republic has unlawfully seized at least five commercial vessels in the region.

Iran's state television IRIB News confirmed Iranian possession of the tanker. Iran's military is claiming the vessel collided with an Iranian boat and then tried to flee. "A Marshall Islands-flagged oil tanker was seized by the Iranian army’s naval force in the Persian Gulf after it collided with an Iranian boat in the Gulf of Oman and tried to flee," the Iranian military said. "Two members of the boat’s crew are missing and several were injured due to the collision of the ship with the boat," it claimed.

The vessel's Turkey-based management company said as quoted in Reuters, "The safety and welfare of our valued crew members is our No. 1 priority," adding that: "Similar experiences show that crew members of vessels taken under such circumstances are in no danger."

Iran especially since 2019, a year after the Trump administration pulled out of the JCPOA nuclear deal brokered under Obama, increased its threats to close the Strait of Hormuz narrow waterway by force - vital to global trade and oil transit - if it’s prevented from using it.

The past few years have witnessed the US ramp up its naval presence in the Gulf region, based out of Bahrain where the 5th Fleet is headquartered, and this has served to increase tense encounters between IRGC operatives and US forces.

For example the past half-year has seen the Iranians briefly capture and detain high-tech US navy sea drones. But these all have been released by the Iranians after the US Navy mobilizes assets in threat of IRGC vessels. 

The past year has seen the near total collapse of negotiations toward restoring the nuclear deal. Many analysts feared that a stalled deal would only cause the Iranians to resort to military tactics in order to build leverage toward forcing a US response, and that may be precisely what we are seeing now with this latest tanker seizure. 

https://www.zerohedge.com/geopolitical/iran-seizes-houston-bound-oil-tanker-gulf-us-navy-says

High fried food impacts anxiety, depression due to lipid metabolism disturbance, neuroinflammation

 Anli Wang, Xuzhi Wan, Pan Zhuang, +13, and Yu Zhang https://orcid.org/0000-0003-1025-906X y_zhang@zju.edu.cnAuthors Info & Affiliations

https://doi.org/10.1073/pnas.222109712

Significance

To address a crucial knowledge deficiency concerning the correlation between fried food consumption and the risk of anxiety and depression, here we revealed that frequent fried food consumption is strongly associated with a higher risk of anxiety and depression. Notably, acrylamide is a representative contaminant in fried foods, thereby further elucidating its toxicological mode of action. We demonstrated that long-term exposure to acrylamide induces anxiety- and depressive-like behaviors via oxidative stress-mediated neuroinflammation, and unravel the underlying mechanism that PPAR signaling pathway mediates acrylamide-induced lipid metabolism disorder in brain. These outcomes are expected to both epidemiologically and mechanistically open an avenue in the significance of reducing fried food consumption for mental health and provide evidence to understand acrylamide-triggered anxiety and depression.

Abstract

Western dietary patterns have been unfavorably linked with mental health. However, the long-term effects of habitual fried food consumption on anxiety and depression and underlying mechanisms remain unclear. Our population-based study with 140,728 people revealed that frequent fried food consumption, especially fried potato consumption, is strongly associated with 12% and 7% higher risk of anxiety and depression, respectively. The associations were more pronounced among male and younger consumers. Consistently, long-term exposure to acrylamide, a representative food processing contaminant in fried products, exacerbates scototaxis and thigmotaxis, and further impairs exploration ability and sociality of adult zebrafish, showing anxiety- and depressive-like behaviors. Moreover, treatment with acrylamide significantly down-regulates the gene expression of tjp2a related to the permeability of blood–brain barrier. Multiomics analysis showed that chronic exposure to acrylamide induces cerebral lipid metabolism disturbance and neuroinflammation. PPAR signaling pathway mediates acrylamide-induced lipid metabolism disorder in the brain of zebrafish. Especially, chronic exposure to acrylamide dysregulates sphingolipid and phospholipid metabolism, which plays important roles in the development of anxiety and depression symptoms. In addition, acrylamide promotes lipid peroxidation and oxidation stress, which participate in cerebral neuroinflammation. Acrylamide dramatically increases the markers of lipid peroxidation, including (±)5-HETE, 11(S)-HETE, 5-oxoETE, and up-regulates the expression of proinflammatory lipid mediators such as (±)12-HETE and 14(S)-HDHA, indicating elevated cerebral inflammatory status after chronic exposure to acrylamide. Together, these results both epidemiologically and mechanistically provide strong evidence to unravel the mechanism of acrylamide-triggered anxiety and depression, and highlight the significance of reducing fried food consumption for mental health.

https://www.pnas.org/doi/10.1073/pnas.2221097120