Piper: Potential Shockwave headwinds

 Shockwave Medical Inc SWAV shares are trading lower after the released Q3 earnings.

Q3 revenue was $186.0 million, a 42% increase, beating the consensus of $184.72 million, primarily driven by increased purchase volume of our products in the U.S. and internationally.

The gross margin percentage was 87%, compared to 86% for the three months ended September 30, 2022.

Total operating expenses were $117.9 million, a 54% increase, primarily driven by sales force expansion and higher headcount to support the growth of the business.The company reported Q3 EPS of $0.92, beating the consensus of $0.79.

Adjusted EBITDA improved by approximately 31% to $65.0 million.

Guidance: Shockwave Medical reaffirms FY23 revenue guidance of $725 million-$730 million versus consensus of $728.85 million.

Piper Sandler attributes the falling share price to a top-line beat that fell short of investor expectations, the lack of a guidance raise, and some ongoing concerns related to China and the U.S. peripheral business. 

The analysts Adam Maeder and Simran Kaur acknowledge these headwinds bear monitoring but view these dynamics to likely be transitory, and SWAV’s decision to flag them for investors was prudent. 

Piper reaffirms that SWAV is one of the best assets in the MedTech category—offering investors a unique combination of top-line growth, margins, and profitability at a palatable valuation. 

https://www.benzinga.com/analyst-ratings/analyst-color/23/11/35651535/heart-device-maker-shockwave-medical-is-one-of-the-best-assets-in-medtech-category-

Lumos Topline Data from Phase 2 Trials Met All Primary and Secondary Endpoints

 

• OraGrowtH210 Results Show LUM-201 Dose of 1.6 mg/kg Achieves Annualized Height Velocities (AHV) of 8.2 cm/yr at 6 Months and 8.0 cm/yr at 12 Months, Comparable to Growth Rates for Moderate PGHD Population
• Delta at 6 and 12-month AHV Between Optimal LUM-201 Dose of 1.6 mg/kg and rhGH Comparator Arm is Within the Non-inferiority Margin (< 2 cm/yr) Suggested by FDA for Recent Approvals
• Initial 24-month LUM-201 Data from Combined OraGrowtH210 and OraGrowtH212 Trials Demonstrate a Sustained AHV Effect from Year 1 to Year 2
• Met Pre-specified Primary Endpoint of Validation of Predictive Enrichment Marker (PEM) Test and Secondary Endpoint Demonstrating 100% Reproducibility of PEM-Positive Classification
• OraGrowtH212 Demonstrated That, with Only 20% the GH Concentration of Injectable rhGH, LUM-201 Achieved Expected AHV While Demonstrating the Unique Pulsatile Mechanism of Action of LUM-201††
• No Safety Signal to Date for LUM-201

Company to Host Conference Call Tomorrow Morning at 8:30AM ET

Conference Call and Webcast Details

Date: November 8, 2023
Time: 8:30 AM ET
Dial-in: 1-877-407-9716 or 1-201-493-6779 (international)
Conference ID: 13742617
Or Dial-in registration (Available 15 minutes prior to scheduled start time): https://callme.viavid.com/viavid/?callme=true&passcode=13742617&h=true&info=company-email&r=true&B=6
Webcast link: https://viavid.webcasts.com/starthere.jsp?ei=1642841&tp_key=d9efda8a69

https://www.globenewswire.com/news-release/2023/11/07/2775552/15114/en/Lumos-Pharma-Announces-Topline-Data-from-Phase-2-OraGrowtH210-and-OraGrowtH212-Trials-of-LUM-201-in-PGHD-Met-All-Primary-and-Secondary-Endpoints.html

Gilead, Arcus: Encouraging Data in First-Line Treatment for Upper GI Cancers

 Preliminary data from Arm A1 of the Phase 2 EDGE-Gastric study showed promising ORR and six-month PFS results, irrespective of PD-L1 expression –

– Domvanalimab is the only Fc-silent anti-TIGIT antibody in Phase 3 for upper GI adenocarcinomas and has the potential to be first to market for these cancers –

– Detailed results will be presented on November 7 at 12pm PT / 3pm ET during the ASCO Monthly Plenary Series –

https://www.businesswire.com/news/home/20231106343567/en/

Gilead Squashes Expectations On Back Of Bullish Move For Cancer Drugs

 Gilead Sciences (GILD) crushed Wall Street's sales forecasts Tuesday on the back of another quarter of double-digit growth for its cancer treatments. However, GILD stock was muted following the report.

Oncology sales surged 33% to $769 million, well above expectations for $718 million, according to FactSet. The best growth came from breast and bladder cancer treatment, Trodelvy. Trodelvy sales skyrocketed more than 57% to $283 million.

"Gilead has now delivered two years of consistent growth in our base business," Chief Executive Daniel O'Day said in a statement. "In this third quarter, continued growth was driven by both virology and oncology."

Overall, third-quarter sales were flat year over year at $7.05 billion. But that smashed forecasts for $6.33 billion. Adjusted earnings came in at $2.29 per share. Earnings advanced 20.5% and walloped GILD stock analysts' expectations for $1.79.

Excluding the impact of Covid treatment, Veklury, Gilead's product sales climbed 5%.

Beyond cancer drugs, sales of treatments for hepatitis collectively tumbled 10% to $706 million. Meanwhile, Veklury brought in $636 million in sales, diving 31%. GILD stock analysts forecasts just $301 million in sales of Veklury.

On a bright note, revenue from HIV treatments inched up 4% to $4.67 billion, led by Biktarvy. Biktarvy generated two-thirds of HIV treatment sales and grew 11.5% to $3.09 billion. Analysts following GILD stock expected just $2.86 billion in sales from Biktarvy.

Gilead raised its outlook for the year and now expects $26.7 billion to $26.9 billion in product sales, which exclude licensing and other sources of revenue. Gilead also expects Veklury to generate $1.9 billion in sales, up from the guidance it issued three months ago for $1.7 billion.

Further, the company expects to earn $6.65 to $6.85 per share, on an adjusted basis.

GILD stock analysts forecasted $25.03 billion in total revenue and $24.81 billion in product sales. They expected Veklury to bring in $1.57 billion in sales. The Street also forecasts adjusted profit of $6.17 per share.

https://www.investors.com/news/technology/gild-stock-gilead-wallops-earnings-views-on-the-back-of-strong-cancer-drugs/

Senti 'strategic collaboration in Cina'

 Senti Biosciences (NASDAQ:SNTI) stock is rocketing higher on Tuesday after the company announced a new strategic collaboration in China.

This strategic collaboration has the biotechnology company agreeing to work with Celest Therapeutics. The two will handle the clinical development of SENTI-301A as a treatment for solid tumors in the country.

This collaboration will have Celest Therapeutics handling the major clinical development of the treatment. That includes manufacturing of SENTI-301A in China. Senti Biosciences will act in a support role to the company with its technical expertise.

With this agreement, Senti Biosciences is eligible to receive up to $156 million in milestone payments from Celest Therapeutics. Terms of the deal also include tiered royalty payments for the company. Adding to that, SNTI retains the right to commercialize SENTI-301A outside of mainland China, Hong Kong, Macau, and Taiwan.

Timothy Lu, MD, PhD, co-founder and CEO of Senti Biosciences, said the following about the collaboration:

“By leveraging Celest’s strength to accelerate clinical development, manufacturing, and regulatory activities in China, we are one step closer to bringing Senti’s Gene Circuit technology to patients who have limited therapeutic options.”

With today’s news comes heavy trading of SNTI stock. As of this writing, more than 8.7 million shares of the stock have changed hands. For the record, the company’s daily average trading volume is closer to 396,000 shares.

https://investorplace.com/2023/11/why-is-senti-biosciences-snti-stock-up-140-today/

TransMedics shares pop after organ-transplant company's 'blockbuster' results

 Company boosts full-year sales outlook as it launches transplant-aviation business

TransMedics Group Inc. shares (TMDX) jumped more than 40% premarket on Tuesday after the company reported third-quarter results reflecting growing demand for its organ-transplant services and raised its full-year revenue outlook.

The company late Monday reported a net loss of $25.42 million, or 78 cents per share, compared with a loss of $7.43 million, or 25 cents per share, in the year-earlier period. The FactSet consensus was a loss of 16 cents per share. Revenue totaled $66.43 million, up from $25.68 million and ahead of the FactSet consensus of $49.2 million.

TransMedics raised its full-year sales guidance to a range of $222 million to $230 million, up from prior guidance of $180 million to $190 million.

Sales growth was driven by increasing demand for the company's Organ Care System products, which use a technology designed to better preserve and assess donor organs and reduce the number of unused organs, according to TransMedics. The system, which focuses on lung, heart and liver transplants, maintains the organs in a living, functioning state.

The net loss in the quarter was driven primarily by $29.2 million in acquisition-related costs, TransMedics said. The company recently closed its acquisition of Summit Aviation as it prepares to launch a new transplant aviation business.

Oppenheimer analysts on Tuesday called the results a "blockbuster" quarter for TransMedics, saying the company's strategy of offering an organ-transplant logistics and service one-stop shop, "while bumpy short-term, should yield dividends long-term." The company's organ-care system, the analysts wrote, "represents a disruptive technology that could potentially revolutionize solid organ preservation and transport" by narrowing the gap between demand and supply of donor organs and expanding the pool of usable organs.

More than 100,000 people in the U.S. are on the national transplant waiting list, according to federal government data.

TransMedics shares are down 35% in the year to date, while the S&P 500 has gained 13.7%.

https://www.morningstar.com/news/marketwatch/20231107121/transmedics-stock-pops-after-organ-transplant-companys-blockbuster-third-quarter-results

PaxMedica up on autism trial

 PaxMedica (NASDAQ:PXMD) stock is rising higher on Tuesday as investors celebrate the company’s publication of Phase 2 clinical trial results.

The study was published in the Annals of General Psychiatry and focused on the use of low-dose suramin intravenous infusions as a treatment for Autism Spectrum Disorder (ASD). The study was double-blind and placebo-controlled and lasted for 14 weeks, with the patients being boys ranging in age from four to 15 years.

The results from the study showed positive results in the 10 mg/kg suramin dosage. That includes significant improvements in the Clinical Global Impressions-Improvement scale when compared to the group taking a placebo.

Investors are excited about the potential for PaxMedica to treat symptoms of ASD. That has resulted in heavy trading of PXMD stock on Tuesday, with some 23 million shares changing hands. For the record, its daily average trading volume is closer to 141,000 shares.

https://investorplace.com/2023/11/why-is-paxmedica-pxmd-stock-up-95-today/