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Wednesday, November 8, 2023
Ventyx cut at 5 sell siders
Samsung Bioepis, Organon Application (sBLA) Accepted for Biosimilar to Humira
- sBLA based on Phase 4 study which assessed pharmacokinetic similarity between two treatment groups: multi-switching group alternating between Humira and high-concentration HADLIMA vs. Humira-continued group
- Filing acceptance reinforces Samsung Bioepis and Organon’s commitment to provide better access to biologic medicines for patients in the United States
Beam updates portfolio, operating highlights
Recent Portfolio Prioritization Focuses Business on Key Near-term Value Drivers and Long-term Growth of Precision Genetic Medicines Pipeline
Lilly Acquires Beam’s Opt-In Rights to Verve Therapeutics’ Base Editing Cardiovascular Programs for up to $600 Million in Combined Upfront Payment, Equity Investment and Potential Future Development-Stage Payments
GMP Operations Initiated at Beam's North Carolina Manufacturing Facility
Strong Balance Sheet Provides Anticipated Operating Runway into the Second Half of 2026
Amicus ups revenue guidance
3Q 2023 Total Revenue of $103.5M, a 27% Increase Year-Over-Year and 22% at CER
Galafold® Quarterly Revenue Surpasses $100M for the First Time
Increasing FY 2023 Galafold® Revenue Growth Guidance to 16%-18% at CER
Pombiliti™ + Opfolda™ Approved and Launched in the U.S., EU, and U.K.
Non-GAAP Profitability Projected in Q4 2023
Conference Call and Webcast Today at 8:30 a.m. ET
2023 Financial Guidance
- For the full-year 2023, the Company is increasing the Galafold revenue growth guidance to between 16 and 18% at CER1 driven by several factors including continued strong underlying demand from both switch and treatment-naïve patients, further geographic expansion and label extensions, the continued diagnosis of new Fabry patients, and commercial execution across all major markets, including the U.S., EU, U.K., and Japan.
- Non-GAAP operating expense guidance for the full-year 2023 is $330 million to $350 million, driven by prudent expense management offset by continued investment in Galafold, AT-GAA clinical studies, non-recurring costs for manufacturing as well as global launch activities4.
- The Company is on-track to achieve non-GAAP profitability2 in the fourth quarter of 2023.
Amicus is focused on the following five key strategic priorities in 2023:
- Sustain double-digit Galafold revenue growth (16-18% at CER1)
- Secure EMA, MHRA, and FDA approvals for Pombiliti + Opfolda
- Initiate successful global launches of Pombiliti + Opfolda
- Advance next-generation pipeline programs (Fabry GTx, Fabry Next-Generation Chaperone, Pompe GTx)
- Maintain strong financial position on path to profitability
Conference Call and Webcast
Amicus Therapeutics will host a conference call and audio webcast today, November 8, 2023, at 8:30 a.m. ET to discuss the third quarter 2023 financial results and corporate updates. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a personal PIN to access the event.
A live audio webcast and related presentation materials can also be accessed via the Investors section of the Amicus Therapeutics corporate website at ir.amicusrx.com. Web participants are encouraged to register on the website 15 minutes prior to the start of the call. An archived webcast and accompanying slides will be available on the Company's website shortly after the conclusion of the live event.
Biogen cuts annual profit forecast as higher costs persist
Biogen on Wednesday cut its annual profit forecast, which slipped below Wall Street expectations, due to rising costs from the recent acquisition of Reata Pharmaceuticals and the launch of its Alzheimer's treatment Leqembi.
To drive future growth, the drugmaker is leaning on newer products including Leqembi, postpartum depression drug Zurzuvae and the rare disease treatments acquired through its $6.5 billion buyout of Reata.
The costs associated with the deal, however, pushed up Biogen's costs and expenses to $2.67 billion, more than double from a year ago.
Still, the company beat market expectations for profit in the third quarter, helped by strong sales for its rare muscle-wasting disorder drug Spinraza, sending its shares up about 1.4% in premarket trading.
"We now have the elements to grow sustainably so our focus is no longer on doing anything of significance in M&A at least for the time being," CEO Christopher Viehbacher said on a media call.
Since he was hired a year ago, Viehbacher has led efforts to cut expenses and help Biogen recover from its missteps around the controversial Alzheimer's drug Aduhelm that never gained traction.
Spinraza sales of $448.2 million beat estimates of $433 million for the quarter.
The drugmaker expects full-year adjusted profit per share in the range of $14.50 to $15.00 compared with $15 to $16 forecast previously. Analysts were expecting $15.26.
On an adjusted basis, Biogen earned $4.36 per share, beating analysts' average estimate of $3.97, according to LSEG data.
https://finance.yahoo.com/news/biogen-cuts-annual-profit-forecast-120304410.html
Tuesday, November 7, 2023
ADC Therapeutics results after restructuring
- 3Q 2023 ZYNLONTA®1 net sales of $14.3 million reflect disruption following restructuring of commercial organization, increased competition and higher gross-to-net deductions
- Operating expenses decreased 23%2 year-over-yeardue to portfolio prioritization and operational efficiencies; Expected cash runway into mid-2025
- Prioritized pipeline progressing with initial data readouts from LOTIS-7 and studies of ADCT-601 targeting AXL and ADCT-901 targeting KAAG1 expected in 1H 2024
- Company to host conference call today at 8:30 a.m
Conference Call Details
ADC Therapeutics management will host a conference call and live audio webcast to discuss third quarter 2023 financial results and provide a company update today at 8:30 a.m. Eastern Time. To access the conference call, please register here. Registrants will receive the dial-in number and unique PIN. It is recommended that you join 10 minutes before the event, though you may pre-register at any time. A live webcast of the call will be available under “Events & Presentations” in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com. The archived webcast will be available for 30 days following the call.
Arvinas Q3 Business Update
- Enrollment continues in the 2L Phase 3 VERITAC-2 trial and study lead-in for the VERITAC-3 1L Phase 3 trial with vepdegestrant; Top-line data readout for VERITAC-2 remains on-track for 2H 2024
- Bavdegalutamide mCRPC data presented at ESMO showed median rPFS of 11.1 months in patients with AR 878/875 tumor mutations, demonstrating the potential for a PROTAC® AR degrader in prostate cancer
- New interim data from second generation PROTAC AR degrader support the Company’s decision to prioritize the initiation of a Phase 3 trial with ARV-766 in mCRPC instead of the previously planned Phase 3 trial for bavdegalutamide
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