Target to $148 from $166
Tuesday, May 2, 2023
Regional Banks Crashing
Weak JOLTS?, Poor factory orders, hot EU inflation, surprise RBA rate-hike, a sudden realization of the urgency and seriousness of the debt ceiling debacle, Europe back from vacation, or just pre-FOMC jitters?
Or was it this!?
Repligen cuts guidance
Our financial guidance for the fiscal year 2023 is based on expectations for our existing business. This guidance includes the impact of our FlexBiosys acquisition and excludes the impact of potential additional acquisitions, and future fluctuations in foreign currency exchange rates.
YEAR 2023 GUIDANCE:
Total reported revenue is expected to be in the range of $720-$760 million, a 5% downward adjustment to our previous guidance of $760-$800 million. We continue to expect COVID-related revenue to be in the range of $30-$40 million. For our base business, we are expecting growth of 4%-8% as reported and at constant currency, compared with our previous guidance of 11%-15% as reported and 12%-16% at constant currency.
Gross margin is expected to be 52%-53% on both a GAAP and non-GAAP basis, an adjustment from our previous guidance of 52.5%-53.5%.
Income from operations is expected to be in the range of $111-$116 million on a GAAP basis, compared to our previous guidance of $135-$141 million. Adjusted (non-GAAP) income from operations is expected to be in the range of $153-$158 million, compared with our previous guidance of $176-$182 million. Adjusted operating margin is expected to be in the range of 20.5%-21.5%, compared to our previous guidance of 22.5%-23.5%.
Net income is expected to be in the range of $97-$101 million on a GAAP basis, compared to our previous guidance of $112-$117 million. Adjusted (non-GAAP) net income is expected to be in the range of $134-$138 million, compared to our previous guidance of $149-$154 million. This reflects a tax rate of 20% on adjusted pre-tax income, consistent with our previous guidance.
Net income per share (GAAP) is expected to be in the range of $1.70-$1.77 on a fully diluted basis, compared with our previous guidance of $1.96-$2.04. Adjusted net income per share (non-GAAP) is expected to be in the range of $2.35-$2.42 on a fully diluted basis, compared to our previous guidance of $2.61-$2.69.
Our non-GAAP guidance for the fiscal year 2023 excludes the following items:
$2.8 million estimated acquisition and integration expenses in SG&A.
$30.1 million estimated intangible amortization expense in SG&A.
$1.8 million in amortization of debt issuance expense (Other income (expense)).
$8.7 million estimated contingent consideration expense related to our Avitide acquisition and estimates for time value of money implications.
Our non-GAAP guidance for the fiscal year 2023 includes:
An income tax increase of $6.3 million, representing the tax impact on acquisition and integration costs, intangible amortization and contingent consideration expense, and amortization of debt issuance costs.
Repligen will host a conference call and webcast today, May 2, 2023, at 8:30 a.m. ET, to discuss first quarter 2023 financial results, corporate developments and financial guidance for the year 2023. The conference call will be accessible by dialing toll-free (844) 274-3999 for domestic callers or (412) 317-5607 for international callers. No passcode is required for the live call. In addition, a webcast will be accessible via the Investor Relations section of the Company’s website. Both the conference call and webcast will be archived for a period of time following the live event. The replay dial-in numbers are (877) 344-7529 from the U.S., (855) 669-9658 from Canada and (412) 317-0088 for international callers. Replay listeners must provide the passcode 1872405.
Tenaya fast tracked for gene therapy candidate
TN-201 Being Developed for the Potential Treatment of MYBPC3-associated HCM
Dosing in Phase 1 Clinical Trial Expected to Commence in Q3 2023
Tenaya Therapeutics, Inc. (NASDAQ: TNYA), a clinical-stage biotechnology company with a mission to discover, develop and deliver potentially curative therapies that address the underlying causes of heart disease, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for its gene therapy product candidate, TN-201, being developed for the treatment of Myosin Binding Protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM).
TN-201 is Tenaya’s potential first-in-class adeno-associated virus (AAV)-based investigational gene therapy for the treatment of HCM caused by mutations in the MYBPC3 gene, the most common genetic cause of HCM. TN-201 is designed to deliver a fully functional MYBPC3 gene to restore normal levels of myosin-binding protein, which regulates the contraction and relaxation of the heart muscle. In preclinical studies of MYBPC3 knock-out models, TN-201 has been shown to halt disease progression and demonstrated significant and durable disease reversal and survival benefit after a single dose.
https://finance.yahoo.com/news/tenaya-therapeutics-receives-fda-fast-115000395.html
Kiniksa: First Quarter 2023 Financial Results and Recent Portfolio Execution
– ARCALYST® (rilonacept) Q1 2023 net product revenue of $42.7 million –
– ARCALYST full-year 2023 net product revenue guidance increased to $200 - $215 million, representing ~69% year-over-year growth at the midpoint –– Final cohort of KPL-404 Phase 2 rheumatoid arthritis trial now enrolling patients; data expected in 1H 2024 –
– Cash reserves now expected to fund operations into at least 2026 –
– Conference call and webcast scheduled for 8:30 am ET today –
Conference Call Information
Kiniksa will host a conference call and webcast at 8:30 a.m. Eastern Time on Tuesday, May 2, 2023 to discuss first quarter 2023 financial results and recent portfolio execution.
Individuals interested in participating in the call via telephone may register here. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. To access the webcast, please visit the Investors and Media section of Kiniksa’s website. A replay of the event will also be available on Kiniksa’s website within approximately 48 hours after the event.
Vivani eyes subdermal drug delivery implant to diabetes market
When Second Sight Medical and Nano Precision Medical merged last year, the rebranded company — Vivani Medical (Nasdaq:VANI)— had a goal: bring a six-month, subdermal drug delivery implant that treats conditions including type 2 diabetes to market.
CEO Dr. Adam Mendelsohn leads the way for the developer of the proprietary NanoPortal technology. His experience in drug delivery and diabetes technology goes back to his high school days.
Mendelsohn first interned at insulin pump maker MiniMed, which Medtronic eventually acquired. He moved on to a company developing implantable morphine delivery pumps for pain management. Boston Scientific ultimately acquired that company.
Then came PhD work on transplanting pancreatic beta cells that could produce insulin for patients with type 1 diabetes.
Mendelsohn co-founded Nano Precision Medical in 2009 and has been in charge as CEO since then. Along what he calls his “incredible journey,” the company has moved closer to bringing its innovative technology to the diabetes space.
“We’re really excited about the opportunity to improve medication adherence, which we think is one of the biggest challenges facing chronic disease patient outcomes,” Mendelsohn told Drug Delivery Business News. “It can be addressed very squarely with the technology that we’re developing.”
NanoPortal technology
Vivani designed its proprietary NanoPortal implant technology to steadily deliver medication over extended periods of time.
The company aims to guarantee correct doses for patients while avoiding potential safety concerns around fluctuating drug release profiles. The technology can also deliver large hydrophilic molecules, including peptides and proteins. The company believes this enables a broader range of therapeutic applications.
Vivani’s targeted conditions for this technology include type 2 diabetes, non-alcoholic steatohepatitis (NASH) and obesity.
The company’s lead product candidate, NPM-119, is a drug-device combination for diabetes treatment. The miniature, subdermal implant is placed in a patient by a healthcare professional during an outpatient procedure. For up to six months, it can provide steady doses of exenatide.
The GLP-1 receptor agonist helps the patient produce more insulin when blood sugar levels are high. However, if levels are normal or low, it does not increase insulin production, avoiding the risk of hypoglycemia associated with insulin over-delivery.
Delivery through the NanoPortal technology will hopefully free patients from the hassles of daily pills or weekly injections.
“Once every six months, you go in, you get your implant as part of your normal visit,” Mendelsohn said. “In between visits, the patient and the caregiver can be confident that their patient is getting at least their GLP-1 medicine during that time. Maybe there are other medicines they have to remember, but it will reduce the overall treatment burden and — we think — have a compelling effect on patient outcomes, in addition to a compelling effect on healthcare costs.”
Learning from Intarcia story
Intarcia Therapeutics was at one point seen as a potential game-changer in diabetes. The company was developing a type 2 diabetes drug and a proprietary implant for delivery. Mendelsohn said that the six-month GLP-1-delivering implant was about twice the diameter and length of Vivani’s.
Intarcia was once valued at more than $5 billion by investors. But despite the hype, the FDA refused to allow Intarcia’s ITCA 650 on the market. Trials identified that it might cause acute kidney issues. There were also some production challenges.
Intarcia received a lifeline last month when the FDA allowed it to request a public advisory committee hearing after two previous rejections. Mendelsohn said that development was exciting as Vivani aims to make its own dent in the market.
Among the advantages Mendelsohn said the company may have over Intarcia’s offering are the smaller size of the implant and its needle and steady release rate.
“We’ve seen the world really support the development of a six-month exenatide implant,” he said. “There are no fluctuations. We’ve been able to measure at time scales of two-and-a-half hours and show that the release rate doesn’t change. That is one of the critical differentiators and advantages and the reason why we are optimistic that, even if Intarcia doesn’t end up succeeding, we have a path to approval with this product.”
Vivani’s future plans include a Phase 2 study of patients with type 2 diabetes on GLP-1 treatment. The company expects the trial to compare patients switched to its implants with Bristol Myers Squibb’s Bydureon once-weekly exenatide injection.
This trial can help understand day-to-day fluctuations in pharmacokinetics. That could represent an important aspect potentially allowing Vivani to pursue the FDA 505 (b)(2) pathway to avoid a pre-approval outcomes study.
https://www.drugdeliverybusiness.com/vivani-medical-subdermal-drug-delivery-implant-diabetes/
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