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Wednesday, August 2, 2023

Eyepoint Q2 results and update

 –Phase 2 DAVIO 2 clinical trial evaluating EYP-1901 in wet age-related macular degeneration remains on track to report topline data in December 2023 –

–Phase 2 PAVIA clinical trial evaluating EYP-1901 innon-proliferative diabetic retinopathy remains on track with topline data anticipated in 2Q 2024 –

–Jay S. Duker, M.D. promoted to President and Chief Executive Officer –

–YUTIQ® franchise sold for $82.5 million cash plus future royalties; all outstanding bank debt retired and cash runway extended into 2025 –

–Management to host a conference call and webcast today at 8:30 a.m. ET –


EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the second quarter ended June 30, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI1f9c401d832f439690f47dc2454e01d6. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

Intercept ups guidance after Q2

 

  • Ocaliva® (obeticholic acid or OCA) net sales of $83.7 million, representing 17% growth over the prior year quarter
  • Company updates full-year 2023 Ocaliva net sales guidance to $320 million to $340 million; reiterates non-GAAP adjusted operating expense guidance of $350 million to $370 million
  • Restructuring plan is on track to reduce operating expenses by approximately $140 million
  • Company expects to achieve meaningful profitability in 2024
  • OCA-bezafibrate combination making considerable progress; enrollment of both Phase 2 studies completed; Company expects to have necessary data to submit request in 2023 for End-of-Phase 2 meeting with FDA
  • Company to host conference call today at 8:30 a.m. ET
The conference call and webcast discussing the Company’s second quarter 2023 financial results will take place on August 2, 2023, at 8:30 a.m. ET. The conference call will be available via a listen-only webcast on the investor page of our website at http://ir.interceptpharma.com. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. A replay of the call will be available on our website shortly following the completion of the call and will be available for one year.

Ardelyx Q2 and 2023 IBSRELA Net Sales Revenue Guidance

 Continued successful launch of IBSRELA, with Q2 net sales revenue of $18.3 million; Company currently expects 2023 full year IBSRELA net sales revenue to be $72 to $77 million

XPHOZAH expected to launch in Q4, pending FDA approval

Company ends Q2 with $127.6 million in cash and investments

Conference call scheduled for 8:00 AM Eastern Time

The company will host a conference call today, August 2, 2023, at 8:00 AM ET to discuss these results. To participate in the conference call, please dial (844) 481-2838 (domestic) or (412) 317-1858 (international) and ask to be joined into the Ardelyx call. A webcast of the call can also be accessed by visiting the Investor page of the company's website, www.ardelyx.com, and will be available on the website for 30 days following the call.

https://www.biospace.com/article/releases/ardelyx-reports-second-quarter-2023-financial-results-and-provides-2023-ibsrela-net-sales-revenue-guidance/

Repligen cuts guidance

YEAR 2023 GUIDANCE:

  • Total reported revenue is expected to be in the range of $635-$665 million, compared to our previous guidance of $720-$760 million. This represents a year-over-year decrease of 17%-21%, compared to our previous guidance, a decrease of 5%-10%.  We expect COVID-related revenue of approximately $30 million, compared to our previous guidance of $30-$40 million. For our base business, we are expecting revenues to be down 5%-10%, compared with our previous guidance of a 4%-8% increase.  For the full year, foreign currency impact is expected to be nominal.
  • Gross margin is expected to be 49.5%-50.5% on a GAAP basis, and 50%-51% on a non-GAAP basis, compared to our previous guidance of 52%-53% for both GAAP and non-GAAP.
  • Income from operations is expected to be in the range of $57-$63 million on a GAAP basis, compared to our previous guidance of $111-$116 million. Adjusted (non-GAAP) income from operations is expected to be in the range of $104-$110 million, compared with our previous guidance of $153-$158 million. Adjusted operating margin is expected to be in the range of 16%-17%, compared to our previous guidance of 20.5%-21.5%.
  • Net income is expected to be in the range of $57-$61 million on a GAAP basis, compared to our previous guidance of $97-$101 million. Adjusted (non-GAAP) net income is expected to be in the range of $98-$102 million, compared to our previous guidance of $134-$138 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 $1.00-$1.08 on a fully diluted basis, compared with our previous guidance of $1.70-$1.77. Adjusted net income per share (non-GAAP) is expected to be in the range of $1.72-$1.80 on a fully diluted basis, compared to our previous guidance of $2.35-$2.42.

Teva Q2 profit tops estimates, Huntington's drug sales jump

 Teva Pharmaceutical Industries reported higher than expected second-quarter profit, boosted by a jump in sales of its Austedo treatment for Huntington's Disease.

The world's largest generic drugmaker said on Wednesday it earned 56 cents per diluted share excluding one-time items in the April-June quarter, down from 68 cents per share a year earlier.

Revenue rose 2% to $3.9 billion, with Austedo sales up 51% in North America to $308 million. Migraine treatment Ajovy's sales rose 16% to $57 million.

Analysts had forecast Israel-based Teva would earn 53 cents a share ex-items on revenue of $3.71 billion, I/B/E/S data from Refinitiv Eikon showed.

Sales of generic drugs dipped 6% to $969 million in North America but grew 4% to $909 million in Europe, where Ajovy rose 32%.

Teva expects Austedo sales of some $1.2 billion in 2023, up from $971 million last year. Chief Executive Richard Francis said in May Teva was "going all in" on Auestdo, projecting sales of $2.5 billion by 2027.

"With this solid performance, we are slightly increasing the midpoint of our revenue guidance for the year," Francis said.

"As we remain determined to execute on our growth strategy, we are continuing to focus on our late-stage innovative pipeline delivery and early-stage pipeline development, both organically and through collaborations."

For 2023, Teva revised its revenue forecast to $15.0-$15.4 billion from $14.8-$15.4 billion, after 2022 revenue of $14.9 billion.

It maintained its forecast for adjusted earnings per share of $2.25-$2.55, versus $2.52 in 2022

https://finance.yahoo.com/news/1-teva-pharmaceutical-q2-profit-114041383.html

BeautyHealth’s SkinStylus™ Receives New FDA Clearance for Facial Acne Scarring

 Now the only microneedling device FDA-cleared for use on both the face and abdomen

Milestone achievement in just five months since BeautyHealth’s acquisition of the brand

The Beauty Health Company (NASDAQ:SKIN), home to hero brand Hydrafacial, today announced the U.S. Food and Drug Administration (FDA) has cleared its SkinStylus™ microneedling device for use on facial acne scarring in Fitzpatrick skin types I, II, and III in patients aged 22 years and older, making it the only microneedling device FDA cleared for both the face and abdomen.

https://finance.yahoo.com/news/beautyhealth-skinstylus-receives-fda-clearance-120000179.html

Microsoft…The Truth Is Even Worse Than You Think

Last week, Senator Ron Wyden sent a letter to the Cybersecurity and Infrastructure Security Agency (CISA), the Department of Justice and the Federal Trade Commission (FTC) asking that they hold Microsoft accountable for a repeated pattern of negligent cybersecurity practices, which has enabled Chinese espionage against the United States government. According to data from Google Project Zero, Microsoft products have accounted for an aggregate 42.5% of all zero days discovered since 2014.

Microsoft’s lack of transparency applies to breaches, irresponsible security practices and to vulnerabilities, all of which expose their customers to risks they are deliberately kept in the dark about.

In March 2023, a member of Tenable’s Research team was investigating Microsoft’s Azure platform and related services. The researcher discovered an issue (detailed here) which would enable an unauthenticated attacker to access cross-tenant applications and sensitive data, such as authentication secrets. To give you an idea of how bad this is, our team very quickly discovered authentication secrets to a bank. They were so concerned about the seriousness and the ethics of the issue that we immediately notified Microsoft.  

Did Microsoft quickly fix the issue that could effectively lead to the breach of multiple customers' networks and services? Of course not. They took more than 90 days to implement a partial fix – and only for new applications loaded in the service. 

That means that as of today, the bank I referenced above is still vulnerable, more than 120 days since we reported the issue, as are all of the other organizations that had launched the service prior to the fix. And, to the best of our knowledge, they still have no idea they are at risk and therefore can’t make an informed decision about compensating controls and other risk mitigating actions. Microsoft claims that they will fix the issue by the end of September, four months after we notified them. That’s grossly irresponsible, if not blatantly negligent. We know about the issue, Microsoft knows about the issue, and hopefully threat actors don’t. 

Cloud providers have long espoused the shared responsibility model. That model is irretrievably broken if your cloud vendor doesn’t notify you of issues as they arise and apply fixes openly. 

What you hear from Microsoft is “just trust us,” but what you get back is very little transparency and a culture of toxic obfuscation. How can a CISO, board of directors or executive team believe that Microsoft will do the right thing given the fact patterns and current behaviors? Microsoft’s track record puts us all at risk. And it’s even worse than we thought.

Amit Yoran

Chairman and CEO, Tenable (TENB)

https://www.linkedin.com/pulse/microsoftthe-truth-even-worse-than-you-think-amit-yoran/