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Friday, August 11, 2023

Inotiv FQ3 misses

 Q3 FY 2023 Highlights

  • Revenue was $157.5 million in Q3 FY 2023 as compared to $172.7 million during the three months ended June 30, 2022 (“Q3 FY 2022”), driven by a $2.4 million, or 5.0%, decrease in Discovery and Safety Assessment (“DSA”) revenue and a $12.7 million, or 10.3%, decrease in Research Models and Services (“RMS”) revenue.

  • Consolidated net income for Q3 FY 2023 was $0.4 million, or 0.2% of total revenue, compared to consolidated net loss of $(3.6) million, or (2.1%) of total revenue, in Q3 FY 2022.

  • Adjusted EBITDA1 was $30.5 million, or 19.4% of total revenue, compared to $37.0 million, or 21.4% of total revenue, in Q3 FY 2022.

  • Net book-to-bill ratio was 1.08x for the DSA services business.

  • DSA backlog was $149.1 million, up from $143.2 million at June 30, 2022.

YTD FY 2023 Highlights

  • Revenue grew to $431.7 million in YTD FY 2023 from $397.2 million during the nine months ended June 30, 2022 (“YTD FY 2022”), driven by a $13.8 million, or 11.4%, increase in DSA revenue and a $20.7 million, or 7.5%, increase in RMS revenue.

  • Consolidated net loss for YTD FY 2023 was $(96.2) million, or (22.3)% of total revenue, compared to consolidated net loss of $(93.6) million, or (23.6)% of total revenue, in YTD FY 2022. The YTD FY 2023 consolidated net loss included a $66.4 million non-cash goodwill impairment charge related to our RMS segment. The YTD FY 2022 consolidated net loss included one-time charges of $56.7 million of fair value remeasurement of the embedded derivative component of the convertible notes issued in September 2021 and $23.0 million of post combination stock compensation expense relating to the adoption of the Envigo Equity Plan.

  • Adjusted EBITDA1 was $42.1 million, or 9.8% of total revenue, compared to $72.2 million, or 18.2% of total revenue, in YTD FY 2022.

  • Net book-to-bill ratio was 1.01x for the DSA services business.

DSA and RMS Highlights

  • The Company previously announced several site optimization initiatives which it was able to complete as planned as of June 30, 2023. The Company continues to execute on its site optimization plan for its Blackthorn, UK site. The relocation of operating activities from Blackthorn into its Hillcrest, UK site is expected to be completed by the end of the third quarter of fiscal 2024.

  • The expansion activities at Fort Collins, CO, remain on track and are expected to become operational in the early part of the first quarter of fiscal 2024.

  • On May 4, 2023, the Company announced the expansion of its safety pharmacology offering with the validation and verification of a cardiopulmonary telemetry study model in cynomolgus macaques. Offered through Inotiv’s DSA business, telemetry allows for the continuous observation of ECG, respiratory rate and volume, blood pressure and other cardiovascular parameters during preclinical safety studies.

  • Envigo RMS, LLC (“Envigo RMS”) is a defendant in a purported class action and a related action under California’s Private Attorney General Act of 2004. On June 2, 2023, Envigo RMS and the plaintiff signed a Memorandum of Understanding (“MOU”) that sets forth the parties’ intent to settle these matters for $0.8 million which includes attorneys’ fees. The MOU provides that the parties will negotiate and enter into a definitive settlement agreement, which will be subject to court approval. The MOU contains no admission of liability or wrongdoing by Envigo RMS. The MOU provides that, if the settlement is approved by the court, the settlement amount would be paid in four quarterly installments, with the first one to be funded after the court’s final approval of the settlement, and the following ones in the three subsequent quarters. This settlement amount is fully accrued for in the third quarter results.

  • The Company's facilities in Cumberland, Haslett and Boyertown, as well as its Israeli business, continue to be held for sale as of June 30, 2023. Additionally, the Israeli business along with the Cumberland and Boyertown facilities remain under contract as of June 30, 2023. Furthermore, the Company's Haslett, Michigan, Gannat, France and Blackthorn, U.K. facilities are available for sale as of June 30, 2023.

  • Management Commentary

Robert Leasure Jr., President and Chief Executive Officer, commented, “We are pleased with a solid third quarter as we diligently work towards completing the final stages of many integration projects, optimizing our infrastructure and right-sizing the Company’s global footprint. In addition, we have adapted in response to the industry challenges related to importation of NHPs this fiscal year. Looking ahead, we are preparing the Company for its next chapter of profitability, continuing to improve the client experience and building a Company that can enhance long term value for our shareholders and employees. We are competitively positioning Inotiv as a leading mid-sized full-service CRO and research model and diet provider."

"As we completed the majority of our anticipated closures and consolidations this quarter, we feel we have set a foundation that will allow us to increasingly focus on operations, growth and drive towards improved profitability. As such, we expect to realize margin and earnings improvements as we fully optimize and integrate our DSA and RMS segments. Building on this, we look forward to growing organically as well as developing new business opportunities and are confident in our abilities to compete with smaller as well as larger CRO and research model providers, alike," concluded Mr. Leasure.

Subsequent Events

  • In July 2023, the Company made the decision to close its Spain facility. This is now completed, and the Spain facility is now for sale.

  • The Company will also be closing its Everett, WA facility and relocating these operations to Fort Collins, CO upon the completion of the Fort Collins, CO expansion in fiscal Q1 2024. The Everett lease expires November 30, 2023.

Management will host a conference call on Thursday, August 10, 2023, at 4:30 pm ET to discuss third quarter results for fiscal year 2023.

Interested parties may participate in the call by dialing:

  • (888) 886-7786 (Domestic)

  • (416) 764-8658 (International)

  • 82963822 (Conference ID)

The live conference call webcast will be accessible in the Investors section of the Company’s web site and directly via the following link:

https://viavid.webcasts.com/starthere.jsp?ei=1626625&tp_key=48ebb7e73b

For those who cannot listen to the live broadcast, an online replay will be available in the Investors section of Inotiv’s web site at: https://www.inotivco.com/investors/investor-information/.

https://finance.yahoo.com/news/inotiv-reports-third-quarter-financial-200800043.html

Eton Pharma Q2 beats

 

  • Total Q2 revenue of $12.0 million and net income of $4.6 million

  • Product sales and royalty revenue of $6.5 million up 175% from Q2 2022 and 22% from Q1 2023

  • $21.6 million of cash on hand

  • Launched Betaine Anhydrous

  • Management to hold conference call today at 4:30pm ET

Eton will host its second quarter 2023 conference call as follows:

Date:
Time:
Register* (Audio Only)

Thursday, August 10, 2023
4:30 p.m. ET (3:30 p.m.CT)
Click here

 

 

 

In addition to taking live questions from participants on the conference call, management will be answering emailed questions from investors. Investors can email questions to: investorrelations@etonpharma.com.

The live webcast can be accessed on the Investors section of Eton’s website at https://ir.etonpharma.com/. An archived webcast will be available on Eton’s website approximately two hours after the completion of the event and for 30 days thereafter.

* Conference call participants should register to obtain their dial-in and passcode details. Please be sure to register using a valid email address.

https://finance.yahoo.com/news/eton-pharmaceuticals-reports-second-quarter-200100308.html

Oric: Q2, pre-ESMO updates

 Initial Phase 1b clinical data for ORIC-114 in EGFR/HER2-mutated cancers to be presented at the ESMO Congress being held October 20-24, 2023

Initial Phase 1b clinical data expected for ORIC-533 in multiple myeloma in fourth quarter of 2023 and ORIC-944 in prostate cancer in first quarter of 2024

Strengthened cash position with private placement financing and ended the quarter with cash and investments of $273.7 million which is expected to fund operating plan into late 2025

https://finance.yahoo.com/news/oric-pharmaceuticals-reports-second-quarter-200500053.html

Akero: Q2 updates

Positive Results from Phase 2b SYMMETRY Cohort D, an expansion cohort of Type 2 diabetic, pre-cirrhotic NASH patients treated with EFX or placebo in combination with a GLP-1 receptor agonist, reported during the second quarter of 2023 --

-- Phase 3 SYNCHRONY studies on track to begin enrolling in the second half of 2023 --

-- 36 Weeks Results from the Phase 2b SYMMETRY study, evaluating treatment of patients with compensated cirrhosis due to NASH, on track to be reported in the fourth quarter of this year --

-- $334.8 million in net proceeds raised through Akero’s ATM Facility and underwritten registered direct offering of common stock --

https://finance.yahoo.com/news/akero-therapeutics-reports-second-quarter-100000378.html

Biotricity: 'Growth and Strength in its Fundamentals on its Path to Profitability'

 Company to report robust performance improvements in its operating metrics

  • Record Q1-FY2024 recurring revenue growth

  • Significantly higher margins on technology fees compared to blended margins

  • Strong control over sales and technology expenses through automation and AI

Growing Number Of Leprosy Cases Reported After COVID-19 Vaccination

 by Zachary Stieber via The Epoch Times (emphasis ours),

A growing number of leprosy cases are being reported after COVID-19 vaccination, including two cases in the United Kingdom that researchers said may have been caused by the vaccines.

The researchers examined records from the Leprosy Clinic at the Hospital for Tropical Diseases in London. They found that of the 52 people who went to the clinic in 2021, at least 49 were vaccinated.

The study definition of a leprosy adverse event associated with a COVID-19 vaccine included developing leprosy or a leprosy reaction within 12 weeks of receiving a dose and the person having no previous history of leprosy or a leprosy reaction.

Two people met the case definition. One developed borderline tuberculoid (BT) leprosy one week after a second dose. The other experienced a reaction 56 days after a dose. Both doses were Pfizer’s BNT162b2 vaccine. Pfizer did not respond to a request for comment.

“The development of BT leprosy and a Type 1 reaction in another individual shortly after a dose of BNT162b2 vaccine may be associated with vaccine mediated T cell responses,” the researchers said.

The COVID-19 vaccines can provoke a response from white blood cells, or T cells. The cells are believed to protect against COVID-19.

T-cells can theoretically trigger Mycobacterium leprae, a bacteria that causes leprosy, leading to leprosy or a leprosy reaction, the researchers said.

Other vaccines have been shown to trigger leprosy or leprosy reactions, including tuberculosis vaccines, and some people who receive repeated COVID-19 vaccinations have been shown to have weakened immune systems.

The paper was published on Aug. 4 by PLOS Neglected Tropical Diseases.

More on Findings

The person diagnosed with leprosy is an 80-year-old man who has lived in the United Kingdom for 49 years. He suffered from symptoms including thickened nerves. The leprosy diagnosis was confirmed via skin biopsy. The man may be the first to acquire leprosy in the UK since 1954.

The man improved over time and actually received a third dose of Pfizer’s vaccine.

“Interestingly he had a third dose of BNT162b2 vaccine six months after the second dose having started anti-bacterial therapy and experienced no deterioration of his leprosy. The skin lesions and nerve thickening had resolved by the time he completed the six-month course of anti-microbial therapy. There had been no recurrence of the plaques or nerve signs after 12 months,” the researchers said.

The reaction was recorded in a 27-year-old man who had taken multidrug therapy, a drug for leprosy, in the past. He developed red plaques and thickened nerves before arriving in the UK from an unidentified country. A biopsy supported the diagnosis. He took medicine and the symptoms improved.

The link between the vaccine and the issue in the second case was strengthened by studies showing people who took the therapy three years or more years before are unlikely to experience a new reaction, the researchers said.

Of the 52 people who went to the Leprosy Clinic for diagnosis and/or treatment in 2021, all but two reported their vaccination status. Of those 50, 49 were vaccinated.

Five of the patients at the clinic were newly diagnosed with leprosy in 2021. Five others had a type one reaction. All were vaccinated, but just one of each category was determined to be possibly caused by a vaccine after being diagnosed within 12 weeks of vaccination. It was not clear when the other four were vaccinated.

Dr. Barbara de Barros, the study’s corresponding author, did not respond to a request for comment. The authors reported no funding or competing interests.

Dr. de Barros and the other UK researchers said that doctors should be aware that COVID-19 vaccination may cause leprosy but that they believe the benefits of COVID-19 vaccination “outweigh these unwanted events.” They provided no citations for the benefits of vaccination, which have dropped dramatically as newer variants have emerged and led to more nuanced recommendations in some countries. Citations for scope of harm included a 2021 recommendation from India that people with leprosy receive a COVID-19 vaccine.

https://www.zerohedge.com/medical/growing-number-leprosy-cases-reported-after-covid-19-vaccination

Medical Properties Trust cut to Underperform from Strong Buy by Raymond James

 to Underperform from Neutral by B of A; target to $8 from $9

https://finviz.com/quote.ashx?t=MPW&p=d