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Tuesday, September 17, 2024

===Compass Minerals (CMP) reported earnings on Tue 17 Sept 24 (b/o)

 


Compass Minerals reports solid Q3 results amid accounting review

OVERLAND PARK, Kan. - Compass Minerals (NYSE: CMP), a significant player in the global essential minerals market, disclosed preliminary financial outcomes for its fiscal 2024 third quarter on Tuesday. The company highlighted robust performance in its Salt and Plant Nutrition segments, despite ongoing restatements of past financials due to accounting errors.


According to the preliminary data, Compass Minerals reported revenue of $202.9 million and adjusted EBITDA of $32.8 million for the quarter ending June 30, 2024. Despite a net loss of $43.6 million, or $1.05 per diluted share, the company noted improvements in its core business areas.


Edward C. Dowling Jr., Compass Minerals' President and CEO, acknowledged the delay in disclosing positive results due to historical accounting issues but emphasized the strong performance of the core businesses. Dowling Jr. expressed his commitment to operational excellence, cash generation, and balance sheet deleveraging, aiming for higher shareholder returns.


The financial restatement process, which began with the identification of misstatements in prior quarterly and annual reports, is ongoing. The company is working with auditors to correct these errors, which primarily relate to contingent consideration from the acquisition of Fortress North America, LLC. Although the restatements do not materially affect the company's adjusted EBITDA or the fundamentals of its core businesses, the completion date remains uncertain.


In the Salt segment, Compass Minerals saw a preliminary adjusted EBITDA per ton of $28.05 and increased its mid-point adjusted EBITDA guidance for 2024 by $15 million. The Plant Nutrition segment reported a sequential 2% increase in the average sales price for sulfate of potash to $691.27 per ton, with adjusted EBITDA per ton and margin reaching $128.57 and 18.6%, respectively.


The company also provided updates on the Fortress North America business, which is under review for its future direction, and its liquidity position, ending the quarter with $220.8 million in liquidity.


Looking ahead, Compass Minerals revised its 2024 guidance for both the Salt and Plant Nutrition segments, reflecting adjustments due to lower sales volumes, increased costs, and higher pricing. The company continues to focus on reducing salt inventory levels and converting excess inventory to cash.


This report is based on a press release statement and reflects the preliminary financial results for Compass Minerals' third quarter of fiscal 2024. The company's actual results may differ once the financial restatements are completed and the quarter-end closing procedures are finalized.

In other recent news, Compass Minerals is faced with a New York Stock Exchange compliance issue due to a delay in filing its quarterly financial report. The delay is attributed to necessary restatements of the company's financial statements for several previous quarters. Compass Minerals has received a noncompliance notice but remains committed to regaining compliance swiftly.


There have been significant changes in the leadership team at Compass Minerals. Ashley Ward has been appointed as Vice President, Corporate Controller, and Principal Accounting Officer, while the company announced the immediate resignation of its Chief Operations Officer, Gordon Dunn. Furthermore, Jeffrey Cathey has been named the new Chief Financial Officer.


On the financial front, Compass Minerals reported mixed second-quarter fiscal 2024 results, with decreased sales volumes in its Salt segment due to mild winter weather. However, there was a 9% increase in gross revenue per ton and an 11% increase in net revenue per ton year-over-year. The company has implemented measures such as suspending dividends and temporarily reducing production at its Goderich mine to improve cash flow and reduce debt. Compass Minerals is also exploring strategic alternatives for the Fortress business and has amended its credit facility for covenant relief. These are among the recent developments at Compass Minerals.

==BridgeBio Pharma (BBIO) : Breakthrough Therapy Designation to oral infigratinib

 


BridgeBio Pharma announces that the FDA has granted Breakthrough Therapy Designation to oral infigratinib under development for children with achondroplasia
  • Breakthrough Therapy Designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA's requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s).
  • BridgeBio will leverage the benefits of Breakthrough Therapy Designation to expedite the development and regulatory review of infigratinib in the United States and if approved, infigratinib could be the first-in-class oral therapeutic option for children living with achondroplasia.
  • In Cohort 5 of PROPEL 2 (0.25 mg/kg/day), oral treatment with infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV), with a mean change from baseline of +2.51cm/yr at Month 12, and +2.50 cm/yr at Month 18 (p=0.0015) and statistically significant improvement in body proportionality at Month 18.

Friday, September 13, 2024

===SelectQuote (SLQT) reported earnings on Fri 13 Sept 24 (b/o)

 


OVERLAND PARK, Kan. (AP) — OVERLAND PARK, Kan. (AP) — SelectQuote, Inc. (SLQT) on Friday reported a loss of $31 million in its fiscal fourth quarter.

On a per-share basis, the Overland Park, Kansas-based company said it had a loss of 18 cents.

The company posted revenue of $307.2 million in the period.

For the year, the company reported a loss of $34.1 million, or 20 cents per share. Revenue was reported as $1.32 billion.

SelectQuote expects full-year revenue in the range of $1.4 billion to $1.5 billion.

Thursday, September 12, 2024

Fulcrum Therapeutics (FULC) : Topline Results from Phase 3 REACH Clinical Trial of Losmapimod in Facioscapulohumeral Muscular Dystrophy (FSHD)

Losmapimod failed to show an improvement in relative surface area (RSA), a measure of reachable workspace (RWS), versus placebo at week 48 

― Fulcrum to suspend future losmapimod development 

― Robust cash position enables Fulcrum to continue its mission to develop therapies addressing diseases of high unmet need including pociredir for the treatment of sickle cell disease (SCD)
 
 
 
 
 
 



Fulcrum Therapeutics is a biopharmaceutical company that focuses on developing small molecule therapies to treat rare diseases. The company was founded in Cambridge, Massachusetts in July 2016 by Third Rock Ventures.
It went public on July 17, 2019.

About the REACH Trial
REACH (NCT05397470) is a Phase 3 multi-center, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of losmapimod for the treatment of FSHD. The trial enrolled 260 patients who were randomized 1:1 to receive either losmapimod, administered orally as a 15 mg tablet twice a day, or placebo over a 48-week treatment period. The primary endpoint was the absolute change from baseline in Reachable Workspace (RWS). Secondary endpoint measurements included Muscle Fat Infiltration (MFI) as measured by MRI, shoulder abductor strength as measured by hand-held dynamometry, Patient Global Impression of Change (PGIC), and the Neuro QoL Upper Extremity.

About FSHD
FSHD is a serious, rare, progressive and debilitating disease for which there are no approved treatments. It is characterized by fat infiltration of skeletal muscle leading to muscular atrophy involving primarily the face, scapula and shoulders, upper arms, and abdomen. Impact on patients includes relentless and accumulating muscle and functional loss impacting their ability to perform activities of daily living, loss of upper limb function, loss of mobility and independence, and chronic pain. FSHD is one of the most common forms of muscular dystrophy and has an estimated patient population of 30,000 in the United States alone.