The following is a summary of the Arrowhead Pharmaceuticals, Inc. (ARWR) Q2 2024 Earnings Call Transcript:
Financial Performance:
Arrowhead Pharmaceuticals reported a net loss of $125.3 million or $1.02 per share for the quarter ended March 31, 2024, a substantial decline from the previous year's net income of $48.7 million or $0.45 per share.
The company generated no revenue for the quarter, as opposed to $146.3 million reported in similar periods of last year.
There was a significant rise in the quarter's total operating expenses to $126.2 million, primarily due to increased development and compensation costs.
The company received a milestone payment of $50 million from Royalty Pharma post the completion of Phase 3 OCEAN Outcomes Trial enrollment of olpasiran by Amgen. They had earlier generated $450 million gross proceeds from an equity financing in January.
Business Progress:
Arrowhead expounds on their focus on the cardiometabolic space, with two late-stage drug candidates, plozasiran and zodasiran, backed by data from over 1,000 human subjects.
NDAs are planned to be filed nearly every year over the next five to six years to expand labels of plozasiran and zodasiran.
Anticipate launching two more drug candidates for obesity and metabolic disease this year while preparing for the commercial launch of plozasiran as an FCS treatment possibly in 2025.
The firm is currently expanding their medical affairs team and commercial infrastructure to support upcoming launches. They have multiple drug candidates in varied stages of clinical development targeting muscular diseases, complement diseases and pulmonary conditions.
Arrowhead expects to have 18 clinical programs by year-end, including two new clinical programs targeting obesity and metabolic disease. They also plan a 2024 Summer Series of R&D webinars to detail their work.
Completed the Phase 3 PALISADE study for plozasiran and initiated two Phase 3 SHASTA studies for the same in patients with severe hypertriglyceridemia. FDA feedback received for a Phase 3 program on atherosclerotic cardiovascular disease, awaiting approval.
Two new candidates ARO-DM1 and AROCFB have been initiated for clinical studies. Arrowhead plans to proceed to Phase 2 for the drug RAGE in patients with moderate-to-severe asthma, due to its safety and tolerability. They are hoping to start this Phase 2 trial in Q4.
Plozasiran had positive results in patients with high triglycerides, but further results are awaited, with high hopes for the outcome of a study on FCS. Future potential licensing or commercialization partnerships were mentioned, but no details provided.
The firm reports a safer and more tolerable 25 milligram dose with comparable efficacy to the 50 milligram dose, starting a Phase 1 2a trial last month for AROCFB.
Significant dosing advantage observed for AROC3, showing a knockdown of 88%, lasting three to four months post a single dose. The company plans to start the Summer Series meetings later this month.
More details: Arrowhead Pharmaceuticals IR
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