Summit Therapeutics PLC (SMMT) Earnings & Analysis

Latest quarter

Summit reported an adjusted loss per share of −$0.28 for the latest quarter, compared with the consensus estimate of −$0.26. Its diluted loss per share was −$0.28, compared with −$0.76 a year earlier.

The company recorded free cash flow of −$142.0 million, compared with −$66.7 million in the year-ago quarter. On the call, Chief Financial Officer Manmeet Soni said cash raised through Summit’s at-the-market equity facility offset cash used in operations during the quarter. He also said Summit had filed for a new facility to provide financing flexibility.

Compared with the preceding quarter, Soni said operating expenses increased primarily because of research and development spending on the Harmony GI III, Harmony III and Harmony VII clinical trials. He said the increase in non-GAAP operating expenses was also primarily related to research and development.

Adjusted EPS is the figure the consensus estimates, not the GAAP EPS above.

What management said on the call

President and Co-CEO Maki Zanganeh focused on updated survival data from the global Harmony study of ivonescimab with chemotherapy in a lung cancer setting. She said the overall and Western patient populations showed the same survival hazard ratio as Western patients spent more time in the study. Zanganeh added that no additional safety signals were observed in the latest data cut.

Zanganeh said the study’s primary overall survival analysis did not reach statistical significance. She also said the FDA had indicated that a statistically significant overall survival benefit was necessary to support authorization in that setting. Summit had made the updated results available to the agency, she said.

In response to questions about the regional data, Chief Business and Strategy Officer Dave Gancarz said “maturity in follow-up time is critical.” He said the later analysis showed a similar magnitude of benefit in Asian and Western patients when both had more follow-up time. Asked about the FDA review timetable, Gancarz said Summit did not expect the target date to move, although the decision belonged to the agency.

Zanganeh said enrollment was complete in both cohorts of Harmony III, which tests ivonescimab with chemotherapy as an initial lung cancer treatment. Gancarz told analysts that event rates had slowed and that the progression-free survival analysis was likely toward the middle or back end of the year. He expected a supporting interim survival analysis alongside it and another interim survival analysis independent of progression-free survival next year.

Zanganeh also discussed collaborations testing ivonescimab in combinations across cancer types. She said the Revolution Medicine collaboration had begun enrolling and that Summit expected initial data from its Arcus collaboration the following year.

Guidance

Dave Gancarz said Summit still expected Harmony III to reach the events needed for its progression-free survival analysis in the second half of the year. After event rates slowed, he said the timing was likely toward the middle or back end of the year.