Eagle Pharmaceuticals Reports First Quarter 2021 Results

Rhea-AI Summary

Eagle Pharmaceuticals announced its Q1 2021 financial results, reporting total revenues of $41.2 million, down from $46.0 million in Q1 2020, attributed to decreased sales of RYANODEX and lower royalties from BENDEKA. The net loss narrowed to $0.4 million, compared to $2.9 million a year prior. Significant business highlights include FDA study completion for vasopressin, TREAKISYM approval in Japan, and active discussions for new in-licensing opportunities. Eagle anticipates $20-$25 million from TREAKISYM in 2022.

Positive

• Anticipation of 180-day exclusivity for vasopressin post-CRL response.
• TREAKISYM approval in Japan broadens market opportunities significantly.
• Expected revenue of $20-$25 million in 2022 from TREAKISYM formulations.
• Appointment of Dr. Luciana Borio to the Board strengthens governance.
• Active pursuit of in-licensing and acquisition candidates to enhance portfolio.

Negative

• Total revenue decreased by 10.4% compared to Q1 2020.
• Adjusted non-GAAP net income dropped by 72.6% year-over-year.
• RYANODEX sales fell 40.4% from Q1 2020.
• Royalty revenue decreased by 15.0% compared to the previous year.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three months ended March 31, 2021.

Business and Recent Highlights:

• Completed the last study required by FDA for the Company’s vasopressin product and expect to have the results shortly. Eagle plans to respond to the CRL issued for its first-to-file Abbreviated New Drug Applicable (“ANDA”) for vasopressin in full by mid-year. The Company’s patent trial against Endo Par Innovation Company, LLC was postponed and is now scheduled to begin on July 7, 2021. The Company believes it will have first-to-file 180 day exclusivity for vasopressin;
• Approval of TREAKISYM (bendamustine) RTD formulation, in combination with rituximab for treatment of relapsed or refractory diffuse large B-cell lymphoma (“r/r DLBCL”) received from the Pharmaceuticals and Medical Devices Agency (“PMDA”) in Japan. This represents a meaningful extension of Eagle’s bendamustine franchise and is expected to significantly increase the market opportunity;
• Filing of TREAKISYM RI (50ml) liquid formulation with the PMDA in Japan. Eagle expects approximately $20-$25 million from combined royalty and milestone revenue in 2022 for TREAKISYM (bendamustine) RTD and RI formulations;
• Appointed former FDA Official and Public Health Expert Dr. Luciana Borio to its Board of Directors; and
• In active discussions for several promising in-licensing and acquisition candidates that the Company believes will strengthen its portfolio and pipeline going forward.

Financial Highlights

First Quarter 2021

Total revenue for Q1 2021 was $41.2 million, compared to $46.0 million in Q1 2020, primarily reflecting decreased product sales of RYANODEX^® and royalty revenue of BENDEKA^®.

• Q1 2021 net loss was $0.4 million, or $0.03 per basic and diluted share, compared to net loss of $2.9 million, or $0.21 per basic and diluted share in Q1 2020.
• Q1 2021 adjusted non-GAAP net income was $3.2 million, or $0.24 per basic and diluted share, compared to adjusted non-GAAP net income of $11.7 million, or $0.86 per basic and $0.84 per diluted share, in Q1 2020.
• Cash and cash equivalents were $105.2 million, net accounts receivable was $44.9 million, and debt was $32.0 million as of March 31, 2021.

“Vasopressin is tracking as expected. The trial is now less than two months away and we have now completed the last study required to submit our response to the CRL to the FDA. Our expectation remains that we will receive final approval in time to bring the product to market this year. We believe we also have an outstanding and large opportunity with TREAKISYM in Japan representing another extension of our bendamustine franchise. Equally important and exciting is the PEMFEXY^™ launch early next year, which gives us four months of initial exclusivity,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“We are now in late-stage diligence for several in-licensing opportunities that would leverage our capabilities, meet our criteria and broaden our portfolio and pipeline. We will aim to finalize a few such transactions that have the potential to bolster our earnings both in the short and longer term,” concluded Tarriff.

First Quarter 2021 Financial Results

Total revenue for the three months ended March 31, 2021 was $41.2 million, as compared to $46.0 million for the three months ended March 31, 2020.

Q1 2021 BELRAPZO^® product sales were $5.7 million, compared to $4.6 million in Q1 2020.

Q1 2021 RYANODEX product sales were $6.8 million, compared to $11.4 million in Q1 2020.

Royalty revenue was $24.1 million in the first quarter of 2021, compared to $28.3 million in the first quarter of 2020. BENDEKA royalties were $23.8 million in the first quarter of 2021, compared to $28.0 million in the first quarter of 2020. A summary of total revenue is outlined below:

	Three Months Ended March 31,
	2021		2020
	(unaudited)		(unaudited)
Revenue (in thousands):

FAQ

What were Eagle Pharmaceuticals' total revenues for Q1 2021?

Eagle Pharmaceuticals reported total revenues of $41.2 million for Q1 2021.

How did net loss change for Eagle Pharmaceuticals in Q1 2021?

The net loss for Q1 2021 was $0.4 million, an improvement from a net loss of $2.9 million in Q1 2020.

What is the significance of TREAKISYM's approval in Japan for EGRX?

The approval of TREAKISYM in Japan significantly extends Eagle's product line and market opportunities.

What is Eagle Pharmaceuticals' projection for TREAKISYM revenue in 2022?

Eagle Pharmaceuticals expects approximately $20-$25 million from combined royalties and milestones for TREAKISYM in 2022.

When is the patent trial against Endo Par scheduled?

The patent trial against Endo Par is scheduled to begin on July 7, 2021.