Eagle Pharmaceuticals Reports Fourth Quarter and Full Year 2020 Results and Provides Pipeline Review

Rhea-AI Summary

Eagle Pharmaceuticals (Nasdaq: EGRX) reported strong financial results for Q4 2020 and the full year, highlighting a 36% increase in adjusted non-GAAP earnings year-over-year. Q4 revenue reached $49.9 million, driven by product sales growth of Ryanodex and Belrapzo. The company received a complete response letter from the FDA regarding its ANDA for vasopressin, but plans to resubmit by mid-2021. Full-year revenue was $187.8 million, down from $195.9 million in 2019, with net income of $12.0 million. Eagle intends to launch Pemfexy in February 2022 and remains focused on growth opportunities.

Positive

• 36% year-over-year growth in adjusted non-GAAP earnings.
• Q4 revenue of $49.9 million, up from $48.3 million in Q4 2019.
• Successful product sales growth, including $10.2 million from Belrapzo.
• Plans to re-submit ANDA for vasopressin, with FDA prioritizing the application.

Negative

• Full-year revenue declined to $187.8 million from $195.9 million in 2019.
• Net income decreased from $14.3 million in 2019 to $12.0 million in 2020.
• Royalty revenue fell from $32.8 million in Q4 2019 to $27.0 million in Q4 2020.

Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) (“Eagle” or the “Company”) today announced financial results for the three and twelve months ended December 31, 2020, and reviewed key pipeline programs.

Business and Recent Highlights:

• Posted strong year-over-year adjusted non-GAAP earnings growth of 36%;
• Received a complete response letter (“CRL”) from U.S. Food and Drug Administration (“FDA”) for its Abbreviated New Drug Application (“ANDA”) for vasopressin. Eagle had a post-CRL meeting with FDA late last week and believes it has clear agreement on how to proceed. As previously disclosed, FDA restated that it has prioritized Eagle’s ANDA, and it is also flagged as a COVID priority. Eagle plans to re-submit its ANDA by mid-year. The 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 180 days of exclusivity.
• Added four experienced pharmaceutical industry executives to clinical, formulations and commercial leadership teams as follows: Judith (“Judi”) Ng-Cashin, M.D., is EVP and Chief Medical Officer; John Kimmet, is EVP, Oncology and Acute Care Marketing; Valentin R. Curt, M.D., is SVP, Clinical Drug Development; and Gaozhong Zhu, Ph.D., is SVP, Pharmaceutical Development, and
• Continued productive engagement with FDA for EA-114, the Company’s fulvestrant product candidate. The Company now has agreement for the clinical design and study endpoints, and following additional formulation work, intends to begin a clinical trial in patients.

Financial Highlights

Fourth Quarter 2020

• Total revenue for Q4 2020 was $49.9 million, compared to $48.3 million in Q4 2019, primarily reflecting increased product sales of Ryanodex and Belrapzo.
• Q4 2020 net income was $8.1 million, or $0.62 per basic and $0.60 per diluted share, compared to net income of $1.0 million, or $0.07 per basic and diluted share in Q4 2019.
• Q4 2020 adjusted non-GAAP net income was $12.8 million, or $0.98 per basic and $0.96 per diluted share, compared to adjusted non-GAAP net income of $6.7 million, or $0.49 per basic and $0.48 per diluted share, in Q4 2019.
• Cash and cash equivalents were $103.2 million, net accounts receivable was $51.1 million, and debt was $34 million as of December 31, 2020.

Full Year 2020

• Total revenue for the 12 months ended December 31, 2020 was $187.8 million, compared to $195.9 million in 2019. 2020 included a $5.0 million milestone from SymBio for regulatory approval of Treakisym ready-to-dilute (250 ml) liquid bendamustine formulation.
• 2020 net income was $12.0 million, or $0.89 per basic and $0.87 per diluted share, compared to net income of $14.3 million, or $1.04 per basic and $1.01 per diluted share in 2019.
• 2020 adjusted non-GAAP net income was $48.7 million, or $3.62 per basic and $3.54 per diluted share, compared to adjusted non-GAAP net income of $36.9 million, or $2.68 per basic and $2.61 per diluted share in 2019.
• From August 2016 through December 31, 2020, Eagle has repurchased $206.9 million of its common stock.

“2020 proved to be a strong earnings year for Eagle, with 36% year-over-year growth, despite the significant challenges brought about by the COVID-19 pandemic. Our balance sheet remains healthy and provides a solid basis to support our development programs and future growth prospects. Our key pipeline products – vasopressin, fulvestrant and Ryanodex for nerve agent exposure – represent significant opportunities, and we are pleased to have a path forward. We remain committed to completing the additional work to advance them through the regulatory process,” stated Scott Tarriff, Chief Executive Officer of Eagle Pharmaceuticals.

“Looking ahead, we have our exclusive Pemfexy launch in February 2022 and SymBio sales ramping in Japan. At the same time, we will continue pursuing both organic and inorganic opportunities that will deliver growth for many years to come,” concluded Tarriff.

Fourth Quarter 2020 Financial Results

Total revenue for the three months ended December 31, 2020 was $49.9 million, as compared to $48.3 million for the three months ended December 31, 2019.

Q4 2020 BELRAPZO product sales were $10.2 million, compared to $7.6 million in Q4 2019.

Q4 2020 RYANODEX product sales were $7.9 million, compared to $3.5 million in Q4 2019.

Royalty revenue was $27.0 million in the fourth quarter of 2020, compared to $32.8 million in the fourth quarter of 2019. BENDEKA royalties were $27.0 million in the fourth quarter of 2020, compared to $32.4 million in the fourth quarter of 2019. A summary of total revenue is outlined below:

	Three Months Ended December 31,
	2020

FAQ

What were Eagle Pharmaceuticals' financial results for Q4 2020?

Eagle Pharmaceuticals reported Q4 2020 revenue of $49.9 million, with a net income of $8.1 million.

What is the adjusted non-GAAP earnings growth for Eagle Pharmaceuticals?

Eagle Pharmaceuticals experienced a 36% year-over-year growth in adjusted non-GAAP earnings.

What challenges did Eagle Pharmaceuticals face regarding its FDA applications?

Eagle received a complete response letter from the FDA for its vasopressin ANDA but plans to re-submit by mid-2021.

How did Eagle Pharmaceuticals' full-year revenue compare to 2019?

Eagle's full-year revenue for 2020 was $187.8 million, down from $195.9 million in 2019.

When is the Pemfexy launch scheduled?

The exclusive Pemfexy launch is planned for February 2022.