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Endo (ENDP) Inks Deal for Osteoarthritis Knee Pain Drug
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Endo International plc recently announced that its subsidiary Endo Ventures Limited has entered into an agreement with clinical-stage specialty pharmaceutical company Taiwan Liposome Company, Ltd. ("TLC").
Both the companies will commercialize TLC599. The candidate is an extended and controlled release liposomal formulated dexamethasone for chronic knee osteoarthritis (OA) pain. It is currently in phase III development for the treatment of osteoarthritis knee pain.
Per the terms of the agreement, TLC will primarily be responsible for the development of the product. On the other hand, Endo will primarily be responsible for obtaining regulatory approval and commercializing the product in the United States.
Endo will have exclusive rights to manufacture, market, sell and distribute the product in the United States upon receipt of regulatory approval.
In exchange, TLC will receive an upfront payment of $30 million. It is also eligible to receive up to an additional $110 million based on the achievement of certain development, regulatory, and manufacturing milestones related to the initial indication for the treatment of OA knee pain.
Additionally, TLC will be eligible to receive payments based on the achievement of certain commercial milestones and royalties based on the product's net sales in the United States.
Endo will account for the upfront payment of $30 million in the second quarter as acquired in-process research and development. Endo had not taken this into account when it provided guidance for the second quarter on May 5, 2022, as the transaction was signed after the date of the second-quarter earnings release.
Revenues for the second quarter are projected to be $500-$525 million. Adjusted loss per share is estimated at 17 cents to 15 cents.
The guidance for the second quarter was disappointing due to challenging market dynamics for Vasostrict, which faces generic completion.
Endo has lost 91.9% in the year so far compared with the industry's 28.7% decline.
Image Source: Zacks Investment Research
Last month, shares tanked significantly after a Wall Street report stated that the company has started negotiations with its lenders and senior bondholders about a possible restructuring of more than $8 billion of debt.
Please note that Endo is already in deep trouble with several litigation suits over opioid sales, which has been an overhang on its shares for quite some time now.
Endo reported first-quarter earnings of 66 cents per share, beating the Zacks Consensus Estimate of 44 cents but declining from 73 cents in the year-ago quarter. A significant increase in litigation expenses and selling, general and administrative expenses hurt the bottom line.
As of Mar 2022, the company had $1.4 billion of cash and equivalents and long-term debt of $8.0 billion.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
Loss estimates for Bolt for 2022 have narrowed to $2.87 from $2.99 in the past 60 days. Bolt surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average surprise being a negative 17.29%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.
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Endo (ENDP) Inks Deal for Osteoarthritis Knee Pain Drug
Endo International plc recently announced that its subsidiary Endo Ventures Limited has entered into an agreement with clinical-stage specialty pharmaceutical company Taiwan Liposome Company, Ltd. ("TLC").
Both the companies will commercialize TLC599. The candidate is an extended and controlled release liposomal formulated dexamethasone for chronic knee osteoarthritis (OA) pain. It is currently in phase III development for the treatment of osteoarthritis knee pain.
Per the terms of the agreement, TLC will primarily be responsible for the development of the product. On the other hand, Endo will primarily be responsible for obtaining regulatory approval and commercializing the product in the United States.
Endo will have exclusive rights to manufacture, market, sell and distribute the product in the United States upon receipt of regulatory approval.
In exchange, TLC will receive an upfront payment of $30 million. It is also eligible to receive up to an additional $110 million based on the achievement of certain development, regulatory, and manufacturing milestones related to the initial indication for the treatment of OA knee pain.
Additionally, TLC will be eligible to receive payments based on the achievement of certain commercial milestones and royalties based on the product's net sales in the United States.
Endo will account for the upfront payment of $30 million in the second quarter as acquired in-process research and development. Endo had not taken this into account when it provided guidance for the second quarter on May 5, 2022, as the transaction was signed after the date of the second-quarter earnings release.
Revenues for the second quarter are projected to be $500-$525 million. Adjusted loss per share is estimated at 17 cents to 15 cents.
The guidance for the second quarter was disappointing due to challenging market dynamics for Vasostrict, which faces generic completion.
Endo has lost 91.9% in the year so far compared with the industry's 28.7% decline.
Image Source: Zacks Investment Research
Last month, shares tanked significantly after a Wall Street report stated that the company has started negotiations with its lenders and senior bondholders about a possible restructuring of more than $8 billion of debt.
Please note that Endo is already in deep trouble with several litigation suits over opioid sales, which has been an overhang on its shares for quite some time now.
Endo reported first-quarter earnings of 66 cents per share, beating the Zacks Consensus Estimate of 44 cents but declining from 73 cents in the year-ago quarter. A significant increase in litigation expenses and selling, general and administrative expenses hurt the bottom line.
As of Mar 2022, the company had $1.4 billion of cash and equivalents and long-term debt of $8.0 billion.
Zacks Rank & Stocks to Consider
Endo currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks are Alkermes (ALKS - Free Report) , Bolt Therapeutics (BOLT - Free Report) and Geron Corporation (GERN - Free Report) . While Alkermes sports a Zacks Rank #1 (Strong Buy), Geron and Bolt have a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Loss estimates for ALKS for 2022 have narrowed to 3 cents from a loss of 14 cents in the past 60 days. Alkermes surpassed estimates in all of the trailing four quarters, the average surprise being 350.48%.
Loss estimates for Bolt for 2022 have narrowed to $2.87 from $2.99 in the past 60 days. Bolt surpassed estimates in two of the trailing four quarters and missed the mark in the remaining two, the average surprise being a negative 17.29%.
Loss estimates for GERN for 2022 have narrowed by 6 cents in the past 60 days. Geron surpassed estimates in three of the trailing four quarters and missed the mark in the remaining one, the average surprise being 1.07%.