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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA
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<blockquote data-quote="madman" data-source="post: 202547" data-attributes="member: 13851"><div style="text-align: justify; max-width: %s">[URL unfurl="true"]https://www.globenewswire.com/news-release/2021/05/13/2229014/0/en/Acerus-Reports-First-Quarter-2021-Financial-Results.html[/URL]</div> </p><div style="text-align: justify; max-width: %s"><strong>COMPANY UPDATE AND OUTLOOK</strong></div> </p><div style="text-align: justify; max-width: %s"><strong>NATESTO</strong>®</div> </p><div style="text-align: justify; max-width: %s"><em>The Company continues to execute its strategy of focusing on the U.S. market for NATESTO®. During the quarter, the Company signed an agreement with Aytu BioPharma (f/k/a Aytu BioScience) (“Aytu”), whereby Acerus acquired all remaining rights to NATESTO® in the U.S. that were not already returned as part of the Company’s 2019 Amended and Restated Agreement with Aytu. By assuming full ownership of NATESTO and its U.S. distribution, the Company can leverage its commercial business unit to accelerate growth. In addition to Acerus selling to its existing specialty healthcare professionals, the Company gains full distribution rights and reporting of sales for any transaction in the U.S. market. Aytu has agreed to assist Acerus throughout a 120-day transition period from the effective date (March 31, 2021) and, during this period, will continue to provide distribution of NATESTO® under the terms of the existing License and Supply Agreement. NATESTO® sales will be recognized at the distributor level, which allows for better alignment of revenue to underlying prescription trends.</em></div> </p><div style="text-align: justify; max-width: %s"><em>After the end of the quarter, in May 2021, Acerus announced a NATESTO® co-promotion agreement with Amneal Pharmaceuticals that leverage that company’s extensive relationships with Endocrinology healthcare providers in the U.S. market. Under the terms of the agreement, Amneal will sell NATESTO® to its existing Endocrinology targets through June 30, 2024. In compensation for such marketing efforts, Amneal will receive a commission for most of the net profits attributed to Endocrinology targets in the three active promotional years, with Acerus retaining a low double-digit percentage of such net profits during the active promotion period. Amneal will also receive a three-year trailing royalty following the active promotion period, with compensation to Amneal decreasing from a majority of the net profits to a minority of the net profits.</em></div> </p><div style="text-align: justify; max-width: %s"><em><strong>Also subsequent to the end of the quarter, the Company received a Notice of Allowance for a <u>U.S. patent covering NATESTO®</u>. <u>When granted, Acerus expects this patent to be listed in the Orange Book, which will extend patent coverage through 2034</u>.</strong></em></div> </p><div style="text-align: justify; max-width: %s"><em><strong>Outside of the United States, the Maylen Farma agreement announced in the quarter expands the reach of NATESTO® to 20 countries across Europe, Central Asia, and the Middle East. Nations covered by the agreement include Belarus, Georgia, and Ukraine; Azerbaijan, Uzbekistan, Tajikistan, Kazakhstan, and Kyrgyzstan; Albania, Kosovo, North Macedonia, Serbia, and Bosnia and Herzegovina; the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Jordan, and Lebanon. The Company currently expects first orders under his agreement in the second quarter, with deliveries in the fourth quarter of 2021 and early 2022.</strong></em></div> </p><div style="text-align: justify; max-width: %s"><strong><em>The Company also remains optimistic about a return of NATESTO® to Canada during 2021. <u>The first batch of NATESTO® for this market has already been manufactured and is undergoing stability studies</u>. <u>At the same time, Acerus has begun the regulatory work and commercial preparations required to support the reintroduction of NATESTO® in Canada</u>.</em></strong></div></blockquote><p></p>
[QUOTE="madman, post: 202547, member: 13851"] [JUSTIFY='%s'][URL unfurl="true"]https://www.globenewswire.com/news-release/2021/05/13/2229014/0/en/Acerus-Reports-First-Quarter-2021-Financial-Results.html[/URL][/JUSTIFY] [JUSTIFY='%s'][/JUSTIFY] [JUSTIFY='%s'][B]COMPANY UPDATE AND OUTLOOK[/B][/JUSTIFY] [JUSTIFY='%s'][/JUSTIFY] [JUSTIFY='%s'][B]NATESTO[/B]®[/JUSTIFY] [JUSTIFY='%s'][I]The Company continues to execute its strategy of focusing on the U.S. market for NATESTO®. During the quarter, the Company signed an agreement with Aytu BioPharma (f/k/a Aytu BioScience) (“Aytu”), whereby Acerus acquired all remaining rights to NATESTO® in the U.S. that were not already returned as part of the Company’s 2019 Amended and Restated Agreement with Aytu. By assuming full ownership of NATESTO and its U.S. distribution, the Company can leverage its commercial business unit to accelerate growth. In addition to Acerus selling to its existing specialty healthcare professionals, the Company gains full distribution rights and reporting of sales for any transaction in the U.S. market. Aytu has agreed to assist Acerus throughout a 120-day transition period from the effective date (March 31, 2021) and, during this period, will continue to provide distribution of NATESTO® under the terms of the existing License and Supply Agreement. NATESTO® sales will be recognized at the distributor level, which allows for better alignment of revenue to underlying prescription trends.[/I][/JUSTIFY] [JUSTIFY='%s'][I][/I][/JUSTIFY] [JUSTIFY='%s'][I]After the end of the quarter, in May 2021, Acerus announced a NATESTO® co-promotion agreement with Amneal Pharmaceuticals that leverage that company’s extensive relationships with Endocrinology healthcare providers in the U.S. market. Under the terms of the agreement, Amneal will sell NATESTO® to its existing Endocrinology targets through June 30, 2024. In compensation for such marketing efforts, Amneal will receive a commission for most of the net profits attributed to Endocrinology targets in the three active promotional years, with Acerus retaining a low double-digit percentage of such net profits during the active promotion period. Amneal will also receive a three-year trailing royalty following the active promotion period, with compensation to Amneal decreasing from a majority of the net profits to a minority of the net profits.[/I][/JUSTIFY] [JUSTIFY='%s'][I][/I][/JUSTIFY] [JUSTIFY='%s'][I][B]Also subsequent to the end of the quarter, the Company received a Notice of Allowance for a [U]U.S. patent covering NATESTO®[/U]. [U]When granted, Acerus expects this patent to be listed in the Orange Book, which will extend patent coverage through 2034[/U].[/B][/I][/JUSTIFY] [JUSTIFY='%s'][I][/I][/JUSTIFY] [JUSTIFY='%s'][I][B]Outside of the United States, the Maylen Farma agreement announced in the quarter expands the reach of NATESTO® to 20 countries across Europe, Central Asia, and the Middle East. Nations covered by the agreement include Belarus, Georgia, and Ukraine; Azerbaijan, Uzbekistan, Tajikistan, Kazakhstan, and Kyrgyzstan; Albania, Kosovo, North Macedonia, Serbia, and Bosnia and Herzegovina; the United Arab Emirates, Kingdom of Saudi Arabia, Kuwait, Qatar, Bahrain, Jordan, and Lebanon. The Company currently expects first orders under his agreement in the second quarter, with deliveries in the fourth quarter of 2021 and early 2022.[/B][/I][/JUSTIFY] [JUSTIFY='%s'][I][/I][/JUSTIFY] [JUSTIFY='%s'][B][I]The Company also remains optimistic about a return of NATESTO® to Canada during 2021. [U]The first batch of NATESTO® for this market has already been manufactured and is undergoing stability studies[/U]. [U]At the same time, Acerus has begun the regulatory work and commercial preparations required to support the reintroduction of NATESTO® in Canada[/U].[/I][/B][/JUSTIFY] [/QUOTE]
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Testosterone Replacement, Low T, HCG, & Beyond
Testosterone and Men's Health Articles
TEMPORARY UNAVAILABILITY OF NATESTO® IN CANADA AND SOUTH KOREA
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