TherapeuticsMD, Inc. (TXMD) experienced a decrease of 9.76% in aftermarket. However, the last trading session closed at $0.451 with a decline of 3.3%.
Revisions to Manufacturing Testing Limits for ANNOVERA – What’s up?
On 10th December 2021, TXMD announced that the FDA assessed that the sNDA previously filed by the Company would not be able to accept modifications to certain manufacturing testing limitations for ANNOVERA. Moreover, the FDA gave comments and requested further information in its comprehensive response letter, which might support the approval of changes to specific manufacturing testing limitations. Under the existing authorized standards, the Company will continue to produce and distribute ANNOVERA.
To account for typical commercial manufacturing variance, the sNDA recommended modest adjustments to the in vitro release testing standard for ANNOVERA. The proposed changes to the production testing limitations were filed by the Company in order to allow it to grow supply effectively and promptly in order to satisfy expected patient demand for ANNOVERA.
Now what?
Finally, the company will be able to manufacture and distribute ANNOVERA in accordance with the current standard, and it will engage with the FDA to resolve its concerns.
Third Quarter 2021 Results – How’s the quarter?
TXMD reported third-quarter 2021 results on 11th November 2021. The company stated the net product revenue of $11.8 million was up $5.4 million. Moreover, about 8,350 prescriptions for ANNOVERA were issued to patients and prescriptions grew by 62.7 percent. Not only this but ANNOVERA was prescribed by over 4,500 health care professionals (HCPs) in the third quarter, with roughly a third of them being first-time prescribers. Lastly, ANNOVERA has been prescribed by a total of 9,450 HCPs.
What’s Next?
TXMD has made major modifications to the company plan with the hopes of achieving EBITDA breakeven in the second half of 2022. In particular, the company has established a cost-cutting strategy and a more focused focus on healthcare professionals. Moreover, the consistent progress made during the third quarter, particularly the high year-over-year rise in ANNOVERA prescriptions, demonstrates that these changes are already generating benefits.
Leadership Changes by TXMD – Latest Updates
TXMD announced on 11th November 2021 that Hugh O’Dowd has been appointed as the company’s Chief Executive Officer and a member of the board of directors. Hugh is a seasoned leader with a proven track record of success, and he has already made significant contributions to the organization in just a few months. The company has a lot of confidence in its ability to take TXMD to the next stage of development.
