3 TherapeuticsMD (TXMD) Investor Meeting Takeaways - Jefferies

Jefferies anlayst, Chris Howerton, hosted investor meetings with TherapeuticsMD (NYSE: TXMD) that provided visibility on 3 key topics.

Key takeaways:

1) '004 launch - mgmt believes features of convenience, efficacy & pot'l removal of black-box warnings will drive meaningful market share

2) ongoing pivotal '001 trial - mgmt sees trial as low risk due to known activity of E&P doses

3) compounding pharmacies - mgmt/ KOL believes it is easy to incentivize compounding pharmacies to distribute TXMD products and that this in turn will drive rapid market adoption of '001

Timing and strategy of '004 (vaginal estrogen [E], aka Vagicap) commercial launch. In 4Q15, TXMD reported positive, pivotal topline results for '004 and mgmt continues to expect to present a full dataset for this trial at the Endocrine society meeting (Apr 1-4 in Boston) and to submit the NDA for '004 in mid-16 (implied PDUFA/approval in mid-17).

Expectations for ongoing, pivotal ph 3 trial for '001 (oral estrogen and progesterone, or E+P). The ph 3 'Replenish' trial for '001 is completely enrolled (last patient in Oct-15), and mgmt expects to report topline results by YE16. In this trial, 4 doses are being evaluated: 1mg E + 100mg P, 0.5mg E + 100mg P, 0.5mg E + 50mg P & 0.25mg E + 50mg P. Mgmt believes that the overall clinical risk for this trial is relatively low due to the known efficacy activity of the 3 highest doses, and note that the lowest dose was included in the trial at the urging of the FDA to evaluate a likely ineffective dose.

Potential value of distribution through compounding pharmacies. The compounding KOL (David Miller, former CEO of IACP) highlighted the shrinking profit margins & cash flows for compounding pharmacies due to recent regulatory & 3rd-party payer actions. This dynamic has created a need for the industry to seek new products to distribute, such as '001. Mgmt/KOL believe incentivizing compounders to distribute TXMD's products will drive rapid & meaningful market share of '001 and perhaps '004 as well.

No change to Buy rating or $18 PT.

For an analyst ratings summary and ratings history on TherapeuticsMD click here. For more ratings news on TherapeuticsMD click here.

Shares of TherapeuticsMD closed at $6.80 yesterday.

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