In a statement Tuesday, CEO Al Altomari called the quarter that ended March 31 “transformational” for the company.
In February Agile achieved a major milestone -- it won US Food and Drug Administration approval of Twirla, a low-dose prescription contraceptive delivered through the skin via the company’s proprietary patch technology.
Altomari said New Jersey-based Agile is moving forward -- despite the coronavirus (COVID19) shutdown and health crisis -- with its precommercial activities to bring Twirla to market in the fourth quarter of 2020.
“With respect to our manufacturing process, we have completed production of the pre-validation batch and subject to final quality control testing that we expect to be completed soon, we will transition into the final validation phase,” Altomari said. “We plan to initiate the manufacture of our validation batches at the same time that we expect to build our sales force and commercial infrastructure to facilitate the product launch.”
Altomari added: “By raising more than $68 million in debt and equity financing in recent months, we expect to have the financial runway needed to achieve our next milestone, which is the initial shipment of Twirla, so that we can begin taking a share of the $4.1 billion estimated potential addressable market. It was a transformational quarter for Agile with FDA approval of Twirla, a truly game-changing moment that now enables us to focus on commercialization.”
In the second quarter of 2020, the company said it plans to begin hiring and training an initial sales team, which it estimates to be in the range of 70 to 100 people. It intends to begin to ship product to wholesalers in the fourth quarter of 2020.
Outlook for 2020
Moving forward, the company said it plans to monitor spending closely and expects operating expenses for the full year 2020 to be in the range of $52 million to $56 million, with general and administrative expenses accounting for about 70% of the spending as it builds out its commercial infrastructure.
Net revenue in the fourth quarter of 2020, reflecting the initial launch of Twirla, is expected to be in the range of $4 million to $6 million, Agile said.
Based on the company’s current business plan and ability to get Twirla launched, Agile said it believes that its cash and cash equivalents as of March 31 will be sufficient to meet its projected operating requirements through the end of 2021.
If the COVID-19 outbreak or other factors impact the company’s business plan or its ability to generate revenue from the launch of Twirla, Agile said it believes it has the ability to revise its commercial plans, including curtailing sales and marketing spending, to allow it to continue to fund its operations.
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