Valeritas Holdings, Inc. (NASDAQ:VLRX), a medical technology company and maker of the V-Go® Wearable Insulin Delivery device, which uses its proprietary h-Patch™ technology, today announced revised revenue guidance and preliminary financial results for the fourth quarter and year ended December 31, 2019 as a result of a manufacturing yield issue that has caused a temporary disruption in supply.
The issue has caused a delay in available product and the Company will be unable to ship product until the issue is resolved and the supply chain is replenished. The Company is working toward resuming shipment as soon as possible and will provide additional information as it becomes available. Patients or prescribers who have any questions should contact the Company’s customer service line at 1-866-881-1209.
Due to this situation, the Company has updated its revenue guidance for the fourth quarter of 2019 to be $8.0 to $8.2 million and full year 2019 revenue to be $30.2 to $30.4 million. The Company also expects to incur a temporary reduction in yields and an incremental one-time write-off of inventory of up to $8 million, which would result in a revised negative gross margin expectation for the fourth quarter of 2019. Aside from the one-time inventory write-off expense and increased cost of goods sold due to the lower manufacturing yields, the Company does not expect any other material changes in recurring operating expenses from the third quarter of 2019. The Company expects to end the year with approximately $11 million in cash and cash equivalents on hand at December 31, 2019, which it believes would fund operations into February 2020, excluding any additional expenses incurred related to lower yields in January and in pursuing strategic alternatives, as described below.