Valeritas Holdings, Inc. (NASDAQ: VLRX) is a commercial-stage medical technology company, focuses on the development and commercialization of technologies to treat patients with Type 2 diabetes in the United States and China. It offers V-Go, a wearable insulin delivery device for basal-bolus therapy.
The company shares jumped this week after the company touted positive results from its Enable study, showing that patients who switched from insulin pens and syringes to the company’s wearable V-Go insulin delivery device experienced improved blood glucose levels and lowered their daily insulin dose.
In Monday’s session VLRX shares, in intra-day trading, moved from $1.63/share to $2.08 per share on unusually high trading volume of 26 million shares.
June 25, 2018. Valeritas announced positive results from the EffectiveNess of V-Go WeArable Insulin Delivery for Basal-BoLus ThErapy (ENABLE) Study. Three poster presentations at the American Diabetes Association Meeting in Orlando, Florida, reported that patients who switched from insulin pens and syringes to V-Go significantly improved blood glucose while lowering insulin dose. https://finance.yahoo.com/news/valeritas-enable-study-demonstrates-significant-110000422.html
The VLRX primary target market consists of the approximately 5.6 million patients with type 2 diabetes who currently take injectable insulin, of which up to 4.5 million may not be achieving their target blood glucose goal. This patient population represents a $16.5 billion annual U.S. market when applying the annual wholesale acquisition cost, or WAC, of V-Go to the 4.5 million patients not achieving glycemic control. WAC is the gross price paid by wholesalers and does not take into account fees, discounts, and rebates from us. If the Company were able to capture even 15% of this 4.5 million patient population, that would represent $1.6 billion in annual revenue.
Products
V-Go Insulin Delivery
Users fill V-Go with their prescribed insulin using an included disposable filling accessory called the EZ Fill. V-Go is then applied like a patch to the skin in a discreet location like the abdomen or back of the arm. With the push of a button, patient can then start the flow of insulin (preset basal rate of insulin) and self-administer their bolus doses at mealtimes.
V-Go is a simple, fully disposable device for the delivery of basal-bolus insulin therapy in adults with Type 2 diabetes. V-Go provides a continuous preset basal rate of insulin and allows for on-demand bolus dosing around mealtimes, thereby providing an alternative to taking multiple daily insulin injections.
V-Go is small, lightweight and worn under the patients clothing. It measures just 2.4 x 1.3 x 0.5 inches and weighs approximately 1 ounce when filled with insulin. Patients apply a new V-Go to the skin daily for one 24-hour period. V-Go is not electronic, making it easy to operate and use.
Short video on the V-Go device.
https://www.valeritas.com/v-go/insulin-delivery-with-v-go/default.aspx
The h-Patch technology that VLRX has developed for insulin delivery could also be used for the delivery of other medications.
About
Valeritas Holdings, Inc., a commercial-stage medical technology company, focuses on the development and commercialization of technologies to treat patients with Type 2 diabetes in the United States and China. It offers V-Go, a wearable insulin delivery device for basal-bolus therapy. The company also develops h-Patch, a controlled delivery technology platform; Mini-Ject technology for needle-free injection systems; and Micro-Trans technology for microneedle design, fabrication, and drug delivery. In addition, its products include V-Go Prefill, which is in the design-development stage for eliminating the device-filling process and the need for EZ fill refrigeration for patients with Type 2 diabetes; and V-Go Link that is in the early stages of development for real-time tracking information of basal and bolus dosing utilization. The company sells V-Go to third-party wholesalers and medical supply distributors in the United States. Valeritas Holdings, Inc. was founded in 2006 and is headquartered in Bridgewater, New Jersey.
Financial review Q1 2018
Revenue was $6.1 million for the three months ended March 31, 2018, compared to $4.6 million for the three months ended March 31, 2017, an increase of 31.9%.
Cost of goods sold was $3.2 million for the three months ended March 31, 2018, compared to $2.9 million for the three months ended March 31, 2017, an increase of $0.3 million.
Gross profit as a percentage of revenues, or gross margin, for the three months ended March 31, 2018 was 47.6%, compared to 37.6% for the three months ended March 31, 2017.
Total research and development expense was $2.1 million for the three months ended March 31, 2018, compared to $1.6 million for the three months ended March 31, 2017, an increase of $0.5 million.
Selling, general and administrative expenses were $11.5 million for the three months ended March 31, 2018, compared to $10.4 million for the three months ended March 31, 2017, an increase of $1.0 million.
Interest expense was $0.9 million for the three months ended March 31, 2018, compared to $1.6 million for the three months ended March 31, 2017, a decrease of $0.6 million.
Net loss for the quarter was $11.5 million.
Stock influences and risk factors
The successful future of V-Go could act as a catalyst for the company shares:
They have incurred significant operating losses since inception and anticipate continued losses for the foreseeable future;
Competitive products or other technological breakthroughs for the treatment or prevention of diabetes may render their products obsolete or less desirable;
Manufacturing risks, including risks related to manufacturing in China, may adversely affect the ability to manufacture their products.
Stock chart
On Monday, June 25, 2018, in intra-day trading, VLRX was at $1.70 on traded volume of 25.8 million shares. The current RSI (14) is 54.55
At $1.70, VLRX Shares are trading above their 50 DMA of $1.65 and below their 200 DMA of $2.75
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