Valeritas Holdings Inc (NASDAQ: VLRX) saw tremendous gains on Monday, June 25th, closing the day up 13.38% and enjoying intra-day highs of more than 30%. The gains proved to be the result of data released by the company at the American Diabetes Association Meeting in Orlando, Florida. The data, provided by way of 3 poster presentations, suggest that V-Go may be more effective than traditional insulin delivery options.
What Is V-Go?
V-Go is a wearable insulin delivery system that is designed to change the way we treat diabetes. Traditional insulin delivery systems like syringes and insulin pens are an option for treating Type 2 diabetes by providing pre-measured doses of insulin to the body at various times throughout the day. However, the body’s natural release of insulin works very differently, creating some challenges in the treatment of this condition.
Valeritas Holdings is working to change that with V-Go. The device is a wearable basal-bolus insulin delivery system that helps to control blood glucose levels in adults with Type 2 diabetes. However, instead of using the dosing model traditionally used, V-Go is designed to mimic the physiologic pattern of insulin release by the body. As a result, V-Go provides patients with a continuous preset basal rate of insulin, also providing patients with on-demand bolus dosing at meal times.
The Data Is Hard To Argue
The data offered in the poster presentations at the American Diabetes Association Meeting proved to be overwhelmingly positive. Here’s a brief overview of the data that was provided in each of the 3 poster presentations:
Poster 988 – EffectiveNess of V-Go WeArable Insulin Delivery for Basal-BoLus ThErapy (ENABLE) Study: A Multicenter Retrospective Real World Evaluation in Type 2 Diabetes.
In the first poster presentation provided, the company evaluated the clinical benefits of switching to V-Go from traditional insulin delivery options for type 2 diabetes patients. Here are the key points from the poster:
- 283 patients were enrolled in the ENABLE study.
- The study demonstrated both clinically and statistically significant reductions in A1C by more than 1%. A1C is a key measure of blood glucose control.
- The study also demonstrated clinically and statistically significant reductions in total daily dose (TDD).
- Results were assessed at three and seven months.
- The percentage of high-risk patients, meaning patients with an A1C level of more than 9%, reduced by nearly 50% after switching from traditional insulin delivery to V-Go.
- More than 50% of patients included in the study achieved A1C levels of less than 8%.
- After three months of V-Go use, A1C levels fell by -1.01 with a P value of less than 0.0001.
- After seven months of V-Go use, A1C was reduced by -1.04 on average with a P value of less than 0.0001.
- After 3 months of V-Go Use, TDD reduced by -17 U/day with a P value of less than 0.0001.
- After 7 months of V-Go use, TDD reduced by -14 with a P value of less than 0.0001.
Poster 989 – Achievement of Glycemic Targets when Switching from Basal-Bolus Therapy to V-Go for Insulin Delivery in Type 2 Diabetes.
In the second poster presentation, Valeritas provided an analysis from the ENABLE study, confirming that V-Go provided clinical benefit in a patient population that proved to be poorly controlled through traditional insulin delivery. Here are the key points from this poster:
- Data from 186 patients with type 2 diabetes was analyzed for this poster presentation.
- The analysis demonstrated a reduction of A1C by -1.0 at three months. This reduction was sustained at seven months and was statistically significant with a P value of less than 0.0001.
- Also, insulin TDD was reduced by 30%, representing a reduction of 84 U/day after three months and 59 U/day after seven months.
- In order to determine if TDD was a factor in the change seen in A1C, VLRX divided patients into three approximately equal groups based on baseline TDD. These groups consisted of:
- < 60 U/day with a mean of 46 U/day;
- 60 to 90 U/day with a mean of 72 U/day; and
- >90 U/day with a mean of 134 U/day.
- The results provided in the poster showed that all TDD groups saw statistically significant reductions in A1C with results of -1.0, -0.8, and -1.2 respectively. Also, the results showed a P value of less than 0.0001 in all three subgroups.
Poster 990 – Clinical Outcomes with V-Go in Type 2 Diabetes based on Duration of Diabetes
Finally, the third poster presentation from the ENABLE study evaluated the impact of duration of diabetes on the change in A1C and insulin TDD when switching to V-Go from traditional insulin delivery. Here are the key points from this poster:
- Patients that had a known duration of diabetes (time in years with the condition) were broken up into five groups based on the number of years they have had diabetes.
- In all five subgroups, patients saw a clinically and statistically significant reduction in A1C after three and seven months.
- Four of the five subgroups also benefited from reductions in TDD. The subgroup with the lowest baseline TDD (15 to 20 years) maintained similar dosing to baseline when switching to V-Go.
The Opportunity May Be A Massive One
As investors, we want to know that there is a market for the product or products that we invest in. That’s definitely the case when it comes to V-Go. In fact, diabetes is one of the most devastating and widespread conditions in the United States, having an effect on approximately 9.4% of the American population according to the United States Center for Disease Control.
While traditional insulin delivery options have their benefits, there are also some major downsides. With the data showing that after switching from traditional delivery methods to V-Go, patients experience both reductions in A1C and reductions in total daily doses of insulin, V-Go could become a cornerstone in this massive market.
Consider The Risks
While the market for V-Go is a massive one, there are some risks to consider when thinking about getting involved in Valeritas. Here are the risks that come to mind:
- Competition – V-Go has been approved for some time now. However, sales have not been great, largely due to overwhelming competition. In fact, blockbuster treatments like Lantus® and Levemir® take the lion’s share of the market and benefit from having more than 1,000 sales representatives. In order for V-Go to compete in this market, it will need to greatly grow its sales force.
- Consistent Losses – Unfortunately VLRX has a history of consistent losses with no sign of profit coming any time soon.
There is no doubt that Valeritas has a product that could prove to be massively profitable in the V-Go asset. However, the company is going to have to overcome hurdles to reach this point. In particular, Valeritas will need to find a way to ramp up its sales efforts. This could include entering into a partnership with a larger company that has better sales resources or improving their sales force internally. Nonetheless, in order for the company to reach its full potential, it will need to improve sales. However, if this happens, this could prove to be a big win for investors who get in early on.
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