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.
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.
The h-Patch technology that VLRX has developed for insulin delivery could also be used for the delivery of other medications.
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.
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
Traders News Source is a wholly owned subsidiary of Traders News Source LLC, herein referred to as TNS LLC.
Traders News Source has not been compensated for this report by anyone and the opinions if any are that of the author Vikas Agrawal, CFA. Author’s Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours. I, wrote this article myself, and it expresses my own opinions. I have no business relationship with any company whose stock is mentioned in the article.
This web site, published by TNS LLC, and is an investment newsletter that is built on the premise of assisting individual investors in learning about investing. Our goal as publishers of financial information is to provide research and analysis of investments to our subscribers. TNS LLC does not give buy or sell recommendations. We do purchase distribution rights from analyst, financial writers and bloggers for a fee that may be licensed to issue price targets and recommendations. Furthermore, we encourage you to speak to a licensed professional prior to making an investment in any type of publicly traded security.
We do sell advertising to other companies including brokerage firms, web sites, publicly traded issuers, investor relations firms, and investment publications, among others. TNS LLC makes no warranty as to the policies of these organizations, and in no way endorses their offers, services, or the content of their advertisements.
When an advertiser is a publicly traded company or a third party acting on behalf of a public company, we fully disclose all compensation in the email advertisement. Such disclosure is included in a disclosure statement in each of the advertisements sent via email.
Our reports/releases are a commercial advertisement and are for general information purposes ONLY. We are engaged in the business of marketing and advertising companies for monetary compensation. Never invest in any stock featured on our site or emails unless you can afford to lose your entire investment. The disclaimer is to be read and fully understood before using our services, joining our site or our email/blog list as well as any social networking platforms we may use.
PLEASE NOTE WELL: TNS LLC and its employees are not a Registered Investment Advisor, Broker Dealer or a member of any association for other research providers in any jurisdiction whatsoever.
Release of Liability: Through use of this website viewing or using you agree to hold TNS LLC, its operator’s owners and employees harmless and to completely release them from any and all liability due to any and all loss (monetary or otherwise), damage (monetary or otherwise), or injury (monetary or otherwise) that you may incur. The information contained herein is based on sources which we believe to be reliable but is not guaranteed by us as being accurate and does not purport to be a complete statement or summary of the available data. TNS LLC encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and TNS LLC makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies. None of the materials or advertisements herein constitute offers or solicitations to purchase or sell securities of the companies profiled herein and any decision to invest in any such company or other financial decisions should not be made based upon the information provide herein. Instead TNS LLC strongly urges you conduct a complete and independent investigation of the respective companies and consideration of all pertinent risks. Readers are advised to review SEC periodic reports: Forms 10-Q, 10K, Form 8-K, insider reports, Forms 3, 4, 5 Schedule 13D.
TNS LLC is compliant with the Can Spam Act of 2003. TNS LLC does not offer such advice or analysis, and TNS LLC further urges you to consult your own independent tax, business, financial and investment advisors. Investing in micro-cap and growth securities is highly speculative and carries an extremely high degree of risk. It is possible that an investor’s investment may be lost or impaired due to the speculative nature of the companies profiled.
The Private Securities Litigation Reform Act of 1995 provides investors a ‘safe harbor’ in regard to forward-looking statements. Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, goals, assumptions or future events or performance are not statements of historical fact may be “forward looking statements”. Forward looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements in this action may be identified through use of words such as “projects”, “foresee”, “expects”, “will”, “anticipates”, “estimates”, “believes”, “understands”, or that by statements indicating certain actions & quote; “may”, “could”, or “might” occur.
Understand there is no guarantee past performance will be indicative of future results. In preparing this publication, TNS LLC has relied upon information supplied by its customers, publicly available information and press releases which it believes to be reliable; however, such reliability cannot be guaranteed. Investors should not rely on the information contained in this website. Rather, investors should use the information contained in this website as a starting point for doing additional independent research on the featured companies. The advertisements in this website are believed to be reliable, however, TNS LLC and its owners, affiliates, subsidiaries, officers, directors, representatives and agents disclaim any liability as to the completeness or accuracy of the information contained in any advertisement and for any omissions of materials facts from such advertisement. TNS LLC is not responsible for any claims made by the companies advertised herein, nor is TNS LLC responsible for any other promotional firm, its program or its structure.