CARLSBAD, Calif., June 7, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII) announced today that it filed suit against Vitalize Labs, LLC (doing business as Eboost) for infringing NAI’s CarnoSyn® beta-alanine trademarks. NAI filed the suit in U.S. District Court for the Southern District of New York.
NAI owns multiple patents and trademarks covering its CarnoSyn® beta-alanine ingredient. NAI also successfully obtained NDI status from the FDA earlier this year for CarnoSyn®. The suit alleges that Vitalize represents to consumers that its pre-workout product called Pow® contains NAI’s patented CarnoSyn® beta-alanine. Vitalize’s products are sold through its website, at certain retail stores, and on Amazon.com. NAI alleges that Vitalize’s use of its registered CarnoSyn® trademarks on product labels and in advertising constitutes willful trademark infringement. Vitalize has not purchased licensed CarnoSyn® beta-alanine from NAI, nor is Vitalize authorized or licensed to use NAI’s CarnoSyn® trademarks. NAI has not entered into a trademark license agreement with Vitalize or anyone authorized to act on its behalf. NAI’s business records do not reflect that a contract manufacturer has ever purchased licensed CarnoSyn® beta-alanine from NAI for the manufacture of Eboost. Additionally, Vitalize’s unauthorized use of NAI’s trademarks causes confusion to consumers that it is purchasing a supplement with CarnoSyn®, an ingredient having NDI status with the FDA. NAI’s suit seeks damages, an injunction against continued use of its trademarks, and other relief.
Mark LeDoux, NAI’s CEO and Chairman said that “NAI has invested and continues to expend substantial funds to conduct scientific research and to build, expand and promote sales of CarnoSyn® beta-alanine.” He went on to say that “NAI pursues legal avenues to protect its CarnoSyn® brand, intellectual property portfolio and regulatory compliance status.” He noted that CarnoSyn® is the only beta-alanine that is covered by a New Dietary Ingredient Notification submission with the Food and Drug Administration (FDA) and that has Self-Affirmed GRAS (Generally Recognized as Safe) status at up to 6.4 grams per day.
On June 5, 2019, NAI announced that its CarnoSyn® beta-alanine has won NutraIngredients’ prestigious 2019 Sports Nutrition Ingredient of the Year award recognizing its major contributions to the sports nutrition industry.
About CarnoSyn® Brands:
CarnoSyn® Brands feature two clinically studied, patented ingredients available exclusively from Natural Alternatives International, Inc.: CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine. In 2019, CarnoSyn® beta-alanine successfully obtained NDI status from the FDA and received Self-Affirmed GRAS (Generally Recognized as Safe) status at up to 6.4 grams per day, enabling NAI’s brand partners to provide unique offerings in various food categories. In the sports nutrition segment, both ingredients are well known to deliver benefits for athletic performance: Increased strength, enhanced endurance, faster recovery and greater mental focus. SR CarnoSyn® is an advanced delivery form of CarnoSyn®, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging. In 2017, SR CarnoSyn® was determined to be safe through independent scientific procedures, thus satisfying the technical element of the GRAS determination. The GRAS affirmation allows NAI to broaden its product offerings beyond the sports nutrition space and focus on the broader dietary supplement and food and beverage industries, including medical and other fortified food products.
About NAI:
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please visit www.nai-online.com.
CARLSBAD, Calif., June 5, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII) today proudly announces its CarnoSyn® beta-alanine has won NutraIngredients’ prestigious 2019 Sports Nutrition Ingredient of the Year award in recognition of its major contributions to the sports nutrition industry.
Mark LeDoux, NAI CEO & Chairman, proudly accepts CarnoSyn®’s Sports Nutrition Ingredient of the Year award.
The NutraIngredients-USA Awards honor the best and brightest in ingredients, finished products, companies, people, and initiatives in the nutrition and dietary supplements industry. The judges lauded the strong suite of science backing CarnoSyn®‘s benefits. They were particularly impressed with the endpoints of the studies that related directly to sports nutrition benefits such as improved endurance, strength increases, better recovery from intensive exercise, etc., as opposed to endpoints that might be tangentially related to sport benefits, such as a high antioxidant capacity for dealing with post-exercise inflammation.
“We are honored to have received this esteemed award from NutraIngredients,” Mark LeDoux, NAI CEO & Chairman, said. “On behalf of our dedicated team, our researchers and millions of happy users, we will continue the effort to provide the most rigorous scientific support for CarnoSyn® as the only beta-alanine to receive NDI status from the FDA. Consumers should not settle for anything less than the best— CarnoSyn® beta-alanine.”
The award recognizes CarnoSyn®‘s commitment to innovation, research and performance—and comes after major strides recently made in science, safety and industry penetration.
“We are grateful for all of our brand partners and industry supporters for their on-going commitment to formulating with the highest quality, science-based ingredients for their consumers,” said Nicole Burbank, Vice President of CarnoSyn® Brands.
Over the past year CarnoSyn® has gained momentum with its expansion into the healthy aging and wellness sectors, the Japanese marketplace, and its continued efforts with the NFL athletes and Olympic hopefuls on the roster of Team CarnoSyn®.
“With a hefty scientific portfolio to substantiate the products efficacy, and blockbuster performance in the marketplace, CarnoSyn® is a very worthy winner for our Sports Nutrition Ingredient of the Year,” said Stephen Daniells, PhD, Editor-in-Chief of NutraIngredients-USA. “Congratulations to the NAI team on their success!”
About CarnoSyn® Brands:
CarnoSyn® Brands feature two clinically studied, patented ingredients available exclusively from Natural Alternatives International, Inc.: CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine. In 2019, CarnoSyn® beta-alanine successfully obtained NDI status from the FDA and received Self-Affirmed GRAS (Generally Recognized as Safe) status at up to 6.4 grams per day, enabling NAI’s brand partners to provide unique offerings in various food categories. In the sports nutrition segment, both ingredients are well known to deliver benefits for athletic performance: Increased strength, enhanced endurance, faster recovery and greater mental focus.
SR CarnoSyn® is an advanced delivery form of CarnoSyn®, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging. In 2017, SR CarnoSyn® was determined to be safe through independent scientific procedures, thus satisfying the technical element of the GRAS determination. The GRAS affirmation allows NAI to broaden their product offerings beyond the sports nutrition space and focus on the dietary supplement and food and beverage industries, including medical and other fortified food products.
About NAI:
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please visit www.nai-online.com.
About the NutraIngredients-USA Awards:
Focusing on true innovation, long-term market success and cutting-edge research, the NutraIngredients-USA Awards honor the best and brightest in ingredients, finished products, companies, people, and initiatives in the nutrition and dietary supplements industry. The NutraIngredients-USA Awards are organized by NutraIngredients-USA.com, the key news source for the functional food & beverage and dietary supplement industries. Covering scientific, regulatory and industry issues, the website offers a reference for all stakeholders in supplements and nutrition. Thanks to its blend of text, video and podcast content, the news can not only be read but also heard directly from the lips of the people making the headlines. For more information, please visit: www.nutraingredientsusaawards.com.
About William Reed:
William Reed is the publisher of NutraIngredients.com, NutraIngredients-USA.com, NutraIngredients-ASIA.com, NutraIngredients-LATAM.com, and a host of digital newsletters, publications and data sources for the food, drink and nutrition industries. As an international multi-media events company, William Reed welcomes more than 40,000 delegates to over 40 live events, conferences and exhibitions every year – on every continent. We’re the name behind some of the industry’s most influential global award programs including the International Wine Challenge and the World’s 50 Best Restaurants Awards. For more information, please visit: www.williamreed.com.
CONTACT:
Renee Michaelson, CarnoSyn® Marketing Manager, Natural Alternatives International, Inc., at 760-736-7700 or [email protected].
Headquartered in Carlsbad, California, and with clients in 39 countries, Natural Alternatives International, Inc. (NAI) engages in formulating, manufacturing, and marketing nutritional supplements for markets in the United States and internationally. The company offers private-label contract manufacturing services to companies that market and distribute vitamins, minerals, herbal products, and other nutritional supplements. It also provides strategic partnering services, such as customized product formulation, clinical studies, marketing support, international regulatory and label law compliance, international product registration, packaging in multiple formats, labeling design, scientific research, customer-specific nutritional product formulation, product testing and evaluation, packaging and delivery system design, and regulatory review.
Recently, Business View Magazine spoke with NAE’s Founder and CEO, Mark LeDoux, and engaged in a wide-ranging discussion about his company and the natural products sector, in general. The following is an edited transcript of that conversation.
BVM: Can you talk about the genesis and evolution of NAI? LeDoux: “I started my company in my garage, back in 1980. My sole reason for starting it was because I recognized that modern medicine was running into a buzz saw with pharmaceutical compounds that were being synthesized and were causing unnecessary side effects in people and creating, sometimes, more problems than benefits.
“And so, I made it a personal mission to start identifying what are the natural alternatives to dangerous drugs that might help the body heal itself; not to replace medicine, but to allow the human immune system to operate more efficiently by giving the necessary nutrients to the human body so that this miraculous thing could address whatever issues it needed to in order to either repair itself or to improve health.
“Obviously, this doesn’t replace medical intervention when people have significant diseases and/or broken bones, or heart attacks, or things of that nature, which require immediate attention. I was really focusing on those areas where people have consistent problems – whether it’s allergies, difficulty sleeping, or joint discomfort or pain that comes with repetitive motion or too much exercise or too much laborious work, and things of that nature.
“The first thing that we looked at was: What can you give the human body to help itself reduce the histamine reaction to allergies? So, we did a lot of work analyzing what our forebears did. What did the American Indians utilize if they ended up with a cold or flu? You start looking at the herbal pharmacopeia and you see there are all kinds of different herbals and tinctures that they successfully deployed. And then we looked at chemistry – the presence of Vitamin C, for example, that might help in the uptake of these compounds.
“This is not inconsistent with what pharma has done in years past – they looked at what’s in nature. That’s how aspirin came about. Aspirin has been considered the ‘wonder drug’ of modern life. Salicylic acid, which is the active compound of aspirin, was extracted from the bark of the white willow tree, which was used as a tea or chewed on by the North American Indians, particularly in the northeast, and it was very effective. And so, a German scientist by the name of Friedrich Bayer was able to isolate the compound and, voila, you end up with aspirin.
“This is true of multiple indications. So, I really started with a noble focus: to try and identify what’s in nature that we could either encapsulate, or compress into a tablet and give to people to support their own body’s systems that would not do injury, but provide nutritional support for improving human health.
“So, that’s how the business got started, and a couple of years after I started it, I was having other people manufacture products for us and our distribution channels were largely through health food retailers, and some clinicians – osteopaths, medical doctors, and others who were looking for natural remedies to give to their patients, along with whatever other interventions they were doing, and the business grew quite dramatically.”
BVM: What is the state of the company, today? LeDoux: “We have about 80 employees working for us in our roughly 100,000-sq.-ft. manufacturing facility in Lugano, Switzerland, servicing the needs of Asia, Europe and the Middle East. We have about 180,000 square feet of manufacturing in Vista, California, in northern San Diego County. Our corporate offices are located in Carlsbad, which is the neighboring community of Vista. We have about 200 people working in the U.S., including sales, research, production, procurement, analytical testing, etc. And then, we also have a sales office in Yokohama, Japan, which services the unique needs of Japan and the Far East. So, there are almost 300 people working for us around the globe, and our revenues last year were just over $130,000,000. We’re entering, now, our 39th year of operations, which is extremely gratifying.”
BVM: Can you talk about the company’s product lines – both your own and that of others? LeDoux: “Our emphasis has not been as much on our own product as it has been becoming a preferred contract supplier for major corporations, both domestic and international. So, most of our volumes, today, are making other people’s products to very exacting international standards of excellence. Our U.S. facilities have multiple certifications, not only from U.S. entities, but also some very difficult certifications to achieve and maintain from outfits like the Therapeutic Goods Administration of Australia, which opens access to about 48 different international markets on a preferential basis.
“Our Swiss facilities have multiple licensures, as well, including a pharma license from the Swissmedic entity in Bern, which is sort of equivalent to the FDA (Food and Drug Administration) in the United States. So our focus has largely been on contract manufacturing for large, multi-national companies. We also have a division where we mine our intellectual property with our own product known as CarnoSyn, which is multiple-patented amino acid for a variety of markets – sports nutrition, nutrition for the elderly, and healthcare practitioner markets. That represents about 15-20 percent of our marketplace and contract manufacturing represents between 80 and 85 percent.”
BVM: How does NAI differentiate itself from its competitors? LeDoux: “For starters, we reinvest our profits in our company in terms of capital equipment and in human resources. We also put our money into primary research. We’re a debt-free company with almost $30 million in cash and all the tangible assets we have, which are probably north of $60 or 70 million, are all paid for. And so, recognizing that labor is a significant component of our competitors’ profit and loss statements, we focus on high-speed equipment that is largely automated that will allow us to do extraordinary throughput on a consistent, quality basis, keeping our direct labor costs at between five and six percent of our finished product cost – which is extraordinary.
“We also believe that ‘Made in Switzerland’ and ‘Made in America’ has tremendous caché for many international markets, and that’s been borne out by seeing the rapid growth that we’ve experienced in key markets around the world. Consumers are very concerned about product efficacy and safety, and they gravitate to companies like NAI because of our exemplary record of product integrity, not to mention our multiple licensures, independent testing, and independent validation of our efforts. We’re not always the cheapest (and we take great pride in not being the cheapest) but we have the most valueadded and properly-priced products in the marketplace.
“So, we think that there’s intrinsic value in that and, if you’re on the other side of the equation, and you’re a company with a brand, and you’d like to protect its integrity, who would you prefer to do business with – a start-up firm, a firm that’s been leveraged by private equity with significant debt servicing requirements, or a business with a company that’s almost 40 years old, is debt-free, and with adequate cash in the bank to make the appropriate investments in either capital equipment or research in order to bring even additional value to your product?
“I think the proof is in the pudding. People are coming here because they want to sleep well at night and they don’t want to second guess whether their supplier is playing games or not. And that doesn’t happen here, so that’s a positive thing.
“As to who our competitors are: there are a lot of companies engaged in manufacturing products. Some have one channel – they’re big in powder development; others may be big in tablet or chewable development; or in encapsulation. We do all the above, so we’re kind of a one-stop-shop. Again, in terms of public companies that are really competitors to ours – there aren’t really many left; I think we’re kind of the only pure play left in this space, and if you look at our balance sheet, it’s about as pristine as you can imagine.”
BVM: What are some of the most pressing and current issues in the natural products sector? LeDoux: “I’ve been privileged to serve as the Chairman of the Board of the Natural Products Association (NPA), which is over 80 years old, and represents the natural products industry in the United States, of which there are thousands and thousands of members. I was just at the White House with several colleagues, and seated at the table with me were representatives of multi-billion dollar corporations. The concerns that we expressed at the White House regarded the need to manage this situation of tariffs with China and others, more judiciously. There’s no question, if you’re going to take a hard look at how certain countries do their trade, that the United States has been taken advantage of. But to put blanket tariffs on single-source suppliers without looking at how we stand up as suppliers that can do the same product in the United States, I think is just a wee bit short-sighted. There are other opportunities, I think, to pursue freer and fairer trade. But we’ll see what the administration comes back with; I’m hopeful that the Chinese and the U.S. government will sit down and work on something that truly is fair and colleagues, and seated at the table with me were representatives of multi-billion dollar corporations. The concerns that we expressed at the White House regarded the need to manage this situation of tariffs with China and others, more judiciously. There’s no question, if you’re going to take a hard look at how certain countries do their trade, that the United States has been taken advantage of. But to put blanket tariffs on single-source suppliers without looking at how we stand up as suppliers that can do the same product in the United States, I think is just a wee bit short-sighted. There are other opportunities, I think, to pursue freer and fairer trade. But we’ll see what the administration comes back with; I’m hopeful that the Chinese and the U.S. government will sit down and work on something that truly is fair and balanced. So that’s a front-burner issue, because it is impacting the cost of goods for everyone.
“There are some other front burner issues. We’ve been working very closely with the Food and Drug Administration to try and identify those products that are being sold that are illegal, per se, in the United States. The FDA has a tough job to do because it has to enforce all types of regulations across a panorama of foods and drugs. But we’re trying to get them more resources and get them focused on taking some low-hanging fruit out of the marketplace so that responsible companies can enter the fray with products that are made according to the good manufacturing practices that are on the books.
“There are too many people that are getting into the business, claiming that their products are dietary supplements, but they’re either knowingly, or naively, including active pharmaceutical ingredients and not disclosing those. There are a lot of internetpurveyors of products that seem to turn a blind eye towards the regulatory and oversight requirements. And those present an enormous risk to the public. So the NPA is working with the FDA and others to try and identify these products and get them seized at the border or, to stop production in the United States through a judicious application of regulatory oversight. And in our discussions with the Federal Trade Commission (FTC) and the FDA, and Health and Human Services, those are some pretty significant issues that I think the administration needs to deal with. But, again, they’re resource-constrained, the business, claiming that their products are dietary supplements, but they’re either knowingly, or naively, including active pharmaceutical ingredients and not disclosing those. There are a lot of internetpurveyors of products that seem to turn a blind eye towards the regulatory and oversight requirements. And those present an enormous risk to the public. So the NPA is working with the FDA and others to and to the extent that we can get more resources so that they can pursue their stated objectives and what they’re supposed to do, I think it will benefit the consumers and the industry at large.”
BVM: What’s the long-term outlook for NAI? Le Doux: “I think the demographics are on our side and the science is on our side. We have an enormous cost for medical care in the United States, as well as places like Europe, which both have aging demographics; the same is very true for Japan. Then, you look at some of the younger marketplaces where demographics are the flip of what they are in North America. For example, if you look at Vietnam, Malaysia, Indonesia, Australia – you have a younger demographic. And all these people are starting to understand the real value of natural products in their daily lives. So, I think there will be significantly larger markets. I also think that our company will be two or three times its size within five years, assuming we can grow organically as well as through judicious acquisitions.
“We like the healthcare practitioner space. We think that area is ripe for consolidation and growth. More and more people are looking for natural alternatives to drugs – even doctors are looking for that. Look at the non-judicious use of antibiotics – we’re running out of magic bullets. Somebody has a runny nose and their doctor gives them an antibiotic. That’s great, but these bugs are smarter than the antibiotics, so they’ll mutate into something that we don’t have an arsenal, currently, to address. So, we need to back up for a minute and realize that not everything has a magic bullet. Let’s try and nourish the human immune system with things that will actually create a better line of defense than overusing antibiotic therapies.
“So, more and more doctors are relying on natural products as part of their therapies and they’re demonstrating some really good results. You look at life cycles; not a hundred years ago, life expectancy was 20 years less than what it is today. Five years from now, I think life expectancy will morph out another year or two. People born in 2023 will probably live a hundred years unless they’re killed in an accident or through some other unfortunate event. So, we’re getting better and better in our scientific approach.”
BVM: Any final thoughts you’d like to leave with our readers? LeDoux: “We have a history, over the last 70 to 80 years in our country, of attacking symptoms versus attacking root causes and as the science evolves and companies like us and our colleagues make investments in the research, we’re going to start unlocking some of the mysteries of why things happen the way they do. As long as we maintain our heads about us and apply the scientific method, we’re going to be at the table with those seminal discussions that take place in Washington and elsewhere about what healthcare will look like 20 or 30 years from now. Are we part of the solution to explosive healthcare costs? I would humbly suggest, yes.
“I also think that one of the reasons that people gravitate towards us is because the consumer is coming – not only in North America, but around the world. There’s been somewhat of a breach of trust that has taken place over the last several decades between companies that are saying, “Trust me, this is great,” and then the end result maybe being not so great. And the consumer, with access to the internet, access to information and research, is becoming much more knowledgeable, much more inquisitive, and justifiably skeptical. So, they’re doing their homework before they make purchase decisions. And it’s incumbent for us to continue to make those appropriate investments in answering the questions that consumers have: Is this product beneficial for me and my family? What will it do? How does it work? And how can you make sure that the sources work? And how can you make sure that the sources work? And how can you make sure that the sources from which you bring this product to market remain sustainable for the globe that we live on?
So, with that approach, our focus is to enrich the world with the best of nutrition, and we are driven to exceed our customers’ expectations – not only our customers who are clients, but their consumers, as well. So, those are the precepts that guide us and have given us a very solid path forward.”
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CARLSBAD, Calif., May 14, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII) today announced its participation, partnering with NAI’s exclusive distributor, Shimizu Chemical Corporation, in the 24th edition of the ifia® Japan, The International Food Ingredients & Additives Exhibition and Conference—Asia’s largest event dedicated to food ingredients, additives and the health food sector. More than 32,000 international industry professionals are expected to attend this three-day event held on May 22-24, 2019, at the Tokyo Big Sight in Tokyo, Japan.
In March 2019, the Ministry of Health, Labor and Welfare of Japan announced the approval of beta-alanine in the Japanese food market—NAI was instrumental in this premier achievement after spending nearly three years navigating the application process. In effort to introduce CarnoSyn® beta-alanine, the only beta-alanine to receive New Dietary Ingredient Status from the FDA, to the Japanese market, NAI is leveraging ifia® as a major platform.
CarnoSyn® Brands will be exhibiting at booth SN009 as well as conducting two presentations: the first, held at 11:30 – 12:15 PM on May 22, will introduce CarnoSyn® beta-alanine and details around the newly-obtained NDI Status and global patents; the second, held from 9:00 – 11:45 AM on May 23, will expand into CarnoSyn®‘s scientifically-proven benefits in sports nutrition, and SR CarnoSyn®‘s use for healthy aging and wellness.
“We are dedicated to supporting the beta-alanine needs of the Japanese market,” CarnoSyn® Brands Vice President, Nicole Burbank said. “CarnoSyn beta-alanine is globally recognized as a patented, high-quality ingredient of choice among companies wishing to use only the safest ingredients in their products—and we look forward to continuing our aggressive business and educational efforts in the Japanese marketplace.”
Recently, Dr. Di Tan, Director of Scientific Affairs for CarnoSyn®, attended the Health Food Expo, April 9 – 10, 2019 in Tokyo, Japan where CarnoSyn®‘s presentations were fully attended and the exhibiting space generated vast interest and business opportunities.
“After tremendous success at the Health Food Expo last month, we are looking forward to exhibiting and presenting at the largest food ingredient event in Asia—ifia® Japan,” Dr. Di Tan said. “We look forward to sharing our massive strides in science, patents and regulations while continuing our efforts to penetrate the Japanese market.”
About CarnoSyn® Brands:
CarnoSyn® Brands feature two clinically studied, patented ingredients available exclusively from Natural Alternatives International, Inc.: CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine. In 2019, CarnoSyn® beta-alanine successfully obtained NDI status from the FDA and received Self-Affirmed GRAS (Generally Recognized as Safe) status at up to 6.4 grams per day, enabling NAI’s brand partners to provide unique offerings in various food categories. In the sports nutrition segment, both ingredients are well known to deliver benefits for athletic performance: Increased strength, enhanced endurance, faster recovery and greater mental focus.
SR CarnoSyn® is an advanced delivery form of CarnoSyn®, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging. In 2017, SR CarnoSyn® was determined to be safe through independent scientific procedures, thus satisfying the technical element of the GRAS determination. The GRAS affirmation allows NAI to broaden their product offerings beyond the sports nutrition space and focus on the dietary supplement and food and beverage industries, including medical and other fortified food products.
About NAI:
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please visit www.nai-online.com.
About Shimizu Chemical Corporation:
Shimizu is a leading company in nutritional sciences in Japan, offering a wide range of products and services in various industries from pharmaceuticals and foods to cosmetics and sports nutrition. With its unique solutions and long-standing expertise, Shimizu continues to innovate globally. Its services include managing and leading contract manufacturing services to fulfill a variety of customer needs to produce finished products containing CarnoSyn® beta-alanine in a variety of forms, from nutritional supplements to all types of food products.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our future revenue profits and financial condition, our ability to maintain our patents, generate revenues from the commercialization of our patents and trademarks, secure compliance with our intellectual property rights, and develop, maintain or increase sales to new and existing customers, as well as future economic conditions and the impact of such conditions on our business. We wish to caution readers that these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks, including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.
CONTACT:
Renee Michaelson, CarnoSyn® Marketing Manager, Natural Alternatives International, Inc., at 760-736-7700 or [email protected].
Takuya Ono, CarnoSyn® Sales Manager, Shimizu Chemical Corporation, at +81-848-68-0371 or [email protected]
CARLSBAD, Calif., May 9, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII), a leading formulator, manufacturer and marketer of customized nutritional supplements, today announced net income of $6.7 million, or $0.95 per diluted share, on net sales of $108.0 million for the nine months ended March 31, 2019.
Net income for the nine months ended March 31, 2019 was $6.7 million, or $0.95 per diluted share, compared to net income of $2.2 million, or $0.32 per diluted share, for the nine months ended March 31, 2018. The previous period’s results were unfavorably impacted by one-time discrete tax expense amounts recorded in connection with the 2017 U.S. Tax Act. These one-time charges totaled $3.3 million, or approximately $0.47 per diluted share. Excluding these discrete tax items, our adjusted net income during the nine months ended March 31, 2018 was $5.4 million, or $0.79 per diluted share.
Net sales during the nine months ended March 31, 2019 increased $14.8 million, or 16%, from $93.2 million recorded in the comparable prior year period. For the nine months ended March 31, 2019, private label contract manufacturing sales increased $17.3 million, or 22%, from the comparable period last year. Third quarter contract manufacturing sales increased primarily due to the sale of new products to new and existing customers and higher volumes of current products to existing customers.
CarnoSyn® beta-alanine royalty, licensing and raw material sales revenue during the first nine months of fiscal 2019 were $13.5 million which decreased 15%, from $16.0 million recorded in the comparable prior year period. Our CarnoSyn® beta-alanine business has experienced a slowdown in sales during fiscal 2019 primarily as a result of various brands electing to switch their CarnoSyn® beta-alanine purchases to generic beta-alanine. We expect the recent ruling from the U.S. Court of Appeals for the Federal Circuit in favor of NAI’s CarnoSyn® beta-alanine patents, concluding “patent eligibility” under existing law, along with our CarnoSyn® beta-alanine New Dietary Ingredient (NDI) status from the FDA, will help motivate departed brands and contract manufacturers to purchase CarnoSyn® in the future.
Net income for our third quarter of fiscal 2019 was $2.0 million, or $0.27 per diluted share, compared to a net income of $2.1 million, or $0.30 per diluted share, in the third quarter of fiscal 2018.
Net sales during the three months ended March 31, 2019 increased $3.6 million, or 11%, from $31.8 million recorded in the comparable prior year period. For the quarter ended March 31, 2019, private label contract manufacturing sales increased $6.1 million, or 24%, from the comparable quarter last year. Third quarter contract manufacturing sales increased primarily due to the sale of new products to new and existing customers and higher volumes of current products to existing customers.
CarnoSyn® beta-alanine royalty, licensing and raw material sales revenue decreased 40% to $3.7 million during the third quarter of fiscal 2019, as compared to $6.2 million for the third quarter of fiscal 2018. The decrease in CarnoSyn® revenue was primarily due to decreased material shipments and lower average sales prices.
As of March 31, 2019, we had cash of $27.7 million and working capital of $58.1 million compared to $23.6 million and $50.9 million, respectively, as of June 30, 2018. As of March 31, 2019, we had $10.0 million available under our line of credit agreement.
Mark A. LeDoux, Chairman and Chief Executive Officer stated, “Our contract manufacturing business continues to grow through renewed interest from a variety of large companies and this bodes well for our continued strategy to achieve growth in sales and profitability in the years ahead.
Additionally, we also expect to generate new CarnoSyn® beta-alanine sales during our fourth quarter as we enter the recently opened Japanese market and launch SR CarnoSyn® in the Healthy Aging and Wellness distribution channels during early fiscal 2020.”
Reconciliation of Non-GAAP Information
The GAAP results contained in this press release and the financial statement schedules attached to this press release have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). In addition to the Company’s results prepared in accordance with GAAP, the Company provided information on a non-GAAP basis. The manner in which this non-GAAP information is derived is discussed below, and the Company has provided in the tables to this release a reconciliation of the non-GAAP information to the most directly comparable GAAP information.
Net Income and EPS Adjusted for Non-Recurring Tax Expense. In order to make the fiscal year 2018 results comparable to fiscal year 2019, we have presented net income and EPS for the three and nine months ended March 31, 2018 on a non-GAAP basis by excluding discrete tax items of $3.3 million related to the 2017 U.S. Tax Act for both the three and nine month periods. The following is a schedule reconciling our Adjusted Net Income and EPS to our GAAP Net Income and EPS.
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. Our comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please see our website at http://nai-online.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, future acquisitions, revenue profits and financial condition, our ability to maintain our patents, generate revenues from the commercialization of our patents and trademarks, secure compliance with our intellectual property rights, and develop, maintain or increase sales to new and existing customers, as well as future economic conditions and the impact of such conditions on our business. We wish to caution readers that these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks, including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.
CONTACT – Michael Fortin, Chief Financial Officer, Natural Alternatives International, Inc., at 760-736-7700 or [email protected].
CARLSBAD, Calif., May 2, 2019 – CarnoSyn® Brands, a division of Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII), and one of the world’s leading sports performance ingredients, is proud to announce NFL Draft results for Team CarnoSyn® sponsored athletes, which includes first round NFL Draft pick—Darnell Savage. In January, CarnoSyn® Brands partnered with TEST Football Academy and Kaged Muscle® to provide NFL hopefuls with a scientifically-proven edge over the competition, working together to supplement the elite NFL Combine training athletes with a full line of products containing a combined average of 10.4g per day of CarnoSyn® and SR CarnoSyn® beta-alanine.
Darnell Savage, Round 1, Pick 21 – Green Bay Packers
After a trade with the Seattle Seahawks from pick 30, the Green Bay Packers selected Maryland safety Darnell Savage with the 21st overall pick and became the first Defensive Back of the 2019 NFL Draft to come off the board. After a successful NCAA career scouts predicted Savage to be drafted in rounds 3-4. Determined to elevate his stock, Savage focused on training at TEST Football Academy to make improvements in his speed, strength and lower body explosiveness. His hard work paid off after a strong showing at the NFL Combine, where he displayed the second fastest 40 time at his position (4.36) and rapidly moved up the draft board since that moment. Savage powers his training and fuels recovery with a mix of CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine, averaging 8g per day, every day.
“CarnoSyn® allows me to compete at the highest level every day, with no sore days. It keeps my body feeling good,” Savage stated during his NFL Combine training program at TEST Football Academy. In just 30 days, Savage experienced an incredible transformation, resulting in 2.4 pounds of fat loss and a lean body mass gain of 10 pounds, for a total body composition swing of 12.4 pounds.
Foster Moreau, Round 4, Pick 137 – Oakland Raiders
With the 137th pick overall, the Raiders selected LSU tight end Foster Moreau, making Moreau the highest-selected LSU tight end since Harold Bishop was drafted in 1994 by the Tampa Bay Buccaneers. Moreau earned a reputation in college football’s most elite conference as a devastating blocker with consistently reliable hands. Moreau had an impressive Senior Bowl being named offensive player of the week and dominated his NFL combine performance by running a blazing 4.66 in the 40-yard dash that placed him top five among tight ends at the NFL combine. His 36.5-inch vertical leap tied for third, 22 bench press reps tied for second, and his time of 4.11 seconds in the 20-yard shuttle was the fastest of anyone at his position.
During the rigors of Moreau’s combine training, he quickly realized improvements in endurance, strength and focus. “With CarnoSyn®, I can work harder, faster and stronger. It helps me be more consistent and more prepared to take on the day,” Moreau said at the height of his training, nutrition and supplementation program at TEST Football, which culminated in 7.5 pounds of fat loss and a lean body mass gain of 7.6 pounds, for a total body composition swing of 15.1 pounds. Moreau’s supplement stack includes a combination of CarnoSyn® and SR CarnoSyn®, dosing 11.2g on training days and 9.6g on recovery days.
Tuzar Skipper, NFL Prospect
Tuzar Skipper created several opportunities for himself and received wanted attention by displaying his raw strength, speed and explosiveness at his Pro Day. After the draft, he was invited to an NFL minicamp with the Kansas City Chiefs and a CFL minicamp with the Hamilton Tiger Cats. Skipper overcame adversity to earn a starting role on Toledo’s renowned defense and looks to use that opportunity to continue his pursuit of his NFL dream. While at TEST Football, Skipper committed himself to dominate the training process and catapult himself to the next level, incorporating CarnoSyn® and SR CarnoSyn® into his supplementation regimen, dosing 11.2g on training days and 9.6g on
recovery days.
Skipper stated, “Without CarnoSyn®, I would not be able to hit the numbers that I hit, especially with the bench press—going from 19 to 26 reps in 28 days.” Adding 12.6 pounds of lean body mass, Skipper became stronger, faster and more explosive than he’s ever been. In 30 days, his transformation included a fat loss of 3.7 pounds and a total body composition swing of 16.3 pounds.
“We couldn’t be more proud of the players that put in all the work to make their dreams become a reality,” exclaimed Kevin Dunn, TEST Football Academy Owner and CEO. “Darnell Savage becoming a first round draft pick to the Green Bay Packers was an epic moment that was the icing on the cake of TEST Football’s 20 year anniversary. The excitement continued by seeing Foster Moreau selected in the fourth round to the Oakland Raiders and Tuzar Skipper getting multiple minicamp offers in both the NFL and the CFL. All this followed by 15 more TEST Football Academy alumni signing as priority free agents or minicamp invites—18 players in all. We can’t thank our army of supporters enough for their contributions during this process. When results are truly on the line, we leave no stone unturned when it comes to our athletes as we research the most scientifically advanced options our industry has to offer to support their mindset, movement, recovery and nutrition goals. A huge thank you to CarnoSyn® and Kaged Muscle for banned substance free products that have become a staple we can trust at the highest level.”
“CarnoSyn® is proud to sponsor these three elite athletes, chronicling their inspirational journeys through video and social media, to build brand awareness and foster education on the efficacious loading and dosing of CarnoSyn® and SR CarnoSyn® beta-alanine,” stated Nicole Burbank, Vice President of CarnoSyn® Brands. “For the second year in a row, we’ve witnessed impressive athlete transformations, with this year’s NFL Combine class of 35 athletes collectively losing 233 pounds of fat and gaining a total lean body mass of 237 pounds—for a total body composition swing of 470 pounds. We’re proud to play a crucial role in these outcomes.”
About CarnoSyn® Brands:
CarnoSyn® Brands feature two clinically studied, patented ingredients available exclusively from Natural Alternatives International, Inc.: CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine. In 2019, CarnoSyn® beta-alanine successfully obtained NDI status from the FDA and received Self-Affirmed GRAS (Generally Recognized as Safe) status at up to 6.4 grams per day, enabling NAI’s brand partners to provide unique offerings in various food categories. In the sports nutrition segment, both ingredients are well known to deliver benefits for athletic performance: Increased strength, enhanced endurance, faster recovery and greater mental focus.
SR CarnoSyn® is an advanced delivery form of CarnoSyn®, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging. In 2017, SR CarnoSyn® was determined to be safe through independent scientific procedures, thus satisfying the technical element of the GRAS determination. The GRAS affirmation allows NAI to broaden their product offerings beyond the sports nutrition space and focus on the dietary supplement and food and beverage industries, including medical and other fortified food products.
About NAI:
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please visit www.nai-online.com.
About TEST Football Academy:
TEST Football Academy has been training football players at all levels since 1999, marking 2019 as its 20th anniversary. Over that tenure, they have assembled the most experienced, world class team ever to prepare collegiate NFL prospects for the NFL Combine and Pro Days. They also work with youth and high school athletes, helping ballers of all ages get to the next level. This team of professionals consists of prominent performance coaches, international speed consultants, Super Bowl champions, pro bowlers, medical experts, sports psychologists, nutrition counselors, massage therapists, media personalities and interview prep professionals.
TEST Football Academy is the result of Owner and CEO, Kevin Dunn, Director of Football Operations, Geir Gudmundsen and a team professionals with over a century of collective experience, having worked with nearly 400 pro athlete hopefuls over two decades, with a success rate of more than 250 athletes who have gone on to play professional football. They prepare athletes for the NFL Combine, Pro Days and help to extend NFL careers with consistent follow-up and coaching in the off season year after year. No longer does an athlete have to accept one trainer when they can have an entire team of experts supporting them on the most important journey of their lives with the potential to earn generational income.
About Kaged Muscle:
Kaged Muscle® is an award winning, ultra-premium sports nutrition line and lifestyle brand, created to help athletes and fitness enthusiasts of all levels reach their transformation goals. Headquartered in Huntington Beach, California, KM is a rapidly growing producer of innovative, high-quality products in the sports nutrition category. Earning top accolades in 2017 and 2018 for their flagship products, Pre-Kaged®, In-Kaged® and Kasein®, from sports nutrition retail giants Bodybuilding.com, GNC and Vitamin Shoppe, KM’s award-winning line has quickly become an industry leader for clean, premium quality products and the brand consumers can trust.
Formulated with research-backed premium quality and patented ingredients, each and every KM product undergoes rigorous in-lab development and testing as well as real-world use in the gym by top athletes, to ensure their quality and effectiveness. KM’s commitment to providing athletes of all levels with premium, safe, science-backed sports nutrition products sets the brand apart from many of its competitors. The comprehensive line of sports nutrition products is third party tested for purity and potency, contains no artificial colors or flavors, no synthetic caffeine, fermented and vegan-sourced amino acids, and is certified free of banned substances by Informed-Choice and Informed-Sport. In addition to offering premium quality products, KM also provides consumers with an array of powerful resources, including hundreds of articles, videos and online trainers, to help educate and guide them on their journey to better health and performance.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our future revenue profits and financial condition, our ability to maintain our patents, generate revenues from the commercialization of our patents and trademarks, secure compliance with our intellectual property rights, and develop, maintain or increase sales to new and existing customers, as well as future economic conditions and the impact of such conditions on our business. We wish to caution readers that these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks, including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.
###
SOURCE: Natural Alternatives International, Inc.
CONTACT:
Renee Michaelson, CarnoSyn® Marketing Manager, Natural Alternatives International, Inc., at 760-736-7700 or [email protected].
NAI to Immediately Enter Japanese Market with CarnoSyn® Beta-Alanine
CARLSBAD, Calif., April 24, 2019 – The public announcement of the approval of beta-alanine in the Japanese food market was made on March 25th via the official page of the Ministry of Health, Labor and Welfare of Japan. Natural Alternatives International, Inc. (“NAI”) (Nasdaq: NAII), a leading formulator, and marketer of customized nutritional supplements, spent nearly three years navigating the application process and was instrumental in this premier achievement.
“NAI applied to the Ministry of Health, Labor and Welfare for use of beta-alanine in food products in the Japanese marketplace. We received application confirmation in May 2016 and have worked diligently since that time to gain approval. We are proud to have provided assistance in opening the market and in ultimately gaining beta-alanine approval as a food ingredient in Japan for the first time,” stated Ken Wolf, NAI’s President. “NAI looks forward to entering the market with its CarnoSyn® beta-alanine, the only beta-alanine to receive New Dietary Ingredient Status from the FDA in the United States.”
With the March 25th passing of proposal number 495180287, NAI fully intends to support Japanese market needs by participating in key 2019 industry tradeshows and conferences. Dr. Di Tan, Director of Scientific Affairs for CarnoSyn®, recently attended the Health Food Expo, April 9-10, and will attend two additional conferences in Tokyo over the coming months: the IFIA and HEF International Food Ingredients & Additives Exhibition and Conference, May 22-24, and the Sportec and Health Fitness Japan exhibition, July 9-11.
“CarnoSyn® beta-alanine is widely recognized as a patented, high-quality ingredient of choice among companies wishing to use only the safest ingredients in their products. Our CarnoSyn® beta-alanine is available for sale immediately in Japan to support our efforts in the Japanese market,” noted Nicole Burbank, Vice President of CarnoSyn® Brands.
NAI is partnering with Shimizu Chemical Corporation to provide exclusive distribution of CarnoSyn® beta-alanine in Japan. Shimizu is a leading company in nutritional sciences in Japan, offering a wide range of products and services in various industries from pharmaceuticals and foods to cosmetics and sports nutrition. With its unique solutions and longstanding expertise, Shimizu continues to innovate globally. Its services include managing and leading contract manufacturing services to fulfill a variety of customer needs to produce finished products containing CarnoSyn® beta-alanine in a variety of forms, from nutritional supplements to all types of food products.
“We are committed to supporting NAI and promoting CarnoSyn® beta-alanine in the newly opened Japanese marketplace”, said Ryusuke Shimizu, President and COO of Shimizu Chemical Corporation. “In addition to our 20+ year relationship with NAI, we are confident we can leverage our knowledge and expertise within Japan and beyond to create a successful market expansion and cultivate new customer partnerships.”
About CarnoSyn® Brands:
CarnoSyn® Brands feature two clinically studied, patented ingredients available exclusively from Natural Alternatives International, Inc.: CarnoSyn® instant release beta-alanine and SR CarnoSyn® sustained release beta-alanine. In 2019, CarnoSyn® beta-alanine successfully obtained NDI status from the FDA. In the sports nutrition segment, both ingredients are well known to deliver benefits for athletic performance: Increased strength, enhanced endurance, faster recovery and greater mental focus.
SR CarnoSyn® is an advanced delivery form of CarnoSyn®, which delivers higher dosing levels of beta-alanine, and is proven to provide benefits for both wellness and healthy aging. In 2017, SR CarnoSyn® was determined to be safe through independent scientific procedures, thus satisfying the technical element of the Generally Recognized as Safe (GRAS) determination. The GRAS affirmation allows NAI to broaden their product offerings beyond the sports nutrition space and focus on the dietary supplement and food and beverage industries, including medical and other fortified food products.
About NAI:
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to our clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please visit www.nai-online.com.
This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934 that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our future revenue profits and financial condition, our ability to maintain our patents, generate revenues from the commercialization of our patents and trademarks, secure compliance with our intellectual property rights, and develop, maintain or increase sales to new and existing customers, as well as future economic conditions and the impact of such conditions on our business. We wish to caution readers that these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks, including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K.
CARLSBAD, Calif., April 4, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (NASDAQ:NAII), a leading formulator, manufacturer and marketer of customized nutritional supplements, is proud to announce that it has further extended its partnership with The Juice Plus+ Company (“Juice Plus+“), a globally recognized leader in whole-food based nutritional products focused on people’s health and well-being, through the execution of an amendment to and a three year extension of its multi-year Exclusive Manufacturing Agreement covering Juice Plus+ capsule and powder products sold in over 24 markets around the world.
The effective date of the Amended and Restated Exclusive Manufacturing Agreement is March 31, 2019. As part of the extension, Juice Plus+ will receive a cash based discount during the remaining term of the original agreement, and subject to minimum annual purchases by Juice Plus+ an additional cash based discount during the extended period of the agreement.
Mark A. LeDoux, NAI’s CEO and Chairman of the Board, said, “Extending our quarter of a century partnership makes abundant sense given our continued emphasis on producing the highest quality nutritional products backed by an impressive body of scientific research. Both parties continue to invest in ongoing efforts to reinforce the health-promoting properties of the JuicePlus+ family of products. This strategic extension of our supply agreement provides economic incentives to both parties to redouble those efforts.”
Paulo L. Teixeira, Juice Plus+ CEO, said, “We are very pleased with our commercial relationship with NAI. Their commitment to quality, innovation and our global expansion plan has been impressive and consistent, and this contract extension recognizes the value of continuing these mutual efforts, and we are confident that this extension will be mutually beneficial.”
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to NAI’s clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please see its website at http://nai-online.com.
This press release contains forward-looking statements within the meaning of applicable securities laws that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our expectations and beliefs with respect to the impact of this Agreement on our manufacturing capacity, and our annual sales. We wish to caution readers these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
CONTACT – Kenneth Wolf, President and Chief Operating Officer, Natural Alternatives International, Inc., at 760-736-7700 or [email protected].
A victory for Natural Alternatives International in its beta alanine patent case is being heralded as a huge IP protection precedent in the natural products industry. More>
CARLSBAD, Calif., March 19, 2019 /PRNewswire/ — Natural Alternatives International, Inc. (“NAI”) (NASDAQ: NAII), a leading formulator, and marketer of customized nutritional supplements announced today that the U.S. Court of Appeals for the Federal Circuit has ruled in NAI’s favor, holding that its CarnoSyn® beta-alanine patents are “patent eligible” under existing law. The Court’s decision reverses a 2017 ruling by a California district court and revives important patent rights in NAI’s existing patent portfolio.
The Federal Circuit disagreed with the lower court, concluding a dietary supplement may be patented despite being based on a naturally occurring substance, and ordered the case to be remanded back to the lower court to move forward on NAI’s infringement claims against the original defendant.
Mark A. LeDoux, NAI’s CEO and Chairman of the Board, said that “NAI has always been confident that the Federal Circuit — which has particular expertise in patent law — would look at the body of science NAI put into the record, properly apply the law, and find NAI’s patents are valid. That is what the Federal Circuit did in issuing its fact-based and carefully reasoned decision. As it has consistently done, NAI will continue to vigorously enforce its intellectual property rights.”
He went on to say that “The Court’s decisive ruling is very significant to the dietary supplement industry, not just NAI.” LeDoux, who is also the Chairman of the Natural Products Association, said that “The Court’s ruling means members of the supplement industry can and should continue to avail themselves of U.S. patent laws as well as regulatory tools, such as NDIs, to protect their significant investments in clinical research, product development, substantiation and testing for innovative products and uses that benefit consumers every day.”
NAI’s CarnoSyn® beta-alanine is widely-recognized as a patented, high-quality ingredient of choice among companies wishing to use the safest ingredients in their products. NAI has invested millions of dollars over the years in its CarnoSyn® beta-alanine brand, including research, development, clinical trials, marketing, intellectual property protection and regulatory compliance. On February 19, 2019, NAI announced that it received New Dietary Ingredient (NDI) status from the Food and Drug Administration (FDA) for its CarnoSyn® beta-alanine ingredient at a total daily intake level of 6.4 grams per day. NAI received the FDA’s Acknowledgement Without Objection or AKL letter, and within its statutory 75-day evaluation period to respond. It has been assigned NDI report number 1103. CarnoSyn® is the only beta-alanine that has successfully obtained NDI status with the FDA.
NAI, headquartered in Carlsbad, California, is a leading formulator, manufacturer and marketer of nutritional supplements and provides strategic partnering services to its customers. NAI’s comprehensive partnership approach offers a wide range of innovative nutritional products and services to NAI’s clients including: scientific research, clinical studies, proprietary ingredients, customer-specific nutritional product formulation, product testing and evaluation, marketing management and support, packaging and delivery system design, regulatory review and international product registration assistance. For more information about NAI, please see its website at http://nai-online.com.
This press release contains forward-looking statements within the meaning of applicable securities laws that are not historical facts and information. These statements represent our intentions, expectations and beliefs concerning future events, including, among other things, our expectations and beliefs with respect to the outcome of pending litigation, the continued validity of our patents, and our ability to successfully develop, license and enforce our intellectual property rights. We wish to caution readers these statements involve risks and uncertainties that could cause actual results and outcomes for future periods to differ materially from any forward-looking statement or views expressed herein. NAI’s financial performance and the forward-looking statements contained herein are further qualified by other risks including those set forth from time to time in the documents filed by us with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
CONTACT – Kenneth Wolf, President and Chief Operating Officer, Natural Alternatives International, Inc., at 760-736-7700 or [email protected]
Recently, Business View Magazine spoke with NAE’s Founder and CEO, Mark LeDoux, and engaged in a wide-ranging discussion about his company and the natural products sector, in general. The following is an edited transcript of that conversation.
“Obviously, this doesn’t replace medical intervention when people have significant diseases and/or broken bones, or heart attacks, or things of that nature, which require immediate attention. I was really focusing on those areas where people have consistent problems – whether it’s allergies, difficulty sleeping, or joint discomfort or pain that comes with repetitive motion or too much exercise or too much laborious work, and things of that nature.
“So, that’s how the business got started, and a couple of years after I started it, I was having other people manufacture products for us and our distribution channels were largely through health food retailers, and some clinicians – osteopaths, medical doctors, and others who were looking for natural remedies to give to their patients, along with whatever other interventions they were doing, and the business grew quite dramatically.”
BVM: What is the state of the company, today?
“Our Swiss facilities have multiple licensures, as well, including a pharma license from the Swissmedic entity in Bern, which is sort of equivalent to the FDA (Food and Drug Administration) in the United States. So our focus has largely been on contract manufacturing for large, multi-national companies. We also have a division where we mine our intellectual property with our own product known as CarnoSyn, which is multiple-patented amino acid for a variety of markets – sports nutrition, nutrition for the elderly, and healthcare practitioner markets. That represents about 15-20 percent of our marketplace and contract manufacturing represents between 80 and 85 percent.”
BVM: What are some of the most pressing and current issues in the natural products sector?
“There are some other front burner issues. We’ve been working very closely with the Food and Drug Administration to try and identify those products that are being sold that are illegal, per se, in the United States. The FDA has a tough job to do because it has to enforce all types of regulations across a panorama of foods and drugs. But we’re trying to get them more resources and get them focused on taking some low-hanging fruit out of the marketplace so that responsible companies can enter the fray with products that are made according to the good manufacturing practices that are on the books.
BVM: What’s the long-term outlook for NAI?
“I also think that one of the reasons that people gravitate towards us is because the consumer is coming – not only in North America, but around the world. There’s been somewhat of a breach of trust that has taken place over the last several decades between companies that are saying, “Trust me, this is great,” and then the end result maybe being not so great. And the consumer, with access to the internet, access to information and research, is becoming much more knowledgeable, much more inquisitive, and justifiably skeptical. So, they’re doing their homework before they make purchase decisions. And it’s incumbent for us to continue to make those appropriate investments in answering the questions that consumers have: Is this product beneficial for me and my family? What will it do? How does it work? And how can you make sure that the sources work? And how can you make sure that the sources work? And how can you make sure that the sources from which you bring this product to market remain sustainable for the globe that we live on?
So, with that approach, our focus is to enrich the world with the best of nutrition, and we are driven to exceed our customers’ expectations – not only our customers who are clients, but their consumers, as well. So, those are the precepts that guide us and have given us a very solid path forward.”
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