Tag: 22nd Century Group

Kinsman Named CFO at 22nd Century

Photo: akub Jirsák | Dreamstime.com

22nd Century Group has appointed R. Hugh Kinsman as chief financial officer. Kinsman is currently CFO of GVB Biopharma, which 22nd Century acquired in May.
“The integration of GVB Biopharma is proceeding very well, and we are excited to build on Hugh’s success at GVB by elevating his financial leadership role to 22nd Century as a whole,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
Kinsman has extensive experience as a senior executive in roles ranging from acting CFO of a publicly traded battery manufacturer with operations in the U.S., Switzerland and Italy, to the CFO of West World Media, a private data aggregation company that was acquired for $60 million.
He also worked at GE Capital where he oversaw over a billion dollars in infrastructure, energy, and communications investments. He began his career at Asher & Company, CPAs (now BDO) and has held a certified public accountant designation.
He earned his Bachelor of Science degree in finance from Penn State University and an MBA from Cornell University.

June 16, 2022
In the CatBird Seat

Photo: 22nd Century Group

A pioneer in nicotine reduction technology, 22nd Century Group is well-positioned as the FDA mulls a mandate for minimally addictive cigarettes.
By Taco Tuinstra
22nd Century Group appears to be a company whose time has come. With a fresh modified-risk tobacco product (MRTP) marketing order for its VLN (very-low-nicotine) cigarettes—the only such authorization granted to a combustible tobacco product to date—and a profound understanding of nicotine reduction technologies, the company is well positioned to benefit from the U.S. Food and Drug Administration’s plan to require tobacco companies to reduce the nicotine in their cigarettes to minimally addictive levels.
22nd Century Group’s hemp/cannabis business, too, has been on a roll, boosted by spreading legalization of the product and new acquisitions. Tobacco Reporter spoke with John Pritchard, 22nd Century Group’s vice president of regulatory science, about the MRTP process, the company’s plans for VLN cigarettes and the company’s views on tobacco harm reduction.

Congratulations on the MRTP marketing orders for your VLN cigarettes. What steps have you taken to commercialize the product since December? Please comment on your plans for the United States and South Korea. Why did you choose South Korea as your first foreign market? And what have you learned from your pilots in the U.S. and South Korea thus far?
Since April 2022, we have launched our VLN cigarettes in 159 Circle K stores as part of a pilot program. Here, we can test our marketing mix to understand what the most effective way to reach adult smokers with our authorized product claims. Based upon the results of the pilot market here in the United States, we will be working closely with Circle K, our launch partner in the convenience channel, to further develop how to take the brand nationally and best appropriately service the 68 percent of adult smokers who want to smoke less.
I am happy to report that some early learnings include: 1) A measurable percentage of VLN purchases are in the carton format, even within a high tax state. We believe this is because adult smokers who are committed to smoking less are believing in the brand proposition, understand the claims the FDA authorized VLN with and how the product can help them. 2) For many years, mainstream news publications have typically not or desired not to cover tobacco and nicotine products in their publications. However, given the unique proposition of VLN, it has received widespread coverage in the Chicago Tribune, Crain’s Chicago Business, Fox 32 Chicago, WBEZ and many other local publications. We were even acknowledged by the Chicago Medical Society’s president as a product that due to the FDA’s authorization and review of our materials is something doctors should be taking seriously with their patients.
Our introduction to the South Korean market was centered around a variety of commercial and demographic criteria where one in three adult men are smokers. This market is in its early phases, and I look forward to providing detail as we move ahead.
What other markets are you considering internationally? For example, are you eyeing New Zealand, which plans to mandate lower nicotine levels in cigarettes?
We have currently launched VLN in South Korea. We absolutely commend the progress of the New Zealand government and their plans to reduce the harm caused by smoking as well as the wider initiatives they are pursuing. While no cigarette is a safe cigarette, VLN contains 95 percent less nicotine, the addictive component of cigarettes, and our proprietary tobacco genetics ultimately make possible New Zealand’s forward-thinking approach to harm reduction as well as compliance with such product standards there or elsewhere.
That said, we are taking an iterative approach to our commercial expansion and [remain] focused on the importance of the U.S. pilot. Beyond that, we have identified numerous international markets that we are continuing to evaluate; at this point, we will not comment in detail about them just yet. We will, however, be attending the Intertabac Tradeshow in Dortmund, Germany, this fall and are looking forward to meeting with specialty tobacco distributors in attendance who would like to diversify their portfolio of products with a product authorized by the United States FDA to help adult smokers smoke less.

You had been anticipating MRTP designation for some time. What actions did you take in the run-up to authorization to prepare for increased production and sales? Please comment on the expansion of your low-nicotine, tobacco growing operations, the installation of new testing equipment, partnerships with retailers and your move to a new headquarters.
We were always highly confident that we would secure an FDA authorization, given the comprehensive scientific evidence base that has been established, both from our own research and the decades-long interest and clinical studies by health agencies and public health researchers. Moreover, we have established a strong regulatory and compliance function that has been fully supported by our executive team and board.
Drawing closer to the final marketing granted orders, we built out our commercial team, bringing on board highly experienced individuals with a unique blend of knowledge of the tobacco sector and emphatic support for how the product could help adult smokers. These hires include industry experts and disrupters for our commercialization team, including John J. Miller, previously with Swisher International and UST; John Ellegate, previously of Kretek International and R.J. Reynolds; and Sam Morales, previously [of] Cannadips, Swisher International and Drew Estate.
On the operations side, we’ve planted a record crop acreage this year to be able to support our national launch plans. We have also made substantial investments elsewhere in our manufacturing base. Our factory, for example, utilizes state-of-the-art manufacturing equipment, robust manufacturing processes and quality measures to be able to produce VLN reduced-nicotine tobacco cigarettes at the same speed and scale as conventional high-nicotine cigarettes.
Please describe your experience going through the MRTP process. What was good about it, and what parts need improvement? What would you advise other players considering an MRTP application?
Well, it wasn’t particularly easy—a classic British understatement—as those whom I worked with on the MRTP project know only too well. The modified-risk tobacco product application process is certainly the most rigorous and scientific process I’ve ever been a part of in my tobacco career. While it is a long and multistep process, we acknowledge that FDA had a vast amount of scientific literature to review—much of which was done whilst FDA managed the needs and disruption caused by Covid. This attention to detail and thorough review is essential because it allows the industry, the trade and—with product introduction—the adult consumer to have confidence and trust in the statements authorized by the FDA and how we describe our product.
Since launching, we’ve seen numerous points of view published by the trade in regard to our product and its proposition to adult smokers—the rigor of the MRTP application process is incredibly important because it allows the FDA to have the loudest voice in the room, so to speak, and helps trade partners and adult smokers receive and understand messages which are truly based in science. I particularly enjoyed working with a range of subject matter experts and seeing their shared enthusiasm for what we were working to achieve. The profound public health impact of cigarette addiction in the U.S. and elsewhere was and remains a significant motivation for me and for the team.
As for advice to other companies, I remain fully committed to reducing the harm caused by smoking, and [I] encourage all companies with appropriate products to utilize the MRTP application pathway. We are not a large company when compared to most U.S. tobacco interests and yet were able to navigate the complexities and challenges to bring something new and needed to adult smokers. Adults need access to and choice of alternative products that are supported by a robust evidence base, and we believe that having more MRTP-authorized products in the market will enable the industry to more rapidly move adult smokers to smoking less or to switch to using less harmful products [and] thus ultimately help end cigarette addiction.

What, if anything, did you learn from the experiences of PMI and Swedish Match in the wake of their IQOS and General Snus MRTP authorizations? Will you market your product differently?
In considering other MRTP applications, it was apparent that while there are statutory requirements that are cross-cutting for all applications, each individual product that has been authorized or that is currently under review by FDA raised different public health and scientific questions. To that end, it was important to recognize what FDA’s concerns were or could be and ensure that we responded earnest[ly] and fully to these with appropriate evidence.
At the same time, we are grateful to the many researchers and experts within health agencies and academia for their meticulous work that contributed to the evidence base for our product, with many of such studies addressing key public health questions relating to reduced-nicotine content products.
As I am sure you have seen recently, PMI has made an offer to acquire Swedish Match, including both the innovative modern oral ZYN brand and the heritage General Snus brand—this leaves 22nd Century Group as the only other company in the world with an MRTP authorization from the FDA. The opportunity between General Snus versus VLN is entirely different. General Snus provides an offramp for interested adult smokers to continue with their nicotine consumption but changes their form factor or modality greatly, thereby reducing their exposure to combustion.
VLN provides a complete offramp from nicotine since each cigarette does not contain enough nicotine to create or sustain addiction, allowing the adult smoker to make the switch to VLN and to reduce their daily cigarette consumption. So in this regard, we do not see other MRTP products as direct competition so much as representing wider industry progress toward a future where cigarette addiction is no longer a public health disaster.
Where do you see VLN in the constellation of reduced-risk products? How will VLN cigarettes help reduce the public health toll of smoking?
It’s important to first understand that the industry has failed many adult smokers through its innovation to date. “But what about …?” I hear you say. Well, “one swallow does not a summer make,” and with over a billion smokers globally, there is clearly much to be done before the industry congratulates itself just yet.
Moreover, much innovation is sold to wealthy countries and excludes poorer countries where some companies seem entirely content to aggressively market highly addictive cigarettes. While product innovations containing nicotine—including vapor, pouches, gum, lozenges—and other modern oral products have gone some way to reducing smoking, general mistrust of the industry, contradictory corporate activity as well as willful misrepresentation of the science by some well-known anti-tobacco groups all work against the consumer and by extension the public health interest.
I am fully in favor of whatever means an adult smoker utilizes to help them reduce or cease their consumption of highly addictive combustible products. We should acknowledge that all responsible industry members share a similar end goal, but the path we take with our adult customers is demonstrably different; there is no “one size fits all.” I believe it is important that all product solutions that are backed by science and appropriately regulated must be made available to adult smokers to reduce the harm caused by cigarette addiction.

Some tobacco harm reduction advocates contend that VLN’s MRTP diverts smokers from better choices, stating that “people smoke for the nicotine but die from the tar.” What is your response to such criticism?
It’s always painful to see the industry as a whole posture and seek to create black and white narratives around an issue that is everything but binary. Nicotine gum was developed back in the 1970s and has doubtless helped many smokers even with the low efficacy of the product—and yet there are still more than $700 billion a year worth of cigarettes sold globally. The same can be said of vape technology, which has existed in multiple formats for over a decade. While millions have switched to vape, tens of millions of Americans still smoke highly addictive cigarettes.
So for us, VLN addresses a unique adult smoker need, which is not asking the adult smoker to switch to a new form factor or modality in their journey but simply asking them to make a switch to [a] product that contains significantly less of the addictive substance in cigarettes. With over 50 clinical studies, and now the authorization by the FDA that VLN helps adult smokers smoke less, it is quite clear to me that the criticism is not based on the science of our product.
Criticism of our product approach or other options by some industry voices or their familiars may play well with the gallery at conferences or other echo chambers but does not serve the interests of the individual smoker and so is ultimately self-defeating, despite their self-styled tobacco harm reduction approach. You know who you are.
I would encourage all adult smokers to use whichever product or products they feel will best help them end their use of highly addictive cigarettes and, as always, people concerned about their cigarette addiction should speak with their healthcare providers – as they can provide access to a range of other Rx product options. Our goal is simple: to make VLN available as a choice to adult smokers alongside other appropriately regulated alternative products that make up the MRTP set; people want and deserve options not dogmatic opinions.
22nd Century has repeatedly said it is willing to license its reduced-nicotine tobacco technology to other cigarette manufacturers. Has the industry expressed interest?
You’ll appreciate that at this time, I will not be sharing specific details. What I can say is that since the FDA has announced its intention to ban menthol cigarettes along with flavors in other tobacco products, we have had an incredible amount of outreach from the industry and trade. It’s really exciting to see new participants, such as convenience chains, drug stores and grocery stores, from across the United States paying attention to the FDA, the FDA’s goals and ultimately products like ours that align with the FDA’s goals as well as their corporate ethos. We are committed, as ever, that when the United States and other countries bring in limits for nicotine content in cigarettes, we will license our tobacco genetics to the industry to enable their compliance with such requirements.

After announcing its intention to reduce nicotine levels to minimally addictive levels in 2017 and again referring to the concept when it first announced plans to ban menthol in the spring of 2021, the FDA appears to have gone quiet on the plan again. Do you expect the FDA to enact a nicotine standard in the near future, and how important is such a standard to the success of VLN cigarettes?
While I cannot speak directly or indirectly for the FDA, I believe the FDA is taking the appropriate steps by focusing its efforts on the ban of high-nicotine menthol cigarettes. While some parts of industry will doubtless challenge this, they should recall that their own actions have led to the need for such regulation to be considered in the first place.
I believe the elimination from menthol in highly addictive cigarettes is an important step to reducing the attractiveness of highly addictive tobacco or nicotine to youth, a view which should be shared by industry participants as a key concern as it is for the FDA.
I am confident that we will see a nicotine standard in the coming years as appropriately regulated alternative products become increasingly available as well as a shift in public health messaging relating to such products. At this juncture, we see that our genetics and intellectual property are uniquely able to support such forward-thinking and pioneering harm reduction effort, which will save millions of lives, and we are excited to play our part in this vast public health opportunity.
In a press note dated April 29, 22nd Century Group said it expected its VLN Menthol King reduced-nicotine cigarette to be exempted from the FDA’s proposed ban on menthol cigarettes. Please explain why you expect this to happen.
We expect that the FDA will allow for a reduced-nicotine menthol cigarette to stay on the market in order to provide an offramp for adult smokers who currently use menthol cigarettes. In authorizing our MRTP applications, FDA was clear that such products have a role to play in both menthol and nonmenthol product styles to reduce their consumption of nicotine-containing products. With so many individuals smoking menthol cigarettes, we think it is prudent for the FDA to allow those smokers more options and not less to help reduce their exposure to nicotine and products containing nicotine.
Where do you see 22nd Century Group five years from now? What are the challenges that need to be overcome to achieve that vision?
Most people know the company for its leadership in reduced-nicotine tobacco technology; however, this is only one part of our business. Recently, we acquired GVB Biopharma, a contract development and manufacturing organization. GVB is one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage. GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas and cultivation capabilities at Needle Rock Farms. The combination with 22nd Century establishes a global one-of-a-kind company to serve the rapidly growing hemp/cannabis ingredient market.

Taco Tuinstra is Tobacco Reporter’s editorial director. Based in Raleigh, North Carolina, USA, he coordinates the work of staff writers and contributors. On his watch, Tobacco Reporter has won several awards for editorial excellence. Since joining the magazine in 1997, Taco has visited more than 75 countries to meet industry representatives in their markets and to report tobacco news firsthand.

June 1, 2022
John Miller Joins 22nd Century Group

John Milller

John J. Miller has joined 22nd Century Group to help the company achieve the full potential of its reduced-nicotine business.
Miller has more than 35 years of experience in the tobacco and consumer packaged goods industries. He will work directly with Jim Mish, CEO, and with Michael Zercher, chief operating officer of 22nd Century Group.
“We are absolutely delighted to welcome John Miller to our team,” said Mish. “His significant hands-on expertise and insight in strategic planning, assessing and implementing strategic partnership opportunities, and leading sales and marketing efforts will be instrumental in accelerating revenue, profit and market share growth for the company. We look forward to John’s contributions to the success of the company’s launch of VLN, our reduced nicotine cigarettes with 95 percent less nicotine than conventional cigarettes, which is the first and only modified-risk tobacco product approved by the FDA.”
“I am extremely impressed with the team of outstanding professionals at 22nd Century Group and their commitment to product innovation,” said Miller in a statement. “I am very enthusiastic to be joining the company at this pivotal time in its history and leading the VLN initiative on the heels of the product’s successful pilot launch. VLN is a transformative brand with tremendous market potential. I am incredibly optimistic about the meaningful difference it could make in the lives of people to help them smoke less.”
Most recently, Miller was the president and CEO of Swisher International, a 160-year-old leading lifestyle brands company that is the largest manufacturer and exporter of cigars and smokeless tobacco products in America. Miller joined Swisher in November 2012 as senior vice president of sales and marketing, was promoted to president in 2017 and was named CEO in March 2021.
Miller’s experience also includes more than 20 years in various management positions at U.S. Smokeless Tobacco Co. As regional vice president, he had direct oversight and responsibility for all sales, planning and operations for key brands in the Western United States. U.S. Smokeless Tobacco Co. was acquired by Altria in 2009.
Miller holds a Bachelor of Science degree in finance from the University of Nevada, Las Vegas and a Master of Business Administration degree from the George L. Graziadio School of Business Management at Pepperdine University.

May 24, 2022
22nd Century Begins Integration of GVB

Photo: chokniti | Adobe Stock

22nd Century Group has begun integration of GVB Biopharma, which it acquired on May 13, 2022, according to a company press release. As a contract development and manufacturing organization (CDMO), GVB is a market share leader in hemp-derived active ingredients for the nutraceuticals, pharmaceutical and consumer goods industries. 22nd Century has posted a presentation, which includes an overview of GVB’s business operations, the strategic benefits of the acquisition, and strengths of the combined companies, on the “Investors” section of its website.
“We are excited to welcome the GVB team into the 22nd Century family,” said James A. Mish, 22nd Century’s CEO. “Together, we believe 22nd Century now provides the most complete hemp/cannabis solution in the world, from receptor science and transformative plant genetics to finished ingredients and CDMO formulated products that meet the most exacting standards required by global consumer products and pharmaceutical companies. We can now offer complete, vertically integrated cannabinoid manufacturing technologies, creating industry-leading scale and cost efficiency alongside our proprietary hemp/cannabis plants designed to bring the commercially desirable traits and stable genetics critical to realizing the full potential of this exciting market.”

May 19, 2022
22nd Century Acquires GVB Biopharma

Photo: cendeced

22nd Century Group has acquired GVB Biopharma. As a contract development and manufacturing organization, GVB is believed to be one of the largest providers of hemp-derived active ingredients for the pharmaceutical and consumer goods industries worldwide based on total tonnage.
GVB’s strengths complement 22nd Century’s existing upstream and downstream value chains, which includes expertise in cannabinoid receptor science with CannaMetrix, plant research and proprietary genetics through its KeyGene partnership, breeding expertise with Extractas, and cultivation capabilities at Needle Rock Farms.
GVB expects 2022 revenue of approximately $48 million, a 58 percent increase year-over-year, gross margin in excess of 44 percent and positive cash flow. Upon closing, the transaction is expected to more than double 22nd Century’s revenue, be immediately accretive to adjusted EBITDA, and generate positive cash flow from the acquired assets in the near term.
“GVB represents a transformational acquisition for 22nd Century that will enable us to rapidly grow our hemp/cannabis franchise,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“GVB is one of the largest CBD suppliers globally, possessing innovative, vertically integrated cannabinoid product manufacturing technologies driving industry leading scale and cost efficiency. In addition to immediately expanding our hemp/cannabis franchise capabilities, GVB represents an opportunity to double our revenue and internalize a comprehensive contract manufacturing and extraction platform which can be used to directly and exclusively monetize our differentiated and proprietary hemp/cannabis plant genetics and intellectual property. We are enthusiastic to begin working with the highly regarded and very experienced management team at GVB.”
“We are excited to combine with 22nd Century group, pairing our production and manufacturing capabilities together with the best hemp/cannabis plant science in the world,” said Phillip Swindells, chief executive officer at GVB. “Since 2017, we have built a loyal customer base and continue to add new, rapidly growing customers as demand in our industry accelerates. We sold more than five billion doses of CBD in 2021, and we look forward to further scaling our business as a part of 22nd Century’s comprehensive platform.”
GVB operates three U.S. manufacturing facilities in Oregon and Nevada, including a 30,000-square-feet hemp ingredient manufacturing facility in Central Oregon, a 40,000 square-feet white-label, finished product manufacturing facility in Las Vegas, and an industrial-scale hemp extraction facility in Prineville, Oregon.

May 16, 2022
22nd Century Reports Quarterly Results

Photo: 22nd Century Group

22^nd Century Group reported net sales of $9 million for the first quarter of 2022, up 33 percent from the comparable 2021 quarter. The increase was due to increased contract manufacturing volumes in both filtered cigars and cigarettes, including products for export markets and pricing adjustments.
Gross profit for the first quarter was $500,000, compared to $600,000 million in the prior year first quarter. Gross margin in the first quarter was reduced by lower research cigarette sales volume compared with the prior year, and a Master Settlement Agreement adjustment of $200,000 recorded in the quarter.
Operating loss for the first quarter 2022 was $8.1 million, compared to an operating loss of $5.2 million in the prior year period. Net loss was $8.9 million.
“We are off to an exciting start with our VLN reduced nicotine content cigarette pilot launch at more than 150 Chicagoland Circle K stores,” said James A. Mish, chief executive officer of 22nd Century Group, in a statement.
“The recently proposed menthol cigarette ban by the FDA could leave our VLN Menthol King reduced nicotine cigarettes as the only menthol cigarette on the market, helping adult menthol smokers find an off-ramp from nicotine addiction. Early sales in our Chicago pilot affirm the importance of this approach, with sales of VLN Menthol King already selling ahead of non-menthol in pilot stores. We fully anticipate an even more favorable regulatory environment as the FDA continues to advance the agency’s comprehensive plan, which includes requiring all cigarettes to be ‘minimally or non-addictive,’ a standard our VLN King and VLN® Menthol King cigarettes already meet.”

May 5, 2022
22nd Pilots its Low-Nicotine Brand in Illinois

Photo: 22nd Century Group

22nd Century Group’s VLN cigarettes are now available through a national pilot in select Chicagoland Circle K stores, the company announced in a press release.
Containing 95 percent less nicotine than conventional cigarettes, VLN cigarettes in December 2021 became the first combustible cigarettes to receive authorization from the U.S. Food and Drug Administration to be marketed as modified-risk tobacco products.
When choosing Chicagoland for the pilot, 22nd Century noted smokers are found within every segment of the population, many of whom are looking for alternatives. The Centers for Disease Control estimates 15.5 percent of Illinois adults aged 18 years or older smoke cigarettes, higher than the national average of 12.5 percent, according to 2018 state and 2020 national statistics.
A pack of VLN cigarettes will be similarly priced to full nicotine premium brands, approximately between $9 and $12, depending on tax. Illinois is the second most expensive cigarette retail market in the United States.
The three- to six-month pilot will be the first U.S. sales of VLN King and VLN Menthol King cigarettes. 22nd Century is also launching VLN cigarettes in South Korea, its first international market. Following the pilot, 22nd Century and Circle K intend to expand sales nationwide to more than 7,000 stores in 48 states.
On April 4, 2022, the Illinois Attorney General’s Tobacco Enforcement Bureau added 22nd Century Group’s VLN cigarettes to the Illinois Directory of Participating Manufacturers listing. The registration was the final step before 22nd Century could begin distribution.
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April 18, 2022
Treat Joins 22nd Century as CSO

22nd Century Group has appointed Calvin Treat as chief scientific officer, effective May 23, 2022. In this new role, Treat will lead the expanding scientific, research and technological operations of the company, leveraging its expertise, IP and partnerships across all three of its alkaloid plant franchises toward becoming a global leader in specialty plant science.
“Dr. Treat brings a wealth of plant-based biotechnology and crop technology experience to 22nd Century at a pivotal time when we are rapidly expanding our global capabilities across all three of our alkaloid plant franchises—tobacco, hemp/cannabis and hops,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“Dr. Treat has spent his career at the largest plant science names in the world, leading their innovations on major crops like corn, soybeans and cotton. We look forward to his leadership as we continue to leverage our extensive technology platform comprising hundreds of patents, extensive know-how and global partnerships supporting our leadership in plant genetics, breeding and cultivation underpinning our growth opportunities across a growing $1.3 trillion worldwide market opportunity.”
“22nd Century is rapidly establishing itself as the global alkaloid plant technology leader, bringing to bear an extensive upstream capability to optimize plant lines and enhance critical commercial traits that directly benefit quality, cost and consumer confidence in the end products. The company is leveraging the most advanced plant science techniques and building a global IP and capability set that may be unrivaled in their respective crops,” said Treat.
“I am excited to join 22nd Century at this pivotal moment to lead the company onto the global stage as more and more of the world’s leading alkaloid plant growers come to recognize the incredible value of 22nd Century’s portfolio.”
Treat previously served as senior vice president and head of crop technology for corn, soybean and cotton at Bayer, where he oversaw more than $2 billion in R&D spending dedicated to seeds, traits and crop protection while also driving tailored solutions to meet grower needs.
Previously, he was the technology lead for Monsanto’s global corn and soy crops, where he merged the soy and corn technology teams to garner synergies across the platforms. While part of the Monsanto teams, he was involved in the launches of multiple technologies, including Roundup Ready 2 Yield soybeans, Intacta RR2 Pro soybeans in South America and Roundup Ready 2 Xtend soybean technology across North America, one of Monsanto’s largest and most complex trait launches. His additional roles at Monsanto included global corn technology lead, global oilseeds technology lead and global soybean breeding lead, among others.

Photo: Jacub Jirsak

April 11, 2022
22nd Century Reports Results

Photo: MIND AND I

22nd Century Group reported net sales of $30.9 million for 2021, up 10.1 percent from 2020. The increase was due to an increase in contract manufacturing sales. Gross profit for 2021 was $2.1 million compared to $1.4 million in the prior year. Gross margin in 2021 increased to 6.7 percent from 5.1 percent in the prior year.
Net sales for the fourth quarter of 2021 were $8 million, an increase of 8.9 percent over the prior year period. The increase was due to an increase in contract manufacturing sales. Gross profit for the fourth quarter of 2021 was $387,000 compared to $588,000 in the prior year period due to the favorable effect of a large customer order that benefitted the previous year’s fourth quarter.
“The past several months were incredible as 22nd Century transforms from a pure science and contract manufacturing company into a company selling branded VLN cigarettes, licensing valuable biotechnology IP and supplying highly specialized plant lines in large and dynamic global end markets,” said James A. Mish, CEO of 22nd Century Group, in a statement.
“We secured our highly anticipated FDA MRTP [modified-risk tobacco product] designation on Dec. 23, and immediately moved to launch our VLN pilot program by the end of March. The first VLN cigarettes packaged with the FDA’s added claim of ‘Helps You Smoke Less’ rolled off our manufacturing lines in late January.
“Additionally, we have finalized our point-of-sale materials to educate adult smokers about how to use VLN to change their relationship with highly addictive nicotine cigarettes, and we have worked alongside Circle K to prepare for our first launch in more than 150 metro Chicago stores before rolling VLN out nationwide. Our mission is to get this product as quickly as possible into the hands of adult smokers, 70 percent of whom want to quit and are looking for new and innovative products to help them smoke less.”
On Feb. 28, 22nd Century announced its VLN cigarettes would make their international debut in South Korea.

March 1, 2022
22nd Century to Launch VLN in South Korea

Photo: 22nd Century Group

South Korea will be the first international market to commence sales of 22nd Century’s VLN reduced nicotine content cigarettes, the company announced in a press release.
“South Korea is an ideal international launch market in many ways, with a high smoking rate among developed countries and a government strongly committed to smoking harm reduction. We expect the first sale of VLN reduced nicotine content cigarettes to our South Korean partner to occur by the end of March,” said 22nd Centur4y’s CEO, James A. Mish.
“Approximately one in three adult men in South Korea are smokers, and an estimated 6 percent of adult women smoke. The government has worked over the past two decades to promote smoking cessation through a variety of means, including heightened tobacco prices, and remains committed to advancing alternative products to help curb smoking activity in the country. We are excited to make VLN reduced nicotine content products available in South Korea to help break the nicotine addiction cycle and support this important effort.”
The company will continue its launch process in additional markets in Asia and Europe with limited regulatory barriers while also leveraging VLN’s modified-risk tobacco product (MRTP) authorization in the United States toward seeking approval in additional markets with higher regulatory barriers.
In addition to its first international launch of VLN reduced nicotine content cigarettes in the more than $800 billion global tobacco market, 22nd Century Group is actively moving forward to launch VLN in the $80 billion U.S. market.
The U.S. FDA authorized 22nd Century’s VLN reduced nicotine content cigarette products on Dec. 23, 2021. The company is currently executing its 90-day post-authorization plan to launch in its first U.S. pilot market.

February 28, 2022