Tag: Philip Morris International

  • PMI Appoints Former FDA Officials

    PMI Appoints Former FDA Officials

    Photo: PMI

    Philip Morris International has appointed two former U.S. Food and Drug Administration officials to key positions.

    Badrul Chowdhury was appointed PMI’s chief life sciences officer for smoke-free products, succeeding Jorge Insuasty, who will complete his move into the recently created position of president of Vectura Fertin Pharma. After a short transition period, Chowdhury will join PMI’s senior management team in January 2023, reporting to CEO Jacek Olczak.

    “I am delighted to welcome Badrul to PMI and look forward to working closely with him as he leads our talented team of scientific experts,” said Olczak in a statement. “He is an accomplished scientist and regulatory strategist, with decades of leadership experience, both in industry and as a regulator within the U.S. FDA’s pulmonary division. His wealth of knowledge and experience will be critical to help achieve our ambition of a smoke-free future. I also extend my sincere thanks to Jorge Insuasty for his contributions to the function as he moves to oversee Vectura Fertin Pharma full time.”

    Chowdhury joins PMI from a U.S.-based biotech company developing inhalation products for rare respiratory diseases, where he was chief medical officer. Prior to that, he was AstraZeneca’s senior vice president and chief physician-scientist for respiratory inflammation and autoimmunity late-stage development in biopharmaceuticals R&D. From 1997 to 2018, Chowdhury served as director of the division of pulmonary, allergy and rheumatology products at the Center for Drug Evaluation and Research at the FDA.

    Matt Holman

    Matthew Holman was appointed as PMI’s vice president of U.S. scientific engagement and regulatory strategy, reporting to Deepak Mishra, president of PMI Americas.

    “We are delighted that Matt will be joining PMI to further accelerate our journey toward a smoke-free future, particularly here in the United States,” said Mishra. “As we transform, we recognize the importance of bringing together diverse perspectives, including those of regulatory bodies and the scientific community. Matt’s solid scientific and stakeholder knowledge, combined with his passion for tobacco harm reduction, will be invaluable.”

    Holman joins PMI from the FDA, where he served for more than 20 years, most recently as director of the Office of Science at the Center for Tobacco Products (CTP). At the CTP, Holman was instrumental in building the FDA’s marketing application review programs. He served as the CTP’s chief scientist, playing a significant role in guiding policy decisions, developing rulemaking and guidance documents, and overseeing a robust regulatory science research program for tobacco products.

    The appointment of these experts complements the recent hiring of Keagan Lenihan, who joined PMI in May 2022 as vice president of government affairs and public policy and head of its Washington, D.C., office. Lenihan spent two decades working in government, corporate and public policy, including as associate commissioner for external affairs and strategic initiatives and then chief of staff at the U.S. FDA.

  • EU to Decide on Swedish Match Deal by Oct. 11

    EU to Decide on Swedish Match Deal by Oct. 11

    Photo: Berk

    European Antitrust regulators will review Philip Morris International’s $16 million bid for Swedish Match by Oct. 11, reports Reuters, citing a Sept. 6 European Commission filing.

    At the end of its scrutiny, the EU competition enforcer can clear the deal with or without remedies or it can open a four-month-long investigation if it has serious concerns.

    In August, PMI extended the acceptance period for its offer from Sept. 10 to Oct. 21 following indications that the European regulators needed more time to review the proposed takeover.

    The multinational says it has already obtained approvals from other prominent regulators, including those in the United States and Brazil.

  • PMI Mulls Lowering Threshold for SM Bid

    PMI Mulls Lowering Threshold for SM Bid

    Photo: Swedish Match

    Philip Morris International is considering lowering the acceptance threshold on its $16 billion takeover bid for Swedish Match, reports Bloomberg, citing people with knowledge of the matter.

    The multinational is reportedly contemplating the move as it seeks ways to increase the likelihood the acquisition will go through amid opposition from shareholders, including Elliott Investment Management.

    Elliott has secured a 5.25 percent stake in Swedish Match. The activist investor has a history of building stakes in European targets to block full takeovers and secure a higher price.

    PMI’s bid was originally conditional on it getting more than a 90 percent stake in Swedish Match, a level that would normally allow it to squeeze out any remaining dissenters and take the company private. The idea of lowering the acceptance threshold raises the prospect that Philip Morris could end up with a majority stake in Swedish Match and keep it publicly traded, at least temporarily.

    Last month, Philip Morris extended the acceptance period for the offer to Oct. 21 after regulators in Europe indicated they needed more time to review the bid.

  • UTC to Manufacture PM Products for Egypt

    UTC to Manufacture PM Products for Egypt

    Photo: akolosov.art

    Philip Morris is set to start manufacturing its products for the Egyptian market at its United Tobacco Co. (UTC) subsidiary, reports Daily News Egypt.

    The current licensee, Eastern Co., will continue to manufacture Philip Morris’ cigarette products until its production stock has been depleted.

    Philip Morris stated that it is proud of the strategic partnership with the state tobacco company, which lasted for nearly half a century, and is looking forward to sustaining this partnership through Eastern’s shareholding in UTC. In May, Egypt’s General Assembly approved Eastern Co.’s plan to buy a 25 percent share in UTC for EGP100 million ($5.2 million), according to the Enterprise Press.

    Eastern Co. Managing Director Hani Aman said at the time that his firm would be represented by two members on UTC’s board of directors.

    The acquisition was part of the Philip Morris subsidiary’s agreement with Eastern Co. to locally manufacture cigarettes. UTC was the only company to bid in last year’s tender after other companies complained that the conditions of the tender would establish a monopoly over the local market.

    Philip Morris confirmed its full commitment to all existing contractual relationships with traders and suppliers to guarantee the availability of its products across Egypt’s governorates. The company said it will continue to provide all of its products at the same prices as recently officially set with no change to the packaging.

    Aman said that the Eastern Co. is trying to absorb the rise in production costs internally, resulting from the recent rise in the cost of raw materials.

    He pointed out that the disruption of supply chains had a direct impact on the rise of some production inputs, in addition to the impact of the rise in the price of the U.S. dollar on other products.

    Eastern Co.’s tobacco business reported revenues of EGP12.78 billion for the first nine months of fiscal year 2021-2022, up 5 percent over those of the comparable period in the previous year.

  • The Perfect Match?

    The Perfect Match?

    Photo: Swedish Match

    A takeover of Swedish Match would give Philip Morris International a comprehensive portfolio of reduced-risk products.

    By Stefanie Rossel

    Philip Morris International may take a giant step this year toward its goal of becoming a smoke-free company. In May, the multinational offered $16 billion to acquire Swedish Match, a Stockholm-based maker of oral nicotine products known for brands such as Zyn, General, Oliver Twist and Longhorn. If accepted by shareholders, PMI CEO Jacek Olczak said in a webcast on May 11, the deal would greatly accelerate the fulfilment of PMI’s smoke-free ambitions and position it to lead that transformation in the industry. PMI aims to reach more than 50 percent smoke-free net revenues by 2025 as compared to 30 percent in the first quarter of 2022 and essentially zero in 2015, when the company launched its IQOS heated-tobacco product.

    The takeover has the potential to greatly benefit both companies. Swedish Match’s large portfolio of pouch and snus brands is largely complementary to that of PMI, and company cultures and organizations of both businesses are a fit, Olczak emphasized. The Swedish manufacturer shares PMI’s vision of working toward a smoke-free future without cigarettes; more than two-thirds of its revenues and around three-quarters of operating profits are from smoke-free products.

    Around one quarter of sales are generated by Swedish Match’s cigar business, which the company in 2021 planned to separate via a spin-off to shareholders and a subsequent listing on a U.S. securities exchange. However, in mid-March this year, Swedish Match’s board of directors decided to suspend the preparations for the contemplated spinoff until further notice.

    If Swedish Match’s shareholders approve the takeover, it would give PMI a comprehensive global reduced-risk products portfolio with leading positions in heated tobacco and nicotine pouches, the fastest-growing category of oral nicotine, with potential for accelerated international expansion, Olczak explained. Together with PMI’s emerging presence in the vape segment through its Veev product, the combined companies would have a strong position with brands across all three major smoke-free platforms, Olczak pointed out. The merger would add more than 3 million adult users of smoke-free products to PMI’s roughly 18 million IQOS users.

    Strong in the U.S. Smoke-Free Market

    The Swedish company is also well established in geographies where PMI would like to expand its smoke-free products. Of Swedish Match’s sales, more than 64 percent come from the U.S. and 29 percent come from Scandinavia.

    An important aspect of the deal is Swedish Match’s strong position in the lucrative U.S. market. Excluding China, the U.S. nicotine industry is the world’s largest by value, with retail value accounting for around 30 percent of the international market. Around 34 million Americans smoke.

    In smoke-free products, the U.S. alone generates more than half the retail value of all other countries bar China combined. In 2021, the U.S. smoke-free market accounted for about 23 percent of the country’s total nicotine volume, and its retail value continues to grow strongly at a compound annual growth rate (CAGR) of around 13 percent since 2018, according to Olczak. The purchase of Swedish Match would increase PMI’s directly addressable market for smoke-free products in the U.S. by approximately 60 percent.

    Of the U.S. $1 billion nicotine pouches category, Swedish Match holds a 64 percent volume share with its fast-growing Zyn brand. The product’s extraordinary performance catalyzed the category in the U.S. in 2021, leading to an expansion of volumes by approximately 80 percent last year alone, Olczak said. With more than 500 salespeople, access to over 150,000 points of sale and manufacturing and support functions, Swedish Match has a substantial platform in the U.S. In 2019, eight products sold under Swedish Match’s General snus brand received the first modified-risk tobacco product (MRTP) orders from the Food and Drug Administration.

    To date, PMI has made only limited progress in the U.S.’ growing smoke-free market. In the U.S. and elsewhere, the company has zero or negligible presence in the nicotine pouch category, according to Olczak. And while IQOS, too, has received MRTP orders, PMI had to halt the product’s U.S. rollout in November 2021, when the International Trade Commission (ITC) ruled that the heat-not-burn device infringed on two BAT patents.

    PMI had intended to commercialize IQOS under an exclusive licensing agreement with Altria Group’s PMI USA subsidiary. Following the ruling, PMI USA was forced to remove the product from the market.

    In February, during the company’s full-year 2021 earnings call, Altria CEO Billy Gifford said that while he didn’t expect to have access to IQOS devices or Marlboro Heat Sticks in 2022, his company remained focused on returning IQOS to the U.S. market as soon as possible. According to the ITC ruling, PMI can either change IQOS’ design, which would require it go through the cumbersome FDA authorization process again, or manufacture the product domestically. The company has opted for the latter, Olczak revealed in an interview, but he didn’t disclose where in the U.S. production will take place. However, the company said it plans to start selling IQOS again in the first half of 2023.

    Leading in Modern Oral Nicotine

    The global nicotine pouch market is valued at around $2 billion, having grown by approximately 65 percent in 2021. Here, too, Swedish Match leads the category with a volume share of about 40 percent. PMI anticipates the modern oral nicotine category’s retail value to grow by a CAGR of 30 percent to 40 percent over the next five years, with the rest of Europe overtaking fast-growing Scandinavia in the next three years. PMI views low-income and middle-income countries as attractive targets for nicotine pouches, given the products’ simplicity, affordability and ease of use.

    This is where the advantages for Swedish Match from a potential deal would come in: In addition to benefiting from access to the resources of a much larger corporation, IQOS’ extensive international commercial infrastructure and PMI’s complimentary development capabilities would provide Swedish Match with a significant international opportunity for Zyn. PMI is committed to invest in the nicotine pouch category, according to Olczak. Leveraging the strengths of the companies’ respective nicotine offerings could translate into great potential for PMI’s position in Scandinavia.

    Whether the deal will be completed remains to be seen. Swedish Match’s board of directors accepted PMI’s offer and recommended to do the same to its shareholders. Under Swedish law, some 90 percent of shareholders need to agree to the deal for it to proceed. Several investors have objected to the takeover, claiming it was unclear whether the offer price sufficiently reflected the long-term value of Swedish Match. Swedish Match is a fast-growing and profitable company, experiencing a CAGR of more than 17 percent, excluding currency fluctuations between 2018 and 2021, and increasing its cash from operating activities at a CAGR of 20 percent during the same period, from $426 million in 2018 to $738 million in 2021.

    In July, U.S. activist investor Elliott was rumored to be building a stake in Swedish Match to stop the deal, according to Bloomberg. Opposing shareholders can have a significant impact: In 2021, pharma company Astra Zeneca blocked a $7.6 billion takeover of Swedish player Orphan Biovitrum by withholding its 8 percent stake in the company from a buyout offer.

    In the case of Swedish Match, things may turn out differently. Mads Rosendal, an analyst at Danske Bank, wrote in a research note that it was unlikely that Elliot will succeed in building a large enough stake in Swedish Match to thwart the deal on its own.

    Of course, the deal will take effect only after the last signature has been placed. Swedish Match shareholders have until Oct. 21, 2022, to accept the offer.

  • Judge Boosts PM’s Infringement Award

    Judge Boosts PM’s Infringement Award

    Photo: New Africa

    R.J. Reynolds Vapor Co. owes Philip Morris Products more than $14 million after a federal judge on Aug. 17 increased a jury’s June patent-infringement award over vapor products to include prejudgment interest and supplemental damages, reports Bloomberg Law.

    Judge Leonie M. Brinkema amended the judgment entered June 15 in the U.S. District Court for the Eastern District of Virginia to reflect a total judgment amount of $10.9 million for infringement of one patent and $3.16 million for infringement of another.

    In its June 15 judgement, the jury found that RJR’s Vuse Solo and Alto devices infringe two Philip Morris patents covering parts of a vaping device for heating substances and preventing leaks. At the same time, the jury cleared Vuse Alto of infringing one of the patents.

    The verdict concerned counterclaims in RJR’s ongoing patent lawsuit over PMI’s IQOS heated-tobacco device. RJR won an order blocking IQOS imports at the U.S. International Trade Commission last November.

    Philip Morris succeeded earlier this year in invalidating parts of some patents RJR accused it of infringing at a U.S. Patent Office tribunal.

    RJR parent company BAT has also sued Philip Morris over IQOS in the United Kingdom, Germany and elsewhere. A PMI filing with the U.S. Securities and Exchange Commission earlier this year said IQOS patent lawsuits and challenges outside of the U.S. have “repeatedly and universally failed.”

    Altria has separately sued Reynolds for patent infringement in North Carolina over the Vuse line.

  • Hedge Fund Might Force PMI to Raise its Swedish Match Bid  

    Hedge Fund Might Force PMI to Raise its Swedish Match Bid  

    Photo: Swedish Match

    A hedge fund might force Philip Morris International to raise its bid for Swedish Match, according to an article in The Wall Street Journal.

    On May 11, PMI offered SEK161.2 billion ($16.14 billion) to purchase Swedish Match. The acceptance period for the offer was initially set to expire on Sept. 30, 2022, but was later extended to Oct. 21, 2022, as the bid awaits approval from the European Commission.

    The offer is conditional on PMI gaining more than 90 percent of Swedish Match’s Stockholm-listed shares.

    Since the companies announced their deal, Elliott Management Corp. has acquired an undisclosed stake in Swedish Match. According to Massimo Stabilini, a hedge-fund manager at London-based Sinclair Capital, Elliott is trying to get a better price from PMI.

    Elliott would need to buy close to $1.6 billion worth of Swedish Match stock to stop Philip Morris reaching 90 percent, suggesting it might need others to join its campaign. Under Swedish rules, it will also have to disclose its holding if its stake reaches 5 percent.

    Elliott is not the only Swedish Match shareholder seeking better terms. Earlier this year, shareholder Bronte Capital also opposed the takeover, saying the offer price was “unacceptable,” according to Reuters.

    Investors holding out for a better price are betting that PMI will cough up rather than walk away from the deal. The acquisition is key to the cigarette giant’s stated goal of generating more than 50 percent of its net revenue from smoke-free products by 2025, up from 29 percent last year.

    Elliott has proven willing to play a longer game before, according to The Wall Street Journal. In 2016, it took a more than 10 percent stake in Arcam after General Electric Co. agreed to buy the Swedish 3-D printing company. GE later raised its bid and lowered its minimum approval threshold to 75 percent.

  • Patients Concerned Over Tobacco-Owned Lung Treatments

    Patients Concerned Over Tobacco-Owned Lung Treatments

    Photo: bydvvid

    Seventy percent of respondents to an international survey conducted earlier this year said they are either “bothered” or “really bothered” when tobacco companies make money from an inhaler, medication or other devices that treat their lung conditions.

    The findings are available in a newly published communications brief, “Tobacco industry ownership of pharmaceutical companies: an international survey of people with respiratory disease,” in Thorax, the official journal of the British Thoracic Society.

    A total of 1,196 people who reported inhaler use completed the survey in early 2022.

    After Philip Morris International acquired pharmaceutical company Vectura in 2021, patient advocacy groups wanted to understand patients’ attitudes toward tobacco organizations’ stake in the companies that make their respiratory inhaler devices. Vectura develops several widely used medical delivery devices and/or formulations for inhaled therapies used in people with chronic lung diseases, including chronic obstructive pulmonary disease (COPD) and asthma.

    The COPD Foundation partnered with Global Allergy and Airways Patient Platform and Lung Foundation Australia to conduct the survey among people with chronic lung diseases in English, Spanish and German between January and March of 2022.

    In addition to expressing concern about tobacco ownership of lung treatments, a significant share (48 percent) of patients surveyed also said they would strongly consider switching inhalers if they knew that a tobacco company made or sold their brand of an inhaler.

    “This was an unexpected finding, as many patients in my own practice indicated a preference to stick to medications that work for them,” said Byron Thomashow, chief medical officer at the COPD Foundation, and co-author of the Thorax brief in a statement. “However, socioeconomic, and systemic factors such as insurance coverage, health care system limitations, and convenience strongly influence the patient’s ability to make treatment choices.”

  • PMI Extends Period for Swedish Match Offer

    PMI Extends Period for Swedish Match Offer

    Photo: SergeVo

    Philip Morris Holland Holdings has extended the acceptance period for its offer to Swedish Match shareholders until Oct. 21, 2022, as the bid awaits approval in Europe.

    On May 11, Philip Morris International, through its Dutch subsidiary, offered SEK161.2 billion ($16.14 billion) to purchase Swedish Match. The acceptance period for the offer commenced on June 29, 2022, and was initially set to expire on Sept. 30, 2022.

    In a statement, PMI said it has obtained all international approvals required for the transaction other than merger control approval from the European Commission, which is still pending.

    Based on customary pre-notification discussions with the European Commission, the company believes the European Commission will not complete its review of the transaction before the Sept. 30 expiry date of the initial acceptance period.

    Other than the extension of the acceptance period, the terms and conditions of the offer remain unchanged.

    The Swedish Match board of directors has recommended shareholders accept PMI’s offer, but some shareholders have raised objections.

    Earlier this year, Swedish Match shareholder Bronte Capital opposed the takeover, saying the offer price was “unacceptable,” according to Reuters.

    Another shareholder has also said it was not clear whether the long-term value of Swedish Match was reflected in PMI’s offer price.

    Meanwhile, Elliot Investment Management has reportedly been building a stake in Swedish Match and plans to oppose the pending takeover of the Scandinavian tobacco company by PMI under its current terms.

    However, according to Danske Bank analyst Mads Rosendal, it is unlikely that Elliott will succeed in building a large enough stake in Swedish Match to stop the deal on its own

                                   

  • PMI Halts Cash-for-Vapes Program

    PMI Halts Cash-for-Vapes Program

    Photo: PMI

    Philip Morris International has paused a program that would have paid Australian pharmacists AUD275 ($190.24) when ordering Veev vapes, according to The Guardian.

    The scheme, first reported by News Corp., would have seen pharmacists receive AUD5 every time they dispense a new VEEV script, AUD10 for educating a new patient about the device, and AUD5 for referring patients to a doctor to obtain a prescription. Pharmacists would also receive a AUD275 payment for placing an initial stock order.

    Nicotine-containing vapor products are available only with a doctor’s prescription in Australia.

    The cash-for-vapes program caused an uproar among public health advocates.

    Emily Banks, a professor at Australian National University National Centre for Epidemiology and Population Health, said the tobacco industry wanted to piggyback off the trust Australians place in the healthcare system.

    “Big tobacco wants a piece of that—they want some of the trust to rub off. It’s beyond appalling.”

    “Big tobacco’s attempt at financial kickbacks shows absolute contempt for pharmacists,” said a spokesman for the Pharmaceutical Society of Australia. “Multinational tobacco companies have no place in health care.”

    In a statement, PMI defended the program, saying since 2021 nicotine vaping products had been available in Australian pharmacies as a prescription-only medicine for smoking cessation.

    “Several manufacturers, including PMI, have been providing nicotine vaping products to Australian pharmacies via the stringent regulatory regime. Industry data indicates that across multiple manufacturers products are now available in over 2,000 pharmacies nationwide,” the statement said.