Latest news with #Mylan
RNZ News
6 days ago
- Health
- RNZ News
Pharmac to fund two oestrogen patches
Patients will be able to use either brand, "subject to availability". Photo: 123RF People who need oestrogen patches will have access to two brands free of charge from 1 December. Pharmac announced they had decided following consultation earlier this year to fund the oestradiol patches Estradot and Estradiol TDP Mylan. Patients will be able to use either brand, "subject to availability". Manager for pharmaceutical funding Adrienne Martin said the agency understood the importance for "people to have access to the treatment that works best for them". "We've heard very clearly from many people that while different brands of patches should work the same, this is not everyone's experience. "That's why we're funding two brands - so that people can access the oestradiol patches they need, depending on availability." From 1 December, the other currently funded brands of oestradiol patches will no longer be funded. The final decision followed a public backlash to Pharmac's decision in November to fund only the Mylan-brand, due to ongoing shortages of Estradot. More than 1300 people signed a petition calling on the government to keep the Estradot brand available on the basis the Mylan-brand was less effective in controlling menopausal symptoms. Martin said more than 1100 people responded to Pharmac's request for public feedback earlier this year. "We heard from people who wanted us to remove the patch limit and change the dispensing rules," said Martin. "We acknowledge how frustrating these limits are for people but changing or removing them would put pressure on demand, which would increase the risk of these patches not being available. "We will review the patch limit and dispensing rules in 12 months depending on the supply outlook." Pharmac would continue to monitor supply and work to ensure people can access the treatments they need, she said.
Yahoo
07-06-2025
- Business
- Yahoo
Patents and economies of scale support Pfizer's wide moat
Pfizer's innovative business should grow faster after it divests its off-patent division Upjohn in 2020 to create Viatris and Mylan. With fewer older medications and fewer patent losses, Pfizer is well-positioned for consistent growth, excluding the erratic sales of Covid-19-related products. The company is less vulnerable to any one patent loss thanks to its wide range of medications. Because of its more complex manufacturing process and more affordable prices, Pfizer's stronger position in the vaccine marketwhich includes the pneumococcal vaccine Prevnarmakes it more resilient to generic competition. Warning! GuruFocus has detected 6 Warning Signs with PFE. With a 30% to 80% reduction, Trump's executive order would establish a "most favored nation" policy in which the US would pay the same amount for prescription medications as the nation with the lowest price. It is anticipated that this policy, which was previously blocked by courts, will reduce the US's annual drug spending of over $400 billion, saving taxpayers over a seven-year period. Given that drug prices in the United States are high when compared to other countries, Pfizer's U.S. revenue could be drastically impacted by the 30% to 80% price cut, especially for high-margin medications. International reference pricing policies have long been opposed by the pharmaceutical industry, which claims they could hinder innovation and limit access to new companies anticipate that the order will target Medicare and may have an impact on medications not covered by Biden's Inflation Reduction Act. President Trump has said that significant tariffs on pharmaceutical products will probably be announced soon. He has also put a 90-day hold on broader tariffs for the majority of his trading partners to give them time to negotiate. Despite being mostly exempt from tariffs, the biopharma industry is preparing for a possible pharma-specific announcement that might affect global manufacturing strategies. Products made in Europe and imported into the US may be subject to the rumored 25% tariff, necessitating the construction of new facilities that will take years to complete. Due to home country manufacturing, tax benefits, lower production costs, and exposure to currency fluctuations, businesses based in the US and Europe are heavily exposed to European manufacturing. Because drug spending is not cyclical, the direct effect of tariffs on earnings is probably going to be minimal, and the indirect effect of a possible recession should also be minimal. With the exception of small-scale US capacity expansions, biopharma is unlikely to completely reevaluate its manufacturing footprint if pharmaceutical tariffs are implemented but are lifted after 2026 as a result of political pressure from the midterm elections. Leadership in Vaccines Pfizer stands out with its dominant position in vaccines, most notably its highly successful COVID-19 vaccine developed in partnership with BioNTech. This vaccine not only generated significant revenue but also established Pfizer as a leader in mRNA technology, a platform with potential applications in oncology, rare diseases, and beyond. Johnson & Johnson (J&J): J&J also developed a COVID-19 vaccine, but it was less widely adopted due to lower efficacy rates and safety concerns, giving Pfizer a clear advantage in this high-impact area. GlaxoSmithKline (GSK): GSK has a strong vaccine portfolio (e.g., shingles and meningitis vaccines) but did not independently develop a COVID-19 vaccine, relying on partnerships like Sanofi, which delayed its entry and diminished its competitive stance. Bristol Myers Squibb (BMS): BMS has no significant presence in vaccines, focusing instead on oncology and immunology, making Pfizer's vaccine leadership a unique strength. R&D Capabilities and Pipeline Focus Pfizer's R&D efforts are concentrated on high-growth therapeutic areas such as oncology, vaccines, and rare diseases. Its ability to leverage mRNA technology and rapidly develop innovative therapies underscores its R&D prowess. J&J: J&J's R&D spans pharmaceuticals, medical devices, and consumer health. While this diversification provides stability, it may dilute J&J's focus on cutting-edge pharmaceutical innovation compared to Pfizer's targeted approach. GSK: GSK excels in respiratory diseases and HIV research, but its pipeline is less broad and lacks the same level of innovation in emerging technologies like mRNA that Pfizer is advancing. BMS: BMS has a strong oncology pipeline, particularly in immuno-oncology, but its narrower focus limits its competitiveness in other high-growth areas where Pfizer thrives, such as vaccines and rare diseases. Global Reach and Market Presence Pfizer operates in over 150 countries, giving it a vast global footprint that enhances its ability to distribute products and capture market share across both developed and emerging markets. J&J: J&J also has a global presence, but its focus is split across pharmaceuticals, medical devices, and consumer health, potentially reducing its pharmaceutical market penetration compared to Pfizer. GSK: GSK is strong in Europe and emerging markets but less dominant in the U.S., the world's largest pharmaceutical market, where Pfizer has a significant advantage. BMS: BMS focuses heavily on the U.S. and Europe, with less presence in emerging markets, limiting its global scale compared to Pfizer. Brand Reputation and Trust The success of Pfizer's COVID-19 vaccine has significantly boosted its brand recognition and trust among consumers, healthcare providers, and governments, reinforcing its market position. J&J: J&J enjoys a strong reputation in consumer health, but its pharmaceutical division lacks the same level of visibility and trust as Pfizer's, particularly after COVID-19 vaccine challenges. GSK: GSK is well-regarded in respiratory and HIV treatments but does not have the broad public recognition that Pfizer has achieved. BMS: BMS is respected in oncology but lacks the widespread brand prominence that Pfizer has cultivated. Innovation in Emerging Technologies Pfizer's investment in mRNA technology positions it as a pioneer in pharmaceutical innovation, with potential applications in vaccines, cancer treatments, and more, giving it a forward-looking edge. J&J: J&J innovates in medical devices and consumer health but trails Pfizer in adopting next-generation pharmaceutical technologies like mRNA. GSK: GSK focuses on innovation in respiratory and HIV treatments but has not made significant advances in mRNA or other emerging platforms. BMS: BMS drives innovation in immuno-oncology but lacks Pfizer's breadth and leadership in cutting-edge technologies. Pfizer's competitive edge over Johnson & Johnson, GlaxoSmithKline, and Bristol Myers Squibb lies in its unmatched leadership in vaccines, particularly through mRNA technology, combined with a robust R&D pipeline, extensive global reach, substantial financial resources, strong brand reputation, and a focus on innovation. While J&J benefits from diversification, GSK from efficiency, and BMS from oncology expertise, none rival Pfizer's comprehensive strengths across these critical areas, ensuring its dominance in the pharmaceutical landscape. Pfizer's broad moat is supported by patents, economies of scale, and a strong distribution network. Strong pricing power derived from Pfizer's patent-protected medications allows the company to produce returns on investment that exceed its cost of capital. The company can develop the next generation of drugs before generic competition appears thanks to the patents. Furthermore, even though Pfizer has a wide range of products, there is some product concentration, as Prevnar accounts for slightly more than 10% of total sales (not including sales of the COVID-19 vaccine).However, because of the vaccine's complicated manufacturing process and comparatively low cost, we don't anticipate typical generic competition. Ibrance and Eliquis each account for nearly 10% of sales. On the other hand, we anticipate that new products will eventually lessen the competition from generic versions of important medications. In order to lessen the pressure on margins from lost sales of high-margin drugs, Pfizer's operating structure permits cost-cutting after patent losses. All things considered, Pfizer's well-established product line generates the massive cash flows required to cover the typical $800 million in development expenses for each new medication. For smaller pharmaceutical companies without Pfizer's resources, the company's robust distribution network positions it as a solid partner. On April 15, President Donald Trump issued an executive order outlining possible policy changes intended to reduce the cost of pharmaceuticals in the United States. The biopharma industry is looking forward to these changes because they have the potential to either help or hurt innovation. In the worst situation, international price benchmarks have the potential to drastically cut US drug prices and lessen financial incentives for international drug development. On the plus side, eliminating the "pill penalty" that only grants small molecule medications nine years of Medicare negotiation protection may promote innovation across all treatment modalities. Trump's executive order may have a positive or negative impact on the industry, but it has no effect on valuations or uncertainty ratings. The protection period is not specified in Trump's request that US Department of Health and Human Services Secretary Robert F. Kennedy Jr. collaborate with Congress to address the pill penalty, which is contingent upon Congressional action. Since innovation and a favorable mergers and acquisitions climate support long-term pricing power and offset possible short-term tariff pressure, rising tax rates, and approval delays, the biopharma industry seems undervalued. Due to liver damage in a clinical trial, Pfizer has announced the discontinuation of danuglipron, an oral small molecule GLP-1 agonist. In the anticipated $200 billion global GLP-1 market by 2031, the company sought to provide a potential second-to-market oral small molecule GLP-1 agonist, behind Lilly's orforglipron. Clinical trial failures and declining demand for Pfizer's COVID vaccine and antiviral medication have hurt the company's growth. Because of its diverse pipeline and portfolio, Pfizer is expected to have a wide-moat case, protecting it from the effects of individual program failures, especially those involving high-risk programs like danuglipron. Other medication candidates might benefit from Pfizer's objective of turning danuglipron into a once-daily business could use its $15 billion acquisition budget to fund the development of more sophisticated medication candidates. Efforts in Genetic Engineering: A solid growth driver for Pfizer is the strong pipeline of innovative treatment options, especially in oncology and immunology, which take the leap with cutting-edge scientific technology. To be more specific, Pfizer's resource allocation to immuno-oncology is evident, developing of checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) and chimeric antigen receptor T-cell (CAR-T) therapies. For instance, this method of treatment mitigates the immune system's ability to detect and destroy the specified cancer cells by varying the immune system response or, in some cases, by using specially modified T-cells that can identify the particular antigens on tumors that are solely expressed in those particular tumors, which are in question. This is the area of advancement where Pfizer has outdone the rest as they are perfecting monoclonal antibody formatsdesigning them in a way that they will bind more tightly and specifically to targets using protein engineeringand they are also testing out bispecific antibodies that trigger switches at two targets, therefore enhancing healing by more than one method. The pipeline is further supported by vast R&D investment in gene therapy and precision medicine, which utilize adeno-associated virus (AAV) vector platforms for gene delivery and next-generation sequencing for actionable mutation identification respectively. These endeavors are aimed at enhancing the overall patient health and market potential of the drugs by changing the treatment convention from testing a wide spectrum to one that is genotype-driven. Clinical trials are usually designed in a way to be fast-tracked so that they can move quickly to the next stage of development. By focusing on such advanced technologies, Pfizer is embarking on capturing a large section of the market with high-growth therapeutic branches, thus gaining revenue through innovation guided by complex disease biology. Revenue Growth: The launching of these high-value treatments is expected to increase revenue as well as drive down costs for Pfizer. Most of the drugs that are released in the onco-immunology field possess a technical edge and therapeutic effectiveness, therefore, these new treatements often demand high price. These drugs are capable of pumping up profits significantly once they clear regulatory hurdles and find their way onto the market. take the example of just-above successful immuno-oncology drug sales, which always have brisk selling and marvelous sales. In addition, Pfizer can speed-up the whole clinical process with something like adaptive trial designs, this process will be quicker and thus benefits are obtained faster from the new products. Impact on profitability The weight on profitability depends on the ratio of costs and returns. What is actually known is that lamas like the checkpoint inhibitors and CAR-T treatments that are so good require a lot of investment in R&D. But there is an inherent advantage for these drugs thanks to their patent protection that comes with market exclusivity, which in turn, allows Pfizer to keep its pricing strategy stick and generate very high profits. Success in the selling of the product along the lines of this new dimension along with the efficiency of producing more could prove to be the road to better profitability. However, there are barriers such as competition from other drug companies plus the worry of the price cuts from payers that can erode this success. So if Pfizer is able to eliminate the competition and stays ahead in the game by reducing costs as well, these high markups brought about by the introduction of such innovative drugs should positively affect the total profitability of the company. Generic competition, possible changes to government drug pricing policies, the more stringent FDA, and more powerful managed-care and pharmacy benefit managers present Pfizer with difficulties in drug development. In some disease areas, developing new drugs is getting harder, and pharmacy benefit managers and managed-care organizations have grown to be strong players with the ability to bargain for cheaper drug costs. Nearly one-fourth of the company's total sales are generated by its medications, Eliquis, Ibrance, and Xtandi, and they are heavily exposed to the Medicare channel. Given that Pfizer's product portfolio is less vulnerable to potential litigation, the company's base-case annual legal costs, assuming a 50% probability of future costs associated with product governance ESG risks, come close to 1% of non-GAAP net income. Pfizer's valuation multiples highlights their strong financial position and potential undervaluation. Their P/E Non-GAAP ratios7.61 (FY1), 7.42 (FY2), and 7.44 (FY3)are lower than JNJ's 14.00 (FY1) and SNY's 10.80 (FY1), suggesting investors may undervalue our earnings potential. The PEG Non-GAAP (FWD) of 1.49 is competitive, higher than SNY's 0.76 but below JNJ's 1.70, reflecting moderate growth prospects. Pfizer's EV/Sales (TTM) of 2.81 is more conservative than JNJ's 4.21, while the EV/EBITDA (FWD) of 7.13 compares favorably to JNJ's 11.45, indicating operational efficiency. The Price to Book (TTM) of 1.44 is significantly lower than JNJ's 5.23, and our Price to Cash Flow (TTM) of 9.29 beats JNJ's 15.67, underscoring robust cash flow generation. These metrics position Pfizer as a value opportunity among peers After the Seagen acquisition, Pfizer released its 2024 guidance, which included a $8 billion COVID-19 product guidance$5 billion less than anticipated. The business admitted that, excluding sales of COVID-19 products, it would not meet the prior growth-rate projection of 6% from 2020 to 2025. Pfizer reaffirmed its support for the dividend, which is regarded as safe and likely to boost stock valuation, despite the deteriorating outlook. Over the next ten years, the company anticipates steady sales as new products counteract older medications that are losing their patent protection. From the middle of 2023 to the end of 2024, Pfizer is anticipated to reduce operating expenses by $4 billion, which will aid the company in adjusting to the waning pandemic and declining sales of COVID-19 products. Growth could be accelerated through acquisitions, and future margin pressure could be reduced through restructuring initiatives. It is estimated that Pfizer's weighted average cost of capital is 7% and its cost of equity is 7.5%. Activist investor Jeffrey Smith's recent stake worth $407 million could presage the much needed turnarounds at Pfizer. Investors and shareholders can reasonably expect further cost-cuts and an efficient use of capital, leading to higher margins and free cashflow. This case could follow the path of Walt Disney, albeit with less drama, where Jeff Ubben of ValueAct had a pivotal role in Disney's turnaround campaign. The large-cap biopharma company Pfizer's debt size, business cyclicality, and debt maturity outlook all contribute to its sound balance sheet and low risk levels. To support opportunistic acquisitions and handle product litigation issues with little market concern, the company should have a strong enough balance sheet. Pfizer spends slightly less on R&D than the industry average, with a mid- to high-teens percentage of sales. Patent losses are offset by the company's robust pipeline of next-generation medications. The company's investment in cutting-edge new medications, mostly aimed at immunology and oncology, improves its standing and increases returns on capital. For biopharma companies in the sector, this balance sheet strength is essential. This article first appeared on GuruFocus. Sign in to access your portfolio
Yahoo
07-06-2025
- Business
- Yahoo
Patents and economies of scale support Pfizer's wide moat
Pfizer's innovative business should grow faster after it divests its off-patent division Upjohn in 2020 to create Viatris and Mylan. With fewer older medications and fewer patent losses, Pfizer is well-positioned for consistent growth, excluding the erratic sales of Covid-19-related products. The company is less vulnerable to any one patent loss thanks to its wide range of medications. Because of its more complex manufacturing process and more affordable prices, Pfizer's stronger position in the vaccine marketwhich includes the pneumococcal vaccine Prevnarmakes it more resilient to generic competition. Warning! GuruFocus has detected 6 Warning Signs with PFE. With a 30% to 80% reduction, Trump's executive order would establish a "most favored nation" policy in which the US would pay the same amount for prescription medications as the nation with the lowest price. It is anticipated that this policy, which was previously blocked by courts, will reduce the US's annual drug spending of over $400 billion, saving taxpayers over a seven-year period. Given that drug prices in the United States are high when compared to other countries, Pfizer's U.S. revenue could be drastically impacted by the 30% to 80% price cut, especially for high-margin medications. International reference pricing policies have long been opposed by the pharmaceutical industry, which claims they could hinder innovation and limit access to new companies anticipate that the order will target Medicare and may have an impact on medications not covered by Biden's Inflation Reduction Act. President Trump has said that significant tariffs on pharmaceutical products will probably be announced soon. He has also put a 90-day hold on broader tariffs for the majority of his trading partners to give them time to negotiate. Despite being mostly exempt from tariffs, the biopharma industry is preparing for a possible pharma-specific announcement that might affect global manufacturing strategies. Products made in Europe and imported into the US may be subject to the rumored 25% tariff, necessitating the construction of new facilities that will take years to complete. Due to home country manufacturing, tax benefits, lower production costs, and exposure to currency fluctuations, businesses based in the US and Europe are heavily exposed to European manufacturing. Because drug spending is not cyclical, the direct effect of tariffs on earnings is probably going to be minimal, and the indirect effect of a possible recession should also be minimal. With the exception of small-scale US capacity expansions, biopharma is unlikely to completely reevaluate its manufacturing footprint if pharmaceutical tariffs are implemented but are lifted after 2026 as a result of political pressure from the midterm elections. Leadership in Vaccines Pfizer stands out with its dominant position in vaccines, most notably its highly successful COVID-19 vaccine developed in partnership with BioNTech. This vaccine not only generated significant revenue but also established Pfizer as a leader in mRNA technology, a platform with potential applications in oncology, rare diseases, and beyond. Johnson & Johnson (J&J): J&J also developed a COVID-19 vaccine, but it was less widely adopted due to lower efficacy rates and safety concerns, giving Pfizer a clear advantage in this high-impact area. GlaxoSmithKline (GSK): GSK has a strong vaccine portfolio (e.g., shingles and meningitis vaccines) but did not independently develop a COVID-19 vaccine, relying on partnerships like Sanofi, which delayed its entry and diminished its competitive stance. Bristol Myers Squibb (BMS): BMS has no significant presence in vaccines, focusing instead on oncology and immunology, making Pfizer's vaccine leadership a unique strength. R&D Capabilities and Pipeline Focus Pfizer's R&D efforts are concentrated on high-growth therapeutic areas such as oncology, vaccines, and rare diseases. Its ability to leverage mRNA technology and rapidly develop innovative therapies underscores its R&D prowess. J&J: J&J's R&D spans pharmaceuticals, medical devices, and consumer health. While this diversification provides stability, it may dilute J&J's focus on cutting-edge pharmaceutical innovation compared to Pfizer's targeted approach. GSK: GSK excels in respiratory diseases and HIV research, but its pipeline is less broad and lacks the same level of innovation in emerging technologies like mRNA that Pfizer is advancing. BMS: BMS has a strong oncology pipeline, particularly in immuno-oncology, but its narrower focus limits its competitiveness in other high-growth areas where Pfizer thrives, such as vaccines and rare diseases. Global Reach and Market Presence Pfizer operates in over 150 countries, giving it a vast global footprint that enhances its ability to distribute products and capture market share across both developed and emerging markets. J&J: J&J also has a global presence, but its focus is split across pharmaceuticals, medical devices, and consumer health, potentially reducing its pharmaceutical market penetration compared to Pfizer. GSK: GSK is strong in Europe and emerging markets but less dominant in the U.S., the world's largest pharmaceutical market, where Pfizer has a significant advantage. BMS: BMS focuses heavily on the U.S. and Europe, with less presence in emerging markets, limiting its global scale compared to Pfizer. Brand Reputation and Trust The success of Pfizer's COVID-19 vaccine has significantly boosted its brand recognition and trust among consumers, healthcare providers, and governments, reinforcing its market position. J&J: J&J enjoys a strong reputation in consumer health, but its pharmaceutical division lacks the same level of visibility and trust as Pfizer's, particularly after COVID-19 vaccine challenges. GSK: GSK is well-regarded in respiratory and HIV treatments but does not have the broad public recognition that Pfizer has achieved. BMS: BMS is respected in oncology but lacks the widespread brand prominence that Pfizer has cultivated. Innovation in Emerging Technologies Pfizer's investment in mRNA technology positions it as a pioneer in pharmaceutical innovation, with potential applications in vaccines, cancer treatments, and more, giving it a forward-looking edge. J&J: J&J innovates in medical devices and consumer health but trails Pfizer in adopting next-generation pharmaceutical technologies like mRNA. GSK: GSK focuses on innovation in respiratory and HIV treatments but has not made significant advances in mRNA or other emerging platforms. BMS: BMS drives innovation in immuno-oncology but lacks Pfizer's breadth and leadership in cutting-edge technologies. Pfizer's competitive edge over Johnson & Johnson, GlaxoSmithKline, and Bristol Myers Squibb lies in its unmatched leadership in vaccines, particularly through mRNA technology, combined with a robust R&D pipeline, extensive global reach, substantial financial resources, strong brand reputation, and a focus on innovation. While J&J benefits from diversification, GSK from efficiency, and BMS from oncology expertise, none rival Pfizer's comprehensive strengths across these critical areas, ensuring its dominance in the pharmaceutical landscape. Pfizer's broad moat is supported by patents, economies of scale, and a strong distribution network. Strong pricing power derived from Pfizer's patent-protected medications allows the company to produce returns on investment that exceed its cost of capital. The company can develop the next generation of drugs before generic competition appears thanks to the patents. Furthermore, even though Pfizer has a wide range of products, there is some product concentration, as Prevnar accounts for slightly more than 10% of total sales (not including sales of the COVID-19 vaccine).However, because of the vaccine's complicated manufacturing process and comparatively low cost, we don't anticipate typical generic competition. Ibrance and Eliquis each account for nearly 10% of sales. On the other hand, we anticipate that new products will eventually lessen the competition from generic versions of important medications. In order to lessen the pressure on margins from lost sales of high-margin drugs, Pfizer's operating structure permits cost-cutting after patent losses. All things considered, Pfizer's well-established product line generates the massive cash flows required to cover the typical $800 million in development expenses for each new medication. For smaller pharmaceutical companies without Pfizer's resources, the company's robust distribution network positions it as a solid partner. On April 15, President Donald Trump issued an executive order outlining possible policy changes intended to reduce the cost of pharmaceuticals in the United States. The biopharma industry is looking forward to these changes because they have the potential to either help or hurt innovation. In the worst situation, international price benchmarks have the potential to drastically cut US drug prices and lessen financial incentives for international drug development. On the plus side, eliminating the "pill penalty" that only grants small molecule medications nine years of Medicare negotiation protection may promote innovation across all treatment modalities. Trump's executive order may have a positive or negative impact on the industry, but it has no effect on valuations or uncertainty ratings. The protection period is not specified in Trump's request that US Department of Health and Human Services Secretary Robert F. Kennedy Jr. collaborate with Congress to address the pill penalty, which is contingent upon Congressional action. Since innovation and a favorable mergers and acquisitions climate support long-term pricing power and offset possible short-term tariff pressure, rising tax rates, and approval delays, the biopharma industry seems undervalued. Due to liver damage in a clinical trial, Pfizer has announced the discontinuation of danuglipron, an oral small molecule GLP-1 agonist. In the anticipated $200 billion global GLP-1 market by 2031, the company sought to provide a potential second-to-market oral small molecule GLP-1 agonist, behind Lilly's orforglipron. Clinical trial failures and declining demand for Pfizer's COVID vaccine and antiviral medication have hurt the company's growth. Because of its diverse pipeline and portfolio, Pfizer is expected to have a wide-moat case, protecting it from the effects of individual program failures, especially those involving high-risk programs like danuglipron. Other medication candidates might benefit from Pfizer's objective of turning danuglipron into a once-daily business could use its $15 billion acquisition budget to fund the development of more sophisticated medication candidates. Efforts in Genetic Engineering: A solid growth driver for Pfizer is the strong pipeline of innovative treatment options, especially in oncology and immunology, which take the leap with cutting-edge scientific technology. To be more specific, Pfizer's resource allocation to immuno-oncology is evident, developing of checkpoint inhibitors (e.g., PD-1/PD-L1 inhibitors) and chimeric antigen receptor T-cell (CAR-T) therapies. For instance, this method of treatment mitigates the immune system's ability to detect and destroy the specified cancer cells by varying the immune system response or, in some cases, by using specially modified T-cells that can identify the particular antigens on tumors that are solely expressed in those particular tumors, which are in question. This is the area of advancement where Pfizer has outdone the rest as they are perfecting monoclonal antibody formatsdesigning them in a way that they will bind more tightly and specifically to targets using protein engineeringand they are also testing out bispecific antibodies that trigger switches at two targets, therefore enhancing healing by more than one method. The pipeline is further supported by vast R&D investment in gene therapy and precision medicine, which utilize adeno-associated virus (AAV) vector platforms for gene delivery and next-generation sequencing for actionable mutation identification respectively. These endeavors are aimed at enhancing the overall patient health and market potential of the drugs by changing the treatment convention from testing a wide spectrum to one that is genotype-driven. Clinical trials are usually designed in a way to be fast-tracked so that they can move quickly to the next stage of development. By focusing on such advanced technologies, Pfizer is embarking on capturing a large section of the market with high-growth therapeutic branches, thus gaining revenue through innovation guided by complex disease biology. Revenue Growth: The launching of these high-value treatments is expected to increase revenue as well as drive down costs for Pfizer. Most of the drugs that are released in the onco-immunology field possess a technical edge and therapeutic effectiveness, therefore, these new treatements often demand high price. These drugs are capable of pumping up profits significantly once they clear regulatory hurdles and find their way onto the market. take the example of just-above successful immuno-oncology drug sales, which always have brisk selling and marvelous sales. In addition, Pfizer can speed-up the whole clinical process with something like adaptive trial designs, this process will be quicker and thus benefits are obtained faster from the new products. Impact on profitability The weight on profitability depends on the ratio of costs and returns. What is actually known is that lamas like the checkpoint inhibitors and CAR-T treatments that are so good require a lot of investment in R&D. But there is an inherent advantage for these drugs thanks to their patent protection that comes with market exclusivity, which in turn, allows Pfizer to keep its pricing strategy stick and generate very high profits. Success in the selling of the product along the lines of this new dimension along with the efficiency of producing more could prove to be the road to better profitability. However, there are barriers such as competition from other drug companies plus the worry of the price cuts from payers that can erode this success. So if Pfizer is able to eliminate the competition and stays ahead in the game by reducing costs as well, these high markups brought about by the introduction of such innovative drugs should positively affect the total profitability of the company. Generic competition, possible changes to government drug pricing policies, the more stringent FDA, and more powerful managed-care and pharmacy benefit managers present Pfizer with difficulties in drug development. In some disease areas, developing new drugs is getting harder, and pharmacy benefit managers and managed-care organizations have grown to be strong players with the ability to bargain for cheaper drug costs. Nearly one-fourth of the company's total sales are generated by its medications, Eliquis, Ibrance, and Xtandi, and they are heavily exposed to the Medicare channel. Given that Pfizer's product portfolio is less vulnerable to potential litigation, the company's base-case annual legal costs, assuming a 50% probability of future costs associated with product governance ESG risks, come close to 1% of non-GAAP net income. Pfizer's valuation multiples highlights their strong financial position and potential undervaluation. Their P/E Non-GAAP ratios7.61 (FY1), 7.42 (FY2), and 7.44 (FY3)are lower than JNJ's 14.00 (FY1) and SNY's 10.80 (FY1), suggesting investors may undervalue our earnings potential. The PEG Non-GAAP (FWD) of 1.49 is competitive, higher than SNY's 0.76 but below JNJ's 1.70, reflecting moderate growth prospects. Pfizer's EV/Sales (TTM) of 2.81 is more conservative than JNJ's 4.21, while the EV/EBITDA (FWD) of 7.13 compares favorably to JNJ's 11.45, indicating operational efficiency. The Price to Book (TTM) of 1.44 is significantly lower than JNJ's 5.23, and our Price to Cash Flow (TTM) of 9.29 beats JNJ's 15.67, underscoring robust cash flow generation. These metrics position Pfizer as a value opportunity among peers After the Seagen acquisition, Pfizer released its 2024 guidance, which included a $8 billion COVID-19 product guidance$5 billion less than anticipated. The business admitted that, excluding sales of COVID-19 products, it would not meet the prior growth-rate projection of 6% from 2020 to 2025. Pfizer reaffirmed its support for the dividend, which is regarded as safe and likely to boost stock valuation, despite the deteriorating outlook. Over the next ten years, the company anticipates steady sales as new products counteract older medications that are losing their patent protection. From the middle of 2023 to the end of 2024, Pfizer is anticipated to reduce operating expenses by $4 billion, which will aid the company in adjusting to the waning pandemic and declining sales of COVID-19 products. Growth could be accelerated through acquisitions, and future margin pressure could be reduced through restructuring initiatives. It is estimated that Pfizer's weighted average cost of capital is 7% and its cost of equity is 7.5%. Activist investor Jeffrey Smith's recent stake worth $407 million could presage the much needed turnarounds at Pfizer. Investors and shareholders can reasonably expect further cost-cuts and an efficient use of capital, leading to higher margins and free cashflow. This case could follow the path of Walt Disney, albeit with less drama, where Jeff Ubben of ValueAct had a pivotal role in Disney's turnaround campaign. The large-cap biopharma company Pfizer's debt size, business cyclicality, and debt maturity outlook all contribute to its sound balance sheet and low risk levels. To support opportunistic acquisitions and handle product litigation issues with little market concern, the company should have a strong enough balance sheet. Pfizer spends slightly less on R&D than the industry average, with a mid- to high-teens percentage of sales. Patent losses are offset by the company's robust pipeline of next-generation medications. The company's investment in cutting-edge new medications, mostly aimed at immunology and oncology, improves its standing and increases returns on capital. For biopharma companies in the sector, this balance sheet strength is essential. This article first appeared on GuruFocus.
Medscape
02-06-2025
- Business
- Medscape
UK Pharmacies Struggle with Severe Creon Shortage
Nearly all UK pharmacies are experiencing severe 'challenges' supplying pancreatic enzyme replacement therapy (PERT), the National Pharmacy Association (NPA) warned. A sample survey by the association found that 96% of pharmacies were struggling to obtain Creon (pancrelipase, Mylan). A further 89% reported difficulties supplying PERT alternatives. Patients Resorting to Extreme Measures The ongoing shortage has forced patients to take desperate action, according to the NPA, which said some are rationing existing medication supplies or skipping meals entirely. One pharmacist described it as the 'worst stock shortage' they had ever encountered. Patients report eating only one meal daily, contacting multiple pharmacies for supplies, or travelling more than 30 miles to obtain the medication. Critical Medication for Serious Conditions Creon is used to treat pancreatic exocrine insufficiency from a variety of causes, including pancreatic cancer, cystic fibrosis, and pancreatitis. The medication, derived from porcine pancreatin, contains lipase, protease, and amylase. It dissolves rapidly in the stomach to release its enzyme load in the small intestine, where its lipolytic, amylolytic, and proteolytic activity enable absorption of the products of pancreatic digestion. PERT medications need to be taken to facilitate digestion every time a patient eats. In clinical trials, treatment with Creon markedly improved stool consistency, abdominal pain, and stool frequency, independent of the underlying disease. The consequences of inadequate dosing can be severe. Patients may become too unwell for surgery, struggle with chemotherapy tolerance, or experience debilitating symptoms that diminish quality of life. Symptoms may include diarrhoea, flatulence, bloating, abdominal pain, unexplained weight loss, and oily, foul-smelling stools (steatorrhoea). Safety Concerns Olivier Picard, NPA chair, warned the shortage has 'profound effects' on patients who depend on the medication to survive and lead normal lives. 'It simply cannot be right that in the 21st century patients are skipping meals in order to ration their medication,' he said. Last week, the government extended the current Serious Shortage Protocol (SSP) for Creon until 21 November 2025. The protocol allows pharmacists to use professional judgement to decide whether it's 'reasonable and appropriate' to substitute a patient's prescription for an alternative agent for one dispensing month. It allows pharmacies to supply a reduced quantity of Creon capsules that might be in stock, without having to send a patient back to their GP to get a new prescription. Two SSPs for Creon 10,000 and 25,000 capsules have been in place since May 2024. However, the survey found that 81% of pharmacies felt the current arrangements for managing the shortage were inadequate. In particular, pharmacists were still obliged to refer patients back to prescribers when seeking PERT alternatives. Alternative PERT formulations Nutrizym and Pancrex are also now in short supply as manufacturers struggle to meet demand. GPs and pharmacies can order unlicensed Creon or other PERT products from overseas, but other countries have experienced similar shortages. Calls for Regulatory Change The NPA and Pancreatic Cancer UK issued a joint statement urging government action. They called for a national plan to address shortages and support patients with alternative care. Picard said that although the situation was complex and not the fault of the government, medicine shortages were all too common. 'Highly trained pharmacists should also be permitted to use their professional judgment to supply alternative medicines — where it is safe and appropriate — in the event of the prescribed version being unavailable.' Alfie Bailey-Bearfield, head of influencing and health improvement at Pancreatic Cancer UK, said that the findings were 'deeply worrying'. It was 'totally unacceptable' that cancer patients were still taking desperate measures that put their health, wellbeing, and eligibility for treatment at risk, when the charity had been raising concerns with Department of Health and Social Care (DHSC) officials and PERT suppliers for more than a year. 'This crisis continues to put people's health on the line, and they cannot afford to wait any longer,' he said. A DHSC spokesperson said that the supply issues with Creon were European-wide and caused by limited availability of raw ingredients along with manufacturing capacity constraints. 'We are working closely with industry and the NHS to mitigate the impact on patients and resolve the issues as quickly as possible,' the spokesperson said.
Reuters
01-06-2025
- Business
- Reuters
In-House Counsel File Practical Law The Journal
Career in Brief Experience: 2014–present: Verizon Communications Inc. (2017–present: Associate General Counsel & Director, Policy, Corporate Social Responsibility, Information Security, Legal and Security Department; 2014–2017: Assistant General Counsel & Director, Public Policy, Law and Security Department); 2011–2013: Ferring Pharmaceuticals Inc., Assistant General Counsel; 2010–2011: Mylan Specialty L.P. (formerly Dey Pharma, L.P.), Associate Counsel; 2009–2010: Biomet, Inc., Corporate Counsel, Commercial Transactions; 2002–2008: Schering-Plough Corporation, Senior Counsel; 2000–2002: Update Legal, Inc., Attorney. Education: 2000: J.D., Thurgood Marshall School of Law; 1997: Comparative Law studies, University of Oxford; 1993: H.B.A. (Industrial Relations and Economics), University of Toronto. Location of Company HQ: New York City. Primary Industry Sector: Technology and Telecommunications. Revenues in the Last Financial Year: $134.8 billion. Number of Attorneys Worldwide: 410 attorneys. Legal Department Locations: Basking Ridge, New Jersey; Alpharetta, Georgia; Irving, Texas; Washington, DC; Dublin, Ireland; Readington, England. How is the legal function structured? The legal function is structured by practice area, such as litigation, regulatory, compliance, employment, information technology, and security, as well as by business area, such as procurement, marketing, and sales. What is the top area of focus for the legal department? We are focused on delivering quality, ethical support to the business units to realize company-wide goals while remaining compliant with the Verizon Code of Conduct and industry regulations. It is imperative to remain apprised and aware of changing legal requirements. The legal department is agile, knowledgeable, and conscientious about being compliant. For example, any changes to employment laws are reviewed and implemented in compliance with industry requirements. What role do you play in Verizon's compliance program given the ever-changing regulatory environment? I make sure to stay up to date on the various regulatory requirements to effectively advise the different groups I support, including by taking training courses on the latest developments affecting our organization. How do you manage privilege and confidentiality concerns when communicating with employees? Employees in certain key areas sign non-disclosure agreements with respect to material, non-public information. Any privileged communications are marked as such when communicating with employees. Verizon maintains strict controls over the privacy of its information when disseminating the same, whether internally or externally with partners. What are some approaches that Verizon has taken to prioritize diversity? Verizon hires employees from various communities and geographies that reflect its customer base. There are several employee resource groups (ERGs) for different groups of employees, such as veterans, disabled or neurodivergent individuals, women, Latin Americans, South and East Asians, and African Americans, so that employees feel valued, appreciated, and heard. Each one of these ERGs is sponsored by a senior executive. As law departments' responsibilities evolve, what skills or competencies should in-house counsel develop to support the company's legal and operational needs? In-house counsel should develop a solid understanding of how businesses operate in specific industries, as well as an in-depth knowledge of financial principles and regulatory requirements and guidelines. What role do you see AI playing in the legal field over the next few years? Even now, I see AI becoming prevalent in the legal field, including in facilitating daily work operations such as accessing, analyzing, and utilizing information efficiently. AI cannot be avoided, but controls and parameters need to be established to prevent the unlawful dissemination of information and protect the privacy of customer information. What three things does a law firm need to do to impress you? A law firm needs to: What advice would you give to a prospective in-house counsel? Be responsive and communicative. Additionally, complete tasks thoroughly and on time in compliance with business needs and goals. What is a challenge you have faced in your role and what did you learn from it? One challenge I faced was learning to reconcile urgent business requests with established processes and protocols to remain compliant with the Verizon Code of Conduct. I learned that consistent compliance establishes known standards and this, in turn, makes legal review more efficient. If not an attorney, what would you wish to be? A motivational speaker. What are your hobbies? Traveling, fundraising for non-profits, and mentoring youth. What is your favorite book? Ruth Bader Ginsburg: A Life by Jane Sherron de Hart.
