Franklin Biotechnology Discovery Fund Q2 2024 Commentary

seekingalpha08-20

Global equities saw gains in 2Q24 driven by enthusiasm for AI, economic optimism, and potential rate cuts in the US and UK.Emerging market equities outperformed global index, while health care stocks ...

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Renewed optimism about an economic soft landing in many regions, an interest-rate cut in the eurozone, and investor expectations for potential rate cuts in the United Kingdom and the United States during the second half of this year also aided investor sentiment. As measured by MSCI indexes in US-dollar terms, emerging market equities outperformed a global index, while developed and frontier market equities underperformed it. Global growth stocks significantly outperformed global value stocks. Health care equities lagged the broader stock market averages but still ended 2Q24 in fourth place out of 11 sectors globally; a modest June rally lifted their standing after the group spent the first five months of 2024 in the back half of the rankings. Biotechnology and pharmaceuticals companies led the sector higher in the spring quarter. In contrast, the life sciences tools and services industry fell into negative territory despite collectively rising to 2024 highs in mid-May, and this subgroup is still sitting well below the all-time highs reached in September 2021. Overarching investor sentiment played a role as health care stocks, often viewed as defensive, were not favored by those who preferred large-capitalization growth stocks, particularly AI plays. There were important competing factors within the sector, too—some of the underperformance was linked to disruption as the excitement around a new class of blood sugar management and weight-loss drugs (GLP-1s, or glucagon-like peptide-1 agonists) has created a divide, with drug innovators seeing significant gains while providers of traditional treatments for diabetes and obesity have come under pressure. Several companies in the sector have what many analysts believe are weak fundamentals, with biotech companies generally rising against the contention of downside catalysts, including the delay of expected interest- rate reductions and the US Federal Reserve’s higher-for-longer stance (lower interest rates tend to spur investment in the industry). However, there were some positive company-specific developments, especially in the areas of weight loss and antipsychotic medications, backed by promising clinical trials. More broadly, sentiment is being buoyed by the shift in biopharma business activity as reports underscored a 2024 surge in IPOs (initial public offerings) and M&A (mergers and acquisitions), which investors welcomed. Some of this uptick can be attributed to companies that are exploring new strategies and products to offset potential revenue losses linked to patent cliffs and the implementation of the US Inflation Reduction Act. Quarterly Key Performance Drivers     Stocks Industries   HELPED Insmed (Significant Overweight) Health Care Services (Overweight)   Alpine Immune Sciences (Significant Overweight) —   Merus (Significant Overweight) —   HURT EyePoint Pharmaceuticals (Significant Overweight) Pharmaceuticals (Stock Selection)   Marinus Pharmaceuticals (Significant Overweight) Biotechnology (Stock Selection, Underweight)   Applied Therapeutics (Off-Benchmark Exposure) Life Sciences Tools and Services (Stock Selection)  \nClick to enlarge Overall stock selection was almost entirely responsible for the fund’s 2Q24 underperformance versus the NASDAQ Biotechnology Index. Biotech industry investments (nearly 78% of the portfolio, on average) collectively advanced, but their relative results were dampened by steep losses in overweighted or off-benchmark detractors like Applied Therapeutics (APLT), Apogee Therapeutics (APGE), Spyre Therapeutics (SYRE) and Ascendis Pharma (ASND). Applied Therapeutics reported a failed clinical trial in young diabetic cardiomyopathy patients with a high risk of overt heart failure. This outcome, financing activities that raised concerns about dilution for existing shareholders, and downgraded analyst projections contributed to the stock selloff. The fund’s lack of investments in United Therapeutics and Moderna—the latter being one of the heavier index components at 5.1% of the whole—also worsened the fund’s results, with Moderna’s shares buoyed by the US Food & Drug Administration ('FDA') approval for a respiratory virus vaccine, along with the announcement of its expanded partnership with OpenAI (not a fund holding) to analyze clinical data and operations. We would expect to see more of these kinds of partnerships. In general, the biopharma space has been experiencing rising costs while being buoyed somewhat by the broader adoption of technology, particularly AI and machine learning ('ML'), as businesses adapt to the need for clean data libraries, evolving patient demographics and changing care delivery models amid efforts to enhance the precision and efficiency of health care delivery. Pharmaceutical stocks averaged just over 14% of the portfolio and fared much worse than those tracked by the index as nearly all of them sold off, including significant overweight stakes in EyePoint Pharmaceuticals (EYPT), Marinus Pharmaceuticals (MRNS) and Revance Therapeutics (RVNC). EyePoint shed more than half of its equity value on weak data from an exploratory Phase 2 trial in a retinal disease called NPDR (non-proliferative diabetic retinopathy), which arises from complications with diabetes. The trial failed to show an appreciable benefit over placebo, a finding that echoed competitor Ocular Therapeutix’s (OCUL, also held by the fund) similar findings in mid-April, an event that sent EyePoint’s shares sharply lower at the time. We think EyePoint was smart about financing and raised enough money to comfortably get beyond this negative readout. EyePoint still has several upcoming catalysts from promising lead candidates. For example, it was on track to initiate the Phase 3 pivotal non-inferiority trial of DURAVYU in wet age-related macular degeneration in the second half of 2024, while topline data for the Phase 2 trial in diabetic macular edema is expected in the first quarter of 2025. Marinus, specializing in neuropsychiatric therapeutics, fared even worse than Eyepoint, rapidly erasing most of its share value following poor results from a Phase 3 trial of intravenous ganaxolone as a treatment for refractory status epilepticus (a.k.a. RSE, a severe condition in which seizures do not respond to first-line and second-line antiseizure medications). Marinus was hoping the drug would meet the criteria for an early conclusion to the trial, but there was uncertainty about its efficacy. Without meeting the early stopping criteria, there won’t be any final results from the Phase 3 trial until later this summer. We are closely monitoring further developments and the upcoming Phase 3 trial. On the upside, relative and absolute returns in the biotech industry were buoyed foremost by big rallies in Insmed (INSM), Alpine Immune Sciences, Merus (MRUS), Oruka Therapeutics, Benitec Biopharma (BNTC), Mirum Pharmaceuticals (MIRM), Zealand Pharma (OTCPK:ZLDPF, purchased during the period) and more. Insmed’s stock more than doubled in value after it revealed promising results from a Phase 3 study of its experimental treatment for symptoms in patients with a rare lung disease. The biopharmaceutical firm said the drug brensocatib significantly reduced pulmonary exacerbations for those suffering from non-cystic fibrosis bronchiectasis. Insmed plans to apply for FDA approval in 4Q24 and hopes to have brensocatib in the US market by mid-2025, followed by launches in Europe and Japan in the first half of 2026. Alpine Immune Sciences (not held at period-end) announced it would be acquired by Vertex Pharmaceuticals (also held by the fund) for US$4.9 billion in cash—a 67% premium to Alpine’s stock price ahead of the deal, which was completed in May. We think this is a step in the right direction strategically, as Vertex has not diversified away from cystic fibrosis, and with US$14 billion of cash on its balance sheet, Vertex could be more acquisitive than it has been. Clinical-stage oncology-focused biotech Merus fared well on key petosemtamab (peto) efficacy and safety data; the drug is in development for head and neck squamous cell carcinoma (cancer), and we believe this next data update should reinforce its quality profile. Merus offers a best-in-class asset with blockbuster potential in head and neck cancer and a differentiated antibody discovery platform. Assuming clinical and regulatory success, peto could potentially represent a US$3+ billion peak sales opportunity, according to our analysis. Additionally, positive peto data could drive further M&A speculation, as this is what we would deem a clinically “derisked,” high-value asset that would make sense as a tuck-in acquisition for any pharma company with a PD1 inhibitor (a type of cancer immunotherapy drug that blocks the activity of the PD-1 protein on immune cells, particularly T cells). As a specialist, Merus’s pipeline is focused on the discovery and development of Multiclonics, which are antibodies that simultaneously bind two (bispecifics, or “Biclonics”) or three targets (trispecifics, or “Triclonics”). Elsewhere in the portfolio, our solitary investment in the health care services industry—precision oncology testing specialist Guardant Health (GH) —was another strong contributor as it reported a 31% revenue growth in 1Q24 driven by further peer-reviewed validation of its innovative suite of cancer testing products, strong clinical and biopharma sales volumes, and increased full-year 2024 guidance. For its part in supporting fund performance, our new investment in mid-capitalization biotech Zealand’s share price surged on the announcement of positive Phase 1B weight loss and tolerability data for its amylin agonist petrelintide. According to our analysis, petrelintide has early signs of being a legitimate competitor to the GLP-1 and GLP-1/GIP (glucose- dependent insulinotropic polypeptide) agonists that are popular right now. The company indicated that early data showed the potential weight loss is comparable and tolerability is favorable. We think many investors may be underappreciating the potential that petrelintide might combine well with another of the company’s GLP-1/glucagon dual agonists, survodutide, for a compounding effect. Zealand’s next step is the initiation of a Phase 2 study later this year with data expected sometime in the first half of 2026. Outlook & Strategy The portfolio continues to be overweighted in mid-, small- and micro-capitalization biotechnology stocks as these market-capitalization tiers are where we see the best value. We also continue to emphasize selectivity, favoring what we believe to be clinically or commercially “derisked” assets. Our positive outlook is based on strong fundamentals backed in part by innovation in new drug modalities, an accommodative FDA, the continuation of what see as a strong M&A cycle, relatively stable Medicare drug reimbursement, and appealing valuations. Conversely, we remain cognizant of risks to biopharma innovation and stock performance linked to the persistence of inflation and the declining magnitude of interest-rate cuts in the United States for the remainder of 2024. We are also concerned about the possibility of cooling M&A activity and the potential for a worse-than-expected impact from the implementation of Inflation Reduction Act (IRA) drug pricing measures in the United States. The current US drug reimbursement scenario is undergoing significant changes, particularly with the introduction of new models for cell and gene therapies. The US Centers for Medicare & Medicaid Services has proposed increasing the new technology add-on payment for these therapies, which could potentially improve the profitability of biotech companies involved in developing such treatments. Moreover, the industry is also facing challenges due to dynamic pricing pressures and the need for novel payment mechanisms that reflect the full value of transformative therapies. While there are efforts to improve the reimbursement landscape for innovative therapies, which could benefit biotech companies, there are also significant challenges that could impact profitability. The industry must navigate these changes carefully to maintain a balance between innovation, patient access and financial sustainability. Big drugmakers want to deepen their product pipelines as the approaching “patent cliff” and policies linked to the IRA threaten future revenue, with an estimated US$200 billion in annual patent-related revenue at risk through 2030. The Medicare Drug Price Negotiation Program embedded in the IRA legislation could cause a big drop in the prices at which drugs are reimbursed, creating a “functional” patent expiration. These dynamics are increasingly driving large pharma companies’ ambitions to fill looming revenue holes through bolt-on acquisitions of late-stage drug developers and commercial biotech companies. The recent uptick in health care sector M&A activity could continue to provide a tailwind as capital constraints put pressure on smaller or early- stage companies and intensifying drug reimbursement pressures and patent-exclusivity losses impact larger commercial enterprises. We anticipate an industry consolidation-driven inflection point resulting from these pressures. These and other market-volatility factors hold the potential to increase the cost required to develop new products and could have significant implications for commercial and portfolio strategies going forward. Biotech IPO (initial public offering) volume is improving but it still isn’t where it was before the 2022–2023 biotech stock downturn. In conjunction with depressed private equity and venture capital funding, biotech remains in a rough patch as investors are holding out for more proof-of- concept and clinical trial results. We believe these capital constraints are leading small-cap and start-up companies to seek funding and growth opportunities through other avenues, such as M&A activity with larger firms. The road ahead for biotechnology and pharmaceuticals may be different from that of prior years, but these industries are not lacking innovation prospects despite consolidation. We are enthusiastic about progress in the areas of radiopharmaceuticals and antibody drug conjugates. We also see how further progress in the fields of cell therapy, gene therapy and gene editing can allow the industry to address diseases in areas of significant unmet medical need. GLP-1 (glucagon-like peptide 1) agonists and weight-loss treatments are another area of interest as the consumer fervor around these drugs rapidly expanded the market in 2023, with sales accelerating again during the first half of 2024. Alongside the biotech and pharma spheres, we are encouraged by what we are seeing in background processes, as novel discovery tools and the adoption of AI and machine learning ('ML') technologies are enabling faster and more rational drug discovery and development. While still in the early stages, the adoption of AI/ML tools in drug discovery is expected to grow rapidly in the near term. We believe AI/ML offers the potential to identify novel targets that were previously thought to be “undruggable,” as well as improve drug design by simulating molecular behavior and interactions. We believe that, over the long term, investment in the biotechnology industry should lead to a potentially strong performance. The biopharmaceutical business model benefits from wide intellectual property moat (i.e., competitive advantage over other firms), strong pricing power and high profit margins. Global pharmaceutical expenditures are growing at an above-GDP (gross domestic product) rate and are relatively insulated from fluctuations in the business cycle. This is supported by the aging of developed country populations and the dynamic that older individuals consume far more pharmaceuticals than younger ones. Lastly, innovative new drug platforms and technologies are broadening the market opportunity in areas that still have significant unmet medical needs, outpacing the loss of revenues to patent expirations and legislated price cuts.   Fund Details   Inception Date 09/15/1997   Benchmark NASDAQ Biotechnology Index, S&P 500 Index  \nClick to enlarge Fund Description The fund seeks capital appreciation by investing at least 80% of its net assets in securities of biotechnology companies and discovery research firms including those involved in fields such as genomics, genetic engineering, and gene therapy, as well as health care, pharmaceuticals and agriculture. Performance Data Average Annual Total Returns 1(%) at NAV     1 Mth 3 Mths 1 Year 5 Year Since Inception Inception Date   Advisor Class - With Sales Charges a,b 2.53 -1.83 26.45 5.91 10.11 09/15/1997   Advisor Class - Without Sales Charges a,b 2.53 -1.83 26.45 5.91 10.11 09/15/1997   Class A - With Sales Charges a -3.13 -7.28 19.20 4.46 9.72 09/15/1997   Class A - Without Sales Charges a 2.51 -1.88 26.13 5.65 9.95 09/15/1997   NASDAQ Biotechnology Index 3.28 2.60 11.49 5.80 10.39 -   S&P 500 Index 3.59 4.28 24.56 15.04 8.86 -   Performance data quoted represents past performance, which does not guarantee future results. Current performance may be lower or higher than the figures shown. Principal value and investment returns will fluctuate, and investors’ shares, when redeemed, may be worth more or less than the original cost. Performance would have been lower if fees had not been waived in various periods. Total returns assume the reinvestment of all distributions and the deduction of all fund expenses. Returns for periods of less than one year are not annualized. All classes of shares may not be available to all investors or through all distribution channels. For current month-end performance, please call Franklin Templeton at (800) DIAL BEN/(800) 342-5236 or visit www.franklintempleton.com. An investor cannot invest directly in an index, and unmanaged index returns do not reflect any fees, expenses or sales charges. Share Class Details         Sales Charges   Expenses     CUSIP Ticker Max CDSC Gross Net   Advisor Class 354713398 FTDZX – – 0.82% 0.82%   Class A 354713844 FBDIX 5.50% – 1.07% 1.07%  \nClick to enlarge  The NASDAQ Biotechnology Index is a modified capitalization-weighted index designed to measure performance of all NASDAQ stocks in the biotechnology sector. Source: Nasdaq OMX. The S&P 500 Index features 500 leading U.S. publicly traded companies, with a primary emphasis on market capitalization. Source: © S&P Dow Jones Indices LLC. All rights reserved. \nClick to enlarge \nClick to enlarge  Original Post Editor's Note: The summary bullets for this article were chosen by Seeking Alpha editors.Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. Please be aware of the risks associated with these stocks.","kind":null,"is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":1,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; +claudebot@anthropic.com)","isDev":false,"isTTM":true,"deviceId":"web-server-community-laohu8-v3","version":"4.29.1","shortVersion":"4.29.1","platform":"web","vendor":"web","appName":"ttm","isIOS":false,"isAndroid":false,"isTiger":false,"isTHS":false,"isWeiXin":false,"isWeiXinMini":false,"isWeiBo":false,"isQQ":false,"isBaiduSwan":false,"isBaiduBox":false,"isDingTalk":false,"isToutiao":false,"isOnePlus":false,"isHuaWei":false,"isXiaomi":false,"isXiaomiWebView":false,"isOppo":false,"isVivo":false,"isSamsung":false,"isMobile":false},"href":"/m/news/2460886620"}