VRTX Stock Overview
Vertex Pharmaceuticals Incorporated, a biotechnology company, engages in developing and commercializing therapies for treating cystic fibrosis.
Vertex Pharmaceuticals Incorporated Competitors
Price History & Performance
|Historical stock prices|
|Current Share Price||US$289.54|
|52 Week High||US$305.95|
|52 Week Low||US$176.36|
|1 Month Change||-0.23%|
|3 Month Change||0.77%|
|1 Year Change||60.54%|
|3 Year Change||67.93%|
|5 Year Change||86.68%|
|Change since IPO||6,334.22%|
Recent News & Updates
Vertex in licensing agreement with MaxCyte to use platform for gene editing candidate
MaxCyte (NASDAQ:MXCT) has signed a non-exclusive licensing deal with Vertex Pharmaceuticals (NASDAQ:VRTX) allowing the latter to use MaxCyte's (MXCT) Flow Electroporation technology and ExPERT™ platform to develop gene-edited therapy exa-cel, previously known as CTX001. Exact financial terms were not disclosed. Exa-cel is an investigational ex vivo CRISPR/Cas-9 gene-edited cell therapy under investigation for transfusion-dependent beta thalassemia or sickle cell disease. MaxCyte's (MXCT) technology was also used in an agreement between the company and CRISPR Therapeutics (CRSP). Vertex is developing exa-cel, currently in phase 2/3, with CRISPR (CRSP). Seeking Alpha's Quant Rating views MaxCyte as a hold with high marks for growth and momentum.
Vertex Pharmaceuticals: Clinical Data Supports A Favorable Long-Term Growth Outlook
Summary Vertex shares may be undervalued, as DCF analysis suggests little value is assigned to the pipeline. Vertex has a remarkably profitable CF franchise, but the quality advancing pipeline offers an opportunity for substantial growth over a 5-10 year time frame. The company produced positive phase 2 data in acute pain and is on track to initiate phase 3 studies. Summary A year ago, Vertex Pharmaceuticals (VRTX) shares sold off after setbacks in the pipeline brought into question whether the company could expand beyond their extraordinary CF franchise. Since then, data readouts in multiple programs have occurred which has significantly de-risked the pipeline. Longer term, Vertex has multiple paths to significant, sustainable growth. This article is an overview of some of the pipeline assets which may offer growth and a detailed analysis of VX-548 in pain. VX-548 has the potential to have monopoly-like status, command premium pricing, and generate billions in revenue. The Pipeline and the Growth Trajectory for Vertex Proof of concept data for Exa-cel in sickle cell disease and transfusion-dependent thalassemia has put Vertex on track to submit an MAA to the EU in Q422. Discussions with FDA are ongoing. This is likely to be the next approved product slated to begin generating sales in as early as 2023. VX-147 in APOL1-mediated kidney disease is in pivotal development. There are approximately 100k patients who may benefit from treatment. If the interim analysis of eGFR slope and proteinuria reduction from baseline at 48 weeks is positive, accelerated approval is possible. A data readout from the interim analysis is on track for 2023. VX-147 may be the next leg of growth where sales may begin in late 2024. The early-stage type 1 diabetes program produced promising data. VX-880 is a stem cell-derived islet replacement therapy. It holds the potential to provide a functional cure for diabetes. Two patients were treated at half the target dose and showed excellent results. The first patient achieved insulin independence which was sustained and the second patient had significant reductions in exogenous insulin requirements. An additional patient received the full target dose and data should be available soon. These patients were on immunosuppressive drugs, and there are significant technical challenges to enable treatment without immunosuppressants. The company also seeks to treat T1 diabetes in patients who are not taking immunosuppressants. Vertex is on the path to file an IND for its islet cells and device program in 2H22. Recently, Vertex bought ViaCyte, a private company that was a competitor also attempting to develop a functional cure for type 1 diabetes for $320 m. In my view, this was a very low price for significant technologies and expertise that will help to overcome the challenges of developing a functional cure. This acquisition allows Vertex to add scientists who have focused on this endeavor for years as well as manufacturing expertise for cell-based therapies. ViaCyte has developed devices designed to protect the cells from the immune system. Lastly, in partnership with CRISPR Therapeutics (CRSP), ViaCyte developed gene edited cells (VCTX210) which are designed to evade the immune system, and if effective, would eliminate the need for immunosuppressive therapy. Essentially, this acquisition gave Vertex additional tools allowing them to find the best approach for patients. ViaCyte (ViaCyte) Acute Pain and Opioids Opioid abuse and addiction are a public health crisis. The CDC reported there were 69,000 deaths in 2020 from opioid overdoses. Despite a growing understanding of the dangers and addictive potential of opioids, prescribing and overdosing are continuing. The epidemic shows no signs of abating given the CDC's latest estimate rose to 75,000 Americans dying from opioid overdoses. According to the CDC, more than 2 million Americans are misusing or addicted to opioids. One explanation for why this continues is that there are no effective alternative medicines. Most prescriptions for moderate to severe acute pain are currently written for generic opioids. Many attempts to develop non-opioid pain medicines, including Vertex's own efforts (VX-150, VX-128 and VX-961), have failed to show an optimal profile. Thus, opioids continue to be a first-line treatment for moderate to severe acute pain. While opioids are an antiquated and imperfect solution, they are highly effective. Side effects including sedation, dizziness, nausea, vomiting and constipation are common. Complications of chronic opioid use include hearing loss, tolerance (more of the opioid is needed over time to produce the same level of pain relief), and addiction. Unfortunately, even short-term use has been shown to have the potential for causing addiction. There is a very real unmet need for alternative medicines to treat pain. VX-548 has a Novel Mechanism of Action VX-548 was developed based on learnings from families in Pakistan with an inability to experience pain. Due to a genetic abnormality, members of these families walk on hot coals, stab themselves with knives and jump from heights and experience no pain. This genetic mutation prevents pain signals from being sent from the peripheral nervous system to the brain. Vertex and other developers have attempted to develop medicines that mimic the pain blocking that results from this genetic abnormality. VX-548 is a selective NaV1.8 inhibitor whose mechanism of action is blocking peripheral neurons from transmitting pain signals to the brain. Opioids differ in that they work directly on receptors in the brain. Crucially, since VX-548 works in the peripheral nervous system and on a receptor which is not expressed in the brain, it does not have the addictive potential of opioids. The non-addictive potential is a significant benefit, and premium pricing is likely justified if VX-548 is successfully developed. The current market for acute pain medicine is $4B annually, and that figure is based on generic pricing. Given the pricing of a branded product would likely be at least double, the commercial opportunity is extremely large. Clinical studies are designed to achieve a broad label for a moderate to severe acute pain indication while positioning VX-548 for patients who fail to achieve relief with OTC medicines but before opioids are prescribed. Phase 2 Data Showed Efficacy VX-548 was tested in patients with acute pain following bunionectomy (surgery to remove a bunion on the foot) and in patients who had abdominoplasty surgery (tummy tuck). These studies allow Vertex to prove efficacy, but the FDA label will likely be broader based on precedent. The Sum of the Pain Intensity Difference over the first 48 hours of treatment (SPID48) was the endpoint used to evaluate efficacy in the phase 2 studies. A higher number on this scale indicates a greater reduction in pain intensity. The phase 2 trials which enrolled 274 and 303 patients respectively, who underwent bunionectomy or abdominoplasty, met the primary endpoints. In both trials, high dose VX-548 was more effective than acetaminophen and hydrocodone, which is sold as Vicodin. (Vicodin is a combination of Tylenol and an opioid.) One facet of the data which was concerning was that, in the bunionectomy study, there was not a clear dose response and mid dose VX-548 performed worse than the low dose, placebo and the opioid reference arm. The drug was well-tolerated, and the majority of adverse events were mild or moderate with no SAEs reported that were related to treatment. Bunionectomy (Bunion Surgery) Placebo n=59 High dose VX-548 n=60 Mid-dose VX-548 n=62 Low dose VX-548 n=33 Hydrocodone Acetaminophen n=60 Mean SPID 48 101 137.8 86.9 112.9 115.6 Difference 36.8 -14.1 11.9 14.7 Abdominoplasty (Tummy Tuck Surgery) Placebo n=77 High dose VX-548 n=76 Mid dose VX-548 n=74 Hydrocodone Acetaminophen Mean SPID 48 72.7 110.5 95.1 85.2 Difference 37.8 22.4 12.5 VX-548 in acute pain is advancing to pivotal development with studies enrolling in 4Q22. The phase 3 program is essentially an identical trial design to phase 2 - Two randomized, double-blind, placebo-controlled studies evaluating the efficacy and safety of VX-548 for moderate to severe acute pain following bunionectomy or abdominoplasty surgery. While not yet enrolling, both studies will also include a hydrocodone bitartrate/acetaminophen treatment arm to assess how VX-548 compares to standard of care opioids. An additional single-arm study is planned which will evaluate the safety and effectiveness of VX-548 for up to 14 days in other types of moderate to severe acute pain. These studies are designed to support a broad moderate-to-severe acute pain label. FDA guidance suggests labelling may include statements regarding reducing opioid dosage and duration of use. In Science, John Wood a neurobiologist who has studied pain pathways such as Nav1.8 at University College London commented on the results: "This is a major advance in the effort to supersede opioids," "These results are terrific, and the side effect profile is very good."
|VRTX||US Biotechs||US Market|
Return vs Industry: VRTX exceeded the US Biotechs industry which returned -25.6% over the past year.
Return vs Market: VRTX exceeded the US Market which returned -23.2% over the past year.
|VRTX Average Weekly Movement||4.0%|
|Biotechs Industry Average Movement||11.1%|
|Market Average Movement||6.9%|
|10% most volatile stocks in US Market||15.6%|
|10% least volatile stocks in US Market||2.8%|
Stable Share Price: VRTX is less volatile than 75% of US stocks over the past 3 months, typically moving +/- 4% a week.
Volatility Over Time: VRTX's weekly volatility (4%) has been stable over the past year.
About the Company
Vertex Pharmaceuticals Incorporated, a biotechnology company, engages in developing and commercializing therapies for treating cystic fibrosis. The company markets SYMDEKO/SYMKEVI, ORKAMBI, and KALYDECO to treat patients with cystic fibrosis who have specific mutations in their cystic fibrosis transmembrane conductance regulator gene; and TRIKAFTA for the treatment of patients with CF 6 years of age or older who have at least one F508del mutation. Its pipeline includes VX-864 for the treatment of AAT deficiency, which is in Phase 2 clinical trial; VX-147 for the treatment of APOL1-mediated focal segmental glomerulosclerosis, or FSGS, and other serious kidney diseases which is in Phase 2 clinical trial; VX- 880, treatment for Type 1 Diabetes which is in Phase 1/2 clinical trial; VX-548, a NaV1.8 inhibitor for treatments of acute, neuropathic, musculoskeletal pain which is in Phase 2 clinical trial; and CTX001 for the treatment severe SCD and TDT which is in Phase 3 clinical trial.
Vertex Pharmaceuticals Incorporated Fundamentals Summary
|VRTX fundamental statistics|
Is VRTX overvalued?See Fair Value and valuation analysis
Earnings & Revenue
|VRTX income statement (TTM)|
|Cost of Revenue||US$4.33b|
Last Reported Earnings
Jun 30, 2022
Next Earnings Date
|Earnings per share (EPS)||12.46|
|Net Profit Margin||38.26%|
How did VRTX perform over the long term?See historical performance and comparison