Frankestin
2週前
“DefenCath continues to exceed expectations despite pending TDAPA expiration.”
Real-world clinical practice often extends beyond reimbursement mechanics. Once physicians observe improved outcomes in patients already benefiting from therapy, discontinuation becomes a clinical decision, not merely a reimbursement one.
If post-TDAPA utilization stabilizes even in the $80-85M per quarter range, the recently raised 2026 guidance of $325-345M in revenue and $115/135M in adjusted EBITDA could prove conservative.
Additional upside may also come from label expansion, including the ongoing Phase 3 study in TPN patients, currently trending toward completion in 2028, although efforts are underway to improve the enrollment trajectory.
rosemountbomber
2週前
That, of course is the big question. I am not well enough versed as to whether there are examples where a great drug loses TDAPA coverage and still manages to do well. It is interesting that the market is severely discounting the TDAPA expiration, whereas a number of analysts (of course we know analysts sometimes put targets for other reasons) do not think that the TDAPA expiration will hurt revenues as much as the market projects. I am concerned though that even if revenues surprise in 2H2026 and 2027 that the stock price will not rebound until after the market sees those better than projected revenues. Anyway this is what AI has to say about it:
Yes, the market has heavily discounted the TDAPA termination, which largely explains why CorMedix stock (CRMD) trades at a depressed valuation despite stellar operational growth. The stock collapsed 35.9% year-to-date from
$12.16 down to $??.????, reflecting aggressive de-risking by institutional investors ahead of the June 30, 2026 cliff.
While the business is performing exceptionally well on paper, a deep division has emerged between conservative market pricing and bullish Wall Street analysts.
The Valuation Disconnect (Why the Stock is Compressed)
The market is pricing CorMedix like a "value trap" due to the uncertainty surrounding the post-TDAPA bundled payment system.
AOL.com
+1
Abnormally Low Multiple: CRMD currently trades at an incredibly compressed trailing Price-to-Earnings (P/E) ratio of 3.7x. For a commercial-stage biopharma company growing revenue at this pace, such a low multiple typically signals that the market views current earnings as a temporary "peak" that will normalize downward.
Extreme Revenue Decline Priced In: Bearish market models are factoring in a massive sequential revenue decline for DefenCath in H2 2026. Some extreme short-term projections estimate up to an 80% sequential drop in net selling price per unit during the Q3 and Q4 transition window as price erosion takes hold.
Seeking Alpha
+2
Wall Street Analysts Disagree with the Discount
While the broader market has sold off the stock to price in a worst-case reimbursement scenario, Wall Street equities analysts view this discount as heavily overdone.
Aggressive Price Targets: The consensus analyst rating remains a Moderate Buy with a consensus 12-month price target of
$????.????. This represents a 91.2% predicted upside from the current trading price.
RBC Capital Leading the Bulls: Major institutional analysts, such as Leonid Timashev at Royal Bank of Canada, recently raised their price target from
$13.00 to $????.???? following the Q1 earnings call, completely looking past the TDAPA noise.
Management's Pushback: A Temporary Trough, Not a Collapse
CorMedix leadership explicitly outlined to investors that the market's panic over H2 2026 ignores the structural reality of how CMS add-on frameworks function.
The 2026 "Trough" Narrative: Management defines late 2026 as a temporary financial trough. They are intentionally sacrificing short-term price margins to aggressively protect and grow patient utilization volumes.
The 2027 Stable Baseline: The strategic goal is to enter 2027 with massive market share. By 2027, CMS is expected to establish a highly stable, predictable post-TDAPA add-on payment structure.
No Dilution Risk: CorMedix is well-positioned to ride out this transition period because it holds
$?????? million in cash on its balance sheet. This cash runway allows them to fully fund their pipeline—including the upcoming REZZAYO sNDA submission and ongoing clinical trials—without needing to dilute shareholders at these lower stock prices
iHub News
3週前
CorMedix Shares Jump After Revenue Beat and Higher Full-Year GuidanceMay 14, 2026 10:06 AM
IH Market News CorMedix Therapeutics (NASDAQ:CRMD) shares surged 8% in premarket trading Thursday after the company raised its full-year outlook despite reporting quarterly earnings slightly below analyst expectations. Revenue Surges More Than 200% Year-on-Year CorMedix posted adjusted earnings per share of $0.43 for the first quarter, narrowly missing analyst expectations of $0.45 by $0.02.Revenue reached $127.4 million, comfortably ahead of the consensus estimate of $105.02 million.The result represented a 226% increase compared with $39.1 million in the same quarter last year. Company Raises Full-Year Forecasts CorMedix increased its full-year 2026 revenue guidance to a range of $325 million to $345 million.The midpoint of the updated forecast, at $335 million, exceeded analyst expectations of $308.2 million.The company also lifted its adjusted EBITDA guidance for the year to between $115 million and $135 million. DefenCath Continues to Drive Growth Sales of DefenCath contributed $97.5 million in net revenue during the quarter.CorMedix said the increase was supported by stronger utilization among outpatient dialysis customers, as well as a one-time favorable adjustment of $9.0 million related to sales allowances.Revenue from the recently acquired Melinta portfolio totaled $29.9 million during the period.The company reported net income of $38.6 million and adjusted EBITDA of $70.0 million for the quarter. CEO Says Business Momentum Remains Strong Chairman and chief executive Joseph Todisco said the company entered 2026 with strong operational momentum.“CorMedix has entered 2026 with strong momentum across all areas of our business,” Todisco said. “DefenCath continues to exceed expectations despite pending TDAPA expiration and demonstrates strong underlying utilization demand.” Positive Clinical Trial Results Support Expansion Plans The company also announced positive Phase III topline results from the ReSPECT clinical trial evaluating REZZAYO for the prevention of invasive fungal diseases.CorMedix said it plans to submit a supplemental New Drug Application during the second half of 2026, targeting a potential commercial launch for the expanded indication in 2027. Expenses Increase Following Melinta Acquisition Cash and short-term investments totaled $178.1 million as of March 31, 2026.Total operating expenses rose 139% year-on-year to $41.5 million, primarily due to costs associated with the Melinta acquisition.CorMedix stock price Original: CorMedix Shares Jump After Revenue Beat and Higher Full-Year Guidance
ItsMyOption
3月前
I based that on other positive moves CRMD made. I feel CRMD hit bottom today at $6.13 and should move up nicely into and beyond 2026 especially with the accusation of the Melinta portfolio, which added to cost reported in 2025
Recent Corporate Highlights:
? CorMedix announces $128.6 million of net revenue for the fourth quarter of 2025, largely driven by continued utilization of DefenCath by its outpatient dialysis customers. DefenCath sales contributed $91.2 million of net revenue in the quarter.
? For the full-year 2025, CorMedix achieved total revenue of $311.7 million and pro forma total revenue of $401.3 million.(1)
? In the fourth quarter of 2025, the Company recognized Net Income of $14.0 million and adjusted EBITDA of $77.2 million.(2) Basic and Fully Diluted EPS were $0.18 and $0.16 per share, respectively.
? CorMedix reiterates previously established guidance for 2026, including net revenue of between $300 and $320 million and adjusted EBITDA of between $100 and $125 million.
? CorMedix announced in early February that its Board of Directors approved a share repurchase program, which authorizes the Company to repurchase up to $75 million of the Company’s outstanding common stock.
? As highlighted during the Company’s recent Analyst Day, CorMedix expects clinical data from the Phase 3 ReSPECT study of REZZAYO® (rezafungin for injection) in the prophylaxis of invasive fungal infections in adult patients undergoing allogeneic blood and marrow transplant in Q2 2026. In addition, the ongoing Phase 3 study of taurolidine/heparin catheter lock solution in TPN patients continues to enroll patients with targeted completion in the first half of 2027.
? Cash and short-term investments, excluding restricted cash, at December 31, 2025 amounted to $148.5 million.
For the year ended December 31, 2025, CorMedix recorded $311.7 million in total revenue, including $258.8 million in net sales of DefenCath and $52.9 million in net revenue from the legacy Melinta portfolio. Pro forma 2025 revenue, which reflects full-year revenue from the Melinta portfolio in addition to full-year net sales of DefenCath, was $401.3 million. The Company reported net income of $163.0 million, or $2.04 per diluted share, compared with a net loss of $17.9 million, or ($0.30) per share, in 2024. Net income was driven primarily by an increase in sales of DefenCath, and, to a lesser extent, net revenue from the acquisition of Melinta, partially offset by higher operating expenses.
Operating expenses during the year ended December 31, 2025 totaled $125.6 million compared with $62.6 million for 2024, an increase of $63.0 million, or 101%. The increase over the prior year was driven primarily by the acquisition of Melinta, including the contribution of operating expenses from Melinta’s business for the period from August 29, 2025 through the end of the year as well as transaction, integration and severance costs. Other drivers of the year-over-year increase include stock-based compensation and investment in research and development programs associated with expanded indications for DefenCath, including the Phase III clinical study for prevention of CLABSI in TPN.
Frankestin
3月前
Solid results for a company with a surprisingly small market cap.
CorMedix reported a very strong Q4 and full-year 2025, driven primarily by continued uptake of DefenCath.
Revenue growth driven by DefenCath: Q4 net revenue reached $128.6 million, including $91.2 million from DefenCath and $37.4 million from the Melinta portfolio.
For FY 2025, total revenue was $311.7 million, with $258.8 million coming from DefenCath, confirming the product as a strong commercial driver.
Highly profitable operations: Despite increased operating expenses, the company generated Q4 net income of $14.0 million (EPS $0.16) and adjusted EBITDA of $77.2 million.
For the full year, net income reached $163.0 million (EPS $2.04), a remarkable level of profitability for a company still early in its commercial ramp.
Strong balance sheet: CorMedix ended 2025 with $148.5 million in cash and short-term investments, providing financial flexibility to support commercialization and pipeline development.
Shareholder returns already starting: The board approved a share repurchase program of up to $75 million, signaling management confidence in the company’s valuation and cash generation.
Pipeline catalysts ahead: Additional value could come from ongoing clinical programs, including:
• Phase 3 ReSPECT data for REZZAYO prophylaxis expected in Q2 2026
• Continued enrollment in the Phase 3 taurolidine/heparin catheter lock study in TPN patients, targeting completion in H1 2027
Stable outlook for 2026: The company reiterated 2026 revenue guidance of $300–320 million and adjusted EBITDA of $100–125 million, indicating expectations for sustained profitability.
Bottom line: With over $300 million in annual revenue, strong profitability, meaningful cash reserves, and a share buyback program, it is notable that CorMedix currently trades at a market capitalization of only about $570 million—a valuation that appears modest relative to its earnings power and growth potential.
timberwolf7
11月前
Some changes taking place for CRMD since I sold:
-recently announced good earnings, helped liff the share price
-then just about a week ago, announced a new major customer signed o
spiked the share price up above $17, justified mind you
-share price was just selling off after this latest PR when
they just announced a 6 Mil + share offering @ 12.66 or so per share
to raise $85 Million.
This hit the share price hard, drove it to less than $12.60 in a $2.45 DROP
this morn..
So, decided given the revenue growth trend, earnings growth, new customer
and the hit to the share price, to take advantage of the hit this morn.
New positions at sub $12.6.. Only looking for $15, but also once the share
price starts to smooth out, selling pressure stops? May start selling covered
calls...
timberwolf7
1年前
A pretty good investment call with Needham.. Worth listening to from April 8th.
My take away is that I expected the end users would be actively pursuing the use of
CRMDs development cause it can save lives, save money if a CBRSI is prevented.
But it appears the uptick is slower than I was expecting and might be due to the end
users wondering if it really does what they say it can do. IE, a bit of caution involved.
CEO says that he expects as some adopt and the word gets out its 'working' as advertised,
it will lead to others (reluctance/hesitancy) to adopt as well.
Anyways, given the potential growth trajectory, this is looking like a much longer hold than
I was planning on doing (you ever get one that you take profits on too early?? and miss out
on a lot more if you had just been patient to let it play out??)
https://wsw.com/webcast/needham146/crmd/2238926
Frankestin
1年前
1. Outbreaks Linked to Dialysis and Catheters
Dialysis:
A 2022 CDC report documented a C. auris outbreak in a Texas dialysis center, where infections spread among patients using central venous catheters. The primary cause was traced to failure to follow sterilization protocols.
Dialysis patients are high-risk due to frequent use of invasive devices (e.g., catheters) and weakened immune systems from chronic kidney disease.
Catheters:
A 2020 study in Clinical Infectious Diseases found that 40% of U.S. C. auris infections were linked to invasive devices like central venous catheters or urinary devices.
A deadly 2019 outbreak in a Brooklyn, NY, ICU involved C. auris transmission via catheters and ventilators, resulting in 5 deaths.
2. Documented Legal Disputes
Illinois (2018): A patient died after contracting C. auris via a contaminated catheter. The family sued the clinic for negligent equipment hygiene.
New Jersey (2020): A long-term care facility faced a lawsuit after a dialysis patient developed C. auris from a non-sterile catheter. The case settled out of court.
California (2021): A healthcare facility confronted a class-action lawsuit over an outbreak tied to unsafe reuse of medical devices, including dialysis catheters.
3. Regulatory Actions
Florida (2021): A dialysis center was fined by CMS for violating infection-control standards after a C. auris outbreak.
The CDC issued updated guidelines for catheter management in high-risk patients, referencing failures in dialysis facilities.
Frankestin
1年前
These lawyers should file class actions against hospitals!
Joe raises the price, you exploit the fears of those who have to decide the purchase!
If a patient develops a severe infection or dies, and it is discovered that a better solution existed but was not adopted, a lawsuit is not only possible but likely. In the United States, civil justice is quick to hold accountable those who fail to provide the best possible care, and settlements can be enormous.
In the U.S., every healthcare provider is well aware that effective tools exist to prevent infections. Given this awareness, it should be a patient’s right—and a healthcare system’s duty—to ensure access to the best available protection.
In the U.S., the concept of standard of care is crucial: if it is proven that a facility provided care below the generally accepted medical standards, it opens the door to a lawsuit.
Costs and damages for the patient ? A severe infection can lead to:
Longer hospital stays
Permanent damage
Loss of income
Additional medical expenses
Death
If a product (such as DefenCath) exists that reduces the risk of infections but was not used, a lawyer could argue that the hospital put the patient’s life at risk for financial reasons.
Frankestin
1年前
Candida auris is an emerging fungus that represents a serious global public health threat due to its resistance to multiple antifungal drugs and its ability to cause outbreaks in healthcare settings. First identified in Japan in 2009, it has rapidly spread internationally, with cases reported in numerous countries, including Italy.
The market for treatments targeting Candida auris infections is growing, reflecting the increasing incidence of infections and the need for effective therapies. According to a report, the global market for Candida auris infection treatment was valued at $1.01 billion in 2023 and is projected to reach $2.0 billion by 2032. This growth is attributed to the rising awareness of Candida auris infections and the increasing number of cases in healthcare settings, which drive demand for more effective diagnostic and therapeutic solutions.
— Market Research Future
Furthermore, the broader candidiasis therapeutics market, which includes treatments for various Candida infections, was valued at $4.5 billion in 2022 and is expected to reach $6.8 billion by 2030, with a compound annual growth rate (CAGR) of 5.5% from 2024 to 2030. This indicates a growing investment in the development of new antifungal agents and innovative therapies to combat Candida infections, including Candida auris.
Frankestin
1年前
Taurolidine was originally developed to prevent infections. Today, it’s showing signs of antitumor activity.
Preclinical studies suggest it could act on MYC-driven tumors — neuroblastoma, lung, ovarian, lymphoma — among the most difficult to treat.
Developing these kinds of therapies is expensive. Very expensive.
But the potential is massive — and not just for investors. It's in everyone’s interest that promising molecules don’t get stuck halfway.
We must give things their proper value: this is good science, but it requires time, capital, and strategic vision.
And CorMedix has that vision. While looking ahead to oncology, it’s already building a cash-generating engine in the present.
DefenCath, a non-antibiotic solution based on taurolidine and heparin, is already FDA-approved for preventing catheter-related infections in dialysis patients.
The numbers?
$43 million in 2024 revenue, EBITDA > $12 million
Zero debt, $52 million cash
Price: $249 per vial
Contracts in place with 4 of the 5 largest U.S. dialysis providers
CMS reimbursement secured (TDAPA and NTAP)
In short, they’re self-funding.
And they’re expanding DefenCath into TPN, pediatrics, and oncology.
Once economies of scale kick in, this won’t be just a small biotech. It’ll be a case study.
The potential is huge. So is the strategy.
Time will tell who saw it early —
and hopefully, the shorts will cover before it's too late.
timberwolf7
1年前
Should turn out to be a good buy with time.
Had a meeting this morn, just getting free.
But when I saw the premarket, warned someone that it looks
like a classic takedown was in the works for this morn..
Yahoo was still showing a heavy short position, this report
was POSITIVE, new target price is $18 (3/5 if I remember the date right)
and so a thinking the shorts had no choice but to hammer it this morn, scare
new buyers away. But its pretty clear now, the company has turned the corner
and its going to get harder to keep this hidden from the market. So expect to see
the short position slowly closed down while they try to hold the share price down.
Given that, yeah, think a buy now should be good for at least a 50% return, and if
the ones that have been screwing around with the share price ever stop?? Be nice to
see that $18 target price.
disclaimer: temped to sell 1/10th of my TNXP for some more shares but won't till
I see 'life' in CRMDs chart..
timberwolf7
1年前
Going to be interesting to see what it does when it releases its earnings/update.
(doesn't look like they have given a date yet for it) (last time they 'announced' on the 23rd
of Oct, then released on the 30th.. IF they follow that 'pattern'?? Maybe we hear something
this week?? Be nice to keep the chart from losing momentum, rolling over..
For there is still 7 Million shares reportedly SHORTED (over 10% of the outstanding).
Been tracking this number for many months now and it refuses to budge towards 5% for example.
And I can't come up with a good reason WHY it refuses to come down. Or WHY they are holding onto
a heavy short position. Although I suspect its because when things are 'quiet', they can easily hit it
when demand is weak, ak, how it got taken down to $8 for example.. Which they might be getting ready
to do now given the earnings isn't expected till?? (momentum/trend line rolling over, slight negative slope now)
Disclaimer: already sold around 1/2 of my shares on the first run up, but didn't get 'all' of that move..