KORU Medical Systems Inc (KRMD) ニュース

KRMD under $2

Someone loaded this just now

KRMD receives US FDA 510(k) approval for the Freedom60 Infusion System. Press release is imminent.
This is a low-volume trading stock so please be careful. In addition earnings release scheduled for after-market on Wednesday.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K231918


Device Classification Name pump, infusion
510(k) Number K231918
Device Name Freedom60 Infusion Pump; High-Flo Subcutaneous Needle Sets; Precision Flow Rate Tubing; High-Flo Super26 Subcutaneous Needle Sets; Freedom60 Pre-Filled Syringe Adapter
Applicant
Koru Medical Systems
100 Corporate Dr
Mahwah, NJ 07430

Today KRMD released positive earnings. Look for analysts raising stock price targets

https://www.korumedical.com/investors/news-events/press-releases/detail/127/koru-medical-systems-announces-2022-q4-and-full-year

Is it smelling better now?
https://www.korumedical.com/investors/news-events/press-releases/detail/127/koru-medical-systems-announces-2022-q4-and-full-year

.KORU Medical Systems Announces 2022 Q4 and Full Year Financial Results, Accelerating to 19% Revenue Growth in 2022

Recent Highlights:

Fourth quarter net revenue growth of 13% to $7.3 million, marking the fifth consecutive quarter of double-digit growth, and full year net revenue growth of 19% to $27.9 million

Novel Therapies business finished the year with 14 total collaborations to date – growing pre-commercial revenue from $0.5 million in 2021 to $2.5 million for full year 2022

11% Core business growth (U.S. and International) for the year driven by overall SCIg market growth and market share gains through prefilled syringe adoptions

Improved cash position to $17.4 million ending the fourth quarter via strong working capital management

2023 net revenues expected to be between $32.5 and $33.5 million, representing growth in the range of 17-20%

KORU Medical Systems Announces Novel Therapy Collaboration for Three Indications with Kira Pharmaceuticals
November 08 2022 - 07:01AM

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.

Kira will utilize KORU Medical’s Freedom System for Phase II studies of Kira’s lead program, KP-104, an innovative, first-in-class bifunctional complement inhibitor, in three indications. These diseases, collectively affecting over 150,000 patients in the United States and estimated hundreds of thousands more globally, consist of nephrology conditions IgA Neuropathy (IgAN) and Complement 3 Glomerulopathy (C3G) and hematology condition Thrombotic Microangiopathy secondary to Systemic Lupus Erythematosus (SLE-TMA). The expanded Kira partnership reflects the previously announced collaboration with an unnamed partner for a single hematology indication.

“We selected KORU Medical based on their track record of helping patients receive high-value therapeutics subcutaneously in the comfort of their home,” said Chaomei He, Kira’s Head of Chemistry, Manufacturing, and Controls (CMC). “The Freedom System’s ease of use, global regulatory approvals, experience with tens of thousands of patients, and ability to rapidly enter the clinic gave us confidence that KORU was the right partner for our KP-104 program.”

“We are privileged to work with Kira and help them achieve their mission of helping patients living with complement-mediated disease by providing treatment at home,” said Linda Tharby, KORU Medical’s President and CEO. “The expansion of our work with Kira and progression into Phase II studies is another important milestone in our strategy to grow our novel therapies pipeline in multiple therapeutic areas.”

KORU Medical Systems Announces Novel Therapy Collaboration for Three Indications with Kira Pharmaceuticals[color=red][/color]
November 08 2022 - 07:01AM

KORU Medical Systems, Inc. (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use subcutaneous infusion solutions, today announced the progression of its agreement with Kira Pharmaceuticals, including expansion into three important additional indications.

Kira will utilize KORU Medical’s Freedom System for Phase II studies of Kira’s lead program, KP-104, an innovative, first-in-class bifunctional complement inhibitor, in three indications. These diseases, collectively affecting over 150,000 patients in the United States and estimated hundreds of thousands more globally, consist of nephrology conditions IgA Neuropathy (IgAN) and Complement 3 Glomerulopathy (C3G) and hematology condition Thrombotic Microangiopathy secondary to Systemic Lupus Erythematosus (SLE-TMA). The expanded Kira partnership reflects the previously announced collaboration with an unnamed partner for a single hematology indication.

“We selected KORU Medical based on their track record of helping patients receive high-value therapeutics subcutaneously in the comfort of their home,” said Chaomei He, Kira’s Head of Chemistry, Manufacturing, and Controls (CMC). “The Freedom System’s ease of use, global regulatory approvals, experience with tens of thousands of patients, and ability to rapidly enter the clinic gave us confidence that KORU was the right partner for our KP-104 program.”

“We are privileged to work with Kira and help them achieve their mission of helping patients living with complement-mediated disease by providing treatment at home,” said Linda Tharby, KORU Medical’s President and CEO. “The expansion of our work with Kira and progression into Phase II studies is another important milestone in our strategy to grow our novel therapies pipeline in multiple therapeutic areas.”

KRMD is a good defensive play for this market.

Immunoglobulin therapies to patients with chronic illnesses such as Primary Immunodeficiencies (PIDD) and Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is not an option. Its a necessity!

Subcutaneous infusion devices are the preferred way to deliver life-saving immunoglobulin therapies. Why? Cost. Its cheaper. Convenience. It can be administered by the patient when it works for them and their schedule. Medication levels are more even. The patients do not suffer from medication spikes, a side effect, that sometimes follows I.V. infusions.

KORU Medical Prices Public Offering of Common Stock
June 19, 2020 07:50 AM Eastern Daylight Time
CHESTER, NY--(BUSINESS WIRE)--Repro Med Systems, Inc. d/b/a KORU Medical Systems (Nasdaq: KRMD) (“KORU Medical”) today announced the pricing of its previously announced underwritten public offering of 3,125,000 shares of its common stock at a public offering price of $8.00 per share. The gross proceeds to KORU Medical before deducting the underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $25 million. In connection with the offering, KORU Medical has granted the underwriters a 30-day option to purchase up to an additional 468,750 shares at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about June 23, 2020, subject to customary closing condition

LETS KEEP THINGS IN PERSPECTIVE, TWO YEARS AGO THE SHARE PRICE WASS OVER $8.

https://www.businesswire.com/news/home/20200619005195/en/KORU-Medical-Prices-Public-Offering-of-Common-Stock

WHERE IS THE VALUE CREATION
Linda Tharby has been at the helm since April 2021. At that time the share price was about $3.5<>$3.75. The has been one public investor presentation 12/9/21 called ironically "Vision 2026 -next phase value creation".

I agree.

KRMD is very much Linda Tharby's company. She has been bringing her people into the company. So Goodbye Karen

This one is not passing the stink test..............
BRIEF-Repro Med Systems Inc - Karen Fisher, CFO, Will Resign Her Employment Effective As Of June 30, 2022
BY Reuters
— 6:07 PM ET 05/18/2022
May 18 (Reuters) - Repro Med Systems Inc (KRMD):
* REPRO MED SYSTEMS INC (KRMD) - KAREN FISHER, CFO, WILL RESIGN HER EMPLOYMENT EFFECTIVE AS OF JUNE 30, 2022
* REPRO MED SYSTEMS INC (KRMD) - COMPANY HAS ENGAGED A SPECIALIZED FIRM TO CONDUCT A SEARCH OF POTENTIAL CANDIDATES TO REPLACE FISHER
* REPRO MED SYSTEMS INC (KRMD) - IN INTERIM, TOM ADAMS, WILL SERVE AS INTERIM CHIEF FINANCIAL OFFICER OF COMPANY EFFECTIVE JULY 1, 2022

MMMM, let me think?
Who were the presenters doing the presentation that was left on the company's website?
MMMM let me look?
Oh ya, of course, Linda Tharby was one of the presenters.

MMMM, interesting?
Who was the CEO doing the previous presentations??
MMMM, let me think???
OH it was that other guy, the one that left just about the time the lawsuits were filed. t

UNDERSTAND NOW

Why did Koru remove all their presentations (except for one) from their website's Investors section?

All the presentations from the last few years are no longer there...

The stock price drifts down while the market shoots up. Disconcerting.
I do not see the management making an effort to support the stock. No buyback. (stock price is down % from last offering @ $8/share!) No insider buying(or selling). No meeting with the investment community.

In 2021 the stock took a 47% shaving. 2022 has to be better.

It was pointed out to me that the FDA posted the approval yesterday on thier website. APPRECIATED

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K200176

NOW WE KNOW THE REASON FOR THE BIG JUMP THE OTHER DAY. SOME PEOPLE HAVE ACCESS TO INFORMATION BEFORE THE PUBLICK IS TOLD. THE GAME IS RIGGED AGAINST THE SMALL RETAIL INVESTOR!!
sometimes ya gotta laugh

Adding Xembify®, manufactured by Grifols is huge

Grifols, S.A. is a Spanish multinational pharmaceutical and chemical manufacturer. Principally a producer of blood plasma-based products, a field in which it is the European leader and largest worldwide, the company also supplies devices, instruments, and reagents for clinical testing laboratories

KORU Medical Systems Receives FDA 510(k) Clearance for the Use of the FREEDOM60® with Two Additional SCIg Drugs

https://www.korumedical.com/investors/news-events/press-releases/detail/106/koru-medical-systems-receives-fda-510k-clearance-for-the

CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) (“KORU Medical” or the “Company”), a leading medical technology company focused on the development of innovative and easy-to-use home infusion solutions, today announced FDA 510(k) clearance that expands on-label use of the FREEDOM60 Infusion System to two additional subcutaneous Ig (SCIg) medications, Cutaquig®, manufactured by Octapharma, and Xembify®, manufactured by Grifols.

“We are excited to announce another milestone for KORU Medical as we seek to further improve patients’ quality of life through the development and delivery of high-quality therapeutic drug delivery in the home. Having the FREEDOM60 Infusion System cleared for use with Xembify and Cutaquig allows patients and providers additional options for life enhancing subcutaneous immunoglobulin therapy treatment in the home with a system that has broad patient and healthcare worker adoption,” said Linda Tharby, President and CEO. “KORU Medical’s Freedom Infusion System is specifically cleared for use with more SCIg drugs than any other system. Adding Xembify and Cutaquig to our label, in addition to our recent FDA 510(k) clearance for use of Hizentra® prefilled syringes with the FreedomEdge®, extends KORU Medical’s leadership position in the growing SCIg market.”

my interpretation is someone sees value 3/6 months down the line and is establishing a position prior to the end of the year.

KRMD SHARES HALTED ON CIRCUIT BREAKER

60k share buy hit at 11:03

stock hit $3.43 before investors started selling the news.

Someone feels this is a good price?

Interesting

A small stock repurchasing at these prices would be an intelligent use of capital. What do you think?

Piper Sandler/KRMD: Exciting Outlook During Investor Meeting, Now It’s Time to Deliver

Piper Sandler also participated in the underwriting. They maintained a neutral rating.

i am aware of the relationship between KRMD and CW. Also Alex has been overly optimistic. I think the stock is oversold in the $3.1 area and have been buying.

I would be wary of CH's PT. They conducted the equity raise t $8, so there is definitely a moral hazard there...

Alex Nowak, a senior analyst from, Craig-Hallum reiterated a BUY rating with a $7 price target.

i listened to the call. The drivers for growth remain the same. Subg is cheaper, more convenient and has less patient adverse reactions because medication levels remain more even in the blood level. The company continues to work with/partner with drug companies in a mutually beneficial symbiotic relationship.

Bottom line is a question of execution. And time will tell.

The guidance given seems conservative. I believe KORU medical has a quality, dedicated professional team. I expect some analyst will release upgrade evaluations with higher stock target price.

It should be. This segment has been small since the introduction Vivaglobin in 2006. After 15 years, they claim to be the market leader with only $20 million in sales? How could they project $50million? A little research here tells you the SCIG segment is still small, perhaps under $40 million. It holds good prospects, but IVIG still scales SCIG by an 80% market share for PIDD.

The new CEO is more measured. She will manage expectation. And will not bite off more then she can chew.

Let's see what they come up with. Will certainly be interesting...

LOL
a new matrix, more realistic matrix coming out tomorrow.

Dug this up from the 2018 10K. Seems like the company is great when it comes to talking with investors but terrible when it comes to execution. 9 months ended September revenues at $14mm, margins at 58%, and negative growth:


OUR STRATEGY
In January 2019, the Board of Directors approved our strategic plan to become the preferred drug delivery partner for specific infusion therapies in select markets.

The financial goals for our strategic plan through 2022 are:
• $50 million net revenue run rate
• 70%+ gross margins, and
• 20%+ annual organic revenue growth

We are committed to delivering simple, effective, drug delivery systems to the home health care environment. We believe our Freedom Infusion Systems using DynEqTM technology is superbly positioned for Immunoglobulin therapy and we plan to build on that platform. We plan to drive revenue by supporting the accelerating adoption of Hizentra®, Cuvitru® and other formulations for immunoglobulin therapy and participating in the migration of other therapeutics into the home health marketplace globally. We expect to leverage our specialty pharmacy customer base by bringing additional products and services to our channel.

New to this board. Reviewing their record, i do not see how this year's sequential growth is such a big deal, when their sales eroded by 15% from 2020 same YTD period. They claim accounting designation for novel sales to Apellis inflated 2020 numbers. But sales is sales - and when you are down you are down. For being the market leader, and touting Ig / pharma relationships, their sequential growth this year in minimal.

Earnings


https://www.korumedical.com/investors/news-events/press-releases/detail/104/koru-medical-systems-announces-2021-third-quarter-financial

My first take is the new CEO is executing.

KORU Medical’s Freedom Edge becomes the only device specifically cleared for delivery of subcutaneous Ig prefilled syringe

CHESTER, N.Y.--(BUSINESS WIRE)-- Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ: KRMD) ("KORU Medical" or the "Company"), a leading medical technology company focused on the development, manufacturing, and commercialization of innovative and easy-to-use specialty infusion solutions that improve quality of life for patients, today announced 510k clearance for use of the KORU Medical FreedomEdge® infusion pump to deliver Hizentra® [immune globulin subcutaneous (human) 20% liquid] 20 mL prefilled syringes. Hizentra® is the most prescribed subcutaneous Ig product and the first to be available in a prefilled syringe format.

“Our patients who use prefilled syringes tell us that their infusions are significantly easier. With the FreedomEdge® they simply place syringes in the pump and infuse, avoiding the drug transfer process that many patients find difficult and stressful. We’re excited to see KORU Medical’s commitment to improve patient satisfaction by getting this important FDA clearance,” said Amy Ehlers, Senior Director of Clinical Programs at NuFactor, a leading specialty infusion pharmacy.

https://www.korumedical.com/investors/news-events/press-releases/detail/103/koru-medical-announces-fda-clearance-for-delivery-of

There have been a series of PRs from the company leading up to earnings.

My interpretation is that the new CEO, Linda Tharby, is comfortable enough with the story, and has a vision for the future, that she feels the time is right for the management team to start talking with investors.

We will find out what the numbers say on Wednesday.

KORU Medical Systems to Participate in Two Upcoming Conferences

https://www.korumedical.com/investors/news-events/press-releases/detail/102/koru-medical-systems-to-participate-in-two-upcoming

KORU Medical's management is scheduled to present at the following;

Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum on Thursday, November 18, 2021 at 11:00 AM EST
The 33rd Annual Piper Sandler Healthcare Conference 1x1 investor meetings will take place Wednesday, December 1, 2021. Management will also participate in a pre-recorded fireside chat, which will be available beginning Monday, November 22nd at 10:00 AM EST
Interested parties can access the live and archived webcast on the News/Events page of the Investors section of KORU Medical’s website at www.korumedical.com. The archived webcast will be available for six months.

KORU Medical Announces Collaboration With Gilero to Accelerate Innovation

https://www.korumedical.com/investors/news-events/press-releases/detail/101/koru-medical-announces-collaboration-with-gilero-to

its collaboration with Gilero, a medical device design and manufacturing company. Gilero offers unparalleled engineering and manufacturing solutions and has been a trusted partner for medical and drug delivery device companies for 20 years. The collaboration is part of KORU Medical’s strategic focus on innovation as the Company expands and evolves its at-home infusion products and portfolio.

bid is sitting at $2.40.

I see the price drop forcing Horton Capital management being pressured to sell.

Broke $2.70 support. Fib retracement showing $2.40 is next, $2.10 after that. Have seen very low liquidity lately although there was high volume today. Will have to see if more funds continue to pull out amid underperformance; only a bad feedback loop from here.

Congratulations to krmd management for optimizing shareholder value!!!

New intra day low of $2.53.

Keep up the great work.

correction - there was an intraday low of $2.70 in 4/21

$2.85
Absolutely incredible!

Stock is at the same levels is was at in July, 2019. The stock has lost over 3/4 of its value from an all time high of $12.80 reached in April of 2020. WOW!!!

This is against aa background of a bull market.

I do not see delisting as an immediate concern.

There is uncertainty around the lawsuits.

As the stock sinks the pressure increases on Horton capital management? Will there be a secondary offering?

Companies are having trouble finding and keeping quality help. Is this an issue for KORU medical, or its outsource manufacturer? You can not sell what you can not make. I see many stores reducing hours and/or service due to help shortages.

Pressure on the health care sector will reduce the number of new scripts for pumps?

The company continues to bleed money and is unable to plug the leak.

I would not be surprised to see key members of management or the board jumping ship?

The expected second half improvements was based on the assumption of declining covid cases. The delta variant, and the large number of unvaccinated people put a kink in this assumption.

Now for the good new?

Company is trading like it was a few years ago... low volume, mediocre liquidity, and abrupt price changes. Anyone concerned about a delisting?

shocking

100K shares sold at closing on a Friday.
Another 65K sold between 3:50 and 4:00.
Monday might be very ugly?

Horton Capital management bought 35K shares on 8/16 and 8/17 at a price of $3.40/3.41.

The most important votes are with the pocket.

2nd quarter earnings

https://finance.yahoo.com/news/koru-medical-systems-announces-2021-200100306.html

Second Quarter 2021 Summary:

Solid net revenue of $5.5 million; positive sequential quarterly growth

Gross margin of 58.1%

Net loss of $1.1 million

"We are pleased with our performance and sequential revenue growth in the second quarter and look forward to continuing to build growth and momentum in the second half of 2021. We are beginning to see a rebound in growth in the subcutaneous immunoglobulin market, and we are well positioned to remain the category leader,"