WEB NEWS Research
KORU Medical Systems (NASDAQ:KRMD) ($2.12; $96.8M market cap), announced Q4 2023 results:
Q4 sales of $7.2 million vs $7.3 million in the prior year; ahead of analyst estimates of $6.9
Q4 Non-GAAP loss per share of $0.02 vs net loss of $0.04 in the prior year; ahead of analyst estimates of a loss of $0.04
Full year sales of $28.5 million vs $27.8 million in the prior year
Full year non GAAP net loss of $0.13 vs a net loss of $0.14
“I am proud of the KORU team for delivering a solid end to 2023, led by performance in our Core business. Entry into multiple geographic markets drove international sales, and in the US, we hit a key milestone with the FDA clearance and launch of the 50mL prefill pump platform, which we anticipate will be a significant growth driver in 2024. Additionally, we saw double-digit growth in our end-user specialty pharmacy sales, reflective of share gains and a growing Ig market,” said Linda Tharby, KORU Medical's President and CEO. “Within our Novel Therapies business, we recently announced collaborations for two late-stage therapies. On the operational side, we increased gross margins, were cash flow positive in the fourth quarter and finished the year with a significantly lower cash burn than the prior year. We are excited by the momentum we are carrying into 2024; we remain focused on the execution of our Vision 2026 strategy, and positioning KORU for growth, profitability and value creation for our customers and shareholders.”
Guidance:
Research
KORU Medical Systems (NASDAQ:KRMD) ($2.19; $99.9M market cap), a home infusion therapy medical device company, announced Q3 2023 results:
Sales of $7.0 million vs $7.7 million in the prior year; below analyst estimates of $7.9
Non-GAAP loss per share of $0.03 vs net loss of $0.03 in the prior year; in line with analyst estimates of a loss of $0.05
“Our third quarter revenues were impacted by our Novel Therapies business due to the timing of collaborations and by our Domestic Core business, which saw lower than anticipated growth in the underlying market. We progressed several initiatives in the quarter aimed at growing our top-line, including expanding our Novel Therapies collaborations, outperforming the U.S. subcutaneous immunoglobulin market, advancing our geographic expansion efforts, and gaining a new 510(k) clearance for a prefilled syringe indication," said Linda Tharby, KORU Medical's President and CEO. "We simultaneously advanced our efforts towards profitability and delivered on our gross margin goals despite revenue headwinds by exercising strategic operational expense discipline in light of our current environment. We are confident we have the right plan in place to capitalize on upcoming catalysts, grow our position in our subcutaneous immunoglobulin business, and expand into the larger addressable Novel Therapies market."
KORU Medical Outlook:
Reducing full year 2023 net revenue guidance to $28.0 - $28.5 million, from prior guidance of $31.0 - $32.5 million.
Reaffirming 2023 gross margin guidance between 58%-60% and a planned 2023 exit between 60%-62%.
Increasing cash balance guidance at year-end 2023 to greater than $10.5 million.
Research
KORU Medical Systems (NASDAQ:KRMD) ($2.37; $109.9M market cap), a home infusion therapy medical device company, announced Q2 2023 results:
Sales of $6.9 million vs $6.5 million in the prior year; below analyst estimates of $7.2
Non-GAAP loss per share of $0.05 vs net loss of $0.06 in the prior year; in line with analyst estimates of a loss of $0.05
"I am pleased with our second quarter progress, as our growth exceeded the overall SCIg market in both the U.S. and Internationally," said Linda Tharby, KORU Medical's President and CEO. "The foundation of our business remains sound, and we are diligently focused on delivering above-market revenue performance, advancing our portfolio with our innovation efforts, and increasing the number of drugs on our Freedom Infusion System. We are excited to welcome Tom Adams as our Chief Financial Officer and look forward to his continued leadership contributions. We remain committed and on track to attain our Vision 2026 strategic goals, and deliver added value to patients, customers and shareholders."
KORU Medical Outlook:
Reducing full year 2023 net revenue guidance to $31.0 - $32.5 million, representing growth in the range of 11%-17% from prior guidance of $32.5 - $33.5 million, representing growth in the range of 17-20%
Reaffirming 2023 gross margin between 58%-60% and a planned 2023 exit between 60%-62%
Research
KORU Medical Systems (NASDAQ:KRMD) ($2.48; $115.0M market cap), a home infusion therapy medical device company, announced preliminary second quarter 2023 results and provided a business outlook for the full year.
Expects Q2 2023 to be $6.9 million representing 6% growth from the prior year but below analyst estimates of $7.5 million
Full year 2023 revenue expected to be between $31 and $32.5 million, representing growth of 11% to 17% from the prior year, high end of guidance is in line with analyst estimates of $32.3. million.
“The Company's guidance for full year 2023 has been updated to reflect a Q2 2023 decline in the U.S. subcutaneous immunoglobulin market, resulting in a change of KORU Medical’s outlook on underlying U.S core market growth assumption from 10% to the mid-single digit range.
I am pleased our U.S. revenue growth significantly exceeded the overall U.S. market in the quarter and we saw continued strength in our international business," said Linda Tharby, KORU Medical's President and CEO. "The foundation of our business remains sound, and we see continued progress this quarter in Novel Therapies collaborations, with a new deal being signed and the early submission of a 510(k) for use on our FREEDOM60® Infusion System with Hizentra® 50 mL prefilled syringes. Given the U.S. SCIg market performance, and the timing of revenues from our Novel Therapies collaborations, we are updating our guidance. We remain diligently focused on delivering above-market revenue performance, advancing our portfolio with our innovation efforts, and increasing the number of drugs on our Freedom Infusion System. We remain committed and on track to attain our Vision 2026 strategic goals, including achieving +$60 million in revenues."
Research
KORU Medical Systems (NASDAQ:KRMD) ($3.79; $171.6M market cap), a home infusion therapy medical device company, announced a development agreement for prefilled syringes with a pharmaceutical manufacturer of subcutaneous immunoglobulin therapy.
“The Freedom Infusion System is the only infusion system approved for prefilled syringes, and we are excited by the opportunity to expand the number of prefilled subcutaneous therapies that are FDA approved for our innovative infusion system.”
These types of arrangements, where KRMD works with pharma companies to integrate KRMD’s solutions into their product offerings, is a big part of the current CEO’s vision to create long term streams of reliable recurring revenue.
The terms of the agreement were not disclosed.
Research
KORU Medical Systems (NASDAQ:KRMD) ($2.31; $108.4M market cap), a home infusion therapy medical device company, announced Q3 2022 results:
Sales of $7.7 million vs $6.0 million in the prior year; ahead of analyst estimates of $6.7
Non-GAAP loss per share of $0.03 vs net loss of $0.02 in the prior year; ahead of analyst estimates of a loss of $0.05
“The third quarter marks another successful quarter for the Company with strong revenue growth across each of our businesses," said Linda Tharby, KORU Medical's President and CEO. "Delivering on our strategic objectives remains a primary focus, and the progress made this quarter is representative of continued solid execution by the team. We are excited by the momentum in our novel therapies business with multiple new collaborations this quarter and by the double digit growth performance in both our domestic and international core business."
Research
KORU Medical Systems (NASDAQ:KRMD) ($2.80; $127.4M market cap), a home infusion therapy medical device company, announced Q1 2022 results:
Sales of $6.2 million vs $5.4 million in the prior year; in line with estimates
Non-GAAP loss per share of $0.05 vs $0.00 in the prior year; in line with estimates
“I am extremely proud of our team in delivering strong first quarter results as we continue to execute our strategic growth plan to become a broader drug delivery provider. A rebounding U.S. immunoglobulin market is encouraging, and we are successfully driving a dual focus on increasing revenues in our core subcutaneous Ig business through expanded label indications and a growing prefill market, while expanding the Freedom platform into new drug areas,"
Guidance: (inline with analyst estimates)
For full year 2022, KORU Medical reaffirms expectations that the SCIg market will recover to a high single digit rate. Assuming this market growth holds, the Company expects full year 2022 revenue to be in the range of $26.5 to $27.0 million (previously $26.0 to $27.0 million).
The Company reiterates its guidance to exit the year at a 60% gross margin run rate. Additionally, Q1 2022 supply chain disruption impacts, which are not expected to recur, have resulted in unfavorable manufacturing variances, which will be recognized in the second quarter of 2022.
Research
KORU Medical Systems (NASDAQ:KRMD) ($3.17; $141.4M market cap), a home infusion therapy medical device company, announced Q4 2021 results:
Sales of $6.5 million vs $4.1 million in the prior year and ahead of analyst estimates of $6.1 million
Loss of $0.02 vs loss of $0.02 in the prior year and slightly ahead of analyst estimates of a loss of $0.03
“We are very pleased to finish 2021 with a strong fourth quarter. Driven by the efforts of our team, KORU Medical has seen momentum in all three areas of our business – domestic and international core business and novel therapies,” said Linda Tharby, KORU Medical’s CEO. “During the fourth quarter, we hit several key milestones, including three new 510(k) clearances, increased pump placements in our U.S. business, and four new agreements in our novel therapies pipeline. In addition, we announced our new strategic plan, including milestones that will drive accelerated revenue growth, margin improvement, and expansion of our total addressable market. We look forward to continued execution of our plan and driving long-term growth and value for our patients, customers, employees, and shareholders.”
Recall, the company provided year end guidance for 2021 during its investor day in December.
Research
KORU Medical Systems (NASDAQ:KRMD) ($3.34; $148.8M market cap), a home infusion therapy medical device company, held its investor day yesterday. During the presentation, the company provided Q4 and full year 2021 revenue guidance.
“the Company announced it expects the fourth consecutive quarter of positive sequential growth for the fourth quarter of 2021, and full year 2021 revenues to be between $23.0 million and $23.2 million. The Company also announced it expects the market for its domestic Sub-Cutaneous Immonuglobulin (“SCIg”) products to recover to mid to high single digits in 2022 and expects its revenue growth in domestic SCIg to be slightly ahead of that.”
The Q4 sequential growth guidance implies the company will beat the current Q4 estimate of $5.8 million and likely report close to $6.1 million.
Some other takeaways from the investor day:
“ And then looking at the targets that we have for novel therapies. So we're projecting 5 new large volume candidates getting through Phase III trials with KORU and 14 Phase III trials by 2031. And I think this is the great part, right? We don't need a lot of new drugs to commercialize. And what we're projecting here is, 1, commercialization and 5 by 2031. So where does that get us to a 2026 CAGR, somewhere between 15% and 20%, $60 million revenue projection and $200 million by 2031.”
“And we expect to see our first major drug outside of IG approved in early 2022. So I want to spend a minute talking about how the company has been known as being an IG therapy provider, and we're really looking to switch to being a broad home infusion drug delivery device provider. And as we've been out, expanding and beginning to get the KORU name out there with pharma companies, the biggest thing that we see here is why do we have such a compelling value proposition.”
Research
KORU Medical Systems (NASDAQ:KRMD) ($3.60; $160.1M market cap), a home infusion therapy medical device announced Q2 2021 results:
Sales of $5.5 million vs $7.7 million in the prior year; slightly ahead of analyst estimates of $5.3
Non-GAAP loss of $0.02 vs Non GAAP EPS of $0.02 in the prior year; in line with analyst estimates
“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," said Linda Tharby, KORU Medical's CEO. "We are focused on executing on our strategy, driving growth in our core SCIg therapy franchise through commercial efforts to increase penetration of home subcutaneous delivery, building a pipeline of subcutaneous therapeutic candidates and introducing product and technology innovations to generate further topline growth. "
Research
KORU Medical Systems (NASDAQ:KRMD) ($4.18; $190.8M market cap), a home infusion therapy medical device company sees director John Fletcher add 25,000 at average price of $4.30 in a form 4 filing from yesterday after the close.
Insider buying was one of our main catalysts in the KRMD story, you can see our full coverage on KRMD here .
Research
KORU Medical Systems (NASDAQ:KRMD) ($4.19; $184.0M market cap) , a home infusion therapy medical device company, announced a $10 million stock repurchase program.
"We believe that this repurchase program demonstrates confidence in our long-term outlook, the underlying value of KORU Medical stock, and our commitment to maximizing value for our shareholders,” said Don Pettigrew, Chief Executive Officer. “Our strong balance sheet enables us to support this repurchase plan, while continuing to invest in our operations and explore investments that generate long-term growth.”
The stock has pulled back a bit from its April 2020 high of $12.84, a 67% retracement.
Research
KORU Medical Systems (NASDAQ:KRMD) ($9.75; $387.0M market cap) , a home infusion therapy medical device company, announced settlement of all pending litigation with EMED.
“The agreement provides KORU Medical with freedom to operate under EMED’s existing patent portfolio, dismissal of all litigation with prejudice, and an equity payment by KORU Medical to EMED.”
While this is certainly a positive development to finally end the ongoing litigation with EMED, we would like to see the terms of the settlement to gain a better understanding of the full impact of the news.
Research
Repro Med Systems, Inc. dba KORU Medical Systems (NASDAQ:KRMD) ($10.23; $405.9M market cap) , a home infusion therapy medical device company, announced Q1 2020 results:
Sales of $6.3 million vs $5.0 million in the prior year
EPS of $0.01 vs $0.00 in the prior year
“The Company continued in Q1 2020 to capitalize on the growth of its primary end markets of Primary Immune Deficiency Diseases (“PIDD”) and Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) while pursuing longer-term growth initiatives, including broadening pharmaceutical relationships with an emphasis on the numerous new subcutaneous drugs coming to market, expanding indications beyond its primary disease states, and pursuing customers in new geographies...
...We are confident that KORU Medical will successfully navigate the challenges of COVID-19 and remain focused on achieving our long-term growth objectives,” continued Mr. Pettigrew. “We have not experienced any material disruption to our business thus far, continue to execute on our Strategic Plan, and are prudently managing working capital and cash flow. Longer term, we believe that the COVID-19 experience may accelerate the shift of drug infusion therapy to an at-home model and further advance the adoption of subcutaneous immunoglobulin drugs.”
Financials
Research
Repro Med Systems Inc (OOTC:REPR) ($2.85; $109.2M market cap) , a medical supply company, announced a favorable final judgment in its litigation with EMED Technologies.
“...on June 28, 2019 the United States District Judge for the Eastern District of Texas (Case No. 2:15-CV-01167-JRG-RSP) issued a Final Judgment in favor of RMS Medical in the Company’s previously announced litigation with EMED Technologies (“EMED”) before that court. The District Judge adopted the decision of the Magistrate Judge that was issued on June 24, 2019, overruled EMED’s objections, awarded court costs to RMS Medical, and dismissed the case. This case was one of several pending between RMS Medical and EMED.”
Analyst Reports
June 2019 Craig-Hallum Analyst Report
Research
GB Repro Medsystems (OOTC:REPR) ($1.45, $55.4M market cap) , a medical device company, continues to see share accumulation from one of its directors. Last week, we highlighted a possible coming proxy fight between the ex-CEO and the current board (in particular Joseph Manko, who has been steadily acquiring shares over the past year). Last week, Manko filed yet another two Form 4’s showing he added another 130,000 shares, bringing his total to 6.4 million shares. With ex-CEO Andrew Sealfon holding 8.1 million shares, it is possible Manko will continue to buy shares until he surpasses Sealfon, with the intention of holding more voting rights power than him.
Comments & Business Outlook
GB Repro Med Systems Inc (OOTC:REPR) ($1.37; $52.0M market cap), a medical device company announced Q1 2018 results :
Results are currently only via the 10-Q filing. Highlights from the management discussion and analysis portion:
The results of this year’s first quarter are an increase in net sales of 10.9% as compared with the same period last year, which included some variability due to a one-time back order issue. For 2018, we anticipate growth in our needle set sales including an updated Super 26g High Flo administration set, and general organic growth supported by a comprehensive updated new FDA clearance per the RMS “Integrated Catch-Up Freedom Syringe Drive Infusion System” which became effective on August 31, 2017. The expanded clearance includes specifications for use with Cuvitru® and Hizentra®, as well as intravenous antibiotics. The Super 26g High Flo administration set was developed specifically to support recent approval of immunoglobulins for the neurological treatment of Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Our gross margin percentage increased from 57.7% to 61.1% quarter over quarter, driven by ongoing operational efficiencies. With improved sales, better margins and level operating expenses, net income improved significantly. In addition, we expect many of the SCIg providers, and others, will see benefit in using the FREEDOM System for additional uses such as neurology, antibiotics, chemotherapeutics, and pain medications.
Research
GB Repro Med Systems Inc (OOTC:REPR) ($1.30; $49.4M market cap), a medical supply company, nominated Daniel Goldberger to the Board of Directors.
"As part of the comprehensive strategic review announced November 22nd, in an effort to prepare the Company for anticipated growth, the Board of Directors is committed to strengthening its membership and governance. We are very pleased to nominate Dan and thank Brad for his service to the Company. We have nominated Dan to join our board because he will bring valuable expertise and a new perspective to our business," said Andy Sealfon, RMS Chairman, and Chief Executive Officer. "Dan has extensive executive and board experience in the healthcare industry and will be instrumental to the board in guiding our growing Company to continue to drive shareholder value.
Mr. Goldberger has held senior leadership and board of directors positions at high growth medical technology companies including Xtant Medical Holdings, Sound Surgical Technologies LLC, Xcorporeal, and Glucon. As Chief Executive Officer of Xtant, he oversaw a tripling of sales from $30 million to $90 million over a three and one-half year period. He also guided Xtant through a period of improved profitability and substantially increased shareholder value. With Sound Surgical, he helped boost revenue from $9 million to $40 million over six years through a strategic restructuring and new product development.”
It seems like activist investor Joseph Manko Jr. is beginning to clean house. In November 2017, the company announced that the Board, in preparation for accelerated growth, has committed to strengthening its membership and governance in the coming months. The hiring of Daniel Goldberger to the Board and the continued search to replace the CEO Andy Sealfon seem to be the first steps in this process.
Research
GB Repro Med Systems Inc (OOTC:REPR) ($1.35; $51.0M market cap), a medical device company, continues to see aggressive buying by director Joseph Manko. Five days after our last note that showed Manko adding over 100,000 shares to his already massive stake of over 6 million, he has filed another form 4 yesterday adding an additional 58,000 at average price of ~$1.34.
Research
GB Repro Med Systems Inc (OOTC:REPR) ($1.35; $51.0M market cap), a medical device company, continues to see aggressive buying by director Joseph Manko Jr. In a Form 4 filed yesterday after hours, Manko disclosed adding another 109,300 shares to his already massive stake of over 6 million shares. The shares were purchased in the open market at an average price of ~$1.30. Manko now has a ~16.2% stake in REPR.
Comments & Business Outlook
GB Repro Med Systems Inc (OOTC:REPR) ($1.07; $40.5M market cap), a medical supply company announced Q4 2017results :
Quotes from management:
"I am so pleased to announce that due to the outstanding performance and expanded market acceptance of our FREEDOM Syringe Infusion System, as well as the confirmation by the FDA of the unique technology supporting the use of our system for subcutaneous medications including Hizentra® and Cuvitru®, as well as for intravenous uses such as antibiotics, we experienced our best year ever in the Company's history for net sales and profitability. With new markets opening, planned introduction of new products this year, multiple new clinical trials underway, and international market expansions, we believe we are well positioned for future growth."
Looks to be first time the Company has surpassed $4 million in sales for a quarter.
Research
GB Repro Medsystems (OTCQX:REPR) ($0.62; $23.4m market cap) , a medical device company, recently announced its Q3 2017 results via 10-Q which we highlighted in our November 6, 2017 email . The company posted:
The company had only issued the 10-Q filing, but yesterday after the close followed up with a press release. Commentary included:
"Sales growth continued for the current quarter and while expanding internationally, we generated our first sales in Asia and Africa." Sealfon continued, "The FDA issued a new 510(k) clearance for our Integrated Catch-Up Freedom Syringe Driver System, the first ever fully integrated 510(k) cleared system by the FDA, confirming the science behind the performance of using the dedicated RMS system. It is also the only mechanical infusion system cleared for both subcutaneous drugs (SCIg) and intravenous (antibiotics), clearing the path for customers to invest in one system to meet all their needs."
Note that the information arbitrage we pointed out in our update was not mentioned in the release. The 10-Q stated that for the first time the Company anticipates the Warning Letter to be closed in the near future, a noticeable omission from the release.
Research
Repro Medsystems (OTCQX:REPR) ($0.62; MC $23.4m ) reported Q3 2017 results (company recently changed its fiscal year end from February to December).
Information Arbitrage ( InfoArb ) from 10-Q (no press release issued)
In its 10-Q filing the company discusses its ongoing saga with the FDA warning letter. The language in this 10-Q states for the first time that the Company anticipates the Warning Letter to be closed in the near future.
Shares hit a new 52-week high of $0.68 on the heels of the 10-Q filed mid-day Friday.
Research
REPR ($0.46) hit a new 3-month high. Shares have slowly been inching up since we discussed the slight InfoArb opportunity presented in the Company’s 10-k filing on May 5, 2017. For those unfamiliar with the REPR story, the stock has been stuck in limbo since the FDA issued a warning letter concerning the company’s Freedom60 Syringe and Freedom Edge Infusion Pumps on February 26, 2016. In our May 5, 2017 note , we stated that there were some positive signs in the 10-K that led us to believe that the Company may finally get past the FDA issue and be able to purely focus on increasing sales momentum. Specifically, we found it interesting that management issued some commentary, suggesting that sales will be grow over the next 18 months. As far as we can recall, management has never in the past issued inferences to guidance. Unfortunately, since the FDA letter, the CEO has been somewhat unreachable, so we have been unable to secure an interview with him. We continue to believe that, barring an FDA setback, REPR has meaningful upside.
Comments & Business Outlook
REPR ($0.42) established a new medical advisory council.
“The members of this council are highly respected medical professionals and key opinion leaders in the immunology, allergy and immunodeficiency medical arena. The role of this council will be to advise the RMS Leadership Team in the area of research, product development, continual improvements, clinical studies and global expansion efforts. The council will also provide post marketing medical education to promote the safety and effectiveness of RMS' products and enhance the communications and networks between RMS, medical specialty pharmacy and nursing societies.”
REPR is the leading manufacturer of medical products used for home infusions and suctioning.
Research
REPR ($0.44) - Another Form 4 from Horton Capital Management was filed on Friday, after hours. Joseph Manko of Horton Capital Management filed another Form 4 showing he added 15,000 shares to his position in REPR. Horton now owns 5.76 million shares.
