2Bob
- 05 Jan 2006 23:30
The succesful LOM AGM for the 2004 financial results was held on Friday 30th December. [LMT will likely hold their AGM for 2005 results in late Q2 '06] The AGM was a chance to meet the new team running LMT. The new CEO and FD are sharp and focussed, which is good news. The CEO whilst at Boston built up his segment from $50M sales p/a to $200M p/a. One senses he sees the opportunity to do likewise with the market cap of LMT.
The portfolio of opportunity remains the same but by way of a recap:-
Grafts
AAA grafts (Aortic)
Boston has extended their agreement to allow further time to evaluate the Aorfix graft. With this area being very litigious [threat of board members of US company Guidant going to jail.] and the difficulties thrown up by TriVascular a small AAA graft company which they recently purchased their desire to cover all bases is understandable. Boston will have to set up and train a sales force to sell the graft so it is a major decision for them. If they can make up their mind by summer LMT are in contact with other major suppliers who wish to distribute the AAA graft outside the US.
The US FDA has conditionally approved the AAA graft IDE to allow a US trial called PYTHAGORUS to begin very soon. Initially a few tens of 1st Generation grafts will be implanted at which stage the FDA will review and then if everything is okay allow the 2nd Gen graft to be used and the scope of the trial to be widened to grafts with angulated necks greater than 60 degrees. There will be 275 grafts used in cases with angulation less than 60 degrees and 110 grafts for cases greater than 60 degrees angulation. The upside is that the clinical centres who have signed up for the trial will pay for the grafts which retail at $10-$12k each. With discounts LMT might achieve $9-$10K. All grafts are expected to be implanted in 2006 therefore LMT can look forward to an income of around $3.5M this year from the US. If the clinical centres require additional grafts then LMT can continue to sell them until FDA approval comes through so similar income may be available in 2007 and 2008.There are no grafts in the EU capable of dealing with angulated and although the Aorfix is not yet approved it is already finding use in compassionate cases.
The rights for the US market have still to be licensed, but clearly Boston is the frontrunner. To obtain the best price LMT will no doubt show they have other interested parties who are keen to step in if they should falter.
TAA Grafts (Thoracic)
Now that money is available clinical trials are expected to start in Europe and the US. The TAA market could be worth $500-$1000M in the next years 3. The size of the market depends on the capability of the graft which will be demonstrated by clinical trial results. A sales partner has still to be appointed.
Staplers
LMT has at least 3 versions of their stapler
Open stapler for use in surgery
Endovascular stapler for use in fixing AAA grafts that have moved or heart tissue valves
GI stapler - subject of a deal with Wilson Cook some years back
The value focus is currently on the Endovascular stapler with FDA 510(k) and CE mark approvals awaited. Distribution deals are likely to be interesting and lucrative.
Polymers
Polybiomed are working
with a US major on multidrug delivery using their polymer
with an EU stent company on multidrug delivery using their polymer
with a major biotech on delivery of an innovative restenosis drug
on a gel wound dressing
on a coated urinary catheter
Unquoted investments
Investments continue to be made into Endoart to protect their shareholding, but its value has been written down to nil in the most recent accounts I have seen. The two events do not seem consistent. Perhaps it will be revalued in the accounts for the year just ended.
Vascular Concepts is making money in the Indian drug eluting coronary stent market. It is still seeking investment to break into the EU and US markets.
Stock overhang?
It is interesting to note that at IPO there were no stock sales apart from that held by the new non-executive director. As the company strategy has evolved over the years it has divested businesses such as AME and DMC and dropped a number of directors and executives along the way. All of these will have shareholdings and may now be sitting watching and wondering if they should sell now they have the opportunity. At the AGM it was reported that presentations had been made to 42 institutions from across Europe of which 24 had subscribed for shares with one taking 10% of those on offer. Raising 26M is a big achievement - but more money was on offer.
With Code holding the price any stock sold may just be ending up in the hands of institutions that didn't get in at the offer. We also know the way that many IPO's work - not all the good news comes out at IPO which allows a flow of news to follow which puts some air into the price and a comfort zone to those that invested.
There is a new executive team under the Chairman, the brokers Nomura/Code Securities are first rate, and the media advisors Financial Dynamics are first division as are the new legal team at Berwins. Of course as jpon points out the website still lacks, but that was said to be under very active development.
In essence it is a new start building on the foundations already laid so it does not make much sense to sell just when the dawn is breaking. It makes more sense to be buying.
skinny
- 24 Sep 2014 14:40
- 92 of 106
stable
- 08 Jan 2015 11:46
- 93 of 106
Lombard announce 4th quarter and end year results
Looks promising for long term holders
skinny
- 08 Jan 2015 11:55
- 94 of 106
stable
- 27 Feb 2015 08:12
- 95 of 106
results yesterday, no chance of profits for a year or two but good future predictions, all available on company web pages
stable
- 26 Mar 2015 19:32
- 96 of 106
report today with analyst views. long term hold
skinny
- 27 Mar 2015 06:45
- 97 of 106
It certainly is!
stable
- 09 May 2015 17:21
- 98 of 106
Monday 16.30 should see first quarter results.
let us see how they have done against last year
stable
- 11 May 2015 22:07
- 99 of 106
1st quarter results after close today show continued expansion, with forecast for year expecting same to continue.
Still expanding product range, expenses up, as is profit margins.
still holding, although expect it to be a long hold
stable
- 11 May 2015 22:07
- 100 of 106
1st quarter results after close today show continued expansion, with forecast for year expecting same to continue.
Still expanding product range, expenses up, as is profit margins.
still holding, although expect it to be a long hold
stable
- 20 Jul 2015 21:53
- 101 of 106
6 monthly figures to be announced after close next Monday.
stable
- 20 Jul 2015 21:54
- 102 of 106
after close next Monday , 1/2 year results to be announced
stable
- 27 Jul 2015 21:20
- 103 of 106
Q2 and Recent Operational Highlights
• Total 2015 second quarter Aorfix™ revenue grew 107 percent1 to $4.5 million compared to revenue of $2.2 million in the second quarter of 2014.
• U.S. Aorfix revenue grew to $1.3 million in the second quarter of 2015, up 123 percent from $0.6 million in the second quarter of 2014.
• Gross margin for the 2015 second quarter was 52 percent compared to 46 percent for the prior year period.
• Opened new Innovation Center in Irvine, California.
• In June, the first clinical cases using the new 34mm Aorfix Plus™ endovascular stent graft were successfully completed in the U.S. Up to 10 percent more AAA patients have the potential to be treated with Aorfix as a result of this expanded size range.
Operational and Financial Results
With U.S. procedures that more than doubled, global Aorfix revenue increased 107 percent1 to $4.5 million in the second quarter of 2015 compared to $2.2 million in the second quarter of 2014. For the first six months of 2015, global Aorfix revenue grew 87 percent1 to $7.9 million compared to $4.3 million in the year-earlier period.
In the U.S., where Aorfix was formally launched in November 2013, and is sold exclusively through the Company’s own sales force, revenue in the 2015 second quarter and first six months was $1.3 million and $2.4 million, respectively. Comparative U.S. revenue in the 2014 second quarter and first six months was $0.6 million and $1.1 million, respectively.
"We had another solid quarter of rapidly growing procedures and revenues across key markets while making significant progress on our key commercial, regulatory and strategic initiatives,” said CEO Simon Hubbert. “In the U.S., we added new physicians and new centers to our growing list of customers. We also launched Aorfix Plus, a new addition to our portfolio that allows us to treat patients with larger aortic neck diameters that we believe expands our addressable market by about 10 percent. In Japan, as a result of continued strong procedural growth, we estimate that we have captured approximately 5 percent market share within nine months of launching Aorfix.”
In Japan, where Aorfix is sold through the Company’s exclusive distributor, Medico’s Hirata, and where regulatory approval was received in August 2014, revenue in the 2015 second quarter and first six months was $1.8 million and $2.7 million, respectively. There was no comparative revenue in the second quarter and first six months of 2014.
Gross margin for the 2015 second quarter and first six months was 52 percent and 49 percent, respectively, compared to 46 percent and 40 percent for the prior year periods. The improvement was primarily due to the effect of higher average U.S. selling prices and the spreading of fixed manufacturing costs over increased production volumes.
Total operating expenses for the 2015 second quarter and first six months were $10.6 million and $21.9 million, respectively, compared to $12.4 million and $20.2 million in the prior year periods. The net loss for the second quarter of 2015 was $8.2 million, or $0.51 loss per share, compared to a net loss of $11.1 million, or $0.76 loss per share, for the second quarter of 2014. The net loss for the first half of 2015 was $17.7 million, or $1.10 loss per share, compared to $18.0 million, or $1.49 loss per share, for the first half of 2014.
stable
- 30 Jul 2015 21:22
- 104 of 106
Report of Foreign Issuer (6-k)
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Alert
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
____________________
FORM 6-K
____________________
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934
July 30, 2015
____________________
Lombard Medical, Inc.
(Exact Name of Registrant as Specified in Its Charter)
____________________
N/A
(Translation of Registrant’s Name into English)
____________________
Cayman Islands 3841 Not applicable
(State or other
jurisdiction of
incorporation or
organization) (Primary Standard
Industrial
Classification Code
Number) (IRS
Employer
Identification
Number)
4 Trident Park
Didcot
Oxfordshire OX11 7HJ
United Kingdom
+44 (0)1235 750800
(Address, Including ZIP Code, and Telephone Number, Including Area Code, of Registrant’s Principal
Executive Offices)
____________________
Lombard Medical, Inc.
15420 Laguna Canyon Road
Suite 260
Irvine, CA 92618
(Name, Address, Including Area Code, of Agent for Service)
____________________
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ x] Form 40-F [ ]
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):
Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Lombard Medical, Inc. dated July 30, 2015, announcing the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Lombard Medical, Inc.
(Registrant)
Date: July 30, 2015 /s/ WILLIAM J. KULLBACK
William J. Kullback
Chief Financial Officer
EXHIBIT 99.1
Lombard Medical Acquires Endovascular Stent Graft Developer Altura Medical
Acquisition Expands Lombard Product Portfolio with Simple, Safe and Efficient Ultra-Low Profile Endovascular Stent Graft
CE Mark in Place – European Launch Scheduled for January
IRVINE, Calif., July 30, 2015 (GLOBE NEWSWIRE) -- Lombard Medical, Inc. (NASDAQ:EVAR), a medical device company focused on endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAAs), today announced the acquisition of Silicon Valley-based Altura Medical, a privately-held, venture-backed company that has developed an innovative ultra-low profile endovascular stent graft technology that offers a simple and predictable solution for the treatment of standard AAA anatomies.
The terms of the transaction include the issuance of $15 million of Lombard common stock at $4 per share (3,750,000 shares of Lombard common stock subject to certain lock up conditions), the assumption of $5.5 million in bank debt and $2.5 million in certain liabilities and transaction-related costs.
In addition, up to $27.5 million may be paid based on the achievement of certain commercial and regulatory milestones anticipated over the next five years. Under the terms of the agreement, Lombard has the option to pay the additional consideration in either cash or stock.
The Altura endograft system received CE Mark in 2015 and Lombard plans to launch the device in Europe in January 2016 with a broader international roll out later the same year. In the U.S., Lombard intends to file for an IDE (Investigational Device Exemption) from the U.S. FDA in early 2016 with the intent to begin recruitment for a U.S. clinical study later in 2016.
Lombard CEO Simon Hubbert said, "The acquisition of Altura and the launch of its new AAA stent graft will provide a near-term and substantial increase in revenues. In fact, we believe this innovative technology could account for up to 20 percent of our 2016 total revenue. The combination of Altura's technology with our flagship Aorfix™ platform creates a truly patient driven platform that we believe will allow us to capture share from our competitors. The Altura device offers a simple, safe and efficient treatment option for standard AAA anatomy, while Aorfix offers the only on-label solution for patients with Aortic neck angulation up to 90 degrees."
"The Altura device offers a new ultra-low profile stent graft system without compromising the robustness and durability of the wire and graft fabric," said Professor Dierk Scheinert, M.D., Chairman of the Division of Interventional Angiology, University Hospital Leipzig, Germany. Noting that, "The added benefits of this smart system are the ability to reposition during deployment and place each graft accurately to each renal artery enabling physicians to utilize all the available aortic neck. It also removes the need for cannulation and therefore provides a simple, intuitive, safe and consistent deployment system with predictable and shorter procedure times."
"Many patients who present for AAA repair can be treated quickly and efficiently with minimal hospital stay and recovery times," said Stuart A. Harlin, M.D., board certified vascular surgeon, Coastal Vascular & Interventional, Pensacola, FL. "The introduction of an easy-to-deploy AAA stent graft that offers enhanced safety and accuracy on an ultra-low profile delivery system will allow physicians to treat a large percentage of AAA patients more efficiently in the future."
Conference Call
Lombard's management will discuss the acquisition and answer questions during a conference call, which will include a slide presentation, beginning at 5:00 p.m. Eastern Time today, Thursday, July 30, 2015. To join the call, participants may dial 1-855-327-6837 (domestic), 0808-101-2791 (UK toll-free) or 1-631-982-4565 (international). To access the slide presentation and/or listen to a live webcast of the conference call, visit the Events and Presentations page under the Investors tab at www.lombardmedical.com. Phone participants who are accessing the slides from the webcast link should, after completing the registration, click the "Listen by Phone" black box under the smaller screen on the left hand side to turn off the webcast audio and sync the slides to the phone audio.
An archived replay of the webcast will be available shortly following the completion of the call on the Events and Presentations page under the Investors tab at www.lombardmedical.com.
About Altura Medical, Inc.
Founded in 2008 and based in Menlo Park, CA, Altura Medical has developed a next generation endograft technology to treat AAA and other related conditions. The development of Altura's highly differentiated technology was led by experienced technologists and supported by a prestigious syndicate of venture capital investors, including SV Life Sciences, New Leaf Ventures and Advanced Technology Ventures. Andrew Cragg, MD, a prolific physician inventor, entrepreneur and a principal at Intersect Partners, initially conceived the Altura AAA endograft technology.
stable
- 05 Aug 2015 11:34
- 105 of 106
CEO (500shares) and Chairman (1000) purchased 4th August
stable
- 05 Nov 2015 10:16
- 106 of 106
third quarter results out yesterday, no surprises and as always hi hopes for the future