Printable Weekly
Earnings
Exactech pre-announced 4Q:11 sales of $53.1 million, up 3% over the year-ago period. Analysts had forecast 4Q:11 revenues of $53.7 million. The company expects knee sales to decrease by 2% for the quarter; extremities sales to increase by 29%; hip sales to increase by 13%; biologic & spine sales to decrease by 21%; and "other" revenue to decline by 4%.
Kensey Nash reported F2Q:12 sales and royalties of $23.0 million, up 32% over the year-ago period and missing estimates by $1.3 million. Orthopedic sales increased by 53% after adjusting for the impact of the Norian acquisition. Adjusted EPS was $0.51, compared to $0.38 in F2Q:11, and beat estimates by $0.05.
RTI Biologics reported 4Q:11 revenues of $42.9 million, up 2% over the year-ago period and beating estimates by $1.7 million. The company attributed performance to "the strength of the sports medicine and [bone graft substitutes/general orthopedic] businesses. Net income for the quarter was $2.4 million, or $0.04 per share, which compares to net income of $2.8, or $0.05 per share, in 4Q:10. Analysts had forecast EPS of $0.03.
Smith & Nephew reported 4Q:11 revenues of $1.1 billion, up 3% over the year-ago period and missing estimates by $26.0 million. Orthopedics revenue was flat at $586.0 million; recon was flat, with knee up by 2% and hip down by 2%. Trauma declined by 2%. Clinical Therapies increased by 8%. Endoscopy sales increased by 7%. Growth rates exclude the effects of currency. Adjusted EPS was $0.22, in line with the prior year and beating estimates by a penny.
Funding
CartiHeal raised $5.0 million in venture funding from two U.S.-Israeli venture capital firms, Accelmed and Access Medical Ventures. The financing will be used to prepare its first product launch early 2013 in Europe. The company is developing proprietary, off-the-shelf and cell-free cartilage regeneration technology.
Checkpoint Surgical completed a $1.7 million Series B investment round led by the NDI Healthcare Fund in December 2011. The company also secured non-dilutive funding of over $1.3 million, including a $1.1 million Innovation Ohio loan and a $245,000 federal grant. The company manufactures the CHECKPOINT Stimulator/Locator, a hand-held, intraoperative nerve and muscle stimulator that helps surgeons to locate, identify and evaluate nerves during surgery to facilitate nerve preservation and repair.
ConforMIS raised $89.0 million in a Series E round of funding, with additional funds beyond this amount committed upon meeting certain milestones. The company will use the funds to support ongoing sales and marketing expansion, R&D investment into new product lines and build-out of manufacturing infrastructure. The investments originated from private equity funds in the U.S., Europe, Asia and the Middle East. Principal investors in the round include AGC Equity Partners and Axel Johnson, Inc., along with Government Investment Funds from Asia and the UAE.
Regulatory
Custom Spine announced that it has achieved ISO-13485 and received CE mark certification for all its current products sold in the U.S., including the ISSYS LP pedicle screw system.
Eden Spine received 510(k) clearance for its GIZA corpectomy device. The GIZA is an expandable titanium VBR with rotatable endplates that the company says "provide multiple angulation options by simple endplates rotation."
FH Orthopedics received 510(k) clearance for its PEEK fixation screws for the CoLS technique, which are designed for fixating the tendon graft to the femur and tibia during ACL and PCL reconstructive surgeries.
NLT SPINE received 510(k) clearance for its PROW FUSION Transforaminal-Lumbar Interbody Fusion device and delivery system. The company says that that the PROW FUSION offers a larger footprint than competitive devices, which is intended to provide "greater biomechanical stability and less subsidence postoperatively."
Product Introduction & Update
Spectrum Surgical Instruments Corporation launched a Large Orthopedic Pin Cutter. The pin cutters are stainless steel, fully-autoclavable and able to cut orthopedic pins up to 1/4" in diameter.
ThermoGenesis announced updates on clinical evaluations involving its Res-Q 60 BMC system, a point-of-care platform designed for the preparation of cell concentrates from bone marrow, in the treatment of critical limb ischemia and long bone fractures. The company said the results "demonstrate encouraging preliminary results with stem cell concentrates."
Intellectual Property
Interventional Spine announced that the United States Patent Office has issued U.S. Patent No. 8,105,382, entitled "Intervertebral Implant." This patent covers the company's expandable interbody fusion device, the Opticage.
Distribution and Licensing
BioRestorative Therapies entered into a License Agreement with Regenerative Sciences, LLC with respect to certain stem cell-related technology and clinical treatment procedures developed by RS. The company describes this treatment as an advanced stem cell injection procedure that may offer relief from lower back pain, buttock and leg pain or numbness and tingling in the legs or feet as a result of bulging and herniated discs.
Reuters and others are reporting this morning that the FDA and industry have reached an agreement for the FY2013 re-authorization of MDUFA, the legislation that allows the FDA to collect user fees from industry. User fees contribute about a third of the agency's budget.
After a long negotiation process, including one missed deadline last month, industry has reportedly agreed to pay the FDA about $595 million over the next five years, up from $287 million in MDUFA II. Minutes from a January 31 meeting between industry and the agency cite the $595 number, and assuming other details from that proposal are included in the final agreement, funds will be used to support hiring additional staff, process improvements and IT upgrades.
Specific goals discussed at the January 31 meeting include PMA decisions within 320 FDA days, if the submission goes to panel, with targets to ramp up from 50% of submissions received in FY13, to 70% in FY14, 80% in FY15-16 and 90% in FY17. For 510(k)s, the FDA proposed a decision within 90 FDA days, ramping up from 90% of submissions in FY13-14 to 95% in FY15-17. Reuters reports that the FDA has also agreed to "hire an outside consultant to analyze its review system."
Posted Jan 31, 2012 by Matthew Jaffe
Earnings
Align Technology announced 4Q:11 net revenues of $128.9 million, up 38.8% from the quarter a year ago and beating analyst estimates by $0.03 per share. Net profit for 4Q:11 was $20.4 million, or $0.25 per diluted share, compared to 4Q:10 net profits of $9.9 million, or $0.13 per diluted share. FY:11 net revenues were $479.7 million, up 23.9% from $387.1 million for FY:10. Net profits for FY:11 were $66.7 million, or $0.83 per diluted share, down from $74.3 million, or $0.95 per diluted share the previous year.
Zimmer reported FY:11 dental sales of $248 million, a 13% increase (12% constant currency) over the previous year. For the fourth quarter, they reported dental sales were $63.5 million, up 2% both as reported in constant currency.
Regulatory
Align has received a Product Registration Certificate from the Federal Service of Health Care and Social Development Control of the Russian Federation. This will allow them to expand sales of Invisalign in to Russia. They are additionally expanding Middle East distribution to from Turkey to include Dubai and Saudi Arabia.
Product Introduction and Update
Align Technology released Invisalign Express 5. It is described as a lower cost option for patients who need five stages of aligners or less for their treatment. A patent uses on average 24 aligners in a year.
Collaborations
Biomet 3i and Sirona have collaborated on Sirona’s CEREC Interoral Scanner to create digital impressions for Biomet’s BellaTek Encode Impression System.
Appointments
Sirona announced that Nicholas W. Alexos and Timothy D. Sheehan were leaving the Board of Directors. After their departure, the board will be formed from three members from the management team and six independent directors.
Symmetry Medical announced after the close on Monday that the SEC has settled an investigation into accounting irregularities at the company's Sheffield, UK manufacturing site, which were first exposed in 2007. Four former finance executives were implicated in the SEC's probe, and in a separate clawback action, Symmetry's former CEO and current CFO were ordered to repay compensation associated with the faulty accounting.
The SEC alleged that four former executives at Symmetry's UK site overstated revenues and assets while understating expenses over a three-year period between 2004 and 2007. The executives have settled with the SEC, and two have been ordered to repay any profits, with interest, associated with the inflated financials. Also impacted were the company's former CEO Brian Moore and current CFO Fred Hite, who were ordered to repay to the company $450,000 and $185,000, respectively, associated with the accounting issues. Mr. Hite will also pay a $25,000 penalty associated with the oversight. Mr. Moore, who currently serves President of Business Development, is said to have had no knowledge of the accounting scheme in Sheffield.
Thomas Sullivan, who succeeded Mr. Moore as CEO, stressed in yesterday's announcement that, "This settlement agreement allows the company to move beyond the accounting irregularities at our Sheffield, UK facility several years ago. We will now be able to direct our full focus on executing our business strategies."
As evidenced with Symmetry as well as the Stryker OP-1 investigation, regulators are increasingly willing to pursue individual executives and employees amid allegations of wrongdoing. In this case, culpability was expanded even to the company's auditors. The SEC suspended two auditors from Ernst & Young for at least two years based on a failure to properly audit the UK accounts.
We're in Paris for the 16th annual ArgoSpine Symposium. Each year, ArgoSpine selects a theme for the event, and the latest is disorders in the junctional regions of the spine (previous topics have included the recent history of spine surgery and spine imaging). Industry presence is much lighter than is typical at these events, with commercial exhibits limited to single tables from the handful of sponsoring companies. The focus is instead clinical - surgical technique, treatment modalities and optimizing outcomes.
Junctional spine disorders encompass a number of clinical scenarios, and topics over the two-day conference ranged from navigating complex anatomy to treating trauma, osteoporotic bone and cancer. Promoting new technologies took something of a backseat to interactive discussion of actual cases and more commonly used treatments. However, the benefits of percutaneous versus open surgery were debated, as was the use of endoscopy, appropriate imaging and whether the fairly new treatment of vertebral body stents was "the future" for VCFs.
Overall, the past two days provided a brief education on the junctional spine as well as insight into the European perspective on spine trends and treatments. HealthpointCapital is proud to be among ArgoSpine's sponsors.
Earnings
DJO announced preliminary 4Q:11 sales of $284.1 million, up 14% over the year-ago period. The company said this was "driven by a combination of new product launches, improved sales force execution and improved quality and customer service." Excluding the impact of acquisitions, pro forma sales increased by 3%. Among segments, Bracing and Vascular sales increased by 4%; Recovery Sciences declined by 1%; International increased by 6%; and Surgical Implant sales increased by 5%. Growth rates exclude the effects of currency.
Johnson & Johnson reported 4Q:11 sales of $16.3 billion, up 4% over the year-ago period and missing estimates by $24.7 million. DePuy sales were flat at $1.5 billion, with the company adding that "strong sales in sports medicine were partially offset by lower sales for knee and spine products." Hip sales were up 1%; knee declined by 3%; and spine was down 3%. Adjusted net earnings for 4Q:11 were $3.1 billion, or $1.13 per share, up 9% over the year-ago period and beating estimates by $0.04.
Life Spine announced record revenues in 2011 and 29% sales growth over 2010. The company launched 14 new products over the past year.
Medicrea reported 4Q:11 sales of EUR 4.1 million ($5.3 million). The company calls full-year sales "disappointing," attributing the slower sales growth partially to changes in the U.S. sales structure.
Stryker announced 4Q:11 sales of $2.2 billion, up 11% over the year-ago period and in line with a pre-announcement. Reconstructive sales increased by 1%, with hip flat, knee down by 2% and trauma and extremities up by 8%. Sales in the Neurotechnology and Spine division increased 47% as reported and 2% in constant currency after adjusting for acquisitions; spine sales alone increased by 6%. Growth rates exclude the effects of currency, unless otherwise noted. Adjusted net earnings for 4Q:11 were $390.0 million, or $1.02 per share. EPS increased by 10% over the year-ago period and was in line with estimates.
Zimmer reported 4Q:11 sales of $1.2 billion, up 2% over the year-ago period and beating estimates by $6.0 million. Among segments, recon sales increased by 2%, with knee flat, hip up by 4% and extremity up by 9%. Dental sales increased by 2%; trauma increased by 11%; and spine declined by 6%. Growth rates exclude the effects of currency. Net earnings declined by 2% during 4Q:11 to $245.0 million, or $1.36 per share. EPS beat estimates by $0.02.
Regulatory
Interventional Spine received 510(k) clearance of its Opticage Expandable Intervertebral Body Fusion Device. The device is part of the PerX360 System, which the company says enables a surgeon to perform a complete percutaneous lumbar interbody fusion via two 15mm incisions for the treatment of lumbar discogenic pain.
Medtronic received 510(k) clearance for the Aquamantys SBS 5.0 Sheathed Bipolar Sealer, which provides hemostatic sealing capabilities for both incised soft tissue and epidural veins with a single device.
Suspension Orthopaedic Solutions received 510(k) clearance for two new products, the Distal Clavicle Fracture Fixation System and a plate designed to address repair of mid-shaft clavicle fractures. The company says the Distal Clavicle Fracture Fixation System features Suspension's patent-pending T-Loc Technology, which "enables knotless, protected and precisely controlled tension" for fixation of multiple soft-tissue injuries, and the Mid-Shaft Clavicle Plate "creates a complete clavicle system".
Product Introduction and Update
Choice Spine launched the Starfire Pedicle Screw System, which the company says features top-loading polyaxial screw implants that "can address a variety of patient anatomies, including small and large-sized patients."
Intellectual Property
KFx Medical was granted U.S. Patent No. 8,100,942, covering knotless double row rotator cuff repair. They added that the new patent follows an anonymous request that the USPTO re-examine the company's first patent, also covering knotless double row rotator cuff repair. The patent office rejected the arguments from the anonymous party and upheld the patent.
Legal
A federal court denied motions from Medtronic and NuVasive ahead of a Thursday hearing on an ongoing patent infringement case. Medtronic asked for an injunction that would prevent NuVasive from selling products that infringed its patents, and NuVasive requested a dismissal of $101.2 million in damages stemming from a jury decision in September. Today's hearing will go on as scheduled.
Operations
Pioneer Surgical Technology announced the grand opening of its newly-expanded Greenville, North Carolina manufacturing facility, which houses the primary manufacturing operations for Pioneer Surgical's biologic products sold in the United States and Europe.
Appointments
DJO announced that on January 5, 2012 its Board of Directors elected Mike S. Zafirovski as a member of the DJO Global Board and as non-executive Chairman of the Board. Mr. Zafirovski will succeed Les Cross as Chairman, though Mr. Cross will remain a member of the Board of Directors.
