ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI) (NASDAQ: CSII), a medical accessory aggregation developing and commercializing avant-garde interventional analysis systems for borderline and coronary avenue disease, today appear banking after-effects for its budgetary third division concluded March 31, 2016.
The company’s third-quarter revenues were $44.5 million, a 7% admission from the added division of budgetary 2016 and a 1% abatement from the third division of aftermost year, excluding acquirement from Asahi adviser affairs in the prior-year period. Coronary revenues added 31% year over year to $10.5 million. The third-quarter gross accession allowance added to 80.4% from 77.8%, primarily absorption assemblage amount reductions over the prior-year period.
Third-quarter operating costs included $12.4 actor of ancient costs accompanying to ahead appear events, including an estimated Department of Justice settlement, restructuring accuse from a workforce abridgement and CEO retirement benefits. Excluding the ancient costs, operating costs were 5% lower than the added division of this budgetary year and 2% beneath than the prior-year period, absorption the company’s focus on amount administration and charge to acclimation acquirement advance with establishing a alleyway to approaching profitability.
Scott Ward, CSI’s Chairman, Interim President and Chief Executive Officer, said, “This division we fabricated cogent advance against accomplishing our near-term goals of stabilizing the sales force and resuming after anniversary acquirement growth, accomplishing a 7% admission over the added budgetary division of this year. We attending advanced to added advance and accretion abundance as our sales force continues to accretion acquaintance and administration in their accounts. Furthermore, we’ve taken cogent accomplishments to realign our amount structure, including an 8% abridgement in our workforce at the end of the third quarter. These accomplishments bigger adjust our amount anatomy with revenues and position CSI to advantage acquirement advance for absolute banknote breeze and advantage in the future.”
Budgetary 2016 third-quarter net loss, including the $12.4 million, or $(0.38) per share, of ancient costs, was $(22.7) million, or $(0.69) per accustomed share. This compares to a net accident of $(10.7) million, or $(0.34) per accustomed share, in the budgetary 2015 third quarter. Adjusted EBITDA accident was $(18.6) actor against $(6.1) actor a year earlier. Excluding ancient costs, Adjusted EBITDA accident was $(6.4) million. Banknote acceptance for the division beneath decidedly to $(3.2) million, consistent in a banknote antithesis of $62.2 actor at division end.
COAST 30-Day Abstracts Highlighted at CRT 2016 and SCAI 2016Dr. Richard Shlofmitz of Saint Francis Hospital in Roslyn, N.Y., presented 30-day abstracts from the Coronary Alternate Atherectomy Arrangement Balloon (COAST) abstraction in a late-breaking presentation at the Cardiovascular Analysis Technologies (CRT) appointment in Washington, D.C., in February, and at a analytic analysis presentation at the 2016 Society for Cardiovascular Angiography and Interventions (SCAI) appointment in Orlando, Fla., in May.
COAST is congenital on CSI’s ORBIT II study, which was the aboriginal balloon advised to acquire acutely caked coronary lesions that are about afar from aloft analytic trials, but frequently apparent in real-world cases. COAST is a prospective, single-arm, multi-center, global, investigational abstraction advised to appraise the assurance and efficacy, as able-bodied as bread-and-er outcomes, of CSI’s new Diamondback 360® Coronary Alternate Atherectomy Arrangement (OAS) Micro Crown.
“Our aboriginal all-embracing coronary abstraction is advised to abutment the approval of our next-generation arrangement in the United States and Japan,” said Ward. “COAST aligns with our ORBIT II analytic acceding and abstraction design. We acquire that abstracts from this abstraction will highlight the abeyant allowances of our new Micro Acme and ultimately advice defended bartering approval in Japan, the world’s added bigger coronary market.”
The Micro Acme is CSI’s second-generation arrangement advised to facilitate stent charge in capacity with acutely caked coronary lesions who are adequate candidates for percutaneous transluminal coronary angioplasty (PTCA), or stenting. The Micro Acme is advised to anon appoint bound lesions with distal sanding while acceptance connected breeze during operation.
CSI intends to abide the abstracts from the COAST abstraction in its Shonin appliance planned for the summer of 2016 to abutment authoritative approval of the Diamondback 360 Coronary Alternate Atherectomy Arrangement (OAS) Micro Acme in Japan.
Budgetary 2016 Fourth-Quarter OutlookWard said, “Continued sales force adherence will accredit our 240 sales and analytic abutment professionals to accretion adeptness and added advance physician relationships. We ahead connected abundance increases in the fourth division and a acknowledgment to year-over-year acquirement advance in budgetary 2017. Acquirement growth, accumulated with our amount realignment, is accustomed to put us on a alleyway to advantage and absolute banknote flow.”
For the budgetary 2016 fourth division catastrophe June 30, 2016, CSI anticipates:
Appointment Alarm Today at 3:45 p.m. CT (4:45 p.m. ET)Cardiovascular Systems, Inc. will host a alive appointment alarm and webcast of its budgetary third-quarter after-effects today, May 4, 2016, at 3:45 p.m. CT (4:45 p.m. ET). To admission the call, punch (877) 201-0168 and admission the admission cardinal 95943490. Please punch in at atomic 10 account above-mentioned to the call. To acquire to the alive webcast, go to the broker area of the company’s website, www.csi360.com, and bang on the webcast icon.
For an audio epitomize of the appointment call, punch (855) 859-2056 and admission 95943490. The audio epitomize will be accessible alpha at 6:45 p.m. CT on Thursday, May 4, 2016, through 10:59 p.m. CT on Thursday, May 11, 2016.
Use of Non-GAAP Banking MeasuresTo supplement CSI’s circumscribed abridged banking statements able in accordance with U.S. about accustomed accounting attempt (GAAP), CSI uses assertive non-GAAP banking measures in this release. Reconciliations of the non-GAAP banking measures acclimated in this absolution to the best commensurable U.S. GAAP measures for the corresponding periods can be begin in tables after in this absolution anon afterward the circumscribed statements of operations. Non-GAAP banking measures acquire limitations as analytic accoutrement and should not be advised in a or as a acting for CSI’s banking after-effects able in accordance with GAAP.
About Borderline Avenue Ache (PAD)As abounding as 18 actor Americans, best over age 65, ache from PAD, which is acquired by the accession of applique in borderline arteries (commonly the abdomen or leg) abbreviation claret flow. Symptoms accommodate leg affliction back walking or at rest. Left untreated, PAD can advance to astringent pain, immobility, non-healing wounds and eventually limb amputation. With accident factors such as diabetes and blubber on the rise, the prevalence of PAD is growing at double-digit rates.
Millions of patients with PAD may account from analysis with alternate atherectomy utilizing the Stealth 360and Diamondback 360 Borderline Alternate Atherectomy Systems, minimally invasive catheter systems developed and bogus by CSI. These systems use a diamond-coated crown, absorbed to an orbiting shaft, which bank abroad applique while attention advantageous barge tissue — a analytic agency in preventing reoccurrences. Balloon angioplasty and stents acquire cogent shortcomings in alleviative hard, caked lesions. Stents are decumbent to fractures and aerial ceremony rates, and analysis of hard, caked lesions generally leads to barge accident and suboptimal results.
About Coronary Avenue Ache (CAD)CAD is a life-threatening action and a arch account of afterlife in men and women in the United States. CAD occurs back a blubbery absolute alleged applique builds up on the walls of arteries that accumulation claret to the heart. The applique accretion causes the arteries to amalgamate and attenuated (atherosclerosis), abbreviation claret flow. The accident of CAD increases if a actuality has one or added of the following: aerial claret pressure, aberrant cholesterol levels, diabetes, or ancestors history of aboriginal affection disease. According to the American Affection Association, 16.3 actor bodies in the United States acquire been diagnosed with CAD, the best accustomed anatomy of affection disease. Affection ache claims added than 600,000 lives in the United States anniversary year. According to estimates, cogent arterial calcium is present in about 40% of patients adeptness a percutaneous coronary action (PCI). Cogent calcium contributes to poor outcomes and college analysis costs in coronary interventions back adequate therapies are used, including a decidedly college accident of afterlife and aloft adverse cardiac contest (MACE).
About Cardiovascular Systems, Inc.Cardiovascular Systems, Inc., based in St. Paul, Minn., is a medical accessory aggregation focused on developing and commercializing avant-garde solutions for alleviative vascular and coronary disease. The company’s Alternate Atherectomy Systems amusement caked and fibrotic applique in arterial argosy throughout the leg and affection in a few account of analysis time, and abode abounding of the limitations associated with absolute surgical, catheter and pharmacological analysis alternatives. The U.S. FDA accepted 510(k) approval for the use of the Diamondback Alternate Atherectomy Arrangement in borderline arteries in August 2007. In October 2013, the aggregation accustomed FDA approval for the use of the Diamondback Alternate Atherectomy Arrangement in coronary arteries. The Stealth 360® Borderline Alternate Atherectomy Arrangement (OAS) accustomed CE Mark in October 2014. To date, about 249,000 of CSI’s accessories acquire been awash to arch institutions beyond the United States. For added information, appointment the company’s website at www.csi360.com.
Safe HarborCertain statements in this account absolution are advanced statements aural the acceptation of the Private Balance Litigation Reform Act of 1995 and are provided beneath the aegis of the safe anchorage for advanced statements provided by that Act. For example, statements in this columnist absolution apropos (i) our adjustment with the Department of Justice; (ii) our charge to acclimation acquirement advance with establishing a alleyway to approaching profitability; (iii) our goals of stabilizing the sales force and resuming after anniversary acquirement growth; (iv) added advance and accretion productivity; (v) the COAST trial, including the after-effects of the balloon and the timing of Shonin submission; (vi) the approval of our next-generation arrangement in the United States and Japan; (vii) connected sales force stability; (viii) our advancing connected abundance increases in the fourth division and a acknowledgment to year-over-year acquirement advance in budgetary 2017; (ix) our apprehension that acquirement advance and amount alteration will put us on a alleyway to advantage and absolute banknote flow; and (x) advancing revenue, gross profit, operating expenses, and net loss. These statements absorb risks and uncertainties that could account after-effects to alter materially from those projected, including, but not bound to, authoritative developments in the U.S. and adopted countries; FDA and agnate adopted clearances and approvals; approval of our articles for administration in adopted countries; approval of articles for acceding and the akin of reimbursement; assurance on bazaar growth; the acquaintance of physicians apropos the capability and believability of CSI’s products; the abhorrence of physicians, hospitals and added organizations to acquire new products; the abeyant for hasty delays in enrolling medical centers and patients for analytic trials; absolute analytic balloon and abstraction results; the appulse of aggressive articles and pricing; hasty developments affecting our estimates apropos expenses, approaching revenues and basic requirements; the adversity to auspiciously administer operating costs; our disability to sustain advance in our sales and business organization; our adeptness to administer agent turnover, advance and training; our adeptness to administer our sales force amplification and bifold authorization strategy; our absolute analysis and development efforts and needs; fluctuations in after-effects and costs based on new artefact introductions, sales mix, hasty assurance claims, and the timing of activity expenditures; our adeptness to defended financing; our adeptness to administer costs; accepted bread-and-er conditions; the adeptness of the aggregation to accommodate and accede aloft the absolute affidavit for adjustment of the Department of Justice amount and accomplishments of the cloister and added authoritative entities in affiliation therewith; and added factors abundant from time to time in CSI’s SEC reports, including its best contempo anniversary address on Anatomy 10-K and consecutive anniversary letters on Anatomy 10-Q. CSI encourages you to accede all of these risks, uncertainties and added factors anxiously in evaluating the advanced statements independent in this release. As a aftereffect of these matters, changes in facts, assumptions not actuality accomplished or added circumstances, CSI’s absolute after-effects may alter materially from the accustomed after-effects discussed in the advanced statements independent in this release. The advanced statements fabricated in this absolution are fabricated alone as of the date of this release, and CSI undertakes no obligation to amend them to reflect consecutive contest or circumstances.
Borderline ProductsThe Stealth 360® PAD Arrangement and Diamondback 360® PAD Arrangement are percutaneous alternate atherectomy systems adumbrated for use as analysis in patients with occlusive atheroscl ache in borderline arteries and stenotic absolute from bogus arteriovenous dialysis fistulae. The systems are contraindicated for use in coronary arteries, bypass grafts, stents or area array or dissections are present. Although the accident of adverse contest is rare, abeyant contest that can action with atherectomy include: pain, hypotension, CVA/TIA, death, dissection, perforation, distal emization, array formation, hematuria, brusque or astute barge closure, or arterial spasm.
Coronary ProductIndications: The Diamondback 360® Coronary Alternate Atherectomy Arrangement (OAS) is a percutaneous alternate atherectomy arrangement adumbrated to facilitate stent charge in patients with coronary avenue ache (CAD) who are adequate candidates for PTCA or stenting due to de novo, acutely caked coronary avenue lesions.
Contraindications: The OAS is contraindicated back the ViperWire adviser wire cannot canyon beyond the coronary bane or the ambition bane is aural a bypass affix or stent. The OAS is contraindicated back the accommodating is not an adapted applicant for bypass surgery, angioplasty, or atherectomy therapy, or has angiographic affirmation of thrombus, or has alone one accessible vessel, or has angiographic affirmation of cogent anatomization at the analysis armpit and for women who are abundant or children.
Warnings/Precautions: Assuming analysis in badly anfractuous argosy or bifurcations may aftereffect in barge damage; The OAS was alone evaluated in acutely caked lesions, A acting pacing advance may be all-important back alleviative lesions in the appropriate coronary and circumflex arteries; On-site surgical back should be included as a analytic consideration; Use in patients with an casting atom (EF) of beneath than 25% has not been evaluated. See the instructions for use afore assuming Diamondback 360Coronary OAS procedures for abundant advice apropos the procedure, indications, contraindications, warnings, precautions, and abeyant adverse events. For added advice alarm CSI at 1-877-274-0901 and/or argue CSI’s website at www.csi360.com.
Caution: Federal law (USA) restricts this accessory to auction by or on the adjustment of a physician.
Micro Acme OASCSI has commenced its COAST Investigational Accessory Exemption analytic balloon to appraise the assurance and capability of its new micro acme alternate technology in alleviative coronary arteries. This new arrangement is bound by federal law to investigational use and is currently not commercially accessible in the United States or Japan.
(1) A $99 accident on auctioning of accessories recorded in the third division of budgetary 2015 was reclassified from absorption and other, net to selling, accepted and authoritative costs in the fourth division of 2015.
Added artefact revenue(2)
Non-GAAP Banking MeasuresTo supplement CSI’s circumscribed abridged banking statements able in accordance with GAAP, CSI uses a non-GAAP banking admeasurement referred to as “Adjusted EBITDA” in this release.
Reconciliations of Adjusted EBITDA to the best commensurable U.S. GAAP admeasurement for the corresponding periods can be begin in the table on the aing page. In addition, an account of the address in which CSI’s administration uses Adjusted EBITDA to conduct and appraise its business, the bread-and-er actuality abaft management’s accommodation to use Adjusted EBITDA, the absolute affidavit why administration believes that Adjusted EBITDA provides advantageous advice to investors, the absolute limitations associated with the use of Adjusted EBITDA and the address in which administration compensates for those limitations is included afterward the adaptation table.
Add: Ancient costs (net of stock-based compensation)
Use and Bread-and-er Actuality of Non-GAAP Banking Measures Acclimated by CSI and Account of Such Non-GAAP Banking Measures to InvestorsCSI uses Adjusted EBITDA as a added admeasurement of accomplishment and believes this admeasurement facilitates operating accomplishment comparisons from aeon to aeon and aggregation to aggregation by factoring out abeyant differences acquired by abrasion and acquittal expense, non-cash accuse such as banal based compensation, and ancient costs. CSI’s administration uses Adjusted EBITDA to assay the basal trends in CSI’s business, appraise the accomplishment of CSI’s amount operations, authorize operational goals and forecasts that are acclimated to admeasure assets and appraise CSI’s accomplishment aeon over aeon and in affiliation to its competitors’ operating results. Additionally, CSI’s administration is evaluated on the base of Adjusted EBITDA back free accomplishment of their allurement advantage accomplishment targets.
CSI believes that presenting Adjusted EBITDA provides investors greater accuracy to the advice acclimated by CSI’s administration for its banking and operational controlling and allows investors to see CSI’s after-effects “through the eyes” of management. CSI additionally believes that accouterment this advice bigger enables CSI’s investors to accept CSI’s operating accomplishment and appraise the alignment acclimated by CSI’s administration to appraise and admeasurement such performance.
The afterward is an account of anniversary of the items that administration afar from Adjusted EBITDA and the affidavit for excluding anniversary of these alone items:
Absolute Limitations Associated with the Use of Non-GAAP Banking Measures and Address in which CSI Compensates for these LimitationsNon-GAAP banking measures acquire limitations as analytic accoutrement and should not be advised in a or as a acting for CSI’s banking after-effects able in accordance with GAAP. Some of the limitations associated with CSI’s use of these non-GAAP banking measures are:
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