-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CzAMvnI41xLYZKxwIeQllO/Fu3mmj9gg425OY3kzGCWmkIhsbDMbUqibWEpcE8jj 6b0UKQsKkH1TyYDOYq0evg== 0001104659-06-001620.txt : 20060111 0001104659-06-001620.hdr.sgml : 20060111 20060111111501 ACCESSION NUMBER: 0001104659-06-001620 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060111 DATE AS OF CHANGE: 20060111 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IMMUCOR INC CENTRAL INDEX KEY: 0000736822 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 222408354 STATE OF INCORPORATION: GA FISCAL YEAR END: 0531 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14820 FILM NUMBER: 06523944 BUSINESS ADDRESS: STREET 1: 3130 GATWAY STREET 2: PO BOX 5625 CITY: NORCROSS STATE: GA ZIP: 30091 BUSINESS PHONE: 770 441 2051 MAIL ADDRESS: STREET 1: 3130 GATEWAY DR STREET 2: P O BOX 5625 CITY: NORCROSS STATE: GA ZIP: 30091-5625 8-K 1 a06-1572_18k.htm CURRENT REPORT OF MATERIAL EVENTS OR CORPORATE CHANGES

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT
Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported):  January 5, 2006

 

IMMUCOR, INC.

(Exact name of registrant as specified in its charter)

 

Georgia

 

0-14820

 

22-2408354

(State or other jurisdiction

 

(Commission

 

(IRS Employer

of incorporation)

 

File Number)

 

Identification No.)

 

 

 

 

 

3130 Gateway Drive   P.O. Box 5625   Norcross, Georgia

 

30091-5625

(Address of principal executive offices)

 

(Zip Code)

 

Registrant’s telephone number, including area code, is (770) 441-2051

 

Not applicable

(Former name or former address,
if changed since last report.)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions.

 

o  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

o  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 



 

Item 2.02.  Results of Operations and Financial Condition

 

Immucor, Inc. (the “Company’) issued a press release on January 5, 2006 announcing the Company’s earnings and certain other results of operations for the fiscal second quarter of the year ending May 31, 2006 and discussing the Company’s outlook for the remainder of fiscal year 2006.  This press release is furnished with this Current Report as Exhibit 99.1.  Edward L. Gallup, the Company’s Chairman and Chief Executive Officer; Dr. Gioacchino De Chirico, the Company’s President, and Patrick D. Waddy, the Company’s Chief Financial Officer and Secretary, hosted a conference call on Friday, January 6, 2006 to review the contents of the press release and to answer questions from investors.  The transcript of this conference call is furnished with this Current Report as Exhibit 99.2.

 

Item 9.01.  Financial Statements and Exhibits

 

(d)  Exhibits

 

EXHIBIT NUMBER

 

DESCRIPTION

 

 

 

99.1

 

Press Release dated January 5, 2006.

99.2

 

Transcript of Conference Call held January 6, 2006.

 

2



 

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.

 

 

 

IMMUCOR, INC.

 

 

 

 

 

 

Date: January 11, 2006

By:

/s/ Patrick D. Waddy

 

 

 

Patrick D. Waddy

 

 

Chief Financial Officer and Secretary

 

3



 

EXHIBIT INTEX

 

EXHIBIT NO.

 

DESCRIPTION

 

 

 

99.1

 

Press Release dated January 5, 2006.

99.2

 

Transcript of Conference Call held January 6, 2006.

 

4


EX-99.1 2 a06-1572_1ex99d1.htm PRESS RELEASE DATED JANUARY 5, 2006

Exhibit 99.1

 

Press Release dated January 5, 2006.

 

 

SHAREHOLDER NEWS

FOR IMMEDIATE RELEASE

CONTACT: Edward Gallup

770-441-2051

 

 

IMMUCOR ANNOUNCES RECORD SECOND QUARTER
REVENUES AND CONFIRMS FULL YEAR GUIDANCE

 

 

NORCROSS, GA. (January 5, 2006) – Immucor, Inc. (Nasdaq/NM: BLUD), the global leader in providing automated instrument-reagent systems to the blood transfusion industry, today reported financial results for the fiscal second quarter ended November 30, 2005.

 

Revenues for the fiscal second quarter were a record $44.0 million, up 34.9% from $32.6 million in the same period last year. The $11.4 million increase was primarily the result of price increases. Gross margin improved during the quarter to a record 64.8% up from 56.1% in the prior year quarter.

 

Net income for the second quarter was $8.1 million, up 91.3% from $4.2 million for the same quarter last year. Diluted earnings per share totaled $0.17 on 47.6 million weighted average shares outstanding, up from $0.09 on 47.3 million weighted average shares outstanding for the same period last year. The previously announced decision to consolidate our manufacturing operations resulted in a restructuring charge of $2.5 million in the quarter. On an after tax basis this charge reduced net income by approximately $1.6 million. Net income for the second quarter was adversely impacted by an increase of $0.4 million in audit and Sarbanes-Oxley compliance costs and by an increase of $0.1 million in legal fees as compared to the same period last year.

 

Sales of instruments were $3.0 million in the second quarter of fiscal 2006, a decrease from $3.7 million in the fiscal 2005 second quarter. Most instrument sales in the United States are now being recognized over the life of the underlying reagent contract, which is normally 5 years. In the quarter ended November 30, 2005 approximately $1.4 million of instrument sales were deferred in this manner. As of November 30, 2005, deferred instrument revenues, including deferred service revenues, totaled $11.4 million.

 

Reagent gross margin grew to 70.9% during the second quarter of fiscal 2006 compared to 61.4% in the same period last year.  The previously mentioned price increases and improved manufacturing efficiencies were responsible for this improvement.

 



 

Research and development expenses were $1.2 million in the second quarter, up 4.7% from the prior year quarter.  Spending on the development of the Galileo EchoTM (formerly referred to as the “G3”) – our new third generation instrument targeted for the small to medium-sized hospital market – was $217 thousand in the second quarter, a decrease of $204 thousand from the same period last year.

 

“We continue to be very proud of the job our employees are doing in reducing manufacturing costs while we recorded record revenues for the eighth consecutive quarter,” said Edward L. Gallup, Chairman and Chief Executive Officer.  “Based on the outlook for the balance of fiscal 2006 we are confirming our earlier guidance for fiscal 2006 for annual revenues of $180.0 million to $190.0 million and earnings per diluted share of between $0.76 and $0.85.”

 

Dr. Gioacchino De Chirico, President said, “We are very excited about our continuing success in lowering costs and increasing margins. Our second quarter gross margin of 64.8% was a record for the Company and we remain focused on increasing our gross margin to over 70% within three years.

 

Commenting further, Dr. De Chirico stated, “Based on the very positive customer reaction to our planned launch of the EchoTM in the United States in the fall of 2006 we believe we will achieve market share gain and revenue growth through continued Galileo placements and the launch of the EchoTM. As of November 30, 2005 the Company had received purchase orders for a total of 298 Galileo instruments worldwide (an increase of 23 in the quarter): 206 in Europe, 90 in North America and 2 in Japan.”

 

Commenting further, Dr. De Chirico stated, “As of November 30, 2005, 239 Galileo instruments were generating reagent revenues, an increase of 26 in the quarter. We continue to work with our Galileo customers to reduce the length of time it takes them to validate these instruments.”

 

Selected Highlights

 

-Sales of traditional reagent products, i.e., products not utilizing the Company’s patented Capture technology, increased $10.0 million, or 46.2%, from $21.6 million in the second quarter of 2005 to $31.6 million in the second quarter of 2006. Sales of Capture® products increased approximately $1.8 million to $8.4 million, a 26.8% increase over the prior year quarter. Human collagen sales increased approximately $0.4 million to $1.1 million, a 50.0% increase over the prior year quarter.

 

-For the current fiscal year-to-date, sales of traditional reagent products were $62.9 million compared with $43.7 million in the prior year period, an increase of 44.1%. Capture product sales increased approximately $3.2 million to $16.3 million, an increase of 24.8% over the comparable 2005 period. Human collagen sales were $2.2 million for the six months ended November 30, 2005 and increase of $0.6 million over the prior year period.

 



 

-The gross margin on traditional reagents was 68.8% for the current quarter, compared with 56.7% in the prior year quarter. The increase in gross margin is primarily due to price increases in the United States.  The gross margin on Capture products was 78.6% for the current quarter, compared with 76.7% in the prior year quarter.  The gross margin on human collagen sales was 31.1% during the quarter, compared with 25.4% in the prior year quarter.

 

-Sales of instruments were $3.0 million in the second quarter of 2006 compared to $3.7 million in the second quarter of 2005. The gross margin on instruments, including the impact of the cost of providing service, was 0.2% for the current quarter, compared to 22.1% for the same quarter last year. Instrument gross margin in the current quarter was adversely impacted as $1.4 million of revenues from instrument sales were deferred in the quarter while the entire cost of sales of $0.7 million on those instrument sales was expensed in the quarter.

 

 -The effect on revenues of the change in the Euro exchange rate was a decrease of $461 thousand for the second quarter of 2006 as compared with the prior year quarter.  The effect on net income of the change in the Euro exchange rate was a decrease of $27 thousand in the current quarter ended November 30, 2005.

 

-Distribution expenses decreased by $22 thousand in the second quarter and selling and marketing expenses increased by $1.0 million, as compared to the prior year quarter. Our new Japanese joint venture was responsible for $0.9 million of the increase in selling and marketing expenses. General and administrative expenses increased by $1.1 million for the second quarter of 2006 as compared to the prior year quarter, partly due to higher legal and audit fees associated with the finalization of the internal investigation relating to events in Italy and additional audit fees associated with the additional procedures required to complete the Annual Report on Form
10-K.

 

-Operations continue to generate strong cash flow. Cash, cash equivalents and marketable securities totaled $36.4 million at the end of the current quarter compared to $18.1 million at the end of the prior year quarter and $39.1 million at May 31, 2005. During the quarter the Company completely paid off its long term debt with SunTrust of $5.0 million and repurchased 642,600 shares of its Common Stock at a total cost of $14.9 million under its stock repurchase program.

 

Immucor, Inc. will host a conference call January 6, 2006 at 8:30 a.m. (EST) to review the results.  Investors are invited to participate in this conference call with Edward L. Gallup, Chairman and Chief Executive Officer; Dr. Gioacchino De Chirico, President; and Patrick Waddy, Chief Financial Officer. The call will focus on the results for the second quarter, general business trends, and the Company’s outlook for fiscal 2006.  This earnings release will be posted on Immucor’s website, as well as any financial information that may be discussed by Messrs. Gallup, De Chirico or Waddy during this call that is not contained in the earnings release.  Both this earnings release and the additional financial information, if any, will be posted as soon as practicable after the call on the investor news section of Immucor’s website.  To access this information once posted, go to Immucor’s website at www.immucor.com and click on “About Us – Press Releases.”

 



 

To participate in the telephone conference call, dial 1-888-889-2036, pass code BLUD. Replays of the conference call will be available for one week beginning at 12:00 PM on January 6, 2006 by calling 1-800-284-5340.  Beginning January 13, 2006, audio of the conference call or a transcript of the audio will be available on the “About Us – Press Releases” page of the Immucor website.

 

Founded in 1982, Immucor manufactures and sells a complete line of reagents and systems used by hospitals, reference laboratories and donor centers to detect and identify certain properties of the cell and serum components of blood prior to transfusion. Immucor markets a complete family of automated instrumentation for all of its market segments.

 

For more information on Immucor, please visit our website at www.immucor.com.

 

Statements contained in this press release that are not statements of historical fact are “forward-looking statements” as that term is defined under federal securities laws, including, without limitation, all statements concerning Immucor’s expectations, beliefs, intentions or strategies for the future.  Forward-looking statements may be identified by words such as “plans,” “expects,” “believes,” “anticipates,” “estimates,” “projects,” “will,” “should” and other words of similar meaning used in conjunction with, among other things, discussions of future operations, financial performance, product development and new product launches, FDA and other regulatory applications and approvals, market position and expenditures.  Factors that could cause actual results to differ materially from those expressed in any forward-looking statement include the following: the decision of customers to defer capital spending, the inability of customers to efficiently integrate our instruments into their blood banking operations, increased competition in the sale of instruments and reagents, product development or regulatory obstacles, changes in interest rates, fluctuations in foreign currency conversion rates, changes in demand for the Company’s human collagen product, the outcome of any legal claims known or unknown, delays in regulatory approvals required to move Houston manufacturing to another Company facility; other currently unforeseen events that could delay the move; higher than expected closure costs; higher than expected manufacturing consolidation costs, the unexpected application of different accounting rules, and general economic conditions.  Further risks are detailed in the Company’s filings with the Securities and Exchange Commission.  Investors are cautioned not to place undue reliance on any forward-looking statements.  Immucor assumes no obligation to update any forward-looking statements.

 



 

IMMUCOR, INC.

Condensed Consolidated Statements of Income

(Unaudited)

 

 

 

For the Three Months Ended

 

For the Six Months Ended

 

 

 

November 30,
2005

 

November 30,
2004

 

November 30,
2005

 

November 30,
2004

 

 

 

 

 

 

 

 

 

 

 

Net sales

 

$

44,024,845

 

$

32,640,218

 

$

86,459,338

 

$

64,742,429

 

Cost of sales

 

15,483,662

 

14,319,019

 

31,222,852

 

28,108,758

 

Gross profit

 

28,541,183

 

18,321,199

 

55,236,486

 

36,633,671

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

1,207,601

 

1,153,920

 

2,463,032

 

2,242,726

 

Selling and marketing

 

5,194,913

 

4,210,898

 

10,409,574

 

8,277,284

 

Distribution

 

1,930,917

 

1,952,845

 

3,782,237

 

3,891,862

 

General and administrative

 

4,887,864

 

3,749,230

 

10,710,120

 

6,766,162

 

Restructuring expenses

 

2,456,766

 

0

 

2,456,766

 

0

 

Amortization expense and other

 

96,879

 

606,299

 

167,376

 

702,362

 

Total operating expenses

 

15,774,940

 

11,673,192

 

29,989,105

 

21,880,396

 

 

 

 

 

 

 

 

 

 

 

Income from operations

 

12,766,243

 

6,648,007

 

25,247,381

 

14,753,275

 

 

 

 

 

 

 

 

 

 

 

Interest income

 

232,558

 

111,761

 

415,533

 

248,388

 

Interest expense

 

(182,871

)

(219,055

)

(341,854

)

(325,387

)

Other income (loss)

 

(152,550

)

575,919

 

(70,123

)

280,715

 

Total other

 

(102,863

)

468,625

 

3,556

 

203,716

 

 

 

 

 

 

 

 

 

 

 

Income before income taxes

 

12,663,380

 

7,116,632

 

25,250,937

 

14,956,991

 

 

 

 

 

 

 

 

 

 

 

Income taxes

 

4,608,710

 

2,907,133

 

9,190,591

 

5,798,539

 

 

 

 

 

 

 

 

 

 

 

Net income

 

$

8,054,670

 

$

4,209,499

 

$

16,060,346

 

$

9,158,452

 

 

 

 

 

 

 

 

 

 

 

Earnings per share:

 

 

 

 

 

 

 

 

 

Per common share

 

$

0.18

 

$

0.09

 

$

0.35

 

$

0.20

 

Per common share - assuming dilution

 

$

0.17

 

$

0.09

 

$

0.34

 

$

0.19

 

 

 

 

 

 

 

 

 

 

 

Weighted average shares outstanding:

 

 

 

 

 

 

 

 

 

Basic

 

45,521,206

 

44,863,430

 

45,531,525

 

44,948,897

 

Diluted

 

47,649,446

 

47,343,340

 

47,711,855

 

47,408,969

 

 

IMMUCOR, INC.

Selected Consolidated Balance Sheet Items

 

 

 

November 30, 2005

 

May 31, 2005

 

 

 

(Unaudited)

 

 

 

 

 

 

 

 

 

Cash

 

$

33,423,037

 

$

37,107,539

 

Accounts receivable – trade

 

36,921,671

 

34,629,624

 

Inventory

 

19,825,463

 

21,836,412

 

Total current assets

 

97,572,480

 

100,882,474

 

Property and equipment – net

 

22,055,704

 

23,034,727

 

Total assets

 

161,950,525

 

157,613,233

 

 

 

 

 

 

 

Current portion – long-term debt, capital leases and lines of credit

 

41,678

 

4,617,409

 

Accounts payable

 

11,091,013

 

8,027,562

 

Total current liabilities

 

28,080,196

 

29,936,547

 

Long-term debt, capital leases and lines of credit

 

55,892

 

2,991,118

 

Other liabilities

 

14,986,400

 

7,253,217

 

Shareholders’ equity

 

118,828,037

 

117,432,351

 

 


EX-99.2 3 a06-1572_1ex99d2.htm TRANSCRIPT OF CONFERENCE CALL HELD JANUARY 6, 2006

Exhibit 99.2

 

Transcript of Conference Call held January 6, 2006.

 

IMMUCOR

 

January 6, 2006

8:30 a.m. EST

 

Coordinator

 

Good day, ladies and gentlemen. Thank you for standing by and welcome to the Immucor, Incorporated conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded.

 

 

 

C. Vinson

 

Certain statements on this conference call constitute forward-looking statements, and actual results and events could differ materially; specifically, the statements regarding earnings estimates and Galileo statements are forward-looking statements and were developed based on current estimates and numerous assumptions. These estimates and assumptions reflect subjective judgments concerning future events and circumstances and may be incomplete or incorrect; and unanticipated events and circumstances may occur causing these estimates or assumptions to be wrong. The company does not intend to update or

 

1



 

 

 

revise its projections unless required to do so by the Federal Securities laws. For a detailed discussion of factors that could cause actual results to vary from these forward-looking statements, please refer to the company’s most recent filings with the SEC, including our annual report on Form 10-K and our most recent Form 10-Q.

 

 

 

Coordinator

 

I would now like to introduce your host for today’s conference, Mr. Ed Gallup, Chairman. Mr. Gallup, you may begin.

 

 

 

E. Gallup

 

Thank you and good morning. Thanks for joining us to discuss our second quarter fiscal year ‘06 results. Participating with me on this call are Dr. Nino De Chirico, our President, and Patrick Waddy, our Vice President and Chief Financial Officer.

 

 

 

 

 

We are very pleased with our record revenues of $44 million for the quarter. This represents eight consecutive quarters of record revenues by the Company. In addition to this, we achieved a new gross margin high of 64.8%. As you know, we took a one-time charge of $2.5 million in the quarter related to the closing of our Houston facility. Without this charge, which was $0.03 per share, we would have recorded record net income and record earnings per share as well.

 

2



 

 

 

We believe that in the past, we have created confusion by discussing too many factors regarding the Galileo, and have determined that the most productive way to handle this issue in the future is to discuss orders received and the number of instruments that are live, which of course means generating reagent revenue.

 

 

 

 

 

During the quarter, we received orders for 23 Galileo; 15 of these were in North America and eight came from Europe. As many of you know, this instrument business continues to be very lumpy on a monthly and a quarterly basis. For example, during the last quarter, North American orders were ten in September, none in October, and five in November. December orders were 11, and we expect to hit our original guidance of 70 to 90 orders for North America during fiscal year ‘06. This expectation is based on the 34 orders, which are in-house at the end of December, and the closing of one of our three large potential customers, where the delta between 70 and 90 depends on which of the three customers.

 

 

 

 

 

Overall, our European business is weaker than expected, but we believe the Echo can have a strong impact on this market. There were 15 Galileo orders in Europe in the first two quarters. These two quarters are usually

 

3



 

 

 

weak in that area, and we now expect 40 to 50 orders by the end of the fiscal year.

 

 

 

 

 

An additional 26 customers went live in the quarter as compared to 22 in the first quarter. We continue to make progress in this area, and presently have 239 customers who are live.

 

 

 

 

 

We are also very pleased that the average annual reagent trail has grown from $120,000 per instrument reported last quarter to approximately $140,000 for this quarter. This of course is a result of customers adding additional tests once the instruments are live.

 

 

 

 

 

As stated in the press release, we are reiterating our fiscal ‘06 guidance for revenues in the range of $180 million to $190 million, gross margins of 65% to 66% and earnings per share between $0.76 and $0.85.

 

 

 

 

 

Regarding our CFO position, we did a very thorough outside search and unanimously agreed that Patrick was the best individual for the job. I look forward to traveling with Patrick and meeting with many of you in the near future.

 

4



 

 

 

We are also very pleased with the transition of our audit business to Grant Thornton.

 

 

 

 

 

The Galileo Echo remains on track for a European launch in the summer followed by a U.S. launch this fall. We continue to be very impressed by the enthusiasm our customers have shown for the Echo, and look forward to addressing this potential market of approximately 6,000 accounts.

 

 

 

 

 

Finally, we purchased 642,000 shares of our common stock last quarter and continue to do so on an opportunistic basis.

 

 

 

 

 

At this point, I will return the call to the operator to begin our Q&A.

 

 

 

Coordinator

 

Thank you. Steve Hamill with Piper Jaffrey, you may begin.

 

 

 

S. Hamill

 

Good morning. I was wondering, first, if you could talk a little bit about Europe again. I know it got raised last quarter, but realistically are you seeing any progress in Germany or in any of the other less penetrated markets for Galileo right now?

 

5



 

E. Gallup

 

I think, Steve, that yes; we are seeing a little bit. We sold three instruments in Munich relatively recently, and that gives us a little bit better feeling as far as money being available to purchase instruments. But we’re not seeing a dramatic change.

 

 

 

S. Hamill

 

So where do you see the opportunity? You have about 15 placed so far in Europe this year. To get to 40 to 50, obviously you need some acceleration in the second half of the fiscal year. What parts of the continent do you think you might have the best opportunity to hit those numbers?

 

 

 

G. DeChirico

 

This is Nino. The summer time in Europe is usually very slow time for instruments. We believe that the 40 to 50 instruments are achievable in Europe. Of the countries who would contribute, Italy, Germany, France and Spain and Portugal will contribute to this to achieve this number. We have a forecast and we think we can make it.

 

 

 

S. Hamill

 

Then with regard to the operating profitability, which was strong and seems to have been partly driven by lower G&A expenses, which was a bit of a surprise. I would have expected to see some hefty professional fees

 

6



 

 

 

this quarter. Should that continue to improve now? Is the worst behind us?

 

 

 

G. DeChirico

 

Patrick?

 

 

 

P. Waddy

 

Steve, audit and SOX were approximately $800,000 in the quarter, legal $900,000. Audit and SOX going forward for the last two quarters of the year will probably be about $600,000 per quarter. Legal we are estimating about $500,000.

 

 

 

G. DeChirico

 

Yes, we are very optimistic on this.

 

 

 

S. Hamill

 

And then last, in terms of the makes and the metrics you gave on the number of Galileo’s that have gone live, you mentioned it was 26 worldwide. Can you tell us how many are live now in terms of by geography?

 

 

 

G. DeChirico

 

I have this number for you. Oh, by geographies and totals?

 

 

 

S. Hamill

 

Correct. Yes, the installed base.

 

7



 

G. DeChirico

 

Then we have 35 in Belgium and France, three in Canada, 73 in Germany. Germany 73 means that Germany in distribution, we include that as Germany, all the distribution network: 55 Italy, seven Portugal, 19 Spain, two Japan, 45 United States.

 

 

 

S. Hamill

 

 

 

 

 

All

 

Thank you.

 

 

 

Coordinator

 

At this time How many in the U.S.?

 

 

 

G. DeChirico

 

Forty-five.

 

 

 

E. Gallup

 

Steve, just to clear up, as many of you are probably aware, out of Germany we ship instruments to Eastern Europe, for example. We ship instruments I believe to the U.K. out of Germany and I think we’ve even shipped Australia out of Germany. So that is why you see the distribution number a little different than the actual placements in Germany.

 

 

 

S. Hamill

 

Thank you. I will jump back in queue.

 

 

 

Coordinator

 

Bill Quirk with RBC Capital Markets, you may ask your question.

 

8



 

B. Quirk

 

Thank you. Just thinking about the back half of fiscal 2006 would suggest a pretty steep ramp in reagent revenue. You just gave us some incremental information on the number of instruments up and running, but presumably you are expecting a pretty substantial improvement here. Are we on the cusp of a large number of instruments rolling over? In terms of validation, are you planning some reagent price increases, again specifically on the traditional side? Can you help us think about that a little?

 

 

 

G. DeChirico

 

For sure Galileo going live is a key point. An interesting statistic is that to date we have an automatic 34, 100% competitive takeaway. But out of 34, only 14 are live. That means that we have 20, 100% competitive takeaway that are not live yet. As soon as there is a get in there would be incremental revenue for that. I think Galileo live is a key point.

 

 

 

B. Quirk

 

Perhaps you could remind us again, how many on average, how many days are the instruments that haven’t been validated sitting out there? I think you gave us a metric last quarter. Maybe you could just refresh our memories?

 

9



 

G. DeChirico

 

Yes, I will give you the last statistic we have. It is 103 days for the instrument that went live then we keep going at the same number. The instruments not live today are 158 days. The reason this is a little more than last time is because there are something like eight instruments that are still installed now more than 300 days and they are not live yet. That is only eight instruments that make the statistics worse. But the statistic on going live on the instrument that went live, the 45 we are talking about, is 103 days.

 

 

 

B. Quirk

 

With respect to the more recent placements where you set up essentially an automatic reagent agreement, are those coming live, as you expected? And then secondly, and I will jump back into the queue after this, what type of intelligence can you give us on some of these older instruments that for whatever reason just persist in sitting in the corner instead of getting validated?

 

 

 

G. DeChirico

 

Those ones that are sitting in the corner, they are all related to interface issue. The issue that we discussed all along, that they are waiting for their IS department, the vendor, to interface the instrument. The new instrument, we see an improvement in terms of length. But this group of instruments that are still waiting for interfacing, they are still waiting.

 

10



 

B. Quirk

 

That would at least sound to mean Nino that is going to be kind of picking these off one off at a time. Essentially it is dependent on the hospital, it is not something from Immucor’s standpoint such as being able to interface the new Misys system, for example?

 

 

 

G. DeChirico

 

Yes, it would be one at a time and it would be not dependent on Immucor.

 

 

 

B. Quirk

 

Understood. I will jump back in the queue. Thanks, guys.

 

 

 

Coordinator

 

Sean McKenna with Global Crown Capital, you may ask your question.

 

 

 

S. McKenna

 

Hello, guys. Good morning. I just wanted to clarify on actually some of the previous questions that have been asked. You have 45 Galileo customers live in the U.S.?

 

 

 

G. DeChirico

 

Yes.

 

 

 

S. McKenna

 

And the average go live time is how many days — 103?

 

 

 

G. DeChirico

 

One hundred and three days.

 

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S. McKenna

 

103 and then overall, what was the 158 number that you gave?

 

 

 

G. DeChirico

 

If you group the customers that are installed, that are not live, we average 158 days. What this means is that we have a group of customers that average 158 days are not live. But inside of this group, like I said before, there are eight customers that make this statistic look bad.

 

 

 

S. McKenna

 

So 158 instruments not live.

 

 

 

G. DeChirico

 

No, 158 days.

 

 

 

S. McKenna

 

And then secondly, Patrick, I was wondering if you could tell me in the U.S. and Europe how many of those instruments, I know you guys have talked about how many orders you had, but how many instruments did you actually expense in the quarter in the U.S. versus Europe if you have that?

 

 

 

P. Waddy

 

We recognize nine in the United States.

 

 

 

S. McKenna

 

And then in Europe?

 

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P. Waddy

 

It would be the eight.

 

 

 

S. McKenna

 

And then one more before I jump back in the queue. I was wondering if you guys could talk about your margin expectations. Are they still the same? Do you feel like you’re being conservative? It looks like to me, what I would expect in Q3 is kind of a pretty big uptick in reagent revenues, actually sort of based on the go live times that you had reported before. Again, I think someone had mentioned this, a lot of instruments rolling over. Could you talk about margins a little bit?

 

 

 

G. DeChirico

 

Well, we feel very comfortable with our guidance of 65% and 66% for the year. That means it is going to improve in the second half of the year.

 

 

 

S. McKenna

 

Okay. Thanks a lot, guys.

 

 

 

Coordinator

 

David Zimbalist with Natexis Bleichroeder, you may ask your question.

 

 

 

D. Zimbalist

 

Thank you. I apologize if I am repeating questions that were asked before. I got on the call a little late. Could you talk a little bit about your G&A? It was down sequentially for the first time in a long time. What were the

 

13



 

 

 

components of the decline and how sustainable is this $4.8 million as base?

 

 

 

E. Gallup

 

We did go over that, but Patrick you want to just hit it again briefly?

 

 

 

P. Waddy

 

Audit and SOX in Q1 were about $1.7 million, in Q2 they were closer to $0.8 million, a decline of $900,000. Legal was actually up about $100,000 from $800,000 in Q1 to $900,000 in Q2. So we had a total of about $1.7 million in Q2. We are looking at a decline of $500,000 a quarter, roughly for the next two quarters from that number.

 

 

 

D. Zimbalist

 

Each quarter or like a—

 

 

P. Waddy

 

Each quarter. So it runs roughly $1.1 million, $1.2 million per quarter.

 

 

 

D. Zimbalist

 

The gross margins on the traditional reagents and the capture reagents, if I calculated correctly, were a little bit down sequentially. Can you talk a little bit about that and what maybe might turn those back upwards?

 

 

 

G. DeChirico

 

Yes, the margin mostly on the Capture is linked to the manufacturing volume. Then it fluctuates up and down because of our manufacturing

 

14



 

 

 

volume. For the reagents, we had for the second quarter a decrease of $250,000 of profit because of our buy-back inventory from Kainos. Then if you add up to this one time $250,000 of reagent profit, our profit in the quarter was very good.

 

 

 

D. Zimbalist

 

That $250,000 was reagent that you bought back in the last quarter that then went back out this quarter. Is that the way to think of it?

 

 

 

P. Waddy

 

No, they were bought in Q2 and it is simply the inter-company profit that was realized on those reagents. It is a one-time item. It will only change in the future if inventory in Japan goes up or down, and the impact was probably about 60 basis points.

 

 

 

D. Zimbalist

 

Thank you very much.

 

 

 

Coordinator

 

Robert Flan with Guardian Life, you may ask your question.

 

 

 

R. Flan

 

Good morning. I just had a couple of questions. The first is a follow-up on an earlier question on Europe, because you are keeping the guidance for instrument orders sustained, but you did say that Europe was weaker than expected. So even if you were in a slow period, it was slower than you

 

15



 

 

 

thought, just to reiterate again why you think that basically the second half may be in that case maybe stronger than you originally had thought? That is the first question. You can answer that first.

 

 

 

E. Gallup

 

I think there may be a little confusion. Last quarter on the conference call the number came up what was the guidance for Galileo orders and I replied 50 to 60, and that would be a stretch. That is why we are saying today 40 to 50. So from that standpoint, the business is a little weaker. But with only 15 Galileo orders in the first two quarters for Europe, which is about as expected simply because, as Nino mentioned, the summer months in the business are lumpy. But we do believe the 40 to 50 is achievable.

 

 

 

R. Flan

 

That verifies it. Thanks. The next question—

 

 

 

G. DeChirico

 

Sorry, let me add one thing to clarify here. With the 40 or 50, Europe will be 250 instruments or more placed of Galileo in a potential market where we always said of 600 to 700. That means that we reached a large market share in Europe with the Galileo. It is just a life cycle of this instrument.

 

16



 

R. Flan

 

My second question, and then I will have one more after that, has to do with your expectations for launching of the Echo’s in Europe and the U.S. Could you just talk a little bit about what are the data points that give you the confidence that regulatory authorities are going to approve the devices on the schedule you expect?

 

 

 

E. Gallup

 

Primarily, the Galileo was approved in 83 days. Cleared, I think is the better word, by the FDA in 83 days. The reagents on the Echo, with the exception of two new reagents, are identical to Galileo reagents. So we would expect it would go in on a 510-K and it will be approved within the 90-day targeted time by the FDA.

 

 

 

R. Flan

 

What about in Europe?

 

 

 

G. DeChirico

 

The instruments are, for the CE Mark purpose, considered self-declared. What that means is that you have to just generate data and have in your file. You do not need approval for the instrument. The timing in Europe is mostly depending on the reagents we were talking about. The instrument is a self-declared item.

 

17



 

R. Flan

 

You have all that and everything, so you have the data on the instrument already.

 

 

 

G. DeChirico

 

We are, as we speak, generating data.

 

 

 

R. Flan

 

The last question has to do with Japan. It is kind of a two-parter. One, since you didn’t sell any Galileo’s this quarter and if you could talk about why, maybe I am just missing something? Also if you could update me on what has happened with the distribution change and if there are any hang-ups there or how smooth it’s going?

 

 

 

G. DeChirico

 

I think we talked about this is in the last quarter and the situation has not changed other than we realized when we went there our management team, Kaz Ota, Hirosho Hoketsu and Suzuki, they realized that the sales force from our former distributor, Kainos, was really not efficient and effective. We are now changing the entire sales force and we are hiring as we speak new people, mostly from competitors that are very well experienced in the blood bank market. We will see improvement of this situation in the next fiscal year.

 

 

 

R. Flan

 

How far along on the hiring? You are almost done, half way through?

 

18



 

G. DeChirico

 

One-third to one-half. Japanese search out system is more complex than ours, but with these three men I mentioned before they are very well known from the people in the market, and I think we hope to finalize to hire all the new people by the end of this fiscal year.

 

 

 

R. Flan

 

Thank you. I am done.

 

 

 

Coordinator

 

Dan McCall, a private investor. Sir, you may ask your question.

 

 

 

D. McCall

 

Thank you. The increase in revenue over the last year was primarily the result of price increases. At the same time, over the last year there has been a significant increase in the number of Galileo instruments that are generating revenue. Does this mean that the Galileo instruments added over the year are not creating additional volume; just price increases?

 

 

 

G. DeChirico

 

No, there is volume. Of course, the reagents are the same, the manual reagents and the Galileo reagents are the same, but we have also increased in volume. But like I said before, the big increase in volume we are expecting is from 100% competitive takeaway. And like I said before out of the 34 in sold orders of competitive takeaway, only 14 are live today.

 

19



 

 

 

We will see an improvement going forward when the other 20 or more will go live.

 

 

 

E. Gallup

 

It is more difficult, it seems to us and it is certainly validated by the numbers, for a competitive takeaway to validate the instrument than an Immucor customer to validate the instrument.

 

 

 

G. DeChirico

 

Yes, because a competitive take away, they have authority to buy the instrument but also to validate all the reagents, because it is a completely new system for them.

 

 

 

D. McCall

 

Yes, but still, if all the revenue increase is as a result of price increases, doesn’t that mean that there has not been any volume increase?

 

 

 

P Waddy

 

No, the numbers were also impacted by a $500,000 decline in sales due to the Euro weakening.

 

 

 

G. DeChirico

 

And that is made up by the volume. We see a volume increase for sure.

 

 

 

D. McCall

 

Thank you.

 

20



 

G. DeChirico

 

You are welcome.

 

 

 

Coordinator

 

Bill Quirk with RBC Capital Markets, you may ask your question.

 

 

 

B. Quirk

 

Yes, just wanted to ask a couple of follow-ups here. With respect to the one of the three large customers that you talked about earlier, Ed, how much of a swing factor with respect to the top line guidance are, I guess specifically the one which sounds I guess like it is being relatively close to being landed, vis-à-vis the other two? In other words, if you land all three are we going to close to the 190, if we land just the one we’re going to be out 180? Maybe you could just help us think about that a little bit.

 

 

 

E. Gallup

 

If we landed all three we would be above 90. We’re making progress with all three, but I think the likelihood of closing all three is very slim. Two of the three will certainly put us between the 70 and 90 range, one of the three, depending on who it is, could put us at the high end.

 

 

 

G. DeChirico

 

Bill, I think you were asking also the question in terms of revenue. In terms of revenue, I don’t think that this will impact this fiscal year. It is not in our numbers. In other words, assuming we get the purchase order

 

21



 

 

 

for 20 instruments from one of these three big guys, the impact of this in terms of revenue will be next fiscal year.

 

 

 

B. Quirk

 

So essentially zero revenue from any of these three accounts in...

 

 

 

G. DeChirico

 

Yes.

 

 

 

B. Quirk

 

And then secondly, just thinking about the pricing component this quarter, the press release referred to the majority of the European increase being related to pricing. Can you drill that down a little bit more for us? I suspect it was actually less than the $11.4 million referred to in the press release.

 

 

 

G. DeChirico

 

Yes, because like Patrick just said, we had half million dollars in lost revenue for exchange rate and the results of volume impact. I don’t have the detail on that.

 

 

 

E. Gallup

 

It is $10.4 million came from price increase, so there is an additional one million dollars from volume plus the number, the half million Nino just mentioned, so about $1.5 million from volume growth.

 

22



 

B. Quirk

 

Understood. Thanks very much, guys.

 

 

 

Coordinator

 

David Zimbalist with Natexis Bleichroeder, you may ask your question.

 

 

 

D. Zimbalist

 

Yes, I just wanted to clarify, the 20 remaining instruments that are competitive takeaways, we should be thinking about them as contributing when they convert at sort of the 100 to 120 kind of range or do you think that they have equal potential to the current run rate for Galileo’s of 100?

 

 

 

G. DeChirico

 

One hundred and forty is our average, so that should be the number.

 

 

 

Dr. Simbalis

 

Is that 140 today entirely the increase all driven by volume or does that also include price in terms of the sequential change?

 

 

 

E. Gallup

 

Mostly volume.

 

 

 

D. Zimbalist

 

Thank you.

 

 

 

Coordinator

 

Dave Hoeft with Evergreen Investments, you may ask your question.

 

23



 

D. Huff

 

Thank you. On the August 3, 2005, conference call, Brazil and China were mentioned as market opportunities or geographies that could potentially be developed. I have not read or heard anything from the sell side since then. Is that still on your radar screen? If so, what kind of time frame, maybe for applications or some joint venture work? Thank you.

 

 

 

G. DeChirico

 

It is still in our radar screen. We found out, and I think we discussed this in the last conference call, that Brazil had a lot of issues to be addressed like high importation costs and high regulatory costs. Then we are now looking at some other countries in South America with the same partner we were talking before. We hope we can finalize a contract; we are talking now about Bolivia, Argentina. We are hopeful we can close a contract as a starting point with one of these countries. We just put them aside Brazil because of all of these issues I mentioned before. We lost time looking at Brazil. We spent more than two months looking at Brazil to find out that there was very little opportunity for both of us, us and our partners.

 

 

 

D. Huff

 

And what about China, please; any joint venture work or any visibility progress? Any thoughts?

 

24



 

G. DeChirico

 

Those are still in the same package of discussion with this partner, but we also for China we decided to hold until we have a general agreement signed and then we can go there. There is a lot of work to do in terms of due diligence and going to the country and looking at what is an opportunity, training. We thought China was too big to start with.

 

 

 

D. Huff

 

Thank you very much. Congratulations on better execution.

 

 

 

, I show no further questions.

 

 

 

E. Gallup

 

Thank you, operator. And again, thank all of you for participating. We will continue this process in the future, and we are always pleased to have this opportunity.

 

 

 

 

 

Thank you very much. Good-bye.

 

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