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1 FSX CONFERENCE E NABLING THE E ARLY D ETECTION AND P REVENTION OF B REAST C ANCER T HE B REAST H EALTH C OMPANY ™ A PRIL 2013NASDAQ: ATOS ©2013, A TOSSA.

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Presentation on theme: "1 FSX CONFERENCE E NABLING THE E ARLY D ETECTION AND P REVENTION OF B REAST C ANCER T HE B REAST H EALTH C OMPANY ™ A PRIL 2013NASDAQ: ATOS ©2013, A TOSSA."— Presentation transcript:

1 1 FSX CONFERENCE E NABLING THE E ARLY D ETECTION AND P REVENTION OF B REAST C ANCER T HE B REAST H EALTH C OMPANY ™ A PRIL 2013NASDAQ: ATOS ©2013, A TOSSA G ENETICS, I NC. A LL RIGHTS RESERVED.

2 2 F ORWARD L OOKING S TATEMENTS E XCEPT FOR THE HISTORICAL INFORMATION CONTAINED HEREIN, THE MATTERS SET FORTH BELOW, INCLUDING STATEMENTS REGARDING A TOSSA ’ S PLANS, REGULATORY ACTIONS, A TOSSA ’ S RESPONSES TO REGULATORY ACTIONS, EXPECTATIONS, PROJECTIONS, POTENTIAL OPPORTUNITIES, GOALS AND OBJECTIVES ARE FORWARD - LOOKING STATEMENTS WITHIN THE MEANING OF THE " SAFE HARBOR " PROVISIONS OF THE P RIVATE S ECURITIES L ITIGATION R EFORM A CT OF T HESE FORWARD - LOOKING STATEMENTS ARE SUBJECT TO RISKS AND UNCERTAINTIES THAT MAY CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM THE ANTICIPATED RESULTS, INCLUDING THE RISKS AND UNCERTAINTIES ASSOCIATED WITH ACTIONS BY THE FDA, REGULATORY CLEARANCES, RESPONSES TO REGULATORY MATTERS, A TOSSA ’ S ABILITY TO CONTINUE TO MANUFACTURE AND SELL ITS PRODUCTS, THE EFFICACY OF A TOSSA ’ S PRODUCTS AND SERVICES, THE MARKET DEMAND FOR AND ACCEPTANCE OF A TOSSA ’ S PRODUCTS AND SERVICES AND OTHER RISKS DETAILED FROM TIME TO TIME IN THE A TOSSA ’ S, FILINGS INCLUDING ITS REGISTRATION STATEMENT FORM S-1 FILED A PRIL 5, 2013, AS AMENDED AND SUPPLEMENTED FROM TIME TO TIME. A TOSSA UNDERTAKES NO OBLIGATION TO REVISE OR UPDATE ANY FORWARD - LOOKING STATEMENT TO REFLECT EVENTS OR CIRCUMSTANCES AFTER THE ISSUANCE OF THIS PRESS RELEASE.

3 3 E NABLING THE E ARLY D ETECTION AND P REVENTION OF B REAST C ANCER K YLE G USE C HIEF F INANCIAL O FFICER

4 4 C OMPANY O VERVIEW B REAST C ANCER P REVENTION 110M W OMEN A GE 18 TO 73 C LASS II FDA M EDICAL D EVICE CLIA-C ERTIFIED L AB “T HE P AP S MEAR FOR B REAST C ANCER ”

5 5 H IGHLIGHTS L ARGE AND G ROWING MARKET O PPORTUNITY C LASS II FDA M EDICAL D EVICE / CLIA-B ASED L AB C OMMENCED C OMMERCIAL LAUNCH S TRONG P ATIENT D EMAND – W OMEN ’ S H EALTH D RIVEN $70M+ SPENT ON 178 P ATENTS /11 C LASS II FDA DEVICES A TTRACTIVE F INANCIAL M ETRICS AND M ODEL E XPERIENCED M ANAGEMENT T EAM

6 6 M ARKET O PPORTUNITY 110M W OMEN IN U.S. A GE 18 TO 73 B REAST C ANCER O CCURS : O NE P ER M INUTE 24/7 80%: C ERVICAL C ANCER P REVENTED BY P AP S MEAR F EW O PTIONS FOR W OMEN <50 YRS 55M P AP S MEARS / YEAR 39M M AMMOGRAMS / YEAR

7 7 F ORE CYTE B REAST H EALTH T EST C LASS II FDA M EDICAL D EVICE N ON -I NVASIVE B IOPSY CLIA-B ASED T EST B ACKED BY 17 P ATENTS 2012 R EVENUE /T EST : $579 M EDICARE /I NSURANCE R EIMBURSABLE T ARGET U.S. M ARKET : 110M W OMEN A GE 18 TO 73  A SSESSES THE 10-Y EAR AND L IFETIME R ISK OF B REAST C ANCER

8 8 F ORE CYTE B REAST H EALTH T EST : B ENEFITS P ROVIDES R ISK A SSESSMENT -10 YR, L IFETIME D ETECTS C ANCER UP TO 8 Y EARS B EFORE M AMMOGRAPHY S UPERIOR TO M AMMOGRAMS (39M/ YR IN U.S.) M AMMOGRAMS ARE D EFICIENT FOR D ENSE B REASTS M ORE C OST E FFECTIVE THAN B IOPSIES (1M+/ YEAR AT $6,000 COST ) T HE “P AP S MEAR ” FOR B REAST C ANCER

9 9 F ORE CYTE: H OW IT W ORKS AcellularCategory 0Category ICategory IICategory IIICategory IV M ICROSCOPIC R ESULTS F AMILY H ISTORY OF B REAST CANCER P ERSONAL R EPRODUCTIVE H ISTORY IBIS R ISK A LGORITHM (Peer reviewed algorithm developed from a registry of 158,041 women in whom 3,257 breast cancers occurred) N ORMAL R ISK <15% I NTERMEDIATE R ISK 15 TO 20% H IGH R ISK >20%

10 10 F ORE CYTE R ISK A SSESSMENT – W HAT IT M EANS N ORMAL R ISK <15% I NTERMEDIATE R ISK 15 TO 20% H IGH R ISK >20% R ETEST IN 1 TO 2 Y EARS TO E STABLISH B ASELINE R ETEST IN 6 M ONTHS WITH L IFESTYLE I NTERVENTION I MMEDIATE A CTION “E DUCATE ”“M ONITOR ”“T REATMENT ” 90M W OMEN 10M W OMEN

11 11 S ALES AND M ARKETING A DDRESS L ARGE AND D IVERSE M ARKET FROM M ULTIPLE P OINTS : N ATIONAL L AUNCH WITH C LARITY A TOSSA I NDEPENDENT S ALES R EPS F UTURE D ISTRIBUTORS F UTURE M ANAGED C ARE G ROUPS C HANNEL F OCUSED N ATIONAL A WARENESS P ROGRAM - U LTIMATELY D RIVES A DOPTION IN THIS V ERY A CTIVE P ATIENT P OPULATION

12 12 C LARITY U PDATE : Q J ANUARY : T EACH - IN TO CA 20 C LARITY CHANNEL PARTNER REPS F EBRUARY : N ATIONAL L AUNCH AT P RI -M ED S OUTH PRIMARY CARE LEADS GENERATED M ARCH : P RI -M ED S OUTHWEST PRIMARY CARE LEADS GENERATED M ARCH : P RODUCT C ODES E STABLISHED WITH H ENRY S CHIEN, PSS, M C K ESSON REPRESENTING 1809 R EPS M ARCH : R EP O UTREACH /T EACHING B EGUN : H ENRY S CHIEN, 491 R EPS ; PSS 598 R EPS ; M C K ESSON 720 R EPS T HREE - CALL SALES CYCLE OVER 30 DAYS TO ESTABLISH AN OFFICE 1 ST KITS 15 DAYS LATER

13 13 P RODUCT S TRATEGY – B REAST H EALTH C ARE P ATH N EWLY DIAGNOSED P ATIENTS H IGH R ISK P ATIENTS B REAST C ANCER S URVIVORS I NITIAL C ANCER R ISK A SSESSMENT C URRENT P RODUCTS F UTURE P RODUCTS 110M W OMEN (S TRATIFY ) 3M W OMEN (M ONITOR ) 10M W OMEN (A SSESS ) 235K W OMEN /Y R. (P ROFILE )

14 14 P ATIENT C ASE S TUDY : B OTH W OMEN A GE 50 Y W EAK F AMILY H ISTORY S TRONG F AMILY H ISTORY P RE -T EST R ISK : L OW P RE -T EST R ISK : H IGH P OST -T EST R ISK : H IGH P OST -T EST R ISK : L OW

15 15 I NSURANCE R EIMBURSEMENT U SE OF E XISTING R EIMBURSEMENT C ODES M OST I NSURANCE C ARRIERS ARE P AYING A VERAGE REIMBURSEMENT OF $579/ TEST U SING T HIRD P ARTIES FOR F AST C OLLECTION P ROCESS P AYER C ONTRACTS WITH M ULTIPLAN AND F EDMED 97M P EOPLE C OVERED S TEPPING S TONE TO I N -N ETWORK C ONTRACTS

16 16 I NTELLECTUAL P ROPERTY FDA M EDICAL D EVICE A UTHORIZATIONS – ( K )-C LASS II M EDICAL D EVICES AND T WO 510- E XEMPT C LASS I M EDICAL D EVICES CLIA-B ASED L ABORATORY D EVELOPED T ESTS – F OUR V ALIDATED T ESTS P ATENTS – 178 I SSUED AND 50 P ENDING T RADEMARKS – O NE R EGISTERED AND S IX P ENDING

17 17 C OMPETITION M AMMOGRAMS B IOPSIES P HYSICAL E XAMS T ARGET E FFECTIVENESS E ASE OF U SE C OST A LL W OMEN A GE : H IGH E ASY L OW W OMEN A GE : 40+ M ODERATE E ASY L OW W OMEN : H IGH R ISK M ODERATE I NVASIVE H IGH A LL W OMEN A GE : L OW E ASY L OW

18 110M A NNUAL $500 $90M 18 C OMPARISONS M YRIAD G ENETICS MYGN G ENOMICS H EALTH GHDX T ARGET F REQUENCY C OST M ARKET C AP 0.6M O NCE I N L IFETIME $3,000 $2,000M 0.3M O NCE I N L IFETIME $4,175 $880M

19 19 G ROWTH S TRATEGY C ONTINUE F ORE CYTE / A RGUS CYTE N ATIONAL L AUNCH I NCREASE P RODUCT A WARENESS AND E DUCATION B UILD B ROAD N ETWORK OF D ISTRIBUTORS L AUNCH F ULL CYTE AND N EXT CYTE C ONTINUE D EVELOPMENT OF I NTRA D UCTAL T REATMENT E XPAND L ABORATORY S ERVICES O PERATIONS I NCREASE I NSURANCE A CCEPTANCE AND R EIMBURSEMENT

20 20 M ANAGEMENT T EAM AND B OARD M ANAGEMENT T EAM S TEVEN Q UAY, C HIEF E XECUTIVE O FFICER * K YLE G USE, C HIEF F INANCIAL O FFICER S HU -C HIH C HEN, C HIEF S CIENTIFIC O FFICER * C HRISTOPHER D ESTRO, VP S ALES AND M ARKETING M ICHAEL M ALAFRONTE, VP O PERATIONS B OARD OF D IRECTORS J OHN B ARNHART, D ISNEY C ORPORATE V ETERAN D R. S TEPHEN G ALLI, S CIENTIFIC E XPERT /S TANFORD F ACULTY C HAIR D R. A LEXANDER C ROSS, P HARMA V ETERAN H. L AWRENCE R EMMEL, B IOTECH L AWYER * M EMBER OF THE B OARD OF D IRECTORS

21 21 F INANCIAL H IGHLIGHTS H IGH “Q UALITY ” R EVENUE - G ROSS M ARGINS : >80% I NSURANCE R EIMBURSEMENT N O D EBT, N O P REFERRED S TOCK L EVERAGES I NDIRECT S ALES R EPS OF D ISTRIBUTORS S CALABLE L ABORATORY S ERVICES O PERATIONS M INIMAL C APITAL E XPENDITURES $70M+ OF C APITAL I NVESTED IN THE IP $30M F INANCING F ACILITY WITH A SPIRE C APITAL

22 22 I NCOME S TATEMENT

23 23 B ALANCE S HEET – D EC. 31, 2012 ($ in thousands)

24 24 C APITALIZATION

25 25 B USINESS H IGHLIGHTS L ARGE AND G ROWING MARKET O PPORTUNITY C LASS II FDA D IAGNOSTIC M EDICAL D EVICE / CLIA- B ASED L AB C OMMENCED C OMMERCIAL LAUNCH S TRONG P ATIENT D EMAND – W OMEN ’ S H EALTH D RIVEN $70M+ SPENT ON 175 P ATENTS /11 FDA DEVICES A TTRACTIVE F INANCIAL M ETRICS AND M ODEL E XPERIENCED M ANAGEMENT T EAM

26 26 E NABLING THE E ARLY D ETECTION AND P REVENTION OF B REAST C ANCER T HE B REAST H EALTH C OMPANY ™


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