- 02. Mission Statement and Product Positioning 5 mission and positioning within the market ‘Summary of Accutan © Strategic mission The strategic mission for the Accutane team is to: Continue to grow the brand through increased appropriate use in well qualified and well counselled patients. Protect the franchise iong-term through product and market development activities which resutt in additional market exclusivity for Accutane, < Supporting Strategies ‘There are four key strategies which have become the core in marketing the Accutane brand All other strategies flow from tnese strategies listed below: Insure appropriate use of Accutane, with specific emphasis on females of childbearing potential 2. Drive untteated disease sufferers, especially young men with severe acre, to seek medical treatment of their acne, 3. Facilitate and enhance an ongoing dialog between doctors ang patients so that patients have a realistic expectation of their treatment and ultimately are satisfied that their acne has been effectively treated 4. Protect the brand franchise long term through timely revision to, and implementation of the lifecycle plan, and by responding swifty and decisively to all threats to the Accutane brand. Personal promotion, joumal advertising, direct mail, Physician & Nurse Speaker Programs, publications on Accutane new formulation willbe the key venues employed in reacting our target healthcare professionals, Television (ORTV), Print and intemet will be used to reach consumers. Pharmacy CE, Pharmacoeconomic studies data and other value-added programs willbe used to faciitate conversion to Accutane new formulation in the Managed Care setting Itis vital that Roche continue to expand the knowledge base around the treatment of acne and related conditions. Roche will also continue to define possible and potential Adverse Events. The integrated ‘medicat plan will focus on these issues through publication strategies, Roche sponsored trials, and invesbgator initiated studies. ‘The successful launch and market conversion from Accutane current formulation to Accutane new formulation (stated for March 2001) is absolutely essential and critical, not only to year 2001 product revenues, but to all future year revenue flows. (important Note: A separate, completely inclusive Accutane New Formulation Launch Plan, executed in both hard copy and as a BOG presentation is planned for mid-year.) © Product positioning statement FRoshe Laboratones, Ine. Sttly Confdentia! 1 2001 Product Strategic Plan for Accutane HLR 035066‘The Accutane product position is as follows: ‘Severe acne is a disease which may cause profound negative physical and social effects if not adequately treated. Accutane is the only product capable of producing dramatic clearing and long-term remissions in patients with severe recalcitrant nodular acne, {Important Note: This positioning statement will be modified to include additional key benefits pending the completion of Market Reseach activites on the new formulation.) However, Accutane must be used with caution because it is a teratogen and may potentially cause serious Adverse Events, © Product Key Promise Only Accutane has produced dramatic cleanne of the most severe types of acne (SRNA) ant maintaines that clearme for the tong term (imporani Note. This product Key promise statement will be mocified to include additional key benefits pending the compietion of Market Reseach activities on the new formulation.) ‘Roche Laboratones, ine. Stacy Confident 2 2001 Prose: Strategic Plan for Accutane HLR 03506703. Situational Analysis A. Patient Dynamics Demographics ‘Accutane continues to be the only effective therapy for severe recalcitrant nodular acne. Since 1996, ithas experienced annual true growth in excess of 10% per year. It continues to outpace all other ‘major acne therapies. ‘A major par of this growth has been in the patient pool itself. There are no studies to indicate the actual incidence and prevalence of severe recaicitrant nodular acne in the United States. The latest ‘available study on ine general prevalence of acne was conducted by NHANES in 1874, According t° estimates. approximately 2% cf the population suffers from acne, OF this group. 22% have severe ‘acne. As of the atest population count (March, 2000} this puts the count of severe acne sufferers at 1,208,000, This aiso represents an increase of 5.5% i the severe acne sufferers over 1995. According to NDC Health, at year end 1999 there were 4 totai of 556.325 total patients on Accutane. (Please refer to Graphs in attached worksheet) The total number of Accutane patients are growing faster than new patients (refer to Graph 1). This suggests that the duration of therapy is increasing over time. In 1996, a pilot Acne awareness DTC campaign was launched. Up to this point, @ widening gap in male and female patients can be observed in Graphs 2 & 3 for New and Total Accutane patients respectively. The female share of ‘Accutane patients has histoncally been higher than that of males -in the peak gap of 1996, the patient shares for males and female were 55% and 45% respectively. Subsequent years have seen a closing ofthis gap, and, in 1999, the total patient poo! was split exactly in half This can be viewed, in part. a5 2 result ofthe DTC campaign that is targeted towards teen males, Graph 4 shows that teen groups (12-19 years old) make up the lion's share of Accutane patients, and have increased significantly in the last four years as a resutt of the male teen targeted DTC program. The teen male patients nave increased by over 25% between 1998 and 1999. This group Is also the fastest growing one of all Patient groups. Beginning in 1997, consumers became an important promotional target regarding acne’therapy. This ‘wend is expected to continue throughout 2000 and beyond, From the beginning, the objective of Roche's drect to consumer (DTC) non-branded acne campaign was to drive untreated acne sufferers to seek therapy from a doctor. The acne awareness DTC campaign targets the teen male audience, ‘and their moms, because young men suffer from more severe acne, with a longer duration, than their female counterparts. and because moms are generally the key decision makers in the household. In ‘addition, research shows that males are less likely to seek medical treatment for acne than females. ‘Additionally, NDTI data clearly shows acne diagnosis visits for males increased al a faster rate than females in 1998, and actually surpassed those of females in 1998. ‘Managed Care: Managed Care is increasingly taking an important role in this therapeutic area. Aimost 89% of the Derms panicipate in Managed Care Plans, Increasing numbers of Derms (51% in 1898 from 44% in 11998) indicate being influences by formulary restrictions for prescribing acne products to their managed care patents. Accutane is available on 93% of the formularies, of which 86% is unrestricted Roche Laboratories, Inc. Stretly Content! 3 200 Product Stategs Plan for Acoutane HLR 035068while 7% is restricted. 70% of all Acne prescriptions in 1999 were covered by private insurance. 22% of the prescriptions were cash patients. Compared to the Acne market, Accutane private plan reimbursement is 87.5% of all prescniptons, while 11.3% is cash. FDA: In February 1988, Roche and the FDA concluded a year-long dialogue on the issue of psychiatric disorders in patients treated with Accutane. The scientific inquiry and subsequent negotiation resulted in an additonal waming in the Accutane label which states, in part. that "Accutane may ‘cause depression, psychosis, sutcide attempts, and. rarely suicide." Although there was extensive media coverage in reference to the label change, prescnbers were apparently unmoved by this. information. Therefore, it did not have @ subsequent negative effect on prescnbing habits. While primary research conducted eartier in 1998 revealed that dermatologists were previously aware of the potential for mood changes in Accutane patients (stated in the package insert since 1986) , they fet the nature of the disease state itself may predispose severe acne patients to be a population at risk for depression. Additionally, those physicians interviewed who had also treated a patent experiencing depression while on Accutane, could identity confounding factors in the patient's personal o° medica! history ‘Ongoing surges of negative publicity continue in the press, both domestically as well as internationally. fuelles primaniy by a fathes in tratand, who continues to express desire to blame the death of his son on depression “associated” with his teen's use of (Ro)Accutane. An organization has been formed by the father called R.A.G.E. (Roaccutane Action Group Enforcement) with periodic meetings, 3 newsletter, and 2 website, The Accutane Medical Excellence team worked swiftly to handle the situation regarding these issues as they arose and on an ongoing basis looks towards ways of handling these types of situations more proactively. In addition to psychological issues, adverse events associated with the use of Accutane, also ‘continue to be under FDA scrutiny. To that end, the approval of the present rewrite of the Accutane package insert (including modifications to Adverse Events, Precautions and Warnings sections).has been prompted by a request by the Agency. The total label modemization, including PPP inclusion, is expected in April 2000. tis an FDA requirement tnat an Action Letter regarding the approveble nature of the Accutane new formulation be sent to Roche by October 31, 2000. Futher, due to the wealth of product label revisions which are being conducted on the currently marketed product label, it's both anticipated and ‘assumed that any further label changes will be additive to these changes, which should result in some “economies of time”, regarding final new formulation label approval. These activities would greatly assist in realizing the goal of making the March 2001 launch of Accutane new formulation possible Roche Laporatones, Ine. Stnety Confsent ‘ 200% Product Strategic Plan for Accutane ALR 035069\. Patient Dynamics ... continued © Roche Laboratones, Inc. Stnetty Confentiat 2001 Product Strategic Plan for Accutane HLR 03507003. Situational Analysis B. Major Competitors/Mkt. Definition & Mkt. Share Market Definition: ‘Accutane continues to be the only effective therapy for the management of severe recalcitrant cystic ‘acne since the product was introduced in 1982. With no direct competitors, Accutane use continues to grow as patient visits and Accutane mentions increased significantly in 1999 (20%). While Dermatologists treat significantly more severe acne patients than the primary care specialities (GP/FP/IM) combined (2*% of all patients for derms compares to 13% for PCPs in 1989), an increasing number of mild and moderate patients are seeking acne treatment with the PCPs. AS ‘expected PCPs treat significantly more new acne patients than dermatologists. About one thifd of PCP acne volume is comprised of new patients, compared to less than one quarter of dermatologists’ ‘acne patients. Of acne patients treated with all therapy typés, the severity of acne is broken out as. follows: Dermatologists Primary Care Physicians Severe Acne 21% 13% Moderate Acne 49% 43% Mild Acne 30% 40% Since dermatologists see more severe acne patients than primary care physicians, itis not surprising that they would also prescribe more Accutane. In fact, in 1999 dermatologists accounted for more than three quaners of ali Accutane presenptions (77%) - changing lite over the previous year. Primary care specialities accounted for 10% of Accutane prescriptions in 1999, a 2% increase ‘compared to 1998. The remainder of Accutane prescriptions were divided in very small percentages ‘among a diverse range of specialities. Examples include OB/GYN and pediatrics, accounting for less than one percent respectvely. Accutane was prescrived to just under 574,120 patients in 1999. Last year, 50.7% of Accutane use ‘occurred in female patients, while males accounted for 48.3%. Teens between 12 and 19 years of ‘age accounted for more than haif of Accutane patients, while adults between the ages of 20-39 years accounted for 30%. Males make up slightly iess than haif of the Accutane new patient population ‘Among teens (12-19 years old) however, males comprise 65% of patients, an increase of 1.5% over the previous year, Double digit prescription growth was first reported for Accutane in 1996 at 12%. This trend continued in 1998 and 1999, each demonstrating a year-end total prescription increase of 14% and 10.3%, respectively. Total prescriptions have continued this trend through the first quarter of 2000, growing 6% over the same period last year. Factors influencing Accutane growth include the impact of a dedicated dermatology sales force, and effective implementation of professional and consumer promotional programs. The number of Roche Laboratones, Ine. Stity Confientat 6 2001 Product Strategic Plan for Accutane HLR 035071‘Accutane presentations for 1999 totalled 67,800. This represents an increase of 7% over 1998, Market Share: ‘The market for treatment of severe recaicirant cystic acne contains no true competiors to Accutane Itis a highly efficacious product, and re-treatment rates are minimal when Accutane is dosed appropriately. Bacterial resistance, a concem among leading antibiotic treatments (18% occurrence), {is unikely tc develop with Accutane. Because of this product feature, one strategy Deing initiated in 2000 1s to ensure that Accutane is positioned in “reasonable” acne trestment algorithms within the Managed Care business segment, so as fo kmit patient exposure to multiple courses of systemic antibiotics, and potentially faciitate an “earlier trial of Accutane. ‘The anti-acne treatment category includes topical agents (such as oral retinoids. antibiotics and benzoyl peroxides) nt-bactenal drugs) and oral contraceptives is visits, has Deen relatively small, wit © systemic products (chiefly Growin of tne acne market. measured in terms of acne diag: an increase of 4-8% over the past tnree years. Status of Current Acne Agents Dermatologists are more satisfied with available crug therapies for mild and severe acne. while oserate forms present their greatest treatment challenge. In contrast, PCPs are more satisfied with Current therapies for mild acne, and are much less satisfied with those avaliable for severe acne. Use of topical retinoids by dermatologists has increased over the past year, Diffenn and Retin-A Micro ‘are brands most preferred, specifically when prescribed in a cream or gel form, These agents are primanly chosen because they are effective with less iritation. Use of Differin has increased more than any other product compared to last year, and use of Retin-A has declined as it has been replaced by Retin-A Micro and by pharmacy generic versions (first genenic out in1998 which are sold at approximately 50% of the brand price). Additionally, dermatologists anticipate an increase in their use of Avita, Klaron and Tazorac. Among oral antibictics, Minocycline and Tetracycline (generic) are ‘most preferred. Physicians select them because of therapeutic and cost efficacies. ‘Acne Market : Snapshot of Performance : Sales activity for Accutane was compared against the products listed below. They are not direct ‘competitors. but have high usage patterns in the treatment of acne. Within the acne market (as defined by Roche), total DDD dollars grew 4.7% between 1998 and 1999. Roche Laberatones, Ine. Stutly Canfcential 2001 Product Strategtc Plan for Accutane ALR 035072“Rene Produat | Classification | DDD TSMM) | DDD (smn) ‘i Change] 1980 % Share oF FY 1909 Gaal DDD Marnet eaiane walremed sa SBT sieae re ‘Biter Sealed | SRE Tea ore i Reine ‘peared [Si ee |e ae Teaoyane | Sem ames, —_—_ SEE SEE a | DeseaT | alate | SBT ae ae 7 Baines | eaeserim | __FT SeET TET Tose l J Roche Laoratores, Inc. Sticty Contenta! 8 2001 Product Strategic Plan for Accutane HLR 035073urd +S Sa a To Tora “aes ea. Lt Pobre sees aN Seek awed aeseprr vet sess T ro peso els Roche Latoratones, nz. Sincty Confiventa! ° 2001 Product Strategic Plan for Accutane HLR 035074B, Major Competitors/Mkt. Definition & Mkt. Share ... continued Roche Laboratories, Inc Stcty Confer 0 2001 Product Strategic Plan for Accutane HLR 03507503, Situational Analysis ©. Customer Segments ‘The most significant Accutane customers are dermatologists. in 1998. as in the previous two years, dermatologists accounted for 77% of ali Accutane prescriptions writen. The majonty of dermatoiogists (95%) prescribe Accutane to approximately 12% of thei acne patients. Satistacton with Accutane as a proven effecte therapy for Severe acre is demonstrated by 8 patient isconbnuation rate of only four percent. Further increase in Accutane use will come from current preserbers, since very few cermatologists have no experience with the product (less than 1%). In contrast. primary care physicians comprise the second highest Accutane use’ group, accounting for 40% of ali Accutane prescriptions ir 1998. As previously stated, the remainder of Accutane prescriptions are widely distributed in smal! percentages over ¢ large variety of special Market research shows that the majority af dermatologists (89%) and PCPs (86%) participate in at least one managed care plan. Like the previous year, in 1999, Derms reported a higher proportion of HMO patient volume than PCP's A sizeable portion of bath dermatologists and PCPs (51% and 50% respectively) state that restrictions imposed by HMOs and PPOs have a growing influence in their choice of acne products to prescribe. This is a considerable increase from 1998's response of 44% and 46% for Derms and PCPs respectively. About 28% of the Derms and 40% of the PCPs indicate that their use of Accutane is restricted by managed care. While the majority of acne patients have coverage for medication through private heatth insurance (including indemnity, HMOs, PPOs, etc.), there is stil a sizeable proportion of patients with NO prescription reimbursement pian, Less than one quarter of patients have no prescription coverage. Prescription coverage for acne patients is depicted below: Dermatologists Primary Care Physicians Private Health Insurance 70% 65% Medicaic 8% 14% ‘No Insurance 22% 21% Consumers are another key segment of Accutane customers. In 1999, acne awareness OTC ‘promotion continued to focus on driving male teens into the doctor's office. Teenage boys and men suffer from more severe forms of acne, and m many cases their condition persists longer than acne conditions expenenced by teenage girls or women. ‘There were over 209.000 new male Accutane patients in 1998, an increase of 16.6% over 1998. Female patients numbered nearly 216,000, an increase of 8.3% over last year, Simitariy, NDTI data shows that acne diagnosis visits grew 12.8% in 1999 compared to 1998, which was the largest increase of visits over the last 6 years - indicating that many more patients are visitng a physician for aene consultation. Its important to note that in addition to Roche's nor-branded acne campaign, several other dermatology products began DTC advertising programs in 1999 (both branded and unbranded), and have undoubtedly contributed to the overall increase in visits. Roche Laboratores. Inc. Stncty Confential ” 2001 Product Strategic Plan for Accutane HLR 035076‘When the overall number of acne diagnosis visits are broken out by gender, males accounted for 44% of all visits. However, male visits are growing at a much faster rate (16% in 1899 over 1998) than female visits (10% over the same period). The fact that male patients are both seeking treatment for ‘acne, and are being treated with Accutane at an increasing rate compared to their female counterparts, suggests that the DTC acne campaign is having its desired effect, Roche Laboratories Inc, Stncty Confit! 2 2001 Product Strategic Plan for Accutane HILR 035077Results of a tracking study regarding the 1998-1988 unbranded acne direct to consumer advertising campaign shows that teens and mothers whose sons fave acne are well aware of acne advertising land, as such, contnbute greatly to ad-reiated calls to action, Prompted ad-awareness was 45% in 3 survey of consumer teens and mothers whose sons have acne following exposure to non-branded print and television advertising ‘An ROI analysis of the Acne 1999 (Spring and Fall) campaign was conducted utilizing three different study methodologies: (1) a point in time study. (2) an advertising agency model. and (3) a statistical regression analysis. While study results vared from one model to the next, they each concluded that 2 favorable ROI for the Acne DTC campaign, which approximates a 31 ratio, exists, The statistical regression analysis provided further ingication that the most efficient use of promotional funds, in order of ROI, was sales force, print and TV. In Fall of 1988, the DTC campaign was guided with a ‘buy management’ process which addressed the needs to increase the numper of completes calls 2. Grow business by tapping into vanous market segments, such as ethnic and age groups The leamings trom the Fall 1999 campaign were applied to the roll-out of a fresh, new Acne DTC ‘campaign in the Spring of 2000. As a direct result of this combination of buy management process land the new Acne DTC program, the calls from the Spring 2000 TV campaign have creased by over 40% compared to the Fall 1999 campaign. Roche Laboratones ne. Sinety Content 2 2001 Produet Strategic Plan for Accutane HLR 035078C. Customer Segments ... continued Roche Laboratories, Ine, Sinctly Confidential “ 2001 Product Strategic Pian for Accutane HILR 03507903. Situational Anal D. Pricing Trends ‘Since January 1997 to date (March 2000), there have been 13 price increases totaling 48.2%. In 1999 alone, price increases totaled 10.3%. ‘The formutary status and reimbursement profile for Accuamne has been discussed previously under Part C of the Situational Analysis (Customer Segments). The daily consumption of Accutane as a brand changed litle in 1999 over 1998, The only excepton was ‘20MG. the daly consumption of which increased by 2% over 1998. The total therapy days per prescription rose by about 2% in 1999, The largest increase in therapy days per prescription was ‘seen in 10MG, which increased by approximately 4% over 1998. The only area of true growth was ‘seen in the total therapy days for Accutane. Consistent with the last three years, Accutane total therapy cays grew by about 16% in 1998, This means that patients are staying on therapy longer than they nave before, More specifically, tne biggest therapy duration increases came from 20MG and 40MG, respectively This increase in the total number of days of therapy is another major factor that has contributed to the success of Accutane, and the tremendous growth in prescnptions. (Note: The 40MG SKU is the iargest selling strength - representing over 70% of all Accutane sales.) Product launch pricing for Accutane new formulation willbe a significant factor in completing the Successful market conversion from the currently marketed formulation . (Note: As previously ‘mentioned in this document, the complete Accutane New Formulation Product Launch Plan will be scheduled for a mid-year presentation to the BOG.) ‘The overall cost of Accutane therapy increased by 12.4% in 1999 over 1998. Even though the cost of therapy has consistently increased over time, there is very litle impact on the growth of prescriptions. ‘The following graph shows increases/decreases in average retail cost of therapy per day across all ‘comparable products: Increase in Approximate Retail Cost of Therapy Per Day- 1999 over 1998 140% 120% 100% a0% 50% 4% ‘%increase 20% | oom Roche Laboratories, Inc. Stncty Confgentia 6 12001 Produc: Strategic Plan for Accutane HLR 035080D. Pricing Trends ... continued Roche Laboratones. Ine. Stnetly Confit 6 2001 Product Strategic Pian for Accutane ALR 035081is 03. Situational Analy: E. Revenue Driver Key Assumptions ‘Resumption: Pregnancy Prevention Validation ‘Additional Validation {Risk Though voluntary, the FOA inclusion of PPP in the current | Moderate may require PPP PPP Label provides a bamner to generics. | Interaction of FDA's Derm j Division and OGD to insure that PPP becomes a labeling requirement for ANY oral Isotretinoin | ‘Assumption Phycician Prescriber Program (LWaiidation [Additional Validation Risk Wie Primaiy Research shows} | mnat Roche Derm Reps provide | the fnest patent and physician education materials, hey fag in providing adequate detaling This ss primarily as a resu of signifcanty fewer Roche Derm rep FTE's as compared to cine Derm companies. Roche is the #1 Derm company (revenues) ata fraction of the detals of the nearest competion Physician Detailing Audit confirms relative detailing levels among Derm companies | Unknown: Itis extremely diffcutt to attempt to predict the cefect in prescriptions as 2 result of a iower level of Accutane details (vs. other Derm companies). Without research to attempt to quantify the effect of increased details, the true effect of additional details cannot be known. Moderate to High: Increasing the level of Detailing may reveal additionat, previously untapped revenue potential ‘Assumption: DTC Acne Campaign Validation ‘Additional Validation Risk Historical Accutane Gata shows) strong relationship between DTC campaign and units sales ‘Analysis of secondary data from callers proves that better targeting improves the revenue potential of the product. = RCL Point-in-time study - Statistical Regression Analysis = ROI Analysis (3 methodologies) High: Increased units sales are very sensitive to DTC spending levels Roche Laborstones Inc. Stnetly Confgential 2001 Product Strategic Plan for Accutane HLR 035082=Media Buy-Management | ‘Resumption: ‘Accutane New Formulation Conversion (Watigation ‘Adaiional Validation Risk Primary research is underway | Secondary research from High: Delayed/Siow andlor to investigate appropriate analog models suggests that_| improper conversion of the conversion from existing to new) early and proper conversion of | _ formulation will have significant formuiation line extension products is ‘short and long term effects on needed the revenue. Rapid physician Market conversion from | conversion and rehabitutaion to TTegison to Soriatane indicates | me new Accutane formulation the importance of increasing | will serve to slow the rate of product detailing levet and tts | generic penetration, when correlation to facilitating rapid | available in the marketplace. market conversion. Resumption ‘General Product Suppor Validation’ | Risk Primary and Secondary research shows that professional afflations ang programs (such as AAD and CME) have a desired positive effect on units sales Moderate: Activities serve to reinforce the position of Roche as a leader in Dermatology, and and the Accutane brand as the "Goid standard" for SRNA. Roche Laberatones Inc. Strty Confidential rr 2001 Product Stratepic Plan for Accutane ALR 03508303. Situational Analysis F. Product Performance Overview HSS Ful Year] 200010) HOD VTO™ | Variance 2000] 2000 Annual | 2000] 2000 LE va 1955] ‘Actual ‘Actual Budget | YTDActualv. | — Buaget Full Year Actual! Budget Wat Sa $e Sag sib abe 2B $620 $006, Ta Tike Share i Bap; T t Bone. Senpis | umber Ta eI ZB Ta Zoey cc] a ‘Share % r 1 Ope: i BOpB: Roche Laberatones, Ins. Stitly Confizentia 8 2001 Product Strategic Pan for Accatane LR 03508403, Situational Analysis G. SWOT Analysis. © Strengths and Weaknesses inclu Sreagihe ‘csviane has no Tue Gres conpettaw ir the Weaten! Of severe recaletrant eyste aone 19 attitudes and perceptions Wenner } Taney waa SET SOT NOTTS Toman he prey eny cones sooner me 358 | Foxman fr asesson-autes pou eins Changes andthe wanna eaves cranes 08 ens eran aa nage ecto ane Recaane & hah eficacoaa wih PIRATE TESTTO rates when cosed apprepnately “The nigh Wewence of mucscwlaneous sie effec (dry ipa eyes, face etc} remans the most voublesome side eflect expenenced by patents Te proUUEL Te animate calegoy WORE BF BFREINET sas Accutane | cevetanng agans: Acetone Recent research noteates inal musacuaneous effec GO not preset bare: to physician use of Accutane, and fare leads to aatert eezontnsaton (eM) Tins mperant te teat ence January 1657 there nave buen eleven once nemeases ‘claung 48245 (102% of his ineresse came 1999 alone). Almost 18% of al Accutane rescrenions are covered Dy cash “Azuara nas evang Buppar by SermaleIogSE Wr A professional promaton ana PPP. | “Raanoral year ot produc use contnae To crease he Como level among dermatciogsss and prmary care physicians who prescrbe Accutane ‘The petental or friar resinetions on Aculane preserbing by dermatologists continues to grow as almost 2 tid of ne cermataiogets (29%) reported kmtations when preserioing Accutane in 1999 compared to 19% in 998 Tew Formulation paSnGRNS ae Deel To reduce The vera consumption of units with onee-a-ay dosing, tus the launen prong eategy for ths proguet serial “The numberof patens resewing Ove Brand SonGAeE TS row ‘Onse-a-day Accuaine new formlaion dosing wih & reduced migra to muligeam ede effect profile would fencourage and facitate market cooverson. Roche's Derm Prysesan and Patent suppor Bragrare a7) Lnparaieled nthe acne therapeutic area, ane recognizes as such Roche Lasoratones, ins. Stncty Confident 20 2001 Product Strategic Plan for Accutane HILR 035085,G, SWOT Analysis ... continued © Opportunities and Threats (current and future) ‘Opportunities Tareas ‘Currant sais massages spesiving appropnate We oT ‘Accutane targeted at physicians may oave tne way for ne ‘new formusation (BID ooking. taken wh food) Reguatcry Scnany wil coninve ana May MISTS Consumers need more miomation sbout ane, an0 a0 the mporiance of seeing 2 physican for the veatment of Trareaeing Con prestures May Wead Wo Gibale Fesinclon managed care organizaions. Uriveaiea acre afiere’ custome’ bane & gh aware oT and responsive to DTC aaverving cals to ach. ‘Acdtionaly, customer segment marketing (e. ethnic) roves areal opooruney to exoand. establish and brovige ove yay to "new custome bases, ‘Broacive revisions tothe Accuiane Preghancy Prevent, Program (PP> are m progress wih planned “complete” Imoiementavon gate o* 700 i Resalorcarnen: ofthe Roobe mage af & adel ‘ermatlezy within the mecical community can be ‘ecompushed by focusing on promational detaling and key Customer relatonsmos Faure i gai repulsion approval fo nlusin ofthe Rone Pregnancy Prevention Program the Accutane product label would place the franchise at nk Failure te oem reguaioy approval ore new ResuTene ‘needa ormlation in be #95n08 (1000) woUte pik the franchise at sgnieant rsh ‘Dermatologists percenton othe ew Acaulahe one= ay formulabon may not be a5 favorable as oesire (recent research suggests that SO% of physioans already dose ‘Accutane QD) ‘Recuiane has 8 ayrames rulvTaceied Wa oye Bat Failure to gan repulaloy approval fo: Recuiane Pecan Excusiviy extension 2 timely fashon (prior to 4001) would sace the franchise a isk TLaunah, poss ihibugh parnerane@ Tormuabon af he Curertiy mareies Accutane arocuct as a brances gener Porto patent exprabor of caent Accutane, expore @ vvanery of scenanos which inclvdelaunh of branded aharmacy gener, wiv wnat @ derm barine Polenta for branded! pharmacy gore'k @nines existe following Accutane patent exary on Feoruary 2002 when Peaiatn exciusnny is grantee Prodi conversen of Azatane fo Accutane new formutaton may be accelerated fecitated trough one of the folowng methods Increase Germ sales force head count 70 FTE vs 35 * conareeng! o-promotion wih 2 complmentary \net-know erm company Roche Laboratones, Ine. Stnety Confcentil 2 2001 Product Stratege Plan for Accutane HLR 03508604. Business Objectives and Measurements A. Base Case Revenue Forecast * Net Sales: product revenue, current and projected [owce Tor ecaee sanRan [HenRae | armas | Morea | BOE YrOne | Yetwo | YeThwe | Yr Four Yerive Wet [390,000 e2z009_s00009 «10.000 350.000 800.000 © Percent Comparison Poa Buaget | FOG Plarvs. | — 002 ve. 2061 | 2009 ve 2002 | 2004 ve, 2003 | 2005 ve. 2008 ve 2000ce | 200005 L F aT Teen vee ae Taal Roche Laboratories, Inc Stncty Configenn 2 2001 Product Strategic Plan for Accutane LR 035087A. Base Case Revenue Forecast ... Continued General Base Casi nue Assumptions: 1. Returns are assumed at 21% of invoice sales each year 2. Chargeback are assumed al 1.1% of invoice each year 3, Medicaid Rebates are assumed at 1% of invoice each year 4. Total oral Isotretinoin market growth is assumed at 0.9% fo: each year 5, The price assumptions are as follows: (IMPORTANT NOTE: Panty pricing at the “per capsuie” level is assumed.) : Ss -xIZ7s 771 10MG 4 $458.30 | $472.05 ZOMG 100's|_s54347_| $659.77 | T 4OMG 100's| $621 47 3650.35 | (raMG 30 $130.21 | Sisat2 | Sie td | S028 | 9145.58 [TiSMG 30's $730.01) Siaae7 | sterse | S142. $145.33 22.5 312856 | Si8242 | $19638 | S1a04E | Sted TO) 30's } Annual Base Case Revenue Assumptions: 2001 1. Total Accutane brand (Current and new formulation)production units increase by 39% (ramp up to maintain inventory levels of 2 MOH) Accutane new formulation is launched March 2001 Accutane new formulation converts 100% from original Accutane formulation (4/1/01 thru 1/31/02) Roche granted Pediatric Exclusivity for Accutane extending patent Ke through 2/8/02 Total Accutane patient increase of 14% Standard 2% annual effect of net price increase occurs Annual contract rebate of 1% 1s assumed. Moonen 2002 1. Total Accutane new formulaton units decrease by 20% due to genenc market entrants (branded and unbranded) Generics eligible to enter market 2/08/02 2. Total Accutane patient decrease of 21% is assumed 3. Standard 2% annual effect of net price increase occurs 4. Annual contract rebate of 2% is assumed 2003 1. Accutane ID launched 4003 (No pipeline fill is assumed) 2. Branded Accutane market converts to ID formulation at the expense(cannibaization) of Accutane new formulation. 3. Total combined Accutane (new formulation and ID) brand units decrease by 20% due to generic market entrants (branded and unbranded) 4, Total Accutane patient decrease of 20% is assumed Rocne Laboratones, Inc. Stnely Confental B 2001 Product Strategic Pion for Accutane HILR 0350888. An estimated annual net price increase of 5% occurs . 6. Annual contract rebate of 5% is assumed 2004 4, Total combined Accutane (new formulation and {D) brand units decrease by 17% due to generic market entrants(branded and unbranded) Total Accutane patient decrease of 17% is assumed ‘An estimated annual net price increase of 7, 5% occurs, ‘Annual contract rebate of 7.5% is assumed : 2005 4. Total Accutane ID brane’ units decrease by 17% due to generic market entrants(branded and unbranded} 2. Total Accutane pation: decrease of 17% is assui 3. An estimated annual net price increase of 10% occurs 4. Annual contract rebate of 10% 1s assumed Roche Laberstones, Inc, Stretly Confcential m 2001 Product Strategic Plan for Accutane HLR 03508904. Business Objectives and Measurements B. Base Case Product Expenses ‘© Expenses by M1 Major Family Strategt Pan “Tne Meeting Planning and Caree! Trammng & Development departments should prowde costs for Launch Meetings and TAD. respecivey Yeu | Pamaian] OTe] Pet] Waseal| oad | Fel] ens) FED | SO] Ferme] Ta Programs| aftars’ | Support | Programs | Meetings! i 0 oat__tarea Fava 730 aia, 342778 Fe Boone | 308 386% oy aaa 1 aa om Yoong oo T0044 Tot 20 7 Tar 3a 770 a Saye, ae, aa] roreg| sa say em 7TH eH A oa Sean Total 200% Teer wore] See aS SS eae ae ey ‘3003 | asad ate 19002000 sere eo e808 25 38} Foo_[ 778 suena F028 ee Po aoe ctr ‘200s | e835 338¢ 370000 zetg a 16.825 16.825] Notes: 4) Direct To Consume: Campargns 2 Mectca! flare ang professional program spending shou te tote spending levels cutimed in tne Integrated Medical ‘The Prmary Care or Speciaty Care Finance Dectar should provide the cost per fild force presentation used to calcuate total 6a force costs, Roche Laboratories, Inc Strcty Contents 25 2001 Produc: Strategic Plan for Accutane HLR 03509004. Business Objectives and Measurements C. Revenue Sources Market Growth ‘Assumption 7: ‘Severe acne sufferers increase by 6% as the DTC campaign creases | awareness of acne ‘Assumption 2: Continued greater morease in the number of new male pavents vs new female patients ‘Assumption 3: “The convenience of once-a-day dosage and lower side effects profile on “mg to mg” comparison of Accutane new formulation vs. Accutane, serves to| facilitate market conversion and provide an overall increase in usage due to the expected improvement in patient compliance, Share Shit. ‘Assumption 7 Continued displacement of Oral Antibiotics as doctors see Detter and more effective results through earier and more aggressive patient treatment with Accutane, Assumption 2 Continued displacement of Retin-A for the treatment of Severe Acne ‘Assumption 3: Value Premium ‘Assumption 7 ‘Assumption 2: ‘Accutane is the ONLY choice of therapy in iis class for the treatment of severe recalcitrant nodular acne. The premium Retail Cost Of Therapy per Day for Accutane has had itle effect on the prescribing behavior. Roche Laboratories, Ic. Stnctly Confoential B ‘Assumption. 2001 Procuet Strategie Pian for Acsitane HILR 035091. Revenue Sources ... continued Roche Laboratones, Ine. Stitly Confidential a 2001 Product Strategie Pian for Accutane LR 03509204. Business Objectives and Measurements D. Variance and Sensitivity - Critical Revenue Drivers ey ery Te | Possibie Rana aan Tor Ra Revere] Catal] ‘Assumplions!| infuence a | "(Year Three) impact | Marking | Revenue Srver| Maree (veartnres) | Intatwes totuabvee : Faamaney | SESE TR The BPE ogra see ony | aH 5S "p Daa A Prevenion eiay ine ety genera toe PRP Kes mandatory part ofthe product} | ' smart shou E become # I label | Rezatane Wew | 7 ORSON Breaucl & hunched Wares ot | “SATWM TO 30» Medea ARES | Pomuaion 2008 and nat Deen the mane | eel | Conversion fora penod of 2 months as of | Rebatee L 103) Physean z THON] Aagressn colaing O's Saree STEIN To Promotion Preserbet erent oy awell Know, | satin SalesForce | | Program | trelhestablehes derm comoay Dect Mai | Con havea signiican negatve | imac Aggressive detaiing By | Roche germ reps (enhanced fei programs plus meentvized teling) can resuttn a postive Die Ae a aoe Faiure to mawtamna areciio | “SATNAESD”p Pant Meda. Campaign ‘consumer campaign when 3 Eiectronc Media| brandeo genere is avaiable the marnetplace wil resut in ‘acomlerates Accutane brand ‘Generar Preauey 3 “Bates | Manian pare wih [SENN Ts peda Arar ‘Suppor ermatoiogets and ne est ofthel +$123MM~ Professional professional omrenty Programs, “Tegenas —~ Seale © Oto 4 wnere O= Least and 4 = Most ‘Roche Laporatones, Inc. Stncty Confer 28 2001 Product Strategic Plan for Accutane HLR 03509305. Marketing Strategy and Initiatives A. Marketing Initiatives ‘Support PPP as a Barrier To Generic Entry | Reference Title: Pregnancy Prevention | initiative Number: 1 L °° Goal ‘The Pregnancy Prevention Program provides a barrier to entry for generic entrants. Additionally the Roche PPP may be adopted by the FDA as a label requirement for al ofa sotretinain, © Descriptio: ‘© Modified PPP kit © Modified Detail Alas © Tactics 4. PPP Update including: Contraception Hotline, and Videotape, Urine Pregnancy Tests 2. CME programs for MD's and R, Ph.'s & NP's 3. PPP update in mult-languages © Performance Measures and Potential RO! Tracking Potential for revenue preservation at time of generic (Branded/unbranded) product launch(es) Roche Laboratories Inc. Strety Confidential 2 2001 Produc Strategic Pian for Accutane HLR 0350940S. Marketing Strategy and Initiatives A. Marketing initiatives ‘Successful Launch and Conversion for Current Accutane to Accutane New Formulation Reference Title: NF Conversion Initiative Number: 2 © Goal Proper and timely conversion to the Accutane new formulation will fkely result in slower generic penetration, when genencs(branded/unbranded) to the “oider’ strengtns are eligible to become available in the marketpiace(2/6/02) Aaditonally, ~a-day formulation, reduced side effect profile on = to mg” basis and "no fo00 efiect” product attributes will serve to increase the number of units through “better” patient compliance. © Description © Medical Affairs '¢ Highlight the key benefits of Accutane new formulation over current Accutane. These would be incorporated as part of the launch copy platform, and thus become essential to the detailing etfort to communicate these key product benefits to the physicians Promotion ‘© Where possible, incorporate the benefits of Accutane new formulation into the DTC. campaign. * Use of Pharmacy CE, Pharmacoeconomic study data and other value added programs in the MC setting. © Rebates © Facilitate prescription coverage by MCO's through contract rebates. © Tactics ‘Some of the tactics that would be incorporated for the successful launch of the New Formulation include: DTC campaign CMEs and AAD Field Programs Field Support Performance Measures and Potential RO! Tracking Qualitative Feedback Primary research Number of Sales calls ‘Tracking on conversion models through prescriptions and sales Track/quantify the number of MCO's with Accutane new formulation on formulary, and without restriction Roche Laperatones, nc. Surety Confiental 30 2001 Product Strategic Pian for Accutane HLR 035095Rocne Laboratanes, Inc. Strety Confoentia a 2001 Product Strategic Pan for Accutane HILR 03509605. Marketing Strategy and Initiatives Re-Emphasize Roche as a leader and the Accutane Brand (including new formulation/D)| as the “Gold Standard” in SRNA Reference Title: Physician Prescriber Program Initiative Number: 3 © Goal 1. To re-emphasize Roche as 2 leader and the Accutane Brand as the "Gold Standard" for SRNA 2. Te successfully auncn tne New Formulation and faciltate the rapi¢ conversion from Ole ormulation © Bescription 1. Promotion. Promote New Formulation through enhanced levets of product detaing and appropriate physician and patient education materials 2. Sales Force: Increased overall detailing effor (Derm rep headcount) to better support the launch of the new formulation re-establishing. Roche as a leader in Dermatology 3. Direct Mail. Provide appropriate patient education materials regarding new formulation(ie. Efficacy, Dosing,, ete) © Tactics 4. Professional journal ads 2. Dermatoiogists' counseling kit © Performance Measures and Potential ROI Tracking Roche Laboratores, Ine. Stacy Content 2 2001 Product Stategic Pan for Accutane ALR 03509705. Marketing Strategy and Initiatives A. Marketing Initiatives Increase Patient visits to Doctor Through Increased Acne Awareness Reference Tith DTC Acne Campaign Initiative Number: 4 © Goal Increase consumer awareness of acne as a treatable and “curable” disease through the unbranded DTC campaign. This will serve to increase the size of the acne market, resuttng in proportional increases in Accutane usage by severe acne patients © Description DTC promotion is the most effective way to increase the awareness of acne. increased awareness has histoncally shown to increase the number of severe acne patients using Accutane. © Tactics 1. Print Media 2. Electronic Media: TV and internet © Performance Measures and Potential ROI Tracking Existing OTC tracking study, that measures 800# callers, (from DTC response) conversion to patient, and eventually to Accutane prescripton, has been instrumental in developing RO! by not only media type, but also by media sources Roche Laboratones, Ine. Stnety Confentat 2 2001 Product Strategic Pan for Accutane HILR 03509805. Marketing Strategy and Initiatives A. Marketing Initiatives Establish Roche as a Dermatology as a Leader in the Medical Community Reference Title: General Product Support Initiative Number: 5 © Goal ‘Support functions that serve to establish Roche in the Dermatology community. © Description Key activities would include certain Medical (ie. clinical trial) and Promotional programs (ie. AAD,DNA Suppor) in addition to other product support activities © Tactics Tactics include, but are not limited to: Grants/sponsorships (AAD) New Formulation Publications Roche sponsored Medical Affairs studies DTC Public Affairs PP&GA Activities oaone ‘¢ Performance Measures and Potential RO! Tracking Roche Laboratones, Ine. Sincly Confidential “ 2001 Product Strategie Pan for Accutane BLR 03509905, Marketing Strategy and Initiatives B. How Marketing Initiatives Influence Decision Makers ‘Size t | Relative | Warkoting intisives | Tactes/Promouonal Ratonare ‘Audience | Importance! Levers and Relative ta tnfvence Importance Patient decides 0 | 7.016 19 OTGAche Campaign | OTC Z| Acne i nat debilitating to ‘seek treatment | ‘the pomnt that one must go to the doctor Patient decides to 9 NonBranced DTC | Accutane isthe ONLY orug asktor Accutane | for severe acne Patient wing © Pa 73 Prong ©] Patents will want genene ‘ut of pocket 1 ore 2| Pabent Subtotal 3a, WO decides to eat 3H 39) Pryscan Prescrmer | Syroosa FIMO undeneais, patenis Program Pupiatons wi drop cut of terapy General Product Phase tiBAV q | Suppo Produ Label | Sates Force Nom Personal Promo 2 WD decides to eat Tay 79) Physcan Preserber | Syroona | Decors may be. ‘worugineame Program Pupacetens oversreating wih system al i anti-boves ‘General Prosuet Phase 1iBaV Support Product Label Sales Force 4 Non Personal Promo 2 TO decides to eat 7788) 79 Paysican Presciber | Syrpose @|_MO sees advariages to with Accutane Program Pubicatins tweating win QDINF Brand General product Phase mes Suppor Product Lave! ; Sales Force Non Personal Promo 2 "Wo Sutiot “a Product ie covered 7+ Gontracied Sales MDS may not wrke Px for easel uncovered patients Roche Laboratories. Inc, Sinctly Confdentiat Eo 2001 Produc Strategic Plan for Accutane HLR 035100B. Decision Makers (more detailed) ... Optional “This optional table provides the opportunity to expand the decision makers (.0. sub-speciaties of MDs, multiple types of payors). Complete the table according to the help provided for the table above Beciaion Wares ‘Sue oF Relative] —Warketing inlatves | —TacticsIPromotional Rationale ‘Audience | importance to avers and relative influence Importance Teaend ‘Scale 0104 where 0 © Least and Include commentary as well as relevant exhibits below. Insert page breaks a8 needed via menu Create > Page Break. Roche Laboratones, Inc Stnety Confaentia! % 2001 Product Strategic Plan for Accutane HLR 03510106. Integrated Medical Strategic Plan ll Roche Laboratories, Ine, Sincty Confential a 2001 integrated Medical Strategie Plan for Accutane HILR 03510207. Base Case Investment Strategy A, Marketing Initiatives Investment Summary Warcetng ‘Dasenpton of Major Expense ATS oT 2007 05 Initiatives: | Investments | Investments | Investments. {Year One) _| _{YearTwo) | (Year Three) Pregnancy PAP ti Unne pregnaney esl, Conacepive Counseling 35.45 $459 35.887 Prevention ana Vseotape NF Conversion ‘avnenn 2001, Pubzaton sien. CME, ANS | sa08 a $2369] RPR Bryan Pesca) prossaal Lava anes MO/Prenteacins ay Bag eased Program toate DTC Acne New Geatve soma a Broadcast ana Prat Meda | sa sr20y son Canpagn space ana interme General Product “Annual AAD convention, Manceing Fisigence acivaes| 35864 5.009 35.564 Suppor Maceal Needs Puble Afar and Pubic Polcy 8 | | Goverment Atta actives % 5 3 { 5 sd { sd sa st 39. sd x0 i Treatment Totals Tae Tae 325.309 Note: ‘This summary reflects tua 8 to's0e total investments and comparisons, Roche Laboratones, Ine. Strety Confidential Case investments, Please refer to Section 10, Marketing iniatives Summary Report 2001 Product Strategic Plan fr Accutane HLR 03510307. Base Case Investment Strategy B. Marketing Initiatives Investment Totals by M1 for Year 2001 Base Case Waiaing | Prowaios| OTe) Prot Weal | Proaua] Fred] Caunch] CHRD” [Sista Fel Fors] —Timatve intatives [Pesren{_ Ate | Siren) ope | wet . ‘ea i | |“ Pragraney| aa co 5a 5259 Proven ‘ 4 1 4 nF Tay La = = yaya Soa Conversion Prysican [270i ay 1 1 7 4 aa Preseroer Progra | ‘Bre Acre | 11840 7a 7 pee TEaR| Caran i | General Ta 3G Seay 29 ras Preavt | | Suen 1 | a | 1 i i 1 a a t i i 1 a aj H i | [4 Meer | ek are sae ae aa: aaa {saa Notes: 1 Dect Te Consumer Compaigns. 2. Medica! afar and professional program spencing shouts ie Io the spending levels outined inthe Integrated Medical Statege Pan 3. The Meeting Panning ang Career Traning & Development departments should provide Coss for Launch Meetings. and CTAD resoectnely, 4. The Pamary Care of Specaty Care Finance Orrector should provide the cost pet fla force presentation used to eateuate total feu fore costs, Roche Laboratones Inc. Stncly Confidential Fo 2001 Product Strategie Plan for Accutane ALR 03510407. Base Case Investment Strategy B. Marketing Initiatives Investment Totals by M1 for Year 2002 Base Case aasas | Farmar OE Fay] Fes] aie] CTD" | SisToa) Fea Fa] ae fener eon] Mom | Some | Pesos] ea] | relies ray] 74 et 7 ay 757 al | 7 om 35H 1am 7am Conversion| | | ener] a ar 78 = Presenter | | Program | + a Rs a5] 7TH Canoe * a a eee ee 7 33} 37 7} a Tm ee j Support, 1 | ik T L L a fama oct t T T t f Farrar} — sant roast rd — pret a at — a et am a flaca te coaneos corsc aan rere caret sregram sperting teu aoe sandy nl etn negra beset Steger oer et nd Cre Trang 8 Cevcpmanteptmers sou prove caer Launch Menge ses chtS ements 1 a Srecs te scan Cre nce Deer shou ove hot all cn ten ned Tennaeiane oe ache Labntoes ne, Snty Content « 2001 Prost Sane Pin fe Acctne HLR 03510507. Base Case Investment Strategy B. Marketing Initiatives Investment Totals by M1 for Year 2003 Base Case AGG | FOGG] OE PS] WR] FRY Fos] RRS STS Fae] =<: [7% ream] Bi’ | S| vane] es fee eee ras] a 7 7 7 =| eset = 7 5 - rm aaa 4 fe) : 74 ei ard a re Tey a7 a ae a ag a | com | a c — 4 t 1 slaaead Ta et ae et et pa 1 Direct To Consumer Campaigns Mecical altars ang professional rogram spending shoul eto the spending levels cutined in the Integrated Mecieal Strategic Plan 3. The Meeting Planning and Career Training & Development deparments should provide costs fr Launch Meetings sn6 CTAD,respecivesy 4. The Prmary Care or Specialty Care Finance Ovector should provide he cost per fla force presentation used to caeulae total Hels force costs Roche Laboratones, Inc. Stictty Confdental a 2001 Product Strategic Plan for Accutane ALR 03510607. Base Case Investment Strategy C. Marketing Initiative investment Rationale iarketing initiatives Rationale Tor Investment Level (Revanoe Driver Effect, | Timing to Return] § impact on ‘Supporung Data, Analogs) (Ron Later Year i [Funding Pregnancy Prevention Though voluntary the FDA may requre PPP Greater PPP inmesi 34 | spending may provige Barrer te generc-spending, nus, | soending is essenualy requred NF Conversion | Physcin conversion wil resut m slower genenc erosion Trsmeciate and 312 | _Stein tina maa, Sastre tt ean) tonger term sil drive 2016 new formulation conversion yeas) Physician Prescriver | Sceng needed for physicamn detailing, Essentialto Tmomecatel $10,000) | Program | teremphasze Rocne oermatology franchise as aleacer, and I! | tRetAgsutane Brand os the Gols Standard in eating SRNA. ‘BTC Acne Campaign | Histoncal Accutane gata (DTC ROI Analysis) shows strong Wear ane 335.00 {tiahonshp between DTC spending and unt sales Miter General Product Suppor] Essential to r-emphasize ine Roche dermatoogy franchise as Near ane 374.000) 2 lnader in the professional Dermatology commrunty Longe i T Tout $269,000) Roche Laboratories nc, Strictly Confdential a 2001 Product Strategic Pan for Accutane HILR 03510707. Base Case Investment Strategy Marginal Investment Impact Wiarketing Inliaives]| Reistive impact] Max Case Ralionale | Relatve Impaei] Min Case Rationale ‘of Marginal | ‘of Marginal Increase | Decrease Pregnancy 7 Tnareaae 6 PEP Span wit 0 PED spenang cannot be Prevention ‘only be oenefical FOA reaucea ‘makes PPP a labeling requicement for al sotetnon Asa labeling requirement, PPP can serve as an effective, tamer to gelay generic erty. | thus adeiwanal spend could be uses NF Conversion z Conversion io NF an 7 Conversion MUST occur BST aggressive goals 2 relatively toavatabiy of genene short bene Fame athe Ibandeslonorardes) ‘curent spend evel 'sotretin in he marketlace| Physician Preseriber z Doubling of professional | 2 ‘Doubing 2f professional Program ‘tating ove: 2000 level is etaiing over 2000 levels necessary to efecively and | necessary © aunch the New ‘apy aunch the New Fermuaton of Accutane Fgrmulaon of Accutane BTC Rene Campaign 2 ‘nereated patent posi] 2 Decreased paver pos! ‘General Product Wamtavbaid repove win 1 > ‘Wairian repore wi ‘Support ermatoiogists andthe rest of ermatologsts andthe rest of the professional community ‘he professional community r t Roche Laboratones, Ine. Sinctly Confidential ry 2001 Product Svategie Plan for Accutane HLR 03510808. Max Case Investment Strategy ‘A. Marketing Initiatives Investment Increase Summary Harting ‘Description of Change and Rational for Wax Lever Too W008 7005 Initatves Aavestments | investments | favestments (Year One) _| (Year Two)_| (Year Thres) Pregnancy Fox may wane PPP az pan al walsovetnen 34 3187 sa) Preverton lapeting. wich may serve fo delay market ery ct a fenenc compettor ncuson of the PPP a8 3 being fequremert fra oa fcteenon serves otto cetend ‘Acetare revenues ate yee of Re combelive lan (2002) NF converson Rape NF rae converson (re adeauale personal 6 mat sag Seling otoessional promotion, C E. ana publeatns) | ‘tsental or preveverg te revenue steam ure years ryan Preseiber| Augments mane! conversa 0 NF (001-7002) ana Fr Es a7 Program Continues to estabish Roche ag a leaderin dermatology I DTC Acne irereaued DIC spending serves to ve more untreated 3188 For 31069 Campaign favents to the patent pool resuting larger paert base for Acewiane ‘General Product ‘Supports key activaies to facilitate the conversion of | sare ‘sia ‘s215| Support ‘current 19 new formulation, | so EI x [ ‘sd ‘sq Fa so EI x 1 sd sa 30 Teventmont era wey asd Far Now: ‘This summary reflects an Increase from Base Case, not total Max investments, Please refer to Section 10, Marketing Initiatives Summary Report to see total Max investments and comparisons. Roche Laboratones, Inc, Sincty Confiaerta! “ 2001 Product Strategie Plan for Accutane HILR 03510908. Max Case Investment Strategy B. Marketing Initiatives Investment increas: by M1 for Year 200t Max Case: Increases from Base Case RES RRB eee fe tt Cals fc [esd sae | Som] ner | =| eae ee ea | - Pe El ea sone a } oa a alii | etm i mete a Se 5 sa eo | }—J — — 4 : = weap = am Direct To Consumer Carnpaign. ‘Medical aftars an professional program spending should te tothe spending levels outined inthe Integrated Medical Strategic Plan “The Meeting Planing and Career Training & Development departments should provide cass for Launch Meetings and CTAD, tespecively ‘The Pnmary Care cr Speciay Care Finance Director shouls provide the cost per fell force presentation used to calevate total etd force costs, Roche Laboratones, inc. Stretly Confential 6 2001 Product Strategie Pia for Acotane HLR 03511008. Max Case Investment Strategy B. Marketing Initiatives Investment increases by M1 for Year 2002 Max Case: Increases from Base Case ay RET BT POE TE PTO || en |S ee) feo Ey 5 1 “ roo, 21s Ei =m j oe = +— . re | ie | ta i mi a | =e 5 T r T T T : sat aa t= : za See ie acres elle at insite 4376 CTEO, respecively ‘The Pnmary Care or Specialy Care Finance Drector should prove the cost per field force presentation used to calculate total Ged force costs Roche Laboratories, ine, Strety Content “6 2001 Product Strategic Plan for Accutane WLR 03511108. Max Case Investment Strategy B. Marketing Initiatives Investment increases by M1 for Year 2003 Max Case: Increases from Base Case wariaing | Fromaien| BTS] Pa] weseat]| Promuct| Fas) cavnen] TED" | SoBTotat Fed Force] —iotaine inwauves | [pega Afar’ | Siepot | Prams Nesirg Pee maces Freararey cc 7 74 73 7A Provenion | Sr E z 74 3 3] Conversion | Frys cr 7 3 FF Ea Preserber i Program are Ace | THF + 7 —F Toa 559 Ceroeen | i Genet 7 aa 7—F FF aq Procuet | I Fane Suspor_ | it t | cc a G 1 I t t isan cI J i i | i i i— a 7 | i | | ese) a gl co Ty 5 ia TH Testes piuecian Se) eet see] ee Note 1 Direct To Consumer Cansagns 2 Mecca! afar and protessonal program spencing shouts tie othe spending levels autined nthe integrated Medial Statege Plan 2. The Mectng Pannng and Corer Traming & Development departments shou provce cost for Launch Meetings an GT8D, respecety 4 The Prinary Care or Specaty Care Finance Orector should provide the coat per ft ote presentation used 1 alent ot ela fron cost Recne Laborstones In. Stacy Confaental a 2001 Product Strategic Pan for Accutane HLR 03511208. Max Case Investment Strategy C. Revenue Impact of Max Case Investment oF 7002 cd oA] a0 YearOre | _veurtwo | veurtnres | vearrour | _vaarFive [ Tas Bae Case vere 447 000 SoOooB_—-aT0000 350 E06 | ana Tor Ravers Crane Marketing | Estimate Intesver | (Revenue Dever Efect Supporting! Max Case Revenun | Dats anos) ragransy | FOR ay are PPP as pao 7 aa Prvcnnoy | orebnomiabeling whch ay seve ‘Seay manetenty oa gene Somoctian as san PPP the el | Sonar cetera acctne \ | fSrenes omymineyearetibe |__ Sowa aunen 2030 TE Carvers | Rana nr atk Conese 5S x 5 Saco Gres of eraort sig. | serena pemevon, pabieatore i | Soc} essen tr bresereng L Aare yar rerun steam [Banca agen re mae conversa 7 3503 x 709 Proneme- | Nt lgoal2002 an comances © Progra Ceuoemn noone ar encore Sermatsogy SiC Rene | —Insenseo OTC ag seve om 75) 7309 Saroncn | Sve mare rests paver the pavent poo esong fa ager l Sater bese aceane Se a a a 7 Storer conversion of eorenio new ‘Smaaton t t a a CC i Tal War Case reverse! 63.008 553.000, 438.009 s6a.00q__ a0 Roche Laboraiones. nc Sty Content “ 2001 Preset Sate Pan for Acstane HLR 03511309, Min Case Investment Strategy ‘A. Marketing Initiatives Investment Decrease Summary Waring Desert of Change and Rationale Tor Min Level 08 WOOF Tia Iniatives Investments | investments | Investments (ear One) wTwol_| (Year Three) Pregnancy BRP a a arver of evenue preservation and NOT 5 Ex 3H Prevention revenue expansion NF Conversion ature to prove adequae evoirengt9 conven fom a Be Carrent formulation o new fomulavon rapt wil traniost a 9 sgeteantrecuchon i revenues ne years Pryaisan Pescrbe] Reavangexpandiures me area sven 1 counter a = 3 Program {apo conversion 1 NF ans weakens te Roce tranenae goat a 9 onde” dermatlogy DTC Acre ‘CLs maoe rs ener years eauces overaleent aa 70d 784 Camean Scotng autem pl prooucng tne ost Tamale eect Sn eon yertevenves (2004-2002) when brand erduiwy exats ‘General Prosuet Cuts mace durag conversion new formualion Pave Fr Fr 353 Suneort the mon sgnteart effec ine carer year 0 Fr EI sa so] sq sd $0) sf sd 30 Tiveetent Decraarr Bay sac Tsed Note: ‘This summary reflects a Decrease from Base Case, not total Min investments. Please rafer to Section 10, Marketing Initiatives Summary Report to see total Min investments and comparisons. Roche Laboratones, Inc. Strictly Confaentit 4 2001 Product Strategic Pan for Accutane LR 03511409. Min Case Investment Strategy B. Marketing Initiatives Investment Decreases by M1 for Year 2001 Min Case: Decreases from Base Case Warkesng | Froncion] OWE |Past] Waseat| Fiona | Fed | cninch] ~CTES™] SubTaay Faw Face] Tans Iniatives [page| ate! | Sit | Pov | eg 7 osreares ; lie Pregnancy ayy 7 ap 7 Prevenson i 3 a 4 3 7 75 Conversion Prysean cs am 3 a wl Presener Program i Drea ya 7 Tz 7 Samoan | Genet 7 77 a F 7 row Suppor _ | | i t T i T of t t cI wit 135 r 284] a 343s 1333 3a Decreases ieee eae] i as | Notes: 1 rect To Consumer Campaigns Medica’ afars and pretesional program spending should ie 1o the spenskng levels outined nthe Integrated Meal Svategic Plan 3 The Meetng Paanrng anc Career Training & Development depanments should prove costs for Launch Meetings and CTAD, fespecivety 4 The Primary Care or Specalty Care Finance Dector should provide te cost pet fies force presentation used 12 ealeutate ola ed force caste Roche Laboratories, ne. Sinetly Confidential 50 2001 Product Strategic Pian for Accutane HLR 03511509. Min Case Investment Strategy B. Marketing Initiatives Investment Decreases by M1 for Year 2002 Min Case: Decreases from Base Case — poe] Met | Sore] Pere |e] || | Sem Poe] “| ‘ = i a 33 7 a 1 Preseriber Program = oe i : mo] | feat = | Te Aen ca ae 700 7 canoe ea { 4 | Genaral E a a 0, % 3 Proave | | Support i 1 a T 1 at 1 i a I 1 al 4 i Notes: 1 Dect To Consumer Campagne. Mecical afar anc professional program spending should te tothe spending levels outined in the Intgrated Medial Svategse Pian 2 The Meeting Planning ane Career Trang & Development departments should provide costs for Launch Meetings and CTAD, respecively 4 The Prenary Care o* Specialy Care Finance Diector should provide the cost pe fll force presentation used to cate fla fed fore 2251s Roche Laboratones, Inc. Strely Conficent st 2001 Product Strategie Pian for Accutane HILR 03511609. Min Case Investment Strategy B. Marketing Initiatives Investment Decreases by M1 for Year 2003 Min Case: Decreases from Base Case Warcaing | Pansisn] OTe] Pot] Maes] Proouet| Fee] Launch) Cra” |SibTaa] Fae Fos] naive Initeves eam ace | Setson) Povame| Hea TO) ceases Pregnarey| z x a cc 3 Paves (EES ae EEE Bee) WF z 7 + a a Converon | | Pryscan a 3 aH ay Prescrber | | Pregrr | | OTe Rene 7a a oar 375] Eanoson | ‘avers 3 a 5a eS row Suppor i 1 T 1 El 1 7 T r { o} eae 3 | a Sy = q 5 aaa] 1 Direct Te Consume: Campaigns 2 Medica atfars and professional program spending shoul be tothe spencing levels cutined in the Integrated Medical Svatege Pian 3 The Meetng Planning and Career Tramng & Development depanments snouts provi costs for Launch Meetings n6 CTED. respecively, 1¢ The Primary Cave of Specotty Care Finance Drectorshoula provde the cost per felt farce presentation used to calculate ota eld force casts RRocne Laboratones, ine Stnetly Confsental 82 2001 Produet Stategic Pan for Accutane ALR 03511709. Min Case Investment Strategy . Revenue Impact of Min Case Investment 7007 Eo F005 7008 70s Year One | _YearTwo | YearThrve | YearFour_| Year Five [es Toul ease Coes revere! ——s22000 Son oi «i0.000 350.008 — 300.000 ationale for Revenue Grange Martoting sumac fntiatves. | (Revenue Driver Effect. Supporting Min Case Reverve Dea, Analogs) Pregnancy BPP aa der at everue a 5 Prevention | preservation ang NOT revenue 1 AF Converian | Fare to sone saoaate reseurong) 800] SEG Ta0GA 5. TEae to convert rom curent frmabon 0 1 ‘new formulation rap wit mantest { 159 signet eaucton n revenves intiaure years Payne Reducing expenataes mths wea 73 Tam 730 Ta z Preserser serves 19 counter the rape conversion | Programe TaN anc weaters tne Roche francnse oenton aso eadern Sermatoiogy Tie Ae Cuts mace eae yeas FeGucRs Ta Tose 30H 3 m9 Campage vera exmentseoung tert poet 1 Drouin te mos! erratic ae on | the earser year revenues (2001-2002) | van brand exclswiy sts ‘Genera Prada] — Cuts made dung conversion ew aaa = Er 3 Support ‘omulaton have te most sgnicant fecin the garter yours i 1 i r i t + t “aia revenve change; 7ea00) __es.600) 311000, —~zasp0q 33000] Total Win Case revenue! 646.000) 451.0001 370,000.32 277209} Roce Laboratories Ine. Stnctly Confidential Ey 2001 Product Strategic Plan for Accutane HLR 03511810. Investment Comparisons and Resulting Revenue ‘A. Comparison Report by M1 for Year 1 D).seccs Roche Laboratories, Inc. Strety Confeentiat 5 (Untied) ALR 03511910. Investment Comparisons and Resulting Revenue ‘A. Comparison Report by M1 for Year 2 Ela Roche Laborstones, Inc. Stretly Confidential ss (Untties) HLR 03512010. Investment Comparisons and Resulting Revenue A. Comparison Report by M1 for Year 3 DY seca Roche Laberatones, Inc. Stictly Confisental 56 (Unttied) ALR 03512110. Investment Comparisons and Resulting Revenue B. Comparison Report by Marketing Initiatives for Year 1 Dsecew Roche Laboratones, Inc. Sinety Confidential 7 (Unites) HLR 03512210. Investment Comparisons and Resulting Revenue B. Comparison Report by Marketing Initiatives for Year 2 D secon Roche Laberatones Inc. Stnctly Confit 8 (untties) ALR 03512310. Investment Comparisons and Resulting Revenue B, Comparison Report by Marketing Initiatives for Year 3 D sccm Roche Laberatones, Ine. Sincly Confidential 59 Wnttieg) AILR 035124I. Alternate Environmental Scenarios A. Primary Scenario f Total Revenue 2007 2002 BOT t Implications (Year One) (Year Two) ‘Year Three) Min i Ta Baia $578,005) Base $622.00 3500.0 470.000) Mae 3563. 3533 546.009) Total Investment FooT BOF 05 Implications. in sia S575 see Sa ‘70.651 525. t 339.085) $32.11 ‘S77Z23) Roche Laboratories. Ine. Stretly Confidential 60 2001 Product Strategic Plan for Accutane HLR 035125Appendices - 1. Required A. Product Data © Objects/Rich TexvAttachments. Roche Laboratones, Inc. Stncty Confidential 6 2001 Product Swategic Plan for Accutane HLR 035126Appendices - 1. Required B. Product M1 Data © Objects/Rich TextAttachments 2 FDA Budget 2000 Other Sheets: x) : a} Please note thatthe M-1 has been revised to include a DTC section, with accompanying categones and detail elements. Please restate your 2000 Budget inthis new format for the 2000 LE if you budgeted DTC expenses, if you have not Budgeted DTC expenses, leave this section blank and provide changes for the other categories of expenses. x} ‘The worksneets above are aigo provided as atachments below inthe event that your computer doesnt have suffclent memory to process the OLE objects Cick on the aiachments and detach them te yout hare arwe You may then open them in Excel, ‘Keep in inc thal wnie changes mage to OLE objects ave saved back into NorthStar attachments are separate copies so any ‘changes can be saved inte warksneet but you most manually put them info NorthStar Mf you make chaniges tothe Wworksheeis ang you wish those changes tobe slored in NohStat and visible fo others, you must re-atached the worksheets ater you nave saved your changes. ToGo this, select Fle > ARAN whve edtng tis document Sec! the worksheets from your hard ve Accutane3 x!Soqce.dget saved 2728, Accutane2.xls.ooo.e saver 3°29 Roche Laboratones, ine, Stictly Confcetit 2 2001 Product Strategic Plan for Accutane ALR 035127Accutane xls001 m1 saved 129 Roche Laboratones, Inc. Stnetly Confdentit 3 2001 Product Strategic Pian for Accutane HLR 035128Appendices - 1. Required CC. Product Strategic Plan Fin'l Summary © Objects/Rich Texuattachments xj Roche Laberatones. Inc. Strictly Confisentia! 64 2001 Product Svategic Pan for Accutane HLR 035129Appendices - 1. Required D. Patient Driven Forecast * Objects/Rich TextAttachments Patient based forecast Roche Laboratones. Inc. Stietly Confident 65 2001 Product Strategic Pan for Accutane HLR 035130Appendices - 1. Required E. Market Research Plan © Objects/Rich TextAttachments Roche Laberatones, Inc. Sticty Confental 66 2001 Product Strategic Pian for Accutane HILR 035131Appendices - 1. Required G. Infrastructure Resources © Objects Rich TextAttachments ) wa. ‘Roche Laboratones, Inc. Sincly Confiaenti o 2001 Product Strategie Plan for Accutane ALR 035132