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The document discusses the challenges faced by Deborah Dunsire, M.D. as she aimed to lead Millennium Pharmaceuticals towards profitability after her interviews in January 2005. It provides a historical overview of the pharmaceutical industry, Millennium's founding, and its evolution through strategic alliances and acquisitions, highlighting the company's rapid growth and subsequent challenges. The narrative culminates in the restructuring efforts initiated by Levin in response to financial losses and market pressures in the early 2000s.

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9 views22 pages

Cssi

The document discusses the challenges faced by Deborah Dunsire, M.D. as she aimed to lead Millennium Pharmaceuticals towards profitability after her interviews in January 2005. It provides a historical overview of the pharmaceutical industry, Millennium's founding, and its evolution through strategic alliances and acquisitions, highlighting the company's rapid growth and subsequent challenges. The narrative culminates in the restructuring efforts initiated by Levin in response to financial losses and market pressures in the early 2000s.

Uploaded by

goitrishi07
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© All Rights Reserved
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Ng HARVARD|BUSINESS SCHOOL 9-710-415 EV; APRIL 26, 2010 yuuie wuLF SCOTT WAGGONER Organization and Strategy at Millennium (A) ‘As Deborah Dunsire, M.D. returned home from her January 2005 interviews at Millennium Pharmaceuticals (Millennium), she ran through her assessment of the challenges she ‘would face at the Cambridge, Massachusetts-based biopharmaceutical firm. As a potentia] success to founding CHO Mark Levin, Dunsie’s first priority was to bring Millennium to profitability: To succeed, she Knew that she would need to rapidly establish a productive relationship with Millennium’s management team. Among other things, the team would need to reevalu'® the number of disease Classes Millennium could feasibly tackle and to determine how the firm limit cases ta across the value chain activities of early-stage discovery research, later-stage drug wand final product commercalization. Dunsire would present het initial plans for Stiteezium to the board on Monday morning, Sitting in her living room, she pulled out a legal pad and began to jot down her thoughts. A Brief Background of the Pharmaceutical Industry juts se wae of betbn apd other ramedies Yo vest allman dats back © micent Oo ‘modern pharmaceutical industry can be traced back to the ‘nineteenth century. For example, while Searching for a malaria drug in 1856, William Henry Perkins ‘synthesized the first synthetic dye, heralding a new era of chemical-based drug development. Subsequently, Louis Pasteur helped move germ theory and vaccination ‘reward, Bayer AG released a popular Aspirin product and Bert Ehrilcn developed the first antibiotic to treat disease. During the first half of the twentieth century, many chemical firms branched into the growing ‘pharmaceutical industry and governments implemented increasingly stricter industry regulations? double helix) by Francis Crick and iif in the pharmaceutical industry that would offer The 1953 discovery of ‘of the value chain (see Exhibit 2). In the James Watson foreshadowed a paradigm vntial to unlock value in the early-stage discovery = early 1970s, Herbert Boyer and egaes : gers piotechnology drug, Humulin, a genetically engineered pi9ga2 Despite the industry's promising 5. he science was ever more complex { envisioned, and by 1988, the U'S. government had approved only nine iotechnology drugs. in details have ben dagloed. HBS cases are deveoPeS stration of effective oF Organization and Strategy at Millennium (A) nosis 4 biotechnology firms emerged as the felds of biology and hnology Frese in mapping the DNA of the human its made significant Propie on finding chemical compounds to ogy fem used biology t0 identity biological targets ant or cure these diseases. Up to that point, the '500 drug targets and experts predicted that new drug targets while increasing efficiency aretpoctening the cost and time to develop drugs.* if : sy et as slo a period when the traditional chemical-based pharmaceutics a amet we Ea ug pte eae competion 0 SEES Sos oe industry and falling productivity in the increasingly expensive and eid es iS 12 Ses 3 Indust frenityentinated thatthe cost ofan average marketable QW6 WAC °F million Tull tut the ine between inital development research and mavketng hhad grown to 10-15 years* Experts petery one in 10000 molecules in discovery became a marketable drug and only are erstetd droge generated revenues that exceeded theis RED conta’ 10 response to thee dynamics, cud Be teramnbled to form research partnerships with the most promising iotechnology firms, such as Millennium. ‘The Founding and Evolution of Millennium {in 1983, Levin founded Millennium Pharmaceuticals in Cambridge, MA with a group of top-tier rescarchers. Levin, a biomedical engineer whose principle experience was outside academia, ran Genentech’ process engineering in the 1980s, co-founded Cell Genesys in California and was 2 partner atthe Mayfield Fund, a California-based venture capital firm, where he founded nearly a dozen businesses. E Levin's founding team included Daniel Cohen, M.D., Ph.D. (a professor at the University of Paris ‘and co-founder of France's Centre d’Etude du Polymorphisme Humain*) and Eric Lander, Ph. ‘of the Whitehead Institute/Massachusetts Institute of Technology Center for Genome Research’), who were key players in competing projects to first map the human genome ‘Additionally, Jeffrey Friedman, M.D. was performing obesity research at Rockefeller University and ‘Raju Kucherlapati, Ph.D. was a professor at the Albert Einstein College of Medicine. To launch Millennium’s operations, Levin raised $8.5 million in seed financing from venture capital firms Mayfield Fund, Greylock Limited Partnership, Venrock Associates and Kleiner, Po:isns, ‘Caufield & Buyers” In 1993, Levin became Millennium’s interim CEO, an interim that laste! watil summer 2005. Phase I - “Build it and They Will Come” (1993 to late 1990s) Inthe early 1990s, as the fields of genetics and information techn i 3s in ' ology rapidly evolved, Levin ‘envisioned combining these fields at Millennium to, “address diseases at their root causes, rather than simply identifying and treating their symptoms.”"" pe eee Fi ori Levin hired top-tier university researchers and medical doctors, from places like neighbors Harvard and MIT, to merge their expertise in such areas as genetics, roe ‘chemistry, robotics and computer systems into a state of the aft “technology platform.” Millennium’s technology plato essentially combined hard sciences with powerful computer systems and industrialized the “°° discovery process with new tools such as proprietary Rapid Analysis of Differential Gene EXP" (RADE) technology, large scale DNA sequencing nd high throughput expression clonins: Je @ _ > > 5 = ~) > = = > S = =) > > > > > —> » “ E ly improvi y "Mark's vision out® the speed, effectiveness and cost of drug discovery. As one executive surmised, Millennium’s harmace logy platform hel frm leapfrog. most other biotechnology and Pig ACCtical ms in eay-sage drug eget eae tad Dilogial molecules within the eo ie diseases). By 1995, Levin was leveraging the firms vision and tee Agreement, Mane states aliances with major pharmaceutical firms. In a typical Sets Partner would. pay Menus cary out early-stage discovery research and the pharmaceutical Fesearch wile Pay, Millennium an upfront fee, make milestone payments when & pre-specified aed comets Was achieved an take esponsibility for potential downstream drug development Millennium ma; market by discs nimized the value ofits technology pltform by segregating the pharmaceuticals area (such as diabetes, inf into simultaneous epee lammation and oncology) and entering into sim Maearanc! Partnerships with many firms, narrowly defining the scope of each alliance, For example, Seay tis alliance was a $70 millon dolla deal with Hoffmann-LaRoche t search ony for rights inciuatne aan ae targets over a period of five years. Millennium retained a wide variety of Detar eit ip of any discoveries outside the scope of the agreement and future drug Millennium’s ability to negotiate research alliances became san lity ton rch alliances fa key driver of its competitive ne age. By September 1998, Millennium had formed over a dozen alliances and had just entered the largest discovery alliance in the history of biotechnology. Millennium’s $465 million agreement with Bayer included a $100 million equity investment by Bayer in the firm. Over the subsequent five years, Millennium would collect $365 million for providing 225 drug targets to Bayer in, the therapeutic areas of hematology, ver ren, oncology, otnpord pain ad viral ctions.* Millennium was so successful at forging alliances, that it eventually collected some $2 billion from its partners. These funds helped Millennium to build a world-class research platform with over 1,000 scientists performing cutting-edge work in some ofthe most challenging therapeutic areas including: asthma, autoimmune system, cardiovascular, central nervous system, inflammation, oncology and ‘obesity (see Exhibit 2) With respect to alliance opportunites, Levin commented, “When people walked in (offering) $25 Ee ttien up front and $200 or $400 lin, not guranteed but lkaly fo ba meses future, we took them on. . Wes hard to tell when to stop when you have that kind of demand. On the other hand, however, they did bring in a tremendous mony Otay and what ta alowed to do was to build our own (downstream) pipsine, ‘which cost well over a billion dollars. SVP of Corpor in discovery was rapidly in the market and privately sponsored Organization and Strategy at Millennium (A) oats jing, of the human genome, moving biological wore completing «preliminary TP Eotechnology firms, t0 the public domain. Levin a ton, Ts ingly clear that in the ‘medium-term, the human genome would be ‘ecalled that, “Tt became incre public ot with no value. So looking forward three, four of five years, ‘and would either be publi of Wtory.”1® Consequently, Levin began to steer Millennium you Wow alliances (upstream) and towards drug development and away from early-stage disso™Y fe Exhibit 3 summarizing the evolution of Millennium’s in’s new strategy, Millennium pursued a series of acquisitions, Tone end pe eg, en ci According fo Manic growth would be too time consuming and difficult, so we concentrated on paths, we felt GTBNibit 4 showing, selected acquisitions). Millennium’s first significant move Men escom drug discovery research to drug development was the 1997 acquisition of doweiige, MA‘based ChemGenics Pharmaceuticals for approximately $90 milion in stock ChanGerics provided high-throughput screening capabilities for developing drug targets into lead Grrpounds, ‘The deal also included alliances with Pfizer covering antifungal treatments and ‘Anierican Home Products (AHP) covering bacterial diseases." In October 1999, Levin announced the acquisition of Cambridge, MA-based LeukoSite for $750 million in stock. LeukoSite provided Millennium with downstream development expertise in areas such as chemistry, clinical trials and regulatory affairs. It also contributed an oncology and inflammation product pipeline, with six drug candidates in clinical development and over a dozen drug candidates in pre-clinical development, including one candidate that Millennium would eventually market as VELCADE® (bortezomib) for Injection. Millennium appointed Christopher Mirabelli, the former CEO of LeukoSite, as President of Pharmaceutical Research and Development although he resigned in April 2000. In many ways, 2000 was a highly successful year for Millennium. Levin expanded Millenniun’s strategy to include “personalized medicine,” which he envisioned would leverage Millennivim’s technology platform to customize medicines to the genetic profiles of each and every patient. In Levin's view, personalized medicine held the promise of improving the effectiveness of -Irug treatment while limiting side effects. The firm also acquired UK-based Cambridge Discovery ‘Chemistry (CDC) for $50 million in cash. CDC bolstered Millennium’s downstream drug development skills in medicinal and computational chemistry, adding nearly 100 chemists who would help to bridge the gap between early stage discovery research efforts and marketable drugs. Millennium signed a $450 million alliance agreement with Aventis and was progressing towards @ $250 million alliance with Abbott, which was signed the following year. Millennium’s vision and rapid evolution made it the “Darling of Wall Street” as investors drove the company’s stock price up more than ten-fold, pushing Millennium’s market capitalization to $18 Billion by November 2000. By way of comparison, major established pharmaceutical firms such a6 Schering-Plough and Pharmacia were valued in the $70 billion range at that time. In 2000, revenues for the three firms were $196 million, $10 billion and $18 billion, respectively. In any case, ston investor demand that year permitted Millennium to raise over $1 billion cash in the public marke and to use its highly valued stock as currency to acquire other businesses. To some, it seemed #5 f Millennium had no resource constraints. Fanuicci commented, “Visionary leaders are not necessarl} disciplined. It would be too constraining,” a San In 2001, Millennium announced the $3 billion acquisition of COR Therapeutics oe it biopharmaceutical firm with approximately 300 employees and over 1 Ts cted annual profits. COR owned INTEGRILIN® (eptifibatide) Injection, a successful 4 renin 99 terra or ua on Prot. Muero's PGOA GMP 202-26 | Term Millennium’s R&D organization from more productive opportunities. So when the me) E Phase Il clinical trials management established "go/no-go” criteria. The criteria stipulated that f he . drug did not drop levels ofthe relevant biomarker efficacy by 50% in a set number of patients, {ne the clinical trials should be terminated. Unfortunately, ater the trials were completed, it became clear > that Project 241 did not meet these criteria. x Millennium’s Portfolio Review Committee (PRC), whose membership included the senior level > R&D team, reviewed Project 241's Phase II clinical data, commercial feasibility and financial ‘projections and concluded that the project should be terminated. The PRC discussed its conclusion ‘with the Executive tedm, which requested a formalized presentation. In the meantime, individual ‘members of the Project 241 team who were champions of the’ molecule, initiated parallel discussions with individual Executive Team members to lobby for the continuation of the project. Continuation of Project 241 would require significant additional investment by Millennium. Despite the PRC's recommendation, Project 241 continued. Incentives > > ) P > Millennium’s human resources practices were focused on fostering a creative, entrepreneurial environment in which employees were encouraged to extend themselves in terms of work load and iD content. Executives emphasized social gatherings and creating forums for the exchange of ideas, always with the goal of making work feel like fun. Few human resources policies existed and fewer b> ‘were applied consistently across groups. Management discussed processes but often abandoned them to accommodate individuals. Millennium had a relatively informal employee review process for many years, However, employees were not consistently required to prepare formal goals at the beginning of each year, making it impractical to hold them accountable at year-end. Because annual goals were not documented consistently, compensation was not necessarily tied to performance. As a result, compensation was generally doled out relatively equally to employees across a level, creating a narrow dispersion. A Human Resources executive added, “It was tough to rank top-tier, valedictorian-type talent, so most employees received good reviews.” In general, Millennium’s employees were compensated well which kept them from complaining about limited pay differentiation. However, for some, it created a lot of frustration because “compensation awards were more the result of relationships within the firm rather than achievements,” Over time, a lack of recognition tended to de-motivate the firm's best performers and 2 lack of accountability failed to motivate the underperformers to improve. Millennium’s ‘executives recognized this central tendency problem and developed more organized goal setting and 7 or use ony in Prt. neat Mustarje's PGOM GMP 2025-26 | Term I: Corporat Satogy and Satgy plementation (CISSIG25-3) at Xavier Labo, eelatone neta (AI fom Aug 2028 Feb 2028. ‘etwing the bua ofthe technology bubble in 2001, and the subsequent i ‘Things changed i ions (and related stock aries anBet price The value of previously granted employee stock options (Oh ToT te, sained through option redemptions) fel significantly, negatively impacti0g z cbtainet A This fll also dampened employee enthusiasm for future option Grants, according employee surveys. o Levin migrated Millennium towards the compensation model used in the more matt Stevie lc rs cm we ang Pa he ims stock option programs. By 2005, Millennium was also considering adding a restricted Sock program. At that time many US. firms were also modifying their compensation packages in response to changes in accounting and reporting requirements. ‘Although compensation was important, firm-wide surveys indicated that Millennium’s team was also driven by a variety of other intangible factors, such as the ability to help patients, to work with oes © 9.9.99 Sree ‘of knowledge.” According to Joe Bolen, Head of Oncology Biology at the time, “Quality of science ‘and top science reputation mattered more to employees than compensation.” (see Exhibit 10 showing 2005 employee satisfaction survey) Leadership As Millennium migrated towards downstream drug development and commercialization, Levin ‘came to the conclusion that the firm needed a different kind of leader, “someone who was passionate about making a difference for patients, had big pharma experience but was excited about leading an ‘entrepreneurial team, and had tremendous commercial success.”** In early 2005, Levin met with Dunsire, a medical doctor by training who spent some of her early career practicing medicine bu’ found her niche in drug commercialization, launching nearly a dozen products during her career. A‘ the time, she managed Novartis International's $2 billion North American Oncology Business Unit He subsequently reflected, “It was a perfect match.” Situation in the 2004 Timeframe Despite restructuring, Millennium still spent $430 million in R&D and booked a $252 million loss in 2004, bringing net cash reserves well below $600 million. The company had narrowed its development efforts to cardiovascular, inflammation and oncology and was focused on transforming its early-stage contract research business into a vertically integrated biopharmaceutical firm. or use onty In Prof indrajt Mukherjee's PGDM GMP 2025-26 | Term - il: Corporate Strategy and Strategy Implementation 5.) atxove? ‘Relations Institute (XLRI) from Aug 2025 to Feb 2028. — em Organization and Strategy at Millennium (A) reais Millennium also was commercializing two products, Veleade and Integrilin. Key functional leadership challenges needed resolution to make the vision a reality Commercial Efforts As blockbuster research partnerships became a thing of the past, Millennium became increasingly anoles een tena qe Ruts ann ‘was to move from a pure science mindset o one where commercial functions had similar respect and voice. Fortunately, the firm's oncology drug, Velcade, was proving to be one of the most effective treatments in its space and was les expensive than its leading competitor. Millennium’s managers also believed that Velcade had significant potential for growth through label expansion into new treatment areas, Protopapas observed, “While we launched Velcade successfully... the reality was that the sles of Veleade in the U.S. were lagging behind our growth expectations... Part of it was a biotech company, primarily science-based, really trying to become a commercial company. And we launched Velcade in the U.S. with (just) 65 sales reps.”9” Velcade revenues more than doubled to $142 million in 2004, but flattened during the latter part of 2004 and beginning of 2005. Millennium’s ‘management was also concerned about Integrilin revenues, which grew by just 12%, to $206 million, in 2004. Management turnover One executive traced some of Millennium’s underperforming Velcade and Integrilin sales to commercial management turnover. Millennium hired Paul Hemelin to head Commercial Operations in December 2000 and he left shortly thereafter. In 2002, Millennium appointed Vaughn Kailian (the former CEO and president of COR) as Vice Chairperson of the Board of Directors and Head of Commercial Operations, although he resigned his commercial role in 2003. Millennium CFO Kenneth Bate moved over to run Millennium’s commercial operations in July 2003, Bate resigned in January 2005, and Levin covered the vacant position. ‘One executive reflected, “While there were several factors for the turnover in the commercial group, Millennium’s legacy and commitment to science was a key factor. Millennium’s management believed that markets were won through good science and clinical data so products based on good data would sell themselves. This philosophy left little room for a marketer to express his or her opinions on competing in the marketplace through education and promotion.” Challenge of commercializing two products In the interim, two commercial managers ‘who came over from the COR acquisition ran Millennium’s team of US. marketing representatives. Most of the representatives had backgrounds in the cardiovascular market but were responsible for marketing both Integrilin (cardiovascular) and Velcade (oncology). Millennium outsourced international marketing to partner firms Schering Plough and Johnson & Johnson, respectively. In contrast to Millennium’s stagnant domestic Velcade sales, Johnson & Johnson was producing robust overseas revenue growth. Kyle Kuvalanka, Vice President of Investor Relations, highlighted some of the challenges facing Millennium’s US. sales force: Millennium’s commercial team was relatively small. Leveraging our limited capacity and capabilities across the two products was a challenge. For example, the physician groups were ‘specialists in their respective areas and did not necessarily even work in the same locations. The Velcade sales team detailed to oncologists with a vast majority working from their own Private practices or in out-patient units of hospitals. The Integrilin team detailed to cardiologists and purchasing groups in hospitals with critical care facilities for percutaneous infusions. Both therapeutic areas required keen understanding of the clinical trial results of their respective products and those of their competitors. It was unrealistic to require a sales “This document is COngintation and Strategy at Millennium (A) rioats that representative to master the material of bolt ee Comptentog i ee hat ‘products faced intense competition requ wvestment both igre I was dict imagine dituting the focus of 8 ‘commercial rep by leveraging, him ot her to work on both products.” Discovery Research and Development ea ‘As Millennium continued moving away from pure discovery research Gal Paetuaresions activities, there was a high probability that Robert Tepper, MOD, Head of R&D Ae uD leadershi usiness focused on his specialty, early-stage research. So Dunsire faced a poten tt mae 7 snes tionally, since the current level of R&D expendltur’ at Millennium was so high, Dansire knew that she needed to quickly get her arms ‘around the firm's R&D operations a @etermine which projects to continue funding and which projects to cut. Given Dunsire’s limited MRT), one of her options to fill the Head of R&D role was to hire an experienced leader freon outside the firm, bringing in a new set of skills and ideas. ‘Dunsire could promote one of Millennium’s top R&D managers, each of whom she able of running the firm's R&D group. Joe Bolen, PhD. (SVP Research) consi lennium from Hoechst Marion's oncology group in 1999 and by 2905 was i te of joie Mum's early-stage research and drug discovery efforts. Nancy Simoni MD. (GVP Development) covered the laterstage activites of clinical testing, medical ‘benefit risk assessments, tind regulatory affairs; Simonian joined Millennium from Biogen’s clinical research team in 2001. are eevith, PhD. (VP Nonclinical Development Sciences) bridged the discovery efforts of Bolen’s group through lead compound sel ‘Simonian’s group by lection and the later-stage clinical work of Felping to launch clinical trials; Smith joined from Pharmacia in 1959. However, both of these options {extemal hire or internal promotion) introduced several complications. As one ‘executive observed, ‘Gilling Tepper’s role either through an internal promotion or external appointment risked disenfranchising at least two of Millennium’s top scientists."#° ‘Dunsire could also “flatten” the organization by eliminating the Head of R&D position and Fave the three SVPs of R&D report directly to her. This approach would allow Dunsire °° strengthen supervision over resource allocation in R&D and prevent such problems as those associated with Pinject 241, But flattening and increasing her span of control (Le. the number of tisect reports) would require a dee commitment on her part and risked distracting her from leadership responsibilities, particularly in the commercial and financial arenas, Investor Relations Millennium’s stock price peaked at $85.60 on November 7, 2000, giving the firm a market capitalization of $18 billion just before the technology bubble burst. Following the market crash, spin tried to appease investors by announcing that Millennium would turn profitable in 2004, Ip 2003, Levin withdrew his earlier financial guidance and projected that Millennium would ‘rt profitable in 2006; investors reacted unfavorably. By December 31, 2003, Millennium’s stock Price had Fallen by 78% to $18.65, reflecting challenges inthe capital markets, the biotechnology industry and ot Millennium. issued 2004 projected sales guidance for Integrilin in the range of on ane 2 Mile ei ts Mangan chee uae? Millennium’s, "2004 guidance was modestly disappointing.”*' In April, a SG Cowen equity research analyst noted, “Both Velcade and Integrlin falling short of our estimates.” In July, Millennium svithdrew its 2004 revenue guidance for Integrilin noting that sales would fall short of previow® company guidance. 10 unr fr us Pr Ina Me's POM GMP 2025-28 Term Corporta Sratgy and Statgy knlamertaion (C18S1025~) "Retains Intute (XLRI fo Aug 2025 10 Feb 2028. 223397 2 PZ 0} Seno somyd sola say Sands UorRnAUpY Sud pw Pood 'SA+ Suman Uy spunodino> Po =< (vorpise pur \orncesap “spear ‘uondinsp) AWWA pw Aros “ooyp ouaTO. 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TH 10% 10% Is em pdenseuttanding atyearetd me mr OMS HAE 7% feanend market price of Mitlenniua’s tock goss ssi $794 S1865_S124 | a Femme Ses = —— a | —— SSS ———— SSS ————— = — ——__ —— a | ————— SS _—__ —=====3 a | =—— = __ — | —— asa | = moan =—— od — 7 ———— ed aS Sereno ———— carervoess SS == Source: Company ‘management draft report titled, “Recap ofthe 2005/2006 Employee Survey and Pulse Survey - Results Ms tocmerta nerd or we only in Pro. tna cate 225-20 (em

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