生技醫藥業之創新授權合作與鑑價模式

Valuation Model and Innovative Partnershop for Bio-Pharma Alliances

袁照晶(Chao-Chin Yuan)

指導教授 ： 江炯聰

國立臺灣大學/管理學院/商學研究所/碩士(2005年)

https://doi.org/10.6342/NTU.2005.00239

摘要

論文摘要
授權合作、策略聯盟是生技公司生存與藥廠獲利最重要的價值創造活動。但是有如許多生技界領袖說的：生技合作過程好比藝術創作（The craft of Art）般複雜，而過程中最重要的鑑價更簡直有如黑盒子(Black Box)般難解。到底要如何思考授權合作？如何鑑定價值？如何選定合作模式與交易條件？這些策略聯盟最重要的問題，答案難尋。現存相關資料珍貴而難尋，不是動輒幾十萬台幣商情、就是資料專注在某一角度與僅一部分，根本難以提供生技公司一全盤瞭解與思考的機會。
不過，這些有如藝術創作的授權以及有如黑盒子般的鑑價，其實並非難以理解。本論文，旨在提供生技公司一個授權合作較為完整而具邏輯與實用價值的參考資訊。透過業界專家與國外文獻、商情資料等，本研究提供了生技公司在授權合作各層面之關鍵議題參考。從如何依公司成長目標選擇授權策略、考量風險、瞭解創新授權鑑價方式、到決定最適合的交易模式與條件等，都是本論文中討論的重要內容。相關摘要如下：
研發能力降低、競爭導致藥物商品化費用大增、日益緊縮的專利期間等等因素都大幅提高了開發新藥的成本。根據Tuff Center for the Sutdy of Drug Development 研究，開發新藥成本已經逼近九億美元，甚至更有業界預估，加上各種行銷費用，成功讓藥物上市的各項費用高達17億美元，以探索階段藥物標的起算，平均成功率為5% 。
2004年美國食品與藥物管理局總共只許可了37項新藥上市，其中有六件是生技藥物審查。開發藥物的困難度，加上法人投資市場(華爾街)對藥廠每年成長的預期，讓藥廠紛紛轉向生技公司展開各種授權合作以取得更多產品並降低藥物開發的成本、風險與時間。在1988年之後，約有兩萬件各種業界授權合作案，而且每年平均以25%速度增加 。從1998到1990年間，全球前二十大藥廠完成了186件授權案，到了2000年到2002年間，這個數字成長超過四倍，成為757件合作案。
具有潛力的藥物標的，加上國際級藥廠看起來也許成功相十足，但事實並非如此。依公司的目標訂定良好的策略方向，仔細查核授權機會、建立雙方都認同的鑑價模式，完成符合雙方利益的交易架構，才是授權合作案成功的最佳途徑。
本論文提供了藥廠與生技公司對外授權時的幾項重要考量：
1. 如何以公司成長目標選擇授權策略
2. 如何建立雙贏互惠的鑑價模式
3. 如何依鑑定價值建立一交易架構與條件
一樣是授權合作到底內容如何隨時代與產業變遷而不同呢？本論文將探討以下趨勢
1. 合作授權對象非僅限與大藥廠對生技公司。
2. 授權案價值大增，晚期與早期開發階段標的皆熱門。
3. 各種創新合作模式出現。
本論文將透過文獻回顧、以產業分析、個案研究瞭解架構成功授權合作的各關鍵環節，並以生技醫藥業熟悉之風險調整鑑價模式為基礎，提出一涵括藥品開發之有形與無形因素之鑑價模式。冀望提供一較為完整之授權交易過程，並於其中建立一符合實質運用價值之鑑價模式，以此提供予國內生技公司與藥廠參考。

關鍵字

生技 ； 醫藥 ； 授權 ； 鑑價 ； 策略聯盟

並列摘要

THESIS ABSTRACT
Innovative Partnership and Valuation Model
For Bio-pharmaceutical Licensing Deals

GRADUATE INSTITUTE OF BUSINESS ADMINISTRATION
NATIONAL TAIWAN UNIVERSITY

NAME：Chao Chin Yuan MONTH/YEAR：JUNE, 2005
ADVISER：Professor Dr. Jong-Tsong Chiang　
Getting new drugs to market continue to face the challenges of long time frames, daunting costs and immense risks. Of every 1,000 experimental drug compounds in any form of preclinical testing, only one actually makes it to clinical trials. After that, only one in five of those drugs finally makes it to market.
According to a 2003 report from the Tufts Center for the Study of Drug Development, the cost of developing a new drug and getting it to market averaged $897 million, up from about $802 million in 2001, while according to the consulting firm Bain & Co. the cost went up to $1.7 billion, including factors as marketing and advertising expenses.
As a result of these high risks, costs and the lengthy time-to-market, young biotech companies encounter a harsh financial challenge. Biotechnology firms continue to look to mature, global pharmaceutical companies for cash, marketing muscle, distribution channels and regulatory expertise. On the other hand, pharmaceutical firms both large and small are under constant pressure because blockbuster drugs that have made immense profits for many years are soon losing their patent protection and facing vast competition from generic drugs.
In addressing these issues, deal making between the pharmaceutical and biotechnological industries have emerged. The extent of deal making and alliances has grown continually from the earliest 1970s and accelerated with the advent of biotechnology and the need of pharmaceutical companies to enhance their development pipelines. Pharmaceutical companies now depend on alliances for 25% to 60% of their pipeline while biotechnology accounts 50% of their revenue from alliance deals.
While deal making serves the necessity for both biotechnology and pharmaceutical companies, it does not guarantee the success of such attempts. A high failure rate of drug development project initiated from alliance deal demonstrates the risk involved in deal making.
To negotiate optimal deals, both the biotech and pharmaceutical companies need to focus on two areas: fairly valuing the product by recognizing the contribution of each partner; structuring appropriate deal model and terms. Only deals reflect fair valuations and appropriate structured will serve as the foundation in bringing a lucrative and successful collaboration over the long term.
The study addresses the key aspects in deal making in terms of strategy, valuation, structure of licensing collaborations. This stuty also reviews current valuation models used in licensing deals and introduces an innovative valuation model which includes both tangible and intangible factors of valuation.
Chapter 2 provides an overview of the reasons why biotech and pharmaceuticals choose to partner and the process of deal making.
Chapter 3 takes an in-depth look at the various goals and strategies deployed by participants of licensing deals.
Chapter 4 covers a detail analysis in drug development process and industry value chain which serve as the foundation in licensing valuations.
Chapter 5 introduces the tangible aspects as the key indicator of licensing valuation.
Chapter 6 reviews the major valuation models and focuses on the risk adjusted Net Present Value model.
Chapter 7 proposed an innovation valuation model that inspects both the tangible and intangible aspects of licensing valuation—the Risk Adjusted and intangibles accessed Present Value Model.
Chapter 8 introduces the use of comparable deals as the market indicator of the licensing value.
Chapter 9 applies the r.i.NPV model to a drug candidate in real licensing deal as the target of valuation case study.
Chapter 10 examines different deal structure and payment strategies with a host of case studies that exemplifies each model.
Chapter 11 looks at the innovative co-development model of partnering evolved in maximizing value for a win-win partnership.
In conclusion, this study covers the aspects of licensing deal making and suggests a practical approach to innovative licensing partnerships and valuations. By establishing a systematic and transparent deal making process, this thesis believes that the two sides of the negotiation would be able to built a true partnership which promises the ultimate success—the blockbuster drug on the market.

並列關鍵字

Biotech ； pharmaceutical ； valuation ； alliance ； licensing

參考文獻

16. Ernest & Young Global Health Science, “Beyond Borders, The Global Biotechnology Report 2002”, June 2002

17. Ernest & Young., 2004生技產業年鑑, 2004, p.10-12

19. French, J. M., “Partnering challenges for startups”, Nature Biotechnology, 20, Supplement, pp. BE40-42, 2002

22. Gomes-Casseres, B., The alliance Revolution:The New Shape of Business Roivlry, 2003

27. Johnson & Johnson Press Release, Johnson & Johnson to Acquire Scios Inc. February 10, 2003