5. NOVARTIS RELATIONSHIP
Overview
In May 2003, we entered into a collaboration with Novartis relating to the worldwide
development and commercialization of our drug candidates. In May 2003, Novartis also purchased
approximately 54% of our common stock. Since this date, Novartis has had the ability to exercise
control over our strategic direction, research and development activities and other material
business decisions.
Pursuant to the development and commercialization agreement, as amended, we have granted
Novartis the option to license any of our development-stage drug candidates, so long as Novartis
maintains at least 30% ownership of our common stock. Novartis may exercise this option generally
after demonstration of activity and safety in a proof-of-concept clinical trial. If Novartis
licenses a drug candidate, it is obligated to fund a portion of the development expenses that we
incur in accordance with development plans agreed upon by us and Novartis. Under the development
and commercialization agreement, we have granted Novartis an exclusive worldwide license to market
and sell drug candidates that Novartis chooses to license from us. The commercialization rights
under the development and commercialization agreement also include our right to co-promote or
co-market all licensed products in the United States, United Kingdom, France, Germany, Italy and
Spain. Under the development and commercialization agreement, we granted Novartis an exclusive
worldwide license to market and sell telbivudine (Tyzeka®/Sebivo®),
valtorcitabine and valopicitabine.
In 2003, Novartis licensed telbivudine from us under the development and commercialization
agreement and we co-developed and co-launched Tyzeka®/Sebivo® for the
treatment of HBV. In September 2007, we amended the development and commercialization agreement and
we transferred to Novartis our worldwide development, commercialization and manufacturing rights
and obligations pertaining to telbivudine in exchange for royalties based on net product sales of
Tyzeka®/Sebivo® from Novartis. The royalty percentage increases according to
specified tiers of net sales and the percentage varies based on specified territories and the
aggregate dollar amounts of net sales. We recognized $1.2 million and $0.9 million as royalty
revenue from Novartis’ sales of Tyzeka®/Sebivo® during the three months ended
June 30, 2011 and 2010, respectively, and we recognized $2.2 million and $1.9 million as royalty
revenue from Novartis’ sales of Tyzeka®/Sebivo® during the six months ended
June 30, 2011 and 2010, respectively. The receivables from related party balances of $1.2 million
and $0.8 million at June 30, 2011 and December 31, 2010, respectively, consisted of royalties
associated with product sales of Tyzeka®/Sebivo® from Novartis.
In October 2009, Novartis waived its right to license IDX184. As a result, we retain the
worldwide rights to develop, commercialize and license IDX184. We may seek a partner that will
assist in the future development and commercialization of this drug candidate.
To date, we have received $117.2 million of non-refundable payments from Novartis under the
development and commercialization agreement that have been recorded as deferred revenue. The $117.2
million of deferred payments are being recognized over the development period of the licensed drug
candidates, which represents the period of our continuing obligations. We estimate this period to
be through May 2021 based on current judgments related to the product development timeline of our
licensed drug candidates. We review our assessment and judgment on a quarterly basis with respect
to the expected duration of the development period of our licensed drug candidates. If the
estimated performance period changes, we will adjust the periodic revenue that is being recognized
and will record the remaining unrecognized non-refundable payments over the remaining development
period during which our performance obligations will be completed. Significant judgments and
estimates are involved in determining the estimated development period and different assumptions
could yield materially different results. Related to the deferred revenue, we recognized $0.8
million and $1.3 million as revenue during the three months ended June 30, 2011 and 2010,
respectively, and we recognized $1.6 million and $2.8 million as revenue during the six months
ended June 30, 2011 and 2010, respectively. These amounts are impacted by Novartis’ stock
subscription rights described below.
As mentioned above, in addition to the collaboration, in May 2003, Novartis purchased
approximately 54% of our outstanding common stock from our then existing stockholders. The
stockholders received $255.0 million in cash from Novartis with an additional aggregate amount of
up to $357.0 million contingently payable to these stockholders if we achieve predetermined
development milestones relating to specific HCV drug candidates. As of July 22, 2011, Novartis
owned approximately 35% of our outstanding common stock.
Stockholders’ Agreement
In connection with Novartis’ purchase of stock from our stockholders, we, Novartis and
substantially all of our stockholders at that time entered into a stockholders’ agreement, which we
refer to as the stockholders’ agreement. The stockholders’ agreement was amended and restated in
2004 in connection with our initial public offering of our common stock and amended in April 2011
in connection with a subsequent offering of our common stock. The stockholders’ agreement, as
amended, provides, among other things, that we will use our reasonable best efforts to nominate for
election as a director at least two designees of Novartis for so long as Novartis and its
affiliates own at least 30% of our voting stock and that we will use our reasonable best efforts to
nominate for election as a director at least one designee of Novartis for so long as Novartis and
its affiliates own at least 19.4% of our voting stock. As long as Novartis and its affiliates
continue to own at least 19.4% of our voting stock, Novartis will have approval rights over a
number of corporate actions that we may take, including the authorization or issuance of additional
shares of capital stock and significant acquisitions and dispositions.
Novartis’ Stock Subscription Rights
Under our stock purchase agreement with Novartis, which we refer to as the stock purchase
agreement, Novartis has the right to
purchase, at par value of $0.001 per share, such number of shares as is required to maintain its
percentage ownership of our voting stock if we issue shares of capital stock in connection with the
acquisition or in-licensing of technology through the issuance of up to 5% of our stock in any
24-month period. These purchase rights of Novartis remain in effect until the earlier of: a) the
date that Novartis and its affiliates own less than 19.4% of our voting stock; or b) the date that
Novartis becomes obligated to make the additional contingent payments of $357.0 million to holders
of our stock who sold shares to Novartis on May 8, 2003.
In addition to the right to purchase shares of our stock at par value as described above, if
we issue any shares of our capital stock, other than in certain situations, Novartis has the right
to purchase such number of shares required to maintain its percentage ownership of our voting stock
for the same consideration per share paid by others acquiring our stock. Any financing requiring
the issuance of additional shares of capital stock must first be approved by Novartis so long as
Novartis continues to own at least 19.4% of our voting stock. In May 2009 and April 2011, we
received approval from Novartis to issue capital shares pursuant to a financing under an existing
shelf registration statement filed with the SEC in September 2008 so long as the issuance of shares
did not reduce Novartis’ interest in Idenix below specified levels, 40% and 30%, respectively.
Pursuant to this shelf registration statement, in August 2009 and in April 2010, we issued
approximately 7.3 million and approximately 6.5 million shares, respectively, of our common stock
pursuant to underwritten offerings and received $21.2 million and $26.3 million in net proceeds,
respectively. Novartis did not participate in either of these offerings. On April 13, 2011, we
issued approximately 21.1 million shares of our common stock pursuant to this shelf registration
statement and approximately 1.8 million shares of our common stock to Novartis pursuant to a
private placement agreement. The net proceeds of both transactions were $60.2 million. Upon
completion of this offering, we have fully utilized the shelf registration statement. As of July
22, 2011, Novartis owned approximately 35% of our outstanding common stock.
In connection with the closing of our initial public offering in July 2004, Novartis
terminated a common stock subscription right with respect to approximately 1.4 million shares of
common stock issuable by us as a result of the exercise of stock options granted after May 8, 2003
pursuant to the 1998 equity incentive plan. In exchange for Novartis’ termination of such right, we
issued 1.1 million shares of common stock to Novartis for a purchase price of $0.001 per share. The
fair value of these shares was determined to be $15.4 million at the time of issuance. As a result
of the issuance of these shares, Novartis’ rights to purchase additional shares as a result of
future option grants and stock issuances under the 1998 equity incentive plan were terminated and
no additional adjustments to revenue and deferred revenue will be required. Prior to the
termination of the stock subscription rights under the 1998 equity incentive plan, as we granted
options that were subject to this stock subscription right, the fair value of our common stock that
would be issuable to Novartis, less par value, was recorded as an adjustment of the non-refundable
payments received from Novartis. We remain subject to potential revenue adjustments with respect to
grants of options and stock awards under our stock incentive plans other than the 1998 equity
incentive plan.
Upon the grant of options and stock awards under our stock incentive plans, with the exception
of the 1998 equity incentive plan, the fair value of our common stock that would be issuable to
Novartis, less the exercise price, if any is payable by the option or award holder, is recorded as
a reduction of the non-refundable payments associated with the Novartis collaboration. The amount
is attributed proportionately between cumulative revenue recognized through the current date and
the remaining amount of deferred revenue. These amounts will be adjusted through the date that
Novartis elects to purchase the shares to maintain its percentage ownership based upon changes in
the value of our common stock and in Novartis’ percentage ownership.
As of June 30, 2011, the aggregate impact of Novartis’ stock subscription rights has reduced
the non-refundable payments by $18.3 million, which has been recorded as additional paid-in
capital. Of this amount, $4.7 million has been recorded as a reduction of deferred revenue with the
remaining amount of $13.6 million recorded as a reduction of license fee revenue. For the three
months ended June 30, 2011, the impact of Novartis’ stock subscription rights has increased
additional paid-in capital by $2.2 million, decreased deferred revenue by $0.7 million and
decreased license fee revenue by $1.5 million. For the six months ended June 30, 2011, there was no
cumulative significant impact of Novartis’ stock subscription rights to additional paid-in capital,
deferred revenue or license fee revenue as the value of Novartis’ stock subscription rights at June
30, 2011 was comparable with the value at December 31, 2010.
Manufacturing and Supply Agreement
Under the master manufacturing and supply agreement, dated May 8, 2003, with Novartis, which
we refer to as the manufacturing and supply agreement, we appointed Novartis to manufacture or have
manufactured the clinical supply of the active pharmaceutical ingredient, or API, for each drug
candidate licensed under the development and commercialization agreement and certain other drug
candidates. The cost of the clinical supply will be treated as a development expense, allocated
between us and Novartis in accordance with the agreement. We have the ability to appoint Novartis
or a third-party to manufacture the commercial supply of the API based on a competitive bid process
in which Novartis has the right to match the best third-party bid. Novartis will perform the
finishing and packaging of the API into the final form for sale.
Product Sales Arrangement
In connection with the drug candidates that Novartis licenses from us, with the exception of
Tyzeka®/Sebivo®, we have retained the right to co-promote or co-market all
licensed products in the United States, United Kingdom, France, Germany, Italy and Spain. In the
United States, we would act as the lead commercial party and record revenue from product sales and
share equally the net benefit from co-promotion from the date of product launch. In the United
Kingdom, France, Germany, Italy and Spain, Novartis would act as the lead commercial party, record
revenue from product sales and would share with us the net benefit from co-promotion and
co-marketing. The net benefit is defined as net product sales minus related cost of sales. The
amount of the net benefit that would be shared with us would start at 15% for the first 12-month
period following the date of launch, increasing to 30% for the second 12-month period following the
date of launch and 50% thereafter. In other countries, we would effectively sell products to
Novartis for their further sale to third-parties. Novartis would pay us for such products at a
price that is determined under the terms of our manufacturing and supply agreement with Novartis
and we would receive a royalty payment from Novartis on net product sales.