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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Form 10-Q
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☑ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2024
OR
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☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from _____________to___________
Commission file number 001-39695
VIATRIS INC.
(Exact name of registrant as specified in its charter)
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Delaware | | 83-4364296 |
(State or other jurisdiction of incorporation or organization) | | (I.R.S. Employer Identification No.) |
1000 Mylan Boulevard, Canonsburg, Pennsylvania 15317
(Address of principal executive offices)
(724) 514-1800
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
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Title of Each Class: | | Trading Symbol(s) | | Name of Each Exchange on Which Registered: |
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Common Stock, par value $0.01 per share | | VTRS | | The NASDAQ Stock Market |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☑ No ☐
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer | | ☑ | | Accelerated filer | | ☐ |
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Non-accelerated filer | | ☐ | | Smaller reporting company | | ☐ |
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| | | | Emerging growth company | | ☐ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date.
The number of shares of common stock outstanding, par value $0.01 per share, of the registrant as of August 5, 2024 was 1,193,520,463.
VIATRIS INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q
For the Quarterly Period Ended
June 30, 2024
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| PART I — FINANCIAL INFORMATION | |
ITEM 1. | Condensed Consolidated Financial Statements (unaudited) | |
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ITEM 2. | | |
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ITEM 3. | | |
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ITEM 4. | | |
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| PART II — OTHER INFORMATION | |
ITEM 1. | | |
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ITEM 1A. | | |
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ITEM 2. | | |
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ITEM 5. | | |
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ITEM 6. | | |
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Glossary of Defined Terms
Unless the context requires otherwise, references to “Viatris,” “the Company,” “we,” “us” or “our” in this Form 10-Q (defined below) refer to Viatris Inc. and its subsidiaries. We also have used several other terms in this Form 10-Q, most of which are explained or defined below. Some amounts in this Form 10-Q may not add due to rounding.
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2003 LTIP | Mylan N.V. Amended and Restated 2003 Long-Term Incentive Plan |
2020 Incentive Plan | Viatris Inc. 2020 Stock Incentive Plan |
2023 Form 10-K | Viatris’ annual report on Form 10-K for the fiscal year ended December 31, 2023, as amended |
Adjusted EBITDA | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - EBITDA (defined below) is further adjusted for share-based compensation expense, litigation settlements, and other contingencies, net, restructuring and other special items |
ANDA | Abbreviated New Drug Application |
Announced Divestitures | All of the following transactions: on October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business and had entered into definitive agreements to divest its women’s healthcare business and, separately, in another transaction, its rights to two women’s healthcare products in certain countries, its API business in India and commercialization rights in the Upjohn Distributor Markets |
AOCE | Accumulated other comprehensive earnings |
API | Active pharmaceutical ingredients |
ARV | Antiretroviral medicines |
ASC | Accounting Standards Codification |
ASU | Accounting Standards Update |
Biocon | Biocon Limited |
Biocon Biologics | Biocon Biologics Limited, a majority owned subsidiary of Biocon |
Biocon Biologics Transaction | The transaction between Viatris and Biocon Biologics pursuant to which Viatris contributed its biosimilars portfolio, composed of the Biocon collaboration programs, biosimilars to Humira®, Enbrel®, and Eylea®, as well as related assets and liabilities to Biocon Biologics |
Biocon Agreement | The transaction agreement between Viatris and Biocon Biologics, dated February 27, 2022, relating to the Biocon Biologics Transaction, as amended from time to time |
Business Combination Agreement | Business Combination Agreement, dated as of July 29, 2019, as amended from time to time, among Viatris, Mylan, Pfizer and certain of their affiliates |
CAMT | U.S. corporate alternative minimum tax |
CCPS | Compulsory convertible preferred shares |
Code | The U.S. Internal Revenue Code of 1986, as amended |
Combination | Refers to Mylan combining with Pfizer's Upjohn Business in a Reverse Morris Trust transaction to form Viatris on November 16, 2020 |
Commercial Paper Program | The $1.65 billion unsecured commercial paper program entered into as of November 16, 2020 by Viatris, as issuer, Mylan Inc., Utah Acquisition Sub Inc. and Mylan II B.V., as guarantors, and certain dealers from time to time |
CP Notes | Unsecured, short-term commercial paper notes issued pursuant to the Commercial Paper Program |
Developed Markets segment | Viatris’ business segment that includes our operations primarily in the following markets: North America and Europe |
Distribution | Pfizer's distribution to Pfizer stockholders all the issued and outstanding shares of Upjohn Inc. |
DOJ | U.S. Department of Justice |
EBITDA | Non-GAAP financial measure that the Company believes is appropriate to provide information to investors - U.S. GAAP net earnings (loss) adjusted for income tax provision (benefit), interest expense and depreciation and amortization |
EDPA | U.S. District Court for the Eastern District of Pennsylvania |
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Emerging Markets segment | Viatris’ business segment that includes, but is not limited to, our operations primarily in the following markets: Parts of Asia, the Middle East, South and Central America, Africa, and Eastern Europe |
EPS | Earnings per share |
EU | European Union |
Exchange Act | Securities Exchange Act of 1934, as amended |
Famy Life Sciences | Famy Life Sciences Private Limited |
FASB | Financial Accounting Standards Board |
FDA | U.S. Food and Drug Administration |
Form 10-Q | This quarterly report on Form 10-Q for the quarterly period ended June 30, 2024 |
GA Depot | Long-acting glatiramer acetate depot product |
Global Systemically Important Banks | Financial institutions that are considered systemically important by the Financial Stability Board |
Greater China segment | Viatris’ business segment that includes our operations primarily in the following markets: China, Taiwan and Hong Kong |
Gx | Generic drugs |
Idorsia | Idorsia Pharmaceuticals Ltd. |
Idorsia Transaction | The transaction between Viatris and Idorsia pursuant to which Viatris acquired the development programs and certain personnel related to selatogrel and cenerimod from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential development and regulatory milestone payments, certain contingent payments of tiered sales milestones, as well as potential contingent tiered sales royalties |
IPR&D | In-process research and development |
IRS | U.S. Internal Revenue Service |
IT | Information technology |
JANZ segment | Viatris’ business segment that includes our operations in the following markets: Japan, Australia and New Zealand |
Mapi | Mapi Pharma Ltd. |
Maximum Leverage Ratio | The maximum consolidated leverage ratio financial covenant requiring maintenance of a maximum ratio of consolidated total indebtedness as of the end of any quarter to consolidated EBITDA for the trailing four quarters as defined in the related credit agreements from time to time |
MDL | Multidistrict litigation |
Mylan | Mylan N.V. and its subsidiaries |
Mylan Inc. U.S. Dollar Notes | The 4.550% Senior Notes due 2028, 5.400% Senior Notes due 2043 and 5.200% Senior Notes due 2048 issued by Mylan Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan II B.V., Viatris Inc. and Utah Acquisition Sub Inc. |
| |
NASDAQ | The NASDAQ Stock Market |
NDA | New drug application |
Note Securitization Facility | The note securitization facility entered into in August 2023 for borrowings up to $200 million and expiring in August 2024 |
OTC | Over-the-counter |
OTC Business | Viatris’ OTC business that the Company divested to Cooper Consumer Health SAS in July 2024, including two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy. This excludes the Company’s rights for Viagra®, Dymista® (which, in certain limited markets, are sold as OTC products), and select OTC products in certain markets. |
OTC Transaction | On October 1, 2023, Viatris announced it had received an offer for the divestiture of its OTC Business. In January 2024, we exercised our option to accept the offer and entered into a definitive transaction agreement with respect to such OTC Transaction. The OTC Transaction closed in July 2024. |
Oyster Point | Oyster Point Pharma, Inc. |
Pfizer | Pfizer Inc. |
PSUs | Performance awards |
| | | | | |
R&D | Research and development |
Receivables Facility | The $400 million accounts receivable facility entered into in August 2020 and expiring in April 2025 |
Registered Upjohn Notes | The 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on October 29, 2021 registered with the SEC in exchange for the corresponding Unregistered Upjohn U.S. Dollar Notes in a similar aggregate principal amount and with terms substantially identical to the corresponding Unregistered Upjohn U.S. Dollar Notes and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
Respiratory Delivery Platform | Pfizer’s proprietary dry powder inhaler delivery platform |
Restricted Stock Awards | The Company’s nonvested restricted stock and restricted stock unit awards, including PSUs |
Revolving Facility | The $4.0 billion revolving facility dated as of July 1, 2021, by and among Viatris, certain lenders and issuing banks from time to time party thereto and Bank of America, N.A., as administrative agent |
RICO | Racketeer Influenced and Corrupt Organizations Act |
SARs | Stock appreciation rights |
SDNY | U.S. District Court for the Southern District of New York |
SEC | U.S. Securities and Exchange Commission |
Securities Act | Securities Act of 1933, as amended |
Senior U.S. Dollar Notes | The Upjohn U.S. Dollar Notes, the Utah U.S. Dollar Notes and the Mylan Inc. U.S. Dollar Notes, collectively |
Separation and Distribution Agreement | Separation and Distribution Agreement between Viatris and Pfizer, dated as of July 29, 2019, as amended from time to time |
SG&A | Selling, general and administrative expenses |
stock awards | Stock options and SARs |
Teva | Teva Pharmaceutical Industries Ltd. |
TSA | Transition services agreements, including related distribution services |
U.K. | United Kingdom |
U.S. | United States |
U.S. GAAP | Accounting principles generally accepted in the U.S. |
Unregistered Upjohn U.S. Dollar Notes | The 1.650% Senior Notes due 2025, 2.300% Senior Notes due 2027, 2.700% Senior Notes due 2030, 3.850% Senior Notes due 2040 and 4.000% Senior Notes due 2050 originally issued on June 22, 2020 by Upjohn Inc. (now Viatris Inc.) in a private offering exempt from the registration requirements of the Securities Act and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
Upjohn | Upjohn Inc., a wholly owned subsidiary of Pfizer prior to the Distribution, that combined with Mylan and was renamed Viatris Inc. |
Upjohn Business | Pfizer’s off-patent branded and generic established medicines business that, in connection with the Combination, was separated from Pfizer and combined with Mylan to form Viatris |
Upjohn Distributor Markets | Select geographic markets that were part of the Combination that are smaller in nature and in which we had no established infrastructure prior to or following the Combination and that the Company has divested or intends to divest |
Upjohn U.S. Dollar Notes | Senior unsecured notes denominated in U.S. dollars and originally issued by Upjohn Inc. or Viatris Inc. pursuant to an indenture dated June 22, 2020 and fully and unconditionally guaranteed by Mylan Inc., Mylan II B.V. and Utah Acquisition Sub Inc. |
Utah Acquisition Sub | Utah Acquisition Sub Inc., a Delaware corporation and an indirect wholly owned subsidiary of Viatris |
Utah U.S. Dollar Notes | The 3.950% Senior Notes due 2026 and 5.250% Senior Notes due 2046 issued by Utah Acquisition Sub Inc., which are fully and unconditionally guaranteed on a senior unsecured basis by Mylan Inc., Viatris Inc. and Mylan II B.V. |
| | | | | |
Viatris | Viatris Inc., formerly known as Upjohn Inc. prior to the completion of the Combination |
YEN Term Loan Facility | The ¥40 billion term loan agreement dated as of July 1, 2021, among Viatris, the guarantors from time to time party thereto, the lenders from time to time party thereto and Mizuho Bank, Ltd., as administrative agent |
PART I — FINANCIAL INFORMATION
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited; in millions, except per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, | | June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Revenues: | | | | | | | |
Net sales | $ | 3,785.9 | | | $ | 3,909.5 | | | $ | 7,439.4 | | | $ | 7,628.6 | |
Other revenues | 10.7 | | | 9.1 | | | 20.6 | | | 19.1 | |
Total revenues | 3,796.6 | | | 3,918.6 | | | 7,460.0 | | | 7,647.7 | |
Cost of sales | 2,351.2 | | | 2,310.0 | | | 4,510.6 | | | 4,496.9 | |
Gross profit | 1,445.4 | | | 1,608.6 | | | 2,949.4 | | | 3,150.8 | |
Operating expenses: | | | | | | | |
Research and development | 204.1 | | | 208.3 | | | 403.8 | | | 391.2 | |
Acquired IPR&D | (7.8) | | | 10.2 | | | (1.7) | | | 10.2 | |
Selling, general and administrative | 1,358.0 | | | 1,031.9 | | | 2,375.5 | | | 1,990.8 | |
Litigation settlements and other contingencies, net | 131.0 | | | (11.0) | | | 207.8 | | | (10.4) | |
Total operating expenses | 1,685.3 | | | 1,239.4 | | | 2,985.4 | | | 2,381.8 | |
(Loss) earnings from operations | (239.9) | | | 369.2 | | | (36.0) | | | 769.0 | |
Interest expense | 145.8 | | | 143.7 | | | 284.2 | | | 290.7 | |
Other expense (income), net | 6.1 | | | (107.5) | | | (133.0) | | | (177.4) | |
(Loss) earnings before income taxes | (391.8) | | | 333.0 | | | (187.2) | | | 655.7 | |
Income tax (benefit) provision | (65.4) | | | 69.0 | | | 25.3 | | | 167.0 | |
Net (loss) earnings | $ | (326.4) | | | $ | 264.0 | | | $ | (212.5) | | | $ | 488.7 | |
(Loss) earnings per share attributable to Viatris Inc. shareholders | | | | | | | |
Basic | $ | (0.27) | | | $ | 0.22 | | | $ | (0.18) | | | $ | 0.41 | |
Diluted | $ | (0.27) | | | $ | 0.22 | | | $ | (0.18) | | | $ | 0.41 | |
Weighted average shares outstanding: | | | | | | | |
Basic | 1,191.1 | | | 1,199.0 | | | 1,193.1 | | | 1,200.8 | |
Diluted | 1,191.1 | | | 1,203.5 | | | 1,193.1 | | | 1,204.6 | |
See Notes to Condensed Consolidated Financial Statements
7
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive (Loss) Earnings
(Unaudited; in millions)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, | | June 30, |
| 2024 | | 2023 | | 2024 | | 2023 |
Net (loss) earnings | $ | (326.4) | | | $ | 264.0 | | | $ | (212.5) | | | $ | 488.7 | |
Other comprehensive loss, before tax: | | | | | | | |
Foreign currency translation adjustment | (89.7) | | | (254.1) | | | (432.2) | | | (208.8) | |
Change in unrecognized loss and prior service cost related to defined benefit plans | (5.6) | | | (6.8) | | | (11.8) | | | (5.5) | |
Net unrecognized gain on derivatives in cash flow hedging relationships | 8.7 | | | 36.8 | | | 37.4 | | | 39.6 | |
Net unrecognized gain (loss) on derivatives in net investment hedging relationships | 68.4 | | | (12.8) | | | 237.5 | | | (79.0) | |
Net unrealized gain (loss) on available-for-sale fixed income securities | — | | | 0.2 | | | (0.3) | | | 1.1 | |
Other comprehensive loss, before tax | (18.2) | | | (236.7) | | | (169.4) | | | (252.6) | |
Income tax provision (benefit) | 16.0 | | | 4.3 | | | 58.4 | | | (8.2) | |
Other comprehensive loss, net of tax | (34.2) | | | (241.0) | | | (227.8) | | | (244.4) | |
Comprehensive (loss) earnings | $ | (360.6) | | | $ | 23.0 | | | $ | (440.3) | | | $ | 244.3 | |
See Notes to Condensed Consolidated Financial Statements
8
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited in millions, except share and per share amounts)
| | | | | | | | | | | |
| June 30, 2024 | | December 31, 2023 |
ASSETS |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 917.2 | | | $ | 991.9 | |
Accounts receivable, net | 3,566.9 | | | 3,700.4 | |
Inventories | 3,942.1 | | | 3,469.7 | |
Prepaid expenses and other current assets | 1,757.0 | | | 2,028.1 | |
Assets held for sale | 1,608.9 | | | 2,786.0 | |
Total current assets | 11,792.1 | | | 12,976.1 | |
Property, plant and equipment, net | 2,662.6 | | | 2,759.6 | |
Intangible assets, net | 18,419.0 | | | 19,181.1 | |
Goodwill | 9,325.9 | | | 9,867.1 | |
Deferred income tax benefit | 685.3 | | | 692.9 | |
Other assets | 2,445.1 | | | 2,208.7 | |
Total assets | $ | 45,330.0 | | | $ | 47,685.5 | |
| | | |
LIABILITIES AND EQUITY |
Liabilities | | | |
Current liabilities: | | | |
Accounts payable | $ | 1,957.5 | | | $ | 1,938.2 | |
| | | |
Income taxes payable | 117.7 | | | 226.8 | |
Current portion of long-term debt and other long-term obligations | 2,367.4 | | | 1,943.4 | |
Liabilities held for sale | 32.8 | | | 275.1 | |
Other current liabilities | 3,233.8 | | | 3,393.9 | |
Total current liabilities | 7,709.2 | | | 7,777.4 | |
Long-term debt | 14,731.2 | | | 16,188.1 | |
Deferred income tax liability | 1,573.8 | | | 1,735.7 | |
Other long-term obligations | 1,795.8 | | | 1,516.9 | |
Total liabilities | 25,810.0 | | | 27,218.1 | |
Equity | | | |
Viatris Inc. shareholders’ equity | | | |
Common stock: $0.01 par value, 3,000,000,000 shares authorized; shares issued: 1,233,752,840 and 1,221,994,491 as of June 30, 2024 and December 31, 2023 | 12.3 | | | 12.2 | |
Additional paid-in capital | 18,853.3 | | | 18,814.7 | |
Retained earnings | 4,133.9 | | | 4,639.7 | |
Accumulated other comprehensive loss | (2,975.2) | | | (2,747.4) | |
| 20,024.3 | | | 20,719.2 | |
| | | |
Less: Treasury stock — at cost | | | |
Common stock shares: 40,483,663 and 21,239,521 as of June 30, 2024 and December 31, 2023 | 504.3 | | | 251.8 | |
Total equity | 19,520.0 | | | 20,467.4 | |
| | | |
Total liabilities and equity | $ | 45,330.0 | | | $ | 47,685.5 | |
See Notes to Condensed Consolidated Financial Statements
9
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Equity
(Unaudited; in millions, except share and per share amounts)
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Common Stock | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at March 31, 2024 | 1,230,891,074 | | | $ | 12.3 | | | $ | 18,839.8 | | | $ | 4,607.5 | | | 40,483,663 | | | $ | (504.3) | | | $ | (2,941.0) | | | | | $ | 20,014.3 | |
Net loss | — | | | — | | | — | | | (326.4) | | | — | | | — | | | — | | | | | (326.4) | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (34.2) | | | | | (34.2) | |
Issuance of restricted stock and stock options exercised, net | 2,801,327 | | | — | | | 0.5 | | | — | | | — | | | — | | | — | | | | | 0.5 | |
Taxes related to the net share settlement of equity awards | — | | | — | | | (22.4) | | | — | | | — | | | — | | | — | | | | | (22.4) | |
Share-based compensation expense | — | | | — | | | 34.7 | | | — | | | — | | | — | | | — | | | | | 34.7 | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Issuance of common stock | 60,439 | | | — | | | 0.7 | | | — | | | — | | | — | | | — | | | | | 0.7 | |
Cash dividends declared, $0.12 per common share | — | | | — | | | — | | | (147.2) | | | — | | | — | | | — | | | | | (147.2) | |
| | | | | | | | | | | | | | | | | |
Balance at June 30, 2024 | 1,233,752,840 | | | $ | 12.3 | | | $ | 18,853.3 | | | $ | 4,133.9 | | | 40,483,663 | | | $ | (504.3) | | | $ | (2,975.2) | | | | | $ | 19,520.0 | |
| | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Common Stock | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at December 31, 2023 | 1,221,994,491 | | | $ | 12.2 | | | $ | 18,814.7 | | | $ | 4,639.7 | | | 21,239,521 | | | $ | (251.8) | | | $ | (2,747.4) | | | | | $ | 20,467.4 | |
Net loss | — | | | — | | | — | | | (212.5) | | | — | | | — | | | — | | | | | (212.5) | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (227.8) | | | | | (227.8) | |
Issuance of restricted stock and stock options exercised, net | 11,643,434 | | | 0.1 | | | 7.1 | | | — | | | — | | | — | | | — | | | | | 7.2 | |
Taxes related to the net share settlement of equity awards | — | | | — | | | (51.2) | | | — | | | — | | | — | | | — | | | | | (51.2) | |
Share-based compensation expense | — | | | — | | | 81.4 | | | — | | | — | | | — | | | — | | | | | 81.4 | |
| | | | | | | | | | | | | | | | | |
Common stock repurchase | — | | | — | | | — | | | — | | | 19,244,142 | | | (252.5) | | | — | | | | | (252.5) | |
| | | | | | | | | | | | | | | | | |
Issuance of common stock | 114,915 | | | — | | | 1.3 | | | — | | | — | | | — | | | — | | | | | 1.3 | |
Cash dividends declared, $0.24 per common share | — | | | — | | | — | | | (293.3) | | | — | | | — | | | — | | | | | (293.3) | |
| | | | | | | | | | | | | | | | | |
Balance at June 30, 2024 | 1,233,752,840 | | | $ | 12.3 | | | $ | 18,853.3 | | | $ | 4,133.9 | | | 40,483,663 | | | $ | (504.3) | | | $ | (2,975.2) | | | | | $ | 19,520.0 | |
See Notes to Condensed Consolidated Financial Statements
10
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Common Stock | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at March 31, 2023 | 1,220,224,204 | | | $ | 12.2 | | | $ | 18,679.6 | | | $ | 5,252.5 | | | 21,239,521 | | | $ | (251.8) | | | $ | (2,764.6) | | | | | $ | 20,927.9 | |
Net earnings | — | | | — | | | — | | | 264.0 | | | — | | | — | | | — | | | | | 264.0 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (241.0) | | | | | (241.0) | |
Issuance of restricted stock and stock options exercised, net | 71,988 | | | — | | | 0.1 | | | — | | | — | | | — | | | — | | | | | 0.1 | |
Taxes related to the net share settlement of equity awards | — | | | — | | | (0.3) | | | — | | | — | | | — | | | — | | | | | (0.3) | |
Share-based compensation expense | — | | | — | | | 39.2 | | | — | | | — | | | — | | | — | | | | | 39.2 | |
| | | | | | | | | | | | | | | | | |
Issuance of common stock | 89,374 | | | — | | | 0.8 | | | — | | | — | | | — | | | — | | | | | 0.8 | |
Cash dividends declared, $0.12 per common share | — | | | — | | | — | | | (147.4) | | | — | | | — | | | — | | | | | (147.4) | |
| | | | | | | | | | | | | | | | | |
Balance at June 30, 2023 | 1,220,385,566 | | | $ | 12.2 | | | $ | 18,719.4 | | | $ | 5,369.1 | | | 21,239,521 | | | $ | (251.8) | | | $ | (3,005.6) | | | | | $ | 20,843.3 | |
| | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Common Stock | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at December 31, 2022 | 1,213,793,231 | | | $ | 12.1 | | | $ | 18,645.8 | | | $ | 5,175.6 | | | — | | | $ | — | | | $ | (2,761.2) | | | | | $ | 21,072.3 | |
Net earnings | — | | | — | | | — | | | 488.7 | | | — | | | — | | | — | | | | | 488.7 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (244.4) | | | | | (244.4) | |
Issuance of restricted stock and stock options exercised, net | 6,422,573 | | | 0.1 | | | 3.7 | | | — | | | — | | | — | | | — | | | | | 3.8 | |
Taxes related to the net share settlement of equity awards | — | | | — | | | (19.7) | | | — | | | — | | | — | | | — | | | | | (19.7) | |
Share-based compensation expense | — | | | — | | | 81.8 | | | — | | | — | | | — | | | — | | | | | 81.8 | |
Common stock repurchase | — | | | — | | | — | | | — | | | 21,239,521 | | | (251.8) | | | — | | | | | (251.8) | |
Issuance of common stock | 169,762 | | | — | | | 1.7 | | | — | | | — | | | — | | | — | | | | | 1.7 | |
Cash dividends declared, $0.24 per common share | — | | | — | | | — | | | (295.2) | | | — | | | — | | | — | | | | | (295.2) | |
Other | — | | | — | | | 6.1 | | | — | | | — | | | — | | | — | | | | | 6.1 | |
Balance at June 30, 2023 | 1,220,385,566 | | | $ | 12.2 | | | $ | 18,719.4 | | | $ | 5,369.1 | | | 21,239,521 | | | $ | (251.8) | | | $ | (3,005.6) | | | | | $ | 20,843.3 | |
See Notes to Condensed Consolidated Financial Statements
11
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited; in millions)
| | | | | | | | | | | |
| Six Months Ended |
| June 30, |
| 2024 | | 2023 |
Cash flows from operating activities: | | | |
Net (loss) earnings | $ | (212.5) | | | $ | 488.7 | |
Adjustments to reconcile net (loss) earnings to net cash provided by operating activities: | | | |
Depreciation and amortization | 1,477.3 | | | 1,416.7 | |
Share-based compensation expense | 81.4 | | | 81.8 | |
Deferred income tax benefit | (206.3) | | | (94.9) | |
| | | |
Loss on disposal of business | 188.4 | | | — | |
Acquired IPR&D | (12.7) | | | 10.2 | |
Other non-cash items | 76.1 | | | 42.9 | |
Litigation settlements and other contingencies, net | 214.0 | | | (6.3) | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | 32.6 | | | 69.2 | |
Inventories | (558.8) | | | (266.5) | |
Accounts payable | 56.3 | | | 192.7 | |
Income taxes | 18.7 | | | (22.1) | |
Other operating assets and liabilities, net | (160.8) | | | (416.1) | |
Net cash provided by operating activities | 993.7 | | | 1,496.3 | |
Cash flows from investing activities: | | | |
Cash paid for acquisitions, net of cash acquired | (350.0) | | | (667.7) | |
Capital expenditures | (108.6) | | | (115.6) | |
Purchase of marketable securities | (13.3) | | | (16.6) | |
Proceeds from the sale of marketable securities | 13.3 | | | 16.6 | |
Payments for product rights and other, net | (11.7) | | | (55.9) | |
Refunds (purchases) of IPR&D | 12.7 | | | (10.2) | |
Proceeds from sale of assets and subsidiaries | 677.7 | | | — | |
Proceeds from the sale of property, plant and equipment | 1.4 | | | 13.1 | |
Net cash provided by (used in) investing activities | 221.5 | | | (836.3) | |
Cash flows from financing activities: | | | |
| | | |
Payments of long-term debt | (801.7) | | | (750.1) | |
Purchase of common stock | (250.0) | | | (250.0) | |
Change in short-term borrowings, net | — | | | 23.1 | |
Taxes paid related to net share settlement of equity awards | (32.1) | | | (30.0) | |
Contingent consideration payments | (31.5) | | | (8.4) | |
| | | |
Cash dividends paid | (288.3) | | | (287.7) | |
Non-contingent payments for product rights | — | | | (9.7) | |
Issuance of common stock | 1.3 | | | 1.7 | |
Other items, net | 128.8 | | | 32.9 | |
Net cash used in financing activities | (1,273.5) | | | (1,278.2) | |
Effect on cash of changes in exchange rates | (16.8) | | | (12.9) | |
Net decrease in cash, cash equivalents and restricted cash | (75.1) | | | (631.1) | |
Cash, cash equivalents and restricted cash — beginning of period | 993.6 | | | 1,262.5 | |
Cash, cash equivalents and restricted cash — end of period | $ | 918.5 | | | $ | 631.4 | |
See Notes to Condensed Consolidated Financial Statements
12
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited)
1.General
The accompanying unaudited condensed consolidated financial statements (“interim financial statements”) of Viatris Inc. and subsidiaries were prepared in accordance with U.S. GAAP and the rules and regulations of the SEC for reporting on Form 10-Q; therefore, as permitted under these rules, certain footnotes and other financial information included in audited financial statements were condensed or omitted. The interim financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the interim results of operations, comprehensive loss, financial position, equity and cash flows for the periods presented.
These interim financial statements should be read in conjunction with the consolidated financial statements and notes thereto in Viatris’ 2023 Form 10-K. The December 31, 2023 condensed consolidated balance sheet was derived from audited financial statements.
The interim results of operations and comprehensive loss for the three and six months ended June 30, 2024, and cash flows for the six months ended June 30, 2024, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.
Beginning in 2024, upfront and milestone payments related to externally developed IPR&D projects acquired directly in a transaction other than a business combination, which were previously included in cash flows from operating activities in the condensed consolidated statements of cash flows, are now classified as cash flows from investing activities. Certain reclassifications were made to conform the prior period condensed consolidated financial statements to the current period presentation. The adjustments resulted in an increase to net cash provided by operating activities and an increase to net cash used in investing activities of $10.2 million for the six months ended June 30, 2023.
2.Revenue Recognition and Accounts Receivable
The Company recognizes revenues in accordance with ASC 606, Revenue from Contracts with Customers. Under ASC 606, the Company recognizes net revenue for product sales when control of the promised goods or services is transferred to our customers in an amount that reflects the consideration we expect to be entitled to in exchange for those goods or services. Revenues are recorded net of provisions for variable consideration, including discounts, rebates, governmental rebate programs, price adjustments, returns, chargebacks, promotional programs and other sales allowances. Accruals for these provisions are presented in the condensed consolidated financial statements as reductions in determining net sales and as a contra asset in accounts receivable, net (if settled via credit) and other current liabilities (if paid in cash).
Our net sales may be impacted by wholesaler and distributor inventory levels of our products, which can fluctuate throughout the year due to the seasonality of certain products, pricing, the timing of product demand, purchasing decisions and other factors. Such fluctuations may impact the comparability of our net sales between periods.
Consideration received from licenses of intellectual property is recorded as other revenues. Royalty or profit share amounts, which are based on sales of licensed products or technology, are recorded when the customer’s subsequent sales or usages occur. Such consideration is included in other revenues in the condensed consolidated statements of operations.
The following table presents the Company’s net sales by product category for each of our reportable segments for the three and six months ended June 30, 2024 and 2023, respectively:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Three Months Ended June 30, 2024 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 1,233.8 | | | $ | 535.7 | | | $ | 198.4 | | | $ | 395.2 | | | $ | 2,363.1 | |
| | | | | | | | | |
Generics | 1,085.4 | | | 3.3 | | | 151.2 | | | 182.9 | | | 1,422.8 | |
Total Viatris | $ | 2,319.2 | | | $ | 539.0 | | | $ | 349.6 | | | $ | 578.1 | | | $ | 3,785.9 | |
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Six Months Ended June 30, 2024 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 2,412.6 | | | $ | 1,077.5 | | | $ | 382.5 | | | $ | 799.6 | | | $ | 4,672.2 | |
| | | | | | | | | |
Generics | 2,072.0 | | | 5.4 | | | 284.9 | | | 404.9 | | | 2,767.2 | |
Total Viatris | $ | 4,484.6 | | | $ | 1,082.9 | | | $ | 667.4 | | | $ | 1,204.5 | | | $ | 7,439.4 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Three Months Ended June 30, 2023 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 1,300.2 | | | $ | 530.5 | | | $ | 207.4 | | | $ | 406.6 | | | $ | 2,444.7 | |
| | | | | | | | | |
Generics | 1,053.6 | | | 1.6 | | | 168.1 | | | 241.5 | | | 1,464.8 | |
Total Viatris | $ | 2,353.8 | | | $ | 532.1 | | | $ | 375.5 | | | $ | 648.1 | | | $ | 3,909.5 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Six Months Ended June 30, 2023 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 2,532.2 | | | $ | 1,092.9 | | | $ | 397.7 | | | $ | 842.2 | | | $ | 4,865.0 | |
| | | | | | | | | |
Generics | 1,992.0 | | | 3.8 | | | 320.0 | | | 447.8 | | | 2,763.6 | |
Total Viatris | $ | 4,524.2 | | | $ | 1,096.7 | | | $ | 717.7 | | | $ | 1,290.0 | | | $ | 7,628.6 | |
___________
(a)Amounts for the three and six months ended June 30, 2024 include the impact of foreign currency translations and divested businesses compared to the prior year period.
(b)Complex Gx, which were previously presented as a separate line item in the prior year period, are now included within Generics. Reclassifications were made to prior periods to conform to the current period presentation.
The following table presents net sales on a consolidated basis for select key products for the three and six months ended June 30, 2024 and 2023, respectively:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, 2024 |
(In millions) | | 2024 | | 2023 | | 2024 | | 2023 |
Select Key Global Products | | | | | | | | |
Lipitor ® | | $ | 348.4 | | | $ | 380.0 | | | $ | 737.3 | | | $ | 797.9 | |
Norvasc ® | | 161.9 | | | 182.4 | | | 338.2 | | | 385.1 | |
Lyrica ® | | 124.3 | | | 137.1 | | | 238.5 | | | 281.4 | |
EpiPen® Auto-Injectors | | 115.5 | | | 127.5 | | | 195.7 | | | 223.3 | |
Viagra ® | | 106.1 | | | 111.0 | | | 206.8 | | | 226.0 | |
Creon ® | | 78.2 | | | 74.1 | | | 153.2 | | | 146.8 | |
Celebrex ® | | 72.2 | | | 82.0 | | | 144.4 | | | 170.8 | |
Effexor ® | | 62.7 | | | 64.8 | | | 122.1 | | | 129.4 | |
Zoloft ® | | 58.9 | | | 54.5 | | | 116.9 | | | 111.0 | |
Xalabrands | | 45.6 | | | 50.4 | | | 88.1 | | | 97.1 | |
| | | | | | | | |
Select Key Segment Products | | | | | | | | |
| | | | | | | | |
Dymista ® | | $ | 55.0 | | | $ | 57.7 | | | $ | 103.2 | | | $ | 110.9 | |
Yupelri ® | | 54.5 | | | 55.0 | | | 109.7 | | | 102.0 | |
Amitiza ® | | 36.9 | | | 41.5 | | | 69.9 | | | 78.1 | |
Xanax ® | | 35.4 | | | 51.8 | | | 69.9 | | | 91.5 | |
____________
(a)The Company does not disclose net sales for any products considered competitively sensitive.
(b)Products disclosed may change in future periods, including as a result of seasonality, competition or new product launches.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
(c)Amounts for the three and six months ended June 30, 2024 include the impact of foreign currency translations compared to the prior year period.
(d)Refer to intellectual property matters included in Note 17 Litigation for additional information regarding Yupelri® and Amitiza®.
Variable Consideration and Accounts Receivable
The following table presents a reconciliation of gross sales to net sales by each significant category of variable consideration during the three and six months ended June 30, 2024 and 2023, respectively:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, | | June 30, |
(In millions) | 2024 | | 2023 | | 2024 | | 2023 |
Gross sales | $ | 6,383.9 | | | $ | 6,519.0 | | | $ | 12,558.5 | | | $ | 12,792.0 | |
Gross to net adjustments: | | | | | | | |
Chargebacks | (1,282.6) | | | (1,374.2) | | | (2,526.8) | | | (2,724.9) | |
Rebates, promotional programs and other sales allowances | (1,040.5) | | | (961.0) | | | (2,088.8) | | | (1,953.2) | |
Returns | (70.1) | | | (68.3) | | | (130.4) | | | (118.7) | |
Governmental rebate programs | (204.8) | | | (206.0) | | | (373.1) | | | (366.6) | |
Total gross to net adjustments | $ | (2,598.0) | | | $ | (2,609.5) | | | $ | (5,119.1) | | | $ | (5,163.4) | |
Net sales | $ | 3,785.9 | | | $ | 3,909.5 | | | $ | 7,439.4 | | | $ | 7,628.6 | |
No significant revisions were made to the methodology used in determining these provisions or the nature of the provisions during the three and six months ended June 30, 2024. Such allowances were comprised of the following at June 30, 2024 and December 31, 2023, respectively:
| | | | | | | | | | | |
(In millions) | June 30, 2024 | | December 31, 2023 |
Accounts receivable, net | $ | 1,552.9 | | | $ | 1,483.6 | |
Other current liabilities | 994.1 | | | 996.3 | |
Total | $ | 2,547.0 | | | $ | 2,479.9 | |
Accounts receivable, net was comprised of the following at June 30, 2024 and December 31, 2023, respectively:
| | | | | | | | | | | |
(In millions) | June 30, 2024 | | December 31, 2023 |
Trade receivables, net | $ | 2,684.4 | | | $ | 2,823.8 | |
Other receivables | 882.5 | | | 876.6 | |
Accounts receivable, net | $ | 3,566.9 | | | $ | 3,700.4 | |
Accounts Receivable Factoring Arrangements
We have entered into accounts receivable factoring agreements with financial institutions to sell certain of our non-U.S. accounts receivable. These transactions are accounted for as sales and result in a reduction in accounts receivable because the agreements transfer effective control over and risk related to the receivables to the buyers. Our factoring agreements do not allow for recourse in the event of uncollectibility, and we do not retain any interest in the underlying accounts receivable once sold. We derecognized $59.8 million and $30.8 million of accounts receivable as of June 30, 2024 and December 31, 2023, respectively, under these factoring arrangements. Additionally, in 2023, we entered into a similar arrangement for certain European countries. As of June 30, 2024 and December 31, 2023, we have assigned and derecognized approximately $375.2 million and $415.7 million, respectively, of Trade Receivables, Net, which are now included in Other Receivables.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
3.Recent Accounting Pronouncements
Accounting Standards and Disclosure Rules Issued Not Yet Adopted
In March 2024, the SEC adopted final rules under SEC Release No. 34-99678 and No. 33-11275, “The Enhancement and Standardization of Climate-Related Disclosures for Investors” (the “Final Rules”), which will require registrants to provide certain climate-related information in their registration statements and annual reports. The Final Rules require, among other things, disclosure in the notes to the audited financial statements of the effects of severe weather events and other natural conditions, subject to certain thresholds, as well as amounts related to carbon offsets and renewable energy credits or certificates in certain circumstances. The Final Rules will also require disclosure outside of the financial statements of material scope 1 and scope 2 greenhouse gas emissions, among other climate-related disclosures. The disclosure requirements of the Final Rules will begin phasing in for the Company for fiscal year 2025. In April 2024, the SEC stayed the effectiveness of the Final Rules. The Company is currently assessing the impact of the new rules on its consolidated financial statements and disclosures.
There were no other significant changes in new accounting standards from those disclosed in Viatris’ 2023 Form 10-K. Refer to Viatris’ 2023 Form 10-K for additional information.
4.Acquisitions and Other Transactions
Idorsia
On March 15, 2024, the Company acquired the development programs and certain personnel related to selatogrel and cenerimod from Idorsia in exchange for an upfront payment to Idorsia of $350 million, potential milestone payments (including $300 million payable upon the achievement of certain development and regulatory milestones, and $2.1 billion payable upon the achievement of certain tiered sales milestones), as well as potential contingent tiered sales royalties. Viatris and Idorsia are both contributing to the development costs for both programs. Viatris has worldwide commercialization rights for both selatogrel and cenerimod (excluding, for cenerimod only, Japan, South Korea and certain countries in the Asia-Pacific region). A joint development committee is overseeing the development of the ongoing Phase 3 programs through regulatory approval. The agreements also provide Viatris a right of first refusal and a right of first negotiation for certain other assets in Idorsia’s pipeline. The transaction expands our portfolio of innovative assets by adding two Phase 3 assets and combines our financial strength and worldwide operational infrastructure with Idorsia’s proven, highly-productive drug development team and innovation engine.
In accordance with U.S. GAAP, the transaction has been accounted for as a business combination under the acquisition method of accounting. Under the acquisition method of accounting, the assets acquired and liabilities assumed in the transaction were recorded at their respective estimated fair values at the acquisition date. During the six months ended June 30, 2024, the Company incurred acquisition-related costs of approximately $3.9 million, which were recorded primarily in SG&A in the condensed consolidated statements of operations.
The U.S. GAAP purchase price allocated to the transaction was $695 million, which consisted of $350 million of cash consideration paid and estimated contingent consideration at the date of acquisition valued at approximately $345 million. The fair value of the contingent consideration was valued using a Monte Carlo simulation model using Level 3 inputs. The fair value is sensitive to changes in the forecasts of operating metrics, probability of success, and discount rates. Refer to Note 11, Financial Instruments and Risk Management, for additional information. The preliminary allocation of the purchase price to the assets acquired and liabilities assumed is as follows:
| | | | | | | | | |
(In millions) | | | | | |
Current assets | $ | 2.1 | | | | | |
| | | | | |
IPR&D | 675.0 | | | | | |
Goodwill | 19.5 | | | | | |
| | | | | |
Total assets acquired | $ | 696.6 | | | | | |
Current liabilities | 1.6 | | | | | |
| | | | | |
| | | | | |
Net assets acquired | $ | 695.0 | | | | | |
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The preliminary fair value estimates for the assets acquired and liabilities assumed were based upon preliminary calculations, valuations and assumptions that are subject to change as the Company obtains additional information during the measurement period (up to one year from the acquisition date). The primary areas subject to change relate to the finalization of the valuation of IPR&D, contingent consideration, and income taxes.
The amount allocated to IPR&D represents an estimate of the fair value of purchased in-process technology for research projects that, as of the closing date of the acquisition, had not reached technological feasibility and had no alternative future use. The fair value of IPR&D of $675 million was based on the excess earnings method, which utilizes forecasts of expected cash inflows (including estimates for ongoing costs) and other contributory charges. A discount rate of 20% was utilized to discount net cash inflows to present values. IPR&D is accounted for as an indefinite-lived intangible asset and will be subject to impairment testing until completion or abandonment of the projects. Upon successful completion and launch of each product, the Company will make a determination of the estimated useful life of the individual asset. Viatris and Idorsia will both contribute to the development costs for both programs, which are expected to be incurred through 2026. There are risks and uncertainties associated with the timely and successful completion of the projects included in IPR&D, and no assurances can be given that the underlying assumptions used to estimate the fair value of IPR&D will not change or the timely completion of each project to commercial success will occur.
The goodwill of $19.5 million arising from the acquisition consisted largely of the value of the employee workforce and the expected value of products to be developed in the future. All of the goodwill was assigned to the Developed Markets segment. None of the goodwill recognized in this transaction is currently expected to be deductible for income tax purposes. The acquisition did not have a material impact on the Company’s results of operations since the acquisition date or on a pro forma basis for the three and six months ended June 30, 2024 and 2023.
5.Divestitures
On October 1, 2023, the Company announced it received an offer for the divestiture of its OTC Business, and entered into definitive agreements to divest its women’s healthcare business and, separately, in another transaction, its rights to two women’s healthcare products in certain countries, its API business in India and commercialization rights in the Upjohn Distributor Markets. The OTC, API and women’s healthcare businesses are deemed businesses for U.S. GAAP accounting purposes. As such, the assets and liabilities include an allocation of goodwill. The sale of the rights to two women’s healthcare products in certain countries was accounted for as an asset sale. In conjunction with these transactions, Viatris and the respective buyers have entered into various agreements to provide a framework for our relationship with the respective buyers after the closing of the divestitures, including transition services agreements, manufacturing and supply agreements, and distribution agreements, as necessary.
During the three months ended June 30, 2024 and 2023, the Company recognized TSA income related to the divestitures of approximately $6.0 million and $46.9 million, respectively. During the six months ended June 30, 2024 and 2023, the Company recognized TSA income related to the divestitures of approximately $19.5 million and $92.6 million, respectively. TSA income is recorded as a component of Other Expense (Income), Net.
Women’s Healthcare
In the third quarter of 2023, Viatris executed an agreement to divest its women’s healthcare business to Insud Pharma, S. L., a leading Spanish multinational pharmaceutical company. The divestiture of the women’s healthcare business is primarily related to our oral and injectable contraceptives and does not include all of our women’s healthcare related products; as an example, our Xulane® product in the U.S. is excluded. The transaction includes two manufacturing facilities in India. Assets and liabilities associated with the women’s healthcare business divested were classified as held for sale in the consolidated balance sheet as of December 31, 2023. The transaction closed in March 2024 and upon closing, the Company recognized a pre-tax gain on sale of approximately $80.8 million in that quarter for the difference between the consideration received and the carrying value of the assets transferred (including an allocation of goodwill). The gain was recorded as a component of Other Expense (Income), Net in the condensed consolidated statement of operations during the six months ended June 30, 2024.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
In the third quarter of 2023, Viatris also entered into a separate agreement to divest its rights to women’s healthcare products Duphaston® and Femoston® in certain countries to Theramex HQ UK Limited, a leading global specialty pharmaceutical company dedicated to women’s health. The transaction (other than in the U.K., which remains subject to regulatory approval) closed in December 2023, and upon closing, the Company recognized a pre-tax gain on sale of approximately $156.2 million in that quarter for the difference between the consideration received and the carrying value of the assets transferred. The gain was recorded as a component of SG&A expense in the consolidated statement of operations during the year ended December 31, 2023.
OTC
On October 1, 2023, Viatris received an offer from Cooper Consumer Health SAS, a leading European OTC drug manufacturer and distributor, for Viatris to divest its OTC Business, including two manufacturing sites located in Merignac, France, and Confienza, Italy, and an R&D site in Monza, Italy. In January 2024, we exercised our option to accept the offer in the OTC Transaction and entered into a definitive transaction agreement with respect to such OTC Transaction. The Company retained the rights for Viagra®, Dymista® (which, in certain limited markets, are sold as OTC products) and select OTC products in certain markets. The OTC Transaction closed on July 3, 2024.
The OTC Business divested met the criteria to be classified as held for sale on October 1, 2023. As such, the related assets and liabilities were classified as held for sale in the condensed consolidated balance sheets as of June 30, 2024 and December 31, 2023. Upon classification as held for sale in the fourth quarter of 2023, we recognized a total charge of approximately $734.7 million, which was comprised of a goodwill impairment charge of approximately $580.1 million (recorded as a component of SG&A expense), and a charge of approximately $154.7 million to write down the disposal group to fair value, less cost to sell (recorded as a component of Other Income, Net) in the consolidated statement of operations. During the three and six months ended June 30, 2024, the Company recorded an additional pre-tax charge of approximately $247.6 million to further write down the disposal group to fair value, less cost to sell. The additional charge was recorded as a component of Other Expense (Income), Net in the condensed consolidated statement of operations, and was primarily due to an increase in estimated transaction related costs, including the assumption of additional contractual obligations, as well as the impact of working capital and other transaction related adjustments on the estimated proceeds.
API
On October 1, 2023, Viatris executed an agreement to divest its API business in India to Matrix Pharma Private Limited, a privately held pharmaceutical company based in India. The transaction includes three manufacturing sites and a R&D lab in Hyderabad, three manufacturing sites in Vizag and third-party API sales. Viatris will retain some selective R&D capabilities in API. The transaction closed in June 2024. The API business in India met the criteria to be classified as held for sale on October 1, 2023 and the related assets and liabilities were reclassified as held for sale in the consolidated balance sheet as of December 31, 2023. During the three and six months ended June 30, 2024, the Company recognized a pre-tax charge of approximately $7.0 million and $17.4 million, respectively, to write down the disposal group to fair value, less cost to sell (recorded as a component of Other Expense (Income), Net) in the condensed consolidated statement of operations.
Upjohn Distributor Markets
In the fourth quarter of 2022, the commercialization rights in the Upjohn Distributor Markets met the criteria to be classified as held for sale. Upon classification as held for sale, the Company recognized a total charge of $374.2 million in 2022, which was comprised of a goodwill impairment charge of $117.0 million, other charges, principally inventory write-offs, of $84.3 million and a charge of approximately $172.9 million to write down the disposal group to fair value, less cost to sell. During the three and six months ended June 30, 2023, the Company recorded additional charges of $10.0 million and $19.2 million, respectively. During the six months ended June 30, 2023, the Company additionally recorded an intangible asset charge of $32.0 million to write down the disposal group to fair value, less cost to sell. Total charges during the year ended December 31, 2023 amounted to $136.4 million, primarily consisting of losses on the disposals of $85.2 million, which were recorded as a component of Other Income, Net. The divestitures of the commercialization rights in certain of the Upjohn Distributor Markets closed during 2023 and 2024, and the remaining transactions are expected to be completed during 2024. If the remaining transactions are not completed, the distribution arrangements will expire in accordance with our agreement with Pfizer and the Company will wind down operations in these markets, which may result in additional asset write-offs and other costs being incurred.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
Biocon Biologics Transaction
On November 29, 2022, Viatris completed a transaction to contribute its biosimilars portfolio to Biocon Biologics. Under the terms of the Biocon Agreement, Viatris received $3 billion in consideration in the form of a $2 billion cash payment, adjusted as set forth in the Biocon Agreement, and approximately $1 billion of CCPS representing a stake of approximately 12.9% (on a fully diluted basis) in Biocon Biologics. During the three months ended June 30, 2024 and 2023, the Company recorded a gain of $282.4 million and $28.9 million, respectively, and during the six months ended June 30, 2024 and 2023, the Company recognized a gain of $329.3 million and $31.5 million, respectively, as a result of remeasuring the CCPS in Biocon Biologics to fair value. The increase is primarily related to changes in certain market factors, including Biocon’s share price. The Company’s CCPS in Biocon Biologics are classified as equity securities and are included in Other Assets in the condensed consolidated balance sheets, and gains and losses recorded as a result of remeasuring the CCPS in Biocon Biologics to fair value are recorded as a component of Other Expense (Income), Net. The fair value is reassessed quarterly. Refer to Note 11 Financial Instruments and Risk Management for further discussion. Viatris received $145 million during the six months ended June 30, 2024. In addition, Viatris and Biocon Biologics have agreed to a closing working capital target of $250 million, of which $220 million was paid during 2023. Viatris and Biocon Biologics have tentatively agreed to offset certain amounts due between the parties, including the remaining working capital target amount. The Company is entitled to an additional $160 million in cash payments in the fourth quarter of 2024 as deferred consideration pursuant to the terms of the Biocon Agreement. Refer to Note 8 Balance Sheet Components for additional information on assets and liabilities related to Biocon Biologics.
At the time of closing of the Biocon Biologics Transaction, Viatris and Biocon Biologics also entered an agreement pursuant to which Viatris was providing commercialization and certain other transition services on behalf of Biocon Biologics, including billings, collections, and the remittance of rebates, to ensure business continuity for patients, customers and colleagues. Biocon Biologics had substantially exited all transition services with Viatris as of December 31, 2023.
Assets and Liabilities Held for Sale
Assets and liabilities held for sale consisted of the following:
| | | | | | | | | | | | | | |
(In millions) | | June 30, 2024 | | December 31, 2023 |
Assets held for sale | | | | |
Accounts receivable, net | | $ | (2.8) | | | $ | 112.1 | |
Inventories | | 136.6 | | | 422.4 | |
Prepaid expenses and other current assets | | 1.9 | | | 7.5 | |
Property, plant and equipment, net | | 46.3 | | | 262.2 | |
Intangible assets, net | | |