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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, 2023
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 2, 2023 was 1,199,532,495.
VIATRIS INC. AND SUBSIDIARIES
INDEX TO FORM 10-Q
For the Quarterly Period Ended
June 30, 2023
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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 |
2022 Form 10-K | Viatris’ annual report on Form 10-K for the fiscal year ended December 31, 2022, 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 |
AOCE | Accumulated other comprehensive earnings |
API | Active pharmaceutical ingredient |
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 by that certain Amendment No. 1 to Transaction Agreement, dated November 28, 2022 and that certain Omnibus Amendment No. 1, dated May 17, 2023 |
Biogen | Biogen MA Inc. and Biogen International GmbH, collectively |
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 |
CCPS | Compulsory convertible preferred shares |
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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 |
COVID-19 | Novel coronavirus disease of 2019 |
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. |
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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 net contribution attributable to equity method investments, income tax provision (benefit), interest expense and depreciation and amortization |
EDPA | U.S. District Court for the Eastern District of Pennsylvania |
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 |
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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, 2023 |
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 |
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 |
LIBOR | London Interbank Offered Rate |
Lilly | Eli Lilly and Company |
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 |
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Mylan | Mylan N.V. and its subsidiaries |
Mylan Inc. U.S. Dollar Notes | The 4.200% Senior Notes due 2023, 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. |
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NASDAQ | The NASDAQ Stock Market |
NDA | New drug application |
NHS | National Health Services |
Note Securitization Facility | The note securitization facility entered into in August 2022 for borrowings up to $200 million and expiring in August 2023 |
OTC | Over-the-counter |
Oyster Point | Oyster Point Pharma, Inc. |
Pfizer | Pfizer Inc. |
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PSUs | Performance awards |
R&D | Research and development |
Receivables Facility | The $400 million accounts receivable 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 |
RSUs | The Company's unvested restricted stock unit awards |
Sanofi | Sanofi-Aventis U.S., LLC |
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 |
SOFR | Secured overnight financial rate |
Stock awards | Stock options and SARs |
Teva | Teva Pharmaceutical Industries Ltd. |
TSA | Transition services agreement |
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 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, |
| 2023 | | 2022 | | 2023 | | 2022 |
Revenues: | | | | | | | |
Net sales | $ | 3,909.5 | | | $ | 4,105.4 | | | $ | 7,628.6 | | | $ | 8,283.6 | |
Other revenues | 9.1 | | | 11.4 | | | 19.1 | | | 24.9 | |
Total revenues | 3,918.6 | | | 4,116.8 | | | 7,647.7 | | | 8,308.5 | |
Cost of sales | 2,310.0 | | | 2,413.5 | | | 4,496.9 | | | 4,834.0 | |
Gross profit | 1,608.6 | | | 1,703.3 | | | 3,150.8 | | | 3,474.5 | |
Operating expenses: | | | | | | | |
Research and development | 208.3 | | | 162.6 | | | 391.2 | | | 304.9 | |
Acquired IPR&D | 10.2 | | | — | | | 10.2 | | | — | |
Selling, general and administrative | 1,031.9 | | | 981.1 | | | 1,990.8 | | | 1,896.4 | |
Litigation settlements and other contingencies, net | (11.0) | | | 10.9 | | | (10.4) | | | 17.1 | |
Total operating expenses | 1,239.4 | | | 1,154.6 | | | 2,381.8 | | | 2,218.4 | |
Earnings from operations | 369.2 | | | 548.7 | | | 769.0 | | | 1,256.1 | |
Interest expense | 143.7 | | | 145.9 | | | 290.7 | | | 292.1 | |
Other (income) expense, net | (107.5) | | | 13.5 | | | (177.4) | | | 47.2 | |
Earnings before income taxes | 333.0 | | | 389.3 | | | 655.7 | | | 916.8 | |
Income tax provision | 69.0 | | | 75.4 | | | 167.0 | | | 203.7 | |
Net earnings | $ | 264.0 | | | $ | 313.9 | | | $ | 488.7 | | | $ | 713.1 | |
Earnings per share attributable to Viatris Inc. shareholders | | | | | | | |
Basic | $ | 0.22 | | | $ | 0.26 | | | $ | 0.41 | | | $ | 0.59 | |
Diluted | $ | 0.22 | | | $ | 0.26 | | | $ | 0.41 | | | $ | 0.59 | |
Weighted average shares outstanding: | | | | | | | |
Basic | 1,199.0 | | | 1,212.3 | | | 1,200.8 | | | 1,211.4 | |
Diluted | 1,203.5 | | | 1,217.1 | | | 1,204.6 | | | 1,215.1 | |
See Notes to Condensed Consolidated Financial Statements
7
VIATRIS INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Comprehensive Earnings (Loss)
(Unaudited; in millions)
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, | | June 30, |
| 2023 | | 2022 | | 2023 | | 2022 |
Net earnings | $ | 264.0 | | | $ | 313.9 | | | $ | 488.7 | | | $ | 713.1 | |
Other comprehensive loss, before tax: | | | | | | | |
Foreign currency translation adjustment | (254.1) | | | (1,149.9) | | | (208.8) | | | (1,619.1) | |
Change in unrecognized (loss) gain and prior service cost related to defined benefit plans | (6.8) | | | 0.5 | | | (5.5) | | | (2.1) | |
Net unrecognized gain on derivatives in cash flow hedging relationships | 36.8 | | | 17.6 | | | 39.6 | | | 17.8 | |
Net unrecognized (loss) gain on derivatives in net investment hedging relationships | (12.8) | | | 384.4 | | | (79.0) | | | 585.7 | |
Net unrealized gain (loss) on marketable securities | 0.2 | | | (1.0) | | | 1.1 | | | (2.7) | |
Other comprehensive loss, before tax | (236.7) | | | (748.4) | | | (252.6) | | | (1,020.4) | |
Income tax provision (benefit) | 4.3 | | | 89.8 | | | (8.2) | | | 134.5 | |
Other comprehensive loss, net of tax | (241.0) | | | (838.2) | | | (244.4) | | | (1,154.9) | |
Comprehensive earnings (loss) | $ | 23.0 | | | $ | (524.3) | | | $ | 244.3 | | | $ | (441.8) | |
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, 2023 | | December 31, 2022 |
ASSETS |
Assets | | | |
Current assets: | | | |
Cash and cash equivalents | $ | 629.2 | | | $ | 1,259.9 | |
Accounts receivable, net | 3,607.3 | | | 3,814.5 | |
Inventories | 3,641.5 | | | 3,519.5 | |
Prepaid expenses and other current assets | 1,725.1 | | | 1,811.2 | |
Assets held for sale | 174.9 | | | 230.3 | |
Total current assets | 9,778.0 | | | 10,635.4 | |
Property, plant and equipment, net | 2,983.2 | | | 3,024.5 | |
Intangible assets, net | 22,084.4 | | | 22,607.1 | |
Goodwill | 10,532.5 | | | 10,425.8 | |
Deferred income tax benefit | 966.0 | | | 925.9 | |
Other assets | 2,351.1 | | | 2,403.5 | |
Total assets | $ | 48,695.2 | | | $ | 50,022.2 | |
| | | |
LIABILITIES AND EQUITY |
Liabilities | | | |
Current liabilities: | | | |
Accounts payable | $ | 1,962.0 | | | $ | 1,766.6 | |
Short-term borrowings | 23.2 | | | — | |
Income taxes payable | 158.1 | | | 279.6 | |
Current portion of long-term debt and other long-term obligations | 1,334.4 | | | 1,259.1 | |
| | | |
Other current liabilities | 3,046.1 | | | 3,440.9 | |
Total current liabilities | 6,523.8 | | | 6,746.2 | |
Long-term debt | 17,246.0 | | | 18,015.2 | |
Deferred income tax liability | 2,407.8 | | | 2,432.0 | |
Other long-term obligations | 1,674.3 | | | 1,756.5 | |
Total liabilities | 27,851.9 | | | 28,949.9 | |
Equity | | | |
Viatris Inc. shareholders’ equity | | | |
Common stock: $0.01 par value, 3,000,000,000 shares authorized; shares issued: 1,220,385,566 and 1,213,793,231, respectively | 12.2 | | | 12.1 | |
Additional paid-in capital | 18,719.4 | | | 18,645.8 | |
Retained earnings | 5,369.1 | | | 5,175.6 | |
Accumulated other comprehensive loss | (3,005.6) | | | (2,761.2) | |
| 21,095.1 | | | 21,072.3 | |
| | | |
Less: Treasury stock — at cost | | | |
Common stock shares: 21,239,521 as of June 30, 2023 | 251.8 | | | — | |
Total equity | 20,843.3 | | | 21,072.3 | |
| | | |
Total liabilities and equity | $ | 48,695.2 | | | $ | 50,022.2 | |
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, 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
10
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Ordinary Shares (1) | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at March 31, 2022 | 1,212,323,483 | | | $ | 12.1 | | | $ | 18,555.1 | | | $ | 3,941.5 | | | — | | | $ | — | | | $ | (2,061.0) | | | | | $ | 20,447.7 | |
Net earnings | — | | | — | | | — | | | 313.9 | | | — | | | — | | | — | | | | | 313.9 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (838.2) | | | | | (838.2) | |
Issuance of restricted stock, net | 64,292 | | | — | | | — | | | — | | | — | | | — | | | — | | | | | — | |
Taxes related to the net share settlement of equity awards | — | | | — | | | 0.5 | | | — | | | — | | | — | | | — | | | | | 0.5 | |
Share-based compensation expense | — | | | — | | | 29.4 | | | — | | | — | | | — | | | — | | | | | 29.4 | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Issuance of common stock | 59,682 | | | — | | | 0.7 | | | — | | | — | | | — | | | — | | | | | 0.7 | |
Cash dividends declared, $0.12 per common share | — | | | — | | | — | | | (148.6) | | | — | | | — | | | — | | | | | (148.6) | |
| | | | | | | | | | | | | | | | | |
Balance at June 30, 2022 | 1,212,447,457 | | | $ | 12.1 | | | $ | 18,585.7 | | | $ | 4,106.8 | | | — | | | $ | — | | | $ | (2,899.2) | | | | | $ | 19,805.4 | |
| | | | | | | | | | | | | | | | | |
| | | | | Additional Paid-In Capital | | Retained Earnings | | | | | | Accumulated Other Comprehensive Loss | | | | Total Equity |
| Common Stock | | | | Treasury Stock | | | |
| Shares | | Cost | | | | Shares | | Cost | | | |
Balance at December 31, 2021 | 1,209,507,463 | | | $ | 12.1 | | | $ | 18,536.1 | | | $ | 3,688.8 | | | — | | | $ | — | | | $ | (1,744.3) | | | | | $ | 20,492.7 | |
Net earnings | — | | | — | | | — | | | 713.1 | | | — | | | — | | | — | | | | | 713.1 | |
Other comprehensive loss, net of tax | — | | | — | | | — | | | — | | | — | | | — | | | (1,154.9) | | | | | (1,154.9) | |
Issuance of restricted stock, net | 2,880,312 | | | — | | | — | | | — | | | — | | | — | | | — | | | | | — | |
Taxes related to the net share settlement of equity awards | — | | | — | | | (8.8) | | | — | | | — | | | — | | | — | | | | | (8.8) | |
Share-based compensation expense | — | | | — | | | 57.7 | | | — | | | — | | | — | | | — | | | | | 57.7 | |
| | | | | | | | | | | | | | | | | |
| | | | | | | | | | | | | | | | | |
Issuance of common stock | 59,682 | | | — | | | 0.7 | | | — | | | — | | | — | | | — | | | | | 0.7 | |
Cash dividends declared, $0.24 per common share | — | | | — | | | — | | | (295.1) | | | — | | | — | | | — | | | | | (295.1) | |
| | | | | | | | | | | | | | | | | |
Balance at June 30, 2022 | 1,212,447,457 | | | $ | 12.1 | | | $ | 18,585.7 | | | $ | 4,106.8 | | | — | | | $ | — | | | $ | (2,899.2) | | | | | $ | 19,805.4 | |
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, |
| 2023 | | 2022 |
Cash flows from operating activities: | | | |
Net earnings | $ | 488.7 | | | $ | 713.1 | |
Adjustments to reconcile net earnings to net cash provided by operating activities: | | | |
Depreciation and amortization | 1,416.7 | | | 1,458.3 | |
Share-based compensation expense | 81.8 | | | 57.7 | |
Deferred income tax benefit | (94.9) | | | (157.6) | |
| | | |
Other non-cash items | 42.9 | | | 3.8 | |
Litigation settlements and other contingencies, net | (6.3) | | | 10.0 | |
Changes in operating assets and liabilities: | | | |
Accounts receivable | 69.2 | | | (142.3) | |
Inventories | (266.5) | | | (270.1) | |
Accounts payable | 192.7 | | | 254.5 | |
Income taxes | (22.1) | | | 17.8 | |
Other operating assets and liabilities, net | (416.1) | | | (4.2) | |
Net cash provided by operating activities | 1,486.1 | | | 1,941.0 | |
Cash flows from investing activities: | | | |
Cash paid for acquisitions, net of cash acquired | (667.7) | | | — | |
Capital expenditures | (115.6) | | | (148.4) | |
Purchase of marketable securities | (16.6) | | | (13.2) | |
Proceeds from the sale of marketable securities | 16.6 | | | 12.8 | |
Payments for product rights and other, net | (55.9) | | | (13.0) | |
| | | |
Proceeds from sale of property, plant and equipment | 13.1 | | | 12.8 | |
Net cash used in investing activities | (826.1) | | | (149.0) | |
Cash flows from financing activities: | | | |
Proceeds from issuance of long-term debt | — | | | 795.4 | |
Payments of long-term debt | (750.1) | | | (1,787.0) | |
Purchase of common stock | (250.0) | | | — | |
Change in short-term borrowings, net | 23.1 | | | (473.5) | |
Taxes paid related to net share settlement of equity awards | (30.0) | | | (13.2) | |
Contingent consideration payments | (8.4) | | | (18.9) | |
Payments of financing fees | — | | | (1.3) | |
Cash dividends paid | (287.7) | | | (290.6) | |
Non-contingent payments for product rights | (9.7) | | | — | |
Issuance of common stock | 1.7 | | | 0.7 | |
Other items, net | 32.9 | | | (0.2) | |
Net cash used in financing activities | (1,278.2) | | | (1,788.6) | |
Effect on cash of changes in exchange rates | (12.9) | | | (40.2) | |
Net decrease in cash, cash equivalents and restricted cash | (631.1) | | | (36.8) | |
Cash, cash equivalents and restricted cash — beginning of period | 1,262.5 | | | 706.2 | |
Cash, cash equivalents and restricted cash — end of period | $ | 631.4 | | | $ | 669.4 | |
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 earnings, 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’ 2022 Form 10-K. The December 31, 2022 condensed consolidated balance sheet was derived from audited financial statements.
The interim results of operations and comprehensive earnings for the three and six months ended June 30, 2023, and cash flows for the six months ended June 30, 2023, are not necessarily indicative of the results to be expected for the full fiscal year or any other future period.
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, 2023 and 2022, respectively:
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(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 | |
Complex Gx | 132.7 | | | — | | | 6.5 | | | — | | | 139.2 | |
Generics | 920.9 | | | 1.6 | | | 161.6 | | | 241.5 | | | 1,325.6 | |
Total | $ | 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 | |
Complex Gx | 262.6 | | | — | | | 12.6 | | | 0.1 | | | 275.3 | |
Generics | 1,729.4 | | | 3.8 | | | 307.4 | | | 447.7 | | | 2,488.3 | |
Total | $ | 4,524.2 | | | $ | 1,096.7 | | | $ | 717.7 | | | $ | 1,290.0 | | | $ | 7,628.6 | |
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Three Months Ended June 30, 2022 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 1,305.4 | | | $ | 546.3 | | | $ | 243.1 | | | $ | 388.3 | | | $ | 2,483.1 | |
Complex Gx and Biosimilars | 327.0 | | | 0.3 | | | 12.1 | | | 15.4 | | | 354.8 | |
Generics | 846.7 | | | 1.7 | | | 171.9 | | | 247.2 | | | 1,267.5 | |
Total | $ | 2,479.1 | | | $ | 548.3 | | | $ | 427.1 | | | $ | 650.9 | | | $ | 4,105.4 | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
(In millions) | Six Months Ended June 30, 2022 |
Product Category | Developed Markets | | Greater China | | JANZ | | Emerging Markets | | Total |
Brands | $ | 2,604.1 | | | $ | 1,116.0 | | | $ | 492.1 | | | $ | 825.0 | | | $ | 5,037.2 | |
Complex Gx and Biosimilars | 691.1 | | | 0.3 | | | 22.4 | | | 31.8 | | | 745.6 | |
Generics | 1,660.0 | | | 5.1 | | | 336.4 | | | 499.3 | | | 2,500.8 | |
Total | $ | 4,955.2 | | | $ | 1,121.4 | | | $ | 850.9 | | | $ | 1,356.1 | | | $ | 8,283.6 | |
____________
(a)Amounts for the three and six months ended June 30, 2023 include the unfavorable impact of foreign currency translations compared to the prior year period.
(b)Amounts for the three and six months ended June 30, 2022 include $161.8 million and $326.6 million, respectively, related to the biosimilars business which was subsequently contributed to Biocon Biologics in November 2022. The Company has not recognized the results of the biosimilars business in its consolidated financial statements subsequent to November 29, 2022.
The following table presents net sales on a consolidated basis for select key products for the three and six months ended June 30, 2023 and 2022:
| | | | | | | | | | | | | | | | | | | | | | | | | | |
| | Three months ended June 30, | | Six months ended June 30, |
(In millions) | | 2023 | | 2022 | | 2023 | | 2022 |
Select Key Global Products | | | | | | | | |
Lipitor ® | | $ | 380.0 | | | $ | 405.6 | | | $ | 797.9 | | | $ | 845.7 | |
Norvasc ® | | 182.4 | | | 203.0 | | | 385.1 | | | 410.8 | |
Lyrica ® | | 137.1 | | | 155.8 | | | 281.4 | | | 327.4 | |
EpiPen® Auto-Injectors | | 127.5 | | | 106.5 | | | 223.3 | | | 195.3 | |
Viagra ® | | 111.0 | | | 115.1 | | | 226.0 | | | 244.9 | |
Celebrex ® | | 82.0 | | | 85.9 | | | 170.8 | | | 171.2 | |
Creon ® | | 74.1 | | | 75.4 | | | 146.8 | | | 150.1 | |
Effexor ® | | 64.8 | | | 73.7 | | | 129.4 | | | 151.2 | |
Zoloft ® | | 54.5 | | | 62.5 | | | 111.0 | | | 135.6 | |
Xalabrands | | 50.4 | | | 42.7 | | | 97.1 | | | 95.7 | |
| | | | | | | | |
Select Key Segment Products | | | | | | | | |
| | | | | | | | |
Dymista ® | | $ | 57.7 | | | $ | 55.5 | | | $ | 110.9 | | | $ | 99.4 | |
Yupelri ® | | 55.0 | | | 49.1 | | | 102.0 | | | 92.7 | |
Xanax ® | | 51.8 | | | 37.2 | | | 91.5 | | | 77.2 | |
Amitiza ® | | 41.5 | | | 44.1 | | | 78.1 | | | 85.9 | |
____________
(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.
(c)Amounts for the three and six months ended June 30, 2023 include the unfavorable impact of foreign currency translations compared to the prior year period.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
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, 2023 and 2022, respectively:
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
| June 30, | | June 30, |
(In millions) | 2023 | | 2022 | | 2023 | | 2022 |
Gross sales | $ | 6,519.0 | | | $ | 7,008.7 | | | $ | 12,792.0 | | | $ | 14,207.0 | |
Gross to net adjustments: | | | | | | | |
Chargebacks | (1,374.2) | | | (1,594.2) | | | (2,724.9) | | | (3,178.4) | |
Rebates, promotional programs and other sales allowances | (961.0) | | | (1,075.3) | | | (1,953.2) | | | (2,281.2) | |
Returns | (68.3) | | | (82.7) | | | (118.7) | | | (165.3) | |
Governmental rebate programs | (206.0) | | | (151.1) | | | (366.6) | | | (298.5) | |
Total gross to net adjustments | $ | (2,609.5) | | | $ | (2,903.3) | | | $ | (5,163.4) | | | $ | (5,923.4) | |
Net sales | $ | 3,909.5 | | | $ | 4,105.4 | | | $ | 7,628.6 | | | $ | 8,283.6 | |
____________
(a)Amounts for the three and six months ended June 30, 2022 include the biosimilars business which was subsequently contributed to Biocon Biologics in November 2022. The Company has not recognized the results of the biosimilars business in its consolidated financial statements subsequent to November 29, 2022.
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, 2023. Such allowances were comprised of the following at June 30, 2023 and December 31, 2022, respectively:
| | | | | | | | | | | |
(In millions) | June 30, 2023 | | December 31, 2022 |
Accounts receivable, net | $ | 1,575.5 | | | $ | 1,798.7 | |
Other current liabilities | 880.2 | | | 888.8 | |
Total | $ | 2,455.7 | | | $ | 2,687.5 | |
Accounts receivable, net was comprised of the following at June 30, 2023 and December 31, 2022, respectively:
| | | | | | | | | | | |
(In millions) | June 30, 2023 | | December 31, 2022 |
Trade receivables, net | $ | 3,123.7 | | | $ | 3,243.8 | |
Other receivables | 483.6 | | | 570.7 | |
Accounts receivable, net | $ | 3,607.3 | | | $ | 3,814.5 | |
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 $188.2 million and $34.7 million of accounts receivable as of June 30, 2023 and December 31, 2022, respectively, under these factoring arrangements.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
3.Recent Accounting Pronouncements
Adoption of New Accounting Standards
In September 2022, the FASB issued Accounting Standards Update 2022-04, Liabilities—Supplier Finance Programs (Subtopic 405-50), which requires entities to provide qualitative and quantitative disclosures about their supplier finance programs, including a rollforward of related obligations. The adoption of ASU 2022-04 did not affect the Company’s financial condition, results of operations or cash flows as the guidance only requires additional disclosures. We adopted this ASU effective January 1, 2023.
The Company has certain voluntary supply chain finance programs with financial intermediaries which provide participating suppliers the option to be paid by the intermediary earlier than the original invoice due date. The Company’s responsibility is limited to making payments on the terms originally negotiated with the suppliers, regardless of whether the intermediary pays the supplier in advance of the original due date. The range of payment terms the Company negotiates with suppliers are consistent, regardless of whether a supplier participates in a supply chain finance program. The total amounts due to financial intermediaries to settle supplier invoices under supply chain finance programs as of June 30, 2023 and December 31, 2022 were $55.6 million and $33.4 million, respectively. These amounts are included within Accounts payable in the condensed consolidated balance sheets.
There were no other significant changes in new accounting standards from those disclosed in Viatris’ 2022 Form 10-K. Refer to Viatris’ 2022 Form 10-K for additional information.
4.Acquisitions and Other Transactions
Oyster Point Acquisition
During the first quarter of 2023, the Company completed the acquisition of Oyster Point for approximately $427.4 million in cash, which included $11 per share paid to Oyster Point stockholders through a tender offer, payment for vested share-based awards, and the repayment of debt of Oyster Point. In addition to the upfront cash consideration, each Oyster Point stockholder received one non-tradeable contingent value right representing up to an additional $2 per share, or approximately $60 million in the aggregate, contingent upon Oyster Point achieving certain metrics based upon full year 2022 performance. Oyster Point did not achieve the metrics that would have triggered a contingent payment and the contingent value rights have expired. Oyster Point is focused on the discovery, development, and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases.
Vested share-based awards to acquire Oyster Point common stock that were outstanding immediately prior to the closing of the acquisition were cancelled in exchange for the right to receive an amount in cash based upon a formula contained within the merger agreement. The unvested share-based awards were converted into Viatris share-based awards based upon a formula contained within the merger agreement.
In accordance with U.S. GAAP, the Company used the acquisition method of accounting to account for this transaction. 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, 2023, the Company incurred acquisition related costs of approximately $19.8 million, which were recorded primarily in SG&A in the condensed consolidated statement of operations.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
The U.S. GAAP purchase price was $392.7 million, net of cash acquired. The preliminary allocation of the purchase price to the assets acquired and liabilities assumed for Oyster Point is as follows:
| | | | | |
(In millions) | |
Current assets (excluding inventories and net of cash acquired) | $ | 26.9 | |
Inventories | 37.8 | |
Property, plant and equipment | 1.4 | |
Identified intangible assets | 334.0 | |
Goodwill | 5.9 | |
Deferred income tax benefit | 17.7 | |
Other assets | 7.7 | |
Total assets acquired | $ | 431.4 | |
Current liabilities | 37.0 | |
| |
Other noncurrent liabilities | 1.7 | |
Net assets acquired (net of $34.7 of cash acquired) | $ | 392.7 | |
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 intangible assets and income taxes. There were no changes to the fair value estimates in the second quarter of 2023.
The Company recorded a step-up in the fair value of inventory of approximately $29.3 million. During the three and six months ended June 30, 2023, the Company recorded amortization of the inventory step-up of approximately $7.3 million and $14.7 million, respectively, which is included in Cost of sales in the condensed consolidated statement of operations.
The identified intangible assets of $334.0 million are comprised of product rights and licenses related to a commercial asset, Tyrvaya®, for the treatment of dry eye disease, that have an estimated useful life of 10 years. Significant assumptions utilized in the valuation of identified intangible assets were based on company specific information and projections which are not observable in the market and are thus considered Level 3 measurements as defined by U.S. GAAP.
The goodwill of $5.9 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 operating results of Oyster Point have been included in the Company’s condensed consolidated statements of operations since the acquisition date. The total revenues of Oyster Point for the period from the acquisition date to June 30, 2023, were $16.5 million and net loss, net of tax, was approximately $85.8 million. The net loss for the period includes the effect of the purchase accounting adjustments and acquisition related costs.
The following table presents supplemental unaudited pro forma information for the acquisition, as if it had occurred on January 1, 2022. The unaudited pro forma results reflect certain adjustments related to past operating performance and acquisition accounting adjustments, such as increased amortization expense based on the fair value of assets acquired, the impact of transaction costs and the related income tax effects. The unaudited pro forma results do not include any anticipated synergies which may be achievable, or have been achieved, subsequent to the closing of the acquisition. Accordingly, the unaudited pro forma results are not necessarily indicative of the results that actually would have occurred had the acquisitions been completed on the stated date above, nor are they indicative of the future operating results of Viatris and its subsidiaries.
VIATRIS INC. AND SUBSIDIARIES
Notes to Condensed Consolidated Financial Statements (Unaudited) - Continued
| | | | | | | | | | | | | | | | | | | | | | | |
| Three Months Ended | | Six Months Ended |
(Unaudited, in millions, except per share amounts) | June 30, 2023 | | June 30, 2022 | | June 30, 2023 | | June 30, 2022 |
Total revenues | $ | 3,918.6 | | | $ | 4,121.5 | | | $ | 7,647.7 | | | $ | 8,315.9 | |
Net earnings | $ | 270.6 | | | $ | 264.4 | | | $ | 514.5 | | | $ | 601.4 | |
Earnings per share: | | | | | | | |
Basic | $ | 0.23 | | | $ | 0.22 | | | $ | 0.43 | | | $ | |