Enoxaparin Sodium

Reports Net Revenues of $178.1 Million for the Three Months Ended December 31, 2023 RANCHO CUCAMONGA, CA / ACCESSWIRE / February 28, 2024 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company") today reported results for the three months and full-year ended December 31, 2023. Fourth Quarter Highlights Net revenues of $178.1 million for the fourth quarter GAAP net income of $36.2 million, or $0.68 per share, for the fourth quarter Adjusted non-GAAP net income of $46.9 million, or $0.88 per share, for the fourth quarter Full-Year Highlights Net revenues of $644.4 million for the fiscal year GAAP net income of $137.5 million, or $2.60 per share, for the fiscal year Adjusted non-GAAP net income of $175.7 million, or $3.32 per share, for the fiscal year Dr. Jack Zhang, Amphastar's President and Chief Executive Officer, commented: "We enter 2024 with strong momentum. 2023 was an important year for the Company driven by the strong performance of glucagon and Primatene MIST ® alongside the acquisition of BAQSIMI ® , which strengthened our diabetes portfolio. The recent submission of our first BLA for Insulin Aspart, known as AMP-004, underscores our continued pipeline development in diabetes management, and marks another milestone for Amphastar." Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 (in thousands, except per share data) Net revenues $ 178,105 $ 135,023 $ 644,395 $ 498,987 GAAP net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Adjusted non-GAAP net income* $ 46,875 $ 37,638 $ 175,699 $ 103,186 GAAP diluted EPS $ 0.68 $ 0.66 $ 2.60 $ 1.74 Adjusted non-GAAP diluted EPS* $ 0.88 $ 0.73 $ 3.32 $ 1.97 ____________________________________ * Adjusted non-GAAP net income and adjusted non-GAAP diluted EPS are non-GAAP financial measures. Please see the discussion in the section entitled "Non-GAAP Financial Measures" and the reconciliation of GAAP to non-GAAP financial measures in Table III of this press release. Fourth Quarter Results Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Product revenues: Glucagon $ 31,198 $ 18,319 $ 12,879 70 % Epinephrine 24,646 21,427 3,219 15 % Primatene MIST® 24,484 22,279 2,205 10 % Lidocaine 14,988 13,286 1,702 13 % Phytonadione 11,922 11,666 256 2 % Enoxaparin 6,092 7,812 (1,720 ) (22 )% Naloxone 4,230 4,845 (615 ) (13 )% Other finished pharmaceutical products 35,015 33,082 1,933 6 % Total finished pharmaceutical products net revenues $ 152,575 $ 132,716 $ 19,859 15 % API 3,074 2,307 767 33 % Other revenues 22,456 - 22,456 N/A Total product revenues, net $ 178,105 $ 135,023 $ 43,082 32 % Changes in product revenues as compared to the fourth quarter of the prior year were primarily driven by: Glucagon sales increased primarily due to an increase in unit volumes, as a result of two competitors discontinuing their glucagon injection products at the end of 2022 Epinephrine sales increased primarily due to an increase in unit volumes, as a result of supplier shortages Lidocaine sales increased primarily due to higher unit volumes as supply chain issues eased allowing us to fulfill backorders Primatene MIST® sales increased $1.3 million due to an increase in unit volumes, with the remainder of the increase due to an increase in average selling price Enoxaparin and naloxone sales decreased primarily due to a decrease in unit volumes Other finished pharmaceutical product sales increased primarily due to: Higher unit volumes of atropine, calcium chloride, and sodium bicarbonate, due to increased demand caused by supplier shortages during the fourth quarter Launch of regadenoson in April 2023 Active Pharmaceutical Ingredient ("API") sales increased primarily due to the timing of customer purchases Other revenues are comprised of net revenues from the sales of BAQSIMI® of $22.5 million during the three months ended December 31, 2023, which was recognized on a net basis similar to a royalty arrangement and based on Eli Lilly & Company's ("Lilly") reported BAQSIMI® net sales of $37.6 million. Currently, BAQSIMI® is being sold by Lilly on our behalf under the Transition Services Agreement ("TSA") with Lilly, whereby Lilly provides certain services to support the transition of the BAQSIMI® operations to us. Once Amphastar takes over the distribution of BAQSIMI®, Amphastar will recognize the entire revenue amount. This revenue recognition change is expected to be phased in by country during 2024. Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Net revenues $ 178,105 $ 135,023 $ 43,082 32 % Cost of revenues 81,965 63,855 18,110 28 % Gross profit $ 96,140 $ 71,168 $ 24,972 35 % as % of net revenues 54 % 53 % Changes in the cost of revenues and gross margin were primarily driven by: Increased sales of higher-margin products such as glucagon and Primatene MIST®, as well as the sales of regadenoson, which we launched in April 2023. As a result of the TSA, the revenue relating to BAQSIMI® is recognized on a net basis within net revenues. These factors were partially offset by charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value, which includes a $3.6 million inventory reserve as a result of amending the Supply Agreement with MannKind Corporation in December 2023. Three Months Ended December 31, Change 2023 2022 Dollars % (in thousands) Selling, distribution, and marketing $ 8,619 $ 5,472 $ 3,147 58 % General and administrative 13,122 10,628 2,494 23 % Research and development 20,419 17,236 3,183 18 % Non-operating (expenses) income, net (12,635 ) 3,428 (16,063 ) NM Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®. General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI®, which was partially offset by a decrease in legal fees. Research and development expenses increased due to an increase in materials and supply expenses, primarily related to our inhalation pipeline products. The change in non-operating (expenses) income, net is primarily a result of: Interest expense in the fourth quarter of 2023, which was primarily related to our Wells Fargo Bank syndicated loan, as well as our convertible debt Foreign currency fluctuations Mark-to-market adjustments relating to our interest rate swap contracts. Year-End Results Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Product revenues: Glucagon $ 113,684 $ 55,322 $ 58,362 105 % Primatene MIST® 89,321 84,309 5,012 6 % Epinephrine 81,650 74,204 7,446 10 % Lidocaine 58,162 52,539 5,623 11 % Phytonadione 44,939 49,500 (4,561 ) (9 )% Enoxaparin 31,533 34,950 (3,417 ) (10 )% Naloxone 19,004 26,269 (7,265 ) (28 )% Other finished pharmaceutical products 140,823 109,412 31,411 29 % Total finished pharmaceutical products net revenues $ 579,116 $ 486,505 $ 92,611 19 % API 14,122 12,482 1,640 13 % Other revenues 51,157 - 51,157 N/A Total product revenues, net $ 644,395 $ 498,987 $ 145,408 29 % Changes in product revenues were primarily driven by: Glucagon sales increased primarily due to an increase in unit volumes as a result of two competitors discontinuing their glucagon injection products at the end of 2022 Primatene MIST® sales increased due to an increase in the average selling price Epinephrine and lidocaine sales increased primarily due to an increase in unit volumes as a result of supplier shortages Phytonadione sales decreased due to lower unit volumes as a result of increased competition Enoxaparin sales decreased primarily due to a decrease in unit volumes Sales of naloxone decreased due to lower unit volumes, reducing sales by $4.6 million, as well as a lower average selling price, reducing sales by $2.7 million as a result of increased competition Other finished pharmaceutical product sales increased primarily due to: Higher unit volumes of dextrose, atropine, calcium chloride, and sodium bicarbonate due to increased demand caused by supplier shortages during the year A full year of sales for ganirelix and vasopressin, which was launched in June 2022 and August 2022, respectively Launch of regadenoson in April 2023 API sales increased primarily due to the timing of customer purchases Other revenues are comprised of net revenues from the sales of BAQSIMI® of $51.2 million during the year ended December 31, 2023, which was recognized on a net basis similar to a royalty and based on Lilly's reported BAQSIMI® net sales of $86.3 million. Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Net revenues $ 644,395 $ 498,987 $ 145,408 29 % Cost of revenues 293,274 250,127 43,147 17 % Gross profit $ 351,121 $ 248,860 $ 102,261 41 % as % of net revenues 54 % 50 % Changes in the cost of revenues and gross margin were primarily driven by: Increased sales of higher-margin products such as glucagon and Primatene MIST®, the sales of ganirelix and vasopressin that were launched in 2022, as well as the sales of regadenoson, which we launched in April 2023 As a result of the TSA, the revenue relating to BAQSIMI® is recognized on a net basis within net revenues. These factors were partially offset by an impairment charge of $2.7 million related to the impairment of the IMS (UK) international product rights, as well as charges included in cost of revenues to adjust our inventory and related purchase commitments to their net realizable value, which includes a $3.6 million inventory reserve as a result of amending the Supply Agreement with MannKind Corporation in December 2023 Year Ended December 31, Change 2023 2022 Dollars % (in thousands) Selling, distribution, and marketing $ 28,853 $ 21,531 $ 7,322 34 % General and administrative 51,540 45,061 6,479 14 % Research and development 73,741 74,771 (1,030 ) (1 )% Non-operating (expenses) income, net (25,628 ) 8,543 (34,171 ) NM Selling, distribution, and marketing expenses increased primarily due to expenses related to the expansion of our sales and marketing efforts related to BAQSIMI®, as well as an increase in advertising spending for Primatene MIST® General and administrative expenses increased primarily due to an increase in salary and personnel-related expenses, as well as costs related to the acquisition of BAQSIMI®, which was partially offset by a decrease in legal fees Research and development expenses decreased due to: Decreases in materials and supply expenses as a result of a ramp-up of expenses in 2022 for AMP-018 and our insulin pipeline products This decrease was partially offset by an increase in salary and personnel-related expenses The change in non-operating (expenses) income, net is primarily a result of: Foreign currency fluctuations Costs incurred in connection with the syndicated credit agreement we entered into with Wells Fargo Bank, as syndication agent, to finance the acquisition of BAQSIMI® Mark-to-market adjustments relating to our interest rate swap contracts Cash flow provided by operating activities for the year ended December 31, 2023 was $183.5 million. Pipeline Information The Company currently has four abbreviated new drug applications ("ANDAs") and one biosimilar insulin candidate on the U.S. Food and Drug Administration (the "FDA") targeting products with a market size of over $3 billion and $4 billion, respectively, three biosimilar products in development targeting products with a market size of over $10 billion, and six generic products in development targeting products with a market size of over $8 billion. This market information is based on IQVIA data for the 12 months ended December 31, 2023. The Company is developing multiple proprietary products with injectable and intranasal dosage forms. Amphastar's Chinese subsidiary, Amphastar Nanjing Pharmaceuticals, Co., Ltd. ("ANP"), currently has multiple Drug Master Files ("DMFs"), on the FDA and is developing several additional DMFs. Company Information Amphastar is a bio-pharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling technically-challenging generic and proprietary injectable, inhalation, and intranasal products. Additionally, the Company sells insulin API products. Most of the Company's finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. More information and resources are available at . Amphastar's logo and other trademarks or service marks of Amphastar, including, but not limited to Amphastar®, BAQSIMI®, Primatene MIST®, REXTOVYTM, Amphadase®, and Cortrosyn®, are the property of Amphastar. Non-GAAP Financial Measures To supplement its consolidated financial statements, which are prepared and presented in accordance with U.S. generally accepted accounting principles ("GAAP"), the Company is disclosing non-GAAP financial measures when providing financial results. The Company believes that an evaluation of its ongoing operations (and comparisons of its current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with GAAP. As a result, the Company is disclosing certain non-GAAP results, including (i) Adjusted non-GAAP net income (loss) and (ii) Adjusted non-GAAP diluted EPS, which exclude amortization expense, share-based compensation, impairment charges, expenses related to our acquisition of BAQSIMI®, debt issuance costs, legal settlements, and other one-time events in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance because the Company's management uses these measures internally for forecasting, budgeting, and measuring its operating performance. Whenever the Company uses such non-GAAP measures, it will provide a reconciliation of non-GAAP financial measures to their most directly comparable GAAP financial measures. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most directly comparable GAAP measures set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. Conference Call Information The Company will hold a conference call to discuss its financial results today, February 28, 2024, at 2:00 p.m. Pacific Time. To access the conference call, dial toll-free (877) 407-0989 or (201) 389-0921 for international callers, ten minutes before the conference. The call can also be accessed on the Investors page on the Company's website at . Forward-Looking Statements All statements in this press release and in the conference call referenced above that are not historical are forward-looking statements, including, among other things, statements relating to our expectations regarding future financial performance and business trends, our future growth, sales and marketing of our products, market size and expansion, product portfolio, product development, the timing of FDA filings or approvals, including the DMFs of ANP, the timing of product launches, acquisitions and other matters related to our pipeline of product candidates, the timing and results of clinical trials, the prospective benefits of the acquisition of BAQSIMI®, and other future events. These statements are not facts but rather are based on Amphastar's historical performance and our current expectations, estimates, and projections regarding our business, operations, and other similar or related factors. Words such as "may," "might," "will," "could," "would," "should," "anticipate," "predict," "potential," "continue," "expect," "intend," "plan," "project," "believe," "estimate," and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond Amphastar's control. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including those described in Amphastar's filings with the Securities and Exchange Commission, including in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 1, 2023, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 9, 2023, in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 8, 2023, and in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2023, filed with the SEC on November 8, 2023. In particular, there can be no guarantee that the acquisition of BAQSIMI® will be beneficial to our business, that any event, change or other circumstance could cause the results of the acquisition and integration of BAQSIMI® into our product portfolio to differ from Amphastar's expectation, that all or any of the contingent consideration will be payable on the terms described herein or at all, or that Amphastar can reliably predict the impact of BAQSIMI® on its financial results or financial guidance. You can locate these reports through our website at and on the SEC's website at . The forward-looking statements in this release speak only as of the date of the release. Amphastar undertakes no obligation to revise or update information or any forward-looking statements in this press release or the conference call referenced above to reflect events or circumstances in the future, even if new information becomes available or if subsequent events cause our expectations to change. Contact Information: Amphastar Pharmaceuticals, Inc. Bill Peters Chief Financial Officer (909) 476-3416 Table I Amphastar Pharmaceuticals, Inc. Condensed Consolidated Statement of Operations (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 Net revenues: Product revenues, net $ 155,649 $ 135,023 $ 593,238 $ 498,987 Other revenues 22,456 - 51,157 - Total net revenues 178,105 135,023 644,395 498,987 Cost of revenues 81,965 63,855 293,274 250,127 Gross profit 96,140 71,168 351,121 248,860 Operating expenses: Selling, distribution, and marketing 8,619 5,472 28,853 21,531 General and administrative 13,122 10,628 51,540 45,061 Research and development 20,419 17,236 73,741 74,771 Total operating expenses 42,160 33,336 154,134 141,363 Income from operations 53,980 37,832 196,987 107,497 Non-operating (expenses) income, net (12,635 ) 3,428 (25,628 ) 8,543 Income before income taxes 41,345 41,260 171,359 116,040 Income tax provision 4,673 7,290 31,833 23,477 Net income before equity in losses of unconsolidated affiliate 36,672 33,970 139,526 92,563 Equity in losses of unconsolidated affiliate (505 ) (57 ) (1,981 ) (1,177 ) Net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Net income per share: Basic $ 0.75 $ 0.70 $ 2.85 $ 1.88 Diluted $ 0.68 $ 0.66 $ 2.60 $ 1.74 Weighted-average shares used to compute net income per share: Basic 47,957 48,298 48,265 48,551 Diluted 53,014 51,716 53,001 52,427 Table II Amphastar Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (Unaudited; in thousands, except share data) December 31, December 31, 2023 2022 ASSETS Current assets: Cash and cash equivalents $ 144,296 $ 156,098 Restricted cash 235 235 Short-term investments 112,510 19,664 Restricted short-term investments 2,200 2,200 Accounts receivable, net 114,943 88,804 Inventories 105,833 103,584 Income tax refunds and deposits 526 171 Prepaid expenses and other assets 9,057 7,563 Total current assets 489,600 378,319 Property, plant, and equipment, net 282,746 238,266 Finance lease right-of-use assets 564 753 Operating lease right-of-use assets 32,333 25,554 Investment in unconsolidated affiliate 527 2,414 Goodwill and intangible assets, net 613,295 37,298 Long-term investments 14,685 - Other assets 25,910 20,856 Deferred tax assets 53,252 38,527 Total assets $ 1,512,912 $ 741,987 LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable and accrued liabilities $ 93,366 $ 84,242 Accrued payments for BAQSIMI® 126,090 - Income taxes payable 1,609 4,571 Current portion of long-term debt 436 3,046 Current portion of operating lease liabilities 3,906 3,003 Total current liabilities 225,407 94,862 Long-term reserve for income tax liabilities 6,066 7,225 Long-term debt, net of current portion and unamortized debt issuance costs 589,579 72,839 Long-term operating lease liabilities, net of current portion 29,721 23,694 Deferred tax liabilities - 144 Other long-term liabilities 22,718 14,565 Total liabilities 873,491 213,329 Commitments and contingencies Stockholders' equity: Preferred stock: par value $0.0001; 20,000,000 shares authorized; no shares issued and outstanding - - Common stock: par value $0.0001; 300,000,000 shares authorized; 59,390,194 and 48,068,881 shares issued and outstanding as of December 31, 2023 and 58,110,231 and 48,112,069 shares issued and outstanding as of December 31, 2022, respectively 6 6 Additional paid-in capital 486,056 455,077 Retained earnings 409,268 271,723 Accumulated other comprehensive loss (8,478 ) (8,624 ) Treasury stock (247,431 ) (189,524 ) Total equity 639,421 528,658 Total liabilities and stockholders' equity $ 1,512,912 $ 741,987 Table III Amphastar Pharmaceuticals, Inc. Reconciliation of Non-GAAP Measures (Unaudited; in thousands, except per share data) Three Months Ended Year Ended December 31, December 31, 2023 2022 2023 2022 GAAP net income $ 36,167 $ 33,913 $ 137,545 $ 91,386 Adjusted for: Intangible amortization 6,178 331 12,830 1,419 Share-based compensation 4,622 4,304 20,242 17,860 Impairment of long-lived assets 1 - 3,175 - Expenses related to BAQSIMI® acquisition 2,148 - 5,830 - Debt issuance costs 742 - 6,785 - Litigation settlements - - - (4,929 ) Income tax provision on pre-tax adjustments (2,983 ) (910 ) (10,708 ) (2,550 ) Non-GAAP net income $ 46,875 $ 37,638 $ 175,699 $ 103,186 Non-GAAP net income per share: Basic $ 0.98 $ 0.78 $ 3.64 $ 2.13 Diluted $ 0.88 $ 0.73 $ 3.32 $ 1.97 Weighted-average shares used to compute non-GAAP net income per share: Basic 47,957 48,298 48,265 48,551 Diluted 53,014 51,716 53,001 52,427 Three Months Ended December 31, 2023 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 81,965 $ 8,619 $ 13,122 $ 20,419 $ (12,635 ) $ 4,673 Intangible amortization (6,158 ) - (3 ) (17 ) - - Share-based compensation (1,023 ) (221 ) (2,946 ) (432 ) - - Impairment of long-lived assets - - (1 ) - - - Expenses related to BAQSIMI® acquisition - - (322 ) - 1,826 - Debt issuance costs - - - - 742 - Income tax provision on pre-tax adjustments - - - - - 2,983 Non-GAAP $ 74,784 $ 8,398 $ 9,850 $ 19,970 $ (10,067 ) $ 7,656 Three Months Ended December 31, 2022 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 63,855 $ 5,472 $ 10,628 $ 17,236 $ 3,428 $ 7,290 Intangible amortization (205 ) - (126 ) - - - Share-based compensation (941 ) (186 ) (2,791 ) (386 ) - - Income tax provision on pre-tax adjustments - - - - - 910 Non-GAAP $ 62,709 $ 5,286 $ 7,711 $ 16,850 $ 3,428 $ 8,200 Year Ended December 31, 2023 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 293,274 $ 28,853 $ 51,540 $ 73,741 $ (25,628 ) $ 31,833 Intangible amortization (12,741 ) - (19 ) (70 ) - - Share-based compensation (4,891 ) (870 ) (12,269 ) (2,212 ) - - Impairment of long-lived assets (3,170 ) - (5 ) - - - Expenses related to BAQSIMI® acquisition - - (2,179 ) - 3,651 - Debt issuance costs - - - - 6,785 - Income tax provision on pre-tax adjustments - - - - - 10,708 Non-GAAP $ 272,472 $ 27,983 $ 37,068 $ 71,459 $ (15,192 ) $ 42,541 Year Ended December 31, 2022 Cost of revenue Selling, distribution and marketing General and administrative Research and development Non-operating (expenses) income, net Income tax provision GAAP $ 250,127 $ 21,531 $ 45,061 $ 74,771 $ 8,543 $ 23,477 Intangible amortization (865 ) - (554 ) - - - Share-based compensation (4,179 ) (726 ) (11,180 ) (1,775 ) - - Litigation settlements - - (800 ) - (5,729 ) - Income tax provision on pre-tax adjustments - - - - - 2,550 Non-GAAP $ 245,083 $ 20,805 $ 32,527 $ 72,996 $ 2,814 $ 26,027 SOURCE: Amphastar Pharmaceuticals, Inc. 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Financial consideration is the most important factor why foreign pharmas outsource commercialization in China. Big Pharma companies have often talked about the major opportunities that await in China. But as price cuts play out and internal priorities shift, multinational companies are reworking their business models in the country. In the last few months of 2023, Pfizer, GSK, Sanofi and Biogen have each tapped local partners to help commercialize their products in China. With marketing responsibilities shifting to other firms, job cuts were expected at each of those large drugmakers. It’s not a new approach for foreign drugmakers to tap local partners in China, Justin Wang, head of L.E.K. Consulting’s China practice, pointed out in an email interview with Fierce Pharma. But these deals are on the rise lately, Wang explained, partly because “there is increasing pricing and competitive pressure in the market, especially for mature products, leaving reduced [return on investment] for in-house commercial resources.” Pfizer in November unveiled a deal with Keyuan Pharma, granting the Shanghai Pharma subsidiary exclusive rights to distribute and promote its pneumococcal vaccine Prevenar 13 (known as Prevnar 13 in the U.S.) in China. “We believe that this partnership will leverage the synergies of both companies and make Prevenar 13 available to a much broader population in China,” a Pfizer spokesperson told Fierce Pharma. Pfizer’s announcement came about a month after GSK signed on Chongqing Zhifei Biological Products to distribute its shingles vaccine, Shingrix, in China. Zhifei made a name as the marketer of Merck’s HPV shot Gardasil in China. Thanks to Gardasil’s impressive growth in the country, Merck earlier this year surpassed AstraZeneca as China’s largest foreign pharma company by sales. Before AZ, that title belonged to Pfizer. Local companies have strong track records from prior Big Pharma partnerships, Wang noted, so that’s another reason why the deals are gaining in popularity in recent months. With the two new collaborations, three of the world’s top-selling vaccines are now all handled by local firms in China. The vaccine commercialization model is different in China than in the U.S. As local Chinese CDC agencies serve as direct customers of the immunizations, vaccines have no commercial synergies with other drugs, Wang explained. Chinese regulators divide vaccines into two types: mandatory and voluntary. Gardasil, Prevnar and Shingrix all belong to the Class 2 voluntary group. The Class 2 vaccines require heavy investment and intensive market education, which can be burdensome for foreign pharma companies. Zhifei, for example, has assembled a commercial team of more than 3,000 people, he noted. Pfizer’s existing Prevenar China team—reportedly 400 people strong—is being disbanded, according to local reports. Pfizer’s spokesperson declined to comment on the number of jobs affected by the Keyuan deal. The move comes as Pfizer cuts costs around the globe to save $4 billion annually by the end of 2024 in response to declining COVID product sales. The company’s spokesperson said the Keyuan partnership is “independent of any other company initiative or business decision.”   It’s not just vaccines At GSK, it appears the company is further restructuring its China business beyond the Shingrix pact. According to local reports from a few days ago, the British drugmaker is outsourcing commercialization of two older meds, the COPD inhaler Anoro and the anti-epileptic Lamictal. Sales staffers supporting those drugs are also expected to be let go, according to the reports. GSK declined to comment on this subject. Beyond Pfizer and GSK, Biogen has established a strategic partnership with a local company for its multiple sclerosis portfolio in China, a company spokesperson confirmed with Fierce Pharma. Biogen sells MS drugs Fampyra and Tecfidera in the country. Similar to Pfizer, Biogen is also undergoing a companywide cost-cutting initiative, which aims to reduce its workforce by 1,000 and save $1 billion in operating expenses by 2025. Almost simultaneous to the Biogen accord, Sanofi China unveiled a “broad and deep” collaboration with Shanghai Pharma. The two companies will partner on treatments for cardiovascular diseases, central nervous system disorders and cancer so that Sanofi can build a business model that “better fits the local market and optimizes operations,” the French pharma said in a Dec. 14 release published on its official WeChat account. Sanofi wouldn’t comment on the exact products involved. Local reports said the company is delegating marketing responsibilities around MS drug Aubagio, the thrombosis med Clexane (also known as Lovenox), anti-serum phosphorus therapy Renvela, as well as chemotherapies oxaliplatin and docetaxel. “To support the execution of our strategy, we are looking at adjusting our organization setup and optimizing our commercial presence, identifying partners capable of ensuring the sustainable distribution of our portfolio of medicines for patients,” a Sanofi spokesperson told Fierce Pharma. As part of its third-quarter earnings, Sanofi launched an initiative to save up to 2 billion euros from 2024 to the end of 2025. The company’s recent corporate update led to a rare, 20% price drop in Sanofi’s stock. In striking the deals, both Sanofi and Biogen have opted not to pursue selling MS meds on their own in the country. That’s despite Biogen winning national coverage for Tecfidera.   MS is a rare disease in China with a very low diagnosis rate, making it a tough market, L.E.K.’s Wang noted. “Rare disease drugs are not easy for any pharma to manage in China,” Wang said. “You need to establish the diagnosis and treatment protocols and referral networks to find the right patients.”   Commercial trade-offs Meanwhile, China’s National Reimbursement Drug List (NRDL) poses a sticking point for some products because it does not allow the high prices for rare disease medicines that are seen in the U.S. Therefore, market access remains a challenge for medicines with high prices, Wang added. The NRDL represents a trade-off between sharp discounts and a large patient base, and calculations around revenue, profitability and commercial investment determine whether a drug is better off staying outside of the program, Wang said. Even after winning national coverage, drugs aren’t guaranteed commercial success under NRDL. While national insurance opens up broader market access, “you still need efforts to be listed in each hospital’s formulary, educate physicians, and ensure reimbursement implementation in local jurisdictions,” Wang noted. Therefore, a company typically needs to ramp up marketing investment to be able to reap the benefits of NRDL.   Lately, many Western pharma companies have decided not to pursue NRDL coverage for some of their drugs. None of the major PD-1/L1 inhibitors are currently on the NRDL, and foreign pharmas’ antibody-drug conjugates (ADCs), including AZ and Daiichi Sankyo’s Enhertu and Gilead Sciences’ Trodelvy, also didn’t make the cut. Besides the NRDL, China’s volume-based procurement (VBP) program is designed to cut prices for older off-patent meds. Foreign pharmas have formed several local partnerships for mature products that need deeper “coverage” than market education, Wang noted. These deals also depend on the pharma company’s interest to explore “lower-tier” markets outside the major cities, he said.   Various forms of engagement Financial trade-offs appear to be the most important factor accelerating the trend of Big Pharma companies reducing their marketing responsibilities in China, Wang said. But geopolitical risk is “certainly something influencing decision-making—especially at the HQs.” The volatile political environment means some smaller drugmakers may be hesitant to go big on China, but large pharmas are still committed to investing in China in various forms, Wang noted. For example, as part of GSK’s reshuffling in China, the company set a goal to become a top 10 foreign pharma in China by 2030. The U.K. drugmaker recently also in-licensed two ADCs from Chinese biotech Hansoh Pharmaceutical. “You can find molecules in China and [often] the Chinese companies just want the [domestic] rights so you can negotiate … [to] take it globally,” GSK’s chief commercial officer, Luke Miels, recently told The Financial Times “A key theme we see is that [Big Pharma companies] are actively optimizing their commercial models,” L.E.K.’s Wang observes, “on the one hand exploring various forms of partnerships to access external resources, and on the other hand increasing in-house team efficiencies through new digital/omnichannel customer engagement models.”