| | |
IMPORTANT NOTICE REGARDING THE AVAILABILITY OF PROXY MATERIALS FOR THE SPECIAL MEETING TO BE HELD ON MARCH 11, 2025:
THIS NOTICE OF SPECIAL MEETING, PROXY STATEMENT AND PROXY CARD ARE AVAILABLE AT https://investors.coherus.com.
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| | ||||
| | | | | By order of the Board of Directors | |
| | Dated: January 28, 2025 | | | | |
| | Redwood City, California | | |
/s/ Bryan McMichael
Bryan McMichael
Chief Financial Officer |
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| | | | | | F-1 | | | |
| | ANNEX A | | | |||||
| | | | | | A-1 | | | |
| | ANNEX B | | | |||||
| | | | | | B-1 | | | |
|
Announcement Date
|
| |
Acquiror
|
| |
Target
|
|
| June 23, 2022 | | |
Patient Square Capital/Gurnet Point Capital
|
| | Radius Health, Inc. | |
| April 13, 2022 | | | Halozyme Therapeutics, Inc. | | | Antares Pharma, Inc. | |
|
October 11, 2021
|
| | Pacira Biosciences, Inc. | | | Flexion Therapeutics, Inc. | |
|
October 11, 2021
|
| | Supernus Pharmaceuticals, Inc. | | |
Adamas Pharmaceuticals, Inc.
|
|
|
October 1, 2020
|
| | Covis Group S.à r.l. | | |
AMAG Pharmaceuticals, Inc.
|
|
|
UDENYCA (in millions)
|
| |
2024
TOTAL |
| |
2025
TOTAL |
| |
2026
TOTAL |
| |
2027
TOTAL |
| |
2028
TOTAL |
| |
2029
TOTAL |
| ||||||||||||||||||
|
Revenue
|
| | | | 219.8 | | | | | | 347.7 | | | | | | 343.4 | | | | | | 334.2 | | | | | | 326.4 | | | | | | 320.0 | | |
|
COGS & Royalties
|
| | | | (84.2) | | | | | | (101.6) | | | | | | (94.7) | | | | | | (91.2) | | | | | | (90.8) | | | | | | (90.4) | | |
|
Expenses
|
| | | | (49.2) | | | | | | (44.9) | | | | | | (43.6) | | | | | | (43.2) | | | | | | (43.1) | | | | | | (43.1) | | |
|
Net Profit
|
| | | $ | 86.3 | | | | | $ | 201.3 | | | | | $ | 205.1 | | | | | $ | 199.8 | | | | | $ | 192.5 | | | | | $ | 186.4 | | |
|
UDENYCA (in millions)
|
| |
2024
TOTAL |
| |
2025
TOTAL |
| |
2026
TOTAL |
| |
2027
TOTAL |
| |
2028
TOTAL |
| |
2029
TOTAL |
| ||||||||||||||||||
|
Revenue
|
| | | | 219.8 | | | | | | 365.7 | | | | | | 395.2 | | | | | | 410.5 | | | | | | 395.2 | | | | | | 387.4 | | |
|
COGS & Royalties
|
| | | | (81.4) | | | | | | (92.3) | | | | | | (93.5) | | | | | | (96.5) | | | | | | (95.6) | | | | | | (95.6) | | |
|
Expenses
|
| | | | (49.2) | | | | | | (44.9) | | | | | | (43.6) | | | | | | (43.2) | | | | | | (43.1) | | | | | | (43.1) | | |
|
Net Profit
|
| | | $ | 89.1 | | | | | $ | 228.6 | | | | | $ | 258.1 | | | | | $ | 270.8 | | | | | $ | 256.5 | | | | | $ | 248.7 | | |
|
UDENYCA (in millions)
|
| |
2024
TOTAL |
| |
2025
TOTAL |
| |
2026
TOTAL |
| |
2027
TOTAL |
| |
2028
TOTAL |
| |
2029
TOTAL |
| ||||||||||||||||||
|
Revenue
|
| | | | 190.2 | | | | | | 247.4 | | | | | | 352.0 | | | | | | 340.5 | | | | | | 326.4 | | | | | | 320.0 | | |
|
COGS & Royalties
|
| | | | (70.7) | | | | | | (93.5) | | | | | | (102.7) | | | | | | (90.0) | | | | | | (88.0) | | | | | | (88.0) | | |
|
Expenses
|
| | | | (55.1) | | | | | | (47.0) | | | | | | (44.8) | | | | | | (44.4) | | | | | | (44.3) | | | | | | (44.3) | | |
|
Net Profit
|
| | | $ | 64.5 | | | | | $ | 106.9 | | | | | $ | 204.5 | | | | | $ | 206.2 | | | | | $ | 194.1 | | | | | $ | 187.7 | | |
|
Name and, as appropriate, Address of Beneficial Owner
|
| |
Number of
Outstanding Shares of Common Stock Beneficially Owned |
| |
Number of
Shares Convertible/ Exercisable Within 60 Days |
| |
Number of
Shares of Common Stock Beneficially Owned |
| |
Percentage of
Common Stock Beneficially Owned |
| ||||||||||||
| 5% Security Holders: | | | | | | | | | | | | | | | | | | | | | | | | | |
| BlackRock, Inc.(1) | | | | | 12,074,695 | | | | | | | | | | | | 12,074,695 | | | | | | 10.42% | | |
|
The Vanguard Group, Inc.(2)
|
| | | | 10,357,412 | | | | | | | | | | | | 10,357,412 | | | | | | 8.94% | | |
|
Rubric Capital Management LP(3)
|
| | | | 10,400,000 | | | | | | | | | | | | 10,400,000 | | | | | | 8.97% | | |
| Named Executive Officers and Directors: | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Ali J. Satvat(4)
|
| | | | 3,036,576 | | | | | | 110,000 | | | | | | 3,146,576 | | | | | | 2.71% | | |
|
Dennis M. Lanfear(5)
|
| | | | 1,204,723 | | | | | | 3,947,262 | | | | | | 5,151,985 | | | | | | 4.30% | | |
|
Lee N. Newcomer, MD(6)
|
| | | | — | | | | | | 92,250 | | | | | | 92,250 | | | | | | *% | | |
|
Mats L. Wahlström(7)
|
| | | | 99,988 | | | | | | 270,250 | | | | | | 370,238 | | | | | | *% | | |
|
Charles W. Newton(8)
|
| | | | — | | | | | | 89,250 | | | | | | 89,250 | | | | | | *% | | |
|
Rita A. Karachun(9)
|
| | | | — | | | | | | — | | | | | | — | | | | | | —% | | |
|
Bryan McMichael(10)
|
| | | | 22,951 | | | | | | 204,581 | | | | | | 227,532 | | | | | | *% | | |
|
Jill O’Donnell-Tormey, Ph.D.(11)
|
| | | | — | | | | | | 89,250 | | | | | | 89,250 | | | | | | *% | | |
|
Mark D. Stolper(12)
|
| | | | 8,800 | | | | | | 125,250 | | | | | | 134,050 | | | | | | *% | | |
|
Michael Ryan(13)
|
| | | | — | | | | | | 30,000 | | | | | | 30,000 | | | | | | *% | | |
|
Georgia Erbez(14)
|
| | | | — | | | | | | 19,500 | | | | | | 19,500 | | | | | | *% | | |
|
Paul Reider(15)
|
| | | | 82,069 | | | | | | 352,186 | | | | | | 434,255 | | | | | | *% | | |
|
McDavid Stilwell(16)
|
| | | | 75,305 | | | | | | — | | | | | | 75,305 | | | | | | *% | | |
|
Vladimir Vexler, Ph.D.(17)
|
| | | | 76,362 | | | | | | — | | | | | | 76,362 | | | | | | *% | | |
|
All directors and executive officers as a group (12 persons)(18)
|
| | | | 4,455,107 | | | | | | 5,329,779 | | | | | | 9,784,886 | | | | | | 8.07% | | |
| | | | | By order of the Board of Directors | |
| | Dated: January 28, 2025 | | |
/s/ Bryan McMichael
Bryan McMichael
Chief Financial Officer |
|
| | | | | | | | | |
Transaction
|
| | | | | | | | | | |||||||||
| | | |
Historical
Coherus |
| |
Transaction (3a)
|
| |
UDENYCA
Transaction Accounting Adjustments |
| |
Notes
|
| |
Combined
Balance Sheet |
| ||||||||||||
| Assets | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Cash and cash equivalents
|
| | | $ | 97,690 | | | | | $ | — | | | | | $ | 466,315 | | | |
3b
|
| | | $ | 276,223 | | |
| | | | | | | | | | | | — | | | | | | (235,391) | | | |
3c
|
| | | | | | |
| | | | | | | | | | | | — | | | | | | (52,391) | | | |
3d
|
| | | | | | |
|
Trade receivables, net
|
| | | | 167,559 | | | | | | — | | | | | | — | | | | | | | | | 167,559 | | |
|
TSA receivables, net
|
| | | | 31,241 | | | | | | — | | | | | | — | | | | | | | | | 31,241 | | |
|
Inventory
|
| | | | 47,640 | | | | | | (45,506) | | | | | | — | | | | | | | | | 2,134 | | |
|
Prepaid manufacturing
|
| | | | 10,718 | | | | | | (5,040) | | | | | | — | | | | | | | | | 5,678 | | |
|
Other prepaids and current assets
|
| | | | 14,176 | | | | | | (1,779) | | | | | | — | | | | | | | | | 12,397 | | |
|
Total current assets
|
| | | | 369,024 | | | | | | (52,325) | | | | | | 178,533 | | | | | | | | | 495,232 | | |
|
Property and equipment, net
|
| | | | 2,911 | | | | | | (14) | | | | | | — | | | | | | | | | 2,897 | | |
|
Inventory, non-current
|
| | | | 71,375 | | | | | | (71,375) | | | | | | — | | | | | | | | | — | | |
|
Intangible assets, net
|
| | | | 54,313 | | | | | | — | | | | | | — | | | | | | | | | 54,313 | | |
|
Other assets, non-current
|
| | | | 7,377 | | | | | | (241) | | | | | | — | | | | | | | | | 7,136 | | |
|
Total assets
|
| | | $ | 505,000 | | | | | $ | (123,955) | | | | | $ | 178,533 | | | | | | | | $ | 559,578 | | |
| Liabilities and stockholders’ deficit | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Accounts payable
|
| | | $ | 21,893 | | | | | $ | — | | | | | $ | — | | | | | | | | $ | 21,893 | | |
|
Accrued rebates, fees and reserves
|
| | | | 163,315 | | | | | | — | | | | | | — | | | | | | | | | 163,315 | | |
|
TSA payables and other accrued liabilities
|
| | | | 33,637 | | | | | | — | | | | | | — | | | | | | | | | 33,637 | | |
|
Accrued compensation
|
| | | | 15,756 | | | | | | — | | | | | | — | | | | | | | | | 15,756 | | |
|
Accrued and other current liabilities
|
| | | | 60,965 | | | | | | — | | | | | | (281) | | | |
3b
|
| | | | 48,951 | | |
| | | | | | | | | | | | — | | | | | | (1,591) | | | |
3c
|
| | | | | | |
| | | | | | | | | | | | — | | | | | | (10,142) | | | |
3d
|
| | | | | | |
|
Total current liabilities
|
| | | | 295,566 | | | | | | — | | | | | | (12,014) | | | | | | | | | 283,552 | | |
|
Term loans
|
| | | | 36,618 | | | | | | — | | | | | | — | | | | | | | | | 36,618 | | |
|
Convertible notes
|
| | | | 227,891 | | | | | | — | | | | | | (227,891) | | | |
3c
|
| | | | — | | |
|
Lease liabilities, non-current
|
| | | | 3,737 | | | | | | — | | | | | | — | | | | | | | | | 3,737 | | |
|
Other liabilities, non-current
|
| | | | 29,161 | | | | | | — | | | | | | (16,120) | | | |
3d
|
| | | | 13,041 | | |
|
Total liabilities
|
| | | | 592,973 | | | | | | — | | | | | | (256,025) | | | | | | | | | 336,948 | | |
|
Commitments and contingencies
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
| Stockholders’ deficit: | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Preferred stock ($0.0001 par value; shares authorized: 5,000,000; shares issued and outstanding: 0)
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | — | | |
|
Common stock ($0.0001 par value; shares authorized: 300,000,000; shares issued and outstanding: 115,213,407)
|
| | | | 12 | | | | | | — | | | | | | — | | | | | | | | | 12 | | |
|
Additional paid-in capital
|
| | | | 1,412,587 | | | | | | — | | | | | | 655 | | | |
3e
|
| | | | 1,413,242 | | |
|
Accumulated other comprehensive loss
|
| | | | (275) | | | | | | — | | | | | | — | | | | | | | | | (275) | | |
|
Accumulated deficit
|
| | | | (1,500,297) | | | | | | (123,955) | | | | | | 466,596 | | | |
3b
|
| | | | (1,190,349) | | |
| | | | | | | | | | | | — | | | | | | (5,909) | | | |
3c
|
| | | | | | |
| | | | | | | | | | | | — | | | | | | (26,129) | | | |
3d
|
| | | | | | |
| | | | | | | | | | | | — | | | | | | (655) | | | |
3e
|
| | | | | | |
|
Total stockholders’ deficit
|
| | | | (87,973) | | | | | | (123,955) | | | | | | 434,558 | | | | | | | | | 222,630 | | |
|
Total liabilities and stockholders’ deficit
|
| | | $ | 505,000 | | | | | $ | (123,955) | | | | | $ | 178,533 | | | | | | | | $ | 559,578 | | |
| | | | | | | | | |
CIMERLI Disposition
|
| | | | | | | | | | | | | |
Transaction
|
| | | | | | | ||||||||||||||||||
| | | |
Historical
Coherus |
| |
CIMERLI
Disposition (4f) |
| |
CIMERLI
Transaction Accounting Adjustment (4g) |
| |
YUSIMRY
Disposition (4h) |
| |
Subtotal
adjusted for historical transactions |
| |
Transaction (4i)
|
| |
UDENYCA
Transaction Accounting Adjustment (4j) |
| |
Combined
Statements of Operations |
| ||||||||||||||||||||||||
|
Net revenue
|
| | | $ | 212,816 | | | | | $ | (26,979) | | | | | $ | — | | | | | $ | (7,508) | | | | | $ | 178,329 | | | | | $ | (159,673) | | | | | $ | — | | | | | $ | 18,656 | | |
| Costs and expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 83,695 | | | | | | (16,877) | | | | | | — | | | | | | (7,619) | | | | | | 59,199 | | | | | | (53,222) | | | | | | — | | | | | | 5,977 | | |
|
Research and development
|
| | | | 72,101 | | | | | | (587) | | | | | | — | | | | | | 307 | | | | | | 71,821 | | | | | | (747) | | | | | | — | | | | | | 71,074 | | |
|
Selling, general and administrative
|
| | | | 126,441 | | | | | | (7,234) | | | | | | — | | | | | | (2,860) | | | | | | 116,347 | | | | | | (20,473) | | | | | | — | | | | | | 95,874 | | |
|
Total costs and expenses
|
| | | | 282,237 | | | | | | (24,698) | | | | | | — | | | | | | (10,172) | | | | | | 247,367 | | | | | | (74,442) | | | | | | — | | | | | | 172,925 | | |
|
Income (loss) from operations
|
| | | | (69,421) | | | | | | (2,281) | | | | | | — | | | | | | 2,664 | | | | | | (69,038) | | | | | | (85,231) | | | | | | — | | | | | | (154,269) | | |
|
Interest expense
|
| | | | (21,812) | | | | | | — | | | | | | 6,478 | | | | | | 54 | | | | | | (15,280) | | | | | | 2,467 | | | | | | 3,591 | | | | | | (9,222) | | |
|
Gain on Sale Transactions,
net |
| | | | 176,646 | | | | | | (153,784) | | | | | | — | | | | | | (22,862) | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Loss on debt extinguishment
|
| | | | (12,630) | | | | | | — | | | | | | — | | | | | | — | | | | | | (12,630) | | | | | | — | | | | | | — | | | | | | (12,630) | | |
|
Other income (expense), net
|
| | | | 6,420 | | | | | | — | | | | | | — | | | | | | — | | | | | | 6,420 | | | | | | — | | | | | | — | | | | | | 6,420 | | |
|
Income (loss) before income
taxes |
| | | | 79,203 | | | | | | (156,065) | | | | | | 6,478 | | | | | | (20,144) | | | | | | (90,528) | | | | | | (82,764) | | | | | | 3,591 | | | | | | (169,701) | | |
|
Income tax provision
(benefit) |
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Net income (loss) from continuing operations
|
| | | $ | 79,203 | | | | | $ | (156,065) | | | | | $ | 6,478 | | | | | $ | (20,144) | | | | | $ | (90,528) | | | | | $ | (82,764) | | | | | $ | 3,591 | | | | | $ | (169,701) | | |
|
Net income (loss) per share from
continuing operations: |
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Basic
|
| | | $ | 0.69 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | $ | (1.48) | | |
|
Diluted
|
| | | $ | 0.65 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | $ | (1.48) | | |
|
Weighted-average number of shares used in computing net income (loss) per share from continuing operations:
|
| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Basic
|
| | | | 114,263,256 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 114,279,341 | | |
|
Diluted
|
| | | | 126,563,551 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 114,279,341 | | |
| | | |
Historical
|
| | | | | | | | | | |
CIMERLI Disposition
|
| | | | | | | | | | | | | |
Transaction
|
| | | | | | | | | | |||||||||||||||||||||||||||
| | | |
Coherus
|
| |
Pre-Acquisition
Surface |
| |
Surface
Transaction Accounting Adjustments |
| |
Notes
|
| |
CIMERLI
Disposition (4f) |
| |
CIMERLI
Transaction Accounting Adjustment (4g) |
| |
YUSIMRY
Disposition (4h) |
| |
Subtotal
adjusted for historical transactions |
| |
Transaction (4i)
|
| |
UDENYCA
Transaction Accounting Adjustments |
| |
Notes
|
| |
Combined
Statements of Operations |
| ||||||||||||||||||||||||||||||
|
Net revenue
|
| | | $ | 257,244 | | | | | $ | — | | | | | $ | — | | | | | | | | $ | (125,388) | | | | | $ | — | | | | | $ | (3,574) | | | | | $ | 128,282 | | | | | $ | (127,064) | | | | | $ | — | | | | | | | | $ | 1,218 | | |
| Costs and expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 158,992 | | | | | | — | | | | | | 622 | | | |
4e
|
| | | | (73,975) | | | | | | — | | | | | | (50,668) | | | | | | 34,971 | | | | | | (33,911) | | | | | | — | | | | | | | | | 1,060 | | |
|
Research and development
|
| | | | 109,436 | | | | | | 37,505 | | | | | | (1,663) | | | |
4b
|
| | | | (2,605) | | | | | | — | | | | | | (4,812) | | | | | | 134,934 | | | | | | (5,909) | | | | | | 212 | | | |
4k
|
| | | | 129,237 | | |
| | | | | | | | | | | | — | | | | | | (2,927) | | | |
4c
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | |
|
Selling, general and administrative
|
| | | | 192,015 | | | | | | 19,647 | | | | | | 1,060 | | | |
4b
|
| | | | (32,298) | | | | | | — | | | | | | (7,774) | | | | | | 170,742 | | | | | | (31,485) | | | | | | 443 | | | |
4k
|
| | | | 139,700 | | |
| | | | | | | | | | | | — | | | | | | (1,908) | | | |
4c
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | | | | | | |
|
Restructuring
charges |
| | | | — | | | | | | 12,009 | | | | | | — | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | 12,009 | | | | | | — | | | | | | — | | | | | | | | | 12,009 | | |
|
Total costs and
expenses |
| | | | 460,443 | | | | | | 69,161 | | | | | | (4,816) | | | | | | | | | (108,878) | | | | | | — | | | | | | (63,254) | | | | | | 352,656 | | | | | | (71,305) | | | | | | 655 | | | | | | | | | 282,006 | | |
|
Income (loss) from operations
|
| | | | (203,199) | | | | | | (69,161) | | | | | | 4,816 | | | | | | | | | (16,510) | | | | | | — | | | | | | 59,680 | | | | | | (224,374) | | | | | | (55,759) | | | | | | (655) | | | | | | | | | (280,788) | | |
|
Interest expense
|
| | | | (40,542) | | | | | | (4,040) | | | | | | 1,584 | | | |
4a
|
| | | | — | | | | | | 22,561 | | | | | | — | | | | | | (20,437) | | | | | | — | | | | | | 4,763 | | | |
4j
|
| | | | (15,674) | | |
|
Loss on debt extinguishment
|
| | | | — | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | (8,225) | | | |
4j
|
| | | | (8,225) | | |
|
Other income (expense),
net |
| | | | 5,469 | | | | | | 1,816 | | | | | | (1,792) | | | |
4d
|
| | | | (68) | | | | | | — | | | | | | — | | | | | | 5,425 | | | | | | (676) | | | | | | — | | | | | | | | | 4,749 | | |
|
Income (loss) before
income taxes |
| | | | (238,272) | | | | | | (71,385) | | | | | | 4,608 | | | | | | | | | (16,578) | | | | | | 22,561 | | | | | | 59,680 | | | | | | (239,386) | | | | | | (56,435) | | | | | | (4,117) | | | | | | | | | (299,938) | | |
|
Income tax provision (benefit)
|
| | | | (380) | | | | | | — | | | | | | — | | | | | | | | | — | | | | | | — | | | | | | — | | | | | | (380) | | | | | | — | | | | | | — | | | | | | | | | (380) | | |
|
Net income (loss) from continuing
operations |
| | | $ | (237,892) | | | | | $ | (71,385) | | | | | $ | 4,608 | | | | | | | | $ | (16,578) | | | | | $ | 22,561 | | | | | $ | 59,680 | | | | | $ | (239,006) | | | | | $ | (56,435) | | | | | $ | (4,117) | | | | | | | | $ | (299,558) | | |
|
Basic and diluted net loss
per share from continuing operations |
| | | $ | (2.53) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | $ | (2.92) | | |
|
Weighted-average number
of shares used in computing basic and diluted net loss per share from continuing operations |
| | | | 94,162,637 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 102,483,643 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Transaction
|
| | | | | | | |||||||||
| | | |
Historical
Coherus |
| |
CIMERLI
Disposition (4f) |
| |
YUSIMRY
Disposition (4h) |
| |
Subtotal
adjusted for historical transactions |
| |
Transaction (4i)
|
| |
UDENYCA
Transaction Accounting Adjustment (4j) |
| |
Combined
Statements of Operations |
| |||||||||||||||||||||
|
Net revenue
|
| | | $ | 211,042 | | | | | $ | (6,946) | | | | | $ | — | | | | | $ | 204,096 | | | | | $ | (203,814) | | | | | $ | — | | | | | $ | 282 | | |
| Costs and expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 70,083 | | | | | | (4,029) | | | | | | (149) | | | | | | 65,905 | | | | | | (65,905) | | | | | | — | | | | | | — | | |
|
Research and
development |
| | | | 199,358 | | | | | | (2,201) | | | | | | (26,280) | | | | | | 170,877 | | | | | | (14,348) | | | | | | — | | | | | | 156,529 | | |
|
Selling, general and administrative
|
| | | | 198,481 | | | | | | (17,373) | | | | | | (7,968) | | | | | | 173,140 | | | | | | (37,589) | | | | | | — | | | | | | 135,551 | | |
|
Restructuring charges
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Total costs and expenses
|
| | | | 467,922 | | | | | | (23,603) | | | | | | (34,397) | | | | | | 409,922 | | | | | | (117,842) | | | | | | — | | | | | | 292,080 | | |
|
Income (loss) from operations
|
| | | | (256,880) | | | | | | 16,657 | | | | | | 34,397 | | | | | | (205,826) | | | | | | (85,972) | | | | | | — | | | | | | (291,798) | | |
|
Interest expense
|
| | | | (32,474) | | | | | | — | | | | | | — | | | | | | (32,474) | | | | | | — | | | | | | 4,736 | | | | | | (27,738) | | |
|
Loss on debt extinguishment
|
| | | | (6,222) | | | | | | — | | | | | | — | | | | | | (6,222) | | | | | | — | | | | | | — | | | | | | (6,222) | | |
|
Other income (expense),
net |
| | | | 3,822 | | | | | | — | | | | | | (11) | | | | | | 3,811 | | | | | | (13) | | | | | | — | | | | | | 3,798 | | |
|
Income (loss) before income taxes
|
| | | | (291,754) | | | | | | 16,657 | | | | | | 34,386 | | | | | | (240,711) | | | | | | (85,985) | | | | | | 4,736 | | | | | | (321,960) | | |
|
Income tax provision (benefit)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Net income (loss) from continuing operations
|
| | | $ | (291,754) | | | | | $ | 16,657 | | | | | $ | 34,386 | | | | | $ | (240,711) | | | | | $ | (85,985) | | | | | $ | 4,736 | | | | | $ | (321,960) | | |
|
Basic and diluted net loss per share from
continuing operations |
| | | $ | (3.76) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | $ | (4.15) | | |
|
Weighted-average number of shares used
in computing basic and diluted net loss per share from continuing operations |
| | | | 77,630,020 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 77,630,020 | | |
| | | | | | | | | | | | | | | | | | | | | | | | | | | |
Transaction
|
| | | | | | | |||||||||
| | | |
Historical
Coherus |
| |
CIMERLI
Disposition (4f) |
| |
YUSIMRY
Disposition (4h) |
| |
Subtotal
adjusted for historical transactions |
| |
Transaction (4i)
|
| |
UDENYCA
Transaction Accounting Adjustment (4j) |
| |
Combined
Statements of Operations |
| |||||||||||||||||||||
|
Net revenue
|
| | | $ | 326,551 | | | | | $ | — | | | | | $ | — | | | | | $ | 326,551 | | | | | $ | (326,509) | | | | | $ | — | | | | | $ | 42 | | |
| Costs and expenses: | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 57,591 | | | | | | — | | | | | | — | | | | | | 57,591 | | | | | | (57,591) | | | | | | — | | | | | | — | | |
|
Research and
development |
| | | | 363,105 | | | | | | (2,281) | | | | | | (48,607) | | | | | | 312,217 | | | | | | (42,958) | | | | | | — | | | | | | 269,259 | | |
|
Selling, general and administrative
|
| | | | 169,713 | | | | | | (3,522) | | | | | | (1,329) | | | | | | 164,862 | | | | | | (38,787) | | | | | | — | | | | | | 126,075 | | |
|
Restructuring charges
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Total costs and expenses
|
| | | | 590,409 | | | | | | (5,803) | | | | | | (49,936) | | | | | | 534,670 | | | | | | (139,336) | | | | | | — | | | | | | 395,334 | | |
|
Income (loss) from operations
|
| | | | (263,858) | | | | | | 5,803 | | | | | | 49,936 | | | | | | (208,119) | | | | | | (187,173) | | | | | | — | | | | | | (395,292) | | |
|
Interest expense
|
| | | | (22,959) | | | | | | — | | | | | | — | | | | | | (22,959) | | | | | | — | | | | | | 4,709 | | | | | | (18,250) | | |
|
Loss on debt extinguishment
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Other income (expense),
net |
| | | | (283) | | | | | | — | | | | | | (2) | | | | | | (285) | | | | | | 369 | | | | | | — | | | | | | 84 | | |
|
Income (loss) before income taxes
|
| | | | (287,100) | | | | | | 5,803 | | | | | | 49,934 | | | | | | (231,363) | | | | | | (186,804) | | | | | | 4,709 | | | | | | (413,458) | | |
|
Income tax provision (benefit)
|
| | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | | | | | — | | |
|
Net income (loss) from continuing operations
|
| | | $ | (287,100) | | | | | $ | 5,803 | | | | | $ | 49,934 | | | | | $ | (231,363) | | | | | $ | (186,804) | | | | | $ | 4,709 | | | | | $ | (413,458) | | |
|
Basic and diluted net loss per share from
continuing operations |
| | | $ | (3.81) | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | $ | (5.48) | | |
|
Weighted-average number of shares used
in computing basic and diluted net loss per share from continuing operations |
| | | | 75,449,632 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 75,449,632 | | |
|
(amounts in thousands)
|
| | | | | | |
|
Cash received from Purchaser upon the Transaction Closing
|
| | | $ | 483,400 | | |
|
Subtract: Estimated transaction costs after September 30, 2024
|
| | | | (16,804) | | |
|
Net proceeds
|
| | | | 466,596 | | |
|
Subtract: Recorded carrying amount of net assets sold and derecognized upon
disposition |
| | | | (123,955) | | |
|
Adjustment for pro forma gain on the Transaction
|
| | | $ | 342,641 | | |
|
(amounts in thousands, except share and per share amounts)
|
| |
Nine
Months Ended September 30, 2024 |
| |
Year Ended December 31,
|
| ||||||||||||||||||
| |
2023
|
| |
2022
|
| |
2021
|
| |||||||||||||||||
|
Pro forma net loss from continuing operations
|
| | | $ | (169,701) | | | | | $ | (299,558) | | | | | $ | (321,960) | | | | | $ | (413,458) | | |
|
Weighted average common shares outstanding, excluding the Combined Transactions
|
| | | | 114,257,467 | | | | | | 90,329,209 | | | | | | 77,630,020 | | | | | | 75,449,632 | | |
|
Coherus common stock to Surface shareholders as consideration
|
| | | | — | | | | | | 11,971,460 | | | | | | — | | | | | | — | | |
|
Coherus common stock issued to Surface former
employees as part of Surface Merger consideration |
| | | | — | | | | | | 161,100 | | | | | | — | | | | | | — | | |
|
Shares that vested, net of shares withheld for
taxes, in connection with the transfer of certain employees to Sandoz |
| | | | 7,411 | | | | | | 7,411 | | | | | | — | | | | | | — | | |
|
Estimated shares to vest, net of shares withheld for taxes, in connection with the transfer of certain employees to Intas
|
| | | | 14,463 | | | | | | 14,463 | | | | | | — | | | | | | — | | |
|
Pro forma weighted average number of shares – basic and diluted**
|
| | | | 114,279,341 | | | | | | 102,483,643 | | | | | | 77,630,020 | | | | | | 75,449,632 | | |
|
Basic and diluted net loss per share from continuing operations
|
| | | $ | (1.48) | | | | | $ | (2.92) | | | | | $ | (4.15) | | | | | $ | (5.48) | | |
| | | |
Dilutive Potential Shares
|
| |||||||||||||||||||||
| | | |
Nine
Months Ended September 30, 2024 |
| |
Year Ended December 31,
|
| ||||||||||||||||||
| |
2023
|
| |
2022
|
| |
2021
|
| |||||||||||||||||
|
Stock options, including shares subject to ESPP
|
| | | | 28,669,670 | | | | | | 24,083,222 | | | | | | 22,214,875 | | | | | | 19,895,097 | | |
|
Restricted stock units
|
| | | | 936,711 | | | | | | 2,266,387 | | | | | | 2,399,465 | | | | | | 1,811,607 | | |
|
Shares issuable upon conversion of 2022 Convertible
Notes |
| | | | — | | | | | | — | | | | | | 1,078,632 | | | | | | 4,473,871 | | |
|
Shares issuable upon conversion of 2026 Convertible
Notes |
| | | | — | | | | | | — | | | | | | 11,942,152 | | | | | | 11,942,152 | | |
|
Total
|
| | | | 29,606,381 | | | | | | 26,349,609 | | | | | | 37,635,124 | | | | | | 38,122,727 | | |
| | | |
Page
|
| |||
| Unaudited Combined Annual Financial Statements | | | | | | | |
| | | | | F-19 | | | |
| | | | | F-20 | | | |
| | | | | F-21 | | | |
| | | | | F-22 | | | |
| | | | | F-23 | | | |
| Unaudited Condensed Combined Interim Financial Statements | | | | | | | |
| | | | | F-35 | | | |
| | | | | F-36 | | | |
| | | | | F-37 | | | |
| | | | | F-38 | | | |
| | | | | F-39 | | | |
| | | |
December 31,
2023 |
| |
December 31,
2022 |
| ||||||
| Assets | | | | | | | | | | | | | |
| Current assets: | | | | | | | | | | | | | |
|
Trade receivables, net
|
| | | $ | 114,712 | | | | | $ | 97,046 | | |
|
Inventory
|
| | | | 40,073 | | | | | | 29,339 | | |
|
Prepaid manufacturing
|
| | | | 5,632 | | | | | | 3,858 | | |
|
Other prepaids and current assets
|
| | | | 2,079 | | | | | | 7,302 | | |
|
Total current assets
|
| | | | 162,496 | | | | | | 137,545 | | |
|
Property and equipment, net
|
| | | | 954 | | | | | | 2,569 | | |
|
Inventory, non-current
|
| | | | 54,086 | | | | | | 60,730 | | |
|
Other assets, non-current
|
| | | | 84 | | | | | | — | | |
|
Total assets
|
| | | $ | 217,620 | | | | | $ | 200,844 | | |
| Liabilities and Net Parent Investment | | | | | | | | | | | | | |
| Current liabilities: | | | | | | | | | | | | | |
|
Accounts payable
|
| | | $ | 7,187 | | | | | $ | 4,691 | | |
|
Accrued rebates, fees and reserves
|
| | | | 73,566 | | | | | | 52,399 | | |
|
Accrued compensation
|
| | | | 2,301 | | | | | | 2,150 | | |
|
Accrued and other current liabilities
|
| | | | 9,099 | | | | | | 17,006 | | |
|
Total current liabilities
|
| | | | 92,153 | | | | | | 76,246 | | |
|
Lease liabilities, non-current
|
| | | | 315 | | | | | | 1,195 | | |
|
Total liabilities
|
| | | | 92,468 | | | | | | 77,441 | | |
| Commitments and contingencies (Note 6) | | | | | | | | | | | | | |
|
Net Parent Investment
|
| | | | 125,152 | | | | | | 123,403 | | |
|
Total liabilities and Net Parent Investment
|
| | | $ | 217,620 | | | | | $ | 200,844 | | |
| | | |
2023
|
| |
2022
|
| ||||||
|
Net revenue
|
| | | $ | 127,064 | | | | | $ | 203,814 | | |
| Costs and expenses: | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 33,911 | | | | | | 65,905 | | |
|
Research and development
|
| | | | 15,162 | | | | | | 30,137 | | |
|
Selling, general and administrative
|
| | | | 75,769 | | | | | | 123,631 | | |
|
Total costs and expenses
|
| | | | 124,842 | | | | | | 219,673 | | |
|
Income (loss) from operations
|
| | | | 2,222 | | | | | | (15,859) | | |
|
Interest expense
|
| | | | (72) | | | | | | (160) | | |
|
Other income (expense), net
|
| | | | 676 | | | | | | 13 | | |
|
Income (loss) before income taxes
|
| | | | 2,826 | | | | | | (16,006) | | |
|
Income tax provision
|
| | | | — | | | | | | — | | |
|
Net income (loss)
|
| | | $ | 2,826 | | | | | $ | (16,006) | | |
| | | |
Total
Net Parent Investment |
| |||
|
Balance at December 31, 2021
|
| | | $ | 127,220 | | |
|
Net loss
|
| | | | (16,006) | | |
|
Stock-based compensation expense
|
| | | | 26,559 | | |
|
Transfers to parent, net
|
| | | | (14,370) | | |
|
Balance at December 31, 2022
|
| | | | 123,403 | | |
|
Net income
|
| | | | 2,826 | | |
|
Stock-based compensation expense
|
| | | | 14,699 | | |
|
Transfers to parent, net
|
| | | | (15,776) | | |
|
Balance at December 31, 2023
|
| | | $ | 125,152 | | |
| | | |
2023
|
| |
2022
|
| ||||||
| Operating activities | | | | | | | | | | | | | |
|
Net income (loss)
|
| | | $ | 2,826 | | | | | $ | (16,006) | | |
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
| | | | | | | | | | | | |
|
Depreciation and amortization
|
| | | | 1,379 | | | | | | 1,778 | | |
|
Stock-based compensation expense
|
| | | | 14,716 | | | | | | 26,155 | | |
|
Inventory write-downs, net
|
| | | | 3,268 | | | | | | 26,000 | | |
|
Non-cash operating lease expense
|
| | | | 888 | | | | | | 1,349 | | |
|
Other non-cash adjustments, net
|
| | | | (1,033) | | | | | | 5 | | |
|
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
|
Trade receivables, net
|
| | | | (17,709) | | | | | | 25,970 | | |
|
Inventory
|
| | | | (7,375) | | | | | | (22,413) | | |
|
Prepaid manufacturing
|
| | | | (1,774) | | | | | | 6,077 | | |
|
Other prepaid, current and non-current assets
|
| | | | 4,251 | | | | | | (3,427) | | |
|
Accounts payable
|
| | | | 2,496 | | | | | | (2,046) | | |
|
Accrued rebates, fees and reserves
|
| | | | 21,167 | | | | | | (26,628) | | |
|
Accrued compensation
|
| | | | 151 | | | | | | 334 | | |
|
Accrued and other current and non-current liabilities
|
| | | | (7,137) | | | | | | (1,623) | | |
|
Net cash provided by operating activities
|
| | | | 16,114 | | | | | | 15,525 | | |
| Investing activities | | | | | | | | | | | | | |
|
Proceeds from disposal of property and equipment
|
| | | | 770 | | | | | | — | | |
|
Net cash provided by investing activities
|
| | | | 770 | | | | | | — | | |
| Financing activities | | | | | | | | | | | | | |
|
Transfers to parent, net
|
| | | | (15,965) | | | | | | (14,737) | | |
|
Other financing activities
|
| | | | (919) | | | | | | (788) | | |
|
Net cash used in financing activities
|
| | | | (16,884) | | | | | | (15,525) | | |
|
Net increase (decrease) in cash
|
| | | | — | | | | | | — | | |
|
Cash at beginning of period
|
| | | | — | | | | | | — | | |
|
Cash at end of period
|
| | | $ | — | | | | | $ | — | | |
| | | |
2023
|
| |
2022
|
| ||||||
|
McKesson Corporation
|
| | | | 41% | | | | | | 38% | | |
|
Cencora (previously known as AmeriSource-Bergen Corporation)
|
| | | | 38% | | | | | | 44% | | |
|
Cardinal Health, Inc.
|
| | | | 20% | | | | | | 17% | | |
|
(in thousands)
|
| |
Chargebacks
and Discounts
for Prompt
Payment
|
| |
Rebates
|
| |
Other Fees,
Co-pay
Assistance
and Returns
|
| |
Total
|
| ||||||||||||
|
Balances at December 31, 2021
|
| | | $ | 29,665 | | | | | $ | 54,004 | | | | | $ | 26,054 | | | | | $ | 109,723 | | |
|
Provision related to sales made in:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
|
Current period
|
| | | | 436,618 | | | | | | 64,362 | | | | | | 71,983 | | | | | | 572,963 | | |
|
Prior period – increase (decrease)
|
| | | | (2,090) | | | | | | (1,050) | | | | | | 32 | | | | | | (3,108) | | |
|
Payments and customer credits issued
|
| | | | (421,722) | | | | | | (82,641) | | | | | | (80,345) | | | | | | (584,708) | | |
|
Balances at December 31, 2022
|
| | | | 42,471 | | | | | | 34,675 | | | | | | 17,724 | | | | | | 94,870 | | |
|
Provision related to sales made in:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
|
Current period
|
| | | | 568,420 | | | | | | 62,135 | | | | | | 74,708 | | | | | | 705,263 | | |
|
Prior period – increase (decrease)
|
| | | | (1,362) | | | | | | 1,374 | | | | | | 3,943 | | | | | | 3,955 | | |
|
Payments and customer credits issued
|
| | | | (540,836) | | | | | | (53,232) | | | | | | (67,761) | | | | | | (661,829) | | |
|
Balances at December 31, 2023
|
| | | $ | 68,693 | | | | | $ | 44,952 | | | | | $ | 28,614 | | | | | $ | 142,259 | | |
| | | |
December 31,
|
| |||||||||
|
(in thousands)
|
| |
2023
|
| |
2022
|
| ||||||
|
Raw materials
|
| | | $ | 8,296 | | | | | $ | 7,913 | | |
|
Work in process
|
| | | | 73,934 | | | | | | 65,295 | | |
|
Finished goods
|
| | | | 11,929 | | | | | | 16,861 | | |
|
Total
|
| | | $ | 94,159 | | | | | $ | 90,069 | | |
| | | |
December 31,
|
| |||||||||
|
(in thousands)
|
| |
2023
|
| |
2022
|
| ||||||
|
Inventory
|
| | | $ | 40,073 | | | | | $ | 29,339 | | |
|
Inventory, non-current
|
| | | | 54,086 | | | | | | 60,730 | | |
|
Total
|
| | | $ | 94,159 | | | | | $ | 90,069 | | |
|
(in thousands)
|
| |
December 31,
2023 |
| |
December 31,
2022 |
| ||||||
|
Accrued commercial and research and development manufacturing
|
| | | $ | 5,280 | | | | | $ | 12,460 | | |
|
Accrued other
|
| | | | 3,173 | | | | | | 3,542 | | |
|
Lease liabilities, current
|
| | | | 646 | | | | | | 1,004 | | |
|
Total Accrued and other current liabilities
|
| | | $ | 9,099 | | | | | $ | 17,006 | | |
|
Year ending December 31, (in thousands)
|
| | | | | | |
|
2024
|
| | | $ | 39,558 | | |
|
2025
|
| | | | 10,639 | | |
|
2026
|
| | | | 1,150 | | |
|
Total obligations
|
| | | $ | 51,347 | | |
| | | |
Year Ended December 31,
|
| |||||||||
|
(in thousands)
|
| |
2023
|
| |
2022
|
| ||||||
|
Cost of goods sold(1)
|
| | | $ | 535 | | | | | $ | 736 | | |
|
Research and development
|
| | | | 2,640 | | | | | | 4,479 | | |
|
Selling, general and administrative
|
| | | | 11,541 | | | | | | 20,940 | | |
|
Stock-based compensation expense
|
| | | $ | 14,716 | | | | | $ | 26,155 | | |
|
Stock-based compensation expense capitalized into inventory
|
| | | $ | 518 | | | | | $ | 1,140 | | |
| | | |
Year Ended December 31,
|
| |||||||||
| | | |
2023
|
| |
2022
|
| ||||||
| Expected term (years) | | | | | | | | | | | | | |
|
Stock options
|
| | | | 6.0 | | | | | | 6.1 | | |
|
ESPP
|
| | | | 0.5 | | | | | | 0.5 | | |
| Expected volatility | | | | | | | | | | | | | |
|
Stock options
|
| | | | 64% | | | | | | 62% | | |
|
ESPP
|
| | | | 105% | | | | | | 70% | | |
| Risk-free interest rate | | | | | | | | | | | | | |
|
Stock options
|
| | | | 3.92% | | | | | | 2.37% | | |
|
ESPP
|
| | | | 5.35% | | | | | | 3.77% | | |
| Expected dividend yield | | | | | | | | | | | | | |
|
Stock options
|
| | | | —% | | | | | | —% | | |
|
ESPP
|
| | | | —% | | | | | | —% | | |
| | | |
Year Ended December 31,
|
| |||||||||
|
(in thousands)
|
| |
2023
|
| |
2022
|
| ||||||
|
Domestic
|
| | | $ | 2,826 | | | | | $ | (16,006) | | |
|
Foreign
|
| | | | — | | | | | | — | | |
|
Total
|
| | | $ | 2,826 | | | | | $ | (16,006) | | |
| | | |
Year Ended December 31,
|
| |||||||||
| | | |
2023
|
| |
2022
|
| ||||||
| Percent of pre-tax income: | | | | | | | | | | | | | |
|
United States federal statutory income tax rate
|
| | | | 21.0% | | | | | | 21.0% | | |
|
State taxes, net of federal benefit
|
| | | | 32.8 | | | | | | 8.2 | | |
|
Permanent items
|
| | | | 2.6 | | | | | | — | | |
|
Research and development credit
|
| | | | — | | | | | | 3.0 | | |
|
Stock-based compensation costs
|
| | | | 23.8 | | | | | | (2.1) | | |
|
Change in valuation allowance
|
| | | | (80.2) | | | | | | (30.1) | | |
|
Effective income tax rate
|
| | | | —% | | | | | | —% | | |
| | | |
December 31,
|
| |||||||||
|
(in thousands)
|
| |
2023
|
| |
2022
|
| ||||||
|
Net operating loss carryforwards
|
| | | $ | 17,700 | | | | | $ | 21,459 | | |
|
Research and development credits
|
| | | | 15,617 | | | | | | 15,617 | | |
|
Stock-based compensation
|
| | | | 13,146 | | | | | | 11,650 | | |
|
Sales related accruals
|
| | | | 22,459 | | | | | | 22,769 | | |
|
Other accruals
|
| | | | 470 | | | | | | 1,192 | | |
|
Capitalized research and development
|
| | | | 3,670 | | | | | | 2,940 | | |
|
Gross deferred tax assets
|
| | | | 73,062 | | | | | | 75,627 | | |
|
Right-of-use asset
|
| | | | (203) | | | | | | (501) | | |
|
Gross deferred tax liabilities
|
| | | | (203) | | | | | | (501) | | |
|
Total net deferred tax asset
|
| | | | 72,859 | | | | | | 75,126 | | |
|
Less valuation allowance
|
| | | | (72,859) | | | | | | (75,126) | | |
|
Net deferred tax assets (liabilities)
|
| | | $ | — | | | | | $ | — | | |
| | | |
September 30,
2024 |
| |
December 31,
2023 |
| ||||||
| Assets | | | | | | | | | | | | | |
| Current assets: | | | | | | | | | | | | | |
|
Trade receivables, net
|
| | | $ | 158,316 | | | | | $ | 114,712 | | |
|
Inventory
|
| | | | 45,506 | | | | | | 40,073 | | |
|
Prepaid manufacturing
|
| | | | 5,040 | | | | | | 5,632 | | |
|
Other prepaids and current assets
|
| | | | 4,058 | | | | | | 2,079 | | |
|
Total current assets
|
| | | | 212,920 | | | | | | 162,496 | | |
|
Property and equipment, net
|
| | | | 14 | | | | | | 954 | | |
|
Inventory, non-current
|
| | | | 71,375 | | | | | | 54,086 | | |
|
Other assets, non-current
|
| | | | 241 | | | | | | 84 | | |
|
Total assets
|
| | | $ | 284,550 | | | | | $ | 217,620 | | |
| Liabilities and Net Parent Investment | | | | | | | | | | | | | |
| Current liabilities: | | | | | | | | | | | | | |
|
Accounts payable
|
| | | $ | 10,958 | | | | | $ | 7,187 | | |
|
Accrued rebates, fees and reserves
|
| | | | 151,995 | | | | | | 73,566 | | |
|
Accrued compensation
|
| | | | 2,217 | | | | | | 2,301 | | |
|
Accrued and other current liabilities
|
| | | | 22,367 | | | | | | 9,099 | | |
|
Total current liabilities
|
| | | | 187,537 | | | | | | 92,153 | | |
|
Other liabilities, non-current
|
| | | | 16,120 | | | | | | 315 | | |
|
Total liabilities
|
| | | | 203,657 | | | | | | 92,468 | | |
| Commitments and contingencies (Note 8) | | | | | | | | | | | | | |
|
Net Parent Investment
|
| | | | 80,893 | | | | | | 125,152 | | |
|
Total liabilities and Net Parent Investment
|
| | | $ | 284,550 | | | | | $ | 217,620 | | |
| | | |
Nine Months Ended
September 30, |
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
Net revenue
|
| | | $ | 159,673 | | | | | $ | 90,875 | | |
| Costs and expenses: | | | | | | | | | | | | | |
|
Cost of goods sold
|
| | | | 53,222 | | | | | | 28,551 | | |
|
Research and development
|
| | | | 10,460 | | | | | | 12,904 | | |
|
Selling, general and administrative
|
| | | | 67,264 | | | | | | 59,123 | | |
|
Total costs and expenses
|
| | | | 130,946 | | | | | | 100,578 | | |
|
Income (loss) from operations
|
| | | | 28,727 | | | | | | (9,703) | | |
|
Interest expense
|
| | | | (2,467) | | | | | | (65) | | |
|
Other income (expense), net
|
| | | | 188 | | | | | | 676 | | |
|
Income (loss) before income taxes
|
| | | | 26,448 | | | | | | (9,092) | | |
|
Income tax provision
|
| | | | — | | | | | | — | | |
|
Net income (loss)
|
| | | $ | 26,448 | | | | | $ | (9,092) | | |
| | | |
Total
Net Parent Investment |
| |||
|
Balance at December 31, 2023
|
| | | $ | 125,152 | | |
|
Net income
|
| | | | 26,448 | | |
|
Stock-based compensation expense
|
| | | | 11,779 | | |
|
Transfers to parent, net
|
| | | | (82,486) | | |
|
Balance at September 30, 2024
|
| | | $ | 80,893 | | |
| | | |
Total
Net Parent Investment |
| |||
|
Balance at December 31, 2022
|
| | | $ | 123,403 | | |
|
Net loss
|
| | | | (9,092) | | |
|
Stock-based compensation expense
|
| | | | 11,479 | | |
|
Transfers to parent, net
|
| | | | (11,606) | | |
|
Balance at September 30, 2023
|
| | | $ | 114,184 | | |
| | | |
Nine Months Ended
September 30, |
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
| Operating activities | | | | | | | | | | | | | |
|
Net income (loss)
|
| | | $ | 26,448 | | | | | $ | (9,092) | | |
|
Adjustments to reconcile net income (loss) to net cash provided by operating activities:
|
| | | | | | | | | | | | |
|
Depreciation and amortization
|
| | | | 315 | | | | | | 1,132 | | |
|
Stock-based compensation expense
|
| | | | 11,603 | | | | | | 11,670 | | |
|
Inventory write-downs, net
|
| | | | 2,481 | | | | | | 2,042 | | |
|
Other non-cash adjustments, net
|
| | | | 674 | | | | | | (103) | | |
|
Changes in operating assets and liabilities:
|
| | | | | | | | | | | | |
|
Trade receivables, net
|
| | | | (43,561) | | | | | | 5,059 | | |
|
Inventory
|
| | | | (25,027) | | | | | | (4,872) | | |
|
Prepaid manufacturing
|
| | | | 592 | | | | | | (1,011) | | |
|
Other prepaid, current and non-current assets
|
| | | | (2,726) | | | | | | 4,309 | | |
|
Accounts payable
|
| | | | 3,544 | | | | | | (53) | | |
|
Accrued rebates, fees and reserves
|
| | | | 78,429 | | | | | | 4,306 | | |
|
Accrued compensation
|
| | | | 298 | | | | | | (57) | | |
|
Accrued and other current and non-current liabilities
|
| | | | 5,865 | | | | | | (1,538) | | |
|
Net cash provided by operating activities
|
| | | | 58,935 | | | | | | 11,792 | | |
| Investing activities | | | | | | | | | | | | | |
|
Other investing activities, net
|
| | | | 214 | | | | | | 676 | | |
|
Net cash provided by investing activities
|
| | | | 214 | | | | | | 676 | | |
| Financing activities | | | | | | | | | | | | | |
|
Proceeds from Revenue Purchase and Sale Agreement, net of issuance costs
|
| | | | 23,943 | | | | | | — | | |
|
Transfers to parent, net
|
| | | | (82,786) | | | | | | (11,686) | | |
|
Other financing activities
|
| | | | (306) | | | | | | (782) | | |
|
Net cash used in financing activities
|
| | | | (59,149) | | | | | | (12,468) | | |
|
Net increase in cash
|
| | | | — | | | | | | — | | |
|
Cash at beginning of period
|
| | | | — | | | | | | — | | |
|
Cash at end of period
|
| | | $ | — | | | | | $ | — | | |
| | | |
Nine Months Ended
September 30, |
| |||||||||
| | | |
2024
|
| |
2023
|
| ||||||
|
McKesson Corporation
|
| | | | 42% | | | | | | 41% | | |
|
Cencora (previously known as AmeriSource-Bergen Corporation)
|
| | | | 38% | | | | | | 39% | | |
|
Cardinal Health, Inc.
|
| | | | 19% | | | | | | 19% | | |
| | | |
Nine Months Ended September 30, 2024
|
| |||||||||||||||||||||
|
(in thousands)
|
| |
Chargebacks
and Discounts for Prompt Payment |
| |
Rebates
|
| |
Other Fees,
Co-pay Assistance and Returns |
| |
Total
|
| ||||||||||||
|
Balances at December 31, 2023
|
| | | $ | 68,693 | | | | | $ | 44,952 | | | | | $ | 28,614 | | | | | $ | 142,259 | | |
|
Provision related to sales made in:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
|
Current period
|
| | | | 713,231 | | | | | | 126,926 | | | | | | 103,724 | | | | | | 943,881 | | |
|
Prior period – increase (decrease)
|
| | | | (876) | | | | | | 4,988 | | | | | | (1,069) | | | | | | 3,043 | | |
|
Payments and customer credits issued
|
| | | | (728,423) | | | | | | (65,001) | | | | | | (91,139) | | | | | | (884,563) | | |
|
Balances at September 30, 2024
|
| | | $ | 52,625 | | | | | $ | 111,865 | | | | | $ | 40,130 | | | | | $ | 204,620 | | |
| | | |
Nine Months Ended September 30, 2023
|
| |||||||||||||||||||||
|
(in thousands)
|
| |
Chargebacks
and Discounts for Prompt Payment |
| |
Rebates
|
| |
Other Fees,
Co-pay Assistance and Returns |
| |
Total
|
| ||||||||||||
|
Balances at December 31, 2022
|
| | | $ | 42,471 | | | | | $ | 34,675 | | | | | $ | 17,724 | | | | | $ | 94,870 | | |
|
Provision related to sales made in:
|
| | | | | | | | | | | | | | | | | | | | | | | | |
|
Current period
|
| | | | 377,653 | | | | | | 33,066 | | | | | | 49,907 | | | | | | 460,626 | | |
|
Prior period – increase (decrease)
|
| | | | (1,376) | | | | | | 1,422 | | | | | | 4,605 | | | | | | 4,651 | | |
|
Payments and customer credits issued
|
| | | | (371,140) | | | | | | (37,515) | | | | | | (47,173) | | | | | | (455,828) | | |
|
Balances at September 30, 2023
|
| | | $ | 47,608 | | | | | $ | 31,648 | | | | | $ | 25,063 | | | | | $ | 104,319 | | |
|
(in thousands)
|
| |
September 30,
2024 |
| |
December 31,
2023 |
| ||||||
|
Raw materials
|
| | | $ | 13,735 | | | | | $ | 8,296 | | |
|
Work in process
|
| | | | 102,526 | | | | | | 73,934 | | |
|
Finished goods
|
| | | | 620 | | | | | | 11,929 | | |
|
Total
|
| | | $ | 116,881 | | | | | $ | 94,159 | | |
|
(in thousands)
|
| |
September 30,
2024 |
| |
December 31,
2023 |
| ||||||
|
Inventory
|
| | | $ | 45,506 | | | | | $ | 40,073 | | |
|
Inventory, non-current
|
| | | | 71,375 | | | | | | 54,086 | | |
|
Total
|
| | | $ | 116,881 | | | | | $ | 94,159 | | |
|
(in thousands)
|
| |
September 30,
2024 |
| |
December 31,
2023 |
| ||||||
|
Accrued commercial and research and development manufacturing
|
| | | $ | 11,183 | | | | | $ | 5,280 | | |
|
UDENYCA Royalty Fee Derivative Liability (Note 7)
|
| | | | 7,962 | | | | | | — | | |
|
Revenue participation liability, current (Note 7)
|
| | | | 2,180 | | | | | | — | | |
|
Accrued other
|
| | | | 1,042 | | | | | | 3,173 | | |
|
Lease liabilities, current
|
| | | | — | | | | | | 646 | | |
|
Total Accrued and other current liabilities
|
| | | $ | 22,367 | | | | | $ | 9,099 | | |
|
(in thousands)
|
| |
September 30,
2024 |
| |
December 31,
2023 |
| ||||||
|
Revenue participation liability, non-current (Note 7)
|
| | | $ | 16,120 | | | | | $ | — | | |
|
Lease liabilities, non-current
|
| | | | — | | | | | | 315 | | |
|
Total Other liabilities, non-current
|
| | | $ | 16,120 | | | | | $ | 315 | | |
|
(in thousands)
|
| |
September 30,
2024 |
| |||
|
Revenue participation liability
|
| | | $ | 24,556 | | |
|
Less unamortized discount and issuance costs
|
| | | | (6,256) | | |
|
Total
|
| | | $ | 18,300 | | |
|
(in thousands)
|
| |
Balance Sheet Classification
|
| |
September 30,
2024 |
| |||
|
Revenue participation liability, current
|
| |
Accrued and other current liabilities
|
| | | $ | 2,180 | | |
|
Revenue participation liability, non-current
|
| | Other liabilities, non-current | | | | | 16,120 | | |
|
Total
|
| | | | | | $ | 18,300 | | |
|
Year ending December 31, (in thousands)
|
| | | | | | |
|
2024
|
| | | $ | 5,996 | | |
|
2025
|
| | | | 47,617 | | |
|
2026
|
| | | | 1,394 | | |
|
2027
|
| | | | 450 | | |
|
Total obligations
|
| | | $ | 55,457 | | |
| | | |
Nine Months Ended
September 30, |
| |||||||||
|
(in thousands)
|
| |
2024
|
| |
2023
|
| ||||||
|
Cost of goods sold(1)
|
| | | $ | 765 | | | | | $ | 478 | | |
|
Research and development
|
| | | | 1,814 | | | | | | 2,290 | | |
|
Selling, general and administrative
|
| | | | 9,024 | | | | | | 8,902 | | |
|
Stock-based compensation expense
|
| | | $ | 11,603 | | | | | $ | 11,670 | | |
|
Stock-based compensation expense capitalized into inventory
|
| | | $ | 941 | | | | | $ | 287 | | |
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