On July 29, 2021 Emergent BioSolutions Inc. (NYSE: EBS) reported financial results for the second quarter ended June 30, 2021 (Press release, Emergent BioSolutions, JUL 29, 2021, View Source [SID1234585365]).

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"Our second quarter performance demonstrates the strength of our strategy and diversified business model," said Robert G. Kramer, president and chief executive officer of Emergent BioSolutions. "Through continued investment and innovation, we will play an important role in helping deliver solutions to the public health threats we face. We are proud to be resuming production of COVID-19 vaccine batches following additional reviews and collaboration with the Food and Drug Administration and our manufacturing partner."

Kramer added, "I am thankful for the relentless determination of our Emergent team across the globe to deliver for our patients, customers and partners."

Q2 2021 AND OTHER RECENT BUSINESS ACCOMPLISHMENTS

Announced that the U.S. Food and Drug Administration (FDA) has informed the Company that it can resume production of Johnson & Johnson’s COVID-19 vaccine bulk drug substance at the Company’s Bayview manufacturing facility.
Supporting the U.S. government’s smallpox preparedness efforts under contract options exercised by the Department of Health and Human Services (HHS) valued at approximately $182 million and $56 million to deliver ACAM2000 (Smallpox (Vaccinia) Vaccine, Live) and VIGIV [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), respectively.
Supporting the Canadian government’s anthrax preparedness efforts under a new contract with the Public Health Agency Canada (PHAC) to deliver Anthrasil (Anthrax Immune Globulin Intravenous [human]) through March 2023.
Received approval from the Federal Agency for Medicines and Health Products (FAMHP) of Belgium for Trobigard Auto-injector (atropine sulfate 2mg/obidoxime chloride 220mg; solution for injection), an emergency treatment product for known or suspected exposure to nerve agents or toxic organophosphates in adults over 18 years of age.
2021 FINANCIAL PERFORMANCE (1)

Product Sales, net
NARCAN Nasal Spray
For Q2 2021, revenues from NARCAN (naloxone HCI) Nasal Spray increased $33.4 million as compared to Q2 2020. The increase is largely driven by a growth in sales to the U.S. public interest and commercial retail markets as well as an increase in sales to customer channels in Canada.

Anthrax vaccines
For Q2 2021, revenues from Anthrax vaccines decreased $80.8 million as compared to Q2 2020. The decrease is largely driven by timing of deliveries to the U.S. government.

ACAM2000
For Q2 2021, revenues from ACAM2000 decreased $70.0 million as compared to Q2 2020. The decrease is largely driven by the timing of deliveries to the U.S. government; the most recent option exercise was received in July 2021 valued at approximately $182 million, the entire amount of which is expected to be delivered in fiscal year 2021.

Other (4)
For Q2 2021, revenues from other product sales were consistent as compared to Q2 2020.

Contract Development and Manufacturing (CDMO) Services
For Q2 2021, revenue from contract development and manufacturing services increased $118.3 million, as compared to Q2 2020. The increase is due to the public-private partnership with the Biomedical Advanced Research and Development Authority (BARDA) and arrangements with pharma/biotech innovators to address the COVID-19 pandemic. These arrangements were entered into during the second and third quarters of 2020.

Contracts and Grants
For Q2 2021, revenues from contracts and grants were consistent as compared to Q2 2020.

Operating Expenses

Cost of Product Sales and CDMO Services
For Q2 2021, cost of product sales and contract development and manufacturing services increased $98.0 million as compared to Q2 2020. The increase primarily consists of an increase in costs associated with the Company’s contract development and manufacturing services due to higher volume of CDMO services, a majority of which were in support of the Company’s arrangements to address the COVID-19 pandemic. Additionally, during the quarter the Company had inventory write-offs of $41.5 million associated with raw materials and in-process batches manufactured at the Company’s Bayview facility that it plans to discard as they were deemed unusable. These increases were partially offset by decreases in the cost of product sales due to less volume.

Research and Development
For Q2 2021, research and development expenses were consistent as compared to Q2 2020.

Selling, General and Administrative
For Q2 2021, selling, general and administrative expenses increased $15.2 million as compared to Q2 2020. The increase is primarily due to an increase in costs related to defending and supporting the Company’s corporate reputation.

Additional Financial Information
Gross Margin (2)

For Q2 2021, gross margin decreased $97.0 million as compared to Q2 2020. The decrease is primarily due to the increase in the cost of product sales and CDMO services, specifically $41.5 million associated with the inventory write-offs, $43.1 million associated with product and service revenue mix which was weighted more heavily to lower margin products and services, and $12.4 million associated with costs incurred to remediate and strengthen manufacturing processes at the Company’s Bayview facility, many of which are considered temporary in nature.

For Q2 2021, CDMO services backlog decreased $245.8 million as compared to Q1 2021. The decrease is primarily due to revenue realized in the quarter of $190.9 million, $108.1 million of negative contract modifications and other adjustments offset by $53.2 million of positive new business generation during the quarter.

For Q2 2021, CDMO services opportunity funnel decreased $135.1 million as compared to Q1 2021. The decrease is primarily due to the exclusion of opportunities at the Company’s Bayview facility as all manufacturing activities at that facility are currently prioritized to support the Johnson & Johnson COVID-19 vaccine.

For Q2 2021, capital expenditures increased largely due to the Company’s continued investments associated with increased capacity and capabilities at the Company’s Rockville and Bayview facilities. The increase in gross capital expenditures was offset by reimbursements of $11.4 million related to arrangements funded by the U.S. government.

2021 FINANCIAL FORECAST

For full year 2021, the Company’s forecast includes the following financial metrics:

The Company’s financial forecast for 2021 includes the following additional considerations:

Revised Considerations

Gross margin reflects the impact of the Q2 2021 performance as well as expectations for the remainder of the year.
Unchanged Considerations

Narcan Nasal Spray revenues assume the naloxone market remains competitive and incorporates the impact of at least one new branded entrant into the market by year end, as well as that no generic entrant will enter the market prior to the anticipated appellate decision related to the pending patent litigation, which is expected in the second half of 2021.
Anthrax vaccines revenues are expected to continue to primarily reflect procurement of AV7909 (Anthrax Vaccine Adsorbed, Adjuvanted)​ under the terms of the Company’s existing contract with BARDA at a more normalized annual level.
ACAM2000, (Smallpox (Vaccinia) Vaccine, Live) vaccine revenues incorporate the expected full delivery of product under the $182 million option exercise received in July 2021 as well as other international sales.
CDMO services revenue reflects the successful manufacturing of Johnson & Johnson’s COVID-19 vaccine bulk drug substance. On July 29, the Company announced that it was informed by the FDA that it can resume production at its Bayview manufacturing facility.
Total revenues, specifically other product sales, are expected to be impacted due to the Company’s assumption that a new raxibacumab contract will be awarded later than previously planned.
R&D expenses are expected to reflect continued pipeline progress across the vaccines, therapeutics, and devices portfolios, including the assumption of at least one Phase 3 launch and one Biologics License Application (BLA)/Emergency Use Authorization (EUA) filing.
Capital expenditures, net of reimbursement, are expected to be in a range of 8% to 9% of total revenues, reflecting ongoing investments in capacity and capability expansions in support of the Company’s CDMO services business and product portfolio.
Q3 2021 REVENUE FORECAST

For Q3 2021, the Company expects total revenues of $400 million to $500 million.

FOOTNOTES

(1) All financial information incorporated within this release is unaudited.
(2) See "Reconciliation of Net Income to Adjusted Net Income," "Reconciliation of Net Income to Adjusted EBITDA," "Reconciliation of Gross Margin" and "Reconciliation of Net Research and Development Expenses" for a definition of terms and the reconciliation tables.
(3) Product sales, net are reported net of variable consideration including returns, rebates, wholesaler fees and prompt pay discounts.
(4) Other can include a combination of sales of any of the following products: BAT, VIGIV, Anthrasil, raxibacumab, RSDL, Trobigard, Vivotif, and Vaxchora.
(5) CDMO backlog is defined as estimated remaining contract value as of the indicated period pursuant to signed contracts, the majority of which is expected to be recognized over the next 24 months.
(6) CDMO new business is defined as initial value of contracts secured as well as incremental value of existing contracts modified within the indicated period and is incorporated into Backlog.
(7) CDMO opportunity funnel is defined as proposal values from new work with new customers, new work with existing customers and extensions/expansions of existing contracts with existing customers that, if converted to new business, the majority of which is expected to be realized over the next 24 months. This excludes any value associated with an extension of the commercial supply agreement (CSA) with Johnson & Johnson.

CONFERENCE CALL, PRESENTATION SUPPLEMENT AND WEBCAST INFORMATION

Company management will host a conference call at 5:00 pm (Eastern Time) today, July 29, 2021, to discuss these financial results. The conference call and presentation supplement can be accessed from the Company’s website or through the following:

On July 29, 2021 OPKO Health, Inc. (NASDAQ: OPK) reported that business highlights and financial results for the three months ended June 30, 2021 (Press release, Opko Health, JUL 29, 2021, View Source [SID1234585364]).

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Business Highlights

BioReference Laboratories (BRL) test volume increased 32% compared with the second quarter of 2020. During the second quarter of 2021, BRL processed approximately 2.8 million COVID-19 PCR tests and has current capacity to process more than 100,000 PCR tests per day. In addition, during the quarter BRL performed approximately 132,000 COVID-19 serology tests to measure SARS-CoV-2 antibody levels and currently has significant additional capacity.

In June 2021, BRL announced a COVID-19 custom testing program for U.S.-based crew and guests who cruise with Royal Caribbean Group, helping provide a safe environment for travelers and crew members. In April 2021, BRL announced a COVID-19 testing agreement for players and staff, stadium employees and league staff for the 2021 Major League Baseball season and the renewal of a similar agreement for the 2021 Major League Soccer season and 2021-2022 National Football League season.

Also, BRL announced the appointment of Katherine Stueland as President and Chief Executive Officer of GeneDx, Inc., its global genomics subsidiary. Ms. Stueland joined GeneDx from Invitae Corporation, where she served most recently as Chief Commercial Officer.
Executed agreement with Nicoya Therapeutics for the development and commercialization of RAYALDEE in Greater China. OPKO entered into an agreement with Nicoya Macau Limited, an affiliate of Nicoya Therapeutics (Nicoya), for the development and commercialization in Greater China including mainland China, Hong Kong, Macau and Taiwan of RAYALDEE for the treatment of secondary hyperparathyroidism (SHPT) in patients with stage 3 or 4 chronic kidney disease (CKD). OPKO received an upfront payment of $5 million and is entitled to receive an additional $5 million payment upon the earlier of the 12-month anniversary of the agreement or Nicoya achieving a certain predetermined development milestone. In addition, OPKO will be eligible to receive up to $115 million upon the achievement of certain development, regulatory and sales-based milestones. Nicoya will pay OPKO tiered, double-digit royalties on product sales and will be responsible for regulatory approvals and commercial activities pertaining to RAYALDEE in their territory.
Executed exclusive worldwide agreement with CAMP4 Therapeutics Corporation (CAMP4) for the development, manufacture and commercialization of therapeutics utilizing the AntagoNAT technology. The AntagoNAT technology is an oligonucleotide platform developed under OPKO CURNA. CAMP4 has prioritized OPKO’s lead AntagoNAT compound to progress into clinical trials for the treatment of Dravet syndrome. Under the terms of the agreement, OPKO received an upfront cash payment and shares of privately held CAMP4. In addition, OPKO will be eligible to receive up to $93.5 million and additional shares upon the achievement of certain development and sales milestones for products developed from this technology and associated intellectual property. CAMP4 will also pay OPKO double-digit royalties on product sales.
Sale of sterile fill-and-finish manufacturing facility in Ireland. OPKO sold one of its facilities in Waterford, Ireland to Horizon Therapeutics plc for $65 million less certain assumed and accrued liabilities relating to transferred employees. The facility previously housed EirGen’s sterile fill-and-finish business.
Second Quarter Financial Results

Diagnostics: Revenue from services in the second quarter of 2021 increased to $397.2 million from $251.0 million in the prior-year period, primarily due to an increase in volume of COVID-19, clinical and genomic testing. Total costs and expenses were $367.2 million in the second quarter of 2021 compared with $216.2 million in the second quarter of 2020, resulting in operating income of $30.0 million compared with $40.9 million in the 2020 period. The decrease in operating income is primarily due to non-recurring benefits in the second quarter of 2020 including $10.9 million of revenue from the successful 4Kscore Medicare appeal and a $6.2 million grant received under the CARES Act.
Pharmaceuticals: Revenue from products in the second quarter of 2021 was $35.7 million compared with $29.3 million in the second quarter of 2020, primarily attributable to accelerating growth within OPKO’s international pharmaceutical businesses partially offset by a decline in sales of RAYALDEE. Total prescriptions for RAYALDEE in the second quarter of 2021 decreased to approximately 11,700 from approximately 18,400 in the second quarter of 2020. Revenue from sales of RAYALDEE in the second quarter of 2021 and 2020 was $5.0 million and $8.6 million, respectively. Revenue from the transfer of intellectual property was $9.5 million in the second quarter of 2021 compared with $14.7 million in the 2020 period, reflecting a decrease in the amortization of payments received from Pfizer with respect to somatrogon. The second quarter of 2021 included a $5.0 million upfront payment under the license agreement with Nicoya. Total costs and expenses were $58.9 million in the second quarter of 2021 compared with $50.0 million in the prior year period, primarily due to the growth of OPKO’s international pharmaceutical operations. Operating loss was $13.7 million in the second quarter of 2021 compared with an operating loss of $6.0 million in the second quarter of 2020.
Consolidated: Consolidated total revenues for the second quarter of 2021 were $442.4 million compared with $301.2 million for the comparable period of 2020. Operating income for the second quarter of 2021 was $5.6 million compared with operating income of $27.2 million for the comparable period of 2020. Net loss for the second quarter of 2021, which included an $11.1 million non-cash, non-recurring loss as a result of the issuance of shares in connection with the $55.4 million convertible notes exchange, was $16.2 million, or $0.03 per share, compared with net income of $33.7 million, or $0.05 per diluted share, for the comparable period of 2020.
Cash and equivalents: Cash, cash equivalents and marketable securities were $65.8 million as of June 30, 2021. The Company has availability under its present line of credit with JP Morgan of $64.3 million. Also, in July 2021 OPKO received gross proceeds of $65.0 million from the sale of its fill-and-finish manufacturing facility in Ireland.
Convertible notes: In May 2021, certain noteholders of the Company’s 4.50% Convertible Senior Notes due 2025 agreed to exchange $55.4 million of the outstanding notes for shares of the Company’s common stock, plus a cash payment equal to the accrued and unpaid interest on the exchanged notes.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update, discuss second quarter financial results and answer questions during a conference call and live audio webcast beginning at 4:30 p.m. Eastern time today, July 29, 2021. Participants are requested to pre-register for the conference call using the link here. Upon pre-registering, participants will receive dial-in numbers, an event passcode and a unique registrant ID to gain immediate access to the call and bypass the live operator. Participants may pre-register at any time, including up to and after the start of the call. Alternatively, please dial (888) 869-1189 or (706) 643-5902 and use conference ID 7028169

To access the live call via webcast, please click on the link OPKO 2Q21 Results Conference Call. Individual investors and investment community professionals who do not plan to ask a question during the call’s Q&A session are encouraged to listen to the call via the webcast.

For those unable to listen to the live conference call, a replay can be accessed for a period of time on OPKO’s website at OPKO 2Q21 Results Conference Call. A telephone replay will be available beginning approximately two hours after the completion of the conference call. To access the replay, please dial (855) 859-2056 or (404) 537-3406, and use conference ID 7028169.

On July 29, 2021 Seagen Inc. (Nasdaq:SGEN) reported financial results for the second quarter and six months ended June 30, 2021 (Press release, Seagen, JUL 29, 2021, View Source [SID1234585363]). The Company also highlighted ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin-ejfv) and TUKYSA (tucatinib) commercial and development accomplishments, as well as progress across its robust oncology pipeline.

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"The commercial execution across our three brands continues to be strong, achieving record quarterly net product sales for each of ADCETRIS, PADCEV and TUKYSA, as we bring these important medicines to patients around the world," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seagen. "We are investing in clinical trials to maximize the potential of our three approved drugs, and making strong progress with TUKYSA commercialization in the European Union. Looking ahead to the remainder of 2021, Seagen is poised to add a fourth product, tisotumab vedotin, which has an FDA action date in October 2021 and we expect continued progress across our earlier-stage oncology pipeline with planned clinical data presentations and other development accomplishments."

PROGRAM HIGHLIGHTS

PADCEV

Received FDA Regular Approval and Additional Indication for mUC: In July 2021, Seagen and Astellas announced that the U.S. Food and Drug Administration (FDA) granted PADCEV regular approval, in addition to approving a new indication for adult patients with locally advanced or metastatic urothelial cancer (la/mUC) who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy. Cisplatin-ineligible patients typically have limited treatment options and a poor prognosis.
Presented Updated Results from Cohort 2 of Pivotal EV-201 Trial: In June 2021, updated results were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting for the second cohort of the EV-201 trial for patients with la/mUC who received prior treatment with an immunotherapy but had not received a platinum-containing chemotherapy and were ineligible for cisplatin chemotherapy. The data showed that with extended follow-up median duration of response increased to 13.8 months. EV-201 results were also published in The Lancet Oncologyandsupported expansion of the PADCEV label in July 2021.
Presented Updated Results from the EV-103 Trial in First-line mUC: In June 2021, updated durability and long-term outcome data were presented at ASCO (Free ASCO Whitepaper) for the initial cohort of the EV-103 trial combining PADCEV and KEYTRUDA (pembrolizumab) for first-line treatment of la/mUC. The updated data after a median follow-up of two years showed median duration of response of 25.6 months and a median overall survival of 26.1 months. The long-term analysis demonstrated a safety profile generally consistent with previous findings. The Company is evaluating the combination in a randomized Cohort K of the EV-103 trial, which is expected to complete enrollment by the end of 2021 and potentially support registration under the FDA’s accelerated approval pathway.
TUKYSA

Presented Long-Term Results for HER2CLIMB Trial at ASCO (Free ASCO Whitepaper): In June 2021, updated analyses of the pivotal HER2CLIMB trial evaluating the addition of TUKYSA to trastuzumab and capecitabine in patients with HER2-positive metastatic breast cancer with and without brain metastases were presented at ASCO (Free ASCO Whitepaper). The data confirmed the overall survival benefit of TUKYSA originally observed with median overall survival for the TUKYSA arm extending to two years. The survival benefit was maintained across all prespecified patient subgroups. The safety profile was generally consistent with the primary analysis.
ADCETRIS

Published 5-year Follow-up Results for ECHELON-1: In June 2021, five-year follow-up results from the ECHELON-1 phase 3 clinical trial were published in Lancet Haematology. Data showed treatment with ADCETRIS in combination with AVD (Adriamycin [doxorubicin], vinblastine and dacarbazine) resulted in superior long-term outcomes when compared to ABVD, which includes bleomycin, in frontline advanced Hodgkin lymphoma.
Tisotumab Vedotin

Tisotumab Vedotin BLA Accepted for Priority Review: In April 2021, FDA accepted for Priority Review the tisotumab vedotin BLA for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The target FDA action date is October 10, 2021. The submission is based on the results of the innovaTV 204 pivotal phase 2 trial, which were published in The Lancet Oncology in April 2021.
For additional information on Seagen’s pipeline, visit www.seagen.com/science/pipeline.

SECOND QUARTER AND SIX-MONTHS 2021 FINANCIAL RESULTS

Revenues: Total revenues for the second quarter and six months ended June 30, 2021 increased to $388.5 million and $720.5 million, respectively, compared to $278.0 million and $512.5 million for the same periods in 2020. Growth over 2020 was primarily driven by higher sales of PADCEV and the addition of TUKYSA to the Company’s commercial portfolio. Revenues are composed of the following three components:

Note: Sum of product sales may not equal total net product sales due to rounding.

Royalty Revenues: Royalty revenues for the second quarter and year-to-date in 2021 were $36.3 million and $63.5 million, respectively, compared to $31.2 million and $51.6 million for the same periods in 2020. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, royalties from sales of Polivy (polatuzumab vedotin) by Roche and Blenrep (belantamab mafodotin) by GlaxoSmithKline, which are ADCs that use Seagen technology.
Collaboration and License Agreement Revenues: Amounts earned under the Company’s product, development and technology collaborations were $4.8 million and $7.0 million in the second quarter and year-to-date in 2021, respectively, compared to $6.3 million and $21.9 million for the same periods in 2020. Collaboration revenues for the year-to-date in 2020 included a regulatory milestone related to Polivy under the collaboration with Roche.
Cost of Sales: Cost of sales for the second quarter and year-to-date in 2021 were $78.1 million and $142.2 million, respectively, compared to $48.2 million and $77.7 million for the same periods in 2020. The increase was primarily due to the PADCEV gross profit share with Astellas, which was $38.6 million and $71.1 million in the second quarter and year-to-date of 2021, respectively, compared to $27.1 million and $43.5 million for the same periods in 2020. The increase in cost of sales also reflected amortization of acquired in-process technology costs that began with the approval of TUKYSA in April 2020, and third-party royalties owed for ADCETRIS, PADCEV and TUKYSA net product sales, in addition to cost of products sold.

Research and Development (R&D) Expenses: R&D expenses for the second quarter and year-to-date in 2021 were $234.9 million and $465.3 million, respectively, compared to $198.1 million and $393.3 million for the same periods in 2020. The increase in 2021 primarily reflected continued investment in clinical development of the Company’s approved drugs and to advance novel programs and technologies.

Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter and year-to-date in 2021 were $165.1 million and $325.0 million, respectively, compared to $125.6 million and $247.9 million for the same periods in 2020. The increases in 2021 primarily reflected investments to support European TUKYSA launches and our global expansion efforts.

Non-cash, share-based compensation expense for the first six months of 2021 was $76.0 million, compared to $68.4 million for the same period in 2020.

Net Loss: Net loss for the second quarter of 2021 was $84.6 million, or $0.47 per diluted share, compared to net loss of $21.2 million, or $0.12 per diluted share, for the second quarter of 2020. Net loss for the six months ended June 30, 2021 was $206.0 million, or $1.14 per diluted share, compared to net loss of $189.6 million, or $1.10 per diluted share, for the same period in 2020.

Cash and Investments: As of June 30, 2021, Seagen had $2.5 billion in cash and investments.

2021 FINANCIAL OUTLOOK

Seagen anticipates 2021 revenues, operating expenses and other costs to be in the ranges shown in the table below, unchanged from the Company’s previous financial guidance provided on February 11, 2021.

Revenues

ADCETRIS net product sales

$675 million to $700 million

PADCEV net product sales

$310 million to $325 million

TUKYSA net product sales

$300 million to $315 million

Royalty revenues

$125 million to $135 million

Collaboration and license agreement revenues

Less than $20 million

Operating expenses and other costs

Cost of Sales

$270 million to $300 million

R&D expenses

$900 million to $1,000 million

SG&A expenses

$650 million to $725 million

Non-cash expenses1 (primarily attributable to share-based compensation)

$225 million to $245 million

1.Non-cash expenses include share-based compensation, depreciation and amortization of intangible assets.
Conference Call Details

Seagen management will host a conference call and webcast with supporting slides to discuss its second quarter 2021 and year-to-date financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event will be simultaneously webcast and available for replay from the Seagen website at www.seagen.com, under the Investors section. Investors may also participate in the conference call by calling 844-763-8274 (domestic) or 412-717-9224 (international). The conference ID is 10157814. Supporting slides are available on the Seagen website at www.seagen.com under the Investors section. A webcast replay will be archived on the Company’s website www.seagen.com, under the Investors section.

On July 29, 2021 Lantern Pharma Inc. (NASDAQ: LTRN) ("Lantern"), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform oncology drug discovery and development reported financial results for the second quarter ended June 30, 2021 (Press release, Lantern Pharma, JUL 29, 2021, View Source [SID1234585362]).

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"We are committed to bringing our pipeline of targeted cancer therapies to patients faster by utilizing our RADR A.I. platform and making continual advances in our portfolio," stated Panna Sharma, President and CEO of Lantern Pharma. "This past quarter we made significant advances in our LP-184 program in pancreatic cancer and in validating the role this potent molecule can play in being synthetically lethal in cancers with DNA repair deficiencies. This opens up opportunities for LP-184 in several additional cancers, such as bladder and ovarian, and as a potential combination agent with existing PARP inhibitors."

"With the recently announced reacquisition of LP-100 earlier this week, we will use insights from the LP-100 trial and investigators to assess further enrollment of the Phase 2 trial in Denmark and initiation of other studies where LP-100 can play a role as a potential cancer therapy. We believe this molecule has the potential to address a market of nearly $200 million in the U.S. and approximately $700 million globally."

Lantern is developing four drug candidates and an ADC program across eight disclosed indications, including:

LP-100 (Irofulven), in a Phase 2 trial for the treatment of metastatic castration resistant prostate cancer (mCRPC), which showed median overall survival (mOS) of 12.5 months in the initial 9 patients.
LP-300, a small molecule drug-candidate that is preparing to enter a Phase 2 trial as a combination therapy in never-smokers with non-small cell lung cancer (NSCLC).
LP-184, a small molecule DNA damaging candidate in preclinical development for genomically-defined pancreatic and bladder cancers, and potentially other cancers that overexpress PTGR1.
LP-184, additionally in brain cancers such as: glioblastoma multiforme (GBM), and atypical teratoid rhabdoid tumors (ATRT) and other undisclosed brain tumors.
LP-284, an alkylating agent that is preferentially active in hematologic cancers and works by blocking transcription of translocated fusion proteins required for survival of such cancers.
LP-A18 – an antibody drug conjugate (ADC) program that is in late stage discovery to optimize conjugation among known and commercially available antibodies, selected based on insights from RADR, with LP-184 or similar high-potency small molecules.
Second Quarter 2021 Financial Highlights

Balance Sheet: Cash, cash equivalents, and marketable securities were $79.6 million as of June 30, 2021, compared to $19.2 million as of December 31, 2020. The increase reflects $69.0 million of gross proceeds from our January 20, 2021 follow-on public offering.
R&D Expenses: Research and development expenses were $1,164,892 for the quarter ended June 30, 2021, compared to $157,023 for the quarter ended June 30, 2020. The increase was primarily attributable to increases in manufacturing related expenses, research study expenses, research team expenses, and research and development related stock option compensation expense of $115,761 (a non-cash item) for the quarter ended June 30, 2021.
G&A Expenses: General and administrative expenses were $1,314,201 for the quarter ended June 30, 2021, compared to $676,399 for the quarter ended June 30, 2020. The increase was primarily attributable to expenses associated with operating as a public company and general and administrative related stock option compensation expense of $129,923 (a non-cash item) for the quarter ended June 30, 2021.
Net Loss: Net loss was $2,316,481 for the quarter ended June 30, 2021, or $0.21 per share, compared to a net loss of $833,422 for the quarter ended June 30, 2020, or $0.31 per share. The net loss for the quarter ended June 30, 2021 included $47,889 in interest income and $114,723 in other income, net, primarily attributable to a gain on loan forgiveness of Lantern’s PPP loan. The net losses include non-cash expenses related to employee stock options of $245,684 for the quarter ended June 30, 2021.
Mr. Sharma continued, "We remain steadfast in building Lantern into a best-of-breed biopharmaceutical company that blends insights from our RADR A.I. platform with the experience and expertise of our research team and a roster of collaborations with world-renowned cancer research institutions. Machine learning enabled identification and validation of molecular drivers of cancer provides the potential for more targeted and more effective oncology therapies. We are confident that our portfolio of genetically targeted oncology drug candidates can deliver significant enduring value for our shareholders."

Expected Upcoming Milestones

Clinical trial site selection for LP-300 Phase 2 trial aimed at never-smokers with NSCLC.
Data from first phase of the collaboration in GBM (Glioblastoma multiforme) with The Brain Cancer Program at Johns Hopkins University with LP-184.
Preclinical data from ATRT (atypical teratoid rhabdoid tumors) studies — an ultra rare brain cancer — also in collaboration with Johns Hopkins University with LP-184.
Additional details regarding the research collaboration in pancreatic cancer with Fox Chase Cancer Center, including data regarding efficacy in comparison with other targeted therapeutics.
Additional detailed data from the existing Phase 2 clinical trial with LP-100 that showed a median overall survival of 12.5 months for the initial 9 metastatic, castration-resistant prostate cancer patients.
Collaborations with leading research and academic centers and companies that advance our platform and our portfolio.
Data on the initial targeted indications for LP-284.
Details on the designs, efficacy and disease targets of the ADC program.
Conference Call

Toll-free US and Canada: 800–791–4813 – conference ID# 20284
International: 785–424–1102 – conference ID# 20284
Replay Number: 1-800-839–5642, no passcode — available through 11:59 pm ET on August 29, 2021.
Webcast

Live webcast will be available at: Lantern Pharma 2Q21 Earnings Call Webcast
The webcast will be archived on View Source through 11:59 pm ET on August 29, 2021.

On July 29, 2021 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three and six months ended June 30, 2021 and provided an operating forecast and program updates (Press release, Ligand, JUL 29, 2021, View Source [SID1234585361]). Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time to discuss this announcement and answer questions.

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"This is shaping up to be an outstanding year for Ligand with solid financial performance and great progress with all of our core technology platforms," said John Higgins, Chief Executive Officer of Ligand. "We are very pleased to report a smooth and efficient integration of the four acquisitions we completed last year. Through these transactions, we have added significantly to our near-term revenue generators, our R&D team has expanded considerably and we are reaping the benefits with more licensing deals. Ligand is well positioned to license our premier technologies to the industry. Now with our expanded services including both our OmniAb antibody business and our Pelican protein expression platform, we provide access to what we believe are best-in-class technology platforms with expert customer service and partner support. This year we anticipate multiple regulatory approvals of drugs based on our technologies that will drive royalty revenue in 2022 and beyond."

Second Quarter 2021 Financial Results

Total revenues for the second quarter of 2021 were a record $84.7 million, compared with $41.4 million for the same period in 2020. Royalties for the second quarter of 2021 were $8.6 million, compared with $7.2 million for the same period in 2020. Captisol sales were $62.5 million for the second quarter of 2021, compared with $24.5 million for the same period in 2020, with the increase primarily due to higher sales for use with remdesivir, a treatment for COVID-19. Contract revenue was $13.6 million for the second quarter of 2021, compared with $9.8 million for the same period in 2020, with the increase primarily due to the timing of partner milestone events and the acquisition of Pfenex in October 2020.

Cost of Captisol was $30.6 million for the second quarter of 2021, compared with $7.6 million for the same period in 2020, with the increase primarily due to higher sales of Captisol. Amortization of intangibles was $11.8 million for the second quarter of 2021, compared with $3.9 million for the same period in 2020, with the increase primarily due to amortization of contractual relationships and technologies gained through the Pfenex acquisition. Research and development expense was $16.0 million for the second quarter of 2021, compared with $12.7 million for the same period of 2020, with the increase primarily due to the addition of Pfenex expenses. General and administrative expense was $14.7 million for the second quarter of 2021, compared with $10.1 million expense for the same period in 2020, with the increase primarily due to additional expenses following the Pfenex acquisition.

Other operating income was $34.1 million for the second quarter of 2021, which represented a non-cash valuation adjustment recorded during the quarter to reduce the Pfenex CVR liability due to an expected lower probability of achieving the required milestone under the Pfenex CVR Agreement. There was no other operating income for the same period in 2020.

Net income for the second quarter of 2021 was $30.7 million, or $1.79 per diluted share, compared with net income of $22.1 million, or $1.32 per diluted share, for the same period in 2020. Net income for the second quarter of 2021 included an $(8.3) million net non-cash loss from the value of Ligand’s short-term investments, while net income for the second quarter of 2020 included a $23.5 million net non-cash gain from the value of Ligand’s short-term investments. Adjusted net income for the second quarter of 2021 was $28.0 million, or $1.63 per diluted share, compared with $16.7 million, or $1.00 per diluted share, for the same period in 2020. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

As of June 30, 2021, Ligand had cash, cash equivalents and short-term investments of $301.8 million.

Year-to-Date Financial Results

Total revenues for the six months ended June 30, 2021 were $139.8 million, compared with $74.6 million for the same period in 2020. Royalties for the six months ended June 30, 2021 were $15.7 million, compared with $13.7 million for the same period in 2020. Captisol sales were $93.8 million for the six months ended June 30, 2021, compared with $45.6 million for the same period in 2020, with the increase primarily due to higher sales for use with remdesivir. Contract revenue was $30.3 million for the six months ended June 30, 2021, compared with $15.3 million for the same period in 2020, with the increase primarily due to the timing of partner milestone events and the acquisitions of Icagen in April 2020 and Pfenex in October 2020.

Cost of goods sold was $38.7 million for the six months ended June 30, 2021, compared with $12.3 million for the same period in 2020, with the increase primarily attributable to higher sales of Captisol. Amortization of intangibles for the six months ended June 30, 2021 was $23.6 million, compared with $7.4 million for the same period in 2020, with the increase primarily due to amortization of contractual relationships and technologies grained through the Icagen and Pfenex acquisitions. Research and development expense was $33.8 million for the six months ended June 30, 2021, compared with $24.6 million for the same period of 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions. General and administrative expense was $27.0 million for the six months ended June 30, 2021, compared with $19.3 million expense for the same period in 2020, with the increase primarily due to additional expenses following the Icagen and Pfenex acquisitions.

Other operating income was $33.8 million for the six months ended June 30, 2021, which represented a non-cash valuation adjustment recorded during the period to reduce the Pfenex CVR liability due to an expected lower probability of achieving the required milestone under the Pfenex CVR Agreement. There was no other operating income for the same period in 2020.

Net income for the six months ended June 30, 2021 was $48.8 million, or $2.84 per diluted share, compared with net loss of $(2.0) million, or $(0.13) per share, for the same period in 2020. Net income for the six months ended June 30, 2021 included a $0.8 million net non-cash gain from the value of Ligand’s short-term investments, while net loss for the same period in 2020 included a net non-cash loss in the value of Ligand’s short-term investments of $(6.2) million. Adjusted net income for the six months ended June 30, 2021 was $52.3 million, or $3.04 per diluted share, compared with $31.9 million, or $1.89 per diluted share, for the same period in 2020. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

2021 Financial Guidance

Ligand is adjusting full-year 2021 guidance primarily to reflect lower expected Captisol revenue related to reduced demand for Captisol related to remdesivir which we discussed as a possibility in the first quarter 2021 earnings news release and the related earnings call. Ligand now expects full-year 2021 total revenues to be between $265 million and $275 million, and adjusted earnings per diluted share to be between $5.80 and $6.05. This compares with previous 2021 guidance for total revenues of $291 million and adjusted earnings per diluted share of $6.15.

Second Quarter 2021 and Recent Business Highlights

OmniAb Platform Updates

OmniAb is Ligand’s industry-leading, AI- and BI- (Biological Intelligence) powered multi-species antibody platform for the discovery of mono and bispecific therapeutic human antibodies. As of June 30, 2021, 19 different OmniAb-derived antibodies have been studied in approximately 77 active or completed clinical trials. Ligand expects the first regulatory approvals for OmniAb-derived antibodies in 2021.

Arcus Biosciences announced initial efficacy and safety from one of the cohorts in ARC-6, a randomized Phase 1b/2 platform study evaluating the combination of etrumadenant (dual adenosine A2a/A2b receptor antagonist) plus zimberelimab (an OmniAb-derived, anti-PD1 antibody) and docetaxel in people with taxane-naïve metastatic castration-resistant prostate cancer. Arcus also announced encouraging clinical results from an interim analysis of the Phase 2 ARC-7 study evaluating the safety and efficacy of anti-TIGIT mAb domvanalimab-based combinations with or without zimberelimab as a first-line treatment of PDL1-high non-small cell lung cancer (NSCLC). The zimberelimab monotherapy arm showed activity similar to that of marketed anti-PD-1 antibodies studied by other companies in this setting.

Janssen provided an update on their Phase 1 trial results for teclistamab in heavily pretreated patients with multiple myeloma suggesting deep and durable responses, and also announced FDA Breakthrough Therapy Designation for teclistamab for the treatment of relapsed or refractory multiple myeloma. Teclistamab is an OmniAb-derived bispecific antibody targeting BCMA and CD3.

CStone Pharmaceuticals announced OmniAb-derived anti-PD-L1 antibody sugemalimab met its primary endpoint in the first-in-class registrational clinical trial for Stage III NSCLC and plans to submit a New Drug Application in China for this expanded indication.

Aptevo Therapeutics announced positive Phase 1 clinical data for APVO436 from the dose-escalation portion of their Phase 1 trial in adults with relapsed acute myeloid leukemia, and initiation of the expansion phase of the study using the recommended dose identified in Part 1. APVO436 is an OmniAb-derived bispecific antibody targeting CD123 and CD3 for the potential treatment of hematological malignancies.

Harbour BioMed reported positive topline results for the Phase 2 proof-of-concept trial of batoclimab, a novel anti-FcRn antibody, in Chinese patients with generalized myasthenia gravis. Harbor BioMed plans to initiate a Phase 3 study in this indication in the second half of 2021.

During the second quarter, Ligand entered into OmniAb licensing agreements with GenScript Biotech and ImmuNext.

Pelican Platform Updates

The Pelican Expression Technology is Ligand’s proprietary Pseudomonas fluorescens protein expression technology that has major collaborations with Jazz Pharmaceuticals, Merck, Serum Institute of India and Alvogen, each of which has potential to contribute meaningfully to Ligand’s royalty revenue. In addition, large pharma and small biotech partners continue to expand their use of Ligand’s PeliCRM, or CRM197, a non-toxic mutant diphtheria toxin vaccine carrier protein produced using Pelican Expression Technology, adding to near-term revenue.

Jazz Pharmaceuticals recently received FDA approval for Rylaze, formerly JZP458, for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). Rylaze is a recombinant Erwinia asparaginase used as a component of a multi-agent chemotherapeutic regimen for the treatment of pediatric and adult patients with ALL or LBL who are hypersensitive to E. coli-derived asparaginase products. In July, Jazz launched Rylaze and announced that the National Comprehensive Cancer Network (NCCN) added Rylaze to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for ALL in pediatric and adult patients.

Merck received FDA approval for VAXNEUVANCE, formerly V114, for the prevention of pneumococcal disease in adults. VAXNEUVANCE is a 15-valent pneumococcal vaccine utilizing Ligand’s CRM197 vaccine carrier protein produced using the Pelican Expression Technology platform. Additionally, Merck announced positive results from initial Phase 3 pediatric clinical trials for VAXNEUVANCE in pneumococcal disease. CRM197 made in the Pelican Expression Technology is also used by Merck in its investigational vaccine candidates, including V116.

Other

BeiGene received approval in China of Kyprolis (carfilzomib) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least two prior therapies, including a proteasome inhibitor and an immunomodulatory agent. This is the first approval of Kyprolis in China. BeiGene licensed Kyprolis in 2019 for commercialization and development in China under a strategic collaboration with Amgen.

Roche and Ligand expanded an existing collaboration agreement utilizing the Icagen Ion Channel Technology platform to a third program for the development and commercialization of small molecule ion channel modulators for the treatment of neurological diseases. Roche made an upfront cash payment to Ligand and will also provide research funding. In addition, Ligand is eligible to receive up to $274 million in research, development and commercial milestone payments, as well as royalties on net sales should a drug from the collaboration be commercialized.

Travere Therapeutics announced completion of enrollment in the pivotal Phase 3 PROTECT clinical trial to evaluate the long-term nephroprotective potential of sparsentan in IgA nephropathy. Travere anticipates topline interim efficacy data in the third quarter of 2021. In May, Travere announced that the FDA indicated the available data from the interim assessment in the pivotal, Phase 3 DUPLEX study in focal segmental glomerulosclerosis would not be adequate to support an accelerated approval at this time. The FDA indicated an application for accelerated approval may be possible after additional eGFR data accrue in the first-half of 2022.

Novan announced positive topline results from the pivotal Phase 3 B-SIMPLE5 trial of SB206, a topical antiviral gel, for the treatment of molluscum contagiosum. The clinical trial achieved statistical significance (p<0.0001) for the primary endpoint of complete clearance of all lesions at Week 12, and statistical significance for all secondary endpoints including proportion achieving a lesion count of 0 or 1 at Week 12, proportion achieving ≥90% clearance of lesions at Week 12 and complete clearances of all lesions at Week 8. Novan intends to submit an NDA by the third quarter of 2022.

Sermonix Pharmaceuticals announced complete enrollment in its Phase 2 clinical trial studying lasofoxifene in combination with Eli Lilly’s FDA-approved CDK 4 and 6 inhibitor abemaciclib to treat ESR1-mutated metastatic breast and gynecological cancers. Lasofoxifene is an investigational, nonsteroidal selective estrogen receptor modulator. Sermonix expects initial data from the trial to be available in the first half of 2022.

Ligand provides regular updates on individual partner events through its Twitter account, @Ligand_LGND.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, stock-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 540-1167 from the U.S. or (929) 517-0358 from outside the U.S., using the conference ID 5089624. To participate via live or replay webcast, a link is available at www.ligand.com.

About OmniAb

The OmniAb antibody discovery platform provides Ligand’s biopharmaceutical industry partners access to the world’s most advanced antibody repertoires and screening technologies to enable unparalleled discovery of next-generation therapeutics. At the heart of the OmniAb platform is the Biological Intelligence (BI) of our proprietary transgenic animals, including OmniRat, OmniChicken and OmniMouse, each capable of generating high quality fully human antibodies that have been optimized naturally through in vivo affinity maturation. OmniFlic (transgenic rat) and OmniClic (transgenic chicken) address industry needs for bispecific antibody applications though a common light chain approach, and OmniTaur features unique structural attributes of cow antibodies for complex targets. OmniAb animals comprise the most diverse host systems available in the industry and they are optimally leveraged through AI-enhanced antigen design and immunization methods, paired with high-throughput microfluidic-based single B cell screening and deep computational analysis of next-generation sequencing datasets to identify fully human antibodies with superior performance and developability characteristics. The OmniAb suite of technologies and differentiating AI and BI features are combined to offer a highly efficient and customizable end-to-end solution for the growing antibody discovery needs of the global biopharmaceutical industry.

About the Pelican Expression Technology

Pelican is a robust, validated, cost-effective and scalable platform for recombinant protein production that is especially well-suited for complex, large-scale protein production where traditional systems are not. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, Pelican is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gilead’s VEKLURY, Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including over 40 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.