Puma Biotechnology Secures Athyrium Capital Purchase of $ 125 Million Bill

THE ANGEL–(BUSINESS WIRE) – Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced a bond purchase agreement with a fund owned by Athyrium Capital Management, LP, a specialist asset management company focused on global healthcare opportunities, known for issuing debt securities valued at up to $ 125 million, subject to funding in two tranches.

Puma has received gross proceeds of $ 100 million from the first tranche of the Notes issued by Puma under the Debt Purchase Agreement at closing on July 23 and intends to use the funds along with the cash to repay its existing loan with Oxford Finance LLC . The second tranche of $ 25 million can be drawn at a later date; in the event of a withdrawal, these proceeds would be used for general corporate purposes and to further support NERLYNX®’s commercial initiatives. Armentum Partners acted as financial advisor to the company in connection with the promissory note purchase agreement. The bonds mature in July 2026. Additional information regarding the Schuldschein agreement will be filed with the Securities and Exchange Commission as an updated report on Form 8-K.

Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma Biotechnology, said, “We are pleased to complete this bond purchase transaction with Athyrium Capital and to have your support in further commercializing NERLYNX. This funding will be used to continue to support NERLYNX’s commercial activities and ongoing research with neratinib. ”

“We are excited to partner with Puma Biotechnology to support NERLYNX in its current indications as well as in its clinical development programs for additional indications,” said Laurent D. Hermouet, partner at Athyrium. “Given the company’s track record of in-licensing successes, we are also excited about the potential to fund inorganic growth activities such as the company may offer.”

About Athyrium Capital Management, LP

Athyrium Capital Management, LP is a specialist asset management company founded in 2008 to focus on investment opportunities in the global healthcare sector. Athyrium advises funds with over $ 4.6 billion in committed capital. The Athyrium team has extensive investment experience in a variety of asset classes, including public equity, private equity, fixed income, royalties and other structured securities. Athyrium invests in all healthcare industries, including biopharmaceuticals, medical devices and products, health-related services, and healthcare information technology. The team works with management teams to implement creative financing solutions for companies’ capital needs.

About Puma Biotechnology

Puma Biotechnology, Inc. is a biopharmaceutical company focused on developing and commercializing innovative products that improve cancer care. Puma licenses the worldwide development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Oral neratinib was approved by the US Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with HER2-overexpressed / amplified early-stage breast cancer following adjuvant trastuzumab-based therapy and is known as NERLYNX® in the US. marketed (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA in combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who had previously received two or more anti-HER2-based therapies in the metastatic setting. NERLYNX received marketing authorization from the European Commission in 2018 for the extended adjuvant treatment of adult patients with hormone-receptor-positive HER2-overexpressed / amplified early-stage breast cancer less than a year after completion of previous adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

More information about Puma Biotechnology can be found at www.pumabiotechnology.com.

IMPORTANT SAFETY INSTRUCTIONS

NERLYNX® (neratinib) tablets, for oral use

INDICATIONS AND APPLICATION: NERLYNX is a kinase inhibitor which is indicated:

  • As a single active ingredient for the extended adjuvant treatment of adult patients with HER2-positive breast cancer in the early stages following adjuvant trastuzumab-based therapy.

  • In combination with capecitabine for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have previously received two or more anti-HER2-based regimens in the metastatic setting.

CONTRAINDICATIONS: None

WARNINGS AND PRECAUTIONS:

  • Diarrhea: Treat diarrhea with either NERLYNX dose escalation or loperamide prophylaxis. If diarrhea occurs despite a dose increase or loperamide dose, treat treatment with loperamide, additional antidiarrheal drugs, fluids, and electrolytes as clinically indicated. Discontinue NERLYNX in patients with severe and / or persistent diarrhea. Permanently discontinue NERLYNX in patients with Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after a maximum dose reduction.

  • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months during treatment and as clinically indicated. NERLYNX should be discontinued in patients with Grade 3 liver abnormalities and NERLYNX should be permanently discontinued in patients with Grade 4 liver abnormalities.

  • Embryo-fetal toxicity: NERLYNX can cause fetal damage. Advise patients of a potential risk to the fetus and use effective contraception.

SIDE EFFECTS:

The most common side effects (reported in ≥ 5% of patients) were:

  • NERLYNX as a single active ingredient: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle cramps, dyspepsia, increased AST or ALT values, nail disease, dry skin, bloated stomach, epistaxis, weight loss and urinary tract infection.

  • NERLYNX in combination with capecitabine: diarrhea, nausea, vomiting, loss of appetite, constipation, fatigue / asthenia, weight loss, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, flatulence, kidney dysfunction and muscle cramps.

To report suspected side effects, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or the FDA at 1-800-FDA-1088 or www.fda.gov/ medwatch.

INTERACTIONS WITH OTHER DRUGS:

  • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. Separate NERLYNX with antacids for at least 3 hours. Disconnect NERLYNX at least 2 hours before or 10 hours after H2 receptor antagonists. Or separate NERLYNX by at least 3 hours with antacids.

  • Strong CYP3A4 inhibitors: Avoid simultaneous use.

  • P-gp and moderate CYP3A4 dual inhibitors: Avoid concomitant use.

  • Strong or moderate CYP3A4 inducers: Avoid simultaneous use.

  • Certain P-gp substrates: Monitor for side effects of P-gp substrates where a minimal change in concentration when used concomitantly with NERLYNX could result in serious side effects.

USE IN CERTAIN POPULATIONS:

  • Breast-feeding: Advise women not to breast-feed.

See full prescribing information for additional safety information.

To ensure patients have access to NERLYNX, Puma implemented the Puma Patient Lynx Support Program to provide patients and healthcare providers with reimbursement support and referral to resources that can help with financial support. For more information on the Puma Patient Lynx program, please visit www.NERLYNX.com or 1-855-816-5421.

Forward-looking statement

This press release contains forward-looking statements that involve risks and uncertainties that could cause Puma’s actual results to differ materially from the expected results and expectations expressed in these forward-looking statements. These statements are based on current expectations, projections and assumptions and actual results and results could differ materially from these statements due to a number of factors including, but not limited to, the adverse effect on Puma’s business or the global economy and financial markets generally from the global COVID -19 Pandemic and the Risk Factors disclosed in the periodic and timely reports that Puma files from time to time with the Securities and Exchange Commission, including Puma’s Annual Report on Form 10-K for the year ends December 31, 2020. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Puma assumes no obligation to update these forward-looking statements unless required by law.