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Aytu BioPharma(AYTU) - 2019 Q3 - Earnings Call Transcript
2019-05-14 18:52
Financial Data and Key Metrics Changes - The company achieved an all-time high net revenue of approximately $2.4 million for the quarter ending March 31, 2019, representing a sequential growth of 33% and nearly 300% year-over-year [5][6][12] - Gross profit for Q3 2019 was $1.76 million, a 39% sequential increase from $1.27 million in Q2 [13] - The operating loss for Q3 2019 was $4.3 million, lower than the $4.6 million reported in Q2 and 43% lower than the same quarter last year [13] - The company ended the quarter with a cash balance of $14.75 million, down from $17.9 million at the end of Q2 [14] Business Line Data and Key Metrics Changes - Natesto continued to be the primary revenue driver, with revenue growth exceeding 380% year-over-year, supported by increased prescriptions and units shipped [7][8] - Tuzistra XR was launched through the sales force, with expectations for improved performance in the upcoming cough season [9][10] - ZolpiMist contributed solid revenue in its first full quarter with the sales force, and the company plans to shift focus towards ZolpiMist as the cough season winds down [9][10] Market Data and Key Metrics Changes - The company is expanding its distribution network for MiOXSYS, which is now used in over 30 countries, with approvals in Canada, the EU, Australia, and Mexico [10][11] - The partnership with SUDA Pharmaceuticals for ZolpiMist allows the company to benefit from sales outside the U.S. and Canada, with sublicensing deals already established in major markets [21] Company Strategy and Development Direction - The company aims to double revenues year-over-year and is focused on maintaining momentum with its product portfolio, particularly Natesto, ZolpiMist, and Tuzistra [5][16] - The management is optimistic about the upcoming cough season and expects to leverage the advantages of Tuzistra being a Schedule III product [26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's current momentum and the potential for continued growth, particularly with the upcoming cough season and the performance of Natesto [5][16] - The company anticipates a more balanced portfolio in the future, with significant contributions expected from ZolpiMist and Tuzistra alongside Natesto [28] Other Important Information - The company eliminated all outstanding interest-bearing debt through an exchange transaction with Armistice Capital, enhancing its financial position [14] - The Natesto Spermatogenesis Study is progressing well, with interim data published indicating no adverse effects on fertility, which could position Natesto uniquely in the testosterone treatment market [17][19] Q&A Session Summary Question: Can you talk about the schedule for Tuzistra and its advantages? - Management highlighted that Tuzistra XR is classified as Schedule III, providing a significant market advantage over Schedule II products, making it easier for physicians to prescribe [24][26] Question: Can you discuss the expected product mix over the next several quarters? - Management expects Natesto to remain a significant revenue contributor, but anticipates a more balanced portfolio with meaningful contributions from ZolpiMist and Tuzistra [28][29] Question: What are the expectations for sequential growth? - Management does not provide specific guidance but expects continued strong growth year-over-year, with seasonal factors influencing quarterly dynamics [31] Question: Can you comment on sequential total prescription growth for Natesto? - Management confirmed strong sequential growth in prescriptions for Natesto, indicating a positive trend in sustaining therapy among patients [35] Question: What is the timing for the top-line readout of the Spermatogenesis Study? - The study is expected to wrap up in June/July, with results likely to be presented at a high-impact scientific conference [38]
Aytu BioPharma(AYTU) - 2019 Q3 - Quarterly Report
2019-05-14 12:07
Financial Performance - Aytu BioScience reported a net revenue of $2.4 million for the three months ended March 31, 2019, compared to $607,000 for the same period in 2018, representing a significant increase [109]. - For the nine months ended March 31, 2019, net revenue reached $5.6 million, up from $2.7 million in the prior year, indicating a growth of 106% [109]. - The company experienced a net loss of approximately $12.6 million for the nine months ended March 31, 2019, compared to a loss of $10.7 million for the same period in 2018 [107]. - Aytu BioScience's accumulated deficit stood at $91.9 million as of March 31, 2019 [99]. - The cost of sales for the three months ended March 31, 2019, was $617,000, down from $1.1 million in the same period in 2018 [113]. - Aytu BioScience's gross product revenue for the three months ended March 31, 2019, was $3.36 million, with net product revenue of $2.37 million after deductions [111]. Expenses and Cash Flow - Research and development expenses increased by $436,000, or 1,981.8%, for the nine months ended March 31, 2019, compared to the same period in 2018 [114]. - Selling, general and administrative costs increased by $738,000, or 15.9%, for the three months ended March 31, 2019, compared to the same period in 2018 [116]. - The company used $10.4 million in cash for operating activities during the nine months ended March 31, 2019, which was less than the reported net loss of $12.6 million [118]. - Cash used in investing activities was $860,000 during the nine months ended March 31, 2019, for purchasing fixed and operating assets [120]. - Cash use in operating activities during the nine months ended March 31, 2018, was $11.4 million [119]. Financing Activities - The company raised gross proceeds of $15.2 million from a public offering completed on October 9, 2018 [95]. - Net cash provided by financing activities was $19.0 million for the nine months ended March 31, 2019, primarily due to a public offering of $15.2 million [122]. - The company received proceeds of $259,000 from warrant exercises during the nine months ended March 31, 2019 [122]. Strategic Plans - The company plans to expand into other therapeutic areas as part of its growth strategy [94]. - The company expects selling, general and administrative expenses to increase slightly in the remainder of fiscal 2019 due to expanding the sales team and launching Tuzistra XR [116]. Asset Management - Amortization of intangible assets increased to $575,000 for the three months ended March 31, 2019, compared to $388,000 for the same period in 2018 [117]. - The impairment expense recognized in the three and nine months ended March 31, 2018, was $1,856,000 related to Aytu Women's Health assets [116]. - The company does not have off-balance sheet arrangements or material market risk exposure from financial instruments [124]. Product Portfolio - Aytu BioScience's product portfolio includes Natesto, Tuzistra XR, ZolpiMist, and MiOXSYS, with Natesto being the primary revenue driver [109].
Aytu BioPharma(AYTU) - 2019 Q2 - Earnings Call Transcript
2019-02-07 17:46
Financial Data and Key Metrics Changes - The company reported record revenue of $1.8 million for Q2 2019, representing a 71% increase year-over-year and a 25% increase sequentially from Q1 2019 [6][18][19] - Year-to-date revenue reached $3.2 million, which is 52% higher than the same period last year [19] - Gross profit for Q2 was approximately $1.3 million, nearly double the gross profit reported for Q2 last year [19] - The net loss for the year-to-date period was $8.1 million, compared to a loss of $7.9 million for the same period last year [22] Business Line Data and Key Metrics Changes - Natesto was the primary revenue contributor, with total prescriptions increasing by 27% sequentially and achieving all-time weekly highs in December [11][19] - ZolpiMist launched into its first full quarter, with expectations for meaningful revenue growth going forward [12] - Tuzistra XR was launched through the sales force, showing rapid script growth in the early weeks of promotion [13][15] Market Data and Key Metrics Changes - The company is expanding its commercial portfolio in the $3 billion prescription cough suppressant market with Tuzistra XR [7][14] - MiOXSYS, the diagnostic platform for male infertility, is gaining traction in over 30 countries and is supported by reputable fertility thought leaders [16] Company Strategy and Development Direction - The company aims to leverage its diversified product portfolio to drive revenue growth, focusing on Natesto, ZolpiMist, and Tuzistra XR [15][30] - Aytu BioScience is not actively seeking new acquisitions but remains open to opportunities that align with its current product mix [42][43] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in continued revenue growth and operational efficiency, expecting to maintain a stable operating expense structure [40][50] - The company anticipates a strong flu season, which may positively impact Tuzistra XR's launch [48] Other Important Information - The company successfully closed a $15 million equity offering and a $5 million strategic investment, significantly strengthening its balance sheet [8][22][24] - The Natesto Spermatogenesis Study is showing promising interim results, with potential implications for testosterone replacement therapy [27][29] Q&A Session Summary Question: Can you provide more details about the other cough suppressant filing? - The company is cautious about disclosing details but confirmed it is a complementary antitussive product currently under FDA review, with a near-term opportunity expected [33] Question: What is the expected severity of the new cough suppressant compared to Tuzistra? - The new product is expected to address slightly more severe cases but will not significantly change its position in the treatment paradigm [36] Question: What is the outlook for operating expenses relative to revenue growth? - Management expects to continue leveraging operating expenses effectively, maintaining a stable cost structure while growing revenue [40] Question: Any updates on M&A activity? - The company is satisfied with its current portfolio and is not actively seeking new acquisitions but remains open to opportunities that do not require significant upfront costs [42][43] Question: What is the expected cash burn for the second half of the year? - The company anticipates a decrease in cash burn as revenue grows, with a stable operating expense base [48][50]
Aytu BioPharma(AYTU) - 2019 Q2 - Quarterly Report
2019-02-07 13:42
Financial Performance - Aytu BioScience reported a net revenue of $1.8 million for the three months ended December 31, 2018, compared to $1.1 million for the same period in 2017, reflecting a growth of 63.6%[101] - The company achieved a net revenue of $3.2 million for the six months ended December 31, 2018, up from $2.1 million in the prior year, representing a growth of 52.4%[101] - Aytu incurred a net loss of approximately $4.7 million for the three months ended December 31, 2018, compared to a loss of $3.7 million for the same period in 2017[98] - The accumulated deficit as of December 31, 2018, was $87.4 million, indicating ongoing financial challenges since inception[92] - Aytu's gross product revenue for the three months ended December 31, 2018, was $3.37 million, with a net product revenue of $1.8 million after deductions[103] Expenses and Costs - Research and development expenses increased by $426,000, or 153.8%, for the three months ended December 31, 2018, compared to the same period in 2017[105] - The company anticipates an increase in operating expenses due to start-up costs related to the launch of Tuzistra XR and expansion of its sales team[95] - Selling, general and administrative costs increased by $585,000, or 12.8%, for the three months ended December 31, 2018, compared to the same period in 2017[107] - Selling, general and administrative costs decreased by $204,000, or 2.2%, for the six months ended December 31, 2018, compared to the same period in 2017[107] - The company expects selling, general and administrative expenses to increase slightly in the remainder of fiscal 2019 due to expanding the sales team and launching Tuzistra XR[107] - Professional fees decreased due to reduced use of outside accounting firms, contributing to the overall decrease in selling, general and administrative costs[107] Cash Flow and Financing - Net cash used in operating activities during the six months ended December 31, 2018 was $7.0 million, lower than the reported net loss of $8.1 million[109] - Net cash provided by financing activities in the six months ended December 31, 2018 was $18.7 million, primarily from a public offering of $15.2 million[113] - The company raised gross proceeds of $15.2 million from a public offering in October 2018, which is expected to support its operational needs[88] - The company closed on a debt agreement for $5.0 million during the six months ended December 31, 2018[113] Cash Position - Aytu's cash, cash equivalents, and restricted cash totaled $17.9 million as of December 31, 2018, providing a buffer for operational expenses[92] - Cash used for investing activities during the six months ended December 31, 2018 was $860,000, primarily for purchasing fixed and operating assets[111] Other Information - The company does not have off-balance sheet arrangements or material market risk exposure from financial instruments[115][116] - Amortization of intangible assets increased to $534,000 for the three months ended December 31, 2018, compared to $384,000 for the same period in 2017[108] - The company plans to expand into other therapeutic areas as part of its growth strategy, focusing on significant patient needs[87]