Daré Bioscience, Inc. (NASDAQ:DARE) Q1 2023 Earnings Conference Call May 11, 2023 4:30 PM ET Company Participants Sabrina Martucci Johnson – President and Chief Executive Officer John Fair – Chief Commercial Officer Lisa Walters-Hoffert – Chief Financial Officer Conference Call Participants Catherine Novack – Jones Research Kumar Raja – ROTH Capital Kemp Dolliver – Brookline Capital Markets Doug Tsao – H.C. Wainwright Operator Welcome to the conference call hosted by Daré Bioscience to review the Company’s ...

Financial Performance - Net loss for the three months ended March 31, 2023, was $8.04 million, compared to a net loss of $8.40 million for the same period in 2022, indicating a reduction in loss of about 4.3%[17] - The company reported a comprehensive loss of $8.06 million for the three months ended March 31, 2023, compared to a comprehensive loss of $8.41 million for the same period in 2022, a decrease of about 4.2%[17] - For the three months ended March 31, 2023, the company reported a net loss of approximately $8.0 million, compared to a net loss of $8.4 million for the same period in 2022, representing a 4.3% improvement in net loss year-over-year[33] Assets and Liabilities - Total current assets decreased from $43.04 million as of December 31, 2022, to $29.51 million as of March 31, 2023, representing a decline of approximately 31.2%[16] - Total assets decreased from $43.83 million as of December 31, 2022, to $30.37 million as of March 31, 2023, a reduction of about 30.7%[16] - Total liabilities decreased from $32.71 million as of December 31, 2022, to $25.40 million as of March 31, 2023, reflecting a decrease of approximately 22.3%[16] Cash Flow - Cash and cash equivalents decreased from $34.67 million as of December 31, 2022, to $19.83 million as of March 31, 2023, a decline of about 42.7%[16] - The net cash used in operating activities for the three months ended March 31, 2023, was approximately $16.1 million, an increase of 30.4% compared to $12.3 million for the same period in 2022[33] - The company reported a net change in cash and cash equivalents of approximately $(14.8) million for the three months ended March 31, 2023[33] - As of March 31, 2023, the company had cash and cash equivalents of approximately $19.8 million, down from $39.3 million at the end of the previous year, indicating a decrease of 49.7%[33] Operating Expenses - Operating expenses for the three months ended March 31, 2023, were $8.38 million, slightly down from $8.40 million in the same period of 2022, showing a decrease of approximately 0.2%[17] - General and administrative expenses increased from $2.57 million in Q1 2022 to $3.34 million in Q1 2023, an increase of approximately 29.8%[17] - Research and development expenses decreased from $5.81 million in Q1 2022 to $5.02 million in Q1 2023, a reduction of about 13.6%[17] Revenue Generation - The company recognized $10.0 million in license fee revenue from its agreement for XACIATO, which was the only revenue recognized as of March 31, 2023[44] - The company has not recognized any collaboration revenues as of March 31, 2023, indicating limited revenue generation from partnerships[43] Capital Needs and Future Outlook - The company expects to continue incurring negative cash flows from operations for the foreseeable future, necessitating substantial additional capital to fund operations and execute its strategy[34] - The company will need to raise substantial additional capital to continue its operations and may face significant operational adjustments if capital is not available[35] Stock and Equity - The weighted average number of shares outstanding increased from 83.94 million in Q1 2022 to 85.52 million in Q1 2023, an increase of approximately 1.9%[17] - The Company entered into a sales agreement to sell up to $50.0 million of common stock through an ATM equity offering program, with no shares sold during the three months ended March 31, 2023[85][86] - As of March 31, 2023, the Company had 9,110,219 stock options outstanding with a weighted average exercise price of $1.48[97] Milestone Payments and Agreements - The Company is entitled to receive up to $310.0 million in milestone payments related to the commercial sales of Ovaprene, along with tiered royalties starting in the low double digits based on annual net sales[49] - An exclusive license agreement with Organon resulted in a $10.0 million non-refundable payment, with potential milestone payments totaling up to $182.5 million and tiered double-digit royalties based on net sales[52][53] - The Company has potential future payments of up to $6.25 million for development and regulatory milestones and up to $45.0 million for commercial sales milestones under the Hennepin License Agreement[64] - The acquisition of Dare MB Inc. included contingent payments of up to $46.5 million for specified milestones and up to $55.0 million based on aggregate net sales of products[66] - The Company has paid $1.25 million in milestone payments related to the MBI acquisition, with a portion paid in shares of common stock[67] - The Pear Tree acquisition includes potential payments of up to $15.5 million for clinical development milestones and up to $47.0 million for commercial milestones, along with tiered royalties based on net sales[72] Grant Funding and Non-Dilutive Funding - The Company received a grant of $585,000 from the Bill & Melinda Gates Foundation for the development of DARE-LBT, with a deferred grant funding liability of approximately $552,000 recorded as of March 31, 2023[117][118] - Cumulative total of approximately $23.9 million in non-dilutive funding received under the DARE-LARC1 agreement, with a deferred grant funding liability of approximately $15.3 million as of March 31, 2023[120] Lease Obligations - The Company reported operating lease right of use assets of approximately $368,000 as of March 31, 2023[104] - Total operating lease costs for Q1 2023 were approximately $139,000, down from $169,000 in Q1 2022, representing a decrease of about 17.8%[105] - Cash paid for operating lease liabilities was approximately $105,000 in Q1 2023, compared to $123,000 in Q1 2022, indicating a decrease of approximately 14.6%[106] - Future minimum lease payments under operating leases total $410,000, with $317,000 due in the remainder of 2023 and $93,000 in 2024[106]

Financial Data and Key Metrics Changes - The comprehensive loss for 2022 was approximately $31.1 million, with cash and cash equivalents at approximately $34.7 million at year-end [64] - The company received approximately $24.1 million in non-dilutive funding during the year, including a $10 million license fee from Organon [64][63] - General and administrative expenses were approximately $11.2 million, while research and development expenses were approximately $30 million [79] Business Line Data and Key Metrics Changes - The company has secured its second commercial collaboration for XACIATO with Organon and received FDA acceptance for the pivotal study of Ovaprene [6][41] - Enrollment was completed for the Sildenafil Cream Phase IIb study, with positive results from two Phase I/II studies for DARE-VVA1 and DARE-HRT1 [6][24] Market Data and Key Metrics Changes - Women's health products represent 27% of blockbuster products generating over $500 million in annual sales, contributing 35% of revenue from all blockbuster products [7] - The global market for dysmenorrhea treatment is estimated to be valued at $13 billion in 2022, expected to increase to $28 billion by 2029 [52] Company Strategy and Development Direction - The company focuses solely on women's health, with 12 independent development stage candidates, claiming to have the deepest pipeline in this area [13] - The strategy includes prioritizing candidates that address meaningful market opportunities and have the potential to be first-in-category products [15] - The company aims to leverage collaborations with established commercial partners like Organon and Bayer to enhance market access and commercialization efforts [56][61] Management's Comments on Operating Environment and Future Outlook - Management believes that investment in women's health is efficient and impactful, addressing significant unmet needs in the market [5][14] - The company anticipates achieving additional commercialization, clinical, and regulatory milestones in 2023, with several key programs progressing [34] Other Important Information - The company is focused on developing differentiated first-line or first-in-category products, allowing flexibility in commercialization strategies [56] - The FDA's 505(b)(2) pathway will be utilized for obtaining marketing approvals for several products, including DARE-HRT1 and DARE-VVA1 [26][51] Q&A Session Summary Question: Can you discuss the components going into the arousal sensation domains and what would be considered a clinically meaningful improvement? - The study includes various exploratory endpoints to assess clinically meaningful improvements, with a focus on patient-reported outcomes [69][101] Question: How is the commercialization strategy for Sildenafil Cream being developed? - The company evaluates each product individually, considering the best approach for development and commercialization based on the product's needs and market conditions [86][91] Question: How do the doses being tested for DARE-PDM1 compare with systemically dosed versions? - The study is designed to understand the localized effects of diclofenac, with a focus on achieving effective concentrations in the targeted tissue [95][107]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________________ FORM 10-K ___________________________________________________ ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM _____ TO_____ Commission File No. 001-36395 DARÉ BIOSCIENCE, INC. (Exa ...

Dare Bioscience, Inc. (NASDAQ:DARE) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Sabrina Johnson - President and Chief Executive Officer Lisa Walters-Hoffert - Chief Financial Officer John Fair - Chief Strategy Officer Conference Call Participants Kumaraguru Raja - ROTH Capital Operator Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended September 30, 2022 and to provide a general business update. This ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36395 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of I ...

Dare Bioscience, Inc. (NASDAQ:DARE) Q2 2022 Earnings Conference Call August 9, 2022 4:30 PM ET Company Participants Sabrina Johnson - President, CEO, Secretary & Director John A. Fair - Chief Strategy Officer Lisa Walters-Hoffert - CFO Conference Call Participants Operator Good . My name is Joanne, and I will be your conference operator today. At this time, I would like to welcome everyone to the Dare Bioscience, Inc. Q2 2022 Conference Call. [Operator Instructions]. Ms. Johnson, you may begin your conferen ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36395 DARÉ BIOSCIENCE, INC. (Exact Name of Registrant as Specified in its Charter) Delaware (State or Other Jurisdiction of Incorp ...

Dare Bioscience, Inc. (NASDAQ:DARE) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Sabrina Martucci Johnson - President and Chief Executive Officer John Fair - Chief Strategy Officer Lisa Walters-Hoffert - Chief Financial Officer Conference Call Participants Zegbah Jallah - ROTH Capital Partners Douglas Tsao - H.C. Wainwright Kumaraguru Raja - Brookline Capital Markets Operator Welcome to the conference call hosted by Dare Bioscience to review the company's financial results f ...

Financial Performance - Net loss for the three months ended March 31, 2022, was $8,398,670, compared to a net loss of $7,323,644 for the same period in 2021, indicating an increase in loss of about 14.7%[14] - Total operating expenses for the three months ended March 31, 2022, were $8,400,449, up from $7,693,534 in the same period of 2021, marking an increase of approximately 9.2%[14] - The company reported a loss per common share of $0.10 for the three months ended March 31, 2022, compared to a loss per common share of $0.16 for the same period in 2021[14] - For the three months ended March 31, 2022, the company incurred a net loss of approximately $8.4 million, compared to a net loss of approximately $7.3 million for the same period in 2021[32] - The company reported negative cash flow from operations of approximately $12.3 million for the three months ended March 31, 2022, an increase from negative cash flow of approximately $8.4 million in the prior year[32] Assets and Liabilities - Total current assets decreased from $55,296,016 as of December 31, 2021, to $47,817,188 as of March 31, 2022, representing a decline of approximately 13.4%[12] - Total liabilities increased from $17,052,856 as of December 31, 2021, to $18,307,672 as of March 31, 2022, reflecting a rise of approximately 7.4%[12] - Cash and cash equivalents decreased from $51,674,087 as of December 31, 2021, to $39,316,911 as of March 31, 2022, a reduction of about 23.9%[12] - The accumulated deficit increased from $110,126,902 as of December 31, 2021, to $118,525,572 as of March 31, 2022, representing a rise of about 7.8%[12] - Total stockholders' equity decreased from $38,754,321 as of December 31, 2021, to $30,878,910 as of March 31, 2022, a decline of about 20.4%[12] Shareholder Information - The weighted average number of common shares outstanding increased from 44,502,582 for the three months ended March 31, 2021, to 83,944,119 for the same period in 2022, indicating a significant increase of approximately 88.5%[14] - As of March 31, 2022, the Company had outstanding warrants for 1,374,515 shares at an exercise price of $0.96, expiring on February 15, 2023[99] - The Company has approximately 27 million authorized shares of common stock available for issuance as of the date of the report[36] Research and Development - Research and development expenses for the three months ended March 31, 2022, were $5,805,462, slightly up from $5,728,206 in the same period of 2021, reflecting an increase of approximately 1.4%[14] - The company expects significant increases in research and development expenses in 2022 compared to 2021 as it continues to develop its product candidates[34] - The Company has not generated any revenue to date and primarily focuses on research and development activities[25] Licensing and Collaboration Agreements - The Company entered into an exclusive license agreement with Organon, receiving a non-refundable upfront payment of $10.0 million and potential milestone payments up to $182.5 million[52][53][54] - The royalty payments from Organon will be tiered double-digit percentages based on net sales, continuing until the expiration of patent claims or 10 years after the first commercial sale in each country[54][55] - The license agreement with Bayer includes a $1.0 million upfront payment and potential milestone payments totaling up to $310.0 million based on sales achievements[59][61] - The Company has a strategic agreement with Hammock Pharmaceuticals, involving milestone payments up to $1.1 million for clinical and regulatory achievements[64][66] - The Company has incurred $235,000 in license fees payable to MilanaPharm, with additional milestone payments based on commercial sales[64][66] Financial Obligations and Future Funding - The Company anticipates needing to raise substantial additional capital to fund its operations and execute its current strategy[36] - The Company is committed to a total of $5.5 million in payments to NICHD for the Ovaprene Phase 3 study, with $5.0 million already paid as of March 31, 2022[111] - The Company agreed to pay up to $46.5 million in contingent consideration to former MBI stockholders based on achieving specific milestones, with $1.25 million already payable as of June 2021[112] Grants and Non-Dilutive Funding - The Company received approximately $1.9 million in non-dilutive grant funding from NICHD for Ovaprene development from 2018 to 2021[116] - A grant of $300,000 was awarded by NICHD for the development of DARE-PTB1, with potential additional funding of up to $2.0 million contingent on Phase I results[117] - The Company entered into a new grant agreement with the Foundation in June 2021 for up to $48.95 million to support DARE-LARC1 development, with an initial payment of $11.45 million received in July 2021[121] Acquisitions - The Company acquired Dare MB Inc. for $2.4 million, issuing approximately 3.0 million shares valued at $0.79 per share, to develop a long-acting reversible contraception method[86] - The Company completed the acquisition of Pear Tree Pharmaceuticals to develop a proprietary vaginal formulation of tamoxifen, with contingent payments based on clinical, regulatory, and commercial milestones[89] Clinical Studies - The Company commenced a Phase 1/2 clinical study of DARE-HRT1 in April 2022, evaluating pharmacokinetics in approximately 20 healthy, postmenopausal women[124]